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    {"id":"2407","name":"Pfizer withdraws its marketing authorisation application for Exulett (dalbavancin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-10T02:09:21Z","last_updated_date":"2008-09-10T02:09:21Z","reference_number":"EMEA/476868/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/pfizer-withdraws-its-marketing-authorisation-application-exulett-dalbavancin_en.pdf"},
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    {"id":"2461","name":"Committee for Proprietary Medicinal Products (CPMP) 57th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-02-21T01:00:00Z","last_updated_date":"2000-02-21T01:00:00Z","reference_number":"CPMP/316/00 corr.","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-57th-plenary-meeting_en.pdf"},
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    {"id":"2466","name":"Opinion following an Article 33 referral for  Ecomectin 18.7 mg/g Oral Paste for Horses and its associated names International Non-Proprietary Name (INN): Ivermectin: Background 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    {"id":"2594","name":"Final list of references supporting the assessment of Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et Arn., Grindelia camporum Greene, herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-03-11T11:00:00Z","last_updated_date":"2013-03-11T11:00:00Z","reference_number":"EMA/HMPC/748221/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-grindelia-robusta-nutt-grindelia-squarrosa-pursh-dunal-grindelia-humilis-hook-et-arn-grindelia-camporum-greene-herba_en.pdf"},
    {"id":"2597","name":"Concept paper on the development of a Committee for Medicinal Products for Human Use (CHMP) guideline on the in-vitro investigation of mitochondrial toxicity of anti-HIV medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T01:00:00Z","last_updated_date":"2008-01-24T01:00:00Z","reference_number":"EMEA/CHMP/SWP/151915/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-medicinal-products-human-use-chmp-guideline-vitro-investigation-mitochondrial-toxicity-anti-hiv-medicinal-products_en.pdf"},
    {"id":"2598","name":"Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-15T02:00:00Z","last_updated_date":"2016-10-18T12:49:00Z","reference_number":"EMA/681144/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/olodaterol-list-nationally-authorised-medicinal-products-psusa00010245201503_en.pdf"},
    {"id":"2599","name":"CHMP post-authorisation summary of positive opinion for ProQuad","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T13:00:00Z","last_updated_date":"2012-03-16T13:00:00Z","reference_number":"EMA/CHMP/168236/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-proquad_en.pdf"},
    {"id":"2601","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for the prevention of cytomegalovirus dis...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T12:30:00Z","last_updated_date":"2015-02-23T12:30:00Z","reference_number":"EMA/627266/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-covalently-closed-dna-plasmids-coding-cytomegalovirus-phosphoprotein-65-and-glycoprotein-b-genes-prevention-cytomegalovirus-dis_en.pdf"},
    {"id":"2602","name":"Presentation – Cystic fibrosis workshop - Pre-work package","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-13T00:00:00Z","last_updated_date":"2017-10-13T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cystic-fibrosis-workshop-pre-work-package_en.pdf"},
    {"id":"2603","name":"ICH: Q 1 B: Photostability testing of new active substances and medicinal products - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-01-01T01:00:00Z","last_updated_date":"1998-01-01T01:00:00Z","reference_number":"CPMP/ICH/279/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-b-photostability-testing-new-active-substances-and-medicinal-products-step-5_en.pdf"},
    {"id":"2604","name":"Application form for the involvement of industry stakeholder organisations in the activities of the European Medicines Agency (EMA)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-09-12T16:40:00Z","last_updated_date":"2019-03-05T09:30:00Z","reference_number":"EMA/379033/2016","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-form-involvement-industry-stakeholder-organisations-activities-european-medicines-agency-ema_en.pdf"},
    {"id":"2607","name":"Presentation - Highlights of 2017 (M. Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T15:44:00Z","last_updated_date":"2017-12-11T15:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-highlights-2017-m-mavris_en.pdf"},
    {"id":"2608","name":"European Medicines Agency's 20th anniversary - Timeline","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-26T01:00:00Z","last_updated_date":"2015-01-29T13:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-20th-anniversary-timeline_en.pdf"},
    {"id":"2609","name":"European Medicines Agency expert meeting on human transmissible spongiform encephalopathies and medicinal products derived from human blood and plasma, 1 December 2000: Summary report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2001-03-28T02:09:21Z","last_updated_date":"2001-03-28T02:09:21Z","reference_number":"EMEA/CPMP/BWP/450/01","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-expert-meeting-human-transmissible-spongiform-encephalopathies-and-medicinal-products-derived-human-blood-and-plasma-1-december-2000-summary-report_en.pdf"},
    {"id":"2610","name":"EU/3/15/1565: Public summary of opinion on orphan designation: 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-18T11:00:00Z","last_updated_date":"2015-11-18T11:00:00Z","reference_number":"EMA/COMP/614807/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151565-public-summary-opinion-orphan-designation-2-chloro-n6-3-iodobenzyladenosine-5-n-methyluronamide-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"2611","name":"Guidelines on good pharmacovigilance practices: Introductory cover note to finalisation of the first seven modules and public consultation of draft modules III and X","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T19:24:00Z","last_updated_date":"2012-06-25T19:24:00Z","reference_number":"EMA/426200/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-introductory-cover-note-finalisation-first-seven-modules-and-public-consultation-draft-modules-iii-and-x_en.pdf"},
    {"id":"2612","name":"EU/3/10/819: Public summary of opinion on orphan designation: Human heterologous liver cells (for infusion) for the treatment of hyperargininaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-19T01:00:00Z","last_updated_date":"2011-01-19T01:00:00Z","reference_number":"EMA/COMP/636058/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310819-public-summary-opinion-orphan-designation-human-heterologous-liver-cells-infusion-treatment-hyperargininaemia_en.pdf"},
    {"id":"2614","name":"CHMP summary of positive opinion for Oxervate","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T12:00:00Z","last_updated_date":"2017-05-19T12:00:00Z","reference_number":"EMA/CHMP/297602/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-oxervate_en.pdf"},
    {"id":"2615","name":"Cefacetrile: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/754/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefacetrile-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"2617","name":"European Medicines Agency recommends restricting use of tolperisone medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T12:00:00Z","last_updated_date":"2012-06-22T12:00:00Z","reference_number":"EMA/CHMP/406866/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-tolperisone-medicines_en.pdf"},
    {"id":"2618","name":"Presentation - Status quo of ERNs and clinical research: results of the ERN-wide survey","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T14:02:00Z","last_updated_date":"2018-06-18T14:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-status-quo-erns-and-clinical-research-results-ern-wide-survey_en.pdf"},
    {"id":"2621","name":"Twenty-sixth meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-06-09T02:00:00Z","last_updated_date":"2000-06-09T02:00:00Z","reference_number":"EMEA/MB/025/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/twenty-sixth-meeting-management-board_en.pdf"},
    {"id":"2624","name":"CHMP summary of positive opinion for Levetiracetam Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/354114/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-levetiracetam-teva_en.pdf"},
    {"id":"2625","name":"Guideline on good pharmacovigilance practices: Introductory cover note, last updated with final new module on risk minimisation measures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T10:30:00Z","last_updated_date":"2014-02-28T10:30:00Z","reference_number":"EMA/61203/2014","document_url":"https://www.ema.europa.eu/en/documents/other/guideline-good-pharmacovigilance-practices-introductory-cover-note-last-updated-final-new-module-risk-minimisation-measures_en.pdf"},
    {"id":"2627","name":"Core SmSPC for Human Normal Immunoglobulin for Intravenous administration (IVIg) (CPMP/BPWG/859/95 rev.2)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-07-29T02:00:00Z","last_updated_date":"2004-07-29T02:00:00Z","reference_number":"CPMP/BPWG/859/95 rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/core-smspc-human-normal-immunoglobulin-intravenous-administration-ivig-cpmpbpwg85995-rev2_en.pdf"},
    {"id":"2630","name":"News bulletin for small and medium-sized enterprises - Issue 22","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2012-12-17T09:43:00Z","last_updated_date":"2012-12-17T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-22_en.pdf"},
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    {"id":"2634","name":"Day 80 assessment report overview guidance - generics rev.10.16","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-07-08T15:20:00Z","last_updated_date":"2016-11-08T12:05:00Z","reference_number":"Rev. 10.16","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-overview-guidance-generics-rev1016_en.pdf"},
    {"id":"2635","name":"Appendix 2: Agenda and participants - CAR-T cell therapy registries workshop","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-05-22T11:52:00Z","last_updated_date":"2018-05-22T11:52:00Z","reference_number":"EMA/299557/2018","document_url":"https://www.ema.europa.eu/en/documents/report/appendix-2-agenda-and-participants-car-t-cell-therapy-registries-workshop_en.pdf"},
    {"id":"2637","name":"EU/3/03/138: Public summary of positive opinion for orphan designation of α-1-acid glycoprotein for the treatment of tricyclic antidepressants poisoning","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-04-09T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/311/03 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303138-public-summary-positive-opinion-orphan-designation-i-1-acid-glycoprotein-treatment-tricyclic-antidepressants-poisoning_en.pdf"},
    {"id":"2642","name":"Presentation - 4.2 Evidence and decisions (Carl-Fredrik Burman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-42-evidence-and-decisions-carl-fredrik-burman_en.pdf"},
    {"id":"2643","name":"Presentation - Long-term PHARMacovigilance for adverse effects in childhood arthritis focusing on Immune modulatory drugs","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-22T01:00:00Z","last_updated_date":"2011-03-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-long-term-pharmacovigilance-adverse-effects-childhood-arthritis-focusing-immune-modulatory-drugs_en.pdf"},
    {"id":"2644","name":"EU/3/14/1355: Public summary of opinion on orphan designation: Selinexor for the treatment of plasma cell myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2021-06-07T09:47:00Z","reference_number":"EMA/COMP/637070/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141355-public-summary-opinion-orphan-designation-selinexor-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"2645","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zometa (zoledronic acid)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/831243/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zometa-zoledronic-acid_sv.pdf"}},
    {"id":"2646","name":"Letter of support for molecular imaging of the dopamine transporter biomarker as an enrichment biomarker for clinical trials for early Parkinson's disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T15:58:00Z","last_updated_date":"2016-10-07T15:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-molecular-imaging-dopamine-transporter-biomarker-enrichment-biomarker-clinical-trials-early-parkinsons-disease_en.pdf"},
    {"id":"2647","name":"Presentation - Current Issues in Biosimilar Regulatory Submission in US (S-C. Chow, FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-issues-biosimilar-regulatory-submission-us-s-c-chow-fda_en.pdf"},
    {"id":"2648","name":"Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Anoretics International Non-Proprietary Name (INN): Type II and Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1996-12-10T00:08:21Z","last_updated_date":"1996-12-10T00:08:21Z","reference_number":"CPMP/111-112/96","document_url":"https://www.ema.europa.eu/en/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-anoretics-international-non-proprietary-name-inn-type-ii-and-annex-i_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-anoretics-international-non-proprietary-name-inn-type-ii-and-annex-i_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-anoretics-international-non-proprietary-name-inn-type-ii-and-annex-i_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-anoretics-international-non-proprietary-name-inn-type-ii-and-annex-i_fr.pdf"}},
    {"id":"2649","name":"European Medicines Agency recommends interim measures for Pandemrix","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/CHMP/297822/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-interim-measures-pandemrix_en.pdf"},
    {"id":"2651","name":"Case Study: Ad2/HIF-1a/VP16: Experience with Viral Shedding & Circulation Testing - Ingrid Boltje","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/case-study-ad2hif-1avp16-experience-viral-shedding-circulation-testing-ingrid-boltje_en.pdf"},
    {"id":"2654","name":"Presentation - Revised immunogenicity guideline: assays and methods- presentation of the draft guideline and introduction of the topics for discussion (Robin Thorpe, Meenu Wadhwa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revised-immunogenicity-guideline-assays-and-methods-presentation-draft-guideline-and-introduction-topics-discussion-robin-thorpe-meenu-wadhwa_en.pdf"},
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    {"id":"2761","name":"Presentation - Better processes to facilitate earlier authorisation (Victoria Palmi, Sabrina Spinosa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-better-processes-facilitate-earlier-authorisation-victoria-palmi-sabrina-spinosa_en.pdf"},
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    {"id":"2763","name":"Committee for Orphan Medicinal Products: February 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-02-07T01:00:00Z","last_updated_date":"2005-02-07T01:00:00Z","reference_number":"EMEA/COMP/44905/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-february-2005-meeting_en.pdf"},
    {"id":"2764","name":"Overview of comments received on Community herbal monograph on Ononis spinosa L., radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2014-05-28T02:00:00Z","last_updated_date":"2014-05-28T02:00:00Z","reference_number":"EMA/HMPC/35010/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-ononis-spinosa-l-radix_en.pdf"},
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    {"id":"2773","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cyramza (ramucirumab) for the treatment of gastric cancer","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-01-30T01:00:00Z","last_updated_date":"2015-01-30T01:00:00Z","reference_number":"EMA/601520/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-cyramza-ramucirumab-treatment-gastric-cancer_en.pdf"},
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    {"id":"2779","name":"Presentation - EMA medical literature monitoring (MLM) service (Sabine Brosch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-medical-literature-monitoring-mlm-service-sabine-brosch_en.pdf"},
    {"id":"2780","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 9-11 April 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-12T19:00:00Z","last_updated_date":"2013-04-12T19:00:00Z","reference_number":"EMA/CVMP/200297/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-april-2013_en.pdf"},
    {"id":"2783","name":"EU/3/08/568: Public summary of positive opinion for orphan designation of N'-(5-chloro-2-hydroxy-3-methylbenzylidene)-2,4-dihydroxybenzhydrazide for the treatment of partial deep dermal and full thickness burn wounds","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2011-04-06T02:00:00Z","reference_number":"EMEA/COMP/456630/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308568-public-summary-positive-opinion-orphan-designation-n-5-chloro-2-hydroxy-3-methylbenzylidene-24-dihydroxybenzhydrazide-treatment-partial-deep-dermal-and-full-thickness-burn-wounds_en.pdf"},
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    {"id":"2787","name":"EU/3/17/1872: Public summary of opinion on orphan designation: Chimeric locked nucleic acid deoxynucleoside phosphorothioate-linked oligonucleotide inhibitor directed against microRNA-155-5p for the treatment of cutaneou...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-29T02:00:00Z","last_updated_date":"2022-06-22T14:45:00Z","reference_number":"EMA/274810/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171872-public-summary-opinion-orphan-designation-chimeric-locked-nucleic-acid-deoxynucleoside-phosphorothioate-linked-oligonucleotide-inhibitor-directed-against-microrna-155-5p-treatment-cutaneou_en.pdf"},
    {"id":"2788","name":"Pathogen-specific database: Anthrax","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-anthrax_en.pdf"},
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    {"id":"2791","name":"Agenda - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting factor concentrates (factor VIII and factor IX) with respect to pot...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-09-10T02:00:00Z","last_updated_date":"2013-09-10T02:00:00Z","reference_number":"EMA/439957/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-european-medicines-agency-european-directorate-quality-medicines-and-healthcare-workshop-characterisation-new-clotting-factor-concentrates-factor-viii-and-factor-ix-respect-pot_en.pdf"},
    {"id":"2792","name":"Key elements* for the summaries of product characteristics of the non-selective NSAIDs piroxicam, ketoprofen and ketorolac adopted by the CHMP","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-09-26T02:00:00Z","last_updated_date":"2006-09-26T02:00:00Z","reference_number":"EMEA/CHMP/381615/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/key-elements-summaries-product-characteristics-non-selective-nsaids-piroxicam-ketoprofen-and-ketorolac-adopted-chmp_en.pdf"},
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    {"id":"2832","name":"Assessment report for Antifibrinolytic medicines (aminocaproic acid)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-06T01:00:00Z","last_updated_date":"2013-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-antifibrinolytic-medicines-aminocaproic-acid_en.pdf"},
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    {"id":"2839","name":"Gardasil 9 offers wider protection against cancers caused by human papillomavirus (HPV)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T01:00:00Z","last_updated_date":"2015-03-27T01:00:00Z","reference_number":"EMA/CHMP/202995/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/gardasil-9-offers-wider-protection-against-cancers-caused-human-papillomavirus-hpv_en.pdf"},
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    {"id":"2845","name":"PDCO meeting dates for 2016, 2017 and 2018","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T12:45:00Z","last_updated_date":"2018-03-14T16:00:00Z","reference_number":"EMA/PDCO/393174/2016 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/pdco-meeting-dates-2016-2017-and-2018_en.pdf"},
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    {"id":"2849","name":"EU/3/12/1080 : Public summary of opinion on orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2018-11-22T12:00:00Z","reference_number":"EMA/COMP/720294/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121080-public-summary-opinion-orphan-designation-4-4-2-4-chlorophenyl-44-dimethylcyclohex-1-en-1-ylmethylpiperazin-1-yl-n-3-nitro-4-tetrahydro-2h-pyran-4-ylmethylaminophenylsulfonyl-2-1h_en.pdf"},
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    {"id":"2887","name":"Presentation - Topic 2 - International collaborations in pediatrics: FDA and EMA growing together - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Sandra L. Kweder)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-2-international-collaborations-pediatrics-fda-and-ema-growing-together-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-sandra-l-kweder_en.pdf"},
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    {"id":"2892","name":"EU/3/09/615: Public summary of positive opinion for orphan designation of N-terminal hexaglutamine-tagged recombinant human N-acetylgalactosamine-6-sulfate sulfatase for the treatment of mucopolysaccharidosis type IVA (M...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-30T00:00:00Z","last_updated_date":"2011-03-19T00:00:00Z","reference_number":"EMEA/COMP/118069/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309615-public-summary-positive-opinion-orphan-designation-n-terminal-hexaglutamine-tagged-recombinant-human-n-acetylgalactosamine-6-sulfate-sulfatase-treatment-mucopolysaccharidosis-type-iva-m_en.pdf"},
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    {"id":"2895","name":"Summary on compassionate use for Tamiflu IV","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-05-06T02:00:00Z","last_updated_date":"2013-08-30T17:52:00Z","reference_number":"EMA/CHMP/780707/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/summary-compassionate-use-tamiflu-iv_en.pdf"},
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    {"id":"2900","name":"EU/3/13/1134: Public summary of opinion on orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human ADA gene for the treatment of adenosine-deaminase-deficient severe combined i...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-06-25T19:00:00Z","reference_number":"EMA/COMP/277074/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131134-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-ada-gene-treatment-adenosine-deaminase-deficient-severe-combined-i_en.pdf"},
    {"id":"2902","name":"Erlotinib film-coated tablets 25, 100 and 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-04-10T02:00:00Z","last_updated_date":"2015-04-10T02:00:00Z","reference_number":"EMA/CHMP/675840/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/erlotinib-film-coated-tablets-25-100-and-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"2904","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the July 2008 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-07-11T02:09:21Z","last_updated_date":"2008-07-11T02:09:21Z","reference_number":"EMEA/COMP/363132/08","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-july-2008-meeting_en.pdf"},
    {"id":"2906","name":"Final European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-07-03T02:00:00Z","last_updated_date":"2018-07-03T02:00:00Z","reference_number":"EMA/HMPC/48745/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizome-revision-1_en.pdf"},
    {"id":"2907","name":"Javanese turmeric: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T01:00:00Z","last_updated_date":"2016-12-02T01:00:00Z","reference_number":"EMA/654803/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/javanese-turmeric-summary-public_en.pdf"},
    {"id":"2909","name":"CHMP post-authorisation summary of positive opinion for Retacrit","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/484149/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-retacrit_en.pdf"},
    {"id":"2910","name":"E 11: Clinical investigation of medicinal products in the paediatric population - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-01-01T01:00:00Z","last_updated_date":"2001-01-01T01:00:00Z","reference_number":"CPMP/ICH/2711/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/e-11-clinical-investigation-medicinal-products-paediatric-population-step-5_en.pdf"},
    {"id":"2912","name":"EMA concludes safety review of Uptravi","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-04-07T14:00:00Z","last_updated_date":"2017-04-07T14:00:00Z","reference_number":"EMA/224677/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-concludes-safety-review-uptravi_en.pdf"},
    {"id":"2913","name":"Zydelig Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"EMA/PRAC/197574/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-prac-list-questions_en.pdf"},
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    {"id":"2916","name":"Nomination of new Head of the Human Unit","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-07-25T02:00:00Z","last_updated_date":"2000-07-25T02:00:00Z","reference_number":"EMEA/D/20840/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/nomination-new-head-human-unit_en.pdf"},
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    {"id":"2934","name":"EU/3/09/613: Public summary of positive opinion for orphan designation of tobramycin (inhalation use) for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2018-02-09T01:00:00Z","reference_number":"EMEA/COMP/15451/2009 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309613-public-summary-positive-opinion-orphan-designation-tobramycin-inhalation-use-treatment-pseudomonas-aeruginosa-lung-infection-cystic-fibrosis_en.pdf"},
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    {"id":"2940","name":"Committee on herbal medicinal products (HMPC): Meeting report, 16 - 17 September 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-09-30T02:00:00Z","last_updated_date":"2009-09-30T02:00:00Z","reference_number":"EMEA/HMPC/611604/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-herbal-medicinal-products-hmpc-meeting-report-16-17-september-2009_en.pdf"},
    {"id":"2941","name":"New medicine for rare form of eye allergy in children and teenagers","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/CHMP/459946/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-rare-form-eye-allergy-children-and-teenagers_en.pdf"},
    {"id":"2943","name":"European Medicines Agency recommends extending use of Nexavar to include treatment of differentiated thyroid cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/242564/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-extending-use-nexavar-include-treatment-differentiated-thyroid-cancer_en.pdf"},
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    {"id":"2949","name":"Thiocolchicoside Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-03-06T01:00:00Z","last_updated_date":"2014-03-06T01:00:00Z","reference_number":"EMA/40340/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-assessment-report_en.pdf"},
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    {"id":"2952","name":"EU/3/09/679: Public summary of positive opinion for orphan designation of 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-11-18T00:09:21Z","last_updated_date":"2013-10-18T01:09:21Z","reference_number":"EMEA/COMP/591799/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309679-public-summary-positive-opinion-orphan-designation-4-benzyl-2-naphtalen-1-yl-124-thiadiazolidine-35-dione-treatment-progressive-supranuclear-palsy_en.pdf"},
    {"id":"2954","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-06-21T17:21:00Z","last_updated_date":"2017-06-21T17:21:00Z","reference_number":"EMA/288176/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-spinraza-nusinersen-treatment-5q-spinal-muscular-atrophy_en.pdf"},
    {"id":"2955","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cresemba (isavuconazole) for the treatment of invasive aspergillosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-11-05T15:52:00Z","last_updated_date":"2015-11-05T15:52:00Z","reference_number":"EMA/582962/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-cresemba-isavuconazole-treatment-invasive-aspergillosis_en.pdf"},
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    {"id":"2959","name":"Agenda for the 83rd meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2014-03-14T16:20:00Z","last_updated_date":"2014-03-25T13:30:00Z","reference_number":"EMA/MB/2712/2014 Version 4","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-83rd-meeting-management-board_en.pdf"},
    {"id":"2961","name":"EU/3/16/1616: Public summary of opinion on orphan designation: Diclofenamide for the treatment of periodic paralysis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/61828/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161616-public-summary-opinion-orphan-designation-diclofenamide-treatment-periodic-paralysis_en.pdf"},
    {"id":"2962","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 16-19 January 2012","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/CHMP/SAWP/50093/2012","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-16-19-january-2012_en.pdf"},
    {"id":"2963","name":"Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 13-15 April 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-04-16T02:00:00Z","last_updated_date":"2010-04-16T02:00:00Z","reference_number":"EMA/CVMP/212502/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-april-2010_en.pdf"},
    {"id":"2965","name":"Sanofi Aventis withdraws its marketing authorisation application for Sliwens","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-21T01:00:00Z","last_updated_date":"2009-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/sanofi-aventis-withdraws-its-marketing-authorisation-application-sliwens_en.pdf"},
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    {"id":"2968","name":"EU/3/14/1350: Public summary of opinion on orphan designation: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor for the treatment of tenosynovial giant cell...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/553659/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141350-public-summary-opinion-orphan-designation-recombinant-human-monoclonal-antibody-igg1-kappa-class-against-human-macrophage-colony-stimulating-factor-treatment-tenosynovial-giant-cell_en.pdf"},
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    {"id":"2971","name":"Draft list of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-07-23T02:00:00Z","last_updated_date":"2015-07-23T02:00:00Z","reference_number":"EMA/HMPC/150847/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-valeriana-officinalis-l-radix-and-valeriana-officinalis-l-aetheroleum_en.pdf"},
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    {"id":"2978","name":"Public statement on Xigris: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-02-21T15:23:00Z","last_updated_date":"2012-02-21T15:23:00Z","reference_number":"EMA/128419/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-xigris-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"2979","name":"EU/3/14/1271: Public summary of opinion on orphan designation of 177Lu-tetraxetan-tetulomab for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/239252/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141271-public-summary-opinion-orphan-designation-177lu-tetraxetan-tetulomab-treatment-follicular-lymphoma_en.pdf"},
    {"id":"2981","name":"Guidance on format of the risk-management plan in the European Union part II: Module SVIII - Summary of the safety concerns","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2013-08-21T18:35:00Z","reference_number":"EMA/465928/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-sviii-summary-safety-concerns_en.pdf"},
    {"id":"2984","name":"Rapinyl - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-09-25T02:08:21Z","last_updated_date":"2009-09-25T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/rapinyl-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"2985","name":"Presentation - Supply shortages of medicines in Europe (Francois Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supply-shortages-medicines-europe-francois-houyez_en.pdf"},
    {"id":"2988","name":"Overview of comments received on Community herbal monograph on Levisticum officinale Koch, radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2013-02-22T16:00:00Z","last_updated_date":"2013-02-22T16:00:00Z","reference_number":"EMEA/HMPC/411398/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-levisticum-officinale-koch-radix_en.pdf"},
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    {"id":"2990","name":"European Medicines Agency recommends first switch from prescription-only to non-prescription for a centrally authorised medicine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-23T02:09:21Z","last_updated_date":"2008-10-23T02:09:21Z","reference_number":"EMEA/CHMP/493770/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-first-switch-prescription-only-non-prescription-centrally-authorised-medicine_en.pdf"},
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    {"id":"2996","name":"Draft list of references for assessment of: Polypodii rhizoma Polypodium vulgare L., rhizoma (polypody rhizome)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-05-08T02:00:00Z","last_updated_date":"2008-05-08T02:00:00Z","reference_number":"EMEA/HMPC/600670/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-polypodii-rhizoma-polypodium-vulgare-l-rhizoma-polypody-rhizome_en.pdf"},
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    {"id":"3003","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 19-22 January 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-02-02T16:30:00Z","last_updated_date":"2015-02-02T16:30:00Z","reference_number":"EMA/38511/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-19-22-january-2015_en.pdf"},
    {"id":"3004","name":"Lux Biosciences GmbH withdraws its marketing authorisation application for Luveniq (voclosporin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/833913/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/lux-biosciences-gmbh-withdraws-its-marketing-authorisation-application-luveniq-voclosporin_en.pdf"},
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    {"id":"3006","name":"What's new in pharmacovigilance - QPPV Update - Issue 3 - 2017","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2017-12-21T12:00:00Z","last_updated_date":"2017-12-21T12:00:00Z","reference_number":"Issue 3 - 2017","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-3-2017_en.pdf"},
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    {"id":"3017","name":"Overview of Regulation of Stem Cell-based products by the USA FDA: Dr Kimberly Benton, Division of Cellular and Gene Therapies, Office for Cellular, Tissue and Gene Therapy, CBER, FDA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-regulation-stem-cell-based-products-usa-fda-dr-kimberly-benton-division-cellular-and-gene-therapies-office-cellular-tissue-and-gene-therapy-cber-fda_en.pdf"},
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    {"id":"3025","name":"Outcomes of the workshop - Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-06-03T14:00:00Z","last_updated_date":"2016-06-03T14:00:00Z","reference_number":"EMA/345874/2016","document_url":"https://www.ema.europa.eu/en/documents/report/outcomes-workshop-multi-stakeholder-advanced-therapy-medicinal-products-atmps-expert-meeting-exploring-solutions-foster-atmps-development-and-patient-access-europe_en.pdf"},
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    {"id":"3038","name":"EU/3/06/364: Public summary of positive opinion for orphan designation of sorafenib tosylate for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2018-01-31T13:30:00Z","reference_number":"EMEA/COMP/95269/2006 Rev3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306364-public-summary-positive-opinion-orphan-designation-sorafenib-tosylate-treatment-hepatocellular-carcinoma_en.pdf"},
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    {"id":"3046","name":"Public statement on Rasilamlo (aliskiren / amlodipine): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-03-21T10:42:00Z","last_updated_date":"2017-03-21T10:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-rasilamlo-aliskiren-amlodipine-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"3049","name":"Overview of comments received on draft guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T00:00:00Z","last_updated_date":"2008-11-20T00:00:00Z","reference_number":"EMEA/477055/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-guideline-safety-and-efficacy-follow-risk-management-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"3050","name":"Overview of comments received on 'Guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health (OIE) requirements'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-11-19T12:00:00Z","last_updated_date":"2014-11-19T12:00:00Z","reference_number":"EMA/CVMP/IWP/36240/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-compliance-authorised-equine-influenza-vaccines-world-organisation-animal-health-oie-requirements_en.pdf"},
    {"id":"3051","name":"Famotidine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001350/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-12T13:49:00Z","last_updated_date":"2018-07-12T13:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/famotidine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001350201709_sv.pdf"}},
    {"id":"3055","name":"Guideline on dossier requirements for anticancer medicinal products for dogs and cats","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-20T02:00:00Z","last_updated_date":"2009-04-20T02:00:00Z","reference_number":"EMEA/CVMP/28510/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-dossier-requirements-anticancer-medicinal-products-dogs-and-cats_en.pdf"},
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    {"id":"3057","name":"CVMP summary of positive opinion for Veraflox","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-07-16T02:00:00Z","last_updated_date":"2011-02-11T01:00:00Z","reference_number":"EMA/CVMP/411755/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-veraflox_en.pdf"},
    {"id":"3058","name":"Presentation - Treatment of chronic hepatitis C virus infection in children and adolescents: Guidance for clinical trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-12T03:00:00Z","last_updated_date":"2011-07-12T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-treatment-chronic-hepatitis-c-virus-infection-children-and-adolescents-guidance-clinical-trials_en.pdf"},
    {"id":"3059","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Athens)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T12:57:00Z","last_updated_date":"2017-06-15T16:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-athens_en.pdf"},
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    {"id":"3063","name":"CHMP post-authorisation summary of positive opinion for Harvoni","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"EMA/384974/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-harvoni_en.pdf"},
    {"id":"3067","name":"Pharmacovigilance Risk Assessment Committee (PRAC) work plan 2015","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2015-07-07T13:05:00Z","last_updated_date":"2015-07-07T13:05:00Z","reference_number":"EMA/PRAC/794108/2013","document_url":"https://www.ema.europa.eu/en/documents/work-programme/pharmacovigilance-risk-assessment-committee-prac-work-plan-2015_en.pdf"},
    {"id":"3068","name":"Results of the sampling and testing programme for the year 2011","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-10-17T12:25:00Z","last_updated_date":"2012-10-17T12:25:00Z","reference_number":"EMA/INS/S&T/579345/2012","document_url":"https://www.ema.europa.eu/en/documents/report/results-sampling-and-testing-programme-year-2011_en.pdf"},
    {"id":"3069","name":"European Medicines Agency launches consultation on its Road Map to 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-26T01:00:00Z","last_updated_date":"2010-01-26T01:00:00Z","reference_number":"EMA/54050/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-consultation-its-road-map-2015_en.pdf"},
    {"id":"3070","name":"Guideline on influenza vaccines – Quality module","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-06-02T16:00:00Z","last_updated_date":"2014-06-02T16:00:00Z","reference_number":"EMA/CHMP/BWP/310834/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-influenza-vaccines-quality-module_en.pdf"},
    {"id":"3072","name":"EU/3/01/030: Public summary of positive opinion for orphan designation\n\nof 8-cyclopentyl-1,3-dipropylxanthine for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/22868/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301030-public-summary-positive-opinion-orphan-designation-8-cyclopentyl-13-dipropylxanthine-treatment-cystic-fibrosis_en.pdf"},
    {"id":"3073","name":"Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the European Economic Area","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-11-18T13:00:00Z","last_updated_date":"2016-11-18T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-icsrs-european-economic-area_en.pdf"},
    {"id":"3075","name":"Tazocin - Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tazocin-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tazocin-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tazocin-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tazocin-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tazocin-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tazocin-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tazocin-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tazocin-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tazocin-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tazocin-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tazocin-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tazocin-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tazocin-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tazocin-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tazocin-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tazocin-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tazocin-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tazocin-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tazocin-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tazocin-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tazocin-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tazocin-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/tazocin-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/tazocin-article-30-referral-annex-iii_no.pdf"}},
    {"id":"3077","name":"Presentation - Sub population: the elderly - How can modelling and simulation inform understanding of safety and efficacy? (Amy S. Y. Cheung)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sub-population-elderly-how-can-modelling-and-simulation-inform-understanding-safety-and-efficacy-amy-s-y-cheung_en.pdf"},
    {"id":"3081","name":"Assessment report for Antifibrinolytic medicines (tranexamic acid)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-06T01:00:00Z","last_updated_date":"2013-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-antifibrinolytic-medicines-tranexamic-acid_en.pdf"},
    {"id":"3083","name":"Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T13:00:01Z","last_updated_date":"2018-03-09T13:00:01Z","reference_number":"EMA/76828/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/women-taking-esmya-uterine-fibroids-have-regular-liver-tests-while-ema-review-ongoing_en.pdf"},
    {"id":"3084","name":"Points to consider on clinical investigation of medicinal products other than nsaids for treatment of rheumatoid arthritis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-12-17T01:00:00Z","last_updated_date":"2003-12-17T01:00:00Z","reference_number":"CPMP/EWP/556/95 rev 1/Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-clinical-investigation-medicinal-products-other-nsaids-treatment-rheumatoid-arthritis_en.pdf"},
    {"id":"3085","name":"Scientific recommendation on classification of advanced therapy medicinal products: Living, autologous, melanoma-derived lymphocytes (CD3+)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T19:00:00Z","last_updated_date":"2015-08-26T19:00:00Z","reference_number":"EMA/555336/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-living-autologous-melanoma-derived-lymphocytes-cd3_en.pdf"},
    {"id":"3086","name":"Overview of comments received on ' Guideline on Clinical Investigation of Medicinal Products in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-22T12:00:00Z","last_updated_date":"2012-11-22T12:00:00Z","reference_number":"EMA/CHMP/700490/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-chronic-obstructive-pulmonary-disease-copd_en.pdf"},
    {"id":"3087","name":"Guidelines and concept papers adopted at the CHMP meeting 22-25 April 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T17:40:00Z","last_updated_date":"2014-04-29T17:40:00Z","reference_number":"EMA/124006/2014","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-chmp-meeting-22-25-april-2014_en.pdf"},
    {"id":"3088","name":"CHMP post-authorisation summary of positive opinion for Sprycel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/CHMP/646979/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sprycel_en.pdf"},
    {"id":"3089","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline M7 (R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals ...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-07-27T12:54:00Z","last_updated_date":"2017-07-27T12:54:00Z","reference_number":"EMA/CHMP/ICH/83812/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-guideline-m7-r1-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals_en.pdf"},
    {"id":"3090","name":"Efpia info day 2000 minus 2 - performance indicators of the Centralised Procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"1998-11-20T00:00:00Z","last_updated_date":"1998-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/efpia-info-day-2000-minus-2-performance-indicators-centralised-procedure_en.pdf"},
    {"id":"3091","name":"Overview of comments received on European Union herbal monograph on Matricaria recutita L., aetheroleum - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-05T02:00:00Z","last_updated_date":"2016-04-05T02:00:00Z","reference_number":"EMA/HMPC/706537/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-matricaria-recutita-l-aetheroleum-first-version_en.pdf"},
    {"id":"3092","name":"Presentation - PIP session: Overview of paediatric investigation plans for uveitis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pip-session-overview-paediatric-investigation-plans-uveitis_en.pdf"},
    {"id":"3093","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final module VII revision 1 on PSURs and considerations I on vaccines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-12T11:00:00Z","last_updated_date":"2013-12-12T11:00:00Z","reference_number":"EMA/757334/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-final-module-vii-revision-1-psurs-and-considerations-i-vaccines_en.pdf"},
    {"id":"3100","name":"Agenda - EudraVigilance Training in 2006, A joint initiative of the EMEA with DIA acting as the conference organiser","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-04-07T02:09:21Z","last_updated_date":"2006-04-07T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eudravigilance-training-2006-joint-initiative-emea-dia-acting-conference-organiser_en.pdf"},
    {"id":"3102","name":"Presentation - 10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP): Patients and Consumers: a 360o view (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-10th-anniversary-european-medicines-agencys-patients-and-consumers-working-party-pcwp-patients-and-consumers-360o-view-nathalie-bere_en.pdf"},
    {"id":"3104","name":"Presentation - Regulatory evaluation and perspectives on dose-exposure-response information in new drug applications (Naoyuki Yabana, Naomi Nagai)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-evaluation-and-perspectives-dose-exposure-response-information-new-drug-applications-naoyuki-yabana-naomi-nagai_en.pdf"},
    {"id":"3107","name":"Coumafos: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-01-01T01:00:00Z","last_updated_date":"2001-01-01T01:00:00Z","reference_number":"EMEA/MRL69/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/coumafos-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"3108","name":"EU/3/15/1553: Public summary of opinion on orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of primary mediastinal l...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-16T01:00:00Z","last_updated_date":"2015-11-16T01:00:00Z","reference_number":"EMA/COMP/597518/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151553-public-summary-opinion-orphan-designation-autologous-t-cells-transduced-retroviral-vector-encoding-anti-cd19-cd28cd3-zeta-chimeric-antigen-receptor-treatment-primary-mediastinal-l_en.pdf"},
    {"id":"3109","name":"Agenda for the 77th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2012-10-10T14:00:00Z","last_updated_date":"2012-10-10T14:00:00Z","reference_number":"EMA/MB/397583/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-77th-meeting-management-board_en.pdf"},
    {"id":"3110","name":"Draft EMEA pandemic influenza crisis management plan for the evaluation and maintenance of pandemic influenza vaccines and antivirals","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-11-14T00:09:21Z","last_updated_date":"2005-11-14T00:09:21Z","reference_number":"EMEA/397403/2005","document_url":"https://www.ema.europa.eu/en/documents/other/draft-emea-pandemic-influenza-crisis-management-plan-evaluation-and-maintenance-pandemic-influenza-vaccines-and-antivirals_en.pdf"},
    {"id":"3111","name":"Tetrazepam-containing medicines - Article-107i procedure - Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-29T02:00:00Z","last_updated_date":"2013-04-29T02:00:00Z","reference_number":"EMA/256383/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-recommendation-suspend-tetrazepam-containing-medicines-endorsed-cmdh_en.pdf"},
    {"id":"3112","name":"Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Endpoints (Health Canada)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emafdahealth-canada-workshop-paediatric-pulmonary-arterial-hypertension-endpoints-health-canada_en.pdf"},
    {"id":"3113","name":"Guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-10-21T02:00:00Z","last_updated_date":"2004-10-21T02:00:00Z","reference_number":"CPMP/BWP/CPMP/5136/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-manufacturing-processes-plasma-derived-medicinal-products-regard-variant-creutzfeldt-jakob-disease-risk_en.pdf"},
    {"id":"3114","name":"Presentation - Potential of GI outcome measures in CFTR modulation (Frank Bodewes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-26T01:00:00Z","last_updated_date":"2016-01-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-potential-gi-outcome-measures-cftr-modulation-frank-bodewes_en.pdf"},
    {"id":"3116","name":"Overview of comments received on 'position paper on potential medication errors in the context of benefit-risk balance and risk-minimisation measures'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T16:55:00Z","last_updated_date":"2013-06-07T16:55:00Z","reference_number":"EMA/CHMP/277592/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-position-paper-potential-medication-errors-context-benefit-risk-balance-and-risk-minimisation-measures_en.pdf"},
    {"id":"3119","name":"Concept paper on the need to revise the note for guidance on requirements for combined vaccines CVMP/IWP/52/97-FINAL","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-01-16T01:00:00Z","last_updated_date":"2004-01-16T01:00:00Z","reference_number":"EMEA/CVMP/018/04-CONS.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-note-guidance-requirements-combined-vaccines-cvmpiwp5297-final_en.pdf"},
    {"id":"3120","name":"Guideline on the principles for preparing assessment reports for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T10:00:00Z","last_updated_date":"2015-12-18T10:00:00Z","reference_number":"EMA/CVMP/450781/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-principles-preparing-assessment-reports-veterinary-medicinal-products_en.pdf"},
    {"id":"3121","name":"Presentation - Pharmacovigilance information systems and services (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-information-systems-and-services-peter-arlett_en.pdf"},
    {"id":"3123","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 15-18 October 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T13:40:00Z","last_updated_date":"2012-10-25T13:40:00Z","reference_number":"EMA/CHMP/539797/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-during-chmp-meeting-15-18-october-2012_en.pdf"},
    {"id":"3124","name":"Public consultation on new EMEA transparency initiatives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2000-02-28T01:00:00Z","last_updated_date":"2000-02-28T01:00:00Z","reference_number":"EMEA/D/6135/00","document_url":"https://www.ema.europa.eu/en/documents/other/public-consultation-new-emea-transparency-initiatives_en.pdf"},
    {"id":"3125","name":"Presentation - Facilitating engagement with the FDA to allow shaping paediatric development programmes (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T18:21:00Z","last_updated_date":"2017-05-12T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-facilitating-engagement-fda-allow-shaping-paediatric-development-programmes-irmgard-eichler_en.pdf"},
    {"id":"3126","name":"HPV vaccines - Article-20 procedure - Review concludes evidence does not support that HPV vaccines cause CRPS or POTS","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-11-05T01:00:00Z","last_updated_date":"2015-11-05T01:00:00Z","reference_number":"EMA/714950/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/hpv-vaccines-article-20-procedure-review-concludes-evidence-does-not-support-hpv-vaccines-cause-crps-or-pots_en.pdf"},
    {"id":"3127","name":"Presentation - Workshop on patient’s voice in the evaluation of medicines - The impatient patient - From anger to activism (EATG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T01:00:00Z","last_updated_date":"2013-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patients-voice-evaluation-medicines-impatient-patient-anger-activism-eatg_en.pdf"},
    {"id":"3128","name":"Opinion of the CVMP on the establishment of maximum residue limits: Derquantel","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CVMP/261782/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-derquantel_en.pdf"},
    {"id":"3129","name":"EU/3/12/951: Public summary of opinion on orphan designation: Sodium phenylbutyrate for the treatment of carbamoyl-phosphate-synthase-1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2017-08-09T02:00:00Z","reference_number":"EMA/COMP/43230/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312951-public-summary-opinion-orphan-designation-sodium-phenylbutyrate-treatment-carbamoyl-phosphate-synthase-1_en.pdf"},
    {"id":"3130","name":"EU/3/08/601: Public summary of positive opinion for orphan designation of milatuzumab for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/609983/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308601-public-summary-positive-opinion-orphan-designation-milatuzumab-treatment-multiple-myeloma_en.pdf"},
    {"id":"3132","name":"Questions and answers on the withdrawal of the marketing authorisation application for Aripiprazole Mylan (aripiprazole)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-01-29T01:00:00Z","reference_number":"EMA/55039/2016","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-aripiprazole-mylan-aripiprazole_sv.pdf"}},
    {"id":"3135","name":"Questions and answers on the review of Preflucel and associated names (influenza vaccine, purified antigen)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-07-20T17:02:16Z","last_updated_date":"2012-07-20T17:02:16Z","reference_number":"EMEA/H/A-36/1323","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-preflucel-and-associated-names-influenza-vaccine-purified-antigen_en.pdf"},
    {"id":"3136","name":"News bulletin for small and medium-sized enterprises - Issue 32","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-07-30T10:40:00Z","last_updated_date":"2015-07-30T10:40:00Z","reference_number":"Issue 32","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-32_en.pdf"},
    {"id":"3137","name":"CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Draft advice version 1.0 – including comments received on this version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-advice-european-medicines-agency-clinical-trial-advisory-group-rules-engagement-draft-advice-version-10-including-comments-received-version_en.pdf"},
    {"id":"3139","name":"CHMP summary of positive opinion for Libertek","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2018-02-08T01:00:00Z","reference_number":"EMA/CHMP/775689/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-libertek_en.pdf"},
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    {"id":"3147","name":"EU/3/00/005: Public summary of positive opinion for orphan designation of gemtuzumab ozogamicin for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-11-08T00:00:00Z","last_updated_date":"2013-06-19T14:00:00Z","reference_number":"EMEA/COMP/375/04 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300005-public-summary-positive-opinion-orphan-designation-gemtuzumab-ozogamicin-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"3149","name":"Renewal of the Cooperation Agreement between the National Competent Authorities and the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-26T14:10:00Z","last_updated_date":"2015-03-26T14:10:00Z","reference_number":"EMA/MB/99041/2015","document_url":"https://www.ema.europa.eu/en/documents/other/renewal-cooperation-agreement-between-national-competent-authorities-and-european-medicines-agency_en.pdf"},
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    {"id":"3152","name":"EU/3/07/490: Public summary of positive opinion for orphan designation of human autologous bone-forming cells derived from bone marrow stem cells for treatment of non-traumatic osteonecrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-01-17T01:00:00Z","last_updated_date":"2008-01-17T01:00:00Z","reference_number":"EMEA/COMP/440983/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307490-public-summary-positive-opinion-orphan-designation-human-autologous-bone-forming-cells-derived-bone-marrow-stem-cells-treatment-non-traumatic-osteonecrosis_en.pdf"},
    {"id":"3153","name":"Presentation - The PRIME scheme experience 1 year on (Jordi Llinares Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prime-scheme-experience-1-year-jordi-llinares-garcia_en.pdf"},
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    {"id":"3158","name":"Questions and answers on the review of Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names (goserelin, 3.6 mg implant)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"EMA/CHMP/477156/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-novosis-goserelin-goserelin-cell-pharm-novimp-and-associated-names-goserelin-36-mg-implant_sv.pdf"}},
    {"id":"3160","name":"Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-04T02:00:00Z","last_updated_date":"2016-10-04T02:00:00Z","reference_number":"EMA/283107/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/trimetazidine-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsr0001-and-emeahnpsrj0002_en.pdf"},
    {"id":"3161","name":"CHMP post-authorisation summary of positive opinion for Stelara","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/CHMP/435265/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stelara_en.pdf"},
    {"id":"3162","name":"Committee for Medicinal Products for Human Use (CHMP) - December 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-12-23T01:00:00Z","last_updated_date":"2003-12-23T01:00:00Z","reference_number":"EMEA/CPMP/6016/03","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-december-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"3165","name":"CHMP post-authorisation summary of positive opinion for Sprycel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-04-27T14:00:00Z","last_updated_date":"2018-04-27T14:00:00Z","reference_number":"EMA/CHMP/243108/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sprycel_en.pdf-0"},
    {"id":"3166","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 17-19 June 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-07-01T12:50:00Z","last_updated_date":"2015-07-01T12:50:00Z","reference_number":"EMA/411248/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-17-19-june-2015_en.pdf"},
    {"id":"3167","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 16-17 September 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-10-10T16:40:00Z","last_updated_date":"2013-10-10T16:40:00Z","reference_number":"EMA/HMPC/587804/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-16-17-september-2013_en.pdf"},
    {"id":"3168","name":"Committee on Medicinal Products for Veterinary Use strategy on antimicrobials 2006-2010 and status report on activities on antimicrobials","type":"report","status":"unknown","consultation_date":"","first_published_date":"2006-03-20T01:00:00Z","last_updated_date":"2006-03-20T01:00:00Z","reference_number":"EMEA/CVMP/353297/2005","document_url":"https://www.ema.europa.eu/en/documents/report/committee-medicinal-products-veterinary-use-strategy-antimicrobials-2006-2010-and-status-report-activities-antimicrobials_en.pdf"},
    {"id":"3169","name":"Letter of invitation to tender - EMA/2012/01/A-FI-AC for banking services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-21T11:51:00Z","last_updated_date":"2012-06-21T11:51:00Z","reference_number":"EMA/388284/2012","document_url":"https://www.ema.europa.eu/en/documents/other/letter-invitation-tender-ema201201a-fi-ac-banking-services_en.pdf"},
    {"id":"3173","name":"Agenda - Eighth stakeholders forum on the implementation of the pharmacovigilance legislation: Building on two years of operation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-10T16:00:00Z","last_updated_date":"2014-09-10T16:00:00Z","reference_number":"EMA/449800/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eighth-stakeholders-forum-implementation-pharmacovigilance-legislation-building-two-years-operation_en.pdf"},
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    {"id":"3229","name":"Questions and answers on the withdrawal of the marketing authorisation application for Bosatria (mepolizumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-08-20T02:00:00Z","last_updated_date":"2009-08-20T02:00:00Z","reference_number":"EMEA/505188/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-bosatria-mepolizumab_sv.pdf"}},
    {"id":"3230","name":"Presentation - International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E7 requirements and how they are translated in practice","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-e7-requirements-and-how-they-are-translated-practice_en.pdf"},
    {"id":"3231","name":"Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-12T17:52:00Z","last_updated_date":"2017-12-12T17:54:19Z","reference_number":"EMA/776067/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/fenspiride-list-nationally-authorised-medicinal-products-psusa00001368201704_en.pdf"},
    {"id":"3235","name":"Presentation - 3.3 Training for patients' and consumers' organisations - Frequently asked questions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T12:00:00Z","last_updated_date":"2011-11-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-33-training-patients-and-consumers-organisations-frequently-asked-questions_en.pdf"},
    {"id":"3241","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Osamu Doi","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-osamu-doi_en.pdf"},
    {"id":"3242","name":"CVMP summary of negative opinion for Horse Allo 20","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T18:00:00Z","last_updated_date":"2018-06-22T18:00:00Z","reference_number":"EMA/CVMP/371385/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-negative-opinion-horse-allo-20_en.pdf"},
    {"id":"3244","name":"CHMP post-authorisation summary of positive opinion for Edarbi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/569644/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-edarbi_en.pdf"},
    {"id":"3245","name":"Conference announcement - 10 years of the Orphan Regulation in Europe","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-04T01:00:00Z","last_updated_date":"2010-02-04T01:00:00Z","reference_number":"EMA/815144/2009","document_url":"https://www.ema.europa.eu/en/documents/other/conference-announcement-10-years-orphan-regulation-europe_en.pdf"},
    {"id":"3246","name":"Zinnat - Article-30 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T14:00:00Z","last_updated_date":"2013-01-29T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinnat-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinnat-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinnat-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinnat-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinnat-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinnat-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinnat-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinnat-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinnat-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinnat-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinnat-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinnat-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinnat-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinnat-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinnat-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinnat-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinnat-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinnat-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinnat-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinnat-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinnat-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinnat-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/zinnat-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/zinnat-article-30-referral-annex-iii_no.pdf"}},
    {"id":"3247","name":"Committee for Orphan Medicinal Products: November 2003 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-11-07T01:00:00Z","last_updated_date":"2003-11-07T01:00:00Z","reference_number":"EMEA/COMP/1552/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-november-2003-meeting_en.pdf"},
    {"id":"3248","name":"EU/3/17/1942: Public summary of opinion on orphan designation: N-(2-aminophenyl)-4-(1-[(1,3-dimethyl-1H-pyrazol-4-yl)methyl]piperidin)benzamide for the treatment of peripheral T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/694349/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171942-public-summary-opinion-orphan-designation-n-2-aminophenyl-4-1-13-dimethyl-1h-pyrazol-4-ylmethylpiperidinbenzamide-treatment-peripheral-t-cell-lymphoma_en.pdf"},
    {"id":"3250","name":"Directive amending for traditional herbal medicinal products, Directive 2001/83/EC - Giuseppe Nistico","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-09-27T02:09:21Z","last_updated_date":"2004-09-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/directive-amending-traditional-herbal-medicinal-products-directive-200183ec-giuseppe-nistico_en.pdf"},
    {"id":"3252","name":"Presentation - PML London Clinical Researchers perspective, Igor Koralnik","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pml-london-clinical-researchers-perspective-igor-koralnik_en.pdf"},
    {"id":"3253","name":"Presentation - EMBL-EBI resources and groups (Andrew Leach)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-embl-ebi-resources-and-groups-andrew-leach_en.pdf"},
    {"id":"3254","name":"Guideline on the environmental risk assessment of medicinal products for human use - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2015-01-13T10:00:00Z","reference_number":"EMEA/CHMP/SWP/4447/00 Corr 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf"},
    {"id":"3257","name":"EU/3/13/1209: Public summary of opinion on orphan designation: Nitric oxide for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2014-01-23T01:00:00Z","reference_number":"EMA/COMP/710260/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131209-public-summary-opinion-orphan-designation-nitric-oxide-treatment-cystic-fibrosis_en.pdf"},
    {"id":"3259","name":"Benserazide / levodopa: List of nationally authorised medicinal products - PSUSA/00000330/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T17:00:00Z","last_updated_date":"2018-02-09T17:00:00Z","reference_number":"EMA/88406/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/benserazide-levodopa-list-nationally-authorised-medicinal-products-psusa00000330201706_en.pdf"},
    {"id":"3260","name":"Neomycin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"EMEA/MRL/730/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/neomycin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"3261","name":"Letter of support to explore clinical outcomes assessments utility to measure clinical symptoms in people with autism spectrum disorders (ASD)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T12:00:00Z","last_updated_date":"2015-12-09T12:00:00Z","reference_number":"EMA/794457/2015","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-explore-clinical-outcomes-assessments-utility-measure-clinical-symptoms-people-autism-spectrum-disorders-asd_en.pdf"},
    {"id":"3263","name":"Presentation - Involvement of patients' and consumers' organisations and healthcare professionals in safety communications (Nathalie Bere, Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-24T18:30:00Z","last_updated_date":"2013-05-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involvement-patients-and-consumers-organisations-and-healthcare-professionals-safety-communications-nathalie-bere-ivana-silva_en.pdf"},
    {"id":"3266","name":"Presentation - Control of veterinary drug residue in European Union","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-control-veterinary-drug-residue-european-union_en.pdf"},
    {"id":"3267","name":"Committee for medicinal products for veterinary use: Meeting of 13-15 January 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-01-16T00:09:21Z","last_updated_date":"2009-01-16T00:09:21Z","reference_number":"EMEA/CVMP/2934/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-13-15-january-2009_en.pdf"},
    {"id":"3270","name":"Opinion of HMPC on a Community herbal monograph on Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T01:00:00Z","last_updated_date":"2013-03-04T01:00:00Z","reference_number":"EMA/HMPC/332113/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"3271","name":"Presentation - GMP Inspection in Serbia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gmp-inspection-serbia_en.pdf"},
    {"id":"3272","name":"Valproate Article-31 referral - Timetable","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T01:00:00Z","last_updated_date":"2017-12-07T01:00:00Z","reference_number":"EMA/PRAC/154221/2017 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-timetable_en.pdf"},
    {"id":"3273","name":"EU/3/09/698: Public summary of positive opinion for orphan designation of\n\npegylated carboxyhaemoglobin for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-12-08T00:09:21Z","last_updated_date":"2009-12-08T00:09:21Z","reference_number":"EMA/COMP/654109/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309698-public-summary-positive-opinion-orphan-designation-pegylated-carboxyhaemoglobin-treatment-sickle-cell-disease_en.pdf"},
    {"id":"3275","name":"Opinions on safety variations / periodic safety update reports adopted at the CHMP meeting 22-25 July 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T17:00:00Z","last_updated_date":"2013-08-21T17:00:00Z","reference_number":"EMA/CHMP/241121/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-periodic-safety-update-reports-adopted-chmp-meeting-22-25-july-2013_en.pdf"},
    {"id":"3276","name":"CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 1 summary overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-meeting-1-summary-overview_en.pdf"},
    {"id":"3278","name":"EU/3/18/1996: Public summary of opinion on orphan designation: Melatonin for the treatment of neonatal encephalopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-15T02:00:00Z","last_updated_date":"2018-05-15T02:00:00Z","reference_number":"EMA/141281/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181996-public-summary-opinion-orphan-designation-melatonin-treatment-neonatal-encephalopathy_en.pdf"},
    {"id":"3280","name":"CHMP post-authorisation summary of positive opinion for Eylea","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/284732/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-eylea_en.pdf"},
    {"id":"3281","name":"Committee for Medicinal Products for Human Use (CHMP) - February 2011 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-02-25T01:00:00Z","last_updated_date":"2011-02-25T01:00:00Z","reference_number":"EMA/CHMP/14522/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-february-2011-plenary-meeting-monthly-report_en.pdf"},
    {"id":"3283","name":"Standard operating procedure for consultation of environmental competent authorities on genetically modified organisms with respect to environmental risk assessment in product evaluation (human use)","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2009-10-07T02:00:00Z","last_updated_date":"2020-01-22T12:30:00Z","reference_number":"SOP/H/3191","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-consultation-environmental-competent-authorities-genetically-modified-organisms-respect-environmental-risk-assessment-product-evaluation-human-use_en.pdf"},
    {"id":"3284","name":"Agenda - PRAC draft agenda of meeting 5-8 February 2018","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-02-05T17:34:00Z","last_updated_date":"2018-02-05T17:34:00Z","reference_number":"EMA/PRAC/73812/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-5-8-february-2018_en.pdf"},
    {"id":"3286","name":"Presentation - Overview of the Paediatric Rheumatology Expert Meeting","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-paediatric-rheumatology-expert-meeting_en.pdf"},
    {"id":"3287","name":"CHMP summary of positive opinion for Mepact","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/668423/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mepact_en.pdf"},
    {"id":"3289","name":"Presentation - Setting health-based exposure limits for highly hazardous products to ensure patient safety – application of the Q&A (R. Frà¶tschl, BfArm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-setting-health-based-exposure-limits-highly-hazardous-products-ensure-patient-safety-application-qa-r-fraptschl-bfarm_en.pdf"},
    {"id":"3290","name":"Committee for Medicinal Products for Human Use (CHMP) - January 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-01-30T01:00:00Z","last_updated_date":"2003-01-30T01:00:00Z","reference_number":"EMEA/CPMP/209/03","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-january-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"3292","name":"Questions and answers on Priorix (measles, mumps and rubella vaccine (live))","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-06-21T13:01:00Z","reference_number":"EMA/CHMP/178705/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-priorix-measles-mumps-and-rubella-vaccine-live_sv.pdf"}},
    {"id":"3293","name":"Presentation - Delivering the benefits of the new PSUR for healthcare professionals and patients – efficient and effective implementation An Industry perspective (Klaudija Marijanovic Barac)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-delivering-benefits-new-psur-healthcare-professionals-and-patients-efficient-and-effective-implementation-industry-perspective-klaudija-marijanovic-barac_en.pdf"},
    {"id":"3296","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the seventieth meeting of the committee for veterinary medicinal products took place in London on 9-10 October 2001.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-10-11T14:59:21Z","last_updated_date":"2001-10-11T14:59:21Z","reference_number":"EMEA/CVMP/911/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-seventieth-meeting-committee-veterinary-medicinal-products-took-place-london-9-10-october-2001_en.pdf"},
    {"id":"3297","name":"Declaration of interests - Paolo Rossi","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-paolo-rossi_en.pdf"},
    {"id":"3301","name":"Assessment report on Polypodium vulgare L., rhizoma","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/600669/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/assessment-report-polypodium-vulgare-l-rhizoma_en.pdf"},
    {"id":"3302","name":"Withdrawal letter: Erbitux (cetuximab)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-12T02:00:00Z","last_updated_date":"2012-10-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-erbitux-cetuximab_en.pdf"},
    {"id":"3303","name":"CHMP summary of positive opinion for Lonquex","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T14:00:00Z","last_updated_date":"2013-05-31T14:00:00Z","reference_number":"EMA/CHMP/274489/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lonquex_en.pdf"},
    {"id":"3305","name":"Presentation - 10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP): PCWP 10 years (David Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-10th-anniversary-european-medicines-agencys-patients-and-consumers-working-party-pcwp-pcwp-10-years-david-haerry_en.pdf"},
    {"id":"3306","name":"Draft community herbal monograph on Polypodium vulgare L., rhizoma","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-08T02:00:00Z","last_updated_date":"2008-05-08T02:00:00Z","reference_number":"EMEA/HMPC/600668/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-polypodium-vulgare-l-rhizoma_en.pdf"},
    {"id":"3308","name":"Declaration of interests - David Coghill","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-david-coghill_en.pdf"},
    {"id":"3309","name":"Presentation - Translating regulatory science into better processes (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-translating-regulatory-science-better-processes-xavier-kurz_en.pdf"},
    {"id":"3310","name":"CVMP post-authorisation summary of positive opinion for Convenia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-12-11T01:09:21Z","last_updated_date":"2009-12-11T01:09:21Z","reference_number":"EMA/CVMP/734100/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-convenia_en.pdf"},
    {"id":"3311","name":"Report on the experts' round table on the difficulties related to the use of new medicinal products in children held 18 December 1997","type":"report","status":"unknown","consultation_date":"","first_published_date":"1998-07-30T02:00:00Z","last_updated_date":"2010-02-11T21:21:54Z","reference_number":"EMEA/27164/98 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/report-experts-round-table-difficulties-related-use-new-medicinal-products-children-held-18-december-1997_en.pdf"},
    {"id":"3313","name":"CHMP post-authorisation summary of positive opinion for Prolia (II-68)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-04-27T14:00:00Z","last_updated_date":"2018-04-27T14:00:00Z","reference_number":"EMA/CHMP/256922/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prolia-ii-68_en.pdf"},
    {"id":"3315","name":"Organisational matters: adopted at the CHMP meeting 18-21 November 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-11-27T12:25:00Z","last_updated_date":"2013-11-27T12:25:00Z","reference_number":"EMA/710477/2013","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-adopted-chmp-meeting-18-21-november-2013_en.pdf"},
    {"id":"3317","name":"Overview of comments received on draft guideline on ankylosing spondylitis (CPMP/EWP/4891/03) - First version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/EWP/537007/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-ankylosing-spondylitis-cpmpewp489103-first-version_en.pdf"},
    {"id":"3318","name":"Draft list of references supporting the assessment of Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium and fructus – Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2017-10-12T02:00:00Z","last_updated_date":"2017-10-12T02:00:00Z","reference_number":"EMA/HMPC/228760/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-senna-alexandrina-mill-cassia-senna-l-cassia-angustifolia-vahl-folium-and-fructus-revision-1_en.pdf"},
    {"id":"3319","name":"Trimetazidine - Article 31 - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-17T02:00:00Z","last_updated_date":"2012-10-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/trimetazidine-article-31-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/trimetazidine-article-31-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/trimetazidine-article-31-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/trimetazidine-article-31-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/trimetazidine-article-31-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/trimetazidine-article-31-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/trimetazidine-article-31-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/trimetazidine-article-31-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/trimetazidine-article-31-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/trimetazidine-article-31-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/trimetazidine-article-31-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/trimetazidine-article-31-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/trimetazidine-article-31-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/trimetazidine-article-31-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/trimetazidine-article-31-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/trimetazidine-article-31-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/trimetazidine-article-31-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/trimetazidine-article-31-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/trimetazidine-article-31-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/trimetazidine-article-31-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/trimetazidine-article-31-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/trimetazidine-article-31-annex-iii_sv.pdf"}},
    {"id":"3320","name":"Presentation - IRDiRC: EU Research funding for rare disease research (Irene Norstedt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-irdirc-eu-research-funding-rare-disease-research-irene-norstedt_en.pdf"},
    {"id":"3322","name":"CHMP post-authorisation summary of positive opinion for Humira on 24 July 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-07-28T02:00:00Z","last_updated_date":"2008-07-28T02:00:00Z","reference_number":"EMEA/CHMP/384125/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira-24-july-2008_en.pdf"},
    {"id":"3323","name":"EU/3/02/102: Public summary of positive opinion for orphan designation of mitotane for the treatment of adrenal cortical carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T01:00:00Z","last_updated_date":"2014-06-19T02:00:00Z","reference_number":"EMEA/COMP/966/02 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302102-public-summary-positive-opinion-orphan-designation-mitotane-treatment-adrenal-cortical-carcinoma_en.pdf"},
    {"id":"3326","name":"Agenda - PRAC draft agenda of meeting 14-17 March 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-03-14T20:00:00Z","last_updated_date":"2016-03-14T20:00:00Z","reference_number":"EMA/PRAC/199507/2016 Corr.","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-14-17-march-2016_en.pdf"},
    {"id":"3327","name":"CHMP summary of positive opinion for Imprida HCT","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/471451/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imprida-hct_en.pdf"},
    {"id":"3328","name":"Draft guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-05-24T02:00:00Z","last_updated_date":"2007-05-24T02:00:00Z","reference_number":"CHMP/EWP/18504/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-products-specific-immunotherapy-treatment-allergic-diseases_en.pdf"},
    {"id":"3330","name":"Presentation - COMP's perspective: Regulatory challenges and opportunities - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines (Bru...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comps-perspective-regulatory-challenges-and-opportunities-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"3332","name":"Questions and answers on the recommendation to withdraw the marketing authorisations for lumiracoxib-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2007-12-13T01:00:00Z","last_updated_date":"2007-12-13T01:00:00Z","reference_number":"EMEA/536363/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-recommendation-withdraw-marketing-authorisations-lumiracoxib-containing-medicines_en.pdf"},
    {"id":"3333","name":"EU/3/15/1603: Public summary of opinion on orphan designation: Live attenuated Listeria monocytogenes delta actA/delta inlB strain expressing human mesothelin for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T01:00:00Z","reference_number":"EMA/COMP/848213/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151603-public-summary-opinion-orphan-designation-live-attenuated-listeria-monocytogenes-delta-actadelta-inlb-strain-expressing-human-mesothelin-treatment-pancreatic-cancer_en.pdf"},
    {"id":"3334","name":"Draft guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"CPMP/EWP/784/97 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-used-treatment-osteoarthritis_en.pdf"},
    {"id":"3335","name":"Final assessment report on Eucalyptus globulus Labill., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-04-19T12:00:00Z","last_updated_date":"2013-04-19T12:00:00Z","reference_number":"EMA/HMPC/892615/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-eucalyptus-globulus-labill-folium_en.pdf"},
    {"id":"3336","name":"Kristian Svendsen (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/kristian-svendsen-cv_en.pdf"},
    {"id":"3337","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Vimizim (elosulfase alfa) for the treatment of mucopolysaccharidosis, type IVA (Morquio A syndrome)","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-06-26T02:00:00Z","last_updated_date":"2014-06-26T02:00:00Z","reference_number":"EMA/COMP/139514/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-vimizim-elosulfase-alfa-treatment-mucopolysaccharidosis-type-iva-morquio-syndrome_en.pdf"},
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    {"id":"3346","name":"Mycophenolic acid (apart from mycophenolate mofetil): List of nationally authorised medicinal products - PSUSA/00010243/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-12T10:05:00Z","last_updated_date":"2016-12-12T10:08:00Z","reference_number":"EMA/848467/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/mycophenolic-acid-apart-mycophenolate-mofetil-list-nationally-authorised-medicinal-products-psusa00010243201605_en.pdf"},
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    {"id":"3351","name":"Retinoid Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-08-04T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-annex-i_en.pdf"},
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    {"id":"3354","name":"Recommendation on the submission of multistrain-dossier applications for vaccines against avian influenza, bluetongue and foot-and-mouth disease","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-03-18T01:00:00Z","last_updated_date":"2010-03-18T01:00:00Z","reference_number":"EMA/43283/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-submission-multistrain-dossier-applications-vaccines-against-avian-influenza-bluetongue-and-foot-and-mouth-disease_en.pdf"},
    {"id":"3355","name":"Tadalafil film-coated tablets 2.5, 5, 10 and 20 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/315234/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/tadalafil-film-coated-tablets-25-5-10-and-20-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"3356","name":"Final European Union herbal monograph on Echinacea pallida (Nutt.) Nutt., radix - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-08-14T12:00:00Z","last_updated_date":"2018-08-14T12:00:00Z","reference_number":"EMA/HMPC/737380/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-echinacea-pallida-nutt-nutt-radix-revision-1_en.pdf"},
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    {"id":"3362","name":"Paricalcitol: List of nationally authorised medicinal products - PSUSA/00002316/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-04-10T19:15:00Z","last_updated_date":"2017-04-10T19:15:00Z","reference_number":"EMA/236467/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/paricalcitol-list-nationally-authorised-medicinal-products-psusa00002316201608_en.pdf"},
    {"id":"3367","name":"Principal documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2022-02-18T13:35:00Z","reference_number":"EMA/30963/2022","document_url":"https://www.ema.europa.eu/en/documents/other/principal-documents-taken-account-preparation-procedures-gcp-inspections-requested-chmp_en.pdf"},
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    {"id":"3373","name":"Diplomatic Notes exchanged on completion of the preparatory work 28 April 2004: European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-04-28T02:00:00Z","last_updated_date":"2004-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/diplomatic-notes-exchanged-completion-preparatory-work-28-april-2004-european-commission_en.pdf"},
    {"id":"3374","name":"Agenda - PRAC draft agenda of meeting 9-12 April 2018","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-04-09T17:44:00Z","last_updated_date":"2018-04-09T17:44:00Z","reference_number":"EMA/223357/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-9-12-april-2018_en.pdf"},
    {"id":"3375","name":"CHMP post-authorisation summary of positive opinion for Synflorix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/497733/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-synflorix_en.pdf"},
    {"id":"3378","name":"Bladderwrack: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T17:31:00Z","last_updated_date":"2016-12-02T17:31:00Z","reference_number":"EMA/661584/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/bladderwrack-summary-public_en.pdf"},
    {"id":"3379","name":"Position paper regarding availability of veterinary medicinal products - extrapolation of maximum residue limits","type":"position","status":"Adopted","consultation_date":"","first_published_date":"2003-12-10T01:00:00Z","last_updated_date":"2003-12-10T01:00:00Z","reference_number":"EMEA/CVMP/457/03","document_url":"https://www.ema.europa.eu/en/documents/position/position-paper-regarding-availability-veterinary-medicinal-products-extrapolation-maximum-residue-limits_en.pdf"},
    {"id":"3380","name":"Quinolone and fluoroquinolone Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-02-13T01:00:00Z","last_updated_date":"2019-03-19T11:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/quinolone-and-fluoroquinolone-article-31-referral-annex-i_no.pdf"}},
    {"id":"3381","name":"PDCO meeting report 7-9 September 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-09-16T11:21:00Z","last_updated_date":"2011-09-16T11:21:00Z","reference_number":"EMA/PDCO/725936/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-7-9-september-2011_en.pdf"},
    {"id":"3383","name":"Annex VIII - List of cilostazol-containing medicinal products in the European Union","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2014-05-28T11:15:00Z","last_updated_date":"2017-07-26T13:30:00Z","reference_number":"EMA/294357/2014 correction 2*","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-viii-list-cilostazol-containing-medicinal-products-european-union_en.pdf"},
    {"id":"3384","name":"Presentation - Perspective of EPL and PM regarding interactions with applicants (Pavel Balabanov, Leonor Enes, Viktor Vlcek)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T02:00:00Z","last_updated_date":"2015-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-perspective-epl-and-pm-regarding-interactions-applicants-pavel-balabanov-leonor-enes-viktor-vlcek_en.pdf"},
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    {"id":"3436","name":"Procedure for the preparation of a risk-based programme for routine pharmacovigilance inspections of MAHs connected with human Centrally Authorized Products (CAPs)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-20T02:00:00Z","last_updated_date":"2014-06-20T02:00:00Z","reference_number":"EMEA/INS/PhV/105504/2008 Superseded","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-preparation-risk-based-programme-routine-pharmacovigilance-inspections-mahs-connected-human-centrally-authorized-products-caps_en.pdf"},
    {"id":"3439","name":"EMA Management Board: highlights of March 2018 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-03-16T10:15:00Z","last_updated_date":"2018-03-16T10:15:00Z","reference_number":"EMA/162881/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-march-2018-meeting_en.pdf"},
    {"id":"3442","name":"Recommendation on the need for revision of (CHMP) points to consider on the requirements for clinical documentation for Orally Inhaled Products (OIP) (CPMP/EWP/4151/00)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-02-22T01:00:00Z","last_updated_date":"2007-02-22T01:00:00Z","reference_number":"EMEA/CHMP/EWP/44238/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-need-revision-chmp-points-consider-requirements-clinical-documentation-orally-inhaled-products-oip-cpmpewp415100_en.pdf"},
    {"id":"3444","name":"Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-05-19T02:00:00Z","reference_number":"EMA/34577/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-rocephin-and-associated-names-ceftriaxone-250-mg-500-mg-1-g-2-g-powder-solution-injection-or-infusion_sv.pdf"}},
    {"id":"3448","name":"Opinion following an Article 7(5) referral for Laurina and related invented names International Non-Proprietary Name (INN): Desogestrel/ethinlestradiol: Background information and Annexes I, II (English) and Annex III (a...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-02-02T00:08:21Z","last_updated_date":"2004-02-02T00:08:21Z","reference_number":"CPMP/1390/04","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-75-referral-laurina-and-related-invented-names-international-non-proprietary-name-inn-desogestrelethinlestradiol-background-information-and-annexes-i-ii-english-and-annex-iii_sv.pdf"}},
    {"id":"3449","name":"Presentation - Involving patients and healthcare professionals - MHRA(Janine Jolly)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involving-patients-and-healthcare-professionals-mhrajanine-jolly_en.pdf"},
    {"id":"3452","name":"Reinforcing patient safety in Europe - Flyer","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-27T02:00:00Z","last_updated_date":"2011-04-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/reinforcing-patient-safety-europe-flyer_en.pdf"},
    {"id":"3453","name":"Gendux Molecular Limited withdraws its marketing authorisation application for Advexin (contusugene ladenovec)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"EMEA/690558/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/gendux-molecular-limited-withdraws-its-marketing-authorisation-application-advexin-contusugene-ladenovec_en.pdf"},
    {"id":"3455","name":"Opinion following an Article 33(4)  referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"MA/539462/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_sv.pdf"}},
    {"id":"3456","name":"EU/3/16/1643: Public summary of opinion on orphan designation: Autologous stromal vascular cell fraction from adipose tissue for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-31T02:00:00Z","last_updated_date":"2020-08-13T02:00:00Z","reference_number":"EMA/COMP/236625/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161643-public-summary-opinion-orphan-designation-autologous-stromal-vascular-cell-fraction-adipose-tissue-treatment-systemic-sclerosis_en.pdf"},
    {"id":"3457","name":"Presentation - Update on public hearing (J.Garcia Burgos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T02:00:00Z","last_updated_date":"2017-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-public-hearing-jgarcia-burgos-ema_en.pdf"},
    {"id":"3458","name":"Superseded list of references supporting the assessment of Centella asiatica (L.) Urban, herba","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2022-09-02T17:50:00Z","last_updated_date":"2022-09-02T17:50:00Z","reference_number":"EMA/HMPC/291180/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-centella-asiatica-l-urban-herba_en.pdf"},
    {"id":"3459","name":"Public statement on Tenecteplase Boehringer Ingelheim Pharma GmbH & co. KG (tenecteplase): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-12-05T12:49:21Z","last_updated_date":"2005-12-05T12:49:21Z","reference_number":"CHMP/343408/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-tenecteplase-boehringer-ingelheim-pharma-gmbh-co-kg-tenecteplase-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"3460","name":"CHMP summary of positive opinion for Temozolomide Sandoz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/810097/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-temozolomide-sandoz_en.pdf"},
    {"id":"3461","name":"Opinions on safety variations / periodic safety update reports adopted at the CHMP meeting of 24-27 June 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-08T02:00:00Z","last_updated_date":"2013-07-09T19:30:00Z","reference_number":"EMA/CHMP/240801/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-periodic-safety-update-reports-adopted-chmp-meeting-24-27-june-2013_en.pdf"},
    {"id":"3463","name":"Statement of authority and confidentiality commitment from the United States Food and drug Administration (FDA) not publicly disclose non-public information shared by the European Commission's Directorate-General for Hea...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-23T12:00:00Z","last_updated_date":"2017-08-23T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/statement-authority-and-confidentiality-commitment-united-states-food-and-drug-administration-fda-not-publicly-disclose-non-public-information-shared-european-commissions-directorate-general-hea_en.pdf"},
    {"id":"3464","name":"EMEA recommends a new warning for epoetins for their use in cancer patients","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2008-06-26T02:09:21Z","reference_number":"EMEA/CHMP/333963/2008 –corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-new-warning-epoetins-their-use-cancer-patients_en.pdf"},
    {"id":"3465","name":"Presentation - Marketing Authorisation Issues for SMEs (Anna-Maria Brady)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-marketing-authorisation-issues-smes-anna-maria-brady_en.pdf"},
    {"id":"3468","name":"Daunorubicin: List of nationally authorised medicinal products - PSUSA/00000936/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-04T14:00:00Z","last_updated_date":"2016-10-17T20:25:31Z","reference_number":"EMA/238885/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/daunorubicin-list-nationally-authorised-medicinal-products-psusa00000936201506_en.pdf"},
    {"id":"3469","name":"Ex ante publicity of a negotiated procedure: EMA/2017/12/COM – Financial information on companies and legal entities","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2017-04-11T10:44:00Z","last_updated_date":"2017-04-11T10:44:00Z","reference_number":"EMA/215198/2017","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201712com-financial-information-companies-and-legal-entities_en.pdf"},
    {"id":"3470","name":"Public Statement on Positive Opinion for Tuberculosis Vaccine","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2006-11-29T00:09:21Z","last_updated_date":"2006-11-29T00:09:21Z","reference_number":"EMEA/71122/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-positive-opinion-tuberculosis-vaccine_en.pdf"},
    {"id":"3471","name":"Substances used in homeopathic veterinary medicines:  European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-21T01:00:00Z","last_updated_date":"2013-11-21T01:00:00Z","reference_number":"EMEA/CVMP/016/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/substances-used-homeopathic-veterinary-medicines-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
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    {"id":"3476","name":"Standard operating procedure for preparation of question-and-answer documents for withdrawals of marketing authorisation applications by the Medical Information Sector","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-11-28T01:00:00Z","last_updated_date":"2012-03-22T11:00:00Z","reference_number":"SOP/H/3137","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-question-and-answer-documents-withdrawals-marketing-authorisation-applications-medical-information-sector_en.pdf"},
    {"id":"3478","name":"European Medicines Agency report on the implementation of the possibility for waiving the target animal batch safety test for immunological veterinary medicinal products in the European Union","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-01-23T11:15:00Z","last_updated_date":"2012-01-23T11:15:00Z","reference_number":"EMA/675371/2011","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-report-implementation-possibility-waiving-target-animal-batch-safety-test-immunological-veterinary-medicinal-products-european-union_en.pdf"},
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    {"id":"3480","name":"Agenda - EMA workshop on the collaboration with general practitioners / family physicians","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-04-18T12:00:00Z","last_updated_date":"2016-04-28T12:00:00Z","reference_number":"EMA/40570/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-workshop-collaboration-general-practitioners-family-physicians_en.pdf"},
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    {"id":"3482","name":"Committee for medicinal products for veterinary use: Meeting of 13-15 October 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-10-16T02:09:21Z","last_updated_date":"2009-10-16T02:09:21Z","reference_number":"EMEA/CVMP/627024/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-13-15-october-2009_en.pdf"},
    {"id":"3483","name":"Presentation - Case study 2 - Development and verification of design space","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-2-development-and-verification-design-space_en.pdf"},
    {"id":"3484","name":"CHMP summary of positive opinion for Nimvastid","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-03-19T01:00:00Z","last_updated_date":"2009-03-19T01:00:00Z","reference_number":"EMEA/CHMP/153867/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nimvastid_en.pdf"},
    {"id":"3487","name":"Presentation - Key concepts of orphan designation and latest developments (Jordi Llinares)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-concepts-orphan-designation-and-latest-developments-jordi-llinares_en.pdf"},
    {"id":"3488","name":"Standard Operating Procedure for translation workflow of EMA documents","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2010-10-25T02:00:00Z","last_updated_date":"2010-10-25T02:00:00Z","reference_number":"SOP/PDM/1400","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-translation-workflow-ema-documents_en.pdf"},
    {"id":"3490","name":"Overview of comments received on guideline on non-clinical documentation for herbal medicinal products in applications for autorisation (bibliographical and mixed applications) and in applications for simplified registra...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-07-13T02:00:00Z","last_updated_date":"2006-07-13T02:00:00Z","reference_number":"EMEA/HMPC/132154/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-non-clinical-documentation-herbal-medicinal-products-applications-autorisation-bibliographical-and-mixed-applications-and-applications-simplified-registra_en.pdf"},
    {"id":"3491","name":"Annual report of the Good Clinical Practice Inspections Working Group 2014","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T16:35:00Z","last_updated_date":"2015-07-03T16:35:00Z","reference_number":"EMA/INS/GCP/434373/2014","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-good-clinical-practice-inspections-working-group-2014_en.pdf"},
    {"id":"3492","name":"Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2018-03-16T17:30:00Z","last_updated_date":"2018-03-16T17:30:00Z","reference_number":"EMA/PRAC/139104/2018","document_url":"https://www.ema.europa.eu/en/documents/work-programme/pharmacovigilance-risk-assessment-committee-prac-work-plan-2018_en.pdf"},
    {"id":"3493","name":"Committee for medicinal products for veterinary use summary of opinion: Aivlosin 42.5 mg/g oral powder for pigs: International Non-proprietary Names (INN): Tylvalosin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-10-16T03:09:21Z","last_updated_date":"2009-10-16T03:09:21Z","reference_number":"EMEA/CVMP/632577/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/committee-medicinal-products-veterinary-use-summary-opinion-aivlosin-425-mgg-oral-powder-pigs-international-non-proprietary-names-inn-tylvalosin_en.pdf"},
    {"id":"3494","name":"Renewal of the mandate for the Joint Expert Group on 3Rs (replacement, reduction, refinement)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/95290/2013","document_url":"https://www.ema.europa.eu/en/documents/other/renewal-mandate-joint-expert-group-3rs-replacement-reduction-refinement_en.pdf"},
    {"id":"3495","name":"EU/3/07/507: Public summary of positive opinion for orphan designation of doxorubicin hydrochloride (drug eluting beads) for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"EMEA/COMP/489044/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307507-public-summary-positive-opinion-orphan-designation-doxorubicin-hydrochloride-drug-eluting-beads-treatment-glioma_en.pdf"},
    {"id":"3498","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Brineura (cerliponase alfa) for the treatment of neuronal ceroid lipofuscinosis","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-06-22T16:29:00Z","last_updated_date":"2017-06-22T16:29:00Z","reference_number":"EMA/291639/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-brineura-cerliponase-alfa-treatment-neuronal-ceroid-lipofuscinosis_en.pdf"},
    {"id":"3500","name":"EU/3/07/464: Public summary of positive opinion for orphan designation of panobinostat lactate for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-01-22T00:00:00Z","last_updated_date":"2015-02-11T16:00:00Z","reference_number":"EMA/COMP/286087/2007 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307464-public-summary-positive-opinion-orphan-designation-panobinostat-lactate-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"3501","name":"EU/3/11/928: Public summary of opinion on orphan designation: Cysteamine for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/COMP/870559/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311928-public-summary-opinion-orphan-designation-cysteamine-treatment-cystic-fibrosis_en.pdf"},
    {"id":"3502","name":"Technical specifications - Annex IV - Draft concession agreement - Procurement procedure EMA/2014/35/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T15:00:00Z","last_updated_date":"2015-02-23T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-iv-draft-concession-agreement-procurement-procedure-ema201435re_en.pdf"},
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    {"id":"3506","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Emtricitabine / Propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin- 9-yl)propan-2-yl]-oxy}methyl)(phenoxy) phosphoryl]-Lalaninate, (2E)-but-2-ened...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/793626/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-emtricitabine-propan-2-yl-n-s-2r-1-6-amino-9h-purin-9-ylpropan-2-yl-oxymethylphenoxy-phosphoryl-lalaninate-2e-2-ened_en.pdf"},
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    {"id":"3509","name":"Questions and answers on Solamocta 697 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys (amoxicillin trihydrate)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T01:00:00Z","reference_number":"EMA/23095/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-solamocta-697-mgg-powder-use-drinking-water-chickens-ducks-and-turkeys-amoxicillin-trihydrate_sv.pdf"}},
    {"id":"3510","name":"Agenda - Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: identifying solutions for big data challenges","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-04-27T13:10:00Z","last_updated_date":"2018-05-02T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-heads-medicines-agencies-hma-european-medicines-agency-ema-joint-big-data-task-force-meeting-identifying-solutions-big-data-challenges_en.pdf"},
    {"id":"3511","name":"Agenda - Programme and registration form for: Global animal health conference: Global availability of veterinary medicines - providing a climate for science and innovation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-11-17T01:00:00Z","last_updated_date":"2011-03-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-and-registration-form-global-animal-health-conference-global-availability-veterinary-medicines-providing-climate-science-and-innovation_en.pdf"},
    {"id":"3512","name":"Administrative information Application form for a Scientific Opinion according to Article 58 of Regulation (EC) 726/2004","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2009-04-01T02:00:00Z","last_updated_date":"2017-09-04T02:00:00Z","reference_number":"EMEA/210134/2008","document_url":"https://www.ema.europa.eu/en/documents/template-form/administrative-information-application-form-scientific-opinion-according-article-58-regulation-ec-7262004_en.doc"},
    {"id":"3513","name":"CVMP post-authorisation summary of positive opinion for Metacam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-02-13T01:00:00Z","last_updated_date":"2015-02-13T01:00:00Z","reference_number":"EMA/CVMP/736376/2014 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam_en.pdf"},
    {"id":"3515","name":"Calcium carbonate / famotidine / magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001351/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2016-10-18T15:41:07Z","reference_number":"EMA/540919/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-carbonate-famotidine-magnesium-hydroxide-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001351201409_en.pdf"},
    {"id":"3516","name":"The Food and Environment Research Agency (FERA), National Bee Unit, Selwyn Wilkins, FERA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/food-and-environment-research-agency-fera-national-bee-unit-selwyn-wilkins-fera_en.pdf"},
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    {"id":"3518","name":"European Commission-Japan mutual recognition agreement: Sectoral annex on good manufacturing practice for medicinal products - Fourth sub-committee meeting, 26 and 27 October 2006: Joint common statement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:00:00Z","last_updated_date":"2006-10-27T02:00:00Z","reference_number":"EMEA/INS/MRA/446188/2006","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-japan-mutual-recognition-agreement-sectoral-annex-good-manufacturing-practice-medicinal-products-fourth-sub-committee-meeting-26-and-27-october-2006-joint-common-statement_en.pdf"},
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    {"id":"3531","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 18 -21 April 2005","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-04-21T02:00:00Z","last_updated_date":"2005-04-21T02:00:00Z","reference_number":"EMEA/138444/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-18-21-april-2005_en.pdf"},
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    {"id":"3569","name":"Adeno-associated virus serotype 2 based vector containing the human RPE65 gene expression cassette","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2016-05-04T13:00:00Z","reference_number":"EMA/291899/2016","document_url":"https://www.ema.europa.eu/en/documents/report/adeno-associated-virus-serotype-2-based-vector-containing-human-rpe65-gene-expression-cassette_en.pdf"},
    {"id":"3570","name":"Presentation - SPOR communication and training update (Gabriel Boronat, Agnieszka Laka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T17:00:00Z","last_updated_date":"2017-12-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spor-communication-and-training-update-gabriel-boronat-agnieszka-laka_en.pdf"},
    {"id":"3572","name":"Position paper on the regulatory requirements for the authorisation of low-dose modified release asa formulations in the secondary prevention of cardiovascular events","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-07-25T02:00:00Z","last_updated_date":"2002-07-25T02:00:00Z","reference_number":"EMEA/CPMP/EWP/282/02/Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-regulatory-requirements-authorisation-low-dose-modified-release-asa-formulations-secondary-prevention-cardiovascular-events_en.pdf"},
    {"id":"3574","name":"EU/3/15/1448: Public summary of opinion on orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild type human histidyl-tRNA synthetase for the treatment of facioscapulohumeral muscular ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2015-04-09T02:00:00Z","reference_number":"EMA/COMP/31818/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151448-public-summary-opinion-orphan-designation-505-amino-acid-protein-corresponding-amino-acids-2-506-wild-type-human-histidyl-trna-synthetase-treatment-facioscapulohumeral-muscular_en.pdf"},
    {"id":"3575","name":"EU/3/15/1476: Public summary of positive opinion for orphan designation of 1-(4-(N-glycylamido)phenyl)-3-trifluoromethyl-5-(phenanthren-2-yl)-pyrazole-hydrochloride for the treatment of tularaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-21T14:00:00Z","last_updated_date":"2015-05-21T14:00:00Z","reference_number":"EMA/COMP/211415/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151476-public-summary-positive-opinion-orphan-designation-1-4-n-glycylamidophenyl-3-trifluoromethyl-5-phenanthren-2-yl-pyrazole-hydrochloride-treatment-tularaemia_en.pdf"},
    {"id":"3577","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - July 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-08-03T02:00:00Z","last_updated_date":"2010-08-03T02:00:00Z","reference_number":"EMA/CVMP/450079/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-july-2010_en.pdf"},
    {"id":"3578","name":"2nd meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-05-16T02:00:00Z","last_updated_date":"2000-05-16T02:00:00Z","reference_number":"EMEA/COMP/9/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/2nd-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"3580","name":"CHMP summary of positive opinion for Revinty Ellipta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/CHMP/137719/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-revinty-ellipta_en.pdf"},
    {"id":"3582","name":"Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-05T12:10:00Z","last_updated_date":"2017-10-05T12:10:00Z","reference_number":"EMA/658413/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-coagulation-factor-viii-inhibitor-bypassing-fraction-list-nationally-authorised-medicinal-products-psusa00009174201702_en.pdf"},
    {"id":"3583","name":"Experience from an SME in initiating clinical trials, Dr Tom Vanthienen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/experience-sme-initiating-clinical-trials-dr-tom-vanthienen_en.pdf"},
    {"id":"3585","name":"Work instructions for handling of paediatric Article 45 work-sharing procedures by the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human (CMDh) secretariat","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2014-03-21T16:30:00Z","reference_number":"WIN/H/3374","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-handling-paediatric-article-45-work-sharing-procedures-co-ordination-group-mutual-recognition-and-decentralised-procedure-human-cmdh-secretariat_en.pdf"},
    {"id":"3586","name":"COMP meeting report on the review of applications for orphan designation: December 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-01-13T15:15:00Z","last_updated_date":"2014-01-13T15:15:00Z","reference_number":"EMA/COMP/699713/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-december-2013_en.pdf"},
    {"id":"3589","name":"Writing an assessment report - Malcolm Dash","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/writing-assessment-report-malcolm-dash_en.pdf"},
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    {"id":"3596","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 19-22 April 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"EMA/CHMP/110267/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-19-22-april-2010_en.pdf"},
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    {"id":"3599","name":"Position paper on terminology in pharmacoGenetics","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-11-21T01:00:00Z","last_updated_date":"2002-11-21T01:00:00Z","reference_number":"EMEA/CPMP/3070/01 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-terminology-pharmacogenetics_en.pdf"},
    {"id":"3600","name":"Gadoxetic acid disodium: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001509/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-10-18T16:56:38Z","reference_number":"EMA/200892/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoxetic-acid-disodium-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001509201504_en.pdf"},
    {"id":"3602","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel Qualimed","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2014-09-08T02:00:00Z","reference_number":"EMEA/CHMP/379506/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-qualimed_en.pdf"},
    {"id":"3604","name":"Sandimmun Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-12-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sandimmun-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sandimmun-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sandimmun-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sandimmun-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sandimmun-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sandimmun-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sandimmun-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sandimmun-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sandimmun-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sandimmun-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sandimmun-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sandimmun-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sandimmun-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sandimmun-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sandimmun-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sandimmun-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sandimmun-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sandimmun-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sandimmun-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sandimmun-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sandimmun-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sandimmun-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sandimmun-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/sandimmun-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/sandimmun-article-30-referral-annex-iii_no.pdf"}},
    {"id":"3605","name":"Received Comments to the Draft Guideline (Rev1) for treatment of Alzheimer's disease and other dementias - Susanna Del Signore","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-11T00:09:21Z","last_updated_date":"2008-02-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/received-comments-draft-guideline-rev1-treatment-alzheimers-disease-and-other-dementias-susanna-del-signore_en.pdf"},
    {"id":"3606","name":"Presentation - FDA approaches to analytical challenges posed by big data (David Martin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-approaches-analytical-challenges-posed-big-data-david-martin_en.pdf"},
    {"id":"3607","name":"Final assessment report on Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/HMPC/39455/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-sideritis-scardica-griseb-sideritis-clandestina-bory-chaub-hayek-sideritis-raeseri-boiss-heldr-sideritis-syriaca-l-herba_en.pdf"},
    {"id":"3610","name":"Presentation - Workshop on patient’s voice in the evaluation of medicines - CPMP / CHMP consultations with patients on benefits/risks(Franà§ois Houà¿ez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T01:00:00Z","last_updated_date":"2013-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patients-voice-evaluation-medicines-cpmp-chmp-consultations-patients-benefitsrisksfranassois-houaez_en.pdf"},
    {"id":"3611","name":"Submission of comments on Guideline on Similar Biological Medicinal Products containing biotechnology derived products as active substance: non-clinical and clinical issues Annex: recombinant\n\nErythropoietin containing p...","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-03-01T01:00:00Z","last_updated_date":"2006-03-01T01:00:00Z","reference_number":"EMEA/CHMP/BMWP/149141/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/submission-comments-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-products-active-substance-non-clinical-and-clinical-issues-annex-recombinant-erythropoietin_en.pdf"},
    {"id":"3612","name":"Presentation - Agenda item 5: organisations - Reports from  subgroup","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-10-29T01:00:00Z","last_updated_date":"2015-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-item-5-organisations-reports-subgroup_en.pdf"},
    {"id":"3614","name":"Peforelin - Summary report of the CVMP on the establishment of maximum residue limits","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-03-29T02:00:00Z","last_updated_date":"2012-03-29T02:00:00Z","reference_number":"EMEA/CVMP/111444/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/peforelin-summary-report-cvmp-establishment-maximum-residue-limits_en.pdf"},
    {"id":"3616","name":"Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2013","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2014-02-03T14:00:00Z","last_updated_date":"2014-02-03T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-dialogue-meeting-december-2013_en.pdf"},
    {"id":"3617","name":"Overview of comments received on reflection paper on publication of withdrawals","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-10-05T02:00:00Z","last_updated_date":"2006-10-05T02:00:00Z","reference_number":"EMEA/148035/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-reflection-paper-publication-withdrawals_en.pdf"},
    {"id":"3618","name":"Overview of comments received on European Union herbal monograph on Matricaria recutita L., flos - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-05T17:30:00Z","last_updated_date":"2016-04-05T17:30:00Z","reference_number":"EMA/HMPC/706538/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-matricaria-recutita-l-flos-first-version_en.pdf"},
    {"id":"3619","name":"Overview of comments received on 'Vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance’ (EMA/CHMP/476248/2016)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-03-03T01:00:00Z","last_updated_date":"2017-03-03T01:00:00Z","reference_number":"EMA/CHMP/803499/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-vemurafenib-film-coated-tablets-240-mg-product-specific-bioequivalence-guidance-emachmp4762482016_en.pdf"},
    {"id":"3620","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - October 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-11-08T12:18:00Z","last_updated_date":"2011-11-08T12:18:00Z","reference_number":"EMA/CVMP/832227/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-october-2011_en.pdf"},
    {"id":"3621","name":"Work programme for the European Agency for the Evaluation of Medicinal Products 2003","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2003-06-12T02:09:21Z","last_updated_date":"2003-06-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_es.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_de.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2003_sv.pdf"}},
    {"id":"3622","name":"Presentation - Breakout session 4: Special issues","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-27T17:35:00Z","last_updated_date":"2013-11-27T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-4-special-issues_en.pdf"},
    {"id":"3623","name":"Review of field safety data by the European Medicines Agency finds a goodsafety record for inactivated bluetongue emergency vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-20T01:00:00Z","last_updated_date":"2009-02-20T01:00:00Z","reference_number":"EMEA/56794/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-field-safety-data-european-medicines-agency-finds-goodsafety-record-inactivated-bluetongue-emergency-vaccines_en.pdf"},
    {"id":"3624","name":"European Medicines Agency letter of arrangement with the World Health Organization (WHO) and the Uppsala Monitoring Centre (UMC) for making available EU adverse reaction reports","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-letter-arrangement-world-health-organization-who-and-uppsala-monitoring-centre-umc-making-available-eu-adverse-reaction-reports_en.pdf"},
    {"id":"3626","name":"CHMP post-authorisation summary of positive opinion for Vectibix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/494254/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vectibix_en.pdf"},
    {"id":"3628","name":"Withdrawal letter: Osseor","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-osseor_en.pdf"},
    {"id":"3629","name":"Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Coversyl and associated names (see Annex I) International Non-Proprietary Name (INN): perindopril: Background information...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-12-05T00:08:21Z","last_updated_date":"2003-12-05T00:08:21Z","reference_number":"CPMP/32703/03","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-pursuant-article-30-council-directive-200183ec-coversyl-and-associated-names-see-annex-i-international-non-proprietary-name-inn-perindopril-background-information_en.pdf"},
    {"id":"3630","name":"CVMP post-authorisation summary of positive opinion for Poulvac E. coli","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-19T01:00:00Z","last_updated_date":"2016-02-19T01:00:00Z","reference_number":"EMA/CVMP/45330/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-poulvac-e-coli_en.pdf"},
    {"id":"3632","name":"Pholcodine - Article 31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-03-28T02:00:00Z","last_updated_date":"2012-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/pholcodine-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/pholcodine-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/pholcodine-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/pholcodine-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/pholcodine-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/pholcodine-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/pholcodine-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/pholcodine-article-31-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/pholcodine-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/pholcodine-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/pholcodine-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/pholcodine-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/pholcodine-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/pholcodine-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/pholcodine-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/pholcodine-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/pholcodine-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/pholcodine-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/pholcodine-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/pholcodine-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/pholcodine-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"3633","name":"Evaluation of the Soluble and Solid Phase Cytokine Release Assay: Thomas Kawabata, Pfizer, St. Louis, MO.","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/evaluation-soluble-and-solid-phase-cytokine-release-assay-thomas-kawabata-pfizer-st-louis-mo_en.pdf"},
    {"id":"3634","name":"Agenda - Conference on environmental risk assessment For human and veterinary medicinal products","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2005-10-27T02:09:21Z","last_updated_date":"2005-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-conference-environmental-risk-assessment-human-and-veterinary-medicinal-products_en.pdf"},
    {"id":"3638","name":"Overview of comments on draft Community herbal monograph on Lavandula angustifolia Miller, aetheroleum","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2012-06-13T18:00:00Z","last_updated_date":"2012-06-13T18:00:00Z","reference_number":"EMA/HMPC/734381/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-draft-community-herbal-monograph-lavandula-angustifolia-miller-aetheroleum_en.pdf"},
    {"id":"3640","name":"Compilation of individual product-specific guidance on demonstration of bioequivalence","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-04-10T15:50:00Z","last_updated_date":"2015-04-10T15:50:00Z","reference_number":"EMA/CHMP/736403/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/compilation-individual-product-specific-guidance-demonstration-bioequivalence_en.pdf"},
    {"id":"3641","name":"CHMP post-authorisation summary of positive opinion for Volibris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/CHMP/605508/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-volibris_en.pdf"},
    {"id":"3642","name":"Towards improving the availability of medicines in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-08-29T14:00:00Z","last_updated_date":"2018-08-29T14:00:00Z","reference_number":"EMA/485874/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/towards-improving-availability-medicines-eu_en.pdf"},
    {"id":"3643","name":"Presentation - Difficulties encountered - regulatory perspective: focus on endpoints used in clinical trials (Concha Prieto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-difficulties-encountered-regulatory-perspective-focus-endpoints-used-clinical-trials-concha-prieto_en.pdf"},
    {"id":"3647","name":"Presentation - Pharmacokinetic-pharmacodynamic modelling to support go / no-go decisions for a novel gp120 inhibitor - Break-out session 1 theme 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:45:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacokinetic-pharmacodynamic-modelling-support-go-no-go-decisions-novel-gp120-inhibitor-break-out-session-1-theme-3_en.pdf"},
    {"id":"3649","name":"EU/3/17/1887: Public summary of opinion on orphan designation: Synthetic glucagon analogue modified to contain 7 amino acid substitutions for the treatment of congenital hyperinsulinism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/326123/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171887-public-summary-opinion-orphan-designation-synthetic-glucagon-analogue-modified-contain-7-amino-acid-substitutions-treatment-congenital-hyperinsulinism_en.pdf"},
    {"id":"3651","name":"European Medicines Agency Management Board holds its 50th meeting:\n\nAnnual report 2005 shows a reduction in applications for new medicines\n\nbut suggests increases in the years to come","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-20T00:09:21Z","last_updated_date":"2006-03-20T00:09:21Z","reference_number":"EMEA/88535/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-management-board-holds-its-50th-meeting-annual-report-2005-shows-reduction-applications-new-medicines-suggests-increases-years-come_en.pdf"},
    {"id":"3653","name":"Commission Regulation (EU) No 301/2011 of 28 March 2011 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2011-03-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/commission-regulation-eu-no-3012011-28-march-2011-amending-council-regulation-ec-no-29795-regards-adjustment-fees-european-medicines-agency-inflation-rate_en.pdf"},
    {"id":"3654","name":"Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - Condition specific guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-10-07T16:30:00Z","last_updated_date":"2015-10-07T16:30:00Z","reference_number":"EMA/CHMP/703715/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/appendix-4-guideline-evaluation-anticancer-medicinal-products-man-condition-specific-guidance-revision-1_en.pdf"},
    {"id":"3657","name":"European Commission-Japan mutual recognition agreement: Sectoral annex on good manufacturing practice - Second sub-committee meeting, 30 June 2003, joint common statement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2003-06-30T02:00:00Z","last_updated_date":"2003-06-30T02:00:00Z","reference_number":"EMEA/INS/MRA/JP/85/03","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-japan-mutual-recognition-agreement-sectoral-annex-good-manufacturing-practice-second-sub-committee-meeting-30-june-2003-joint-common-statement_en.pdf"},
    {"id":"3658","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12-14 February 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T16:50:00Z","last_updated_date":"2014-02-21T16:50:00Z","reference_number":"EMA/PDCO/60726/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-14-february-2014_en.pdf"},
    {"id":"3659","name":"EU/3/11/898: Public summary of opinion on orphan designation: Sirolimus for the treatment of chronic non-infectious uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-09-21T02:00:00Z","last_updated_date":"2022-08-30T11:55:00Z","reference_number":"EMA/COMP/508827/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311898-public-summary-opinion-orphan-designation-sirolimus-treatment-chronic-non-infectious-uveitis_en.pdf"},
    {"id":"3660","name":"Scientific recommendation on classification of advanced therapy medicinal products: Nuclease resistant, synthetic double-stranded small interfering RNA (siRNA)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-25T18:00:00Z","last_updated_date":"2017-10-25T18:00:00Z","reference_number":"EMA/665133/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-nuclease-resistant-synthetic-double-stranded-small-interfering-rna-sirna_en.pdf"},
    {"id":"3661","name":"Ginkgo leaf - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-12-14T01:00:00Z","reference_number":"EMA/HMPC/324406/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/ginkgo-leaf-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/ginkgo-leaf-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/ginkgo-leaf-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/ginkgo-leaf-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/ginkgo-leaf-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/ginkgo-leaf-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/ginkgo-leaf-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/ginkgo-leaf-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/ginkgo-leaf-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/ginkgo-leaf-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/ginkgo-leaf-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/ginkgo-leaf-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/ginkgo-leaf-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/ginkgo-leaf-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/ginkgo-leaf-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/ginkgo-leaf-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/ginkgo-leaf-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/ginkgo-leaf-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/ginkgo-leaf-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/ginkgo-leaf-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/ginkgo-leaf-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/ginkgo-leaf-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/ginkgo-leaf-summary-public_sv.pdf"}},
    {"id":"3663","name":"Day 120 draft list of questions template (Word) - September 2009","type":"template-form","status":"Draft","consultation_date":"","first_published_date":"2009-09-01T02:09:21Z","last_updated_date":"2009-09-01T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-120-draft-list-questions-template-word-september-2009_en.doc"},
    {"id":"3664","name":"Reminder card for Aclasta","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T13:00:00Z","last_updated_date":"2015-03-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/reminder-card-aclasta_en.pdf"},
    {"id":"3665","name":"Docetaxel Teva Generics - Article 29 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-07-03T02:00:00Z","last_updated_date":"2012-07-03T02:00:00Z","reference_number":"EMA/586425/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/docetaxel-teva-generics-article-29-referral-assessment-report_en.pdf"},
    {"id":"3667","name":"EU/3/15/1478: Public summary of positive opinion for orphan designation of Rimeporide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-21T14:00:00Z","last_updated_date":"2015-05-21T14:00:00Z","reference_number":"EMA/COMP/211156/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151478-public-summary-positive-opinion-orphan-designation-rimeporide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"3668","name":"EU/3/09/714: Public summary of opinion on orphan designation of Streptococcus pyogenes Su strain cells treated with benzylpenicillin for the treatment of congenital lymphatic malformations","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2011-09-06T02:00:00Z","reference_number":"EMA/743702/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309714-public-summary-opinion-orphan-designation-streptococcus-pyogenes-su-strain-cells-treated-benzylpenicillin-treatment-congenital-lymphatic-malformations_en.pdf"},
    {"id":"3669","name":"Streptomycin and dihydrostreptomycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/008/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/streptomycin-and-dihydrostreptomycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"3670","name":"EU/3/13/1174: Public summary of opinion on orphan designation: Trans-N1-((1R,2S)-2-phenylcyclopropyl)cyclohexane-1,4-diamine bis-hydrochloride for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-12T02:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/COMP/432481/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131174-public-summary-opinion-orphan-designation-trans-n1-1r2s-2-phenylcyclopropylcyclohexane-14-diamine-bis-hydrochloride-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"3672","name":"Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-10T18:50:00Z","last_updated_date":"2018-09-10T18:53:21Z","reference_number":"EMA/608492/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/betahistine-list-nationally-authorised-medicinal-products-psusa00000389201712_en.pdf"},
    {"id":"3674","name":"Shedding after in situ rAAV delivery - Review of the literature and 8 years of experience in Nantes in large animal models - Caroline Le Guiner","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/shedding-after-situ-raav-delivery-review-literature-and-8-years-experience-nantes-large-animal-models-caroline-le-guiner_en.pdf"},
    {"id":"3675","name":"Summary of transfers of appropriations in the budget 2009 - Management Board meeting 18 March 2010","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/MB/97480/2010","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfers-appropriations-budget-2009-management-board-meeting-18-march-2010_en.pdf"},
    {"id":"3676","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Defitelio (defibrotide) for the treatment of hepatic veno-occlusive disease","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2013-11-11T12:00:00Z","last_updated_date":"2013-11-11T12:00:00Z","reference_number":"EMA/COMP/536533/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-defitelio-defibrotide-treatment-hepatic-veno-occlusive-disease_en.pdf"},
    {"id":"3678","name":"EU/3/16/1615: Public summary of opinion on orphan designation: 2-Ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/72050/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161615-public-summary-opinion-orphan-designation-2-ethylbutyl-2s-2-s-2r3s4r5r-5-4-aminopyrrolo21-f124triazin-7-yl-5-cyano-34-dihydroxytetrahydrofuran-2-ylmethoxyphenoxyphosphoryl_en.pdf"},
    {"id":"3679","name":"Presentation - Implementation of risk minimisation measures in clinical practice: Challenges and opportunities (Jamie Wilkinson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-01T01:00:00Z","last_updated_date":"2017-03-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-risk-minimisation-measures-clinical-practice-challenges-and-opportunities-jamie-wilkinson_en.pdf"},
    {"id":"3680","name":"EU/3/05/279: Public summary of positive opinion for orphan designation of (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone for ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMEA/COMP/122781/2005 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305279-public-summary-positive-opinion-orphan-designation-e-1s4s10s21r-7-z-ethylidene-421-diisopropyl-2-oxa-1213-dithia-582023-tetraazabicyclo876tricos-16-ene-3691922-pentone_en.pdf"},
    {"id":"3681","name":"Overview of comments received on draft appendix 2 to the guideline on the evaluation of anticancer medicinal products in man (CPMP/EWP/205/95 Rev.3) on confirmatory studies in haematological malignancies","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-03T01:09:21Z","last_updated_date":"2010-03-03T01:09:21Z","reference_number":"EMA/574487/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-appendix-2-guideline-evaluation-anticancer-medicinal-products-man-cpmpewp20595-rev3-confirmatory-studies-haematological-malignancies_en.pdf"},
    {"id":"3683","name":"Report of meeting held with GIRP - European Association of Pharmaceutical Full-line Wholesalers","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T02:00:00Z","last_updated_date":"2015-10-06T02:00:00Z","reference_number":"EMA/625931/2015","document_url":"https://www.ema.europa.eu/en/documents/report/report-meeting-held-girp-european-association-pharmaceutical-full-line-wholesalers_en.pdf"},
    {"id":"3688","name":"CVMP summary of positive opinion for Versican Plus Pi/L4R","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/CVMP/301696/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-versican-plus-pil4r_en.pdf"},
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    {"id":"3748","name":"Ketamine: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-12-01T01:00:00Z","last_updated_date":"1997-12-01T01:00:00Z","reference_number":"EMEEA/MRL/315/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ketamine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"3749","name":"Presentation -  MUMS Designation and latest develompments (Karen Quigley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mums-designation-and-latest-develompments-karen-quigley_en.pdf"},
    {"id":"3750","name":"Wyeth Consumer Healthcare withdraws its marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-13T01:00:00Z","last_updated_date":"2010-01-13T01:00:00Z","reference_number":"EMA/23476/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/wyeth-consumer-healthcare-withdraws-its-marketing-authorisation-application-ibuprofendiphenhydramine-hydrochloride-wyeth_en.pdf"},
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    {"id":"3753","name":"Omeprazole: List of nationally authorised medicinal products - PSUSA/00002215/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T16:00:00Z","last_updated_date":"2017-12-08T16:00:00Z","reference_number":"EMA/817628/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/omeprazole-list-nationally-authorised-medicinal-products-psusa00002215201704_en.pdf"},
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    {"id":"3758","name":"Varicella zoster-immunoglobulin : List of nationally authorised medicinal products - PSUSA/00010266/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-07T16:43:00Z","last_updated_date":"2017-09-07T16:45:18Z","reference_number":"EMA/594374/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/varicella-zoster-immunoglobulin-list-nationally-authorised-medicinal-products-psusa00010266201612_en.pdf"},
    {"id":"3759","name":"Draft guideline on parametric release","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-03-15T01:00:00Z","last_updated_date":"2006-03-15T01:00:00Z","reference_number":"EMEA/CVMP/QWP/339588/2005-Cons.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-parametric-release_en.pdf"},
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    {"id":"3765","name":"Template letter for applicant - waiving right for a re-examination request","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:21Z","last_updated_date":"2013-08-07T16:22:00Z","reference_number":"n/a","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-letter-applicant-waiving-right-re-examination-request_en.doc"},
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    {"id":"3771","name":"European Commission legalisation of EMEA certificates to end","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-10-28T02:00:00Z","last_updated_date":"2005-10-28T02:00:00Z","reference_number":"EMEA/351182/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-commission-legalisation-emea-certificates-end_en.pdf"},
    {"id":"3775","name":"Presentation - Stakeholder experiences: Benefits of AE Reporting by AVC","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stakeholder-experiences-benefits-ae-reporting-avc_en.pdf"},
    {"id":"3776","name":"EU/3/16/1673: Public summary of opinion on orphan designation: Pyridoxine and L-pyroglutamic acid for the treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/396049/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161673-public-summary-opinion-orphan-designation-pyridoxine-and-l-pyroglutamic-acid-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"3778","name":"EU/3/14/1410: Public summary of opinion on orphan designation: Recombinant human aspartylglucosaminidase for the treatment of aspartylglucosaminuria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2021-06-25T01:00:00Z","reference_number":"EMA/COMP/10141/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141410-public-summary-opinion-orphan-designation-recombinant-human-aspartylglucosaminidase-treatment-aspartylglucosaminuria_en.pdf"},
    {"id":"3779","name":"Advanced-therapy medicinal products and the CAT","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2016-11-08T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/advanced-therapy-medicinal-products-and-cat_en.pdf"},
    {"id":"3784","name":"EMLA cream Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/emla-cream-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/emla-cream-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/emla-cream-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/emla-cream-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/emla-cream-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/emla-cream-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/emla-cream-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/emla-cream-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/emla-cream-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/emla-cream-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/emla-cream-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/emla-cream-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/emla-cream-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/emla-cream-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/emla-cream-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/emla-cream-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/emla-cream-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/emla-cream-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/emla-cream-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/emla-cream-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/emla-cream-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/emla-cream-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/emla-cream-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/emla-cream-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/emla-cream-article-30-referral-annex-iii_no.pdf"}},
    {"id":"3785","name":"Guidelines and concept papers adopted during the CHMP meeting 22-25 April 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-02T14:15:00Z","last_updated_date":"2013-05-02T14:15:00Z","reference_number":"EMA/CHMP/184562/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-22-25-april-2013_en.pdf"},
    {"id":"3788","name":"Overview of comments received on 'Detailed Guide regarding the Monitoring of Medical Literature and the Entry of Relevant Information into the EudraVigilance Database by the European Medicines Agency on Literature Monito...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-05-12T14:30:00Z","last_updated_date":"2015-05-12T14:30:00Z","reference_number":"EMA/716877/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-detailed-guide-regarding-monitoring-medical-literature-and-entry-relevant-information-eudravigilance-database-european-medicines-agency-literature-monito_en.pdf"},
    {"id":"3789","name":"EU/3/13/1196: Public summary of opinion on orphan designation:\n\nAutologous CD34+ cells transduced with a lentiviral vector containing the human Wiskott-Aldrich syndrome gene for the treatment of Wiskott-Aldrich syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2013-10-31T01:00:00Z","reference_number":"EMA/COMP/553057/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131196-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-wiskott-aldrich-syndrome-gene-treatment-wiskott-aldrich-syndrome_en.pdf"},
    {"id":"3793","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2015-03-13T01:09:21Z","reference_number":"EMEA/HMPC/453698/2007EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"3796","name":"Agenda - CAT agenda of the 6-8 December 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-12-08T17:21:00Z","last_updated_date":"2017-12-08T17:21:00Z","reference_number":"EMA/CAT/815841/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-6-8-december-2017-meeting_en.pdf"},
    {"id":"3798","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 18-21 May 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-05-26T16:00:00Z","last_updated_date":"2015-05-26T16:00:00Z","reference_number":"EMA/28012/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-18-21-may-2015_en.pdf"},
    {"id":"3801","name":"European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/84749/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/european-medicines-agency-recommends-protelososseor-remain-available-further-restrictions_en.pdf"},
    {"id":"3802","name":"Public bulletin: Veterinary pharmacovigilance 2016","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T15:30:00Z","last_updated_date":"2017-02-24T15:30:00Z","reference_number":"EMA/568976/2016","document_url":"https://www.ema.europa.eu/en/documents/newsletter/public-bulletin-veterinary-pharmacovigilance-2016_en.pdf"},
    {"id":"3805","name":"Difloxacin (Modification): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-01-01T01:00:00Z","last_updated_date":"1997-01-01T01:00:00Z","reference_number":"EMEA/MRL/154/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/difloxacin-modification-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"3808","name":"Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-06T17:20:00Z","last_updated_date":"2017-11-06T17:23:00Z","reference_number":"EMA/726434/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/triamcinolone-intraocular-formulations-list-nationally-authorised-medicinal-products-psusa00010292201703_en.pdf"},
    {"id":"3810","name":"CHMP summary of positive opinion for Lonsurf","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/CHMP/130102/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lonsurf_en.pdf"},
    {"id":"3811","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Community Authorisation for Veterinary Medicines-the Contribution to Animal Health in the EU - Paul-Pierre Pastoret","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-community-authorisation-veterinary-medicines-contribution-animal-health-eu-paul-pierre-pastoret_en.pdf"},
    {"id":"3813","name":"Presentation - Subjective cognitive decline as the first symptom of Alzheimer’s disease (Frank Jessen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subjective-cognitive-decline-first-symptom-alzheimers-disease-frank-jessen_en.pdf"},
    {"id":"3814","name":"Scientific recommendation on classification of advanced therapy medicinal products: CD1c (BDCA-1)+ myeloid dendritic cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/65746/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cd1c-bdca-1-myeloid-dendritic-cells_en.pdf"},
    {"id":"3816","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"EMA/199242/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-review-started_en.pdf"},
    {"id":"3818","name":"Scientific advice and protocol assistance - Adopted during the CHMP meeting 15-18 October 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-19T14:29:00Z","last_updated_date":"2012-10-19T14:29:00Z","reference_number":"EMA/CHMP/SAWP/667462/2012","document_url":"https://www.ema.europa.eu/en/documents/other/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-15-18-october-2012_en.pdf"},
    {"id":"3819","name":"Guidelines on good pharmacovigilance practices: Annex I - Definitions (Rev 1) (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T11:00:00Z","last_updated_date":"2012-06-25T11:00:00Z","reference_number":"EMA/876333/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-good-pharmacovigilance-practices-annex-i-definitions-rev-1-superseded_en.pdf"},
    {"id":"3822","name":"CHMP summary of opinion for Pandemic influenza vaccine H5N1 MedImmune","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/170789/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-pandemic-influenza-vaccine-h5n1-medimmune_en.pdf"},
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    {"id":"3824","name":"EU/3/12/1081 : Public summary of opinion on orphan designation: Triheptanoin for the treatment of very-long-chain 3-hydroxyacyl-CoA-dehydrogenase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2016-08-12T16:00:00Z","reference_number":"EMA/COMP/744220/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121081-public-summary-opinion-orphan-designation-triheptanoin-treatment-very-long-chain-3-hydroxyacyl-coa-dehydrogenase-deficiency_en.pdf"},
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    {"id":"3830","name":"Draft appendices to draft proposal for an addendum, on transparency, to the 'Functional specifications for the European Union portal and EU database to be audited'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-21T13:00:00Z","last_updated_date":"2015-01-21T13:00:00Z","reference_number":"EMA/768628/2014","document_url":"https://www.ema.europa.eu/en/documents/other/draft-appendices-draft-proposal-addendum-transparency-functional-specifications-european-union-portal-and-eu-database-be-audited_en.pdf"},
    {"id":"3831","name":"European Medicines Agency and European Commission start reflection process on way forward for the Agency and the network","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-08T02:00:00Z","last_updated_date":"2010-07-08T02:00:00Z","reference_number":"EMA/422535/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-european-commission-start-reflection-process-way-forward-agency-and-network_en.pdf"},
    {"id":"3832","name":"Overview of comments on guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH) (EMA/CHMP/BMWP/671292/2010)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-06T12:00:04Z","last_updated_date":"2013-03-06T12:00:04Z","reference_number":"EMA/92876/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-follicle-stimulating-hormone-r-hfsh-emachmpbmwp6712922010_en.pdf"},
    {"id":"3833","name":"Bemetizide / triamterene: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009076/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-21T02:00:00Z","last_updated_date":"2016-10-18T14:01:11Z","reference_number":"EMA/285585/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/bemetizide-triamterene-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00009076201506_en.pdf"},
    {"id":"3834","name":"Omeprazole: Summary Report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-06-01T02:00:00Z","last_updated_date":"2002-06-01T02:00:00Z","reference_number":"EMEA/MRL/841/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/omeprazole-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"3835","name":"Long-term PHARMacovigilance for Adverse effects in Childhood arthritis focusing on Immune modulatory drugs, Dr Nico Wulffraat","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/long-term-pharmacovigilance-adverse-effects-childhood-arthritis-focusing-immune-modulatory-drugs-dr-nico-wulffraat_en.pdf"},
    {"id":"3836","name":"Presentation - How to make compassionate use become a reality for all in need (F.Houà¿ez, EURORDIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T02:00:00Z","last_updated_date":"2017-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-make-compassionate-use-become-reality-all-need-fhouaez-eurordis_en.pdf"},
    {"id":"3838","name":"CHMP summary of positive opinion for Suliqua","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/715538/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-suliqua_en.pdf"},
    {"id":"3844","name":"Agenda - European network of paediatric research-European Medicines Agency meeting: rare gastrointestinal and liver diseases initiative (morning session)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-11-19T11:00:00Z","last_updated_date":"2015-11-19T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-network-paediatric-research-european-medicines-agency-meeting-rare-gastrointestinal-and-liver-diseases-initiative-morning-session_en.pdf"},
    {"id":"3845","name":"Committee for veterinary medicinal products: 52nd meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2000-02-10T00:09:21Z","last_updated_date":"2000-02-10T00:09:21Z","reference_number":"EMEA/CVMP/117/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-52nd-meeting_en.pdf"},
    {"id":"3848","name":"Superseded assessment report on Olea europaea L., folium - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-04-18T17:30:00Z","last_updated_date":"2012-04-18T17:30:00Z","reference_number":"EMA/HMPC/430506/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-olea-europaea-l-folium-first-version_en.pdf"},
    {"id":"3850","name":"Overview of comments received on reflection paper on assessment of bioavailability of bound residues in food commodities of animal origin in the context of council regulation (EEC) NO 2377/90","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-09-22T02:00:00Z","last_updated_date":"2008-09-22T02:00:00Z","reference_number":"EMEA/213492/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-assessment-bioavailability-bound-residues-food-commodities-animal-origin-context-council-regulation-eec-no-237790_en.pdf"},
    {"id":"3853","name":"Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP)","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-09-17T14:00:00Z","last_updated_date":"2018-11-08T17:00:00Z","reference_number":"EMA/610994/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp_en.pdf"},
    {"id":"3856","name":"Carboplatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"3858","name":"Legacy product data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-07T18:10:00Z","last_updated_date":"2013-11-07T18:10:00Z","reference_number":"EMA/656849/2013","document_url":"https://www.ema.europa.eu/en/documents/other/legacy-product-data-extended-eudravigilance-medicinal-product-dictionary-xevmpd_en.pdf"},
    {"id":"3861","name":"Work instructions for organising a EudraVigilance reporting review meeting with stakeholders","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-06-26T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"WIN/H/3209","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-organising-eudravigilance-reporting-review-meeting-stakeholders_en.pdf"},
    {"id":"3865","name":"Presentation - The interface between Industry – CRO and Clinical Trials Networks: Defining the roles (Martine Dehlinger-Kremer, RPS Inc. / EUCROF)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interface-between-industry-cro-and-clinical-trials-networks-defining-roles-martine-dehlinger-kremer-rps-inc-eucrof_en.pdf"},
    {"id":"3866","name":"Draft list of references supporting the assessment of Cimicifuga racemosa (L.) Nutt., rhizome - Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2017-08-04T02:00:00Z","last_updated_date":"2017-08-04T02:00:00Z","reference_number":"EMA/HMPC/193919/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-cimicifuga-racemosa-l-nutt-rhizome-revision-1_en.pdf"},
    {"id":"3871","name":"EU/3/12/996: Public summary of opinion on orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the treatment of meningioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2012-07-04T17:00:00Z","reference_number":"EMA/COMP/285075/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312996-public-summary-opinion-orphan-designation-n-hydroxy-4-3-methyl-2-s-phenyl-butyrylamino-benzamide-treatment-meningioma_en.pdf"},
    {"id":"3872","name":"Guideline on user safety of topically administered veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-05-07T13:45:00Z","last_updated_date":"2018-05-07T13:45:00Z","reference_number":"EMA/CVMP/SWP/721059/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-user-safety-topically-administered-veterinary-medicinal-products_en.pdf"},
    {"id":"3873","name":"Meeting highlights from the Paediatric Committee: 22 - 24 July 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-07-31T02:00:00Z","last_updated_date":"2009-07-31T02:00:00Z","reference_number":"EMEA/PDCO/449592/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-22-24-july-2009_en.pdf"},
    {"id":"3874","name":"EU/3/16/1612: Public summary of opinion on orphan designation: Methyl 3-((2R)-2-hydroxy-4-(((((S)-1-methoxy-1-oxopropan-2-yl) amino)(phenoxy)phosphoryl)oxy)-3,3-dimethylbutanamido)propanoate for the treatment of pantothe...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2020-08-13T02:00:00Z","reference_number":"EMA/COMP/63648/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161612-public-summary-opinion-orphan-designation-methyl-3-2r-2-hydroxy-4-s-1-methoxy-1-oxopropan-2-yl-aminophenoxyphosphoryloxy-33-dimethylbutanamidopropanoate-treatment-pantothe_en.pdf"},
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    {"id":"3884","name":"Architect/Building engineer - Exclusion criteria declaration form - EMA/CEI/2018-2","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-09-10T12:30:00Z","last_updated_date":"2018-09-10T12:30:00Z","reference_number":"EMA/CEI/2018-2","document_url":"https://www.ema.europa.eu/en/documents/template-form/architectbuilding-engineer-exclusion-criteria-declaration-form-emacei2018-2_en.docx"},
    {"id":"3888","name":"Assessment report for calcitonin containing medicinal products","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-07-19T02:00:00Z","last_updated_date":"2013-07-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-calcitonin-containing-medicinal-products_en.pdf"},
    {"id":"3889","name":"Annual list of contractor modifications 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-28T17:00:00Z","last_updated_date":"2017-06-28T17:00:00Z","reference_number":"EMA/398274/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annual-list-contractor-modifications-2016_en.pdf"},
    {"id":"3890","name":"EU/3/11/937: Public summary of opinion on orphan designation: Alpha-tocotrienol quinone for the treatment of Leigh syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/COMP/870527/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311937-public-summary-opinion-orphan-designation-alpha-tocotrienol-quinone-treatment-leigh-syndrome_en.pdf"},
    {"id":"3891","name":"EMEA half-year report for 2008 shows activities to be on target, with a marked increase in the provision of scientific advice","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-08T02:00:00Z","last_updated_date":"2008-10-08T02:00:00Z","reference_number":"EMEA/MB/521956/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-half-year-report-2008-shows-activities-be-target-marked-increase-provision-scientific-advice_en.pdf"},
    {"id":"3892","name":"Presentation - European Medicines Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T16:00:00Z","last_updated_date":"2016-02-15T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency_en.pdf"},
    {"id":"3893","name":"Final assessment report on Sambucus nigra L., fructus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-04-29T02:00:00Z","last_updated_date":"2014-04-29T02:00:00Z","reference_number":"EMA/HMPC/44208/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"3895","name":"Presentation - PIP session: Paediatric glaucoma","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pip-session-paediatric-glaucoma_en.pdf"},
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    {"id":"3897","name":"Commitee for Orphan Medicinal Products: September 2004 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-09-14T02:00:00Z","last_updated_date":"2004-09-14T02:00:00Z","reference_number":"EMEA/COMP/65396/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/commitee-orphan-medicinal-products-september-2004-meeting_en.pdf"},
    {"id":"3898","name":"Annua Report 2014 - Veterinary medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-30T02:00:00Z","last_updated_date":"2015-04-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annua-report-2014-veterinary-medicines_en.pdf"},
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    {"id":"3910","name":"9-10 June: Sà©minaire sur les dà©veloppements rà©cents en Pharmacovigilance europà©enne et la gestion du risque (Vukovar) - Announcement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-06-09T02:09:21Z","last_updated_date":"2008-06-09T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/9-10-june-sacminaire-sur-les-dacveloppements-raccents-en-pharmacovigilance-europacenne-et-la-gestion-du-risque-vukovar-announcement_en.pdf"},
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    {"id":"3914","name":"Concept paper on the development of a Guideline on clinical monitoring and follow-up of patients exposed to gene therapy/gene transfer medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-04-26T02:00:00Z","last_updated_date":"2007-04-26T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/367513/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-clinical-monitoring-and-follow-patients-exposed-gene-therapygene-transfer-medicinal-products_en.pdf"},
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    {"id":"3950","name":"Withdrawal assessment report for: Balimek (binimetinib)","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2018-03-27T17:11:00Z","last_updated_date":"2018-03-27T17:11:00Z","reference_number":"EMA/CHMP/86716/2018","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-balimek-binimetinib_en.pdf"},
    {"id":"3951","name":"EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 3.2","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-10-21T02:00:00Z","last_updated_date":"2008-10-21T02:00:00Z","reference_number":"EMEA/560457/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-expert-working-group-volume-9a-implementation-questions-and-answers-version-32_en.pdf"},
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    {"id":"3957","name":"Schering-Plough Europe withdraws its marketing authorisation application\n\nfor Garenoxacin mesylate","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-26T02:09:21Z","last_updated_date":"2007-07-26T02:09:21Z","reference_number":"EMEA/341174/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/schering-plough-europe-withdraws-its-marketing-authorisation-application-garenoxacin-mesylate_en.pdf"},
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    {"id":"3963","name":"Committee for medicinal products for veterinary use: Meeting of 12 - 14 June 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T14:49:21Z","last_updated_date":"2007-06-15T14:49:21Z","reference_number":"EMEA/CVMP/239756/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-12-14-june-2007_en.pdf"},
    {"id":"3965","name":"Presentation - Adverse reactions from medication errors: regulatory experience in European Union (Dolores Montero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adverse-reactions-medication-errors-regulatory-experience-european-union-dolores-montero_en.pdf"},
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    {"id":"3969","name":"Pathogen-specific database: Tularemia","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-tularemia_en.pdf"},
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    {"id":"3973","name":"Superseded Community herbal monograph on Plantago ovate Forssk., seminis tegumentum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMEA/HMPC/340857/2005","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-plantago-ovate-forssk-seminis-tegumentum_en.pdf"},
    {"id":"3974","name":"Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-11-19T00:09:21Z","last_updated_date":"2009-11-19T00:09:21Z","reference_number":"EMEA/749487/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/otsuka-pharmaceutical-europe-ltd-withdraws-its-application-extension-indication-abilify-aripiprazole_en.pdf"},
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    {"id":"4016","name":"European Medicines Agency and EUnetHTA agree joint work plan","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-eunethta-agree-joint-work-plan_en.pdf"},
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    {"id":"4045","name":"Presentation - Setting specifications for biotech products, Nanna Aaby Kruse, Danish Medicines Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T02:00:00Z","last_updated_date":"2011-10-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-setting-specifications-biotech-products-nanna-aaby-kruse-danish-medicines-agency_en.pdf"},
    {"id":"4047","name":"VICH GL17: Stability testing of biotechnological/biological veterinary medicinal products - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-06-01T02:00:00Z","last_updated_date":"2000-06-01T02:00:00Z","reference_number":"CVMP/VICH/501/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl17-stability-testing-biotechnologicalbiological-veterinary-medicinal-products-step-7_en.pdf"},
    {"id":"4050","name":"Avinew- Article 18 Referral - Summary of product characteristics of the reference member state","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-01-02T00:59:00Z","last_updated_date":"2002-01-02T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/avinew-article-18-referral-summary-product-characteristics-reference-member-state_sv.pdf"}},
    {"id":"4051","name":"Presentation - Safe medication practice – What can we learn from root cause analysis and related methods? (David Gerrett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-01T01:00:00Z","last_updated_date":"2017-03-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-safe-medication-practice-what-can-we-learn-root-cause-analysis-and-related-methods-david-gerrett_en.pdf"},
    {"id":"4052","name":"Final assessment report on Passiflora incarnata L., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-06-18T12:05:00Z","last_updated_date":"2014-06-18T12:05:00Z","reference_number":"EMA/HMPC/669738/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-passiflora-incarnata-l-herba_en.pdf"},
    {"id":"4053","name":"CVMP Reflection paper on the use of fluoroquinolones in foodproducing animals in the EU: Development of resistance and impact on human and animal health - Liisa Kaartinen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/cvmp-reflection-paper-use-fluoroquinolones-foodproducing-animals-eu-development-resistance-and-impact-human-and-animal-health-liisa-kaartinen_en.pdf"},
    {"id":"4055","name":"Presentation - Regulation, innovation and personalised medicine","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulation-innovation-and-personalised-medicine_en.pdf"},
    {"id":"4057","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Madrid)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T12:57:00Z","last_updated_date":"2017-06-15T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-madrid_en.pdf"},
    {"id":"4058","name":"Presentation - Mechanism-based concepts of size and maturity","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mechanism-based-concepts-size-and-maturity_en.pdf"},
    {"id":"4059","name":"CVMP post-authorisation summary of positive opinion for Contacera","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-12-13T17:00:00Z","last_updated_date":"2013-12-13T17:00:00Z","reference_number":"EMA/CVMP/694589/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-contacera_en.pdf"},
    {"id":"4060","name":"EU/3/15/1549: Public summary of opinion on orphan designation: Synthetic peptide L-cysteine, L-cysteinylglycyl-L-glutaminyl-L-arginyl-L-.alpha.-glutamyl-L-threonyl-L-prolyl-L-.alpha.-glutamylglycyl-L-alanyl-L-.alpha.-glu...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-16T01:00:00Z","last_updated_date":"2015-11-16T01:00:00Z","reference_number":"EMA/COMP/615274/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151549-public-summary-opinion-orphan-designation-synthetic-peptide-l-cysteine-l-cysteinylglycyl-l-glutaminyl-l-arginyl-l-alpha-glutamyl-l-threonyl-l-prolyl-l-alpha-glutamylglycyl-l-alanyl-l-alpha_en.pdf"},
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    {"id":"4067","name":"Guidelines and concept papers adopted during the CHMP meeting 10-13 December 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-18T17:30:00Z","last_updated_date":"2012-12-18T17:30:00Z","reference_number":"EMA/CHMP/732294/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-10-13-december-2012_en.pdf"},
    {"id":"4069","name":"European Medicines Agency budget for 2007","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2006-12-19T01:00:00Z","last_updated_date":"2006-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2007_en.pdf"},
    {"id":"4071","name":"Semler Article-31 referral – Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/semler-article-31-referral-review-started_en.pdf"},
    {"id":"4072","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - September 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-09-30T02:00:00Z","last_updated_date":"2005-09-30T02:00:00Z","reference_number":"EMEA/324405/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-september-2005_en.pdf"},
    {"id":"4076","name":"Valproate and related substances Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2014-07-11T19:00:00Z","reference_number":"EMA/PRAC/606970/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-and-related-substances-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"4077","name":"Opening up clinical data on new medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T17:00:00Z","last_updated_date":"2016-10-20T17:00:00Z","reference_number":"EMA/650519/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/opening-clinical-data-new-medicines_en.pdf"},
    {"id":"4078","name":"Committee for Medicinal Products for Human Use (CHMP) - June 2009 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-03T02:00:00Z","last_updated_date":"2009-07-03T02:00:00Z","reference_number":"EMEA/CHMP/389326/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-june-2009-plenary-meeting-monthly-report_en.pdf"},
    {"id":"4079","name":"CHMP post-authorisation summary of positive opinion for Kineret","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-02-23T01:00:00Z","reference_number":"EMA/84249/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kineret_en.pdf"},
    {"id":"4080","name":"Update report on the Agency’s European Union Telematics: Operations report (December 2012)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-12-20T01:00:00Z","last_updated_date":"2012-12-20T01:00:00Z","reference_number":"EMA/777362/2012","document_url":"https://www.ema.europa.eu/en/documents/other/update-report-agencys-european-union-telematics-operations-report-december-2012_en.pdf"},
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    {"id":"4086","name":"CHMP post-authorisation summary of positive opinion for Tesavel of 23 April 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/240352/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tesavel-23-april-2009_en.pdf"},
    {"id":"4090","name":"Overview of PIPs and paediatric trials proposed per therapeutic area  - Dr Ralf Herold","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-pips-and-paediatric-trials-proposed-therapeutic-area-dr-ralf-herold_en.pdf"},
    {"id":"4093","name":"Superseded assessment report on Vitex agnus-castus L., fructus - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2018-10-10T02:00:00Z","reference_number":"EMA/HMPC/144003/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-vitex-agnus-castus-l-fructus-first-version_en.pdf"},
    {"id":"4095","name":"Delivery time frame for the EU portal and EU database","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2017-06-16T15:20:00Z","reference_number":"EMA/760345/2015","document_url":"https://www.ema.europa.eu/en/documents/other/delivery-time-frame-eu-portal-and-eu-database_en.pdf"},
    {"id":"4096","name":"Standard operating procedure for CHMP / CAT / PRAC rapporteur / co-rapporteur / peer-reviewer appointment in the centralised procedure","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-06-18T02:00:00Z","last_updated_date":"2017-04-11T19:10:00Z","reference_number":"SOP/H/3143","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-chmp-cat-prac-rapporteur-co-rapporteur-peer-reviewer-appointment-centralised-procedure_en.pdf"},
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    {"id":"4098","name":"Opinion of the Committee on Herbal Medicinal Products on a Community herbal monograph on Cinnamomum verum J.S. Presl, cortex","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2011-08-05T02:00:00Z","reference_number":"EMA/HMPC/258018/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-cinnamomum-verum-js-presl-cortex_en.pdf"},
    {"id":"4099","name":"Superseded assessment report on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMEA/HMPC/251324/2006 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"4101","name":"Overview of comments received on 'Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products’ (EMA/CHMP/594085/2015)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-10-18T17:40:00Z","last_updated_date":"2016-10-18T17:40:00Z","reference_number":"EMA/242781/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-use-pharmacokinetics-and-pharmacodynamics-development-antimicrobial-medicinal-products-emachmp5940852015_en.pdf"},
    {"id":"4102","name":"Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Avastin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/CHMP/746208/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-avastin_sv.pdf"}},
    {"id":"4103","name":"Gamithromycin (all ruminants except bovine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T16:32:00Z","last_updated_date":"2017-01-10T16:32:00Z","reference_number":"EMA/CVMP/454092/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gamithromycin-all-ruminants-except-bovine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"4104","name":"Withdrawal assessment report for Pristiqs","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-06-27T02:00:00Z","last_updated_date":"2008-06-27T02:00:00Z","reference_number":"EMEA/207284/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-pristiqs_en.pdf"},
    {"id":"4106","name":"Ergot derivatives Article-31 referral - Dihydroergocryptine - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-ii_sv.pdf"}},
    {"id":"4107","name":"Presentation - \n\nRegulatory compliance in non-clinical development (Milton Bonelli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T18:12:00Z","last_updated_date":"2016-10-26T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-compliance-non-clinical-development-milton-bonelli_en.pdf"},
    {"id":"4108","name":"Guideline on medicinal gases: Pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-07-09T02:00:00Z","last_updated_date":"2008-07-09T02:00:00Z","reference_number":"CPMP/QWP/1719/00 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-medicinal-gases-pharmaceutical-documentation-including-recommendation-non-clinical-safety-requirements-well-established-medicinal-gases-revision-1_en.pdf"},
    {"id":"4109","name":"Presentation - Veterinarians experiences: Other species - Horses (C.Scicluna)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinarians-experiences-other-species-horses-cscicluna_en.pdf"},
    {"id":"4110","name":"Augmentin - Article 30 - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/augmentin-article-30-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/augmentin-article-30-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/augmentin-article-30-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/augmentin-article-30-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/augmentin-article-30-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/augmentin-article-30-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/augmentin-article-30-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/augmentin-article-30-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/augmentin-article-30-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/augmentin-article-30-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/augmentin-article-30-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/augmentin-article-30-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/augmentin-article-30-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/augmentin-article-30-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/augmentin-article-30-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/augmentin-article-30-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/augmentin-article-30-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/augmentin-article-30-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/augmentin-article-30-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/augmentin-article-30-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/augmentin-article-30-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/augmentin-article-30-annex-iii_sv.pdf"}},
    {"id":"4112","name":"Inventory of paediatric therapeutic needs - Infectious diseases","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-05-08T11:30:00Z","last_updated_date":"2014-05-08T11:30:00Z","reference_number":"EMA/PDCO/287222/2012","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-therapeutic-needs-infectious-diseases_en.pdf"},
    {"id":"4114","name":"EU/3/05/284: Public summary of positive opinion for orphan designation of sodium butyrate (rectal use) for the prevention of radiation proctitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-06-29T02:00:00Z","last_updated_date":"2005-06-29T02:00:00Z","reference_number":"EMEA/COMP/140439/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305284-public-summary-positive-opinion-orphan-designation-sodium-butyrate-rectal-use-prevention-radiation-proctitis_en.pdf"},
    {"id":"4117","name":"CHMP summary of positive opinion for Pioglitazone Actavis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/CHMP/508725/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pioglitazone-actavis_en.pdf"},
    {"id":"4118","name":"Presentation - An oncology systems pharmacology approach to dose selection (James Yates)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-oncology-systems-pharmacology-approach-dose-selection-james-yates_en.pdf"},
    {"id":"4119","name":"Overview of comments received on 'Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus’ (EMA/CVMP/IWP/205351/2006-Rev.1)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-09-17T18:35:01Z","last_updated_date":"2015-09-17T18:35:01Z","reference_number":"EMA/CVMP/IWP/342158/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-procedure-be-followed-when-batch-vaccine-finished-product-suspected-be-contaminated-bovine-viral-diarrhoea-virus-emacvmpiwp2053512006-rev1_en.pdf"},
    {"id":"4122","name":"Pathogen specific database: Botulism","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-botulism_en.pdf"},
    {"id":"4123","name":"Draft list of references supporting the assessment of Levisticum officinale Koch, radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2012-05-03T15:41:00Z","last_updated_date":"2012-05-03T15:41:00Z","reference_number":"EMA/HMPC/524626/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-levisticum-officinale-koch-radix_en.pdf"},
    {"id":"4126","name":"Draft CHMP guideline on clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/EWP/356954/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-chmp-guideline-clinical-investigations-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"4127","name":"Questions and answers on the recommendation for the refusal of the marketing authorisation for Milnacipran Pierre Fabre Médicament / Impulsor","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-11-20T01:00:00Z","last_updated_date":"2009-11-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-milnacipran-pierre-fabre-medicament-impulsor_sv.pdf"}},
    {"id":"4130","name":"Results of the sampling and testing programme for the year 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-12-18T12:40:00Z","last_updated_date":"2013-12-18T12:40:00Z","reference_number":"EMA/INS/S&T/613387/2013","document_url":"https://www.ema.europa.eu/en/documents/report/results-sampling-and-testing-programme-year-2012_en.pdf"},
    {"id":"4131","name":"COMP meeting report on the review of applications for orphan designation: November 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-11-14T15:35:00Z","last_updated_date":"2016-11-14T15:35:00Z","reference_number":"EMA/COMP/676785/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-november-2016_en.pdf"},
    {"id":"4132","name":"Overview of comments received on draft guideline on multiple sclerosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-11-16T01:00:00Z","last_updated_date":"2006-11-16T01:00:00Z","reference_number":"CHMP/EWP/438043/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-multiple-sclerosis_en.pdf"},
    {"id":"4134","name":"CHMP summary of positive opinion for Kymriah","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T14:00:00Z","last_updated_date":"2018-06-29T14:00:00Z","reference_number":"EMA/CHMP/289459/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kymriah_en.pdf"},
    {"id":"4137","name":"EU/3/16/1700: Public summary of opinion on orphan designation: Mifamurtide for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/449076/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161700-public-summary-opinion-orphan-designation-mifamurtide-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"4139","name":"Presentation - Topic 2 - Trial design considerations for evaluation of new treatment regimens, an academic perspective (Andrew Nunn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-2-trial-design-considerations-evaluation-new-treatment-regimens-academic-perspective-andrew-nunn_en.pdf"},
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    {"id":"4162","name":"EU/3/00/014: Iloprost for the treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug-induced pulmonary hypertension, portopulmonary hyp...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T00:00:00Z","last_updated_date":"2013-10-08T15:00:00Z","reference_number":"EMEA/COMP/617901/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300014-iloprost-treatment-primary-and-following-forms-secondary-pulmonary-hypertension-connective-tissue-disease-pulmonary-hypertension-drug-induced-pulmonary-hypertension-portopulmonary-hyp_en.pdf"},
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    {"id":"4180","name":"Withdrawal assessment report for DuoPlavin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-31T02:00:00Z","last_updated_date":"2010-03-31T02:00:00Z","reference_number":"EMEA/CHMP/272324/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-duoplavin_en.pdf"},
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    {"id":"4187","name":"Jobs @EMA User guide","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T13:10:00Z","last_updated_date":"2018-04-18T14:00:00Z","reference_number":"EMA/847592/2017","document_url":"https://www.ema.europa.eu/en/documents/other/jobs-ema-user-guide_en.pdf"},
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    {"id":"4193","name":"Public statement on Intanza: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-09-04T13:36:00Z","last_updated_date":"2018-09-04T13:36:00Z","reference_number":"EMA/567363/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-intanza-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"4213","name":"Committee for Proprietary Medicinal Products (CPMP) 53rd plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-10-25T02:00:00Z","last_updated_date":"1999-10-25T02:00:00Z","reference_number":"CPMP/2769/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-53rd-plenary-meeting_en.pdf"},
    {"id":"4218","name":"Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs Article-35 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-05T13:00:00Z","last_updated_date":"2014-09-05T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/veterinary-medicinal-products-containing-tylosin-be-administered-orally-feed-or-drinking-water-pigs-article-35-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"4219","name":"EU GMP Requirements - Validation - Bernd Boedecker","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-20T02:09:21Z","last_updated_date":"2009-10-20T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-gmp-requirements-validation-bernd-boedecker_en.pdf"},
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    {"id":"4304","name":"Presentation - Update on pharmacovigilance legislation (Helen Lee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-pharmacovigilance-legislation-helen-lee_en.pdf"},
    {"id":"4307","name":"Presentation - The Adaptive Pathways pilot: complementing the EMA early access tools (Francesca Cerreta)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adaptive-pathways-pilot-complementing-ema-early-access-tools-francesca-cerreta_en.pdf"},
    {"id":"4309","name":"Questions and answers on the recommendation to suspend the marketing authorisation for Raptiva","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-02-19T00:09:21Z","last_updated_date":"2009-02-19T00:09:21Z","reference_number":"EMEA/CHMP/15525/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-suspend-marketing-authorisation-raptiva_en.pdf"},
    {"id":"4310","name":"Final opinion of the HMPC on a Community herbal monograph on Solanum dulcamara L., stipites","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2013-02-15T01:00:00Z","reference_number":"EMA/HMPC/26000/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-community-herbal-monograph-solanum-dulcamara-l-stipites_en.pdf"},
    {"id":"4311","name":"Final list of references supporting the assessment Symphytum officinale L., radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-06-05T02:00:00Z","last_updated_date":"2015-06-05T02:00:00Z","reference_number":"EMA/HMPC/572845/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-symphytum-officinale-l-radix_en.pdf"},
    {"id":"4315","name":"Overview of comments received on draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - First version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-10-18T02:00:00Z","last_updated_date":"2006-10-18T02:00:00Z","reference_number":"EMEA/CHMP/EWP/392476/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis-first-version_en.pdf"},
    {"id":"4317","name":"Porcilis PRRS - Article 6(12) referral - Annexes I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-08-18T02:00:00Z","last_updated_date":"2010-08-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/porcilis-prrs-article-612-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"4318","name":"VICH GL50 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-06-27T18:00:00Z","last_updated_date":"2017-06-27T18:00:00Z","reference_number":"VICH/12/056","document_url":"https://www.ema.europa.eu/en/documents/comments/vich-gl50-overview-comments-harmonization-criteria-waive-target-animal-batch-safety-testing-inactivated-vaccines-veterinary-use_en.pdf"},
    {"id":"4320","name":"Diclazuril (Extension to all ruminants and porcine species): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-05-01T02:00:00Z","last_updated_date":"2004-05-01T02:00:00Z","reference_number":"EMEA/MRL/895/04-Final-rev","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diclazuril-extension-all-ruminants-and-porcine-species-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4322","name":"Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-08T01:00:00Z","last_updated_date":"2016-10-18T12:21:20Z","reference_number":"EMA/178486/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gastrointestinal-indication-list-nationally-authorised-medicinal-products-psusa00010291201506_en.pdf"},
    {"id":"4324","name":"Pilocarpine (ophthalmic formulation): List of nationally authorised medicinal products - PSUSA/00002410/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T16:00:00Z","last_updated_date":"2017-05-12T16:00:00Z","reference_number":"EMA/288255/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/pilocarpine-ophthalmic-formulation-list-nationally-authorised-medicinal-products-psusa00002410201608_en.pdf"},
    {"id":"4325","name":"Final list of references supporting the assessment of Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T13:00:00Z","last_updated_date":"2015-04-09T13:00:00Z","reference_number":"EMA/HMPC/320929/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-andor-other-species-melaleuca-aetheroleum-first-version_en.pdf"},
    {"id":"4326","name":"Amitraz (Extrapolation to goats): Summary report (4) Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/MRL/872/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/amitraz-extrapolation-goats-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4327","name":"European Medicines Agency reviews hypothesis on\n\nPandemrix and development of narcolepsy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-10-19T13:00:00Z","last_updated_date":"2012-10-19T13:00:00Z","reference_number":"EMA/CHMP/676755/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-reviews-hypothesis-pandemrix-and-development-narcolepsy_en.pdf"},
    {"id":"4331","name":"Codeine Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-08-02T02:00:00Z","last_updated_date":"2013-08-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"4334","name":"EU/3/11/946: Public summary of positive opinion for orphan designation: Recombinant homodimer of the human annexin V for the prevention of ischaemia/reperfusion injury associated with solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2014-04-01T18:00:00Z","reference_number":"EMA/COMP/923118/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311946-public-summary-positive-opinion-orphan-designation-recombinant-homodimer-human-annexin-v-prevention-ischaemiareperfusion-injury-associated-solid-organ-transplantation_en.pdf"},
    {"id":"4337","name":"Hydroxyethyl starch Article-107i procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-review-started_en.pdf"},
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    {"id":"4391","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured human olfactory ensheathing cells and olfactory nerve fibroblasts","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-08-23T17:00:00Z","last_updated_date":"2018-08-23T17:00:00Z","reference_number":"EMA/496382/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-human-olfactory-ensheathing-cells-and-olfactory-nerve-fibroblasts_en.pdf"},
    {"id":"4393","name":"Presentation - European Medicines Agency survey on post-authorisation procedures (Marie-Hà©là¨ne Pinheiro, Alberto Ganan-Jimenez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T14:00:01Z","last_updated_date":"2015-11-12T14:00:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-survey-post-authorisation-procedures-marie-haclane-pinheiro-alberto-ganan-jimenez_en.pdf"},
    {"id":"4395","name":"Superseded overview of comments received on 'Community herbal monograph on Equisetum arvense L., herba' (EMEA/HMPC/394894/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2016-03-17T01:09:21Z","reference_number":"EMEA/HMPC/230479/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-equisetum-arvense-l-herba-emeahmpc3948942007_en.pdf"},
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    {"id":"4398","name":"Presentation - Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (MLM Service)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-medical-literature-and-entry-relevant-information-eudravigilance-database-european-medicines-agency-mlm-service_en.pdf"},
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    {"id":"4401","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Brian Ager","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-brian-ager_en.pdf"},
    {"id":"4403","name":"Guidelines and concept papers adopted during the CHMP meeting 12-15 March 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T20:03:27Z","last_updated_date":"2012-03-16T20:03:27Z","reference_number":"EMA/CHMP/162992/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-12-15-march-2012_en.pdf"},
    {"id":"4406","name":"Agenda - Orphan medicines development in Europe and Japan","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-10-17T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"EMA/551226/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-orphan-medicines-development-europe-and-japan_en.pdf"},
    {"id":"4407","name":"EU/3/02/107: Public summary of positive opinion for orphan designation of purified bromelain for the treatment of partial deep dermal and full thickness burns","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-08T00:00:00Z","last_updated_date":"2023-02-15T14:00:00Z","reference_number":"EMEA/COMP/1413/02 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302107-public-summary-positive-opinion-orphan-designation-purified-bromelain-treatment-partial-deep-dermal-and-full-thickness-burns_en.pdf"},
    {"id":"4410","name":"Presentation - Objectives of the training session for patients and consumers involved in EMA activities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-training-session-patients-and-consumers-involved-ema-activities_en.pdf"},
    {"id":"4411","name":"Committee for Medicinal Products for Human Use post-authorisation summary of positive opinion for Avaglim on 24 January 2008","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T00:09:21Z","last_updated_date":"2008-01-24T00:09:21Z","reference_number":"EMEA/CHMP/42762/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/committee-medicinal-products-human-use-post-authorisation-summary-positive-opinion-avaglim-24-january-2008_en.pdf"},
    {"id":"4413","name":"The bacterial challenge: Time to react","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-09-01T02:00:00Z","last_updated_date":"2009-09-01T02:00:00Z","reference_number":"EMEA/576176/2009","document_url":"https://www.ema.europa.eu/en/documents/report/bacterial-challenge-time-react_en.pdf"},
    {"id":"4416","name":"Ampicillin / sulbactam: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000197/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-30T01:00:00Z","last_updated_date":"2016-10-17T19:40:13Z","reference_number":"EMA/801362/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/ampicillin-sulbactam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000197201502_en.pdf"},
    {"id":"4419","name":"Annual report of the European Agency for the Evaluation of Medicinal Products 2002","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2002-12-19T00:09:21Z","last_updated_date":"2002-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_es.pdf","da":"https://www.ema.europa.eu/da/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_da.pdf","de":"https://www.ema.europa.eu/de/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_de.pdf","el":"https://www.ema.europa.eu/el/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_fr.pdf","it":"https://www.ema.europa.eu/it/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2002_sv.pdf"}},
    {"id":"4420","name":"EU Telematics systems in operation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T14:30:00Z","last_updated_date":"2017-10-30T10:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/eu-telematics-systems-operation_en.pdf"},
    {"id":"4421","name":"Significant benefit of orphan drugs: concepts and future developments","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2012-07-25T15:35:00Z","last_updated_date":"2012-07-25T15:35:00Z","reference_number":"EMA/326061/2012","document_url":"https://www.ema.europa.eu/en/documents/report/significant-benefit-orphan-drugs-concepts-and-future-developments_en.pdf"},
    {"id":"4422","name":"Presentation - Our first experience with a European Medicines Agency adaptive licensing pilot project (Fabrizia Bignami)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-our-first-experience-european-medicines-agency-adaptive-licensing-pilot-project-fabrizia-bignami_en.pdf"},
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    {"id":"4427","name":"PRAC strategy on measuring the impact of pharmacovigilance activities","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2022-04-19T10:03:00Z","last_updated_date":"2022-04-19T10:03:00Z","reference_number":"EMA/590673/2020 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/other/prac-strategy-measuring-impact-pharmacovigilance-activities_en.pdf"},
    {"id":"4428","name":"Incorporating patients' views during evaluation of benefit-risk by the European Medicines Agency scientific committees","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T12:00:00Z","last_updated_date":"2014-10-24T14:00:00Z","reference_number":"EMA/413422/2013 Rev1","document_url":"https://www.ema.europa.eu/en/documents/other/incorporating-patients-views-during-evaluation-benefit-risk-european-medicines-agency-scientific-committees_en.pdf"},
    {"id":"4431","name":"CHMP summary of positive opinion for Hizentra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-02-18T01:00:00Z","last_updated_date":"2011-02-18T01:00:00Z","reference_number":"EMA/CHMP/110226/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hizentra_en.pdf"},
    {"id":"4432","name":"Topotecan: List of nationally authorised medicinal products - PSUSA/00002997/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-22T13:00:00Z","last_updated_date":"2016-10-17T20:16:40Z","reference_number":"EMA/52102/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/topotecan-list-nationally-authorised-medicinal-products-psusa00002997201505_en.pdf"},
    {"id":"4433","name":"Bromocriptine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-06T02:00:00Z","last_updated_date":"2013-09-06T02:00:00Z","reference_number":"EMA/541119/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-annex-i_en.pdf"},
    {"id":"4434","name":"CHMP summary of positive opinion for Rivastigmine 1 A Pharma","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rivastigmine-1-pharma_en.pdf"},
    {"id":"4436","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - October 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-10-31T01:00:00Z","last_updated_date":"2008-10-31T01:00:00Z","reference_number":"EMEA/625759/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-october-2008_en.pdf"},
    {"id":"4438","name":"Presentation - Proposal for communicating on measures to prevent medication errors (Inga Abed)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-communicating-measures-prevent-medication-errors-inga-abed_en.pdf"},
    {"id":"4439","name":"Agenda and registration form - EudraVigilance information day: 21 June 2016","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T12:40:00Z","last_updated_date":"2016-06-07T11:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-information-day-21-june-2016_en.pdf"},
    {"id":"4441","name":"Multiannual work programme 2018-2020","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2018-03-19T11:30:00Z","last_updated_date":"2018-03-19T11:30:00Z","reference_number":"EMA/73199/2018","document_url":"https://www.ema.europa.eu/en/documents/work-programme/multiannual-work-programme-2018-2020_en.pdf"},
    {"id":"4442","name":"Public summary of positive opinion for orphan designation of trabedersen for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-11T02:00:00Z","last_updated_date":"2014-04-03T16:00:00Z","reference_number":"EMEA/COMP/373187/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-positive-opinion-orphan-designation-trabedersen-treatment-pancreatic-cancer_en.pdf"},
    {"id":"4445","name":"Minutes of the European network of paediatric research and the European Medicines Agency Coordinating Group (Enpr-EMA CG) teleconference meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T16:45:00Z","last_updated_date":"2015-12-08T16:45:00Z","reference_number":"EMA/701987/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-and-european-medicines-agency-coordinating-group-enpr-ema-cg-teleconference-meeting_en.pdf"},
    {"id":"4450","name":"Organisational matters - CHMP meeting 23-26 June 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-01T16:30:00Z","last_updated_date":"2014-07-01T16:30:00Z","reference_number":"EMA/125354/2014","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-23-26-june-2014_en.pdf"},
    {"id":"4451","name":"EudraVigilance Form B","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2023-01-20T09:15:00Z","reference_number":"EMA/99667/2016","document_url":"https://www.ema.europa.eu/en/documents/template-form/eudravigilance-form-b_en.docx"},
    {"id":"4452","name":"Work plan of the CHMP Blood Products Working Party for 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2016-03-08T11:00:00Z","last_updated_date":"2018-01-18T16:37:00Z","reference_number":"EMA/CHMP/BPWP/399637/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-chmp-blood-products-working-party-2018_en.pdf"},
    {"id":"4453","name":"Presentation -  Patients’ views on the products selected for the adaptive pathways pilot (Rafal Swierzewski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-views-products-selected-adaptive-pathways-pilot-rafal-swierzewski_en.pdf"},
    {"id":"4454","name":"CHMP summary of positive opinion for Zoledronic acid Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T13:00:00Z","last_updated_date":"2012-03-16T13:00:00Z","reference_number":"EMA/186863/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zoledronic-acid-teva_en.pdf"},
    {"id":"4455","name":"EU/3/09/692: Public summary of positive opinion for orphan designation of\n\n16-base single-stranded PNA oligonucleotide linked to a 7-aminoacid peptide for the treatment of neuroblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2014-04-01T18:00:00Z","reference_number":"EMA/COMP/654094/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309692-public-summary-positive-opinion-orphan-designation-16-base-single-stranded-pna-oligonucleotide-linked-7-aminoacid-peptide-treatment-neuroblastoma_en.pdf"},
    {"id":"4457","name":"Presentation - Clinical and regulatory challenges in the development of CAR-modified and TCR-modified T-cells in the EU (Martina Schà¼àŸler-Lenz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-and-regulatory-challenges-development-car-modified-and-tcr-modified-t-cells-eu-martina-scha-14ayler-lenz_en.pdf"},
    {"id":"4459","name":"European Medicines Agency welcomes new Head of Information and Communications Technology","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T13:00:00Z","last_updated_date":"2012-02-16T13:00:00Z","reference_number":"EMA/119267/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-welcomes-new-head-information-and-communications-technology_en.pdf"},
    {"id":"4460","name":"Biennial report of the joint CVMP/CHMP working group on the application of the 3Rs in regulatory testing of medical products (2016/2017)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-02-26T15:00:00Z","last_updated_date":"2018-02-26T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/biennial-report-joint-cvmpchmp-working-group-application-3rs-regulatory-testing-medical-products-20162017_en.pdf"},
    {"id":"4461","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n16-18 October 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-10-19T02:09:21Z","last_updated_date":"2006-10-19T02:09:21Z","reference_number":"EMEA/421027/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-16-18-october-2006_en.pdf"},
    {"id":"4463","name":"Glipizide: List of nationally authorised medicinal products - PSUSA/00001535/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-05T02:00:00Z","last_updated_date":"2016-10-17T15:38:43Z","reference_number":"EMA/639604/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/glipizide-list-nationally-authorised-medicinal-products-psusa00001535201601_en.pdf"},
    {"id":"4465","name":"CHMP post-authorisation summary of positive opinion for Pradaxa","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"EMA/804086/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pradaxa_en.pdf"},
    {"id":"4466","name":"Minutes - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T17:30:00Z","last_updated_date":"2018-05-02T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-industry-stakeholder-meeting-brexit-and-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"4470","name":"Pandemic report and lessons learned: Outcome of the European Medicines Agency's activities during the 2009 (H1N1) flu pandemic","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-04-29T13:58:38Z","last_updated_date":"2011-04-29T13:58:38Z","reference_number":"EMA/221017/2011","document_url":"https://www.ema.europa.eu/en/documents/report/pandemic-report-and-lessons-learned-outcome-european-medicines-agencys-activities-during-2009-h1n1-flu-pandemic_en.pdf"},
    {"id":"4471","name":"Guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CVMP/516817/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-be-provided-support-request-include-substance-list-substances-considered-not-falling-within-scope-regulation-ec-no-4702009_en.pdf"},
    {"id":"4472","name":"Levocabastine: List of nationally authorised medicinal products - PSUSA/00001849/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T16:45:00Z","last_updated_date":"2018-07-19T16:45:00Z","reference_number":"EMA/498812/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/levocabastine-list-nationally-authorised-medicinal-products-psusa00001849201711_en.pdf"},
    {"id":"4473","name":"Guidelines for the conduct of pharmacokinetic studies in target animal species","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-03-08T01:00:00Z","last_updated_date":"2000-03-08T01:00:00Z","reference_number":"EMEA/CVMP/133/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-conduct-pharmacokinetic-studies-target-animal-species_en.pdf"},
    {"id":"4474","name":"Presentation - Spectrum of market-research programmes: Type of safety data collected","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T02:00:00Z","last_updated_date":"2013-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spectrum-market-research-programmes-type-safety-data-collected_en.pdf"},
    {"id":"4476","name":"Questions and answers on the withdrawal of the marketing application for\n\nTheraloc","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"EMEA/651597/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-theraloc_sv.pdf"}},
    {"id":"4478","name":"Questions and answers on Neupro (rotigotine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-06-18T02:00:00Z","last_updated_date":"2008-06-18T02:00:00Z","reference_number":"EMEA/265069/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-neupro-rotigotine_en.pdf"},
    {"id":"4480","name":"Presentation - European strategy for SMEs in the pharmaceutical legislation: Directorate General for Health and Consumers (Andrzej Rys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-strategy-smes-pharmaceutical-legislation-directorate-general-health-and-consumers-andrzej-rys_en.pdf"},
    {"id":"4481","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 March 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/CVMP/154373/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-march-2011_en.pdf"},
    {"id":"4483","name":"Cardioxane Article 13 referral - Questions and answers on Cardioxane (dexrazoxane, powder for solution for injection, 500 mg)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/184071/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cardioxane-article-13-referral-questions-and-answers-cardioxane-dexrazoxane-powder-solution-injection-500-mg_sv.pdf"}},
    {"id":"4484","name":"Committee for veterinary medicinal products: 62nd meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-01-11T12:09:21Z","last_updated_date":"2001-01-11T12:09:21Z","reference_number":"EMEA/CVMP/064/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-62nd-meeting_en.pdf"},
    {"id":"4486","name":"EMA Management Board: highlights of June 2015 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-06-12T02:00:00Z","last_updated_date":"2015-06-12T02:00:00Z","reference_number":"EMA/392044/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-june-2015-meeting_en.pdf"},
    {"id":"4488","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 29-30 January 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-02-19T14:40:00Z","last_updated_date":"2018-03-02T15:32:00Z","reference_number":"EMA/HMPC/74171/2018 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-29-30-january-2018_en.pdf"},
    {"id":"4490","name":"Sodium cetostearyl sulphate: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:09:21Z","last_updated_date":"1998-06-01T02:09:21Z","reference_number":"EMEA/MRL/449/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sodium-cetostearyl-sulphate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4491","name":"Draft list of references supporting the assessment of Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2015-04-09T02:00:00Z","reference_number":"EMA/HMPC/712512/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-epilobium-angustifolium-l-andor-epilobium-parviflorum-schreb-herba_en.pdf"},
    {"id":"4496","name":"Management Board finalises its long-term plan and adopts work programme and budget for 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-12-17T00:09:21Z","last_updated_date":"2004-12-17T00:09:21Z","reference_number":"EMEA/204096/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/management-board-finalises-its-long-term-plan-and-adopts-work-programme-and-budget-2005_en.pdf"},
    {"id":"4497","name":"CHMP summary of positive opinion for Vitekta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/CHMP/5643227/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vitekta_en.pdf"},
    {"id":"4498","name":"EU/3/16/1634: Public summary of opinion on orphan designation: Glucopyranosyl lipid A stable emulsion and recombinant New York oesophageal squamous cell carcinoma-1 protein for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2019-10-15T02:00:00Z","reference_number":"EMA/COMP/159769/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161634-public-summary-opinion-orphan-designation-glucopyranosyl-lipid-stable-emulsion-and-recombinant-new-york-oesophageal-squamous-cell-carcinoma-1-protein-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"4501","name":"Opinion of the CVMP on the establishment of maximum residue limits: Monepantel","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-03-22T01:00:00Z","last_updated_date":"2012-03-22T01:00:00Z","reference_number":"EMA/CVMP/165867/2011-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-monepantel_en.pdf"},
    {"id":"4502","name":"Linear alkyl benzene sulphonic acids: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/755/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/linear-alkyl-benzene-sulphonic-acids-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4504","name":"Highlights from the European Medicines Agency industry platform meeting held on 21 April 2016 on the operation of the centralised procedure for human medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-09-02T16:00:00Z","last_updated_date":"2016-09-02T16:00:00Z","reference_number":"EMA/526723/2016","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-european-medicines-agency-industry-platform-meeting-held-21-april-2016-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"4506","name":"Feedback form - Focus group on promotion of pharmacovigilance for food producing animals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/feedback-form-focus-group-promotion-pharmacovigilance-food-producing-animals_en.pdf"},
    {"id":"4507","name":"CHMP summary of positive opinion for Ibandronic acid Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/513131/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ibandronic-acid-accord_en.pdf"},
    {"id":"4508","name":"EU/3/07/501: Public summary of positive opinion for orphan designation of olaparib for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2018-05-28T17:00:00Z","reference_number":"EMEA/COMP/510787/2007 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307501-public-summary-positive-opinion-orphan-designation-olaparib-treatment-ovarian-cancer_en.pdf"},
    {"id":"4510","name":"Presentation - Early paediatric interaction meeting: initial consultation on paediatric development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T17:00:00Z","last_updated_date":"2016-05-27T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-paediatric-interaction-meeting-initial-consultation-paediatric-development_en.pdf"},
    {"id":"4511","name":"Mandate, objectives and rules of procedure for the CHMP PG Working Party","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2009-06-25T02:09:21Z","reference_number":"EMEA/CHMP/125959/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-chmp-pg-working-party_en.pdf"},
    {"id":"4513","name":"CHMP post-authorisation positive summary of opinion for Pradaxa","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-07-20T02:00:00Z","last_updated_date":"2012-07-20T02:00:00Z","reference_number":"EMA/337034/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-positive-summary-opinion-pradaxa_en.pdf"},
    {"id":"4514","name":"Committee for Advanced Therapies (CAT) elects chair and vice-chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T01:00:00Z","last_updated_date":"2009-02-16T01:00:00Z","reference_number":"EMEA/85845/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-advanced-therapies-cat-elects-chair-and-vice-chair_en.pdf"},
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    {"id":"4518","name":"Declaration of interests: Sylvie Benefice","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:13Z","last_updated_date":"2015-09-01T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-sylvie-benefice_en.pdf"},
    {"id":"4519","name":"EU/3/17/1884: Public summary of opinion on orphan designation: Recombinant human factor IX protein modified with three point mutations for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/COMP/336095/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171884-public-summary-opinion-orphan-designation-recombinant-human-factor-ix-protein-modified-three-point-mutations-treatment-haemophilia-b_en.pdf"},
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    {"id":"4531","name":"EU wide recall of Raptiva efalizumab to be initiated","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-08T02:00:00Z","last_updated_date":"2009-06-08T02:00:00Z","reference_number":"EMEA/346255/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-wide-recall-raptiva-efalizumab-be-initiated_en.pdf"},
    {"id":"4532","name":"Presentation - Activities related to the use of antimicrobials in animals - Session 2 (Jordi Torren Edo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-activities-related-use-antimicrobials-animals-session-2-jordi-torren-edo_en.pdf"},
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    {"id":"4540","name":"Opinions on safety variations adopted at the CHMP meeting 10-13 December 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-18T17:30:01Z","last_updated_date":"2012-12-18T17:30:01Z","reference_number":"EMA/CHMP/732292/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-chmp-meeting-10-13-december-2012_en.pdf"},
    {"id":"4545","name":"Opinion of the CVMP on the establishment of maximum residue limits: Tildipirosin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-04-14T15:30:00Z","last_updated_date":"2014-04-14T15:30:00Z","reference_number":"EMA/CVMP/440151/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-tildipirosin_en.pdf"},
    {"id":"4546","name":"Presentation - Subgroup analyses: from nasty business to stratified medicine – an HTA perspective (Lange)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subgroup-analyses-nasty-business-stratified-medicine-hta-perspective-lange_en.pdf"},
    {"id":"4547","name":"Malic acid: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-18T01:00:00Z","last_updated_date":"1997-02-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/malic-acid-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4550","name":"Final Community herbal monograph on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-10-06T02:00:00Z","last_updated_date":"2014-10-06T02:00:00Z","reference_number":"EMA/HMPC/680618/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
    {"id":"4552","name":"EU/3/07/472: Public summary of positive opinion for orphan designation of cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobutyryl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"EMEA/COMP/167445/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307472-public-summary-positive-opinion-orphan-designation-cyclo-ez-2s3r4r-3-hydroxy-4-methyl-2-methylaminonona-68-dienoyl-l-2-aminobutyryl-n-methyl-glycyl-n-methyl-l-leucyl-l-valyl-n-methyl-l_en.pdf"},
    {"id":"4553","name":"Registration form: First anniversary of PRIME: experience so far","type":"template-form","status":"Draft","consultation_date":"","first_published_date":"2017-03-22T15:00:00Z","last_updated_date":"2017-03-22T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-first-anniversary-prime-experience-so-far_en.pdf"},
    {"id":"4561","name":"Internal control standards and underlying framework: strengthening control effectiveness","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/MB/602884/2015","document_url":"https://www.ema.europa.eu/en/documents/other/internal-control-standards-and-underlying-framework-strengthening-control-effectiveness_en.pdf"},
    {"id":"4563","name":"Public bulletin: Veterinary pharmacovigilance 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-28T15:30:00Z","last_updated_date":"2013-02-28T15:30:00Z","reference_number":"EMA/CVMP/PhVWP/717241/2012","document_url":"https://www.ema.europa.eu/en/documents/other/public-bulletin-veterinary-pharmacovigilance-2012_en.pdf"},
    {"id":"4564","name":"ICH: M 4: Common technical document for the registration of pharmaceuticals for human use - Questions and answers - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"CPMP/ICH/5552/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-4-common-technical-document-registration-pharmaceuticals-human-use-questions-and-answers-step-5_en.pdf"},
    {"id":"4566","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:45:00Z","last_updated_date":"2017-02-28T14:45:00Z","reference_number":"EMA/127201/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-epstein-barr-virus-cytotoxic-t-lymphocytes_en.pdf"},
    {"id":"4567","name":"Botulinum toxin a - haemagglutinin complex: CMDh scientific conclusions and grounds for the variation, amendments to the product information, conditions to the MA and timetable for the implementation - PSUSA/00000427/201...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-25T02:00:00Z","last_updated_date":"2016-10-25T19:31:49Z","reference_number":"EMA/706150/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/botulinum-toxin-haemagglutinin-complex-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-conditions-ma-and-timetable-implementation-psusa00000427201_en.pdf"},
    {"id":"4569","name":"Pandemic pharmacovigilance weekly update (status at 27 November 2009)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-12-03T00:09:21Z","last_updated_date":"2009-12-03T00:09:21Z","reference_number":"EMEA/784681/2009","document_url":"https://www.ema.europa.eu/en/documents/report/pandemic-pharmacovigilance-weekly-update-status-27-november-2009_en.pdf"},
    {"id":"4572","name":"Download EPS - Species pictograms - Chicken","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-chicken_en.zip"},
    {"id":"4573","name":"Presentation - PDCO perspectives and proposals: Enpr-EMA coordinating group","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T16:02:00Z","last_updated_date":"2018-06-18T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-perspectives-and-proposals-enpr-ema-coordinating-group_en.pdf"},
    {"id":"4574","name":"Maci Article-20 procedure - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-12-17T01:00:00Z","last_updated_date":"2014-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/maci-article-20-procedure-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/maci-article-20-procedure-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/maci-article-20-procedure-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/maci-article-20-procedure-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/maci-article-20-procedure-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/maci-article-20-procedure-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/maci-article-20-procedure-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/maci-article-20-procedure-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/maci-article-20-procedure-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/maci-article-20-procedure-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/maci-article-20-procedure-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/maci-article-20-procedure-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/maci-article-20-procedure-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/maci-article-20-procedure-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/maci-article-20-procedure-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/maci-article-20-procedure-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/maci-article-20-procedure-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/maci-article-20-procedure-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/maci-article-20-procedure-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/maci-article-20-procedure-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/maci-article-20-procedure-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/maci-article-20-procedure-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/maci-article-20-procedure-annex-ii_sv.pdf"}},
    {"id":"4575","name":"Questions and answers relating to restricted tender procedure no. EMA/2012/43/IS – Display-screen-equipment assessments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T15:30:00Z","last_updated_date":"2013-01-03T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-restricted-tender-procedure-no-ema201243is-display-screen-equipment-assessments_en.pdf"},
    {"id":"4577","name":"CVMP interested parties’ meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-04-20T17:50:00Z","last_updated_date":"2016-04-20T17:50:00Z","reference_number":"EMA/CVMP/47072/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/cvmp-interested-parties-meeting_en.pdf"},
    {"id":"4580","name":"Non-clinical documentation - Overview of Requirements - Jean-Marc Vidal","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/non-clinical-documentation-overview-requirements-jean-marc-vidal_en.pdf"},
    {"id":"4583","name":"Presentation - Objectives: EMA workshop on the collaboration with general practitioners/family physicians (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T02:00:00Z","last_updated_date":"2016-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-ema-workshop-collaboration-general-practitionersfamily-physicians-isabelle-moulon_en.pdf"},
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    {"id":"4611","name":"Final list of references supporting the assessment of Thymus vulgaris L., Thymus zygis Loefl. ex. L., aetheroleum - Superseded","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/HMPC/131905/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-thymus-vulgaris-l-thymus-zygis-loefl-ex-l-aetheroleum-superseded_en.pdf"},
    {"id":"4612","name":"EU/3/15/1527: Public summary of opinion on orphan designation: Hydrocinnamate-[Orn-Pro-dCha-Trp-Arg]acetate for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T02:00:00Z","last_updated_date":"2015-08-18T02:00:00Z","reference_number":"EMA/COMP/431631/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151527-public-summary-opinion-orphan-designation-hydrocinnamate-orn-pro-dcha-trp-argacetate-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
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    {"id":"4621","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-03-26T12:53:00Z","last_updated_date":"2018-03-26T12:53:00Z","reference_number":"EMA/51903/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-february-2018_en.pdf"},
    {"id":"4622","name":"EU/3/08/530: Public summary of positive opinion for orphan designation of heterologous human adult liver derived stem cells for the treatment of ornithine-transcarbamylase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/2482/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308530-public-summary-positive-opinion-orphan-designation-heterologous-human-adult-liver-derived-stem-cells-treatment-ornithine-transcarbamylase-deficiency_en.pdf"},
    {"id":"4623","name":"Overview of comments received on community herbal monograph on Leonurus cardiaca L., herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/HMPC/561942/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-leonurus-cardiaca-l-herba_en.pdf"},
    {"id":"4624","name":"European Medicines Agency recommends approval of fourth advanced therapy in Europe","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/394057/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-fourth-advanced-therapy-europe_en.pdf"},
    {"id":"4625","name":"Regulators perspective on 'Quality by Design': GMP/GDP Inspectors Working Group - David Cockburn","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-09-28T02:09:21Z","last_updated_date":"2009-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/regulators-perspective-quality-design-gmpgdp-inspectors-working-group-david-cockburn_en.pdf"},
    {"id":"4626","name":"Zanil Article-35 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-25T18:30:00Z","last_updated_date":"2017-10-25T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zanil-article-35-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zanil-article-35-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zanil-article-35-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zanil-article-35-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zanil-article-35-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zanil-article-35-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zanil-article-35-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zanil-article-35-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zanil-article-35-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zanil-article-35-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zanil-article-35-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zanil-article-35-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zanil-article-35-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zanil-article-35-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zanil-article-35-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zanil-article-35-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zanil-article-35-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zanil-article-35-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zanil-article-35-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zanil-article-35-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zanil-article-35-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zanil-article-35-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zanil-article-35-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"4628","name":"CHMP statistics: May 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T14:00:00Z","last_updated_date":"2016-05-27T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-may-2016_en.pdf"},
    {"id":"4629","name":"Problems with medicines for bees: current situation and future aspects, Wolfgang Ritter, National and International (OIE) Reference laboratory at CVUA Freiburg","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/problems-medicines-bees-current-situation-and-future-aspects-wolfgang-ritter-national-and-international-oie-reference-laboratory-cvua-freiburg_en.pdf"},
    {"id":"4630","name":"CHMP post-authorisation summary of positive opinion for Vepacel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-10-25T02:00:00Z","last_updated_date":"2013-10-25T02:00:00Z","reference_number":"EMA/CHMP/648050/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vepacel_en.pdf"},
    {"id":"4631","name":"Presentation - When can field trials contribute practically to understanding of efficacy (and when do they not)  (J.  Wood)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:16:00Z","last_updated_date":"2017-11-16T13:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-when-can-field-trials-contribute-practically-understanding-efficacy-and-when-do-they-not-j-wood_en.pdf"},
    {"id":"4632","name":"CPMP Working Party on Herbal Medicinal Products (HMPWP) work programme 2004-2005","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2003-11-27T12:09:21Z","last_updated_date":"2003-11-27T12:09:21Z","reference_number":"EMEA/CPMP/HMPWP/5885/03","document_url":"https://www.ema.europa.eu/en/documents/work-programme/cpmp-working-party-herbal-medicinal-products-hmpwp-work-programme-2004-2005_en.pdf"},
    {"id":"4633","name":"Final assessment report on Chamaemelum nobile (L.) All., flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T17:20:00Z","last_updated_date":"2012-01-20T17:20:00Z","reference_number":"EMA/HMPC/560906/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"4634","name":"Agenda - 10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-06-10T16:00:00Z","last_updated_date":"2016-06-28T16:00:00Z","reference_number":"EMA/392315/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-10th-anniversary-european-medicines-agencys-patients-and-consumers-working-party-pcwp_en.pdf"},
    {"id":"4637","name":"Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/00010299/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T17:08:00Z","last_updated_date":"2017-10-26T17:33:46Z","reference_number":"EMA/715528/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-prepared-cell-cultures-list-nationally-authorised-medicinal-products-psusa00010299201703_en.pdf"},
    {"id":"4638","name":"EU/3/12/999: Public summary of opinion on orphan designation: Letermovir for the treatment of cytomegalovirus disease in patients with impaired cell mediated immunity","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2013-06-19T14:00:00Z","reference_number":"EMA/COMP/416248/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312999-public-summary-opinion-orphan-designation-letermovir-treatment-cytomegalovirus-disease-patients-impaired-cell-mediated-immunity_en.pdf"},
    {"id":"4639","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 14-17 December 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-01-05T13:30:00Z","last_updated_date":"2016-01-05T13:30:00Z","reference_number":"EMA/38807/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-14-17-december-2015_en.pdf"},
    {"id":"4640","name":"Committee on herbal medicinal products (HMPC): Meeting report, 7-8 March 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-04-02T02:00:00Z","last_updated_date":"2007-04-02T02:00:00Z","reference_number":"EMEA/HMPC/138217/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-7-8-march-2007_en.pdf"},
    {"id":"4641","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Juvenile Scleroderma Working Group of the Pediatric Rheumatology European Society","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-juvenile-scleroderma-working-group-pediatric-rheumatology-european-society_en.pdf"},
    {"id":"4644","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Kyprolis (carfilzomib) for the treatment of multiple myeloma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-12-02T01:00:00Z","last_updated_date":"2015-12-02T01:00:00Z","reference_number":"EMA/COMP/656221/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-kyprolis-carfilzomib-treatment-multiple-myeloma_en.pdf"},
    {"id":"4646","name":"Overview of comments received on draft reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products (EMEA/HMPC/253629/2007)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/HMPC/297843/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-reflection-paper-markers-used-quantitative-and-qualitative-analysis-herbal-medicinal-products-and-traditional-herbal-medicinal-products-emeahmpc2536292007_en.pdf"},
    {"id":"4648","name":"CHMP summary of positive opinion for Mepsevii","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T14:00:00Z","last_updated_date":"2018-06-29T14:00:00Z","reference_number":"EMA/CHMP/383566/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mepsevii_en.pdf"},
    {"id":"4650","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 14-17 December 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T13:00:00Z","last_updated_date":"2015-12-18T13:00:00Z","reference_number":"EMA/CHMP/SAWP/857429/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-14-17-december-2015_en.pdf"},
    {"id":"4651","name":"Work plan for the joint CHMP/ CVMP Quality Working Party for 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-01-26T17:40:00Z","last_updated_date":"2017-12-21T11:30:00Z","reference_number":"EMA/CHMP/CVMP/QWP/504882/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-joint-chmp-cvmp-quality-working-party-2018_en.pdf"},
    {"id":"4652","name":"CHMP post-authorisation summary of positive opinion for Erbitux","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/702774/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-erbitux_en.pdf"},
    {"id":"4654","name":"Public statement on Daquiran: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2006-05-23T02:00:00Z","last_updated_date":"2006-05-23T02:00:00Z","reference_number":"EMEA/184565/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-daquiran-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"4655","name":"Work instructions for preparing notices for publication in Official Journal of the European Union (OJEU)","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2013-04-18T11:30:00Z","last_updated_date":"2013-04-18T11:30:00Z","reference_number":"WIN/EMA/0133","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-preparing-notices-publication-official-journal-european-union-ojeu_en.pdf"},
    {"id":"4656","name":"COMP meeting report on the review of applications for orphan designation: June 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T14:00:00Z","last_updated_date":"2013-06-20T14:00:00Z","reference_number":"EMA/COMP/318718/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-june-2013_en.pdf"},
    {"id":"4657","name":"Midodrine: List of nationally authorised medicinal products - PSUSA/00003178/201606","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-13T17:42:00Z","last_updated_date":"2017-02-13T17:44:02Z","reference_number":"EMA/106582/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/midodrine-list-nationally-authorised-medicinal-products-psusa00003178201606_en.pdf"},
    {"id":"4658","name":"CVMP post-authorisation summary of negative opinion for Draxxin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-05-20T02:00:00Z","reference_number":"EMA/CVMP/289817/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-negative-opinion-draxxin_en.pdf"},
    {"id":"4659","name":"Public statement on Clopidogrel BMS: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2010-01-27T00:09:21Z","last_updated_date":"2010-01-27T00:09:21Z","reference_number":"EMEA/784110/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-bms-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"4661","name":"EU/3/07/508: Public summary of positive opinion for orphan designation of chimeric-anti-interleukin 6 monoclonal antibody for the treatment of Castleman’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2014-07-11T14:02:00Z","reference_number":"EMEA/COMP/147287/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307508-public-summary-positive-opinion-orphan-designation-chimeric-anti-interleukin-6-monoclonal-antibody-treatment-castlemans-disease_en.pdf"},
    {"id":"4662","name":"Presentation - Impact of multiple active products on resistance development (Thomas Geurden)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-multiple-active-products-resistance-development-thomas-geurden_en.pdf"},
    {"id":"4664","name":"Agenda - CAT agenda of the 11–12 December 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-09T18:00:00Z","last_updated_date":"2015-01-09T18:00:00Z","reference_number":"EMA/CAT/652186/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-11-12-december-2014-meeting_en.pdf"},
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    {"id":"4715","name":"Thiocolchicoside Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-06T01:00:00Z","last_updated_date":"2014-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/thiocolchicoside-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/thiocolchicoside-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/thiocolchicoside-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/thiocolchicoside-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/thiocolchicoside-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/thiocolchicoside-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/thiocolchicoside-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/thiocolchicoside-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/thiocolchicoside-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/thiocolchicoside-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/thiocolchicoside-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/thiocolchicoside-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/thiocolchicoside-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/thiocolchicoside-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/thiocolchicoside-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/thiocolchicoside-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/thiocolchicoside-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/thiocolchicoside-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/thiocolchicoside-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/thiocolchicoside-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/thiocolchicoside-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/thiocolchicoside-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"4716","name":"Presentation - Session 1 – Documentation, resources and implementation  milestones","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-12T12:30:00Z","last_updated_date":"2016-05-12T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-documentation-resources-and-implementation-milestones_en.pdf"},
    {"id":"4720","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 13-15 December 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-12-16T01:00:00Z","last_updated_date":"2004-12-16T01:00:00Z","reference_number":"EMEA/199703/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-13-15-december-2004_en.pdf"},
    {"id":"4721","name":"Presentation - CAT’s views on classification of advanced-therapy medicinal products (Nicolas Ferry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T02:00:00Z","last_updated_date":"2014-10-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cats-views-classification-advanced-therapy-medicinal-products-nicolas-ferry_en.pdf"},
    {"id":"4722","name":"Presentation - European hub introduction and data set requirements (Paul Mills)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-14T02:00:00Z","last_updated_date":"2015-07-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-hub-introduction-and-data-set-requirements-paul-mills_en.pdf"},
    {"id":"4724","name":"Reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CVMP/SAGAM/741087/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-macrolides-lincosamides-and-streptogramins-mls-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"4726","name":"EU/3/00/013: Public summary of positive opinion for orphan designation of ethyl eicosopentaenoate for the treatment of Huntington's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T01:00:00Z","last_updated_date":"2006-01-04T01:00:00Z","reference_number":"EMEA/COMP/208510/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300013-public-summary-positive-opinion-orphan-designation-ethyl-eicosopentaenoate-treatment-huntingtons-disease_en.pdf"},
    {"id":"4727","name":"Agenda - Patients’ and Consumers’ Working Party and Healthcare Professionals Working Party joint meeting - September 2013","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-09-24T18:45:00Z","last_updated_date":"2013-12-11T17:45:00Z","reference_number":"EMA/448547/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patients-and-consumers-working-party-and-healthcare-professionals-working-party-joint-meeting-september-2013_en.pdf"},
    {"id":"4728","name":"Presentation - Developing a framework of collaboration between EMA and academia (Marisa Papaluca)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T02:00:00Z","last_updated_date":"2016-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-developing-framework-collaboration-between-ema-and-academia-marisa-papaluca_en.pdf"},
    {"id":"4729","name":"2017 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T16:00:00Z","last_updated_date":"2018-06-06T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/2017-annual-report-european-medicines-agency_en.pdf"},
    {"id":"4730","name":"Questions and answers on Genotropin and associated names (somatropin injection)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMEA/H/A-6(12)/001251","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_lt.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-genotropin-and-associated-names-somatropin-injection_sv.pdf"}},
    {"id":"4732","name":"Public consultation on the joint heads of medicines agencies /European medicines agency training project team ‘draft strategy for regulatory and scientific training within the European regulatory network’","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-29T02:00:00Z","last_updated_date":"2009-07-29T02:00:00Z","reference_number":"EMEA/460027/2009","document_url":"https://www.ema.europa.eu/en/documents/other/public-consultation-joint-heads-medicines-agencies-european-medicines-agency-training-project-team-draft-strategy-regulatory-and-scientific-training-within-european-regulatory-network_en.pdf"},
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    {"id":"4738","name":"Proposal for amendments of the Management Board rules on the Agency fees for various activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-10-01T02:09:21Z","last_updated_date":"2009-10-01T02:09:21Z","reference_number":"EMEA/MB/170391/2009/Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/other/proposal-amendments-management-board-rules-agency-fees-various-activities_en.pdf"},
    {"id":"4739","name":"Revised EudraVigilance access policy: impact on stakeholders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T13:18:00Z","last_updated_date":"2016-10-10T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/revised-eudravigilance-access-policy-impact-stakeholders_en.pdf"},
    {"id":"4740","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Roxadustat for treatment of anaemia due to chronic disorders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/112432/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-roxadustat-treatment-anaemia-due-chronic-disorders_en.pdf"},
    {"id":"4741","name":"Report from the CAT expert meeting - Scientific and regulatory considerations for adeno-associated viral vector (AAV)-based gene therapy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T02:00:00Z","last_updated_date":"2018-07-19T02:00:00Z","reference_number":"EMA/CAT/60852/2018","document_url":"https://www.ema.europa.eu/en/documents/report/report-cat-expert-meeting-scientific-and-regulatory-considerations-adeno-associated-viral-vector-aav-based-gene-therapy_en.pdf"},
    {"id":"4743","name":"Draft list of references supporting the assessment of Syzygium aromaticum (L.) Merill et L.M. Perry, flos and Syzygium aromaticum (L.) Merill et L.M. Perry, floris aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-03-28T02:00:00Z","last_updated_date":"2011-03-28T02:00:00Z","reference_number":"EMA/HMPC/534948/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-syzygium-aromaticum-l-merill-et-lm-perry-flos-and-syzygium-aromaticum-l-merill-et-lm-perry-floris-aetheroleum_en.pdf"},
    {"id":"4744","name":"Overview of comments received on 'Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients (formerly CPMP/EWP/6235/04 Rev.1)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T15:40:00Z","last_updated_date":"2016-11-29T15:40:00Z","reference_number":"EMA/452872/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-medicinal-products-prevention-venous-thromboembolism-vte-non-surgical-patients-formerly-cpmpewp623504-rev1_en.pdf"},
    {"id":"4746","name":"Veterinary Centralised Procedure, J Kieffer, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/veterinary-centralised-procedure-j-kieffer-ema_en.pdf"},
    {"id":"4747","name":"EU/3/18/1980: Public summary of opinion on orphan designation: Levosimendan for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/71249/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181980-public-summary-opinion-orphan-designation-levosimendan-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"4748","name":"Presentation - What endpoints should be used in clinical trials of hospital- and ventilator-acquired pneumonia?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:48Z","last_updated_date":"2011-04-26T18:05:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-endpoints-should-be-used-clinical-trials-hospital-and-ventilator-acquired-pneumonia_en.pdf"},
    {"id":"4749","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - June 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-06-30T02:00:00Z","last_updated_date":"2008-06-30T02:00:00Z","reference_number":"EMEA/346149/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-june-2008_en.pdf"},
    {"id":"4750","name":"Agenda - CAT agenda of the 13-14 February 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-02-18T11:30:00Z","last_updated_date":"2014-02-18T11:30:00Z","reference_number":"EMA/CAT/89478/2014 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-13-14-february-2014-meeting_en.pdf"},
    {"id":"4751","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 22-24 June 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-07-04T16:05:00Z","last_updated_date":"2016-07-04T16:05:00Z","reference_number":"EMA/PDCO/448103/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-22-24-june-2016_en.pdf"},
    {"id":"4753","name":"Presentation - Expectations to the European paediatric network from a research-based pharmaceutical company","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:52Z","last_updated_date":"2011-05-27T15:25:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-expectations-european-paediatric-network-research-based-pharmaceutical-company_en.pdf"},
    {"id":"4754","name":"SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T01:00:00Z","last_updated_date":"2017-02-24T01:00:00Z","reference_number":"EMA/118223/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/sglt2-inhibitors-information-potential-risk-toe-amputation-be-included-prescribing-information_en.pdf"},
    {"id":"4756","name":"Cinnamomi ceylanici aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/416/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cinnamomi-ceylanici-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4757","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Sylvant (siltuximab) for the treatment of Castleman’s disease","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-06-19T02:00:00Z","last_updated_date":"2014-06-19T02:00:00Z","reference_number":"EMA/COMP/211041/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-sylvant-siltuximab-treatment-castlemans-disease_en.pdf"},
    {"id":"4758","name":"European Review System (EURS): Open invitation to Tender No. EMEA/2006/34/PM and specifications - Version 1.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-08-29T02:00:00Z","last_updated_date":"2006-08-29T02:00:00Z","reference_number":"EMEA/337919/2006","document_url":"https://www.ema.europa.eu/en/documents/other/european-review-system-eurs-open-invitation-tender-no-emea200634pm-and-specifications-version-10_en.pdf"},
    {"id":"4759","name":"Presentation - Case study: large scale analytics for electronic health records: lessons from Observational Health Data Science and Informatics (OHDSI) (Patrick Ryan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-large-scale-analytics-electronic-health-records-lessons-observational-health-data-science-and-informatics-ohdsi-patrick-ryan_en.pdf"},
    {"id":"4760","name":"Overview of comments received on Community herbal monograph on Olea europaea L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2012-04-18T17:30:00Z","last_updated_date":"2012-04-18T17:30:00Z","reference_number":"EMA/HMPC/736741/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-olea-europaea-l-folium_en.pdf"},
    {"id":"4761","name":"Presentation - Capitalising on EU Network Training Centre for capacity and capability building in the EU network (Zaide Frias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T02:00:00Z","last_updated_date":"2016-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-capitalising-eu-network-training-centre-capacity-and-capability-building-eu-network-zaide-frias_en.pdf"},
    {"id":"4762","name":"Meeting of the EMEA working party on herbal medicinal products 13 and 14 March 2001","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-03-23T01:00:00Z","last_updated_date":"2001-03-23T01:00:00Z","reference_number":"EMEA/HMPWP/6/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-13-and-14-march-2001_en.pdf"},
    {"id":"4765","name":"Questions and answers on monoclonal antibodies for veterinary use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-12-11T15:00:00Z","last_updated_date":"2017-12-11T15:00:00Z","reference_number":"EMA/CVMP/ADVENT/307606/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-monoclonal-antibodies-veterinary-use_en.pdf"},
    {"id":"4773","name":"Superseded  list of references supporting the assessment report on: Valeriana officinalis L., radix (EMEA/HMPC/167391/2006)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-11-29T00:09:21Z","last_updated_date":"2016-04-28T01:09:21Z","reference_number":"EMEA/HMPC/167392/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-valeriana-officinalis-l-radix-emeahmpc1673912006_en.pdf"},
    {"id":"4774","name":"EU/3/15/1468: Public summary of positive opinion for orphan designation of  adeno-associated viral vector serotype 9 containing the human glucocerebrosidase gene for the treatment of Gaucher disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/COMP/125699/2015 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151468-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-containing-human-glucocerebrosidase-gene-treatment-gaucher-disease_en.pdf"},
    {"id":"4775","name":"Plendil - Article 30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"EMA/707004/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/plendil-article-30-referral-assessment-report_en.pdf"},
    {"id":"4779","name":"Assessment of the paediatric needs - Diabetes (types I and II)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-07-04T02:00:00Z","last_updated_date":"2008-07-04T02:00:00Z","reference_number":"EMEA/224688/2006/rev1","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-diabetes-types-i-and-ii_en.pdf"},
    {"id":"4780","name":"Presentation - European Patients’ Academy (EUPATI) update (Maria Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-patients-academy-eupati-update-maria-mavris_en.pdf"},
    {"id":"4781","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 22-25 June 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-07-02T12:15:00Z","last_updated_date":"2015-07-02T12:15:00Z","reference_number":"EMA/28022/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-22-25-june-2015_en.pdf"},
    {"id":"4785","name":"Agenda - 2009 EMEA MUMS Info Day: Procedural advice for classification and incentives for veterinary medicinal products indicated for Minor Use Minor Species Limited Markets","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-08-28T02:09:21Z","last_updated_date":"2009-08-28T02:09:21Z","reference_number":"EMEA/487062/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2009-emea-mums-info-day-procedural-advice-classification-and-incentives-veterinary-medicinal-products-indicated-minor-use-minor-species-limited-markets_en.pdf"},
    {"id":"4794","name":"Withdrawal assessment report for Solithromycin Triskel EU Services","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-06-02T02:00:00Z","last_updated_date":"2017-06-02T02:00:00Z","reference_number":"EMA/CHMP/226929/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-solithromycin-triskel-eu-services_en.pdf"},
    {"id":"4795","name":"Opinion following an Article 34(1) referral for Baytril 10% oral solution and associated names: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-11-20T10:15:00Z","last_updated_date":"2012-11-20T10:15:00Z","reference_number":"EMA/511421/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-341-referral-baytril-10-oral-solution-and-associated-names-background-information_sv.pdf"}},
    {"id":"4796","name":"Questions and Answers on the review of non-selective NSAIDs","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2006-09-26T02:09:21Z","last_updated_date":"2006-09-26T02:09:21Z","reference_number":"EMEA/376641/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-non-selective-nsaids_en.pdf"},
    {"id":"4798","name":"Frequently asked questions - Travel reimbursement rules for candidates","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T14:10:00Z","last_updated_date":"2018-04-09T16:22:00Z","reference_number":"EMA/407052/2013 ","document_url":"https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-travel-reimbursement-rules-candidates_en.pdf"},
    {"id":"4800","name":"Clindamycin phosphate / tretinoin: List of nationally authorised medicinal products - PSUSA/00010080/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-16T12:00:00Z","last_updated_date":"2018-04-16T12:02:18Z","reference_number":"EMA/234056/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/clindamycin-phosphate-tretinoin-list-nationally-authorised-medicinal-products-psusa00010080201707_en.pdf"},
    {"id":"4802","name":"EU/3/15/1575: Public summary of opinion on orphan designation: Humanised fusion protein consisting of extracellular domain of CD24 linked to IgG1 Fc domain for the prevention of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/COMP/697070/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151575-public-summary-opinion-orphan-designation-humanised-fusion-protein-consisting-extracellular-domain-cd24-linked-igg1-fc-domain-prevention-graft-versus-host-disease_en.pdf"},
    {"id":"4803","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revestive (teduglutide) for the treatment of short-bowel syndrome","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-09-26T02:00:00Z","last_updated_date":"2022-09-09T02:00:00Z","reference_number":"EMA/COMP/452266/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-revestive-teduglutide-treatment-short-bowel-syndrome_en.pdf"},
    {"id":"4806","name":"Presentation - Working to protect public health in the European Union (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-protect-public-health-european-union-ivana-silva_en.pdf"},
    {"id":"4809","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Adcetris (brentuximab vedotin) for the treatment of Hodgkin lymphoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-11-28T16:01:00Z","last_updated_date":"2012-11-28T16:01:00Z","reference_number":"EMA/COMP/601841/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-adcetris-brentuximab-vedotin-treatment-hodgkin-lymphoma_en.pdf"},
    {"id":"4816","name":"Presentation - Active pharmaceutical ingredients – The new approach for third countries: Perspectives from an acceding country (Anita SuÄić)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-active-pharmaceutical-ingredients-new-approach-third-countries-perspectives-acceding-country-anita-suaia_en.pdf"},
    {"id":"4817","name":"Procedural advice on the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced therapy medicinal products","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-17T02:00:00Z","last_updated_date":"2016-12-07T01:00:00Z","reference_number":"EMEA/CAT/418458/2008/corr.","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-certification-quality-and-non-clinical-data-small-and-medium-sized-enterprises-developing-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"4819","name":"Overview of comments received on 'Guideline on core SmPC for plasma-derived fibrin sealant / haemostatic products'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T12:00:00Z","last_updated_date":"2015-06-25T12:00:00Z","reference_number":"EMA/CHMP/BPWP/316655/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-core-smpc-plasma-derived-fibrin-sealant-haemostatic-products_en.pdf"},
    {"id":"4820","name":"Tiamulin (extension to rabbits): Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T00:09:21Z","last_updated_date":"2000-01-01T00:09:21Z","reference_number":"EMEA/MRL/724/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tiamulin-extension-rabbits-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"4821","name":"Presentation - Regulatory tools for managing the risk of medication errors: labelling and patient information (Jan MacDonald)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-tools-managing-risk-medication-errors-labelling-and-patient-information-jan-macdonald_en.pdf"},
    {"id":"4824","name":"EU/3/17/1835: Public summary of opinion on orphan designation: Ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the COL7A1 gene for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/68550/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171835-public-summary-opinion-orphan-designation-ex-vivo-expanded-autologous-keratinocytes-transduced-retroviral-vector-containing-col7a1-gene-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"4826","name":"Committee for Proprietary Medicinal Products (CPMP): meeting of 13 to 15 November 2001","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-11-16T00:09:21Z","last_updated_date":"2001-11-16T00:09:21Z","reference_number":"EMEA/CPMP/3658/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-meeting-13-15-november-2001_en.pdf"},
    {"id":"4830","name":"EU/3/16/1651: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase for the treatment of Angelman syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/235552/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161651-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-9-carrying-gene-human-e6-ap-ubiquitin-protein-ligase-treatment-angelman-syndrome_en.pdf"},
    {"id":"4831","name":"EudraVigilance go-live plan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-04T15:40:00Z","last_updated_date":"2017-10-16T11:30:00Z","reference_number":"EMA/399493/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-go-live-plan_en.pdf"},
    {"id":"4833","name":"Presentation - Industry proposals: How to interact with and use EnprEMA (Ali Harrison, AstraZeneca)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-proposals-how-interact-and-use-enprema-ali-harrison-astrazeneca_en.pdf"},
    {"id":"4836","name":"Presentation - Regulatory HTA parallel scientific advice throughout the life-cycle of the product (Jane Moseley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T18:21:00Z","last_updated_date":"2017-05-12T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-hta-parallel-scientific-advice-throughout-life-cycle-product-jane-moseley_en.pdf"},
    {"id":"4841","name":"Presentation - CAT’s views on classification of ATMPs: homologous use (Nicolas Ferry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-12T19:00:00Z","last_updated_date":"2015-05-12T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cats-views-classification-atmps-homologous-use-nicolas-ferry_en.pdf"},
    {"id":"4844","name":"CHMP summary of opinion for Flixabi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/793732/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-flixabi_en.pdf"},
    {"id":"4845","name":"Committee for Orphan Medicinal Products: June 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-06-20T02:00:00Z","last_updated_date":"2005-06-20T02:00:00Z","reference_number":"EMEA/COMP/203574/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-june-2005-meeting_en.pdf"},
    {"id":"4850","name":"External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.2","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-04-12T17:00:02Z","last_updated_date":"2017-04-12T17:00:02Z","reference_number":"EMA/90915/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use-version-12_en.pdf"},
    {"id":"4851","name":"EU/3/09/635: Public summary of positive opinion for orphan designation of treprostinil diethanolamine for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-09T02:00:00Z","last_updated_date":"2009-06-09T02:00:00Z","reference_number":"EMEA/COMP/228584/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309635-public-summary-positive-opinion-orphan-designation-treprostinil-diethanolamine-treatment-systemic-sclerosis_en.pdf"},
    {"id":"4855","name":"Lukasz Kniola (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/lukasz-kniola-doi_en.pdf"},
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    {"id":"4868","name":"EU/3/07/487: Public summary of positive opinion for orphan designation of 4-ethoxy-2-(piperazin-1-yl)-7-(pyridin-4-yl)-5H-pyrimido[5,4-b]indol for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/141024/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307487-public-summary-positive-opinion-orphan-designation-4-ethoxy-2-piperazin-1-yl-7-pyridin-4-yl-5h-pyrimido54-bindol-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
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    {"id":"4874","name":"EU/3/05/263: Public summary of positive opinion for orphan designation of dimethyl sulfoxide for the treatment of severe closed traumatic brain injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2005-07-01T02:00:00Z","reference_number":"EMEA/COMP/159828/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305263-public-summary-positive-opinion-orphan-designation-dimethyl-sulfoxide-treatment-severe-closed-traumatic-brain-injury_en.pdf"},
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    {"id":"4877","name":"Final list of references supporting the assessment of Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-10-06T02:00:00Z","last_updated_date":"2014-10-06T02:00:00Z","reference_number":"EMA/HMPC/680617/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
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    {"id":"4885","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the sixty-fourth meeting of the committee for veterinary medicinal products took place in London on 13-15 March 2001.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-03-15T12:29:21Z","last_updated_date":"2001-03-15T12:29:21Z","reference_number":"EMEA/CVMP/287/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-sixty-fourth-meeting-committee-veterinary-medicinal-products-took-place-london-13-15-march-2001_en.pdf"},
    {"id":"4886","name":"EU/3/16/1653: Public summary of opinion on orphan designation: Resiquimod for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-31T02:00:00Z","last_updated_date":"2016-05-31T02:00:00Z","reference_number":"EMA/COMP/240708/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161653-public-summary-opinion-orphan-designation-resiquimod-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
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    {"id":"4891","name":"EU/3/06/396: Public summary of positive opinion for orphan designation of\n\ncardiotrophin-1 for the prevention of the ischemia/reperfusion injury associated with solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/188219/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306396-public-summary-positive-opinion-orphan-designation-cardiotrophin-1-prevention-ischemiareperfusion-injury-associated-solid-organ-transplantation_en.pdf"},
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    {"id":"4893","name":"Withdrawal assessment report for Ixempra","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-06-04T02:00:00Z","last_updated_date":"2009-06-04T02:00:00Z","reference_number":"EMEA/594033/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ixempra_en.pdf"},
    {"id":"4894","name":"First monoclonal antibody in veterinary medicine recommended for marketing authorisation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-02-17T01:00:00Z","last_updated_date":"2017-02-17T01:00:00Z","reference_number":"EMA/CVMP/113787/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-monoclonal-antibody-veterinary-medicine-recommended-marketing-authorisation_en.pdf"},
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    {"id":"4914","name":"Presentation - Environmental risk assessments: EU clinical trials with GMO-based ATMPs (Ann Gorman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-environmental-risk-assessments-eu-clinical-trials-gmo-based-atmps-ann-gorman_en.pdf"},
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    {"id":"4924","name":"European Directorate for the Quality of Medicines (EDQM) - Isabelle Mercier","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-directorate-quality-medicines-edqm-isabelle-mercier_en.pdf"},
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    {"id":"4930","name":"Committee for Medicinal Products for Human Use (CHMP) - April 2006 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-05-12T02:00:00Z","last_updated_date":"2006-05-12T02:00:00Z","reference_number":"EMEA/CHMP/111495/2006, Rev 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-april-2006-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"4935","name":"Redistribution of the UK centrally authorised product portfolio - European Medicines Agency working groups on committees’ operational preparedness","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-04-11T16:00:00Z","last_updated_date":"2018-04-11T16:00:00Z","reference_number":"EMA/17176/2018","document_url":"https://www.ema.europa.eu/en/documents/other/redistribution-uk-centrally-authorised-product-portfolio-european-medicines-agency-working-groups-committees-operational-preparedness_en.pdf"},
    {"id":"4936","name":"Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/BWP/157653/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-production-characterisation-and-specifications-monoclonal-antibodies-and-related-products_en.pdf"},
    {"id":"4937","name":"CHMP summary of positive opinion for Vepacel","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-12-16T01:00:00Z","last_updated_date":"2011-12-16T01:00:00Z","reference_number":"EMA/CHMP/932537/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vepacel_en.pdf"},
    {"id":"4940","name":"Committee for Medicinal Products for Human Use (CHMP) - January 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-01-28T00:09:21Z","last_updated_date":"2010-01-28T00:09:21Z","reference_number":"EMA/CHMP/35712/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-january-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"4941","name":"Presentation - European Medicines Agency Technical Anonymisation Group (TAG) (Monica Dias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-technical-anonymisation-group-tag-monica-dias_en.pdf"},
    {"id":"4943","name":"Work plan for Good Clinical Practice Inspectors Working Group 2013","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2013-01-29T09:35:00Z","last_updated_date":"2013-01-29T09:35:00Z","reference_number":"EMA/569405/2012","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-good-clinical-practice-inspectors-working-group-2013_en.pdf"},
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    {"id":"4946","name":"Draft assessment report on Malva sylvestris L. and/or Malva neglecta Wallr., folium and Malva sylvestris L., flos - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"EMA/HMPC/749518","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-malva-sylvestris-l-andor-malva-neglecta-wallr-folium-and-malva-sylvestris-l-flos-first-version_en.pdf"},
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    {"id":"5124","name":"Appendix 1 - Draft guideline on the requirements for clinical documentation for Orally Inhaled Products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatme...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/CHMP/EWP/48501/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/appendix-1-draft-guideline-requirements-clinical-documentation-orally-inhaled-products-oip-including-requirements-demonstration-therapeutic-equivalence-between-two-inhaled-products-use-treatme_en.pdf"},
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    {"id":"5134","name":"Scientific recommendation on classification of advanced therapy medicinal products: Bone marrow derived lineage negative heterogenic stem and progenitor cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T16:30:00Z","last_updated_date":"2017-02-02T16:30:00Z","reference_number":"EMA/54559/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-bone-marrow-derived-lineage-negative-heterogenic-stem-and-progenitor-cells_en.pdf"},
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    {"id":"5175","name":"Ensuring safe and effective medicines for an ageing population: Workshop proceedings","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-08-17T02:00:00Z","last_updated_date":"2012-08-17T02:00:00Z","reference_number":"EMA/425943/2012","document_url":"https://www.ema.europa.eu/en/documents/report/ensuring-safe-and-effective-medicines-ageing-population-workshop-proceedings_en.pdf"},
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    {"id":"5190","name":"EU/3/18/1983: Public summary of opinion on orphan designation: Pyridoxal 5'-phosphate for the treatment of pyridoxamine 5'-phosphate oxidase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/67937/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181983-public-summary-opinion-orphan-designation-pyridoxal-5-phosphate-treatment-pyridoxamine-5-phosphate-oxidase-deficiency_en.pdf"},
    {"id":"5192","name":"Zydelig Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-notification_en.pdf"},
    {"id":"5198","name":"EU/3/11/886: Public summary of opinion on orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the treatment of post-polycythaemia vera myelofibrosi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2013-06-20T13:00:00Z","reference_number":"EMA/COMP/407857/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311886-public-summary-opinion-orphan-designation-n-cyanomethyl-4-2-4-morpholin-4-ylphenylaminopyrimidin-4-ylbenzamide-dihydrochloride-salt-treatment-post-polycythaemia-vera-myelofibrosi_en.pdf"},
    {"id":"5199","name":"Opinion following an Article 34 referral for Methoxasol-t: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-08-02T01:59:00Z","last_updated_date":"2008-08-02T01:59:00Z","reference_number":"EMEA/458933/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-34-referral-methoxasol-t-background-information_sv.pdf"}},
    {"id":"5201","name":"GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T13:00:00Z","last_updated_date":"2015-01-23T13:00:00Z","reference_number":"EMA/37763/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/gvk-biosciences-european-medicines-agency-recommends-suspending-medicines-over-flawed-studies_en.pdf"},
    {"id":"5202","name":"Presentation - Working group on antibiotics","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-06T01:00:00Z","last_updated_date":"2017-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-antibiotics_en.pdf"},
    {"id":"5204","name":"Testosterone (all formulations apart from topical use and testosterone undecanoate injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the 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    {"id":"5212","name":"EU/3/04/213: Public summary of positive opinion for orphan designation of mepolizumab for the treatment of hypereosinophilic syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2020-10-23T02:00:00Z","reference_number":"EMEA/COMP/292/04 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304213-public-summary-positive-opinion-orphan-designation-mepolizumab-treatment-hypereosinophilic-syndrome_en.pdf"},
    {"id":"5214","name":"PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-06-09T16:00:00Z","last_updated_date":"2017-06-09T16:00:00Z","reference_number":"EMA/365357/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-concludes-there-no-evidence-change-known-risk-neutropenic-enterocolitis-docetaxel_en.pdf"},
    {"id":"5218","name":"Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Lumiracoxib, Parecoxib, and Valdecoxib International Non-Proprietary Name (INN): Lumiracoxib: Background 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    {"id":"5219","name":"Presentation - Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (Andrzej Rys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-best-use-medicines-legislation-bring-new-antibiotics-patients-and-combat-resistance-problem-andrzej-rys_en.pdf"},
    {"id":"5220","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human foetal neural stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-07-13T15:40:00Z","last_updated_date":"2018-07-13T15:40:00Z","reference_number":"EMA/381068/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-foetal-neural-stem-cells_en.pdf"},
    {"id":"5221","name":"Overview of comments on 'qualification opinion of low hippocampal volume (atrophy) by magnetic-resonance imaging for use in clinical trials for regulatory purpose in predementia stage of Alzheimer’s disease'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-09T11:43:00Z","last_updated_date":"2011-12-09T11:43:00Z","reference_number":"EMA/879297/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-qualification-opinion-low-hippocampal-volume-atrophy-magnetic-resonance-imaging-use-clinical-trials-regulatory-purpose-predementia-stage-alzheimers-disease_en.pdf"},
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    {"id":"5224","name":"Opinion following an Article 31 referral for Loratadine International Non-Proprietary Name (INN): loratadine: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-04-28T02:08:21Z","last_updated_date":"2004-04-28T02:08:21Z","reference_number":"CPMP/1333/03","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-31-referral-loratadine-international-non-proprietary-name-inn-loratadine-background-information_sv.pdf"}},
    {"id":"5230","name":"Presentation - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agencyeuropean-federation-pharmaceutical-industries-and-associations-workshop-integrating-pharmacogenomics-early-drug-development-pharmacokinetics-working-example_en.pdf"},
    {"id":"5231","name":"Draft assessment report on Crataegus spp., folium cum flore","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-10-14T02:00:00Z","last_updated_date":"2014-10-14T02:00:00Z","reference_number":"EMA/HMPC/159076/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"5233","name":"Presentation - Subgroup analysis: A view from an industry statistician (Keene)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subgroup-analysis-view-industry-statistician-keene_en.pdf"},
    {"id":"5234","name":"Final public statement on Euphrasia officinalis L. and Euphrasia rostkoviana Hayne), herba","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/727465/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-euphrasia-officinalis-l-and-euphrasia-rostkoviana-hayne-herba_en.pdf"},
    {"id":"5235","name":"Draft guideline on Core SmPC for human normal immunoglobulin for intravenous administration (IVIg) (CPMP/BPWG/859/95 rev. 3)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-02-06T01:00:00Z","last_updated_date":"2009-02-06T01:00:00Z","reference_number":"CPMP/BPWG/859/95 Rev. 3 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-normal-immunoglobulin-intravenous-administration-ivig-cpmpbpwg85995-rev-3_en.pdf"},
    {"id":"5236","name":"Common position between patients’, consumers, and healthcare professionals’ organisations involved in the activities of the European Medicines Agency on:\n\nSupply shortages of medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-10T16:25:00Z","last_updated_date":"2014-02-10T16:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/common-position-between-patients-consumers-and-healthcare-professionals-organisations-involved-activities-european-medicines-agency-supply-shortages-medicines_en.pdf"},
    {"id":"5237","name":"Presentation - Patient and Healthcare Professional Involvement in EUnetHTA Activities (Michelle Mujoomdar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-and-healthcare-professional-involvement-eunethta-activities-michelle-mujoomdar_en.pdf"},
    {"id":"5238","name":"CHMP summary of positive opinion for Nuedexta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/CHMP/132029/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nuedexta_en.pdf"},
    {"id":"5239","name":"Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-10-18T16:32:00Z","reference_number":"EMA/50389/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/flunarizine-list-nationally-authorised-medicinal-products-psusa00001416201505_en.pdf"},
    {"id":"5240","name":"Questions and answers on the withdrawal of the marketing authorisation application for Ozespa","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-01-31T01:00:00Z","reference_number":"EMA/40202/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ozespa_sv.pdf"}},
    {"id":"5241","name":"Final public statement on Viscum album L., herba","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T17:05:00Z","last_updated_date":"2013-08-01T17:05:00Z","reference_number":"EMA/HMPC/57109/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-viscum-album-l-herba_en.pdf"},
    {"id":"5242","name":"EU/3/08/591: Public summary of positive opinion for orphan designation of 5-(ethylsulfonyl)-2-(naphthalen-2-yl)benzo[d]oxazole for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"EMEA/COMP/556772/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308591-public-summary-positive-opinion-orphan-designation-5-ethylsulfonyl-2-naphthalen-2-ylbenzodoxazole-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"5244","name":"Presentation - Commission call for expression of interest for the position of member of the Pharmacovigilance Risk Assessment Committee","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-commission-call-expression-interest-position-member-pharmacovigilance-risk-assessment-committee_en.pdf"},
    {"id":"5247","name":"News bulletin for small and medium-sized enterprises - Issue 27","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-03-31T13:10:00Z","last_updated_date":"2014-03-31T13:10:00Z","reference_number":"Issue 27","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-27_en.pdf"},
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    {"id":"5251","name":"Agenda for the 69th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/MB/660138/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-69th-meeting-management-board_en.pdf"},
    {"id":"5252","name":"Final VICH GL53: Electronic exchange of documents: electronic file format","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-03-20T16:00:00Z","last_updated_date":"2015-10-01T11:00:00Z","reference_number":"EMA/CVMP/VICH/758781/2013 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/final-vich-gl53-electronic-exchange-documents-electronic-file-format_en.pdf"},
    {"id":"5253","name":"EU/3/06/409: Public summary of  positive opinion for orphan designation of  l-asparaginase encapsulated in erythrocytes  for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/359204/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306409-public-summary-positive-opinion-orphan-designation-l-asparaginase-encapsulated-erythrocytes-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
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    {"id":"5257","name":"Group working procedures – Dr Isabelle Moulon","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-08T02:00:00Z","last_updated_date":"2003-05-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/group-working-procedures-dr-isabelle-moulon_en.pdf"},
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    {"id":"5263","name":"Practical considerations on the impact of the new pharmaceutical legislation on marketing-authorisation applications via the centralised procedure and centrally authorised medicinal products for veterinary use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-10-17T02:00:00Z","last_updated_date":"2005-10-17T02:00:00Z","reference_number":"EMEA/316976/2005","document_url":"https://www.ema.europa.eu/en/documents/other/practical-considerations-impact-new-pharmaceutical-legislation-marketing-authorisation-applications-centralised-procedure-and-centrally-authorised-medicinal-products-veterinary-use_en.pdf"},
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    {"id":"5272","name":"Overview of comments received on 'Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T12:40:00Z","last_updated_date":"2016-01-19T12:40:00Z","reference_number":"EMA/839636/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-chemical-structure-and-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances_en.pdf"},
    {"id":"5273","name":"Retinoid Article-31 referral - Divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-divergent-position_en.pdf"},
    {"id":"5275","name":"Draft community herbal monograph on Gentiana lutea L., radix - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-03-12T00:09:21Z","last_updated_date":"2009-03-12T00:09:21Z","reference_number":"EMEA/HMPC/578324/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-gentiana-lutea-l-radix-first-version_en.pdf"},
    {"id":"5277","name":"European Union Telematics strategy 2014-2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-30T16:00:00Z","last_updated_date":"2014-09-30T16:00:00Z","reference_number":"EMA/289808/2014","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-telematics-strategy-2014-2016_en.pdf"},
    {"id":"5278","name":"Ethinylestradiol  / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-17T13:10:00Z","last_updated_date":"2017-11-17T13:10:00Z","reference_number":"EMA/757865/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethinylestradiol-gestodene-transdermal-application-list-nationally-authorised-medicinal-products-psusa00010145201702_en.pdf"},
    {"id":"5281","name":"Guideline on control of impurities of pharmacopoeial substances:\n\ncompliance with the european pharmacopoeia general\n\nmonograph \"substances for pharmaceutical use\" and\n\ngeneral chapter \"control of impurities in substance...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-04-22T02:00:00Z","last_updated_date":"2004-04-22T02:00:00Z","reference_number":"CPMP/QWP/1529/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-control-impurities-pharmacopoeial-substances-compliance-european-pharmacopoeia-general-monograph-substances-pharmaceutical-use-and-general-chapter-control-impurities-substance_en.pdf"},
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    {"id":"5287","name":"Ten years of orphan medicines legislation in Europe – European Medicines Agency reviews success and looks ahead","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"EMA/291560/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/ten-years-orphan-medicines-legislation-europe-european-medicines-agency-reviews-success-and-looks-ahead_en.pdf"},
    {"id":"5288","name":"Third Meeting of the Management Board of the European Agency for the Evaluation of Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1994-06-23T02:00:00Z","last_updated_date":"1994-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/third-meeting-management-board-european-agency-evaluation-medicinal-products_en.pdf"},
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    {"id":"5292","name":"Presentation - Guidance on the anonymisation of clinical reports for the purpose of publication - Meeting on redacting commercially confidential information (CCI) in clinical reports and anonymising clinical reports for ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T02:00:00Z","last_updated_date":"2015-09-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-anonymisation-clinical-reports-purpose-publication-meeting-redacting-commercially-confidential-information-cci-clinical-reports-and-anonymising-clinical-reports_en.pdf"},
    {"id":"5296","name":"Presentation - Kite Pharma: Industry perspective - PRIME medicines (Rizwana Sproule)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-07T02:00:00Z","last_updated_date":"2017-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-kite-pharma-industry-perspective-prime-medicines-rizwana-sproule_en.pdf"},
    {"id":"5298","name":"Presentation - Architecture of the European medicines agency: How to improve the architecture of the EMA to make it better equipped for the future","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-architecture-european-medicines-agency-how-improve-architecture-ema-make-it-better-equipped-future_en.pdf"},
    {"id":"5300","name":"European Paediatric Network at the EMEA - Objectives of the European network - Dr Irmgard Eichler","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-paediatric-network-emea-objectives-european-network-dr-irmgard-eichler_en.pdf"},
    {"id":"5305","name":"Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Aluminium salicylate, basic","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-12-12T15:16:00Z","last_updated_date":"2016-12-12T15:16:00Z","reference_number":"EMA/CVMP/453264/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits-aluminium-salicylate-basic_en.pdf"},
    {"id":"5307","name":"Agenda - Sixth annual face to face meeting of European network of paediatric research at the European Medicines Agency Coordinating Group members - 27 June 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-06-18T19:00:00Z","last_updated_date":"2014-06-18T19:00:00Z","reference_number":"EMA/245783/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sixth-annual-face-face-meeting-european-network-paediatric-research-european-medicines-agency-coordinating-group-members-27-june-2014_en.pdf"},
    {"id":"5309","name":"Human medicines highlights - May 2012","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2012-06-01T17:10:00Z","last_updated_date":"2012-06-01T17:10:00Z","reference_number":"Issue 40","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-may-2012_en.pdf"},
    {"id":"5311","name":"EU/3/16/1627: Public summary of opinion on orphan designation: Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes for the treatment of post-transplant lymphoproliferative disorder","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-03T18:30:00Z","last_updated_date":"2016-05-03T18:30:00Z","reference_number":"EMA/COMP/151270/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161627-public-summary-opinion-orphan-designation-allogeneic-epstein-barr-virus-specific-cytotoxic-t-lymphocytes-treatment-post-transplant-lymphoproliferative-disorder_en.pdf"},
    {"id":"5312","name":"Twelfth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-12-05T01:00:00Z","last_updated_date":"1996-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/twelfth-meeting-management-board_en.pdf"},
    {"id":"5314","name":"Report on annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), 22-23 March 2012","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-04-11T13:40:00Z","last_updated_date":"2013-04-11T13:40:00Z","reference_number":"EMA/218181/2013","document_url":"https://www.ema.europa.eu/en/documents/report/report-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema-22-23-march-2012_en.pdf"},
    {"id":"5315","name":"CHMP summary of positive opinion for Verzenios","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/420258/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-verzenios_en.pdf"},
    {"id":"5320","name":"News bulletin for small and medium-sized enterprises - Issue 2","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2007-09-01T02:00:00Z","last_updated_date":"2007-09-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-2_en.pdf"},
    {"id":"5323","name":"Note for guidance on the establishment of maximum residue limits for minor animal species","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T01:00:00Z","last_updated_date":"1997-11-01T01:00:00Z","reference_number":"EMEA/CVMP/153a/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-establishment-maximum-residue-limits-minor-animal-species_en.pdf"},
    {"id":"5324","name":"Questions and answers on the Withdrawal of the application for a change to the marketing authorisation for Firazyr (icatibant)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/95900/2014 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-firazyr-icatibant_en.pdf"},
    {"id":"5325","name":"European Medicines Agency recommends first medical treatment for patients with short bowel syndrome","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/409283/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-first-medical-treatment-patients-short-bowel-syndrome_en.pdf"},
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    {"id":"5345","name":"Report on annual workshop of the European Network of Paediatric Research at the European Medicines Agency, 27-28 June 2013","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-08-22T13:42:00Z","last_updated_date":"2013-08-22T13:42:00Z","reference_number":"EMA/401244/2013","document_url":"https://www.ema.europa.eu/en/documents/report/report-annual-workshop-european-network-paediatric-research-european-medicines-agency-27-28-june-2013_en.pdf"},
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    {"id":"5354","name":"EU/3/07/467: Public summary of positive opinion for orphan designation of eltrombopag olamine for the treatment of idiopathic thrombocytopenic purpura","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2012-01-12T01:00:00Z","reference_number":"EMEA/COMP/287945/2007 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307467-public-summary-positive-opinion-orphan-designation-eltrombopag-olamine-treatment-idiopathic-thrombocytopenic-purpura_en.pdf"},
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    {"id":"5357","name":"EU/3/17/1960: Public summary of opinion on orphan designation: Ciclopirox for the treatment of congenital erythropoietic porphyria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-14T01:00:00Z","last_updated_date":"2018-03-14T01:00:00Z","reference_number":"EMA/844079/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171960-public-summary-opinion-orphan-designation-ciclopirox-treatment-congenital-erythropoietic-porphyria_en.pdf"},
    {"id":"5359","name":"Agenda - PRAC draft agenda of meeting 11-14 January 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-01-11T17:30:00Z","last_updated_date":"2016-01-11T17:30:00Z","reference_number":"EMA/PRAC/22240/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-11-14-january-2016_en.pdf"},
    {"id":"5360","name":"Agenda - First EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs) 'Navigating the Regulatory Maze'","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"EMEA/273211/2006","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-emea-workshop-micro-small-and-medium-sized-enterprises-smes-navigating-regulatory-maze_en.pdf"},
    {"id":"5363","name":"Outcome of the European Medicines Agency (EMA) survey on centralised initial marketing authorisation procedure 2016/2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-03-01T18:30:00Z","last_updated_date":"2018-03-01T18:30:00Z","reference_number":"EMA/338870/2017","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-european-medicines-agency-ema-survey-centralised-initial-marketing-authorisation-procedure-20162017_en.pdf"},
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    {"id":"5370","name":"Meeting report of the Seventh EMEA/FEDESA joint infoday at the European Agency in London","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-05-22T02:00:00Z","last_updated_date":"2000-05-22T02:00:00Z","reference_number":"EMEA/V/15080/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-report-seventh-emeafedesa-joint-infoday-european-agency-london_en.pdf"},
    {"id":"5372","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T17:20:00Z","last_updated_date":"2017-05-18T17:20:00Z","reference_number":"EMA/251577/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-april-2017_en.pdf"},
    {"id":"5374","name":"Pandemrix: Labelling","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-15T01:00:00Z","last_updated_date":"2010-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pandemrix-labelling_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/pandemrix-labelling_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/pandemrix-labelling_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/pandemrix-labelling_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/pandemrix-labelling_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/pandemrix-labelling_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/pandemrix-labelling_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/pandemrix-labelling_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/pandemrix-labelling_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/pandemrix-labelling_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/pandemrix-labelling_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/pandemrix-labelling_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/pandemrix-labelling_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/pandemrix-labelling_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/pandemrix-labelling_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/pandemrix-labelling_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/pandemrix-labelling_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/pandemrix-labelling_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/pandemrix-labelling_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/pandemrix-labelling_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/pandemrix-labelling_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/pandemrix-labelling_sv.pdf"}},
    {"id":"5375","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 21 to 23 January 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-01-23T01:00:00Z","last_updated_date":"2003-01-23T01:00:00Z","reference_number":"EMEA/CPMP/294/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-21-23-january-2003_en.pdf"},
    {"id":"5378","name":"Veterinary information-technology and data strategy, roadmap and management overview endorsed by European Union Telematics Management Board on 28 May 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T19:30:00Z","last_updated_date":"2014-09-26T19:30:00Z","reference_number":"EMA/717773/2013","document_url":"https://www.ema.europa.eu/en/documents/other/veterinary-information-technology-and-data-strategy-roadmap-and-management-overview-endorsed-european-union-telematics-management-board-28-may-2014_en.pdf"},
    {"id":"5379","name":"Standard operating procedure for type IB variations to centralised marketing authorisations (medicines for veterinary use)","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-05-16T02:00:00Z","last_updated_date":"2016-05-13T17:00:00Z","reference_number":"SOP/V/4011","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-type-ib-variations-centralised-marketing-authorisations-medicines-veterinary-use_en.pdf"},
    {"id":"5382","name":"Phenoxymethylpenicillin (eggs): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T15:00:00Z","last_updated_date":"2012-02-20T15:00:00Z","reference_number":"EMA/CVMP/796083/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phenoxymethylpenicillin-eggs-european-public-mrl-assessment-report-epmar-committee-medicinal-products-veterinary-use_en.pdf"},
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    {"id":"5438","name":"Meeting highlights from the Paediatric Committee: 21 -  23 November 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-27T01:00:00Z","last_updated_date":"2007-11-27T01:00:00Z","reference_number":"EMEA/553291/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-21-23-november-2007_en.pdf"},
    {"id":"5440","name":"Draft list of references for assessment of Menthae piperitae folium and Mentha x piperita L. (peppermint leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2007-07-05T02:00:00Z","reference_number":"EMEA/HMPC/262645/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-menthae-piperitae-folium-and-mentha-x-piperita-l-peppermint-leaf_en.pdf"},
    {"id":"5442","name":"EU/3/13/1139: Public summary of opinion on orphan designation: Sodium chlorite for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T14:00:00Z","last_updated_date":"2013-09-09T14:00:00Z","reference_number":"EMA/COMP/317798/2013 Corr.","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131139-public-summary-opinion-orphan-designation-sodium-chlorite-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"5444","name":"VICH GL23: Safety studies for veterinary drug residues in human food: Genotoxicity studies - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-16T02:00:00Z","last_updated_date":"2004-06-16T02:00:00Z","reference_number":"CVMP/VICH/526/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl23-safety-studies-veterinary-drug-residues-human-food-genotoxicity-studies-step-7_en.pdf"},
    {"id":"5446","name":"Presentation - NORDIC investigators network for PEDiatric MEDicines (NordicPEDMED) - Nordic Network (Kalle Hoppu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nordic-investigators-network-pediatric-medicines-nordicpedmed-nordic-network-kalle-hoppu_en.pdf"},
    {"id":"5451","name":"Dihydrostreptomycin (Extrapolation to all ruminants): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2005-07-01T02:00:00Z","reference_number":"EMEA/CVMP/211249/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dihydrostreptomycin-extrapolation-all-ruminants-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"5452","name":"Presentation - Patient reported outcomes in an era of immunotherapy drug development (David Cella) - S6.4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-reported-outcomes-era-immunotherapy-drug-development-david-cella-s64_en.pdf"},
    {"id":"5453","name":"Superseded opinion of the HMPC on a Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T11:26:00Z","last_updated_date":"2018-10-10T11:26:00Z","reference_number":"EMA/HMPC/888907/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-first-version_en.pdf"},
    {"id":"5454","name":"Final list of references supporting the assessment of Arnica montana L., flos","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/HMPC/198792/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-arnica-montana-l-flos_en.pdf"},
    {"id":"5460","name":"CHMP summary of positive opinion for Brintellix","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-10-25T15:00:00Z","last_updated_date":"2013-10-25T15:00:00Z","reference_number":"EMA/CHMP/630715/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-brintellix_en.pdf"},
    {"id":"5462","name":"Draft list of references supporting the assessment of Helichrysum arenarium (L.) Moench, flos","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-10-14T12:35:00Z","last_updated_date":"2015-10-14T12:35:00Z","reference_number":"EMA/HMPC/144093/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-helichrysum-arenarium-l-moench-flos_en.pdf"},
    {"id":"5463","name":"Superseded community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-09-02T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/HMPC/585558/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos_en.pdf"},
    {"id":"5464","name":"Overview of comments received on draft guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-12-01T01:00:00Z","last_updated_date":"2006-12-01T01:00:00Z","reference_number":"EMEA/CHMP/BWP/480303/2006 - Corr","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-environmental-risk-assessments-medicinal-products-consisting-or-containing-genetically-modified-organisms-gmos_en.pdf"},
    {"id":"5465","name":"VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-03-13T16:30:00Z","last_updated_date":"2013-03-13T16:30:00Z","reference_number":"EMA/CVMP/VICH/582610/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl50-harmonisation-criteria-waive-target-animal-batch-safety-testing-inactivated-vaccines-veterinary-use-first-version_en.pdf"},
    {"id":"5466","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 July 2013","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/CHMP/SAWP/445836/2013 ","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-22-25-july-2013_en.pdf"},
    {"id":"5467","name":"EU/3/16/1821: Public summary of opinion on orphan designation:\n\nLeuprorelin acetate for the treatment of congenital hypogonadotropic hypogonadism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/5459/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161821-public-summary-opinion-orphan-designation-leuprorelin-acetate-treatment-congenital-hypogonadotropic-hypogonadism_en.pdf"},
    {"id":"5468","name":"Agenda - PRAC draft agenda of meeting 11-14 April 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-04-11T19:30:00Z","last_updated_date":"2016-04-11T19:30:00Z","reference_number":"EMA/PRAC/262317/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-11-14-april-2016_en.pdf"},
    {"id":"5470","name":"Meronem - Article 30 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2009-12-12T00:59:00Z","last_updated_date":"2009-12-12T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/meronem-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/meronem-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/meronem-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/meronem-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/meronem-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/meronem-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/meronem-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/meronem-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/meronem-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/meronem-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/meronem-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/meronem-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/meronem-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/meronem-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/meronem-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/meronem-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/meronem-article-30-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/meronem-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/meronem-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/meronem-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/meronem-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"5471","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Zavesca","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/121008/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-zavesca_sv.pdf"}},
    {"id":"5472","name":"Minutes of the 79th meeting of the Management Board: 21-22 March 2013","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-06-18T19:00:00Z","last_updated_date":"2013-06-18T19:00:00Z","reference_number":"EMA/MB/195991/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-79th-meeting-management-board-21-22-march-2013_en.pdf"},
    {"id":"5474","name":"Presentation - Joint industry presentation: One-year industry experience – Eligibility to PRIME (Aimad Torqui)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-07T02:00:00Z","last_updated_date":"2017-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-industry-presentation-one-year-industry-experience-eligibility-prime-aimad-torqui_en.pdf"},
    {"id":"5475","name":"Reduction and prevention of antimicrobial Resistance in the veterinary sector: From a global perspective to the field level usage - How may HMA contribute - Patrick Dehaumont","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:09:21Z","last_updated_date":"2009-05-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/reduction-and-prevention-antimicrobial-resistance-veterinary-sector-global-perspective-field-level-usage-how-may-hma-contribute-patrick-dehaumont_en.pdf"},
    {"id":"5476","name":"Opinions on annual re-assessments, 5-year renewals - Adopted at the CHMP meeting of 13-16 February 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-02-21T15:12:00Z","last_updated_date":"2012-02-21T15:12:00Z","reference_number":"EMA/CHMP/86232/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-5-year-renewals-adopted-chmp-meeting-13-16-february-2012_en.pdf"},
    {"id":"5477","name":"Questions and answers on the recommendation for the refusal of the marketing authorisation for Rhucin","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2007-12-13T01:00:00Z","last_updated_date":"2007-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-rhucin_en.pdf"},
    {"id":"5478","name":"European Medicines Agency recommends restricting Trobalt to last-line therapy in partial epilepsy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T12:00:00Z","last_updated_date":"2013-05-31T12:00:00Z","reference_number":"EMA/321395/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-trobalt-last-line-therapy-partial-epilepsy_en.pdf"},
    {"id":"5479","name":"Invitation for expressions of interest - European Medicines Agency workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/292143/2015","document_url":"https://www.ema.europa.eu/en/documents/other/invitation-expressions-interest-european-medicines-agency-workshop-development-new-medicinal-products-treatment-ulcerative-colitis-and-crohns-disease_en.pdf"},
    {"id":"5481","name":"How to register with EudraVigilance and EVDAS - Training module EV-M1","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2018-07-26T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/how-register-eudravigilance-and-evdas-training-module-ev-m1_en.pdf"},
    {"id":"5482","name":"CHMP Workplan 2008-2010 “Specialised Experts and SAGs: Optimisation of Consultation process from CHMP”","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2010-04-09T02:00:00Z","last_updated_date":"2010-04-09T02:00:00Z","reference_number":"Ref. EMA/312354/2009","document_url":"https://www.ema.europa.eu/en/documents/work-programme/chmp-workplan-2008-2010-specialised-experts-and-sags-optimisation-consultation-process-chmp_en.pdf"},
    {"id":"5484","name":"Restrictions in the use of flupirtine-containing medicines - CMDh endorses PRAC recommendation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/384191/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/restrictions-use-flupirtine-containing-medicines-cmdh-endorses-prac-recommendation_en.pdf"},
    {"id":"5485","name":"EU/3/15/1513: Public summary of opinion on orphan designation: Doxorubicin for the treatment of hepatoblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/433087/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151513-public-summary-opinion-orphan-designation-doxorubicin-treatment-hepatoblastoma_en.pdf"},
    {"id":"5486","name":"Committee for medicinal products for veterinary use: Meeting of 14-16 October 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-17T02:09:21Z","last_updated_date":"2008-10-17T02:09:21Z","reference_number":"EMEA/CVMP/523644/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-14-16-october-2008_en.pdf"},
    {"id":"5487","name":"EU/3/17/1866: Public summary of opinion on orphan designation: Human normal immunoglobulin for treatment in organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/203453/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171866-public-summary-opinion-orphan-designation-human-normal-immunoglobulin-treatment-organ-transplantation_en.pdf"},
    {"id":"5488","name":"Committee for Medicinal Products for Veterinary Use: Meeting of 9-11 March 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-12T01:00:00Z","last_updated_date":"2010-03-12T01:00:00Z","reference_number":"EMA/CVMP/122502/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-9-11-march-2010_en.pdf"},
    {"id":"5489","name":"Marvel LifeSciences Ltd withdraws its marketing-authorisation applications for Solumarv, Isomarv medium and Combimarv (human insulin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/747975/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/marvel-lifesciences-ltd-withdraws-its-marketing-authorisation-applications-solumarv-isomarv-medium-and-combimarv-human-insulin_en.pdf"},
    {"id":"5493","name":"Questions and answers on Ethinylestradiol-Drospirenone 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T02:00:00Z","last_updated_date":"2013-01-11T11:57:00Z","reference_number":"EMA/257547/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-ethinylestradiol-drospirenone-244-ethinylestradiol-drospirenone-002-mg3-mg-tablets_sv.pdf"}},
    {"id":"5496","name":"Emergency contraceptives Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/emergency-contraceptives-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"5497","name":"Public statement on ChondroCelect: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-08-04T19:23:00Z","last_updated_date":"2017-01-12T18:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-chondrocelect-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"5502","name":"Presentation - Interaction with patients and consumers (2013): Review of package leaflets (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-patients-and-consumers-2013-review-package-leaflets-nathalie-bere_en.pdf"},
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    {"id":"5507","name":"VICH GL21: Efficacy of anthelmintics - Specific recommendations for poultry - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-07-30T02:00:00Z","last_updated_date":"2001-07-30T02:00:00Z","reference_number":"CVMP/VICH/546/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl21-efficacy-anthelmintics-specific-recommendations-poultry-step-7_en.pdf"},
    {"id":"5508","name":"Baxter dialysis solutions Article-31 referral - Annex I (US site)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-us-site_sv.pdf"}},
    {"id":"5509","name":"Presentation - Cystic fibrosis endpoints: difficulties encountered in the orphan procedures (Laura Fregonese)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cystic-fibrosis-endpoints-difficulties-encountered-orphan-procedures-laura-fregonese_en.pdf"},
    {"id":"5510","name":"Situation in the UK – Bee treatments, Martha Spagnuolo-Weaver, Veterinary Medicines Directorate (UK)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/situation-uk-bee-treatments-martha-spagnuolo-weaver-veterinary-medicines-directorate-uk_en.pdf"},
    {"id":"5511","name":"Thyme and primula root: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"EMA/262389/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/thyme-and-primula-root-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/thyme-and-primula-root-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/thyme-and-primula-root-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/thyme-and-primula-root-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/thyme-and-primula-root-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/thyme-and-primula-root-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/thyme-and-primula-root-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/thyme-and-primula-root-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/thyme-and-primula-root-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/thyme-and-primula-root-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/thyme-and-primula-root-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/thyme-and-primula-root-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/thyme-and-primula-root-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/thyme-and-primula-root-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/thyme-and-primula-root-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/thyme-and-primula-root-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/thyme-and-primula-root-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/thyme-and-primula-root-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/thyme-and-primula-root-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/thyme-and-primula-root-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/thyme-and-primula-root-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/thyme-and-primula-root-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/thyme-and-primula-root-summary-public_sv.pdf"}},
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    {"id":"5522","name":"European Medicines Agency is consulting on the reflection paper on the use of\n\nfluoroquinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-02-08T01:00:00Z","last_updated_date":"2006-02-08T01:00:00Z","reference_number":"EMEA/42529/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-consulting-reflection-paper-use-fluoroquinolones-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"5526","name":"Benefits of Diane 35 and generics outweigh risks in specific patient group","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T02:00:00Z","last_updated_date":"2013-05-17T02:00:00Z","reference_number":"EMA/PRAC/284754/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/benefits-diane-35-and-generics-outweigh-risks-specific-patient-group_en.pdf"},
    {"id":"5527","name":"Presentation - Increasing enrolment in clinical trials and the Increasing the Participation of the Elderly In Clinical Trials (PREDICT) study","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-increasing-enrolment-clinical-trials-and-increasing-participation-elderly-clinical-trials-predict-study_en.pdf"},
    {"id":"5531","name":"Lovastatin: List of nationally authorised medicinal products - PSUSA/00010051/201607","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T12:54:00Z","last_updated_date":"2017-03-10T12:57:29Z","reference_number":"EMA/169827/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/lovastatin-list-nationally-authorised-medicinal-products-psusa00010051201607_en.pdf"},
    {"id":"5532","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T15:00:00Z","last_updated_date":"2013-06-10T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iv_sv.pdf"}},
    {"id":"5534","name":"Annex to guideline on similar biological medicinal products containing Biotechnology-derived proteins as active substance: Non-clinical and clinical issues \n\nGuidance on similar medicinal products containing recombinant ...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-02-22T01:00:00Z","last_updated_date":"2006-02-22T01:00:00Z","reference_number":"EMEA/CHMP/BMWP/32775/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/annex-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-guidance-similar-medicinal-products-containing_en.pdf-0"},
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    {"id":"5536","name":"Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-03-10T16:00:00Z","last_updated_date":"2015-03-10T16:00:00Z","reference_number":"EMA/CVMP/303753/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-tulathromycin_en.pdf"},
    {"id":"5537","name":"Tysabri Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-05-08T14:00:00Z","last_updated_date":"2015-05-08T14:00:00Z","reference_number":"EMA/286215/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/tysabri-article-20-procedure-review-started_en.pdf"},
    {"id":"5538","name":"Overview of comments received on draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ (EMEA/HMPC/CHMP/CVMP/287539/2005 Rev.1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-28T02:00:00Z","last_updated_date":"2010-04-28T02:00:00Z","reference_number":"EMA/HMPC/710724/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-declaration-herbal-substances-and-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-emeahmpcchmpcvmp2875392005-rev1_en.pdf"},
    {"id":"5539","name":"Agenda - CAT agenda of the 18-20 July 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-07-20T15:45:00Z","last_updated_date":"2018-07-20T15:45:00Z","reference_number":"EMA/CAT/501027/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-18-20-july-2018-meeting_en.pdf"},
    {"id":"5540","name":"EU/3/07/479: Public summary of positive opinion for orphan designation of N-adamantanyl-N'-Geranyl-ethylenediamine for the treatment of tuberculosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/144397/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307479-public-summary-positive-opinion-orphan-designation-n-adamantanyl-n-geranyl-ethylenediamine-treatment-tuberculosis_en.pdf"},
    {"id":"5541","name":"European Medicines Agency and European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) launch electronic Register of Studies (E-Register)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/759118/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-european-network-centres-pharmacoepidemiology-and-pharmacovigilance-encepp-launch-electronic-register-studies-e-register_en.pdf"},
    {"id":"5542","name":"First EU treatment for rare sleep-wake disorder","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/CHMP/260099/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-eu-treatment-rare-sleep-wake-disorder_en.pdf"},
    {"id":"5543","name":"Agenda - PRAC draft agenda of meeting 8-11 September 2014","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-09-08T19:00:00Z","last_updated_date":"2014-09-08T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-september-2014_en.pdf"},
    {"id":"5544","name":"COMP meeting report on the review of applications for orphan designation: January 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T16:45:00Z","last_updated_date":"2013-01-11T16:45:00Z","reference_number":"EMA/COMP/797126/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-january-2013_en.pdf"},
    {"id":"5546","name":"Overview of comments received on draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"EMEA/CHMP/EWP/EMEA/198957/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-pharmacokinetics-therapeutic-proteins_en.pdf"},
    {"id":"5547","name":"Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-16T16:13:00Z","last_updated_date":"2018-01-16T16:14:50Z","reference_number":"EMA/9653/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/mifepristone-list-nationally-authorised-medicinal-products-psusa00002060201705_en.pdf"},
    {"id":"5552","name":"Thymi aetheroleum: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:09:21Z","last_updated_date":"1998-05-01T02:09:21Z","reference_number":"EMEA/MRL/411/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/thymi-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"5555","name":"Guideline on quality of oral modified-release products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-07-31T17:00:00Z","last_updated_date":"2014-07-31T17:00:00Z","reference_number":"EMA/CHMP/QWP/428693/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-oral-modified-release-products_en.pdf"},
    {"id":"5556","name":"Committee for Medicinal Products for Human Use (CHMP) - January 2008 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-02-05T01:00:00Z","last_updated_date":"2008-02-05T01:00:00Z","reference_number":"EMEA/37124/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-january-2008-plenary-meeting-monthly-report_en.pdf"},
    {"id":"5559","name":"Committee for medicinal products for veterinary use: Meeting of 12 to 14 September 2006","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-09-14T14:09:21Z","last_updated_date":"2006-09-14T14:09:21Z","reference_number":"EMEA/CVMP/323417/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-12-14-september-2006_en.pdf"},
    {"id":"5560","name":"Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-08T11:00:00Z","last_updated_date":"2016-10-18T11:56:07Z","reference_number":"EMA/178759/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/sertindole-list-nationally-authorised-medicinal-products-psusa00002695201507_en.pdf"},
    {"id":"5562","name":"Opinions on safety variations - Adopted during the CHMP meeting 18-21 June 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T11:33:00Z","last_updated_date":"2012-06-25T11:33:00Z","reference_number":"EMA/CHMP/410511/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-during-chmp-meeting-18-21-june-2012_en.pdf"},
    {"id":"5565","name":"Retinoid Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2017-12-05T16:35:00Z","reference_number":"EMA/PRAC/461927/2016 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"5566","name":"Questions and answers on withdrawal of the marketing authorisation applications for Issarlos (strontium ranelate / cholecalciferol)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/249569/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-applications-issarlos-strontium-ranelate-cholecalciferol_en.pdf"},
    {"id":"5567","name":"EU/3/11/888: Public summary of opinion on orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the treatment of primary myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2013-06-20T13:00:00Z","reference_number":"EMA/COMP/407883/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311888-public-summary-opinion-orphan-designation-n-cyanomethyl-4-2-4-morpholin-4-ylphenylaminopyrimidin-4-ylbenzamide-dihydrochloride-salt-treatment-primary-myelofibrosis_en.pdf"},
    {"id":"5573","name":"Presentation - EudraVigilance and risk management","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-and-risk-management_en.pdf"},
    {"id":"5575","name":"Note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular (CPMP/BPWG/283/00)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-07-25T02:00:00Z","last_updated_date":"2002-07-25T02:00:00Z","reference_number":"EMEA/CPMP/BPWG/283/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-human-normal-immunoglobulin-subcutaneous-and-intramuscular-cpmpbpwg28300_en.pdf"},
    {"id":"5577","name":"EU/3/16/1675: Public summary of opinion on orphan designation: Citric acid monohydrate for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/384853/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161675-public-summary-opinion-orphan-designation-citric-acid-monohydrate-treatment-acute-liver-failure_en.pdf"},
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    {"id":"5586","name":"COMP meeting report on the review of applications for orphan designation: December 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-12-12T19:00:00Z","last_updated_date":"2017-12-12T19:00:00Z","reference_number":"EMA/COMP/790607/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-december-2017_en.pdf"},
    {"id":"5590","name":"Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-13T02:00:00Z","last_updated_date":"2016-10-18T10:40:00Z","reference_number":"EMA/608890/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-sulphate-sodium-sulphate-potassium-sulphate-list-nationally-authorised-medicinal-products-psusa00010239201602_en.pdf"},
    {"id":"5591","name":"Superseded list of references supporting the assessment report on: Betulae folium Betula pendula Roth; Betula pubescens Ehrh., folium (birch leaf)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-05-08T02:09:21Z","last_updated_date":"2015-03-13T01:09:21Z","reference_number":"EMEA/HMPC/207742/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-betulae-folium-betula-pendula-roth-betula-pubescens-ehrh-folium-birch-leaf_en.pdf"},
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    {"id":"5596","name":"Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-01T19:40:05Z","last_updated_date":"2011-07-01T19:40:05Z","reference_number":"EMA/399691/2011","document_url":"https://www.ema.europa.eu/en/documents/other/detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-european-medicines-agency-accordance-article-572-second-subparagraph_en.pdf"},
    {"id":"5597","name":"Public statement on Vibativ: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-05-16T11:35:00Z","last_updated_date":"2018-05-16T11:35:00Z","reference_number":"EMA/198910/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-vibativ-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"5599","name":"Calcitonin Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-19T02:00:00Z","last_updated_date":"2013-07-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/calcitonin-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/calcitonin-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/calcitonin-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/calcitonin-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/calcitonin-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/calcitonin-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/calcitonin-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/calcitonin-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/calcitonin-article-31-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/calcitonin-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/calcitonin-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/calcitonin-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/calcitonin-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/calcitonin-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/calcitonin-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/calcitonin-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/calcitonin-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/calcitonin-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/calcitonin-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/calcitonin-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/calcitonin-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/calcitonin-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"5600","name":"CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 2 summary overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-meeting-2-summary-overview_en.pdf"},
    {"id":"5601","name":"Presentation - Early access tools: accelerated assessment and conditional marketing authorisation (Michael Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-access-tools-accelerated-assessment-and-conditional-marketing-authorisation-michael-berntgen_en.pdf"},
    {"id":"5604","name":"VICH GL31: Safety studies for veterinary drug residues in human food: Repeat-dose (90) toxicity testing - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-16T02:00:00Z","last_updated_date":"2004-06-16T02:00:00Z","reference_number":"CVMP/VICH/484/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl31-safety-studies-veterinary-drug-residues-human-food-repeat-dose-90-toxicity-testing-step-7_en.pdf"},
    {"id":"5605","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Tasigna (nilotinib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/362590/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tasigna-nilotinib_en.pdf"},
    {"id":"5607","name":"Final list of references supporting the assessment of Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/HMPC/39454/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-sideritis-scardica-griseb-sideritis-clandestina-bory-chaub-hayek-sideritis-raeseri-boiss-heldr-sideritis-syriaca-l-herba_en.pdf"},
    {"id":"5609","name":"Working party on Herbal Medicinal Products: Final position paper on the use of Herbal Medicinal Products containing Estragole","type":"position","status":"unknown","consultation_date":"","first_published_date":"2004-03-03T01:00:00Z","last_updated_date":"2004-03-03T01:00:00Z","reference_number":"EMEA/HMPWP/338/03","document_url":"https://www.ema.europa.eu/en/documents/position/working-party-herbal-medicinal-products-final-position-paper-use-herbal-medicinal-products-containing-estragole_en.pdf"},
    {"id":"5610","name":"CHMP summary of positive opinion for Trelegy Ellipta","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T17:39:00Z","last_updated_date":"2017-09-15T17:39:00Z","reference_number":"EMA/CHMP/244744/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trelegy-ellipta_en.pdf"},
    {"id":"5611","name":"Presentation - Delivering the benefits of the new PSUR for healthcare professionals and patients – efficient and effective implementation –A Regulator’s perspective (Kora Doorduyn-van der Stoep)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-delivering-benefits-new-psur-healthcare-professionals-and-patients-efficient-and-effective-implementation-regulators-perspective-kora-doorduyn-van-der-stoep_en.pdf"},
    {"id":"5613","name":"Presentation - Case Study 3 - Applying QbD for a legacy product and achieving real time release testing by a design space approach with supportive PAT and soft sensor based models: Challenges in the implementations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-03T11:40:00Z","last_updated_date":"2014-03-03T11:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-3-applying-qbd-legacy-product-and-achieving-real-time-release-testing-design-space-approach-supportive-pat-and-soft-sensor-based-models-challenges-implementations_en.pdf"},
    {"id":"5615","name":"EU/3/18/1982: Public summary of opinion on orphan designation: N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/64185/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181982-public-summary-opinion-orphan-designation-n-tert-butylcarbamoyl-5-cyano-2-4-difluoromethoxy-11-biphenyl-3-yloxybenzenesulfonamide-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"5616","name":"Methylprednisolone: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-10-01T02:00:00Z","last_updated_date":"1999-10-01T02:00:00Z","reference_number":"EMEA/MRL/703/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/methylprednisolone-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"5617","name":"Final community herbal monograph on Plantago lanceolata L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T01:00:00Z","last_updated_date":"2014-02-10T17:00:00Z","reference_number":"EMA/HMPC/437858/2010 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-plantago-lanceolata-l-folium_en.pdf"},
    {"id":"5618","name":"Domperidone: List of nationally authorised medicinal products - PSUSA/00001158/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T14:00:00Z","last_updated_date":"2016-10-17T19:52:24Z","reference_number":"EMA/706059/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/domperidone-list-nationally-authorised-medicinal-products-psusa00001158201501_en.pdf"},
    {"id":"5623","name":"Presentation - Reporting and evaluation of predictive performance - what is missing in submissions today? (Sue Cole)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reporting-and-evaluation-predictive-performance-what-missing-submissions-today-sue-cole_en.pdf"},
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    {"id":"5672","name":"Agenda - Workshop for Micro, Small and Medium-Sized Enterprises: statistical perspectives in regulatory clinical development programmes","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-12-11T17:40:00Z","last_updated_date":"2015-12-11T17:40:00Z","reference_number":"EMA/350683/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-micro-small-and-medium-sized-enterprises-statistical-perspectives-regulatory-clinical-development-programmes_en.pdf"},
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    {"id":"5675","name":"COMP report to the Commission in relation to Article 10 of Regulation 141/2000 on orphan medicinal products - Annex 1","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-07-25T02:00:00Z","last_updated_date":"2005-07-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/comp-report-commission-relation-article-10-regulation-1412000-orphan-medicinal-products-annex-1_en.pdf"},
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    {"id":"5677","name":"European Medicines Agency recommends approval of pomalidomide for the treatment of multiple myeloma","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T14:00:00Z","last_updated_date":"2013-05-31T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-pomalidomide-treatment-multiple-myeloma_en.pdf"},
    {"id":"5678","name":"Better training tools recommended to support patients using adrenaline auto-injectors","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/411622/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/better-training-tools-recommended-support-patients-using-adrenaline-auto-injectors_en.pdf"},
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    {"id":"5681","name":"Questions and answers on Fortum and associated names (ceftazidime powder for solution for infusion or injection, 250 mg, 500 mg, 1 g, 2 g, 3 g)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/659330/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-fortum-and-associated-names-ceftazidime-powder-solution-infusion-or-injection-250-mg-500-mg-1-g-2-g-3-g_en.pdf"},
    {"id":"5682","name":"Scientific guidance on post-authorisation efficacy studies - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-12-22T12:00:00Z","last_updated_date":"2016-12-22T12:00:00Z","reference_number":"EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/scientific-guidance-post-authorisation-efficacy-studies-first-version_en.pdf"},
    {"id":"5684","name":"Agenda - Workshop on biosimilar monoclonal antibodies and immunogenicity of monoclonal antibodies","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-10-24T11:40:00Z","last_updated_date":"2011-10-24T11:40:00Z","reference_number":"EMA/838645/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-biosimilar-monoclonal-antibodies-and-immunogenicity-monoclonal-antibodies_en.pdf"},
    {"id":"5686","name":"EU/3/01/067: Public summary of positive opinion for orphan designation of thalidomide for the treatment of  multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2018-07-18T02:00:00Z","reference_number":"EMEA/COMP/263/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301067-public-summary-positive-opinion-orphan-designation-thalidomide-treatment-multiple-myeloma_en.pdf"},
    {"id":"5687","name":"Annual list of specific contracts based on framework contracts - 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-28T17:00:00Z","last_updated_date":"2017-06-28T17:00:00Z","reference_number":"EMA/425055/2016","document_url":"https://www.ema.europa.eu/en/documents/other/annual-list-specific-contracts-based-framework-contracts-2016_en.pdf"},
    {"id":"5691","name":"Presentation - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting - PCWP plenary: COMP update June 2016 (Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-pcwp-plenary-comp-update-june-2016-daniel-oconnor_en.pdf"},
    {"id":"5692","name":"Committee for medicinal products for veterinary use: Meeting of 13-15 May 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-05-16T02:09:21Z","last_updated_date":"2008-05-16T02:09:21Z","reference_number":"EMEA/CVMP/232903/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-13-15-may-2008_en.pdf"},
    {"id":"5694","name":"Presentation - Improving and harmonising the Summary of Product Characteristics and the conditions for use of old antibacterials (Radu Botgros)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-improving-and-harmonising-summary-product-characteristics-and-conditions-use-old-antibacterials-radu-botgros_en.pdf"},
    {"id":"5697","name":"Ketamine: List of nationally authorised medicinal products - PSUSA/00001804/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-10-17T19:03:13Z","reference_number":"EMA/580856/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketamine-list-nationally-authorised-medicinal-products-psusa00001804201512_en.pdf"},
    {"id":"5698","name":"EU/3/05/308: Public summary of positive opinion for orphan designation of sapropterin for the treatment of hyperphenylalaninemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T00:00:00Z","last_updated_date":"2011-03-29T01:00:00Z","reference_number":"EMEA/COMP/247606/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305308-public-summary-positive-opinion-orphan-designation-sapropterin-treatment-hyperphenylalaninemia_en.pdf"},
    {"id":"5703","name":"EU/3/16/1679: Public summary of opinion on orphan designation: Eflornithine for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/387500/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161679-public-summary-opinion-orphan-designation-eflornithine-treatment-glioma_en.pdf"},
    {"id":"5704","name":"Agenda - Joint HMA/EMEA meeting on promoting prudent and responsible use of antimicrobials in veterinary medicine","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:09:21Z","last_updated_date":"2009-05-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-hmaemea-meeting-promoting-prudent-and-responsible-use-antimicrobials-veterinary-medicine_en.pdf"},
    {"id":"5706","name":"Minutes - Healthcare Professionals Working Group (HCPWG) meeting 27 Feb 2013","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/255634/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-healthcare-professionals-working-group-hcpwg-meeting-27-feb-2013_en.pdf"},
    {"id":"5707","name":"Information for the package leaflet for fragrances containing allergens used as excipients in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/273718/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/information-package-leaflet-fragrances-containing-allergens-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"5708","name":"CHMP summary of positive opinion for Bexsero","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"EMA/CHMP/669278/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bexsero_en.pdf"},
    {"id":"5713","name":"Annex 1 - Active substance master file (ASMF) assessment report template - Restricted part rev. 06.17","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-07-03T16:30:04Z","last_updated_date":"2017-07-03T16:30:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-1-active-substance-master-file-asmf-assessment-report-template-restricted-part-rev-0617_en.docx"},
    {"id":"5714","name":"EU/3/12/1048: Public summary of opinion on orphan designation: Mixture of two allogeneic human pancreatic-cancer cell lines stably transduced with a retroviral vector encoding the murine alpha-(1,3)-galactosyltransferase...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2018-01-23T01:00:00Z","reference_number":"EMA/COMP/625102/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121048-public-summary-opinion-orphan-designation-mixture-two-allogeneic-human-pancreatic-cancer-cell-lines-stably-transduced-retroviral-vector-encoding-murine-alpha-13-galactosyltransferase_en.pdf"},
    {"id":"5716","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  Rhucin : Common name: recombinant human C1 inhibitor","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-03-19T00:09:21Z","last_updated_date":"2008-03-19T00:09:21Z","reference_number":"EMEA/CHMP/143105/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-rhucin-common-name-recombinant-human-c1-inhibitor_en.pdf"},
    {"id":"5717","name":"Public statement on Daronrix: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T12:00:00Z","last_updated_date":"2013-07-02T12:00:00Z","reference_number":"EMA/670070/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-daronrix-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"5718","name":"Revised rules of procedure of the Management Board","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2021-10-11T15:29:00Z","reference_number":"EMA/MB/115339/2004/en/Rev.8","document_url":"https://www.ema.europa.eu/en/documents/other/revised-rules-procedure-management-board_en.pdf"},
    {"id":"5720","name":"Committee international des pharmaciens homeopathes (CIPH) - Homeopathic workshop - Introduction","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/committee-international-des-pharmaciens-homeopathes-ciph-homeopathic-workshop-introduction_en.pdf"},
    {"id":"5723","name":"Annual report of the good clinical practice inspections working group 2009","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/INS/GCP/782679/2009","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-good-clinical-practice-inspections-working-group-2009_en.pdf"},
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    {"id":"5746","name":"Presentation - Referrals update from the regulators (Almath Spooner and Tania Teixeira)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-referrals-update-regulators-almath-spooner-and-tania-teixeira_en.pdf"},
    {"id":"5749","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n18-21 February 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T00:09:21Z","last_updated_date":"2008-02-21T00:09:21Z","reference_number":"EMEA/CHMP/87277/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-18-21-february-2008_en.pdf"},
    {"id":"5750","name":"CHMP summary of positive opinion for Intrarosa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2017-11-10T01:00:00Z","reference_number":"EMA/CHMP/724429/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-intrarosa_en.pdf"},
    {"id":"5751","name":"Agenda - PRAC draft agenda of meeting 28 November - 1 December 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-11-28T18:18:00Z","last_updated_date":"2016-11-28T18:18:00Z","reference_number":"EMA/PRAC/724425/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-28-november-1-december-2016_en.pdf"},
    {"id":"5754","name":"Scientific recommendation on classification of advanced-therapy medicinal products: A mixture of autologous dendritic cells pulsed with a non-structural-3 protein fragment of the hepatitis-C virus and activated T-cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T13:30:00Z","last_updated_date":"2013-03-08T13:30:00Z","reference_number":"EMA/50963/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-mixture-autologous-dendritic-cells-pulsed-non-structural-3-protein-fragment-hepatitis-c-virus-and-activated-t-cells_en.pdf"},
    {"id":"5757","name":"Presentation - The role of modelling/simulation in paediatric population (J. Karres, N. Benda, J. Standing)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-modellingsimulation-paediatric-population-j-karres-n-benda-j-standing_en.pdf"},
    {"id":"5758","name":"Withdrawal assessment report for Oncept Melanoma","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-02-24T11:00:00Z","last_updated_date":"2015-02-24T11:00:00Z","reference_number":"EMA/CVMP/311730/2014","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-oncept-melanoma_en.pdf"},
    {"id":"5759","name":"Withdrawal assessment report for Zunrisa","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/615816/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zunrisa_en.pdf"},
    {"id":"5760","name":"EU/3/12/1000: Public summary of opinion on orphan designation: Polyinosine-polycytidylic acid coupled with the polycationic polyethyleneimine for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2013-09-23T17:00:00Z","reference_number":"EMA/COMP/286701/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121000-public-summary-opinion-orphan-designation-polyinosine-polycytidylic-acid-coupled-polycationic-polyethyleneimine-treatment-pancreatic-cancer_en.pdf"},
    {"id":"5762","name":"Meeting highlights from the Paediatric Committee: 1 - 2 August 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-08-06T02:00:00Z","last_updated_date":"2007-08-06T02:00:00Z","reference_number":"EMEA/354317/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-1-2-august-2007_en.pdf"},
    {"id":"5763","name":"Presentation - The staggered two-step approach for treatments with profound effect on immunity (Gavin Giovannoni)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-staggered-two-step-approach-treatments-profound-effect-immunity-gavin-giovannoni_en.pdf"},
    {"id":"5764","name":"Revised Public Statement on Etanercept (Enbrel) - Serious hematological reactions and demyelination disorders","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-10-03T02:00:00Z","last_updated_date":"2000-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/revised-public-statement-etanercept-enbrel-serious-hematological-reactions-and-demyelination-disorders_en.pdf"},
    {"id":"5765","name":"EU/3/15/1588: Public summary of opinion on orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea for the treatme...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2023-04-04T12:39:00Z","reference_number":"EMA/COMP/793612/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151588-public-summary-opinion-orphan-designation-r-1-1-4-acetoxy-33-dimethyl-2-oxo-butyl-2-oxo-5-pyridin-2-yl-23-dihydro-1h-benzoe14diazepin-3-yl-3-3-methylamino-phenyl-urea-treatme_en.pdf"},
    {"id":"5766","name":"EU/3/13/1111: Public summary of opinion on orphan designation:\n\nGevokizumab for the treatment of chronic non-infectious uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-05T02:00:00Z","last_updated_date":"2018-07-18T02:00:00Z","reference_number":"EMA/COMP/105735/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131111-public-summary-opinion-orphan-designation-gevokizumab-treatment-chronic-non-infectious-uveitis_en.pdf"},
    {"id":"5768","name":"EU/3/07/524: Public summary of positive opinion for orphan designation of (R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl] phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole for the treatment of tuber...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2014-06-18T13:30:00Z","reference_number":"EMEA/COMP/578275/2007 Rev.","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307524-public-summary-positive-opinion-orphan-designation-r-2-methyl-6-nitro-2-4-4-4-trifluoromethoxyphenoxypiperidin-1-yl-phenoxymethyl-23-dihydroimidazo21-boxazole-treatment-tuber_en.pdf"},
    {"id":"5769","name":"Presentation - Update on ADVANCE project follow-up of EMA workshop of 13 November 2013 (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-advance-project-follow-ema-workshop-13-november-2013-peter-arlett_en.pdf"},
    {"id":"5772","name":"Questions and answers on refusal of the marketing authorisation for Xeljanz","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/248755/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-xeljanz_en.pdf"},
    {"id":"5774","name":"CHMP summary of positive opinion for Daptomycin Hospira","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T13:00:00Z","last_updated_date":"2017-01-27T13:00:00Z","reference_number":"EMA/CHMP/37961/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-daptomycin-hospira_en.pdf"},
    {"id":"5775","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 17-19 July 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-07-29T16:00:00Z","last_updated_date":"2013-07-29T16:00:00Z","reference_number":"EMA/435730/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-17-19-july-2013_en.pdf"},
    {"id":"5779","name":"ICH: M 5 EWG: Units and measurements controlled vocabulary - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-05-01T02:00:00Z","last_updated_date":"2005-05-01T02:00:00Z","reference_number":"CHMP/ICH/175818/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-5-ewg-units-and-measurements-controlled-vocabulary-step-5_en.pdf"},
    {"id":"5781","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 October 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"EMA/CVMP/585227/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-october-2013_en.pdf"},
    {"id":"5783","name":"Assessment report for Tienam and associated names","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T01:00:00Z","last_updated_date":"2012-02-20T01:00:00Z","reference_number":"EMA/513740/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-tienam-and-associated-names_en.pdf"},
    {"id":"5785","name":"Public Statement on Valdyn (valdecoxib) Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-08-23T02:09:21Z","last_updated_date":"2004-08-23T02:09:21Z","reference_number":"EMEA/20783/04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-valdyn-valdecoxib-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"5787","name":"Agenda - PRAC draft agenda of meeting 7-10 October 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-10-08T18:55:00Z","last_updated_date":"2013-10-14T14:30:00Z","reference_number":"EMA/PRAC/610367/2013 Corr","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-7-10-october-2013_en.pdf"},
    {"id":"5789","name":"Presentation - Comments and proposals on the results of the EFPIA survey","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comments-and-proposals-results-efpia-survey_en.pdf"},
    {"id":"5790","name":"CVMP guideline on pharmacovigilance of veterinary medicinal products - Guidance on procedures for marketing authorisation holders","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-07-15T02:00:00Z","last_updated_date":"2007-07-15T02:00:00Z","reference_number":"EMEA/CVMP/183/96 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/cvmp-guideline-pharmacovigilance-veterinary-medicinal-products-guidance-procedures-marketing-authorisation-holders_en.pdf"},
    {"id":"5793","name":"CHMP summary of positive opinion for Stribild","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T13:00:00Z","last_updated_date":"2013-03-22T13:00:00Z","reference_number":"EMA/CHMP/158160/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-stribild_en.pdf"},
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    {"id":"5796","name":"EU/3/06/416: Public summary of positive opinion for orphan designation of antisense oligonucleotide 5'-d[P-Thio] (CCCTG CTCCC CCCTG GCTCC)-3' for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMEA/COMP/173924/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306416-public-summary-positive-opinion-orphan-designation-antisense-oligonucleotide-5-dp-thio-ccctg-ctccc-ccctg-gctcc-3-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"5797","name":"CHMP statistics: March 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-march-2017_en.pdf"},
    {"id":"5802","name":"ICH: E 2 F: Development safety update report - Step 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2010-10-18T02:00:00Z","reference_number":"EMA/CHMP/ICH/309348/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-2-f-development-safety-update-report-step-3_en.pdf"},
    {"id":"5803","name":"Agenda and registration form  - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-23T13:00:00Z","last_updated_date":"2017-11-23T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-london_en.pdf"},
    {"id":"5804","name":"Agenda - European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) - 2nd annual network meeting 2012 - Agenda and summary","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T12:17:00Z","last_updated_date":"2012-03-29T12:27:00Z","reference_number":"EMA/965820/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-surveillance-veterinary-antimicrobial-consumption-esvac-2nd-annual-network-meeting-2012-agenda-and-summary_en.pdf"},
    {"id":"5807","name":"Presentation - Types 2 and 3 SMA: Industry perspective (Omar Khwaja)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-types-2-and-3-sma-industry-perspective-omar-khwaja_en.pdf"},
    {"id":"5813","name":"Presentation - 1995 – 2015: 20 years of European Medicines Agency (Marie-Agnes Heine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-1995-2015-20-years-european-medicines-agency-marie-agnes-heine_en.pdf"},
    {"id":"5815","name":"VICH GL24: Guideline on pharmacovigilance of veterinary medicinal products -Management of adverse event reports (AERS)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-03-17T01:00:00Z","last_updated_date":"2013-12-16T19:00:00Z","reference_number":"EMA/CVMP/VICH/547/2000","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl24-guideline-pharmacovigilance-veterinary-medicinal-products-management-adverse-event-reports-aers_en.pdf"},
    {"id":"5816","name":"Questions and answers on the withdrawal of the marketing authorisation application for OraNera","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-03-22T01:00:00Z","last_updated_date":"2013-03-22T01:00:00Z","reference_number":"EMA/179232/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oranera_en.pdf"},
    {"id":"5817","name":"EnprEMA self-assessment form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T17:45:00Z","last_updated_date":"2014-03-21T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/enprema-self-assessment-form_en.pdf"},
    {"id":"5819","name":"HPV vaccines - Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-13T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMA/454979/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/hpv-vaccines-article-20-procedure-review-started_en.pdf"},
    {"id":"5823","name":"EU/3/13/1206: Public summary of opinion on orphan designation: Synthetic 12 amino acid peptide designed after subcommissural organ-spondin for the treatment of spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-12-02T01:00:00Z","last_updated_date":"2013-12-02T01:00:00Z","reference_number":"EMA/COMP/631492/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131206-public-summary-opinion-orphan-designation-synthetic-12-amino-acid-peptide-designed-after-subcommissural-organ-spondin-treatment-spinal-cord-injury_en.pdf"},
    {"id":"5824","name":"CHMP summary of positive opinion for Prolia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/776168/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-prolia_en.pdf"},
    {"id":"5826","name":"Highlights from the 13th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation – 20 March 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-05-07T15:13:00Z","last_updated_date":"2018-05-07T15:13:00Z","reference_number":"EMA/181781/2018","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-13th-ema-industry-platform-meeting-operation-eu-pharmacovigilance-legislation-20-march-2018_en.pdf"},
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    {"id":"5828","name":"Work instructions for using the Agency's Twitter channel","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2014-02-28T10:45:00Z","reference_number":"WIN/EMA/0123","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-using-agencys-twitter-channel_en.pdf"},
    {"id":"5830","name":"Adrenaline auto-injectors Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"EMA/CHMP/225801/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/adrenaline-auto-injectors-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"5831","name":"Response to public comments received on the inventory of paediatric therapeutic needs: gastroenterology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-28T17:20:00Z","last_updated_date":"2015-10-28T17:20:00Z","reference_number":"EMA/PDCO/470078/2015","document_url":"https://www.ema.europa.eu/en/documents/other/response-public-comments-received-inventory-paediatric-therapeutic-needs-gastroenterology_en.pdf"},
    {"id":"5833","name":"EU/3/07/463: Public summary of positive opinion for orphan designation of pyridoxalated hemoglobin polyoxyethylene for the treatment of cardiogenic shock","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/165527/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307463-public-summary-positive-opinion-orphan-designation-pyridoxalated-hemoglobin-polyoxyethylene-treatment-cardiogenic-shock_en.pdf"},
    {"id":"5834","name":"Presentation - Optical coherence tomography: A role in monitoring multiple sclerosis (Celia Oreja-Guevara)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optical-coherence-tomography-role-monitoring-multiple-sclerosis-celia-oreja-guevara_en.pdf"},
    {"id":"5835","name":"Questions and answers on Kantos Master and associated names (beclomethasone dipropionate / formoterol fumarate, inhaler)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-05-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-kantos-master-and-associated-names-beclomethasone-dipropionate-formoterol-fumarate-inhaler_sv.pdf"}},
    {"id":"5838","name":"Annual report of the European Medicines Agency 2005","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2006-03-09T00:09:21Z","last_updated_date":"2006-03-09T00:09:21Z","reference_number":"EMEA/MB/63019/2006","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2005_en.pdf"},
    {"id":"5840","name":"CHMP post-authorisation summary of positive opinion for Erbitux","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T11:14:00Z","last_updated_date":"2011-11-18T11:14:00Z","reference_number":"EMA/882977/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-erbitux_en.pdf-0"},
    {"id":"5842","name":"List of networks members","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-21T02:09:21Z","last_updated_date":"2009-04-21T02:09:21Z","reference_number":"EMEA/248834/2009","document_url":"https://www.ema.europa.eu/en/documents/other/list-networks-members_en.pdf"},
    {"id":"5846","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-11-23T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"EMA/545915/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"5847","name":"Final Community herbal monograph on Origanum dictamnus L., herba - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-08-05T02:00:00Z","last_updated_date":"2014-02-10T16:50:00Z","reference_number":"EMA/HMPC/200429/2012 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-origanum-dictamnus-l-herba-first-version_en.pdf"},
    {"id":"5849","name":"Presentation - Wacean: a patient-driven innovative tool for data capture (Julian Isla)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-wacean-patient-driven-innovative-tool-data-capture-julian-isla_en.pdf"},
    {"id":"5850","name":"Oxaliplatin: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00002229/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T01:00:00Z","last_updated_date":"2016-10-18T13:02:21Z","reference_number":"EMA/190948/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxaliplatin-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002229201504_en.pdf"},
    {"id":"5851","name":"Presentation - Treatment of sepsis (Radu Botgros)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-treatment-sepsis-radu-botgros_en.pdf"},
    {"id":"5853","name":"Ad hoc working party on Herbal Medicinal Products:  Final comments and proposals for revision of part 4 of annex to Council Directive 75/318/EEC of 20 May 1975 'clinical documentation'","type":"other","status":"unknown","consultation_date":"","first_published_date":"1998-09-17T02:00:00Z","last_updated_date":"1998-09-17T02:00:00Z","reference_number":"EMEA/HMPWP/13/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-party-herbal-medicinal-products-final-comments-and-proposals-revision-part-4-annex-council-directive-75318eec-20-may-1975-clinical-documentation_en.pdf"},
    {"id":"5854","name":"Presentation - EPAR summaries: Introduction to review by patients and consumers (Paul Blake)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-epar-summaries-introduction-review-patients-and-consumers-paul-blake_en.pdf"},
    {"id":"5855","name":"Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-05T15:28:00Z","last_updated_date":"2017-12-05T15:31:00Z","reference_number":"EMA/787886/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-list-nationally-authorised-medicinal-products-psusa00010488201705_en.pdf"},
    {"id":"5856","name":"Overview of comments received on 'Reflection paper on classification of advanced therapy medicinal products'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-06-17T14:00:00Z","last_updated_date":"2015-06-17T14:00:00Z","reference_number":"EMA/CAT/224106/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-classification-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"5857","name":"Committee for medicinal products for human use, summary of positive opinion for Nymusa","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/212696/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-nymusa_en.pdf"},
    {"id":"5858","name":"Guidelines and concept papers adopted during the CHMP meeting 23-26 March 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T18:00:00Z","last_updated_date":"2015-04-09T18:00:00Z","reference_number":"EMA/CHMP/27955/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-23-26-march-2015_en.pdf"},
    {"id":"5859","name":"Letter to Sane Vax Inc. from the Committee for Medicinal Products for Human Use (CHMP) regarding Gardasil","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T16:00:00Z","last_updated_date":"2011-09-23T16:00:00Z","reference_number":"EMA/771987/2011","document_url":"https://www.ema.europa.eu/en/documents/other/letter-sane-vax-inc-committee-medicinal-products-human-use-chmp-regarding-gardasil_en.pdf"},
    {"id":"5860","name":"Tricaine mesilate: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/586/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tricaine-mesilate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"5861","name":"EU/3/16/1800: Public summary of opinion on orphan designation: Dantrolene sodium for the treatment of Wolfram syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/756214/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161800-public-summary-opinion-orphan-designation-dantrolene-sodium-treatment-wolfram-syndrome_en.pdf"},
    {"id":"5864","name":"Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Parecoxib, Rofecoxib or Valdecoxib International Non-Proprietary Name (INN): Rofecoxib: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-04-30T02:08:21Z","last_updated_date":"2004-04-30T02:08:21Z","reference_number":"EMEA/CPMP/1749/04","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-all-medicinal-products-containing-celecoxib-etoricoxib-parecoxib-rofecoxib-or-valdecoxib-international-non-proprietary-name-inn-rofecoxib-background-information_en.pdf"},
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    {"id":"5867","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose tissue-derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T16:30:00Z","last_updated_date":"2017-10-23T16:30:00Z","reference_number":"EMA/561787/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-adipose-tissue-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"5870","name":"EU/3/08/552: Public summary of positive opinion for orphan designation of pegylated recombinant factor VIIa for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMEA/COMP/204660/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308552-public-summary-positive-opinion-orphan-designation-pegylated-recombinant-factor-viia-treatment-haemophilia-b_en.pdf"},
    {"id":"5871","name":"Presentation - The importance of clarity in relationships and transparency, Henry FItt","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-importance-clarity-relationships-and-transparency-henry-fitt_en.pdf"},
    {"id":"5872","name":"European Medicines Agency reveals new structure","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-09-16T12:00:00Z","last_updated_date":"2013-09-16T12:00:00Z","reference_number":"EMA/549590/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-reveals-new-structure_en.pdf"},
    {"id":"5874","name":"Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-07-07T02:00:00Z","reference_number":"EMA/CVMP/779112/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-eprinomectin_en.pdf"},
    {"id":"5875","name":"Withdrawal assessment report for Gastromotal","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-03-10T01:00:00Z","last_updated_date":"2008-03-10T01:00:00Z","reference_number":"EMEA/111865/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-gastromotal_en.pdf"},
    {"id":"5876","name":"EU/3/12/1069: Public summary of opinion on orphan designation: Adeno-associated viral vector encoding an inducible short hairpin RNA targeting claudin-5 (prior to administration of 17-dimethylaminoethylamino-17-demethocy...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2016-10-21T02:00:00Z","reference_number":"EMA/COMP/655660/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121069-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-encoding-inducible-short-hairpin-rna-targeting-claudin-5-prior-administration-17-dimethylaminoethylamino-17-demethocy_en.pdf"},
    {"id":"5877","name":"Overview of comments received on draft guideline on the development medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/242067/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-development-medicinal-substances-contained-drug-eluting-medicinal-substance-eluting-coronary-stents_en.pdf"},
    {"id":"5879","name":"Presentation - PCWP – all eligible meeting: COMP update November 2017 (D. O'Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:50:00Z","last_updated_date":"2017-12-11T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwp-all-eligible-meeting-comp-update-november-2017-d-oconnor_en.pdf"},
    {"id":"5880","name":"Presentation - Overview of 3-years of operation (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-29T18:30:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-3-years-operation-peter-arlett_en.pdf"},
    {"id":"5882","name":"Committee for Proprietary Medicinal Products (CPMP) 32nd plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-11-20T01:00:00Z","last_updated_date":"1997-11-20T01:00:00Z","reference_number":"CPMP/1056/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-32nd-plenary-meeting_en.pdf"},
    {"id":"5885","name":"Strenzen 500/125mg/g Article-33(4) referral - Annex I-III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-19T02:00:00Z","last_updated_date":"2013-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/strenzen-500125mgg-article-334-referral-annex-i-iii_sv.pdf"}},
    {"id":"5887","name":"Overview of comments received on Community herbal monograph on Filipendula ulmaria (L.) Maxim., herba - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-09-29T02:00:00Z","last_updated_date":"2011-09-29T02:00:00Z","reference_number":"EMA/HMPC/326670/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-filipendula-ulmaria-l-maxim-herba-first-version_en.pdf"},
    {"id":"5888","name":"Paromomycin (Extension to all food producing species): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/MRL/825/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/paromomycin-extension-all-food-producing-species-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"5892","name":"Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T17:08:00Z","last_updated_date":"2017-10-26T17:21:00Z","reference_number":"EMA/715509/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00010298201703_en.pdf"},
    {"id":"5893","name":"EU/3/05/344: Public summary of positive opinion for orphan designation of vandetanib for the treatment of medullary thyroid carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-08-08T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/20891/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305344-public-summary-positive-opinion-orphan-designation-vandetanib-treatment-medullary-thyroid-carcinoma_en.pdf"},
    {"id":"5894","name":"EU/03/11/926: Public summary of opinion on orphan designation: Recombinant human minibody against complement component C5 for the treatment of primary membranoproliferative glomerulonephritis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2014-01-22T16:00:00Z","reference_number":"EMA/COMP/791225/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu0311926-public-summary-opinion-orphan-designation-recombinant-human-minibody-against-complement-component-c5-treatment-primary-membranoproliferative-glomerulonephritis_en.pdf"},
    {"id":"5896","name":"Table of recommendations - Multiple sclerosis workshop","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"EMA/651859/2017","document_url":"https://www.ema.europa.eu/en/documents/other/table-recommendations-multiple-sclerosis-workshop_en.pdf"},
    {"id":"5897","name":"EU/3/16/1666: Public summary of opinion on orphan designation: Rimiducid for treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2022-04-07T02:00:00Z","reference_number":"EMA/COMP/308001/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161666-public-summary-opinion-orphan-designation-rimiducid-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"5898","name":"Final European Union herbal monograph on Ginkgo biloba L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-04-08T02:00:00Z","last_updated_date":"2015-04-08T02:00:00Z","reference_number":"EMA/HMPC/321097/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-ginkgo-biloba-l-folium_en.pdf"},
    {"id":"5900","name":"CHMP summary of positive opinion for Jakavi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T02:00:00Z","last_updated_date":"2012-04-20T02:00:00Z","reference_number":"EMA/CHMP/231626/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-jakavi_en.pdf"},
    {"id":"5902","name":"Presentation - UK’s withdrawal from the EU - preparedness activities update (T. Humphreys, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-uks-withdrawal-eu-preparedness-activities-update-t-humphreys-ema_en.pdf"},
    {"id":"5903","name":"Semler Article-31 referral – Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T15:00:00Z","last_updated_date":"2016-11-17T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/semler-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/semler-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/semler-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/semler-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/semler-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/semler-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/semler-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/semler-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/semler-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/semler-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/semler-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/semler-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/semler-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/semler-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/semler-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/semler-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/semler-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/semler-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/semler-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/semler-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/semler-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/semler-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/semler-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"5904","name":"EU/3/06/369: Public summary of positive opinion for orphan designation of\n\nbilayer engineered skin composed of keratinocytes from the patient (autologous) and fibroblasts from a donor (allogeneic) embedded in a plasma ma...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2015-03-11T01:00:00Z","reference_number":"EMEA/COMP/126215/2006 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306369-public-summary-positive-opinion-orphan-designation-bilayer-engineered-skin-composed-keratinocytes-patient-autologous-and-fibroblasts-donor-allogeneic-embedded-plasma-ma_en.pdf"},
    {"id":"5905","name":"European Medicines Agency starts review of Protelos / Osseor","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-10-20T17:58:59Z","last_updated_date":"2011-10-20T17:58:59Z","reference_number":"EMA/CHMP/827880/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-protelos-osseor_en.pdf"},
    {"id":"5910","name":"Meeting highlights from the Paediatric Committee held by written procedure:19 - 21 August 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-08-25T02:00:00Z","last_updated_date":"2009-08-25T02:00:00Z","reference_number":"EMEA/PDCO/518054/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-held-written-procedure19-21-august-2009_en.pdf"},
    {"id":"5912","name":"Guideline on specifications test procedures and acceptance criteria for herbal substances herbal preparations and herbal medicinal products traditional herbal medicinal products - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-09-28T12:55:00Z","last_updated_date":"2011-09-28T12:55:00Z","reference_number":"EMA/HMPC/162241/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-specifications-test-procedures-and-acceptance-criteria-herbal-substances-herbal-preparations-and-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf"},
    {"id":"5920","name":"EU/3/15/1443: Public summary of opinion on orphan designation: Recombinant human glutamate oxaloacetate transaminase 1 for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2021-04-07T14:33:00Z","reference_number":"EMA/COMP/26647/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151443-public-summary-opinion-orphan-designation-recombinant-human-glutamate-oxaloacetate-transaminase-1-treatment-glioma_en.pdf"},
    {"id":"5921","name":"Final list of references supporting the assessment of Carum carvi L.,fructus and Carum carvi L., aetheroleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/HMPC/242200/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-carum-carvi-lfructus-and-carum-carvi-l-aetheroleum_en.pdf"},
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    {"id":"5924","name":"Docetaxel Teva Generics - Article 29 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-07-03T02:00:00Z","last_updated_date":"2012-07-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/docetaxel-teva-generics-article-29-referral-annex-ii_sv.pdf"}},
    {"id":"5928","name":"Position paper on viral safety of Oral Poliovirus Vaccine (OPV)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-05-28T02:00:00Z","last_updated_date":"1998-05-28T02:00:00Z","reference_number":"CPMP/BWP/972/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-viral-safety-oral-poliovirus-vaccine-opv_en.pdf"},
    {"id":"5931","name":"Presentation - The place for treatments of associated neuropsychiatric and other symptoms in Alzheimer's disease and other dementias - patient and carers' perspective (Mary-Frances Morris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-place-treatments-associated-neuropsychiatric-and-other-symptoms-alzheimers-disease-and-other-dementias-patient-and-carers-perspective-mary-frances-morris_en.pdf"},
    {"id":"5932","name":"EU/3/15/1533: Public summary of opinion on orphan designation: Human allogeneic bone-marrow-derived osteoblastic cells for the treatment of osteogenesis imperfecta","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/495514/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151533-public-summary-opinion-orphan-designation-human-allogeneic-bone-marrow-derived-osteoblastic-cells-treatment-osteogenesis-imperfecta_en.pdf"},
    {"id":"5933","name":"Lactulose: List of nationally authorised medicinal products - PSUSA/00001821/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-16T15:20:00Z","last_updated_date":"2017-01-16T15:23:02Z","reference_number":"EMA/28658/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/lactulose-list-nationally-authorised-medicinal-products-psusa00001821201605_en.pdf"},
    {"id":"5934","name":"CPMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-02-20T01:00:00Z","last_updated_date":"2003-02-20T01:00:00Z","reference_number":"EMEA/CPMP/BWP/2879/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/cpmp-position-statement-creutzfeldt-jakob-disease-and-plasma-derived-and-urine-derived-medicinal-products-first-version_en.pdf"},
    {"id":"5936","name":"CVMP post-authorisation summary of positive opinion for Improvac","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"EMA/CVMP/559849/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-improvac_en.pdf"},
    {"id":"5938","name":"Development of non-substantially manipulated cell-based advanced therapy medicinal products: flexibility introduced via the application of the risk-based approach","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-07-03T19:36:00Z","last_updated_date":"2017-07-03T19:36:00Z","reference_number":"EMA/CAT/216556/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/development-non-substantially-manipulated-cell-based-advanced-therapy-medicinal-products-flexibility-introduced-application-risk-based-approach_en.pdf"},
    {"id":"5940","name":"PDCO meeting highlights 15-17 October 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-10-24T02:00:00Z","last_updated_date":"2008-10-24T02:00:00Z","reference_number":"EMEA/PDCO/552811/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-15-17-october-2008_en.pdf"},
    {"id":"5941","name":"ICH guideline E16: Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T01:00:00Z","reference_number":"EMA/CHMP/ICH/380636/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e16-genomic-biomarkers-related-drug-response-context-structure-and-format-qualification-submissions-step-5_en.pdf"},
    {"id":"5942","name":"Tavanic - Article 30 referral - Annex III (tablets)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T15:00:00Z","last_updated_date":"2012-09-12T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tavanic-article-30-referral-annex-iii-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tavanic-article-30-referral-annex-iii-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tavanic-article-30-referral-annex-iii-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tavanic-article-30-referral-annex-iii-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tavanic-article-30-referral-annex-iii-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tavanic-article-30-referral-annex-iii-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tavanic-article-30-referral-annex-iii-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tavanic-article-30-referral-annex-iii-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tavanic-article-30-referral-annex-iii-tablets_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tavanic-article-30-referral-annex-iii-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tavanic-article-30-referral-annex-iii-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tavanic-article-30-referral-annex-iii-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tavanic-article-30-referral-annex-iii-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tavanic-article-30-referral-annex-iii-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tavanic-article-30-referral-annex-iii-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tavanic-article-30-referral-annex-iii-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tavanic-article-30-referral-annex-iii-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tavanic-article-30-referral-annex-iii-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tavanic-article-30-referral-annex-iii-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tavanic-article-30-referral-annex-iii-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tavanic-article-30-referral-annex-iii-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tavanic-article-30-referral-annex-iii-tablets_sv.pdf"}},
    {"id":"5944","name":"CHMP post-authorisation summary of positive opinion for Opdivo","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/231518/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo_en.pdf"},
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    {"id":"5950","name":"Presentation - How does the EU Regulatory Network communicates about risk minimisation? (Viola Macolić-Š arinić, Juan Garcia-Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-does-eu-regulatory-network-communicates-about-risk-minimisation-viola-macolia-s-arinia-juan-garcia-burgos_en.pdf"},
    {"id":"5951","name":"Superseded assessment report on Verbascum thapsus L., V. densiflorum Bertol; V. phlomoides L., flos with traditional use","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/HMPC/395206/2007 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-verbascum-thapsus-l-v-densiflorum-bertol-v-phlomoides-l-flos-traditional-use_en.pdf"},
    {"id":"5952","name":"Update on the implementation of the EU Telematics strategy","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/724730/2009","document_url":"https://www.ema.europa.eu/en/documents/report/update-implementation-eu-telematics-strategy_en.pdf"},
    {"id":"5954","name":"Presentation - Joint industry presentation: One-year industry experience – Eligibility to PRIME (Simon Bennet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-07T02:00:00Z","last_updated_date":"2017-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-industry-presentation-one-year-industry-experience-eligibility-prime-simon-bennet_en.pdf"},
    {"id":"5957","name":"EU/3/09/663: Public summary of positive opinion for orphan designation of adeno-associated viral vector containing modified U1 snRNA for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"EMA/COMP/448951/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309663-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-containing-modified-u1-snrna-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"5958","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the June 2010 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-06-08T02:00:00Z","last_updated_date":"2010-06-24T02:00:00Z","reference_number":"EMA/COMP/342322/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-june-2010-meeting_en.pdf"},
    {"id":"5961","name":"Presentation - Changing diagnostic criteria for Alzheimer’s disease - impact on clinical trials (Bruno Dubois)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-changing-diagnostic-criteria-alzheimers-disease-impact-clinical-trials-bruno-dubois_en.pdf"},
    {"id":"5963","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - January 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-01-31T01:00:00Z","last_updated_date":"2008-01-31T01:00:00Z","reference_number":"EMEA/59971/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-january-2008_en.pdf"},
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    {"id":"5999","name":"Beta-alanine: List of nationally authorised medicinal products - PSUSA/00010510/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-29T17:55:00Z","last_updated_date":"2017-09-29T17:56:31Z","reference_number":"EMA/635953/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/beta-alanine-list-nationally-authorised-medicinal-products-psusa00010510201701_en.pdf"},
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    {"id":"6005","name":"Aclasta: further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T13:00:00Z","last_updated_date":"2015-03-27T13:00:00Z","reference_number":"EMA/206916/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/aclasta-further-measures-minimise-risk-osteonecrosis-jaw-bisphosphonate-medicine_en.pdf"},
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    {"id":"6017","name":"European Medicines Agency recommends changes to the use of metoclopramide","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T12:00:00Z","last_updated_date":"2013-07-26T12:00:00Z","reference_number":"EMA/443003/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-changes-use-metoclopramide_en.pdf"},
    {"id":"6018","name":"CHMP summary of positive opinion for Xalkori","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-07-20T02:00:00Z","last_updated_date":"2012-07-20T02:00:00Z","reference_number":"EMA/CHMP/453868/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xalkori_en.pdf"},
    {"id":"6020","name":"Overview of comments received on 'guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees'","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/324712/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-guideline-veterinary-medicinal-products-controlling-varroa-destructor-parasitosis-bees_en.pdf"},
    {"id":"6021","name":"EU/3/15/1466: Public summary of positive opinion for orphan designation of ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL7A1-encoding retroviral vector for the treat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/116155/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151466-public-summary-positive-opinion-orphan-designation-ex-vivo-expanded-autologous-human-keratinocytes-containing-epidermal-stem-cells-transduced-col7a1-encoding-retroviral-vector-treat_en.pdf"},
    {"id":"6023","name":"Agenda - Annual workshop of the European network of paediatric research at the European Medicines Agency","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-04-08T17:00:00Z","last_updated_date":"2015-06-18T16:00:00Z","reference_number":"EMA/150699/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-annual-workshop-european-network-paediatric-research-european-medicines-agency_en.pdf"},
    {"id":"6024","name":"Presentation - Session 2: Overview of the OMOP common data model (Peter Rijnbeek)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-overview-omop-common-data-model-peter-rijnbeek_en.pdf"},
    {"id":"6025","name":"Final list of references supporting the assessment of Juniperus communis L., aetheroleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMA/HMPC/12399/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-juniperus-communis-l-aetheroleum_en.pdf"},
    {"id":"6026","name":"Presentation - Session V - Long-term outcomes","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-18T02:00:00Z","last_updated_date":"2016-10-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-v-long-term-outcomes_en.pdf"},
    {"id":"6028","name":"Opinion following an Article 31 referral for Calcitonins containing medicinal products International Non-Proprietary Name (INN): Calcitonin: Background information and Annexes I,II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-02-28T00:08:21Z","last_updated_date":"2004-02-28T00:08:21Z","reference_number":"CPMP/867/04","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-calcitonins-containing-medicinal-products-international-non-proprietary-name-inn-calcitonin-background-information-and-annexes-iii_en.pdf"},
    {"id":"6030","name":"EU/3/17/1941: Public summary of opinion on orphan designation:\n\nDiazoxide choline for the treatment of Prader-Willi syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-12T01:00:00Z","last_updated_date":"2018-01-12T01:00:00Z","reference_number":"EMA/699103/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171941-public-summary-opinion-orphan-designation-diazoxide-choline-treatment-prader-willi-syndrome_en.pdf"},
    {"id":"6032","name":"Minutes of the drafting meeting on the framework for the interaction between the Agency and Healthcare Professionals' Organisations","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2010-09-22T02:00:00Z","last_updated_date":"2010-09-22T02:00:00Z","reference_number":"EMA/424967/2010","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-drafting-meeting-framework-interaction-between-agency-and-healthcare-professionals-organisations_en.pdf"},
    {"id":"6035","name":"Presentation - Clinical aspects for cell-based therapies for cardiac repair (Pieter A. Doevendans)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T02:00:00Z","last_updated_date":"2014-10-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-aspects-cell-based-therapies-cardiac-repair-pieter-doevendans_en.pdf"},
    {"id":"6037","name":"EU/3/12/1075 : Public summary of opinion on orphan designation: Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt for ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-24T13:15:00Z","last_updated_date":"2013-01-24T13:15:00Z","reference_number":"EMA/COMP/744439/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121075-public-summary-opinion-orphan-designation-cyclo-gamma-aminobutyryl-l-phenylalanyl-l-tryptophanyl-d-tryptophanyl-l-lysyl-l-threonyl-l-phenylalanyl-n-3-carboxypropyl-glycine-amide-acetate-salt_en.pdf"},
    {"id":"6038","name":"CHMP post-authorisation summary of positive opinion for Abilify on 24 April 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/156983/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abilify-24-april-2008_en.pdf"},
    {"id":"6039","name":"Scientific recommendation on classification of advanced therapy medicinal products: heterologous human adult liver-derived progenitor cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-10-21T20:00:00Z","last_updated_date":"2016-10-21T20:00:00Z","reference_number":"EMA/680696/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-heterologous-human-adult-liver-derived-progenitor-cells_en.pdf"},
    {"id":"6043","name":"Buflomedil - Article 107 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-13T02:00:00Z","last_updated_date":"2012-06-13T02:00:00Z","reference_number":"EMA/CHMP/83070/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/buflomedil-article-107-referral-assessment-report_en.pdf"},
    {"id":"6045","name":"Final assessment report on Carum carvi L.,fructus and Carum carvi L., aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/HMPC/715093/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-carum-carvi-lfructus-and-carum-carvi-l-aetheroleum_en.pdf"},
    {"id":"6046","name":"Primary Endpoints in 'Alzheimer's Dementia' - Karl Broich","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-11T00:09:21Z","last_updated_date":"2008-02-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/primary-endpoints-alzheimers-dementia-karl-broich_en.pdf"},
    {"id":"6048","name":"Fenofibrate: List of nationally authorised medicinal products - PSUSA/00001362/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T18:40:00Z","last_updated_date":"2018-04-18T18:40:27Z","reference_number":"EMA/243033/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fenofibrate-list-nationally-authorised-medicinal-products-psusa00001362201707_en.pdf"},
    {"id":"6052","name":"Practical_guidelines on the use of the eCTD format for Plasma Master File holders (PMF - H)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-08-01T02:00:00Z","last_updated_date":"2009-08-01T02:00:00Z","reference_number":"EMEA/512725/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical_guidelines-use-ectd-format-plasma-master-file-holders-pmf-h_en.pdf"},
    {"id":"6054","name":"CHMP summary of positive opinion for Docetaxel Kabi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-03-16T01:00:00Z","reference_number":"EMA/CHMP/56643/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-docetaxel-kabi_en.pdf"},
    {"id":"6057","name":"Saw palmetto fruit: summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T17:00:00Z","last_updated_date":"2016-04-28T17:00:00Z","reference_number":"EMA/823974/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/saw-palmetto-fruit-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/saw-palmetto-fruit-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/saw-palmetto-fruit-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/saw-palmetto-fruit-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/saw-palmetto-fruit-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/saw-palmetto-fruit-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/saw-palmetto-fruit-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/saw-palmetto-fruit-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/saw-palmetto-fruit-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/saw-palmetto-fruit-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/saw-palmetto-fruit-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/saw-palmetto-fruit-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/saw-palmetto-fruit-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/saw-palmetto-fruit-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/saw-palmetto-fruit-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/saw-palmetto-fruit-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/saw-palmetto-fruit-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/saw-palmetto-fruit-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/saw-palmetto-fruit-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/saw-palmetto-fruit-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/saw-palmetto-fruit-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/saw-palmetto-fruit-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/saw-palmetto-fruit-summary-public_sv.pdf"}},
    {"id":"6058","name":"EMEA/PEG Procedure for identifying paediatric needs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-06-29T02:00:00Z","last_updated_date":"2005-06-29T02:00:00Z","reference_number":"EMEA/175192/2004/rev2","document_url":"https://www.ema.europa.eu/en/documents/other/emeapeg-procedure-identifying-paediatric-needs_en.pdf"},
    {"id":"6061","name":"Overview of comments on 'Guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater' (EMA/CVMP/ERA/103555/2015)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-04-30T13:33:00Z","last_updated_date":"2018-04-30T13:33:00Z","reference_number":"EMA/CVMP/ERA/609438/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-guideline-assessing-toxicological-risk-human-health-and-groundwater-communities-veterinary-pharmaceuticals-groundwater-emacvmpera1035552015_en.pdf"},
    {"id":"6062","name":"Draft addendum to the note for guidance on evaluation of medicinal products Indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacte...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/14377/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-specifically-address-clinical-development-new-agents-treat-disease-due-mycobacte_en.pdf"},
    {"id":"6063","name":"Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2016-10-18T13:42:37Z","reference_number":"EMA/729829/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/furosemide-list-nationally-authorised-medicinal-products-psusa00001491201501_en.pdf"},
    {"id":"6067","name":"Scientific recommendation on classification of advanced therapy medicinal products: allogeneic (human Wharton’s jelly derived) mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T15:30:00Z","last_updated_date":"2016-04-19T15:30:00Z","reference_number":"EMA/240980/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-human-whartons-jelly-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"6068","name":"Rafoxanide: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/636/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/rafoxanide-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6071","name":"EU/3/16/1788: Public summary of positive opinion for orphan designation of sodium benzoate for the treatment of N-acetylglutamate synthase deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T15:43:00Z","last_updated_date":"2016-12-14T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161788-public-summary-positive-opinion-orphan-designation-sodium-benzoate-treatment-n-acetylglutamate-synthase-deficiency_en.pdf"},
    {"id":"6072","name":"Guidance on format of the risk-management plan in the European Union part II: Module SIII - Clinical-trial exposure","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2012-11-14T01:00:00Z","reference_number":"EMA/710081/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-siii-clinical-trial-exposure_en.doc"},
    {"id":"6073","name":"CHMP summary of positive opinion for Hemlibra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-01-26T13:00:00Z","reference_number":"EMA/CHMP/785115/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hemlibra_en.pdf"},
    {"id":"6074","name":"Updated application software","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-29T02:00:00Z","last_updated_date":"2010-03-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/updated-application-software_en.zip"},
    {"id":"6075","name":"GxP Inspections within the centralised procedure - Brendan Cuddy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/gxp-inspections-within-centralised-procedure-brendan-cuddy_en.pdf"},
    {"id":"6078","name":"Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-09-20T13:00:00Z","last_updated_date":"2017-09-20T13:00:00Z","reference_number":"CPMP/EWP/235/95 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-chronic-heart-failure-revision-2_en.pdf"},
    {"id":"6082","name":"Presentation - Drugs for multiple drug resistant (MDR) pathogens: Issues in development (Mark Goldberger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-drugs-multiple-drug-resistant-mdr-pathogens-issues-development-mark-goldberger_en.pdf"},
    {"id":"6084","name":"Presentation - Harnessing mobile apps and social media for product safety(Phil Tregunno)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/presentation-harnessing-mobile-apps-and-social-media-product-safetyphil-tregunno_en.pdf"},
    {"id":"6086","name":"CHMP summary of positive opinion for Symtuza","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T14:00:00Z","last_updated_date":"2017-07-21T14:00:00Z","reference_number":"EMA/411074/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-symtuza_en.pdf"},
    {"id":"6087","name":"European Medicines Agency workshop on viral safety of plasma-derived medicinal products with particular focus on non-enveloped viruses, 13 September 2000: Summary report","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2001-03-28T02:09:21Z","last_updated_date":"2001-03-28T02:09:21Z","reference_number":"CPMP/BWP/BPWG/4080/00","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-workshop-viral-safety-plasma-derived-medicinal-products-particular-focus-non-enveloped-viruses-13-september-2000-summary-report_en.pdf"},
    {"id":"6088","name":"Linco-Spectin 100 and associated names: Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-04T02:00:00Z","last_updated_date":"2014-09-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/linco-spectin-100-and-associated-names-annex-i-ii-iii_sv.pdf"}},
    {"id":"6090","name":"Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-06-05T11:15:00Z","last_updated_date":"2015-06-05T11:15:00Z","reference_number":"EMA/HMPC/95714/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-microbiological-aspects-herbal-medicinal-products-and-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"6094","name":"European Medicines Agency now publishing meeting agendas for all scientific committees","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T13:00:00Z","last_updated_date":"2013-12-17T13:00:00Z","reference_number":"EMA/788618/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-now-publishing-meeting-agendas-all-scientific-committees_en.pdf"},
    {"id":"6096","name":"Committee for medicinal products for human use, summary of positive opinion for Instanyl","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/65031/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-instanyl_en.pdf"},
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    {"id":"6099","name":"EMA’s first public hearing: giving EU citizens a voice to help reduce the risk of valproate","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"EMA/630591/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/emas-first-public-hearing-giving-eu-citizens-voice-help-reduce-risk-valproate_en.pdf"},
    {"id":"6103","name":"Opinion of the CVMP on the establishment of maximum residue limits: Sisapronil","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-12-11T11:17:00Z","last_updated_date":"2015-12-11T11:17:00Z","reference_number":"EMA/CVMP/259372/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-sisapronil_en.pdf"},
    {"id":"6104","name":"Testing for SV40 in poliovirus vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-04-25T02:00:00Z","last_updated_date":"2002-04-25T02:00:00Z","reference_number":"CPMP/BWP/1412/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/testing-sv40-poliovirus-vaccines_en.pdf"},
    {"id":"6107","name":"Monthly report - Pharmacovigilance Working Party (PhVWP) July 2011 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"EMA/CHMP/PhVWP/569591/2011","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-july-2011-plenary-meeting_en.pdf"},
    {"id":"6108","name":"Committee for medicinal products for human use, summary of positive opinion for  Velmetia","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-04-30T02:00:00Z","last_updated_date":"2008-04-30T02:00:00Z","reference_number":"EMEA/CHMP/216688/2008-corr","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-velmetia_en.pdf"},
    {"id":"6109","name":"Participants list - Fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T16:00:00Z","last_updated_date":"2015-06-25T16:00:00Z","reference_number":"EMA/402803/2015","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-fourth-industry-stakeholder-platform-operation-european-union-pharmacovigilance-legislation_en.pdf"},
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    {"id":"6113","name":"Zolpidem Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-12-06T16:45:00Z","reference_number":"EMA/PRAC/418739/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/zolpidem-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"6114","name":"Working groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-21T02:09:21Z","last_updated_date":"2009-04-21T02:09:21Z","reference_number":"EMEA/248833/200","document_url":"https://www.ema.europa.eu/en/documents/other/working-groups_en.pdf"},
    {"id":"6116","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting on 4 June 2015","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-05-27T13:00:00Z","last_updated_date":"2015-09-01T13:00:00Z","reference_number":"EMA/167496/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-4-june-2015_en.pdf"},
    {"id":"6117","name":"Draft assessment report on Plantaginis lanceolatae folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-01-26T01:00:00Z","last_updated_date":"2011-01-26T01:00:00Z","reference_number":"EMA/HMPC/437859/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-plantaginis-lanceolatae-folium_en.pdf"},
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    {"id":"6120","name":"32nd meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-05-07T14:09:21Z","last_updated_date":"1998-05-07T14:09:21Z","reference_number":"EMEA/CVMP/210/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/32nd-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6122","name":"Presentation - Workshop on data requirements for vaccines March 2015: industry reflections","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-data-requirements-vaccines-march-2015-industry-reflections_en.pdf"},
    {"id":"6125","name":"Takeda withdraws its marketing authorisation application for Ramelteon","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-25T02:09:21Z","last_updated_date":"2008-09-25T02:09:21Z","reference_number":"EMEA/504716/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/takeda-withdraws-its-marketing-authorisation-application-ramelteon_en.pdf"},
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    {"id":"6130","name":"EU/3/08/547: Public summary of positive opinion for orphan designation of anti-von Willebrand aptamer for the treatment of thrombotic thrombocytopenic purpura","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/205588/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308547-public-summary-positive-opinion-orphan-designation-anti-von-willebrand-aptamer-treatment-thrombotic-thrombocytopenic-purpura_en.pdf"},
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    {"id":"6134","name":"CHMP summary of positive opinion for Somac Control","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2009-02-18T01:00:00Z","reference_number":"EMEA/CHMP/108577/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-somac-control_en.pdf"},
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    {"id":"6146","name":"CHMP summary of opinion for Oncaspar","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"EMA/CHMP/734982/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-oncaspar_en.pdf"},
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    {"id":"6153","name":"Overview of comments received on draft guideline on criteria for requiring one additional five-year renewal for centrally authorised medicinal products (EMEA/131973/2006)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-29T01:00:00Z","last_updated_date":"2008-01-29T01:00:00Z","reference_number":"EMEA/29922/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-criteria-requiring-one-additional-five-year-renewal-centrally-authorised-medicinal-products-emea1319732006_en.pdf"},
    {"id":"6154","name":"Presentation - Good pharmacovigilance practices (GVP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-gvp_en.pdf"},
    {"id":"6155","name":"FDA and EMA Agree to Accept a Single Orphan Drug Designation Annual Report","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-02-26T01:00:00Z","last_updated_date":"2010-02-26T01:00:00Z","reference_number":"EMA/121846/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/fda-and-ema-agree-accept-single-orphan-drug-designation-annual-report_en.pdf"},
    {"id":"6157","name":"EU/3/13/1227: Public summary of opinion on orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, for the treatment of adenovirus infection in allogeneic haematopoieti...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/COMP/4626/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131227-public-summary-opinion-orphan-designation-adenovirus-specific-t-cells-derived-allogeneic-donor-leukocytes-expanded-ex-vivo-treatment-adenovirus-infection-allogeneic-haematopoieti_en.pdf"},
    {"id":"6159","name":"Presentation - User test","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-user-test_en.pdf"},
    {"id":"6160","name":"EU/3/09/674: Public summary of positive opinion for orphan designation of recombinant human serum amyloid P for the prevention of scarring post glaucoma filtration surgery","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2014-04-03T18:00:00Z","reference_number":"EMEA/COMP/478310/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309674-public-summary-positive-opinion-orphan-designation-recombinant-human-serum-amyloid-p-prevention-scarring-post-glaucoma-filtration-surgery_en.pdf"},
    {"id":"6161","name":"CHMP post-authorisation summary of positive opinion for Benlysta (X-46-G)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T14:00:00Z","last_updated_date":"2017-09-15T14:00:00Z","reference_number":"EMA/CHMP/601079/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-benlysta-x-46-g_en.pdf"},
    {"id":"6165","name":"Draft list of references for assessment of Urticae radix: Urtica dioica L., Urtica urens L. (nettle root) - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/461158/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-urticae-radix-urtica-dioica-l-urtica-urens-l-nettle-root-first-version_en.pdf"},
    {"id":"6166","name":"Artemether / lumefantrin (dispersible tablet): List of nationally authorised medicinal products - PSUSA/0009060/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2016-10-17T19:40:11Z","reference_number":"EMA/833224/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/artemether-lumefantrin-dispersible-tablet-list-nationally-authorised-medicinal-products-psusa0009060201504_en.pdf"},
    {"id":"6167","name":"Paroxetine: List of nationally authorised medicinal products -    PSUSA/00002319/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-11T17:45:00Z","last_updated_date":"2018-09-11T17:51:34Z","reference_number":"EMA/612747/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/paroxetine-list-nationally-authorised-medicinal-products-psusa00002319201712_en.pdf"},
    {"id":"6169","name":"Bromocriptine Article-31 referral - PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-09-06T02:00:00Z","last_updated_date":"2013-09-06T02:00:00Z","reference_number":"EMA/PRAC/493207/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"6170","name":"Assessment of the paediatric needs - Anti-infectious therapy with focus on antimycotics, antivirals (except HIV)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-10-01T02:00:00Z","last_updated_date":"2006-10-01T02:00:00Z","reference_number":"EMEA/435350/2006","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-anti-infectious-therapy-focus-antimycotics-antivirals-except-hiv_en.pdf"},
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    {"id":"6238","name":"Presentation - World Health Organization (WHO) - Efforts to reduce the impact on public and animal health of antibiotic use in animals (Danilo Lo Fo Wong)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-world-health-organization-who-efforts-reduce-impact-public-and-animal-health-antibiotic-use-animals-danilo-lo-fo-wong_en.pdf"},
    {"id":"6239","name":"Opinion of the CVMP on the establishment of maximum residue limits: Sodium Salicylate","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CVMP/13789/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-sodium-salicylate_en.pdf"},
    {"id":"6240","name":"Presentation - The immunotherapy of cancer: past, present and the next frontier (Ira Mellman) - S1.1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunotherapy-cancer-past-present-and-next-frontier-ira-mellman-s11_en.pdf"},
    {"id":"6241","name":"Questions and answers on the review of Piroxicam","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-06-21T02:08:21Z","last_updated_date":"2007-06-21T02:08:21Z","reference_number":"EMEA/264578/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-piroxicam_en.pdf"},
    {"id":"6242","name":"EU/3/18/2030: Public summary of opinion on orphan designation: 20-hydroxyecdysone for treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T18:21:00Z","last_updated_date":"2018-08-21T18:21:00Z","reference_number":"EMA/382043/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182030-public-summary-opinion-orphan-designation-20-hydroxyecdysone-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"6247","name":"ISTA Pharma Ltd withdraws its marketing authorisation application for Vitragan","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-04-30T02:09:21Z","last_updated_date":"2007-04-30T02:09:21Z","reference_number":"EMEA/193194/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/ista-pharma-ltd-withdraws-its-marketing-authorisation-application-vitragan_en.pdf"},
    {"id":"6251","name":"Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2010","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-02-05T01:00:00Z","last_updated_date":"2010-02-05T01:00:00Z","reference_number":"EMA/INS/GCP/782669/2009","document_url":"https://www.ema.europa.eu/en/documents/other/workplan-good-clinical-practice-inspectors-working-group-gcp-iwg-2010_en.pdf"},
    {"id":"6254","name":"EU/3/18/2031: Public summary of opinion on orphan designation: Argon for the treatment of perinatal asphyxia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-22T11:52:00Z","last_updated_date":"2018-08-22T11:52:00Z","reference_number":"EMA/395053/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182031-public-summary-opinion-orphan-designation-argon-treatment-perinatal-asphyxia_en.pdf"},
    {"id":"6257","name":"Withdrawal assessment report for Vekacia","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-02-26T01:00:00Z","last_updated_date":"2009-02-26T01:00:00Z","reference_number":"EMEA/CHMP/51709/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-vekacia_en.pdf"},
    {"id":"6260","name":"Tolperisone Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2013-04-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tolperisone-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tolperisone-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tolperisone-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tolperisone-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tolperisone-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tolperisone-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tolperisone-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tolperisone-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tolperisone-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tolperisone-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tolperisone-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tolperisone-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tolperisone-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tolperisone-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tolperisone-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tolperisone-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tolperisone-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tolperisone-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tolperisone-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tolperisone-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tolperisone-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tolperisone-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"6261","name":"Iclusig Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-06T13:00:00Z","last_updated_date":"2013-12-06T13:00:00Z","reference_number":"EMA/PRAC/746091/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"6262","name":"CHMP post-authorisation summary of positive opinion for Cymbalta on 22 October 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/CHMP/656849/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cymbalta-22-october-2009_en.pdf"},
    {"id":"6264","name":"Superseded assessment report on Rhamnus purshianus D.C. and Rhamni purshianae cortex - Cascara and herbal preparation(s) thereof with well-established use and traditional use","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-06-05T02:09:00Z","last_updated_date":"2008-06-05T02:09:00Z","reference_number":"EMEA/HMPC/513580/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-rhamnus-purshianus-dc-and-rhamni-purshianae-cortex-cascara-and-herbal-preparations-thereof-well-established-use-and-traditional-use_en.pdf"},
    {"id":"6265","name":"CVMP summary of positive opinion for Credelio","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-02-17T01:00:00Z","last_updated_date":"2017-02-17T01:00:00Z","reference_number":"EMA/CVMP/49053/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-credelio_en.pdf"},
    {"id":"6266","name":"Format for risk-management-plan submissions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-31T13:02:00Z","last_updated_date":"2013-01-31T13:02:00Z","reference_number":"EMA/793396/2012","document_url":"https://www.ema.europa.eu/en/documents/other/format-risk-management-plan-submissions_en.pdf"},
    {"id":"6268","name":"Guideline on clinical investigation of medicinal products in the treatment of hypertension","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/238/1995/Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-hypertension_en.pdf"},
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    {"id":"6271","name":"Presentation - Impact of future legislation on availability (Pablo Hervà¡s Calle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T02:00:00Z","last_updated_date":"2017-03-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-future-legislation-availability-pablo-hervas-calle_en.pdf"},
    {"id":"6272","name":"EU/3/11/895: Public summary of opinion on orphan designation: Hydroxy-propyl-beta-cyclodextrin for the treatment of Niemann-Pick disease, type C","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-09-21T02:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMA/COMP/546608/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311895-public-summary-opinion-orphan-designation-hydroxy-propyl-beta-cyclodextrin-treatment-niemann-pick-disease-type-c_en.pdf"},
    {"id":"6273","name":"CHMP post-authorisation summary of positive opinion for Busilvex","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2023-08-04T12:53:00Z","reference_number":"EMA/CHMP/450097/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-busilvex_en.pdf"},
    {"id":"6274","name":"Presentation - Phasing in Issues – Impact on Nationally authorised products MA status from traditional herbal to advanced therapy medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-phasing-issues-impact-nationally-authorised-products-ma-status-traditional-herbal-advanced-therapy-medicinal-products_en.pdf"},
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    {"id":"6278","name":"Report of the ENCePP Scientific Convention \"EU health care databases for pan-EU pharmacoepidemiological research\"","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-12-08T01:00:00Z","last_updated_date":"2008-12-08T01:00:00Z","reference_number":"EMEA/657414/2008","document_url":"https://www.ema.europa.eu/en/documents/report/report-encepp-scientific-convention-eu-health-care-databases-pan-eu-pharmacoepidemiological-research_en.pdf"},
    {"id":"6280","name":"CHMP summary of positive opinion for Mercaptopurine Nova Laboratories","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/CHMP/470877/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mercaptopurine-nova-laboratories_en.pdf"},
    {"id":"6281","name":"EU/3/16/1775: Public summary of positive opinion for orphan designation of alpha-tocopherol for the treatment of facioscapulohumeral muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T14:41:00Z","last_updated_date":"2016-12-14T14:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161775-public-summary-positive-opinion-orphan-designation-alpha-tocopherol-treatment-facioscapulohumeral-muscular-dystrophy_en.pdf"},
    {"id":"6282","name":"Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-06-23T02:00:00Z","last_updated_date":"2005-06-23T02:00:00Z","reference_number":"CPMP/EWP/438/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-psoriatic-arthritis_en.pdf"},
    {"id":"6284","name":"Withdrawal assessment report for Taxotere","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"EMEA/632212/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-taxotere_en.pdf"},
    {"id":"6285","name":"Agenda - CAT agenda of the 15-16 April 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-04-16T18:30:00Z","last_updated_date":"2014-04-16T18:30:00Z","reference_number":"EMA/CAT/231892/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-16-april-2014-meeting_en.pdf"},
    {"id":"6287","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 16-19 November 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-11-27T12:30:00Z","last_updated_date":"2015-11-27T12:30:00Z","reference_number":"EMA/38688/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-during-chmp-meeting-16-19-november-2015_en.pdf"},
    {"id":"6288","name":"Tiaprost: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-02-01T00:09:21Z","last_updated_date":"1999-02-01T00:09:21Z","reference_number":"EMEA/MRL/502/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tiaprost-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6289","name":"Presentation - Encouraging joint PASS submissions (I. Rager)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T15:08:00Z","last_updated_date":"2018-01-04T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-encouraging-joint-pass-submissions-i-rager_en.pdf"},
    {"id":"6293","name":"EU/3/16/1659: Public summary of opinion on orphan designation: Arimoclomol citrate for the treatment of inclusion body myositis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2022-07-19T11:28:00Z","reference_number":"EMA/COMP/306904/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161659-public-summary-opinion-orphan-designation-arimoclomol-citrate-treatment-inclusion-body-myositis_en.pdf"},
    {"id":"6294","name":"Thiamphenicol (extension to pigs): Summary Report (5) – Committee for Medicinal Products for Veterinary use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-01-01T00:09:21Z","last_updated_date":"2005-01-01T00:09:21Z","reference_number":"EMEA/CVMP/2316/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/thiamphenicol-extension-pigs-summary-report-5-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"6295","name":"CHMP summary of positive opinion for Ritonavir Mylan","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T14:00:00Z","last_updated_date":"2017-09-15T14:00:00Z","reference_number":"EMA/CHMP/541227/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ritonavir-mylan_en.pdf"},
    {"id":"6297","name":"Questions and answers relating to open tender procedure EMA/2013/06/PD – Document delivery services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-22T12:22:00Z","last_updated_date":"2013-11-20T16:30:00Z","reference_number":"EMA/645559/2013","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-open-tender-procedure-ema201306pd-document-delivery-services_en.pdf"},
    {"id":"6299","name":"Superseded European Union herbal monograph on Hedera helix L., folium - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-01-18T01:00:00Z","last_updated_date":"2018-08-13T02:00:00Z","reference_number":"EMA/HMPC/586888/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-european-union-herbal-monograph-hedera-helix-l-folium-revision-1_en.pdf"},
    {"id":"6305","name":"Annual report of the European Medicines Agency 2008","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2009-07-03T02:00:00Z","last_updated_date":"2009-07-03T02:00:00Z","reference_number":"EMEA/330566/2009","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2008_en.pdf"},
    {"id":"6306","name":"Nadroparin: List of nationally authorised medicinal products - PSUSA/00002104/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-10T01:00:00Z","last_updated_date":"2016-10-18T12:21:21Z","reference_number":"EMA/838082/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/nadroparin-list-nationally-authorised-medicinal-products-psusa00002104201503_en.pdf"},
    {"id":"6308","name":"Paracetamol Article-31 referral - PRAC assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-01T01:00:00Z","last_updated_date":"2018-03-01T01:00:00Z","reference_number":"EMA/94286/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"6310","name":"CHMP summary of positive opinion for Zyclara","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/423167/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zyclara_en.pdf"},
    {"id":"6311","name":"Guideline on reporting the results of population pharmacokinetic analyses","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-06-21T02:00:00Z","last_updated_date":"2007-06-21T02:00:00Z","reference_number":"CHMP/EWP/185990/06","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-results-population-pharmacokinetic-analyses_en.pdf"},
    {"id":"6312","name":"Presentation - Making best use of the PSUR Repository (Jean Louis Hottart)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-making-best-use-psur-repository-jean-louis-hottart_en.pdf"},
    {"id":"6314","name":"EU/3/10/827: Public summary of opinion on orphan designation: Recombinant human lysosomal acid lipase for the treatment of lysosomal acid lipase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2015-03-24T13:00:00Z","reference_number":"EMA/COMP/662892/2010 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310827-public-summary-opinion-orphan-designation-recombinant-human-lysosomal-acid-lipase-treatment-lysosomal-acid-lipase-deficiency_en.pdf"},
    {"id":"6315","name":"Final European Union herbal monograph on Echinacea purpurea (L.) Moench., herba recens","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-04-13T02:00:00Z","last_updated_date":"2015-12-11T14:30:00Z","reference_number":"EMA/HMPC/48704/2014 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"6316","name":"Flupirtine-containing medicines Article-107i procedure - PRAC list of questions to be addressed by the stakeholders","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-08T13:00:00Z","last_updated_date":"2013-03-08T13:00:00Z","reference_number":"EMA/PRAC/144072/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-prac-list-questions-be-addressed-stakeholders_en.pdf"},
    {"id":"6317","name":"EU/3/05/281: Public summary of positive opinion of interferon gamma for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2007-05-30T02:00:00Z","reference_number":"EMEA/COMP/130719/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305281-public-summary-positive-opinion-interferon-gamma-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"6320","name":"EU/3/09/701: Public summary of opinion on orphan designation of 2-iminobiotin for the treatment of perinatal asphyxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMA/COMP/761401/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309701-public-summary-opinion-orphan-designation-2-iminobiotin-treatment-perinatal-asphyxia_en.pdf"},
    {"id":"6322","name":"Report of EMEA expert meeting on the revision of the core SPC and note for guidance for human normal immunoglobulin for intravenous administration (IVIg)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2008-01-24T00:09:21Z","last_updated_date":"2008-01-24T00:09:21Z","reference_number":"EMEA/CHMP/BPWP/361857/2006","document_url":"https://www.ema.europa.eu/en/documents/report/report-emea-expert-meeting-revision-core-spc-and-note-guidance-human-normal-immunoglobulin-intravenous-administration-ivig_en.pdf"},
    {"id":"6329","name":"Presentation - Drug shortages project of law in France (Dominique Debourges)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-drug-shortages-project-law-france-dominique-debourges_en.pdf"},
    {"id":"6331","name":"Guidance on triggers for inspections of bioequivalence trials: quick scan","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-08-20T11:30:00Z","last_updated_date":"2017-03-02T10:40:00Z","reference_number":"EMA/745861/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-triggers-inspections-bioequivalence-trials-quick-scan_en.pdf"},
    {"id":"6334","name":"EU/3/16/1760: Public summary of positive opinion for orphan designation of radio-iodinated (131I) anti-CD45 murine monoclonal antibody for treatment in haematopoietic stem cell transplantation","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161760-public-summary-positive-opinion-orphan-designation-radio-iodinated-131i-anti-cd45-murine-monoclonal-antibody-treatment-haematopoietic-stem-cell-transplantation_en.pdf"},
    {"id":"6335","name":"Overview of comments received on draft guideline on follow-up of patients administered with gene therapy medicinal products (EMEA/CHMP/GTWP/60436/2007)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-11-13T00:09:21Z","last_updated_date":"2009-11-13T00:09:21Z","reference_number":"EMEA/570240/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-follow-patients-administered-gene-therapy-medicinal-products-emeachmpgtwp604362007_en.pdf"},
    {"id":"6337","name":"EMA communication perception survey report 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-07-18T13:40:00Z","last_updated_date":"2018-07-18T13:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/ema-communication-perception-survey-report-2017_en.pdf"},
    {"id":"6339","name":"European Veterinary Pharmacovigilance reporting form for MAHs","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/european-veterinary-pharmacovigilance-reporting-form-mahs_en.doc"},
    {"id":"6342","name":"Soya-bean oil: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-05-11T02:00:00Z","last_updated_date":"2017-05-11T02:00:00Z","reference_number":"EMA/93396/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/soya-bean-oil-summary-public_en.pdf"},
    {"id":"6345","name":"Overview of comments received on the draft guideline on Allergen products: Production and quality issues","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"EMEA/CHMP/BWP/596200/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-allergen-products-production-and-quality-issues_en.pdf"},
    {"id":"6349","name":"Presentation - EU funded research projects and the link with authorisation of new antimicrobials (Arjon van Hengel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-funded-research-projects-and-link-authorisation-new-antimicrobials-arjon-van-hengel_en.pdf"},
    {"id":"6350","name":"European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/413801/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-advises-doctors-treating-patients-nosocomial-pneumonia-doribax_en.pdf"},
    {"id":"6352","name":"Amitriptyline: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation  - PSUSA/00000168/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-01T01:00:00Z","last_updated_date":"2016-10-17T19:40:12Z","reference_number":"EMA/792231/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000168201501_en.pdf"},
    {"id":"6353","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Gentiana Lutea L., radix  - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-03-05T01:00:00Z","last_updated_date":"2019-04-30T01:00:00Z","reference_number":"EMA/HMPC/678928/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-gentiana-lutea-l-radix-first-version_en.pdf"},
    {"id":"6354","name":"EU/3/13/1122: Public summary of opinion on orphan designation: R,S-O-(3-piperidino-2-hydroxy-1-propyl)-nicotinic acid amidoxime dihydrochloride for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-05-14T12:00:00Z","last_updated_date":"2015-03-24T11:00:00Z","reference_number":"EMA/COMP/185530/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131122-public-summary-opinion-orphan-designation-rs-o-3-piperidino-2-hydroxy-1-propyl-nicotinic-acid-amidoxime-dihydrochloride-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"6355","name":"Joint audit programme for EEA GMP inspectorates: Procedure for observing inspections","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T01:00:00Z","last_updated_date":"2019-02-22T11:06:00Z","reference_number":"EMA/617616/2015 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-eea-gmp-inspectorates-procedure-observing-inspections_en.pdf"},
    {"id":"6356","name":"CHMP post-authorisation summary of positive opinion for Yervoy (II-55)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-04-27T14:00:00Z","last_updated_date":"2018-04-27T14:00:00Z","reference_number":"EMA/CHMP/201590/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yervoy-ii-55_en.pdf"},
    {"id":"6357","name":"Presentation - Day 1: Visual function endpoints the regulatory perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-1-visual-function-endpoints-regulatory-perspective_en.pdf"},
    {"id":"6358","name":"Presentation - European Medicines Agency questions and answers on risk management plan (RMP) updates for centrally authorised medicinal products (Iordanis Gravanis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T16:15:00Z","last_updated_date":"2016-08-15T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-questions-and-answers-risk-management-plan-rmp-updates-centrally-authorised-medicinal-products-iordanis-gravanis_en.pdf"},
    {"id":"6359","name":"EU/3/10/783: Public summary of opinion on orphan designation: Recombinant fusion protein consisting of human coagulation factor VIII attached to the Fc domain of human IgG1 for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"EMA/COMP/367483/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310783-public-summary-opinion-orphan-designation-recombinant-fusion-protein-consisting-human-coagulation-factor-viii-attached-fc-domain-human-igg1-treatment-haemophilia_en.pdf"},
    {"id":"6360","name":"Final list of references supporting the assessment report on: Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-04-29T14:45:00Z","last_updated_date":"2014-04-29T14:45:00Z","reference_number":"EMA/HPC/7702/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-report-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"6361","name":"EMEA welcomes new members and observers to its Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-20T02:00:00Z","last_updated_date":"2008-06-20T02:00:00Z","reference_number":"EMEA/319013/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-welcomes-new-members-and-observers-its-management-board_en.pdf"},
    {"id":"6364","name":"Zydelig Article-20 procedure - EMA recommends new safety measures for Zydelig","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"EMA/201814/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zydelig-article-20-procedure-ema-recommends-new-safety-measures-zydelig_sv.pdf"}},
    {"id":"6367","name":"Programme and registration form - European Medicines Agency (EMA) / Drug Information Association (DIA) signal management information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-02-23T17:00:00Z","last_updated_date":"2017-09-25T11:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-and-registration-form-european-medicines-agency-ema-drug-information-association-dia-signal-management-information-day_en.pdf"},
    {"id":"6368","name":"Points to consider for an EMEA communications policy","type":"other","status":"Adopted","consultation_date":"","first_published_date":"1998-05-15T02:00:00Z","last_updated_date":"1998-05-15T02:00:00Z","reference_number":"EMEA/MB/011/98 - Rev.2","document_url":"https://www.ema.europa.eu/en/documents/other/points-consider-emea-communications-policy_en.pdf"},
    {"id":"6369","name":"Presentation - Viral subtypes and the development of the disease: what is the evidence, Igor Koralnik","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-viral-subtypes-and-development-disease-what-evidence-igor-koralnik_en.pdf"},
    {"id":"6372","name":"Seroquel, Seroquel XR and associated names Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-09T02:00:00Z","last_updated_date":"2014-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"6373","name":"Overview of comments received on 'Reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPv...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-05-23T11:00:00Z","last_updated_date":"2017-05-23T11:00:00Z","reference_number":"EMA/CVMP/401418/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-authorisation-veterinary-medicinal-products-containing-potential-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpv_en.pdf"},
    {"id":"6375","name":"Summary information on referral opinion pursuant to Article 6(13) of Commisssion Regulation (EC) No 1084/2003 for Viani Diskus and associated names (See Annex I) International Non-Proprietary Name (INN): salmeterol / 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    {"id":"6379","name":"CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-07-24T02:00:00Z","last_updated_date":"2014-07-24T02:00:00Z","reference_number":"EMA/444346/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_sv.pdf"}},
    {"id":"6380","name":"EU/3/04/233: Public summary of positive opinion for orphan designation of adeno-associated viral vector containing the human gamma sarcoglycan gene for the treatment of gamma sarcoglycanopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-11T02:00:00Z","last_updated_date":"2014-06-18T02:00:00Z","reference_number":"EMEA/COMP/336675/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304233-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-gamma-sarcoglycan-gene-treatment-gamma-sarcoglycanopathy_en.pdf"},
    {"id":"6382","name":"EU/3/10/790: Public summary of opinion on orphan designation: Ambrisentan for the treatment idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2011-09-05T02:00:00Z","reference_number":"EMA/COMP/450736/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310790-public-summary-opinion-orphan-designation-ambrisentan-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"6383","name":"Presentation - EudraVigilance: New developments and access to EudraVigilance data","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:10Z","last_updated_date":"2011-06-24T22:06:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-new-developments-and-access-eudravigilance-data_en.pdf"},
    {"id":"6384","name":"2016 activity report of the modelling and simulation working group (MSWG)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T10:00:00Z","last_updated_date":"2017-03-09T10:00:00Z","reference_number":"EMA/800956/2016","document_url":"https://www.ema.europa.eu/en/documents/report/2016-activity-report-modelling-and-simulation-working-group-mswg_en.pdf"},
    {"id":"6385","name":"COMP meeting report on the review of applications for orphan designation: November 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T15:50:00Z","last_updated_date":"2014-11-21T15:50:00Z","reference_number":"EMA/COMP/641491/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-november-2014_en.pdf"},
    {"id":"6386","name":"Minoxidil (topical formulation): CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002067/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-05T02:00:00Z","last_updated_date":"2016-10-18T12:21:20Z","reference_number":"EMA/587066/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/minoxidil-topical-formulation-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002067201510_en.pdf"},
    {"id":"6390","name":"Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation' - Revision 2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-09T18:30:00Z","last_updated_date":"2014-08-20T16:10:00Z","reference_number":"EMA/CHMP/CVMP/QWP/774027/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-stability-testing-applications-variations-marketing-authorisation-revision-2_en.pdf"},
    {"id":"6391","name":"Flumequine (Extension to bovine milk and turkey): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/MRL/707/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flumequine-extension-bovine-milk-and-turkey-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6394","name":"Tetrabenazine:List of nationally authorised medicinal products-PSUSA/00002911/201410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T12:30:00Z","last_updated_date":"2016-10-19T12:44:33Z","reference_number":"EMA/543826/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/tetrabenazinelist-nationally-authorised-medicinal-products-psusa00002911201410_en.pdf"},
    {"id":"6395","name":"CHMP summary of positive opinion for  Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T14:00:00Z","last_updated_date":"2017-05-19T14:00:00Z","reference_number":"EMA/CHMP/308697/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-efavirenzemtricitabinetenofovir-disoproxil-zentiva_en.pdf"},
    {"id":"6396","name":"European Medicines Agency update on stolen vials of Herceptin","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-17T02:00:00Z","last_updated_date":"2014-08-11T16:00:00Z","reference_number":"EMA/239072/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-update-stolen-vials-herceptin_en.pdf"},
    {"id":"6397","name":"Peracetic acid: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-02-01T01:00:00Z","last_updated_date":"1996-02-01T01:00:00Z","reference_number":"EMEA/MRL/060/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/peracetic-acid-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6400","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T11:26:00Z","last_updated_date":"2017-02-10T11:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-january-2017_en.pdf"},
    {"id":"6401","name":"CHMP post-authorisation summary of positive opinion for Rebif","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T11:21:00Z","last_updated_date":"2011-11-18T11:21:00Z","reference_number":"EMA/900110/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rebif_en.pdf"},
    {"id":"6402","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 16-17 December 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-12-18T00:09:21Z","last_updated_date":"2003-12-18T00:09:21Z","reference_number":"EMEA/CPMP/6199/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-16-17-december-2003_en.pdf"},
    {"id":"6406","name":"Final assessment report on Cucurbita pepo L., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/136022/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"6407","name":"Committee for Proprietary Medicinal Products (CPMP) 56th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-01-24T01:00:00Z","last_updated_date":"2000-01-24T01:00:00Z","reference_number":"CPMP/122/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-56th-plenary-meeting_en.pdf"},
    {"id":"6409","name":"Final  assessment report on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/HMPC/712648/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-myroxylon-balsamum-l-harms-var-pereirae-royle-harms-balsamum_en.pdf"},
    {"id":"6410","name":"EU/3/05/300: Public summary of positive opinion for orphan designation of nemorubicin hydrochloride for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-27T02:00:00Z","last_updated_date":"2005-10-27T02:00:00Z","reference_number":"EMEA/COMP/202152/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305300-public-summary-positive-opinion-orphan-designation-nemorubicin-hydrochloride-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"6415","name":"Presentation - OIE initiative establishing a global database on consumption of antimicrobials for animals: state of play (Barbara Freischem, Franà§ois Diaz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T13:00:00Z","last_updated_date":"2015-04-20T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-oie-initiative-establishing-global-database-consumption-antimicrobials-animals-state-play-barbara-freischem-franassois-diaz_en.pdf"},
    {"id":"6416","name":"Questions and answers on the review of Protelos and Osseor (strontium ranelate)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T11:00:00Z","last_updated_date":"2012-03-16T11:00:00Z","reference_number":"EMA/183047/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-protelos-and-osseor-strontium-ranelate_en.pdf"},
    {"id":"6418","name":"EU/3/06/389: Public summary of positive opinion for orphan designation of lestaurtinib for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T00:00:00Z","last_updated_date":"2015-05-08T19:00:00Z","reference_number":"EMEA/COMP/279986/2006 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306389-public-summary-positive-opinion-orphan-designation-lestaurtinib-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"6421","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 20-23 April 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-04-29T17:10:00Z","last_updated_date":"2015-04-29T17:10:00Z","reference_number":"EMA/28002/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-20-23-april-2015_en.pdf"},
    {"id":"6424","name":"EU/3/05/340: Public summary of positive opinion for imatinib mesilate for the treatment of myelodysplastic / myeloproliferative diseases","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/COMP/386759/2005 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305340-public-summary-positive-opinion-imatinib-mesilate-treatment-myelodysplastic-myeloproliferative-diseases_en.pdf"},
    {"id":"6428","name":"Presentation - Pharmacovigilance and signal management: experience and trend for future (Peter Ekstrà¶m)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-and-signal-management-experience-and-trend-future-peter-ekstrapm_en.pdf"},
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    {"id":"6440","name":"European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-12-09T17:00:00Z","last_updated_date":"2011-12-09T17:00:00Z","reference_number":"EMA/CHMP/954737/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-further-interim-recommendations-dealing-shortcomings-quality-assurance-ben-venue-laboratories_en.pdf"},
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    {"id":"6443","name":"Ergot derivatives Article-31 referral - Dihydroergotoxine - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-i_sv.pdf"}},
    {"id":"6444","name":"Submission of comments on the EMEA Transparency Policy draft for Public Consultation","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-06-17T02:09:21Z","last_updated_date":"2009-06-17T02:09:21Z","reference_number":"EMEA/380503/2009","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-emea-transparency-policy-draft-public-consultation_en.doc"},
    {"id":"6447","name":"Pharmacovigilance Risk Assessment Committee: one year of public health promotion and protection","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-07-19T19:00:00Z","last_updated_date":"2013-07-19T19:00:00Z","reference_number":"EMA/445949/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/pharmacovigilance-risk-assessment-committee-one-year-public-health-promotion-and-protection_en.pdf"},
    {"id":"6448","name":"Concept paper on the preparation of a guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-01-26T01:00:00Z","last_updated_date":"2006-01-26T01:00:00Z","reference_number":"EMEA/CHMP/EWP/18504/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-preparation-guideline-clinical-development-products-specific-immunotherapy-treatment-allergic-diseases_en.pdf"},
    {"id":"6450","name":"CHMP post-authorisation summary of positive opinion for Tarceva","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tarceva_en.pdf"},
    {"id":"6452","name":"EU/3/15/1457: Public summary of positive opinion for orphan designation of [5-(5-chloro-1H-pyrrolo[2,3-b]pyridin-3-ylmethyl)-pyridin-2-yl]-(6-trifluoromethyl-pyridin-3-ylmethyl)-amine hydrochloride for the treatment of t...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2022-02-02T02:00:00Z","reference_number":"EMA/COMP/125607/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151457-public-summary-positive-opinion-orphan-designation-5-5-chloro-1h-pyrrolo23-bpyridin-3-ylmethyl-pyridin-2-yl-6-trifluoromethyl-pyridin-3-ylmethyl-amine-hydrochloride-treatment-t_en.pdf"},
    {"id":"6455","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17–19 July 2018","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-07-20T16:30:00Z","last_updated_date":"2018-07-20T16:30:00Z","reference_number":"EMA/CVMP/475701/2018 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-july-2018_en.pdf"},
    {"id":"6456","name":"Presentation - Pharmacokinetic-pharmacodynamic assessment of topiramate dosing regimens for children with epilepsy 2 to less than 10 years of age - Break-out session 3 theme 4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacokinetic-pharmacodynamic-assessment-topiramate-dosing-regimens-children-epilepsy-2-less-10-years-age-break-out-session-3-theme-4_en.pdf"},
    {"id":"6458","name":"CHMP post-authorisation summary of positive opinion for Avastin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/CHMP/190702/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-avastin_en.pdf"},
    {"id":"6459","name":"Questions and answers on Seasonique and associated names (levonorgestrel / ethinylestradiol)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"EMA/383921/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-seasonique-and-associated-names-levonorgestrel-ethinylestradiol_sv.pdf"}},
    {"id":"6460","name":"EU/3/08/569: Public summary of positive opinion for orphan designation of pegylated L-asparaginase for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2013-03-13T01:00:00Z","reference_number":"EMEA/COMP/456792/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308569-public-summary-positive-opinion-orphan-designation-pegylated-l-asparaginase-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"6461","name":"ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - Step 5 - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/CHMP/ICH/320985/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-s3a-note-guidance-toxicokinetics-assessment-systemic-exposure-toxicity-studies-questions-and-answers-step-5-first-version_en.pdf"},
    {"id":"6464","name":"CHMP post-authorisation summary of positive opinion for Nimenrix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/512584/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-nimenrix_en.pdf"},
    {"id":"6465","name":"Substances related to nicotinic acid Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-13T18:00:00Z","last_updated_date":"2014-03-13T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-i_sv.pdf"}},
    {"id":"6467","name":"Presentation - Discussion of case study 3: a phase-3 study with two doses and secondary endpoints (Franz Konig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-discussion-case-study-3-phase-3-study-two-doses-and-secondary-endpoints-franz-konig_en.pdf"},
    {"id":"6468","name":"Fibrates (bezafibrate, ciprofibrate, fenofibrate and gemfibrozil) - Article-31 referral - changes to product information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fibrates-bezafibrate-ciprofibrate-fenofibrate-and-gemfibrozil-article-31-referral-changes-product-information_en.pdf"},
    {"id":"6473","name":"Questions and answers on Tavanic (levofloxacin; 250 and 500 mg film-coated tablets and 5mg/ml solution for infusion)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T15:00:00Z","last_updated_date":"2012-09-12T15:00:00Z","reference_number":"EMA/332109/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-tavanic-levofloxacin-250-and-500-mg-film-coated-tablets-and-5mgml-solution-infusion_sv.pdf"}},
    {"id":"6476","name":"Note for guidance on the establishment of maximum residue limits for Salmonidae and other fin fish","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-01-01T01:00:00Z","last_updated_date":"1998-01-01T01:00:00Z","reference_number":"EMEA/CVMP/153b/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-establishment-maximum-residue-limits-salmonidae-and-other-fin-fish_en.pdf"},
    {"id":"6478","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-09-14T18:15:00Z","last_updated_date":"2012-09-14T18:15:00Z","reference_number":"EMA/CVMP/576111/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-september-2012_en.pdf"},
    {"id":"6479","name":"Work Instructions for design of an analysis of EudraVigilance data","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T02:00:00Z","last_updated_date":"2019-01-07T09:30:00Z","reference_number":"WIN/H/3290","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-design-analysis-eudravigilance-data_en.pdf"},
    {"id":"6480","name":"Questions and answers on Ikorel, Dancor and associated names (nicorandil, 10 and 20 mg tablets)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-03-27T14:00:00Z","last_updated_date":"2015-06-30T15:00:00Z","reference_number":"EMA/199003/2015 ","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-ikorel-dancor-and-associated-names-nicorandil-10-and-20-mg-tablets_sv.pdf"}},
    {"id":"6482","name":"Concept paper on the need for requiring data to demonstrate the influence of maternally derived antibodies on the vaccination of very young animals","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-04-23T02:00:00Z","last_updated_date":"2007-04-23T02:00:00Z","reference_number":"EMEA/CVMP/IWP/501304/2006-CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-requiring-data-demonstrate-influence-maternally-derived-antibodies-vaccination-very-young-animals_en.pdf"},
    {"id":"6483","name":"LifeGlobal Media: Consultation procedure Public Assessment Report (CPAR)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-30T11:30:00Z","last_updated_date":"2017-10-30T11:30:00Z","reference_number":"EMA/CHMP/878394/2016","document_url":"https://www.ema.europa.eu/en/documents/other/lifeglobal-media-consultation-procedure-public-assessment-report-cpar_en.pdf"},
    {"id":"6484","name":"Presentation - Electronic submission of medicinal product information by marketing authorisation holders – Regulation (EC) No 726/2004, Article 57(2), 2nd subparagraph","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:13Z","last_updated_date":"2011-06-24T22:06:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronic-submission-medicinal-product-information-marketing-authorisation-holders-regulation-ec-no-7262004-article-572-2nd-subparagraph_en.pdf"},
    {"id":"6485","name":"CHMP summary of positive opinion for Hemangiol","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/CHMP/95120/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hemangiol_en.pdf"},
    {"id":"6489","name":"Overview of comments received on reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T16:00:00Z","last_updated_date":"2011-11-29T16:00:00Z","reference_number":"EMA/CVMP/SAGAM/358728/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-use-macrolides-lincosamides-and-streptogramins-mls-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal_en.pdf"},
    {"id":"6490","name":"Presentation - Healthcare Innovation Hub: Societal implications of personalised medicine - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthcare-innovation-hub-societal-implications-personalised-medicine-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop_en.pdf"},
    {"id":"6491","name":"Poulvac Bursa Plus - Article 33 (4) referral - Annexes I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-10-07T02:00:00Z","last_updated_date":"2010-10-07T02:00:00Z","reference_number":"EMA/698942/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/poulvac-bursa-plus-article-33-4-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"6492","name":"Overview of comments received on Public statement on Sambucus nigra L., fructus","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T02:00:00Z","last_updated_date":"2014-04-29T02:00:00Z","reference_number":"EMA/HMPC/551899/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-public-statement-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"6493","name":"European Medicines Agency prepares for approval of pandemic vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-04-30T02:00:00Z","last_updated_date":"2009-04-30T02:00:00Z","reference_number":"EMEA/271000/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-prepares-approval-pandemic-vaccines_en.pdf"},
    {"id":"6496","name":"Request for confirmation of the applicability of the Agency’s decision on class waivers","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-03-03T01:09:21Z","last_updated_date":"2010-03-03T01:09:21Z","reference_number":"EMA/72240/2008","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-confirmation-applicability-agencys-decision-class-waivers_en.pdf"},
    {"id":"6497","name":"Opinions on safety variations /  periodic safety update reports adopted at the CHMP meeting of 16-19 September 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-26T17:35:00Z","last_updated_date":"2013-09-26T17:35:00Z","reference_number":"EMA/568773/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-periodic-safety-update-reports-adopted-chmp-meeting-16-19-september-2013_en.pdf"},
    {"id":"6498","name":"Outcome of the public consultation on the EU Medicines Agencies Network Strategy to 2020","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/667824/2015","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-public-consultation-eu-medicines-agencies-network-strategy-2020_en.pdf"},
    {"id":"6499","name":"Superseded community herbal monograph on Pimpinella anisum L., aetheroleum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2014-06-18T02:09:21Z","reference_number":"EMEA/HMPC/263273/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-pimpinella-anisum-l-aetheroleum_en.pdf"},
    {"id":"6500","name":"CHMP post-authorisation summary of positive opinion for RotaTeq","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/CHMP/49745/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rotateq_en.pdf"},
    {"id":"6502","name":"EMEA public statement on Refludan (Lepirudin) - Fatal anaphylactic reactions","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-10-29T01:00:00Z","last_updated_date":"2002-10-29T01:00:00Z","reference_number":"EMEA/H/27717/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-refludan-lepirudin-fatal-anaphylactic-reactions_en.pdf"},
    {"id":"6503","name":"Almitrine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T02:00:00Z","last_updated_date":"2013-06-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-referral-annex-i_en.pdf"},
    {"id":"6504","name":"Letter of support to explore MRI methodology to be used to stratify populations of people with autism spectrum disorder (ASD)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T12:00:00Z","last_updated_date":"2015-12-09T12:00:00Z","reference_number":"EMA/794542/2015","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-explore-mri-methodology-be-used-stratify-populations-people-autism-spectrum-disorder-asd_en.pdf"},
    {"id":"6505","name":"Guideline on the limits of genotoxic impurities","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-28T02:00:00Z","last_updated_date":"2006-06-28T02:00:00Z","reference_number":"EMEA/CHMP/QWP/251344/2006 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-limits-genotoxic-impurities_en.pdf"},
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    {"id":"6507","name":"Pathogen specific database: Q fever","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-q-fever_en.pdf"},
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    {"id":"6560","name":"EU/3/16/1730 : Public summary of opinion on orphan designation: Sodium benzoate for the treatment of ornithine translocase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161730-public-summary-opinion-orphan-designation-sodium-benzoate-treatment-ornithine-translocase-deficiency_en.pdf"},
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    {"id":"6564","name":"CHMP post-authorisation summary of positive opinion for Herceptin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/822467/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-herceptin_en.pdf"},
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    {"id":"6567","name":"Dermatophagoides pteronyssinus / dermatophagoides farina (oromucosal use, products authorised via mutually recognition procedure and decentralised procedure)","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T11:26:00Z","last_updated_date":"2018-05-23T11:34:00Z","reference_number":"EMA/278412/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/dermatophagoides-pteronyssinus-dermatophagoides-farina-oromucosal-use-products-authorised-mutually-recognition-procedure-and-decentralised-procedure_en.pdf"},
    {"id":"6568","name":"Public statement on Irbesartan BMS (irbesartan) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-11-23T00:09:21Z","last_updated_date":"2009-11-23T00:09:21Z","reference_number":"EMEA/763788/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-irbesartan-bms-irbesartan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"6570","name":"Agenda - Meeting of the Paediatric Diabetes Mellitus Experts Group","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-05-06T02:00:00Z","last_updated_date":"2010-05-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-meeting-paediatric-diabetes-mellitus-experts-group_en.pdf"},
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    {"id":"6578","name":"Retinoid Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/459912/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-review-started_en.pdf"},
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    {"id":"6611","name":"Minutes of the 98th meeting of the Management Board: 13-14 December 2017","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2018-02-27T12:45:00Z","last_updated_date":"2018-02-27T12:45:00Z","reference_number":"EMA/MB/701078/2017 ","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-98th-meeting-management-board-13-14-december-2017_en.pdf"},
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    {"id":"6615","name":"Management Board completes framework for conflicts of interests","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-08T14:00:00Z","last_updated_date":"2012-06-08T14:00:00Z","reference_number":"EMA/391894/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/management-board-completes-framework-conflicts-interests_en.pdf"},
    {"id":"6617","name":"European Medicines Agency recommends restricted use of\n\nnimesulide-containing medicinal products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-09-21T02:09:21Z","last_updated_date":"2007-09-21T02:09:21Z","reference_number":"EMEA/432604/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricted-use-nimesulide-containing-medicinal-products_en.pdf"},
    {"id":"6618","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Protelos (strontium ranelate)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/232003/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-protelos-strontium-ranelate_sv.pdf"}},
    {"id":"6621","name":"Kogenate Bayer and Helixate NexGen Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-03-08T01:00:00Z","reference_number":"EMA/136663/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-review-started_en.pdf"},
    {"id":"6622","name":"Letter from the Food and Drug Administration to the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2003-09-12T02:00:00Z","last_updated_date":"2003-09-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-food-and-drug-administration-european-commission_en.pdf"},
    {"id":"6623","name":"Committee for medicinal products for human use, summary of positive opinion for Repaglinide Krka","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-repaglinide-krka_en.pdf"},
    {"id":"6624","name":"Intravenous iron-containing medicinal products Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-01T02:00:00Z","last_updated_date":"2013-10-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"6625","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 June 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-07-13T13:40:00Z","last_updated_date":"2017-07-13T13:40:00Z","reference_number":"EMA/PDCO/400324/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-20-23-june-2017_en.pdf"},
    {"id":"6626","name":"Final assessment report on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/HMPC/627058/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"6627","name":"Chapter 1: Introduction of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-01T21:19:00Z","last_updated_date":"2012-03-05T12:00:00Z","reference_number":"EMA/717178/2011","document_url":"https://www.ema.europa.eu/en/documents/other/chapter-1-introduction-detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf"},
    {"id":"6629","name":"Public statement Fluenz: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-12-03T01:00:00Z","last_updated_date":"2014-12-03T01:00:00Z","reference_number":"EMA/622936/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-fluenz-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"6630","name":"Saroten Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"EMA/255467/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/saroten-article-30-referral-assessment-report_en.pdf"},
    {"id":"6631","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Addendum to PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-15T14:00:00Z","last_updated_date":"2016-04-15T14:00:00Z","reference_number":"EMA/PRAC/196081/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-addendum-prac-list-questions_en.pdf"},
    {"id":"6633","name":"European Medicines Agency finalises review of antidepressants in children\n\nand adolescents","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2005-04-25T02:08:21Z","last_updated_date":"2005-04-25T02:08:21Z","reference_number":"EMEA/CHMP/128918/2005 corr","document_url":"https://www.ema.europa.eu/en/documents/referral/european-medicines-agency-finalises-review-antidepressants-children-and-adolescents_en.pdf"},
    {"id":"6634","name":"Summary report - Workshop on nanomedicines: 2-3 September 2010","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/538503/2010","document_url":"https://www.ema.europa.eu/en/documents/report/summary-report-workshop-nanomedicines-2-3-september-2010_en.pdf"},
    {"id":"6635","name":"Opinion of the CVMP on the establishment of maximum residue limits: Lufenuron","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-02-04T11:10:00Z","last_updated_date":"2015-02-04T11:10:00Z","reference_number":"EMA/CVMP/651823/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-lufenuron_en.pdf"},
    {"id":"6637","name":"Management Board started building approval process of EMA premises in Amsterdam","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"EMA/72752/2018 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/management-board-started-building-approval-process-ema-premises-amsterdam_en.pdf"},
    {"id":"6638","name":"Supersede list of references supporting the assessment of Olea europaea L., folium - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-04-18T17:30:00Z","last_updated_date":"2012-04-18T17:30:00Z","reference_number":"EMA/HMPC/430505/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/supersede-list-references-supporting-assessment-olea-europaea-l-folium-first-version_en.pdf"},
    {"id":"6639","name":"EU/3/06/395: Public summary of positive opinion for orphan designation of aviptadil for the treatment of acute lung injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/187221/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306395-public-summary-positive-opinion-orphan-designation-aviptadil-treatment-acute-lung-injury_en.pdf"},
    {"id":"6640","name":"CHMP post-authorisation summary of positive opinion for Arcalyst","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-07-23T02:09:21Z","last_updated_date":"2009-07-23T02:09:21Z","reference_number":"EMEA/CHMP/346815/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-arcalyst_en.pdf"},
    {"id":"6641","name":"Presentation - ATMPs classification (Belaà¯d Sekkali)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-12T19:00:00Z","last_updated_date":"2015-05-12T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-atmps-classification-belaa-d-sekkali_en.pdf"},
    {"id":"6642","name":"Proposals to revise guidance on first-in-human clinical trials","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-21T14:00:00Z","last_updated_date":"2016-07-21T14:00:00Z","reference_number":"EMA/485860/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/proposals-revise-guidance-first-human-clinical-trials_en.pdf"},
    {"id":"6643","name":"EU/3/16/1826: Public summary of opinion on orphan designation: Recombinant IgG degrading enzyme of Streptococcus pyogenes for the prevention of graft rejection following solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/15862/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161826-public-summary-opinion-orphan-designation-recombinant-igg-degrading-enzyme-streptococcus-pyogenes-prevention-graft-rejection-following-solid-organ-transplantation_en.pdf"},
    {"id":"6647","name":"Download EPS - Species pictograms - Pig","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-pig_en.zip"},
    {"id":"6648","name":"Presentation - Clinical trials in community-acquired pneumonia (CAP) (Francesco Blasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-community-acquired-pneumonia-cap-francesco-blasi_en.pdf"},
    {"id":"6649","name":"Agenda - European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) stakeholders annual meeting 2017","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-surveillance-veterinary-antimicrobial-consumption-esvac-stakeholders-annual-meeting-2017_en.pdf"},
    {"id":"6650","name":"Human menopausal urinary gonadotrophin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/human-menopausal-urinary-gonadotrophin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6651","name":"Adopted guideline on setting specifications for related impurities in antibiotics","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-07-13T13:00:00Z","last_updated_date":"2012-07-13T13:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/199250/2009 corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/adopted-guideline-setting-specifications-related-impurities-antibiotics_en.pdf"},
    {"id":"6653","name":"Draft list of references supporting the assessment of Althaea officinalis L., radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-12-11T18:20:00Z","last_updated_date":"2015-12-11T18:20:00Z","reference_number":"EMA/HMPC/436678/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-althaea-officinalis-l-radix_en.pdf"},
    {"id":"6655","name":"General Court finds no fault in 2011 appointment procedure of EMA Executive Director","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T14:00:00Z","last_updated_date":"2017-10-03T14:00:00Z","reference_number":"EMA/648085/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/general-court-finds-no-fault-2011-appointment-procedure-ema-executive-director_en.pdf"},
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    {"id":"6671","name":"Presentation - Current issues on quality of phage products (Alan Fauconnier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-issues-quality-phage-products-alan-fauconnier_en.pdf"},
    {"id":"6672","name":"EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/577812/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-confirms-positive-benefit-risk-antidepressant-valdoxanthymanax-agomelatine_en.pdf"},
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    {"id":"6676","name":"CHMP summary of positive opinion for Ifirmacombi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/646092/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ifirmacombi_en.pdf"},
    {"id":"6677","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Deltyba (delamanid) for the treatment of tuberculosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/COMP/2642/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-deltyba-delamanid-treatment-tuberculosis_en.pdf"},
    {"id":"6680","name":"EU Clinical Trials Register goes live","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-03-23T00:31:00Z","last_updated_date":"2011-03-23T00:31:00Z","reference_number":"EMA/199558/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-clinical-trials-register-goes-live_en.pdf"},
    {"id":"6681","name":"Public ICH Regional Meeting - Welcome","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/public-ich-regional-meeting-welcome_en.pdf"},
    {"id":"6683","name":"Draft assessment report on Hieracium pilosella L., herba","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-08-04T02:00:00Z","last_updated_date":"2014-08-04T02:00:00Z","reference_number":"EMA/HMPC/680373/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-hieracium-pilosella-l-herba_en.pdf"},
    {"id":"6684","name":"Presentation - Brainstorming on targeting European Medicines Agency information to patients and healthcare professionals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-brainstorming-targeting-european-medicines-agency-information-patients-and-healthcare-professionals_en.pdf"},
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    {"id":"6689","name":"Agenda - Third industry stakeholder platform on the operation of European Union pharmacovigilance legislation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"EMA/56551/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-third-industry-stakeholder-platform-operation-european-union-pharmacovigilance-legislation_en.pdf"},
    {"id":"6691","name":"EU/3/11/909: Public summary of opinion on orphan designation: Macitentan for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2015-03-23T17:00:00Z","reference_number":"EMA/COMP/635474/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311909-public-summary-opinion-orphan-designation-macitentan-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"6692","name":"What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2017-08-09T15:55:00Z","last_updated_date":"2017-08-09T15:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-2-2017_en.pdf"},
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    {"id":"6714","name":"European Medicines Agency recommends new anti-malaria treatment for use outside the European Union","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T12:57:21Z","last_updated_date":"2012-02-17T12:57:21Z","reference_number":"EMA/CHMP/114875/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-new-anti-malaria-treatment-use-outside-european-union_en.pdf"},
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    {"id":"6717","name":"Ipratropium/salbutamol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"6718","name":"Committee for proprietary medicinal products September 2001 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2001-09-25T02:00:00Z","last_updated_date":"2001-09-25T02:00:00Z","reference_number":"CPMP/2936/01","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-september-2001-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"6723","name":"Public statement on Somatropin Biopartners: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T17:20:00Z","last_updated_date":"2017-12-01T17:20:00Z","reference_number":"EMA/791271/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-somatropin-biopartners-cessation-validity-marketing-authorisation-european-union_en.pdf"},
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    {"id":"6733","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 April 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-04-16T02:00:00Z","last_updated_date":"2012-04-16T02:00:00Z","reference_number":"EMA/CVMP/221484/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-april-2012_en.pdf"},
    {"id":"6736","name":"Press release: Committee for Orphan Medicinal Products January 2007 Meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2007-01-10T00:09:21Z","last_updated_date":"2007-01-10T00:09:21Z","reference_number":"EMEA/COMP/7953/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-committee-orphan-medicinal-products-january-2007-meeting_en.pdf"},
    {"id":"6741","name":"Esmya Article-20 procedure - Esmya: new measures to minimise risk of rare but serious liver injury","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T02:00:00Z","last_updated_date":"2018-06-01T02:00:00Z","reference_number":"EMA/355940/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/esmya-article-20-procedure-esmya-new-measures-minimise-risk-rare-serious-liver-injury_en.pdf"},
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    {"id":"6743","name":"Sandimmun Neoral Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T12:00:00Z","last_updated_date":"2013-12-20T12:00:00Z","reference_number":"EMEA/H/A-30/1300","document_url":"https://www.ema.europa.eu/en/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sandimmun-neoral-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"6744","name":"Presentation - European Union experiences with patient reporting","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:06Z","last_updated_date":"2011-06-24T22:06:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-union-experiences-patient-reporting_en.pdf"},
    {"id":"6747","name":"Final assessment report on Sambucus nigra L., flos - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-06-27T17:00:00Z","last_updated_date":"2018-06-27T17:00:00Z","reference_number":"EMA/HMPC/611504/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-sambucus-nigra-l-flos-revision-1_en.pdf"},
    {"id":"6748","name":"Guideline on the clinical development of medicinal products for the treatment of allergic rhino-conjunctivitis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-10-21T02:00:00Z","last_updated_date":"2004-10-21T02:00:00Z","reference_number":"CHMP/EWP/2455/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-medicinal-products-treatment-allergic-rhino-conjunctivitis_en.pdf"},
    {"id":"6750","name":"Agenda - PDA/EMA 2011 Conference - Regulation, Cooperation, Innovation: An Effective Partnership among Authorities and Industry in Europe","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-03-17T01:00:00Z","last_updated_date":"2011-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pdaema-2011-conference-regulation-cooperation-innovation-effective-partnership-among-authorities-and-industry-europe_en.pdf"},
    {"id":"6751","name":"CHMP statistics: October 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-october-2016_en.pdf"},
    {"id":"6754","name":"Agenda - Veterinary Focus Group Meeting - CVMP Bioequivalence Guideline (Revision)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-05-06T02:09:21Z","last_updated_date":"2009-05-06T02:09:21Z","reference_number":"EMEA/CVMP/98792/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-veterinary-focus-group-meeting-cvmp-bioequivalence-guideline-revision_en.pdf"},
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    {"id":"6756","name":"Presentation - EMA's first public hearing (N. Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:44:00Z","last_updated_date":"2017-12-11T16:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-first-public-hearing-n-bere_en.pdf"},
    {"id":"6759","name":"Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot and mouth disease (FMD) - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2009-03-16T01:00:00Z","reference_number":"EMEA/CVMP/IWP/105506/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-first-version_en.pdf"},
    {"id":"6761","name":"Tetrazepam-containing medicines Article-107i procedure - PRAC recommends suspension of tetrazepam-containing medicines: Questions and answers","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-12T14:00:00Z","last_updated_date":"2013-04-12T14:00:00Z","reference_number":"EMA/225675/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-prac-recommends-suspension-tetrazepam-containing-medicines-questions-and-answers_en.pdf"},
    {"id":"6765","name":"Mebendazole: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/625/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/mebendazole-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6767","name":"Presentation - Do we have a common understanding of medication errors? (Jeffrey Aronson, Robin Ferner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-do-we-have-common-understanding-medication-errors-jeffrey-aronson-robin-ferner_en.pdf"},
    {"id":"6768","name":"Prulifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation  - 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    {"id":"6769","name":"Presentation - European Medicines Agency product team and applicant/marketing authorisation holder interaction (Michael Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T02:00:00Z","last_updated_date":"2015-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-product-team-and-applicantmarketing-authorisation-holder-interaction-michael-berntgen_en.pdf"},
    {"id":"6770","name":"Withdrawal assessment report for Biferonex","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-08-06T02:00:00Z","last_updated_date":"2009-08-06T02:00:00Z","reference_number":"EMEA/334517/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-biferonex_en.pdf"},
    {"id":"6771","name":"Pharmacokinetic studies in man","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-02-01T01:00:00Z","last_updated_date":"2015-02-01T01:00:00Z","reference_number":"3CC3a","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/pharmacokinetic-studies-man_en.pdf"},
    {"id":"6777","name":"Amlodipine / atorvastatine: List of nationally authorised medicinal products - PSUSA/00000177/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T19:35:00Z","last_updated_date":"2016-10-19T19:35:00Z","reference_number":"EMA/662266/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-atorvastatine-list-nationally-authorised-medicinal-products-psusa00000177201601_en.pdf"},
    {"id":"6778","name":"Presentation - Feedback from the European Network of Paediatric Research at the European Medicines Agency workshop: Background information","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-european-network-paediatric-research-european-medicines-agency-workshop-background-information_en.pdf"},
    {"id":"6780","name":"Rise in applications for medicines in 2006, concerns over budget situation for 2007 and new transparency measures","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-10-06T02:09:21Z","last_updated_date":"2006-10-06T02:09:21Z","reference_number":"EMEA/388563/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/rise-applications-medicines-2006-concerns-over-budget-situation-2007-and-new-transparency-measures_en.pdf"},
    {"id":"6781","name":"Workshop on medicines for bees - Report from breakout session 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/workshop-medicines-bees-report-breakout-session-2_en.pdf"},
    {"id":"6782","name":"Presentation - Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products – an update (Christiane Niederlaender)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-quality-non-clinical-and-clinical-aspects-gene-therapy-medicinal-products-update-christiane-niederlaender_en.pdf"},
    {"id":"6786","name":"ICH: Q 4 B Annex 3: To note for evaluation and recommendation of pharmacopoeial texts for use in the ich regions on test for particulate contamination: Sub-visible particles general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-11-01T01:00:00Z","last_updated_date":"2007-11-01T01:00:00Z","reference_number":"EMEA/CHMP/ICH/561176/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-3-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-test-particulate-contamination-sub-visible-particles-general-chapter-step-3_en.pdf"},
    {"id":"6789","name":"Flyer - The annual European Medicines Agency review of the year and outlook for 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-27T02:00:00Z","last_updated_date":"2011-10-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/flyer-annual-european-medicines-agency-review-year-and-outlook-2012_en.pdf"},
    {"id":"6790","name":"Gadobenic acid: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001500/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T01:00:00Z","last_updated_date":"2016-10-19T12:37:32Z","reference_number":"EMA/182023/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadobenic-acid-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001500201504_en.pdf"},
    {"id":"6791","name":"Guidelines and concept papers adopted during the CHMP meeting 22-25 September 2014","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2014-10-13T16:00:00Z","last_updated_date":"2014-10-13T16:00:00Z","reference_number":"EMA/CHMP/129673/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-22-25-september-2014_en.pdf"},
    {"id":"6792","name":"Opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine and Pseudoephedrine hydrochloride and Annexes A and B","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-01-22T00:08:21Z","last_updated_date":"1998-01-22T00:08:21Z","reference_number":"CPMP/1001/97-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-and-pseudoephedrine-hydrochloride-and-annexes-and-b_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-and-pseudoephedrine-hydrochloride-and-annexes-and-b_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-and-pseudoephedrine-hydrochloride-and-annexes-and-b_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-and-pseudoephedrine-hydrochloride-and-annexes-and-b_fr.pdf"}},
    {"id":"6793","name":"Call for submission of scientific data relating to the assessment of Hederae helices folium Hedera helix l., folium (ivy leaf)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2008-11-15T01:00:00Z","last_updated_date":"2008-11-15T01:00:00Z","reference_number":"EMEA/HMPC/617260/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-hederae-helices-folium-hedera-helix-l-folium-ivy-leaf_en.pdf"},
    {"id":"6794","name":"Gaxilose: List of nationally authorised medicinal products - PSUSA/00010283/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T17:20:00Z","last_updated_date":"2017-09-06T17:20:00Z","reference_number":"EMA/524602/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/gaxilose-list-nationally-authorised-medicinal-products-psusa00010283201701_en.pdf"},
    {"id":"6795","name":"EU/3/16/1619: Public summary of opinion on orphan designation: DNA plasmid encoding a recombinant fusion protein consisting of the extracellular domain of human TNFα p55 receptor linked to the human IgG1 Fc domain for t...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/61236/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161619-public-summary-opinion-orphan-designation-dna-plasmid-encoding-recombinant-fusion-protein-consisting-extracellular-domain-human-tnfi-p55-receptor-linked-human-igg1-fc-domain-t_en.pdf"},
    {"id":"6797","name":"Overview of the EudraVigilance training on electronic reporting of ICSRs in the EEA: 10-11 March 2014, London, UK","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/overview-eudravigilance-training-electronic-reporting-icsrs-eea-10-11-march-2014-london-uk_en.pdf"},
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    {"id":"6800","name":"Presentation - Alternatives provided by recent system modelling in animal health for the upscaling of vaccine efficacy (H. Thulke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T14:30:00Z","last_updated_date":"2017-11-16T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-alternatives-provided-recent-system-modelling-animal-health-upscaling-vaccine-efficacy-h-thulke_en.pdf"},
    {"id":"6802","name":"Withdrawal assessment report for Corluxin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-06-12T17:00:00Z","last_updated_date":"2015-06-12T17:00:00Z","reference_number":"EMA/235012/2015","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-corluxin_en.pdf"},
    {"id":"6803","name":"Diacerein Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-19T02:00:00Z","last_updated_date":"2014-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diacerein-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diacerein-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diacerein-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diacerein-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diacerein-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diacerein-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diacerein-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diacerein-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/diacerein-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diacerein-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diacerein-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diacerein-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diacerein-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diacerein-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diacerein-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diacerein-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diacerein-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diacerein-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diacerein-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diacerein-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diacerein-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diacerein-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"6804","name":"EU/3/01/083: Public summary of positive opinion for orphan designation of adenovirus-mediated Herpes simplex virus - thymidine kinase (HSV-tk) gene for the treatment of high-grade glioma with subsequent use of ganciclovi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-06T01:00:00Z","last_updated_date":"2014-04-01T14:30:00Z","reference_number":"EMA/COMP/68/02 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301083-public-summary-positive-opinion-orphan-designation-adenovirus-mediated-herpes-simplex-virus-thymidine-kinase-hsv-tk-gene-treatment-high-grade-glioma-subsequent-use-ganciclovi_en.pdf"},
    {"id":"6805","name":"Frequently asked questions relating to the assignment and maintenance of micro-, small- or medium-sized-enterprise status by the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T02:00:00Z","last_updated_date":"2010-12-17T02:00:00Z","reference_number":"EMA/796232/2010","document_url":"https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-relating-assignment-and-maintenance-micro-small-or-medium-sized-enterprise-status-european-medicines-agency_en.pdf"},
    {"id":"6807","name":"Kantos Master Article-13 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-02T12:00:00Z","last_updated_date":"2013-05-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kantos-master-article-13-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kantos-master-article-13-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kantos-master-article-13-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kantos-master-article-13-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kantos-master-article-13-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kantos-master-article-13-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kantos-master-article-13-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kantos-master-article-13-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kantos-master-article-13-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kantos-master-article-13-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kantos-master-article-13-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kantos-master-article-13-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kantos-master-article-13-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kantos-master-article-13-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kantos-master-article-13-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kantos-master-article-13-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kantos-master-article-13-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kantos-master-article-13-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kantos-master-article-13-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kantos-master-article-13-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kantos-master-article-13-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kantos-master-article-13-referral-annex-iii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/kantos-master-article-13-referral-annex-iii_no.pdf"}},
    {"id":"6808","name":"Public statement on Pantecta Control: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T17:41:00Z","last_updated_date":"2016-11-15T17:41:00Z","reference_number":"EMEA/H/C/001099","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pantecta-control-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"6810","name":"Survey 2007 on the performance of EMEA scientific procedures for medicinal products for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:09:21Z","last_updated_date":"2008-04-24T02:09:21Z","reference_number":"EMEA/158877/2008","document_url":"https://www.ema.europa.eu/en/documents/other/survey-2007-performance-emea-scientific-procedures-medicinal-products-human-use_en.pdf"},
    {"id":"6812","name":"Presentation - Session 4: Accuracy of diagnostic methods and impact on clinical management : the lymphopath network experience (Philippe Gaulard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-accuracy-diagnostic-methods-and-impact-clinical-management-lymphopath-network-experience-philippe-gaulard_en.pdf"},
    {"id":"6813","name":"EU/3/12/976: Public summary of opinion on orphan designation: Antisense oligonucleotide targeted to the SMN2 gene for the treatment of 5q spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-04-30T02:00:00Z","reference_number":"EMA/COMP/136041/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312976-public-summary-opinion-orphan-designation-antisense-oligonucleotide-targeted-smn2-gene-treatment-5q-spinal-muscular-atrophy_en.pdf"},
    {"id":"6816","name":"Standard Operating Procedure for marketing status reporting and sunset clause monitoring (Human Medicine)","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-04-25T02:00:00Z","last_updated_date":"2008-04-25T02:00:00Z","reference_number":"SOP/H/3128","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-marketing-status-reporting-and-sunset-clause-monitoring-human-medicine_en.pdf"},
    {"id":"6818","name":"EU/3/17/1901: Public summary of opinion on orphan designation: Itraconazole for the treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2023-07-27T02:00:00Z","reference_number":"EMA/475685/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171901-public-summary-opinion-orphan-designation-itraconazole-treatment-naevoid-basal-cell-carcinoma-syndrome-gorlin-syndrome_en.pdf"},
    {"id":"6819","name":"European Medicines Agency and its international partners complete successful inspection pilots","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-08-02T17:54:23Z","last_updated_date":"2011-08-02T17:54:23Z","reference_number":"EMA/612563/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-its-international-partners-complete-successful-inspection-pilots_en.pdf"},
    {"id":"6822","name":"Altrenogest: Summary Report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-02-01T01:00:00Z","last_updated_date":"2002-02-01T01:00:00Z","reference_number":"EMEA/MRL/831/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/altrenogest-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6823","name":"EU/3/10/789: Public summary of opinion on orphan designation: 16-base single-stranded peptide nucleic acid oligonucleotide linked to a 7-amino acid peptide for the treatment of medulloblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2014-04-01T18:00:00Z","reference_number":"EMA/COMP/483832/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310789-public-summary-opinion-orphan-designation-16-base-single-stranded-peptide-nucleic-acid-oligonucleotide-linked-7-amino-acid-peptide-treatment-medulloblastoma_en.pdf"},
    {"id":"6824","name":"Valproate Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/198940/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"6825","name":"Guidance on format of the risk-management plan in the European Union part II: Module SII - Non-clinical part of the safety specification","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2013-08-21T02:00:00Z","reference_number":"EMA/465926/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-sii-non-clinical-part-safety-specification_en.doc"},
    {"id":"6827","name":"Bromocriptine Article-31 referral - CMDh endorses restricted use of bromocriptine for stopping breast milk production","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-21T02:00:00Z","last_updated_date":"2014-08-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-cmdh-endorses-restricted-use-bromocriptine-stopping-breast-milk-production_en.pdf"},
    {"id":"6828","name":"Scientific aspects and working definitions for the mandatory scope of the centralised procedure","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-12-13T01:00:00Z","last_updated_date":"2007-12-13T01:00:00Z","reference_number":"EMEA/CHMP/121944/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/scientific-aspects-and-working-definitions-mandatory-scope-centralised-procedure_en.pdf"},
    {"id":"6830","name":"Presentation - Continuous progress in the area of paediatrics (E. Desfontaine, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-23T01:00:00Z","last_updated_date":"2017-11-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-continuous-progress-area-paediatrics-e-desfontaine-ema_en.pdf"},
    {"id":"6832","name":"Draft list of references supporting the assessment of Pelargonium sidoides DC and / or Pelargonium reniforme Curt., radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-10-26T01:00:00Z","last_updated_date":"2015-10-26T01:00:00Z","reference_number":"EMA/HMPC/444243/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-pelargonium-sidoides-dc-and-or-pelargonium-reniforme-curt-radix_en.pdf"},
    {"id":"6833","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Naloxone (hydrochloride) for treatment of opioid-induced constipation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T12:15:00Z","last_updated_date":"2014-12-12T12:15:00Z","reference_number":"EMA/461583/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-naloxone-hydrochloride-treatment-opioid-induced-constipation_en.pdf"},
    {"id":"6835","name":"Overview of comments received on guideline on repeated dose toxicity (CPMP/SWP/1042/99 Rev 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-29T02:00:00Z","last_updated_date":"2010-11-05T01:00:00Z","reference_number":"EMA/402716/2008 Correction","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-repeated-dose-toxicity-cpmpswp104299-rev-1_en.pdf"},
    {"id":"6836","name":"Agenda – follow up information session on the TransCelerate initiative","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-06-16T02:00:00Z","last_updated_date":"2016-06-16T02:00:00Z","reference_number":"EMA/419751/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-follow-information-session-transcelerate-initiative_en.pdf"},
    {"id":"6840","name":"Note for guidance on antiarrhythmics","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-01T01:00:00Z","last_updated_date":"2005-11-01T01:00:00Z","reference_number":"CPMP/EWP/237/95 final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-antiarrhythmics_en.pdf"},
    {"id":"6846","name":"EU/3/08/536: Public summary of positive opinion for orphan designation of chimeric antibody to mesothelin for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2016-08-11T02:00:00Z","reference_number":"EMEA/COMP/72873/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308536-public-summary-positive-opinion-orphan-designation-chimeric-antibody-mesothelin-treatment-pancreatic-cancer_en.pdf"},
    {"id":"6848","name":"Streamlining EMA public communication on medication errors","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-27T11:00:00Z","last_updated_date":"2015-11-27T11:00:00Z","reference_number":"EMA/787897/2015","document_url":"https://www.ema.europa.eu/en/documents/other/streamlining-ema-public-communication-medication-errors_en.pdf"},
    {"id":"6849","name":"Public summary of opinion on orphan designation: Zoledronic acid for the treatment of complex regional pain syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/COMP/102965/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-zoledronic-acid-treatment-complex-regional-pain-syndrome_en.pdf"},
    {"id":"6850","name":"CHMP summary of positive opinion for Lifmior","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T15:02:00Z","last_updated_date":"2020-02-20T15:02:00Z","reference_number":"EMA/CHMP/764586/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lifmior_en.pdf"},
    {"id":"6852","name":"EU/3/01/023: Public summary of positive opinion for orphan designation of pegvisomant for the treatment of acromegaly","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T00:00:00Z","last_updated_date":"2013-02-27T13:00:00Z","reference_number":"EMEA/COMP/1282/03 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301023-public-summary-positive-opinion-orphan-designation-pegvisomant-treatment-acromegaly_en.pdf"},
    {"id":"6853","name":"CVMP summary of positive opinion for Purevax Rabies","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2010-12-10T01:00:00Z","reference_number":"EMA/CVMP/144109/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-purevax-rabies_en.pdf"},
    {"id":"6854","name":"Work programme of the European Medicines Agency 2012","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T15:20:00Z","last_updated_date":"2012-02-17T15:20:00Z","reference_number":"EMA/MB/554514/2011","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-medicines-agency-2012_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/work-programme/work-programme-european-medicines-agency-2012_bg.pdf","es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-medicines-agency-2012_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/work-programme/work-programme-european-medicines-agency-2012_cs.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/work-programme-european-medicines-agency-2012_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-medicines-agency-2012_de.pdf","et":"https://www.ema.europa.eu/et/documents/work-programme/work-programme-european-medicines-agency-2012_et.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/work-programme-european-medicines-agency-2012_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-medicines-agency-2012_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/work-programme-european-medicines-agency-2012_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/work-programme/work-programme-european-medicines-agency-2012_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/work-programme/work-programme-european-medicines-agency-2012_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/work-programme/work-programme-european-medicines-agency-2012_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/work-programme/work-programme-european-medicines-agency-2012_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/work-programme-european-medicines-agency-2012_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/work-programme/work-programme-european-medicines-agency-2012_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/work-programme/work-programme-european-medicines-agency-2012_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/work-programme/work-programme-european-medicines-agency-2012_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/work-programme/work-programme-european-medicines-agency-2012_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/work-programme/work-programme-european-medicines-agency-2012_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/work-programme-european-medicines-agency-2012_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/work-programme-european-medicines-agency-2012_sv.pdf"}},
    {"id":"6858","name":"Volume 3b guidelines: Medicinal products for human use: Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-07-01T02:00:00Z","last_updated_date":"2003-07-01T02:00:00Z","reference_number":"3bc7a","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/volume-3b-guidelines-medicinal-products-human-use-safety-environment-and-information-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"6859","name":"Adempas : Product Information as approved by the CHMP on 23 June 2016, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/adempas-product-information-approved-chmp-23-june-2016-pending-endorsement-european-commission_en.pdf"},
    {"id":"6864","name":"Requirements for gene therapy products: Non-clinical and clinical aspects - Gopalan Narayanan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/requirements-gene-therapy-products-non-clinical-and-clinical-aspects-gopalan-narayanan_en.pdf"},
    {"id":"6867","name":"Withdrawal assessment report for Zubrin – oral suspension","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T01:00:00Z","last_updated_date":"2009-02-24T01:00:00Z","reference_number":"EMEA/46907/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zubrin-oral-suspension_en.pdf"},
    {"id":"6868","name":"Background review for the excipient propylene glycol: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T18:20:00Z","last_updated_date":"2014-12-01T18:20:00Z","reference_number":"EMA/CHMP/334655/2013","document_url":"https://www.ema.europa.eu/en/documents/report/background-review-excipient-propylene-glycol-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-draft-report_en.pdf"},
    {"id":"6870","name":"Presentation - Mapping EU initiatives on electronic product information - EMA's PCWP and HCPWP joint meeting (Cà©sar Hernà¡ndez Garcà­a)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mapping-eu-initiatives-electronic-product-information-emas-pcwp-and-hcpwp-joint-meeting-cacsar-hernandez-garca_en.pdf"},
    {"id":"6873","name":"EU/3/13/1197: Public summary of opinion on orphan designation: Autologous ex-vivo-expanded leucocytes treated with 5-aza-2’-deoxycytidine for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-11-28T01:00:00Z","last_updated_date":"2013-11-28T01:00:00Z","reference_number":"EMA/COMP/627216/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131197-public-summary-opinion-orphan-designation-autologous-ex-vivo-expanded-leucocytes-treated-5-aza-2-deoxycytidine-treatment-glioma_en.pdf"},
    {"id":"6876","name":"EU/3/06/376: Public summary of positive opinion for orphan designation of recombinant P-selectin glycoprotein immunoglobulin for the prevention of post transplantation graft dysfunction","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T00:00:00Z","last_updated_date":"2011-06-01T01:00:00Z","reference_number":"EMEA/COMP/133194/2006draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306376-public-summary-positive-opinion-orphan-designation-recombinant-p-selectin-glycoprotein-immunoglobulin-prevention-post-transplantation-graft-dysfunction_en.pdf"},
    {"id":"6879","name":"CHMP summary of positive opinion for Clopidogrel Acino Pharma GmbH","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2009-06-25T02:09:21Z","reference_number":"EMEA/CHMP/376524/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-clopidogrel-acino-pharma-gmbh_en.pdf"},
    {"id":"6880","name":"Atovaquone: List of nationally authorised medicinal products - PSUSA/00000265/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-15T02:00:00Z","last_updated_date":"2016-10-17T19:40:06Z","reference_number":"EMA/681035/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/atovaquone-list-nationally-authorised-medicinal-products-psusa00000265201411_en.pdf"},
    {"id":"6882","name":"The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-23T02:09:21Z","last_updated_date":"2008-10-23T02:09:21Z","reference_number":"EMEA/CHMP/537777/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-marketing-authorisation-acomplia_en.pdf"},
    {"id":"6885","name":"Final assessment report on Angelica sinensis (Oliv.) Diels, radix - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-25T01:00:00Z","last_updated_date":"2013-11-25T01:00:00Z","reference_number":"EMA/HMPC/614586/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
    {"id":"6888","name":"Draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-09-25T02:09:21Z","last_updated_date":"2008-09-25T02:09:21Z","reference_number":"EMEA/CHMP/PhVWP/503449/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-conduct-pharmacovigilance-vaccines-pre-and-post-exposure-prophylaxis-against-infectious-diseases_en.pdf"},
    {"id":"6893","name":"Manidipine: List of nationally authorised medicinal products - PSUSA/00001932/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-18T11:29:35Z","reference_number":"EMA/346082/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/manidipine-list-nationally-authorised-medicinal-products-psusa00001932201506_en.pdf"},
    {"id":"6894","name":"Spectinomycin: Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-09-01T02:00:00Z","last_updated_date":"2001-09-01T02:00:00Z","reference_number":"EMEA/MRL/802/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spectinomycin-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6895","name":"CHMP post-authorisation summary of positive opinion for MicardisPlus","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/CHMP/261191/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-micardisplus_en.pdf"},
    {"id":"6898","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2013 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T15:00:00Z","last_updated_date":"2013-05-31T15:00:00Z","reference_number":"EMA/CAT/323934/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-may-2013-meeting_en.pdf"},
    {"id":"6899","name":"CHMP summary of opinion for Amlodipine-Valsartan Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-01-29T01:00:00Z","reference_number":"EMA/CHMP/18049/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-amlodipine-valsartan-mylan_en.pdf"},
    {"id":"6901","name":"Amendments to Management Board implementing rules on the Agency’s fees in relation to inflation and extrapolation of MRLs effective from 1 April 2011 - \n\nManagement Board meeting 17 March 2011","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2011-03-29T02:00:00Z","reference_number":"EMA/MB/757388/2010","document_url":"https://www.ema.europa.eu/en/documents/other/amendments-management-board-implementing-rules-agencys-fees-relation-inflation-and-extrapolation-mrls-effective-1-april-2011-management-board-meeting-17-march-2011_en.pdf"},
    {"id":"6904","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Elbasvir for the treatment of chronic hepatitis C","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/783316/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-elbasvir-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"6905","name":"SGLT2 inhibitors Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-12T14:00:00Z","last_updated_date":"2015-06-12T14:00:00Z","reference_number":"EMA/390062/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-article-20-procedure-review-started_en.pdf"},
    {"id":"6906","name":"Draft community herbal monograph on Taraxacum officinale Weber ex Wigg., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-01-14T00:09:21Z","last_updated_date":"2009-01-14T00:09:21Z","reference_number":"EMEA/HMPC/579636/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-folium_en.pdf"},
    {"id":"6908","name":"EU/3/11/849: Public summary of positive opinion for orphan designation: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3, 4-dihydro-4-quinazolinyl} acetic acid for the preve...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2013-06-19T12:00:00Z","reference_number":"EMA/COMP/57753/2011 rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311849-public-summary-positive-opinion-orphan-designation-s-8-fluoro-2-24-3-methoxyphenyl-1-piperazinyl-3-2-methoxy-5-trifluoromethyl-phenyl-3-4-dihydro-4-quinazolinyl-acetic-acid-preve_en.pdf"},
    {"id":"6909","name":"Presentation - General considerations for accelerated access schemes (PRIME/adaptive/accelerated pathways) - Session 5 (Ronald Imhoff, Richard Keane)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-considerations-accelerated-access-schemes-primeadaptiveaccelerated-pathways-session-5-ronald-imhoff-richard-keane_en.pdf"},
    {"id":"6910","name":"EU/3/13/1146: Public summary of opinion on orphan designation: Unoprostone isopropyl for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T14:00:00Z","last_updated_date":"2016-08-11T14:00:00Z","reference_number":"EMA/COMP/318070/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131146-public-summary-opinion-orphan-designation-unoprostone-isopropyl-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"6912","name":"Committee for proprietary medicinal products November 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-11-28T01:00:00Z","last_updated_date":"2002-11-28T01:00:00Z","reference_number":"EMEA/CPMP/5857/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-november-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"6913","name":"Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with finalisation of modules III and IV","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-13T17:00:00Z","last_updated_date":"2012-12-13T17:00:00Z","reference_number":"EMA/798404/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-introductory-cover-note-last-updated-finalisation-modules-iii-and-iv_en.pdf"},
    {"id":"6914","name":"Overview of comments received on draft guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-02-01T01:00:00Z","last_updated_date":"2010-02-01T01:00:00Z","reference_number":"EMA/818496/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-used-treatment-osteoarthritis_en.pdf"},
    {"id":"6916","name":"International Coalition of Medicines Regulatory Authorities (ICMRA) fact sheet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-20T16:00:00Z","last_updated_date":"2014-11-20T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/international-coalition-medicines-regulatory-authorities-icmra-fact-sheet_en.pdf"},
    {"id":"6918","name":"First EMEA Workshop on Advanced Therapy Medicinal Products (ATMPs) - List of participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/first-emea-workshop-advanced-therapy-medicinal-products-atmps-list-participants_en.pdf"},
    {"id":"6919","name":"EU/3/13/1101: Public summary of positive opinion of progesterone for the treatment of moderate and severe traumatic brain injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T11:00:00Z","last_updated_date":"2014-10-16T12:00:00Z","reference_number":"EMA/COMP/29206/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131101-public-summary-positive-opinion-progesterone-treatment-moderate-and-severe-traumatic-brain-injury_en.pdf"},
    {"id":"6921","name":"Rafal Swierzewski (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/rafal-swierzewski-doi_en.pdf"},
    {"id":"6924","name":"Ergot derivatives Article-31 referral - Dihydroergocryptine - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iv_sv.pdf"}},
    {"id":"6926","name":"Presentation - Agenda point 2: Revised ESVAC strategy 2016-2020 (Jordi Torren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-point-2-revised-esvac-strategy-2016-2020-jordi-torren_en.pdf"},
    {"id":"6928","name":"EU/3/05/267: Public summary of positive opinion for orphan designation of (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccina...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2016-09-30T02:00:00Z","reference_number":"EMEA/COMP/216994/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305267-public-summary-positive-opinion-orphan-designation-z-n-2-diethylaminoethyl-5-5-fluoro-2-oxo-12-dihydro-3h-indol-3-ylidenemethyl-24-dimethyl-1h-pyrrole-3-carboxamide-s-2-hydroxysyccina_en.pdf"},
    {"id":"6929","name":"CHMP summary of opinion for Tagrisso","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/776644/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-tagrisso_en.pdf"},
    {"id":"6930","name":"New enzyme replacement therapy to treat rare genetic disorder alpha-mannosidosis in children and adults","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-01-26T13:00:00Z","reference_number":"EMA/CHMP/46083/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-enzyme-replacement-therapy-treat-rare-genetic-disorder-alpha-mannosidosis-children-and-adults_en.pdf"},
    {"id":"6933","name":"EU/3/08/584: Public summary of positive opinion for orphan designation of palifosfamide for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2016-01-14T01:00:00Z","reference_number":"EMEA/COMP/563399/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308584-public-summary-positive-opinion-orphan-designation-palifosfamide-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"6934","name":"Flupirtine-containing medicines Article-107i procedure - Restrictions in the use of flupirtine-containing medicines - CMDh endorses PRAC recommendation","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/384191/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-restrictions-use-flupirtine-containing-medicines-cmdh-endorses-prac-recommendation_en.pdf"},
    {"id":"6935","name":"Orlistat - Article 31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-21T01:00:00Z","last_updated_date":"2012-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/orlistat-article-31-referral-annex-ii_en.pdf"},
    {"id":"6936","name":"Minutes of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-12-18T13:00:00Z","last_updated_date":"2017-12-18T13:00:00Z","reference_number":"EMA/785044/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting_en.pdf"},
    {"id":"6939","name":"CVMP summary of positive opinion for Aftovaxpur DOE","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-05-17T02:00:00Z","last_updated_date":"2023-07-04T02:00:00Z","reference_number":"EMA/CVMP/257822/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-aftovaxpur-doe_en.pdf"},
    {"id":"6941","name":"Presentation - Is product / indication specific guidance already necessary and meaningful?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:47Z","last_updated_date":"2012-06-15T17:10:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-indication-specific-guidance-already-necessary-and-meaningful_en.pdf"},
    {"id":"6942","name":"PRIME: a two-year overview","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-05-07T17:30:00Z","last_updated_date":"2018-05-07T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prime-two-year-overview_en.pdf"},
    {"id":"6943","name":"Questions and answers on the withdrawal of the marketing authorisation application for Oncophage (vitespen)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-12-21T00:09:21Z","last_updated_date":"2009-12-21T00:09:21Z","reference_number":"EMA/830607/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-oncophage-vitespen_sv.pdf"}},
    {"id":"6948","name":"Zinbryta Article-20 referral - Summary of provisional measures","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-11-17T01:00:00Z","reference_number":"EMA/424159/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinbryta-article-20-referral-summary-provisional-measures_sv.pdf"}},
    {"id":"6951","name":"8-hydroxyquinoline: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-07-01T02:00:00Z","last_updated_date":"1998-07-01T02:00:00Z","reference_number":"EMEA/MRL/464/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/8-hydroxyquinoline-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"6952","name":"Initial notices for parallel distribution – October 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-11-10T13:10:00Z","last_updated_date":"2014-11-10T13:10:00Z","reference_number":"EMA/695965/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-october-2014_en.pdf"},
    {"id":"6956","name":"ICH Q8 Pharmaceutical Development, workshop: Quality by design in pharmaceutical development and manufacture - Stockholm 2006-03-28","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-07-21T02:00:00Z","last_updated_date":"2006-07-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ich-q8-pharmaceutical-development-workshop-quality-design-pharmaceutical-development-and-manufacture-stockholm-2006-03-28_en.pdf"},
    {"id":"6958","name":"Withdrawal assessment report for Folcepri","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-14T02:00:00Z","last_updated_date":"2014-08-14T02:00:00Z","reference_number":"EMA/CHMP/219148/2014","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-folcepri_en.pdf"},
    {"id":"6959","name":"European Medicines Agency workshop on medicines for older people - Invitation for expressions of interest","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T11:40:00Z","last_updated_date":"2011-10-28T11:40:00Z","reference_number":"EMA/826786/2011","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-workshop-medicines-older-people-invitation-expressions-interest_en.pdf"},
    {"id":"6960","name":"CVMP summary of positive opinion for Nobivac LeuFel","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T17:30:00Z","last_updated_date":"2017-09-08T17:30:00Z","reference_number":"EMA/CVMP/518494/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-nobivac-leufel_en.pdf"},
    {"id":"6962","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the September 2009 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-09-11T02:09:21Z","last_updated_date":"2009-09-11T02:09:21Z","reference_number":"EMEA/COMP/506723/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-september-2009-meeting_en.pdf"},
    {"id":"6963","name":"Overview of comments on European Union herbal monograph on Harpagophytum procumbens DC. and /or Harpagophytum zeyheri Decne., radix (EMA/HMPC/627057/2015)","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/HMPC/354205/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-european-union-herbal-monograph-harpagophytum-procumbens-dc-and-or-harpagophytum-zeyheri-decne-radix-emahmpc6270572015_en.pdf"},
    {"id":"6968","name":"Maximum residue limits for veterinary medicinal products - Jordi Torren Edo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/maximum-residue-limits-veterinary-medicinal-products-jordi-torren-edo_en.pdf"},
    {"id":"6969","name":"EU/3/16/1763: Public summary of positive opinion for orphan designation of tadekinig alfa for the treatment of haemophagocytic lymphohistiocytosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/615105/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161763-public-summary-positive-opinion-orphan-designation-tadekinig-alfa-treatment-haemophagocytic-lymphohistiocytosis_en.pdf"},
    {"id":"6971","name":"Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Tobi Podhaler (tobramycin) for the treatment of Pseudomonas aeruginosa lung infection in cys...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-10-10T15:32:00Z","last_updated_date":"2023-07-31T15:32:00Z","reference_number":"EMA/COMP/624961/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-addition-new-indications-marketing-authorisation-tobi-podhaler-tobramycin-treatment-pseudomonas-aeruginosa-lung-infection-cys_en.pdf"},
    {"id":"6973","name":"Questions and answers on the addition of a contraindication for Velcade (bortezomib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T01:00:00Z","last_updated_date":"2008-03-20T01:00:00Z","reference_number":"EMEA/CHMP/138387/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-addition-contraindication-velcade-bortezomib_en.pdf"},
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    {"id":"6975","name":"EU/3/15/1511: Public summary of opinion on orphan designation: Human plasminogen for the treatment of plasminogen deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/426689/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151511-public-summary-opinion-orphan-designation-human-plasminogen-treatment-plasminogen-deficiency_en.pdf"},
    {"id":"6976","name":"Public statement on Trevaclyn: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-05-16T02:00:00Z","last_updated_date":"2013-05-16T02:00:00Z","reference_number":"EMA/183315/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-trevaclyn-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"6977","name":"Flolan - Article 30 - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-09-14T02:00:00Z","last_updated_date":"2012-09-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flolan-article-30-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flolan-article-30-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flolan-article-30-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flolan-article-30-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flolan-article-30-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flolan-article-30-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flolan-article-30-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flolan-article-30-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flolan-article-30-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flolan-article-30-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flolan-article-30-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flolan-article-30-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flolan-article-30-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flolan-article-30-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flolan-article-30-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flolan-article-30-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flolan-article-30-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flolan-article-30-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flolan-article-30-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flolan-article-30-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flolan-article-30-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flolan-article-30-annex-ii_sv.pdf"}},
    {"id":"6978","name":"Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-23T12:25:00Z","last_updated_date":"2017-10-23T12:25:00Z","reference_number":"EMA/CVMP/QWP/3629/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-chemical-structure-and-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances-veterinary_en.pdf"},
    {"id":"6979","name":"Note for guidance pharmacovigilance of veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-07-15T02:00:00Z","last_updated_date":"1997-07-15T02:00:00Z","reference_number":"EMEA/CVMP/183/96 Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-pharmacovigilance-veterinary-medicinal-products_en.pdf"},
    {"id":"6981","name":"Presentation - SPIRIT (Standard Protocol Items for Randomized Trials) and CONSORT (Consolidated Standards of Reporting Trials) (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spirit-standard-protocol-items-randomized-trials-and-consort-consolidated-standards-reporting-trials-irmgard-eichler_en.pdf"},
    {"id":"6982","name":"Nasonex Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2015-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nasonex-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nasonex-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nasonex-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nasonex-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nasonex-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nasonex-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nasonex-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nasonex-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nasonex-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nasonex-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nasonex-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nasonex-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nasonex-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nasonex-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nasonex-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nasonex-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nasonex-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nasonex-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nasonex-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nasonex-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nasonex-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nasonex-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nasonex-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/nasonex-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/nasonex-article-30-referral-annex-iii_no.pdf"}},
    {"id":"6983","name":"Withdrawal assessment report for Erbitux","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-11-22T15:36:00Z","last_updated_date":"2012-11-22T15:36:00Z","reference_number":"EMA/CHMP/628005/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-erbitux_en.pdf"},
    {"id":"6984","name":"EU/3/17/1851: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype rh.10 expressing beta-galactosidase for the treatment of GM1 gangliosidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/152998/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171851-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-rh10-expressing-beta-galactosidase-treatment-gm1-gangliosidosis_en.pdf"},
    {"id":"6985","name":"Legal basis for collection of data","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/legal-basis-collection-data_en.pdf"},
    {"id":"6986","name":"Remeron - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-10-13T02:08:21Z","last_updated_date":"2008-10-13T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/remeron-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/remeron-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/remeron-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/remeron-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/remeron-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/remeron-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/remeron-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/remeron-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/remeron-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/remeron-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/remeron-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/remeron-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/remeron-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/remeron-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/remeron-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/remeron-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/remeron-article-30-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/remeron-article-30-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/remeron-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/remeron-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/remeron-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/remeron-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"6987","name":"Draft assessment report on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"EMA/HMPC/712648/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-myroxylon-balsamum-l-harms-var-pereirae-royle-harms-balsamum_en.pdf"},
    {"id":"6988","name":"Presentation - Periodic safety update report (PSUR) repository (Irene Rager)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-12T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-periodic-safety-update-report-psur-repository-irene-rager_en.pdf"},
    {"id":"6989","name":"Presentation - Consideration of some other specific indications: Bacteraemia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:48Z","last_updated_date":"2011-04-26T18:05:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-consideration-some-other-specific-indications-bacteraemia_en.pdf"},
    {"id":"6990","name":"EU/3/18/2023: Public summary of opinion on orphan designation: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-225-Actinium for the treatment of glioma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-24T11:27:00Z","last_updated_date":"2018-07-24T11:27:00Z","reference_number":"EMA/273099/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182023-public-summary-opinion-orphan-designation-h-arg-pro-lys-pro-gln-gln-phe-2thi-gly-leu-meto2-nh2-dota-225-actinium-treatment-glioma_en.pdf"},
    {"id":"6992","name":"EU/3/07/468: Public summary of positive opinion for orphan designation of dihydroartemisin, piperaquine for the treatment of malaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-07-29T02:00:00Z","last_updated_date":"2011-09-05T02:00:00Z","reference_number":"EMEA/COMP/97615/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307468-public-summary-positive-opinion-orphan-designation-dihydroartemisin-piperaquine-treatment-malaria_en.pdf"},
    {"id":"6993","name":"Presentation - How the European Medicines Agency works with healthcare professionals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T16:00:00Z","last_updated_date":"2016-02-15T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-european-medicines-agency-works-healthcare-professionals_en.pdf"},
    {"id":"6994","name":"Declaration of interests: Frances Nuttall","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:18Z","last_updated_date":"2012-08-02T12:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-frances-nuttall_en.pdf"},
    {"id":"6998","name":"Ginseng (Extension of use): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-09-01T02:00:00Z","last_updated_date":"2006-09-01T02:00:00Z","reference_number":"EMEA/CVMP/352217/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ginseng-extension-use-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7000","name":"Almitrine Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/750601/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-referral-review-started_en.pdf"},
    {"id":"7002","name":"Final assessment report on Cimicifuga racemosa (L.) Nutt., rhizome - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-07-03T02:00:00Z","last_updated_date":"2018-07-03T02:00:00Z","reference_number":"EMA/HMPC/48744/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-cimicifuga-racemosa-l-nutt-rhizome-revision-1_en.pdf"},
    {"id":"7003","name":"Questions and answers on the withdrawal of the marketing application for Lenalidomide Celgene Europe","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/294089/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-lenalidomide-celgene-europe_sv.pdf"}},
    {"id":"7004","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Avena sativa L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/305008/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-avena-sativa-l-herba_en.pdf"},
    {"id":"7005","name":"Overview of comments received on 'Guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T12:00:00Z","last_updated_date":"2016-03-11T12:00:00Z","reference_number":"EMA/30262/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-duchenne-and-becker-muscular-dystrophy_en.pdf"},
    {"id":"7006","name":"Presentation - HCPWP observers for PCWP, ENCePP and Enpr-EMA (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hcpwp-observers-pcwp-encepp-and-enpr-ema-ivana-silva_en.pdf"},
    {"id":"7010","name":"Clodronic acid : List of nationally authorised medicinal products - PSUSA-00000804-201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T11:30:00Z","last_updated_date":"2017-10-31T11:32:13Z","reference_number":"EMA/663554/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/clodronic-acid-list-nationally-authorised-medicinal-products-psusa-00000804-201702_en.pdf"},
    {"id":"7011","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2012","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-07-01T12:15:00Z","last_updated_date":"2014-07-01T12:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2012_en.pdf"},
    {"id":"7012","name":"Acetylcysteine: List of nationally authorised medicinal products - PSUSA/00000034/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-17T16:43:25Z","reference_number":"EMA/344225/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetylcysteine-list-nationally-authorised-medicinal-products-psusa00000034201509_en.pdf"},
    {"id":"7013","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Tissue like combination of osteogenic cells and demineralised bone matrix (three-dimensional structure of demineralised bone matrix and ...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T13:30:00Z","last_updated_date":"2013-03-08T13:30:00Z","reference_number":"EMA/90882/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-tissue-combination-osteogenic-cells-and-demineralised-bone-matrix-three-dimensional-structure-demineralised-bone-matrix-and_en.pdf"},
    {"id":"7014","name":"EU/3/18/2040: Public summary of opinion on orphan designation: Recombinant human placental growth factor for the treatment of pre eclampsia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-22T12:02:00Z","last_updated_date":"2018-08-22T12:02:00Z","reference_number":"EMA/396455/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182040-public-summary-opinion-orphan-designation-recombinant-human-placental-growth-factor-treatment-pre-eclampsia_en.pdf"},
    {"id":"7016","name":"European Medicines Agency gives recommendations on the use of intravenous nicardipine","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-12T13:00:00Z","last_updated_date":"2014-03-12T13:00:00Z","reference_number":"EMA/14811/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_sv.pdf"}},
    {"id":"7018","name":"CHMP summary of positive opinion for Kalydeco","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/CHMP/311973/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kalydeco_en.pdf"},
    {"id":"7019","name":"European Medicines Agency gives first positive opinions on medicinal products for use outside the European Union","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"EMEA/382477/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-first-positive-opinions-medicinal-products-use-outside-european-union_en.pdf"},
    {"id":"7022","name":"Presentation - EMA Scientific Advice SME (Rory Breathnach)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-scientific-advice-sme-rory-breathnach_en.pdf"},
    {"id":"7023","name":"Questions and answers on the withdrawal of the marketing authorisation application for Zemfirza (cediranib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T14:00:00Z","last_updated_date":"2016-10-14T14:00:00Z","reference_number":"EMA/656265/2016","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zemfirza-cediranib_sv.pdf"}},
    {"id":"7024","name":"Guideline on active substance master file procedure - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-07-13T13:00:00Z","last_updated_date":"2013-06-10T12:54:00Z","reference_number":"CHMP/QWP/227/02 Rev.3 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-active-substance-master-file-procedure-revision-3_en.pdf"},
    {"id":"7025","name":"Draft list of references for assessment of Rhei radix Rheum palmatum L. and Rheum officinale Baillon (rhubarb)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2007-07-05T02:09:21Z","reference_number":"EMEA/HMPC/189625/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-rhei-radix-rheum-palmatum-l-and-rheum-officinale-baillon-rhubarb_en.pdf"},
    {"id":"7030","name":"CHMP post-authorisation summary of positive opinion for Xiliarx","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-12-16T01:00:00Z","last_updated_date":"2011-12-16T01:00:00Z","reference_number":"EMA/CHMP/975250/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xiliarx_en.pdf"},
    {"id":"7036","name":"Guidelines and concept papers adopted during the CHMP meeting 16-19 April 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T17:30:00Z","last_updated_date":"2012-04-20T17:30:00Z","reference_number":"EMA/CHMP/213033/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-16-19-april-2012_en.pdf"},
    {"id":"7037","name":"Report from experience acquired from pilot phase participation of patients / consumers representatives in the Pharmacovigilance Working Party (PhVWP) and proposal for participation of patients’ / consumers’ representativ...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-12-10T00:09:21Z","last_updated_date":"2009-12-10T00:09:21Z","reference_number":"EMA/355206/2009","document_url":"https://www.ema.europa.eu/en/documents/report/report-experience-acquired-pilot-phase-participation-patients-consumers-representatives-pharmacovigilance-working-party-phvwp-and-proposal-participation-patients-consumers-representativ_en.pdf"},
    {"id":"7038","name":"Committee on herbal medicinal products (HMPC): Meeting report, 14-15 January 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-02-05T00:00:00Z","last_updated_date":"2009-02-05T00:00:00Z","reference_number":"EMEA/HMPC/44177/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-14-15-january-2009_en.pdf"},
    {"id":"7040","name":"Agenda - Workshop on identifying opportunities for 'big data' in medicines development and regulatory science","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-11-08T10:30:00Z","last_updated_date":"2016-11-08T10:30:00Z","reference_number":"EMA/707605/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-identifying-opportunities-big-data-medicines-development-and-regulatory-science_en.pdf"},
    {"id":"7041","name":"Opinion following an Article 34 referral for Doxycycline 50% WSP and associated names: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-08-23T02:00:00Z","last_updated_date":"2011-08-23T02:00:00Z","reference_number":"EMA/507899/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-34-referral-doxycycline-50-wsp-and-associated-names-background-information_sv.pdf"}},
    {"id":"7043","name":"Vascace Plus - Article 30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-10-27T02:00:00Z","last_updated_date":"2011-11-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/vascace-plus-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/vascace-plus-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/vascace-plus-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/vascace-plus-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/vascace-plus-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/vascace-plus-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/vascace-plus-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/vascace-plus-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/vascace-plus-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/vascace-plus-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/vascace-plus-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/vascace-plus-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/vascace-plus-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/vascace-plus-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/vascace-plus-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/vascace-plus-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/vascace-plus-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/vascace-plus-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/vascace-plus-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/vascace-plus-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/vascace-plus-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/vascace-plus-article-30-referral-annex-iii_sv.pdf"}},
    {"id":"7044","name":"Committee for medicinal products for veterinary use: Meeting of 7 to 9 December 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-12-10T12:29:21Z","last_updated_date":"2004-12-10T12:29:21Z","reference_number":"EMEA/CVMP/1163/04-corrigendum","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-7-9-december-2004_en.pdf"},
    {"id":"7046","name":"News bulletin for small and medium-sized enterprises - Issue 25","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2013-10-08T16:58:00Z","last_updated_date":"2013-10-08T16:58:00Z","reference_number":"Issue 25","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-25_en.pdf"},
    {"id":"7047","name":"PDCO monthly report of opinions on paediatric investigation plans: 7-9 March 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-03-15T16:38:00Z","last_updated_date":"2012-03-15T16:38:00Z","reference_number":"EMA/PDCO/162635/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-7-9-march-2012_en.pdf"},
    {"id":"7048","name":"Committee for Proprietary Medicinal Products (CPMP) 64th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-10-23T02:00:00Z","last_updated_date":"2000-10-23T02:00:00Z","reference_number":"CPMP/2849/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-64th-plenary-meeting_en.pdf"},
    {"id":"7049","name":"Withdrawal assessment report for Opaxio","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-12-04T01:00:00Z","last_updated_date":"2009-12-04T01:00:00Z","reference_number":"EMA/CHMP/731026/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-opaxio_en.pdf"},
    {"id":"7050","name":"Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-08-13T15:00:00Z","last_updated_date":"2018-08-13T15:00:00Z","reference_number":"EMA/CHMP/BPWP/144533/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-viii-products-revision-2_en.pdf"},
    {"id":"7052","name":"Presentation - Feasibility and effectiveness of interventions: the valproate case study- EAN-ILAE joint task force (Marianne de Visser)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feasibility-and-effectiveness-interventions-valproate-case-study-ean-ilae-joint-task-force-marianne-de-visser_en.pdf"},
    {"id":"7053","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - November 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-12-06T14:25:00Z","last_updated_date":"2011-12-06T14:25:00Z","reference_number":"EMA/CVMP/899128/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-november-2011_en.pdf"},
    {"id":"7054","name":"Assessment of the paediatric needs - Migraine","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-06-02T02:00:00Z","last_updated_date":"2006-06-02T02:00:00Z","reference_number":"EMEA/224515/2006","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-migraine_en.pdf"},
    {"id":"7058","name":"Fusafungine Article-31 referral - PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-09-11T02:00:00Z","last_updated_date":"2015-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"7059","name":"Guidelines and concept papers adopted during the CHMP meeting 14-17 January 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-25T15:56:00Z","last_updated_date":"2013-01-25T15:56:00Z","reference_number":"EMA/28116/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-14-17-january-2013_en.pdf"},
    {"id":"7060","name":"Overview of comments received on draft guideline on injection site residues (EMEA/CVMP/542/03-FINAL)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-01-13T01:00:00Z","last_updated_date":"2005-01-13T01:00:00Z","reference_number":"EMEA/CVMP/209865/2004","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-injection-site-residues-emeacvmp54203-final_en.pdf"},
    {"id":"7062","name":"Human plasma (pooled and treated for virus inactivation) : List of nationally authorised medicinal products - PSUSA/00001635/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-30T17:04:00Z","last_updated_date":"2017-10-30T17:06:43Z","reference_number":"EMA/722339/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-plasma-pooled-and-treated-virus-inactivation-list-nationally-authorised-medicinal-products-psusa00001635201702_en.pdf"},
    {"id":"7063","name":"Presentation - An ongoing adaptive phase II/III trial with dose selection: A pragmatic solution for a development programme","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ongoing-adaptive-phase-iiiii-trial-dose-selection-pragmatic-solution-development-programme_en.pdf"},
    {"id":"7065","name":"CHMP summary of opinion for Zonisamide Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-01-29T01:00:00Z","reference_number":"EMA/CHMP/15884/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-zonisamide-mylan_en.pdf"},
    {"id":"7067","name":"Draft assessment report on Cynara scolymus L., folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-01-18T01:00:00Z","last_updated_date":"2011-01-18T01:00:00Z","reference_number":"EMA/HMPC/150209/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-cynara-scolymus-l-folium_en.pdf"},
    {"id":"7068","name":"Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T15:00:00Z","last_updated_date":"2018-09-18T17:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/non-imposed-post-authorisation-safety-study-pass-final-results-assessment-report-sub-template-type-ii-variations_en.docx"},
    {"id":"7069","name":"CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T18:00:00Z","last_updated_date":"2014-04-25T18:00:00Z","reference_number":"EMA/240581/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/cmdh-endorses-new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_en.pdf"},
    {"id":"7071","name":"EU/3/15/1604: Public summary of opinion on orphan designation: Two allogeneic irradiated pancreatic tumour cell lines for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T01:00:00Z","reference_number":"EMA/COMP/847393/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151604-public-summary-opinion-orphan-designation-two-allogeneic-irradiated-pancreatic-tumour-cell-lines-treatment-pancreatic-cancer_en.pdf"},
    {"id":"7075","name":"List of participants - EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations - December 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T13:30:00Z","last_updated_date":"2014-02-07T13:30:00Z","reference_number":"EMA/678769/2013","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations-december-2013_en.pdf"},
    {"id":"7076","name":"Presentation - New pharmacovigilance legislation: Questions and answers on practical transitional measures","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-pharmacovigilance-legislation-questions-and-answers-practical-transitional-measures_en.pdf"},
    {"id":"7077","name":"Guideline on the chemistry of new active substances (CVMP)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-05-01T02:00:00Z","last_updated_date":"2004-05-01T02:00:00Z","reference_number":"EMEA/CVMP/541/03/Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-chemistry-new-active-substances-cvmp_en.pdf"},
    {"id":"7080","name":"Presentation - An overview of EMA initiatives supporting SMEs - European Medicines Agency veterinary medicines innovation day (Helene Casaert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-ema-initiatives-supporting-smes-european-medicines-agency-veterinary-medicines-innovation-day-helene-casaert_en.pdf"},
    {"id":"7081","name":"Benefit-risk methodology project: Reply to the comments received from Dr William Holden on the work package 2 report","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-09T17:04:05Z","last_updated_date":"2011-06-09T17:04:05Z","reference_number":"EMA/61755/2011","document_url":"https://www.ema.europa.eu/en/documents/other/benefit-risk-methodology-project-reply-comments-received-dr-william-holden-work-package-2-report_en.pdf"},
    {"id":"7086","name":"Tick-borne encephalitis vaccine (inactivated) : List of nationally authorised medicinal products - PSUSA/00002951/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-04T11:38:00Z","last_updated_date":"2017-10-04T11:39:35Z","reference_number":"EMA/653963/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tick-borne-encephalitis-vaccine-inactivated-list-nationally-authorised-medicinal-products-psusa00002951201701_en.pdf"},
    {"id":"7087","name":"Presentation - How and Where to Control, Karin Sewerin, representing EBE","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T02:00:00Z","last_updated_date":"2011-10-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-and-where-control-karin-sewerin-representing-ebe_en.pdf"},
    {"id":"7088","name":"Guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-11-17T01:00:00Z","last_updated_date":"2008-11-17T01:00:00Z","reference_number":"EMEA/CVMP/IWP/220193/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-authorisation-under-exceptional-circumstances-vaccines-emergency-use-against-bluetongue_en.pdf"},
    {"id":"7090","name":"Presentation - General framework on managing uncertainties (Kevin Blake)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-framework-managing-uncertainties-kevin-blake_en.pdf"},
    {"id":"7092","name":"ICMRA - Mapping of supply chain/anticounterfeiting initiatives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-01-09T13:20:00Z","last_updated_date":"2017-01-09T13:20:00Z","reference_number":"EMA/104288/2015","document_url":"https://www.ema.europa.eu/en/documents/other/icmra-mapping-supply-chainanticounterfeiting-initiatives_en.pdf"},
    {"id":"7093","name":"Presentation - Formulations, packaging and medication practice considerations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-formulations-packaging-and-medication-practice-considerations_en.pdf"},
    {"id":"7094","name":"Presentation - Scientific advice/protocol assistance and patients (Francesca Cerreta)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-21T01:00:00Z","last_updated_date":"2015-01-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-adviceprotocol-assistance-and-patients-francesca-cerreta_en.pdf"},
    {"id":"7097","name":"EU/3/09/717: Public summary of opinion on orphan designation of ecopipam for the treatment of Lesch-Nyhan disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2010-03-03T01:00:00Z","reference_number":"EU/3/09/717","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309717-public-summary-opinion-orphan-designation-ecopipam-treatment-lesch-nyhan-disease_en.pdf"},
    {"id":"7098","name":"Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2011","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"EMA/INS/GCP/711390/2010","document_url":"https://www.ema.europa.eu/en/documents/other/workplan-good-clinical-practice-inspectors-working-group-gcp-iwg-2011_en.pdf"},
    {"id":"7099","name":"Public statement on Repso: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-07-28T12:42:00Z","last_updated_date":"2017-07-28T12:42:00Z","reference_number":"EMA/477146/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-repso-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"7100","name":"EU/3/13/1151: Public summary of opinion on orphan designation: Belinostat for the treatment of malignant thymoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2014-02-07T13:30:00Z","reference_number":"EMA/COMP/411546/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131151-public-summary-opinion-orphan-designation-belinostat-treatment-malignant-thymoma_en.pdf"},
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    {"id":"7105","name":"EU/3/12/1055: Public summary of opinion on orphan designation: Belinostat for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic / disseminated)","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2012-11-16T01:00:00Z","reference_number":"EMA/COMP/613019/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121055-public-summary-opinion-orphan-designation-belinostat-treatment-peripheral-t-cell-lymphoma-nodal-other-extranodal-and-leukaemic-disseminated_en.pdf"},
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    {"id":"7119","name":"EU/3/15/1451: Public summary of positive opinion for orphan designation of 5'-ASCSASTSCSASGSTSCSTSGSASUSASASGSCSTSA-3' for the treatment of alport syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2023-06-05T02:00:00Z","reference_number":"EMA/COMP/127039/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151451-public-summary-positive-opinion-orphan-designation-5-ascsastscsasgstscstsgsasusasasgscstsa-3-treatment-alport-syndrome_en.pdf"},
    {"id":"7121","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n21-24 May 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-05-25T02:09:21Z","last_updated_date":"2007-05-25T02:09:21Z","reference_number":"EMEA/231382/2007 - corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-21-24-may-2007_en.pdf"},
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    {"id":"7132","name":"Axxonis Pharma AG withdraws its marketing authorisation application for Nenad (lisuride)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-03T00:09:21Z","last_updated_date":"2009-12-03T00:09:21Z","reference_number":"EMEA/775140/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/axxonis-pharma-ag-withdraws-its-marketing-authorisation-application-nenad-lisuride_en.pdf"},
    {"id":"7133","name":"Declaration of interests - Nicolino Ruperto","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-nicolino-ruperto_en.pdf"},
    {"id":"7136","name":"Furosemide Vitabalans Article-29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-07-30T17:30:00Z","last_updated_date":"2013-07-30T17:30:00Z","reference_number":"EMA/254361/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/furosemide-vitabalans-article-294-referral-assessment-report_en.pdf"},
    {"id":"7138","name":"EU/3/04/187: Public summary of positive opinion for orphan designation of human monoclonal hepatitis B immunoglobulins for the prevention of hepatitis B re-infection following liver transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-07-10T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/29/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304187-public-summary-positive-opinion-orphan-designation-human-monoclonal-hepatitis-b-immunoglobulins-prevention-hepatitis-b-re-infection-following-liver-transplantation_en.pdf"},
    {"id":"7140","name":"Ipratropium: List of nationally authorised medicinal products - PSUSA/00001780/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-06T13:51:00Z","last_updated_date":"2017-10-06T14:14:33Z","reference_number":"EMA/662326/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ipratropium-list-nationally-authorised-medicinal-products-psusa00001780201701_en.pdf"},
    {"id":"7144","name":"EU/3/03/165: Public summary of positive opinion for orphan designation of \n\nnolatrexed for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-23T00:00:00Z","last_updated_date":"2007-02-23T00:00:00Z","reference_number":"EMEA/COMP/1384/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303165-public-summary-positive-opinion-orphan-designation-nolatrexed-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"7145","name":"European Medicines Agency recommends revaccination for some travellers in need of protection with Ixiaro","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/CHMP/401327/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-revaccination-some-travellers-need-protection-ixiaro_en.pdf"},
    {"id":"7147","name":"EU/3/13/1152: Public summary of opinion on orphan designation: (1-Methyl-2-nitro-1H-imidazole-5-yl)methyl N,N’-bis(2-bromoethyl)diamidophosphate for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-16T13:00:00Z","last_updated_date":"2017-10-19T13:00:00Z","reference_number":"EMA/COMP/402338/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131152-public-summary-opinion-orphan-designation-1-methyl-2-nitro-1h-imidazole-5-ylmethyl-nn-bis2-bromoethyldiamidophosphate-treatment-pancreatic-cancer_en.pdf"},
    {"id":"7153","name":"Union recommendations on the training and experience of inspectors performing pharmacovigilance inspections","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-06-20T12:15:00Z","last_updated_date":"2014-06-20T12:15:00Z","reference_number":"EMA/INS/PhV/192237/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/union-recommendations-training-and-experience-inspectors-performing-pharmacovigilance-inspections_en.pdf"},
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    {"id":"7156","name":"EU/3/11/864: Public summary of opinion on orphan designation: Adeno-associated viral vector containing the human ARSB gene for the treatment of mucopolysaccharidosis VI (Maroteaux-Lamy syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/COMP/158082/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311864-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-arsb-gene-treatment-mucopolysaccharidosis-vi-maroteaux-lamy-syndrome_en.pdf"},
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    {"id":"7164","name":"EU/3/01/034: Public summary of positive opinion for orphan designation of gusperimus trihydrochloride for the treatment of Wegener’s granulomatosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-03T00:00:00Z","last_updated_date":"2011-11-19T00:00:00Z","reference_number":"EMEA/COMP/169/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301034-public-summary-positive-opinion-orphan-designation-gusperimus-trihydrochloride-treatment-wegeners-granulomatosis_en.pdf"},
    {"id":"7165","name":"Presentation - Clinical trials – experience of the pediatric IBD Porto group","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-22T01:00:00Z","last_updated_date":"2011-03-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-experience-pediatric-ibd-porto-group_en.pdf"},
    {"id":"7166","name":"CHMP post-authorisation summary of positive opinion for Adenuric","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/CHMP/79455/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adenuric_en.pdf"},
    {"id":"7168","name":"Presentation - 1.3 InSPiRe: innovative methodology for small-populations research -  An overview of research (Nigel Stallard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-13-inspire-innovative-methodology-small-populations-research-overview-research-nigel-stallard_en.pdf"},
    {"id":"7169","name":"Committee for Proprietary Medicinal Products (CPMP) 31st plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-10-24T02:00:00Z","last_updated_date":"1997-10-24T02:00:00Z","reference_number":"CPMP/921/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-31st-plenary-meeting_en.pdf"},
    {"id":"7171","name":"Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-01-24T01:00:00Z","reference_number":"EMA/33514/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/withdrawal-marketing-authorisation-application-winfuran-nalfurafine_sv.pdf"}},
    {"id":"7173","name":"Superseded final Community herbal monograph on Mentha x piperita L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2007-07-05T02:00:00Z","reference_number":"EMEA/HMPC/193909/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-mentha-x-piperita-l-folium_en.pdf"},
    {"id":"7176","name":"EMA to further clarify safety profile of human papillomavirus (HPV) vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-07-13T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMA/454979/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-further-clarify-safety-profile-human-papillomavirus-hpv-vaccines_en.pdf"},
    {"id":"7180","name":"Colistin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-07-23T02:00:00Z","last_updated_date":"2002-07-23T02:00:00Z","reference_number":"EMEA/MRL/016/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/colistin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7182","name":"Draft list of references supporting the assessment of Phaseolus vulgaris L., fructus sine semine","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-05-14T02:00:00Z","last_updated_date":"2013-05-14T02:00:00Z","reference_number":"EMA/HMPC/317318/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-phaseolus-vulgaris-l-fructus-sine-semine_en.pdf"},
    {"id":"7186","name":"Oxibendazole: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-10-01T02:00:00Z","last_updated_date":"1997-10-01T02:00:00Z","reference_number":"EMEA/MRL/268/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxibendazole-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7187","name":"Presentation - EMA/EGA workshop - Session 4: Line Extension of Immediate Release Products (Andrzej Dzierbicki)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-4-line-extension-immediate-release-products-andrzej-dzierbicki_en.pdf"},
    {"id":"7188","name":"Work plan for the Cardiovascular Working Party 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2018-01-05T17:00:00Z","last_updated_date":"2018-01-08T17:00:00Z","reference_number":"EMA/CHMP/365586/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-cardiovascular-working-party-2018_en.pdf"},
    {"id":"7189","name":"COMP meeting report on the review of applications for orphan designation: February 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-02-13T11:00:00Z","last_updated_date":"2013-02-13T11:00:00Z","reference_number":"EMA/COMP/63660/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-february-2013_en.pdf"},
    {"id":"7190","name":"Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring addressed to member states for Ledipasvir/Sofosbuvir available for compassionate use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-02T13:00:00Z","last_updated_date":"2020-10-26T10:06:00Z","reference_number":"EMA/181959/2014","document_url":"https://www.ema.europa.eu/en/documents/other/conditions-use-conditions-distribution-and-patients-targeted-and-conditions-safety-monitoring-addressed-member-states-ledipasvirsofosbuvir-available-compassionate-use_en.pdf"},
    {"id":"7191","name":"Presentation - Patient, consumer and health care provider involvement in EUnetHTA JA3 - EMA's PCWP and HCPWP joint meeting (Rosa Anne Willemsen,Chantal Guilhaume)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-consumer-and-health-care-provider-involvement-eunethta-ja3-emas-pcwp-and-hcpwp-joint-meeting-rosa-anne-willemsenchantal-guilhaume_en.pdf"},
    {"id":"7195","name":"European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2012-11-16T01:00:00Z","reference_number":"EMA/CHMP/734886/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-new-advice-surgeons-safer-use-fibrin-sealants-evicel-and-quixil_en.pdf"},
    {"id":"7198","name":"Questions and answers relating to PQQ","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-01T01:00:00Z","last_updated_date":"2008-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-pqq_en.pdf"},
    {"id":"7199","name":"Note for guidance on the risk analysis approach for residues of veterinary medicinal products in food of animal origin","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-01-01T01:00:00Z","last_updated_date":"2001-01-01T01:00:00Z","reference_number":"EMEA/CVMP/187/00 - FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-risk-analysis-approach-residues-veterinary-medicinal-products-food-animal-origin_en.pdf"},
    {"id":"7200","name":"Presentation - Estimating the probability of target attainment (George Drusano)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-estimating-probability-target-attainment-george-drusano_en.pdf"},
    {"id":"7201","name":"EU/3/11/857: Public summary of positive opinion for orphan designation:  Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA for the treatment of transthyretin-mediated amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/82557/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311857-public-summary-positive-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-transthyretin-mrna-treatment-transthyretin-mediated-amyloidosis_en.pdf"},
    {"id":"7202","name":"Presentation - State Institute for Drug Control (SàšKL): Highlights from recent scientific advice and protocol assistance on quality issues (Blanka Hirschlerovà¡)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-state-institute-drug-control-saskl-highlights-recent-scientific-advice-and-protocol-assistance-quality-issues-blanka-hirschlerova_en.pdf"},
    {"id":"7204","name":"Questions and answers on the suspension of medicines containing sibutramine","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-01-21T01:00:00Z","last_updated_date":"2010-09-15T02:00:00Z","reference_number":"EMA/808179/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-suspension-medicines-containing-sibutramine_sv.pdf"}},
    {"id":"7205","name":"Draft assessment report on Salvia officinalis L., folium and Salvia officinalis L., aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-02-15T12:00:00Z","last_updated_date":"2016-02-15T12:00:00Z","reference_number":"EMA/HMPC/150801/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-salvia-officinalis-l-folium-and-salvia-officinalis-l-aetheroleum_en.pdf"},
    {"id":"7207","name":"European Medicines Agency recommends transfer of manufacturing sites for Caelyx and Ceplene","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T11:00:00Z","last_updated_date":"2012-03-16T11:00:00Z","reference_number":"EMA/CHMP/185096/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-transfer-manufacturing-sites-caelyx-and-ceplene_en.pdf"},
    {"id":"7209","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow-derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T16:40:00Z","last_updated_date":"2018-06-27T16:40:00Z","reference_number":"EMA/276857/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"7211","name":"Position paper on the maximum in-use shelf-life for medicated drinking water","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-12-01T01:00:00Z","last_updated_date":"2002-12-01T01:00:00Z","reference_number":"EMEA/CVMP/1090/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-maximum-use-shelf-life-medicated-drinking-water_en.pdf"},
    {"id":"7214","name":"Protelos and Osseor Article-20 procedure: PRAC List of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T14:00:00Z","last_updated_date":"2013-05-17T14:00:00Z","reference_number":"EMA/PRAC/283429/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/protelos-and-osseor-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"7216","name":"Working party on Herbal Medicinal Products:  Comments on the Commission Regulation (EC) No. 541/95 of 10 March 1995 concerning the examination of variations to the terms of a marketing authorisation granted by a competen...","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/HMPWP/20/99","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-comments-commission-regulation-ec-no-54195-10-march-1995-concerning-examination-variations-terms-marketing-authorisation-granted-competen_en.pdf"},
    {"id":"7217","name":"Presentation - New European Union pharmacovigilance legislation: Early industry experience, challenges for implementation and some proposals (Laurent Auclert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-european-union-pharmacovigilance-legislation-early-industry-experience-challenges-implementation-and-some-proposals-laurent-auclert_en.pdf"},
    {"id":"7219","name":"Technical Specifications – Annex IX Template for completing the test: Procurement procedure EMA/2014/01/PH","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-ix-template-completing-test-procurement-procedure-ema201401ph_en.xls"},
    {"id":"7220","name":"Presentation - Operational preparedness for Brexit and re-allocation of United Kingdom product portfolio in the centralised procedure","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T02:00:00Z","last_updated_date":"2018-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-operational-preparedness-brexit-and-re-allocation-united-kingdom-product-portfolio-centralised-procedure_en.pdf"},
    {"id":"7226","name":"Candesartan, candesartan / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000527/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-06T13:10:00Z","last_updated_date":"2018-03-06T13:39:18Z","reference_number":"EMA/415684/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/candesartan-candesartan-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00000527201704_en.pdf"},
    {"id":"7228","name":"Evaluation guide for good-manufacturing-practice regulatory compliance programme: Audit checklist","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-12-21T01:00:00Z","last_updated_date":"2023-03-14T08:45:00Z","reference_number":"EMA/INS/GMP/119415/2023","document_url":"https://www.ema.europa.eu/en/documents/other/evaluation-guide-good-manufacturing-practice-regulatory-compliance-programme-audit-checklist_en.pdf"},
    {"id":"7229","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/COMP/11127/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-esbriet-pirfenidone-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"7233","name":"EU/3/06/406: Public summary of positive opinion for orphan designation of arimoclomol for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2022-07-19T11:29:00Z","reference_number":"EMA/COMP/225724/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306406-public-summary-positive-opinion-orphan-designation-arimoclomol-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"7236","name":"EU/3/18/2014: Public summary of opinion on orphan designation: 1-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4-c]pyridin-6-yl)ethan-1-one for the treatment of Stargardt'...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T18:30:00Z","last_updated_date":"2018-07-23T18:30:00Z","reference_number":"EMA/270132/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182014-public-summary-opinion-orphan-designation-1-3-4-34-difluoro-2-trifluoromethylphenylpiperidine-1-carbonyl-1h4h5h6h7h-pyrazolo34-cpyridin-6-ylethan-1-one-treatment-stargardt_en.pdf"},
    {"id":"7240","name":"Committee for Medicinal Products for Human Use (CHMP) - March 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-04-01T02:00:00Z","last_updated_date":"2005-04-01T02:00:00Z","reference_number":"EMEA/CHMP/82984/2005 corr 2","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-march-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"7242","name":"Public hearing on quinolones and fluoroquinolones: 23 speakers from 11 EU countries to share experience","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/378251/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/public-hearing-quinolones-and-fluoroquinolones-23-speakers-11-eu-countries-share-experience_en.pdf"},
    {"id":"7245","name":"Presentation - Feedback to the draft guideline on qualification and reporting of PBPK modelling and simulation (N. Parrott)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-draft-guideline-qualification-and-reporting-pbpk-modelling-and-simulation-n-parrott_en.pdf"},
    {"id":"7246","name":"Propane, n-butane, isobutane: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/031/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/propane-n-butane-isobutane-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7247","name":"Speakers biographies - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimicrobial ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/478295/2017","document_url":"https://www.ema.europa.eu/en/documents/other/speakers-biographies-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-info-session-antimicrobial_en.pdf"},
    {"id":"7248","name":"Presentation - Supply shortages of medicines (Franà§ois Houà¿ez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T17:00:00Z","last_updated_date":"2013-07-18T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supply-shortages-medicines-franassois-houaez_en.pdf"},
    {"id":"7249","name":"Final assessment report on Solanum dulcamara L., stipites","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2013-02-15T01:00:00Z","reference_number":"EMA/HMPC/734363/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-solanum-dulcamara-l-stipites_en.pdf"},
    {"id":"7252","name":"Guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-12-14T01:00:00Z","last_updated_date":"2006-12-14T01:00:00Z","reference_number":"CHMP/EWP/438/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-psoriatic-arthritis_en.pdf"},
    {"id":"7255","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 21-22 November 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-12-09T15:55:00Z","last_updated_date":"2011-12-09T15:55:00Z","reference_number":"EMA/HMPC/932075/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-21-22-november-2011_en.pdf"},
    {"id":"7257","name":"Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-11-01T01:00:00Z","reference_number":"EMA/CHMP/158542/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/asenapine-sublingual-tablets-5-and-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"7260","name":"Review of Corlentor/Procoralan started","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T02:00:00Z","last_updated_date":"2014-05-08T02:00:00Z","reference_number":"EMA/280865/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-corlentorprocoralan-started_en.pdf"},
    {"id":"7261","name":"Draft community herbal monograph on Hamamelis virginiana L., folium et cortex destillatum and Hamamelis virginiana L., ramunculus destillatium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/114584/2008 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-hamamelis-virginiana-l-folium-et-cortex-destillatum-and-hamamelis-virginiana-l-ramunculus-destillatium_en.pdf"},
    {"id":"7262","name":"Amlodipine besilate / ramipril: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation  - PSUSA/00000181/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-10-17T19:40:07Z","reference_number":"EMA/85620/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-besilate-ramipril-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000181201503_en.pdf"},
    {"id":"7263","name":"Scientific Recommendation on the Classification of ATMPs - Marie-Helene Pinheiro","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-recommendation-classification-atmps-marie-helene-pinheiro_en.pdf"},
    {"id":"7264","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 13-16 December 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-01-19T10:30:00Z","last_updated_date":"2017-01-19T10:30:00Z","reference_number":"EMA/PDCO/853813/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-13-16-december-2016_en.pdf"},
    {"id":"7265","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2013 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-07-04T12:05:00Z","last_updated_date":"2013-07-04T12:05:00Z","reference_number":"EMA/CAT/323934/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-june-2013-meeting_en.pdf"},
    {"id":"7266","name":"Explanatory note: EudraVigilance access policy for medicines for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-08T17:50:18Z","last_updated_date":"2011-07-08T17:50:18Z","reference_number":"EMA/529383/2011","document_url":"https://www.ema.europa.eu/en/documents/other/explanatory-note-eudravigilance-access-policy-medicines-human-use_en.pdf"},
    {"id":"7269","name":"Milrinone: List of nationally authorised medicinal products - PSUSA/00002064/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-15T02:00:00Z","last_updated_date":"2016-10-18T12:21:23Z","reference_number":"EMA/418285/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/milrinone-list-nationally-authorised-medicinal-products-psusa00002064201510_en.pdf"},
    {"id":"7270","name":"EU/3/07/477: Public summary of positive opinion for orphan designation of 4-Amino-1-[5-O-[(2R,4S)-2-oxido-4-(4-pyridinyl)-1,3,2-dioxaphosphorinan-2-yl]-β-D-arabinofuranosyl]-2(1H)-pyrimidinone for the treatment of hepat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-01-22T01:00:00Z","last_updated_date":"2008-01-22T01:00:00Z","reference_number":"EMEA/COMP/388117/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307477-public-summary-positive-opinion-orphan-designation-4-amino-1-5-o-2r4s-2-oxido-4-4-pyridinyl-132-dioxaphosphorinan-2-yl-i2-d-arabinofuranosyl-21h-pyrimidinone-treatment-hepat_en.pdf"},
    {"id":"7273","name":"Draft list of references supporting the assessment of Capsella bursa-pastoris (L.) Medikus, herba - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-01-18T01:00:00Z","last_updated_date":"2011-01-18T01:00:00Z","reference_number":"EMA/HMPC/369803/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-capsella-bursa-pastoris-l-medikus-herba-first-version_en.pdf"},
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    {"id":"7278","name":"CMDh endorses new advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T18:00:00Z","last_updated_date":"2014-04-25T18:00:00Z","reference_number":"EMA/240581/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/cmdh-endorses-new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_en.pdf"},
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    {"id":"7288","name":"EU/3/16/1660: Public summary of opinion on orphan designation: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene for the treatment of beta thalassaemia intermedia and major","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"EMA/COMP/309791/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161660-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-encoding-human-beta-globin-gene-treatment-beta-thalassaemia-intermedia-and-major_en.pdf"},
    {"id":"7289","name":"Presentation - Update from SME Office (Constantinos Ziogas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-sme-office-constantinos-ziogas_en.pdf"},
    {"id":"7292","name":"Paliperidone palmitate depot suspension for injection 25 mg, 50 mg, 75 mg, 100 mg and 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-03T01:00:00Z","last_updated_date":"2017-03-03T01:00:00Z","reference_number":"EMA/CHMP/474825/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paliperidone-palmitate-depot-suspension-injection-25-mg-50-mg-75-mg-100-mg-and-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
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    {"id":"7295","name":"Small and medium-sized enterprise (SME) Office annual report 2013","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2014-01-30T15:45:00Z","last_updated_date":"2014-01-30T15:45:00Z","reference_number":"EMA/716205/2013","document_url":"https://www.ema.europa.eu/en/documents/annual-report/small-and-medium-sized-enterprise-sme-office-annual-report-2013_en.pdf"},
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    {"id":"7298","name":"Questions and answers on Haldol and associated names (haloperidol tablets, oral solutions and injectable solution)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T13:00:00Z","last_updated_date":"2017-05-05T19:00:00Z","reference_number":"EMA/122476/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-haldol-and-associated-names-haloperidol-tablets-oral-solutions-and-injectable-solution_sv.pdf"}},
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    {"id":"7303","name":"Goserelin Cell Pharm - Article 36 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/goserelin-cell-pharm-article-36-referral-assessment-report_en.pdf"},
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    {"id":"7325","name":"Involvement of patients in PRAC benefit-risk (J. M. Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/involvement-patients-prac-benefit-risk-j-m-raine_en.pdf"},
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    {"id":"7330","name":"CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Initial text","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-initial-text_en.pdf"},
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    {"id":"7338","name":"30th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-03-12T12:39:21Z","last_updated_date":"1998-03-12T12:39:21Z","reference_number":"EMEA/CVMP/095/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/30th-meeting-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"7341","name":"Request for an opinion regarding the risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-12T19:30:00Z","last_updated_date":"2014-09-12T19:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/request-opinion-regarding-risks-vultures-and-other-necrophagous-bird-populations-union-connection-use-veterinary-medicinal-products-containing-substance-diclofenac_en.pdf"},
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    {"id":"7346","name":"European Medicines Agency recommends first medical treatment for removal of eschar from severe burn wounds","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-09-21T15:00:00Z","last_updated_date":"2012-09-21T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-first-medical-treatment-removal-eschar-severe-burn-wounds_en.pdf"},
    {"id":"7347","name":"European Medicines Agency 20th anniversary book","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2015-03-18T12:00:00Z","last_updated_date":"2015-03-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/european-medicines-agency-20th-anniversary-book_en.pdf"},
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    {"id":"7351","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 March 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-09T17:00:00Z","last_updated_date":"2012-03-09T17:00:00Z","reference_number":"EMA/CVMP/137028/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-march-2012_en.pdf"},
    {"id":"7353","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 22–25 April 2014","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2014-04-25T17:02:00Z","last_updated_date":"2014-04-25T17:02:00Z","reference_number":"EMA/247936/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-22-25-april-2014_en.pdf"},
    {"id":"7356","name":"Ipsen Ltd withdraws its application for an extension of indication for NutropinAq","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-01-28T00:09:21Z","last_updated_date":"2008-01-28T00:09:21Z","reference_number":"EMEA/45635/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/ipsen-ltd-withdraws-its-application-extension-indication-nutropinaq_en.pdf"},
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    {"id":"7362","name":"European Medicines Agency confirms positive benefit-risk balance of Protelos / Osseor, but recommends new contraindications and revised warnings","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T11:00:00Z","last_updated_date":"2012-03-16T11:00:00Z","reference_number":"EMA/CHMP/185175/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-confirms-positive-benefit-risk-balance-protelos-osseor-recommends-new-contraindications-and-revised-warnings_en.pdf"},
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    {"id":"7369","name":"EMEA recommends changes in the product information for Protelos/Osseor due to the risk of severe hypersensitivity reactions","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-16T00:09:21Z","last_updated_date":"2007-11-16T00:09:21Z","reference_number":"EMEA/417458/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-changes-product-information-protelososseor-due-risk-severe-hypersensitivity-reactions_en.pdf"},
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    {"id":"7384","name":"Hydroxyethyl starch Article-107i referral - Rationale for triggering","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-rationale-triggering_en.pdf"},
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    {"id":"7397","name":"Declaration of interests: Marisa Papaluca Amati","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:15Z","last_updated_date":"2014-06-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-marisa-papaluca-amati_en.pdf"},
    {"id":"7398","name":"Committee for Orphan Medicinal Products: April 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-04-12T02:00:00Z","last_updated_date":"2005-04-12T02:00:00Z","reference_number":"EMEA/COMP/127051/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-april-2005-meeting_en.pdf"},
    {"id":"7399","name":"Presentation - PD targets in non-clinical models: how much bacterial killing? (Michael Dudley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pd-targets-non-clinical-models-how-much-bacterial-killing-michael-dudley_en.pdf"},
    {"id":"7401","name":"Start of community reviews - CHMP meeting of 20-23 October 2014","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/388940/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-20-23-october-2014_en.pdf"},
    {"id":"7404","name":"Renitec - Article 30 referral - Summary of product characteristics","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-12-02T00:08:21Z","last_updated_date":"2003-12-02T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/renitec-article-30-referral-summary-product-characteristics_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/renitec-article-30-referral-summary-product-characteristics_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/renitec-article-30-referral-summary-product-characteristics_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/renitec-article-30-referral-summary-product-characteristics_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/renitec-article-30-referral-summary-product-characteristics_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/renitec-article-30-referral-summary-product-characteristics_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/renitec-article-30-referral-summary-product-characteristics_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/renitec-article-30-referral-summary-product-characteristics_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/renitec-article-30-referral-summary-product-characteristics_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/renitec-article-30-referral-summary-product-characteristics_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/renitec-article-30-referral-summary-product-characteristics_sv.pdf"}},
    {"id":"7405","name":"Presentation - FDA experience with measuring the impact of pharmacovigilance (Gerald Dal Pan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-experience-measuring-impact-pharmacovigilance-gerald-dal-pan_en.pdf"},
    {"id":"7406","name":"CVMP post-authorisation summary of positive opinion for Metacam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/CVMP/371866/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam_en.pdf-1"},
    {"id":"7409","name":"Presentation - Stakeholder interaction in EMA innovation support - European Medicines Agency veterinary medicines innovation day (Ivo Claassen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stakeholder-interaction-ema-innovation-support-european-medicines-agency-veterinary-medicines-innovation-day-ivo-claassen_en.pdf"},
    {"id":"7411","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-notification_en.pdf"},
    {"id":"7412","name":"Questions and answers following the initial experience of the adaptive-licensing pilot project","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-11T20:05:00Z","last_updated_date":"2014-09-11T20:05:00Z","reference_number":"EMA/417706/2014 ","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-following-initial-experience-adaptive-licensing-pilot-project_en.pdf"},
    {"id":"7414","name":"PDCO meeting highlights 16-18 January 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-01-25T00:00:00Z","last_updated_date":"2008-01-25T00:00:00Z","reference_number":"EMEA/PDCO/33961/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-16-18-january-2008_en.pdf"},
    {"id":"7417","name":"EU/3/16/1617: Public summary of opinion on orphan designation: Venetoclax for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/72835/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161617-public-summary-opinion-orphan-designation-venetoclax-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"7419","name":"Presentation - The New PV Legislation Perspective from a Member State","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-pv-legislation-perspective-member-state_en.pdf"},
    {"id":"7420","name":"Draft guideline on reporting the results of population pharmacokinetic analyses","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-06-29T02:00:00Z","last_updated_date":"2006-06-29T02:00:00Z","reference_number":"EMEA/CHMP/EWP/185990/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-reporting-results-population-pharmacokinetic-analyses_en.pdf"},
    {"id":"7421","name":"Committee for medicinal products for human use, summary of positive opinion for Synflorix","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/CHMP/13120/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-synflorix_en.pdf"},
    {"id":"7423","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting Session on communicatio...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-03-08T11:15:00Z","last_updated_date":"2016-07-05T12:15:00Z","reference_number":"EMA/856049/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-session_en.pdf"},
    {"id":"7424","name":"EMEA's provision of information to the EMEA's stakeholders - Brainstorming meeting - Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-04-18T02:09:21Z","last_updated_date":"2008-04-18T02:09:21Z","reference_number":"EMEA/436248/2007","document_url":"https://www.ema.europa.eu/en/documents/report/emeas-provision-information-emeas-stakeholders-brainstorming-meeting-report_en.pdf"},
    {"id":"7425","name":"Presentation - Environmental Risk Assessment Recent developments (Chris Van den Eede)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T02:00:00Z","last_updated_date":"2017-03-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-environmental-risk-assessment-recent-developments-chris-van-den-eede_en.pdf"},
    {"id":"7426","name":"IFAH-Europe views","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ifah-europe-views_en.pdf"},
    {"id":"7427","name":"Presentation - U.S. regulatory and economic incentives for antibiotic research and development (Amanda Jezek)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-us-regulatory-and-economic-incentives-antibiotic-research-and-development-amanda-jezek_en.pdf"},
    {"id":"7428","name":"CVMP post-authorisation summary of positive opinion for Zactran","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"EMA/CVMP/749682/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-zactran_en.pdf"},
    {"id":"7429","name":"Status of EMEA scientific guidelines and European pharmacopoeia monographs and chapters in the regulatory framework applicable to medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-09-11T02:00:00Z","last_updated_date":"2008-09-11T02:00:00Z","reference_number":"EMEA/42371/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/status-emea-scientific-guidelines-and-european-pharmacopoeia-monographs-and-chapters-regulatory-framework-applicable-medicinal-products_en.pdf"},
    {"id":"7430","name":"Programme - Transatlantic workshop: Drug-related progressive multifocal leukoencephalopathy (PML)","type":"other","status":"Draft","consultation_date":"","first_published_date":"2011-04-05T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"EMA/262331/2011","document_url":"https://www.ema.europa.eu/en/documents/other/programme-transatlantic-workshop-drug-related-progressive-multifocal-leukoencephalopathy-pml_en.pdf"},
    {"id":"7433","name":"Presentation - Topic 1 - Patients perspective: Eurordis- Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Virginie Hivert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-1-patients-perspective-eurordis-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-virginie-hivert_en.pdf"},
    {"id":"7434","name":"Presentation - ESVAC state of play (Jordi Torren Edo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T13:00:00Z","last_updated_date":"2015-04-20T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-esvac-state-play-jordi-torren-edo_en.pdf"},
    {"id":"7435","name":"Presentation - Paediatric Rheumatology InterNational Trials Organization (PRINTO) experience with trials in paediatric rheumatology","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-22T01:00:00Z","last_updated_date":"2011-03-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-rheumatology-international-trials-organization-printo-experience-trials-paediatric-rheumatology_en.pdf"},
    {"id":"7437","name":"Draft guideline on virus safety evaluation of biotechnological investigational medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-06-28T02:00:00Z","last_updated_date":"2006-06-28T02:00:00Z","reference_number":"EMEA/CHMP/BWP/398498/2005-corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-virus-safety-evaluation-biotechnological-investigational-medicinal-products_en.pdf"},
    {"id":"7439","name":"Naratriptan: List of nationally authorised medicinal products - PSUSA/00002126/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T16:04:00Z","last_updated_date":"2017-10-27T16:09:29Z","reference_number":"EMA/716726/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/naratriptan-list-nationally-authorised-medicinal-products-psusa00002126201702_en.pdf"},
    {"id":"7442","name":"European Medicines Agency adopts first positive opinion for a medicinal product derived from transgenic biotechnology","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-06-02T02:00:00Z","last_updated_date":"2006-06-02T02:00:00Z","reference_number":"EMEA/203163/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-adopts-first-positive-opinion-medicinal-product-derived-transgenic-biotechnology_en.pdf"},
    {"id":"7443","name":"A Regulation addressing the needs for drug development in rare diseases: Martin Terberger, Mirjam Sà¶derholm","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/regulation-addressing-needs-drug-development-rare-diseases-martin-terberger-mirjam-sapderholm_en.pdf"},
    {"id":"7444","name":"Public statement on Ipreziv: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-12-19T01:00:00Z","last_updated_date":"2014-12-19T01:00:00Z","reference_number":"EMA/710373/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ipreziv-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"7445","name":"Presentation - PRAC Work Plan 2018 (J.  Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prac-work-plan-2018-j-raine_en.pdf"},
    {"id":"7446","name":"CHMP summary of opinion for Sialanar","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/CHMP/487260/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-sialanar_en.pdf"},
    {"id":"7449","name":"Pathogen specific database: Smallpox","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-smallpox_en.pdf"},
    {"id":"7450","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-06-02T16:15:00Z","last_updated_date":"2014-06-02T16:15:00Z","reference_number":"EMA/CAT/312972/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-may-2014-meeting_en.pdf"},
    {"id":"7451","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-12T12:30:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/847158/2016","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf"},
    {"id":"7452","name":"Gadoteric acid (IV and intravascular formulations): List of nationally authorised medicinal products - PSUSA/00001506/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T01:00:00Z","last_updated_date":"2016-10-19T12:37:30Z","reference_number":"EMA/194278/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteric-acid-iv-and-intravascular-formulations-list-nationally-authorised-medicinal-products-psusa00001506201504_en.pdf"},
    {"id":"7453","name":"Request to assess the risk of occurrence of contamination with Mesilate Esters and related compounds in pharmaceuticals.","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T00:09:21Z","last_updated_date":"2008-01-24T00:09:21Z","reference_number":"EMEA/44714/2008","document_url":"https://www.ema.europa.eu/en/documents/other/request-assess-risk-occurrence-contamination-mesilate-esters-and-related-compounds-pharmaceuticals_en.pdf"},
    {"id":"7456","name":"Final assessment report on Agrimonia eupatoria L., herba - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T13:00:00Z","last_updated_date":"2015-04-09T13:00:00Z","reference_number":"EMA/HMPC/680595/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-agrimonia-eupatoria-l-herba-first-version_en.pdf"},
    {"id":"7457","name":"Flupirtine Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-05-04T02:00:00Z","last_updated_date":"2018-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flupirtine-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flupirtine-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flupirtine-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flupirtine-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flupirtine-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flupirtine-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flupirtine-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flupirtine-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/flupirtine-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flupirtine-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flupirtine-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flupirtine-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flupirtine-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flupirtine-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flupirtine-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flupirtine-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flupirtine-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flupirtine-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flupirtine-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flupirtine-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flupirtine-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flupirtine-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"7459","name":"EMEA/INFARMED/EXPERTISSUES joint workshop on cell based medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-05-25T02:09:21Z","last_updated_date":"2007-05-25T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/emeainfarmedexpertissues-joint-workshop-cell-based-medicinal-products_en.pdf"},
    {"id":"7461","name":"Committee for medicinal products for veterinary use - EMA public bulletin 2009 on veterinary pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-17T01:09:21Z","last_updated_date":"2010-02-17T01:09:21Z","reference_number":"EMA/CVMP/PhVWP/729768/2009","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-ema-public-bulletin-2009-veterinary-pharmacovigilance_en.pdf"},
    {"id":"7465","name":"Committee for Proprietary Medicinal Products (CPMP) 29th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-07-25T02:00:00Z","last_updated_date":"1997-07-25T02:00:00Z","reference_number":"CPMP/651/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-29th-plenary-meeting_en.pdf"},
    {"id":"7466","name":"CVMP summary of positive opinion for Equilis West Nile","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2013-04-12T19:00:00Z","last_updated_date":"2013-04-12T19:00:00Z","reference_number":"EMA/CVMP/161880/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-equilis-west-nile_en.pdf"},
    {"id":"7468","name":"Presentation - Lumpy skin disease situation in Bulgaria (Georgi Chobanov)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-08-07T16:09:00Z","last_updated_date":"2017-08-07T16:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lumpy-skin-disease-situation-bulgaria-georgi-chobanov_en.pdf"},
    {"id":"7469","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course 20-21 November 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-24T14:00:00Z","last_updated_date":"2014-09-24T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-training-course-20-21-november-2014_en.pdf"},
    {"id":"7470","name":"Presentation - FDA International, Europe (Colin McKiff)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-international-europe-colin-mckiff_en.pdf"},
    {"id":"7475","name":"EU/3/14/1280: Public summary of opinion on orphan designation of autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene for the treatment of mucopolysaccharidosis IIIA (Sanfilippo A sy...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/251189/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141280-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-sgsh-gene-treatment-mucopolysaccharidosis-iiia-sanfilippo-sy_en.pdf"},
    {"id":"7476","name":"Presentation - EMA/PDCO approach to neonatology: opportunities (Ralph Bax)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emapdco-approach-neonatology-opportunities-ralph-bax_en.pdf"},
    {"id":"7477","name":"CVMP concept paper on the revision of the committee for veterinary medicinal products (CVMP) and committee for proprietary medicinal products (CPMP), Note for guidance on plastic primary packing materials","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2003-11-03T01:00:00Z","last_updated_date":"2003-11-03T01:00:00Z","reference_number":"EMEA/CVMP/1028/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/cvmp-concept-paper-revision-committee-veterinary-medicinal-products-cvmp-and-committee-proprietary-medicinal-products-cpmp-note-guidance-plastic-primary-packing-materials_en.pdf"},
    {"id":"7479","name":"Rabeprazole: List of nationally authorised medicinal products - PSUSA/00002601/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-27T16:15:00Z","last_updated_date":"2017-07-27T16:16:24Z","reference_number":"EMA/475695/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabeprazole-list-nationally-authorised-medicinal-products-psusa00002601201610_en.pdf"},
    {"id":"7482","name":"Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T11:00:00Z","last_updated_date":"2015-11-20T11:00:00Z","reference_number":"EMA/CHMP/239770/2014 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis-revision-2_en.pdf"},
    {"id":"7483","name":"Committee on herbal medicinal products (HMPC): Meeting report, 11 January 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-02-06T00:00:00Z","last_updated_date":"2007-02-06T00:00:00Z","reference_number":"EMEA/HMPC/45867/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-11-january-2007_en.pdf"},
    {"id":"7484","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Stakeholder's submission form","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T17:00:00Z","last_updated_date":"2013-02-11T17:00:00Z","reference_number":"EMA/639499/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-stakeholders-submission-form_en.pdf"},
    {"id":"7485","name":"Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003; EMEA/H/N/PSR/J/0005; EMEA/H/N/PSR/J/0006","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-23T19:30:00Z","last_updated_date":"2017-02-23T19:30:00Z","reference_number":"EMA/68246/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproteroneethinylestradiol-list-nationally-authorised-medicinal-products-emeahnpsrj0003-emeahnpsrj0005-emeahnpsrj0006_en.pdf"},
    {"id":"7488","name":"Presentation - The refocussed PSUR and a new approach to assessment (Menno van der Elst)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-refocussed-psur-and-new-approach-assessment-menno-van-der-elst_en.pdf"},
    {"id":"7489","name":"Minutes of the second meeting of the EMEA Human Scientific Committees’ Working Party with with Patients’ and Consumers’ Organisations (PCWP)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2007-06-18T02:00:00Z","last_updated_date":"2007-06-18T02:00:00Z","reference_number":"EMEA/211974/2007","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-second-meeting-emea-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp_en.pdf"},
    {"id":"7491","name":"Questions and answers on cyclodextrins used as excipients in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/495747/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-cyclodextrins-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"7492","name":"CVMP summary of positive opinion for Bravecto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-12-13T17:00:00Z","last_updated_date":"2013-12-13T17:00:00Z","reference_number":"EMA/CVMP/627638/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-bravecto_en.pdf"},
    {"id":"7495","name":"European Medicines Agency recommends new contraindication and warning for Rasilez and other aliskiren medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-19T01:00:00Z","last_updated_date":"2009-02-19T01:00:00Z","reference_number":"EMEA/CHMP/89523/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-new-contraindication-and-warning-rasilez-and-other-aliskiren-medicines_en.pdf"},
    {"id":"7497","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 January 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T02:00:00Z","last_updated_date":"2016-10-20T02:00:00Z","reference_number":"EMA/CVMP/9076/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-january-2017_en.pdf"},
    {"id":"7498","name":"Scientific recommendation on classification of advanced-therapy medicinal product: Pseudomonas aeruginosa bacteria genetically modified to secrete oncoproteins of Merkel-cell carcinoma","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-07-01T12:00:00Z","last_updated_date":"2013-07-01T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-product-pseudomonas-aeruginosa-bacteria-genetically-modified-secrete-oncoproteins-merkel-cell-carcinoma_en.pdf"},
    {"id":"7500","name":"Presentation - Biomarkers for PD-1/L1 inhibitors: regulatory considerations (Marc Theoret) - S3.1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-biomarkers-pd-1l1-inhibitors-regulatory-considerations-marc-theoret-s31_en.pdf"},
    {"id":"7501","name":"Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-04-15T02:00:00Z","last_updated_date":"2005-04-15T02:00:00Z","reference_number":"EMEA/CVMP/540/03 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-aspects-pharmaceutical-veterinary-medicines-administration-drinking-water_en.pdf"},
    {"id":"7506","name":"Recommendation for removal of orphan designation at the time of marketing authorisation: Obizur (susoctocog alfa) for the treatment of haemophilia A","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-11-24T01:00:00Z","last_updated_date":"2015-11-24T01:00:00Z","reference_number":"EMA/COMP/656553/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-removal-orphan-designation-time-marketing-authorisation-obizur-susoctocog-alfa-treatment-haemophilia_en.pdf"},
    {"id":"7507","name":"Frequently asked questions on regulatory aspects of Regulation (EC) No 1901/2006 (Paediatric Regulation) amended by Regulation (EC) No 1902/2006","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-09-02T02:00:00Z","last_updated_date":"2008-09-02T02:00:00Z","reference_number":"EMEA/520085/2006 Version 2.0","document_url":"https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-regulatory-aspects-regulation-ec-no-19012006-paediatric-regulation-amended-regulation-ec-no-19022006_en.pdf"},
    {"id":"7508","name":"European Medicines Agency recommends first vaccine for foot-and-mouth disease for authorisation at EU level","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T02:00:00Z","last_updated_date":"2013-05-17T02:00:00Z","reference_number":"EMA/296130/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-first-vaccine-foot-and-mouth-disease-authorisation-eu-level_en.pdf"},
    {"id":"7509","name":"Implementation plan of the Summary of Product Characteristics (SmPC) guideline","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-08T01:00:00Z","last_updated_date":"2013-01-08T01:00:00Z","reference_number":"EMA/655980/2008","document_url":"https://www.ema.europa.eu/en/documents/other/implementation-plan-summary-product-characteristics-smpc-guideline_en.pdf"},
    {"id":"7510","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-03-08T11:45:00Z","last_updated_date":"2018-03-08T11:45:00Z","reference_number":"EMA/113149/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-february-2018_en.pdf"},
    {"id":"7511","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 17-20 May 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"EMA/CHMP/163664/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-may-2010_en.pdf"},
    {"id":"7512","name":"Workshop on Medicines for the Treatment of Pain in children","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-06-20T02:09:21Z","last_updated_date":"2005-06-20T02:09:21Z","reference_number":"EMEA/35431/2005","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-medicines-treatment-pain-children_en.pdf"},
    {"id":"7513","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-06-10T16:00:00Z","last_updated_date":"2016-06-28T16:00:00Z","reference_number":"EMA/274681/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting_en.pdf"},
    {"id":"7515","name":"European Medicines Agency recommends restricting the use of dexrazoxane-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T14:06:34Z","last_updated_date":"2011-06-24T14:06:34Z","reference_number":"EMA/491205/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-dexrazoxane-containing-medicines_en.pdf"},
    {"id":"7516","name":"Presentation - Update on PRIME (Jordi Llinares and Zahra Hanaizi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:31:00Z","last_updated_date":"2018-06-06T17:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-prime-jordi-llinares-and-zahra-hanaizi_en.pdf"},
    {"id":"7518","name":"Opinion following an Article 31 referral for Cisapride International Non-Proprietary Name (INN): Cisapride: Background information and Annexes I, II and IV (English) and Annex III (all languages)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-10-08T01:59:00Z","last_updated_date":"2002-10-08T01:59:00Z","reference_number":"EMEA/CPMP/24844/02","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-31-referral-cisapride-international-non-proprietary-name-inn-cisapride-background-information-and-annexes-i-ii-and-iv-english-and-annex-iii-all-languages_sv.pdf"}},
    {"id":"7519","name":"EU/3/16/1647: Public summary of opinion on orphan designation: Fluocinolone acetonide for the treatment of non-infectious uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2017-08-16T02:00:00Z","reference_number":"EMA/COMP/242323/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161647-public-summary-opinion-orphan-designation-fluocinolone-acetonide-treatment-non-infectious-uveitis_en.pdf"},
    {"id":"7523","name":"Presentation - Defining engagement - awareness and perception of public health measures (Patrick Brown)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-defining-engagement-awareness-and-perception-public-health-measures-patrick-brown_en.pdf"},
    {"id":"7524","name":"Presentation - EMA/EGA workshop - Session 1: Orally Administered Modified Release Products (Gerald Beuerle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-1-orally-administered-modified-release-products-gerald-beuerle_en.pdf"},
    {"id":"7525","name":"Gentamicin: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-11-01T01:00:00Z","last_updated_date":"2001-11-01T01:00:00Z","reference_number":"EMEA/MRL/803/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gentamicin-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7526","name":"Presentation - Community-acquired pneumonia (CAP) (Keith Barker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-community-acquired-pneumonia-cap-keith-barker_en.pdf"},
    {"id":"7527","name":"Presentation - The new Pharmacovigilance legislation: an EMA perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-pharmacovigilance-legislation-ema-perspective_en.pdf"},
    {"id":"7528","name":"EU/3/17/1922: Public summary of opinion on orphan designation : Entospletinib for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T11:37:00Z","last_updated_date":"2018-01-08T11:37:00Z","reference_number":"EMA/623204/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171922-public-summary-opinion-orphan-designation-entospletinib-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"7531","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n19-22 February 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-02-23T00:09:21Z","last_updated_date":"2007-02-23T00:09:21Z","reference_number":"EMEA/82856/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-19-22-february-2007_en.pdf"},
    {"id":"7534","name":"Presentation -  The c-path vision: Sharing data and expertise to accelerate the development of safe and effective therapies for neonates (Martha Brumfield)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-c-path-vision-sharing-data-and-expertise-accelerate-development-safe-and-effective-therapies-neonates-martha-brumfield_en.pdf"},
    {"id":"7535","name":"Presentation given by The Association of the European Self-Medication Industry (AESGP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-given-association-european-self-medication-industry-aesgp_en.pdf"},
    {"id":"7537","name":"Superseded community herbal monograph on Calendula officinalis L., flos - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2018-06-14T02:09:21Z","reference_number":"EMEA/HMPC/179281/2007Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-calendula-officinalis-l-flos-first-version_en.pdf"},
    {"id":"7540","name":"Minutes of the European network of paediatric research at the European Medicines Agency coordinating group members meeting - 6 October 2016","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-11-24T17:25:00Z","last_updated_date":"2016-11-24T17:25:00Z","reference_number":"EMA/683953/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-agency-coordinating-group-members-meeting-6-october-2016_en.pdf"},
    {"id":"7541","name":"CHMP summary of positive opinion for Halaven","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/27541/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-halaven_en.pdf"},
    {"id":"7542","name":"Presentation - Working group 4: Dialogue and interaction with ethics committees (P. Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-4-dialogue-and-interaction-ethics-committees-p-lepola_en.pdf"},
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    {"id":"7610","name":"European Medicines Agency fast-tracks treatment of multiple myeloma for approval in European Union","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-01-29T13:00:00Z","last_updated_date":"2016-01-29T13:00:00Z","reference_number":"EMA/CHMP/56735/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-fast-tracks-treatment-multiple-myeloma-approval-european-union_en.pdf"},
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    {"id":"7614","name":"Presentation - Support offered by the European Medicines Agency for the development of paediatric medicines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-17T15:55:00Z","last_updated_date":"2011-10-17T15:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-support-offered-european-medicines-agency-development-paediatric-medicines_en.pdf"},
    {"id":"7615","name":"Diclofenac use in animals poses a risk to European vultures","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/770700/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/diclofenac-use-animals-poses-risk-european-vultures_en.pdf"},
    {"id":"7618","name":"Overview of comments received on 'Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T18:27:00Z","last_updated_date":"2017-01-03T18:27:00Z","reference_number":"EMA/CVMP/SWP/523387/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-safety-and-residue-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mumslimited-market_en.pdf"},
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    {"id":"7620","name":"Seventh Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1995-09-25T01:00:00Z","last_updated_date":"1995-09-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/seventh-meeting-management-board_en.pdf"},
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    {"id":"7623","name":"Superseded list of references supporting the assessment report on: Menthae piperitae folium Mentha x piperita L., folium (peppermint leaf)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/262645/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-menthae-piperitae-folium-mentha-x-piperita-l-folium-peppermint-leaf_en.pdf"},
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    {"id":"7626","name":"EU/3/05/275: Public summary of positive opinion for orphan designation of estradiol hemihydrate and progesterone for the prevention of  bronchopulmonary dysplasia in premature neonates of less than 30 weeks of gestationa...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-01T01:00:00Z","last_updated_date":"2011-11-18T01:00:00Z","reference_number":"EMEA/COMP/216883/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305275-public-summary-positive-opinion-orphan-designation-estradiol-hemihydrate-and-progesterone-prevention-bronchopulmonary-dysplasia-premature-neonates-less-30-weeks-gestationa_en.pdf"},
    {"id":"7628","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-10-28T14:00:00Z","reference_number":"EMA/PRAC/196120/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-timetable-procedure_en.pdf"},
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    {"id":"7631","name":"Guideline on the treatment of premenstrual dysphoric disorder (PMDD)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2011-08-05T02:00:00Z","reference_number":"EMA/CHMP/607022/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-treatment-premenstrual-dysphoric-disorder-pmdd_en.pdf"},
    {"id":"7632","name":"EU/3/08/564: Public summary of positive opinion for orphan designation\n\nof avian polyclonal IgY antibody against Pseudomonas aeruginosa for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/456746/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308564-public-summary-positive-opinion-orphan-designation-avian-polyclonal-igy-antibody-against-pseudomonas-aeruginosa-treatment-cystic-fibrosis_en.pdf"},
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    {"id":"7693","name":"CHMP post-authorisation summary of positive opinion for Torisel on 23 July 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/464665/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-torisel-23-july-2009_en.pdf"},
    {"id":"7697","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Mandatory therapeutic fields in the centralised procedure, and scientific/public health challenges for the future - Oncology - Paris Kosmidis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-mandatory-therapeutic-fields-centralised-procedure-and-scientificpublic-health-challenges-future-oncology-paris-kosmidis_en.pdf"},
    {"id":"7698","name":"Minutes of the Healthcare Professionals' Organisations Working Group, 4 March 2011","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMA/231456/2011","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-healthcare-professionals-organisations-working-group-4-march-2011_en.pdf"},
    {"id":"7700","name":"Presentation - Strategy and pilot phase for patient registries (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-12T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strategy-and-pilot-phase-patient-registries-xavier-kurz_en.pdf"},
    {"id":"7703","name":"Terebinthinae aetheroleum rectificatum: Summary Report  – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:09:21Z","last_updated_date":"1998-04-01T02:09:21Z","reference_number":"EMEA/MRL/397/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/terebinthinae-aetheroleum-rectificatum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7708","name":"EU/3/07/445: Public summary of positive opinion for orphan designation of antisense oligonucleotide (TATCCGGAGGGCTCGCCATGCTGCT) for the prevention of corneal graft rejection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-12T00:00:00Z","last_updated_date":"2007-12-12T00:00:00Z","reference_number":"EMEA/COMP/108186/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307445-public-summary-positive-opinion-orphan-designation-antisense-oligonucleotide-tatccggagggctcgccatgctgct-prevention-corneal-graft-rejection_en.pdf"},
    {"id":"7709","name":"EU/3/17/1904: Public summary of opinion on orphan designation: Picropodophyllin for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/494333/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171904-public-summary-opinion-orphan-designation-picropodophyllin-treatment-glioma_en.pdf"},
    {"id":"7712","name":"Opinion of the Committee on Herbal Medicinal products on a community herbal monograph for Linum usitatissimum L., semen","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-07-13T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMA/HMPC/165016/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-linum-usitatissimum-l-semen_en.pdf"},
    {"id":"7717","name":"Presentation - Antibiotic development for resistant bacteria: A Pharmacometric-based solution (Paul Ambrose)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antibiotic-development-resistant-bacteria-pharmacometric-based-solution-paul-ambrose_en.pdf"},
    {"id":"7718","name":"Rabbit anti-human thymocyte (concentrate for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010252/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-06T12:00:00Z","last_updated_date":"2016-10-17T19:31:35Z","reference_number":"EMA/532392/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabbit-anti-human-thymocyte-concentrate-solution-infusion-list-nationally-authorised-medicinal-products-psusa00010252201412_en.pdf"},
    {"id":"7719","name":"Questions and answers on the review of medicines containing trimetazidine (20 mg tablets, 35 mg modified release tablet and 20 mg/ml oral solution)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T14:00:00Z","last_updated_date":"2012-10-17T14:00:00Z","reference_number":"EMA/412151/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-medicines-containing-trimetazidine-20-mg-tablets-35-mg-modified-release-tablet-and-20-mgml-oral-solution_sv.pdf"}},
    {"id":"7720","name":"Acitretin :List of nationally authorised medicinal products - PSUSA/00000051/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-13T11:43:00Z","last_updated_date":"2017-06-13T11:50:21Z","reference_number":"EMA/372643/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/acitretin-list-nationally-authorised-medicinal-products-psusa00000051201610_en.pdf"},
    {"id":"7722","name":"Withdrawal assessment report for IXinity","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-09-18T02:00:00Z","last_updated_date":"2013-09-18T02:00:00Z","reference_number":"EMA/CHMP/598935/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ixinity_en.pdf"},
    {"id":"7723","name":"Call for submission of scientific data relating to the assessment of  Melaleucae alternifoliae aetheroleum; Melaleuca alternifolia (Maiden and Betche) Cheel, aetheroleum (tea tree oil)  - First version","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-08-15T02:00:00Z","last_updated_date":"2009-08-15T02:00:00Z","reference_number":"EMEA/HMPC/468683/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-melaleucae-alternifoliae-aetheroleum-melaleuca-alternifolia-maiden-and-betche-cheel-aetheroleum-tea-tree-oil-first-version_en.pdf"},
    {"id":"7725","name":"EU Regulatory Network - Challenges and Opportunities for Croatia - Announcement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/eu-regulatory-network-challenges-and-opportunities-croatia-announcement_en.pdf"},
    {"id":"7726","name":"Pharmaceutics International Inc. Article-31 referral – Start of review","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/425451/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/pharmaceutics-international-inc-article-31-referral-start-review_en.pdf"},
    {"id":"7728","name":"Draft list of references supporting the assessment of Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-08-21T02:00:00Z","last_updated_date":"2013-08-21T02:00:00Z","reference_number":"EMA/HMPC/320929/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-andor-other-species-melaleuca-aetheroleum-first-version_en.pdf"},
    {"id":"7729","name":"Questions and answers on the recommendation for the refusal of the marketing authorization for Mycograb","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2007-03-21T01:00:00Z","last_updated_date":"2007-03-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-mycograb_sv.pdf"}},
    {"id":"7730","name":"Overview of comments received on the draft revision of the guideline on the clinical development of medicinal products for the treatment of HIV infection - EMEA/CPMP/EWP/633/02 Rev. 2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-02-04T01:00:00Z","last_updated_date":"2009-02-04T01:00:00Z","reference_number":"EMEA/301021/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-revision-guideline-clinical-development-medicinal-products-treatment-hiv-infection-emeacpmpewp63302-rev-2_en.pdf"},
    {"id":"7731","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"EMA/76661/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-prac-concludes-diabetes-medicine-canagliflozin-may-contribute-risk-toe-amputation_en.pdf"},
    {"id":"7732","name":"Lincomycin and spectinomycin Article 35 referral - Divergent_position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lincomycin-and-spectinomycin-article-35-referral-divergent_position_en.pdf"},
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    {"id":"7757","name":"Fusafungine Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-09-11T02:00:00Z","last_updated_date":"2015-12-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"7758","name":"Draft list of references supporting the assessment of Carum carvi L., fructus and Carum carvi L. aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-12-22T17:30:00Z","last_updated_date":"2014-12-22T17:30:00Z","reference_number":"EMA/HMPC/242200/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-carum-carvi-l-fructus-and-carum-carvi-l-aetheroleum_en.pdf"},
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    {"id":"7771","name":"European Medicines Agency recommendations on extension of shelf life for Tamiflu","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-08T02:00:00Z","last_updated_date":"2009-05-08T02:00:00Z","reference_number":"EMEA/284971/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommendations-extension-shelf-life-tamiflu_en.pdf"},
    {"id":"7772","name":"Outcome Report on Pilot to involve patients in benefit/risk discussions at CHMP meetings","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-05-08T17:21:00Z","last_updated_date":"2017-05-08T17:21:00Z","reference_number":"EMA/191955/2017","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-report-pilot-involve-patients-benefitrisk-discussions-chmp-meetings_en.pdf"},
    {"id":"7773","name":"Overview of comments received on Community herbal monograph on Plantago lanceolata L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2012-02-24T01:00:00Z","last_updated_date":"2012-02-24T01:00:00Z","reference_number":"EMA/HMPC/353910/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-plantago-lanceolata-l-folium_en.pdf"},
    {"id":"7775","name":"Androstanolone: List of nationally authorised medicinal products - PSUSA/00000212/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-08T02:00:00Z","last_updated_date":"2016-10-17T19:40:12Z","reference_number":"EMA/801642/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/androstanolone-list-nationally-authorised-medicinal-products-psusa00000212201412_en.pdf"},
    {"id":"7776","name":"Assessment report on hamamelis virginiana l., cortex hamamelis virginiana l., folium hamamelis virginiana l., folium et cortex aut ramunculus destillatum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"EMA/HMPC/114585/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/assessment-report-hamamelis-virginiana-l-cortex-hamamelis-virginiana-l-folium-hamamelis-virginiana-l-folium-et-cortex-aut-ramunculus-destillatum_en.pdf"},
    {"id":"7777","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n19-22 October 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-10-23T02:09:21Z","last_updated_date":"2009-10-23T02:09:21Z","reference_number":"EMEA/CHMP/671190/2009 corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-19-22-october-2009_en.pdf"},
    {"id":"7778","name":"Final assessment report on Citrus bergamia Risso et Poiteau, aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-08-28T13:45:00Z","last_updated_date":"2012-08-28T13:45:00Z","reference_number":"EMA/HMPC/56155/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-citrus-bergamia-risso-et-poiteau-aetheroleum_en.pdf"},
    {"id":"7779","name":"Bambuterol: List of nationally authorised medicinal products - PSUSA/00000295/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-18T16:52:00Z","last_updated_date":"2018-07-18T16:54:25Z","reference_number":"EMA/488816/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/bambuterol-list-nationally-authorised-medicinal-products-psusa00000295201712_en.pdf"},
    {"id":"7780","name":"Hydroxyethyl starch Article-107i procedure - PRAC list of questions to be addressed by the stakeholders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"EMA/PRAC/411967/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-prac-list-questions-be-addressed-stakeholders_en.pdf"},
    {"id":"7786","name":"Participants list - Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-12T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/91293/2015","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-second-industry-stakeholder-platform-operation-european-union-pharmacovigilance-legislation_en.pdf"},
    {"id":"7791","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 September 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T17:30:00Z","last_updated_date":"2017-09-08T17:30:00Z","reference_number":"EMA/CVMP/569916/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-september-2017_en.pdf"},
    {"id":"7792","name":"Zydelig Article-20 procedure - PRAC concludes review of Zydelig and issues updated recommendations for use","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/459461/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-prac-concludes-review-zydelig-and-issues-updated-recommendations-use_en.pdf"},
    {"id":"7795","name":"EMEA launches EudraCT database","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-05-06T02:00:00Z","last_updated_date":"2004-05-06T02:00:00Z","reference_number":"EMEA/12589/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-launches-eudract-database_en.pdf"},
    {"id":"7796","name":"CVMP summary of positive opinion for Emdocam","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-06-10T02:00:00Z","last_updated_date":"2011-06-10T02:00:00Z","reference_number":"EMA/CVMP/295707/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-emdocam_en.pdf"},
    {"id":"7797","name":"Superseded list of references supporting the assessment report on: Valeriana officinalis L., radix (EMEA/HMPC/167391/2006) (Valerianae aetheroleum)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-06-20T02:00:00Z","last_updated_date":"2016-06-20T02:00:00Z","reference_number":"EMEA/HMPC/167392/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-valeriana-officinalis-l-radix-emeahmpc1673912006-valerianae-aetheroleum_en.pdf"},
    {"id":"7798","name":"The EMEA innovation task force - Constantinos Ziogas","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-innovation-task-force-constantinos-ziogas_en.pdf"},
    {"id":"7801","name":"Scientific recommendation on classification of advanced therapy medicinal products: allogenic mesenchymal stem cells isolated from umbilical cord","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T16:40:00Z","last_updated_date":"2018-06-27T16:40:00Z","reference_number":"EMA/276793/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogenic-mesenchymal-stem-cells-isolated-umbilical-cord_en.pdf"},
    {"id":"7802","name":"Questions and answers on the review of Vivaglobin (human normal immunoglobulin, solution for injection under the skin)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T13:00:00Z","last_updated_date":"2012-02-17T13:00:00Z","reference_number":"EMA/107736/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-vivaglobin-human-normal-immunoglobulin-solution-injection-under-skin_en.pdf"},
    {"id":"7804","name":"Overview of comments received on 'Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-11-11T10:05:00Z","last_updated_date":"2014-11-11T10:05:00Z","reference_number":"EMA/CHMP/341511/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-medicinal-products-prevention-stroke-and-systemic-embolic-events-patients-non-valvular-atrial-fibrillation_en.pdf"},
    {"id":"7805","name":"Draft list of references for assessment of: Rusci aculeati rhizome Ruscus aculeatus L., rhizome (butcher's broom) - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-09-07T02:00:00Z","last_updated_date":"2007-09-07T02:00:00Z","reference_number":"EMEA/HMPC/372915/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-rusci-aculeati-rhizome-ruscus-aculeatus-l-rhizome-butchers-broom-first-version_en.pdf"},
    {"id":"7806","name":"Superseded list of bibliographic references supporting the HMPC assessment report on Linum usitatissimum L. semen (EMEA/HMPC/167395/2006)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2006-10-25T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"WC500059161.pdf","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-bibliographic-references-supporting-hmpc-assessment-report-linum-usitatissimum-l-semen-emeahmpc1673952006_en.pdf"},
    {"id":"7810","name":"EBV-specific T cells in suspension in human albumin","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-07-11T13:00:00Z","last_updated_date":"2014-07-11T13:00:00Z","reference_number":"EMA/413971/2014","document_url":"https://www.ema.europa.eu/en/documents/report/ebv-specific-t-cells-suspension-human-albumin_en.pdf"},
    {"id":"7811","name":"Agenda - EudraVigilance Training in 2006, A joint initiative of the EMEA with DIA acting as the conference organiser","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-04-10T02:09:21Z","last_updated_date":"2006-04-10T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eudravigilance-training-2006-joint-initiative-emea-dia-acting-conference-organiser_en.pdf-0"},
    {"id":"7813","name":"Presentation - Difficulties encountered – regulatory perspective:\n\nPaediatric Investigation Plans (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-difficulties-encountered-regulatory-perspective-paediatric-investigation-plans-irmgard-eichler_en.pdf"},
    {"id":"7814","name":"CHMP summary of positive opinion for Carmustine Obvius","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-04-27T02:00:00Z","last_updated_date":"2018-04-27T02:00:00Z","reference_number":"EMA/88410/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-carmustine-obvius_en.pdf"},
    {"id":"7815","name":"Standard operating procedure for processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-03-17T01:00:00Z","last_updated_date":"2020-07-30T10:30:00Z","reference_number":"SOP/EMA/0028","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-processing-requests-fee-reduction-falling-under-paragraph-1-article-9-council-regulation-ec-no-29795_en.pdf"},
    {"id":"7818","name":"Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-12T02:00:00Z","last_updated_date":"2016-10-18T10:40:12Z","reference_number":"EMA/607492/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-hydrochloride-phenylephrine-hydrochloride-tropicamide-list-nationally-authorised-medicinal-products-psusa00010390201601_en.pdf"},
    {"id":"7826","name":"EU/3/13/1118: Public summary of opinion on orphan designation:\n\nRecombinant human tripeptidyl-peptidase 1 for the treatment of neuronal ceroid lipofuscinosis type 2","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-05T02:00:00Z","last_updated_date":"2013-04-05T02:00:00Z","reference_number":"EMA/COMP/92274/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131118-public-summary-opinion-orphan-designation-recombinant-human-tripeptidyl-peptidase-1-treatment-neuronal-ceroid-lipofuscinosis-type-2_en.pdf"},
    {"id":"7827","name":"Guideline on Allergen products: Production and quality issues","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"EMEA/CHMP/BWP/304831/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-allergen-products-production-and-quality-issues_en.pdf"},
    {"id":"7828","name":"Letter to European Ombudsman","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-10T16:00:00Z","last_updated_date":"2015-02-10T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-ombudsman_en.pdf"},
    {"id":"7829","name":"Presentation - PRIority MEdicines (PRIME) Support to development of priority medicines for unmet medical needs (Jordi Llinares)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-priority-medicines-prime-support-development-priority-medicines-unmet-medical-needs-jordi-llinares_en.pdf"},
    {"id":"7830","name":"European Medicines Agency reviews treatment recommendations for Fabrazyme","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/CHMP/654389/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-reviews-treatment-recommendations-fabrazyme_en.pdf"},
    {"id":"7832","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - March 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-03-19T16:30:00Z","last_updated_date":"2012-03-19T16:30:00Z","reference_number":"EMA/185313/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-march-2012_en.pdf"},
    {"id":"7833","name":"Barium selenate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/580/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/barium-selenate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7839","name":"Committee on herbal medicinal products (HMPC): Meeting report, 25-26 October 2006","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-11-15T01:00:00Z","last_updated_date":"2006-11-15T01:00:00Z","reference_number":"EMEA/HMPC/450200/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-25-26-october-2006_en.pdf"},
    {"id":"7843","name":"Pravastatin: List of nationally authorised medicinal products -  PSUSA/00002500/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-05T17:20:00Z","last_updated_date":"2017-12-05T17:32:01Z","reference_number":"EMA/806818/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/pravastatin-list-nationally-authorised-medicinal-products-psusa00002500201703_en.pdf"},
    {"id":"7844","name":"Presentation - 4.2 EMA geriatric medicines strategy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-23T01:00:00Z","last_updated_date":"2011-11-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-42-ema-geriatric-medicines-strategy_en.pdf"},
    {"id":"7846","name":"CHMP summary of positive opinion for Tevagrastim","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-07-25T02:00:00Z","last_updated_date":"2008-07-25T02:00:00Z","reference_number":"EMEA/CHMP/360673/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tevagrastim_en.pdf"},
    {"id":"7847","name":"Sample EV test cases","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-21T02:00:00Z","last_updated_date":"2016-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sample-ev-test-cases_en.zip"},
    {"id":"7848","name":"European Medicines Agency recommends first-in-class medicine for treatment of Duchenne muscular dystrophy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/312458/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-first-class-medicine-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"7849","name":"Prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-06-26T15:35:01Z","last_updated_date":"2018-06-26T15:35:01Z","reference_number":"EMA/CHMP/158772/2016/Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/prasugrel-hydrochloride-film-coated-tablets-5-mg-and-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"7851","name":"Fenvalerate: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-05-01T02:00:00Z","last_updated_date":"2006-05-01T02:00:00Z","reference_number":"EMEA/CVMP/167406/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/fenvalerate-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7852","name":"Inductos to be suspended in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T14:00:00Z","last_updated_date":"2015-10-23T14:00:00Z","reference_number":"EMA/683814/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/inductos-be-suspended-eu_en.pdf"},
    {"id":"7854","name":"Overview of comments received on guideline on the investigation of drug interactions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-02T17:00:00Z","last_updated_date":"2013-08-02T17:00:00Z","reference_number":"EMA/CHMP/EWP/125211/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-investigation-drug-interactions_en.pdf"},
    {"id":"7855","name":"Scientific recommendation on classification of advanced therapy medicinal products: Messenger RNAs (mRNAs) encoding immunostimulatory proteins caTLR4, CD40L and CD70 and tumour associated antigens (TAA) tyrosinase, gp100...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-25T18:00:00Z","last_updated_date":"2017-10-25T18:00:00Z","reference_number":"EMA/665187/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-messenger-rnas-mrnas-encoding-immunostimulatory-proteins-catlr4-cd40l-and-cd70-and-tumour-associated-antigens-taa_en.pdf"},
    {"id":"7856","name":"Final list of references supporting the assessment of Tilia tomentosa Moench, flos","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-07-09T18:50:00Z","last_updated_date":"2012-07-09T18:50:00Z","reference_number":"EMA/HMPC/346776/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-tilia-tomentosa-moench-flos_en.pdf"},
    {"id":"7858","name":"Fusafungine Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-14T02:00:00Z","last_updated_date":"2016-04-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fusafungine-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fusafungine-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fusafungine-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fusafungine-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fusafungine-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fusafungine-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fusafungine-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fusafungine-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/fusafungine-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fusafungine-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fusafungine-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fusafungine-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fusafungine-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fusafungine-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fusafungine-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fusafungine-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fusafungine-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fusafungine-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fusafungine-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fusafungine-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fusafungine-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fusafungine-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"7861","name":"EU/3/17/1896: Public summary of opinion on orphan designation: Sirolimus for the treatment of pachyonychia congenita","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-14T16:54:00Z","last_updated_date":"2017-08-14T16:54:00Z","reference_number":"EMA/391493/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171896-public-summary-opinion-orphan-designation-sirolimus-treatment-pachyonychia-congenita_en.pdf"},
    {"id":"7863","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (Belgium, Luxembourg)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-belgium-luxembourg_en.pdf"},
    {"id":"7864","name":"Global development challenges: Classical and advanced therapy medicinal products - Beatriz Silva Lima","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/global-development-challenges-classical-and-advanced-therapy-medicinal-products-beatriz-silva-lima_en.pdf"},
    {"id":"7865","name":"What has changed for drug development?: Kerstin Westermark","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/what-has-changed-drug-development-kerstin-westermark_en.pdf"},
    {"id":"7866","name":"CHMP summary of positive opinion for DuoResp Spiromax","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/CHMP/68037/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-duoresp-spiromax_en.pdf"},
    {"id":"7869","name":"EU/3/01/040: Public summary of positive opinion for orphan designation of fomepizole for the treatment of methanol poisoning","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T00:00:00Z","last_updated_date":"2011-05-06T01:00:00Z","reference_number":"EMEA/COMP/1288/03draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301040-public-summary-positive-opinion-orphan-designation-fomepizole-treatment-methanol-poisoning_en.pdf"},
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    {"id":"7910","name":"News bulletin for small and medium-sized enterprises - Issue 42","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-02-06T13:30:00Z","last_updated_date":"2018-02-06T13:30:00Z","reference_number":"Issue 42","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-42_en.pdf"},
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    {"id":"7912","name":"Questions and answers relating to service concession: meeting and training organisation (EMA/2016/43/RS)","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-09-15T12:00:00Z","last_updated_date":"2016-09-20T14:00:00Z","reference_number":"EMA/600716/2016 v1.0","document_url":"https://www.ema.europa.eu/en/documents/procurement/questions-and-answers-relating-service-concession-meeting-and-training-organisation-ema201643rs_en.pdf"},
    {"id":"7913","name":"Presentation - Immune Reconstitution Inflammatory Syndrome, Joseph Berger","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immune-reconstitution-inflammatory-syndrome-joseph-berger_en.pdf"},
    {"id":"7914","name":"EU/3/07/465: Committee for Orphan Medicinal ProductsPublic summary of positive opinion for orphan designation of L-threo-3,4-dihydroxyphenylserine for the treatment of orthostatic hypotension in patients with pure auto...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-08-28T02:00:00Z","last_updated_date":"2022-01-28T02:00:00Z","reference_number":"EMEA/COMP/519317/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307465-committee-orphan-medicinal-productspublic-summary-positive-opinion-orphan-designation-l-threo-34-dihydroxyphenylserine-treatment-orthostatic-hypotension-patients-pure-auto_en.pdf"},
    {"id":"7915","name":"EU/3/18/1986: Public summary of opinion on orphan designation: Seletalisib for the treatment of activated phosphoinositide 3-kinase delta syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/52868/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181986-public-summary-opinion-orphan-designation-seletalisib-treatment-activated-phosphoinositide-3-kinase-delta-syndrome_en.pdf"},
    {"id":"7916","name":"Draft assessment report on Commiphora molmol Engler, gummi-resina","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2010-11-16T01:00:00Z","last_updated_date":"2010-11-16T01:00:00Z","reference_number":"EMA/HMPC/96910/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"7919","name":"CHMP post-authorisation summary of positive opinion for HyQvia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/CHMP/37597/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-hyqvia_en.pdf"},
    {"id":"7920","name":"Yasminelle - Article 5(11) referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:08:21Z","last_updated_date":"2008-07-03T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/yasminelle-article-511-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"7921","name":"Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T18:52:00Z","last_updated_date":"2017-10-26T18:55:44Z","reference_number":"EMA/716513/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluconazole-list-nationally-authorised-medicinal-products-psusa00001404201703_en.pdf"},
    {"id":"7922","name":"Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 14-16 September 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-09-20T02:00:00Z","last_updated_date":"2010-09-20T02:00:00Z","reference_number":"EMA/CVMP/559704/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-september-2010_en.pdf"},
    {"id":"7923","name":"EU/3/12/984: Public summary of opinion on orphan designation: 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2015-03-10T12:00:00Z","reference_number":"EMA/COMP/219979/2012 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312984-public-summary-opinion-orphan-designation-1-3r-3-4-amino-3-4-phenoxyphenyl-1h-pyrazolo34-dpyrimidin-1-yl-1-piperidinyl-2-propen-1-one-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"7924","name":"EU/3/14/1235: Public summary of opinion on orphan designation: Mixture of recombinant human IgG1 monoclonal antibodies against human cytomegalovirus envelope glycoproteins for the prevention of congenital cytomegalovirus...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-01T03:00:00Z","last_updated_date":"2015-05-08T03:00:00Z","reference_number":"EMA/COMP/29801/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141235-public-summary-opinion-orphan-designation-mixture-recombinant-human-igg1-monoclonal-antibodies-against-human-cytomegalovirus-envelope-glycoproteins-prevention-congenital-cytomegalovirus_en.pdf"},
    {"id":"7925","name":"Tetrabenazine:CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation-PSUSA/00002911/201410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T12:30:00Z","last_updated_date":"2016-10-19T12:44:33Z","reference_number":"EMA/517086/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/tetrabenazinecmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002911201410_en.pdf"},
    {"id":"7926","name":"New pharmaceutical legislation enters into force on 20 May 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-03T02:00:00Z","last_updated_date":"2009-05-03T02:00:00Z","reference_number":"EMEA/12332/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-pharmaceutical-legislation-enters-force-20-may-2004_en.pdf"},
    {"id":"7929","name":"Octagam Article-31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/octagam-article-31-referral-assessment-report_en.pdf"},
    {"id":"7930","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Signifor (pasireotide) for the treatment of Cushing’s disease","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-06-29T13:38:00Z","last_updated_date":"2022-06-14T13:38:00Z","reference_number":"EMA/COMP/93349/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-signifor-pasireotide-treatment-cushings-disease_en.pdf"},
    {"id":"7932","name":"Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated), haemophilus type b conjugate vaccine: List of nationally authorised medicinal products - PSUSA/00001124/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-07-17T14:00:00Z","last_updated_date":"2016-10-17T19:52:27Z","reference_number":"EMA/483660/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheria-tetanus-pertussis-acellular-component-poliomyelitis-inactivated-haemophilus-type-b-conjugate-vaccine-list-nationally-authorised-medicinal-products-psusa00001124201411_en.pdf"},
    {"id":"7933","name":"Agenda - PRAC draft agenda of meeting 3-6 September 2018","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-09-03T18:44:00Z","last_updated_date":"2018-09-03T18:44:00Z","reference_number":"EMA/PRAC/596678/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-3-6-september-2018_en.pdf"},
    {"id":"7937","name":"Overview of comments received on 'Reflection paper on the use of cocrystals and other solid state forms of active substances in medicinal products’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-16T18:10:00Z","last_updated_date":"2015-07-16T18:10:00Z","reference_number":"EMA/CHMP/CVMP/QWP/284007/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-use-cocrystals-and-other-solid-state-forms-active-substances-medicinal-products_en.pdf"},
    {"id":"7938","name":"Guideline on quality data requirements for veterinary medicinal products intended for minor uses or minor species","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-07-20T02:00:00Z","last_updated_date":"2006-07-20T02:00:00Z","reference_number":"EMEA/CVMP/QWP/128710/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-data-requirements-veterinary-medicinal-products-intended-minor-uses-or-minor-species_en.pdf"},
    {"id":"7943","name":"Overview of comments received on reflection paper on the use of third- and fourth-generation cephalosporins in food-producing animals in the European Union: development of tesistance and impact on human and animal health","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-17T02:00:00Z","last_updated_date":"2009-04-17T02:00:00Z","reference_number":"EMEA/CVMP/SAGAM/464096/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-use-third-and-fourth-generation-cephalosporins-food-producing-animals-european-union-development-tesistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"7945","name":"EMEA conditions for informatics ( IT ) contracts","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-01T02:00:00Z","last_updated_date":"2008-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/emea-conditions-informatics-it-contracts_en.pdf"},
    {"id":"7946","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Chenodeoxycholic acid sigma-tau (chenodeoxycholic acid) for the treatment of inborn errors in primary bile acid synthesis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2017-05-11T11:29:00Z","last_updated_date":"2017-06-29T11:29:00Z","reference_number":"EMA/39662/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-chenodeoxycholic-acid-sigma-tau-chenodeoxycholic-acid-treatment-inborn-errors-primary-bile-acid-synthesis_en.pdf"},
    {"id":"7948","name":"Kogenate Bayer and Helixate NexGen Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-03-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-notification_en.pdf"},
    {"id":"7951","name":"Miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation -PSUSA/...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T02:00:00Z","last_updated_date":"2016-10-18T11:46:16Z","reference_number":"EMA/269956/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/miconazole-hydrocortisone-miconazole-nitrate-miconazole-nitrate-zinc-oxide-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa_en.pdf"},
    {"id":"7953","name":"European Medicines Agency advises on compassionate use of sofosbuvir","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T14:00:00Z","last_updated_date":"2013-10-25T14:00:00Z","reference_number":"EMA/652584/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-advises-compassionate-use-sofosbuvir_en.pdf"},
    {"id":"7954","name":"Superseded community herbal monograph on Trigonella foenumgraecum L., semen","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2022-08-30T01:00:00Z","last_updated_date":"2022-08-30T01:00:00Z","reference_number":"EMA/HMPC/146221/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-trigonella-foenumgraecum-l-semen_en.pdf"},
    {"id":"7955","name":"Public statement on HumaSPECT (votumumab) - Non-renewal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-02-24T00:09:21Z","last_updated_date":"2004-02-24T00:09:21Z","reference_number":"EMEA/3885/04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-humaspect-votumumab-non-renewal-marketing-authorisation-european-union_en.pdf"},
    {"id":"7957","name":"Opinion of the HMPC on a European Union herbal monograph on Althaea officinalis L., radix","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T15:14:00Z","last_updated_date":"2016-11-04T15:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-althaea-officinalis-l-radix_en.pdf"},
    {"id":"7958","name":"Finasteride : List of nationally authorised medicinal products     - PSUSA/00001392/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-30T19:05:00Z","last_updated_date":"2017-05-30T19:15:17Z","reference_number":"EMA/344631/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/finasteride-list-nationally-authorised-medicinal-products-psusa00001392201608_en.pdf"},
    {"id":"7960","name":"Supply shortage of Cerezyme – updated treatment recommendations required","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-08-14T02:00:00Z","last_updated_date":"2009-08-14T02:00:00Z","reference_number":"EMEA/512960/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/supply-shortage-cerezyme-updated-treatment-recommendations-required_en.pdf"},
    {"id":"7963","name":"Boric acid and borate used as excipients - Report published in support of the ‘Questions and answers on boric acid and borates used as excipients in medicinal products for human use’","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/765436/2012","document_url":"https://www.ema.europa.eu/en/documents/report/boric-acid-and-borate-used-excipients-report-published-support-questions-and-answers-boric-acid-and-borates-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"7964","name":"5 Fluorouracil (topical application): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010000/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-13T01:00:00Z","last_updated_date":"2016-10-17T16:37:37Z","reference_number":"EMA/757666/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/5-fluorouracil-topical-application-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010000201412_en.pdf"},
    {"id":"7965","name":"Superseded assessment report for the development of a community monograph and for inclusion of herbal substance(s), preparation(s) or combinations thereof in the list Eleutherococcus senticosus (Ruppr. et Maxim.) Maxim.,...","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2014-10-06T02:09:21Z","reference_number":"EMEA/HMPC/232403/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-development-community-monograph-and-inclusion-herbal-substances-preparations-or-combinations-thereof-list-eleutherococcus-senticosus-ruppr-et-maxim-maxim_en.pdf"},
    {"id":"7966","name":"CHMP summary of positive opinion for Fycompa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/CHMP/242764/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fycompa_en.pdf"},
    {"id":"7969","name":"Presentation - PK data for supporting PK-PD analyses: essential PK data (Elisabet Nielsen, Lena Friberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pk-data-supporting-pk-pd-analyses-essential-pk-data-elisabet-nielsen-lena-friberg_en.pdf"},
    {"id":"7970","name":"EU/3/17/1850: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase for treatment of ornithine transcarbamylase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/159927/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171850-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-lk03-encoding-human-ornithine-transcarbamylase-treatment-ornithine-transcarbamylase-deficiency_en.pdf"},
    {"id":"7971","name":"Presentation - A Subgroup or a Subpopulation (Wang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subgroup-or-subpopulation-wang_en.pdf"},
    {"id":"7974","name":"Presentation - Topics specific to veterinary medicinal products (VMPs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topics-specific-veterinary-medicinal-products-vmps_en.pdf"},
    {"id":"7975","name":"Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin (modification of ADI and MRL)","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-04-28T15:53:00Z","last_updated_date":"2015-04-28T15:53:00Z","reference_number":"EMA/CVMP/380415/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-tulathromycin-modification-adi-and-mrl_en.pdf"},
    {"id":"7976","name":"EU/3/18/2009: Public summary of opinion on orphan designation: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T13:00:00Z","last_updated_date":"2022-08-17T16:42:00Z","reference_number":"EMA/198204/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182009-public-summary-opinion-orphan-designation-autologous-dendritic-cells-pulsed-killed-ovarian-cancer-cells-and-matured-tlr3-ligand-ex-vivo-treatment-ovarian-cancer_en.pdf"},
    {"id":"7977","name":"Organisational matters - CHMP meeting 16-19 January 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-23T17:35:00Z","last_updated_date":"2012-01-23T17:35:00Z","reference_number":"EMA/CHMP/8909/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-16-19-january-2012_en.pdf"},
    {"id":"7978","name":"Draft guideline on the development medicinal substances contained in drug-eluting (medicinal substance-eluting) coronary stents","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-03-22T01:00:00Z","last_updated_date":"2007-03-22T01:00:00Z","reference_number":"EMEA/CHMP/EWP/110540/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-medicinal-substances-contained-drug-eluting-medicinal-substance-eluting-coronary-stents_en.pdf"},
    {"id":"7979","name":"EU/3/14/1266: Public summary of opinion on orphan designation: Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 for the treatment of B-lymphoblastic leukae...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-06-04T02:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/COMP/157129/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141266-public-summary-opinion-orphan-designation-autologous-t-cells-transduced-lentiviral-vector-containing-chimeric-antigen-receptor-directed-against-cd19-treatment-b-lymphoblastic-leukae_en.pdf"},
    {"id":"7980","name":"Withdrawal letter : Tygacil","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-04-22T02:00:00Z","last_updated_date":"2008-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-tygacil_en.pdf"},
    {"id":"7981","name":"Superseded assessment report on Valeriana officinalis L., radix (Valerianae aetheroleum)","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-06-20T02:00:00Z","last_updated_date":"2016-06-20T02:00:00Z","reference_number":"EMEA/HMPC/167391/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-valeriana-officinalis-l-radix-valerianae-aetheroleum_en.pdf"},
    {"id":"7983","name":"Draft assessment report on Origanum dictamnus L., herba - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-02-04T12:35:00Z","last_updated_date":"2013-02-04T12:35:00Z","reference_number":"EMA/HMPC/200431/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-origanum-dictamnus-l-herba-first-version_en.pdf"},
    {"id":"7984","name":"Helixate NexGen Article-20 procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T13:00:00Z","last_updated_date":"2013-12-20T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/helixate-nexgen-article-20-procedure-annex-iii_en.pdf"},
    {"id":"7985","name":"EU/3/05/331: Public summary of positive opinion for orphan designation of recombinant microbial lipase for the treatment of malabsorption due to exocrine pancreatic enzyme insufficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-03-13T00:00:00Z","last_updated_date":"2013-03-01T13:00:00Z","reference_number":"EMEA/COMP/315315/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305331-public-summary-positive-opinion-orphan-designation-recombinant-microbial-lipase-treatment-malabsorption-due-exocrine-pancreatic-enzyme-insufficiency_en.pdf"},
    {"id":"7987","name":"EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/142655/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-confirms-recommendations-minimise-ketoacidosis-risk-sglt2-inhibitors-diabetes_en.pdf"},
    {"id":"7988","name":"Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation: May 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-05-22T19:01:03Z","last_updated_date":"2012-05-22T19:01:03Z","reference_number":"EMA/COMP/278126/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-meeting-report-review-applications-orphan-designation-may-2012_en.pdf"},
    {"id":"7989","name":"Flupirtine-containing medicines Article-107i procedure - PRAC recommends restricting the use of flupirtine-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"EMA/362055/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-prac-recommends-restricting-use-flupirtine-containing-medicines_en.pdf"},
    {"id":"7994","name":"Questions and answers on the cessation of supply of Regranex (becaplermin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/CHMP/386043/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-cessation-supply-regranex-becaplermin_en.pdf"},
    {"id":"7995","name":"Presentation - Variations - progress in worksharing CMDv comments (Esther Werner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-variations-progress-worksharing-cmdv-comments-esther-werner_en.pdf"},
    {"id":"7996","name":"Ricini oleum: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/399/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ricini-oleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"7997","name":"Agenda: Workshop on paediatric formulations for assessors in national regulatory agencies","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"EMA/53312/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-paediatric-formulations-assessors-national-regulatory-agencies_en.pdf"},
    {"id":"7999","name":"Paclitaxel: List of nationally authorised medicinal products - PSUSA/00002264/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-25T02:00:00Z","last_updated_date":"2016-10-25T19:37:13Z","reference_number":"EMA/706629/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/paclitaxel-list-nationally-authorised-medicinal-products-psusa00002264201512_en.pdf"},
    {"id":"8001","name":"Presentation - Regulatory view (Jan Mueller-Berghaus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T01:00:00Z","last_updated_date":"2013-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-view-jan-mueller-berghaus_en.pdf"},
    {"id":"8002","name":"Agenda - Homeopathic Workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-11-26T00:09:21Z","last_updated_date":"2006-11-26T00:09:21Z","reference_number":"EMEA/314681/2006","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-homeopathic-workshop_en.pdf"},
    {"id":"8003","name":"Brief summary of the existing systems on collecting data: United Kingdom","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-united-kingdom_en.pdf"},
    {"id":"8005","name":"Presentation - Key points from introductory session: Setting the scene (Karri Penttila)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-points-introductory-session-setting-scene-karri-penttila_en.pdf"},
    {"id":"8011","name":"Request for an opinion regarding a request pursuant to Article-30(3) of Regulation (EC) No 726/2004 in relation to the potential risk for the consumer resulting from the use of lidocaine in food producing species","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-22T14:00:00Z","last_updated_date":"2015-04-22T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/request-opinion-regarding-request-pursuant-article-303-regulation-ec-no-7262004-relation-potential-risk-consumer-resulting-use-lidocaine-food-producing-species_en.pdf"},
    {"id":"8012","name":"Tolperisone: Product information as approved by the CHMP on 21 June 2012, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T12:00:00Z","last_updated_date":"2012-06-22T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/tolperisone-product-information-approved-chmp-21-june-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"8013","name":"Vivaglobin Article-36 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/vivaglobin-article-36-referral-annex-iii_en.pdf"},
    {"id":"8014","name":"Committee for Medicinal Products for Human Use (CHMP) - September 2004 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2004-09-28T02:00:00Z","last_updated_date":"2004-09-28T02:00:00Z","reference_number":"EMEA/CHMP/269/2004","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-september-2004-plenary-meeting-monthly-report_en.pdf"},
    {"id":"8015","name":"Annex C Response Questionnaire","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-11-12T01:00:00Z","last_updated_date":"2009-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-c-response-questionnaire_en.xls"},
    {"id":"8016","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 26-27 March 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-04-10T17:40:00Z","last_updated_date":"2018-04-10T17:40:00Z","reference_number":"EMA/HMPC/213739/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-26-27-march-2018_en.pdf"},
    {"id":"8017","name":"Botulinum toxin a - haemagglutinin complex: List of nationally authorised medicinal products - PSUSA/00000427/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-25T02:00:00Z","last_updated_date":"2016-10-25T19:31:49Z","reference_number":"EMA/706149/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/botulinum-toxin-haemagglutinin-complex-list-nationally-authorised-medicinal-products-psusa00000427201512_en.pdf"},
    {"id":"8019","name":"Statement of authority and confidentiality commitment from the United States Food and Drug Administration not to publicly disclose non-public information shared by the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-09-15T02:00:00Z","last_updated_date":"2010-09-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/statement-authority-and-confidentiality-commitment-united-states-food-and-drug-administration-not-publicly-disclose-non-public-information-shared-european-medicines-agency_en.pdf"},
    {"id":"8021","name":"Committee for Orphan Medicinal Products: September 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-09-14T02:00:00Z","last_updated_date":"2005-09-14T02:00:00Z","reference_number":"EMEA/COMP/299233/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-september-2005-meeting_en.pdf"},
    {"id":"8022","name":"Public hearing on valproate - Written interventions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-02T19:30:00Z","last_updated_date":"2017-10-02T19:30:00Z","reference_number":"EMA/645752/2017","document_url":"https://www.ema.europa.eu/en/documents/other/public-hearing-valproate-written-interventions_en.pdf"},
    {"id":"8023","name":"EU/3/16/1778: Public summary of positive opinion for orphan designation of budesonide for the treatment of primary IgA nephropathy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2016-12-13T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161778-public-summary-positive-opinion-orphan-designation-budesonide-treatment-primary-iga-nephropathy_en.pdf"},
    {"id":"8027","name":"Committee for medicinal products for veterinary use: Meeting of 13 to 15 July 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-07-16T14:39:21Z","last_updated_date":"2004-07-16T14:39:21Z","reference_number":"EMEA/CVMP/713/04/Rev 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-13-15-july-2004_en.pdf"},
    {"id":"8028","name":"Presentation - 1.4 Regulatory pathways for supporting novel methodologies and opportunities for interactions with regulators (Ine Skottheim Rusten, Anja Schiel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-14-regulatory-pathways-supporting-novel-methodologies-and-opportunities-interactions-regulators-ine-skottheim-rusten-anja-schiel_en.pdf"},
    {"id":"8029","name":"Agenda - 2015 Forum on bioequivalence inspections","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-10-12T13:00:00Z","last_updated_date":"2015-10-12T13:00:00Z","reference_number":"EMA/670206/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2015-forum-bioequivalence-inspections_en.pdf"},
    {"id":"8030","name":"Presentation - The update of the multiplicity guideline (Norbert Benda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-multiplicity-guideline-norbert-benda_en.pdf"},
    {"id":"8031","name":"Presentation - Approaches to advancing patient focussed outcomes assessment in clinical trials (Jeremy Hobart)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-approaches-advancing-patient-focussed-outcomes-assessment-clinical-trials-jeremy-hobart_en.pdf"},
    {"id":"8033","name":"Points to consider on the reduction, elimination or substitution of Thiomersal in vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-04-26T02:00:00Z","last_updated_date":"2001-04-26T02:00:00Z","reference_number":"CPMP/BWP/2517/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-reduction-elimination-or-substitution-thiomersal-vaccines_en.pdf"},
    {"id":"8035","name":"Rules of procedure on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-04-15T14:00:00Z","last_updated_date":"2023-02-17T11:25:00Z","reference_number":"EMA/11523/2023 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_bg.pdf","es":"https://www.ema.europa.eu/es/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_cs.pdf","da":"https://www.ema.europa.eu/da/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_da.pdf","de":"https://www.ema.europa.eu/de/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_de.pdf","et":"https://www.ema.europa.eu/et/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_et.pdf","el":"https://www.ema.europa.eu/el/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_hr.pdf","it":"https://www.ema.europa.eu/it/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/regulatory-procedural-guideline/rules-procedure-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_sv.pdf"}},
    {"id":"8036","name":"Presentation - Medication errors in children (Ian Chi Kei Wong)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medication-errors-children-ian-chi-kei-wong_en.pdf"},
    {"id":"8038","name":"Recognition criteria for self-assessment - European Network of Paediatric Reserach at the European Medicines Agency: European Cystic Fibrosis Society - Clinical Trials Network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/867379/2011","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-reserach-european-medicines-agency-european-cystic-fibrosis-society-clinical-trials-network_en.pdf"},
    {"id":"8039","name":"Cefquinome (Extension to pigs): Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/405/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefquinome-extension-pigs-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"8042","name":"Letter of invitation to tender - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"EMA/755550/201212","document_url":"https://www.ema.europa.eu/en/documents/other/letter-invitation-tender-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"8045","name":"Dissemination of information - Martin Harvey","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-08T02:00:00Z","last_updated_date":"2003-05-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/dissemination-information-martin-harvey_en.pdf"},
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    {"id":"8051","name":"Questions and answers relating to service concession pharmacovigilance training – EMA/2014/35/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2015-03-09T01:00:00Z","last_updated_date":"2015-04-14T11:55:00Z","reference_number":"EMA/160758/2015","document_url":"https://www.ema.europa.eu/en/documents/procurement/questions-and-answers-relating-service-concession-pharmacovigilance-training-ema201435re_en.pdf"},
    {"id":"8054","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 14-15 January 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-02-07T11:06:00Z","last_updated_date":"2013-02-07T11:06:00Z","reference_number":"EMA/HMPC/44844/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-14-15-january-2013_en.pdf"},
    {"id":"8055","name":"Minutes of the second PCWP meeting with all eligible patients’ and consumers’ organisations, 8 Dec 2009","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"EMA/63330/2010","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-second-pcwp-meeting-all-eligible-patients-and-consumers-organisations-8-dec-2009_en.pdf"},
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    {"id":"8060","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - May 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-05-31T13:25:00Z","last_updated_date":"2012-05-31T13:25:00Z","reference_number":"EMA/CHMP/PhVWP/339710/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-may-2012_en.pdf"},
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    {"id":"8065","name":"Draft assessment report on Origanum majorana L., herba","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-02-15T17:15:00Z","last_updated_date":"2016-02-15T17:15:00Z","reference_number":"EMA/HMPC/63479/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-origanum-majorana-l-herba_en.pdf"},
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    {"id":"8068","name":"Agenda and registration form - EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area (San Marino)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-29T13:30:00Z","reference_number":"Course #15520","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-european-economic-area-san-marino_en.pdf"},
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    {"id":"8070","name":"Final overview of comments received on Public statement on Paeonia lactiflora Pallas, radix (Paeoniae radix alba)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2017-04-25T16:47:00Z","last_updated_date":"2017-04-25T16:47:00Z","reference_number":"EMA/HMPC/610809/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/final-overview-comments-received-public-statement-paeonia-lactiflora-pallas-radix-paeoniae-radix-alba_en.pdf"},
    {"id":"8076","name":"Fortipan Combi D - Article 29 refferal - Annex I-III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fortipan-combi-d-article-29-refferal-annex-i-iii_sv.pdf"}},
    {"id":"8078","name":"Nafarelin: List of nationally authorised medicinal products - PSUSA/00002105/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2016-10-18T12:21:21Z","reference_number":"EMA/707735/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/nafarelin-list-nationally-authorised-medicinal-products-psusa00002105201502_en.pdf"},
    {"id":"8080","name":"Standard Operating Procedure for Creating the SAFE Print","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-06-07T02:00:00Z","last_updated_date":"2007-06-07T02:00:00Z","reference_number":"SOP/H/3026","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-creating-safe-print_en.pdf"},
    {"id":"8081","name":"EU/3/13/1189: Public summary of opinion on orphan designation:\n\nMexiletine hydrochloride for the treatment of myotonic disorders","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2013-10-31T01:00:00Z","reference_number":"EMA/COMP/554729/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131189-public-summary-opinion-orphan-designation-mexiletine-hydrochloride-treatment-myotonic-disorders_en.pdf"},
    {"id":"8082","name":"Retinoid Article-31 referral - Updated measures for pregnancy prevention during retinoid use","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"EMA/254364/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_sv.pdf"}},
    {"id":"8084","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 9-11 December 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-12-21T11:15:00Z","last_updated_date":"2015-12-21T11:15:00Z","reference_number":"EMA/PDCO/789214/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-9-11-december-2015_en.pdf"},
    {"id":"8085","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Mars Di Bartolomeo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-mars-di-bartolomeo_en.pdf"},
    {"id":"8086","name":"Annex III: Draft donation agreement - Donation of EMA assets no. EMA/2014/28/IS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-iii-draft-donation-agreement-donation-ema-assets-no-ema201428is_en.pdf"},
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    {"id":"8094","name":"Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle-stimulating hormone (r-hFSH)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-03-06T12:00:03Z","last_updated_date":"2013-03-06T12:00:03Z","reference_number":"EMA/CHMP/BMWP/671292/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-follicle-stimulating-hormone-r-hfsh_en.pdf"},
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    {"id":"8096","name":"Withdrawal letter : Docetaxel Sun","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-docetaxel-sun_en.pdf"},
    {"id":"8097","name":"Implementation of Q8, Q9 & Q10 - Georges France","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/implementation-q8-q9-q10-georges-france_en.pdf"},
    {"id":"8098","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Recombinant parathyroid hormone for treatment of hypoparathyroidism","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T12:45:00Z","last_updated_date":"2014-10-21T12:45:00Z","reference_number":"EMA/485026/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-recombinant-parathyroid-hormone-treatment-hypoparathyroidism_en.pdf"},
    {"id":"8100","name":"EU/3/11/877: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 9 containing the human sulfamidase gene for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2011-07-12T02:00:00Z","reference_number":"EMA/COMP/290516/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311877-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-containing-human-sulfamidase-gene-treatment-mucopolysaccharidosis-type-iiia-sanfilippo-syndrome_en.pdf"},
    {"id":"8101","name":"CHMP summary of positive opinion for Imraldi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"EMA/358372/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imraldi_en.pdf"},
    {"id":"8102","name":"EU/3/07/459: Public summary of positive opinion for orphan designation of \n\n1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine, hydrochloride for the treatment of narcolepsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-12T01:00:00Z","last_updated_date":"2007-12-12T01:00:00Z","reference_number":"EMEA/COMP/246680/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307459-public-summary-positive-opinion-orphan-designation-1-3-3-4-chlorophenylpropoxypropylpiperidine-hydrochloride-treatment-narcolepsy_en.pdf"},
    {"id":"8104","name":"Annex H: Standard expenses form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-07-01T02:00:00Z","last_updated_date":"2008-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-h-standard-expenses-form_en.pdf"},
    {"id":"8107","name":"EU/3/17/1849: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human alpha-galactosidase A gene for treatment of Fabry disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/159926/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171849-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-alpha-galactosidase-gene-treatment-fabry-disease_en.pdf"},
    {"id":"8109","name":"CHMP summary of positive opinion for Cabometyx","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/498981/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cabometyx_en.pdf"},
    {"id":"8111","name":"Presentation - Interaction with patients and consumers (2013): Review of safety communications (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-patients-and-consumers-2013-review-safety-communications-nathalie-bere_en.pdf"},
    {"id":"8112","name":"Minutes - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (27 June 2017)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"EMA/355452/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-27-june-2017_en.pdf"},
    {"id":"8113","name":"Guidelines and concept papers adopted during the CHMP meeting 19-22 September 2011 (Corr.)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-10-18T14:56:00Z","reference_number":"EMA/764325/2011","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-19-22-september-2011-corr_en.pdf"},
    {"id":"8114","name":"Confidentiality arrangements concluded between the European Union (European Commission and European Medicines Agency) and the United States Food and Drug Administration / Department of Health and Human Services - Impleme...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-09-16T02:00:00Z","last_updated_date":"2004-09-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/confidentiality-arrangements-concluded-between-european-union-european-commission-and-european-medicines-agency-and-united-states-food-and-drug-administration-department-health-and-human-services_en.pdf"},
    {"id":"8115","name":"Recognition criteria for self assessment - Enpr-EMA: The Paediatric Trial\n\nNetwork (AMIKI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2011-01-07T00:31:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-paediatric-trial-network-amiki_en.pdf"},
    {"id":"8116","name":"Adrenaline auto-injectors Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-08-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/adrenaline-auto-injectors-article-31-referral-annex-iii_no.pdf"}},
    {"id":"8119","name":"EU/3/12/1019: Public summary of opinion on orphan designation: Ramucirumab for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2016-08-11T16:00:00Z","reference_number":"EMA/COMP/358556/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121019-public-summary-opinion-orphan-designation-ramucirumab-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"8120","name":"Meeting report from Fate of veterinary medicinal products in manure Focus Group Meeting - London, 23 June 2009","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-10-07T02:09:21Z","last_updated_date":"2009-10-07T02:09:21Z","reference_number":"EMEA/CVMP/ERA/400210/2009","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-fate-veterinary-medicinal-products-manure-focus-group-meeting-london-23-june-2009_en.pdf"},
    {"id":"8124","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - Annex I-III - Forxiga","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-05-08T14:00:00Z","last_updated_date":"2017-05-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-forxiga_no.pdf"}},
    {"id":"8126","name":"Presentation - Changing phage cocktails to match developing resistance (Gilbert Verbeken)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-changing-phage-cocktails-match-developing-resistance-gilbert-verbeken_en.pdf"},
    {"id":"8127","name":"Spectinomycin (Extension to all food producing species): Summary report (5) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/MRL/826/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spectinomycin-extension-all-food-producing-species-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"8129","name":"Questions and answers on design-space verification","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-04T17:45:00Z","last_updated_date":"2013-11-04T17:45:00Z","reference_number":"EMA/603905/2013","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-design-space-verification_en.pdf"},
    {"id":"8130","name":"Guideline on good pharmacovigilance practices: Module XV – Safety communication with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-01-24T18:00:00Z","last_updated_date":"2013-01-24T18:00:00Z","reference_number":"EMA/35829/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xv-safety-communication-tracked-changes_en.pdf"},
    {"id":"8131","name":"Granisetron: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"8132","name":"Centralised Procedure Analysis of Performance Indicators; Extensions of Indications 2006 EMEA analysis - Anabela Luis De Lima Marà§al","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/centralised-procedure-analysis-performance-indicators-extensions-indications-2006-emea-analysis-anabela-luis-de-lima-marassal_en.pdf"},
    {"id":"8133","name":"Marshmallow root: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T01:00:00Z","last_updated_date":"2016-12-02T01:00:00Z","reference_number":"EMA/570566/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/marshmallow-root-summary-public_en.pdf"},
    {"id":"8134","name":"Review of hydroxyzine-containing medicines started","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T02:00:00Z","last_updated_date":"2014-05-08T02:00:00Z","reference_number":"EMA/268604/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-hydroxyzine-containing-medicines-started_en.pdf"},
    {"id":"8136","name":"Presentation - PML consortium - industry, Susan Goelz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pml-consortium-industry-susan-goelz_en.pdf"},
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    {"id":"8143","name":"EU/3/17/1830: Public summary of opinion on orphan designation: 5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)pyridin-2-amine for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/80870/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171830-public-summary-opinion-orphan-designation-5-46-dimorpholino-135-triazin-2-yl-4-trifluoromethylpyridin-2-amine-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"8144","name":"How to define high-risk medicinal products? - C Schneider","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/how-define-high-risk-medicinal-products-c-schneider_en.pdf"},
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    {"id":"8148","name":"Committee for Proprietary Medicinal Products (CPMP): meeting of 11 to 13 December 2001","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-12-13T00:09:21Z","last_updated_date":"2001-12-13T00:09:21Z","reference_number":"EMEA/CPMP/4025/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-meeting-11-13-december-2001_en.pdf"},
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    {"id":"8155","name":"Withdrawal letter: Somnena","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-09-14T02:00:00Z","last_updated_date":"2017-09-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-somnena_en.pdf"},
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    {"id":"8163","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:00:00Z","last_updated_date":"2016-08-15T12:00:00Z","reference_number":"EMA/172711/2016","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-product-or-population-specific-considerations-ii-biological-medicinal-products_en.pdf"},
    {"id":"8164","name":"Presentation - Additional monitoring – proposals on the black symbol for the summary of product characteristics and package leaflet (Ana Sempere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-additional-monitoring-proposals-black-symbol-summary-product-characteristics-and-package-leaflet-ana-sempere_en.pdf"},
    {"id":"8166","name":"COMP meeting report on the review of applications for orphan designation: January 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T01:00:00Z","last_updated_date":"2017-02-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-january-2017_en.pdf"},
    {"id":"8169","name":"Outcome of the workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/774690/2014","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-workshop-viral-safety-plasma-derived-medicinal-products-respect-hepatitis-e-virus_en.pdf"},
    {"id":"8170","name":"Opinions on safety variations - Adopted at the CHMP meeting of 17-20 September 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-09-24T10:44:00Z","last_updated_date":"2012-09-24T10:44:00Z","reference_number":"EMA/CHMP/539766/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-chmp-meeting-17-20-september-2012_en.pdf"},
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    {"id":"8172","name":"Presentation - Management of safety data from patient-support programmes and market-research programmes: Overview of legal requirements applicable to marketing-authorisation holders' (Gilles Touraille)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T02:00:00Z","last_updated_date":"2013-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-management-safety-data-patient-support-programmes-and-market-research-programmes-overview-legal-requirements-applicable-marketing-authorisation-holders-gilles-touraille_en.pdf"},
    {"id":"8174","name":"Mandate, objectives and rules of procedure for the CHMP Pharmacovigilance Working Party","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2005-06-23T02:09:21Z","last_updated_date":"2005-06-23T02:09:21Z","reference_number":"EMEA/CHMP/PhVWP/88786/04","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-chmp-pharmacovigilance-working-party_en.pdf"},
    {"id":"8175","name":"Commission Regulation (EU) 2016/461 of 30 March 2016 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T12:30:00Z","last_updated_date":"2016-04-01T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/commission-regulation-eu-2016461-30-march-2016-amending-council-regulation-ec-no-29795-regards-adjustment-fees-european-medicines-agency-inflation-rate_en.pdf"},
    {"id":"8177","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-03-20T15:00:00Z","last_updated_date":"2015-03-20T15:00:00Z","reference_number":"EMA/128095/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-february-2015_en.pdf"},
    {"id":"8178","name":"EU/3/17/1910: Public summary of opinion on orphan designation: Sirolimus for the treatment of tuberous sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/507442/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171910-public-summary-opinion-orphan-designation-sirolimus-treatment-tuberous-sclerosis_en.pdf"},
    {"id":"8180","name":"Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2016-06-08T13:45:00Z","last_updated_date":"2016-06-08T13:45:00Z","reference_number":"EMA/HMPC/328782/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-contamination-herbal-medicinal-productstraditional-herbal-medicinal-products-pyrrolizidine-alkaloids_en.pdf"},
    {"id":"8181","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 October 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-10-14T02:00:00Z","last_updated_date":"2011-10-14T02:00:00Z","reference_number":"EMA/CVMP/790208/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-october-2011_en.pdf"},
    {"id":"8182","name":"Concept paper on dossier requirements for oncology products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-06-15T02:00:00Z","last_updated_date":"2005-06-15T02:00:00Z","reference_number":"EMEA/CVMP/EWP/79590/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-dossier-requirements-oncology-products_en.pdf"},
    {"id":"8183","name":"Presentation - Procedural updates and organisation: Update on variations and progress in work-sharing (Melanie Leivers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedural-updates-and-organisation-update-variations-and-progress-work-sharing-melanie-leivers_en.pdf"},
    {"id":"8186","name":"Final European Union herbal monograph on Ricinus communis L., oleum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-03-01T01:00:00Z","last_updated_date":"2016-03-01T01:00:00Z","reference_number":"EMA/HMPC/572974/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-ricinus-communis-l-oleum_en.pdf"},
    {"id":"8189","name":"Agenda - PRAC draft agenda of meeting 2-5 September 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-09-02T14:50:00Z","last_updated_date":"2013-09-02T14:50:00Z","reference_number":"EMA/PRAC/534993/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-2-5-september-2013_en.pdf"},
    {"id":"8190","name":"CHMP post-authorisation summary of positive opinion for Isentress","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-03-06T12:07:00Z","reference_number":"EMA/CHMP/87645/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-isentress_en.pdf"},
    {"id":"8192","name":"CHMP post-authorisation summary of positive opinion for Baraclude","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/CHMP/56057/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-baraclude_en.pdf"},
    {"id":"8194","name":"Flubendazole (Extension to turkeys): Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/576/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flubendazole-extension-turkeys-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"8197","name":"Workshop - the role of pharmacodynamic and pharmacokinetic measurements in the use of direct oral anticoagulants: Background document","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-20T11:35:00Z","last_updated_date":"2015-11-20T11:35:00Z","reference_number":"EMA/746962/2015","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-role-pharmacodynamic-and-pharmacokinetic-measurements-use-direct-oral-anticoagulants-background-document_en.pdf"},
    {"id":"8201","name":"Presentation - Ethical principles and practices in paediatric trials: emerging issues","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ethical-principles-and-practices-paediatric-trials-emerging-issues_en.pdf"},
    {"id":"8202","name":"EU/3/18/2022: Public summary of opinion on orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment for the treatment of congenital hyperinsulinism","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-24T12:51:00Z","last_updated_date":"2018-07-24T12:51:00Z","reference_number":"EMA/271839/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182022-public-summary-opinion-orphan-designation-glucagon-analogue-linked-human-immunoglobulin-fc-fragment-treatment-congenital-hyperinsulinism_en.pdf"},
    {"id":"8203","name":"Final list of references supporting the assessment of Ricinus communis L., oleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-03-01T01:00:00Z","last_updated_date":"2016-03-01T01:00:00Z","reference_number":"EMA/HMPC/572975/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-ricinus-communis-l-oleum_en.pdf"},
    {"id":"8204","name":"Advanced-therapy medicinal products: Responses to list of questions/supplementary request for information/list of outstanding issues","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-12-06T01:00:00Z","last_updated_date":"2009-12-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/advanced-therapy-medicinal-products-responses-list-questionssupplementary-request-informationlist-outstanding-issues_en.pdf"},
    {"id":"8205","name":"Assessment report for fenofibrate-, bezafibrate-, ciprofibrate- and gemfibrozil-containing medicinal products","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T17:00:00Z","last_updated_date":"2013-04-03T17:00:00Z","reference_number":"EMA/CHMP/580013/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-fenofibrate-bezafibrate-ciprofibrate-and-gemfibrozil-containing-medicinal-products_en.pdf"},
    {"id":"8206","name":"Agenda - Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T16:00:00Z","last_updated_date":"2014-10-07T11:35:00Z","reference_number":"EMA/149595/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-regulatory-workshop-clinical-trials-designs-neuromyelitis-optica-and-spectrum-disorders_en.pdf"},
    {"id":"8207","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  sovrima  International non-proprietary name (INN): idebenone","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:09:21Z","last_updated_date":"2008-07-24T02:09:21Z","reference_number":"EMEA/359839/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-sovrima-international-non-proprietary-name-inn-idebenone_en.pdf"},
    {"id":"8208","name":"Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2016","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T11:17:00Z","last_updated_date":"2017-05-12T11:17:00Z","reference_number":"EMA/826577/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-dialogue-meeting-december-2016_en.pdf"},
    {"id":"8209","name":"Presentation - Industry perspective: Pfizer - Eliquis® (apixaban)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-pfizer-eliquisr-apixaban_en.pdf"},
    {"id":"8212","name":"News bulletin for small and medium-sized enterprises - Issue 41","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2017-11-07T14:47:00Z","last_updated_date":"2017-11-07T14:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-41_en.pdf"},
    {"id":"8215","name":"Extract from the published minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Annex 1","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/670072/2015","document_url":"https://www.ema.europa.eu/en/documents/other/extract-published-minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-annex-1_en.pdf"},
    {"id":"8217","name":"Presentation - Multivariate analysis of treatment in multiple sclerosis using the Wei-Lachin procedure (Thomas Zwingers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multivariate-analysis-treatment-multiple-sclerosis-using-wei-lachin-procedure-thomas-zwingers_en.pdf"},
    {"id":"8218","name":"The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future Outcome of the Consultation with the EMEA’s Partners and Stakeholders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-03-04T01:00:00Z","last_updated_date":"2005-03-04T01:00:00Z","reference_number":"Ref. EMEA/83716/2004/Final","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-road-map-2010-preparing-ground-future-outcome-consultation-emeas-partners-and-stakeholders_en.pdf"},
    {"id":"8221","name":"Overview of Paediatric Investigation Plans in Paediatric Rheumatology, Dr Richard Vesely, Dr Emma Sala Soriano","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-paediatric-investigation-plans-paediatric-rheumatology-dr-richard-vesely-dr-emma-sala-soriano_en.pdf"},
    {"id":"8222","name":"Seasonique Article-29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-01-27T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"EMA/CHMP/24607/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/seasonique-article-294-referral-assessment-report_en.pdf"},
    {"id":"8224","name":"Final list of references supporting the assessment of Calendula officinalis L., flos - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-06-14T15:00:00Z","last_updated_date":"2018-06-14T15:00:00Z","reference_number":"EMA/HMPC/603407/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-calendula-officinalis-l-flos-revision-1_en.pdf"},
    {"id":"8225","name":"EU/3/04/201: Public summary of positive opinion for orphan designation: Vascular endothelial growth factor-D gene in an adenoviral vector for use with a collagen collar for the prevention of stenosis in synthetic grafts ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-12-06T00:00:00Z","last_updated_date":"2014-04-03T16:00:00Z","reference_number":"EMA/COMP/260/04 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304201-public-summary-positive-opinion-orphan-designation-vascular-endothelial-growth-factor-d-gene-adenoviral-vector-use-collagen-collar-prevention-stenosis-synthetic-grafts_en.pdf"},
    {"id":"8226","name":"Chloroquine: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00000685/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-18T15:41:12Z","reference_number":"EMA/344102/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/chloroquine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000685201508_en.pdf"},
    {"id":"8228","name":"Presentation - Medication errors: what patients can do to minimise them (Francois Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medication-errors-what-patients-can-do-minimise-them-francois-houyez_en.pdf"},
    {"id":"8231","name":"EU/3/03/145: Public summary of positive opinion for orphan designation of rubitecan for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-06-23T02:00:00Z","last_updated_date":"2003-06-23T02:00:00Z","reference_number":"EMEA/COMP/1227/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303145-public-summary-positive-opinion-orphan-designation-rubitecan-treatment-pancreatic-cancer_en.pdf"},
    {"id":"8232","name":"Donation of EMA IT assets no. EMA/2016/35/IT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-29T12:45:00Z","last_updated_date":"2016-07-29T12:45:00Z","reference_number":"EMA/263097/2016","document_url":"https://www.ema.europa.eu/en/documents/other/donation-ema-it-assets-no-ema201635it_en.pdf"},
    {"id":"8234","name":"CVMP summary of positive opinion for RevitaCAM","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-12-09T01:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/CVMP/77474/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-revitacam_en.pdf"},
    {"id":"8236","name":"Presentation - Impact of D-E-R information on regulatory approval and post-authorisation commitments: FDA perspective (Yaning Wang, Vikram Sinha)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-d-e-r-information-regulatory-approval-and-post-authorisation-commitments-fda-perspective-yaning-wang-vikram-sinha_en.pdf"},
    {"id":"8237","name":"Carprofen: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-11-01T01:00:00Z","last_updated_date":"2004-11-01T01:00:00Z","reference_number":"EMEA/MRL/914/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/carprofen-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"8238","name":"Presentation - eSubmissions update (Dorota Stark)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-esubmissions-update-dorota-stark_en.pdf"},
    {"id":"8240","name":"Human medicines highlights - March 2012","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2012-04-04T13:45:00Z","last_updated_date":"2012-04-04T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-march-2012_en.pdf"},
    {"id":"8241","name":"Aclasta: Product Information as approved by the CHMP on 26 March 2015, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T13:00:00Z","last_updated_date":"2015-03-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/aclasta-product-information-approved-chmp-26-march-2015-pending-endorsement-european-commission_en.pdf"},
    {"id":"8243","name":"VICH GL11: Impurities in new veterinary medicinal products  - Step 7 (after revision at step 9)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-02-19T01:00:00Z","last_updated_date":"2007-02-19T01:00:00Z","reference_number":"EMEA/CVMP/VICH/838/99-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl11-impurities-new-veterinary-medicinal-products-step-7-after-revision-step-9_en.pdf"},
    {"id":"8245","name":"Revised position paper on indications for veterinary vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-06-20T02:09:21Z","last_updated_date":"2003-06-20T02:09:21Z","reference_number":"EMEA/CVMP/042/97-Rev.1-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-position-paper-indications-veterinary-vaccines_en.pdf"},
    {"id":"8246","name":"Novimp - Article 36 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"EMEA/H/A-36/1298","document_url":"https://www.ema.europa.eu/en/documents/referral/novimp-article-36-referral-assessment-report_en.pdf"},
    {"id":"8247","name":"EudraVigilance - National competent authorities - Adobe connect invitation","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2018-02-14T14:00:00Z","reference_number":"EMA/381965/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-national-competent-authorities-adobe-connect-invitation_en.pdf"},
    {"id":"8248","name":"Withdrawal assessment report for Aivlosin: Extension (new target species)","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-21T18:00:00Z","last_updated_date":"2014-07-21T18:00:00Z","reference_number":"EMA/CVMP/12822/2014","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-aivlosin-extension-new-target-species_en.pdf"},
    {"id":"8249","name":"Clarification note on the requirements for the starting materials of biological origin","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-09-22T02:09:21Z","last_updated_date":"2008-09-22T02:09:21Z","reference_number":"EMEA/CVMP/439633/2007","document_url":"https://www.ema.europa.eu/en/documents/other/clarification-note-requirements-starting-materials-biological-origin_en.pdf"},
    {"id":"8252","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 February2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-02-11T01:00:00Z","last_updated_date":"2011-02-11T01:00:00Z","reference_number":"EMA/CVMP/61158/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-february2011_en.pdf"},
    {"id":"8253","name":"Presentation - An overview of EUEC initiatives targeting SMEs (Laszlo Helmle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-euec-initiatives-targeting-smes-laszlo-helmle_en.pdf"},
    {"id":"8254","name":"Guideline on data requirements for changes to the strain composition of authorised equine influenza vaccines in line with World Organisation for Animal Health (OIE) recommendations","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-11-19T12:00:00Z","last_updated_date":"2014-11-19T12:00:00Z","reference_number":"EMA/CVMP/IWP/97961/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-changes-strain-composition-authorised-equine-influenza-vaccines-line-world-organisation-animal-health-oie-recommendations_en.pdf"},
    {"id":"8255","name":"Overview of comments on draft guideline on non-clinical and clinical development of medicinal products for the treatment of nausea and vomiting associated with cancer chemotherapy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-12-14T00:09:21Z","last_updated_date":"2006-12-14T00:09:21Z","reference_number":"EMEA/CHMP/EWP/487732/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-draft-guideline-non-clinical-and-clinical-development-medicinal-products-treatment-nausea-and-vomiting-associated-cancer-chemotherapy_en.pdf"},
    {"id":"8256","name":"Presentation - The role of PSURs in pharmacovigilance inspections –Getting it right and practical experience (Sue Rees)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-psurs-pharmacovigilance-inspections-getting-it-right-and-practical-experience-sue-rees_en.pdf"},
    {"id":"8257","name":"Benefit-risk methodology project - Report on risk perception study module","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-02-23T10:35:00Z","last_updated_date":"2012-02-23T10:35:00Z","reference_number":"EMA/662299/2011","document_url":"https://www.ema.europa.eu/en/documents/report/benefit-risk-methodology-project-report-risk-perception-study-module_en.pdf"},
    {"id":"8261","name":"Procedure: 2nd step of the Plasma Master File (PMF) certification procedure for the centrally authorised medicinal products","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-15T01:00:00Z","last_updated_date":"2009-01-15T01:00:00Z","reference_number":"EMEA/CHMP/BWP/373464/2005/Rev 01","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-2nd-step-plasma-master-file-pmf-certification-procedure-centrally-authorised-medicinal-products_en.pdf"},
    {"id":"8263","name":"EU/3/12/1042: Public summary of opinion on orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for the prevention of cytomegalovirus disease in patient...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-26T16:30:00Z","last_updated_date":"2013-06-25T02:00:00Z","reference_number":"EMA/COMP/524463/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121042-public-summary-opinion-orphan-designation-covalently-closed-dna-plasmids-coding-cytomegalovirus-phosphoprotein-65-and-glycoprotein-b-genes-prevention-cytomegalovirus-disease-patient_en.pdf"},
    {"id":"8265","name":"Presentation - Committee for Advanced Therapies feedback (Kieran Breen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-committee-advanced-therapies-feedback-kieran-breen-ema_en.pdf"},
    {"id":"8266","name":"EU/3/14/1388: Public summary of positive opinion for orphan designation: Allogeneic bone marrow derived mesenchymal cells expanded ex vivo in synthetic media for the prevention of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/732370/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141388-public-summary-positive-opinion-orphan-designation-allogeneic-bone-marrow-derived-mesenchymal-cells-expanded-ex-vivo-synthetic-media-prevention-graft-versus-host-disease_en.pdf"},
    {"id":"8267","name":"European Medicines Agency recommends suspension of classical swine fever vaccine Porcilis Pesti","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-12-12T01:00:00Z","last_updated_date":"2008-12-12T01:00:00Z","reference_number":"EMEA/493767/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-classical-swine-fever-vaccine-porcilis-pesti_en.pdf"},
    {"id":"8268","name":"Presentation - Patient perspective after three years of PRAC (A. Van der Zeijden)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-29T18:30:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-perspective-after-three-years-prac-van-der-zeijden_en.pdf"},
    {"id":"8270","name":"EU/3/10/748: Public summary of positive opinion for Pravastatin / zoledronic acid for the treatment of Hutchinson-Gilford progeria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMA/COMP/165397/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310748-public-summary-positive-opinion-pravastatin-zoledronic-acid-treatment-hutchinson-gilford-progeria_en.pdf"},
    {"id":"8272","name":"Presentation - Management of safety data from patient-support programmes (PSPs) and market-research programmes (MRPs) (Gilles Touraille)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T17:00:00Z","last_updated_date":"2013-07-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-management-safety-data-patient-support-programmes-psps-and-market-research-programmes-mrps-gilles-touraille_en.pdf"},
    {"id":"8273","name":"EU/3/06/354: Public summary of positive opinion for orphan designation of Oxalobacter formigenes strain HC-1 for the treatment of primary hyperoxaluria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2013-06-26T02:00:00Z","reference_number":"EMA/COMP/24465/2006 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306354-public-summary-positive-opinion-orphan-designation-oxalobacter-formigenes-strain-hc-1-treatment-primary-hyperoxaluria_en.pdf"},
    {"id":"8276","name":"Public Statement on Infliximab (Remicade) - Increased incidence of mortality and hospitalisation for worsening Congestive Heart Failure","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2001-10-24T02:00:00Z","last_updated_date":"2001-10-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-infliximab-remicade-increased-incidence-mortality-and-hospitalisation-worsening-congestive-heart-failure_en.pdf"},
    {"id":"8278","name":"Examples of prevalence sources previously considered in orphan medicinal product designation procedures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-18T11:40:00Z","last_updated_date":"2014-12-18T11:40:00Z","reference_number":"EMA/765701/2014","document_url":"https://www.ema.europa.eu/en/documents/other/examples-prevalence-sources-previously-considered-orphan-medicinal-product-designation-procedures_en.pdf"},
    {"id":"8279","name":"Start of community reviews - CHMP meeting of 29 March - 1 April 2016","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/227635/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-29-march-1-april-2016_en.pdf"},
    {"id":"8282","name":"Agenda - Schmallenberg workshop at the European Medicines Agency","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2012-03-22T12:30:00Z","last_updated_date":"2012-03-22T12:30:00Z","reference_number":"EMA/CVMP/IWP/180422/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-schmallenberg-workshop-european-medicines-agency_en.pdf"},
    {"id":"8284","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cholic acid FGK (cholic acid) for the treatment of inborn errors in primary bile acid synthesis responsive to treatment with ch...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMA/COMP/777596/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-cholic-acid-fgk-cholic-acid-treatment-inborn-errors-primary-bile-acid-synthesis-responsive-treatment-ch_en.pdf"},
    {"id":"8285","name":"Withdrawal of the marketing authorisation for the medicinal product \"EchoGen - dodecafluoropentane\" EU/1/98/072/001","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2001-05-22T02:00:00Z","last_updated_date":"2001-05-22T02:00:00Z","reference_number":"EMEA/37043/00","document_url":"https://www.ema.europa.eu/en/documents/public-statement/withdrawal-marketing-authorisation-medicinal-product-echogen-dodecafluoropentane-eu198072001_en.pdf"},
    {"id":"8288","name":"EU/3/12/1038: Public summary of opinion on orphan designation: Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-27T16:00:00Z","last_updated_date":"2012-09-27T16:00:00Z","reference_number":"EMA/COMP/509830/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121038-public-summary-opinion-orphan-designation-recombinant-anti-cd3-bi-single-chain-fv-diphtheria-toxin-fusion-protein-treatment-peripheral-t-cell-lymphoma-nodal-other-extranodal-and-leukaemi_en.pdf"},
    {"id":"8291","name":"Committee for medicinal products for veterinary use: Meeting of 6 to 7 September 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-09-08T14:39:21Z","last_updated_date":"2004-09-08T14:39:21Z","reference_number":"EMEA/CVMP/834/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-6-7-september-2004_en.pdf"},
    {"id":"8292","name":"Ergot derivatives Article-31 referral - Nicergoline - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-nicergoline-annex-iv_sv.pdf"}},
    {"id":"8294","name":"Presentation - EMA Working Groups on Committees' Operational Preparedness (M. Dias, A. Humphreys, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-10T02:00:00Z","last_updated_date":"2017-10-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-working-groups-committees-operational-preparedness-m-dias-humphreys-ema_en.pdf"},
    {"id":"8297","name":"Presentation - European haemophilia safety surveillance (EUHASS) (Mike Makris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-haemophilia-safety-surveillance-euhass-mike-makris_en.pdf"},
    {"id":"8298","name":"Public Statement on the allergenic potency of herbal medicinal products containing soya or peanut protein","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-01-12T01:00:00Z","last_updated_date":"2006-01-12T01:00:00Z","reference_number":"EMEA/HMPC/138139/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-allergenic-potency-herbal-medicinal-products-containing-soya-or-peanut-protein_en.pdf"},
    {"id":"8299","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T18:00:00Z","last_updated_date":"2012-12-14T18:00:00Z","reference_number":"EMA/CAT/798213/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-december-2012-meeting_en.pdf"},
    {"id":"8300","name":"COMP meeting report on the review of applications for orphan designation: January 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-02-05T15:50:00Z","last_updated_date":"2018-02-05T15:50:00Z","reference_number":"EMA/COMP/831897/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-january-2018_en.pdf"},
    {"id":"8301","name":"Breakout Workgroup 1 - Organization and Communications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/breakout-workgroup-1-organization-and-communications_en.pdf"},
    {"id":"8302","name":"Hemoprostol : EPAR - Procedural steps taken and scientific information after authorisation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-08T02:00:00Z","last_updated_date":"2015-07-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/hemoprostol-epar-procedural-steps-taken-and-scientific-information-after-authorisation_en.pdf"},
    {"id":"8311","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n23-26 April 2007","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2007-04-27T02:09:21Z","last_updated_date":"2007-04-27T02:09:21Z","reference_number":"EMEA/186566/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-23-26-april-2007_en.pdf"},
    {"id":"8312","name":"EU/3/17/1874: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-29T02:00:00Z","last_updated_date":"2017-06-29T02:00:00Z","reference_number":"EMA/260421/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171874-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-6-encoding-b-domain-deleted-human-factor-viii-treatment-haemophilia_en.pdf"},
    {"id":"8313","name":"Presentation - Take home messages (June Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-take-home-messages-june-raine_en.pdf"},
    {"id":"8315","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:00Z","last_updated_date":"2023-01-23T08:23:00Z","reference_number":"EMA/136156/2012 Rev. 64","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-organisations_en.xls"},
    {"id":"8316","name":"Questions and answers on the referral for Uman Big Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-03-10T00:08:21Z","last_updated_date":"2009-03-10T00:08:21Z","reference_number":"EMEA/CHMP/173455/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-uman-big-human-hepatitis-b-immunoglobulins-180-iuml-solution-injection_sv.pdf"}},
    {"id":"8317","name":"Validation issues frequently seen with initial marketing authorisation holders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T18:30:00Z","last_updated_date":"2020-08-10T11:00:00Z","reference_number":"EMA/454165/2015 Rev. 1.1","document_url":"https://www.ema.europa.eu/en/documents/other/validation-issues-frequently-seen-initial-marketing-authorisation-holders_en.pdf"},
    {"id":"8318","name":"Presentation - Proposed amendment to the policy on transparency and handling of potential conflicts of interests (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposed-amendment-policy-transparency-and-handling-potential-conflicts-interests-irmgard-eichler_en.pdf"},
    {"id":"8319","name":"Presentation - Introduction to SPOR data services","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-16T11:35:00Z","last_updated_date":"2016-08-16T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-spor-data-services_en.pdf"},
    {"id":"8321","name":"CHMP post-authorisation summary of positive opinion for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/CHMP/332974/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-biologicals_en.pdf"},
    {"id":"8322","name":"Presentation - Report from conference \"Shortages of human medicines in the European Union\" (F. Houà¿ez, EURORDIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-report-conference-shortages-human-medicines-european-union-f-houaez-eurordis_en.pdf"},
    {"id":"8323","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Prozac and associated names International Non-Proprietary Name (INN): fluoxetine: Background inform...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-06-18T02:08:21Z","last_updated_date":"2003-06-18T02:08:21Z","reference_number":"EMEA/CPMP/3263/03","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-prozac-and-associated-names-international-non-proprietary-name-inn-fluoxetine-background_en.pdf"},
    {"id":"8324","name":"Guidelines and concept papers adopted during the CHMP meeting 23-26 June 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-07-01T16:30:00Z","last_updated_date":"2014-07-01T16:30:00Z","reference_number":"EMA/125330/2014","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-23-26-june-2014_en.pdf"},
    {"id":"8325","name":"Glycopyrronium / neostigmine: List of nationally authorised medicinal products - PSUSA/00001557/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-10-17T15:45:54Z","reference_number":"EMA/471844/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/glycopyrronium-neostigmine-list-nationally-authorised-medicinal-products-psusa00001557201509_en.pdf"},
    {"id":"8326","name":"Public bulletin: Veterinary pharmacovigilance 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-01T01:00:00Z","last_updated_date":"2011-03-01T01:00:00Z","reference_number":"EMA/CVMP/PhVWP/44873/2011","document_url":"https://www.ema.europa.eu/en/documents/other/public-bulletin-veterinary-pharmacovigilance-2010_en.pdf"},
    {"id":"8328","name":"Agenda - Extraordinary Management Board meeting for the building approval process of European Medicines Agency premises in Amsterdam (in-camera): 28 February 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-02-28T11:00:00Z","last_updated_date":"2018-02-28T11:00:00Z","reference_number":"EMA/MB/102050/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-extraordinary-management-board-meeting-building-approval-process-european-medicines-agency-premises-amsterdam-camera-28-february-2018_en.pdf"},
    {"id":"8329","name":"Committee for Medicinal Products for Human Use (CHMP) -  September 2006 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-09-29T02:00:00Z","last_updated_date":"2006-09-29T02:00:00Z","reference_number":"EMEA/325128/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-september-2006-plenary-meeting-monthly-report_en.pdf"},
    {"id":"8330","name":"Standard operating procedure on handling of European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal applications","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"SOP/H/3362","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-handling-european-network-centres-pharmacoepidemiology-and-pharmacovigilance-encepp-study-seal-applications_en.pdf"},
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    {"id":"8335","name":"Wyeth Europa Ltd withdraws its marketing authorisation application for Ellefore","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-15T02:09:21Z","last_updated_date":"2008-10-15T02:09:21Z","reference_number":"EMEA/542142/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/wyeth-europa-ltd-withdraws-its-marketing-authorisation-application-ellefore_en.pdf"},
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    {"id":"8352","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vienna, October 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-06-14T17:00:00Z","last_updated_date":"2018-06-14T17:00:00Z","reference_number":"Course # 18517","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-vienna-october-2018_en.pdf"},
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    {"id":"8365","name":"Final Community herbal monograph on Passiflora incarnata L., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-06-18T12:05:00Z","last_updated_date":"2014-06-18T12:05:00Z","reference_number":"EMA/HMPC/669740/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-passiflora-incarnata-l-herba_en.pdf"},
    {"id":"8366","name":"Public statement on Clopidogrel Acino Pharma GmbH: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-07-26T02:00:00Z","last_updated_date":"2012-07-26T02:00:00Z","reference_number":"EMA/328312/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-acino-pharma-gmbh-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"8369","name":"EU/3/07/430: Public summary of positive opinion for orphan designation of artesunate for the treatment of malaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2008-07-10T02:00:00Z","reference_number":"EMEA/COMP/96483/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307430-public-summary-positive-opinion-orphan-designation-artesunate-treatment-malaria_en.pdf"},
    {"id":"8371","name":"EU/3/14/1330: Public summary of opinion on orphan designation: Lentiviral vector containing the human liver and erythroid pyruvate kinase (PKLR) gene for the treatment of pyruvate kinase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/436864/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141330-public-summary-opinion-orphan-designation-lentiviral-vector-containing-human-liver-and-erythroid-pyruvate-kinase-pklr-gene-treatment-pyruvate-kinase-deficiency_en.pdf"},
    {"id":"8373","name":"Reporting requirements of marketing authorisation holders in the European Union (EU) regarding suspected adverse reactions occurring with medicinal products they donate outside the EU to public health programmes against ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-27T13:03:00Z","last_updated_date":"2015-04-27T13:03:00Z","reference_number":"EMA/182873/2015","document_url":"https://www.ema.europa.eu/en/documents/other/reporting-requirements-marketing-authorisation-holders-european-union-eu-regarding-suspected-adverse-reactions-occurring-medicinal-products-they-donate-outside-eu-public-health-programmes-against_en.pdf"},
    {"id":"8375","name":"The Committee for Advanced Therapies (CAT) - Lucia D'Apote","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/committee-advanced-therapies-cat-lucia-dapote_en.pdf"},
    {"id":"8376","name":"Agenda - PRAC draft agenda of meeting 14-17 May 2018","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-05-14T17:30:00Z","last_updated_date":"2018-05-14T17:30:00Z","reference_number":"EMA/292387/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-14-17-may-2018_en.pdf"},
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    {"id":"8416","name":"Listening to the public’s views on the safety of medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-15T14:00:00Z","last_updated_date":"2016-04-15T14:00:00Z","reference_number":"EMA/262673/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/listening-publics-views-safety-medicines_en.pdf"},
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    {"id":"8426","name":"Manganese carbonate (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-12T12:33:00Z","last_updated_date":"2013-11-12T12:33:00Z","reference_number":"EMA/CVMP/685072/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/manganese-carbonate-all-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"8427","name":"European Medicines Agency pandemic-influenza crisis management plan for the evaluation and maintenance of pandemic-influenza vaccines and antivirals","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-08-21T02:09:21Z","last_updated_date":"2006-08-21T02:09:21Z","reference_number":"EMEA/214301/2006","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-pandemic-influenza-crisis-management-plan-evaluation-and-maintenance-pandemic-influenza-vaccines-and-antivirals_en.pdf"},
    {"id":"8432","name":"Notes on a seminar involving the European Federation of Pharmaceutical Industries and Associations and the European Medicines Agency process-analytical-technology team in Ireland, 31 March - 2 April 2008","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-10-28T01:00:00Z","last_updated_date":"2008-10-28T01:00:00Z","reference_number":"EMEA/INS/575495/2008","document_url":"https://www.ema.europa.eu/en/documents/other/notes-seminar-involving-european-federation-pharmaceutical-industries-and-associations-and-european-medicines-agency-process-analytical-technology-team-ireland-31-march-2-april-2008_en.pdf"},
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    {"id":"8436","name":"Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-03-20T13:30:00Z","last_updated_date":"2012-03-20T13:30:00Z","reference_number":"EMA/INS/GCP/532137/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-laboratories-perform-analysis-or-evaluation-clinical-trial-samples_en.pdf"},
    {"id":"8438","name":"Levamisole: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/levamisole-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"8499","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - April 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-04-30T02:00:00Z","last_updated_date":"2008-04-30T02:00:00Z","reference_number":"EMEA/241937/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-april-2008_en.pdf"},
    {"id":"8503","name":"CHMP post-authorisation summary of positive opinion for Xgeva (II-55)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-02-23T13:00:00Z","last_updated_date":"2018-02-23T13:00:00Z","reference_number":"EMA/86370/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xgeva-ii-55_en.pdf"},
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    {"id":"8507","name":"Final European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-05-23T12:50:00Z","last_updated_date":"2016-05-23T12:50:00Z","reference_number":"EMA/HMPC/41108/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-helichrysum-arenarium-l-moench-flos_en.pdf"},
    {"id":"8509","name":"EU/3/17/1846: Public summary of opinion on orphan designation: Vemurafenib for the treatment of Erdheim-Chester disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/72440/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171846-public-summary-opinion-orphan-designation-vemurafenib-treatment-erdheim-chester-disease_en.pdf"},
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    {"id":"8515","name":"Cefazolin: List of nationally authorised medicinal products - PSUSA/00000589/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-07T14:00:00Z","last_updated_date":"2017-09-07T14:00:00Z","reference_number":"EMA/590591/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefazolin-list-nationally-authorised-medicinal-products-psusa00000589201611_en.pdf"},
    {"id":"8518","name":"Letter of invitation to tender - Provision of training courses for EMA staff (Lots 1-6)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-03T01:00:00Z","last_updated_date":"2012-01-03T01:00:00Z","reference_number":"EMA/974043/2011","document_url":"https://www.ema.europa.eu/en/documents/other/letter-invitation-tender-provision-training-courses-ema-staff-lots-1-6_en.pdf"},
    {"id":"8522","name":"Presentation - Developing drugs for the treatment of Alzheimer’s disease (Eric Bastings, Billy Dunn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-developing-drugs-treatment-alzheimers-disease-eric-bastings-billy-dunn_en.pdf"},
    {"id":"8523","name":"Draft concept paper on similar biological medicinal products containing low molecular weight heparins1 - (non) clinical issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"EMEA/CHMP/BMWP/496286/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-similar-biological-medicinal-products-containing-low-molecular-weight-heparins1-non-clinical-issues_en.pdf"},
    {"id":"8528","name":"EU/3/13/1234: Public summary of opinion on orphan designation: N-(3-(5-fluoro-2-(4-(2-methoxyethoxy)phenylamino)pyrimidin-4-ylamino)phenyl)acrylamide benzenesulfonic acid salt for the treatment of chronic lymphocytic leu...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMA/COMP/9979/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131234-public-summary-opinion-orphan-designation-n-3-5-fluoro-2-4-2-methoxyethoxyphenylaminopyrimidin-4-ylaminophenylacrylamide-benzenesulfonic-acid-salt-treatment-chronic-lymphocytic-leu_en.pdf"},
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    {"id":"8531","name":"EU/3/16/1670: Public summary of opinion on orphan designation: Vemurafenib for treatment of Langerhans’ cell histiocytosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-22T02:00:00Z","last_updated_date":"2016-06-22T02:00:00Z","reference_number":"EMA/COMP/313647/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161670-public-summary-opinion-orphan-designation-vemurafenib-treatment-langerhans-cell-histiocytosis_en.pdf"},
    {"id":"8534","name":"Divergent position on a CVMP opinion on an Article-13 referral of Directive 2001/82/EC for Soludox 500-mg/g powder for use in drinking water for pigs","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-09-24T02:00:00Z","last_updated_date":"2013-09-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-13-referral-directive-200182ec-soludox-500-mgg-powder-use-drinking-water-pigs_en.pdf"},
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    {"id":"8537","name":"Guidelines and concept papers adopted during the CHMP meeting 20-23 June 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-06-30T18:00:00Z","last_updated_date":"2016-06-30T18:00:00Z","reference_number":"EMA/76607/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-20-23-june-2016_en.pdf"},
    {"id":"8541","name":"Questions and answers on the withdrawal of the marketing authorisation application for Ibandronic Acid Hexal","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-08-22T02:00:00Z","last_updated_date":"2011-08-22T02:00:00Z","reference_number":"EMA/685524/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ibandronic-acid-hexal_sv.pdf"}},
    {"id":"8542","name":"PDCO meeting highlights 1-2 August 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-08-06T02:00:00Z","last_updated_date":"2007-08-06T02:00:00Z","reference_number":"EMEA/354317/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-1-2-august-2007_en.pdf"},
    {"id":"8544","name":"EU/3/10/729: Public summary of opinion on orphan designation: (1S, 2S, 3R, 4R)-3-(5-Fluoro-2-(3-methyl-4-(4-methylpiperazin-1-yl)-phenylamino)-pyrimidin-4-ylamino)-bicyclo[2.2.1]hept-5-ene-2-carboxamide benzoate for the ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2011-11-18T12:16:00Z","reference_number":"EMA/COMP/23533/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310729-public-summary-opinion-orphan-designation-1s-2s-3r-4r-3-5-fluoro-2-3-methyl-4-4-methylpiperazin-1-yl-phenylamino-pyrimidin-4-ylamino-bicyclo221hept-5-ene-2-carboxamide-benzoate_en.pdf"},
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    {"id":"8547","name":"EU/3/11/911: Public summary of opinion on orphan designation: Recombinant human galactocerebrosidase for the treatment of globoid cell leukodystrophy (Krabbe disease)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2020-08-12T02:00:00Z","reference_number":"EMA/COMP/584544/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311911-public-summary-opinion-orphan-designation-recombinant-human-galactocerebrosidase-treatment-globoid-cell-leukodystrophy-krabbe-disease_en.pdf"},
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    {"id":"8549","name":"EU/3/16/1735 : Public summary of opinion on orphan designation: Zoledronic acid for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161735-public-summary-opinion-orphan-designation-zoledronic-acid-treatment-glioma_en.pdf"},
    {"id":"8550","name":"Overview of comments received on the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg): (EMA/CHMP/BPWP/94033/2007, rev. 2 formerly CPMP/BPWG/388/95 rev. 2)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-08-02T02:00:00Z","last_updated_date":"2010-08-02T02:00:00Z","reference_number":"EMA/CHMP/BPWP/604687/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-emachmpbpwp940332007-rev-2-formerly-cpmpbpwg38895-rev-2_en.pdf"},
    {"id":"8554","name":"Zykadia recommended for approval in advanced non small cell lung cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/133576/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/zykadia-recommended-approval-advanced-non-small-cell-lung-cancer_en.pdf"},
    {"id":"8555","name":"European Medicines Agency recommends suspension of marketing authorisation for sibutramine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-21T01:00:00Z","last_updated_date":"2010-01-21T01:00:00Z","reference_number":"EMA/39408/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-marketing-authorisation-sibutramine_en.pdf"},
    {"id":"8556","name":"Presentation - Status update of changes to the operations in the centralised procedure (Evdokia Korakianiti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T02:00:00Z","last_updated_date":"2015-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-status-update-changes-operations-centralised-procedure-evdokia-korakianiti_en.pdf"},
    {"id":"8557","name":"Summary of transfers of appropriations in budget 2016 - Period 29 November 2016 to 13 December 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-03-17T17:00:00Z","last_updated_date":"2017-03-17T17:00:00Z","reference_number":"EMA/124297/2017","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2016-period-29-november-2016-13-december-2016_en.pdf"},
    {"id":"8558","name":"Presentation - Accession preparation - Phasing-in","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accession-preparation-phasing_en.pdf"},
    {"id":"8559","name":"Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-03-27T16:45:00Z","last_updated_date":"2015-03-27T16:45:00Z","reference_number":"EMA/CHMP/SWP/620008/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-iron-based-nano-colloidal-products-developed-reference-innovator-medicinal-product_en.pdf"},
    {"id":"8560","name":"Polyethylene glycols (including polyethylene glycol 200, polyethylene glycol 300, polyethylene glycol 400, polyethylene glycol 600, polyethylene glycol 1000, polyethylene glycol 1500, polyethylene glycol 1540, polyethyle...","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/034/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/polyethylene-glycols-including-polyethylene-glycol-200-polyethylene-glycol-300-polyethylene-glycol-400-polyethylene-glycol-600-polyethylene-glycol-1000-polyethylene-glycol-1500-polyethylene-glycol_en.pdf"},
    {"id":"8564","name":"Technical specification - Annex 6 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"EMA/193130/2012","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-6-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"8566","name":"Committee on herbal medicinal products (HMPC): Meeting report, 5-6 March 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-03-27T00:00:00Z","last_updated_date":"2008-03-27T00:00:00Z","reference_number":"EMEA/HMPC/144374/200","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-5-6-march-2008_en.pdf"},
    {"id":"8567","name":"Presentation - Modelling to support Benefit/Risk assessment – Will it enhance our capability and improve transparency?, Dr Phillips","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-support-benefitrisk-assessment-will-it-enhance-our-capability-and-improve-transparency-dr-phillips_en.pdf"},
    {"id":"8568","name":"Superseded assessment report on Plantago ovate Forssk., seminis tegumentum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMEA/HMPC/165838/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-plantago-ovate-forssk-seminis-tegumentum_en.pdf"},
    {"id":"8569","name":"Granisetron: List of nationally authorised medicinal products -PSUSA/00001568/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-22T12:00:00Z","last_updated_date":"2016-12-22T12:00:00Z","reference_number":"EMA/398898/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/granisetron-list-nationally-authorised-medicinal-products-psusa00001568201602_en.pdf"},
    {"id":"8570","name":"Technical specification - Annex 9 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-9-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"8571","name":"Opinions on safety variations/PSURs adopted at the CHMP meeting 21-24 October 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T17:30:00Z","last_updated_date":"2013-10-29T17:30:00Z","reference_number":"EMA/634287/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variationspsurs-adopted-chmp-meeting-21-24-october-2013_en.pdf"},
    {"id":"8574","name":"Start of community reviews - CHMP meeting of 21-24 September 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/609858/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-21-24-september-2015_en.pdf"},
    {"id":"8575","name":"Invitation to EMEA 10th anniversary celebrations 11 March 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-03-02T00:09:21Z","last_updated_date":"2005-03-02T00:09:21Z","reference_number":"EMEA/50135/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/invitation-emea-10th-anniversary-celebrations-11-march-2005_en.pdf"},
    {"id":"8580","name":"Presentation - Update on implementation of the clinical trial regulation (A. M. Janson Lang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-implementation-clinical-trial-regulation-m-janson-lang_en.pdf"},
    {"id":"8581","name":"Chloroform (all mammalian food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-02-26T12:30:00Z","last_updated_date":"2014-02-26T12:30:00Z","reference_number":"EMA/CVMP/350579/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/chloroform-all-mammalian-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"8582","name":"Superseded community herbal monograph on Ruscus aculeatus L, rhizome","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2019-05-02T17:00:00Z","reference_number":"EMEA/HMPC/261938/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-ruscus-aculeatus-l-rhizome_en.pdf"},
    {"id":"8586","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 19–22 June 2017","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2017-06-23T14:00:00Z","last_updated_date":"2017-06-23T14:00:00Z","reference_number":"EMA/CHMP/SAWP/395099/2017","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-19-22-june-2017_en.pdf"},
    {"id":"8588","name":"EudraVigilance to support EU Pharmacovigilance Activities - Thomas Goedecke","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eudravigilance-support-eu-pharmacovigilance-activities-thomas-goedecke_en.pdf"},
    {"id":"8593","name":"List of references supporting the assessment report on: Polypodii rhizoma Polypodium vulgare L., rhizoma (polypody rhizome)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/600670/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-report-polypodii-rhizoma-polypodium-vulgare-l-rhizoma-polypody-rhizome_en.pdf"},
    {"id":"8594","name":"Opinion following an article 35 referral for Micotil 300 and its associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-12T02:00:00Z","last_updated_date":"2014-08-12T02:00:00Z","reference_number":"EMA/250814/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-35-referral-micotil-300-and-its-associated-names_en.pdf"},
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    {"id":"8601","name":"EU/3/15/1484: Public summary of positive opinion for orphan designation of Nitric oxide for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T14:00:00Z","last_updated_date":"2015-05-22T14:00:00Z","reference_number":"EMA/COMP/207860/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151484-public-summary-positive-opinion-orphan-designation-nitric-oxide-treatment-cystic-fibrosis_en.pdf"},
    {"id":"8602","name":"Withdrawal assessment report for Retaane","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2006-03-30T02:00:00Z","last_updated_date":"2006-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-retaane_en.pdf"},
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    {"id":"8604","name":"EU/3/04/211: Public summary of positive opinion for orphan designation of defibrotide for the prevention of hepatic veno-occlusive disease (VOD)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2005-12-12T00:00:00Z","reference_number":"EMEA/COMP/312/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304211-public-summary-positive-opinion-orphan-designation-defibrotide-prevention-hepatic-veno-occlusive-disease-vod_en.pdf"},
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    {"id":"8613","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 23–26 March 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-03-27T13:00:00Z","last_updated_date":"2015-03-27T13:00:00Z","reference_number":"EMA/CHMP/SAWP/210613/20155","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-23-26-march-2015_en.pdf"},
    {"id":"8614","name":"Superseded community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMEA/HMPC/251323/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"8615","name":"EU/3/05/315: Public summary of positive opinion for orphan designationof (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl] butanamidefor the treatment of progressive myoclonic epilepsies","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2022-11-08T02:00:00Z","reference_number":"EMEA/COMP/247530/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305315-public-summary-positive-opinion-orphan-designationof-2s-2-4r-2-oxo-4-propyltetrahydro-1h-pyrrol-1-yl-butanamidefor-treatment-progressive-myoclonic-epilepsies_en.pdf"},
    {"id":"8616","name":"Alcover Article-29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-01-12T01:00:00Z","last_updated_date":"2018-01-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/alcover-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/alcover-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/alcover-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/alcover-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/alcover-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/alcover-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/alcover-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/alcover-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/alcover-article-294-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/alcover-article-294-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/alcover-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/alcover-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/alcover-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/alcover-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/alcover-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/alcover-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/alcover-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/alcover-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/alcover-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/alcover-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/alcover-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/alcover-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/alcover-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"8620","name":"CHMP summary of positive opinion for Removab","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2017-07-12T02:00:00Z","reference_number":"EMEA/CHMP/100097/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-removab_en.pdf"},
    {"id":"8621","name":"We work together to fight antibiotic resistance keeping Europeans healthy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T11:00:00Z","last_updated_date":"2017-11-13T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/we-work-together-fight-antibiotic-resistance-keeping-europeans-healthy_en.pdf"},
    {"id":"8622","name":"Discussion paper: The European Medicines Agency Road Map to 2010: Preparing the ground for the future: Executive Summary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-03-23T01:00:00Z","last_updated_date":"2004-03-23T01:00:00Z","reference_number":"EMEA/H/34163/03/Rev 2.0","document_url":"https://www.ema.europa.eu/en/documents/other/discussion-paper-european-medicines-agency-road-map-2010-preparing-ground-future-executive-summary_en.pdf"},
    {"id":"8624","name":"Presentation - Procedure for election of HCPWP Co-Chair","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedure-election-hcpwp-co-chair_en.pdf"},
    {"id":"8625","name":"Hydrochlorothiazide, spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T01:00:00Z","last_updated_date":"2016-10-17T17:35:14Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-spironolactone-list-nationally-authorised-medicinal-products-psusa00001662201501_en.pdf"},
    {"id":"8629","name":"Combined hormonal contraceptives: Article-31 referral - Review started","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T13:00:00Z","last_updated_date":"2013-02-08T13:00:00Z","reference_number":"EMA/75551/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-review-started_en.pdf"},
    {"id":"8630","name":"CHMP post-authorisation summary of positive opinion for Tresiba","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-12-19T01:00:00Z","last_updated_date":"2014-12-19T01:00:00Z","reference_number":"EMA/CHMP/745432/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tresiba_en.pdf"},
    {"id":"8634","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the sixty-ninth meeting of the committee for veterinary medicinal products took place in London on 11-13 September 2001.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-09-13T14:39:21Z","last_updated_date":"2001-09-13T14:39:21Z","reference_number":"EMEA/CVMP/736/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-sixty-ninth-meeting-committee-veterinary-medicinal-products-took-place-london-11-13-september-2001_en.pdf"},
    {"id":"8636","name":"EU/3/14/1300: Public summary of opinion on orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain for the...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T17:30:00Z","last_updated_date":"2015-03-24T16:30:00Z","reference_number":"EMA/COMP/365538/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141300-public-summary-opinion-orphan-designation-recombinant-fusion-protein-consisting-modified-form-extracellular-domain-human-activin-receptor-iib-linked-human-igg1-fc-domain_en.pdf"},
    {"id":"8639","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 2/1 vector encoding human β-hexosaminidase alpha and beta subunits","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:41:00Z","last_updated_date":"2018-01-03T14:41:00Z","reference_number":"EMA/751477/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-virus-serotype-21-vector-encoding-human-i2-hexosaminidase-alpha-and-beta-subunits_en.pdf"},
    {"id":"8641","name":"Presentation - Emerging networks: Learning from successful networks (Tim Lee, European Cystic Fibrosis Society Clinical Trials Network)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emerging-networks-learning-successful-networks-tim-lee-european-cystic-fibrosis-society-clinical-trials-network_en.pdf"},
    {"id":"8644","name":"Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2015-05-12T14:29:00Z","last_updated_date":"2015-05-12T14:29:00Z","reference_number":"EMA/161530/2014","document_url":"https://www.ema.europa.eu/en/documents/other/detailed-guide-regarding-monitoring-medical-literature-and-entry-relevant-information-eudravigilance-database-european-medicines-agency_en.pdf"},
    {"id":"8645","name":"EMA action plan for small and medium-sized enterprises (SMEs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-31T17:00:00Z","last_updated_date":"2017-05-31T17:00:00Z","reference_number":"EMA/337458/2017","document_url":"https://www.ema.europa.eu/en/documents/other/ema-action-plan-small-and-medium-sized-enterprises-smes_en.pdf"},
    {"id":"8647","name":"Final assessment report on Ilex paraguariensis St. Hilaire, folium - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-02-14T01:00:00Z","last_updated_date":"2011-02-14T01:00:00Z","reference_number":"EMA/HMPC/580545/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-ilex-paraguariensis-st-hilaire-folium-first-version_en.pdf"},
    {"id":"8648","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-17T11:00:00Z","last_updated_date":"2014-07-17T11:00:00Z","reference_number":"EMA/CAT/375230/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-june-2014-meeting_en.pdf"},
    {"id":"8650","name":"Overview of comments received on 'draft sorafenib product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116717/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-sorafenib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"8651","name":"EU/3/17/1833: Public summary of opinion on orphan designation: Autologous T-cells transduced with lentiviral vector encoding an anti-SLAMF7 CD28/CD3-zeta chimeric antigen receptor for the treatment of plasma cell myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/85419/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171833-public-summary-opinion-orphan-designation-autologous-t-cells-transduced-lentiviral-vector-encoding-anti-slamf7-cd28cd3-zeta-chimeric-antigen-receptor-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"8652","name":"EU/3/02/127: Public summary of positive opinion for orphan designation of cholic acid for the treatment of inborn errors in primary-bile-acid synthesis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2013-10-10T02:00:00Z","reference_number":"EMEA/COMP/2692/02 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302127-public-summary-positive-opinion-orphan-designation-cholic-acid-treatment-inborn-errors-primary-bile-acid-synthesis_en.pdf"},
    {"id":"8653","name":"CHMP summary of positive opinion for Memantine Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/428241/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-memantine-accord_en.pdf"},
    {"id":"8655","name":"CHMP post-authorisation summary of positive opinion for TachoSil on 18 December 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2005-12-18T01:00:00Z","last_updated_date":"2005-12-18T01:00:00Z","reference_number":"EMEA/677195/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tachosil-18-december-2008_en.pdf"},
    {"id":"8656","name":"Annual report of the European Agency for Evaluation of Medicinal Products 1996","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"1996-12-04T00:09:21Z","last_updated_date":"1996-12-04T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-1996_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-1996_es.pdf","de":"https://www.ema.europa.eu/de/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-1996_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-1996_fr.pdf"}},
    {"id":"8658","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - February 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-02-23T13:00:00Z","last_updated_date":"2012-02-23T13:00:00Z","reference_number":"EMA/CHMP/PhVWP/51794/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-february-2012_en.pdf"},
    {"id":"8659","name":"Presentation - Member of the Copa-Cogeca Working Party on Animal Health and Welfare (Catherine McLaughlin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-member-copa-cogeca-working-party-animal-health-and-welfare-catherine-mclaughlin_en.pdf"},
    {"id":"8662","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Equisetum arvense L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2016-03-17T01:09:21Z","reference_number":"EMEA/HMPC/305044/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-equisetum-arvense-l-herba_en.pdf"},
    {"id":"8663","name":"EU/3/17/1879: Public summary of opinion on orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/329481/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171879-public-summary-opinion-orphan-designation-asp-arg-val-tyr-ile-his-pro-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"8664","name":"CHMP summary of positive opinion for Xofigo","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/411215/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xofigo_en.pdf"},
    {"id":"8666","name":"Overview of comments received on 'draft capecitabine product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116324/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-capecitabine-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"8667","name":"EU/3/09/715: Public summary of opinion on orphan designation of benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] for the treatment of acute ly...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/COMP/804144/2009 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309715-public-summary-opinion-orphan-designation-benzamide-3-2-imidazo12-bpyridazin-3-ylethynyl-4-methyl-n-4-4-methyl-1-piperazinylmethyl-3-trifluoromethylphenyl-treatment-acute-ly_en.pdf"},
    {"id":"8668","name":"Withdrawal of the marketing authorisation for the medicinal product Primavax - Diphtheria, tetanus and hepatitis B vaccine","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-12-04T01:00:00Z","last_updated_date":"2000-12-04T01:00:00Z","reference_number":"EMEA/H/2681/00/Final","document_url":"https://www.ema.europa.eu/en/documents/public-statement/withdrawal-marketing-authorisation-medicinal-product-primavax-diphtheria-tetanus-and-hepatitis-b-vaccine_en.pdf"},
    {"id":"8670","name":"Draft assessment report on Vaccinium myrtillus L., fructus","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-02-09T01:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/HMPC/555161/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-vaccinium-myrtillus-l-fructus_en.pdf"},
    {"id":"8671","name":"Presentation - Impact of the single market and availability of veterinary medicines Member state perspectives: Slovakia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-single-market-and-availability-veterinary-medicines-member-state-perspectives-slovakia_en.pdf"},
    {"id":"8673","name":"Bisoprolol / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000420/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-10-18T14:01:07Z","reference_number":"EMA/580844/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/bisoprolol-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00000420201511_en.pdf"},
    {"id":"8674","name":"Presentation - Topic 2 - Industry developers perspective (Robert Wallis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-2-industry-developers-perspective-robert-wallis_en.pdf"},
    {"id":"8679","name":"Presentation - Introduction to EnprEMA and role of EMA in EnprEMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T17:10:00Z","last_updated_date":"2017-01-04T17:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-enprema-and-role-ema-enprema_en.pdf"},
    {"id":"8681","name":"Committee for medicinal products for veterinary use -\n\nEMEA public bulletin 2005 on veterinary pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-02-01T01:00:00Z","last_updated_date":"2006-02-01T01:00:00Z","reference_number":"EMEA/CVMP/226674/2005","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-emea-public-bulletin-2005-veterinary-pharmacovigilance_en.pdf"},
    {"id":"8682","name":"Work instructions on documentation of external requests for access to information and their responses","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-02-25T01:00:00Z","last_updated_date":"2011-02-25T01:00:00Z","reference_number":"WIN/H/3320","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-documentation-external-requests-access-information-and-their-responses_en.pdf"},
    {"id":"8684","name":"EU/3/13/1125: Public summary of opinion on orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-05-14T15:00:00Z","last_updated_date":"2021-05-31T17:28:00Z","reference_number":"EMA/COMP/175315/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131125-public-summary-opinion-orphan-designation-s-3-1-9h-purin-6-ylaminoethyl-8-chloro-2-phenylisoquinolin-12h-one-treatment-chronic-lymphocytic-leukaemiasmall-lymphocytic-lymphoma_en.pdf"},
    {"id":"8685","name":"Agenda - PRAC draft agenda of meeting 6-9 June 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-06-06T20:00:00Z","last_updated_date":"2016-06-06T20:00:00Z","reference_number":"EMA/PRAC/231459/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-6-9-june-2016_en.pdf"},
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    {"id":"8690","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (amyotrophic lateral sclerosis)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:30:00Z","last_updated_date":"2015-08-26T12:30:00Z","reference_number":"EMA/561345/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-mesenchymal-stem-cells-derived-whartons-jelly-tissue-umbilical-cord-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"8691","name":"Guideline on the Core SPC for human Anti-D immunoglobulin for intramuscular use - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-20T02:09:21Z","last_updated_date":"2007-09-20T02:09:21Z","reference_number":"CPMP/BPWG/574/99 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-anti-d-immunoglobulin-intramuscular-use-revision-1_en.pdf"},
    {"id":"8692","name":"Dutasteride, dutasteride / tamsulosine: List of nationally authorised medicinal products - PSUSA/00010506/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-14T13:29:00Z","last_updated_date":"2018-08-14T13:32:00Z","reference_number":"EMA/537178/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/dutasteride-dutasteride-tamsulosine-list-nationally-authorised-medicinal-products-psusa00010506201711_en.pdf"},
    {"id":"8693","name":"Recommendation on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Alzheimer's disease (CPMP/EWP/553/95) - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"EMEA/CHMP/EWP/369929/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-need-revision-guideline-clinical-investigation-medicinal-products-treatment-alzheimers-disease-cpmpewp55395-revision-1_en.pdf"},
    {"id":"8696","name":"CHMP summary of positive opinion for Unituxin","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2017-04-28T02:00:00Z","reference_number":"EMA/CHMP/303761/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-unituxin_en.pdf"},
    {"id":"8697","name":"Thomas Là¶nngren reappointed as Executive Director of the European Medicines Agency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-12-28T00:09:21Z","last_updated_date":"2005-12-28T00:09:21Z","reference_number":"EMEA/318068/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/thomas-lapnngren-reappointed-executive-director-european-medicines-agency_en.pdf"},
    {"id":"8698","name":"Mesenchymal stem cells - Science and therapeutic applications: Dr Dirk Buscher, Grifols","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/mesenchymal-stem-cells-science-and-therapeutic-applications-dr-dirk-buscher-grifols_en.pdf"},
    {"id":"8699","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (sheet)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/35691/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-burn-eschar-and-debrided-adipose-tissue-cells-sheet_en.pdf"},
    {"id":"8701","name":"Guideline on pharmacogenetics briefing meetings","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-04-27T02:00:00Z","last_updated_date":"2006-04-27T02:00:00Z","reference_number":"EMEA/CHMP/PGxWP/20227/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmacogenetics-briefing-meetings_en.pdf"},
    {"id":"8702","name":"Questions and answers on refusal of the marketing authorisation for Masiviera","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/298222/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masiviera_sv.pdf"}},
    {"id":"8703","name":"Withdrawal letter: Aripiprazole Mylan","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aripiprazole-mylan_en.pdf"},
    {"id":"8704","name":"Presentation - PRAC feedback (M. Greco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:50:00Z","last_updated_date":"2017-12-11T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prac-feedback-m-greco_en.pdf"},
    {"id":"8705","name":"Questions and answers on the withdrawal of the marketing application for Vitragan","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-05-24T02:00:00Z","last_updated_date":"2007-05-24T02:00:00Z","reference_number":"EMEA/195786/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-vitragan_sv.pdf"}},
    {"id":"8707","name":"Work instructions for managing EudraCT alerts","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2014-10-13T19:30:00Z","last_updated_date":"2014-10-13T19:30:00Z","reference_number":"WIN/INS/2053","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-managing-eudract-alerts_en.pdf"},
    {"id":"8708","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Scottish Medicines for Children Network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817613/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-scottish-medicines-children-network_en.pdf"},
    {"id":"8709","name":"The European Medicines Agency road map to 2010:\n\nPreparing the ground for the future","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-03-04T01:00:00Z","last_updated_date":"2005-03-04T01:00:00Z","reference_number":"EMEA/H/34163/03/Final","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-road-map-2010-preparing-ground-future_en.pdf"},
    {"id":"8711","name":"CHMP post-authorisation summary of positive opinion for Darzalex (II-11)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"EMA/CHMP/501485/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-ii-11_en.pdf"},
    {"id":"8712","name":"Amending budget 01-2012 for changes to entry grade for a post","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"EMA/MB/155755/2012","document_url":"https://www.ema.europa.eu/en/documents/other/amending-budget-01-2012-changes-entry-grade-post_en.pdf"},
    {"id":"8715","name":"Presentation - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting - EUPATI WP7 Guidances: Public consultation (David Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-eupati-wp7-guidances-public-consultation-david-haerry_en.pdf"},
    {"id":"8716","name":"Annual list of specific contracts based on framework contracts – 2017","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-06-28T18:30:00Z","last_updated_date":"2018-06-28T18:30:00Z","reference_number":"EMA/424076/2018","document_url":"https://www.ema.europa.eu/en/documents/other/annual-list-specific-contracts-based-framework-contracts-2017_en.pdf"},
    {"id":"8717","name":"Presentation - Benefit-risk assessment throughout the drug lifecycle: future challenges? (Hans-Georg Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-benefit-risk-assessment-throughout-drug-lifecycle-future-challenges-hans-georg-eichler_en.pdf"},
    {"id":"8718","name":"Approaches on how to consider excipients in the context of Regulation 2377/90","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-11-23T00:09:21Z","last_updated_date":"2005-11-23T00:09:21Z","reference_number":"EMEA/CVMP/223005/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/approaches-how-consider-excipients-context-regulation-237790_en.pdf"},
    {"id":"8721","name":"Draft list of references supporting the assessment of Marrubium vulgare L., herba - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-01-28T01:00:00Z","last_updated_date":"2013-01-28T01:00:00Z","reference_number":"EMA/HMPC/604272/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-marrubium-vulgare-l-herba-first-version_en.pdf"},
    {"id":"8722","name":"Principles for publication of agendas and minutes of EMA scientific committees","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-18T13:00:00Z","last_updated_date":"2013-12-18T13:00:00Z","reference_number":"EMA/555647/2013","document_url":"https://www.ema.europa.eu/en/documents/other/principles-publication-agendas-and-minutes-ema-scientific-committees_en.pdf"},
    {"id":"8723","name":"European Medicines Agency adopts first positive opinion for a similar biological medicinal product","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-01-27T00:09:21Z","last_updated_date":"2006-01-27T00:09:21Z","reference_number":"EMEA/31797/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-adopts-first-positive-opinion-similar-biological-medicinal-product_en.pdf"},
    {"id":"8724","name":"Stratification of sales data of antimicrobials by species - Data collection protocol 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T16:30:00Z","last_updated_date":"2018-07-05T16:30:00Z","reference_number":"EMA/284404/2018","document_url":"https://www.ema.europa.eu/en/documents/report/stratification-sales-data-antimicrobials-species-data-collection-protocol-2017_en.pdf"},
    {"id":"8725","name":"EU/3/09/616: Public summary of positive opinion for orphan designation\n\nof (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMEA/COMP/107945/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309616-public-summary-positive-opinion-orphan-designation-6r-4567-tetrahydro-n6-propyl-26-benzothiazolediamine-dihydrochloride-monohydrate-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"8726","name":"Withdrawal assessment report for Pioglitazone Ratiopharm GmbH","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2012-07-12T13:55:00Z","last_updated_date":"2012-07-12T13:55:00Z","reference_number":"EMA/394132/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-pioglitazone-ratiopharm-gmbh_en.pdf"},
    {"id":"8728","name":"Nicardipine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-12T13:00:00Z","last_updated_date":"2014-03-12T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nicardipine-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nicardipine-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nicardipine-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nicardipine-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nicardipine-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nicardipine-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nicardipine-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nicardipine-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nicardipine-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nicardipine-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nicardipine-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nicardipine-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nicardipine-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nicardipine-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nicardipine-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nicardipine-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nicardipine-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nicardipine-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nicardipine-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nicardipine-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nicardipine-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nicardipine-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nicardipine-article-31-referral-annex-i_sv.pdf"}},
    {"id":"8729","name":"Annex 10 – 2016 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2017-05-10T12:00:00Z","last_updated_date":"2017-05-10T12:00:00Z","reference_number":"EMA/4995/2017","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annex-10-2016-annual-report-european-medicines-agency-chmp-opinions-initial-evaluations-and-extensions-therapeutic-indication_en.xlsx"},
    {"id":"8731","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12-14 October 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-11-07T11:55:00Z","last_updated_date":"2016-11-07T11:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-14-october-2016_en.pdf"},
    {"id":"8734","name":"Questions and answers relating to open procedure – EMA 2012-37-ED Online strategy and interface design","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-27T12:50:00Z","last_updated_date":"2013-06-27T12:50:00Z","reference_number":"EMA/352562/2013","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-open-procedure-ema-2012-37-ed-online-strategy-and-interface-design_en.pdf"},
    {"id":"8737","name":"CHMP post authorisation summary of positive opinion for ViraferonPeg on 24 September 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2021-01-22T02:00:00Z","reference_number":"EMEA/CHMP/612232/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-viraferonpeg-24-september-2009_en.pdf"},
    {"id":"8738","name":"Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-07-03T18:00:00Z","last_updated_date":"2012-07-03T18:00:00Z","reference_number":"EMA/446469/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/janssen-cilag-international-nv-withdraws-its-application-extension-indication-velcade-bortezomib_en.pdf"},
    {"id":"8739","name":"Note for guidance: Investigation of chiral active substances","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-06-01T02:00:00Z","last_updated_date":"1997-06-01T02:00:00Z","reference_number":"EMEA/CVMP/128/95-Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-investigation-chiral-active-substances_en.pdf"},
    {"id":"8740","name":"EU/3/13/1176: Public summary of opinion on orphan designation: Human allogeneic bone-marrow-derived osteoblastic-like cells for the treatment of non-traumatic osteonecrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-13T02:00:00Z","last_updated_date":"2013-09-13T02:00:00Z","reference_number":"EMA/COMP/439952/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131176-public-summary-opinion-orphan-designation-human-allogeneic-bone-marrow-derived-osteoblastic-cells-treatment-non-traumatic-osteonecrosis_en.pdf"},
    {"id":"8743","name":"Letter from the European Medicines Agency to Ms M Rivasi regarding Dr Xavier Kurz","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-26T15:00:00Z","last_updated_date":"2011-10-26T15:00:00Z","reference_number":"EMA/858830/2011","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-medicines-agency-ms-m-rivasi-regarding-dr-xavier-kurz_en.pdf"},
    {"id":"8745","name":"Working party on Herbal Medicinal Products: Draft proposal for a Devil's claw root","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2000-04-04T02:00:00Z","last_updated_date":"2000-04-04T02:00:00Z","reference_number":"EMEA/HMPWP/21/00","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-draft-proposal-devils-claw-root_en.pdf"},
    {"id":"8747","name":"Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the 'Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014' - Specific comments received on...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-12-03T13:30:00Z","last_updated_date":"2015-12-03T13:30:00Z","reference_number":"EMA/739152/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-ema6414792014-draft-proposal-addendum-transparency-functional-specifications-eu-portal-and-eu-database-be-audited-ema421762014-specific-comments-received_en.pdf"},
    {"id":"8749","name":"Committee for medicinal products for human use, summary of positive opinion for Pantecta Control","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMEA/CHMP/108580/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-pantecta-control_en.pdf"},
    {"id":"8750","name":"CVMP post-authorisation summary of positive opinion for Rheumocam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-14T02:00:00Z","last_updated_date":"2012-09-14T02:00:00Z","reference_number":"EMA/CVMP/396534/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-rheumocam_en.pdf-0"},
    {"id":"8751","name":"General principles - European Medicines Agency / Veterinary Medicines and Inspections Unit - Food and Drug Administration / Center for Veterinary Medicine - Parallel scientific-advice meetings","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-05-22T02:09:21Z","last_updated_date":"2008-05-22T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/general-principles-european-medicines-agency-veterinary-medicines-and-inspections-unit-food-and-drug-administration-center-veterinary-medicine-parallel-scientific-advice-meetings_en.pdf"},
    {"id":"8752","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: September 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-10-13T19:00:00Z","last_updated_date":"2014-10-13T19:00:00Z","reference_number":"EMA/484743/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-september-2014_en.pdf"},
    {"id":"8753","name":"Presentation - Immunogenicity guideline: basic description (Venke Skibeli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunogenicity-guideline-basic-description-venke-skibeli_en.pdf"},
    {"id":"8756","name":"EU/3/11/941: Public summary of positive opinion for orphan designation: Lipopolysaccharide of Ochrobactrum intermedium for the prevention of sepsis in at-risk premature infants of less than or equal to 32 weeks of gestat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2014-10-08T16:00:00Z","reference_number":"EMA/COMP/938586/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311941-public-summary-positive-opinion-orphan-designation-lipopolysaccharide-ochrobactrum-intermedium-prevention-sepsis-risk-premature-infants-less-or-equal-32-weeks-gestat_en.pdf"},
    {"id":"8757","name":"Draft appendix 1 to the guideline on the evaluation of anticancer medicinal products in man (CHMP/EWP/205/95 rev. 3), methodological considerations for using Progression-Free Survival (PFS) as primary endpoint in confirm...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-07-27T02:09:21Z","last_updated_date":"2006-07-27T02:09:21Z","reference_number":"EMEA/CHMP/EWP/267575/2006/Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-appendix-1-guideline-evaluation-anticancer-medicinal-products-man-chmpewp20595-rev-3-methodological-considerations-using-progression-free-survival-pfs-primary-endpoint-confirm_en.pdf"},
    {"id":"8759","name":"Presentation - Interaction with healthcare professionals (I.Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-healthcare-professionals-isilva-ema_en.pdf"},
    {"id":"8760","name":"Presentation and discussion of various case studies - Matthew Thatcher","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-11-16T00:09:21Z","last_updated_date":"2009-11-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-and-discussion-various-case-studies-matthew-thatcher_en.pdf"},
    {"id":"8761","name":"Overview of comments received on 'draft tadalafil product-specific bioequivalence guidance' - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116444/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-tadalafil-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"8762","name":"Overview of comments received on draft Reflection Paper on the risks associated with furocoumarins contained in preparations of Angelica archangelica L.","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/277293/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-reflection-paper-risks-associated-furocoumarins-contained-preparations-angelica-archangelica-l_en.pdf"},
    {"id":"8763","name":"CHMP post-authorisation summary of positive opinion for Galvus","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/600948/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-galvus_en.pdf"},
    {"id":"8765","name":"European Medicines Agency notified of recall of swine fever vaccine (Porcilis Pesti) by Intervet International BV","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-05-05T02:00:00Z","last_updated_date":"2008-05-05T02:00:00Z","reference_number":"EMEA/237728/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-notified-recall-swine-fever-vaccine-porcilis-pesti-intervet-international-bv_en.pdf"},
    {"id":"8766","name":"Coding of indications in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-01T17:06:00Z","last_updated_date":"2015-12-01T17:06:00Z","reference_number":"EMA/245789/2015","document_url":"https://www.ema.europa.eu/en/documents/other/coding-indications-extended-eudravigilance-medicinal-product-dictionary-xevmpd_en.pdf"},
    {"id":"8767","name":"CHMP post-authorisation summary of positive opinion for Alimta on 29 May 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-05-29T02:09:21Z","last_updated_date":"2009-05-29T02:09:21Z","reference_number":"EMEA/CHMP/331827/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-alimta-29-may-2009_en.pdf"},
    {"id":"8768","name":"Withdrawal assessment report for Zafiride","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-02-08T01:00:00Z","last_updated_date":"2018-02-08T01:00:00Z","reference_number":"EMA/353057/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zafiride_en.pdf"},
    {"id":"8769","name":"Technical specifications - Annex VI - Service level agreement - EMA/2012/18/HR Procurement procedure for medical services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-vi-service-level-agreement-ema201218hr-procurement-procedure-medical-services_en.pdf"},
    {"id":"8770","name":"Methylphenidate Sandoz Article-29 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-05T01:00:00Z","last_updated_date":"2013-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/methylphenidate-sandoz-article-29-referral-annex-i_no.pdf"}},
    {"id":"8771","name":"Deslorelin acetate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-02-01T01:00:00Z","last_updated_date":"2002-02-01T01:00:00Z","reference_number":"EMEA/MRL/830/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/deslorelin-acetate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"8775","name":"Agenda and registration form  - eXtended EudraVigilance medicinal product dictionary face-to-face training course, Madrid","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-23T13:00:00Z","last_updated_date":"2017-11-23T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-madrid_en.pdf"},
    {"id":"8776","name":"Presentation - Ph 2/3 trial for selepressin in the treatment of vasopressor-dependent septic shock (Scott Berry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ph-23-trial-selepressin-treatment-vasopressor-dependent-septic-shock-scott-berry_en.pdf"},
    {"id":"8777","name":"Lansoprazol-ratiopharm 15 mg and 30 mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-02-25T00:08:21Z","last_updated_date":"2006-02-25T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lansoprazol-ratiopharm-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
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    {"id":"8780","name":"Mandate, objectives and rules of procedure for the HMPC Working Party on Community Monographs and Community List (MLWP)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-01-10T00:09:21Z","last_updated_date":"2018-03-09T16:00:00Z","reference_number":"EMA/HMPC/358825/2005","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-hmpc-working-party-community-monographs-and-community-list-mlwp_en.pdf"},
    {"id":"8781","name":"Draft list of references supporting the assessment of Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-08-30T02:00:00Z","last_updated_date":"2011-08-30T02:00:00Z","reference_number":"EMA/HMPC/239270/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-fraxinus-excelsior-l-and-fraxinus-angustifolia-vahl-folium_en.pdf"},
    {"id":"8783","name":"Superseded assessment report on Valeriana officinalis L., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-11-29T00:09:21Z","last_updated_date":"2016-04-28T01:09:21Z","reference_number":"EMEA/HMPC/167391/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"8784","name":"Miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide: List of nationally authorised medicinal products -PSUSA/00002052/201410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T02:00:00Z","last_updated_date":"2016-10-18T11:46:16Z","reference_number":"EMA/398898/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/miconazole-hydrocortisone-miconazole-nitrate-miconazole-nitrate-zinc-oxide-list-nationally-authorised-medicinal-products-psusa00002052201410_en.pdf"},
    {"id":"8785","name":"Memorandum - Expert group of quality assessors – work report","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-06T01:00:00Z","last_updated_date":"2012-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/memorandum-expert-group-quality-assessors-work-report_en.pdf"},
    {"id":"8786","name":"Public Statement on the use of herbal medicinal products containing methyleugenol","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-23T01:00:00Z","last_updated_date":"2005-11-23T01:00:00Z","reference_number":"EMEA/HMPC/138363/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-use-herbal-medicinal-products-containing-methyleugenol_en.pdf"},
    {"id":"8787","name":"Presentation - The impact on public and animal health of the use of antibiotics in animals (John Threlfall)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-public-and-animal-health-use-antibiotics-animals-john-threlfall_en.pdf"},
    {"id":"8789","name":"Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-01-15T02:00:00Z","last_updated_date":"2012-01-15T02:00:00Z","reference_number":"CPMP/EWP/558/95 rev 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-2_en.pdf"},
    {"id":"8790","name":"EU/3/13/1107: Public summary of opinion on orphan designation:\n\nRecombinant adeno-associated viral vector containing the human retinoschisin gene for the treatment of X-linked juvenile retinoschisis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-05T02:00:00Z","last_updated_date":"2013-04-05T02:00:00Z","reference_number":"EMA/COMP/94352/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131107-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-containing-human-retinoschisin-gene-treatment-x-linked-juvenile-retinoschisis_en.pdf"},
    {"id":"8791","name":"Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-17T18:39:17Z","reference_number":"EMA/346549/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa00001744201508_en.pdf"},
    {"id":"8793","name":"Small- and medium-sized-enterprises (SME) and medicines in 2014 - Marketing authorisation applications received","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/small-and-medium-sized-enterprises-sme-and-medicines-2014-marketing-authorisation-applications-received_en.pdf"},
    {"id":"8794","name":"Draft list of references supporting the assessment of Gentiana lutea L., radix – Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/607862/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-gentiana-lutea-l-radix-revision-1_en.pdf"},
    {"id":"8795","name":"Regulators perspective on 'Quality by Design': QWP perspective - Jean-Louis Robert","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-09-28T02:09:21Z","last_updated_date":"2009-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/regulators-perspective-quality-design-qwp-perspective-jean-louis-robert_en.pdf"},
    {"id":"8796","name":"Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-10-25T02:00:00Z","last_updated_date":"2011-10-25T02:00:00Z","reference_number":"EMA/856472/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/xigris-drotrecogin-alfa-activated-be-withdrawn-due-lack-efficacy_en.pdf"},
    {"id":"8797","name":"Presentation - The patient perspective: Adaptive licensing (Emily Crossley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-perspective-adaptive-licensing-emily-crossley_en.pdf"},
    {"id":"8800","name":"Compliance Group mandate: Joint Audit Programme for EEA GMP Inspectorates","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T17:10:00Z","last_updated_date":"2021-03-10T10:18:00Z","reference_number":"EMA/398531/2020 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/other/compliance-group-mandate-joint-audit-programme-eea-gmp-inspectorates_en.pdf"},
    {"id":"8807","name":"Agenda - Second stakeholders forum on the implementation of the new pharmacovigilance legislation","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2011-06-10T03:00:00Z","last_updated_date":"2011-06-24T03:00:00Z","reference_number":"EMA/366836/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-stakeholders-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"8808","name":"Zocord - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-06-09T02:08:21Z","last_updated_date":"2004-06-09T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zocord-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/zocord-article-30-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zocord-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zocord-article-30-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zocord-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zocord-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zocord-article-30-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zocord-article-30-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zocord-article-30-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zocord-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zocord-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"8809","name":"Withdrawal letter: Cavoley","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-cavoley_en.pdf"},
    {"id":"8810","name":"Tetrabenazine: List of nationally authorised medicinal products - PSUSA/00002911/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-14T19:00:00Z","last_updated_date":"2017-06-14T19:00:00Z","reference_number":"EMA/366993/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tetrabenazine-list-nationally-authorised-medicinal-products-psusa00002911201610_en.pdf"},
    {"id":"8811","name":"EU/3/15/1441: Public summary of opinion on orphan designation: 5-hydroxymethyl-2-furfural for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2016-02-10T01:00:00Z","reference_number":"EMA/COMP/48633/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151441-public-summary-opinion-orphan-designation-5-hydroxymethyl-2-furfural-treatment-sickle-cell-disease_en.pdf"},
    {"id":"8813","name":"Combined hormonal contraceptives Article-31 referral - Annex I","type":"referral","status":"Draft","consultation_date":"","first_published_date":"2013-02-08T13:00:00Z","last_updated_date":"2013-03-11T13:35:00Z","reference_number":"EMA/713187/2012 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-i_en.pdf"},
    {"id":"8818","name":"Public Statement on the use of herbal medicinal products containing pulegone and menthofuran - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-23T01:00:00Z","last_updated_date":"2005-11-23T01:00:00Z","reference_number":"EMEA/HMPC/138386/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-use-herbal-medicinal-products-containing-pulegone-and-menthofuran-first-version_en.pdf"},
    {"id":"8819","name":"Astellas withdraws its marketing authorisation application for Vibativ (telavancin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-24T02:09:21Z","last_updated_date":"2008-10-24T02:09:21Z","reference_number":"EMEA/562428/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/astellas-withdraws-its-marketing-authorisation-application-vibativ-telavancin_en.pdf"},
    {"id":"8822","name":"CHMP post-authorisation summary of positive opinion for Binocrit","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/499769/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-binocrit_en.pdf"},
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    {"id":"8830","name":"Guidelines and concept papers adopted at the CHMP meeting 21-24 October 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T17:30:00Z","last_updated_date":"2013-10-29T17:30:00Z","reference_number":"EMA/653473/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-chmp-meeting-21-24-october-2013_en.pdf"},
    {"id":"8833","name":"EU/3/00/008: Public summary of positive opinion for orphan designation of arsenic trioxide for the treatment of acute promyelocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-04T02:00:00Z","last_updated_date":"2013-10-17T18:00:00Z","reference_number":"EMEA/COMP/9747/2003 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300008-public-summary-positive-opinion-orphan-designation-arsenic-trioxide-treatment-acute-promyelocytic-leukaemia_en.pdf"},
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    {"id":"8835","name":"CVMP summary of positive opinion for Bovilis BTV8","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2022-07-27T11:23:00Z","reference_number":"EMA/CVMP/115976/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-bovilis-btv8_en.pdf"},
    {"id":"8836","name":"Adrenaline auto-injectors Article-31 referral - CHMP List of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/CHMP/225802/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/adrenaline-auto-injectors-article-31-referral-chmp-list-questions_en.pdf"},
    {"id":"8837","name":"Presentation - Framework on the interaction between the European Medicines Agency and healthcare professionals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-framework-interaction-between-european-medicines-agency-and-healthcare-professionals_en.pdf"},
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    {"id":"8839","name":"CHMP summary of positive opinion for Darunavir Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/573531/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-darunavir-mylan_en.pdf"},
    {"id":"8840","name":"Submission of comments form","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-17T14:30:00Z","last_updated_date":"2017-02-17T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/submission-comments-form_en.doc"},
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    {"id":"8845","name":"Matricaria flower - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-04-05T17:30:00Z","last_updated_date":"2016-04-05T17:30:00Z","reference_number":"EMA/490629/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/matricaria-flower-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/matricaria-flower-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/matricaria-flower-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/matricaria-flower-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/matricaria-flower-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/matricaria-flower-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/matricaria-flower-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/matricaria-flower-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/matricaria-flower-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/matricaria-flower-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/matricaria-flower-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/matricaria-flower-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/matricaria-flower-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/matricaria-flower-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/matricaria-flower-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/matricaria-flower-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/matricaria-flower-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/matricaria-flower-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/matricaria-flower-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/matricaria-flower-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/matricaria-flower-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/matricaria-flower-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/matricaria-flower-summary-public_sv.pdf"}},
    {"id":"8846","name":"EU/3/17/1969: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits for the treatment of GM2 gangliosidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-13T01:00:00Z","last_updated_date":"2018-03-13T01:00:00Z","reference_number":"EMA/826135/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171969-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-21-encoding-human-beta-hexosaminidase-alpha-and-beta-subunits-treatment-gm2-gangliosidosis_en.pdf"},
    {"id":"8848","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Sirturo (bedaquiline) for the treatment of tuberculosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-03-14T17:00:00Z","last_updated_date":"2014-03-14T17:00:00Z","reference_number":"EMA/COMP/3833/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-sirturo-bedaquiline-treatment-tuberculosis_en.pdf"},
    {"id":"8849","name":"EGA-EBG's Non-Clinical perspective on Biosimilar mAbs - Alexander Berghout","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ega-ebgs-non-clinical-perspective-biosimilar-mabs-alexander-berghout_en.pdf"},
    {"id":"8851","name":"New treatment for advanced form of kidney cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T13:01:00Z","last_updated_date":"2016-02-26T13:01:00Z","reference_number":"EMA/CHMP/147283/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-treatment-advanced-form-kidney-cancer_en.pdf"},
    {"id":"8852","name":"Presentation - EMA framework of collaboration with academia - European Medicines Agency veterinary medicines innovation day (Monica Ensini)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-framework-collaboration-academia-european-medicines-agency-veterinary-medicines-innovation-day-monica-ensini_en.pdf"},
    {"id":"8853","name":"Questions and answers on withdrawal of marketing application for Ximelagatran Astrazeneca 36 mg film coated tablets","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-02-23T01:00:00Z","last_updated_date":"2006-02-23T01:00:00Z","reference_number":"EMEA/60465/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ximelagatran-astrazeneca-36-mg-film-coated-tablets_en.pdf"},
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    {"id":"8856","name":"EU/3/04/243: Public summary of positive opinion for orphan designation of alpha-1 antitrypsin (inhalation use) for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2013-02-07T01:00:00Z","reference_number":"EMA/COMP/109837/2004 Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304243-public-summary-positive-opinion-orphan-designation-alpha-1-antitrypsin-inhalation-use-treatment-cystic-fibrosis_en.pdf"},
    {"id":"8857","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 8-11 November 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-11-21T17:50:00Z","last_updated_date":"2016-11-21T17:50:00Z","reference_number":"EMA/PDCO/102084/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-8-11-november-2016_en.pdf"},
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    {"id":"8861","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 18 to 20 February 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-02-24T01:00:00Z","last_updated_date":"2003-02-24T01:00:00Z","reference_number":"EMEA/CPMP/890/03/Rev. 1/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-18-20-february-2003_en.pdf"},
    {"id":"8862","name":"Questions and answers on the withdrawal of the marketing authorisation application for Raxone","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/242206/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-raxone_sv.pdf"}},
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    {"id":"8867","name":"Ginseng: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/669/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ginseng-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"8870","name":"Etopophos Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/etopophos-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/etopophos-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/etopophos-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/etopophos-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/etopophos-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/etopophos-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/etopophos-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/etopophos-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/etopophos-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/etopophos-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/etopophos-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/etopophos-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/etopophos-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/etopophos-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/etopophos-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/etopophos-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/etopophos-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/etopophos-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/etopophos-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/etopophos-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/etopophos-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/etopophos-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/etopophos-article-30-referral-annex-iii_sv.pdf"}},
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    {"id":"8872","name":"Joint Committee Opinion n.1/2011 of 8 March 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-03-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joint-committee-opinion-n12011-8-march-2011_en.pdf"},
    {"id":"8873","name":"Agenda and registration form - Introduction to pharmacovigilance and rules for expedited reporting of individual case safety reports (ICSRs) in Europe","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T11:00:00Z","last_updated_date":"2015-01-29T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-introduction-pharmacovigilance-and-rules-expedited-reporting-individual-case-safety-reports-icsrs-europe_en.pdf"},
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    {"id":"8880","name":"Overview of comments received on draft guideline on\n\nvalidation of immunoassay for the detection of antibody to human immunodeficiency virus (anti-HIV) in plasma pools","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-21T02:00:00Z","last_updated_date":"2006-09-21T02:00:00Z","reference_number":"EMEA/CHMP/BWP/94182/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-validation-immunoassay-detection-antibody-human-immunodeficiency-virus-anti-hiv-plasma-pools_en.pdf"},
    {"id":"8885","name":"Reflection paper on clinical aspects related to tissue engineered products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-12-11T16:30:00Z","last_updated_date":"2014-12-11T16:30:00Z","reference_number":"EMA/CAT/573420/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-clinical-aspects-related-tissue-engineered-products_en.pdf"},
    {"id":"8887","name":"Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/602744/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/pharmaceutics-international-inc-us-supply-non-critical-medicines-eu-be-stopped-due-manufacturing-failings_en.pdf"},
    {"id":"8888","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Besponsa (inotuzumab ozogamicin) for the treatment of B-cell acute lymphoblastic leukaemia","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-07-13T12:46:00Z","last_updated_date":"2017-07-13T12:46:00Z","reference_number":"EMA/320642/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-besponsa-inotuzumab-ozogamicin-treatment-b-cell-acute-lymphoblastic-leukaemia_en.pdf"},
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    {"id":"8898","name":"Echinacea (Use in veterinary homeopathy): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/687/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/echinacea-use-veterinary-homeopathy-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"8899","name":"Withdrawal assessment report for Docetaxel SUN","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-09-29T02:00:00Z","last_updated_date":"2016-09-29T02:00:00Z","reference_number":"EMA/434463/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-docetaxel-sun_en.pdf"},
    {"id":"8900","name":"European and international experts discuss the way forward in stem-cell research and development","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"EMA/274082/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-and-international-experts-discuss-way-forward-stem-cell-research-and-development_en.pdf"},
    {"id":"8901","name":"Presentation - Functioning of the PRAC (Almath Spooner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-functioning-prac-almath-spooner_en.pdf"},
    {"id":"8902","name":"Final European Union herbal monograph on Salvia officinalis L., folium - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-07-13T02:00:00Z","last_updated_date":"2017-07-13T02:00:00Z","reference_number":"EMA/HMPC/277152/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-salvia-officinalis-l-folium-revision-1_en.pdf"},
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    {"id":"8912","name":"Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-02-28T10:30:00Z","last_updated_date":"2012-02-28T10:30:00Z","reference_number":"EMA/HMPC/833398/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-necessity-initiatives-stimulate-conduct-clinical-studies-herbal-medicinal-products-paediatric-population_en.pdf"},
    {"id":"8915","name":"ICH: Q 4 B Annex 4B: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on microbiological examination of non-sterile products: Tests for specified micro-organisms - General chap...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2008-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/308817/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-4b-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-microbiological-examination-non-sterile-products-tests-specified-micro-organisms-general-chap_en.pdf"},
    {"id":"8917","name":"EU/3/12/1021: Public summary of opinion on orphan designation: 1-[(2-Chloro-4-methoxyphenoxy)methyl]-4-[(2,6-dichlorophenoxy)methyl]benzene for the prevention of poliomyelitis in patients with immunodeficiencies deemed a...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-08-31T12:30:00Z","last_updated_date":"2013-03-12T11:30:00Z","reference_number":"EMA/COMP/446487/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121021-public-summary-opinion-orphan-designation-1-2-chloro-4-methoxyphenoxymethyl-4-26-dichlorophenoxymethylbenzene-prevention-poliomyelitis-patients-immunodeficiencies-deemed_en.pdf"},
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    {"id":"8933","name":"Flugestone acetate: Summary report  (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-05-01T02:00:00Z","last_updated_date":"2005-05-01T02:00:00Z","reference_number":"EMEA/CVMP/139560/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flugestone-acetate-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"8936","name":"Application form: Call for expressions of interest for drug safety studies","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-04-13T02:00:00Z","last_updated_date":"2014-07-28T18:25:00Z","reference_number":"EMA/988338/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-form-call-expressions-interest-drug-safety-studies_en.pdf"},
    {"id":"8938","name":"Report - Information session on antimicrobial resistance on 19 September 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T11:30:00Z","last_updated_date":"2017-11-14T15:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-information-session-antimicrobial-resistance-19-september-2017_en.pdf"},
    {"id":"8939","name":"EU/3/14/1333: Public summary of opinion on orphan designation: Lumacaftor/ivacaftor for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"EMA/COMP/440253/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141333-public-summary-opinion-orphan-designation-lumacaftorivacaftor-treatment-cystic-fibrosis_en.pdf"},
    {"id":"8940","name":"Guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/125459/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-studies-required-first-clinical-use-gene-therapy-medicinal-products_en.pdf"},
    {"id":"8941","name":"Superseded assessment report on Mentha x piperita L., aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/349465/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-mentha-x-piperita-l-aetheroleum_en.pdf"},
    {"id":"8942","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Recombinant herpes simplex virus type 1 (HSV-1) containing the gene encoding human granulocyte macrophage colony-stimulating factor (GM-...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-12-17T16:00:00Z","last_updated_date":"2012-12-17T16:00:00Z","reference_number":"EMA/494706/2012","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-herpes-simplex-virus-type-1-hsv-1-containing-gene-encoding-human-granulocyte-macrophage-colony-stimulating_en.pdf"},
    {"id":"8944","name":"Concept paper on the development of a Committee for Proprietary Medicinal Products (CPMP) guideline on comparability of biotechnology-derived products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"1998-06-24T02:00:00Z","last_updated_date":"1998-06-24T02:00:00Z","reference_number":"CPMP/BWP/113/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-proprietary-medicinal-products-cpmp-guideline-comparability-biotechnology-derived-products_en.pdf"},
    {"id":"8945","name":"Presentation – Update on the implementation of EMA policy on publication of clinical data (Policy 0070) – industry associations webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-05T02:00:00Z","last_updated_date":"2017-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-implementation-ema-policy-publication-clinical-data-policy-0070-industry-associations-webinar_en.pdf"},
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    {"id":"8949","name":"Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-06-23T02:00:00Z","last_updated_date":"2005-06-23T02:00:00Z","reference_number":"CPMP/EWP/422/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis-first-version_en.pdf"},
    {"id":"8952","name":"Presentation - European Network for Hyperkinetic Disorders (Dave Coghill, University of Dundee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-hyperkinetic-disorders-dave-coghill-university-dundee_en.pdf"},
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    {"id":"8960","name":"EMEA Management Board adopts fee implementing rule and looks at the Agency's corporate governance","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-06-09T02:09:21Z","last_updated_date":"2003-06-09T02:09:21Z","reference_number":"EMEA/MB/224/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-management-board-adopts-fee-implementing-rule-and-looks-agencys-corporate-governance_en.pdf"},
    {"id":"8962","name":"Flumazenil: List of nationally authorised medicinal products - PSUSA/00001413/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-12T02:00:00Z","last_updated_date":"2016-10-18T16:31:59Z","reference_number":"EMA/606912/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/flumazenil-list-nationally-authorised-medicinal-products-psusa00001413201512_en.pdf"},
    {"id":"8963","name":"Recommendation for removal of orphan designation at the time of marketing authorisation: Cuprior (trientine tetrahydrochloride) for the treatment of Wilson's disease","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2017-10-03T19:00:00Z","last_updated_date":"2017-10-03T19:00:00Z","reference_number":"EMA/568817/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-removal-orphan-designation-time-marketing-authorisation-cuprior-trientine-tetrahydrochloride-treatment-wilsons-disease_en.pdf"},
    {"id":"8964","name":"Agenda and registration form - 14th EudraVigilance information day, 23 May 2013","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-04-17T18:50:00Z","last_updated_date":"2013-04-22T13:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-14th-eudravigilance-information-day-23-may-2013_en.pdf"},
    {"id":"8966","name":"EU/3/14/1249: Public summary of opinion on orphan designation: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III for the treatment of familial chylomicronaemia syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-03T12:00:00Z","last_updated_date":"2014-04-03T12:00:00Z","reference_number":"EMA/COMP/30845/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141249-public-summary-opinion-orphan-designation-phosphorothioate-oligonucleotide-targeted-apolipoprotein-c-iii-treatment-familial-chylomicronaemia-syndrome_en.pdf"},
    {"id":"8969","name":"EU/3/11/850: Public summary of positive opinion for orphan designation: Darinaparsin for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMA/COMP/71586/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311850-public-summary-positive-opinion-orphan-designation-darinaparsin-treatment-peripheral-t-cell-lymphoma-nodal-other-extranodal-and-leukaemicdisseminated_en.pdf"},
    {"id":"8970","name":"Letrozole: List of nationally authorised medicinal products - PSUSA/00001842/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-15T02:00:00Z","last_updated_date":"2016-10-17T19:17:15Z","reference_number":"EMA/418272/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/letrozole-list-nationally-authorised-medicinal-products-psusa00001842201510_en.pdf"},
    {"id":"8972","name":"Opinion following an Article 29(2) referral for Crestor 5 mg International Non-Proprietary Name (INN): Rosuvastatin calcium: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2005-08-09T02:08:21Z","last_updated_date":"2005-08-09T02:08:21Z","reference_number":"EMEA/CHMP/145829/2005","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-292-referral-crestor-5-mg-international-non-proprietary-name-inn-rosuvastatin-calcium-background-information_sv.pdf"}},
    {"id":"8975","name":"Presentation - Generics in the Centralised Procedure","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-generics-centralised-procedure_en.pdf"},
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    {"id":"8990","name":"Presentation - French National Agency for Medicines and Health Products Safety: Innovation Office (Francois Cuenot)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-french-national-agency-medicines-and-health-products-safety-innovation-office-francois-cuenot_en.pdf"},
    {"id":"8991","name":"Updated temporary treatment recommendations for Cerezyme","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/665112/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/updated-temporary-treatment-recommendations-cerezyme_en.pdf"},
    {"id":"8996","name":"CHMP summary of positive opinion for Pioglitazone Krka","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/CHMP/423166/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pioglitazone-krka_en.pdf"},
    {"id":"8997","name":"Guideline on procedures for competent authorities for pharmacovigilance information for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-04-15T02:00:00Z","last_updated_date":"2004-04-15T02:00:00Z","reference_number":"EMEA/CVMP/345/98-Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-procedures-competent-authorities-pharmacovigilance-information-veterinary-medicinal-products_en.pdf"},
    {"id":"8999","name":"Norethisterone: List of nationally authorised medicinal products - PSUSA/00002188/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T15:36:00Z","last_updated_date":"2018-04-19T15:41:01Z","reference_number":"EMA/210995/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/norethisterone-list-nationally-authorised-medicinal-products-psusa00002188201708_en.pdf"},
    {"id":"9000","name":"Rafoxanide (bovine and ovine milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-18T02:00:00Z","last_updated_date":"2014-08-18T02:00:00Z","reference_number":"EMA/CVMP/592866/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/rafoxanide-bovine-and-ovine-milk-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"9002","name":"Presentation - Objectives expert meeting: List of questions: Preliminary answers","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-12T03:00:00Z","last_updated_date":"2011-07-12T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-expert-meeting-list-questions-preliminary-answers_en.pdf"},
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    {"id":"9005","name":"Draft list of references for assessment of: Hamamelis cortex, Hamamelis folium, Hamamelis folium et cortex, distillate Hamamelis virginiana L. (hamamelis bark, hamamelis leaf, hamamelis distillate)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/115209/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-hamamelis-cortex-hamamelis-folium-hamamelis-folium-et-cortex-distillate-hamamelis-virginiana-l-hamamelis-bark-hamamelis-leaf-hamamelis-distillate_en.pdf"},
    {"id":"9006","name":"EU/3/13/1219: Public summary of opinion on orphan designation: Fenfluramine hydrochloride for the treatment of Dravet syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2020-11-06T01:00:00Z","reference_number":"EMA/COMP/700717/2013 Corr.","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131219-public-summary-opinion-orphan-designation-fenfluramine-hydrochloride-treatment-dravet-syndrome_en.pdf"},
    {"id":"9008","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Hubertus Cranz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-hubertus-cranz_en.pdf"},
    {"id":"9009","name":"EU/3/12/1096: Public summary of opinion on orphan designation: Terguride for the treatment of systemic sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2021-03-22T01:00:00Z","reference_number":"EMA/COMP/2116/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121096-public-summary-opinion-orphan-designation-terguride-treatment-systemic-sclerosis_en.pdf"},
    {"id":"9010","name":"EU/3/10/780: Public summary of opinion on orphan designation: Forodesine for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2010-10-18T02:00:00Z","reference_number":"EMA/COMP/397978/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310780-public-summary-opinion-orphan-designation-forodesine-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"9011","name":"Presentation - Regulatory initiatives for measuring the impact of pharmacovigilance (Dolores Montero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-initiatives-measuring-impact-pharmacovigilance-dolores-montero_en.pdf"},
    {"id":"9012","name":"EU/3/13/1193: Public summary of opinion on orphan designation:\n\n3,5-diiodothyropropionic acid for the treatment of Allan-Herndon-Dudley syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2013-10-31T01:00:00Z","reference_number":"EMA/COMP/562044/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131193-public-summary-opinion-orphan-designation-35-diiodothyropropionic-acid-treatment-allan-herndon-dudley-syndrome_en.pdf"},
    {"id":"9016","name":"Scandonest Article-30 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-08-07T02:00:00Z","last_updated_date":"2018-08-07T02:00:00Z","reference_number":"EMA/413109/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/scandonest-article-30-referral-chmp-assessment-report_en.pdf"},
    {"id":"9018","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Divergent positions to CMDh position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-13T02:00:00Z","last_updated_date":"2013-06-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-divergent-positions-cmdh-position_en.pdf"},
    {"id":"9019","name":"Presentation - Working group on public - private partnership (Susan Tansey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-public-private-partnership-susan-tansey_en.pdf"},
    {"id":"9024","name":"CHMP summary of positive opinion for Bemfola","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-01-24T01:00:00Z","reference_number":"EMA/CHMP/41421/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bemfola_en.pdf"},
    {"id":"9025","name":"Final list of references supporting the assessment of Salvia fruticosa Mill., folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-07-01T02:00:00Z","last_updated_date":"2016-07-01T02:00:00Z","reference_number":"EMA/HMPC/440074/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-salvia-fruticosa-mill-folium_en.pdf"},
    {"id":"9026","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 14-17 November 2011","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T13:02:00Z","last_updated_date":"2011-11-18T13:02:00Z","reference_number":"EMA/905217/2011","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-14-17-november-2011_en.pdf"},
    {"id":"9027","name":"Annex B1 - Other criteria essential to ensure that EMA remains operational to guarantee business continuity – Summary of EMA contributions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T20:15:00Z","last_updated_date":"2017-10-03T20:15:00Z","reference_number":"EMA/606451/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annex-b1-other-criteria-essential-ensure-ema-remains-operational-guarantee-business-continuity-summary-ema-contributions_en.pdf"},
    {"id":"9028","name":"Committee for proprietary medicinal products February 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-03-01T01:00:00Z","last_updated_date":"2002-03-01T01:00:00Z","reference_number":"CPMP/590/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-february-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"9029","name":"Guideline on good pharmacovigilance practices: Module VII – Periodic safety update report with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-12-12T11:00:00Z","last_updated_date":"2013-12-12T11:00:00Z","reference_number":"EMA/816292/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-vii-periodic-safety-update-report-tracked-changes_en.pdf"},
    {"id":"9030","name":"Committee for medicinal products for human use  summary of positive opinion  for Xarelto","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/357818/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-xarelto_en.pdf"},
    {"id":"9031","name":"Presentation - Non-small cell lung cancer (NSCLC) regulatory – industry perspective (Catherine Weil) - S2.5","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-small-cell-lung-cancer-nsclc-regulatory-industry-perspective-catherine-weil-s25_en.pdf"},
    {"id":"9032","name":"Presentation - Lessons learned on scientific-ethical issues from the Task-force in Europe for Drug Development for the Young (TEDDY) survey among European ethics committees","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lessons-learned-scientific-ethical-issues-task-force-europe-drug-development-young-teddy-survey-among-european-ethics-committees_en.pdf"},
    {"id":"9033","name":"EU/3/01/020: Public summary of positive opinion for orphan designation of ibuprofen for the treatment of patent ductus arteriosus","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMEA/COMP/158/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301020-public-summary-positive-opinion-orphan-designation-ibuprofen-treatment-patent-ductus-arteriosus_en.pdf"},
    {"id":"9034","name":"Annexes - 2017 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T16:00:00Z","last_updated_date":"2018-05-02T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annexes-2017-annual-report-european-medicines-agency_en.pdf"},
    {"id":"9036","name":"Opinion of the CVMP on the establishment of maximum residue limits: Diclazuril","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-03-17T15:30:00Z","last_updated_date":"2014-03-17T15:30:00Z","reference_number":"EMA/CVMP/13722/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-diclazuril_en.pdf-0"},
    {"id":"9037","name":"CHMP Safety Working Party’s response to the PDCO regarding aluminium hydroxide contained in allergen products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2011-07-12T02:00:00Z","reference_number":"EMA/CHMP/381064/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/chmp-safety-working-partys-response-pdco-regarding-aluminium-hydroxide-contained-allergen-products_en.pdf"},
    {"id":"9038","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Ceftriaxone / sulbactam for treatment of bacterial infections","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T17:30:00Z","last_updated_date":"2015-05-19T17:30:00Z","reference_number":"EMA/281072/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-ceftriaxone-sulbactam-treatment-bacterial-infections_en.pdf"},
    {"id":"9039","name":"13th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-05-23T02:00:00Z","last_updated_date":"2001-05-23T02:00:00Z","reference_number":"COMP/199/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/13th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"9042","name":"Presentation - Key comments from the public consultation and the regulatory challenge (Armin Koch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-comments-public-consultation-and-regulatory-challenge-armin-koch_en.pdf"},
    {"id":"9043","name":"Withdrawal assessment report for Memantine FGK","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-04-10T02:00:00Z","last_updated_date":"2013-04-10T02:00:00Z","reference_number":"EMA/17269/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-memantine-fgk_en.pdf"},
    {"id":"9044","name":"Sandy everlasting: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"EMA/269745/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/sandy-everlasting-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/sandy-everlasting-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/sandy-everlasting-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/sandy-everlasting-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/sandy-everlasting-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/sandy-everlasting-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/sandy-everlasting-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/sandy-everlasting-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/sandy-everlasting-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/sandy-everlasting-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/sandy-everlasting-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/sandy-everlasting-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/sandy-everlasting-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/sandy-everlasting-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/sandy-everlasting-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/sandy-everlasting-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/sandy-everlasting-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/sandy-everlasting-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/sandy-everlasting-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/sandy-everlasting-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/sandy-everlasting-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/sandy-everlasting-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/sandy-everlasting-summary-public_sv.pdf"}},
    {"id":"9045","name":"Presentation - The value of Bayesian statistics for assessing comparability (T. Mutsvari, EFSPI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-value-bayesian-statistics-assessing-comparability-t-mutsvari-efspi_en.pdf"},
    {"id":"9046","name":"EU/3/04/212: Public summary of positive opinion for orphan designation of defibrotide for the treatment of hepatic veno-occlusive disease (VOD)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2013-11-11T12:00:00Z","reference_number":"EMEA/COMP/313/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304212-public-summary-positive-opinion-orphan-designation-defibrotide-treatment-hepatic-veno-occlusive-disease-vod_en.pdf"},
    {"id":"9048","name":"Porcimectin solution for injection Article-33 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2014-08-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/porcimectin-solution-injection-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"9050","name":"CVMP summary of positive opinion for Letifend","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-02-19T01:00:00Z","last_updated_date":"2016-02-19T01:00:00Z","reference_number":"EMA/CVMP/4233/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-letifend_en.pdf"},
    {"id":"9052","name":"CHMP summary of positive opinion for Fluenz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2014-12-03T01:00:00Z","reference_number":"EMA/CHMP/503333/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fluenz_en.pdf"},
    {"id":"9054","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Valaciclovir (hydrochloride) for treatment and prevention of Herpes simplex virus disease and treatment and prevention of Varicella Zoster vir...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T12:30:00Z","last_updated_date":"2015-02-17T12:30:00Z","reference_number":"EMA/99269/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-valaciclovir-hydrochloride-treatment-and-prevention-herpes-simplex-virus-disease-and-treatment-and-prevention-varicella-zoster-vir_en.pdf"},
    {"id":"9057","name":"Hydroxyethyl-starch solutions for infusion to be suspended – CMDh endorses PRAC recommendation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T01:00:00Z","last_updated_date":"2018-02-02T01:00:00Z","reference_number":"EMA/35795/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/hydroxyethyl-starch-solutions-infusion-be-suspended-cmdh-endorses-prac-recommendation_en.pdf"},
    {"id":"9058","name":"Committee for Proprietary Medicinal Products (CPMP) 36th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-03-27T00:00:00Z","last_updated_date":"1998-03-27T00:00:00Z","reference_number":"CPMP/438/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-36th-plenary-meeting_en.pdf"},
    {"id":"9061","name":"Presentation - Quality attributes impacting immunogenicity of therapeutic proteins (Steffen Gross)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-attributes-impacting-immunogenicity-therapeutic-proteins-steffen-gross_en.pdf"},
    {"id":"9062","name":"Minutes of the 74th meeting of the Management Board: 15 December 2011","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"EMA/MB/33634/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-74th-meeting-management-board-15-december-2011_sv.pdf"}},
    {"id":"9064","name":"Draft contract for external experts","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T12:00:00Z","last_updated_date":"2018-07-10T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/draft-contract-external-experts_en.pdf"},
    {"id":"9065","name":"VICH GL 45 quality: bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/CVMP/VICH/581467/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl-45-quality-bracketing-and-matrixing-designs-stability-testing-new-veterinary-drug-substances-and-medicinal-products_en.pdf"},
    {"id":"9067","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/228011/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf"},
    {"id":"9069","name":"Bituminosulfonates, ammonium and sodium salts (Extension to dairy cattle): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-09-01T02:00:00Z","last_updated_date":"2004-09-01T02:00:00Z","reference_number":"EMEA/MRL/910/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bituminosulfonates-ammonium-and-sodium-salts-extension-dairy-cattle-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9071","name":"Draft budget for 2010, presented to the Management Board on 10 December 2009","type":"other","status":"Draft","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMEA/MB/628139/2009","document_url":"https://www.ema.europa.eu/en/documents/other/draft-budget-2010-presented-management-board-10-december-2009_en.pdf"},
    {"id":"9072","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Solithromycin for treatment of bacterial pneumonia and treatment of\n\ngonococcal infection","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-25T12:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/674176/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-solithromycin-treatment-bacterial-pneumonia-and-treatment-gonococcal-infection_en.pdf"},
    {"id":"9073","name":"EU/3/16/1614: Public summary of opinion on orphan designation: Tolfenamic acid for the treatment of behavioural variant frontotemporal dementia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/75479/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161614-public-summary-opinion-orphan-designation-tolfenamic-acid-treatment-behavioural-variant-frontotemporal-dementia_en.pdf"},
    {"id":"9074","name":"Presentation - Off-target toxicity – a regulator's view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:56Z","last_updated_date":"2012-06-15T17:10:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-target-toxicity-regulators-view_en.pdf"},
    {"id":"9075","name":"Levosalbutamol, salbutamol : List of nationally authorised medicinal products - PSUSA/00010330/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-06T13:40:00Z","last_updated_date":"2017-10-06T13:42:54Z","reference_number":"EMA/662335/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/levosalbutamol-salbutamol-list-nationally-authorised-medicinal-products-psusa00010330201701_en.pdf"},
    {"id":"9076","name":"Note for guidance: Additional quality requirements for products intended for incorporation into animal feeding-stuffs (medicated pre-mixes)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1996-12-01T01:00:00Z","last_updated_date":"1996-12-01T01:00:00Z","reference_number":"EMEA/CVMP/080/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-additional-quality-requirements-products-intended-incorporation-animal-feeding-stuffs-medicated-pre-mixes_en.pdf"},
    {"id":"9080","name":"Superseded overview of comments received on Community herbal monograph on Orthosiphon stamineus Benth., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-05-30T02:00:00Z","last_updated_date":"2011-05-30T02:00:00Z","reference_number":"EMA/HMPC/143067/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-orthosiphon-stamineus-benth-folium_en.pdf"},
    {"id":"9082","name":"Questions and answers on vaccines for the pandemic (H1N1) 2009 ('swine flu')","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/601321/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-vaccines-pandemic-h1n1-2009-swine-flu_en.pdf"},
    {"id":"9085","name":"EU/3/16/1622: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 5 containing a B-domain deleted variant of human coagulation factor VIII gene for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"EMA/COMP/163486/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161622-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-5-containing-b-domain-deleted-variant-human-coagulation-factor-viii-gene-treatment-haemophilia_en.pdf"},
    {"id":"9088","name":"EU/3/08/560: Public summary of positive opinion for orphan designationof (-)-(2R)-3-(2-hydroxymethylindanyl-4-oxy)-phenyl-4,4,4-trifluorobutane-1-sulfonate for the treatment of moderate and severe closed traumatic brai...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2013-11-28T11:53:00Z","reference_number":"EMEA/COMP/449352/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308560-public-summary-positive-opinion-orphan-designationof-2r-3-2-hydroxymethylindanyl-4-oxy-phenyl-444-trifluorobutane-1-sulfonate-treatment-moderate-and-severe-closed-traumatic-brai_en.pdf"},
    {"id":"9090","name":"Agenda - Training session for patients and consumers involved in European Medicines Agency activities","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-11-13T01:00:00Z","last_updated_date":"2015-01-21T01:00:00Z","reference_number":"EMA/632556/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-patients-and-consumers-involved-european-medicines-agency-activities_en.pdf"},
    {"id":"9091","name":"CHMP post-authorisation summary of positive opinion for Voncento","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/CHMP/420571/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-voncento_en.pdf"},
    {"id":"9094","name":"EU/3/04/204: Public summary of positive opinion for orphan designation of aztreonam lysinate (inhalation use) for the treatment of gram negative bacterial lung infection in cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2019-10-16T02:00:00Z","reference_number":"EMEA/COMP/296/04 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304204-public-summary-positive-opinion-orphan-designation-aztreonam-lysinate-inhalation-use-treatment-gram-negative-bacterial-lung-infection-cystic-fibrosis_en.pdf"},
    {"id":"9096","name":"Presentation - Example summary of the risk management plan (RMP) for Intuniv (guanfacine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-example-summary-risk-management-plan-rmp-intuniv-guanfacine_en.pdf"},
    {"id":"9097","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Retinal pigment epithelium cells derived from human induced pluripotent stem cells","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-02-12T16:30:00Z","last_updated_date":"2014-02-12T16:30:00Z","reference_number":"EMA/75786/2014","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-retinal-pigment-epithelium-cells-derived-human-induced-pluripotent-stem-cells_en.pdf"},
    {"id":"9098","name":"CHMP post-authorisation summary of positive opinion for Votubia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/609118/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-votubia_en.pdf"},
    {"id":"9099","name":"Module 04 - Presentation - Specificities of products for veterinary use","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/module-04-presentation-specificities-products-veterinary-use_en.pdf"},
    {"id":"9100","name":"Questions and answers on the referral for Loratadine Sandoz 10 loratadine 10 mg tablets","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-05-29T02:08:21Z","last_updated_date":"2009-05-29T02:08:21Z","reference_number":"EMEA/321803/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets_en.pdf"},
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    {"id":"9103","name":"Withdrawal letter: Kyndrisa","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-06-22T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-kyndrisa_en.pdf"},
    {"id":"9104","name":"Presentation - Regulatory discussant: Rob Hemmings preliminary conclusions - Break-out session 4 theme 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-discussant-rob-hemmings-preliminary-conclusions-break-out-session-4-theme-3_en.pdf"},
    {"id":"9105","name":"Construction of new EMA building in Amsterdam on track","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-05-29T02:00:00Z","last_updated_date":"2018-05-29T02:00:00Z","reference_number":"EMA/355745/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/construction-new-ema-building-amsterdam-track_en.pdf"},
    {"id":"9106","name":"Extension of confidentiality arrangement between the United States Food and Drug Administration and the European Commission Enterprise and Industry Directorate-General and the European Medicines Agency to exchange regula...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-09-15T02:09:21Z","last_updated_date":"2005-09-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/extension-confidentiality-arrangement-between-united-states-food-and-drug-administration-and-european-commission-enterprise-and-industry-directorate-general-and-european-medicines-agency-exchange_en.pdf"},
    {"id":"9111","name":"Presentation - Personalised medicine challenges: hype or hope? (Marisa Papaluca, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-personalised-medicine-challenges-hype-or-hope-marisa-papaluca-ema_en.pdf"},
    {"id":"9112","name":"EU/3/06/382: Public summary of positive opinion for orphan designation of pazopanib hydrochloride for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-20T00:00:00Z","last_updated_date":"2011-06-01T01:00:00Z","reference_number":"EMEA/COMP/156129/2006draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306382-public-summary-positive-opinion-orphan-designation-pazopanib-hydrochloride-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"9113","name":"EU/3/14/1354: Public summary of opinion on orphan designation: Selinexor for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"EMA/COMP/637216/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141354-public-summary-opinion-orphan-designation-selinexor-treatment-chronic-lymphocytic-leukaemia-small-lymphocytic-lymphoma_en.pdf"},
    {"id":"9115","name":"Dyax s.a. withdraws its marketing authorisation application for Kalbitor (ecallantide)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T01:00:00Z","last_updated_date":"2011-11-15T01:00:00Z","reference_number":"EMA/891024/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/dyax-sa-withdraws-its-marketing-authorisation-application-kalbitor-ecallantide_en.pdf"},
    {"id":"9116","name":"EU/3/16/1746: Public summary of positive opinion for orphan designation of carbamazepine for the treatment of metaphyseal chondrodysplasia, Schmid type","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/623846/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161746-public-summary-positive-opinion-orphan-designation-carbamazepine-treatment-metaphyseal-chondrodysplasia-schmid-type_en.pdf"},
    {"id":"9124","name":"Abamectin (Revision of the acceptable daily intake): Summary Report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-05-01T02:00:00Z","last_updated_date":"2002-05-01T02:00:00Z","reference_number":"EMEA/MRL/838/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/abamectin-revision-acceptable-daily-intake-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9125","name":"Committee for medicinal products for human use, summary of positive opinion for  Vedrop","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/CHMP/282149/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-vedrop_en.pdf"},
    {"id":"9126","name":"GVK Biosciences review: some Member States suspend marketing authorisations for concerned medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/763052/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/gvk-biosciences-review-some-member-states-suspend-marketing-authorisations-concerned-medicines_en.pdf"},
    {"id":"9129","name":"Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-13T02:00:00Z","last_updated_date":"2016-10-18T10:40:10Z","reference_number":"EMA/6088686/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/lubiprostone-list-nationally-authorised-medicinal-products-psusa00010290201601_en.pdf"},
    {"id":"9130","name":"Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-07-22T02:00:00Z","last_updated_date":"2022-09-15T16:56:00Z","reference_number":"EMA/CVMP/PhVWP/10418/2009 Rev.13 Corr.","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/combined-veterinary-dictionary-drug-regulatory-activities-veddra-list-clinical-terms-reporting-suspected-adverse-reactions-animals-and-humans-veterinary-medicinal-products-excel_en.xls"},
    {"id":"9134","name":"Final list of references supporting the assessment of Filipendula ulmaria (L.) Maxim., herba and Filipendula ulmaria (L.) Maxim., flos - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2011-09-29T02:00:00Z","last_updated_date":"2011-09-29T02:00:00Z","reference_number":"EMA/HMPC/759656/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-filipendula-ulmaria-l-maxim-herba-and-filipendula-ulmaria-l-maxim-flos-first-version_en.pdf"},
    {"id":"9136","name":"Committee for Medicinal Products for Human Use (CHMP) - October 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-10-25T02:00:00Z","last_updated_date":"2007-10-25T02:00:00Z","reference_number":"EMEA/473066/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-october-2007-plenary-meeting-monthly-report_en.pdf"},
    {"id":"9138","name":"Numeta Article-107i procedure - Annex V","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-27T15:00:00Z","last_updated_date":"2013-09-27T15:00:00Z","reference_number":"EMEA/H/A-107i/1373","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-annex-v_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/numeta-article-107i-procedure-annex-v_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/numeta-article-107i-procedure-annex-v_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/numeta-article-107i-procedure-annex-v_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/numeta-article-107i-procedure-annex-v_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/numeta-article-107i-procedure-annex-v_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/numeta-article-107i-procedure-annex-v_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/numeta-article-107i-procedure-annex-v_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/numeta-article-107i-procedure-annex-v_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/numeta-article-107i-procedure-annex-v_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/numeta-article-107i-procedure-annex-v_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/numeta-article-107i-procedure-annex-v_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/numeta-article-107i-procedure-annex-v_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/numeta-article-107i-procedure-annex-v_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/numeta-article-107i-procedure-annex-v_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/numeta-article-107i-procedure-annex-v_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/numeta-article-107i-procedure-annex-v_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/numeta-article-107i-procedure-annex-v_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/numeta-article-107i-procedure-annex-v_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/numeta-article-107i-procedure-annex-v_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/numeta-article-107i-procedure-annex-v_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/numeta-article-107i-procedure-annex-v_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/numeta-article-107i-procedure-annex-v_sv.pdf"}},
    {"id":"9140","name":"Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-11T18:41:00Z","last_updated_date":"2018-09-11T18:43:00Z","reference_number":"EMA/615391/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/tobramycin-nebuliser-solution-apart-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa00009316201712_en.pdf"},
    {"id":"9141","name":"Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-11-18T01:00:00Z","last_updated_date":"2016-11-18T01:00:00Z","reference_number":"EMA/CHMP/707532/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paediatric-addendum-chmp-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure_en.pdf"},
    {"id":"9142","name":"EU/3/09/643: Public summary of positive opinion for orphan designation of desipramine chlorhydrate for the treatment of Rett syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2017-08-16T02:00:00Z","reference_number":"EMEA/COMP/295146/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309643-public-summary-positive-opinion-orphan-designation-desipramine-chlorhydrate-treatment-rett-syndrome_en.pdf"},
    {"id":"9143","name":"Presentation - Acquis communautaire: Perspectives for regulators","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-acquis-communautaire-perspectives-regulators_en.pdf"},
    {"id":"9146","name":"Announcement - European Medicines Agency/International Federation for Animal Health Europe info day 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-02T17:00:00Z","last_updated_date":"2015-12-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/announcement-european-medicines-agencyinternational-federation-animal-health-europe-info-day-2016_en.pdf"},
    {"id":"9147","name":"CHMP summary of positive opinion for Segluromet","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-01-26T13:00:00Z","reference_number":"EMA/CHMP/12790/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-segluromet_en.pdf"},
    {"id":"9148","name":"Superseded overview of comments received on 'Community herbal monograph on Cassia senna L., fructus and Cassia angustifolia Vahl, fructus' (EMEA/HMPC/51871/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2007-04-27T02:09:00Z","last_updated_date":"2007-04-27T02:09:00Z","reference_number":"EMEA/HMPC/237716/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-cassia-senna-l-fructus-and-cassia-angustifolia-vahl-fructus-emeahmpc518712006_en.pdf"},
    {"id":"9154","name":"Presentation - How patients are involved in the review of documents","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-31T19:00:00Z","last_updated_date":"2016-08-31T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patients-are-involved-review-documents_en.pdf"},
    {"id":"9159","name":"Committee for medicinal products for veterinary use: Meeting of 13 - 15 March 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-03-16T12:09:21Z","last_updated_date":"2007-03-16T12:09:21Z","reference_number":"EMEA/CVMP/94094/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-13-15-march-2007_en.pdf"},
    {"id":"9161","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Invega","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/2672/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-invega_sv.pdf"}},
    {"id":"9162","name":"Minutes of the European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations meeting: Election of co-chair","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-12-11T10:30:00Z","last_updated_date":"2013-12-11T10:30:00Z","reference_number":"EMA/696950/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-meeting-election-co-chair_en.pdf"},
    {"id":"9164","name":"EU/3/10/842: Public summary of opinion on orphan designation: Nimorazole for the treatment of squamous cell carcinoma of the head and neck in patients undergoing radiotherapy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2011-03-04T01:00:00Z","reference_number":"EMA/COMP/740415/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310842-public-summary-opinion-orphan-designation-nimorazole-treatment-squamous-cell-carcinoma-head-and-neck-patients-undergoing-radiotherapy_en.pdf"},
    {"id":"9167","name":"How Modified PEM supports Risk Management: a selected brief overview - S. Shakir","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/how-modified-pem-supports-risk-management-selected-brief-overview-s-shakir_en.pdf"},
    {"id":"9168","name":"CHMP post-authorisation summary of positive opinion for Ozurdex","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/430193/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ozurdex_en.pdf"},
    {"id":"9169","name":"Development of Off-patent Medicines for Paediatric Use: Generic Industry Perspective - Michael Banks","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-06T02:09:21Z","last_updated_date":"2007-06-06T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/development-patent-medicines-paediatric-use-generic-industry-perspective-michael-banks_en.pdf"},
    {"id":"9171","name":"Committee for Orphan Medicinal Products (COMP) meetings 2019, 2020 and 2021","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-29T12:25:00Z","last_updated_date":"2019-07-31T13:25:00Z","reference_number":"EMA/COMP/115244/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/committee-orphan-medicinal-products-comp-meetings-2019-2020-and-2021_en.pdf"},
    {"id":"9172","name":"Summary of the European Union workshop on ICH Q3D from a quality perspective","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-03-08T13:00:00Z","last_updated_date":"2016-03-08T13:00:00Z","reference_number":"EMA/INS/158905/2016","document_url":"https://www.ema.europa.eu/en/documents/other/summary-european-union-workshop-ich-q3d-quality-perspective_en.pdf"},
    {"id":"9174","name":"Final Community herbal monograph on Rubus idaeus L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T11:00:00Z","last_updated_date":"2014-03-21T11:00:00Z","reference_number":"EMA/HMPC/44211/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-rubus-idaeus-l-folium_en.pdf"},
    {"id":"9176","name":"Ticagrelor film-coated tablets 90mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-11-01T17:39:13Z","reference_number":"EMA/CHMP/177281/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ticagrelor-film-coated-tablets-90mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"9177","name":"Package leaflet: information for the patient: Fludeoxyglucose","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-14T01:00:00Z","last_updated_date":"2010-12-14T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/package-leaflet-information-patient-fludeoxyglucose_en.pdf"},
    {"id":"9181","name":"Toltrazuril: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"2019-11-27T13:40:00Z","reference_number":"EMEA/MRL/314/97 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/toltrazuril-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9184","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Bosulif (bosutinib) for the treatment chronic myeloid leukaemia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2013-04-11T02:00:00Z","last_updated_date":"2013-04-11T02:00:00Z","reference_number":"EMA/COMP/71582/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-bosulif-bosutinib-treatment-chronic-myeloid-leukaemia_en.pdf"},
    {"id":"9185","name":"Presentation - Outcome of Federation of Veterinarians of Europe (FVE) survey on adverse event reporting","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outcome-federation-veterinarians-europe-fve-survey-adverse-event-reporting_en.pdf"},
    {"id":"9188","name":"Availability of medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-01-20T01:00:00Z","last_updated_date":"1999-01-20T01:00:00Z","reference_number":"EMEA/V2381/99","document_url":"https://www.ema.europa.eu/en/documents/other/availability-medicines_en.pdf"},
    {"id":"9190","name":"CHMP summary of positive opinion for Ristfor","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMEA/CHMP/771707/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ristfor_en.pdf"},
    {"id":"9191","name":"Presentation - Module 11 - International cooperation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-11-international-cooperation_en.pdf"},
    {"id":"9196","name":"Presentation - European Medicines Agency (EMA) on social media- EMA's PCWP and HCPWP joint meeting (Monika Benstetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-ema-social-media-emas-pcwp-and-hcpwp-joint-meeting-monika-benstetter_en.pdf"},
    {"id":"9197","name":"Draft community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-01-14T00:09:21Z","last_updated_date":"2009-01-14T00:09:21Z","reference_number":"EMEA/HMPC/212895/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf"},
    {"id":"9200","name":"Exametazime / technetium (99mTc) exametazime: List of nationally authorised medicinal products - PSUSA/00001344/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T19:35:00Z","last_updated_date":"2016-10-19T19:35:00Z","reference_number":"EMA/662405/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/exametazime-technetium-99mtc-exametazime-list-nationally-authorised-medicinal-products-psusa00001344201601_en.pdf"},
    {"id":"9201","name":"Conventional medicinal products: Full applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-25T01:09:21Z","last_updated_date":"2009-12-03T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/conventional-medicinal-products-full-applications_en.pdf"},
    {"id":"9202","name":"Superseded community herbal monograph on Ribes nigrum L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-06-30T02:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"EMA/HMPC/142986/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-ribes-nigrum-l-folium_en.pdf"},
    {"id":"9203","name":"Benzalkonium chloride used as an excipient - \n\nReport published in support of the ‘Questions and answers on benzalkonium chloride used as an excipient in medicinal products for human use’","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/352187/2012","document_url":"https://www.ema.europa.eu/en/documents/report/benzalkonium-chloride-used-excipient-report-published-support-questions-and-answers-benzalkonium-chloride-used-excipient-medicinal-products-human-use_en.pdf"},
    {"id":"9207","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: International BFM Study Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-international-bfm-study-group_en.pdf"},
    {"id":"9209","name":"Public statement on Provenge: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/303072/2015","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-provenge-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"9210","name":"Nanotop Article-29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-16T17:00:00Z","last_updated_date":"2014-06-16T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nanotop-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nanotop-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nanotop-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nanotop-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nanotop-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nanotop-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nanotop-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nanotop-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nanotop-article-294-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nanotop-article-294-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nanotop-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nanotop-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nanotop-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nanotop-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nanotop-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nanotop-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nanotop-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nanotop-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nanotop-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nanotop-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nanotop-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nanotop-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nanotop-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"9212","name":"Questions and answers on positive opinion on the marketing authorisation for Fampyra (fampridine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/395076/2011 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-positive-opinion-marketing-authorisation-fampyra-fampridine_en.pdf"},
    {"id":"9214","name":"Annual accounts: Financial year 2007","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-11-24T00:09:21Z","last_updated_date":"2009-11-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/annual-accounts-financial-year-2007_en.pdf"},
    {"id":"9215","name":"Scientific recommendation on classification of advanced therapy medicinal products: Adeno-Associated Viral Vectors derived from wild-type AAV2/5. The expression cassettes contain DNA encoding an RNA interference (RNAi) s...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:00:00Z","last_updated_date":"2015-08-26T12:00:00Z","reference_number":"EMA/557237/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adeno-associated-viral-vectors-derived-wild-type-aav25-expression-cassettes-contain-dna-encoding-rna-interference-rnai-s_en.pdf"},
    {"id":"9216","name":"Presentation - Progress update: CMDv/Industry Joint Task Force on variations (Kevin Yount)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-progress-update-cmdvindustry-joint-task-force-variations-kevin-yount_en.pdf"},
    {"id":"9217","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the July 2011 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-07-20T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/COMP/399953/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-july-2011-meeting_en.pdf"},
    {"id":"9218","name":"Working party on Herbal Medicinal Products: Draft proposal for a core data for Hop Strobile","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2000-03-31T02:00:00Z","last_updated_date":"2000-03-31T02:00:00Z","reference_number":"EMEA/HMPWP/20/00","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-draft-proposal-core-data-hop-strobile_en.pdf"},
    {"id":"9219","name":"Biperiden : List of nationally authorised medicinal products - PSUSA/00000415/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-15T12:26:00Z","last_updated_date":"2017-05-15T12:28:16Z","reference_number":"EMA/302920/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/biperiden-list-nationally-authorised-medicinal-products-psusa00000415201608_en.pdf"},
    {"id":"9220","name":"Committee for medicinal products for human use summary of positive opinion for Firmagon","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T00:09:21Z","last_updated_date":"2008-12-18T00:09:21Z","reference_number":"EMEA/CHMP/667162/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-firmagon_en.pdf"},
    {"id":"9221","name":"Presentation - HMPC feedback (Steffen Bager)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hmpc-feedback-steffen-bager_en.pdf"},
    {"id":"9222","name":"Presentation - Update from the CVMP's Environmental Risk Assessment Working Party: Assessment of veterinary medicinal products (VMPs) containing persistent, bioaccumulative and toxic substances (PBTs) (Boris Kolar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-cvmps-environmental-risk-assessment-working-party-assessment-veterinary-medicinal-products-vmps-containing-persistent-bioaccumulative-and-toxic-substances-pbts-boris-kolar_en.pdf"},
    {"id":"9223","name":"Application form for the establishment of maximum-residue-limits for an active substance to be used in veterinary medicinal products in accordance with Regulation (EC) No. 470/2009","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-04-26T15:25:00Z","last_updated_date":"2018-08-31T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-form-establishment-maximum-residue-limits-active-substance-be-used-veterinary-medicinal-products-accordance-regulation-ec-no-4702009_en.pdf"},
    {"id":"9225","name":"Dicyclanil (Modification of the MRL for fat): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-05-01T02:00:00Z","last_updated_date":"2000-05-01T02:00:00Z","reference_number":"EMEA/MRL/739/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dicyclanil-modification-mrl-fat-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9228","name":"Presentation - Classification of advanced-therapy medicinal products (Egbert Flory)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T02:00:00Z","last_updated_date":"2014-10-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-classification-advanced-therapy-medicinal-products-egbert-flory_en.pdf"},
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    {"id":"9235","name":"Draft guideline on data requirements to support in-use stability claims for veterinary vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2009-03-16T01:00:00Z","reference_number":"EMEA/CVMP/IWP/250147/2008-CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-support-use-stability-claims-veterinary-vaccines_en.pdf"},
    {"id":"9238","name":"List of participants - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (27 June 2017)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"EMA/258524/2017","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-27-june-2017_en.pdf"},
    {"id":"9239","name":"Final assessment report on Serenoa repens (W. Bartram) Small, fructus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-03-30T02:00:00Z","last_updated_date":"2016-03-30T02:00:00Z","reference_number":"EMA/HMPC/137250/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"9241","name":"European Medicines Agency recommendation on use of angiotensin II receptor antagonists during pregnancy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/206061/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommendation-use-angiotensin-ii-receptor-antagonists-during-pregnancy_en.pdf"},
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    {"id":"9247","name":"Note for guidance: DNA vaccines non-amplifiable in eukaryotic cells for veterinary use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"CVMP/IWP/07/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-dna-vaccines-non-amplifiable-eukaryotic-cells-veterinary-use_en.pdf"},
    {"id":"9248","name":"Interaction with stakeholders communication, J Garcia, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/interaction-stakeholders-communication-j-garcia-ema_en.pdf"},
    {"id":"9251","name":"Draft assessment report on Helichrysum arenarium (L.) Moench, flos","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-10-14T12:35:00Z","last_updated_date":"2015-10-14T12:35:00Z","reference_number":"EMA/HMPC/41109/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-helichrysum-arenarium-l-moench-flos_en.pdf"},
    {"id":"9253","name":"Day 180 list of outstanding issues template rev. 10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-09-01T02:09:21Z","last_updated_date":"2016-11-08T17:25:00Z","reference_number":"Rev. 3.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-180-list-outstanding-issues-template-rev-1016_en.doc"},
    {"id":"9256","name":"Superseded list of references supporting the assessment of Hedera helix L., folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T01:00:00Z","last_updated_date":"2016-01-18T01:00:00Z","reference_number":"EMA/HMPC/289429/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-hedera-helix-l-folium_en.pdf"},
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    {"id":"9263","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-06-09T17:47:00Z","last_updated_date":"2015-06-09T17:47:00Z","reference_number":"EMA/308423/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-may-2015_en.pdf"},
    {"id":"9264","name":"Initial notices for parallel distribution – March 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-04-22T14:30:00Z","last_updated_date":"2014-04-22T14:30:00Z","reference_number":"EMA/227993/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-march-2014_en.pdf"},
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    {"id":"9268","name":"EU/3/01/035: Public summary of positive opinion for orphan designation of levodopa / carbidopa (gastroenteral use) for the treatment of advanced idiopathic Parkinson’s disease with severe motor fluctuations and not respo...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-03T00:00:00Z","last_updated_date":"2016-01-19T12:00:00Z","reference_number":"EMEA/COMP/197/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301035-public-summary-positive-opinion-orphan-designation-levodopa-carbidopa-gastroenteral-use-treatment-advanced-idiopathic-parkinsons-disease-severe-motor-fluctuations-and-not-respo_en.pdf"},
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    {"id":"9275","name":"Presentation - Rare diseases, European and UK approaches: setting the scene (Julian Thomas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rare-diseases-european-and-uk-approaches-setting-scene-julian-thomas_en.pdf"},
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    {"id":"9277","name":"Sortis-EMEA/H/A-29 PAD/1255: Article 29 Paediatrics referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-04-27T02:00:00Z","last_updated_date":"2011-04-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sortis-emeaha-29-pad1255-article-29-paediatrics-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"9278","name":"Agenda - PRAC draft agenda of meeting 9-12 January 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-01-09T14:55:00Z","last_updated_date":"2017-01-09T14:55:00Z","reference_number":"EMA/PRAC/816784/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-9-12-january-2017_en.pdf"},
    {"id":"9280","name":"EU/3/05/271: Public summary of positive opinion for orphan designation of paromomycin sulfate for the treatment of visceral leishmaniasis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2011-05-19T01:00:00Z","reference_number":"EMEA/COMP/131770/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305271-public-summary-positive-opinion-orphan-designation-paromomycin-sulfate-treatment-visceral-leishmaniasis_en.pdf"},
    {"id":"9281","name":"Presentation - ClinicoBru The Brussels clinical trial network (Florence Bosco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinicobru-brussels-clinical-trial-network-florence-bosco_en.pdf"},
    {"id":"9283","name":"Opinion of the CVMP on the establishment of maximum residue limits: Phenoxymethylpenicillin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-03-22T01:00:00Z","last_updated_date":"2012-03-22T01:00:00Z","reference_number":"EMA/CVMP/447493/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-phenoxymethylpenicillin_en.pdf"},
    {"id":"9284","name":"Moxidectin Article-35 referral - Questions and answers on the environmental impact of moxidectin-containing veterinary medicines used in cattle, sheep and 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    {"id":"9285","name":"Committee for medicinal products for veterinary use summary of opinion: Suvaxyn PCV: International Non-proprietary Names (INN): Gamithromycin","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T03:09:00Z","last_updated_date":"2020-04-15T03:09:00Z","reference_number":"EMEA/CVMP/257211/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-suvaxyn-pcv-international-non-proprietary-names-inn-gamithromycin_en.pdf"},
    {"id":"9286","name":"EU/3/06/387: Public summary of positive opinion for orphan designation of amikacin sulfate (liposomal) for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMEA/COMP/428207/2006 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306387-public-summary-positive-opinion-orphan-designation-amikacin-sulfate-liposomal-treatment-pseudomonas-aeruginosa-lung-infection-cystic-fibrosis_en.pdf"},
    {"id":"9287","name":"Presentation - Academic perspective (Marie L De Bruin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-29T18:30:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-academic-perspective-marie-l-de-bruin_en.pdf"},
    {"id":"9289","name":"CHMP post-authorisation summary of positive opinion for Optisulin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T02:00:00Z","last_updated_date":"2012-04-20T02:00:00Z","reference_number":"EMA/CHMP/184676/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-optisulin_en.pdf"},
    {"id":"9292","name":"Presentation - How to weigh the strength of prior information and clarify the expected level of evidence? (M. Posch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-weigh-strength-prior-information-and-clarify-expected-level-evidence-m-posch_en.pdf"},
    {"id":"9293","name":"Last meeting of the working party on herbal medicinal products: 3-4 June 2004, EMEA London","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2004-06-24T14:09:21Z","last_updated_date":"2004-06-24T14:09:21Z","reference_number":"EMEA/CHMP/HMPWP/3/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/last-meeting-working-party-herbal-medicinal-products-3-4-june-2004-emea-london_en.pdf"},
    {"id":"9294","name":"Overview of comments received on 'Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T15:45:00Z","last_updated_date":"2014-02-20T16:25:00Z","reference_number":"EMA/CVMP/AWP/257904/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-use-pleuromutilins-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"9295","name":"European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-12-22T17:00:00Z","last_updated_date":"2011-12-22T17:00:00Z","reference_number":"EMA/CHMP/989693/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-aliskiren-containing-medicines-following-termination-altitude-study_en.pdf"},
    {"id":"9298","name":"CHMP summary of positive opinion for Granpidam","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/592404/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-granpidam_en.pdf"},
    {"id":"9299","name":"EU/3/01/066: Public summary of positive opinion for orphan designation of thalidomide for the treatment of erythema nodosum lepra or type II lepra reactions.","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-20T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/1287/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301066-public-summary-positive-opinion-orphan-designation-thalidomide-treatment-erythema-nodosum-lepra-or-type-ii-lepra-reactions_en.pdf"},
    {"id":"9300","name":"Work plan for the Pharmacovigilance Inspectors Working Group for 2014","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2014-05-22T16:55:00Z","last_updated_date":"2014-05-22T16:55:00Z","reference_number":"EMA/INS/PhV/555137/2013","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-pharmacovigilance-inspectors-working-group-2014_en.pdf"},
    {"id":"9301","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the May 2011 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-06T02:00:00Z","last_updated_date":"2011-05-06T02:00:00Z","reference_number":"EMA/COMP/135191/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-may-2011-meeting_en.pdf"},
    {"id":"9302","name":"CHMP summary of positive opinion for Varuby","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T11:00:00Z","last_updated_date":"2020-03-02T11:00:00Z","reference_number":"EMA/CHMP/97358/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-varuby_en.pdf"},
    {"id":"9303","name":"European Medicines Agency confirms positive benefit-risk balance of Rotarix","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/CHMP/462029/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-confirms-positive-benefit-risk-balance-rotarix_en.pdf"},
    {"id":"9304","name":"Presentation - European Union collaborative framework for patient registries (Jacoline Bouvy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-union-collaborative-framework-patient-registries-jacoline-bouvy_en.pdf"},
    {"id":"9305","name":"Committee for proprietary medicinal products December 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-01-06T01:00:00Z","last_updated_date":"2003-01-06T01:00:00Z","reference_number":"EMEA/CPMP/6248/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-december-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"9307","name":"CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-advice-european-medicines-agency-rules-engagement-accessing-clinical-trial-data-draft-22-march-2013-version-70_en.pdf"},
    {"id":"9311","name":"EU/3/05/276 - Public summary of positive opinion for orphan designation of humanised agonistic anti-CD28 monoclonal antibody for the treatment of B-cell chronic lymphocytic leukemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2005-07-01T02:00:00Z","reference_number":"EMEA/COMP/85958/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305276-public-summary-positive-opinion-orphan-designation-humanised-agonistic-anti-cd28-monoclonal-antibody-treatment-b-cell-chronic-lymphocytic-leukemia_en.pdf"},
    {"id":"9312","name":"Presentation - Geriatrician’s perspective on implementation of the new pharmacovigilance legislation (Jean-Pierre Baeyens)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-geriatricians-perspective-implementation-new-pharmacovigilance-legislation-jean-pierre-baeyens_en.pdf"},
    {"id":"9313","name":"CHMP summary of positive opinion for Sprimeo HCT","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-02-17T01:00:00Z","last_updated_date":"2012-08-28T02:00:00Z","reference_number":"EMA/124454/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sprimeo-hct_en.pdf"},
    {"id":"9314","name":"Presentation - Determining the predicative ability of in vitro microphysiological systems to answer critical regulatory questions (S. Fitzpatrick)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T10:54:00Z","last_updated_date":"2017-11-15T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-determining-predicative-ability-vitro-microphysiological-systems-answer-critical-regulatory-questions-s-fitzpatrick_en.pdf"},
    {"id":"9315","name":"Summary information on a referral opinion following an arbitration pursuant to Article 18 of Council Directive 81/851/EECc as amended for Avinew: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-01-02T00:59:00Z","last_updated_date":"2002-01-02T00:59:00Z","reference_number":"CVMP/1129/01","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-18-council-directive-81851eecc-amended-avinew-background-information_en.pdf"},
    {"id":"9318","name":"Public statement on Onduarp: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-04-02T16:00:00Z","last_updated_date":"2014-04-02T16:00:00Z","reference_number":"EMA/133999/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-onduarp-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"9319","name":"Acetylsalicylic acid statement translation","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-04-02T01:31:00Z","last_updated_date":"2011-04-02T01:31:00Z","reference_number":"EMA/18570/2003","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/acetylsalicylic-acid-statement-translation_en.pdf"},
    {"id":"9320","name":"EU/3/17/1962: Public summary of opinion on orphan designation: Humanised Fc-engineered monoclonal antibody against CD19 for the treatment of IgG4-related disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/828791/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171962-public-summary-opinion-orphan-designation-humanised-fc-engineered-monoclonal-antibody-against-cd19-treatment-igg4-related-disease_en.pdf"},
    {"id":"9321","name":"Teicoplanin hospira - Article 29 referral - Annex I, II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/teicoplanin-hospira-article-29-referral-annex-i-ii_sv.pdf"}},
    {"id":"9322","name":"EU/3/16/1761: Public summary of positive opinion for orphan designation of self-complementary adeno-associated viral vector serotype 9 containing the SGSH gene for the treatment of mucopolysaccharidosis type IIIA (Sanfil...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/629533/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161761-public-summary-positive-opinion-orphan-designation-self-complementary-adeno-associated-viral-vector-serotype-9-containing-sgsh-gene-treatment-mucopolysaccharidosis-type-iiia-sanfil_en.pdf"},
    {"id":"9324","name":"Concept paper on higher tier testing of antiparasitics to dung organisms","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/CVMP/ERA/12254/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-higher-tier-testing-antiparasitics-dung-organisms_en.pdf"},
    {"id":"9326","name":"Fosfomycin (IV formulation): List of nationally authorised medicinal products - PSUSA/00010336/201607","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2017-04-11T19:40:00Z","last_updated_date":"2017-04-11T19:40:00Z","reference_number":"EMA/235643/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/fosfomycin-iv-formulation-list-nationally-authorised-medicinal-products-psusa00010336201607_en.pdf"},
    {"id":"9327","name":"Withdrawal assessment report for Garenoxacin mesylate","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/CHMP/363573/2007","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-garenoxacin-mesylate_en.pdf"},
    {"id":"9329","name":"Guideline on similar biological medicinal products (Rev.1)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-10-29T15:30:00Z","last_updated_date":"2014-10-29T15:30:00Z","reference_number":"CHMP/437/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf"},
    {"id":"9330","name":"Call for submission of scientific data relating to the assessment of Agni casti fructus Vitex agnus-castus L., fructus (agnus castus fruit) - First version","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2008-11-15T01:00:00Z","last_updated_date":"2008-11-15T01:00:00Z","reference_number":"EMEA/HMPC/617265/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-agni-casti-fructus-vitex-agnus-castus-l-fructus-agnus-castus-fruit-first-version_en.pdf"},
    {"id":"9331","name":"Questions and answers on Docetaxel Teva Generics (docetaxel, 20 mg and 80 mg powder and solvent for solution for infusion)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-02-18T01:00:00Z","last_updated_date":"2012-07-03T02:00:00Z","reference_number":"EMEA/H/A-29/1277","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-docetaxel-teva-generics-docetaxel-20-mg-and-80-mg-powder-and-solvent-solution-infusion_sv.pdf"}},
    {"id":"9334","name":"Teva Pharma B.V. withdraws its marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel hydrobromide)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/251627/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/teva-pharma-bv-withdraws-its-marketing-authorisation-application-clopidogrel-teva-pharma-clopidogrel-hydrobromide_en.pdf"},
    {"id":"9336","name":"European Medicines Agency recommends approval of first vaccine for meningitis B","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"EMA/CHMP/728052/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-first-vaccine-meningitis-b_en.pdf"},
    {"id":"9339","name":"Technetium 99mtc sestamibi: List of nationally authorised medicinal products - PSUSA/00002868/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T16:40:00Z","last_updated_date":"2018-02-09T16:40:00Z","reference_number":"EMA/46903/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/technetium-99mtc-sestamibi-list-nationally-authorised-medicinal-products-psusa00002868201706_en.pdf"},
    {"id":"9340","name":"Annex to the European Medicines Agency master data management roadmap","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T16:00:00Z","last_updated_date":"2015-04-29T16:00:00Z","reference_number":"EMA/187520/2015","document_url":"https://www.ema.europa.eu/en/documents/other/annex-european-medicines-agency-master-data-management-roadmap_en.pdf"},
    {"id":"9343","name":"EU/3/09/721: Public summary of opinion on orphan designation of panobinostat for the treatment of Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2015-02-11T12:13:00Z","reference_number":"EMA/COMP/817766/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309721-public-summary-opinion-orphan-designation-panobinostat-treatment-hodgkins-lymphoma_en.pdf"},
    {"id":"9344","name":"Guideline on clinical evaluation of new vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-10-18T02:00:00Z","last_updated_date":"2006-10-18T02:00:00Z","reference_number":"EMEA/CHMP/VWP/164653/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-new-vaccines_en.pdf"},
    {"id":"9345","name":"Presentation - United Kingdom's withdrawal from the European Union (Olga Solomon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T02:00:00Z","last_updated_date":"2018-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-united-kingdoms-withdrawal-european-union-olga-solomon_en.pdf"},
    {"id":"9346","name":"Presentation - Opening remarks: EMA workshop on the collaboration with general practitioners/family physicians (Guido Rasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T02:00:00Z","last_updated_date":"2016-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opening-remarks-ema-workshop-collaboration-general-practitionersfamily-physicians-guido-rasi_en.pdf"},
    {"id":"9351","name":"CHMP summary of opinion for Epclusa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T14:00:00Z","last_updated_date":"2016-05-27T14:00:00Z","reference_number":"EMA/CHMP/323098/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-epclusa_en.pdf"},
    {"id":"9352","name":"Final opinion of the HMPC on a European Union herbal monograph on Artemisia absinthium L., herba - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-10-05T02:00:00Z","last_updated_date":"2017-10-05T02:00:00Z","reference_number":"EMA/HMPC/319051/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-artemisia-absinthium-l-herba-revision-1_en.pdf"},
    {"id":"9356","name":"CHMP elects new chair and vice-chair at its first meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/15117/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/chmp-elects-new-chair-and-vice-chair-its-first-meeting_en.pdf"},
    {"id":"9358","name":"Presentation - Module 6 - EMA support to innovation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-6-ema-support-innovation_en.pdf"},
    {"id":"9359","name":"Combined hormonal contraceptives Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"9360","name":"Presentation - Modelling and simulation to support evaluation of safety and efficacy of drugs in older patients","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-support-evaluation-safety-and-efficacy-drugs-older-patients_en.pdf"},
    {"id":"9361","name":"Working party on Herbal Medicinal Products: Comments on the European Commission guideline on dossier requirements for Type I Variations – Notice to Applicants Vol. 2A","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/HMPWP/22/99","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-comments-european-commission-guideline-dossier-requirements-type-i-variations-notice-applicants-vol-2a_en.pdf"},
    {"id":"9362","name":"IFAH-Europe conference room document: Outcomes of the evaluation of the European medicines agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ifah-europe-conference-room-document-outcomes-evaluation-european-medicines-agency_en.pdf"},
    {"id":"9363","name":"EU/3/15/1584: Public summary of opinion on orphan designation: Variant of recombinant human fibroblast growth factor 19 for the treatment of primary sclerosing cholangitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/COMP/791407/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151584-public-summary-opinion-orphan-designation-variant-recombinant-human-fibroblast-growth-factor-19-treatment-primary-sclerosing-cholangitis_en.pdf"},
    {"id":"9364","name":"Withdrawal assessment report for Plivensia","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2018-02-05T17:03:00Z","last_updated_date":"2018-02-05T17:03:00Z","reference_number":"EMA/CHMP/576037/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-plivensia_en.pdf"},
    {"id":"9365","name":"Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T14:10:13Z","last_updated_date":"2013-10-25T14:10:13Z","reference_number":"EMA/640658/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/hydroxyethyl-starch-solutions-hes-should-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients-cmdh-endorses-prac-recommendations_en.pdf"},
    {"id":"9366","name":"Presentation - Signal detection and management (G. Genov)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-signal-detection-and-management-g-genov_en.pdf"},
    {"id":"9367","name":"PDCO meeting highlights 24-26 June 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"EMEA/PDCO/386750/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-24-26-june-2009_en.pdf"},
    {"id":"9369","name":"Micro Therapeutic Research Article-31 referral - Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à -vis the EU reference medicinal product has been est...","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-04-19T02:00:00Z","reference_number":"EMA/203429/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-medicinal-products-recommended-maintenance-and-marketing-authorisation-applications-which-bioequivalence-vis-vis-eu-reference-medicinal-product-has-been_en.pdf"},
    {"id":"9372","name":"Appointment and responsibilities of rapporteur and co-rapporteur for procedures regarding veterinary medicinal products","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-01-01T01:00:00Z","last_updated_date":"2005-01-01T01:00:00Z","reference_number":"EMEA/CVMP/928/02-Revision FINAL","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/appointment-and-responsibilities-rapporteur-and-co-rapporteur-procedures-regarding-veterinary-medicinal-products_en.pdf"},
    {"id":"9374","name":"Hemoblast Bellows - Procedural steps and scientific information after initial consultation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-01T18:00:00Z","last_updated_date":"2021-03-15T10:20:00Z","reference_number":"EMA/CHMP/154036/2021 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/hemoblast-bellows-procedural-steps-and-scientific-information-after-initial-consultation_en.pdf"},
    {"id":"9377","name":"Ranitidine: List of nationally authorised medicinal products - PSUSA/00002610/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-22T11:00:00Z","last_updated_date":"2016-10-17T19:46:20Z","reference_number":"EMA/51946/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ranitidine-list-nationally-authorised-medicinal-products-psusa00002610201505_en.pdf"},
    {"id":"9378","name":"Ethics of Clinical Trials in Children - F Hirsch, P Zilgalvis, M Fitzgerald, E Pauwels","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-06T02:09:21Z","last_updated_date":"2007-06-06T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ethics-clinical-trials-children-f-hirsch-p-zilgalvis-m-fitzgerald-e-pauwels_en.pdf"},
    {"id":"9379","name":"Questions and answers on withdrawal of marketing application for Retaane","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-03-23T01:00:00Z","last_updated_date":"2006-03-23T01:00:00Z","reference_number":"EMEA/98712/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-retaane_sv.pdf"}},
    {"id":"9380","name":"Presentation - Day 1: Gene and molecular therapy; an industry view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-1-gene-and-molecular-therapy-industry-view_en.pdf"},
    {"id":"9382","name":"EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-22T20:55:00Z","last_updated_date":"2014-10-22T20:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-ready-start-assessment-ebola-vaccines-and-treatments-soon-data-are-made-available_en.pdf"},
    {"id":"9383","name":"EU/3/15/1568: Public summary of opinion on orphan designation:\n\nInterferon alfa-n3 for the treatment of Middle East respiratory syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-05T01:00:00Z","last_updated_date":"2016-01-05T01:00:00Z","reference_number":"EMA/COMP/698747/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151568-public-summary-opinion-orphan-designation-interferon-alfa-n3-treatment-middle-east-respiratory-syndrome_en.pdf"},
    {"id":"9384","name":"Furazolidone: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-01-01T01:00:00Z","last_updated_date":"1997-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/furazolidone-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9386","name":"Presentation - Issues to address for a Tier B development plan (Barry Eisenstein)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-issues-address-tier-b-development-plan-barry-eisenstein_en.pdf"},
    {"id":"9388","name":"What's new in pharmacovigilance - QPPV Update - Issue 3","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2016-12-22T12:30:00Z","last_updated_date":"2016-12-22T12:30:00Z","reference_number":"Issue 3","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-3_en.pdf"},
    {"id":"9390","name":"Concept paper on revision of core SPC for human plasma fibrinogen products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-12-15T01:00:00Z","last_updated_date":"2005-12-15T01:00:00Z","reference_number":"EMEA/CHMP/BPWP/371017/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-core-spc-human-plasma-fibrinogen-products_en.pdf"},
    {"id":"9392","name":"Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - Children (Anne Brochot)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-importance-d-e-r-characterisation-dose-selection-labelling-and-br-children-anne-brochot_en.pdf"},
    {"id":"9394","name":"EU/3/12/1036 : Public summary of opinion on orphan designation:Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt for the treatment of familial chylomicronaem...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-05T01:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/COMP/527251/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121036-public-summary-opinion-orphan-designationtrans-4-4-5-6-trifluoromethyl-3-pyridinylamino-2-pyridinylphenyl-cyclohexane-acetic-acid-sodium-salt-treatment-familial-chylomicronaem_en.pdf"},
    {"id":"9396","name":"EU/3/01/079: Public summary of positive opinion for orphan designation of sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid for the treatment of acute lung injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMEA/COMP/48/02 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301079-public-summary-positive-opinion-orphan-designation-sinapultide-dipalmitoylphosphatidylcholine-palmitoyl-oleoyl-phosphatidylglycerol-and-palmitic-acid-treatment-acute-lung-injury_en.pdf"},
    {"id":"9397","name":"EU/3/10/755: Public summary of opinion on orphan designation: Octenidine dihydrochloride for the prevention of late-onset sepsis in premature infants of less than or equal to 32 weeks of gestational age","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-05T02:00:00Z","last_updated_date":"2010-08-05T02:00:00Z","reference_number":"EMA/COMP/264905/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310755-public-summary-opinion-orphan-designation-octenidine-dihydrochloride-prevention-late-onset-sepsis-premature-infants-less-or-equal-32-weeks-gestational-age_en.pdf"},
    {"id":"9399","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T16:30:00Z","last_updated_date":"2017-10-23T16:30:00Z","reference_number":"EMA/534841/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-autologous-keratinocytes_en.pdf"},
    {"id":"9401","name":"EU/3/16/1676: Public summary of opinion on orphan designation: Cyclocreatine for the treatment of creatine deficiency syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2019-07-09T12:00:00Z","reference_number":"EMA/396044/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161676-public-summary-opinion-orphan-designation-cyclocreatine-treatment-creatine-deficiency-syndromes_en.pdf"},
    {"id":"9402","name":"EU/3/05/336: Public summary of positive opinion for orphan designation of brostallicin for the treatment of soft-tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2013-07-08T02:00:00Z","reference_number":"EMEA/COMP/383867/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305336-public-summary-positive-opinion-orphan-designation-brostallicin-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"9404","name":"List of Participants - Training session for patients and consumers involved in EMA activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-21T01:00:00Z","last_updated_date":"2015-01-21T01:00:00Z","reference_number":"EMA/702994/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-training-session-patients-and-consumers-involved-ema-activities_en.pdf"},
    {"id":"9405","name":"Presentation - Module 2 - Engagement with stakeholders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-26T02:00:00Z","last_updated_date":"2018-03-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-2-engagement-stakeholders_en.pdf"},
    {"id":"9408","name":"European Medicines Agency-Food and Drug Administration good-clinical-practice initiative: Terms of engagement and procedures for participating authorities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-29T02:09:21Z","last_updated_date":"2009-07-29T02:09:21Z","reference_number":"EMEA/INS/GCP/538414/2008","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-food-and-drug-administration-good-clinical-practice-initiative-terms-engagement-and-procedures-participating-authorities_en.pdf"},
    {"id":"9410","name":"Ambroxol and bromhexine expectorants: safety information to be updated - Risk of allergy and skin reactions to be included in the product information","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/130676/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ambroxol-and-bromhexine-expectorants-safety-information-be-updated-risk-allergy-and-skin-reactions-be-included-product-information_en.pdf"},
    {"id":"9412","name":"EU/3/16/1818: Public summary of opinion on orphan designation: Human hepatoma cell line HepaRG in bioartificial liver for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/3424/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161818-public-summary-opinion-orphan-designation-human-hepatoma-cell-line-heparg-bioartificial-liver-treatment-acute-liver-failure_en.pdf"},
    {"id":"9413","name":"Flutiform - Article 29 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T02:00:00Z","last_updated_date":"2012-10-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flutiform-article-29-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flutiform-article-29-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flutiform-article-29-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flutiform-article-29-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flutiform-article-29-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flutiform-article-29-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flutiform-article-29-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flutiform-article-29-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flutiform-article-29-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flutiform-article-29-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flutiform-article-29-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flutiform-article-29-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flutiform-article-29-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flutiform-article-29-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flutiform-article-29-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flutiform-article-29-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flutiform-article-29-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flutiform-article-29-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flutiform-article-29-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flutiform-article-29-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flutiform-article-29-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flutiform-article-29-referral-annex-iii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/flutiform-article-29-referral-annex-iii_no.pdf"}},
    {"id":"9414","name":"Procedural advice to CHMP members","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-08-06T02:00:00Z","last_updated_date":"2008-08-06T02:00:00Z","reference_number":"EMEA/361945/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-chmp-members_en.pdf"},
    {"id":"9415","name":"Combined hormonal contraceptives Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"9417","name":"Presentation - Organ-on-chip networking in Europe (J. van den Eijnden-van Raaij)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T11:22:00Z","last_updated_date":"2017-11-15T11:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-organ-chip-networking-europe-j-van-den-eijnden-van-raaij_en.pdf"},
    {"id":"9419","name":"First medicine recommended for approval for hidradenitis suppurativa","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/CHMP/424261/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-medicine-recommended-approval-hidradenitis-suppurativa_en.pdf"},
    {"id":"9420","name":"Anthroposophic Medicine a key prescriber of Homeopathic Medicinal Products - Frank Mulder","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/anthroposophic-medicine-key-prescriber-homeopathic-medicinal-products-frank-mulder_en.pdf"},
    {"id":"9422","name":"Overview of comments received on the draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-16T16:10:00Z","last_updated_date":"2014-01-16T16:10:00Z","reference_number":"EMA/CHMP/748246/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders_en.pdf"},
    {"id":"9423","name":"ICH: E 8: General considerations for clinical trials - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-03-01T01:00:00Z","last_updated_date":"2022-12-02T14:15:00Z","reference_number":"EMA/CHMP/ICH/544570/1998 Corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-8-general-considerations-clinical-trials-step-5_en.pdf"},
    {"id":"9424","name":"Presentation - 2018 European Medicines Agency (EMA) and industry stakeholder interactions on Brexit related topics (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T02:00:00Z","last_updated_date":"2018-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2018-european-medicines-agency-ema-and-industry-stakeholder-interactions-brexit-related-topics-marie-helene-pinheiro_en.pdf"},
    {"id":"9426","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cresemba (isavuconazole) for the treatment of mucormycosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-11-05T15:52:00Z","last_updated_date":"2015-11-05T15:52:00Z","reference_number":"EMA/582963/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-cresemba-isavuconazole-treatment-mucormycosis_en.pdf"},
    {"id":"9427","name":"EU/3/10/781: Public summary of opinion on orphan designation: Glutathione-pegylated liposomal doxorubicin hydrochloride for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2015-05-08T02:00:00Z","reference_number":"EMA/COMP/360648/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310781-public-summary-opinion-orphan-designation-glutathione-pegylated-liposomal-doxorubicin-hydrochloride-treatment-glioma_en.pdf"},
    {"id":"9428","name":"Report on budgetary and financial management: Financial year 2013","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-07-01T12:15:00Z","last_updated_date":"2014-07-01T12:15:00Z","reference_number":"EMA/14575/2014","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2013_en.pdf"},
    {"id":"9429","name":"Minutes - Meeting with Alliance for Regenerative Medicine","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-02-06T13:00:00Z","last_updated_date":"2018-02-06T13:00:00Z","reference_number":"EMA/37264/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-meeting-alliance-regenerative-medicine_en.pdf"},
    {"id":"9430","name":"Sixth meeting of the Management Board of the European Agency for the Evaluation of Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1995-04-24T02:00:00Z","last_updated_date":"1995-04-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/sixth-meeting-management-board-european-agency-evaluation-medicinal-products_en.pdf"},
    {"id":"9431","name":"Work instructions for handling of paediatric Article 46 work-sharing procedures by the Co-ordination Group for Mutual Recognition and Decentralised Procedure – Human (CMDh) secretariat","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"WIN/H/3376","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-handling-paediatric-article-46-work-sharing-procedures-co-ordination-group-mutual-recognition-and-decentralised-procedure-human-cmdh-secretariat_en.pdf"},
    {"id":"9432","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 14-17 December 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-01-05T13:30:00Z","last_updated_date":"2016-01-05T13:30:00Z","reference_number":"EMA/38808/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-14-17-december-2015_en.pdf"},
    {"id":"9434","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Procysbi (mercaptamine) for the treatment of cystinosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2013-10-10T02:00:00Z","last_updated_date":"2013-10-10T02:00:00Z","reference_number":"EMA/COMP/415414/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-procysbi-mercaptamine-treatment-cystinosis_en.pdf"},
    {"id":"9435","name":"Presentation - The role of the European Network of Paediatric Research at the European Medicines Agency - A neonatal network‘s perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:54Z","last_updated_date":"2011-05-27T15:25:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-european-network-paediatric-research-european-medicines-agency-neonatal-networks-perspective_en.pdf"},
    {"id":"9436","name":"EU/3/06/393: Public summary of positive opinion for orphan designation\n\nof autologous CD34+ cells transfected with retroviral vector containing the human gp91 (phox) gene for the treatment of chronic granulomatous diseas...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/278975/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306393-public-summary-positive-opinion-orphan-designation-autologous-cd34-cells-transfected-retroviral-vector-containing-human-gp91-phox-gene-treatment-chronic-granulomatous-diseas_en.pdf"},
    {"id":"9437","name":"EMA starts new review of hydroxyethyl-starch containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T14:00:00Z","last_updated_date":"2017-10-27T14:00:00Z","reference_number":"EMA/697706/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-starts-new-review-hydroxyethyl-starch-containing-medicines_en.pdf"},
    {"id":"9438","name":"Anise oil: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-10-06T02:00:00Z","last_updated_date":"2016-10-06T02:00:00Z","reference_number":"EMA/412178/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/anise-oil-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/anise-oil-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/anise-oil-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/anise-oil-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/anise-oil-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/anise-oil-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/anise-oil-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/anise-oil-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/anise-oil-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/anise-oil-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/anise-oil-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/anise-oil-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/anise-oil-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/anise-oil-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/anise-oil-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/anise-oil-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/anise-oil-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/anise-oil-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/anise-oil-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/anise-oil-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/anise-oil-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/anise-oil-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/anise-oil-summary-public_sv.pdf"}},
    {"id":"9440","name":"European Medicines Agency recommends approval of first two monoclonal antibody biosimilars","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/390722/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-first-two-monoclonal-antibody-biosimilars_en.pdf"},
    {"id":"9441","name":"Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-04-21T02:00:00Z","last_updated_date":"2008-04-21T02:00:00Z","reference_number":"EMEA/CVMP/SWP/173804/2008-CONS","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-user-safety-pharmaceutical-veterinary-medicinal-products_en.pdf"},
    {"id":"9443","name":"Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (27 June 2017)","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-06-06T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"EMA/213892/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-27-june-2017_en.pdf"},
    {"id":"9445","name":"Post-Authorisation Procedural Advice: Human Medicinal Products: New Variation Regulation (EC) No 1234/2008","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-01-20T00:09:21Z","last_updated_date":"2010-01-20T00:09:21Z","reference_number":"EMA/40404/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/post-authorisation-procedural-advice-human-medicinal-products-new-variation-regulation-ec-no-12342008_en.pdf"},
    {"id":"9446","name":"Initial notices for parallel distribution – May 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-06-16T18:58:00Z","last_updated_date":"2014-06-16T18:58:00Z","reference_number":"EMA/342868/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-may-2014_en.pdf"},
    {"id":"9447","name":"20th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-01-28T00:09:21Z","last_updated_date":"2002-01-28T00:09:21Z","reference_number":"EMEA/COMP/38/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/20th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"9449","name":"Presentation - Update on patient involvement in evaluation activities (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-patient-involvement-evaluation-activities-isabelle-moulon_en.pdf"},
    {"id":"9454","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 23-26 April 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2018-04-26T14:00:00Z","last_updated_date":"2018-04-26T14:00:00Z","reference_number":"EMA/CHMP/SAWP/262775/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-23-26-april-2018_en.pdf"},
    {"id":"9458","name":"Novo Nordisk withdraw their application to extend the marketing authorisation for NovoSeven","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-04-06T02:00:00Z","last_updated_date":"2006-04-06T02:00:00Z","reference_number":"EMEA/123938/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/novo-nordisk-withdraw-their-application-extend-marketing-authorisation-novoseven_en.pdf"},
    {"id":"9459","name":"Presentation - PRAC's perspective: Regulatory challenges and opportunities - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines (Jun...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pracs-perspective-regulatory-challenges-and-opportunities-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"9460","name":"Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T14:00:00Z","last_updated_date":"2016-04-22T14:00:00Z","reference_number":"EMA/CHMP/292464/2014","document_url":"https://www.ema.europa.eu/en/documents/other/appendix-2-guideline-evaluation-anticancer-medicinal-products-man_en.pdf"},
    {"id":"9461","name":"Presentation - Update on the implementation of the pharmacovigilance legislation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-implementation-pharmacovigilance-legislation_en.pdf"},
    {"id":"9464","name":"25th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-07-01T02:09:21Z","last_updated_date":"2002-07-01T02:09:21Z","reference_number":"EMEA/15523/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/25th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"9469","name":"Background information - Symposium: Raw materials for production of cell-based and gene-therapy products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T15:00:00Z","last_updated_date":"2013-01-28T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/background-information-symposium-raw-materials-production-cell-based-and-gene-therapy-products_en.pdf"},
    {"id":"9472","name":"Aprotinin: List of nationally authorised medicinal products - PSUSA/00000230/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T16:38:00Z","last_updated_date":"2016-11-04T16:39:56Z","reference_number":"EMA/728577/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/aprotinin-list-nationally-authorised-medicinal-products-psusa00000230201602_en.pdf"},
    {"id":"9475","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-09-08T02:00:00Z","last_updated_date":"2011-09-08T02:00:00Z","reference_number":"EMA/544716/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting_en.pdf-0"},
    {"id":"9476","name":"Agenda - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-03-07T10:13:00Z","last_updated_date":"2017-05-17T12:30:00Z","reference_number":"EMA/762357/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"9477","name":"Triclabendazole: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/triclabendazole-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9478","name":"Final European Union herbal monograph on Equisetum arvense L., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-03-17T01:00:00Z","reference_number":"EMA/HMPC/278091/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-equisetum-arvense-l-herba_en.pdf"},
    {"id":"9483","name":"Moxidectin (Modification of the ADI and extension to bovine milk): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-02-01T01:00:00Z","last_updated_date":"2001-02-01T01:00:00Z","reference_number":"EMEA/MRL/777/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/moxidectin-modification-adi-and-extension-bovine-milk-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9488","name":"Increasing access to reports on adverse reactions to medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/846880/2015 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/increasing-access-reports-adverse-reactions-medicines_en.pdf"},
    {"id":"9489","name":"Final assessment report on Cichorium intybus L., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-14T16:00:00Z","last_updated_date":"2013-03-14T16:00:00Z","reference_number":"EMA/HMPC/113041/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-cichorium-intybus-l-radix_en.pdf"},
    {"id":"9490","name":"Bicalutamide - Article 31 referral - Annex I, II, III, IV","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-10-03T02:08:21Z","last_updated_date":"2007-10-03T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bicalutamide-article-31-referral-annex-i-ii-iii-iv_sv.pdf"}},
    {"id":"9492","name":"Questions and answers on the withdrawal of the marketing application for  Multaq","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-09-21T02:00:00Z","last_updated_date":"2006-09-21T02:00:00Z","reference_number":"EMEA/389502/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-multaq_sv.pdf"}},
    {"id":"9493","name":"EU/3/16/1727 : Public summary of opinion on orphan designation: Recombinant human interleukin-12 for treatment of acute radiation syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161727-public-summary-opinion-orphan-designation-recombinant-human-interleukin-12-treatment-acute-radiation-syndrome_en.pdf"},
    {"id":"9494","name":"Overview of comments received on ‘guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations’ - Revision 1","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-09T16:10:00Z","last_updated_date":"2012-02-09T16:10:00Z","reference_number":"EMA/CHMP/CVMP/QWP/989848/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-use-near-infrared-spectroscopy-pharmaceutical-industry-and-data-requirements-new-submissions-and-variations-revision-1_en.pdf"},
    {"id":"9495","name":"Note for guidance on non-clinical local tolerance testing of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-03-01T01:00:00Z","last_updated_date":"2001-03-01T01:00:00Z","reference_number":"CPMP/SWP/2145/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-non-clinical-local-tolerance-testing-medicinal-products_en.pdf"},
    {"id":"9496","name":"CHMP statistics: September 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-september-2017_en.pdf"},
    {"id":"9497","name":"EU/3/13/1226: Public summary of opinion on orphan designation: (6aS)-1,10-dimethoxy-6-methyl-5,6,6a,7-tetrahydro-4H-dibenzo[de,g]quinoline-2,9-diol for the treatment of dystrophic myotonia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/COMP/18322/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131226-public-summary-opinion-orphan-designation-6as-110-dimethoxy-6-methyl-566a7-tetrahydro-4h-dibenzodegquinoline-29-diol-treatment-dystrophic-myotonia_en.pdf"},
    {"id":"9502","name":"Consolidated final report on the activities of patients’ and consumers’ working party and healthcare professionals’ working party  topic groups (2015)","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2017-05-30T11:56:00Z","last_updated_date":"2017-05-30T11:56:00Z","reference_number":"EMA/225307/2017","document_url":"https://www.ema.europa.eu/en/documents/annual-report/consolidated-final-report-activities-patients-and-consumers-working-party-and-healthcare-professionals-working-party-topic-groups-2015_en.pdf"},
    {"id":"9503","name":"Committee for medicinal products for veterinary use -\n\nEMEA public bulletin 2004 on veterinary pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-01-12T01:00:00Z","last_updated_date":"2005-01-12T01:00:00Z","reference_number":"EMEA/CVMP/066/05-FINAL","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-emea-public-bulletin-2004-veterinary-pharmacovigilance_en.pdf"},
    {"id":"9505","name":"Presentation - Case study: Sample size estimation for a paediatric clinical trial utilising external information from historical trials in adults and children - Break-out session 3 theme 4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-sample-size-estimation-paediatric-clinical-trial-utilising-external-information-historical-trials-adults-and-children-break-out-session-3-theme-4_en.pdf"},
    {"id":"9508","name":"Baquiloprim: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-02-01T01:00:00Z","last_updated_date":"1996-02-01T01:00:00Z","reference_number":"EMEA/MRL/048/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/baquiloprim-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9509","name":"Presentation - Industry challenges for developing emergency vaccines (David John)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T11:37:00Z","last_updated_date":"2017-05-18T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-challenges-developing-emergency-vaccines-david-john_en.pdf"},
    {"id":"9510","name":"EU initiatives for research on rare diseases: Charles Kessler","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-initiatives-research-rare-diseases-charles-kessler_en.pdf"},
    {"id":"9513","name":"Reflection paper on the use of pharmacogenetics in the pharmacokinetic evaluation of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-05-25T02:00:00Z","last_updated_date":"2007-05-25T02:00:00Z","reference_number":"EMEA/128517/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-pharmacogenetics-pharmacokinetic-evaluation-medicinal-products_en.pdf"},
    {"id":"9514","name":"CHMP post-authorisation summary of positive opinion for Imbruvica","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/493040/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imbruvica_en.pdf"},
    {"id":"9515","name":"Pergolide: List of nationally authorised medicinal products -  PSUSA/00002351/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-07T13:30:00Z","last_updated_date":"2017-09-07T13:30:06Z","reference_number":"EMA/592458/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/pergolide-list-nationally-authorised-medicinal-products-psusa00002351201612_en.pdf"},
    {"id":"9517","name":"Presentation - Identification and traceability of biological products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-identification-and-traceability-biological-products_en.pdf"},
    {"id":"9519","name":"Overview of GMP Inspections conducted by Irish Medicines Board - Lorraine Nolan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-gmp-inspections-conducted-irish-medicines-board-lorraine-nolan_en.pdf"},
    {"id":"9522","name":"Questions and answers on Seroquel XR and associated names (50, 150, 200, 300 and 400 mg prolonged-release tablets containing quetiapine)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-seroquel-xr-and-associated-names-50-150-200-300-and-400-mg-prolonged-release-tablets-containing-quetiapine_sv.pdf"}},
    {"id":"9524","name":"EU/3/05/316: Public summary of positive opinion for orphan designation\n\nof 2-{4-[(5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl)acetamide for the treatment of pulmonary arterial hypertension and chr...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMEA/COMP/247593/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305316-public-summary-positive-opinion-orphan-designation-2-4-56-diphenylpyrazin-2-ylisopropylaminobutoxy-n-methylsulfonylacetamide-treatment-pulmonary-arterial-hypertension-and-chr_en.pdf"},
    {"id":"9525","name":"Presentation - Identifying centres and networks with the capacity and expertise to conduct PASS in children (Dirk Mentzer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-identifying-centres-and-networks-capacity-and-expertise-conduct-pass-children-dirk-mentzer_en.pdf"},
    {"id":"9528","name":"European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - Terms of reference and procedures for participating authorities (manufacturers of medicinal products...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-11-15T01:00:00Z","last_updated_date":"2010-11-15T01:00:00Z","reference_number":"EMA/660316/2010","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-food-and-drug-administration-joint-good-manufacturing-practice-inspection-pilot-programme-terms-reference-and-procedures-participating-authorities-manufacturers-medicinal_en.pdf"},
    {"id":"9529","name":"CHMP summary of positive opinion for Imatinib Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2012-10-19T14:30:00Z","reference_number":"EMA/CHMP/597641/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imatinib-teva_en.pdf"},
    {"id":"9530","name":"EU/3/06/388: Public summary of positive opinion for orphan designationof becatecarin for the treatment of cancers of the biliary tree","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/226408/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306388-public-summary-positive-opinion-orphan-designationof-becatecarin-treatment-cancers-biliary-tree_en.pdf"},
    {"id":"9532","name":"Paediatric rheumatology expert group meeting - Conclusions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2011-02-16T01:00:00Z","reference_number":"EMA/89878/2010","document_url":"https://www.ema.europa.eu/en/documents/other/paediatric-rheumatology-expert-group-meeting-conclusions_en.pdf"},
    {"id":"9534","name":"Protelos / Osseor: Product information as approved by the CHMP on 15 March 2012, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T11:00:00Z","last_updated_date":"2012-03-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/protelos-osseor-product-information-approved-chmp-15-march-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"9535","name":"Clorsulon (cattle): European Public MRL Assessment Report (EPMAR) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2008-08-04T02:00:00Z","last_updated_date":"2008-08-04T02:00:00Z","reference_number":"EMEA/CVMP/358525/2008","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/clorsulon-cattle-european-public-mrl-assessment-report-epmar-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9537","name":"Opinion of the CVMP on the establishment of maximum residue limits: Prednisolone","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-07-30T19:45:00Z","last_updated_date":"2013-07-30T19:45:00Z","reference_number":"EMA/CVMP/382060/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-prednisolone_en.pdf"},
    {"id":"9542","name":"Use of antiretroviral treatment in HIV-patients with hepatic impairment\n\nand/or HBV/HCV co-infection","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-08-06T01:31:00Z","last_updated_date":"2005-08-06T01:31:00Z","reference_number":"EMEA/CHMP/249537/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/use-antiretroviral-treatment-hiv-patients-hepatic-impairment-andor-hbvhcv-co-infection_en.pdf"},
    {"id":"9543","name":"European Medicines Agency decision CW-0001-2015 of 23 July 2015 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-23T13:00:00Z","last_updated_date":"2018-05-28T17:30:00Z","reference_number":"EMA/498952/2015","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-decision-cw-0001-2015-23-july-2015-class-waivers-accordance-regulation-ec-no-1901-2006-european-parliament-and-council_en.pdf"},
    {"id":"9544","name":"Presentation - Identification of medicinal products (IDMP) actions log on Substance, Product, Organisation and Referential (SPOR)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-identification-medicinal-products-idmp-actions-log-substance-product-organisation-and-referential-spor_en.pdf"},
    {"id":"9546","name":"Presentation - Support available to SMEs nationally and internationally – Afssaps, Dr. Stephane Palies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-support-available-smes-nationally-and-internationally-afssaps-dr-stephane-palies_en.pdf"},
    {"id":"9547","name":"Committee for veterinary medicinal products: 48th meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1999-10-14T14:39:21Z","last_updated_date":"1999-10-14T14:39:21Z","reference_number":"EMEA/CVMP/726/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-48th-meeting_en.pdf"},
    {"id":"9548","name":"Methotrexate Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2018-04-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methotrexate-article-31-referral-notification_en.pdf"},
    {"id":"9549","name":"Retinoid Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-notification_en.pdf"},
    {"id":"9550","name":"Programme - European Medicines Agency/International Federation for Animal Health-Europe info day 2015","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T17:00:00Z","last_updated_date":"2015-03-10T11:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-european-medicines-agencyinternational-federation-animal-health-europe-info-day-2015_en.pdf"},
    {"id":"9552","name":"Summary - Selection and handling of the test manure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:09:21Z","last_updated_date":"2009-06-23T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/summary-selection-and-handling-test-manure_en.pdf"},
    {"id":"9553","name":"CHMP post-authorisation summary of positive opinion for Thyrogen","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/CHMP/745393/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-thyrogen_en.pdf"},
    {"id":"9554","name":"Presentation - Workshop on patient’s voice in the evaluation of medicines - Patient involvement in the PRAC (Jane Ahlqvist Rastad)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T01:00:00Z","last_updated_date":"2013-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patients-voice-evaluation-medicines-patient-involvement-prac-jane-ahlqvist-rastad_en.pdf"},
    {"id":"9555","name":"Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-06-26T16:00:00Z","last_updated_date":"2018-06-26T16:00:00Z","reference_number":"EMA/CHMP/356876/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ibuprofen-oral-use-immediate-release-formulations-200-800-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"9556","name":"3.1 Annex I - Statistical analysis methods compatible with EMA bioequivalence guideline","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-09T16:00:00Z","last_updated_date":"2016-11-09T16:00:00Z","reference_number":"EMA/582648/2016","document_url":"https://www.ema.europa.eu/en/documents/other/31-annex-i-statistical-analysis-methods-compatible-ema-bioequivalence-guideline_en.pdf"},
    {"id":"9559","name":"Update on the implementation of the EU Telematics strategy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-10-01T02:09:21Z","last_updated_date":"2009-10-01T02:09:21Z","reference_number":"EMEA/528743/2009","document_url":"https://www.ema.europa.eu/en/documents/report/update-implementation-eu-telematics-strategy_en.pdf-0"},
    {"id":"9560","name":"Improving the perception and use of the Article 58 procedure- An action plan for 2015-2017","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/756676/2015-Rev 1","document_url":"https://www.ema.europa.eu/en/documents/other/improving-perception-and-use-article-58-procedure-action-plan-2015-2017_en.pdf"},
    {"id":"9561","name":"Agenda - PRAC draft agenda of meeting 2-5 December 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-12-02T18:20:00Z","last_updated_date":"2013-12-02T18:20:00Z","reference_number":"EMA/PRAC/748572/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-2-5-december-2013_en.pdf"},
    {"id":"9562","name":"Dexibuprofen: List of nationally authorised medicinal products - PSUSA/00000996/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-22T15:33:00Z","last_updated_date":"2018-05-22T15:37:31Z","reference_number":"EMA/302974/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexibuprofen-list-nationally-authorised-medicinal-products-psusa00000996201708_en.pdf"},
    {"id":"9563","name":"Draft list of references supporting the assessment of Eucalyptus globulus Labill., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2012-06-21T16:01:00Z","last_updated_date":"2012-06-21T16:01:00Z","reference_number":"EMA/HMPC/892623/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-eucalyptus-globulus-labill-folium_en.pdf"},
    {"id":"9564","name":"Presentation - Pharmacokinetics and pharmacogenomics: Building blocks for the cases in session 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacokinetics-and-pharmacogenomics-building-blocks-cases-session-3_en.pdf"},
    {"id":"9565","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation for Vpriv (velaglucerase alfa) for the treatment of Gaucher disease","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2010-09-13T02:00:00Z","last_updated_date":"2022-09-09T02:00:00Z","reference_number":"EMA/COMP/433831/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-vpriv-velaglucerase-alfa-treatment-gaucher-disease_en.pdf"},
    {"id":"9566","name":"List of participants - Developing a framework of collaboration between EMA and academia","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T13:00:00Z","last_updated_date":"2016-07-11T13:00:00Z","reference_number":"EMA/362719/2016","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-developing-framework-collaboration-between-ema-and-academia_en.pdf"},
    {"id":"9568","name":"Public hearing on quinolone and fluoroquinolone - Written interventions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-06-20T12:30:00Z","last_updated_date":"2018-06-25T14:21:00Z","reference_number":"EMA/225564/2018 Corr. *","document_url":"https://www.ema.europa.eu/en/documents/other/public-hearing-quinolone-and-fluoroquinolone-written-interventions_en.pdf"},
    {"id":"9570","name":"ICH guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T12:00:00Z","reference_number":"CPMP/ICH/286/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m3r2-non-clinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorisation-pharmaceuticals-step-5_en.pdf"},
    {"id":"9572","name":"Scientific recommendation on classification of advanced therapy medicinal products: Hepatocyte-like cells are cryopreserved in the freezing solution, solution for injection","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T12:45:00Z","last_updated_date":"2016-04-12T12:45:00Z","reference_number":"EMA/213701/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-hepatocyte-cells-are-cryopreserved-freezing-solution-solution-injection_en.pdf"},
    {"id":"9573","name":"PRAC recommends restricting use of domperidone","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"EMA/129231/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-restricting-use-domperidone_en.pdf"},
    {"id":"9577","name":"CVMP summary of positive opinion for BTVPUR AlSap 2-4","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-07-16T02:00:00Z","last_updated_date":"2018-11-13T02:00:00Z","reference_number":"EMA/CVMP/256124/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-btvpur-alsap-2-4_en.pdf"},
    {"id":"9579","name":"Investigation into GLP-1-based diabetes therapies concluded","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/463027/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/investigation-glp-1-based-diabetes-therapies-concluded_en.pdf"},
    {"id":"9582","name":"Summary information on a referral opinion following an arbitration pursuant to Article 29 of Directive 2001/83/EC (formerly Article 10, paragraph 2 of Directive 75/319/EEC of 20 May 1975 as amended) for Dacarbazine Fauld...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-09-19T02:08:21Z","last_updated_date":"2002-09-19T02:08:21Z","reference_number":"CPMP/2020/02","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-29-directive-200183ec-formerly-article-10-paragraph-2-directive-75319eec-20-may-1975-amended-dacarbazine-fauld_en.pdf"},
    {"id":"9585","name":"Presentation - Scientific developments: VICH update on work on biological (Esther Werner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-developments-vich-update-work-biological-esther-werner_en.pdf"},
    {"id":"9586","name":"Presentation - Update on investigational ATMP concept paper guideline (Ilona Reischl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-investigational-atmp-concept-paper-guideline-ilona-reischl_en.pdf"},
    {"id":"9587","name":"Summary of transfer of appropriations in the budget 2011 - Management Board meeting: 15 December 2011","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T11:30:00Z","last_updated_date":"2011-12-20T11:30:00Z","reference_number":"EMA/MB/902314/2011","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2011-management-board-meeting-15-december-2011_en.pdf"},
    {"id":"9588","name":"Cyromazine: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-06-01T02:00:00Z","last_updated_date":"1999-06-01T02:00:00Z","reference_number":"EMEA/MRL/606/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cyromazine-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9589","name":"News bulletin for small and medium-sized enterprises - Issue 1","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2007-05-01T02:00:00Z","last_updated_date":"2007-05-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-1_en.pdf"},
    {"id":"9590","name":"Presentation - Regulatory view (Flora Musuamba Tshinanu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-view-flora-musuamba-tshinanu_en.pdf"},
    {"id":"9591","name":"Draft assessment report on Primula veris L. and / or Primula elatior (L.) Hill, flos","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMEA/HMPC/64683/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-primula-veris-l-and-or-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"9594","name":"Draft 2 guideline on the quality of biological active substances produced by stable transgene expression in higher plants","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-07-19T02:00:00Z","last_updated_date":"2006-07-19T02:00:00Z","reference_number":"EMEA/CHMP/BWP/48316/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-2-guideline-quality-biological-active-substances-produced-stable-transgene-expression-higher-plants_en.pdf"},
    {"id":"9595","name":"EMEA meeting with interested parties and research centres on ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) - Summary of the Outcome of the Working Groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-12-17T01:00:00Z","last_updated_date":"2007-12-17T01:00:00Z","reference_number":"EMEA/601105/2007","document_url":"https://www.ema.europa.eu/en/documents/other/emea-meeting-interested-parties-and-research-centres-encepp-european-network-centres-pharmacoepidemiology-and-pharmacovigilance-summary-outcome-working-groups_en.pdf"},
    {"id":"9596","name":"PRAC meeting dates 2012, 2013, 2014 and 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2014-06-03T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/prac-meeting-dates-2012-2013-2014-and-2015_en.pdf"},
    {"id":"9597","name":"Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T16:00:00Z","last_updated_date":"2016-12-07T16:00:00Z","reference_number":"EMA/819150/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-iv-formulation-list-nationally-authorised-medicinal-products-psusa00002311201605_en.pdf"},
    {"id":"9599","name":"News bulletin for small and medium-sized enterprises - Issue 16","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2011-06-30T02:00:00Z","last_updated_date":"2011-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-16_en.pdf"},
    {"id":"9605","name":"Kytril - Article 30 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-09-12T02:00:00Z","last_updated_date":"2011-09-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kytril-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kytril-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kytril-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kytril-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kytril-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kytril-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kytril-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kytril-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kytril-article-30-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kytril-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kytril-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kytril-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kytril-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kytril-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kytril-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kytril-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kytril-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kytril-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kytril-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kytril-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kytril-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kytril-article-30-referral-annex-i_sv.pdf"}},
    {"id":"9606","name":"Superseded annex to note for guidance on development pharmaceutics: Decision trees for the selection of sterilisation methods","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-04-05T02:00:00Z","last_updated_date":"2000-04-05T02:00:00Z","reference_number":"CPMP/QWP/054/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/superseded-annex-note-guidance-development-pharmaceutics-decision-trees-selection-sterilisation-methods_en.pdf"},
    {"id":"9609","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of individual case safety report (ICSRs) in the ISO/ICH E2B(R3) format: hands-on training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-03-20T15:57:00Z","last_updated_date":"2017-06-15T16:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-individual-case-safety-report-icsrs-isoich-e2br3-format-hands-training-course_en.pdf"},
    {"id":"9610","name":"Minutes of the European Union International Organisation for Standardization (ISO) identification of medicinal products (IDMP) task force meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-03-15T15:00:00Z","last_updated_date":"2016-03-15T15:00:00Z","reference_number":"EMA/155769/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-international-organisation-standardization-iso-identification-medicinal-products-idmp-task-force-meeting_en.pdf"},
    {"id":"9611","name":"Overview of the European Medicines Agency’s role, activities and priorities for 2015","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2015-05-18T18:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/overview-european-medicines-agencys-role-activities-and-priorities-2015_en.pdf"},
    {"id":"9613","name":"Withdrawal assessment report for Exulett","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-01-05T01:00:00Z","last_updated_date":"2009-01-05T01:00:00Z","reference_number":"EMEA/CHMP/655741/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-exulett_en.pdf"},
    {"id":"9614","name":"Questions and answers on refusal of the marketing authorisation for Nerventra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-05-23T14:00:00Z","reference_number":"EMA/311892/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-nerventra_sv.pdf"}},
    {"id":"9616","name":"Opinion of the HMPC on a European Union herbal monograph on Valeriana officinalis L., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:30:00Z","last_updated_date":"2016-04-27T12:30:00Z","reference_number":"EMA/HMPC/74082/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"9618","name":"EU/3/03/163: Public summary of positive opinion for orphan designation of 5,6,7,8 tetrahydrobiopterin for the treatment of hyperphenylalaninemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-23T00:00:00Z","last_updated_date":"2007-02-23T00:00:00Z","reference_number":"EMEA/COMP/1387/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303163-public-summary-positive-opinion-orphan-designation-5678-tetrahydrobiopterin-treatment-hyperphenylalaninemia_en.pdf"},
    {"id":"9621","name":"Withdrawal assessment report for Sutent","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-08-17T11:20:00Z","last_updated_date":"2018-08-17T11:20:00Z","reference_number":"EMA/CHMP/481973/2018","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-sutent_en.pdf"},
    {"id":"9624","name":"Letter from the European Commission and the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-commission-and-european-medicines-agency_en.pdf"},
    {"id":"9627","name":"CHMP summary of positive opinion for Entecavir Mylan","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T14:00:00Z","last_updated_date":"2017-07-21T14:00:00Z","reference_number":"EMA/CHMP/275743/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-entecavir-mylan_en.pdf"},
    {"id":"9628","name":"Draft list of references supporting the assessment of  Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"EMEA/HMPC/111736/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"9630","name":"Assessment of the paediatric needs - Psychiatry","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2007-07-27T02:00:00Z","last_updated_date":"2007-07-27T02:00:00Z","reference_number":"EMEA/288917/2007","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-psychiatry_en.pdf"},
    {"id":"9632","name":"Thiocolchicoside Article-31 referral - Divergent positions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-06T01:00:00Z","last_updated_date":"2014-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-divergent-positions_en.pdf"},
    {"id":"9633","name":"Presentation - Overview of recent changes in the centralised procedure (Michael Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T14:00:01Z","last_updated_date":"2015-11-12T14:00:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-recent-changes-centralised-procedure-michael-berntgen_en.pdf"},
    {"id":"9635","name":"CHMP post-authorisation summary of positive opinion for Protelos","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/313022/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-protelos_en.pdf"},
    {"id":"9636","name":"Assessment of the paediatric needs - Cardiovascular products","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-10-01T02:00:00Z","last_updated_date":"2006-10-01T02:00:00Z","reference_number":"EMEA/439649/2006","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-cardiovascular-products_en.pdf"},
    {"id":"9638","name":"Agenda - Workshop on biosimilars","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-11-12T13:00:00Z","reference_number":"EMA/473908/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-biosimilars_en.pdf"},
    {"id":"9640","name":"Registration form - European Medicines Agency veterinary medicines info day","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T12:00:00Z","last_updated_date":"2016-12-20T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-european-medicines-agency-veterinary-medicines-info-day_en.doc"},
    {"id":"9641","name":"European Medicines Agency finalises review of Baxter’s dialysis solutions","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/771913/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-finalises-review-baxters-dialysis-solutions_en.pdf"},
    {"id":"9642","name":"EU/3/04/230: Public summary of positive opinion for orphan designation of dexamethasone sodium phosphate encapsulated in human erythrocytes for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T01:00:00Z","last_updated_date":"2010-02-22T00:00:00Z","reference_number":"EMEA/COMP/77487/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304230-public-summary-positive-opinion-orphan-designation-dexamethasone-sodium-phosphate-encapsulated-human-erythrocytes-treatment-cystic-fibrosis_en.pdf"},
    {"id":"9643","name":"European Union recommendations for the seasonal-influenza-vaccine composition for the season 2010 / 2011","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-03-18T01:00:00Z","last_updated_date":"2010-03-18T01:00:00Z","reference_number":"EMA/CHMP/BWP/107653/2010","document_url":"https://www.ema.europa.eu/en/documents/report/european-union-recommendations-seasonal-influenza-vaccine-composition-season-2010-2011_en.pdf"},
    {"id":"9644","name":"Triclabendazole (all ruminants milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-18T02:00:00Z","last_updated_date":"2014-08-18T02:00:00Z","reference_number":"EMA/CVMP/649781/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/triclabendazole-all-ruminants-milk-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"9646","name":"Draft assessment report on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-04-19T02:00:00Z","last_updated_date":"2013-04-19T02:00:00Z","reference_number":"EMA/HMPC/283629/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"9650","name":"PRAC recommends restricting use of domperidone","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"EMA/129231/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-recommends-restricting-use-domperidone_en.pdf"},
    {"id":"9653","name":"Semler - Marketing authorisations which are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation as adopted by the CHMP on 21 July 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/499744/2016","document_url":"https://www.ema.europa.eu/en/documents/other/semler-marketing-authorisations-which-are-recommended-suspension-and-marketing-authorisation-applications-which-do-not-satisfy-criteria-authorisation-adopted-chmp-21-july-2016_en.pdf"},
    {"id":"9654","name":"Lasalocid sodium (Extension to eggs): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-07-01T02:00:00Z","last_updated_date":"2006-07-01T02:00:00Z","reference_number":"EMEA/CVMP/46049/2006-FINAL-corr","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lasalocid-sodium-extension-eggs-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9655","name":"CHMP post-authorisation summary of positive opinion for Viread","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2010-07-23T02:00:00Z","reference_number":"EMA/CHMP/473630/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-viread_en.pdf"},
    {"id":"9657","name":"Minutes - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting_en.pdf"},
    {"id":"9660","name":"European public health agencies evaluate antibiotic resistance of Staphylococcus aureus","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-16T02:00:00Z","last_updated_date":"2009-06-16T02:00:00Z","reference_number":"EMEA/374416/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-public-health-agencies-evaluate-antibiotic-resistance-staphylococcus-aureus_en.pdf"},
    {"id":"9662","name":"Reflection paper on management of clinical risks deriving from insertional mutagenesis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T16:20:00Z","last_updated_date":"2013-08-01T16:20:00Z","reference_number":"EMA/CAT/190186/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-management-clinical-risks-deriving-insertional-mutagenesis_en.pdf"},
    {"id":"9663","name":"Download EPS - Species pictograms - Goose","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-goose_en.zip"},
    {"id":"9664","name":"CVMP summary of positive opinion for Zeleris","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/CVMP/69359/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-zeleris_en.pdf"},
    {"id":"9665","name":"Loraxin - Article-29(4) referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-02-28T01:00:00Z","last_updated_date":"2013-02-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/loraxin-article-294-referral-annex-i-ii-iii_no.pdf"}},
    {"id":"9668","name":"Mock-ups checklist - Guidance for checking mock-ups","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-04-01T20:00:00Z","last_updated_date":"2022-02-02T17:20:00Z","reference_number":"EMA/102667/2014 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/mock-ups-checklist-guidance-checking-mock-ups_en.pdf"},
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    {"id":"9670","name":"EU/3/17/1859: Public summary of opinion on orphan designation: Phosphoinositide 3-kinase gamma peptide for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/143975/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171859-public-summary-opinion-orphan-designation-phosphoinositide-3-kinase-gamma-peptide-treatment-cystic-fibrosis_en.pdf"},
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    {"id":"9672","name":"Prokanazol - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-08-06T02:08:21Z","last_updated_date":"2009-08-06T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/prokanazol-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"9674","name":"EU/3/13/1222: Public summary of opinion on orphan designation: Amatuximab for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/COMP/7038/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131222-public-summary-opinion-orphan-designation-amatuximab-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"9675","name":"Draft list of references supporting the assessment of Paeonia lactiflora Pall. and Paeonia veitchii Lynch, radix (Paeoniae radix rubra)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-02-16T01:00:00Z","last_updated_date":"2016-02-16T01:00:00Z","reference_number":"EMA/HMPC/762955/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-paeonia-lactiflora-pall-and-paeonia-veitchii-lynch-radix-paeoniae-radix-rubra_en.pdf"},
    {"id":"9676","name":"Final list of references supporting the assessment of Peumus boldus Molina, folium","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2017-01-12T10:48:00Z","last_updated_date":"2017-01-12T10:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-peumus-boldus-molina-folium_en.pdf"},
    {"id":"9677","name":"EU/3/11/853: Public summary of positive opinion for orphan designation:  Ombrabulin for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2014-06-19T02:00:00Z","reference_number":"EMA/COMP/69581/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311853-public-summary-positive-opinion-orphan-designation-ombrabulin-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"9679","name":"CVMP post-authorisation summary of positive opinion for Suprelorin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-04-16T02:00:00Z","last_updated_date":"2010-04-16T02:00:00Z","reference_number":"EMA/CVMP/149474/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-suprelorin_en.pdf"},
    {"id":"9681","name":"Presentation - Early dialogue: Focus on PRIME (Rob Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-dialogue-focus-prime-rob-hemmings_en.pdf"},
    {"id":"9683","name":"CHMP post-authorisation summary of positive opinion for Avastin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/CHMP/295853/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-avastin_en.pdf-0"},
    {"id":"9684","name":"EU/3/03/162: Public summary of positive opinion for orphan designation of  yttrium (90Y) antiferritin polyclonal antibodies for the treatment of Hodgkin lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2013-06-20T13:00:00Z","reference_number":"EMEA/COMP/384/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303162-public-summary-positive-opinion-orphan-designation-yttrium-90y-antiferritin-polyclonal-antibodies-treatment-hodgkin-lymphoma_en.pdf"},
    {"id":"9687","name":"Bovimectin Injection Article-33 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2014-08-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bovimectin-injection-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"9688","name":"Overview of comments received on 'Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally\n\nauthorised products (CAPs)' (EMA/CVMP/PhVWP/171122/2016)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-06-04T14:00:01Z","last_updated_date":"2018-06-04T14:00:01Z","reference_number":"EMA/CVMP/PhVWP/519126/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-revised-recommendation-basic-surveillance-eudravigilance-veterinary-evvet-data-centrally-authorised-products-caps-emacvmpphvwp1711222016_en.pdf"},
    {"id":"9690","name":"Public statement on Levviax (telithromycin): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-01-25T00:09:21Z","last_updated_date":"2008-01-25T00:09:21Z","reference_number":"EMEA/CHMP/26421/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-levviax-telithromycin-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"9691","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - November 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-12-01T01:00:00Z","last_updated_date":"2010-12-01T01:00:00Z","reference_number":"EMA/CVMP/649372/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-november-2010_en.pdf"},
    {"id":"9692","name":"Resources for issuing treatment recommendation during shortages of medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T00:00:00Z","last_updated_date":"2013-01-29T00:00:00Z","reference_number":"EMA/310484/2013","document_url":"https://www.ema.europa.eu/en/documents/other/resources-issuing-treatment-recommendation-during-shortages-medicinal-products_en.pdf"},
    {"id":"9693","name":"Presentation - Challenges in newborn drug development: US perspective (Jon Davis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-newborn-drug-development-us-perspective-jon-davis_en.pdf"},
    {"id":"9694","name":"Presentation - Orphan medicinal products in the United States: current marketing authorisations for Gaucher disease (Carla Epps)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-28T01:00:00Z","last_updated_date":"2012-11-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orphan-medicinal-products-united-states-current-marketing-authorisations-gaucher-disease-carla-epps_en.pdf"},
    {"id":"9695","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 15–18 August 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-09-05T13:30:00Z","last_updated_date":"2017-09-05T13:30:00Z","reference_number":"EMEA/PDCO/549875/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-15-18-august-2017_en.pdf"},
    {"id":"9696","name":"Opinion following an Article 36(1) referral Gadograf/Gadovist International Non-Proprietary Name (INN): Gadobutrol: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-04-13T02:08:21Z","last_updated_date":"2007-04-13T02:08:21Z","reference_number":"EMEA/508212/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-361-referral-gadografgadovist-international-non-proprietary-name-inn-gadobutrol-background-information_sv.pdf"}},
    {"id":"9697","name":"Presentation - Impact of reimbursement policies on prudent use, availability and pipeline of new antibacterials (Ad Schuurman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-reimbursement-policies-prudent-use-availability-and-pipeline-new-antibacterials-ad-schuurman_en.pdf"},
    {"id":"9699","name":"Withdrawal assessment report for Xegafri","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2016-06-22T02:00:00Z","last_updated_date":"2016-06-22T02:00:00Z","reference_number":"EMA/CHMP/390341/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-xegafri_en.pdf"},
    {"id":"9701","name":"Presentation - 2.3 Some considerations about combining / borrowing evidence in clinical trials for rare disease (Armin Koch, Kristina Weber)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-23-some-considerations-about-combining-borrowing-evidence-clinical-trials-rare-disease-armin-koch-kristina-weber_en.pdf"},
    {"id":"9702","name":"Overview of comments received on draft guideline on user safety for immunological veterinary medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-05-02T02:00:00Z","last_updated_date":"2007-05-02T02:00:00Z","reference_number":"EMEA/145621/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-user-safety-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"9703","name":"Presentation - Do children need adult type trials (J. Taminiau)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-do-children-need-adult-type-trials-j-taminiau_en.pdf"},
    {"id":"9705","name":"Ethinylestradiol-Drospirenone 24+4 Article-6(12) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-i_no.pdf"}},
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    {"id":"9709","name":"Qualification opinion - Total Kidney Volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-13T17:20:02Z","last_updated_date":"2015-11-13T17:20:02Z","reference_number":"EMA/CHMP/SAWP/473433/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-total-kidney-volume-tkv-prognostic-biomarker-use-clinical-trials-evaluating-patients-autosomal-dominant-polycystic-kidney-disease-adpkd_en.pdf"},
    {"id":"9710","name":"Presentation - EMA position on Compliance Check (including validation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-position-compliance-check-including-validation_en.pdf"},
    {"id":"9711","name":"CHMP post-authorisation summary of positive opinion for Velmetia of 23 April 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/240552/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-velmetia-23-april-2009_en.pdf"},
    {"id":"9715","name":"Draft Community herbal monograph on Plantago ovata Forskk., semen","type":"herbal-monograph","status":"Draft","consultation_date":"","first_published_date":"2016-01-21T01:00:00Z","last_updated_date":"2016-01-21T01:00:00Z","reference_number":"EMEA/HMPC/340861/2005","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-plantago-ovata-forskk-semen_en.pdf"},
    {"id":"9717","name":"Work Instructions for new standard term requests to EDQM","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2010-02-18T01:00:00Z","last_updated_date":"2010-02-18T01:00:00Z","reference_number":"WIN/EMA/0108","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-new-standard-term-requests-edqm_en.pdf"},
    {"id":"9719","name":"Draft assessment report on Eschscholzia californica Cham., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-31T19:15:00Z","last_updated_date":"2014-07-31T19:15:00Z","reference_number":"EMA/HMPC/680375/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-eschscholzia-californica-cham-herba_en.pdf"},
    {"id":"9720","name":"Note for guidance on the quality, preclinical and clinical aspects of gene transfer of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-04-24T02:00:00Z","last_updated_date":"2001-04-24T02:00:00Z","reference_number":"CPMP/BWP/3088/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-quality-preclinical-and-clinical-aspects-gene-transfer-medicinal-products_en.pdf"},
    {"id":"9721","name":"CVMP summary of positive opinion for Imrestor","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-10-09T02:00:00Z","last_updated_date":"2015-10-09T02:00:00Z","reference_number":"EMA/CVMP/484431/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-imrestor_en.pdf"},
    {"id":"9723","name":"CHMP summary of positive opinion for Temozolomide Sun","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/354114/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-temozolomide-sun_en.pdf"},
    {"id":"9725","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 20 – 23 October 2014","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/CHMP/SAWP/659072/2014 ","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-20-23-october-2014_en.pdf"},
    {"id":"9731","name":"Presentation - Going digital: Current initiatives (Andrea Johnson, Olivier Simoen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-going-digital-current-initiatives-andrea-johnson-olivier-simoen_en.pdf"},
    {"id":"9732","name":"Opinion of the Committee for proprietary medicinal products pursuant to Article 10 of Council Directive 75/319/EEC as amended","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-08-03T02:08:21Z","last_updated_date":"1998-08-03T02:08:21Z","reference_number":"CPMP/1034/96-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-10-council-directive-75319eec-amended_en.pdf"},
    {"id":"9733","name":"Questions and answers on the review of Ixiaro (Japanese encephalitis vaccine)","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T14:00:00Z","last_updated_date":"2012-03-16T14:00:00Z","reference_number":"EMA/173541/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-ixiaro-japanese-encephalitis-vaccine_en.pdf"},
    {"id":"9734","name":"Questions and answers on the recommendation for the refusal of the marketing authorization for Cimzia","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T01:00:00Z","last_updated_date":"2008-03-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-cimzia_sv.pdf"}},
    {"id":"9736","name":"Human medicines highlights 2016","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2017-01-17T16:00:00Z","last_updated_date":"2017-01-19T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/human-medicines-highlights-2016_en.pdf"},
    {"id":"9737","name":"Recent experience in quality assessment - Sol Ruiz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/recent-experience-quality-assessment-sol-ruiz_en.pdf"},
    {"id":"9740","name":"Final Community herbal monograph on Chamaemelum nobile (L.) All., flos","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T17:20:00Z","last_updated_date":"2012-01-20T17:20:00Z","reference_number":"EMA/HMPC/560734/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"9742","name":"Presentation - Registry initiative - April 2018","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T16:30:00Z","last_updated_date":"2018-05-02T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-registry-initiative-april-2018_en.pdf"},
    {"id":"9743","name":"EU/3/08/543: Public summary of positive opinion for orphan designation of sarsasapogenin for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-28T02:00:00Z","last_updated_date":"2012-09-06T17:34:00Z","reference_number":"EMEA/COMP/202469/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308543-public-summary-positive-opinion-orphan-designation-sarsasapogenin-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"9746","name":"Presentation - Presentation - Biomarkers (Arthur Burghes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-presentation-biomarkers-arthur-burghes_en.pdf"},
    {"id":"9748","name":"Mefloquine: List of nationally authorised medicinal products -    PSUSA/00001955/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T16:28:00Z","last_updated_date":"2018-01-03T16:37:35Z","reference_number":"EMA/845940/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/mefloquine-list-nationally-authorised-medicinal-products-psusa00001955201702_en.pdf"},
    {"id":"9750","name":"Draft community herbal monograph on Primula veris L., Primula elatior (L.) Hill, flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-03-08T01:00:00Z","last_updated_date":"2007-03-08T01:00:00Z","reference_number":"MEA/HMPC/64684/2007 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-primula-veris-l-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"9751","name":"Superseded opinion of the HMPC on a Community herbal monograph on Mentha x piperita L., aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/453712/2007EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-mentha-x-piperita-l-aetheroleum_en.pdf"},
    {"id":"9752","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-09-24T17:54:00Z","last_updated_date":"2012-09-24T17:54:00Z","reference_number":"EMA/CAT/608504/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-september-2012-meeting_en.pdf"},
    {"id":"9755","name":"European Medicines Agency/International Federation for Animal Health Europe info day 2014 announcement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-20T15:00:00Z","last_updated_date":"2014-01-20T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencyinternational-federation-animal-health-europe-info-day-2014-announcement_en.pdf"},
    {"id":"9759","name":"Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T17:00:00Z","last_updated_date":"2016-10-19T17:00:00Z","reference_number":"EMA/661359/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-coagulation-factor-viii-inhibitor-bypassing-fraction-list-nationally-authorised-medicinal-products-psusa00009174201602_en.pdf"},
    {"id":"9762","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - May 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-05-31T02:00:00Z","last_updated_date":"2009-05-31T02:00:00Z","reference_number":"EMEA/CVMP/335565/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-may-2009_en.pdf"},
    {"id":"9765","name":"Draft assessment report on Glycine max (L.) Merr., lecithin","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-07-27T15:40:00Z","last_updated_date":"2016-07-27T15:40:00Z","reference_number":"EMA/HMPC/220598/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-glycine-max-l-merr-lecithin_en.pdf"},
    {"id":"9766","name":"Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-19T12:35:00Z","last_updated_date":"2018-04-26T13:00:00Z","reference_number":"EMA/790351/2017","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-twelfth-industry-stakeholder-platform-operation-pharmacovigilance-european-union_en.pdf"},
    {"id":"9768","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the sixty-seventh meeting of the committee for veterinary medicinal products took place in London on 12-13 June 2001.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-06-14T14:39:21Z","last_updated_date":"2001-06-14T14:39:21Z","reference_number":"EMEA/CVMP/568/01 corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-sixty-seventh-meeting-committee-veterinary-medicinal-products-took-place-london-12-13-june-2001_en.pdf"},
    {"id":"9770","name":"Minutes of the expert meeting on specific immunotherapy","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2011-06-21T02:00:00Z","last_updated_date":"2011-06-21T02:00:00Z","reference_number":"EMA/414476/2011","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-expert-meeting-specific-immunotherapy_en.pdf"},
    {"id":"9774","name":"EU/3/05/323: Public summary of positive opinion for orphan designation of bacterial lipase for the treatment of malabsorption due to exocrine pancreatic enzyme insufficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-02-09T00:00:00Z","last_updated_date":"2006-02-09T00:00:00Z","reference_number":"EMEA/COMP/317739/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305323-public-summary-positive-opinion-orphan-designation-bacterial-lipase-treatment-malabsorption-due-exocrine-pancreatic-enzyme-insufficiency_en.pdf"},
    {"id":"9776","name":"Annual report on a designated orphan medicinal product","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2011-11-24T17:30:00Z","last_updated_date":"2011-12-09T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annual-report-designated-orphan-medicinal-product_en.doc"},
    {"id":"9777","name":"Presentation - Workshop on data requirements for vaccines March 2015: impact on availability (Faye Ioannou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-data-requirements-vaccines-march-2015-impact-availability-faye-ioannou_en.pdf"},
    {"id":"9779","name":"European Medicines Agency recommends withdrawal of medicinal products containing veralipride","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-23T02:00:00Z","last_updated_date":"2007-07-23T02:00:00Z","reference_number":"EMEA/299873/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-withdrawal-medicinal-products-containing-veralipride_en.pdf"},
    {"id":"9780","name":"Opinion of the HMPC on a Community herbal monograph on Fraxinus excelsior L. or Fraxinus angustifolia Vahl, folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:40:00Z","last_updated_date":"2012-06-18T16:40:00Z","reference_number":"EMA/HMPC/216953/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-fraxinus-excelsior-l-or-fraxinus-angustifolia-vahl-folium_en.pdf"},
    {"id":"9782","name":"European Medicines Agency 1995-2015 - Working together for safe and effective medicines","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2015-05-18T18:17:00Z","last_updated_date":"2015-05-18T18:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/european-medicines-agency-1995-2015-working-together-safe-and-effective-medicines_en.pdf"},
    {"id":"9783","name":"Presentation - Working group: Public-private partnership (S. Tansey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-public-private-partnership-s-tansey_en.pdf"},
    {"id":"9785","name":"Draft guideline on comparability of biotechnology-derived medicinal products after a change in the manufacturing process. Non-clinical and clinical issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"EMEA/CHMP/BMWP/101695/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-comparability-biotechnology-derived-medicinal-products-after-change-manufacturing-process-non-clinical-and-clinical-issues_en.pdf"},
    {"id":"9786","name":"European Medicines Agency: Clarification Questions - 2 October 2006","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-10-02T02:00:00Z","last_updated_date":"2006-10-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-clarification-questions-2-october-2006_en.pdf"},
    {"id":"9787","name":"CHMP post-authorisation summary of positive opinion for Remicade","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T11:00:00Z","last_updated_date":"2012-01-20T11:00:00Z","reference_number":"EMA/CHMP/31386/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-remicade_en.pdf"},
    {"id":"9789","name":"Presentation - Dose - response - anticoagulants (Robert Temple)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-response-anticoagulants-robert-temple_en.pdf"},
    {"id":"9790","name":"Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-23T19:31:00Z","last_updated_date":"2017-02-23T19:31:00Z","reference_number":"EMA/101726/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproteroneethinylestradiol-prac-non-interventional-imposed-pass-final-study-report-assessment-report-emeahnpsrj0005_en.pdf"},
    {"id":"9791","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products extraordinary meeting, 3 September 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-09-04T02:09:21Z","last_updated_date":"2003-09-04T02:09:21Z","reference_number":"EMEA/23230/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-extraordinary-meeting-3-september-2003_en.pdf"},
    {"id":"9792","name":"Questions and answers on the withdrawal of the marketing application for Aquilda","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-06-09T02:00:00Z","last_updated_date":"2008-06-09T02:00:00Z","reference_number":"EMEA/277960/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-aquilda_en.pdf"},
    {"id":"9793","name":"Presentation - Objectives and problem statement (Janina Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-and-problem-statement-janina-karres_en.pdf"},
    {"id":"9797","name":"EU/3/05/335: Public summary of positive opinion for orphan designation of human Staphylococcus aureus polyclonal immunoglobulin and human Staphylococcus epidermidis polyclonal immunoglobulin for the prevention of late on...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/367733/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305335-public-summary-positive-opinion-orphan-designation-human-staphylococcus-aureus-polyclonal-immunoglobulin-and-human-staphylococcus-epidermidis-polyclonal-immunoglobulin-prevention-late_en.pdf"},
    {"id":"9798","name":"Three years of successful experience on orphan drugs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-04-28T02:00:00Z","last_updated_date":"2004-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/three-years-successful-experience-orphan-drugs_en.pdf"},
    {"id":"9799","name":"Questions and answers on the review of pioglitazone-containing medicines (Actos, Glustin, Competact, Glubrava and Tandemact)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-07-21T02:00:00Z","last_updated_date":"2011-07-21T02:00:00Z","reference_number":"EMA/CHMP/562496/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-pioglitazone-containing-medicines-actos-glustin-competact-glubrava-and-tandemact_en.pdf"},
    {"id":"9801","name":"CHMP summary of positive opinion for Taltz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T13:05:00Z","last_updated_date":"2016-02-26T13:05:00Z","reference_number":"EMA/CHMP/78341/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-taltz_en.pdf"},
    {"id":"9803","name":"EU/3/09/676: Public summary of positive opinion for orphan designation of sequence-modified recombinant human factor VIIa for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2016-01-19T13:30:00Z","reference_number":"EMEA/COMP/462126/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309676-public-summary-positive-opinion-orphan-designation-sequence-modified-recombinant-human-factor-viia-treatment-haemophilia-b_en.pdf"},
    {"id":"9805","name":"Goserelin Cell Pharm - Article 36 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/goserelin-cell-pharm-article-36-referral-annex-iii_sv.pdf"}},
    {"id":"9806","name":"EU/3/13/1228: Public summary of opinion on orphan designation: Obeticholic acid for the treatment of primary sclerosing cholangitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2022-05-10T01:00:00Z","reference_number":"EMA/COMP/18109/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131228-public-summary-opinion-orphan-designation-obeticholic-acid-treatment-primary-sclerosing-cholangitis_en.pdf"},
    {"id":"9807","name":"Levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001856/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-24T01:00:00Z","last_updated_date":"2016-10-18T10:40:13Z","reference_number":"EMA/589993/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/levonorgestrel-list-nationally-authorised-medicinal-products-psusa00001856201412_en.pdf"},
    {"id":"9808","name":"CVMP summary of positive opinion for Suvaxyn Circo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"EMA/CVMP/757567/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-suvaxyn-circo_en.pdf"},
    {"id":"9809","name":"Transparency at the MEB: a necessity","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/transparency-meb-necessity_en.pdf"},
    {"id":"9813","name":"European Medicines Agency recommends approval of two new treatment options for rare cancers","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-07-25T14:00:00Z","last_updated_date":"2014-07-25T14:00:00Z","reference_number":"EMA/448634/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-two-new-treatment-options-rare-cancers_en.pdf"},
    {"id":"9814","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimi...","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-09-05T14:30:00Z","last_updated_date":"2017-10-09T13:30:00Z","reference_number":"EMA/765134/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-info-session_en.pdf"},
    {"id":"9815","name":"Tripartite Meeting (JPMA/PhRMA/EBC-PC) hosted by EMEA: 'Approving Innovative Medicines in 21st Century'","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-05-30T02:00:00Z","last_updated_date":"2000-05-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/tripartite-meeting-jpmaphrmaebc-pc-hosted-emea-approving-innovative-medicines-21st-century_en.pdf"},
    {"id":"9817","name":"Initial notices for parallel distribution – 2011","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-10-10T17:00:00Z","last_updated_date":"2012-10-10T17:00:00Z","reference_number":"EMA/643088/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2011_en.pdf"},
    {"id":"9819","name":"Annex 10 - 2015 annual report of the European Medicines Agency - Positive and negative opinions; Withdrawn applications","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2016-05-17T18:00:00Z","last_updated_date":"2016-05-17T18:00:00Z","reference_number":"EMA/156961/2016","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annex-10-2015-annual-report-european-medicines-agency-positive-and-negative-opinions-withdrawn-applications_en.xlsx"},
    {"id":"9821","name":"Assessment report for Leflunomide Apotex","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"EMA/691570/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-leflunomide-apotex_en.pdf"},
    {"id":"9823","name":"Bromocriptine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-02T02:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bromocriptine-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bromocriptine-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bromocriptine-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bromocriptine-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bromocriptine-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bromocriptine-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bromocriptine-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bromocriptine-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/bromocriptine-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bromocriptine-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bromocriptine-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bromocriptine-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bromocriptine-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bromocriptine-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bromocriptine-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bromocriptine-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bromocriptine-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bromocriptine-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bromocriptine-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bromocriptine-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bromocriptine-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bromocriptine-article-31-referral-annex-i_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/bromocriptine-article-31-referral-annex-i_no.pdf"}},
    {"id":"9826","name":"Amitraz (cattle and sheep): Summary report (2)  – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/330/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/amitraz-cattle-and-sheep-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9828","name":"CHMP post-authorisation summary of positive opinion for Simponi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/CHMP/295989/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-simponi_en.pdf"},
    {"id":"9829","name":"Simvastatin Vale Article-29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T02:00:00Z","last_updated_date":"2013-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/simvastatin-vale-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/simvastatin-vale-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/simvastatin-vale-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/simvastatin-vale-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/simvastatin-vale-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/simvastatin-vale-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/simvastatin-vale-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/simvastatin-vale-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/simvastatin-vale-article-294-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/simvastatin-vale-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/simvastatin-vale-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/simvastatin-vale-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/simvastatin-vale-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/simvastatin-vale-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/simvastatin-vale-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/simvastatin-vale-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/simvastatin-vale-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/simvastatin-vale-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/simvastatin-vale-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/simvastatin-vale-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/simvastatin-vale-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/simvastatin-vale-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"9833","name":"Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Cymbalta / Xeristar","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:00:00Z","last_updated_date":"2021-06-22T14:29:00Z","reference_number":"EMEA/551181/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-cymbalta-xeristar_sv.pdf"}},
    {"id":"9834","name":"Technical specifications for open invitation to tender - Supply, installation and maintenance of audiovisual equipment and consumables including on-site technical support - EMA/2012/21/IS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-12T09:50:00Z","last_updated_date":"2012-11-30T09:50:00Z","reference_number":"EMA/565757/2012","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-open-invitation-tender-supply-installation-and-maintenance-audiovisual-equipment-and-consumables-including-site-technical-support-ema201221is_en.pdf"},
    {"id":"9835","name":"Overview of comments received on 'Draft imatinib product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-04-10T15:28:00Z","last_updated_date":"2015-04-10T15:28:00Z","reference_number":"EMA/CHMP/116042/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-imatinib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"9836","name":"CHMP summary of positive opinion for Tecentriq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/CHMP/372183/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tecentriq_en.pdf"},
    {"id":"9837","name":"Capsicum - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"EMA/HMPC/331421/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/capsicum-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/capsicum-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/capsicum-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/capsicum-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/capsicum-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/capsicum-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/capsicum-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/capsicum-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/capsicum-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/capsicum-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/capsicum-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/capsicum-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/capsicum-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/capsicum-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/capsicum-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/capsicum-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/capsicum-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/capsicum-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/capsicum-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/capsicum-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/capsicum-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/capsicum-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/capsicum-summary-public_sv.pdf"}},
    {"id":"9838","name":"Committee for medicinal products for veterinary use -\n\nEMEA public bulletin 2007 on veterinary pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-02-18T01:00:00Z","last_updated_date":"2008-02-18T01:00:00Z","reference_number":"EMEA/CVMP/PhVWP/72829/2007","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-emea-public-bulletin-2007-veterinary-pharmacovigilance_en.pdf"},
    {"id":"9841","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cometriq (cabozantinib) for the treatment of medullary thyroid carcinoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"EMA/COMP/4640/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-cometriq-cabozantinib-treatment-medullary-thyroid-carcinoma_en.pdf"},
    {"id":"9842","name":"Presentation - Module 3 - Early engagement on medicine development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-3-early-engagement-medicine-development_en.pdf"},
    {"id":"9844","name":"Cooperation on medicines regulation intensified","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-14T01:00:00Z","last_updated_date":"2006-03-14T01:00:00Z","reference_number":"EMEA/93090/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/cooperation-medicines-regulation-intensified_en.pdf"},
    {"id":"9846","name":"Questions and answers on vaccines for the H1N1 ('swine flu') pandemic","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-07-24T02:09:21Z","last_updated_date":"2009-07-24T02:09:21Z","reference_number":"EMEA/461476/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-vaccines-h1n1-swine-flu-pandemic_en.pdf"},
    {"id":"9847","name":"Overview of comments received on draft ESVAC reflection paper on collecting data on consumption of antimicrobial agents per animal species, on technical units of measurement and indicators for reporting consumption of an...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-15T16:35:00Z","last_updated_date":"2013-10-15T16:35:00Z","reference_number":"EMA/171117/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-esvac-reflection-paper-collecting-data-consumption-antimicrobial-agents-animal-species-technical-units-measurement-and-indicators-reporting-consumption_en.pdf"},
    {"id":"9850","name":"Aminosidine: Summary report (1)  – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-11-28T01:00:00Z","last_updated_date":"2000-11-28T01:00:00Z","reference_number":"EMEA/MRL/050/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/aminosidine-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9853","name":"Minutes of the Patients’ and Consumers’ Working Party and Healthcare Professionals Working Party joint meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-12-11T10:30:00Z","last_updated_date":"2013-12-11T10:30:00Z","reference_number":"EMA/618027/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-patients-and-consumers-working-party-and-healthcare-professionals-working-party-joint-meeting_en.pdf"},
    {"id":"9854","name":"Presentation - Data retrieval using the new standardised medical  dictionary for regulatory activities queries (SMQs) medication errors (Christina Winter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-01T01:00:00Z","last_updated_date":"2017-03-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-retrieval-using-new-standardised-medical-dictionary-regulatory-activities-queries-smqs-medication-errors-christina-winter_en.pdf"},
    {"id":"9856","name":"Time allowed for applicants to respond to questions and issues raised during the assessment of new marketing authorisation applications in the centralised procedure","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-01-06T01:00:00Z","last_updated_date":"2009-01-06T01:00:00Z","reference_number":"EMEA/75401/2006 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/time-allowed-applicants-respond-questions-and-issues-raised-during-assessment-new-marketing-authorisation-applications-centralised-procedure_en.pdf"},
    {"id":"9857","name":"Workshop on multiplicity issues in clinical trials: Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"EMA/743074/2012","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-multiplicity-issues-clinical-trials-report_en.pdf"},
    {"id":"9858","name":"CHMP summary of positive opinion for Repso","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/CHMP/605155/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-repso_en.pdf"},
    {"id":"9859","name":"Codeine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-08-02T02:00:00Z","last_updated_date":"2013-08-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/codeine-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/codeine-article-31-referral-annex-i_no.pdf"}},
    {"id":"9860","name":"Baclofen (oral): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - 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    {"id":"9863","name":"Guideline on specific efficacy requirements for ectoparasiticides in cattle","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-07-23T02:00:00Z","last_updated_date":"2004-07-23T02:00:00Z","reference_number":"EMEA/CVMP/625/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-specific-efficacy-requirements-ectoparasiticides-cattle_en.pdf"},
    {"id":"9865","name":"Final Community herbal monograph on Melissa officinalis L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-08-05T17:00:00Z","last_updated_date":"2013-08-05T17:00:00Z","reference_number":"EMA/HMPC/196745/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-melissa-officinalis-l-folium_en.pdf"},
    {"id":"9867","name":"Implementation of the action plan to further progress the european risk management strategy: rolling two-year work programme (mid 2005-mid 2007)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-12-16T00:00:00Z","last_updated_date":"2005-12-16T00:00:00Z","reference_number":"EMEA/372687/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/implementation-action-plan-further-progress-european-risk-management-strategy-rolling-two-year-work-programme-mid-2005-mid-2007_en.pdf"},
    {"id":"9871","name":"Ibuprofen and dexibuprofen Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T17:00:00Z","last_updated_date":"2014-06-13T17:00:00Z","reference_number":"EMA/348597/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-review-started_en.pdf"},
    {"id":"9874","name":"Presentation - Safety of new products: do we have enough tools in place? (Flora Peyvandi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-safety-new-products-do-we-have-enough-tools-place-flora-peyvandi_en.pdf"},
    {"id":"9875","name":"Overview of comments received on reflection paper on publication of the CVMP’s negative opinion and refusal to recommend the granting of a marketing authorisation for veterinary medicinal  products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-07-12T02:00:00Z","last_updated_date":"2007-07-12T02:00:00Z","reference_number":"EMEA/CVMP/247827/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-publication-cvmps-negative-opinion-and-refusal-recommend-granting-marketing-authorisation-veterinary-medicinal-products_en.pdf"},
    {"id":"9876","name":"Committee for Advanced Therapies (CAT): September 2010 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-10-04T02:00:00Z","last_updated_date":"2010-10-04T02:00:00Z","reference_number":"EMA/CAT/601590/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-september-2010-meeting-monthly-report_en.pdf"},
    {"id":"9878","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose derived regenerative mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/4172015/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-autologous-adipose-derived-regenerative-mesenchymal-stem-cells_en.pdf"},
    {"id":"9880","name":"Final European Union herbal monograph on Matricaria recutita L., aetheroleum - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-04-05T02:00:00Z","last_updated_date":"2016-04-05T02:00:00Z","reference_number":"EMA/HMPC/278814/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-matricaria-recutita-l-aetheroleum-first-version_en.pdf"},
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    {"id":"9885","name":"CHMP summary of positive opinion for Pioglitazone Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2023-05-04T01:00:00Z","reference_number":"EMA/CHMP/756122/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pioglitazone-teva_en.pdf"},
    {"id":"9887","name":"Workshop on medicines for bees - Background document","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-12-11T00:09:21Z","last_updated_date":"2009-12-11T00:09:21Z","reference_number":"EMA/794320/2009","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-medicines-bees-background-document_en.pdf"},
    {"id":"9893","name":"Imidocarb (Extension to sheep): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2003-07-01T02:00:00Z","last_updated_date":"2003-07-01T02:00:00Z","reference_number":"EMEA/MRL/881/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/imidocarb-extension-sheep-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"9895","name":"Presentation - Diagnostic criteria for neuromyelitis optica 2014 (Brian G. Weinshenker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-diagnostic-criteria-neuromyelitis-optica-2014-brian-g-weinshenker_en.pdf"},
    {"id":"9898","name":"News bulletin for small and medium-sized enterprises - Issue 34","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T17:00:00Z","last_updated_date":"2016-01-25T17:00:00Z","reference_number":"Issue 34","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-34_en.pdf"},
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    {"id":"9904","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: workshop on risk minim...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T15:05:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"EMA/292901/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-workshop-risk_en.pdf"},
    {"id":"9905","name":"Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-02-16T01:00:00Z","last_updated_date":"2009-02-16T01:00:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/17760/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-near-infrared-spectroscopy-pharmaceutical-industry-and-data-requirements-new-submissions-and-variations-revision-1_en.pdf"},
    {"id":"9907","name":"European Medicines Agency recommends approval of new HIV medicine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/715767/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-new-hiv-medicine_en.pdf"},
    {"id":"9908","name":"CVMP post-authorisation summary of positive opinion for ZactranIII","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"EMA/CVMP/763148/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-zactraniii_en.pdf"},
    {"id":"9910","name":"Ziprasidone: List of nationally authorised medicinal products - PSUSA/00003146/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-11T14:00:00Z","last_updated_date":"2016-10-17T20:16:33Z","reference_number":"EMA/257007/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ziprasidone-list-nationally-authorised-medicinal-products-psusa00003146201507_en.pdf"},
    {"id":"9911","name":"Draft guideline on the clinical investigation of recombinant and human plasma-derived factor IX products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/BPWP/144552/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-ix-products_en.pdf"},
    {"id":"9914","name":"Overview of comments received on 'Guideline on user safety of topically administered veterinary medicinal products'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-05-07T13:45:00Z","last_updated_date":"2018-05-07T13:45:00Z","reference_number":"EMA/CVMP/SWP/30675/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-user-safety-topically-administered-veterinary-medicinal-products_en.pdf"},
    {"id":"9915","name":"CVMP summary of positive opinion for Recuvyra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-06T02:00:00Z","last_updated_date":"2017-07-12T02:00:00Z","reference_number":"EMA/CVMP/62249/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-recuvyra_en.pdf"},
    {"id":"9916","name":"EU/3/01/046: Public summary of positive opinion for orphan designation of thalidomide for the treatment of graft versus host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/1289/2003 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301046-public-summary-positive-opinion-orphan-designation-thalidomide-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"9917","name":"Opinion of the Committee for Medicinal Products for Veterinary Use regarding a request pursuant to Article-30(3) of Regulation (EC) No 726/2004 in relation to the potential risk for the consumer resulting from the use of...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-22T14:00:00Z","last_updated_date":"2015-04-22T14:00:00Z","reference_number":"EMA/CVMP/124059/2015","document_url":"https://www.ema.europa.eu/en/documents/other/opinion-committee-medicinal-products-veterinary-use-regarding-request-pursuant-article-303-regulation-ec-no-7262004-relation-potential-risk-consumer-resulting-use_en.pdf"},
    {"id":"9918","name":"Draft community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-01-10T01:00:00Z","last_updated_date":"2008-01-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"9919","name":"Qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-02-10T10:20:00Z","last_updated_date":"2014-02-10T10:20:00Z","reference_number":"EMA/CHMP/SAWP/757052/2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-mcp-mod-efficient-statistical-methodology-model-based-design-and-analysis-phase-ii-dose-finding-studies-under-model-uncertainty_en.pdf"},
    {"id":"9921","name":"Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-05-17T02:00:00Z","last_updated_date":"2011-05-17T02:00:00Z","reference_number":"EMA/CVMP/EWP/459868/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-demonstration-target-animal-safety-and-efficacy-veterinary-medicinal-products-intended-use-farmed-finfish_en.pdf"},
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    {"id":"9923","name":"Butafosfan: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/630/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/butafosfan-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"9934","name":"Draft list of references for assessment of: Salicis cortex Salix sp (willow bark)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-09-07T02:00:00Z","last_updated_date":"2007-09-07T02:00:00Z","reference_number":"EMEA/HMPC/394997/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-salicis-cortex-salix-sp-willow-bark_en.pdf"},
    {"id":"9939","name":"Letter from the European Union to Japan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-union-japan_en.pdf"},
    {"id":"9941","name":"CHMP ORGAM agenda for the meeting on 3 October 2016","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-10-04T18:00:00Z","last_updated_date":"2016-10-04T18:00:00Z","reference_number":"EMA/CHMP/620067/2016 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-3-october-2016_en.pdf"},
    {"id":"9943","name":"Presentation - Minor Use / Minor Species policy industry feedback (Alexander Bà¶ttner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-minor-use-minor-species-policy-industry-feedback-alexander-bapttner_en.pdf"},
    {"id":"9944","name":"Superseded opinion of the HMPC on a Community herbal monograph on Juniperi pseudo-fructus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-02-16T01:00:00Z","last_updated_date":"2023-06-13T01:00:00Z","reference_number":"EMA/HMPC/678925/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-juniperi-pseudo-fructus_en.pdf"},
    {"id":"9945","name":"EP RUMA - turning aspiration into reality - Declan O' Brien","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ep-ruma-turning-aspiration-reality-declan-o-brien_en.pdf"},
    {"id":"9947","name":"Final assessment report on Carum carvi L., fructus and Carum carvi L., aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/HMPC/715093/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-carum-carvi-l-fructus-and-carum-carvi-l-aetheroleum_en.pdf"},
    {"id":"9948","name":"Etopophos Article-30 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-14T18:00:00Z","last_updated_date":"2017-07-14T18:00:00Z","reference_number":"EMA/409209/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/etopophos-article-30-referral-chmp-assessment-report_en.pdf"},
    {"id":"9950","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells in autologous cell-enriched matrix for subcutaneous administration","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T18:00:00Z","last_updated_date":"2013-05-03T18:00:00Z","reference_number":"EMA/129099/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adult-autologous-regenerative-cells-autologous-cell-enriched-matrix-subcutaneous-administration_en.pdf"},
    {"id":"9951","name":"Public statement on the withdrawal of the marketing authorisation in the European Union for Tekturna (aliskiren)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-09-10T02:00:00Z","last_updated_date":"2009-09-10T02:00:00Z","reference_number":"EMEA/575961/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-withdrawal-marketing-authorisation-european-union-tekturna-aliskiren_en.pdf"},
    {"id":"9952","name":"Questions and answers on HBVAXPRO and Procomvax","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-05-04T02:00:00Z","last_updated_date":"2006-05-04T02:00:00Z","reference_number":"EMEA/CHMP/153090/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-hbvaxpro-and-procomvax_en.pdf"},
    {"id":"9959","name":"EU/3/17/1943: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype 9 containing human iduronate-2-sulfatase gene for the treatment of mucopolysaccharidosis type II (Hunter’s...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/694657/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171943-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-9-containing-human-iduronate-2-sulfatase-gene-treatment-mucopolysaccharidosis-type-ii-hunters_en.pdf"},
    {"id":"9961","name":"Ergot derivatives Article-31 referral - Dihydroergotoxine - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-ii_sv.pdf"}},
    {"id":"9962","name":"European Agency for the Evaluation of Medicinal Products: EudraLink Launch meeting 28-29 January 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-02-05T01:00:00Z","last_updated_date":"2003-02-05T01:00:00Z","reference_number":"EMEA/7542/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-eudralink-launch-meeting-28-29-january-2003_en.pdf"},
    {"id":"9963","name":"EudraGMP 2.0 gives public access to information about Good Manufacturing Practice (GMP)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-08-04T02:00:00Z","last_updated_date":"2009-08-04T02:00:00Z","reference_number":"EMEA/494112/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/eudragmp-20-gives-public-access-information-about-good-manufacturing-practice-gmp_en.pdf"},
    {"id":"9965","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-28 March 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-04-10T12:06:17Z","last_updated_date":"2017-04-10T12:06:17Z","reference_number":"EMA/HMPC/224698/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-27-28-march-2017_en.pdf"},
    {"id":"9967","name":"Monthly Report - Pharmacovigilance Working Party (PhVWP) February 2010 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"EMA/102067/2010","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-february-2010-plenary-meeting_en.pdf"},
    {"id":"9968","name":"Joint TAIEX/EMEA Central Eastern European Countries Forum on the regulation of veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1999-06-18T14:09:21Z","last_updated_date":"1999-06-18T14:09:21Z","reference_number":"EMEA/V/PHJ/wjp/18613/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/joint-taiexemea-central-eastern-european-countries-forum-regulation-veterinary-medicinal-products_en.pdf"},
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    {"id":"9976","name":"Agenda - Eighth industry stakeholder platform: operation of EU pharmacovigilance legislation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T16:15:00Z","last_updated_date":"2016-08-15T16:15:00Z","reference_number":"EMA/375852/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eighth-industry-stakeholder-platform-operation-eu-pharmacovigilance-legislation_en.pdf"},
    {"id":"9978","name":"Presentation - Nanomedicines - Current initiatives in Canada, Duc Vu, Health Canada","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nanomedicines-current-initiatives-canada-duc-vu-health-canada_en.pdf"},
    {"id":"9979","name":"Technical Specifications - Annex III Summary checklist of documents, which tenderers must submit: Procurement procedure EMA/2014/01/PH","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-iii-summary-checklist-documents-which-tenderers-must-submit-procurement-procedure-ema201401ph_en.pdf"},
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    {"id":"9982","name":"Bovilis BVD/Bovilis BVD-MD - Article 33 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-16T00:59:00Z","last_updated_date":"2007-11-16T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bovilis-bvdbovilis-bvd-md-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"9985","name":"The role of the Paediatric Committee and short history of previous activities - Dr Paolo Rossi","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/role-paediatric-committee-and-short-history-previous-activities-dr-paolo-rossi_en.pdf"},
    {"id":"9988","name":"Cathal Gallagher (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cathal-gallagher-doi_en.pdf"},
    {"id":"9990","name":"Influenza vaccine (surface antigen, inactivated, adjuvanted): List of nationally authorised medicinal products - PSUSA/00010300/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-17T18:39:11Z","reference_number":"EMA/346553/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-adjuvanted-list-nationally-authorised-medicinal-products-psusa00010300201508_en.pdf"},
    {"id":"9992","name":"Public Statement: Epoetins and the risk of tumour growth progression and thromboembolic events in cancer patients and cardiovascular risks in patients with chronic kidney disease","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-10-23T02:09:21Z","last_updated_date":"2007-10-23T02:09:21Z","reference_number":"EMEA/496188/2007","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-epoetins-and-risk-tumour-growth-progression-and-thromboembolic-events-cancer-patients-and-cardiovascular-risks-patients-chronic-kidney-disease_en.pdf"},
    {"id":"9994","name":"European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-25T01:00:00Z","last_updated_date":"2010-03-25T01:00:00Z","reference_number":"EMA/179606/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-precautionary-recall-batches-clopidogrel-containing-medicines-acino-pharma-gmbh_en.pdf"},
    {"id":"9995","name":"EU/3/18/2021: Public summary of opinion on orphan designation: Equine immunoglobulin F(ab’)2 fragments targeting Shiga toxin for the prevention of haemolytic uraemic syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-24T11:27:00Z","last_updated_date":"2018-07-24T11:27:00Z","reference_number":"EMA/265927/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182021-public-summary-opinion-orphan-designation-equine-immunoglobulin-fab2-fragments-targeting-shiga-toxin-prevention-haemolytic-uraemic-syndrome_en.pdf"},
    {"id":"9996","name":"Agenda - Adaptive pathways workshop","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-09-07T02:00:00Z","last_updated_date":"2016-12-07T15:00:00Z","reference_number":"EMA/594912/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-adaptive-pathways-workshop_en.pdf"},
    {"id":"9997","name":"EU/3/11/903: Public summary of opinion on orphan designation: Genetically modified Lactococcus lactis bacteria containing the human trefoil factor 1 gene for the prevention of oral mucositis in head and neck cancer patie...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/COMP/659769/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311903-public-summary-opinion-orphan-designation-genetically-modified-lactococcus-lactis-bacteria-containing-human-trefoil-factor-1-gene-prevention-oral-mucositis-head-and-neck-cancer-patie_en.pdf"},
    {"id":"9998","name":"Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 1) (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T02:00:00Z","last_updated_date":"2012-06-25T02:00:00Z","reference_number":"EMA/873138/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-vi-management-and-reporting-adverse-reactions-medicinal-products-rev-1-superseded_en.pdf"},
    {"id":"9999","name":"Draft guideline on the quality aspects of single-dose veterinary spot-on products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-12-20T01:00:00Z","last_updated_date":"2007-12-20T01:00:00Z","reference_number":"EMEA/CVMP/QWP/544461/2007-CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-single-dose-veterinary-spot-products_en.pdf"},
    {"id":"10001","name":"EMA reviewing risk of dosing errors with methotrexate","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2018-04-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-reviewing-risk-dosing-errors-methotrexate_en.pdf"},
    {"id":"10002","name":"Overview of comments received during the second public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinar...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-09-17T18:05:01Z","last_updated_date":"2015-09-17T18:05:01Z","reference_number":"EMA/CVMP/ERA/74265/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-during-second-public-consultation-guidance-assessment-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpvb-substances-veterinar_en.pdf"},
    {"id":"10005","name":"Guerbet withdraws its marketing authorisation application for Sinerem","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T01:00:00Z","last_updated_date":"2007-12-14T01:00:00Z","reference_number":"EMEA/594122/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/guerbet-withdraws-its-marketing-authorisation-application-sinerem_en.pdf"},
    {"id":"10008","name":"Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/427636/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/studies-alkem-laboratories-ltd-cannot-be-used-support-medicines-approval-eu_en.pdf"},
    {"id":"10010","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Greg Perry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-greg-perry_en.pdf"},
    {"id":"10011","name":"Presentation - The importance of D-E-R characterisation in dose selection, labelling and B/R - children (Dirk Mentzer, Ine Rusten)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-importance-d-e-r-characterisation-dose-selection-labelling-and-br-children-dirk-mentzer-ine-rusten_en.pdf"},
    {"id":"10012","name":"CHMP summary of positive opinion for Brilique","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2010-09-24T02:00:00Z","reference_number":"EMA/536945/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-brilique_en.pdf"},
    {"id":"10014","name":"Guidelines and concept papers adopted during the CHMP meeting 19-22 October 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-10-30T15:45:00Z","last_updated_date":"2015-10-30T15:45:00Z","reference_number":"EMA/38687/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-19-22-october-2015_en.pdf"},
    {"id":"10017","name":"EU/3/07/447: Public summary of positive opinion for orphan designation of \n\nnilotinib hydrochloride monohydrate for the treatment of gastrointestinal stromal tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2015-02-10T01:00:00Z","reference_number":"EMA/COMP/93604/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307447-public-summary-positive-opinion-orphan-designation-nilotinib-hydrochloride-monohydrate-treatment-gastrointestinal-stromal-tumours_en.pdf"},
    {"id":"10020","name":"Influenza vaccine (surface antigen, inactivated, adjuvanted): List of nationally authorised medicinal products - PSUSA/00010300/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T15:22:01Z","reference_number":"EMA/751345/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-adjuvanted-list-nationally-authorised-medicinal-products-psusa00010300201603_en.pdf"},
    {"id":"10027","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Glybera (alipogene tiparvovec) for the treatment of lipoprotein-lipase deficiency","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-12-03T12:58:00Z","last_updated_date":"2021-05-31T12:58:00Z","reference_number":"EMA/571233/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-glybera-alipogene-tiparvovec-treatment-lipoprotein-lipase-deficiency_en.pdf"},
    {"id":"10029","name":"EMEA experience in oncology drug approval - Francesco Pignatti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-12-16T00:09:21Z","last_updated_date":"2005-12-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-experience-oncology-drug-approval-francesco-pignatti_en.pdf"},
    {"id":"10030","name":"Superseded assessment report on Plantago ovata Forssk., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/166377/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-plantago-ovata-forssk-semen_en.pdf"},
    {"id":"10032","name":"Fusafungine Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-04-14T02:00:00Z","last_updated_date":"2016-04-14T02:00:00Z","reference_number":"EMA/194153/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-assessment-report_en.pdf"},
    {"id":"10033","name":"Guidance on format of the risk-management plan in the European Union part IV: Plans for post-authorisation efficacy studies","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2012-11-08T18:00:00Z","reference_number":"EMA/712370/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-iv-plans-post-authorisation-efficacy-studies_en.pdf"},
    {"id":"10036","name":"Losec - Article 30 referrals - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-01-23T00:59:00Z","last_updated_date":"2011-09-20T01:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/losec-article-30-referrals-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/losec-article-30-referrals-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/losec-article-30-referrals-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/losec-article-30-referrals-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/losec-article-30-referrals-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/losec-article-30-referrals-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/losec-article-30-referrals-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/losec-article-30-referrals-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/losec-article-30-referrals-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/losec-article-30-referrals-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/losec-article-30-referrals-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/losec-article-30-referrals-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/losec-article-30-referrals-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/losec-article-30-referrals-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/losec-article-30-referrals-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/losec-article-30-referrals-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/losec-article-30-referrals-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/losec-article-30-referrals-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/losec-article-30-referrals-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/losec-article-30-referrals-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/losec-article-30-referrals-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/losec-article-30-referrals-annex-iii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/losec-article-30-referrals-annex-iii_no.pdf"}},
    {"id":"10037","name":"Girolan Article-34 referral - Divergent position 1","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-15T02:00:00Z","last_updated_date":"2018-06-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/girolan-article-34-referral-divergent-position-1_en.pdf"},
    {"id":"10038","name":"Presentation - Implementation of new eligibility requirements and working party mandates for 2016-2019 (Nathalie Bere and Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-new-eligibility-requirements-and-working-party-mandates-2016-2019-nathalie-bere-and-ivana-silva_en.pdf"},
    {"id":"10039","name":"Presentation - EBG’s perspective on the draft guideline on the non-clinical/clinical issues (Mark McCamish)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ebgs-perspective-draft-guideline-non-clinicalclinical-issues-mark-mccamish_en.pdf"},
    {"id":"10040","name":"Start of community reviews adopted at the Committee for Medicinal Products for Human Use meeting of 17-20 October 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-21T14:01:00Z","last_updated_date":"2011-10-21T14:01:00Z","reference_number":"EMA/851133/2011","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-adopted-committee-medicinal-products-human-use-meeting-17-20-october-2011_en.pdf"},
    {"id":"10041","name":"Bayer Schering Pharma withdraws its marketing authorisation application for Recothrom (thrombin alfa)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-14T01:00:00Z","last_updated_date":"2009-12-14T01:00:00Z","reference_number":"EMA/812456/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/bayer-schering-pharma-withdraws-its-marketing-authorisation-application-recothrom-thrombin-alfa_en.pdf"},
    {"id":"10043","name":"Dienogest / estradiol (HRT indication): List of nationally authorised medicinal products - PSUSA/00010443/201606","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-22T12:00:00Z","last_updated_date":"2017-02-22T12:14:26Z","reference_number":"EMA/127587/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/dienogest-estradiol-hrt-indication-list-nationally-authorised-medicinal-products-psusa00010443201606_en.pdf"},
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    {"id":"10047","name":"Doxazosin Retard \"Arrow\" 4 mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-10-11T02:08:21Z","last_updated_date":"2006-10-11T02:08:21Z","reference_number":"CHMP/423796/06","document_url":"https://www.ema.europa.eu/en/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/doxazosin-retard-arrow-4-mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"10049","name":"Levobunolol (ophthalmic indication): List of nationally authorised medicinal products - PSUSA/00010109/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T12:35:00Z","last_updated_date":"2017-10-23T12:40:00Z","reference_number":"EMA/699912/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/levobunolol-ophthalmic-indication-list-nationally-authorised-medicinal-products-psusa00010109201701_en.pdf"},
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    {"id":"10053","name":"Assessment of the paediatric needs - Rheumatology","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-06-02T02:00:00Z","last_updated_date":"2006-06-02T02:00:00Z","reference_number":"EMEA/CHMP/234105/2005","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-rheumatology_en.pdf"},
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    {"id":"10057","name":"Programme - SME workshop: Focus on quality for medicines containing chemical entities","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-sme-workshop-focus-quality-medicines-containing-chemical-entities_en.pdf"},
    {"id":"10058","name":"EudraVigilance access policy for medicines for human use","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-07-08T17:50:18Z","last_updated_date":"2011-08-23T17:00:00Z","reference_number":"EMA/759287/2009","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-access-policy-medicines-human-use_en.pdf"},
    {"id":"10062","name":"Presentation - Post-authorisation safety studies and the European Union post-authorisation-safety-study register (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-post-authorisation-safety-studies-and-european-union-post-authorisation-safety-study-register-xavier-kurz_en.pdf"},
    {"id":"10063","name":"EU/3/16/1707: Public summary of opinion on orphan designation: Sodium benzoate for the treatment of citrullinaemia type 1","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/450240/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161707-public-summary-opinion-orphan-designation-sodium-benzoate-treatment-citrullinaemia-type-1_en.pdf"},
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    {"id":"10067","name":"Diphtheria/tetanus/pertussis (acellular, component) vaccine (adsorbed), diphtheria/tetanus/pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents:List of nationally authorised medicinal pr...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-12T18:00:00Z","last_updated_date":"2017-12-12T18:02:00Z","reference_number":"EMA/827246/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheriatetanuspertussis-acellular-component-vaccine-adsorbed-diphtheriatetanuspertussis-acellular-component-vaccine-adsorbed-reduced-antigens-contentslist-nationally-authorised-medicinal-pr_en.pdf"},
    {"id":"10072","name":"Public statement on Enzepi: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-07-28T13:52:00Z","last_updated_date":"2017-07-28T13:52:00Z","reference_number":"EMA/473867/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-enzepi-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"10087","name":"CHMP summary of positive opinion for Telmisartan Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/CHMP/267262/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-telmisartan-teva_en.pdf"},
    {"id":"10090","name":"Boosting drug development through public-private partnerships: The Innovative Medicines Initiative model (H. Laverty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/boosting-drug-development-through-public-private-partnerships-innovative-medicines-initiative-model-h-laverty_en.pdf"},
    {"id":"10092","name":"Doxyprex 100mg Premix - Article 33 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-16T00:59:00Z","last_updated_date":"2007-11-16T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/doxyprex-100mg-premix-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"10094","name":"Calcium hypophosphite and other calcium salts: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-15T02:00:00Z","last_updated_date":"1996-05-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/calcium-hypophosphite-and-other-calcium-salts-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10098","name":"European Medicines Agency recommends cautious use of Protopic/Protopy and Elidel","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-27T02:00:00Z","last_updated_date":"2006-03-27T02:00:00Z","reference_number":"EMEA/98882/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-cautious-use-protopicprotopy-and-elidel_en.pdf"},
    {"id":"10099","name":"Medical literature monitoring service quarterly report August – October 2015","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-11-11T10:30:00Z","last_updated_date":"2015-11-11T10:30:00Z","reference_number":"EMA/741623/2015","document_url":"https://www.ema.europa.eu/en/documents/report/medical-literature-monitoring-service-quarterly-report-august-october-2015_en.pdf"},
    {"id":"10101","name":"Presentation - How scientific advice procedures can support innovation - European Medicines Agency veterinary medicines innovation day (Rory Breathnach)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-scientific-advice-procedures-can-support-innovation-european-medicines-agency-veterinary-medicines-innovation-day-rory-breathnach_en.pdf"},
    {"id":"10109","name":"European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/706409/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_en.pdf"},
    {"id":"10110","name":"Rosmarini aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/290/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/rosmarini-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10111","name":"Presentation -  CMC aspects of gene therapy medicinal products (Matthias Renner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-27T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cmc-aspects-gene-therapy-medicinal-products-matthias-renner_en.pdf"},
    {"id":"10112","name":"EU/3/10/760: Public summary of opinion on orphan designation of (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-11T01:31:00Z","last_updated_date":"2013-03-12T11:00:00Z","reference_number":"EMA/COMP/325300/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310760-public-summary-opinion-orphan-designation-3s-3-4-7-aminocarbonyl-2h-indazol-2-yl-phenyl-piperidine-tosylate-monohydrate-salt-treatment-ovarian-cancer_en.pdf"},
    {"id":"10114","name":"Day 180 list of outstanding issues generics template rev. 10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T12:15:00Z","reference_number":"Rev. 10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-180-list-outstanding-issues-generics-template-rev-1016_en.doc"},
    {"id":"10115","name":"Ambroxol and bromhexine Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T14:00:00Z","last_updated_date":"2014-04-11T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-notification_en.pdf"},
    {"id":"10116","name":"EU/3/08/576: Public summary of positive opinion for orphan designation ofcarglumic acid for the treatment of methylmalonic acidaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2021-06-09T15:05:00Z","reference_number":"EMEA/COMP/481269/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308576-public-summary-positive-opinion-orphan-designation-ofcarglumic-acid-treatment-methylmalonic-acidaemia_en.pdf"},
    {"id":"10117","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 28-29 September 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-10-12T18:40:00Z","last_updated_date":"2015-10-12T18:40:00Z","reference_number":"EMA/HMPC/657448/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-28-29-september-2015_en.pdf"},
    {"id":"10119","name":"PRAC recommends that the marketing authorisation of the painkiller flupirtine be withdrawn","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T01:00:00Z","last_updated_date":"2018-02-09T01:00:00Z","reference_number":"EMA/66114/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-recommends-marketing-authorisation-painkiller-flupirtine-be-withdrawn_en.pdf"},
    {"id":"10123","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-10-27T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"EMA/654451/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations_en.pdf-0"},
    {"id":"10125","name":"CHMP summary of positive opinion for Bavencio","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T14:00:00Z","last_updated_date":"2017-07-21T14:00:00Z","reference_number":"EMA/CHMP/426201/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bavencio_en.pdf"},
    {"id":"10126","name":"EU/3/11/867: Public summary of opinion on orphan designation: Allogeneic umbilical cord blood cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-30T02:00:00Z","last_updated_date":"2019-08-30T15:00:00Z","reference_number":"EMA/COMP/156244/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311867-public-summary-opinion-orphan-designation-allogeneic-umbilical-cord-blood-cells-treated-ex-vivo-1616-dimethyl-prostaglandin-e2-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"10127","name":"CVMP post-authorisation summary of positive opinion for Draxxin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/CVMP/233183/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-draxxin_en.pdf"},
    {"id":"10128","name":"SIAMED 2000: speeding up drug regulation in Europe","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-01-18T00:09:21Z","last_updated_date":"2001-01-18T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/siamed-2000-speeding-drug-regulation-europe_en.pdf"},
    {"id":"10129","name":"CVMP post-authorisation summary of positive opinion for BTVPUR AlSap 1-8","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-19T01:00:00Z","last_updated_date":"2016-02-19T01:00:00Z","reference_number":"EMEA/CVMP/66986/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-btvpur-alsap-1-8_en.pdf"},
    {"id":"10133","name":"Session 2 - Non-Clinical Issues - Innovator Industry Presentation - Danuta Herzyk","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-2-non-clinical-issues-innovator-industry-presentation-danuta-herzyk_en.pdf"},
    {"id":"10134","name":"Questions and answers relating to open tender procedure –EMA/2013/23/FI – High-level business consultancy services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-13T13:20:00Z","last_updated_date":"2013-10-14T18:55:00Z","reference_number":"EMA/412192/2013","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-open-tender-procedure-ema201323fi-high-level-business-consultancy-services_en.pdf"},
    {"id":"10135","name":"Updated Annexes to the HMPC status report on the implementation of the provisions of Chapter 2a of Directive 2001/83/EC as amended by Directive 2004/24/EC as regards traditional herbal medicinal products (EMEA/HMPC/18721...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-08-15T02:00:00Z","last_updated_date":"2007-08-15T02:00:00Z","reference_number":"EMEA/HMPC/369288/2007","document_url":"https://www.ema.europa.eu/en/documents/other/updated-annexes-hmpc-status-report-implementation-provisions-chapter-2a-directive-200183ec-amended-directive-200424ec-regards-traditional-herbal-medicinal-products-emeahmpc18721_en.pdf"},
    {"id":"10138","name":"Agenda - PRAC draft agenda of meeting 10-13 June 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-06-10T20:00:00Z","last_updated_date":"2013-06-10T20:00:00Z","reference_number":"EMA/PRAC/352733/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-10-13-june-2013_en.pdf"},
    {"id":"10140","name":"Public summary of positive opinion for orphan designation of deoxyribose phosphorothioate (5’-tct-ccc-agc-gtg-cgc-cat-3’) for the treatment of  multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2013-04-09T02:00:00Z","reference_number":"EMA/COMP/11100/2003 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-positive-opinion-orphan-designation-deoxyribose-phosphorothioate-5-tct-ccc-agc-gtg-cgc-cat-3-treatment-multiple-myeloma_en.pdf"},
    {"id":"10144","name":"Presentation - International workshop on the ethical and good-clinical-practice aspects of clinical trials conducted in third countries","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-17T18:34:04Z","last_updated_date":"2011-05-17T18:34:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-workshop-ethical-and-good-clinical-practice-aspects-clinical-trials-conducted-third-countries_en.pdf"},
    {"id":"10145","name":"Guideline on the Core SPC for human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/282/00)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-07-25T02:00:00Z","last_updated_date":"2002-07-25T02:00:00Z","reference_number":"CPMP/BPWG/282/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-normal-immunoglobulin-subcutaneous-and-intramuscular-use-cpmpbpwg28200_en.pdf"},
    {"id":"10146","name":"EU/3/13/1194: Public summary of opinion on orphan designation:\n\nNaproxcinod for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2018-01-23T01:00:00Z","reference_number":"EMA/COMP/553063/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131194-public-summary-opinion-orphan-designation-naproxcinod-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"10148","name":"Annex VII - Draft concession contract (EMA/2016/43/RS)","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:30:00Z","last_updated_date":"2016-08-15T12:30:00Z","reference_number":"EMA/2016/43/RS","document_url":"https://www.ema.europa.eu/en/documents/procurement/annex-vii-draft-concession-contract-ema201643rs_en.pdf"},
    {"id":"10152","name":"Presentation - Subgroup analyses in confirmatory trials – European Federation of Pharmaceutical Industries and Associations (EFPIA) perspectives (Albert Radlmaier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subgroup-analyses-confirmatory-trials-european-federation-pharmaceutical-industries-and-associations-efpia-perspectives-albert-radlmaier_en.pdf"},
    {"id":"10154","name":"Tetrabenazine:List of nationally authorised medicinal products-PSUSA/00002911/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-21T12:30:00Z","last_updated_date":"2016-10-19T12:44:32Z","reference_number":"EMA/423939/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/tetrabenazinelist-nationally-authorised-medicinal-products-psusa00002911201510_en.pdf"},
    {"id":"10155","name":"Presentation - Access to EudraVigilance data – demonstration","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-08-14T14:00:00Z","last_updated_date":"2012-08-14T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-access-eudravigilance-data-demonstration_en.pdf"},
    {"id":"10156","name":"Questions and answers on the safety of Protelos/Osseor (strontium ranelate)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-11-16T00:09:21Z","last_updated_date":"2007-11-16T00:09:21Z","reference_number":"EMEA/534613/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-safety-protelososseor-strontium-ranelate_en.pdf"},
    {"id":"10161","name":"Presentation - Session 2.1: Clinical issues: Could we accept non-inferiority instead of equivalence trials in specific situations?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:52Z","last_updated_date":"2012-06-15T17:10:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-21-clinical-issues-could-we-accept-non-inferiority-instead-equivalence-trials-specific-situations_en.pdf"},
    {"id":"10164","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 20-21 November 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-12-18T13:08:00Z","last_updated_date":"2017-12-18T13:08:00Z","reference_number":"EMA/HMPC/784341/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-20-21-november-2017_en.pdf"},
    {"id":"10165","name":"Eighth pandemic pharmacovigilance weekly update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-01-27T01:00:00Z","last_updated_date":"2010-01-27T01:00:00Z","reference_number":"EMA/55806/2010","document_url":"https://www.ema.europa.eu/en/documents/report/eighth-pandemic-pharmacovigilance-weekly-update_en.pdf"},
    {"id":"10166","name":"Rabeprazole: List of nationally authorised medicinal products - PSUSA/00002601/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-14T12:00:00Z","last_updated_date":"2016-10-17T19:46:19Z","reference_number":"EMA/413334/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabeprazole-list-nationally-authorised-medicinal-products-psusa00002601201510_en.pdf"},
    {"id":"10168","name":"Public summary of negative opinion for orphan designation\n\nof 4-[[[4-(4-Chlorophenoxy)phenyl]sulfonyl]-methyl]tetrahydro-\n\nN-hydroxy-2H-pyran-4-carboxamide for prevention of graft rejection after liver transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/67000/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-4-4-4-chlorophenoxyphenylsulfonyl-methyltetrahydro-n-hydroxy-2h-pyran-4-carboxamide-prevention-graft-rejection-after-liver-transplantation_en.pdf"},
    {"id":"10169","name":"CVMP post-authorisation summary of positive opinion for Cerenia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-19T18:00:00Z","last_updated_date":"2013-07-19T18:00:00Z","reference_number":"EMA/CVMP/322884/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-cerenia_en.pdf"},
    {"id":"10170","name":"Agenda - CAT agenda of the 6-8 September 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-09-07T20:00:00Z","last_updated_date":"2017-09-07T20:00:00Z","reference_number":"EMA/CAT/599328/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-6-8-september-2017-meeting_en.pdf"},
    {"id":"10171","name":"Questions and answers relating to tender EMEA/2009/54/IT/PM","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-11-12T01:00:00Z","last_updated_date":"2009-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-tender-emea200954itpm_en.pdf"},
    {"id":"10172","name":"Minor uses and minor species (MUMS)/limited market scheme for veterinary medicinal products - 2nd annual report (2010-2011)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-10-07T16:00:00Z","last_updated_date":"2011-10-07T16:00:00Z","reference_number":"EMA/680110/2011","document_url":"https://www.ema.europa.eu/en/documents/other/minor-uses-and-minor-species-mumslimited-market-scheme-veterinary-medicinal-products-2nd-annual-report-2010-2011_en.pdf"},
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    {"id":"10174","name":"Isoxsuprine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-09-01T02:00:00Z","last_updated_date":"1996-09-01T02:00:00Z","reference_number":"EMEA/MRL/123/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/isoxsuprine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10178","name":"Iffeza - Article 29 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T02:00:00Z","last_updated_date":"2012-10-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/iffeza-article-29-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/iffeza-article-29-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/iffeza-article-29-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/iffeza-article-29-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/iffeza-article-29-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/iffeza-article-29-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/iffeza-article-29-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/iffeza-article-29-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/iffeza-article-29-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/iffeza-article-29-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/iffeza-article-29-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/iffeza-article-29-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/iffeza-article-29-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/iffeza-article-29-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/iffeza-article-29-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/iffeza-article-29-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/iffeza-article-29-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/iffeza-article-29-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/iffeza-article-29-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/iffeza-article-29-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/iffeza-article-29-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/iffeza-article-29-referral-annex-ii_sv.pdf"}},
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    {"id":"10181","name":"Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (superseded)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-07-30T14:00:00Z","last_updated_date":"2013-07-30T14:00:00Z","reference_number":"EMA/755938/2012","document_url":"https://www.ema.europa.eu/en/documents/report/use-colistin-products-animals-within-european-union-development-resistance-and-possible-impact-human-and-animal-health-superseded_en.pdf"},
    {"id":"10183","name":"CHMP summary of positive opinion for Dinutuximab beta Apeiron","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"EMA/CHMP/153871/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dinutuximab-beta-apeiron_en.pdf"},
    {"id":"10185","name":"Presentation: OKIDS activity update, learnings and improvements","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-okids-activity-update-learnings-and-improvements_en.pdf"},
    {"id":"10186","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 on quality risk management - Step 5 - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-01-19T01:00:00Z","last_updated_date":"2014-05-28T17:30:00Z","reference_number":"EMA/CHMP/ICH/24235/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-quality-risk-management-step-5-first-version_en.pdf"},
    {"id":"10188","name":"CHMP post-authorisation summary of positive opinion for Xiapex","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-12-19T01:00:00Z","last_updated_date":"2020-03-02T01:00:00Z","reference_number":"EMA/CHMP/747440/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xiapex_en.pdf"},
    {"id":"10189","name":"Presentation - We are here for our fellow patients (E. Deschamps)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T17:06:00Z","last_updated_date":"2017-12-11T17:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-we-are-here-our-fellow-patients-e-deschamps_en.pdf"},
    {"id":"10190","name":"EU/3/11/861: Public summary of opinion on orphan designation: 9-cis-Retinyl acetate for the treatment of Leber’s congenital amauro","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2012-01-04T01:00:00Z","reference_number":"EMA/COMP/171945/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311861-public-summary-opinion-orphan-designation-9-cis-retinyl-acetate-treatment-lebers-congenital-amauro_en.pdf"},
    {"id":"10192","name":"Draft community herbal monograph on Peumus boldus Molina, folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2008-05-08T02:09:21Z","reference_number":"EMEA/HMPC/591648/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-peumus-boldus-molina-folium_en.pdf"},
    {"id":"10193","name":"Presentation - Novel and innovative nanotechnology-based delivery systems, Alexander Kabanov, University of Nebraska Medical Center","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-novel-and-innovative-nanotechnology-based-delivery-systems-alexander-kabanov-university-nebraska-medical-center_en.pdf"},
    {"id":"10194","name":"Short-acting beta-agonists Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-07T01:00:00Z","last_updated_date":"2013-11-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/short-acting-beta-agonists-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"10195","name":"CVMP post-authorisation summary of positive opinion for Panacur AquaSol (II/0015)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-01-19T01:00:00Z","last_updated_date":"2018-01-19T01:00:00Z","reference_number":"EMA/CVMP/834159/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-panacur-aquasol-ii0015_en.pdf"},
    {"id":"10197","name":"European Medicines Agency announces start of process improvement of core business procedures","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-03-18T14:57:32Z","last_updated_date":"2011-03-18T14:57:32Z","reference_number":"EMA/201374/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-announces-start-process-improvement-core-business-procedures_en.pdf"},
    {"id":"10198","name":"Standard Operating Procedure for Checklist of mandatory input to annual management review","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2006-03-06T01:00:00Z","last_updated_date":"2006-03-06T01:00:00Z","reference_number":"EMEA/6310/2006","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-checklist-mandatory-input-annual-management-review_en.pdf"},
    {"id":"10199","name":"Qualification opinion ILSI / HESI submission of novel renal biomarkers for toxicity","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-11-26T01:00:00Z","last_updated_date":"2010-11-26T01:00:00Z","reference_number":"EMA/CHMP/SAWP/283298/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-ilsi-hesi-submission-novel-renal-biomarkers-toxicity_en.pdf"},
    {"id":"10202","name":"Presentation - Update on the IMI2 Proposal to Build a Sustainable pan-European Paediatric Clinical Trials Network (William R Treem)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T13:45:00Z","last_updated_date":"2016-10-28T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-imi2-proposal-build-sustainable-pan-european-paediatric-clinical-trials-network-william-r-treem_en.pdf"},
    {"id":"10206","name":"Presentation - General considerations from industry- Session 2 (Keith Watson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-considerations-industry-session-2-keith-watson_en.pdf"},
    {"id":"10207","name":"Agenda - European Medicines Agency/International Federation for Animal Health Europe info day 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-02-06T18:10:00Z","last_updated_date":"2014-02-06T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agencyinternational-federation-animal-health-europe-info-day-2014_en.pdf"},
    {"id":"10208","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 May 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-05-20T02:00:00Z","reference_number":"EMA/CVMP/317201/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-17-19-may-2016_en.pdf"},
    {"id":"10209","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Network of Excellence for Research in Pediatric Critical Care","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-20T13:10:00Z","last_updated_date":"2011-12-20T13:10:00Z","reference_number":"EMA/866962/2011","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-network-excellence-research-pediatric-critical-care_en.pdf"},
    {"id":"10210","name":"EU Regulatory Network - List of Participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-12-17T00:09:21Z","last_updated_date":"2008-12-17T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/eu-regulatory-network-list-participants_en.pdf"},
    {"id":"10211","name":"Presentation - Preservatives: Are they safe?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preservatives-are-they-safe_en.pdf"},
    {"id":"10212","name":"CHMP summary of positive opinion for Juluca","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2018-03-23T13:00:00Z","reference_number":"EMA/CHMP/37238/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-juluca_en.pdf"},
    {"id":"10213","name":"Hydroxyethyl starch Article-107i procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-i_en.pdf-0"},
    {"id":"10214","name":"Presentation - EGGVP","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eggvp_en.pdf"},
    {"id":"10216","name":"Actira - Article 6 (12) referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-10-13T02:08:21Z","last_updated_date":"2008-10-13T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/actira-article-6-12-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"10220","name":"Presentation - A European network of paediatric research: the contribution of regulators","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:47Z","last_updated_date":"2011-05-27T15:25:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-paediatric-research-contribution-regulators_en.pdf"},
    {"id":"10223","name":"Superseded overview of comments received on Community herbal monograph on Vitis vinifera L., folium - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/276427/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-vitis-vinifera-l-folium-first-version_en.pdf"},
    {"id":"10226","name":"EU/3/11/900: Public summary of opinion on orphan designation: 20-pentaerythritol poly (oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate for the treatment o...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/COMP/635479/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311900-public-summary-opinion-orphan-designation-20-pentaerythritol-poly-oxy-12-ethanediyl-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine-10-14-bipiperidine-1-carboxylate-treatment-o_en.pdf"},
    {"id":"10227","name":"Standard operating procedure for preparation of a European public assessment report for a human medicinal product following positive or negative opinion","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-12-05T01:00:00Z","last_updated_date":"2012-09-13T17:25:00Z","reference_number":"SOP/H/3003","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-european-public-assessment-report-human-medicinal-product-following-positive-or-negative-opinion_en.pdf"},
    {"id":"10229","name":"Presentation - e-DoI and e-CV submission: Why – Who – What – How? (Luc Van Santvliet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-21T01:00:00Z","last_updated_date":"2015-01-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-e-doi-and-e-cv-submission-why-who-what-how-luc-van-santvliet_en.pdf"},
    {"id":"10233","name":"Overview of comments received on 'Community herbal monograph on Avena sativa L., herba' (EMEA/HMPC/202966/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/225877/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-avena-sativa-l-herba-emeahmpc2029662007_en.pdf"},
    {"id":"10235","name":"Overview of Staff Regulation implementing rules signed by the Management Board Chair during the period from 16 November 2012 to 26 February 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-25T13:30:00Z","last_updated_date":"2014-03-25T13:30:00Z","reference_number":"EMA/MB/121745/2014","document_url":"https://www.ema.europa.eu/en/documents/other/overview-staff-regulation-implementing-rules-signed-management-board-chair-during-period-16-november-2012-26-february-2014_en.pdf"},
    {"id":"10237","name":"Presentation - Setting the scene: Steering Group introduction to focus group and objectives (J.  Orand and F. Ioannou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:30:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-setting-scene-steering-group-introduction-focus-group-and-objectives-j-orand-and-f-ioannou_en.pdf"},
    {"id":"10239","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Polypodium vulgare L., rhizoma","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/589447/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-polypodium-vulgare-l-rhizoma_en.pdf"},
    {"id":"10242","name":"Committee for medicinal products for human use summary of positive opinion for Cayston","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2009-06-25T02:09:21Z","reference_number":"EMEA/CHMP/391766/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-cayston_en.pdf"},
    {"id":"10243","name":"Scientific recommendation on classification of advanced therapy medicinal products: allogeneic human neural stem cells derived from foetal central nervous system","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T16:40:00Z","last_updated_date":"2018-06-27T16:40:00Z","reference_number":"EMA/276886/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-human-neural-stem-cells-derived-foetal-central-nervous-system_en.pdf"},
    {"id":"10244","name":"Final assessment report on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-08-24T17:00:00Z","last_updated_date":"2013-04-02T15:00:00Z","reference_number":"EMA/HMPC/571122/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-glycyrrhiza-glabra-l-andor-glycyrrhiza-inflata-bat-andor-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"10245","name":"Agenda - Second EMEA - EGA Info Day; Generic and Biosimilar Medicines in the Centralised Procedure - For EGA Members Only","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2008-10-03T02:09:21Z","last_updated_date":"2008-10-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-emea-ega-info-day-generic-and-biosimilar-medicines-centralised-procedure-ega-members-only_en.pdf"},
    {"id":"10246","name":"Merisone and associated names Article 29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-07-28T02:00:00Z","last_updated_date":"2015-07-28T02:00:00Z","reference_number":"EMA/445102/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/merisone-and-associated-names-article-294-referral-assessment-report_en.pdf"},
    {"id":"10247","name":"Overview of comments received on the draft Public statement on the use of herbal medicinal products containing toxic unsaturated pyrrolizidine alkaloids (PAs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-14T12:30:00Z","last_updated_date":"2013-11-14T12:30:00Z","reference_number":"EMEA/HMPC/411398/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas_en.pdf"},
    {"id":"10248","name":"Humenza: Labelling","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-26T01:00:00Z","last_updated_date":"2010-02-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/humenza-labelling_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/humenza-labelling_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/humenza-labelling_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/humenza-labelling_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/humenza-labelling_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/humenza-labelling_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/humenza-labelling_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/humenza-labelling_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/humenza-labelling_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/humenza-labelling_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/humenza-labelling_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/humenza-labelling_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/humenza-labelling_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/humenza-labelling_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/humenza-labelling_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/humenza-labelling_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/humenza-labelling_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/humenza-labelling_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/humenza-labelling_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/humenza-labelling_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/humenza-labelling_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/humenza-labelling_sv.pdf"}},
    {"id":"10250","name":"Presentation - Dose–exposure-response relationship - Break-out session 2 theme 1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-exposure-response-relationship-break-out-session-2-theme-1_en.pdf"},
    {"id":"10255","name":"EU/3/18/2020: Public summary of opinion on orphan designation: Daratumumab for the treatment of AL amyloidosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T18:30:00Z","last_updated_date":"2018-07-23T18:30:00Z","reference_number":"EMA/271688/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182020-public-summary-opinion-orphan-designation-daratumumab-treatment-al-amyloidosis_en.pdf"},
    {"id":"10258","name":"PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-03-18T01:00:00Z","reference_number":"EMA/197713/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-reviews-known-risk-pneumonia-inhaled-corticosteroids-chronic-obstructive-pulmonary-disease_en.pdf"},
    {"id":"10259","name":"Standard operating procedure for organisation and management of ENCePP plenary meetings","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"SOP/H/3358","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-organisation-and-management-encepp-plenary-meetings_en.pdf"},
    {"id":"10260","name":"Presentation - Practical aspects of working electronically in the network: Croatian experience (Dubravka Sudić)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-practical-aspects-working-electronically-network-croatian-experience-dubravka-sudia_en.pdf"},
    {"id":"10262","name":"Centralised Procedure EFPIA Analysis of Performance Indicators New Applications 2005-2006 - Edwin Ruighaver","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/centralised-procedure-efpia-analysis-performance-indicators-new-applications-2005-2006-edwin-ruighaver_en.pdf"},
    {"id":"10266","name":"Overview of comments received on 'guideline on quality of oral modified-release products'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-31T17:00:00Z","last_updated_date":"2014-07-31T17:00:00Z","reference_number":"EMA/CHMP/QWP/428694/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-quality-oral-modified-release-products_en.pdf"},
    {"id":"10267","name":"Presentation - Agenda point 4: ESVAC guidance on species data – State of play (Claire Chauvin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-point-4-esvac-guidance-species-data-state-play-claire-chauvin_en.pdf"},
    {"id":"10268","name":"Presentation - RMP template (Caroline Voltz-Girolt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T16:00:00Z","last_updated_date":"2015-06-25T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rmp-template-caroline-voltz-girolt_en.pdf"},
    {"id":"10269","name":"Technical specification - Annex 7 Lot 2 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-7-lot-2-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"10270","name":"Oxfendazole: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-06-01T02:00:00Z","last_updated_date":"1997-06-01T02:00:00Z","reference_number":"EMEA/MRL/194/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxfendazole-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10271","name":"Presentation - Paediatric regulation: an update on submissions of paediatric investigation plans","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-regulation-update-submissions-paediatric-investigation-plans_en.pdf"},
    {"id":"10274","name":"Quality by Design - Application and perspectives for biologicals - Evdokia Korakianiti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/quality-design-application-and-perspectives-biologicals-evdokia-korakianiti_en.pdf"},
    {"id":"10277","name":"Presentation - How are medicines evaluated at the EMA (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-are-medicines-evaluated-ema-nathalie-bere_en.pdf-0"},
    {"id":"10280","name":"Note for guidance on the quality of modified release dosage forms for veterinary use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-07-01T02:00:00Z","last_updated_date":"2003-07-01T02:00:00Z","reference_number":"EMEA/CVMP/680/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-quality-modified-release-dosage-forms-veterinary-use_en.pdf"},
    {"id":"10281","name":"Agenda - CAT agenda of the 18-19 February 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-02-22T15:20:00Z","last_updated_date":"2016-02-22T15:20:00Z","reference_number":"EMA/CAT/82731/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-18-19-february-2016-meeting_en.pdf"},
    {"id":"10282","name":"European Medicines Agency confirms positive benefit-risk balance of topical formulations of ketoprofen","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/CHMP/465633/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-confirms-positive-benefit-risk-balance-topical-formulations-ketoprofen_en.pdf"},
    {"id":"10284","name":"EU/3/17/1952: Public summary of opinion on orphan designation: Modified messenger ribonucleic acid encoding human argininosuccinate lyase enzyme encapsulated into lipid nanoparticles for the treatment of argininosuccinic...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-23T14:42:00Z","last_updated_date":"2018-01-23T14:42:00Z","reference_number":"EMA/750696/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171952-public-summary-opinion-orphan-designation-modified-messenger-ribonucleic-acid-encoding-human-argininosuccinate-lyase-enzyme-encapsulated-lipid-nanoparticles-treatment-argininosuccinic_en.pdf"},
    {"id":"10285","name":"EU/3/15/1507: Public summary of opinion on orphan designation: 3-{[2,3,5,6-tetrafluoro-3'-(trifluoromethoxy)biphenyl-4-yl]carbamoyl}thiophene-2-carboxylic acid for the treatment of non-infectious uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"EMA/COMP/348507/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151507-public-summary-opinion-orphan-designation-3-2356-tetrafluoro-3-trifluoromethoxybiphenyl-4-ylcarbamoylthiophene-2-carboxylic-acid-treatment-non-infectious-uveitis_en.pdf"},
    {"id":"10286","name":"Viani Evohaler- Article 6 (13) referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-09-14T02:08:21Z","last_updated_date":"2007-09-14T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/viani-evohaler-article-6-13-referral-annex-i-ii-iii_fi.pdf"}},
    {"id":"10287","name":"Questions and answers on the refusal of the marketing authorisation for Glybera - Outcome of re-examination","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-10-21T02:00:00Z","last_updated_date":"2011-10-21T02:00:00Z","reference_number":"EMA/CHMP/474562/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-glybera-outcome-re-examination_en.pdf"},
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    {"id":"10295","name":"Agenda - Public hearing: Valproate","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-09-22T14:30:00Z","last_updated_date":"2017-09-25T19:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-public-hearing-valproate_en.pdf"},
    {"id":"10296","name":"Final assessment report on Plantago ovata Forssk., seminis tegumentum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T16:00:00Z","last_updated_date":"2013-07-23T16:00:00Z","reference_number":"EMA/HMPC/199775/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-plantago-ovata-forssk-seminis-tegumentum_en.pdf"},
    {"id":"10297","name":"Fifteenth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-10-03T02:00:00Z","last_updated_date":"1997-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/fifteenth-meeting-management-board_en.pdf"},
    {"id":"10298","name":"Agenda - CAT agenda of the 22-23 March 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-03-23T16:40:00Z","last_updated_date":"2016-03-23T16:40:00Z","reference_number":"EMA/CAT/164275/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-22-23-march-2016-meeting_en.pdf"},
    {"id":"10300","name":"Draft assessment report on Capsella bursa-pastoris (L.) Medikus, herba - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-01-18T01:00:00Z","last_updated_date":"2011-01-18T01:00:00Z","reference_number":"EMA/HMPC/262767/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-capsella-bursa-pastoris-l-medikus-herba-first-version_en.pdf"},
    {"id":"10303","name":"Overview of comments received on draft guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk - Revision 1","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-11-15T01:00:00Z","last_updated_date":"2007-11-15T01:00:00Z","reference_number":"EMEA/519459/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-prophylaxis-high-intra-and-post-operative-venous-thromboembolic-risk-revision-1_en.pdf"},
    {"id":"10304","name":"EU/3/16/1668: Public summary of opinion on orphan designation: Sodium nitrite and ethylenediaminetetraacetic acid for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-22T02:00:00Z","last_updated_date":"2016-06-22T02:00:00Z","reference_number":"EMA/COMP/307213/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161668-public-summary-opinion-orphan-designation-sodium-nitrite-and-ethylenediaminetetraacetic-acid-treatment-cystic-fibrosis_en.pdf"},
    {"id":"10305","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-05-22T10:25:00Z","last_updated_date":"2012-05-22T10:25:00Z","reference_number":"EMA/CVMP/299052/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-may-2012_en.pdf"},
    {"id":"10307","name":"CHMP summary of positive opinion for Isentress (X-59)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T18:35:00Z","last_updated_date":"2017-05-19T18:35:00Z","reference_number":"EMA/301751/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-summary-positive-opinion-isentress-x-59_en.pdf"},
    {"id":"10309","name":"EU/3/08/574: Public summary of positive opinion for orphan designation of autologous urothelial and smooth muscle cells for the treatment of spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2012-05-24T13:54:00Z","reference_number":"EMEA/COMP/480031/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308574-public-summary-positive-opinion-orphan-designation-autologous-urothelial-and-smooth-muscle-cells-treatment-spinal-cord-injury_en.pdf"},
    {"id":"10310","name":"Codeine Article-31 referral - Codeine not to be used in children below 12 years for cough and cold","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T02:00:00Z","last_updated_date":"2015-04-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-codeine-not-be-used-children-below-12-years-cough-and-cold_sv.pdf"}},
    {"id":"10314","name":"Guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-03-22T00:09:21Z","last_updated_date":"2007-03-22T00:09:21Z","reference_number":"EMEA/CPMP/555/95 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-trials-haemopoietic-growth-factors-prophylaxis-infection-following-myelosuppressive-or-myeloablative-therapy_en.pdf"},
    {"id":"10315","name":"EU/3/14/1292: Public summary of opinion on orphan designation: Carboxy pyrrolidine hexanoyl pyrrolidine carboxylate for the treatment of AL amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T02:00:00Z","last_updated_date":"2019-07-09T12:00:00Z","reference_number":"EMA/COMP/360624/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141292-public-summary-opinion-orphan-designation-carboxy-pyrrolidine-hexanoyl-pyrrolidine-carboxylate-treatment-al-amyloidosis_en.pdf"},
    {"id":"10316","name":"EU/3/16/1702: Public summary of opinion on orphan designation: Recombinant human monoclonal antibody to insulin receptor for the treatment of congenital hyperinsulinism","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/447608/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161702-public-summary-opinion-orphan-designation-recombinant-human-monoclonal-antibody-insulin-receptor-treatment-congenital-hyperinsulinism_en.pdf"},
    {"id":"10317","name":"Presentation - The cluster medicine approach","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cluster-medicine-approach_en.pdf"},
    {"id":"10320","name":"EMEA Performance Indicators - Extensions of indications  - Manuel Haas","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-performance-indicators-extensions-indications-manuel-haas_en.pdf"},
    {"id":"10321","name":"Presentation - Industry view (Britta Paschen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T01:00:00Z","last_updated_date":"2013-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-view-britta-paschen_en.pdf"},
    {"id":"10323","name":"Annexes to the annual report of the European Medicines Agency 2012","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2013-04-16T17:59:00Z","last_updated_date":"2013-04-16T17:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annexes-annual-report-european-medicines-agency-2012_en.pdf"},
    {"id":"10325","name":"Registration form - EMEA workshop - Medicines for bees - What the EMEA can do to increase availability","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-10-16T02:09:21Z","last_updated_date":"2009-10-16T02:09:21Z","reference_number":"EMEA/627827/2009","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-emea-workshop-medicines-bees-what-emea-can-do-increase-availability_en.pdf"},
    {"id":"10328","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): GVP annex I – Definitions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T19:18:15Z","last_updated_date":"2012-06-25T19:18:15Z","reference_number":"EMA/428732/2012","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-annex-i-definitions_en.pdf"},
    {"id":"10330","name":"Mutual recognition agreements EC - Switzerland: Questions and answers covering interpretation of Chapter 15, explanatory notes, Annex 16 and notice to applicants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2002-12-18T01:00:00Z","last_updated_date":"2002-12-18T01:00:00Z","reference_number":"EMEA/MRA/CH/84/02/Final","document_url":"https://www.ema.europa.eu/en/documents/other/mutual-recognition-agreements-ec-switzerland-questions-and-answers-covering-interpretation-chapter-15-explanatory-notes-annex-16-and-notice-applicants_en.pdf"},
    {"id":"10331","name":"List of participants - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension (PAH)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-08T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"EMA/356444/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-emafdahealth-canada-workshop-paediatric-pulmonary-arterial-hypertension-pah_en.pdf"},
    {"id":"10334","name":"Presentation - Transitional arrangements","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T13:00:00Z","last_updated_date":"2012-02-29T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-transitional-arrangements_en.pdf"},
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    {"id":"10411","name":"Spiramycin (Extension to pigs): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-06-01T02:00:00Z","last_updated_date":"1999-06-01T02:00:00Z","reference_number":"EMEA/MRL/618/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spiramycin-extension-pigs-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10412","name":"Diethylene glycol monoethyl ether (All food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-10-15T12:20:00Z","last_updated_date":"2015-10-15T12:20:00Z","reference_number":"EMA/CVMP/36933/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diethylene-glycol-monoethyl-ether-all-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"10413","name":"Committee for medicinal products for veterinary use summary of opinion: Porcilis PCV","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-11-14T01:09:21Z","last_updated_date":"2008-11-14T01:09:21Z","reference_number":"EMEA/CVMP/573498/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-porcilis-pcv_en.pdf"},
    {"id":"10414","name":"Presentation - Pharmacovigilance: Latest developments - industry perspective (Yvonne Hausmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-latest-developments-industry-perspective-yvonne-hausmann_en.pdf"},
    {"id":"10415","name":"Presentation -  The Salford Lung Study (Ashley Woodcock and David Leather)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-salford-lung-study-ashley-woodcock-and-david-leather_en.pdf"},
    {"id":"10417","name":"The voluntary harmonisation procedure (VHP) for the assessment of multinational clinical trial applications, Dr Hartmut Krafft","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/voluntary-harmonisation-procedure-vhp-assessment-multinational-clinical-trial-applications-dr-hartmut-krafft_en.pdf"},
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    {"id":"10424","name":"GVK Biosciences Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T02:00:00Z","last_updated_date":"2015-08-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gvk-biosciences-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gvk-biosciences-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gvk-biosciences-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gvk-biosciences-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gvk-biosciences-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gvk-biosciences-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gvk-biosciences-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gvk-biosciences-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gvk-biosciences-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gvk-biosciences-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gvk-biosciences-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gvk-biosciences-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gvk-biosciences-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gvk-biosciences-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gvk-biosciences-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gvk-biosciences-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gvk-biosciences-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gvk-biosciences-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gvk-biosciences-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gvk-biosciences-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gvk-biosciences-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gvk-biosciences-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"10426","name":"Committee for Advanced Therapies (CAT): December 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T09:51:00Z","last_updated_date":"2011-12-19T09:51:00Z","reference_number":"EMA/CAT/972719/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-december-2011-meeting-monthly-report_en.pdf"},
    {"id":"10428","name":"Assessment of the paediatric needs - Chemotherapy products (part II)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-06-02T02:00:00Z","last_updated_date":"2006-06-02T02:00:00Z","reference_number":"EMEA/224696/2006","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-chemotherapy-products-part-ii_en.pdf"},
    {"id":"10429","name":"Superseded overview of comments received on 'Community herbal monograph on Mentha x piperita L., aetheroleum' (EMEA/HMPC/349466/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/494410/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-mentha-x-piperita-l-aetheroleum-emeahmpc3494662006_en.pdf"},
    {"id":"10430","name":"Agenda and registration form - EudraVigilance Information Day(London, November 2016)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-09-26T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-information-daylondon-november-2016_en.pdf"},
    {"id":"10431","name":"European Medicines Agency holds first meeting of the Pharmacovigilance Risk Assessment Committee (PRAC)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-07-19T12:10:02Z","last_updated_date":"2012-07-19T12:10:02Z","reference_number":"EMA/487397/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-holds-first-meeting-pharmacovigilance-risk-assessment-committee-prac_en.pdf"},
    {"id":"10433","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 March 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-03-17T16:00:01Z","last_updated_date":"2017-03-17T16:00:01Z","reference_number":"EMA/CVMP/147249/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-march-2017_en.pdf"},
    {"id":"10434","name":"EU/3/05/325: Public summary of positive opinion for orphan designation of mannitolum for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-28T02:00:00Z","last_updated_date":"2013-09-19T02:00:00Z","reference_number":"EMEA/COMP/318112/2005 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305325-public-summary-positive-opinion-orphan-designation-mannitolum-treatment-cystic-fibrosis_en.pdf"},
    {"id":"10435","name":"Presentation - PGEU launches The European Pharmacists’ Professional Forum (EPPF) (Jamie Wilkinson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pgeu-launches-european-pharmacists-professional-forum-eppf-jamie-wilkinson_en.pdf"},
    {"id":"10436","name":"Final public statement on Picrorhiza kurroa Royle ex Benth, radix","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2015-02-18T01:00:00Z","last_updated_date":"2015-02-18T01:00:00Z","reference_number":"EMA/HMPC/161476/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-picrorhiza-kurroa-royle-ex-benth-radix_en.pdf"},
    {"id":"10438","name":"Appendix to the note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia - Methodology of clinical trials concerning the development of depot preparations of approved medici...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-02-20T01:00:00Z","last_updated_date":"2003-02-20T01:00:00Z","reference_number":"CPMP/EWP/49/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/appendix-note-guidance-clinical-investigation-medicinal-products-treatment-schizophrenia-methodology-clinical-trials-concerning-development-depot-preparations-approved-medici_en.pdf"},
    {"id":"10439","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 25- 28 June 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2018-07-03T17:45:00Z","last_updated_date":"2018-07-03T17:45:00Z","reference_number":"EMA/CHMP/SAWP/447681/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-25-28-june-2018_en.pdf"},
    {"id":"10440","name":"Presentation - ISO IDMP implementation – small agency’s perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-18T02:00:00Z","last_updated_date":"2015-06-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-iso-idmp-implementation-small-agencys-perspective_en.pdf"},
    {"id":"10442","name":"PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T14:00:00Z","last_updated_date":"2014-04-11T14:00:00Z","reference_number":"EMA/196502/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-against-combined-use-medicines-affecting-renin-angiotensin-ras-system_en.pdf"},
    {"id":"10444","name":"Withdrawal letter: Restaysis","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-restaysis_en.pdf"},
    {"id":"10448","name":"Declaration of interest: Herlinde Herpoel","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-26T02:00:00Z","last_updated_date":"2016-09-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interest-herlinde-herpoel_en.pdf"},
    {"id":"10450","name":"Monthly Report - Pharmacovigilance Working Party (PHVWP) October 2009 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-10-29T00:00:00Z","last_updated_date":"2009-10-29T00:00:00Z","reference_number":"EMEA/666243/2009","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-october-2009-plenary-meeting_en.pdf"},
    {"id":"10452","name":"Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T14:10:01Z","last_updated_date":"2015-09-16T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course_en.pdf"},
    {"id":"10453","name":"CHMP post authorisation summary of positive opinion for  Zavesca on 18 December 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/335965/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zavesca-18-december-2008_en.pdf"},
    {"id":"10456","name":"Overview of comments received on the draft guideline on the use of statistical signal-detection methods in the EudraVigilance data-analysis system","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2017-02-07T15:41:00Z","reference_number":"EMEA/252216/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-guideline-use-statistical-signal-detection-methods-eudravigilance-data-analysis-system_en.pdf"},
    {"id":"10457","name":"New medicine for rare bone disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-12-15T01:00:00Z","last_updated_date":"2017-12-15T01:00:00Z","reference_number":"EMA/CHMP/824779/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-rare-bone-disease_en.pdf"},
    {"id":"10458","name":"Agenda and registration form - EudraVigilance training on electronic reporting of Individual Case Study Reports (ICSRs) in the European Economic Area (Vienna, Nov 2016)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-08-19T02:00:00Z","last_updated_date":"2016-08-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-study-reports-icsrs-european-economic-area-vienna-nov-2016_en.pdf"},
    {"id":"10460","name":"European Medicines Agency hosts first workshop on subgroup analysis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-24T17:00:00Z","last_updated_date":"2011-11-24T17:00:00Z","reference_number":"EMA/907825/2011 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-hosts-first-workshop-subgroup-analysis_en.pdf"},
    {"id":"10462","name":"EU/3/05/304: Public summary of positive opinion for orphan designation of imatinib mesilate for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2015-02-10T01:00:00Z","reference_number":"EMA/COMP/244140/2005 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305304-public-summary-positive-opinion-orphan-designation-imatinib-mesilate-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"10464","name":"Daunorubicin: CMDh Scientific conclusions and grounds for the variation,\n\namendments to the Product Information, and timetable\n\nfor the implementation - PSUSA/00000936/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-04T14:00:00Z","last_updated_date":"2016-10-17T20:37:52Z","reference_number":"EMA/238721/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/daunorubicin-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000936201506_en.pdf"},
    {"id":"10465","name":"Presentation - Marketing-authorisation application pre-submission issues and European Medicines Agency meeting opportunities (Irene Rager)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-marketing-authorisation-application-pre-submission-issues-and-european-medicines-agency-meeting-opportunities-irene-rager_en.pdf"},
    {"id":"10466","name":"Overview of comments received on draft guideline on the SPC for anthelmintics","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-07-12T02:09:21Z","last_updated_date":"2007-07-12T02:09:21Z","reference_number":"EMEA/CVMP/EWP/413825/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-spc-anthelmintics_en.pdf"},
    {"id":"10468","name":"Committee for Proprietary Medicinal Products (CPMP) 35th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-02-27T00:00:00Z","last_updated_date":"1998-02-27T00:00:00Z","reference_number":"CPMP/209/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-35th-plenary-meeting_en.pdf"},
    {"id":"10469","name":"Minutes of the 95th meeting of the Management Board: 16 March 2017","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-05-03T16:35:00Z","last_updated_date":"2017-05-03T16:35:00Z","reference_number":"EMA/MB/183915/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-95th-meeting-management-board-16-march-2017_en.pdf"},
    {"id":"10470","name":"Opinion of the CVMP on the establishment of maximum residue limits: Barium selenate","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-04-28T15:34:00Z","last_updated_date":"2015-04-28T15:34:00Z","reference_number":"EMA/CVMP/176966/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-barium-selenate_en.pdf"},
    {"id":"10472","name":"Agenda - PRAC draft agenda of the inaugural plenary meeting 19-20 July 2012","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2012-07-18T20:14:41Z","last_updated_date":"2012-07-18T20:14:41Z","reference_number":"EMA/PRAC/239375/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-inaugural-plenary-meeting-19-20-july-2012_en.pdf"},
    {"id":"10475","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  opgenra: International non-proprietary name (INN): eptotermin alfa","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2008-06-26T02:09:21Z","reference_number":"EMEA/308379/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-opgenra-international-non-proprietary-name-inn-eptotermin-alfa_en.pdf"},
    {"id":"10480","name":"Overview of comments received on the draft ‘Questions and Answers on Benzalkonium chloride’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/601508/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-questions-and-answers-benzalkonium-chloride_en.pdf"},
    {"id":"10481","name":"Frontotemporal Dementia: More than an exclusion diagnosis? - Alessandro Padovani","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-11T00:09:21Z","last_updated_date":"2008-02-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/frontotemporal-dementia-more-exclusion-diagnosis-alessandro-padovani_en.pdf"},
    {"id":"10482","name":"CHMP post-authorisation summary of positive opinion for Votubia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/CHMP/734936/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-votubia_en.pdf-0"},
    {"id":"10483","name":"Biologics in inflammatory disease - a novel European network for pharmacovigilance and pharmacoepidemiology - Dr. J. Askling","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/biologics-inflammatory-disease-novel-european-network-pharmacovigilance-and-pharmacoepidemiology-dr-j-askling_en.pdf"},
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    {"id":"10494","name":"Presentation - EMA SPOR master data management roadmap (Kepa Amutxastegi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-18T02:00:00Z","last_updated_date":"2015-06-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-spor-master-data-management-roadmap-kepa-amutxastegi_en.pdf"},
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    {"id":"10496","name":"Questions and answers on Zinnat and associated names (cefuroxime axetil, 125-, 250- and 500-mg tablets and 125-, 250- and 500-mg granules for oral suspension)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T14:00:00Z","last_updated_date":"2013-01-29T15:11:00Z","reference_number":"EMA/CHMP/339191/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-zinnat-and-associated-names-cefuroxime-axetil-125-250-and-500-mg-tablets-and-125-250-and-500-mg-granules-oral-suspension_sv.pdf"}},
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    {"id":"10504","name":"Presentation - Topic 6 - Conclusions and next steps - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Michael Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-6-conclusions-and-next-steps-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-michael-berntgen_en.pdf"},
    {"id":"10508","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Bone-marrow-derived autologous CD34+ cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-06-04T15:58:00Z","last_updated_date":"2012-06-04T15:58:00Z","reference_number":"EMA/349063/2012","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-bone-marrow-derived-autologous-cd34-cells_en.pdf"},
    {"id":"10509","name":"European Medicines Agency recommendations on the use of Linoladiol N and Linoladiol HN estradiol-containing creams","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/247548/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommendations-use-linoladiol-n-and-linoladiol-hn-estradiol-containing-creams_en.pdf"},
    {"id":"10510","name":"Opinion of the HMPC on a European Union herbal monograph on Echinacea purpurea (L.) Moench, radix – Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-08-11T02:00:00Z","last_updated_date":"2017-08-11T02:00:00Z","reference_number":"EMA/HMPC/319071/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-echinacea-purpurea-l-moench-radix-revision-1_en.pdf"},
    {"id":"10511","name":"Committee on herbal medicinal products (HMPC): Meeting report, 23-24 September 2004","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2004-10-01T02:00:00Z","last_updated_date":"2004-10-01T02:00:00Z","reference_number":"EMEA/HMPC/86934/2004","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-23-24-september-2004_en.pdf"},
    {"id":"10512","name":"European Medicines Agency regulatory tools for early access to medicines","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-07-27T17:00:00Z","last_updated_date":"2015-07-27T17:00:00Z","reference_number":"EMA/480969/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-regulatory-tools-early-access-medicines_en.pdf"},
    {"id":"10515","name":"Nicardipine Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-03-12T13:00:00Z","last_updated_date":"2014-03-12T13:00:00Z","reference_number":"EMA/711459/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/nicardipine-article-31-referral-assessment-report_en.pdf"},
    {"id":"10516","name":"Theophylline: List of nationally authorised medicinal products - PSUSA/00002921/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-14T15:30:00Z","last_updated_date":"2018-03-14T15:30:00Z","reference_number":"EMA/135395/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/theophylline-list-nationally-authorised-medicinal-products-psusa00002921201706_en.pdf"},
    {"id":"10517","name":"Concept paper on the development of a committee for proprietary medicinal products (CPMP) note for guidance on requirements for the evaluation of new adjuvants in vaccines","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2002-04-25T02:00:00Z","last_updated_date":"2002-04-25T02:00:00Z","reference_number":"CPMP/BWP/6622/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-proprietary-medicinal-products-cpmp-note-guidance-requirements-evaluation-new-adjuvants-vaccines_en.pdf"},
    {"id":"10518","name":"Final assessment report on Symphytum officinale L., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-06-05T02:00:00Z","last_updated_date":"2015-06-05T02:00:00Z","reference_number":"EMA/HMPC/572844/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-symphytum-officinale-l-radix_en.pdf"},
    {"id":"10522","name":"Dornase alpha: List of nationally authorised medicinal products - PSUSA/00001164/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-24T18:00:00Z","last_updated_date":"2018-05-24T18:09:00Z","reference_number":"EMA/333504/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/dornase-alpha-list-nationally-authorised-medicinal-products-psusa00001164201709_en.pdf"},
    {"id":"10524","name":"EU/3/16/1766: Public summary of positive opinion for orphan designation of venetoclax for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/623825/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161766-public-summary-positive-opinion-orphan-designation-venetoclax-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"10528","name":"Prozac- Article 6 (12) referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-09-05T02:08:21Z","last_updated_date":"2006-09-05T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/prozac-article-6-12-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"10529","name":"VICH GL55 Overview of comments: Harmonization of criteria to waive target animal batch safety testing for live vaccines for veterinary use - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-06-27T18:00:00Z","last_updated_date":"2017-06-27T18:00:00Z","reference_number":"VICH/12/056","document_url":"https://www.ema.europa.eu/en/documents/comments/vich-gl55-overview-comments-harmonization-criteria-waive-target-animal-batch-safety-testing-live-vaccines-veterinary-use-first-version_en.pdf"},
    {"id":"10531","name":"Monthly report - Pharmacovigilance Working Party (PhVWP) November 2011 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-11-24T10:30:00Z","last_updated_date":"2011-11-24T10:30:00Z","reference_number":"EMA/CHMP/PhVWP/909637/2011","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-november-2011-plenary-meeting_en.pdf"},
    {"id":"10532","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Plantago ovata Forssk., seminis tegumentum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-07-13T02:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/353208/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-plantago-ovata-forssk-seminis-tegumentum_en.pdf"},
    {"id":"10533","name":"Decision on amending budget No 2-2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-12-22T15:00:00Z","last_updated_date":"2014-12-22T15:00:00Z","reference_number":"EMA/MB/421089/2014","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-2-2014_en.pdf"},
    {"id":"10536","name":"Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-04-04T16:35:00Z","last_updated_date":"2018-06-27T17:30:00Z","reference_number":"EMA/775204/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf"},
    {"id":"10537","name":"Superseded community herbal monograph on Hypericum perforatum L., herba (traditional use)","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2009-12-21T00:09:00Z","last_updated_date":"2023-02-22T00:09:00Z","reference_number":"EMEA/HMPC/745582/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-hypericum-perforatum-l-herba-traditional-use_en.pdf"},
    {"id":"10539","name":"GVK Biosciences products for which the marketing authorisations are recommended for suspension by the CHMP on 22 January 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T13:00:00Z","last_updated_date":"2015-02-27T13:00:00Z","reference_number":"EMA/52196/2015","document_url":"https://www.ema.europa.eu/en/documents/other/gvk-biosciences-products-which-marketing-authorisations-are-recommended-suspension-chmp-22-january-2015_en.pdf"},
    {"id":"10541","name":"Ex ante publicity of a negotiated procedure: exhibition logistics","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T13:10:00Z","last_updated_date":"2016-02-05T13:10:00Z","reference_number":"EMA/70780/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-exhibition-logistics_en.pdf"},
    {"id":"10544","name":"European Medicines Agency recommends restricting use of trimetazidine-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T12:00:00Z","last_updated_date":"2012-06-22T12:00:00Z","reference_number":"EMA/CHMP/417861/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-trimetazidine-containing-medicines_en.pdf"},
    {"id":"10545","name":"Technical Specifications - Annex I Costing sheet: Procurement procedure EMA/2014/01/PH","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-i-costing-sheet-procurement-procedure-ema201401ph_en.pdf"},
    {"id":"10547","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/416862/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-human-mesenchymal-stem-cells-derived-whartons-jelly-tissue-umbilical-cord_en.pdf"},
    {"id":"10551","name":"Committee for Medicinal Products for Human Use (CHMP) - May 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-06-07T02:00:00Z","last_updated_date":"2005-06-07T02:00:00Z","reference_number":"EMEA/CHMP/160895/2005, corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-may-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"10552","name":"Overview of comments received on Community herbal monograph on Commiphora molmol Engler, gummi-resina","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T15:00:00Z","last_updated_date":"2011-12-22T15:00:00Z","reference_number":"EMA/HMPC/354015/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"10554","name":"Agenda - PRAC draft agenda of meeting 29 August-1 September 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-08-29T19:00:00Z","last_updated_date":"2017-08-29T19:00:00Z","reference_number":"EMA/PRAC/568796/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-29-august-1-september-2017_en.pdf"},
    {"id":"10555","name":"Pre-Qualification Questionnaire (PQQ) for a restricted tender procedure organised by European Medicines Agency (EMEA) catering consultant EMEA/2008/45/ISERV","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:21Z","last_updated_date":"2008-11-25T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure-organised-european-medicines-agency-emea-catering-consultant-emea200845iserv_en.doc"},
    {"id":"10557","name":"EMEA implementation of electronic-only submission and eCTD submission: Practical guidelines relating to non-eCTD electronic submissions","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-12-01T01:00:00Z","last_updated_date":"2008-12-01T01:00:00Z","reference_number":"EMEA/633919/2008 v1.0","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/emea-implementation-electronic-only-submission-and-ectd-submission-practical-guidelines-relating-non-ectd-electronic-submissions_en.pdf"},
    {"id":"10558","name":"Presentation - Clinical trial safety reporting requirements (Sophia Mylona)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T12:14:00Z","last_updated_date":"2017-03-30T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trial-safety-reporting-requirements-sophia-mylona_en.pdf"},
    {"id":"10559","name":"Superseded - Opinion of the Committee on Herbal Medicinal Products on a Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-05-16T02:00:00Z","last_updated_date":"2018-07-03T02:00:00Z","reference_number":"EMA/HMPC/756918/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizome-first-version_en.pdf"},
    {"id":"10562","name":"Final list of references supporting the assessment of Pimpinella anisum L., fructus and Pimpinella anisum L., aetheroleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-06-18T02:00:00Z","last_updated_date":"2014-06-18T02:00:00Z","reference_number":"EMEA/HMPC/321182/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-pimpinella-anisum-l-fructus-and-pimpinella-anisum-l-aetheroleum_en.pdf"},
    {"id":"10563","name":"Note for guidance for the determination of withdrawal periods for milk","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"EMEA/CVMP/473/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-determination-withdrawal-periods-milk_en.pdf"},
    {"id":"10564","name":"Presentation - Detection of toxicity to reproduction for human pharmaceuticals (G. Waxenecker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T10:54:00Z","last_updated_date":"2017-11-15T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-detection-toxicity-reproduction-human-pharmaceuticals-g-waxenecker_en.pdf"},
    {"id":"10565","name":"EU/3/16/1733 : Public summary of opinion on orphan designation: Temozolomide for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161733-public-summary-opinion-orphan-designation-temozolomide-treatment-glioma_en.pdf"},
    {"id":"10567","name":"EMEA public statement on infliximab (Remicade): Update on safety concerns","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-02-01T01:00:00Z","last_updated_date":"2002-02-01T01:00:00Z","reference_number":"CPMP/32/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-infliximab-remicade-update-safety-concerns_en.pdf"},
    {"id":"10569","name":"Press release: Committee for Orphan Medicinal Products July 2007 Meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-08-06T02:09:21Z","last_updated_date":"2007-08-06T02:09:21Z","reference_number":"EMEA/COMP/328111/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-committee-orphan-medicinal-products-july-2007-meeting_en.pdf"},
    {"id":"10570","name":"Lactose of bovine origin Article-31 referral - PRAC recommends that injectable methylprednisolone products containing lactose must not be given to patients allergic to cow's milk proteins","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-07-07T02:00:00Z","reference_number":"EMA/416655/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/lactose-bovine-origin-article-31-referral-prac-recommends-injectable-methylprednisolone-products-containing-lactose-must-not-be-given-patients-allergic-cows-milk-proteins_en.pdf"},
    {"id":"10571","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-08-19T02:00:00Z","last_updated_date":"2011-08-19T02:00:00Z","reference_number":"EMA/681354/2011","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-mesenchymal-stem-cells_en.pdf"},
    {"id":"10572","name":"CHMP post-authorisation summary of positive opinion for Revestive","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/178344/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revestive_en.pdf"},
    {"id":"10573","name":"Agenda: Veterinary pharmacovigilance question time: better regulation for electronic reporting and periodic safety update reports (PSURs)","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2010-11-11T01:00:00Z","last_updated_date":"2011-04-14T02:00:00Z","reference_number":"EMA/433980/2010-Draft","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-veterinary-pharmacovigilance-question-time-better-regulation-electronic-reporting-and-periodic-safety-update-reports-psurs_en.pdf"},
    {"id":"10575","name":"Day 150 or Day 195 joint response assessment report - Non-clinical template - Rev. 05. 21","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2006-09-01T02:09:00Z","last_updated_date":"2021-06-25T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-150-or-day-195-joint-response-assessment-report-non-clinical-template-rev-05-21_en.docx"},
    {"id":"10578","name":"Presentation - European Medicines Agency update on Clinical Data Publication (CDP) (Anne-Sophie Henry-Eude)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-update-clinical-data-publication-cdp-anne-sophie-henry-eude_en.pdf"},
    {"id":"10579","name":"Agenda - CAT agenda of the 16-17 June 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T11:50:00Z","last_updated_date":"2016-06-17T11:50:00Z","reference_number":"EMA/CAT/423125/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-17-june-2016-meeting_en.pdf"},
    {"id":"10580","name":"Guideline on requirements for Vaccine Antigen Mater File (VAMF) certification","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-02-26T01:00:00Z","last_updated_date":"2004-02-26T01:00:00Z","reference_number":"EMEA/CPMP/4548/03/Final","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-requirements-vaccine-antigen-mater-file-vamf-certification_en.pdf"},
    {"id":"10582","name":"Overview of comments received on draft guideline on similar biological medicinal products containing recombinant erythropoietins","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/38050/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-similar-biological-medicinal-products-containing-recombinant-erythropoietins_en.pdf"},
    {"id":"10584","name":"Presentation - Session III - Narcotics for sedation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-18T02:00:00Z","last_updated_date":"2016-10-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-iii-narcotics-sedation_en.pdf"},
    {"id":"10585","name":"Dorzolamide: List of nationally authorised medicinal products - PSUSA/00003168/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-22T10:30:00Z","last_updated_date":"2016-12-22T10:57:39Z","reference_number":"EMA/863720/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/dorzolamide-list-nationally-authorised-medicinal-products-psusa00003168201602_en.pdf"},
    {"id":"10586","name":"Danofloxacin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-06-25T02:00:00Z","last_updated_date":"1996-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/danofloxacin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10587","name":"Sales of veterinary antimicrobial agents in 25 European Union / European Economic Area countries in 2011 - Third European Surveillance of Veterinary Antimicrobial Consumption report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-10-15T16:35:00Z","last_updated_date":"2013-10-15T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/sales-veterinary-antimicrobial-agents-25-european-union-european-economic-area-countries-2011-third-european-surveillance-veterinary-antimicrobial-consumption-report_en.pdf"},
    {"id":"10588","name":"Presentation - The possible mechanisms of the disease, Eugene Major","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-possible-mechanisms-disease-eugene-major_en.pdf"},
    {"id":"10591","name":"Public hearing on Valproate - First experience and lessons learnt","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-08T02:00:00Z","last_updated_date":"2018-06-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/public-hearing-valproate-first-experience-and-lessons-learnt_en.pdf"},
    {"id":"10592","name":"Committee for medicinal products for veterinary use: Meeting of 14 to 16 February 2006","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-02-17T12:09:21Z","last_updated_date":"2006-02-17T12:09:21Z","reference_number":"EMEA/CVMP/43330/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-14-16-february-2006_en.pdf"},
    {"id":"10594","name":"Questions and answers on the review of centrally authorised medicines with ingredients manufactured at Roche Carolina Inc., Florence, United States","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T17:00:00Z","last_updated_date":"2012-07-20T17:00:00Z","reference_number":"EMA/476366/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-centrally-authorised-medicines-ingredients-manufactured-roche-carolina-inc-florence-united-states_en.pdf"},
    {"id":"10595","name":"Assessment Report for Diovan - EMEA/H/A/-29 PAD/1220","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"EMA/296507/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-diovan-emeaha-29-pad1220_en.pdf"},
    {"id":"10597","name":"EU/3/01/058: Public summary of positive opinion for orphan designation of repertaxin l-lysinate salt for the prevention of delayed graft function in organ transplant","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMEA/COMP/261/2004 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301058-public-summary-positive-opinion-orphan-designation-repertaxin-l-lysinate-salt-prevention-delayed-graft-function-organ-transplant_en.pdf"},
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    {"id":"10599","name":"Public statement on Enviage: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2011-05-19T02:00:00Z","last_updated_date":"2011-05-19T02:00:00Z","reference_number":"EMA/231284/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-enviage-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"10604","name":"Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the 'Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014' - Specific comments received on...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-12-03T13:30:00Z","last_updated_date":"2015-12-03T13:30:00Z","reference_number":"EMA/739151/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-ema6414792014-draft-proposal-addendum-transparency-functional-specifications-eu-portal-and-eu-database-be-audited-ema421762014-specific-comments-received_en.pdf-0"},
    {"id":"10607","name":"Ambroxol and bromhexine Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T14:00:00Z","last_updated_date":"2014-12-05T13:00:00Z","reference_number":"EMA/PRAC/189079/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"10608","name":"EU/3/18/2036: Public summary of opinion on orphan designation: L-cystine bis(N'-methylpiperazide) for the treatment of cystinuria","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T12:50:00Z","last_updated_date":"2018-08-21T12:50:00Z","reference_number":"EMA/378641/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182036-public-summary-opinion-orphan-designation-l-cystine-bisn-methylpiperazide-treatment-cystinuria_en.pdf"},
    {"id":"10609","name":"Ex ante publicity of a negotiated procedure: promotional products and  corporate gifts","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T10:35:00Z","last_updated_date":"2016-02-15T10:35:00Z","reference_number":"EMA/22900/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-promotional-products-and-corporate-gifts_en.pdf"},
    {"id":"10613","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Varicella-zoster virus (live, attenuated) for prevention of varicella-zoster-virus reactivation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T12:15:00Z","last_updated_date":"2014-12-12T12:15:00Z","reference_number":"EMA/757976/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-varicella-zoster-virus-live-attenuated-prevention-varicella-zoster-virus-reactivation_en.pdf"},
    {"id":"10615","name":"Draft list of references for assessment of: Taraxaci folium Taraxacum officinale Weber ex Wigg., folium (dandelion leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-01-14T00:09:21Z","last_updated_date":"2009-01-14T00:09:21Z","reference_number":"EMEA/HMPC/579635/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-taraxaci-folium-taraxacum-officinale-weber-ex-wigg-folium-dandelion-leaf_en.pdf"},
    {"id":"10616","name":"Monepantel (ovine and caprine; extension of provisional MRLs): European Public MRL Assessment Report (2) (EPMAR) - Committee for Medicinal Products for Veterinary Use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2011-05-16T02:00:00Z","last_updated_date":"2011-05-16T02:00:00Z","reference_number":"EMA/CVMP/306267/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/monepantel-ovine-and-caprine-extension-provisional-mrls-european-public-mrl-assessment-report-2-epmar-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"10617","name":"Scientific recommendation on classification of advanced therapy medicinal products: recombinant adeno-associated viral vector serotype 2 encoding the human aromatic L-amino acid decarboxylase gene","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-10-21T20:00:00Z","last_updated_date":"2016-10-21T20:00:00Z","reference_number":"EMA/679228/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-viral-vector-serotype-2-encoding-human-aromatic-l-amino-acid-decarboxylase-gene_en.pdf"},
    {"id":"10618","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Iclusig (ponatinib) for the treatment of acute lymphoblastic leukaemia and chronic myeloid leukaemia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2013-07-31T17:25:00Z","last_updated_date":"2013-07-31T17:25:00Z","reference_number":"EMA/238239/2013 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-iclusig-ponatinib-treatment-acute-lymphoblastic-leukaemia-and-chronic-myeloid-leukaemia_en.pdf"},
    {"id":"10620","name":"CHMP post-authorisation summary of positive opinion for Revlimid (II-89G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/CHMP/35623/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revlimid-ii-89g_en.pdf"},
    {"id":"10621","name":"Compilation of Procedures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-11-30T01:00:00Z","last_updated_date":"2010-04-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/compilation-procedures_en.zip"},
    {"id":"10623","name":"Presentation - European Medicines Agency survey on \"Centralised post-marketing authorisation procedures\" 2015 (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T02:00:00Z","last_updated_date":"2015-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-survey-centralised-post-marketing-authorisation-procedures-2015-marie-helene-pinheiro_en.pdf"},
    {"id":"10624","name":"ENCIAG Members (ENCePP Implementation Advisory Group)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-04-02T02:00:00Z","last_updated_date":"2008-04-02T02:00:00Z","reference_number":"EMEA/192773/2008","document_url":"https://www.ema.europa.eu/en/documents/other/enciag-members-encepp-implementation-advisory-group_en.pdf"},
    {"id":"10627","name":"European Medicines Agency workshop on pharmacogenomics: from science to clinical care - Invitation for expressions of interest","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T13:20:00Z","last_updated_date":"2012-05-10T17:54:00Z","reference_number":"EMA/47793/2012","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-workshop-pharmacogenomics-science-clinical-care-invitation-expressions-interest_en.pdf"},
    {"id":"10628","name":"EU/3/08/565: Public summary of positive opinion for orphan designation of drotrecogin alfa (activated) for the treatment of acute respiratory distress syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T01:00:00Z","last_updated_date":"2021-09-21T10:11:00Z","reference_number":"EMEA/COMP/441380/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308565-public-summary-positive-opinion-orphan-designation-drotrecogin-alfa-activated-treatment-acute-respiratory-distress-syndrome_en.pdf"},
    {"id":"10632","name":"Start of Community reviews - CHMP meeting of 22-25 July 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/458581/2013","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-22-25-july-2013_en.pdf"},
    {"id":"10634","name":"Annual report of the Pharmacovigilance Inspectors Working Group for 2011","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2012-07-13T02:00:00Z","last_updated_date":"2012-07-13T02:00:00Z","reference_number":"EMA/INS/PhV/193153/2012","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-pharmacovigilance-inspectors-working-group-2011_en.pdf"},
    {"id":"10635","name":"Veterinary medicines highlights 2015","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T13:00:00Z","last_updated_date":"2016-01-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/veterinary-medicines-highlights-2015_en.pdf"},
    {"id":"10636","name":"Presentation - Holistic approach to paediatric research: clinical trial facilitation group (A.M. Jason Lang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:04:00Z","last_updated_date":"2018-06-18T12:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-clinical-trial-facilitation-group-am-jason-lang_en.pdf"},
    {"id":"10638","name":"Article 107 referral - Assessment report for Octagam 5% and Octagam 10% medicinal products","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/331530/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/article-107-referral-assessment-report-octagam-5-and-octagam-10-medicinal-products_en.pdf"},
    {"id":"10639","name":"Committee for Proprietary Medicinal Products (CPMP) 62nd plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-07-31T02:00:00Z","last_updated_date":"2000-07-31T02:00:00Z","reference_number":"CPMP/1964/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-62nd-plenary-meeting_en.pdf"},
    {"id":"10640","name":"Superseded community herbal monograph on Cynara scolymus L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T01:00:00Z","last_updated_date":"2011-12-21T01:00:00Z","reference_number":"EMA/HMPC/150218/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-cynara-scolymus-l-folium_en.pdf"},
    {"id":"10641","name":"Guideline on core summary of product characteristics (SmPC)for human fibrinogen products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T10:35:00Z","last_updated_date":"2015-07-24T10:35:00Z","reference_number":"EMA/CHMP/BPWP/691754/2013 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-smpcfor-human-fibrinogen-products_en.pdf"},
    {"id":"10642","name":"Presentation - General considerations from industry - Session 4 (Andrew Lennard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-considerations-industry-session-4-andrew-lennard_en.pdf"},
    {"id":"10643","name":"CHMP post-authorisation summary of positive opinion for Bondenza","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T00:09:21Z","last_updated_date":"2013-05-13T19:00:00Z","reference_number":"EMA/821569/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-bondenza_en.pdf"},
    {"id":"10645","name":"Dinoprost tromethamine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-15T02:00:00Z","last_updated_date":"1996-05-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dinoprost-tromethamine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10646","name":"Ancillary - Day 80 Quality template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:25:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-80-quality-template-rev1016_en.doc"},
    {"id":"10647","name":"CHMP statistics: September 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-statistics-september-2015_en.pdf"},
    {"id":"10650","name":"Presentation - Update on Working Group 6 (Saul Faust, Ron Portman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-working-group-6-saul-faust-ron-portman_en.pdf"},
    {"id":"10652","name":"Organisational matters - CHMP meeting 16-19 July 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-25T14:10:00Z","last_updated_date":"2012-07-25T14:10:00Z","reference_number":"EMA/CHMP/410525/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-16-19-july-2012_en.pdf"},
    {"id":"10655","name":"CHMP post-authorisation summary of positive opinion for Tresiba","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/CHMP/164154/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tresiba_en.pdf-0"},
    {"id":"10656","name":"Terebinthinae laricina: Summary Report  – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:09:21Z","last_updated_date":"1998-04-01T02:09:21Z","reference_number":"EMEA/MRL/398/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/terebinthinae-laricina-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10657","name":"Inovelon: Questions and answers on the outcome of an extension of indication application for Inovelon (rufinamide)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2017-02-08T10:53:00Z","last_updated_date":"2017-02-08T10:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/inovelon-questions-and-answers-outcome-extension-indication-application-inovelon-rufinamide_en.pdf"},
    {"id":"10658","name":"EU/3/11/873: Public summary of opinion on orphan designation: Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2014-04-01T18:00:00Z","reference_number":"EMA/COMP/247220/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311873-public-summary-opinion-orphan-designation-human-dermal-fibroblasts-cultured-bioresorbable-polyglactin-mesh-treatment-epidermolysis-bullosa_en.pdf"},
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    {"id":"10674","name":"EU/3/16/1677: Public summary of opinion on orphan designation: Diclofenamide for the treatment of periodic paralysis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/393522/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161677-public-summary-opinion-orphan-designation-diclofenamide-treatment-periodic-paralysis_en.pdf"},
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    {"id":"10677","name":"EU/3/13/1135: Public summary of opinion on orphan designation: Recombinant human nerve growth factor for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2015-05-13T19:00:00Z","reference_number":"EMA/COMP/272347/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131135-public-summary-opinion-orphan-designation-recombinant-human-nerve-growth-factor-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"10678","name":"Standard Operating Procedure for handling of a request for accelerated assessment of initial marketing authorisation applications (human use)","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2009-01-05T01:00:00Z","last_updated_date":"2009-01-05T01:00:00Z","reference_number":"SOP/H/3182","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-handling-request-accelerated-assessment-initial-marketing-authorisation-applications-human-use_en.pdf"},
    {"id":"10680","name":"HPV vaccines Article-20 procedure - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-11-26T13:00:00Z","last_updated_date":"2015-11-26T13:00:00Z","reference_number":"EMA/762033/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/hpv-vaccines-article-20-procedure-assessment-report_en.pdf"},
    {"id":"10681","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module IV – Pharmacovigilance audits","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-13T17:00:00Z","last_updated_date":"2012-12-13T17:00:00Z","reference_number":"EMA/806364/2012","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-module-iv-pharmacovigilance-audits_en.pdf"},
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    {"id":"10685","name":"Final European Union herbal monograph on Glycine max (L.) Merr., lecithinum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-11-20T01:00:00Z","last_updated_date":"2017-11-20T01:00:00Z","reference_number":"EMA/HMPC/220599/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-glycine-max-l-merr-lecithinum_en.pdf"},
    {"id":"10687","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Vyndaqel (N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) for treatment ...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T11:30:00Z","last_updated_date":"2021-11-25T11:30:00Z","reference_number":"EMA/COMP/729178/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-vyndaqel-n-methyl-d-23456-pentahydroxy-hexyl-ammonium-2-35-dichloro-phenyl-benzoxazole-6-carboxylate-treatment_en.pdf"},
    {"id":"10689","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Clostridium difficile toxin B human monoclonal antibody for treatment of Clostridium difficile infection","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T12:30:00Z","last_updated_date":"2015-02-23T12:30:00Z","reference_number":"EMA/715190/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-clostridium-difficile-toxin-b-human-monoclonal-antibody-treatment-clostridium-difficile-infection_en.pdf"},
    {"id":"10690","name":"Cinchonae cortex: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/711/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cinchonae-cortex-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10692","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 14-16 September 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-10-04T17:20:00Z","last_updated_date":"2016-10-04T17:20:00Z","reference_number":"EMA/PDCO/616910/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-14-16-september-2016_en.pdf"},
    {"id":"10695","name":"Second report on the progress on the interaction between EMEA\n\nand patients’ and consumers’ organisations (including performance\n\nindicators)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-10-01T02:09:21Z","last_updated_date":"2009-10-01T02:09:21Z","reference_number":"EMEA/MB/576691/2009","document_url":"https://www.ema.europa.eu/en/documents/report/second-report-progress-interaction-between-emea-and-patients-and-consumers-organisations-including-performance-indicators_en.pdf"},
    {"id":"10696","name":"Presentation - Complementary initiatives for public health (Franck Diafouka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complementary-initiatives-public-health-franck-diafouka_en.pdf"},
    {"id":"10698","name":"Presentation - Pharmacogenomics in rare diseases: Development strategy for ivacaftor as a therapy for cystic fibrosis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacogenomics-rare-diseases-development-strategy-ivacaftor-therapy-cystic-fibrosis_en.pdf"},
    {"id":"10703","name":"Presentation - Information for the use of medicines in the elderly (F. Cerreta, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-use-medicines-elderly-f-cerreta-ema_en.pdf"},
    {"id":"10707","name":"Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Parecoxib, Rofecoxib or Valdecoxib International Non-Proprietary Name (INN): Etoricoxib: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-04-30T02:08:21Z","last_updated_date":"2004-04-30T02:08:21Z","reference_number":"EMEA/CPMP/1748/04","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-all-medicinal-products-containing-celecoxib-etoricoxib-parecoxib-rofecoxib-or-valdecoxib-international-non-proprietary-name-inn-etoricoxib-background-information_en.pdf"},
    {"id":"10709","name":"Final assessment report on Thymus vulgaris L., Thymus zygis Loefl. ex. L., aetheroleum - Superseded","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/HMPC/131903/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-thymus-vulgaris-l-thymus-zygis-loefl-ex-l-aetheroleum-superseded_en.pdf"},
    {"id":"10710","name":"Presentation - Shortages survey 2015 (Maria-Jesus Alcaraz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-shortages-survey-2015-maria-jesus-alcaraz_en.pdf"},
    {"id":"10712","name":"Mutual recognition agreements: Sectoral Annex on Good Manufacturing practices - Issues related to Investigational Medicinal Products coverage from 1 May 2004","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-05-05T02:00:00Z","last_updated_date":"2004-05-05T02:00:00Z","reference_number":"EMEA/MRA/2/04","document_url":"https://www.ema.europa.eu/en/documents/other/mutual-recognition-agreements-sectoral-annex-good-manufacturing-practices-issues-related-investigational-medicinal-products-coverage-1-may-2004_en.pdf"},
    {"id":"10713","name":"Hydroxyzine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T17:00:00Z","last_updated_date":"2015-06-08T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyzine-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyzine-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyzine-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyzine-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyzine-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyzine-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyzine-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyzine-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyzine-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyzine-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyzine-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/hydroxyzine-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyzine-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyzine-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyzine-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyzine-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyzine-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyzine-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyzine-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyzine-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyzine-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyzine-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/hydroxyzine-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/hydroxyzine-article-31-referral-annex-i_no.pdf"}},
    {"id":"10714","name":"Presentation - The new veterinary medicines regulation and other new legislative acts - European Medicines Agency veterinary medicines innovation day (Josa Preuss)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-veterinary-medicines-regulation-and-other-new-legislative-acts-european-medicines-agency-veterinary-medicines-innovation-day-josa-preuss_en.pdf"},
    {"id":"10718","name":"Questions and answers on the recommendation to suspend the marketing authorisations for carisoprodol-containing medicines","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-15T00:08:21Z","last_updated_date":"2007-11-15T00:08:21Z","reference_number":"EMEA/520140/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-recommendation-suspend-marketing-authorisations-carisoprodol-containing-medicines_en.pdf"},
    {"id":"10721","name":"Overview of comments received on 'Guideline on the Requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled pro...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-09-20T02:00:00Z","last_updated_date":"2010-09-20T02:00:00Z","reference_number":"EMEA/CHMP/EWP/187653/2009  ","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-requirements-clinical-documentation-orally-inhaled-products-oip-including-requirements-demonstration-therapeutic-equivalence-between-two-inhaled-pro_en.pdf"},
    {"id":"10723","name":"EU/3/15/1518: Public summary of opinion on orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/426684/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151518-public-summary-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-2-containing-human-rpe65-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"10725","name":"Presentation - Pharmacovigilance in the European Union (Andrej Segec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-european-union-andrej-segec_en.pdf"},
    {"id":"10728","name":"Public statement on Clopidogrel Hexal: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-07-26T02:00:00Z","last_updated_date":"2012-07-26T02:00:00Z","reference_number":"EMA/328036/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-hexal-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"10729","name":"Presentation - Clinical exposure - response relationships (Evelyn Ellis-Grosse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-exposure-response-relationships-evelyn-ellis-grosse_en.pdf"},
    {"id":"10730","name":"Opinion following an Article 34 referral for Micotil 300 Injectie and its associated names","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"EMA/539469/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-34-referral-micotil-300-injectie-and-its-associated-names_sv.pdf"}},
    {"id":"10732","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 15-16 September 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/HMPC/592652/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-15-16-september-2010_en.pdf"},
    {"id":"10734","name":"Presentation - Paediatric Rheumatology InterNational Trials Organization (Nicola Ruperto, PRINTO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-rheumatology-international-trials-organization-nicola-ruperto-printo_en.pdf"},
    {"id":"10737","name":"Final community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-04-29T14:45:00Z","last_updated_date":"2014-04-29T14:45:00Z","reference_number":"EMA/HMPC/283630/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"10739","name":"European Medicines Agency recommends authorisation of novel treatment for type 2 diabetes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-04-20T14:01:12Z","last_updated_date":"2012-04-20T14:01:12Z","reference_number":"EMA/CHMP/257385/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-authorisation-novel-treatment-type-2-diabetes_en.pdf"},
    {"id":"10741","name":"CHMP summary of opinion for Zepatier","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/342247/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-zepatier_en.pdf"},
    {"id":"10742","name":"Agenda - CAT agenda of the 13-14 November 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T14:30:00Z","last_updated_date":"2014-11-24T14:30:00Z","reference_number":"EMA/CAT/706533/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-13-14-november-2014-meeting_en.pdf"},
    {"id":"10743","name":"Cypermethrin (Extension to salmonidae): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2003-01-01T01:00:00Z","last_updated_date":"2003-01-01T01:00:00Z","reference_number":"EMEA/MRL/861/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cypermethrin-extension-salmonidae-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10745","name":"Cover note - Revised criteria to be fulfilled by patients’ and consumers’ organisations involved in European Medicines Agency activities","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-10-07T16:00:02Z","last_updated_date":"2011-10-07T16:00:02Z","reference_number":"EMA/MB/744342/2011","document_url":"https://www.ema.europa.eu/en/documents/other/cover-note-revised-criteria-be-fulfilled-patients-and-consumers-organisations-involved-european-medicines-agency-activities_en.pdf"},
    {"id":"10746","name":"Finasteride: List of nationally authorised medicinal products       - PSUSA/00001392/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T17:01:00Z","last_updated_date":"2018-06-07T17:10:06Z","reference_number":"EMA/381051/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/finasteride-list-nationally-authorised-medicinal-products-psusa00001392201708_en.pdf"},
    {"id":"10747","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Wakix (pitolisant) for the treatment of narcolepsy","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-04-20T15:40:00Z","last_updated_date":"2016-04-20T15:40:00Z","reference_number":"EMA/COMP/156871/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-wakix-pitolisant-treatment-narcolepsy_en.pdf"},
    {"id":"10748","name":"EU/3/14/1391: Public summary of positive opinion for orphan designation: 5-[8-methyl-9-(1-methylethyl)-2-(4-morpholinyl)-9H-purin-6-yl]-2-pyrimidinamine for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2016-02-10T18:00:00Z","reference_number":"EMA/COMP/744278/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141391-public-summary-positive-opinion-orphan-designation-5-8-methyl-9-1-methylethyl-2-4-morpholinyl-9h-purin-6-yl-2-pyrimidinamine-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"10749","name":"EU/3/06/426: Public summary of positive opinion for orphan designation of fenretinide for the treatment of primary malignant bone tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2011-03-25T01:00:00Z","reference_number":"EMEA/COMP/96682/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306426-public-summary-positive-opinion-orphan-designation-fenretinide-treatment-primary-malignant-bone-tumours_en.pdf"},
    {"id":"10752","name":"Presentation - Holistic approach to paediatric research: ethics committees (M.A. Ribeiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:04:00Z","last_updated_date":"2018-06-18T12:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-ethics-committees-ma-ribeiro_en.pdf"},
    {"id":"10753","name":"Opinion of the HMPC on a European Union herbal monograph on Vaccinium myrtillus L., fructus recens","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"EMA/HMPC/642019/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-vaccinium-myrtillus-l-fructus-recens_en.pdf"},
    {"id":"10754","name":"Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-09-25T14:10:00Z","last_updated_date":"2014-09-25T14:10:00Z","reference_number":"CPMP/EWP/785/97 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products-treatment-irritable-bowel-syndrome-revision-1_en.pdf"},
    {"id":"10755","name":"Fibrinogen Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2013-04-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fibrinogen-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fibrinogen-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fibrinogen-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fibrinogen-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fibrinogen-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fibrinogen-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fibrinogen-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fibrinogen-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fibrinogen-article-31-referral-annex-iv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fibrinogen-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fibrinogen-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fibrinogen-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fibrinogen-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fibrinogen-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fibrinogen-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fibrinogen-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fibrinogen-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fibrinogen-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fibrinogen-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fibrinogen-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fibrinogen-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fibrinogen-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"10756","name":"Meeting highlights from the Paediatric Committee:  24 - 26 October 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-10-29T01:00:00Z","last_updated_date":"2007-10-29T01:00:00Z","reference_number":"EMEA/492629/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-24-26-october-2007_en.pdf"},
    {"id":"10758","name":"Final assessment report on Calendula officinalis L., flos - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-06-14T15:00:00Z","last_updated_date":"2018-06-14T15:00:00Z","reference_number":"EMA/HMPC/603409/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-calendula-officinalis-l-flos-revision-1_en.pdf"},
    {"id":"10759","name":"Agenda and registration form - EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area (Austria, Dec 2015)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-09-21T02:00:00Z","last_updated_date":"2015-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-european-economic-area-austria-dec-2015_en.pdf"},
    {"id":"10761","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - April 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T18:05:00Z","last_updated_date":"2012-04-30T18:05:00Z","reference_number":"EMA/262759/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-april-2012_en.pdf"},
    {"id":"10762","name":"Bismuth subnitrate (Extension to intramammary administration): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-10-01T02:00:00Z","last_updated_date":"1999-10-01T02:00:00Z","reference_number":"EMEA/MRL/705/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bismuth-subnitrate-extension-intramammary-administration-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10764","name":"Presentation - Histology-independent indications (Kristina Larsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:16:00Z","last_updated_date":"2018-06-06T17:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-histology-independent-indications-kristina-larsson_en.pdf"},
    {"id":"10765","name":"List of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 4 June 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-09-01T02:00:00Z","last_updated_date":"2015-09-01T02:00:00Z","reference_number":"EMA/167550/2015","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-4-june-2015_en.pdf"},
    {"id":"10766","name":"Human medicines highlights - February 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-03-06T15:30:00Z","last_updated_date":"2015-03-06T15:30:00Z","reference_number":"Issue 72","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-february-2015_en.pdf"},
    {"id":"10768","name":"Overview of comments received on list of paediatric needs - Immunology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-25T02:00:00Z","last_updated_date":"2006-09-25T02:00:00Z","reference_number":"EMEA/381452/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-list-paediatric-needs-immunology_en.pdf"},
    {"id":"10772","name":"High level business consultancy EMA/2013/23/FI - Technical specifications - Annex II exclusion criteria","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/high-level-business-consultancy-ema201323fi-technical-specifications-annex-ii-exclusion-criteria_en.doc"},
    {"id":"10774","name":"Recognition criteria and quality standards for members of the European Paediatric Research Network (EnprEMA) - Final results of the Delphi surveys","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-and-quality-standards-members-european-paediatric-research-network-enprema-final-results-delphi-surveys_en.pdf"},
    {"id":"10775","name":"Committee for Orphan Medicinal Products: May 2007 Meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-01T02:09:21Z","last_updated_date":"2007-06-01T02:09:21Z","reference_number":"EMEA/COMP/244638/07","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-may-2007-meeting_en.pdf"},
    {"id":"10776","name":"Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-02T13:21:00Z","last_updated_date":"2017-08-02T13:21:00Z","reference_number":"EMA/INS/GMP/443117/2017","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-production-water-injections-non-distillation-methods-reverse-osmosis-and-biofilms-and-control-strategies-final_en.pdf"},
    {"id":"10777","name":"Presentation - Extrapolation challenges in pediatric PAH  - Possible solutions for a feasible, global study (M. Bacchi, A. Morganti, P. Cornelisse, J. Bolognese, C. Lesage, A. Kà¼mmel, P. Nilsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-challenges-pediatric-pah-possible-solutions-feasible-global-study-m-bacchi-morganti-p-cornelisse-j-bolognese-c-lesage-ka-14mmel-p-nilsson_en.pdf"},
    {"id":"10778","name":"Presentation - Summary of product characteristics","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summary-product-characteristics_en.pdf"},
    {"id":"10781","name":"Environmental risk assessment for Human\n\nMedicinal products containing or consisting of GMOS","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-12-04T00:09:21Z","last_updated_date":"1998-12-04T00:09:21Z","reference_number":"3BR1a","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/environmental-risk-assessment-human-medicinal-products-containing-or-consisting-gmos_en.pdf"},
    {"id":"10782","name":"Public statement on Budesonide/Formoterol Teva: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-01-31T14:43:00Z","last_updated_date":"2017-01-31T14:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-budesonideformoterol-teva-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"10783","name":"Overview of comments received on European Union herbal monograph Valeriana officinalis L., radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-27T12:30:00Z","last_updated_date":"2016-04-27T12:30:00Z","reference_number":"EMA/HMPC/759056/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"10784","name":"Agenda - PRAC draft agenda of meeting 29-31 October 2012","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2012-10-29T09:28:00Z","last_updated_date":"2012-10-29T09:28:00Z","reference_number":"EMA/PRAC/519417/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-29-31-october-2012_en.pdf"},
    {"id":"10785","name":"EU/3/14/1239: Public summary of opinion on orphan designation: 11-(4-Dimethylamino-3-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-aza-cyclopentadecane-13,15-di...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-01T14:30:00Z","last_updated_date":"2014-04-01T14:30:00Z","reference_number":"EMA/COMP/26019/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141239-public-summary-opinion-orphan-designation-11-4-dimethylamino-3-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy-2-ethyl-3410-trihydroxy-3568101214-heptamethyl-1-oxa-6-aza-cyclopentadecane-1315-di_en.pdf"},
    {"id":"10787","name":"Anisi stellati fructus: Summary report  Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/710/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/anisi-stellati-fructus-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10789","name":"CHMP summary of opinion for Darzalex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/174469/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-darzalex_en.pdf"},
    {"id":"10790","name":"European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-22T17:00:00Z","last_updated_date":"2011-11-22T17:00:00Z","reference_number":"EMA/905564/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-interim-recommendations-deal-shortcomings-quality-assurance-ben-venue-laboratories_en.pdf"},
    {"id":"10791","name":"CHMP summary of positive opinion for Ozurdex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"EMA/CHMP/316582/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ozurdex_en.pdf"},
    {"id":"10792","name":"Presentation - Periodic safety update single assessment (PSUSA)  procedure EU reference dates (EURD) list and submission aspect (Menno Van Der Elst)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-periodic-safety-update-single-assessment-psusa-procedure-eu-reference-dates-eurd-list-and-submission-aspect-menno-van-der-elst_en.pdf"},
    {"id":"10793","name":"EU/3/09/681: Public summary of positive opinion for orphan designation of 6-chloro-2,3,4,9-tetrahydro-1H-carbazole-1-carboxamide for the treatment of Huntington’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-11-16T00:09:21Z","last_updated_date":"2009-11-16T00:09:21Z","reference_number":"EMEA/COMP/589945/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309681-public-summary-positive-opinion-orphan-designation-6-chloro-2349-tetrahydro-1h-carbazole-1-carboxamide-treatment-huntingtons-disease_en.pdf"},
    {"id":"10794","name":"Presentation - 2.1 Borrowing information at the planning stage (Kit Roes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-21-borrowing-information-planning-stage-kit-roes_en.pdf"},
    {"id":"10796","name":"Altrenogest (equidae and porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T15:00:00Z","last_updated_date":"2012-02-20T15:00:00Z","reference_number":"EMA/CVMP/487477/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/altrenogest-equidae-and-porcine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"10797","name":"Assessment report for Baxter dialysis solutions (Castlebar site)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"EMA/973411/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-baxter-dialysis-solutions-castlebar-site_en.pdf"},
    {"id":"10798","name":"EU/3/10/809: Public summary of opinion on orphan designation Nanoparticle albumin-bound paclitaxel for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2013-03-11T17:15:00Z","reference_number":"EMA/606364/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310809-public-summary-opinion-orphan-designation-nanoparticle-albumin-bound-paclitaxel-treatment-pancreatic-cancer_en.pdf"},
    {"id":"10800","name":"Presentation - Regulators perspective: using prior knowledge in applications - Session 1 (Mats Welin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulators-perspective-using-prior-knowledge-applications-session-1-mats-welin_en.pdf"},
    {"id":"10801","name":"Declaration of research interests (addendum) - Peter Helms","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-research-interests-addendum-peter-helms_en.pdf"},
    {"id":"10802","name":"Draft agenda - Visit of the Danish Association of the Pharmaceutical Industry","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/336081/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-visit-danish-association-pharmaceutical-industry_en.pdf"},
    {"id":"10803","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Signifor (pasireotide) for the treatment of acromegaly","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-01-21T01:00:00Z","last_updated_date":"2015-01-21T01:00:00Z","reference_number":"EMA/COMP/621067/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-signifor-pasireotide-treatment-acromegaly_en.pdf"},
    {"id":"10805","name":"Celecoxib - Article 31 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-06-09T02:08:21Z","last_updated_date":"2004-06-09T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/celecoxib-article-31-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"10806","name":"Presentation - Patient interaction with consumers - 10 years of PCWP (Francesca Cattarin, BEUC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-interaction-consumers-10-years-pcwp-francesca-cattarin-beuc_en.pdf"},
    {"id":"10807","name":"Overview of comments received on 'Draft guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 3'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-07-25T16:09:00Z","last_updated_date":"2016-07-25T16:09:00Z","reference_number":"EMA/CVMP/EWP/495905/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestation-dogs-and-cats-revision-3_en.pdf"},
    {"id":"10808","name":"Superseded community herbal monograph on Hedera helix L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-04-19T02:00:00Z","last_updated_date":"2016-01-18T01:00:00Z","reference_number":"EMA/HMPC/289430/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-hedera-helix-l-folium_en.pdf"},
    {"id":"10811","name":"EU/3/08/585: Public summary of positive opinion for orphan designation of\n\ndaunorubicin (liposomal) for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/558087/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308585-public-summary-positive-opinion-orphan-designation-daunorubicin-liposomal-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"10812","name":"Presentation - An SME perspective on the implementation of the EU Clinical Trials Regulation (Kate Darwin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T12:14:00Z","last_updated_date":"2017-03-30T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-perspective-implementation-eu-clinical-trials-regulation-kate-darwin_en.pdf"},
    {"id":"10813","name":"Hydroxyethyl starch Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2013-09-02T02:00:00Z","reference_number":"EMA/PRAC/751078/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"10814","name":"EU/3/15/1607: Public summary of opinion on orphan designation: Entolimod for the treatment of acute radiation syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2020-05-07T01:00:00Z","reference_number":"EMA/COMP/866871/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151607-public-summary-opinion-orphan-designation-entolimod-treatment-acute-radiation-syndrome_en.pdf"},
    {"id":"10817","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Calendula offilinalis L., flos - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-03-06T00:09:21Z","last_updated_date":"2018-06-15T01:09:21Z","reference_number":"EMEA/HMPC/590995/2007/EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-calendula-offilinalis-l-flos-first-version_en.pdf"},
    {"id":"10818","name":"Presentation - Topic 3 - Timely completion of the studies of paediatric investigation plans (PIPs): Industry perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (H....","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-3-timely-completion-studies-paediatric-investigation-plans-pips-industry-perspective-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-h_en.pdf"},
    {"id":"10820","name":"Presentation - Traditional validation: Upstream (Vijay Chiruvolu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-traditional-validation-upstream-vijay-chiruvolu_en.pdf"},
    {"id":"10823","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n23-26 June 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2008-06-26T02:09:21Z","reference_number":"EMEA/CHMP/332645/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-23-26-june-2008_en.pdf"},
    {"id":"10824","name":"Omega-3-acid-ethyl esters: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"10825","name":"Ikorel and Dancor Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ikorel-and-dancor-article-30-referral-annex-ii_sv.pdf"}},
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    {"id":"10830","name":"EMA restricts use of prostate cancer medicine Xofigo","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/500948/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-restricts-use-prostate-cancer-medicine-xofigo_en.pdf"},
    {"id":"10831","name":"Submission of comments on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (EMA/873138/2011)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-22T13:20:00Z","last_updated_date":"2012-02-22T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-good-pharmacovigilance-practices-module-vi-management-and-reporting-adverse-reactions-medicinal-products-ema8731382011_en.doc"},
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    {"id":"10833","name":"Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-03-11T16:20:00Z","last_updated_date":"2015-03-11T16:20:00Z","reference_number":"EMEA/CHMP/BMWP/32775/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-insulin-and-insulin-analogues-revision-1_en.pdf"},
    {"id":"10835","name":"Note for guidance for the determination of withdrawal periods for milk - Updated application software","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2002-05-15T02:00:00Z","last_updated_date":"2002-05-15T02:00:00Z","reference_number":"EMEA/CVMP/231/00/Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-determination-withdrawal-periods-milk-updated-application-software_en.pdf"},
    {"id":"10836","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 24 September 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-11-05T15:15:00Z","last_updated_date":"2012-11-05T15:15:00Z","reference_number":"EMA/HMPC/639244/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-24-september-2012_en.pdf"},
    {"id":"10837","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-12-19T19:00:00Z","last_updated_date":"2016-12-19T19:00:00Z","reference_number":"EMA/696815/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-ocaliva-obeticholic-acid-treatment-primary-biliary-cirrhosis_en.pdf"},
    {"id":"10841","name":"Position paper on the genotoxic and carcinogenic potential of phenolphthalein","type":"position","status":"Adopted","consultation_date":"","first_published_date":"1997-12-17T01:00:00Z","last_updated_date":"1997-12-17T01:00:00Z","reference_number":"CPMP/818/97","document_url":"https://www.ema.europa.eu/en/documents/position/position-paper-genotoxic-and-carcinogenic-potential-phenolphthalein_en.pdf"},
    {"id":"10843","name":"Final list of references supporting the assessment of Althaea officinalis L., radix","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T15:07:00Z","last_updated_date":"2016-11-04T15:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-althaea-officinalis-l-radix_en.pdf"},
    {"id":"10844","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-07-30T12:36:00Z","last_updated_date":"2018-07-30T12:36:00Z","reference_number":"EMA/443042/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-june-2018_en.pdf"},
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    {"id":"10849","name":"Annex II - Concession specification: costing sheet (EMA/2016/43/RS)","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:30:00Z","last_updated_date":"2016-09-06T12:30:00Z","reference_number":"EMA/2016/43/RS","document_url":"https://www.ema.europa.eu/en/documents/procurement/annex-ii-concession-specification-costing-sheet-ema201643rs_en.xls"},
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    {"id":"10874","name":"Copper chloride, copper gluconate, copper heptanoate, copper oxide, copper methionate, copper sulphate and dicopper oxide: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/431/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/copper-chloride-copper-gluconate-copper-heptanoate-copper-oxide-copper-methionate-copper-sulphate-and-dicopper-oxide-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"10878","name":"Tysabri Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-05-08T14:00:00Z","last_updated_date":"2015-05-08T14:00:00Z","reference_number":"EMA/PRAC/293316/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/tysabri-article-20-procedure-prac-list-questions_en.pdf"},
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    {"id":"10893","name":"Hydroxyethyl starch Article-107i procedure - Rationale for triggering","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-rationale-triggering_en.pdf"},
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    {"id":"10895","name":"Questions and answers on the refusal of the marketing authorisation for Qsiva (phentermine / topiramate)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-02-22T13:00:00Z","last_updated_date":"2013-02-22T13:00:00Z","reference_number":"EMA/109958/2013 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_sv.pdf"}},
    {"id":"10896","name":"EU/3/16/1694: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/451054/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161694-public-summary-opinion-orphan-designation-autologous-cd4-and-cd8-t-cells-transduced-lentiviral-vector-containing-affinity-enhanced-t-cell-receptor-targeting-new-york-esophageal-antigen_en.pdf"},
    {"id":"10897","name":"Agenda - CAT agenda of the 18-20 April 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-04-19T17:26:00Z","last_updated_date":"2018-04-19T17:26:00Z","reference_number":"EMA/CAT/247071/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-18-20-april-2018-meeting_en.pdf"},
    {"id":"10903","name":"Overview of comments received on the draft 'Questions and answers on benzoic acid and benzoates’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/349506/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-questions-and-answers-benzoic-acid-and-benzoates_en.pdf"},
    {"id":"10904","name":"Note for guidance on preclinical pharmacological and toxicological testing of vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-12-17T01:00:00Z","last_updated_date":"1997-12-17T01:00:00Z","reference_number":"CPMP/SWP/465/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-preclinical-pharmacological-and-toxicological-testing-vaccines_en.pdf"},
    {"id":"10905","name":"Nasonex Article-30 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-02-03T10:40:00Z","last_updated_date":"2015-02-03T10:40:00Z","reference_number":"EMA/37163/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/nasonex-article-30-referral-assessment-report_en.pdf"},
    {"id":"10906","name":"Draft list of references supporting the assessment of Chelidonium majus L., herba","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-01-18T01:00:00Z","last_updated_date":"2011-01-18T01:00:00Z","reference_number":"EMA/HMPC/369803/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-chelidonium-majus-l-herba_en.pdf"},
    {"id":"10907","name":"EU/3/11/905: Public summary of opinion on orphan designation: Kifunensine for the treatment of alpha sarcoglycanopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2014-06-19T02:00:00Z","reference_number":"EMA/COMP/657806/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311905-public-summary-opinion-orphan-designation-kifunensine-treatment-alpha-sarcoglycanopathy_en.pdf"},
    {"id":"10908","name":"CHMP ORGAM agenda for the meeting on 15 January 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-01-22T14:27:00Z","last_updated_date":"2018-01-22T14:27:00Z","reference_number":"EMA/26255/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-15-january-2018_en.pdf"},
    {"id":"10909","name":"Joint audit programme for EEA GMP inspectorates: Observed inspection checklist","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-08-08T02:00:00Z","last_updated_date":"2019-02-22T02:00:00Z","reference_number":"EMA/170408/2018 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-eea-gmp-inspectorates-observed-inspection-checklist_en.docx"},
    {"id":"10911","name":"Donation of European Medicines Agency assets no. EMA/2014/28/IS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/donation-european-medicines-agency-assets-no-ema201428is_en.pdf"},
    {"id":"10915","name":"Extraordinary meeting to finalise review of Anorectic Agents","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-09-09T02:00:00Z","last_updated_date":"1999-09-09T02:00:00Z","reference_number":"CPMP/2335/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/extraordinary-meeting-finalise-review-anorectic-agents_en.pdf"},
    {"id":"10916","name":"COMP meeting report on the review of applications for orphan designation: February 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-02-24T16:30:00Z","last_updated_date":"2016-02-25T17:30:00Z","reference_number":"EMA/COMP/65529/2016 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-february-2016_en.pdf"},
    {"id":"10917","name":"CHMP summary of positive opinion for Sirturo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/CHMP/771324/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sirturo_en.pdf"},
    {"id":"10918","name":"COMP report to the Commission in relation to Article 10 of Regulation 141/2000 on orphan medicinal products - Annex 2","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-07-25T02:00:00Z","last_updated_date":"2005-07-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/comp-report-commission-relation-article-10-regulation-1412000-orphan-medicinal-products-annex-2_en.pdf"},
    {"id":"10920","name":"Guideline on acceptability of invented names - Hanne Brokopp","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-09-11T02:09:21Z","last_updated_date":"2006-09-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/guideline-acceptability-invented-names-hanne-brokopp_en.pdf"},
    {"id":"10922","name":"CHMP summary of positive opinion for Omidria","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/289526/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-omidria_en.pdf"},
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    {"id":"10924","name":"Draft assessment report on Chelidonium majus L., herba","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-01-18T01:00:00Z","last_updated_date":"2011-01-18T01:00:00Z","reference_number":"EMA/HMPC/369801/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-chelidonium-majus-l-herba_en.pdf"},
    {"id":"10926","name":"EU/3/05/341: Public summary of positive opinion of imexon for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-08-08T02:00:00Z","last_updated_date":"2018-10-04T11:38:00Z","reference_number":"EMEA/COMP/22896/2006 Correction 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305341-public-summary-positive-opinion-imexon-treatment-ovarian-cancer_en.pdf"},
    {"id":"10927","name":"Screening for adverse reactions in EudraVigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T11:25:00Z","last_updated_date":"2016-12-21T11:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/screening-adverse-reactions-eudravigilance_en.pdf"},
    {"id":"10928","name":"Cefuroxime sodium (for intracameral use): List of nationally authorised medicinal products - PSUSA/00010206/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-24T01:00:00Z","last_updated_date":"2016-10-18T15:41:15Z","reference_number":"EMA/151248/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefuroxime-sodium-intracameral-use-list-nationally-authorised-medicinal-products-psusa00010206201505_en.pdf"},
    {"id":"10931","name":"CHMP summary of positive opinion for Leganto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2022-02-18T02:00:00Z","reference_number":"EMA/259223/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-leganto_en.pdf"},
    {"id":"10932","name":"Public statement on the recommendation to suspend the marketing authorisation for Orlaam (levacetylmethadol) in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2001-04-19T02:00:00Z","last_updated_date":"2001-04-19T02:00:00Z","reference_number":"EMEA/8776/01","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-recommendation-suspend-marketing-authorisation-orlaam-levacetylmethadol-european-union_en.pdf"},
    {"id":"10933","name":"Presentation - Pharmacovigilance Risk Assessment Committee (PRAC) feedback - EMA's PCWP and HCPWP joint meeting (R. Anderson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-risk-assessment-committee-prac-feedback-emas-pcwp-and-hcpwp-joint-meeting-r-anderson_en.pdf"},
    {"id":"10935","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Grazoprevir/elbasvir for the treatment of chronic hepatitis C","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/783373/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-grazoprevirelbasvir-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"10937","name":"EMEA public statement on antimicrobial preservatives in ophthalmic preparations for human use","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2009-12-08T00:09:21Z","last_updated_date":"2009-12-08T00:09:21Z","reference_number":"EMEA/622721/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-antimicrobial-preservatives-ophthalmic-preparations-human-use_en.pdf"},
    {"id":"10938","name":"Withdrawal assessment report for Diractin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-11-28T01:00:00Z","last_updated_date":"2008-11-28T01:00:00Z","reference_number":"EMEA/CHMP/435233/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-diractin_en.pdf"},
    {"id":"10939","name":"Erythromycin / tretinoin : List of nationally authorised medicinal products - PSUSA/00001259/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-13T13:33:00Z","last_updated_date":"2017-06-13T13:34:41Z","reference_number":"EMA/373339/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/erythromycin-tretinoin-list-nationally-authorised-medicinal-products-psusa00001259201610_en.pdf"},
    {"id":"10941","name":"Presentation - Welcome, PML - Balancing risks and benefits - the patients' view, Christoph Thalheim","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-welcome-pml-balancing-risks-and-benefits-patients-view-christoph-thalheim_en.pdf"},
    {"id":"10942","name":"EU/3/08/590: Public summary of positive opinion for orphan designationof2-[[3-({4-[(5-{2-[(3-fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}oxy)propyl](ethyl)amino]ethyl dihydrogen phosphate t...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2019-08-30T15:00:00Z","reference_number":"EMEA/COMP/546580/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308590-public-summary-positive-opinion-orphan-designationof2-3-4-5-2-3-fluorophenylamino-2-oxoethyl-1h-pyrazol-3-ylamino-quinazolin-7-yloxypropylethylaminoethyl-dihydrogen-phosphate-t_en.pdf"},
    {"id":"10946","name":"Work plan 2018 for the joint CVMP/CHMP working group on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (J3RsWG)","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-12-19T15:30:00Z","last_updated_date":"2017-12-19T15:30:00Z","reference_number":"EMA/CHMP/CVMP/3Rs/479556/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-2018-joint-cvmpchmp-working-group-application-3rs-replacement-reduction-and-refinement-regulatory-testing-medicinal-products-j3rswg_en.pdf"},
    {"id":"10947","name":"Medicago sativa extractum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/453/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/medicago-sativa-extractum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10948","name":"News bulletin for small and medium-sized enterprises - Issue 44","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-08-09T19:00:00Z","last_updated_date":"2018-08-09T19:00:00Z","reference_number":"Issue 44","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-44_en.pdf"},
    {"id":"10949","name":"List of participants of the European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 3 ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"EMA/291057/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-3_en.pdf"},
    {"id":"10951","name":"Questions and answers on refusal of the marketing authorisation for Heparesc (human heterologous liver cells)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/413158/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-heparesc-human-heterologous-liver-cells_sv.pdf"}},
    {"id":"10952","name":"Superseded opinion of the HMPC on a community herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2022-10-03T01:00:00Z","reference_number":"EMA/HMPC/888911/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-agropyron-repens-l-p-beauv-rhizoma_en.pdf"},
    {"id":"10954","name":"Workshop on risk-based quality management in clinical trials 2-3 December 2013: Summaries of the presentations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T18:00:00Z","last_updated_date":"2014-07-07T18:00:00Z","reference_number":"EMA/84016/2014","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-risk-based-quality-management-clinical-trials-2-3-december-2013-summaries-presentations_en.pdf"},
    {"id":"10957","name":"Superseded Community herbal monograph on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-01-21T11:20:00Z","last_updated_date":"2016-01-21T11:20:00Z","reference_number":"EMEA/HMPC/244569/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
    {"id":"10959","name":"Opinions following an Article 12 referral for Terfenadine International Non-Proprietary Name (INN): Terfenadine: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-10-22T02:08:21Z","last_updated_date":"1998-10-22T02:08:21Z","reference_number":"EMEA/34168/98","document_url":"https://www.ema.europa.eu/en/documents/referral/opinions-following-article-12-referral-terfenadine-international-non-proprietary-name-inn-terfenadine-background-information_en.pdf"},
    {"id":"10960","name":"EMA Management Board: highlights of October 2014 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-06T14:45:00Z","last_updated_date":"2014-10-06T14:45:00Z","reference_number":"EMA/606176/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-october-2014-meeting_en.pdf"},
    {"id":"10961","name":"Presentation - 2.2 Hierarchical models: a framework for evidence synthesis (Tim Friede)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-22-hierarchical-models-framework-evidence-synthesis-tim-friede_en.pdf"},
    {"id":"10963","name":"EU/3/16/1691: Public summary of opinion on orphan designation: 2-[4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)-phenoxymethyl]-quinoline succinic acid for the treatment of Huntington's disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2018-05-29T02:00:00Z","reference_number":"EMA/COMP/451043/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161691-public-summary-opinion-orphan-designation-2-4-1-methyl-4-pyridin-4-yl-1h-pyrazol-3-yl-phenoxymethyl-quinoline-succinic-acid-treatment-huntingtons-disease_en.pdf"},
    {"id":"10965","name":"Allium Cepa: Summary Report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/660/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/allium-cepa-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10966","name":"Questions and answers on allogenic mesenchymal stem cell-based products for veterinary use: specific questions on tumorigenicity","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-11-21T01:00:00Z","last_updated_date":"2017-11-21T01:00:00Z","reference_number":"EMA/CVMP/ADVENT/791465/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-allogenic-mesenchymal-stem-cell-based-products-veterinary-use-specific-questions-tumorigenicity_en.pdf"},
    {"id":"10969","name":"Presentation - Joint Interagency Antimicrobial Consumption and Resistance Analysis (JIACRA) report (Jordi Torren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T13:00:00Z","last_updated_date":"2015-04-20T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-interagency-antimicrobial-consumption-and-resistance-analysis-jiacra-report-jordi-torren_en.pdf"},
    {"id":"10970","name":"Presentation - Trials with neonates: desirable scientific approaches, their ethical issues and potential solutions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-trials-neonates-desirable-scientific-approaches-their-ethical-issues-and-potential-solutions_en.pdf"},
    {"id":"10971","name":"Continuous Quality Verification: an approach to process validation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-09-28T02:09:21Z","last_updated_date":"2009-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/continuous-quality-verification-approach-process-validation_en.pdf"},
    {"id":"10972","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Opdivo (nivolumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T01:00:00Z","last_updated_date":"2018-01-26T01:00:00Z","reference_number":"EMA/51006/2018","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opdivo-nivolumab_en.pdf"},
    {"id":"10973","name":"Diacerein Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-annex-iii_en.pdf-0"},
    {"id":"10977","name":"Teflubenzuron: Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/547/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/teflubenzuron-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"10978","name":"Presentation - GVP paediatrics highlights. Product- or population-specific considerations IV: Paediatric population (R. De Lisa, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gvp-paediatrics-highlights-product-or-population-specific-considerations-iv-paediatric-population-r-de-lisa-ema_en.pdf"},
    {"id":"10980","name":"Withdrawal assessment report for Voraxaze","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T02:00:00Z","last_updated_date":"2008-06-02T02:00:00Z","reference_number":"EMEA/CHMP/171907/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-voraxaze_en.pdf"},
    {"id":"10981","name":"Presentation - Day 2: Uveiitiis - Clinician/Academic view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-uveiitiis-clinicianacademic-view_en.pdf"},
    {"id":"10982","name":"Cytomegalovirus immunoglobulin: List of nationally authorised medicinal products - PSUSA/00000914/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-05T14:00:00Z","last_updated_date":"2016-10-17T20:25:31Z","reference_number":"EMA/639856/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cytomegalovirus-immunoglobulin-list-nationally-authorised-medicinal-products-psusa00000914201601_en.pdf"},
    {"id":"10983","name":"Draft guideline on the development of new medicinal products for the treatment of ulcerative colitis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-11-16T01:00:00Z","last_updated_date":"2006-11-16T01:00:00Z","reference_number":"CHMP/EWP/18463/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-new-medicinal-products-treatment-ulcerative-colitis_en.pdf"},
    {"id":"10984","name":"Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T12:30:00Z","last_updated_date":"2017-04-21T12:30:00Z","reference_number":"EMA/CVMP/IWP/123243/2006 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-immunological-veterinary-medicinal-products-intended-minor-use-or-minor-species-mumslimited-market-revision-3_en.pdf"},
    {"id":"10987","name":"Presentation - Update on European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) organisation. ESVAC 2011 data / report (Kari Grave, Jordi Torren, David Mackay, Arno Muller)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T13:00:00Z","last_updated_date":"2013-04-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-european-surveillance-veterinary-antimicrobial-consumption-esvac-organisation-esvac-2011-data-report-kari-grave-jordi-torren-david-mackay-arno-muller_en.pdf"},
    {"id":"10990","name":"Comparability of medicinal products containing biotechnology-derived proteins as active substance - quality issues (Superseded by ICH Q.5.E - CPMP/ICH/5721/03)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-12-11T01:00:00Z","last_updated_date":"2003-12-11T01:00:00Z","reference_number":"CPMP/BWP/3207/00 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/comparability-medicinal-products-containing-biotechnology-derived-proteins-active-substance-quality-issues-superseded-ich-q5e-cpmpich572103_en.pdf"},
    {"id":"10993","name":"Recommendations on the use of Caelyx (doxorubicin hydrochloride)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-11-22T16:59:00Z","last_updated_date":"2011-11-22T16:59:00Z","reference_number":"EMA/914175/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/recommendations-use-caelyx-doxorubicin-hydrochloride_en.pdf"},
    {"id":"10994","name":"CHMP summary of positive opinion Kyprolis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/627858/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kyprolis_en.pdf"},
    {"id":"10996","name":"Presentation - Conflicts of interests: Striking the right balance (Anja Holm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-conflicts-interests-striking-right-balance-anja-holm_en.pdf"},
    {"id":"11000","name":"Amiodarone: List of nationally authorised medicinal products -PSUSA/00000166/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-04T02:00:00Z","last_updated_date":"2016-10-17T19:40:19Z","reference_number":"EMA/586234/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/amiodarone-list-nationally-authorised-medicinal-products-psusa00000166201412_en.pdf"},
    {"id":"11001","name":"Withdrawal assessment report for Neocepri","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-14T02:00:00Z","last_updated_date":"2014-08-14T02:00:00Z","reference_number":"EMA/CHMP/691219/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-neocepri_en.pdf"},
    {"id":"11002","name":"Vecuronium bromide: List of nationally authorised medicinal products - PSUSA/00003102/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-04T18:30:00Z","last_updated_date":"2017-09-04T18:30:00Z","reference_number":"EMA/578853/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/vecuronium-bromide-list-nationally-authorised-medicinal-products-psusa00003102201611_en.pdf"},
    {"id":"11003","name":"EU/3/04/216: Public summary of positive opinion for orphan designation of sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid for the prevention of respiratory distress sy...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/COMP/376/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304216-public-summary-positive-opinion-orphan-designation-sinapultide-dipalmitoylphosphatidylcholine-palmitoyl-oleoyl-phosphatidylglycerol-and-palmitic-acid-prevention-respiratory-distress-sy_en.pdf"},
    {"id":"11004","name":"Final list of references supporting the assessment of Euphrasia officinalis L. and Euphrasia rostkoviana Hayne, herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/246817/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-euphrasia-officinalis-l-and-euphrasia-rostkoviana-hayne-herba_en.pdf"},
    {"id":"11006","name":"CHMP summary of positive opinion for Praxbind","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T14:00:00Z","last_updated_date":"2015-09-25T14:00:00Z","reference_number":"EMA/CHMP/575990/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-praxbind_en.pdf"},
    {"id":"11007","name":"Presentation - Closing remarks (David Tainsh, Keith Pugh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-closing-remarks-david-tainsh-keith-pugh_en.pdf"},
    {"id":"11008","name":"Press release - Conditional marketing authorisations give patients access to important new medicines earlier","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T01:00:00Z","last_updated_date":"2017-01-23T01:00:00Z","reference_number":"EMA/16151/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-conditional-marketing-authorisations-give-patients-access-important-new-medicines-earlier_en.pdf"},
    {"id":"11009","name":"EU/3/06/404: Public summary of positive opinion for orphan designation\n\nof adenoviral vector containing human p53 gene for the treatment of Li-Fraumeni syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/177051/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306404-public-summary-positive-opinion-orphan-designation-adenoviral-vector-containing-human-p53-gene-treatment-li-fraumeni-syndrome_en.pdf"},
    {"id":"11010","name":"Questions and answers on the outcome of extension of indication application for Exjade","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/254004/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-extension-indication-application-exjade_en.pdf"},
    {"id":"11015","name":"Conclusions from the Paediatric Rheumatology Expert Group Meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"EMA/836276/2010","document_url":"https://www.ema.europa.eu/en/documents/other/conclusions-paediatric-rheumatology-expert-group-meeting_en.pdf"},
    {"id":"11016","name":"Lansoprazol AbZ Pharma 15 mg and 30 mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-02-25T00:08:21Z","last_updated_date":"2006-02-25T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lansoprazol-abz-pharma-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"11018","name":"Letter of support to explore EEG utility to measure deficits in social recognition in people with autism spectrum disorders (ASD) and its potential to stratify patient groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T12:00:00Z","last_updated_date":"2015-12-09T12:00:00Z","reference_number":"EMA/794518/2015","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-explore-eeg-utility-measure-deficits-social-recognition-people-autism-spectrum-disorders-asd-and-its-potential-stratify-patient-groups_en.pdf"},
    {"id":"11020","name":"Paediatric Medicines - Fergal Donnelly","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-11-16T00:09:21Z","last_updated_date":"2009-11-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/paediatric-medicines-fergal-donnelly_en.pdf"},
    {"id":"11021","name":"CVMP post-authorisation summary of positive opinion for Loxicom","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"EMA/CVMP/63405/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-loxicom_en.pdf"},
    {"id":"11022","name":"Agenda - Second international awareness session for international regulators, academia and non-governmental organisations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-12-18T18:15:00Z","last_updated_date":"2018-02-13T18:00:00Z","reference_number":"EMA/829042/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-international-awareness-session-international-regulators-academia-and-non-governmental-organisations_en.pdf"},
    {"id":"11024","name":"COMP meeting report on the review of applications for orphan designation: October 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-10-13T17:57:00Z","last_updated_date":"2016-10-13T17:57:00Z","reference_number":"EMA/COMP/616664/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-october-2016_en.pdf"},
    {"id":"11026","name":"Mifepristone Article 29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/mifepristone-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/mifepristone-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/mifepristone-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/mifepristone-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/mifepristone-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/mifepristone-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/mifepristone-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/mifepristone-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/mifepristone-article-294-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/mifepristone-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/mifepristone-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/mifepristone-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/mifepristone-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/mifepristone-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/mifepristone-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/mifepristone-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/mifepristone-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/mifepristone-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/mifepristone-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/mifepristone-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/mifepristone-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/mifepristone-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"11028","name":"COMP meeting report on the review of applications for orphan designation: December 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T14:55:00Z","last_updated_date":"2016-12-19T14:55:00Z","reference_number":"EMA/COMP/747832/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-december-2016_en.pdf"},
    {"id":"11031","name":"Questions and answers on the refusal of the marketing authorisation for  Balaxur","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2013-03-11T13:30:00Z","reference_number":"EMA/CHMP/667674/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-balaxur_sv.pdf"}},
    {"id":"11033","name":"Tosylchloramide sodium (extension to bovine): Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-03-01T01:00:00Z","last_updated_date":"2001-03-01T01:00:00Z","reference_number":"EMEA/MRL/782/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tosylchloramide-sodium-extension-bovine-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11037","name":"Analysis and Assessment of the Executive Director’s Annual Activity Report 2010","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMA/MB/416690/2011","document_url":"https://www.ema.europa.eu/en/documents/other/analysis-and-assessment-executive-directors-annual-activity-report-2010_en.pdf"},
    {"id":"11039","name":"EU/3/08/593: Public summary of positive opinion for orphan designation of N2'-Deacetyl-N2'-[4-methyl-4-(oxobuthyldithio)-1-oxopentyl]-maytansine-himerized anti-CD138 IgG4 monoclonal antibody for the treatment of multiple...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/568150/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308593-public-summary-positive-opinion-orphan-designation-n2-deacetyl-n2-4-methyl-4-oxobuthyldithio-1-oxopentyl-maytansine-himerized-anti-cd138-igg4-monoclonal-antibody-treatment-multiple_en.pdf"},
    {"id":"11040","name":"Agenda - Workshop on development of antibacterial medicinal products for paediatric patients","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-05-24T02:00:00Z","last_updated_date":"2018-10-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-development-antibacterial-medicinal-products-paediatric-patients_en.pdf"},
    {"id":"11042","name":"Presentation - European CRO Federation (EUCROF) (Stefano Marini)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-cro-federation-eucrof-stefano-marini_en.pdf"},
    {"id":"11043","name":"Draft list of references supporting the assessment of Citrus bergamia Risso et Poiteau, aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-10-19T18:30:05Z","last_updated_date":"2011-10-19T18:30:05Z","reference_number":"EMA/HMPC/56157/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-citrus-bergamia-risso-et-poiteau-aetheroleum_en.pdf"},
    {"id":"11046","name":"Tylosin Article-35 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-31T02:00:00Z","last_updated_date":"2017-07-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tylosin-article-35-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"11047","name":"CHMP summary of positive opinion for Controloc Control","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-19T01:00:00Z","last_updated_date":"2009-02-19T01:00:00Z","reference_number":"EMEA/CHMP/108578/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-controloc-control_en.pdf"},
    {"id":"11048","name":"CHMP summary of positive opinion for Nivolumab BMS","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2016-01-14T01:00:00Z","reference_number":"EMA/CHMP/310230/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nivolumab-bms_en.pdf"},
    {"id":"11050","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 20-23 March 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-03-24T00:09:21Z","last_updated_date":"2006-03-24T00:09:21Z","reference_number":"EMEA/106554/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-20-23-march-2006_en.pdf"},
    {"id":"11051","name":"Summary on compassionate use for Daclatasvir","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T10:40:00Z","last_updated_date":"2020-10-26T11:00:00Z","reference_number":"EMA/797185/2013","document_url":"https://www.ema.europa.eu/en/documents/other/summary-compassionate-use-daclatasvir_en.pdf"},
    {"id":"11054","name":"Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T15:59:00Z","last_updated_date":"2016-09-21T16:00:00Z","reference_number":"EMA/INS/GMP/733843/2015","document_url":"https://www.ema.europa.eu/en/documents/report/annual-report-good-manufacturing-and-distribution-practice-inspectors-working-group-2015_en.pdf"},
    {"id":"11055","name":"CHMP post-authorisation summary of positive opinion for Jalra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/600945/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jalra_en.pdf"},
    {"id":"11056","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Peumus boldus Molina, folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2009-01-15T00:09:21Z","last_updated_date":"2017-01-12T10:29:00Z","reference_number":"EMEA/HMPC/11543/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-peumus-boldus-molina-folium_en.pdf"},
    {"id":"11058","name":"List of references supporting the assessment of Phaseolus vulgaris L., fructus sine semine","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2014-01-17T16:00:00Z","last_updated_date":"2014-01-17T16:00:00Z","reference_number":"EMA/HMPC/317318/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-phaseolus-vulgaris-l-fructus-sine-semine_en.pdf"},
    {"id":"11060","name":"EMA Management Board: highlights of June 2016 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T16:30:00Z","last_updated_date":"2016-06-17T16:30:00Z","reference_number":"EMA/415244/2016 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-june-2016-meeting_en.pdf"},
    {"id":"11062","name":"Presentation - CAT feedback (K. Breen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:50:00Z","last_updated_date":"2017-12-11T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cat-feedback-k-breen_en.pdf"},
    {"id":"11063","name":"Presentation - Regulatory scene setting: Benefits and risks of seamless phase I / II trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-scene-setting-benefits-and-risks-seamless-phase-i-ii-trials_en.pdf"},
    {"id":"11065","name":"Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-12-14T01:00:00Z","last_updated_date":"2010-12-14T01:00:00Z","reference_number":"EMA/193771/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-tildren-500-mg-lyophilisate-solution-infusion-background-information_sv.pdf"}},
    {"id":"11066","name":"Antithrombin iii: List of nationally authorised medicinal products - PSUSA/00003159/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-24T16:57:00Z","last_updated_date":"2016-10-25T11:36:26Z","reference_number":"EMA/701785/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/antithrombin-iii-list-nationally-authorised-medicinal-products-psusa00003159201512_en.pdf"},
    {"id":"11068","name":"Manure degradation studies experiences - Gregor Scheef","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:09:21Z","last_updated_date":"2009-06-23T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/manure-degradation-studies-experiences-gregor-scheef_en.pdf"},
    {"id":"11070","name":"CHMP summary of positive opinion for Pumarix","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"EMA/CHMP/692469/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pumarix_en.pdf"},
    {"id":"11075","name":"Papain: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/036/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/papain-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11076","name":"Report – Meeting with stakeholders on monitoring sales of veterinary antimicrobial agents in Europe","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-12-22T13:01:31Z","last_updated_date":"2010-12-22T13:01:31Z","reference_number":"EMA/706703/2010","document_url":"https://www.ema.europa.eu/en/documents/report/report-meeting-stakeholders-monitoring-sales-veterinary-antimicrobial-agents-europe_en.pdf"},
    {"id":"11079","name":"Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-11-24T11:10:00Z","last_updated_date":"2014-11-24T11:10:00Z","reference_number":"EMA/CHMP/CVMP/SWP/169430/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different-medicinal-products-shared-facilities_en.pdf"},
    {"id":"11080","name":"CHMP summary of positive opinion for Tremfya","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/CHMP/556833/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tremfya_en.pdf"},
    {"id":"11081","name":"Atropa belladonna: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-12-01T01:00:00Z","last_updated_date":"1998-12-01T01:00:00Z","reference_number":"EMEA/MRL/540/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/atropa-belladonna-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11084","name":"EU/3/11/940: Public summary of positive opinion for orphan designation: Chimeric locked nucleic acid-deoxynucleoside phosphorothioate-linked oligonucleotide directed against microRNA-451 for the treatment of polycythaemi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2017-05-17T16:00:00Z","reference_number":"EMA/COMP/922838/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311940-public-summary-positive-opinion-orphan-designation-chimeric-locked-nucleic-acid-deoxynucleoside-phosphorothioate-linked-oligonucleotide-directed-against-microrna-451-treatment-polycythaemi_en.pdf"},
    {"id":"11085","name":"Rosuvastatin: List of nationally authorised medicinal products - PSUSA/00002664/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-31T11:27:00Z","last_updated_date":"2018-08-31T11:36:39Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/rosuvastatin-list-nationally-authorised-medicinal-products-psusa00002664201711_en.pdf"},
    {"id":"11086","name":"Minutes of the 83rd meeting of the Management Board: 19-20 March 2014","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2014-05-27T11:30:00Z","last_updated_date":"2014-05-27T11:30:00Z","reference_number":"EMA/MB/169928/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-83rd-meeting-management-board-19-20-march-2014_en.pdf"},
    {"id":"11087","name":"Mandate, objectives and rules of procedure for HMPC temporary working parties and drafting groups","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2009-12-16T01:00:00Z","last_updated_date":"2017-06-29T12:20:00Z","reference_number":"EMEA/HMPC/644241/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/work-programme/mandate-objectives-and-rules-procedure-hmpc-temporary-working-parties-and-drafting-groups_en.pdf"},
    {"id":"11089","name":"Hexoprenaline sulphate: List of nationally authorised products - PSUSA/00003170/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-03T02:00:00Z","last_updated_date":"2016-10-17T17:15:00Z","reference_number":"EMA/316582/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/hexoprenaline-sulphate-list-nationally-authorised-products-psusa00003170201508_en.pdf"},
    {"id":"11090","name":"CTAG2: Advice to the European Medicines Agency on Clinical Trial Advisory Group on clinical-trial-data formats - Final draft advice outcome with comments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag2-advice-european-medicines-agency-clinical-trial-advisory-group-clinical-trial-data-formats-final-draft-advice-outcome-comments_en.pdf"},
    {"id":"11094","name":"Final community herbal monograph on Vitex agnus-castus L., fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-01-31T01:00:00Z","reference_number":"EMA/HMPC/144006/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-vitex-agnus-castus-l-fructus_en.pdf"},
    {"id":"11095","name":"Presentation - Proposal for an Enpr-EMA webinar (John Watson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T13:45:00Z","last_updated_date":"2016-10-28T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-enpr-ema-webinar-john-watson_en.pdf"},
    {"id":"11097","name":"UCUM units for E2B (R3) version 1.2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-07-11T14:15:00Z","last_updated_date":"2018-11-28T17:00:00Z","reference_number":"Version 1.2","document_url":"https://www.ema.europa.eu/en/documents/other/ucum-units-e2b-r3-version-12_en.xlsx"},
    {"id":"11099","name":"Pirlimycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-07-01T02:00:00Z","last_updated_date":"1998-07-01T02:00:00Z","reference_number":"EMEA/MRL/460/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/pirlimycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11100","name":"Committee for Medicinal Products for Human Use (CHMP) - November 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-11-26T01:00:00Z","last_updated_date":"2010-11-26T01:00:00Z","reference_number":"EMA/CHMP/739938/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-november-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"11105","name":"Specific requirements for the production and control of allergen products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1994-09-01T02:00:00Z","last_updated_date":"1994-09-01T02:00:00Z","reference_number":"7BIm11a Volume 7","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/specific-requirements-production-and-control-allergen-products_en.pdf"},
    {"id":"11108","name":"Paper for information (PK-PD modelling by Prof. P. Lees)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/paper-information-pk-pd-modelling-prof-p-lees_en.pdf"},
    {"id":"11110","name":"Presentation - Procedures and support to developers (Patrick Celis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T02:00:00Z","last_updated_date":"2014-10-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedures-and-support-developers-patrick-celis_en.pdf"},
    {"id":"11111","name":"EMEA map","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-06-29T02:00:00Z","last_updated_date":"2010-04-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/emea-map_en.pdf"},
    {"id":"11115","name":"Presentation - Multiplicity and estimation (Peter Bauer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multiplicity-and-estimation-peter-bauer_en.pdf"},
    {"id":"11116","name":"Routes of administration of vaccines to poultry","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T16:15:00Z","last_updated_date":"2013-11-18T16:15:00Z","reference_number":"EMA/CVMP/IWP/640481/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/routes-administration-vaccines-poultry_en.pdf"},
    {"id":"11117","name":"Draft community herbal monograph on Sambucus nigra L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-09-07T02:09:21Z","last_updated_date":"2007-09-07T02:09:21Z","reference_number":"EMEA/HMPC/283166/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-sambucus-nigra-l-flos_en.pdf"},
    {"id":"11120","name":"Pre-qualification questionnaire for a restricted tender procedure organised by the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-03T12:00:00Z","last_updated_date":"2013-04-03T12:00:00Z","reference_number":"EMA/2012/54/IS ","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-restricted-tender-procedure-organised-european-medicines-agency_en.doc"},
    {"id":"11128","name":"Agenda - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-07-30T12:25:00Z","last_updated_date":"2018-11-20T16:58:00Z","reference_number":"EMA/493240/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies_en.pdf"},
    {"id":"11129","name":"Sodium nitrite: Summary Report – Committee for Medicinal Products for Veterinary use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-04-01T02:00:00Z","last_updated_date":"2006-04-01T02:00:00Z","reference_number":"EMEA/CVMP/116350/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sodium-nitrite-summary-report-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"11130","name":"Clotiazepam: List of nationally authorised medicinal products - PSUSA/00000827/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T13:00:00Z","last_updated_date":"2016-10-17T20:16:37Z","reference_number":"EMA/60980/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/clotiazepam-list-nationally-authorised-medicinal-products-psusa00000827201505_en.pdf"},
    {"id":"11133","name":"European Medicines Agency recommends lifting suspension of aprotinin","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T11:10:31Z","last_updated_date":"2012-02-17T11:10:31Z","reference_number":"EMA/CHMP/119704/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-lifting-suspension-aprotinin_en.pdf"},
    {"id":"11134","name":"News bulletin for small and medium-sized enterprises - Issue 43","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-05-14T16:27:00Z","last_updated_date":"2018-05-14T16:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-43_en.pdf"},
    {"id":"11135","name":"Concept paper on the development of a CHMP guideline on the clinical investigation of medicinal products for the treatment of pulmonary hypertension","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T01:00:00Z","last_updated_date":"2008-01-24T01:00:00Z","reference_number":"EMEA/CHMP/EWP/566954/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-chmp-guideline-clinical-investigation-medicinal-products-treatment-pulmonary-hypertension_en.pdf"},
    {"id":"11138","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 16-19 December 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/730980/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-16-19-december-2013_en.pdf"},
    {"id":"11139","name":"CHMP post-authorisation summary of positive opinion for Pritor","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/CHMP/261191/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pritor_en.pdf"},
    {"id":"11141","name":"Data Elements for Transmission of Individual Case Safety Reports (ICSRs) - Ayumi Endo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/data-elements-transmission-individual-case-safety-reports-icsrs-ayumi-endo_en.pdf"},
    {"id":"11142","name":"Presentation - Patients' and Consumers' Working Party (PCWP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T16:00:00Z","last_updated_date":"2016-02-15T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-and-consumers-working-party-pcwp_en.pdf"},
    {"id":"11143","name":"Public statement on interaction between clopidogrel and proton-pump inhibitors","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2010-03-17T01:00:00Z","last_updated_date":"2010-03-17T01:00:00Z","reference_number":"EMA/174948/2010","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-interaction-between-clopidogrel-and-proton-pump-inhibitors_en.pdf"},
    {"id":"11144","name":"Final list of references supporting the assessment of Andrographis paniculata Nees, folium - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2014-06-10T02:00:00Z","last_updated_date":"2014-08-28T13:05:00Z","reference_number":"EMA/HMPC/320452/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-andrographis-paniculata-nees-folium-first-version_en.pdf"},
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    {"id":"11151","name":"Assessment report for Fenofibrato Pensa and Fenofibrato Ranbaxy","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"EMA/20843/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-fenofibrato-pensa-and-fenofibrato-ranbaxy_en.pdf"},
    {"id":"11154","name":"Committee for medicinal products for human use  summary of positive opinion  for Zyllt","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-24T02:00:00Z","last_updated_date":"2009-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-zyllt_en.pdf"},
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    {"id":"11163","name":"Draft concept paper on the impact of liver immaturity when investigating medicinal products intended for neonatal use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-07-20T02:00:00Z","last_updated_date":"2005-07-20T02:00:00Z","reference_number":"EMEA/CHMP/PEG/194605/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-impact-liver-immaturity-when-investigating-medicinal-products-intended-neonatal-use_en.pdf"},
    {"id":"11164","name":"EU/3/12/979: Public summary of opinion on orphan designation: Sodium thiosulfate for the treatment of calciphylaxis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-04-30T02:00:00Z","reference_number":"EMA/COMP/142664/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312979-public-summary-opinion-orphan-designation-sodium-thiosulfate-treatment-calciphylaxis_en.pdf"},
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    {"id":"11168","name":"Presentation - Centralised-procedure extension to Croatia: Industry perspective (Mislav VuÄić)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-extension-croatia-industry-perspective-mislav-vuaia_en.pdf"},
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    {"id":"11180","name":"News bulletin for pharmacovigilance programme update - Issue 2","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-12-11T17:40:00Z","last_updated_date":"2014-12-11T17:40:00Z","reference_number":"Issue 2","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-pharmacovigilance-programme-update-issue-2_en.pdf"},
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    {"id":"11186","name":"PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-06T13:00:00Z","last_updated_date":"2013-12-06T13:00:00Z","reference_number":"EMA/741427/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-considers-benefits-kogenate-bayerhelixate-nexgen-outweigh-risks-previously-untreated-patients_en.pdf"},
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    {"id":"11190","name":"Purple coneflower herb - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2015-10-20T12:45:00Z","last_updated_date":"2016-02-17T11:55:00Z","reference_number":"EMA/481797/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/purple-coneflower-herb-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/purple-coneflower-herb-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/purple-coneflower-herb-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/purple-coneflower-herb-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/purple-coneflower-herb-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/purple-coneflower-herb-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/purple-coneflower-herb-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/purple-coneflower-herb-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/purple-coneflower-herb-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/purple-coneflower-herb-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/purple-coneflower-herb-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/purple-coneflower-herb-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/purple-coneflower-herb-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/purple-coneflower-herb-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/purple-coneflower-herb-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/purple-coneflower-herb-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/purple-coneflower-herb-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/purple-coneflower-herb-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/purple-coneflower-herb-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/purple-coneflower-herb-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/purple-coneflower-herb-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/purple-coneflower-herb-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/purple-coneflower-herb-summary-public_sv.pdf"}},
    {"id":"11191","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) reference sources","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:01Z","last_updated_date":"2014-01-17T18:15:00Z","reference_number":"EMA/136145/2012 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-reference-sources_en.xls"},
    {"id":"11193","name":"Presentation - Pharmacovigilance fees (Michael Lenihan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-fees-michael-lenihan_en.pdf"},
    {"id":"11194","name":"Overview of comments received on 'Community herbal monograph on Solidago virgaurea L., herba' (EMEA/HMPC/285758/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/102215/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-solidago-virgaurea-l-herba-emeahmpc2857582007_en.pdf"},
    {"id":"11195","name":"Overview of comments received on Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T17:54:00Z","last_updated_date":"2017-01-03T17:54:00Z","reference_number":"EMA/CHMP/620297/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-levodopacarbidopaentacapone-film-coated-tablet-200-mg50-mg200-mg-175-mg4375-mg200-mg-150-mg375-mg200-mg-125-mg3125-mg200-mg-100-mg25-mg200-mg-75-mg1875-mg200-mg-and_en.pdf"},
    {"id":"11196","name":"Withdrawal letter: Aripiprazole Mylan","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aripiprazole-mylan_en.pdf-0"},
    {"id":"11197","name":"Questions and answers on the review of Multaq (dronedarone)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-09-22T02:00:00Z","last_updated_date":"2011-09-22T02:00:00Z","reference_number":"EMA/CHMP/706259/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-multaq-dronedarone_en.pdf"},
    {"id":"11200","name":"Committee for Proprietary Medicinal Products (CPMP) 39th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-06-29T02:00:00Z","last_updated_date":"1998-06-29T02:00:00Z","reference_number":"CPMP/1150/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-39th-plenary-meeting_en.pdf"},
    {"id":"11201","name":"EU/3/17/1926: Public summary of opinion on orphan designation : Ofranergene obadenovec for the treatment of ovarian cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T11:37:00Z","last_updated_date":"2022-09-26T11:37:00Z","reference_number":"EMA/632137/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171926-public-summary-opinion-orphan-designation-ofranergene-obadenovec-treatment-ovarian-cancer_en.pdf"},
    {"id":"11202","name":"Durogesic Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T02:00:00Z","last_updated_date":"2016-10-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/durogesic-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/durogesic-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/durogesic-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/durogesic-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/durogesic-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/durogesic-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/durogesic-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/durogesic-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/durogesic-article-30-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/durogesic-article-30-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/durogesic-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/durogesic-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/durogesic-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/durogesic-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/durogesic-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/durogesic-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/durogesic-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/durogesic-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/durogesic-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/durogesic-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/durogesic-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/durogesic-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/durogesic-article-30-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/durogesic-article-30-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/durogesic-article-30-referral-annex-i_no.pdf"}},
    {"id":"11208","name":"Gentamicin Article-35 referral - Divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gentamicin-article-35-referral-divergent-position_en.pdf"},
    {"id":"11210","name":"CHMP post-authorisation summary of positive opinion for Gilenya","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/243755/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-gilenya_en.pdf"},
    {"id":"11211","name":"Committee on herbal medicinal products (HMPC): Meeting report, 11-12 March 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-03-31T02:00:00Z","last_updated_date":"2009-03-31T02:00:00Z","reference_number":"EMEA/HMPC/192861/2009 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-11-12-march-2009_en.pdf"},
    {"id":"11212","name":"Final opinion of the HMPC on Hedera helix  L., folium  - Revision 2","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2018-08-13T13:47:00Z","last_updated_date":"2018-08-13T13:47:00Z","reference_number":"EMA/HMPC/769686/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-hedera-helix-l-folium-revision-2_en.pdf"},
    {"id":"11213","name":"Standard operating procedure for preparation of ‘lines-to-take’ documents for use within the European Union regulatory network to answer external queries in a consistent manner","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2011-04-14T02:00:00Z","last_updated_date":"2011-04-14T02:00:00Z","reference_number":"SOP/H/3347","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-lines-take-documents-use-within-european-union-regulatory-network-answer-external-queries-consistent-manner_en.pdf"},
    {"id":"11216","name":"S2(R1) Revision of the Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use - Peter Kasper","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/s2r1-revision-guidance-genotoxicity-testing-and-data-interpretation-pharmaceuticals-intended-human-use-peter-kasper_en.pdf"},
    {"id":"11217","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous adipose tissue derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T15:30:00Z","last_updated_date":"2016-04-19T15:30:00Z","reference_number":"EMA/240982/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-adipose-tissue-derived-mesenchymal-stem-cells_en.pdf-0"},
    {"id":"11218","name":"Agenda - Info day for micro, small and medium-sized enterprises: regulatory toolbox for medicines and combined devices developers","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-05-14T17:00:00Z","last_updated_date":"2018-10-25T15:00:00Z","reference_number":"EMA/150123/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-info-day-micro-small-and-medium-sized-enterprises-regulatory-toolbox-medicines-and-combined-devices-developers_en.pdf"},
    {"id":"11219","name":"Declaration of interests: Jean-Claude Brival","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:15Z","last_updated_date":"2012-08-28T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-jean-claude-brival_en.pdf"},
    {"id":"11221","name":"CHMP post authorisation summary of positive opinion for PegIntron on 24 September 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2021-06-03T02:00:00Z","reference_number":"EMEA/CHMP/609368/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pegintron-24-september-2009_en.pdf"},
    {"id":"11222","name":"Committee for Proprietary Medicinal Products (CPMP) 24th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-02-20T01:00:00Z","last_updated_date":"1997-02-20T01:00:00Z","reference_number":"CPMP/182/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-24th-plenary-meeting_en.pdf"},
    {"id":"11223","name":"Presentation - Access to EudraVigilance data – demonstration","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-access-eudravigilance-data-demonstration_en.pdf-0"},
    {"id":"11224","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-08-10T11:37:00Z","last_updated_date":"2017-08-10T11:37:00Z","reference_number":"EMA/436821/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-july-2017_en.pdf"},
    {"id":"11225","name":"CHMP summary of positive opinion for Cometriq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/CHMP/539526/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cometriq_en.pdf"},
    {"id":"11227","name":"EU/3/07/455: Public summary of positive opinion for orphan designation of ciclosporin for the prevention of corneal graft rejection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMEA/COMP/466593/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307455-public-summary-positive-opinion-orphan-designation-ciclosporin-prevention-corneal-graft-rejection_en.pdf"},
    {"id":"11231","name":"Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for Numeta G16%E","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/564255/2013  ","document_url":"https://www.ema.europa.eu/en/documents/press-release/numeta-g13e-be-suspended-and-new-risk-minimisation-measures-be-introduced-numeta-g16e_en.pdf"},
    {"id":"11233","name":"Quality requirements for cell-based medicinal products - Paula Salmikangas","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/quality-requirements-cell-based-medicinal-products-paula-salmikangas_en.pdf"},
    {"id":"11234","name":"Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-03-23T01:00:00Z","last_updated_date":"2016-03-23T01:00:00Z","reference_number":"EMA/CHMP/41230/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-clinical-investigation-medicinal-products-treatment-venous-thromboembolic-disease_en.pdf"},
    {"id":"11238","name":"Product information – Hilde Boone","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-08T02:00:00Z","last_updated_date":"2003-05-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/product-information-hilde-boone_en.pdf"},
    {"id":"11239","name":"Monthly report - Pharmacovigilance Working Party (PhVWP) May 2011 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/CHMP/PhVWP/394737/2011","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-may-2011-plenary-meeting_en.pdf"},
    {"id":"11241","name":"CVMP post-authorisation summary of positive opinion for Advocate (II/0039/G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-01-19T01:00:00Z","last_updated_date":"2018-01-19T01:00:00Z","reference_number":"EMA/CVMP/825952/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-advocate-ii0039g_en.pdf"},
    {"id":"11242","name":"Agenda - CAT agenda of the 13-14 March 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-03-20T14:45:00Z","last_updated_date":"2014-03-20T14:45:00Z","reference_number":"EMA/CAT/150740/2014 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-13-14-march-2014-meeting_en.pdf"},
    {"id":"11244","name":"Committee for Medicinal Products for Human Use (CHMP) - February 2008 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-03-03T01:00:00Z","last_updated_date":"2008-03-03T01:00:00Z","reference_number":"EMEA/95268/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-february-2008-plenary-meeting-monthly-report_en.pdf"},
    {"id":"11247","name":"Presentation - Accelerated assessment (AA): review of 10 months experience with the new AA process (Victoria Palmi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-16T16:30:00Z","last_updated_date":"2018-01-16T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accelerated-assessment-aa-review-10-months-experience-new-aa-process-victoria-palmi_en.pdf"},
    {"id":"11248","name":"CHMP summary of positive opinion for Fampyra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/396600/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fampyra_en.pdf"},
    {"id":"11249","name":"Draft list of references for assessment of: Hippocastani semen Aesculus hippocastanum L., semen (horse chestnut seed)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/225629/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-hippocastani-semen-aesculus-hippocastanum-l-semen-horse-chestnut-seed_en.pdf"},
    {"id":"11250","name":"Questions and answers on the referral for Meronem and associated names meropenem powder for solution for injection or infusion 500 mg and 1 g","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-07-23T02:08:21Z","last_updated_date":"2009-07-23T02:08:21Z","reference_number":"EMEA/CHMP/466849/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-meronem-and-associated-names-meropenem-powder-solution-injection-or-infusion-500-mg-and-1-g_en.pdf"},
    {"id":"11252","name":"Chloroquine: List of nationally authorised medicinal products - PSUSA/00000685/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-18T15:41:12Z","reference_number":"EMA/344135/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/chloroquine-list-nationally-authorised-medicinal-products-psusa00000685201508_en.pdf"},
    {"id":"11256","name":"EU/3/02/085: Public summary of positive opinion for orphan designation of carmustine (solution for intratumoural injection) for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-23T00:00:00Z","last_updated_date":"2013-10-18T01:00:00Z","reference_number":"EMEA/COMP/46/2002 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302085-public-summary-positive-opinion-orphan-designation-carmustine-solution-intratumoural-injection-treatment-glioma_en.pdf"},
    {"id":"11259","name":"Plan for implementation of the pharmacovigilance legislation by the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T10:30:00Z","last_updated_date":"2012-02-02T10:30:00Z","reference_number":"EMA/64750/2012 ","document_url":"https://www.ema.europa.eu/en/documents/other/plan-implementation-pharmacovigilance-legislation-european-medicines-agency_en.pdf"},
    {"id":"11260","name":"Presentation - Session 2.3 - Working Group on Young People Advisory Groups (Pamela Dicks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-16T02:00:00Z","last_updated_date":"2017-06-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-23-working-group-young-people-advisory-groups-pamela-dicks_en.pdf"},
    {"id":"11263","name":"EU/3/15/1523: Public summary of opinion on orphan designation: Inecalcitol for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T02:00:00Z","last_updated_date":"2015-08-18T02:00:00Z","reference_number":"EMA/COMP/431519/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151523-public-summary-opinion-orphan-designation-inecalcitol-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"11265","name":"Overview of comments received on 'Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-03-26T17:30:00Z","last_updated_date":"2015-03-26T17:30:00Z","reference_number":"EMA/CHMP/68390/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-paediatric-addendum-note-guidance-clinical-investigation-medicinal-products-treatment-hypertension_en.pdf"},
    {"id":"11268","name":"CHMP summary of opinion for Zalmoxis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/380467/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-zalmoxis_en.pdf"},
    {"id":"11270","name":"Work programme until 2025 of the HMA/EMA task force on availability of authorised medicines for human and veterinary use","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2018-08-29T14:00:00Z","last_updated_date":"2023-05-17T15:35:00Z","reference_number":"EMA/724592/2022 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-until-2025-hmaema-task-force-availability-authorised-medicines-human-and-veterinary-use_en.pdf"},
    {"id":"11271","name":"CHMP post-authorisation summary of positive opinion for Pradaxa","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/CHMP/304146/2011  ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pradaxa_en.pdf-1"},
    {"id":"11272","name":"EU/3/10/815: Public summary of opinion on orphan designation: Sildenafil citrate for the treatment of postcardiotomy right ventricular failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/COMP/579361/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310815-public-summary-opinion-orphan-designation-sildenafil-citrate-treatment-postcardiotomy-right-ventricular-failure_en.pdf"},
    {"id":"11273","name":"Note for guidance on start of shelf-life of the finished dosage form\n\n(annex to note for guidance on the manufacture of the finished dosage form)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-05-31T02:00:00Z","last_updated_date":"2001-05-31T02:00:00Z","reference_number":"CPMP/QWP/072/96","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-start-shelf-life-finished-dosage-form-annex-note-guidance-manufacture-finished-dosage-form_en.pdf"},
    {"id":"11274","name":"Presentation - PRIME: Observations post-launch (Jordi Llinares, Zahra Hanaizi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prime-observations-post-launch-jordi-llinares-zahra-hanaizi_en.pdf"},
    {"id":"11275","name":"Presentation - Helping doctors and patients make sense of health statistics (Wolfgang Gaissmaier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-helping-doctors-and-patients-make-sense-health-statistics-wolfgang-gaissmaier_en.pdf"},
    {"id":"11278","name":"Mandate, objectives and rules of procedure for the CVMP Environmental Risk Assessment Working Party (ERAWP)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-12-22T01:00:00Z","last_updated_date":"2019-02-07T10:31:00Z","reference_number":"EMA/CVMP/ERA/705470/2009 - Rev.6","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-cvmp-environmental-risk-assessment-working-party-erawp_en.pdf"},
    {"id":"11279","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n16-19 July 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:09:21Z","last_updated_date":"2007-07-19T02:09:21Z","reference_number":"EMEA/431407/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-16-19-july-2007_en.pdf"},
    {"id":"11280","name":"Presentation - Preparing the CMC section of IMPD for biological/biotechnology derived substances (Una Moore)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-27T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preparing-cmc-section-impd-biologicalbiotechnology-derived-substances-una-moore_en.pdf"},
    {"id":"11282","name":"Withdrawal assessment report for Vynfinit","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-14T02:00:00Z","last_updated_date":"2014-08-14T02:00:00Z","reference_number":"EMA/CHMP/797690/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-vynfinit_en.pdf"},
    {"id":"11283","name":"Guidance on format of the risk-management plan in the European Union part II: Module SVIII - Summary of the safety concerns","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2013-08-21T02:00:00Z","reference_number":"EMA/465928/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-sviii-summary-safety-concerns_en.doc"},
    {"id":"11285","name":"Business Pipeline Activity - Enrico Tognana","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/business-pipeline-activity-enrico-tognana_en.pdf"},
    {"id":"11288","name":"EU/3/14/1244: Public summary of opinion on orphan designation: Ruxolitinib for the treatment of polycythaemia vera","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-02T18:00:00Z","last_updated_date":"2015-05-08T18:00:00Z","reference_number":"EMA/COMP/30457/2014 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141244-public-summary-opinion-orphan-designation-ruxolitinib-treatment-polycythaemia-vera_en.pdf"},
    {"id":"11289","name":"Modafinil-H-A-31-1186: Article 31 Referral-Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMA/4038/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/modafinil-h-31-1186-article-31-referral-assessment-report_en.pdf"},
    {"id":"11291","name":"Committee for veterinary medicinal products: 37th meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-11-12T12:09:21Z","last_updated_date":"1998-11-12T12:09:21Z","reference_number":"EMEA/CVMP/574/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-37th-meeting_en.pdf"},
    {"id":"11292","name":"Agenda - CAT agenda of the 16-17 April 2015 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-04-22T13:50:00Z","last_updated_date":"2015-04-22T13:50:00Z","reference_number":"EMA/CAT/258888/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-17-april-2015-meeting_en.pdf"},
    {"id":"11293","name":"Agenda – Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-03-02T11:00:00Z","last_updated_date":"2018-03-02T11:00:00Z","reference_number":"EMA/132201/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-industry-stakeholder-meeting-brexit-and-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"11294","name":"Agenda - Training session on the review of product information","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-11-22T01:00:00Z","last_updated_date":"2010-11-22T01:00:00Z","reference_number":"EMA/564815/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-review-product-information_en.pdf"},
    {"id":"11295","name":"European Medicines Agency concludes class review of bisphosphonates and atypical fractures","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/CHMP/292784/2011 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-class-review-bisphosphonates-and-atypical-fractures_en.pdf"},
    {"id":"11296","name":"COMP meeting report on the review of applications for orphan designation: February 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-02-20T17:05:00Z","last_updated_date":"2014-02-20T17:05:00Z","reference_number":"EMA/COMP/35549/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-february-2014_en.pdf"},
    {"id":"11297","name":"Commitee for Orphan Medicinal Products: November 2004 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-11-17T01:00:00Z","last_updated_date":"2004-11-17T01:00:00Z","reference_number":"EMEA/COMP/151881/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/commitee-orphan-medicinal-products-november-2004-meeting_en.pdf"},
    {"id":"11299","name":"Timeline: European Medicines Agency-FDA parallel scientific advice","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T16:30:00Z","last_updated_date":"2023-02-02T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/timeline-european-medicines-agency-fda-parallel-scientific-advice_en.pdf"},
    {"id":"11302","name":"Standard operating procedure for preparation and updates of European public assessment report summaries by Product-related Information to the Network Service","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2014-05-14T15:50:00Z","reference_number":"SOP/H/3131","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-and-updates-european-public-assessment-report-summaries-product-related-information-network-service_en.pdf"},
    {"id":"11305","name":"Submission of comments on 'European Network of Paediatric Research - Recognition criteria for self-assessment'","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-02-12T00:09:21Z","last_updated_date":"2010-02-12T00:09:21Z","reference_number":"EMA/89566/2010","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-european-network-paediatric-research-recognition-criteria-self-assessment_en.doc"},
    {"id":"11307","name":"Summary of transfers of appropriations in budgets 2017 and  2018","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2018-03-16T13:35:00Z","last_updated_date":"2018-03-16T13:35:00Z","reference_number":"EMA/MB/1127/2018 Noted","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfers-appropriations-budgets-2017-and-2018_en.pdf"},
    {"id":"11308","name":"Guidelines and concept papers adopted during the CHMP meeting 19-22 May 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-26T16:00:00Z","reference_number":"EMA/124022/2014","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-19-22-may-2014_en.pdf"},
    {"id":"11310","name":"CHMP summary of positive opinion for Temozolomide Hospira","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/810712/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-temozolomide-hospira_en.pdf"},
    {"id":"11313","name":"Lee Parker (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/lee-parker-doi_en.pdf"},
    {"id":"11314","name":"Renin-angiotensin-system (RAS)-acting agents Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T02:00:00Z","last_updated_date":"2013-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-notification_en.pdf"},
    {"id":"11315","name":"Questions and answers on Novantrone and associated names (mitoxantrone 2 mg/ml concentrate for solution for infusion)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/55368/2016 ","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-novantrone-and-associated-names-mitoxantrone-2-mgml-concentrate-solution-infusion_sv.pdf"}},
    {"id":"11317","name":"Final public statement on Glycine max (L.) Merr., semen - First version","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2018-07-31T02:00:00Z","last_updated_date":"2018-07-31T02:00:00Z","reference_number":"EMA/HMPC/461814/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-glycine-max-l-merr-semen-first-version_en.pdf"},
    {"id":"11320","name":"Acipimox only to be used as additional or alternative treatment to reduce high triglyceride levels","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/779546/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/acipimox-only-be-used-additional-or-alternative-treatment-reduce-high-triglyceride-levels_en.pdf"},
    {"id":"11321","name":"Presentation - ESVAC 2014 report. Interactive database (Kristine Ignate)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T17:00:00Z","last_updated_date":"2016-03-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-esvac-2014-report-interactive-database-kristine-ignate_en.pdf"},
    {"id":"11322","name":"PDCO work plan 2019","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2019-03-06T11:45:00Z","last_updated_date":"2019-03-06T11:45:00Z","reference_number":"EMA/PDCO/598684/2018","document_url":"https://www.ema.europa.eu/en/documents/work-programme/pdco-work-plan-2019_en.pdf"},
    {"id":"11324","name":"Withdrawal letter : NovoSeven","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-04-03T02:00:00Z","last_updated_date":"2006-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-novoseven_en.pdf"},
    {"id":"11326","name":"Final public statement on Withania somnifera (L.) Dunal, radix - First version","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/HMPC/681519/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-withania-somnifera-l-dunal-radix-first-version_en.pdf"},
    {"id":"11329","name":"CHMP post-authorisation summary of positive opinion for Ameluz","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/CHMP/813686/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ameluz_en.pdf"},
    {"id":"11331","name":"Committee for medicinal products for human use June 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-07-08T02:00:00Z","last_updated_date":"2005-07-08T02:00:00Z","reference_number":"EMEA/CHMP/207020/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-june-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"11333","name":"Presentation - Introduction of the PBPK Guideline and expectations of the day (Anna Nordmark)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-pbpk-guideline-and-expectations-day-anna-nordmark_en.pdf"},
    {"id":"11335","name":"(Co) Rapporteur (joint) assessment report of the grounds for the re-examination procedure - Rev. 05.21","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-07-03T16:30:00Z","last_updated_date":"2021-06-25T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/co-rapporteur-joint-assessment-report-grounds-re-examination-procedure-rev-0521_en.docx"},
    {"id":"11336","name":"Draft list of references supporting the assessment of Adhatoda vasica Nees, folium - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-01-24T01:00:00Z","last_updated_date":"2013-01-24T01:00:00Z","reference_number":"EMA/HMPC/681469/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-adhatoda-vasica-nees-folium-first-version_en.pdf"},
    {"id":"11337","name":"Pregnant mare serum gonadotrophin (PMSG): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/pregnant-mare-serum-gonadotrophin-pmsg-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11341","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Kalydeco (ivacaftor) for the treatment of cystic fibrosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-08-31T13:20:00Z","last_updated_date":"2022-08-10T10:33:00Z","reference_number":"EMA/COMP/394533/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-kalydeco-ivacaftor-treatment-cystic-fibrosis_en.pdf"},
    {"id":"11342","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Tygacil","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/245771/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tygacil_sv.pdf"}},
    {"id":"11344","name":"EU/3/13/1147: Public summary of opinion on orphan designation: Granulocyte-macrophage colony-stimulating factor for the treatment of pulmonary alveolar proteinosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2015-03-12T13:30:00Z","reference_number":"EMA/COMP/413549/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131147-public-summary-opinion-orphan-designation-granulocyte-macrophage-colony-stimulating-factor-treatment-pulmonary-alveolar-proteinosis_en.pdf"},
    {"id":"11346","name":"Presentation - Nanosystems in regenerative medicine, Jà¶ns Hilborn, Uppsala University","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nanosystems-regenerative-medicine-japns-hilborn-uppsala-university_en.pdf"},
    {"id":"11347","name":"Levomethadone: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/583/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/levomethadone-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11349","name":"Presentation - The European Medicines Agency geriatric medicines strategy report from the March 2012 workshop to the Healthcare Professionals' Working Group meeting","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-08-14T14:00:00Z","last_updated_date":"2012-08-14T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-geriatric-medicines-strategy-report-march-2012-workshop-healthcare-professionals-working-group-meeting_en.pdf"},
    {"id":"11351","name":"Presentation - The role of single arm trials in Oncology drug development(Gideon Blumenthal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T02:00:00Z","last_updated_date":"2016-08-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-single-arm-trials-oncology-drug-developmentgideon-blumenthal_en.pdf"},
    {"id":"11353","name":"La Jolla Limited withdraws its marketing authorisation application for Riquent","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-10-13T02:00:00Z","last_updated_date":"2006-10-13T02:00:00Z","reference_number":"EMEA/410861/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/la-jolla-limited-withdraws-its-marketing-authorisation-application-riquent_en.pdf"},
    {"id":"11356","name":"ICH guideline S10 on photosafety evaluation of pharmaceuticals - Step 5","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-01-31T18:30:00Z","last_updated_date":"2014-07-14T13:50:00Z","reference_number":"EMA/CHMP/ICH/752211/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ich-guideline-s10-photosafety-evaluation-pharmaceuticals-step-5_en.pdf"},
    {"id":"11358","name":"Standard Operating Procedure for Summary of the roles of the different parties in the event of a potential quality defect","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-02-09T01:00:00Z","last_updated_date":"2007-02-09T01:00:00Z","reference_number":"EMEA/INS/GMP/75467/2007","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-summary-roles-different-parties-event-potential-quality-defect_en.pdf"},
    {"id":"11361","name":"Questions and answers on the ongoing review of Gilenya (fingolimod)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-01-20T10:57:33Z","last_updated_date":"2012-01-20T10:57:33Z","reference_number":"EMA/43541/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-ongoing-review-gilenya-fingolimod_en.pdf"},
    {"id":"11364","name":"Superseded overview of comments received on 'Community herbal monograph on Cassia senna L. and Cassia angustifolia Vahl, folium' (EMEA/HMPC/51869/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2007-04-27T02:09:00Z","last_updated_date":"2007-04-27T02:09:00Z","reference_number":"EMEA/HMPC/237669/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-cassia-senna-l-and-cassia-angustifolia-vahl-folium-emeahmpc518692006_en.pdf"},
    {"id":"11365","name":"CHMP summary of positive opinion for Rasilez HCT","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2022-05-20T01:00:00Z","reference_number":"EMEA/CHMP/599453/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rasilez-hct_en.pdf"},
    {"id":"11366","name":"EMA reviewing cancer medicine docetaxel","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T13:00:00Z","last_updated_date":"2017-03-10T13:00:00Z","reference_number":"EMA/156136/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-reviewing-cancer-medicine-docetaxel_en.pdf"},
    {"id":"11369","name":"Agenda and registration form - EudraVigilance training on electronic reporting of Individual Case Study Reports (ICSRs) in the European Economic Area (Madrid, Sept 2016)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-08-19T02:00:00Z","last_updated_date":"2016-08-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-study-reports-icsrs-european-economic-area-madrid-sept-2016_en.pdf"},
    {"id":"11371","name":"Presentation - Paediatrics: Paediatric investigation plan: National agency assessor’s point of view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatrics-paediatric-investigation-plan-national-agency-assessors-point-view_en.pdf"},
    {"id":"11372","name":"Carbetocin: List of nationally authorised medicinal products - PSUSA/00000546/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T12:06:00Z","last_updated_date":"2018-03-09T12:09:09Z","reference_number":"EMA/154294/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/carbetocin-list-nationally-authorised-medicinal-products-psusa00000546201706_en.pdf"},
    {"id":"11374","name":"Presentation - How could social media data be relevant to regulatory decision-making? (June M Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-could-social-media-data-be-relevant-regulatory-decision-making-june-m-raine_en.pdf"},
    {"id":"11375","name":"Implementation on the Paediatric regulation EMEA views - Nathalie Seigneuret","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/implementation-paediatric-regulation-emea-views-nathalie-seigneuret_en.pdf"},
    {"id":"11376","name":"Valproate and related substances Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-and-related-substances-article-31-referral-notification_en.pdf"},
    {"id":"11380","name":"Compilation of individual product-specific guidance on demonstration of bioequivalence (Revision 3)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T18:00:00Z","last_updated_date":"2016-04-07T18:00:00Z","reference_number":"EMA/CHMP/736403/2014 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/compilation-individual-product-specific-guidance-demonstration-bioequivalence-revision-3_en.pdf"},
    {"id":"11381","name":"Overview of comments received on 'Guideline on Clinical Investigation of Medicinal Products in the treatment of epileptic disorders' (CHMP/EWP/566/98 Rev.2) - Revision 2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/611366/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-epileptic-disorders-chmpewp56698-rev2-revision-2_en.pdf"},
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    {"id":"11385","name":"Enrofloxacin Article-35 referral - Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and 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    {"id":"11386","name":"Presentation - Family involvement in research projects: a parental perspective (Silke Mader)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-family-involvement-research-projects-parental-perspective-silke-mader_en.pdf"},
    {"id":"11389","name":"Template for comments to answer to Questions 3 and 4 - Public consultation regarding the request to the European Medicines Agency from the European Commission for scientific advice on the impact on public health and anim...","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T16:15:00Z","last_updated_date":"2013-12-17T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-comments-answer-questions-3-and-4-public-consultation-regarding-request-european-medicines-agency-european-commission-scientific-advice-impact-public-health-and-anim_en.doc"},
    {"id":"11390","name":"Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (Priya Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T17:30:00Z","last_updated_date":"2017-03-30T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-european-union-eu-gvp-priya-bahri_en.pdf-0"},
    {"id":"11392","name":"Questions and answers on the shortages of Cerezyme and Fabrazyme","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2009-06-25T02:09:21Z","reference_number":"EMEA/388773/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-shortages-cerezyme-and-fabrazyme_en.pdf"},
    {"id":"11393","name":"CHMP post-authorisation summary of positive opinion for Kalydeco","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/619312/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kalydeco_en.pdf-0"},
    {"id":"11394","name":"PDCO meeting highlights 22-24 July 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-31T02:00:00Z","last_updated_date":"2009-07-31T02:00:00Z","reference_number":"EMEA/PDCO/449592/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-22-24-july-2009_en.pdf"},
    {"id":"11395","name":"Minutes of the European network of paediatric research at the European Medicines Agency coordinating group teleconference - 21 January 2015","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-03-09T16:00:00Z","last_updated_date":"2015-03-09T16:00:00Z","reference_number":"EMA/52510/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-agency-coordinating-group-teleconference-21-january-2015_en.pdf"},
    {"id":"11396","name":"Evicel: Product information as approved by the CHMP on 15 November 2012, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T12:54:00Z","last_updated_date":"2012-11-23T12:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/evicel-product-information-approved-chmp-15-november-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"11397","name":"CHMP summary of positive opinion for Aimovig","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/CHMP/283640/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aimovig_en.pdf"},
    {"id":"11400","name":"Pharmacogenomic markers in EGFR-targeted therapy of lung cancer - Rafal Dziadziuszko","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/pharmacogenomic-markers-egfr-targeted-therapy-lung-cancer-rafal-dziadziuszko_en.pdf"},
    {"id":"11401","name":"Final assessment report on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-09-10T02:00:00Z","last_updated_date":"2014-09-10T02:00:00Z","reference_number":"EMA/HMPC/137298/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-rosa-gallica-l-rosa-centifolia-l-rosa-damascena-mill-flos_en.pdf"},
    {"id":"11402","name":"Overview of comments received on Community herbal monograph on Cinnamomum verum J. S. Presl, cortex (EMA/HMPC/246774/2009)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2011-08-05T02:00:00Z","reference_number":"EMA/HMPC/31666/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-cinnamomum-verum-j-s-presl-cortex-emahmpc2467742009_en.pdf"},
    {"id":"11406","name":"Ruscus aculeatus: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/569/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ruscus-aculeatus-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11407","name":"EU/3/14/1316: Public summary of opinion on orphan designation: Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2014-10-01T02:00:00Z","reference_number":"EMA/COMP/434800/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141316-public-summary-opinion-orphan-designation-recombinant-factor-viia-modified-three-terminal-repeats-derived-i2-chain-human-chorionic-gonadotropin-treatment-haemophilia_en.pdf"},
    {"id":"11409","name":"Tredaptive, Pelzont and Trevaclyn Article-20 procedure - European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-01-18T01:00:00Z","reference_number":"EMA/CHMP/21862/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/tredaptive-pelzont-and-trevaclyn-article-20-procedure-european-medicines-agency-confirms-recommendation-suspend-tredaptive-pelzont-and-trevaclyn_en.pdf"},
    {"id":"11412","name":"Initial notices for parallel distribution - 2008","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-06-18T02:00:00Z","last_updated_date":"2009-06-18T02:00:00Z","reference_number":"EMEA/383030/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2008_en.pdf"},
    {"id":"11416","name":"EU/3/16/1682: Public summary of opinion on orphan designation: Melatonin for the treatment of necrotising enterocolitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-08-02T17:30:00Z","last_updated_date":"2016-08-02T17:30:00Z","reference_number":"EMA/COMP/391425/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161682-public-summary-opinion-orphan-designation-melatonin-treatment-necrotising-enterocolitis_en.pdf"},
    {"id":"11418","name":"Standard Operating Procedure for SIAMED-related data validation of new veterinary centralised procedures","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-02-16T01:00:00Z","last_updated_date":"2010-04-27T02:00:00Z","reference_number":"SOP/V/4033","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-siamed-related-data-validation-new-veterinary-centralised-procedures_en.pdf"},
    {"id":"11420","name":"CHMP post-authorisation summary of positive opinion for Soliris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T13:00:00Z","last_updated_date":"2013-03-22T13:00:00Z","reference_number":"EMA/CHMP/179438/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-soliris_en.pdf-0"},
    {"id":"11421","name":"CHMP ORGAM agenda for the meeting on 30 October 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-11-28T13:00:00Z","last_updated_date":"2017-11-28T13:00:00Z","reference_number":"EMA/720087/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-30-october-2017_en.pdf"},
    {"id":"11424","name":"Denaverine hydrochloride: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-12-01T01:00:00Z","last_updated_date":"1997-12-01T01:00:00Z","reference_number":"EMEA/MRL/307/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/denaverine-hydrochloride-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11425","name":"Presentation - Innovation in medicines and manufacturing (David Tainsh, Keith Pugh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-innovation-medicines-and-manufacturing-david-tainsh-keith-pugh_en.pdf"},
    {"id":"11426","name":"Presentation - How can summary-of-product-characteristics and European-public-assessment-report information contribute to the safe and effective use of medicines in the older population?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-can-summary-product-characteristics-and-european-public-assessment-report-information-contribute-safe-and-effective-use-medicines-older-population_en.pdf"},
    {"id":"11428","name":"Targanta Netherlands B.V. withdraws its marketing authorisation application for Ramvocid (oritavancin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-08-24T02:00:00Z","last_updated_date":"2009-08-24T02:00:00Z","reference_number":"EMEA/535907/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/targanta-netherlands-bv-withdraws-its-marketing-authorisation-application-ramvocid-oritavancin_en.pdf"},
    {"id":"11429","name":"Presentation - CT design - combinations (Samir Khleif) - S5.3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ct-design-combinations-samir-khleif-s53_en.pdf"},
    {"id":"11431","name":"Presentation - Adverse drug reactions in paediatric oncology (Ralf Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adverse-drug-reactions-paediatric-oncology-ralf-herold_en.pdf"},
    {"id":"11432","name":"Explanatory note on fees payable to the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-22T13:15:00Z","last_updated_date":"2011-12-22T13:15:00Z","reference_number":"EMA/283580/2011","document_url":"https://www.ema.europa.eu/en/documents/other/explanatory-note-fees-payable-european-medicines-agency_en.pdf"},
    {"id":"11433","name":"Presentation - CAT feedback (Kieran Breen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cat-feedback-kieran-breen-ema_en.pdf"},
    {"id":"11434","name":"Draft guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-06-18T02:00:00Z","last_updated_date":"2007-06-18T02:00:00Z","reference_number":"CVMP/328/98-Revision 3-CONS","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-acceptability-names-veterinary-medicinal-products-processed-through-centralised-procedure_en.pdf"},
    {"id":"11435","name":"Overview of Comments received on Public Statement on the use of herbal medicinal products containing estragole and on Public Statement on the use of herbal medicinal products containing methyleugenol","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-11-23T01:00:00Z","last_updated_date":"2005-11-23T01:00:00Z","reference_number":"EMEA/381090/2005","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-public-statement-use-herbal-medicinal-products-containing-estragole-and-public-statement-use-herbal-medicinal-products-containing-methyleugenol_en.pdf"},
    {"id":"11436","name":"EU/3/16/1765: Public summary of positive opinion for orphan designation of ubiquinol for the treatment of primary coenzyme Q10 deficiency syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/620954/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161765-public-summary-positive-opinion-orphan-designation-ubiquinol-treatment-primary-coenzyme-q10-deficiency-syndrome_en.pdf"},
    {"id":"11437","name":"Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-05-13T12:30:00Z","last_updated_date":"2013-05-13T12:30:00Z","reference_number":"EMA/HMPC/71049/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"11439","name":"Working party on Herbal Medicinal Products: Final concept paper on the implementation of different levels of scientific evidence in core-data for herbal drugs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-03-03T01:00:00Z","last_updated_date":"2004-03-03T01:00:00Z","reference_number":"EMEA/CPMP/HMPWP/1156/03","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-final-concept-paper-implementation-different-levels-scientific-evidence-core-data-herbal-drugs_en.pdf"},
    {"id":"11440","name":"CHMP post-authorisation summary of positive opinion for Orencia","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T14:00:00Z","last_updated_date":"2017-06-23T14:00:00Z","reference_number":"EMA/CHMP/368672/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-orencia_en.pdf-0"},
    {"id":"11441","name":"Presentation - Update on Enpr-EMA activities, achievements and challenges","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-enpr-ema-activities-achievements-and-challenges_en.pdf"},
    {"id":"11444","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic bone-marrow derived osteoblastic cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-08-12T15:37:46Z","last_updated_date":"2011-08-12T15:37:46Z","reference_number":"EMA/CAT/647468/2011","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-bone-marrow-derived-osteoblastic-cells_en.pdf"},
    {"id":"11445","name":"Work instructions for publication of the monthly and annual overview of parallel distribution notices issued by the European Medicines Agency","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-07-20T02:00:00Z","last_updated_date":"2012-07-11T17:30:02Z","reference_number":"WIN/H/2037","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-publication-monthly-and-annual-overview-parallel-distribution-notices-issued-european-medicines-agency_en.pdf"},
    {"id":"11446","name":"Template to report an allegation concerning an impropriety in an area of EMA’s responsibility (authorisation, supervision and maintenance of human and veterinary medicinal products)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-11-28T18:21:00Z","last_updated_date":"2020-01-10T09:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-report-allegation-concerning-impropriety-area-emas-responsibility-authorisation-supervision-and-maintenance-human-and-veterinary-medicinal-products_en.doc"},
    {"id":"11447","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 11-12 July 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-07-25T18:20:00Z","last_updated_date":"2016-07-25T18:20:00Z","reference_number":"EMA/HMPC/489336/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-11-12-july-2016_en.pdf"},
    {"id":"11450","name":"Presentation - Online reporting for patients and healthcare professionals: a practical example (Phil Tregunno)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-online-reporting-patients-and-healthcare-professionals-practical-example-phil-tregunno_en.pdf"},
    {"id":"11451","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n15-18 October 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-10-18T02:09:21Z","last_updated_date":"2007-10-18T02:09:21Z","reference_number":"EMEA/479200/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-15-18-october-2007_en.pdf"},
    {"id":"11453","name":"Presentation - Agenda point 5: Consideration on the ESVAC project from  the Federation of Veterinarians of Europe (FVE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-point-5-consideration-esvac-project-federation-veterinarians-europe-fve_en.pdf"},
    {"id":"11455","name":"Nasonex Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-02-03T10:40:00Z","last_updated_date":"2015-02-03T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nasonex-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nasonex-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nasonex-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nasonex-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nasonex-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nasonex-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nasonex-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nasonex-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nasonex-article-30-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nasonex-article-30-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nasonex-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nasonex-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nasonex-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nasonex-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nasonex-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nasonex-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nasonex-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nasonex-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nasonex-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nasonex-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nasonex-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nasonex-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nasonex-article-30-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/nasonex-article-30-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/nasonex-article-30-referral-annex-i_no.pdf"}},
    {"id":"11456","name":"Ancillary - Day 150 JAR Quality template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:25:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-150-jar-quality-template-rev1016_en.doc"},
    {"id":"11457","name":"Public statement on Nyracta (rosiglitazone): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-04-18T14:09:21Z","last_updated_date":"2005-04-18T14:09:21Z","reference_number":"EMEA/41043/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-nyracta-rosiglitazone-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"11458","name":"Presentation - Specific methodological issues and implications for risk assessment, Silvia Berkner, German Federal Environmental Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-specific-methodological-issues-and-implications-risk-assessment-silvia-berkner-german-federal-environmental-agency_en.pdf"},
    {"id":"11460","name":"Assessment report for ergot derivatives containing medicinal products - dihydroergocristine","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"EMA/750624/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-ergot-derivatives-containing-medicinal-products-dihydroergocristine_en.pdf"},
    {"id":"11461","name":"Presentation -  Payer opinions in context (Ad Schuurman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-payer-opinions-context-ad-schuurman_en.pdf"},
    {"id":"11463","name":"Standard operating procedure for referral procedures in accordance with the provisions of Articles 33(4), 34 and 35 of Directive 2001/82/EC, and Article 13 of Commission Regulation (EC) No 1234/2008, related to veterinar...","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-04-15T02:00:00Z","last_updated_date":"2016-01-14T19:00:00Z","reference_number":"SOP/V/4024","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-referral-procedures-accordance-provisions-articles-334-34-and-35-directive-200182ec-and-article-13-commission-regulation-ec-no-12342008-related-veterinar_en.pdf"},
    {"id":"11468","name":"EU/3/02/101: Public summary of positive opinion for orphan designation of pseudomonas exotoxin (domains II/III)-interleukin 13 chimeric protein for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T00:00:00Z","last_updated_date":"2016-10-20T14:00:00Z","reference_number":"EMEA/COMP/612/02 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302101-public-summary-positive-opinion-orphan-designation-pseudomonas-exotoxin-domains-iiiii-interleukin-13-chimeric-protein-treatment-glioma_en.pdf"},
    {"id":"11469","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2012-02-17T01:00:00Z","reference_number":"EMA/CHMP/120503/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-0"},
    {"id":"11470","name":"CHMP post-authorisation summary of positive opinion for Adcetris (II-48)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"EMA/CHMP/706305/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adcetris-ii-48_en.pdf"},
    {"id":"11473","name":"Overview of comments received on European Union herbal monograph and European Union list entry on Crataegus spp., folium cum flore","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/HMPC/150876/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-and-european-union-list-entry-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"11474","name":"Draft minutes of the focus group meeting on Pharmacokinetic / Pharmacodynamic (PK/PD) modelling in veterinary medicines","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2008-09-24T02:09:21Z","last_updated_date":"2008-09-24T02:09:21Z","reference_number":"EMEA/CVMP/EWP/503528/2008","document_url":"https://www.ema.europa.eu/en/documents/minutes/draft-minutes-focus-group-meeting-pharmacokinetic-pharmacodynamic-pkpd-modelling-veterinary-medicines_en.pdf"},
    {"id":"11476","name":"Presentation - Overview of one-year experience of PRIME eligibility assessment (Robert Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-07T02:00:00Z","last_updated_date":"2017-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-one-year-experience-prime-eligibility-assessment-robert-hemmings_en.pdf"},
    {"id":"11477","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): GVP - Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-12T11:00:00Z","last_updated_date":"2013-12-12T11:00:00Z","reference_number":"EMA/756032/2013","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-product-or-population-specific-considerations-i-vaccines-prophylaxis-against-infectious-diseases_en.pdf"},
    {"id":"11479","name":"Shaping the future of human and animal health in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/821169/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/shaping-future-human-and-animal-health-eu_en.pdf"},
    {"id":"11481","name":"Difloxacin (Extension to all food producing species): Summary report (5) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/MRL/819/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/difloxacin-extension-all-food-producing-species-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11482","name":"CVMP summary of positive opinion for Versican Plus Pi/L4","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/CVMP/301775/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-versican-plus-pil4_en.pdf"},
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    {"id":"11486","name":"Annex 02  Response Questionnaire - EMA-2012-09-IF","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"EMA/687077/2011","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-02-response-questionnaire-ema-2012-09-if_en.xls"},
    {"id":"11487","name":"Doramectin (Extension to deer): Summary report (5) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-01-01T01:00:00Z","last_updated_date":"2001-01-01T01:00:00Z","reference_number":"EMEA/MRL/773/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/doramectin-extension-deer-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11488","name":"Presentation - Encouraging prudent use of antibiotics (V. J. Chave)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-encouraging-prudent-use-antibiotics-v-j-chave_en.pdf"},
    {"id":"11489","name":"Presentation - Procedure for election of PCWP-HCPWP co-chairs 2016-2019","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedure-election-pcwp-hcpwp-co-chairs-2016-2019_en.pdf"},
    {"id":"11490","name":"CHMP summary of positive opinion for Entacapone Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-11-26T01:00:00Z","last_updated_date":"2010-11-26T01:00:00Z","reference_number":"EMA/CHMP/659548/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-entacapone-teva_en.pdf"},
    {"id":"11493","name":"Draft note for guidance on antiarrhytmics addendum on atrial fibrillation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/352438/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-note-guidance-antiarrhytmics-addendum-atrial-fibrillation_en.pdf"},
    {"id":"11494","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 May 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-05-15T14:00:00Z","last_updated_date":"2017-05-15T14:00:00Z","reference_number":"EMA/CVMP/268972/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-may-2017_en.pdf"},
    {"id":"11495","name":"Divergent position on a revised CVMP opinion on an Article-33(4) referral of Directive 2001/82/EC for Nuflor Swine Once 450-mg/ml solution for injection","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-revised-cvmp-opinion-article-334-referral-directive-200182ec-nuflor-swine-once-450-mgml-solution-injection_en.pdf"},
    {"id":"11499","name":"Biomarkers in the new European regulatory environment - Bruno Flamion","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-12-16T00:09:21Z","last_updated_date":"2005-12-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/biomarkers-new-european-regulatory-environment-bruno-flamion_en.pdf"},
    {"id":"11500","name":"Presentation - Communication campaign: medicines under additional monitoring (Christopher Gadd)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-campaign-medicines-under-additional-monitoring-christopher-gadd_en.pdf"},
    {"id":"11501","name":"Workshop on the development of an EMEA transparency policy - Draft key principles","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/workshop-development-emea-transparency-policy-draft-key-principles_en.pdf"},
    {"id":"11502","name":"Presentation - Early interactions on innovation at EMA (ITF) (Falk Ehmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-interactions-innovation-ema-itf-falk-ehmann_en.pdf"},
    {"id":"11503","name":"EU/3/15/1487: Public summary of opinion on orphan designation: Reduced oxidised N-acetyl heparin for the treatment of plasma cell myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2021-09-02T02:00:00Z","reference_number":"EMA/COMP/281341/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151487-public-summary-opinion-orphan-designation-reduced-oxidised-n-acetyl-heparin-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"11504","name":"Declaration of interests - Christiane de Boeck","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-christiane-de-boeck_en.pdf"},
    {"id":"11505","name":"CVMP Public Statement on CPMP Public Statement on Lactose prepared using Calf Rennet: Risk Assessment in relation to bovine spongiform encephalophaties (BSE)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-05-06T02:09:21Z","last_updated_date":"2002-05-06T02:09:21Z","reference_number":"EMEA/CVMP/556/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/cvmp-public-statement-cpmp-public-statement-lactose-prepared-using-calf-rennet-risk-assessment-relation-bovine-spongiform-encephalophaties-bse_en.pdf"},
    {"id":"11508","name":"CHMP summary of positive opinion for Ucedane","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/CHMP/253159/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ucedane_en.pdf"},
    {"id":"11509","name":"Scientific recommendation on classification of advanced therapy medicinal products: Suspension of live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin for intravenous infusion","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T12:45:00Z","last_updated_date":"2016-04-12T12:45:00Z","reference_number":"EMA/213686/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-suspension-live-attenuated-double-deleted-listeria-monocytogenes-expressing-human-mesothelin-intravenous-infusion_en.pdf"},
    {"id":"11511","name":"Clobutinol - Article 107 procedures - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-10-19T02:08:21Z","last_updated_date":"2007-10-19T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/clobutinol-article-107-procedures-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/clobutinol-article-107-procedures-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/clobutinol-article-107-procedures-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/clobutinol-article-107-procedures-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/clobutinol-article-107-procedures-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/clobutinol-article-107-procedures-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/clobutinol-article-107-procedures-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/clobutinol-article-107-procedures-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/clobutinol-article-107-procedures-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/clobutinol-article-107-procedures-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/clobutinol-article-107-procedures-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/clobutinol-article-107-procedures-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/clobutinol-article-107-procedures-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/clobutinol-article-107-procedures-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/clobutinol-article-107-procedures-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/clobutinol-article-107-procedures-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/clobutinol-article-107-procedures-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/clobutinol-article-107-procedures-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/clobutinol-article-107-procedures-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/clobutinol-article-107-procedures-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/clobutinol-article-107-procedures-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/clobutinol-article-107-procedures-annex-i_sv.pdf"}},
    {"id":"11512","name":"EU/3/14/1299: Public summary of opinion on orphan designation: Riociguat for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T17:30:00Z","last_updated_date":"2014-09-01T17:30:00Z","reference_number":"EMA/COMP/359772/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141299-public-summary-opinion-orphan-designation-riociguat-treatment-systemic-sclerosis_en.pdf"},
    {"id":"11514","name":"Presentation - General considerations from industry - Session 3 (Ron Ogilvie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-considerations-industry-session-3-ron-ogilvie_en.pdf"},
    {"id":"11515","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Hetlioz (tasimelteon) for the treatment of non-24-hour sleep-wake disorder","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T15:22:00Z","last_updated_date":"2015-07-27T15:22:00Z","reference_number":"EMA/COMP/321004/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-hetlioz-tasimelteon-treatment-non-24-hour-sleep-wake-disorder_en.pdf"},
    {"id":"11516","name":"CHMP summary of positive opinion for Victrelis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2018-07-31T02:00:00Z","reference_number":"EMA/CHMP/354114/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-victrelis_en.pdf"},
    {"id":"11523","name":"Potassium aspartate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-07-01T02:00:00Z","last_updated_date":"1997-07-01T02:00:00Z","reference_number":"EMEA/MRL/240/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/potassium-aspartate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11525","name":"Minutes of the European network of paediatric research-European Medicines working groups meeting 23 January 2014","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T16:00:00Z","last_updated_date":"2014-03-21T16:00:00Z","reference_number":"EMA/126483/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-working-groups-meeting-23-january-2014_en.pdf"},
    {"id":"11528","name":"PDCO meeting report 10-12 August 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-08-19T02:00:00Z","last_updated_date":"2011-08-19T02:00:00Z","reference_number":"EMA/PDCO/626428/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-10-12-august-2011_en.pdf"},
    {"id":"11529","name":"EU/3/04/238: Public summary of positive opinion for orphan designation of recombinant human insulin-like growth factor-I/recombinant human insulin-like growth factor binding protein-3 for the treatment of leprechaunism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-20T00:00:00Z","last_updated_date":"2011-06-22T01:00:00Z","reference_number":"EMEA/COMP/77797/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304238-public-summary-positive-opinion-orphan-designation-recombinant-human-insulin-growth-factor-irecombinant-human-insulin-growth-factor-binding-protein-3-treatment-leprechaunism_en.pdf"},
    {"id":"11531","name":"2011 EudraVigilance Human annual report","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-06-19T11:30:00Z","last_updated_date":"2013-06-19T11:30:00Z","reference_number":"EMA/733372/2012","document_url":"https://www.ema.europa.eu/en/documents/report/2011-eudravigilance-human-annual-report_en.pdf"},
    {"id":"11532","name":"Presentation - Digital Media and Health Topic Group - EMA's PCWP and HCPWP joint meeting (Kathi Apostolidis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-digital-media-and-health-topic-group-emas-pcwp-and-hcpwp-joint-meeting-kathi-apostolidis_en.pdf"},
    {"id":"11534","name":"Presentation - Pharmacovigilance Working Party: Patients' and consumers' experience","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-working-party-patients-and-consumers-experience_en.pdf"},
    {"id":"11535","name":"Overview of comments received on HMPC draft procedure for calls for scientific data for use in HMPC assessment work (EMEA/HMPC/1004/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2006-10-26T02:09:21Z","last_updated_date":"2006-10-26T02:09:21Z","reference_number":"EMEA/HMPC/309487/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-hmpc-draft-procedure-calls-scientific-data-use-hmpc-assessment-work-emeahmpc10042006_en.pdf"},
    {"id":"11538","name":"EU/3/17/1836: Public summary of opinion on orphan designation: Fenfluramine hydrochloride for the treatment of Lennox-Gastaut syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/71973/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171836-public-summary-opinion-orphan-designation-fenfluramine-hydrochloride-treatment-lennox-gastaut-syndrome_en.pdf"},
    {"id":"11539","name":"Presentation - Spontaneous reporting: detecting medication errors and suitability of current systems (Phil Tregunno)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spontaneous-reporting-detecting-medication-errors-and-suitability-current-systems-phil-tregunno_en.pdf"},
    {"id":"11541","name":"Guideline on the evaluation of control samples in nonclinical safety studies:  checking for contamination with the test substance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-03-17T01:00:00Z","last_updated_date":"2005-03-17T01:00:00Z","reference_number":"CPMP/SWP/1094/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-control-samples-nonclinical-safety-studies-checking-contamination-test-substance_en.pdf"},
    {"id":"11542","name":"Almitrine Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T02:00:00Z","last_updated_date":"2013-12-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/almitrine-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/almitrine-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/almitrine-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/almitrine-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/almitrine-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/almitrine-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/almitrine-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/almitrine-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/almitrine-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/almitrine-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/almitrine-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/almitrine-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/almitrine-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/almitrine-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/almitrine-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/almitrine-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/almitrine-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/almitrine-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/almitrine-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/almitrine-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/almitrine-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/almitrine-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"11544","name":"CHMP post-authorisation summary of positive opinion for Xarelto (II-58)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/515065/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xarelto-ii-58_en.pdf"},
    {"id":"11547","name":"Registration form: Second Veterinary E-Submission Workshop","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-11-18T00:09:21Z","last_updated_date":"2009-11-18T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-second-veterinary-e-submission-workshop_en.pdf"},
    {"id":"11549","name":"Committee for medicinal products for human use, summary of positive opinion for Vidaza","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-10-24T02:00:00Z","last_updated_date":"2008-10-24T02:00:00Z","reference_number":"EMEA/CHMP/528772/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-vidaza_en.pdf"},
    {"id":"11550","name":"Work plan for the Good Clinical Practice Inspectors Working Group for 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T11:38:00Z","last_updated_date":"2012-02-20T11:38:00Z","reference_number":"EMA/INS/GCP/920415/2011","document_url":"https://www.ema.europa.eu/en/documents/other/work-plan-good-clinical-practice-inspectors-working-group-2012_en.pdf"},
    {"id":"11553","name":"Meeting requirements for clinical trials and marketing authorisation reprotoxicity - Peter Kasper","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/meeting-requirements-clinical-trials-and-marketing-authorisation-reprotoxicity-peter-kasper_en.pdf"},
    {"id":"11554","name":"ECDC/EFSA/EMA first joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals - Joint interagency ant...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-01-30T01:00:00Z","last_updated_date":"2015-01-30T01:00:00Z","reference_number":"636088/2013","document_url":"https://www.ema.europa.eu/en/documents/report/ecdcefsaema-first-joint-report-integrated-analysis-consumption-antimicrobial-agents-and-occurrence-antimicrobial-resistance-bacteria-humans-and-food-producing-animals-joint-interagency-ant_en.pdf"},
    {"id":"11555","name":"Declaration of research interests (addendum) - Anne Junker","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-research-interests-addendum-anne-junker_en.pdf"},
    {"id":"11556","name":"Superseded Community herbal monograph on Salvia officinalis L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2017-07-13T02:00:00Z","reference_number":"EMA/HMPC/331653/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-salvia-officinalis-l-folium_en.pdf"},
    {"id":"11557","name":"Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-15T12:35:00Z","last_updated_date":"2017-06-15T12:35:00Z","reference_number":"EMA/381816/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ambroxol-list-nationally-authorised-medicinal-products-psusa00000130201609_en.pdf"},
    {"id":"11558","name":"Paediatric Project / Development Planning 'Key Points to Consider' - Angelika Joos","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/paediatric-project-development-planning-key-points-consider-angelika-joos_en.pdf"},
    {"id":"11559","name":"GVK Biosciences Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T02:00:00Z","last_updated_date":"2015-08-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gvk-biosciences-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gvk-biosciences-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gvk-biosciences-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gvk-biosciences-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gvk-biosciences-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gvk-biosciences-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gvk-biosciences-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gvk-biosciences-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gvk-biosciences-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gvk-biosciences-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gvk-biosciences-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gvk-biosciences-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gvk-biosciences-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gvk-biosciences-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gvk-biosciences-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gvk-biosciences-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gvk-biosciences-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gvk-biosciences-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gvk-biosciences-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gvk-biosciences-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gvk-biosciences-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gvk-biosciences-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"11565","name":"Information Management Strategy 2019-2021","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2019-03-08T12:29:00Z","reference_number":"EMA/502708/2018","document_url":"https://www.ema.europa.eu/en/documents/other/information-management-strategy-2019-2021_en.pdf"},
    {"id":"11566","name":"Cad a chiallaà­onn an triantà¡n dubh?","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-01T02:00:00Z","last_updated_date":"2013-10-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cad-chiallaa-onn-triantan-dubh_en.pdf"},
    {"id":"11567","name":"Break-out session 4 report - Modelling and simulation to optimise the design of confirmatory trials, to analyse phase 3 data and to characterise risk-benefit and support label claims","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-05-08T11:30:00Z","last_updated_date":"2012-05-08T11:30:00Z","reference_number":"EMA/143476/2012","document_url":"https://www.ema.europa.eu/en/documents/report/break-out-session-4-report-modelling-and-simulation-optimise-design-confirmatory-trials-analyse-phase-3-data-and-characterise-risk-benefit-and-support-label-claims_en.pdf"},
    {"id":"11569","name":"Levamisole: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/levamisole-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"11570","name":"EU/3/17/1897: Public summary of opinion on orphan designation: Tirapazamine for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-14T16:54:00Z","last_updated_date":"2017-08-14T16:54:00Z","reference_number":"EMA/410458/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171897-public-summary-opinion-orphan-designation-tirapazamine-treatment-hepatocellular-carcinoma_en.pdf"},
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    {"id":"11572","name":"Hydromorphone: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"11579","name":"Superseded opinion of the HMPC on a community herbal monograph on Tanacetum parthenium (L.) Shulz Bip., herba - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-06-20T02:00:00Z","last_updated_date":"2020-08-14T02:00:00Z","reference_number":"EMA/HMPC/757136/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-tanacetum-parthenium-l-shulz-bip-herba-first-version_en.pdf"},
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    {"id":"11588","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 20-22 July 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-08-04T12:35:00Z","last_updated_date":"2016-08-04T12:35:00Z","reference_number":"EMA/PDCO/510975/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-20-22-july-2016_en.pdf"},
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    {"id":"11594","name":"Overview of comments received on 'Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T16:49:00Z","last_updated_date":"2016-02-15T16:49:00Z","reference_number":"EMA/480192/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-use-minimal-residue-disease-endpoint-chronic-lymphocytic-leukaemia-studies_en.pdf"},
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    {"id":"11596","name":"PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2014-10-10T02:00:00Z","reference_number":"EMA/615086/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-further-measures-minimise-risk-blood-vessel-blockage-iclusig_en.pdf"},
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    {"id":"11598","name":"Agenda and registration form - Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area (Paris)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-09-21T02:00:00Z","last_updated_date":"2016-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-training-electronic-reporting-individual-case-safety-reports-icsrs-eudravigilance-european-economic-area-paris_en.pdf"},
    {"id":"11601","name":"Presentation - Cardiology network (Sylvie di Filippo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cardiology-network-sylvie-di-filippo_en.pdf"},
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    {"id":"11603","name":"Guidelines and concept papers adopted during the CHMP meeting 12-15 December 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-16T13:00:00Z","last_updated_date":"2011-12-16T13:00:00Z","reference_number":"EMA/CHMP/941885/2011","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-12-15-december-2011_en.pdf"},
    {"id":"11604","name":"Stem cell-based medicinal products as ATMPs in the EU: Dr Tiina Palomà¤ki","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/stem-cell-based-medicinal-products-atmps-eu-dr-tiina-palomaki_en.pdf"},
    {"id":"11610","name":"Guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-12-19T13:00:00Z","last_updated_date":"2016-12-19T13:00:00Z","reference_number":"EMA/CVMP/IWP/206555/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-production-and-control-immunological-veterinary-medicinal-products-revision-1_en.pdf"},
    {"id":"11611","name":"Clenil Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-11-18T01:00:00Z","last_updated_date":"2016-11-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/clenil-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/clenil-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/clenil-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/clenil-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/clenil-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/clenil-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/clenil-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/clenil-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/clenil-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/clenil-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/clenil-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/clenil-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/clenil-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/clenil-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/clenil-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/clenil-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/clenil-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/clenil-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/clenil-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/clenil-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/clenil-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/clenil-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/clenil-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"11613","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 September 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-09-12T02:00:00Z","last_updated_date":"2014-09-12T02:00:00Z","reference_number":"EMA/CVMP/534989/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-september-2014_en.pdf"},
    {"id":"11615","name":"Good Laboratory Practice (GLP) principles in relation to advanced therapy medicinal products (ATMPs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-07-11T13:45:00Z","last_updated_date":"2017-07-11T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/good-laboratory-practice-glp-principles-relation-advanced-therapy-medicinal-products-atmps_en.pdf"},
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    {"id":"11620","name":"EU/3/05/339: Public summary of positive opinion for orphan designation of dasatinib for the treatment of chronic myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:00:00Z","last_updated_date":"2017-02-09T00:00:00Z","reference_number":"EMEA/COMP/386800/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305339-public-summary-positive-opinion-orphan-designation-dasatinib-treatment-chronic-myeloid-leukaemia_en.pdf"},
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    {"id":"11622","name":"EU/3/10/829: Public summary of opinion on orphan designation: Tesetaxel for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"EMA/COMP/671327/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310829-public-summary-opinion-orphan-designation-tesetaxel-treatment-gastric-cancer_en.pdf"},
    {"id":"11623","name":"Micro Therapeutic Research Article-31 referral - CHMP list of questions to be addressed by the applicants/marketing authorisation holders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"EMA/CHMP/847556/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-chmp-list-questions-be-addressed-applicantsmarketing-authorisation-holders_en.pdf"},
    {"id":"11627","name":"CHMP summary of positive opinion for Ryzodeg","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2012-10-19T14:30:00Z","reference_number":"EMA/CHMP/582765/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ryzodeg_en.pdf"},
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    {"id":"11631","name":"Presentation - Use of single arm cohorts/trials to demonstrate clinical benefit for breakthrough therapies and results (Eric H. Rubin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T02:00:00Z","last_updated_date":"2016-08-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-single-arm-cohortstrials-demonstrate-clinical-benefit-breakthrough-therapies-and-results-eric-h-rubin_en.pdf"},
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    {"id":"11634","name":"Presentation - Real World Evidence (RWE) – what have we learned recently at EMA? - EMA's PCWP and HCPWP joint meeting (Kieran Breen, Jamie Wilkinson, Courtney Coleman, Isabel Proano, Sofia Marcha, Birgit Bauer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-real-world-evidence-rwe-what-have-we-learned-recently-ema-emas-pcwp-and-hcpwp-joint-meeting-kieran-breen-jamie-wilkinson-courtney-coleman-isabel-proano-sofia-marcha-birgit-bauer_en.pdf"},
    {"id":"11637","name":"EU/3/16/1645: Public summary of opinion on orphan designation: Cannabidiol for the prevention of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/252372/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161645-public-summary-opinion-orphan-designation-cannabidiol-prevention-graft-versus-host-disease_en.pdf"},
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    {"id":"11642","name":"Ecomectin 18.7mg/g Oral Paste for Horses - Article 33 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-02-21T00:59:00Z","last_updated_date":"2008-02-21T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ecomectin-187mgg-oral-paste-horses-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"11647","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/CHMP/82703/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-1"},
    {"id":"11648","name":"Questions and answers on Article 13 referral procedures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-07-06T18:00:00Z","last_updated_date":"2016-07-06T18:00:00Z","reference_number":"EMA/265223/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-article-13-referral-procedures_en.pdf"},
    {"id":"11649","name":"Superseded list of references supporting the assessment report on: Equiseti herba Equisetum arvense L., herba (horsetail)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2016-03-17T01:09:21Z","reference_number":"EMEA/HMPC/394897/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-equiseti-herba-equisetum-arvense-l-herba-horsetail_en.pdf"},
    {"id":"11650","name":"Zerit R-79 PI highlighted","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-02-18T14:06:21Z","last_updated_date":"2011-02-18T14:06:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/zerit-r-79-pi-highlighted_en.pdf"},
    {"id":"11652","name":"COMP meeting report on the review of applications for orphan designation: July 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-07-19T12:20:00Z","last_updated_date":"2013-07-19T12:20:00Z","reference_number":"EMA/COMP/378822/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-july-2013_en.pdf"},
    {"id":"11653","name":"Presentation - Agenda item 2: Ginas meeting highlights","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-10-29T01:00:00Z","last_updated_date":"2015-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-item-2-ginas-meeting-highlights_en.pdf"},
    {"id":"11654","name":"Irinotecan (except for liposomal formulations): List of nationally authorised medicinal products - PSUSA/00001783/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-06T13:10:00Z","last_updated_date":"2018-03-06T13:39:16Z","reference_number":"EMA/141276/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/irinotecan-except-liposomal-formulations-list-nationally-authorised-medicinal-products-psusa00001783201705_en.pdf"},
    {"id":"11657","name":"Commercial confidential information - Principles to be considered","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/commercial-confidential-information-principles-be-considered_en.pdf"},
    {"id":"11659","name":"Agenda - Ninth industry stakeholder platform on the operation of EU pharmacovigilance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-09-20T17:52:00Z","last_updated_date":"2016-09-20T17:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ninth-industry-stakeholder-platform-operation-eu-pharmacovigilance_en.pdf"},
    {"id":"11660","name":"Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/41643/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/dienogestethinylestradiol-can-be-used-acne-after-certain-other-treatments-have-failed_en.pdf"},
    {"id":"11661","name":"Agenda - EMEA-EFPIA Info day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-emea-efpia-info-day_en.pdf"},
    {"id":"11664","name":"EU/3/15/1602: Public summary of opinion on orphan designation: Live attenuated Listeria monocytogenes transfected with plasmids encoding the HPV-16E7 protein fused to a truncated fragment of the Lm protein listeriolysin ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T01:00:00Z","reference_number":"EMA/COMP/861603/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151602-public-summary-opinion-orphan-designation-live-attenuated-listeria-monocytogenes-transfected-plasmids-encoding-hpv-16e7-protein-fused-truncated-fragment-lm-protein-listeriolysin_en.pdf"},
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    {"id":"11677","name":"Draft list of references supporting the assessment of Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"EMA/434955/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-curcuma-longa-l-c-domestica-valeton-rhizome-revision-1_en.pdf"},
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    {"id":"11681","name":"Agenda - Workshop on product shortages due to manufacturing and quality problems: Developing a proactive approach to prevention","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-10-09T14:00:00Z","last_updated_date":"2013-10-10T18:00:00Z","reference_number":"EMA/INS/GMP/461767/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-product-shortages-due-manufacturing-and-quality-problems-developing-proactive-approach-prevention_en.pdf"},
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    {"id":"11684","name":"Guideline on data elements for the electronic submission of adverse reaction reports related to veterinary medicinal products authorised in the european economic area (EEA) including message and transmission specificatio...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-02-01T01:00:00Z","last_updated_date":"2016-04-14T14:30:00Z","reference_number":"EMA/CVMP/65/2003 Version 2.2.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-elements-electronic-submission-adverse-reaction-reports-related-veterinary-medicinal-products-authorised-european-economic-area-eea-including-message-and-transmission-specificatio_en.pdf"},
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    {"id":"11689","name":"Vigabatrin: List of nationally authorised medicinal products - PSUSA/00003112/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T20:00:00Z","last_updated_date":"2018-05-23T20:22:17Z","reference_number":"EMA/303471/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/vigabatrin-list-nationally-authorised-medicinal-products-psusa00003112201709_en.pdf"},
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    {"id":"11713","name":"Iclusig Article-20 procedure - Product information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-product-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/iclusig-article-20-procedure-product-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/iclusig-article-20-procedure-product-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/iclusig-article-20-procedure-product-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/iclusig-article-20-procedure-product-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/iclusig-article-20-procedure-product-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/iclusig-article-20-procedure-product-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/iclusig-article-20-procedure-product-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/iclusig-article-20-procedure-product-information_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/iclusig-article-20-procedure-product-information_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/iclusig-article-20-procedure-product-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/iclusig-article-20-procedure-product-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/iclusig-article-20-procedure-product-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/iclusig-article-20-procedure-product-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/iclusig-article-20-procedure-product-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/iclusig-article-20-procedure-product-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/iclusig-article-20-procedure-product-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/iclusig-article-20-procedure-product-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/iclusig-article-20-procedure-product-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/iclusig-article-20-procedure-product-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/iclusig-article-20-procedure-product-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/iclusig-article-20-procedure-product-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/iclusig-article-20-procedure-product-information_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/iclusig-article-20-procedure-product-information_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/iclusig-article-20-procedure-product-information_no.pdf"}},
    {"id":"11714","name":"Withdrawal letter : Docetaxel Winthrop","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T01:00:00Z","last_updated_date":"2008-11-14T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-docetaxel-winthrop_en.pdf"},
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    {"id":"11721","name":"Report on the workshop expression of strength in the name of medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-10T01:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMEA/213927/2009","document_url":"https://www.ema.europa.eu/en/documents/other/report-workshop-expression-strength-name-medicines_en.pdf"},
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    {"id":"11739","name":"EU/3/10/736: Public summary of opinion on orphan designation: Glyceryl tri-(4-phenylbutyrate) for the treatment of argininosuccinic aciduria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"EMA/COMP/123458/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310736-public-summary-opinion-orphan-designation-glyceryl-tri-4-phenylbutyrate-treatment-argininosuccinic-aciduria_en.pdf"},
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    {"id":"11742","name":"List of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (15 March 2017)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"EMA/101021/2017","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-15-march-2017_en.pdf"},
    {"id":"11743","name":"Paracetamol / tramadol: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002310/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T14:00:00Z","last_updated_date":"2016-10-17T16:59:47Z","reference_number":"EMA/319353/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-tramadol-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002310201508_en.pdf"},
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    {"id":"11752","name":"Public statement on the suspension of the marketing authorisation for Bextra (Valdecoxib) in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-10-27T02:00:00Z","last_updated_date":"2005-10-27T02:00:00Z","reference_number":"EMEA/358234/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-suspension-marketing-authorisation-bextra-valdecoxib-european-union_en.pdf"},
    {"id":"11753","name":"Nadifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -    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    {"id":"11754","name":"Presentation - The use of antibiotics in humans in the EU: assessing the community and hospital settings (Anna-Pelagia Magiorakos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-antibiotics-humans-eu-assessing-community-and-hospital-settings-anna-pelagia-magiorakos_en.pdf"},
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    {"id":"11759","name":"Presentation - EMA Veterinary Portfolio Reviews “Horizon scanning” (Fia Westerholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T02:00:00Z","last_updated_date":"2017-03-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-veterinary-portfolio-reviews-horizon-scanning-fia-westerholm_en.pdf"},
    {"id":"11761","name":"Codeine Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-05-18T02:00:00Z","last_updated_date":"2015-05-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-iv_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-annex-iv_bg.pdf-0","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-annex-iv_es.pdf-0","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-annex-iv_cs.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-annex-iv_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-annex-iv_de.pdf-0","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-annex-iv_et.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-annex-iv_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-annex-iv_fr.pdf-0","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-annex-iv_hr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-annex-iv_it.pdf-0","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-annex-iv_lv.pdf-0","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-annex-iv_lt.pdf-0","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-annex-iv_hu.pdf-0","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-annex-iv_mt.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-annex-iv_nl.pdf-0","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-annex-iv_pl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-annex-iv_pt.pdf-0","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-annex-iv_ro.pdf-0","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-annex-iv_sk.pdf-0","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-annex-iv_sl.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-annex-iv_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-annex-iv_sv.pdf-0"}},
    {"id":"11763","name":"EU/3/10/726: Public summary of opinion on orphan designation: Taliglucerase alfa for the treatment of Gaucher disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMA/COMP/38662/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310726-public-summary-opinion-orphan-designation-taliglucerase-alfa-treatment-gaucher-disease_en.pdf"},
    {"id":"11764","name":"EU/3/06/402: Public summary of positive opinion for orphan designation of opebacan for the treatment of meningococcal disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/427851/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306402-public-summary-positive-opinion-orphan-designation-opebacan-treatment-meningococcal-disease_en.pdf"},
    {"id":"11765","name":"Presentation - European Medicines Agency (EMA) - Substance, product, organisation and referential data (SPOR) impact on veterinary stakeholders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-27T01:00:00Z","last_updated_date":"2018-02-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-ema-substance-product-organisation-and-referential-data-spor-impact-veterinary-stakeholders_en.pdf"},
    {"id":"11766","name":"Presentation - Clinical trials designs in neuromyelitis optica and spectrum disorders: Endpoints industry (Ayesh Perera)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-designs-neuromyelitis-optica-and-spectrum-disorders-endpoints-industry-ayesh-perera_en.pdf"},
    {"id":"11767","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-08-17T17:10:00Z","last_updated_date":"2016-08-17T17:10:00Z","reference_number":"EMA/499630/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-july-2016_en.pdf"},
    {"id":"11769","name":"Public Statement on Capsicum / capsaicin containing herbal medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-23T01:00:00Z","last_updated_date":"2005-11-23T01:00:00Z","reference_number":"EMEA/HMPC/138379/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-capsicum-capsaicin-containing-herbal-medicinal-products_en.pdf"},
    {"id":"11770","name":"Deoxycholic acid : List of nationally authorised medicinal products - PSUSA/00010525/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-05T16:16:00Z","last_updated_date":"2017-12-05T16:19:19Z","reference_number":"EMA/753957/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/deoxycholic-acid-list-nationally-authorised-medicinal-products-psusa00010525201704_en.pdf"},
    {"id":"11774","name":"Nimesulide - Article 31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-04-19T02:00:00Z","last_updated_date":"2012-04-19T02:00:00Z","reference_number":"EMA/73856/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/nimesulide-article-31-referral-assessment-report_en.pdf"},
    {"id":"11776","name":"Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-02-01T01:00:00Z","last_updated_date":"2007-02-01T01:00:00Z","reference_number":"EMEA/CVMP/EWP/117899/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-efficacy-and-target-animal-safety-data-requirements-veterinary-medicinal-products-intended-minor-uses-or-minor-species_en.pdf"},
    {"id":"11778","name":"Sandimmun Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T17:00:00Z","last_updated_date":"2013-12-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sandimmun-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sandimmun-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sandimmun-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sandimmun-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sandimmun-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sandimmun-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sandimmun-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sandimmun-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sandimmun-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sandimmun-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sandimmun-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sandimmun-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sandimmun-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sandimmun-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sandimmun-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sandimmun-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sandimmun-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sandimmun-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sandimmun-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sandimmun-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sandimmun-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sandimmun-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sandimmun-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"11780","name":"Qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for positron-emission-tomography amyloid imaging (positive / negative) as a biomarker for enrichment, for use in regulatory clinical trials in...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-04-04T17:00:00Z","last_updated_date":"2012-04-04T17:00:00Z","reference_number":"EMA/CHMP/SAWP/892998/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-alzheimers-disease-novel-methodologies-biomarkers-positron-emission-tomography-amyloid-imaging-positive-negative-biomarker-enrichment-use-regulatory-clinical-trials_en.pdf"},
    {"id":"11784","name":"CHMP post-authorisation summary of positive opinion for Irbesartan Zentiva","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/CHMP/388301/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-irbesartan-zentiva_en.pdf"},
    {"id":"11785","name":"Background review for the excipient boric acid: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report","type":"report","status":"Draft","consultation_date":"","first_published_date":"2015-08-04T02:00:00Z","last_updated_date":"2015-08-04T02:00:00Z","reference_number":"EMA/CHMP/765436/2012","document_url":"https://www.ema.europa.eu/en/documents/report/background-review-excipient-boric-acid-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-draft-report_en.pdf"},
    {"id":"11786","name":"Guide on the interpretation of spontaneous case reports of suspected adverse reactions to medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/CHMP/PhVWP/646186/2010","document_url":"https://www.ema.europa.eu/en/documents/report/guide-interpretation-spontaneous-case-reports-suspected-adverse-reactions-medicines_en.pdf"},
    {"id":"11788","name":"European Medicines Agency adopts positive opinion for avian influenza vaccines for use in birds","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-07-21T02:00:00Z","last_updated_date":"2009-07-21T02:00:00Z","reference_number":"EMEA/281842/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-adopts-positive-opinion-avian-influenza-vaccines-use-birds_en.pdf"},
    {"id":"11789","name":"CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/503858/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-epoetin-alfa-hexal_en.pdf"},
    {"id":"11791","name":"Presentation - Evaluation, classification and weighting of medication errors from an industry perspective (Liz Swain)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evaluation-classification-and-weighting-medication-errors-industry-perspective-liz-swain_en.pdf"},
    {"id":"11792","name":"CHMP summary of opinion for Kovaltry","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/CHMP/774664/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-kovaltry_en.pdf"},
    {"id":"11793","name":"Recognition criteria for self assessment - Enpr-EMA: Belgian Pediatric Drug Network - BPDN","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-01-07T00:31:00Z","last_updated_date":"2010-01-07T00:31:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-belgian-pediatric-drug-network-bpdn_en.pdf"},
    {"id":"11794","name":"Guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-01-24T01:00:00Z","last_updated_date":"2008-01-24T01:00:00Z","reference_number":"EMEA/CHMP/SWP/169215/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-need-non-clinical-testing-juvenile-animals-pharmaceuticals-paediatric-indications_en.pdf"},
    {"id":"11795","name":"Presentation - Veterinarians experiences: Cattle (I.Lorenz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinarians-experiences-cattle-ilorenz_en.pdf"},
    {"id":"11796","name":"Bromocriptine Article-31 referral - Restrictions in use of bromocriptine for stopping breast milk production","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"EMA/698187/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bromocriptine-article-31-referral-restrictions-use-bromocriptine-stopping-breast-milk-production_sv.pdf"}},
    {"id":"11797","name":"Monthly report - Pharmacovigilance Working Party (PhVWP) December 2011 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-01-10T13:00:00Z","last_updated_date":"2012-04-03T16:00:00Z","reference_number":"EMA/CHMP/PhVWP/973945/2011","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-december-2011-plenary-meeting_en.pdf"},
    {"id":"11798","name":"Request for confirmation of the applicability of the Agency's decision on class waivers","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-03-12T01:00:00Z","last_updated_date":"2019-03-20T09:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-confirmation-applicability-agencys-decision-class-waivers_en.docx"},
    {"id":"11800","name":"EU/3/08/537: Public summary of positive opinion for orphan designation of autologous urothelial and smooth muscle cells for the treatment of spina bifida","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMEA/COMP/49041/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308537-public-summary-positive-opinion-orphan-designation-autologous-urothelial-and-smooth-muscle-cells-treatment-spina-bifida_en.pdf"},
    {"id":"11801","name":"Strontium [89sr] chloride: List of nationally authorised medicinal products - PSUSA/00002795/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T11:10:00Z","last_updated_date":"2018-01-18T11:10:00Z","reference_number":"EMA/35112/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/strontium-89sr-chloride-list-nationally-authorised-medicinal-products-psusa00002795201705_en.pdf"},
    {"id":"11803","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 12-14 June 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T18:15:00Z","last_updated_date":"2012-06-15T18:15:00Z","reference_number":"EMA/CVMP/358270/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-june-2012_en.pdf"},
    {"id":"11809","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 30-31 March 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-04T02:00:00Z","last_updated_date":"2011-05-04T02:00:00Z","reference_number":"EMA/HMPC/288516/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-30-31-march-2011_en.pdf"},
    {"id":"11811","name":"EMA to review Inductos","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T14:00:01Z","last_updated_date":"2015-07-24T14:00:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-review-inductos_en.pdf"},
    {"id":"11812","name":"Standard operating procedure for review and approval of VICH guidelines by CVMP and its working parties","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2009-08-24T02:00:00Z","last_updated_date":"2015-09-02T16:50:00Z","reference_number":"SOP/V/4047","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-review-and-approval-vich-guidelines-cvmp-and-its-working-parties_en.pdf"},
    {"id":"11814","name":"Agenda and registration form - Joint Drug Information Association/European Medicines Agency information day on post-authorisation studies (PAS)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-04-08T02:00:00Z","last_updated_date":"2015-06-02T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-joint-drug-information-associationeuropean-medicines-agency-information-day-post-authorisation-studies-pas_en.pdf"},
    {"id":"11815","name":"Calcitonin: Product information as approved by the CHMP on 19 July 2012, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T17:00:00Z","last_updated_date":"2012-07-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/calcitonin-product-information-approved-chmp-19-july-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"11816","name":"Pathogen-specific database: Glanders and Melioidosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-glanders-and-melioidosis_en.pdf"},
    {"id":"11817","name":"Agenda - Workshop on regulatory and scientific issues related to the Investigation of medicinal products intended for neonatal use - Neonates Workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-08-31T02:09:21Z","last_updated_date":"2006-08-31T02:09:21Z","reference_number":"EMEA/359419/2006","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-regulatory-and-scientific-issues-related-investigation-medicinal-products-intended-neonatal-use-neonates-workshop_en.pdf"},
    {"id":"11818","name":"CHMP post-authorisation summary of positive opinion for Zontivity (II/0005)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2017-09-20T02:00:00Z","reference_number":"EMA/CHMP/420912/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zontivity-ii0005_en.pdf"},
    {"id":"11820","name":"Initial notices for parallel distribution – April 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-05-19T17:00:00Z","last_updated_date":"2014-05-19T17:00:00Z","reference_number":"EMA/270666/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-april-2014_en.pdf"},
    {"id":"11821","name":"Agenda - CAT scientific workshop: Reducing the number of laboratory animals used in tissue-engineering research","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-11-12T18:15:00Z","last_updated_date":"2012-11-12T18:15:00Z","reference_number":"EMA/CAT/653272/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-scientific-workshop-reducing-number-laboratory-animals-used-tissue-engineering-research_en.pdf"},
    {"id":"11823","name":"Presentation - Single arm trials in the context (era) of platforms (R. Kaplan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T02:00:00Z","last_updated_date":"2016-08-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-single-arm-trials-context-era-platforms-r-kaplan_en.pdf"},
    {"id":"11824","name":"Meeting highlights from the Paediatric Committee 9 - 11 April 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-04-15T02:00:00Z","last_updated_date":"2008-04-15T02:00:00Z","reference_number":"EMEA/PDCO/190452/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-9-11-april-2008_en.pdf"},
    {"id":"11826","name":"Withdrawal assessment report for Omontys","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-09-10T02:00:00Z","last_updated_date":"2013-09-10T02:00:00Z","reference_number":"EMA/419554/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-omontys_en.pdf"},
    {"id":"11829","name":"EU/3/07/510: Public summary of positive opinion for orphan designation of artesunate for the treatment of malaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"EMEA/COMP/486932/2007 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307510-public-summary-positive-opinion-orphan-designation-artesunate-treatment-malaria_en.pdf"},
    {"id":"11832","name":"Canazole - Article 29 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-09T01:00:00Z","last_updated_date":"2012-02-09T01:00:00Z","reference_number":"EMEA/H/A-29/1286","document_url":"https://www.ema.europa.eu/en/documents/referral/canazole-article-29-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/canazole-article-29-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/canazole-article-29-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/canazole-article-29-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/canazole-article-29-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/canazole-article-29-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/canazole-article-29-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/canazole-article-29-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/canazole-article-29-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/canazole-article-29-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/canazole-article-29-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/canazole-article-29-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/canazole-article-29-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/canazole-article-29-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/canazole-article-29-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/canazole-article-29-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/canazole-article-29-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/canazole-article-29-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/canazole-article-29-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/canazole-article-29-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/canazole-article-29-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/canazole-article-29-referral-annex-i_sv.pdf"}},
    {"id":"11834","name":"Work programme for the European Agency for the Evaluation of Medicinal Products 2000-2001","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2001-02-16T00:09:21Z","last_updated_date":"2001-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2000-2001_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2000-2001_es.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2000-2001_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2000-2001_fr.pdf"}},
    {"id":"11836","name":"Adaptive pathways: key learnings and next steps","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-08-03T14:00:00Z","last_updated_date":"2016-08-03T14:00:00Z","reference_number":"EMA/484516/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/adaptive-pathways-key-learnings-and-next-steps_en.pdf"},
    {"id":"11840","name":"Withdrawal assessment report for Cerepro","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-04-14T02:00:00Z","last_updated_date":"2009-04-14T02:00:00Z","reference_number":"EMEA/203243/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-cerepro_en.pdf"},
    {"id":"11841","name":"Guideline on virus safety evaluation of biotechnological investigational medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/BWP/398498/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-virus-safety-evaluation-biotechnological-investigational-medicinal-products_en.pdf"},
    {"id":"11842","name":"CHMP post-authorisation summary of positive opinion for Opdivo (II/0002)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/CHMP/148121/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo-ii0002_en.pdf"},
    {"id":"11844","name":"Questions and Answers relating to Tender EMEA 2008 71 PM IT.","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"EMEA 2008 71 PM IT","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-tender-emea-2008-71-pm-it_en.pdf"},
    {"id":"11845","name":"Questions and answers on drug interactions between Victrelis (boceprevir) and ritonavir-boosted HIV protease inhibitors","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T17:07:13Z","last_updated_date":"2012-02-16T17:07:13Z","reference_number":"EMA/CHMP/117973/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-drug-interactions-between-victrelis-boceprevir-and-ritonavir-boosted-hiv-protease-inhibitors_en.pdf"},
    {"id":"11846","name":"Public summary of the evaluation of a proposed product-specific\n\nwaiver: Amlodipine / ramipril for treatment of hypertension","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T12:30:00Z","last_updated_date":"2015-02-23T12:30:00Z","reference_number":"EMA/50883/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-amlodipine-ramipril-treatment-hypertension_en.pdf"},
    {"id":"11847","name":"Agenda - Twelfth joint EMA/EUnetHTA dialogue meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T13:00:00Z","last_updated_date":"2016-12-05T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-twelfth-joint-emaeunethta-dialogue-meeting_en.pdf"},
    {"id":"11848","name":"Committee for Proprietary Medicinal Products (CPMP) 27th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-05-16T02:00:00Z","last_updated_date":"1997-05-16T02:00:00Z","reference_number":"CPMP/389/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-27th-plenary-meeting_en.pdf"},
    {"id":"11849","name":"Presentation - Joint industry presentation - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T02:00:00Z","last_updated_date":"2018-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-industry-presentation-industry-stakeholder-meeting-brexit-and-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"11850","name":"Presentation - European Commission (Flora Giorgio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T01:00:00Z","last_updated_date":"2013-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-commission-flora-giorgio_en.pdf"},
    {"id":"11852","name":"Zinnat - Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T01:00:00Z","last_updated_date":"2013-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinnat-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinnat-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinnat-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinnat-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinnat-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinnat-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinnat-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinnat-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinnat-article-30-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinnat-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinnat-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinnat-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinnat-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinnat-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinnat-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinnat-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinnat-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinnat-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinnat-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinnat-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinnat-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinnat-article-30-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/zinnat-article-30-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/zinnat-article-30-referral-annex-i_no.pdf"}},
    {"id":"11854","name":"Bupropion: List of nationally authorised medicinal products - PSUSA/00000461/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-18T17:02:00Z","last_updated_date":"2016-11-18T17:07:54Z","reference_number":"EMA/755927/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/bupropion-list-nationally-authorised-medicinal-products-psusa00000461201512_en.pdf"},
    {"id":"11855","name":"Annex to the request for a joint ECDC, EFSA and EMA scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food-producing animal...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-01-05T01:00:00Z","last_updated_date":"2017-01-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-request-joint-ecdc-efsa-and-ema-scientific-opinion-list-outcome-indicators-regards-surveillance-antimicrobial-resistance-and-antimicrobial-consumption-humans-and-food-producing-animal_en.pdf"},
    {"id":"11857","name":"fYRoM - Ministry of Health, M Hadzihamza","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/fyrom-ministry-health-m-hadzihamza_en.pdf"},
    {"id":"11859","name":"Presentation - Agenda item 5: ISO IDMP actions log","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-10-29T01:00:00Z","last_updated_date":"2015-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-item-5-iso-idmp-actions-log_en.pdf"},
    {"id":"11862","name":"Presentation - Keynote lecture - Key ongoing applications in nanosciences and how they apply to pharmaceuticals, Rutledge Ellis-Behnke, MIT","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-keynote-lecture-key-ongoing-applications-nanosciences-and-how-they-apply-pharmaceuticals-rutledge-ellis-behnke-mit_en.pdf"},
    {"id":"11863","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 9-11 December 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/CVMP/731849/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-december-2014_en.pdf"},
    {"id":"11864","name":"European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-01T17:07:22Z","last_updated_date":"2011-06-01T17:07:22Z","reference_number":"EMA/435707/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-heads-medicines-agencies-propose-measures-make-information-application-dossiers-more-transparent_en.pdf"},
    {"id":"11866","name":"EU/3/08/604: Public summary of positive opinion for orphan designation of recombinant human minibody against complement component C5 fused with RGD-motif for prevention of the ischaemia/reperfusion injury associated with...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2014-01-22T01:00:00Z","reference_number":"EMA/COMP/609861/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308604-public-summary-positive-opinion-orphan-designation-recombinant-human-minibody-against-complement-component-c5-fused-rgd-motif-prevention-ischaemiareperfusion-injury-associated_en.pdf"},
    {"id":"11869","name":"Agenda - PRAC draft agenda of meeting 3-6 November 2014","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-11-03T17:05:00Z","last_updated_date":"2014-11-03T17:05:00Z","reference_number":"EMA/PRAC/677871/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-3-6-november-2014_en.pdf"},
    {"id":"11870","name":"Highlights of the European Medicines Agency industry platform meeting on paediatric medicines held on 11 May 2015","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-07-14T13:00:00Z","last_updated_date":"2015-07-14T13:00:00Z","reference_number":"EMA/327077/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/highlights-european-medicines-agency-industry-platform-meeting-paediatric-medicines-held-11-may-2015_en.pdf"},
    {"id":"11871","name":"Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation: June 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-06-18T19:29:43Z","last_updated_date":"2012-06-18T19:29:43Z","reference_number":"EMA/COMP/343137/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-meeting-report-review-applications-orphan-designation-june-2012_en.pdf"},
    {"id":"11872","name":"Pharmion Ltd withdraws its marketing authorisation application for\n\nOrplatna (satraplatin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-08-04T02:00:00Z","last_updated_date":"2008-08-04T02:00:00Z","reference_number":"EMEA/417535/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/pharmion-ltd-withdraws-its-marketing-authorisation-application-orplatna-satraplatin_en.pdf"},
    {"id":"11873","name":"Presentation - EMA activities in the fight against antimicrobial resistance: Human medicines aspects - Session 2 (Marco Cavaleri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-activities-fight-against-antimicrobial-resistance-human-medicines-aspects-session-2-marco-cavaleri_en.pdf"},
    {"id":"11874","name":"Pre-qualification questionnaire for a restricted tender procedure organised by the European Medicines Agency - ICT service desk EMA/2013/09/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-28T02:00:00Z","last_updated_date":"2013-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-restricted-tender-procedure-organised-european-medicines-agency-ict-service-desk-ema201309ict_en.doc"},
    {"id":"11875","name":"Work programme for the European Medicines Agency 2005","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2005-02-16T00:09:21Z","last_updated_date":"2005-02-16T00:09:21Z","reference_number":"EMEA/MB/138351/2004/en/Final","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-medicines-agency-2005_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-medicines-agency-2005_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/work-programme/work-programme-european-medicines-agency-2005_cs.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/work-programme-european-medicines-agency-2005_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-medicines-agency-2005_de.pdf","et":"https://www.ema.europa.eu/et/documents/work-programme/work-programme-european-medicines-agency-2005_et.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/work-programme-european-medicines-agency-2005_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-medicines-agency-2005_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/work-programme-european-medicines-agency-2005_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/work-programme/work-programme-european-medicines-agency-2005_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/work-programme/work-programme-european-medicines-agency-2005_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/work-programme/work-programme-european-medicines-agency-2005_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/work-programme/work-programme-european-medicines-agency-2005_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/work-programme-european-medicines-agency-2005_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/work-programme/work-programme-european-medicines-agency-2005_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/work-programme/work-programme-european-medicines-agency-2005_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/work-programme/work-programme-european-medicines-agency-2005_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/work-programme/work-programme-european-medicines-agency-2005_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/work-programme-european-medicines-agency-2005_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/work-programme-european-medicines-agency-2005_sv.pdf"}},
    {"id":"11876","name":"EU/3/13/1100: Public summary of positive opinion of humanised IgG1 kappa antibody against serum amyloid A and AL amyloid for the treatment of amyloid light-chain amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T11:00:00Z","last_updated_date":"2015-05-13T12:00:00Z","reference_number":"EMA/COMP/29473/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131100-public-summary-positive-opinion-humanised-igg1-kappa-antibody-against-serum-amyloid-and-al-amyloid-treatment-amyloid-light-chain-amyloidosis_en.pdf"},
    {"id":"11878","name":"Note for guidance on clinical investigation of medicinal products in the treatment of hypertension","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-23T02:00:00Z","last_updated_date":"2004-06-23T02:00:00Z","reference_number":"CPMP/EWP/238/95 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-hypertension_en.pdf"},
    {"id":"11880","name":"Updated application software - Determination of withdrawal periods for milk","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/updated-application-software-determination-withdrawal-periods-milk_en.zip"},
    {"id":"11882","name":"Presentation - Identification and traceability of biological products: European Generic Medicines Association views","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-identification-and-traceability-biological-products-european-generic-medicines-association-views_en.pdf"},
    {"id":"11884","name":"Opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 120mg and Annexes A and B","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-01-22T00:08:21Z","last_updated_date":"1998-01-22T00:08:21Z","reference_number":"CPMP/1000/97-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-120mg-and-annexes-and-b_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-120mg-and-annexes-and-b_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-120mg-and-annexes-and-b_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-120mg-and-annexes-and-b_fr.pdf"}},
    {"id":"11885","name":"Superseded community herbal monograph on Orthosiphon stamineus Benth., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/281496/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-orthosiphon-stamineus-benth-folium_en.pdf"},
    {"id":"11886","name":"Final assessment report on Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad) and V. phlomoides L., flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T02:00:00Z","last_updated_date":"2018-06-22T02:00:00Z","reference_number":"EMA/HMPC/611531/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-verbascum-thapsus-l-v-densiflorum-bertol-v-thapsiforme-schrad-and-v-phlomoides-l-flos_en.pdf"},
    {"id":"11890","name":"PDCO meeting highlights 7-9 January 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-01-16T00:00:00Z","last_updated_date":"2009-01-16T00:00:00Z","reference_number":"EMEA/20576/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-7-9-january-2009_en.pdf"},
    {"id":"11891","name":"Questions and answers on refusal of the marketing authorisation for Delamanid","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/446276/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-delamanid_en.pdf"},
    {"id":"11893","name":"Presentation - European child and  adolescent psychopharmacology network (ECAPN) (A. Zuddas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-child-and-adolescent-psychopharmacology-network-ecapn-zuddas_en.pdf"},
    {"id":"11895","name":"Implanon - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-02-27T00:08:21Z","last_updated_date":"2008-02-27T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/implanon-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/implanon-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/implanon-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/implanon-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/implanon-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/implanon-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/implanon-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/implanon-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/implanon-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/implanon-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/implanon-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/implanon-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/implanon-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/implanon-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/implanon-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/implanon-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/implanon-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/implanon-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/implanon-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/implanon-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/implanon-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/implanon-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"11898","name":"Technical specifications - Letter of invitation to tender: Procurement procedure EMA/2014/48/PH","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2014-11-04T10:00:00Z","last_updated_date":"2014-11-04T10:00:00Z","reference_number":"EMA/473914/2014","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-letter-invitation-tender-procurement-procedure-ema201448ph_en.pdf"},
    {"id":"11899","name":"EMA reviewing safety of Uptravi for pulmonary arterial hypertension","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-14T01:00:00Z","reference_number":"EMA/83636/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-reviewing-safety-uptravi-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"11900","name":"Draft concept paper on the revision of the guidance on fixed combination medicinal products in the treatment of hypertension","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-10-18T02:00:00Z","last_updated_date":"2006-10-18T02:00:00Z","reference_number":"CHMP/EWP/426093/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-guidance-fixed-combination-medicinal-products-treatment-hypertension_en.pdf"},
    {"id":"11902","name":"CHMP summary of positive opinion for Zykadia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/140022/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zykadia_en.pdf"},
    {"id":"11903","name":"Meeting report - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on improved potency assays for inactivated influenza vaccines held on 12 December 2011","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-07-17T02:00:00Z","last_updated_date":"2012-07-17T02:00:00Z","reference_number":"EMA/142333/2012","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-joint-european-medicines-agency-european-directorate-quality-medicines-and-healthcare-workshop-improved-potency-assays-inactivated-influenza-vaccines-held-12-december-2011_en.pdf"},
    {"id":"11904","name":"Presentation - Session 5: Histology independent indications - the HTA view (Anja Schiel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-histology-independent-indications-hta-view-anja-schiel_en.pdf"},
    {"id":"11906","name":"Fusafungine Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-09-11T02:00:00Z","last_updated_date":"2015-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-review-started_en.pdf"},
    {"id":"11909","name":"Draft list of references supporting the assessment of Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-08-19T02:00:00Z","last_updated_date":"2011-08-19T02:00:00Z","reference_number":"EMA/HMPC/571121/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-glycyrrhiza-glabra-l-andor-glycyrrhiza-inflata-bat-andor-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"11911","name":"Presentation - EMA workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease (Elmer Schabel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-workshop-development-new-medicinal-products-treatment-ulcerative-colitis-and-crohns-disease-elmer-schabel_en.pdf"},
    {"id":"11912","name":"Note for guidance on repeated dose toxicity","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-07-27T02:00:00Z","last_updated_date":"2000-07-27T02:00:00Z","reference_number":"CPMP/SWP/1042/99 corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-repeated-dose-toxicity_en.pdf"},
    {"id":"11914","name":"General conditions for permanent call for expression of interest for Contract Agents for temporary assignments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-12T02:00:00Z","last_updated_date":"2010-04-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/general-conditions-permanent-call-expression-interest-contract-agents-temporary-assignments_sv.pdf"}},
    {"id":"11915","name":"EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"EMA/188204/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-suspension-medicines-due-unreliable-studies-micro-therapeutic-research-labs_en.pdf"},
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    {"id":"11923","name":"Draft revised guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-06-23T02:00:00Z","last_updated_date":"2008-06-23T02:00:00Z","reference_number":"EMEA/CVMP/ERA/418282/2005-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-revised-guideline-environmental-impact-assessment-veterinary-medicinal-products-support-vich-guidelines-gl6-and-gl-38_en.pdf"},
    {"id":"11924","name":"Fusafungine Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-09-11T02:00:00Z","last_updated_date":"2015-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-notification_en.pdf"},
    {"id":"11925","name":"Presentation - The policy context of the request for advice on the impact on public and animal health of the use of antibiotics in animals (Mario Nagtzaam)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-policy-context-request-advice-impact-public-and-animal-health-use-antibiotics-animals-mario-nagtzaam_en.pdf"},
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    {"id":"11928","name":"EU/3/12/1009: Public summary of opinion on orphan designation: Givinostat for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2012-07-24T16:00:00Z","reference_number":"EMA/350443/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121009-public-summary-opinion-orphan-designation-givinostat-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"11929","name":"Draft overview of comments received on European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus (EMA/HMPC/229413/2016)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-11-07T17:07:00Z","last_updated_date":"2016-11-07T17:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/draft-overview-comments-received-european-union-herbal-monograph-silybum-marianum-l-gaertn-fructus-emahmpc2294132016_en.pdf"},
    {"id":"11930","name":"EU/3/08/603: Public summary of positive opinion for orphan designation of pralatrexate for the treatment of non-papillary transitional cell carcinoma of the urinary bladder","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2011-04-06T02:00:00Z","reference_number":"EMEA/COMP/667375/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308603-public-summary-positive-opinion-orphan-designation-pralatrexate-treatment-non-papillary-transitional-cell-carcinoma-urinary-bladder_en.pdf"},
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    {"id":"11937","name":"Pre-accession product information linguistic review process (PALC III)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-08-16T02:00:00Z","reference_number":"EMA/48630/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/pre-accession-product-information-linguistic-review-process-palc-iii_en.pdf"},
    {"id":"11939","name":"Presentation - Pharmacovigilance Risk Assessment Committee - Five years of operation (J. Raine, PRAC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-risk-assessment-committee-five-years-operation-j-raine-prac_en.pdf"},
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    {"id":"11986","name":"Presentation - Outcomes of the annual Enpr-EMA workshop (Mark Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outcomes-annual-enpr-ema-workshop-mark-turner_en.pdf"},
    {"id":"11991","name":"Overview of comments received on 'Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-30T14:15:00Z","last_updated_date":"2013-05-30T14:15:00Z","reference_number":"EMA/CHMP/47495/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-prophylaxis-high-intra-and-post-operative-venous-thromboembolic-risk_en.pdf"},
    {"id":"11992","name":"Presentation - Statistical considerations in setting acceptance criteria, Kay-Martin Hanschmann, Paul Ehrlich Institut","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T02:00:00Z","last_updated_date":"2011-10-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-statistical-considerations-setting-acceptance-criteria-kay-martin-hanschmann-paul-ehrlich-institut_en.pdf"},
    {"id":"11993","name":"Symbioflor 2 Article-31 referral - CHMP assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-09-07T02:00:00Z","last_updated_date":"2017-09-07T02:00:00Z","reference_number":"EMA/530965/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/symbioflor-2-article-31-referral-chmp-assessment-report_en.pdf"},
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    {"id":"12047","name":"CVMP post-authorisation summary of negative opinion for Respiporc FLUpan H1N1","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2016-12-09T17:00:00Z","last_updated_date":"2016-12-09T17:00:00Z","reference_number":"EMA/CVMP/748641/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-post-authorisation-summary-negative-opinion-respiporc-flupan-h1n1_en.pdf"},
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    {"id":"12050","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 21 – 24 October 2013","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2013-10-25T15:00:00Z","last_updated_date":"2013-10-25T15:00:00Z","reference_number":"EMA/CHMP/SAWP/657916/2013","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-21-24-october-2013_en.pdf"},
    {"id":"12051","name":"Update report on the Agency’s European Union Telematics: Operations report","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-14T16:30:00Z","last_updated_date":"2012-06-14T16:30:00Z","reference_number":"EMA/310155/2012","document_url":"https://www.ema.europa.eu/en/documents/report/update-report-agencys-european-union-telematics-operations-report_en.pdf"},
    {"id":"12053","name":"Withdrawal letter: Efgratin","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-efgratin_en.pdf"},
    {"id":"12056","name":"Work plan for Good Clinical Practice Inspectors Working Group 2015","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T15:40:00Z","last_updated_date":"2015-03-06T15:40:00Z","reference_number":"EMA/INS/GCP/434364/2014","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-good-clinical-practice-inspectors-working-group-2015_en.pdf"},
    {"id":"12058","name":"CPAR - updated document February","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-15T10:57:00Z","last_updated_date":"2017-02-16T10:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cpar-updated-document-february_en.pdf"},
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    {"id":"12062","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (Cx601) for treatment of anal fistulas","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-25T12:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/674179/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-expanded-human-allogeneic-mesenchymal-adult-stem-cells-extracted-adipose-tissue-cx601-treatment-anal-fistulas_en.pdf"},
    {"id":"12063","name":"Presentation - Confirmatory subgroup analyses: Case studies (Bretz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T15:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-confirmatory-subgroup-analyses-case-studies-bretz_en.pdf"},
    {"id":"12065","name":"Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord  seeded on acellular amniotic matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T17:00:00Z","last_updated_date":"2016-04-12T17:00:00Z","reference_number":"EMA/241002/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-co-culture-keratinocytes-and-mesenchymal-stem-cells-isolated-umbilical-cord-seeded-acellular-amniotic-matrix_en.pdf"},
    {"id":"12067","name":"Calendar of 2009 dates for the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/386297/2008","document_url":"https://www.ema.europa.eu/en/documents/other/calendar-2009-dates-european-medicines-agency_en.pdf"},
    {"id":"12070","name":"Agenda - 2017 annual workshop of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-02-09T15:00:00Z","last_updated_date":"2017-05-22T16:00:00Z","reference_number":"EMA/452047/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2017-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"12071","name":"Opinion of the CVMP on the establishment of maximum residue limits: Clodronic acid","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-09-09T18:15:00Z","last_updated_date":"2015-09-09T18:15:00Z","reference_number":"EMA/CVMP/239251/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-clodronic-acid_en.pdf"},
    {"id":"12073","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency:  Newcastle Children's Cancer and Leukaemia Group Pharmacology Studies Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-newcastle-childrens-cancer-and-leukaemia-group-pharmacology-studies-group_en.pdf"},
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    {"id":"12078","name":"Iloprost (iv solution): List of nationally authorised medicinal products - PSUSA/00009190/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-15T02:00:00Z","last_updated_date":"2016-10-17T17:46:00Z","reference_number":"EMA/681056/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/iloprost-iv-solution-list-nationally-authorised-medicinal-products-psusa00009190201501_en.pdf"},
    {"id":"12080","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-08-07T18:20:00Z","last_updated_date":"2014-08-08T11:30:00Z","reference_number":"EMA/418545/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-july-2014_en.pdf"},
    {"id":"12081","name":"Organisational matters: Committee for Medicinal Products for Human Use meeting 17-20 October 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-24T13:37:00Z","last_updated_date":"2011-10-24T13:37:00Z","reference_number":"EMA/CHMP/832562/2011","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-committee-medicinal-products-human-use-meeting-17-20-october-2011_en.pdf"},
    {"id":"12083","name":"Committee for medicinal products for veterinary use: Meeting of 15-17 April 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-04-20T02:09:21Z","last_updated_date":"2009-04-20T02:09:21Z","reference_number":"EMEA/CVMP/199749/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-15-17-april-2009_en.pdf"},
    {"id":"12084","name":"Enurace 50 - Article 33 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-16T00:59:00Z","last_updated_date":"2007-11-16T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/enurace-50-article-33-referral-annex-i-ii-iii_sv.pdf"}},
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    {"id":"12089","name":"VWP Conclusions from the Workshop on Co-administration of Vaccines\n\nheld on 31 Jan-1 Feb 2006","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-01-16T00:09:21Z","last_updated_date":"2007-01-16T00:09:21Z","reference_number":"EMEA/CHMP/VWP/14684/2007","document_url":"https://www.ema.europa.eu/en/documents/other/vwp-conclusions-workshop-co-administration-vaccines-held-31-jan-1-feb-2006_en.pdf"},
    {"id":"12095","name":"Draft list of references for assessment of: Solidaginis virgaureae herba Solidago virgaurea L. (European goldenrod)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/434192/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-solidaginis-virgaureae-herba-solidago-virgaurea-l-european-goldenrod_en.pdf"},
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    {"id":"12098","name":"CMDh endorses restricted use of bromocriptine for stopping breast milk production","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-08-21T02:00:00Z","last_updated_date":"2014-08-21T02:00:00Z","reference_number":"EMA/441377/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/cmdh-endorses-restricted-use-bromocriptine-stopping-breast-milk-production_en.pdf"},
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    {"id":"12102","name":"Withdrawal assessment report for Viagra","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-06-26T02:00:00Z","last_updated_date":"2008-06-26T02:00:00Z","reference_number":"EMEA/130321/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-viagra_en.pdf"},
    {"id":"12109","name":"Technical specifications - Annex V Tenderer information form: Procurement procedure EMA/2014/50/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2014-12-11T17:15:00Z","last_updated_date":"2015-01-08T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-v-tenderer-information-form-procurement-procedure-ema201450re_en.pdf"},
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    {"id":"12118","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 July 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-08-10T19:30:00Z","last_updated_date":"2018-08-10T19:30:00Z","reference_number":"EMA/PDCO/530202/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-24-27-july-2018_en.pdf"},
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    {"id":"12139","name":"Committee for Advanced Therapies (CAT) monthly report of application procedures, guidelines and related documents on advanced therapies: March 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-03-19T16:40:00Z","last_updated_date":"2012-03-19T16:40:00Z","reference_number":"EMA/CAT/180791/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-march-2012-meeting_en.pdf"},
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    {"id":"12152","name":"List of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting 9 March 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"EMA/855463/2015","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-9-march-2016_en.pdf"},
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    {"id":"12159","name":"Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-09-05T14:30:00Z","last_updated_date":"2018-09-05T14:30:00Z","reference_number":"EMA/CVMP/698003/2017","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-eprinomectin_en.pdf-0"},
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    {"id":"12167","name":"Annex C - Response questionnaire Curricula Vitae","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-c-response-questionnaire-curricula-vitae_en.xls"},
    {"id":"12168","name":"Overview of comments received on 'Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-05-17T02:00:00Z","last_updated_date":"2011-05-17T02:00:00Z","reference_number":"EMA/CVMP/EWP/324700/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-demonstration-target-animal-safety-and-efficacy-veterinary-medicinal-products-intended-use-farmed-finfish_en.pdf"},
    {"id":"12172","name":"European Medicines Agency budget for 2008","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-02-09T00:09:21Z","last_updated_date":"2009-02-09T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2008_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/report/european-medicines-agency-budget-2008_bg.pdf","es":"https://www.ema.europa.eu/es/documents/report/european-medicines-agency-budget-2008_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/report/european-medicines-agency-budget-2008_cs.pdf","da":"https://www.ema.europa.eu/da/documents/report/european-medicines-agency-budget-2008_da.pdf","de":"https://www.ema.europa.eu/de/documents/report/european-medicines-agency-budget-2008_de.pdf","et":"https://www.ema.europa.eu/et/documents/report/european-medicines-agency-budget-2008_et.pdf","el":"https://www.ema.europa.eu/el/documents/report/european-medicines-agency-budget-2008_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/report/european-medicines-agency-budget-2008_fr.pdf","it":"https://www.ema.europa.eu/it/documents/report/european-medicines-agency-budget-2008_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/report/european-medicines-agency-budget-2008_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/report/european-medicines-agency-budget-2008_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/report/european-medicines-agency-budget-2008_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/report/european-medicines-agency-budget-2008_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/report/european-medicines-agency-budget-2008_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/report/european-medicines-agency-budget-2008_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/report/european-medicines-agency-budget-2008_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/report/european-medicines-agency-budget-2008_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/report/european-medicines-agency-budget-2008_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/report/european-medicines-agency-budget-2008_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/report/european-medicines-agency-budget-2008_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/report/european-medicines-agency-budget-2008_sv.pdf"}},
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    {"id":"12176","name":"Public statement on Clopidogrel DURA (clopidogrel): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-07-10T02:00:00Z","last_updated_date":"2015-07-10T02:00:00Z","reference_number":"EMA/301017/2015","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-dura-clopidogrel-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"12177","name":"Presentation - Case study 2 - Oligonucleotide control strategy - Session 4 (Rachel Orr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-2-oligonucleotide-control-strategy-session-4-rachel-orr_en.pdf"},
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    {"id":"12184","name":"Concept paper on the need for the development of a paediatric addendum to the chmp note for guidance on the clinical investigation of medicinal products in the treatment of lipid disorders","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/CHMP/EWP/7895/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-development-paediatric-addendum-chmp-note-guidance-clinical-investigation-medicinal-products-treatment-lipid-disorders_en.pdf"},
    {"id":"12187","name":"Presentation - Dose response assessments: guidance, experience, expectations (Vikram Sinha)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-response-assessments-guidance-experience-expectations-vikram-sinha_en.pdf"},
    {"id":"12188","name":"Presentation - AMEG’s proposal for an early hazard characterisation to encourage the development of novel antimicrobial veterinary medicinal products - European Medicines Agency veterinary medicines innovation day (Helen...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-amegs-proposal-early-hazard-characterisation-encourage-development-novel-antimicrobial-veterinary-medicinal-products-european-medicines-agency-veterinary-medicines-innovation-day-helen_en.pdf"},
    {"id":"12189","name":"Ofloxacin (topical use): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00002204/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-10-18T12:49:42Z","reference_number":"EMA/62559/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ofloxacin-topical-use-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002204201504_en.pdf"},
    {"id":"12190","name":"EU/3/06/375: Public summary of positive opinion for orphan designation of nilotinib for the treatment of chronic myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T00:00:00Z","last_updated_date":"2020-01-20T00:00:00Z","reference_number":"EMEA/COMP/137639/2006 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306375-public-summary-positive-opinion-orphan-designation-nilotinib-treatment-chronic-myeloid-leukaemia_en.pdf"},
    {"id":"12191","name":"News bulletin for small and medium-sized enterprises - Issue 12","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-12_en.pdf"},
    {"id":"12192","name":"Overview of comments received on 'reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer) as new active substance in relation to a reference active substance which is a racem...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T15:15:00Z","last_updated_date":"2012-11-21T15:15:00Z","reference_number":"EMA/355542/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-considerations-given-designation-single-stereo-isomeric-form-enantiomer-new-active-substance-relation-reference-active-substance-which-racem_en.pdf"},
    {"id":"12194","name":"Zanil Article-35 referral - Questions and answers on Zanil and associated names, and generic products thereof","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-25T18:30:00Z","last_updated_date":"2017-10-25T18:30:00Z","reference_number":"EMA/586006/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zanil-article-35-referral-questions-and-answers-zanil-and-associated-names-and-generic-products-thereof_sv.pdf"}},
    {"id":"12195","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting on 17 September 2015","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-08-04T15:00:00Z","last_updated_date":"2015-12-11T14:00:00Z","reference_number":"EMA/347054/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-17-september-2015_en.pdf"},
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    {"id":"12197","name":"EU/3/10/807: Public summary of opinion on orphan designation methylthioninium for the treatment of frontotemporal dementia with parkinsonism-17","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2014-01-13T16:00:00Z","reference_number":"EMA/606352/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310807-public-summary-opinion-orphan-designation-methylthioninium-treatment-frontotemporal-dementia-parkinsonism-17_en.pdf"},
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    {"id":"12201","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - January 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-01-31T00:00:00Z","last_updated_date":"2009-01-31T00:00:00Z","reference_number":"EMEA/85080/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-january-2009_en.pdf"},
    {"id":"12202","name":"Anika Therapeutics S.r.l. withdraws its marketing authorisation application for Hyalograft C autograft","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-02-26T01:00:00Z","last_updated_date":"2013-02-26T01:00:00Z","reference_number":"EMA/30547/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/anika-therapeutics-srl-withdraws-its-marketing-authorisation-application-hyalograft-c-autograft_en.pdf"},
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    {"id":"12207","name":"Day 80 Assessment report - Non-clinical template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-09-01T02:09:21Z","last_updated_date":"2010-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-80-assessment-report-non-clinical-template_en.doc"},
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    {"id":"12212","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Vienna)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T12:57:00Z","last_updated_date":"2017-06-15T16:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-vienna_en.pdf"},
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    {"id":"12217","name":"Medicines for the Treatment of Pain in Children: Introduction - Daniel Brasseur","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-10-28T02:09:00Z","last_updated_date":"2004-10-28T02:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/medicines-treatment-pain-children-introduction-daniel-brasseur_en.pdf"},
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    {"id":"12221","name":"HMPC work programme for 2012-2015","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T10:45:00Z","last_updated_date":"2011-12-22T10:45:00Z","reference_number":"EMA/HMPC/501139/2011","document_url":"https://www.ema.europa.eu/en/documents/work-programme/hmpc-work-programme-2012-2015_en.pdf"},
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    {"id":"12230","name":"Concept paper on requirements for vaccines for use in birds against avian influenza virus","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-04-21T02:00:00Z","last_updated_date":"2006-04-21T02:00:00Z","reference_number":"EMEA/CVMP/86063/2006-CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-requirements-vaccines-use-birds-against-avian-influenza-virus_en.pdf"},
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    {"id":"12239","name":"EU/3/12/1050: Public summary of opinion on orphan designation: [2-Cyano-3-cyclopropyl-3-hydroxy-N-(3-methyl-4-trifluoromethylphenyl)prop-2-enamide] for the treatment of traumatic spinal-cord injury","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2012-11-16T01:00:00Z","reference_number":"EMA/COMP/629399/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121050-public-summary-opinion-orphan-designation-2-cyano-3-cyclopropyl-3-hydroxy-n-3-methyl-4-trifluoromethylphenylprop-2-enamide-treatment-traumatic-spinal-cord-injury_en.pdf"},
    {"id":"12240","name":"Revised charter of tasks and responsibilities of the Executive Director as authorising officer","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2015-03-26T14:10:00Z","last_updated_date":"2015-03-26T14:10:00Z","reference_number":"EMA/MB/56129/2015","document_url":"https://www.ema.europa.eu/en/documents/other/revised-charter-tasks-and-responsibilities-executive-director-authorising-officer_en.pdf"},
    {"id":"12241","name":"CPMP members","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-01-18T00:09:21Z","last_updated_date":"2001-01-18T00:09:21Z","reference_number":"EMEA/811/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/cpmp-members_en.pdf"},
    {"id":"12242","name":"EU/3/16/1787: Public summary of positive opinion for orphan designation of sodium benzoate for the treatment of argininosuccinic aciduria","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T16:26:00Z","last_updated_date":"2016-12-14T16:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161787-public-summary-positive-opinion-orphan-designation-sodium-benzoate-treatment-argininosuccinic-aciduria_en.pdf"},
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    {"id":"12246","name":"CHMP post-authorisation summary of positive opinion for Tyverb","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/CHMP/364588/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tyverb_en.pdf"},
    {"id":"12247","name":"Position paper on batch potency testing of immunological veterinary medicinal product","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-09-01T02:00:00Z","last_updated_date":"1998-09-01T02:00:00Z","reference_number":"CVMP/IWP/038/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-batch-potency-testing-immunological-veterinary-medicinal-product_en.pdf"},
    {"id":"12248","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 21 – 24 September 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/SAWP/635474/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-21-24-september-2015_en.pdf"},
    {"id":"12252","name":"Regulators perspective on 'Quality by Design': BWP perspective - Kowid Ho","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-09-28T02:09:21Z","last_updated_date":"2009-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/regulators-perspective-quality-design-bwp-perspective-kowid-ho_en.pdf"},
    {"id":"12253","name":"EU/3/16/1628: Public summary of opinion on orphan designation: Diaspirin cross-linked haemoglobin for the treatment of oesophageal cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2016-05-02T02:00:00Z","reference_number":"EMA/COMP/166535/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161628-public-summary-opinion-orphan-designation-diaspirin-cross-linked-haemoglobin-treatment-oesophageal-cancer_en.pdf"},
    {"id":"12254","name":"Presentation - TEDDY network (D. Bonifazi and A. Ceci)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-teddy-network-d-bonifazi-and-ceci_en.pdf"},
    {"id":"12255","name":"Proposal of minimum (EnprEMA) criteria required for recognition","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/proposal-minimum-enprema-criteria-required-recognition_en.pdf"},
    {"id":"12256","name":"European Union - Japan orphan medicines cooperation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-30T12:33:37Z","last_updated_date":"2012-07-30T12:33:37Z","reference_number":"EMA/488924/2012","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-japan-orphan-medicines-cooperation_en.pdf"},
    {"id":"12257","name":"Concept paper on the need to revise the guideline on production and\n\nQuality control of monoclonal antibodies (3AB4A, Revision December 1994)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-10-21T02:00:00Z","last_updated_date":"2004-10-21T02:00:00Z","reference_number":"CHMP/BWP/64/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-guideline-production-and-quality-control-monoclonal-antibodies-3ab4a-revision-december-1994_en.pdf"},
    {"id":"12261","name":"Presentation - Clinical Practice Consensus Guidelines International Society for Pediatric and Adolescent Diabetes","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-practice-consensus-guidelines-international-society-pediatric-and-adolescent-diabetes_en.pdf"},
    {"id":"12262","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Abilify (aripiprazole)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-01-05T01:00:00Z","last_updated_date":"2010-01-05T01:00:00Z","reference_number":"EMA/809491/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-abilify-aripiprazole_sv.pdf"}},
    {"id":"12263","name":"Public statement on Raptiva (efalizumab): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-08-03T02:00:00Z","last_updated_date":"2009-08-03T02:00:00Z","reference_number":"EMEA/487107/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-raptiva-efalizumab-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"12266","name":"Presentation - Paediatric clinical research: Commission's perspective (Florian Schmidt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-clinical-research-commissions-perspective-florian-schmidt_en.pdf"},
    {"id":"12269","name":"Committee on herbal medicinal products (HMPC): Meeting report, 31 May-1 June 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-07-15T02:00:00Z","last_updated_date":"2005-07-15T02:00:00Z","reference_number":"EMEA/HMPC/228713/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-31-may-1-june-2005_en.pdf"},
    {"id":"12271","name":"Reflection paper on physical frailty: instruments for baseline characterisation of older populations in clinical trials - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-02-22T17:30:00Z","last_updated_date":"2018-02-22T17:30:00Z","reference_number":"EMA/CHMP/778709/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-physical-frailty-instruments-baseline-characterisation-older-populations-clinical-trials-first-version_en.pdf"},
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    {"id":"12274","name":"CHMP post-authorisation summary of positive opinion for RoActemra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/288328/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-roactemra_en.pdf"},
    {"id":"12280","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 12-13 September 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-09-28T12:00:00Z","last_updated_date":"2011-09-28T12:00:00Z","reference_number":"EMA/HMPC/767990/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-12-13-september-2011_en.pdf"},
    {"id":"12281","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the December 2009 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-12-17T00:09:21Z","last_updated_date":"2009-12-17T00:09:21Z","reference_number":"EMA/COMP/718385/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-december-2009-meeting_en.pdf"},
    {"id":"12283","name":"Presentation - Update on the SPUR and PSUSA roadmap (Ana Zanoletty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-spur-and-psusa-roadmap-ana-zanoletty_en.pdf"},
    {"id":"12285","name":"Mandate, objectives and rules of procedure for the coordination group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-08-19T02:00:00Z","last_updated_date":"2010-08-19T02:00:00Z","reference_number":"EMA/CHMP/342584/2010","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-coordination-group_en.pdf"},
    {"id":"12286","name":"Committee on herbal medicinal products (HMPC): Meeting report, 11-12 May 2006","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-06-13T02:00:00Z","last_updated_date":"2006-06-13T02:00:00Z","reference_number":"EMEA/HMPC/183469/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-11-12-may-2006_en.pdf"},
    {"id":"12287","name":"Minutes - Annual Patients/Consumers Working Party (PCWP) and Healthcare Professionals Working Group (HCP WG) joint meeting, 16 June 2011","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2011-08-22T02:00:00Z","last_updated_date":"2011-08-22T02:00:00Z","reference_number":"EMA/613261/2011","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-annual-patientsconsumers-working-party-pcwp-and-healthcare-professionals-working-group-hcp-wg-joint-meeting-16-june-2011_en.pdf"},
    {"id":"12288","name":"Withdrawal assessment report for Tysabri","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-08-20T02:00:00Z","last_updated_date":"2013-08-20T02:00:00Z","reference_number":"EMA/492191/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tysabri_en.pdf"},
    {"id":"12289","name":"Highlights from the fourth European Medicines Agency industry platform meeting held on the 3rd of July 2017 on the operation of the centralised procedure for human medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T11:00:00Z","last_updated_date":"2017-10-31T11:00:00Z","reference_number":"EMA/424893/2017","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-fourth-european-medicines-agency-industry-platform-meeting-held-3rd-july-2017-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"12290","name":"Committee for medicinal products for human use, summary of positive opinion for Pelzont","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/197000/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-pelzont_en.pdf"},
    {"id":"12292","name":"Virola sebifera: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/604/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/virola-sebifera-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12294","name":"Presentation - Model based dose finding: discussion of presentations given by Bjà¶rn Bornkamp and Andrew Hooker (Norbert Benda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-model-based-dose-finding-discussion-presentations-given-bjaprn-bornkamp-and-andrew-hooker-norbert-benda_en.pdf"},
    {"id":"12295","name":"Presentation - Health-based exposure limits and Q&As (G. McKilligan, MHRA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-health-based-exposure-limits-and-qas-g-mckilligan-mhra_en.pdf"},
    {"id":"12296","name":"EMEA 2010 Priorities for Drug Safety Research: Long term adverse effects of immunomodulators","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-08-04T02:00:00Z","last_updated_date":"2009-08-04T02:00:00Z","reference_number":"EMEA/493705/2009","document_url":"https://www.ema.europa.eu/en/documents/other/emea-2010-priorities-drug-safety-research-long-term-adverse-effects-immunomodulators_en.pdf"},
    {"id":"12297","name":"Agenda - EMEA/ICH Workshop on Viral/Vector Shedding","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-emeaich-workshop-viralvector-shedding_en.pdf"},
    {"id":"12299","name":"CVMP post-authorisation summary of positive opinion for Panacur AquaSol","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"EMA/CVMP/732988/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-panacur-aquasol_en.pdf"},
    {"id":"12301","name":"Presentation - 1.5 Patient perspective (Christine Laver)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-15-patient-perspective-christine-laver_en.pdf"},
    {"id":"12303","name":"Presentation: Paediatric specific and ethics issues related to implementation of Clinical Trial Regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-specific-and-ethics-issues-related-implementation-clinical-trial-regulation_en.pdf"},
    {"id":"12304","name":"Reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2012-03-09T17:00:00Z","reference_number":"EMEA/HMPC/326440/2007","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-reasons-and-timelines-revision-final-community-herbal-monographs-and-community-list-entries_en.pdf"},
    {"id":"12305","name":"European Medicines Agency preparations for the impact of the 2012 Olympic Games","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T11:30:00Z","last_updated_date":"2011-12-20T11:30:00Z","reference_number":"EMA/876327/2011","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-preparations-impact-2012-olympic-games_en.pdf"},
    {"id":"12306","name":"Public statement on Infanrix Penta: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-07-10T17:00:00Z","last_updated_date":"2013-07-10T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-infanrix-penta-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"12308","name":"Citalopram: List of nationally authorised medicinal products - PSUSA/00000779/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T17:10:00Z","last_updated_date":"2017-09-06T17:10:00Z","reference_number":"EMA/583896/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/citalopram-list-nationally-authorised-medicinal-products-psusa00000779201612_en.pdf"},
    {"id":"12309","name":"Implementation plan for regulatory co-operation on medicinal products April 2, 2009 - Following the exchange of letters between the EU (EC and EMEA) and Health Canada (HPFB)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-08T02:09:21Z","last_updated_date":"2009-04-08T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/implementation-plan-regulatory-co-operation-medicinal-products-april-2-2009-following-exchange-letters-between-eu-ec-and-emea-and-health-canada-hpfb_en.pdf","translations":{"fr":"https://www.ema.europa.eu/fr/documents/other/implementation-plan-regulatory-co-operation-medicinal-products-april-2-2009-following-exchange-letters-between-eu-ec-and-emea-and-health-canada-hpfb_fr.pdf"}},
    {"id":"12310","name":"EU/3/15/1519: Public summary of opinion on orphan designation: Allogeneic human adult stem cells, isolated from skeletal muscle and expanded ex vivo for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/426687/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151519-public-summary-opinion-orphan-designation-allogeneic-human-adult-stem-cells-isolated-skeletal-muscle-and-expanded-ex-vivo-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"12311","name":"Orlistat - Article 31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T17:30:00Z","last_updated_date":"2012-12-21T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/orlistat-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/orlistat-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/orlistat-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/orlistat-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/orlistat-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/orlistat-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/orlistat-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/orlistat-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/orlistat-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/orlistat-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/orlistat-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/orlistat-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/orlistat-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/orlistat-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/orlistat-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/orlistat-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/orlistat-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/orlistat-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/orlistat-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/orlistat-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/orlistat-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/orlistat-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"12314","name":"Final community herbal monograph on Foeniculum vulgare Miller subsp.\n\nvulgare var. vulgare, aetheroleum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2007-07-05T02:00:00Z","reference_number":"EMEA/HMPC/263292/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-foeniculum-vulgare-miller-subsp-vulgare-var-vulgare-aetheroleum_en.pdf"},
    {"id":"12315","name":"Lactose of bovine origin Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-09-04T02:00:00Z","last_updated_date":"2017-09-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lactose-bovine-origin-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"12316","name":"Opinion of the HMPC on a Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2016-06-09T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"EMA/HMPC/244307/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"12318","name":"Committee for medicinal products for human use, summary of positive opinion for Nplate","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"EMEA/CHMP/571877/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-nplate_en.pdf"},
    {"id":"12319","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n17-20 November 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-21T00:09:21Z","last_updated_date":"2008-11-21T00:09:21Z","reference_number":"EMEA/CHMP/606566/2008 corr. 2","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-17-20-november-2008_en.pdf"},
    {"id":"12320","name":"Presentation - Session 2.7: Examples of interactions - PRINTO (Nicola Ruperto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-27-examples-interactions-printo-nicola-ruperto_en.pdf"},
    {"id":"12321","name":"Presentation - Sensitivity (Leon Aarons)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sensitivity-leon-aarons_en.pdf"},
    {"id":"12322","name":"Annex IV - List of thiocolchicoside-containing medicinal products in the European Union","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2014-01-29T13:00:00Z","last_updated_date":"2019-12-12T10:23:00Z","reference_number":"EMA/48333/2014 Corr.2","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-iv-list-thiocolchicoside-containing-medicinal-products-european-union_en.pdf"},
    {"id":"12324","name":"News bulletin for small and medium-sized enterprises - Issue 4","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2008-06-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-4_en.pdf"},
    {"id":"12325","name":"Permethrin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/751/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/permethrin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12326","name":"Presentation - Workshop on patient-support programmes and market-research programmes: Reflections from the patient side (David Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T02:00:00Z","last_updated_date":"2013-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patient-support-programmes-and-market-research-programmes-reflections-patient-side-david-haerry_en.pdf"},
    {"id":"12327","name":"EU/3/16/1683: Public summary of opinion on orphan designation: Melatonin for the treatment of neonatal sepsis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/391429/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161683-public-summary-opinion-orphan-designation-melatonin-treatment-neonatal-sepsis_en.pdf"},
    {"id":"12330","name":"EU/3/06/381: Public summary of positive opinion for orphan designation of\n\nhuman monoclonal antibody against Pseudomonas aeruginosa serotype O11\n\nfor the treatment of pneumonia caused by serotype O11 Pseudomonas aerugino...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMEA/COMP/428324/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306381-public-summary-positive-opinion-orphan-designation-human-monoclonal-antibody-against-pseudomonas-aeruginosa-serotype-o11-treatment-pneumonia-caused-serotype-o11-pseudomonas-aerugino_en.pdf"},
    {"id":"12331","name":"Presentation - Virtual interaction with real patients (Alessia Daturi, Paolo Avesani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-virtual-interaction-real-patients-alessia-daturi-paolo-avesani_en.pdf"},
    {"id":"12333","name":"Presentation - Discussion of legal consequences of reporting for healthcare professionals (Carlos Maria Romeo-Casabona)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-discussion-legal-consequences-reporting-healthcare-professionals-carlos-maria-romeo-casabona_en.pdf"},
    {"id":"12336","name":"Presentation - Experience from the Phagorburn clinical trial (Jerome Gabard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-phagorburn-clinical-trial-jerome-gabard_en.pdf"},
    {"id":"12337","name":"Tilmicosin (extension to chicken): Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-03-01T00:09:21Z","last_updated_date":"1998-03-01T00:09:21Z","reference_number":"EMEA/MRL/390/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tilmicosin-extension-chicken-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12338","name":"Planning for the implementation of the new legislation on pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-20T01:31:00Z","last_updated_date":"2011-04-20T01:31:00Z","reference_number":"EMA/58716/2011","document_url":"https://www.ema.europa.eu/en/documents/other/planning-implementation-new-legislation-pharmacovigilance_en.pdf"},
    {"id":"12339","name":"Presentation - Measuring impact: a review of survey studies to evaluate the effectiveness of additional risk minimisation measures in Europe (Nawab Qizilbash)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-measuring-impact-review-survey-studies-evaluate-effectiveness-additional-risk-minimisation-measures-europe-nawab-qizilbash_en.pdf"},
    {"id":"12340","name":"Presentation - New pharmacovigilance legislation: focus on first year of operation (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-pharmacovigilance-legislation-focus-first-year-operation-peter-arlett_en.pdf"},
    {"id":"12341","name":"Presentation - The Pharmacovigilance Risk Assessment Committee mandate, composition and tasks (R. De Lisa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-risk-assessment-committee-mandate-composition-and-tasks-r-de-lisa_en.pdf"},
    {"id":"12342","name":"GVK Biosciences Article-31 referral - GVK Biosciences: Final assessment report following the re-examination procedure","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-08-04T02:00:00Z","last_updated_date":"2015-08-04T02:00:00Z","reference_number":"EMA/348074/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-gvk-biosciences-final-assessment-report-following-re-examination-procedure_en.pdf"},
    {"id":"12343","name":"Committee for Advanced Therapies (CAT): July 2009 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-22T02:00:00Z","last_updated_date":"2009-07-22T02:00:00Z","reference_number":"EMEA/CAT/442707/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-july-2009-meeting-monthly-report_en.pdf"},
    {"id":"12345","name":"Technical specifications - Annex IX costig scenario: Procurement procedure EMA/2013/30/IS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-14T02:00:00Z","last_updated_date":"2014-04-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-ix-costig-scenario-procurement-procedure-ema201330is_en.xls"},
    {"id":"12347","name":"Presentation - Discussion of multiplicity corrections in bioequivalence trials (Thomas Lang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-discussion-multiplicity-corrections-bioequivalence-trials-thomas-lang_en.pdf"},
    {"id":"12350","name":"Gadoteridol: CMDh scientific conclusions and grounds for the variation,\n\namendments to the product information, and timetable\n\nfor the implementation - PSUSA/00001507/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T01:00:00Z","last_updated_date":"2016-10-18T16:56:39Z","reference_number":"EMA/186716/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteridol-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001507201504_en.pdf"},
    {"id":"12351","name":"Final assessment report on Echinacea purpurea (L.) Moench., herba recens","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-04-13T02:00:00Z","last_updated_date":"2015-04-13T02:00:00Z","reference_number":"EMA/HMPC/557979/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"12354","name":"EU/3/15/1536: Public summary of opinion on orphan designation: Recombinant human acid ceramidase for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/500571/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151536-public-summary-opinion-orphan-designation-recombinant-human-acid-ceramidase-treatment-cystic-fibrosis_en.pdf"},
    {"id":"12355","name":"Presentation - 6.6 Innovative designs pharmacometrics and optimal designs (Joe Standing)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-66-innovative-designs-pharmacometrics-and-optimal-designs-joe-standing_en.pdf"},
    {"id":"12356","name":"EU/3/05/265: Public summary of positive opinion for orphan designation of ciclosporin (inhalation use) for treatment of graft rejection after lung transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T00:00:00Z","last_updated_date":"2016-10-22T01:00:00Z","reference_number":"EMEA/COMP/42154/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305265-public-summary-positive-opinion-orphan-designation-ciclosporin-inhalation-use-treatment-graft-rejection-after-lung-transplantation_en.pdf"},
    {"id":"12357","name":"Agenda - 6th ICH E2B (R3) Individual Case Safety Report (ICSR) information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-03-25T01:00:00Z","last_updated_date":"2014-03-25T01:00:00Z","reference_number":"Course #14502","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-6th-ich-e2b-r3-individual-case-safety-report-icsr-information-day_en.pdf"},
    {"id":"12358","name":"Results of the sampling and testing programme for the year 2009","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-08-10T02:00:00Z","last_updated_date":"2010-12-14T01:00:00Z","reference_number":"EMA/INS/S&T/477571/2010","document_url":"https://www.ema.europa.eu/en/documents/report/results-sampling-and-testing-programme-year-2009_en.pdf"},
    {"id":"12361","name":"Overview of comments received on 'Draft guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-03-23T01:00:00Z","last_updated_date":"2016-03-23T01:00:00Z","reference_number":"EMA/129183/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-treatment-venous-thromboembolic-disease_en.pdf"},
    {"id":"12363","name":"Presentation - Packaging and labelling (Johann M. Lenhardsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-packaging-and-labelling-johann-m-lenhardsson_en.pdf"},
    {"id":"12364","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the October 2010 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-10-12T02:00:00Z","last_updated_date":"2010-10-12T02:00:00Z","reference_number":"EMA/COMP/586816/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-october-2010-meeting_en.pdf"},
    {"id":"12365","name":"Biological medicinal products","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2016-11-08T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/biological-medicinal-products_en.pdf"},
    {"id":"12368","name":"PDCO meeting highlights 26-28 September 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-10-01T02:00:00Z","last_updated_date":"2007-10-01T02:00:00Z","reference_number":"EMEA/440694/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-26-28-september-2007_en.pdf"},
    {"id":"12370","name":"CVMP summary of positive opinion for Zulvac 1+8 Ovis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-01-14T01:00:00Z","last_updated_date":"2011-01-14T01:00:00Z","reference_number":"EMA/CVMP/295355/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-zulvac-18-ovis_en.pdf"},
    {"id":"12371","name":"Presentation - EudraVigilance and signal detection","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-and-signal-detection_en.pdf"},
    {"id":"12373","name":"EU/3/17/1869: Public summary of opinion on orphan designation: Rituximab for treatment in solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/203464/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171869-public-summary-opinion-orphan-designation-rituximab-treatment-solid-organ-transplantation_en.pdf"},
    {"id":"12374","name":"Standard Operating Procedure for MRL Procedure: Submission of Dossiers to the Members of the Committee for Veterinary Medicinal Products","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-12-10T01:00:00Z","last_updated_date":"2007-12-10T01:00:00Z","reference_number":"EMEA/CVMP/819/99-Annex 1","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-mrl-procedure-submission-dossiers-members-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12376","name":"Questions - Meeting of the Paediatric Diabetes Mellitus Experts Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-06T02:00:00Z","last_updated_date":"2010-05-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-meeting-paediatric-diabetes-mellitus-experts-group_en.pdf"},
    {"id":"12377","name":"Presentation - Session 4 : Pharmacogenomics-guided treatments in clinical care: experience from patients and healthcare professionals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-pharmacogenomics-guided-treatments-clinical-care-experience-patients-and-healthcare-professionals_en.pdf"},
    {"id":"12379","name":"Human prothrombin complex: List of nationally authorised medicinal products - PSUSA/00001638/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-24T11:30:00Z","last_updated_date":"2017-01-24T11:37:34Z","reference_number":"EMA/45481/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-prothrombin-complex-list-nationally-authorised-medicinal-products-psusa00001638201604_en.pdf"},
    {"id":"12382","name":"Questions and answers on the recommendation for refusal of a marketing authorisation application for Veraflox","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-veraflox_sv.pdf"}},
    {"id":"12383","name":"Report on the implementation of the European Medicines Agency/Committee for Medicinal Products for Human Use think-tank recommendations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-09-28T13:15:00Z","last_updated_date":"2011-09-28T13:15:00Z","reference_number":"EMA/585687/2010","document_url":"https://www.ema.europa.eu/en/documents/report/report-implementation-european-medicines-agencycommittee-medicinal-products-human-use-think-tank-recommendations_en.pdf"},
    {"id":"12384","name":"Presentation - Why are rare diseases of interest to industry (Brihad Abhyankar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-why-are-rare-diseases-interest-industry-brihad-abhyankar_en.pdf"},
    {"id":"12386","name":"Letter of invitation for service concession - Procurement procedure EMA/2014/35/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T15:00:00Z","last_updated_date":"2015-02-23T15:00:00Z","reference_number":"EMA/47128/2015","document_url":"https://www.ema.europa.eu/en/documents/procurement/letter-invitation-service-concession-procurement-procedure-ema201435re_en.pdf"},
    {"id":"12387","name":"EU/3/08/596: Public summary of positive opinion for orphan designation of monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for the treatment of Hodgkin lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMEA/COMP/547302/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308596-public-summary-positive-opinion-orphan-designation-monoclonal-antibody-against-human-cd30-covalently-linked-cytotoxin-monomethylauristatin-e-treatment-hodgkin-lymphoma_en.pdf"},
    {"id":"12389","name":"Agenda - Workshop on access to clinical-trial data and transparency","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T17:13:02Z","last_updated_date":"2012-11-22T11:57:00Z","reference_number":"EMA/406355/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-access-clinical-trial-data-and-transparency_en.pdf"},
    {"id":"12391","name":"Zinbryta Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T01:00:00Z","last_updated_date":"2018-03-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"12392","name":"EU/3/08/553: Public summary of positive opinion for orphan designation of recombinant fusion protein of circularly-permuted IL-4 and pseudomonas exotoxin A, [IL-4(38-37)-PE38KDEL] for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2008-08-18T02:00:00Z","reference_number":"EMEA/COMP/202184/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308553-public-summary-positive-opinion-orphan-designation-recombinant-fusion-protein-circularly-permuted-il-4-and-pseudomonas-exotoxin-il-438-37-pe38kdel-treatment-glioma_en.pdf"},
    {"id":"12393","name":"No evidence that Fluad vaccine caused deaths in Italy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-03T18:00:00Z","last_updated_date":"2014-12-03T18:00:00Z","reference_number":"EMA/749142/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/no-evidence-fluad-vaccine-caused-deaths-italy_en.pdf"},
    {"id":"12394","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2004 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2004-10-18T02:00:00Z","last_updated_date":"2004-10-18T02:00:00Z","reference_number":"EMEA/CHMP/1214/04","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2004-plenary-meeting-monthly-report_en.pdf"},
    {"id":"12396","name":"Semler Article-31 referral – Annex IA  and IB","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-03T12:00:00Z","last_updated_date":"2016-11-17T15:00:00Z","reference_number":"EMA/314147/2016 Corr. 6","document_url":"https://www.ema.europa.eu/en/documents/referral/semler-article-31-referral-annex-ia-and-ib_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/semler-article-31-referral-annex-ia-and-ib_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/semler-article-31-referral-annex-ia-and-ib_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/semler-article-31-referral-annex-ia-and-ib_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/semler-article-31-referral-annex-ia-and-ib_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/semler-article-31-referral-annex-ia-and-ib_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/semler-article-31-referral-annex-ia-and-ib_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/semler-article-31-referral-annex-ia-and-ib_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/semler-article-31-referral-annex-ia-and-ib_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/semler-article-31-referral-annex-ia-and-ib_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/semler-article-31-referral-annex-ia-and-ib_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/semler-article-31-referral-annex-ia-and-ib_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/semler-article-31-referral-annex-ia-and-ib_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/semler-article-31-referral-annex-ia-and-ib_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/semler-article-31-referral-annex-ia-and-ib_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/semler-article-31-referral-annex-ia-and-ib_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/semler-article-31-referral-annex-ia-and-ib_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/semler-article-31-referral-annex-ia-and-ib_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/semler-article-31-referral-annex-ia-and-ib_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/semler-article-31-referral-annex-ia-and-ib_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/semler-article-31-referral-annex-ia-and-ib_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/semler-article-31-referral-annex-ia-and-ib_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/semler-article-31-referral-annex-ia-and-ib_sv.pdf"}},
    {"id":"12397","name":"CHMP summary of positive opinion for Amglidia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-02-23T01:00:00Z","reference_number":"EMA/102426/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-amglidia_en.pdf"},
    {"id":"12398","name":"Extension (Annex II) applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-25T01:09:21Z","last_updated_date":"2009-12-03T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/extension-annex-ii-applications_en.pdf"},
    {"id":"12400","name":"EU/3/13/1110: Public summary of opinion on orphan designation:\n\nRecombinant human heat-shock protein 70 for the treatment of Niemann-Pick’s disease type C","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-05T02:00:00Z","last_updated_date":"2017-08-14T02:00:00Z","reference_number":"EMA/COMP/105680/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131110-public-summary-opinion-orphan-designation-recombinant-human-heat-shock-protein-70-treatment-niemann-picks-disease-type-c_en.pdf"},
    {"id":"12402","name":"Presentation: Involvement of children - iCAN","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involvement-children-ican_en.pdf"},
    {"id":"12404","name":"Practical considerations on the impact of the new pharmaceutical legislation on marketing authorisation applications via the centralised procedure and centrally authorised products for human use","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-05-03T02:00:00Z","last_updated_date":"2006-05-03T02:00:00Z","reference_number":"EMEA/243280/2005 – Rev 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-considerations-impact-new-pharmaceutical-legislation-marketing-authorisation-applications-centralised-procedure-and-centrally-authorised-products-human-use_en.pdf"},
    {"id":"12405","name":"CHMP post-authorisation summary of positive opinion for Stelara","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-01-24T01:00:00Z","reference_number":"EMA/CHMP/20129/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stelara_en.pdf-0"},
    {"id":"12406","name":"Superseded overview of comments received on Community herbal monograph on Echinacea purpurea (L.) Moench, radix - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-02-10T01:00:00Z","last_updated_date":"2011-02-10T01:00:00Z","reference_number":"EMA/HMPC/7084/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-echinacea-purpurea-l-moench-radix-first-version_en.pdf"},
    {"id":"12407","name":"Presentation - European Medicines Agency Adaptive Pathways Pilot presentation at the Safe and Timely Access to Medicines for Patients (STAMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-20T11:00:00Z","last_updated_date":"2015-11-20T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-adaptive-pathways-pilot-presentation-safe-and-timely-access-medicines-patients-stamp_en.pdf"},
    {"id":"12409","name":"Presentation - Module 5 - Clinical trials in the European Union","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-5-clinical-trials-european-union_en.pdf"},
    {"id":"12411","name":"EU/3/14/1274: Public summary of opinion on orphan designation of paclitaxel-succinate-Arg-Arg-Leu-Ser-Tyr-Ser-Arg-Arg-Arg-Phe for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMA/COMP/252166/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141274-public-summary-opinion-orphan-designation-paclitaxel-succinate-arg-arg-leu-ser-tyr-ser-arg-arg-arg-phe-treatment-glioma_en.pdf"},
    {"id":"12412","name":"CHMP post-authorisation summary of positive opinion for Thyrogen","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2012-10-19T14:30:00Z","reference_number":"EMA/CHMP/667825/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-thyrogen_en.pdf-0"},
    {"id":"12415","name":"Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-01-03T18:27:00Z","last_updated_date":"2017-01-03T18:27:00Z","reference_number":"EMA/CVMP/SWP/66781/2005–Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-safety-and-residue-data-requirements-pharmaceutical-veterinary-medicinal-products-intended-minor-use-or-minor-species-mumslimited-market_en.pdf"},
    {"id":"12416","name":"Bromocriptine, Dihydroergocryptine and Lisuride - Article 31 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-05-05T02:08:21Z","last_updated_date":"2009-05-05T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bromocriptine-dihydroergocryptine-and-lisuride-article-31-referral-annex-i_sv.pdf"}},
    {"id":"12421","name":"Florfenicol (Extension to chicken): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/589/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/florfenicol-extension-chicken-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12422","name":"Zinbryta Article-20 referral - Assessment report on provisional measures","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-07-19T18:23:00Z","last_updated_date":"2017-09-01T16:55:00Z","reference_number":"EMA/453660/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-assessment-report-provisional-measures_en.pdf"},
    {"id":"12423","name":"Presentation - European Surveillance of Veterinary Antimicrobial Consumption data on consumption of veterinary antimicrobial agents in 2010 from 19 European Union / European Economic Area countries (Kari Grave, Arno Mull...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T13:00:00Z","last_updated_date":"2013-04-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-surveillance-veterinary-antimicrobial-consumption-data-consumption-veterinary-antimicrobial-agents-2010-19-european-union-european-economic-area-countries-kari-grave-arno-mull_en.pdf"},
    {"id":"12425","name":"Role of the European Commission, S Atzor, EC","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/role-european-commission-s-atzor-ec_en.pdf"},
    {"id":"12427","name":"Concept paper on the development of a CHMP guideline on clinical investigation of immunosuppressants for solid organ transplantation","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"CHMP/EWP/263148/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-chmp-guideline-clinical-investigation-immunosuppressants-solid-organ-transplantation_en.pdf"},
    {"id":"12428","name":"Pimecrolimus: List of nationally authorised medicinal products - PSUSA/00002411/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T19:00:00Z","last_updated_date":"2017-10-27T19:00:00Z","reference_number":"EMA/716745/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/pimecrolimus-list-nationally-authorised-medicinal-products-psusa00002411201703_en.pdf"},
    {"id":"12429","name":"CHMP summary of positive opinion for Memantine ratiopharm","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T13:00:00Z","last_updated_date":"2013-03-22T13:00:00Z","reference_number":"EMA/CHMP/157191/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-memantine-ratiopharm_en.pdf"},
    {"id":"12430","name":"Presentation - Vaccine acceptance or refusal? Individual choice vs societal needs or my risks vs 'our' risks (Heidi Larson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-vaccine-acceptance-or-refusal-individual-choice-vs-societal-needs-or-my-risks-vs-our-risks-heidi-larson_en.pdf"},
    {"id":"12431","name":"Designated Medical Event (DME) list","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-08-18T19:00:00Z","last_updated_date":"2020-06-16T12:40:00Z","reference_number":"EMA/326038/2020","document_url":"https://www.ema.europa.eu/en/documents/other/designated-medical-event-dme-list_en.xlsx"},
    {"id":"12436","name":"Opinions on safety variations adopted at the CHMP meeting 14-17 January 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-25T15:56:00Z","last_updated_date":"2013-01-25T15:56:00Z","reference_number":"EMA/28123/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-chmp-meeting-14-17-january-2013_en.pdf"},
    {"id":"12437","name":"CHMP summary of positive opinion for NovoRapid","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/CHMP/606776/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-summary-positive-opinion-novorapid_en.pdf"},
    {"id":"12439","name":"Paediatric European Network for Treatment of AIDS (PENTA) since 1993 - Dr Carlo Giaquinto","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/paediatric-european-network-treatment-aids-penta-1993-dr-carlo-giaquinto_en.pdf"},
    {"id":"12440","name":"CHMP post-authorisation summary of positive opinion for Nplate","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"EMA/CHMP/738145/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-nplate_en.pdf"},
    {"id":"12441","name":"EU/3/13/1119: Public summary of opinion on orphan designation: Lenvatinib for the treatment of follicular thyroid cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-05-14T12:00:00Z","last_updated_date":"2013-10-22T12:00:00Z","reference_number":"EMA/COMP/193931/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131119-public-summary-opinion-orphan-designation-lenvatinib-treatment-follicular-thyroid-cancer_en.pdf"},
    {"id":"12442","name":"Superseded final assessment report on Tanacetum parthenium (L.) Schulz Bip., herba -First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-06-20T02:00:00Z","last_updated_date":"2020-08-14T02:00:00Z","reference_number":"EMA/HMPC/587579/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-final-assessment-report-tanacetum-parthenium-l-schulz-bip-herba-first-version_en.pdf"},
    {"id":"12448","name":"Guidelines and concept papers - Adopted during the CHMP meeting 18-21 June 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T11:33:00Z","last_updated_date":"2012-06-25T11:33:00Z","reference_number":"EMA/CHMP/410509/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-18-21-june-2012_en.pdf"},
    {"id":"12449","name":"Presentation - Capturing added value in immuno-oncology: balancing rapid access and new metrics for valuation (Patrick Hopkinson) - S6.2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-capturing-added-value-immuno-oncology-balancing-rapid-access-and-new-metrics-valuation-patrick-hopkinson-s62_en.pdf"},
    {"id":"12450","name":"Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-10-25T02:08:21Z","last_updated_date":"2007-10-25T02:08:21Z","reference_number":"EMEA/CHMP/350251/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-294-referral-xeomin-international-non-proprietary-name-inn-clostridium-botulinum-neurotoxin-type-background-information_sv.pdf"}},
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    {"id":"12453","name":"CHMP summary of positive opinion for Busulfan Fresenius Kabi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/388260/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-busulfan-fresenius-kabi_en.pdf"},
    {"id":"12456","name":"Minutes of the seventh meeting of the EMEA Human Scientific Committees’ Working Party with with Patients’ and Consumers’ Organisations (PCWP)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/595521/08","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-seventh-meeting-emea-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp_en.pdf"},
    {"id":"12459","name":"Presentation - Summaries of risk management plan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summaries-risk-management-plan_en.pdf"},
    {"id":"12460","name":"Presentation - An adaptive dose-finding study in postoperative dental pain. MCP-Mod (Bjà¶rn Bornkamp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adaptive-dose-finding-study-postoperative-dental-pain-mcp-mod-bjaprn-bornkamp_en.pdf"},
    {"id":"12461","name":"GxP inspections within the centralised procedure - Brendan Cuddy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/gxp-inspections-within-centralised-procedure-brendan-cuddy_en.pdf-0"},
    {"id":"12465","name":"Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and ...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-03-29T02:09:21Z","last_updated_date":"2004-03-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/commission-directive-200561ec-30-september-2005-implementing-directive-200298ec-european-parliament-and-council-regards-traceability-requirements-and-notification-serious-adverse-reactions-and_en.pdf"},
    {"id":"12467","name":"EU/3/12/982: Public summary of opinion on orphan designation: Dipalmitoylphosphatidylcholine, 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol, sodium salt, synthetic surfactant protein C analogue and synthetic surfacta...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-04-30T02:00:00Z","reference_number":"EMA/COMP/135935/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312982-public-summary-opinion-orphan-designation-dipalmitoylphosphatidylcholine-1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol-sodium-salt-synthetic-surfactant-protein-c-analogue-and-synthetic_en.pdf"},
    {"id":"12468","name":"Terazosin: List of nationally authorised medicinal products: PSUSA/00002895/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T12:00:00Z","last_updated_date":"2016-10-19T12:14:37Z","reference_number":"EMA/437334/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/terazosin-list-nationally-authorised-medicinal-products-psusa00002895201511_en.pdf"},
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    {"id":"12510","name":"Rare metabolic diseases, the miglusat experience: Fran Pratt","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/rare-metabolic-diseases-miglusat-experience-fran-pratt_en.pdf"},
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    {"id":"12523","name":"ENCePP Scientific Convention - EU health care databases for pan-EU research - List of participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-12-08T01:00:00Z","last_updated_date":"2008-12-08T01:00:00Z","reference_number":"EMEA/657313/2008","document_url":"https://www.ema.europa.eu/en/documents/other/encepp-scientific-convention-eu-health-care-databases-pan-eu-research-list-participants_en.pdf"},
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    {"id":"12526","name":"Mandate, objectives and rules of procedure for the CVMP Ad Hoc Group on Novel Veterinary Therapies","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-19T14:30:00Z","last_updated_date":"2014-06-19T14:30:00Z","reference_number":"EMA/CVMP/139369/2014 Endorsed","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-cvmp-ad-hoc-group-novel-veterinary-therapies_en.pdf"},
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    {"id":"12541","name":"EU/3/09/709: Public summary of opinion on orphan designation of recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T00:09:21Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"EMA/COMP/728150/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309709-public-summary-opinion-orphan-designation-recombinant-fusion-protein-consisting-extracellular-portion-cd95-fused-fc-part-human-igg1-molecule-treatment-glioma_en.pdf"},
    {"id":"12542","name":"Opinion of the HMPC on a Community herbal monograph on Cichorium intybus L., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-14T16:00:00Z","last_updated_date":"2013-03-14T16:00:00Z","reference_number":"EMA/HMPC/M/H/0126","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-cichorium-intybus-l-radix_en.pdf"},
    {"id":"12543","name":"EU/3/07/511: Public summary of positive opinion for orphan designation of3-methoxy-pregnenolone for the treatment of spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2008-07-02T02:00:00Z","reference_number":"EMEA/COMP/473266/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307511-public-summary-positive-opinion-orphan-designation-of3-methoxy-pregnenolone-treatment-spinal-cord-injury_en.pdf"},
    {"id":"12544","name":"Outlines of amendments to the Extended EudraVigilance Medicinal Product Report Message (XEVPRM) schema and EVWEB Labels","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T18:00:00Z","last_updated_date":"2014-01-31T18:00:00Z","reference_number":"EMA/21088/2014","document_url":"https://www.ema.europa.eu/en/documents/other/outlines-amendments-extended-eudravigilance-medicinal-product-report-message-xevprm-schema-and-evweb-labels_en.pdf"},
    {"id":"12546","name":"News bulletin for small and medium-sized enterprises - Issue 38","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T16:38:00Z","last_updated_date":"2017-02-02T16:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-38_en.pdf"},
    {"id":"12547","name":"Etamiphylline camsylate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-04-01T02:00:00Z","last_updated_date":"1996-04-01T02:00:00Z","reference_number":"EMEA/MRL/085/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/etamiphylline-camsylate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12550","name":"Presentation - Benefit-risk communication: perspective from PRAC (June Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-benefit-risk-communication-perspective-prac-june-raine_en.pdf"},
    {"id":"12552","name":"CHMP post-authorisation summary of positive opinion for Tivicay","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/CHMP/816690/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tivicay_en.pdf"},
    {"id":"12553","name":"Closer ties on medicines safety between European and Canadian regulatory authorities","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-01-11T01:00:00Z","last_updated_date":"2008-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/closer-ties-medicines-safety-between-european-and-canadian-regulatory-authorities_en.pdf"},
    {"id":"12557","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T16:50:00Z","last_updated_date":"2015-11-12T16:50:00Z","reference_number":"EMA/666595/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-october-2015_en.pdf"},
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    {"id":"12603","name":"Brief summary of the existing systems on collecting data: The Czech Republic","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-czech-republic_en.pdf"},
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    {"id":"12626","name":"Almitrine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/759665/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-referral-annex-i_en.pdf-0"},
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    {"id":"12628","name":"P/60/2008: European Medicines Agency decision of 8 September 2009: on a class waiver on a class of medicinal products in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council as amend...","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-09-08T02:09:21Z","last_updated_date":"2008-09-08T02:09:21Z","reference_number":"EMEA/386453/2008","document_url":"https://www.ema.europa.eu/en/documents/other/p602008-european-medicines-agency-decision-8-september-2009-class-waiver-class-medicinal-products-accordance-regulation-ec-no-19012006-european-parliament-and-council-amend_en.pdf"},
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    {"id":"12694","name":"BioPartners GmbH withdraws its application for Biferonex (interferon beta-1a)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/333052/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/biopartners-gmbh-withdraws-its-application-biferonex-interferon-beta-1a_en.pdf"},
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    {"id":"12704","name":"Appointment of new Accounting Officer of the European Medicines Agency","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"EMA/MB/124276/2012","document_url":"https://www.ema.europa.eu/en/documents/other/appointment-new-accounting-officer-european-medicines-agency_en.pdf"},
    {"id":"12706","name":"Presentation - Revision 2 of CVMP guideline: conduct of bioequivalence studies for veterinary medicinal products - Main changes to the guideline","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-06T02:09:00Z","last_updated_date":"2009-05-06T02:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revision-2-cvmp-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-main-changes-guideline_en.pdf"},
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    {"id":"12712","name":"EU/3/04/227: Public summary of  positive opinion for orphan designation  of  l, 1'-[1,4-phenylenebis (methylene)]-bis-1,4,8,11- tetraazacyclotetradecane  for treatment to mobilize progenitor cells prior to stem cell tran...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2021-08-10T12:24:00Z","reference_number":"EMEA/COMP/77477/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304227-public-summary-positive-opinion-orphan-designation-l-1-14-phenylenebis-methylene-bis-14811-tetraazacyclotetradecane-treatment-mobilize-progenitor-cells-prior-stem-cell-tran_en.pdf"},
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    {"id":"12728","name":"Overview of comments received on 'Reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products' (EMA/CVMP/ERAWP/409328/2010)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-15T16:30:00Z","last_updated_date":"2012-03-15T16:30:00Z","reference_number":"EMA/CVMP/ERA/737515/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-risk-mitigation-measures-related-environmental-risk-assessment-veterinary-medicinal-products-emacvmperawp4093282010_en.pdf"},
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    {"id":"12772","name":"Presentation - Data exploration at the speed of thought: lessons learned from inside Google (Nico Gaviola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-exploration-speed-thought-lessons-learned-inside-google-nico-gaviola_en.pdf"},
    {"id":"12773","name":"Presentation - Enpr-EMA collaboration with PDCO (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-collaboration-pdco-irmgard-eichler_en.pdf"},
    {"id":"12775","name":"Questions and answers on the referral for Pantoprazole Bluefish pantoprazole 20 and 40 mg tablets","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-11-21T00:59:00Z","last_updated_date":"2011-03-09T00:59:00Z","reference_number":"EMEA/CHMP/734816/2009 Rev","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-pantoprazole-bluefish-pantoprazole-20-and-40-mg-tablets_sv.pdf"}},
    {"id":"12777","name":"Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/0010299/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T01:00:00Z","last_updated_date":"2016-10-17T18:39:12Z","reference_number":"EMA/830034/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-prepared-cell-cultures-list-nationally-authorised-medicinal-products-psusa0010299201504_en.pdf"},
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    {"id":"12780","name":"Neurochem withdraws its marketing authorisation application for\n\nKiacta (eprodisate disodium)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-17T01:00:00Z","last_updated_date":"2008-03-17T01:00:00Z","reference_number":"EMEA/137989/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/neurochem-withdraws-its-marketing-authorisation-application-kiacta-eprodisate-disodium_en.pdf"},
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    {"id":"12784","name":"EMA seeks views of public during its safety review of valproate","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-07-11T14:00:00Z","last_updated_date":"2017-07-11T14:00:00Z","reference_number":"EMA/423957/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-seeks-views-public-during-its-safety-review-valproate_en.pdf"},
    {"id":"12785","name":"Presentation - Communication to patients, consumers and healthcare professionals (Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-patients-consumers-and-healthcare-professionals-juan-garcia-burgos_en.pdf"},
    {"id":"12786","name":"EU/3/12/983: Public summary of opinion on orphan designation: Heterologous human adult liver-derived stem cells for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2012-06-18T13:00:00Z","reference_number":"EMA/COMP/222564/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312983-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-stem-cells-treatment-acute-liver-failure_en.pdf"},
    {"id":"12790","name":"Adrenaline auto-injectors Article-31 referral - CHMP assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T02:00:00Z","last_updated_date":"2015-08-26T02:00:00Z","reference_number":"EMA/478468/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/adrenaline-auto-injectors-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"12791","name":"Letter from the European Medicines Agency and the European Commission to Health Canada: Confidentiality agreement details","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-15T16:30:00Z","last_updated_date":"2013-03-15T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-medicines-agency-and-european-commission-health-canada-confidentiality-agreement-details_en.pdf"},
    {"id":"12792","name":"Questions and answers on the procedure of paediatric-investigation-plan compliance verification at the European Medicines Agency, and paediatric rewards","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2015-01-21T16:15:00Z","reference_number":"EMA/PDCO/179892/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-procedure-paediatric-investigation-plan-compliance-verification-european-medicines-agency-and-paediatric-rewards_en.pdf"},
    {"id":"12795","name":"Methadone Article-107i procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-prac-list-questions_en.pdf"},
    {"id":"12797","name":"General remarks on the recommendations - Dr Frits Lekkerkerker","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-12-03T01:00:00Z","last_updated_date":"2004-12-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/general-remarks-recommendations-dr-frits-lekkerkerker_en.pdf"},
    {"id":"12798","name":"EU/3/12/965: Public summary of opinion on orphan designation: Ketoconazole for the treatment of Cushing’s syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-05-03T17:30:00Z","last_updated_date":"2015-03-12T16:30:00Z","reference_number":"EMA/COMP/66372/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312965-public-summary-opinion-orphan-designation-ketoconazole-treatment-cushings-syndrome_en.pdf"},
    {"id":"12799","name":"Superseded list of references supporting the HMPC Assessment Report on Plantago ovata Forssk., semen (EMEA/HMPC/166377/2006)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/166377/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-hmpc-assessment-report-plantago-ovata-forssk-semen-emeahmpc1663772006_en.pdf"},
    {"id":"12802","name":"CHMP summary of opinion for Neparvis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/204025/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-neparvis_en.pdf"},
    {"id":"12803","name":"Committee for Proprietary Medicinal Products (CPMP) 13th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-02-15T01:00:00Z","last_updated_date":"1996-02-15T01:00:00Z","reference_number":"CPMP/179/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-13th-plenary-meeting_en.pdf"},
    {"id":"12804","name":"Presentation - Modelling and simulation for dose adjustment in renally impaired patients - Break-out session 2 theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-dose-adjustment-renally-impaired-patients-break-out-session-2-theme-2_en.pdf"},
    {"id":"12807","name":"CVMP monthly report of application procedures, guidelines and related documents: July 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-08-08T14:45:00Z","last_updated_date":"2013-08-08T14:45:00Z","reference_number":"EMA/433049/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-july-2013_en.pdf"},
    {"id":"12813","name":"European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn’s disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/169535/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-locally-targeted-treatment-ulcerative-colitis-and-crohns-disease_en.pdf"},
    {"id":"12815","name":"CVMP summary of positive opinion for Zycortal","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-11T16:00:00Z","last_updated_date":"2015-09-11T16:00:00Z","reference_number":"EMA/CVMP/478464/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-zycortal_en.pdf"},
    {"id":"12818","name":"Agenda and registration form - EudraVigilance information day on 19 September 2017","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T16:30:00Z","last_updated_date":"2017-08-18T17:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-information-day-19-september-2017_en.pdf"},
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    {"id":"12844","name":"Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-09-05T14:30:00Z","last_updated_date":"2018-09-05T14:30:00Z","reference_number":"EMA/CVMP/698114/2017","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-porcine-prolactin_en.pdf"},
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    {"id":"12850","name":"Presentation - Challenges experienced or anticipated by other regulators and payers and proposals for dealing with them - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-experienced-or-anticipated-other-regulators-and-payers-and-proposals-dealing-them-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp_en.pdf"},
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    {"id":"12853","name":"European Medicines Agency confirms positive benefit-risk balance of pholcodine-containing cough medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-18T11:00:00Z","last_updated_date":"2011-11-18T11:00:00Z","reference_number":"EMA/CHMP/898043/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-confirms-positive-benefit-risk-balance-pholcodine-containing-cough-medicines_en.pdf"},
    {"id":"12854","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/CHMP/723042/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2010_en.pdf"},
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    {"id":"12862","name":"CHMP post-authorisation summary of positive opinion for Xultophy II/23","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-04-27T02:00:00Z","last_updated_date":"2018-04-27T02:00:00Z","reference_number":"EMA/CHMP/250993/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xultophy-ii23_en.pdf"},
    {"id":"12863","name":"European Medicines Agency sees strong level of applications in 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-10-12T02:09:21Z","last_updated_date":"2007-10-12T02:09:21Z","reference_number":"EMEA/454935/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-sees-strong-level-applications-2007_en.pdf"},
    {"id":"12864","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 9-11 September 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-09-23T11:10:00Z","last_updated_date":"2015-09-23T11:10:00Z","reference_number":"EMA/PDCO/595590/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-9-11-september-2015_en.pdf"},
    {"id":"12865","name":"Committee for Medicinal Products for Veterinary Use: Meeting of 9-11 February 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-02-12T00:09:21Z","last_updated_date":"2010-02-12T00:09:21Z","reference_number":"EMA/CVMP/54754/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-9-11-february-2010_en.pdf"},
    {"id":"12866","name":"Pholcodine - Article 31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-03-28T02:00:00Z","last_updated_date":"2012-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/pholcodine-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/pholcodine-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/pholcodine-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/pholcodine-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/pholcodine-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/pholcodine-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/pholcodine-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/pholcodine-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/pholcodine-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/pholcodine-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/pholcodine-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/pholcodine-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/pholcodine-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/pholcodine-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/pholcodine-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/pholcodine-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/pholcodine-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/pholcodine-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/pholcodine-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/pholcodine-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/pholcodine-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"12869","name":"EudraVigilance user manual -  Individual case safety report form - Version 1.1","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2018-01-22T16:00:00Z","reference_number":"EMA/249220/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-user-manual-individual-case-safety-report-form-version-11_en.pdf"},
    {"id":"12871","name":"Presentation - Nanotechnology - What about safety? How do we determine risk? Wim H de Jong, National Institute for Public Health and the Environment, Bilthoven","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nanotechnology-what-about-safety-how-do-we-determine-risk-wim-h-de-jong-national-institute-public-health-and-environment-bilthoven_en.pdf"},
    {"id":"12873","name":"EU/3/14/1389: Public summary of positive opinion for orphan designation: Adeno-associated viral vector serotype rh.rh.10 carrying the human N-sulfoglucosamine sulfohydrolase cDNA for the treatment of mucopolysaccharidosi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-05-13T19:00:00Z","reference_number":"EMA/COMP/730599/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141389-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-serotype-rhrh10-carrying-human-n-sulfoglucosamine-sulfohydrolase-cdna-treatment-mucopolysaccharidosi_en.pdf"},
    {"id":"12874","name":"European Union recommendations for the influenza-vaccine composition for the season 2004 / 2005","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-07-21T02:09:21Z","last_updated_date":"2004-07-21T02:09:21Z","reference_number":"EMEA/BWP/1104/04","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-recommendations-influenza-vaccine-composition-season-2004-2005_en.pdf"},
    {"id":"12875","name":"Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-09-21T02:00:00Z","last_updated_date":"2015-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course_en.pdf-0"},
    {"id":"12876","name":"Flupirtine Article-31 referral - Withdrawal of pain medicine flupirtine endorsed","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flupirtine-article-31-referral-withdrawal-pain-medicine-flupirtine-endorsed_sv.pdf"}},
    {"id":"12877","name":"Committee for Medicinal Products for Human Use (CHMP) - April 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-04-30T02:00:00Z","last_updated_date":"2010-05-06T02:00:00Z","reference_number":"EMA/CHMP/256110/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-april-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"12879","name":"Reflection paper: Minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-04-23T02:00:00Z","last_updated_date":"2007-04-23T02:00:00Z","reference_number":"EMEA/CVMP/IWP/105008/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-minimum-data-requirements-authorisation-under-exceptional-circumstances-vaccines-emergency-use-against-bluetongue_en.pdf"},
    {"id":"12881","name":"Presentation - French Agency for Food , Environmental and Occupational Health and safety (ANSES), The French Agency for Veterinary Medicinal Products (ANMV) - Substance, product, organisation and referential data (SPOR) ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-27T01:00:00Z","last_updated_date":"2018-02-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-french-agency-food-environmental-and-occupational-health-and-safety-anses-french-agency-veterinary-medicinal-products-anmv-substance-product-organisation-and-referential-data-spor_en.pdf"},
    {"id":"12885","name":"EU/3/09/699: Public summary of positive opinion for orphan designation of\n\nrecombinant chimeric monoclonal antibody against CD20 for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T02:09:21Z","last_updated_date":"2010-03-15T02:09:21Z","reference_number":"EMEA/COMP/663075/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309699-public-summary-positive-opinion-orphan-designation-recombinant-chimeric-monoclonal-antibody-against-cd20-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"12886","name":"COMP meeting report on the review of applications for orphan designation: June 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T18:00:00Z","last_updated_date":"2018-07-05T18:00:00Z","reference_number":"EMA/COMP/396617/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-june-2018_en.pdf"},
    {"id":"12887","name":"Propafenone: List of nationally authorised medicinal products - PSUSA/00002550/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T19:35:00Z","last_updated_date":"2016-10-19T19:35:00Z","reference_number":"EMA/645369/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/propafenone-list-nationally-authorised-medicinal-products-psusa00002550201601_en.pdf"},
    {"id":"12890","name":"Joint EMEA/EFPIA questionnaire on the new European registration system - Centralised Procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2000-03-08T00:00:00Z","last_updated_date":"2000-03-08T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joint-emeaefpia-questionnaire-new-european-registration-system-centralised-procedure_en.pdf"},
    {"id":"12891","name":"Medicines granted a Community marketing authorisation under the centralised procedure from 1 to 29 February 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-22T10:57:00Z","last_updated_date":"2012-03-22T10:57:00Z","reference_number":"EMA/198067/2012","document_url":"https://www.ema.europa.eu/en/documents/other/medicines-granted-community-marketing-authorisation-under-centralised-procedure-1-29-february-2012_en.pdf"},
    {"id":"12892","name":"Presentation - EU cooperation on HTA (Flora Giorgio, DG SANTE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-cooperation-hta-flora-giorgio-dg-sante_en.pdf"},
    {"id":"12893","name":"Download EPS - Species pictograms - Dog","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-dog_en.zip"},
    {"id":"12894","name":"Product Information Management project (\"PIM\")","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-03-26T02:00:00Z","last_updated_date":"2001-03-26T02:00:00Z","reference_number":"EMEA/T/3628/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/product-information-management-project-pim_en.pdf"},
    {"id":"12895","name":"CVMP monthly report of application procedures, guidelines and related documents: September 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-10-17T15:07:00Z","last_updated_date":"2013-10-17T15:07:00Z","reference_number":"EMA/587321/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-september-2013_en.pdf"},
    {"id":"12896","name":"Presentation - Impact of pharmacovigilance systems (Jacoline Bouvy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T16:00:00Z","last_updated_date":"2015-06-25T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-pharmacovigilance-systems-jacoline-bouvy_en.pdf"},
    {"id":"12897","name":"Concept paper on guidance on the approach on how to demonstrate whether a substance is capable of pharmacological action or not","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-11-21T01:00:00Z","last_updated_date":"2005-11-21T01:00:00Z","reference_number":"EMEA/CVMP/SWP/139646/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guidance-approach-how-demonstrate-whether-substance-capable-pharmacological-action-or-not_en.pdf"},
    {"id":"12898","name":"Presentation – Topics raised by EFPIA - Update on the implementation of EMA policy on publication of clinical data (Policy 0070) – industry associations webinar (EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-05T02:00:00Z","last_updated_date":"2017-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topics-raised-efpia-update-implementation-ema-policy-publication-clinical-data-policy-0070-industry-associations-webinar-efpia_en.pdf"},
    {"id":"12899","name":"Questions and answers on the withdrawal of the marketing authorisation application for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-02-21T11:30:00Z","last_updated_date":"2012-04-24T12:30:00Z","reference_number":"EMA/CHMP/114709/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fluad-paediatric-influenza-vaccine-surface-antigen-inactivated-adjuvanted_sv.pdf"}},
    {"id":"12900","name":"EMEA 2010 Priorities for Drug Safety Research: Safety aspects of antipsychotics in demented patients","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-08-04T02:00:00Z","last_updated_date":"2009-08-04T02:00:00Z","reference_number":"EMEA/493730/2009","document_url":"https://www.ema.europa.eu/en/documents/other/emea-2010-priorities-drug-safety-research-safety-aspects-antipsychotics-demented-patients_en.pdf"},
    {"id":"12901","name":"Presentation - Challenges to develop diagnostics for treatment of multiple drug resistant (MDR) pathogens (Herman Goossens)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-develop-diagnostics-treatment-multiple-drug-resistant-mdr-pathogens-herman-goossens_en.pdf"},
    {"id":"12903","name":"Questions and answers on the regulation of advanced therapy medicinal products","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-01-16T00:09:21Z","last_updated_date":"2009-01-16T00:09:21Z","reference_number":"EMEA/14327/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-regulation-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"12904","name":"Invitation to attend a meeting on 'progress in the area of antimicrobial resistance – veterinary medicines' organised by the European Medicines Agency and the Heads of Medicines Agencies (veterinary)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-01T02:00:00Z","last_updated_date":"2011-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/invitation-attend-meeting-progress-area-antimicrobial-resistance-veterinary-medicines-organised-european-medicines-agency-and-heads-medicines-agencies-veterinary_en.pdf"},
    {"id":"12905","name":"Report of the tenth annual workshop (2018) of the European Network of Paediatric Research at the EMA (Enpr-EMA)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-09-07T11:12:59Z","last_updated_date":"2018-09-07T11:12:59Z","reference_number":"EMA/472030/2018","document_url":"https://www.ema.europa.eu/en/documents/report/report-tenth-annual-workshop-2018-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"12906","name":"Suvaxyn Parvo/E - Article 40 Referral - Annex I, II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-16T00:59:00Z","last_updated_date":"2007-11-16T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/suvaxyn-parvoe-article-40-referral-annex-i-ii_sv.pdf"}},
    {"id":"12907","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 24-25 March 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-04-08T16:00:00Z","last_updated_date":"2014-04-08T16:00:00Z","reference_number":"EMA/HMPC/171245/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-24-25-march-2014_en.pdf"},
    {"id":"12908","name":"EU/3/15/1544: Public summary of opinion on orphan designation: 2-(2-phenylvinyl)-4-[4- methylpiperazin-1-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/508499/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151544-public-summary-opinion-orphan-designation-2-2-phenylvinyl-4-4-methylpiperazin-1-yl-6-5-methyl-2h-pyrazol-3-yl-amino-pyrimidine-l-tartrate-salt-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"12909","name":"EMEA releases guidelines on development of medicines for Alzheimer’s disease and Parkinson’s disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/460300/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-releases-guidelines-development-medicines-alzheimers-disease-and-parkinsons-disease_en.pdf"},
    {"id":"12910","name":"Presentation - Holistic approach to paediatric research: paediatric clinical trial networks (N. Ruperto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:00:00Z","last_updated_date":"2018-06-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-paediatric-clinical-trial-networks-n-ruperto_en.pdf"},
    {"id":"12911","name":"EU/3/11/913: Public summary of opinion on orphan designation: Resminostat for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/COMP/584371/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311913-public-summary-opinion-orphan-designation-resminostat-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"12913","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Tysabri (natalizumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/322273/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tysabri-natalizumab_en.pdf"},
    {"id":"12914","name":"Draft list of references for assessment of: Curcumae longae rhizoma Curcuma longa L., rhizoma (turmeric root)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-11-06T00:09:21Z","last_updated_date":"2008-11-06T00:09:21Z","reference_number":"EMEA/HMPC/456910/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-curcumae-longae-rhizoma-curcuma-longa-l-rhizoma-turmeric-root_en.pdf"},
    {"id":"12917","name":"Presentation - US Food and Drug Administration (FDA): The precision medicine initiative - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised m...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-us-food-and-drug-administration-fda-precision-medicine-initiative-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-m_en.pdf"},
    {"id":"12918","name":"Nimesulide - Article 107 procedures - Annex V","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-04-08T02:00:00Z","last_updated_date":"2010-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nimesulide-article-107-procedures-annex-v_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nimesulide-article-107-procedures-annex-v_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nimesulide-article-107-procedures-annex-v_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nimesulide-article-107-procedures-annex-v_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nimesulide-article-107-procedures-annex-v_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nimesulide-article-107-procedures-annex-v_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nimesulide-article-107-procedures-annex-v_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nimesulide-article-107-procedures-annex-v_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nimesulide-article-107-procedures-annex-v_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nimesulide-article-107-procedures-annex-v_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nimesulide-article-107-procedures-annex-v_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nimesulide-article-107-procedures-annex-v_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nimesulide-article-107-procedures-annex-v_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nimesulide-article-107-procedures-annex-v_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nimesulide-article-107-procedures-annex-v_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nimesulide-article-107-procedures-annex-v_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nimesulide-article-107-procedures-annex-v_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nimesulide-article-107-procedures-annex-v_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nimesulide-article-107-procedures-annex-v_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nimesulide-article-107-procedures-annex-v_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nimesulide-article-107-procedures-annex-v_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nimesulide-article-107-procedures-annex-v_sv.pdf"}},
    {"id":"12919","name":"CVMP summary of positive opinion for Bovela","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2014-10-10T02:00:00Z","reference_number":"EMA/CVMP/575913/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-bovela_en.pdf"},
    {"id":"12920","name":"Concept paper on the need for revision of points to consider on clinical investigation of medicinal products for the treatment of osteoarthritis (CPMP/EWP/784/97)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/141412/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-points-consider-clinical-investigation-medicinal-products-treatment-osteoarthritis-cpmpewp78497_en.pdf"},
    {"id":"12921","name":"Presentation - Root-cause analysis in context of World Health Organization international classification for patient safety (David Cousins)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-root-cause-analysis-context-world-health-organization-international-classification-patient-safety-david-cousins_en.pdf"},
    {"id":"12923","name":"Report of the East African Community (EAC) benchmarking visit to the European Medicines Agency","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-07-26T19:30:00Z","last_updated_date":"2017-07-27T19:05:00Z","reference_number":"EMA/467939/2017","document_url":"https://www.ema.europa.eu/en/documents/report/report-east-african-community-eac-benchmarking-visit-european-medicines-agency_en.pdf"},
    {"id":"12925","name":"Summary of Product Characteristics Advisory Group 2010-2015 activity report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T16:45:00Z","last_updated_date":"2016-07-07T16:45:00Z","reference_number":"EMA/748160/2015","document_url":"https://www.ema.europa.eu/en/documents/report/summary-product-characteristics-advisory-group-2010-2015-activity-report_en.pdf"},
    {"id":"12927","name":"Concept paper on the revision of the guideline for the conduct of bioequivalence studies for veterinary medicinal products (EMEA/CVMP/016/00) - Revision 2","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-12-18T01:00:00Z","last_updated_date":"2006-12-18T01:00:00Z","reference_number":"EMEA/CVMP/EWP/295306/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-emeacvmp01600-revision-2_en.pdf"},
    {"id":"12928","name":"Agenda and registration form - Individual Case Safety Report (ICSR) information day: 26 April 2016","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T13:30:00Z","last_updated_date":"2016-03-11T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-individual-case-safety-report-icsr-information-day-26-april-2016_en.pdf"},
    {"id":"12930","name":"Draft Community herbal monograph on Mentha x piperita L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2007-07-05T02:00:00Z","reference_number":"EMEA/HMPC/193909/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-mentha-x-piperita-l-folium_en.pdf"},
    {"id":"12931","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 June 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"EMA/CVMP/330061/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-june-2013_en.pdf"},
    {"id":"12936","name":"Pharmacovigilance needs and opportunities for ENCePP - Hubert G. Leufkens","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/pharmacovigilance-needs-and-opportunities-encepp-hubert-g-leufkens_en.pdf"},
    {"id":"12938","name":"Results of the sampling and testing programme for the year 2010","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-10-27T18:26:00Z","last_updated_date":"2011-10-27T18:26:00Z","reference_number":"EMA/INS/S&T/834055/2011","document_url":"https://www.ema.europa.eu/en/documents/report/results-sampling-and-testing-programme-year-2010_en.pdf"},
    {"id":"12939","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Strimvelis (autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene) for the treatment of...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-06-08T17:40:00Z","last_updated_date":"2016-06-08T17:40:00Z","reference_number":"EMA/COMP/260673/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-strimvelis-autologous-cd34-cells-transfected-retroviral-vector-containing-adenosine-deaminase-gene-treatment_en.pdf"},
    {"id":"12945","name":"European expert group proposes reduction of use in animals of last resort antibiotic colistin to manage risk of resistance","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-05-26T02:00:00Z","last_updated_date":"2016-05-26T02:00:00Z","reference_number":"EMA/355125/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-expert-group-proposes-reduction-use-animals-last-resort-antibiotic-colistin-manage-risk-resistance_en.pdf"},
    {"id":"12946","name":"Dimethyl fumarate gastro-resistant capsule 120 mg and 240 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-06-26T13:45:00Z","last_updated_date":"2018-06-26T13:45:00Z","reference_number":"EMA/CHMP/421315/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/dimethyl-fumarate-gastro-resistant-capsule-120-mg-and-240-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"12947","name":"Mandate, objectives and rules of procedure for the CHMP Biologics Working Party (BWP)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2005-01-17T01:00:00Z","last_updated_date":"2022-12-13T11:43:00Z","reference_number":"EMEA/CHMP/BWP/206296/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-chmp-biologics-working-party-bwp_en.pdf"},
    {"id":"12948","name":"Presentation - EU/EC Acquis caummunautaire: perspectives from a member state","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-euec-acquis-caummunautaire-perspectives-member-state_en.pdf"},
    {"id":"12949","name":"EU/3/12/1092: Public summary of opinion on orphan designation: Chimeric monoclonal antibody against claudin 6 for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2021-04-08T01:00:00Z","reference_number":"EMA/COMP/794326/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121092-public-summary-opinion-orphan-designation-chimeric-monoclonal-antibody-against-claudin-6-treatment-ovarian-cancer_en.pdf"},
    {"id":"12951","name":"Presentation - Industry perspective (efpia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-18T02:00:00Z","last_updated_date":"2015-06-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-efpia_en.pdf"},
    {"id":"12952","name":"Speakers’ biographies - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/speakers-biographies-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"12953","name":"CHMP summary of positive opinion for Repaglinide Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-04-27T02:00:00Z","last_updated_date":"2009-04-27T02:00:00Z","reference_number":"EMEA/CHMP/245770/2009 corr","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-repaglinide-teva_en.pdf"},
    {"id":"12954","name":"Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"CHMP/EWP/18504/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-products-specific-immunotherapy-treatment-allergic-diseases_en.pdf"},
    {"id":"12955","name":"Scientific recommendation on classification of advanced therapy medicinal products: adipose derived regenerative cells encapsulated in hyaluronic acid","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T15:30:00Z","last_updated_date":"2016-04-19T15:30:00Z","reference_number":"EMA/240965/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adipose-derived-regenerative-cells-encapsulated-hyaluronic-acid_en.pdf"},
    {"id":"12959","name":"Committee for Medicinal Products for Human Use (CHMP) - February 2004 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2004-03-04T01:00:00Z","last_updated_date":"2004-03-04T01:00:00Z","reference_number":"EMEA/CPMP/537/04","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-february-2004-plenary-meeting-monthly-report_en.pdf"},
    {"id":"12960","name":"Questions and answers on the withdrawal of the marketing authorisation\n\nfor Ixempra","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-05-20T02:00:00Z","last_updated_date":"2009-05-20T02:00:00Z","reference_number":"EMEA/196121/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ixempra_sv.pdf"}},
    {"id":"12962","name":"CHMP post-authorisation summary of positive opinion for Levemir","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/775779/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-levemir_en.pdf"},
    {"id":"12963","name":"Questions and answers on Seroquel, Seroquel XR and associated names (quetiapine)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-09-09T02:00:00Z","reference_number":"EMA/301727/2014 ","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-seroquel-seroquel-xr-and-associated-names-quetiapine_sv.pdf"}},
    {"id":"12964","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, September 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-06-14T17:00:00Z","last_updated_date":"2018-06-14T17:00:00Z","reference_number":"Course # 18515","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-berlin-september-2018_en.pdf"},
    {"id":"12965","name":"Matricaria Recutita: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/MRL/706/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/matricaria-recutita-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12967","name":"Opinion of the HMPC on a community herbal monograph on Plantago lanceolata L., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T01:00:00Z","last_updated_date":"2012-02-24T01:00:00Z","reference_number":"EMA/HMPC/888909/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-plantago-lanceolata-l-folium_en.pdf"},
    {"id":"12968","name":"Decision on amending budget No 01-2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-10-17T18:30:00Z","last_updated_date":"2013-10-17T18:30:00Z","reference_number":"EMA/MB/536520/2013","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-01-2013_en.pdf"},
    {"id":"12969","name":"Presentation - Session 5: Design concept for a confirmatory basket trial (Robert Beckman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-design-concept-confirmatory-basket-trial-robert-beckman_en.pdf"},
    {"id":"12970","name":"Concept paper on BCS-based biowaiver","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-05-24T02:00:00Z","last_updated_date":"2007-05-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/213035/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-bcs-based-biowaiver_en.pdf"},
    {"id":"12973","name":"Presentation - Activities in USA, the experience of FDA Neurology Division, Russel Katz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-activities-usa-experience-fda-neurology-division-russel-katz_en.pdf"},
    {"id":"12974","name":"Agenda - Expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-12-02T17:30:00Z","last_updated_date":"2014-12-02T17:30:00Z","reference_number":"EMA/728001/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-expert-meeting-clinical-investigation-medicines-treatment-paediatric-hepatitis-c_en.pdf"},
    {"id":"12975","name":"Presentation - CMDh project on ideas for WS of assessment of RMPs and informal WS procedure for follow up requests after a PSUSA for NAPs (K. van der Stoep)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T15:08:00Z","last_updated_date":"2018-01-04T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cmdh-project-ideas-ws-assessment-rmps-and-informal-ws-procedure-follow-requests-after-psusa-naps-k-van-der-stoep_en.pdf"},
    {"id":"12978","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 June 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/CVMP/377272/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-june-2016_en.pdf"},
    {"id":"12979","name":"Agenda for the 74th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T11:30:00Z","last_updated_date":"2011-12-20T11:30:00Z","reference_number":"EMA/MB/826035/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-74th-meeting-management-board_en.pdf"},
    {"id":"12981","name":"Session 1 - CMC - Kowid Ho","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-1-cmc-kowid-ho_en.pdf"},
    {"id":"12982","name":"Paracetamol Article-31 referral - PRAC recommends modified-release paracetamol be removed from market","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-09-01T17:00:00Z","last_updated_date":"2017-09-29T17:00:00Z","reference_number":"EMA/562720/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-prac-recommends-modified-release-paracetamol-be-removed-market_en.pdf"},
    {"id":"12983","name":"Work plan for the CHMP Respiratory Drafting Group for 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T17:15:00Z","last_updated_date":"2018-01-18T15:32:00Z","reference_number":"EMA/CHMP/383892/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-chmp-respiratory-drafting-group-2018_en.pdf"},
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    {"id":"12988","name":"Work plan for the Modelling and Simulation Working Group for 2018","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2018-02-26T13:45:00Z","last_updated_date":"2018-02-26T13:45:00Z","reference_number":"EMA/710355/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-modelling-and-simulation-working-group-2018_en.pdf"},
    {"id":"12990","name":"ICH M4E (R2) Common technical document for the registration of pharmaceuticals for human use - efficacy - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-28T19:00:00Z","last_updated_date":"2016-07-28T19:00:00Z","reference_number":"EMA/CPMP/ICH/2887/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m4e-r2-common-technical-document-registration-pharmaceuticals-human-use-efficacy-step-5_en.pdf"},
    {"id":"12992","name":"Bisphosphonates - Article 31 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bisphosphonates-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bisphosphonates-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bisphosphonates-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bisphosphonates-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bisphosphonates-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bisphosphonates-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bisphosphonates-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bisphosphonates-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bisphosphonates-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bisphosphonates-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bisphosphonates-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bisphosphonates-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bisphosphonates-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bisphosphonates-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bisphosphonates-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bisphosphonates-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bisphosphonates-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bisphosphonates-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bisphosphonates-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bisphosphonates-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bisphosphonates-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bisphosphonates-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"12993","name":"Sorbitan trioleate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-04-01T02:00:00Z","last_updated_date":"2001-04-01T02:00:00Z","reference_number":"EMEA/MRL/783/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sorbitan-trioleate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"12996","name":"Scientific recommendation on classification of advanced-therapy medicinal product: Autologous expanded CD34+ stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-07-01T12:00:00Z","last_updated_date":"2013-07-01T12:00:00Z","reference_number":"EMA/370710/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-product-autologous-expanded-cd34-stem-cells_en.pdf"},
    {"id":"12998","name":"EU/3/11/948: Public summary of positive opinion for orphan designation: Sodium phenylbutyrate for the treatment of 5q spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2012-02-13T15:00:00Z","reference_number":"EMA/COMP/928645/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311948-public-summary-positive-opinion-orphan-designation-sodium-phenylbutyrate-treatment-5q-spinal-muscular-atrophy_en.pdf"},
    {"id":"13003","name":"CHMP summary of positive opinion for Respreeza","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/76738/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-respreeza_en.pdf"},
    {"id":"13004","name":"Clinical-trial advisory groups: Membership by affiliation category","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T13:40:00Z","last_updated_date":"2013-02-21T15:11:00Z","reference_number":"EMA/33489/2013","document_url":"https://www.ema.europa.eu/en/documents/other/clinical-trial-advisory-groups-membership-affiliation-category_en.pdf"},
    {"id":"13005","name":"Questions and answers on the risk of fever with Pandemrix in young children","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-12-04T00:09:21Z","last_updated_date":"2009-12-04T00:09:21Z","reference_number":"EMEA/780391/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-risk-fever-pandemrix-young-children_en.pdf"},
    {"id":"13006","name":"Presentation - Partnering to optimize and accelerate pediatric clinical trials (C. Hovinga)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-partnering-optimize-and-accelerate-pediatric-clinical-trials-c-hovinga_en.pdf"},
    {"id":"13008","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T15:00:00Z","last_updated_date":"2013-06-10T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-iii_no.pdf"}},
    {"id":"13009","name":"Presentation - Procedural update: post-authorisation procedures (Melanie Leivers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedural-update-post-authorisation-procedures-melanie-leivers_en.pdf"},
    {"id":"13010","name":"Template for a public statement when no European Union herbal monograph is established","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2011-07-20T02:00:00Z","last_updated_date":"2020-07-29T15:32:00Z","reference_number":"EMA/HMPC/75972/2010 Rev. 1 Corr.  1","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-public-statement-when-no-european-union-herbal-monograph-established_en.doc"},
    {"id":"13015","name":"EU/3/15/1521: Public summary of opinion on orphan designation: Artesunate for the treatment of malaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/422819/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151521-public-summary-opinion-orphan-designation-artesunate-treatment-malaria_en.pdf"},
    {"id":"13016","name":"Advisory Committee on Procurement and Contract (ACPC)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-10T14:00:00Z","last_updated_date":"2012-10-10T14:00:00Z","reference_number":"EMA/609678/201212","document_url":"https://www.ema.europa.eu/en/documents/other/advisory-committee-procurement-and-contract-acpc_en.pdf"},
    {"id":"13022","name":"Organisational matters coming out of the CHMP meeting of 16-19 April 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-04-23T02:00:00Z","last_updated_date":"2012-04-23T02:00:00Z","reference_number":"EMA/CHMP/213036/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-coming-out-chmp-meeting-16-19-april-2012_en.pdf"},
    {"id":"13024","name":"'Neuroprotection' in Neurodegenerative disorders. Towards a change in the paradigm?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-11T00:09:21Z","last_updated_date":"2008-02-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/neuroprotection-neurodegenerative-disorders-towards-change-paradigm_en.pdf"},
    {"id":"13025","name":"Sample profile specification and a request form for software applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sample-profile-specification-and-request-form-software-applications_en.pdf"},
    {"id":"13026","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 06-08 September 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-09-09T02:00:00Z","last_updated_date":"2016-09-09T02:00:00Z","reference_number":"EMA/CVMP/542033/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-06-08-september-2016_en.pdf"},
    {"id":"13028","name":"Outcome of the European Medicines Agency survey on advanced-therapy-medicinal-product certification for small and medium-sized enterprises - Commission Regulations (EC) No. 1349/2007 and 668/2009","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-07T11:26:00Z","last_updated_date":"2013-02-07T11:26:00Z","reference_number":"EMA/66222/2012","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-european-medicines-agency-survey-advanced-therapy-medicinal-product-certification-small-and-medium-sized-enterprises-commission-regulations-ec-no-13492007-and-6682009_en.pdf"},
    {"id":"13029","name":"Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance (Rev. 1)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-06-26T15:50:00Z","last_updated_date":"2018-06-26T15:50:00Z","reference_number":"EMA/CHMP/156358/2016/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paliperidone-prolonged-release-tablet-15-mg-3-mg-6-mg-9-mg-and-12-mg-product-specific-bioequivalence-guidance-rev-1_en.pdf"},
    {"id":"13030","name":"PDCO meeting highlights 11-13 November 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-11-20T00:09:21Z","last_updated_date":"2009-11-25T00:00:00Z","reference_number":"EMEA/PDCO/716413/2009 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-11-13-november-2009_en.pdf"},
    {"id":"13031","name":"Amendments to Management Board implementing rules on the Agency’s fees in relation to extensions of marketing authorisation, Type II variations, annual fees, variations to plasma master files and vaccine antigen master f...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/MB/818152/2009","document_url":"https://www.ema.europa.eu/en/documents/other/amendments-management-board-implementing-rules-agencys-fees-relation-extensions-marketing-authorisation-type-ii-variations-annual-fees-variations-plasma-master-files-and-vaccine-antigen-master-f_en.pdf"},
    {"id":"13033","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-03-24T14:55:00Z","last_updated_date":"2014-03-24T14:55:00Z","reference_number":"EMA/CAT/161687/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-march-2014-meeting_en.pdf"},
    {"id":"13034","name":"Presentation - Scientific advice and its impact on marketing authorisation reviews (Jan Rengstrom)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advice-and-its-impact-marketing-authorisation-reviews-jan-rengstrom_en.pdf"},
    {"id":"13035","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Autologous CD34+ haematopoietic stem cells (HSCs) transduced with lentiviral vector LentiGlobin encoding the human βA-T87Q-globin gene","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-09-25T15:21:00Z","last_updated_date":"2012-09-25T15:21:00Z","reference_number":"EMA/505476/2012","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cd34-haematopoietic-stem-cells-hscs-transduced-lentiviral-vector-lentiglobin-encoding-human-i2a-t87q-globin-gene_en.pdf"},
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opa.eu/sk/documents/referral/gentamicin-article-35-opinion-following-article-35-referral-veterinary-medicinal-products-containing-gentamicin-presented-solutions-injection-be-administered-horses-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gentamicin-article-35-opinion-following-article-35-referral-veterinary-medicinal-products-containing-gentamicin-presented-solutions-injection-be-administered-horses-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gentamicin-article-35-opinion-following-article-35-referral-veterinary-medicinal-products-containing-gentamicin-presented-solutions-injection-be-administered-horses-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gentamicin-article-35-opinion-following-article-35-referral-veterinary-medicinal-products-containing-gentamicin-presented-solutions-injection-be-administered-horses-background-information_sv.pdf"}},
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    {"id":"13140","name":"Final reflection paper on the risks associated with Furocoumarins contained in preparations of Angelica archangelica L.","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/317913/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/final-reflection-paper-risks-associated-furocoumarins-contained-preparations-angelica-archangelica-l_en.pdf"},
    {"id":"13146","name":"CHMP post-authorisation summary of positive opinion for Trevicta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/237035/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trevicta_en.pdf"},
    {"id":"13148","name":"EU/3/17/1894: Public summary of opinion on orphan designation: Recombinant human antibody directed against misfolded human superoxide dismutase 1 for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-14T16:54:00Z","last_updated_date":"2017-08-14T16:54:00Z","reference_number":"EMA/395085/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171894-public-summary-opinion-orphan-designation-recombinant-human-antibody-directed-against-misfolded-human-superoxide-dismutase-1-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"13152","name":"Opinion of the CVMP on the establishment of maximum residue limits: Copper carbonate","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T12:10:00Z","last_updated_date":"2016-05-27T12:10:00Z","reference_number":"EMA/CVMP/758984/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-copper-carbonate_en.pdf"},
    {"id":"13154","name":"Bromelain (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2018-01-31T18:00:00Z","last_updated_date":"2018-01-31T18:00:00Z","reference_number":"EMA/CVMP/208391/2017","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bromelain-porcine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"13155","name":"Agenda - Patients/Consumers Working Party (PCWP) and Healthcare Professionals Working Group (HCP WG) joint meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2012-02-27T01:00:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"EMA/995452/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patientsconsumers-working-party-pcwp-and-healthcare-professionals-working-group-hcp-wg-joint-meeting_en.pdf"},
    {"id":"13157","name":"Methadone Article-107i procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-04T02:00:00Z","last_updated_date":"2014-08-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methadone-article-107i-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methadone-article-107i-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methadone-article-107i-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methadone-article-107i-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methadone-article-107i-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methadone-article-107i-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methadone-article-107i-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methadone-article-107i-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methadone-article-107i-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methadone-article-107i-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methadone-article-107i-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methadone-article-107i-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methadone-article-107i-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methadone-article-107i-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methadone-article-107i-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methadone-article-107i-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methadone-article-107i-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methadone-article-107i-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methadone-article-107i-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methadone-article-107i-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methadone-article-107i-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methadone-article-107i-procedure-annex-iv_sv.pdf"}},
    {"id":"13158","name":"23rd meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-05-02T02:09:21Z","last_updated_date":"2002-05-02T02:09:21Z","reference_number":"EMEA/COMP/824/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/23rd-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"13159","name":"European Medicines Agency budget for 2018","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-01-18T10:00:00Z","last_updated_date":"2018-01-18T10:00:00Z","reference_number":"EMA/MB/799068/2017","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2018_en.pdf"},
    {"id":"13160","name":"Ciclesonide: List of nationally authorised medicinal products - PSUSA/00000742/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-20T02:00:00Z","last_updated_date":"2016-10-18T15:41:13Z","reference_number":"EMA/281184/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciclesonide-list-nationally-authorised-medicinal-products-psusa00000742201508_en.pdf"},
    {"id":"13161","name":"Final list of references supporting the assessment of Primula veris L. and / or Primula elatior (L.) Hill, radix","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2013-03-04T01:00:00Z","last_updated_date":"2013-03-04T01:00:00Z","reference_number":"EMA/HMPC/113665/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-primula-veris-l-and-or-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"13164","name":"Superseded community herbal monograph on Centaurium erythraea Rafn, herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T00:09:21Z","last_updated_date":"2016-01-28T00:09:21Z","reference_number":"EMEA/HMPC/105536/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-centaurium-erythraea-rafn-herba_en.pdf"},
    {"id":"13166","name":"Scientific recommendation on classification of advanced therapy medicinal products: adeno-associated virus vector serotype rh10 encoding human factor IX","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-22T12:00:00Z","last_updated_date":"2016-03-22T12:00:00Z","reference_number":"EMA/205254/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adeno-associated-virus-vector-serotype-rh10-encoding-human-factor-ix_en.pdf"},
    {"id":"13169","name":"European Medicines Agency statement following seizure of Avandamet tablets by US Food and Drug Administration","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-03-04T00:09:21Z","last_updated_date":"2005-03-04T00:09:21Z","reference_number":"EMEA/84957/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-statement-following-seizure-avandamet-tablets-us-food-and-drug-administration_en.pdf"},
    {"id":"13171","name":"Guideline on good pharmacovigilance practices: Module V – Risk management systems with tracked changes (Rev. 1)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T11:30:00Z","last_updated_date":"2014-04-25T11:30:00Z","reference_number":"EMA/838713/2011 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-tracked-changes-rev-1_en.pdf"},
    {"id":"13172","name":"Promestriene (cream and vaginal capsules): List of nationally authorised medicinal products - PSUSA/00009271/201603 IIII","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-12-07T12:18:14Z","reference_number":"EMA/751259/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/promestriene-cream-and-vaginal-capsules-list-nationally-authorised-medicinal-products-psusa00009271201603-iiii_en.pdf"},
    {"id":"13173","name":"EU/3/12/957: Public summary of opinion on orphan designation: Autologous haematopoietic cells genetically modified with a lentiviral vector containing the human gp91(phox) gene for the treatment of X-linked chronic granu...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2012-03-01T01:00:00Z","reference_number":"EMA/COMP/969323/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312957-public-summary-opinion-orphan-designation-autologous-haematopoietic-cells-genetically-modified-lentiviral-vector-containing-human-gp91phox-gene-treatment-x-linked-chronic-granu_en.pdf"},
    {"id":"13175","name":"Local tolerance of intramammary preparations in cows","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1992-11-01T01:00:00Z","last_updated_date":"1992-11-01T01:00:00Z","reference_number":"7AE21a Volume 7 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/local-tolerance-intramammary-preparations-cows_en.pdf"},
    {"id":"13176","name":"Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-01-03T18:18:00Z","last_updated_date":"2017-01-03T18:18:00Z","reference_number":"EMA/CVMP/EWP/117899/2004–Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-efficacy-and-target-animal-safety-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mumslimited-market-revision-1_en.pdf"},
    {"id":"13177","name":"CHMP summary of positive opinion for Paliperidone Janssen","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/CHMP/605917/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-paliperidone-janssen_en.pdf"},
    {"id":"13178","name":"GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/324341/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/gvk-biosciences-european-medicines-agency-confirms-recommendation-suspend-medicines-over-flawed-studies_en.pdf"},
    {"id":"13179","name":"Agenda for the 76th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2012-06-14T16:30:00Z","last_updated_date":"2012-06-14T16:30:00Z","reference_number":"EMA/MB/92770/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-76th-meeting-management-board_en.pdf"},
    {"id":"13181","name":"EU/3/01/052: Public summary of positive opinion for orphan designation of seocalcitol for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-11-08T00:00:00Z","last_updated_date":"2004-11-08T00:00:00Z","reference_number":"EMEA/COMP/1291/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301052-public-summary-positive-opinion-orphan-designation-seocalcitol-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"13184","name":"CHMP post-authorisation summary of positive opinion for NovoThirteen","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-01-24T13:00:00Z","last_updated_date":"2014-01-24T13:00:00Z","reference_number":"EMA/CHMP/21116/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-novothirteen_en.pdf"},
    {"id":"13185","name":"Tygacil renewal highlighted PI","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-02-18T14:06:01Z","last_updated_date":"2011-02-18T14:06:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/tygacil-renewal-highlighted-pi_en.pdf"},
    {"id":"13187","name":"More information on a joint meeting by TOPRA and the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-10-24T02:09:21Z","last_updated_date":"2008-10-24T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/more-information-joint-meeting-topra-and-european-medicines-agency_en.pdf"},
    {"id":"13189","name":"Short-acting beta-agonists Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-07T01:00:00Z","last_updated_date":"2013-11-07T01:00:00Z","reference_number":"EMA/664276/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/short-acting-beta-agonists-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"13190","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Blincyto (blinatumomab) for the treatment of acute lymphoblastic leukaemia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-12-08T11:00:00Z","last_updated_date":"2015-12-08T11:00:00Z","reference_number":"EMA/655660/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-blincyto-blinatumomab-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"13192","name":"Agenda - Third EMA-EGA Info Day - Generic and biosimilar medicines in the centralised procedure","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-11-09T01:00:00Z","last_updated_date":"2010-11-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-third-ema-ega-info-day-generic-and-biosimilar-medicines-centralised-procedure_en.pdf"},
    {"id":"13193","name":"30th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-12-13T00:09:21Z","last_updated_date":"2002-12-13T00:09:21Z","reference_number":"EMEA/COMP/2997/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/30th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"13194","name":"Tea tree oil: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T12:16:00Z","last_updated_date":"2017-03-09T12:16:00Z","reference_number":"EMA/814441/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/tea-tree-oil-summary-public_en.pdf"},
    {"id":"13196","name":"European Antibiotic Awareness Day 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-11-17T01:00:00Z","last_updated_date":"2015-11-18T11:04:00Z","reference_number":"EMA/757302/2015 Corr.","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-antibiotic-awareness-day-2015_en.pdf"},
    {"id":"13198","name":"Rules for the implementation of Regulation (EC) No 1049/2001 on access to EMEA documents","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2007-01-11T00:09:21Z","last_updated_date":"2007-01-11T00:09:21Z","reference_number":"EMEA/MB/203359/2006 Rev 1 Adopted","document_url":"https://www.ema.europa.eu/en/documents/other/rules-implementation-regulation-ec-no-10492001-access-emea-documents_en.pdf"},
    {"id":"13199","name":"Joint Committee on Proprietary Medicinal Products / CVMP note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products: Explanatory note for ...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-02-28T01:00:00Z","last_updated_date":"2001-02-28T01:00:00Z","reference_number":"EMEA/CPMP/BWP/498/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/joint-committee-proprietary-medicinal-products-cvmp-note-guidance-minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-and-veterinary-medicinal-products-explanatory-note_en.pdf"},
    {"id":"13203","name":"CHMP post-authorisation summary of positive opinion for Kinzalmono on 22 October 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/CHMP/681835/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kinzalmono-22-october-2009_en.pdf"},
    {"id":"13204","name":"European Medicines Agency Management Board strengthens conflicts of interest policies and transparency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-26T13:10:00Z","last_updated_date":"2012-03-26T13:10:00Z","reference_number":"EMA/201172/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-management-board-strengthens-conflicts-interest-policies-and-transparency_en.pdf"},
    {"id":"13205","name":"Efficacy Topics - Lois Hinman, Spiros Vamvakas, Salange Rohou","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/efficacy-topics-lois-hinman-spiros-vamvakas-salange-rohou_en.pdf"},
    {"id":"13207","name":"General Court confirms EMA approach to transparency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-06T10:28:00Z","last_updated_date":"2018-02-06T10:28:00Z","reference_number":"EMA/73690/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/general-court-confirms-ema-approach-transparency_en.pdf"},
    {"id":"13211","name":"Draft guideline on xenogeneic cell-based medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-02-27T01:00:00Z","last_updated_date":"2009-02-27T01:00:00Z","reference_number":"EMEA/CHMP/CPWP/83508/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-xenogeneic-cell-based-medicinal-products_en.pdf"},
    {"id":"13213","name":"Presentation - New EudraVigilance system – Progress update (S. Brosch, F. Domergue)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-eudravigilance-system-progress-update-s-brosch-f-domergue_en.pdf"},
    {"id":"13215","name":"Addendum to the Guideline on antiarrhythmics on atrial fibrillation and atrial flutter","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-09-20T02:00:00Z","last_updated_date":"2010-09-20T02:00:00Z","reference_number":"EMA/CHMP/EWP/213056/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/addendum-guideline-antiarrhythmics-atrial-fibrillation-and-atrial-flutter_en.pdf"},
    {"id":"13218","name":"CVMP summary of positive opinion for Osurnia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/CVMP/290192/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-osurnia_en.pdf"},
    {"id":"13219","name":"Draft assessment report on Silybum marianum (L.) Gaertn., fructus","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-07-23T12:50:00Z","last_updated_date":"2015-07-23T12:50:00Z","reference_number":"EMA/HMPC/294188/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-silybum-marianum-l-gaertn-fructus_en.pdf"},
    {"id":"13220","name":"CHMP post-authorisation summary of positive opinion for Prezista on 23 October 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:00:00Z","last_updated_date":"2008-10-23T02:00:00Z","reference_number":"EMEA/CHMP/552332/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prezista-23-october-2008_en.pdf"},
    {"id":"13221","name":"Draft list of references supporting the assessment of Cichorium intybus L., radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2012-06-15T13:00:00Z","last_updated_date":"2012-06-15T13:00:00Z","reference_number":"EMA/HMPC/113046/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-cichorium-intybus-l-radix_en.pdf"},
    {"id":"13225","name":"2014 activity report of the modelling and simulation working group","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-04-17T12:40:00Z","last_updated_date":"2015-04-17T12:40:00Z","reference_number":"EMA/91752/2015","document_url":"https://www.ema.europa.eu/en/documents/report/2014-activity-report-modelling-and-simulation-working-group_en.pdf"},
    {"id":"13226","name":"Questions and answers on withdrawal of marketing application for Surfaxin","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-06-29T02:00:00Z","last_updated_date":"2006-06-29T02:00:00Z","reference_number":"EMEA/CHMP/220307/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-surfaxin_sv.pdf"}},
    {"id":"13227","name":"European Medicines Agency recommends update of product information of Tysabri and risk of progressive multifocal leukoencephalopathy (PML)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-25T02:00:00Z","last_updated_date":"2008-09-25T02:00:00Z","reference_number":"EMEA/CHMP/496612/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-update-product-information-tysabri-and-risk-progressive-multifocal-leukoencephalopathy-pml_en.pdf"},
    {"id":"13232","name":"Reflection paper on the development of the European medicines web portal","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T17:30:00Z","last_updated_date":"2016-10-11T17:30:00Z","reference_number":"EMA/585981/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-development-european-medicines-web-portal_en.pdf"},
    {"id":"13233","name":"Report from the 2nd workshop for the EMEA /CHMP working group with patients organisations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-03-17T01:00:00Z","last_updated_date":"2005-03-17T01:00:00Z","reference_number":"EMEA/17857/2005 Final","document_url":"https://www.ema.europa.eu/en/documents/report/report-2nd-workshop-emea-chmp-working-group-patients-organisations_en.pdf"},
    {"id":"13234","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - March 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-04-03T16:00:00Z","last_updated_date":"2012-04-03T16:00:00Z","reference_number":"EMA/CHMP/PhVWP/183322/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-march-2012_en.pdf"},
    {"id":"13236","name":"Recommendation to marketing-authorisation holders for veterinary vaccines, highlighting the need to update marketing authorisations to remove the target animal batch safety test (TABST) following removal of the requireme...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-06-17T13:10:00Z","last_updated_date":"2013-06-17T13:10:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/746429/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-marketing-authorisation-holders-veterinary-vaccines-highlighting-need-update-marketing-authorisations-remove-target-animal-batch-safety-test-tabst-following-removal-requireme_en.pdf"},
    {"id":"13237","name":"Development of a Consolidated Pediatric Rheumatology Observational Registry, Dr Jeffrey Siegel","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/development-consolidated-pediatric-rheumatology-observational-registry-dr-jeffrey-siegel_en.pdf"},
    {"id":"13239","name":"Agenda - First European Medicines Agency and the European Generic and Biosimilar Medicines Association (EGA) annual bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"EMA/866175/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-european-medicines-agency-and-european-generic-and-biosimilar-medicines-association-ega-annual-bilateral-meeting_en.pdf"},
    {"id":"13241","name":"Agenda: First anniversary of PRIME: experience so far","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-03-22T15:00:00Z","last_updated_date":"2017-05-12T18:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-anniversary-prime-experience-so-far_en.pdf"},
    {"id":"13242","name":"European Medicines Agency and EUnetHTA review progress of their cooperation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T02:00:00Z","last_updated_date":"2013-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-eunethta-review-progress-their-cooperation_en.pdf"},
    {"id":"13243","name":"EU/3/04/260: Public summary of positive opinion for orphan designation of recombinant human α-mannosidase for the treatment of α-mannosidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMEA/COMP/194136/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304260-public-summary-positive-opinion-orphan-designation-recombinant-human-i-mannosidase-treatment-i-mannosidosis_en.pdf"},
    {"id":"13247","name":"CHMP post-authorisation summary of positive opinion for Copalia HCT","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/CHMP/397231/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-copalia-hct_en.pdf"},
    {"id":"13248","name":"Template - Standard statements for change of applicant due to Brexit","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T16:00:00Z","last_updated_date":"2018-06-19T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-standard-statements-change-applicant-due-brexit_en.doc"},
    {"id":"13250","name":"EU/3/10/812: Public summary of opinion on orphan designation: Recombinant fusion protein consisting of the extracellular portion of human activin receptor IIB linked to the human IgG1 Fc domain for the treatment of Duche...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMA/COMP/602192/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310812-public-summary-opinion-orphan-designation-recombinant-fusion-protein-consisting-extracellular-portion-human-activin-receptor-iib-linked-human-igg1-fc-domain-treatment-duche_en.pdf"},
    {"id":"13252","name":"Declaration of interests - Anne Junker","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-anne-junker_en.pdf"},
    {"id":"13255","name":"European Medicines Agency to grant fee waivers to applications for bluetongue vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-04-01T02:00:00Z","last_updated_date":"2008-04-01T02:00:00Z","reference_number":"EMEA/111979/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-grant-fee-waivers-applications-bluetongue-vaccines_en.pdf"},
    {"id":"13257","name":"Presentation - Day 2: Meibomian gland dysfunction","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-meibomian-gland-dysfunction_en.pdf"},
    {"id":"13258","name":"Cymevene Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T13:00:00Z","last_updated_date":"2016-06-21T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cymevene-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cymevene-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cymevene-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cymevene-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cymevene-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cymevene-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cymevene-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cymevene-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cymevene-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cymevene-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cymevene-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cymevene-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cymevene-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cymevene-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cymevene-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cymevene-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cymevene-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cymevene-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cymevene-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cymevene-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cymevene-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cymevene-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cymevene-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/cymevene-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/cymevene-article-30-referral-annex-iii_no.pdf"}},
    {"id":"13259","name":"Final assessment report on Pimpinella anisum L., fructus and Pimpinella anisum L., aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-06-18T02:00:00Z","last_updated_date":"2014-06-18T02:00:00Z","reference_number":"EMEA/HMPC/321181/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-pimpinella-anisum-l-fructus-and-pimpinella-anisum-l-aetheroleum_en.pdf"},
    {"id":"13260","name":"Christine Fletcher (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/christine-fletcher-cv_en.pdf"},
    {"id":"13263","name":"Draft assessment report on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix  - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-08-19T02:00:00Z","last_updated_date":"2011-08-19T02:00:00Z","reference_number":"EMA/HMPC/571122/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-glycyrrhiza-glabra-l-andor-glycyrrhiza-inflata-bat-andor-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"13264","name":"EU/3/15/1551: Public summary of opinion on orphan designation: Recombinant human IgG1 kappa light chain monoclonal antibody targeting plasma kallikrein for the treatment of hereditary angioedema","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-16T01:00:00Z","last_updated_date":"2015-11-16T01:00:00Z","reference_number":"EMA/COMP/603277/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151551-public-summary-opinion-orphan-designation-recombinant-human-igg1-kappa-light-chain-monoclonal-antibody-targeting-plasma-kallikrein-treatment-hereditary-angioedema_en.pdf"},
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    {"id":"13310","name":"Initial clinical trial protocol design considerations, Dr Walter Janssens","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/initial-clinical-trial-protocol-design-considerations-dr-walter-janssens_en.pdf"},
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    {"id":"13315","name":"Mylan S.A.S. withdraws its marketing authorisation application for Docetaxel Mylan (docetaxel)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-15T01:00:00Z","last_updated_date":"2010-03-15T01:00:00Z","reference_number":"EMA/164498/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/mylan-sas-withdraws-its-marketing-authorisation-application-docetaxel-mylan-docetaxel_en.pdf"},
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    {"id":"13327","name":"EU/3/07/476: Public summary of positive opinion for orphan designation of 5'-O-(trans-9\"-octadecenoyl)-1-àŸ-D-arabinofuranosyl cytosine for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2014-05-08T02:00:00Z","reference_number":"EMEA/COMP/127723/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307476-public-summary-positive-opinion-orphan-designation-5-o-trans-9-octadecenoyl-1-ay-d-arabinofuranosyl-cytosine-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"13329","name":"Recommendations on eligibility to PRIME scheme  - Adopted at the CHMP meeting of 11-14 December 2017","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2017-12-20T15:00:00Z","last_updated_date":"2017-12-20T15:00:00Z","reference_number":"EMA/668784/2016","document_url":"https://www.ema.europa.eu/en/documents/report/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-11-14-december-2017_en.pdf"},
    {"id":"13331","name":"Presentation - How does United European Gastroenterology communicate and disseminate information released by the European Medicines Agency? (Michel Delvaux)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-does-united-european-gastroenterology-communicate-and-disseminate-information-released-european-medicines-agency-michel-delvaux_en.pdf"},
    {"id":"13333","name":"Q8 (R1) Annex to Q8, Pharmaceutical development - Robert Baum","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/q8-r1-annex-q8-pharmaceutical-development-robert-baum_en.pdf"},
    {"id":"13334","name":"EU/3/14/1331: Public summary of opinion on orphan designation: Recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB linked to the human IgG1 Fc domain for the...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMA/COMP/435101/2014 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141331-public-summary-opinion-orphan-designation-recombinant-fusion-protein-consisting-modified-form-extracellular-domain-human-activin-receptor-iib-linked-human-igg1-fc-domain_en.pdf"},
    {"id":"13336","name":"WHO - Pharmaceutical Policies - Milan Smid","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/who-pharmaceutical-policies-milan-smid_en.pdf"},
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    {"id":"13342","name":"European Medicines Agency concludes review of modified-release oral opioids of the WHO level III scale for the management of pain","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2010-07-23T02:00:00Z","reference_number":"EMA/463702/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-review-modified-release-oral-opioids-who-level-iii-scale-management-pain_en.pdf"},
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    {"id":"13359","name":"Agenda - “Progress in the area of Antimicrobial Resistance – Veterinary Medicines” organised by the EMA and the HMA (veterinary)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-progress-area-antimicrobial-resistance-veterinary-medicines-organised-ema-and-hma-veterinary_en.pdf"},
    {"id":"13361","name":"Minutes of Enpr-EMA Coordinating Group meeting with Chairs of the working groups","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-03-06T01:00:00Z","last_updated_date":"2017-03-06T01:00:00Z","reference_number":"EMA/45320/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-enpr-ema-coordinating-group-meeting-chairs-working-groups_en.pdf"},
    {"id":"13363","name":"Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 4 March 2015","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-06-19T18:58:00Z","last_updated_date":"2015-06-19T18:58:00Z","reference_number":"EMA/14656/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-4-march-2015_en.pdf"},
    {"id":"13364","name":"EU/3/14/1357: Public summary of opinion on orphan designation: Imatinib for the treatment of acute respiratory distress syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"EMA/COMP/660447/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141357-public-summary-opinion-orphan-designation-imatinib-treatment-acute-respiratory-distress-syndrome_en.pdf"},
    {"id":"13366","name":"CHMP public assessment report on the shortage of Fabrazyme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2010-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-public-assessment-report-shortage-fabrazyme_en.pdf"},
    {"id":"13367","name":"Fluvoxamine: List of nationally authorised medicinal products - PSUSA/00001458/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T12:30:00Z","last_updated_date":"2018-04-13T12:30:00Z","reference_number":"EMA/231137/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluvoxamine-list-nationally-authorised-medicinal-products-psusa00001458201707_en.pdf"},
    {"id":"13369","name":"Presentation - Guideline on Similar biological medicinal products\n\ncontaining biotechnology-derived proteins as active\n\nsubstance: Non-clinical and clinical issues (Pekka Kurki)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-pekka-kurki_en.pdf"},
    {"id":"13370","name":"CHMP post-authorisation summary of positive opinion for Revestive","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/178344/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revestive_en.pdf-0"},
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    {"id":"13374","name":"EU/3/01/039: Public summary of positive opinion for orphan designation of ecteinascidin 743 for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T01:00:00Z","last_updated_date":"2007-12-04T01:00:00Z","reference_number":"EMEA/COMP/1292/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301039-public-summary-positive-opinion-orphan-designation-ecteinascidin-743-treatment-soft-tissue-sarcoma_en.pdf"},
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    {"id":"13378","name":"News bulletin for small and medium-sized enterprises - Issue 6","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2008-12-01T01:00:00Z","last_updated_date":"2008-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-6_en.pdf"},
    {"id":"13379","name":"EU/3/18/1997: Public summary of opinion on orphan designation: Miransertib for the treatment of Proteus syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-15T02:00:00Z","last_updated_date":"2018-05-15T02:00:00Z","reference_number":"EMA/119696/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181997-public-summary-opinion-orphan-designation-miransertib-treatment-proteus-syndrome_en.pdf"},
    {"id":"13380","name":"Presentation - Setting cpecifications - Statistical considerations, Enda Moran, Pfizer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T02:00:00Z","last_updated_date":"2011-10-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-setting-cpecifications-statistical-considerations-enda-moran-pfizer_en.pdf"},
    {"id":"13381","name":"2006 EMEA/IFAH-Europe Info Day: Stimulating innovation and managing risk in market access to the veterinary sector","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-11-16T12:09:21Z","last_updated_date":"2006-11-16T12:09:21Z","reference_number":"EMEA/456812/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/2006-emeaifah-europe-info-day-stimulating-innovation-and-managing-risk-market-access-veterinary-sector_en.pdf"},
    {"id":"13382","name":"EU/3/14/1252: Public summary of opinion on orphan designation: Cysteamine bitartrate for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-06T02:00:00Z","last_updated_date":"2014-05-06T02:00:00Z","reference_number":"EMA/COMP/93499/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141252-public-summary-opinion-orphan-designation-cysteamine-bitartrate-treatment-pancreatic-cancer_en.pdf"},
    {"id":"13383","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 December 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"EMA/CVMP/790580/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-december-2015_en.pdf"},
    {"id":"13384","name":"Recognition criteria for self assessment - Enpr-EMA: FIMP - MCRN (Italian Paediatric Federation- Medicines for Children Research Network)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817617/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-fimp-mcrn-italian-paediatric-federation-medicines-children-research-network_en.pdf"},
    {"id":"13385","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 19 to 21 March 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-03-21T01:00:00Z","last_updated_date":"2002-03-21T01:00:00Z","reference_number":"EMEA/D/7412/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-19-21-march-2002_en.pdf"},
    {"id":"13386","name":"Metformin Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T01:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metformin-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metformin-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metformin-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metformin-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metformin-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metformin-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metformin-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metformin-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metformin-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metformin-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metformin-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metformin-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metformin-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metformin-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metformin-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metformin-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metformin-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metformin-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metformin-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metformin-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metformin-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metformin-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metformin-article-31-referral-annex-ii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/metformin-article-31-referral-annex-ii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/metformin-article-31-referral-annex-ii_no.pdf"}},
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    {"id":"13390","name":"Superseded list of references supporting the assessment report on: Lupuli flos Humulus lupulus L., flos (hop strobiles) - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-07-11T02:00:00Z","last_updated_date":"2014-08-07T02:00:00Z","reference_number":"EMEA/HMPC/262640/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-lupuli-flos-humulus-lupulus-l-flos-hop-strobiles-first-version_en.pdf"},
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    {"id":"13393","name":"Bromocriptine Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-02T02:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bromocriptine-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bromocriptine-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bromocriptine-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bromocriptine-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bromocriptine-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bromocriptine-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bromocriptine-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bromocriptine-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/bromocriptine-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bromocriptine-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bromocriptine-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bromocriptine-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bromocriptine-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bromocriptine-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bromocriptine-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bromocriptine-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bromocriptine-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bromocriptine-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bromocriptine-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bromocriptine-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bromocriptine-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bromocriptine-article-31-referral-annex-ii_sv.pdf"}},
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    {"id":"13399","name":"Superseded Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-04-19T02:00:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/573460/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-revision-1_en.pdf"},
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    {"id":"13410","name":"European Medicines Agency update on review of non-selective NSAIDs","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-09-26T02:00:00Z","last_updated_date":"2006-09-26T02:00:00Z","reference_number":"EMEA/378695/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-update-review-non-selective-nsaids_en.pdf"},
    {"id":"13412","name":"Orphan-medicinal-product designation","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2015-05-18T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/orphan-medicinal-product-designation_en.pdf"},
    {"id":"13413","name":"Presentation - Belgian Centre of Pharmacotherapeutical Information: The EMA and Primary Health Care - An ambiguous relation? (Thierry Christiaens)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T02:00:00Z","last_updated_date":"2016-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-belgian-centre-pharmacotherapeutical-information-ema-and-primary-health-care-ambiguous-relation-thierry-christiaens_en.pdf"},
    {"id":"13414","name":"CHMP summary of positive opinion for Irbesartan Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/456015/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-irbesartan-teva_en.pdf"},
    {"id":"13415","name":"EU/3/16/1823: Public summary of opinion on orphan designation: Pioglitazone hydrochloride for the treatment of sudden sensorineural hearing loss","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/5816/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161823-public-summary-opinion-orphan-designation-pioglitazone-hydrochloride-treatment-sudden-sensorineural-hearing-loss_en.pdf"},
    {"id":"13416","name":"Draft concept paper on the development of a guideline on the non-clinical\n\nStudies prior to clinical use of gene therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"EMEA/CHMP/GTWP/203821/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-guideline-non-clinical-studies-prior-clinical-use-gene-therapy-medicinal-products_en.pdf"},
    {"id":"13420","name":"Immunogenicity Assessment of Therapeutic Proteins: Strategy of RMP - Adrian Thomas","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-09-04T02:09:21Z","last_updated_date":"2007-09-04T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/immunogenicity-assessment-therapeutic-proteins-strategy-rmp-adrian-thomas_en.pdf"},
    {"id":"13421","name":"Template for overview of comments received on on draft European Union herbal monograph or European Union list entry","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2014-11-17T15:30:00Z","reference_number":"EMEA/HMPC/411398/2006 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-overview-comments-received-draft-european-union-herbal-monograph-or-european-union-list-entry_en.doc"},
    {"id":"13425","name":"Echinacea purpurea: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-08-10T02:00:00Z","last_updated_date":"1998-08-10T02:00:00Z","reference_number":"EMEA/MRL/357/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/echinacea-purpurea-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13426","name":"CHMP summary of positive opinion for Nerlynx","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T14:00:00Z","last_updated_date":"2018-06-29T14:00:00Z","reference_number":"EMA/CHMP/433871/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nerlynx_en.pdf"},
    {"id":"13427","name":"Questions and answers on the withdrawal of the marketing authorisation application for Factive (gemifloxacin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"EMEA/409402/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-factive-gemifloxacin_sv.pdf"}},
    {"id":"13431","name":"EU/3/08/554: Public summary of positive opinion for orphan designation of beraprost sodium (modified release tablet) for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2020-02-11T02:00:00Z","reference_number":"EMA/COMP/369082/2008 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308554-public-summary-positive-opinion-orphan-designation-beraprost-sodium-modified-release-tablet-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"13435","name":"Minutes of the 89th meeting of the Management Board","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2015-11-16T10:30:00Z","last_updated_date":"2015-11-16T10:30:00Z","reference_number":"EMA/MB/313663/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-89th-meeting-management-board_en.pdf"},
    {"id":"13437","name":"Minutes of the sixty-first meeting of the Management Board: 11 December 2008","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2009-01-28T00:09:21Z","last_updated_date":"2009-01-28T00:09:21Z","reference_number":"EMEA/MB/671250/2008 Adopted","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-sixty-first-meeting-management-board-11-december-2008_en.pdf"},
    {"id":"13440","name":"Presentation - Session 4 – Testing with EMA new process","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-12T12:30:00Z","last_updated_date":"2016-05-12T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-testing-ema-new-process_en.pdf"},
    {"id":"13441","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 10 May 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/HMPC/288516/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-10-may-2011_en.pdf"},
    {"id":"13445","name":"Final list of references supporting the assessment of Echinacea pallida (Nutt.) Nutt., radix - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-08-14T12:00:00Z","last_updated_date":"2018-08-14T12:00:00Z","reference_number":"EMA/HMPC/737378/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-echinacea-pallida-nutt-nutt-radix-revision-1_en.pdf"},
    {"id":"13449","name":"18th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-11-22T00:00:00Z","last_updated_date":"2001-11-22T00:00:00Z","reference_number":"EMEA/COMP/519/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/18th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"13450","name":"CHMP summary of positive opinion for Prasugrel_Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/CHMP/50933/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-prasugrel_mylan_en.pdf"},
    {"id":"13452","name":"Organisational matters - CHMP meeting 14-17 November 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-11-18T13:02:00Z","last_updated_date":"2011-11-18T13:02:00Z","reference_number":"EMA/CHMP/877158/2011","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-14-17-november-2011_en.pdf"},
    {"id":"13453","name":"Calcitonin salmon, synthetic analogue of eel calcitonin: List of nationally authorised medicinal products - PSUSA/00000494/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-11T02:00:00Z","last_updated_date":"2016-10-18T14:01:11Z","reference_number":"EMA/255959/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcitonin-salmon-synthetic-analogue-eel-calcitonin-list-nationally-authorised-medicinal-products-psusa00000494201506_en.pdf"},
    {"id":"13454","name":"Presentation - Session 2 - User, manufacturer and academic viewpoints","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-05T01:00:00Z","last_updated_date":"2013-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-user-manufacturer-and-academic-viewpoints_en.pdf"},
    {"id":"13455","name":"EMEA procedure for the collection of bank details","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-28T02:09:21Z","last_updated_date":"2006-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/emea-procedure-collection-bank-details_en.pdf"},
    {"id":"13456","name":"Presentation - Session 2.1: Working Group on GCP training","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-21-working-group-gcp-training_en.pdf"},
    {"id":"13458","name":"European medicines regulators agree a common, Europe-wide approach for the identification of commercially confidential information and personal data","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-27T12:15:00Z","last_updated_date":"2012-03-27T12:15:00Z","reference_number":"EMA/211884/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-regulators-agree-common-europe-wide-approach-identification-commercially-confidential-information-and-personal-data_en.pdf"},
    {"id":"13460","name":"Technical Specifications: Procurement procedure EMA/2014/01/PH","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"EMA/37891/2014","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-procurement-procedure-ema201401ph_en.pdf"},
    {"id":"13461","name":"EU/3/18/1992: Public summary of opinion on orphan designation: Efgartigimod alfa for the treatment of myasthenia gravis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"EMA/139668/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181992-public-summary-opinion-orphan-designation-efgartigimod-alfa-treatment-myasthenia-gravis_en.pdf"},
    {"id":"13462","name":"Draft list of references for assessment of: Urticae folium Urtica dioica L.; Urtica urens L., folium (nettle leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-05-08T02:00:00Z","last_updated_date":"2008-05-08T02:00:00Z","reference_number":"EMEA/HMPC/4252/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-urticae-folium-urtica-dioica-l-urtica-urens-l-folium-nettle-leaf_en.pdf"},
    {"id":"13463","name":"Report on workshop on the development of an EMEA transparency policy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"EMEA/665540/2008","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-development-emea-transparency-policy_en.pdf"},
    {"id":"13466","name":"Finasteride : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001392/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-30T19:05:00Z","last_updated_date":"2017-05-30T19:15:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001392201608_sv.pdf","is":"https://www.ema.europa.eu/is/documents/psusa/finasteride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-im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    {"id":"13468","name":"EU/3/07/453: Public summary of positive opinion for orphan designation of recombinant fusion protein consisting of human coagulation factor IX  attached to the Fc domain of human IgG1 for the treatment of haemophilia B (...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMEA/COMP/138804/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307453-public-summary-positive-opinion-orphan-designation-recombinant-fusion-protein-consisting-human-coagulation-factor-ix-attached-fc-domain-human-igg1-treatment-haemophilia-b_en.pdf"},
    {"id":"13473","name":"Annual accounts: Financial year 2008","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-11-24T00:09:21Z","last_updated_date":"2009-11-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/annual-accounts-financial-year-2008_en.pdf"},
    {"id":"13474","name":"VICH GL50 Overview of comments: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-05-29T12:30:00Z","last_updated_date":"2015-05-29T12:30:00Z","reference_number":"VICH GL-50","document_url":"https://www.ema.europa.eu/en/documents/comments/vich-gl50-overview-comments-harmonisation-criteria-waive-target-animal-batch-safety-testing-inactivated-vaccines-veterinary-use-first-version_en.pdf"},
    {"id":"13475","name":"Superseded final list of references for assessment of: Hippocastani semen  Aesculus hippocastanum L., semen (horse chestnut seed) - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2020-04-23T02:00:00Z","reference_number":"EMEA/HMPC/225629/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-references-assessment-hippocastani-semen-aesculus-hippocastanum-l-semen-horse-chestnut-seed-first-version_en.pdf"},
    {"id":"13476","name":"Standard operating procedure for evaluation procedure for eligibility of patients', consumers' and healthcare professionals’ organisations","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2013-02-04T11:20:00Z","last_updated_date":"2015-03-17T11:10:00Z","reference_number":"SOP/H/3390","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-evaluation-procedure-eligibility-patients-consumers-and-healthcare-professionals-organisations_en.pdf"},
    {"id":"13477","name":"Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201607","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-13T15:00:00Z","last_updated_date":"2017-02-13T18:29:31Z","reference_number":"EMA/89247/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ibuprofen-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa00001711201607_en.pdf"},
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    {"id":"13490","name":"CHMP post-authorisation summary of positive opinion for Xalkori","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/488316/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xalkori_en.pdf"},
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    {"id":"13501","name":"Caustinerf arsenical and Yranicid arsenical Article-31 referral - Authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures revoked in the European 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    {"id":"13509","name":"Presentation - Pandemic lessons learnt","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pandemic-lessons-learnt_en.pdf"},
    {"id":"13510","name":"Pramiracetam: List of nationally authorised medicinal products - PSUSA/00002492/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-07T12:00:00Z","last_updated_date":"2016-10-17T18:48:34Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/pramiracetam-list-nationally-authorised-medicinal-products-psusa00002492201409_en.pdf"},
    {"id":"13511","name":"EMEA reports strong performance in regulatory and public-health activities in 2007; the outlook for 2008 is even higher application numbers and a focus on advanced-therapy medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-10T00:09:21Z","last_updated_date":"2008-03-10T00:09:21Z","reference_number":"EMEA/MB/117248/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-reports-strong-performance-regulatory-and-public-health-activities-2007-outlook-2008-even-higher-application-numbers-and-focus-advanced-therapy-medicines_en.pdf"},
    {"id":"13512","name":"Cefuroxime sodium (except for intracameral use): List of nationally authorised medicinal products - PSUSA/00000615/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T15:36:00Z","last_updated_date":"2018-01-26T15:44:00Z","reference_number":"EMA/PRAC/773016/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefuroxime-sodium-except-intracameral-use-list-nationally-authorised-medicinal-products-psusa00000615201704_en.pdf"},
    {"id":"13513","name":"Nicardipine Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T02:00:00Z","last_updated_date":"2014-03-12T13:00:00Z","reference_number":"Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/nicardipine-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nicardipine-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nicardipine-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nicardipine-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nicardipine-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nicardipine-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nicardipine-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nicardipine-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nicardipine-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nicardipine-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nicardipine-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nicardipine-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nicardipine-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nicardipine-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nicardipine-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nicardipine-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nicardipine-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nicardipine-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nicardipine-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nicardipine-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nicardipine-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nicardipine-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nicardipine-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"13514","name":"Presentation - Revatio in paediatric pulmonary arterial hypertension, an orphan indication - Break-out session 3 theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revatio-paediatric-pulmonary-arterial-hypertension-orphan-indication-break-out-session-3-theme-2_en.pdf"},
    {"id":"13516","name":"Arepanrix: Summary of product characteristics","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-29T02:00:00Z","last_updated_date":"2010-03-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/arepanrix-summary-product-characteristics_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/arepanrix-summary-product-characteristics_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/arepanrix-summary-product-characteristics_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/arepanrix-summary-product-characteristics_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/arepanrix-summary-product-characteristics_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/arepanrix-summary-product-characteristics_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/arepanrix-summary-product-characteristics_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/arepanrix-summary-product-characteristics_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/arepanrix-summary-product-characteristics_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/arepanrix-summary-product-characteristics_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/arepanrix-summary-product-characteristics_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/arepanrix-summary-product-characteristics_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/arepanrix-summary-product-characteristics_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/arepanrix-summary-product-characteristics_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/arepanrix-summary-product-characteristics_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/arepanrix-summary-product-characteristics_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/arepanrix-summary-product-characteristics_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/arepanrix-summary-product-characteristics_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/arepanrix-summary-product-characteristics_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/arepanrix-summary-product-characteristics_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/arepanrix-summary-product-characteristics_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/arepanrix-summary-product-characteristics_sv.pdf"}},
    {"id":"13517","name":"Superseded assessment report on Cassia senna L. and Cassia angustifolia Vahl, folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-04-27T02:09:00Z","last_updated_date":"2007-04-27T02:09:00Z","reference_number":"EMEA/HMPC/51868/2006 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-cassia-senna-l-and-cassia-angustifolia-vahl-folium_en.pdf"},
    {"id":"13521","name":"Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Parecoxib, Rofecoxib or Valdecoxib International Non-Proprietary Name (INN): celecoxib: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-04-30T02:08:21Z","last_updated_date":"2004-04-30T02:08:21Z","reference_number":"EMEA/CPMP/1747/04","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-all-medicinal-products-containing-celecoxib-etoricoxib-parecoxib-rofecoxib-or-valdecoxib-international-non-proprietary-name-inn-celecoxib-background-information_en.pdf"},
    {"id":"13524","name":"Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-13T13:00:00Z","last_updated_date":"2018-09-13T13:02:43Z","reference_number":"EMA/613929/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/celecoxib-list-nationally-authorised-medicinal-products-psusa00000616201712_en.pdf"},
    {"id":"13525","name":"Presentation - Public hearings","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:08Z","last_updated_date":"2011-06-24T22:06:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-hearings_en.pdf-0"},
    {"id":"13526","name":"CVMP summary of positive opinion for Equisolon","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-17T01:00:00Z","last_updated_date":"2014-01-17T01:00:00Z","reference_number":"EMA/CVMP/570503/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-equisolon_en.pdf"},
    {"id":"13527","name":"C(2005)1884: Public summary of negative opinion for orphan designation of ibuprofen L-lysinate for the treatment of patent ductus arteriosus in premature neonates\n\nof less than 34 weeks of gestational age","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-11T02:00:00Z","last_updated_date":"2005-10-11T02:00:00Z","reference_number":"EMEA/COMP/130896/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/c20051884-public-summary-negative-opinion-orphan-designation-ibuprofen-l-lysinate-treatment-patent-ductus-arteriosus-premature-neonates-less-34-weeks-gestational-age_en.pdf"},
    {"id":"13528","name":"Committee for medicinal products for human use, summary of positive opinion for  Tadalafil Lilly","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/304729/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-tadalafil-lilly_en.pdf"},
    {"id":"13529","name":"Summary report - EMA hosts workshop on adaptive pathways","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T01:00:00Z","last_updated_date":"2016-12-13T01:00:00Z","reference_number":"EMA/824492/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/summary-report-ema-hosts-workshop-adaptive-pathways_en.pdf"},
    {"id":"13531","name":"Draft assessment report on Rhodiola rosea - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-09-20T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"EMA/HMPC/232100/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-rhodiola-rosea-first-version_en.pdf"},
    {"id":"13532","name":"European Medicines Agency-Food and Drug Administration pilot programme for parallel assessment of quality-by-design applications: lessons learnt and questions and answers resulting from the first parallel assessment","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-20T17:00:00Z","last_updated_date":"2013-08-20T17:00:00Z","reference_number":"EMA/430501/2013","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-food-and-drug-administration-pilot-programme-parallel-assessment-quality-design-applications-lessons-learnt-and-questions-and-answers-resulting-first-parallel-assessment_en.pdf"},
    {"id":"13533","name":"Procedure for notifications of parallel distribution of centrally authorised medicinal products","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2003-04-01T02:00:00Z","last_updated_date":"2003-04-01T02:00:00Z","reference_number":"EMEA-H-30313-98 - Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-notifications-parallel-distribution-centrally-authorised-medicinal-products_en.pdf"},
    {"id":"13536","name":"Presentation - Session 5: Considerations in development of pembrolizumab in msi-h cancers (Christine Gause)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-considerations-development-pembrolizumab-msi-h-cancers-christine-gause_en.pdf"},
    {"id":"13537","name":"Presentation - Eligibility issues and meeting opportunities (Fia Westerholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eligibility-issues-and-meeting-opportunities-fia-westerholm_en.pdf"},
    {"id":"13538","name":"Trimetazidine - Article 31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T02:00:00Z","last_updated_date":"2012-10-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/trimetazidine-article-31-referral-assessment-report_en.pdf"},
    {"id":"13539","name":"EU/3/02/092: Public summary of positive opinion for orphan designation of 4-(3,5-bis-(hydroxy-phenyl)-1,2,4) triazol-1-yl)-benzoic acid for the treatment of chronic iron overload requiring chelation therapy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2016-09-30T02:00:00Z","reference_number":"EMEA/COMP/50/02 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302092-public-summary-positive-opinion-orphan-designation-4-35-bis-hydroxy-phenyl-124-triazol-1-yl-benzoic-acid-treatment-chronic-iron-overload-requiring-chelation-therapy_en.pdf"},
    {"id":"13540","name":"Withdrawal assessment report for Ramvocid","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-12-22T01:00:00Z","last_updated_date":"2009-12-22T01:00:00Z","reference_number":"EMA/571673/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ramvocid_en.pdf"},
    {"id":"13542","name":"Questions and answers on Okrido (prednisolone sodium phosphate, oral solution, 6 mg/ml)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2014-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-okrido-prednisolone-sodium-phosphate-oral-solution-6-mgml_sv.pdf"}},
    {"id":"13543","name":"CHMP summary of positive opinion for Imatinib Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/250071/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imatinib-accord_en.pdf"},
    {"id":"13544","name":"Gadolinium Article-31 referral – PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T13:00:00Z","last_updated_date":"2017-04-07T14:00:00Z","reference_number":"EMA/157486/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-prac-concludes-assessment-gadolinium-agents-used-body-scans-and-recommends-regulatory-actions-including-suspension-some-marketing-authorisations_en.pdf"},
    {"id":"13547","name":"EU/3/15/1458: Public summary of positive opinion for orphan designation of humanised anti-folate receptor 1 monoclonal antibody conjugated to maytansinoid DM4 for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/118047/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151458-public-summary-positive-opinion-orphan-designation-humanised-anti-folate-receptor-1-monoclonal-antibody-conjugated-maytansinoid-dm4-treatment-ovarian-cancer_en.pdf"},
    {"id":"13548","name":"Emergency contraceptives Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-06T16:00:00Z","last_updated_date":"2014-08-06T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/emergency-contraceptives-article-31-referral-annex-iii_en.pdf"},
    {"id":"13551","name":"Creating Biomedical R&D Leadership for Europeto Benefit Patients and Society - Karima Boubekeur","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/creating-biomedical-rd-leadership-europeto-benefit-patients-and-society-karima-boubekeur_en.pdf"},
    {"id":"13553","name":"PROTECT: key results and recommendations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-04-04T17:00:00Z","last_updated_date":"2016-04-04T17:00:00Z","reference_number":"EMA/180815/2016","document_url":"https://www.ema.europa.eu/en/documents/other/protect-key-results-and-recommendations_en.pdf"},
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    {"id":"13565","name":"Hydroxyethyl starch Article-107i referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMA/PRAC/691228/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-prac-list-questions_en.pdf"},
    {"id":"13568","name":"EU/3/03/147: Public summary of positive opinion for orphan designation of amiloride hydrochloride dihydrate for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/1186/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303147-public-summary-positive-opinion-orphan-designation-amiloride-hydrochloride-dihydrate-treatment-cystic-fibrosis_en.pdf"},
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    {"id":"13574","name":"Presentation - Direct patient reporting: the Dutch case","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:10Z","last_updated_date":"2011-06-24T22:06:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-direct-patient-reporting-dutch-case_en.pdf"},
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    {"id":"13594","name":"Agenda - CAT agenda of the 15-17 March 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-03-17T10:10:00Z","last_updated_date":"2017-03-17T10:10:00Z","reference_number":"EMA/CAT/185409/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-17-march-2017-meeting_en.pdf"},
    {"id":"13596","name":"Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-12T01:00:00Z","last_updated_date":"2007-11-12T01:00:00Z","reference_number":"EMEA/CVMP/EWP/005/2000 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestation-dogs-and-cats-revision-2_en.pdf"},
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    {"id":"13601","name":"Guideline on clinical investigation of medicinal products in the treatment of hypertension - Revision 4","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-08T12:50:00Z","last_updated_date":"2016-07-08T12:50:00Z","reference_number":"EMA/CHMP/29947/2013/Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-hypertension-revision-4_en.pdf"},
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    {"id":"13617","name":"Brief summary of the existing systems on collecting data: Switzerland","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-switzerland_en.pdf"},
    {"id":"13620","name":"EMEA forecasts modest increase in applications in its 2004 budget and Management Board elects new chairman","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-12-19T00:09:21Z","last_updated_date":"2003-12-19T00:09:21Z","reference_number":"EMEA/MB/73/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-forecasts-modest-increase-applications-its-2004-budget-and-management-board-elects-new-chairman_en.pdf"},
    {"id":"13621","name":"Mifepristone Article 29(4) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/mifepristone-article-294-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/mifepristone-article-294-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/mifepristone-article-294-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/mifepristone-article-294-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/mifepristone-article-294-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/mifepristone-article-294-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/mifepristone-article-294-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/mifepristone-article-294-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/mifepristone-article-294-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/mifepristone-article-294-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/mifepristone-article-294-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/mifepristone-article-294-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/mifepristone-article-294-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/mifepristone-article-294-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/mifepristone-article-294-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/mifepristone-article-294-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/mifepristone-article-294-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/mifepristone-article-294-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/mifepristone-article-294-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/mifepristone-article-294-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/mifepristone-article-294-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/mifepristone-article-294-referral-annex-i_sv.pdf"}},
    {"id":"13623","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 06-08 May 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/CVMP/243949/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-06-08-may-2014_en.pdf"},
    {"id":"13625","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - April 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-04-30T02:00:00Z","last_updated_date":"2009-04-30T02:00:00Z","reference_number":"EMEA/284966/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-april-2009_en.pdf"},
    {"id":"13627","name":"Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-06-12T02:00:00Z","reference_number":"EMA/180824/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-femara-and-associated-names-letrozole-25-mg-tablets_sv.pdf"}},
    {"id":"13628","name":"Withdrawal assessment report for Ibuprofen/Diphenhydramine Hydrochloride Wyeth","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-04-20T02:00:00Z","last_updated_date":"2010-04-20T02:00:00Z","reference_number":"EMA/CHMP/239978/2010","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ibuprofendiphenhydramine-hydrochloride-wyeth_en.pdf"},
    {"id":"13629","name":"Dexamed and associated names Article-29(4) referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-02T02:00:00Z","last_updated_date":"2014-09-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iv_sv.pdf"}},
    {"id":"13630","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris, November 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-06-14T17:00:00Z","last_updated_date":"2018-06-14T17:00:00Z","reference_number":"Course # 18521","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-paris-november-2018_en.pdf"},
    {"id":"13631","name":"EU/3/01/073: Public summary of positive opinion for orphan designation of recombinant human monoclonal antibody to hsp90 for the treatment of invasive fungal infections","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T00:00:00Z","last_updated_date":"2015-02-12T13:00:00Z","reference_number":"EMA/COMP/97241/2009 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301073-public-summary-positive-opinion-orphan-designation-recombinant-human-monoclonal-antibody-hsp90-treatment-invasive-fungal-infections_en.pdf"},
    {"id":"13632","name":"Declaration of interests: Yannis Hagiyannakis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:06:56Z","last_updated_date":"2017-08-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-yannis-hagiyannakis_en.pdf"},
    {"id":"13633","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 September 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-09-11T16:00:00Z","last_updated_date":"2015-09-14T16:00:00Z","reference_number":"EMA/CVMP/578106/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-september-2015_en.pdf"},
    {"id":"13634","name":"Nominations to the European Union Telematics governance bodies","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-23T14:55:00Z","last_updated_date":"2021-02-18T13:53:00Z","reference_number":"EMA/477872/2016","document_url":"https://www.ema.europa.eu/en/documents/other/nominations-european-union-telematics-governance-bodies_en.pdf"},
    {"id":"13638","name":"C(2004) 3227: Public summary of negative opinion for orphan designation of histamine dihydrochloride for the treatment of malignant melanoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-03-16T00:00:00Z","last_updated_date":"2005-03-16T00:00:00Z","reference_number":"EMEA/COMP/17/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/c2004-3227-public-summary-negative-opinion-orphan-designation-histamine-dihydrochloride-treatment-malignant-melanoma_en.pdf"},
    {"id":"13639","name":"Presentation: The EU Clinical Trial Regulation and children and young people (minors) - Ethical and procedural issues","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-clinical-trial-regulation-and-children-and-young-people-minors-ethical-and-procedural-issues_en.pdf"},
    {"id":"13640","name":"Corlentor and Procoralan Article-20 procedure - PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-11-07T13:00:00Z","last_updated_date":"2014-11-07T13:00:00Z","reference_number":"EMA/676096/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/corlentor-and-procoralan-article-20-procedure-prac-recommends-measures-reduce-risk-heart-problems-corlentorprocoralan-ivabradine_en.pdf"},
    {"id":"13641","name":"EU/3/10/825: Public summary of opinion on orphan designation: Ovine anti-colchicine polyclonal antibody fragments for the treatment of colchicine poisoning","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2013-06-25T02:00:00Z","reference_number":"EMA/COMP/662959/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310825-public-summary-opinion-orphan-designation-ovine-anti-colchicine-polyclonal-antibody-fragments-treatment-colchicine-poisoning_en.pdf"},
    {"id":"13644","name":"EU/3/06/392: Public summary of positive opinion for orphan designation of\n\nhuman monoclonal antibody against inhibitory killer cell lg-like receptors for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2014-01-13T15:30:00Z","reference_number":"EMEA/COMP/174047/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306392-public-summary-positive-opinion-orphan-designation-human-monoclonal-antibody-against-inhibitory-killer-cell-lg-receptors-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"13646","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Allogeneic peripheral blood mononuclear cells induced to an early apoptotic state","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T17:00:00Z","last_updated_date":"2015-03-02T17:00:00Z","reference_number":"EMA/108192/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-peripheral-blood-mononuclear-cells-induced-early-apoptotic-state_en.pdf"},
    {"id":"13649","name":"VICH GL37: Safety of veterinary drugs in human food repeat-dose (Chronic) toxicity testing - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-16T02:00:00Z","last_updated_date":"2004-06-16T02:00:00Z","reference_number":"CVMP/VICH/468/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl37-safety-veterinary-drugs-human-food-repeat-dose-chronic-toxicity-testing-step-7_en.pdf"},
    {"id":"13654","name":"12th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1996-06-27T14:39:21Z","last_updated_date":"1996-06-27T14:39:21Z","reference_number":"EMEA/CVMP/114/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/12th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13655","name":"Work instructions for European Pharmacovigilance Issues Tracking Tool (EPITT) user registration and management – Assessment of eligibility for an EPITT account","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-04-14T02:00:00Z","last_updated_date":"2016-10-27T16:05:00Z","reference_number":"WIN/H/3367","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-european-pharmacovigilance-issues-tracking-tool-epitt-user-registration-and-management-assessment-eligibility-epitt-account_en.pdf"},
    {"id":"13656","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev. 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-12T12:30:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/646647/2017","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-module-xv-safety-communication-rev-1_en.pdf"},
    {"id":"13659","name":"CHMP post authorisation summary of positive opinion for Abilify on 27 July 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-07-27T02:00:00Z","last_updated_date":"2009-07-27T02:00:00Z","reference_number":"EMEA/483040/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abilify-27-july-2009_en.pdf"},
    {"id":"13660","name":"Dates for submission of requests for ITF briefing meetings & regulatory advice\n\n2006-2008","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-27T02:00:00Z","last_updated_date":"2006-09-27T02:00:00Z","reference_number":"EMEA/385684/2006","document_url":"https://www.ema.europa.eu/en/documents/other/dates-submission-requests-itf-briefing-meetings-regulatory-advice-2006-2008_en.pdf"},
    {"id":"13661","name":"Presentation - Epidemiology as an enabler for health (Alison Cave)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/presentation-epidemiology-enabler-health-alison-cave_en.pdf"},
    {"id":"13662","name":"Overview of comments received on 'Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population’","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-28T10:30:00Z","last_updated_date":"2012-02-28T10:30:00Z","reference_number":"EMA/HMPC/354690/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-necessity-initiatives-stimulate-conduct-clinical-studies-herbal-medicinal-products-paediatric-population_en.pdf"},
    {"id":"13663","name":"Agenda - European Medicines Agency veterinary medicines info day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T12:00:00Z","last_updated_date":"2017-03-27T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-veterinary-medicines-info-day_en.pdf"},
    {"id":"13664","name":"Presentation - ALIMS web portal (Igor Vanevski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-alims-web-portal-igor-vanevski_en.pdf"},
    {"id":"13665","name":"Draft guideline on missing data in confirmatory clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-04-13T02:00:00Z","last_updated_date":"2009-04-13T02:00:00Z","reference_number":"CPMP/EWP/1776/99 Rev. 1 Corr*","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-missing-data-confirmatory-clinical-trials_en.pdf"},
    {"id":"13666","name":"EU/3/12/955: Public summary of opinion on orphan designation: Doxycycline hyclate for the treatment of familial amyloid polyneuropathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/COMP/15933/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312955-public-summary-opinion-orphan-designation-doxycycline-hyclate-treatment-familial-amyloid-polyneuropathy_en.pdf"},
    {"id":"13670","name":"Valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpromide/valproate bismuth / calcium valproate / valproate magnesium: List of nationally authorised medicinal products - PSUSA/00003090/2015...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-03T13:00:00Z","last_updated_date":"2016-10-17T20:16:34Z","reference_number":"EMA/727149/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/valproic-acid-sodium-valproate-valproate-pivoxil-valproate-semisodium-valpromidevalproate-bismuth-calcium-valproate-valproate-magnesium-list-nationally-authorised-medicinal-products-psusa000030902015_en.pdf"},
    {"id":"13671","name":"Wool alcohols: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/450/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/wool-alcohols-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13673","name":"Minutes - European network of paediatric research and the European Medicines Agency Coordinating Group meeting with chairs of the Working Groups","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-and-european-medicines-agency-coordinating-group-meeting-chairs-working-groups_en.pdf"},
    {"id":"13674","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T17:52:00Z","last_updated_date":"2017-06-15T17:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course_en.pdf"},
    {"id":"13676","name":"Presentation - The place for treatments and trial design considerations for associated neuropsychiatric symptoms in Alzheimer's disease (Rachel Schindler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-place-treatments-and-trial-design-considerations-associated-neuropsychiatric-symptoms-alzheimers-disease-rachel-schindler_en.pdf"},
    {"id":"13677","name":"Agenda - EMEA/DIA Joint Workshop on: EMEA new Guidelines for development and approval of Biosimilars","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2005-12-02T00:09:21Z","last_updated_date":"2005-12-02T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-emeadia-joint-workshop-emea-new-guidelines-development-and-approval-biosimilars_en.pdf"},
    {"id":"13678","name":"Lukasz Kniola (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/lukasz-kniola-cv_en.pdf"},
    {"id":"13679","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting -  May 2013","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"EMA/297283/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-may-2013_en.pdf"},
    {"id":"13680","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2016 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-03-02T13:00:00Z","last_updated_date":"2016-03-02T13:00:00Z","reference_number":"EMA/158306/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-february-2016-meeting_en.pdf"},
    {"id":"13683","name":"EU/3/06/380: Public summary of positive opinion for orphan designation of\n\ndiphenylcyclopropenone for the treatment of alopecia universalis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2013-09-23T02:00:00Z","reference_number":"EMEA/COMP/428296/2006 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306380-public-summary-positive-opinion-orphan-designation-diphenylcyclopropenone-treatment-alopecia-universalis_en.pdf"},
    {"id":"13685","name":"Presentation - Results from the questionnaire to PDCO members (Sofia Nordenmalm, Benjamin Pelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-results-questionnaire-pdco-members-sofia-nordenmalm-benjamin-pelle_en.pdf"},
    {"id":"13688","name":"Short-acting beta-agonists Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"EMA/PRAC/744203/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/short-acting-beta-agonists-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"13689","name":"Idea AG withdraws its marketing authorisation application for Diractin (ketoprofen)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/397710/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/idea-ag-withdraws-its-marketing-authorisation-application-diractin-ketoprofen_en.pdf"},
    {"id":"13690","name":"PRAC rapporteur PASS protocol amendment assessment report template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-11-30T14:34:00Z","last_updated_date":"2017-11-30T14:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/prac-rapporteur-pass-protocol-amendment-assessment-report-template_en.doc"},
    {"id":"13691","name":"EU/3/13/1158: Public summary of opinion on orphan designation: Dexamethasone sodium phosphate encapsulated in human autologous erythrocytes for the treatment of ataxia telangiectasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-16T02:00:00Z","last_updated_date":"2013-08-16T02:00:00Z","reference_number":"EMA/COMP/417562/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131158-public-summary-opinion-orphan-designation-dexamethasone-sodium-phosphate-encapsulated-human-autologous-erythrocytes-treatment-ataxia-telangiectasia_en.pdf"},
    {"id":"13693","name":"Guideline on the development of medicinal products for the treatment of alcohol dependence","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-03-01T01:00:00Z","last_updated_date":"2010-03-01T01:00:00Z","reference_number":"EMA/CHMP/EWP/20097/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-medicinal-products-treatment-alcohol-dependence_en.pdf"},
    {"id":"13694","name":"EU/3/15/1495: Public summary of opinion on orphan designation: Triheptanoin for the treatment of glucose transporter type-1 deficiency syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/COMP/269979/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151495-public-summary-opinion-orphan-designation-triheptanoin-treatment-glucose-transporter-type-1-deficiency-syndrome_en.pdf"},
    {"id":"13695","name":"EU/3/17/1883: Public summary of opinion on orphan designation: Pentamer formyl thiophene acetic acid for the treatment of Creutzfeldt-Jakob disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/312774/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171883-public-summary-opinion-orphan-designation-pentamer-formyl-thiophene-acetic-acid-treatment-creutzfeldt-jakob-disease_en.pdf"},
    {"id":"13696","name":"EU/3/03/183: Public summary of positive opinion for orphan designation of temocillin sodium for the treatment of Burkholderia cepacia lung infection in cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-09-23T02:00:00Z","last_updated_date":"2014-07-14T14:00:00Z","reference_number":"EMA/COMP/42574/2004 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303183-public-summary-positive-opinion-orphan-designation-temocillin-sodium-treatment-burkholderia-cepacia-lung-infection-cystic-fibrosis_en.pdf"},
    {"id":"13698","name":"European Medicines Agency and EUnetHTA three-year work plan","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T13:00:00Z","last_updated_date":"2013-11-19T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-and-eunethta-three-year-work-plan_en.pdf"},
    {"id":"13702","name":"Hydroquinidine : List of nationally authorised medicinal products - PSUSA/00001688/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-30T17:14:00Z","last_updated_date":"2017-10-30T17:16:14Z","reference_number":"EMA/722496/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroquinidine-list-nationally-authorised-medicinal-products-psusa00001688201703_en.pdf"},
    {"id":"13703","name":"Minutes of the European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ organisations (PCWP) meeting with all eligible organisations","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"EMA/1639/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"13704","name":"EU/3/11/933: Public summary of opinion on orphan designation: Nanoliposomal irinotecan for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/COMP/853906/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311933-public-summary-opinion-orphan-designation-nanoliposomal-irinotecan-treatment-pancreatic-cancer_en.pdf"},
    {"id":"13705","name":"Withdrawal assessment report for Sliwens","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-06-01T02:00:00Z","last_updated_date":"2010-06-01T02:00:00Z","reference_number":"EMA/CHMP/90435/2010","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-sliwens_en.pdf"},
    {"id":"13707","name":"CVMP summary of positive opinion for Cytopoint","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-02-17T01:00:00Z","last_updated_date":"2017-02-17T01:00:00Z","reference_number":"EMA/CVMP/44548/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-cytopoint_en.pdf"},
    {"id":"13708","name":"CHMP summary of positive opinion for Tasermity","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-12-19T01:00:00Z","last_updated_date":"2018-03-27T02:00:00Z","reference_number":"EMA/CHMP/761518/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tasermity_en.pdf"},
    {"id":"13710","name":"Superseded overview of comments received on community herbal monograph on Althaea officinalis L., radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2016-11-04T14:49:00Z","reference_number":"EMEA/HMPC/2920/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-althaea-officinalis-l-radix_en.pdf"},
    {"id":"13711","name":"Novartis Europharm Ltd withdraws its marketing authorisation application for Rasival (aliskiren / valsartan)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-09-17T16:43:38Z","last_updated_date":"2010-09-17T16:43:38Z","reference_number":"EMA/583880/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/novartis-europharm-ltd-withdraws-its-marketing-authorisation-application-rasival-aliskiren-valsartan_en.pdf"},
    {"id":"13713","name":"Introduction to nanotechnologies and medicinal products at the EMEA - Marisa Papaluca Amati","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-29T02:09:21Z","last_updated_date":"2009-04-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-nanotechnologies-and-medicinal-products-emea-marisa-papaluca-amati_en.pdf"},
    {"id":"13714","name":"Substance, product, organisation, referentials (SPOR) - Glossary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-15T19:00:00Z","last_updated_date":"2017-03-15T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/substance-product-organisation-referentials-spor-glossary_en.xlsx"},
    {"id":"13715","name":"Summary of European Union (EU) support to micro, small and medium-sized enterprises in health research: Horizon 2020 – The EU research and innovation programme for 2014-2020","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T17:38:23Z","last_updated_date":"2015-02-04T15:30:00Z","reference_number":"EMA/748291/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-european-union-eu-support-micro-small-and-medium-sized-enterprises-health-research-horizon-2020-eu-research-and-innovation-programme-2014-2020_en.pdf"},
    {"id":"13717","name":"Final European Union recommendations for the influenza-vaccine composition for the season 2002 / 2003","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-03-21T00:09:21Z","last_updated_date":"2002-03-21T00:09:21Z","reference_number":"CPMP/BWP/852/02","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/final-european-union-recommendations-influenza-vaccine-composition-season-2002-2003_en.pdf"},
    {"id":"13719","name":"Questions and answers on refusal of the marketing authorisation for Labazenit","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T01:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/177112/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-labazenit_en.pdf"},
    {"id":"13722","name":"Summary of the evaluation of the proposed paediatric investigation plan: Brodalumab for treatment of psoriasis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/615052/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-brodalumab-treatment-psoriasis_en.pdf"},
    {"id":"13723","name":"Public statement on Pulsaflox oral solution (difloxaxin): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-03-04T00:09:21Z","last_updated_date":"2004-03-04T00:09:21Z","reference_number":"EMEA/CVMP/021/04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pulsaflox-oral-solution-difloxaxin-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"13724","name":"Gadolinium Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/207286/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-annex-i_en.pdf"},
    {"id":"13725","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Dacogen (decitabine) for the treatment of acute myeloid leukaemia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-10-22T02:00:00Z","last_updated_date":"2012-10-22T02:00:00Z","reference_number":"EMA/COMP/558969/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-dacogen-decitabine-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"13727","name":"Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/631408/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_sv.pdf"}},
    {"id":"13728","name":"Rules for the implementation of the financial regulation applicable to the budget of the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-06-10T02:00:00Z","last_updated_date":"2014-10-08T15:00:00Z","reference_number":"EMA/MB/99010/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/rules-implementation-financial-regulation-applicable-budget-european-medicines-agency_en.pdf"},
    {"id":"13731","name":"Cilazapril Teva Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cilazapril-teva-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cilazapril-teva-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cilazapril-teva-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cilazapril-teva-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cilazapril-teva-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cilazapril-teva-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cilazapril-teva-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cilazapril-teva-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cilazapril-teva-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cilazapril-teva-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cilazapril-teva-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cilazapril-teva-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cilazapril-teva-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cilazapril-teva-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cilazapril-teva-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cilazapril-teva-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cilazapril-teva-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cilazapril-teva-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cilazapril-teva-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cilazapril-teva-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cilazapril-teva-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cilazapril-teva-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"13732","name":"Employee Assistance Programme and helpline","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2017-07-17T15:53:00Z","last_updated_date":"2017-07-17T15:53:00Z","reference_number":"EMA/452490/2017","document_url":"https://www.ema.europa.eu/en/documents/procurement/employee-assistance-programme-and-helpline_en.pdf"},
    {"id":"13735","name":"Selenicereus grandiflorus: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/601/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/selenicereus-grandiflorus-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13736","name":"Presentation - KEYTRUDA® (pembrolizumab): melanoma lessons learnt (Roger Dansey) - S2.2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-keytrudar-pembrolizumab-melanoma-lessons-learnt-roger-dansey-s22_en.pdf"},
    {"id":"13737","name":"CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Final advice","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag1-advice-european-medicines-agency-clinical-trial-advisory-group-protecting-patient-confidentiality-final-advice_en.pdf"},
    {"id":"13738","name":"Public statement on Ariclaim : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-08-07T18:40:00Z","last_updated_date":"2018-08-07T18:40:00Z","reference_number":"EMA/518555/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ariclaim-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"13740","name":"Declaration of interests: Nikolaus Kriz","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-08-08T02:00:00Z","last_updated_date":"2016-09-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-nikolaus-kriz_en.pdf"},
    {"id":"13741","name":"EU/3/05/309: Public summary of positive opinion for orphan designation of sodium valproate for the treatment of 5q spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T01:00:00Z","last_updated_date":"2014-01-13T01:00:00Z","reference_number":"EMEA/COMP/245336/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305309-public-summary-positive-opinion-orphan-designation-sodium-valproate-treatment-5q-spinal-muscular-atrophy_en.pdf"},
    {"id":"13742","name":"Final assessment report on Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/HMPC/674138/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus_en.pdf"},
    {"id":"13744","name":"Presentation - The role of PRAC in pharmacovigilance decisions (June M Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-prac-pharmacovigilance-decisions-june-m-raine_en.pdf"},
    {"id":"13745","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19–21 June 2018","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T18:00:00Z","last_updated_date":"2018-06-22T18:00:00Z","reference_number":"EMA/CVMP/404979/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-june-2018_en.pdf"},
    {"id":"13746","name":"Questions and answers on Clopidogrel Teva and associated names (clopidogrel 75 mg tablets)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-02-20T00:59:00Z","last_updated_date":"2011-09-09T01:59:00Z","reference_number":"EMA/103806/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-clopidogrel-teva-and-associated-names-clopidogrel-75-mg-tablets_sv.pdf"}},
    {"id":"13747","name":"Overview of comments received on draft guideline on the specification limits for residues of metal catalysts","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-05-26T02:00:00Z","last_updated_date":"2009-05-26T02:00:00Z","reference_number":"EMEA/410412/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-specification-limits-residues-metal-catalysts_en.pdf"},
    {"id":"13748","name":"CHMP summary of positive opinion for Venclyxto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-10-14T14:00:00Z","last_updated_date":"2016-10-14T14:00:00Z","reference_number":"EMA/CHMP/561089/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-venclyxto_en.pdf"},
    {"id":"13749","name":"CHMP post-authorisation summary of positive opinion for Lucentis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2011-03-18T01:00:00Z","reference_number":"EMA/CHMP/221398/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lucentis_en.pdf"},
    {"id":"13750","name":"Medication-errors workshop report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-05-13T12:30:00Z","last_updated_date":"2013-05-13T12:30:00Z","reference_number":"EMA/144458/2013","document_url":"https://www.ema.europa.eu/en/documents/report/medication-errors-workshop-report_en.pdf"},
    {"id":"13752","name":"Report of the CHMP working group on benefit-risk assessment models and methods","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-01-19T00:09:21Z","last_updated_date":"2007-01-19T00:09:21Z","reference_number":"EMEA/CHMP/15404/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/report-chmp-working-group-benefit-risk-assessment-models-and-methods_en.pdf"},
    {"id":"13754","name":"Agenda - Best expertise vs conflicts of interests: Striking the right balance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-07-19T17:20:00Z","last_updated_date":"2013-09-04T14:15:00Z","reference_number":"EMA/189739/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-best-expertise-vs-conflicts-interests-striking-right-balance_en.pdf"},
    {"id":"13755","name":"EU/3/12/1027: Public summary of opinion on orphan designation: Human apotransferrin for the treatment of congenital hypotransferrinaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-08-31T12:30:00Z","last_updated_date":"2012-08-31T12:30:00Z","reference_number":"EMA/COMP/424419/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121027-public-summary-opinion-orphan-designation-human-apotransferrin-treatment-congenital-hypotransferrinaemia_en.pdf"},
    {"id":"13757","name":"Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: List of nationally authorised medicinal products - PSUSA/00001696/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:40:00Z","last_updated_date":"2017-01-20T16:40:00Z","reference_number":"EMA/36356/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxyzine-chloride-hydroxyzine-pamoate-and-all-fixed-combination-hydroxyzine-list-nationally-authorised-medicinal-products-psusa00001696201605_en.pdf"},
    {"id":"13758","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 14 - 17 March 2005","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-03-17T01:00:00Z","last_updated_date":"2005-03-17T01:00:00Z","reference_number":"EMEA/96995/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-14-17-march-2005_en.pdf"},
    {"id":"13760","name":"EU/3/13/1103: Public summary of positive opinion of treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T11:00:00Z","last_updated_date":"2013-03-04T11:00:00Z","reference_number":"EMA/COMP/20734/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131103-public-summary-positive-opinion-treprostinil-sodium-treatment-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"13761","name":"CHMP summary of positive opinion for Tadalafil Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/CHMP/476904/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tadalafil-mylan_en.pdf"},
    {"id":"13762","name":"ICH guideline E18 on genomic sampling and management of genomic data - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-06T19:00:00Z","last_updated_date":"2017-10-06T19:00:00Z","reference_number":"EMA/CHMP/ICH/11623/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e18-genomic-sampling-and-management-genomic-data-step-5_en.pdf"},
    {"id":"13763","name":"Call for submission of scientific data on Serenoa repens (Bartram) Small (Sabal serrulata (Michaux) Nichols), fructus","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/HMPC/152363/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-serenoa-repens-bartram-small-sabal-serrulata-michaux-nichols-fructus_en.pdf"},
    {"id":"13764","name":"News bulletin for small and medium-sized enterprises - Issue 33","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-10-20T17:37:00Z","last_updated_date":"2015-10-20T17:37:00Z","reference_number":"Issue 33","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-33_en.pdf"},
    {"id":"13765","name":"Lansoprazol HEXAL 15 mg and 30 mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2005-10-13T02:08:21Z","last_updated_date":"2005-10-13T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lansoprazol-hexal-15-mg-and-30-mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"13767","name":"GVK Biosciences Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T13:00:00Z","last_updated_date":"2015-08-04T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gvk-biosciences-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gvk-biosciences-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gvk-biosciences-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gvk-biosciences-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gvk-biosciences-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gvk-biosciences-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gvk-biosciences-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gvk-biosciences-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gvk-biosciences-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gvk-biosciences-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gvk-biosciences-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gvk-biosciences-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gvk-biosciences-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gvk-biosciences-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gvk-biosciences-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gvk-biosciences-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gvk-biosciences-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gvk-biosciences-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gvk-biosciences-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gvk-biosciences-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gvk-biosciences-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gvk-biosciences-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/gvk-biosciences-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/gvk-biosciences-article-31-referral-annex-i_no.pdf"}},
    {"id":"13770","name":"Draft public statement on Centella asiatica (L.) Urban, herba - First version","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-09-17T02:09:21Z","last_updated_date":"2009-09-17T02:09:21Z","reference_number":"EMEA/HMPC/579663/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-centella-asiatica-l-urban-herba-first-version_en.pdf"},
    {"id":"13771","name":"Novantrone Article-30 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/novantrone-article-30-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/novantrone-article-30-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/novantrone-article-30-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/novantrone-article-30-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/novantrone-article-30-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/novantrone-article-30-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/novantrone-article-30-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/novantrone-article-30-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/novantrone-article-30-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/novantrone-article-30-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/novantrone-article-30-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/novantrone-article-30-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/novantrone-article-30-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/novantrone-article-30-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/novantrone-article-30-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/novantrone-article-30-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/novantrone-article-30-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/novantrone-article-30-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/novantrone-article-30-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/novantrone-article-30-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/novantrone-article-30-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/novantrone-article-30-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/novantrone-article-30-referral-annex-iv_sv.pdf"}},
    {"id":"13772","name":"Presentation - Experience with CF in scientific advice (Efthymios Manolis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-cf-scientific-advice-efthymios-manolis_en.pdf"},
    {"id":"13775","name":"Lobeline: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-03-01T01:00:00Z","last_updated_date":"1996-03-01T01:00:00Z","reference_number":"EMEA/MRL/070/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lobeline-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13778","name":"Questions and answers on the review aliskiren-containing medicines","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T12:00:00Z","last_updated_date":"2012-02-17T12:00:00Z","reference_number":"EMA/113677/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-aliskiren-containing-medicines_en.pdf"},
    {"id":"13779","name":"Withdrawal letter: Teysuno","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2015-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-teysuno_en.pdf"},
    {"id":"13782","name":"EU/3/16/1796: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 encoding engineered rhodopsin DNA-binding repressor and human rhodopsin expression cassettes for the treatment of re...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/747470/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161796-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-encoding-engineered-rhodopsin-dna-binding-repressor-and-human-rhodopsin-expression-cassettes-treatment-re_en.pdf"},
    {"id":"13787","name":"Carazolol (Extension to cattle): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/442/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/carazolol-extension-cattle-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13790","name":"Presentation - Conflicts of interest – industry view (Richard Bergstrom)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-conflicts-interest-industry-view-richard-bergstrom_en.pdf"},
    {"id":"13791","name":"EU/3/10/811: Public summary of opinion on orphan designation: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for the treatment o...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2013-04-09T02:00:00Z","reference_number":"EMA/COMP/601719/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310811-public-summary-opinion-orphan-designation-n-tert-butyl-3-5-methyl-2-4-2-pyrrolidin-1-ylethoxyphenylaminopyrimidin-4-ylamino-benzenesulfonamide-dihydrochloride-monohydrate-treatment-o_en.pdf"},
    {"id":"13795","name":"CVMP post-authorisation summary of positive opinion for Loxicom","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"EMA/CVMP/749848/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-loxicom_en.pdf-1"},
    {"id":"13797","name":"Withdrawal letter : Viagra","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-19T01:00:00Z","last_updated_date":"2008-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-viagra_en.pdf"},
    {"id":"13798","name":"Agenda – Tenth Stakeholder forum on the Pharmacovigilance legislation","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-09-14T17:00:00Z","last_updated_date":"2016-09-14T17:00:00Z","reference_number":"EMA/348709/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-tenth-stakeholder-forum-pharmacovigilance-legislation_en.pdf"},
    {"id":"13800","name":"European Medicines Agency: Committee for Medicinal Products for Human Use\n\n17-20 January 2005","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2004-01-20T01:00:00Z","last_updated_date":"2004-01-20T01:00:00Z","reference_number":"EMEA/21979/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-17-20-january-2005_en.pdf"},
    {"id":"13801","name":"List of organisations that provided comments during the public consultation on the European-Union-reference-date list","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-01T14:45:00Z","last_updated_date":"2012-11-05T11:00:02Z","reference_number":"EMA/632901/2012","document_url":"https://www.ema.europa.eu/en/documents/other/list-organisations-provided-comments-during-public-consultation-european-union-reference-date-list_en.pdf"},
    {"id":"13805","name":"Procedure for reporting of pharmacovigilance inspections requested by the CVMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-20T02:00:00Z","last_updated_date":"2014-12-17T16:05:00Z","reference_number":"EMEA/INS/PhV/226163/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-reporting-pharmacovigilance-inspections-requested-cvmp_en.pdf"},
    {"id":"13806","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic haptenized, stimulated and irradiated non-proliferative colorectal tumour whole cells derived from 3 colorectal cell lines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/416690/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-haptenized-stimulated-and-irradiated-non-proliferative-colorectal-tumour-whole-cells-derived-3-colorectal-cell_en.pdf"},
    {"id":"13807","name":"Withdrawal letter: Pioglitazone Teva Generics","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T13:20:00Z","last_updated_date":"2012-04-30T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-pioglitazone-teva-generics_en.pdf"},
    {"id":"13808","name":"Questions and answers on insurance broking service","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-12-06T01:00:00Z","last_updated_date":"2007-12-06T01:00:00Z","reference_number":"EMEA/580389/2007","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-insurance-broking-service_en.pdf"},
    {"id":"13809","name":"CVMP post-authorisation summary of positive opinion for Panacur AquaSol","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-01-17T01:00:00Z","last_updated_date":"2014-01-17T01:00:00Z","reference_number":"EMA/CVMP/735220/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-panacur-aquasol_en.pdf-0"},
    {"id":"13811","name":"Citronellae aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-04T01:00:00Z","last_updated_date":"2015-05-01T02:00:00Z","reference_number":"EMEA/MRL/408/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/citronellae-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13816","name":"EMEA statement on the safety of Ketek","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-01-27T01:00:00Z","last_updated_date":"2006-01-27T01:00:00Z","reference_number":"EMEA/29386/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-statement-safety-ketek_en.pdf"},
    {"id":"13817","name":"Presentation - Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports and process: Meeting on redacting commercially confidential information (CCI) in clinical re...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T02:00:00Z","last_updated_date":"2015-09-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-pharmaceutical-industry-redacting-commercially-confidential-information-cci-clinical-reports-and-process-meeting-redacting-commercially-confidential-information-cci-clinical-re_en.pdf"},
    {"id":"13819","name":"EU/3/13/1102: Public summary of positive opinion of Cyclo-Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys for the treatment of high-altitude pulmonary oedema","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T11:00:00Z","last_updated_date":"2013-03-04T11:00:00Z","reference_number":"EMA/COMP/39571/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131102-public-summary-positive-opinion-cyclo-cys-gly-gln-arg-glu-thr-pro-glu-gly-ala-glu-ala-lys-pro-trp-tyr-cys-treatment-high-altitude-pulmonary-oedema_en.pdf"},
    {"id":"13820","name":"Agenda - EMEA Workshop on the Guideline for first-in-man clinical trials for potential high-risk medicinal products","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2007-06-08T02:09:21Z","last_updated_date":"2007-06-08T02:09:21Z","reference_number":"EMEA/177203/2007","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-emea-workshop-guideline-first-man-clinical-trials-potential-high-risk-medicinal-products_en.pdf"},
    {"id":"13823","name":"Gadolinium Article-31 referral – PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-03-18T01:00:00Z","reference_number":"EMA/PRAC/188631/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"13824","name":"Lysine acetylsalicylate: List of nationally authorised medicinal products - PSUSA/00001921/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-24T18:00:00Z","last_updated_date":"2018-05-24T18:09:40Z","reference_number":"EMA/333539/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/lysine-acetylsalicylate-list-nationally-authorised-medicinal-products-psusa00001921201709_en.pdf"},
    {"id":"13825","name":"EU/3/06/367: Public summary of positive opinion for orphan designation of parathyroid hormone (1-34) transglutaminase fusion protein fibrin matrix complex for the treatment of solitary bone cysts","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/107517/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306367-public-summary-positive-opinion-orphan-designation-parathyroid-hormone-1-34-transglutaminase-fusion-protein-fibrin-matrix-complex-treatment-solitary-bone-cysts_en.pdf"},
    {"id":"13829","name":"COMP meeting report on the review of applications for orphan designation: February 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-03-04T13:50:00Z","last_updated_date":"2015-03-04T13:50:00Z","reference_number":"EMA/COMP/38966/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-february-2015_en.pdf"},
    {"id":"13830","name":"Summary report - Fifth annual regulatory conference organised by EBE, in collaboration with the European Medicines Agency (EMA) “Optimising the development of ATMPs to meet patient needs”","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-07T11:55:00Z","last_updated_date":"2017-02-07T11:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/summary-report-fifth-annual-regulatory-conference-organised-ebe-collaboration-european-medicines-agency-ema-optimising-development-atmps-meet-patient-needs_en.pdf"},
    {"id":"13831","name":"Levothyroxine Alapis - Article 29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2013-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/levothyroxine-alapis-article-294-referral-annex-ii_fi.pdf"}},
    {"id":"13833","name":"Committee for medicinal products for veterinary use: Meeting of 6 to 8 September 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-09-09T14:09:21Z","last_updated_date":"2005-09-09T14:09:21Z","reference_number":"EMEA/CVMP/257162/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-6-8-september-2005_en.pdf"},
    {"id":"13835","name":"Human medicines highlights - October 2013","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T12:00:00Z","last_updated_date":"2013-11-12T12:00:00Z","reference_number":"Issue 56","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-october-2013_en.pdf"},
    {"id":"13837","name":"EU/3/12/1057: Public summary of opinion on orphan designation: Naloxone hydrochloride dihydrate for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2012-12-12T01:00:00Z","reference_number":"EMA/COMP/684045/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121057-public-summary-opinion-orphan-designation-naloxone-hydrochloride-dihydrate-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"13839","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel Winthrop","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-05-06T02:00:00Z","last_updated_date":"2008-05-06T02:00:00Z","reference_number":"EMEA/CHMP/216044/2008-corr","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-winthrop_en.pdf"},
    {"id":"13840","name":"European Union reference instances","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-27T01:00:00Z","last_updated_date":"2017-08-02T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-reference-instances_en.zip"},
    {"id":"13842","name":"Valproate Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valproate-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valproate-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valproate-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valproate-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valproate-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valproate-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valproate-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valproate-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/valproate-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valproate-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valproate-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valproate-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valproate-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valproate-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valproate-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valproate-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valproate-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valproate-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valproate-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valproate-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valproate-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valproate-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"13845","name":"Presentation - Japanese Orphan Drug Designation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-17T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-japanese-orphan-drug-designation_en.pdf"},
    {"id":"13846","name":"CHMP summary of positive opinion for Veyvondi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"EMA/CHMP/324506/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-veyvondi_en.pdf"},
    {"id":"13847","name":"COMP meeting report on the review of applications for orphan designation: September 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-09-13T13:55:00Z","last_updated_date":"2012-09-13T13:55:00Z","reference_number":"EMA/COMP/548701/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-september-2012_en.pdf"},
    {"id":"13850","name":"Furosemide: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00001491/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-05T01:00:00Z","last_updated_date":"2016-10-18T13:42:40Z","reference_number":"EMA/729667/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/furosemide-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001491201501_en.pdf"},
    {"id":"13851","name":"Recommendation for removal of orphan designation at the time of marketing authorisation: Pheburane (sodium phenylbutyrate) for the treatment of urea-cycle disorders (carbamoyl-phosphate-synthase-1 deficiency, ornithine-t...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T14:00:00Z","last_updated_date":"2013-08-08T14:00:00Z","reference_number":"EMA/COMP/239416/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-removal-orphan-designation-time-marketing-authorisation-pheburane-sodium-phenylbutyrate-treatment-urea-cycle-disorders-carbamoyl-phosphate-synthase-1-deficiency-ornithine-t_en.pdf"},
    {"id":"13852","name":"Overview of comments received on 'Dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-06-26T13:46:00Z","last_updated_date":"2018-06-26T13:46:00Z","reference_number":"EMA/CHMP/258276/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-dabigatran-etexilate-hard-capsules-75-mg-110-mg-and-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"13854","name":"Carprofen: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/042/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/carprofen-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13856","name":"Electronic registration process – EudraVigilance registration phases I, II and III","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2019-10-31T12:00:00Z","reference_number":"EMA/101243/2016","document_url":"https://www.ema.europa.eu/en/documents/other/electronic-registration-process-eudravigilance-registration-phases-i-ii-and-iii_en.pdf"},
    {"id":"13857","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting -  February 2010","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-february-2010_en.pdf"},
    {"id":"13858","name":"Questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2017-10-06T19:00:00Z","last_updated_date":"2017-10-06T19:00:00Z","reference_number":"EMA/CHMP/ICH/809509/2016","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnological-biological-entities_en.pdf"},
    {"id":"13859","name":"Presentation - Introduction to population pharmacokinetic-pharmacodynamic modelling in paediatric clinical pharmacology","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-05-13T02:09:21Z","last_updated_date":"2008-05-13T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-population-pharmacokinetic-pharmacodynamic-modelling-paediatric-clinical-pharmacology_en.pdf"},
    {"id":"13861","name":"CVMP post-authorisation summary of positive opinion for Metacam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-04-16T02:00:00Z","last_updated_date":"2010-04-16T02:00:00Z","reference_number":"EMA/CVMP/140057/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam_en.pdf-2"},
    {"id":"13862","name":"EU/3/16/1667: Public summary of opinion on orphan designation: Rovalpituzumab tesirine for the treatment of small cell lung cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"EMA/COMP/303792/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161667-public-summary-opinion-orphan-designation-rovalpituzumab-tesirine-treatment-small-cell-lung-cancer_en.pdf"},
    {"id":"13863","name":"Questions and answers relating to tender – Information-technology service desk - EMA-2013-09-ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-12T17:10:00Z","last_updated_date":"2013-06-19T12:10:00Z","reference_number":"EMA-2013-09-ICT","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-tender-information-technology-service-desk-ema-2013-09-ict_en.pdf"},
    {"id":"13864","name":"Fludarabine: List of nationally authorised medicinal products - PSUSA/00001406/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T12:50:00Z","last_updated_date":"2018-04-13T12:52:09Z","reference_number":"EMA/223740/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fludarabine-list-nationally-authorised-medicinal-products-psusa00001406201708_en.pdf"},
    {"id":"13865","name":"European Medicines Agency recommends approval of combined advanced-therapy product","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:02Z","last_updated_date":"2013-04-26T14:00:02Z","reference_number":"EMA/256423/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-combined-advanced-therapy-product_en.pdf"},
    {"id":"13866","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n26-29 May 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:09:21Z","last_updated_date":"2009-05-29T02:09:21Z","reference_number":"EMEA/CHMP/330580/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-26-29-may-2009_en.pdf"},
    {"id":"13867","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/CHMP/819015/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-17-20-january-2011_en.pdf"},
    {"id":"13868","name":"Calcium chloride/ glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00009162/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T01:00:00Z","last_updated_date":"2016-10-18T15:41:00Z","reference_number":"EMA/829696/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-chloride-glutamic-acid-glutathione-histidine-lactobionic-acid-magnesium-chloride-mannitol-potassium-chloride-sodium-hydroxide-list-nationally-authorised-medicinal-products-psusa00009162201503_en.pdf"},
    {"id":"13869","name":"Draft list of references supporting the assessment of Fucus vesiculosus L., thallus","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-08-19T02:00:00Z","last_updated_date":"2013-08-19T02:00:00Z","reference_number":"EMA/HMPC/313673/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-fucus-vesiculosus-l-thallus_en.pdf"},
    {"id":"13870","name":"Module 10 - Presentation - Stakeholders engagement","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/module-10-presentation-stakeholders-engagement_en.pdf"},
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    {"id":"13895","name":"Standard operating procedure for provision of scientific recommendation on classification of advanced-therapy medicinal products","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2011-11-07T12:40:00Z","last_updated_date":"2016-06-10T14:48:00Z","reference_number":"SOP/H/3309","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-provision-scientific-recommendation-classification-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"13896","name":"EU/3/06/386: Public summary of positive opinion for orphan designation\n\nof 4-[123I] iodo-L-phenylalanine for the diagnosis of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/159728/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306386-public-summary-positive-opinion-orphan-designation-4-123i-iodo-l-phenylalanine-diagnosis-glioma_en.pdf"},
    {"id":"13898","name":"EU/3/13/1223: Public summary of opinion on orphan designation: Inecalcitol for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/COMP/16735/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131223-public-summary-opinion-orphan-designation-inecalcitol-treatment-chronic-lymphocytic-leukaemia-small-lymphocytic-lymphoma_en.pdf"},
    {"id":"13901","name":"Standard operating procedure for co-ordination of good-laboratory-practice inspections","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-27T18:30:00Z","last_updated_date":"2012-09-27T18:30:00Z","reference_number":"SOP/INSP/2049","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-co-ordination-good-laboratory-practice-inspections_en.pdf"},
    {"id":"13903","name":"Presentation - Standards of care in SMA and implications for clinical trials (Richard Finkel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-standards-care-sma-and-implications-clinical-trials-richard-finkel_en.pdf"},
    {"id":"13904","name":"Hydroxyzine Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T01:00:00Z","last_updated_date":"2015-06-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyzine-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyzine-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyzine-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyzine-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyzine-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyzine-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyzine-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyzine-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyzine-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyzine-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyzine-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/hydroxyzine-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyzine-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyzine-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyzine-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyzine-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyzine-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyzine-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyzine-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyzine-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyzine-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyzine-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/hydroxyzine-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/hydroxyzine-article-31-referral-annex-iii_no.pdf"}},
    {"id":"13909","name":"Overview of comments on 'Total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-11-13T17:20:00Z","last_updated_date":"2015-11-13T17:20:00Z","reference_number":"EMA/733775/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-total-kidney-volume-tkv-prognostic-biomarker-use-clinical-trials-evaluating-patients-autosomal-dominant-polycystic-kidney-disease-adpkd_en.pdf"},
    {"id":"13910","name":"Standard operating procedure on data analysis of EudraVigilance","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T02:00:00Z","last_updated_date":"2019-01-07T09:35:00Z","reference_number":"SOP/H/3289","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-data-analysis-eudravigilance_en.pdf"},
    {"id":"13912","name":"Overview of comments received by EMA on the draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-04-26T15:44:00Z","last_updated_date":"2017-04-28T18:46:00Z","reference_number":"EMA/256626/2017 Corr.","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ema-draft-addendum-ich-e11r1-guideline-clinical-investigation-medicinal-products-paediatric-population-emacpmpich27111999_en.pdf"},
    {"id":"13913","name":"Final list of references supporting the assessment of Taraxacum officinale Weber ex Wigg., radix cum herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/HMPC/212894/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf"},
    {"id":"13914","name":"Tecfidera: Product Information as approved by the CHMP on 5 November 2015, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-09T12:54:00Z","last_updated_date":"2015-11-09T12:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/tecfidera-product-information-approved-chmp-5-november-2015-pending-endorsement-european-commission_en.pdf"},
    {"id":"13915","name":"Language skills self assessment grid","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-04-03T02:09:21Z","last_updated_date":"2007-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/language-skills-self-assessment-grid_en.pdf"},
    {"id":"13916","name":"Committee for Orphan Medicinal Products: December 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-12-09T01:00:00Z","last_updated_date":"2005-12-09T01:00:00Z","reference_number":"EMEA/COMP/412637/2005 Corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-december-2005-meeting_en.pdf"},
    {"id":"13917","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Adempas (riociguat) for the treatment of pulmonary arterial hypertension including chronic thromboembolic pulmonary hypertensio...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-04-24T12:30:00Z","last_updated_date":"2022-06-14T12:30:00Z","reference_number":"EMA/COMP/68649/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-adempas-riociguat-treatment-pulmonary-arterial-hypertension-including-chronic-thromboembolic-pulmonary-hypertensio_en.pdf"},
    {"id":"13919","name":"CVMP summary of positive opinion for Ecoporc Shiga","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T01:00:00Z","last_updated_date":"2013-02-08T01:00:00Z","reference_number":"EMA/CVMP/15924/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-ecoporc-shiga_en.pdf"},
    {"id":"13920","name":"ICH: Q 4 B Annex 2: To note evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-11-01T01:00:00Z","last_updated_date":"2007-11-01T01:00:00Z","reference_number":"EMEA/CHMP/ICH/559409/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-2-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-test-extractable-volume-parenteral-preparations-general-chapter-step-3_en.pdf"},
    {"id":"13921","name":"Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord  seeded on acellular dermal matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T17:00:00Z","last_updated_date":"2016-04-12T17:00:00Z","reference_number":"EMA/241004/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-co-culture-keratinocytes-and-mesenchymal-stem-cells-isolated-umbilical-cord-seeded-acellular-dermal-matrix_en.pdf"},
    {"id":"13924","name":"Valproate Article-31 referral - New measures to avoid valproate exposure in pregnancy endorsed","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/145600/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-new-measures-avoid-valproate-exposure-pregnancy-endorsed_en.pdf"},
    {"id":"13926","name":"European Medicines Agency updates on ongoing safety review of sibutramine: Weight-loss medicine assessed over cardiovascular concerns","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-18T01:00:00Z","last_updated_date":"2009-12-18T01:00:00Z","reference_number":"EMA/CHMP/817876/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-updates-ongoing-safety-review-sibutramine-weight-loss-medicine-assessed-over-cardiovascular-concerns_en.pdf"},
    {"id":"13927","name":"Strychni semen: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/566/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/strychni-semen-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13928","name":"Presentation - Manufacturing challenges - now and how will we ensure patient access to these medicines (Bo Kara)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-manufacturing-challenges-now-and-how-will-we-ensure-patient-access-these-medicines-bo-kara_en.pdf"},
    {"id":"13929","name":"Declaration of interests: Xavier Kurz","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-16T10:30:00Z","last_updated_date":"2022-07-01T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-xavier-kurz_en.pdf"},
    {"id":"13932","name":"Work plan for the Pharmacovigilance Inspectors Working Group for 2015","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2015-05-04T13:37:00Z","last_updated_date":"2015-05-04T13:37:00Z","reference_number":"EMA/INS/PhV/574749/2014","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-pharmacovigilance-inspectors-working-group-2015_en.pdf"},
    {"id":"13934","name":"Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-28T02:00:00Z","last_updated_date":"2006-06-28T02:00:00Z","reference_number":"EMEA/CHMP/EWP/147013/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-role-pharmacokinetics-development-medicinal-products-paediatric-population_en.pdf"},
    {"id":"13936","name":"Oxatomide: List of nationally authorised medicinal products - PSUSA/00002233/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T13:00:00Z","last_updated_date":"2017-10-03T13:00:00Z","reference_number":"EMA/653118/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxatomide-list-nationally-authorised-medicinal-products-psusa00002233201701_en.pdf"},
    {"id":"13938","name":"Presentation - Challenges in evaluating relative effectiveness (Mira Pavlovic) - S6.1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-evaluating-relative-effectiveness-mira-pavlovic-s61_en.pdf"},
    {"id":"13939","name":"Committee for medicinal products for human use, summary of positive opinion for Rivastigmine Hexal","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/582930/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-rivastigmine-hexal_en.pdf"},
    {"id":"13940","name":"Questions and answers on the referral for Myderison tablets containing tolperisone hydrochloride 50 and 150 mg","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-10-23T02:08:21Z","last_updated_date":"2011-06-16T02:08:21Z","reference_number":"EMEA/CHMP/675340/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-myderison-tablets-containing-tolperisone-hydrochloride-50-and-150-mg_sv.pdf"}},
    {"id":"13941","name":"Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) 25 February 2014 joint meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"EMA/155728/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-25-february-2014-joint-meeting_en.pdf"},
    {"id":"13943","name":"Hydroxyethyl starch Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2013-03-04T11:00:00Z","reference_number":"EMA/126737/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-31-referral-annex-i_en.pdf"},
    {"id":"13945","name":"Bismuth subcitrate potassium / metronidazole / tetracycline: List of nationally authorised medicinal products - PSUSA/00010199/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-10-18T14:01:12Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/bismuth-subcitrate-potassium-metronidazole-tetracycline-list-nationally-authorised-medicinal-products-psusa00010199201505_en.pdf"},
    {"id":"13946","name":"EU/3/05/313: Public summary of positive opinion for orphan designation of autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene for the treatment of severe combined immunodeficienc...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T00:00:00Z","last_updated_date":"2015-03-11T01:00:00Z","reference_number":"EMEA/COMP/247430/2005 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305313-public-summary-positive-opinion-orphan-designation-autologous-cd34-cells-transfected-retroviral-vector-containing-adenosine-deaminase-gene-treatment-severe-combined-immunodeficienc_en.pdf"},
    {"id":"13947","name":"Presentation - Guidance on user safety evaluation for pharmaceutical veterinary medicinal products – development of existing and future guidance (Nicholas Jarrett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-user-safety-evaluation-pharmaceutical-veterinary-medicinal-products-development-existing-and-future-guidance-nicholas-jarrett_en.pdf"},
    {"id":"13949","name":"Mandate of the Working Group on Active Substance Master File Procedures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-18T18:51:00Z","last_updated_date":"2022-04-07T10:51:00Z","reference_number":"EMA/37869/2022 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-working-group-active-substance-master-file-procedures_en.pdf"},
    {"id":"13955","name":"EU/3/12/952: Public summary of opinion on orphan designation: Nimorazole maleate for the treatment of squamous cell carcinoma of the head and neck in patients undergoing radiotherapy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2012-03-01T01:00:00Z","reference_number":"EMA/COMP/41124/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312952-public-summary-opinion-orphan-designation-nimorazole-maleate-treatment-squamous-cell-carcinoma-head-and-neck-patients-undergoing-radiotherapy_en.pdf"},
    {"id":"13956","name":"Opinion following an Article 35  referral for Injectable veterinary medicinal products containing ivermectin that are indicated for use in cattle at dose of 200 ug ivermectin per kg bodyweight: International 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    {"id":"13957","name":"Deltamethrin (Extension to fin fish): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"EMEA/MRL/731/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/deltamethrin-extension-fin-fish-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13958","name":"Overview of comments on draft assessment report on Cetraria islandica (L.) Acharius s.l., thallus - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2015-02-11T11:45:00Z","last_updated_date":"2015-02-11T11:45:00Z","reference_number":"EMA/HMPC/572698/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-draft-assessment-report-cetraria-islandica-l-acharius-sl-thallus-first-version_en.pdf"},
    {"id":"13959","name":"Presentation - Design of PK/PD Studies (Mats Karlsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-design-pkpd-studies-mats-karlsson_en.pdf"},
    {"id":"13964","name":"EU/3/04/192: Public summary of positive opinion for orphan designation of 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2013-09-17T02:00:00Z","reference_number":"EMEA/COMP/81/04 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304192-public-summary-positive-opinion-orphan-designation-3-4aminoisoindoline-1-one-1-piperidine-26-dione-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"13967","name":"Public statement on Rivastigmine Teva: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-09-27T02:00:00Z","last_updated_date":"2012-09-27T02:00:00Z","reference_number":"EMA/611488/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-rivastigmine-teva-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"13968","name":"EMA recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/165158/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-approval-new-treatment-platinum-resistant-ovarian-cancer-together-companion-diagnostic_en.pdf"},
    {"id":"13969","name":"Questions and answers on the review of ergot-derived dopamine agonists","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-06-26T02:08:21Z","last_updated_date":"2008-06-26T02:08:21Z","reference_number":"EMEA/CHMP/319054/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-ergot-derived-dopamine-agonists_sv.pdf"}},
    {"id":"13972","name":"Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (Priya Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-25T16:03:00Z","last_updated_date":"2017-07-25T16:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-european-union-eu-gvp-priya-bahri_en.pdf-1"},
    {"id":"13975","name":"VICH GL39: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances - At step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-15T01:00:00Z","last_updated_date":"2005-11-15T01:00:00Z","reference_number":"EMEA/CVMP/VICH/810/04-corrig.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl39-test-procedures-and-acceptance-criteria-new-veterinary-drug-substances-and-new-medicinal-products-chemical-substances-step-7_en.pdf"},
    {"id":"13979","name":"Overview of comments received on 'Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T14:25:00Z","last_updated_date":"2014-01-24T14:25:00Z","reference_number":"EMA/CVMP/EWP/391540/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs_en.pdf"},
    {"id":"13980","name":"Committee for medicinal products for veterinary use: Meeting of 11 to 13 May 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-05-14T14:39:21Z","last_updated_date":"2004-05-14T14:39:21Z","reference_number":"EMEA/CVMP/477/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-11-13-may-2004_en.pdf"},
    {"id":"13982","name":"Report of the expert meeting on paediatric asthma, 20 October 2010","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T17:01:00Z","last_updated_date":"2012-11-23T17:01:00Z","reference_number":"EMA/726030/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/report-expert-meeting-paediatric-asthma-20-october-2010_en.pdf"},
    {"id":"13983","name":"Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-01-29T13:00:00Z","last_updated_date":"2016-01-29T13:00:00Z","reference_number":"EMA/55653/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_en.pdf"},
    {"id":"13984","name":"Report - Workshop on identifying opportunities for ‘big data’ in medicines development and regulatory science","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-22T10:30:00Z","last_updated_date":"2017-02-22T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-identifying-opportunities-big-data-medicines-development-and-regulatory-science_en.pdf"},
    {"id":"13987","name":"Turnera diffusa: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:09:21Z","last_updated_date":"1999-08-01T02:09:21Z","reference_number":"EMEA/MRL/678/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/turnera-diffusa-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"13988","name":"EU/3/15/1528: Public summary of opinion on orphan designation: Synthetic double-stranded RNA oligonucleotide specific to hydroxyacid oxidase 1 gene for the treatment of primary hyperoxaluria type 1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T02:00:00Z","last_updated_date":"2015-08-18T02:00:00Z","reference_number":"EMA/COMP/430728/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151528-public-summary-opinion-orphan-designation-synthetic-double-stranded-rna-oligonucleotide-specific-hydroxyacid-oxidase-1-gene-treatment-primary-hyperoxaluria-type-1_en.pdf"},
    {"id":"13989","name":"CHMP post-authorisation summary of positive opinion for Kinzalmono","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/CHMP/261191/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kinzalmono_en.pdf"},
    {"id":"13990","name":"Willow bark: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/97861/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/willow-bark-summary-public_en.pdf"},
    {"id":"13992","name":"Ambroxol and bromhexine Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ambroxol-and-bromhexine-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"13995","name":"Nadifloxacin: List of nationally authorised medicinal products    -    PSUSA/00002102/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T18:37:00Z","last_updated_date":"2017-03-09T18:43:29Z","reference_number":"EMA/150639/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/nadifloxacin-list-nationally-authorised-medicinal-products-psusa00002102201605_en.pdf"},
    {"id":"13996","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 21-24 May 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-31T12:30:00Z","last_updated_date":"2012-05-31T12:30:00Z","reference_number":"EMA/CHMP/273713/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-21-24-may-2012_en.pdf"},
    {"id":"13999","name":"CVMP summary of opinion for Easotic","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-09-19T03:09:00Z","last_updated_date":"2008-09-19T03:09:00Z","reference_number":"EMEA/CVMP/405937/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-opinion-easotic_en.pdf"},
    {"id":"14000","name":"Presentation - Review of pre-submission interactions in the centralised procedure and best practices (Michael Berntgen, Hextor Boix Perales)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-review-pre-submission-interactions-centralised-procedure-and-best-practices-michael-berntgen-hextor-boix-perales_en.pdf"},
    {"id":"14001","name":"Presentation - Impact on the product information of the additional monitoring of medicines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-product-information-additional-monitoring-medicines_en.pdf"},
    {"id":"14002","name":"Public statement on Removab: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-07-12T16:01:00Z","last_updated_date":"2017-07-12T16:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-removab-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"14021","name":"7th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-11-23T00:00:00Z","last_updated_date":"2000-11-23T00:00:00Z","reference_number":"EMEA/COMP/249/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/7th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"14022","name":"Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and human amniotic membrane mesenchymal stem cells as seeded on acellular dermal matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T13:00:00Z","last_updated_date":"2016-04-12T13:00:00Z","reference_number":"EMA/241017/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-co-culture-keratinocytes-and-human-amniotic-membrane-mesenchymal-stem-cells-seeded-acellular-dermal-matrix_en.pdf"},
    {"id":"14023","name":"EU/3/13/1215: Public summary of opinion on orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-22T01:00:00Z","last_updated_date":"2022-06-14T01:00:00Z","reference_number":"EMA/COMP/699781/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131215-public-summary-opinion-orphan-designation-4r5r-1-4-4-33-dibutyl-7-dimethylamino-2345-tetrahydro-4-hydroxy-11-dioxido-1-benzothiepin-5-ylphenoxymethylphenylmethyl-4-aza-1-azoniabi_en.pdf"},
    {"id":"14026","name":"Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"14028","name":"Agenda - PRAC draft agenda of meeting 6-9 January 2015","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-01-06T20:00:00Z","last_updated_date":"2015-01-06T20:00:00Z","reference_number":"EMA/PRAC/9223/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-6-9-january-2015_en.pdf"},
    {"id":"14030","name":"Overview of comments received on 'Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T15:25:00Z","last_updated_date":"2016-05-27T15:25:00Z","reference_number":"EMA/CHMP/BWP/337128/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-process-validation-manufacture-biotechnology-derived-active-substances-and-data-be-provided-regulatory-submission_en.pdf"},
    {"id":"14032","name":"EudraVigilance technical support plan for national competent authorities in the EEA","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2017-09-22T16:22:00Z","reference_number":"EMA/288788/2017 v 1.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-technical-support-plan-national-competent-authorities-eea_en.pdf"},
    {"id":"14034","name":"Presentation - Diabetes and endocrinology network (David Dunger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-diabetes-and-endocrinology-network-david-dunger_en.pdf"},
    {"id":"14036","name":"Fluticasone propionate / formoterol fumarate dihydrate: List of nationally authorised medicinal products - PSUSA/00010339/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-18T16:32:00Z","reference_number":"EMA/346216/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluticasone-propionate-formoterol-fumarate-dihydrate-list-nationally-authorised-medicinal-products-psusa00010339201507_en.pdf"},
    {"id":"14037","name":"Committee for medicinal products for human use summary of positive opinion for Biopoin","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:09:21Z","last_updated_date":"2009-07-23T02:09:21Z","reference_number":"EMEA/CHMP/468645/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-biopoin_en.pdf"},
    {"id":"14039","name":"Project description - Contribution agreement 2006/118-594 between EMEA and European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-10-05T02:09:21Z","last_updated_date":"2006-10-05T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/project-description-contribution-agreement-2006118-594-between-emea-and-european-commission_en.pdf"},
    {"id":"14040","name":"Fibrinogen Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T18:00:00Z","last_updated_date":"2013-04-02T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fibrinogen-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fibrinogen-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fibrinogen-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fibrinogen-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fibrinogen-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fibrinogen-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fibrinogen-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fibrinogen-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fibrinogen-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fibrinogen-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fibrinogen-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fibrinogen-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fibrinogen-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fibrinogen-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fibrinogen-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fibrinogen-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fibrinogen-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fibrinogen-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fibrinogen-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fibrinogen-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fibrinogen-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fibrinogen-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"14041","name":"Presentation - World Organisation for Animal Health (OIE): List of Antimicrobial Agents of Veterinary Importance and OIE Standards and Activities (Franà§ois Diaz, Nadà¨ge Leboucq)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-world-organisation-animal-health-oie-list-antimicrobial-agents-veterinary-importance-and-oie-standards-and-activities-franassois-diaz-nadage-leboucq_en.pdf"},
    {"id":"14042","name":"COMP report to the Commission in relation to Article 10 of Regulation 141/2000 on orphan medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-07-25T02:00:00Z","last_updated_date":"2005-07-25T02:00:00Z","reference_number":"EMEA/35218/2005 Final","document_url":"https://www.ema.europa.eu/en/documents/report/comp-report-commission-relation-article-10-regulation-1412000-orphan-medicinal-products_en.pdf"},
    {"id":"14043","name":"Agenda - Fourth industry stakeholder platform - operation of European Union pharmacovigilance legislation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T16:00:00Z","last_updated_date":"2015-06-25T16:00:00Z","reference_number":"EMA/402820/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fourth-industry-stakeholder-platform-operation-european-union-pharmacovigilance-legislation_en.pdf"},
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    {"id":"14051","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Amsterdam)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T12:57:00Z","last_updated_date":"2017-06-15T16:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-amsterdam_en.pdf"},
    {"id":"14053","name":"EU/3/13/1225: Public summary of opinion on orphan designation: Lonafarnib for the treatment of hepatitis delta virus infection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/COMP/18107/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131225-public-summary-opinion-orphan-designation-lonafarnib-treatment-hepatitis-delta-virus-infection_en.pdf"},
    {"id":"14054","name":"European Commission request for an update of the 2013 advice on the impact on public health and animal health of the use of antibiotics (colistin) in animals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-request-update-2013-advice-impact-public-health-and-animal-health-use-antibiotics-colistin-animals_en.pdf"},
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    {"id":"14057","name":"Agenda – Registries Initiative – Cystic Fibrosis Workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"EMA/648897/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-registries-initiative-cystic-fibrosis-workshop_en.pdf"},
    {"id":"14060","name":"Presentation - FDA orphan products grants program overview (Erica K McNeilly)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-orphan-products-grants-program-overview-erica-k-mcneilly_en.pdf"},
    {"id":"14062","name":"Public statement on Nespo (darbepoetin alfa): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-12-12T00:09:21Z","last_updated_date":"2008-12-12T00:09:21Z","reference_number":"EMEA/674212/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-nespo-darbepoetin-alfa-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"14064","name":"Annual report of the European Medicines Agency 2011","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-06T18:11:02Z","last_updated_date":"2012-06-06T18:11:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2011_en.pdf"},
    {"id":"14066","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 3 June 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T02:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"EMA/136044/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-3-june-2014_en.pdf"},
    {"id":"14068","name":"EU/3/03/185: Public summary  of positive opinion for orphan designation of tacrolimus hydrate for the treatment of vernal keratoconjunctivitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-04-26T02:00:00Z","last_updated_date":"2010-10-14T02:00:00Z","reference_number":"EMEA/COMP/1610/03 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303185-public-summary-positive-opinion-orphan-designation-tacrolimus-hydrate-treatment-vernal-keratoconjunctivitis_en.pdf"},
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    {"id":"14115","name":"Superseded assessment report on Curcuma longa L., rhizoma - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-02-04T01:00:00Z","last_updated_date":"2010-02-04T01:00:00Z","reference_number":"EMEA/HMPC/456848/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-curcuma-longa-l-rhizoma-first-version_en.pdf"},
    {"id":"14116","name":"European Medicines Agency to review third- and fourth-generation combined oral contraceptives","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T17:00:00Z","last_updated_date":"2013-01-28T17:00:00Z","reference_number":"EMA/20410/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-review-third-and-fourth-generation-combined-oral-contraceptives_en.pdf"},
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    {"id":"14123","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course (Bucharest)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-12-12T12:14:00Z","last_updated_date":"2017-12-12T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-2br3-format-hands-training-course-bucharest_en.pdf"},
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    {"id":"14129","name":"EMEA workshop on homeopathic medicinal products concludes to strengthen harmonisation, but accept different national traditions","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-11-28T00:09:21Z","last_updated_date":"2006-11-28T00:09:21Z","reference_number":"EMEA/460146/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-workshop-homeopathic-medicinal-products-concludes-strengthen-harmonisation-accept-different-national-traditions_en.pdf"},
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    {"id":"14143","name":"EU/3/14/1267: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against transthyretin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-06-04T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"EMA/COMP/160178/2014  Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141267-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-transthyretin-mrna-and-covalently-linked-ligand-containing-three-n_en.pdf"},
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    {"id":"14147","name":"Committee for veterinary medicinal products: Meeting of 10 to 12 December 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-12-13T12:39:21Z","last_updated_date":"2002-12-13T12:39:21Z","reference_number":"EMEA/CVMP/1222/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-10-12-december-2002_en.pdf"},
    {"id":"14148","name":"Ajmaline: List of nationally authorised medicinal products - PSUSA/00000072/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-04-18T16:07:00Z","last_updated_date":"2017-04-18T16:10:15Z","reference_number":"EMA/242228/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ajmaline-list-nationally-authorised-medicinal-products-psusa00000072201608_en.pdf"},
    {"id":"14149","name":"European Medicines Agency’s interaction with industry stakeholders - Annual report 2015","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T16:00:00Z","last_updated_date":"2016-06-17T16:00:00Z","reference_number":"EMA/48651/2016","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencys-interaction-industry-stakeholders-annual-report-2015_en.pdf"},
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    {"id":"14154","name":"Ursodeoxycholic acid : List of nationally authorised medicinal products - PSUSA/00003084/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T12:37:00Z","last_updated_date":"2017-09-06T12:38:59Z","reference_number":"EMA/578638/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ursodeoxycholic-acid-list-nationally-authorised-medicinal-products-psusa00003084201611_en.pdf"},
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    {"id":"14163","name":"Collaboration between COMP and CHMP: Patrick Salmon","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/collaboration-between-comp-and-chmp-patrick-salmon_en.pdf"},
    {"id":"14165","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-01-05T10:00:00Z","last_updated_date":"2017-01-05T10:00:00Z","reference_number":"EMA/CAT/863030/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-december-2016_en.pdf"},
    {"id":"14166","name":"Presentation - The European Union paediatric regulation in 5 minutes (Paolo Tomasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-union-paediatric-regulation-5-minutes-paolo-tomasi_en.pdf"},
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    {"id":"14169","name":"Annual report of the European Agency for Evaluation of Medicinal Products 2000","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2000-12-20T00:09:21Z","last_updated_date":"2000-12-20T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_es.pdf","da":"https://www.ema.europa.eu/da/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_da.pdf","de":"https://www.ema.europa.eu/de/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_de.pdf","el":"https://www.ema.europa.eu/el/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_fr.pdf","it":"https://www.ema.europa.eu/it/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2000_sv.pdf"}},
    {"id":"14170","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Timetable for the procedure","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T17:00:00Z","last_updated_date":"2013-03-15T12:51:00Z","reference_number":"EMA/PRAC/69142/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-timetable-procedure_en.pdf"},
    {"id":"14172","name":"CHMP summary of positive opinion for Aripiprazole Pharmathen","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/CHMP/227409/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aripiprazole-pharmathen_en.pdf"},
    {"id":"14173","name":"European Medicines Agency gives second positive opinion for a paediatric-use marketing authorisation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T13:00:00Z","last_updated_date":"2014-02-21T13:00:00Z","reference_number":"EMA/99224/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-second-positive-opinion-paediatric-use-marketing-authorisation_en.pdf"},
    {"id":"14175","name":"Draft assessment report on Cichorium intybus L., radix","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2012-06-15T13:00:00Z","last_updated_date":"2012-06-15T13:00:00Z","reference_number":"EMA/HMPC/113041/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-cichorium-intybus-l-radix_en.pdf"},
    {"id":"14176","name":"EU influenza pandemic process map","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-08-21T02:09:21Z","last_updated_date":"2006-08-21T02:09:21Z","reference_number":"EMEA/214301/2006 Annex I","document_url":"https://www.ema.europa.eu/en/documents/other/eu-influenza-pandemic-process-map_en.pdf"},
    {"id":"14177","name":"Opinion of the HMPC on a European Union herbal monograph on Peumus boldus, Molina, folium","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2017-01-12T10:48:00Z","last_updated_date":"2017-01-12T10:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-peumus-boldus-molina-folium_en.pdf"},
    {"id":"14179","name":"EU/3/16/1703: Public summary of opinion on orphan designation: Setmelanotide for the treatment of pro-opiomelanocortin deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/446373/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161703-public-summary-opinion-orphan-designation-setmelanotide-treatment-pro-opiomelanocortin-deficiency_en.pdf"},
    {"id":"14180","name":"Opinion following an Article 33 referral for Enro-k 10% oral solution International Non-Proprietary Name (INN): Enrofloxacin: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-05-06T01:59:00Z","last_updated_date":"2009-05-06T01:59:00Z","reference_number":"EMEA/214378/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-33-referral-enro-k-10-oral-solution-international-non-proprietary-name-inn-enrofloxacin-background-information_sv.pdf"}},
    {"id":"14181","name":"EU/3/05/288: Public summary of positive opinion for orphan designation of 4-[3-(methylsulfonyl)phenyl]-1-propylpiperidine x HC1 for the treatment of Huntington's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-04T02:00:00Z","last_updated_date":"2013-06-19T12:30:00Z","reference_number":"EMEA/COMP/167453/2005 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305288-public-summary-positive-opinion-orphan-designation-4-3-methylsulfonylphenyl-1-propylpiperidine-x-hc1-treatment-huntingtons-disease_en.pdf"},
    {"id":"14184","name":"CHMP statistics: July 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-july-2016_en.pdf"},
    {"id":"14186","name":"Committee for medicinal products for human use  summary of positive opinion  for Zypadhera","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-09-25T02:00:00Z","last_updated_date":"2008-09-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-zypadhera_en.pdf"},
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    {"id":"14188","name":"EU/3/11/860: Public summary of opinion on orphan designation: Adeno-associated viral vector containing the human NADH-dehydrogenase-4 gene for the treatment of Leber's hereditary optic neuropathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2013-10-07T18:00:00Z","reference_number":"EMA/COMP/154900/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311860-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-nadh-dehydrogenase-4-gene-treatment-lebers-hereditary-optic-neuropathy_en.pdf"},
    {"id":"14193","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - June 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-06-30T02:00:00Z","last_updated_date":"2007-06-30T02:00:00Z","reference_number":"EMEA/292674/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-june-2007_en.pdf"},
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    {"id":"14195","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 16-18 February 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-02-19T15:00:00Z","last_updated_date":"2016-02-19T15:00:00Z","reference_number":"EMA/CVMP/82395/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-february-2016_en.pdf"},
    {"id":"14197","name":"Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-09T15:56:00Z","last_updated_date":"2018-04-09T16:01:00Z","reference_number":"EMA/214871/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/nitrous-oxide-nitrous-oxide-oxygen-list-nationally-authorised-medicinal-products-psusa00010572201706_en.pdf"},
    {"id":"14199","name":"Certification Procedure - Elisa Pedone","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/certification-procedure-elisa-pedone_en.pdf"},
    {"id":"14201","name":"Overview of comments received on ‘Draft guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use’ (EMA/CHMP/BPWP/29205/2005 Rev. 2)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-09-29T12:00:01Z","last_updated_date":"2016-09-29T12:00:01Z","reference_number":"EMA/CHMP/BPWP/379212/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-core-smpc-human-anti-d-immunoglobulin-intramuscular-use-emachmpbpwp292052005-rev-2_en.pdf"},
    {"id":"14202","name":"Presentation - Active substances from starting materials to Active Substance Master Files (ASMFs) (Ruben Pita)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-active-substances-starting-materials-active-substance-master-files-asmfs-ruben-pita_en.pdf"},
    {"id":"14205","name":"Report - European Medicines Agency roundtable with small and medium-sized enterprise (SME) stakeholder organisations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T17:38:24Z","last_updated_date":"2011-12-21T17:38:24Z","reference_number":"EMA/810583/2011","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-medicines-agency-roundtable-small-and-medium-sized-enterprise-sme-stakeholder-organisations_en.pdf"},
    {"id":"14206","name":"EU/3/04/208: Public summary of positive opinion for orphan designation of acetylsalicylic acid for the treatment of polycythemia vera","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-12-06T01:00:00Z","last_updated_date":"2004-12-06T01:00:00Z","reference_number":"EMEA/COMP/311/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304208-public-summary-positive-opinion-orphan-designation-acetylsalicylic-acid-treatment-polycythemia-vera_en.pdf"},
    {"id":"14207","name":"Pharmaceutics International Inc. Article-31 referral – Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pharmaceutics-international-inc-article-31-referral-notification_en.pdf"},
    {"id":"14208","name":"Avinew Article-33 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-05T02:00:00Z","last_updated_date":"2014-08-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/avinew-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/avinew-article-33-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/avinew-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/avinew-article-33-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/avinew-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/avinew-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/avinew-article-33-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/avinew-article-33-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/avinew-article-33-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/avinew-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/avinew-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"14210","name":"Annex 09 Confidentiality Statement - Procurement Procedure EMA/2012/09/IF","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-09-confidentiality-statement-procurement-procedure-ema201209if_en.pdf"},
    {"id":"14212","name":"Supply shortages of Cerezyme and Fabrazyme - priority access for patients most in need of treatment recommended","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/389995/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/supply-shortages-cerezyme-and-fabrazyme-priority-access-patients-most-need-treatment-recommended_en.pdf"},
    {"id":"14216","name":"Opinions on safety variations, CHMP meeting 19-22 September 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/768869/2011","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-chmp-meeting-19-22-september-2011_en.pdf"},
    {"id":"14217","name":"Annual report of the European Medicines Agency 2007","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2008-05-13T02:00:00Z","last_updated_date":"2008-05-13T02:00:00Z","reference_number":"EMEA/MB/17464/2008","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2007_en.pdf"},
    {"id":"14219","name":"Presentation - Healthcare Professionals' Working Party (HCPWP) vis-a-vis the European Medicines Agency’s structure and activities: Roles and responsibilities of the HCPWP members (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T17:00:00Z","last_updated_date":"2013-07-12T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthcare-professionals-working-party-hcpwp-vis-vis-european-medicines-agencys-structure-and-activities-roles-and-responsibilities-hcpwp-members-ivana-silva_en.pdf"},
    {"id":"14220","name":"CHMP summary of positive opinion for Obizur","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/CHMP/471356/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-obizur_en.pdf"},
    {"id":"14222","name":"Committee for Proprietary Medicinal Products (CPMP) 17th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-06-20T02:00:00Z","last_updated_date":"1996-06-20T02:00:00Z","reference_number":"CPMP/513/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-17th-plenary-meeting_en.pdf"},
    {"id":"14223","name":"Latanoprost (except for products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001832/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-18T12:00:00Z","last_updated_date":"2017-01-18T12:00:06Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/latanoprost-except-products-paediatric-indication-list-nationally-authorised-medicinal-products-psusa00001832201604_en.pdf"},
    {"id":"14224","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M8 on the electronic common technical document (eCTD) – questions and answers","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T16:00:00Z","last_updated_date":"2013-08-22T16:00:00Z","reference_number":"EMA/CHMP/ICH/820/2003","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-m8-electronic-common-technical-document-ectd-questions-and-answers_en.pdf"},
    {"id":"14228","name":"Lederfoline - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-08-14T02:08:21Z","last_updated_date":"2003-08-14T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lederfoline-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"14229","name":"Idarubicin : List of nationally authorised medicinal products - PSUSA/00001720/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T11:47:00Z","last_updated_date":"2017-09-08T11:48:43Z","reference_number":"EMA/593214/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/idarubicin-list-nationally-authorised-medicinal-products-psusa00001720201611_en.pdf"},
    {"id":"14230","name":"Presentation - Innovation in veterinary medicines in Europe including antibiotics (Erik De Ridder)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-innovation-veterinary-medicines-europe-including-antibiotics-erik-de-ridder_en.pdf"},
    {"id":"14232","name":"Presentation - Policy on Conflicts of Interests: What it means in practice for you","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-07T01:00:00Z","last_updated_date":"2011-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-policy-conflicts-interests-what-it-means-practice-you_en.pdf"},
    {"id":"14234","name":"Public statement on Olansek (olanzapine): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2003-06-12T02:09:21Z","last_updated_date":"2003-06-12T02:09:21Z","reference_number":"EMEA/15115/03","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-olansek-olanzapine-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"14236","name":"Minutes of the Healthcare Professionals' Organisations Working Group meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2011-12-19T01:00:00Z","last_updated_date":"2011-12-19T01:00:00Z","reference_number":"EMA/873439/2011","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-healthcare-professionals-organisations-working-group-meeting_en.pdf"},
    {"id":"14237","name":"Sixth EMEA/FEDESA Joint Info Day at the European Agency in London","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-04-21T02:00:00Z","last_updated_date":"1999-04-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/sixth-emeafedesa-joint-info-day-european-agency-london_en.pdf"},
    {"id":"14238","name":"List of references supporting the assessment of Sisymbrium officinale (L.) Scop., herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-10-30T01:00:00Z","last_updated_date":"2014-10-30T01:00:00Z","reference_number":"EMA/HMPC/280195/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"14239","name":"Opinion of the CVMP on the establishment of maximum residue limits: Virginiamycin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-09-09T18:15:00Z","last_updated_date":"2015-09-09T18:15:00Z","reference_number":"EMA/CVMP/643808/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-virginiamycin_en.pdf"},
    {"id":"14240","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel DURA","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2015-07-10T02:09:21Z","reference_number":"EMEA/CHMP/379512/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-dura_en.pdf"},
    {"id":"14244","name":"Committee for Advanced Therapies (CAT): November 2009 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-11-24T00:09:21Z","last_updated_date":"2009-11-24T00:09:21Z","reference_number":"EMEA/CAT/756774/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-november-2009-meeting-monthly-report_en.pdf"},
    {"id":"14247","name":"Presentation - Proposals to European Medicines Agency from European Federation of Pharmaceutical Industries and Associations (EFPIA) (Julie Holtzople, Anne Cutting)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposals-european-medicines-agency-european-federation-pharmaceutical-industries-and-associations-efpia-julie-holtzople-anne-cutting_en.pdf"},
    {"id":"14249","name":"Withdrawal assessment report for Tyverb","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-03-16T01:00:00Z","reference_number":"EMA/CHMP/145195/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tyverb_en.pdf"},
    {"id":"14250","name":"Committee for medicinal products for veterinary use: Meeting of 10-12 February 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-13T00:09:21Z","last_updated_date":"2009-02-13T00:09:21Z","reference_number":"EMEA/CVMP/56807/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-10-12-february-2009_en.pdf"},
    {"id":"14251","name":"Artemether / lumefantrin (dispersible tablet): List of nationally authorised medicinal products - PSUSA/00009060/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-14T02:00:00Z","last_updated_date":"2016-10-17T19:47:24Z","reference_number":"EMA/413583/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/artemether-lumefantrin-dispersible-tablet-list-nationally-authorised-medicinal-products-psusa00009060201510_en.pdf"},
    {"id":"14254","name":"Qualification opinion of low hippocampal volume (atrophy) by magnetic-resonance imaging for use in clinical trials for regulatory purpose in predementia stage of Alzheimer’s disease","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-12-09T11:44:00Z","last_updated_date":"2011-12-09T11:44:00Z","reference_number":"EMA/CHMP/SAWP/809208/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-low-hippocampal-volume-atrophy-magnetic-resonance-imaging-use-clinical-trials-regulatory-purpose-predementia-stage-alzheimers-disease_en.pdf"},
    {"id":"14257","name":"CHMP summary of positive opinion for Parsabiv","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T14:00:00Z","last_updated_date":"2016-09-16T14:00:00Z","reference_number":"EMA/CHMP/587633/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-parsabiv_en.pdf"},
    {"id":"14258","name":"Final community herbal monograph on Hamamelis virginiana L., cortex","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2019-12-04T02:00:00Z","reference_number":"EMA/HMPC/114583/2008 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-hamamelis-virginiana-l-cortex_en.pdf"},
    {"id":"14259","name":"EU/3/16/1827: Public summary of opinion on orphan designation: Trans-resveratrol for the treatment of spinocerebellar ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/15858/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161827-public-summary-opinion-orphan-designation-trans-resveratrol-treatment-spinocerebellar-ataxia_en.pdf"},
    {"id":"14260","name":"Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-07-12T12:55:00Z","last_updated_date":"2013-07-12T12:55:00Z","reference_number":"EMA/CHMP/BWP/729106/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-starting-materials-and-intermediates-collected-different-sources-manufacturing-non-recombinant-biological-medicinal-products_en.pdf"},
    {"id":"14261","name":"EU/3/11/945: Public summary of positive opinion for orphan designation: Ornithine phenylacetate for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2014-10-16T16:00:00Z","reference_number":"EMA/COMP/929338/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311945-public-summary-positive-opinion-orphan-designation-ornithine-phenylacetate-treatment-acute-liver-failure_en.pdf"},
    {"id":"14262","name":"Concept paper on the revision of the guideline for the efficacy of veterinary medicinal products (pharmaceuticals) for use in farmed aquatic species","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-10-15T02:00:00Z","last_updated_date":"2007-10-15T02:00:00Z","reference_number":"EMEA/CVMP/EWP/85954/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-efficacy-veterinary-medicinal-products-pharmaceuticals-use-farmed-aquatic-species_en.pdf"},
    {"id":"14264","name":"Questions and answers on the withdrawal of medicines containing benfluorex","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2009-12-18T01:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/811097/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-withdrawal-medicines-containing-benfluorex_sv.pdf"}},
    {"id":"14265","name":"Valproate Article-31 referral - PRAC recommends new measures to avoid valproate exposure in pregnancy","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T01:00:00Z","last_updated_date":"2018-02-09T01:00:00Z","reference_number":"EMA/67672/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-prac-recommends-new-measures-avoid-valproate-exposure-pregnancy_en.pdf"},
    {"id":"14266","name":"Presentation - Good-pharmacovigilance-practice modules I-IV: Pharmacovigilance quality assurance and control (Fergus Sweeney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practice-modules-i-iv-pharmacovigilance-quality-assurance-and-control-fergus-sweeney_en.pdf"},
    {"id":"14267","name":"Message personnel de M. Fernand Sauer, Directeur Exà©cutif de l'EMEA","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-06-28T02:00:00Z","last_updated_date":"2000-06-28T02:00:00Z","reference_number":"EMEA/D/18899/FR","document_url":"https://www.ema.europa.eu/en/documents/press-release/message-personnel-de-m-fernand-sauer-directeur-exaccutif-de-lemea_en.pdf"},
    {"id":"14268","name":"European Medicines Agency recommends conditional approval of Pixuvri (pixantrone) for relapsed or refractory aggressive non-Hodgkin’s B-cell lymphoma","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T12:57:06Z","last_updated_date":"2012-02-17T12:57:06Z","reference_number":"EMA/CHMP/121961/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-conditional-approval-pixuvri-pixantrone-relapsed-or-refractory-aggressive-non-hodgkins-b-cell-lymphoma_en.pdf"},
    {"id":"14269","name":"Indapamide: List of nationally authorised medicinal products - PSUSA/00001731/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T02:00:00Z","last_updated_date":"2016-10-17T17:46:43Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/indapamide-list-nationally-authorised-medicinal-products-psusa00001731201511_en.pdf"},
    {"id":"14270","name":"Uwe Fiedler (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/uwe-fiedler-doi_en.pdf"},
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    {"id":"14273","name":"Benzalkonium chloride: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-12-01T01:00:00Z","last_updated_date":"1997-12-01T01:00:00Z","reference_number":"EMEA/MRL/306/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/benzalkonium-chloride-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"14278","name":"Final list of references supporting the assessment of Withania somnifera (L.) Dunal, radix - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/HMPC/733313/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-withania-somnifera-l-dunal-radix-first-version_en.pdf"},
    {"id":"14279","name":"Presentation - Draft guideline on pharmaceutical development of medicines for paediatric use","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-30T01:00:00Z","last_updated_date":"2012-01-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf"},
    {"id":"14280","name":"Reflection paper on pharmacogenomic samples, testing and data handling","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-11-15T01:00:00Z","last_updated_date":"2007-11-15T01:00:00Z","reference_number":"EMEA/CHMP/PGxWP/201914/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-pharmacogenomic-samples-testing-and-data-handling_en.pdf"},
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    {"id":"14282","name":"EMA fast-tracks enzyme replacement therapy for lysosomal acid lipase deficiency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/425434/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-fast-tracks-enzyme-replacement-therapy-lysosomal-acid-lipase-deficiency_en.pdf"},
    {"id":"14283","name":"CHMP summary of positive opinion for Clopidogrel Mylan Pharma","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/455323/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-clopidogrel-mylan-pharma_en.pdf"},
    {"id":"14284","name":"Methadone Article-107i procedure - Stakeholder's submission form","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-stakeholders-submission-form_en.pdf"},
    {"id":"14285","name":"Presentation - Genomics in patients with Hispanic ancestry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-genomics-patients-hispanic-ancestry_en.pdf"},
    {"id":"14286","name":"Standard operating procedure for Product Information Quality / Quality Review of Documents pre-opinion review of product information for initial applications and annex-II applications","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2009-04-08T02:00:00Z","last_updated_date":"2010-12-15T01:00:00Z","reference_number":"SOP/EMA/0009","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-product-information-quality-quality-review-documents-pre-opinion-review-product-information-initial-applications-and-annex-ii-applications_en.pdf"},
    {"id":"14289","name":"Minutes of the 67th meeting of the Management Board: 10 June 2010","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2010-08-19T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/MB/404038/2010","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-67th-meeting-management-board-10-june-2010_sv.pdf"}},
    {"id":"14291","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 gene","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-07-31T15:16:00Z","last_updated_date":"2012-10-18T13:45:00Z","reference_number":"EMA/505392/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-lenti-d-encoding-human-abcd1-gene_en.pdf"},
    {"id":"14293","name":"Draft assessment report on Gentiana lutea L., radix – Revision 1","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/607863/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-gentiana-lutea-l-radix-revision-1_en.pdf"},
    {"id":"14294","name":"Eleventh pandemic pharmacovigilance weekly update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-02-17T00:09:21Z","last_updated_date":"2010-02-17T00:09:21Z","reference_number":"EMA/102392/2010","document_url":"https://www.ema.europa.eu/en/documents/report/eleventh-pandemic-pharmacovigilance-weekly-update_en.pdf"},
    {"id":"14295","name":"Substances related to nicotinic acid Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-13T18:00:00Z","last_updated_date":"2014-03-13T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-ii_sv.pdf"}},
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    {"id":"14298","name":"ICH: E 15: Establish definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-01T01:00:00Z","last_updated_date":"2007-11-01T01:00:00Z","reference_number":"EMEA/CHMP/ICH/437986/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-15-establish-definitions-genomic-biomarkers-pharmacogenomics-pharmacogenetics-genomic-data-and-sample-coding-categories-step-5_en.pdf"},
    {"id":"14299","name":"CHMP highlights: July 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-highlights-july-2015_en.pdf"},
    {"id":"14302","name":"List of participants - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"EMA/348113/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf"},
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    {"id":"14306","name":"CTAG1: Advice to the European Medicines Agency from the Clinical trial Advisory Group on Protecting patient confidentiality - Revised after 2nd teleconference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag1-advice-european-medicines-agency-clinical-trial-advisory-group-protecting-patient-confidentiality-revised-after-2nd-teleconference_en.pdf"},
    {"id":"14310","name":"EU/3/06/371: Public summary of positive opinion for orphan designation of\n\nheparin sodium for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/126010/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306371-public-summary-positive-opinion-orphan-designation-heparin-sodium-treatment-cystic-fibrosis_en.pdf"},
    {"id":"14316","name":"Outcome of written procedures","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-10-01T02:09:21Z","last_updated_date":"2009-10-01T02:09:21Z","reference_number":"EMEA/MB/517930/2009","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-written-procedures_en.pdf"},
    {"id":"14317","name":"Initial notices for parallel distribution - May 2015","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-06-18T13:00:00Z","last_updated_date":"2015-06-18T13:00:00Z","reference_number":"EMA/392545/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-may-2015_en.pdf"},
    {"id":"14319","name":"Presentation - Good pharmacovigilance practices (P. Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-p-bahri_en.pdf"},
    {"id":"14320","name":"EU/3/14/1424: Public summary of opinion on orphan designation: Humanised Fc engineered monoclonal antibody against CD19 for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T12:00:00Z","last_updated_date":"2015-03-06T12:00:00Z","reference_number":"EMA/COMP/793170/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141424-public-summary-opinion-orphan-designation-humanised-fc-engineered-monoclonal-antibody-against-cd19-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
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    {"id":"14323","name":"Inductos Article-20 procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-12-07T01:00:00Z","last_updated_date":"2015-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/inductos-article-20-procedure-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/inductos-article-20-procedure-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/inductos-article-20-procedure-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/inductos-article-20-procedure-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/inductos-article-20-procedure-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/inductos-article-20-procedure-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/inductos-article-20-procedure-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/inductos-article-20-procedure-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/inductos-article-20-procedure-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/inductos-article-20-procedure-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/inductos-article-20-procedure-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/inductos-article-20-procedure-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/inductos-article-20-procedure-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/inductos-article-20-procedure-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/inductos-article-20-procedure-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/inductos-article-20-procedure-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/inductos-article-20-procedure-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/inductos-article-20-procedure-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/inductos-article-20-procedure-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/inductos-article-20-procedure-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/inductos-article-20-procedure-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/inductos-article-20-procedure-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/inductos-article-20-procedure-annex-i_sv.pdf"}},
    {"id":"14326","name":"Presentation - Session 2 summary: designs and methods (Jose Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-summary-designs-and-methods-jose-pinheiro_en.pdf"},
    {"id":"14328","name":"Draft reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-01-10T01:00:00Z","last_updated_date":"2008-01-10T01:00:00Z","reference_number":"EMEA/HMPC/253629/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-markers-used-quantitative-and-qualitative-analysis-herbal-medicinal-products-and-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"14329","name":"Ofloxacin (topical use): List of nationally authorised medicinal products - PSUSA/00002204/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-10-18T12:49:42Z","reference_number":"EMA/62578/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ofloxacin-topical-use-list-nationally-authorised-medicinal-products-psusa00002204201504_en.pdf"},
    {"id":"14330","name":"CVMP post-authorisation summary of negative opinion for Naxcel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-09T16:30:00Z","last_updated_date":"2012-11-09T16:30:00Z","reference_number":"EMA/CVMP/283906/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-negative-opinion-naxcel_en.pdf"},
    {"id":"14332","name":"Presentation - Joint Horizon Scanning for pharmaceuticals (I. Cleemput, KCE Belgium; A.Golja, Dutch Ministry of Health)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-horizon-scanning-pharmaceuticals-i-cleemput-kce-belgium-agolja-dutch-ministry-health_en.pdf"},
    {"id":"14333","name":"White horehound - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2014-10-10T02:00:00Z","reference_number":"EMA/HMPC/446032/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/white-horehound-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/white-horehound-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/white-horehound-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/white-horehound-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/white-horehound-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/white-horehound-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/white-horehound-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/white-horehound-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/white-horehound-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/white-horehound-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/white-horehound-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/white-horehound-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/white-horehound-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/white-horehound-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/white-horehound-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/white-horehound-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/white-horehound-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/white-horehound-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/white-horehound-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/white-horehound-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/white-horehound-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/white-horehound-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/white-horehound-summary-public_sv.pdf"}},
    {"id":"14334","name":"EU/3/04/249: Public summary of positive opinion for orphan designation of recombinant histidine tagged idiotype immunoglobulin Fab fragment of clonal B-cell receptors for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-06T00:00:00Z","last_updated_date":"2011-06-01T01:00:00Z","reference_number":"EMEA/COMP/5142/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304249-public-summary-positive-opinion-orphan-designation-recombinant-histidine-tagged-idiotype-immunoglobulin-fab-fragment-clonal-b-cell-receptors-treatment-follicular-lymphoma_en.pdf"},
    {"id":"14335","name":"Tafluprost: List of nationally authorised medicinal products - PSUSA/00002843/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T11:00:00Z","last_updated_date":"2016-10-18T13:40:20Z","reference_number":"EMA/38055/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/tafluprost-list-nationally-authorised-medicinal-products-psusa00002843201504_en.pdf"},
    {"id":"14338","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (London)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T12:57:00Z","last_updated_date":"2017-06-15T12:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-london_en.pdf"},
    {"id":"14339","name":"News bulletin for small and medium-sized enterprises - Issue 30","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-01-28T16:25:00Z","last_updated_date":"2015-01-28T16:25:00Z","reference_number":"Issue 30","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-30_en.pdf"},
    {"id":"14340","name":"EU/3/07/481: Public summary of positive opinion for orphan designation of R-salbutamol sulphate for the treatment of cutaneous forms of lupus erythematosus","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2008-07-02T02:00:00Z","reference_number":"EMEA/COMP/390202/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307481-public-summary-positive-opinion-orphan-designation-r-salbutamol-sulphate-treatment-cutaneous-forms-lupus-erythematosus_en.pdf"},
    {"id":"14342","name":"CVMP summary of positive opinion for Cimalgex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2010-12-10T01:00:00Z","reference_number":"EMA/CVMP/498811/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-cimalgex_en.pdf"},
    {"id":"14345","name":"Draft assessment report on Cimicifuga racemosa (L.) Nutt., rhizome - First version","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-09-17T02:09:21Z","last_updated_date":"2009-09-17T02:09:21Z","reference_number":"EMEA/HMPC/3968/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-cimicifuga-racemosa-l-nutt-rhizome-first-version_en.pdf"},
    {"id":"14351","name":"EU/3/06/420: Public summary of positive opinion for orphan designation of temsirolimus for the treatment of mantle cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2019-08-30T14:30:00Z","reference_number":"EMEA/COMP/195543/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306420-public-summary-positive-opinion-orphan-designation-temsirolimus-treatment-mantle-cell-lymphoma_en.pdf"},
    {"id":"14352","name":"Presentation - Results from the questionnaire to PDCO members","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-11T16:00:00Z","last_updated_date":"2015-05-11T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-results-questionnaire-pdco-members_en.pdf"},
    {"id":"14355","name":"Final recommendations on 12 centrally authorised medicines manufactured at Ben Venue Laboratories","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T18:00:00Z","last_updated_date":"2012-02-22T13:40:00Z","reference_number":"EMA/106872/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/final-recommendations-12-centrally-authorised-medicines-manufactured-ben-venue-laboratories_en.pdf"},
    {"id":"14356","name":"Draft assessment report on on Agrimonia eupatoria L., herba - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/HMPC/680595/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-agrimonia-eupatoria-l-herba-first-version_en.pdf"},
    {"id":"14362","name":"EU/3/07/446: Public summary of positive opinion for orphan designation of autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA for the treatment of metachromatic leukodystro...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2015-03-11T01:00:00Z","reference_number":"EMEA/COMP/143211/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307446-public-summary-positive-opinion-orphan-designation-autologous-cd34-cells-transfected-lentiviral-vector-containing-human-arylsulfatase-cdna-treatment-metachromatic-leukodystro_en.pdf"},
    {"id":"14363","name":"Recent actions by the European Commission concerning bee health, Emma Soto, European Commission","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/recent-actions-european-commission-concerning-bee-health-emma-soto-european-commission_en.pdf"},
    {"id":"14365","name":"Questions and answers on the ‘Note for guidance of photosafety testing’","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-11T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMA/CHMP/SWP/336670/2010","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-note-guidance-photosafety-testing_en.pdf"},
    {"id":"14367","name":"European Union recommendation for the seasonal-influenza-vaccine composition for the season 2008 / 2009","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-03-19T00:09:21Z","last_updated_date":"2008-03-19T00:09:21Z","reference_number":"EMEA/CHMP/BWP/133836/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-recommendation-seasonal-influenza-vaccine-composition-season-2008-2009_en.pdf"},
    {"id":"14368","name":"Presentation - Formulations: PIPs evaluation-case studies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-formulations-pips-evaluation-case-studies_en.pdf"},
    {"id":"14373","name":"Report: Biologics Working Party, Process Analytical Technologies Group and industry","type":"report","status":"unknown","consultation_date":"","first_published_date":"2007-07-16T02:00:00Z","last_updated_date":"2007-07-16T02:00:00Z","reference_number":"EMEA/CHMP/BWP/185370/2007","document_url":"https://www.ema.europa.eu/en/documents/report/report-biologics-working-party-process-analytical-technologies-group-and-industry_en.pdf"},
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    {"id":"14375","name":"EU/3/10/749: Public summary of positive opinion for Recombinant human anti-interferon gamma monoclonal antibody for the treatment of haemophagocytic lymphohistiocytosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMA/COMP/164768/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310749-public-summary-positive-opinion-recombinant-human-anti-interferon-gamma-monoclonal-antibody-treatment-haemophagocytic-lymphohistiocytosis_en.pdf"},
    {"id":"14377","name":"First paediatric medicine to treat rare hormonal disorder","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-12-15T01:00:00Z","last_updated_date":"2017-12-15T01:00:00Z","reference_number":"EMA/822961/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-paediatric-medicine-treat-rare-hormonal-disorder_en.pdf"},
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    {"id":"14379","name":"Use of Fluoroquinolones and Development of Resistance - Pascal Sanders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/use-fluoroquinolones-and-development-resistance-pascal-sanders_en.pdf"},
    {"id":"14380","name":"Presentation - Lifecycle of a new medicinal product (N. Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lifecycle-new-medicinal-product-n-bere_en.pdf"},
    {"id":"14384","name":"Presentation - Endpoints in a treatment trial in neuromyelitis optica: Clinician’s view (Anu Jacob)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-endpoints-treatment-trial-neuromyelitis-optica-clinicians-view-anu-jacob_en.pdf"},
    {"id":"14385","name":"Committee for Medicinal Products for Veterinary Use: Meeting of 8-10 December 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-11T01:00:00Z","last_updated_date":"2009-12-11T01:00:00Z","reference_number":"EMA/CVMP/772078/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-8-10-december-2009_en.pdf"},
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    {"id":"14387","name":"Inventory of EU PV & PE research centres in ENCePP - Minutes of working group 4","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/462010/2008","document_url":"https://www.ema.europa.eu/en/documents/minutes/inventory-eu-pv-pe-research-centres-encepp-minutes-working-group-4_en.pdf"},
    {"id":"14389","name":"Presentation - Horizon Scanning for pharmaceuticals (M.Berntgen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-horizon-scanning-pharmaceuticals-mberntgen-ema_en.pdf"},
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    {"id":"14396","name":"Corlentor Article-20 procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2015-02-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/corlentor-article-20-procedure-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/corlentor-article-20-procedure-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/corlentor-article-20-procedure-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/corlentor-article-20-procedure-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/corlentor-article-20-procedure-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/corlentor-article-20-procedure-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/corlentor-article-20-procedure-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/corlentor-article-20-procedure-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/corlentor-article-20-procedure-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/corlentor-article-20-procedure-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/corlentor-article-20-procedure-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/corlentor-article-20-procedure-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/corlentor-article-20-procedure-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/corlentor-article-20-procedure-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/corlentor-article-20-procedure-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/corlentor-article-20-procedure-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/corlentor-article-20-procedure-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/corlentor-article-20-procedure-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/corlentor-article-20-procedure-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/corlentor-article-20-procedure-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/corlentor-article-20-procedure-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/corlentor-article-20-procedure-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/corlentor-article-20-procedure-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/corlentor-article-20-procedure-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/corlentor-article-20-procedure-annex-iii_no.pdf"}},
    {"id":"14399","name":"Opinion following an Article 29(2) referral for Lansoprazol-ratiopharm 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-02-22T00:08:21Z","last_updated_date":"2006-02-22T00:08:21Z","reference_number":"EMEA/CHMP/373061/2005","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-292-referral-lansoprazol-ratiopharm-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sv.pdf"}},
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    {"id":"14401","name":"Final European Union herbal monograph on Species diureticae","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/HMPC/224755/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-species-diureticae_en.pdf"},
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    {"id":"14404","name":"Questions and answers on the suspension of the marketing authorisations for Octagam (human normal immunoglobulin 5% and 10%)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/588737/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-suspension-marketing-authorisations-octagam-human-normal-immunoglobulin-5-and-10_sv.pdf"}},
    {"id":"14405","name":"Evidence of harm from off-label or unlicensed medicines in children","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-10-01T02:00:00Z","last_updated_date":"2004-10-01T02:00:00Z","reference_number":"EMEA/126327/2004","document_url":"https://www.ema.europa.eu/en/documents/other/evidence-harm-label-or-unlicensed-medicines-children_en.pdf"},
    {"id":"14410","name":"Meeting highlights from the Paediatric Committee: 26 - 28 September  2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-10-01T02:00:00Z","last_updated_date":"2007-10-01T02:00:00Z","reference_number":"EMEA/440694/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-26-28-september-2007_en.pdf"},
    {"id":"14412","name":"Presentation - Extrapolation in inflammatory bowel disease (Richard Veselà½)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-inflammatory-bowel-disease-richard-vesela-12_en.pdf"},
    {"id":"14417","name":"EU/3/09/622: Public summary of positive opinion for orphan designation of N-(5-tert-butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt for the t...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-08T02:00:00Z","last_updated_date":"2009-04-08T02:00:00Z","reference_number":"EMEA/COMP/26165/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309622-public-summary-positive-opinion-orphan-designation-n-5-tert-butylisoxazol-3-yl-n-4-7-2-morpholin-4-ylethoxy-imidazo21-b13benzothiazol-2-ylphenylurea-di-hydrochloride-salt-t_en.pdf"},
    {"id":"14422","name":"Product information recommendations and proposals for action - Lesley Greene","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-12-03T01:00:00Z","last_updated_date":"2004-12-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/product-information-recommendations-and-proposals-action-lesley-greene_en.pdf"},
    {"id":"14425","name":"Marketing authorisation status - product template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-05-15T12:35:00Z","last_updated_date":"2017-05-15T12:35:00Z","reference_number":"EMA/217698/2017","document_url":"https://www.ema.europa.eu/en/documents/template-form/marketing-authorisation-status-product-template_en.doc"},
    {"id":"14427","name":"Withdrawal assessment report for Mersarex","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-01-04T01:00:00Z","last_updated_date":"2010-01-04T01:00:00Z","reference_number":"EMA/CHMP/697798/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-mersarex_en.pdf"},
    {"id":"14430","name":"EU/3/15/1597: Public summary of opinion on orphan designation: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytet...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2016-02-03T01:00:00Z","reference_number":"EMA/COMP/790054/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151597-public-summary-opinion-orphan-designation-sodium-2r3s5r-5-4-amino-2-oxo-135-triazin-12h-yl-2-hydroxymethyltetrahydrofuran-3-yl-2r3s5r-5-2-amino-6-oxo-1h-purin-96h-yl-3-hydroxytet_en.pdf"},
    {"id":"14431","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Arzerra (ofatumumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"EMA/847130/2016","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-arzerra-ofatumumab_sv.pdf"}},
    {"id":"14432","name":"Annex II - List of trimetazidine containing medicinal products in the European Union","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2013-11-27T11:30:00Z","last_updated_date":"2017-05-31T12:45:00Z","reference_number":"EMA/701561/2013 Corr.4","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-ii-list-trimetazidine-containing-medicinal-products-european-union_en.pdf"},
    {"id":"14434","name":"Dexpanthenol: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-09-01T02:00:00Z","last_updated_date":"2001-09-01T02:00:00Z","reference_number":"EMEA/MRL/799/01","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dexpanthenol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14435","name":"Overview of comments received on 'qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for the use of cerebrospinal-fluid amyloid beta 1-42 and t-tau and / or positron-emission-tomography amyloid...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-04-04T19:00:00Z","last_updated_date":"2012-04-04T19:00:00Z","reference_number":"EMA/922/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-qualification-opinion-alzheimers-disease-novel-methodologies-biomarkers-use-cerebrospinal-fluid-amyloid-beta-1-42-and-t-tau-and-or-positron-emission-tomography-amyloid_en.pdf"},
    {"id":"14437","name":"CHMP summary of positive opinion for Rolufta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/CHMP/39488/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rolufta_en.pdf"},
    {"id":"14439","name":"Quatresin: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-06-01T02:00:00Z","last_updated_date":"1996-06-01T02:00:00Z","reference_number":"EMEA/MRL/097/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/quatresin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14444","name":"ICT service desk EMA/2013/09/ICT - Annex C - Bespoke applications in use at EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-28T02:00:00Z","last_updated_date":"2013-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ict-service-desk-ema201309ict-annex-c-bespoke-applications-use-ema_en.pdf"},
    {"id":"14445","name":"7th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1995-11-16T12:09:21Z","last_updated_date":"1995-11-16T12:09:21Z","reference_number":"EMEA/CVMP/151/95","document_url":"https://www.ema.europa.eu/en/documents/press-release/7th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14446","name":"Draft assessment report on Levisticum officinale Koch, radix","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2012-05-03T15:41:00Z","last_updated_date":"2012-05-03T15:41:00Z","reference_number":"EMA/HMPC/524623/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-levisticum-officinale-koch-radix_en.pdf"},
    {"id":"14447","name":"Sisapronil (bovine and caprine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-12-10T10:23:00Z","last_updated_date":"2015-12-10T10:23:00Z","reference_number":"EMA/CVMP/262442/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sisapronil-bovine-and-caprine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"14449","name":"EU/3/13/1199: Public summary of opinion on orphan designation: Sorafenib tosylate for the treatment of follicular thyroid cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-12-02T01:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/COMP/637636/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131199-public-summary-opinion-orphan-designation-sorafenib-tosylate-treatment-follicular-thyroid-cancer_en.pdf"},
    {"id":"14452","name":"Opinions on annual reassessments, 5-year renewals adopted at the CHMP meeting of 14-17 November 2011","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-11-24T09:32:00Z","last_updated_date":"2011-11-24T09:32:00Z","reference_number":"EMA/CHMP/877157/2011","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-reassessments-5-year-renewals-adopted-chmp-meeting-14-17-november-2011_en.pdf"},
    {"id":"14453","name":"Ikorel and Dancor Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/238211/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/ikorel-and-dancor-article-30-referral-assessment-report_en.pdf"},
    {"id":"14455","name":"Micro Therapeutic Research Article-31 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"EMA/420215/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"14457","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations: General principles to address the risk of inadvertent germline integration of gene th...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-11-01T01:00:00Z","last_updated_date":"2006-11-01T01:00:00Z","reference_number":"CHMP/ICH/469991/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-considerations-general-principles-address-risk-inadvertent-germline-integration-gene-th_en.pdf"},
    {"id":"14461","name":"Public statement on Dutrebis: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-04-27T16:06:00Z","last_updated_date":"2017-04-27T16:06:00Z","reference_number":"EMA/193882/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-dutrebis-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"14462","name":"EU/3/14/1324: Public summary of opinion on orphan designation: 2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide for the treatment of small cell lung cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/457059/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141324-public-summary-opinion-orphan-designation-2-2-methyl-5-nitro-1h-imidazol-1-ylethylsulfamide-treatment-small-cell-lung-cancer_en.pdf"},
    {"id":"14464","name":"Presentation - Challenges encountered in clinical trials in CF: patient perspective (Emma Lake)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-encountered-clinical-trials-cf-patient-perspective-emma-lake_en.pdf"},
    {"id":"14466","name":"CHMP post-authorisation summary of positive opinion for Tysabri","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/181854/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tysabri_en.pdf"},
    {"id":"14467","name":"Metamizole Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T02:00:00Z","last_updated_date":"2018-06-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-notification_en.pdf"},
    {"id":"14468","name":"Agenda - Programme  - European Medicines Agency workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T17:15:00Z","last_updated_date":"2013-10-07T17:15:00Z","reference_number":"EMA/263897/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-european-medicines-agency-workshop-clinical-investigation-new-medicines-treatment-multiple-sclerosis_en.pdf"},
    {"id":"14469","name":"EU/3/08/563: Public summary of positive opinion for orphan designation of recombinant derivative of C3 transferase for the treatment of traumatic spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMEA/COMP/449959/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308563-public-summary-positive-opinion-orphan-designation-recombinant-derivative-c3-transferase-treatment-traumatic-spinal-cord-injury_en.pdf"},
    {"id":"14470","name":"Presentation - The role of the pharmaceutical industry, Sophie Banzet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-pharmaceutical-industry-sophie-banzet_en.pdf"},
    {"id":"14474","name":"Lanthanum: List of nationally authorised medicinal products - PSUSA/00003175/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-19T18:20:00Z","last_updated_date":"2018-01-19T18:20:00Z","reference_number":"EMA/789577/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/lanthanum-list-nationally-authorised-medicinal-products-psusa00003175201703_en.pdf"},
    {"id":"14475","name":"HMPC positive opinion on Community herbal monograph on Chamaemelum nobile (L.) All., flos","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T17:20:00Z","last_updated_date":"2012-01-20T17:20:00Z","reference_number":"EMA/HMPC/888905/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/hmpc-positive-opinion-community-herbal-monograph-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"14476","name":"Draft list of references for assessment of: Valerianae radix and Lupuli flos Valerian officinalis L. and Humulus lupulus L. (valerian root and hop strobiles)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2009-05-14T02:09:21Z","reference_number":"EMEA/HMPC/216362/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-valerianae-radix-and-lupuli-flos-valerian-officinalis-l-and-humulus-lupulus-l-valerian-root-and-hop-strobiles_en.pdf"},
    {"id":"14479","name":"Presentation - Support to paediatric medicines development (Rocio Fernandez Fresquet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-support-paediatric-medicines-development-rocio-fernandez-fresquet_en.pdf"},
    {"id":"14480","name":"CHMP post-authorisation summary of positive opinion for Victoza","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T01:00:00Z","last_updated_date":"2014-03-21T01:00:00Z","reference_number":"EMA/CHMP/164151/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-victoza_en.pdf-0"},
    {"id":"14481","name":"Opinion of the CVMP on the establishment of maximum residue limits: Methylprednisolone","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-03-22T01:00:00Z","last_updated_date":"2012-03-22T01:00:00Z","reference_number":"EMA/CVMP/822069/2010-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-methylprednisolone_en.pdf"},
    {"id":"14482","name":"Diethylene glycol monoethyl ether (Extension to all ruminants): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-09-01T02:00:00Z","last_updated_date":"2005-09-01T02:00:00Z","reference_number":"EMEA/CVMP/244224/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diethylene-glycol-monoethyl-ether-extension-all-ruminants-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14485","name":"Presentation - Norwegian Medicines Agency: Quality aspects in IMP developments (Tone Agasà¸ster)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-norwegian-medicines-agency-quality-aspects-imp-developments-tone-agasaster_en.pdf"},
    {"id":"14486","name":"Presentation - Looking towards 2020 – Our strategy for public engagement (Melanie Carr, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-looking-towards-2020-our-strategy-public-engagement-melanie-carr-ema_en.pdf"},
    {"id":"14487","name":"Benefit-risk methodology project: Work package 3 report: Field tests","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T17:46:45Z","last_updated_date":"2011-09-15T17:46:45Z","reference_number":"EMA/718294/2011","document_url":"https://www.ema.europa.eu/en/documents/report/benefit-risk-methodology-project-work-package-3-report-field-tests_en.pdf"},
    {"id":"14488","name":"Committee for veterinary medicinal products: Meeting of 9 to 10 December 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-12-12T12:39:21Z","last_updated_date":"2003-12-12T12:39:21Z","reference_number":"EMEA/CVMP/1129/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-9-10-december-2003_en.pdf"},
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    {"id":"14490","name":"EU/3/10/802: Public summary of opinion on orphan designation\n\n2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2011-11-11T01:00:00Z","reference_number":"EMA/606370/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310802-public-summary-opinion-orphan-designation-2-2-chlorophenyl-4-3-dimethylaminophenyl-5-methyl-1h-pyrazolo43-cpyridine-362h5h-dione-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
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    {"id":"14497","name":"Presentation - Gene therapy case study: Adenosine deaminase severe combined immunodeficiency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gene-therapy-case-study-adenosine-deaminase-severe-combined-immunodeficiency_en.pdf"},
    {"id":"14499","name":"Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-13T10:55:00Z","last_updated_date":"2017-06-13T10:57:00Z","reference_number":"EMA/371228/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-topical-use-list-nationally-authorised-medicinal-products-psusa00010376201610_en.pdf"},
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    {"id":"14506","name":"Committee for medicinal products for veterinary use: Meeting of 4 to 6 October 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-10-07T14:09:21Z","last_updated_date":"2005-10-07T14:09:21Z","reference_number":"EMEA/CVMP/312958/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-4-6-october-2005_en.pdf"},
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    {"id":"14508","name":"Human medicines highlights - September 2011","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T15:33:00Z","last_updated_date":"2011-10-06T15:33:00Z","reference_number":"Issue 32","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-september-2011_en.pdf"},
    {"id":"14509","name":"EMA-EU MSs-FDA initiative on inspections for Generic Applications: Terms of engagement and procedures for participating authorities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-18T15:15:00Z","last_updated_date":"2013-12-18T15:15:00Z","reference_number":"EMA/INS/GCP/644751/2012","document_url":"https://www.ema.europa.eu/en/documents/other/ema-eu-mss-fda-initiative-inspections-generic-applications-terms-engagement-and-procedures-participating-authorities_en.pdf"},
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    {"id":"14512","name":"Polyethylene glycol stearates and polyethylene glycol 15 hydroxystearate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2003-06-01T02:00:00Z","last_updated_date":"2003-06-01T02:00:00Z","reference_number":"EMEA/MRL/392/98-FINAL-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/polyethylene-glycol-stearates-and-polyethylene-glycol-15-hydroxystearate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"14515","name":"Crestor - Article 29 paediatrics referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-01T02:00:00Z","last_updated_date":"2014-08-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/crestor-article-29-paediatrics-referral-assessment-report_en.pdf"},
    {"id":"14518","name":"Fighting the Parmaceutical Crime and Counterfeit Medicines - Roy Vancauwenberghe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/fighting-parmaceutical-crime-and-counterfeit-medicines-roy-vancauwenberghe_en.pdf"},
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    {"id":"14522","name":"Committee for medicinal products for veterinary use post-authorisation summary of opinion: Rabigen SAG2","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-03-14T01:09:21Z","last_updated_date":"2008-03-14T01:09:21Z","reference_number":"EMEA/CVMP/124204/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/committee-medicinal-products-veterinary-use-post-authorisation-summary-opinion-rabigen-sag2_en.pdf"},
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    {"id":"14535","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: September 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T19:15:00Z","last_updated_date":"2017-10-23T19:15:00Z","reference_number":"EMA/516191/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-september-2017_en.pdf"},
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    {"id":"14540","name":"EU/3/14/1380: Public summary of opinion on orphan designation: Ataluren for the treatment of mucopolysaccharidosis type I","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2018-02-22T01:00:00Z","reference_number":"EMA/COMP/638269/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141380-public-summary-opinion-orphan-designation-ataluren-treatment-mucopolysaccharidosis-type-i_en.pdf"},
    {"id":"14541","name":"Hydroxyethyl starch Article-107i referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMA/697706/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-review-started_en.pdf"},
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    {"id":"14543","name":"CHMP summary of opinion for Qtern","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/271065/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-qtern_en.pdf"},
    {"id":"14544","name":"Janssen-Cilag International NV withdraws its marketing authorisation application for Comfyde (carisbamate)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-20T01:00:00Z","last_updated_date":"2010-01-20T01:00:00Z","reference_number":"EMA/32401/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/janssen-cilag-international-nv-withdraws-its-marketing-authorisation-application-comfyde-carisbamate_en.pdf"},
    {"id":"14548","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2015 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T16:32:00Z","last_updated_date":"2015-06-26T16:32:00Z","reference_number":"EMA/CAT/428422/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-june-2015-meeting_en.pdf"},
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    {"id":"14571","name":"Welcome and introduction - Dr Fritis Lekkerkerker","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-01T02:00:00Z","last_updated_date":"2003-05-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/welcome-and-introduction-dr-fritis-lekkerkerker_en.pdf"},
    {"id":"14572","name":"Background review for sodium laurilsulfate used as an excipient: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report","type":"report","status":"Draft","consultation_date":"","first_published_date":"2015-08-04T02:00:00Z","last_updated_date":"2015-08-04T02:00:00Z","reference_number":"EMA/CHMP/351898/2014","document_url":"https://www.ema.europa.eu/en/documents/report/background-review-sodium-laurilsulfate-used-excipient-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-draft-report_en.pdf"},
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    {"id":"14583","name":"Draft assessment report on Paeonia lactiflora Pall. and Paeonia veitchii Lynch, radix (Paeoniae radix rubra)","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-02-16T01:00:00Z","last_updated_date":"2016-02-16T01:00:00Z","reference_number":"EMA/HHMP/762953/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-paeonia-lactiflora-pall-and-paeonia-veitchii-lynch-radix-paeoniae-radix-rubra_en.pdf"},
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    {"id":"14596","name":"List of references supporting the assessment report on: Avenae herba and Avenae fructus Avena sativa  L. (oat herb and oat fruit)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/260098/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-report-avenae-herba-and-avenae-fructus-avena-sativa-l-oat-herb-and-oat-fruit_en.pdf"},
    {"id":"14597","name":"Applying for European Union marketing authorisation for medicinal products for human use","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2015-05-18T18:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/applying-european-union-marketing-authorisation-medicinal-products-human-use_en.pdf"},
    {"id":"14599","name":"First medicine for spinal muscular atrophy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/250453/2017  ","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-medicine-spinal-muscular-atrophy_en.pdf"},
    {"id":"14600","name":"Assessment report for Baxter dialysis solutions (3 sites)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"EMA/404194/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-baxter-dialysis-solutions-3-sites_en.pdf"},
    {"id":"14602","name":"EU/3/04/217: Public summary of positive opinion for orphan designation of sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl hosphatidylglycerol and palmitic acid for the treatment of respiratory distress synd...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/COMP/370/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304217-public-summary-positive-opinion-orphan-designation-sinapultide-dipalmitoylphosphatidylcholine-palmitoyl-oleoyl-hosphatidylglycerol-and-palmitic-acid-treatment-respiratory-distress-synd_en.pdf"},
    {"id":"14605","name":"EU/3/17/1895: Public summary of opinion on orphan designation: Retinol for the prevention of retinopathy of prematurity","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-15T16:00:00Z","last_updated_date":"2017-08-15T16:00:00Z","reference_number":"EMA/402226/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171895-public-summary-opinion-orphan-designation-retinol-prevention-retinopathy-prematurity_en.pdf"},
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    {"id":"14611","name":"Overview of comments received on 'Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration' (EMA/44410/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-06-30T19:00:00Z","last_updated_date":"2017-06-30T19:00:00Z","reference_number":"EMA/752905/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-gaucher-disease-strategic-collaborative-approach-european-medicines-agency-and-food-and-drug-administration-ema444102014_en.pdf"},
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    {"id":"14619","name":"Delapril: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information, and timetable for the implementation - PSUSA/00000946/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-06T13:00:00Z","last_updated_date":"2016-10-17T20:25:27Z","reference_number":"EMA/734289/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/delapril-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000946201501_en.pdf"},
    {"id":"14620","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - February 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-02-28T00:00:00Z","last_updated_date":"2009-02-28T00:00:00Z","reference_number":"EMEA/131690/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-february-2009_en.pdf"},
    {"id":"14622","name":"Committee for Medicinal Products for Human Use (CHMP) - December 2009 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-01-07T01:00:00Z","last_updated_date":"2010-01-13T00:00:00Z","reference_number":"EMA/CHMP/834035/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-december-2009-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"14624","name":"Public statement on Quixidar (fondaparinux sodium): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-05-16T02:00:00Z","last_updated_date":"2008-05-16T02:00:00Z","reference_number":"EMEA/245310/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-quixidar-fondaparinux-sodium-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"14626","name":"Public summary of opinion on orphan designation: Tariquidar for the treatment of P-gp positive breast cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-09-06T02:00:00Z","last_updated_date":"2012-09-06T02:00:00Z","reference_number":"EMA/COMP/444415/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-tariquidar-treatment-p-gp-positive-breast-cancer_en.pdf"},
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    {"id":"14638","name":"Action plan on activities proposed by CAT interested parties focus group on non-clinical development of advanced-therapy medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-18T13:15:00Z","last_updated_date":"2012-12-18T13:15:00Z","reference_number":"EMA/CAT/654949/2012","document_url":"https://www.ema.europa.eu/en/documents/other/action-plan-activities-proposed-cat-interested-parties-focus-group-non-clinical-development-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"14640","name":"Exclusion criteria declaration form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T12:00:00Z","last_updated_date":"2019-02-25T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/exclusion-criteria-declaration-form_en.docx"},
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    {"id":"14642","name":"Thiocolchicoside: List of nationally authorised medicinal products-PSUSA/00002927/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T12:35:00Z","last_updated_date":"2016-10-19T12:44:34Z","reference_number":"EMA/345339/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/thiocolchicoside-list-nationally-authorised-medicinal-products-psusa00002927201507_en.pdf"},
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    {"id":"14648","name":"European database networking models - Miriam C.J.M. Sturkenboom","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-database-networking-models-miriam-cjm-sturkenboom_en.pdf"},
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    {"id":"14657","name":"17th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1997-01-16T13:30:00Z","last_updated_date":"1997-01-16T13:30:00Z","reference_number":"EMEA/CVMP/018/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/17th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14660","name":"EU/3/15/1452: Public summary of positive opinion for orphan designation of tideglusib for the treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/123657/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151452-public-summary-positive-opinion-orphan-designation-tideglusib-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"14661","name":"Agenda - CAT agenda of the 23-25 May 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-05-25T14:00:00Z","last_updated_date":"2018-05-25T14:00:00Z","reference_number":"EMA/CAT/352923/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-23-25-may-2018-meeting_en.pdf"},
    {"id":"14663","name":"2008 Public status report on the implementation of the european risk\n\nmanagement strategy","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-03-17T00:00:00Z","last_updated_date":"2009-03-17T00:00:00Z","reference_number":"EMEA/43556/2009","document_url":"https://www.ema.europa.eu/en/documents/report/2008-public-status-report-implementation-european-risk-management-strategy_en.pdf"},
    {"id":"14664","name":"Withdrawal letter : NovoNorm/Prandin","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:00:00Z","last_updated_date":"2006-10-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-novonormprandin_en.pdf"},
    {"id":"14665","name":"Questions and answers on veterinary medicinal products containing colistin in combination with other antimicrobial substances to be administered orally","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-08-05T02:00:00Z","last_updated_date":"2016-08-05T02:00:00Z","reference_number":"EMA/461505/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-colistin-combination-other-antimicrobial-substances-be-administered-orally_sv.pdf"}},
    {"id":"14666","name":"Questions and answers on final recommendations on Caelyx and Ceplene manufactured at Ben Venue Laboratories","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T11:00:00Z","last_updated_date":"2012-03-16T11:00:00Z","reference_number":"EMA/178766/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-final-recommendations-caelyx-and-ceplene-manufactured-ben-venue-laboratories_en.pdf"},
    {"id":"14668","name":"Draft list of references supporting the assessment of Hypericum perforatum L., herba - Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2018-03-08T01:00:00Z","last_updated_date":"2018-03-08T01:00:00Z","reference_number":"EMA/HMPC/45511/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-hypericum-perforatum-l-herba-revision-1_en.pdf"},
    {"id":"14671","name":"Supporting regulatory science outside the EU - The Article 58 procedure","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2015-05-18T18:17:00Z","last_updated_date":"2015-05-18T18:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/supporting-regulatory-science-outside-eu-article-58-procedure_en.pdf"},
    {"id":"14674","name":"Ten years of sampling and testing of centrally authorised products: 1998-2007","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/INS/S&T/386434/2008","document_url":"https://www.ema.europa.eu/en/documents/other/ten-years-sampling-and-testing-centrally-authorised-products-1998-2007_en.pdf"},
    {"id":"14675","name":"Report - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T11:40:00Z","last_updated_date":"2017-10-27T11:40:00Z","reference_number":"EMA/664332/2017","document_url":"https://www.ema.europa.eu/en/documents/report/report-industry-stakeholder-meeting-brexit-and-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"14678","name":"Opinion of the CVMP on the establishment of maximum residue limits: Isoeugenol","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CVMP/518785/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-isoeugenol_en.pdf"},
    {"id":"14679","name":"Guidance for usage of application form related to Article 16 of the Staff Regulations","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-06-12T12:00:00Z","last_updated_date":"2022-06-15T15:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/guidance-usage-application-form-related-article-16-staff-regulations_en.pdf"},
    {"id":"14680","name":"Presentation - Leveraging prior knowledge in guiding paediatric drug development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-leveraging-prior-knowledge-guiding-paediatric-drug-development_en.pdf"},
    {"id":"14681","name":"Presentation - European antibiotic awareness day: National perspective - UK and antibiotic guardian - Session 3 (Diane Ashiru-Oredope)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-antibiotic-awareness-day-national-perspective-uk-and-antibiotic-guardian-session-3-diane-ashiru-oredope_en.pdf"},
    {"id":"14685","name":"CHMP post-authorisation summary of positive opinion for Exforge HCT","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/CHMP/388293/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-exforge-hct_en.pdf"},
    {"id":"14686","name":"Draft community herbal monograph on Salvia officinalis L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-01-14T01:00:00Z","last_updated_date":"2009-01-14T01:00:00Z","reference_number":"EMEA/HMPC/331653/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-salvia-officinalis-l-folium_en.pdf"},
    {"id":"14687","name":"Carvedilol : List of nationally authorised medicinal products - PSUSA/00000575/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T12:21:00Z","last_updated_date":"2017-12-01T12:23:18Z","reference_number":"EMA/787721/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/carvedilol-list-nationally-authorised-medicinal-products-psusa00000575201704_en.pdf"},
    {"id":"14689","name":"CHMP post-authorisation summary of positive opinion for Ryzodeg","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/399756/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ryzodeg_en.pdf"},
    {"id":"14690","name":"Draft assessment report on Rubus idaeus L., folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/HMPC/44209/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-rubus-idaeus-l-folium_en.pdf"},
    {"id":"14691","name":"Presentation - Healthcare Professionals' Working Party (HCPWP): Electronic declaration of interests, Eudralink and conference services support (Malika Holleyman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T17:00:00Z","last_updated_date":"2013-07-12T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthcare-professionals-working-party-hcpwp-electronic-declaration-interests-eudralink-and-conference-services-support-malika-holleyman_en.pdf"},
    {"id":"14699","name":"EU/3/06/368: Public summary of positive opinion for orphan designation of 1-deoxygalactonojirimycin hydrochloride for the treatment of Fabry disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2014-05-08T02:00:00Z","reference_number":"EMEA/COMP/139954/2006 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306368-public-summary-positive-opinion-orphan-designation-1-deoxygalactonojirimycin-hydrochloride-treatment-fabry-disease_en.pdf"},
    {"id":"14701","name":"EU/3/15/1515: Public summary of opinion on orphan designation: Synthetic hypericin for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T02:00:00Z","last_updated_date":"2015-08-18T02:00:00Z","reference_number":"EMA/COMP/432824/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151515-public-summary-opinion-orphan-designation-synthetic-hypericin-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"14709","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation Ledaga (chlormethine) for the treatment of cutaneous T-cell lymphoma","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T15:18:00Z","last_updated_date":"2017-03-16T15:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-ledaga-chlormethine-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"14710","name":"Presentation - Detecting Safety issues: will new scientific developments strengthen public health protection?, Prof. dr. Sturkenboom","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-detecting-safety-issues-will-new-scientific-developments-strengthen-public-health-protection-prof-dr-sturkenboom_en.pdf"},
    {"id":"14711","name":"Ceftriaxone Tyrol Pharma - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-08-30T02:08:21Z","last_updated_date":"2006-08-30T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ceftriaxone-tyrol-pharma-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"14719","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 29 March - 1 April 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T14:00:00Z","last_updated_date":"2016-04-01T14:00:00Z","reference_number":"EMA/CHMP/SAWP/236499/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-29-march-1-april-2016_en.pdf"},
    {"id":"14722","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH 2B(R3) format: hands-on training course (Zagreb)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-12-12T12:14:00Z","last_updated_date":"2017-12-12T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-2br3-format-hands-training-course-zagreb_en.pdf"},
    {"id":"14723","name":"Withdrawal letter: Cerepro","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-07-16T02:00:00Z","last_updated_date":"2007-07-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-cerepro_en.pdf"},
    {"id":"14724","name":"Overview of comments received on reflection paper on the reasons and timelines for revision of final Community herbal monographs and Community list entries (EMEA/HMPC/326440/2008)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/370642/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-reflection-paper-reasons-and-timelines-revision-final-community-herbal-monographs-and-community-list-entries-emeahmpc3264402008_en.pdf"},
    {"id":"14725","name":"Agenda - Workshop on single-arm trials (SAT) in oncology","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-06-23T17:20:00Z","reference_number":"EMA/328790/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-single-arm-trials-sat-oncology_en.pdf"},
    {"id":"14726","name":"EU/3/13/1140: Public summary of opinion on orphan designation: Expanded human allogeneic neural retinal progenitor cells extracted from neural retina for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T14:00:00Z","last_updated_date":"2013-07-11T14:00:00Z","reference_number":"EMA/COMP/307446/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131140-public-summary-opinion-orphan-designation-expanded-human-allogeneic-neural-retinal-progenitor-cells-extracted-neural-retina-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"14727","name":"CHMP protocol assistance scientific advice briefing document template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2023-06-21T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/chmp-protocol-assistance-scientific-advice-briefing-document-template_en.docx"},
    {"id":"14728","name":"Comments received from public consultation on good\n\npharmacovigilance practices (GVP): Module V – Risk management systems (Rev. 2)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T17:00:00Z","last_updated_date":"2017-03-30T17:00:00Z","reference_number":"EMA/164711/2017","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-module-v-risk-management-systems-rev-2_en.pdf"},
    {"id":"14729","name":"European Medicines Agency statement on the suspension of use of Bextra","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-04-07T02:09:21Z","last_updated_date":"2005-04-07T02:09:21Z","reference_number":"EMEA/121637/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-statement-suspension-use-bextra_en.pdf"},
    {"id":"14730","name":"Questions and answers on the withdrawal of the marketing authorisation application for Pioglitazone ratio","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-01T01:00:00Z","last_updated_date":"2012-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_en.pdf"},
    {"id":"14734","name":"EU/3/18/2010: Public summary of opinion on orphan designation: Branaplam for the treatment of spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T13:00:00Z","last_updated_date":"2018-05-17T13:00:00Z","reference_number":"EMA/197899/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182010-public-summary-opinion-orphan-designation-branaplam-treatment-spinal-muscular-atrophy_en.pdf"},
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    {"id":"14752","name":"Draft postition paper on the use of herbal medicinal products containing pulegone and menthofuran","type":"position","status":"unknown","consultation_date":"","first_published_date":"2004-05-24T02:09:21Z","last_updated_date":"2004-05-24T02:09:21Z","reference_number":"EMEA/HMPWP/52/04","document_url":"https://www.ema.europa.eu/en/documents/position/draft-postition-paper-use-herbal-medicinal-products-containing-pulegone-and-menthofuran_en.pdf"},
    {"id":"14754","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module II – Pharmacovigilance system master file","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T19:18:14Z","last_updated_date":"2012-06-25T19:18:14Z","reference_number":"EMA/428821/2012","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-module-ii-pharmacovigilance-system-master-file_en.pdf"},
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    {"id":"14791","name":"EU/3/12/1012: Public summary of opinion on orphan designation: 2S, 4R ketoconazole for treatment of Cushing's syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2012-07-24T16:00:00Z","reference_number":"EMA/COMP/357657/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121012-public-summary-opinion-orphan-designation-2s-4r-ketoconazole-treatment-cushings-syndrome_en.pdf"},
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    {"id":"14800","name":"Public statement on Ristempa: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T15:11:00Z","last_updated_date":"2018-03-07T15:11:00Z","reference_number":"EMA/792923/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ristempa-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"14801","name":"Presentation - Ph 2/3 trial for selepressin (Martin Posch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ph-23-trial-selepressin-martin-posch_en.pdf"},
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    {"id":"14805","name":"Ketoprofen (topical use only): List of nationally authorised medicinal products - PSUSA/00009205/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-17T19:03:13Z","reference_number":"EMA/345763/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketoprofen-topical-use-only-list-nationally-authorised-medicinal-products-psusa00009205201509_en.pdf"},
    {"id":"14808","name":"Presentation - Active substance master file procedure (Isabel Ugalde)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-active-substance-master-file-procedure-isabel-ugalde_en.pdf"},
    {"id":"14809","name":"Contract 2007/146-691 Instrument for Pre-accession Assistance transition assistance programme: Fourth progress report to the European Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-03-17T00:09:21Z","last_updated_date":"2009-03-17T00:09:21Z","reference_number":"EMEA/459609/2009/Corr.","document_url":"https://www.ema.europa.eu/en/documents/report/contract-2007146-691-instrument-pre-accession-assistance-transition-assistance-programme-fourth-progress-report-european-commission_en.pdf"},
    {"id":"14811","name":"Overview of comments received on 'Guideline on the role of the pathological Complete Response (pCR) as an endpoint in neoadjuvant breast cancer studies'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-10-07T16:30:00Z","last_updated_date":"2015-10-07T16:30:00Z","reference_number":"EMA/94983/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-role-pathological-complete-response-pcr-endpoint-neoadjuvant-breast-cancer-studies_en.pdf"},
    {"id":"14812","name":"Wheat starch (containing gluten) used as an excipient - Report published in support of the ‘Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use’","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2018-12-18T14:00:00Z","reference_number":"EMA/CHMP/639441/2013 Corr.2","document_url":"https://www.ema.europa.eu/en/documents/report/wheat-starch-containing-gluten-used-excipient-report-published-support-questions-and-answers-wheat-starch-containing-gluten-used-excipient-medicinal-products-human-use_en.pdf"},
    {"id":"14815","name":"50th orphan medicine receives positive opinion - List of orphan-designated authorised medicines (as of 6 November 2008)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-06T00:09:21Z","last_updated_date":"2008-11-06T00:09:21Z","reference_number":"EMEA/563575/08","document_url":"https://www.ema.europa.eu/en/documents/other/50th-orphan-medicine-receives-positive-opinion-list-orphan-designated-authorised-medicines-6-november-2008_en.pdf"},
    {"id":"14821","name":"EMEA Workshop on Neonates: Development of medicines for neonates needs multi-disciplinary cooperation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-10-25T02:09:21Z","last_updated_date":"2006-10-25T02:09:21Z","reference_number":"EMEA/416788/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-workshop-neonates-development-medicines-neonates-needs-multi-disciplinary-cooperation_en.pdf"},
    {"id":"14822","name":"Withdrawal assessment report for Theraloc","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-05-07T02:00:00Z","last_updated_date":"2009-05-07T02:00:00Z","reference_number":"EMEA/67305/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-theraloc_en.pdf"},
    {"id":"14823","name":"Presentation - Topic 5 - Clinical trial transparency - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Fergus Sweeney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-5-clinical-trial-transparency-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-fergus-sweeney_en.pdf"},
    {"id":"14825","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - March 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-03-31T02:00:00Z","last_updated_date":"2005-03-31T02:00:00Z","reference_number":"EMEA/CVMP/103137/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-march-2005_en.pdf"},
    {"id":"14827","name":"European Medicines Agency recommends two new treatment options for tuberculosis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T13:00:10Z","last_updated_date":"2013-11-22T13:00:10Z","reference_number":"EMA/717915/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-two-new-treatment-options-tuberculosis_en.pdf"},
    {"id":"14828","name":"Fifth pandemic pharmacovigilance weekly update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-01-06T01:00:00Z","last_updated_date":"2010-01-06T01:00:00Z","reference_number":"EMA/4476/2010","document_url":"https://www.ema.europa.eu/en/documents/report/fifth-pandemic-pharmacovigilance-weekly-update_en.pdf"},
    {"id":"14829","name":"Report of expert meeting on Factor VIII products and inhibitor development","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2007-02-22T00:09:21Z","last_updated_date":"2007-02-22T00:09:21Z","reference_number":"EMEA/CHMP/BPWP/123835/2006","document_url":"https://www.ema.europa.eu/en/documents/report/report-expert-meeting-factor-viii-products-and-inhibitor-development_en.pdf"},
    {"id":"14830","name":"Questions and answers relating to open tender procedure - EMA/2011/35/DIS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-08T17:20:00Z","last_updated_date":"2012-02-08T17:20:00Z","reference_number":"EMA/99021/2012","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-open-tender-procedure-ema201135dis_en.pdf"},
    {"id":"14831","name":"CHMP post-authorisation summary of positive opinion for Prezista","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2015-02-09T16:20:00Z","reference_number":"EMA/CHMP/580195/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prezista_en.pdf-0"},
    {"id":"14832","name":"CVMP summary of positive opinion for Exzolt","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-06-16T02:00:00Z","last_updated_date":"2017-06-16T02:00:00Z","reference_number":"EMA/CVMP/268590/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-exzolt_en.pdf"},
    {"id":"14833","name":"EU/3/15/1508: Public summary of opinion on orphan designation: Triheptanoin for the treatment of very long-chain acyl-CoA dehydrogenase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"EMA/COMP/345427/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151508-public-summary-opinion-orphan-designation-triheptanoin-treatment-very-long-chain-acyl-coa-dehydrogenase-deficiency_en.pdf"},
    {"id":"14838","name":"Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T10:30:00Z","last_updated_date":"2014-02-28T10:30:00Z","reference_number":"EMA/204715/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools-and-effectiveness-indicators-tracked-changes_en.pdf"},
    {"id":"14839","name":"Presentation - Lessons learnt - Melanoma: academic perspective (Paolo Ascierto) - S2.1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lessons-learnt-melanoma-academic-perspective-paolo-ascierto-s21_en.pdf"},
    {"id":"14841","name":"Presentation - The organisational and functional structure of the European Network of Paediatric Research at the European Medicines Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:50Z","last_updated_date":"2011-05-27T15:25:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-organisational-and-functional-structure-european-network-paediatric-research-european-medicines-agency_en.pdf"},
    {"id":"14842","name":"Note for guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-02-20T01:00:00Z","last_updated_date":"2003-02-20T01:00:00Z","reference_number":"CPMP/QWP/ 3309/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-use-near-infrared-spectroscopy-pharmaceutical-industry-and-data-requirements-new-submissions-and-variations_en.pdf"},
    {"id":"14843","name":"Presentation - EMA-HMA Network international initiatives on innovation (Martin Harvey Allchurch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-hma-network-international-initiatives-innovation-martin-harvey-allchurch_en.pdf"},
    {"id":"14846","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the December 2011 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-12-09T11:56:00Z","last_updated_date":"2011-12-09T11:56:00Z","reference_number":"EMA/COMP/811367/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-december-2011-meeting_en.pdf"},
    {"id":"14849","name":"Summary information on the opinion pursuant to Article 10 of Council Directive 75/319/EEC as amended, for Kà©toprofà¨ne Ethypharm LP  International Non-Proprietary Name (INN): ketoprofen: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2000-12-28T00:08:21Z","last_updated_date":"2000-12-28T00:08:21Z","reference_number":"CPMP/1988/00","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-opinion-pursuant-article-10-council-directive-75319eec-amended-kactoprofane-ethypharm-lp-international-non-proprietary-name-inn-ketoprofen-background-information_en.pdf"},
    {"id":"14851","name":"Withdrawal assessment report for Insulin Human Long Marvel","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/CHMP/70349/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-insulin-human-long-marvel_en.pdf"},
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    {"id":"14855","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - May 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-05-31T02:00:00Z","last_updated_date":"2007-05-31T02:00:00Z","reference_number":"EMEA/238705/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-may-2007_en.pdf"},
    {"id":"14856","name":"Numeta Article-107i procedure - Annex VI","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-27T15:00:00Z","last_updated_date":"2013-09-27T15:00:00Z","reference_number":"EMEA/H/A-107i/1373","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-annex-vi_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/numeta-article-107i-procedure-annex-vi_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/numeta-article-107i-procedure-annex-vi_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/numeta-article-107i-procedure-annex-vi_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/numeta-article-107i-procedure-annex-vi_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/numeta-article-107i-procedure-annex-vi_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/numeta-article-107i-procedure-annex-vi_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/numeta-article-107i-procedure-annex-vi_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/numeta-article-107i-procedure-annex-vi_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/numeta-article-107i-procedure-annex-vi_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/numeta-article-107i-procedure-annex-vi_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/numeta-article-107i-procedure-annex-vi_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/numeta-article-107i-procedure-annex-vi_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/numeta-article-107i-procedure-annex-vi_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/numeta-article-107i-procedure-annex-vi_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/numeta-article-107i-procedure-annex-vi_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/numeta-article-107i-procedure-annex-vi_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/numeta-article-107i-procedure-annex-vi_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/numeta-article-107i-procedure-annex-vi_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/numeta-article-107i-procedure-annex-vi_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/numeta-article-107i-procedure-annex-vi_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/numeta-article-107i-procedure-annex-vi_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/numeta-article-107i-procedure-annex-vi_sv.pdf"}},
    {"id":"14859","name":"Ethinylestradiol / levonorgestrel: List of nationally authorised medicinal products - PSUSA/00001309/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T01:00:00Z","last_updated_date":"2016-12-14T19:03:00Z","reference_number":"EMA/858449/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethinylestradiol-levonorgestrel-list-nationally-authorised-medicinal-products-psusa00001309201604_en.pdf"},
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    {"id":"14861","name":"Draft list of references supporting the assessment of Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-07-31T18:30:00Z","last_updated_date":"2013-07-31T18:30:00Z","reference_number":"EMA/HMPC/307783/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-eucalyptus-globulus-labill-eucalyptus-polybractea-rt-baker-andor-eucalyptus-smithii-rt-baker-aetheroleum_en.pdf"},
    {"id":"14862","name":"Amlodipine / perindopril: List of nationally authorised medicinal products - PSUSA/00000179/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-12T10:45:00Z","last_updated_date":"2017-06-12T11:05:00Z","reference_number":"EMA/369195/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-perindopril-list-nationally-authorised-medicinal-products-psusa00000179201610_en.pdf"},
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    {"id":"14866","name":"Technical specifications for service concession: meeting and training organisation (EMA/2016/43/RS)","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:30:00Z","last_updated_date":"2016-08-15T12:30:00Z","reference_number":"EMA/303267/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-service-concession-meeting-and-training-organisation-ema201643rs_en.pdf"},
    {"id":"14867","name":"EU/3/18/2016: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the treatment of follicular lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-24T12:51:00Z","last_updated_date":"2022-02-21T12:51:00Z","reference_number":"EMA/262875/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182016-public-summary-opinion-orphan-designation-autologous-cd4-and-cd8-t-cells-expressing-cd19-specific-chimeric-antigen-receptor-treatment-follicular-lymphoma_en.pdf"},
    {"id":"14868","name":"Concept paper on the development of a guideline on the quality aspects of single-dose veterinary spot-on products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T01:00:00Z","last_updated_date":"2006-12-15T01:00:00Z","reference_number":"EMEA/CVMP/QWP/434665/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-quality-aspects-single-dose-veterinary-spot-products_en.pdf"},
    {"id":"14869","name":"Presentation - Good pharmacovigilance practice module IX: Signal management","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T13:00:00Z","last_updated_date":"2012-02-29T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practice-module-ix-signal-management_en.pdf"},
    {"id":"14872","name":"Presentation - Dose finding for a β-lactam – β-lactamase inhibitor combination (Shampa Das, Astra Zeneca)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-finding-i2-lactam-i2-lactamase-inhibitor-combination-shampa-das-astra-zeneca_en.pdf"},
    {"id":"14873","name":"General principles: European Medicines Agency-Food and Drug Administration parallel scientific advice","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-22T02:00:00Z","last_updated_date":"2021-08-18T08:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/general-principles-european-medicines-agency-food-and-drug-administration-parallel-scientific-advice_en.pdf"},
    {"id":"14877","name":"Committee for Proprietary Medicinal Products (CPMP) 55th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-12-20T01:00:00Z","last_updated_date":"1999-12-20T01:00:00Z","reference_number":"CPMP/3323/99 corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-55th-plenary-meeting_en.pdf"},
    {"id":"14880","name":"Presentation - CVMP","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp_en.pdf"},
    {"id":"14881","name":"Recruitment for the European Medicines Agency: General conditions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-09-01T02:00:00Z","last_updated_date":"2010-09-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/recruitment-european-medicines-agency-general-conditions_en.pdf"},
    {"id":"14882","name":"Homeopathy Workshop at the European Medicines Agency - Aude Sapere","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/homeopathy-workshop-european-medicines-agency-aude-sapere_en.pdf"},
    {"id":"14884","name":"Presentation - How do we transform big data into knowledge to support decision making? (Thomas Senderovitz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-do-we-transform-big-data-knowledge-support-decision-making-thomas-senderovitz_en.pdf"},
    {"id":"14886","name":"Presentation - Discussion on specific indications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:47Z","last_updated_date":"2011-04-26T18:05:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-discussion-specific-indications_en.pdf"},
    {"id":"14892","name":"EU/3/12/994: Public summary of opinion on orphan designation: Yttrium (90Y)-DTPA-radiolabelled chimeric monoclonal antibody against frizzled homologue 10 for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:55:00Z","last_updated_date":"2012-06-18T16:55:00Z","reference_number":"EMA/COMP/203343/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312994-public-summary-opinion-orphan-designation-yttrium-90y-dtpa-radiolabelled-chimeric-monoclonal-antibody-against-frizzled-homologue-10-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"14894","name":"Committee for proprietary medicinal products July 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-07-31T02:00:00Z","last_updated_date":"2002-07-31T02:00:00Z","reference_number":"EMEA/CPMP/3473/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-july-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"14896","name":"Draft agenda - Focus group meeting on the guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-09-11T18:00:00Z","last_updated_date":"2018-09-11T18:00:00Z","reference_number":"EMA/459760/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-focus-group-meeting-guideline-assessment-risk-public-health-antimicrobial-resistance-due-use-antimicrobial-veterinary-medicinal-product-food-producing-animals_en.pdf"},
    {"id":"14898","name":"Guideline on clinical investigation of medicinal products, including depot preparations, in the treatment of schizophrenia - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-10-09T15:59:00Z","last_updated_date":"2012-10-09T15:59:00Z","reference_number":"EMA/CHMP/40072/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-including-depot-preparations-treatment-schizophrenia-revision-1_en.pdf"},
    {"id":"14899","name":"Agenda - 2009 EMEA/IFAH-Europe Info Day - 'The latest developments' in scientific review, legislation and marketing authorisation procedures - Programme","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-03-20T00:09:21Z","last_updated_date":"2009-03-20T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2009-emeaifah-europe-info-day-latest-developments-scientific-review-legislation-and-marketing-authorisation-procedures-programme_en.pdf"},
    {"id":"14901","name":"Presentation - Minimising risk: a health professional perspective (Donald RJ Singer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-minimising-risk-health-professional-perspective-donald-rj-singer_en.pdf"},
    {"id":"14902","name":"Overview of comments received on the draft 'Information in the package leaflet for aspartame'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/581993/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-information-package-leaflet-aspartame_en.pdf"},
    {"id":"14904","name":"Presentation - Young research subjects - old problems","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-young-research-subjects-old-problems_en.pdf"},
    {"id":"14906","name":"Day 80 assessment report - Generic clinical and non-clinical template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-26T00:09:21Z","last_updated_date":"2013-03-05T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-80-assessment-report-generic-clinical-and-non-clinical-template_en.doc"},
    {"id":"14908","name":"Presentation - Antimicrobial use in animals: OIE collection of data on antimicrobial agents used in animals (2015) (Gerard Moulin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T17:00:00Z","last_updated_date":"2016-03-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antimicrobial-use-animals-oie-collection-data-antimicrobial-agents-used-animals-2015-gerard-moulin_en.pdf"},
    {"id":"14909","name":"Caustinerf arsenical and Yranicid arsenical Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-06T14:00:00Z","last_updated_date":"2014-08-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/caustinerf-arsenical-and-yranicid-arsenical-article-31-referral-annex-i_sv.pdf"}},
    {"id":"14910","name":"Flupirtine-containing medicines Article-107i procedure - PRAC list of questions to be addressed by the marketing-authorisation holders","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-08T13:00:00Z","last_updated_date":"2013-03-08T13:00:00Z","reference_number":"EMA/PRAC/137417/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-prac-list-questions-be-addressed-marketing-authorisation-holders_en.pdf"},
    {"id":"14912","name":"EU/3/01/061: Public summary of positive opinion for imatinib mesilate for the treatment of malignant gastrointestinal stromal tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T01:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/COMP/10367/2003 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301061-public-summary-positive-opinion-imatinib-mesilate-treatment-malignant-gastrointestinal-stromal-tumours_en.pdf"},
    {"id":"14913","name":"Presentation - Basis for regulatory decision-making:  Objectives of paediatric development (A.El-Gazayerly, Dutch Medicines Evaluation Board)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-basis-regulatory-decision-making-objectives-paediatric-development-ael-gazayerly-dutch-medicines-evaluation-board_en.pdf"},
    {"id":"14915","name":"EU/3/13/1155: Public summary of opinion on orphan designation: Allogeneic motor-neurone progenitor cells derived from human embryonic stem cells for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-16T13:00:00Z","last_updated_date":"2013-08-16T13:00:00Z","reference_number":"EMA/COMP/413414/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131155-public-summary-opinion-orphan-designation-allogeneic-motor-neurone-progenitor-cells-derived-human-embryonic-stem-cells-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"14916","name":"European Union regulatory workshop in ophthalmology - Expression of interest form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2011-07-04T02:00:00Z","last_updated_date":"2011-07-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/european-union-regulatory-workshop-ophthalmology-expression-interest-form_en.pdf"},
    {"id":"14918","name":"Risk Management Plans - Stella Blackburn","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/risk-management-plans-stella-blackburn_en.pdf"},
    {"id":"14919","name":"Presentation: What ever happened to the IMI2 proposal?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-ever-happened-imi2-proposal_en.pdf"},
    {"id":"14920","name":"Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/603417/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/factor-viii-medicines-no-clear-and-consistent-evidence-difference-risk-inhibitor-development-between-classes_en.pdf"},
    {"id":"14922","name":"European Medicines Agency's Management Board supports plan to publish agendas and minutes of all committees","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"EMA/605248/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-supports-plan-publish-agendas-and-minutes-all-committees_en.pdf"},
    {"id":"14924","name":"Guideline on plastic immediate packaging materials","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-05-19T02:00:00Z","last_updated_date":"2005-05-19T02:00:00Z","reference_number":"CPMP/QWP/4359/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-plastic-immediate-packaging-materials_en.pdf"},
    {"id":"14925","name":"Promestriene (cream and vaginal capsules): List of nationally authorised medicinal products - PSUSA/00009271/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T15:54:00Z","last_updated_date":"2017-12-20T16:03:00Z","reference_number":"EMA/844321/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/promestriene-cream-and-vaginal-capsules-list-nationally-authorised-medicinal-products-psusa00009271201703_en.pdf"},
    {"id":"14926","name":"Willow herb - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-02-10T01:00:00Z","last_updated_date":"2016-02-10T01:00:00Z","reference_number":"EMA/822538/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/willow-herb-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/willow-herb-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/willow-herb-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/willow-herb-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/willow-herb-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/willow-herb-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/willow-herb-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/willow-herb-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/willow-herb-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/willow-herb-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/willow-herb-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/willow-herb-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/willow-herb-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/willow-herb-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/willow-herb-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/willow-herb-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/willow-herb-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/willow-herb-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/willow-herb-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/willow-herb-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/willow-herb-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/willow-herb-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/willow-herb-summary-public_sv.pdf"}},
    {"id":"14927","name":"Presentation - The industry's views on geriatric medicines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industrys-views-geriatric-medicines_en.pdf"},
    {"id":"14933","name":"Organisational matters - CHMP meeting 18-21 February 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-28T13:45:00Z","last_updated_date":"2013-02-28T13:45:00Z","reference_number":"EMA/CHMP/109953/2013","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-18-21-february-2013_en.pdf"},
    {"id":"14934","name":"Helixate NexGen Article-20 procedure - Product information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-09T12:00:00Z","last_updated_date":"2014-04-09T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/helixate-nexgen-article-20-procedure-product-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/helixate-nexgen-article-20-procedure-product-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/helixate-nexgen-article-20-procedure-product-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/helixate-nexgen-article-20-procedure-product-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/helixate-nexgen-article-20-procedure-product-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/helixate-nexgen-article-20-procedure-product-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/helixate-nexgen-article-20-procedure-product-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/helixate-nexgen-article-20-procedure-product-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/helixate-nexgen-article-20-procedure-product-information_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/helixate-nexgen-article-20-procedure-product-information_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/helixate-nexgen-article-20-procedure-product-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/helixate-nexgen-article-20-procedure-product-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/helixate-nexgen-article-20-procedure-product-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/helixate-nexgen-article-20-procedure-product-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/helixate-nexgen-article-20-procedure-product-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/helixate-nexgen-article-20-procedure-product-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/helixate-nexgen-article-20-procedure-product-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/helixate-nexgen-article-20-procedure-product-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/helixate-nexgen-article-20-procedure-product-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/helixate-nexgen-article-20-procedure-product-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/helixate-nexgen-article-20-procedure-product-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/helixate-nexgen-article-20-procedure-product-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/helixate-nexgen-article-20-procedure-product-information_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/helixate-nexgen-article-20-procedure-product-information_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/helixate-nexgen-article-20-procedure-product-information_no.pdf"}},
    {"id":"14935","name":"CHMP post-authorisation summary of positive opinion for Taxotere","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-taxotere_en.pdf"},
    {"id":"14936","name":"Committee for Medicinal Products for Human Use (CHMP) - March 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-03-29T02:00:00Z","last_updated_date":"2007-03-29T02:00:00Z","reference_number":"EMEA/144134/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-march-2007-plenary-meeting-monthly-report_en.pdf"},
    {"id":"14938","name":"CVMP reflection paper on the risks that should be considered prior to the use of unauthorised vaccines in emergency situations","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-09-28T12:00:00Z","last_updated_date":"2016-09-28T12:00:00Z","reference_number":"EMA/CVMP/IWP/49593/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/cvmp-reflection-paper-risks-should-be-considered-prior-use-unauthorised-vaccines-emergency-situations_en.pdf"},
    {"id":"14939","name":"Opinions on safety variations adopted at the Committee for Medicinal Products for Human Use meeting of 17-20 October 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-21T14:01:00Z","last_updated_date":"2011-10-21T14:01:00Z","reference_number":"EMA/CHMP/832564/2011","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-committee-medicinal-products-human-use-meeting-17-20-october-2011_en.pdf"},
    {"id":"14940","name":"CVMP summary of positive opinion for Versican Plus DHPPi/L4R","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-03-14T01:00:00Z","last_updated_date":"2014-03-14T01:00:00Z","reference_number":"EMA/CVMP/92024/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-versican-plus-dhppil4r_en.pdf"},
    {"id":"14942","name":"Clorsulon: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-10-25T02:00:00Z","last_updated_date":"1999-10-25T02:00:00Z","reference_number":"EMEA/MRL/037/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/clorsulon-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14945","name":"Technical specification - Annex 13 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"EMA/269479/2012","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-13-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"14946","name":"Electronic form for paediatric-investigation-plan application and request for waiver - (PED1) certified","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-05-28T02:00:00Z","last_updated_date":"2021-10-11T10:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/electronic-form-paediatric-investigation-plan-application-and-request-waiver-ped1-certified_en.pdf"},
    {"id":"14947","name":"EU/3/14/1418: Public summary of opinion on orphan designation: A lentiviral vector pseudotyped by the New-Jersey serotype of the vesicular stomatitis virus G protein encoding an antigen derived from the Tax, HBZ, p12I an...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/COMP/786967/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141418-public-summary-opinion-orphan-designation-lentiviral-vector-pseudotyped-new-jersey-serotype-vesicular-stomatitis-virus-g-protein-encoding-antigen-derived-tax-hbz-p12i_en.pdf"},
    {"id":"14952","name":"Ergot derivatives Article-31 referral - Dihydroergocryptine - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-i_sv.pdf"}},
    {"id":"14953","name":"Lincomycin (Extension to all food producing species): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/MRL/824/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lincomycin-extension-all-food-producing-species-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"14955","name":"EU/3/12/1023: Public summary of opinion on orphan designation: Metreleptin for the treatment of Barraquer-Simons syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-08-31T12:30:00Z","last_updated_date":"2015-05-13T12:30:00Z","reference_number":"EMA/COMP/440571/2012 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121023-public-summary-opinion-orphan-designation-metreleptin-treatment-barraquer-simons-syndrome_en.pdf"},
    {"id":"14957","name":"Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-08-03T17:00:00Z","last_updated_date":"2018-08-03T17:00:00Z","reference_number":"EMA/CHMP/800789/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ledipasvirsofosbuvir-film-coated-tablet-90-mg400-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"14958","name":"Public statement on Clopidogrel Qualimed: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-09-08T02:00:00Z","last_updated_date":"2014-09-08T02:00:00Z","reference_number":"EMA/539040/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-qualimed-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"14959","name":"E-Submission: From 2005 to 2008, A great step forward - Andrà© Lhoir","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/e-submission-2005-2008-great-step-forward-andrac-lhoir_en.pdf"},
    {"id":"14960","name":"Questions and answers on the positive opinion on the marketing authorisation for Ninlaro (ixazomib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/615008/2016 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-positive-opinion-marketing-authorisation-ninlaro-ixazomib_en.pdf"},
    {"id":"14962","name":"Superseded overview of comments received on ‘Community herbal monograph on Humulus lupulus L., flos’ - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-07-11T02:00:00Z","last_updated_date":"2014-08-07T02:00:00Z","reference_number":"EMEA/HMPC/577303/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-humulus-lupulus-l-flos-first-version_en.pdf"},
    {"id":"14965","name":"CHMP summary of positive opinion for Scenesse","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/CHMP/601448/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-scenesse_en.pdf"},
    {"id":"14966","name":"Draft revision - External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-09T01:00:00Z","last_updated_date":"2016-12-09T01:00:00Z","reference_number":"EMA/90915/2016","document_url":"https://www.ema.europa.eu/en/documents/other/draft-revision-external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use_en.pdf"},
    {"id":"14967","name":"Codeine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-07T12:55:00Z","last_updated_date":"2013-03-04T11:00:00Z","reference_number":"EMA/713187/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-i_en.pdf-0"},
    {"id":"14968","name":"Presentation - European Medicines Network Coordinating role of the Agency within the network- clarifying roles and responsibilities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-network-coordinating-role-agency-within-network-clarifying-roles-and-responsibilities_en.pdf"},
    {"id":"14970","name":"Overview of comments received on guideline on non-clinical studies required before first clinical use of gene therapy medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/65260/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-guideline-non-clinical-studies-required-first-clinical-use-gene-therapy-medicinal-products_en.pdf"},
    {"id":"14973","name":"EU/3/10/843: Public summary of opinion on orphan designation:  Allogeneic aortic endothelial cells cultured in a porcine gelatin matrix for the prevention of arteriovenous access failure in haemodialysis patients","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2017-05-17T16:00:00Z","reference_number":"EMA/COMP/831251/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310843-public-summary-opinion-orphan-designation-allogeneic-aortic-endothelial-cells-cultured-porcine-gelatin-matrix-prevention-arteriovenous-access-failure-haemodialysis-patients_en.pdf"},
    {"id":"14974","name":"Opinion following an Article 40 referral for Suvaxyn Parvo/E: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T01:59:00Z","last_updated_date":"2008-06-02T01:59:00Z","reference_number":"EMEA/532267/2007- Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-40-referral-suvaxyn-parvoe-background-information_sv.pdf"}},
    {"id":"14975","name":"Ad hoc working group on Herbal Medicinal Products: Proposal for a Note for guidance on non-clinical testing of herbal drug preparations with long-term marketing experience - Guidance to facilitate mutual recognition and ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"1998-09-17T02:00:00Z","last_updated_date":"1998-09-17T02:00:00Z","reference_number":"EMEA/HMPWP/11/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-group-herbal-medicinal-products-proposal-note-guidance-non-clinical-testing-herbal-drug-preparations-long-term-marketing-experience-guidance-facilitate-mutual-recognition-and_en.pdf"},
    {"id":"14978","name":"Questions and answers on the supply situation of Caelyx","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/254938/2013 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-supply-situation-caelyx_en.pdf"},
    {"id":"14981","name":"EU/3/08/592: Public summary of positive opinion for orphan designation of murine anti-CD22 antibody variable region fused to truncated Pseudomonas exotoxin 38 for the treatment of hairy cell leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/546613/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308592-public-summary-positive-opinion-orphan-designation-murine-anti-cd22-antibody-variable-region-fused-truncated-pseudomonas-exotoxin-38-treatment-hairy-cell-leukaemia_en.pdf"},
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    {"id":"14986","name":"Isoniazid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001789/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T02:00:00Z","last_updated_date":"2016-10-17T18:51:24Z","reference_number":"EMA/511244/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/isoniazid-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001789201411_en.pdf"},
    {"id":"14987","name":"Ad hoc working party on Herbal Medicinal Products:  Final comments on notice to applicants volume 2B part IB1 – Summary of product characteristics","type":"other","status":"unknown","consultation_date":"","first_published_date":"1998-09-17T02:00:00Z","last_updated_date":"1998-09-17T02:00:00Z","reference_number":"EMEA/HMPWP/12/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-party-herbal-medicinal-products-final-comments-notice-applicants-volume-2b-part-ib1-summary-product-characteristics_en.pdf"},
    {"id":"14989","name":"Presentation - Development of drugs in paediatric neuromyelitis optica and neuromyelitis optica spectrum disorders: Industry perspective (Josephine Glover)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-paediatric-neuromyelitis-optica-and-neuromyelitis-optica-spectrum-disorders-industry-perspective-josephine-glover_en.pdf"},
    {"id":"14991","name":"Report on second workshop of the European Paediatric Research Network (EnprEMA), 16 March 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/report-second-workshop-european-paediatric-research-network-enprema-16-march-2010_en.pdf"},
    {"id":"14992","name":"Guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-12-14T13:05:00Z","last_updated_date":"2011-12-14T13:05:00Z","reference_number":"EMA/CHMP/BWP/360642/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-warning-transmissible-agents-summary-product-characteristics-smpcs-and-package-leaflets-plasma-derived-medicinal-products_en.pdf"},
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    {"id":"14994","name":"EU/3/13/1178: Public summary of opinion on orphan designation: Pegylated recombinant anti-Pseudomonas aeruginosa PcrV Fab’ antibody for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-13T02:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMA/COMP/440852/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131178-public-summary-opinion-orphan-designation-pegylated-recombinant-anti-pseudomonas-aeruginosa-pcrv-fab-antibody-treatment-pseudomonas-aeruginosa-lung-infection-cystic-fibrosis_en.pdf"},
    {"id":"14995","name":"EU/3/18/2026: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro a...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T18:30:00Z","last_updated_date":"2018-07-23T18:30:00Z","reference_number":"EMA/275373/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182026-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-targeted-against-transthyretin-mrna-six-phosphorothioate-linkages-backbone-and-nine-2-fluoro_en.pdf"},
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    {"id":"14999","name":"Draft EMEA policy on the practical operation of access to EMEA documents","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T00:00:00Z","last_updated_date":"2008-12-18T00:00:00Z","reference_number":"EMEA/110196/2006/Final","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-emea-policy-practical-operation-access-emea-documents_en.pdf"},
    {"id":"15000","name":"Presentation - The place for treatments of associated neuropsychiatric and other symptoms (Luca Pani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-place-treatments-associated-neuropsychiatric-and-other-symptoms-luca-pani_en.pdf"},
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    {"id":"15011","name":"EMA Management Board discusses next steps after judgment of EU Civil Service Tribunal","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T01:00:00Z","last_updated_date":"2014-12-01T01:00:00Z","reference_number":"EMA/746361/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-discusses-next-steps-after-judgment-eu-civil-service-tribunal_en.pdf"},
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    {"id":"15013","name":"Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T12:35:00Z","last_updated_date":"2016-04-19T12:35:00Z","reference_number":"EMA/264500/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-bone-marrow-derived-autologous-non-hematopoietic-stem-cells_en.pdf"},
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    {"id":"15026","name":"Public statement on Avandamet: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-06-08T02:00:00Z","last_updated_date":"2016-06-08T02:00:00Z","reference_number":"EMEA/H/C/000522","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-avandamet-expiry-marketing-authorisation-european-union_en.pdf"},
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    {"id":"15030","name":"EMA working group on committees’ operational preparedness for veterinary medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-16T15:00:00Z","last_updated_date":"2017-06-16T15:00:00Z","reference_number":"EMA/300988/2017","document_url":"https://www.ema.europa.eu/en/documents/other/ema-working-group-committees-operational-preparedness-veterinary-medicines_en.pdf"},
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    {"id":"15035","name":"Finasteride: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"15038","name":"Questions and answers on generic escitalopram-containing medicines (tablets containing escitalopram oxalate, 5, 10, 15 and 20 mg)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-02-20T00:59:00Z","last_updated_date":"2010-02-20T00:59:00Z","reference_number":"EMA/89593/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-generic-escitalopram-containing-medicines-tablets-containing-escitalopram-oxalate-5-10-15-and-20-mg_en.pdf"},
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    {"id":"15079","name":"Gendux Molecular Limited withdraws its marketing authorisation application for Contusugene ladenovec Gendux","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/412751/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/gendux-molecular-limited-withdraws-its-marketing-authorisation-application-contusugene-ladenovec-gendux_en.pdf"},
    {"id":"15082","name":"Methadone Article-107i procedure - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-04T02:00:00Z","last_updated_date":"2014-08-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methadone-article-107i-procedure-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methadone-article-107i-procedure-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methadone-article-107i-procedure-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methadone-article-107i-procedure-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methadone-article-107i-procedure-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methadone-article-107i-procedure-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methadone-article-107i-procedure-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methadone-article-107i-procedure-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methadone-article-107i-procedure-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methadone-article-107i-procedure-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methadone-article-107i-procedure-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methadone-article-107i-procedure-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methadone-article-107i-procedure-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methadone-article-107i-procedure-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methadone-article-107i-procedure-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methadone-article-107i-procedure-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methadone-article-107i-procedure-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methadone-article-107i-procedure-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methadone-article-107i-procedure-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methadone-article-107i-procedure-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methadone-article-107i-procedure-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methadone-article-107i-procedure-annex-ii_sv.pdf"}},
    {"id":"15083","name":"Presentation - 4.4 A decision theoretic approach to optimize clinical trial designs for targeted therapies (Martin Posch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-44-decision-theoretic-approach-optimize-clinical-trial-designs-targeted-therapies-martin-posch_en.pdf"},
    {"id":"15084","name":"The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2017-09-26T12:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/european-network-centres-pharmacoepidemiology-and-pharmacovigilance_en.pdf"},
    {"id":"15087","name":"Presentation - Early access session (Martine Zimmermann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-access-session-martine-zimmermann_en.pdf"},
    {"id":"15088","name":"Draft list of references supporting the assessment of Crataegus spp., folium cum flore","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-10-14T02:00:00Z","last_updated_date":"2014-10-14T02:00:00Z","reference_number":"EMA/HMPC/378548/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"15089","name":"Final assessment report on Echinacea purpurea (L.) Moench, radix – Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-08-11T02:00:00Z","last_updated_date":"2017-08-11T02:00:00Z","reference_number":"EMA/HMPC/424584/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-echinacea-purpurea-l-moench-radix-revision-1_en.pdf"},
    {"id":"15091","name":"EU/3/08/572: Public summary of positive opinion for orphan designation of (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate for the treatment of chronic idiopathic myelofib...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2015-05-08T02:00:00Z","reference_number":"EMEA/COMP/488810/2008 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308572-public-summary-positive-opinion-orphan-designation-r-3-4-7h-pyrrolo23-dpyrimidin-4-yl-1h-pyrazol-1-yl-3-cyclopentylpropanenitrile-phosphate-treatment-chronic-idiopathic-myelofib_en.pdf"},
    {"id":"15092","name":"Superseded list of references supporting the assessment of Vitis vinifera L., folium - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/16634/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-vitis-vinifera-l-folium-first-version_en.pdf"},
    {"id":"15093","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Kolbam (cholic acid) for the treatment of inborn errors in primary bile acid synthesis responsive to treatment with cholic acid","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/COMP/663120/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-kolbam-cholic-acid-treatment-inborn-errors-primary-bile-acid-synthesis-responsive-treatment-cholic-acid_en.pdf"},
    {"id":"15097","name":"Public statement on Viraferon (interferon alfa-2b) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T00:09:21Z","last_updated_date":"2008-11-20T00:09:21Z","reference_number":"EMEA/567934/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-viraferon-interferon-alfa-2b-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"15098","name":"Superseded list of references supporting the assessment report on: Salviae folium and Salviae aetheroleum: Salvia officinalis L., folium and Salvia officinalis L., aetheroleum: (Sage leaf and Sage oil)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2017-07-13T02:00:00Z","reference_number":"EMA/HMPC/331645/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-salviae-folium-and-salviae-aetheroleum-salvia-officinalis-l-folium-and-salvia-officinalis-l-aetheroleum-sage-leaf-and-sage-oil_en.pdf"},
    {"id":"15099","name":"Agenda for the 89th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-09-29T16:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/MB/169330/2015 V.3","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-89th-meeting-management-board_en.pdf"},
    {"id":"15103","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Motilium and associated names International Non-Proprietary Name (INN): domperidone: Background inf...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-10-17T02:08:21Z","last_updated_date":"2002-10-17T02:08:21Z","reference_number":"EMEA/CPMP/4786/02/en/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-motilium-and-associated-names-international-non-proprietary-name-inn-domperidone-background_en.pdf"},
    {"id":"15104","name":"Opinion of the CVMP on the establishment of maximum residue limits: Tildipirosin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-10-26T19:38:55Z","last_updated_date":"2010-10-26T19:38:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-tildipirosin_en.pdf-0"},
    {"id":"15105","name":"Presentation - Interacting with industry stakeholders at the European Medicines Agency (Melanie Carr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interacting-industry-stakeholders-european-medicines-agency-melanie-carr_en.pdf"},
    {"id":"15107","name":"Numeta Article-107i procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-27T15:00:00Z","last_updated_date":"2013-09-27T15:00:00Z","reference_number":"EMEA/H/A-107i/1373","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/numeta-article-107i-procedure-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/numeta-article-107i-procedure-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/numeta-article-107i-procedure-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/numeta-article-107i-procedure-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/numeta-article-107i-procedure-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/numeta-article-107i-procedure-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/numeta-article-107i-procedure-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/numeta-article-107i-procedure-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/numeta-article-107i-procedure-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/numeta-article-107i-procedure-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/numeta-article-107i-procedure-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/numeta-article-107i-procedure-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/numeta-article-107i-procedure-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/numeta-article-107i-procedure-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/numeta-article-107i-procedure-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/numeta-article-107i-procedure-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/numeta-article-107i-procedure-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/numeta-article-107i-procedure-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/numeta-article-107i-procedure-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/numeta-article-107i-procedure-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/numeta-article-107i-procedure-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/numeta-article-107i-procedure-annex-iii_sv.pdf"}},
    {"id":"15108","name":"Public statement on Intrinsa: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-06-18T18:37:00Z","last_updated_date":"2012-07-16T18:37:00Z","reference_number":"EMA/360944/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-intrinsa-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"15109","name":"Committee for Proprietary Medicinal Products (CPMP): meeting of 18 to 20 September 2001","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-09-25T02:09:21Z","last_updated_date":"2001-09-25T02:09:21Z","reference_number":"CPMP/2973/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-meeting-18-20-september-2001_en.pdf"},
    {"id":"15111","name":"Presentation - Visualizing uncertainty among laypersons and experts (Andrea Beyer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-visualizing-uncertainty-among-laypersons-and-experts-andrea-beyer_en.pdf"},
    {"id":"15114","name":"Draft assessment report on Symphytum officinale L., radix","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-08-19T02:00:00Z","last_updated_date":"2011-08-19T02:00:00Z","reference_number":"EMA/HMPC/572844/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-symphytum-officinale-l-radix_en.pdf"},
    {"id":"15119","name":"CHMP statistics: February 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-02-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-february-2018_en.pdf"},
    {"id":"15120","name":"Presentation - EuroNeoNet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-euroneonet_en.pdf"},
    {"id":"15122","name":"Agenda - Fifth training workshop SMEs","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2010-03-04T01:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"EMA/770537/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fifth-training-workshop-smes_en.pdf"},
    {"id":"15124","name":"Minutes of the Patients' and Consumers’ Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint meeting - June 2013","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-07-18T17:00:00Z","last_updated_date":"2013-07-18T17:00:00Z","reference_number":"EMA/362080/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-meeting-june-2013_en.pdf"},
    {"id":"15129","name":"Presentation - Extrapolation plan and statistical tools - Panel discussion (Flora Musuamba, Alexander Staab)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-plan-and-statistical-tools-panel-discussion-flora-musuamba-alexander-staab_en.pdf"},
    {"id":"15130","name":"Declaration of interests: Sylvie Beausuroy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:06Z","last_updated_date":"2017-08-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-sylvie-beausuroy_en.pdf"},
    {"id":"15131","name":"CHMP post-authorisation summary of positive opinion for Dafiro","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/CHMP/397193/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dafiro_en.pdf"},
    {"id":"15132","name":"CHMP summary of positive opinion for Brineura","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/CHMP/208415/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-brineura_en.pdf"},
    {"id":"15135","name":"Presentation - NOAC future perspectives: academic perspective (Hugo ten Cate)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-noac-future-perspectives-academic-perspective-hugo-ten-cate_en.pdf"},
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    {"id":"15149","name":"European Medicines Agency update on combined contraceptives","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T09:00:00Z","last_updated_date":"2013-01-11T09:00:00Z","reference_number":"EMA/19198/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-update-combined-contraceptives_en.pdf"},
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    {"id":"15151","name":"Questions and answers on recommendation for the refusal of the marketing authorisation for Natalizumab Elan Pharma 300 mg","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/310856/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-natalizumab-elan-pharma-300-mg_en.pdf"},
    {"id":"15153","name":"COMP meeting report on the review of applications for orphan designation: January 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-01-28T12:30:00Z","last_updated_date":"2016-02-02T12:30:00Z","reference_number":"EMA/COMP/843956/2015 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-january-2016_en.pdf"},
    {"id":"15154","name":"Presentation - Age-appropriate formulations – paediatric needs","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-30T01:00:00Z","last_updated_date":"2012-01-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-age-appropriate-formulations-paediatric-needs_en.pdf"},
    {"id":"15156","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-02-05T16:02:00Z","last_updated_date":"2018-02-05T16:02:00Z","reference_number":"EMA/827608/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-december-2017_en.pdf"},
    {"id":"15158","name":"Presentation - Introduction to the work of the PDCO Formulation Working Group","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-work-pdco-formulation-working-group_en.pdf"},
    {"id":"15159","name":"Presentation - PRIME first experiences (James Kennard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prime-first-experiences-james-kennard_en.pdf"},
    {"id":"15161","name":"Orbax Article-33 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-11T02:00:00Z","last_updated_date":"2014-08-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/orbax-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/orbax-article-33-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/orbax-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/orbax-article-33-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/orbax-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/orbax-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/orbax-article-33-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/orbax-article-33-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/orbax-article-33-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/orbax-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/orbax-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"15163","name":"Committee for Medicinal Products for Human Use (CHMP) -  October 2006 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:00:00Z","last_updated_date":"2006-10-27T02:00:00Z","reference_number":"EMEA/410526/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-october-2006-plenary-meeting-monthly-report_en.pdf"},
    {"id":"15166","name":"Clarification of the role of the Office of Training Steering Group in new training initiatives within the network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-06T01:00:00Z","last_updated_date":"2012-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/clarification-role-office-training-steering-group-new-training-initiatives-within-network_en.pdf"},
    {"id":"15167","name":"Public Statement on Tritanrix HepB: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-01-07T01:00:00Z","last_updated_date":"2014-01-07T01:00:00Z","reference_number":"EMA/748663/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-tritanrix-hepb-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"15168","name":"Report on budgetary and financial management: financial year 2016","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-08-20T18:30:00Z","last_updated_date":"2018-08-20T18:30:00Z","reference_number":"EMA/875653/2016","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2016_en.pdf"},
    {"id":"15172","name":"Superseded assessment report on Echinacea purpurea (L.) Moench, radix - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-02-10T01:00:00Z","last_updated_date":"2011-02-10T01:00:00Z","reference_number":"EMA/HMPC/577786/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-echinacea-purpurea-l-moench-radix-first-version_en.pdf"},
    {"id":"15173","name":"EU/3/14/1417: Public summary of opinion on orphan designation: A lentiviral vector pseudotyped by the Indiana serotype of the vesicular stomatitis virus G protein encoding an antigen derived from the Tax, HBZ, p12I and p...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/COMP/786963/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141417-public-summary-opinion-orphan-designation-lentiviral-vector-pseudotyped-indiana-serotype-vesicular-stomatitis-virus-g-protein-encoding-antigen-derived-tax-hbz-p12i-and-p_en.pdf"},
    {"id":"15174","name":"Agenda - Training session for patients, consumers and healthcare professionals interested in European Medicines Agency activities","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-17T18:09:00Z","last_updated_date":"2017-12-13T12:15:00Z","reference_number":"EMA/662990/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-patients-consumers-and-healthcare-professionals-interested-european-medicines-agency-activities_en.pdf"},
    {"id":"15176","name":"Presentation - GMP phage production for clinical trials (Laurent Bretaudeau)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gmp-phage-production-clinical-trials-laurent-bretaudeau_en.pdf"},
    {"id":"15177","name":"Presentation - Forward (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-forward-peter-arlett_en.pdf"},
    {"id":"15178","name":"Presentation - Involving patients and healthcare professionals in regulatory decisions - MEB (Sandra Kruger-Peters)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involving-patients-and-healthcare-professionals-regulatory-decisions-meb-sandra-kruger-peters_en.pdf"},
    {"id":"15179","name":"ECDC, EFSA and EMA joint scientific opinion on a list of\n\noutcome indicators as regards surveillance of antimicrobial\n\nresistance and antimicrobial consumption in humans and\n\nfood-producing animals","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T15:00:00Z","last_updated_date":"2017-10-26T15:00:00Z","reference_number":"doi: 10.2903/j.efsa.2017.5017","document_url":"https://www.ema.europa.eu/en/documents/report/ecdc-efsa-and-ema-joint-scientific-opinion-list-outcome-indicators-regards-surveillance-antimicrobial-resistance-and-antimicrobial-consumption-humans-and-food-producing-animals_en.pdf"},
    {"id":"15181","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (Croatia)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-croatia_en.pdf"},
    {"id":"15185","name":"CHMP post-authorisation summary of positive opinion for Signifor (X-30-G)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T14:00:00Z","last_updated_date":"2017-07-21T14:00:00Z","reference_number":"EMA/CHMP/431002/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-signifor-x-30-g_en.pdf"},
    {"id":"15186","name":"Dimethyl and diethyl phthalates: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-03-27T01:00:00Z","last_updated_date":"2002-03-27T01:00:00Z","reference_number":"EMEA/MRL/049/95-CORRIGENDUM","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dimethyl-and-diethyl-phthalates-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"15187","name":"Organisational matters - CHMP meeting 22-25 February 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-03-04T15:00:00Z","last_updated_date":"2016-03-04T15:00:00Z","reference_number":"EMA/67076/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-22-25-february-2016_en.pdf"},
    {"id":"15189","name":"Superseded overview of comments received on Community herbal monograph on Trigonella foenum-graecum L., semen","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2022-08-30T02:00:00Z","last_updated_date":"2022-08-30T02:00:00Z","reference_number":"EMA/HMPC/729635/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-trigonella-foenum-graecum-l-semen_en.pdf"},
    {"id":"15190","name":"Presentation - Novel therapies: Innovation Task Force (ITF), scientific advice and new Ad Hoc group on Veterinary Novel Therapies (ADVENT) (Fia Westerholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-novel-therapies-innovation-task-force-itf-scientific-advice-and-new-ad-hoc-group-veterinary-novel-therapies-advent-fia-westerholm_en.pdf"},
    {"id":"15191","name":"Withdrawal letter: Balimek","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T01:00:00Z","last_updated_date":"2018-01-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-balimek_en.pdf"},
    {"id":"15192","name":"Overview of comments received on 'community herbal monograph on Avena sativa L., fructus' (EMEA/HMPC/368600/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/225876/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-avena-sativa-l-fructus-emeahmpc3686002007_en.pdf"},
    {"id":"15197","name":"Presentation - Case study: EURACAN clinical research (Stephane Lejeune)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-euracan-clinical-research-stephane-lejeune_en.pdf"},
    {"id":"15198","name":"Overview of comments received on draft guideline on compassionate use of medicinal products, pursuant to Article 83 of Regulation (EC) No 726/2004","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-07-23T02:00:00Z","last_updated_date":"2007-07-23T02:00:00Z","reference_number":"EMEA/333892/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-guideline-compassionate-use-medicinal-products-pursuant-article-83-regulation-ec-no-7262004_en.pdf"},
    {"id":"15199","name":"Committee for Medicinal Products for Human Use positive summary of opinion for Raloxifene Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-02-19T01:00:00Z","last_updated_date":"2010-02-19T01:00:00Z","reference_number":"EMA/CHMP/74631/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-positive-summary-opinion-raloxifene-teva_en.pdf"},
    {"id":"15200","name":"Annual report of the Pharmacovigilance Inspectors Working Group for 2014","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-12T13:17:00Z","last_updated_date":"2015-08-12T13:17:00Z","reference_number":"EMA/INS/PhV/380702/2015","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-pharmacovigilance-inspectors-working-group-2014_en.pdf"},
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    {"id":"15202","name":"eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) product export tool user manual","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T12:58:00Z","last_updated_date":"2014-05-08T12:58:00Z","reference_number":"EMA/207051/2014","document_url":"https://www.ema.europa.eu/en/documents/other/extended-eudravigilance-medicinal-product-dictionary-xevmpd-product-export-tool-user-manual_en.pdf"},
    {"id":"15204","name":"Position paper on assessment of the risk of transmission of animal spongiform encephalopathy agents by master seed materials used in the production of veterinary vaccines","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2001-02-16T01:00:00Z","last_updated_date":"2001-02-16T01:00:00Z","reference_number":"EMEA/CVMP/019/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-assessment-risk-transmission-animal-spongiform-encephalopathy-agents-master-seed-materials-used-production-veterinary-vaccines_en.pdf"},
    {"id":"15209","name":"Presentation - Experience with the review of the orphan designation in the context of extension of indication (Kristina Larsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:16:00Z","last_updated_date":"2018-06-06T17:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-review-orphan-designation-context-extension-indication-kristina-larsson_en.pdf"},
    {"id":"15210","name":"European Medicines Agency gives guidance for use of antiviral medicines in case of a novel influenza A/H1N1 pandemic","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-08T02:00:00Z","last_updated_date":"2009-05-08T02:00:00Z","reference_number":"EMEA/285148/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-guidance-use-antiviral-medicines-case-novel-influenza-ah1n1-pandemic_en.pdf"},
    {"id":"15211","name":"EU/3/16/1642: Public summary of opinion on orphan designation: Autologous dermal fibroblasts genetically modified ex vivo with a lentiviral vector containing the human COL7A1 gene for the treatment of epidermolysis bullo...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/252366/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161642-public-summary-opinion-orphan-designation-autologous-dermal-fibroblasts-genetically-modified-ex-vivo-lentiviral-vector-containing-human-col7a1-gene-treatment-epidermolysis-bullo_en.pdf"},
    {"id":"15212","name":"Presentation - Break out session 3 Proposals on how patients can be involved in networks (trial design etc) and in trials (Elizabeth Vroom, Duchene Parent Project and Juan Garcia Burgos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-break-out-session-3-proposals-how-patients-can-be-involved-networks-trial-design-etc-and-trials-elizabeth-vroom-duchene-parent-project-and-juan-garcia-burgos-ema_en.pdf"},
    {"id":"15214","name":"Note for guidance on summary of requirements for active substances In part ii of the dossier","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-01-28T01:00:00Z","last_updated_date":"1998-01-28T01:00:00Z","reference_number":"CPMP/QWP/297/97","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-summary-requirements-active-substances-part-ii-dossier_en.pdf"},
    {"id":"15215","name":"Agenda - PRAC draft agenda of meeting 6-9 January 2014","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-01-06T18:15:00Z","last_updated_date":"2014-01-06T18:15:00Z","reference_number":"EMA/PRAC/4877/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-6-9-january-2014_en.pdf"},
    {"id":"15216","name":"EU/3/16/1807: Public summary of opinion on orphan designation: Udenafil for the treatment of functional single ventricle congenital heart disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/754417/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161807-public-summary-opinion-orphan-designation-udenafil-treatment-functional-single-ventricle-congenital-heart-disease_en.pdf"},
    {"id":"15217","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-04-17T12:10:00Z","last_updated_date":"2015-04-17T12:10:00Z","reference_number":"EMA/189863/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-march-2015_en.pdf"},
    {"id":"15218","name":"Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T13:00:00Z","last_updated_date":"2021-07-09T13:00:00Z","reference_number":"EMA/796016/2012 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-medicines-which-studies-have-been-conducted-texas-based-cetero-research-facility_en.pdf"},
    {"id":"15219","name":"CHMP post-authorisation summary of positive opinion for Prezista","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/CHMP/51975/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prezista_en.pdf-1"},
    {"id":"15221","name":"Draft concept paper on selection of test materials for genotoxicity testing for traditional herbal medicinal products/ herbal medicinal products1\n\n - An annex to Guideline on the Assessment of Genotoxicity of Herbal subs...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-07-15T02:00:00Z","last_updated_date":"2008-07-15T02:00:00Z","reference_number":"EMEA/HMPC/315413/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-selection-test-materials-genotoxicity-testing-traditional-herbal-medicinal-products-herbal-medicinal-products1-annex-guideline-assessment-genotoxicity-herbal-subs_en.pdf"},
    {"id":"15222","name":"Minutes - Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"EMA/CVMP/EWP/412810/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-veterinary-focus-group-meeting-stakeholders-revision-reflection-paper-anthelmintic-resistance_en.pdf"},
    {"id":"15224","name":"Handling conflicts of interest for patients’ and consumers’ organisations (J. Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/handling-conflicts-interest-patients-and-consumers-organisations-j-garcia_en.pdf"},
    {"id":"15226","name":"2013 annual report on EudraVigilance for the European Parliament, the Council and the Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T17:29:00Z","last_updated_date":"2014-04-28T17:29:00Z","reference_number":"EMA/145085/2014","document_url":"https://www.ema.europa.eu/en/documents/report/2013-annual-report-eudravigilance-european-parliament-council-and-commission_en.pdf"},
    {"id":"15227","name":"European Medicines Agency makes recommendations on the use of\n\nantimicrobials in livestock and companion animals in relation to the risk of\n\nMRSA infection in animals","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-27T00:09:21Z","last_updated_date":"2009-03-27T00:09:21Z","reference_number":"EMEA/CVMP/176994/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-makes-recommendations-use-antimicrobials-livestock-and-companion-animals-relation-risk-mrsa-infection-animals_en.pdf"},
    {"id":"15232","name":"European Risk Management Strategy: Progress to date and next steps","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-05-11T02:09:21Z","last_updated_date":"2005-05-11T02:09:21Z","reference_number":"EMEA/136253/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-risk-management-strategy-progress-date-and-next-steps_en.pdf"},
    {"id":"15233","name":"EU/3/13/1180: Public summary of opinion on orphan designation: Apremilast for the treatment of Behà§et’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-13T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"EMA/COMP/433213/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131180-public-summary-opinion-orphan-designation-apremilast-treatment-behassets-disease_en.pdf"},
    {"id":"15234","name":"Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-30T17:00:00Z","last_updated_date":"2018-11-30T17:15:00Z","reference_number":"EMA/164014/2018 Rev. 2.0.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf"},
    {"id":"15235","name":"Agenda - Innovative Medicines Initiative WEB-RADR project: mobile technologies and social media as new tools in pharmacovigilance workshop programme","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-08-03T02:00:00Z","last_updated_date":"2016-10-17T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-innovative-medicines-initiative-web-radr-project-mobile-technologies-and-social-media-new-tools-pharmacovigilance-workshop-programme_en.pdf"},
    {"id":"15237","name":"Orlistat - Article 31 referral - Assessment report for orlistat-containing medicinal products","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-12-21T01:00:00Z","last_updated_date":"2012-12-21T01:00:00Z","reference_number":"EMA/276546/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/orlistat-article-31-referral-assessment-report-orlistat-containing-medicinal-products_en.pdf"},
    {"id":"15238","name":"European Medicines Agency recommends continued vaccination with Gardasil","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-19T01:00:00Z","last_updated_date":"2009-02-19T01:00:00Z","reference_number":"EMEA/CHMP/103339/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-continued-vaccination-gardasil_en.pdf"},
    {"id":"15239","name":"Technical specifications - Annex III - Summary checklist - Procurement procedure EMA/2014/35/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T15:00:00Z","last_updated_date":"2015-02-23T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-iii-summary-checklist-procurement-procedure-ema201435re_en.pdf"},
    {"id":"15242","name":"CHMP post-authorisation summary of positive opinion for Glivec on 19 March 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-03-20T01:00:00Z","last_updated_date":"2009-03-20T01:00:00Z","reference_number":"EMEA/CHMP/659495/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-glivec-19-march-2009_en.pdf"},
    {"id":"15243","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n20-23 July 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-07-24T02:00:00Z","last_updated_date":"2009-07-24T02:00:00Z","reference_number":"EMEA/CHMP/468553/2009 corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-20-23-july-2009_en.pdf"},
    {"id":"15244","name":"European Medicines Agency gives recommendations to deal with sterility assurance concerns for DepoCyte","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-08-24T13:15:00Z","last_updated_date":"2012-08-24T13:15:00Z","reference_number":"EMA/CHMP/555991/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-recommendations-deal-sterility-assurance-concerns-depocyte_en.pdf"},
    {"id":"15247","name":"CHMP post-authorisation summary of positive opinion for Tyverb","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-02-19T01:00:00Z","last_updated_date":"2010-02-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tyverb_en.pdf-0"},
    {"id":"15255","name":"PDCO meeting highlights 29-31 July 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/PDCO/412084/2008-Corr","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-29-31-july-2008_en.pdf"},
    {"id":"15260","name":"CHMP summary of opinion for Coagadex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-01-29T01:00:00Z","reference_number":"EMA/CHMP/15062/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-coagadex_en.pdf"},
    {"id":"15262","name":"Guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1 (Corr)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-12-17T01:00:00Z","last_updated_date":"2003-12-17T01:00:00Z","reference_number":"CPMP/QWP/ 122/02 Rev. 1 corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-stability-testing-stability-testing-existing-active-substances-and-related-finished-products-revision-1-corr_en.pdf"},
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    {"id":"15312","name":"Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-29T01:00:00Z","last_updated_date":"2016-10-18T10:40:09Z","reference_number":"EMA/716223/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/lisdexamfetamine-list-nationally-authorised-medicinal-products-psusa00010289201502_en.pdf"},
    {"id":"15315","name":"Overview of the training on electronic submission of information on medicines - new pharmacovigilance legislation (Art. 57, paragraph 2,\n\n2nd sub-paragraph, Regulation (EC) No. 726/2004): 20-21 February 2014, Bucharest, ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/overview-training-electronic-submission-information-medicines-new-pharmacovigilance-legislation-art-57-paragraph-2-2nd-sub-paragraph-regulation-ec-no-7262004-20-21-february-2014-bucharest_en.pdf"},
    {"id":"15316","name":"Withdrawal assessment report for Kiacta","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-06-16T02:00:00Z","last_updated_date":"2008-06-16T02:00:00Z","reference_number":"EMEA/CHMP/562687/2007","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-kiacta_en.pdf"},
    {"id":"15317","name":"Committee for Proprietary Medicinal Products (CPMP) 11th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1995-12-21T01:00:00Z","last_updated_date":"1995-12-21T01:00:00Z","reference_number":"CPMP/938/95","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-11th-plenary-meeting_en.pdf"},
    {"id":"15318","name":"Two new medicines for advanced kidney cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/496979/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/two-new-medicines-advanced-kidney-cancer_en.pdf"},
    {"id":"15320","name":"Checklist for requesting new EU sub-numbers (type IAIN and Type IB lead procedures only)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T18:30:00Z","last_updated_date":"2017-12-11T18:30:00Z","reference_number":"EMA/441692/2017","document_url":"https://www.ema.europa.eu/en/documents/template-form/checklist-requesting-new-eu-sub-numbers-type-iain-and-type-ib-lead-procedures-only_en.doc"},
    {"id":"15321","name":"Presentation - Disability assessment: can we combine responsiveness and clinical relevance? (Bernard Uitdehaag)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-disability-assessment-can-we-combine-responsiveness-and-clinical-relevance-bernard-uitdehaag_en.pdf"},
    {"id":"15323","name":"Reflection paper on consideration of adjuvants and preservatives under council regulation (EEC) No 2377/90 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal product...","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-12-17T01:00:00Z","last_updated_date":"2007-12-17T01:00:00Z","reference_number":"EMEA/CVMP/339116/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-consideration-adjuvants-and-preservatives-under-council-regulation-eec-no-237790-laying-down-community-procedure-establishment-maximum-residue-limits-veterinary-medicinal-product_en.pdf"},
    {"id":"15324","name":"Presentation - PSUR roadmap - Achieving a common understanding of the PSUR single assessment in Europe (Irene Rager)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-psur-roadmap-achieving-common-understanding-psur-single-assessment-europe-irene-rager_en.pdf"},
    {"id":"15325","name":"Presentation - Additional monitoring of medicines and side-effect reporting: Impact on the product information (C. Espinasse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-additional-monitoring-medicines-and-side-effect-reporting-impact-product-information-c-espinasse_en.pdf"},
    {"id":"15326","name":"Vortioxetine hydrobromide immediate release tablets 5 mg, 10 mg, 15 mg, and 20 mg; vortioxetine lactate oral drops solution 20 mg/ml product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"EMA/CHMP/474974/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vortioxetine-hydrobromide-immediate-release-tablets-5-mg-10-mg-15-mg-and-20-mg-vortioxetine-lactate-oral-drops-solution-20-mgml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"15328","name":"Declaration of interests: Paolo Tomasi","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:22Z","last_updated_date":"2016-09-08T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-paolo-tomasi_en.pdf"},
    {"id":"15330","name":"Reflection paper: Chemical, pharmaceutical and biological information to be included in dossiers when process analytical technology is employed","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-03-20T01:00:00Z","last_updated_date":"2006-03-20T01:00:00Z","reference_number":"EMEA/INS/277260/200","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-chemical-pharmaceutical-and-biological-information-be-included-dossiers-when-process-analytical-technology-employed_en.pdf"},
    {"id":"15332","name":"Presentation - Module 10 - Patient safety and pharmacovigilance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-10-patient-safety-and-pharmacovigilance_en.pdf"},
    {"id":"15334","name":"EU/3/13/1200: Public summary of opinion on orphan designation: Sorafenib tosylate for the treatment of papillary thyroid cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-12-02T01:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/COMP/637634/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131200-public-summary-opinion-orphan-designation-sorafenib-tosylate-treatment-papillary-thyroid-cancer_en.pdf"},
    {"id":"15336","name":"Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-04-24T02:00:00Z","last_updated_date":"2001-04-24T02:00:00Z","reference_number":"EMEA/CPMP/BWP/819/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-bovine-spongiform-encephalopathies-bse-and-vaccines-first-version_en.pdf"},
    {"id":"15337","name":"Presentation - Factor VIII and factor IX development plans at the Paediatric Committee: overview (Thorsten Olski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-factor-viii-and-factor-ix-development-plans-paediatric-committee-overview-thorsten-olski_en.pdf"},
    {"id":"15338","name":"European Commission-DG Health and Food Safety and European Medicines Agency action plan on advanced therapy medicinal products (ATMPs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-20T14:00:00Z","last_updated_date":"2020-07-10T17:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-dg-health-and-food-safety-and-european-medicines-agency-action-plan-advanced-therapy-medicinal-products-atmps_en.pdf"},
    {"id":"15339","name":"Agenda and registration form - eXtended EudraVigilance Medicinal\n\nProduct Dictionary training course 9-10 October 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T02:00:00Z","last_updated_date":"2014-09-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-training-course-9-10-october-2014_en.pdf"},
    {"id":"15340","name":"CVMP post-authorisation summary of negative opinion for Masivet","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/CVMP/198376/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-negative-opinion-masivet_en.pdf-0"},
    {"id":"15342","name":"EU/3/15/1471: Public summary of opinion on orphan designation: Trientine tetrahydrochloride for the treatment of Wilson's di","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2017-10-03T02:00:00Z","reference_number":"EMA/COMP/132991/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151471-public-summary-opinion-orphan-designation-trientine-tetrahydrochloride-treatment-wilsons-di_en.pdf"},
    {"id":"15343","name":"Paediatric Committee (PDCO) dates for 2009","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-09-23T02:00:00Z","last_updated_date":"2008-09-23T02:00:00Z","reference_number":"EMEA/PDCO/413468/2007-rev 2","document_url":"https://www.ema.europa.eu/en/documents/other/paediatric-committee-pdco-dates-2009_en.pdf"},
    {"id":"15347","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-12-31T01:00:00Z","last_updated_date":"2012-12-31T01:00:00Z","reference_number":"EMA/CHMP/ICH/544553/1998","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-guideline-e2c-r2-periodic-benefit-risk-evaluation-report-step-5_en.pdf"},
    {"id":"15348","name":"EMEA annual report shows 24 positive reviews for new human medicines in 2003. Agency proposes €108 million budget for 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-03-24T00:09:21Z","last_updated_date":"2004-03-24T00:09:21Z","reference_number":"EMEA/D/8348/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-annual-report-shows-24-positive-reviews-new-human-medicines-2003-agency-proposes-eu108-million-budget-2005_en.pdf"},
    {"id":"15350","name":"Letter of support for glutamate dehydrogenase, a biomarker of hepatocellular liver injury","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-28T15:55:00Z","last_updated_date":"2017-11-28T15:55:00Z","reference_number":"EMA/666090/20177","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-glutamate-dehydrogenase-biomarker-hepatocellular-liver-injury_en.pdf"},
    {"id":"15353","name":"Amendments to the Management Board implementing rules on the Agency’s fees","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T11:30:00Z","last_updated_date":"2011-12-20T11:30:00Z","reference_number":"EMA/MB/239263/2011","document_url":"https://www.ema.europa.eu/en/documents/other/amendments-management-board-implementing-rules-agencys-fees_en.pdf"},
    {"id":"15354","name":"EU/3/07/462: Public summary of positive opinion for orphan designation of recombinant human soluble Fc-gamma receptor II b for the treatment of idiopathic thrombocytopenic purpura","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2019-10-16T02:00:00Z","reference_number":"EMEA/COMP/143892/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307462-public-summary-positive-opinion-orphan-designation-recombinant-human-soluble-fc-gamma-receptor-ii-b-treatment-idiopathic-thrombocytopenic-purpura_en.pdf"},
    {"id":"15355","name":"Factor VIII Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/472176/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-review-started_en.pdf"},
    {"id":"15357","name":"Withdrawal assessment report for Intrinsa","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-10-26T02:00:00Z","last_updated_date":"2010-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-intrinsa_en.pdf"},
    {"id":"15360","name":"Agenda and registration form - First information day on periodic safety update reports – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E2C(R2) perio...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-04-17T19:00:00Z","last_updated_date":"2013-06-05T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-first-information-day-periodic-safety-update-reports-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-e2cr2-perio_en.pdf"},
    {"id":"15362","name":"Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus): List of nationally authorised medicinal products - PSUSA/00010345/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T12:25:00Z","last_updated_date":"2018-01-03T12:42:48Z","reference_number":"EMA/845743/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ibuprofen-ibuprofen-lysine-not-indicated-ductus-arteriosus-list-nationally-authorised-medicinal-products-psusa00010345201702_en.pdf"},
    {"id":"15363","name":"All presentations combined","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-03T02:09:21Z","last_updated_date":"2007-10-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/all-presentations-combined_en.pdf"},
    {"id":"15366","name":"EU/3/12/1014: Public summary of opinion on orphan designation: Talarozole for the treatment of keratinopathic ichthyosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2016-01-19T15:00:00Z","reference_number":"EMA/COMP/392964/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121014-public-summary-opinion-orphan-designation-talarozole-treatment-keratinopathic-ichthyosis_en.pdf"},
    {"id":"15367","name":"Gadoteridol: List of nationally authorised medicinal products - PSUSA/00001507/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T01:00:00Z","last_updated_date":"2016-10-18T16:56:40Z","reference_number":"EMA/186911/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteridol-list-nationally-authorised-medicinal-products-psusa00001507201504_en.pdf"},
    {"id":"15369","name":"Concept paper on a guideline on the chemical and pharmaceutical quality documentation concerning biological investigational medicinal products in clinical trials","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2008-02-21T01:00:00Z","reference_number":"EMEA/CHMP/BWP/466097/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-chemical-and-pharmaceutical-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials_en.pdf"},
    {"id":"15371","name":"CHMP summary of positive opinion for Pioglitazone Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/CHMP/559141/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pioglitazone-accord_en.pdf"},
    {"id":"15374","name":"Novartis Europharm Ltd. withdraws its application for an extension of indication for Zometa (zoledronic acid)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2010-12-15T01:00:00Z","reference_number":"EMA/818700/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/novartis-europharm-ltd-withdraws-its-application-extension-indication-zometa-zoledronic-acid_en.pdf"},
    {"id":"15376","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-07-17T12:08:00Z","last_updated_date":"2018-07-17T12:08:00Z","reference_number":"EMA/CAT/435550/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-june-2018_en.pdf"},
    {"id":"15378","name":"Questions and answers on the positive opinion on the marketing authorisation for Deltyba (delamanid): Outcome of re-examination","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T13:00:00Z","last_updated_date":"2013-11-22T13:00:00Z","reference_number":"EMA/713953/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-positive-opinion-marketing-authorisation-deltyba-delamanid-outcome-re-examination_en.pdf"},
    {"id":"15379","name":"Calculating 'chargeable units' for pharmacovigilance fees as specified in Regulation (EU) No 658/2014: guidance on how 'chargeable units' are derived from medicinal product information held within the 'Article 57' databa...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-21T14:00:00Z","last_updated_date":"2016-06-06T19:00:00Z","reference_number":"EMA/409768/2015","document_url":"https://www.ema.europa.eu/en/documents/other/calculating-chargeable-units-pharmacovigilance-fees-specified-regulation-eu-no-6582014-guidance-how-chargeable-units-are-derived-medicinal-product-information-held-within-article-57-databa_en.pdf"},
    {"id":"15380","name":"European Medicines Agency launches EudraPharm – the European medicines database","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-12-06T01:00:00Z","last_updated_date":"2006-12-06T01:00:00Z","reference_number":"EMEA/456119/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-eudrapharm-european-medicines-database_en.pdf"},
    {"id":"15382","name":"EU/3/17/1855: Public summary of opinion on orphan designation: Cannabidiol for the treatment of Lennox-Gastaut syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/143020/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171855-public-summary-opinion-orphan-designation-cannabidiol-treatment-lennox-gastaut-syndrome_en.pdf"},
    {"id":"15384","name":"Opinion following an Article 35 referral for veterinary medicinal products containing colistin to be administered orally","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-04-13T02:00:00Z","last_updated_date":"2015-04-13T02:00:00Z","reference_number":"EMA/160340/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-35-referral-veterinary-medicinal-products-containing-colistin-be-administered-orally_sv.pdf"}},
    {"id":"15385","name":"CHMP post-authorisation summary of positive opinion for Arzerra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/693024/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-arzerra_en.pdf"},
    {"id":"15386","name":"Presentation - Phase II/III adaptive design with treatment selection: A case study","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-phase-iiiii-adaptive-design-treatment-selection-case-study_en.pdf"},
    {"id":"15387","name":"ICH guideline Q4B annex 7 (R2) to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test - general chapter - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T12:00:00Z","reference_number":"EMA/CHMP/ICH/645469/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-7-r2-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-dissolution-test-general-chapter-step-5_en.pdf"},
    {"id":"15388","name":"Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-08T11:15:00Z","last_updated_date":"2018-03-08T11:21:00Z","reference_number":"EMA/44742/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/mifepristone-misoprostol-list-nationally-authorised-medicinal-products-psusa00010378201705_en.pdf"},
    {"id":"15389","name":"Paediatric addendum to CHMP guideline on clinical investigation of medicinal products in the treatment of lipid disorders","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-10-02T15:54:00Z","last_updated_date":"2012-10-02T15:54:00Z","reference_number":"EMA/CHMP/494506/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paediatric-addendum-chmp-guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders_en.pdf"},
    {"id":"15391","name":"COMP meeting report on the review of applications for orphan designation: June 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-06-24T11:20:00Z","last_updated_date":"2015-06-24T11:20:00Z","reference_number":"EMA/COMP/334381/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-june-2015_en.pdf"},
    {"id":"15392","name":"Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-12-18T01:00:00Z","last_updated_date":"2011-11-23T01:00:00Z","reference_number":"CPMP/EWP/18/01 final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-urinary-incontinence_en.pdf"},
    {"id":"15393","name":"European Medicines Agency gives new temporary treatment recommendations for Fabrazyme","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"EMA/257628/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-new-temporary-treatment-recommendations-fabrazyme_en.pdf"},
    {"id":"15394","name":"EU/3/17/1842: Public summary of opinion on orphan designation: Recombinant human club cell 10 KDa protein for the treatment of bronchiolitis obliterans syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/72259/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171842-public-summary-opinion-orphan-designation-recombinant-human-club-cell-10-kda-protein-treatment-bronchiolitis-obliterans-syndrome_en.pdf"},
    {"id":"15397","name":"CHMP summary of positive opinion for Afstyla","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/699392/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-afstyla_en.pdf"},
    {"id":"15399","name":"Nimesulide - Article 107 procedures - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-04-08T02:00:00Z","last_updated_date":"2010-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nimesulide-article-107-procedures-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nimesulide-article-107-procedures-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nimesulide-article-107-procedures-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nimesulide-article-107-procedures-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nimesulide-article-107-procedures-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nimesulide-article-107-procedures-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nimesulide-article-107-procedures-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nimesulide-article-107-procedures-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nimesulide-article-107-procedures-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nimesulide-article-107-procedures-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nimesulide-article-107-procedures-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nimesulide-article-107-procedures-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nimesulide-article-107-procedures-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nimesulide-article-107-procedures-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nimesulide-article-107-procedures-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nimesulide-article-107-procedures-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nimesulide-article-107-procedures-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nimesulide-article-107-procedures-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nimesulide-article-107-procedures-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nimesulide-article-107-procedures-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nimesulide-article-107-procedures-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nimesulide-article-107-procedures-annex-iii_sv.pdf"}},
    {"id":"15403","name":"Presentation - Modellers perspectives: how modelling and simulation can address gaps in knowledge (I. Skottheim Rusten)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modellers-perspectives-how-modelling-and-simulation-can-address-gaps-knowledge-i-skottheim-rusten_en.pdf"},
    {"id":"15404","name":"Working party on Herbal Medicinal Products: Position paper on the concomitant use of laxative bulk producers with medicinal products against diarrhoea","type":"position","status":"unknown","consultation_date":"","first_published_date":"2003-06-11T02:00:00Z","last_updated_date":"2003-06-11T02:00:00Z","reference_number":"EMEA/HMPWP/60/04","document_url":"https://www.ema.europa.eu/en/documents/position/working-party-herbal-medicinal-products-position-paper-concomitant-use-laxative-bulk-producers-medicinal-products-against-diarrhoea_en.pdf"},
    {"id":"15406","name":"Triptorelin : List of nationally authorised medicinal products - PSUSA/00003048/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-05T15:53:00Z","last_updated_date":"2017-12-05T15:57:03Z","reference_number":"EMA/803254/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/triptorelin-list-nationally-authorised-medicinal-products-psusa00003048201703_en.pdf"},
    {"id":"15407","name":"CHMP post-authorisation summary of positive opinion for Cialis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/293550/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cialis_en.pdf"},
    {"id":"15408","name":"Presentation - User testing of the clinical data publication website prototype (Frances Nuttall)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-user-testing-clinical-data-publication-website-prototype-frances-nuttall_en.pdf"},
    {"id":"15409","name":"Tamiflu IV compassionate-use programme - Closure of programme, EMEA/H/K/002287","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-30T17:52:00Z","last_updated_date":"2013-08-30T17:52:00Z","reference_number":"EMEA/H/K/002287","document_url":"https://www.ema.europa.eu/en/documents/other/tamiflu-iv-compassionate-use-programme-closure-programme-emeahk002287_en.pdf"},
    {"id":"15411","name":"Questions and answers on the recommendation to withdraw the marketing authorisations for Clobutinol-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2007-10-18T02:00:00Z","last_updated_date":"2007-10-18T02:00:00Z","reference_number":"EMEA/471052/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-recommendation-withdraw-marketing-authorisations-clobutinol-containing-medicines_en.pdf"},
    {"id":"15413","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Jakavi (ruxolitinib) for the treatment of chronic idiopathic myelofibrosis and myelofibrosis secondary to polycythaemia vera or...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2013-01-24T10:23:00Z","last_updated_date":"2013-01-24T10:23:00Z","reference_number":"EMA/COMP/299582/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-jakavi-ruxolitinib-treatment-chronic-idiopathic-myelofibrosis-and-myelofibrosis-secondary-polycythaemia-vera-or_en.pdf"},
    {"id":"15415","name":"Ex ante publicity for negotiated procurement procedure: Activiti training for business users - EMA/2016/32/HR","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-03-23T15:00:00Z","last_updated_date":"2016-03-23T15:00:00Z","reference_number":"EMA/215889/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procurement-procedure-activiti-training-business-users-ema201632hr_en.pdf"},
    {"id":"15416","name":"Topamax - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-12-15T00:08:21Z","last_updated_date":"2009-12-15T00:08:21Z","reference_number":"EMEA/CHMP/660222/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/topamax-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/topamax-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/topamax-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/topamax-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/topamax-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/topamax-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/topamax-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/topamax-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/topamax-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/topamax-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/topamax-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/topamax-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/topamax-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/topamax-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/topamax-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/topamax-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/topamax-article-30-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/topamax-article-30-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/topamax-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/topamax-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/topamax-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/topamax-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"15419","name":"Opinion following an Article 35 referral for all pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to 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    {"id":"15420","name":"Working party on Herbal Medicinal Products: Final proposal for a core data for  Psyllium seed","type":"other","status":"unknown","consultation_date":"","first_published_date":"2003-03-27T01:00:00Z","last_updated_date":"2003-03-27T01:00:00Z","reference_number":"EMEA/HMPWP/13/00","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-final-proposal-core-data-psyllium-seed_en.pdf"},
    {"id":"15421","name":"Presentation - Rationale for issuing the guideline and main Points (Rob Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rationale-issuing-guideline-and-main-points-rob-hemmings_en.pdf"},
    {"id":"15424","name":"Olodaterol / tiotropium: List of nationally authorised medicinal products - PSUSA/00010489/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-15T17:30:00Z","last_updated_date":"2018-01-15T17:30:00Z","reference_number":"EMA/27280/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/olodaterol-tiotropium-list-nationally-authorised-medicinal-products-psusa00010489201705_en.pdf"},
    {"id":"15425","name":"Presentation - Case 4: Goal: What does team plan for phase 2b trial?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-4-goal-what-does-team-plan-phase-2b-trial_en.pdf"},
    {"id":"15426","name":"CHMP summary of positive opinion for Onduarp","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-24T00:00:00Z","last_updated_date":"2014-04-03T00:00:00Z","reference_number":"EMA/CHMP/690726/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-onduarp_en.pdf"},
    {"id":"15427","name":"Presentation - CAT workplan 2015-2016 (Patrick Celis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-12T19:00:00Z","last_updated_date":"2015-05-12T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cat-workplan-2015-2016-patrick-celis_en.pdf"},
    {"id":"15428","name":"Presentation - Session 1: Defining and selecting populations, extrapolation of benefit between populations (Jan Mà¼ller-Berghaus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-09T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-defining-and-selecting-populations-extrapolation-benefit-between-populations-jan-ma-14ller-berghaus_en.pdf"},
    {"id":"15430","name":"'New quality paradigm: Quality by Design Design' ICH Q8 Q8-9-10 - Evdokia Korakianiti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/new-quality-paradigm-quality-design-design-ich-q8-q8-9-10-evdokia-korakianiti_en.pdf"},
    {"id":"15431","name":"EU/3/17/1854: Public summary of opinion on orphan designation: Autologous adipose tissue-derived mesenchymal stem cells for the treatment of thromboangiitis obliterans (Buerger's disease)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/138358/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171854-public-summary-opinion-orphan-designation-autologous-adipose-tissue-derived-mesenchymal-stem-cells-treatment-thromboangiitis-obliterans-buergers-disease_en.pdf"},
    {"id":"15433","name":"EU/3/15/1541: Public summary of opinion on orphan designation: Ibrutinib for the treatment of marginal zone lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2021-11-23T02:00:00Z","reference_number":"EMA/COMP/508544/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151541-public-summary-opinion-orphan-designation-ibrutinib-treatment-marginal-zone-lymphoma_en.pdf"},
    {"id":"15436","name":"Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Naftidrofuryl International Non-Proprietary Name (INN): Naftidrofuryl","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1996-06-26T02:08:21Z","last_updated_date":"1996-06-26T02:08:21Z","reference_number":"CPMP/578/95","document_url":"https://www.ema.europa.eu/en/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-naftidrofuryl-international-non-proprietary-name-inn-naftidrofuryl_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-naftidrofuryl-international-non-proprietary-name-inn-naftidrofuryl_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-naftidrofuryl-international-non-proprietary-name-inn-naftidrofuryl_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-naftidrofuryl-international-non-proprietary-name-inn-naftidrofuryl_fr.pdf"}},
    {"id":"15437","name":"Appendix 1: Proposed data elements relating to efficacy and to safety - CAR-T cell therapy registries workshop","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-05-22T11:52:00Z","last_updated_date":"2018-05-22T11:52:00Z","reference_number":"EMA/299528/2018","document_url":"https://www.ema.europa.eu/en/documents/report/appendix-1-proposed-data-elements-relating-efficacy-and-safety-car-t-cell-therapy-registries-workshop_en.pdf"},
    {"id":"15438","name":"Presentation - Lessons learnt by a national, generic network","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:51Z","last_updated_date":"2011-05-27T15:25:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lessons-learnt-national-generic-network_en.pdf"},
    {"id":"15439","name":"Presentation - Supply shortages of medicines in Europe (Franà§ois Houà¿ez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supply-shortages-medicines-europe-franassois-houaez_en.pdf"},
    {"id":"15440","name":"CHMP post-authorisation summary of positive opinion for Simponi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/339032/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-simponi_en.pdf-0"},
    {"id":"15441","name":"Status report on the implementation of the European Parliament and Council Regulation on orphan medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2002-04-08T02:00:00Z","last_updated_date":"2002-04-08T02:00:00Z","reference_number":"EMEA/7381/01","document_url":"https://www.ema.europa.eu/en/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_es.pdf","da":"https://www.ema.europa.eu/da/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_da.pdf","de":"https://www.ema.europa.eu/de/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_de.pdf","el":"https://www.ema.europa.eu/el/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_fr.pdf","it":"https://www.ema.europa.eu/it/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/report/status-report-implementation-european-parliament-and-council-regulation-orphan-medicinal-products_sv.pdf"}},
    {"id":"15444","name":"Appendix 1 - Pharmacovigilance inspection report template (Human)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-07-27T02:00:00Z","last_updated_date":"2016-04-04T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-1-pharmacovigilance-inspection-report-template-human_en.doc"},
    {"id":"15445","name":"Mitoxantrone: List of nationally authorised medicinal products - PSUSA/00002076/201606","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T11:00:00Z","last_updated_date":"2017-03-16T11:00:00Z","reference_number":"EMA/178876/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/mitoxantrone-list-nationally-authorised-medicinal-products-psusa00002076201606_en.pdf"},
    {"id":"15447","name":"Procedure for the appointment of the Executive Director","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/MB/400828/2009","document_url":"https://www.ema.europa.eu/en/documents/other/procedure-appointment-executive-director_en.pdf"},
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    {"id":"15455","name":"Agenda - CAT agenda of the 18-19 September 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-30T18:50:00Z","last_updated_date":"2014-09-30T18:50:00Z","reference_number":"EMA/CAT/541592/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-18-19-september-2014-meeting_en.pdf"},
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    {"id":"15458","name":"Presentation - Paediatric extrapolation in FDA submissions: sources of data (G. Burckart)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-extrapolation-fda-submissions-sources-data-g-burckart_en.pdf"},
    {"id":"15460","name":"Committee for Orphan Medicinal Products adopts 100th positive opinion on designation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-03-26T00:09:21Z","last_updated_date":"2002-03-26T00:09:21Z","reference_number":"EMEA/COMP/531/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-adopts-100th-positive-opinion-designation_en.pdf"},
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    {"id":"15466","name":"Draft guideline on the requirements for clinical documentation for Orally Inhaled Products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatme...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-10-18T02:00:00Z","last_updated_date":"2007-10-18T02:00:00Z","reference_number":"CPMP/EWP/4151/00 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-clinical-documentation-orally-inhaled-products-oip-including-requirements-demonstration-therapeutic-equivalence-between-two-inhaled-products-use-treatme_en.pdf"},
    {"id":"15467","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Autologous mature dendritic cells pulsed with tumour antigen-derived synthetic peptides","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T17:00:00Z","last_updated_date":"2015-03-02T17:00:00Z","reference_number":"EMA/107987/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-mature-dendritic-cells-pulsed-tumour-antigen-derived-synthetic-peptides_en.pdf"},
    {"id":"15468","name":"Summary Record of Focus group on promotion of pharmacovigilance for food producing animals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/summary-record-focus-group-promotion-pharmacovigilance-food-producing-animals_en.pdf"},
    {"id":"15472","name":"European Medicines Agency travel map","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-08-01T11:15:00Z","last_updated_date":"2014-08-01T11:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-travel-map_en.pdf"},
    {"id":"15475","name":"Declaration of interests: Sara Mendosa","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:17Z","last_updated_date":"2012-08-03T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-sara-mendosa_en.pdf"},
    {"id":"15476","name":"Rocuronium: List of nationally authorised medicinal products - PSUSA/00002656/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-08T16:00:00Z","last_updated_date":"2016-11-08T16:00:00Z","reference_number":"EMA/735249/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/rocuronium-list-nationally-authorised-medicinal-products-psusa00002656201602_en.pdf"},
    {"id":"15478","name":"Initial notices for parallel distribution – July 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-08-11T16:55:00Z","last_updated_date":"2014-09-09T18:45:00Z","reference_number":"EMA/485269/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-july-2014_en.pdf"},
    {"id":"15479","name":"Committee for Medicinal Products for Human Use (CHMP) - April 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-05-02T02:00:00Z","last_updated_date":"2003-05-02T02:00:00Z","reference_number":"EMEA/CPMP/2347/03","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-april-2003-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"15505","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-05-08T14:00:00Z","last_updated_date":"2017-05-08T14:00:00Z","reference_number":"EMA/PRAC/637349/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-prac-assessment-report_en.pdf"},
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    {"id":"15510","name":"COMP meeting report on the review of applications for orphan designation: October 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-10-15T16:55:00Z","last_updated_date":"2015-11-16T12:50:00Z","reference_number":"EMA/COMP/624217/2015 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-october-2015_en.pdf"},
    {"id":"15511","name":"Overview of comments received on guideline on determining the fate of veterinary medicinal products in manure","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-03-30T02:00:00Z","last_updated_date":"2011-03-30T02:00:00Z","reference_number":"EMA/CVMP/ERA/81952/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-determining-fate-veterinary-medicinal-products-manure_en.pdf"},
    {"id":"15514","name":"Phoxim (Extension to laying hens): Summary report (5) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2003-06-01T02:00:00Z","last_updated_date":"2003-06-01T02:00:00Z","reference_number":"EMEA/MRL/880/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phoxim-extension-laying-hens-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"15517","name":"Uwe Fiedler (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/uwe-fiedler-cv_en.pdf"},
    {"id":"15518","name":"Final list of references supporting the assessment of Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-08-24T17:00:00Z","last_updated_date":"2013-04-02T15:40:00Z","reference_number":"EMA/HMPC/571121/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-glycyrrhiza-glabra-l-andor-glycyrrhiza-inflata-bat-andor-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"15520","name":"Meeting of the EMEA working party on herbal medicinal products 24 and 25 February 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-03-28T01:00:00Z","last_updated_date":"2003-03-28T01:00:00Z","reference_number":"EMEA/HMPWP/1090/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-24-and-25-february-2003_en.pdf"},
    {"id":"15522","name":"Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram 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    {"id":"15523","name":"Withdrawal letter: Enpaxiq","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-enpaxiq_en.pdf"},
    {"id":"15524","name":"Overview of comments received on 'guideline for the processing of renewals in the centralised procedure'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-02T18:27:49Z","last_updated_date":"2012-07-02T18:27:49Z","reference_number":"EMA/257975/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-processing-renewals-centralised-procedure_en.pdf"},
    {"id":"15525","name":"EU/3/06/408: Public summary of positive opinion for orphan designation of\n\nhuman cytomegalovirus immunoglobulin for the prevention of congenital cytomegalovirus infection following primary cytomegalovirus infection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/178305/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306408-public-summary-positive-opinion-orphan-designation-human-cytomegalovirus-immunoglobulin-prevention-congenital-cytomegalovirus-infection-following-primary-cytomegalovirus-infection_en.pdf"},
    {"id":"15526","name":"Annex 07 Draft Framework service contract - Procurement Procedure EMA/2012/09/IF","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-07-draft-framework-service-contract-procurement-procedure-ema201209if_en.pdf"},
    {"id":"15527","name":"Withdrawal assessment report for Fulphila","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2018-05-29T17:16:00Z","last_updated_date":"2018-05-29T17:16:00Z","reference_number":"EMA/523054/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-fulphila_en.pdf"},
    {"id":"15529","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T11:40:00Z","last_updated_date":"2014-07-30T11:40:00Z","reference_number":"EMA/CAT/434851/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-july-2014-meeting_en.pdf"},
    {"id":"15530","name":"Committee for Advanced Therapies (CAT) rules of procedure","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-03-13T01:00:00Z","last_updated_date":"2022-11-17T09:09:00Z","reference_number":"EMA/CAT/454446/2008 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/committee-advanced-therapies-cat-rules-procedure_en.pdf"},
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    {"id":"15535","name":"Superseded opinion of the HMPC on a community herbal monograph on Ribes nigrum L., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-06-30T02:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"EMA/HMPC/615038/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-ribes-nigrum-l-folium_en.pdf"},
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    {"id":"15588","name":"Advances in Croatia's rapproachment to the EU - Sinisa Tomic","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/advances-croatias-rapproachment-eu-sinisa-tomic_en.pdf"},
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    {"id":"15594","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  Mycograb","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2007-03-23T00:09:21Z","last_updated_date":"2007-03-23T00:09:21Z","reference_number":"EMEA/129723/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-mycograb_en.pdf"},
    {"id":"15595","name":"Overview of comments received on public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bir...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T18:30:00Z","last_updated_date":"2014-12-12T18:30:00Z","reference_number":"EMA/715812/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-public-consultation-regarding-request-european-medicines-agency-european-commission-scientific-opinion-regarding-risks-vultures-and-other-necrophagous-bir_en.pdf"},
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    {"id":"15610","name":"Withdrawal assessment report for Evoltra","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-04-09T02:00:00Z","last_updated_date":"2008-04-09T02:00:00Z","reference_number":"EMEA/184556/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-evoltra_en.pdf"},
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    {"id":"15614","name":"Concept paper on the development of a guideline on viral safety evaluation of biotechnological products to be used in clinical trials","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-12-15T01:00:00Z","last_updated_date":"2004-12-15T01:00:00Z","reference_number":"EMEA/CHMP/BWP/124447/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-viral-safety-evaluation-biotechnological-products-be-used-clinical-trials_en.pdf"},
    {"id":"15615","name":"Presentation - Next steps - timelines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:46Z","last_updated_date":"2011-05-27T15:25:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-next-steps-timelines_en.pdf"},
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    {"id":"15617","name":"European Medicines Agency recommends withdrawal of dextropropoxyphene-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/401062/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-withdrawal-dextropropoxyphene-containing-medicines_en.pdf"},
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    {"id":"15620","name":"Presentation - Directorate General  for Research and Innovation perspective (Antoine Mialhe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-directorate-general-research-and-innovation-perspective-antoine-mialhe_en.pdf"},
    {"id":"15621","name":"Questions and answers on the withdrawal of the marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-01-28T01:00:00Z","last_updated_date":"2010-01-28T01:00:00Z","reference_number":"EMA/23377/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-ibuprofendiphenhydramine-hydrochloride-wyeth_sv.pdf"}},
    {"id":"15622","name":"EU/3/09/659: Public summary of positive opinion for orphan designation of tosedostat for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-11T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMEA/COMP/395735/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309659-public-summary-positive-opinion-orphan-designation-tosedostat-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"15624","name":"Human tetanus immunoglobulin: List of nationally authorised medicinal products - PSUSA/00002909/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T18:55:00Z","last_updated_date":"2018-04-18T18:55:00Z","reference_number":"EMA/221460/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-tetanus-immunoglobulin-list-nationally-authorised-medicinal-products-psusa00002909201708_en.pdf"},
    {"id":"15626","name":"Substances related to nicotinic acid Article-31 referral - Draft Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-08-15T02:00:00Z","reference_number":"EMA/148540/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-draft-annex-i_en.pdf"},
    {"id":"15628","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n15-18 December 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T00:09:21Z","last_updated_date":"2008-12-18T00:09:21Z","reference_number":"EMEA/CHMP/670724/2008-corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-15-18-december-2008_en.pdf"},
    {"id":"15629","name":"Hydroxyethyl starch Article-107i referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-notification_en.pdf"},
    {"id":"15631","name":"Presentation - EMA/EGA workshop - Session 4: Line extension of immediate release products (Alfredo Garcia Arieta)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-4-line-extension-immediate-release-products-alfredo-garcia-arieta_en.pdf"},
    {"id":"15633","name":"Superseded opinion of the HMPC on a Community herbal monograph on Plantago ovata Forssk., semen","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-07-13T02:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/353198/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-plantago-ovata-forssk-semen_en.pdf"},
    {"id":"15634","name":"EU/3/17/1914 : Public summary of opinion on orphan designation : (S)-3-((S)-2-(2-((2,6-difluorophenyl)amino)-2-oxoacetamido)propanamido)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid for the treatment of primary scl...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T15:38:00Z","last_updated_date":"2018-01-08T15:38:00Z","reference_number":"EMA/629138/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171914-public-summary-opinion-orphan-designation-s-3-s-2-2-26-difluorophenylamino-2-oxoacetamidopropanamido-4-oxo-5-2356-tetrafluorophenoxypentanoic-acid-treatment-primary-scl_en.pdf"},
    {"id":"15635","name":"Sulfogaiacol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/539/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sulfogaiacol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"15639","name":"Animal health companies experience, Guillaume Agede, IFAH-Europe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/animal-health-companies-experience-guillaume-agede-ifah-europe_en.pdf"},
    {"id":"15642","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 20-23 April 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-04-29T17:10:00Z","last_updated_date":"2015-04-29T17:10:00Z","reference_number":"EMA/28004/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-20-23-april-2015_en.pdf"},
    {"id":"15645","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Eviplera (emtricitabine / rilpivirine / tenofovir disoproxil)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/CHMP/447729/2013 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-eviplera-emtricitabine-rilpivirine-tenofovir-disoproxil_en.pdf"},
    {"id":"15646","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2015 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T13:40:00Z","last_updated_date":"2015-05-04T13:40:00Z","reference_number":"EMA/CAT/268414/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2015-meeting_en.pdf"},
    {"id":"15647","name":"Draft list of references for assessment of: Pimpinella anisum L., fructus and aetheroleum (aniseed and anise oil)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-09-07T02:09:21Z","last_updated_date":"2007-09-07T02:09:21Z","reference_number":"EMEA/HMPC/359388/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-pimpinella-anisum-l-fructus-and-aetheroleum-aniseed-and-anise-oil_en.pdf"},
    {"id":"15651","name":"Cilostazol-containing medicines - Article-31 referral - Annex I (cilostazol)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T00:00:00Z","last_updated_date":"2013-09-11T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-i-cilostazol_sv.pdf"}},
    {"id":"15652","name":"Programme - EMA workshop on qualification and reporting of physiologically-based pharmacokinetic (PBPK) modelling and simulation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T17:54:00Z","last_updated_date":"2016-11-17T16:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/programme-ema-workshop-qualification-and-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-and-simulation_en.pdf"},
    {"id":"15653","name":"Letter from the European Medicines Agency and the European Commission to the Food and Drug Administration","type":"other","status":"unknown","consultation_date":"","first_published_date":"2003-09-12T02:00:00Z","last_updated_date":"2003-09-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-medicines-agency-and-european-commission-food-and-drug-administration_en.pdf"},
    {"id":"15654","name":"European Medicines Agency starts infringement procedure to investigate Roche’s alleged non-compliance with pharmacovigilance obligations","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-10-23T14:00:00Z","last_updated_date":"2012-10-23T14:00:00Z","reference_number":"EMA/666493/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-infringement-procedure-investigate-roches-alleged-non-compliance-pharmacovigilance-obligations_en.pdf"},
    {"id":"15655","name":"EU/3/09/654: Public summary of positive opinion for orphan designation of hypothiocyanite / lactoferrin for the treatment","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-13T02:00:00Z","last_updated_date":"2010-10-13T02:00:00Z","reference_number":"EMEA/COMP/392984/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309654-public-summary-positive-opinion-orphan-designation-hypothiocyanite-lactoferrin-treatment_en.pdf"},
    {"id":"15657","name":"Peer review of the certification procedure","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-12-17T15:50:00Z","last_updated_date":"2014-12-17T15:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/peer-review-certification-procedure_en.doc"},
    {"id":"15658","name":"CHMP summary of positive opinion for Vemlidy","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T01:00:00Z","last_updated_date":"2016-11-11T01:00:00Z","reference_number":"EMA/704543/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vemlidy_en.pdf"},
    {"id":"15659","name":"Guideline on the replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/BWP/452081/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-replacement-rabbit-pyrogen-testing-alternative-test-plasma-derived-medicinal-products_en.pdf"},
    {"id":"15660","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Autologous skeletal muscle-derived-cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T13:30:00Z","last_updated_date":"2013-03-11T13:30:00Z","reference_number":"EMA/51048/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-skeletal-muscle-derived-cells_en.pdf"},
    {"id":"15661","name":"CVMP assessment report: feline endogenous retrovirus RD114 in some live attenuated vaccines commercially available in the EU for use in animals","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-10-14T14:23:59Z","last_updated_date":"2010-10-14T14:23:59Z","reference_number":"EMA/CVMP/300321/2010","document_url":"https://www.ema.europa.eu/en/documents/report/cvmp-assessment-report-feline-endogenous-retrovirus-rd114-some-live-attenuated-vaccines-commercially-available-eu-use-animals_en.pdf"},
    {"id":"15662","name":"EU/3/13/1131: Public summary of opinion on orphan designation: Recombinant human CXCL8 mutant for the treatment of cystic fibrosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-06-25T19:00:00Z","reference_number":"EMA/COMP/272544/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131131-public-summary-opinion-orphan-designation-recombinant-human-cxcl8-mutant-treatment-cystic-fibrosis_en.pdf"},
    {"id":"15663","name":"Public statement on Clopidogrel/Acetylsalicylic acid Teva: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-04-28T02:00:00Z","last_updated_date":"2017-04-28T02:00:00Z","reference_number":"EMA/252355/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrelacetylsalicylic-acid-teva-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"15668","name":"PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T14:00:00Z","last_updated_date":"2013-10-11T14:00:00Z","reference_number":"EMA/607314/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-confirms-benefits-all-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_en.pdf"},
    {"id":"15669","name":"Beclometasone / formoterol (inhalative application): List of nationally authorised medicinal products - PSUSA/00010068/201607","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-14T17:30:00Z","last_updated_date":"2017-03-14T17:38:01Z","reference_number":"EMA/171073/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/beclometasone-formoterol-inhalative-application-list-nationally-authorised-medicinal-products-psusa00010068201607_en.pdf"},
    {"id":"15672","name":"Presentation - Role of modelling and simulation in regulatory decision making in Europe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:30:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-modelling-and-simulation-regulatory-decision-making-europe_en.pdf"},
    {"id":"15675","name":"Surrogate endpoints in cardiovascular research and regulatory implications - Pieter de Graeff","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-12-16T00:09:21Z","last_updated_date":"2005-12-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/surrogate-endpoints-cardiovascular-research-and-regulatory-implications-pieter-de-graeff_en.pdf"},
    {"id":"15676","name":"Public statement on Zoledronic acid Teva Generics: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-08-08T02:00:00Z","last_updated_date":"2016-08-08T02:00:00Z","reference_number":"EMA/528126/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zoledronic-acid-teva-generics-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"15677","name":"Updated measures for pregnancy prevention during retinoid use","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2018-03-23T13:00:00Z","reference_number":"EMA/165360/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/updated-measures-pregnancy-prevention-during-retinoid-use_en.pdf"},
    {"id":"15679","name":"Third report on the progress of the interaction with Patients' and Consumers' Organisations during 2009: Management Board meeting 7 October 2010","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/MB/599720/2010","document_url":"https://www.ema.europa.eu/en/documents/report/third-report-progress-interaction-patients-and-consumers-organisations-during-2009-management-board-meeting-7-october-2010_en.pdf"},
    {"id":"15680","name":"Advisory notice to veterinary surgeons regarding the development of fibrosarcomas at sites of injection of veterinary medicinal products in cats","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-01-01T01:00:00Z","last_updated_date":"2003-01-01T01:00:00Z","reference_number":"EMEA/CVMP/205/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/advisory-notice-veterinary-surgeons-regarding-development-fibrosarcomas-sites-injection-veterinary-medicinal-products-cats_en.pdf"},
    {"id":"15683","name":"Draft list of references supporting the assessment of Viscum album L., herba","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-10-20T11:30:10Z","last_updated_date":"2011-10-20T11:30:10Z","reference_number":"EMA/HMPC/246781/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-viscum-album-l-herba_en.pdf"},
    {"id":"15684","name":"EU/3/15/1455: Public summary of positive opinion for orphan designation of human plasma-derived alpha-1 proteinase inhibitor for the treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/127023/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151455-public-summary-positive-opinion-orphan-designation-human-plasma-derived-alpha-1-proteinase-inhibitor-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"15686","name":"Draft list of references supporting the assessment of Glycine max (L.) Merr., semen - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2017-02-28T01:00:00Z","last_updated_date":"2017-02-28T01:00:00Z","reference_number":"EMA/607531/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-glycine-max-l-merr-semen-first-version_en.pdf"},
    {"id":"15687","name":"Agenda - Vaccines Working Party closed workshop on correlates for the protection and serological assays for influenza vaccines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-06-05T11:15:00Z","last_updated_date":"2013-06-05T11:15:00Z","reference_number":"EMA/CHMP/VWP/263668/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-vaccines-working-party-closed-workshop-correlates-protection-and-serological-assays-influenza-vaccines_en.pdf"},
    {"id":"15688","name":"EU/3/08/562: Public summary of positive opinion for orphan designation of topotecan hydrochloride (liposomal) for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/450103/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308562-public-summary-positive-opinion-orphan-designation-topotecan-hydrochloride-liposomal-treatment-glioma_en.pdf"},
    {"id":"15690","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 15-17 March 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-03-18T01:00:00Z","reference_number":"EMA/CVMP/169459/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-15-17-march-2016_en.pdf"},
    {"id":"15694","name":"Declaration of interests: Peter Richardson","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:06:00Z","last_updated_date":"2019-10-25T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-peter-richardson_en.pdf"},
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    {"id":"15696","name":"Coumafos: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/489/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/coumafos-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"15698","name":"Benzyl alcohol and benzoic acid group used as excipients\n\nReport published in support of the ‘Questions and answers on benzyl alcohol used as an excipient in medicinal products for human use’ (EMA/CHMP/508188/2013) and t...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/272866/2013","document_url":"https://www.ema.europa.eu/en/documents/report/benzyl-alcohol-and-benzoic-acid-group-used-excipients-report-published-support-questions-and-answers-benzyl-alcohol-used-excipient-medicinal-products-human-use-emachmp5081882013-and-t_en.pdf"},
    {"id":"15701","name":"Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer's disease and other dementias","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-10-30T13:00:00Z","last_updated_date":"2014-11-20T17:50:00Z","reference_number":"EMA/CHMP/539931/2014 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/discussion-paper-clinical-investigation-medicines-treatment-alzheimers-disease-and-other-dementias_en.pdf"},
    {"id":"15703","name":"Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-04-30T02:00:00Z","last_updated_date":"2010-04-30T02:00:00Z","reference_number":"CHMP/EWP/1343/01 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-antifungal-agents-treatment-and-prophylaxis-invasive-fungal-disease_en.pdf"},
    {"id":"15704","name":"Presentation - Day 2: Prevention of graft rejection","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-prevention-graft-rejection_en.pdf"},
    {"id":"15706","name":"Public statement on Paglitaz: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-03-10T12:04:00Z","last_updated_date":"2016-03-10T12:04:00Z","reference_number":"EMEA/H/C/002309","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-paglitaz-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"15707","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 24 – 27 June 2013","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/CHMP/SAWP/389179/2013","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-24-27-june-2013_en.pdf"},
    {"id":"15708","name":"Transparency - Leng Heng","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-08T02:00:00Z","last_updated_date":"2003-05-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/transparency-leng-heng_en.pdf"},
    {"id":"15711","name":"Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: List of nationally authorised medicinal products - PSUSA/00001696/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-22T17:00:00Z","last_updated_date":"2018-06-22T17:00:00Z","reference_number":"EMA/423869/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxyzine-chloride-hydroxyzine-pamoate-and-all-fixed-combination-hydroxyzine-list-nationally-authorised-medicinal-products-psusa00001696201711_en.pdf"},
    {"id":"15712","name":"Ibuprofen and dexibuprofen Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T17:00:00Z","last_updated_date":"2015-03-16T17:00:00Z","reference_number":"EMA/PRAC/332908/2014 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"15716","name":"Opinion following an Article-33(4) referral for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-15T17:00:00Z","last_updated_date":"2013-03-15T17:00:00Z","reference_number":"EMEA/V/A/084","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-melosolute-40-mgml-solution-injection-cattle-pigs-and-horses_sv.pdf"}},
    {"id":"15717","name":"Agenda - PRAC draft agenda of meeting 6-9 October 2014","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-10-06T19:30:00Z","last_updated_date":"2014-10-06T19:30:00Z","reference_number":"EMA/PRAC/463490/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-6-9-october-2014_en.pdf"},
    {"id":"15720","name":"Committee for medicinal products for veterinary use: Meeting of 11-12 January 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-01-13T12:49:21Z","last_updated_date":"2005-01-13T12:49:21Z","reference_number":"EMEA/CVMP/1947/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-11-12-january-2005_en.pdf"},
    {"id":"15722","name":"European Medicines Agency publishes updated set of mandatory Article 57(2) requirements for marketing authorisation holders","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T13:00:00Z","last_updated_date":"2012-03-05T13:00:00Z","reference_number":"EMA/139333/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-publishes-updated-set-mandatory-article-572-requirements-marketing-authorisation-holders_en.pdf"},
    {"id":"15724","name":"Decision of the Management Board - On the appointment of the accounting officer of the European Medicines Agency","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T17:00:00Z","last_updated_date":"2017-03-17T17:00:00Z","reference_number":"EMA/MB/27838/2017","document_url":"https://www.ema.europa.eu/en/documents/other/decision-management-board-appointment-accounting-officer-european-medicines-agency_en.pdf"},
    {"id":"15726","name":"Questions and answers on the use of angiotensin ii receptor antagonists during pregnancy","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/218318/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-use-angiotensin-ii-receptor-antagonists-during-pregnancy_en.pdf"},
    {"id":"15727","name":"Pandemrix: Summary of product characteristics","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-15T01:00:00Z","last_updated_date":"2010-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pandemrix-summary-product-characteristics_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/pandemrix-summary-product-characteristics_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/pandemrix-summary-product-characteristics_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/pandemrix-summary-product-characteristics_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/pandemrix-summary-product-characteristics_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/pandemrix-summary-product-characteristics_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/pandemrix-summary-product-characteristics_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/pandemrix-summary-product-characteristics_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/pandemrix-summary-product-characteristics_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/pandemrix-summary-product-characteristics_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/pandemrix-summary-product-characteristics_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/pandemrix-summary-product-characteristics_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/pandemrix-summary-product-characteristics_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/pandemrix-summary-product-characteristics_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/pandemrix-summary-product-characteristics_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/pandemrix-summary-product-characteristics_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/pandemrix-summary-product-characteristics_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/pandemrix-summary-product-characteristics_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/pandemrix-summary-product-characteristics_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/pandemrix-summary-product-characteristics_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/pandemrix-summary-product-characteristics_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/pandemrix-summary-product-characteristics_sv.pdf"}},
    {"id":"15728","name":"Presentation - PHARMACHILD: A European collaboration on long term outcome and pharmacovigilance for biologics used in Juvenile Idiopathic Arthritis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmachild-european-collaboration-long-term-outcome-and-pharmacovigilance-biologics-used-juvenile-idiopathic-arthritis_en.pdf"},
    {"id":"15729","name":"Work instructions for marketing status and sunset clause monitoring for centrally authorised veterinary medicinal products","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2017-05-12T15:45:00Z","last_updated_date":"2017-05-12T15:45:00Z","reference_number":"WIN/V/4125","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-marketing-status-and-sunset-clause-monitoring-centrally-authorised-veterinary-medicinal-products_en.pdf"},
    {"id":"15730","name":"Questions and answers on refusal of marketing authorisation for Translarna","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/36356/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-translarna_en.pdf"},
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    {"id":"15782","name":"Committee for medicinal products for human use, summary of positive opinion for Lamivudine Teva Pharma B.V.","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/582879/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-lamivudine-teva-pharma-bv_en.pdf"},
    {"id":"15783","name":"2016 and 2017 annual report on independence","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-04-13T16:00:00Z","last_updated_date":"2018-04-13T16:00:00Z","reference_number":"EMA/463632/2017","document_url":"https://www.ema.europa.eu/en/documents/report/2016-and-2017-annual-report-independence_en.pdf"},
    {"id":"15784","name":"Durogesic Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-10-13T02:00:00Z","last_updated_date":"2016-10-13T02:00:00Z","reference_number":"EMA/641560/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/durogesic-article-30-referral-assessment-report_en.pdf"},
    {"id":"15785","name":"ICH: Q 4 B: Note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/222007/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-step-3_en.pdf"},
    {"id":"15792","name":"EMA Management Board: highlights of March 2016 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-03-21T11:28:00Z","last_updated_date":"2016-03-21T11:28:00Z","reference_number":"EMA/205682/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-march-2016-meeting_en.pdf"},
    {"id":"15793","name":"CHMP post-authorisation summary of positive opinion for Angiox  22 October 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:09:21Z","last_updated_date":"2018-09-14T02:09:21Z","reference_number":"EMEA/CHMP/671740/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-angiox-22-october-2009_en.pdf"},
    {"id":"15794","name":"Organisational matters - CHMP meeting 22-25 April 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T17:40:00Z","last_updated_date":"2014-05-02T12:10:00Z","reference_number":"EMA/124017/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-22-25-april-2014_en.pdf"},
    {"id":"15795","name":"Presentation - Multi-stakeholder late and early dialogue (S. Vamvakas, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-stakeholder-late-and-early-dialogue-s-vamvakas-ema_en.pdf"},
    {"id":"15796","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - July 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-07-31T02:00:00Z","last_updated_date":"2008-07-31T02:00:00Z","reference_number":"EMEA/444404/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-july-2008_en.pdf"},
    {"id":"15797","name":"CHMP post-authorisation summary of positive opinion for Invega","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/CHMP/245423/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-invega_en.pdf-0"},
    {"id":"15798","name":"Questions and answers on the refusal of the marketing authorisation for Folotyn","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/CHMP/32841/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn_en.pdf"},
    {"id":"15799","name":"Withdrawal assessment report for Sinerem","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-04-17T02:00:00Z","last_updated_date":"2008-04-17T02:00:00Z","reference_number":"EMEA/CHMP/11527/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-sinerem_en.pdf"},
    {"id":"15800","name":"Public summary of the evaluation of the proposed paediatric investigation plan: D-Argininamide, N-acetyl-D-cysteinyl-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-, disulfide with L-cysteine (AMG 416) for treatment of ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-25T12:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/686541/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-d-argininamide-n-acetyl-d-cysteinyl-d-alanyl-d-arginyl-d-arginyl-d-arginyl-d-alanyl-disulfide-l-cysteine-amg-416-treatment_en.pdf"},
    {"id":"15801","name":"Hydrochlorothiazide moexipril: List of nationally authorised medicinal products - PSUSA/00002082/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-12T16:38:00Z","last_updated_date":"2018-03-12T16:41:15Z","reference_number":"EMA/113527/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-moexipril-list-nationally-authorised-medicinal-products-psusa00002082201706_en.pdf"},
    {"id":"15802","name":"Agenda - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCPWG) joint meeting - February 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-02-25T12:00:00Z","last_updated_date":"2013-05-24T18:00:00Z","reference_number":"EMA/810501/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-group-hcpwg-joint-meeting-february-2013_en.pdf"},
    {"id":"15803","name":"Overview of comments received on draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-01-10T01:00:00Z","last_updated_date":"2008-01-10T01:00:00Z","reference_number":"EMEA/HMPC/539645/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-draft-guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-first-version_en.pdf"},
    {"id":"15805","name":"EU/3/14/1298: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine r...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T17:30:00Z","last_updated_date":"2014-09-01T17:30:00Z","reference_number":"EMA/COMP/360842/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141298-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-antithrombin-mrna-and-covalently-linked-ligand-containing-three-n_en.pdf"},
    {"id":"15807","name":"Closantel (bovine and ovine milk): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-04-13T15:45:00Z","last_updated_date":"2012-04-13T15:45:00Z","reference_number":"EMA/CVMP/813350/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/closantel-bovine-and-ovine-milk-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"15808","name":"Overview of comments received on draft guidance document on qualification of biomarkers","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/380215/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-guidance-document-qualification-biomarkers_en.pdf"},
    {"id":"15809","name":"European Union herbal monograph on Centaurium erythraea Rafn. s.l., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"EMA/HMPC/277493/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/european-union-herbal-monograph-centaurium-erythraea-rafn-sl-herba_en.pdf"},
    {"id":"15811","name":"Linezolid : List of nationally authorised medicinal products - PSUSA/00001888/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-07T15:06:00Z","last_updated_date":"2017-12-07T15:10:56Z","reference_number":"EMA/811742/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/linezolid-list-nationally-authorised-medicinal-products-psusa00001888201704_en.pdf"},
    {"id":"15812","name":"Mandate of the European network of paediatric research-European Medicines Agency working groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T16:00:00Z","last_updated_date":"2021-03-10T16:51:00Z","reference_number":"EMA/493016/2013","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-european-network-paediatric-research-european-medicines-agency-working-groups_en.pdf"},
    {"id":"15813","name":"First report on the progress of the interaction with patients’ and consumers’ organisations and analysis of the degree of satisfaction of patients and consumers involved in European Medicines Agency activities during 200...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2008-02-07T01:00:00Z","last_updated_date":"2008-02-07T01:00:00Z","reference_number":"EMEA/478814/2007","document_url":"https://www.ema.europa.eu/en/documents/report/first-report-progress-interaction-patients-and-consumers-organisations-and-analysis-degree-satisfaction-patients-and-consumers-involved-european-medicines-agency-activities-during-200_en.pdf"},
    {"id":"15814","name":"Presentation - Accession Preparation: Situation in Croatia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accession-preparation-situation-croatia_en.pdf"},
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    {"id":"15823","name":"CHMP post-authorisation summary of positive opinion for Keytruda (II-42;II-43)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/481048/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-42ii-43_en.pdf"},
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    {"id":"15834","name":"Committee for Medicinal Products for Human Use (CHMP) - September 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-09-28T02:00:00Z","last_updated_date":"2007-09-28T02:00:00Z","reference_number":"EMEA/427480/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-september-2007-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"15838","name":"Superseded list of references supporting the assessment of Ribes nigrum L., folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2010-06-30T02:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"EMA/HMPC/143130/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-ribes-nigrum-l-folium_en.pdf"},
    {"id":"15840","name":"Points to consider on application with 1.meta-analyses, 2.one pivotal study","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-05-31T02:00:00Z","last_updated_date":"2001-05-31T02:00:00Z","reference_number":"CPMP/EWP/2330/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-application-1meta-analyses-2one-pivotal-study_en.pdf"},
    {"id":"15842","name":"Presentation - Minimising harm through education (Tony West)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-minimising-harm-through-education-tony-west_en.pdf"},
    {"id":"15844","name":"Monthly Report - Pharmacovigilance Working Party (PhVWP) September 2010 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-10-01T02:00:00Z","last_updated_date":"2010-10-01T02:00:00Z","reference_number":"EMA/CHMP/PhVWP/589053/2010","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-september-2010-plenary-meeting_en.pdf"},
    {"id":"15845","name":"Superseded opinion of the HMPC on a Community herbal monograph on Cassia senna L, fructus and Cassia angustifolia Vahl, fructus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-09-07T02:09:00Z","last_updated_date":"2006-09-07T02:09:00Z","reference_number":"EMEA/HMPC/429430/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-cassia-senna-l-fructus-and-cassia-angustifolia-vahl-fructus_en.pdf"},
    {"id":"15848","name":"Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Zagam 100mg and Annex","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1996-05-06T02:08:21Z","last_updated_date":"1996-05-06T02:08:21Z","reference_number":"CPMP/931/95","document_url":"https://www.ema.europa.eu/en/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-100mg-and-annex_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-100mg-and-annex_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-100mg-and-annex_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-100mg-and-annex_fr.pdf"}},
    {"id":"15849","name":"Public statement on Viracept: Non-renewal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-01-25T15:35:00Z","last_updated_date":"2013-01-25T15:35:00Z","reference_number":"EMA/21055/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-viracept-non-renewal-marketing-authorisation-european-union_en.pdf"},
    {"id":"15851","name":"Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2016-10-18T11:29:36Z","reference_number":"EMA/850509/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/metformin-list-nationally-authorised-medicinal-products-psusa00002001201504_en.pdf"},
    {"id":"15853","name":"Minutes - Highlights from the 11th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-07-25T16:03:00Z","last_updated_date":"2017-07-25T16:03:00Z","reference_number":"EMA/369620/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-highlights-11th-ema-industry-platform-meeting-operation-eu-pharmacovigilance-legislation_en.pdf"},
    {"id":"15854","name":"Superseded overview of comments received on Community herbal monograph on Pelargonium sidoides DC and / or Pelargonium reniforme Curt., radix - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2013-02-04T12:30:00Z","last_updated_date":"2018-08-20T13:30:00Z","reference_number":"EMA/HMPC/748350/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-pelargonium-sidoides-dc-and-or-pelargonium-reniforme-curt-radix-first-version_en.pdf"},
    {"id":"15855","name":"EU/3/06/398: Public summary of positive opinion for orphan designation of\n\nH-Val-Ile-Val-Lys-Leu-Ile-Pro-Ser-Thr-Ser-Ser-Ala-Val-Asp-Thr-Pro-Tyr-Leu-Asp-Ile-Thr-Tyr-His-Phe-Val-Ala-Gln-Arg-Leu-Pro-Leu-OH for the treatmen...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/229279/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306398-public-summary-positive-opinion-orphan-designation-h-val-ile-val-lys-leu-ile-pro-ser-thr-ser-ser-ala-val-asp-thr-pro-tyr-leu-asp-ile-thr-tyr-his-phe-val-ala-gln-arg-leu-pro-leu-oh-treatmen_en.pdf"},
    {"id":"15857","name":"Presentation - Agenda item 3: substances and products - Reports from  the subgroup","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-10-29T01:00:00Z","last_updated_date":"2015-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-item-3-substances-and-products-reports-subgroup_en.pdf"},
    {"id":"15859","name":"CHMP post-authorisation summary of positive opinion for Uptravi (II-07)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T02:00:00Z","last_updated_date":"2017-05-19T02:00:00Z","reference_number":"EMA/CHMP/315335/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-uptravi-ii-07_en.pdf"},
    {"id":"15861","name":"Standard operating procedure for cover during out of Agency office hours for a potentially serious problem with a centrally authorised product","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-06-18T02:00:00Z","last_updated_date":"2010-12-08T01:00:00Z","reference_number":"SOP/EMA/0087","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-cover-during-out-agency-office-hours-potentially-serious-problem-centrally-authorised-product_en.pdf"},
    {"id":"15865","name":"Eprosartan: List of nationally authorised medicinal products - PSUSA/00001243/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-17T16:06:00Z","last_updated_date":"2018-01-17T16:08:13Z","reference_number":"EMA/32390/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/eprosartan-list-nationally-authorised-medicinal-products-psusa00001243201704_en.pdf"},
    {"id":"15866","name":"Presentation - “Phasing-in” issues in Marketing authorizations – Lithuanian perspectives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-phasing-issues-marketing-authorizations-lithuanian-perspectives_en.pdf"},
    {"id":"15868","name":"EU/3/02/109: Public summary of positive opinion for orphan designation of oregovomab for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2007-05-30T02:00:00Z","reference_number":"EMEA/COMP/1517/02 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302109-public-summary-positive-opinion-orphan-designation-oregovomab-treatment-ovarian-cancer_en.pdf"},
    {"id":"15871","name":"Presentation - What is new in terms of transparency (Kevin Cunningham)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T12:14:00Z","last_updated_date":"2017-03-30T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-new-terms-transparency-kevin-cunningham_en.pdf"},
    {"id":"15872","name":"10 years of the Orphan Regulation in Europe conference - The experience up to date: S. Aarum, S.Tsigkos","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/10-years-orphan-regulation-europe-conference-experience-date-s-aarum-stsigkos_en.pdf"},
    {"id":"15874","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  Cimzia","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-11-15T00:09:21Z","last_updated_date":"2007-11-15T00:09:21Z","reference_number":"EMEA/518720/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-cimzia_en.pdf"},
    {"id":"15875","name":"Methylphenidate Sandoz Article-29 referral - Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet, 18, 36 and 54 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    {"id":"15877","name":"Presentation - The risk of asthma therapy as assessed from real-life data ASTRO-LAB & SNIIRAM (Eric van Ganse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-asthma-therapy-assessed-real-life-data-astro-lab-sniiram-eric-van-ganse_en.pdf"},
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    {"id":"15879","name":"European Medicines Agency welcomes continuation of D:A:D study","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-03T01:00:00Z","last_updated_date":"2009-02-03T01:00:00Z","reference_number":"EMEA/44937/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-welcomes-continuation-dad-study_en.pdf"},
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    {"id":"15911","name":"Protherics withdraws its marketing authorisation application for Voraxaze","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:09:21Z","last_updated_date":"2009-05-29T02:09:21Z","reference_number":"EMEA/235491/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/protherics-withdraws-its-marketing-authorisation-application-voraxaze_en.pdf"},
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    {"id":"15914","name":"Polymyxin Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-05T01:00:00Z","last_updated_date":"2015-01-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/polymyxin-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/polymyxin-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/polymyxin-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/polymyxin-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/polymyxin-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/polymyxin-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/polymyxin-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/polymyxin-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/polymyxin-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/polymyxin-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/polymyxin-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/polymyxin-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/polymyxin-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/polymyxin-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/polymyxin-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/polymyxin-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/polymyxin-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/polymyxin-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/polymyxin-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/polymyxin-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/polymyxin-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/polymyxin-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/polymyxin-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"15915","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Ecazide and associated names International Non-Proprietary Name (INN): captopril/hydrochlorothiazid...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-09-19T02:08:21Z","last_updated_date":"2002-09-19T02:08:21Z","reference_number":"EMEA/CPMP/4717/02/en/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-ecazide-and-associated-names-international-non-proprietary-name-inn_en.pdf"},
    {"id":"15919","name":"Adrenaline auto-injectors Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/adrenaline-auto-injectors-article-31-referral-notification_en.pdf"},
    {"id":"15920","name":"Superseded overview of comments received on ‘Community herbal monograph on Passiflora incarnate L., herba’ (EMEA/HMPC/230962/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-11-15T00:09:21Z","last_updated_date":"2014-06-19T01:09:21Z","reference_number":"EMEA/HMPC/383450/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-passiflora-incarnate-l-herba-emeahmpc2309622006_en.pdf"},
    {"id":"15921","name":"Opinion following an Article 29(2) referral for Lansoprazol CT-Arzneimittel 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-02-22T00:08:21Z","last_updated_date":"2006-02-22T00:08:21Z","reference_number":"EMEA/CHMP/373108/2005","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-292-referral-lansoprazol-ct-arzneimittel-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sv.pdf"}},
    {"id":"15922","name":"Isotretinoin - Article 29 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/isotretinoin-article-29-referral-assessment-report_en.pdf"},
    {"id":"15924","name":"Final assessment report on Uncaria tomentosa (Willd. ex Schult.) DC., cortex","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMA/HMPC/259598/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-uncaria-tomentosa-willd-ex-schult-dc-cortex_en.pdf"},
    {"id":"15925","name":"PART II: The Innovative Medicines Initiative; EMEA Viewpoint on the Innovative Medicines Initiative - Stimulating research and innovation - Marisa Papaluca-Amati","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/part-ii-innovative-medicines-initiative-emea-viewpoint-innovative-medicines-initiative-stimulating-research-and-innovation-marisa-papaluca-amati_en.pdf"},
    {"id":"15927","name":"Presentation - Update from SME office, Ms Melanie Carr","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-sme-office-ms-melanie-carr_en.pdf"},
    {"id":"15931","name":"EU/3/01/042: Public summary of positive opinion for orphan designation\n\nof human engineered monoclonal antibody specific for transforming growth factor β2 (CAT-152) for the prevention of scarring in glaucoma filtration ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-05-05T02:00:00Z","reference_number":"EMEA/COMP/220/04draft Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301042-public-summary-positive-opinion-orphan-designation-human-engineered-monoclonal-antibody-specific-transforming-growth-factor-i22-cat-152-prevention-scarring-glaucoma-filtration_en.pdf"},
    {"id":"15932","name":"Questions and answers on the referral for Priligy","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-10-21T02:00:00Z","last_updated_date":"2012-03-28T02:00:00Z","reference_number":"EMA/CHMP/842278/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-priligy_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-priligy_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-priligy_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-priligy_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-priligy_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-priligy_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-priligy_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-priligy_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-priligy_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-priligy_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-priligy_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-priligy_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-priligy_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-priligy_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-priligy_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-priligy_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-priligy_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-priligy_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-priligy_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-priligy_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-priligy_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-priligy_sv.pdf"}},
    {"id":"15933","name":"Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-02-28T18:30:00Z","last_updated_date":"2014-02-28T18:30:00Z","reference_number":"EMA/CHMP/BWP/814397/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-porcine-trypsin-used-manufacture-human-biological-medicinal-products_en.pdf"},
    {"id":"15934","name":"CHMP post-authorisation summary of positive opinion for Docetaxel Winthrop","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2022-05-20T01:00:00Z","reference_number":"EMEA/CHMP/752754/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-docetaxel-winthrop_en.pdf"},
    {"id":"15936","name":"Presentation - Encouraging paediatric clinical research in the European Union (Benjamin Pelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-encouraging-paediatric-clinical-research-european-union-benjamin-pelle_en.pdf"},
    {"id":"15937","name":"Performance indicators for the EMEA in 2003","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-04-16T02:00:00Z","last_updated_date":"2004-04-16T02:00:00Z","reference_number":"EMEA/5217/04, rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/performance-indicators-emea-2003_en.pdf"},
    {"id":"15938","name":"Letter of support for skeletal muscle injury biomarkers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-19T14:00:00Z","last_updated_date":"2015-03-19T14:00:00Z","reference_number":"EMA/116308/2015","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-skeletal-muscle-injury-biomarkers_en.pdf"},
    {"id":"15940","name":"Committee for medicinal products for human use, summary of positive opinion for  RoActemra","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"EMEA/CHMP/580914/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-roactemra_en.pdf"},
    {"id":"15942","name":"Agenda - EU Regulatory Network - Challenges and Opportunities for Croatia","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eu-regulatory-network-challenges-and-opportunities-croatia_en.pdf"},
    {"id":"15943","name":"Presentation - Trial of ESVAC protocol for per-species consumption in pigs (Marian Bos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T17:00:00Z","last_updated_date":"2016-03-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-trial-esvac-protocol-species-consumption-pigs-marian-bos_en.pdf"},
    {"id":"15944","name":"Guideline on medicinal products for the treatment of insomnia - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-02-26T00:31:00Z","last_updated_date":"2011-02-26T00:31:00Z","reference_number":"EMA/CHMP/16274/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-medicinal-products-treatment-insomnia-revision-1_en.pdf"},
    {"id":"15945","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 December 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-13T17:00:00Z","last_updated_date":"2013-12-13T17:00:00Z","reference_number":"EMA/CVMP/735977/20132013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-december-2013_en.pdf"},
    {"id":"15947","name":"EU/3/17/1937: Public summary of opinion on orphan designation: 4-Amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl)cyclopent-2-en-1-yl]pyrimidin-2-one for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/689758/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171937-public-summary-opinion-orphan-designation-4-amino-1-1s4r5s-2-fluoro-45-dihydroxy-3-hydroxymethylcyclopent-2-en-1-ylpyrimidin-2-one-treatment-pancreatic-cancer_en.pdf"},
    {"id":"15948","name":"Tosylchloramide sodium: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-02-01T01:00:00Z","last_updated_date":"1999-02-01T01:00:00Z","reference_number":"EMEA/MRL/570/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tosylchloramide-sodium-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"15950","name":"Break-out session 2 report - Modelling and simulation in clinical pharmacology and dose finding","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-05-08T11:30:00Z","last_updated_date":"2012-05-08T11:30:00Z","reference_number":"EMA/143475/2012","document_url":"https://www.ema.europa.eu/en/documents/report/break-out-session-2-report-modelling-and-simulation-clinical-pharmacology-and-dose-finding_en.pdf"},
    {"id":"15953","name":"EU/3/08/558: Public summary of positive opinion for orphan designation of sapacitabine for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/369006/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308558-public-summary-positive-opinion-orphan-designation-sapacitabine-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"15958","name":"Opinions on safety variations / periodic safety update reports adopted during the CHMP meeting 22-25 September 2014","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2014-10-13T16:00:00Z","last_updated_date":"2014-10-13T16:00:00Z","reference_number":"EMA/129677/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variations-periodic-safety-update-reports-adopted-during-chmp-meeting-22-25-september-2014_en.pdf"},
    {"id":"15959","name":"Position paper on the risks associated with the use of herbal products containing Aristolochia species","type":"position","status":"unknown","consultation_date":"","first_published_date":"2000-10-31T00:09:21Z","last_updated_date":"2000-10-31T00:09:21Z","reference_number":"EMEA/HMPWP/23/00","document_url":"https://www.ema.europa.eu/en/documents/position/position-paper-risks-associated-use-herbal-products-containing-aristolochia-species_en.pdf"},
    {"id":"15960","name":"Final assessment report on Paeonia lactiflora Pall. and/or Paeonia veitchii Lynch, radix (Paeoniae radix rubra)","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2017-04-25T17:35:00Z","last_updated_date":"2017-04-28T12:47:00Z","reference_number":"EMA/HHMP/762953/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-paeonia-lactiflora-pall-andor-paeonia-veitchii-lynch-radix-paeoniae-radix-rubra_en.pdf"},
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    {"id":"16043","name":"Question and answers on the CVMP guideline on testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats (EMEA/CVMP/005/00-Rev 2)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2012-07-25T12:00:00Z","reference_number":"EMEA/CVMP/EWP/82829/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/question-and-answers-cvmp-guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestations-dogs-and-cats-emeacvmp00500-rev-2_en.pdf"},
    {"id":"16045","name":"Ex ante publicity of a negotiated procedure – EMA/2016/60/COM – Pharmaceutical eBooks","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-09-15T14:00:00Z","last_updated_date":"2016-09-15T14:00:00Z","reference_number":"EMA/473661/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201660com-pharmaceutical-ebooks_en.pdf"},
    {"id":"16047","name":"Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-08-14T13:00:00Z","last_updated_date":"2022-11-22T14:43:00Z","reference_number":"EMA/HMPC/124695/2011 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/procedure-review-and-revision-european-union-herbal-monographs-and-european-union-list-entries-revision-3_en.pdf"},
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    {"id":"16049","name":"CHMP post-authorisation summary of positive opinion for Zytiga","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2012-11-16T01:00:00Z","reference_number":"EMA/CHMP/697344/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zytiga_en.pdf"},
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    {"id":"16052","name":"Public Status Report on the Implementation of the European Risk Management Strategy (Reporting Period Mid 2005 – Mid 2007)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-07-26T02:09:21Z","last_updated_date":"2007-07-26T02:09:21Z","reference_number":"EMEA/168954/2007","document_url":"https://www.ema.europa.eu/en/documents/other/public-status-report-implementation-european-risk-management-strategy-reporting-period-mid-2005-mid-2007_en.pdf"},
    {"id":"16053","name":"Declaration of research interests (addendum) - Wolfgang Gopel","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-research-interests-addendum-wolfgang-gopel_en.pdf"},
    {"id":"16054","name":"Committee for medicinal products for veterinary use: Meeting of 13-15 February 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-02-19T12:09:21Z","last_updated_date":"2007-02-19T12:09:21Z","reference_number":"EMEA/CVMP/49306/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-13-15-february-2007_en.pdf"},
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    {"id":"16099","name":"Trends in the sales of veterinary antimicrobial agents in nine European countries","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-09-19T13:30:00Z","last_updated_date":"2011-09-19T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/trends-sales-veterinary-antimicrobial-agents-nine-european-countries_en.pdf"},
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    {"id":"16101","name":"Ergot derivatives Article-31 referral - Dihydroergocristine - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-iii_sv.pdf"}},
    {"id":"16102","name":"2003 European Commission guideline on 'Excipients in the label and package leaflet of medicinal products for human use'","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-03-01T14:10:00Z","last_updated_date":"2018-03-01T14:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/2003-european-commission-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"16103","name":"Draft points to consider on the evidence of safety and efficacy required for well-established Herbal Medicinal Products in bibliographic applications","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"1999-10-25T02:00:00Z","last_updated_date":"1999-10-25T02:00:00Z","reference_number":"EMEA/HMPWP/23/99","document_url":"https://www.ema.europa.eu/en/documents/other/draft-points-consider-evidence-safety-and-efficacy-required-well-established-herbal-medicinal-products-bibliographic-applications_en.pdf"},
    {"id":"16108","name":"EU/3/03/137: Public summary of positive opinion for orphan designation of tositumomab for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2015-05-09T01:00:00Z","reference_number":"EMEA/COMP/4/2003 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303137-public-summary-positive-opinion-orphan-designation-tositumomab-treatment-follicular-lymphoma_en.pdf"},
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    {"id":"16113","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 February 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T10:40:00Z","last_updated_date":"2017-03-09T10:40:00Z","reference_number":"EMA/PDCO/140294/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-21-24-february-2017_en.pdf"},
    {"id":"16115","name":"Concept paper on the need for revision of the guideline on clinical investigation of hypnotic medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/CHMP/EWP/310566/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-hypnotic-medicinal-products_en.pdf"},
    {"id":"16116","name":"Technical specification - Annex 3 Lot 2 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-3-lot-2-external-service-providers-software-applications-ema201213ict_en.xls"},
    {"id":"16118","name":"Sandostatin - Article 30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T14:00:00Z","last_updated_date":"2014-07-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sandostatin-article-30-referral-annex-iii_en.pdf"},
    {"id":"16119","name":"Presentation - Topic 3 - Views of networks: trial preparedness - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-3-views-networks-trial-preparedness-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation_en.pdf"},
    {"id":"16120","name":"Concept paper on the revision of the note for guidance on radiopharmaceuticals","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-03-30T02:00:00Z","last_updated_date":"2006-03-30T02:00:00Z","reference_number":"EMEA/CHMP/92877/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-radiopharmaceuticals_en.pdf"},
    {"id":"16121","name":"Infringement procedure against Roche – EMA update","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-04T02:00:00Z","last_updated_date":"2016-07-04T02:00:00Z","reference_number":"EMA/453738/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/infringement-procedure-against-roche-ema-update_en.pdf"},
    {"id":"16122","name":"Pholcodine - Article 31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-03-28T02:00:00Z","last_updated_date":"2012-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-article-31-referral-assessment-report_en.pdf"},
    {"id":"16124","name":"Numeta Article-107i procedure - PRAC recommends suspension and reformulation for Numeta G13%E and risk minimisation measures for Numeta G16%E","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-06T02:00:00Z","last_updated_date":"2013-09-06T02:00:00Z","reference_number":"EMA/531101/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-prac-recommends-suspension-and-reformulation-numeta-g13e-and-risk-minimisation-measures-numeta-g16e_en.pdf"},
    {"id":"16125","name":"Questions and answers on propylene glycol used as an excipient in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/704195/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-propylene-glycol-used-excipient-medicinal-products-human-use_en.pdf"},
    {"id":"16126","name":"EU/3/15/1454: Public summary of positive opinion for orphan designation of 6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-benzoxazin-4-one for the treatment of Netherton syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/116731/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151454-public-summary-positive-opinion-orphan-designation-6-ethoxy-7-methoxy-2-2-methylsulfanylphenyl-31-benzoxazin-4-one-treatment-netherton-syndrome_en.pdf"},
    {"id":"16127","name":"EU/3/13/1117: Public summary of opinion on orphan designation:\n\nRamiprilat for the treatment of Stargardt’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-05T02:00:00Z","last_updated_date":"2013-04-05T02:00:00Z","reference_number":"EMA/COMP/92888/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131117-public-summary-opinion-orphan-designation-ramiprilat-treatment-stargardts-disease_en.pdf"},
    {"id":"16128","name":"EU/3/06/385: Public summary of positive opinion for orphan designation\n\nof 2-(4-(diethylamino) phenyl)-6-methyl-2H-benzo[d][1,2,3] triazol-5-amine\n\nfor the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/176490/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306385-public-summary-positive-opinion-orphan-designation-2-4-diethylamino-phenyl-6-methyl-2h-benzod123-triazol-5-amine-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"16130","name":"Hearing with interested parties during Working Party on Community Monographs and Community List July 2006 meeting","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-05-22T16:00:00Z","last_updated_date":"2013-05-22T16:00:00Z","reference_number":"EMEA/HMPC/222795/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-interested-parties-during-working-party-community-monographs-and-community-list-july-2006-meeting_en.pdf"},
    {"id":"16132","name":"Assessment report pursuant to Article 30 of Directive 2001/83/EC - Kytril and associated names","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-09-12T02:00:00Z","last_updated_date":"2011-09-12T02:00:00Z","reference_number":"EMA/708931/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-pursuant-article-30-directive-200183ec-kytril-and-associated-names_en.pdf"},
    {"id":"16134","name":"Overview of comments received on VICH guideline on statistical evaluation of stability data (GL 51)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-05-29T12:30:00Z","last_updated_date":"2015-05-29T12:30:00Z","reference_number":"VICH GL-51","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-vich-guideline-statistical-evaluation-stability-data-gl-51_en.pdf"},
    {"id":"16135","name":"Public Statement on Thiomersal containing medicinal products","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-07-08T02:00:00Z","last_updated_date":"1999-07-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-thiomersal-containing-medicinal-products_en.pdf"},
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    {"id":"16197","name":"EU/3/14/1382: Public summary of positive opinion for orphan designation:  Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2022-09-16T18:00:00Z","reference_number":"EMA/COMP/724271/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141382-public-summary-positive-opinion-orphan-designation-allogeneic-cd34-cells-expanded-ex-vivo-aryl-hydrocarbon-receptor-antagonist-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"16198","name":"EU/3/10/777: Public summary of opinion on orphan designation: Cyclic pyranopterin monophosphate for the treatment of molybdenum-cofactor deficiency type A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2015-03-25T12:15:00Z","reference_number":"EMA/COMP/403557/2010 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310777-public-summary-opinion-orphan-designation-cyclic-pyranopterin-monophosphate-treatment-molybdenum-cofactor-deficiency-type_en.pdf"},
    {"id":"16202","name":"Presentation - Closing remarks on the workshop on process validation (Kowid Ho)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-closing-remarks-workshop-process-validation-kowid-ho_en.pdf"},
    {"id":"16203","name":"Opinion following an Article 35  referral for Dexadreson 2 mg/ml and associated names, and generic products thereof","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-27T01:00:00Z","last_updated_date":"2013-11-27T01:00:00Z","reference_number":"EMA/539466/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-35-referral-dexadreson-2-mgml-and-associated-names-and-generic-products-thereof_sv.pdf"}},
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    {"id":"16205","name":"Harunga madagascariensis: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/598/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/harunga-madagascariensis-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"16211","name":"Committee for Orphan Medicinal Products: September 2006 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-09-07T02:00:00Z","last_updated_date":"2006-09-07T02:00:00Z","reference_number":"EMEA/COMP/357633/2006/Revised","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-september-2006-meeting_en.pdf"},
    {"id":"16212","name":"Final community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-06-20T02:00:00Z","reference_number":"EMA/HMPC/587578/200","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-tanacetum-parthenium-l-schulz-bip-herba_en.pdf"},
    {"id":"16215","name":"European Medicines Agency update on the safety of Tamiflu","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"EMEA/385013/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-update-safety-tamiflu_en.pdf"},
    {"id":"16222","name":"European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/652837/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-finalises-review-medicines-concerned-roche-pharmacovigilance-inspection_en.pdf"},
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    {"id":"16227","name":"Appeal procedure for Orphan Medicinal Product designation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-02-09T00:00:00Z","last_updated_date":"2001-02-09T00:00:00Z","reference_number":"EMEA/COMP/50/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/appeal-procedure-orphan-medicinal-product-designation_en.pdf"},
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    {"id":"16230","name":"Presentation - Interface Enpr-EMA and ENCePP (Kevin Blake)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interface-enpr-ema-and-encepp-kevin-blake_en.pdf"},
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    {"id":"16241","name":"Overview of comments received on draft guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C (EMEA/CHMP/EWP/30039/2008)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/EWP/144962/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-evaluation-direct-acting-antiviral-agents-intended-treatment-chronic-hepatitis-c-emeachmpewp300392008_en.pdf"},
    {"id":"16242","name":"Two irradiated allogeneic pancreatic tumour cell lines, genetically engineered to secrete human granulocyte macrophage-colony stimulating factor (GM-CSF)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2016-05-04T13:00:00Z","reference_number":"EMA/291905/2016","document_url":"https://www.ema.europa.eu/en/documents/report/two-irradiated-allogeneic-pancreatic-tumour-cell-lines-genetically-engineered-secrete-human-granulocyte-macrophage-colony-stimulating-factor-gm-csf_en.pdf"},
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    {"id":"16246","name":"EU/3/14/1338: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene for the treatment of Crigler-Najjar syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/558518/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141338-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-ugt1a1-gene-treatment-crigler-najjar-syndrome_en.pdf"},
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    {"id":"16248","name":"Guideline on quality of herbal medicinal products traditional herbal medicinal products - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-09-28T12:55:00Z","last_updated_date":"2011-09-28T12:55:00Z","reference_number":"EMA/HMPC/201116/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-2_en.pdf"},
    {"id":"16249","name":"EU/3/16/1648: Public summary of opinion on orphan designation: Human/murine chimeric monoclonal antibody against endoglin for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/247747/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161648-public-summary-opinion-orphan-designation-humanmurine-chimeric-monoclonal-antibody-against-endoglin-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"16253","name":"European Medicines Agency / Food and Drug Administration joint good-manufacturing-practice-inspection pilot programme - General principles","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-11-15T01:00:00Z","last_updated_date":"2010-11-15T01:00:00Z","reference_number":"EMA/660312/2010","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-food-and-drug-administration-joint-good-manufacturing-practice-inspection-pilot-programme-general-principles_en.pdf"},
    {"id":"16254","name":"Public statement on Hexavac: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-08-16T02:00:00Z","last_updated_date":"2012-08-16T02:00:00Z","reference_number":"EMA/273279/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-hexavac-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"16257","name":"Gelatin for use in pharmaceuticals: explanatory note (13 december 2000) on the manufacture of gelatin in relationship to the CPMP note For guidance on minimising the risk of transmitting Animal Spongiform Encephalopathy ...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-12-13T01:00:00Z","last_updated_date":"2000-12-13T01:00:00Z","reference_number":"EMEA/CPMP/4306/00/v 0.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/gelatin-use-pharmaceuticals-explanatory-note-13-december-2000-manufacture-gelatin-relationship-cpmp-note-guidance-minimising-risk-transmitting-animal-spongiform-encephalopathy_en.pdf"},
    {"id":"16259","name":"Domperidone Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2014-09-11T10:55:00Z","reference_number":"EMA/147415/2013 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/referral/domperidone-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/domperidone-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/domperidone-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/domperidone-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/domperidone-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/domperidone-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/domperidone-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/domperidone-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/domperidone-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/domperidone-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/domperidone-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/domperidone-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/domperidone-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/domperidone-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/domperidone-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/domperidone-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/domperidone-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/domperidone-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/domperidone-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/domperidone-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/domperidone-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/domperidone-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/domperidone-article-31-referral-annex-i_sv.pdf"}},
    {"id":"16260","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Effentora (fentanyl)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/447220/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-effentora-fentanyl_sv.pdf"}},
    {"id":"16261","name":"Agenda - EMA - Spinal muscular atrophy workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-11-07T10:50:00Z","last_updated_date":"2016-11-07T10:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-spinal-muscular-atrophy-workshop_en.pdf"},
    {"id":"16262","name":"Agenda - Second industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-14T17:57:00Z","last_updated_date":"2017-11-14T17:57:00Z","reference_number":"EMA/630645/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"16263","name":"EU/3/01/044: Public summary of positive opinion for orphan designation of human alpha1-proteinase inhibitor (respiratory use) for the treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T00:00:00Z","last_updated_date":"2011-05-06T01:00:00Z","reference_number":"EMEA/COMP/221/04draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301044-public-summary-positive-opinion-orphan-designation-human-alpha1-proteinase-inhibitor-respiratory-use-treatment-emphysema-secondary-congenital-alpha-1-antitrypsin-deficiency_en.pdf"},
    {"id":"16264","name":"Withdrawal assessment report for Surfaxin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2006-07-26T02:00:00Z","last_updated_date":"2006-07-26T02:00:00Z","reference_number":"EMEA/CHMP/255780/2006","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-surfaxin_en.pdf"},
    {"id":"16265","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Bronchitol (mannitol) for the treatment of cystic fibrosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-10-30T16:23:00Z","last_updated_date":"2012-10-30T16:23:00Z","reference_number":"EMA/COMP/874717/2011  ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-bronchitol-mannitol-treatment-cystic-fibrosis_en.pdf"},
    {"id":"16268","name":"Enalapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00001212/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-16T12:32:00Z","last_updated_date":"2018-03-16T12:35:54Z","reference_number":"EMA/170163/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/enalapril-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00001212201707_en.pdf"},
    {"id":"16270","name":"Questions and answers on the withdrawal of the marketing authorisation application for Ratioepo (epoetin theta)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/146533/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ratioepo-epoetin-theta_en.pdf"},
    {"id":"16271","name":"Codeine Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T02:00:00Z","last_updated_date":"2015-05-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"16275","name":"Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with launch of public consultation of module VI revision 1 and module XVI","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"EMA/321625/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-introductory-cover-note-last-updated-launch-public-consultation-module-vi-revision-1-and-module-xvi_en.pdf"},
    {"id":"16276","name":"A joint meeting between TOPRA and the European Medicines Agency - Overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-10-23T02:09:21Z","last_updated_date":"2009-10-23T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joint-meeting-between-topra-and-european-medicines-agency-overview_en.pdf"},
    {"id":"16277","name":"Presentation - Session 3.7: EMA framework of collaboration with academia (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-37-ema-framework-collaboration-academia-isabelle-moulon_en.pdf"},
    {"id":"16278","name":"Overview of comments received on ' Guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS)' (EMA/531686/2015)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T16:25:00Z","last_updated_date":"2016-02-01T16:25:00Z","reference_number":"EMA/CHMP/131550/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-amyotrophic-lateral-sclerosis-als-ema5316862015_en.pdf"},
    {"id":"16279","name":"Agenda - Meeting with stakeholders on monitoring sales of veterinary antimicrobial agents in Europe","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-12-22T13:01:27Z","last_updated_date":"2010-12-22T13:01:27Z","reference_number":"EMA/271500/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-meeting-stakeholders-monitoring-sales-veterinary-antimicrobial-agents-europe_en.pdf"},
    {"id":"16281","name":"EU/3/12/973: Public summary of opinion on orphan designation: Recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-19T11:45:00Z","last_updated_date":"2015-05-27T11:45:00Z","reference_number":"EMA/COMP/73113/2012 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312973-public-summary-opinion-orphan-designation-recombinant-human-beta-glucuronidase-treatment-mucopolysaccharidosis-type-vii-sly-syndrome_en.pdf"},
    {"id":"16282","name":"Somatolsalm: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-02T01:00:00Z","last_updated_date":"1997-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/somatolsalm-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16283","name":"EU/3/17/1964: Public summary of opinion on orphan designation: Itacitinib for treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-13T01:00:00Z","last_updated_date":"2018-03-13T01:00:00Z","reference_number":"EMA/4237/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171964-public-summary-opinion-orphan-designation-itacitinib-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"16286","name":"Divergent position on a CVMP opinion on an Article 33(4) referral of Directive 2001/82/EC for Deltanil 10 mg/ml pour-on solution for cattle and sheep and Deltanil 100 mg spot-on solution for cattle","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-334-referral-directive-200182ec-deltanil-10-mgml-pour-solution-cattle-and-sheep-and-deltanil-100-mg-spot-solution-cattle_en.pdf"},
    {"id":"16287","name":"Request for confirmation of the applicability of the EMEA decision on class waivers","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"n/a","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-confirmation-applicability-emea-decision-class-waivers_en.doc"},
    {"id":"16288","name":"EU/3/12/949: Public summary of opinion on orphan designation: Sodium phenylbutyrate for the treatment of citrullinaemia type 1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2017-08-09T02:00:00Z","reference_number":"EMA/COMP/43229/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312949-public-summary-opinion-orphan-designation-sodium-phenylbutyrate-treatment-citrullinaemia-type-1_en.pdf"},
    {"id":"16289","name":"Presentation - Case study 2 - Validation efficiencies from quality by design (QbD) and prior knowledge - Session 3 (Frank Zettl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-2-validation-efficiencies-quality-design-qbd-and-prior-knowledge-session-3-frank-zettl_en.pdf"},
    {"id":"16290","name":"Presentation - The role of PSURS in pharmacovigilance inspections - Getting it right and practical experience (Ernesto Vera Sà¡nchez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-psurs-pharmacovigilance-inspections-getting-it-right-and-practical-experience-ernesto-vera-sanchez_en.pdf"},
    {"id":"16291","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the March 2010 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-03-05T01:00:00Z","last_updated_date":"2010-03-05T01:00:00Z","reference_number":"EMA/COMP/89960/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-march-2010-meeting_en.pdf"},
    {"id":"16294","name":"Protelos and Osseor Article-20 procedure: CHMP scientific conclusions and PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-02-28T16:30:00Z","last_updated_date":"2014-02-28T16:30:00Z","reference_number":"EMA/112925/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/protelos-and-osseor-article-20-procedure-chmp-scientific-conclusions-and-prac-assessment-report_en.pdf"},
    {"id":"16295","name":"Opinion of the HMPC on a European Union herbal monograph on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-07-07T02:00:00Z","reference_number":"EMA/HMPC/66094/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-cortex_en.pdf"},
    {"id":"16296","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Ravicti (glycerol phenylbutyrate) for the treatment of urea cycle disorders [carbamoyl phosphate-synthase-1 deficiency, ornithi...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-01-04T15:00:00Z","last_updated_date":"2016-01-04T15:00:00Z","reference_number":"EMA/COMP/658477/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-ravicti-glycerol-phenylbutyrate-treatment-urea-cycle-disorders-carbamoyl-phosphate-synthase-1-deficiency-ornithi_en.pdf"},
    {"id":"16298","name":"European Medicines Agency acts on deficiencies in Roche medicines-safety reporting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-21T18:00:05Z","last_updated_date":"2012-06-21T18:00:05Z","reference_number":"EMA/405725/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-acts-deficiencies-roche-medicines-safety-reporting_en.pdf"},
    {"id":"16299","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Hypnovel and associated names International Non-Proprietary Name (INN): midazolam: Background infor...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-09-16T02:08:21Z","last_updated_date":"2002-09-16T02:08:21Z","reference_number":"EMEA/CPMP/4620/02/en/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-hypnovel-and-associated-names-international-non-proprietary-name-inn-midazolam-background_en.pdf"},
    {"id":"16300","name":"Presentation - Variations and progress in worksharing (Melanie Leivers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-variations-and-progress-worksharing-melanie-leivers_en.pdf"},
    {"id":"16304","name":"EU/3/12/966: Public summary of opinion on orphan designation:\n\n(1-Methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophosphate for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-19T11:45:00Z","last_updated_date":"2016-10-21T12:00:00Z","reference_number":"EMA/COMP/67848/2012 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312966-public-summary-opinion-orphan-designation-1-methyl-2-nitro-1h-imidazole-5-ylmethyl-nn-bis2-bromoethyl-diamidophosphate-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"16305","name":"Start of Community reviews - CHMP meeting of 20-23 January 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T13:00:00Z","last_updated_date":"2014-01-24T13:00:00Z","reference_number":"EMA/39103/2014","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-20-23-january-2014_en.pdf"},
    {"id":"16306","name":"EU/3/06/377: Public summary of positive opinion for orphan designation of mecasermin rinfabate for the treatment of patients with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/309736/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306377-public-summary-positive-opinion-orphan-designation-mecasermin-rinfabate-treatment-patients-growth-hormone-gh-gene-deletion-who-have-developed-neutralizing-antibodies-gh_en.pdf"},
    {"id":"16308","name":"Download EPS - Species pictograms - Sheep","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-sheep_en.zip"},
    {"id":"16310","name":"Presentation - Federation of Veterinarians of Europe (Nancy De Briyne)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T13:00:00Z","last_updated_date":"2013-04-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-federation-veterinarians-europe-nancy-de-briyne_en.pdf"},
    {"id":"16311","name":"Presentation - Guidelines HAP/VAP: Standpoint from (some) academics (Serge Kouzan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidelines-hapvap-standpoint-some-academics-serge-kouzan_en.pdf"},
    {"id":"16312","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the December 2007 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-12-06T00:09:21Z","last_updated_date":"2007-12-06T00:09:21Z","reference_number":"EMEA/COMP/554248/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-december-2007-meeting_en.pdf"},
    {"id":"16313","name":"CHMP post-authorisation summary of positive opinion for Revolade","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/CHMP/371721/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revolade_en.pdf-0"},
    {"id":"16314","name":"Overview of comments on 'Points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations' (EMA/CHMP/778709/2015) - First version","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2018-02-22T17:30:00Z","last_updated_date":"2018-02-22T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-points-consider-frailty-evaluation-instruments-baseline-characterisation-clinical-trial-populations-emachmp7787092015-first-version_en.pdf"},
    {"id":"16315","name":"Superseded overview of comments received on  'Community herbal monograph on  Linum usitatissimum L., semen'  EMEA/HMPC/340849/2005","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2006-10-25T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMEA/HMPC/66042/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-linum-usitatissimum-l-semen-emeahmpc3408492005_en.pdf"},
    {"id":"16316","name":"Committee for Proprietary Medicinal Products (CPMP) 16th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-05-23T02:00:00Z","last_updated_date":"1996-05-23T02:00:00Z","reference_number":"CPMP/426/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-16th-plenary-meeting_en.pdf"},
    {"id":"16317","name":"EU/3/13/1167: Public summary of opinion on orphan designation: Heterologous human adult liver-derived progenitor cells for the treatment of ornithine-translocase deficiency (hyperornithinaemia-hyperammonaemia-homocitrull...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T17:30:00Z","last_updated_date":"2013-08-22T17:30:00Z","reference_number":"EMA/COMP/413224/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131167-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-progenitor-cells-treatment-ornithine-translocase-deficiency-hyperornithinaemia-hyperammonaemia-homocitrull_en.pdf"},
    {"id":"16320","name":"Ribavirin (aerosol application): List of nationally authorised medicinal products - PSUSA/00010003/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T12:00:00Z","last_updated_date":"2016-10-17T19:46:17Z","reference_number":"EMA/268896/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ribavirin-aerosol-application-list-nationally-authorised-medicinal-products-psusa00010003201508_en.pdf"},
    {"id":"16324","name":"EU/3/05/327: Public summary of positive opinion for orphan designation of oligonucleotide phosphorothioate (TAAACGTTATAACGTTATGACGTCAT), sodium salt for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T00:00:00Z","last_updated_date":"2006-01-04T00:00:00Z","reference_number":"EMEA/COMP/317431/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305327-public-summary-positive-opinion-orphan-designation-oligonucleotide-phosphorothioate-taaacgttataacgttatgacgtcat-sodium-salt-treatment-glioma_en.pdf"},
    {"id":"16327","name":"Final community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-28T01:00:00Z","last_updated_date":"2020-04-08T01:00:00Z","reference_number":"EMA/HMPC/212895/2008 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf"},
    {"id":"16328","name":"Opinions on annual reassessments, 5-year renewals adopted at the CHMP meeting of 16-19 January 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-26T16:12:00Z","last_updated_date":"2012-01-26T16:12:00Z","reference_number":"EMA/CHMP/8919/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-reassessments-5-year-renewals-adopted-chmp-meeting-16-19-january-2012_en.pdf"},
    {"id":"16331","name":"Overview of comments received by EMA on 'Questions and answers - ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - Step 2b'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-02-13T01:00:00Z","last_updated_date":"2017-02-13T01:00:00Z","reference_number":"EMA/72007/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ema-questions-and-answers-ich-s9-guideline-nonclinical-evaluation-anticancer-pharmaceuticals-step-2b_en.pdf"},
    {"id":"16332","name":"CHMP summary of positive opinion for Keytruda","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/298313/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-keytruda_en.pdf"},
    {"id":"16333","name":"Mandate, objectives and rules of procedure for the CVMP Safety Working Party (SWP-V)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2007-12-12T00:09:00Z","last_updated_date":"2021-04-07T09:14:00Z","reference_number":"EMA/CVMP/SWP/131613/2004 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-cvmp-safety-working-party-swp-v_en.pdf"},
    {"id":"16334","name":"Withdrawal assessment report for Qutenza","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T14:25:00Z","last_updated_date":"2012-04-20T14:25:00Z","reference_number":"EMA/252892/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-qutenza_en.pdf"},
    {"id":"16335","name":"Committee for Proprietary Medicinal Products (CPMP) 65th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-11-21T01:00:00Z","last_updated_date":"2000-11-21T01:00:00Z","reference_number":"CPMP/2901/00 corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-65th-plenary-meeting_en.pdf"},
    {"id":"16336","name":"EU/3/13/1133: Public summary of opinion on orphan designation: Maribavir for the treatment of cytomegalovirus disease in patients with impaired cell mediated immunity","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-06-25T19:00:00Z","reference_number":"EMA/COMP/258956/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131133-public-summary-opinion-orphan-designation-maribavir-treatment-cytomegalovirus-disease-patients-impaired-cell-mediated-immunity_en.pdf"},
    {"id":"16339","name":"Alarelin (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2018-01-31T18:00:00Z","last_updated_date":"2018-01-31T18:00:00Z","reference_number":"EMA/CVMP/156095/2017","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/alarelin-all-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"16340","name":"Second EMEA Workshop on Neurodegenerative Diseases, 'Focus on Dementia' -Brief Report & Presentations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-03-05T00:09:21Z","last_updated_date":"2008-03-05T00:09:21Z","reference_number":"EMEA/87024/2008","document_url":"https://www.ema.europa.eu/en/documents/report/second-emea-workshop-neurodegenerative-diseases-focus-dementia-brief-report-presentations_en.pdf"},
    {"id":"16341","name":"Presentation - Biosimilar industry perspective on draft guideline on immunogenicity assessment of monoclonal antibodies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:53Z","last_updated_date":"2012-06-15T17:10:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-biosimilar-industry-perspective-draft-guideline-immunogenicity-assessment-monoclonal-antibodies_en.pdf"},
    {"id":"16342","name":"CHMP summary of positive opinion for Sivextro","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2015-01-23T01:00:00Z","reference_number":"EMA/CHMP/46218/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sivextro_en.pdf"},
    {"id":"16343","name":"Working arrangement between the European Medicines Agency and the European Monitoring Centre for Drugs and Drug Addiction","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-14T02:00:00Z","last_updated_date":"2018-12-19T10:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/working-arrangement-between-european-medicines-agency-and-european-monitoring-centre-drugs-and-drug-addiction_en.pdf"},
    {"id":"16344","name":"Erythromycin / isotretinoin: List of nationally authorised medicinal products - PSUSA/00001796/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-27T02:00:00Z","last_updated_date":"2016-10-18T13:42:00Z","reference_number":"EMA/648919/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/erythromycin-isotretinoin-list-nationally-authorised-medicinal-products-psusa00001796201508_en.pdf"},
    {"id":"16346","name":"Chapter 6: Definitions of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-01T21:19:00Z","last_updated_date":"2012-09-24T11:18:00Z","reference_number":"EMA/720203/2011","document_url":"https://www.ema.europa.eu/en/documents/other/chapter-6-definitions-detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf"},
    {"id":"16348","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-11-28T11:40:00Z","last_updated_date":"2014-11-28T11:40:00Z","reference_number":"EMA/CAT/718445/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-november-2014-meeting_en.pdf"},
    {"id":"16349","name":"EU/3/10/759: Public summary of opinion on orphan designation: Pomalidomide for the treatment of post-essential thrombocythaemia myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-06T02:00:00Z","last_updated_date":"2017-02-10T12:39:00Z","reference_number":"EMA/COMP/249478/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310759-public-summary-opinion-orphan-designation-pomalidomide-treatment-post-essential-thrombocythaemia-myelofibrosis_en.pdf"},
    {"id":"16353","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Information session on...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T01:00:00Z","last_updated_date":"2015-06-04T13:00:00Z","reference_number":"EMA/59760/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-information_en.pdf"},
    {"id":"16354","name":"Inhaled corticosteroids Article-31 referral – Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-07-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/inhaled-corticosteroids-article-31-referral-annex-iii_no.pdf"}},
    {"id":"16356","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human glial-restricted precursors","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-25T18:00:00Z","last_updated_date":"2017-10-25T18:00:00Z","reference_number":"EMA/664971/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-human-glial-restricted-precursors_en.pdf"},
    {"id":"16357","name":"EU/3/07/443: Public summary of positive opinion for orphan designation of elafin for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2008-07-02T02:00:00Z","reference_number":"EMEA/COMP/570727/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307443-public-summary-positive-opinion-orphan-designation-elafin-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"16358","name":"CVMP summary of positive opinion for Recocam","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"EMA/CVMP/534720/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-recocam_en.pdf"},
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    {"id":"16381","name":"EU/3/12/1087: Public summary of opinion on orphan designation: Recombinant modified human growth hormone for the treatment of growth-hormone deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/810031/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121087-public-summary-opinion-orphan-designation-recombinant-modified-human-growth-hormone-treatment-growth-hormone-deficiency_en.pdf"},
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    {"id":"16405","name":"Linoladiol N and Linoladiol HN Article-31 referral - European Medicines Agency recommends restricting use of estradiol-containing creams Linoladiol N and Linoladiol HN","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T13:00:00Z","last_updated_date":"2014-04-25T14:00:00Z","reference_number":"EMA/796289/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-european-medicines-agency-recommends-restricting-use-estradiol-containing-creams-linoladiol-n-and-linoladiol-hn_en.pdf"},
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    {"id":"16407","name":"Scientific recommendation on classification of advanced therapy medicinal products: Sterile suspension of autologous cells of stromal vascular fraction of adipose tissue in Lactated Ringers solution","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T12:45:00Z","last_updated_date":"2016-04-12T12:45:00Z","reference_number":"EMA/213726/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-sterile-suspension-autologous-cells-stromal-vascular-fraction-adipose-tissue-lactated-ringers-solution_en.pdf"},
    {"id":"16409","name":"Presentation - Patient expectations for meaningful engagement in ERN-related clinical research (Russell Wheeler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-expectations-meaningful-engagement-ern-related-clinical-research-russell-wheeler_en.pdf"},
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    {"id":"16416","name":"Hydroxyethyl starch Article-107i procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-prac-list-questions_en.pdf"},
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    {"id":"16426","name":"Rabies vaccine : List of nationally authorised medicinal products: PSUSA/00009277/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T13:22:00Z","last_updated_date":"2016-12-19T13:24:54Z","reference_number":"EMA/865270/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabies-vaccine-list-nationally-authorised-medicinal-products-psusa00009277201603_en.pdf"},
    {"id":"16430","name":"Focus group meeting of CVMP experts, interested parties and member states - reflection paper on the use of fluoroquinolones in food-producing animals","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-11-01T00:09:21Z","last_updated_date":"2006-11-01T00:09:21Z","reference_number":"EMEA/425047/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/focus-group-meeting-cvmp-experts-interested-parties-and-member-states-reflection-paper-use-fluoroquinolones-food-producing-animals_en.pdf"},
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    {"id":"16434","name":"Public summary of the evaluation of a proposed product-specific\n\nwaiver: Abaloparatide for treatment of osteoporosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T12:30:00Z","last_updated_date":"2015-02-17T12:30:00Z","reference_number":"EMA/2396/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-abaloparatide-treatment-osteoporosis_en.pdf"},
    {"id":"16435","name":"Opinion of the HMPC on a Community herbal monograph on Paullina cupana Kunth ex H.G.K. var sorbilis (Mart.) Ducke, semen - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/2603/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-paullina-cupana-kunth-ex-hgk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
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    {"id":"16437","name":"Superseded - Final Community herbal monograph on Aloe barbadensis Miller and on Aloe (various species, mainly Aloe ferox Miller and its hybrids)","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2006-10-26T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMEA/HMPC/76310/2006 Corrigendum","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-aloe-barbadensis-miller-and-aloe-various-species-mainly-aloe-ferox-miller-and-its-hybrids_en.pdf"},
    {"id":"16438","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-16T01:00:00Z","last_updated_date":"2018-02-16T01:00:00Z","reference_number":"EMA/CVMP/64908/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-february-2018_en.pdf"},
    {"id":"16439","name":"EU/3/15/1580: Public summary of opinion on orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide for treatment of neuroblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/COMP/698281/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151580-public-summary-opinion-orphan-designation-n-5-35-difluorobenzyl-1h-indazol-3-yl-4-4-methylpiperazin-1-yl-2-tetrahydro-2h-pyran-4-ylaminobenzamide-treatment-neuroblastoma_en.pdf"},
    {"id":"16443","name":"Opinion of the Committee for proprietary medicinal products pursuant to Article 10 of Council Directive 75/319/EEC as amended, for Fluoxetin NM","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-06-10T02:08:21Z","last_updated_date":"1998-06-10T02:08:21Z","reference_number":"EMEA/H/A/200","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-10-council-directive-75319eec-amended-fluoxetin-nm_en.pdf"},
    {"id":"16447","name":"Clenbuterol hydrochloride: Summary report  (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/030/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/clenbuterol-hydrochloride-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16448","name":"Linoladiol N and Linoladiol HN Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-11T02:00:00Z","last_updated_date":"2014-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"16449","name":"EU/3/11/863: Public summary of opinion on orphan designation: Recombinant fusion protein linking human coagulation factor VIIa with human albumin for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-31T02:00:00Z","last_updated_date":"2011-05-31T02:00:00Z","reference_number":"EMA/COMP/158306/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311863-public-summary-opinion-orphan-designation-recombinant-fusion-protein-linking-human-coagulation-factor-viia-human-albumin-treatment-haemophilia-b_en.pdf"},
    {"id":"16451","name":"Letter on the working arrangement to exchange non-public information on medical products between the European Commission's Directorate General for Health and Food Safety (DG SANTE), European Medicines Agency and the Worl...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T12:00:00Z","last_updated_date":"2015-09-22T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-working-arrangement-exchange-non-public-information-medical-products-between-european-commissions-directorate-general-health-and-food-safety-dg-sante-european-medicines-agency-and-worl_en.pdf"},
    {"id":"16454","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Commiphora molmol Engler, gummi-resina","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T15:00:00Z","last_updated_date":"2011-12-22T15:00:00Z","reference_number":"EMA/HMPC/544935/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"16456","name":"Standard operating procedure for evaluation procedure for applications and requests for the establishment or review of Maximum Residue Limits (MRLs)","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2017-05-10T19:10:00Z","last_updated_date":"2017-05-10T19:10:00Z","reference_number":"SOP/V/4150","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-evaluation-procedure-applications-and-requests-establishment-or-review-maximum-residue-limits-mrls_en.pdf"},
    {"id":"16457","name":"Schering-Plough Europe withdraws its marketing authorisation application for Cylatron","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2009-03-16T01:00:00Z","reference_number":"EMEA/158824/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/schering-plough-europe-withdraws-its-marketing-authorisation-application-cylatron_en.pdf"},
    {"id":"16458","name":"Presentation - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations workplan 2012","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-workplan-2012_en.pdf"},
    {"id":"16460","name":"Presentation - On the utility of subgroup analyses in confirmatory clinical trials (Brian A. Millen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-utility-subgroup-analyses-confirmatory-clinical-trials-brian-millen_en.pdf"},
    {"id":"16462","name":"Tolfenamic acid: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-04-01T02:00:00Z","last_updated_date":"1997-04-01T02:00:00Z","reference_number":"EMEA/MRL/183/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tolfenamic-acid-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16463","name":"Draft list of references supporting the assessment of Tanacetum parthenium (L.) Schulz Bip.","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/HMPC/587580/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-tanacetum-parthenium-l-schulz-bip_en.pdf"},
    {"id":"16465","name":"CHMP post-authorisation summary of positive opinion for Revatio","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2011-03-18T01:00:00Z","reference_number":"EMA/CHMP/207927/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revatio_en.pdf"},
    {"id":"16468","name":"ICH: Q 4 B Annex 10: Polyacrylamide gel electrophoresis: Annex 10 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-06-01T02:00:00Z","last_updated_date":"2009-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/381133/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-10-polyacrylamide-gel-electrophoresis-annex-10-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-polyacrylamide-gel-electrophoresis-general-chapter-step-3_en.pdf"},
    {"id":"16470","name":"Presentation - Scientific advice: what to expect and how to prepare","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-31T19:00:00Z","last_updated_date":"2016-08-31T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advice-what-expect-and-how-prepare_en.pdf"},
    {"id":"16472","name":"Agenda - CAT agenda of the 19–20 June 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-06-24T18:00:00Z","last_updated_date":"2014-06-24T18:00:00Z","reference_number":"EMA/CAT/368856/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-19-20-june-2014-meeting_en.pdf"},
    {"id":"16473","name":"Chlorquinaldol (vaginal tablet) / promestriene: List of nationally authorised medicinal products - PSUSA/00009272/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-04T13:00:00Z","last_updated_date":"2017-07-04T16:12:22Z","reference_number":"EMA/405580/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorquinaldol-vaginal-tablet-promestriene-list-nationally-authorised-medicinal-products-psusa00009272201609_en.pdf"},
    {"id":"16479","name":"Etidronate: List of nationally authorised medicinal products - PSUSA/00001320/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T20:00:00Z","last_updated_date":"2018-05-23T20:22:17Z","reference_number":"EMA/325505/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/etidronate-list-nationally-authorised-medicinal-products-psusa00001320201709_en.pdf"},
    {"id":"16480","name":"Meeting of the EMEA working party on herbal medicinal products 28 - 29 October 1999","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-11-18T01:00:00Z","last_updated_date":"1999-11-18T01:00:00Z","reference_number":"EMEA/HMPWP/32/99","document_url":"https://www.ema.europa.eu/en/documents/public-statement/meeting-emea-working-party-herbal-medicinal-products-28-29-october-1999_en.pdf"},
    {"id":"16482","name":"Opinion following an Article 33 referral for Nisamox Lactating Cow and associated names: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-12-08T01:00:00Z","last_updated_date":"2011-12-08T01:00:00Z","reference_number":"EMEA/V/A/62","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-33-referral-nisamox-lactating-cow-and-associated-names-background-information_sv.pdf"}},
    {"id":"16484","name":"Final public statement on Angelica sinensis (Oliv.) Diels, radix - First version","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-11-25T01:00:00Z","last_updated_date":"2013-11-25T01:00:00Z","reference_number":"EMA/HMPC/681574/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
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    {"id":"16613","name":"Hydroxyethyl starch Article-107i procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-14T16:00:00Z","last_updated_date":"2013-11-14T16:00:00Z","reference_number":"EMA/667553/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-prac-assessment-report_en.pdf"},
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    {"id":"16618","name":"CHMP summary of positive opinion for Pravafenix","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/37551/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pravafenix_en.pdf"},
    {"id":"16619","name":"EU/3/14/1255: Public summary of opinion on orphan designation: Volasertib for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-06T02:00:00Z","last_updated_date":"2014-05-06T02:00:00Z","reference_number":"EMA/COMP/93562/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141255-public-summary-opinion-orphan-designation-volasertib-treatment-acute-myeloid-leukaemia_en.pdf"},
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    {"id":"16621","name":"Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T11:10:00Z","last_updated_date":"2018-01-18T11:10:00Z","reference_number":"EMA/34468/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/methoxyflurane-list-nationally-authorised-medicinal-products-psusa00010484201705_en.pdf"},
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    {"id":"16623","name":"Public statement on Sonata: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-10-21T02:00:00Z","last_updated_date":"2015-10-21T02:00:00Z","reference_number":"EMEA/H/C/000227","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-sonata-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"16627","name":"EU/3/18/2033: Public summary of opinion on orphan designation: Codon-optimised human ornithine transcarbamylase mRNA complexed with lipid-based nanoparticles for the treatment of ornithine transcarbamylase deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T18:32:00Z","last_updated_date":"2018-08-21T18:32:00Z","reference_number":"EMA/395377/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182033-public-summary-opinion-orphan-designation-codon-optimised-human-ornithine-transcarbamylase-mrna-complexed-lipid-based-nanoparticles-treatment-ornithine-transcarbamylase-deficiency_en.pdf"},
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    {"id":"16629","name":"Summary of the evaluation of the proposed paediatric investigation plan: Sotagliflozin for treatment of type 1 diabetes mellitus","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-19T02:00:00Z","last_updated_date":"2015-10-19T02:00:00Z","reference_number":"EMA/628992/2015","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-sotagliflozin-treatment-type-1-diabetes-mellitus_en.pdf"},
    {"id":"16630","name":"Visit of IberoAmerican regulatory authorities to the Spanish Ministry of Health and Consumer Affairs (Madrid) and to the EMEA (London) - 18-20 February 1997","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-02-20T01:00:00Z","last_updated_date":"1997-02-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/visit-iberoamerican-regulatory-authorities-spanish-ministry-health-and-consumer-affairs-madrid-and-emea-london-18-20-february-1997_en.pdf"},
    {"id":"16631","name":"Call for submission of scientific data relating to the assessment of Oleae folium Olea europaea L., folium","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2008-06-16T02:09:21Z","last_updated_date":"2008-06-16T02:09:21Z","reference_number":"EMEA/HMPC/245033/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-oleae-folium-olea-europaea-l-folium_en.pdf"},
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    {"id":"16633","name":"Public statement on Optaflu: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-06-27T02:00:00Z","last_updated_date":"2017-06-27T02:00:00Z","reference_number":"EMA/376617/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-optaflu-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"16635","name":"New medicine to protect honey bees against Varroa mites","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T16:29:00Z","last_updated_date":"2016-10-07T16:29:00Z","reference_number":"EMA/CVMP/655440/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-protect-honey-bees-against-varroa-mites_en.pdf"},
    {"id":"16639","name":"Presentation - EMA questions - Overview of expert responses","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-22T01:00:00Z","last_updated_date":"2011-03-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-questions-overview-expert-responses_en.pdf"},
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    {"id":"16643","name":"Outcome of Management Board written procedures during the period from 17 October 2010 to 24 November 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/MB/739297/2010","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-management-board-written-procedures-during-period-17-october-2010-24-november-2010_en.pdf"},
    {"id":"16645","name":"EU/3/18/1993: Public summary of opinion on orphan designation: Gemfibrozil for the treatment of neuronal ceroid lipofuscinosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-14T02:00:00Z","last_updated_date":"2018-05-14T02:00:00Z","reference_number":"EMA/120664/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181993-public-summary-opinion-orphan-designation-gemfibrozil-treatment-neuronal-ceroid-lipofuscinosis_en.pdf"},
    {"id":"16647","name":"Committee for medicinal products for veterinary use: Meeting of 9-11 December 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-12-12T00:09:21Z","last_updated_date":"2008-12-12T00:09:21Z","reference_number":"EMEA/CVMP/585012/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-9-11-december-2008_en.pdf"},
    {"id":"16648","name":"Request form for eligibility for double daily allowance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-05T14:30:00Z","last_updated_date":"2019-02-27T15:27:00Z","reference_number":"EMA/210753/2012","document_url":"https://www.ema.europa.eu/en/documents/other/request-form-eligibility-double-daily-allowance_en.docx"},
    {"id":"16651","name":"PDCO monthly report of opinions on paediatric investigation plans: 6-8 June 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-06-20T16:35:00Z","last_updated_date":"2012-06-20T16:35:00Z","reference_number":"EMA/PDCO/347974/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-6-8-june-2012_en.pdf"},
    {"id":"16652","name":"CHMP statistics: February 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T01:00:00Z","last_updated_date":"2017-02-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-february-2017_en.pdf"},
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    {"id":"16658","name":"Zinc salts: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-06-01T02:00:00Z","last_updated_date":"1996-06-01T02:00:00Z","reference_number":"EMEA/MRL/113/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/zinc-salts-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16660","name":"Presentation - Objectives of  session on communication and information on medicines (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-session-communication-and-information-medicines-isabelle-moulon_en.pdf"},
    {"id":"16661","name":"Presentation - European Union regulatory perspective on the potential use of biomarkers in Alzheimer's disease drug development (Valentina Mantua)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-union-regulatory-perspective-potential-use-biomarkers-alzheimers-disease-drug-development-valentina-mantua_en.pdf"},
    {"id":"16663","name":"Presentation - Summary of substance sessions at task force and built upon at the follow up identification of medicinal products (IDMP) workshop","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summary-substance-sessions-task-force-and-built-upon-follow-identification-medicinal-products-idmp-workshop_en.pdf"},
    {"id":"16664","name":"Meeting of the EMEA working party on herbal medicinal products 11 and 12 March 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-03-18T01:00:00Z","last_updated_date":"2002-03-18T01:00:00Z","reference_number":"EMEA/HMPWP/227/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-11-and-12-march-2002_en.pdf"},
    {"id":"16666","name":"EU/3/14/1238: Public summary of opinion on orphan designation: Eculizumab for the prevention of delayed graft function after solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-01T14:00:00Z","last_updated_date":"2017-05-17T14:00:00Z","reference_number":"EMA/COMP/36006/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141238-public-summary-opinion-orphan-designation-eculizumab-prevention-delayed-graft-function-after-solid-organ-transplantation_en.pdf"},
    {"id":"16668","name":"Overview of comments received on Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix - First version","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2012-08-24T17:00:00Z","last_updated_date":"2014-04-02T15:40:00Z","reference_number":"EMA/HMPC/48932/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-glycyrrhiza-glabra-l-andor-glycyrrhiza-inflata-bat-andor-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"16670","name":"EU/3/02/106: Public summary of positive opinion for orphan designation of antisense NF-kBp65 oligonucleotide for the treatment of active ulcerative colitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-23T00:00:00Z","last_updated_date":"2015-03-23T13:30:00Z","reference_number":"EMA/COMP/1500/2002 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302106-public-summary-positive-opinion-orphan-designation-antisense-nf-kbp65-oligonucleotide-treatment-active-ulcerative-colitis_en.pdf"},
    {"id":"16671","name":"CHMP post-authorisation summary of positive opinion for Ecalta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/430755/2014 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ecalta_en.pdf"},
    {"id":"16672","name":"Presentation - Perspectives for the future: Member States perspective (Sabine Straus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-29T18:30:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-perspectives-future-member-states-perspective-sabine-straus_en.pdf"},
    {"id":"16674","name":"Final assessment report on Levisticum officinale Koch, radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-02-22T16:00:00Z","last_updated_date":"2013-02-22T16:00:00Z","reference_number":"EMA/HMPC/524623/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-levisticum-officinale-koch-radix_en.pdf"},
    {"id":"16677","name":"Overview of comments received on 'Draft guideline on the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Revision 1'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2007-11-12T01:00:00Z","last_updated_date":"2007-11-12T01:00:00Z","reference_number":"EMEA/CVMP/EWP/203830/2007","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestations-dogs-and-cats-revision-1_en.pdf"},
    {"id":"16678","name":"CHMP summary of positive opinion for Terrosa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/714649/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-terrosa_en.pdf"},
    {"id":"16679","name":"Adaptive Pathways Workshop - Report on a meeting with stakeholders (8 December 2016)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-23T15:55:00Z","last_updated_date":"2017-02-23T15:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/adaptive-pathways-workshop-report-meeting-stakeholders-8-december-2016_en.pdf"},
    {"id":"16680","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 13 to note for evaluation and recommendation of pharmacopoeial texts for use...","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T12:00:00Z","reference_number":"EMA/CHMP/ICH/405290/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q4b-annex-13-note-evaluation-and-recommendation-pharmacopoeial-texts-use_en.pdf"},
    {"id":"16681","name":"COMP meeting report on the review of applications for orphan designation: January 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-01-16T16:50:00Z","last_updated_date":"2014-01-16T16:50:00Z","reference_number":"EMA/COMP/741655/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-january-2014_en.pdf"},
    {"id":"16684","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 22 – 25 June 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/CHMP/SAWP/428252/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-22-25-june-2015_en.pdf"},
    {"id":"16688","name":"Committee for proprietary medicinal products April 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-04-28T02:00:00Z","last_updated_date":"2002-04-28T02:00:00Z","reference_number":"EMEA/CPMP/8204/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-april-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"16690","name":"Furosemide / spironolactone: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001493/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-25T02:00:00Z","last_updated_date":"2016-10-18T13:42:38Z","reference_number":"EMA/729829/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/furosemide-spironolactone-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001493201512_en.pdf"},
    {"id":"16691","name":"Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:30:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"EMA/405642/2017","document_url":"https://www.ema.europa.eu/en/documents/other/report-focus-group-meeting-invited-stakeholders-field-efficacy-trials-context-eu-authorisation-veterinary-vaccines_en.pdf"},
    {"id":"16692","name":"CVMP summary of positive opinion for Kexxtone","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-11-09T16:30:00Z","last_updated_date":"2012-11-09T16:30:00Z","reference_number":"EMA/670976/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-kexxtone_en.pdf"},
    {"id":"16693","name":"IAAP statements at EMEA 'Homeopathic workshop'","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/iaap-statements-emea-homeopathic-workshop_en.pdf"},
    {"id":"16694","name":"Draft assessment report on Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-07-24T02:00:00Z","last_updated_date":"2014-07-24T02:00:00Z","reference_number":"EMA/HMPC/55837/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-matricaria-recutita-l-flos-and-matricaria-recutita-l-aetheroleum-first-version_en.pdf"},
    {"id":"16695","name":"CHMP summary of positive opinion for Ivabradine JensonR","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2018-12-20T02:00:00Z","reference_number":"EMA/CHMP/605096/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ivabradine-jensonr_en.pdf"},
    {"id":"16701","name":"Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2014)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/9496/2015","document_url":"https://www.ema.europa.eu/en/documents/report/annual-report-european-medicines-agencys-interaction-patients-consumers-healthcare-professionals-and-their-organisations-2014_en.pdf"},
    {"id":"16704","name":"Working party on Herbal Medicinal Products: Draft proposal for a core data for Passion flower","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2000-03-31T02:00:00Z","last_updated_date":"2000-03-31T02:00:00Z","reference_number":"EMEA/HMPWP/18/00","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-draft-proposal-core-data-passion-flower_en.pdf"},
    {"id":"16707","name":"Agenda - PRAC draft agenda of meeting 3-6 February 2014","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-02-05T17:30:00Z","last_updated_date":"2014-02-05T17:30:00Z","reference_number":"EMA/PRAC/66008/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-3-6-february-2014_en.pdf"},
    {"id":"16710","name":"Draft guideline on the clinical development of medicinal products for the treatment of cystic fibrosis - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/CHMP/EWP/9147/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-treatment-cystic-fibrosis-first-version_en.pdf"},
    {"id":"16711","name":"Draft assessment report on Zingiberis rhizoma","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-09-20T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"EMA/HMPC/577856/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-zingiberis-rhizoma_en.pdf"},
    {"id":"16712","name":"Draft assessment report on Fucus vesiculosus L., thallus","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-08-19T02:00:00Z","last_updated_date":"2013-08-19T02:00:00Z","reference_number":"EMA/HMPC/313675/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-fucus-vesiculosus-l-thallus_en.pdf"},
    {"id":"16713","name":"Trandolapril / verapamil: List of nationally authorised medicinal products - PSUSA/00003005/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T13:00:00Z","last_updated_date":"2016-10-17T20:16:41Z","reference_number":"EMA/13478/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/trandolapril-verapamil-list-nationally-authorised-medicinal-products-psusa00003005201503_en.pdf"},
    {"id":"16714","name":"Flupirtine Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMEA/H/A-31/1458","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-review-started_en.pdf"},
    {"id":"16716","name":"European Medicines Agency makes first recommendation for use of a medicine in children based on PIP data","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-25T02:09:21Z","last_updated_date":"2008-09-25T02:09:21Z","reference_number":"EMEA/502830/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-makes-first-recommendation-use-medicine-children-based-pip-data_en.pdf"},
    {"id":"16719","name":"Highlights from the eighth European Medicines Agency Industry Platform meeting on the operation of European Union pharmacovigilance legislation - 1 July 2016","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-08-16T11:10:00Z","last_updated_date":"2016-08-16T11:10:00Z","reference_number":"EMA/459864/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/highlights-eighth-european-medicines-agency-industry-platform-meeting-operation-european-union-pharmacovigilance-legislation-1-july-2016_en.pdf"},
    {"id":"16720","name":"Questions and answers on the withdrawal of the application to change the marketing authorisation application for Draxxin","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-02-20T01:00:00Z","last_updated_date":"2007-02-20T01:00:00Z","reference_number":"EMEA/CVMP/58270/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-application-draxxin_en.pdf"},
    {"id":"16721","name":"Agenda - PRAC draft agenda of meeting 11-14 June 2018","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-06-11T17:00:00Z","last_updated_date":"2018-06-11T17:00:00Z","reference_number":"EMA/PRAC/395628/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-11-14-june-2018_en.pdf"},
    {"id":"16723","name":"CHMP summary of positive opinion for Benlysta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/296249/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-benlysta_en.pdf"},
    {"id":"16728","name":"Oxolinic acid (Extension to all food producing species): Summary report (5) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-02-01T01:00:00Z","last_updated_date":"2005-02-01T01:00:00Z","reference_number":"EMEA/CVMP/41090/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxolinic-acid-extension-all-food-producing-species-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16729","name":"Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-25T01:00:00Z","last_updated_date":"2020-05-15T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/council-regulation-ec-no-29795-10-february-1995-fees-payable-european-agency-evaluation-medicinal-products_en.pdf"},
    {"id":"16730","name":"Thelin (sitaxentan) to be withdrawn due to cases of unpredictable serious liver injury","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2010-12-10T01:00:00Z","reference_number":"EMA/804365/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/thelin-sitaxentan-be-withdrawn-due-cases-unpredictable-serious-liver-injury_en.pdf"},
    {"id":"16731","name":"EU/3/13/1126: Public summary of opinion on orphan designation: Mexiletine hydrochloride for the treatment of non-dystrophic myotonia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-06-25T19:00:00Z","reference_number":"EMA/COMP/277084/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131126-public-summary-opinion-orphan-designation-mexiletine-hydrochloride-treatment-non-dystrophic-myotonia_en.pdf"},
    {"id":"16732","name":"EU/3/16/1621: Public summary of opinion on orphan designation: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant for the treatment glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/72100/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161621-public-summary-opinion-orphan-designation-delta-9-tetrahydrocannabinol-and-cannabidiol-extracts-cannabis-sativa-l-plant-treatment-glioma_en.pdf"},
    {"id":"16734","name":"Opinion following an Article 31 referral for Loratadine and pseudoephedrine International Non-Proprietary Name (INN): loratadine and pseudoephedrine: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-04-28T02:08:21Z","last_updated_date":"2003-04-28T02:08:21Z","reference_number":"CPMP/4060/03","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-31-referral-loratadine-and-pseudoephedrine-international-non-proprietary-name-inn-loratadine-and-pseudoephedrine-background-information_sv.pdf"}},
    {"id":"16735","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revolade (eltrombopag olamine) for the treatment of idiopathic thrombocytopenic purpura","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-04-11T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMA/COMP/378290/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-revolade-eltrombopag-olamine-treatment-idiopathic-thrombocytopenic-purpura_en.pdf"},
    {"id":"16738","name":"Public Statement on Levacetylmethadol (Orlaam) - Life threatening ventricular rhythm disorders","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-12-19T01:00:00Z","last_updated_date":"2000-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-levacetylmethadol-orlaam-life-threatening-ventricular-rhythm-disorders_en.pdf"},
    {"id":"16740","name":"Gonadotrophin releasing hormone (Gonadorelin): Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gonadotrophin-releasing-hormone-gonadorelin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16744","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T15:30:00Z","last_updated_date":"2016-04-19T15:30:00Z","reference_number":"EMA/240985/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-derived-mesenchymal-stem-cells_en.pdf-0"},
    {"id":"16745","name":"CHMP post-authorisation summary of positive opinion for Opdivo","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-06-28T02:00:00Z","last_updated_date":"2018-06-28T02:00:00Z","reference_number":"EMA/CHMP/442334/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo_en.pdf-1"},
    {"id":"16748","name":"ChemGenex Europe SAS withdraws its marketing authorisation application for Tekinex (omacetaxine mepesuccinate)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-01-12T01:00:00Z","last_updated_date":"2011-01-12T01:00:00Z","reference_number":"EMA/9192/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/chemgenex-europe-sas-withdraws-its-marketing-authorisation-application-tekinex-omacetaxine-mepesuccinate_en.pdf"},
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    {"id":"16804","name":"Withdrawal letter: Elmisol","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-elmisol_en.pdf"},
    {"id":"16806","name":"Guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"CPMP/EWP/553/95 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-medicinal-products-treatment-alzheimers-disease-and-other-dementias-revision-1_en.pdf"},
    {"id":"16807","name":"News bulletin for small and medium-sized enterprises - Issue 20","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2012-07-11T16:05:00Z","last_updated_date":"2012-07-11T16:05:00Z","reference_number":"Issue 20","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-20_en.pdf"},
    {"id":"16808","name":"Presentation - Feedback from 6th annual workshop of European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (Adamos Hadjipanayis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-6th-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema-adamos-hadjipanayis_en.pdf"},
    {"id":"16809","name":"Presentation - Manufacturing Change for a Biological Product (V. LeBras, Merck)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-manufacturing-change-biological-product-v-lebras-merck_en.pdf"},
    {"id":"16814","name":"Withdrawal letter: Protelos","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-protelos_en.pdf"},
    {"id":"16815","name":"Presentation - 6.1 Historical controls: think cluster not parallel (Stephen Senn, Olivier Collignon, Anna Schritz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-61-historical-controls-think-cluster-not-parallel-stephen-senn-olivier-collignon-anna-schritz_en.pdf"},
    {"id":"16818","name":"Conduct of Pharmacovigilance for centrally authorised products","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-04-15T02:00:00Z","last_updated_date":"1997-04-15T02:00:00Z","reference_number":"CPMP/183/97","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/conduct-pharmacovigilance-centrally-authorised-products_en.pdf"},
    {"id":"16821","name":"Qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-05-02T16:00:00Z","last_updated_date":"2018-05-02T16:00:00Z","reference_number":"EMA/CHMP/SAWP/264260/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-plasma-fibrinogen-prognostic-biomarker-drug-development-tool-all-cause-mortality-and-copd-exacerbations-copd-subjects_en.pdf"},
    {"id":"16822","name":"Human medicines highlights - November 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-12-10T15:40:00Z","last_updated_date":"2015-12-10T15:40:00Z","reference_number":"Issue 81","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-november-2015_en.pdf"},
    {"id":"16824","name":"Presentation - PIP session: PDCO evaluation of ophthalmology paediatric investigation plans","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pip-session-pdco-evaluation-ophthalmology-paediatric-investigation-plans_en.pdf"},
    {"id":"16825","name":"VICH GL10: Impurities in new veterinary drug substances - Revision at step 9 for consultation at step 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-06-15T02:00:00Z","last_updated_date":"2005-06-15T02:00:00Z","reference_number":"CVMP/VICH/837/99-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl10-impurities-new-veterinary-drug-substances-revision-step-9-consultation-step-4_en.pdf"},
    {"id":"16828","name":"Diacerein: List of nationally authorised medicinal products - PSUSA/00001026/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T19:30:00Z","last_updated_date":"2017-10-23T19:44:01Z","reference_number":"EMA/704704/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/diacerein-list-nationally-authorised-medicinal-products-psusa00001026201612_en.pdf"},
    {"id":"16829","name":"EMEA completes the review of recombinant factor VIII products and\n\ninhibitor development","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-07-31T02:09:21Z","last_updated_date":"2007-07-31T02:09:21Z","reference_number":"EMEA/310225/2007 Corr","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-completes-review-recombinant-factor-viii-products-and-inhibitor-development_en.pdf"},
    {"id":"16830","name":"Draft assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-08-21T02:00:00Z","last_updated_date":"2013-08-21T02:00:00Z","reference_number":"EMA/HMPC/320932/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-andor-other-species-melaleuca-aetheroleum-first-version_en.pdf"},
    {"id":"16831","name":"Reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference a...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-11-21T15:15:00Z","last_updated_date":"2012-11-21T15:15:00Z","reference_number":"EMA/651649/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-considerations-given-designation-single-stereo-isomeric-form-enantiomer-complex-derivative-or-different-salt-or-ester-new-active-substance-relation-relevant-reference_en.pdf"},
    {"id":"16833","name":"Agenda and registration form - EMA EudraVigilance and signal management information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-02-16T12:04:00Z","last_updated_date":"2018-02-16T12:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-ema-eudravigilance-and-signal-management-information-day_en.pdf"},
    {"id":"16835","name":"European Medicines Agency recommends Acomplia must not be used in patients on antidepressants or with major depression","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/329826/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-acomplia-must-not-be-used-patients-antidepressants-or-major-depression_en.pdf"},
    {"id":"16836","name":"Opinion following an article 20 referral for veterinary medicinal products containing benzathine benzylpenicillin intended for administration to food-producing species","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2016-07-26T14:00:00Z","reference_number":"EMA/308369/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-20-referral-veterinary-medicinal-products-containing-benzathine-benzylpenicillin-intended-administration-food-producing-species_en.pdf"},
    {"id":"16837","name":"EU/3/12/1040: Public summary of opinion on orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)ace...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-26T16:30:00Z","last_updated_date":"2012-09-26T16:30:00Z","reference_number":"EMA/COMP/526568/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121040-public-summary-opinion-orphan-designation-2s-2-2r-2-33-dibutyl-7-methylthio-11-dioxido-5-phenyl-2345-tetrahydro-125-benzothiadiazepin-8-yloxyacetylamino-2-4-hydroxyphenylace_en.pdf"},
    {"id":"16840","name":"Scientific recommendation on classification of advanced therapy medicinal products: mRNA sequence encoding the wild type human OX40L protein","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:45:00Z","last_updated_date":"2017-02-28T14:45:00Z","reference_number":"EMA/126719/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-mrna-sequence-encoding-wild-type-human-ox40l-protein_en.pdf"},
    {"id":"16841","name":"Day 150 or Day 195 joint assessment report - Quality template - Rev. 05. 21","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2006-09-01T02:09:00Z","last_updated_date":"2021-06-25T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-150-or-day-195-joint-assessment-report-quality-template-rev-05-21_en.docx"},
    {"id":"16842","name":"Withdrawal assessment report for Nenad","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-03-16T01:00:00Z","last_updated_date":"2010-03-16T01:00:00Z","reference_number":"EMA/816879/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-nenad_en.pdf"},
    {"id":"16843","name":"EU/3/12/1058: Public summary of opinion on orphan designation: IL-12-secreting dendritic cells, loaded with autologous tumour lysate for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2012-12-12T01:00:00Z","reference_number":"EMA/COMP/657711/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121058-public-summary-opinion-orphan-designation-il-12-secreting-dendritic-cells-loaded-autologous-tumour-lysate-treatment-glioma_en.pdf"},
    {"id":"16847","name":"Cypermethrin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/403/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cypermethrin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16858","name":"Opinion of the CVMP on the establishment of maximum residue limits: Altrenogest","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-03-22T01:00:00Z","last_updated_date":"2012-03-22T01:00:00Z","reference_number":"EMA/CVMP/687242/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-altrenogest_en.pdf"},
    {"id":"16859","name":"Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure - Revision 1 - Superseded","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-12-01T01:00:00Z","last_updated_date":"2010-12-01T01:00:00Z","reference_number":"EMA/CHMP/BWP/99698/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/procedural-advice-submission-variations-annual-update-human-influenza-inactivated-vaccines-applications-centralised-procedure-revision-1-superseded_en.pdf"},
    {"id":"16860","name":"Tylosin (extension to all food producing species): Summary Report (5) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T00:09:21Z","last_updated_date":"2002-01-01T00:09:21Z","reference_number":"EMEA/MRL/829/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tylosin-extension-all-food-producing-species-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16862","name":"Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-04T13:00:00Z","last_updated_date":"2016-10-17T16:31:00Z","reference_number":"EMA/1461/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-iv-formulation-list-nationally-authorised-medicinal-products-psusa00002311201505_en.pdf"},
    {"id":"16863","name":"Final assessment report on Fraxinus excelsior L. or Fraxinus angustifolia Vahl, folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:40:00Z","last_updated_date":"2012-06-18T16:40:00Z","reference_number":"EMA/HMPC/239269/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-fraxinus-excelsior-l-or-fraxinus-angustifolia-vahl-folium_en.pdf"},
    {"id":"16864","name":"Presentation - Topic 4 - Improving the handling of paediatric investigation plan (PIP) applications- Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-4-improving-handling-paediatric-investigation-plan-pip-applications-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation_en.pdf"},
    {"id":"16868","name":"Presentation - Clinical development and innovation in engineered T cell therapies (Bruce Levine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-development-and-innovation-engineered-t-cell-therapies-bruce-levine_en.pdf"},
    {"id":"16870","name":"EU/3/12/993: Public summary of opinion on orphan designation: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the treatment of neurofibromatosis type 2","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:55:00Z","last_updated_date":"2012-06-18T16:55:00Z","reference_number":"EMA/COMP/216967/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312993-public-summary-opinion-orphan-designation-n-hydroxy-4-3-methyl-2-s-phenyl-butyrylamino-benzamide-treatment-neurofibromatosis-type-2_en.pdf"},
    {"id":"16871","name":"ICH: Q 6 A: Test procedures and acceptance criteria for new drug substances and new drug products: Chemical substances - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-05-01T02:00:00Z","last_updated_date":"2000-05-01T02:00:00Z","reference_number":"CPMP/ICH/367/96","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-6-test-procedures-and-acceptance-criteria-new-drug-substances-and-new-drug-products-chemical-substances-step-5_en.pdf"},
    {"id":"16873","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting 22-25 April 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T17:40:00Z","last_updated_date":"2014-04-29T17:40:00Z","reference_number":"EMA/124014/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-22-25-april-2014_en.pdf"},
    {"id":"16876","name":"Pradaxa: Product information as approved by the CHMP on 24 May 2012, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-25T12:00:00Z","last_updated_date":"2012-05-25T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pradaxa-product-information-approved-chmp-24-may-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"16877","name":"Public statement: Baraclude (entecavir): Occurrence of a resistant HIV variant in a patient co-infected with HIV and HBV","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-03-05T00:09:21Z","last_updated_date":"2007-03-05T00:09:21Z","reference_number":"EMEA/79902/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/public-statement-baraclude-entecavir-occurrence-resistant-hiv-variant-patient-co-infected-hiv-and-hbv_en.pdf"},
    {"id":"16879","name":"EU/3/13/1143: Public summary of opinion on orphan designation: Immortalised human C3A hepatoblastoma cells for the treatment of acute liver failure","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T14:00:00Z","last_updated_date":"2013-07-11T14:00:00Z","reference_number":"EMA/COMP/304298/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131143-public-summary-opinion-orphan-designation-immortalised-human-c3a-hepatoblastoma-cells-treatment-acute-liver-failure_en.pdf"},
    {"id":"16880","name":"EU/3/15/1563: Public summary of opinion on orphan designation: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-18T11:00:00Z","last_updated_date":"2015-11-18T11:00:00Z","reference_number":"EMA/COMP/603715/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151563-public-summary-opinion-orphan-designation-recombinant-human-interleukin-3-truncated-diphtheria-toxin-fusion-protein-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"16881","name":"EU/3/12/1098: Public summary of opinion on orphan designation: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotrophic factor for the treatment of ret...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/808529/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121098-public-summary-opinion-orphan-designation-encapsulated-human-retinal-pigment-epithelial-cell-line-transfected-plasmid-vector-expressing-human-ciliary-neurotrophic-factor-treatment-ret_en.pdf"},
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    {"id":"16886","name":"Overview of comments received on ‘Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-06-05T11:15:00Z","last_updated_date":"2015-06-05T11:15:00Z","reference_number":"EMA/HMPC/130616/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-microbiological-aspects-herbal-medicinal-products-and-traditional-herbal-medicinal-products_en.pdf"},
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    {"id":"16894","name":"Agenda – Thalidomide - Follow-up meeting with patients’ and victims’ organisations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-09-02T17:56:56Z","last_updated_date":"2011-10-18T17:31:00Z","reference_number":"EMA/540386/2011 Corr.","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-thalidomide-follow-meeting-patients-and-victims-organisations_en.pdf"},
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    {"id":"16907","name":"EMA Management Board: highlights of December 2016 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-december-2016-meeting_en.pdf"},
    {"id":"16908","name":"Metamizole: List of nationally authorised medicinal products - PSUSA/00001997/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-10T01:00:00Z","last_updated_date":"2016-10-18T11:29:36Z","reference_number":"EMA/PRAC/798943/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-list-nationally-authorised-medicinal-products-psusa00001997201504_en.pdf"},
    {"id":"16909","name":"Call for submission of scientific data on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, flos (lime flower) - First version","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/HMPC/160868/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-flos-lime-flower-first-version_en.pdf"},
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    {"id":"16915","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 4-6 December 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T15:00:00Z","last_updated_date":"2014-01-08T13:45:00Z","reference_number":"EMA/PDCO/751770/2013 Corr1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-4-6-december-2013_en.pdf"},
    {"id":"16917","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - December 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-12-31T00:00:00Z","last_updated_date":"2008-12-31T00:00:00Z","reference_number":"EMEA/30275/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-december-2008_en.pdf"},
    {"id":"16921","name":"Solacyl - Article 33 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-05-24T01:59:00Z","last_updated_date":"2008-05-24T01:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/solacyl-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"16924","name":"Superseded final community herbal monograph on Echinacea purpurea (L.) Moench, herba recens","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2015-04-13T02:09:21Z","reference_number":"EMEA/HMPC/104945/2006 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"16925","name":"Porcine prolactin (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2018-08-01T14:20:00Z","last_updated_date":"2018-08-01T14:20:00Z","reference_number":"EMA/CVMP/405782/2018","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/porcine-prolactin-porcine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"16926","name":"Annual report of the European Medicines Agency 2013","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2014-04-30T16:00:00Z","last_updated_date":"2014-05-08T15:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2013_en.pdf"},
    {"id":"16928","name":"CVMP summary of positive opinion for BTVPUR AlSap 1","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-10-15T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"EMA/CVMP/343642/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-btvpur-alsap-1_en.pdf"},
    {"id":"16929","name":"The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future: Part II: The European Medicines Agency Road Map Implementation Plan - attachments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-03-07T01:00:00Z","last_updated_date":"2005-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-road-map-2010-preparing-ground-future-part-ii-european-medicines-agency-road-map-implementation-plan-attachments_en.pdf"},
    {"id":"16931","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 April 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-05-08T11:33:00Z","last_updated_date":"2018-05-08T11:33:00Z","reference_number":"EMA/PDCO/274173/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-24-27-april-2018_en.pdf"},
    {"id":"16932","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 10–12 September 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-09-19T16:20:00Z","last_updated_date":"2014-09-19T16:20:00Z","reference_number":"EMA/PDCO/551023/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-10-12-september-2014_en.pdf"},
    {"id":"16935","name":"CHMP post-authorisation summary of positive opinion for Exjade","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2012-11-16T01:00:00Z","reference_number":"EMA/CHMP/698691/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-exjade_en.pdf"},
    {"id":"16936","name":"Revised position paper on the definition of substances capable of pharmacological action in the context of council directive 2001/82/EC, as amended, with particular reference to excipients and manufacturing materials","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-07-01T02:00:00Z","last_updated_date":"2004-07-01T02:00:00Z","reference_number":"EMEA/CVMP/072/97/Rev1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-position-paper-definition-substances-capable-pharmacological-action-context-council-directive-200182ec-amended-particular-reference-excipients-and-manufacturing-materials_en.pdf"},
    {"id":"16938","name":"EU/3/13/1172: Public summary of opinion on orphan designation: Idelalisib for the treatment of nodal marginal-zone lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-12T02:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/COMP/434307/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131172-public-summary-opinion-orphan-designation-idelalisib-treatment-nodal-marginal-zone-lymphoma_en.pdf"},
    {"id":"16940","name":"Presentation - Risk assessment and mitigation strategies for immune Responses to therapeutic proteins: the FDA perspective (Amy Rosenberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-assessment-and-mitigation-strategies-immune-responses-therapeutic-proteins-fda-perspective-amy-rosenberg_en.pdf"},
    {"id":"16941","name":"Draft assessment report on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-08-30T02:00:00Z","last_updated_date":"2011-08-30T02:00:00Z","reference_number":"EMA/HMPC/239269/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-fraxinus-excelsior-l-and-fraxinus-angustifolia-vahl-folium_en.pdf"},
    {"id":"16942","name":"Magnesium and its compounds: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/039/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/magnesium-and-its-compounds-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16943","name":"Annex A2 - EMA technical comments on the technical requirements with respect to the candidate host member states' offers to relocate EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T20:15:00Z","last_updated_date":"2017-10-03T20:15:00Z","reference_number":"EMA/589388/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annex-a2-ema-technical-comments-technical-requirements-respect-candidate-host-member-states-offers-relocate-ema_en.pdf"},
    {"id":"16947","name":"Cisatracurium: List of nationally authorised medicinal products - PSUSA/00000777/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T14:00:00Z","last_updated_date":"2016-10-17T20:25:29Z","reference_number":"EMA/346187/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cisatracurium-list-nationally-authorised-medicinal-products-psusa00000777201507_en.pdf"},
    {"id":"16949","name":"Overview of comments received on ‘the guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)’ (EMA/CHMP/BPWP/94033/2007), Rev.3","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-07-20T16:45:00Z","last_updated_date":"2018-07-20T16:45:00Z","reference_number":"EMA/CHMP/BPWP/604687/2009","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-emachmpbpwp940332007-rev3_en.pdf"},
    {"id":"16952","name":"Presentation - Differences in a biomarker’s predictive ability across racial groups","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-differences-biomarkers-predictive-ability-across-racial-groups_en.pdf"},
    {"id":"16953","name":"Presentation - Application of pharmacogenomics in pharmacokinetics at the Food and Drug Administration: Experience and expectations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-application-pharmacogenomics-pharmacokinetics-food-and-drug-administration-experience-and-expectations_en.pdf"},
    {"id":"16954","name":"Presentation - Session 3: Extrapolation plan and PK/PD studies\n\nPanel Discussion (Martin Posch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-extrapolation-plan-and-pkpd-studies-panel-discussion-martin-posch_en.pdf"},
    {"id":"16955","name":"Presentation - Update on PRAC work plan and impact strategy (June M. Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-25T16:03:00Z","last_updated_date":"2017-07-25T16:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-prac-work-plan-and-impact-strategy-june-m-raine_en.pdf"},
    {"id":"16956","name":"PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl starch","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T14:00:00Z","last_updated_date":"2013-06-14T14:00:00Z","reference_number":"EMA/349341/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-suspending-marketing-authorisations-infusion-solutions-containing-hydroxyethyl-starch_en.pdf"},
    {"id":"16959","name":"Presentation - Going viral. The state of play and potential of social media in 2016 (Mun-Keat Looi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-going-viral-state-play-and-potential-social-media-2016-mun-keat-looi_en.pdf"},
    {"id":"16961","name":"Presentation - Implementation of Clinical Trial Regulation – Update on EU-CT portal and database - EMA's PCWP and HCPWP joint meeting (Laura Pioppo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-clinical-trial-regulation-update-eu-ct-portal-and-database-emas-pcwp-and-hcpwp-joint-meeting-laura-pioppo_en.pdf"},
    {"id":"16963","name":"Overview of comments received on 'Draft guideline on non-clinical local tolerance testing of medicinal products’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-11-27T15:15:00Z","last_updated_date":"2015-11-27T15:15:00Z","reference_number":"EMA/699381/2000","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-non-clinical-local-tolerance-testing-medicinal-products_en.pdf"},
    {"id":"16964","name":"Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on live attenuated influenza vaccines - Superseded","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"1999-07-29T02:00:00Z","last_updated_date":"1999-07-29T02:00:00Z","reference_number":"CPMP/BWP/1765/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-proprietary-medicinal-products-cpmp-points-consider-live-attenuated-influenza-vaccines-superseded_en.pdf"},
    {"id":"16965","name":"Overview of comments received on Community herbal monograph on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-10-13T11:40:00Z","last_updated_date":"2011-10-13T11:40:00Z","reference_number":"EMA/HMPC/564527/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-viola-tricolor-l-andor-subspecies-viola-arvensis-murray-gaud-and-viola-vulgaris-koch-oborny-herba-cum-flore_en.pdf"},
    {"id":"16967","name":"Alteplase: List of nationally authorised medicinal products - PSUSA/00000112/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T17:30:00Z","last_updated_date":"2018-03-07T17:36:32Z","reference_number":"EMA/145053/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/alteplase-list-nationally-authorised-medicinal-products-psusa00000112201705_en.pdf"},
    {"id":"16969","name":"Presentation - Regulatory experience in application of modelling in dose selection","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-experience-application-modelling-dose-selection_en.pdf"},
    {"id":"16970","name":"List of participants of the European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting:  wo...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"EMA/407046/2015","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-wo_en.pdf"},
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    {"id":"16978","name":"Timolol (eye preparations): List of nationally authorised medicinal products - PSUSA/00010439/201607","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2017-04-11T19:40:00Z","last_updated_date":"2017-04-11T19:40:00Z","reference_number":"EMA/208664/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/timolol-eye-preparations-list-nationally-authorised-medicinal-products-psusa00010439201607_en.pdf"},
    {"id":"16979","name":"Handling by the CPMP of safety concerns for pre- and post-authorisation applications submitted in accordance with the centralised procedure","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-04-05T02:00:00Z","last_updated_date":"2004-04-05T02:00:00Z","reference_number":"EMEA/CPMP/4285/04/Final","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/handling-cpmp-safety-concerns-pre-and-post-authorisation-applications-submitted-accordance-centralised-procedure_en.pdf"},
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    {"id":"16983","name":"Almotriptan: List of nationally authorised medicinal products - PSUSA/00000101/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T12:30:00Z","last_updated_date":"2018-03-09T12:52:34Z","reference_number":"EMA/154280/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/almotriptan-list-nationally-authorised-medicinal-products-psusa00000101201706_en.pdf"},
    {"id":"16984","name":"Notification of annual update to the parallel distribution of a centrally authorised medicinal product","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T12:00:00Z","last_updated_date":"2015-02-04T14:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/notification-annual-update-parallel-distribution-centrally-authorised-medicinal-product_en.pdf"},
    {"id":"16985","name":"European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-10-24T02:09:21Z","last_updated_date":"2006-10-24T02:09:21Z","reference_number":"EMEA/413136/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-review-concludes-positive-benefit-risk-balance-non-selective-nsaids_en.pdf"},
    {"id":"16987","name":"Final list of references supporting the assessment of Thymus vulgaris L. and Thymus zygis L., herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-06-02T02:00:00Z","last_updated_date":"2014-06-02T02:00:00Z","reference_number":"EMA/HMPC/342335/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-thymus-vulgaris-l-and-thymus-zygis-l-herba_en.pdf"},
    {"id":"16989","name":"Bismuth subcitrate potassium / metronidazole / tetracycline: List of nationally authorised medicinal products - PSUSA/00010199/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-06T15:55:00Z","last_updated_date":"2018-03-06T15:55:00Z","reference_number":"EMA/142409/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/bismuth-subcitrate-potassium-metronidazole-tetracycline-list-nationally-authorised-medicinal-products-psusa00010199201705_en.pdf"},
    {"id":"16990","name":"PDCO meeting report 13-15 July 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-07-25T02:00:00Z","last_updated_date":"2011-08-19T02:00:00Z","reference_number":"EMA/PDCO/513837/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-13-15-july-2011_en.pdf"},
    {"id":"16991","name":"Abamectin (Extension to sheep): Summary Report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-05-01T02:00:00Z","last_updated_date":"2002-05-01T02:00:00Z","reference_number":"EMEA/MRL/813/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/abamectin-extension-sheep-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"16992","name":"EU/3/16/1757: Public summary of positive opinion for orphan designation of n-[(2S)-5-{[(1R, 2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,2,3-triazol-1-yl)benzamide, bis-to...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/620940/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161757-public-summary-positive-opinion-orphan-designation-n-2s-5-1r-2s-2-4-fluorophenylcyclopropylamino-1-4-methylpiperazin-1-yl-1-oxopentan-2-yl-4-1h-123-triazol-1-ylbenzamide-bis_en.pdf"},
    {"id":"16993","name":"Action Plan for Herbal Medicines 2010-2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-11T02:00:00Z","last_updated_date":"2010-06-11T02:00:00Z","reference_number":"EMA/831327/2009","document_url":"https://www.ema.europa.eu/en/documents/other/action-plan-herbal-medicines-2010-2011_en.pdf"},
    {"id":"16994","name":"Questions and answers on refusal of a change to the marketing authorisation for Javlor (vinflunine)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-12-10T01:00:00Z","reference_number":"EMA/587197/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-javlor-vinflunine_sv.pdf"}},
    {"id":"16995","name":"Presentation - Pharmacovigilance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:53Z","last_updated_date":"2012-06-15T17:10:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance_en.pdf"},
    {"id":"16997","name":"EU/3/03/180: Public summary of positive opinion for orphan designation\n\nof 4,5-dihydro-2-(2,4-dihydroxyphenyl)-4-methylthiazole-4(S)-carboxylic acid\n\nfor the treatment of chronic iron overload requiring chelation therapy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/1593/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303180-public-summary-positive-opinion-orphan-designation-45-dihydro-2-24-dihydroxyphenyl-4-methylthiazole-4s-carboxylic-acid-treatment-chronic-iron-overload-requiring-chelation-therapy_en.pdf"},
    {"id":"16998","name":"Thiocolchicoside: CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002927/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-21T16:49:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/thiocolchicoside-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002927201507_en.pdf"},
    {"id":"16999","name":"EU/3/10/826: Public summary of opinion on orphan designation: Para-aminosalicylic acid for the treatment of tuberculosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2014-10-16T18:00:00Z","reference_number":"EMA/COMP/671320/2010 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310826-public-summary-opinion-orphan-designation-para-aminosalicylic-acid-treatment-tuberculosis_en.pdf"},
    {"id":"17002","name":"Presentation - What is a European safety referral","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-07T01:00:00Z","last_updated_date":"2017-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-european-safety-referral_en.pdf"},
    {"id":"17003","name":"Agenda - Evaluation of Drugs in rare diseases, Eudipharm & EMEA seminar","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-02-15T00:09:21Z","last_updated_date":"2006-02-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-evaluation-drugs-rare-diseases-eudipharm-emea-seminar_en.pdf"},
    {"id":"17004","name":"Symbioflor 2 Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2017-03-24T18:00:00Z","reference_number":"EMA/CHMP/233611/2016 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/referral/symbioflor-2-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"17007","name":"Industry Proposals for Implementation of Prudent Use Wording","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/industry-proposals-implementation-prudent-use-wording_en.pdf"},
    {"id":"17010","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant modified vaccinia virus ankara (MVA) containing genetic sequences coding for the human mucin 1 and the human interleukin 2","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-28T13:00:00Z","last_updated_date":"2016-11-28T13:00:00Z","reference_number":"EMA/761529/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-modified-vaccinia-virus-ankara-mva-containing-genetic-sequences-coding-human-mucin-1-and-human-interleukin-2_en.pdf"},
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    {"id":"17013","name":"Overview of comments received on Community herbal monograph on Cucurbita pepo L, semen","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/196724/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"17015","name":"Agenda - Twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T15:08:00Z","last_updated_date":"2018-01-04T15:08:00Z","reference_number":"EMA/666321/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-twelfth-industry-stakeholder-platform-operation-pharmacovigilance-european-union_en.pdf"},
    {"id":"17018","name":"EU/3/14/1257: Public summary of opinion on orphan designation: Autologous CD34+ cells transduced with a lentiviral vector containing the human RAG1 gene for the treatment of recombination-activating gene 1 deficient seve...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-07T02:00:00Z","last_updated_date":"2014-05-07T02:00:00Z","reference_number":"EMA/COMP/89818/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141257-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-rag1-gene-treatment-recombination-activating-gene-1-deficient-seve_en.pdf"},
    {"id":"17019","name":"List of participants - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations plenary meeting with all eligible organisations: 30 November 2012 meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"EMA/725895/2012","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-plenary-meeting-all-eligible-organisations-30-november-2012-meeting_en.pdf"},
    {"id":"17020","name":"EU/3/01/050: Public summary of positive opinion for orphan designation of zinc acetate dihydrate for the treatment of Wilson's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-03T01:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMA/COMP/1293/2003 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301050-public-summary-positive-opinion-orphan-designation-zinc-acetate-dihydrate-treatment-wilsons-disease_en.pdf"},
    {"id":"17022","name":"Presentation - Draft principles for assignment of technical units of measurement (Kari Grave, Marian Bos, Jordi Torren Edo, Arno Muller)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T13:00:00Z","last_updated_date":"2015-04-20T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-principles-assignment-technical-units-measurement-kari-grave-marian-bos-jordi-torren-edo-arno-muller_en.pdf"},
    {"id":"17023","name":"EU/3/10/810: Public summary of opinion on orphan designation N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for the treatment of...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2013-04-09T02:00:00Z","reference_number":"EMA/COMP/601661/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310810-public-summary-opinion-orphan-designation-n-tert-butyl-3-5-methyl-2-4-2-pyrrolidin-1-ylethoxyphenylaminopyrimidin-4-ylamino-benzenesulfonamide-dihydrochloride-monohydrate-treatment_en.pdf"},
    {"id":"17024","name":"Ambroxol and bromhexine Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-12-02T01:00:00Z","reference_number":"EMA/PRAC/133132/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"17025","name":"Guideline on clinical investigation of recombinant and human plasma-derived factor IX products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-08-01T02:00:00Z","last_updated_date":"2011-08-01T02:00:00Z","reference_number":"EMA/CHMP/BPWP/144552/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-ix-products_en.pdf"},
    {"id":"17027","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Zejula (niraparib) for the treatment of ovarian cancer","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-12-04T17:42:00Z","last_updated_date":"2017-12-04T17:42:00Z","reference_number":"EMA/712784/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-zejula-niraparib-treatment-ovarian-cancer_en.pdf"},
    {"id":"17029","name":"European Medicines Agency facilitates interaction between small and medium-sized enterprises (SMEs)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-20T02:00:00Z","last_updated_date":"2010-12-20T02:00:00Z","reference_number":"EMA/784834/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-facilitates-interaction-between-small-and-medium-sized-enterprises-smes_en.pdf"},
    {"id":"17031","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 22 to 24 July 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-07-25T02:09:21Z","last_updated_date":"2003-07-25T02:09:21Z","reference_number":"EMEA/CPMP/3971/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-22-24-july-2003_en.pdf"},
    {"id":"17032","name":"Femara - Article 30 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-06-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/femara-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/femara-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/femara-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/femara-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/femara-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/femara-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/femara-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/femara-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/femara-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/femara-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/femara-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/femara-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/femara-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/femara-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/femara-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/femara-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/femara-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/femara-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/femara-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/femara-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/femara-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/femara-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/femara-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/femara-article-30-referral-annex-iii_no.pdf"}},
    {"id":"17035","name":"CHMP summary of positive opinion for Deltyba","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T13:00:00Z","last_updated_date":"2013-11-22T13:00:00Z","reference_number":"EMA/CHMP/713909/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-deltyba_en.pdf"},
    {"id":"17037","name":"EU/3/05/328: Public summary of positive opinion for orphan designation\n\nof (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone for ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMEA/COMP/317921/2005 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305328-public-summary-positive-opinion-orphan-designation-e-1s4s10s21r-7-z-ethylidene-421-diisopropyl-2-oxa-1213-dithia-582023-tetraazabicyclo876tricos-16-ene-3691922-pentone_en.pdf"},
    {"id":"17038","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T17:55:00Z","last_updated_date":"2017-02-28T17:55:00Z","reference_number":"EMA/CAT/126788/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-february-2017_en.pdf"},
    {"id":"17041","name":"Kogenate Bayer Article-20 procedure - Product information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-09T12:00:00Z","last_updated_date":"2014-04-09T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kogenate-bayer-article-20-procedure-product-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kogenate-bayer-article-20-procedure-product-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kogenate-bayer-article-20-procedure-product-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kogenate-bayer-article-20-procedure-product-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kogenate-bayer-article-20-procedure-product-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kogenate-bayer-article-20-procedure-product-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kogenate-bayer-article-20-procedure-product-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kogenate-bayer-article-20-procedure-product-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kogenate-bayer-article-20-procedure-product-information_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/kogenate-bayer-article-20-procedure-product-information_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kogenate-bayer-article-20-procedure-product-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kogenate-bayer-article-20-procedure-product-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kogenate-bayer-article-20-procedure-product-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kogenate-bayer-article-20-procedure-product-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kogenate-bayer-article-20-procedure-product-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kogenate-bayer-article-20-procedure-product-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kogenate-bayer-article-20-procedure-product-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kogenate-bayer-article-20-procedure-product-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kogenate-bayer-article-20-procedure-product-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kogenate-bayer-article-20-procedure-product-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kogenate-bayer-article-20-procedure-product-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kogenate-bayer-article-20-procedure-product-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kogenate-bayer-article-20-procedure-product-information_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/kogenate-bayer-article-20-procedure-product-information_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/kogenate-bayer-article-20-procedure-product-information_no.pdf"}},
    {"id":"17044","name":"Draft assessment report on Ricinus communis L., oleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-07-22T02:00:00Z","last_updated_date":"2015-07-22T02:00:00Z","reference_number":"EMA/HMPC/572973/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-ricinus-communis-l-oleum_en.pdf"},
    {"id":"17046","name":"Draft guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"EMEA/CHMP/89249/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-pharmacokinetics-therapeutic-proteins_en.pdf"},
    {"id":"17050","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 April 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/CHMP/SAWP/210613/20155","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-20-23-april-2015_en.pdf"},
    {"id":"17052","name":"Use of antibiotics in animals - European Medicines Agency to give advice to European Commission on public and animal health impact","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-16T12:00:00Z","last_updated_date":"2013-04-16T12:00:00Z","reference_number":"EMA/225000/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/use-antibiotics-animals-european-medicines-agency-give-advice-european-commission-public-and-animal-health-impact_en.pdf"},
    {"id":"17053","name":"Implementation of the note for guidance on the risk analysis approach for residues of veterinary medicinal products in food of animal origin","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/CVMP/069/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/implementation-note-guidance-risk-analysis-approach-residues-veterinary-medicinal-products-food-animal-origin_en.pdf"},
    {"id":"17054","name":"EU/3/14/1243: Public summary of opinion on orphan designation: Recombinant human acid ceramidase for the treatment of Farber disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-02T17:00:00Z","last_updated_date":"2015-05-13T17:00:00Z","reference_number":"EMA/COMP/32699/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141243-public-summary-opinion-orphan-designation-recombinant-human-acid-ceramidase-treatment-farber-disease_en.pdf"},
    {"id":"17056","name":"Use of flow cytometry for investigating immunomodulatory effects of medicines: Richard Stebbings, NIBSC, England","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/use-flow-cytometry-investigating-immunomodulatory-effects-medicines-richard-stebbings-nibsc-england_en.pdf"},
    {"id":"17057","name":"Presentation - Global research in paediatrics (GRiP) – Tools for Interoperability(Allison Needham, Anne Junker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-global-research-paediatrics-grip-tools-interoperabilityallison-needham-anne-junker_en.pdf"},
    {"id":"17058","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 11-12 July 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/HMPC/555872/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-11-12-july-2011_en.pdf"},
    {"id":"17059","name":"Metoclopramide Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metoclopramide-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metoclopramide-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metoclopramide-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metoclopramide-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metoclopramide-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metoclopramide-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metoclopramide-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metoclopramide-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metoclopramide-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metoclopramide-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metoclopramide-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metoclopramide-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metoclopramide-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metoclopramide-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metoclopramide-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metoclopramide-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metoclopramide-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metoclopramide-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metoclopramide-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metoclopramide-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metoclopramide-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metoclopramide-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metoclopramide-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/metoclopramide-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/metoclopramide-article-31-referral-annex-i_no.pdf"}},
    {"id":"17063","name":"Focus Group Meeting on Fluoroquinolones - Liisa Kaartinen/Gerard Moulin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/focus-group-meeting-fluoroquinolones-liisa-kaartinengerard-moulin_en.pdf"},
    {"id":"17064","name":"Utilisation of EudraGMDP database in regulatory procedures in the context of the mutual recognition agreement between Japan and the European Union - impact on good-manufacturing-practice certificates","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T15:50:00Z","last_updated_date":"2013-10-07T15:50:00Z","reference_number":"EMA/568361/2013","document_url":"https://www.ema.europa.eu/en/documents/other/utilisation-eudragmdp-database-regulatory-procedures-context-mutual-recognition-agreement-between-japan-and-european-union-impact-good-manufacturing-practice-certificates_en.pdf"},
    {"id":"17066","name":"Frovatriptan: List of nationally authorised medicinal products - PSUSA/00001484/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T18:52:00Z","last_updated_date":"2017-10-26T18:55:45Z","reference_number":"EMA/716519/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/frovatriptan-list-nationally-authorised-medicinal-products-psusa00001484201703_en.pdf"},
    {"id":"17068","name":"Committee for medicinal products for human use,  summary of positive opinion  for Viread","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T01:00:00Z","last_updated_date":"2008-03-20T01:00:00Z","reference_number":"EMEA/CHMP/146782/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-viread_en.pdf"},
    {"id":"17070","name":"Draft Community herbal monograph on Rheum palmatum L. and Rheum officinale Baillon, radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2007-07-05T02:09:21Z","reference_number":"EMEA/HMPC/189624/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-rheum-palmatum-l-and-rheum-officinale-baillon-radix_en.pdf"},
    {"id":"17071","name":"Public bulletin: Veterinary pharmacovigilance 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T15:16:00Z","last_updated_date":"2012-03-05T15:16:00Z","reference_number":"EMA/CVMP/PhVWP/987984/2011","document_url":"https://www.ema.europa.eu/en/documents/other/public-bulletin-veterinary-pharmacovigilance-2011_en.pdf"},
    {"id":"17072","name":"Final assessment report on Hedera helix  L., folium  - Revision 2","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2018-08-13T13:47:00Z","last_updated_date":"2018-08-13T13:47:00Z","reference_number":"EMA/HMPC/325715/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-hedera-helix-l-folium-revision-2_en.pdf"},
    {"id":"17075","name":"Presentation - Workshop on patient-support programmes and market-research programmes: Spectrum of programmes falling under the terms of patient-support and market-research programmes and the type of safety data collected...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T02:00:00Z","last_updated_date":"2013-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patient-support-programmes-and-market-research-programmes-spectrum-programmes-falling-under-terms-patient-support-and-market-research-programmes-and-type-safety-data-collected_en.pdf"},
    {"id":"17076","name":"Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-10-18T02:00:00Z","last_updated_date":"2007-10-18T02:00:00Z","reference_number":"CHMP/EWP/2459/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-methodological-issues-confirmatory-clinical-trials-planned-adaptive-design_en.pdf"},
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    {"id":"17085","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Prague)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T12:57:00Z","last_updated_date":"2017-06-15T16:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-prague_en.pdf"},
    {"id":"17086","name":"Draft list of references for assessment of Hedera helix L., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2010-03-08T01:00:00Z","last_updated_date":"2015-02-12T01:00:00Z","reference_number":"EMA/HMPC/706540/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-hedera-helix-l-folium_en.pdf"},
    {"id":"17090","name":"Presentation - European Medicines Agency/PDCO summary report for PIP / waiver applications: revision of template and use in applications (Ralf Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T17:00:00Z","last_updated_date":"2016-05-27T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agencypdco-summary-report-pip-waiver-applications-revision-template-and-use-applications-ralf-herold_en.pdf"},
    {"id":"17091","name":"Module 11 - Presentation - EMA and international cooperation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/module-11-presentation-ema-and-international-cooperation_en.pdf"},
    {"id":"17092","name":"CHMP summary of positive opinion for Pantozol Control","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2009-02-18T01:00:00Z","reference_number":"EMEA/CHMP/23494/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pantozol-control_en.pdf"},
    {"id":"17093","name":"Periodic safety update report (PSUR) / Periodic safety update single assessment (PSUSA) submissions and expected PRAC outcome dates for bisphosphonates and denosumab","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-13T13:00:00Z","last_updated_date":"2015-03-13T13:00:00Z","reference_number":"EMA/171030/2015","document_url":"https://www.ema.europa.eu/en/documents/other/periodic-safety-update-report-psur-periodic-safety-update-single-assessment-psusa-submissions-and-expected-prac-outcome-dates-bisphosphonates-and-denosumab_en.pdf"},
    {"id":"17094","name":"Points to consider on the evaluation of medicinal products for the treatment of Irritable Bowel Syndrome","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-03-19T01:00:00Z","last_updated_date":"2003-03-19T01:00:00Z","reference_number":"CPMP/EWP/785/97","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-evaluation-medicinal-products-treatment-irritable-bowel-syndrome_en.pdf"},
    {"id":"17095","name":"Final Community herbal monograph on Levisticum officinale Koch, radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-02-22T16:00:00Z","last_updated_date":"2013-02-22T16:00:00Z","reference_number":"EMA/HMPC/524621/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-levisticum-officinale-koch-radix_en.pdf"},
    {"id":"17098","name":"CHMP positive summary of opinion for Ribavirin Three Rivers","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"EMA/CHMP/143985/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-ribavirin-three-rivers_en.pdf"},
    {"id":"17099","name":"CHMP summary of positive opinion for Dutrebis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2017-04-27T02:00:00Z","reference_number":"EMA/CHMP/38006/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dutrebis_en.pdf"},
    {"id":"17103","name":"EU/3/15/1585: Public summary of opinion on orphan designation: Sirolimus for the treatment of beta-thalassaemia intermedia and major","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/COMP/789714/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151585-public-summary-opinion-orphan-designation-sirolimus-treatment-beta-thalassaemia-intermedia-and-major_en.pdf"},
    {"id":"17105","name":"Tienam - Article 30 Referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-20T01:00:00Z","last_updated_date":"2012-02-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tienam-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tienam-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tienam-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tienam-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tienam-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tienam-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tienam-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tienam-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tienam-article-30-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tienam-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tienam-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tienam-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tienam-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tienam-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tienam-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tienam-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tienam-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tienam-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tienam-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tienam-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tienam-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tienam-article-30-referral-annex-i_sv.pdf"}},
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    {"id":"17111","name":"Moxifloxacin - Article 107 procedures - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-07-24T02:08:21Z","last_updated_date":"2007-07-24T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/moxifloxacin-article-107-procedures-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/moxifloxacin-article-107-procedures-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/moxifloxacin-article-107-procedures-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/moxifloxacin-article-107-procedures-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/moxifloxacin-article-107-procedures-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/moxifloxacin-article-107-procedures-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/moxifloxacin-article-107-procedures-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/moxifloxacin-article-107-procedures-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/moxifloxacin-article-107-procedures-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/moxifloxacin-article-107-procedures-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/moxifloxacin-article-107-procedures-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/moxifloxacin-article-107-procedures-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/moxifloxacin-article-107-procedures-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/moxifloxacin-article-107-procedures-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/moxifloxacin-article-107-procedures-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/moxifloxacin-article-107-procedures-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/moxifloxacin-article-107-procedures-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/moxifloxacin-article-107-procedures-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/moxifloxacin-article-107-procedures-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/moxifloxacin-article-107-procedures-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/moxifloxacin-article-107-procedures-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/moxifloxacin-article-107-procedures-annex-ii_sv.pdf"}},
    {"id":"17112","name":"PRAC recommends restricting the use of codeine when used for pain relief in children","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"EMA/350259/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-restricting-use-codeine-when-used-pain-relief-children_en.pdf"},
    {"id":"17116","name":"Agenda - Workshop on endpoints for cystic fibrosis","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-07-02T14:00:00Z","last_updated_date":"2012-12-11T17:05:00Z","reference_number":"EMA/895687/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-endpoints-cystic-fibrosis_en.pdf"},
    {"id":"17117","name":"EU/3/07/493: Public summary of  positive opinion for orphan designation of isofagomine tartrate for the treatment of Gaucher disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-08-12T02:00:00Z","last_updated_date":"2010-03-15T01:00:00Z","reference_number":"EMEA/COMP/488315/2007 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307493-public-summary-positive-opinion-orphan-designation-isofagomine-tartrate-treatment-gaucher-disease_en.pdf"},
    {"id":"17123","name":"Agenda and registration form - EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area (Vienna, Austria)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-29T13:30:00Z","reference_number":"Course #15519","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-european-economic-area-vienna-austria_en.pdf"},
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    {"id":"17254","name":"EMEA public statement on Valdecoxib and parecoxib sodium _cardiovascular risks in coronary artery bypass graft surgery and serious adverse skin reactions","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-12-15T01:00:00Z","last_updated_date":"2004-12-15T01:00:00Z","reference_number":"EMEA/204802/2004","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-valdecoxib-and-parecoxib-sodium-_cardiovascular-risks-coronary-artery-bypass-graft-surgery-and-serious-adverse-skin-reactions_en.pdf"},
    {"id":"17255","name":"EU/3/18/2028: Public summary of opinion on orphan designation: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochlo...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T12:33:00Z","last_updated_date":"2021-06-01T13:56:00Z","reference_number":"EMA/381666/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182028-public-summary-opinion-orphan-designation-r-1-3-aminomethyl-phenyl-n-5-3-cyanophenylcyclopropylmethylaminomethyl-2-fluorophenyl-3-trifluoromethyl-1h-pyrazole-5-carboxamide-dihydrochlo_en.pdf"},
    {"id":"17257","name":"Presentation - Chronic Intractable Diarrhoea of infancy (Nick Croft)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chronic-intractable-diarrhoea-infancy-nick-croft_en.pdf"},
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    {"id":"17323","name":"Methylprednisolone (bovine milk after provisional MRLs): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T15:00:00Z","last_updated_date":"2012-02-20T15:00:00Z","reference_number":"EMA/CVMP/664126/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/methylprednisolone-bovine-milk-after-provisional-mrls-european-public-mrl-assessment-report-epmar-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"17324","name":"Didanosine Article-29 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-12-10T01:00:00Z","last_updated_date":"2013-12-10T01:00:00Z","reference_number":"EMA/686289/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/didanosine-article-29-referral-assessment-report_en.pdf"},
    {"id":"17325","name":"Presentation - 2.4 Combining evidence : purpose is everything (Stephen Senn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-24-combining-evidence-purpose-everything-stephen-senn_en.pdf"},
    {"id":"17326","name":"Important new pharmacokinetic data demonstrating that REYATAZ (atazanavir\n\nsulfate) combined with NORVIR (ritonavir) and omeprazole should not be co-administered","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-12-22T00:31:00Z","last_updated_date":"2004-12-22T00:31:00Z","reference_number":"EMEA/202649/2004","document_url":"https://www.ema.europa.eu/en/documents/public-statement/important-new-pharmacokinetic-data-demonstrating-reyataz-atazanavir-sulfate-combined-norvir-ritonavir-and-omeprazole-should-not-be-co-administered_en.pdf"},
    {"id":"17327","name":"CHMP summary of positive opinion for Pregabalin Mylan Pharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2022-04-26T14:00:00Z","reference_number":"EMA/CHMP/236014/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pregabalin-mylan-pharma_en.pdf"},
    {"id":"17328","name":"Netobimin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/556/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/netobimin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17330","name":"Presentation - Cognition and fatigue as major determinants of disability (Bernd C. Kieseier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cognition-and-fatigue-major-determinants-disability-bernd-c-kieseier_en.pdf"},
    {"id":"17331","name":"Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally authorised products (CAPs)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-06-04T14:00:01Z","last_updated_date":"2018-06-04T14:00:01Z","reference_number":"EMA/CVMP/PhVWP/171122/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-recommendation-basic-surveillance-eudravigilance-veterinary-evvet-data-centrally-authorised-products-caps_en.pdf"},
    {"id":"17332","name":"Presentation - EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema_en.pdf"},
    {"id":"17333","name":"CHMP post-authorisation summary of positive opinion for Aptivus on 23 April 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:09:21Z","last_updated_date":"2009-04-23T02:09:21Z","reference_number":"EMEA/CHMP/232607/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-aptivus-23-april-2009_en.pdf"},
    {"id":"17334","name":"Human medicines highlights - May 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-06-05T17:00:00Z","last_updated_date":"2015-06-05T17:00:00Z","reference_number":"Issue 75","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-may-2015_en.pdf"},
    {"id":"17335","name":"EU/3/09/670: Public summary of positive opinion for orphan designation of pasireotide for the treatment of acromegaly","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/COMP/454500/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309670-public-summary-positive-opinion-orphan-designation-pasireotide-treatment-acromegaly_en.pdf"},
    {"id":"17337","name":"Presentation - Digital Media and Health Topic Group- EMA's PCWP and HCPWP joint meeting (Caroline Morton-Gallagher)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-digital-media-and-health-topic-group-emas-pcwp-and-hcpwp-joint-meeting-caroline-morton-gallagher_en.pdf"},
    {"id":"17340","name":"EU/3/10/769: Public summary of opinion on orphan designation: 11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene for the treat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMA/COMP/360348/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310769-public-summary-opinion-orphan-designation-11-2-pyrrolidin-1-yl-ethoxy-1419-dioxa-5726-triaza-tetracyclo19311261812-heptacosa-125226358101227162123-decaene-treat_en.pdf"},
    {"id":"17341","name":"EU/3/05/332: Public summary of positive opinion for orphan designation\n\nof 1,2-bis(methylsulphonyl)-1-(2-chloroethyl)-2-[(methylamino)carbonyl]hydrazine for the treatment acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-02-09T01:00:00Z","last_updated_date":"2006-02-09T01:00:00Z","reference_number":"EMEA/COMP/355971/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305332-public-summary-positive-opinion-orphan-designation-12-bismethylsulphonyl-1-2-chloroethyl-2-methylaminocarbonylhydrazine-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"17344","name":"EU/3/16/1774: Public summary of positive opinion for orphan designation of allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2 and dexamethasone for treatment in haematop...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2022-08-10T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161774-public-summary-positive-opinion-orphan-designation-allogeneic-peripheral-blood-mononuclear-cells-incubated-ex-vivo-16-16-dimethyl-prostaglandin-e2-and-dexamethasone-treatment-haematop_en.pdf"},
    {"id":"17345","name":"Trichlormethiazide (extension to dairy cows): Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-07-01T02:00:00Z","last_updated_date":"2002-07-01T02:00:00Z","reference_number":"EMEA/MRL/844/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/trichlormethiazide-extension-dairy-cows-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17346","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/CHMP/476111/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"17348","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Suspension of oncolytic adenovirus","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-06-05T10:48:00Z","last_updated_date":"2012-06-05T10:48:00Z","reference_number":"EMA/348841/2012","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-suspension-oncolytic-adenovirus_en.pdf"},
    {"id":"17349","name":"CHMP summary of positive opinion for Riximyo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/CHMP/76823/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-riximyo_en.pdf"},
    {"id":"17352","name":"CHMP draft Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products; Bioindustry Perspective - Christiane Abouzeid","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/chmp-draft-guideline-requirements-first-man-clinical-trials-potential-high-risk-medicinal-products-bioindustry-perspective-christiane-abouzeid_en.pdf"},
    {"id":"17355","name":"Withdrawal letter : Keytruda","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-keytruda_en.pdf"},
    {"id":"17357","name":"Guideline on requirements for First-in-man clinical trials For potential high-risk Medicinal products - JW van der Laan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/guideline-requirements-first-man-clinical-trials-potential-high-risk-medicinal-products-jw-van-der-laan_en.pdf"},
    {"id":"17359","name":"Fibrinogen Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T18:00:00Z","last_updated_date":"2013-04-02T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fibrinogen-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fibrinogen-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fibrinogen-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fibrinogen-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fibrinogen-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fibrinogen-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fibrinogen-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fibrinogen-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fibrinogen-article-31-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fibrinogen-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fibrinogen-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fibrinogen-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fibrinogen-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fibrinogen-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fibrinogen-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fibrinogen-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fibrinogen-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fibrinogen-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fibrinogen-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fibrinogen-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fibrinogen-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fibrinogen-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"17360","name":"CVMP monthly report of application procedures, guidelines and related documents: October 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-11-28T11:27:00Z","last_updated_date":"2013-11-28T11:27:00Z","reference_number":"EMA/673417/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-october-2013_en.pdf"},
    {"id":"17362","name":"EU/3/16/1713 : Public summary of opinion on orphan designation: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide for the treatment of scedosporiosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161713-public-summary-opinion-orphan-designation-2-15-dimethyl-3-phenyl-1h-pyrrol-2-yl-n-4-4-5-fluoro-pyrimidin-2-ylpiperazin-1-yl-phenyl-2-oxo-acetamide-treatment-scedosporiosis_en.pdf"},
    {"id":"17363","name":"Pharmacovigilance – Priya Bahri","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-08T02:00:00Z","last_updated_date":"2003-05-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/pharmacovigilance-priya-bahri_en.pdf"},
    {"id":"17365","name":"Agenda - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCP WG) joint meeting: September 2012","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-09-24T02:00:00Z","last_updated_date":"2012-11-26T17:00:00Z","reference_number":"EMA/43750/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-group-hcp-wg-joint-meeting-september-2012_en.pdf"},
    {"id":"17366","name":"EU/3/14/1408: Public summary of opinion on orphan designation: 5,5’-(4-(trifluromethyl)benzylazanediyl)bis(methylene)diquinolin-8-ol for the\n\ntreatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/COMP/722699/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141408-public-summary-opinion-orphan-designation-55-4-trifluromethylbenzylazanediylbismethylenediquinolin-8-ol-treatment-glioma_en.pdf"},
    {"id":"17367","name":"Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-11T11:28:00Z","last_updated_date":"2018-09-11T11:32:57Z","reference_number":"EMA/609153/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/felodipine-list-nationally-authorised-medicinal-products-psusa00001356201712_en.pdf"},
    {"id":"17370","name":"Presentation - Implementation of the EudraVigilance Access Policy for Centrally Authorised Products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T01:00:00Z","last_updated_date":"2011-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-eudravigilance-access-policy-centrally-authorised-products_en.pdf"},
    {"id":"17371","name":"Lasalocid sodium: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-10-01T02:00:00Z","last_updated_date":"2004-10-01T02:00:00Z","reference_number":"EMEA/MRL/912/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lasalocid-sodium-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17373","name":"Fludeoxyglucose (18f): List of nationally authorised medicinal products - PSUSA/00001437/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T12:50:00Z","last_updated_date":"2018-07-19T12:50:00Z","reference_number":"EMA/496103/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fludeoxyglucose-18f-list-nationally-authorised-medicinal-products-psusa00001437201711_en.pdf"},
    {"id":"17374","name":"EU/3/15/1576: Public summary of opinion on orphan designation: (5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide for the treatment ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/COMP/699954/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151576-public-summary-opinion-orphan-designation-5s8s10ar-n-benzhydryl-5-s-2-methylaminopropanamido-3-3-methylbutanoyl-6-oxodecahydropyrrolo12-a15diazocine-8-carboxamide-treatment_en.pdf"},
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    {"id":"17378","name":"Presentation - Workshop on patient’s voice in the evaluation of medicines - Benefit/Risk survey (M Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T01:00:00Z","last_updated_date":"2013-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patients-voice-evaluation-medicines-benefitrisk-survey-m-mavris_en.pdf"},
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    {"id":"17385","name":"EU/3/17/1873: Public summary of opinion on orphan designation: Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.al...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-29T02:00:00Z","last_updated_date":"2017-06-29T02:00:00Z","reference_number":"EMA/272964/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171873-public-summary-opinion-orphan-designation-polyoxy-12-ethanediylalpha-hydro-omega-hydroxy-1515-diester-n-acetyl-l-isoleucyl-l-cysteinyl-l-valyl-1-methyl-l-tryptophyl-l-glutaminyl-l-al_en.pdf"},
    {"id":"17387","name":"Ceftiofur (Modification of MRLs for bovine species): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-04-01T02:00:00Z","last_updated_date":"2002-04-01T02:00:00Z","reference_number":"EMEA/MRL/835/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ceftiofur-modification-mrls-bovine-species-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"17392","name":"Presentation - Novel biomarkers: pitfalls, limitations, emerging options (Bernard Fox) - S3.3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-novel-biomarkers-pitfalls-limitations-emerging-options-bernard-fox-s33_en.pdf"},
    {"id":"17394","name":"Oxfendazole, fenbendazole, febantel: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-28T01:00:00Z","last_updated_date":"1997-11-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxfendazole-fenbendazole-febantel-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17399","name":"European Medicines Agency/European Federation of Pharmaceutical Industries and Associations second workshop on adaptive design in confirmatory trials - Registration form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-04-02T02:09:21Z","last_updated_date":"2009-04-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/european-medicines-agencyeuropean-federation-pharmaceutical-industries-and-associations-second-workshop-adaptive-design-confirmatory-trials-registration-form_en.pdf"},
    {"id":"17400","name":"Presentation - What is a package leaflet – How to review it? (Claire Espinasse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-21T01:00:00Z","last_updated_date":"2015-01-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-package-leaflet-how-review-it-claire-espinasse_en.pdf-0"},
    {"id":"17401","name":"Points to be considered by applicants to the Horizon 2020 topic: New therapies for rare diseases","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-04-04T17:50:00Z","last_updated_date":"2016-04-04T17:50:00Z","reference_number":"EMA/819701/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/points-be-considered-applicants-horizon-2020-topic-new-therapies-rare-diseases_en.pdf"},
    {"id":"17402","name":"European Directorate for the Quality of Medicines and Healthcare (EDQM) participation at the CAT","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-12-20T01:00:00Z","last_updated_date":"2012-12-20T01:00:00Z","reference_number":"EMA/MB/740454/2012","document_url":"https://www.ema.europa.eu/en/documents/other/european-directorate-quality-medicines-and-healthcare-edqm-participation-cat_en.pdf"},
    {"id":"17403","name":"CHMP summary of positive opinion for Anagrelide Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/818102/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-anagrelide-mylan_en.pdf"},
    {"id":"17409","name":"Tixocortol, chlorhexidine gluconate / tixocortol pivalate : List of nationally authorised medicinal products - PSUSA/00010333/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-08-29T12:03:00Z","last_updated_date":"2017-08-29T12:11:10Z","reference_number":"EMA/431386/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tixocortol-chlorhexidine-gluconate-tixocortol-pivalate-list-nationally-authorised-medicinal-products-psusa00010333201611_en.pdf"},
    {"id":"17411","name":"Draft community herbal monograph on Calendula officinalis L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2007-07-05T02:09:21Z","reference_number":"EMEA/HMPC/179281/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-calendula-officinalis-l-flos_en.pdf"},
    {"id":"17412","name":"Agenda: International Neonatal Consortiu: Programme and agenda","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-international-neonatal-consortiu-programme-and-agenda_en.pdf"},
    {"id":"17414","name":"CHMP summary of positive opinion for Rasilamlo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-02-17T12:10:00Z","last_updated_date":"2017-03-28T13:10:00Z","reference_number":"EMA/CHMP/124404/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rasilamlo_en.pdf"},
    {"id":"17417","name":"WHO declares influenza pandemic – European Medicines Agency initiates crisis -management plan","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-12T02:00:00Z","last_updated_date":"2009-06-12T02:00:00Z","reference_number":"EMEA/367042/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/who-declares-influenza-pandemic-european-medicines-agency-initiates-crisis-management-plan_en.pdf"},
    {"id":"17418","name":"CHMP post-authorisation summary of positive opinion for Perjeta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/CHMP/334570/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-perjeta_en.pdf"},
    {"id":"17423","name":"Report on ESVAC trial for collecting data on consumption of antimicrobial agents in pigs","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-25T12:25:00Z","last_updated_date":"2016-05-25T12:25:00Z","reference_number":"EMA/836856/2015","document_url":"https://www.ema.europa.eu/en/documents/report/report-esvac-trial-collecting-data-consumption-antimicrobial-agents-pigs_en.pdf"},
    {"id":"17425","name":"Antimicrobial resistance - European Medicines Agency provides advice on use of colistin and tigecycline in animals","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-07-30T14:00:00Z","last_updated_date":"2013-07-30T14:00:00Z","reference_number":"EMA/443757/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/antimicrobial-resistance-european-medicines-agency-provides-advice-use-colistin-and-tigecycline-animals_en.pdf"},
    {"id":"17426","name":"Opinion of the HMPC on a Community herbal monograph on Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et Arn., Grindelia camporum Greene, herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-14T14:30:00Z","last_updated_date":"2013-03-14T14:30:00Z","reference_number":"EMA/HMPC/M/H/0124","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-grindelia-robusta-nutt-grindelia-squarrosa-pursh-dunal-grindelia-humilis-hook-et-arn-grindelia-camporum-greene-herba_en.pdf"},
    {"id":"17427","name":"Sulprostone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - 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    {"id":"17430","name":"Oxytocin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-18T01:00:00Z","last_updated_date":"1997-02-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxytocin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17431","name":"Antifibrinolytic medicines - Article-31 referral - Annex IV (aprotinin)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-06T01:00:00Z","last_updated_date":"2013-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-iv-aprotinin_sv.pdf"}},
    {"id":"17433","name":"Final list of references supporting the assessment of Levisticum officinale Koch, radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-02-22T16:00:00Z","last_updated_date":"2013-02-22T16:00:00Z","reference_number":"EMA/HMPC/524626/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-levisticum-officinale-koch-radix_en.pdf"},
    {"id":"17435","name":"CHMP summary of positive opinion for Xiapex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2020-03-02T01:00:00Z","reference_number":"EMA/CHMP/773322/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xiapex_en.pdf"},
    {"id":"17436","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 23-26 February 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-03-09T18:00:00Z","last_updated_date":"2015-03-09T18:00:00Z","reference_number":"EMA/27945/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-23-26-february-2015_en.pdf"},
    {"id":"17438","name":"Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-04-14T02:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/293780/2011 rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-recommendation-lift-suspension-octagam-human-normal-immunoglobulin-5-and-10_sv.pdf"}},
    {"id":"17439","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 20 – 23 February 2017","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2017-02-24T13:00:00Z","last_updated_date":"2017-02-24T13:00:00Z","reference_number":"EMA/121408/2017","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-20-23-february-2017_en.pdf"},
    {"id":"17443","name":"Committee for medicinal products for veterinary use: Meeting of 11-13 September 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-09-17T14:49:21Z","last_updated_date":"2007-09-17T14:49:21Z","reference_number":"EMEA/CVMP/381994/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-11-13-september-2007_en.pdf"},
    {"id":"17445","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: May 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T17:25:00Z","last_updated_date":"2018-06-19T17:25:00Z","reference_number":"EMA/CAT/372833/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-may-2018_en.pdf"},
    {"id":"17447","name":"Agenda – Ninth stakeholder forum on the Pharmacovigilance legislation:\n\nObservations on 3-years of operation and opportunities for the future","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-09-15T02:00:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"EMA/499552/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ninth-stakeholder-forum-pharmacovigilance-legislation-observations-3-years-operation-and-opportunities-future_en.pdf"},
    {"id":"17448","name":"PRAC recommends strengthening the restrictions on the use of valproate in women and girls","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2014-10-10T02:00:00Z","reference_number":"EMA/612389/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-strengthening-restrictions-use-valproate-women-and-girls_en.pdf"},
    {"id":"17450","name":"Final list of references supporting the assessment of Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/897341/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-paullinia-cupana-kunth-ex-hbk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
    {"id":"17455","name":"INFAI withdraws its marketing authorisation application for Gastromotal","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-16T00:09:21Z","last_updated_date":"2007-11-16T00:09:21Z","reference_number":"EMEA/521472/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/infai-withdraws-its-marketing-authorisation-application-gastromotal_en.pdf"},
    {"id":"17459","name":"Questions and Answers relating to EMEA ITT – EMEA-2004-27-PM-IT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-10-29T02:09:21Z","last_updated_date":"2004-10-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-emea-itt-emea-2004-27-pm-it_en.pdf"},
    {"id":"17460","name":"Draft list of references supporting the assessment of Carum carvi L., fructus and Carum carvi L. aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-12-22T17:15:00Z","last_updated_date":"2014-12-22T17:15:00Z","reference_number":"EMA/HMPC/242200/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-carum-carvi-l-fructus-and-carum-carvi-l-aetheroleum_en.pdf-0"},
    {"id":"17461","name":"EU/3/04/214: Public summary of positive opinion for orphan designation of midostaurin for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-11T02:00:00Z","last_updated_date":"2015-02-10T01:00:00Z","reference_number":"EMEA/COMP/374/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304214-public-summary-positive-opinion-orphan-designation-midostaurin-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"17462","name":"Hydroxyethyl starch Article-107i referral - Stakeholder's submission form","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMEA/H/A-107i/1457","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-stakeholders-submission-form_en.pdf"},
    {"id":"17464","name":"International Coalition of Medicines Regulatory Authorities (ICMRA) Zika virus disease press release: global medicines regulators pledge support to tackle Zika virus disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-11T12:00:00Z","last_updated_date":"2016-02-11T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/international-coalition-medicines-regulatory-authorities-icmra-zika-virus-disease-press-release-global-medicines-regulators-pledge-support-tackle-zika-virus-disease_en.pdf"},
    {"id":"17466","name":"Final Community herbal monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T13:00:00Z","last_updated_date":"2014-05-12T13:00:00Z","reference_number":"EMA/HMPC/604600/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-curcuma-xanthorrhiza-roxb-c-xanthorrhiza-d-dietrich-rhizoma_en.pdf"},
    {"id":"17467","name":"Superseded assessment report on Echinacea purpurea (L.) Moench., herba recens","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-03-06T00:09:21Z","last_updated_date":"2015-04-14T01:09:21Z","reference_number":"EMEA/HMPC/104918/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"17469","name":"CHMP post authorisation summary of positive opinion for Pegintron","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2021-06-03T01:00:00Z","reference_number":"EMA/CHMP/114051/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pegintron_en.pdf"},
    {"id":"17470","name":"Agenda - European Medicines Agency-industry stakeholders platform meeting on paediatric medicines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-05-11T17:10:00Z","last_updated_date":"2015-05-22T17:00:00Z","reference_number":"EMA/265165/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-industry-stakeholders-platform-meeting-paediatric-medicines_en.pdf"},
    {"id":"17472","name":"Invented Name Review Group 2005-2006 - Zaide Frias","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-09-11T02:09:21Z","last_updated_date":"2006-09-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/invented-name-review-group-2005-2006-zaide-frias_en.pdf"},
    {"id":"17474","name":"Presentation - EMA Clinical Data Publication (CDP) - EMA's PCWP and HCPWP joint meeting (Karen Quigley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-clinical-data-publication-cdp-emas-pcwp-and-hcpwp-joint-meeting-karen-quigley_en.pdf"},
    {"id":"17475","name":"Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Carbaglu (carglumic acid) for the treatment of isovaleric acidaemia, methylmalonic acidaemia...","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-10-10T15:32:00Z","last_updated_date":"2021-06-09T15:05:00Z","reference_number":"EMA/COMP/321680/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-addition-new-indications-marketing-authorisation-carbaglu-carglumic-acid-treatment-isovaleric-acidaemia-methylmalonic-acidaemia_en.pdf"},
    {"id":"17477","name":"Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-07-08T02:00:00Z","last_updated_date":"2010-07-08T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/587488/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-quality-non-clinical-and-clinical-issues-related-development-recombinant-adeno-associated-viral-vectors_en.pdf"},
    {"id":"17478","name":"Presentation - An inspector’s perspective – Considerations for patient-support and reimbursement programmes (Anya Sookoo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T02:00:00Z","last_updated_date":"2013-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-inspectors-perspective-considerations-patient-support-and-reimbursement-programmes-anya-sookoo_en.pdf"},
    {"id":"17479","name":"EU/3/08/581: Public summary of positive opinion for orphan designation of ofatumumab for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMEA/COMP/480244/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308581-public-summary-positive-opinion-orphan-designation-ofatumumab-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"17480","name":"Presentation - How we communicate the outcome of safety reviews (M. Benstetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-we-communicate-outcome-safety-reviews-m-benstetter_en.pdf"},
    {"id":"17483","name":"Asparaginase: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00003161/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-15T02:00:00Z","last_updated_date":"2016-10-17T19:40:10Z","reference_number":"EMA/407533/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/asparaginase-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00003161201508_en.pdf"},
    {"id":"17484","name":"Day 80 assessment report generics overview template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-26T00:09:21Z","last_updated_date":"2015-02-20T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-80-assessment-report-generics-overview-template_en.doc"},
    {"id":"17485","name":"Background review for cyclodextrins used as excipients: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T18:20:00Z","last_updated_date":"2014-12-01T18:20:00Z","reference_number":"EMA/CHMP/333892/2013","document_url":"https://www.ema.europa.eu/en/documents/report/background-review-cyclodextrins-used-excipients-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-draft-report_en.pdf"},
    {"id":"17487","name":"Presentation - Substance, Product, Organisation and Referential (SPOR) impacts on processes","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-product-organisation-and-referential-spor-impacts-processes_en.pdf"},
    {"id":"17489","name":"Hydrochlorothiazide, spironolactone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001662/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T01:00:00Z","last_updated_date":"2016-10-17T17:35:00Z","reference_number":"EMA/739537/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-spironolactone-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001662201501_en.pdf"},
    {"id":"17493","name":"EU/3/17/1881: Public summary of opinion on orphan designation: Decitabine and tetrahydrouridine for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/324973/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171881-public-summary-opinion-orphan-designation-decitabine-and-tetrahydrouridine-treatment-sickle-cell-disease_en.pdf"},
    {"id":"17496","name":"Sorbitan sesquioleate: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-04-01T02:00:00Z","last_updated_date":"2004-04-01T02:00:00Z","reference_number":"EMEA/MRL/900/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sorbitan-sesquioleate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17497","name":"Scenesse recommended for rare disease that causes intolerance to sunlight","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/638997/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/scenesse-recommended-rare-disease-causes-intolerance-sunlight_en.pdf"},
    {"id":"17499","name":"List of participants - Spinal muscular atrophy stakeholder workshop","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"EMA/790303/2016","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-spinal-muscular-atrophy-stakeholder-workshop_en.pdf"},
    {"id":"17500","name":"Application for marketing authorisation form – from transferrer to transferee","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-11-30T01:00:00Z","last_updated_date":"2017-11-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-marketing-authorisation-form-transferrer-transferee_en.docx"},
    {"id":"17502","name":"Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VII – Periodic safety update report (Rev 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-12T11:00:00Z","last_updated_date":"2013-12-12T11:00:00Z","reference_number":"EMA/646427/2013","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-module-vii-periodic-safety-update-report-rev-1_en.pdf"},
    {"id":"17503","name":"Draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-03-22T01:00:00Z","last_updated_date":"2007-03-22T01:00:00Z","reference_number":"EMEA/CHMP/SWP/28367/2007 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-first-man-clinical-trials-potential-high-risk-medicinal-products-first-version_en.pdf"},
    {"id":"17505","name":"Presentation - Topic Group Academia, Learned Societies and HCP organisations proposals (how to move forward) (Rosa Giuliani, Sergio Bonini)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T02:00:00Z","last_updated_date":"2016-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-group-academia-learned-societies-and-hcp-organisations-proposals-how-move-forward-rosa-giuliani-sergio-bonini_en.pdf"},
    {"id":"17506","name":"Technical note on the planned EudraVigilance downtime from 8 to 21 November 2017","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-04T15:30:00Z","last_updated_date":"2017-10-04T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-note-planned-eudravigilance-downtime-8-21-november-2017_en.pdf"},
    {"id":"17508","name":"Final assessment report on Plantago ovata Forskk., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T15:30:00Z","last_updated_date":"2013-07-23T15:30:00Z","reference_number":"EMA/HMPC/304360/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-plantago-ovata-forskk-semen_en.pdf"},
    {"id":"17509","name":"15th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-07-24T02:00:00Z","last_updated_date":"2001-07-24T02:00:00Z","reference_number":"EMEA/COMP/286/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/15th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"17510","name":"Involvement of patients in CHMP benefit-risk (J. Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/involvement-patients-chmp-benefit-risk-j-garcia_en.pdf"},
    {"id":"17511","name":"EU/3/15/1583: Public summary of opinion on orphan designation: 2-Amino-2-[2-[2-chloro-4-[[3-(phenylmethoxy)phenyl]thio]phenyl]ethyl]-1,3-propanediol hydrochloride for the prevention of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2018-01-22T01:00:00Z","reference_number":"EMA/COMP/791411/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151583-public-summary-opinion-orphan-designation-2-amino-2-2-2-chloro-4-3-phenylmethoxyphenylthiophenylethyl-13-propanediol-hydrochloride-prevention-graft-versus-host-disease_en.pdf"},
    {"id":"17512","name":"Review of flupirtine-containing medicines started","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMA/695352/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-flupirtine-containing-medicines-started_en.pdf"},
    {"id":"17513","name":"CVMP summary of positive opinion for Nexgard Spectra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-07T01:00:00Z","last_updated_date":"2014-11-07T01:00:00Z","reference_number":"EMA/CVMP/641766/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-nexgard-spectra_en.pdf"},
    {"id":"17515","name":"VICH GL45: Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products - At step 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-02-18T01:00:00Z","last_updated_date":"2008-02-18T01:00:00Z","reference_number":"EMEA/CVMP/VICH/581467/2007-CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl45-bracketing-and-matrixing-designs-stability-testing-new-veterinary-drug-substances-and-medicinal-products-step-4_en.pdf"},
    {"id":"17518","name":"Presentation - Regulatory interactions: Expectations on extrapolation approaches (Lynne Yao)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-interactions-expectations-extrapolation-approaches-lynne-yao_en.pdf"},
    {"id":"17519","name":"Presentation - Road map to 2015: High-level overview of the outcome of the public consultation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-road-map-2015-high-level-overview-outcome-public-consultation_en.pdf"},
    {"id":"17521","name":"Note for guidance on inclusion of antioxidants and antimicrobial preservatives in medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-07-08T02:00:00Z","last_updated_date":"1997-07-08T02:00:00Z","reference_number":"CPMP/CVMP/QWP /115/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-inclusion-antioxidants-and-antimicrobial-preservatives-medicinal-products_en.pdf"},
    {"id":"17523","name":"Table of recommendations – Cystic fibrosis workshop","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"EMA/511310/2017","document_url":"https://www.ema.europa.eu/en/documents/other/table-recommendations-cystic-fibrosis-workshop_en.pdf"},
    {"id":"17526","name":"CPMP position statement: dopaminergic substances and sudden sleep onset","type":"position","status":"unknown","consultation_date":"","first_published_date":"2002-02-28T01:00:00Z","last_updated_date":"2002-02-28T01:00:00Z","reference_number":"CPMP/578/02 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/position/cpmp-position-statement-dopaminergic-substances-and-sudden-sleep-onset_en.pdf"},
    {"id":"17527","name":"Guidelines and concept papers adopted at the CHMP meeting 18-21 November 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-11-27T12:25:00Z","last_updated_date":"2013-11-27T12:25:00Z","reference_number":"EMA/710490/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-chmp-meeting-18-21-november-2013_en.pdf"},
    {"id":"17528","name":"Fifth report on the interaction with patients' and consumers' organisations (2011)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2012-10-10T14:00:00Z","last_updated_date":"2012-10-10T14:00:00Z","reference_number":"EMA/507517/2012","document_url":"https://www.ema.europa.eu/en/documents/report/fifth-report-interaction-patients-and-consumers-organisations-2011_en.pdf"},
    {"id":"17529","name":"Scientific recommendation on classification of advanced therapy medicinal products: Haematopoietic stem cells genetically modified to express a zinc finger nuclease which disrupts the enhancer of BCL11A expression","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/35484/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-haematopoietic-stem-cells-genetically-modified-express-zinc-finger-nuclease-which-disrupts-enhancer-bcl11a-expression_en.pdf"},
    {"id":"17530","name":"Agenda - CAT agenda of the 21-22 January 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-01-21T16:00:00Z","last_updated_date":"2016-01-21T16:00:00Z","reference_number":"EMA/CAT/49183/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-21-22-january-2016-meeting_en.pdf"},
    {"id":"17533","name":"Deltanil - Article 33 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/deltanil-article-33-referral-annex-i-ii-iii_is.pdf"}},
    {"id":"17535","name":"Agenda - EMA expert meeting on genome editing technologies used in medicinal product development","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T02:00:00Z","last_updated_date":"2018-07-19T02:00:00Z","reference_number":"EMA/359806/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-expert-meeting-genome-editing-technologies-used-medicinal-product-development_en.pdf"},
    {"id":"17536","name":"Carmustine (implant): List of nationally authorised medicinal products - PSUSA/00010348/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-10-18T15:41:12Z","reference_number":"EMA/375083/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/carmustine-implant-list-nationally-authorised-medicinal-products-psusa00010348201509_en.pdf"},
    {"id":"17537","name":"Presentation - Adverse-drug-reaction reporting – United Kingdom view (Mick Foy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adverse-drug-reaction-reporting-united-kingdom-view-mick-foy_en.pdf"},
    {"id":"17538","name":"Concept paper on requirements for multi-strain dossiers - First version","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-04-23T02:00:00Z","last_updated_date":"2007-04-23T02:00:00Z","reference_number":"EMEA/CVMP/IWP/90459/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-requirements-multi-strain-dossiers-first-version_en.pdf"},
    {"id":"17539","name":"CVMP post authorisation positive summary of opinion for Advocate","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-07-16T02:00:00Z","last_updated_date":"2010-07-16T02:00:00Z","reference_number":"EMEA/CVMP/401633/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-positive-summary-opinion-advocate_en.pdf"},
    {"id":"17541","name":"Ceftibuten: List of nationally authorised medicinal products - PSUSA/00000611/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-15T18:11:00Z","last_updated_date":"2018-03-15T18:15:54Z","reference_number":"EMA/168151/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ceftibuten-list-nationally-authorised-medicinal-products-psusa00000611201707_en.pdf"},
    {"id":"17542","name":"EU/3/16/1738: Public summary of positive opinion for orphan designation of 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide for the treatment of invasive a...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/628404/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161738-public-summary-positive-opinion-orphan-designation-2-15-dimethyl-3-phenyl-1h-pyrrol-2-yl-n-4-4-5-fluoro-pyrimidin-2-ylpiperazin-1-yl-phenyl-2-oxo-acetamide-treatment-invasive_en.pdf"},
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    {"id":"17546","name":"Module 01 - Presentation - Introduction to the EU Regulatory Network: Transparency, Trust and Reliance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-14T01:00:00Z","last_updated_date":"2017-11-14T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/module-01-presentation-introduction-eu-regulatory-network-transparency-trust-and-reliance_en.pdf"},
    {"id":"17547","name":"Report on the implementation of the European Medicines Agency-European Network for Health Technology Assessment (EUnetHTA) three-year work plan 2012-2015","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-14T13:00:00Z","last_updated_date":"2016-04-14T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-implementation-european-medicines-agency-european-network-health-technology-assessment-eunethta-three-year-work-plan-2012-2015_en.pdf"},
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    {"id":"17553","name":"Presentation - Session 2: European Medicines Agency consultation meeting on the rheumatoid arthritis guideline (Arantxa Sancho-Là³pez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-09T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-european-medicines-agency-consultation-meeting-rheumatoid-arthritis-guideline-arantxa-sancho-la3pez_en.pdf"},
    {"id":"17554","name":"European Medicines Agency’s Management Board endorses work programme 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T11:30:00Z","last_updated_date":"2013-12-17T11:30:00Z","reference_number":"EMA/783177/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-endorses-work-programme-2014_en.pdf"},
    {"id":"17555","name":"8th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-12-21T00:00:00Z","last_updated_date":"2000-12-21T00:00:00Z","reference_number":"EMEA/COMP/271/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/8th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"17557","name":"Priorix - Article 30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-19T02:00:00Z","last_updated_date":"2012-06-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/priorix-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/priorix-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/priorix-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/priorix-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/priorix-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/priorix-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/priorix-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/priorix-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/priorix-article-30-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/priorix-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/priorix-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/priorix-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/priorix-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/priorix-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/priorix-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/priorix-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/priorix-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/priorix-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/priorix-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/priorix-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/priorix-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/priorix-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"17559","name":"Overview of comments received on draft 'Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals' (E...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-07-27T14:46:00Z","last_updated_date":"2018-07-27T14:46:00Z","reference_number":"EMA/CVMP/AWP/598285/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-assessment-risk-public-health-antimicrobial-resistance-due-use-antimicrobial-veterinary-medicinal-product-food-producing-animals-e_en.pdf"},
    {"id":"17561","name":"Questions and answers on the referral for Loratadine Sandoz 10 loratadine 10 mg tablets - Final","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-12-12T00:08:21Z","last_updated_date":"2009-12-12T00:08:21Z","reference_number":"EMEA/CHMP/563259/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-loratadine-sandoz-10-loratadine-10-mg-tablets-final_sv.pdf"}},
    {"id":"17563","name":"Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-29T13:24:56Z","last_updated_date":"2012-06-29T13:24:56Z","reference_number":"CPMP/EWP/1080/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-or-prevention-diabetes-mellitus-revision-1_en.pdf"},
    {"id":"17565","name":"Minutes of the European Medicines Agency - Payer Community meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-12-06T17:27:00Z","last_updated_date":"2017-12-06T17:27:00Z","reference_number":"EMA/615275/2017 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-payer-community-meeting_en.pdf"},
    {"id":"17570","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (Portugal, Czech Republic)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-portugal-czech-republic_en.pdf"},
    {"id":"17575","name":"Presentation - Network's perspective - What networks can offer (Kalle Hoppu, FINPEDMED)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-networks-perspective-what-networks-can-offer-kalle-hoppu-finpedmed_en.pdf"},
    {"id":"17576","name":"Overview of comments received on the 'Reflection paper on anthelmintic resistance’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T16:25:00Z","last_updated_date":"2017-04-24T16:51:00Z","reference_number":"EMA/CVMP/EWP/526298/2016-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-anthelmintic-resistance_en.pdf"},
    {"id":"17577","name":"Presentation - Enpr-EMA work group on clinical trial preparedness (A. Siapkara)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-work-group-clinical-trial-preparedness-siapkara_en.pdf"},
    {"id":"17578","name":"Technical specifications for service concession - Procurement procedure EMA/2014/35/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T15:00:00Z","last_updated_date":"2015-03-04T13:56:00Z","reference_number":"EMA/430052/2014","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-service-concession-procurement-procedure-ema201435re_en.pdf"},
    {"id":"17581","name":"Altrenogest: Summary Report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-12-01T01:00:00Z","last_updated_date":"1999-12-01T01:00:00Z","reference_number":"EMEA/MRL/175/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/altrenogest-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17582","name":"CHMP summary of positive opinion for Benepali","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"EMA/CHMP/693863/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-benepali_en.pdf"},
    {"id":"17584","name":"Presentation - Proposals for strengthening the interaction between PDCO and PRAC (Benjamin Pelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposals-strengthening-interaction-between-pdco-and-prac-benjamin-pelle_en.pdf"},
    {"id":"17586","name":"Annual report of the European Medicines Agency 2006","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2007-05-01T02:00:00Z","last_updated_date":"2007-05-01T02:00:00Z","reference_number":"EMEA/MB/24167/2007/EN/FINAL","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2006_en.pdf"},
    {"id":"17587","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - PRAC list of questions to be addressed by stakeholders","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T17:00:00Z","last_updated_date":"2013-02-11T17:00:00Z","reference_number":"EMA/PRAC/78185/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-prac-list-questions-be-addressed-stakeholders_en.pdf"},
    {"id":"17588","name":"CHMP post-authorisation summary of positive opinion for TachoSil","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/147980/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tachosil_en.pdf"},
    {"id":"17589","name":"CHMP post-authorisation summary of positive opinion for Komboglyze","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T14:00:00Z","last_updated_date":"2017-05-19T14:00:00Z","reference_number":"EMA/CHMP/301707/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-komboglyze_en.pdf"},
    {"id":"17591","name":"Boric acid and borates: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-14T02:00:00Z","last_updated_date":"1996-05-14T02:00:00Z","reference_number":"EMEA/CVMP/025/MRL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/boric-acid-and-borates-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17592","name":"Ancillary - Day 150 JAR Overview template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:25:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-150-jar-overview-template-rev1016_en.doc"},
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    {"id":"17600","name":"Presentation - Overview of methodologies and studies evaluating risk minimisation measures (Giampiero Mazzaglia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-methodologies-and-studies-evaluating-risk-minimisation-measures-giampiero-mazzaglia_en.pdf"},
    {"id":"17602","name":"Advanced therapy medicinal products - Key figures in 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-14T10:30:00Z","last_updated_date":"2014-02-14T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/advanced-therapy-medicinal-products-key-figures-2013_en.pdf"},
    {"id":"17603","name":"EU/3/08/586): Public summary of positive opinion for orphan designation of RNA, [P-deoxy-P-(dimethylamino)](2',3'-dideoxy-2',3'-imino-2',3'-seco) (2'a→5')(C-m5U-C-C-A-A-C-A-m5U-C-A-A-G-G-A-A-G-A-m5U-G-G-C-A-m5U-m5U-m5U...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/567030/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308586-public-summary-positive-opinion-orphan-designation-rna-p-deoxy-p-dimethylamino23-dideoxy-23-imino-23-seco-2aa5c-m5u-c-c-c-m5u-c-g-g-g-m5u-g-g-c-m5u-m5u-m5u_en.pdf"},
    {"id":"17604","name":"Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-02-02T11:35:00Z","last_updated_date":"2012-02-02T11:35:00Z","reference_number":"EMA/CHMP/37646/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-pharmacogenetic-methodologies-pharmacokinetic-evaluation-medicinal-products_en.pdf"},
    {"id":"17606","name":"EU/3/15/1557: Public summary of opinion on orphan designation: Sirolimus for the treatment of tuberous sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-18T11:00:00Z","last_updated_date":"2015-11-18T11:00:00Z","reference_number":"EMA/COMP/608871/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151557-public-summary-opinion-orphan-designation-sirolimus-treatment-tuberous-sclerosis_en.pdf"},
    {"id":"17608","name":"Update from the European Medicines Agency on COX-2 inhibitors","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-01-20T00:09:21Z","last_updated_date":"2005-01-20T00:09:21Z","reference_number":"EMEA/23547/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-european-medicines-agency-cox-2-inhibitors_en.pdf"},
    {"id":"17609","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 23-26 June 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-07-01T16:30:00Z","last_updated_date":"2014-07-01T16:30:00Z","reference_number":"EMA/125338/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-during-chmp-meeting-23-26-june-2014_en.pdf"},
    {"id":"17610","name":"EU/3/13/1108: Public summary of opinion on orphan designation:\n\n2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-05T02:00:00Z","last_updated_date":"2013-04-05T02:00:00Z","reference_number":"EMA/COMP/86745/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131108-public-summary-opinion-orphan-designation-2-4-methoxy-3-2-m-tolyl-ethoxy-benzoylamino-indan-2-carboxylic-acid-treatment-systemic-sclerosis_en.pdf"},
    {"id":"17613","name":"EU/3/01/057: Public summary of positive opinion for orphan designation of porcine lung surfactant for treatment of acute lung injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-06-01T02:00:00Z","last_updated_date":"2005-06-01T02:00:00Z","reference_number":"EMEA/COMP/255/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301057-public-summary-positive-opinion-orphan-designation-porcine-lung-surfactant-treatment-acute-lung-injury_en.pdf"},
    {"id":"17614","name":"CVMP post-authorisation summary of positive opinion for Meloxidyl","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-01-15T00:09:21Z","last_updated_date":"2010-01-15T00:09:21Z","reference_number":"EMA/CVMP/826131/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-meloxidyl_en.pdf"},
    {"id":"17617","name":"Factor VIII Article-31 referral - PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-05-05T18:30:00Z","last_updated_date":"2017-06-09T02:00:00Z","reference_number":"EMA/153837/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-prac-concludes-there-no-clear-and-consistent-evidence-difference-inhibitor-development-between-classes-factor-viii-medicines_en.pdf"},
    {"id":"17618","name":"Presentation - Extrapolation framework: status quo and issues to be resolved (C. Male)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-framework-status-quo-and-issues-be-resolved-c-male_en.pdf"},
    {"id":"17619","name":"Ivermectin  - Article 35 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-10-27T00:59:00Z","last_updated_date":"2009-10-27T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ivermectin-article-35-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"17620","name":"Guideline on procedures for the granting of a marketing authorisation under exceptional circumstances, pursuant to article 14 (8) of Regulation (EC) No 726/2004","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-12-15T01:00:00Z","last_updated_date":"2005-12-15T01:00:00Z","reference_number":"EMEA/357981/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-procedures-granting-marketing-authorisation-under-exceptional-circumstances-pursuant-article-14-8-regulation-ec-no-7262004_en.pdf"},
    {"id":"17621","name":"Codeine Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2015-02-16T16:25:00Z","reference_number":"EMA/PRAC/180087/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"17622","name":"Apramycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-09-01T02:00:00Z","last_updated_date":"1997-09-01T02:00:00Z","reference_number":"EMEA/MRL/181/97","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/apramycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17624","name":"Agenda - PRAC draft agenda of meeting 8-11 February 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-02-08T18:00:00Z","last_updated_date":"2016-02-08T18:00:00Z","reference_number":"EMA/PRAC/94187/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-february-2016_en.pdf"},
    {"id":"17625","name":"Template - Translations required with the submission of  an application for transfer of orphan medicinal product designation","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:00Z","last_updated_date":"2022-10-06T13:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-translations-required-submission-application-transfer-orphan-medicinal-product-designation_en.doc"},
    {"id":"17627","name":"Presentation - Scientific advisory group meetings 'pilot phase' report","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advisory-group-meetings-pilot-phase-report_en.pdf"},
    {"id":"17629","name":"Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-04-19T19:00:00Z","last_updated_date":"2018-08-30T19:00:00Z","reference_number":"EMA/242738/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-paediatric-strategy-forum-medicinal-product-development-checkpoint-inhibitors-use-combination-therapy-paediatric-patients_en.pdf"},
    {"id":"17630","name":"New recommendations to minimise risks of the rare brain infection PML and a type of skin cancer with Gilenya","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/688187/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-recommendations-minimise-risks-rare-brain-infection-pml-and-type-skin-cancer-gilenya_en.pdf"},
    {"id":"17631","name":"Guideline for the conduct of efficacy studies for non steroidal anti inflammatory drugs","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-12-01T01:00:00Z","last_updated_date":"2001-12-01T01:00:00Z","reference_number":"EMEA/CVMP/237/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs_en.pdf-0"},
    {"id":"17636","name":"Presentation - The European reference networks: a vision from inside (Maurizio Scarpa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-reference-networks-vision-inside-maurizio-scarpa_en.pdf"},
    {"id":"17637","name":"Guideline on the Core SPC for Human Plasma Coagulation Factor VII Products (CPMP/BPWG/2048/01)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-07-29T02:00:00Z","last_updated_date":"2004-07-29T02:00:00Z","reference_number":"CPMP/BPWG/2048/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-plasma-coagulation-factor-vii-products-cpmpbpwg204801_en.pdf"},
    {"id":"17638","name":"Draft community herbal monograph on Aesculus hippocastanum L., semen","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/225319/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-aesculus-hippocastanum-l-semen_en.pdf"},
    {"id":"17640","name":"CHMP post-authorisation summary of positive opinion for Imbruvica","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/CHMP/284604/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imbruvica_en.pdf-0"},
    {"id":"17645","name":"Presentation - Towards increased engagement through social media. \n\nEMA’s current experience and way forward with social media (Sophie Labbe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-towards-increased-engagement-through-social-media-emas-current-experience-and-way-forward-social-media-sophie-labbe_en.pdf"},
    {"id":"17648","name":"Agenda - PRAC draft agenda of meeting 23-26 October 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-10-23T19:50:00Z","last_updated_date":"2017-10-23T19:50:00Z","reference_number":"EMA/PRAC/707172/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-23-26-october-2017_en.pdf"},
    {"id":"17649","name":"Table B: Materials from animals other than those included in the scope of the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-06-19T02:09:21Z","last_updated_date":"2009-06-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/table-b-materials-animals-other-those-included-scope-note-guidance-minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-medicinal-products_en.doc"},
    {"id":"17652","name":"Final assessment report on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-10-13T11:40:00Z","last_updated_date":"2011-10-13T11:40:00Z","reference_number":"EMA/HMPC/131735/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-viola-tricolor-l-andor-subspecies-viola-arvensis-murray-gaud-and-viola-vulgaris-koch-oborny-herba-cum-flore_en.pdf"},
    {"id":"17655","name":"Project description - Detailed information about the Instrument for Pre-accession Assistance transition assistance programme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-01T01:00:00Z","last_updated_date":"2008-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/project-description-detailed-information-about-instrument-pre-accession-assistance-transition-assistance-programme_en.pdf"},
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    {"id":"17663","name":"Public statement on Rienso (ferumoxytol): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-07-13T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMA/437901/2015","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-rienso-ferumoxytol-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"17664","name":"Methysergide Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-27T02:00:00Z","last_updated_date":"2014-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methysergide-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methysergide-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methysergide-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methysergide-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methysergide-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methysergide-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methysergide-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methysergide-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methysergide-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methysergide-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methysergide-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methysergide-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methysergide-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methysergide-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methysergide-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methysergide-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methysergide-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methysergide-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methysergide-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methysergide-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methysergide-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methysergide-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methysergide-article-31-referral-annex-i_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/methysergide-article-31-referral-annex-i_no.pdf"}},
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    {"id":"17670","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-04-29T14:45:00Z","last_updated_date":"2014-04-29T14:45:00Z","reference_number":"EMA/HPC/695912/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
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    {"id":"17672","name":"Iodocasein/thiamine-containing medicinal products-Article 107 referral-Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-i_en.pdf"},
    {"id":"17673","name":"EU/3/07/433: Public summary of positive opinion for orphan designation of HLA class I/II binding tumour associated peptides (ADF-APO-CCN-GUC-K67-MET-MMP-MUC-RGS) for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2016-10-20T02:00:00Z","reference_number":"EMEA/COMP/96943/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307433-public-summary-positive-opinion-orphan-designation-hla-class-iii-binding-tumour-associated-peptides-adf-apo-ccn-guc-k67-met-mmp-muc-rgs-treatment-renal-cell-carcinoma_en.pdf"},
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    {"id":"17683","name":"Summary of transfer of appropriations in the budget 2014 - Management Board meeting: 12 June 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-19T14:30:00Z","last_updated_date":"2014-06-19T14:30:00Z","reference_number":"EMA/MB/268686/2014 Noted","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2014-management-board-meeting-12-june-2014_en.pdf"},
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    {"id":"17694","name":"Procedural announcements, CHMP meeting 19-22 September 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/768879/2011","document_url":"https://www.ema.europa.eu/en/documents/other/procedural-announcements-chmp-meeting-19-22-september-2011_en.pdf"},
    {"id":"17695","name":"Cefacetrile: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-05-01T02:00:00Z","last_updated_date":"2001-05-01T02:00:00Z","reference_number":"EMEA/MRL/784/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefacetrile-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17696","name":"Finalisation of the European Medicines Agency policy on publication of and access to clinical trial data – Targeted consultation with key stakeholders - Summary report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-10-02T19:00:00Z","last_updated_date":"2014-10-02T19:00:00Z","reference_number":"EMA/292746/2014","document_url":"https://www.ema.europa.eu/en/documents/report/finalisation-european-medicines-agency-policy-publication-and-access-clinical-trial-data-targeted-consultation-key-stakeholders-summary-report_en.pdf"},
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    {"id":"17700","name":"Carboprost: List of nationally authorised medicinal products - PSUSA/00000560/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-10-18T15:41:10Z","reference_number":"EMA/599288/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/carboprost-list-nationally-authorised-medicinal-products-psusa00000560201601_en.pdf"},
    {"id":"17701","name":"EU/3/05/268: Public summary of positive opinion for orphan designation of (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3H-indol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysyccina...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2016-09-30T02:00:00Z","reference_number":"EMEA/COMP/216937/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305268-public-summary-positive-opinion-orphan-designation-z-n-2-diethylaminoethyl-5-5-fluoro-2-oxo-12-dihydro-3h-indol-3-ylidenemethyl-24-dimethyl-1h-pyrrole-3-carboxamide-s-2-hydroxysyccina_en.pdf"},
    {"id":"17702","name":"Valebo and associated names Article-29(4) referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-31T03:00:00Z","last_updated_date":"2014-03-31T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valebo-and-associated-names-article-294-referral-assessment-report_en.pdf"},
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    {"id":"17705","name":"The EU clinical trial portal and database","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2016-09-23T13:20:00Z","last_updated_date":"2016-09-23T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/eu-clinical-trial-portal-and-database_en.pdf"},
    {"id":"17706","name":"CVMP summary of positive opinion for Semintra","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"EMA/CVMP/734548/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-semintra_en.pdf"},
    {"id":"17711","name":"Agenda - European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting on 4 June 2015","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-05-27T13:00:00Z","last_updated_date":"2015-09-01T13:00:00Z","reference_number":"EMA/272606/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting-4-june-2015_en.pdf"},
    {"id":"17712","name":"Organisational matters - CHMP meeting 12-15 March 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-20T15:00:00Z","last_updated_date":"2012-03-20T15:00:00Z","reference_number":"EMA/CHMP/162996/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-12-15-march-2012_en.pdf"},
    {"id":"17713","name":"Sarafloxacin (salmonidae): Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-23T02:00:00Z","last_updated_date":"1996-05-23T02:00:00Z","reference_number":"EMEA/MRL/349/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sarafloxacin-salmonidae-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"17715","name":"Presentation - Evolving framework for the co-development of medicinal products with companion diagnostics (Falk Ehmann and Armin Ritzhaupt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:16:00Z","last_updated_date":"2018-06-06T17:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evolving-framework-co-development-medicinal-products-companion-diagnostics-falk-ehmann-and-armin-ritzhaupt_en.pdf"},
    {"id":"17717","name":"2014 annual report on EudraVigilance for the European Parliament, the Council and the Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T14:03:00Z","last_updated_date":"2015-05-04T14:03:00Z","reference_number":"EMA/23619/2015","document_url":"https://www.ema.europa.eu/en/documents/report/2014-annual-report-eudravigilance-european-parliament-council-and-commission_en.pdf"},
    {"id":"17721","name":"Regranex - Product information as approved by the CHMP on 18 February 2010, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-18T01:00:00Z","last_updated_date":"2010-02-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/regranex-product-information-approved-chmp-18-february-2010-pending-endorsement-european-commission_en.pdf"},
    {"id":"17722","name":"Minutes of the EMA Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting - 4 June 2015","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-09-01T02:00:00Z","last_updated_date":"2015-09-01T02:00:00Z","reference_number":"EMA/377881/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting-4-june-2015_en.pdf"},
    {"id":"17724","name":"Draft guideline on clinical investigation of medicinal products for the treatment of ankylosing spondylitis - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-06-23T02:00:00Z","last_updated_date":"2005-06-23T02:00:00Z","reference_number":"CPMP/EWP/4891/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-ankylosing-spondylitis-first-version_en.pdf"},
    {"id":"17725","name":"Restrictions on use of short-acting beta-agonists in obstetric indications – CMDh endorses PRAC recommendations","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T14:10:00Z","last_updated_date":"2013-10-25T14:10:00Z","reference_number":"EMA/565019/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/restrictions-use-short-acting-beta-agonists-obstetric-indications-cmdh-endorses-prac-recommendations_sv.pdf"}},
    {"id":"17727","name":"Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-05T16:30:00Z","last_updated_date":"2017-09-05T16:30:00Z","reference_number":"EMA/580033/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/sertindole-list-nationally-authorised-medicinal-products-psusa00002695201701_en.pdf"},
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    {"id":"17741","name":"Workshop on endpoints for cystic fibrosis clinical trials - Call for expression of interest","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-02T14:00:00Z","last_updated_date":"2012-07-02T14:00:00Z","reference_number":"EMA/385817/2012","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-endpoints-cystic-fibrosis-clinical-trials-call-expression-interest_en.pdf"},
    {"id":"17742","name":"Successful Rijeka conference strengthens EU-Croatian cooperation on medicines regulation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-18T00:09:21Z","last_updated_date":"2008-11-18T00:09:21Z","reference_number":"EMEA/605819/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/successful-rijeka-conference-strengthens-eu-croatian-cooperation-medicines-regulation_en.pdf"},
    {"id":"17745","name":"Brimonidine (except for the centrally authorised product): List of nationally authorised medicinal products - PSUSA/00000430/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-14T19:00:00Z","last_updated_date":"2017-06-14T19:00:00Z","reference_number":"EMA/366180/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/brimonidine-except-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa00000430201609_en.pdf"},
    {"id":"17747","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products -Meeting of 19 to 21 November 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-11-21T01:00:00Z","last_updated_date":"2002-11-21T01:00:00Z","reference_number":"EMEA/CPMP/5802/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-19-21-november-2002_en.pdf"},
    {"id":"17752","name":"Presentation - Manufacturing process of biologics, Kowid Ho, Afssaps","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-manufacturing-process-biologics-kowid-ho-afssaps_en.pdf"},
    {"id":"17756","name":"EU/3/13/1141: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against the keratin 6a N171K mutation for the treatment of pachyonychia congenita","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T14:00:00Z","last_updated_date":"2013-07-30T14:00:00Z","reference_number":"EMA/COMP/318074/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131141-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-keratin-6a-n171k-mutation-treatment-pachyonychia-congenita_en.pdf"},
    {"id":"17757","name":"Declaration of interests: Noel Wathion","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:00Z","last_updated_date":"2020-09-03T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-noel-wathion_en.pdf"},
    {"id":"17759","name":"Implementation of recommendations by the CVMP on prudent use guidance - Liisa Kaartinen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/implementation-recommendations-cvmp-prudent-use-guidance-liisa-kaartinen_en.pdf"},
    {"id":"17760","name":"EU Medicines Agencies Network Strategy to 2020: Working together to improve health","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/MB/151414/2015","document_url":"https://www.ema.europa.eu/en/documents/other/eu-medicines-agencies-network-strategy-2020-working-together-improve-health_en.pdf"},
    {"id":"17761","name":"Agenda for the 68th meeting of the Management Board","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/MB/398075/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-68th-meeting-management-board_en.pdf"},
    {"id":"17762","name":"Presentation - Orphan drug designation in the European Union (Stiina Aarum)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orphan-drug-designation-european-union-stiina-aarum_en.pdf"},
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    {"id":"17768","name":"Presentation - Current involvement of European Medicines Agency in research and development and future perspectives (Marco Cavaleri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-involvement-european-medicines-agency-research-and-development-and-future-perspectives-marco-cavaleri_en.pdf"},
    {"id":"17771","name":"Tylvalosin (eggs): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-09-08T16:35:00Z","last_updated_date":"2015-09-08T16:35:00Z","reference_number":"EMA/CVMP/380628/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tylvalosin-eggs-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"17773","name":"Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 157 to 169","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-10-02T19:00:00Z","last_updated_date":"2014-10-02T19:00:00Z","reference_number":"EMA/354914/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-publication-and-access-clinical-trial-data-ema2408102013-stakeholder-157-169_en.pdf"},
    {"id":"17774","name":"Comments received from public consultation on good pharmacovigilance practices (GVP) module X – Additional monitoring","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-25T12:00:00Z","last_updated_date":"2013-04-25T12:00:00Z","reference_number":"EMA/239763/2013","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-module-x-additional-monitoring_en.pdf"},
    {"id":"17775","name":"Toltrazuril (extension to cattle and extrapolation to all mammalian food-producing species and poultry): Summary Report (5) – Committee for Medicinal Products for Veterinary use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-09-01T02:00:00Z","last_updated_date":"2005-09-01T02:00:00Z","reference_number":"EMEA/CVMP/278616/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/toltrazuril-extension-cattle-and-extrapolation-all-mammalian-food-producing-species-and-poultry-summary-report-5-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"17776","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: SomaKit TOC (edotreotide) for the diagnosis of gastroenteropancreatic neuroendocrine tumours","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2017-02-20T17:00:00Z","last_updated_date":"2017-02-20T17:00:00Z","reference_number":"EMA/683386/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-somakit-toc-edotreotide-diagnosis-gastroenteropancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"17777","name":"Presentation - Focus on immunogenicity of FVIII and FIX products and general reflections on registries (H. Marijke van den Berg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-immunogenicity-fviii-and-fix-products-and-general-reflections-registries-h-marijke-van-den-berg_en.pdf"},
    {"id":"17778","name":"Press Release : Entacapone (Comtess, Comtan) - Update of product information","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-11-23T01:00:00Z","last_updated_date":"1998-11-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-entacapone-comtess-comtan-update-product-information_en.pdf"},
    {"id":"17779","name":"Matching patients-friendly therapeutic areas for browse search on herbal medicines for human use with ATC therapeutic groups (level 2)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-06-28T02:00:00Z","last_updated_date":"2016-03-08T16:45:00Z","reference_number":"EMA/568320/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/matching-patients-friendly-therapeutic-areas-browse-search-herbal-medicines-human-use-atc-therapeutic-groups-level-2_en.pdf"},
    {"id":"17781","name":"Draft list of references for assessment of: Verbasci flos Verbascum Sp., flos (mullein flower)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/395238/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-verbasci-flos-verbascum-sp-flos-mullein-flower_en.pdf"},
    {"id":"17782","name":"CHMP post-authorisation summary of positive opinion for Faslodex","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"EMA/675100/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-faslodex_en.pdf"},
    {"id":"17784","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 12 –15 September 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/CHMP/SAWP/604222/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-12-15-september-2016_en.pdf"},
    {"id":"17785","name":"European Medicines Agency concludes that benefit-risk balance of Revlimid remains positive","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T13:00:00Z","last_updated_date":"2011-09-23T13:00:00Z","reference_number":"EMA/CHMP/767843/2011 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-benefit-risk-balance-revlimid-remains-positive_en.pdf"},
    {"id":"17786","name":"Annual report of the European Agency for Evaluation of Medicinal Products 2001","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2001-12-18T00:09:21Z","last_updated_date":"2001-12-18T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_es.pdf","da":"https://www.ema.europa.eu/da/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_da.pdf","de":"https://www.ema.europa.eu/de/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_de.pdf","el":"https://www.ema.europa.eu/el/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_fr.pdf","it":"https://www.ema.europa.eu/it/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/annual-report/annual-report-european-agency-evaluation-medicinal-products-2001_sv.pdf"}},
    {"id":"17787","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-04-09T19:30:00Z","last_updated_date":"2014-04-09T19:30:00Z","reference_number":"EMA/156949/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-march-2014_en.pdf"},
    {"id":"17788","name":"Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-12-04T11:28:00Z","last_updated_date":"2017-12-04T11:28:00Z","reference_number":"EMA/INS/GMP/131704/2017","document_url":"https://www.ema.europa.eu/en/documents/report/annual-report-good-manufacturing-and-distribution-practice-inspectors-working-group-2016_en.pdf"},
    {"id":"17789","name":"CHMP positive summary of opinion for Ruconest","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2010-06-25T02:00:00Z","reference_number":"EMA/CHMP/380794/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-ruconest_en.pdf"},
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    {"id":"17792","name":"EU/3/02/105: Public summary of positive opinion for orphan designation of carbamic acid, [[4-[[3-[[4-[1-(4-hydroxyphenyl)-1-methylethyl]\n\nphenoxy]methyl]phenyl]methoxy]-phenyl]iminomethyl]-,ethyl ester (amelubant)\n\nfor t...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T00:00:00Z","last_updated_date":"2005-11-29T00:00:00Z","reference_number":"EMEA/COMP/1071/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302105-public-summary-positive-opinion-orphan-designation-carbamic-acid-4-3-4-1-4-hydroxyphenyl-1-methylethyl-phenoxymethylphenylmethoxy-phenyliminomethyl-ethyl-ester-amelubant-t_en.pdf"},
    {"id":"17794","name":"Presentation - Innovative Medicines Initiative (IMI) (Salah-Dine Chibout)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-innovative-medicines-initiative-imi-salah-dine-chibout_en.pdf"},
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    {"id":"17802","name":"Registration form - European Medicines Agency/International Federation for Animal Health Europe info day 2016","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-12-21T01:00:00Z","last_updated_date":"2015-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-european-medicines-agencyinternational-federation-animal-health-europe-info-day-2016_en.doc"},
    {"id":"17804","name":"Committee for Proprietary Medicinal Products (CPMP) 41st plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-09-21T02:00:00Z","last_updated_date":"1998-09-21T02:00:00Z","reference_number":"CPMP/2010/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-41st-plenary-meeting_en.pdf"},
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    {"id":"17809","name":"Final assessment report on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-04-29T14:45:00Z","last_updated_date":"2014-04-29T14:45:00Z","reference_number":"EMA/HPC/283629/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
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    {"id":"17814","name":"Diclazuril: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-04-01T02:00:00Z","last_updated_date":"1996-04-01T02:00:00Z","reference_number":"EMEA/MRL/086/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diclazuril-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17815","name":"Oxynal, Targin Article-13 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-27T17:15:00Z","last_updated_date":"2015-01-27T17:15:00Z","reference_number":"EMA/707185/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/oxynal-targin-article-13-referral-assessment-report_en.pdf"},
    {"id":"17818","name":"Presentation - Public-health burden of medication errors and how this might be addressed through the European Union pharmacovigilance system (David Cousins)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-health-burden-medication-errors-and-how-might-be-addressed-through-european-union-pharmacovigilance-system-david-cousins_en.pdf"},
    {"id":"17820","name":"Guideline on clinical investigation of medicinal products for the treatment of Sepsis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"CHMP/EWP/4713/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-sepsis_en.pdf"},
    {"id":"17821","name":"Substances related to nicotinic acid Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-13T18:00:00Z","last_updated_date":"2014-03-13T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/substances-related-nicotinic-acid-article-31-referral-annex-iii_sv.pdf"}},
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    {"id":"17826","name":"Joint audit programme for EEA GMP inspectorates: Programme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-19T02:00:00Z","last_updated_date":"2020-07-31T11:00:00Z","reference_number":"EMA/618050/2015 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-eea-gmp-inspectorates-programme_en.pdf"},
    {"id":"17830","name":"Tafluprost / timolol: List of nationally authorised medicinal products - PSUSA/00010324/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T12:50:00Z","last_updated_date":"2018-07-19T12:50:00Z","reference_number":"EMA/497430/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/tafluprost-timolol-list-nationally-authorised-medicinal-products-psusa00010324201712_en.pdf"},
    {"id":"17831","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human monocytes-derived suppressive cells, expanded ex vivo","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T19:00:00Z","last_updated_date":"2016-04-04T19:00:00Z","reference_number":"EMA/557288/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-monocytes-derived-suppressive-cells-expanded-ex-vivo_en.pdf"},
    {"id":"17833","name":"Assessment report for Simvastatin Vale and associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T02:00:00Z","last_updated_date":"2013-07-22T02:00:00Z","reference_number":"EMA/264659/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-simvastatin-vale-and-associated-names_en.pdf"},
    {"id":"17835","name":"CHMP summary of positive opinion for Kanjinti","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T10:33:00Z","last_updated_date":"2018-03-23T10:33:00Z","reference_number":"EMA/CHMP/22098/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kanjinti_en.pdf"},
    {"id":"17836","name":"EU/3/12/990: Public summary of opinion on orphan designation: Vosaroxin for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:55:00Z","last_updated_date":"2012-06-18T16:55:00Z","reference_number":"EMA/COMP/222562/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312990-public-summary-opinion-orphan-designation-vosaroxin-treatment-acute-myeloid-leukaemia_en.pdf"},
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    {"id":"17842","name":"Final opinion of the HMPC on a European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-07-03T02:00:00Z","last_updated_date":"2018-07-03T02:00:00Z","reference_number":"EMA/HMPC/195629/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizome-revision-1_en.pdf"},
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    {"id":"17850","name":"Imidocarb: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/444/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/imidocarb-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"17854","name":"Ex ante publicity of a negotiated procedure – EMA/2016/58/COM – Scientific, Technical and Medical eBooks","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-10-10T12:00:00Z","last_updated_date":"2016-10-10T12:00:00Z","reference_number":"EMA/439870/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201658com-scientific-technical-and-medical-ebooks_en.pdf"},
    {"id":"17855","name":"Draft assessment report on Hypericum perforatum L., herba - Revision 1","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2018-03-08T01:00:00Z","last_updated_date":"2018-03-08T01:00:00Z","reference_number":"EMA/HMPC/244315/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-hypericum-perforatum-l-herba-revision-1_en.pdf"},
    {"id":"17860","name":"Overview of comments received on ‘Draft Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use’ (EMA/CHMP/BPWP/319619/2005 Rev. 2)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-09-29T12:00:00Z","last_updated_date":"2016-09-29T12:00:00Z","reference_number":"EMA/CHMP/BPWP/379278/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-core-smpc-human-anti-d-immunoglobulin-intravenous-use-emachmpbpwp3196192005-rev-2_en.pdf"},
    {"id":"17862","name":"Requirements for the first In-Human clinical trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/requirements-first-human-clinical-trials_en.pdf"},
    {"id":"17863","name":"CHMP summary of positive opinion for Aubagio","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/379992/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aubagio_en.pdf"},
    {"id":"17866","name":"Scientific recommendation on classification of advanced therapy medicinal products: Sterile suspension of autologous cells of stromal vascular fraction of adipose tissue in Lactated Ringers solution","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T12:45:00Z","last_updated_date":"2016-04-12T12:45:00Z","reference_number":"EMA/213724/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-sterile-suspension-autologous-cells-stromal-vascular-fraction-adipose-tissue-lactated-ringers-solution_en.pdf-0"},
    {"id":"17867","name":"CHMP ORGAM agenda for the meeting on 4 September 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-09-12T19:07:00Z","last_updated_date":"2017-09-12T19:07:00Z","reference_number":"EMA/CHMP/581740/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-4-september-2017_en.pdf"},
    {"id":"17868","name":"INS-GCP-3 procedure for conducting GCP inspections requested by the EMEA","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2007-09-20T02:00:00Z","reference_number":"EMEA/INS/GCP/197223/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ins-gcp-3-procedure-conducting-gcp-inspections-requested-emea_en.pdf"},
    {"id":"17874","name":"ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-07-01T02:00:00Z","last_updated_date":"2003-07-01T02:00:00Z","reference_number":"CPMP/ICH/2887/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-4-e-common-technical-document-registration-pharmaceuticals-human-use-efficacy-step-5_en.pdf"},
    {"id":"17875","name":"Superseded overview of comments received on Community Herbal Monograph on Melissa officinalis L., folium (EMEA/HMPC/5341/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2013-08-05T02:00:00Z","reference_number":"EMEA/HMPC/499295/2007 Corr","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-melissa-officinalis-l-folium-emeahmpc53412007_en.pdf"},
    {"id":"17877","name":"European Medicines Agency informs doctors and patients about drug interaction between Victrelis and ritonavir-boosted HIV protease inhibitors","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T17:07:13Z","last_updated_date":"2012-02-16T17:07:13Z","reference_number":"EMA/CHMP/119622/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-informs-doctors-and-patients-about-drug-interaction-between-victrelis-and-ritonavir-boosted-hiv-protease-inhibitors_en.pdf"},
    {"id":"17879","name":"Agenda - Second EMA-EFPIA annual bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-07-07T17:45:00Z","last_updated_date":"2017-07-07T17:45:00Z","reference_number":"EMA/426082/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-ema-efpia-annual-bilateral-meeting_en.pdf"},
    {"id":"17880","name":"EU/3/08/549: Public summary of positive opinion for orphan designation of NGR-human tumour necrosis factor for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/185263/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308549-public-summary-positive-opinion-orphan-designation-ngr-human-tumour-necrosis-factor-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"17883","name":"European Union enlargement programme","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2013-03-25T11:30:00Z","last_updated_date":"2013-05-22T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/european-union-enlargement-programme_en.pdf"},
    {"id":"17884","name":"Committee for Proprietary Medical Products: 24-25 april 2001 meeting (summary)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-05-04T02:09:21Z","last_updated_date":"2001-05-04T02:09:21Z","reference_number":"CPMP/1262/01 corr.","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medical-products-24-25-april-2001-meeting-summary_en.pdf"},
    {"id":"17888","name":"Presentation - Federation of Veterinarians of Europe (FVE): Impact on public and animal health of the use of antibiotics in animals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-federation-veterinarians-europe-fve-impact-public-and-animal-health-use-antibiotics-animals_en.pdf"},
    {"id":"17891","name":"Mercaptamine hydrochloride: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-11-01T01:00:00Z","last_updated_date":"1998-11-01T01:00:00Z","reference_number":"EMEA/MRL/518/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/mercaptamine-hydrochloride-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17893","name":"Renin-angiotensin-system (RAS)-acting agents Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T02:00:00Z","last_updated_date":"2014-03-07T14:43:00Z","reference_number":"EMA/PRAC/290691/2013 rev. 3","document_url":"https://www.ema.europa.eu/en/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"17895","name":"EU/3/11/925: Public summary of opinion on orphan designation: Mifepristone for the treatment of hypercortisolism (Cushing’s syndrome) of endogenous origin","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/COMP/793876/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311925-public-summary-opinion-orphan-designation-mifepristone-treatment-hypercortisolism-cushings-syndrome-endogenous-origin_en.pdf"},
    {"id":"17896","name":"CHMP post-authorisation summary of positive opinion for Eylea","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/568489/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-eylea_en.pdf-0"},
    {"id":"17897","name":"COMP meeting report on the review of applications for orphan designation: May 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-06-14T12:00:00Z","last_updated_date":"2018-06-14T12:00:00Z","reference_number":"EMA/COMP/270019/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-may-2018_en.pdf"},
    {"id":"17898","name":"EU/3/05/297: Public summary of positive opinion for orphan designation of adeno-associated viral vector containing modified U7 snRNA gene for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-11T02:00:00Z","last_updated_date":"2005-10-11T02:00:00Z","reference_number":"EMEA/COMP/203896/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305297-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-containing-modified-u7-snrna-gene-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"17901","name":"Public statement on the use of herbal medicinal products containing thujone - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-02-20T13:00:00Z","last_updated_date":"2012-06-29T14:13:00Z","reference_number":"EMA/HMPC/732886/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-use-herbal-medicinal-products-containing-thujone-revision-1_en.pdf"},
    {"id":"17904","name":"Guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-11-01T01:00:00Z","last_updated_date":"2008-11-01T01:00:00Z","reference_number":"EMEA/CHMP/GTWP/125491/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-requirements-environmental-risk-assessment-gene-therapy-medicinal-products_en.pdf"},
    {"id":"17905","name":"Stem cell-based medicinal products as ATMPs in the EU: Dr Paula Salmikangas","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/stem-cell-based-medicinal-products-atmps-eu-dr-paula-salmikangas_en.pdf"},
    {"id":"17907","name":"Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-03-01T18:00:00Z","last_updated_date":"2013-03-01T18:00:00Z","reference_number":"EMA/130601/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/tackling-medication-errors-european-medicines-agency-workshop-calls-coordinated-eu-approach_en.pdf"},
    {"id":"17910","name":"Xefo - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-09-28T02:08:21Z","last_updated_date":"2007-09-28T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/xefo-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/xefo-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/xefo-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/xefo-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/xefo-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/xefo-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/xefo-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/xefo-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/xefo-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/xefo-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/xefo-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/xefo-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/xefo-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/xefo-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/xefo-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/xefo-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/xefo-article-30-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/xefo-article-30-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/xefo-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/xefo-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/xefo-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/xefo-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"17914","name":"Ivabradine /metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T12:44:00Z","last_updated_date":"2016-12-02T12:48:38Z","reference_number":"EMA/810188/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivabradine-metoprolol-list-nationally-authorised-medicinal-products-psusa00010381201604_en.pdf"},
    {"id":"17916","name":"Acetylisovaleryltylosin: Summary Report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-10-01T02:00:00Z","last_updated_date":"1999-10-01T02:00:00Z","reference_number":"EMEA/MRL/702/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/acetylisovaleryltylosin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"17919","name":"Presentation - Product information management - Annex: Example package leaflet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-information-management-annex-example-package-leaflet_en.pdf"},
    {"id":"17920","name":"Final European Union herbal monograph on Carum carvi L., aetheroleum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/HMPC/715094/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-carum-carvi-l-aetheroleum_en.pdf"},
    {"id":"17921","name":"Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00003065/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T15:35:00Z","last_updated_date":"2018-04-19T15:45:00Z","reference_number":"EMA/230850/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/aciclovir-hydrocortisone-list-nationally-authorised-medicinal-products-psusa00003065201708_en.pdf"},
    {"id":"17922","name":"Glucomed - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-12-21T00:08:21Z","last_updated_date":"2006-12-21T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/glucomed-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"17925","name":"EU/3/12/1064: Public summary of opinion on orphan designation: Alisertib for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2017-02-07T17:38:00Z","reference_number":"EMA/COMP/663000/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121064-public-summary-opinion-orphan-designation-alisertib-treatment-ovarian-cancer_en.pdf"},
    {"id":"17927","name":"Evaluation of degradation studies of veterinary drugs in manures - A regulatory viewpoint - Joop de Knecht","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:09:21Z","last_updated_date":"2009-06-23T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/evaluation-degradation-studies-veterinary-drugs-manures-regulatory-viewpoint-joop-de-knecht_en.pdf"},
    {"id":"17929","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-01-12T18:00:01Z","last_updated_date":"2018-01-12T18:00:01Z","reference_number":"EMA/CAT/830803/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-december-2017_en.pdf"},
    {"id":"17930","name":"Ergot derivatives Article-31 referral - Dihydroergotamine - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotamine-annex-iv_sv.pdf"}},
    {"id":"17931","name":"EU/3/11/871: Public summary of opinion on orphan designation: Salirasib for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2017-10-19T02:00:00Z","reference_number":"EMA/COMP/227845/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311871-public-summary-opinion-orphan-designation-salirasib-treatment-pancreatic-cancer_en.pdf"},
    {"id":"17932","name":"Guideline on core SmPC for human fibrinogen products\n\n(EMEA/CHMP/BPWP/122007/2005)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/CHMP/BPWP/122007/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-human-fibrinogen-products-emeachmpbpwp1220072005_en.pdf"},
    {"id":"17934","name":"Public statement on Zinbryta: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T12:20:01Z","last_updated_date":"2018-05-02T12:20:01Z","reference_number":"EMA/247897/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zinbryta-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"17935","name":"EU/3/14/1381: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human MD1 gene for treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2015-01-16T01:00:00Z","reference_number":"EMA/COMP/660615/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141381-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-md1-gene-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"17936","name":"Presentation - Professionalisation and representativeness among civil-society representatives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-professionalisation-and-representativeness-among-civil-society-representatives_en.pdf"},
    {"id":"17939","name":"Overview of the Procedure and interactions between CAT and CHMP - Marie-Helene Pinheiro","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-procedure-and-interactions-between-cat-and-chmp-marie-helene-pinheiro_en.pdf"},
    {"id":"17940","name":"Presentation - Challenges and concerns implementing SPOR - Industry perspective - The voice of the animal medicines industry and European Group for Generic Veterinary Products (EGGVP) - Substance, product, organisation a...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-27T01:00:00Z","last_updated_date":"2018-02-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-and-concerns-implementing-spor-industry-perspective-voice-animal-medicines-industry-and-european-group-generic-veterinary-products-eggvp-substance-product-organisation_en.pdf"},
    {"id":"17941","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Tobramycin for treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T11:30:00Z","last_updated_date":"2014-10-21T11:30:00Z","reference_number":"EMA/511537/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-tobramycin-treatment-pseudomonas-aeruginosa-pulmonary-infection-colonisation-patients-cystic-fibrosis_en.pdf"},
    {"id":"17945","name":"Questions and answers on the withdrawal of the marketing authorisation application for Balimek (binimetinib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-03-27T17:07:00Z","reference_number":"EMA/41972/2018","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-balimek-binimetinib_sv.pdf"}},
    {"id":"17946","name":"Committee for Medicinal Products for Human Use (CHMP) - May 2006 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-06-14T02:00:00Z","last_updated_date":"2006-06-14T02:00:00Z","reference_number":"EMEA/209537/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-may-2006-plenary-meeting-monthly-report_en.pdf"},
    {"id":"17948","name":"CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats - meeting 2 outcome with comments and amendments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag2-advice-european-medicines-agency-clinical-trial-advisory-group-clinical-trial-data-formats-meeting-2-outcome-comments-and-amendments_en.pdf"},
    {"id":"17950","name":"Presentation - ERNs and research: state of play from the European Commission\n\nperspective (Helene Le Borgne)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-erns-and-research-state-play-european-commission-perspective-helene-le-borgne_en.pdf"},
    {"id":"17952","name":"CHMP summary of positive opinion for Kadcyla","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/572965/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kadcyla_en.pdf"},
    {"id":"17953","name":"PDCO meeting highlights 17-19 September 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-09-24T02:00:00Z","last_updated_date":"2008-09-24T02:00:00Z","reference_number":"EMEA/PDCO/493761/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-17-19-september-2008_en.pdf"},
    {"id":"17954","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): GVP Module XVI Addendum I – Educational materials","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-15T12:30:00Z","last_updated_date":"2015-12-15T12:30:00Z","reference_number":"EMA/772528/2015","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-module-xvi-addendum-i-educational-materials_en.pdf"},
    {"id":"17956","name":"Questions and answers on boric acid and borates used as excipients in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/619104/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-boric-acid-and-borates-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"17957","name":"The Common Technical Document- Quality (CTD-Q) - George Wade","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/common-technical-document-quality-ctd-q-george-wade_en.pdf"},
    {"id":"17958","name":"Withdrawal assessment report for Aflunov","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-12-19T01:00:00Z","last_updated_date":"2008-12-19T01:00:00Z","reference_number":"EMEA/540171/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-aflunov_en.pdf"},
    {"id":"17959","name":"General comments received from public consultation on good pharmacovigilance practices","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T19:18:21Z","last_updated_date":"2012-06-25T19:18:21Z","reference_number":"EMA/428590/2012","document_url":"https://www.ema.europa.eu/en/documents/other/general-comments-received-public-consultation-good-pharmacovigilance-practices_en.pdf"},
    {"id":"17960","name":"CHMP summary of positive opinion for Opdivo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T02:00:00Z","last_updated_date":"2015-04-24T02:00:00Z","reference_number":"EMA/CHMP/76686/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-opdivo_en.pdf"},
    {"id":"17962","name":"VICH GL40: Test procedures and acceptance criteria for new biotechnological/ biological veterinary medicinal products - At step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-15T01:00:00Z","last_updated_date":"2005-11-15T01:00:00Z","reference_number":"EMEA/CVMP/VICH/811/04-corrig.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl40-test-procedures-and-acceptance-criteria-new-biotechnological-biological-veterinary-medicinal-products-step-7_en.pdf"},
    {"id":"17964","name":"Superseded assessment report on Vitis vinifera L., folium - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/16633/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-vitis-vinifera-l-folium-first-version_en.pdf"},
    {"id":"17966","name":"Human medicines highlights - December 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2016-01-15T15:10:00Z","last_updated_date":"2016-01-15T15:10:00Z","reference_number":"Issue 82","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-december-2015_en.pdf"},
    {"id":"17967","name":"Opinion of the Committee on Herbal Medicinal Products on a European Union herbal monograph on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/HMPC/711682/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-european-union-herbal-monograph-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"17970","name":"Committee for Advanced Therapies (CAT) work programme 2010 - 2015","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CAT/235374/2010","document_url":"https://www.ema.europa.eu/en/documents/work-programme/committee-advanced-therapies-cat-work-programme-2010-2015_en.pdf"},
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    {"id":"18013","name":"Presentation - Manufacturing of gene-therapy products: common issues and advice","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-manufacturing-gene-therapy-products-common-issues-and-advice_en.pdf"},
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    {"id":"18020","name":"Guidance for the template for the qualified person’s declaration concerning good manufacturing practice (GMP) compliance of active substance manufacture “The QP declaration template”","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-06-04T12:10:00Z","last_updated_date":"2014-06-04T12:10:00Z","reference_number":"EMA/196292/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-template-qualified-persons-declaration-concerning-good-manufacturing-practice-gmp-compliance-active-substance-manufacture-qp-declaration-template_en.pdf"},
    {"id":"18021","name":"Presentation - Big data and the new European Union data protection Regulation: the role of big data in healthcare (Sophie Louveaux)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-and-new-european-union-data-protection-regulation-role-big-data-healthcare-sophie-louveaux_en.pdf"},
    {"id":"18022","name":"Withdrawal assessment report for Retisert","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/CHMP/412692/2007","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-retisert_en.pdf"},
    {"id":"18023","name":"EU/3/01/055: Public summary of positive opinion for orphan designation of cladribine (subcutaneous use) for the treatment of indolent non-Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T00:00:00Z","last_updated_date":"2014-06-19T01:00:00Z","reference_number":"EMEA/COMP/1317/03 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301055-public-summary-positive-opinion-orphan-designation-cladribine-subcutaneous-use-treatment-indolent-non-hodgkins-lymphoma_en.pdf"},
    {"id":"18027","name":"What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2017-04-11T19:30:00Z","last_updated_date":"2017-04-11T19:30:00Z","reference_number":"Issue 1 - 2017","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-1-2017_en.pdf"},
    {"id":"18028","name":"Template for the Cover Letter to submit data on Post-Authorisation Commitments","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-07-29T02:09:21Z","last_updated_date":"2009-07-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-cover-letter-submit-data-post-authorisation-commitments_en.doc"},
    {"id":"18031","name":"EU/3/16/1646: Public summary of opinion on orphan designation: Combination of 4-hydroxyandrostenedione, Serenoa serrulata fruit extract and alpha lipoic acid for the treatment of multiple symmetric lipomatosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-31T02:00:00Z","last_updated_date":"2016-05-31T02:00:00Z","reference_number":"EMA/COMP/242793/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161646-public-summary-opinion-orphan-designation-combination-4-hydroxyandrostenedione-serenoa-serrulata-fruit-extract-and-alpha-lipoic-acid-treatment-multiple-symmetric-lipomatosis_en.pdf"},
    {"id":"18033","name":"Committee for proprietary medicinal products January 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-01-24T01:00:00Z","last_updated_date":"2002-01-24T01:00:00Z","reference_number":"CPMP/197/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-january-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"18034","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"EMA/CVMP/778750/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-december-2017_en.pdf"},
    {"id":"18035","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - May 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-06-03T02:00:00Z","last_updated_date":"2010-06-03T02:00:00Z","reference_number":"EMA/CVMP/334379/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-may-2010_en.pdf"},
    {"id":"18036","name":"Presentation - International Federation for Animal Health global benchmarking survey 2011 (Barbara Freischem)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-federation-animal-health-global-benchmarking-survey-2011-barbara-freischem_en.pdf"},
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    {"id":"18039","name":"First EMEA workshop with industry on Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-04-25T02:00:00Z","last_updated_date":"2001-04-25T02:00:00Z","reference_number":"COMP/141/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-emea-workshop-industry-orphan-medicinal-products_en.pdf"},
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    {"id":"18042","name":"Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 18-20 May 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"EMA/CVMP/286802/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-18-20-may-2010_en.pdf"},
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    {"id":"18055","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T15:00:00Z","last_updated_date":"2013-06-10T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-i_no.pdf"}},
    {"id":"18057","name":"Tilmicosin (extension to turkey): Summary Report (6) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-12-01T00:09:21Z","last_updated_date":"2000-12-01T00:09:21Z","reference_number":"EMEA/MRL/764/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tilmicosin-extension-turkey-summary-report-6-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18060","name":"Draft list of references for assessment of Menthae piperitae aetheroleum\n\nMentha x piperita L. (peppermint oil)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2007-07-05T02:00:00Z","reference_number":"EMEA/HMPC/199469/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-menthae-piperitae-aetheroleum-mentha-x-piperita-l-peppermint-oil_en.pdf"},
    {"id":"18062","name":"General principles processing joint FDA EMEA Voluntary Genomic Data Submissions (VGDSs) within the framework of the confidentiality arrangement","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-04-01T02:00:00Z","last_updated_date":"2007-04-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/general-principles-processing-joint-fda-emea-voluntary-genomic-data-submissions-vgdss-within-framework-confidentiality-arrangement_en.pdf"},
    {"id":"18063","name":"Pre-submission checklist for annual renewal of conditional marketing authorisation applications","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T17:00:00Z","last_updated_date":"2016-10-07T17:00:00Z","reference_number":"EMA/198337/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/pre-submission-checklist-annual-renewal-conditional-marketing-authorisation-applications_en.pdf"},
    {"id":"18065","name":"Template - Active substance-master-file procedure","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-07-13T13:03:00Z","last_updated_date":"2021-03-23T12:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-active-substance-master-file-procedure_en.doc"},
    {"id":"18067","name":"EU/03/14/1277: Public summary of opinion on orphan designation of plasmid DNA encoding the human cystic fibrosis transmembrane conductance regulator gene complexed with a non-viral, cationic lipid based gene transfer age...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/255560/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu03141277-public-summary-opinion-orphan-designation-plasmid-dna-encoding-human-cystic-fibrosis-transmembrane-conductance-regulator-gene-complexed-non-viral-cationic-lipid-based-gene-transfer-age_en.pdf"},
    {"id":"18068","name":"Opinion of the HMPC on a European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-01-14T01:00:00Z","last_updated_date":"2016-01-14T01:00:00Z","reference_number":"EMA/HMPC/642021/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"18070","name":"Bradley Malin (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T16:00:00Z","last_updated_date":"2017-10-31T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/bradley-malin-cv_en.pdf"},
    {"id":"18072","name":"Work programme for the European Medicines Agency 2008","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2008-04-07T02:09:21Z","last_updated_date":"2008-04-07T02:09:21Z","reference_number":"EMEA/MB/487174/2007 Adopted","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-medicines-agency-2008_en.pdf"},
    {"id":"18073","name":"Opinion following an Article 33(4) referral for Norbonex 5 mg/ml pour-on solution for beef and dairy cattle","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/128538/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-norbonex-5-mgml-pour-solution-beef-and-dairy-cattle_sv.pdf"}},
    {"id":"18074","name":"EU/3/15/1481: Public summary of positive opinion for orphan designation of Phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis(1,1-dimethylethyl) monohydrochloride for the treatment of Huntington’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T14:00:00Z","last_updated_date":"2017-10-19T14:00:00Z","reference_number":"EMA/COMP/205588/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151481-public-summary-positive-opinion-orphan-designation-phenol-4-2-aminomethyl-4-thiazolyl-26-bis11-dimethylethyl-monohydrochloride-treatment-huntingtons-disease_en.pdf"},
    {"id":"18075","name":"Assessment of the paediatric needs - Epilepsy","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-09-20T02:00:00Z","last_updated_date":"2006-09-20T02:00:00Z","reference_number":"EMEA/377174/2006","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-epilepsy_en.pdf"},
    {"id":"18076","name":"List of questions: High-grade glioma expert meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-06T02:00:00Z","last_updated_date":"2011-07-06T02:00:00Z","reference_number":"EMA/608847/2010","document_url":"https://www.ema.europa.eu/en/documents/other/list-questions-high-grade-glioma-expert-meeting_en.pdf"},
    {"id":"18077","name":"Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"18079","name":"Presentation - Herbal summaries for the public - Involvement of  patients’ and consumers’ organisations’ in preparation of herbal summaries (Federica Castellani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T17:00:00Z","last_updated_date":"2013-07-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-herbal-summaries-public-involvement-patients-and-consumers-organisations-preparation-herbal-summaries-federica-castellani_en.pdf"},
    {"id":"18080","name":"CHMP statistics: June 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-statistics-june-2015_en.pdf"},
    {"id":"18081","name":"Introduction to quality assessment - Diana van Riet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-quality-assessment-diana-van-riet_en.pdf"},
    {"id":"18082","name":"Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation - January 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T16:51:02Z","last_updated_date":"2012-01-16T16:51:02Z","reference_number":"EMA/COMP/969544/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-meeting-report-review-applications-orphan-designation-january-2012_en.pdf"},
    {"id":"18083","name":"Presentation - Involvement of young people and families in Enpr-EMA networks (Benjamin Pelle, Peter Helms and Jenny Newman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involvement-young-people-and-families-enpr-ema-networks-benjamin-pelle-peter-helms-and-jenny-newman_en.pdf"},
    {"id":"18089","name":"Committee for medicinal products for human use, summary of positive opinion for Rivastigmine Sandoz","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/593097/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-rivastigmine-sandoz_en.pdf"},
    {"id":"18094","name":"Cetrimide: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-03-01T01:00:00Z","last_updated_date":"1996-03-01T01:00:00Z","reference_number":"EMEA/MRL/073/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cetrimide-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18095","name":"Presentation: 2009 report on the interaction with Patients’ and Consumers’ Organisations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-08-20T02:00:00Z","last_updated_date":"2010-08-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2009-report-interaction-patients-and-consumers-organisations_en.pdf"},
    {"id":"18097","name":"Final European Union herbal monograph on Calendula officinalis L., flos - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-06-14T15:00:00Z","last_updated_date":"2018-06-14T15:00:00Z","reference_number":"EMA/HMPC/437450/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-calendula-officinalis-l-flos-revision-1_en.pdf"},
    {"id":"18099","name":"D80 assessment report - Overview guidance rev.10.17","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-05-25T12:30:00Z","last_updated_date":"2017-12-05T12:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/d80-assessment-report-overview-guidance-rev1017_en.pdf"},
    {"id":"18100","name":"Committee for Orphan Medicinal Products: February 2006 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-02-08T01:00:00Z","last_updated_date":"2006-02-08T01:00:00Z","reference_number":"EMEA/COMP/49248/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-february-2006-meeting_en.pdf"},
    {"id":"18101","name":"Withdrawal assessment report for NovoNorm","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2006-12-14T01:00:00Z","last_updated_date":"2006-12-14T01:00:00Z","reference_number":"EMEA/CHMP/511689/2006","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-novonorm_en.pdf"},
    {"id":"18104","name":"EU/3/11/934: Public summary of opinion on orphan designation: 4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2018-02-22T01:00:00Z","reference_number":"EMA/COMP/870315/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311934-public-summary-opinion-orphan-designation-4-9-3s-tetrahydro-3-furanyl-8-246-trifluorophenylamino-9h-purin-2-ylamino-trans-cyclohexanol-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"18105","name":"Final assessment report on Vaccinium myrtillus L., fructus recens and Vaccinium myrtillus L., fructus siccus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"EMA/HMPC/555161/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-vaccinium-myrtillus-l-fructus-recens-and-vaccinium-myrtillus-l-fructus-siccus_en.pdf"},
    {"id":"18106","name":"EU/3/09/630: Public summary of positive opinion for orphan designation of skin equivalent graft genetically corrected with a COL7A1-encoding SIN retroviral vector for the treatment of dystrophic epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-12T02:00:00Z","last_updated_date":"2014-10-07T02:00:00Z","reference_number":"EMEA/COMP/148489/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309630-public-summary-positive-opinion-orphan-designation-skin-equivalent-graft-genetically-corrected-col7a1-encoding-sin-retroviral-vector-treatment-dystrophic-epidermolysis-bullosa_en.pdf"},
    {"id":"18108","name":"Presentation - The choice of outcome parameters and need for distinct assessment tools with regard to the different disease stages in Alzheimer’s disease (Iva Holmerovà¡)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-choice-outcome-parameters-and-need-distinct-assessment-tools-regard-different-disease-stages-alzheimers-disease-iva-holmerova_en.pdf"},
    {"id":"18111","name":"CHMP statistics: November 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-statistics-november-2015_en.pdf"},
    {"id":"18112","name":"Agenda - PRAC draft agenda of meeting 4-7 February 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-02-05T18:00:00Z","last_updated_date":"2013-02-05T18:00:00Z","reference_number":"EMA/PRAC/729256/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-4-7-february-2013_en.pdf"},
    {"id":"18113","name":"Committee for Medicinal Products for Veterinary Use: Meeting of 12-14 January 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-15T01:00:00Z","last_updated_date":"2010-01-15T01:00:00Z","reference_number":"EMA/CVMP/6072/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-12-14-january-2010_en.pdf"},
    {"id":"18114","name":"Overview of comments received on Guidance on collection and provision of national data on antimicrobial use by animal species/categories","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-02-23T15:07:00Z","last_updated_date":"2018-02-23T15:07:00Z","reference_number":"EMA/619729/2017","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guidance-collection-and-provision-national-data-antimicrobial-use-animal-speciescategories_en.pdf"},
    {"id":"18116","name":"Presentation - EMA/EGA workshop - Session 5 : Q&A on Other Important Topics (Susana Almeida, Grupo Tecnimede)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-5-qa-other-important-topics-susana-almeida-grupo-tecnimede_en.pdf"},
    {"id":"18117","name":"Hypericum perforatum (Use in veterinary homeopathy): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/690/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hypericum-perforatum-use-veterinary-homeopathy-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18120","name":"COMP meeting report on the review of applications for orphan designation: April 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-04-25T18:30:00Z","last_updated_date":"2017-04-25T18:30:00Z","reference_number":"MA/COMP/188861/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-april-2017_en.pdf"},
    {"id":"18121","name":"Agenda - Workshop on methods for efficacy studies in everyday medical practice - 24-25 October 2013","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-10-24T11:10:00Z","last_updated_date":"2013-11-27T11:20:00Z","reference_number":"EMA/607212/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-methods-efficacy-studies-everyday-medical-practice-24-25-october-2013_en.pdf"},
    {"id":"18122","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 25-28 January 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T10:45:00Z","last_updated_date":"2016-02-03T10:45:00Z","reference_number":"EMA/67219/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-25-28-january-2016_en.pdf"},
    {"id":"18124","name":"Overview of comments received on draft guideline on validation of immunoassay for the detection of hepatitis B virus surface antigen (HBSAG) in plasma pools","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-21T02:00:00Z","last_updated_date":"2006-09-21T02:00:00Z","reference_number":"EMEA/CHMP/BWP/94181/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-validation-immunoassay-detection-hepatitis-b-virus-surface-antigen-hbsag-plasma-pools_en.pdf"},
    {"id":"18126","name":"Presentation - Analytical Similarity Assessment (S-C. Chow, FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-analytical-similarity-assessment-s-c-chow-fda_en.pdf"},
    {"id":"18128","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 7-9 October 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-10-20T18:00:00Z","last_updated_date":"2015-10-20T18:00:00Z","reference_number":"EMA/PDCO/672645/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-7-9-october-2015_en.pdf"},
    {"id":"18129","name":"Questions and answers on the referral for Lescol and associated names Capsules containing 20 mg or 40 mg fluvastatin Prolonged-release tablets containing 80 mg 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    {"id":"18130","name":"CHMP summary of positive opinion for Capecitabine Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2012-02-17T01:00:00Z","reference_number":"EMA/CHMP/106696/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-capecitabine-accord_en.pdf"},
    {"id":"18132","name":"CHMP ORGAM agenda for the meeting on 10 April 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-04-10T11:55:00Z","last_updated_date":"2017-04-10T11:55:00Z","reference_number":"EMA/CHMP/206179/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-10-april-2017_en.pdf"},
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    {"id":"18135","name":"EU/3/06/353: Public summary of positive opinion for orphan designation\n\nof 26 base single stranded phosphodiester DNA oligonucleotide for the  treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMEA/COMP/25490/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306353-public-summary-positive-opinion-orphan-designation-26-base-single-stranded-phosphodiester-dna-oligonucleotide-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"18138","name":"Final European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T14:00:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/750269/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-revision-2_en.pdf"},
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    {"id":"18140","name":"Report on annual workshop of the European network of paediatric research at the  European Medicines Agency (Enpr-EMA) on 28 - 29 May 2015","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-08-05T13:30:00Z","last_updated_date":"2015-08-05T13:30:00Z","reference_number":"EMA/432711/2015","document_url":"https://www.ema.europa.eu/en/documents/report/report-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema-28-29-may-2015_en.pdf"},
    {"id":"18142","name":"Minutes of the 69th meeting of the Management Board: 16 December 2010","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2011-02-11T01:00:00Z","last_updated_date":"2011-02-11T01:00:00Z","reference_number":"EMA/MB/808316/2010 corr.","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_sk.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-69th-meeting-management-board-16-december-2010_sv.pdf"}},
    {"id":"18146","name":"Draft guideline on the clinical evaluation of direct acting antiviral agents intended for treatment of chronic Hepatitis C","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/30039/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-direct-acting-antiviral-agents-intended-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"18147","name":"European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T02:00:00Z","last_updated_date":"2013-04-30T02:00:00Z","reference_number":"EMA/271410/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-receives-interim-decisions-general-court-eu-access-clinical-and-non-clinical-information_en.pdf"},
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    {"id":"18152","name":"Committee for veterinary medicinal products: Meeting of 14 to 16 January 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-01-17T12:49:21Z","last_updated_date":"2003-01-17T12:49:21Z","reference_number":"EMEA/CVMP/071/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-14-16-january-2003_en.pdf"},
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    {"id":"18155","name":"Presentation - Making medicines affordable (Ana Maria Tomà©)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-making-medicines-affordable-ana-maria-tomac_en.pdf"},
    {"id":"18157","name":"EU-USA strategic meeting on the future of paediatric medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T13:30:00Z","last_updated_date":"2016-12-14T13:30:00Z","reference_number":"EMA/662807/2016","document_url":"https://www.ema.europa.eu/en/documents/report/eu-usa-strategic-meeting-future-paediatric-medicines_en.pdf"},
    {"id":"18158","name":"Opinion following an Article 31(2) referral for Etoricoxib containing medicinal products International Non-Proprietary Name (INN): etoricoxib: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:08:21Z","last_updated_date":"2008-10-23T02:08:21Z","reference_number":"EMEA/542169/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-312-referral-etoricoxib-containing-medicinal-products-international-non-proprietary-name-inn-etoricoxib-background-information_sv.pdf"}},
    {"id":"18159","name":"European Medicines Agency concludes on use of celecoxib in familial adenomatous polyposis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/384697/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-use-celecoxib-familial-adenomatous-polyposis_en.pdf"},
    {"id":"18162","name":"Our challenges in pain Management in Neonates - Vineta Fellman","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-10-28T02:09:21Z","last_updated_date":"2004-10-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/our-challenges-pain-management-neonates-vineta-fellman_en.pdf"},
    {"id":"18164","name":"EU/3/16/1721 : Public summary of opinion on orphan designation: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser for the prevention of graft loss in pancreatic islet transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161721-public-summary-opinion-orphan-designation-l-pyr-l-glu-l-gln-l-leu-l-glu-l-arg-l-ala-l-leu-l-asn-l-ser-l-ser-prevention-graft-loss-pancreatic-islet-transplantation_en.pdf"},
    {"id":"18165","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - September 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T16:30:00Z","last_updated_date":"2011-10-11T16:30:00Z","reference_number":"EMA/CVMP/777739/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-september-2011_en.pdf"},
    {"id":"18167","name":"Presentation - Field efficacy trials versus laboratory challenge experiments (E.  Thiry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:30:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-field-efficacy-trials-versus-laboratory-challenge-experiments-e-thiry_en.pdf"},
    {"id":"18169","name":"EU/3/14/1253: Public summary of opinion on orphan designation: Ex-vivo cultured human mesenchymal stromal cells for the prevention of graft rejection following solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-06T02:00:00Z","last_updated_date":"2014-05-06T02:00:00Z","reference_number":"EMA/COMP/90111/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141253-public-summary-opinion-orphan-designation-ex-vivo-cultured-human-mesenchymal-stromal-cells-prevention-graft-rejection-following-solid-organ-transplantation_en.pdf"},
    {"id":"18171","name":"Agenda - PRAC draft agenda of meeting 8-11 April 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-04-11T14:00:00Z","last_updated_date":"2013-04-11T14:00:00Z","reference_number":"EMA/218110/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-april-2013_en.pdf"},
    {"id":"18174","name":"Presentation - Phase 2a trial design is being planned: How does pharmacokinetic variation observed in phase I affect trial design?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-phase-2a-trial-design-being-planned-how-does-pharmacokinetic-variation-observed-phase-i-affect-trial-design_en.pdf"},
    {"id":"18175","name":"CHMP post-authorisation summary of positive opinion for Silgard","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2019-04-02T02:00:00Z","reference_number":"EMA/CHMP/243055/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-silgard_en.pdf"},
    {"id":"18176","name":"Eleutherococcus root - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-02-10T01:00:00Z","last_updated_date":"2016-02-10T01:00:00Z","reference_number":"EMA/283374/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/eleutherococcus-root-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/eleutherococcus-root-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/eleutherococcus-root-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/eleutherococcus-root-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/eleutherococcus-root-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/eleutherococcus-root-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/eleutherococcus-root-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/eleutherococcus-root-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/eleutherococcus-root-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/eleutherococcus-root-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/eleutherococcus-root-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/eleutherococcus-root-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/eleutherococcus-root-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/eleutherococcus-root-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/eleutherococcus-root-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/eleutherococcus-root-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/eleutherococcus-root-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/eleutherococcus-root-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/eleutherococcus-root-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/eleutherococcus-root-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/eleutherococcus-root-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/eleutherococcus-root-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/eleutherococcus-root-summary-public_sv.pdf"}},
    {"id":"18177","name":"Presentation - Variations and worksharing – regulatory perspective (Melanie Leivers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-variations-and-worksharing-regulatory-perspective-melanie-leivers_en.pdf"},
    {"id":"18180","name":"Twenty-fourth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-12-02T01:00:00Z","last_updated_date":"1999-12-02T01:00:00Z","reference_number":"EMEA/MB/075/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/twenty-fourth-meeting-management-board_en.pdf"},
    {"id":"18182","name":"Nanotop Article-29(4) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-16T17:00:00Z","last_updated_date":"2014-06-16T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nanotop-article-294-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nanotop-article-294-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nanotop-article-294-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nanotop-article-294-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nanotop-article-294-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nanotop-article-294-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nanotop-article-294-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nanotop-article-294-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nanotop-article-294-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nanotop-article-294-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nanotop-article-294-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nanotop-article-294-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nanotop-article-294-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nanotop-article-294-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nanotop-article-294-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nanotop-article-294-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nanotop-article-294-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nanotop-article-294-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nanotop-article-294-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nanotop-article-294-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nanotop-article-294-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nanotop-article-294-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nanotop-article-294-referral-annex-i_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/nanotop-article-294-referral-annex-i_no.pdf"}},
    {"id":"18184","name":"Withdrawal letter: Intrinsa","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-26T02:00:00Z","last_updated_date":"2010-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-intrinsa_en.pdf"},
    {"id":"18186","name":"Overview of comments received on draft guideline on guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-17T01:00:00Z","last_updated_date":"2008-11-17T01:00:00Z","reference_number":"EMEA/CVMP/IWP/521211/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-guideline-requirements-authorisation-under-exceptional-circumstances-vaccines-emergency-use-against-bluetongue_en.pdf"},
    {"id":"18187","name":"Draft list of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-07-23T02:00:00Z","last_updated_date":"2015-07-23T02:00:00Z","reference_number":"EMA/HMPC/150847/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-valeriana-officinalis-l-radix-and-valeriana-officinalis-l-aetheroleum_en.pdf-0"},
    {"id":"18188","name":"Kogenate Bayer and Helixate NexGen Article-20 procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-04-09T12:00:00Z","last_updated_date":"2014-04-09T12:00:00Z","reference_number":"EMA/10430/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-prac-assessment-report_en.pdf"},
    {"id":"18189","name":"Presentation - Assessing the probability of drug-induced QTc-interval prolongation during early clinical drug development - Break-out session 2 theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-assessing-probability-drug-induced-qtc-interval-prolongation-during-early-clinical-drug-development-break-out-session-2-theme-2_en.pdf"},
    {"id":"18192","name":"European Medicines Agency statement on Herceptin","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-09-22T02:00:00Z","last_updated_date":"2005-09-22T02:00:00Z","reference_number":"EMEA/312626/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-statement-herceptin_en.pdf"},
    {"id":"18193","name":"EMA recommends suspending the veterinary medicine Velactis used in dairy cows at the time of drying off","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-15T02:00:00Z","last_updated_date":"2016-07-15T02:00:00Z","reference_number":"EMA/484068/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-suspending-veterinary-medicine-velactis-used-dairy-cows-time-drying_en.pdf"},
    {"id":"18194","name":"CHMP summary of positive opinion for Levetiracetam Hospira","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-10-25T14:00:00Z","last_updated_date":"2013-10-25T14:00:00Z","reference_number":"EMA/443446/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-levetiracetam-hospira_en.pdf"},
    {"id":"18197","name":"Committee for Proprietary Medicinal Products (CPMP) 28th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-06-20T02:00:00Z","last_updated_date":"1997-06-20T02:00:00Z","reference_number":"CPMP/502/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-28th-plenary-meeting_en.pdf"},
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    {"id":"18199","name":"EU/3/13/1154: Public summary of opinion on orphan designation: Fosbretabulin tromethamine for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2021-09-02T14:30:00Z","reference_number":"EMA/COMP/417559/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131154-public-summary-opinion-orphan-designation-fosbretabulin-tromethamine-treatment-ovarian-cancer_en.pdf"},
    {"id":"18202","name":"Agenda - Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-02-19T13:00:00Z","last_updated_date":"2018-04-18T11:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-brexit-regulatory-preparedness-veterinary-medicinal-products-centralised-procedure_en.pdf"},
    {"id":"18204","name":"Template for the Letter of Undertaking (commitments undertaken by the Applicant/MAH)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-05-12T02:09:21Z","last_updated_date":"2009-05-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-letter-undertaking-commitments-undertaken-applicantmah_en.doc"},
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    {"id":"18210","name":"Codeine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2015-05-18T02:00:00Z","reference_number":"EMA/713187/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-i_en.pdf-1","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-annex-i_bg.pdf-0","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-annex-i_es.pdf-0","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-annex-i_cs.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-annex-i_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-annex-i_de.pdf-0","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-annex-i_et.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-annex-i_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-annex-i_fr.pdf-0","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-annex-i_hr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-annex-i_it.pdf-0","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-annex-i_lv.pdf-0","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-annex-i_lt.pdf-0","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-annex-i_hu.pdf-0","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-annex-i_mt.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-annex-i_nl.pdf-0","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-annex-i_pl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-annex-i_pt.pdf-0","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-annex-i_ro.pdf-0","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-annex-i_sk.pdf-0","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-annex-i_sl.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-annex-i_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-annex-i_sv.pdf-0"}},
    {"id":"18211","name":"Committee for veterinary medicinal products: 63rd meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-02-15T12:39:21Z","last_updated_date":"2001-02-15T12:39:21Z","reference_number":"EMEA/CVMP/207/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-63rd-meeting_en.pdf"},
    {"id":"18213","name":"EU/3/18/1972: Public summary of opinion on orphan designation: 1-[[[4-(4-fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropanamine-dihydrochloride for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/60711/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181972-public-summary-opinion-orphan-designation-1-4-4-fluoro-2-methyl-1h-indol-5-yloxy-6-methoxyquinolin-7-yloxymethylcyclopropanamine-dihydrochloride-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"18214","name":"Isotretinoin: List of nationally authorised medicinal products - PSUSA/00001795/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-10-20T18:50:42Z","reference_number":"EMA/60776/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/isotretinoin-list-nationally-authorised-medicinal-products-psusa00001795201505_en.pdf"},
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    {"id":"18220","name":"Tysabri Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-05-08T14:00:00Z","last_updated_date":"2015-05-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tysabri-article-20-procedure-notification_en.pdf"},
    {"id":"18221","name":"Flupirtine-containing medicines Article-107i procedure - Timetable for the procedure","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-08T13:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"EMA/PRAC/137732/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-timetable-procedure_en.pdf"},
    {"id":"18222","name":"Report from the PDCO on its first anniversary","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-07-11T02:00:00Z","last_updated_date":"2008-07-11T02:00:00Z","reference_number":"EMEA/PDCO/347884/2008","document_url":"https://www.ema.europa.eu/en/documents/report/report-pdco-its-first-anniversary_en.pdf"},
    {"id":"18224","name":"EU/3/09/703: Public summary of opinion on orphan designation of brivudine for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"EMA/COMP/768295/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309703-public-summary-opinion-orphan-designation-brivudine-treatment-pancreatic-cancer_en.pdf"},
    {"id":"18225","name":"Tiotropium: List of nationally authorised medicinal products - PSUSA/00002972/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-12T10:45:00Z","last_updated_date":"2017-06-12T11:05:46Z","reference_number":"EMA/356882/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tiotropium-list-nationally-authorised-medicinal-products-psusa00002972201610_en.pdf"},
    {"id":"18226","name":"Merck Serono Europe Limited withdraws its marketing authorisation application for Movectro (cladribine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-02-17T01:00:00Z","last_updated_date":"2011-02-17T01:00:00Z","reference_number":"EMA/112512/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/merck-serono-europe-limited-withdraws-its-marketing-authorisation-application-movectro-cladribine_en.pdf"},
    {"id":"18227","name":"First treatment recommended for rare bone disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/CHMP/422875/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-treatment-recommended-rare-bone-disease_en.pdf"},
    {"id":"18228","name":"24th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-05-23T02:09:21Z","last_updated_date":"2002-05-23T02:09:21Z","reference_number":"COMP/1051/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/24th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"18229","name":"CHMP post-authorisation summary of positive opinion for Abraxane","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2015-01-23T01:00:00Z","reference_number":"EMA/CHMP/42494/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abraxane_en.pdf"},
    {"id":"18231","name":"Lenograstim: List of nationally authorised medicinal products - PSUSA/00001839/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-08-25T12:00:00Z","last_updated_date":"2017-08-25T12:04:10Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/lenograstim-list-nationally-authorised-medicinal-products-psusa00001839201610_en.pdf"},
    {"id":"18232","name":"Procedural advice on the re-examination of CHMP opinions","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-02-12T01:00:00Z","last_updated_date":"2009-02-12T01:00:00Z","reference_number":"EMEA/CHMP/50745/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-re-examination-chmp-opinions_en.pdf"},
    {"id":"18234","name":"Final Community herbal monograph on Primula veris L. and / or Primula elatior (L.) Hill, flos","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T01:00:00Z","last_updated_date":"2013-03-04T01:00:00Z","reference_number":"EMA/HMPC/136582/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-primula-veris-l-and-or-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"18235","name":"Hydroxyethyl starch Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T15:30:00Z","last_updated_date":"2013-11-15T15:30:00Z","reference_number":"EMA/667674/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"18236","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Curcuma longa L., rhizoma - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-02-04T01:00:00Z","last_updated_date":"2010-02-04T01:00:00Z","reference_number":"EMEA/HMPC/678921/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-curcuma-longa-l-rhizoma-first-version_en.pdf"},
    {"id":"18238","name":"Declaration of interests: Stiina Aarum","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-16T11:30:00Z","last_updated_date":"2013-10-16T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-stiina-aarum_en.pdf"},
    {"id":"18239","name":"Draft community herbal monograph on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-05-08T02:09:21Z","last_updated_date":"2007-05-08T02:09:21Z","reference_number":"EMEA/HMPC/260019/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"18240","name":"Questions and answers on the review of Conbriza (bazedoxifene), PecFent (fentanyl) and Torisel (temsirolimus)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T17:02:17Z","last_updated_date":"2012-07-20T17:02:17Z","reference_number":"EMA/483755/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-conbriza-bazedoxifene-pecfent-fentanyl-and-torisel-temsirolimus_en.pdf"},
    {"id":"18243","name":"EU/3/16/1813: Public summary of opinion on orphan designation: Autologous dendritic cells incubated ex vivo with zebularine and factor VIII for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/5825/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161813-public-summary-opinion-orphan-designation-autologous-dendritic-cells-incubated-ex-vivo-zebularine-and-factor-viii-treatment-haemophilia_en.pdf"},
    {"id":"18244","name":"Presentation - Good practice: Medical Dictionary for Regulatory Activities coding of case reports resulting in harm (Sabine Brosch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-practice-medical-dictionary-regulatory-activities-coding-case-reports-resulting-harm-sabine-brosch_en.pdf"},
    {"id":"18245","name":"Presentation - Session 3 – ISO ICSR Implementation technical aspects - Part 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-12T12:30:00Z","last_updated_date":"2016-05-12T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-iso-icsr-implementation-technical-aspects-part-2_en.pdf"},
    {"id":"18248","name":"Participation of patients’/consumers’ representatives as observer\n\nto the PhVWP","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/MB/752664/2009","document_url":"https://www.ema.europa.eu/en/documents/other/participation-patientsconsumers-representatives-observer-phvwp_en.pdf"},
    {"id":"18249","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic bone marrow derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:45:00Z","last_updated_date":"2017-02-28T14:45:00Z","reference_number":"EMA/126870/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-bone-marrow-derived-mesenchymal-stem-cells_en.pdf-0"},
    {"id":"18252","name":"Reflection paper on non-clinical studies for generic nanoparticle iron medicinal product applications","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-04-07T02:00:00Z","last_updated_date":"2011-04-07T02:00:00Z","reference_number":"EMA/CHMP/SWP/100094/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-non-clinical-studies-generic-nanoparticle-iron-medicinal-product-applications_en.pdf"},
    {"id":"18253","name":"EU/3/07/489: Public summary of positive opinion for orphan designation of ciclosporin for the treatment of Herpes simplex virus stromal keratitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMEA/COMP/440430/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307489-public-summary-positive-opinion-orphan-designation-ciclosporin-treatment-herpes-simplex-virus-stromal-keratitis_en.pdf"},
    {"id":"18255","name":"Public statement on Vylaer Spiromax: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-01-26T01:00:00Z","last_updated_date":"2017-01-26T01:00:00Z","reference_number":"EMEA/H/C/003952","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-vylaer-spiromax-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"18257","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with considerations P.II on biological medicinal products finalised post-public consultation","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:00:00Z","last_updated_date":"2016-08-15T12:00:00Z","reference_number":"EMA/529641/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-considerations-pii-biological-medicinal-products-finalised-post-public-consultation_en.pdf"},
    {"id":"18258","name":"CVMP post-authorisation summary of positive opinion for Dexdomitor","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-06-15T02:00:00Z","last_updated_date":"2012-06-15T02:00:00Z","reference_number":"EMA/CVMP/345725/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-dexdomitor_en.pdf"},
    {"id":"18259","name":"Superseded - List of references supporting the HMPC assessment report on Aloe barbadensis Miller and Aloe (various species, mainly Aloe ferox Miller and its hybrids)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMEA/HMPC/76313/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-hmpc-assessment-report-aloe-barbadensis-miller-and-aloe-various-species-mainly-aloe-ferox-miller-and-its-hybrids_en.pdf"},
    {"id":"18260","name":"Committee for medicinal products for human use  summary of positive opinion  for Zopya","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-24T02:00:00Z","last_updated_date":"2009-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-zopya_en.pdf"},
    {"id":"18262","name":"Ionsys: measures to ensure that it is handled and used correctly","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2015-11-30T18:00:00Z","last_updated_date":"2015-11-30T18:00:00Z","reference_number":"EMA/734228/2015","document_url":"https://www.ema.europa.eu/en/documents/medication-error/ionsys-measures-ensure-it-handled-and-used-correctly_en.pdf"},
    {"id":"18263","name":"Presentation - The MidPharma and the European Network of Paediatric Research at the European Medicines Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:48Z","last_updated_date":"2011-05-27T15:25:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-midpharma-and-european-network-paediatric-research-european-medicines-agency_en.pdf"},
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    {"id":"18273","name":"Questions and answers on the shortage of Increlex","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/250270/2013 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-shortage-increlex_en.pdf"},
    {"id":"18274","name":"Overview of comments received on 'guideline on quality of biological active substances produced by transgene expression in animals'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T17:18:00Z","last_updated_date":"2013-06-10T17:18:00Z","reference_number":"EMA/CHMP/BWP/151908/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-quality-biological-active-substances-produced-transgene-expression-animals_en.pdf"},
    {"id":"18276","name":"European Medicines Agency: Clarification Questions 21st September 2006","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-21T02:00:00Z","last_updated_date":"2006-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-clarification-questions-21st-september-2006_en.pdf"},
    {"id":"18277","name":"Carazolol (Extension to cattle): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/592/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/carazolol-extension-cattle-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18281","name":"Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-10-17T17:40:44Z","reference_number":"EMA/447103/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetylsalicylic-acid-bisoprolol-list-nationally-authorised-medicinal-products-psusa00010287201511_en.pdf"},
    {"id":"18282","name":"Questions and Answers on the EMEA's action regarding the safety of Ketek (telithromycin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-01-27T01:00:00Z","last_updated_date":"2006-01-27T01:00:00Z","reference_number":"EMEA/31861/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-emeas-action-regarding-safety-ketek-telithromycin_en.pdf"},
    {"id":"18283","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 12 – 15 December 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T10:20:00Z","last_updated_date":"2016-12-16T10:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-12-15-december-2016_en.pdf"},
    {"id":"18284","name":"Draft guideline on production and quality control of monoclonal antibodies and related substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-04-05T02:00:00Z","last_updated_date":"2007-04-05T02:00:00Z","reference_number":"EMEA/CHMP/BWP/157653/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-production-and-quality-control-monoclonal-antibodies-and-related-substances_en.pdf"},
    {"id":"18286","name":"European Medicines Agency recommends new malaria\n\ntreatment for approval","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/496931/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-new-malaria-treatment-approval_en.pdf"},
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    {"id":"18290","name":"Alphacypermethrin: Summary Report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-09-01T02:00:00Z","last_updated_date":"2001-09-01T02:00:00Z","reference_number":"EMEA/MRL/800/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/alphacypermethrin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"18292","name":"Domperidone Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-06-17T17:00:00Z","last_updated_date":"2014-06-17T17:00:00Z","reference_number":"EMA/152501/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/domperidone-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"18294","name":"Withdrawal assessment report for Abilify","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-02-24T01:09:21Z","last_updated_date":"2010-02-24T01:09:21Z","reference_number":"EMA/CHMP/820673/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-abilify_en.pdf"},
    {"id":"18296","name":"Presentation - Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substances-quality-issues_en.pdf"},
    {"id":"18297","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations: General principles to address virus and vector shedding","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/449035/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-considerations-general-principles-address-virus-and-vector-shedding_en.pdf"},
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    {"id":"18303","name":"European Medicines Agency launches EudraGMP - The community GMP database","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-05-01T02:00:00Z","last_updated_date":"2007-05-01T02:00:00Z","reference_number":"EMEA/193640/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-eudragmp-community-gmp-database_en.pdf"},
    {"id":"18304","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Irish Paediatric Clinical Research Network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817620/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-irish-paediatric-clinical-research-network_en.pdf"},
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    {"id":"18308","name":"Agenda - Training session for patients and consumers involved in European Medicines Agency activities","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-12-05T17:31:00Z","last_updated_date":"2014-02-03T16:00:00Z","reference_number":"EMA/508479/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-patients-and-consumers-involved-european-medicines-agency-activities_en.pdf-0"},
    {"id":"18310","name":"Withdrawal assessment report for Prandin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2006-12-14T01:00:00Z","last_updated_date":"2006-12-14T01:00:00Z","reference_number":"EMEA/CHMP/511690/2006","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-prandin_en.pdf"},
    {"id":"18311","name":"CHMP ORGAM agenda for the meeting on 28 October 2016","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-11-04T15:25:00Z","last_updated_date":"2016-11-04T15:25:00Z","reference_number":"EMA/CHMP/679213/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-28-october-2016_en.pdf"},
    {"id":"18313","name":"Outline of a pilot project to rationalise international good-manufacturing-practice-inspection activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-11-06T01:00:00Z","last_updated_date":"2007-11-06T01:00:00Z","reference_number":"EMEA/INS/GMP/430438/2007","document_url":"https://www.ema.europa.eu/en/documents/other/outline-pilot-project-rationalise-international-good-manufacturing-practice-inspection-activities_en.pdf"},
    {"id":"18315","name":"CHMP summary of positive opinion for Vylaer Spiromax","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/CHMP/436529/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vylaer-spiromax_en.pdf"},
    {"id":"18317","name":"Annex 4 Required skills per profile - EMA-2012-09-IF","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"EMA/687438/2011","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-4-required-skills-profile-ema-2012-09-if_en.xls"},
    {"id":"18318","name":"Presentation - How do we sequence or combine immunotherapies with targeted therapies: European perspective (Paolo Ascierto) - S5.4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-do-we-sequence-or-combine-immunotherapies-targeted-therapies-european-perspective-paolo-ascierto-s54_en.pdf"},
    {"id":"18319","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Calcichew-D3 mite and associated names International Non-Proprietary Name (INN): Calcium 500mg / ch...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-12-02T00:08:21Z","last_updated_date":"2003-12-02T00:08:21Z","reference_number":"EMEA/CPMP/3258/03/en/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-calcichew-d3-mite-and-associated-names-international-non-proprietary-name-inn-calcium-500mg-ch_en.pdf"},
    {"id":"18321","name":"Protelos and Osseor Article-20 procedure - Annex I, II and III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/protelos-and-osseor-article-20-procedure-annex-i-ii-and-iii_en.pdf"},
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    {"id":"18326","name":"Presentation - Scanning the horizon - a regulatory perspective (David Mackay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scanning-horizon-regulatory-perspective-david-mackay_en.pdf"},
    {"id":"18327","name":"Presentation - Aims and objectives of the workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis) (Mair Powell)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-aims-and-objectives-workshop-development-antimycobacterial-medicinal-products-treat-mycobacterium-tuberculosis-mair-powell_en.pdf"},
    {"id":"18329","name":"EMA recommends treatment for rare cancer in children","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/330589/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-treatment-rare-cancer-children_en.pdf"},
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    {"id":"18381","name":"Qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T13:58:00Z","last_updated_date":"2018-04-19T13:58:00Z","reference_number":"EMA/CHMP/SAWP/226829/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-proactive-chronic-obstructive-pulmonary-disease-copd_en.pdf"},
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    {"id":"18392","name":"Methadone Article-107i procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-annex-i_en.pdf"},
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    {"id":"18396","name":"European Medicines Agency recommends the suspension of the marketing authorisation of Ionsys (fentanyl hydrochloride)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-21T00:09:21Z","last_updated_date":"2008-11-21T00:09:21Z","reference_number":"EMEA/CHMP/613852/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-marketing-authorisation-ionsys-fentanyl-hydrochloride_en.pdf"},
    {"id":"18397","name":"SGLT2 inhibitors Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-12T14:00:00Z","last_updated_date":"2015-06-12T14:00:00Z","reference_number":"EMEA/H/A-20/1419","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-article-20-procedure-notification_en.pdf"},
    {"id":"18398","name":"Opinion of the HMPC on a Community herbal monograph on Echinacea angustifolia DC., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-05-29T16:30:00Z","last_updated_date":"2012-05-29T16:30:00Z","reference_number":"EMA/HMPC/216954/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-echinacea-angustifolia-dc-radix_en.pdf"},
    {"id":"18401","name":"Wyeth Europa Limited withdraws its marketing authorisation application for Brilence","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/342273/201","document_url":"https://www.ema.europa.eu/en/documents/press-release/wyeth-europa-limited-withdraws-its-marketing-authorisation-application-brilence_en.pdf"},
    {"id":"18402","name":"Salicylic acid, sodium salicylate, aluminium salicylate, basic, and methyl salicylate: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/MRL/696/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/salicylic-acid-sodium-salicylate-aluminium-salicylate-basic-and-methyl-salicylate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18404","name":"Presentation - Scale down models for cell culture (Christian Hakemeyer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scale-down-models-cell-culture-christian-hakemeyer_en.pdf"},
    {"id":"18407","name":"EU/3/06/403: Public summary of positive opinion for orphan designation\n\nof 5-(2,6-Difluoro-phenoxy)-3(R,S)-{2(S)-[2(S)-(3-methoxycarbonyl-2(S)-{3-methyl-2(S)-[(quinoline-2-carbonyl)-amino]-butyrylamino}-propionylamino)-3...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-22T02:00:00Z","last_updated_date":"2015-05-08T03:00:00Z","reference_number":"EMEA/COMP/358708/2006 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306403-public-summary-positive-opinion-orphan-designation-5-26-difluoro-phenoxy-3rs-2s-2s-3-methoxycarbonyl-2s-3-methyl-2s-quinoline-2-carbonyl-amino-butyrylamino-propionylamino-3_en.pdf"},
    {"id":"18410","name":"Overview of comments received on 'Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture'","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-08-17T02:00:00Z","last_updated_date":"2011-08-17T02:00:00Z","reference_number":"EMA/CHMP/BWP/453628/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-quality-aspects-isolation-candidate-influenza-vaccine-viruses-cell-culture_en.pdf"},
    {"id":"18412","name":"Nicola Orlandi (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/nicola-orlandi-cv_en.pdf"},
    {"id":"18415","name":"Draft assessment report on Silybum marianum (L.) Gaertn., fructus","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2016-11-07T16:59:00Z","last_updated_date":"2016-11-07T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-silybum-marianum-l-gaertn-fructus_en.pdf-0"},
    {"id":"18418","name":"Guidance to applicants / marketing authorisation holders on oral explanations at CVMP","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T17:00:00Z","last_updated_date":"2017-02-24T17:00:00Z","reference_number":"EMA/CVMP/519444/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants-marketing-authorisation-holders-oral-explanations-cvmp_en.pdf"},
    {"id":"18421","name":"Report on the European network of paediatric research-European Medicines Agency workshop on gastrointestinal (GI) outcome measures to evaluate CFTR modulators for the treatment of cystic fibrosis (CF)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T17:10:00Z","last_updated_date":"2016-03-16T17:10:00Z","reference_number":"EMA/26775/2016","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-network-paediatric-research-european-medicines-agency-workshop-gastrointestinal-gi-outcome-measures-evaluate-cftr-modulators-treatment-cystic-fibrosis-cf_en.pdf"},
    {"id":"18422","name":"Presentation - Additional monitoring of medicines and direct patient reporting – impact on the package leaflet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-additional-monitoring-medicines-and-direct-patient-reporting-impact-package-leaflet_en.pdf"},
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    {"id":"18426","name":"List of references supporting the assessment of Ricinus communis L., oleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-07-22T02:00:00Z","last_updated_date":"2015-07-22T02:00:00Z","reference_number":"EMA/HMPC/572975/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-ricinus-communis-l-oleum_en.pdf"},
    {"id":"18432","name":"CHMP post-authorisation summary of positive opinion for Fycompa","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/324690/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-fycompa_en.pdf"},
    {"id":"18434","name":"Withdrawal letter: Prohippur","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T11:33:00Z","last_updated_date":"2018-04-27T11:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-prohippur_en.pdf"},
    {"id":"18435","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Start of review of Diane 35 and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T13:00:00Z","last_updated_date":"2013-02-08T13:00:00Z","reference_number":"EMA/76602/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-start-review-diane-35-and-other-medicines-containing-cyproterone-acetate-2-mg-and-ethinylestradiol-35-micrograms_en.pdf"},
    {"id":"18436","name":"CHMP post-authorisation summary of positive opinion for Travatan","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2014-11-21T13:00:00Z","reference_number":"EMA/CHMP/697464/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-travatan_en.pdf"},
    {"id":"18437","name":"Position paper on compliance of veterinary vaccines with veterinary vaccine monographs of the European pharmacopoeia","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-06-01T02:00:00Z","last_updated_date":"1999-06-01T02:00:00Z","reference_number":"EMEA/CVMP/140/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-compliance-veterinary-vaccines-veterinary-vaccine-monographs-european-pharmacopoeia_en.pdf"},
    {"id":"18438","name":"EU/3/16/1701: Public summary of opinion on orphan designation: Poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer for the treatment of...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/450723/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161701-public-summary-opinion-orphan-designation-polyoxy-12-ethanediyl-alpha-carboxymethyl-omega-methoxy-amide-arginase-1-cobalt-cofactor-synthetic-human-110-trimer-treatment_en.pdf"},
    {"id":"18440","name":"Minutes of the European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / substance, product, organisation and referential data (SPOR) task force meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-12-20T17:00:00Z","last_updated_date":"2017-12-20T17:00:00Z","reference_number":"EMA/839613/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf"},
    {"id":"18442","name":"European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-01T12:00:00Z","last_updated_date":"2013-10-01T12:00:00Z","reference_number":"EMA/589330/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-publishes-video-explaining-concept-medicines-under-additional-monitoring_en.pdf"},
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    {"id":"18444","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel ratiopharm","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/375222/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-ratiopharm_en.pdf"},
    {"id":"18448","name":"CHMP post-authorisation positive summary of opinion for Procoralan","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-12-16T01:00:00Z","last_updated_date":"2011-12-16T01:00:00Z","reference_number":"EMA/CHMP/963751/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-positive-summary-opinion-procoralan_en.pdf"},
    {"id":"18449","name":"ICH regulators forum - Peter Arlett","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ich-regulators-forum-peter-arlett_en.pdf"},
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    {"id":"18451","name":"Overview of comments received on 'Qualification opinion on paediatric ulcerative colitis activity index (PUCAI)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-01-20T17:10:00Z","last_updated_date":"2016-01-20T17:10:00Z","reference_number":"EMA/760013/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-qualification-opinion-paediatric-ulcerative-colitis-activity-index-pucai_en.pdf"},
    {"id":"18452","name":"Presentation - Multi-stakeholder late and early dialogue – The MoCa experience and potential contribution (Bucsics, MoCa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-stakeholder-late-and-early-dialogue-moca-experience-and-potential-contribution-bucsics-moca_en.pdf"},
    {"id":"18453","name":"Presentation - Accession preparation II- Preparing for dossiers evaluation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accession-preparation-ii-preparing-dossiers-evaluation_en.pdf"},
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    {"id":"18455","name":"Skye Pharma PLC withdraws its application to extend the marketing\n\nauthorisation for DepoCyte","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-06-30T02:00:00Z","last_updated_date":"2006-06-30T02:00:00Z","reference_number":"EMEA/245584/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/skye-pharma-plc-withdraws-its-application-extend-marketing-authorisation-depocyte_en.pdf"},
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    {"id":"18457","name":"Withdrawal letter: Plivensia","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-plivensia_en.pdf"},
    {"id":"18458","name":"Final  list of references supporting the assessment of Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/HMPC/712650/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-myroxylon-balsamum-l-harms-var-pereirae-royle-harms-balsamum_en.pdf"},
    {"id":"18462","name":"Note for guidance: Manufacture of the finished dosage form","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1995-12-01T01:00:00Z","last_updated_date":"1995-12-01T01:00:00Z","reference_number":"EMEA/CVMP/126/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-manufacture-finished-dosage-form_en.pdf"},
    {"id":"18463","name":"Presentation - Communication of difficulties with paediatric studies to PDCO","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T16:02:00Z","last_updated_date":"2018-06-18T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-difficulties-paediatric-studies-pdco_en.pdf"},
    {"id":"18464","name":"Scientific recommendation on classification of advanced therapy medicinal products: ex-vivo cultured and expanded human cord blood progenitor cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-10-21T20:00:00Z","last_updated_date":"2016-10-21T20:00:00Z","reference_number":"EMA/679217/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-ex-vivo-cultured-and-expanded-human-cord-blood-progenitor-cells_en.pdf"},
    {"id":"18467","name":"Committee for veterinary medicinal products: Meeting of 17 to 19 June 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-06-20T14:49:21Z","last_updated_date":"2003-06-20T14:49:21Z","reference_number":"EMEA/CVMP/595/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-17-19-june-2003_en.pdf"},
    {"id":"18469","name":"Presentation - European Patient Ambassador Programme (EPAP) (Kerstin Morrison)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-patient-ambassador-programme-epap-kerstin-morrison_en.pdf"},
    {"id":"18471","name":"Public statement on Sifrol, Daquiran, Mirapexin (pramipexole) - Sudden onset of sleep","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-07-19T02:00:00Z","last_updated_date":"1999-07-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-sifrol-daquiran-mirapexin-pramipexole-sudden-onset-sleep_en.pdf"},
    {"id":"18472","name":"Neomycin, including framycetin and soframycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/006/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/neomycin-including-framycetin-and-soframycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18473","name":"Kogenate Bayer and Helixate NexGen Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-10-29T12:50:00Z","reference_number":"EMA/PRAC/142799/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-timetable-procedure_en.pdf"},
    {"id":"18474","name":"High level business consultancy EMA/2013/23/FI - Technical specifications - Annex IX ordering process","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/high-level-business-consultancy-ema201323fi-technical-specifications-annex-ix-ordering-process_en.pdf"},
    {"id":"18475","name":"EU/3/15/1501: Public summary of opinion on orphan designation: Adeno-associated viral vector containing the human factor IX gene for treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2017-10-19T02:00:00Z","reference_number":"EMA/COMP/360279/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151501-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-factor-ix-gene-treatment-haemophilia-b_en.pdf"},
    {"id":"18477","name":"Reflection paper on the level of purification of extracts to be considered as herbal preparations","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/186645/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-level-purification-extracts-be-considered-herbal-preparations_en.pdf"},
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    {"id":"18481","name":"Proceedings for the nomination of the Executive Director","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-01T16:00:00Z","last_updated_date":"2015-10-01T16:00:00Z","reference_number":"EMA/MB/452503/2015","document_url":"https://www.ema.europa.eu/en/documents/other/proceedings-nomination-executive-director_en.pdf"},
    {"id":"18483","name":"VICH GL43: Target animal safety for veterinary pharmaceutical products - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-09-22T02:00:00Z","last_updated_date":"2008-09-22T02:00:00Z","reference_number":"EMEA/CVMP/VICH/393388/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl43-target-animal-safety-veterinary-pharmaceutical-products-step-7_en.pdf"},
    {"id":"18484","name":"Questions and answers on the withdrawal of the marketing application for Arxxant","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-03-22T01:00:00Z","last_updated_date":"2007-03-22T01:00:00Z","reference_number":"EMEA/117441/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-arxxant_sv.pdf"}},
    {"id":"18485","name":"Presentation - e-DoI and e-CV: Who/Why/How? (Marianna Kozikova)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-e-doi-and-e-cv-whowhyhow-marianna-kozikova_en.pdf"},
    {"id":"18487","name":"CHMP post-authorisation summary of positive opinion for Stelara","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/333057/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stelara_en.pdf-1"},
    {"id":"18489","name":"Communication from the Commission: Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation o...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-09-24T02:00:00Z","last_updated_date":"2008-09-24T02:00:00Z","reference_number":"n/a","document_url":"https://www.ema.europa.eu/en/documents/other/communication-commission-guideline-format-and-content-applications-agreement-or-modification-paediatric-investigation-plan-and-requests-waivers-or-deferrals-and-concerning-operation-o_en.pdf"},
    {"id":"18492","name":"European Medicines Agency recommends approval of medicine for reduction of alcohol consumption","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T13:00:00Z","last_updated_date":"2012-12-14T13:00:00Z","reference_number":"EMA/CHMP/786305/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-medicine-reduction-alcohol-consumption_en.pdf"},
    {"id":"18493","name":"Testosterone undecanoate (injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"18494","name":"Biologics Working Party (BWP) Ad-hoc Influenza Working Group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2017/2018","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T11:00:00Z","last_updated_date":"2017-04-12T12:00:00Z","reference_number":"EMA/CHMP/BWP/216216/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/biologics-working-party-bwp-ad-hoc-influenza-working-group-amended-european-union-recommendations-seasonal-influenza-vaccine-composition-season-20172018_en.pdf"},
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    {"id":"18501","name":"EU/3/02/118: Public summary of positive opinion for orphan designation of recombinant glycoprotein gp350 of Epstein-Barr virus for the prevention of post-transplantation lympho-proliferative disorders","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2002-12-17T00:00:00Z","last_updated_date":"2002-12-17T00:00:00Z","reference_number":"EMEA/COMP/2207/02","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302118-public-summary-positive-opinion-orphan-designation-recombinant-glycoprotein-gp350-epstein-barr-virus-prevention-post-transplantation-lympho-proliferative-disorders_en.pdf"},
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    {"id":"18516","name":"Submission of comments on 'Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)' (EMA/624809/2013)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-07-24T16:15:00Z","last_updated_date":"2014-07-24T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-draft-rules-procedures-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac-ema6248092013_en.doc"},
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    {"id":"18518","name":"Committee for veterinary medicinal products: Meeting of 11 to 13 March 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-03-14T12:39:21Z","last_updated_date":"2003-03-14T12:39:21Z","reference_number":"EMEA/CVMP/272/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-11-13-march-2003_en.pdf"},
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    {"id":"18532","name":"Electronic summary of product characteristics workshop: Participation request","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-27T19:10:42Z","last_updated_date":"2011-07-27T19:10:42Z","reference_number":"EMA/585618/2011","document_url":"https://www.ema.europa.eu/en/documents/other/electronic-summary-product-characteristics-workshop-participation-request_en.pdf"},
    {"id":"18535","name":"Thiocolchicoside Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/thiocolchicoside-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/thiocolchicoside-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/thiocolchicoside-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/thiocolchicoside-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/thiocolchicoside-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/thiocolchicoside-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/thiocolchicoside-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/thiocolchicoside-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/thiocolchicoside-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/thiocolchicoside-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/thiocolchicoside-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/thiocolchicoside-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/thiocolchicoside-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/thiocolchicoside-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/thiocolchicoside-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/thiocolchicoside-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/thiocolchicoside-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/thiocolchicoside-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/thiocolchicoside-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/thiocolchicoside-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/thiocolchicoside-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/thiocolchicoside-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/thiocolchicoside-article-31-referral-annex-iii_sv.pdf"}},
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    {"id":"18539","name":"Final list of references supporting the assessment of Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/HMPC/627059/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"18541","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 13-14 May 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T13:00:00Z","last_updated_date":"2013-06-07T13:00:00Z","reference_number":"EMA/HMPC/301544/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-13-14-may-2013_en.pdf"},
    {"id":"18542","name":"EU/3/04/242: Public summary of positive opinion for orphan designation of N-(methyl-diazacyclohexyl-methylbenzamide)-azaphenyl-aminothiopyrrole for the treatment of mastocytosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-26T02:00:00Z","last_updated_date":"2005-10-26T02:00:00Z","reference_number":"EMEA/COMP/100459/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304242-public-summary-positive-opinion-orphan-designation-n-methyl-diazacyclohexyl-methylbenzamide-azaphenyl-aminothiopyrrole-treatment-mastocytosis_en.pdf"},
    {"id":"18543","name":"Tredaptive, Pelzont and Trevaclyn Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-21T01:00:00Z","last_updated_date":"2012-12-21T01:00:00Z","reference_number":"EMA/819878/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/tredaptive-pelzont-and-trevaclyn-article-20-procedure-review-started_en.pdf"},
    {"id":"18545","name":"CVMP summary of positive opinion for Porcilis PCV ID","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-10T17:00:00Z","last_updated_date":"2015-07-10T17:00:00Z","reference_number":"EMA/CVMP/354782/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-porcilis-pcv-id_en.pdf"},
    {"id":"18546","name":"Draft list of references supporting the assessment of Malva sylvestris L. and/or Malva neglecta Wallr., folium and Malva sylvestris L., flos - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"EMA/HMPC/749540/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-malva-sylvestris-l-andor-malva-neglecta-wallr-folium-and-malva-sylvestris-l-flos-first-version_en.pdf-0"},
    {"id":"18547","name":"TGN1412: What happened? - Suntharalingam & N Panoskaltsis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/tgn1412-what-happened-suntharalingam-n-panoskaltsis_en.pdf"},
    {"id":"18551","name":"Presentation - Orphan medicinal products: Challenges faced by companies in implementing the existing guidelines (Robert Morgan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orphan-medicinal-products-challenges-faced-companies-implementing-existing-guidelines-robert-morgan_en.pdf"},
    {"id":"18552","name":"Work instructions for non-removal of the European public assessment report following suspension of the marketing authorisation","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2008-07-01T02:00:00Z","last_updated_date":"2012-09-13T17:21:00Z","reference_number":"WIN/H/3216","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-non-removal-european-public-assessment-report-following-suspension-marketing-authorisation_en.pdf"},
    {"id":"18558","name":"CHMP post-authorisation summary of positive opinion for Vimpat (II-65-G)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T14:00:00Z","last_updated_date":"2017-07-21T14:00:00Z","reference_number":"EMA/CHMP/433563/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vimpat-ii-65-g_en.pdf"},
    {"id":"18559","name":"Core SPC for human Tick-borne Encephalitis immunoglobulin for intramuscular use (CPMP/BPWG/3732/02)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"CPMP/BPWG/3732/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/core-spc-human-tick-borne-encephalitis-immunoglobulin-intramuscular-use-cpmpbpwg373202_en.pdf"},
    {"id":"18560","name":"Agenda and registration form - EudraVigilance training on the electronic reporting of Individual Case Safety Reports (ICSRs) in the European Economic Area","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T15:00:00Z","last_updated_date":"2014-06-13T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-icsrs-european-economic-area_en.pdf"},
    {"id":"18561","name":"Priorix - Article 30 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-06-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/priorix-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/priorix-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/priorix-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/priorix-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/priorix-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/priorix-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/priorix-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/priorix-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/priorix-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/priorix-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/priorix-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/priorix-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/priorix-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/priorix-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/priorix-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/priorix-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/priorix-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/priorix-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/priorix-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/priorix-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/priorix-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/priorix-article-30-referral-annex-iii_sv.pdf"}},
    {"id":"18563","name":"Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-04T02:00:00Z","last_updated_date":"2016-10-04T02:00:00Z","reference_number":"EMA/637689/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/trimetazidine-list-nationally-authorised-medicinal-products-emeahnpsrj0002_en.pdf"},
    {"id":"18564","name":"New measures to avoid valproate exposure in pregnancy endorsed","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/145600/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-measures-avoid-valproate-exposure-pregnancy-endorsed_en.pdf"},
    {"id":"18566","name":"Tibocina-Article 29(4) referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-08T02:00:00Z","last_updated_date":"2014-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tibocina-article-294-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tibocina-article-294-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tibocina-article-294-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tibocina-article-294-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tibocina-article-294-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tibocina-article-294-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tibocina-article-294-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tibocina-article-294-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tibocina-article-294-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/tibocina-article-294-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tibocina-article-294-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tibocina-article-294-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tibocina-article-294-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tibocina-article-294-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tibocina-article-294-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tibocina-article-294-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tibocina-article-294-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tibocina-article-294-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tibocina-article-294-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tibocina-article-294-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tibocina-article-294-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tibocina-article-294-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tibocina-article-294-referral-annex-iii_sv.pdf"}},
    {"id":"18567","name":"VICH GL18(R): Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-09-26T13:49:00Z","last_updated_date":"2011-09-26T13:49:00Z","reference_number":"EMA/CVMP/VICH/502/99-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl18r-impurities-residual-solvents-new-veterinary-medicinal-products-active-substances-and-excipients-revision-1_en.pdf"},
    {"id":"18569","name":"Presentation - Europharm SMC feedback (Telma Costa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-europharm-smc-feedback-telma-costa_en.pdf"},
    {"id":"18571","name":"Reflection paper on assessment of bioavailability of bound residues in food commodities of animal origin in the context of council regulation (EEC) NO 2377/90","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-09-22T02:00:00Z","last_updated_date":"2008-09-22T02:00:00Z","reference_number":"EMEA/CVMP/SWP/95682/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-assessment-bioavailability-bound-residues-food-commodities-animal-origin-context-council-regulation-eec-no-237790_en.pdf"},
    {"id":"18572","name":"European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/716841/20","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-changes-use-leukaemia-medicine-iclusig-ponatinib-order-minimise-risk-blood-clots_en.pdf"},
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    {"id":"18576","name":"Agenda - Harmonising the approach to VeDDRA coding workshop - 27 November 2013","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2013-11-27T01:00:00Z","last_updated_date":"2014-02-11T01:00:00Z","reference_number":"EMA/500544/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-harmonising-approach-veddra-coding-workshop-27-november-2013_en.pdf"},
    {"id":"18578","name":"Superseded list of references supporting the assessment report on: Verbasci flos Verbascum thapsus L., V. densiflorum Bertol. and V. phlomoides L., flos (mullein flower)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/HMPC/395238/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-verbasci-flos-verbascum-thapsus-l-v-densiflorum-bertol-and-v-phlomoides-l-flos-mullein-flower_en.pdf"},
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    {"id":"18592","name":"Joint meeting with all interested parties on a continuity policy for orphan medicinal products in the European Union","type":"report","status":"unknown","consultation_date":"","first_published_date":"2002-12-06T01:00:00Z","last_updated_date":"2002-12-06T01:00:00Z","reference_number":"EMEA/31723/02","document_url":"https://www.ema.europa.eu/en/documents/report/joint-meeting-all-interested-parties-continuity-policy-orphan-medicinal-products-european-union_en.pdf"},
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    {"id":"18596","name":"Novartis withdraws its application to extend the marketing authorisation for Zometa","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-20T00:09:21Z","last_updated_date":"2007-11-20T00:09:21Z","reference_number":"EMEA/541192/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/novartis-withdraws-its-application-extend-marketing-authorisation-zometa_en.pdf"},
    {"id":"18601","name":"Presentation - Strengthening collaborations for operating pharmacovigilance in Europe Joint Action (L. Loughlin, MHRA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-collaborations-operating-pharmacovigilance-europe-joint-action-l-loughlin-mhra_en.pdf"},
    {"id":"18605","name":"EudraVigilance system components","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-system-components_en.pdf"},
    {"id":"18609","name":"Withdrawal assessment report for Contusugene ladenovec gendux","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T01:00:00Z","last_updated_date":"2009-12-07T01:00:00Z","reference_number":"EMEA/CHMP/453445/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-contusugene-ladenovec-gendux_en.pdf"},
    {"id":"18611","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-07-01T19:00:00Z","last_updated_date":"2016-07-01T19:00:00Z","reference_number":"EMA/CAT/358066/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-june-2016_en.pdf"},
    {"id":"18612","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 26-29 June 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-07-18T18:20:00Z","last_updated_date":"2018-07-18T18:20:00Z","reference_number":"EMA/PDCO/462978/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-26-29-june-2018_en.pdf"},
    {"id":"18613","name":"CMDh confirms recommendations on restricting use of domperidone-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T17:00:00Z","last_updated_date":"2014-04-25T17:00:00Z","reference_number":"EMA/236452/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/cmdh-confirms-recommendations-restricting-use-domperidone-containing-medicines_en.pdf"},
    {"id":"18614","name":"Points to consider on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (ACS) without persistent st-segment elevation - Superseded document","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-02-17T01:00:00Z","last_updated_date":"2000-02-17T01:00:00Z","reference_number":"CPMP/EWP/570/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-clinical-investigation-new-medicinal-products-treatment-acute-coronary-syndrome-acs-without-persistent-st-segment-elevation-superseded-document_en.pdf"},
    {"id":"18615","name":"Overview of comments received on ' Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) ' (EMA/CHMP...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-20T17:00:00Z","last_updated_date":"2012-03-20T17:00:00Z","reference_number":"EMA/CHMP/QWP/686808/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-pharmaceutical-development-intravenous-medicinal-products-containing-active-substances-solubilised-micellar-systems-non-polymeric-surfactants-emachmp_en.pdf"},
    {"id":"18616","name":"EU/3/10/745: Public summary of positive opinion for Dexamethasone (40 mg tablet) for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/168763/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310745-public-summary-positive-opinion-dexamethasone-40-mg-tablet-treatment-multiple-myeloma_en.pdf"},
    {"id":"18618","name":"Renin-angiotensin-system (RAS)-acting agents Article-31 referral - PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-05-17T02:00:00Z","last_updated_date":"2013-05-17T02:00:00Z","reference_number":"EMA/PRAC/290692/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"18619","name":"Questions and answers on the recommendation for the refusal of the marketing authorization for Genasense","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorization-genasense_sv.pdf"}},
    {"id":"18620","name":"Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-07-21T02:00:00Z","last_updated_date":"2011-07-21T02:00:00Z","reference_number":"EMA/587515/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/sun-pharmaceutical-industries-europe-bv-withdraws-its-marketing-authorisation-application-doxorubicin-sun_en.pdf"},
    {"id":"18621","name":"Draft agenda - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) and Substance, Product, Organisation and Referential data (SPOR) task force meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-02-28T01:00:00Z","last_updated_date":"2017-02-28T01:00:00Z","reference_number":"EMA/86223/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-and-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf"},
    {"id":"18623","name":"Presentation - Update on the new clinical trial regulation (Fabio D'Atri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-new-clinical-trial-regulation-fabio-datri_en.pdf"},
    {"id":"18625","name":"Technical specification - Annex 02 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-02-15T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-02-external-service-providers-software-applications-ema201213ict_en.xls"},
    {"id":"18626","name":"CHMP post-authorisation summary of positive opinion for Izba","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T14:00:00Z","last_updated_date":"2017-05-19T14:00:00Z","reference_number":"EMA/CHMP/269250/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-izba_en.pdf"},
    {"id":"18627","name":"Calcium pantothenate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-06-01T02:00:00Z","last_updated_date":"2001-06-01T02:00:00Z","reference_number":"EMEA/MRL/790/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/calcium-pantothenate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18629","name":"Final list of references supporting the assessment of Sambucus nigra L., fructus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-04-29T02:00:00Z","last_updated_date":"2014-04-29T02:00:00Z","reference_number":"EMA/HMPC/44212/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"18630","name":"Questions and answers on the review of systemic medicines containing nimesulide","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2012-04-19T02:00:00Z","reference_number":"EMA/382884/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-systemic-medicines-containing-nimesulide_sv.pdf"}},
    {"id":"18631","name":"Referentials Management Services (RMS) operating model","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-01T11:05:00Z","last_updated_date":"2018-05-28T13:30:00Z","reference_number":"EMA/412376/2016","document_url":"https://www.ema.europa.eu/en/documents/other/referentials-management-services-rms-operating-model_en.pdf"},
    {"id":"18632","name":"EU/3/04/259: Public summary of positive opinion for orphan designation of acetylcysteine for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/199698/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304259-public-summary-positive-opinion-orphan-designation-acetylcysteine-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
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    {"id":"18637","name":"Public statement on Tasermity: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-03-27T13:40:00Z","last_updated_date":"2018-03-27T13:40:00Z","reference_number":"EMA/118962/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-tasermity-cessation-validity-marketing-authorisation-european-union_en.pdf"},
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    {"id":"18642","name":"Presentation - EMA/EGA workshop - Session 2: Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms - Injectable modified release products (Sotiris Michaleas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-2-guideline-pharmacokinetic-and-clinical-evaluation-modified-release-dosage-forms-injectable-modified-release-products-sotiris-michaleas_en.pdf"},
    {"id":"18643","name":"Minutes of the 2017 annual members meeting of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T12:45:00Z","last_updated_date":"2017-07-24T12:45:00Z","reference_number":"EMA/329833/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-2017-annual-members-meeting-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
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    {"id":"18647","name":"Presentation - Preparing for the simplified reporting of suspected adverse reactions in the European Union: training module PhV-M3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2016-10-10T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preparing-simplified-reporting-suspected-adverse-reactions-european-union-training-module-phv-m3_en.pdf"},
    {"id":"18648","name":"European Medicines Agency recommends approval of Gazyvaro for chronic lymphocytic leukaemia","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/307827/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-gazyvaro-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"18650","name":"Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"EMEA/CHMP/BMWP/14327/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-first-version_en.pdf"},
    {"id":"18651","name":"CHMP summary of positive opinion for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2010-09-24T02:00:00Z","reference_number":"EMA/CHMP/597536/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-prepandemic-influenza-vaccine-h5n1-surface-antigen-inactivated-adjuvanted-novartis-vaccines-and-diagnostics_en.pdf"},
    {"id":"18652","name":"Zydelig Article-20 procedure - CHMP confirms recommendations for use of Zydelig","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-chmp-confirms-recommendations-use-zydelig_en.pdf"},
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    {"id":"18656","name":"EU/3/17/1834: Public summary of opinion on orphan designation: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/83325/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171834-public-summary-opinion-orphan-designation-cyclol-alanyl-l-seryl-l-isoleucyl-l-prolyl-l-prolyl-l-glutaminyl-l-lysyl-l-tyrosyl-d-prolyl-l-prolyl-2s-2-aminodecanoyl-l-alpha-glutamyl-l_en.pdf"},
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    {"id":"18660","name":"Day 150 or Day 195 joint response assessment report - Clinical template - Rev. 05. 21","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2006-09-01T02:09:00Z","last_updated_date":"2021-06-25T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-150-or-day-195-joint-response-assessment-report-clinical-template-rev-05-21_en.docx"},
    {"id":"18663","name":"Committee for medicinal products for human use summary of positive opinion for Duloxetine Boehringer Ingelheim","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/333730/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-duloxetine-boehringer-ingelheim_en.pdf"},
    {"id":"18664","name":"Working party on Herbal Medicinal Products: Final proposals for comments on the Committee for Proprietary Medicinal Products (CPMP) note for guidance on stability testing after a Type II Variation to a marketing authoris...","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/HMPWP/21/99","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-final-proposals-comments-committee-proprietary-medicinal-products-cpmp-note-guidance-stability-testing-after-type-ii-variation-marketing-authoris_en.pdf"},
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    {"id":"18666","name":"CHMP summary of positive opinion for Genvoya","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T14:00:00Z","last_updated_date":"2015-09-25T14:00:00Z","reference_number":"EMA/628515/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-genvoya_en.pdf"},
    {"id":"18667","name":"Article-31 referral - European Medicines Agency recommends restricting use of cilostazol-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"EMA/423411/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_sv.pdf"}},
    {"id":"18668","name":"Overview of comments received on 'Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market' (EMA/CVMP/IWP/123243/2006-Rev.3) - Revision ...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T12:30:00Z","last_updated_date":"2017-04-21T12:30:00Z","reference_number":"EMA/CVMP/IWP/506137/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-guideline-data-requirements-immunological-veterinary-medicinal-products-intended-minor-use-or-minor-species-mumslimited-market-emacvmpiwp1232432006-rev3-revision_en.pdf"},
    {"id":"18670","name":"Meeting of the EMEA working party on herbal medicinal products 29 - 30 October 2001","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-11-08T01:00:00Z","last_updated_date":"2001-11-08T01:00:00Z","reference_number":"EMEA/HMPWP/83/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-29-30-october-2001_en.pdf"},
    {"id":"18671","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2015","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2016-12-08T10:10:00Z","last_updated_date":"2016-12-08T10:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2015_en.pdf"},
    {"id":"18672","name":"Cryopterone / ethinylestradiol-containing medicines: Article-107i procedure - Rationale for the triggering of procedure under Article 107i of Directive 2001/83/EC on cyproterone / ethinylestradiol (2 mg / 0.035 mg) prese...","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-02-27T17:00:00Z","last_updated_date":"2013-03-18T12:00:00Z","reference_number":"EMEA/H/A-107i/1357","document_url":"https://www.ema.europa.eu/en/documents/referral/cryopterone-ethinylestradiol-containing-medicines-article-107i-procedure-rationale-triggering-procedure-under-article-107i-directive-200183ec-cyproterone-ethinylestradiol-2-mg-0035-mg-prese_en.pdf"},
    {"id":"18674","name":"Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-11-12T01:00:00Z","last_updated_date":"2010-11-12T01:00:00Z","reference_number":"EMA/HMPC/3626/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-stability-testing-herbal-medicinal-products-and-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"18676","name":"EU/3/16/1764: Public summary of positive opinion for orphan designation of tetrofosmin for the diagnosis of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/COMP/611816/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161764-public-summary-positive-opinion-orphan-designation-tetrofosmin-diagnosis-glioma_en.pdf"},
    {"id":"18677","name":"CHMP post-authorisation summary of positive opinion for Ilaris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/CHMP/433406/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ilaris_en.pdf-0"},
    {"id":"18678","name":"Flupirtine-containing medicines Article-107i procedure - Notification","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-08T13:00:00Z","last_updated_date":"2013-03-08T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-notification_en.pdf"},
    {"id":"18679","name":"Declation of interests: Minna Leppà¤nen","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-01T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declation-interests-minna-leppanen_en.pdf"},
    {"id":"18681","name":"Current regulatory thinking For viral shedding studies in The European Union - Sharon Longhurst","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/current-regulatory-thinking-viral-shedding-studies-european-union-sharon-longhurst_en.pdf"},
    {"id":"18682","name":"Presentation - EMA/EGA workshop - Session 1: Orally administered Modified Release Products - European Regulatory Requirements (Henrike Potthast)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-1-orally-administered-modified-release-products-european-regulatory-requirements-henrike-potthast_en.pdf"},
    {"id":"18685","name":"EMA recommends new safety measures for Zydelig","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"EMA/201814/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-new-safety-measures-zydelig_en.pdf"},
    {"id":"18688","name":"Agenda – European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"EMA/455573/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-european-federation-pharmaceutical-industries-and-associations-modelling-and-simulation-workshop_en.pdf"},
    {"id":"18689","name":"EU/3/14/1309: Public summary of opinion on orphan designation: 17α,21-dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMA/COMP/431749/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141309-public-summary-opinion-orphan-designation-17i-21-dihydroxy-16i-methyl-pregna-14911-triene-320-dione-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"18690","name":"Girolan Article-34 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-15T02:00:00Z","last_updated_date":"2018-06-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/girolan-article-34-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/girolan-article-34-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/girolan-article-34-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/girolan-article-34-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/girolan-article-34-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/girolan-article-34-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/girolan-article-34-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/girolan-article-34-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/girolan-article-34-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/girolan-article-34-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/girolan-article-34-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/girolan-article-34-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/girolan-article-34-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/girolan-article-34-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/girolan-article-34-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/girolan-article-34-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/girolan-article-34-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/girolan-article-34-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/girolan-article-34-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/girolan-article-34-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/girolan-article-34-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/girolan-article-34-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/girolan-article-34-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"18691","name":"Presentation - Immunologicals/ New developments","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunologicals-new-developments_en.pdf"},
    {"id":"18693","name":"EU/3/16/1772: Public summary of positive opinion for orphan designation of adeno-associated viral vector serotype 8 containing the human UGT1A1 genefor the treatment of Crigler-Najjar syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2021-02-03T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161772-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-ugt1a1-genefor-treatment-crigler-najjar-syndrome_en.pdf"},
    {"id":"18695","name":"Improving medicines for older people","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2013-05-22T12:00:00Z","last_updated_date":"2013-05-22T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/improving-medicines-older-people_en.pdf"},
    {"id":"18698","name":"Guiding principles: Processing joint Food and Drug Administration / European Medicines Agency voluntary genomic data submissions (VGDSs) within the framework of the confidentiality arrangement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-05-31T02:09:21Z","last_updated_date":"2006-05-31T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/guiding-principles-processing-joint-food-and-drug-administration-european-medicines-agency-voluntary-genomic-data-submissions-vgdss-within-framework-confidentiality-arrangement_en.pdf"},
    {"id":"18700","name":"Amisulpride: List of nationally authorised medicinal products -PSUSA/00000167/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2016-10-17T19:40:20Z","reference_number":"EMA/701558/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/amisulpride-list-nationally-authorised-medicinal-products-psusa00000167201501_en.pdf"},
    {"id":"18701","name":"Publication of clinical reports","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-02T19:00:00Z","last_updated_date":"2014-10-02T19:00:00Z","reference_number":"EMA/601455/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/publication-clinical-reports_en.pdf"},
    {"id":"18702","name":"Work plan for Good Clinical Practice (GCP) Inspectors Working Group for 2017","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-02-21T18:00:00Z","last_updated_date":"2017-02-21T18:00:00Z","reference_number":"EMA/INS/GCP/13279/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-good-clinical-practice-gcp-inspectors-working-group-2017_en.pdf"},
    {"id":"18705","name":"EU/3/11/856: Public summary of positive opinion for orphan designation:  Recombinant thymidine phosphorylase encapsulated in autologous erythrocytes for the treatment of mitochondrial neurogastrointestinal encephalomyopa...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMA/COMP/89527/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311856-public-summary-positive-opinion-orphan-designation-recombinant-thymidine-phosphorylase-encapsulated-autologous-erythrocytes-treatment-mitochondrial-neurogastrointestinal-encephalomyopa_en.pdf"},
    {"id":"18706","name":"EU/3/16/1791: Public summary of positive opinion for orphan designation of vaccine consisting of 5 survivin peptides with different human leukocyte antigen restrictions, for the treatment of ovarian cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T10:54:00Z","last_updated_date":"2016-12-14T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161791-public-summary-positive-opinion-orphan-designation-vaccine-consisting-5-survivin-peptides-different-human-leukocyte-antigen-restrictions-treatment-ovarian-cancer_en.pdf"},
    {"id":"18707","name":"Presentation - An industry perspective on big data: from genomics to big data to real world data (Bart Vannieuwenhuyse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-big-data-genomics-big-data-real-world-data-bart-vannieuwenhuyse_en.pdf"},
    {"id":"18711","name":"EU/3/12/1091: Public summary of opinion on orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene for treatment of beta thalassaemia int...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2022-11-30T01:00:00Z","reference_number":"EMA/COMP/2193/2013 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121091-public-summary-opinion-orphan-designation-autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-encoding-human-betaa-t87q-globin-gene-treatment-beta-thalassaemia-int_en.pdf"},
    {"id":"18716","name":"Declaration of interests - Peter Helms","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-peter-helms_en.pdf"},
    {"id":"18718","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the June 2009  meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-06-09T02:09:21Z","last_updated_date":"2009-06-09T02:09:21Z","reference_number":"EMEA/COMP/344079/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-june-2009-meeting_en.pdf"},
    {"id":"18719","name":"EU/3/17/1861: Public summary of opinion on orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester for the tre...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/211274/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171861-public-summary-opinion-orphan-designation-s-8-2-amino-6-1-5-chloro-biphenyl-2-yl-r-222-trifluoro-ethoxy-pyrimidin-4-yl-28-diaza-spiro45decane-3-carboxylic-acid-ethyl-ester-tre_en.pdf"},
    {"id":"18723","name":"EU/3/04/223: Public summary of positive opinion for orphan designation of heparin sodium for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T14:06:00Z","last_updated_date":"2017-02-10T13:06:00Z","reference_number":"EMEA/COMP/169351/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304223-public-summary-positive-opinion-orphan-designation-heparin-sodium-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"18725","name":"Presentation - The ethical considerations of placebo study design in neuromyelitis optica (M. Rosa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ethical-considerations-placebo-study-design-neuromyelitis-optica-m-rosa_en.pdf"},
    {"id":"18726","name":"Welcome to participants and objectives of the meeting - Alfred Hera","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:09:21Z","last_updated_date":"2009-05-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/welcome-participants-and-objectives-meeting-alfred-hera_en.pdf"},
    {"id":"18727","name":"Opinion following an Article 34 referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated 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    {"id":"18728","name":"Nomegestrol: List of nationally authorised medicinal products - PSUSA/00002181/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-21T01:00:00Z","last_updated_date":"2016-10-18T12:37:33Z","reference_number":"EMA/49392/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/nomegestrol-list-nationally-authorised-medicinal-products-psusa00002181201501_en.pdf"},
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    {"id":"18732","name":"Presentation - Dose–exposure–response relationships: the basis of effective dose-regimen selection - Break-out session 2 theme 1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-exposure-response-relationships-basis-effective-dose-regimen-selection-break-out-session-2-theme-1_en.pdf"},
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    {"id":"18741","name":"Presentation - PK data for supporting PK-PD analyses (David Tenero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pk-data-supporting-pk-pd-analyses-david-tenero_en.pdf"},
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    {"id":"18751","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substance classes","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:01Z","last_updated_date":"2014-01-17T18:15:00Z","reference_number":"EMA/136147/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-substance-classes_en.xls"},
    {"id":"18752","name":"Overview of comments received on European Union herbal monograph on Symphytum officinale L., radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2015-06-05T02:00:00Z","last_updated_date":"2015-06-05T02:00:00Z","reference_number":"EMA/HMPC/44385/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-symphytum-officinale-l-radix_en.pdf"},
    {"id":"18753","name":"Final list of references supporting the assessment report on: Passiflorae herba Passiflora incarnata L., herba (passion flower)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-06-18T12:05:00Z","last_updated_date":"2014-06-18T12:05:00Z","reference_number":"EMA/HMPC/669739/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-report-passiflorae-herba-passiflora-incarnata-l-herba-passion-flower_en.pdf"},
    {"id":"18754","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 28 – 31 May 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/CHMP/SAWP/366547/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-28-31-may-2018_en.pdf"},
    {"id":"18755","name":"EU/3/08/575: Public summary of positive opinion for orphan designation ofcarglumic acid for the treatment of isovaleric acidaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2021-06-09T15:00:00Z","reference_number":"EMEA/COMP/481646/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308575-public-summary-positive-opinion-orphan-designation-ofcarglumic-acid-treatment-isovaleric-acidaemia_en.pdf"},
    {"id":"18756","name":"Final assessment report on Primula veris L. and / or Primula elatior (L.) Hill, flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T01:00:00Z","last_updated_date":"2013-03-04T01:00:00Z","reference_number":"EMA/HMPC/136583/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-primula-veris-l-and-or-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"18759","name":"Technical specifications - Annex VIIA substances and related substance groups: Procurement procedure EMA/2014/48/PH","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2014-11-04T10:00:00Z","last_updated_date":"2014-11-04T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-viia-substances-and-related-substance-groups-procurement-procedure-ema201448ph_en.pdf"},
    {"id":"18761","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the April 2009 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-04-08T02:09:21Z","last_updated_date":"2009-04-08T02:09:21Z","reference_number":"EMEA/COMP/159165/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-april-2009-meeting_en.pdf"},
    {"id":"18762","name":"Ancillary - Day 80 Non-clinical and clinical template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:30:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-80-non-clinical-and-clinical-template-rev1016_en.doc"},
    {"id":"18764","name":"EU/3/16/1755: Public summary of positive opinion for orphan designation of melatonin for the treatment of Smith-Magenis syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/619571/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161755-public-summary-positive-opinion-orphan-designation-melatonin-treatment-smith-magenis-syndrome_en.pdf"},
    {"id":"18767","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n17-19 March 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T00:09:21Z","last_updated_date":"2008-03-20T00:09:21Z","reference_number":"EMEA/CHMP/140780/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-17-19-march-2008_en.pdf"},
    {"id":"18769","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 30 March-1 April 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T17:10:00Z","last_updated_date":"2016-04-08T17:10:00Z","reference_number":"EMA/PDCO/253224/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-30-march-1-april-2016_en.pdf"},
    {"id":"18772","name":"Bacillus clausii multi-antibioresistant spores: List of nationally authorised medicinal products - PSUSA/00000284/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T18:40:00Z","last_updated_date":"2017-10-26T18:48:20Z","reference_number":"EMA/715760/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/bacillus-clausii-multi-antibioresistant-spores-list-nationally-authorised-medicinal-products-psusa00000284201611_en.pdf"},
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    {"id":"18776","name":"Ergot derivatives Article-31 referral - Dihydroergocristine - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-i_sv.pdf"}},
    {"id":"18778","name":"Gentamicin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"EMEA/MRL/729/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gentamicin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18779","name":"F(ab’)2 fragments of equine antirabies immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001348/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-16T15:20:00Z","last_updated_date":"2017-01-16T15:23:01Z","reference_number":"EMA/28510/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/fab2-fragments-equine-antirabies-immunoglobulin-list-nationally-authorised-medicinal-products-psusa00001348201605_en.pdf"},
    {"id":"18783","name":"European Medicines Agency review of pandemic vaccines underway","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-07-24T02:00:00Z","last_updated_date":"2009-07-24T02:00:00Z","reference_number":"EMEA/468568/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-review-pandemic-vaccines-underway_en.pdf"},
    {"id":"18785","name":"Presentation - Involvement of patients: Outcome of pilot project (N. Bere, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involvement-patients-outcome-pilot-project-n-bere-ema_en.pdf"},
    {"id":"18786","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 18-21 January 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-28T00:09:21Z","last_updated_date":"2010-01-28T00:09:21Z","reference_number":"EMA/CHMP/32068/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-january-2010_en.pdf"},
    {"id":"18787","name":"Presentation - Non-clinical approaches for immunogenicity assessment: predictive models (Mark Fogg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-clinical-approaches-immunogenicity-assessment-predictive-models-mark-fogg_en.pdf"},
    {"id":"18789","name":"Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T02:00:00Z","last_updated_date":"2012-04-20T02:00:00Z","reference_number":"EMA/265750/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-yvidually-and-associated-names-ethinylestradiol-drospirenone-002-mg3-mg-tablets_sv.pdf"}},
    {"id":"18794","name":"PRAC review does not confirm increase in heart problems with testosterone medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2014-10-10T02:00:00Z","reference_number":"EMA/611318/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-review-does-not-confirm-increase-heart-problems-testosterone-medicines_en.pdf"},
    {"id":"18795","name":"Objectives of the Working Group - Noel Wathion","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2003-05-08T02:00:00Z","last_updated_date":"2003-05-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/objectives-working-group-noel-wathion_en.pdf"},
    {"id":"18796","name":"European Medicines Agency confirms recommendation to suspend Tredaptive, Pelzont and Trevaclyn","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-01-18T16:03:00Z","reference_number":"EMA/CHMP/21862/2013 Rev","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-confirms-recommendation-suspend-tredaptive-pelzont-and-trevaclyn_en.pdf"},
    {"id":"18797","name":"Aminosalicylate sodium : List of nationally authorised medicinal products - PSUSA/00000165/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-14T14:05:00Z","last_updated_date":"2017-06-14T14:07:12Z","reference_number":"EMA/375673/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/aminosalicylate-sodium-list-nationally-authorised-medicinal-products-psusa00000165201610_en.pdf"},
    {"id":"18799","name":"Superseded opinion of the HMPC on a community herbal monograph on Vitis vinifera L. folium - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/458286/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-vitis-vinifera-l-folium-first-version_en.pdf"},
    {"id":"18804","name":"Implementation strategy of ICH Q3D guideline","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-08T16:45:00Z","last_updated_date":"2017-03-08T16:45:00Z","reference_number":"EMA/CHMP/QWP/115498/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/implementation-strategy-ich-q3d-guideline_en.pdf"},
    {"id":"18805","name":"Public Statement on Abacavir (Ziagen) - Important  safety information on hypersensitivity reactions and respiratory symptoms","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-01-24T01:00:00Z","last_updated_date":"2000-01-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-abacavir-ziagen-important-safety-information-hypersensitivity-reactions-and-respiratory-symptoms_en.pdf"},
    {"id":"18807","name":"EU/3/03/155: Public summary of positive opinion for orphan designation of murine anti-idiotypic antibody against OC125 antibody against CA125 antigen for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T01:00:00Z","last_updated_date":"2014-01-13T15:30:00Z","reference_number":"EMEA/COMP/1376/03 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303155-public-summary-positive-opinion-orphan-designation-murine-anti-idiotypic-antibody-against-oc125-antibody-against-ca125-antigen-treatment-ovarian-cancer_en.pdf"},
    {"id":"18808","name":"List of participants - Second stakeholders forum on the implementation\n\nof the new pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:10Z","last_updated_date":"2011-06-24T22:06:10Z","reference_number":"EMA/451672/2011","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-second-stakeholders-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"18811","name":"EU/3/16/1743: Public summary of positive opinion for orphan designation of autologous mononuclear cells derived from human cord blood for the treatment of neonatal encephalopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/629725/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161743-public-summary-positive-opinion-orphan-designation-autologous-mononuclear-cells-derived-human-cord-blood-treatment-neonatal-encephalopathy_en.pdf"},
    {"id":"18812","name":"Presentation - Novel regulatory sience research on drugs for Alzheimer's disease - a guideline on the clinical evaluation of drugs for Alzheimer’s disease (Interim report) (Takashi Moritoyo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-novel-regulatory-sience-research-drugs-alzheimers-disease-guideline-clinical-evaluation-drugs-alzheimers-disease-interim-report-takashi-moritoyo_en.pdf"},
    {"id":"18813","name":"Public statement on Rayzon (parecoxib) - withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-08-23T14:09:21Z","last_updated_date":"2005-08-23T14:09:21Z","reference_number":"EMEA/265596/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-rayzon-parecoxib-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"18816","name":"Scientific recommendation on classification of advanced therapy medicinal products: Full-thickness human skin substitute composed of an epidermal layer of fully-stratified human keratinocytes and a collagen-rich dermal e...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:41:00Z","last_updated_date":"2018-01-03T14:41:00Z","reference_number":"EMA/751554/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-full-thickness-human-skin-substitute-composed-epidermal-layer-fully-stratified-human-keratinocytes-and-collagen-rich-dermal_en.pdf"},
    {"id":"18818","name":"Superseded assessment report on Ruscus aculeatus L., rhizoma","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2019-05-02T17:00:00Z","reference_number":"EMEA/HMPC/261939/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-ruscus-aculeatus-l-rhizoma_en.pdf"},
    {"id":"18819","name":"Declaration of interests: Isabelle Moulon","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:20Z","last_updated_date":"2016-09-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-isabelle-moulon_en.pdf"},
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    {"id":"18829","name":"PRAC recommends updating advice on use of high-dose ibuprofen","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-04-13T12:00:00Z","last_updated_date":"2015-04-13T12:00:00Z","reference_number":"EMA/217862/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-updating-advice-use-high-dose-ibuprofen_en.pdf"},
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    {"id":"18834","name":"Diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed): List of nationally authorised medicinal products - PSUSA/00001124/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T12:35:00Z","last_updated_date":"2018-07-19T12:35:00Z","reference_number":"EMA/495687/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheria-tetanus-pertussis-acellular-component-poliomyelitis-inactivated-haemophilus-type-b-conjugate-vaccine-adsorbed-list-nationally-authorised-medicinal-products-psusa00001124201711_en.pdf"},
    {"id":"18835","name":"Celgene Europe Limited withdraws its marketing authorisation application for Lenalidomide Celgene Europe (lenalidomide)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-04T02:00:00Z","last_updated_date":"2008-06-04T02:00:00Z","reference_number":"EMEA/291600/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/celgene-europe-limited-withdraws-its-marketing-authorisation-application-lenalidomide-celgene-europe-lenalidomide_en.pdf"},
    {"id":"18837","name":"EU/3/12/1077 : Public summary of opinion on orphan designation: Exon-52-specific phosphorothioate oligonucleotide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2013-01-25T12:00:00Z","reference_number":"EMA/COMP/740574/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121077-public-summary-opinion-orphan-designation-exon-52-specific-phosphorothioate-oligonucleotide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"18838","name":"Presentation - How have eligible products benefited from PRIME so far? (Jordi Llinares Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-07T02:00:00Z","last_updated_date":"2017-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-have-eligible-products-benefited-prime-so-far-jordi-llinares-garcia_en.pdf"},
    {"id":"18839","name":"European Medicines Agency starts review of rosiglitazone-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-09T02:00:00Z","last_updated_date":"2010-07-09T02:00:00Z","reference_number":"EMA/425166/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-rosiglitazone-containing-medicines_en.pdf"},
    {"id":"18840","name":"Presentation - Persistent pulmonary hypertension (PPHN) of the newborn: clinical vs regulatory needs (Marek Migdal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-persistent-pulmonary-hypertension-pphn-newborn-clinical-vs-regulatory-needs-marek-migdal_en.pdf"},
    {"id":"18841","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic engineered Chimeric Antigen Receptor (CAR+) T-cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-06-04T19:00:00Z","last_updated_date":"2014-06-04T19:00:00Z","reference_number":"EMA/326383/2014","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-engineered-chimeric-antigen-receptor-car-t-cells_en.pdf"},
    {"id":"18842","name":"Final European Union recommendation for influenza-vaccine composition for the season 2003 / 2004","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-03-19T00:09:21Z","last_updated_date":"2002-03-19T00:09:21Z","reference_number":"CPMP/BWP/6011/03","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/final-european-union-recommendation-influenza-vaccine-composition-season-2003-2004_en.pdf"},
    {"id":"18843","name":"European Medicines Agency breach of trust procedure on declarations of competing interests for Management Board members","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-06-21T17:00:00Z","last_updated_date":"2023-01-04T10:08:00Z","reference_number":"EMA/MB/309079/2012 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-breach-trust-procedure-declarations-competing-interests-management-board-members_en.pdf"},
    {"id":"18844","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose-derived stem cells seeded on a collagen matrix scaffold","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/65631/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-adipose-derived-stem-cells-seeded-collagen-matrix-scaffold_en.pdf"},
    {"id":"18847","name":"Reflection paper on water for injection prepared by reverse osmosis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-03-05T01:00:00Z","last_updated_date":"2008-03-05T01:00:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/28271/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-water-injection-prepared-reverse-osmosis_en.pdf"},
    {"id":"18848","name":"Questions and answers on Targocid and associated names (teicoplanin, powder or powder and solvent for solution for injection, infusion or oral solution, 100, 200 and 400 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    {"id":"18894","name":"Work instructions for management of the procedure for assessment of the final report of Post-Authorisation Safety Studies (PASS) for veterinary medicines","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2016-04-04T14:15:00Z","last_updated_date":"2016-04-04T14:15:00Z","reference_number":"WIN/V/4028","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-management-procedure-assessment-final-report-post-authorisation-safety-studies-pass-veterinary-medicines_en.pdf"},
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    {"id":"18899","name":"Agenda - Information meeting on participation of Croatia and Turkey in EMEA activities in 2006 and 2007","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-09-29T02:09:21Z","last_updated_date":"2006-09-29T02:09:21Z","reference_number":"EMEA/380958/2006","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-information-meeting-participation-croatia-and-turkey-emea-activities-2006-and-2007_en.pdf"},
    {"id":"18901","name":"Valproate - Article 31 - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-04-29T02:00:00Z","last_updated_date":"2011-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valproate-article-31-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valproate-article-31-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valproate-article-31-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valproate-article-31-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valproate-article-31-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valproate-article-31-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valproate-article-31-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valproate-article-31-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valproate-article-31-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valproate-article-31-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valproate-article-31-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valproate-article-31-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valproate-article-31-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valproate-article-31-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valproate-article-31-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valproate-article-31-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valproate-article-31-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valproate-article-31-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valproate-article-31-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valproate-article-31-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valproate-article-31-annex-iii_sv.pdf"}},
    {"id":"18902","name":"Presentation - Strengthening the prospective discussions on post-licensing evidence generation (J. Moseley, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-23T01:00:00Z","last_updated_date":"2017-11-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-prospective-discussions-post-licensing-evidence-generation-j-moseley-ema_en.pdf"},
    {"id":"18903","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Pimpinella anisum L., aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-06-18T02:00:00Z","last_updated_date":"2014-06-18T02:00:00Z","reference_number":"EMEA/HMPC/695922/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-pimpinella-anisum-l-aetheroleum_en.pdf"},
    {"id":"18904","name":"Public statement on supply of Norvir hard capsules","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1998-07-28T02:00:00Z","last_updated_date":"1998-07-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-supply-norvir-hard-capsules_en.pdf"},
    {"id":"18905","name":"Pharmaceutical forum working group on information to patients: report on pillar II: statutory information on medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2006-10-10T02:00:00Z","last_updated_date":"2006-10-10T02:00:00Z","reference_number":"EMEA/109974/2006","document_url":"https://www.ema.europa.eu/en/documents/report/pharmaceutical-forum-working-group-information-patients-report-pillar-ii-statutory-information-medicines_en.pdf"},
    {"id":"18906","name":"Presentation - Immunogenicity of biological therapeutics product quality attributes (Susan Kirshner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunogenicity-biological-therapeutics-product-quality-attributes-susan-kirshner_en.pdf"},
    {"id":"18907","name":"Guideline on good pharmacovigilance practices: Module X – Additional monitoring with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-04-25T12:00:00Z","last_updated_date":"2013-04-25T12:00:00Z","reference_number":"EMA/237329/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-x-additional-monitoring-tracked-changes_en.pdf"},
    {"id":"18911","name":"European Medicines Agency reorganisation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/277449/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-reorganisation_en.pdf"},
    {"id":"18912","name":"Bronopol: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-06-01T02:00:00Z","last_updated_date":"2001-06-01T02:00:00Z","reference_number":"EMEA/MRL/791/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bronopol-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18914","name":"Agenda - A common data model for Europe? – Why? Which? How?","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-10-31T15:10:00Z","last_updated_date":"2017-12-12T13:00:00Z","reference_number":"EMA/550682/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-common-data-model-europe-why-which-how_en.pdf"},
    {"id":"18916","name":"Presentation - Reflections and experiences of healthcare professionals on the implementation of the directive so far (Jurate Svarcaite)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reflections-and-experiences-healthcare-professionals-implementation-directive-so-far-jurate-svarcaite_en.pdf"},
    {"id":"18918","name":"EU/3/01/019: Public summary of positive opinion for orphan designation of bosentan for the treatment of pulmonary arterial hypertension and chronic  thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:00:00Z","last_updated_date":"2013-02-27T15:00:00Z","reference_number":"EMEA/COMP/1280/2003 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301019-public-summary-positive-opinion-orphan-designation-bosentan-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"18920","name":"Public summary of negative opinion on orphan designation: 20% intravenous fat emulsion consisting of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/211260/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-20-intravenous-fat-emulsion-consisting-20-soybean-oil-12-egg-yolk-phospholipids-225-glycerin-and-water-injection_en.pdf"},
    {"id":"18922","name":"Agenda - Eighth stakeholders forum on the implementation of the new pharmacovigilance legislation: Building on two years of operation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"EMA/449800/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eighth-stakeholders-forum-implementation-new-pharmacovigilance-legislation-building-two-years-operation_en.pdf"},
    {"id":"18923","name":"Corticorelin: List of nationally authorised medicinal products - PSUSA/00000876/201410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T14:00:00Z","last_updated_date":"2016-10-17T20:37:50Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/corticorelin-list-nationally-authorised-medicinal-products-psusa00000876201410_en.pdf"},
    {"id":"18927","name":"Stakeholder engagement report 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T13:00:00Z","last_updated_date":"2018-06-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/stakeholder-engagement-report-2017_en.pdf"},
    {"id":"18929","name":"CHMP position statement on Creutzfeldt-Jacob disease and plasma-derived and urine-derived medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-23T02:00:00Z","last_updated_date":"2004-06-23T02:00:00Z","reference_number":"EMEA/CPMP/BMP/2879/02/ rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/chmp-position-statement-creutzfeldt-jacob-disease-and-plasma-derived-and-urine-derived-medicinal-products-revision-1_en.pdf"},
    {"id":"18930","name":"Proposal for an international registry for juvenile idiopathic arthritis patients treated with methotrexate, Dr Nicolino Ruperto","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/proposal-international-registry-juvenile-idiopathic-arthritis-patients-treated-methotrexate-dr-nicolino-ruperto_en.pdf"},
    {"id":"18931","name":"Overview of comments received on the Committee for Medicinal Products for Veterinary Use strategy on antimicrobials 2011-2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-25T03:00:00Z","last_updated_date":"2011-07-25T03:00:00Z","reference_number":"EMA/CVMP/257610/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-committee-medicinal-products-veterinary-use-strategy-antimicrobials-2011-2015_en.pdf"},
    {"id":"18933","name":"CHMP post-authorisation summary of positive opinion for Abseamed","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/503859/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abseamed_en.pdf"},
    {"id":"18935","name":"Inventory of paediatric therapeutic needs - Endocrinology","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2015-08-19T18:10:00Z","last_updated_date":"2015-08-19T18:10:00Z","reference_number":"EMA/PDCO/52553/2015","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-therapeutic-needs-endocrinology_en.pdf"},
    {"id":"18937","name":"Terpenic derivatives - Article 31 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-02-08T01:00:00Z","last_updated_date":"2012-02-08T01:00:00Z","reference_number":"EMEA/H/A-1284","document_url":"https://www.ema.europa.eu/en/documents/referral/terpenic-derivatives-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/terpenic-derivatives-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/terpenic-derivatives-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/terpenic-derivatives-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/terpenic-derivatives-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/terpenic-derivatives-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/terpenic-derivatives-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/terpenic-derivatives-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/terpenic-derivatives-article-31-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/terpenic-derivatives-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/terpenic-derivatives-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/terpenic-derivatives-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/terpenic-derivatives-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/terpenic-derivatives-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/terpenic-derivatives-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/terpenic-derivatives-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/terpenic-derivatives-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/terpenic-derivatives-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/terpenic-derivatives-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/terpenic-derivatives-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/terpenic-derivatives-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/terpenic-derivatives-article-31-referral-annex-i_sv.pdf"}},
    {"id":"18938","name":"Minutes of the European Network of Paediatric Research at the European Medicines Agency Coordinating Group meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-10-23T13:25:00Z","last_updated_date":"2013-10-23T13:25:00Z","reference_number":"EMA/543361/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-agency-coordinating-group-meeting_en.pdf"},
    {"id":"18939","name":"Presentation - Organisations Management Services (OMS) project report (Kepa Amutxastegi, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-organisations-management-services-oms-project-report-kepa-amutxastegi-ema_en.pdf"},
    {"id":"18941","name":"Update on somatropin-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-16T02:00:00Z","last_updated_date":"2010-12-16T02:00:00Z","reference_number":"EMA/CHMP/820649/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-somatropin-containing-medicines_en.pdf"},
    {"id":"18946","name":"Febantel: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-06-01T02:00:00Z","last_updated_date":"1997-06-01T02:00:00Z","reference_number":"EMEA/MRL/192/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/febantel-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18949","name":"Presentation - How patients and healthcare professionals can be involved in public hearings (J. Garcia Burgos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patients-and-healthcare-professionals-can-be-involved-public-hearings-j-garcia-burgos-ema_en.pdf"},
    {"id":"18951","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-03-02T01:00:00Z","last_updated_date":"2016-06-23T15:30:00Z","reference_number":"EMA/855288/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf-0"},
    {"id":"18952","name":"18th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1997-02-12T13:40:00Z","last_updated_date":"1997-02-12T13:40:00Z","reference_number":"EMEA/CVMP/059/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/18th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"18955","name":"Presentation - The future clinical trial authorisation process: the new evaluation process (Massimiliano Sarra)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T12:14:00Z","last_updated_date":"2017-03-30T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-future-clinical-trial-authorisation-process-new-evaluation-process-massimiliano-sarra_en.pdf"},
    {"id":"18956","name":"Guidelines and concept papers: Adopted during the CHMP meeting 13-16 February 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T18:50:00Z","last_updated_date":"2012-02-17T18:50:00Z","reference_number":"EMA/CHMP/86231/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-13-16-february-2012_en.pdf"},
    {"id":"18957","name":"Presentation - Data monitoring committee member experience: Studies with an adaptive design/confidentiality","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-monitoring-committee-member-experience-studies-adaptive-designconfidentiality_en.pdf"},
    {"id":"18959","name":"CHMP summary of positive opinion for Elonva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/CHMP/362887/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-elonva_en.pdf"},
    {"id":"18960","name":"Overview of comments received on the draft ‘Questions and answers on wheat starch (containing gluten)’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/674221/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-questions-and-answers-wheat-starch-containing-gluten_en.pdf"},
    {"id":"18962","name":"CHMP summary of positive opinion for Vibativ","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-19T13:00:00Z","last_updated_date":"2018-05-16T13:00:00Z","reference_number":"EMA/CHMP/399709/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vibativ_en.pdf"},
    {"id":"18963","name":"14th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-06-13T02:00:00Z","last_updated_date":"2001-06-13T02:00:00Z","reference_number":"COMP/243/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/14th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"18965","name":"Presentation – Multiple sclerosis workshop - Pre-work package","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multiple-sclerosis-workshop-pre-work-package_en.pdf"},
    {"id":"18967","name":"European Medicines Agency starts review of ibuprofen medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T17:00:00Z","last_updated_date":"2014-06-13T17:00:00Z","reference_number":"EMA/348597/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-ibuprofen-medicines_en.pdf"},
    {"id":"18968","name":"Superseded overview of comments received on Community herbal monograph on Tanacetum parthenium (L) Schulz Bip., herba - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-06-20T02:00:00Z","last_updated_date":"2020-08-14T02:00:00Z","reference_number":"EMA/HMPC/563270/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-tanacetum-parthenium-l-schulz-bip-herba-first-version_en.pdf"},
    {"id":"18972","name":"Draft list of references supporting the assessment of Ruscus aculeatus L. rhizoma - Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2018-03-08T09:30:00Z","last_updated_date":"2018-03-08T09:30:00Z","reference_number":"EMA/188806/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-ruscus-aculeatus-l-rhizoma-revision-1_en.pdf"},
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    {"id":"18988","name":"Sultamicillin: List of nationally authorised medicinal products - PSUSA/00002829/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-15T12:00:00Z","last_updated_date":"2016-10-18T11:56:10Z","reference_number":"EMA/492708/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/sultamicillin-list-nationally-authorised-medicinal-products-psusa00002829201511_en.pdf"},
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    {"id":"19006","name":"CHMP summary of positive opinion for Dasselta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/614045/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dasselta_en.pdf"},
    {"id":"19009","name":"Presentation -  Adaptive pathways: patient safety at risk?\n\n (Francesca Cattarin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adaptive-pathways-patient-safety-risk-francesca-cattarin_en.pdf"},
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    {"id":"19016","name":"ICT service desk EMA/2013/09/ICT - Annex B - Off-the-shelf applications in use at EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-28T02:00:00Z","last_updated_date":"2013-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ict-service-desk-ema201309ict-annex-b-shelf-applications-use-ema_en.pdf"},
    {"id":"19024","name":"Declaration of interests: Patrick Le Courtois","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:10Z","last_updated_date":"2012-08-03T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-patrick-le-courtois_en.pdf"},
    {"id":"19025","name":"Paracetamol Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-notification_en.pdf"},
    {"id":"19028","name":"Worldwide Orphan Medicinal Designation workshop 10 March 2014 - Wrap up of the event","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"EMA/167060/2014","document_url":"https://www.ema.europa.eu/en/documents/other/worldwide-orphan-medicinal-designation-workshop-10-march-2014-wrap-event_en.pdf"},
    {"id":"19029","name":"EU/3/08/541: Public summary of positive opinion for orphan designation of [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone for the treatment of erythropoietic protoporphyria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMEA/COMP/160599/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308541-public-summary-positive-opinion-orphan-designation-nle4-d-phe7-alpha-melanocyte-stimulating-hormone-treatment-erythropoietic-protoporphyria_en.pdf"},
    {"id":"19032","name":"Roxithromycin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"19073","name":"CHMP post-authorisation summary of positive opinion for Zebinix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"EMA/CHMP/824232/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zebinix_en.pdf"},
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    {"id":"19079","name":"Agenda for the 91st meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-03-16T16:10:00Z","last_updated_date":"2016-03-18T16:25:00Z","reference_number":"EMA/MB/266/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-91st-meeting-management-board_en.pdf"},
    {"id":"19082","name":"Estradiol (without cream/balm/emulsion for application in the female genital area): List of nationally authorised medicinal products - PSUSA/00010440/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T16:00:00Z","last_updated_date":"2017-05-12T16:00:00Z","reference_number":"EMA/269084/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/estradiol-without-creambalmemulsion-application-female-genital-area-list-nationally-authorised-medicinal-products-psusa00010440201608_en.pdf"},
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    {"id":"19084","name":"Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-06-01T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/62470/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-qrd-convention-be-followed-european-medicines-agency-qrd-templates_en.pdf"},
    {"id":"19087","name":"Teicoplanin: List of nationally authorised medicinal products - PSUSA/00002878/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-11T11:17:00Z","last_updated_date":"2017-07-11T11:19:15Z","reference_number":"EMA/438097/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/teicoplanin-list-nationally-authorised-medicinal-products-psusa00002878201611_en.pdf"},
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    {"id":"19089","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 5-7 December 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-12-18T18:00:01Z","last_updated_date":"2013-01-17T15:30:00Z","reference_number":"EMA/PDCO/764589/2012 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-5-7-december-2012_en.pdf"},
    {"id":"19090","name":"EU/3/08/611: Public summary of positive opinion for orphan designation of recombinant human hepatocarcinoma-intestine-pancreas / pancreatic associated protein for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/668440/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308611-public-summary-positive-opinion-orphan-designation-recombinant-human-hepatocarcinoma-intestine-pancreas-pancreatic-associated-protein-treatment-acute-liver-failure_en.pdf"},
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    {"id":"19102","name":"Draft guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"CHMP/EWP/1343/01 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-antifungal-agents-treatment-and-prophylaxis-invasive-fungal-disease_en.pdf"},
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    {"id":"19108","name":"Acetylisovaleryltylosin: Summary Report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-07-01T02:00:00Z","last_updated_date":"2004-07-01T02:00:00Z","reference_number":"EMEA/MRL/909/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/acetylisovaleryltylosin-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19109","name":"Public statement on Prevenar (pneumococcal polysaccharide conjugate vaccine (7-valent, adsorbed)): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2017-11-24T17:03:00Z","last_updated_date":"2017-11-24T17:03:00Z","reference_number":"EMA/751589/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-prevenar-pneumococcal-polysaccharide-conjugate-vaccine-7-valent-adsorbed-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"19111","name":"International Coalition of Medicines Regulatory Authorities (ICMRA) Ebola press release: medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potent...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-11T12:00:00Z","last_updated_date":"2016-02-11T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/international-coalition-medicines-regulatory-authorities-icmra-ebola-press-release-medicines-regulators-work-together-internationally-find-innovative-solutions-facilitate-evaluation-and-access-potent_en.pdf"},
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    {"id":"19135","name":"Presentation - Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) – work package (WP) 5: Extension / validation of benefit-risk methods, tools and processes evaluated in PROTE...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T17:00:00Z","last_updated_date":"2013-07-18T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacoepidemiological-research-outcomes-therapeutics-european-consortium-protect-work-package-wp-5-extension-validation-benefit-risk-methods-tools-and-processes-evaluated-prote_en.pdf"},
    {"id":"19136","name":"EU/3/12/977: Public summary of opinion on orphan designation: Linsitinib for the treatment of adrenal cortical carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2013-03-11T16:30:00Z","reference_number":"EMA/COMP/142178/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312977-public-summary-opinion-orphan-designation-linsitinib-treatment-adrenal-cortical-carcinoma_en.pdf"},
    {"id":"19137","name":"Committee for medicinal products for veterinary use: Meeting of 10-12 March 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-13T00:09:21Z","last_updated_date":"2009-03-13T00:09:21Z","reference_number":"EMEA/CVMP/126568/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-10-12-march-2009_en.pdf"},
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    {"id":"19140","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Aqueous suspension of attenuated Salmonella typhi Ty21a strain transfected with a plasmid vector encoding for the human vascular endothe...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T13:30:00Z","last_updated_date":"2013-03-08T13:30:00Z","reference_number":"EMA/49924/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-aqueous-suspension-attenuated-salmonella-typhi-ty21a-strain-transfected-plasmid-vector-encoding-human-vascular-endothe_en.pdf"},
    {"id":"19142","name":"European Medicines Agency launches a new version of EudraCT","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"EMA/563462/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-new-version-eudract_en.pdf"},
    {"id":"19143","name":"EU/3/01/072: Public summary of positive opinion for orphan designation of apomorphine (oromucosal use) for the treatment of off-periods in Parkinson’s disease not responding adequately to other existing therapies","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-03T00:00:00Z","last_updated_date":"2011-06-01T01:00:00Z","reference_number":"EMEA/COMP/209/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301072-public-summary-positive-opinion-orphan-designation-apomorphine-oromucosal-use-treatment-periods-parkinsons-disease-not-responding-adequately-other-existing-therapies_en.pdf"},
    {"id":"19145","name":"Presentation - DOACs: the patient perspective (Christine Dehn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-doacs-patient-perspective-christine-dehn_en.pdf"},
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    {"id":"19151","name":"Presentation - Rob Hemmings preliminary comments - Break-out session 4 theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rob-hemmings-preliminary-comments-break-out-session-4-theme-2_en.pdf"},
    {"id":"19153","name":"Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species/limited markets - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"EMA/CVMP/IWP/123243/2006-Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-immunological-veterinary-medicinal-products-intended-minor-use-or-minor-specieslimited-markets-revision-2_en.pdf"},
    {"id":"19154","name":"Josamycin (Chicken): Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/011/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/josamycin-chicken-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"19215","name":"Presentation - POS (Partial onset seizures) Extrapolation from adults to  children Clinical setting (Catherine Chiron, Gerard Pons)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pos-partial-onset-seizures-extrapolation-adults-children-clinical-setting-catherine-chiron-gerard-pons_en.pdf"},
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    {"id":"19218","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 April 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-04-18T02:00:00Z","last_updated_date":"2017-04-18T02:00:00Z","reference_number":"EMA/CVMP/215817/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-april-2017_en.pdf"},
    {"id":"19220","name":"Draft list of references supporting the assessment of Primula veris L. and / or Primula elatior (L.) Hill, flos","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMEA/HMPC/111633/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-primula-veris-l-and-or-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"19221","name":"Diclazuril (Rabbits): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T17:30:00Z","last_updated_date":"2014-02-20T17:30:00Z","reference_number":"EMA/CVMP/605156/20123","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diclazuril-rabbits-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
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    {"id":"19227","name":"Croatia - Veterinary Directorate, S Separovic","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/croatia-veterinary-directorate-s-separovic_en.pdf"},
    {"id":"19229","name":"European Medicines Agency recommends restricting use of Pandemrix","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-07-21T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/CHMP/568830/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-pandemrix_en.pdf"},
    {"id":"19231","name":"Common Repository for all veterinary submissions in the centralised procedure – statement of intent","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T12:45:00Z","last_updated_date":"2016-11-25T12:45:00Z","reference_number":"EMA/715059/2016","document_url":"https://www.ema.europa.eu/en/documents/other/common-repository-all-veterinary-submissions-centralised-procedure-statement-intent_en.pdf"},
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    {"id":"19239","name":"List of references supporting the assessment of Juglans regia L., folium","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2014-01-17T01:00:00Z","last_updated_date":"2014-01-17T01:00:00Z","reference_number":"EMA/HMPC/346742/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-juglans-regia-l-folium_en.pdf"},
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    {"id":"19243","name":"Standard Operating Procedure for Template for Assessment Report","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-02-08T01:00:00Z","last_updated_date":"2007-02-08T01:00:00Z","reference_number":"EMEA/INS/GMP/75469/2007","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-template-assessment-report_en.doc"},
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    {"id":"19249","name":"1-Methyl-2-pyrrolidone: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-09-01T02:00:00Z","last_updated_date":"1998-09-01T02:00:00Z","reference_number":"EMEA/MRL/493/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/1-methyl-2-pyrrolidone-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"19253","name":"Guideline on good pharmacovigilance practices: Module V – Risk management systems with tracked changes (Rev. 2)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T17:00:00Z","last_updated_date":"2017-03-30T17:00:00Z","reference_number":"EMA/838713/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-tracked-changes-rev-2_en.pdf"},
    {"id":"19255","name":"Symphyti radix: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/649/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/symphyti-radix-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19258","name":"High level business consultancy EMA/2013/23/FI - Technical specifications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"EMA/552750/2013","document_url":"https://www.ema.europa.eu/en/documents/other/high-level-business-consultancy-ema201323fi-technical-specifications_en.pdf"},
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    {"id":"19261","name":"Oleyloleate: Summary Report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/445/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oleyloleate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19262","name":"Overview of comments received on ‘draft sirolimus product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116630/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-sirolimus-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"19263","name":"Agenda and registration form - European Medicines Agency excellence in pharmacovigilance: Clinical trials and post-marketing training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-09-06T02:00:00Z","last_updated_date":"2012-09-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-european-medicines-agency-excellence-pharmacovigilance-clinical-trials-and-post-marketing-training-course_en.pdf"},
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    {"id":"19318","name":"CHMP meeting dates 2021, 2022, 2023 and 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-04-06T14:28:00Z","last_updated_date":"2021-04-06T14:28:00Z","reference_number":"EMA/90608/2021","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2021-2022-2023-and-2024_en.pdf"},
    {"id":"19319","name":"EU/3/01/022: Public summary of positive opinion for orphan designation of laronidase for the treatment of mucopolysaccharidosis, type I","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2013-07-08T02:00:00Z","reference_number":"EMEA/COMP/1279/03 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301022-public-summary-positive-opinion-orphan-designation-laronidase-treatment-mucopolysaccharidosis-type-i_en.pdf"},
    {"id":"19321","name":"Ticlopidine: List of nationally authorised medicinal products - PSUSA/00002952/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-10T11:00:00Z","last_updated_date":"2016-10-18T19:12:23Z","reference_number":"EMA/183015/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ticlopidine-list-nationally-authorised-medicinal-products-psusa00002952201505_en.pdf"},
    {"id":"19323","name":"Presentation - Overview of good-pharmacovigilance-practice modules V (risk-management systems) and VIII (post-authorisation safety studies), and the European Network of Centres for Pharmacoepidemiology and Pharmacovigila...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-good-pharmacovigilance-practice-modules-v-risk-management-systems-and-viii-post-authorisation-safety-studies-and-european-network-centres-pharmacoepidemiology-and-pharmacovigila_en.pdf"},
    {"id":"19325","name":"ICH: E 16: Note for guidance on genomic biomarkers related to drug response: context, structure and format of qualification submissions - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-06-01T02:00:00Z","last_updated_date":"2009-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/380636/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-16-note-guidance-genomic-biomarkers-related-drug-response-context-structure-and-format-qualification-submissions-step-3_en.pdf"},
    {"id":"19327","name":"Presentation - Reproductive toxicity: An introduction to regulatory aspects on detection of toxicity to reproduction for medicinal products (Gà¼nter Waxenecker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T18:12:00Z","last_updated_date":"2016-10-26T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reproductive-toxicity-introduction-regulatory-aspects-detection-toxicity-reproduction-medicinal-products-ga-14nter-waxenecker_en.pdf"},
    {"id":"19328","name":"CHMP positive summary of opinion for Clopidogrel Teva Generics B.V.","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/CHMP/455692/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-clopidogrel-teva-generics-bv_en.pdf"},
    {"id":"19330","name":"Revised framework for interaction between the European Medicines Agency and healthcare professionals - Annex I – Action plan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T13:00:00Z","last_updated_date":"2018-06-21T13:30:00Z","reference_number":"EMA/705066/2016","document_url":"https://www.ema.europa.eu/en/documents/other/revised-framework-interaction-between-european-medicines-agency-and-healthcare-professionals-annex-i-action-plan_en.pdf"},
    {"id":"19331","name":"Reflection paper on the new approach developed by JECFA for exposure and MRL assessment of residues of VMP","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-09-22T02:00:00Z","last_updated_date":"2008-09-22T02:00:00Z","reference_number":"EMEA/CVMP/SWP/138366/2008-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-new-approach-developed-jecfa-exposure-and-mrl-assessment-residues-vmp_en.pdf"},
    {"id":"19333","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous differentiated adipocytes derived from the subcutaneous adipose tissue","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:00:00Z","last_updated_date":"2015-08-26T12:00:00Z","reference_number":"EMA/557278/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-differentiated-adipocytes-derived-subcutaneous-adipose-tissue_en.pdf"},
    {"id":"19335","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Para-aminosalicylic acid Lucane (para-aminosalicylic acid) for the treatment of tuberculosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMA/COMP/72228/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-para-aminosalicylic-acid-lucane-para-aminosalicylic-acid-treatment-tuberculosis_en.pdf"},
    {"id":"19336","name":"Draft reflection paper on the extrapolation of results from clinical studies conducted outside Europe to the European Union population","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-02-19T01:00:00Z","last_updated_date":"2009-02-19T01:00:00Z","reference_number":"EMEA/CHMP/EWP/692702/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-extrapolation-results-clinical-studies-conducted-outside-europe-european-union-population_en.pdf"},
    {"id":"19337","name":"Presentation - New EMA shareable communications (M. Benstetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:44:00Z","last_updated_date":"2017-12-11T16:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-ema-shareable-communications-m-benstetter_en.pdf"},
    {"id":"19342","name":"COMP members interaction with sponsors of orphan designation applications","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-07-12T02:00:00Z","last_updated_date":"2020-12-16T17:00:00Z","reference_number":"EMEA/COMP/150409/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/comp-members-interaction-sponsors-orphan-designation-applications_en.pdf"},
    {"id":"19344","name":"Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T19:19:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"EMA/395730/2012 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-addendum-i-requirements-and-recommendations-submission-information-non-interventional-post-authorisation-safety-studies-rev-2_en.pdf"},
    {"id":"19347","name":"Concept paper on the development of a committee for proprietary medicinal products (CPMP) note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2001-05-21T02:00:00Z","last_updated_date":"2001-05-21T02:00:00Z","reference_number":"CPMP/EWP/512/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-proprietary-medicinal-products-cpmp-note-guidance-evaluation-medicinal-products-treatment-dyslipoproteinaemia_en.pdf"},
    {"id":"19351","name":"EU-RMP Annex I manual - Electronic interface for EudraVigilance (Version 5.1 – October 2013)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-07-07T02:00:00Z","reference_number":"Version 5.1 – October 2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eu-rmp-annex-i-manual-electronic-interface-eudravigilance-version-51-october-2013_en.pdf"},
    {"id":"19353","name":"EMEA holds first meeting of Committee for Advanced Therapies (CAT)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-01-16T00:00:00Z","last_updated_date":"2009-01-16T00:00:00Z","reference_number":"EMEA/7866/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-holds-first-meeting-committee-advanced-therapies-cat_en.pdf"},
    {"id":"19354","name":"Comments on Revision of Clinical Trials Directive 2001-20\n\nOn behalf of the European network of paediatric research at the EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T17:45:00Z","last_updated_date":"2014-03-21T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comments-revision-clinical-trials-directive-2001-20-behalf-european-network-paediatric-research-ema_en.pdf"},
    {"id":"19355","name":"Presentation - MAH compliance with PRAC signal recommendations for PI update of CAPs (Aniello Santoro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T17:30:00Z","last_updated_date":"2017-03-30T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mah-compliance-prac-signal-recommendations-pi-update-caps-aniello-santoro_en.pdf"},
    {"id":"19356","name":"Presentation - PML: Risk communication in the EU, Rafe Suvarna","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pml-risk-communication-eu-rafe-suvarna_en.pdf"},
    {"id":"19359","name":"Committee for Orphan Medicinal Products: May 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-05-18T02:00:00Z","last_updated_date":"2005-05-18T02:00:00Z","reference_number":"EMEA/COMP/162001/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-may-2005-meeting_en.pdf"},
    {"id":"19360","name":"Guidelines and concept papers adopted at the CHMP meeting of 16-19 December 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/730954/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-chmp-meeting-16-19-december-2013_en.pdf"},
    {"id":"19361","name":"Presentation - Conclusions - Training session for patients and consumers involved in EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-conclusions-training-session-patients-and-consumers-involved-ema_en.pdf"},
    {"id":"19362","name":"Questions and answers on the review of calcitonin-containing medicines - Outcome of re-examination","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-calcitonin-containing-medicines-outcome-re-examination_en.pdf"},
    {"id":"19363","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro derived platelets","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:00:00Z","last_updated_date":"2015-08-26T12:00:00Z","reference_number":"EMA/556370 /2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-derived-platelets_en.pdf"},
    {"id":"19364","name":"Superseded opinion of the HMPC on a Community herbal monograph on Mentha x piperita L., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/189852/2008/EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-mentha-x-piperita-l-folium_en.pdf"},
    {"id":"19366","name":"Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-08-02T02:00:00Z","last_updated_date":"2010-08-02T02:00:00Z","reference_number":"EMA/CHMP/BPWP/94033/2007 rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-revision-2_en.pdf"},
    {"id":"19368","name":"Presentation - Day 2: Dry eye disease: a tear film and ocular surface challenge","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-dry-eye-disease-tear-film-and-ocular-surface-challenge_en.pdf"},
    {"id":"19370","name":"European Medicines Agency concludes that benefit-risk balance of Invirase remains positive","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-10-21T02:00:00Z","last_updated_date":"2010-10-21T02:00:00Z","reference_number":"EMA/CHMP/648226/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-benefit-risk-balance-invirase-remains-positive_en.pdf"},
    {"id":"19372","name":"Tiludronic acid (extension to poultry species): European Public MRL Assessment Report (EPMAR) – Committee for Medicinal Products for Veterinary use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2009-06-30T02:00:00Z","last_updated_date":"2009-06-30T02:00:00Z","reference_number":"EMEA/CVMP/92734/2008","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tiludronic-acid-extension-poultry-species-european-public-mrl-assessment-report-epmar-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"19373","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Olysio Annex I-III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T01:00:00Z","last_updated_date":"2017-03-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-olysio-annex-i-iii_no.pdf"}},
    {"id":"19375","name":"Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-14T02:00:00Z","last_updated_date":"2016-10-18T11:46:17Z","reference_number":"EMA/415297/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylphenidate-list-nationally-authorised-medicinal-products-psusa00002024201510_en.pdf"},
    {"id":"19376","name":"European Medicines Agency recommends restricted use and strengthened warnings for Ketek","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-03-30T02:00:00Z","last_updated_date":"2007-03-30T02:00:00Z","reference_number":"EMEA/129901/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricted-use-and-strengthened-warnings-ketek_en.pdf"},
    {"id":"19378","name":"Request form - Expression of interest to participate in the information sharing pilot for the evaluation of generic drug applications involving the centralised procedure of the European Union","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-01-19T15:00:00Z","last_updated_date":"2015-01-19T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-form-expression-interest-participate-information-sharing-pilot-evaluation-generic-drug-applications-involving-centralised-procedure-european-union_en.docx"},
    {"id":"19379","name":"CHMP statistics: November 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2017-11-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-november-2017_en.pdf"},
    {"id":"19380","name":"Presentation - Cell-based medicinal product - case study 1: Cardioficticell","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cell-based-medicinal-product-case-study-1-cardioficticell_en.pdf"},
    {"id":"19381","name":"Minutes of the EMA Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-08-22T02:00:00Z","last_updated_date":"2016-08-22T02:00:00Z","reference_number":"EMA/418148/20166","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting_en.pdf"},
    {"id":"19382","name":"Amarin Neuroscience Ltd withdraws its marketing authorisation application for Ethyl Eicosapent Soft Capsules (ethyl eicosapent)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-08T01:00:00Z","last_updated_date":"2009-12-08T01:00:00Z","reference_number":"EMA/796337/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/amarin-neuroscience-ltd-withdraws-its-marketing-authorisation-application-ethyl-eicosapent-soft-capsules-ethyl-eicosapent_en.pdf"},
    {"id":"19383","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting Workshop on benefit-ris...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-12T16:00:00Z","last_updated_date":"2014-12-08T15:45:00Z","reference_number":"EMA/254724/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-workshop-benefit_en.pdf"},
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    {"id":"19432","name":"PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T14:00:00Z","last_updated_date":"2013-06-14T14:00:00Z","reference_number":"EMA/353084/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-same-cardiovascular-precautions-diclofenac-selective-cox-2-inhibitors_en.pdf"},
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    {"id":"19441","name":"Committee for veterinary medicinal products: 55th meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-05-18T02:09:21Z","last_updated_date":"2000-05-18T02:09:21Z","reference_number":"EMEA/CVMP/373/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-55th-meeting_en.pdf"},
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    {"id":"19447","name":"Overview of comments received on guideline on the documentation to be submitted for inclusion in the List of herbal substances, preparations and combinations thereof (EMEA/HMPC/107399/2005)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-24T02:09:21Z","last_updated_date":"2007-10-24T02:09:21Z","reference_number":"EMEA/HMPC/309367/2005","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-documentation-be-submitted-inclusion-list-herbal-substances-preparations-and-combinations-thereof-emeahmpc1073992005_en.pdf"},
    {"id":"19448","name":"Joint statement of the European Medicines Agency and the European Food Safety Authority on the presence of residues of phenylbutazone in horse meat","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T12:00:00Z","last_updated_date":"2013-04-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joint-statement-european-medicines-agency-and-european-food-safety-authority-presence-residues-phenylbutazone-horse-meat_en.pdf"},
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    {"id":"19451","name":"CHMP summary of positive opinion for Senshio","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2014-11-21T13:00:00Z","reference_number":"EMA/CHMP/702486/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-senshio_en.pdf"},
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    {"id":"19453","name":"Overview of comments received on 'Questions and answers on Guideline on the environmental risk assessment of medicinal products for human use' - First version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-11T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMA/CHMP/SWP/739571/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-questions-and-answers-guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf"},
    {"id":"19454","name":"Questions and answers on the positive opinion  for  Revlimid","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2007-03-22T00:09:21Z","last_updated_date":"2007-03-22T00:09:21Z","reference_number":"EMEA/121873/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-positive-opinion-revlimid_en.pdf"},
    {"id":"19455","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 July 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-07-10T17:00:00Z","last_updated_date":"2015-07-10T17:00:00Z","reference_number":"EMA/CVMP/426922/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-july-2015_en.pdf"},
    {"id":"19457","name":"Triptorelin acetate (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-03-27T16:30:00Z","last_updated_date":"2014-03-27T16:30:00Z","reference_number":"EMA/CVMP/382140/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/triptorelin-acetate-all-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"19459","name":"Declaration of interests: Riccardo Ettore","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:06:49Z","last_updated_date":"2014-02-17T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-riccardo-ettore_en.pdf"},
    {"id":"19460","name":"Follow-up recommendations from CHMP on novel influenza (H1N1) outbreak: Tamiflu (oseltamivir); Relenza (zanamivir)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/CHMP/326095/2009","document_url":"https://www.ema.europa.eu/en/documents/other/follow-recommendations-chmp-novel-influenza-h1n1-outbreak-tamiflu-oseltamivir-relenza-zanamivir_en.pdf"},
    {"id":"19461","name":"Ex ante publicity of a negotiated procedure – EMA/2016/51/COM – Evidence-based database","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-09-19T14:00:00Z","last_updated_date":"2016-09-19T14:00:00Z","reference_number":"EMA/406867/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201651com-evidence-based-database_en.pdf"},
    {"id":"19462","name":"Presentation - Signal management process (G. Genov, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-signal-management-process-g-genov-ema_en.pdf"},
    {"id":"19463","name":"Performance of the Agency’s scientific procedures;\n\nveterinary products - Management Board meeting 18 March 2010","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/MB/117221/2010","document_url":"https://www.ema.europa.eu/en/documents/other/performance-agencys-scientific-procedures-veterinary-products-management-board-meeting-18-march-2010_en.pdf"},
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    {"id":"19465","name":"EMEA passes milestone of 40th positive opinion for an orphan medicinal product","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-03T02:00:00Z","last_updated_date":"2007-07-03T02:00:00Z","reference_number":"EMEA/290061/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-passes-milestone-40th-positive-opinion-orphan-medicinal-product_en.pdf"},
    {"id":"19466","name":"CHMP post-authorisation summary of positive opinion for Enbrel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/CHMP/557917/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-enbrel_en.pdf-0"},
    {"id":"19467","name":"Presentation - Single-arm trials a good step towards faster access/reimbursement of drugs? (with an added value for ‘all’ patient…)  (Mattias Neyt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T02:00:00Z","last_updated_date":"2016-08-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-single-arm-trials-good-step-towards-faster-accessreimbursement-drugs-added-value-all-patient-mattias-neyt_en.pdf"},
    {"id":"19469","name":"Octegra Article-29(4) referral - Annex I, II and III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/octegra-article-294-referral-annex-i-ii-and-iii_is.pdf"}},
    {"id":"19471","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - October 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-11-19T00:09:21Z","last_updated_date":"2009-11-19T00:09:21Z","reference_number":"EMEA/CVMP/737551/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-october-2009_en.pdf"},
    {"id":"19474","name":"Public statement on Capecitabine SUN: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-12-22T01:00:00Z","last_updated_date":"2016-12-22T01:00:00Z","reference_number":"EMA/762623/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-capecitabine-sun-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"19475","name":"European Medicines Agency gives first opinion on compassionate use","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-22T01:00:00Z","last_updated_date":"2010-01-22T01:00:00Z","reference_number":"EMA/42438/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-first-opinion-compassionate-use_en.pdf"},
    {"id":"19477","name":"12th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-04-17T02:00:00Z","last_updated_date":"2001-04-17T02:00:00Z","reference_number":"COMP/140/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/12th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"19478","name":"Presentation - Qualification of the PBPK platform for the Intended Purpose:\n\nEFPIA comments overview (S. Y. Amy Cheung and Solange Rohou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qualification-pbpk-platform-intended-purpose-efpia-comments-overview-s-y-amy-cheung-and-solange-rohou_en.pdf"},
    {"id":"19479","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T11:35:00Z","last_updated_date":"2017-10-23T11:35:00Z","reference_number":"EMA/CAT/674185/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-october-2017_en.pdf"},
    {"id":"19482","name":"CHMP post-authorisation summary of positive opinion for Enbrel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/CHMP/557933/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-enbrel_en.pdf-1"},
    {"id":"19484","name":"EU/3/16/1693 : Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 2.7m8 containing the ChrimsonR-tdTomato gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/446355/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161693-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-27m8-containing-chrimsonr-tdtomato-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"19487","name":"EU/3/13/1191: Public summary of opinion on orphan designation:\n\nL-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser for the treatment of sarcoidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2013-10-31T01:00:00Z","reference_number":"EMA/COMP/554715/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131191-public-summary-opinion-orphan-designation-l-pyr-l-glu-l-gln-l-leu-l-glu-l-arg-l-ala-l-leu-l-asn-l-ser-l-ser-treatment-sarcoidosis_en.pdf"},
    {"id":"19488","name":"EU/3/03/156: Public summary of positive opinion for orphan designation of prasterone for the treatment of adrenal insufficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-11-07T00:00:00Z","last_updated_date":"2003-11-07T00:00:00Z","reference_number":"EMEA/COMP/1257/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303156-public-summary-positive-opinion-orphan-designation-prasterone-treatment-adrenal-insufficiency_en.pdf"},
    {"id":"19489","name":"EU/3/11/858: Public summary of positive opinion for orphan designation:  R-baclofen for the treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMA/COMP/72554/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311858-public-summary-positive-opinion-orphan-designation-r-baclofen-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"19492","name":"ICMRA - Mapping of pharmacovigilance initiatives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-01-09T13:20:00Z","last_updated_date":"2017-01-09T13:20:00Z","reference_number":"EMA/530778/2015","document_url":"https://www.ema.europa.eu/en/documents/other/icmra-mapping-pharmacovigilance-initiatives_en.pdf"},
    {"id":"19493","name":"Sandostatin LAR - Article 30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T14:00:00Z","last_updated_date":"2014-07-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sandostatin-lar-article-30-referral-annex-iii_en.pdf"},
    {"id":"19495","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Lenvima (lenvatinib) for the treatment of follicular and papillary thyroid cancers","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2015-06-29T02:00:00Z","last_updated_date":"2015-06-29T02:00:00Z","reference_number":"EMA/COMP/236650/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-lenvima-lenvatinib-treatment-follicular-and-papillary-thyroid-cancers_en.pdf"},
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    {"id":"19505","name":"Presentation - How we communicate the outcome of safety reviews (Rebecca Harding)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-24T18:30:00Z","last_updated_date":"2013-05-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-we-communicate-outcome-safety-reviews-rebecca-harding_en.pdf"},
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    {"id":"19509","name":"Induced pluripotent stem cells: Prof Marc Peschanski, I-stem, Evry, France","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/induced-pluripotent-stem-cells-prof-marc-peschanski-i-stem-evry-france_en.pdf"},
    {"id":"19510","name":"Doxylamine: List of nationally authorised medicinal products - PSUSA/00001174/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-07T10:10:00Z","last_updated_date":"2017-12-07T10:10:00Z","reference_number":"EMA/811634/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/doxylamine-list-nationally-authorised-medicinal-products-psusa00001174201704_en.pdf"},
    {"id":"19512","name":"Final assessment report on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T13:00:00Z","last_updated_date":"2014-05-12T13:00:00Z","reference_number":"EMA/HMPC/604598/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-curcuma-xanthorrhiza-roxb-c-xanthorrhiza-d-dietrich-rhizoma_en.pdf"},
    {"id":"19514","name":"European Medicines Agency reaffirms efficacy and safety of H1N1 pandemic vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-11-20T00:09:21Z","last_updated_date":"2009-11-20T00:09:21Z","reference_number":"EMEA/748707/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-reaffirms-efficacy-and-safety-h1n1-pandemic-vaccines_en.pdf"},
    {"id":"19515","name":"Withdrawal assessment report for Docetaxel Winthrop","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"EMEA/633183/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-docetaxel-winthrop_en.pdf"},
    {"id":"19516","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:00Z","last_updated_date":"2022-11-18T08:24:00Z","reference_number":"EMA/136157/2012 Rev. 32","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-pharmaceutical-dose-forms_en.xlsx"},
    {"id":"19518","name":"Hydroxyethyl starch Article-107i procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T14:10:00Z","last_updated_date":"2014-03-06T13:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/hydroxyethyl-starch-article-107i-procedure-annex-iii_no.pdf"}},
    {"id":"19520","name":"ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapter - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-12-01T01:00:00Z","last_updated_date":"2017-07-13T16:30:00Z","reference_number":"EMEA/CHMP/ICH/561176/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-3-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-test-particulate-contamination-sub-visible-particles-general-chapter-step-5_en.pdf"},
    {"id":"19522","name":"Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision of module II, launch of public consultation of P.I and information on GVP maintenance and further development","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-12T02:00:00Z","last_updated_date":"2013-04-12T02:00:00Z","reference_number":"EMA/131811/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-introductory-cover-note-last-updated-revision-module-ii-launch-public-consultation-pi-and-information-gvp-maintenance-and-further-development_en.pdf"},
    {"id":"19523","name":"Targocid Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-03T01:00:00Z","last_updated_date":"2014-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/targocid-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/targocid-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/targocid-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/targocid-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/targocid-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/targocid-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/targocid-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/targocid-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/targocid-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/targocid-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/targocid-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/targocid-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/targocid-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/targocid-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/targocid-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/targocid-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/targocid-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/targocid-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/targocid-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/targocid-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/targocid-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/targocid-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/targocid-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"19526","name":"Questions and Answers on the EMEA review of cardiovascular and gastrointestinal safety and serious skin reactions with non-selective NSAIDs","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2005-10-17T02:00:00Z","last_updated_date":"2005-10-17T02:00:00Z","reference_number":"EMEA/300095/2005","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-emea-review-cardiovascular-and-gastrointestinal-safety-and-serious-skin-reactions-non-selective-nsaids_en.pdf"},
    {"id":"19528","name":"CHMP summary of positive opinion for Zinforo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/405738/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zinforo_en.pdf"},
    {"id":"19531","name":"EU/3/15/1509: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 9 containing the human SMN gene for the treatment of spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"EMA/COMP/351110/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151509-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-containing-human-smn-gene-treatment-spinal-muscular-atrophy_en.pdf"},
    {"id":"19532","name":"Superseded final overview of comments received on 'Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba' EMEA/HMPC/234113/2006","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T00:09:21Z","last_updated_date":"2014-06-03T01:09:21Z","reference_number":"EMEA/HMPC/489157/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-final-overview-comments-received-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba-emeahmpc2341132006_en.pdf"},
    {"id":"19533","name":"CHMP post-authorisation summary of positive opinion for Tracleer on 26 June 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-06-26T02:00:00Z","last_updated_date":"2008-06-26T02:00:00Z","reference_number":"EMEA/CHMP/210276/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tracleer-26-june-2008_en.pdf"},
    {"id":"19534","name":"Allergen for diagnostic - skin prick test containing only Phleum Pratense (product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010466/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T12:50:00Z","last_updated_date":"2017-07-10T12:50:00Z","reference_number":"EMA/435668/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-diagnostic-skin-prick-test-containing-only-phleum-pratense-product-authorised-mutually-recognition-procedure-list-nationally-authorised-medicinal-products-psusa00010466201610_en.pdf"},
    {"id":"19535","name":"Committee for Advanced Therapies (CAT) monthly report of application procedures, guidelines and related documents on advanced therapies: May 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T14:25:00Z","last_updated_date":"2012-05-30T14:25:00Z","reference_number":"EMA/CAT/337185/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-may-2012-meeting_en.pdf"},
    {"id":"19537","name":"Final briefing book - Qualification of total kidney volume as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-22T11:00:00Z","last_updated_date":"2015-07-22T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/final-briefing-book-qualification-total-kidney-volume-prognostic-biomarker-use-clinical-trials-evaluating-patients-autosomal-dominant-polycystic-kidney-disease-adpkd_en.pdf"},
    {"id":"19538","name":"Public statement on Dynepo: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-04-07T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/126669/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-dynepo-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"19540","name":"Withdrawal assessment report for: Rotigotine Mylan (rotigotine)","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2018-07-11T13:37:00Z","last_updated_date":"2018-07-11T13:37:00Z","reference_number":"EMA/29245/2018","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-rotigotine-mylan-rotigotine_en.pdf"},
    {"id":"19544","name":"Opinion following an Article 31 referral Nimesulide containing medicinal products International Non-Proprietary Name (INN): Nimesulide: Background information and Annexes I,II,IV","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-05-07T02:08:21Z","last_updated_date":"2004-05-07T02:08:21Z","reference_number":"CPMP/1724 /04","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-31-referral-nimesulide-containing-medicinal-products-international-non-proprietary-name-inn-nimesulide-background-information-and-annexes-iiiiv_en.pdf"},
    {"id":"19546","name":"Agenda - European Medicines Agency workshop for micro, small and medium-sized enterprises (SMEs) - Focus on pharmacovigilance","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T11:00:00Z","last_updated_date":"2012-05-03T17:30:00Z","reference_number":"EMA/49479/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-workshop-micro-small-and-medium-sized-enterprises-smes-focus-pharmacovigilance_en.pdf"},
    {"id":"19547","name":"Presentation - HMA/EMA Taskforce on availability of authorised medicines (Brendan Cuddy, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hmaema-taskforce-availability-authorised-medicines-brendan-cuddy-ema_en.pdf"},
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    {"id":"19549","name":"EU/3/14/1365: Public summary of opinion on orphan designation: Recombinant human pentraxin-2 for the treatment of post-polycythaemia vera myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2020-06-08T01:00:00Z","reference_number":"EMA/COMP/660441/2014 Corr.","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141365-public-summary-opinion-orphan-designation-recombinant-human-pentraxin-2-treatment-post-polycythaemia-vera-myelofibrosis_en.pdf"},
    {"id":"19550","name":"Draft Community herbal monograph on Echinacea purpurea (l.) Moench., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:09:21Z","last_updated_date":"2009-07-16T02:09:21Z","reference_number":"EMEA/HMPC/577784/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-echinacea-purpurea-l-moench-radix_en.pdf"},
    {"id":"19553","name":"Overview of comments on 'Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products' (EMA/CAT/80183/2014)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-07-13T02:00:00Z","last_updated_date":"2018-07-13T14:53:00Z","reference_number":"EMA/801611/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-guideline-quality-non-clinical-and-clinical-aspects-gene-therapy-medicinal-products-emacat801832014_en.pdf"},
    {"id":"19555","name":"New treatment for patients with soft tissue sarcoma","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/CHMP/605971/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-treatment-patients-soft-tissue-sarcoma_en.pdf"},
    {"id":"19556","name":"EU/3/04/247: Public summary of positive opinion for orphan designation of 17-allylamino-17-demethoxygeldanamycin for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-03-25T01:00:00Z","reference_number":"EMEA/COMP/143416/2004 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304247-public-summary-positive-opinion-orphan-designation-17-allylamino-17-demethoxygeldanamycin-treatment-multiple-myeloma_en.pdf"},
    {"id":"19558","name":"Presentation - Guidance on transitional measures for the pharmacovigilance legislation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-transitional-measures-pharmacovigilance-legislation_en.pdf"},
    {"id":"19560","name":"Presentation - Qualification of PBPK platform – experience with PK-Sim (Michael Block)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qualification-pbpk-platform-experience-pk-sim-michael-block_en.pdf"},
    {"id":"19561","name":"Lynparza recommended for approval in ovarian cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/648393/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/lynparza-recommended-approval-ovarian-cancer_en.pdf"},
    {"id":"19562","name":"Cefoperazone: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/748/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefoperazone-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19565","name":"Final list of references supporting the assessment of Solanum dulcamara L., stipites","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2013-02-15T01:00:00Z","reference_number":"EMA/HMPC/734362/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-solanum-dulcamara-l-stipites_en.pdf"},
    {"id":"19566","name":"Numeta Article-107i procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-annex-i_en.pdf"},
    {"id":"19568","name":"Loratadine Sandoz 10 - Article 29 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-12-12T00:08:21Z","last_updated_date":"2009-12-12T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/loratadine-sandoz-10-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"19570","name":"Ketorolac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001811/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T12:30:00Z","last_updated_date":"2018-03-09T12:52:34Z","reference_number":"EMA/154217/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketorolac-systemic-formulations-list-nationally-authorised-medicinal-products-psusa00001811201707_en.pdf"},
    {"id":"19571","name":"EU/3/13/1231: Public summary of opinion on orphan designation: (2R,3R,4S,5R)-2-(6-amino-9H-purin-9-yl)-5-((((1r,3S)-3-(2-(5-(tert-butyl)-1H-benzo[d]imidazol-2-yl)ethyl)cyclobutyl)(isopropyl) amino)methyl)tetrahydrofuran-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2014-03-24T01:00:00Z","reference_number":"EMA/COMP/3530/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131231-public-summary-opinion-orphan-designation-2r3r4s5r-2-6-amino-9h-purin-9-yl-5-1r3s-3-2-5-tert-butyl-1h-benzodimidazol-2-ylethylcyclobutylisopropyl-aminomethyltetrahydrofuran_en.pdf"},
    {"id":"19578","name":"Presentation - Summary of product characteristics (SmPC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T13:00:00Z","last_updated_date":"2017-09-06T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summary-product-characteristics-smpc_en.pdf"},
    {"id":"19579","name":"Summary information on a referral opinion following an arbitration according to Article 7(5) of Commission Regulation (EC) No 541/95 as amended, for Zofenil/Zopranol/Bifril International Non-Proprietary Name (INN): zofen...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2000-12-16T00:08:21Z","last_updated_date":"2000-12-16T00:08:21Z","reference_number":"CPMP/2011/00","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-according-article-75-commission-regulation-ec-no-54195-amended-zofenilzopranolbifril-international-non-proprietary-name-inn-zofen_en.pdf"},
    {"id":"19582","name":"Presentation - PRAC interaction with SAWP (Anna Tavridou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prac-interaction-sawp-anna-tavridou_en.pdf"},
    {"id":"19584","name":"Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-23T11:48:01Z","last_updated_date":"2018-07-23T11:48:01Z","reference_number":"CHMP/EWP/18463/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf"},
    {"id":"19585","name":"Guideline on the Core SPC for human plasma derived and recombinant coagulation factor VIII products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-06-29T02:00:00Z","last_updated_date":"2000-06-29T02:00:00Z","reference_number":"CPMP/BPWG/1619/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-plasma-derived-and-recombinant-coagulation-factor-viii-products_en.pdf"},
    {"id":"19586","name":"European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-10-19T14:33:41Z","last_updated_date":"2012-10-19T14:33:41Z","reference_number":"EMA/CHMP/670812/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-first-radiopharmaceutical-pet-imaging-i2-amyloid-neuritic-plaque-density_en.pdf"},
    {"id":"19588","name":"Presentation - Case Study 4 - Challenges in the implementation of model based and PAT based RTRT for a new product","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-4-challenges-implementation-model-based-and-pat-based-rtrt-new-product_en.pdf"},
    {"id":"19589","name":"Download EPS - Species pictograms - Turkey","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-turkey_en.zip"},
    {"id":"19590","name":"Guideline on pharmaceutical fixed combination products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-12-18T01:00:00Z","last_updated_date":"2006-12-18T01:00:00Z","reference_number":"EMEA/CVMP/83804/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-fixed-combination-products_en.pdf"},
    {"id":"19592","name":"Overview of comments received on 'guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use' (EMA/CHMP/BMWP/86289/2010)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:46Z","last_updated_date":"2012-06-15T17:10:46Z","reference_number":"EMA/420188/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use-emachmpbmwp862892010_en.pdf"},
    {"id":"19594","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: September 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T12:00:00Z","last_updated_date":"2016-10-20T12:00:00Z","reference_number":"EMA/536722/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-september-2016_en.pdf"},
    {"id":"19596","name":"EU/3/06/428: Public summary of positive opinion for orphan designation of forodesine hydrochloride for the treatment of cutaneous T cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-13T00:00:00Z","last_updated_date":"2007-12-13T00:00:00Z","reference_number":"EMEA/COMP/465553/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306428-public-summary-positive-opinion-orphan-designation-forodesine-hydrochloride-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"19604","name":"Isotretinoin - Article 29 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/isotretinoin-article-29-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/isotretinoin-article-29-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/isotretinoin-article-29-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/isotretinoin-article-29-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/isotretinoin-article-29-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/isotretinoin-article-29-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/isotretinoin-article-29-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/isotretinoin-article-29-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/isotretinoin-article-29-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/isotretinoin-article-29-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/isotretinoin-article-29-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/isotretinoin-article-29-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/isotretinoin-article-29-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/isotretinoin-article-29-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/isotretinoin-article-29-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/isotretinoin-article-29-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/isotretinoin-article-29-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/isotretinoin-article-29-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/isotretinoin-article-29-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/isotretinoin-article-29-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/isotretinoin-article-29-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/isotretinoin-article-29-referral-annex-iii_sv.pdf"}},
    {"id":"19605","name":"Presentation - Enpr-EMA Coordinating Group: Achievements and challenges","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-26T02:00:00Z","last_updated_date":"2013-06-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-coordinating-group-achievements-and-challenges_en.pdf"},
    {"id":"19606","name":"Withdrawal assessment report for Duloxetine Sandoz","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2015-06-23T02:00:00Z","last_updated_date":"2015-06-23T02:00:00Z","reference_number":"EMA/368328/2015","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-duloxetine-sandoz_en.pdf"},
    {"id":"19607","name":"Working party on Herbal Medicinal Products: Final proposal for a core data for Mentae piperitae aetheroleum","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-03-03T01:00:00Z","last_updated_date":"2004-03-03T01:00:00Z","reference_number":"EMEA/HMPWP/1417/02","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-final-proposal-core-data-mentae-piperitae-aetheroleum_en.pdf"},
    {"id":"19609","name":"Ancillary - Day 180 JAR Non-clinical and clinical template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:25:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-180-jar-non-clinical-and-clinical-template-rev1016_en.doc"},
    {"id":"19612","name":"Presentation - Non-clinical assessment of immunogenicity (Leon van Aerts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-clinical-assessment-immunogenicity-leon-van-aerts_en.pdf"},
    {"id":"19613","name":"Tiludronic acid, disodium salt: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-01-01T01:00:00Z","last_updated_date":"2001-01-01T01:00:00Z","reference_number":"EMEA/MRL/774/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tiludronic-acid-disodium-salt-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19615","name":"EU/03/11/927: Public summary of opinion on orphan designation: Sinapultide, dipalmitoylphosphatidylcholine palmitoyl-oleoyl phosphatidylglycerol, sodium salt and palmitic acid for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2011-11-23T16:00:00Z","reference_number":"EMA/COMP/793892/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu0311927-public-summary-opinion-orphan-designation-sinapultide-dipalmitoylphosphatidylcholine-palmitoyl-oleoyl-phosphatidylglycerol-sodium-salt-and-palmitic-acid-treatment-cystic-fibrosis_en.pdf"},
    {"id":"19618","name":"European Medicines Agency modelling and simulation working group plan 2017","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T09:55:00Z","last_updated_date":"2017-03-09T09:55:00Z","reference_number":"EMA/799154/2016","document_url":"https://www.ema.europa.eu/en/documents/work-programme/european-medicines-agency-modelling-and-simulation-working-group-plan-2017_en.pdf"},
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    {"id":"19624","name":"Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-07-09T16:09:00Z","last_updated_date":"2012-07-09T16:09:00Z","reference_number":"EMA/450864/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/sanofi-aventis-withdraws-its-marketing-authorisation-application-mulsevo-semuloparin-sodium_en.pdf"},
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    {"id":"19641","name":"3.1 Annex II - Statistical analysis of bioequivalence study example data set","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-09T16:00:00Z","last_updated_date":"2016-11-09T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/31-annex-ii-statistical-analysis-bioequivalence-study-example-data-set_en.pdf"},
    {"id":"19644","name":"Diacerein Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2014-01-17T16:45:00Z","reference_number":"EMA/PRAC/747322/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-timetable-procedure_en.pdf"},
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    {"id":"19651","name":"Numeta Article-107i procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-prac-list-questions_en.pdf"},
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    {"id":"19655","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2011 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"EMA/CHMP/571474/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2011-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"19659","name":"Final  European Union herbal monograph on Althaea officinalis L., radix","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T14:59:00Z","last_updated_date":"2016-11-04T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-althaea-officinalis-l-radix_en.pdf"},
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    {"id":"19665","name":"Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-07-17T02:00:00Z","last_updated_date":"2016-10-17T17:35:16Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxyethyl-starch-list-nationally-authorised-medicinal-products-psusa00001694201501_en.pdf"},
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    {"id":"19670","name":"VICH GL7: Efficacy requirements for anthelmintics overall guidelines - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-12-07T01:00:00Z","last_updated_date":"2000-12-07T01:00:00Z","reference_number":"CVMP/VICH/832/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl7-efficacy-requirements-anthelmintics-overall-guidelines-step-7_en.pdf"},
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    {"id":"19678","name":"Withdrawal letter: Revlimid","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T02:00:00Z","last_updated_date":"2012-07-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-revlimid_en.pdf"},
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    {"id":"19685","name":"First stem-cell therapy recommended for approval in EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-19T13:00:00Z","last_updated_date":"2014-12-19T13:00:00Z","reference_number":"EMA/786996/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-stem-cell-therapy-recommended-approval-eu_en.pdf"},
    {"id":"19688","name":"EU/3/04/186: Public summary of positive opinion for orphan designation of treosulfan for the conditioning treatment prior to haematopoietic progenitor cell transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-11-22T00:00:00Z","last_updated_date":"2019-08-30T14:00:00Z","reference_number":"EMEA/COMP/371/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304186-public-summary-positive-opinion-orphan-designation-treosulfan-conditioning-treatment-prior-haematopoietic-progenitor-cell-transplantation_en.pdf"},
    {"id":"19689","name":"Presentation - Modelling and simulation support for design of first-in-man studies: the minimum acceptable biological effect level (MABEL) approach - Break-out session 1 theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:45:00Z","last_updated_date":"2011-11-30T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-support-design-first-man-studies-minimum-acceptable-biological-effect-level-mabel-approach-break-out-session-1-theme-2_en.pdf"},
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    {"id":"19698","name":"Committee for medicinal products for human use, summary of positive opinion for Oprymea","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:00:00Z","last_updated_date":"2008-06-26T02:00:00Z","reference_number":"EMEA/CHMP/313494/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-oprymea_en.pdf"},
    {"id":"19699","name":"CHMP post-authorisation summary of positive opinion for Jentadueto","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T10:38:00Z","last_updated_date":"2016-12-16T10:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jentadueto_en.pdf"},
    {"id":"19701","name":"Triclabendazole: Summary Report (3) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T00:09:21Z","last_updated_date":"1997-11-01T00:09:21Z","reference_number":"EMEA/MRL/196/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/triclabendazole-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"19705","name":"Overview of comments received on \"Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products\"","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-11-28T12:45:00Z","last_updated_date":"2017-11-28T12:45:00Z","reference_number":"EMA/HMPC/183134/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-assessment-clinical-safety-and-efficacy-preparation-european-union-herbal-monographs-well-established-and-traditional-herbal-medicinal-products_en.pdf"},
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    {"id":"19708","name":"Presentation - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting - Transparency – Clinical data release/publication at the EMA (Anne-Sophie He...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-transparency-clinical-data-releasepublication-ema-anne-sophie-he_en.pdf"},
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    {"id":"19711","name":"One year of additional market protection for new indication assessment report template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T15:00:00Z","last_updated_date":"2018-09-18T17:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/one-year-additional-market-protection-new-indication-assessment-report-template_en.docx"},
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    {"id":"19717","name":"EU/3/17/1911: Public summary of opinion on orphan designation: Sodium 2-hydroxylinoleate for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/480448/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171911-public-summary-opinion-orphan-designation-sodium-2-hydroxylinoleate-treatment-pancreatic-cancer_en.pdf"},
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    {"id":"19723","name":"Flupirtine Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMEA/H/A-31/1458","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-timetable-procedure_en.pdf"},
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    {"id":"19726","name":"Agenda - Sixty second meeting of the Management Board, 4 March 2009","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2009-03-04T00:09:21Z","last_updated_date":"2009-03-04T00:09:21Z","reference_number":"EMEA/MB/663707/2008Adopted","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sixty-second-meeting-management-board-4-march-2009_en.pdf"},
    {"id":"19734","name":"Opinion of the CVMP on the establishment of maximum residue limits: Valnemulin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-10-26T19:38:00Z","last_updated_date":"2010-10-26T19:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-valnemulin_en.pdf"},
    {"id":"19735","name":"Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - 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    {"id":"19736","name":"Femara - Article 30 referral - Assessment Report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-06-12T02:00:00Z","last_updated_date":"2012-06-12T02:00:00Z","reference_number":"EMA/267448/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/femara-article-30-referral-assessment-report_en.pdf"},
    {"id":"19738","name":"EU/3/04/199: Public summary of positive opinion for orphan designation of tetrahydrobiopterin for the treatment of hyperphenylalaninemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2011-05-19T01:00:00Z","reference_number":"EMEA/COMP/258/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304199-public-summary-positive-opinion-orphan-designation-tetrahydrobiopterin-treatment-hyperphenylalaninemia_en.pdf"},
    {"id":"19739","name":"CHMP post-authorisation summary of positive opinion for RoActemra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/437831/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-roactemra_en.pdf-0"},
    {"id":"19740","name":"EU/3/17/1950: Public summary of opinion on orphan designation: Adenovirus associated viral vector serotype 8 containing the human AIPL1 gene for the treatment of Leber’s congenital amaurosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-24T10:44:00Z","last_updated_date":"2018-01-24T10:44:00Z","reference_number":"EMA/754024/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171950-public-summary-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-8-containing-human-aipl1-gene-treatment-lebers-congenital-amaurosis_en.pdf"},
    {"id":"19741","name":"Reflection paper on the further involvement of patients and consumers in\n\nthe Agency’s activities","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/MB/753771/2009","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-further-involvement-patients-and-consumers-agencys-activities_en.pdf"},
    {"id":"19742","name":"CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Revised after first teleconference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag1-advice-european-medicines-agency-clinical-trial-advisory-group-protecting-patient-confidentiality-revised-after-first-teleconference_en.pdf"},
    {"id":"19743","name":"CHMP post-authorisation summary of positive opinion for Cimzia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"EMA/CHMP/752205/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cimzia_en.pdf"},
    {"id":"19744","name":"Iron dichloride and iron sulphate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/383/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/iron-dichloride-and-iron-sulphate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19745","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2013 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T16:45:00Z","last_updated_date":"2013-11-26T16:45:00Z","reference_number":"EMA/CAT/574533/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-november-2013-meeting_en.pdf"},
    {"id":"19746","name":"Overview of comments received on ''Draft guideline on the development of new medicinal products for the treatment of Ulcerative Colitis' (EMA/CHMP/EWP/18463/2006 Rev. 1)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T11:48:00Z","last_updated_date":"2018-07-23T11:48:00Z","reference_number":"EMA/CHMP/354664/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-development-new-medicinal-products-treatment-ulcerative-colitis-emachmpewp184632006-rev-1_en.pdf"},
    {"id":"19748","name":"Letter from Health Canada to the European Medicines Agency and the European Commission: Confidentiality agreement details","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-15T16:30:00Z","last_updated_date":"2013-03-15T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-health-canada-european-medicines-agency-and-european-commission-confidentiality-agreement-details_en.pdf"},
    {"id":"19749","name":"Gadobutrol: List of nationally authorised medicinal products - PSUSA/00001502/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T01:00:00Z","last_updated_date":"2016-10-19T12:37:29Z","reference_number":"EMA/PRAC/4354/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadobutrol-list-nationally-authorised-medicinal-products-psusa00001502201504_en.pdf"},
    {"id":"19750","name":"Presentation - One Health: coordinating prudent use of antimicrobials in human and veterinary medicine (David Mackay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-one-health-coordinating-prudent-use-antimicrobials-human-and-veterinary-medicine-david-mackay_en.pdf"},
    {"id":"19751","name":"9th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-01-18T00:00:00Z","last_updated_date":"2001-01-18T00:00:00Z","reference_number":"COMP/16/01 corr.","document_url":"https://www.ema.europa.eu/en/documents/press-release/9th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"19752","name":"Presentation - Session 4.2: Global collaboration between regulatory agencies with paediatric research networks (Irmgard Eichler, Susan McCune)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-42-global-collaboration-between-regulatory-agencies-paediatric-research-networks-irmgard-eichler-susan-mccune_en.pdf"},
    {"id":"19753","name":"Reflection paper on working parties: Committee for Medicinal Products for Human Use/European Medicines Agency group analysis and proposals","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-10-25T14:13:14Z","last_updated_date":"2010-10-25T14:13:14Z","reference_number":"EMA/315270/2010","document_url":"https://www.ema.europa.eu/en/documents/report/reflection-paper-working-parties-committee-medicinal-products-human-useeuropean-medicines-agency-group-analysis-and-proposals_en.pdf"},
    {"id":"19754","name":"Superseded opinion of the HMPC on a community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-02-28T16:15:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/888910/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-revision-1_en.pdf"},
    {"id":"19755","name":"Hearing with the Association of the European Self-Medication Industry (AESGP) during the April 2016 Working Party on Community Monographs and Community List meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-06-10T02:00:00Z","last_updated_date":"2016-06-10T02:00:00Z","reference_number":"EMA/HMPC/313623/2016","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-aesgp-during-april-2016-working-party-community-monographs-and-community-list-meeting_en.pdf"},
    {"id":"19756","name":"Committee for Proprietary Medicinal Products (CPMP) 66th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-12-18T01:00:00Z","last_updated_date":"2000-12-18T01:00:00Z","reference_number":"CPMP/4305/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-66th-plenary-meeting_en.pdf"},
    {"id":"19758","name":"Presentation - Additional monitoring of medicines and side-effect reporting – impact on the product information","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-additional-monitoring-medicines-and-side-effect-reporting-impact-product-information_en.pdf"},
    {"id":"19759","name":"Presentation - EMA Patients and Consumers’ Annual Training Overview: 2007-2016 (M.Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T02:00:00Z","last_updated_date":"2017-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-patients-and-consumers-annual-training-overview-2007-2016-mmavris-ema_en.pdf"},
    {"id":"19760","name":"Call for submission of scientific data relating to the assessment of  Matricariae aetheroleum; Matricaria recutita L. (Chamomilla recutita L. Rauschert), aetheroleum (Matricaria oil) - First version","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-08-15T02:00:00Z","last_updated_date":"2009-08-15T02:00:00Z","reference_number":"EMEA/HMPC/468687/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-matricariae-aetheroleum-matricaria-recutita-l-chamomilla-recutita-l-rauschert-aetheroleum-matricaria-oil-first-version_en.pdf"},
    {"id":"19761","name":"EU/3/15/1547: Public summary of opinion on orphan designation: Mazindol for the treatment of narcolepsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-16T01:00:00Z","last_updated_date":"2015-11-16T01:00:00Z","reference_number":"EMA/COMP/623175/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151547-public-summary-opinion-orphan-designation-mazindol-treatment-narcolepsy_en.pdf"},
    {"id":"19762","name":"Gamithromycin (Bovine species): European Public MRL Assessment Report (EPMAR) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/CVMP/567075/2008","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gamithromycin-bovine-species-european-public-mrl-assessment-report-epmar-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19763","name":"New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T01:00:00Z","last_updated_date":"2015-03-27T01:00:00Z","reference_number":"EMA/149624/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-restrictions-minimise-risks-effects-heart-rhythm-hydroxyzine-containing-medicines_en.pdf"},
    {"id":"19764","name":"Presentation - Session 1: Definition of a driver. Cellular/tissular mechanisms supporting that a driver becomes a target multiple drivers, mechanisms of resistance (Christian Rolfo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-definition-driver-cellulartissular-mechanisms-supporting-driver-becomes-target-multiple-drivers-mechanisms-resistance-christian-rolfo_en.pdf"},
    {"id":"19767","name":"Nomination form for European experts","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-27T00:09:21Z","last_updated_date":"2014-12-05T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/nomination-form-european-experts_en.pdf"},
    {"id":"19770","name":"Presentation - New Variations Regulation – “Quality Related Changes”","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-variations-regulation-quality-related-changes_en.pdf"},
    {"id":"19772","name":"EU/3/10/787: Public summary of opinion on orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt for the treatment of mantle-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"EMA/COMP/476246/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310787-public-summary-opinion-orphan-designation-3s-3-4-7-aminocarbonyl-2h-indazol-2-yl-phenyl-piperidine-tosylate-monohydrate-salt-treatment-mantle-cell-lymphoma_en.pdf"},
    {"id":"19774","name":"Agenda - Sixty-forth meeting of the Management Board, 1 October 2009","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2009-10-01T02:09:21Z","last_updated_date":"2009-10-01T02:09:21Z","reference_number":"EMEA/MB/358420/2009Adopted","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sixty-forth-meeting-management-board-1-october-2009_en.pdf"},
    {"id":"19775","name":"Opinion following an Article 34 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names: Background 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    {"id":"19847","name":"Agenda - Workshop on haemophilia registries","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-04-30T15:00:02Z","last_updated_date":"2015-06-25T11:30:00Z","reference_number":"EMA/CHMP/BPWP/190322/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-haemophilia-registries_en.pdf"},
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    {"id":"19877","name":"European Medicines Agency’s Management Board nominates Guido Rasi as new Executive Director","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-08T19:41:48Z","last_updated_date":"2011-06-10T19:41:48Z","reference_number":"EMA/348365/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-nominates-guido-rasi-new-executive-director_en.pdf"},
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    {"id":"19882","name":"EU/3/16/1711: Public summary of opinion on orphan designation : Volanesorsen sodium for the treatment of familial partial lipodystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-05T02:00:00Z","last_updated_date":"2016-09-05T02:00:00Z","reference_number":"EMA/COMP/444302/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161711-public-summary-opinion-orphan-designation-volanesorsen-sodium-treatment-familial-partial-lipodystrophy_en.pdf"},
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    {"id":"19889","name":"Final assessment report on Sisymbrium officinale (L.) Scop., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-10-30T01:00:00Z","last_updated_date":"2014-10-30T01:00:00Z","reference_number":"EMA/HMPC/280194/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"19890","name":"First experiences with the PRAC","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-10-10T14:00:00Z","last_updated_date":"2012-10-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/first-experiences-prac_en.pdf"},
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    {"id":"19894","name":"Policy on combined Summaries of Product Characteristics (SmPCs)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-06-10T17:00:00Z","last_updated_date":"2015-06-10T17:00:00Z","reference_number":"EMA/333423/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/policy-combined-summaries-product-characteristics-smpcs_en.pdf"},
    {"id":"19897","name":"CHMP summary of positive opinion for Glybera","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-07-20T02:00:00Z","last_updated_date":"2012-07-20T02:00:00Z","reference_number":"EMA/CHMP/472167/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-glybera_en.pdf"},
    {"id":"19898","name":"Report on EudraVigilance implementation: Veterinary medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-03-05T00:09:21Z","last_updated_date":"2009-03-05T00:09:21Z","reference_number":"EMEA/86607/2009","document_url":"https://www.ema.europa.eu/en/documents/report/report-eudravigilance-implementation-veterinary-medicines_en.pdf"},
    {"id":"19900","name":"Final list of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:30:00Z","last_updated_date":"2016-04-27T12:30:00Z","reference_number":"EMA/HMPC/150847/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-valeriana-officinalis-l-radix-and-valeriana-officinalis-l-aetheroleum_en.pdf"},
    {"id":"19902","name":"Presentation - PIP session: Current clinical and research picture in paediatric anterior segment disorders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pip-session-current-clinical-and-research-picture-paediatric-anterior-segment-disorders_en.pdf"},
    {"id":"19904","name":"n-Butanol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-01-01T01:00:00Z","last_updated_date":"1997-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/n-butanol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19906","name":"EU-RMP Annex I form for 64 bit operating system  - Electronic interface for EudraVigilance (Version 5.1 – October 2013)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-07-07T02:00:00Z","reference_number":"Version 5.1 – October 2013","document_url":"https://www.ema.europa.eu/en/documents/other/eu-rmp-annex-i-form-64-bit-operating-system-electronic-interface-eudravigilance-version-51-october-2013_en.zip"},
    {"id":"19910","name":"Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"CHMP/EWP/89249/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-pharmacokinetics-therapeutic-proteins_en.pdf"},
    {"id":"19913","name":"Withdrawal assessment report for Tyvaso","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-05-17T02:00:00Z","last_updated_date":"2010-05-17T02:00:00Z","reference_number":"EMEA/CHMP/739698/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tyvaso_en.pdf"},
    {"id":"19920","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-09-13T02:00:00Z","last_updated_date":"2013-09-13T02:00:00Z","reference_number":"EMA/CVMP/494034/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-september-2013_en.pdf"},
    {"id":"19921","name":"CVMP post-authorisation summary of positive opinion for Loxicom","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-05-06T02:00:00Z","last_updated_date":"2011-05-06T02:00:00Z","reference_number":"EMA/CVMP/62249/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-loxicom_en.pdf-2"},
    {"id":"19922","name":"Work instructions for publication of web content on www.ema.europa.eu","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-03-18T01:00:00Z","last_updated_date":"2016-07-07T19:00:00Z","reference_number":"WIN/EMA/0099","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-publication-web-content-wwwemaeuropaeu_en.pdf"},
    {"id":"19927","name":"Presentation - Development of drugs for acute otitis media and acute bacterial sinusitis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:46Z","last_updated_date":"2011-04-26T18:05:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-acute-otitis-media-and-acute-bacterial-sinusitis_en.pdf"},
    {"id":"19931","name":"Guideline on compassionate use of medicinal products, pursuant to Article 83 of Regulation (EC) No 726/2004","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/27170/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-compassionate-use-medicinal-products-pursuant-article-83-regulation-ec-no-7262004_en.pdf"},
    {"id":"19933","name":"Work programme for the European Agency for the Evaluation of Medicinal Products 1997-1998","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"1997-02-11T00:09:21Z","last_updated_date":"1997-02-11T00:09:21Z","reference_number":"EMEA/MB/002/97.final","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1997-1998_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1997-1998_es.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1997-1998_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1997-1998_fr.pdf"}},
    {"id":"19934","name":"Presentation - Drug development for behavioral and psychological symptoms of dementia in Japan (Akifumi Kamata)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-drug-development-behavioral-and-psychological-symptoms-dementia-japan-akifumi-kamata_en.pdf"},
    {"id":"19936","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-15T17:00:00Z","last_updated_date":"2016-07-15T17:00:00Z","reference_number":"EMA/CVMP/454098/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-july-2016_en.pdf"},
    {"id":"19937","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 23 to 25 April 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-04-28T02:00:00Z","last_updated_date":"2003-04-28T02:00:00Z","reference_number":"EMEA/CPMP/2376/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-23-25-april-2003_en.pdf"},
    {"id":"19938","name":"Presentation - Stockouts in Europe 2011 (David H.-U. Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T17:00:00Z","last_updated_date":"2013-07-18T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stockouts-europe-2011-david-h-u-haerry_en.pdf"},
    {"id":"19940","name":"Final assessment report on Primula veris L. and / or Primula elatior (L.) Hill, radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T01:00:00Z","last_updated_date":"2013-03-04T01:00:00Z","reference_number":"EMA/HMPC/113577/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-primula-veris-l-and-or-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"19941","name":"Presentation - Topic 1 - Identification of paediatric medical needs – methodology - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-1-identification-paediatric-medical-needs-methodology-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation_en.pdf"},
    {"id":"19942","name":"Presentation - Assessment challenges in the non-clinical development of CAR and TCR modified effector cells (Bjà¶rn Carlsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-assessment-challenges-non-clinical-development-car-and-tcr-modified-effector-cells-bjaprn-carlsson_en.pdf"},
    {"id":"19943","name":"EU/3/06/407: Public summary of positive opinion for orphan designation of heparin-binding epidermal growth factor-like growth factor (HB-EGF), amino acids 74-148 for the prevention of necrotizing enterocolitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2014-01-13T01:00:00Z","reference_number":"EMEA/COMP/183997/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306407-public-summary-positive-opinion-orphan-designation-heparin-binding-epidermal-growth-factor-growth-factor-hb-egf-amino-acids-74-148-prevention-necrotizing-enterocolitis_en.pdf"},
    {"id":"19944","name":"EU/3/13/1229: Public summary of opinion on orphan designation: Autologous dendritic cells pulsed with allogeneic tumour cell lysate for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/COMP/17038/2014 REv. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131229-public-summary-opinion-orphan-designation-autologous-dendritic-cells-pulsed-allogeneic-tumour-cell-lysate-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"19947","name":"Public summary of negative opinion for orphan designation: 3-(3-Methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride for the treatment of narcolepsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/751496/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-3-3-methanesulfonyl-phenyl-1-propyl-piperidine-hydrochloride-treatment-narcolepsy_en.pdf"},
    {"id":"19949","name":"PDCO meeting highlights 12-14 November 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-11-26T00:00:00Z","last_updated_date":"2008-11-26T00:00:00Z","reference_number":"EMEA/610751/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-12-14-november-2008_en.pdf"},
    {"id":"19951","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Recombinant human heparan N-sulfatase (rhHNS) for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo syndrome type A)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/779395/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-recombinant-human-heparan-n-sulfatase-rhhns-treatment-mucopolysaccharidosis-type-iiia-sanfilippo-syndrome-type_en.pdf"},
    {"id":"19953","name":"Countries should reduce use of colistin in animals to decrease the risk of antimicrobial resistance","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-27T13:00:00Z","last_updated_date":"2016-07-27T13:00:00Z","reference_number":"EMA/480583/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/countries-should-reduce-use-colistin-animals-decrease-risk-antimicrobial-resistance_en.pdf"},
    {"id":"19954","name":"Presentation - Communication and dissemination of European Medicines Agency information: perspective from healthcare professionals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-and-dissemination-european-medicines-agency-information-perspective-healthcare-professionals_en.pdf"},
    {"id":"19955","name":"Allantoin: Summary Report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-10-01T02:00:00Z","last_updated_date":"2001-10-01T02:00:00Z","reference_number":"EMEA/MRL/804/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/allantoin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"19956","name":"Presentation - Patient-reported outcomes, biomarkers and\n\nnovel methodologies, and their role in the\n\ndevelopment of new multiple sclerosis medicines (Frank Dahlke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-reported-outcomes-biomarkers-and-novel-methodologies-and-their-role-development-new-multiple-sclerosis-medicines-frank-dahlke_en.pdf"},
    {"id":"19962","name":"Overview of comments received on reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-28T13:12:00Z","last_updated_date":"2013-11-28T13:12:00Z","reference_number":"EMA/682105/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-data-requirements-intravenous-liposomal-products-developed-reference-innovator-liposomal-product_en.pdf"},
    {"id":"19964","name":"Agenda - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / substance, product, organisation and referential data (SPOR) task force meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T17:00:00Z","last_updated_date":"2017-12-20T17:00:00Z","reference_number":"EMA/647593/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf"},
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    {"id":"19970","name":"Rosuvastatin: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002664/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-31T11:27:00Z","last_updated_date":"2018-08-31T11:36:38Z","reference_number":"PSUSA/00002664/201711","document_url":"https://www.ema.europa.eu/en/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_sv.pdf","is":"https://www.ema.europa.eu/is/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_is.pdf","no":"https://www.ema.europa.eu/no/documents/psusa/rosuvastatin-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-psusa00002664201711_no.pdf"}},
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    {"id":"20128","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Reslizumab for treatment of asthma","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/112434/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-reslizumab-treatment-asthma_en.pdf"},
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    {"id":"20139","name":"Presentation - European Patients' Academy on Therapeutic Innovation(EUPATI): preparing guidance for interaction Interactive session at DIA Europe 2015 (David Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-10T18:30:00Z","last_updated_date":"2015-08-10T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-patients-academy-therapeutic-innovationeupati-preparing-guidance-interaction-interactive-session-dia-europe-2015-david-haerry_en.pdf"},
    {"id":"20141","name":"Agenda second workshop on European Paediatric Network (EnprEMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"EMA/337008/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-workshop-european-paediatric-network-enprema_en.pdf"},
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    {"id":"20144","name":"Concept paper on the need for the development of a paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/EWP/545456/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-development-paediatric-addendum-note-guidance-clinical-investigation-medicinal-products-treatment-hypertension_en.pdf"},
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    {"id":"20190","name":"Committee for Proprietary Medicinal Products (CPMP) 42nd plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-10-26T00:00:00Z","last_updated_date":"1998-10-26T00:00:00Z","reference_number":"CPMP/2244/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-42nd-plenary-meeting_en.pdf"},
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    {"id":"20363","name":"Presentation - Neuromyelitis optica: Is there a standard of care? (Eliezer Katz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-neuromyelitis-optica-there-standard-care-eliezer-katz_en.pdf"},
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    {"id":"20384","name":"Final list of references supporting the assessment of Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/HMPC/36892/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus_en.pdf"},
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    {"id":"20402","name":"Hydroxyzine Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T17:00:00Z","last_updated_date":"2014-05-08T17:00:00Z","reference_number":"EMA/268604/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-review-started_en.pdf"},
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    {"id":"20406","name":"Overview of comments received on structure of the list of herbal substances, preparations and combinations thereof (EMEA/HMPC/100824/2005)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-10-24T02:09:21Z","last_updated_date":"2005-10-24T02:09:21Z","reference_number":"EMEA/HMPC/309366/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-structure-list-herbal-substances-preparations-and-combinations-thereof-emeahmpc1008242005_en.pdf"},
    {"id":"20407","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous Wharton’s jelly derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/462485/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-autologous-whartons-jelly-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"20408","name":"Elemental impurities in marketed products. Recommendations for implementation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T17:10:00Z","last_updated_date":"2015-03-27T17:10:00Z","reference_number":"EMA/CHMP/QWP/109127/2015","document_url":"https://www.ema.europa.eu/en/documents/other/elemental-impurities-marketed-products-recommendations-implementation_en.pdf"},
    {"id":"20410","name":"Lauri folii aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/564/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lauri-folii-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20411","name":"Overview of comments received on Community herbal monograph on Taraxacum officinale Weber ex Wigg., radix cum herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/HMPC/400536/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf"},
    {"id":"20413","name":"Factor VIII Article-31 referral - No clear and consistent evidence of difference in risk of inhibitor development between classes","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-12-05T01:00:00Z","reference_number":"EMA/603417/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-no-clear-and-consistent-evidence-difference-risk-inhibitor-development-between-classes_en.pdf"},
    {"id":"20414","name":"Presentation - \n\nApproaches to the non-clinical development of advanced therapy medicinal products (Fernando Mà©ndez-Hermida)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T18:12:00Z","last_updated_date":"2016-10-26T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-approaches-non-clinical-development-advanced-therapy-medicinal-products-fernando-macndez-hermida_en.pdf"},
    {"id":"20416","name":"C(2002) 2822: Public summary of negative opinion for orphan designation of chlorproguanil hydrochloride and dapsone for the treatment of acute uncomplicated Plasmodium falciparum malaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-08T00:00:00Z","last_updated_date":"2003-01-08T00:00:00Z","reference_number":"EMEA/COMP/1073/02 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/c2002-2822-public-summary-negative-opinion-orphan-designation-chlorproguanil-hydrochloride-and-dapsone-treatment-acute-uncomplicated-plasmodium-falciparum-malaria_en.pdf"},
    {"id":"20419","name":"Presentation - How researchers contribute to measuring impact? (Agnes Kant)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-researchers-contribute-measuring-impact-agnes-kant_en.pdf"},
    {"id":"20420","name":"Ambroxol and bromhexine Article-31 referral - PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-12T13:00:00Z","last_updated_date":"2015-01-12T13:00:00Z","reference_number":"EMA/796499/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-prac-considers-risk-severe-allergic-reactions-ambroxol-and-bromhexine-containing-medicines-be-small_en.pdf"},
    {"id":"20421","name":"Confidentiality arrangements concluded between the European Union (European Commission and European Medicines Agency) and the United States Food and Drug Administration / Department of Health and Human Services - Impleme...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-05-22T02:09:21Z","last_updated_date":"2008-05-22T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/confidentiality-arrangements-concluded-between-european-union-european-commission-and-european-medicines-agency-and-united-states-food-and-drug-administration-department-health-and-human-services_en.pdf-1"},
    {"id":"20422","name":"Presentation - Modelling and simulation as a tool to bridge pharmacokinetics, efficacy and safety data in special populations, ethnic groups and rare diseases - Break-out session 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-tool-bridge-pharmacokinetics-efficacy-and-safety-data-special-populations-ethnic-groups-and-rare-diseases-break-out-session-3_en.pdf"},
    {"id":"20423","name":"CHMP summary of positive opinion for Arepanrix","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-01-22T01:00:00Z","last_updated_date":"2010-01-22T01:00:00Z","reference_number":"EMA/CHMP/30965/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-arepanrix_en.pdf"},
    {"id":"20424","name":"Bacterial lysate medicines Article 31 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2018-07-04T16:12:00Z","last_updated_date":"2019-09-16T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bacterial-lysate-medicines-article-31-referral-annex-i_sv.pdf"}},
    {"id":"20425","name":"Joint opinion on antimicrobial resistance focused on zoonotic infections","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-11-16T00:09:21Z","last_updated_date":"2009-11-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joint-opinion-antimicrobial-resistance-focused-zoonotic-infections_en.pdf"},
    {"id":"20426","name":"Questions and answers on EMLA cream and associated names (lidocaine 25 mg/g and prilocaine 25 mg/g; cream for topical use)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"EMA/440595/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-emla-cream-and-associated-names-lidocaine-25-mgg-and-prilocaine-25-mgg-cream-topical-use_sv.pdf"}},
    {"id":"20430","name":"Day 80 assessment report generics quality guidance rev.10.16","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2016-11-08T12:00:00Z","reference_number":"Rev. 3.16","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-generics-quality-guidance-rev1016_en.pdf"},
    {"id":"20431","name":"Flupirtine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-05-04T02:00:00Z","last_updated_date":"2018-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flupirtine-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flupirtine-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flupirtine-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flupirtine-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flupirtine-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flupirtine-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flupirtine-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flupirtine-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/flupirtine-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flupirtine-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flupirtine-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flupirtine-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flupirtine-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flupirtine-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flupirtine-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flupirtine-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flupirtine-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flupirtine-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flupirtine-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flupirtine-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flupirtine-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flupirtine-article-31-referral-annex-i_sv.pdf"}},
    {"id":"20434","name":"Withdrawal assessment report for Ibandronic acid Hexal","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-10-21T14:15:00Z","last_updated_date":"2011-10-21T14:15:00Z","reference_number":"EMEA/H/C/000859","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ibandronic-acid-hexal_en.pdf-0"},
    {"id":"20439","name":"Final European Union herbal monograph on Eschscholzia californica Cham., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/HMPC/680372/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-eschscholzia-californica-cham-herba_en.pdf"},
    {"id":"20442","name":"Statement  on British Biotech Pharmaceuticals Ltd.'s ZACUTEX Application of the 5th May 1998","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-05-05T02:00:00Z","last_updated_date":"1998-05-05T02:00:00Z","reference_number":"EMEA/18846/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/statement-british-biotech-pharmaceuticals-ltds-zacutex-application-5th-may-1998_en.pdf"},
    {"id":"20443","name":"Agenda and registration form - The new EudraVigilance system and electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Paris","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T14:30:00Z","last_updated_date":"2017-09-26T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-paris_en.pdf-0"},
    {"id":"20444","name":"CHMP summary of positive opinion for Repatha","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/291871/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-repatha_en.pdf"},
    {"id":"20445","name":"CVMP summary of positive opinion for ProZinc","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-05-17T17:00:00Z","last_updated_date":"2013-05-17T17:00:00Z","reference_number":"EMA/CVMP/250455/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-prozinc_en.pdf"},
    {"id":"20448","name":"PDCO meeting highlights 9-11 April 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-04-15T02:00:00Z","last_updated_date":"2008-04-15T02:00:00Z","reference_number":"EMEA/PDCO/190452/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-9-11-april-2008_en.pdf"},
    {"id":"20451","name":"Draft European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2016-11-07T17:01:00Z","last_updated_date":"2016-11-07T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-silybum-marianum-l-gaertn-fructus_en.pdf"},
    {"id":"20452","name":"EU/3/14/1404: Public summary of opinion on orphan designation: 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one for the treatment of multiple system atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/COMP/722694/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141404-public-summary-opinion-orphan-designation-1-2-isopropoxyethyl-2-thioxo-1235-tetrahydro-pyrrolo32-d-pyrimidin-4-one-treatment-multiple-system-atrophy_en.pdf"},
    {"id":"20454","name":"Lini oleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-09-01T02:00:00Z","last_updated_date":"1997-09-01T02:00:00Z","reference_number":"EMEA/MRL/263/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lini-oleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"20470","name":"Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-11T17:27:00Z","last_updated_date":"2018-09-11T17:29:46Z","reference_number":"EMA/612663/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/acebutolol-list-nationally-authorised-medicinal-products-psusa00000018201712_en.pdf"},
    {"id":"20472","name":"Committee for veterinary medicinal products: 40th meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1999-02-18T12:09:21Z","last_updated_date":"1999-02-18T12:09:21Z","reference_number":"EMEA/CVMP/079/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-40th-meeting_en.pdf"},
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    {"id":"20475","name":"EU/3/15/1431: Public summary of opinion on orphan designation: 3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid for the treatment of hereditary a...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-08T02:00:00Z","last_updated_date":"2017-04-25T02:00:00Z","reference_number":"EMA/COMP/48508/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151431-public-summary-opinion-orphan-designation-3-2-4-carbamimidoyl-phenylcarbamoyl-5-methoxy-4-vinyl-phenyl-6-cyclopropylmethyl-carbamoyl-pyridine-2-carboxylic-acid-treatment-hereditary_en.pdf"},
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    {"id":"20487","name":"EU/3/13/1159: Public summary of opinion on orphan designation: Idelalisib for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T17:30:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/COMP/400936/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131159-public-summary-opinion-orphan-designation-idelalisib-treatment-follicular-lymphoma_en.pdf"},
    {"id":"20488","name":"Retinoid Article-31 referral - PRAC assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"EMA/254364/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"20490","name":"EU/3/09/637: Public summary of positive opinion for orphan designation\n\nof 2',3',5'-tri-O-acetyluridine for the treatment of 5-fluorouracil overdose","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-09T02:09:21Z","last_updated_date":"2009-06-09T02:09:21Z","reference_number":"EMEA/COMP/231352/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309637-public-summary-positive-opinion-orphan-designation-235-tri-o-acetyluridine-treatment-5-fluorouracil-overdose_en.pdf"},
    {"id":"20491","name":"EU/3/12/1025: Public summary of opinion on orphan designation: Metreleptin for the treatment of Berardinelli-Seip syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-08-31T12:30:00Z","last_updated_date":"2015-05-13T12:30:00Z","reference_number":"EMA/COMP/440572/2012 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121025-public-summary-opinion-orphan-designation-metreleptin-treatment-berardinelli-seip-syndrome_en.pdf"},
    {"id":"20494","name":"Comments received from public consultation on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-12T12:30:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/647795/2017","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-module-ix-addendum-i-methodological-aspects-signal-detection-spontaneous-reports-suspected-adverse-reactions_en.pdf"},
    {"id":"20495","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the May 2008 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-05-19T02:09:21Z","last_updated_date":"2008-05-19T02:09:21Z","reference_number":"EMEA/COMP/260441/08","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-may-2008-meeting_en.pdf"},
    {"id":"20497","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 23-24 January 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-02-14T11:00:00Z","last_updated_date":"2012-02-14T11:00:00Z","reference_number":"EMA/HMPC/78352/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-23-24-january-2012_en.pdf"},
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    {"id":"20541","name":"Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-12-10T01:00:00Z","reference_number":"EMA/562334/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-didanosine-and-associated-names-didanosine-gastro-resistant-capsules-200-250-and-400-mg_sv.pdf"}},
    {"id":"20542","name":"Committee for Proprietary Medicinal Products (CPMP) 59th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-04-17T02:00:00Z","last_updated_date":"2000-04-17T02:00:00Z","reference_number":"CPMP/941/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-59th-plenary-meeting_en.pdf"},
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    {"id":"20550","name":"Presentation - Veterinary experience with scientific and regulatory advice, Dr. Karen Quigley","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-experience-scientific-and-regulatory-advice-dr-karen-quigley_en.pdf"},
    {"id":"20551","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products -Meeting of 17 and 18 December 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-12-19T01:00:00Z","last_updated_date":"2002-12-19T01:00:00Z","reference_number":"EMEA/CPMP/6589/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-17-and-18-december-2002_en.pdf"},
    {"id":"20552","name":"Questions and answers relating to open procedure – European Medicines Agency 2012-37-ED Online Strategy and Interface Design","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T19:30:00Z","last_updated_date":"2013-07-11T19:30:00Z","reference_number":"EMA/352562/2013","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-open-procedure-european-medicines-agency-2012-37-ed-online-strategy-and-interface-design_en.pdf-0"},
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    {"id":"20624","name":"Tibolona-Article 29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-08T02:00:00Z","last_updated_date":"2014-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tibolona-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tibolona-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tibolona-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tibolona-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tibolona-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tibolona-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tibolona-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tibolona-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tibolona-article-294-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/tibolona-article-294-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tibolona-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tibolona-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tibolona-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tibolona-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tibolona-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tibolona-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tibolona-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tibolona-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tibolona-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tibolona-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tibolona-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tibolona-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tibolona-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"20625","name":"Presentation - Novel methodologies for clinical trials - do we still need to recruit patients? Mr Hemmings","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-novel-methodologies-clinical-trials-do-we-still-need-recruit-patients-mr-hemmings_en.pdf"},
    {"id":"20627","name":"CHMP post-authorisation summary of positive opinion for Gazyvaro (II-16)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T13:03:00Z","last_updated_date":"2017-07-21T13:03:00Z","reference_number":"EMA/CHMP/296989/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-gazyvaro-ii-16_en.pdf"},
    {"id":"20628","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - June 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-06-30T02:00:00Z","last_updated_date":"2005-06-30T02:00:00Z","reference_number":"EMEA/212345/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-june-2005_en.pdf"},
    {"id":"20630","name":"CHMP post-authorisation summary of positive opinion for Jentadueto","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/CHMP/798869/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jentadueto_en.pdf-0"},
    {"id":"20631","name":"Public summary of opinion on orphan designation: Molgramostim for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-05T02:00:00Z","last_updated_date":"2010-08-05T02:00:00Z","reference_number":"EMA/COMP/327903/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-molgramostim-treatment-cystic-fibrosis_en.pdf"},
    {"id":"20634","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Hannes Wahlroos","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-hannes-wahlroos_en.pdf"},
    {"id":"20636","name":"EU/3/14/1412: Public summary of opinion on orphan designation: Herpes simplex type 1 virus containing cellular B-myb gene as tumour-specific promoter for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/COMP/797466/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141412-public-summary-opinion-orphan-designation-herpes-simplex-type-1-virus-containing-cellular-b-myb-gene-tumour-specific-promoter-treatment-pancreatic-cancer_en.pdf"},
    {"id":"20638","name":"Public statement on Quintanrix: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-08-29T02:00:00Z","last_updated_date":"2008-08-29T02:00:00Z","reference_number":"EMEA/424484/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-quintanrix-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"20639","name":"Withdrawal assessment report for Ellefore","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-05-13T02:00:00Z","last_updated_date":"2009-05-13T02:00:00Z","reference_number":"EMEA/45054/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ellefore_en.pdf"},
    {"id":"20640","name":"Presentation - Perspective of veterinary SMEs on challenges meeting the requirements for authorisation of vaccines in the European Union (Rhona Banks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-perspective-veterinary-smes-challenges-meeting-requirements-authorisation-vaccines-european-union-rhona-banks_en.pdf"},
    {"id":"20644","name":"European Commission, EMEA and FDA agree on guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-05-31T02:00:00Z","last_updated_date":"2009-05-31T02:00:00Z","reference_number":"EMEA/191367/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/european-commission-emea-and-fda-agree-guiding-principles-joint-fda-emea-voluntary-genomic-data-submission-briefing-meetings_en.pdf"},
    {"id":"20645","name":"Presentation - Research plan for the International Neonatal Consortium: specimen topic (Jon Davis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-research-plan-international-neonatal-consortium-specimen-topic-jon-davis_en.pdf"},
    {"id":"20648","name":"Presentation - Minor-use-minor-species (MUMS) policy: An update (Kornelia Grein)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-minor-use-minor-species-mums-policy-update-kornelia-grein_en.pdf"},
    {"id":"20649","name":"EU/3/18/2029: Public summary of opinion on orphan designation: 2-[(2S)-2-methyl-1,4-dioxa-8-azaspiro[4.5]dec-8-yl]-8-nitro-6-trifluoromethyl-4H-1,3-benzothiazin-4-one for the treatment of tuberculosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T12:43:00Z","last_updated_date":"2018-08-21T12:43:00Z","reference_number":"EMA/395070/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182029-public-summary-opinion-orphan-designation-2-2s-2-methyl-14-dioxa-8-azaspiro45dec-8-yl-8-nitro-6-trifluoromethyl-4h-13-benzothiazin-4-one-treatment-tuberculosis_en.pdf"},
    {"id":"20650","name":"EMEA recommends strengthening warnings and contraindications for etoricoxib-containing medicines used in the treatment of rheumatoid arthritis and ankylosing spondylitis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2008-06-26T02:09:21Z","reference_number":"EMEA/CHMP/333636/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-strengthening-warnings-and-contraindications-etoricoxib-containing-medicines-used-treatment-rheumatoid-arthritis-and-ankylosing-spondylitis_en.pdf"},
    {"id":"20652","name":"Presentation - EudraVigilance change management planning: latest updates, new webpage and training support (Francois Domergue)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T16:15:00Z","last_updated_date":"2016-08-15T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-change-management-planning-latest-updates-new-webpage-and-training-support-francois-domergue_en.pdf"},
    {"id":"20653","name":"CHMP post-authorisation summary of positive opinion for Enbrel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/408365/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-enbrel_en.pdf-2"},
    {"id":"20655","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 13-16 September 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-09-16T02:00:00Z","last_updated_date":"2004-09-16T02:00:00Z","reference_number":"EMEA/74329/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-13-16-september-2004_en.pdf"},
    {"id":"20656","name":"Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-13T13:00:00Z","last_updated_date":"2018-09-13T13:42:55Z","reference_number":"EMA/475638/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/propofol-list-nationally-authorised-medicinal-products-psusa00002555201711_en.pdf"},
    {"id":"20659","name":"Buflomedil - Article 107 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-13T02:00:00Z","last_updated_date":"2012-06-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/buflomedil-article-107-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/buflomedil-article-107-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/buflomedil-article-107-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/buflomedil-article-107-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/buflomedil-article-107-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/buflomedil-article-107-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/buflomedil-article-107-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/buflomedil-article-107-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/buflomedil-article-107-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/buflomedil-article-107-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/buflomedil-article-107-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/buflomedil-article-107-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/buflomedil-article-107-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/buflomedil-article-107-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/buflomedil-article-107-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/buflomedil-article-107-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/buflomedil-article-107-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/buflomedil-article-107-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/buflomedil-article-107-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/buflomedil-article-107-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/buflomedil-article-107-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/buflomedil-article-107-referral-annex-i_sv.pdf"}},
    {"id":"20661","name":"ADHOC working group meeting on herbal medicinal products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-07-07T02:00:00Z","last_updated_date":"1998-07-07T02:00:00Z","reference_number":"EMEA/HMPC/23812/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/adhoc-working-group-meeting-herbal-medicinal-products_en.pdf"},
    {"id":"20666","name":"Overview of comments received on 'Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-23T10:44:00Z","last_updated_date":"2012-01-23T10:44:00Z","reference_number":"EMA/CVMP/EWP/249785/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-statistical-principles-clinical-trials-veterinary-medicinal-products-pharmaceuticals_en.pdf"},
    {"id":"20672","name":"EU/3/04/236: Public summary of opinion on orphan designation: Recombinant human insulin-like growth factor-I/recombinant human insulin-like growth factor binding protein-3 for the treatment of Type A extreme insulin resi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-06-21T02:00:00Z","last_updated_date":"2011-06-21T02:00:00Z","reference_number":"EMA/COMP/77786/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304236-public-summary-opinion-orphan-designation-recombinant-human-insulin-growth-factor-irecombinant-human-insulin-growth-factor-binding-protein-3-treatment-type-extreme-insulin-resi_en.pdf"},
    {"id":"20673","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the seventy fourth meeting of the committee for veterinary medicinal products took place in London on 12 - 14 February 2002.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-02-15T12:09:21Z","last_updated_date":"2002-02-15T12:09:21Z","reference_number":"EMEA/CVMP/205/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-seventy-fourth-meeting-committee-veterinary-medicinal-products-took-place-london-12-14-february-2002_en.pdf"},
    {"id":"20674","name":"Minutes - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) task force meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/871857/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-task-force-meeting_en.pdf"},
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    {"id":"20722","name":"Prevora - Article 29 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/prevora-article-29-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/prevora-article-29-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/prevora-article-29-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/prevora-article-29-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/prevora-article-29-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/prevora-article-29-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/prevora-article-29-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/prevora-article-29-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/prevora-article-29-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/prevora-article-29-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/prevora-article-29-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/prevora-article-29-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/prevora-article-29-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/prevora-article-29-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/prevora-article-29-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/prevora-article-29-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/prevora-article-29-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/prevora-article-29-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/prevora-article-29-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/prevora-article-29-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/prevora-article-29-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/prevora-article-29-referral-annex-iii_sv.pdf"}},
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    {"id":"20725","name":"Nifedipine Pharmamatch 30 and 60 mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-05-05T02:08:21Z","last_updated_date":"2006-05-05T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nifedipine-pharmamatch-30-and-60-mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"20727","name":"Codeine Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-08-02T02:00:00Z","last_updated_date":"2013-08-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-annex-iii_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/codeine-article-31-referral-annex-iii_bg.pdf-0","es":"https://www.ema.europa.eu/es/documents/referral/codeine-article-31-referral-annex-iii_es.pdf-0","cs":"https://www.ema.europa.eu/cs/documents/referral/codeine-article-31-referral-annex-iii_cs.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/codeine-article-31-referral-annex-iii_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/codeine-article-31-referral-annex-iii_de.pdf-0","et":"https://www.ema.europa.eu/et/documents/referral/codeine-article-31-referral-annex-iii_et.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/codeine-article-31-referral-annex-iii_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/codeine-article-31-referral-annex-iii_fr.pdf-0","hr":"https://www.ema.europa.eu/hr/documents/referral/codeine-article-31-referral-annex-iii_hr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/codeine-article-31-referral-annex-iii_it.pdf-0","lv":"https://www.ema.europa.eu/lv/documents/referral/codeine-article-31-referral-annex-iii_lv.pdf-0","lt":"https://www.ema.europa.eu/lt/documents/referral/codeine-article-31-referral-annex-iii_lt.pdf-0","hu":"https://www.ema.europa.eu/hu/documents/referral/codeine-article-31-referral-annex-iii_hu.pdf-0","mt":"https://www.ema.europa.eu/mt/documents/referral/codeine-article-31-referral-annex-iii_mt.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/codeine-article-31-referral-annex-iii_nl.pdf-0","pl":"https://www.ema.europa.eu/pl/documents/referral/codeine-article-31-referral-annex-iii_pl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/codeine-article-31-referral-annex-iii_pt.pdf-0","ro":"https://www.ema.europa.eu/ro/documents/referral/codeine-article-31-referral-annex-iii_ro.pdf-0","sk":"https://www.ema.europa.eu/sk/documents/referral/codeine-article-31-referral-annex-iii_sk.pdf-0","sl":"https://www.ema.europa.eu/sl/documents/referral/codeine-article-31-referral-annex-iii_sl.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/codeine-article-31-referral-annex-iii_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/codeine-article-31-referral-annex-iii_sv.pdf-0","is":"https://www.ema.europa.eu/is/documents/referral/codeine-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/codeine-article-31-referral-annex-iii_no.pdf"}},
    {"id":"20732","name":"CHMP summary of opinion for Uptravi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/826224/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-uptravi_en.pdf"},
    {"id":"20733","name":"Report from the European Medicines Agency / health-technology-assessment-body workshop on parallel scientific advice in drug development on 26 November 2013","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T16:00:00Z","last_updated_date":"2014-05-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-medicines-agency-health-technology-assessment-body-workshop-parallel-scientific-advice-drug-development-26-november-2013_en.pdf"},
    {"id":"20736","name":"Public statement on Thelin: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2011-03-02T01:00:00Z","last_updated_date":"2011-03-02T01:00:00Z","reference_number":"EMA/149536/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-thelin-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"20738","name":"Presentation - CT for prevention/treatment of BPD (Ninna Gullber)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ct-preventiontreatment-bpd-ninna-gullber_en.pdf"},
    {"id":"20739","name":"EU/3/13/1166: Public summary of opinion on orphan designation: Heterologous human adult liver-derived progenitor cells for the treatment of citrullinaemia type 2","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T17:30:00Z","last_updated_date":"2013-08-22T17:30:00Z","reference_number":"EMA/COMP/413220/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131166-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-progenitor-cells-treatment-citrullinaemia-type-2_en.pdf"},
    {"id":"20740","name":"Presentation - Development of drugs for skin infections","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:52Z","last_updated_date":"2011-04-26T18:05:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-skin-infections_en.pdf"},
    {"id":"20741","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 March 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-04-11T18:04:00Z","last_updated_date":"2017-04-11T18:04:00Z","reference_number":"EMA/PDCO/209961/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-21-24-march-2017_en.pdf"},
    {"id":"20742","name":"Committee for medicinal products for human use, summary of positive opinion for Opgenra","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-10-23T02:00:00Z","last_updated_date":"2016-07-14T02:00:00Z","reference_number":"EMEA/CHMP/558609/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-opgenra_en.pdf"},
    {"id":"20743","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - May 2015","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-07-01T12:50:00Z","last_updated_date":"2015-07-01T12:50:00Z","reference_number":"EMA/353327/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-may-2015_en.pdf"},
    {"id":"20744","name":"European Medicines Agency recommends suspension of marketing authorisation of aprotinin-containing medicines for systemic use","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-12-21T00:09:21Z","last_updated_date":"2007-12-21T00:09:21Z","reference_number":"EMEA/534678/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-marketing-authorisation-aprotinin-containing-medicines-systemic-use_en.pdf"},
    {"id":"20745","name":"CHMP summary of positive opinion for Xgeva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/383964/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xgeva_en.pdf"},
    {"id":"20747","name":"Presentation - The regulator’s perspective - Session 3 (Seà¡n Barry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulators-perspective-session-3-sean-barry_en.pdf"},
    {"id":"20749","name":"Evaluation of immunogenicity of pharmaceuticals - Geoff Hale","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-09-04T02:09:21Z","last_updated_date":"2007-09-04T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/evaluation-immunogenicity-pharmaceuticals-geoff-hale_en.pdf"},
    {"id":"20754","name":"Agenda - Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma kinase aberrations)","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/764474/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-multi-stakeholder-paediatric-oncology-strategy-workshop-cancers-anaplastic-lymphoma-kinase-aberrations_en.pdf"},
    {"id":"20761","name":"Benzyl alcohol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-01-01T01:00:00Z","last_updated_date":"1997-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/benzyl-alcohol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20763","name":"Guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-06-01T17:00:00Z","last_updated_date":"2015-06-01T17:00:00Z","reference_number":"EMA/CHMP/BPWP/144552/2009 Rev.1 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-ix-products-revision-1_en.pdf"},
    {"id":"20764","name":"European Medicines Agency sees no safety concerns with the Rotarix oral vaccine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/CHMP/201923/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-sees-no-safety-concerns-rotarix-oral-vaccine_en.pdf"},
    {"id":"20770","name":"Explanatory note on the withdrawal of the Note for guidance on harmonisation of requirements for influenza Vaccines and of the core SmPC/PL for inactivated seasonal influenza vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"EMA/CHMP/VWP/40560/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/explanatory-note-withdrawal-note-guidance-harmonisation-requirements-influenza-vaccines-and-core-smpcpl-inactivated-seasonal-influenza-vaccines_en.pdf"},
    {"id":"20771","name":"Public statement committee for medicinal products for veterinary use meeting of 16-18 May 2006","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-05-19T02:00:00Z","last_updated_date":"2006-05-19T02:00:00Z","reference_number":"EMEA/CVMP/168467/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-committee-medicinal-products-veterinary-use-meeting-16-18-may-2006_en.pdf"},
    {"id":"20772","name":"CHMP summary of positive opinion for Edarbi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/736839/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-edarbi_en.pdf"},
    {"id":"20774","name":"Fourth pandemic pharmacovigilance weekly update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-12-23T00:09:21Z","last_updated_date":"2009-12-23T00:09:21Z","reference_number":"EMA/841003/2009","document_url":"https://www.ema.europa.eu/en/documents/report/fourth-pandemic-pharmacovigilance-weekly-update_en.pdf"},
    {"id":"20776","name":"Viable autologous adipose tissue-derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-07-11T13:00:00Z","last_updated_date":"2014-07-11T13:00:00Z","reference_number":"EMA/414098/2014","document_url":"https://www.ema.europa.eu/en/documents/report/viable-autologous-adipose-tissue-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"20777","name":"Balsamum peruvianum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/356/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/balsamum-peruvianum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20778","name":"EU/3/12/986: Public summary of opinion on orphan designation: Pomalidomide for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:55:00Z","last_updated_date":"2015-06-08T16:55:00Z","reference_number":"EMA/COMP/216971/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312986-public-summary-opinion-orphan-designation-pomalidomide-treatment-systemic-sclerosis_en.pdf"},
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    {"id":"20818","name":"Fournier Laboratories withdraws its marketing authorisation application for Synordia","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-12-08T01:00:00Z","last_updated_date":"2006-12-08T01:00:00Z","reference_number":"EMEA/495743/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/fournier-laboratories-withdraws-its-marketing-authorisation-application-synordia_en.pdf"},
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    {"id":"20830","name":"Apocynum cannabinum: Summary report  Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/596/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/apocynum-cannabinum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20831","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Ranibizumab for treatment of retinopathy of prematurity","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T11:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/511523/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-ranibizumab-treatment-retinopathy-prematurity_en.pdf"},
    {"id":"20832","name":"RepliGen Europe Limited withdraws its marketing authorisation application for SecreFlo (secretin human)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-09-14T12:00:00Z","last_updated_date":"2012-09-14T12:00:00Z","reference_number":"EMA/597126/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/repligen-europe-limited-withdraws-its-marketing-authorisation-application-secreflo-secretin-human_en.pdf"},
    {"id":"20835","name":"List of bibliographic references supporting the HMPC assessment report\n\non Plantago ovata Forssk., seminis tegumentum (EMEA/HMPC/165838/2006)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-bibliographic-references-supporting-hmpc-assessment-report-plantago-ovata-forssk-seminis-tegumentum-emeahmpc1658382006_en.pdf"},
    {"id":"20836","name":"Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-09-10T02:09:21Z","last_updated_date":"2004-09-10T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/directive-200183ec-european-parliament-and-council-6-november-2001-community-code-relating-medicinal-products-human-use_en.pdf"},
    {"id":"20838","name":"Final public statement on Chelidonium majus L., herba","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/HMPC/743927/2010","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-chelidonium-majus-l-herba_en.pdf"},
    {"id":"20839","name":"Summary of the evaluation of the proposed paediatric investigation plan: Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-19T02:00:00Z","last_updated_date":"2015-10-19T02:00:00Z","reference_number":"EMA/179045/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-chimeric-anti-disialoganglioside-gd2-monoclonal-antibody-ch1418cho-apn311_en.pdf"},
    {"id":"20841","name":"Introduction to the draft budget 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/MB/784261/2010","document_url":"https://www.ema.europa.eu/en/documents/other/introduction-draft-budget-2011_en.pdf"},
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    {"id":"20848","name":"Deltamethrin (Extrapolation to all ruminants): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/MRL/893/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/deltamethrin-extrapolation-all-ruminants-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20851","name":"Enhanced early dialogue to facilitate accelerated assessment of PRIority MEdicines (PRIME)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2018-05-07T17:30:00Z","reference_number":"EMA/CHMP/57760/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/enhanced-early-dialogue-facilitate-accelerated-assessment-priority-medicines-prime_en.pdf"},
    {"id":"20852","name":"Presentation - Session 2.6: Examples of interactions - Accelerate (Gilles Vassal, Gustave Roussy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-26-examples-interactions-accelerate-gilles-vassal-gustave-roussy_en.pdf"},
    {"id":"20855","name":"Final European Union herbal monograph on Sisymbrium officinale (L.) Scop., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-10-30T01:00:00Z","last_updated_date":"2014-10-30T01:00:00Z","reference_number":"EMA/HMPC/280193/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"20861","name":"Penethamate (Hydriodide): Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-18T01:00:00Z","last_updated_date":"1997-02-18T01:00:00Z","reference_number":"EMEA/CVMP/022-REV1/MRL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/penethamate-hydriodide-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20863","name":"Ikorel and Dancor Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ikorel-and-dancor-article-30-referral-annex-i_sv.pdf"}},
    {"id":"20866","name":"Presentation - Adapting to Community referrals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adapting-community-referrals_en.pdf"},
    {"id":"20868","name":"Draft guideline on potency testing of cell based immunotherapy medicinal products for the treatment of cancer","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-10-11T02:00:00Z","last_updated_date":"2006-10-11T02:00:00Z","reference_number":"EMEA/CHMP/BWP/271475/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancer_en.pdf"},
    {"id":"20869","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Strensiq (asfotase alfa) for the treatment of hypophosphatasia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-09-28T02:00:00Z","last_updated_date":"2015-09-28T02:00:00Z","reference_number":"EMA/COMP/471205/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-strensiq-asfotase-alfa-treatment-hypophosphatasia_en.pdf"},
    {"id":"20870","name":"Work programme for the European Agency for the Evaluation of Medicinal Products 1998-1999","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"1998-10-13T02:09:21Z","last_updated_date":"1998-10-13T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1998-1999_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1998-1999_es.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1998-1999_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-1998-1999_fr.pdf"}},
    {"id":"20873","name":"Reflection paper on markers used for quantitative and qualitative\n\nanalysis of herbal medicinal products and traditional herbal\n\nmedicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-07-15T02:00:00Z","last_updated_date":"2008-07-15T02:00:00Z","reference_number":"EMEA/HMPC/253629/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-markers-used-quantitative-and-qualitative-analysis-herbal-medicinal-products-and-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"20874","name":"Overview of comments on ‘Ticagrelor film-coated tablets 90mg product specific bioequivalence guidance’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/CHMP/206139/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-ticagrelor-film-coated-tablets-90mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"20875","name":"Presentation - The added value of Twitter (K. Plass, EAU)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-added-value-twitter-k-plass-eau_en.pdf"},
    {"id":"20877","name":"Novartis Vaccines and Diagnostics S.r.l. withdraws its application for paediatric use marketing authorisation for Fluad Paediatric (influenza vaccine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T15:00:00Z","last_updated_date":"2012-02-16T15:00:00Z","reference_number":"EMA/112567/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/novartis-vaccines-and-diagnostics-srl-withdraws-its-application-paediatric-use-marketing-authorisation-fluad-paediatric-influenza-vaccine_en.pdf"},
    {"id":"20879","name":"Lespedeza capitata: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/419/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lespedeza-capitata-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20881","name":"Mock-ups and specimens: Response form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-04-05T17:10:00Z","last_updated_date":"2013-04-05T17:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/mock-ups-and-specimens-response-form_en.doc"},
    {"id":"20883","name":"Agenda and registration form - EMA/DIA statistics forum: The role of observational data in assessing the benefits and risks of drugs","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-09-20T02:00:00Z","last_updated_date":"2017-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-emadia-statistics-forum-role-observational-data-assessing-benefits-and-risks-drugs_en.pdf"},
    {"id":"20884","name":"CHMP post-authorisation summary of positive opinion for Exforge","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/CHMP/388283/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-exforge_en.pdf"},
    {"id":"20885","name":"Committee for veterinary medicinal products: 61st meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-12-07T12:49:21Z","last_updated_date":"2000-12-07T12:49:21Z","reference_number":"EMEA/CVMP/967/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-61st-meeting_en.pdf"},
    {"id":"20888","name":"Ivermectin (topical use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"20896","name":"Jinarc recommended for approval in rare kidney disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/CHMP/130684/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/jinarc-recommended-approval-rare-kidney-disease_en.pdf"},
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    {"id":"20923","name":"EU/3/08/555: Public summary of positive opinion for orphan designation of vincristine sulphate liposomes for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2011-06-21T02:00:00Z","reference_number":"EMEA/COMP/449452/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308555-public-summary-positive-opinion-orphan-designation-vincristine-sulphate-liposomes-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"20925","name":"Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2017","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-04-16T15:00:00Z","last_updated_date":"2018-04-16T15:00:00Z","reference_number":"EMA/845953/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-dialogue-meeting-december-2017_en.pdf"},
    {"id":"20926","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting -  February 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-february-2012_en.pdf"},
    {"id":"20927","name":"Practical information on translations for referral procedures (human)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-12-19T09:45:00Z","last_updated_date":"2013-11-28T10:19:00Z","reference_number":"EMA/583202/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-information-translations-referral-procedures-human_en.pdf"},
    {"id":"20928","name":"EU/3/16/1633: Public summary of opinion on orphan designation: Fosbretabulin tromethamine for the treatment of gastro-entero-pancreatic neuroendocrine tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"EMA/COMP/172769/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161633-public-summary-opinion-orphan-designation-fosbretabulin-tromethamine-treatment-gastro-entero-pancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"20929","name":"Superseded assessment report on Centaurium erythraea Rafn s. L. including C. majus (H. et L.) Zeltner and C. suffruticosum (griseb.) Ronn., herba, for the development of a community herbal monograph","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T00:09:21Z","last_updated_date":"2016-01-28T00:09:21Z","reference_number":"EMEA/HMPC/105535/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-centaurium-erythraea-rafn-s-l-including-c-majus-h-et-l-zeltner-and-c-suffruticosum-griseb-ronn-herba-development-community-herbal-monograph_en.pdf"},
    {"id":"20930","name":"Tildren - Article 33 referral - Annexes I, II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-12-14T01:00:00Z","last_updated_date":"2010-12-14T01:00:00Z","reference_number":"EMA/193771/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/tildren-article-33-referral-annexes-i-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tildren-article-33-referral-annexes-i-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tildren-article-33-referral-annexes-i-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tildren-article-33-referral-annexes-i-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tildren-article-33-referral-annexes-i-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tildren-article-33-referral-annexes-i-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tildren-article-33-referral-annexes-i-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tildren-article-33-referral-annexes-i-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tildren-article-33-referral-annexes-i-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tildren-article-33-referral-annexes-i-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tildren-article-33-referral-annexes-i-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tildren-article-33-referral-annexes-i-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tildren-article-33-referral-annexes-i-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tildren-article-33-referral-annexes-i-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tildren-article-33-referral-annexes-i-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tildren-article-33-referral-annexes-i-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tildren-article-33-referral-annexes-i-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tildren-article-33-referral-annexes-i-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tildren-article-33-referral-annexes-i-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tildren-article-33-referral-annexes-i-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tildren-article-33-referral-annexes-i-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tildren-article-33-referral-annexes-i-ii_sv.pdf"}},
    {"id":"20932","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting -  June 2010","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-june-2010_en.pdf"},
    {"id":"20935","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-11-30T01:00:00Z","last_updated_date":"2003-11-30T01:00:00Z","reference_number":"CPMP/ICH/3945/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-topic-e-2-d-postapproval-safety-data-management-step-5_en.pdf"},
    {"id":"20936","name":"CHMP summary of positive opinion for Lamivudine/Zidovudine Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2023-03-21T01:00:00Z","reference_number":"EMA/725978/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lamivudinezidovudine-teva_en.pdf"},
    {"id":"20937","name":"Baxter dialysis solutions Article-31 referral - Annex IV (3 sites)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-3-sites_sv.pdf"}},
    {"id":"20939","name":"Human Embryonic Stem Cells: Considerations for Therapeutic Product Development, Dr Jane S. Lebkowski, Geron Corporation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/human-embryonic-stem-cells-considerations-therapeutic-product-development-dr-jane-s-lebkowski-geron-corporation_en.pdf"},
    {"id":"20940","name":"Bupropion: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"20941","name":"Committee on herbal medicinal products (HMPC): Meeting report, 22-23 March 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-05-11T02:00:00Z","last_updated_date":"2005-05-11T02:00:00Z","reference_number":"EMEA/HMPC/119829/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-22-23-march-2005_en.pdf"},
    {"id":"20942","name":"Presentation - Topic 1 - Assessment of paediatric medical needs through the Dutch Paediatric Formulary - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Tjitske van der Zand...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-1-assessment-paediatric-medical-needs-through-dutch-paediatric-formulary-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-tjitske-van-der-zand_en.pdf"},
    {"id":"20943","name":"Best practice guide for staff leaving the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-14T14:15:00Z","last_updated_date":"2015-08-21T12:00:00Z","reference_number":"EMA/70197/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/best-practice-guide-staff-leaving-european-medicines-agency_en.pdf"},
    {"id":"20944","name":"Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-30T11:10:03Z","last_updated_date":"2013-03-27T13:20:00Z","reference_number":"EMA/MB/112878/2013","document_url":"https://www.ema.europa.eu/en/documents/other/rules-implementation-council-regulation-ec-no-29795-fees-payable-european-medicines-agency-and-other-measures_en.pdf-1"},
    {"id":"20945","name":"Modafinil - Annex III - Summary of product characteristics, labeling or package leaflet","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2010-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/modafinil-annex-iii-summary-product-characteristics-labeling-or-package-leaflet_en.pdf"},
    {"id":"20947","name":"Argatroban: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00009057/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-03T01:00:00Z","last_updated_date":"2016-10-17T19:40:19Z","reference_number":"EMA/64666/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/argatroban-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00009057201501_en.pdf"},
    {"id":"20948","name":"Presentation - PDCO's perspective: Regulatory challenges and opportunities - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines (D. ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdcos-perspective-regulatory-challenges-and-opportunities-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"20950","name":"Presentation - 3.2 Feedback from the Heads of Medicines Agencies meeting in April","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T12:00:00Z","last_updated_date":"2011-11-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-32-feedback-heads-medicines-agencies-meeting-april_en.pdf"},
    {"id":"20951","name":"More information on Human & Veterinary Medicinal Products' Regulation - Turkey's Road to EU Membership","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-22T02:09:21Z","last_updated_date":"2007-10-22T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/more-information-human-veterinary-medicinal-products-regulation-turkeys-road-eu-membership_en.pdf"},
    {"id":"20953","name":"EudraVigilance - Key milestones and summary of associated EudraVigilance auditable requirements project communications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-26T01:00:00Z","last_updated_date":"2017-06-26T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-key-milestones-and-summary-associated-eudravigilance-auditable-requirements-project-communications_en.pdf"},
    {"id":"20954","name":"Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-20T16:45:00Z","last_updated_date":"2018-07-20T16:45:00Z","reference_number":"EMA/CHMP/BPWP/94038/2007 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-human-normal-immunoglobulin-intravenous-administration-ivig-rev-5_en.pdf"},
    {"id":"20957","name":"Public statement on Infliximab (Remicade) - Reports of tuberculosis infections","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-12-20T01:00:00Z","last_updated_date":"2000-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/public-statement-infliximab-remicade-reports-tuberculosis-infections_en.pdf"},
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    {"id":"20960","name":"Final list of references supporting the assessment of Piper methysticum G. Forst., rhizoma","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2018-04-13T02:00:00Z","reference_number":"EMA/HMPC/450587/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-piper-methysticum-g-forst-rhizoma_en.pdf"},
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    {"id":"20964","name":"European Medicines Agency recommends lifting of supply and treatment restrictions for Neupro","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:09:21Z","last_updated_date":"2009-05-29T02:09:21Z","reference_number":"EMEA/CHMP/322964/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-lifting-supply-and-treatment-restrictions-neupro_en.pdf"},
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    {"id":"20973","name":"Testosterone Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2015-01-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/testosterone-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/testosterone-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/testosterone-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/testosterone-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/testosterone-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/testosterone-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/testosterone-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/testosterone-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/testosterone-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/testosterone-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/testosterone-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/testosterone-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/testosterone-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/testosterone-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/testosterone-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/testosterone-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/testosterone-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/testosterone-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/testosterone-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/testosterone-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/testosterone-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/testosterone-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/testosterone-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/testosterone-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/testosterone-article-31-referral-annex-iii_no.pdf"}},
    {"id":"20975","name":"Re-examination procedure of paediatric investigation plan and / or waiver opinions by the PDCO","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-01-29T01:00:00Z","last_updated_date":"2015-01-21T16:15:00Z","reference_number":"EMEA/23604/2008 Re. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/re-examination-procedure-paediatric-investigation-plan-and-or-waiver-opinions-pdco_en.pdf"},
    {"id":"20976","name":"CHMP post authorisation summary of positive opinion for Xelivia on 25 June 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/369153/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xelivia-25-june-2009_en.pdf"},
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    {"id":"20978","name":"Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension: Endpoints – Patients perspective (P. Hassel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emafdahealth-canada-workshop-paediatric-pulmonary-arterial-hypertension-endpoints-patients-perspective-p-hassel_en.pdf"},
    {"id":"20980","name":"EU/3/12/1062: Public summary of opinion on orphan designation: Chimeric monoclonal antibody against GD2 for the treatment of neuroblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2012-12-12T01:00:00Z","reference_number":"EMA/COMP/663138/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121062-public-summary-opinion-orphan-designation-chimeric-monoclonal-antibody-against-gd2-treatment-neuroblastoma_en.pdf"},
    {"id":"20982","name":"Beclometasone dipropionate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/MRL/905/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/beclometasone-dipropionate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"20983","name":"Sulbactam: List of nationally authorised medicinal products - PSUSA/00002800/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-04T18:30:00Z","last_updated_date":"2017-09-04T18:30:00Z","reference_number":"EMA/580068/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/sulbactam-list-nationally-authorised-medicinal-products-psusa00002800201611_en.pdf"},
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    {"id":"20985","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting 17-20 March 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T17:00:00Z","last_updated_date":"2014-03-24T17:00:00Z","reference_number":"EMA/122464/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-17-20-march-2014_en.pdf"},
    {"id":"20986","name":"Overview of comments received on community herbal monograph on Curcuma longa L., rhizoma - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2010-02-04T01:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"EMA/HMPC/401918/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-curcuma-longa-l-rhizoma-first-version_en.pdf"},
    {"id":"20987","name":"Public statement: Risk of peripheral neuropathy with Sebivo (telbivudine)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-02-14T00:09:21Z","last_updated_date":"2008-02-14T00:09:21Z","reference_number":"EMEA/60439/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-risk-peripheral-neuropathy-sebivo-telbivudine_en.pdf"},
    {"id":"20988","name":"Presentation - New mandates for PCWP and HCPWP (2016-2019) (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-mandates-pcwp-and-hcpwp-2016-2019-nathalie-bere_en.pdf"},
    {"id":"20991","name":"PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/169618/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-further-measures-minimise-risk-osteonecrosis-jaw-bisphosphonate-medicine_en.pdf"},
    {"id":"20993","name":"Committee for Medicinal Products for Human Use (CHMP) - May 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-06-05T02:00:00Z","last_updated_date":"2003-06-05T02:00:00Z","reference_number":"EMEA/CPMP/2568/03/Rev 01","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-may-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"20994","name":"Autologous T-cells expressing a chimeric NKG2D receptor","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T16:33:00Z","last_updated_date":"2016-11-15T16:33:00Z","reference_number":"EMA/693976/2016","document_url":"https://www.ema.europa.eu/en/documents/report/autologous-t-cells-expressing-chimeric-nkg2d-receptor_en.pdf"},
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    {"id":"21027","name":"Template for submission of comments on draft European Union herbal monograph or draft  European Union list entry","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:00Z","last_updated_date":"2020-07-29T15:10:00Z","reference_number":"EMA/HMPC/384286/2006","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-submission-comments-draft-european-union-herbal-monograph-or-draft-european-union-list-entry_en.doc"},
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    {"id":"21032","name":"Withdrawal letter: Aivlosin","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2014-07-21T18:00:00Z","last_updated_date":"2014-07-21T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aivlosin_en.pdf"},
    {"id":"21033","name":"Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future - A joint conference of the European Commission and the European Medicines Agency - Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2007-11-30T00:09:21Z","last_updated_date":"2007-11-30T00:09:21Z","reference_number":"EMEA/565466/2007","document_url":"https://www.ema.europa.eu/en/documents/report/operation-clinical-trials-directive-directive-200120ec-and-perspectives-future-joint-conference-european-commission-and-european-medicines-agency-report_en.pdf"},
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    {"id":"21038","name":"Lewy body dementias - Target population and specific end points - Ian McKeith","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-11T00:09:21Z","last_updated_date":"2008-02-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/lewy-body-dementias-target-population-and-specific-end-points-ian-mckeith_en.pdf"},
    {"id":"21039","name":"Cabergoline (bovine): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-18T02:00:00Z","last_updated_date":"2014-08-18T02:00:00Z","reference_number":"EMA/CVMP/656490/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cabergoline-bovine-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"21042","name":"Combined hormonal contraceptives: Article-31 referral - Notification","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T13:00:00Z","last_updated_date":"2013-02-08T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-notification_en.pdf"},
    {"id":"21043","name":"EU/3/05/314: Public summary of positive opinion for orphan designation\n\nof (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol for the treatment of tuberculosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2014-04-01T17:10:00Z","reference_number":"EMA/COMP/247350/2005 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305314-public-summary-positive-opinion-orphan-designation-1r2s-6-bromo-alpha-2-dimethylaminoethyl-2-methoxy-alpha-1-naphthyl-beta-phenyl-3-quinolineethanol-treatment-tuberculosis_en.pdf"},
    {"id":"21044","name":"Presentation - Involvement of children and young people in the Paediatric Committee activities (Elin Haf Davies)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-24T18:30:00Z","last_updated_date":"2013-05-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-involvement-children-and-young-people-paediatric-committee-activities-elin-haf-davies_en.pdf"},
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    {"id":"21052","name":"PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-05-18T14:00:00Z","last_updated_date":"2018-05-18T14:00:00Z","reference_number":"EMA/289137/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-new-measures-minimise-risk-rare-serious-liver-injury-esmya-fibroids_en.pdf"},
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    {"id":"21056","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Sept 2016)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-08-19T02:00:00Z","last_updated_date":"2016-08-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-sept-2016_en.pdf"},
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    {"id":"21061","name":"Valproate and related substances Article-31 referral - PRAC assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T14:00:00Z","last_updated_date":"2014-11-14T14:00:00Z","reference_number":"EMA/686022/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-and-related-substances-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"21063","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel HCS","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2009-06-25T02:09:21Z","reference_number":"EMEA/CHMP/379509/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-hcs_en.pdf"},
    {"id":"21065","name":"Amoxicillin : List of nationally authorised medicinal products - PSUSA/00000187/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-06T17:20:00Z","last_updated_date":"2017-11-06T17:23:26Z","reference_number":"EMA/726434/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/amoxicillin-list-nationally-authorised-medicinal-products-psusa00000187201703_en.pdf"},
    {"id":"21066","name":"Superseded assessment report on Echinacea pallida (nutt.) nutt., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:09:21Z","last_updated_date":"2018-08-14T02:09:21Z","reference_number":"EMEA/HMPC/332358/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-echinacea-pallida-nutt-nutt-radix_en.pdf"},
    {"id":"21068","name":"Ibuprofen and dexibuprofen Article-31 referral - PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-06-13T17:00:00Z","last_updated_date":"2014-06-13T17:00:00Z","reference_number":"EMA/PRAC/332909/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"21069","name":"Questions and answers on the expression of the strength for Halaven (eribulin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T13:00:00Z","last_updated_date":"2012-02-17T13:00:00Z","reference_number":"EMA/105039/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-expression-strength-halaven-eribulin_en.pdf"},
    {"id":"21070","name":"EU/3/10/728: Public summary of opinion on orphan designation: Davunetide for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2013-06-25T02:00:00Z","reference_number":"EMA/COMP/23524/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310728-public-summary-opinion-orphan-designation-davunetide-treatment-progressive-supranuclear-palsy_en.pdf"},
    {"id":"21071","name":"Presentation - Feedback from PDCO (J. Taminiau, PDCO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-pdco-j-taminiau-pdco_en.pdf"},
    {"id":"21072","name":"Interested parties to the HMPC","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-11-26T01:00:00Z","last_updated_date":"2022-11-30T13:30:00Z","reference_number":"EMA/HMPC/14070/2013","document_url":"https://www.ema.europa.eu/en/documents/other/interested-parties-hmpc_en.pdf"},
    {"id":"21073","name":"Important changes to the Controlled Vocabulary lists: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Pharmaceutical Dose Forms and Routes of Administration","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-07T18:10:00Z","last_updated_date":"2013-11-07T18:10:00Z","reference_number":"EMA/650540/2013","document_url":"https://www.ema.europa.eu/en/documents/other/important-changes-controlled-vocabulary-lists-extended-eudravigilance-medicinal-product-dictionary-xevmpd-pharmaceutical-dose-forms-and-routes-administration_en.pdf"},
    {"id":"21075","name":"Presentation - Survey on the communication practices during a pandemic influenza crisis (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-communication-practices-during-pandemic-influenza-crisis-ivana-silva_en.pdf"},
    {"id":"21077","name":"Committee for medicinal products for human use summary of positive opinion for Eporatio","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:09:21Z","last_updated_date":"2009-07-23T02:09:21Z","reference_number":"EMEA/CHMP/469178/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-eporatio_en.pdf"},
    {"id":"21078","name":"Medication errors - Follow-up actions from workshop: Implementation plan 2014-2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-16T13:30:00Z","last_updated_date":"2014-04-16T13:30:00Z","reference_number":"EMA/20791/2014","document_url":"https://www.ema.europa.eu/en/documents/other/medication-errors-follow-actions-workshop-implementation-plan-2014-2015_en.pdf"},
    {"id":"21079","name":"Guideline on procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organization for the evaluation of medicinal products intended exclusively for markets outside the C...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"EMEA/CHMP/5579/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-procedural-aspects-regarding-chmp-scientific-opinion-context-cooperation-world-health-organization-evaluation-medicinal-products-intended-exclusively-markets-outside-c_en.pdf"},
    {"id":"21080","name":"Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Hydrocortisone aceponate","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-09-21T15:32:00Z","last_updated_date":"2016-09-21T15:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits-hydrocortisone-aceponate_en.pdf"},
    {"id":"21081","name":"Presentation - Background to the meeting: paediatric investigation plans for Gaucher (Elin Haf Davies)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-28T01:00:00Z","last_updated_date":"2012-11-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-background-meeting-paediatric-investigation-plans-gaucher-elin-haf-davies_en.pdf"},
    {"id":"21082","name":"Captopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000536/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T16:15:00Z","last_updated_date":"2017-01-27T16:20:14Z","reference_number":"EMA/45259/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/captopril-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00000536201604_en.pdf"},
    {"id":"21085","name":"EMEA Creates new Communications and Networking Unit","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-10-18T02:00:00Z","last_updated_date":"2001-10-18T02:00:00Z","reference_number":"EMEA/D/27597/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-creates-new-communications-and-networking-unit_en.pdf"},
    {"id":"21087","name":"Overview of comments on draft Public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-07-27T16:00:00Z","last_updated_date":"2016-07-27T16:00:00Z","reference_number":"EMA/HMPC/258725/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-draft-public-statement-use-herbal-medicinal-products-containing-pulegone-and-menthofuran-revision-1_en.pdf"},
    {"id":"21088","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: EuroNeoNet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817558/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-euroneonet_en.pdf"},
    {"id":"21089","name":"Gadolinium Article-31 referral – Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-annex-iii_en.pdf"},
    {"id":"21090","name":"Presentation - Heterogeneity: How much is too much?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-heterogeneity-how-much-too-much_en.pdf"},
    {"id":"21091","name":"Declaration of interests: Luc Vanheel","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-18T01:00:00Z","last_updated_date":"2014-11-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-luc-vanheel_en.pdf"},
    {"id":"21092","name":"Final list of references supporting the assessment of Achillea millefolium L., flos","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2011-09-30T02:00:00Z","last_updated_date":"2011-09-30T02:00:00Z","reference_number":"EMA/HMPC/149469/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-achillea-millefolium-l-flos_en.pdf"},
    {"id":"21093","name":"Asparaginase: List of nationally authorised medicinal products - PSUSA/00003161/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-15T02:00:00Z","last_updated_date":"2016-10-17T19:40:10Z","reference_number":"EMA/407532/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/asparaginase-list-nationally-authorised-medicinal-products-psusa00003161201508_en.pdf"},
    {"id":"21096","name":"EPAR summaries for the public: A further step for the provision of better information about medicines.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-02-02T01:00:00Z","last_updated_date":"2006-02-02T01:00:00Z","reference_number":"EMEA/40317/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/epar-summaries-public-further-step-provision-better-information-about-medicines_en.pdf"},
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    {"id":"21099","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (2016)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T13:45:00Z","last_updated_date":"2016-03-11T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-2016_en.pdf"},
    {"id":"21100","name":"EU/3/09/722: Public summary of opinion on orphan designation of pixantrone dimaleate for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMA/COMP/814908/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309722-public-summary-opinion-orphan-designation-pixantrone-dimaleate-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
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    {"id":"21102","name":"Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-13T18:32:00Z","last_updated_date":"2018-09-13T18:34:00Z","reference_number":"EMA/615366/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/sertindole-list-nationally-authorised-medicinal-products-psusa00002695201801_en.pdf"},
    {"id":"21104","name":"Towards a robust global framework for conduct and oversight of clinical trials","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-04-16T19:18:01Z","last_updated_date":"2012-04-16T19:18:01Z","reference_number":"EMA/219517/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/towards-robust-global-framework-conduct-and-oversight-clinical-trials_en.pdf"},
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    {"id":"21111","name":"CHMP post-authorisation summary of positive opinion for Ilaris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T14:00:00Z","last_updated_date":"2016-06-24T14:00:00Z","reference_number":"EMA/CHMP/421628/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ilaris_en.pdf-1"},
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    {"id":"21119","name":"Work plan for the Working Party on European Union Monographs and List (MLWP) 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-02-27T18:15:00Z","last_updated_date":"2018-03-09T16:00:00Z","reference_number":"EMA/HMPC/142826/2018","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-working-party-european-union-monographs-and-list-mlwp-2018_en.pdf"},
    {"id":"21121","name":"Draft assessment report on Arnica montana L., flos","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-08-22T02:00:00Z","last_updated_date":"2013-08-22T02:00:00Z","reference_number":"EMA/HMPC/198794/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-arnica-montana-l-flos_en.pdf"},
    {"id":"21123","name":"Presentation - What is an ideal PSUR? – A new focus based on aligned expectations (Margarida Guimarà£es)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-ideal-psur-new-focus-based-aligned-expectations-margarida-guimarapses_en.pdf"},
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    {"id":"21128","name":"Suanovil 20 / Captalin Article-35 referral - Divergent position on a CVMP opinion on an Article 35 of Directive 2001/82/EC","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-02-03T01:00:00Z","last_updated_date":"2015-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/suanovil-20-captalin-article-35-referral-divergent-position-cvmp-opinion-article-35-directive-200182ec_en.pdf"},
    {"id":"21129","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Darzalex (daratumumab) for the treatment of plasma cell myeloma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-06-08T18:00:00Z","last_updated_date":"2016-06-08T18:00:00Z","reference_number":"EMA/COMP/332269/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-darzalex-daratumumab-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"21130","name":"EMEA workshop - Announcement - Medicines for bees - What the EMEA can do to increase availability","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-10-16T02:09:21Z","last_updated_date":"2009-10-16T02:09:21Z","reference_number":"EMEA/627827/2009","document_url":"https://www.ema.europa.eu/en/documents/other/emea-workshop-announcement-medicines-bees-what-emea-can-do-increase-availability_en.pdf"},
    {"id":"21133","name":"Public statement on Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals (prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/20...","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-03-21T01:00:00Z","last_updated_date":"2012-03-21T01:00:00Z","reference_number":"EMA/844313/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-biologicals-prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted_en.pdf"},
    {"id":"21135","name":"Procedure for conducting pharmacovigilance inspections requested by the CVMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-20T02:00:00Z","last_updated_date":"2009-04-20T02:00:00Z","reference_number":"EMEA/INS/PhV/85058/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-conducting-pharmacovigilance-inspections-requested-cvmp_en.pdf"},
    {"id":"21136","name":"Pulmotil AC - Article 34 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:08:21Z","last_updated_date":"2009-12-23T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/pulmotil-ac-article-34-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"21137","name":"Lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-11-01T17:31:34Z","reference_number":"EMA/CHMP/177335/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lenalidomide-hard-gelatine-capsules-25-5-75-10-15-and-25mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"21138","name":"Revision of budget structure from financial year 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-06T17:00:00Z","last_updated_date":"2017-10-06T17:00:00Z","reference_number":"EMA/MB/573458/2017","document_url":"https://www.ema.europa.eu/en/documents/report/revision-budget-structure-financial-year-2018_en.pdf"},
    {"id":"21140","name":"Eprinomectin (extention to ovine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-05T10:05:00Z","last_updated_date":"2013-03-05T10:05:00Z","reference_number":"EMA/CVMP/29109/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/eprinomectin-extention-ovine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"21141","name":"Committee for Orphan Medicinal Products: November 2006 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-11-09T01:00:00Z","last_updated_date":"2006-11-09T01:00:00Z","reference_number":"EMEA/COMP/439303/2006 corr.","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-november-2006-meeting_en.pdf"},
    {"id":"21151","name":"Final list of references supporting the assessment of Chamaemelum nobile (L.) All., flos","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T17:20:00Z","last_updated_date":"2012-01-20T17:20:00Z","reference_number":"EMA/HMPC/560733/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"21152","name":"The Paediatric Regulation - Agnà©s Saint Raymond","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-06T02:09:21Z","last_updated_date":"2007-06-06T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/paediatric-regulation-agnacs-saint-raymond_en.pdf"},
    {"id":"21158","name":"EU/3/04/189: Public summary of positive opinion for orphan designation of idebenone for the treatment of Friedreich’s ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-10T00:00:00Z","last_updated_date":"2011-04-12T01:00:00Z","reference_number":"EMEA/COMP/72/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304189-public-summary-positive-opinion-orphan-designation-idebenone-treatment-friedreichs-ataxia_en.pdf"},
    {"id":"21161","name":"Public statement on Libertek: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-02-08T13:00:00Z","last_updated_date":"2018-02-08T13:00:00Z","reference_number":"EMA/58494/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-libertek-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"21162","name":"EU/3/10/832: Public summary of opinion on orphan designation: Deferiprone for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2011-03-04T01:00:00Z","reference_number":"EMA/COMP/740288/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310832-public-summary-opinion-orphan-designation-deferiprone-treatment-sickle-cell-disease_en.pdf"},
    {"id":"21163","name":"Superseded assessment report for the development of community herbal monographs and for inclusion of herbal substance(s), preparation(s) or combinations thereof in the community list Calendula officinalis L., flos - Firs...","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-03-06T00:09:21Z","last_updated_date":"2018-06-15T01:09:21Z","reference_number":"EMEA/HMPC/179282/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-development-community-herbal-monographs-and-inclusion-herbal-substances-preparations-or-combinations-thereof-community-list-calendula-officinalis-l-flos-firs_en.pdf"},
    {"id":"21164","name":"European Medicines Agency recommends revoking authorisations of Caustinerf arsenical and Yranicid arsenical used in dental procedures","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/242277/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/european-medicines-agency-recommends-revoking-authorisations-caustinerf-arsenical-and-yranicid-arsenical-used-dental-procedures_en.pdf"},
    {"id":"21165","name":"CHMP post-authorisation summary of positive opinion for Parareg on 24 April 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/206494/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-parareg-24-april-2008_en.pdf"},
    {"id":"21166","name":"What's new in pharmacovigilance - QPPV Update - Issue 1","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T15:37:00Z","last_updated_date":"2016-04-29T15:37:00Z","reference_number":"Issue 1","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-1_en.pdf"},
    {"id":"21167","name":"European Medicines Agency starts review of orlistat-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-09-22T19:00:00Z","last_updated_date":"2011-09-22T19:00:00Z","reference_number":"EMA/CHMP/771335/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-orlistat-containing-medicines_en.pdf"},
    {"id":"21168","name":"Ketoprofen: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/020/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ketoprofen-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21169","name":"Nicardipine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002149/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T15:11:00Z","last_updated_date":"2017-03-09T18:55:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/nicardipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002149201605_sv.pdf"}},
    {"id":"21170","name":"Presentation - The choice of outcome parameters and need for distinct assessment tools with regard to the different disease stages in Alzheimer's disease - regulator’s perspective (Jens Heisterberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-choice-outcome-parameters-and-need-distinct-assessment-tools-regard-different-disease-stages-alzheimers-disease-regulators-perspective-jens-heisterberg_en.pdf"},
    {"id":"21171","name":"Committee for medicinal products for human use summary of positive opinion for Dafiro HCT","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/471511/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-dafiro-hct_en.pdf"},
    {"id":"21174","name":"Cell culture inactivated influenza vaccines - Annex to note for guidance on harmonisation of requirements for influenza vaccines CPMP/BWP/214/96","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-01-17T01:00:00Z","last_updated_date":"2002-01-17T01:00:00Z","reference_number":"CPMP/BWP/2490/00/Adopted","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/cell-culture-inactivated-influenza-vaccines-annex-note-guidance-harmonisation-requirements-influenza-vaccines-cpmpbwp21496_en.pdf"},
    {"id":"21178","name":"Technetium (99mTc) pertechnetate: List of nationally authorised medicinal - PSUSA/00002866/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T19:12:00Z","last_updated_date":"2016-10-28T19:16:37Z","reference_number":"EMA/719535/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/technetium-99mtc-pertechnetate-list-nationally-authorised-medicinal-psusa00002866201603_en.pdf"},
    {"id":"21179","name":"Questions and answers on recommendation for the refusal of the marketing authorisation for Cayston: International non-proprietary name (INN): aztreonam","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-03-20T00:09:21Z","last_updated_date":"2009-03-20T00:09:21Z","reference_number":"EMEA/154142/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-cayston-international-non-proprietary-name-inn-aztreonam_en.pdf"},
    {"id":"21180","name":"CHMP summary of positive opinion for Vokanamet","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T13:00:00Z","last_updated_date":"2014-04-02T12:10:00Z","reference_number":"EMA/CHMP/90545/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vokanamet_en.pdf"},
    {"id":"21181","name":"Overview of comments received on 'reflection paper on classification of advanced-therapy medicinal products' (EMA/600280/2010)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-17T17:16:00Z","last_updated_date":"2012-12-17T17:16:00Z","reference_number":"EMA/CAT/658287/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-classification-advanced-therapy-medicinal-products-ema6002802010_en.pdf"},
    {"id":"21184","name":"CHMP summary of positive opinion for Movymia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/737990/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-movymia_en.pdf"},
    {"id":"21185","name":"Report on annual workshop of the European network of paediatric research at the European Medicines Agency - 26-27 June 2014","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-02-02T15:00:00Z","last_updated_date":"2015-02-02T15:00:00Z","reference_number":"EMA/500467/2014","document_url":"https://www.ema.europa.eu/en/documents/report/report-annual-workshop-european-network-paediatric-research-european-medicines-agency-26-27-june-2014_en.pdf"},
    {"id":"21188","name":"Presentation - Session 2: Parameters guiding a site/histology - independent drug development (Jan Schellens)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-parameters-guiding-sitehistology-independent-drug-development-jan-schellens_en.pdf"},
    {"id":"21191","name":"Presentation - Workshop on patient’s voice in the evaluation of medicines - Scientific advice/protocol assistance and patient representatives (Kristina Larsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T01:00:00Z","last_updated_date":"2013-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patients-voice-evaluation-medicines-scientific-adviceprotocol-assistance-and-patient-representatives-kristina-larsson_en.pdf"},
    {"id":"21193","name":"European Medicines Agency’s Paediatric Committee: Elects its first chairand vice-chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-09-27T02:00:00Z","last_updated_date":"2007-09-27T02:00:00Z","reference_number":"EMEA/441880/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-paediatric-committee-elects-its-first-chairand-vice-chair_en.pdf"},
    {"id":"21195","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T16:29:00Z","last_updated_date":"2016-03-14T16:29:00Z","reference_number":"EMA/112087/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-february-2016_en.pdf"},
    {"id":"21196","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-28 January 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-02-11T11:20:00Z","last_updated_date":"2015-02-11T11:20:00Z","reference_number":"EMA/HMPC/82378/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-27-28-january-2015_en.pdf"},
    {"id":"21199","name":"ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy questions and answers - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"CPMP/ICH/5551/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-4-e-common-technical-document-registration-pharmaceuticals-human-use-efficacy-questions-and-answers-step-5_en.pdf"},
    {"id":"21201","name":"Evaluation of the safety of veterinary medicinal products for the target animals","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1994-09-01T02:00:00Z","last_updated_date":"1994-09-01T02:00:00Z","reference_number":"7AE2a Volume 7","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/evaluation-safety-veterinary-medicinal-products-target-animals_en.pdf"},
    {"id":"21203","name":"Regulatory questions and answers on herbal medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-22T01:00:00Z","last_updated_date":"2021-08-02T17:00:00Z","reference_number":"EMA/HMPC/345132/2010 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/other/regulatory-questions-and-answers-herbal-medicinal-products_en.pdf"},
    {"id":"21208","name":"CVMP summary of positive opinion for Suvaxyn Circo + MH RTU","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-11T16:00:00Z","last_updated_date":"2015-09-11T16:00:00Z","reference_number":"EMA/CVMP/511548/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-suvaxyn-circo-mh-rtu_en.pdf"},
    {"id":"21209","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - March 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-03-31T02:00:00Z","last_updated_date":"2009-03-31T02:00:00Z","reference_number":"EMEA/202723/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-march-2009_en.pdf"},
    {"id":"21212","name":"Presentation -  Moving neonatology into the modern era of drug development - Overview of potential consortium projects and deliverables (Mark Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-moving-neonatology-modern-era-drug-development-overview-potential-consortium-projects-and-deliverables-mark-turner_en.pdf"},
    {"id":"21213","name":"Mifepristone Article 29(4) referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/mifepristone-article-294-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/mifepristone-article-294-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/mifepristone-article-294-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/mifepristone-article-294-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/mifepristone-article-294-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/mifepristone-article-294-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/mifepristone-article-294-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/mifepristone-article-294-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/mifepristone-article-294-referral-annex-iv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/mifepristone-article-294-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/mifepristone-article-294-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/mifepristone-article-294-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/mifepristone-article-294-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/mifepristone-article-294-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/mifepristone-article-294-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/mifepristone-article-294-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/mifepristone-article-294-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/mifepristone-article-294-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/mifepristone-article-294-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/mifepristone-article-294-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/mifepristone-article-294-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/mifepristone-article-294-referral-annex-iv_sv.pdf"}},
    {"id":"21217","name":"(Superseded) European Surveillance of Veterinary Antimicrobial Consumption  (ESVAC) data collection form (template)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-04-20T02:00:00Z","last_updated_date":"2013-04-18T11:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/superseded-european-surveillance-veterinary-antimicrobial-consumption-esvac-data-collection-form-template_en.xlsx"},
    {"id":"21220","name":"Public declaration of interests and confidentiality undertaking of European\n\nMedicines Agency (EMA) Management Board members, scientific committee\n\nmembers and experts","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-07-18T02:00:00Z","last_updated_date":"2010-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/public-declaration-interests-and-confidentiality-undertaking-european-medicines-agency-ema-management-board-members-scientific-committee-members-and-experts_en.pdf"},
    {"id":"21222","name":"Focetria: Summary of product characteristics","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-05T01:00:00Z","last_updated_date":"2010-03-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/focetria-summary-product-characteristics_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/focetria-summary-product-characteristics_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/focetria-summary-product-characteristics_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/focetria-summary-product-characteristics_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/focetria-summary-product-characteristics_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/focetria-summary-product-characteristics_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/focetria-summary-product-characteristics_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/focetria-summary-product-characteristics_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/focetria-summary-product-characteristics_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/focetria-summary-product-characteristics_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/focetria-summary-product-characteristics_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/focetria-summary-product-characteristics_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/focetria-summary-product-characteristics_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/focetria-summary-product-characteristics_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/focetria-summary-product-characteristics_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/focetria-summary-product-characteristics_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/focetria-summary-product-characteristics_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/focetria-summary-product-characteristics_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/focetria-summary-product-characteristics_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/focetria-summary-product-characteristics_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/focetria-summary-product-characteristics_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/focetria-summary-product-characteristics_sv.pdf"}},
    {"id":"21223","name":"EU/3/12/1079 : Public summary of opinion on orphan designation: Artesunate for the treatment of malaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2013-01-25T12:00:00Z","reference_number":"EMA/COMP/732365/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121079-public-summary-opinion-orphan-designation-artesunate-treatment-malaria_en.pdf"},
    {"id":"21224","name":"Draft guideline on the clinical investigation of human Anti-D immunoglobulin for intravenous and/or intramuscular use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-04-27T02:00:00Z","last_updated_date":"2007-04-27T02:00:00Z","reference_number":"CPMP/BPWG/575/99 Rev. 1 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-human-anti-d-immunoglobulin-intravenous-andor-intramuscular-use_en.pdf"},
    {"id":"21225","name":"EU/3/17/1970: Public summary of opinion on orphan designation: Sirolimus for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-14T01:00:00Z","last_updated_date":"2018-03-14T01:00:00Z","reference_number":"EMA/826628/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171970-public-summary-opinion-orphan-designation-sirolimus-treatment-sickle-cell-disease_en.pdf"},
    {"id":"21227","name":"Questions and answers on Dexamethasone Alapis (dexamethasone, oral solution, 0.4 mg/ml)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T03:00:00Z","last_updated_date":"2012-02-02T02:00:00Z","reference_number":"EMA/CHMP/582483/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-dexamethasone-alapis-dexamethasone-oral-solution-04-mgml_sv.pdf"}},
    {"id":"21229","name":"Sodium dichloroisocyanurate: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sodium-dichloroisocyanurate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21230","name":"Nicola Orlandi (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/nicola-orlandi-doi_en.pdf"},
    {"id":"21232","name":"CHMP summary of positive opinion for Mycamine","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2008-02-21T01:00:00Z","reference_number":"EMEA/CHMP/366318/2007","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mycamine_en.pdf"},
    {"id":"21234","name":"Superseded overview of comments received on Community herbal monograph on Cynara scolymus L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T01:00:00Z","last_updated_date":"2011-12-21T01:00:00Z","reference_number":"EMA/HMPC/350089/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-cynara-scolymus-l-folium_en.pdf"},
    {"id":"21235","name":"The reference manure concept - Robert Kreuzig","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:09:21Z","last_updated_date":"2009-06-23T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/reference-manure-concept-robert-kreuzig_en.pdf"},
    {"id":"21241","name":"Teddy Networking Experience - Prof Adriana Ceci","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/teddy-networking-experience-prof-adriana-ceci_en.pdf"},
    {"id":"21245","name":"Presentation - Reliably basing conclusions on subgroups of clinical trials (Koch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reliably-basing-conclusions-subgroups-clinical-trials-koch_en.pdf"},
    {"id":"21246","name":"Committee on herbal medicinal products (HMPC): Meeting report, 4-5 July 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/HMPC/314187/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-4-5-july-2007_en.pdf"},
    {"id":"21249","name":"How to use the defective product report to notify a quality defect to European Medicines Agency","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T12:00:00Z","last_updated_date":"2018-05-03T12:00:00Z","reference_number":"EMA/INS/GMP/35037/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/how-use-defective-product-report-notify-quality-defect-european-medicines-agency_en.pdf"},
    {"id":"21250","name":"Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 may 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products f...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-25T17:35:00Z","last_updated_date":"2014-07-25T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/regulation-eu-no-6582014-european-parliament-and-council-15-may-2014-fees-payable-european-medicines-agency-conduct-pharmacovigilance-activities-respect-medicinal-products-f_en.pdf"},
    {"id":"21251","name":"Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with finalisation of module XV","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-24T00:00:00Z","last_updated_date":"2013-01-24T00:00:00Z","reference_number":"EMA/34842/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-introductory-cover-note-last-updated-finalisation-module-xv_en.pdf"},
    {"id":"21254","name":"Questions and answers on the review of RotaTeq (rotavirus vaccine, live, oral)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-09-23T02:00:00Z","last_updated_date":"2010-09-23T02:00:00Z","reference_number":"EMA/588405/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-rotateq-rotavirus-vaccine-live-oral_en.pdf"},
    {"id":"21255","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Bavencio (avelumab) for the treatment of Merkel cell carcinoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"EMA/569222/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-bavencio-avelumab-treatment-merkel-cell-carcinoma_en.pdf"},
    {"id":"21257","name":"Questions and answers on Diflucan and associated names (fluconazole, 50, 100, 150 and 200 mg capsules, oral solution 5 mg/ml, powder for oral suspension 10 mg/ml or 40 mg/ml, solution for infusion 2 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    {"id":"21258","name":"EMEA recommends information on lung cancer cases to be included in\n\nExubera product information","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-17T02:00:00Z","last_updated_date":"2008-06-17T02:00:00Z","reference_number":"EMEA/306720/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-information-lung-cancer-cases-be-included-exubera-product-information_en.pdf"},
    {"id":"21259","name":"Overview of comments received on draft revised guideline on the SPC for antimicrobial products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-11-12T00:09:21Z","last_updated_date":"2007-11-12T00:09:21Z","reference_number":"EMEA/CVMP/SAGAM/420018/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-revised-guideline-spc-antimicrobial-products_en.pdf"},
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    {"id":"21261","name":"Summary of the evaluation of the proposed paediatric investigation plan: Apremilast for treatment of Behcet disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/609533/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-apremilast-treatment-behcet-disease_en.pdf"},
    {"id":"21263","name":"Flutiform - Article 29 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T02:00:00Z","last_updated_date":"2012-10-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flutiform-article-29-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flutiform-article-29-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flutiform-article-29-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flutiform-article-29-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flutiform-article-29-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flutiform-article-29-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flutiform-article-29-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flutiform-article-29-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flutiform-article-29-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flutiform-article-29-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flutiform-article-29-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flutiform-article-29-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flutiform-article-29-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flutiform-article-29-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flutiform-article-29-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flutiform-article-29-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flutiform-article-29-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flutiform-article-29-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flutiform-article-29-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flutiform-article-29-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flutiform-article-29-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flutiform-article-29-referral-annex-ii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/flutiform-article-29-referral-annex-ii_is.pdf"}},
    {"id":"21264","name":"Praziquantel: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-09-01T02:00:00Z","last_updated_date":"1996-09-01T02:00:00Z","reference_number":"EMEA/MRL/141/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/praziquantel-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21265","name":"CHMP post-authorisation summary of positive opinion for Reyataz","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-reyataz_en.pdf"},
    {"id":"21266","name":"Inductos Article-20 procedure - Review started","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/491454/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/inductos-article-20-procedure-review-started_en.pdf"},
    {"id":"21268","name":"EU/3/14/1361: Public summary of opinion on orphan designation: 1-(6-Benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T14:00:00Z","last_updated_date":"2020-12-14T14:00:00Z","reference_number":"EMA/COMP/646194/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141361-public-summary-opinion-orphan-designation-1-6-benzothiazolylsulfonyl-5-chloro-1h-indole-2-butanoic-acid-treatment-systemic-sclerosis_en.pdf"},
    {"id":"21269","name":"Questions and answers on the withdrawal of the marketing-authorisation application for Solumarv (human insulin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"EMA/CHMP/761027/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-solumarv-human-insulin_sv.pdf"}},
    {"id":"21270","name":"Carisoprodol - Article 107 procedures - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-15T00:08:21Z","last_updated_date":"2007-11-15T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/carisoprodol-article-107-procedures-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/carisoprodol-article-107-procedures-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/carisoprodol-article-107-procedures-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/carisoprodol-article-107-procedures-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/carisoprodol-article-107-procedures-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/carisoprodol-article-107-procedures-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/carisoprodol-article-107-procedures-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/carisoprodol-article-107-procedures-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/carisoprodol-article-107-procedures-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/carisoprodol-article-107-procedures-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/carisoprodol-article-107-procedures-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/carisoprodol-article-107-procedures-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/carisoprodol-article-107-procedures-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/carisoprodol-article-107-procedures-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/carisoprodol-article-107-procedures-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/carisoprodol-article-107-procedures-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/carisoprodol-article-107-procedures-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/carisoprodol-article-107-procedures-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/carisoprodol-article-107-procedures-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/carisoprodol-article-107-procedures-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/carisoprodol-article-107-procedures-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/carisoprodol-article-107-procedures-annex-iii_sv.pdf"}},
    {"id":"21271","name":"Withdrawal assessment report for Arxxant","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-09-18T02:00:00Z","last_updated_date":"2007-09-18T02:00:00Z","reference_number":"EMEA/150964/2007","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-arxxant_en.pdf"},
    {"id":"21273","name":"Agenda - PRAC draft agenda of meeting 3-6 July 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-07-03T18:30:00Z","last_updated_date":"2017-07-03T18:30:00Z","reference_number":"EMA/PRAC/423016/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-3-6-july-2017_en.pdf"},
    {"id":"21274","name":"Comments received from public consultation on good\n\npharmacovigilance practices: Good pharmacovigilance practices module VI – Management and reporting of adverse reactions to medicinal products (Rev 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-15T13:00:00Z","last_updated_date":"2014-09-15T13:00:00Z","reference_number":"EMA/540396/2014","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-good-pharmacovigilance-practices-module-vi-management-and-reporting-adverse-reactions-medicinal-products-rev-1_en.pdf"},
    {"id":"21275","name":"Norsed Combi D - Article 29 referral - Annex I-III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/norsed-combi-d-article-29-referral-annex-i-iii_sv.pdf"}},
    {"id":"21276","name":"EU/3/07/478: Public summary of positive opinion for orphan designation of N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide for the treatment of Hodgkin's lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2022-05-10T02:00:00Z","reference_number":"EMEA/COMP/389996/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307478-public-summary-positive-opinion-orphan-designation-n-2-amino-phenyl-4-4-pyridin-3-yl-pyrimidin-2-ylamino-methyl-benzamide-treatment-hodgkins-lymphoma_en.pdf"},
    {"id":"21277","name":"CHMP summary of positive opinion for Jevtana","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/26276/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-jevtana_en.pdf"},
    {"id":"21278","name":"Reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-09-17T18:17:00Z","last_updated_date":"2015-09-17T18:17:00Z","reference_number":"EMA/CVMP/IWP/37924/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-heat-treatment-inactivate-endogenous-retroviruses-live-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"21279","name":"Guideline on core SmPC and package leaflet for sodium iodide (131I) for therapeutic use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-03-22T10:35:00Z","last_updated_date":"2018-03-22T10:35:00Z","reference_number":"EMA/CHMP/630248/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-and-package-leaflet-sodium-iodide-131i-therapeutic-use_en.pdf"},
    {"id":"21282","name":"Chloramphenicol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-15T02:00:00Z","last_updated_date":"1996-05-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/chloramphenicol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21283","name":"CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"EMA/CHMP/659472/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-emtricitabinetenofovir-disoproxil-mylan_en.pdf"},
    {"id":"21284","name":"EU paediatric working groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-21T02:09:21Z","last_updated_date":"2009-04-21T02:09:21Z","reference_number":"EMEA/248833/2009","document_url":"https://www.ema.europa.eu/en/documents/other/eu-paediatric-working-groups_en.pdf"},
    {"id":"21286","name":"COMP meeting report on the review of applications for orphan designation: September 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-09-09T15:30:00Z","last_updated_date":"2014-11-18T16:20:00Z","reference_number":"EMA/COMP/449891/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-september-2014_en.pdf"},
    {"id":"21287","name":"Presentation - 2.1 Essential innovation and access to medicines: towards new models of research and development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T12:00:00Z","last_updated_date":"2011-11-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-21-essential-innovation-and-access-medicines-towards-new-models-research-and-development_en.pdf"},
    {"id":"21288","name":"Phoxim: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/509/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phoxim-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21290","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 April 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/CVMP/249719/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-april-2016_en.pdf"},
    {"id":"21292","name":"Presentation - New perception of disability – including cognition, fatigue, pain and other impairments related to multiple sclerosis (Diego Cadavid)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-perception-disability-including-cognition-fatigue-pain-and-other-impairments-related-multiple-sclerosis-diego-cadavid_en.pdf"},
    {"id":"21296","name":"Superseded opinion of the Committee on Herbal Medicinal products on a community herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMEA/HMPC/584717/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"21298","name":"Baxter dialysis solutions Article-31 referral - Annex III (US site)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iii-us-site_sv.pdf"}},
    {"id":"21299","name":"List of participants - Fourth stakeholders forum on the implementation of the new pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T13:00:00Z","last_updated_date":"2012-03-05T13:00:00Z","reference_number":"EMA/100161/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-fourth-stakeholders-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"21300","name":"Draft Community herbal monograph on Barbados aloes (Aloe barbadensis) and cape aloes (Aloe capensis)","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-03-09T01:00:00Z","last_updated_date":"2006-03-09T01:00:00Z","reference_number":"EMEA/HMPC/76310/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-barbados-aloes-aloe-barbadensis-and-cape-aloes-aloe-capensis_en.pdf"},
    {"id":"21302","name":"Presentation - International regulators’ perspectives in handling patient-support programmes and market-research programmes (Junko Sato)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T02:00:00Z","last_updated_date":"2013-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-regulators-perspectives-handling-patient-support-programmes-and-market-research-programmes-junko-sato_en.pdf"},
    {"id":"21304","name":"Annexes - 2015 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2016-05-17T18:00:00Z","last_updated_date":"2016-05-27T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annexes-2015-annual-report-european-medicines-agency_en.pdf"},
    {"id":"21305","name":"European Medicines Agency process for engaging in externally funded regulatory sciences and process improvement research activities for public and animal health","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-15T18:25:00Z","last_updated_date":"2019-03-07T14:42:00Z","reference_number":"EMA/158095/2019","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-process-engaging-externally-funded-regulatory-sciences-and-process-improvement-research-activities-public-and-animal-health_en.pdf"},
    {"id":"21307","name":"Public statement on possible interaction between clopidogrel and proton pump inhibitors","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:09:21Z","last_updated_date":"2009-05-29T02:09:21Z","reference_number":"EMEA/328956/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-possible-interaction-between-clopidogrel-and-proton-pump-inhibitors_en.pdf"},
    {"id":"21308","name":"CHMP authorisation positive summary of opinion for Arixtra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2010-07-23T02:00:00Z","reference_number":"EMA/CHMP/429539/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-authorisation-positive-summary-opinion-arixtra_en.pdf"},
    {"id":"21310","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 October 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-10-09T02:00:00Z","last_updated_date":"2015-10-09T02:00:00Z","reference_number":"EMA/CVMP/646412/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-october-2015_en.pdf"},
    {"id":"21311","name":"Workshop proceedings - Transatlantic workshop on drug-related progressive multifocal leukoencephalopathy (PML)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-09-08T11:50:00Z","last_updated_date":"2011-09-08T17:29:00Z","reference_number":"EMA/674403/2011","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-proceedings-transatlantic-workshop-drug-related-progressive-multifocal-leukoencephalopathy-pml_en.pdf"},
    {"id":"21312","name":"Guideline on clinical investigation of medicinal products used in weight control","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-15T01:00:00Z","last_updated_date":"2007-11-15T01:00:00Z","reference_number":"CPMP/EWP/281/96 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-used-weight-control_en.pdf"},
    {"id":"21315","name":"Minutes - EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"EMA/779124/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"21316","name":"Pharmacovigilance","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2015-05-18T18:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/pharmacovigilance_en.pdf"},
    {"id":"21317","name":"Presentation - Core data set: CYP2D6 metabolism","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-core-data-set-cyp2d6-metabolism_en.pdf"},
    {"id":"21318","name":"Presentation - EURO-NMD case study (Teresinha Evangelista)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-euro-nmd-case-study-teresinha-evangelista_en.pdf"},
    {"id":"21323","name":"eCTD/Non eCTD electronic Submission (Nees): Impact on the centralised procedure Claire Holmes","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ectdnon-ectd-electronic-submission-nees-impact-centralised-procedure-claire-holmes_en.pdf"},
    {"id":"21325","name":"Equimectin - Article 33 Referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-16T00:59:00Z","last_updated_date":"2007-11-16T00:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/equimectin-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"21329","name":"Hydroxycarbamide: List of nationally authorised medicinal products - PSUSA/00009182/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-31T15:15:00Z","last_updated_date":"2018-08-31T15:23:25Z","reference_number":"EMA/584534/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxycarbamide-list-nationally-authorised-medicinal-products-psusa00009182201712_en.pdf"},
    {"id":"21331","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 15-17 January 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T14:40:00Z","last_updated_date":"2014-01-24T14:40:00Z","reference_number":"EMA/PDCO/799206/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-15-17-january-2014_en.pdf"},
    {"id":"21332","name":"Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T02:00:00Z","last_updated_date":"2016-10-18T15:41:15Z","reference_number":"EMA/626602/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/celecoxib-list-nationally-authorised-medicinal-products-psusa00000616201412_en.pdf"},
    {"id":"21334","name":"Committee for Medicinal Products for Human Use (CHMP) - February 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-03-03T01:00:00Z","last_updated_date":"2003-03-03T01:00:00Z","reference_number":"EMEA/CPMP/3794/03/corr","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-february-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"21335","name":"Typhoid vaccine (live, attenuated): List of nationally authorised medicinal products - PSUSA/00003067/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-22T17:00:00Z","last_updated_date":"2018-03-22T17:00:00Z","reference_number":"EMA/182704/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/typhoid-vaccine-live-attenuated-list-nationally-authorised-medicinal-products-psusa00003067201707_en.pdf"},
    {"id":"21338","name":"EU/3/14/1261: Public summary of opinion on orphan designation: Caffeine citrate for the prevention of bronchopulmonary dysplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-06-05T02:00:00Z","last_updated_date":"2014-06-05T02:00:00Z","reference_number":"EMA/COMP/89532/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141261-public-summary-opinion-orphan-designation-caffeine-citrate-prevention-bronchopulmonary-dysplasia_en.pdf"},
    {"id":"21339","name":"Presentation - Information to patients","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-patients_en.pdf"},
    {"id":"21341","name":"EU/3/10/767: Public summary of opinion on orphan designation: 11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene for the treat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMA/COMP/360315/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310767-public-summary-opinion-orphan-designation-11-2-pyrrolidin-1-yl-ethoxy-1419-dioxa-5726-triaza-tetracyclo19311261812-heptacosa-125226358101227162123-decaene-treat_en.pdf"},
    {"id":"21342","name":"CTAG2: Clinical Trial Advisory Group on clinical-trial-data formats - Membership overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag2-clinical-trial-advisory-group-clinical-trial-data-formats-membership-overview_en.pdf"},
    {"id":"21343","name":"Public Statement on Docetaxel Teva Pharma: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-01-21T01:00:00Z","last_updated_date":"2014-01-21T01:00:00Z","reference_number":"EMA/784577/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-docetaxel-teva-pharma-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"21344","name":"Cefepime: List of nationally authorised medicinal products - PSUSA/00000593/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-10-18T15:41:08Z","reference_number":"EMA/187078/2016187078/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefepime-list-nationally-authorised-medicinal-products-psusa00000593201506_en.pdf"},
    {"id":"21345","name":"Note for guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-12-16T01:00:00Z","last_updated_date":"1999-12-16T01:00:00Z","reference_number":"CPMP/EWP/563/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-venous-thromboembolic-disease_en.pdf"},
    {"id":"21346","name":"Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-13T17:38:00Z","last_updated_date":"2018-08-13T17:44:01Z","reference_number":"EMA/PRAC/384956/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/atorvastatin-list-nationally-authorised-medicinal-products-psusa00010347201710_en.pdf"},
    {"id":"21347","name":"Questions and answers on the CVMP positive opinions for avian influenza vaccines for use in birds","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-07-21T02:00:00Z","last_updated_date":"2006-07-21T02:00:00Z","reference_number":"EMEA/281078/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-cvmp-positive-opinions-avian-influenza-vaccines-use-birds_en.pdf"},
    {"id":"21349","name":"Everolimus (indicated for rejection of transplanted organs): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00010269/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-13T02:00:00Z","last_updated_date":"2016-10-18T14:02:17Z","reference_number":"EMA/333075/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/everolimus-indicated-rejection-transplanted-organs-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010269201507_en.pdf"},
    {"id":"21351","name":"EU/3/07/439: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class for the treatment of cryopirin-associated periodic syndromes (Familial Cold  Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS)...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-08T02:00:00Z","last_updated_date":"2015-02-12T01:00:00Z","reference_number":"EMEA/COMP/104059/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307439-recombinant-human-monoclonal-antibody-human-il-1beta-igg1k-class-treatment-cryopirin-associated-periodic-syndromes-familial-cold-urticaria-syndrome-fcus-muckle-wells-syndrome-mws_en.pdf"},
    {"id":"21353","name":"Annual accounts: Financial year 2009","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/401405/2010","document_url":"https://www.ema.europa.eu/en/documents/report/annual-accounts-financial-year-2009_en.pdf"},
    {"id":"21354","name":"Final assessment report on Ginkgo biloba L., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-04-08T02:00:00Z","last_updated_date":"2015-04-08T02:00:00Z","reference_number":"EMA/HMPC/321095/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-ginkgo-biloba-l-folium_en.pdf"},
    {"id":"21355","name":"Presentation - Pharmacovigilance in the elderly: Conclusions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-elderly-conclusions_en.pdf"},
    {"id":"21357","name":"Committee on herbal medicinal products (HMPC): Meeting report, 15-16 July 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-21T02:00:00Z","last_updated_date":"2009-07-21T02:00:00Z","reference_number":"EMEA/HMPC/466806/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-15-16-july-2009_en.pdf"},
    {"id":"21362","name":"Public statement on Clopidogrel Sandoz: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2011-10-26T13:45:00Z","last_updated_date":"2011-10-26T13:45:00Z","reference_number":"EMA/812850/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-sandoz-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"21363","name":"Concept paper on the development of a quality guideline on pharmaceutical development of medicines for paediatric use","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/138931/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-quality-guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf"},
    {"id":"21364","name":"Colour change for insulin injection Fiasp to avoid mix ups with Tresiba","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2018-03-23T13:00:00Z","reference_number":"EMA/166410/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/colour-change-insulin-injection-fiasp-avoid-mix-ups-tresiba_en.pdf"},
    {"id":"21366","name":"Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Search strategies for 50 top chemical substance groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-30T14:00:00Z","last_updated_date":"2015-06-30T14:00:00Z","reference_number":"EMA/403865/2015","document_url":"https://www.ema.europa.eu/en/documents/other/monitoring-medical-literature-and-entry-relevant-information-eudravigilance-database-european-medicines-agency-search-strategies-50-top-chemical-substance-groups_en.pdf"},
    {"id":"21367","name":"Restrictions on use of codeine for pain relief in children – CMDh endorses PRAC recommendation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/385716/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/restrictions-use-codeine-pain-relief-children-cmdh-endorses-prac-recommendation_en.pdf"},
    {"id":"21368","name":"Community herbal monograph on Cinnamomum verum J.S. Presl, cortex","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2011-08-05T02:00:00Z","reference_number":"EMA/HMPC/246774/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/community-herbal-monograph-cinnamomum-verum-js-presl-cortex_en.pdf"},
    {"id":"21369","name":"Presentation - Inspection of cross contamination controls in shared facilities (G. McKilligan, MHRA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-inspection-cross-contamination-controls-shared-facilities-g-mckilligan-mhra_en.pdf"},
    {"id":"21371","name":"Withdrawal assessment report for Lenalidomide Celgene Europe","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-08-01T02:00:00Z","last_updated_date":"2008-08-01T02:00:00Z","reference_number":"EMEA/CHMP/249329/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-lenalidomide-celgene-europe_en.pdf"},
    {"id":"21373","name":"EU/3/14/1362: Public summary of opinion on orphan designation: 1-(6-Benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T14:00:00Z","last_updated_date":"2015-01-15T14:00:00Z","reference_number":"EMA/COMP/646696/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141362-public-summary-opinion-orphan-designation-1-6-benzothiazolylsulfonyl-5-chloro-1h-indole-2-butanoic-acid-treatment-systemic-sclerosis_en.pdf"},
    {"id":"21375","name":"Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-01-24T16:30:00Z","last_updated_date":"2018-01-24T16:30:00Z","reference_number":"EMA/CHMP/CVMP/3Rs/94436/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidance-individual-laboratories-transfer-quality-control-methods-validated-collaborative-trials-view-implementing-3rs_en.pdf"},
    {"id":"21376","name":"Committee for Medicinal Products for Human Use (CHMP) - June 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-07-04T02:00:00Z","last_updated_date":"2003-07-04T02:00:00Z","reference_number":"EMEA/CPMP/3297/03","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-june-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"21377","name":"Biomarkers and clinical trials, Dr Patricia Woo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/biomarkers-and-clinical-trials-dr-patricia-woo_en.pdf"},
    {"id":"21380","name":"Tetrazepam-containing medicines - Article-107i procedure - PRAC list of questions to be addressed by the marketing-authorisation holders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T13:00:00Z","last_updated_date":"2013-01-11T13:00:00Z","reference_number":"EMA/PRAC/15160/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-prac-list-questions-be-addressed-marketing-authorisation-holders_en.pdf"},
    {"id":"21381","name":"EMA review of Zinbryta confirms medicine’s risks outweigh its benefits","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-05-18T14:00:00Z","last_updated_date":"2018-05-18T14:00:00Z","reference_number":"EMA/286850/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_en.pdf"},
    {"id":"21384","name":"Guidance on format of the risk-management plan in the European Union part II: Module SIV - Populations not studied in clinical trials","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2013-08-21T18:35:00Z","reference_number":"EMA/465927/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-siv-populations-not-studied-clinical-trials_en.pdf"},
    {"id":"21387","name":"EMEA announces composition of its scientific committees","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/15150/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-announces-composition-its-scientific-committees_en.pdf"},
    {"id":"21388","name":"Report - Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-11-21T11:12:00Z","last_updated_date":"2017-11-21T11:12:00Z","reference_number":"EMA/686513/2017","document_url":"https://www.ema.europa.eu/en/documents/report/report-industry-stakeholder-teleconference-brexit-and-operation-centralised-procedure-veterinary-medicinal-products_en.pdf"},
    {"id":"21390","name":"Mandate, objectives and rules of procedure for the Summary of Product Characteristics (SmPC) Advisory Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-08T01:00:00Z","last_updated_date":"2013-01-08T01:00:00Z","reference_number":"EMA/125968/2009","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-summary-product-characteristics-smpc-advisory-group_en.pdf"},
    {"id":"21391","name":"Withdrawal  letter: Firazyr (icatibant)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/95900/2014 ","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-firazyr-icatibant_en.pdf"},
    {"id":"21393","name":"Pharm Research Associates (UK) Ltd withdraws marketing authorisation application for Surfaxin","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-06-08T02:00:00Z","last_updated_date":"2006-06-08T02:00:00Z","reference_number":"EMEA/211505/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/pharm-research-associates-uk-ltd-withdraws-marketing-authorisation-application-surfaxin_en.pdf"},
    {"id":"21396","name":"Presentation - Dose regimen selection for biologics in IBD (Christine Hon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-regimen-selection-biologics-ibd-christine-hon_en.pdf"},
    {"id":"21397","name":"EU/3/12/1002: Public summary of opinion on orphan designation: Adenovirus-associated vector containing human Fas-c gene for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2022-09-26T17:00:00Z","reference_number":"EMA/COMP/268035/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121002-public-summary-opinion-orphan-designation-adenovirus-associated-vector-containing-human-fas-c-gene-treatment-glioma_en.pdf"},
    {"id":"21398","name":"Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T15:00:00Z","last_updated_date":"2017-02-02T15:09:00Z","reference_number":"EMA/77613/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-topical-use-list-nationally-authorised-medicinal-products-psusa00010376201604_en.pdf"},
    {"id":"21400","name":"Summary of the work programme for the European Medicines Agency 2008","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2008-03-28T00:09:21Z","last_updated_date":"2008-03-28T00:09:21Z","reference_number":"EMEA/MB/556125/2007","document_url":"https://www.ema.europa.eu/en/documents/work-programme/summary-work-programme-european-medicines-agency-2008_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/work-programme/summary-work-programme-european-medicines-agency-2008_bg.pdf","es":"https://www.ema.europa.eu/es/documents/work-programme/summary-work-programme-european-medicines-agency-2008_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/work-programme/summary-work-programme-european-medicines-agency-2008_cs.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/summary-work-programme-european-medicines-agency-2008_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/summary-work-programme-european-medicines-agency-2008_de.pdf","et":"https://www.ema.europa.eu/et/documents/work-programme/summary-work-programme-european-medicines-agency-2008_et.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/summary-work-programme-european-medicines-agency-2008_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/summary-work-programme-european-medicines-agency-2008_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/summary-work-programme-european-medicines-agency-2008_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/work-programme/summary-work-programme-european-medicines-agency-2008_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/work-programme/summary-work-programme-european-medicines-agency-2008_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/work-programme/summary-work-programme-european-medicines-agency-2008_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/work-programme/summary-work-programme-european-medicines-agency-2008_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/summary-work-programme-european-medicines-agency-2008_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/work-programme/summary-work-programme-european-medicines-agency-2008_pl.pdf","ro":"https://www.ema.europa.eu/ro/documents/work-programme/summary-work-programme-european-medicines-agency-2008_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/work-programme/summary-work-programme-european-medicines-agency-2008_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/work-programme/summary-work-programme-european-medicines-agency-2008_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/summary-work-programme-european-medicines-agency-2008_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/summary-work-programme-european-medicines-agency-2008_sv.pdf"}},
    {"id":"21401","name":"Public summary of the evaluation of the proposed paediatric investigation plan: N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine for treatment of anaemia due to chronic disorders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T12:10:00Z","last_updated_date":"2014-10-21T12:10:00Z","reference_number":"EMA/317118/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-n-13-dicyclohexyl-6-hydroxy-24-dioxo-1234-tetrahydro-5-pyrimidinylcarbonylglycine-treatment-anaemia-due-chronic-disorders_en.pdf"},
    {"id":"21404","name":"Reflection paper: Non-clinical and clinical development of similar medicinal products containing recombinant Interferon Alfa","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/BMWP/102046/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-non-clinical-and-clinical-development-similar-medicinal-products-containing-recombinant-interferon-alfa_en.pdf"},
    {"id":"21405","name":"Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-11-28T11:00:00Z","last_updated_date":"2020-03-19T14:30:00Z","reference_number":"EMA/478309/2017 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-guidance-procedures-related-brexit-medicinal-products-human-and-veterinary-use-within-framework-centralised-procedure_en.pdf"},
    {"id":"21406","name":"CVMP post-authorisation summary of positive opinion for Metacam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-12-11T00:09:21Z","last_updated_date":"2009-12-11T00:09:21Z","reference_number":"EMA/CVMP/802307/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam_en.pdf-4"},
    {"id":"21408","name":"Report from CAT interested parties focus group on non-clinical development of advanced-therapy medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-12-18T13:15:00Z","last_updated_date":"2012-12-18T13:15:00Z","reference_number":"EMA/CAT/716942/2012","document_url":"https://www.ema.europa.eu/en/documents/report/report-cat-interested-parties-focus-group-non-clinical-development-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"21409","name":"Implementation of European Medicines Agency policy on publication of clinical data: status report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/MB/614812/2015","document_url":"https://www.ema.europa.eu/en/documents/report/implementation-european-medicines-agency-policy-publication-clinical-data-status-report_en.pdf"},
    {"id":"21411","name":"Points to consider on xenogeneic cell therapy medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2003-12-17T01:00:00Z","last_updated_date":"2003-12-17T01:00:00Z","reference_number":"CPMP/1199/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-xenogeneic-cell-therapy-medicinal-products_en.pdf"},
    {"id":"21413","name":"Presentation - Referral procedures (A. Marcal, H. Matos and V. Seguin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-referral-procedures-marcal-h-matos-and-v-seguin_en.pdf"},
    {"id":"21414","name":"Flupirtine-containing medicines Article-107i procedure - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T14:00:00Z","last_updated_date":"2013-07-18T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-ii_sv.pdf"}},
    {"id":"21415","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 04-06 October 2016","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T17:00:00Z","last_updated_date":"2016-10-07T17:00:00Z","reference_number":"EMA/CVMP/626867/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-04-06-october-2016_en.pdf"},
    {"id":"21416","name":"National Experience on collection and analysis of data on AM sales and use - Vibeke Frà¸kjà¦r Jensen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/national-experience-collection-and-analysis-data-am-sales-and-use-vibeke-frakjar-jensen_en.pdf"},
    {"id":"21417","name":"Flupirtine Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMEA/H/A-31/1458","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-notification_en.pdf"},
    {"id":"21418","name":"EU/3/10/773: Public summary of opinion on orphan designation: Allogeneic T cells encoding an exogenous TK gene for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2010-10-18T02:00:00Z","reference_number":"EMA/COMP/395841/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310773-public-summary-opinion-orphan-designation-allogeneic-t-cells-encoding-exogenous-tk-gene-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"21420","name":"CHMP summary of opinion for Kanuma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/359213/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-kanuma_en.pdf"},
    {"id":"21423","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Viable autologous adipose-derived regenerative cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:59:00Z","last_updated_date":"2018-01-03T14:59:00Z","reference_number":"EMA/699357/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-viable-autologous-adipose-derived-regenerative-cells_en.pdf"},
    {"id":"21427","name":"EU/3/16/1671: Public summary of opinion on orphan designation: C2'-O-(2-Methoxyethyl) phosphorothioate antisense oligonucleotide targeting the growth hormone receptor for the treatment of acromegaly","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/380897/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161671-public-summary-opinion-orphan-designation-c2-o-2-methoxyethyl-phosphorothioate-antisense-oligonucleotide-targeting-growth-hormone-receptor-treatment-acromegaly_en.pdf"},
    {"id":"21428","name":"Guideline for the testing and evaluation of the efficacy of antiparastic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-11-07T01:00:00Z","last_updated_date":"2000-11-07T01:00:00Z","reference_number":"EMEA/CVMP/005/00-Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-testing-and-evaluation-efficacy-antiparastic-substances-treatment-and-prevention-tick-and-flea-infestation-dogs-and-cats-revision-1_en.pdf"},
    {"id":"21429","name":"Terms of reference 2016 - 2017: ESVAC species Expert Advisory Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-30T17:00:00Z","last_updated_date":"2017-05-30T17:00:00Z","reference_number":"EMA/196621/2015","document_url":"https://www.ema.europa.eu/en/documents/other/terms-reference-2016-2017-esvac-species-expert-advisory-group_en.pdf"},
    {"id":"21434","name":"European Medicines Agency recommends new contraindication for Fareston (toremifene)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T00:09:21Z","last_updated_date":"2009-01-23T00:09:21Z","reference_number":"EMEA/27603/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-new-contraindication-fareston-toremifene_en.pdf"},
    {"id":"21435","name":"European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-06-16T15:30:00Z","last_updated_date":"2017-06-16T15:30:00Z","reference_number":"EMA/260003/2016","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencys-interaction-patients-consumers-healthcare-professionals-and-their-organisations-annual-report-2016_en.pdf"},
    {"id":"21437","name":"CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - First draft with comments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag4-advice-european-medicines-agency-clinical-trial-advisory-group-good-analysis-practice-first-draft-comments_en.pdf"},
    {"id":"21438","name":"Presentation - Key elements of the review of veterinary legislation (David Mackay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-elements-review-veterinary-legislation-david-mackay_en.pdf"},
    {"id":"21439","name":"SGLT2 inhibitors Article-20 procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-article-20-procedure-annex-iii_en.pdf"},
    {"id":"21440","name":"Overview of comments received on draft guideline on the evaluation of medicinal products in the treatment of primary osteoporosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-11-16T01:00:00Z","last_updated_date":"2006-11-16T01:00:00Z","reference_number":"EMEA/CHMP/EWP/433354/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-evaluation-medicinal-products-treatment-primary-osteoporosis_en.pdf"},
    {"id":"21445","name":"Declaration of interests: Henri Meyer","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-henri-meyer_en.pdf"},
    {"id":"21446","name":"CHMP post authorisation positive summary of opinion for Kepivance","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-positive-summary-opinion-kepivance_en.pdf"},
    {"id":"21449","name":"Overview of comments received on 'Committee for Medicinal Products for Human Use position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-28T02:00:00Z","last_updated_date":"2011-06-28T02:00:00Z","reference_number":"EMA/CHMP/BWP/782508/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-committee-medicinal-products-human-use-position-statement-creutzfeldt-jakob-disease-and-plasma-derived-and-urine-derived-medicinal-products_en.pdf"},
    {"id":"21450","name":"Key milestones of European Medicines Agency interactions with patients and consumers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-18T10:00:00Z","last_updated_date":"2015-03-18T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/key-milestones-european-medicines-agency-interactions-patients-and-consumers_en.pdf"},
    {"id":"21451","name":"Scientific recommendation on classification of advanced therapy medicinal products: Suspension of autologous expanded viable chondrocytes embedded in a cross linked hydrogel","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T12:45:00Z","last_updated_date":"2016-04-12T12:45:00Z","reference_number":"EMA/213716/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-suspension-autologous-expanded-viable-chondrocytes-embedded-cross-linked-hydrogel_en.pdf"},
    {"id":"21454","name":"EudraVigilance Operational Plan - milestones 2018 to 2020","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-06-08T19:00:00Z","last_updated_date":"2018-06-08T19:00:00Z","reference_number":"EMA/100194/2018","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-operational-plan-milestones-2018-2020_en.pdf"},
    {"id":"21456","name":"Guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-07-19T13:15:00Z","last_updated_date":"2013-07-19T13:15:00Z","reference_number":"CPMP/EWP/18/01/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-urinary-incontinence_en.pdf"},
    {"id":"21457","name":"Registration form - 2016 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-04-14T02:00:00Z","last_updated_date":"2016-04-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-2016-annual-workshop-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"21458","name":"Session Report: Pharmacovigilance","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-11-28T00:09:21Z","last_updated_date":"2008-11-28T00:09:21Z","reference_number":"EMEA/640479/2008","document_url":"https://www.ema.europa.eu/en/documents/report/session-report-pharmacovigilance_en.pdf"},
    {"id":"21460","name":"Presentation - One size doesn’t fit all - Why it should be different guidances (B. Boulanger, EFSPI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-one-size-doesnt-fit-all-why-it-should-be-different-guidances-b-boulanger-efspi_en.pdf"},
    {"id":"21461","name":"EU/3/12/998: Public summary of opinion on orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene for the treatment of Wiskott-Aldrich syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2015-03-11T16:00:00Z","reference_number":"EMA/COMP/278945/2012 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312998-public-summary-opinion-orphan-designation-autologous-cd34-cells-transfected-lentiviral-vector-containing-wiskott-aldrich-syndrome-protein-gene-treatment-wiskott-aldrich-syndrome_en.pdf"},
    {"id":"21463","name":"Organisational matters - CHMP meeting 22-25 June 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-07-02T12:15:00Z","last_updated_date":"2015-07-02T12:15:00Z","reference_number":"EMA/28021/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-22-25-june-2015_en.pdf"},
    {"id":"21464","name":"Overview of comments received on draft guideline on pharmaceutical fixed combination products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-12-18T01:00:00Z","last_updated_date":"2006-12-18T01:00:00Z","reference_number":"EMEA/CVMP/463526/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-pharmaceutical-fixed-combination-products_en.pdf"},
    {"id":"21465","name":"Announcement of European Medicines Agency priorities for adverse drug reaction research","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-08-04T02:00:00Z","last_updated_date":"2009-08-04T02:00:00Z","reference_number":"EMEA/497624/2009","document_url":"https://www.ema.europa.eu/en/documents/other/announcement-european-medicines-agency-priorities-adverse-drug-reaction-research_en.pdf"},
    {"id":"21466","name":"Guidance on collection and provision of national data on antimicrobial use by animal species/categories","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-24T17:30:00Z","last_updated_date":"2018-02-23T15:07:00Z","reference_number":"EMA/489035/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidance-collection-and-provision-national-data-antimicrobial-use-animal-speciescategories_en.pdf"},
    {"id":"21468","name":"EU/3/13/1124: Public summary of opinion on orphan designation: 2-Hydroxypropyl-β-cyclodextrin for the treatment of Niemann-Pick disease, type C","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-05-14T13:30:00Z","last_updated_date":"2015-03-25T12:30:00Z","reference_number":"EMA/COMP/189520/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131124-public-summary-opinion-orphan-designation-2-hydroxypropyl-i2-cyclodextrin-treatment-niemann-pick-disease-type-c_en.pdf"},
    {"id":"21470","name":"Committee on herbal medicinal products (HMPC): Meeting report, 13-14 May 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-06-05T02:00:00Z","last_updated_date":"2009-06-05T02:00:00Z","reference_number":"EMEA/HMPC/332964/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-13-14-may-2009_en.pdf"},
    {"id":"21472","name":"Guideline on clinical investigation of medicinal products for the treatment of rheumatoid arthritis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-01-10T12:24:00Z","last_updated_date":"2018-01-10T12:24:00Z","reference_number":"CPMP/EWP/556/95 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-rheumatoid-arthritis_en.pdf"},
    {"id":"21473","name":"Response to the European Medicines Agency list of issues - In vitro hollow-fibre-system model of tuberculosis (HFS-TB)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-18T15:00:00Z","last_updated_date":"2014-11-18T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/response-european-medicines-agency-list-issues-vitro-hollow-fibre-system-model-tuberculosis-hfs-tb_en.pdf"},
    {"id":"21476","name":"Questions and answers on recommendation for the refusal of the marketing authorisation for Ramelteon","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T02:09:21Z","last_updated_date":"2008-06-02T02:09:21Z","reference_number":"EMEA/CHMP/268216/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-ramelteon_en.pdf"},
    {"id":"21478","name":"Questions and answers on the withdrawal of the marketing authorisation application for Zafiride (NGR-human tumour necrosis factor alpha)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"EMA/393395/2017","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zafiride-ngr-human-tumour-necrosis-factor-alpha_sv.pdf"}},
    {"id":"21479","name":"Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-03-27T11:00:00Z","last_updated_date":"2017-10-11T14:00:00Z","reference_number":"EMA/CHMP/51230/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-systemic-lupus-erythematosus-and-lupus-nephritis_en.pdf"},
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    {"id":"21484","name":"Withdrawal letter: Raligize","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-raligize_en.pdf"},
    {"id":"21487","name":"Scientific recommendation on classification of advanced therapy medicinal products: bone marrow-derived autologous non-hematopoietic stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T12:35:00Z","last_updated_date":"2016-04-19T12:35:00Z","reference_number":"EMA/264542/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-bone-marrow-derived-autologous-non-hematopoietic-stem-cells_en.pdf-1"},
    {"id":"21488","name":"Draft guideline on stability testing: Stability testing of existing active substances and related finished products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-10-12T02:00:00Z","last_updated_date":"2007-10-12T02:00:00Z","reference_number":"EMEA/CVMP/QWP/846/99-Rev.1 CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-stability-testing-stability-testing-existing-active-substances-and-related-finished-products-revision-1_en.pdf"},
    {"id":"21491","name":"Transfer of appropriations to allow for implementation of simplified information- and communication-technology budget structure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-18T19:00:00Z","last_updated_date":"2013-06-18T19:00:00Z","reference_number":"EMA/MB/273259/2013","document_url":"https://www.ema.europa.eu/en/documents/other/transfer-appropriations-allow-implementation-simplified-information-and-communication-technology-budget-structure_en.pdf"},
    {"id":"21492","name":"EU/3/16/1751: Public summary of positive opinion for orphan designation of fenretinide for the treatment of peripheral T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2022-01-19T01:00:00Z","reference_number":"EMA/622420/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161751-public-summary-positive-opinion-orphan-designation-fenretinide-treatment-peripheral-t-cell-lymphoma_en.pdf"},
    {"id":"21493","name":"Reflection paper on immune-tolerance induction in haemophilia-A patients with inhibitors","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-03-26T13:10:05Z","last_updated_date":"2013-03-26T13:10:05Z","reference_number":"EMA/CHMP/BPWP/153137/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-immune-tolerance-induction-haemophilia-patients-inhibitors_en.pdf"},
    {"id":"21494","name":"Draft Assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2009-05-14T02:09:21Z","reference_number":"EMEA/HMPC/215214/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos_en.pdf"},
    {"id":"21496","name":"Calcium carbonate / famotidine / magnesium hydroxide: List of nationally authorised medicinal products  - PSUSA/00001351/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-12T15:46:00Z","last_updated_date":"2018-07-12T16:01:25Z","reference_number":"EMA/471694/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-carbonate-famotidine-magnesium-hydroxide-list-nationally-authorised-medicinal-products-psusa00001351201709_en.pdf"},
    {"id":"21498","name":"Presentation - European Medicines Agency initiatives on product shortages due to manufacturing/GMP issues (Brendan Cuddy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-initiatives-product-shortages-due-manufacturinggmp-issues-brendan-cuddy_en.pdf"},
    {"id":"21499","name":"Opinion of the HMPC on a Community herbal monograph on Cucurbita pepo L, semen","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/742266/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"21500","name":"Overview of comments received on draft guideline on clinical investigation of medicinal products for the treatment of migraine","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"EMEA/CHMP/EWP/21477/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-treatment-migraine_en.pdf"},
    {"id":"21501","name":"Update report on the Agency’s implementation of EU Telematics strategy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/MB/739297/2010","document_url":"https://www.ema.europa.eu/en/documents/report/update-report-agencys-implementation-eu-telematics-strategy_en.pdf"},
    {"id":"21503","name":"List of participants of the European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ organisations (PCWP) meeting with all eligible organisations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"EMA/702226/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"21504","name":"Merisone Article-29(4) referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-07-28T14:00:00Z","reference_number":"EMEA/H/A-29/1411, EMEA/H/A-29/1412","document_url":"https://www.ema.europa.eu/en/documents/referral/merisone-article-294-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/merisone-article-294-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/merisone-article-294-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/merisone-article-294-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/merisone-article-294-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/merisone-article-294-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/merisone-article-294-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/merisone-article-294-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/merisone-article-294-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/merisone-article-294-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/merisone-article-294-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/merisone-article-294-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/merisone-article-294-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/merisone-article-294-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/merisone-article-294-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/merisone-article-294-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/merisone-article-294-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/merisone-article-294-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/merisone-article-294-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/merisone-article-294-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/merisone-article-294-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/merisone-article-294-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/merisone-article-294-referral-annex-iii_sv.pdf"}},
    {"id":"21505","name":"Final public statement on Tilia tomentosa Moench, flos","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2012-07-09T18:50:00Z","last_updated_date":"2012-07-09T18:50:00Z","reference_number":"EMA/HMPC/510064/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-tilia-tomentosa-moench-flos_en.pdf"},
    {"id":"21506","name":"Annual report of the European Medicines Agency 2009","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2010-05-19T03:00:00Z","last_updated_date":"2010-05-19T03:00:00Z","reference_number":"EMA/MB/69923/2010","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2009_en.pdf"},
    {"id":"21507","name":"Call for submission of scientific data relating to the assessment of Vitis viniferae folium Vitis vinifera L., folium","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2008-06-16T02:09:21Z","last_updated_date":"2008-06-16T02:09:21Z","reference_number":"EMEA/HMPC/245028/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-vitis-viniferae-folium-vitis-vinifera-l-folium_en.pdf"},
    {"id":"21510","name":"Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Re...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-08-08T17:00:00Z","last_updated_date":"2016-08-08T17:00:00Z","reference_number":"EMA/710507/2015","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-module-viii-addendum-i-requirements-transmission-information-non-interventional-post-authorisation-safety-studies-re_en.pdf"},
    {"id":"21511","name":"Decision determining the start date of the term of office of the members of the Management Board appointed by Council Decision No 2013/33/EU","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/MB/82143/2013","document_url":"https://www.ema.europa.eu/en/documents/other/decision-determining-start-date-term-office-members-management-board-appointed-council-decision-no-201333eu_en.pdf"},
    {"id":"21512","name":"First EMEA workshop on ethics in clinical trials - Use of placebo in clinical trials","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-12-04T00:09:21Z","last_updated_date":"2001-12-04T00:09:21Z","reference_number":"EMEA/32158/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-emea-workshop-ethics-clinical-trials-use-placebo-clinical-trials_en.pdf"},
    {"id":"21513","name":"Superseded community herbal monograph on Hypericum perforatum L., herba (well-established medicinal use)","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2009-12-21T00:09:00Z","last_updated_date":"2023-02-22T00:09:00Z","reference_number":"EMA/HMPC/101304/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-hypericum-perforatum-l-herba-well-established-medicinal-use_en.pdf"},
    {"id":"21514","name":"Paracetamol Article-31 referral - Modified-release paracetamol-containing products to be suspended from EU market","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-01T01:00:00Z","last_updated_date":"2018-03-01T01:00:00Z","reference_number":"EMA/118413/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/paracetamol-article-31-referral-modified-release-paracetamol-containing-products-be-suspended-eu-market_sv.pdf"}},
    {"id":"21515","name":"Overview of comments received on 'draft telithromycin product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116814/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-telithromycin-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"21516","name":"Organisational matters - CHMP meeting 20-23 October 2014","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2014-10-29T12:20:00Z","last_updated_date":"2014-10-29T12:20:00Z","reference_number":"EMA/129702/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-20-23-october-2014_en.pdf"},
    {"id":"21517","name":"Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 3","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T17:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"EMA/926028/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-european-federation-pharmaceutical-industries-and-associations-modelling-and-simulation-workshop-break-out-session-3_en.pdf"},
    {"id":"21518","name":"Focus group meeting - Revision of bioequivalence guideline - Minutes of the meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2009-07-08T02:09:21Z","last_updated_date":"2009-07-08T02:09:21Z","reference_number":"EMEA/CVMP/EWP/290174/2009","document_url":"https://www.ema.europa.eu/en/documents/minutes/focus-group-meeting-revision-bioequivalence-guideline-minutes-meeting_en.pdf"},
    {"id":"21521","name":"Are We Doing Enough for Children's Pain? - Richard F Howard","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-10-28T02:09:21Z","last_updated_date":"2004-10-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/are-we-doing-enough-childrens-pain-richard-f-howard_en.pdf"},
    {"id":"21522","name":"PDCO monthly report of opinions on paediatric investigation plans: 7-9 December 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-12-16T15:00:00Z","last_updated_date":"2011-12-16T15:00:00Z","reference_number":"EMA/PDCO/925174/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-7-9-december-2011_en.pdf"},
    {"id":"21524","name":"Rubella vaccine (live, attenuated): List of nationally authorised medicinal products - PSUSA/00002670/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-15T12:00:00Z","last_updated_date":"2016-10-18T11:22:48Z","reference_number":"EMA/605631/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/rubella-vaccine-live-attenuated-list-nationally-authorised-medicinal-products-psusa00002670201501_en.pdf"},
    {"id":"21526","name":"Minutes of the Extraordinary Management Board meeting for the building approval process of EMA premises in Amsterdam: 28 February 2018","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2018-04-05T19:10:00Z","last_updated_date":"2018-04-05T19:10:00Z","reference_number":"EMA/MB/102052/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-extraordinary-management-board-meeting-building-approval-process-ema-premises-amsterdam-28-february-2018_en.pdf"},
    {"id":"21527","name":"Final list of references supporting the assessment of Ilex paraguariensis St. Hilaire, folium - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-02-14T01:00:00Z","last_updated_date":"2011-02-14T01:00:00Z","reference_number":"EMA/HMPC/580546/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-ilex-paraguariensis-st-hilaire-folium-first-version_en.pdf"},
    {"id":"21528","name":"Draft community herbal monograph on Ribes nigrum L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/142986/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-ribes-nigrum-l-folium_en.pdf"},
    {"id":"21530","name":"Final assessment report on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-10-06T02:00:00Z","last_updated_date":"2014-10-06T02:00:00Z","reference_number":"EMA/HMPC/680615/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
    {"id":"21531","name":"Diovan - EMEA/H/A/-29 PAD/1220 - Artical 29 Paediatrics referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diovan-emeaha-29-pad1220-artical-29-paediatrics-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"21532","name":"Substance, product, organisation, referentials (SPOR) - Application program interface (API) schema","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-15T19:00:00Z","last_updated_date":"2017-03-15T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/substance-product-organisation-referentials-spor-application-program-interface-api-schema_en.zip"},
    {"id":"21533","name":"Annex VI to procedure for conducting GCP inspections requested by the CHMP: Record keeping and archiving of documents","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2022-05-05T13:30:00Z","reference_number":"EMA/INS/GCP/183077/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-vi-procedure-conducting-gcp-inspections-requested-chmp-record-keeping-and-archiving-documents_en.pdf"},
    {"id":"21534","name":"Opinion following an Article 33 referral for Combimox Lactating Cow and associated names: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-12-08T01:00:00Z","last_updated_date":"2011-12-08T01:00:00Z","reference_number":"EMEA/V/A/61","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-33-referral-combimox-lactating-cow-and-associated-names-background-information_sv.pdf"}},
    {"id":"21535","name":"Iclusig Article-20 procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-11-10T01:00:00Z","last_updated_date":"2014-11-10T01:00:00Z","reference_number":"EMA/667786/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-prac-assessment-report_en.pdf"},
    {"id":"21538","name":"EU/3/16/1804: Public summary of opinion on orphan designation: Pegylated recombinant human interleukin-10 for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/758032/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161804-public-summary-opinion-orphan-designation-pegylated-recombinant-human-interleukin-10-treatment-pancreatic-cancer_en.pdf"},
    {"id":"21540","name":"European Medicines Agency welcomes publication of the Clinical Trials Regulation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-05-28T02:00:00Z","last_updated_date":"2014-05-28T02:00:00Z","reference_number":"EMA/324129/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-welcomes-publication-clinical-trials-regulation_en.pdf"},
    {"id":"21541","name":"CVMP summary of positive opinion for Zulvac 1+8 Bovis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-01-13T01:00:00Z","last_updated_date":"2011-01-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-zulvac-18-bovis_en.pdf"},
    {"id":"21544","name":"Presentation - CHMP feedback (H. Enzmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:50:00Z","last_updated_date":"2017-12-11T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmp-feedback-h-enzmann_en.pdf"},
    {"id":"21545","name":"Draft guideline on selection of test materials for genotoxicity testing for traditional herbal medicinal products/ herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-06-08T02:00:00Z","last_updated_date":"2009-06-08T02:00:00Z","reference_number":"EMEA/HMPC/67644/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-selection-test-materials-genotoxicity-testing-traditional-herbal-medicinal-products-herbal-medicinal-products_en.pdf"},
    {"id":"21546","name":"Attachment 2 for change of scientific opinion holder","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-08-05T17:20:00Z","last_updated_date":"2014-08-05T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/attachment-2-change-scientific-opinion-holder_en.doc"},
    {"id":"21547","name":"EU/3/12/988: Public summary of opinion on orphan designation: Halofuginone hydrobromide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2015-03-23T12:00:00Z","reference_number":"EMA/COMP/203967/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312988-public-summary-opinion-orphan-designation-halofuginone-hydrobromide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"21549","name":"Exemestane: List of nationally authorised medicinal products - PSUSA/00001345/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-09T02:00:00Z","last_updated_date":"2016-10-18T16:14:16Z","reference_number":"EMA/603169/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/exemestane-list-nationally-authorised-medicinal-products-psusa00001345201512_en.pdf"},
    {"id":"21551","name":"Note for guidance on specification limits for residues of metal catalysts","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2002-12-17T01:00:00Z","last_updated_date":"2002-12-17T01:00:00Z","reference_number":"CPMP/SWP/QWP/4446/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-specification-limits-residues-metal-catalysts_en.pdf"},
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    {"id":"21553","name":"CTAG1: Clinical Trial Advisory Group on protecting patient confidentiality - Membership overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag1-clinical-trial-advisory-group-protecting-patient-confidentiality-membership-overview_en.pdf"},
    {"id":"21556","name":"Presentation - Session 2: Applying the sentinel common data model to electronic medical records: PCORnet Experience (Lesley H Curtis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-applying-sentinel-common-data-model-electronic-medical-records-pcornet-experience-lesley-h-curtis_en.pdf"},
    {"id":"21557","name":"Carbetocin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-02-01T01:00:00Z","last_updated_date":"1996-02-01T01:00:00Z","reference_number":"EMEA/MRL/054/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/carbetocin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21559","name":"Presentation - Projects to deliver better IT systems and business change management (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-projects-deliver-better-it-systems-and-business-change-management-peter-arlett_en.pdf"},
    {"id":"21560","name":"Open invitation to tender, EMEA/2006/32/DIR, External members of EMEA's audit advisory committee","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-06-28T02:00:00Z","last_updated_date":"2006-06-28T02:00:00Z","reference_number":"EMEA/171075/2006","document_url":"https://www.ema.europa.eu/en/documents/other/open-invitation-tender-emea200632dir-external-members-emeas-audit-advisory-committee_en.pdf"},
    {"id":"21561","name":"Summary of the evaluation of the proposed paediatric investigation plan: Clonidine for treatment of painful diabetic neuropathy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-19T02:00:00Z","last_updated_date":"2015-10-19T02:00:00Z","reference_number":"EMA/629293/2015","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-clonidine-treatment-painful-diabetic-neuropathy_en.pdf"},
    {"id":"21562","name":"Cardioxane Article 13 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-26T11:42:00Z","last_updated_date":"2017-07-26T11:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cardioxane-article-13-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cardioxane-article-13-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cardioxane-article-13-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cardioxane-article-13-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cardioxane-article-13-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cardioxane-article-13-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cardioxane-article-13-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cardioxane-article-13-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cardioxane-article-13-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cardioxane-article-13-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cardioxane-article-13-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cardioxane-article-13-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cardioxane-article-13-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cardioxane-article-13-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cardioxane-article-13-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cardioxane-article-13-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cardioxane-article-13-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cardioxane-article-13-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cardioxane-article-13-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cardioxane-article-13-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cardioxane-article-13-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cardioxane-article-13-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cardioxane-article-13-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/cardioxane-article-13-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/cardioxane-article-13-referral-annex-i_no.pdf"}},
    {"id":"21564","name":"List of participants - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - Worksho...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"EMA/348114/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-worksho_en.pdf"},
    {"id":"21565","name":"Draft list of references supporting the assessment of Juniperus communis L., aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/HMPC/12399/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-juniperus-communis-l-aetheroleum_en.pdf"},
    {"id":"21566","name":"CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Krka d.d.","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-02-24T01:00:00Z","last_updated_date":"2017-02-24T01:00:00Z","reference_number":"EMA/CHMP/75449/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-emtricitabinetenofovir-disoproxil-krka-dd_en.pdf"},
    {"id":"21568","name":"European Medicines Agency concludes review of dose recommendations for anti-tuberculosis medicines used in children","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T12:00:00Z","last_updated_date":"2012-02-17T12:00:00Z","reference_number":"EMA/CHMP/123373/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-review-dose-recommendations-anti-tuberculosis-medicines-used-children_en.pdf"},
    {"id":"21569","name":"Public statement on Infanrix HepB: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-08-04T14:49:21Z","last_updated_date":"2005-08-04T14:49:21Z","reference_number":"EMEA/245029/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-infanrix-hepb-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"21570","name":"Summary of the evaluation of the proposed paediatric investigation plan: Trifarotene for the treatment of acne","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/384282/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-trifarotene-treatment-acne_en.pdf"},
    {"id":"21572","name":"EudraVigilance veterinary / Signal detection and on-going related veterinary-information technology (IT) projects","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2016-10-07T17:30:00Z","reference_number":"EMA/13787/2009","document_url":"https://www.ema.europa.eu/en/documents/report/eudravigilance-veterinary-signal-detection-and-going-related-veterinary-information-technology-it-projects_en.pdf"},
    {"id":"21574","name":"Wyeth Europa Ltd withdraws its marketing authorisation application for\n\nPristiqs (desvenlafaxine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-12T01:00:00Z","last_updated_date":"2008-03-12T01:00:00Z","reference_number":"EMEA/128068/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/wyeth-europa-ltd-withdraws-its-marketing-authorisation-application-pristiqs-desvenlafaxine_en.pdf"},
    {"id":"21576","name":"Workshop programme - Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal ...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-06-26T02:00:00Z","last_updated_date":"2014-06-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/workshop-programme-committee-advanced-therapies-cat-and-german-society-transfusion-medicine-and-immunohaematology-dgti-workshop-advanced-therapy-medicinal-products-how-bring-cell-based-medicinal_en.pdf"},
    {"id":"21578","name":"Presentation - PSUR repository (Ana Zanoletty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-psur-repository-ana-zanoletty_en.pdf"},
    {"id":"21579","name":"Summary of transfers of appropriations in budget 2017 - Management Board meeting: 5 October 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-06T17:00:00Z","last_updated_date":"2017-10-06T17:00:00Z","reference_number":"EMA/MB/573435/2017","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2017-management-board-meeting-5-october-2017_en.pdf"},
    {"id":"21580","name":"EU/3/04/226: Public summary of positive opinion for orphan designation: Recombinant human interleukin-21 for the treatment of renal-cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-10-01T02:00:00Z","last_updated_date":"2014-10-16T11:30:00Z","reference_number":"EMA/COMP/366/2004 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304226-public-summary-positive-opinion-orphan-designation-recombinant-human-interleukin-21-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"21582","name":"Opinion of the CVMP on the establishment of maximum residue limits: Rafoxanide","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-09-08T19:00:00Z","last_updated_date":"2014-09-08T19:00:00Z","reference_number":"EMA/CVMP/672931/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-rafoxanide_en.pdf"},
    {"id":"21584","name":"Potassium para aminobenzoate: List of nationally authorised medicinal products - PSUSA/00010130/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T11:00:00Z","last_updated_date":"2016-10-17T18:42:00Z","reference_number":"EMA/829642/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/potassium-para-aminobenzoate-list-nationally-authorised-medicinal-products-psusa00010130201502_en.pdf"},
    {"id":"21585","name":"Superseded final list of bibliographic references supporting the HMPC Assessment Report on Plantago afra L. Plantago indica L. semen (EMEA/HMPC/167338/2006)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:09:21Z","last_updated_date":"2013-07-29T14:00:00Z","reference_number":"EMEA/HMPC/167338/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-bibliographic-references-supporting-hmpc-assessment-report-plantago-afra-l-plantago-indica-l-semen-emeahmpc1673382006_en.pdf"},
    {"id":"21586","name":"ECDC/EFSA/EMA second joint report on the integrated\n\nanalysis of the consumption of antimicrobial agents and\n\noccurrence of antimicrobial resistance in bacteria from\n\nhumans and food-producing animals","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-07-27T12:00:00Z","last_updated_date":"2017-07-27T12:00:00Z","reference_number":"10.2903/j.efsa.2017.4872","document_url":"https://www.ema.europa.eu/en/documents/report/ecdcefsaema-second-joint-report-integrated-analysis-consumption-antimicrobial-agents-and-occurrence-antimicrobial-resistance-bacteria-humans-and-food-producing-animals_en.pdf"},
    {"id":"21587","name":"Medicines under additional monitoring","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-25T12:00:00Z","last_updated_date":"2013-10-24T11:30:00Z","reference_number":"EMA/244682/2013","document_url":"https://www.ema.europa.eu/en/documents/other/medicines-under-additional-monitoring_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/medicines-under-additional-monitoring_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/medicines-under-additional-monitoring_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/medicines-under-additional-monitoring_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/medicines-under-additional-monitoring_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/medicines-under-additional-monitoring_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/medicines-under-additional-monitoring_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/medicines-under-additional-monitoring_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/medicines-under-additional-monitoring_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/other/medicines-under-additional-monitoring_hr.pdf","it":"https://www.ema.europa.eu/it/documents/other/medicines-under-additional-monitoring_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/medicines-under-additional-monitoring_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/medicines-under-additional-monitoring_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/medicines-under-additional-monitoring_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/medicines-under-additional-monitoring_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/medicines-under-additional-monitoring_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/medicines-under-additional-monitoring_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/medicines-under-additional-monitoring_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/medicines-under-additional-monitoring_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/medicines-under-additional-monitoring_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/medicines-under-additional-monitoring_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/medicines-under-additional-monitoring_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/medicines-under-additional-monitoring_sv.pdf"}},
    {"id":"21588","name":"CHMP post-authorisation summary of positive opinion for Pegasys","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/CHMP/166776/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pegasys_en.pdf"},
    {"id":"21590","name":"Presentation - Challenges for the different stakeholders: regulatory perspective (Francesco Pignatti) - S1.4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-different-stakeholders-regulatory-perspective-francesco-pignatti-s14_en.pdf"},
    {"id":"21591","name":"Guideline on clinical investigation of steroid contraceptives in women","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"EMEA/CPMP/EWP/519/98 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-steroid-contraceptives-women_en.pdf"},
    {"id":"21592","name":"Fluralaner (poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2017-02-16T14:00:00Z","last_updated_date":"2017-02-16T14:00:00Z","reference_number":"EMA/CVMP/567262/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/fluralaner-poultry-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"21600","name":"Presentation - Superiority and organism-specific clinical trials of anitbacterial agents (Helen Boucher)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-superiority-and-organism-specific-clinical-trials-anitbacterial-agents-helen-boucher_en.pdf"},
    {"id":"21601","name":"Presentation - Maternal infant child and youth research network (MICYRN) (Anne Junker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-maternal-infant-child-and-youth-research-network-micyrn-anne-junker_en.pdf"},
    {"id":"21603","name":"Methylphenidate - Article 31 referral - Annex I, II, III, IV","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-07-14T02:08:21Z","last_updated_date":"2007-07-14T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methylphenidate-article-31-referral-annex-i-ii-iii-iv_sv.pdf"}},
    {"id":"21605","name":"Small and medium-sized enterprise (SME) Office annual report 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T17:00:00Z","last_updated_date":"2018-04-13T17:00:00Z","reference_number":"EMA/123438/2018","document_url":"https://www.ema.europa.eu/en/documents/report/small-and-medium-sized-enterprise-sme-office-annual-report-2017_en.pdf"},
    {"id":"21606","name":"Presentation - Key learnings from otamixaban development (Christophe Gaudin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-learnings-otamixaban-development-christophe-gaudin_en.pdf"},
    {"id":"21611","name":"CHMP post-authorisation summary of positive opinion for Xeljanz","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-04-27T13:24:00Z","last_updated_date":"2018-04-27T13:24:00Z","reference_number":"EMA/CHMP/244920/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xeljanz_en.pdf"},
    {"id":"21613","name":"Presentation - When do clinicians usually extrapolate in their practice? (Daniel Brasseur, Christoph Male)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-when-do-clinicians-usually-extrapolate-their-practice-daniel-brasseur-christoph-male_en.pdf"},
    {"id":"21614","name":"CHMP positive summary of opinion for Clopidogrel HCS","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2010-07-23T02:00:00Z","reference_number":"EMA/CHMP/442453/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-clopidogrel-hcs_en.pdf"},
    {"id":"21615","name":"Aspects of Pharmacovigilance in Neonates - Dirk Mentzer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-11T02:09:21Z","last_updated_date":"2006-10-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/aspects-pharmacovigilance-neonates-dirk-mentzer_en.pdf"},
    {"id":"21616","name":"Overview of comments received on 'guideline on pharmaceutical development of medicines for paediatric use' (EMA/CHMP/QWP/180157/2011)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-04T12:21:00Z","last_updated_date":"2013-01-04T12:21:00Z","reference_number":"EMA/805826/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-pharmaceutical-development-medicines-paediatric-use-emachmpqwp1801572011_en.pdf"},
    {"id":"21617","name":"Overview of comments on 'Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects'","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2018-05-02T16:00:00Z","last_updated_date":"2018-05-02T16:00:00Z","reference_number":"EMA/264099/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-draft-qualification-opinion-plasma-fibrinogen-prognostic-biomarker-drug-development-tool-all-cause-mortality-and-copd-exacerbations-copd-subjects_en.pdf"},
    {"id":"21618","name":"Overview of comments received on public statement on Viscum album L., herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2013-08-01T17:05:00Z","last_updated_date":"2013-08-01T17:05:00Z","reference_number":"EMA/HMPC/196894/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-public-statement-viscum-album-l-herba_en.pdf"},
    {"id":"21619","name":"Presentation - Working with young cancer patients: from experience to activity (R. Swierzewski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-10T18:30:00Z","last_updated_date":"2015-08-10T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-young-cancer-patients-experience-activity-r-swierzewski_en.pdf"},
    {"id":"21620","name":"Assessment Report for Diovan - EMEA/H/A/-29 PAD/1219","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-diovan-emeaha-29-pad1219_en.pdf"},
    {"id":"21621","name":"Extension of arrangement for shared non-public information regarding influenza A (H1N1) pandemic between the European Medicines Agency and the Swiss Agency for Therapeutic Products, Swissmedic","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-03T17:35:10Z","last_updated_date":"2012-02-03T17:35:10Z","reference_number":"EMA/66651/2012","document_url":"https://www.ema.europa.eu/en/documents/other/extension-arrangement-shared-non-public-information-regarding-influenza-h1n1-pandemic-between-european-medicines-agency-and-swiss-agency-therapeutic-products-swissmedic_en.pdf-0"},
    {"id":"21622","name":"Draft community herbal monograph on Thymus vulgaris L. and Thymus zygis L, herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-05-08T02:09:21Z","last_updated_date":"2007-05-08T02:09:21Z","reference_number":"EMEA/HMPC/234113/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba_en.pdf"},
    {"id":"21625","name":"Lactose of bovine origin Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-06T01:00:00Z","last_updated_date":"2017-09-04T02:00:00Z","reference_number":"EMA/818613/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lactose-bovine-origin-article-31-referral-annex-i_sv.pdf"}},
    {"id":"21628","name":"Hydrochlorothiazide / quinapril: List of nationally authorised medicinal products - PSUSA/00002592/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-22T01:00:00Z","last_updated_date":"2016-12-22T16:58:45Z","reference_number":"EMA/863940/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-quinapril-list-nationally-authorised-medicinal-products-psusa00002592201604_en.pdf"},
    {"id":"21630","name":"Overview of comments received on ' Guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease'\n\n(CHMP/EWP/1343/01 Rev.1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-30T02:00:00Z","last_updated_date":"2010-04-30T02:00:00Z","reference_number":"EMA/186797/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-evaluation-antifungal-agents-treatment-and-prophylaxis-invasive-fungal-disease-chmpewp134301-rev1_en.pdf"},
    {"id":"21631","name":"Prontax 5 mg/ml solution - Article 33 Referral - Annexes I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-07-05T02:00:00Z","last_updated_date":"2012-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/prontax-5-mgml-solution-article-33-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"21632","name":"EU/3/16/1737: Public summary of positive opinion for orphan designation of (E)-(6-((N-methyl-((3-methylbenzofuran-2-yl)methyl)amino)-3-oxoprop-1-en-1-yl)-2-oxo-3,4-dihydro-1,8-naphthyridin-1(2H)-yl)methyl phosphate, bis ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/623833/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161737-public-summary-positive-opinion-orphan-designation-e-6-n-methyl-3-methylbenzofuran-2-ylmethylamino-3-oxoprop-1-en-1-yl-2-oxo-34-dihydro-18-naphthyridin-12h-ylmethyl-phosphate-bis_en.pdf"},
    {"id":"21638","name":"Superseded assessment report on Primula veris L. and / or Primula elatior (L.) Hill, flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMA/HMPC/64683/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-primula-veris-l-and-or-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"21639","name":"Agenda - Focus Group Meeting of CVMP Experts and Interested Parties - Reflection paper on the use of fluoroquinolones in food producing animals","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"EMEA/228442/2006","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-focus-group-meeting-cvmp-experts-and-interested-parties-reflection-paper-use-fluoroquinolones-food-producing-animals_en.pdf"},
    {"id":"21643","name":"CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Final advice 4 April 2013 version 9.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-advice-european-medicines-agency-rules-engagement-accessing-clinical-trial-data-final-advice-4-april-2013-version-90_en.pdf"},
    {"id":"21644","name":"Presentation - Procedure for election of PCWP/HCPWP Co-Chairs 2016-2019 (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedure-election-pcwphcpwp-co-chairs-2016-2019-nathalie-bere_en.pdf"},
    {"id":"21645","name":"European Union influenza pandemic process map","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-08-21T02:09:21Z","last_updated_date":"2006-08-21T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-influenza-pandemic-process-map_en.pdf"},
    {"id":"21646","name":"Presentation - Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR) (Marco Cavaleri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-trans-atlantic-task-force-antimicrobial-resistance-tatfar-marco-cavaleri_en.pdf"},
    {"id":"21650","name":"Piceae turiones recentes extractum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2005-07-01T02:00:00Z","reference_number":"EMEA/CVMP/219201/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/piceae-turiones-recentes-extractum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"21653","name":"CHMP summary of opinion for Aerivio Spiromax","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2020-01-15T02:00:00Z","reference_number":"EMA/CHMP/431214/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-aerivio-spiromax_en.pdf"},
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    {"id":"21656","name":"EU/03/11/917: Public summary of opinion on orphan designation: Adeno-associated viral vector containing the human alpha-N-acetylglucosaminidase gene for the treatment of mucopolysaccharidosis type IIIB (Sanfilippo B synd...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2011-11-23T16:00:00Z","reference_number":"EMA/COMP/793344/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu0311917-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-alpha-n-acetylglucosaminidase-gene-treatment-mucopolysaccharidosis-type-iiib-sanfilippo-b-synd_en.pdf"},
    {"id":"21657","name":"European Medicines Agency Management Board adopt new policies on handling of conflicts of interests and on access to documents","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/618958/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-management-board-adopt-new-policies-handling-conflicts-interests-and-access-documents_en.pdf"},
    {"id":"21659","name":"Presentation - Invasive fungal infections (IFI) in neonates: the state of the art (Paolo Manzoni)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-invasive-fungal-infections-ifi-neonates-state-art-paolo-manzoni_en.pdf"},
    {"id":"21660","name":"Note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-04-26T02:00:00Z","last_updated_date":"2001-04-26T02:00:00Z","reference_number":"CPMP/EWP/567/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-and-prevention-bipolar-disorder_en.pdf"},
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    {"id":"21663","name":"Final assessment report on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-02-07T01:00:00Z","last_updated_date":"2012-02-07T01:00:00Z","reference_number":"EMA/HMPC/722365/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-cola-nitida-vent-schott-et-endl-and-its-varieties-and-cola-acuminata-p-beauv-schott-et-endl-semen_en.pdf"},
    {"id":"21664","name":"EU/3/14/1430: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human factor-VII gene for the treatment of congenital factor VII deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T12:00:00Z","last_updated_date":"2015-03-06T12:00:00Z","reference_number":"EMA/COMP/10146/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141430-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-factor-vii-gene-treatment-congenital-factor-vii-deficiency_en.pdf"},
    {"id":"21665","name":"Fourteenth pandemic pharmacovigilance update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-03-24T01:00:00Z","last_updated_date":"2010-03-24T01:00:00Z","reference_number":"EMA/190452/2010","document_url":"https://www.ema.europa.eu/en/documents/report/fourteenth-pandemic-pharmacovigilance-update_en.pdf"},
    {"id":"21668","name":"EU/3/17/1963: Public summary of opinion on orphan designation: Hydroxychloroquine sulphate for the treatment of LIPIN1 disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-13T01:00:00Z","last_updated_date":"2018-03-13T01:00:00Z","reference_number":"EMA/4249/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171963-public-summary-opinion-orphan-designation-hydroxychloroquine-sulphate-treatment-lipin1-disease_en.pdf"},
    {"id":"21669","name":"16th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1996-12-13T12:09:21Z","last_updated_date":"1996-12-13T12:09:21Z","reference_number":"EMEA/CVMP/264/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/16th-meeting-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"21673","name":"Draft guideline on adjuvants in vaccines","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-03-25T00:09:00Z","last_updated_date":"2004-03-25T00:09:00Z","reference_number":"EMEA/CPMP/VEG/17/03/2004v 5/Consultation","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-adjuvants-vaccines_en.pdf"},
    {"id":"21674","name":"Captopril: List of nationally authorised medicinal products - PSUSA/00000535/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2016-11-03T10:57:14Z","reference_number":"EMA/851887/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/captopril-list-nationally-authorised-medicinal-products-psusa00000535201504_en.pdf"},
    {"id":"21675","name":"Gadolinium Article-31 referral – Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T01:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-annex-iii_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gadolinium-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gadolinium-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gadolinium-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gadolinium-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gadolinium-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gadolinium-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gadolinium-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gadolinium-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gadolinium-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gadolinium-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gadolinium-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gadolinium-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gadolinium-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gadolinium-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gadolinium-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gadolinium-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gadolinium-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gadolinium-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gadolinium-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gadolinium-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gadolinium-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gadolinium-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/gadolinium-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/gadolinium-article-31-referral-annex-iii_no.pdf"}},
    {"id":"21676","name":"EU/3/14/1283: Public summary of opinion on orphan designation: Mixture of two adeno-associated viral vectors of serotye 8 containing the 5’-half sequence of human ABCA4 gene and the 3’-half sequence of human ABCA4 gene f...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-16T02:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMA/COMP/318161/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141283-public-summary-opinion-orphan-designation-mixture-two-adeno-associated-viral-vectors-serotye-8-containing-5-half-sequence-human-abca4-gene-and-3-half-sequence-human-abca4-gene-f_en.pdf"},
    {"id":"21678","name":"Joint audit programme for EEA GMP inspectorates JAP: Audit notification template","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-19T02:00:00Z","last_updated_date":"2022-12-09T15:00:00Z","reference_number":"EMA/INS/931781/2022 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-eea-gmp-inspectorates-jap-audit-notification-template_en.pdf"},
    {"id":"21679","name":"Semler Article-31 referral – Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T15:00:00Z","last_updated_date":"2016-11-17T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/semler-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/semler-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/semler-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/semler-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/semler-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/semler-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/semler-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/semler-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/semler-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/semler-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/semler-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/semler-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/semler-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/semler-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/semler-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/semler-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/semler-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/semler-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/semler-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/semler-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/semler-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/semler-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/semler-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"21681","name":"Report of the “Progress in the area of Antimicrobial Resistance – Veterinary Medicines” meeting, organised by the EMA and the HMA (veterinary)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-progress-area-antimicrobial-resistance-veterinary-medicines-meeting-organised-ema-and-hma-veterinary_en.pdf"},
    {"id":"21682","name":"Presentation - What do I expect from the European Medicines Agency in the next five years? (Mark Walport)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-20T01:00:00Z","last_updated_date":"2015-03-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-do-i-expect-european-medicines-agency-next-five-years-mark-walport_en.pdf"},
    {"id":"21688","name":"Presentation - What do manufacturers and importers have to do to prepare for European Union membership? (Vesna Koblar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-do-manufacturers-and-importers-have-do-prepare-european-union-membership-vesna-koblar_en.pdf"},
    {"id":"21689","name":"EFPIA position paper proposals - Geoff Barton","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/efpia-position-paper-proposals-geoff-barton_en.pdf"},
    {"id":"21691","name":"Eplerenone : List of nationally authorised medicinal products - PSUSA/00001236/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T10:43:00Z","last_updated_date":"2017-10-31T10:47:00Z","reference_number":"EMA/663798/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/eplerenone-list-nationally-authorised-medicinal-products-psusa00001236201703_en.pdf"},
    {"id":"21693","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Autologous collagen derived from human adipose tissue","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-10-22T14:15:00Z","last_updated_date":"2012-10-22T14:15:00Z","reference_number":"EMA/500730/2012","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-collagen-derived-human-adipose-tissue_en.pdf"},
    {"id":"21694","name":"Final European Union herbal monograph on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/HMPC/573241/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"21699","name":"Letter of invitation to tender - Procurement procedure EMA-2012-09-IF","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-04-04T14:30:00Z","reference_number":"EMA/954451/2011","document_url":"https://www.ema.europa.eu/en/documents/other/letter-invitation-tender-procurement-procedure-ema-2012-09-if_en.pdf"},
    {"id":"21701","name":"Overview of comments received on draft revision 2 of the SmPC guideline - Proposal for a revision of the European Commission guideline on summary of product characteristics","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-10-22T02:09:21Z","last_updated_date":"2009-10-22T02:09:21Z","reference_number":"EMEA/CHMP/663087/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-revision-2-smpc-guideline-proposal-revision-european-commission-guideline-summary-product-characteristics_en.pdf"},
    {"id":"21702","name":"Presentation - Why biomarkers in clinical drug development and use (Marisa Papaluca, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-why-biomarkers-clinical-drug-development-and-use-marisa-papaluca-ema_en.pdf"},
    {"id":"21703","name":"Presentation -  Multiplicity corrections in bioequivalence trials (Jiri Hofmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multiplicity-corrections-bioequivalence-trials-jiri-hofmann_en.pdf"},
    {"id":"21704","name":"EU/03/14/1275: Public summary of opinion on orphan designation of aganirsen for the treatment of central retinal vein occlusion","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/256922/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu03141275-public-summary-opinion-orphan-designation-aganirsen-treatment-central-retinal-vein-occlusion_en.pdf"},
    {"id":"21705","name":"Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species: Background 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    {"id":"21706","name":"Questions and answers on the referral for Betavert N tablets containing betahistine dihydrochloride (8 or 16 mg)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-04T02:08:21Z","last_updated_date":"2009-06-04T02:08:21Z","reference_number":"EMEA/403687/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-betavert-n-tablets-containing-betahistine-dihydrochloride-8-or-16-mg_sv.pdf"}},
    {"id":"21708","name":"Overview of comments received on European Union herbal monograph on Eschscholzia californica Cham., herba","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/HMPC/726116/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-eschscholzia-californica-cham-herba_en.pdf"},
    {"id":"21709","name":"Public statement on Photobarr: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-05-07T02:00:00Z","last_updated_date":"2012-05-07T02:00:00Z","reference_number":"EMA/284281/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-photobarr-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"21710","name":"Opinion following an Article-13 referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-18T13:00:00Z","last_updated_date":"2013-10-18T13:00:00Z","reference_number":"EMA/549503/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-13-referral-cydectin-triclamox-5-mgml-and-200-mgml-pour-solution-cattle_sv.pdf"}},
    {"id":"21718","name":"Summary information on a referral opinion following an arbitration pursuant to Article 29 of Directive 2001/83/EC, for Actilyse International Non-Proprietary Name (INN): Alteplase: Background information and Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-11-22T00:08:21Z","last_updated_date":"2002-11-22T00:08:21Z","reference_number":"CPMP/3346/02-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-29-directive-200183ec-actilyse-international-non-proprietary-name-inn-alteplase-background-information-and-annex-i_en.pdf"},
    {"id":"21719","name":"Cefotaxime: List of nationally authorised medicinal products - PSUSA/00000599/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-10-18T15:41:06Z","reference_number":"EMA/600481/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefotaxime-list-nationally-authorised-medicinal-products-psusa00000599201512_en.pdf"},
    {"id":"21722","name":"Questions and answers on the review of Avastin (bevacizumab) in the treatment of metastatic breast cancer","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-12-16T01:00:00Z","last_updated_date":"2010-12-16T01:00:00Z","reference_number":"EMA/CHMP/804031/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-avastin-bevacizumab-treatment-metastatic-breast-cancer_en.pdf"},
    {"id":"21723","name":"Superseded opinion of the committee on herbal medicinal products on a community herbal monograph on Echinacea purpurea (L.) Moench., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-03-06T00:09:21Z","last_updated_date":"2015-04-14T01:09:21Z","reference_number":"EMEA/HMPC/453709/2007EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-echinacea-purpurea-l-moench-herba_en.pdf"},
    {"id":"21725","name":"Defining the strategic vision for the EMA ‘Article 58’ process - Final read-out","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-04-26T17:30:00Z","last_updated_date":"2016-04-26T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/defining-strategic-vision-ema-article-58-process-final-read-out_en.pdf"},
    {"id":"21727","name":"Presentation - Reporting medication errors at national level: what should be reported and to whom (Mick Foy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reporting-medication-errors-national-level-what-should-be-reported-and-whom-mick-foy_en.pdf"},
    {"id":"21728","name":"Reflection on evolution and value of GCG - Mike Ward","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/reflection-evolution-and-value-gcg-mike-ward_en.pdf"},
    {"id":"21730","name":"Opinion of the HMPC on a European Union herbal monograph on Glycine max (L.) Merr., lecithinum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-11-20T01:00:00Z","last_updated_date":"2017-11-20T01:00:00Z","reference_number":"EMA/HMPC/66450/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-glycine-max-l-merr-lecithinum_en.pdf"},
    {"id":"21731","name":"Presentation - Roadmap to periodic safety update reports (PSUR) (Irene Rager, Menno van der Elst, Kora Doorduyn van der Stoep)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-roadmap-periodic-safety-update-reports-psur-irene-rager-menno-van-der-elst-kora-doorduyn-van-der-stoep_en.pdf"},
    {"id":"21734","name":"The treatment of pain in children: What can the EMEA do? - Agnà¨s Saint Raymond and Nathalie Seigneuret","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-10-28T02:09:21Z","last_updated_date":"2004-10-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/treatment-pain-children-what-can-emea-do-agnas-saint-raymond-and-nathalie-seigneuret_en.pdf"},
    {"id":"21735","name":"CHMP post-authorisation summary of positive opinion for Pritor on 22 October 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/CHMP/681834/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pritor-22-october-2009_en.pdf"},
    {"id":"21736","name":"EU/3/17/1831: Public summary of opinion on orphan designation: 505 amino acid protein, corresponding to amino acids 2-506 of the wild-type human histidyl-tRNA synthetase for the treatment of limb-girdle muscular dystroph...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/85417/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171831-public-summary-opinion-orphan-designation-505-amino-acid-protein-corresponding-amino-acids-2-506-wild-type-human-histidyl-trna-synthetase-treatment-limb-girdle-muscular-dystroph_en.pdf"},
    {"id":"21737","name":"Presentation - Declarations of interests: a practical guide","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-31T19:00:00Z","last_updated_date":"2016-08-31T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-declarations-interests-practical-guide_en.pdf"},
    {"id":"21738","name":"Questions and answers on the review of Vimpat (lacosamide) 15-mg/ml syrup","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-09-22T02:00:00Z","last_updated_date":"2011-09-22T02:00:00Z","reference_number":"EMA/CHMP/762478/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-vimpat-lacosamide-15-mgml-syrup_en.pdf"},
    {"id":"21739","name":"Presentation - What are safety communications and how to review them (Federica Castellani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-are-safety-communications-and-how-review-them-federica-castellani_en.pdf"},
    {"id":"21740","name":"EU/3/07/512: Public summary of positive opinion for orphan designation\n\nof 17-(allylamino)-17-demethoxygeldanamycin hydroquinone hydrochloride\n\nfor the treatment of malignant gastrointestinal stromal tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-03-25T01:00:00Z","reference_number":"EMEA/COMP/473573/2007 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307512-public-summary-positive-opinion-orphan-designation-17-allylamino-17-demethoxygeldanamycin-hydroquinone-hydrochloride-treatment-malignant-gastrointestinal-stromal-tumours_en.pdf"},
    {"id":"21742","name":"Diacerein: List of nationally authorised medicinal products - PSUSA/00001026/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-17T12:15:00Z","last_updated_date":"2018-07-17T12:15:00Z","reference_number":"EMA/483125/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/diacerein-list-nationally-authorised-medicinal-products-psusa00001026201712_en.pdf"},
    {"id":"21744","name":"CHMP post-authorisation summary of positive opinion for TachoSil (II-0041)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"EMA/CHMP/724928/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tachosil-ii-0041_en.pdf"},
    {"id":"21745","name":"Agenda - European network of paediatric research at the European Medicines Agency coordinating group meeting by teleconference - 24 October 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-02-02T15:00:00Z","last_updated_date":"2015-02-02T15:00:00Z","reference_number":"EMA/511563/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-network-paediatric-research-european-medicines-agency-coordinating-group-meeting-teleconference-24-october-2014_en.pdf"},
    {"id":"21746","name":"Summary information on a referral opinion following an arbitration pursuant to Article 11 of Council Directive 75/319/EEC as amended for Engerix B - common Name: recombinant hepatitis B vaccine: Background information an...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2000-08-28T02:08:21Z","last_updated_date":"2000-08-28T02:08:21Z","reference_number":"CPMP/1493/01","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-11-council-directive-75319eec-amended-engerix-b-common-name-recombinant-hepatitis-b-vaccine-background-information_en.pdf"},
    {"id":"21748","name":"Agenda - Thirteenth industry stakeholder platform - operation of EU pharmacovigilance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-03-14T14:06:00Z","last_updated_date":"2018-03-14T14:06:00Z","reference_number":"EMA/117206/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-thirteenth-industry-stakeholder-platform-operation-eu-pharmacovigilance_en.pdf"},
    {"id":"21752","name":"The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future: Part I: The European Medicines Agency Strategy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-03-07T01:00:00Z","last_updated_date":"2005-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-road-map-2010-preparing-ground-future-part-i-european-medicines-agency-strategy_en.pdf"},
    {"id":"21753","name":"Agenda - CAT agenda of the 30-31 October 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-10-31T17:25:00Z","last_updated_date":"2017-10-31T17:25:00Z","reference_number":"EMA/CAT/726328/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-30-31-october-2017-meeting_en.pdf"},
    {"id":"21761","name":"EU/3/06/362: Public summary of positive opinion for orphan designation of\n\nhuman heterologous liver cells (for infusion) for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/96573/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306362-public-summary-positive-opinion-orphan-designation-human-heterologous-liver-cells-infusion-treatment-acute-liver-failure_en.pdf"},
    {"id":"21763","name":"Presentation - EMA/HMA action plan on availability for veterinary vaccines (Faye Ioannou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T02:00:00Z","last_updated_date":"2017-03-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emahma-action-plan-availability-veterinary-vaccines-faye-ioannou_en.pdf"},
    {"id":"21765","name":"Final community herbal monograph on Syzygium aromaticum (L.) Merill et L. M. Perry, floris aetheroleum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T01:00:00Z","last_updated_date":"2011-12-21T01:00:00Z","reference_number":"EMA/HMPC/534924/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-syzygium-aromaticum-l-merill-et-l-m-perry-floris-aetheroleum_en.pdf"},
    {"id":"21767","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Valeriana officinalis L., radix (Valerianae aetheroleum)","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-06-20T02:00:00Z","last_updated_date":"2016-06-20T02:00:00Z","reference_number":"EMEA/HMPC/313368/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-valeriana-officinalis-l-radix-valerianae-aetheroleum_en.pdf"},
    {"id":"21768","name":"Diacerein Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-19T02:00:00Z","last_updated_date":"2014-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diacerein-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diacerein-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diacerein-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diacerein-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diacerein-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diacerein-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diacerein-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diacerein-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/diacerein-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diacerein-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diacerein-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diacerein-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diacerein-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diacerein-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diacerein-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diacerein-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diacerein-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diacerein-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diacerein-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diacerein-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diacerein-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diacerein-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"21769","name":"Presentation - Post licensing evidence generation (PLEG) (Jane Moseley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:31:00Z","last_updated_date":"2018-06-06T17:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-post-licensing-evidence-generation-pleg-jane-moseley_en.pdf"},
    {"id":"21771","name":"CHMP post-authorisation summary of positive opinion for Ozurdex","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-07-20T02:00:00Z","last_updated_date":"2012-07-20T02:00:00Z","reference_number":"EMA/CHMP/271228/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ozurdex_en.pdf-0"},
    {"id":"21772","name":"PDCO meeting highlights 1-3 April 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/PDCO/201824/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-1-3-april-2009_en.pdf"},
    {"id":"21773","name":"Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-05-11T12:30:00Z","last_updated_date":"2016-05-11T12:30:00Z","reference_number":"EMA/242286/2016","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-sme-office-survey-implementation-sme-regulation-commission-regulation-ec-no-20492005_en.pdf"},
    {"id":"21777","name":"Overview of comments received on 'qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for positron-emission-tomography amyloid imaging (positive / negative) as a biomarker for enrichment, for us...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-04-04T19:00:00Z","last_updated_date":"2012-04-04T19:00:00Z","reference_number":"EMA/991202/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-qualification-opinion-alzheimers-disease-novel-methodologies-biomarkers-positron-emission-tomography-amyloid-imaging-positive-negative-biomarker-enrichment-us_en.pdf"},
    {"id":"21779","name":"Draft guideline on clinical investigation of immunosuppressants for solid organ transplantation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"CHMP/EWP/263148/06","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-immunosuppressants-solid-organ-transplantation_en.pdf"},
    {"id":"21780","name":"Start of community reviews - CHMP meeting of 20-23 July 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T14:00:00Z","last_updated_date":"2015-07-24T14:00:00Z","reference_number":"EMA/495872/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-20-23-july-2015_en.pdf"},
    {"id":"21781","name":"CHMP summary of positive opinion for Menveo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/796967/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-menveo_en.pdf"},
    {"id":"21782","name":"PRIME - The first 12 months","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T19:30:00Z","last_updated_date":"2017-05-18T19:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prime-first-12-months_en.pdf"},
    {"id":"21783","name":"Request for CHMP qualification opinion on efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-15T19:00:00Z","last_updated_date":"2013-10-15T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/request-chmp-qualification-opinion-efficient-statistical-methodology-model-based-design-and-analysis-phase-ii-dose-finding-studies-under-model-uncertainty_en.pdf"},
    {"id":"21784","name":"Call for submission of scientific data relating to the assessment of Colae semen Cola nitida (Vent.) Schott et Endl. (c. Vera K. Schum.) and Cola acuminata (P. Beauv.) Schott et Endl. (Sterculia acuminata P. Beauv.), sem...","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-10-15T02:09:21Z","last_updated_date":"2009-10-15T02:09:21Z","reference_number":"EMEA/HMPC/604684/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-colae-semen-cola-nitida-vent-schott-et-endl-c-vera-k-schum-and-cola-acuminata-p-beauv-schott-et-endl-sterculia-acuminata-p-beauv-sem_en.pdf"},
    {"id":"21787","name":"The European innovation offices network - innovators meet regulators","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T12:00:00Z","last_updated_date":"2018-04-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/european-innovation-offices-network-innovators-meet-regulators_en.pdf"},
    {"id":"21789","name":"CVMP summary of positive opinion for Procox","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-02-11T01:00:00Z","last_updated_date":"2011-02-11T01:00:00Z","reference_number":"EMA/CVMP/533373/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-procox_en.pdf"},
    {"id":"21790","name":"Presentation - Introduction on the background, rationale and expected outputs (Jean-Pierre Orand)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-background-rationale-and-expected-outputs-jean-pierre-orand_en.pdf"},
    {"id":"21792","name":"European and US regulators agree on mutual recognition of inspections of medicines manufacturers","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T14:00:00Z","last_updated_date":"2017-03-02T14:00:00Z","reference_number":"EMA/34520/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-and-us-regulators-agree-mutual-recognition-inspections-medicines-manufacturers_en.pdf"},
    {"id":"21795","name":"EU/3/11/855: Public summary of positive opinion for orphan designation: Recombinant fusion protein linking human coagulation factor VIIa with human albumin for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2011-04-26T02:00:00Z","reference_number":"EMA/COMP/76909/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311855-public-summary-positive-opinion-orphan-designation-recombinant-fusion-protein-linking-human-coagulation-factor-viia-human-albumin-treatment-haemophilia_en.pdf"},
    {"id":"21796","name":"Beractant: List of nationally authorised medicinal products - PSUSA/00000384/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-18T14:01:14Z","reference_number":"EMA/345845/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/beractant-list-nationally-authorised-medicinal-products-psusa00000384201510_en.pdf"},
    {"id":"21797","name":"Guideline on influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"EMEA/CHMP/VWP/263499/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-influenza-vaccines-prepared-viruses-potential-cause-pandemic-and-intended-use-outside-core-dossier-context_en.pdf"},
    {"id":"21798","name":"CVMP post-authorisation summary of positive opinion for Nobivac LeuFel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T02:00:00Z","last_updated_date":"2018-06-22T02:00:00Z","reference_number":"EMA/CVMP/113131/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-nobivac-leufel_en.pdf"},
    {"id":"21800","name":"Recommendation to marketing authorisation holders, highlighting the need to ensure compliance with 3Rs methods described in the European Pharmacopoeia","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-07-25T12:40:00Z","last_updated_date":"2012-07-25T12:40:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/252137/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-marketing-authorisation-holders-highlighting-need-ensure-compliance-3rs-methods-described-european-pharmacopoeia_en.pdf"},
    {"id":"21801","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 21-24 July 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-29T18:15:00Z","last_updated_date":"2014-08-01T18:30:00Z","reference_number":"EMA/125405/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-21-24-july-2014_en.pdf"},
    {"id":"21802","name":"Draft list of references supporting the assessment of Salvia officinalis L., folium and Salvia officinalis L., aetheroleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-02-15T12:00:00Z","last_updated_date":"2016-02-15T12:00:00Z","reference_number":"EMA/HMPC/277151/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-salvia-officinalis-l-folium-and-salvia-officinalis-l-aetheroleum_en.pdf"},
    {"id":"21804","name":"Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T13:10:00Z","last_updated_date":"2018-01-18T13:10:00Z","reference_number":"EMA/36828/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-topical-use-list-nationally-authorised-medicinal-products-psusa00010376201704_en.pdf"},
    {"id":"21805","name":"Questions and answers on the withdrawal of the marketing authorisation application for Zactima (vandetanib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/726915/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-zactima-vandetanib_en.pdf"},
    {"id":"21806","name":"EU/3/12/1074 : Public summary of opinion on orphan designation: Alisertib for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic / disseminated)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-24T13:15:00Z","last_updated_date":"2017-02-07T17:44:00Z","reference_number":"EMA/COMP/743664/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121074-public-summary-opinion-orphan-designation-alisertib-treatment-peripheral-t-cell-lymphoma-nodal-other-extranodal-and-leukaemic-disseminated_en.pdf"},
    {"id":"21808","name":"Presentation - International Neonatal Consortium: Welcome","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-neonatal-consortium-welcome_en.pdf"},
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    {"id":"21813","name":"Final assessment report on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-06-09T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"EMA/HMPC/85124/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"21814","name":"EU/3/03/133: Public summary of positive opinion for orphan designation of icatibant acetate for treatment of angioedema","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-04-09T02:00:00Z","last_updated_date":"2013-09-24T01:00:00Z","reference_number":"EMEA/COMP/86/03 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303133-public-summary-positive-opinion-orphan-designation-icatibant-acetate-treatment-angioedema_en.pdf"},
    {"id":"21815","name":"Report - Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma kinase aberrations)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-06-01T17:50:00Z","last_updated_date":"2017-06-01T17:50:00Z","reference_number":"EMA/210027/2017","document_url":"https://www.ema.europa.eu/en/documents/report/report-multi-stakeholder-paediatric-oncology-strategy-workshop-cancers-anaplastic-lymphoma-kinase-aberrations_en.pdf"},
    {"id":"21818","name":"Presentation - Experience in benefit risk referral procedure – Combined hormonal contraceptives (Hildrun Sundseth)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-benefit-risk-referral-procedure-combined-hormonal-contraceptives-hildrun-sundseth_en.pdf"},
    {"id":"21819","name":"EU/3/16/1613: Public summary of opinion on orphan designation: Tolfenamic acid for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/75475/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161613-public-summary-opinion-orphan-designation-tolfenamic-acid-treatment-progressive-supranuclear-palsy_en.pdf"},
    {"id":"21820","name":"Committee for medicinal products for veterinary use: Meeting of 6 to 8 December 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-12-09T12:09:21Z","last_updated_date":"2006-12-09T12:09:21Z","reference_number":"EMEA/CVMP/401112/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-6-8-december-2005_en.pdf"},
    {"id":"21822","name":"EU/3/16/1799: Public summary of opinion on orphan designation: Cabiralizumab for the treatment of tenosynovial giant cell tumour, localised and diffuse type","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2020-08-12T01:00:00Z","reference_number":"EMA/753362/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161799-public-summary-opinion-orphan-designation-cabiralizumab-treatment-tenosynovial-giant-cell-tumour-localised-and-diffuse-type_en.pdf"},
    {"id":"21823","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Taraxacum officinale Weber ex Wigg., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMEA/HMPC/583004/2009EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-folium_en.pdf"},
    {"id":"21825","name":"European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/602582/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-authorisation-two-vaccines-influenza-pandemic-h1n1-2009_en.pdf"},
    {"id":"21826","name":"EU/3/16/1759: Public summary of positive opinion for orphan designation of recombinant adeno-associated viral vector encoding a human micro-dystrophin gene under the control of a muscle specific promoter for the treatmen...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/614751/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161759-public-summary-positive-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-encoding-human-micro-dystrophin-gene-under-control-muscle-specific-promoter-treatmen_en.pdf"},
    {"id":"21828","name":"Prulifloxacin: List of nationally authorised medicinal products   - PSUSA/00002569/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-09T14:20:00Z","last_updated_date":"2018-08-09T14:27:16Z","reference_number":"EMA/542253/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/prulifloxacin-list-nationally-authorised-medicinal-products-psusa00002569201710_en.pdf"},
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    {"id":"21831","name":"EU/3/06/394: Public summary of positive opinion for orphan designation of autologous tumor-derived immunoglobulin idiotype coupled to keyhole limpet haemocyanin for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2012-06-14T02:00:00Z","reference_number":"EMEA/COMP/280125/2006 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306394-public-summary-positive-opinion-orphan-designation-autologous-tumor-derived-immunoglobulin-idiotype-coupled-keyhole-limpet-haemocyanin-treatment-follicular-lymphoma_en.pdf"},
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    {"id":"21837","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-06-10T15:00:00Z","last_updated_date":"2013-06-13T02:00:00Z","reference_number":"EMA/339116/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-prac-assessment-report_en.pdf"},
    {"id":"21838","name":"Agenda - Joint BWP/QWP/GMDP IWG – Industry European workshop on lifecycle management","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-10-12T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/468878/2015 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-bwpqwpgmdp-iwg-industry-european-workshop-lifecycle-management_en.pdf"},
    {"id":"21840","name":"Diclofenac / misoprostol: List of national authorised medicinal products - PSUSA/00001040/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T12:40:00Z","last_updated_date":"2018-04-27T12:59:00Z","reference_number":"EMA/265069/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/diclofenac-misoprostol-list-national-authorised-medicinal-products-psusa00001040201707_en.pdf"},
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    {"id":"21843","name":"Presentation - Development of drugs for paediatric neuromyelitis optica (Cheryl Hemingway)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-paediatric-neuromyelitis-optica-cheryl-hemingway_en.pdf"},
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    {"id":"21861","name":"Scientific recommendation on classification of advanced therapy medicinal products: mesenchymal stem cells isolated from umbilical cord seeded onto acellular dermal matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T17:00:00Z","last_updated_date":"2016-04-12T17:00:00Z","reference_number":"EMA/240994/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-mesenchymal-stem-cells-isolated-umbilical-cord-seeded-acellular-dermal-matrix_en.pdf"},
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    {"id":"21879","name":"EU/3/10/763: Public summary of opinion on orphan designation of Dexamethasone (intravitreal implant) for the treatment of non-infectious uveitis affecting the posterior segment of the eye","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-11T01:31:00Z","last_updated_date":"2010-11-19T00:31:00Z","reference_number":"EMA/COMP/319872/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310763-public-summary-opinion-orphan-designation-dexamethasone-intravitreal-implant-treatment-non-infectious-uveitis-affecting-posterior-segment-eye_en.pdf"},
    {"id":"21881","name":"Presentation - Potency and stability testing for ATMP (Marcel Hoefnagel, Charlotte De Wolf)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-27T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-potency-and-stability-testing-atmp-marcel-hoefnagel-charlotte-de-wolf_en.pdf"},
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    {"id":"21884","name":"Draft entry to list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products: Valerian root (valeriana, radix)","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-10-24T02:09:21Z","last_updated_date":"2005-10-24T02:09:21Z","reference_number":"EMEA/HMPC/340779/2005","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-entry-list-herbal-substances-preparations-and-combinations-thereof-use-traditional-herbal-medicinal-products-valerian-root-valeriana-radix_en.pdf"},
    {"id":"21888","name":"Standard operating procedure for procedures in accordance with Article 78 of Directive 2001/82/EC, related to pharmacovigilance measures for veterinary medicinal products authorised in the European Union","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-04-19T17:07:00Z","last_updated_date":"2016-02-11T15:45:00Z","reference_number":"SOP/V/4025","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-procedures-accordance-article-78-directive-200182ec-related-pharmacovigilance-measures-veterinary-medicinal-products-authorised-european-union_en.pdf"},
    {"id":"21890","name":"Meeting highlights from the Paediatric Committee: 6 - 8 May 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-05-15T02:00:00Z","last_updated_date":"2008-05-15T02:00:00Z","reference_number":"EMEA/PDCO/246860/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-6-8-may-2008_en.pdf"},
    {"id":"21892","name":"Emergency contraceptives Article-31 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/464144/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/emergency-contraceptives-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"21893","name":"Presentation - Implementation of the ICH Q3D guideline in the Ph. Eur. (Bruno Spieldenner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-ich-q3d-guideline-ph-eur-bruno-spieldenner_en.pdf"},
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    {"id":"21897","name":"Involvement of SAGAM in the evaluation of applications for centralised\n\nmarketing authorisations containing antimicrobial substances","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-02-01T01:00:00Z","last_updated_date":"2005-02-01T01:00:00Z","reference_number":"EMEA/CVMP/1136/04","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/involvement-sagam-evaluation-applications-centralised-marketing-authorisations-containing-antimicrobial-substances_en.pdf"},
    {"id":"21898","name":"CHMP summary of positive opinion for Simbrinza","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/CHMP/276487/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-simbrinza_en.pdf"},
    {"id":"21899","name":"Guidelines and concept papers adopted during the CHMP meeting 12-15 September 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-09-23T18:35:00Z","last_updated_date":"2016-09-23T18:35:00Z","reference_number":"EMA/76622/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-12-15-september-2016_en.pdf"},
    {"id":"21900","name":"Guideline on immunogenicity assessment of monoclonal antibodies intended for in-vivo clinical use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-15T17:10:50Z","last_updated_date":"2012-06-15T17:10:50Z","reference_number":"EMA/CHMP/BMWP/86289/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use_en.pdf"},
    {"id":"21901","name":"EU/3/17/1885: Public summary of opinion on orphan designation: Sildenafil for the treatment of congenital diaphragmatic hernia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/336708/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171885-public-summary-opinion-orphan-designation-sildenafil-treatment-congenital-diaphragmatic-hernia_en.pdf"},
    {"id":"21902","name":"Final community herbal monograph on Hamamelis virginiana L., folium cortex aut ramunculus destillatum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"EMA/HMPC/114584/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-hamamelis-virginiana-l-folium-cortex-aut-ramunculus-destillatum_en.pdf"},
    {"id":"21903","name":"VICH GL32: Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-16T02:00:00Z","last_updated_date":"2004-06-16T02:00:00Z","reference_number":"CVMP/VICH/485/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl32-studies-evaluate-safety-residues-veterinary-drugs-human-food-developmental-toxicity-testing-step-7_en.pdf"},
    {"id":"21904","name":"Presentation - Performance and context based established conditions for analytical procedures","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-17T01:00:00Z","last_updated_date":"2015-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-performance-and-context-based-established-conditions-analytical-procedures_en.pdf"},
    {"id":"21909","name":"Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Lumiracoxib, Parecoxib, and Valdecoxib International Non-Proprietary Name (INN): etoricoxib: Background 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    {"id":"21910","name":"Superseded list of references supporting the assessment of Plantago ovate Forssk., seminis tegumentum","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMEA/HMPC/165838/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-plantago-ovate-forssk-seminis-tegumentum_en.pdf"},
    {"id":"21912","name":"EU/3/12/1034: Public summary of opinion on orphan designation: Humanised monoclonal antibody against P-selectin for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-26T16:30:00Z","last_updated_date":"2012-09-26T16:30:00Z","reference_number":"EMA/COMP/516702/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121034-public-summary-opinion-orphan-designation-humanised-monoclonal-antibody-against-p-selectin-treatment-sickle-cell-disease_en.pdf"},
    {"id":"21914","name":"Committee for Medicinal Products for Human Use (CHMP) - March 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-03-28T01:00:00Z","last_updated_date":"2003-03-28T01:00:00Z","reference_number":"EMEA/CPMP/13508/03","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-march-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"21915","name":"Zinbryta Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T01:00:00Z","last_updated_date":"2018-03-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-timetable-procedure_en.pdf"},
    {"id":"21916","name":"CVMP summary of positive opinion for Eryseng Parvo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/CVMP/158893/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-eryseng-parvo_en.pdf"},
    {"id":"21919","name":"European Commision - Canada mutual recognition agreement: Sectoral annex on good manufacturing practices - Ninth joint sectoral group meeting update on the operation of the sectoral annex","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-10T02:00:00Z","last_updated_date":"2007-10-10T02:00:00Z","reference_number":"EMEA/INS/MRA/470284/2007","document_url":"https://www.ema.europa.eu/en/documents/other/european-commision-canada-mutual-recognition-agreement-sectoral-annex-good-manufacturing-practices-ninth-joint-sectoral-group-meeting-update-operation-sectoral-annex_en.pdf"},
    {"id":"21925","name":"Report from the first European Medicines Agency workshop with healthcare professional organisations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2006-04-20T02:00:00Z","last_updated_date":"2006-04-20T02:00:00Z","reference_number":"EMEA/124808/2006 corr.","document_url":"https://www.ema.europa.eu/en/documents/report/report-first-european-medicines-agency-workshop-healthcare-professional-organisations_en.pdf"},
    {"id":"21927","name":"Presentation - Utility of preclinical pharmacokinetic-pharmacodynamic modelling in QT safety testing - Break-out session 1 theme 1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:45:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-utility-preclinical-pharmacokinetic-pharmacodynamic-modelling-qt-safety-testing-break-out-session-1-theme-1_en.pdf"},
    {"id":"21931","name":"PDCO meeting highlights 12-14 March 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-04-25T02:00:00Z","last_updated_date":"2008-04-25T02:00:00Z","reference_number":"EMEA/PDCO/133735/2008-corr","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-12-14-march-2008_en.pdf"},
    {"id":"21933","name":"Overview of comments received on 'Draft guideline on the clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency’ (EMA/CHMP/355988/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T13:46:00Z","last_updated_date":"2016-10-20T13:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-prevent-developmentslow-progression-chronic-renal-insufficiency-emachmp3559882014_en.pdf"},
    {"id":"21935","name":"CHMP summary of positive opinion for Neuraceq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/CHMP/772521/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-neuraceq_en.pdf"},
    {"id":"21936","name":"PDCO meeting highlights 19-21 May 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/PDCO/323686/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-19-21-may-2010_en.pdf"},
    {"id":"21937","name":"European Medicines Agency recommends no changes\n\nfor Tamiflu safety information","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-12-15T00:09:21Z","last_updated_date":"2005-12-15T00:09:21Z","reference_number":"EMEA/420087/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-no-changes-tamiflu-safety-information_en.pdf"},
    {"id":"21938","name":"EU/3/17/1890: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-14T16:54:00Z","last_updated_date":"2022-02-21T16:54:00Z","reference_number":"EMA/407154/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171890-public-summary-opinion-orphan-designation-autologous-cd4-and-cd8-t-cells-expressing-cd19-specific-chimeric-antigen-receptor-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"21939","name":"Agenda - CAT agenda of the 10-11 December 2015 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T17:20:00Z","last_updated_date":"2015-12-14T17:20:00Z","reference_number":"EMA/CAT/841770/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-10-11-december-2015-meeting_en.pdf"},
    {"id":"21940","name":"Assessment report for bisphosphonates containing medicinal products","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"EMA/725125/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-bisphosphonates-containing-medicinal-products_en.pdf"},
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    {"id":"21945","name":"Agenda and registration form - EMA Information Day: 2nd Information Day on the New Individual Case Safety Report (ICSR) International Standard and ICH E2B/M2","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-03-24T01:00:00Z","last_updated_date":"2011-03-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-ema-information-day-2nd-information-day-new-individual-case-safety-report-icsr-international-standard-and-ich-e2bm2_en.pdf"},
    {"id":"21946","name":"Dienogest / Ethinylestradiol Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T12:00:00Z","last_updated_date":"2017-03-24T12:00:00Z","reference_number":"EMEA/H/A-31/1435","document_url":"https://www.ema.europa.eu/en/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/dienogest-ethinylestradiol-article-31-referral-annex-i_no.pdf"}},
    {"id":"21949","name":"EMEA Workshop on the feasibility of Biosimilar monoclonal Antibodies - Welcome - Xavier Luria","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-workshop-feasibility-biosimilar-monoclonal-antibodies-welcome-xavier-luria_en.pdf"},
    {"id":"21952","name":"Updated recommendations to minimise the risk of the rare brain infection PML with Tecfidera","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T14:00:02Z","last_updated_date":"2015-10-23T14:00:02Z","reference_number":"EMA/627077/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/updated-recommendations-minimise-risk-rare-brain-infection-pml-tecfidera_en.pdf"},
    {"id":"21953","name":"CAT meeting dates 2015, 2016, 2017 and 2018","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-06T13:00:00Z","last_updated_date":"2015-01-06T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cat-meeting-dates-2015-2016-2017-and-2018_en.pdf"},
    {"id":"21956","name":"Presentation - Experience and opportunities for the co-development (process) of companion diagnostics and medicinal products (in the EU) (Falk Ehmann, Efthymios Manolis and Armin Ritzhaupt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T18:21:00Z","last_updated_date":"2017-05-12T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-and-opportunities-co-development-process-companion-diagnostics-and-medicinal-products-eu-falk-ehmann-efthymios-manolis-and-armin-ritzhaupt_en.pdf"},
    {"id":"21957","name":"Withdrawal assessment report for Exelon and Prometax","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-05-21T02:00:00Z","last_updated_date":"2012-05-21T02:00:00Z","reference_number":"EMA/270221/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-exelon-and-prometax_en.pdf"},
    {"id":"21958","name":"The beekeeper’s perspective on medicines for bees, Walter Haefeker, European Professional Beekeepers Association","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/beekeepers-perspective-medicines-bees-walter-haefeker-european-professional-beekeepers-association_en.pdf"},
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    {"id":"22031","name":"Doxastad 4mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-10-11T02:08:21Z","last_updated_date":"2006-10-11T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/doxastad-4mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"22034","name":"EU/3/12/1085 : Public summary of opinion on orphan designation: Voclosporin for the treatment of non-infectious uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2013-01-25T12:00:00Z","reference_number":"EMA/COMP/728485/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121085-public-summary-opinion-orphan-designation-voclosporin-treatment-non-infectious-uveitis_en.pdf"},
    {"id":"22035","name":"Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2014","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2015-03-03T11:00:00Z","last_updated_date":"2015-03-03T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-dialogue-meeting-december-2014_en.pdf"},
    {"id":"22037","name":"EU/3/02/096: Public summary of positive opinion for orphan designation of nitisinone for the treatment of alkaptonuria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-06T00:00:00Z","last_updated_date":"2014-07-11T19:00:00Z","reference_number":"EMEA/COMP/140/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302096-public-summary-positive-opinion-orphan-designation-nitisinone-treatment-alkaptonuria_en.pdf"},
    {"id":"22038","name":"Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T17:20:00Z","last_updated_date":"2016-11-04T17:27:00Z","reference_number":"EMA/728880/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/latanoprost-products-paediatric-indication-list-nationally-authorised-medicinal-products-psusa00001834201604_en.pdf"},
    {"id":"22040","name":"EU/3/11/865: Public summary of opinion on orphan designation: 9-cis-Retinyl acetate for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2012-01-04T01:00:00Z","reference_number":"EMA/COMP/167703/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311865-public-summary-opinion-orphan-designation-9-cis-retinyl-acetate-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"22041","name":"ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals - questions and answers - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-05-16T13:39:00Z","last_updated_date":"2018-05-16T13:39:00Z","reference_number":"EMA/CHMP/ICH/453684/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s9-guideline-nonclinical-evaluation-anticancer-pharmaceuticals-questions-and-answers-step-5_en.pdf"},
    {"id":"22043","name":"'First-in-man' clinical trials guideline released for public consultation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-03-26T02:00:00Z","last_updated_date":"2007-03-26T02:00:00Z","reference_number":"EMEA/122833/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-man-clinical-trials-guideline-released-public-consultation_en.pdf"},
    {"id":"22045","name":"CHMP post-authorisation summary of positive opinion for INOmax","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/CHMP/733047/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-inomax_en.pdf"},
    {"id":"22046","name":"European Medicines Agency recommends suspension of oral buflomedil-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/394156/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-oral-buflomedil-containing-medicines_en.pdf"},
    {"id":"22047","name":"Public statement on Rivastigmine 3M Health Care Ltd: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-09-18T02:00:00Z","last_updated_date":"2014-09-18T02:00:00Z","reference_number":"EMEA/H/C/003824","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-rivastigmine-3m-health-care-ltd-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"22048","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Lutathera (lutetium (177Lu) oxodotreotide) for the treatment of gastro-entero-pancreatic neuroendocrine tumours","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2018-01-17T12:33:00Z","last_updated_date":"2018-01-17T12:33:00Z","reference_number":"EMA/552373/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-lutathera-lutetium-177lu-oxodotreotide-treatment-gastro-entero-pancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"22050","name":"Presentation - Publication of Risk Management Plan (RMP) summaries: Analysis of the experience of the 1-year pilot phase (Juan Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-publication-risk-management-plan-rmp-summaries-analysis-experience-1-year-pilot-phase-juan-garcia_en.pdf"},
    {"id":"22051","name":"EU/3/09/716: Public summary of opinion on orphan designation of benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl] for the treatment of chronic ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/COMP/804530/2009 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309716-public-summary-opinion-orphan-designation-benzamide-3-2-imidazo12-bpyridazin-3-ylethynyl-4-methyl-n-4-4-methyl-1-piperazinylmethyl-3-trifluoromethylphenyl-treatment-chronic_en.pdf"},
    {"id":"22052","name":"EU/3/12/962: Public summary of opinion on orphan designation: Chimeric monoclonal antibody against kappa myeloma antigen for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T18:00:00Z","last_updated_date":"2015-06-08T18:00:00Z","reference_number":"EMA/COMP/67144/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312962-public-summary-opinion-orphan-designation-chimeric-monoclonal-antibody-against-kappa-myeloma-antigen-treatment-multiple-myeloma_en.pdf"},
    {"id":"22053","name":"Summary on compassionate use for Sofosbuvir Gilead","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-03T17:45:00Z","last_updated_date":"2020-10-26T11:22:00Z","reference_number":"EMA/697409/2013","document_url":"https://www.ema.europa.eu/en/documents/other/summary-compassionate-use-sofosbuvir-gilead_en.pdf"},
    {"id":"22055","name":"Gene therapy product quality aspects In the production of vectors and genetically modified somatic cells","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1994-12-31T01:00:00Z","last_updated_date":"1994-12-31T01:00:00Z","reference_number":"3ab6a","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/gene-therapy-product-quality-aspects-production-vectors-and-genetically-modified-somatic-cells_en.pdf"},
    {"id":"22056","name":"Decision on amending budget No 1-2015","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/MB/50215/2015","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-1-2015_en.pdf"},
    {"id":"22057","name":"Schering-Plough Europe withdraws its marketing authorisation application for Zenhale (mometasone furoate/formoterol fumarate)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-11-09T01:00:00Z","last_updated_date":"2010-11-09T01:00:00Z","reference_number":"EMA/700091/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/schering-plough-europe-withdraws-its-marketing-authorisation-application-zenhale-mometasone-furoateformoterol-fumarate_en.pdf"},
    {"id":"22058","name":"Presentation - The risk in transplanted patients, Marco Tuccori","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-transplanted-patients-marco-tuccori_en.pdf"},
    {"id":"22060","name":"33rd meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-06-11T02:09:21Z","last_updated_date":"1998-06-11T02:09:21Z","reference_number":"EMEA/CVMP/257/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/33rd-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"22064","name":"EU/3/14/1242: Public summary of opinion on orphan designation: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone for the treatment of Rett syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-02T14:00:00Z","last_updated_date":"2014-04-02T14:00:00Z","reference_number":"EMA/COMP/29766/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141242-public-summary-opinion-orphan-designation-3-chloro-4-fluorophenyl-4-fluoro-4-5-methylpyrimidin-2-ylmethyl-aminomethylpiperidin-1-ylmethanone-treatment-rett-syndrome_en.pdf"},
    {"id":"22066","name":"Structure of the list of herbal substances, preparations and combinations thereof","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-07-13T02:00:00Z","last_updated_date":"2006-07-13T02:00:00Z","reference_number":"EMEA/HMPC/100824/2005 Revision 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/structure-list-herbal-substances-preparations-and-combinations-thereof_en.pdf"},
    {"id":"22067","name":"Presentation - Introduction and regulatory update (Paula Salmikangas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-and-regulatory-update-paula-salmikangas_en.pdf"},
    {"id":"22068","name":"CHMP post-authorisation summary of positive opinion for Silgard","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2019-04-02T02:00:00Z","reference_number":"EMEA/CHMP/280938/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-silgard_en.pdf-0"},
    {"id":"22069","name":"Overview of designated orphan medicines that have been the subject of a centralised application for marketing authorisation, CHMP meeting 18-22 September 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/770530/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-designated-orphan-medicines-have-been-subject-centralised-application-marketing-authorisation-chmp-meeting-18-22-september-2011_en.pdf"},
    {"id":"22071","name":"Opinion following an Article 30 referral for Risperdal Consta and associated names International Non-Proprietary Name (INN): risperidone: Background 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    {"id":"22120","name":"HMPWG in the view of the NCA Objectives, Achievements, Roles and Responsibilities - Werner Knà¶ss","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/hmpwg-view-nca-objectives-achievements-roles-and-responsibilities-werner-knapss_en.pdf"},
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    {"id":"22277","name":"Resource requirements of the CVMP","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-06-11T02:09:21Z","last_updated_date":"2009-06-11T02:09:21Z","reference_number":"EMEA/MB/301036/2009","document_url":"https://www.ema.europa.eu/en/documents/other/resource-requirements-cvmp_en.pdf"},
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    {"id":"22281","name":"EU/3/13/1186: Public summary of opinion on orphan designation: Idelalisib for the treatment of extranodal marginal-zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-16T02:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/COMP/434309/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131186-public-summary-opinion-orphan-designation-idelalisib-treatment-extranodal-marginal-zone-lymphoma-mucosa-associated-lymphoid-tissue-malt-lymphoma_en.pdf"},
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    {"id":"22288","name":"Workshop on the guideline for First-in-Man Clinical trials for potential high-risk\n\nmedicinal products - Overview of comments - Highlights - J-M Vidal","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/workshop-guideline-first-man-clinical-trials-potential-high-risk-medicinal-products-overview-comments-highlights-j-m-vidal_en.pdf"},
    {"id":"22291","name":"Zydelig Article-20 procedure - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-annex-i-ii-iii_en.pdf"},
    {"id":"22292","name":"Opinion of the HMPC on a European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-09-01T02:00:00Z","last_updated_date":"2017-09-01T02:00:00Z","reference_number":"EMA/HMPC/481429/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-prunus-africana-hook-f-kalkm-cortex_en.pdf"},
    {"id":"22295","name":"Template for sections A to E for the scientific part of the application for orphan designation","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2011-10-14T12:25:00Z","last_updated_date":"2023-04-20T09:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-sections-e-scientific-part-application-orphan-designation_en.docx"},
    {"id":"22297","name":"Avastin - PI","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-16T01:00:00Z","last_updated_date":"2010-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/avastin-pi_en.pdf"},
    {"id":"22299","name":"Codeine Article-31 referral - PRAC recommends restricting the use of codeine when used for pain relief in children","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"EMA/350259/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-prac-recommends-restricting-use-codeine-when-used-pain-relief-children_en.pdf"},
    {"id":"22304","name":"Committee for Medicinal Products for Human Use (CHMP) - May 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-06-05T02:00:00Z","last_updated_date":"2007-06-05T02:00:00Z","reference_number":"EMEA/222371/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-may-2007-plenary-meeting-monthly-report_en.pdf"},
    {"id":"22309","name":"Acarbose: List of nationally authorised medicinal products - PSUSA/00000017/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-09T01:00:00Z","last_updated_date":"2016-10-17T16:41:47Z","reference_number":"EMA/98477/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/acarbose-list-nationally-authorised-medicinal-products-psusa00000017201503_en.pdf"},
    {"id":"22311","name":"EU/3/03/172: Public summary of positive opinion for orphan designation of trientine dihydrochloride for the treatment of Wilson's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-04-26T02:00:00Z","last_updated_date":"2014-10-08T01:00:00Z","reference_number":"EMEA/COMP/1469/03 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303172-public-summary-positive-opinion-orphan-designation-trientine-dihydrochloride-treatment-wilsons-disease_en.pdf"},
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    {"id":"22317","name":"Methylprednisolone: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00002026/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T01:00:00Z","last_updated_date":"2016-10-18T11:46:15Z","reference_number":"EMA/733977/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylprednisolone-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002026201411_en.pdf"},
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    {"id":"22333","name":"Data submission of authorised medicines in the European Union: Outlines on Article 57(2) of Regulation (EC) No 726/2004","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T12:00:00Z","last_updated_date":"2015-02-23T13:15:00Z","reference_number":"EMA/471367/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/data-submission-authorised-medicines-european-union-outlines-article-572-regulation-ec-no-7262004_en.pdf"},
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    {"id":"22341","name":"Gaxilose: List of nationally authorised medicinal products - PSUSA/00010283/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-10-18T16:56:40Z","reference_number":"EMA/599321/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gaxilose-list-nationally-authorised-medicinal-products-psusa00010283201601_en.pdf"},
    {"id":"22342","name":"Overview of comments on 'Draft qualification opinion on molecular neuroimaging of the dopamine transporter as biomarker to identify patients with early manifest Parkinsonism in Parkinson’s disease'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T17:00:00Z","last_updated_date":"2018-07-19T17:00:00Z","reference_number":"EMA/9764/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-draft-qualification-opinion-molecular-neuroimaging-dopamine-transporter-biomarker-identify-patients-early-manifest-parkinsonism-parkinsons-disease_en.pdf"},
    {"id":"22343","name":"EU/3/09/648: Public summary of positive opinion for orphan designation of\n\nafamelanotide for the treatment of solar urticaria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-11T02:00:00Z","last_updated_date":"2013-07-08T02:00:00Z","reference_number":"EMEA/COMP/386616/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309648-public-summary-positive-opinion-orphan-designation-afamelanotide-treatment-solar-urticaria_en.pdf"},
    {"id":"22346","name":"European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/84749/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-protelososseor-remain-available-further-restrictions_en.pdf"},
    {"id":"22348","name":"Guideline on core summary for product characteristics  for human albumin solution - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-08-13T16:30:00Z","last_updated_date":"2018-08-13T16:30:00Z","reference_number":"EMA/CHMP/BPWP/494462/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-human-albumin-solution-revision-3_en.pdf"},
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    {"id":"22353","name":"EU/3/15/1535: Public summary of opinion on orphan designation: Fibrinogen-coated albumin spheres for the treatment of acute radiation syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/508238/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151535-public-summary-opinion-orphan-designation-fibrinogen-coated-albumin-spheres-treatment-acute-radiation-syndrome_en.pdf"},
    {"id":"22354","name":"List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T17:00:00Z","last_updated_date":"2021-09-16T09:50:00Z","reference_number":"EMA/701527/2017 Corr. 7","document_url":"https://www.ema.europa.eu/en/documents/other/list-active-substances-involved-pilot-signal-detection-eudravigilance-marketing-authorisation-holders_en.xls"},
    {"id":"22356","name":"EU/3/08/531: Public summary of positive opinion for orphan designation of ascorbic acid for the treatment of Charcot-Marie-Tooth disease type 1A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2014-04-01T18:00:00Z","reference_number":"EMEA/COMP/265714/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308531-public-summary-positive-opinion-orphan-designation-ascorbic-acid-treatment-charcot-marie-tooth-disease-type-1a_en.pdf"},
    {"id":"22358","name":"Hydroxyzine Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T17:00:00Z","last_updated_date":"2014-05-08T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-notification_en.pdf"},
    {"id":"22359","name":"Launch of PRIME – Paving the way for promising medicines for patients","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2016-03-07T12:00:00Z","reference_number":"EMA/89921/2016 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/launch-prime-paving-way-promising-medicines-patients_en.pdf"},
    {"id":"22360","name":"One database – two answers, Ten databases – million answers - Tjeerd-Pieter van Staa","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/one-database-two-answers-ten-databases-million-answers-tjeerd-pieter-van-staa_en.pdf"},
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    {"id":"22362","name":"Florfenicol (Extension to fish): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-07-01T02:00:00Z","last_updated_date":"1997-07-01T02:00:00Z","reference_number":"EMEA/MRL/251/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/florfenicol-extension-fish-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"22369","name":"Presentation - European Group for Generic Veterinary Products considerations (Elsa Vecino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T13:00:00Z","last_updated_date":"2013-04-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-group-generic-veterinary-products-considerations-elsa-vecino_en.pdf"},
    {"id":"22370","name":"PRAC confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T14:00:00Z","last_updated_date":"2013-10-11T14:00:00Z","reference_number":"EMA/607314/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-confirms-benefits-all-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_en.pdf"},
    {"id":"22371","name":"EU/3/15/1450: Public summary of positive opinion for orphan designation of gallium (68Ga)-edotreotide for the diagnosis of gastro-entero-pancreatic neuroendocrine tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/125762/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151450-public-summary-positive-opinion-orphan-designation-gallium-68ga-edotreotide-diagnosis-gastro-entero-pancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"22374","name":"Flugestone acetate: Summary report  (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-12-01T01:00:00Z","last_updated_date":"2002-12-01T01:00:00Z","reference_number":"EMEA/MRL/859/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flugestone-acetate-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"22380","name":"Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (revision) - Superseded","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CPMP/VEG/4717/2003- Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-dossier-structure-and-content-pandemic-influenza-vaccine-marketing-authorisation-application-revision-superseded_en.pdf"},
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    {"id":"22382","name":"EU/3/14/1328: Public summary of opinion on orphan designation: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/457064/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141328-public-summary-opinion-orphan-designation-4-2r3s4r5s-4-4-chloro-2-fluoro-phenyl-3-3-chloro-2-fluoro-phenyl-4-cyano-5-22-dimethyl-propyl-pyrrolidine-2-carbonyl-amino-3-methoxy-benzoic_en.pdf"},
    {"id":"22383","name":"CHMP summary of opinion for Wakix","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T13:00:00Z","last_updated_date":"2015-11-20T13:00:00Z","reference_number":"EMA/CHMP/759419/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-wakix_en.pdf"},
    {"id":"22384","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Autologous stromal vascular fraction","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:59:00Z","last_updated_date":"2018-01-03T14:59:00Z","reference_number":"EMA/699234/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-stromal-vascular-fraction_en.pdf"},
    {"id":"22386","name":"Spectinomycin (sheep and chicken eggs): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/623/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spectinomycin-sheep-and-chicken-eggs-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"22390","name":"ICH guideline Q4B annex 11 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on capillary electrophoresis - general chapter - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T12:00:00Z","reference_number":"EMA/CHMP/ICH/730028/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-11-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-capillary-electrophoresis-general-chapter-step-5_en.pdf"},
    {"id":"22391","name":"Call for submission of scientific data relating to the assessment of Fraxini folium Fraxinus excelsior L. or Fraxinus oxyphylla M. Bieb., folium (ash leaf)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/HMPC/604802/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-fraxini-folium-fraxinus-excelsior-l-or-fraxinus-oxyphylla-m-bieb-folium-ash-leaf_en.pdf"},
    {"id":"22394","name":"Presentation - Value of fundamental scientific approaches to understanding stability in lifecycle change management (Ron Ogilvie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-17T01:00:00Z","last_updated_date":"2015-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-value-fundamental-scientific-approaches-understanding-stability-lifecycle-change-management-ron-ogilvie_en.pdf"},
    {"id":"22396","name":"Invirase amended PI for publication","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-21T02:00:00Z","last_updated_date":"2010-10-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/invirase-amended-pi-publication_en.pdf"},
    {"id":"22397","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Macugen (pegaptanib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/CHMP/563649/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-macugen-pegaptanib_en.pdf"},
    {"id":"22399","name":"Public summary of the evaluation of the proposed product-specific waiver: Pacritinib for treatment of post-polycythaemia vera myelofibrosis and treatment of post-essential thrombocythaemia myelofibrosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T13:00:00Z","last_updated_date":"2014-10-21T13:00:00Z","reference_number":"EMA/515156/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-pacritinib-treatment-post-polycythaemia-vera-myelofibrosis-and-treatment-post-essential-thrombocythaemia-myelofibrosis_en.pdf"},
    {"id":"22401","name":"Brief summary of the existing systems on collecting data: France","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-france_en.pdf"},
    {"id":"22402","name":"Presentation - 3.4 Discussion on extrapolation (Heinz Schmidli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-34-discussion-extrapolation-heinz-schmidli_en.pdf"},
    {"id":"22403","name":"EMEA/CHMP working group with Healthcare Professionals' Organisations (HCP WG) - Draft recommendations and proposals for action","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2008-06-26T02:09:21Z","reference_number":"EMEA/185036/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/emeachmp-working-group-healthcare-professionals-organisations-hcp-wg-draft-recommendations-and-proposals-action_en.pdf"},
    {"id":"22406","name":"CVMP post-authorisation summary of positive opinion for Advocate","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-19T18:00:00Z","last_updated_date":"2013-07-19T18:00:00Z","reference_number":"EMA/CVMP/428221/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-advocate_en.pdf"},
    {"id":"22407","name":"Minutes of the ninth meeting of the EMA Human Scientific Committees’ Working Party with Patients' and Consumers' Organisations (PCWP), 30 September 2009","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"EMA/625710/2009","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ninth-meeting-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-30-september-2009_en.pdf"},
    {"id":"22408","name":"CHMP post-authorisation summary of positive opinion for Briviact","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T15:33:00Z","last_updated_date":"2018-06-01T15:33:00Z","reference_number":"EMA/CHMP/327758/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-briviact_en.pdf"},
    {"id":"22409","name":"Letter of invitation to tender - EMA/2012/03/HR","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-24T09:50:00Z","last_updated_date":"2012-01-24T09:50:00Z","reference_number":"EMA/925173/2011","document_url":"https://www.ema.europa.eu/en/documents/other/letter-invitation-tender-ema201203hr_en.pdf"},
    {"id":"22410","name":"Public summary of negative opinion for orphan designation of tramadol hydrochloride for the treatment of painful HIV-associated neuropathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/COMP/223605/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-tramadol-hydrochloride-treatment-painful-hiv-associated-neuropathy_en.pdf"},
    {"id":"22412","name":"EU/3/14/1250: Public summary of opinion on orphan designation: Phosphorothioate oligonucleotide targeted to transthyretin for the treatment of ATTR amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-06T02:00:00Z","last_updated_date":"2014-05-06T02:00:00Z","reference_number":"EMA/COMP/95948/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141250-public-summary-opinion-orphan-designation-phosphorothioate-oligonucleotide-targeted-transthyretin-treatment-attr-amyloidosis_en.pdf"},
    {"id":"22414","name":"Presentation - The Paediatric Regulation as an instrument for\n\nEuropean paediatric research","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T15:25:52Z","last_updated_date":"2011-05-27T15:25:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-regulation-instrument-european-paediatric-research_en.pdf"},
    {"id":"22415","name":"New treatment option for rare inflammatory disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-02-23T01:00:00Z","reference_number":"EMA/CHMP/111554/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-treatment-option-rare-inflammatory-disease_en.pdf"},
    {"id":"22416","name":"Guidance on the description of composition of pegylated (conjugated) proteins in the SPC","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-05-14T02:00:00Z","last_updated_date":"2003-05-14T02:00:00Z","reference_number":"EMEA/CPMP/BWP/3068/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidance-description-composition-pegylated-conjugated-proteins-spc_en.pdf"},
    {"id":"22421","name":"Diclofenac Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-31T18:00:00Z","last_updated_date":"2012-10-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-notification_en.pdf"},
    {"id":"22422","name":"10th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1996-03-22T12:49:21Z","last_updated_date":"1996-03-22T12:49:21Z","reference_number":"EMEA/CVMP/053/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/10th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"22424","name":"Valproate and related substances Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/valproate-and-related-substances-article-31-referral-annex-i_no.pdf"}},
    {"id":"22426","name":"Presentation - Summary of interim results from analysis of field efficacy data for centrally authorised products (M.  Ilott)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:30:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summary-interim-results-analysis-field-efficacy-data-centrally-authorised-products-m-ilott_en.pdf"},
    {"id":"22430","name":"Presentation - Nanoparticles, Rogà©rio Gaspar, University of Lisbon","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nanoparticles-rogacrio-gaspar-university-lisbon_en.pdf"},
    {"id":"22431","name":"Paediatric addendum to the Committee for Medicinal Products for Human Use guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-02-07T17:36:00Z","last_updated_date":"2012-02-07T17:36:00Z","reference_number":"EMA/CHMP/213972/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paediatric-addendum-committee-medicinal-products-human-use-guideline-clinical-investigations-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"22433","name":"EU/3/18/2007: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene for the treatment of glycogen storage disease type II (Pompe's dise...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T13:00:00Z","last_updated_date":"2018-05-17T13:00:00Z","reference_number":"EMA/184668/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182007-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-acid-alpha-glucosidase-gene-treatment-glycogen-storage-disease-type-ii-pompes-dise_en.pdf"},
    {"id":"22434","name":"Phenol: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/040/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phenol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"22435","name":"European Medicines Agency recommends restricting the use of modafinil","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/459173/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-modafinil_en.pdf"},
    {"id":"22437","name":"Iclusig Article-20 procedure - Product information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/641476/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-product-information_en.pdf-0"},
    {"id":"22438","name":"Hydroxyethyl starch Article-107i referral - PRAC List of questions to be addressed by the stakeholders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T14:00:00Z","last_updated_date":"2017-10-27T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-prac-list-questions-be-addressed-stakeholders_en.pdf"},
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    {"id":"22446","name":"Alcon Laboratories (UK) Ltd withdraws its application to extend the marketing authorisation for Opatanol","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-02-23T01:00:00Z","last_updated_date":"2006-02-23T01:00:00Z","reference_number":"EMEA/57801/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/alcon-laboratories-uk-ltd-withdraws-its-application-extend-marketing-authorisation-opatanol_en.pdf"},
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    {"id":"22475","name":"Overview of Review Process Interactions - Anthony Humphreys","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-review-process-interactions-anthony-humphreys_en.pdf"},
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    {"id":"22544","name":"Bacterial lysate medicines Article 31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"EMA/CHMP/346196/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/bacterial-lysate-medicines-article-31-referral-notification_en.pdf"},
    {"id":"22545","name":"Substances related to nicotinic acid Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-03-13T18:00:00Z","last_updated_date":"2014-03-13T18:00:00Z","reference_number":"EMA/PRAC/18751/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-assessment-report_en.pdf"},
    {"id":"22547","name":"CHMP summary of positive opinion for Topotecan Hospira","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"EMA/CHMP/43325/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-topotecan-hospira_en.pdf"},
    {"id":"22548","name":"European Medicines Agency budget for 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T13:05:00Z","last_updated_date":"2012-03-12T11:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-budget-2012_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/european-medicines-agency-budget-2012_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/european-medicines-agency-budget-2012_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/european-medicines-agency-budget-2012_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/european-medicines-agency-budget-2012_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/european-medicines-agency-budget-2012_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/european-medicines-agency-budget-2012_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/european-medicines-agency-budget-2012_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/european-medicines-agency-budget-2012_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/european-medicines-agency-budget-2012_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/european-medicines-agency-budget-2012_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/european-medicines-agency-budget-2012_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/european-medicines-agency-budget-2012_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/european-medicines-agency-budget-2012_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/european-medicines-agency-budget-2012_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/european-medicines-agency-budget-2012_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/european-medicines-agency-budget-2012_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/european-medicines-agency-budget-2012_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/european-medicines-agency-budget-2012_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/european-medicines-agency-budget-2012_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/european-medicines-agency-budget-2012_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/european-medicines-agency-budget-2012_sv.pdf"}},
    {"id":"22549","name":"Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-tobramycin-vvb-and-associated-names-tobramycin-300-mg5-ml-nebuliser-solution_sv.pdf"}},
    {"id":"22551","name":"Presentation - Incentives and regulatory considerations: Situation in Europe (Segundo Mariz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-incentives-and-regulatory-considerations-situation-europe-segundo-mariz_en.pdf"},
    {"id":"22553","name":"Presentation - Session 4.3: Immunogenicity of monoclonal antibodies: Risk-based approach – What are the risk factors?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:58Z","last_updated_date":"2012-06-15T17:10:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-43-immunogenicity-monoclonal-antibodies-risk-based-approach-what-are-risk-factors_en.pdf"},
    {"id":"22555","name":"CHMP summary of opinion for Palonosetron Hospira","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2022-04-08T01:00:00Z","reference_number":"EMA/CHMP/131135/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-palonosetron-hospira_en.pdf"},
    {"id":"22556","name":"EU/3/16/1795: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human CNGA3 gene under the control of a cone arrestin promoter for the treatment of achromatopsia cau...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/746037/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161795-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-cnga3-gene-under-control-cone-arrestin-promoter-treatment-achromatopsia-cau_en.pdf"},
    {"id":"22560","name":"Independence & Transparency - Minutes of working group 2","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2008-04-28T02:00:00Z","last_updated_date":"2008-04-28T02:00:00Z","reference_number":"EMEA/230056/2008","document_url":"https://www.ema.europa.eu/en/documents/minutes/independence-transparency-minutes-working-group-2_en.pdf"},
    {"id":"22573","name":"Overview of comments received on draft public statement on Piper methysticum G. Forst., rhizoma","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2018-04-13T02:00:00Z","reference_number":"EMA/HMPC/326583/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-draft-public-statement-piper-methysticum-g-forst-rhizoma_en.pdf"},
    {"id":"22576","name":"Good manufacturing practice: An analysis of regulatory inspection findings in the centralised procedure in 2006 and plasma-master-file procedure during 2004-2006 period","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-04-08T02:00:00Z","last_updated_date":"2008-04-08T02:00:00Z","reference_number":"EMEA/INS/GMP/594072/2007","document_url":"https://www.ema.europa.eu/en/documents/other/good-manufacturing-practice-analysis-regulatory-inspection-findings-centralised-procedure-2006-and-plasma-master-file-procedure-during-2004-2006-period_en.pdf"},
    {"id":"22577","name":"CPMP List of herbal drugs with serious risks","type":"other","status":"unknown","consultation_date":"","first_published_date":"1992-10-26T01:00:00Z","last_updated_date":"1992-10-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cpmp-list-herbal-drugs-serious-risks_en.pdf"},
    {"id":"22581","name":"Annual accounts: Financial year 2013","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-07-01T12:15:00Z","last_updated_date":"2014-07-01T12:15:00Z","reference_number":"EMA/277014/2014","document_url":"https://www.ema.europa.eu/en/documents/report/annual-accounts-financial-year-2013_en.pdf"},
    {"id":"22583","name":"EU/3/08/605: Public summary of positive opinion for orphan designation of recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/k class for the treatment of spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2019-10-16T16:00:00Z","reference_number":"EMEA/COMP/623774/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308605-public-summary-positive-opinion-orphan-designation-recombinant-human-monoclonal-antibody-human-nogo-protein-igg4k-class-treatment-spinal-cord-injury_en.pdf"},
    {"id":"22584","name":"EU/3/17/1894: Public summary of opinion on orphan designation: recombinant human antibody directed against misfolded human superoxide dismutase 1 for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-09-13T11:28:00Z","last_updated_date":"2017-09-13T11:28:00Z","reference_number":"EMA/395085/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171894-public-summary-opinion-orphan-designation-recombinant-human-antibody-directed-against-misfolded-human-superoxide-dismutase-1-treatment-amyotrophic-lateral-sclerosis_en.pdf-0"},
    {"id":"22585","name":"Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Erbitux","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-11-20T00:09:21Z","last_updated_date":"2009-11-20T00:09:21Z","reference_number":"EMEA/CHMP/748861/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-erbitux_sv.pdf"}},
    {"id":"22586","name":"Opinion of the CVMP on the establishment of maximum residue limits: Tylvalosin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-09-09T18:15:00Z","last_updated_date":"2015-09-09T18:15:00Z","reference_number":"EMA/CVMP/380629/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-tylvalosin_en.pdf"},
    {"id":"22587","name":"Sandimmun Neoral Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-01-30T11:10:00Z","last_updated_date":"2014-01-30T11:10:00Z","reference_number":"EMA/589501/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/sandimmun-neoral-article-30-referral-assessment-report_en.pdf"},
    {"id":"22589","name":"CHMP summary of positive opinion for Zoledronic acid Teva Pharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T13:00:00Z","last_updated_date":"2018-12-12T13:00:00Z","reference_number":"EMA/176371/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zoledronic-acid-teva-pharma_en.pdf"},
    {"id":"22593","name":"Corlentor and Procoralan Article-20 procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-02-06T16:30:00Z","last_updated_date":"2015-02-06T16:30:00Z","reference_number":"EMA/734305/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/corlentor-and-procoralan-article-20-procedure-prac-assessment-report_en.pdf"},
    {"id":"22594","name":"Opinion following an Article 29(4) referral for Alendronate HEXAL and associated names International Non-Proprietary Name (INN): alendronic acid (as sodium alendronate trihydrate): Background 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    {"id":"22595","name":"Presentation - Variations & worksharing - an industry perspective (Rà©mon van Aubel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-variations-worksharing-industry-perspective-racmon-van-aubel_en.pdf"},
    {"id":"22598","name":"EU/3/15/1590: Public summary of opinion on orphan designation: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 for the treatment of Merkel cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2019-10-15T01:00:00Z","reference_number":"EMA/COMP/778956/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151590-public-summary-opinion-orphan-designation-recombinant-human-monoclonal-igg1-antibody-against-programmed-death-ligand-1-treatment-merkel-cell-carcinoma_en.pdf"},
    {"id":"22600","name":"Potential biomarkers to be used for osteoporosis drug development - Dominique Ethgen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/potential-biomarkers-be-used-osteoporosis-drug-development-dominique-ethgen_en.pdf"},
    {"id":"22601","name":"Opinion of the HMPC on a European Union herbal monograph on Calendula officinalis L., flos - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-06-14T15:00:00Z","last_updated_date":"2018-06-14T15:00:00Z","reference_number":"EMA/HMPC/195714/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-calendula-officinalis-l-flos-revision-1_en.pdf"},
    {"id":"22603","name":"Hexaflumuron (Fin fish): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-09-08T16:35:00Z","last_updated_date":"2015-09-08T16:35:00Z","reference_number":"EMA/CVMP/347671/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hexaflumuron-fin-fish-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"22605","name":"Recent experience in non-clinical assessment: Scientific advice and marketing authorization applications - Beatriz Silva Lima","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/recent-experience-non-clinical-assessment-scientific-advice-and-marketing-authorization-applications-beatriz-silva-lima_en.pdf"},
    {"id":"22611","name":"EU/3/04/234: Public summary of positive opinion for orphan designation of sitaxentan sodium for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:00:00Z","last_updated_date":"2016-09-30T12:00:00Z","reference_number":"EMEA/COMP/69492/04 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304234-public-summary-positive-opinion-orphan-designation-sitaxentan-sodium-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"22612","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with launch of public consultation of module VII revision 1, final module X and revision of module VIII, new annexes and final G...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-25T12:00:00Z","last_updated_date":"2013-04-25T12:00:00Z","reference_number":"EMA/237383/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-launch-public-consultation-module-vii-revision-1-final-module-x-and-revision-module-viii-new-annexes-and-final-g_en.pdf"},
    {"id":"22613","name":"Presentation - Pharmacometrics: a solid scientific basis for pharmacostatistical dose finding (Mick Looby)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacometrics-solid-scientific-basis-pharmacostatistical-dose-finding-mick-looby_en.pdf"},
    {"id":"22614","name":"Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-08T15:30:00Z","last_updated_date":"2018-03-08T15:37:00Z","reference_number":"EMA/152483/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-sulphate-sodium-sulphate-potassium-sulphate-list-nationally-authorised-medicinal-products-psusa00010239201708_en.pdf"},
    {"id":"22616","name":"Draft guideline on Allergen products: Production and quality issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2007-09-20T02:00:00Z","reference_number":"EMEA/CHMP/BWP/304831/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-allergen-products-production-and-quality-issues_en.pdf"},
    {"id":"22618","name":"EU/3/12/978: Public summary of opinion on orphan designation: Melatonin for the treatment of perinatal asphyxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-04-30T02:00:00Z","reference_number":"EMA/COMP/142943/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312978-public-summary-opinion-orphan-designation-melatonin-treatment-perinatal-asphyxia_en.pdf"},
    {"id":"22620","name":"Presentation - Irish Medicines Board: Considerations for veterinary scientific advice and marketing authorisations (Mary O’Grady)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-irish-medicines-board-considerations-veterinary-scientific-advice-and-marketing-authorisations-mary-ogrady_en.pdf"},
    {"id":"22622","name":"EU/3/16/1731 : Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against delta-aminolevulinic acid synthase 1 mRNA, covalently linked to a ligand containing three N...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-11T02:00:00Z","last_updated_date":"2016-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161731-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-delta-aminolevulinic-acid-synthase-1-mrna-covalently-linked-ligand-containing-three_en.pdf"},
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    {"id":"22629","name":"EU/3/05/346: Public summary of positive opinion for orphan designation of E. Coli heat-shock protein 70 with bovine retinal S-antigen for the treatment of autoimmune uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-08-08T02:00:00Z","last_updated_date":"2006-08-08T02:00:00Z","reference_number":"EMEA/COMP/414021/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305346-public-summary-positive-opinion-orphan-designation-e-coli-heat-shock-protein-70-bovine-retinal-s-antigen-treatment-autoimmune-uveitis_en.pdf"},
    {"id":"22630","name":"Questions and answers on the withdrawal of the marketing authorisation application for SecreFlo (secretin human)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-09-24T02:00:00Z","last_updated_date":"2012-09-24T02:00:00Z","reference_number":"EMA/CHMP/602611/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-secreflo-secretin-human_sv.pdf"}},
    {"id":"22631","name":"Iclusig Article-20 procedure - European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/641476/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-european-medicines-agency-recommends-further-measures-minimise-risk-blood-vessel-blockage-iclusig_en.pdf"},
    {"id":"22632","name":"Final community herbal monograph on Taraxacum officinale Weber ex Wigg., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-28T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/HMPC/212895/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-taraxacum-officinale-weber-ex-wigg-folium_en.pdf"},
    {"id":"22633","name":"EU/3/16/1618: Public summary of opinion on orphan designation: N-(4-Methoxyphenyl)-N,2,6-trimethylfuro[2,3-d]pyrimidin-4-amine for treatment of glioma for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/COMP/72380/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161618-public-summary-opinion-orphan-designation-n-4-methoxyphenyl-n26-trimethylfuro23-dpyrimidin-4-amine-treatment-glioma-treatment-glioma_en.pdf"},
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    {"id":"22637","name":"EU/3/14/1305: Public summary of opinion on orphan designation: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F for the treatment of...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T02:00:00Z","last_updated_date":"2019-10-15T02:00:00Z","reference_number":"EMA/COMP/363867/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141305-public-summary-opinion-orphan-designation-humanised-recombinant-monoclonal-antibody-against-epidermal-growth-factor-receptor-conjugated-maleimidocaproyl-monomethylauristatin-f-treatment_en.pdf"},
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    {"id":"22679","name":"Medical Dictionary for Regulatory Activities (MedDRA) Update - Patricia Mozzicato","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/medical-dictionary-regulatory-activities-meddra-update-patricia-mozzicato_en.pdf"},
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    {"id":"22683","name":"Final assessment report on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-07-10T14:00:00Z","last_updated_date":"2012-07-10T14:00:00Z","reference_number":"EMA/HMPC/337067/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-or-their-mixtures-flos-first-version_en.pdf"},
    {"id":"22684","name":"Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOS) (module 1.6.2)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-01-20T01:00:00Z","last_updated_date":"2005-01-20T01:00:00Z","reference_number":"EMEA/CHMP/BWP/135148/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/environmental-risk-assessments-medicinal-products-containing-or-consisting-genetically-modified-organisms-gmos-module-162_en.pdf"},
    {"id":"22685","name":"Public statement on Clopidogrel Teva Generics B.V.: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T16:00:00Z","last_updated_date":"2014-06-13T16:00:00Z","reference_number":"EMA/280867/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-teva-generics-bv-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"22687","name":"Trimetazidine: List of nationally authorised medicinal products - PSUSA/00003043/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T14:00:00Z","last_updated_date":"2016-10-17T20:16:38Z","reference_number":"EMA/245349/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/trimetazidine-list-nationally-authorised-medicinal-products-psusa00003043201508_en.pdf"},
    {"id":"22688","name":"European Medicines Agency 2011 priorities for drug safety research: Epoetins and tumour progression, shortened survival, mortality and thromboembolic events","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-07-08T02:00:00Z","last_updated_date":"2010-07-08T02:00:00Z","reference_number":"EMA/425285/2010","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-2011-priorities-drug-safety-research-epoetins-and-tumour-progression-shortened-survival-mortality-and-thromboembolic-events_en.pdf"},
    {"id":"22689","name":"Committee for proprietary medicinal products July 2001 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2001-07-31T02:00:00Z","last_updated_date":"2001-07-31T02:00:00Z","reference_number":"CPMP/2358/01","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-july-2001-plenary-meeting-monthly-report_en.pdf"},
    {"id":"22692","name":"Peer reviewers comments at day 100","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-07-03T16:30:00Z","last_updated_date":"2017-07-03T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/peer-reviewers-comments-day-100_en.docx"},
    {"id":"22696","name":"Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T14:10:00Z","last_updated_date":"2013-10-25T14:10:00Z","reference_number":"EMA/640658/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-solutions-hes-should-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients-cmdh-endorses-prac-recommendations_en.pdf"},
    {"id":"22697","name":"Superseded list of references supporting the assessment of Orthosiphon stamineus Benth., folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-05-30T02:00:00Z","last_updated_date":"2011-05-30T02:00:00Z","reference_number":"EMA/HMPC/281529/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-orthosiphon-stamineus-benth-folium_en.pdf"},
    {"id":"22698","name":"EU/3/17/1888: Public summary of opinion on orphan designation: Tripotassium citrate monohydrate and potassium hydrogen carbonate for the treatment of distal renal tubular acidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/333697/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171888-public-summary-opinion-orphan-designation-tripotassium-citrate-monohydrate-and-potassium-hydrogen-carbonate-treatment-distal-renal-tubular-acidosis_en.pdf"},
    {"id":"22702","name":"European Union recommendation for the emergent-novel-H1N1-influenza-vaccine composition - Revised to include strain IVR-153","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:09:21Z","last_updated_date":"2009-06-10T02:09:21Z","reference_number":"EMEA/CHMP/BWP/340831/2009/Rev 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-recommendation-emergent-novel-h1n1-influenza-vaccine-composition-revised-include-strain-ivr-153_en.pdf"},
    {"id":"22704","name":"Amlodipine: List of nationally authorised medicinal products - PSUSA/00000174/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-20T13:00:00Z","last_updated_date":"2017-11-20T13:00:00Z","reference_number":"EMA/764352/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-list-nationally-authorised-medicinal-products-psusa00000174201703_en.pdf"},
    {"id":"22705","name":"EU/3/15/1497: Public summary of opinion on orphan designation: 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for the treatment of Huntington’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/COMP/276402/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151497-public-summary-opinion-orphan-designation-57-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline-hydrochloride-treatment-huntingtons-disease_en.pdf"},
    {"id":"22709","name":"Euro Nippon Kayaku GmbH withdraws its marketing authorisation\n\napplication for Spanidin (gusperimus)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-19T02:09:21Z","last_updated_date":"2008-06-19T02:09:21Z","reference_number":"EMEA/CHMP/323118/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/euro-nippon-kayaku-gmbh-withdraws-its-marketing-authorisation-application-spanidin-gusperimus_en.pdf"},
    {"id":"22713","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M3 (R2) questions and answers - Step 5","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-07-25T02:00:00Z","last_updated_date":"2012-05-25T15:45:00Z","reference_number":"EMA/CHMP/ICH/507008/2011","document_url":"https://www.ema.europa.eu/en/documents/other/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-m3-r2-questions-and-answers-step-5_en.pdf"},
    {"id":"22714","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 16-19 September 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-26T17:35:00Z","last_updated_date":"2013-09-26T17:35:00Z","reference_number":"EMA/568771/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-16-19-september-2013_en.pdf"},
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    {"id":"22719","name":"Withdrawal assessment report for Vorinostat MSD","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/CHMP/559066/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-vorinostat-msd_en.pdf"},
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    {"id":"22724","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Mother Infant Child Youth Research Network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817621/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-mother-infant-child-youth-research-network_en.pdf"},
    {"id":"22726","name":"Presentation - Efpia survey on impact of the paediatric regulation on\n\nmarketing authorization holders (Jan 2007 – Jun 2010)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-efpia-survey-impact-paediatric-regulation-marketing-authorization-holders-jan-2007-jun-2010_en.pdf"},
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    {"id":"22729","name":"Dihydroergotoxine: List of nationally authorised medicinal products - PSUSA/00001079/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-15T13:00:00Z","last_updated_date":"2016-10-17T19:52:26Z","reference_number":"EMA/842655/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/dihydroergotoxine-list-nationally-authorised-medicinal-products-psusa00001079201504_en.pdf"},
    {"id":"22731","name":"Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T16:35:00Z","last_updated_date":"2012-11-23T16:35:00Z","reference_number":"EMA/590745/2012","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-medicinal-product-supply-shortages-caused-manufacturing-good-manufacturing-practice-compliance-problems_en.pdf"},
    {"id":"22732","name":"Committee for Proprietary Medicinal Products (CPMP) 61st plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-07-04T02:00:00Z","last_updated_date":"2000-07-04T02:00:00Z","reference_number":"CPMP/1586/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-61st-plenary-meeting_en.pdf"},
    {"id":"22735","name":"Scientific recommendation on classification of advanced therapy medicinal products: AAV vector carrying an expression cassette for photoactivable enhanced halorhodopsin protein from Natronomonas pharaonis (eNpHR)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:00:00Z","last_updated_date":"2015-08-26T12:00:00Z","reference_number":"EMA/556494/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-aav-vector-carrying-expression-cassette-photoactivable-enhanced-halorhodopsin-protein-natronomonas-pharaonis-enphr_en.pdf"},
    {"id":"22736","name":"Final assessment report on Taraxacum officinale Weber ex Wigg., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/HMPC/579634/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-taraxacum-officinale-weber-ex-wigg-folium_en.pdf"},
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    {"id":"22741","name":"Human adult allogenic mesodermal progenitor cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2016-05-04T13:00:00Z","reference_number":"EMA/291903/2016","document_url":"https://www.ema.europa.eu/en/documents/report/human-adult-allogenic-mesodermal-progenitor-cells_en.pdf"},
    {"id":"22742","name":"Agenda - Programme - EU 28: science, medicines, health","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-02-06T12:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-eu-28-science-medicines-health_en.pdf"},
    {"id":"22743","name":"European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-10-24T02:00:00Z","last_updated_date":"2001-10-24T02:00:00Z","reference_number":"EMA/641476/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-further-measures-minimise-risk-blood-vessel-blockage-iclusig_en.pdf"},
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    {"id":"22748","name":"Presentation - Streamlined procedure for evaluation of eligibility criteria of patients' and consumers' organisations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-streamlined-procedure-evaluation-eligibility-criteria-patients-and-consumers-organisations_en.pdf"},
    {"id":"22749","name":"EU/3/13/1177: Public summary of opinion on orphan designation: Chimaeric monoclonal antibody against claudin-18 splice variant 2 for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-13T02:00:00Z","last_updated_date":"2013-09-13T02:00:00Z","reference_number":"EMA/COMP/438204/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131177-public-summary-opinion-orphan-designation-chimaeric-monoclonal-antibody-against-claudin-18-splice-variant-2-treatment-pancreatic-cancer_en.pdf"},
    {"id":"22750","name":"Questions and answers on the refusal of a change to the marketing authorisation for Raxone (idebenone)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/613204/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-raxone-idebenone_en.pdf"},
    {"id":"22752","name":"Presentation - Specific aspects concerning GMP and GCP inspections in Accelerated Assessment procedures (Andrei Spinei, Sophia Mylona)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-specific-aspects-concerning-gmp-and-gcp-inspections-accelerated-assessment-procedures-andrei-spinei-sophia-mylona_en.pdf"},
    {"id":"22754","name":"Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells suspension extracted from bone (Ilium) marrow and cultivated during 18 days","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-11-08T10:45:00Z","last_updated_date":"2013-11-08T10:45:00Z","reference_number":"EMA/660945/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-mesenchymal-stem-cells-suspension-extracted-bone-ilium-marrow-and-cultivated-during-18-days_en.pdf"},
    {"id":"22755","name":"Juniperi fructus: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/562/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/juniperi-fructus-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"22756","name":"CHMP ORGAM agenda for the meeting on 12 June 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-06-16T19:30:00Z","last_updated_date":"2017-06-16T19:30:00Z","reference_number":"EMA/CHMP/371261/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-12-june-2017_en.pdf"},
    {"id":"22758","name":"CHMP statistics: September 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-september-2016_en.pdf"},
    {"id":"22759","name":"EU/3/11/852: Public summary of positive opinion for orphan designation:  Human anthrax monoclonal antibody for the treatment of inhalation anthrax disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2016-08-11T02:00:00Z","reference_number":"EMA/COMP/65174/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311852-public-summary-positive-opinion-orphan-designation-human-anthrax-monoclonal-antibody-treatment-inhalation-anthrax-disease_en.pdf"},
    {"id":"22761","name":"Okrido Article-29 referral - CHMP assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-01-03T01:00:00Z","last_updated_date":"2014-01-03T01:00:00Z","reference_number":"EMA/597619/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/okrido-article-29-referral-chmp-assessment-report_en.pdf"},
    {"id":"22763","name":"Annex I: Catalogue-2016 donation of IT assets","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-29T12:45:00Z","last_updated_date":"2016-07-29T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-i-catalogue-2016-donation-it-assets_en.xlsx"},
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    {"id":"22770","name":"Tyverb: Withdrawal letter","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-16T01:00:00Z","last_updated_date":"2012-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/tyverb-withdrawal-letter_en.pdf"},
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    {"id":"22778","name":"Public statement on Exubera (insulin human) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-11-10T00:09:21Z","last_updated_date":"2008-11-10T00:09:21Z","reference_number":"EMEA/557896/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-exubera-insulin-human-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"22779","name":"Presentation - Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals Working Party (HCPWP) feedback from CHMP (H. Enzmann, C. Prieto and D. Duarte)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-working-party-hcpwp-feedback-chmp-h-enzmann-c-prieto-and-d-duarte_en.pdf"},
    {"id":"22781","name":"CHMP post-authorisation summary of positive opinion for Jardiance","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/398392/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jardiance_en.pdf"},
    {"id":"22782","name":"Presentation - PML Final Conclusions, Peter Arlett","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pml-final-conclusions-peter-arlett_en.pdf"},
    {"id":"22784","name":"EU/3/01/048: Public summary of positive opinion for orphan designation of ziconotide (intraspinal use) for the treatment of chronic pain requiring intraspinal analgesia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2015-05-08T02:00:00Z","reference_number":"EMEA/COMP/252/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301048-public-summary-positive-opinion-orphan-designation-ziconotide-intraspinal-use-treatment-chronic-pain-requiring-intraspinal-analgesia_en.pdf"},
    {"id":"22787","name":"Work plan for Good Clinical Practice Inspectors Working Group 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2018-03-22T14:00:00Z","last_updated_date":"2018-03-22T14:00:00Z","reference_number":"EMA/87812 /2018","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-good-clinical-practice-inspectors-working-group-2018_en.pdf"},
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    {"id":"22790","name":"Draft list of references for assessment of: Althaeae radix Althaea officinalis L., radix (marshmallow root)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2008-07-03T02:09:21Z","reference_number":"EMEA/HMPC/98716/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-althaeae-radix-althaea-officinalis-l-radix-marshmallow-root_en.pdf"},
    {"id":"22793","name":"Registration form - 2017 Annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-02-09T15:00:00Z","last_updated_date":"2017-02-09T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-2017-annual-workshop-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"22794","name":"Agenda - European Medicines Agency-EuropaBio information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T01:00:00Z","last_updated_date":"2016-11-25T16:35:00Z","reference_number":"EMA/723535/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-europabio-information-day_en.pdf-0"},
    {"id":"22795","name":"Committee for Advanced Therapies (CAT): July 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-07-21T02:00:00Z","last_updated_date":"2011-07-21T02:00:00Z","reference_number":"EMA/CAT/576474/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-july-2011-meeting-monthly-report_en.pdf"},
    {"id":"22796","name":"Introduction of AESGP","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-aesgp_en.pdf"},
    {"id":"22797","name":"EU/3/14/1341: Public summary of opinion on orphan designation: Cysteamine hydrochloride for the treatment of cystinosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/552795/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141341-public-summary-opinion-orphan-designation-cysteamine-hydrochloride-treatment-cystinosis_en.pdf"},
    {"id":"22798","name":"Agenda - Meeting on monitoring of sales of veterinary antimicrobial agents in Europe","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-11-12T01:00:00Z","last_updated_date":"2009-11-12T01:00:00Z","reference_number":"EMEA/419053/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-meeting-monitoring-sales-veterinary-antimicrobial-agents-europe_en.pdf"},
    {"id":"22799","name":"Annual reports for the period from 2012 to 2015 on staff engaging in an occupational activity within two years of leaving the service (article 16 of the staff regulations)","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2014-05-07T02:00:00Z","last_updated_date":"2016-08-22T13:05:00Z","reference_number":"EMA/302717/2015","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-reports-period-2012-2015-staff-engaging-occupational-activity-within-two-years-leaving-service-article-16-staff-regulations_en.pdf"},
    {"id":"22801","name":"List of meetings, workshops and training activities planned by the European Medicines Agency for human and veterinary medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-08-17T02:00:00Z","last_updated_date":"2009-08-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-meetings-workshops-and-training-activities-planned-european-medicines-agency-human-and-veterinary-medicines_en.pdf"},
    {"id":"22803","name":"Monepantel (caprine and ovine milk): European public maximum-residue-limit assessment report (4) (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-05-24T13:15:00Z","last_updated_date":"2013-05-24T13:15:00Z","reference_number":"EMA/CVMP/741250/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/monepantel-caprine-and-ovine-milk-european-public-maximum-residue-limit-assessment-report-4-epmar-cvmp_en.pdf"},
    {"id":"22805","name":"Overview of comments received on European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T02:00:00Z","last_updated_date":"2016-03-30T02:00:00Z","reference_number":"EMA/HMPC/278488/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"22806","name":"Agenda - CAT agenda of the 15-17 February 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-02-21T17:50:00Z","last_updated_date":"2017-02-21T17:50:00Z","reference_number":"EMA/CAT/126633/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-17-february-2017-meeting_en.pdf"},
    {"id":"22807","name":"Committee for Proprietary Medicinal Products (CPMP) 30th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-09-25T02:00:00Z","last_updated_date":"1997-09-25T02:00:00Z","reference_number":"CPMP/813/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-30th-plenary-meeting_en.pdf"},
    {"id":"22809","name":"Presentation - An approach to outcome measure development - a regulatory perspective (Elektra Papadopoulos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-approach-outcome-measure-development-regulatory-perspective-elektra-papadopoulos_en.pdf"},
    {"id":"22810","name":"Letter of withdrawal of application for the GlaxoSmithKline Biologicals S.A. Globorix vaccine (DTPw-HBV/Hib-MenAC, powder and suspension for suspension for injection) - EMEA/H/W/848","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-17T02:09:00Z","last_updated_date":"2007-10-17T02:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-withdrawal-application-glaxosmithkline-biologicals-sa-globorix-vaccine-dtpw-hbvhib-menac-powder-and-suspension-suspension-injection-emeahw848_en.pdf"},
    {"id":"22813","name":"Committee for Orphan Medicinal Products: October 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-10-25T02:00:00Z","last_updated_date":"2005-10-25T02:00:00Z","reference_number":"EMEA/COMP/354440/2005corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-october-2005-meeting_en.pdf"},
    {"id":"22815","name":"Draft assessment report on Marrubium vulgare L., herba - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-01-28T01:00:00Z","last_updated_date":"2013-01-28T01:00:00Z","reference_number":"EMA/HMPC/604273/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-marrubium-vulgare-l-herba-first-version_en.pdf"},
    {"id":"22818","name":"Presentation - Day 2: Prevention of corneal graft rejection: clinical view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-prevention-corneal-graft-rejection-clinical-view_en.pdf"},
    {"id":"22822","name":"Presentation - A historical overview of the therapeutic use of bacteriophages (Andrzej Gorski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-historical-overview-therapeutic-use-bacteriophages-andrzej-gorski_en.pdf"},
    {"id":"22823","name":"Meeting report on the paediatric high-grade glioma medicines expert workshop","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-07-06T02:00:00Z","last_updated_date":"2011-07-06T02:00:00Z","reference_number":"EMA/289125/2011","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-paediatric-high-grade-glioma-medicines-expert-workshop_en.pdf"},
    {"id":"22824","name":"Presentation - Study of liver function monitoring in patients receiving agomelatine in the EHI database (Maia Uuskula)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-study-liver-function-monitoring-patients-receiving-agomelatine-ehi-database-maia-uuskula_en.pdf"},
    {"id":"22825","name":"Presentation - Post designation and orphan medicines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-17T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-post-designation-and-orphan-medicines_en.pdf"},
    {"id":"22826","name":"Guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-03-30T02:00:00Z","last_updated_date":"2006-03-30T02:00:00Z","reference_number":"CPMP/QWP/2819/00 Rev 1 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-herbal-medicinal-productstraditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"22828","name":"Altrenogest - Article 35 referral - Annexes I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-09-08T02:00:00Z","reference_number":"EMEA/V/A/095","document_url":"https://www.ema.europa.eu/en/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/altrenogest-article-35-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"22829","name":"Presentation - Traditional validation: Downstream (Marco Strohmeier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-traditional-validation-downstream-marco-strohmeier_en.pdf"},
    {"id":"22831","name":"EU/3/04/253: Public summary of positive opinion for orphan designation of Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-06T00:00:00Z","last_updated_date":"2009-11-19T00:00:00Z","reference_number":"EMEA/COMP/152720/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304253-public-summary-positive-opinion-orphan-designation-val-leu-gln-glu-leu-asn-val-thr-val-pr1-nanopeptide-sequence-169-177-proteinase-3-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"22832","name":"Agenda - First European Medicines Agency-EuropaBio annual bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-30T13:00:00Z","last_updated_date":"2017-05-30T13:00:00Z","reference_number":"EMA/326145/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-european-medicines-agency-europabio-annual-bilateral-meeting_en.pdf"},
    {"id":"22833","name":"Reflection paper on control of the active substance in the finished product for immunological veterinary medicinal products (IVMPs)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-03-18T01:00:00Z","last_updated_date":"2010-03-18T01:00:00Z","reference_number":"EMA/CVMP/IWP/582970/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-control-active-substance-finished-product-immunological-veterinary-medicinal-products-ivmps_en.pdf"},
    {"id":"22835","name":"Questions and answers relating to tender – EMA-2012-09-IF External service providers for enterprise infrastructure support: provision of resources for Oracle database and middleware product management","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-14T13:00:00Z","last_updated_date":"2012-04-12T15:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-tender-ema-2012-09-if-external-service-providers-enterprise-infrastructure-support-provision-resources-oracle-database-and-middleware-product-management_en.pdf"},
    {"id":"22836","name":"Annex XIII - List of Valproate and related substances in the European Union","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2015-01-28T10:00:00Z","last_updated_date":"2023-04-26T11:10:00Z","reference_number":"EMA/11799/2015 Corr. 5","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-xiii-list-valproate-and-related-substances-european-union_en.xlsx"},
    {"id":"22838","name":"EU/3/18/2039: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype 9 containing human iduronidase gene for the treatment of mucopolysaccharidosis type I","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-22T11:49:00Z","last_updated_date":"2018-08-22T11:49:00Z","reference_number":"EMA/373289/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182039-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-9-containing-human-iduronidase-gene-treatment-mucopolysaccharidosis-type-i_en.pdf"},
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    {"id":"22841","name":"CHMP summary of positive opinion for Sabervel","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2012-02-17T01:00:00Z","reference_number":"EMA/CHMP/101946/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sabervel_en.pdf"},
    {"id":"22842","name":"Ciprofloxacin Kabi  - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-02-06T00:08:21Z","last_updated_date":"2007-02-06T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ciprofloxacin-kabi-article-29-referral-annex-i-ii-iii_fi.pdf"}},
    {"id":"22843","name":"Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients – CMDh endorses PRAC recommendations","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T14:10:00Z","last_updated_date":"2013-10-25T14:10:00Z","reference_number":"EMA/640658/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-solutions-hes-should-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients-cmdh-endorses-prac-recommendations_en.pdf-0"},
    {"id":"22844","name":"Presentation - General discussion, summing up and way forward - Session 6 (Brian Dooley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-discussion-summing-and-way-forward-session-6-brian-dooley_en.pdf"},
    {"id":"22846","name":"Codeine Article-31 referral – Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-05T14:00:00Z","last_updated_date":"2012-10-05T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-notification_en.pdf-0"},
    {"id":"22847","name":"Antithrombin iii: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00003159/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-24T16:57:00Z","last_updated_date":"2016-10-25T11:36:27Z","reference_number":"EMA/694889/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/antithrombin-iii-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00003159201512_en.pdf"},
    {"id":"22849","name":"EU/3/06/419: Public summary of positive opinion for orphan designation of paclitaxel (liposomal) for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/177295/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306419-public-summary-positive-opinion-orphan-designation-paclitaxel-liposomal-treatment-pancreatic-cancer_en.pdf"},
    {"id":"22853","name":"Day 120 list of questions template rev. 10.17","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-05-21T12:00:00Z","last_updated_date":"2017-12-01T17:28:00Z","reference_number":"D120 list of questions rev. 10.17","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-120-list-questions-template-rev-1017_en.docx"},
    {"id":"22856","name":"EU/3/02/119: Public summary of positive opinion for orphan designation of iodine (131I) anti-nucleohistone H1 chimeric biotinylated monoclonal antibody for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-05-26T02:00:00Z","last_updated_date":"2016-10-20T02:00:00Z","reference_number":"EMEA/COMP/2410/02/Rev 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302119-public-summary-positive-opinion-orphan-designation-iodine-131i-anti-nucleohistone-h1-chimeric-biotinylated-monoclonal-antibody-treatment-glioma_en.pdf"},
    {"id":"22859","name":"Clodronic acid (in the form of disodium salt) (Equidae): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-09-08T16:35:00Z","last_updated_date":"2015-09-08T16:35:00Z","reference_number":"EMA/CVMP/239233/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/clodronic-acid-form-disodium-salt-equidae-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"22861","name":"EU/3/14/1342: Public summary of opinion on orphan designation: Glucagon for the treatment of congenital hyperinsulinism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/546576/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141342-public-summary-opinion-orphan-designation-glucagon-treatment-congenital-hyperinsulinism_en.pdf"},
    {"id":"22863","name":"Presentation - Levels of evidence in drug development: Paediatric dose selection for fondaparinux","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:30:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-levels-evidence-drug-development-paediatric-dose-selection-fondaparinux_en.pdf"},
    {"id":"22864","name":"Agenda and registration form - EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area (Spain, Dec 2015)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-09-21T02:00:00Z","last_updated_date":"2015-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-european-economic-area-spain-dec-2015_en.pdf"},
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    {"id":"22887","name":"PDCO dates for 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-26T01:00:00Z","last_updated_date":"2011-04-20T02:00:00Z","reference_number":"EMA/PDCO/70198/2010","document_url":"https://www.ema.europa.eu/en/documents/other/pdco-dates-2012_en.pdf"},
    {"id":"22889","name":"Frank W. Rockhold  (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-09-05T18:01:00Z","last_updated_date":"2017-09-05T18:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/frank-w-rockhold-doi_en.pdf"},
    {"id":"22890","name":"Declaration of interest: Sebastian Asprella","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2017-08-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interest-sebastian-asprella_en.pdf"},
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    {"id":"22911","name":"Presentation - Overview of reflection paper on promotion of pharmacovigilance reporting (L.Woods)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-reflection-paper-promotion-pharmacovigilance-reporting-lwoods_en.pdf"},
    {"id":"22914","name":"Presentation - Diagnostics: A focus on use in development of drugs for multiple drug resistant (MDR) pathogens (John Rex)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-diagnostics-focus-use-development-drugs-multiple-drug-resistant-mdr-pathogens-john-rex_en.pdf"},
    {"id":"22915","name":"Advanced therapy medicinal products: Full applications (first phase)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/advanced-therapy-medicinal-products-full-applications-first-phase_en.pdf"},
    {"id":"22917","name":"Presentation - Feedback from COMP (D. O'Connor, COMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-comp-d-oconnor-comp_en.pdf"},
    {"id":"22919","name":"Corticorelin: CMDh Scientific conclusions and grounds for variation,\n\namendments to the product information, and timetable\n\nfor the implementation - PSUSA/00000876/201410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T14:00:00Z","last_updated_date":"2016-10-17T20:37:51Z","reference_number":"EMA/539540/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/corticorelin-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000876201410_en.pdf"},
    {"id":"22923","name":"Committee for Medicinal Products for Human Use positive summary of opinion for Humenza","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-02-19T01:00:00Z","last_updated_date":"2011-06-30T02:00:00Z","reference_number":"EMA/CHMP/31616/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-positive-summary-opinion-humenza_en.pdf"},
    {"id":"22924","name":"Minutes - Ninth industry stakeholder platform on the operation of EU pharmacovigilance (highlights)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T01:00:00Z","last_updated_date":"2017-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ninth-industry-stakeholder-platform-operation-eu-pharmacovigilance-highlights_en.pdf"},
    {"id":"22926","name":"Osteoporosis - Regulatory perspective - Frits Lekkerkerker","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/osteoporosis-regulatory-perspective-frits-lekkerkerker_en.pdf"},
    {"id":"22927","name":"CHMP summary of positive opinion for Duavive","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T14:00:00Z","last_updated_date":"2014-10-24T14:00:00Z","reference_number":"EMA/CHMP/654571/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-duavive_en.pdf"},
    {"id":"22928","name":"EU/3/11/885: Public summary of opinion on orphan designation: Mixture of seven synthetic fragments consisting of p21 RAS peptides for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2011-08-16T02:00:00Z","reference_number":"EMA/COMP/404700/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311885-public-summary-opinion-orphan-designation-mixture-seven-synthetic-fragments-consisting-p21-ras-peptides-treatment-pancreatic-cancer_en.pdf"},
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    {"id":"22931","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 20-22 May 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-06-05T17:10:00Z","last_updated_date":"2015-06-05T17:10:00Z","reference_number":"EMA/PDCO/348974/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-20-22-may-2015_en.pdf"},
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    {"id":"22933","name":"European Medicines Agency update on Diane 35 and generics used in the treatment of acne","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-01-30T22:00:00Z","last_updated_date":"2013-01-31T11:00:00Z","reference_number":"EMA/65929/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-update-diane-35-and-generics-used-treatment-acne_en.pdf"},
    {"id":"22934","name":"CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T13:00:00Z","last_updated_date":"2014-04-09T14:00:00Z","reference_number":"EMA/781158/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/chmp-confirms-prac-recommendations-kogenate-bayerhelixate-nexgen_sv.pdf"}},
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    {"id":"23006","name":"Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T02:00:00Z","last_updated_date":"2017-08-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"23012","name":"Public statement on the expiry and withdrawal of the marketing authorisation in the European Union for Posaconazole SP","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-08-03T02:00:00Z","last_updated_date":"2009-08-03T02:00:00Z","reference_number":"EMEA/464490/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-expiry-and-withdrawal-marketing-authorisation-european-union-posaconazole-sp_en.pdf"},
    {"id":"23013","name":"CHMP summary of positive opinion for Cerdelga","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2014-11-21T01:00:00Z","reference_number":"EMA/CHMP/687220/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cerdelga_en.pdf"},
    {"id":"23014","name":"Ibuprofen and dexibuprofen Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-07-14T02:00:00Z","last_updated_date":"2015-07-14T02:00:00Z","reference_number":"EMA/348171/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-assessment-report_en.pdf"},
    {"id":"23017","name":"Poly (o-2-hydroxyethyl) starch: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0009","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-30T16:29:00Z","last_updated_date":"2017-10-30T16:29:00Z","reference_number":"EMA/723696/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/poly-o-2-hydroxyethyl-starch-list-nationally-authorised-medicinal-products-emeahnpsrs0009_en.pdf"},
    {"id":"23018","name":"Draft community herbal monograph on Verbascum thapsus L., V. densiflorum Bertol (V. thapsiforme Schrad), and V. phlomoides L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/395213/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-verbascum-thapsus-l-v-densiflorum-bertol-v-thapsiforme-schrad-and-v-phlomoides-l-flos_en.pdf"},
    {"id":"23020","name":"Presentation - Uncertainty quantification (Ine Skottheim Rusten)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-uncertainty-quantification-ine-skottheim-rusten_en.pdf"},
    {"id":"23023","name":"Guideline for the conduct of bioequivalence studies for veterinary medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-01-09T01:00:00Z","last_updated_date":"2001-01-09T01:00:00Z","reference_number":"EMEA/CVMP/016/00-cor-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-1_en.pdf"},
    {"id":"23025","name":"EU/3/13/1218: Public summary of opinion on orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2019-07-09T11:00:00Z","reference_number":"EMA/COMP/708390/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131218-public-summary-opinion-orphan-designation-recombinant-human-type-i-pancreatic-elastase-prevention-arteriovenous-access-dysfunction-haemodialysis-patients_en.pdf"},
    {"id":"23026","name":"Draft assessment report on Polygonum aviculare L., herba","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-10-19T12:50:00Z","last_updated_date":"2015-10-19T12:50:00Z","reference_number":"EMA/HMPC/143659/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-polygonum-aviculare-l-herba_en.pdf"},
    {"id":"23027","name":"Workshop report - Expert workshop on subgroup analysis","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"EMA/916257/2011","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-expert-workshop-subgroup-analysis_en.pdf"},
    {"id":"23029","name":"Committee for medicinal products for veterinary use: Meeting of 15-17 July 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-07-18T02:09:21Z","last_updated_date":"2008-07-18T02:09:21Z","reference_number":"EMEA/CVMP/355401/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-15-17-july-2008_en.pdf"},
    {"id":"23030","name":"High level business consultancy EMA/2013/23/FI - Technical specifications - Annex IV draft framework contract","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/high-level-business-consultancy-ema201323fi-technical-specifications-annex-iv-draft-framework-contract_en.pdf"},
    {"id":"23031","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Review started (updated communication)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-15T14:00:00Z","last_updated_date":"2016-04-15T14:00:00Z","reference_number":"EMA/263596/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-review-started-updated-communication_en.pdf"},
    {"id":"23034","name":"Meeting of the EMEA working party on herbal medicinal products 30 June and 1 July 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-07-09T02:00:00Z","last_updated_date":"2003-07-09T02:00:00Z","reference_number":"EMEA/HMPWP/3520/03 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-30-june-and-1-july-2003_en.pdf"},
    {"id":"23035","name":"Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (superseded)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-12-18T12:35:00Z","last_updated_date":"2022-02-04T12:35:00Z","reference_number":"EMA/INS/GCP/600788/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-interactive-response-technologies-interactive-voiceweb-response-systems-clinical-trials-particular-emphasis-handling-expiry-dates-superseded_en.pdf"},
    {"id":"23037","name":"Multinational assessment team concept - The next phase - Extending the concept to the post-authorisation 2nd phase","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-01-17T13:30:00Z","last_updated_date":"2023-04-14T15:21:00Z","reference_number":"EMA/619544/2016 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/multinational-assessment-team-concept-next-phase-extending-concept-post-authorisation-2nd-phase_en.pdf"},
    {"id":"23040","name":"Betaine Glucuronate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-02-01T01:00:00Z","last_updated_date":"1999-02-01T01:00:00Z","reference_number":"EMEA/MRL/568/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/betaine-glucuronate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"23041","name":"Presentation - Medicines and Healthcare products Regulatory Agency (MHRA): Overview of applications for Marketing Authorisations – recent experience in assessment of quality (Keith Pugh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-and-healthcare-products-regulatory-agency-mhra-overview-applications-marketing-authorisations-recent-experience-assessment-quality-keith-pugh_en.pdf"},
    {"id":"23042","name":"EU/3/18/2016: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 9 containing the human CLN1 gene for the treatment of neuronal ceroid lipofuscinosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T17:07:00Z","last_updated_date":"2018-07-23T17:07:00Z","reference_number":"EMA/270942/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182016-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-containing-human-cln1-gene-treatment-neuronal-ceroid-lipofuscinosis_en.pdf"},
    {"id":"23043","name":"Ethinylestradiol, gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-08T02:00:00Z","last_updated_date":"2016-10-18T13:55:57Z","reference_number":"EMA/666639/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethinylestradiol-gestodene-transdermal-application-list-nationally-authorised-medicinal-products-psusa00010145201502_en.pdf"},
    {"id":"23047","name":"Public statement on Sepioglin: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T15:45:00Z","last_updated_date":"2013-07-18T15:45:00Z","reference_number":"EMA/103518/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-sepioglin-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"23048","name":"CHMP ORGAM agenda for the meeting on 4 December 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-12-18T12:30:00Z","last_updated_date":"2017-12-18T12:30:00Z","reference_number":"EMA/800758/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-4-december-2017_en.pdf"},
    {"id":"23049","name":"CHMP summary of positive opinion for Levetiracetam ratiopharm","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/373851/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-levetiracetam-ratiopharm_en.pdf"},
    {"id":"23052","name":"EU/3/01/074: Public summary of positive opinion for orphan designation of halofuginone hydrobromide for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2009-06-15T02:00:00Z","reference_number":"EMEA/COMP/271/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301074-public-summary-positive-opinion-orphan-designation-halofuginone-hydrobromide-treatment-systemic-sclerosis_en.pdf"},
    {"id":"23053","name":"Agenda - Workshop on viral safety of plasma-derived medicinal products with respect to hepatitis E virus","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2014-07-28T13:40:00Z","last_updated_date":"2015-06-26T13:40:00Z","reference_number":"EMA/CHMP/BWP/196177/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-viral-safety-plasma-derived-medicinal-products-respect-hepatitis-e-virus_en.pdf"},
    {"id":"23056","name":"Agenda and registration form - Signal detection and management information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-11-21T18:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-signal-detection-and-management-information-day_en.pdf"},
    {"id":"23059","name":"Superseded list of references supporting the assessment on: Primulae radix Primula veris L. and Primula elatior (L.) Hill, radix (primula root)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-11-28T01:00:00Z","last_updated_date":"2008-11-28T01:00:00Z","reference_number":"EMEA/HMPC/111736/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-primulae-radix-primula-veris-l-and-primula-elatior-l-hill-radix-primula-root_en.pdf"},
    {"id":"23060","name":"Chlormadinone acetate / ethinylestradiol: List of nationally authorised medicinal products - PSUSA/00000679/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T17:10:00Z","last_updated_date":"2017-09-06T17:10:00Z","reference_number":"EMA/583978/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlormadinone-acetate-ethinylestradiol-list-nationally-authorised-medicinal-products-psusa00000679201611_en.pdf"},
    {"id":"23065","name":"Concept paper on revision of the current guideline on the SPC for antimicrobial products (EMEA/CVMP/612/01-FINAL)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-06-15T02:09:21Z","last_updated_date":"2005-06-15T02:09:21Z","reference_number":"EMEA/CVMP/67951/2005-CONSULTATION","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-current-guideline-spc-antimicrobial-products-emeacvmp61201-final_en.pdf"},
    {"id":"23067","name":"Update on seasonal-influenza vaccines produced by Novartis Vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-10-26T20:03:05Z","last_updated_date":"2012-10-26T20:03:05Z","reference_number":"EMA/696434/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-seasonal-influenza-vaccines-produced-novartis-vaccines_en.pdf"},
    {"id":"23068","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 21-24 September 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-09-30T17:10:00Z","last_updated_date":"2015-09-30T17:10:00Z","reference_number":"EMA/38595/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-during-chmp-meeting-21-24-september-2015_en.pdf"},
    {"id":"23073","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Adult autologous regenerative cells for subcutaneous administration","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T18:00:00Z","last_updated_date":"2013-05-03T18:00:00Z","reference_number":"EMA/129056/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adult-autologous-regenerative-cells-subcutaneous-administration_en.pdf"},
    {"id":"23074","name":"Initial notices for parallel distribution - March 2015","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-04-17T12:00:00Z","last_updated_date":"2015-04-17T12:00:00Z","reference_number":"EMA/245546/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-march-2015_en.pdf"},
    {"id":"23077","name":"Opinion following an Article 35 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, and related veterinary medicinal products: Background 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    {"id":"23149","name":"Questions and answers on the recommendation for the refusal of the marketing authorisation for Glybera","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/474562/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-glybera_en.pdf"},
    {"id":"23150","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-18 July 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-07-31T16:30:00Z","last_updated_date":"2017-07-31T16:30:00Z","reference_number":"EMA/HMPC/469476/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-17-18-july-2017_en.pdf"},
    {"id":"23157","name":"Presentation - Optimising early access tools: revision of the guidelines on Accelerated Assessment and Conditional Marketing Authorisation (Tomas Salmonson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T14:00:00Z","last_updated_date":"2015-11-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optimising-early-access-tools-revision-guidelines-accelerated-assessment-and-conditional-marketing-authorisation-tomas-salmonson_en.pdf"},
    {"id":"23159","name":"Human medicines highlights - July 2013","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2013-08-06T12:00:00Z","last_updated_date":"2013-08-06T12:00:00Z","reference_number":"Issue 54","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-july-2013_en.pdf"},
    {"id":"23160","name":"EU/3/12/1028: Public summary of opinion on orphan designation: (2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acet...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-08-30T18:40:00Z","last_updated_date":"2012-08-30T18:40:00Z","reference_number":"EMA/COMP/426291/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121028-public-summary-opinion-orphan-designation-2s-2-2r-2-33-dibutyl-7-methylthio-11-dioxido-5-phenyl-2345-tetrahydro-125-benzothiadiazepin-8-yloxyacetylamino-2-4-hydroxyphenylacet_en.pdf"},
    {"id":"23161","name":"Nineteenth pandemic pharmacovigilance update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-06-03T02:00:00Z","last_updated_date":"2010-06-03T02:00:00Z","reference_number":"EMA/356087/2010","document_url":"https://www.ema.europa.eu/en/documents/report/nineteenth-pandemic-pharmacovigilance-update_en.pdf"},
    {"id":"23162","name":"VICH GL54 studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-12-19T13:20:00Z","last_updated_date":"2016-12-19T13:20:00Z","reference_number":"EMA/CVMP/VICH/699251/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl54-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-acute-reference-dose-arfd_en.pdf"},
    {"id":"23163","name":"Presentation - EudraVigilance: Preparing for change (Francois Domergue)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-preparing-change-francois-domergue_en.pdf"},
    {"id":"23166","name":"Presentation - Implementation of the new pharmacovigilance legislation: Overall update and activities in 2013 (Franck Diafouka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-new-pharmacovigilance-legislation-overall-update-and-activities-2013-franck-diafouka_en.pdf"},
    {"id":"23171","name":"Mandate, objectives and rules of procedure for the temporary working parties and drafting groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-08-04T02:00:00Z","last_updated_date":"2010-08-04T02:00:00Z","reference_number":"EMA/CHMP/319651/2010","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-temporary-working-parties-and-drafting-groups_en.pdf"},
    {"id":"23172","name":"CPMP concludes its assessment of ‘third generation’ combined oral contraceptives and the risk of venous thromboembolism","type":"position","status":"unknown","consultation_date":"","first_published_date":"2001-09-28T02:00:00Z","last_updated_date":"2001-09-28T02:00:00Z","reference_number":"EMEA/CPMP/2250/01/en/Final","document_url":"https://www.ema.europa.eu/en/documents/position/cpmp-concludes-its-assessment-third-generation-combined-oral-contraceptives-and-risk-venous-thromboembolism_en.pdf"},
    {"id":"23175","name":"Human medicines highlights - September 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-10-15T16:26:00Z","last_updated_date":"2015-10-15T16:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-september-2015_en.pdf"},
    {"id":"23177","name":"Questions and answers on the recommendation to withdraw the marketing authorisation of Veralipride","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-07-23T02:08:21Z","last_updated_date":"2007-07-23T02:08:21Z","reference_number":"EMEA/299468/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-recommendation-withdraw-marketing-authorisation-veralipride_en.pdf"},
    {"id":"23178","name":"Review of oral methadone medicines containing povidone started","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"EMA/211946/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-oral-methadone-medicines-containing-povidone-started_en.pdf"},
    {"id":"23184","name":"Overview of comments received on draft guideline on procedures for re-examination of CHMP opinions","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-06-26T02:00:00Z","last_updated_date":"2006-06-26T02:00:00Z","reference_number":"EMEA/CHMP/149558/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-guideline-procedures-re-examination-chmp-opinions_en.pdf"},
    {"id":"23185","name":"ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 5 - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-12-18T13:30:00Z","last_updated_date":"2017-12-18T13:30:00Z","reference_number":"EMA/CHMP/ICH/453276/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e17-general-principles-planning-and-design-multi-regional-clinical-trials-step-5-first-version_en.pdf"},
    {"id":"23186","name":"Concept paper on extrapolation of efficacy and safety in medicine development","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T15:48:00Z","last_updated_date":"2013-04-23T15:48:00Z","reference_number":"EMA/129698/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-extrapolation-efficacy-and-safety-medicine-development_en.pdf"},
    {"id":"23187","name":"Presentation - Studies in neonatal fungal infections (Irja Lutsar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2015-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-studies-neonatal-fungal-infections-irja-lutsar_en.pdf"},
    {"id":"23188","name":"Public statement on Olanzapine Cipla: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-07-24T18:00:00Z","last_updated_date":"2014-07-24T18:00:00Z","reference_number":"EMEA/H/C/000793","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-olanzapine-cipla-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"23189","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Thymus vulgaris L. and Thymus zygis L, herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T00:09:21Z","last_updated_date":"2014-06-03T01:09:21Z","reference_number":"EMEA/HMPC/453713/2007EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba_en.pdf"},
    {"id":"23193","name":"Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T17:20:00Z","last_updated_date":"2016-10-19T17:24:31Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluocinolone-acetonide-intravitreal-implant-applicator-list-nationally-authorised-medicinal-products-psusa00010224201602_en.pdf"},
    {"id":"23195","name":"Testosterone Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T14:00:00Z","last_updated_date":"2014-07-11T19:00:00Z","reference_number":"EMA/PRAC/178709/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/testosterone-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"23196","name":"Meeting highlights from the Paediatric Committee: 4 - 6 February 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-02-13T01:00:00Z","last_updated_date":"2009-02-13T01:00:00Z","reference_number":"http://www.emea.europa.eu/pdfs/human/press/pr/8519","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-4-6-february-2009_en.pdf"},
    {"id":"23197","name":"CHMP summary of positive opinion for Febuxostat Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/221561/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-febuxostat-mylan_en.pdf"},
    {"id":"23199","name":"Presentation - Breakout session - Neonatal brain Injury (Heike Rabe and Ronit Pressler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-neonatal-brain-injury-heike-rabe-and-ronit-pressler_en.pdf"},
    {"id":"23200","name":"Ergot derivatives Article-31 referral - Restrictions on use of medicines containing ergot derivatives","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-10-25T02:00:00Z","reference_number":"EMA/385266/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_en.pdf"},
    {"id":"23203","name":"Committee for Proprietary Medicinal Products (CPMP) 60th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-05-29T02:00:00Z","last_updated_date":"2000-05-29T02:00:00Z","reference_number":"CPMP/1304/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-60th-plenary-meeting_en.pdf"},
    {"id":"23205","name":"Presentation - Extrapolation & Pediatric Development: A case study from pediatric Ulcerative Colitis (Richard Strauss)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-pediatric-development-case-study-pediatric-ulcerative-colitis-richard-strauss_en.pdf"},
    {"id":"23206","name":"Presentation - Mutual-recognition-procedure and decentralised-procedure step-by-step instructions: How to apply and how the procedures are conducted (Peter Bachmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mutual-recognition-procedure-and-decentralised-procedure-step-step-instructions-how-apply-and-how-procedures-are-conducted-peter-bachmann_en.pdf"},
    {"id":"23207","name":"Type II variations (90-day procedure)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-25T01:09:21Z","last_updated_date":"2009-12-03T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/type-ii-variations-90-day-procedure_en.pdf"},
    {"id":"23208","name":"Overview of comments received on Community herbal monograph on Urtica dioica L.; Urtica urens L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-01-17T01:00:00Z","last_updated_date":"2011-01-17T01:00:00Z","reference_number":"EMA/HMPC/584060/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-urtica-dioica-l-urtica-urens-l-folium_en.pdf"},
    {"id":"23209","name":"Germanium (68Ge) chloride / gallium (68Ga) chloride: List of nationally authorised medicinal products - PSUSA/00010364/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T11:30:00Z","last_updated_date":"2017-11-15T11:30:00Z","reference_number":"EMA/727988/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/germanium-68ge-chloride-gallium-68ga-chloride-list-nationally-authorised-medicinal-products-psusa00010364201703_en.pdf"},
    {"id":"23210","name":"Guidance on format of the risk-management plan in the European Union part II: Module SVII - Identified and potential risks","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2012-11-14T01:00:00Z","reference_number":"EMA/714754/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-svii-identified-and-potential-risks_en.doc"},
    {"id":"23212","name":"Procedure for review of information on medicinal products by patients' and consumers' organisations","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-11-24T01:00:00Z","last_updated_date":"2010-05-11T02:00:00Z","reference_number":"EMA/174255/2010 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-review-information-medicinal-products-patients-and-consumers-organisations_en.pdf"},
    {"id":"23214","name":"Work Instructions for QRD co-ordination of post-opinion linguistic reviews of Initial Applications and Annex II applications","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2010-02-18T01:00:00Z","last_updated_date":"2010-02-18T01:00:00Z","reference_number":"WIN/EMA/0106","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-qrd-co-ordination-post-opinion-linguistic-reviews-initial-applications-and-annex-ii-applications_en.pdf"},
    {"id":"23217","name":"Azelastine / fluticasone: List of nationally authorised medicinal products - PSUSA/00010067/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-10-18T14:01:11Z","reference_number":"EMA/447143/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/azelastine-fluticasone-list-nationally-authorised-medicinal-products-psusa00010067201510_en.pdf"},
    {"id":"23220","name":"Methadone Article-107i procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-notification_en.pdf"},
    {"id":"23221","name":"EU/3/16/1812: Public summary of opinion on orphan designation: Antroquinonol for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/15467/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161812-public-summary-opinion-orphan-designation-antroquinonol-treatment-pancreatic-cancer_en.pdf"},
    {"id":"23222","name":"Agenda – Expert meeting on paediatric asthma","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T17:01:00Z","last_updated_date":"2012-11-23T17:01:00Z","reference_number":"EMA/620746/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-expert-meeting-paediatric-asthma_en.pdf"},
    {"id":"23224","name":"Focus group meeting on user safety guideline report of the meeting held on 13 december 2007","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-03-17T01:00:00Z","last_updated_date":"2008-03-17T01:00:00Z","reference_number":"EMEA/CVMP/27466/2008","document_url":"https://www.ema.europa.eu/en/documents/report/focus-group-meeting-user-safety-guideline-report-meeting-held-13-december-2007_en.pdf"},
    {"id":"23226","name":"COMP meeting report on the review of applications for orphan designation: March 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T13:30:00Z","last_updated_date":"2015-03-30T13:30:00Z","reference_number":"EMA/COMP/138154/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-march-2015_en.pdf"},
    {"id":"23227","name":"Final list of references supporting the assessment of Prunus africana (Hook f.) Kalkm., cortex","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2017-09-01T02:00:00Z","last_updated_date":"2017-09-01T02:00:00Z","reference_number":"EMA/HMPC/680625/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-prunus-africana-hook-f-kalkm-cortex_en.pdf"},
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    {"id":"23310","name":"Withdrawal assessment report for Gallimune Flu H5N9(i)","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-11-16T01:00:00Z","last_updated_date":"2010-11-16T01:00:00Z","reference_number":"EMA/675117/2010","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-gallimune-flu-h5n9i_en.pdf"},
    {"id":"23311","name":"Agenda - Patient registries workshop","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-08-01T14:00:00Z","last_updated_date":"2016-10-20T14:00:00Z","reference_number":"EMA/439861/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patient-registries-workshop_en.pdf"},
    {"id":"23312","name":"Call for submission of scientific data relating to the assessment of Gentianae radix - First version","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2008-03-19T00:09:21Z","last_updated_date":"2008-03-19T00:09:21Z","reference_number":"EMEA/HMPC/145174/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-gentianae-radix-first-version_en.pdf"},
    {"id":"23313","name":"Scientific recommendation on classification of advanced therapy medicinal products: expanded autologous auricular chondrocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T16:40:00Z","last_updated_date":"2018-06-27T16:40:00Z","reference_number":"EMA/177325/2018 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-expanded-autologous-auricular-chondrocytes_en.pdf"},
    {"id":"23315","name":"EU/3/11/862: Public summary of opinion on orphan designation: Apomorphine hydrochloride for the treatment of moderate and severe traumatic brain injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/COMP/158697/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311862-public-summary-opinion-orphan-designation-apomorphine-hydrochloride-treatment-moderate-and-severe-traumatic-brain-injury_en.pdf"},
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    {"id":"23317","name":"Presentation - Do information tools need adapting for an effective communication in healthcare? (Sara Rubinelli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-do-information-tools-need-adapting-effective-communication-healthcare-sara-rubinelli_en.pdf"},
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    {"id":"23320","name":"PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T14:00:00Z","last_updated_date":"2013-10-11T14:00:00Z","reference_number":"EMA/606303/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-confirms-hydroxyethyl-starch-solutions-hes-should-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_en.pdf"},
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    {"id":"23324","name":"Summary of the evaluation of the proposed product-specific waiver: Amlodipine / perindopril (erbumine) for treatment of hypertension and for treatment of stable coronary artery disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/712433/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-product-specific-waiver-amlodipine-perindopril-erbumine-treatment-hypertension-and-treatment-stable-coronary-artery-disease_en.pdf"},
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    {"id":"23411","name":"EU/3/05/306: Public summary of positive opinion for imatinib mesilate for the treatment of mastocytosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T01:00:00Z","last_updated_date":"2015-02-10T01:00:00Z","reference_number":"EMEA/COMP/244165/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305306-public-summary-positive-opinion-imatinib-mesilate-treatment-mastocytosis_en.pdf"},
    {"id":"23414","name":"Human medicines highlights - June 2014","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T17:55:00Z","last_updated_date":"2014-07-08T17:55:00Z","reference_number":"Issue 64","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-june-2014_en.pdf"},
    {"id":"23418","name":"CHMP summary of positive opinion for Oslif Breezhaler","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/592262/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-oslif-breezhaler_en.pdf"},
    {"id":"23421","name":"Report on first workshop on a European Paediatric Research network, 16 February 2009","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-03-03T00:09:21Z","last_updated_date":"2009-03-03T00:09:21Z","reference_number":"EMEA/105690/2009","document_url":"https://www.ema.europa.eu/en/documents/report/report-first-workshop-european-paediatric-research-network-16-february-2009_en.pdf"},
    {"id":"23422","name":"Durogesic Article-30 referral - Questions and answers on Durogesic and associated names (fentanyl transdermal patches)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-10-19T14:00:00Z","reference_number":"EMA/491912/2016 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/durogesic-article-30-referral-questions-and-answers-durogesic-and-associated-names-fentanyl-transdermal-patches_sv.pdf"}},
    {"id":"23423","name":"CHMP post-authorisation summary of positive opinion for ViraferonPeg","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2021-01-22T01:00:00Z","reference_number":"EMA/CHMP/114049/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-viraferonpeg_en.pdf"},
    {"id":"23425","name":"Overview of the training on electronic submission of information on medicines - new pharmacovigilance legislation (Art. 57, paragraph 2,\n\n2nd sub-paragraph, Regulation (EC) No. 726/2004): 20-21 March, Madrid, Spain","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/overview-training-electronic-submission-information-medicines-new-pharmacovigilance-legislation-art-57-paragraph-2-2nd-sub-paragraph-regulation-ec-no-7262004-20-21-march-madrid-spain_en.pdf"},
    {"id":"23426","name":"Summary of the EMA public hearing on valproate in pregnancy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-04T19:20:00Z","last_updated_date":"2017-10-04T19:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/summary-ema-public-hearing-valproate-pregnancy_en.pdf"},
    {"id":"23428","name":"Questions and answers on the withdrawal of the marketing authorisation application for Corluxin (mifepristone)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/261739/2015","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-corluxin-mifepristone_sv.pdf"}},
    {"id":"23431","name":"Public statement on Sifrol, Daquiran, Mirapexin (pramipexole) - Recommendation to reinforce the warning of sudden onset of sleep","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-08-03T02:00:00Z","last_updated_date":"1999-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-sifrol-daquiran-mirapexin-pramipexole-recommendation-reinforce-warning-sudden-onset-sleep_en.pdf"},
    {"id":"23433","name":"Background to the CPMP position paper on possible pre-clinical studies to investigate addiction and dependence/withdrawal related to the use of selective serotonin uptake inhibitors (SSRIs)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-12-14T01:00:00Z","last_updated_date":"2000-12-14T01:00:00Z","reference_number":"CPMP/2278/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/background-cpmp-position-paper-possible-pre-clinical-studies-investigate-addiction-and-dependencewithdrawal-related-use-selective-serotonin-uptake-inhibitors-ssris_en.pdf"},
    {"id":"23434","name":"EU/3/15/1517: Public summary of opinion on orphan designation: 2-((3-((4-((3-aminopropyl)amino)butyl)amino)propyl)amino)-N-((5S,5aS,8aR,9R)-9-(4-hydroxy-3,5-dimethoxyphenyl)-8-oxo-5,5a,6,8,8a,9-hexahydrofuro[3',4':6,7]na...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/432053/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151517-public-summary-opinion-orphan-designation-2-3-4-3-aminopropylaminobutylaminopropylamino-n-5s5as8ar9r-9-4-hydroxy-35-dimethoxyphenyl-8-oxo-55a688a9-hexahydrofuro3467na_en.pdf"},
    {"id":"23436","name":"Agenda - Workshop on the 'Guideline on pharmaceutical development of medicines for paediatric use'","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-11-19T01:00:00Z","last_updated_date":"2014-11-19T01:00:00Z","reference_number":"EMA/545429/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf"},
    {"id":"23439","name":"Overview of comments received on draft guideline on quality of herbal medicinal products/traditional herbal medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-06-09T02:00:00Z","last_updated_date":"2006-06-09T02:00:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/40683/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-quality-herbal-medicinal-productstraditional-herbal-medicinal-products_en.pdf"},
    {"id":"23440","name":"EU/3/15/1543: Public summary of opinion on orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for the treatment of mitochondrial encephalomyopathy, lactic acid...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/508508/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151543-public-summary-opinion-orphan-designation-s-6-hydroxy-2578-tetramethyl-n-r-piperidin-3-ylchroman-2-carboxamide-hydrochloride-treatment-mitochondrial-encephalomyopathy-lactic-acid_en.pdf"},
    {"id":"23441","name":"EU/3/12/1031: Public summary of opinion on orphan designation: Ketoconazole for the treatment of Cushing’s syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-26T16:30:00Z","last_updated_date":"2012-09-26T16:30:00Z","reference_number":"EMA/COMP/528385/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121031-public-summary-opinion-orphan-designation-ketoconazole-treatment-cushings-syndrome_en.pdf"},
    {"id":"23444","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the January 2011 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-01-17T01:00:00Z","last_updated_date":"2011-01-17T01:00:00Z","reference_number":"EMA/781001/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-january-2011-meeting_en.pdf"},
    {"id":"23445","name":"ICH: Q 1 A (R2): Stability testing of new drug substances and products - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-08-01T02:00:00Z","last_updated_date":"2003-08-01T02:00:00Z","reference_number":"CPMP/ICH/2736/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-r2-stability-testing-new-drug-substances-and-products-step-5_en.pdf"},
    {"id":"23447","name":"Merck Sharp & Dohme (Europe), Inc. withdraws its marketing authorisation application for Janacti (sitagliptin and pioglitazone) and related trade names","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-14T01:00:00Z","last_updated_date":"2011-11-14T01:00:00Z","reference_number":"EMA/887576/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/merck-sharp-dohme-europe-inc-withdraws-its-marketing-authorisation-application-janacti-sitagliptin-and-pioglitazone-and-related-trade-names_en.pdf"},
    {"id":"23448","name":"Presentation - Implementation of the pharmacovigilance legislation. The views of physicians (Erzsà©bet Podmaniczky)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-pharmacovigilance-legislation-views-physicians-erzsacbet-podmaniczky_en.pdf"},
    {"id":"23449","name":"Doramectin (Extension to deer including reindeer): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/637/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/doramectin-extension-deer-including-reindeer-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"23452","name":"Opinion of the HMPC on a European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-01-13T16:10:00Z","last_updated_date":"2016-01-13T16:10:00Z","reference_number":"EMA/HMPC/774041/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-epilobium-angustifolium-l-andor-epilobium-parviflorum-schreb-herba_en.pdf"},
    {"id":"23453","name":"CHMP summary of positive opinion for Ioa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2014-08-28T02:00:00Z","reference_number":"EMA/CHMP/195954/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ioa_en.pdf"},
    {"id":"23454","name":"EU/3/13/1127: Public summary of opinion on orphan designation: Inotuzumab ozogamicin for the treatment of B-cell acute lymphoblastic leukaemia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-06-25T19:00:00Z","reference_number":"EMA/COMP/268991/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131127-public-summary-opinion-orphan-designation-inotuzumab-ozogamicin-treatment-b-cell-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"23455","name":"Recommendations in the area of pharmacovigilance - Emmanuel Trenado","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-12-03T01:00:00Z","last_updated_date":"2004-12-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/recommendations-area-pharmacovigilance-emmanuel-trenado_en.pdf"},
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    {"id":"23471","name":"Presentation - 2015 shortages workshop (Brendan Cuddy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2015-shortages-workshop-brendan-cuddy_en.pdf"},
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    {"id":"23493","name":"Standard operating procedure for procedure for liaising between the European Medicines Agency, the Committee for Medicinal Products for Human Use (CHMP) and the Clinical Trials Facilitation Group on the potential CHMP ne...","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T12:16:00Z","last_updated_date":"2012-03-01T12:16:00Z","reference_number":"SOP/INSP/2033","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-procedure-liaising-between-european-medicines-agency-committee-medicinal-products-human-use-chmp-and-clinical-trials-facilitation-group-potential-chmp-ne_en.pdf"},
    {"id":"23494","name":"Tysabri Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-05-08T14:00:00Z","last_updated_date":"2016-01-15T12:59:00Z","reference_number":"EMA/PRAC/293314/2015 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/referral/tysabri-article-20-procedure-timetable-procedure_en.pdf"},
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    {"id":"23496","name":"Hearing the Association of the European Self-Medication Industry during the May 2014 Working Party on Community Monographs and Community List meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T14:00:00Z","last_updated_date":"2014-10-21T14:00:00Z","reference_number":"EMA/HMPC/540095/2014","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-during-may-2014-working-party-community-monographs-and-community-list-meeting_en.pdf"},
    {"id":"23498","name":"Committee for medicinal products for veterinary use -\n\nEMEA public bulletin 2008 on veterinary pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T01:00:00Z","last_updated_date":"2009-02-24T01:00:00Z","reference_number":"EMEA/CVMP/PhVWP/253196/2008","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-emea-public-bulletin-2008-veterinary-pharmacovigilance_en.pdf"},
    {"id":"23501","name":"Update on review of valsartan medicines due to detection of NDMA","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-08-10T02:00:00Z","last_updated_date":"2018-08-10T02:00:00Z","reference_number":"EMA/543774/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines-due-detection-ndma_en.pdf"},
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    {"id":"23507","name":"Presentation - eHealth at EU level: perspectives from the European Commission - EMA's PCWP and HCPWP joint meeting (Katja Neubauer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ehealth-eu-level-perspectives-european-commission-emas-pcwp-and-hcpwp-joint-meeting-katja-neubauer_en.pdf"},
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    {"id":"23524","name":"Overview of comments received on ‘Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-11-18T01:00:00Z","last_updated_date":"2016-11-18T01:00:00Z","reference_number":"EMA/CHMP/852405/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-paediatric-addendum-chmp-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure_en.pdf"},
    {"id":"23525","name":"Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-17T16:34:00Z","last_updated_date":"2018-07-17T16:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-notification_en.pdf"},
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    {"id":"23528","name":"Guideline on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module V on risk management system and subsequent revision 3 of the definitions annex and revision 1 of module XVI o...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T11:30:00Z","last_updated_date":"2014-04-25T11:30:00Z","reference_number":"EMA/213031/2014","document_url":"https://www.ema.europa.eu/en/documents/other/guideline-good-pharmacovigilance-practices-introductory-cover-note-last-updated-revision-1-module-v-risk-management-system-and-subsequent-revision-3-definitions-annex-and-revision-1-module-xvi-o_en.pdf"},
    {"id":"23530","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Kanuma (sebelipase alfa) for the treatment of lysosomal acid lipase deficiency","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-09-08T02:00:00Z","last_updated_date":"2015-09-08T02:00:00Z","reference_number":"EMA/COMP/470354/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-kanuma-sebelipase-alfa-treatment-lysosomal-acid-lipase-deficiency_en.pdf"},
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    {"id":"23536","name":"Article 58 Strategic Review – Summary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-04-26T17:30:00Z","last_updated_date":"2016-04-26T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/article-58-strategic-review-summary_en.pdf"},
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    {"id":"23541","name":"Presentation - Neuromyelitis optica: Is there treatment equipoise? (Bruce Cree)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-neuromyelitis-optica-there-treatment-equipoise-bruce-cree_en.pdf"},
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    {"id":"23555","name":"Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-14T14:00:00Z","last_updated_date":"2018-08-14T14:00:00Z","reference_number":"EMA/553008/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/epinastine-list-nationally-authorised-medicinal-products-psusa00001231201710_en.pdf"},
    {"id":"23557","name":"EU/3/10/83: Public summary of opinion on orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for the treatment of mantle cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2011-11-18T01:00:00Z","reference_number":"EMA/COMP/758068/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu31083-public-summary-opinion-orphan-designation-autologous-tumour-derived-immunoglobulin-idiotype-coupled-keyhole-limpet-hemocyanin-treatment-mantle-cell-lymphoma_en.pdf"},
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    {"id":"23609","name":"PRAC recommends new measures to avoid valproate exposure in pregnancy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T01:00:00Z","last_updated_date":"2018-02-09T01:00:00Z","reference_number":"EMA/67672/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-new-measures-avoid-valproate-exposure-pregnancy_en.pdf"},
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    {"id":"23620","name":"Addendum to assessment report on Commiphora molmol Engler, gummi-resina","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-09-05T17:30:00Z","last_updated_date":"2018-09-05T17:30:00Z","reference_number":"EMA/HMPC/364552/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-commiphora-molmol-engler-gummi-resina_en.pdf"},
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    {"id":"23629","name":"EU/3/09/631: Public summary of positive opinion for orphan designation of talampanel for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-12T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMEA/COMP/160717/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309631-public-summary-positive-opinion-orphan-designation-talampanel-treatment-glioma_en.pdf"},
    {"id":"23631","name":"Presentation - Proposed global pediatric clinical research network - Overview (William R. Treem)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposed-global-pediatric-clinical-research-network-overview-william-r-treem_en.pdf"},
    {"id":"23634","name":"Guideline on the clinical investigation of medicinal products indicated for generalised anxiety disorder","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-01-20T01:00:00Z","last_updated_date":"2005-01-20T01:00:00Z","reference_number":"CPMP/EWP/4284/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-indicated-generalised-anxiety-disorder_en.pdf"},
    {"id":"23635","name":"Hydroxyzine Article-31 referral - PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-02-13T13:00:00Z","last_updated_date":"2015-02-13T13:00:00Z","reference_number":"EMA/85678/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-prac-recommends-new-measures-minimise-known-heart-risks-hydroxyzine-containing-medicines_en.pdf"},
    {"id":"23637","name":"EU/3/16/1784: Public summary of positive opinion for orphan designation of particles comprised of methacrylic acid based co-polymer, cross-linked with a bi-functional cross-linker, purified to bind L-phenylalanine and L-...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2016-12-13T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161784-public-summary-positive-opinion-orphan-designation-particles-comprised-methacrylic-acid-based-co-polymer-cross-linked-bi-functional-cross-linker-purified-bind-l-phenylalanine-and-l_en.pdf"},
    {"id":"23638","name":"ENCePP - 10 years of collaboration to strengthen the monitoring of benefits and risks of medicines in Europe","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-24T01:00:00Z","last_updated_date":"2017-11-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/encepp-10-years-collaboration-strengthen-monitoring-benefits-and-risks-medicines-europe_en.pdf"},
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    {"id":"23643","name":"Presentation - Feasibility of stratification of sales data (Jordi Torren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T17:00:00Z","last_updated_date":"2016-03-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feasibility-stratification-sales-data-jordi-torren_en.pdf"},
    {"id":"23644","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T12:00:00Z","last_updated_date":"2018-04-27T12:00:00Z","reference_number":"EMA/189006/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-march-2018_en.pdf"},
    {"id":"23645","name":"Superseded assessment report on Trigonella foenum-graecum L., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-08-30T02:00:00Z","last_updated_date":"2022-08-30T02:00:00Z","reference_number":"EMA/HMPC/146220/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-trigonella-foenum-graecum-l-semen_en.pdf"},
    {"id":"23647","name":"Corticotrophin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-12-01T01:00:00Z","last_updated_date":"1997-12-01T01:00:00Z","reference_number":"EMEA/MRL/308/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/corticotrophin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"23650","name":"Presentation - Identification of preventable adverse drug reactions from a regulatory perspective (Almath Spooner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-identification-preventable-adverse-drug-reactions-regulatory-perspective-almath-spooner_en.pdf"},
    {"id":"23652","name":"Presentation - IFAH-Europe: The impact on public and animal health of the use of antibiotics in animals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ifah-europe-impact-public-and-animal-health-use-antibiotics-animals_en.pdf"},
    {"id":"23653","name":"Transatlantic simplification of administrative procedures - Arielle North","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/transatlantic-simplification-administrative-procedures-arielle-north_en.pdf"},
    {"id":"23655","name":"World Health organization's (WHO) confirmation letter on the working arrangement to exchange non-public information on medical products between the European Commission's Directorate General for Health and Food Safety (DG...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T12:00:00Z","last_updated_date":"2015-09-22T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/world-health-organizations-who-confirmation-letter-working-arrangement-exchange-non-public-information-medical-products-between-european-commissions-directorate-general-health-and-food-safety-dg_en.pdf"},
    {"id":"23658","name":"Presentation - Pharmacovigilance and risk minimisation plans, Jan Petracek, PharmInvent","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-and-risk-minimisation-plans-jan-petracek-pharminvent_en.pdf"},
    {"id":"23660","name":"Concept paper on the revision of the guidance on similar biological medicinal products containing recombinant Erythropoietins","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/BMWP/170734/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidance-similar-biological-medicinal-products-containing-recombinant-erythropoietins_en.pdf"},
    {"id":"23661","name":"Presentation - Session 3: Clinical trial designs in rheumatoid arthritis (Andreas Kouroumalis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-09T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-clinical-trial-designs-rheumatoid-arthritis-andreas-kouroumalis_en.pdf"},
    {"id":"23664","name":"Presentation: Outline of revised EudraVigilance access policy (medicines for human use)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-11-22T01:00:00Z","last_updated_date":"2010-11-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outline-revised-eudravigilance-access-policy-medicines-human-use_en.pdf"},
    {"id":"23669","name":"Final opinion of the HMPC on a European Union herbal monograph on Aloe barbadensis Mill. and on Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-04-10T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMA/HMPC/28044/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-aloe-barbadensis-mill-and-aloe-various-species-mainly-aloe-ferox-mill-and-its-hybrids-folii-succus-siccatus_en.pdf"},
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    {"id":"23674","name":"Presentation - Non-clinical development of cell-based medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-clinical-development-cell-based-medicinal-products_en.pdf"},
    {"id":"23675","name":"EU/3/18/1998: Public summary of opinion on orphan designation: Patidegib for the treatment of naevoid basal-cell carcinoma syndrome (Gorlin\n\nsyndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-08T02:00:00Z","last_updated_date":"2018-05-08T02:00:00Z","reference_number":"EMA/116423/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181998-public-summary-opinion-orphan-designation-patidegib-treatment-naevoid-basal-cell-carcinoma-syndrome-gorlin-syndrome_en.pdf"},
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    {"id":"23683","name":"Gadopentetic acid: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001504/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T01:00:00Z","last_updated_date":"2016-10-19T12:37:32Z","reference_number":"EMA/172348/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadopentetic-acid-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001504201504_en.pdf"},
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    {"id":"23688","name":"EU enlargement countries to join EMEA as observers from 1 April 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-03-31T02:00:00Z","last_updated_date":"2003-03-31T02:00:00Z","reference_number":"EMEA/D/8004/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-enlargement-countries-join-emea-observers-1-april-2003_en.pdf"},
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    {"id":"23691","name":"EU/3/17/1934: Public summary of opinion on orphan designation: (R)-troloxamide quinone for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/693845/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171934-public-summary-opinion-orphan-designation-r-troloxamide-quinone-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
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    {"id":"23760","name":"Opinion following an Article 33(4) referral for Nuflor-300 mg/ml solution for injection for cattle and sheep","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T02:00:00Z","last_updated_date":"2012-10-19T02:00:00Z","reference_number":"EMA/556747/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-nuflor-300-mgml-solution-injection-cattle-and-sheep_sv.pdf"}},
    {"id":"23761","name":"Committee for Proprietary Medicinal Products (CPMP) 18th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-07-18T02:00:00Z","last_updated_date":"1996-07-18T02:00:00Z","reference_number":"CPMP/644/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-18th-plenary-meeting_en.pdf"},
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    {"id":"23769","name":"Antibiotic Residues in Honey: The situation for the trade and industry, Frank Filodda, European Federation of Honey Packers and Distributors (FEEDM)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/antibiotic-residues-honey-situation-trade-and-industry-frank-filodda-european-federation-honey-packers-and-distributors-feedm_en.pdf"},
    {"id":"23772","name":"Procedural announcements: Committee for Medicinal Products for Human Use meeting 17-20 October 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-24T13:36:00Z","last_updated_date":"2011-10-24T13:36:00Z","reference_number":"EMA/CHMP/832563/2011","document_url":"https://www.ema.europa.eu/en/documents/other/procedural-announcements-committee-medicinal-products-human-use-meeting-17-20-october-2011_en.pdf"},
    {"id":"23777","name":"Annex II: Expression of interest form - Donation of EMA assets no. EMA/2014/28/IS","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-ii-expression-interest-form-donation-ema-assets-no-ema201428is_en.doc"},
    {"id":"23778","name":"Agenda – Paediatric Rheumatology Expert Group Meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"EMA/719882/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-paediatric-rheumatology-expert-group-meeting_en.pdf"},
    {"id":"23779","name":"Work Instructions for Connect to e-Submission trading community","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-06-24T02:00:00Z","last_updated_date":"2009-06-24T02:00:00Z","reference_number":"WIN/IT/5030","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-connect-e-submission-trading-community_en.pdf"},
    {"id":"23780","name":"Amlodipine lisinopril : List of nationally authorised medicinal products - PSUSA/00010192/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T17:33:00Z","last_updated_date":"2017-09-06T17:36:19Z","reference_number":"EMA/529926/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-lisinopril-list-nationally-authorised-medicinal-products-psusa00010192201612_en.pdf"},
    {"id":"23781","name":"Withdrawal assessment report for Aquilda","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-25T02:00:00Z","last_updated_date":"2008-07-25T02:00:00Z","reference_number":"EMEA/CHMP/316130/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-aquilda_en.pdf"},
    {"id":"23783","name":"CVMP post-authorisation summary of positive opinion for Equilis Prequenza","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T17:00:00Z","last_updated_date":"2013-02-08T17:00:00Z","reference_number":"EMA/CVMP/36013/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-equilis-prequenza_en.pdf"},
    {"id":"23784","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-01-19T11:37:00Z","last_updated_date":"2015-01-19T11:37:00Z","reference_number":"EMA/784039/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-december-2014_en.pdf"},
    {"id":"23786","name":"New medicine for multiple sclerosis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2017-11-10T01:00:00Z","reference_number":"EMA/741144/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-multiple-sclerosis_en.pdf"},
    {"id":"23787","name":"Key milestones of EMA interactions with patients and consumers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T01:00:00Z","last_updated_date":"2017-08-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/key-milestones-ema-interactions-patients-and-consumers_en.pdf"},
    {"id":"23789","name":"Withdrawal letter: Draxxin","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-04T02:00:00Z","last_updated_date":"2012-07-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-draxxin_en.pdf"},
    {"id":"23791","name":"Committee for veterinary medicinal products: 56th meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-06-22T14:09:21Z","last_updated_date":"2000-06-22T14:09:21Z","reference_number":"EMEA/CVMP/461/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-56th-meeting_en.pdf"},
    {"id":"23792","name":"Presentation - SPOR data services: questions and answers webinar with industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-06T01:00:00Z","last_updated_date":"2018-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spor-data-services-questions-and-answers-webinar-industry_en.pdf"},
    {"id":"23794","name":"EMA Management Board: highlights of October 2015 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/653178/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-october-2015-meeting_en.pdf"},
    {"id":"23798","name":"CHMP post-authorisation summary of positive opinion for Celsentri (X-46-G)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-04-21T17:00:00Z","last_updated_date":"2017-04-21T17:00:00Z","reference_number":"EMA/CHMP/219462/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-celsentri-x-46-g_en.pdf"},
    {"id":"23799","name":"ICH guideline M8 on eCTD – questions and answers - Step 5","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T13:00:00Z","last_updated_date":"2015-08-04T13:00:00Z","reference_number":"EMA/CHMP/ICH/820/2003","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m8-ectd-questions-and-answers-step-5_en.pdf"},
    {"id":"23801","name":"European Medicines Agency finalises set of guidelines on similar biological medicines and publishes two more new concept papers","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-08T01:00:00Z","last_updated_date":"2006-03-08T01:00:00Z","reference_number":"EMEA/84561/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-finalises-set-guidelines-similar-biological-medicines-and-publishes-two-more-new-concept-papers_en.pdf"},
    {"id":"23802","name":"EU/3/15/1446: Public summary of opinion on orphan designation: N-(3-(4-(3-(diisobutylamino)propyl)piperazin-1-yl)propyl)-1H-benzo[d]imidazol-2-amine disulphate salt for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2015-04-09T02:00:00Z","reference_number":"EMA/COMP/43938/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151446-public-summary-opinion-orphan-designation-n-3-4-3-diisobutylaminopropylpiperazin-1-ylpropyl-1h-benzodimidazol-2-amine-disulphate-salt-treatment-progressive-supranuclear-palsy_en.pdf"},
    {"id":"23803","name":"Overview of comments received on 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues' (EMEA/CHMP/BMWP/42832/2005 Rev. 1)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-03-19T11:37:00Z","last_updated_date":"2018-03-19T11:37:00Z","reference_number":"EMA/CHMP/772616/2013","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-emeachmpbmwp428322005-rev-1_en.pdf"},
    {"id":"23805","name":"Final list of references supporting the assessment of Serenoa repens (W. Bartram) Small, fructus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-03-30T02:00:00Z","last_updated_date":"2016-03-30T02:00:00Z","reference_number":"EMA/HMPC/280080/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"23806","name":"Meeting of the EMEA working party on herbal medicinal products 31 May - 1 June 1999","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-06-03T02:00:00Z","last_updated_date":"1999-06-03T02:00:00Z","reference_number":"EMEA/HMPWP/28/99","document_url":"https://www.ema.europa.eu/en/documents/public-statement/meeting-emea-working-party-herbal-medicinal-products-31-may-1-june-1999_en.pdf"},
    {"id":"23808","name":"CHMP post-authorisation summary of positive opinion for Clopidogrel Winthrop","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2010-11-19T01:00:00Z","reference_number":"EMA/CHMP/740478/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-clopidogrel-winthrop_en.pdf"},
    {"id":"23809","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured human retinal pigment epithelial cells genetically modified to express human factor IX protein","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/799372/2017 Corr.","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-human-retinal-pigment-epithelial-cells-genetically-modified-express-human-factor-ix-protein_en.pdf"},
    {"id":"23810","name":"CHMP summary of opinion for Galafold","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/220589/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-galafold_en.pdf"},
    {"id":"23811","name":"Committee for Proprietary Medicinal Products (CPMP) 34th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-01-30T00:00:00Z","last_updated_date":"1998-01-30T00:00:00Z","reference_number":"CPMP/069/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-34th-plenary-meeting_en.pdf"},
    {"id":"23814","name":"Committee for medicinal products for veterinary use summary of opinion: Leucogen","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-03-13T00:09:21Z","last_updated_date":"2009-03-13T00:09:21Z","reference_number":"EMEA/CVMP/112551/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-leucogen_en.pdf"},
    {"id":"23816","name":"Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with draft revision 2 of module VI on management and reporting of adverse reactions and draft revision 1 of module IX on signal...","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-08-08T17:00:00Z","last_updated_date":"2016-08-08T17:00:00Z","reference_number":"EMA/510998/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-draft-revision-2-module-vi-management-and-reporting-adverse-reactions-and-draft-revision-1-module-ix-signal_en.pdf"},
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    {"id":"23823","name":"Table C: Albumin and other human tissue derived materials","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-06-19T02:09:21Z","last_updated_date":"2009-06-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/table-c-albumin-and-other-human-tissue-derived-materials_en.doc"},
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    {"id":"23882","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (France)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-france_en.pdf"},
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    {"id":"23885","name":"Committee for medicinal products for human use, summary of positive opinion for Topotecan Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/383983/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-topotecan-teva_en.pdf"},
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    {"id":"23888","name":"CHMP summary of positive opinion for Lusduna","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2019-01-22T13:00:00Z","reference_number":"EMA/CHMP/706807/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lusduna_en.pdf"},
    {"id":"23889","name":"Draft list of references supporting the assessment of Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et Arn., Grindelia camporum Greene, herba","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2012-05-16T02:00:00Z","last_updated_date":"2012-05-16T02:00:00Z","reference_number":"EMA/HMPC/748221/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-grindelia-robusta-nutt-grindelia-squarrosa-pursh-dunal-grindelia-humilis-hook-et-arn-grindelia-camporum-greene-herba_en.pdf"},
    {"id":"23891","name":"EU/3/13/1136: Public summary of opinion on orphan designation: 5-[1-(2,6-dichlorobenzyl)piperidin-4-ylmethoxy]quinazoline-2,4-diamine dihydrochloride for the treatment of 5q spinal muscular atrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-10-07T18:00:00Z","reference_number":"EMA/COMP/276580/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131136-public-summary-opinion-orphan-designation-5-1-26-dichlorobenzylpiperidin-4-ylmethoxyquinazoline-24-diamine-dihydrochloride-treatment-5q-spinal-muscular-atrophy_en.pdf"},
    {"id":"23894","name":"PRIME eligibility request: applicant’s justification template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2022-04-06T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/prime-eligibility-request-applicants-justification-template_en.doc"},
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    {"id":"23906","name":"2016 annual report on EudraVigilance for the European Parliament, the Council and the Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-03-17T17:00:00Z","last_updated_date":"2017-03-17T17:00:00Z","reference_number":"EMA/9942/2017","document_url":"https://www.ema.europa.eu/en/documents/report/2016-annual-report-eudravigilance-european-parliament-council-and-commission_en.pdf"},
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    {"id":"23931","name":"CHMP post-authorisation summary of positive opinion for Zinforo","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/CHMP/265582/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zinforo_en.pdf"},
    {"id":"23932","name":"Technical specifications - Annex I - Costing sheet - Procurement procedure EMA/2014/35/RE","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T15:00:00Z","last_updated_date":"2015-02-23T15:00:00Z","reference_number":"EMA/430052/2014","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-i-costing-sheet-procurement-procedure-ema201435re_en.xls"},
    {"id":"23934","name":"Presentation - Product and Substance project overview","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-02T02:00:00Z","last_updated_date":"2017-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-and-substance-project-overview_en.pdf"},
    {"id":"23935","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hypericum perforatum L., herba (well-established medicinal use)","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2009-12-21T00:09:00Z","last_updated_date":"2023-02-22T00:09:00Z","reference_number":"EMA/HMPC/678923/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-hypericum-perforatum-l-herba-well-established-medicinal-use_en.pdf"},
    {"id":"23937","name":"Presentation - The proposed ‘two-step approach’ for MS treatments with a significant effect on immunity (Hideki Garren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposed-two-step-approach-ms-treatments-significant-effect-immunity-hideki-garren_en.pdf"},
    {"id":"23938","name":"EU/3/04/200: (2-aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-bezyloxy benzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclop...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-09-03T02:00:00Z","last_updated_date":"2017-08-16T12:00:00Z","reference_number":"EMA/COMP/44039/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304200-2-aminoethyl-carbamic-acid-2r5s8s11s14r17s19as-11-4-aminobutyl-5-benzyl-8-4-bezyloxy-benzyl-14-1h-indol-3-ylmethyl-4710131619-hexaoxo-17-phenyloctadecahydro-3a69121518-hexaazacyclop_en.pdf"},
    {"id":"23939","name":"Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the cons...","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-08-02T12:00:00Z","last_updated_date":"2017-08-02T12:00:00Z","reference_number":"EMA/213497/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-revision-2-module-vi-icsrs-finalised-post-public-consultation-its-new-addendum-duplicate-management-and-cons_en.pdf"},
    {"id":"23942","name":"Opinion of the CVMP on the establishment of maximum residue limits: Triclabendazole","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-04-13T15:35:00Z","last_updated_date":"2012-04-13T15:35:00Z","reference_number":"EMA/CVMP/848821/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-triclabendazole_en.pdf-0"},
    {"id":"23945","name":"Presentation - 5.3 Leveraging multiple endpoints in small clinical trials (Robin Ristl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-53-leveraging-multiple-endpoints-small-clinical-trials-robin-ristl_en.pdf"},
    {"id":"23947","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T18:45:00Z","last_updated_date":"2015-07-07T18:45:00Z","reference_number":"EMA/391547/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-june-2015_en.pdf"},
    {"id":"23950","name":"Albendazole sulphoxide: Summary Report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-06-01T02:00:00Z","last_updated_date":"1996-06-01T02:00:00Z","reference_number":"EMEA/MRL/094/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/albendazole-sulphoxide-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"23951","name":"CHMP ORGAM agenda for the meeting on 10 July 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-08-01T18:00:00Z","last_updated_date":"2017-08-01T18:00:00Z","reference_number":"EMA/CHMP/439826/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-10-july-2017_en.pdf"},
    {"id":"23952","name":"Superseded assessment report on Melissa officinalis L., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2013-08-05T02:00:00Z","reference_number":"EMEA/HMPC/5342/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-melissa-officinalis-l-folium_en.pdf"},
    {"id":"23953","name":"Agenda - European Medicines Agency-Industry Stakeholders Platform second meeting on paediatric medicines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T16:45:00Z","last_updated_date":"2016-05-27T17:35:00Z","reference_number":"EMA/43044/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-industry-stakeholders-platform-second-meeting-paediatric-medicines_en.pdf"},
    {"id":"23954","name":"Relevant sources for orphan disease prevalence data","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-24T19:00:48Z","last_updated_date":"2014-12-18T11:20:00Z","reference_number":"EMA/452415/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/relevant-sources-orphan-disease-prevalence-data_en.pdf"},
    {"id":"23955","name":"EU/3/15/1449: Public summary of opinion on orphan designation: Myriocin for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2015-04-09T02:00:00Z","reference_number":"EMA/COMP/43665/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151449-public-summary-opinion-orphan-designation-myriocin-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"23956","name":"Tiliae flos: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T00:09:21Z","last_updated_date":"1997-11-01T00:09:21Z","reference_number":"EMEA/MRL/285/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tiliae-flos-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"23957","name":"Idebenone (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00001721/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-18T13:00:00Z","last_updated_date":"2018-05-18T13:00:00Z","reference_number":"EMA/301570/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/idebenone-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00001721201709_en.pdf"},
    {"id":"23958","name":"Draft community herbal monograph on Orthosiphon stamineus Benth., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:09:21Z","last_updated_date":"2009-07-16T02:09:21Z","reference_number":"EMEA/HMPC/281496/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-orthosiphon-stamineus-benth-folium_en.pdf"},
    {"id":"23959","name":"Germanium (68Ge) chloride / gallium (68Ga) chloride: List of nationally authorised medicinal products - PSUSA/00010364/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T02:00:00Z","last_updated_date":"2016-10-18T16:56:41Z","reference_number":"EMA/270823/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/germanium-68ge-chloride-gallium-68ga-chloride-list-nationally-authorised-medicinal-products-psusa00010364201509_en.pdf"},
    {"id":"23961","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP),  14-17 March 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2011-03-18T01:00:00Z","reference_number":"EMA/CHMP/819291/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-march-2011_en.pdf"},
    {"id":"23962","name":"Presentation - Satisfaction survey on involvement of patients, consumers and healthcare professionals during 2016 (N. Bere, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-satisfaction-survey-involvement-patients-consumers-and-healthcare-professionals-during-2016-n-bere-ema_en.pdf"},
    {"id":"23963","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 13-15 July 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-16T02:00:00Z","last_updated_date":"2010-08-03T02:00:00Z","reference_number":"EMA/CVMP/416930/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-july-2010_en.pdf"},
    {"id":"23964","name":"Twenty-ninth meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-02-23T00:09:21Z","last_updated_date":"2001-02-23T00:09:21Z","reference_number":"EMEA/MB/011/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/twenty-ninth-meeting-management-board_en.pdf"},
    {"id":"23965","name":"Presentation - EMA workshop on framework of collaboration with academia (Hans H. Linden)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T02:00:00Z","last_updated_date":"2016-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-workshop-framework-collaboration-academia-hans-h-linden_en.pdf"},
    {"id":"23970","name":"VICH GL6: Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-06-30T02:00:00Z","last_updated_date":"2000-06-30T02:00:00Z","reference_number":"CVMP/VICH/592/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl6-environmental-impact-assessment-eias-veterinary-medicinal-products-phase-i-step-7_en.pdf"},
    {"id":"23971","name":"EU/3/15/1560: Public summary of opinion on orphan designation: N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-18T11:00:00Z","last_updated_date":"2021-09-02T11:00:00Z","reference_number":"EMA/COMP/603544/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151560-public-summary-opinion-orphan-designation-n-2-4z7z10z13z16z19z-docosa-4710131619-hexaenamidoethyl-2-hydroxybenzamide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"23972","name":"Declaration of interests: Ana Hidalgo-Simon","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:00Z","last_updated_date":"2022-06-13T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-ana-hidalgo-simon_en.pdf"},
    {"id":"23973","name":"Presentation for Drug Regimens Consortium (CPTR) scientific-advice meeting with the European Medicines Agency: Hollow-fiber system for tuberculosis (HFS-TB)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-18T15:00:00Z","last_updated_date":"2014-11-18T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-drug-regimens-consortium-cptr-scientific-advice-meeting-european-medicines-agency-hollow-fiber-system-tuberculosis-hfs-tb_en.pdf"},
    {"id":"23976","name":"Public statement on Procomvax: Non-renewal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/337787/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-procomvax-non-renewal-marketing-authorisation-european-union_en.pdf"},
    {"id":"23977","name":"Presentation - Immunogenicity of therapeutic antibodies (Gertjan Wolbink)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunogenicity-therapeutic-antibodies-gertjan-wolbink_en.pdf"},
    {"id":"23978","name":"EU/3/14/1390: Public summary of positive opinion for orphan designation: Bevacizumab for the treatment of hereditary haemorrhagic telangiectasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/736554/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141390-public-summary-positive-opinion-orphan-designation-bevacizumab-treatment-hereditary-haemorrhagic-telangiectasia_en.pdf"},
    {"id":"23979","name":"Presentation - Committee for Orphan Medicinal Products (COMP) feedback - EMA's PCWP and HCPWP joint meeting (Lesley Greene, Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-committee-orphan-medicinal-products-comp-feedback-emas-pcwp-and-hcpwp-joint-meeting-lesley-greene-daniel-oconnor_en.pdf"},
    {"id":"23980","name":"CHMP summary of positive opinion for Grepid","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/CHMP/310253/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-grepid_en.pdf"},
    {"id":"23981","name":"Draft guideline on excipients in the dossier for application for marketing authorisation of a medicinal product - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-11-06T01:00:00Z","last_updated_date":"2006-11-06T01:00:00Z","reference_number":"EMEA/CHMP/QWP/396951/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-excipients-dossier-application-marketing-authorisation-medicinal-product-revision-2_en.pdf"},
    {"id":"23983","name":"CHMP summary of positive opinion for Selincro","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-17T15:05:00Z","reference_number":"EMEA/CHMP/805882/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-selincro_en.pdf"},
    {"id":"23985","name":"Using a primary care database to evaluate drug safety in pregnancy: possibilities & limitations - Corinne de Vries","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/using-primary-care-database-evaluate-drug-safety-pregnancy-possibilities-limitations-corinne-de-vries_en.pdf"},
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    {"id":"24062","name":"Questions and answers on the revocation of the marketing authorisations for medicines containing Bufexamac - Outcome of a procedure under Article 107 of Directive 2001/83/EC","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2011-11-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-revocation-marketing-authorisations-medicines-containing-bufexamac-outcome-procedure-under-article-107-directive-200183ec_sv.pdf"}},
    {"id":"24063","name":"EU/3/05/283: Public summary of positive opinion for orphan designation of recombinant megakaryopoiesis-stimulating protein for the treatment of idiopathic thrombocytopenic purpura","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-06-29T02:00:00Z","last_updated_date":"2019-02-20T12:00:00Z","reference_number":"EMEA/COMP/122763/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305283-public-summary-positive-opinion-orphan-designation-recombinant-megakaryopoiesis-stimulating-protein-treatment-idiopathic-thrombocytopenic-purpura_en.pdf"},
    {"id":"24066","name":"Presentation - Experience from scientific advices for CARs/TCRs (Olli Tenhunen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-scientific-advices-carstcrs-olli-tenhunen_en.pdf"},
    {"id":"24069","name":"Committee for Medicinal Products for Human Use (CHMP) - April 2008 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-05-06T02:00:00Z","last_updated_date":"2008-05-06T02:00:00Z","reference_number":"EMEA/CHMP/213268/2008 - corr","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-april-2008-plenary-meeting-monthly-report_en.pdf"},
    {"id":"24070","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 November 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-11T17:30:00Z","last_updated_date":"2011-11-11T17:30:00Z","reference_number":"EMA/CVMP/871652/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-november-2011_en.pdf"},
    {"id":"24071","name":"Presentation - (One) Statistician(’)s perspectives on extrapolation (Rob Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-one-statisticians-perspectives-extrapolation-rob-hemmings_en.pdf"},
    {"id":"24072","name":"Zinbryta Article-20 procedure - Scientific conclusions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-14T14:46:00Z","last_updated_date":"2018-03-14T14:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinbryta-article-20-procedure-scientific-conclusions_sv.pdf"}},
    {"id":"24074","name":"European Medicines Agency concludes new advice to doctors and patients for Champix needed","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T01:00:00Z","last_updated_date":"2007-12-14T01:00:00Z","reference_number":"EMEA/595516/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-new-advice-doctors-and-patients-champix-needed_en.pdf"},
    {"id":"24076","name":"Final assessment report on Ribes nigrum L., folium - revision 1","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T10:20:00Z","last_updated_date":"2017-12-19T10:20:00Z","reference_number":"EMA/HMPC/745347/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-ribes-nigrum-l-folium-revision-1_en.pdf"},
    {"id":"24078","name":"Presentation - Sarm I/Tadalafil pgase II combination study for erectile dysfunction: modeling and simulation to optimize study design (Charles Benson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sarm-itadalafil-pgase-ii-combination-study-erectile-dysfunction-modeling-and-simulation-optimize-study-design-charles-benson_en.pdf"},
    {"id":"24079","name":"Presentation - Quality defects, falsified products and rapid alerts","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-defects-falsified-products-and-rapid-alerts_en.pdf"},
    {"id":"24080","name":"VICH GL15: Efficacy of anthelmintics - Specific recommendations for equines - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-07-30T02:00:00Z","last_updated_date":"2001-07-30T02:00:00Z","reference_number":"CVMP/VICH/833/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl15-efficacy-anthelmintics-specific-recommendations-equines-step-7_en.pdf"},
    {"id":"24083","name":"Presentation - Beta-lactamase inhibitors (Shampa Das)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-beta-lactamase-inhibitors-shampa-das_en.pdf"},
    {"id":"24086","name":"Draft guideline on the evaluation of medicinal products for cardiovascular disease prevention","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/CHMP/EWP/311890/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-medicinal-products-cardiovascular-disease-prevention_en.pdf"},
    {"id":"24087","name":"Report from the conference on the outcome of the evaluation of the European Medicines Agency","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-03-24T01:00:00Z","last_updated_date":"2011-03-24T01:00:00Z","reference_number":"EMA/373239/2010","document_url":"https://www.ema.europa.eu/en/documents/report/report-conference-outcome-evaluation-european-medicines-agency_en.pdf"},
    {"id":"24089","name":"Agenda - CAT agenda of the 20-21 April 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-04-22T12:15:00Z","last_updated_date":"2016-04-22T12:15:00Z","reference_number":"EMA/CAT/286924/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-20-21-april-2016-meeting_en.pdf"},
    {"id":"24092","name":"Cyfluthrin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/746/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cyfluthrin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"24095","name":"Presentation - Ph2a dose selection based on the relationship between PK and target occupancy (Mona Alameddine, Patricia Sanwald Ducray)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ph2a-dose-selection-based-relationship-between-pk-and-target-occupancy-mona-alameddine-patricia-sanwald-ducray_en.pdf"},
    {"id":"24096","name":"Presentation - CVMP activities regarding antimicrobials: on-going and recent activities (Helen Jukes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-activities-regarding-antimicrobials-going-and-recent-activities-helen-jukes_en.pdf"},
    {"id":"24099","name":"Overview of comments received on 'Procedure on the publication of Committee on Herbal Medicinal Products public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof a...","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-07-20T02:00:00Z","last_updated_date":"2011-07-20T02:00:00Z","reference_number":"EMA/HMPC/495353/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-procedure-publication-committee-herbal-medicinal-products-public-statements-when-community-herbal-monographs-herbal-substances-preparations-andor-combinations-thereof_en.pdf"},
    {"id":"24100","name":"EU/3/18/1995: Public summary of opinion on orphan designation: Larotrectinib for the treatment of salivary gland cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-08T02:00:00Z","last_updated_date":"2019-10-24T02:00:00Z","reference_number":"EMA/126933/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181995-public-summary-opinion-orphan-designation-larotrectinib-treatment-salivary-gland-cancer_en.pdf"},
    {"id":"24101","name":"Presentation - Animal infection models: identifying the pharmacologic determinants of efficacy (Sujata M. Bhavnani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-animal-infection-models-identifying-pharmacologic-determinants-efficacy-sujata-m-bhavnani_en.pdf"},
    {"id":"24104","name":"Committee for veterinary medicinal products: 45th meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1999-07-15T14:39:21Z","last_updated_date":"1999-07-15T14:39:21Z","reference_number":"EMEA/CVMP/442/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-45th-meeting_en.pdf"},
    {"id":"24107","name":"Paracetamol Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2017-12-11T10:35:00Z","reference_number":"EMA/PRAC/460935/2016 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-timetable-procedure_en.pdf"},
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    {"id":"24181","name":"Harvoni recommended for the treatment of chronic hepatitis C","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/584056/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/harvoni-recommended-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"24182","name":"Guideline on requirements for Plasma Master File (PMF) Certification","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-02-26T01:00:00Z","last_updated_date":"2004-02-26T01:00:00Z","reference_number":"CPMP/BMP/4663/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-plasma-master-file-pmf-certification_en.pdf"},
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    {"id":"24225","name":"Divergent position on a CVMP opinion on an Article 33(4) referral of Directive 2001/82/EC for Gutal 1000 g/kg premix for medicated feeding stuff for piglets (EMEA/V/A/108)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-11-26T01:00:00Z","last_updated_date":"2015-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-334-referral-directive-200182ec-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-emeava108_en.pdf"},
    {"id":"24226","name":"Withdrawal assessment report for Issarlos","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/CHMP/710310/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-issarlos_en.pdf"},
    {"id":"24228","name":"Agenda - CAT agenda of the 15-16 June 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-06-19T19:10:00Z","last_updated_date":"2017-06-19T19:10:00Z","reference_number":"EMA/CAT/344401/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-16-june-2017-meeting_en.pdf"},
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    {"id":"24233","name":"Recommendation to suspend marketing authorisations for hydroxyethyl starch solutions to be re-examined","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"EMA/349341/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/recommendation-suspend-marketing-authorisations-hydroxyethyl-starch-solutions-be-re-examined_en.pdf"},
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    {"id":"24238","name":"Presentation - Draft good-pharmacovigilance-practice module XV: Safety communications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-good-pharmacovigilance-practice-module-xv-safety-communications_en.pdf"},
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    {"id":"24240","name":"Magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"24243","name":"Draft Community herbal monograph on Mentha x piperita L., aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-05-08T02:00:00Z","last_updated_date":"2007-05-08T02:00:00Z","reference_number":"EMEA/HMPC/349466/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-mentha-x-piperita-l-aetheroleum_en.pdf"},
    {"id":"24245","name":"EMEA-coordinated PROTECT project has been accepted for funding bythe Innovative Medicines Initiative Joint Undertaking","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-04-29T02:00:00Z","last_updated_date":"2009-04-29T02:00:00Z","reference_number":"EMEA/230677/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-coordinated-protect-project-has-been-accepted-funding-bythe-innovative-medicines-initiative-joint-undertaking_en.pdf"},
    {"id":"24246","name":"Presentation - Paediatric osteoporosis - regulatory issues (Viveca Odlind)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-09T02:00:00Z","last_updated_date":"2014-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-osteoporosis-regulatory-issues-viveca-odlind_en.pdf"},
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    {"id":"24290","name":"European Medicines Agency certificates of medicinal products - instructions on how to fill in the application form","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-30T02:00:00Z","last_updated_date":"2023-01-16T15:20:00Z","reference_number":"EMA/193330/2014 Rev.15","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-certificates-medicinal-products-instructions-how-fill-application-form_en.pdf"},
    {"id":"24291","name":"Overview of comments received on paediatric addendum to CHMP guidance on clinical investigation of medicinal products in the treatment of lipid disorders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-06T17:00:00Z","last_updated_date":"2012-11-06T17:00:00Z","reference_number":"EMA/CHMP/638198/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-paediatric-addendum-chmp-guidance-clinical-investigation-medicinal-products-treatment-lipid-disorders_en.pdf"},
    {"id":"24294","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 28 to 30 May 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-05-31T02:00:00Z","last_updated_date":"2002-05-31T02:00:00Z","reference_number":"EMEA/CPMP/2341/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-28-30-may-2002_en.pdf"},
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    {"id":"24297","name":"Questions and answers on recommendation for the refusal of the marketing authorisation for Ceplene","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/CHMP/125792/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-ceplene_en.pdf"},
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    {"id":"24306","name":"Presentation - How to improve the reliability of single arm trials (Paolo Bruzzi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T02:00:00Z","last_updated_date":"2016-08-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-improve-reliability-single-arm-trials-paolo-bruzzi_en.pdf"},
    {"id":"24307","name":"Presentation - Availability of veterinary vaccines: Industry perspectives (Frà©dà©ric Descamps)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T02:00:00Z","last_updated_date":"2017-03-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-availability-veterinary-vaccines-industry-perspectives-fracdacric-descamps_en.pdf"},
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    {"id":"24309","name":"Presentation - Assessment of a MAA: Awareness of the PIP recommendation: Generic applications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-assessment-maa-awareness-pip-recommendation-generic-applications_en.pdf"},
    {"id":"24310","name":"Azagly-nafarelin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-02-01T01:00:00Z","last_updated_date":"2002-02-01T01:00:00Z","reference_number":"EMEA/MRL/832/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/azagly-nafarelin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"24311","name":"Presentation - Centralised procedure at the European Medicines Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T16:00:00Z","last_updated_date":"2016-02-15T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-centralised-procedure-european-medicines-agency_en.pdf"},
    {"id":"24312","name":"Communication on reporting of suspected adverse reactions occurring in the European Union by competent authorities in Member States to the World Health Organization","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-27T13:21:00Z","last_updated_date":"2013-09-27T13:21:00Z","reference_number":"EMA/573249/2013","document_url":"https://www.ema.europa.eu/en/documents/other/communication-reporting-suspected-adverse-reactions-occurring-european-union-competent-authorities-member-states-world-health-organization_en.pdf"},
    {"id":"24314","name":"Presentation - European Medicines Agency policy on the handling of conflicts of interests of scientific committees’ members and experts","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-policy-handling-conflicts-interests-scientific-committees-members-and-experts_en.pdf"},
    {"id":"24318","name":"Proposal for European Medicines Agency’s involvement in the 9th IMI Call “WEBAE - leveraging emerging technology for pharmacovigilance”","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T02:00:00Z","last_updated_date":"2013-09-25T02:00:00Z","reference_number":"EMA/564336/2013","document_url":"https://www.ema.europa.eu/en/documents/other/proposal-european-medicines-agencys-involvement-9th-imi-call-webae-leveraging-emerging-technology-pharmacovigilance_en.pdf"},
    {"id":"24320","name":"CVMP post-authorisation summary of positive opinion for Suprelorin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-09-16T02:00:00Z","last_updated_date":"2011-09-16T02:00:00Z","reference_number":"EMA/CVMP/407323/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-suprelorin_en.pdf-0"},
    {"id":"24322","name":"European Medicines Agency/Committee for Medicinal Products for Human Use Working Group with Patients' Organisations - Outcome of discussions: Recommendations and proposals for action","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2005-03-17T01:00:00Z","last_updated_date":"2005-03-17T01:00:00Z","reference_number":"EMEA/149479/2004 Final","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencycommittee-medicinal-products-human-use-working-group-patients-organisations-outcome-discussions-recommendations-and-proposals-action_en.pdf"},
    {"id":"24323","name":"Public declaration of interests and confidentiality undertaking of European Medicines Agency scientific committees' members and experts - prefilled sample form (version 4)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T11:20:00Z","last_updated_date":"2021-02-02T11:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/public-declaration-interests-and-confidentiality-undertaking-european-medicines-agency-scientific-committees-members-and-experts-prefilled-sample-form-version-4_en.pdf"},
    {"id":"24325","name":"Agenda - FP7 Small-population research methods projects and regulatory application workshop","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-02-06T16:40:00Z","last_updated_date":"2017-03-28T17:33:00Z","reference_number":"EMA/849195/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fp7-small-population-research-methods-projects-and-regulatory-application-workshop_en.pdf"},
    {"id":"24329","name":"Assessment report for Baxter dialysis solutions (US site)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"EMA/488426/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-baxter-dialysis-solutions-us-site_en.pdf"},
    {"id":"24333","name":"Agenda - First Workshop on Advanced Therapy Medicinal Products (ATMPs)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-03-09T00:09:21Z","last_updated_date":"2009-03-09T00:09:21Z","reference_number":"EMEA/119832/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-workshop-advanced-therapy-medicinal-products-atmps_en.pdf"},
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    {"id":"24426","name":"Committee for Medicinal Products for Human Use (CHMP) - May 2011 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/CHMP/403396/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-may-2011-plenary-meeting-monthly-report_en.pdf"},
    {"id":"24427","name":"Presentation - Global dementia integrated development (Raj Long)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-global-dementia-integrated-development-raj-long_en.pdf"},
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    {"id":"24432","name":"Minutes of the European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 16 September 20...","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"EMA/563152/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-16-september-20_en.pdf"},
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    {"id":"24434","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the September 2008 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-09-11T02:09:21Z","last_updated_date":"2008-09-11T02:09:21Z","reference_number":"EMEA/COMP/479052/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-september-2008-meeting_en.pdf"},
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    {"id":"24443","name":"Opinion of the HMPC on a European Union herbal monograph on Vaccinium myrtillus L., fructus siccus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"EMA/HMPC/642020/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-vaccinium-myrtillus-l-fructus-siccus_en.pdf"},
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    {"id":"24561","name":"Overview of comments received on European Union herbal monograph on Carum carvi L., fructus","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/HMPC/268114/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-carum-carvi-l-fructus_en.pdf"},
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    {"id":"24568","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Vienna","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-vienna_en.pdf-0"},
    {"id":"24569","name":"Committee on herbal medicinal products (HMPC): Meeting report, 21-22 July 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-07-29T02:00:00Z","last_updated_date":"2005-07-29T02:00:00Z","reference_number":"EMEA/HMPC/243465/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-21-22-july-2005_en.pdf"},
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    {"id":"24579","name":"Presentation - Session VI - Neonatal Necrotizing Enterocolitis (NEC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-18T02:00:00Z","last_updated_date":"2016-10-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-vi-neonatal-necrotizing-enterocolitis-nec_en.pdf"},
    {"id":"24580","name":"Presentation - Discovery and development of PML treatments, Teresa Compton","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-discovery-and-development-pml-treatments-teresa-compton_en.pdf"},
    {"id":"24581","name":"EU/3/02/108: Public summary of positive opinion for orphan designation of myristoylated-peptidyl-recombinant SCR1-3 of human complement receptor type I for the prevention of post transplantation graft dysfunction","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"A/COMP/1498/02 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302108-public-summary-positive-opinion-orphan-designation-myristoylated-peptidyl-recombinant-scr1-3-human-complement-receptor-type-i-prevention-post-transplantation-graft-dysfunction_en.pdf"},
    {"id":"24582","name":"Presentation - Closing remarks (Spiros Vamvakas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-closing-remarks-spiros-vamvakas_en.pdf"},
    {"id":"24585","name":"Ganciclovir: List of nationally authorised medicinal products - PSUSA/00001516/201606","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-16T10:53:00Z","last_updated_date":"2017-02-16T10:57:07Z","reference_number":"EMA/112843/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ganciclovir-list-nationally-authorised-medicinal-products-psusa00001516201606_en.pdf"},
    {"id":"24587","name":"Withdrawal letter : Glivec","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-10-18T02:00:00Z","last_updated_date":"2006-10-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-glivec_en.pdf"},
    {"id":"24588","name":"Presentation - Expert meeting on paediatric development of fixed-dose combinations for the treatment of the human immunodeficiency virus (HIV) (Thorsten Olski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T17:00:00Z","last_updated_date":"2016-05-27T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-expert-meeting-paediatric-development-fixed-dose-combinations-treatment-human-immunodeficiency-virus-hiv-thorsten-olski_en.pdf"},
    {"id":"24590","name":"Overview of comments received on 'Concept paper on extrapolation of efficacy and safety in medicine development'","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T15:47:00Z","last_updated_date":"2013-04-23T15:47:00Z","reference_number":"EMA/184035/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-concept-paper-extrapolation-efficacy-and-safety-medicine-development_en.pdf"},
    {"id":"24591","name":"EU/3/17/1957: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene for the treatment of Huntington's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/828668/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171957-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-5-encoding-microrna-targeted-human-huntingtin-gene-treatment-huntingtons-disease_en.pdf"},
    {"id":"24592","name":"Thiabendazole: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/thiabendazole-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"24594","name":"Cyproheptadine: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000902/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-13T13:00:00Z","last_updated_date":"2016-10-17T20:37:50Z","reference_number":"EMA/756159/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproheptadine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000902201412_en.pdf"},
    {"id":"24595","name":"Agenda for the 79th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/MB/685719/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-79th-meeting-management-board_en.pdf"},
    {"id":"24596","name":"Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-03-28T17:10:00Z","last_updated_date":"2014-03-28T17:10:00Z","reference_number":"EMA/CHMP/153191/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-medicinal-products-intended-treatment-chronic-primary-immune-thrombocytopenia_en.pdf"},
    {"id":"24597","name":"COMP meeting report on the review of applications for orphan designation: April 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-04-26T13:00:00Z","last_updated_date":"2018-04-26T13:00:00Z","reference_number":"EMA/COMP/145093/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-april-2018_en.pdf"},
    {"id":"24598","name":"Committee for medicinal products for veterinary use: Meeting of 6-8 November 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-09T12:49:21Z","last_updated_date":"2008-11-09T12:49:21Z","reference_number":"EMEA/CVMP/498760/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-6-8-november-2007_en.pdf"},
    {"id":"24600","name":"Questions and answers on shortcomings in quality assurance at Ben Venue Laboratories","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-12-13T17:00:00Z","last_updated_date":"2011-12-13T17:00:00Z","reference_number":"EMA/946321/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-shortcomings-quality-assurance-ben-venue-laboratories_en.pdf"},
    {"id":"24603","name":"Regulatory Requirements for Viral Shedding Studies for Gene Therapy Vectors in Switzerland - Andreas Marti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/regulatory-requirements-viral-shedding-studies-gene-therapy-vectors-switzerland-andreas-marti_en.pdf"},
    {"id":"24604","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T15:13:00Z","last_updated_date":"2018-07-05T15:13:00Z","reference_number":"EMA/374249/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-may-2018_en.pdf"},
    {"id":"24606","name":"Presentation - Combined industry view on EudraVigilance developments and access","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:12Z","last_updated_date":"2011-06-24T22:06:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-combined-industry-view-eudravigilance-developments-and-access_en.pdf"},
    {"id":"24607","name":"Organisational matters - CHMP meeting 16-19 November 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-11-27T12:30:00Z","last_updated_date":"2015-11-27T12:30:00Z","reference_number":"EMA/38748/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-16-19-november-2015_en.pdf"},
    {"id":"24609","name":"Presentation - The future partly FAIR, partly Cloudy (Barend Mons)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-future-partly-fair-partly-cloudy-barend-mons_en.pdf"},
    {"id":"24612","name":"EU/3/11/923: Public summary of opinion on orphan designation: L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2020-12-04T16:00:00Z","reference_number":"EMA/COMP/793868/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311923-public-summary-opinion-orphan-designation-l-cysteine-l-leucyl-l-alpha-glutamyl-l-alpha-glutamyl-l-lysyl-l-lysylglycyl-l-asparaginyl-l-tyrosyl-l-valyl-l-valyl-l-threonyl-l-alpha-aspartyl-l_en.pdf"},
    {"id":"24613","name":"Eletriptan: List of nationally authorised medicinal products - PSUSA/00001204/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-08T16:00:00Z","last_updated_date":"2016-11-08T16:00:00Z","reference_number":"EMA/735253/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/eletriptan-list-nationally-authorised-medicinal-products-psusa00001204201602_en.pdf"},
    {"id":"24614","name":"Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-07-24T14:00:00Z","last_updated_date":"2014-07-24T14:00:00Z","reference_number":"EMA/440549/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_en.pdf-0"},
    {"id":"24616","name":"Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21 September 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-09-21T02:09:21Z","last_updated_date":"2006-09-21T02:09:21Z","reference_number":"EMEA/376832/2006/corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-18-21-september-2006_en.pdf"},
    {"id":"24618","name":"Periodic Safety Update Report (PSUR) repository mandatory use: questions and answers","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-06-10T12:00:00Z","last_updated_date":"2016-06-10T12:00:00Z","reference_number":"EMA/395434/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/periodic-safety-update-report-psur-repository-mandatory-use-questions-and-answers_en.pdf"},
    {"id":"24621","name":"Initial notices for parallel distribution - 2007","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:00:00Z","last_updated_date":"2008-06-26T02:00:00Z","reference_number":"EMEA/311899/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2007_en.pdf"},
    {"id":"24622","name":"Presentation - Objectives - Training session for patients and consumers involved in EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-training-session-patients-and-consumers-involved-ema_en.pdf"},
    {"id":"24623","name":"Committee for medicinal products for human use, summary of positive opinion for Pramipexole Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-10-23T02:00:00Z","last_updated_date":"2008-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-pramipexole-teva_en.pdf"},
    {"id":"24628","name":"CHMP summary of positive opinion for Alecensa","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-alecensa_en.pdf"},
    {"id":"24629","name":"CHMP summary of positive opinion for Trobalt","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2018-11-19T02:00:00Z","reference_number":"EMA/31145/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trobalt_en.pdf"},
    {"id":"24633","name":"Committee for Proprietary Medicinal Products (CPMP) 10th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1995-11-29T01:00:00Z","last_updated_date":"1995-11-29T01:00:00Z","reference_number":"CPMP/832/95","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-10th-plenary-meeting_en.pdf"},
    {"id":"24634","name":"Presentation - Gene therapy ATMPs: High Council for the biotechnology’s scientific committee expertise for contained use and deliberate release (Nils Braun and Jean-Christophe Pagà¨s)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gene-therapy-atmps-high-council-biotechnologys-scientific-committee-expertise-contained-use-and-deliberate-release-nils-braun-and-jean-christophe-pagas_en.pdf"},
    {"id":"24636","name":"CHMP summary of positive opinion for Zalviso","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T14:00:00Z","last_updated_date":"2022-09-27T11:28:00Z","reference_number":"EMA/CHMP/471000/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zalviso_en.pdf"},
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    {"id":"24640","name":"Presentation - EudraVigilance reporting process for users: Create and send individual case safety reports (ICSRs) using EVWEB - Training Module EV-M3d - Part II","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-08-02T18:10:00Z","last_updated_date":"2017-08-02T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-reporting-process-users-create-and-send-individual-case-safety-reports-icsrs-using-evweb-training-module-ev-m3d-part-ii_en.pdf"},
    {"id":"24642","name":"Final report on the adaptive pathways pilot","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-08-03T14:00:00Z","last_updated_date":"2016-08-03T14:00:00Z","reference_number":"EMA/276376/2016","document_url":"https://www.ema.europa.eu/en/documents/report/final-report-adaptive-pathways-pilot_en.pdf"},
    {"id":"24645","name":"Report of second EMA-EFPIA annual bilateral meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-09-18T02:00:00Z","last_updated_date":"2017-09-18T02:00:00Z","reference_number":"EMA/602747/2017","document_url":"https://www.ema.europa.eu/en/documents/report/report-second-ema-efpia-annual-bilateral-meeting_en.pdf"},
    {"id":"24646","name":"EU/3/08/527: Public summary of positive opinion for orphan designation of recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class for the treatment of systemic-onset juvenile idiopathic arthritis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2015-02-12T13:00:00Z","reference_number":"EMEA/COMP/103869/2008 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308527-public-summary-positive-opinion-orphan-designation-recombinant-human-monoclonal-antibody-human-il-1beta-igg1k-class-treatment-systemic-onset-juvenile-idiopathic-arthritis_en.pdf"},
    {"id":"24648","name":"Eudravigilance registration user management","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2017-10-23T16:15:00Z","reference_number":"EMA/404288/2016","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-registration-user-management_en.pdf"},
    {"id":"24652","name":"EU/3/08/580: Public summary of positive opinion for orphan designation of filgrastim for the treatment of spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMEA/COMP/488916/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308580-public-summary-positive-opinion-orphan-designation-filgrastim-treatment-spinal-cord-injury_en.pdf"},
    {"id":"24654","name":"Hydroxyzine Article-31 referral - PRAC assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T12:00:00Z","last_updated_date":"2015-04-20T12:00:00Z","reference_number":"EMA/154392/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"24657","name":"Agenda - Patients and Consumers Working Party (PCWP) meeting with all EMA eligible patient/consumer organisations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-17T16:55:00Z","last_updated_date":"2017-12-11T16:55:00Z","reference_number":"EMA/663268/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patients-and-consumers-working-party-pcwp-meeting-all-ema-eligible-patientconsumer-organisations_en.pdf"},
    {"id":"24658","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - May 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-05-31T02:00:00Z","last_updated_date":"2008-05-31T02:00:00Z","reference_number":"EMEA/281942/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-may-2008_en.pdf"},
    {"id":"24659","name":"Role of EMA in Patient Registries, Dr Jan Petracek","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/role-ema-patient-registries-dr-jan-petracek_en.pdf"},
    {"id":"24660","name":"Germanium (68Ge) chloride / gallium (68Ga) chloride: List of nationally authorised medicinal products - PSUSA/00010364/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-09T18:00:00Z","last_updated_date":"2016-11-09T18:00:00Z","reference_number":"EMA/740315/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/germanium-68ge-chloride-gallium-68ga-chloride-list-nationally-authorised-medicinal-products-psusa00010364201603_en.pdf"},
    {"id":"24661","name":"EU/3/11/935: Public summary of opinion on orphan designation: Interferon gamma for the treatment of Friedreich's ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/COMP/849100/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311935-public-summary-opinion-orphan-designation-interferon-gamma-treatment-friedreichs-ataxia_en.pdf"},
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    {"id":"24668","name":"Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 109 to 126","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-10-02T19:00:00Z","last_updated_date":"2014-10-02T19:00:00Z","reference_number":"EMA/349245/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-publication-and-access-clinical-trial-data-ema2408102013-stakeholder-109-126_en.pdf"},
    {"id":"24670","name":"Loperamide: List of nationally authorised medicinal products - PSUSA/00001903/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:40:00Z","last_updated_date":"2017-01-20T16:40:00Z","reference_number":"EMA/36361/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/loperamide-list-nationally-authorised-medicinal-products-psusa00001903201605_en.pdf"},
    {"id":"24671","name":"1st European SME week 2009\n\nEMEA Roundtable with SME stakeholder organisations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-05-08T02:00:00Z","last_updated_date":"2009-05-08T02:00:00Z","reference_number":"EMEA/290264/2009","document_url":"https://www.ema.europa.eu/en/documents/report/1st-european-sme-week-2009-emea-roundtable-sme-stakeholder-organisations_en.pdf"},
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    {"id":"24677","name":"EU/3/09/624: Public summary of positive opinion for orphan designation of autologous tumour-derived gp96 heat shock protein-peptide complex for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-12T02:00:00Z","last_updated_date":"2009-05-12T02:00:00Z","reference_number":"EMEA/COMP/157828/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309624-public-summary-positive-opinion-orphan-designation-autologous-tumour-derived-gp96-heat-shock-protein-peptide-complex-treatment-glioma_en.pdf"},
    {"id":"24678","name":"EU/3/15/1572: Public summary of opinion on orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of chronic lymphocytic l...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/COMP/697123/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151572-public-summary-opinion-orphan-designation-autologous-t-cells-transduced-retroviral-vector-encoding-anti-cd19-cd28cd3-zeta-chimeric-antigen-receptor-treatment-chronic-lymphocytic-l_en.pdf"},
    {"id":"24679","name":"Public statement on Valtropin: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-08-14T18:45:00Z","last_updated_date":"2012-08-14T18:45:00Z","reference_number":"EMA/356690/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-valtropin-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"24682","name":"European Medicines Agency makes recommendations to minimise risk of nephrogenic systemic fibrosis with gadolinium-containing contrast agents","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-11-20T00:09:21Z","last_updated_date":"2009-11-20T00:09:21Z","reference_number":"EMEA/CHMP/739818/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-makes-recommendations-minimise-risk-nephrogenic-systemic-fibrosis-gadolinium-containing-contrast-agents_en.pdf"},
    {"id":"24684","name":"Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T13:00:00Z","last_updated_date":"2016-12-14T13:13:00Z","reference_number":"EMA/807599/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-systemic-use-list-nationally-authorised-medicinal-products-psusa00010377201604_en.pdf"},
    {"id":"24685","name":"Final Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-08-24T17:00:00Z","last_updated_date":"2012-08-24T17:00:00Z","reference_number":"EMA/HMPC/571119/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-glycyrrhiza-glabra-l-andor-glycyrrhiza-inflata-bat-andor-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"24686","name":"Macrogol 3350: List of nationally authorised medicinal products - PSUSA/00001924/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T14:41:00Z","last_updated_date":"2017-02-02T14:42:24Z","reference_number":"EMA/77705/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/macrogol-3350-list-nationally-authorised-medicinal-products-psusa00001924201605_en.pdf"},
    {"id":"24687","name":"Presentation - European Patients Forum member survey on pharmacovigilance. First results and tentative conclusions (Kaisa Immonen-Charalambous)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-patients-forum-member-survey-pharmacovigilance-first-results-and-tentative-conclusions-kaisa-immonen-charalambous_en.pdf"},
    {"id":"24688","name":"Overview of comments received on draft guideline on the development of new medicinal products for the treatment of ulcerative colitis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2008-02-21T01:00:00Z","reference_number":"EMEA/468539/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-development-new-medicinal-products-treatment-ulcerative-colitis_en.pdf"},
    {"id":"24689","name":"GMP requirements, Dr Walter Janssens","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/gmp-requirements-dr-walter-janssens_en.pdf"},
    {"id":"24693","name":"Diclofenac Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-27T01:00:00Z","last_updated_date":"2013-11-27T01:00:00Z","reference_number":"EMEA/H/A-31/1344","document_url":"https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diclofenac-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diclofenac-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diclofenac-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diclofenac-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diclofenac-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diclofenac-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diclofenac-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diclofenac-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/diclofenac-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diclofenac-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diclofenac-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diclofenac-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diclofenac-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diclofenac-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diclofenac-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diclofenac-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diclofenac-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diclofenac-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diclofenac-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diclofenac-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diclofenac-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diclofenac-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/diclofenac-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/diclofenac-article-31-referral-annex-iii_no.pdf"}},
    {"id":"24694","name":"EU/3/05/329: Public summary of positive opinion for orphan designation of peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN) treatment of localised scleroderma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/317440/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305329-public-summary-positive-opinion-orphan-designation-peptide-144-tgf-beta1-inhibitor-tsldasiiwammqn-treatment-localised-scleroderma_en.pdf"},
    {"id":"24696","name":"New medicine to treat heart failure recommended for approval","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-09-25T14:00:00Z","last_updated_date":"2015-09-25T14:00:00Z","reference_number":"EMA/CHMP/628846/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-treat-heart-failure-recommended-approval_en.pdf"},
    {"id":"24697","name":"Chapter 3: XEVPRM technical specifications, user guidance and practical examples of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-01T21:19:00Z","last_updated_date":"2012-03-05T12:00:00Z","reference_number":"EMA/721644/2011","document_url":"https://www.ema.europa.eu/en/documents/other/chapter-3-xevprm-technical-specifications-user-guidance-and-practical-examples-detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf"},
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    {"id":"24706","name":"EU/3/02/113: Public summary of positive opinion for orphan designation of mitotane for the treatment of adrenal cortical carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T01:00:00Z","last_updated_date":"2005-11-29T01:00:00Z","reference_number":"EMEA/COMP/1640/02 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302113-public-summary-positive-opinion-orphan-designation-mitotane-treatment-adrenal-cortical-carcinoma_en.pdf"},
    {"id":"24709","name":"Framework of collaboration with academia - Discussion session","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-01T02:00:00Z","last_updated_date":"2015-09-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/framework-collaboration-academia-discussion-session_en.pdf"},
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    {"id":"24714","name":"EU/3/11/944: Public summary of positive opinion for orphan designation: N,N'-bis(2-mercaptoethyl)isophthalamide for the treatment of mercury toxicity","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2015-03-24T15:00:00Z","reference_number":"EMA/COMP/929337/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311944-public-summary-positive-opinion-orphan-designation-nn-bis2-mercaptoethylisophthalamide-treatment-mercury-toxicity_en.pdf"},
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    {"id":"24716","name":"EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T01:00:00Z","last_updated_date":"2018-03-07T01:00:00Z","reference_number":"EMA/134289/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-immediate-suspension-and-recall-multiple-sclerosis-medicine-zinbryta_en.pdf"},
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    {"id":"24720","name":"Withdrawal assessment report for Draxxin: Extension of indication for Bordetella bronchiseptica","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T02:00:00Z","last_updated_date":"2012-07-04T02:00:00Z","reference_number":"EMA/323019/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-draxxin-extension-indication-bordetella-bronchiseptica_en.pdf"},
    {"id":"24722","name":"Final European Union herbal monograph on Glycine max (L.) Merr., oleum raffinatum","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2017-03-03T10:19:00Z","last_updated_date":"2017-03-03T10:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-glycine-max-l-merr-oleum-raffinatum_en.pdf"},
    {"id":"24723","name":"Bayovac IBR Marker Vivum Article-78 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-05T02:00:00Z","last_updated_date":"2014-08-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bayovac-ibr-marker-vivum-article-78-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"24724","name":"Meeting of the EMEA working party on herbal medicinal products 2 and 3 February 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-02-18T01:00:00Z","last_updated_date":"2004-02-18T01:00:00Z","reference_number":"EMEA/HMPWP/533/04 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-2-and-3-february-2004_en.pdf"},
    {"id":"24726","name":"Tetrazepam-containing medicines - Article-107i procedure - Review of tetrazepam-containing medicines started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T13:00:00Z","last_updated_date":"2013-01-11T13:00:00Z","reference_number":"EMEA/H/A-107i/1352","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-review-tetrazepam-containing-medicines-started_en.pdf"},
    {"id":"24727","name":"Agenda - PRAC draft agenda of meeting 7-10 September 2015","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-09-07T20:00:00Z","last_updated_date":"2015-09-07T20:00:00Z","reference_number":"EMA/PRAC/596669/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-7-10-september-2015_en.pdf"},
    {"id":"24728","name":"Presentation - European Union collaborative framework for patient registries: Pilot phase (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-union-collaborative-framework-patient-registries-pilot-phase-xavier-kurz_en.pdf"},
    {"id":"24729","name":"Presentation - Module 1 - Setting the scene: Introduction to the EU regulatory network","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-1-setting-scene-introduction-eu-regulatory-network_en.pdf"},
    {"id":"24730","name":"EU/3/07/449: Public summary of positive opinion for orphan designation of everolimus for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMEA/COMP/202020/2007 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307449-public-summary-positive-opinion-orphan-designation-everolimus-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"24734","name":"Xofigo Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T13:00:00Z","last_updated_date":"2017-12-01T13:00:00Z","reference_number":"EMA/789952/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/xofigo-article-20-procedure-review-started_en.pdf"},
    {"id":"24735","name":"Presentation - Strengthening interaction with stakeholders (Marie-Agnes Heine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-interaction-stakeholders-marie-agnes-heine_en.pdf"},
    {"id":"24738","name":"Presentation - The experience of biotech SMEs with Commission Regulation (EC) No 2049/2005 (SME Regulation) : The Europa Association for Bioindustries (EuropaBio)  (Miriam Gargesi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-biotech-smes-commission-regulation-ec-no-20492005-sme-regulation-europa-association-bioindustries-europabio-miriam-gargesi_en.pdf"},
    {"id":"24740","name":"Standard operating procedure for rapporteur / co-rapporteur appointment for re-examination of a CHMP opinion","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-12-05T01:00:00Z","last_updated_date":"2012-09-26T18:35:15Z","reference_number":"SOP/H/3175","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-rapporteur-co-rapporteur-appointment-re-examination-chmp-opinion_en.pdf"},
    {"id":"24741","name":"Mandate, objectives and rules of procedure for the Inter-Committee Scientific Advisory Group (SAG) for Oncology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T16:50:00Z","last_updated_date":"2014-11-24T16:50:00Z","reference_number":"EMA/742599/2012","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-inter-committee-scientific-advisory-group-sag-oncology_en.pdf"},
    {"id":"24742","name":"Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Topotecan SUN (topotecan)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-02-17T01:00:00Z","last_updated_date":"2011-02-17T01:00:00Z","reference_number":"EMA/134567/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/sun-pharmaceutical-industries-europe-bv-withdraws-its-marketing-authorisation-application-topotecan-sun-topotecan_en.pdf"},
    {"id":"24744","name":"Idebenone: List of nationally authorised medicinal products - PSUSA/00001721/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-07-20T02:00:00Z","last_updated_date":"2016-10-17T17:46:44Z","reference_number":"EMA/485797/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/idebenone-list-nationally-authorised-medicinal-products-psusa00001721201409_en.pdf"},
    {"id":"24745","name":"Report from the ADHOC working group meeting on herbal medicinal products: 1997 1998","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-02-10T01:00:00Z","last_updated_date":"1999-02-10T01:00:00Z","reference_number":"EMEA/HMPWG/25/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/report-adhoc-working-group-meeting-herbal-medicinal-products-1997-1998_en.pdf"},
    {"id":"24746","name":"Presentation - Key considerations in risk-management plans (Maarten Lagendijk)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-considerations-risk-management-plans-maarten-lagendijk_en.pdf"},
    {"id":"24747","name":"EU/3/17/1876: Public summary of opinion on orphan designation: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-29T02:00:00Z","last_updated_date":"2017-06-29T02:00:00Z","reference_number":"EMA/259560/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171876-public-summary-opinion-orphan-designation-sodium-1r3r4r5s-3-2-n-acetylamino-2-deoxy-3-o-1s-1-carboxylato-2-cyclohexylethyl-beta-d-galactopyranosyloxy-4-6-deoxy-alpha-l-galactopyranosyl_en.pdf"},
    {"id":"24748","name":"Presentation - European Surveillance of Veterinary Antimicrobial Consumption 2012 - Results and state of play","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-03-29T12:14:00Z","last_updated_date":"2012-03-29T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-surveillance-veterinary-antimicrobial-consumption-2012-results-and-state-play_en.pdf"},
    {"id":"24753","name":"Technical specifications for open invitation to tender - EMA/2012/03/HR for provision of services for 360 performance evaluation of EMA management\n\nstaff","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-24T09:50:00Z","last_updated_date":"2012-01-24T09:50:00Z","reference_number":"EMA/901316/2011","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-open-invitation-tender-ema201203hr-provision-services-360-performance-evaluation-ema-management-staff_en.pdf"},
    {"id":"24755","name":"Revised guideline on the summary of product characteristics for antimicrobial products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-12T00:09:21Z","last_updated_date":"2007-11-12T00:09:21Z","reference_number":"EMEA/CVMP/SAGAM/383441/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-guideline-summary-product-characteristics-antimicrobial-products_en.pdf"},
    {"id":"24756","name":"Dextromethorphan: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information, and timetable for the implementation - PSUSA/00001009/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-30T14:00:00Z","last_updated_date":"2016-10-17T20:37:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/dextromethorphan-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001009201511_en.pdf"},
    {"id":"24757","name":"Registration form - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations (EFPIA) workshop on the importance of dose finding and dose selection for the successful development, licens...","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-06-23T02:00:00Z","last_updated_date":"2014-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-european-medicines-agencyeuropean-federation-pharmaceutical-industries-and-associations-efpia-workshop-importance-dose-finding-and-dose-selection-successful-development-licens_en.pdf"},
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    {"id":"24813","name":"Micro Therapeutic Research Article-31 referral - Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation...","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-04-19T02:00:00Z","reference_number":"EMA/203466/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-products-which-marketing-authorisations-are-recommended-suspension-and-marketing-authorisation-applications-which-do-not-satisfy-criteria-authorisation_en.pdf"},
    {"id":"24814","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Salix [various species including S. purpurea L.; S. daphnoides Vill.; S. fragilis L.], cortex","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"EMEA/HMPC/66094/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-cortex_en.pdf"},
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    {"id":"24819","name":"Public statement - European Medicines Agency announces regulatory action on COX-2 inhibitors","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-02-17T00:09:21Z","last_updated_date":"2005-02-17T00:09:21Z","reference_number":"EMEA/62838/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-european-medicines-agency-announces-regulatory-action-cox-2-inhibitors_en.pdf"},
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    {"id":"24836","name":"Annex I: Catalogue of assets for donation - Donation of EMA assets no. EMA/2014/28/IS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-08-22T16:05:00Z","reference_number":"Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/annex-i-catalogue-assets-donation-donation-ema-assets-no-ema201428is_en.xls"},
    {"id":"24838","name":"Overview of comments received on draft reflection paper on pharmacogenomic samples, testing and data handling","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-04-02T02:00:00Z","last_updated_date":"2007-04-02T02:00:00Z","reference_number":"EMEA/CHMP/536201/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-reflection-paper-pharmacogenomic-samples-testing-and-data-handling_en.pdf"},
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    {"id":"24897","name":"Organisational matters - CHMP meeting of 29 March - 1 April 2016","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T12:20:00Z","last_updated_date":"2016-04-08T12:20:00Z","reference_number":"EMA/67121/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-29-march-1-april-2016_en.pdf"},
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    {"id":"24908","name":"Overview of comments received on 'guideline on the\n\nevaluation of drugs for the treatment of gastro-oesophageal\n\nreflux disease'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-14T01:00:00Z","last_updated_date":"2011-03-14T01:00:00Z","reference_number":"EMA/131448/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-evaluation-drugs-treatment-gastro-oesophageal-reflux-disease_en.pdf"},
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    {"id":"24911","name":"EU/3/16/1798: Public summary of opinion on orphan designation: Avelumab for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2019-10-15T01:00:00Z","reference_number":"EMA/753360/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161798-public-summary-opinion-orphan-designation-avelumab-treatment-gastric-cancer_en.pdf"},
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    {"id":"24915","name":"CHMP summary of positive opinion for Onivyde","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/478619/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-onivyde_en.pdf"},
    {"id":"24919","name":"EMEA Management Board moves for greater transparency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-06-12T02:09:21Z","last_updated_date":"2006-06-12T02:09:21Z","reference_number":"EMEA/216787/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-management-board-moves-greater-transparency_en.pdf"},
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    {"id":"24936","name":"Session 1 - CMC - Innovator Industry Presentation - Prof. Georg-B. Kresse","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-1-cmc-innovator-industry-presentation-prof-georg-b-kresse_en.pdf"},
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    {"id":"24940","name":"EU/3/17/1893: Public summary of opinion on orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside for the treatment of anti-MAG neuropathy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-16T11:30:00Z","last_updated_date":"2017-08-16T11:30:00Z","reference_number":"EMA/407016/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171893-public-summary-opinion-orphan-designation-polyphenyldisodium-3-o-sulfo-beta-d-glucopyranuronate-1-3-beta-d-galactopyranoside-treatment-anti-mag-neuropathy_en.pdf"},
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    {"id":"24958","name":"News bulletin for small and medium-sized enterprises - Issue 9","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2000-10-19T02:00:00Z","last_updated_date":"2000-10-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-9_en.pdf"},
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    {"id":"24965","name":"Report from EMA industry survey on Brexit preparedness","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T19:13:00Z","last_updated_date":"2018-07-11T17:34:00Z","reference_number":"EMA/450315/2018 Corr. 1*","document_url":"https://www.ema.europa.eu/en/documents/report/report-ema-industry-survey-brexit-preparedness_en.pdf"},
    {"id":"24966","name":"European Medicines Agency and Member States joint implementation checklist","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-20T01:31:00Z","last_updated_date":"2012-06-25T19:04:00Z","reference_number":"EMA/778475/2010","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-and-member-states-joint-implementation-checklist_en.pdf"},
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    {"id":"24972","name":"Draft list of references supporting the assessment of Andrographis paniculata Nees, folium - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-01-25T01:00:00Z","last_updated_date":"2013-01-25T01:00:00Z","reference_number":"EMA/HMPC/320452/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-andrographis-paniculata-nees-folium-first-version_en.pdf"},
    {"id":"24978","name":"Agenda – Stakeholder focus group meeting on availability of lumpy skin disease (LSD) vaccines authorised to European Union (EU) standards","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-01-03T11:00:00Z","last_updated_date":"2017-01-27T11:00:00Z","reference_number":"EMA/CVMP/IWP/661057/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-stakeholder-focus-group-meeting-availability-lumpy-skin-disease-lsd-vaccines-authorised-european-union-eu-standards_en.pdf"},
    {"id":"24980","name":"EU/3/16/1723 : Public summary of opinion on orphan designation: Methotrexate for the treatment of alkaptonuria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161723-public-summary-opinion-orphan-designation-methotrexate-treatment-alkaptonuria_en.pdf"},
    {"id":"24981","name":"Draft assessment report on Ononis spinosa L., radix","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-08-19T02:00:00Z","last_updated_date":"2013-08-19T02:00:00Z","reference_number":"EMA/HMPC/138316/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-ononis-spinosa-l-radix_en.pdf"},
    {"id":"24982","name":"Third pandemic pharmacovigilance weekly update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-12-16T01:00:00Z","last_updated_date":"2009-12-16T01:00:00Z","reference_number":"EMA/821276/2009","document_url":"https://www.ema.europa.eu/en/documents/report/third-pandemic-pharmacovigilance-weekly-update_en.pdf"},
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    {"id":"25093","name":"Superseded overview of comments received on 'Community herbal monograph on Melilotus officinalis (L.) Lam., herba' (EMEA/HMPC/220828/2008)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2018-04-23T02:00:00Z","reference_number":"EMEA/HMPC/220828/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-melilotus-officinalis-l-lam-herba-emeahmpc2208282008_en.pdf"},
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    {"id":"25096","name":"NicOx S.A. withdraws its marketing authorisation application for Beprana (naproxcinod)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-04-20T02:00:00Z","last_updated_date":"2011-04-20T02:00:00Z","reference_number":"EMA/322628/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/nicox-sa-withdraws-its-marketing-authorisation-application-beprana-naproxcinod_en.pdf"},
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    {"id":"25104","name":"Presentation - Quality variations: simplification opportunities and improvement of quality of submissions (Alberto Ganan Jimenez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-16T16:30:00Z","last_updated_date":"2018-01-16T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-variations-simplification-opportunities-and-improvement-quality-submissions-alberto-ganan-jimenez_en.pdf"},
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    {"id":"25113","name":"CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/227560/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_en.pdf"},
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    {"id":"25116","name":"EU GMP Requirements - Good Distribution Practices - Martin Melzer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-20T02:09:21Z","last_updated_date":"2009-10-20T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-gmp-requirements-good-distribution-practices-martin-melzer_en.pdf"},
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    {"id":"25199","name":"European Medicines Agency budget for 2017","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2016-12-19T17:30:00Z","last_updated_date":"2016-12-19T17:30:00Z","reference_number":"EMA/MB/740755/2016","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2017_en.pdf"},
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    {"id":"25267","name":"Ambroxol and bromhexine Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T14:00:00Z","last_updated_date":"2014-04-11T14:00:00Z","reference_number":"EMA/PRAC/189078/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-prac-list-questions_en.pdf"},
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    {"id":"25408","name":"Colistin combinations Article 35 referral - Annexes I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-08-05T02:00:00Z","last_updated_date":"2016-08-05T02:00:00Z","reference_number":"EMA/461505/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/colistin-combinations-article-35-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"25410","name":"Public statement on the use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-02-15T01:00:00Z","last_updated_date":"2007-02-15T01:00:00Z","reference_number":"EMEA/CVMP/SAGAM/184651/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-use-fluoroquinolones-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
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    {"id":"25413","name":"Ketoprofen (topical use only): List of nationally authorised medicinal products - PSUSA/00009205/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T16:00:00Z","last_updated_date":"2017-05-12T16:00:00Z","reference_number":"EMA/2826/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketoprofen-topical-use-only-list-nationally-authorised-medicinal-products-psusa00009205201609_en.pdf"},
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    {"id":"25418","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Viekirax Annex I-III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T01:00:00Z","last_updated_date":"2017-03-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-viekirax-annex-i-iii_no.pdf"}},
    {"id":"25419","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - June 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-07-04T02:00:00Z","last_updated_date":"2011-07-04T02:00:00Z","reference_number":"EMA/CVMP/37837/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-june-2011_en.pdf"},
    {"id":"25420","name":"Inventory of paediatric therapeutic needs: gastroenterology","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2015-10-28T17:20:00Z","last_updated_date":"2015-10-28T17:20:00Z","reference_number":"EMA/PDCO/552359/2015","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-therapeutic-needs-gastroenterology_en.pdf"},
    {"id":"25421","name":"Draft list of references supporting the assessment of Serenoa repens (W. Bartram) Small, fructus","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-12-22T17:40:00Z","last_updated_date":"2014-12-22T17:40:00Z","reference_number":"EMA/HMPC/280080/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"25425","name":"Withdrawal letter: Pioglitazone ratiopharm","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T13:00:00Z","last_updated_date":"2012-04-30T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-pioglitazone-ratiopharm_en.pdf"},
    {"id":"25426","name":"Paracetamol/ibuprofen 500mg/150mg Article-29(4) referral - Questions and answers on Paracetamol/ibuprofen 500mg/150mg film-coated tablets and associated names (tablets containing 500 mg paracetamol and 150 mg ibuprofen)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T02:00:00Z","last_updated_date":"2017-08-18T02:00:00Z","reference_number":"EMA/304852/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamolibuprofen-500mg150mg-article-294-referral-questions-and-answers-paracetamolibuprofen-500mg150mg-film-coated-tablets-and-associated-names-tablets-containing-500-mg-paracetamol-and-150-mg_en.pdf"},
    {"id":"25427","name":"Corlentor and Procoralan Article-20 procedure - European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan 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    {"id":"25455","name":"Public statement on Krystexxa: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/498114/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-krystexxa-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"25456","name":"EU/03/11/919: Public summary of opinion on orphan designation: Clonidine hydrochloride for the prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2015-03-12T16:00:00Z","reference_number":"EMA/COMP/780548/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu0311919-public-summary-opinion-orphan-designation-clonidine-hydrochloride-prevention-oral-mucositis-head-and-neck-cancer-patients-undergoing-radiation-therapy_en.pdf"},
    {"id":"25458","name":"Committee on herbal medicinal products (HMPC): Meeting report, 7 September 2006","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-09-29T02:00:00Z","last_updated_date":"2006-09-29T02:00:00Z","reference_number":"EMEA/HMPC/359284/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-7-september-2006_en.pdf"},
    {"id":"25460","name":"Agenda - Workshop on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-10-28T01:00:00Z","last_updated_date":"2015-11-10T17:00:00Z","reference_number":"EMA/400205/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-use-pharmacokinetics-and-pharmacodynamics-development-antibacterial-medicinal-products_en.pdf"},
    {"id":"25461","name":"Presentation - Improve certainty of regulatory outcome: An incentive identified by stakeholders to foster translation of research into commercial products: A small and medium-sized enterprise perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T12:00:00Z","last_updated_date":"2012-02-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-improve-certainty-regulatory-outcome-incentive-identified-stakeholders-foster-translation-research-commercial-products-small-and-medium-sized-enterprise-perspective_en.pdf"},
    {"id":"25462","name":"Guideline on the clinical investigation of human plasma derived Von Willebrand factor products (CPMP/BPWG/220/02)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-17T00:09:21Z","last_updated_date":"2005-11-17T00:09:21Z","reference_number":"CPMP/BPWG/220/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-human-plasma-derived-von-willebrand-factor-products-cpmpbpwg22002_en.pdf"},
    {"id":"25463","name":"Valproate and related substances Article-31 referral - Annex V","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valproate-and-related-substances-article-31-referral-annex-v_sv.pdf"}},
    {"id":"25464","name":"Draft list of references for assessment of: Eleutherococci radix Eleutherococcus senticosus (Rupr. et Maxim.) Maxim. (eleutherococcus root)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2007-07-05T02:09:21Z","reference_number":"EMEA/249428/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-eleutherococci-radix-eleutherococcus-senticosus-rupr-et-maxim-maxim-eleutherococcus-root_en.pdf"},
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    {"id":"25468","name":"Withdrawal letter: Tysabri","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-tysabri_en.pdf"},
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    {"id":"25470","name":"Carisoprodol - Article 107 procedures - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-15T00:08:21Z","last_updated_date":"2007-11-15T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/carisoprodol-article-107-procedures-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/carisoprodol-article-107-procedures-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/carisoprodol-article-107-procedures-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/carisoprodol-article-107-procedures-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/carisoprodol-article-107-procedures-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/carisoprodol-article-107-procedures-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/carisoprodol-article-107-procedures-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/carisoprodol-article-107-procedures-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/carisoprodol-article-107-procedures-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/carisoprodol-article-107-procedures-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/carisoprodol-article-107-procedures-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/carisoprodol-article-107-procedures-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/carisoprodol-article-107-procedures-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/carisoprodol-article-107-procedures-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/carisoprodol-article-107-procedures-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/carisoprodol-article-107-procedures-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/carisoprodol-article-107-procedures-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/carisoprodol-article-107-procedures-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/carisoprodol-article-107-procedures-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/carisoprodol-article-107-procedures-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/carisoprodol-article-107-procedures-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/carisoprodol-article-107-procedures-annex-i_sv.pdf"}},
    {"id":"25472","name":"Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation - April 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-04-23T18:30:00Z","last_updated_date":"2012-05-03T18:30:00Z","reference_number":"EMA/COMP/175202/2012 Rev.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-meeting-report-review-applications-orphan-designation-april-2012_en.pdf"},
    {"id":"25473","name":"Human medicines highlights - August 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-09-08T16:50:00Z","last_updated_date":"2015-09-08T16:50:00Z","reference_number":"Issue 78","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-august-2015_en.pdf"},
    {"id":"25475","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Cholera vaccine, live attenuated, oral (strain CVD 103-HgR) for prevention of disease caused by V. cholerae serogroup O1","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-11T12:15:00Z","last_updated_date":"2014-12-11T12:15:00Z","reference_number":"EMA/507469/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-cholera-vaccine-live-attenuated-oral-strain-cvd-103-hgr-prevention-disease-caused-v-cholerae-serogroup-o1_en.pdf"},
    {"id":"25476","name":"European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 3","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2016-12-19T17:30:00Z","last_updated_date":"2016-12-19T17:30:00Z","reference_number":"EMA/759287/2009 Revision 3","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-policy-access-eudravigilance-data-medicinal-products-human-use-revision-3_en.pdf"},
    {"id":"25477","name":"Novartis withdraws its marketing authorisation application for Joicela (lumiracoxib)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-04-19T02:00:00Z","last_updated_date":"2011-04-19T02:00:00Z","reference_number":"EMA/309990/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/novartis-withdraws-its-marketing-authorisation-application-joicela-lumiracoxib_en.pdf"},
    {"id":"25480","name":"Withdrawal letter: Effentora","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-effentora_en.pdf"},
    {"id":"25481","name":"Update on a pilot project to collaborate on international good-manufacturing-practice-inspection activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-01-08T01:00:00Z","last_updated_date":"2009-01-08T01:00:00Z","reference_number":"EMEA/INS/GMP/430438/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/update-pilot-project-collaborate-international-good-manufacturing-practice-inspection-activities_en.pdf"},
    {"id":"25483","name":"CHMP summary of positive opinion for Docetaxel Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/CHMP/858298/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-docetaxel-mylan_en.pdf"},
    {"id":"25488","name":"CHMP post-authorisation summary of positive opinion for Zytiga","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"EMA/CHMP/666739/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zytiga_en.pdf-0"},
    {"id":"25489","name":"Report on the pilot European Medicines Agency-Food and Drug Administration good-clinical-practice initiative","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-08-02T17:54:25Z","last_updated_date":"2011-08-02T17:54:25Z","reference_number":"EXT/INS/GCP/56289/2011","document_url":"https://www.ema.europa.eu/en/documents/report/report-pilot-european-medicines-agency-food-and-drug-administration-good-clinical-practice-initiative_en.pdf"},
    {"id":"25492","name":"Draft list of references supporting the assessment of Eschscholzia californica Cham., herba","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2014-07-31T19:15:00Z","last_updated_date":"2014-07-31T19:15:00Z","reference_number":"EMA/HMPC/35559/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-eschscholzia-californica-cham-herba_en.pdf"},
    {"id":"25493","name":"EU/3/06/374: Public summary of positive opinion for orphan designation of methoxsalen for the treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMEA/COMP/132163/2006 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306374-public-summary-positive-opinion-orphan-designation-methoxsalen-treatment-graft-versus-host-disease_en.pdf"},
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    {"id":"25627","name":"Programme - 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-04-25T16:00:00Z","last_updated_date":"2018-06-18T17:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-2018-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
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    {"id":"25636","name":"Final assessment report on Lavandula angustifolia Miller, aetheroleum and Lavandula angustifolia Miller, flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-13T18:00:00Z","last_updated_date":"2012-06-13T18:00:00Z","reference_number":"EMA/HMPC/143183/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-lavandula-angustifolia-miller-aetheroleum-and-lavandula-angustifolia-miller-flos_en.pdf"},
    {"id":"25637","name":"Presentation - COMP update (Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comp-update-daniel-oconnor_en.pdf"},
    {"id":"25640","name":"Update on review of valsartan medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-09-13T02:00:00Z","last_updated_date":"2018-09-13T02:00:00Z","reference_number":"EMA/585263/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines_en.pdf"},
    {"id":"25644","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 11-13 February 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-02-14T01:00:00Z","last_updated_date":"2014-02-14T01:00:00Z","reference_number":"EMA/CVMP/54452/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-11-13-february-2014_en.pdf"},
    {"id":"25645","name":"Public statement on the suspension of the marketing authorisation for Optison (perflutren) in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-07-16T02:00:00Z","last_updated_date":"2008-07-16T02:00:00Z","reference_number":"EMEA/210293/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-suspension-marketing-authorisation-optison-perflutren-european-union_en.pdf"},
    {"id":"25646","name":"Qualification opinion on dopamine transporter imaging as an enrichment biomarker for Parkinson’s disease clinical trials in patients with early Parkinsonian symptoms","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-19T17:00:00Z","last_updated_date":"2018-07-19T17:00:00Z","reference_number":"EMA/CHMP/SAWP/765041/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-dopamine-transporter-imaging-enrichment-biomarker-parkinsons-disease-clinical-trials-patients-early-parkinsonian-symptoms_en.pdf"},
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    {"id":"25650","name":"COMP meeting report on the review of applications for orphan designation: July 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-07-27T13:45:00Z","last_updated_date":"2015-07-27T13:45:00Z","reference_number":"EMA/COMP/426505/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-july-2015_en.pdf"},
    {"id":"25651","name":"Public statement on Lactose prepared using Calf Rennet: Risk assessment in relationship to Bovine Spongiform Encephalopathies (BSE)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-02-27T00:09:21Z","last_updated_date":"2002-02-27T00:09:21Z","reference_number":"EMEA/CPMP/571/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-lactose-prepared-using-calf-rennet-risk-assessment-relationship-bovine-spongiform-encephalopathies-bse_en.pdf"},
    {"id":"25652","name":"Hydroxyethyl starch Article-107i referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-12-01T10:54:00Z","reference_number":"EMA/PRAC/691227/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-timetable-procedure_en.pdf"},
    {"id":"25654","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the March 2011 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-03-10T01:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMA/COMP/134956/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-march-2011-meeting_en.pdf"},
    {"id":"25655","name":"EU/3/14/1401: Public summary of opinion on orphan designation: Riluzole for the treatment of traumatic spinal cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/COMP/744269/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141401-public-summary-opinion-orphan-designation-riluzole-treatment-traumatic-spinal-cord-injury_en.pdf"},
    {"id":"25656","name":"Hydrogen peroxide: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hydrogen-peroxide-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"25660","name":"EU/3/11/875: Public summary of opinion on orphan designation: Metronidazole for the treatment of pouchitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2011-07-12T02:00:00Z","reference_number":"EMA/COMP/247584/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311875-public-summary-opinion-orphan-designation-metronidazole-treatment-pouchitis_en.pdf"},
    {"id":"25661","name":"Concept paper on the need for a guideline on the treatment of premenstrual dysphoric disorder (PMDD)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-02-19T01:00:00Z","last_updated_date":"2009-02-19T01:00:00Z","reference_number":"EMEA/CHMP/EWP/11877/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-treatment-premenstrual-dysphoric-disorder-pmdd_en.pdf"},
    {"id":"25662","name":"Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus (Rev.1)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-09-17T18:35:00Z","last_updated_date":"2015-09-17T18:35:00Z","reference_number":"EMA/CVMP/IWP/205351/2006-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-procedure-be-followed-when-batch-vaccine-finished-product-suspected-be-contaminated-bovine-viral-diarrhoea-virus-rev1_en.pdf"},
    {"id":"25664","name":"Presentation - Workshop on the Use of Statistical Methodologies in the Comparability Assessment of Quality Attributes (H. Park, Samsung Bioepis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-use-statistical-methodologies-comparability-assessment-quality-attributes-h-park-samsung-bioepis_en.pdf"},
    {"id":"25666","name":"Superseded opinion of the HMPC on a community herbal monograph on Cynara scolymus L., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T01:00:00Z","last_updated_date":"2011-12-21T01:00:00Z","reference_number":"EMA/HMPC/749911/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-cynara-scolymus-l-folium_en.pdf"},
    {"id":"25668","name":"CVMP summary of positive opinion for Broadline","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"EMA/CVMP/575422/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-broadline_en.pdf"},
    {"id":"25669","name":"Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 6th annual report (2015)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-21T17:00:00Z","last_updated_date":"2016-03-21T17:00:00Z","reference_number":"EMA/57157/2016","document_url":"https://www.ema.europa.eu/en/documents/report/minor-use-or-minor-species-mumslimited-market-scheme-veterinary-medicinal-products-6th-annual-report-2015_en.pdf"},
    {"id":"25670","name":"Metformin Article-31 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T01:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"EMA/867221/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/metformin-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"25671","name":"European Medicines Agency starts review of Pandemrix","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-08-27T02:00:00Z","last_updated_date":"2010-08-27T02:00:00Z","reference_number":"EMA/543435/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-pandemrix_en.pdf"},
    {"id":"25672","name":"Final assessment report on Commiphora molmol Engler, gummi-resina","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T15:00:00Z","last_updated_date":"2011-12-22T15:00:00Z","reference_number":"EMA/HMPC/96910/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"25674","name":"Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"CPMP/EWP/6235/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-prophylaxis-venous-thromboembolic-risk-non-surgical-patients_en.pdf"},
    {"id":"25675","name":"Draft assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2017-04-12T14:08:00Z","last_updated_date":"2017-04-12T14:08:00Z","reference_number":"EMA/HMPC/750266/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-arctostaphylos-uva-ursi-l-spreng-folium_en.pdf"},
    {"id":"25676","name":"EU/3/15/1486: Public summary of positive opinion for orphan designation of Recombinant human mesencephalic astrocyte-derived neurotrophic factor for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T14:00:00Z","last_updated_date":"2015-05-22T14:00:00Z","reference_number":"EMA/COMP/209499/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151486-public-summary-positive-opinion-orphan-designation-recombinant-human-mesencephalic-astrocyte-derived-neurotrophic-factor-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"25678","name":"Codeine Article-31 referral – Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-05T14:00:00Z","last_updated_date":"2012-11-05T13:00:00Z","reference_number":"EMA/641530/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-review-started_en.pdf"},
    {"id":"25679","name":"EU/3/13/1161: Public summary of opinion on orphan designation: Heterologous human adult liver-derived progenitor cells for the treatment of carbamoyl-phosphate-synthase-1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2013-08-21T14:30:00Z","reference_number":"EMA/COMP/413210/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131161-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-progenitor-cells-treatment-carbamoyl-phosphate-synthase-1-deficiency_en.pdf"},
    {"id":"25680","name":"Public statement on Tikosyn (dofetilide): Voluntary withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-04-28T02:09:21Z","last_updated_date":"2004-04-28T02:09:21Z","reference_number":"EMEA/CPMP/1504/04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-tikosyn-dofetilide-voluntary-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"25771","name":"Withdrawal letter: Fulphila","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-fulphila_en.pdf"},
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    {"id":"25811","name":"Guideline on selection of test materials for genotoxicity testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-01-18T01:00:00Z","last_updated_date":"2010-01-18T01:00:00Z","reference_number":"EMEA/HMPC/67644/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-selection-test-materials-genotoxicity-testing-traditional-herbal-medicinal-productsherbal-medicinal-products_en.pdf"},
    {"id":"25813","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous tumour-infiltrating lymphocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-03-23T15:35:00Z","last_updated_date":"2017-03-23T15:35:00Z","reference_number":"EMA/159269/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-tumour-infiltrating-lymphocytes_en.pdf"},
    {"id":"25815","name":"Cardiovascular - Regulatory perspective - Gonzalo Calvo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/cardiovascular-regulatory-perspective-gonzalo-calvo_en.pdf"},
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    {"id":"25828","name":"EU/3/04/237: Public summary of positive opinion for orphan designation of recombinant human insulin-like growth factor-I/recombinant human insulin-like growth factor binding protein-3 for the treatment of Rabson Mendnhal...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-20T00:00:00Z","last_updated_date":"2011-06-22T01:00:00Z","reference_number":"EMEA/COMP/77791/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304237-public-summary-positive-opinion-orphan-designation-recombinant-human-insulin-growth-factor-irecombinant-human-insulin-growth-factor-binding-protein-3-treatment-rabson-mendnhal_en.pdf"},
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    {"id":"25833","name":"Pfizer withdraws its application to change the marketing authorisation for Viagra 50 mg (sildenafil) from prescription-only to non-prescription","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T00:09:21Z","last_updated_date":"2008-11-20T00:09:21Z","reference_number":"EMEA/619122/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/pfizer-withdraws-its-application-change-marketing-authorisation-viagra-50-mg-sildenafil-prescription-only-non-prescription_en.pdf"},
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    {"id":"25837","name":"EU/3/17/1968: Public summary of opinion on orphan designation: Pyrazolo[1,5-a]pyrimidine, 3-[4-chloro-2-(4-morpholinyl)-5-thiazolyl]-7-(1-ethylpropyl)-2,5-dimethyl-pyrazolo[1,3-a]pyrimidine for the treatment of congenita...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/COMP/840575/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171968-public-summary-opinion-orphan-designation-pyrazolo15-apyrimidine-3-4-chloro-2-4-morpholinyl-5-thiazolyl-7-1-ethylpropyl-25-dimethyl-pyrazolo13-apyrimidine-treatment-congenita_en.pdf"},
    {"id":"25841","name":"Final list of references supporting the assessment of Rubus idaeus L., folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T11:00:00Z","last_updated_date":"2014-03-21T11:00:00Z","reference_number":"EMA/HMPC/44210/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-rubus-idaeus-l-folium_en.pdf"},
    {"id":"25843","name":"EU/3/16/1794: Public summary of opinion on orphan designation: 68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2 for the diagnosis of gastrointestinal stromal tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/745295/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161794-public-summary-opinion-orphan-designation-68ga-dota-pabza-dig-dphe-gln-trp-ala-val-gly-his-nhchch2-chch322-diagnosis-gastrointestinal-stromal-tumours_en.pdf"},
    {"id":"25844","name":"Scientific Advice on Quality Aspects for Biologicals - Jean-Hugues Trouvin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-08T00:09:21Z","last_updated_date":"2007-02-08T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-advice-quality-aspects-biologicals-jean-hugues-trouvin_en.pdf"},
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    {"id":"25851","name":"Turkey - Ministry of Agriculture and Rural Affairs, H. Haluk AŠŸkaroÄŸlu","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/turkey-ministry-agriculture-and-rural-affairs-h-haluk-asykaroaylu_en.pdf"},
    {"id":"25853","name":"CattleMarker IBR Inactivated Article-33(4) referral - Divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-19T02:00:00Z","last_updated_date":"2016-07-19T02:00:00Z","reference_number":"EMEA/V/A/115","document_url":"https://www.ema.europa.eu/en/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-divergent-position_en.pdf"},
    {"id":"25855","name":"European Medicines Agency completes review of protamine-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"EMA/CHMP/717405/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-completes-review-protamine-containing-medicines_en.pdf"},
    {"id":"25856","name":"Lumiracoxib - Article 107 procedures - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-12-14T00:08:21Z","last_updated_date":"2007-12-14T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lumiracoxib-article-107-procedures-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lumiracoxib-article-107-procedures-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lumiracoxib-article-107-procedures-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lumiracoxib-article-107-procedures-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lumiracoxib-article-107-procedures-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lumiracoxib-article-107-procedures-annex-ii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lumiracoxib-article-107-procedures-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lumiracoxib-article-107-procedures-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lumiracoxib-article-107-procedures-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lumiracoxib-article-107-procedures-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lumiracoxib-article-107-procedures-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lumiracoxib-article-107-procedures-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lumiracoxib-article-107-procedures-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lumiracoxib-article-107-procedures-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lumiracoxib-article-107-procedures-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lumiracoxib-article-107-procedures-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lumiracoxib-article-107-procedures-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lumiracoxib-article-107-procedures-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lumiracoxib-article-107-procedures-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lumiracoxib-article-107-procedures-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lumiracoxib-article-107-procedures-annex-ii_sv.pdf"}},
    {"id":"25862","name":"Shedding of viral vectors during clinical gene therapy - Ellen Schenk","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/shedding-viral-vectors-during-clinical-gene-therapy-ellen-schenk_en.pdf"},
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    {"id":"25871","name":"EU/3/14/1370: Public summary of opinion on orphan designation: Siponimod for the treatment of polymyositis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/COMP/660610/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141370-public-summary-opinion-orphan-designation-siponimod-treatment-polymyositis_en.pdf"},
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    {"id":"25874","name":"Oncology - Regulatory perspective - Bertil Jonsson","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/oncology-regulatory-perspective-bertil-jonsson_en.pdf"},
    {"id":"25875","name":"Presentation - Pre-submission phase and guidance for novel products (Fia Westerholm, Nikolaus Kriz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pre-submission-phase-and-guidance-novel-products-fia-westerholm-nikolaus-kriz_en.pdf"},
    {"id":"25876","name":"New treatment for patients with multiple myeloma","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/229074/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-treatment-patients-multiple-myeloma_en.pdf"},
    {"id":"25877","name":"Financial compensation for Member States’ participation in the linguistic checking of product related information: Fixed flat hourly cost for 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T11:30:00Z","last_updated_date":"2011-12-20T11:30:00Z","reference_number":"EMA/MB/880875/2011","document_url":"https://www.ema.europa.eu/en/documents/other/financial-compensation-member-states-participation-linguistic-checking-product-related-information-fixed-flat-hourly-cost-2012_en.pdf"},
    {"id":"25878","name":"EMA takes yet another step in public engagement with its first public hearing","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-05T11:30:00Z","last_updated_date":"2017-10-05T11:30:00Z","reference_number":"EMA/655961/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-takes-yet-another-step-public-engagement-its-first-public-hearing_en.pdf"},
    {"id":"25879","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the December 2008 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-12-12T00:09:21Z","last_updated_date":"2008-12-23T00:09:21Z","reference_number":"EMEA/666785/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-december-2008-meeting_en.pdf"},
    {"id":"25881","name":"Agenda - European Network of Paediatric Research at the European Medicines Agency Coordinating Group meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-06-26T19:00:00Z","last_updated_date":"2013-06-26T19:00:00Z","reference_number":"EMA/150389/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-network-paediatric-research-european-medicines-agency-coordinating-group-meeting_en.pdf"},
    {"id":"25882","name":"Presentation - The evolving natural history of SMA types I and II  (Eugenio Mercuri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evolving-natural-history-sma-types-i-and-ii-eugenio-mercuri_en.pdf"},
    {"id":"25884","name":"Presentation - 7 Summary of sessions and way forward (Frank Pà©tavy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-7-summary-sessions-and-way-forward-frank-pactavy_en.pdf"},
    {"id":"25885","name":"EU/3/07/450: Public summary of positive opinion for orphan designation of 5(S)-(2'-hydroxy ethoxy)-20(S)-camptothecin for the treatment of osteosarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2017-08-14T02:00:00Z","reference_number":"EMEA/COMP/148165/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307450-public-summary-positive-opinion-orphan-designation-5s-2-hydroxy-ethoxy-20s-camptothecin-treatment-osteosarcoma_en.pdf"},
    {"id":"25887","name":"CVMP summary of positive opinion for Sileo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-04-13T17:30:00Z","last_updated_date":"2015-04-13T17:30:00Z","reference_number":"EMA/CVMP/123810/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-sileo_en.pdf"},
    {"id":"25888","name":"Adaptive pathways workshop briefing book: readers’ guidance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-18T16:00:00Z","last_updated_date":"2016-11-18T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/adaptive-pathways-workshop-briefing-book-readers-guidance_en.pdf"},
    {"id":"25889","name":"CVMP monthly report of application procedures, guidelines and related documents: November 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-12-12T10:23:00Z","last_updated_date":"2012-12-12T10:23:00Z","reference_number":"EMA/792274/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-november-2012_en.pdf"},
    {"id":"25890","name":"EMA identifies gaps in industry preparedness for Brexit","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T19:16:00Z","last_updated_date":"2018-07-10T19:16:00Z","reference_number":"EMA/445141/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-identifies-gaps-industry-preparedness-brexit_en.pdf"},
    {"id":"25891","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n27-30 May 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-02T02:09:21Z","last_updated_date":"2008-06-02T02:09:21Z","reference_number":"EMEA/CHMP/278126/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-27-30-may-2008_en.pdf"},
    {"id":"25892","name":"Final list of references supporting the assessment of Leonurus cardiaca L., herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/HMPC/127429/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-leonurus-cardiaca-l-herba_en.pdf"},
    {"id":"25893","name":"Hydroxyethyl starch Article-107i procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-timetable-procedure_en.pdf"},
    {"id":"25894","name":"Final paediatric investigation plan: Expected key elements and requirements for a new DTaP-containing combination vaccine for primary and booster vaccination in infants and toddlers","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T13:30:00Z","last_updated_date":"2015-11-23T13:30:00Z","reference_number":"EMA/82701/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/final-paediatric-investigation-plan-expected-key-elements-and-requirements-new-dtap-containing-combination-vaccine-primary-and-booster-vaccination-infants-and-toddlers_en.pdf"},
    {"id":"25897","name":"Presentation - Some current United States Food and Drug Administration thinking on adaptive design clinical trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-some-current-united-states-food-and-drug-administration-thinking-adaptive-design-clinical-trials_en.pdf"},
    {"id":"25902","name":"Working party on Herbal Medicinal Products: points to consider on the biopharmaceutical characterisation of Herbal Medicinal Products","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2003-07-09T02:00:00Z","last_updated_date":"2003-07-09T02:00:00Z","reference_number":"EMEA/HMPWP/344/03","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-points-consider-biopharmaceutical-characterisation-herbal-medicinal-products_en.pdf"},
    {"id":"25903","name":"European Medicines Agency recommends suspension of marketing authorisations for meprobamate-containing medicines in the European Union","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-01-20T14:00:00Z","last_updated_date":"2012-01-20T14:00:00Z","reference_number":"EMA/CHMP/49123/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-marketing-authorisations-meprobamate-containing-medicines-european-union_en.pdf"},
    {"id":"25906","name":"Scientific recommendation on classification of advanced therapy medicinal products: Irradiated plasmacytoid dendritic cell line loaded with peptides from tumour antigens","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T19:00:00Z","last_updated_date":"2015-08-26T19:00:00Z","reference_number":"EMA/556392/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-irradiated-plasmacytoid-dendritic-cell-line-loaded-peptides-tumour-antigens_en.pdf"},
    {"id":"25907","name":"EU/3/04/210: Public summary of positive opinion for orphan designation of ciclosporin for the treatment of bronchiolitis obliterans syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-13T00:00:00Z","last_updated_date":"2018-10-12T11:10:00Z","reference_number":"EMEA/COMP/293/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304210-public-summary-positive-opinion-orphan-designation-ciclosporin-treatment-bronchiolitis-obliterans-syndrome_en.pdf"},
    {"id":"25908","name":"Aloe vera gel: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/650/99","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/aloe-vera-gel-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"25909","name":"Final list of references supporting the assessment of Salvia officinalis L., folium and Salvia officinalis L., aetheroleum - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2017-07-13T02:00:00Z","last_updated_date":"2017-07-13T02:00:00Z","reference_number":"MA/HMPC/277151/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-salvia-officinalis-l-folium-and-salvia-officinalis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"25911","name":"Benzathine benzylpenicillin Article-35 referral - Annex I, II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2014-08-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/benzathine-benzylpenicillin-article-35-referral-annex-i-ii_sv.pdf"}},
    {"id":"25912","name":"NIHR Medicines for Children Research Network - Prof David Edwards","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/nihr-medicines-children-research-network-prof-david-edwards_en.pdf"},
    {"id":"25913","name":"Tumour selectively replicating oncolytic adenovirus expressing tumour necrosis factor alpha (TNFα) and interleukin 2 (IL2)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T16:33:00Z","last_updated_date":"2016-11-15T16:33:00Z","reference_number":"EMA/693934/2016","document_url":"https://www.ema.europa.eu/en/documents/report/tumour-selectively-replicating-oncolytic-adenovirus-expressing-tumour-necrosis-factor-alpha-tnfi-and-interleukin-2-il2_en.pdf"},
    {"id":"25915","name":"EU/3/17/1946: Public summary of opinion on orphan designation:  (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidine-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridine-2-yl)-4-fluoropyrrolidine-2-carboxamide for the treatment of p...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-24T10:44:00Z","last_updated_date":"2018-01-24T10:44:00Z","reference_number":"EMA/753055/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171946-public-summary-opinion-orphan-designation-2s4r-1-2-3-acetyl-5-2-methylpyrimidine-5-yl-1h-indazol-1-ylacetyl-n-6-bromopyridine-2-yl-4-fluoropyrrolidine-2-carboxamide-treatment-p_en.pdf"},
    {"id":"25916","name":"EU/3/09/720: Public summary of opinion on orphan designation of lentiviral vector containing the human ABCA4 gene for the treatment of Stargardt’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMA/COMP/814184/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309720-public-summary-opinion-orphan-designation-lentiviral-vector-containing-human-abca4-gene-treatment-stargardts-disease_en.pdf"},
    {"id":"25917","name":"Ketoconazole Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T02:00:00Z","last_updated_date":"2014-06-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoconazole-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ketoconazole-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ketoconazole-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ketoconazole-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ketoconazole-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ketoconazole-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ketoconazole-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ketoconazole-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ketoconazole-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ketoconazole-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ketoconazole-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ketoconazole-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ketoconazole-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ketoconazole-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ketoconazole-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ketoconazole-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ketoconazole-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ketoconazole-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ketoconazole-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ketoconazole-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ketoconazole-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ketoconazole-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ketoconazole-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/ketoconazole-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/ketoconazole-article-31-referral-annex-i_no.pdf"}},
    {"id":"25918","name":"Committee for Proprietary Medicinal Products (CPMP) 51st plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-07-30T02:00:00Z","last_updated_date":"1999-07-30T02:00:00Z","reference_number":"CPMP/2137/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-51st-plenary-meeting_en.pdf"},
    {"id":"25921","name":"CHMP ORGAM agenda for the meeting on 22 May 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-06-06T13:59:00Z","last_updated_date":"2018-06-06T13:59:00Z","reference_number":"EMA/CHMP/324079/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-22-may-2018_en.pdf"},
    {"id":"25923","name":"Substances related to nicotinic acid Article-31 referral - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-13T18:00:00Z","last_updated_date":"2014-03-13T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-cmdh-divergent-position_en.pdf"},
    {"id":"25924","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 20-24 April 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-04-22T02:09:21Z","last_updated_date":"2004-04-22T02:09:21Z","reference_number":"EMEA/D/11206/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-20-24-april-2004_en.pdf"},
    {"id":"25925","name":"VICH GL47: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studies","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-04-07T02:00:00Z","last_updated_date":"2011-04-07T02:00:00Z","reference_number":"EMA/CVMP/VICH/463104/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl47-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-animals-laboratory-animal-comparative-metabolism-studies_en.pdf"},
    {"id":"25926","name":"Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-09T18:00:00Z","last_updated_date":"2016-11-09T18:00:00Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-hydrochloride-chlordiazepoxide-list-nationally-authorised-medicinal-products-psusa00000171201602_en.pdf"},
    {"id":"25927","name":"Withdrawal letter: Graspa","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-graspa_en.pdf"},
    {"id":"25928","name":"CHMP post-authorisation summary of positive opinion for Avastin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-02-19T00:09:21Z","last_updated_date":"2009-02-19T00:09:21Z","reference_number":"EMEA/CHMP/121120/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-avastin_en.pdf-4"},
    {"id":"25930","name":"Guideline on summary of requirements for active substances in the quality part of the dossier - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"CHMP/QWP/297/97 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-summary-requirements-active-substances-quality-part-dossier-revision-1_en.pdf"},
    {"id":"25931","name":"European Medicines Agency’s Management Board endorses work programme 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-12-16T15:00:00Z","last_updated_date":"2012-01-10T15:45:00Z","reference_number":"EMA/MB/975513/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-endorses-work-programme-2012_en.pdf"},
    {"id":"25932","name":"Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-05T11:30:00Z","last_updated_date":"2018-04-12T02:00:00Z","reference_number":"EMA/93253/2014","document_url":"https://www.ema.europa.eu/en/documents/other/cover-note-extended-eudravigilance-medicinal-product-dictionary-xevmpd-substance-controlled-vocabulary-following-quality-control-exercise_en.pdf"},
    {"id":"25935","name":"Butafosfan (all mammalian food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T17:30:00Z","last_updated_date":"2014-02-20T17:30:00Z","reference_number":"EMA/CVMP/335153/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/butafosfan-all-mammalian-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"25936","name":"EU/3/06/424: Public summary of positive opinion for orphan designation of thiotepa for the conditioning treatment prior to haematopoietic progenitor cell transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2014-01-22T01:00:00Z","reference_number":"EMA/COMP/504488/2006 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306424-public-summary-positive-opinion-orphan-designation-thiotepa-conditioning-treatment-prior-haematopoietic-progenitor-cell-transplantation_en.pdf"},
    {"id":"25939","name":"Presentation - Patient involvement at Food and Drug Administration (FDA) (Andrea Furia-Helms)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-10T18:30:00Z","last_updated_date":"2015-08-10T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-involvement-food-and-drug-administration-fda-andrea-furia-helms_en.pdf"},
    {"id":"25941","name":"Presentation - PML development, Heinz Wiendl","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pml-development-heinz-wiendl_en.pdf"},
    {"id":"25942","name":"Superseded opinion of the HMPC on a Community herbal monograph on Rhamnus frangula L., cortex - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-09-07T02:00:00Z","last_updated_date":"2006-09-07T02:00:00Z","reference_number":"EMEA/HMPC/429405/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-rhamnus-frangula-l-cortex-first-version_en.pdf"},
    {"id":"25943","name":"Agenda and registration form for: 2nd DIA/EMA Innovation Forum: Is the EU regulatory framework ready?","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-10-26T02:00:00Z","last_updated_date":"2010-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-2nd-diaema-innovation-forum-eu-regulatory-framework-ready_en.pdf"},
    {"id":"25945","name":"HPV vaccines - Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-13T02:00:00Z","last_updated_date":"2015-09-24T02:00:00Z","reference_number":"EMA/PRAC/454661/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/hpv-vaccines-article-20-procedure-timetable-procedure_en.pdf"},
    {"id":"25946","name":"EU/3/10/838: Public summary of opinion on orphan designation: Plitidepsin for the treatment of post-essential thrombocythaemia myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-07T01:00:00Z","last_updated_date":"2011-09-06T02:00:00Z","reference_number":"EMA/COMP/740407/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310838-public-summary-opinion-orphan-designation-plitidepsin-treatment-post-essential-thrombocythaemia-myelofibrosis_en.pdf"},
    {"id":"25948","name":"Presentation - Translating benefit-risk information into product information (Laurent Brassart)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-translating-benefit-risk-information-product-information-laurent-brassart_en.pdf"},
    {"id":"25950","name":"Esketamine : List of nationally authorised medicinal products -  PSUSA/00001266/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-15T12:19:00Z","last_updated_date":"2017-05-15T12:21:00Z","reference_number":"EMA/303127/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/esketamine-list-nationally-authorised-medicinal-products-psusa00001266201608_en.pdf"},
    {"id":"25951","name":"Presentation - Dealing with risk and uncertainties (A. Nordmark, N. Benda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dealing-risk-and-uncertainties-nordmark-n-benda_en.pdf"},
    {"id":"25952","name":"Guidance on applications for potential high risk medicinal product trials - Brian Davis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/guidance-applications-potential-high-risk-medicinal-product-trials-brian-davis_en.pdf"},
    {"id":"25956","name":"ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population - Revision 1 (addendum)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-06T19:00:00Z","last_updated_date":"2017-10-06T19:00:00Z","reference_number":"EMA/CPMP/ICH/2711/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population-revision-1-addendum_en.pdf"},
    {"id":"25958","name":"Committee for Proprietary Medicinal Products (CPMP) 40th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-07-27T02:00:00Z","last_updated_date":"1998-07-27T02:00:00Z","reference_number":"CPMP/1342/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-40th-plenary-meeting_en.pdf"},
    {"id":"25959","name":"Withdrawal letter : NutropinAq","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T01:00:00Z","last_updated_date":"2008-01-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-nutropinaq_en.pdf"},
    {"id":"25960","name":"Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T19:18:14Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/813938/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pdf"},
    {"id":"25962","name":"CHMP summary of positive opinion for Mvasi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2017-11-10T01:00:00Z","reference_number":"EMA/708111/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mvasi_en.pdf"},
    {"id":"25963","name":"Scientific recommendation on classification of advanced therapy medicinal products: Wharton jelly derived allogeneic mesenchymal stem cells, cultured in vitro","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-28T13:00:00Z","last_updated_date":"2016-11-28T13:00:00Z","reference_number":"EMA/758391/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-wharton-jelly-derived-allogeneic-mesenchymal-stem-cells-cultured-vitro_en.pdf"},
    {"id":"25964","name":"EMEA implementation of electronic-only submissions and mandatory eCTD submissions in the centralised procedure: Statement of intent relating to non-eCTD submissions","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-12-01T01:00:00Z","last_updated_date":"2008-12-01T01:00:00Z","reference_number":"EMEA/577842/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/emea-implementation-electronic-only-submissions-and-mandatory-ectd-submissions-centralised-procedure-statement-intent-relating-non-ectd-submissions_en.pdf"},
    {"id":"25966","name":"Presentation - Possible scenarios to address issues in non-clinical studies for advanced-therapy medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T12:00:00Z","last_updated_date":"2012-02-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-possible-scenarios-address-issues-non-clinical-studies-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"25967","name":"Presentation - PENTA-ID and Pharma collaborations Enpr-EMA 2013 (M. Sharland)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-penta-id-and-pharma-collaborations-enpr-ema-2013-m-sharland_en.pdf"},
    {"id":"25968","name":"CHMP post-authorisation summary of positive opinion for Dexdor","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"EMA/CHMP/430649/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dexdor_en.pdf"},
    {"id":"25972","name":"Cinnamomi cassiae cortex: Summary report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-05-10T02:00:00Z","last_updated_date":"2012-05-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cinnamomi-cassiae-cortex-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"25973","name":"Presentation - United Kingdom's withdrawal from the European Union preparedness activities - Q&A session on PhV Brexit related topic (M. Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T15:08:00Z","last_updated_date":"2018-01-04T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-united-kingdoms-withdrawal-european-union-preparedness-activities-qa-session-phv-brexit-related-topic-m-pinheiro_en.pdf"},
    {"id":"25975","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 A: Clinical safety data management: Definitions and standards for expedited reporting - Step...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1995-06-01T02:00:00Z","last_updated_date":"1995-06-01T02:00:00Z","reference_number":"CPMP/ICH/377/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-topic-e-2-clinical-safety-data-management-definitions-and-standards-expedited-reporting-step_en.pdf"},
    {"id":"25978","name":"Presentation - The risk-based approach for ATMP (Egbert Flory)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-12T19:00:00Z","last_updated_date":"2015-05-12T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-based-approach-atmp-egbert-flory_en.pdf"},
    {"id":"25979","name":"Minutes - Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T18:30:00Z","last_updated_date":"2017-05-16T18:30:00Z","reference_number":"EMA/80558/20177","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-tenth-industry-stakeholder-platform-operation-pharmacovigilance-european-union_en.pdf"},
    {"id":"25980","name":"Standard Operating Procedure for Reports of Defective Centrally Authorised Products","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-02-09T01:00:00Z","last_updated_date":"2007-02-09T01:00:00Z","reference_number":"EMEA/INS/GMP/75465/2007","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-reports-defective-centrally-authorised-products_en.pdf"},
    {"id":"25981","name":"Committee for medicinal products for veterinary use summary of opinion: Duvaxyn WNV: International Non-proprietary Name (INN): Vaccine to aid in prevention of West Nile virus","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-09-19T03:09:21Z","last_updated_date":"2008-09-19T03:09:21Z","reference_number":"EMEA/CVMP/425966/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-duvaxyn-wnv-international-non-proprietary-name-inn-vaccine-aid-prevention-west-nile-virus_en.pdf"},
    {"id":"25985","name":"29th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-02-12T12:39:21Z","last_updated_date":"1998-02-12T12:39:21Z","reference_number":"EMEA/CVMP/069/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/29th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"25986","name":"Dienogest / Ethinylestradiol Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/144143/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/dienogest-ethinylestradiol-article-31-referral-review-started_en.pdf"},
    {"id":"25987","name":"Pre-Qualification Questionnaire (PQQ) for a restricted tender procedure organised by European Medicines Agency (EMEA) electronic databases (Lots 1-11) EMEA/2008/60/DM&P","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure-organised-european-medicines-agency-emea-electronic-databases-lots-1-11-emea200860dmp_en.doc"},
    {"id":"25988","name":"EU/3/12/1039: Public summary of opinion on orphan designation: Recombinant anti-CD3-bi-single-chain-Fv-diphtheria toxin fusion protein for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-27T16:00:00Z","last_updated_date":"2012-09-27T16:00:00Z","reference_number":"EMA/COMP/509614/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121039-public-summary-opinion-orphan-designation-recombinant-anti-cd3-bi-single-chain-fv-diphtheria-toxin-fusion-protein-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"25989","name":"EU/3/13/1150: Public summary of opinion on orphan designation: Moxetumomab pasudotox for the treatment of B-lymphoblastic leukaemia / lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T17:30:00Z","last_updated_date":"2022-07-25T12:38:00Z","reference_number":"EMA/COMP/413548/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131150-public-summary-opinion-orphan-designation-moxetumomab-pasudotox-treatment-b-lymphoblastic-leukaemia-lymphoma_en.pdf"},
    {"id":"25990","name":"Regulatory Cooperation Expanded","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-18T02:00:00Z","last_updated_date":"2007-06-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/regulatory-cooperation-expanded_en.pdf"},
    {"id":"25997","name":"Concept paper on haematological malignancies","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T00:09:21Z","last_updated_date":"2008-01-24T00:09:21Z","reference_number":"EMEA/CHMP/EWP/20808/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-haematological-malignancies_en.pdf"},
    {"id":"25998","name":"Questions and answers on Article 31 non-pharmacovigilance referrals","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-07-06T18:00:00Z","last_updated_date":"2018-09-21T16:00:00Z","reference_number":"EMA/457344/2016 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-article-31-non-pharmacovigilance-referrals_en.pdf"},
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    {"id":"26002","name":"Presentation - Lessons learnt by EU regulators from the authorisations of foot-and-mouth disease, avian influenza, bluetongue and schmallenberg vaccines in the EU (Esther Werner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-14T17:20:00Z","last_updated_date":"2017-06-14T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lessons-learnt-eu-regulators-authorisations-foot-and-mouth-disease-avian-influenza-bluetongue-and-schmallenberg-vaccines-eu-esther-werner_en.pdf"},
    {"id":"26004","name":"Presentation - COMP update June 2015 (Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-10T18:30:00Z","last_updated_date":"2015-08-10T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comp-update-june-2015-daniel-oconnor_en.pdf"},
    {"id":"26006","name":"Presentation - Innovation task force (ITF), Dr. Marisa Papaluca Amati","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-innovation-task-force-itf-dr-marisa-papaluca-amati_en.pdf"},
    {"id":"26007","name":"Call for expressions of interest, from terminology maintenance organisations, software vendors, service providers and developers of medicinal product dictionaries/databases, for membership in a Task Force for the impleme...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-20T12:00:00Z","last_updated_date":"2015-02-20T12:00:00Z","reference_number":"EMA/60018/2015","document_url":"https://www.ema.europa.eu/en/documents/other/call-expressions-interest-terminology-maintenance-organisations-software-vendors-service-providers-and-developers-medicinal-product-dictionariesdatabases-membership-task-force-impleme_en.pdf"},
    {"id":"26009","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Calcichew-D3 and associated names International Non-Proprietary Name (INN): Calcium 500mg / choleca...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-12-01T00:08:21Z","last_updated_date":"2003-12-01T00:08:21Z","reference_number":"EMEA/CPMP/3257/03/en/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-calcichew-d3-and-associated-names-international-non-proprietary-name-inn-calcium-500mg-choleca_en.pdf"},
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    {"id":"26015","name":"Committee for veterinary medicinal products: guidelines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-08-15T14:09:21Z","last_updated_date":"2001-08-15T14:09:21Z","reference_number":"EMEA/CVMP/732/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-guidelines_en.pdf"},
    {"id":"26019","name":"Overview of comments received on the draft 'Information in the package leaflet for fructose and sorbitol'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/581887/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-information-package-leaflet-fructose-and-sorbitol_en.pdf"},
    {"id":"26020","name":"EU/3/14/1343: Public summary of opinion on orphan designation: Immunoglobulin G1, anti-(human tumour-associated calcium signal transducer 2)(human-Mus musculus monoclonal hRS7 heavy chain), disulfide with human-Mus muscu...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/552859/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141343-public-summary-opinion-orphan-designation-immunoglobulin-g1-anti-human-tumour-associated-calcium-signal-transducer-2human-mus-musculus-monoclonal-hrs7-heavy-chain-disulfide-human-mus-muscu_en.pdf"},
    {"id":"26021","name":"EU/3/08/571: Public summary of positive opinion for orphan designation of recombinant human minibody against complement component C5 for the treatment of atypical haemolytic uraemic syndrome (aHUS) associated with an inh...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2014-01-22T01:00:00Z","reference_number":"EMA/COMP/363566/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308571-public-summary-positive-opinion-orphan-designation-recombinant-human-minibody-against-complement-component-c5-treatment-atypical-haemolytic-uraemic-syndrome-ahus-associated-inh_en.pdf"},
    {"id":"26022","name":"Final European Union herbal monograph on Vaccinium myrtillus L., fructus recens","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"EMA/HMPC/375808/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-vaccinium-myrtillus-l-fructus-recens_en.pdf"},
    {"id":"26024","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iii_en.pdf"},
    {"id":"26026","name":"Start of community reviews: CHMP meeting of 20-23 June 2016","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T14:00:00Z","last_updated_date":"2016-06-24T14:00:00Z","reference_number":"EMA/427430/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-20-23-june-2016_en.pdf"},
    {"id":"26027","name":"Presentation - Gadolinium-containing magnetic resonance contrast agents and communication practices in European Union Member States","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T01:00:00Z","last_updated_date":"2011-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gadolinium-containing-magnetic-resonance-contrast-agents-and-communication-practices-european-union-member-states_en.pdf"},
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    {"id":"26033","name":"Committee for Medicinal products for Human use positive summary of opinion for Docefrez","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-02-19T01:00:00Z","last_updated_date":"2012-06-14T02:00:00Z","reference_number":"EMA/CHMP/54045/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-positive-summary-opinion-docefrez_en.pdf"},
    {"id":"26035","name":"IMI strategic research agenda as it applies to surrogates - Lindpaintner","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/imi-strategic-research-agenda-it-applies-surrogates-lindpaintner_en.pdf"},
    {"id":"26036","name":"Presentation - Case study 3 - Use of prior knowledge in the control strategy for biotechnology products - Session 4 (Darrin Cowley, Jette Wypych)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-3-use-prior-knowledge-control-strategy-biotechnology-products-session-4-darrin-cowley-jette-wypych_en.pdf"},
    {"id":"26039","name":"Opinion of the CVMP on the establishment of maximum residue limits: Fenbendazole","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-01-22T10:10:00Z","last_updated_date":"2013-01-22T10:10:00Z","reference_number":"EMA/CVMP/845730/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-fenbendazole_en.pdf"},
    {"id":"26040","name":"Presentation - Framework of EMA interaction with patients’ and consumers’ organisations (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-framework-ema-interaction-patients-and-consumers-organisations-isabelle-moulon_en.pdf"},
    {"id":"26041","name":"ICH: Q 4 B Annex 4C: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on  microbiological examination of non-sterile products: Acceptance criteria for pharmaceutical preparatio...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2008-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/308867/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-4c-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-microbiological-examination-non-sterile-products-acceptance-criteria-pharmaceutical-preparatio_en.pdf"},
    {"id":"26043","name":"EU/3/17/1886: Public summary of opinion on orphan designation: Sirolimus for the treatment of tuberous sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/329992/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171886-public-summary-opinion-orphan-designation-sirolimus-treatment-tuberous-sclerosis_en.pdf"},
    {"id":"26044","name":"N(2)-L-alanyl-L-glutamine: List of nationally authorised medicinal products - PSUSA/00003158/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-09T12:20:00Z","last_updated_date":"2016-12-09T12:20:00Z","reference_number":"EMA/847829/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/n2-l-alanyl-l-glutamine-list-nationally-authorised-medicinal-products-psusa00003158201603_en.pdf"},
    {"id":"26045","name":"Withdrawal assessment report for Emerflu","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-emerflu_en.pdf"},
    {"id":"26046","name":"EU/3/14/1351: Public summary of opinion on orphan designation: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 for the treatment of X-linked hypophosphataemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/551233/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141351-public-summary-opinion-orphan-designation-recombinant-human-monoclonal-igg1-antibody-fibroblast-growth-factor-23-treatment-x-linked-hypophosphataemia_en.pdf"},
    {"id":"26047","name":"Cobalt carbonate, cobalt dichloride, cobalt gluconate, cobalt oxide, cobalt sulphate and cobalt trioxide: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/387/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cobalt-carbonate-cobalt-dichloride-cobalt-gluconate-cobalt-oxide-cobalt-sulphate-and-cobalt-trioxide-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"26120","name":"Antithrombin iii : List of nationally authorised medicinal products - PSUSA/00003159/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T17:17:00Z","last_updated_date":"2017-09-06T17:19:42Z","reference_number":"EMA/562354/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/antithrombin-iii-list-nationally-authorised-medicinal-products-psusa00003159201612_en.pdf"},
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    {"id":"26123","name":"Draft list of references supporting the assessment of Aesculus hippocastanum L., cortex","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-10-26T12:30:03Z","last_updated_date":"2011-10-26T12:30:03Z","reference_number":"EMA/HMPC/354158/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-aesculus-hippocastanum-l-cortex_en.pdf"},
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    {"id":"26246","name":"Outcome of public consultation on 'Questions and answers on implementation of risk-based prevention of cross contamination in production 'and ‘Guideline on setting health based exposure limits for use in risk identificat...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-08-02T16:00:00Z","last_updated_date":"2018-08-02T16:00:00Z","reference_number":"EMA/288493/2018","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-public-consultation-questions-and-answers-implementation-risk-based-prevention-cross-contamination-production-and-guideline-setting-health-based-exposure-limits-use-risk-identificat_en.pdf"},
    {"id":"26248","name":"Boldo folium: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/548/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/boldo-folium-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"26252","name":"EU/3/18/1988: Public summary of opinion on orphan designation: (R)-2-(5-cyano-2-(6-(methoxycarbonyl)-7-methyl-3-oxo-8-(3-(trifluoromethyl)phenyl)-2,3,5,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrimidine-5-yl)phenyl)-N,N,N-tri...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/60696/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181988-public-summary-opinion-orphan-designation-r-2-5-cyano-2-6-methoxycarbonyl-7-methyl-3-oxo-8-3-trifluoromethylphenyl-2358-tetrahydro-124triazolo43-apyrimidine-5-ylphenyl-nnn-tri_en.pdf"},
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    {"id":"26257","name":"Factor VIII Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/PRAC/471535/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-prac-list-questions_en.pdf"},
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    {"id":"26265","name":"Presentation - European Group for Generic Veterinary Products (EGGVP): Concerns on data collection from MAHs (Elsa Vecino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-group-generic-veterinary-products-eggvp-concerns-data-collection-mahs-elsa-vecino_en.pdf"},
    {"id":"26266","name":"Procedure for handling rapid alerts arising from quality defects","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/INS/GMP/313510/2006 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-handling-rapid-alerts-arising-quality-defects_en.pdf"},
    {"id":"26268","name":"Opinion of the Committee on Herbal Medicinal Products on a Community herbal monograph on Arctium lappa L., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-04-14T02:00:00Z","last_updated_date":"2011-04-14T02:00:00Z","reference_number":"EMA/HMPC/573551/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-arctium-lappa-l-radix_en.pdf"},
    {"id":"26270","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 11 – 14 December 2017","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/CHMP/SAWP/833040/2017","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-11-14-december-2017_en.pdf"},
    {"id":"26271","name":"Initial notices for parallel distribution – January 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-07-10T15:20:00Z","last_updated_date":"2014-07-10T15:20:00Z","reference_number":"EMA/70960/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-january-2014_en.pdf"},
    {"id":"26274","name":"European Medicines Agency mid-year report 2016 from the Executive Director","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-14T11:53:00Z","last_updated_date":"2017-02-14T11:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-mid-year-report-2016-executive-director_en.pdf"},
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    {"id":"26276","name":"VICH GL35: Pharmacovigilance: electronic standards for transfer of data","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-03-13T16:30:00Z","last_updated_date":"2023-05-22T10:43:00Z","reference_number":"EMA/CVMP/VICH/123940/2006 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl35-pharmacovigilance-electronic-standards-transfer-data_en.pdf"},
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    {"id":"26407","name":"Decision on amending budget No 1-2017","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-06T17:00:00Z","last_updated_date":"2017-10-06T17:00:00Z","reference_number":"EMA/MB/163175/2017","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-1-2017_en.pdf"},
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    {"id":"26412","name":"Presentation - Case study 1- Use of prior knowledge to support specification setting for a multivalent vaccine - Session 4 (Charles Kline)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-1-use-prior-knowledge-support-specification-setting-multivalent-vaccine-session-4-charles-kline_en.pdf"},
    {"id":"26413","name":"EU Medicines Agencies Network Strategy to 2020 : Comments received from public consultation - List of stakeholders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/464136/2015","document_url":"https://www.ema.europa.eu/en/documents/other/eu-medicines-agencies-network-strategy-2020-comments-received-public-consultation-list-stakeholders_en.pdf"},
    {"id":"26414","name":"Questions and answers on withdrawal of the application for a change to the marketing authorisation for Exelon and Prometax (rivastigmine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-04-19T02:00:00Z","last_updated_date":"2012-05-21T02:00:00Z","reference_number":"EMA/226251/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-exelon-and-prometax-rivastigmine_sv.pdf"}},
    {"id":"26419","name":"Presentation - Operational definition of medication error for European Union reporting requirements (Thomas Goedecke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-operational-definition-medication-error-european-union-reporting-requirements-thomas-goedecke_en.pdf"},
    {"id":"26422","name":"EU/3/02/086: Public summary of positive opinion for orphan designation of porfimer sodium (for use with photodynamic therapy) for the treatment of high-grade dysplasia in Barrett’s oesophagus","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:00:00Z","last_updated_date":"2013-06-20T13:00:00Z","reference_number":"EMEA/COMP/69/02 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302086-public-summary-positive-opinion-orphan-designation-porfimer-sodium-use-photodynamic-therapy-treatment-high-grade-dysplasia-barretts-oesophagus_en.pdf"},
    {"id":"26424","name":"Overview of comments received on Paliperidone palmitate depot suspension for injection 25 mg, 50 mg, 75 mg, 100 mg and 150 mg product-specific bioequivalence guidance (EMA/CHMP/474825/2016)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-03-03T01:00:00Z","last_updated_date":"2017-03-03T01:00:00Z","reference_number":"EMA/CHMP/810545/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-paliperidone-palmitate-depot-suspension-injection-25-mg-50-mg-75-mg-100-mg-and-150-mg-product-specific-bioequivalence-guidance-emachmp4748252016_en.pdf"},
    {"id":"26426","name":"Final list of references supporting the assessment of Taraxacum officinale Weber ex Wigg., folium","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/HMPC/579635/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-taraxacum-officinale-weber-ex-wigg-folium_en.pdf"},
    {"id":"26428","name":"Public statement on Vitrasert Implant (ganciclovir): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-05-13T02:00:00Z","last_updated_date":"2002-05-13T02:00:00Z","reference_number":"EMEA/7211/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-vitrasert-implant-ganciclovir-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"26430","name":"Presentation - Equivalence vs. non-inferiority: Regulator‘s view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:55Z","last_updated_date":"2012-06-15T17:10:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-equivalence-vs-non-inferiority-regulators-view_en.pdf"},
    {"id":"26431","name":"Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, 25 October 2017","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-12-18T13:40:00Z","last_updated_date":"2017-12-18T13:40:00Z","reference_number":"EMA/642660/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting-25-october-2017_en.pdf"},
    {"id":"26433","name":"Twenty-First Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-02-10T01:00:00Z","last_updated_date":"1999-02-10T01:00:00Z","reference_number":"EMEA/MB/015/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/twenty-first-meeting-management-board_en.pdf"},
    {"id":"26435","name":"Presentation - Regulatory perspective (Mario Miguel Rosa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-perspective-mario-miguel-rosa_en.pdf"},
    {"id":"26438","name":"Presentation - Holistic approach to paediatric research: European society for paediatric research (K. Allegaert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:04:00Z","last_updated_date":"2018-06-18T12:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-european-society-paediatric-research-k-allegaert_en.pdf"},
    {"id":"26439","name":"Final community herbal monograph on Avena sativa L., fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/368600/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-avena-sativa-l-fructus_en.pdf"},
    {"id":"26441","name":"CHMP summary of positive opinion for Capecitabine SUN","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2016-12-22T01:00:00Z","reference_number":"EMA/CHMP/138360/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-capecitabine-sun_en.pdf"},
    {"id":"26442","name":"Dienogest / Ethinylestradiol Article-31 referral - CHMP list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/CHMP/147245/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/dienogest-ethinylestradiol-article-31-referral-chmp-list-questions_en.pdf"},
    {"id":"26444","name":"EU/3/17/1967: Public summary of opinion on orphan designation: N-[2,6-bis(1-methylethyl)phenyl]-N'-[[1-[4-\n\n(dimethylamino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt for the\n\ntreatment of congenital adrenal hyper...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-13T01:00:00Z","last_updated_date":"2018-03-13T01:00:00Z","reference_number":"EMA/848721/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171967-public-summary-opinion-orphan-designation-n-26-bis1-methylethylphenyl-n-1-4-dimethylaminophenylcyclopentylmethylurea-hydrochloride-salt-treatment-congenital-adrenal-hyper_en.pdf"},
    {"id":"26445","name":"Note for guidance: Approach towards harmonisation of withdrawal periods","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1996-04-01T02:00:00Z","last_updated_date":"1996-04-01T02:00:00Z","reference_number":"EMEA/CVMP/036/95 - FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-approach-towards-harmonisation-withdrawal-periods_en.pdf"},
    {"id":"26448","name":"Results of the sampling and testing programme for the year 2013","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-08-17T16:30:00Z","last_updated_date":"2015-08-17T16:30:00Z","reference_number":"EMA/INS/S&T/517529/2014","document_url":"https://www.ema.europa.eu/en/documents/report/results-sampling-and-testing-programme-year-2013_en.pdf"},
    {"id":"26450","name":"Presentation - Paediatric Pulmonary Arterial Hypertension: Regulators perspective on a global challenge (Cà©cile Ollivier, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-pulmonary-arterial-hypertension-regulators-perspective-global-challenge-caccile-ollivier-ema_en.pdf"},
    {"id":"26451","name":"Committee for Medicinal Products for Human Use (CHMP) - June 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-06-29T02:00:00Z","last_updated_date":"2007-06-29T02:00:00Z","reference_number":"EMEA/267656/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-june-2007-plenary-meeting-monthly-report_en.pdf"},
    {"id":"26453","name":"Agenda - Programme - European Medicines Agency workshop: Ensuring safe and effective medicines for an ageing population","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-02-07T17:45:00Z","last_updated_date":"2012-03-21T13:32:00Z","reference_number":"EMA/966612/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-european-medicines-agency-workshop-ensuring-safe-and-effective-medicines-ageing-population_en.pdf"},
    {"id":"26457","name":"CHMP summary of positive opinion for Xultophy","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/424921/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xultophy_en.pdf"},
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    {"id":"26459","name":"National-competent-authority and European Medicines Agency requirements for submission of periodic safety update reports during the transitional period","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-05-23T20:04:25Z","last_updated_date":"2014-08-08T13:30:00Z","reference_number":"EMA/413951/2012 Rev. 8","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/national-competent-authority-and-european-medicines-agency-requirements-submission-periodic-safety-update-reports-during-transitional-period_en.pdf"},
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    {"id":"26470","name":"EU/3/13/1148: Public summary of opinion on orphan designation: Autologous bone-marrow-derived mesenchymal stromal cells secreting neurotrophic factors for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-16T02:00:00Z","last_updated_date":"2013-08-16T02:00:00Z","reference_number":"EMA/COMP/417227/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131148-public-summary-opinion-orphan-designation-autologous-bone-marrow-derived-mesenchymal-stromal-cells-secreting-neurotrophic-factors-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
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    {"id":"26491","name":"EU/3/15/1587: Public summary of opinion on orphan designation: Combretastatin A1 diphosphate for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/COMP/791083/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151587-public-summary-opinion-orphan-designation-combretastatin-a1-diphosphate-treatment-acute-myeloid-leukaemia_en.pdf"},
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    {"id":"26494","name":"Demeclocycline / triamcinolone: List of nationally authorised medicinal products - PSUSA/00010415/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-22T17:00:00Z","last_updated_date":"2018-03-22T17:00:00Z","reference_number":"EMA/182799/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/demeclocycline-triamcinolone-list-nationally-authorised-medicinal-products-psusa00010415201707_en.pdf"},
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    {"id":"26513","name":"Submission of comments template - EU Medicines Agencies Network Strategy to 2020 - Working together to improve health","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-03-31T12:00:00Z","last_updated_date":"2015-03-31T12:00:00Z","reference_number":"EMA/201512/2015","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-template-eu-medicines-agencies-network-strategy-2020-working-together-improve-health_en.doc"},
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    {"id":"26516","name":"Presentation - Welcome to HunPedNet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T16:02:00Z","last_updated_date":"2018-06-18T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-welcome-hunpednet_en.pdf"},
    {"id":"26517","name":"Report of the CVMP on the Safety Evaluation of Steroidal Sex Hormones in particular for 17β-Oestradiol, Progesterone, Altrenogest, Flugestone acetate and Norgestomet in the Light of New Data/Information made available b...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2004-12-21T00:09:21Z","last_updated_date":"2004-12-21T00:09:21Z","reference_number":"EMEA/CVMP/885/99","document_url":"https://www.ema.europa.eu/en/documents/report/report-cvmp-safety-evaluation-steroidal-sex-hormones-particular-17i2-oestradiol-progesterone-altrenogest-flugestone-acetate-and-norgestomet-light-new-datainformation-made-available-b_en.pdf"},
    {"id":"26519","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 8-10 October 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-10-17T18:20:00Z","last_updated_date":"2014-10-17T18:20:00Z","reference_number":"EMA/PDCO/623408/2014 ","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-8-10-october-2014_en.pdf"},
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    {"id":"26525","name":"Withdrawal letter: Egranli","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2014-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-egranli_en.pdf"},
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    {"id":"26533","name":"Bacterial lysate of haemophilus influenzae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus mitis / streptococcus pneumoniae / streptococcus pyogenes, bacterial lysate of ... - List of nationally authorised medicines","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T13:00:00Z","last_updated_date":"2016-12-14T13:13:00Z","reference_number":"EMA/807596/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/bacterial-lysate-haemophilus-influenzae-klebsiella-pneumoniae-moraxella-catarrhalis-staphylococcus-aureus-streptococcus-mitis-streptococcus-pneumoniae-streptococcus-pyogenes-bacterial-lysate-list_en.pdf"},
    {"id":"26534","name":"Cardioxane Article 13 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-26T11:42:00Z","last_updated_date":"2017-07-26T11:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cardioxane-article-13-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cardioxane-article-13-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cardioxane-article-13-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cardioxane-article-13-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cardioxane-article-13-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cardioxane-article-13-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cardioxane-article-13-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cardioxane-article-13-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cardioxane-article-13-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cardioxane-article-13-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cardioxane-article-13-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cardioxane-article-13-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cardioxane-article-13-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cardioxane-article-13-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cardioxane-article-13-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cardioxane-article-13-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cardioxane-article-13-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cardioxane-article-13-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cardioxane-article-13-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cardioxane-article-13-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cardioxane-article-13-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cardioxane-article-13-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cardioxane-article-13-referral-annex-ii_sv.pdf"}},
    {"id":"26536","name":"Committee for Orphan Medicinal Products: January 2006 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-01-12T01:00:00Z","last_updated_date":"2006-01-12T01:00:00Z","reference_number":"EMEA/COMP/11156/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-january-2006-meeting_en.pdf"},
    {"id":"26538","name":"Consumer safety and MRLs, Isaura Duarte, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/consumer-safety-and-mrls-isaura-duarte-ema_en.pdf"},
    {"id":"26541","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 10-13 December 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-12-19T13:00:00Z","last_updated_date":"2012-12-19T13:00:00Z","reference_number":"EMA/CHMP/732295/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-10-13-december-2012_en.pdf"},
    {"id":"26542","name":"EU/3/02/117: Public summary of positive opinion for orphan designation of boswellia serrata resin extract for the treatment of peritumoral oedema derived from brain tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-23T00:00:00Z","last_updated_date":"2007-02-23T00:00:00Z","reference_number":"EMEA/COMP/2247/02 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302117-public-summary-positive-opinion-orphan-designation-boswellia-serrata-resin-extract-treatment-peritumoral-oedema-derived-brain-tumours_en.pdf"},
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    {"id":"26552","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed mRNA sequences encoding six non-small cell lung cancer (NSCLC) associated antigens","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:45:00Z","last_updated_date":"2017-02-28T14:45:00Z","reference_number":"EMA/126624/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-transcribed-mrna-sequences-encoding-six-non-small-cell-lung-cancer-nsclc-associated-antigens_en.pdf"},
    {"id":"26553","name":"Final Community herbal monograph on Cichorium intybus L., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-03-14T16:00:00Z","last_updated_date":"2013-03-14T16:00:00Z","reference_number":"EMA/HMPC/121816/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-cichorium-intybus-l-radix_en.pdf"},
    {"id":"26556","name":"Paraffin liquid: List of nationally authorised medicinal products - PSUSA/00009251/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-10-17T16:59:48Z","reference_number":"EMA/447158/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/paraffin-liquid-list-nationally-authorised-medicinal-products-psusa00009251201510_en.pdf"},
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    {"id":"26561","name":"EU/3/13/1179: Public summary of opinion on orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains for the treatment of growth-hormone deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-13T02:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/COMP/440859/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131179-public-summary-opinion-orphan-designation-recombinant-human-growth-hormone-modified-fusion-two-hydrophilic-polypeptide-chains-treatment-growth-hormone-deficiency_en.pdf"},
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    {"id":"26571","name":"Agenda for the 75th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"EMA/MB/47692/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-75th-meeting-management-board_en.pdf"},
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    {"id":"26573","name":"Presentation - New European Union pharmacovigilance legislation. Innovative industry’s perspective on implementation. First year experience (Laurent Auclert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-european-union-pharmacovigilance-legislation-innovative-industrys-perspective-implementation-first-year-experience-laurent-auclert_en.pdf"},
    {"id":"26574","name":"Presentation - The use of historical control data to assess the benefits of new therapies: A case study of blinatumomab versus standard therapy of adults relapsed/refractory acute lymphoblastic leukaemia (Maurille Feudjo...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-historical-control-data-assess-benefits-new-therapies-case-study-blinatumomab-versus-standard-therapy-adults-relapsedrefractory-acute-lymphoblastic-leukaemia-maurille-feudjo_en.pdf"},
    {"id":"26576","name":"Overview of comments received on 'guideline on clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia' - Revision 1","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-23T11:45:00Z","last_updated_date":"2013-01-23T11:45:00Z","reference_number":"EMA/CHMP/57220/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-including-depot-preparations-treatment-schizophrenia-revision-1_en.pdf"},
    {"id":"26577","name":"Epoprostenol: List of nationally authorised medicinal products    - PSUSA/00001242/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-24T15:20:00Z","last_updated_date":"2018-01-24T15:27:41Z","reference_number":"EMA/46884/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/epoprostenol-list-nationally-authorised-medicinal-products-psusa00001242201703_en.pdf"},
    {"id":"26578","name":"Questions and answers on recommendation for the refusal of the marketing authorisation for Vedrop International non-proprietary name (INN): tocofersolan","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T00:09:21Z","last_updated_date":"2009-01-22T00:09:21Z","reference_number":"EMEA/30797/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-vedrop-international-non-proprietary-name-inn-tocofersolan_en.pdf"},
    {"id":"26580","name":"Public summary of opinion on orphan designation: Nalbuphine hydrochloride for the treatment of uraemic pruritus","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/504453/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-nalbuphine-hydrochloride-treatment-uraemic-pruritus_en.pdf"},
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    {"id":"26609","name":"Final community herbal monograph on Humulus lupulus L., flos - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-08-07T02:00:00Z","last_updated_date":"2014-08-07T02:00:00Z","reference_number":"EMA/HMPC/682384/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-humulus-lupulus-l-flos-revision-1_en.pdf"},
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    {"id":"26611","name":"FGK Representative Service GmbH withdraws its marketing authorisation application for Memantine FGK (memantine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"EMA/18787/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/fgk-representative-service-gmbh-withdraws-its-marketing-authorisation-application-memantine-fgk-memantine_en.pdf"},
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    {"id":"26639","name":"Withdrawal assessment report for Pioglitazone Ratio","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2012-07-12T13:55:00Z","last_updated_date":"2012-07-12T13:55:00Z","reference_number":"EMA/391408/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-pioglitazone-ratio_en.pdf"},
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    {"id":"26642","name":"EMA gets ready for relocation decision","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-11-07T14:00:00Z","last_updated_date":"2017-11-07T14:00:00Z","reference_number":"EMA/712386/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-gets-ready-relocation-decision_en.pdf"},
    {"id":"26645","name":"Joint audit programme for EEA GMP inspectorates: Procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-19T02:00:00Z","last_updated_date":"2021-08-02T16:26:00Z","reference_number":"EMA/694531/2017 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-eea-gmp-inspectorates-procedure_en.pdf"},
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    {"id":"26687","name":"Superseded assessment report on Pimpinella anisum  L.","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-06-17T02:00:00Z","last_updated_date":"2014-06-17T02:00:00Z","reference_number":"EMEA/HMPC/137421/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-pimpinella-anisum-l_en.pdf"},
    {"id":"26691","name":"Update on the implementation of the EU Telematics strategy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-06-11T02:09:21Z","last_updated_date":"2009-06-11T02:09:21Z","reference_number":"EMEA/287743/2009","document_url":"https://www.ema.europa.eu/en/documents/report/update-implementation-eu-telematics-strategy_en.pdf-1"},
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    {"id":"26698","name":"EU/3/11/892: Public summary of opinion on orphan designation: 5-[1-(2,6-dichlorobenzyl)piperidin-4-ylmethoxy]quinazoline-2,4-diamine dihydrochloride for the treatment of 5q spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-09-21T02:00:00Z","last_updated_date":"2011-09-21T02:00:00Z","reference_number":"EMA/COMP/512027/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311892-public-summary-opinion-orphan-designation-5-1-26-dichlorobenzylpiperidin-4-ylmethoxyquinazoline-24-diamine-dihydrochloride-treatment-5q-spinal-muscular-atrophy_en.pdf"},
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    {"id":"26816","name":"Presentation - How the EMA EU support treatment development in rare diseases (Laura Fregonese)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-ema-eu-support-treatment-development-rare-diseases-laura-fregonese_en.pdf"},
    {"id":"26817","name":"EU/3/05/291: Public summary of positive opinion for orphan designation of human monoclonal antibody against HLA-DR for the treatment of Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/192749/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305291-public-summary-positive-opinion-orphan-designation-human-monoclonal-antibody-against-hla-dr-treatment-hodgkins-lymphoma_en.pdf"},
    {"id":"26818","name":"Agenda - Collaboration on neonatal issues between researchers and the European Medicines Agency","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-03-10T11:28:00Z","last_updated_date":"2015-03-10T11:28:00Z","reference_number":"EMA/66870/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-collaboration-neonatal-issues-between-researchers-and-european-medicines-agency_en.pdf"},
    {"id":"26822","name":"Opinion of the HMPC on a European Union herbal monograph on Matricaria recutita L., flos - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-04-05T17:30:00Z","last_updated_date":"2016-04-05T17:30:00Z","reference_number":"EMA/HMPC/M/H/170","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-matricaria-recutita-l-flos-first-version_en.pdf"},
    {"id":"26824","name":"CHMP positive summary of opinion for Myclausen","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2010-07-23T02:00:00Z","reference_number":"EMA/CHMP/439259/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-myclausen_en.pdf"},
    {"id":"26827","name":"Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-30T14:00:00Z","last_updated_date":"2016-10-17T20:25:28Z","reference_number":"EMA/648833/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cilostazol-list-nationally-authorised-medicinal-products-psusa00010209201602_en.pdf"},
    {"id":"26829","name":"Cumulative index of Pharmacovigilance Working Party monthly reports","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T01:00:00Z","last_updated_date":"2012-07-26T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/cumulative-index-pharmacovigilance-working-party-monthly-reports_en.pdf"},
    {"id":"26832","name":"Revised implementing rules to the Fee Regulation as of 1 April 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/MB/112878/2013","document_url":"https://www.ema.europa.eu/en/documents/other/revised-implementing-rules-fee-regulation-1-april-2013_en.pdf"},
    {"id":"26833","name":"Presentation - Encouraging paediatric clinical research in the European Union – current challenges (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-encouraging-paediatric-clinical-research-european-union-current-challenges-isabelle-moulon_en.pdf"},
    {"id":"26835","name":"Gentamicin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/003/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gentamicin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"26836","name":"Draft Community list entry on Mentha x piperita L., aetheroleum","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-08T02:00:00Z","last_updated_date":"2008-05-08T02:00:00Z","reference_number":"EMEA/HMPC/189245/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-mentha-x-piperita-l-aetheroleum_en.pdf"},
    {"id":"26837","name":"Valproate - Article 31 - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-04-29T02:00:00Z","last_updated_date":"2011-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valproate-article-31-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valproate-article-31-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valproate-article-31-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valproate-article-31-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valproate-article-31-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valproate-article-31-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valproate-article-31-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valproate-article-31-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valproate-article-31-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valproate-article-31-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valproate-article-31-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valproate-article-31-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valproate-article-31-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valproate-article-31-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valproate-article-31-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valproate-article-31-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valproate-article-31-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valproate-article-31-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valproate-article-31-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valproate-article-31-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valproate-article-31-annex-i_sv.pdf"}},
    {"id":"26838","name":"Presentation - Norms related to ethical clinical trials - Patients' perspective (Nikos Dedes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-norms-related-ethical-clinical-trials-patients-perspective-nikos-dedes_en.pdf"},
    {"id":"26839","name":"List of participants of the European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf-1"},
    {"id":"26840","name":"CTI Life Sciences Ltd. withdraws its marketing authorisation application for Opaxio (paclitaxel poliglumex)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/601200/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/cti-life-sciences-ltd-withdraws-its-marketing-authorisation-application-opaxio-paclitaxel-poliglumex_en.pdf"},
    {"id":"26841","name":"Retinoid Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/retinoid-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/retinoid-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/retinoid-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/retinoid-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/retinoid-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/retinoid-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/retinoid-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/retinoid-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/retinoid-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/retinoid-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/retinoid-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/retinoid-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/retinoid-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/retinoid-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/retinoid-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/retinoid-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/retinoid-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/retinoid-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/retinoid-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/retinoid-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/retinoid-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/retinoid-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"26842","name":"Withdrawal assessment report for Tygacil","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/382036/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tygacil_en.pdf"},
    {"id":"26845","name":"EU/3/09/640: Public summary of positive opinion for orphan designation of pegylated recombinant human factor IX for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-09T02:00:00Z","last_updated_date":"2017-08-03T02:00:00Z","reference_number":"EMEA/COMP/214529/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309640-public-summary-positive-opinion-orphan-designation-pegylated-recombinant-human-factor-ix-treatment-haemophilia-b_en.pdf"},
    {"id":"26846","name":"Presentation - Licensing requirements for vaccines: US perspective (Larry R. Ludemann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-licensing-requirements-vaccines-us-perspective-larry-r-ludemann_en.pdf"},
    {"id":"26847","name":"Final opinion of the HMPC on a European Union herbal monograph on Melilotus officinalis (L.) Lam., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-04-23T16:10:00Z","last_updated_date":"2018-04-23T16:10:00Z","reference_number":"EMA/HMPC/M/H/0214","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-melilotus-officinalis-l-lam-herba_en.pdf"},
    {"id":"26851","name":"Assessment of the quality of medicinal products containing existing/ known active substances","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-07-10T02:09:21Z","last_updated_date":"2007-07-10T02:09:21Z","reference_number":"EMEA/CHMP/CVMP/QWP/450653/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/assessment-quality-medicinal-products-containing-existing-known-active-substances_en.pdf"},
    {"id":"26854","name":"Presentation - Evaluation of patient reporting to the Yellow Card System","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:13Z","last_updated_date":"2011-06-24T22:06:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evaluation-patient-reporting-yellow-card-system_en.pdf"},
    {"id":"26856","name":"Speaker profiles - Best expertise vs conflicts of interests: Striking the right balance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-06T11:00:00Z","last_updated_date":"2013-09-06T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/speaker-profiles-best-expertise-vs-conflicts-interests-striking-right-balance_en.pdf"},
    {"id":"26858","name":"Agenda and registration form - EudraVigilance training on electronic reporting of individual case safety reports in the European Economic Area","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T14:00:01Z","last_updated_date":"2015-09-16T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-european-economic-area_en.pdf"},
    {"id":"26859","name":"Jean-Marc Ferran (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/jean-marc-ferran-cv_en.pdf"},
    {"id":"26862","name":"Annex VI - List of flupirtine-containing medicinal products in the EU","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2014-02-26T15:00:00Z","last_updated_date":"2017-09-27T12:30:00Z","reference_number":"EMA/68528/2014 CORRECTION 4*","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-vi-list-flupirtine-containing-medicinal-products-eu_en.pdf"},
    {"id":"26863","name":"Draft list of references for assessment of: Absinthii herba Artemisia absinthium L., herba (wormwood herb)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/234497/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-absinthii-herba-artemisia-absinthium-l-herba-wormwood-herb_en.pdf"},
    {"id":"26864","name":"Gutal Article 33(4) referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-11-26T01:00:00Z","last_updated_date":"2015-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gutal-article-334-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gutal-article-334-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gutal-article-334-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gutal-article-334-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gutal-article-334-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gutal-article-334-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gutal-article-334-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gutal-article-334-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gutal-article-334-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gutal-article-334-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gutal-article-334-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gutal-article-334-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gutal-article-334-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gutal-article-334-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gutal-article-334-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gutal-article-334-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gutal-article-334-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gutal-article-334-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gutal-article-334-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gutal-article-334-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gutal-article-334-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gutal-article-334-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gutal-article-334-referral-annex-i-ii-iii_sv.pdf"}},
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    {"id":"26869","name":"Methyl nicotinate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-07-01T02:00:00Z","last_updated_date":"1998-07-01T02:00:00Z","reference_number":"EMEA/MRL/465/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/methyl-nicotinate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"26871","name":"Simvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"26898","name":"Committee for medicinal products for human use, summary of positive opinion for Intelence","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-06-26T02:00:00Z","last_updated_date":"2008-06-26T02:00:00Z","reference_number":"EMEA/CHMP/44000/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-intelence_en.pdf"},
    {"id":"26899","name":"Considerations on methodology, Study design and statistical Approaches - Gerard Pons","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-11T02:09:21Z","last_updated_date":"2006-10-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/considerations-methodology-study-design-and-statistical-approaches-gerard-pons_en.pdf"},
    {"id":"26902","name":"Enpr-EMA European Network of Paediatric Research at the European Medicines Agency - Background information","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-10-22T15:30:00Z","last_updated_date":"2012-10-22T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/enpr-ema-european-network-paediatric-research-european-medicines-agency-background-information_en.ppt"},
    {"id":"26903","name":"Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-12T18:00:00Z","last_updated_date":"2014-03-12T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"26905","name":"Febantel (Extrapolation to all ruminants): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/MRL/867/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/febantel-extrapolation-all-ruminants-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"26911","name":"Superseded list of bibliographic references supporting the HMPC assessment report on Cassia senna L. and Cassia angustifolia Vahl, folium (EMEA/HMPC/51868/2006) and the HMPC assessment report on Cassia senna L., fructus and Cassia ...","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2007-04-27T02:09:00Z","last_updated_date":"2007-04-27T02:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-bibliographic-references-supporting-hmpc-assessment-report-cassia-senna-l-and-cassia-angustifolia-vahl-folium-emeahmpc518682006-and-hmpc-assessment-report-cassia-senna-l-fructus-and_en.pdf"},
    {"id":"26913","name":"Public statement on Ribavirin BioPartners - Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T12:40:00Z","last_updated_date":"2013-05-06T12:40:00Z","reference_number":"EMA/223731/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ribavirin-biopartners-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"26917","name":"CVMP/SAGAM recommendations on antimicrobials - Karolina Tà¶rneke","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:09:21Z","last_updated_date":"2009-05-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/cvmpsagam-recommendations-antimicrobials-karolina-taprneke_en.pdf"},
    {"id":"26918","name":"Presentation - Use of quantitative tools for study planning purposes and study design optimisation (V. Gigante, AIFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-quantitative-tools-study-planning-purposes-and-study-design-optimisation-v-gigante-aifa_en.pdf"},
    {"id":"26919","name":"Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from human burn eschar and debrided adipose tissue cells, seeded onto ac...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T13:00:00Z","last_updated_date":"2016-04-12T13:00:00Z","reference_number":"EMA/241022/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-co-culture-keratinocytes-and-mesenchymal-stem-cells-isolated-human-burn-eschar-and-debrided-adipose-tissue-cells-seeded-ac_en.pdf"},
    {"id":"26921","name":"Ketoconazole Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T02:00:00Z","last_updated_date":"2014-06-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoconazole-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ketoconazole-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ketoconazole-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ketoconazole-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ketoconazole-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ketoconazole-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ketoconazole-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ketoconazole-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ketoconazole-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ketoconazole-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ketoconazole-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ketoconazole-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ketoconazole-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ketoconazole-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ketoconazole-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ketoconazole-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ketoconazole-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ketoconazole-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ketoconazole-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ketoconazole-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ketoconazole-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ketoconazole-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ketoconazole-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"26923","name":"EU/3/04/198: Public summary of positive opinion for orphan designation of human monoclonal antibody against CD4 for the treatment of cutaneous T cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMEA/COMP/135/04 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304198-public-summary-positive-opinion-orphan-designation-human-monoclonal-antibody-against-cd4-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"26924","name":"CVMP summary of positive opinion for Oxybee","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T17:30:00Z","last_updated_date":"2017-09-08T17:30:00Z","reference_number":"EMA/CVMP/499119/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-oxybee_en.pdf"},
    {"id":"26927","name":"Public statement on Clopidogrel Teva Pharma B.V.: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-02-03T01:00:00Z","last_updated_date":"2015-02-03T01:00:00Z","reference_number":"EMA/748663/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-teva-pharma-bv-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"26928","name":"EMEA Management Board considers road map 2010 and welcomes increase in new applications for human medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-10-01T02:09:21Z","last_updated_date":"2004-10-01T02:09:21Z","reference_number":"EMEA/92160/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-management-board-considers-road-map-2010-and-welcomes-increase-new-applications-human-medicines_en.pdf"},
    {"id":"26933","name":"EU/3/14/1321: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene for the treatment of Crigler-Najjar syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/COMP/457011/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141321-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-ugt1a1-gene-treatment-crigler-najjar-syndrome_en.pdf"},
    {"id":"26935","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam, December 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-06-14T17:00:00Z","last_updated_date":"2018-06-14T17:00:00Z","reference_number":"Course # 18599","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-amsterdam-december-2018_en.pdf"},
    {"id":"26938","name":"Report - Workshop on development of new antibacterial medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T12:40:00Z","last_updated_date":"2013-09-25T12:40:00Z","reference_number":"EMA/493109/2013","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-development-new-antibacterial-medicines_en.pdf"},
    {"id":"26939","name":"Committee for Proprietary Medicinal Products (CPMP) 26th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-04-18T02:00:00Z","last_updated_date":"1997-04-18T02:00:00Z","reference_number":"CPMP/341/97","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-26th-plenary-meeting_en.pdf"},
    {"id":"26940","name":"Presentation - GMP inspection system in the EEA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gmp-inspection-system-eea_en.pdf"},
    {"id":"26941","name":"Guideline on the chemistry of active substances for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-01-19T15:20:00Z","last_updated_date":"2018-01-19T15:20:00Z","reference_number":"EMA/CVMP/QWP/707366/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-chemistry-active-substances-veterinary-medicinal-products_en.pdf"},
    {"id":"26942","name":"EU/3/16/1655: Public summary of opinion on orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/240771/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161655-public-summary-opinion-orphan-designation-tyr-met-phe-pro-asn-ala-pro-tyr-leu-ser-gly-gln-ala-tyr-met-phe-pro-asn-ala-pro-tyr-leu-pro-ser-cys-leu-glu-ser-arg-ser-asp-glu-leu-val-arg-his-his_en.pdf"},
    {"id":"26944","name":"EMEA recommends restricted use of oral norfloxacin-containing medicines in urinary infections","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/380260/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-restricted-use-oral-norfloxacin-containing-medicines-urinary-infections_en.pdf"},
    {"id":"26949","name":"Public statement: EMEA opinions on Sildenafil citrate (Viagra)","type":"position","status":"unknown","consultation_date":"","first_published_date":"1998-07-28T02:00:00Z","last_updated_date":"1998-07-28T02:00:00Z","reference_number":"CPMP/1031/98 rev. 1","document_url":"https://www.ema.europa.eu/en/documents/position/public-statement-emea-opinions-sildenafil-citrate-viagra_en.pdf"},
    {"id":"26950","name":"Parallel consultation: briefing document template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-03-31T14:00:00Z","last_updated_date":"2022-10-06T13:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/parallel-consultation-briefing-document-template_en.docx"},
    {"id":"26951","name":"Questions and answers on the withdrawal of the marketing-authorisation application for Ditelos (strontium ranelate / cholecalciferol)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/249569/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-ditelos-strontium-ranelate-cholecalciferol_en.pdf"},
    {"id":"26953","name":"Mutual recognition agreements between the European Union and the respective parties Australia, Canada, New Zealand and Switzerland - Guide to the mutual recognition agreements in operation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2003-05-05T02:00:00Z","last_updated_date":"2003-05-05T02:00:00Z","reference_number":"EMEA/MRA/22/03 final","document_url":"https://www.ema.europa.eu/en/documents/other/mutual-recognition-agreements-between-european-union-and-respective-parties-australia-canada-new-zealand-and-switzerland-guide-mutual-recognition-agreements-operation_en.pdf"},
    {"id":"26955","name":"Diclofenac Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-31T18:00:00Z","last_updated_date":"2012-10-31T18:00:00Z","reference_number":"EMA/693599/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-review-started_en.pdf"},
    {"id":"26956","name":"EU/3/15/1538: Public summary of opinion on orphan designation: Fixed-dose combination of fosfomycin disodium and tobramycin for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/501084/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151538-public-summary-opinion-orphan-designation-fixed-dose-combination-fosfomycin-disodium-and-tobramycin-treatment-cystic-fibrosis_en.pdf"},
    {"id":"26958","name":"Clinical trials in Europe - Introductory remarks, Dr Chantal Bà©lorgey","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/clinical-trials-europe-introductory-remarks-dr-chantal-baclorgey_en.pdf"},
    {"id":"26959","name":"Famvir - Article 30 Referral - PI","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2010-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/famvir-article-30-referral-pi_en.pdf"},
    {"id":"26960","name":"Core SPC for human Varicella immunoglobulin for intramuscular use\n\n(CPMP/BPWG/3726/02)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"CPMP/BPWG/3726/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/core-spc-human-varicella-immunoglobulin-intramuscular-use-cpmpbpwg372602_en.pdf"},
    {"id":"26961","name":"Zinbryta Article-20 referral - PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T02:00:00Z","last_updated_date":"2017-10-27T02:00:00Z","reference_number":"EMEA/H/A-20/1456/C/003862/0010","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-prac-recommends-further-restrictions-multiple-sclerosis-medicine-zinbryta-due-risk-serious-liver-damage_en.pdf"},
    {"id":"26962","name":"Organisational matters - CHMP meeting 25-28 January 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T10:45:00Z","last_updated_date":"2016-02-03T10:45:00Z","reference_number":"EMA/67044/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-25-28-january-2016_en.pdf"},
    {"id":"26964","name":"Committee for medicinal products for veterinary use summary of opinion: Gripovac 3: International Non-proprietary Names (INN): Inactivated vaccine against swine influenza in pigs","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-11-13T01:09:21Z","last_updated_date":"2018-09-04T16:30:00Z","reference_number":"EMEA/CVMP/661084/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-gripovac-3-international-non-proprietary-names-inn-inactivated-vaccine-against-swine-influenza-pigs_en.pdf"},
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    {"id":"26979","name":"Contract 2006/118-594: Multi-beneficiary programme on participation of Croatia and Turkey in certain Community agencies in 2006 and 2007: Second progress report to the European Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2007-06-21T02:09:21Z","last_updated_date":"2007-06-21T02:09:21Z","reference_number":"EMEA/279906/2007","document_url":"https://www.ema.europa.eu/en/documents/report/contract-2006118-594-multi-beneficiary-programme-participation-croatia-and-turkey-certain-community-agencies-2006-and-2007-second-progress-report-european-commission_en.pdf"},
    {"id":"26981","name":"Safety monitoring and reporting, Dr Ingrid Wallenbeck","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/safety-monitoring-and-reporting-dr-ingrid-wallenbeck_en.pdf"},
    {"id":"26982","name":"Opinion following an article 6(13) referral for Cobactan DC and its associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-12T02:00:00Z","last_updated_date":"2014-08-12T02:00:00Z","reference_number":"EMA/250892/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-613-referral-cobactan-dc-and-its-associated-names_en.pdf"},
    {"id":"26983","name":"Somatropin - Article 107 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-04-23T02:00:00Z","last_updated_date":"2012-04-23T02:00:00Z","reference_number":"EMA/110423/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/somatropin-article-107-referral-assessment-report_en.pdf"},
    {"id":"26986","name":"Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-spe...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-01-03T17:54:00Z","last_updated_date":"2017-01-03T17:54:00Z","reference_number":"EMA/CHMP/805630/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/levodopacarbidopaentacapone-film-coated-tablet-200-mg50-mg200-mg-175-mg4375-mg200-mg-150-mg375-mg200-mg-125-mg3125-mg200-mg-100-mg25-mg200-mg-75-mg1875-mg200-mg-and-50-mg125-mg200-mg-product-spe_en.pdf"},
    {"id":"26987","name":"EU/3/13/1220: Public summary of opinion on orphan designation: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2015-06-08T02:00:00Z","reference_number":"EMA/COMP/698335/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131220-public-summary-opinion-orphan-designation-poly2-4-1-carboxy-2-hexadecylcarbamoylethylsulfanyl-23-bis2-2s-2-2-2r-2-carbamoyl-2-2s-1-ethoxy-3-3-hydroxy-4oxo-14-dihydropyridi_en.pdf"},
    {"id":"26990","name":"Download EPS - Species pictograms - Goat","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-goat_en.zip"},
    {"id":"26991","name":"Bronopol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/459/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bronopol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"26992","name":"Presentation - Holistic approach to paediatric research: multistakeholder collaboration (C. Ollivier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:04:00Z","last_updated_date":"2018-06-18T12:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-multistakeholder-collaboration-c-ollivier_en.pdf"},
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    {"id":"26996","name":"Ex ante publicity of a negotiated procedure: EMA/2016/42/COM – Promotional products","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-05-10T16:30:00Z","last_updated_date":"2016-05-10T16:30:00Z","reference_number":"EMA/269828/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201642com-promotional-products_en.pdf"},
    {"id":"26997","name":"Concept paper on the classification of veterinary medicinal products authorised by the community","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-09-18T02:00:00Z","last_updated_date":"2007-09-18T02:00:00Z","reference_number":"EMEA/CVMP/358850/2007-CONS","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-classification-veterinary-medicinal-products-authorised-community_en.pdf"},
    {"id":"26998","name":"CHMP summary of positive opinion for Fotivda","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T14:00:00Z","last_updated_date":"2017-06-23T14:00:00Z","reference_number":"EMA/CHMP/333095/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fotivda_en.pdf"},
    {"id":"26999","name":"CVMP monthly report of application procedures, guidelines and related documents: April 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T12:40:00Z","last_updated_date":"2013-05-17T12:40:00Z","reference_number":"EMA/249895/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-april-2013_en.pdf"},
    {"id":"27002","name":"“EMA ready to address challenges ahead”","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"EMA/824301/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-ready-address-challenges-ahead_en.pdf"},
    {"id":"27004","name":"Recommendation to marketing authorisation holders, highlighting recent measures in the veterinary field to promote replacement, reduction, and refinement (3Rs) measures described in the European Pharmacopoeia - Applicabl...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-01-24T16:30:00Z","last_updated_date":"2018-02-16T11:00:00Z","reference_number":"EMA/CHMP/CVMP/3Rs/614768/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-marketing-authorisation-holders-highlighting-recent-measures-veterinary-field-promote-replacement-reduction-and-refinement-3rs-measures-described-european-pharmacopoeia-applicabl_en.pdf"},
    {"id":"27006","name":"Superseded assessment report for the development of community monographs and for inclusion of  herbal substance(s), preparation(s) or combinations thereof in the list Melilotus officinalis (L.) Lam., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2018-04-23T02:00:00Z","reference_number":"EMEA/HMPC/354183/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-development-community-monographs-and-inclusion-herbal-substances-preparations-or-combinations-thereof-list-melilotus-officinalis-l-lam-herba_en.pdf"},
    {"id":"27008","name":"A Workshop on Bio-Markers EMEA / CHMP meeting - Introduction - Daniel Brasseur","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-12-16T00:09:21Z","last_updated_date":"2005-12-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/workshop-bio-markers-emea-chmp-meeting-introduction-daniel-brasseur_en.pdf"},
    {"id":"27009","name":"News bulletin for small and medium-sized enterprises - Issue 36","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2016-08-03T18:05:00Z","last_updated_date":"2016-08-03T18:05:00Z","reference_number":"Issue 36","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-36_en.pdf"},
    {"id":"27010","name":"Levonorgestrel / ethinylestradiol, ethinylestradiol(combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-05T14:00:00Z","last_updated_date":"2017-09-06T17:19:00Z","reference_number":"EMA/580243/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/levonorgestrel-ethinylestradiol-ethinylestradiolcombination-pack-list-nationally-authorised-medicinal-products-psusa00010442201701_en.pdf"},
    {"id":"27011","name":"CVMP post-authorisation summary of positive opinion for Draxxin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/CVMP/156049/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-draxxin_en.pdf-0"},
    {"id":"27014","name":"Draft guideline on the evaluation of medicinal products in the treatment of primary osteoporosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-12-14T01:00:00Z","last_updated_date":"2005-12-14T01:00:00Z","reference_number":"CPMP/EWP/552/95 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-medicinal-products-treatment-primary-osteoporosis_en.pdf"},
    {"id":"27021","name":"Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (20 September 2016)","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-09-01T15:31:00Z","last_updated_date":"2017-01-03T14:31:00Z","reference_number":"EMA/428004/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-20-september-2016_en.pdf"},
    {"id":"27023","name":"Attachment 1 for change of scientific opinion holder","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-08-05T17:20:00Z","last_updated_date":"2014-08-05T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/attachment-1-change-scientific-opinion-holder_en.doc"},
    {"id":"27025","name":"Monthly report - Pharmacovigilance Working Party (PhVWP) April 2011 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-04-20T02:00:00Z","last_updated_date":"2011-04-20T02:00:00Z","reference_number":"EMA/CHMP/PhVWP/298094/2011","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-april-2011-plenary-meeting_en.pdf"},
    {"id":"27026","name":"European Medicines Agency receives second application for human pandemic influenza vaccine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-02-24T01:00:00Z","last_updated_date":"2006-02-24T01:00:00Z","reference_number":"EMEA/35322/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-receives-second-application-human-pandemic-influenza-vaccine_en.pdf"},
    {"id":"27028","name":"Final summary record – EDC systems and risk-based monitoring in Clinical Trials","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-06-26T18:20:00Z","last_updated_date":"2017-06-26T18:20:00Z","reference_number":"EMA/729273/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/final-summary-record-edc-systems-and-risk-based-monitoring-clinical-trials_en.pdf"},
    {"id":"27029","name":"PRAC signal recommendations requesting an update of the product information – September 2012 to July 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-11-28T12:30:00Z","last_updated_date":"2014-01-21T17:29:00Z","reference_number":"EMA/PRAC/720475/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/prac-signal-recommendations-requesting-update-product-information-september-2012-july-2013_en.pdf"},
    {"id":"27031","name":"CHMP post-authorisation summary of positive opinion for Alimta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/776909/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-alimta_en.pdf"},
    {"id":"27033","name":"Overview of comments received on Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function (EMA/CHMP/ 83874/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-02-02T10:09:59Z","last_updated_date":"2016-02-02T10:09:59Z","reference_number":"EMA/CHMP/725881/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-evaluation-pharmacokinetics-medicinal-products-patients-decreased-renal-function-emachmp-838742014_en.pdf"},
    {"id":"27034","name":"EU/3/08/608: Public summary of positive opinion for orphan designation of yttrium (90Y)-DOTA-radiolabelled humanized monoclonal antibody against mucin 1 for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-26T02:00:00Z","last_updated_date":"2020-03-06T02:00:00Z","reference_number":"EMEA/COMP/671125/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308608-public-summary-positive-opinion-orphan-designation-yttrium-90y-dota-radiolabelled-humanized-monoclonal-antibody-against-mucin-1-treatment-pancreatic-cancer_en.pdf"},
    {"id":"27036","name":"Opinion following an Article 33(4) referral for Dolovet: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T01:59:00Z","last_updated_date":"2008-06-02T01:59:00Z","reference_number":"EMEA/532160/2007 – Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-dolovet-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-dolovet-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-dolovet-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-dolovet-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-dolovet-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-dolovet-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-dolovet-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-dolovet-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-dolovet-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-dolovet-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-dolovet-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-dolovet-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-dolovet-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-dolovet-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-dolovet-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-dolovet-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-dolovet-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-dolovet-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-dolovet-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-dolovet-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-dolovet-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-dolovet-background-information_sv.pdf"}},
    {"id":"27038","name":"Xofigo Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T13:00:00Z","last_updated_date":"2017-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/xofigo-article-20-procedure-notification_en.pdf"},
    {"id":"27039","name":"EU/3/04/231: Public summary of positive opinion for orphan designation of deferoxamine mesilate for the treatment of traumatic spinal-cord injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMEA/COMP/178558/2004 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304231-public-summary-positive-opinion-orphan-designation-deferoxamine-mesilate-treatment-traumatic-spinal-cord-injury_en.pdf"},
    {"id":"27041","name":"CHMP post-authorisation summary of positive opinion for Irbesartan Hydrochlorothiazide Zentiva","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2013-06-28T14:00:00Z","reference_number":"EMA/CHMP/388295/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-irbesartan-hydrochlorothiazide-zentiva_en.pdf"},
    {"id":"27047","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 7-9 August 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-08-16T11:30:00Z","last_updated_date":"2013-08-22T12:50:00Z","reference_number":"EMA/499786/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-7-9-august-2013_en.pdf"},
    {"id":"27050","name":"Workshop report - Making Article 58 and other European Medicines Agency outputs more relevant for non-EU regulators","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-04-26T13:45:00Z","last_updated_date":"2017-04-26T13:45:00Z","reference_number":"EMA/184549/2017","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-making-article-58-and-other-european-medicines-agency-outputs-more-relevant-non-eu-regulators_en.pdf"},
    {"id":"27051","name":"Penethamate (Extension to all mammalian species): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-12-01T01:00:00Z","last_updated_date":"2004-12-01T01:00:00Z","reference_number":"EMEA/MRL/913/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/penethamate-extension-all-mammalian-species-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"27053","name":"Overview of comments received during the first public consultation on 'Guidance on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-11-19T12:50:00Z","last_updated_date":"2014-11-19T12:50:00Z","reference_number":"EMA/CVMP/ERA/102239/2013","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-during-first-public-consultation-guidance-assessment-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpvb-substances-veterinary_en.pdf"},
    {"id":"27056","name":"Initiative of the EU Commission: Follow up to the Public consultation on the future of the pharmaceutical sector - Martin Terberger","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/initiative-eu-commission-follow-public-consultation-future-pharmaceutical-sector-martin-terberger_en.pdf"},
    {"id":"27057","name":"Human medicines highlights - January 2018","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-01-05T13:15:00Z","last_updated_date":"2018-01-05T13:15:00Z","reference_number":"Issue 106","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-january-2018_en.pdf"},
    {"id":"27058","name":"New treatment option for patients with rare blood cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-09-25T14:00:00Z","last_updated_date":"2015-09-25T14:00:00Z","reference_number":"EMA/CHMP/628925/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-treatment-option-patients-rare-blood-cancer_en.pdf"},
    {"id":"27059","name":"Presentation - Meta-analyses of clinical dose response (N. Thomas,  D. Roy, V. Somayaji, K. Sweeney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-meta-analyses-clinical-dose-response-n-thomas-d-roy-v-somayaji-k-sweeney_en.pdf"},
    {"id":"27062","name":"Presentation - EudraVigilance – new functionalities and EudraVigilance access policy (patient access) (S. Brosch, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-new-functionalities-and-eudravigilance-access-policy-patient-access-s-brosch-ema_en.pdf"},
    {"id":"27063","name":"EU/3/06/422: Public summary of positive opinion for orphan designation of paclitaxel (micellar) for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2018-10-04T11:42:00Z","reference_number":"EMEA/COMP/453951/2006 Correction 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306422-public-summary-positive-opinion-orphan-designation-paclitaxel-micellar-treatment-ovarian-cancer_en.pdf"},
    {"id":"27064","name":"Presentation - Safety – immune related adverse events (irAE) focus on non-small cell lung cancer (NSCLC) (Aaron Hansen) - S2.7","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-safety-immune-related-adverse-events-irae-focus-non-small-cell-lung-cancer-nsclc-aaron-hansen-s27_en.pdf"},
    {"id":"27067","name":"Appointment as Accounting Officer of the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2010-06-18T02:00:00Z","reference_number":"EMA/MB/354158/2010","document_url":"https://www.ema.europa.eu/en/documents/other/appointment-accounting-officer-european-medicines-agency_en.pdf"},
    {"id":"27069","name":"Overview of comments received on draft guideline 'clinical trials in small populations'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-07-27T02:00:00Z","last_updated_date":"2006-07-27T02:00:00Z","reference_number":"EMEA/CHMP/EWP/281490/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-trials-small-populations_en.pdf"},
    {"id":"27070","name":"Presentation - Key points from session 2: registries (Christine Keipert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-points-session-2-registries-christine-keipert_en.pdf"},
    {"id":"27071","name":"Assessment report for cilostazol-containing medicinal products","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"EMA/CHMP/428525/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-cilostazol-containing-medicinal-products_en.pdf"},
    {"id":"27073","name":"Enabling science that works for patients – leaflet","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2017-08-10T12:00:00Z","last_updated_date":"2017-10-04T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/enabling-science-works-patients-leaflet_en.pdf"},
    {"id":"27075","name":"Committee for veterinary medicinal products: Meeting of 8 to 9 April 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-04-11T14:59:21Z","last_updated_date":"2003-04-11T14:59:21Z","reference_number":"EMEA/CVMP/369/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-8-9-april-2003_en.pdf"},
    {"id":"27077","name":"Agenda - 2011 European Medicines Agency/IFAH-Europe Info Day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-02-17T01:00:00Z","last_updated_date":"2011-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2011-european-medicines-agencyifah-europe-info-day_en.pdf"},
    {"id":"27080","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Prague","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-prague_en.pdf-0"},
    {"id":"27081","name":"Norgestomet: Note regarding establishment of maximum residue limits - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1993-01-01T01:00:00Z","last_updated_date":"2009-11-04T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/norgestomet-note-regarding-establishment-maximum-residue-limits-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"27082","name":"Public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T16:00:00Z","last_updated_date":"2016-07-27T16:00:00Z","reference_number":"EMA/HMPC/258725/2015 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-use-herbal-medicinal-products-containing-pulegone-and-menthofuran-revision-1_en.pdf"},
    {"id":"27084","name":"CHMP summary of positive opinion for Tovanor Breezhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T14:00:00Z","last_updated_date":"2012-08-07T13:25:00Z","reference_number":"EMA/CHMP/422793/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tovanor-breezhaler_en.pdf"},
    {"id":"27085","name":"EU/3/10/785: Public summary of opinion on orphan designation: Vorinostat for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2013-03-12T13:30:00Z","reference_number":"EMA/381200/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310785-public-summary-opinion-orphan-designation-vorinostat-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"27088","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/438693/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-4"},
    {"id":"27092","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 18 – 21 April 2017","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T20:00:00Z","last_updated_date":"2017-04-21T20:00:00Z","reference_number":"EMA/CHMP/SAWP/253962/2017","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-18-21-april-2017_en.pdf"},
    {"id":"27093","name":"Committee for medicinal products for veterinary use: Meeting of 15-17 September 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-09-18T02:09:21Z","last_updated_date":"2009-09-18T02:09:21Z","reference_number":"EMEA/CVMP/560974/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-15-17-september-2009_en.pdf"},
    {"id":"27096","name":"CVMP post-authorisation summary of positive opinion for Draxxin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-19T01:00:00Z","last_updated_date":"2016-02-19T01:00:00Z","reference_number":"EMEA/CVMP/65204/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-draxxin_en.pdf-1"},
    {"id":"27098","name":"EU/3/17/1965: Public summary of opinion on orphan designation: Metformin and L-citrulline for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/848685/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171965-public-summary-opinion-orphan-designation-metformin-and-l-citrulline-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"27099","name":"Presentation - Supply shortages of medicines in Europe (Franà§ois Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supply-shortages-medicines-europe-franassois-houyez_en.pdf"},
    {"id":"27101","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 July 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-07-13T02:00:00Z","last_updated_date":"2012-07-13T02:00:00Z","reference_number":"EMA/CVMP/449083/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-july-2012_en.pdf"},
    {"id":"27104","name":"Rabies vaccine : CMDh Scientific conclusions and grounds for the variation,\n\namendments to the Product Information, and timetable\n\nfor the implementation: 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    {"id":"27229","name":"European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-27T19:05:00Z","last_updated_date":"2023-02-22T13:25:00Z","reference_number":"EMA/472551/2012 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-policy-changes-scope-paediatric-investigation-plan-decisions_en.pdf"},
    {"id":"27230","name":"Presentation - e-Paediatrics: electronic distribution of application documents to PDCO, and of PDCO opinions and EMA decisions to applicants (Paolo Tomasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T17:00:00Z","last_updated_date":"2016-05-27T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-e-paediatrics-electronic-distribution-application-documents-pdco-and-pdco-opinions-and-ema-decisions-applicants-paolo-tomasi_en.pdf"},
    {"id":"27233","name":"Presentation - Risk communication in a more transparent regulatory environment (Frederic Bouder)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-24T18:30:00Z","last_updated_date":"2013-05-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-communication-more-transparent-regulatory-environment-frederic-bouder_en.pdf"},
    {"id":"27234","name":"CHMP summary of positive opinion for Trumenba","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T13:00:00Z","last_updated_date":"2017-03-24T13:00:00Z","reference_number":"EMA/152667/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trumenba_en.pdf"},
    {"id":"27235","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 17-20 September 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-09-25T17:51:00Z","last_updated_date":"2012-09-25T17:51:00Z","reference_number":"EMA/CHMP/539768/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-during-chmp-meeting-17-20-september-2012_en.pdf"},
    {"id":"27237","name":"Agreal - Article 31 referral - Annex I, II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-01-07T00:08:21Z","last_updated_date":"2008-01-07T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/agreal-article-31-referral-annex-i-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/agreal-article-31-referral-annex-i-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/agreal-article-31-referral-annex-i-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/agreal-article-31-referral-annex-i-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/agreal-article-31-referral-annex-i-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/agreal-article-31-referral-annex-i-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/agreal-article-31-referral-annex-i-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/agreal-article-31-referral-annex-i-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/agreal-article-31-referral-annex-i-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/agreal-article-31-referral-annex-i-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/agreal-article-31-referral-annex-i-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/agreal-article-31-referral-annex-i-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/agreal-article-31-referral-annex-i-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/agreal-article-31-referral-annex-i-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/agreal-article-31-referral-annex-i-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/agreal-article-31-referral-annex-i-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/agreal-article-31-referral-annex-i-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/agreal-article-31-referral-annex-i-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/agreal-article-31-referral-annex-i-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/agreal-article-31-referral-annex-i-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/agreal-article-31-referral-annex-i-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/agreal-article-31-referral-annex-i-ii_sv.pdf"}},
    {"id":"27238","name":"Presentation - Guideline on similar biological medicinal products\n\ncontaining biotechnology-derived proteins as active substance: quality\n\nissues (Niklas Ekman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-quality-issues-niklas-ekman_en.pdf"},
    {"id":"27239","name":"Introduction of a 'regulatory contact point' for marketing authorisation holders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2018-07-26T11:00:00Z","reference_number":"EMA/398931/2016","document_url":"https://www.ema.europa.eu/en/documents/other/introduction-regulatory-contact-point-marketing-authorisation-holders_en.pdf"},
    {"id":"27243","name":"EU/3/08/610: Public summary of positive opinion for orphan designation of\n\ncyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt for the treatment o...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMEA/COMP/11538/2009 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308610-public-summary-positive-opinion-orphan-designation-cyclopropane-11-dicarboxylic-acid-4-67-dimethoxy-quinolin-4-yloxy-phenyl-amide-4-fluoro-phenyl-amide-l-malate-salt-treatment-o_en.pdf"},
    {"id":"27245","name":"Presentation - Lumpy skin disease experience in Greece (Sotiria-Eleni Antoniou and Ioannis Malemis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T11:37:00Z","last_updated_date":"2017-05-18T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lumpy-skin-disease-experience-greece-sotiria-eleni-antoniou-and-ioannis-malemis_en.pdf"},
    {"id":"27246","name":"Lisinopril: List of nationally authorised medicinal products - PSUSA/00001894/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-06T02:00:00Z","last_updated_date":"2016-10-18T10:40:08Z","reference_number":"EMA/388981/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/lisinopril-list-nationally-authorised-medicinal-products-psusa00001894201509_en.pdf"},
    {"id":"27248","name":"Public statement on Parareg: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-05-14T02:00:00Z","last_updated_date":"2009-05-14T02:00:00Z","reference_number":"EMEA/686673/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-parareg-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"27250","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Zalmoxis (allogeneic T cells genetically modified with a retroviral vector encoding","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-09-21T02:00:00Z","last_updated_date":"2016-09-21T02:00:00Z","reference_number":"EMA/COMP/455724/2016 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-zalmoxis-allogeneic-t-cells-genetically-modified-retroviral-vector-encoding_en.pdf"},
    {"id":"27251","name":"European Medicines Agency starts safety review of Diane 35 and its generics","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-02-08T13:00:00Z","last_updated_date":"2013-02-08T13:00:00Z","reference_number":"EMA/82707/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-safety-review-diane-35-and-its-generics_en.pdf"},
    {"id":"27253","name":"Piperazine: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-05-01T02:00:00Z","last_updated_date":"1999-05-01T02:00:00Z","reference_number":"EMEA/MRL/531/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/piperazine-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"27256","name":"Presentation - Performance indicator questionnaire analysis 2010","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-23T02:00:00Z","last_updated_date":"2011-05-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-performance-indicator-questionnaire-analysis-2010_en.pdf"},
    {"id":"27259","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2003 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2003-08-01T02:00:00Z","last_updated_date":"2003-08-01T02:00:00Z","reference_number":"EMEA/CPMP/3754/03","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2003-plenary-meeting-monthly-report_en.pdf"},
    {"id":"27261","name":"Minutes of the joint European Medicines Agency / Food and Drug Administration workshop for paediatric Gaucher disease type I: exploring the way forward, 17-18 September 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-11-28T01:00:00Z","last_updated_date":"2012-11-28T01:00:00Z","reference_number":"EMA/610397/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-joint-european-medicines-agency-food-and-drug-administration-workshop-paediatric-gaucher-disease-type-i-exploring-way-forward-17-18-september-2012_en.pdf"},
    {"id":"27262","name":"Presentation - EMA workshop on adaptive pathways: PCWP and HCPWP contribution (Francesca Cerreta, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-workshop-adaptive-pathways-pcwp-and-hcpwp-contribution-francesca-cerreta-ema_en.pdf"},
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    {"id":"27266","name":"EU/3/14/1332: Public summary of opinion on orphan designation: Macromolecular conjugate of heparin sodium on a polymer backbone for the prevention of ischaemia/reperfusion injury associated with solid organ transplantati...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/452094/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141332-public-summary-opinion-orphan-designation-macromolecular-conjugate-heparin-sodium-polymer-backbone-prevention-ischaemiareperfusion-injury-associated-solid-organ-transplantati_en.pdf"},
    {"id":"27267","name":"Presentation - Adaptive Pathways: Can we build better links between decision makers? (Francesca Cerreta)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adaptive-pathways-can-we-build-better-links-between-decision-makers-francesca-cerreta_en.pdf"},
    {"id":"27268","name":"Questions and answers on Isotretinoin Ranbaxy (UK) Limited (isotretinoin 10 and 20 mg capsules)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"EMA/820119/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-isotretinoin-ranbaxy-uk-limited-isotretinoin-10-and-20-mg-capsules_sv.pdf"}},
    {"id":"27269","name":"Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0006","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-23T19:31:00Z","last_updated_date":"2017-02-23T19:31:00Z","reference_number":"EMA/101741/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproteroneethinylestradiol-prac-non-interventional-imposed-pass-final-study-report-assessment-report-emeahnpsrj0006_en.pdf"},
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    {"id":"27298","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel Mylan","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/379519/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-mylan_en.pdf"},
    {"id":"27299","name":"Presentation - Day 1: Advanced therapy in retinal and macular degeneration","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-1-advanced-therapy-retinal-and-macular-degeneration_en.pdf"},
    {"id":"27300","name":"Public statement on Hepacare (triple antigen hepatitis B recombinant vaccine) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-12-17T01:00:00Z","last_updated_date":"2002-12-17T01:00:00Z","reference_number":"EMEA/32933/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-hepacare-triple-antigen-hepatitis-b-recombinant-vaccine-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"27311","name":"Committee for medicinal products for veterinary use: Meeting of 12 to 14 October 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-10-15T14:39:21Z","last_updated_date":"2004-10-15T14:39:21Z","reference_number":"EMEA/CVMP/973/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-12-14-october-2004_en.pdf"},
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    {"id":"27316","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 19-20 November 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-12-12T11:45:00Z","last_updated_date":"2012-12-12T11:45:00Z","reference_number":"EMA/HMPC/768189/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-19-20-november-2012_en.pdf"},
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    {"id":"27326","name":"Presentation - Impact of Brexit on veterinary applications/marketing authorisations (Sandra Vanlievendael, Beyhan Mustafov, Andrei Spinei)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T02:00:00Z","last_updated_date":"2018-04-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-brexit-veterinary-applicationsmarketing-authorisations-sandra-vanlievendael-beyhan-mustafov-andrei-spinei_en.pdf"},
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    {"id":"27377","name":"Sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-11-01T17:36:25Z","reference_number":"EMA/CHMP/158934/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/sitagliptin-film-coated-tablets-25-50-and-100-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"27379","name":"Final European Union herbal monograph onEchinacea purpurea (L.) Moench, radix – Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-08-11T02:00:00Z","last_updated_date":"2017-08-11T02:00:00Z","reference_number":"EMA/HMPC/424583/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-onechinacea-purpurea-l-moench-radix-revision-1_en.pdf"},
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    {"id":"27386","name":"EU/3/14/1251: Public summary of opinion on orphan designation: Recombinant human alpha-glucosidase conjugated with multiple copies of synthetic bismannose-6-phosphate-tetra-mannose glycan for the treatment of glycogen st...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-06T02:00:00Z","last_updated_date":"2014-05-06T02:00:00Z","reference_number":"EMA/COMP/96508/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141251-public-summary-opinion-orphan-designation-recombinant-human-alpha-glucosidase-conjugated-multiple-copies-synthetic-bismannose-6-phosphate-tetra-mannose-glycan-treatment-glycogen-st_en.pdf"},
    {"id":"27387","name":"Presentation - The interface: Industry – CRO - Clinical trials networks (Andrew Rose, MCRN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interface-industry-cro-clinical-trials-networks-andrew-rose-mcrn_en.pdf"},
    {"id":"27388","name":"Superseded community herbal monograph on Sambucus nigra L., flos - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2018-06-27T02:09:21Z","reference_number":"EMEA/HMPC/283166/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-sambucus-nigra-l-flos-first-version_en.pdf"},
    {"id":"27390","name":"Draft list of references for assessment of: Juniperi fructus Juniperus communis L., fructus (Juniper berry)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-01-14T01:00:00Z","last_updated_date":"2009-01-14T01:00:00Z","reference_number":"EMEA/HMPC/442959/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-juniperi-fructus-juniperus-communis-l-fructus-juniper-berry_en.pdf"},
    {"id":"27392","name":"Questions and answers on the potential off-label use of celecoxib in patients with familial adenomatous polyposis","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/376406/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-potential-label-use-celecoxib-patients-familial-adenomatous-polyposis_en.pdf"},
    {"id":"27393","name":"Micotil 300 Injectie Article-34 referral - Annexes I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/micotil-300-injectie-article-34-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"27397","name":"EU/3/16/1824: Public summary of opinion on orphan designation: Pr-D-Cys-Met-Pip-Arg-Leu-Arg-Sar-Cys-Lys-Arg-Pro-Tyr-Tle-Leu-OH for the treatment of perinatal asphyxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/5833/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161824-public-summary-opinion-orphan-designation-pr-d-cys-met-pip-arg-leu-arg-sar-cys-lys-arg-pro-tyr-tle-leu-oh-treatment-perinatal-asphyxia_en.pdf"},
    {"id":"27398","name":"ICH Topic Q 5 C Quality of biotechnological products: Stability testing of biotechnological/biological products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1996-07-01T02:00:00Z","last_updated_date":"1996-07-01T02:00:00Z","reference_number":"CPMP/ICH/138/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-topic-q-5-c-quality-biotechnological-products-stability-testing-biotechnologicalbiological-products_en.pdf"},
    {"id":"27399","name":"Opinions on safety variations adopted during the July 2012 CHMP meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-25T14:10:00Z","last_updated_date":"2012-07-25T14:10:00Z","reference_number":"EMA/CHMP/410524/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-during-july-2012-chmp-meeting_en.pdf"},
    {"id":"27403","name":"Adenosine: List of nationally authorised medicinal products - PSUSA/00000062/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T12:30:00Z","last_updated_date":"2018-04-13T12:30:00Z","reference_number":"EMA/231148/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/adenosine-list-nationally-authorised-medicinal-products-psusa00000062201708_en.pdf"},
    {"id":"27409","name":"Magnesium sulfate: List of nationally authorised medicinal products - PSUSA/00009225/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-19T01:00:00Z","last_updated_date":"2016-10-18T10:40:10Z","reference_number":"EMA/143971/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-sulfate-list-nationally-authorised-medicinal-products-psusa00009225201506_en.pdf"},
    {"id":"27410","name":"Guideline on the development of medicinal products for the treatment of post-traumatic stress disorder (PTSD)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"CHMP/EWP/358650/2006 Corr 2*","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-medicinal-products-treatment-post-traumatic-stress-disorder-ptsd_en.pdf"},
    {"id":"27414","name":"Principles on the involvement of young patients/consumers within EMA activities","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-07-19T12:00:00Z","last_updated_date":"2017-07-19T12:00:00Z","reference_number":"EMA/494077/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/principles-involvement-young-patientsconsumers-within-ema-activities_en.pdf"},
    {"id":"27415","name":"Presentation - A modelling and simulation perspective on extrapolation (Ine Skottheim Rusten)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-perspective-extrapolation-ine-skottheim-rusten_en.pdf"},
    {"id":"27418","name":"Synulox Lactating Cow: Article 34 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-11-17T12:03:00Z","last_updated_date":"2011-11-17T12:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/synulox-lactating-cow-article-34-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"27419","name":"Presentation - Session 5: Approval of pembrolizumab (MSI-H/dMMR) and considerations for site-agnostic development of drugs in oncology (Steven Lemery)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-approval-pembrolizumab-msi-hdmmr-and-considerations-site-agnostic-development-drugs-oncology-steven-lemery_en.pdf"},
    {"id":"27421","name":"PRAC recommends restricting the use of flupirtine-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"EMA/362055/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-restricting-use-flupirtine-containing-medicines_en.pdf"},
    {"id":"27422","name":"Committee for Medicinal Products for Human Use (CHMP) - June 2008 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/CHMP/327265/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-june-2008-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"27428","name":"CHMP post-authorisation summary of positive opinion for Isentress","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/CHMP/373399/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-isentress_en.pdf-1"},
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    {"id":"27458","name":"Opinion following an Article 29(2) referral for Doxazosin Retard \"Arrow\" 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin: Background 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    {"id":"27538","name":"Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA (Paris, France)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-01-26T16:30:00Z","last_updated_date":"2017-01-26T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-icsrs-eea-paris-france_en.pdf"},
    {"id":"27540","name":"Committee for medicinal products for veterinary use: Meeting of 8 to 10 November 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-11-11T12:09:21Z","last_updated_date":"2005-11-11T12:09:21Z","reference_number":"EMEA/CVMP/360925/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-8-10-november-2005_en.pdf"},
    {"id":"27542","name":"European Union Telematics operations report: 33rd report for period ending 31 December 2011","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"EMA/185200/2012","document_url":"https://www.ema.europa.eu/en/documents/report/european-union-telematics-operations-report-33rd-report-period-ending-31-december-2011_en.pdf"},
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    {"id":"27556","name":"Incident management plan for medicines for veterinary use","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2004-02-11T01:00:00Z","last_updated_date":"2022-11-18T12:41:00Z","reference_number":"EMEA/711053/2010 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/other/incident-management-plan-medicines-veterinary-use_en.pdf"},
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    {"id":"27574","name":"EU/3/15/1438: Public summary of opinion on orphan designation: Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus ...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/COMP/55786/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151438-public-summary-opinion-orphan-designation-allogeneic-cd4-and-cd8-t-lymphocytes-ex-vivo-incubated-synthetic-peptides-viral-antigens-cytomegalovirus-adenovirus-and-epstein-barr-virus_en.pdf"},
    {"id":"27576","name":"EU/3/08/535: Public summary of positive opinion for orphan designation of humanised monoclonal antibody to the folate receptor alpha for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/48649/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308535-public-summary-positive-opinion-orphan-designation-humanised-monoclonal-antibody-folate-receptor-alpha-treatment-ovarian-cancer_en.pdf"},
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    {"id":"27579","name":"Neural stem cells: Prof Gianvito Martino, Division of Neuroscience San Raffaele Hospital, Italy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/neural-stem-cells-prof-gianvito-martino-division-neuroscience-san-raffaele-hospital-italy_en.pdf"},
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    {"id":"27597","name":"Alanine / arginine / aspartic acid / cysteine / glucose anhydrous / glutamic acid / glycine / histidine / isoleucine / leucine / lysine / methionine / olive oil refined / ornithine / phenylalanine / proline / serine / so...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-13T02:00:00Z","last_updated_date":"2016-10-17T17:40:00Z","reference_number":"EMA/607402/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/alanine-arginine-aspartic-acid-cysteine-glucose-anhydrous-glutamic-acid-glycine-histidine-isoleucine-leucine-lysine-methionine-olive-oil-refined-ornithine-phenylalanine-proline-serine-so_en.pdf-0"},
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    {"id":"27639","name":"Resistance against anti-microbial resistance: Veterinarians' goals and initiative - Jan Vaarten","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/resistance-against-anti-microbial-resistance-veterinarians-goals-and-initiative-jan-vaarten_en.pdf"},
    {"id":"27640","name":"Ketoprofen - Article 107 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoprofen-article-107-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ketoprofen-article-107-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ketoprofen-article-107-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ketoprofen-article-107-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ketoprofen-article-107-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ketoprofen-article-107-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ketoprofen-article-107-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ketoprofen-article-107-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ketoprofen-article-107-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ketoprofen-article-107-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ketoprofen-article-107-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ketoprofen-article-107-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ketoprofen-article-107-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ketoprofen-article-107-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ketoprofen-article-107-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ketoprofen-article-107-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ketoprofen-article-107-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ketoprofen-article-107-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ketoprofen-article-107-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ketoprofen-article-107-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ketoprofen-article-107-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ketoprofen-article-107-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/ketoprofen-article-107-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/ketoprofen-article-107-referral-annex-iii_no.pdf"}},
    {"id":"27643","name":"Information Technology Directors Group - Terms of reference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-23T14:55:00Z","last_updated_date":"2013-12-12T10:40:00Z","reference_number":"EMA/246934/2013","document_url":"https://www.ema.europa.eu/en/documents/other/information-technology-directors-group-terms-reference_en.pdf"},
    {"id":"27644","name":"Minutes of the seventh annual European network of paediatric research at the  European Medicines Agency (Enpr-EMA) coordinating group (CG) face to face meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-08-05T13:30:00Z","last_updated_date":"2015-08-05T13:30:00Z","reference_number":"EMA/367915/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-seventh-annual-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-cg-face-face-meeting_en.pdf"},
    {"id":"27645","name":"CHMP post-authorisation summary of positive opinion for Multaq","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/603654/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-multaq_en.pdf"},
    {"id":"27646","name":"Draft community list entry on Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-10-26T02:09:21Z","last_updated_date":"2006-10-26T02:09:21Z","reference_number":"EMEA/HMPC/428963/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-foeniculum-vulgare-miller-subsp-vulgare-var-dulce-miller-thellung-fructus_en.pdf"},
    {"id":"27647","name":"Outcome of written procedures during the period 13 September 2017 to 20 November 2017","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-12-15T17:00:00Z","last_updated_date":"2017-12-15T17:00:00Z","reference_number":"EMA/MB/771195/2017","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-written-procedures-during-period-13-september-2017-20-november-2017_en.pdf"},
    {"id":"27649","name":"CHMP post authorisation summary of positive opinion for Xelivia on 24 September 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/546145/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xelivia-24-september-2009_en.pdf"},
    {"id":"27650","name":"Early dialogue between regulators and health technology assessment bodies key to medicines development","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-28T01:00:00Z","last_updated_date":"2013-11-28T01:00:00Z","reference_number":"EMA/738272/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/early-dialogue-between-regulators-and-health-technology-assessment-bodies-key-medicines-development_en.pdf"},
    {"id":"27651","name":"Flugestone acetate: Summary report (2)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-03-01T01:00:00Z","last_updated_date":"2001-03-01T01:00:00Z","reference_number":"EMEA/MRL/780/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flugestone-acetate-summary-report-2_en.pdf"},
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    {"id":"27653","name":"EC - Switzerland MRA: Sectoral Annex on GMP medicinal products GMP inspection and batch certification","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-01-05T00:09:21Z","last_updated_date":"2010-01-05T00:09:21Z","reference_number":"EMA/825063/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ec-switzerland-mra-sectoral-annex-gmp-medicinal-products-gmp-inspection-and-batch-certification_en.pdf"},
    {"id":"27654","name":"Agenda - Expert meeting on paediatric development of fix-dose combinations for treatment of HIV","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-09-29T02:00:00Z","last_updated_date":"2015-09-29T02:00:00Z","reference_number":"EMA/589180/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-expert-meeting-paediatric-development-fix-dose-combinations-treatment-hiv_en.pdf"},
    {"id":"27655","name":"Retinoid Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/retinoid-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/retinoid-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/retinoid-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/retinoid-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/retinoid-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/retinoid-article-31-referral-annex-iv_et.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/retinoid-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/retinoid-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/retinoid-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/retinoid-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/retinoid-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/retinoid-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/retinoid-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/retinoid-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/retinoid-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/retinoid-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/retinoid-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/retinoid-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/retinoid-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/retinoid-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/retinoid-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"27657","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - The Patient's Perspective - Rodney Elgie","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-patients-perspective-rodney-elgie_en.pdf"},
    {"id":"27659","name":"European Medicines Agency Benefit-Risk methodology project - Description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2010-04-22T02:00:00Z","reference_number":"EMA/213482/2010","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-benefit-risk-methodology-project-description-current-practice-benefit-risk-assessment-centralised-procedure-products-eu-regulatory-network_en.pdf"},
    {"id":"27660","name":"Lovenox Article 30 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-22T18:30:00Z","last_updated_date":"2017-03-22T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lovenox-article-30-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lovenox-article-30-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lovenox-article-30-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lovenox-article-30-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lovenox-article-30-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lovenox-article-30-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lovenox-article-30-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lovenox-article-30-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lovenox-article-30-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/lovenox-article-30-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lovenox-article-30-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lovenox-article-30-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lovenox-article-30-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lovenox-article-30-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lovenox-article-30-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lovenox-article-30-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lovenox-article-30-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lovenox-article-30-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lovenox-article-30-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lovenox-article-30-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lovenox-article-30-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lovenox-article-30-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lovenox-article-30-referral-annex-iv_sv.pdf"}},
    {"id":"27662","name":"Iclusig Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-06T13:00:00Z","last_updated_date":"2014-07-11T19:00:00Z","reference_number":"EMA/PRAC/746118/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-timetable-procedure_en.pdf"},
    {"id":"27663","name":"Superseded list of references supporting the assessment report on: Calendulae flos Calendula officinalis L. (calendula flower) - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-03-06T00:09:21Z","last_updated_date":"2018-06-15T01:09:21Z","reference_number":"EMEA/HMPC/261882/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-calendulae-flos-calendula-officinalis-l-calendula-flower-first-version_en.pdf"},
    {"id":"27664","name":"European Medicines Agency reviews cardiovascular risk of Multaq","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-07-11T02:00:00Z","last_updated_date":"2011-07-11T02:00:00Z","reference_number":"EMA/CHMP/542840/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-reviews-cardiovascular-risk-multaq_en.pdf"},
    {"id":"27666","name":"Scientific recommendation on classification of advanced therapy medicinal products: viable genetically engineered ARPE-19 cells of human origin secreting glucose-binding fluorescent biosensor protein","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"EMA/272815/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-viable-genetically-engineered-arpe-19-cells-human-origin-secreting-glucose-binding-fluorescent-biosensor-protein_en.pdf"},
    {"id":"27667","name":"Highlights from the 5th EMA Industry platform meeting on the operation of EU pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"EMA/609257/2015","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-5th-ema-industry-platform-meeting-operation-eu-pharmacovigilance-legislation_en.pdf"},
    {"id":"27670","name":"Financial compensation for Member States’ participation in the linguistic checking of product related information","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-12-20T01:00:00Z","last_updated_date":"2012-12-20T01:00:00Z","reference_number":"EMA/MB/742965/2012","document_url":"https://www.ema.europa.eu/en/documents/other/financial-compensation-member-states-participation-linguistic-checking-product-related-information_en.pdf-0"},
    {"id":"27672","name":"Modified-release paracetamol-containing products to be suspended from EU market","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-12-15T01:00:00Z","last_updated_date":"2017-12-15T01:00:00Z","reference_number":"EMA/811872/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/modified-release-paracetamol-containing-products-be-suspended-eu-market_en.pdf"},
    {"id":"27673","name":"Work instructions for handling of renewals for centrally authorised veterinary medicinal products","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2016-07-20T16:30:00Z","last_updated_date":"2016-07-20T16:30:00Z","reference_number":"WIN/V/4030","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-handling-renewals-centrally-authorised-veterinary-medicinal-products_en.pdf"},
    {"id":"27674","name":"Supply and maintenance of plants and containers EMA/2013/12/IS –  Pre-qualification questionnaire for a restricted tender procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/supply-and-maintenance-plants-and-containers-ema201312is-pre-qualification-questionnaire-restricted-tender-procedure_en.doc"},
    {"id":"27675","name":"Presentation - Update on the list of Union reference dates and frequency of periodic-safety-update-report submission","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-list-union-reference-dates-and-frequency-periodic-safety-update-report-submission_en.pdf"},
    {"id":"27676","name":"Guideline on environmental risk assessments for medicinal products consisting of, or containing, genetically modified organisms (GMOs)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-12-11T01:00:00Z","last_updated_date":"2006-12-11T01:00:00Z","reference_number":"EMEA/CHMP/BWP/473191/2006 - Corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-environmental-risk-assessments-medicinal-products-consisting-or-containing-genetically-modified-organisms-gmos_en.pdf"},
    {"id":"27679","name":"CHMP confirms recommendations for use of Zydelig","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/488322/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/chmp-confirms-recommendations-use-zydelig_en.pdf"},
    {"id":"27680","name":"Cerdelga recommended for approval in type 1 Gaucher disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2014-11-21T13:00:00Z","reference_number":"EMA/709331/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/cerdelga-recommended-approval-type-1-gaucher-disease_en.pdf"},
    {"id":"27682","name":"Annual report on deferral granted in the paediatric investigation plan - (PED6) certified","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2000-06-19T02:00:00Z","last_updated_date":"2017-05-22T17:20:00Z","reference_number":"Version 1.0.6","document_url":"https://www.ema.europa.eu/en/documents/template-form/annual-report-deferral-granted-paediatric-investigation-plan-ped6-certified_en.pdf"},
    {"id":"27685","name":"Presentation - Community counts! CDC Public Health Surveillance for Bleeding Disorders (Mike Soucie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-community-counts-cdc-public-health-surveillance-bleeding-disorders-mike-soucie_en.pdf"},
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    {"id":"27688","name":"19th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-12-19T00:00:00Z","last_updated_date":"2001-12-19T00:00:00Z","reference_number":"EMEA/COMP/595/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/19th-meeting-committee-orphan-medicinal-products_en.pdf"},
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    {"id":"27783","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"EMA/CVMP/510960/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-12-14-july-2011_en.pdf"},
    {"id":"27784","name":"EU/3/14/1258: Public summary of opinion on orphan designation: Doxorubicin(6-maleimidocaproyl)hydrazone for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-07T02:00:00Z","last_updated_date":"2023-06-06T02:00:00Z","reference_number":"EMA/COMP/89615/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141258-public-summary-opinion-orphan-designation-doxorubicin6-maleimidocaproylhydrazone-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"27788","name":"EU/3/09/669: Public summary of positive opinion for orphan designation of low molecular weight dextran sulfate for the prevention of graft rejection during pancreatic islet transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2011-11-18T16:00:00Z","reference_number":"EMEA/COMP/439787/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309669-public-summary-positive-opinion-orphan-designation-low-molecular-weight-dextran-sulfate-prevention-graft-rejection-during-pancreatic-islet-transplantation_en.pdf"},
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    {"id":"27791","name":"Annex V - Service concession: Subcontractors (EMA/2016/43/RS)","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:30:00Z","last_updated_date":"2016-08-15T12:30:00Z","reference_number":"EMA/2016/43/RS","document_url":"https://www.ema.europa.eu/en/documents/procurement/annex-v-service-concession-subcontractors-ema201643rs_en.pdf"},
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    {"id":"27797","name":"CVMP summary of positive opinion for Clynav","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/CVMP/223807/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-clynav_en.pdf"},
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    {"id":"27799","name":"European database of suspected adverse drug reaction reports’ website (www.adrreports.eu): release notes v.1.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T18:30:00Z","last_updated_date":"2017-12-19T18:30:00Z","reference_number":"EMA/833629/2017","document_url":"https://www.ema.europa.eu/en/documents/other/european-database-suspected-adverse-drug-reaction-reports-website-wwwadrreportseu-release-notes-v10_en.pdf"},
    {"id":"27800","name":"EU/3/09/677 - Public summary of positive opinion for orphan designation of human tumour necrosis factor alpha-derived peptide Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-Ala-Lys-Pro-Trp-Tyr-Cys for the treatment of acute...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2009-10-20T02:00:00Z","reference_number":"EMEA/COMP/442408/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309677-public-summary-positive-opinion-orphan-designation-human-tumour-necrosis-factor-alpha-derived-peptide-cys-gly-gln-arg-glu-thr-pro-glu-gly-ala-glu-ala-lys-pro-trp-tyr-cys-treatment-acute_en.pdf"},
    {"id":"27801","name":"Presentation - SME workshop: Session 1: Statistical common types of clinical trial design, study objectives, randomisation and blinding, hypothesis testing, p-values and confidence intervals, sample size calculation (Dav...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-29T10:40:00Z","last_updated_date":"2016-02-29T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-workshop-session-1-statistical-common-types-clinical-trial-design-study-objectives-randomisation-and-blinding-hypothesis-testing-p-values-and-confidence-intervals-sample-size_en.pdf"},
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    {"id":"27806","name":"EU/3/14/1385: Public summary of positive opinion for orphan designation: Heat-killed Mycobacterium obuense (whole cell) for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/733185/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141385-public-summary-positive-opinion-orphan-designation-heat-killed-mycobacterium-obuense-whole-cell-treatment-pancreatic-cancer_en.pdf"},
    {"id":"27807","name":"Diclofenac (topical formulations): List of nationally authorised medicinal products - PSUSA/00010342/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T14:00:00Z","last_updated_date":"2016-10-17T20:37:49Z","reference_number":"EMA/446349/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/diclofenac-topical-formulations-list-nationally-authorised-medicinal-products-psusa00010342201509_en.pdf"},
    {"id":"27810","name":"Committee for Advanced Therapies (CAT): May 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-23T02:00:00Z","last_updated_date":"2011-05-23T02:00:00Z","reference_number":"EMA/CAT/393591/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-may-2011-meeting-monthly-report_en.pdf"},
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    {"id":"27813","name":"Guideline on data requirements for multistrain dossiers for inactivated vaccines against avian influenza, bluetongue and foot-and-mouth disease - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-03-18T01:00:00Z","last_updated_date":"2010-03-18T01:00:00Z","reference_number":"EMA/CVMP/IWP/105506/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-multistrain-dossiers-inactivated-vaccines-against-avian-influenza-bluetongue-and-foot-and-mouth-disease-first-version_en.pdf"},
    {"id":"27814","name":"Presentation - Brexit: implications for companies (Rick Clayton)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T02:00:00Z","last_updated_date":"2018-04-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-brexit-implications-companies-rick-clayton_en.pdf"},
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    {"id":"27821","name":"European Medicines Agency finalises new procedure for EU pharmaceutical guidelines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-06-30T02:00:00Z","last_updated_date":"2005-06-30T02:00:00Z","reference_number":"EMEA/216832/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-finalises-new-procedure-eu-pharmaceutical-guidelines_en.pdf"},
    {"id":"27822","name":"Programme of the European Medicines Agency (EMA)/European Generic medicines Association joint workshop on the impact of the revised EMA guideline on the pharmacokinetic and clinical evaluation of modified-release dosage ...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-03-16T14:30:00Z","last_updated_date":"2015-04-30T10:40:00Z","reference_number":"EMA/157739/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-european-medicines-agency-emaeuropean-generic-medicines-association-joint-workshop-impact-revised-ema-guideline-pharmacokinetic-and-clinical-evaluation-modified-release-dosage_en.pdf"},
    {"id":"27824","name":"Understanding the terminology used in pharmacogenetics","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-07-29T02:09:21Z","last_updated_date":"2004-07-29T02:09:21Z","reference_number":"EMEA/3842/04/Final","document_url":"https://www.ema.europa.eu/en/documents/other/understanding-terminology-used-pharmacogenetics_en.pdf"},
    {"id":"27825","name":"Policy on transparency and the handling of potential conflicts of interests of members of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and working groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-24T18:48:00Z","last_updated_date":"2016-03-14T17:00:00Z","reference_number":"EMA/421449/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/policy-transparency-and-handling-potential-conflicts-interests-members-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-working-groups_en.pdf"},
    {"id":"27826","name":"CVMP summary of positive opinion for Innovax-ND-IBD","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-06-16T02:00:00Z","last_updated_date":"2017-06-16T02:00:00Z","reference_number":"EMA/CVMP/290079/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-innovax-nd-ibd_en.pdf"},
    {"id":"27828","name":"Presentation - Impact on administrative burden and fees (Rose-Marie Molina)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-administrative-burden-and-fees-rose-marie-molina_en.pdf"},
    {"id":"27830","name":"Questions and answers on the withdrawal of the marketing application for Synordia","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-12-14T01:00:00Z","last_updated_date":"2006-12-14T01:00:00Z","reference_number":"EMEA/490683/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-synordia_sv.pdf"}},
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    {"id":"27833","name":"Communication by the European Medicines Agency on supply shortages of medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T00:00:00Z","last_updated_date":"2015-10-29T12:30:00Z","reference_number":"EMA/531390/2012","document_url":"https://www.ema.europa.eu/en/documents/other/communication-european-medicines-agency-supply-shortages-medicinal-products_en.pdf"},
    {"id":"27835","name":"Presentation - FranceCoag network (Roseline d'Oiron)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-francecoag-network-roseline-doiron_en.pdf"},
    {"id":"27837","name":"List of participants - Third stakeholders forum on the implementation of the new pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"EMA/822577/2011","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-third-stakeholders-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"27838","name":"Minutes - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-05-02T02:00:00Z","last_updated_date":"2017-05-02T02:00:00Z","reference_number":"EMA/186147/20177","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf-0"},
    {"id":"27839","name":"Bellis perennis: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/663/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bellis-perennis-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"27840","name":"EU/3/13/1156: Public summary of opinion on orphan designation: Recombinant human monoclonal antibody against hepatitis-B virus for the prevention of hepatitis-B re-infection following liver transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T17:30:00Z","last_updated_date":"2015-03-12T16:30:00Z","reference_number":"EMA/COMP/401189/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131156-public-summary-opinion-orphan-designation-recombinant-human-monoclonal-antibody-against-hepatitis-b-virus-prevention-hepatitis-b-re-infection-following-liver-transplantation_en.pdf"},
    {"id":"27843","name":"Flurbiprofen : List of nationally authorised medicinal products - PSUSA/00001450/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T11:39:00Z","last_updated_date":"2017-09-08T11:48:43Z","reference_number":"EMA/593212/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/flurbiprofen-list-nationally-authorised-medicinal-products-psusa00001450201611_en.pdf"},
    {"id":"27844","name":"Alcon Laboratories withdraws its application for RETAANE","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-02T01:00:00Z","last_updated_date":"2006-03-02T01:00:00Z","reference_number":"EMEA/76945/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/alcon-laboratories-withdraws-its-application-retaane_en.pdf"},
    {"id":"27845","name":"Tetrazepam-containing medicines - Article-107i procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-08T18:00:00Z","last_updated_date":"2013-05-08T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-annex-i_sv.pdf"}},
    {"id":"27846","name":"Annual report of the Good Clinical Practice Inspections Working Group 2011","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2012-07-17T12:20:00Z","last_updated_date":"2012-07-17T12:20:00Z","reference_number":"EMA/INS/GCP/972336/2011","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-good-clinical-practice-inspections-working-group-2011_en.pdf"},
    {"id":"27848","name":"Final community herbal monograph on Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-28T01:00:00Z","last_updated_date":"2011-01-28T01:00:00Z","reference_number":"EMA/HMPC/3203/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"27849","name":"Minutes of the 100th meeting of the Management Board: 6-7 June 2018","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2018-08-23T16:00:00Z","last_updated_date":"2018-08-23T16:00:00Z","reference_number":"EMA/MB/395034/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-100th-meeting-management-board-6-7-june-2018_en.pdf"},
    {"id":"27850","name":"Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-01-28T01:00:00Z","last_updated_date":"2011-06-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-and-veterinary-medicinal-products_en.pdf"},
    {"id":"27852","name":"Withdrawal letter: Cokiera","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-cokiera_en.pdf"},
    {"id":"27853","name":"EU/3/13/1192: Public summary of opinion on orphan designation:\n\nZoledronic acid for the treatment of complex regional pain syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2013-10-31T01:00:00Z","reference_number":"EMA/COMP/554682/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131192-public-summary-opinion-orphan-designation-zoledronic-acid-treatment-complex-regional-pain-syndrome_en.pdf"},
    {"id":"27855","name":"Septanest Article-30 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"EMA/443931/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/septanest-article-30-referral-notification_en.pdf"},
    {"id":"27857","name":"Overview of comments received on the draft public statement on the use of herbal medicinal products containing thujone","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-20T13:00:00Z","last_updated_date":"2012-06-29T14:12:00Z","reference_number":"EMA/HMPC/85696/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-public-statement-use-herbal-medicinal-products-containing-thujone_en.pdf"},
    {"id":"27858","name":"Presentation - Scientific advice throughout the life-cycle of the product (Spiros Vamvakas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advice-throughout-life-cycle-product-spiros-vamvakas_en.pdf"},
    {"id":"27861","name":"Presentation - Session 1: Use of real world data pre-authorisation – what can it answer? (Peter Mol)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-use-real-world-data-pre-authorisation-what-can-it-answer-peter-mol_en.pdf"},
    {"id":"27863","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 13-15 September 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-09-16T02:00:00Z","last_updated_date":"2011-09-16T02:00:00Z","reference_number":"EMA/CVMP/715220/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-13-15-september-2011_en.pdf"},
    {"id":"27864","name":"CHMP summary of positive opinion for Rezolsta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/CHMP/578742/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rezolsta_en.pdf"},
    {"id":"27867","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 10-13 October 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-10-20T19:10:00Z","last_updated_date":"2017-10-20T19:10:00Z","reference_number":"EMA/PDCO/692078/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-10-13-october-2017_en.pdf"},
    {"id":"27871","name":"Superseded list of references supporting the assessment report on: Hyperici herba, Hypericum perforatum L., herba (St. John’s wort)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-12-21T00:09:00Z","last_updated_date":"2023-02-22T00:09:00Z","reference_number":"EMA/HMPC/101620/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-hyperici-herba-hypericum-perforatum-l-herba-st-johns-wort_en.pdf"},
    {"id":"27872","name":"Benzydamine: List of nationally authorised medicinal products - PSUSA/00000375/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-05T02:00:00Z","last_updated_date":"2016-10-18T14:01:14Z","reference_number":"EMA/398898/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/benzydamine-list-nationally-authorised-medicinal-products-psusa00000375201510_en.pdf"},
    {"id":"27873","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2008 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-07-31T02:00:00Z","last_updated_date":"2008-07-31T02:00:00Z","reference_number":"EMEA/CHMP/390768/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2008-plenary-meeting-monthly-report_en.pdf"},
    {"id":"27874","name":"Overview of comments received on the draft Community herbal monograph on Echinacea angustifolia DC., radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2012-05-29T16:30:00Z","last_updated_date":"2012-05-29T16:30:00Z","reference_number":"EMA/HMPC/729132/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-draft-community-herbal-monograph-echinacea-angustifolia-dc-radix_en.pdf"},
    {"id":"27875","name":"EU/3/14/1301: Public summary of opinion on orphan designation: Humanised anti-alpha ν beta 6 monoclonal antibody for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T02:00:00Z","last_updated_date":"2014-09-01T02:00:00Z","reference_number":"EMA/COMP/374511/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141301-public-summary-opinion-orphan-designation-humanised-anti-alpha-i-12-beta-6-monoclonal-antibody-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"27876","name":"Type IB variations requiring linguistic review","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-21T02:00:00Z","last_updated_date":"2011-07-08T02:00:00Z","reference_number":"EMA/791081/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/type-ib-variations-requiring-linguistic-review_en.pdf"},
    {"id":"27880","name":"EudraVigilance release notes v.1.22","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-11-22T10:30:00Z","last_updated_date":"2019-11-04T12:30:00Z","reference_number":"EMA/257535/2019","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-release-notes-v122_en.pdf"},
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    {"id":"27931","name":"Annex D Draft Framework Services Contract Lots 1 5","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-01T02:00:00Z","last_updated_date":"2008-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-d-draft-framework-services-contract-lots-1-5_en.pdf"},
    {"id":"27934","name":"Antifibrinolytic medicines - Article-31 referral - Annex II (aprotinin)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-06T01:00:00Z","last_updated_date":"2013-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/antifibrinolytic-medicines-article-31-referral-annex-ii-aprotinin_sv.pdf"}},
    {"id":"27935","name":"Presentation - How should antibodies against monoclonal antibody therapeutics be assessed?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:45Z","last_updated_date":"2012-06-15T17:10:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-should-antibodies-against-monoclonal-antibody-therapeutics-be-assessed_en.pdf"},
    {"id":"27936","name":"Template for submission of a request for scientific support and advice on a traditional herbal medicinal product","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2005-10-24T02:00:00Z","last_updated_date":"2014-11-17T16:30:00Z","reference_number":"EMEA/HMPC/119889/2005 Rev. 1 Corr","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-submission-request-scientific-support-and-advice-traditional-herbal-medicinal-product_en.pdf"},
    {"id":"27937","name":"EU/3/17/1935: Public summary of opinion on orphan designation: 1,4-diamino-2,3-dicyano-1,4-bis[2-aminophenylthio]butadiene for the treatment of non-traumatic subarachnoid haemorrhage","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/COMP/685526/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171935-public-summary-opinion-orphan-designation-14-diamino-23-dicyano-14-bis2-aminophenylthiobutadiene-treatment-non-traumatic-subarachnoid-haemorrhage_en.pdf"},
    {"id":"27939","name":"Participants list - European Medicines Agency-EuropaBio information day","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-european-medicines-agency-europabio-information-day_en.pdf"},
    {"id":"27940","name":"CHMP post-authorisation summary of positive opinion for Eylea","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2015-01-23T01:00:00Z","reference_number":"EMA/CHMP/25641/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-eylea_en.pdf-1"},
    {"id":"27941","name":"EU/3/11/899: Public summary of opinion on orphan designation: 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid for the treatment of multiple myel...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMA/COMP/635488/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311899-public-summary-opinion-orphan-designation-22-2-1r-1-25-dichlorobenzoylaminoacetylamino-3-methylbutyl-5-oxo-132-dioxaborolane-44-diyldiacetic-acid-treatment-multiple-myel_en.pdf"},
    {"id":"27942","name":"37th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-07-31T02:00:00Z","last_updated_date":"2003-07-31T02:00:00Z","reference_number":"EMEA/COMP/1335/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/37th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"27944","name":"Adopted terms of reference (ToR) of the Telematics Change Management Board (CMB) and its key user groups","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2017-10-30T10:39:00Z","last_updated_date":"2017-10-30T10:39:00Z","reference_number":"EMA/620721/2017","document_url":"https://www.ema.europa.eu/en/documents/other/adopted-terms-reference-tor-telematics-change-management-board-cmb-and-its-key-user-groups_en.pdf"},
    {"id":"27945","name":"Pholcodine: List of nationally authorised medicinal products - PSUSA/00002396/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-02T11:00:00Z","last_updated_date":"2016-10-17T18:27:53Z","reference_number":"EMA/72990/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/pholcodine-list-nationally-authorised-medicinal-products-psusa00002396201505_en.pdf"},
    {"id":"27946","name":"Appendix for a 2nd step Notification (EMA)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-10-08T02:09:21Z","last_updated_date":"2009-10-08T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-2nd-step-notification-ema_en.doc"},
    {"id":"27947","name":"Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/709120/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks-chmp-endorses-prac-recommendation_en.pdf"},
    {"id":"27948","name":"Annex VI - Draft framework service contract for outsourcing - EMA/2012/21/IS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-12T09:50:00Z","last_updated_date":"2012-11-12T09:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-vi-draft-framework-service-contract-outsourcing-ema201221is_en.pdf"},
    {"id":"27951","name":"EU/3/09/632: Public summary of positive opinion for orphan designation\n\nof adeno-associated viral vector containing porphobilinogen deaminase gene\n\nfor the treatment of acute intermittent porphyria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-12T02:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"EMA/COMP/147330/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309632-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-containing-porphobilinogen-deaminase-gene-treatment-acute-intermittent-porphyria_en.pdf"},
    {"id":"27952","name":"CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats – Initial text","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag2-advice-european-medicines-agency-clinical-trial-advisory-group-clinical-trial-data-formats-initial-text_en.pdf"},
    {"id":"27953","name":"Final assessment report on Ononis spinosa L., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-05-28T02:00:00Z","last_updated_date":"2014-05-28T02:00:00Z","reference_number":"EMA/HMPC/138316/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-ononis-spinosa-l-radix_en.pdf"},
    {"id":"27954","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/CHMP/148113/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-5"},
    {"id":"27955","name":"Annex VII to procedure for conducting GCP inspections requested by the CHMP: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-05-28T02:00:00Z","last_updated_date":"2022-05-05T13:31:00Z","reference_number":"EMA/INS/GCP/188326/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-vii-procedure-conducting-gcp-inspections-requested-chmp-bioanalytical-part-pharmacokinetic-and-statistical-analyses-bioequivalence-trials_en.pdf"},
    {"id":"27957","name":"Declaration of research interests (addendum) - David Coghill","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-research-interests-addendum-david-coghill_en.pdf"},
    {"id":"27959","name":"Tobramycin VVB and associated names Article-29(4) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-i_sv.pdf"}},
    {"id":"27960","name":"CHMP summary of positive opinion for Ofev","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2014-11-21T13:00:00Z","reference_number":"EMA/CHMP/683189/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ofev_en.pdf"},
    {"id":"27961","name":"Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on stability and traceability requirements for vaccine intermediates","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2001-01-25T01:00:00Z","last_updated_date":"2001-01-25T01:00:00Z","reference_number":"CPMP/BWP/4310/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-proprietary-medicinal-products-cpmp-points-consider-stability-and-traceability-requirements-vaccine-intermediates_en.pdf"},
    {"id":"27962","name":"Draft list of references for assessment of: Vitis viniferae folium Vitis vinifera L. var. tinctoria, folium (red vine leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-12-21T00:09:21Z","last_updated_date":"2009-12-21T00:09:21Z","reference_number":"EMA/HMPC/16634/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-vitis-viniferae-folium-vitis-vinifera-l-var-tinctoria-folium-red-vine-leaf_en.pdf"},
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    {"id":"27983","name":"Final list of references supporting the public statement of Picrorhiza kurroa Royle ex Benth, radix","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2015-02-18T01:00:00Z","last_updated_date":"2015-02-18T01:00:00Z","reference_number":"EMA/HMPC/252875/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-public-statement-picrorhiza-kurroa-royle-ex-benth-radix_en.pdf"},
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    {"id":"27986","name":"Ropivacaine: List of nationally authorised medicinal products - PSUSA/00002662/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-22T15:41:00Z","last_updated_date":"2018-05-22T15:45:17Z","reference_number":"EMA/299649/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ropivacaine-list-nationally-authorised-medicinal-products-psusa00002662201709_en.pdf"},
    {"id":"27987","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - July 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-07-26T14:01:01Z","last_updated_date":"2012-07-26T14:01:01Z","reference_number":"EMA/CHMP/PhVWP/438980/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-july-2012_en.pdf"},
    {"id":"27989","name":"Presentation - Extrapolation for antiepileptic drugs (AED) in paediatrics (G. Pons, C. Chiron)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-antiepileptic-drugs-aed-paediatrics-g-pons-c-chiron_en.pdf"},
    {"id":"27990","name":"International Harmonisation of pharmacopoeial monographs - Michael Wierer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/international-harmonisation-pharmacopoeial-monographs-michael-wierer_en.pdf"},
    {"id":"27992","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the November 2010 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-11-12T01:00:00Z","last_updated_date":"2010-11-12T01:00:00Z","reference_number":"EMA/645806/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-november-2010-meeting_en.pdf"},
    {"id":"27993","name":"CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats - Final advice","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag2-advice-european-medicines-agency-clinical-trial-advisory-group-clinical-trial-data-formats-final-advice_en.pdf"},
    {"id":"27995","name":"Good practice guide on recording, coding, reporting and assessment of medication errors.","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-27T11:00:00Z","last_updated_date":"2015-11-27T11:00:00Z","reference_number":"EMA/762563/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-recording-coding-reporting-and-assessment-medication-errors_en.pdf"},
    {"id":"27996","name":"Draft guideline on the clinical investigation of human plasma derived factor VIII and IX products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"CPMP/BPWG/198/95 rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-human-plasma-derived-factor-viii-and-ix-products_en.pdf"},
    {"id":"27997","name":"EU/3/17/1863: Public summary of opinion on orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturati...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/208155/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171863-public-summary-opinion-orphan-designation-autologous-t-lymphocyte-enriched-population-cells-transduced-lentiviral-vector-encoding-chimeric-antigen-receptor-targeting-human-b-cell-maturati_en.pdf"},
    {"id":"27998","name":"Presentation - Implementation report on the patient safety recommendation 2009/C151/01 (Directorate General for Health and Consumers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-report-patient-safety-recommendation-2009c15101-directorate-general-health-and-consumers_en.pdf"},
    {"id":"28000","name":"Committee for veterinary medicinal products: Meeting of 14 to 16 October 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-10-17T14:39:21Z","last_updated_date":"2003-10-17T14:39:21Z","reference_number":"EMEA/CVMP/943/03/corrigendum","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-14-16-october-2003_en.pdf"},
    {"id":"28001","name":"Appendix 2 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP integrated inspection report","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-07-29T14:00:00Z","last_updated_date":"2017-05-15T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/appendix-2-ins-gcp-4-procedure-reporting-gcp-inspections-requested-chmp-gcp-integrated-inspection-report_en.pdf"},
    {"id":"28004","name":"Superseded assessment report on Linum usitatissimum L., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2006-10-25T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMEA/HMPC/167395/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-linum-usitatissimum-l-semen_en.pdf"},
    {"id":"28006","name":"Questions and answers on recommendation for refusal for a  change to the marketing authorisation  for  Tarceva","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2006-07-27T02:09:21Z","last_updated_date":"2006-07-27T02:09:21Z","reference_number":"EMEA/284207/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-change-marketing-authorisation-tarceva_en.pdf"},
    {"id":"28009","name":"Presentation - General principles of antiviral dose selection (Filip Josephson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-principles-antiviral-dose-selection-filip-josephson_en.pdf"},
    {"id":"28011","name":"CHMP post-authorisation summary of positive opinion for Nevanac","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T14:00:00Z","last_updated_date":"2016-06-24T14:00:00Z","reference_number":"EMA/CHMP/421658/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-nevanac_en.pdf-0"},
    {"id":"28013","name":"EU/3/06/427: Public summary of positive opinion for orphan designation of fenretinide for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2011-03-25T01:00:00Z","reference_number":"EMA/COMP/96616/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306427-public-summary-positive-opinion-orphan-designation-fenretinide-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"28014","name":"Scientific recommendation on classification of advanced therapy medicinal products: Viable chondrocytes cultured within a 3D hydrogel","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-25T18:00:00Z","last_updated_date":"2017-10-25T18:00:00Z","reference_number":"EMA/665239/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-viable-chondrocytes-cultured-within-3d-hydrogel_en.pdf"},
    {"id":"28016","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-03-18T14:50:00Z","last_updated_date":"2014-03-18T14:50:00Z","reference_number":"EMA/125456/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-february-2014_en.pdf"},
    {"id":"28017","name":"Agenda - European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) stakeholders annual meeting 2016","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T17:00:00Z","last_updated_date":"2016-03-30T17:00:00Z","reference_number":"EMA/852361/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-surveillance-veterinary-antimicrobial-consumption-esvac-stakeholders-annual-meeting-2016_en.pdf"},
    {"id":"28019","name":"Presentation - EMA monitoring sales of veterinary antimicrobial agents in Europe (Jan Vaarten)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-22T13:01:29Z","last_updated_date":"2010-12-22T13:01:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-monitoring-sales-veterinary-antimicrobial-agents-europe-jan-vaarten_en.pdf"},
    {"id":"28020","name":"EU/3/09/618: Public summary of positive opinion for orphan designation\n\nof allogeneic ex-vivo-expanded umbilical-cord blood cells for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-20T01:00:00Z","last_updated_date":"2015-05-08T02:00:00Z","reference_number":"EMEA/COMP/15535/2009 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309618-public-summary-positive-opinion-orphan-designation-allogeneic-ex-vivo-expanded-umbilical-cord-blood-cells-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"28022","name":"Presentation - Patients and healthcare professionals involvement in regulatory decisions - MPA (Jane Ahlqvist Rastad)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-and-healthcare-professionals-involvement-regulatory-decisions-mpa-jane-ahlqvist-rastad_en.pdf"},
    {"id":"28023","name":"Opinion of the Committee for CVMP on the establishment of maximum residue limits: Rafoxanide","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-05-03T19:00:00Z","last_updated_date":"2016-05-03T19:00:00Z","reference_number":"EMA/CVMP/705308/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-cvmp-establishment-maximum-residue-limits-rafoxanide_en.pdf"},
    {"id":"28025","name":"EU/3/02/112: Public summary of positive opinion for orphan designation of\n\ndoxorubicin carbon/iron magnetically targeted microparticles for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/2020/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302112-public-summary-positive-opinion-orphan-designation-doxorubicin-carboniron-magnetically-targeted-microparticles-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"28028","name":"Human medicines highlights - September 2013","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2013-10-04T16:50:00Z","last_updated_date":"2013-10-04T16:50:00Z","reference_number":"Issue 55","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-september-2013_en.pdf"},
    {"id":"28029","name":"COMP meeting report on the review of applications for orphan designation: May 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T17:40:00Z","last_updated_date":"2015-05-19T17:40:00Z","reference_number":"EMA/COMP/287101/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-may-2015_en.pdf"},
    {"id":"28030","name":"Final European Union herbal monograph on Ribes nigrum L., folium","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T10:03:00Z","last_updated_date":"2017-12-19T10:03:00Z","reference_number":"EMA/HMPC/745353/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-ribes-nigrum-l-folium_en.pdf"},
    {"id":"28031","name":"Presentation - The new outcome measures in MS: possible better ways to assess disability that overcome the limitations of the EDSS (Gilmore O'Neill)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-outcome-measures-ms-possible-better-ways-assess-disability-overcome-limitations-edss-gilmore-oneill_en.pdf"},
    {"id":"28032","name":"Opinion following an Article 6(12) referral Avelox and associated names International Non-Proprietary Name (INN): moxifloxacin: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-08-14T02:08:21Z","last_updated_date":"2008-08-14T02:08:21Z","reference_number":"EMEA/CHMP/524251/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-612-referral-avelox-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sv.pdf"}},
    {"id":"28035","name":"Presentation - Measuring concentrations of Rivaroxaban, Apixaban, Edoxaban: methods and challenges (Steve Kitchen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-measuring-concentrations-rivaroxaban-apixaban-edoxaban-methods-and-challenges-steve-kitchen_en.pdf"},
    {"id":"28036","name":"Good-manufacturing-practice inspection report - Community format","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2006-09-20T02:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMEA/INS/GMP/313539/2006","document_url":"https://www.ema.europa.eu/en/documents/template-form/good-manufacturing-practice-inspection-report-community-format_en.doc"},
    {"id":"28038","name":"Start of community reviews - CHMP meeting of 21-24 October 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T15:00:00Z","last_updated_date":"2013-10-25T15:00:00Z","reference_number":"EMA/647670/2013","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-21-24-october-2013_en.pdf"},
    {"id":"28040","name":"Draft list of references supporting the assessment of Leonurus cardiaca L., herba\n\nLeonuri cardiacae herba, \n\n(motherwort)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2010-05-26T02:00:00Z","last_updated_date":"2010-05-26T02:00:00Z","reference_number":"EMA/HMPC/127429/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-leonurus-cardiaca-l-herba-leonuri-cardiacae-herba-motherwort_en.pdf"},
    {"id":"28041","name":"EU/3/16/1790: Public summary of positive opinion for orphan designation of Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Gly-Gly-Asp-Leu-Leu-Pro-Arg-Gly-Ser for the treatment of Huntington’s disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T12:46:00Z","last_updated_date":"2016-12-14T12:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161790-public-summary-positive-opinion-orphan-designation-tyr-gly-arg-lys-lys-arg-arg-gln-arg-arg-gly-gly-asp-leu-leu-pro-arg-gly-ser-treatment-huntingtons-disease_en.pdf"},
    {"id":"28048","name":"Supply shortage of Fabrazyme – updated treatment recommendations required for adult male patients","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/602583/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/supply-shortage-fabrazyme-updated-treatment-recommendations-required-adult-male-patients_en.pdf"},
    {"id":"28050","name":"Note for guidance on the clinical Investigation of Recombinant Factor VIII and IX Products - Superseded","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-10-19T02:00:00Z","last_updated_date":"2000-10-19T02:00:00Z","reference_number":"CPMP/BPWG/1561/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-recombinant-factor-viii-and-ix-products-superseded_en.pdf"},
    {"id":"28051","name":"Annual report 2011 (Annexes)","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-06T18:11:03Z","last_updated_date":"2012-06-06T18:11:03Z","reference_number":"EMA/363033/2012","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-2011-annexes_en.pdf"},
    {"id":"28052","name":"European Medicines Agency and FDA announce launch of generic medicines application inspections initiative","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-18T01:00:00Z","last_updated_date":"2013-12-18T01:00:00Z","reference_number":"EMA/797904/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-fda-announce-launch-generic-medicines-application-inspections-initiative_en.pdf"},
    {"id":"28053","name":"CHMP post-authorisation summary of positive opinion for RoActemra (II/57)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/420471/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-roactemra-ii57_en.pdf"},
    {"id":"28054","name":"Draft list of references supporting the assessment of\n\nArctostaphylos uva-ursi (L.) Spreng., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2017-04-12T14:08:00Z","last_updated_date":"2017-04-12T14:08:00Z","reference_number":"EMA/HMPC/750270/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-arctostaphylos-uva-ursi-l-spreng-folium_en.pdf"},
    {"id":"28055","name":"EU/3/00/011: Public summary of positive opinion for orphan designation of busulfan (intravenous use) for the conditioning treatment prior to haematopoietic-progenitor-cell transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2013-07-31T02:00:00Z","reference_number":"EMEA/COMP/243537/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300011-public-summary-positive-opinion-orphan-designation-busulfan-intravenous-use-conditioning-treatment-prior-haematopoietic-progenitor-cell-transplantation_en.pdf"},
    {"id":"28057","name":"EU/3/13/1114: Public summary of opinion on orphan designation: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] aceta...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-04-08T12:50:00Z","last_updated_date":"2013-04-08T12:50:00Z","reference_number":"EMA/COMP/105652/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131114-public-summary-opinion-orphan-designation-cyclol-alanyl-l-seryl-l-isoleucyl-l-prolyl-l-prolyl-l-glutaminyl-l-lysyl-l-tyrosyl-d-prolyl-l-prolyl-2s-2-aminodecanoyl-l-alpha-glutamyl-l-threonyl_en.pdf"},
    {"id":"28058","name":"Public statement on authorisation of bluetongue vaccines","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T18:45:00Z","last_updated_date":"2013-06-07T18:45:00Z","reference_number":"EMA/CVMP/37133/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-authorisation-bluetongue-vaccines_en.pdf"},
    {"id":"28060","name":"European Medicines Agency’s Management Board endorses work programme 2011 and launches new Road Map to 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/834513/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-endorses-work-programme-2011-and-launches-new-road-map-2015_en.pdf"},
    {"id":"28061","name":"New advanced therapy to repair cartilage defects in the knee","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T14:00:03Z","last_updated_date":"2017-05-19T14:00:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-advanced-therapy-repair-cartilage-defects-knee_en.pdf"},
    {"id":"28062","name":"Initial notices for parallel distribution - 2010","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-09-26T13:20:00Z","last_updated_date":"2011-09-26T13:20:00Z","reference_number":"EMA/742250/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2010_en.pdf"},
    {"id":"28063","name":"Report on the European Medicines Agency workshop of pharmacovigilance in the paediatric population","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-08-28T11:35:00Z","last_updated_date":"2014-08-28T11:35:00Z","reference_number":"EMA/288486/2014","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-medicines-agency-workshop-pharmacovigilance-paediatric-population_en.pdf"},
    {"id":"28064","name":"Commitee for Orphan Medicinal Products: October 2004 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-10-08T02:00:00Z","last_updated_date":"2004-10-08T02:00:00Z","reference_number":"EMEA/COMP/101411/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/commitee-orphan-medicinal-products-october-2004-meeting_en.pdf"},
    {"id":"28066","name":"Presentation - Advanced cell models, organs on a chip and\n\nmicrophysiological systems in drug development (A. Roth)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T10:54:00Z","last_updated_date":"2017-11-15T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-advanced-cell-models-organs-chip-and-microphysiological-systems-drug-development-roth_en.pdf"},
    {"id":"28068","name":"Principles for ensuring the confidentiality of data supplied to the European Surveillance of Veterinary Antimicrobial Agent Consumption (ESVAC) project","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-24T01:00:00Z","last_updated_date":"2016-08-10T18:50:00Z","reference_number":"EMA/327935/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/principles-ensuring-confidentiality-data-supplied-european-surveillance-veterinary-antimicrobial-agent-consumption-esvac-project_en.pdf"},
    {"id":"28070","name":"Cefapirin: Summary report  (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-02-01T01:00:00Z","last_updated_date":"2001-02-01T01:00:00Z","reference_number":"EMEA/MRL/745/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefapirin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28071","name":"Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-02-11T10:40:00Z","last_updated_date":"2016-02-11T10:40:00Z","reference_number":"EMA/CHMP/BPWP/144533/2009 rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-viii-products-revision-1_en.pdf"},
    {"id":"28072","name":"Draft guideline on risk assessment of medicinal products on human Reproduction and lactation: from data to labelling","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-03-23T01:00:00Z","last_updated_date":"2006-03-23T01:00:00Z","reference_number":"EMEA/CHMP/203927/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-risk-assessment-medicinal-products-human-reproduction-and-lactation-data-labelling_en.pdf"},
    {"id":"28074","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Rydapt (midostaurin) for the treatment of acute myeloid leukaemia and mastocytosis","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T02:00:00Z","last_updated_date":"2017-10-25T02:00:00Z","reference_number":"EMA/550601/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-rydapt-midostaurin-treatment-acute-myeloid-leukaemia-and-mastocytosis_en.pdf"},
    {"id":"28075","name":"Public statement on Ioa: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-08-26T02:00:00Z","last_updated_date":"2014-08-26T02:00:00Z","reference_number":"EMA/477726/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ioa-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"28077","name":"Day 120 list of questions - generics template rev. 10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-07-08T15:20:00Z","last_updated_date":"2016-10-03T13:30:00Z","reference_number":"Rev. 3.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/day-120-list-questions-generics-template-rev-1016_en.doc"},
    {"id":"28078","name":"Presentation - Good pharmacovigilance practices module II: Pharmacovigilance system master file","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-03T17:30:00Z","last_updated_date":"2012-05-03T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file_en.pdf"},
    {"id":"28080","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 March 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-04-09T15:41:00Z","last_updated_date":"2018-04-09T15:41:00Z","reference_number":"EMA/PDCO/203743/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-20-23-march-2018_en.pdf"},
    {"id":"28084","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hamamelis virginiana L., cortex","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"EMEA/HMPC/582862/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-hamamelis-virginiana-l-cortex_en.pdf"},
    {"id":"28086","name":"Presentation - Take-home messages (Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-13T01:00:00Z","last_updated_date":"2017-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-take-home-messages-juan-garcia-burgos_en.pdf"},
    {"id":"28089","name":"Declaration of interests: Achilleas Voutsas","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T11:23:38Z","last_updated_date":"2016-09-08T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-achilleas-voutsas_en.pdf"},
    {"id":"28091","name":"Committee for medicinal products for human use summary of positive opinion for Exforge HCT","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:09:21Z","last_updated_date":"2009-07-23T02:09:21Z","reference_number":"EMEA/CHMP/450701/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-exforge-hct_en.pdf"},
    {"id":"28092","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Athens","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-athens_en.pdf-0"},
    {"id":"28093","name":"CHMP post-authorisation summary of positive opinion for Baraclude","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-07-25T02:00:00Z","last_updated_date":"2014-07-25T02:00:00Z","reference_number":"EMA/CHMP/425704/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-baraclude_en.pdf-0"},
    {"id":"28094","name":"Diplomatic notes exchanged on completion of the preparatory work 28 April 2004: Japan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-04-28T02:00:00Z","last_updated_date":"2004-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/diplomatic-notes-exchanged-completion-preparatory-work-28-april-2004-japan_en.pdf"},
    {"id":"28095","name":"Public statement on Gonazon: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-08-15T12:20:00Z","last_updated_date":"2012-08-15T12:20:00Z","reference_number":"EMA/537200/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-gonazon-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"28096","name":"Pathogen specific database: Covernote","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-covernote_en.pdf"},
    {"id":"28097","name":"EU/3/16/1631: Public summary of opinion on orphan designation: Florilglutamic acid (18F) for the diagnosis of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2016-05-02T02:00:00Z","reference_number":"EMA/COMP/172323/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161631-public-summary-opinion-orphan-designation-florilglutamic-acid-18f-diagnosis-glioma_en.pdf"},
    {"id":"28098","name":"Zinbryta Article-20 referral - Annex IV - Scientific conclusions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-19T18:23:00Z","last_updated_date":"2017-07-19T18:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinbryta-article-20-referral-annex-iv-scientific-conclusions_sv.pdf"}},
    {"id":"28099","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2009 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-30T02:00:00Z","last_updated_date":"2009-07-30T02:00:00Z","reference_number":"EMEA/CHMP/473955/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2009-plenary-meeting-monthly-report_en.pdf"},
    {"id":"28100","name":"Opinions on safety variations adopted at the CHMP meeting 27-30 May 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T13:00:00Z","last_updated_date":"2013-06-07T13:00:00Z","reference_number":"EMA/CHMP/184573/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-chmp-meeting-27-30-may-2013_en.pdf"},
    {"id":"28101","name":"CHMP summary of positive opinion for Signifor","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T01:00:00Z","last_updated_date":"2012-01-20T01:00:00Z","reference_number":"EMA/34679/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-signifor_en.pdf"},
    {"id":"28103","name":"Calcium carbonate / famotidine / magnesium hydroxide: List of nationally authorised medicinal products - PSUSA/00001351/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-12T02:00:00Z","last_updated_date":"2016-10-18T15:41:09Z","reference_number":"EMA/544237/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-carbonate-famotidine-magnesium-hydroxide-list-nationally-authorised-medicinal-products-psusa00001351201409_en.pdf"},
    {"id":"28104","name":"Domperidone Article-31 referral - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-11T02:00:00Z","last_updated_date":"2014-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/domperidone-article-31-referral-cmdh-divergent-position_en.pdf"},
    {"id":"28105","name":"European Medicines Agency makes recommendations for safer use of Ritalin and other methylphenidate-containing medicines in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T00:09:21Z","last_updated_date":"2009-01-23T00:09:21Z","reference_number":"EMEA/22315/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-makes-recommendations-safer-use-ritalin-and-other-methylphenidate-containing-medicines-eu_en.pdf"},
    {"id":"28106","name":"Amisulpride: List of nationally authorised medicinal products - PSUSA/00000167/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-05T12:10:00Z","last_updated_date":"2017-10-05T12:10:00Z","reference_number":"EMA/658194/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/amisulpride-list-nationally-authorised-medicinal-products-psusa00000167201701_en.pdf"},
    {"id":"28107","name":"Environmental risk-assessment of medicines","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2013-03-25T11:30:00Z","last_updated_date":"2015-05-18T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/environmental-risk-assessment-medicines_en.pdf"},
    {"id":"28109","name":"Organisational matters - CHMP meeting 20-23 April 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T17:10:00Z","last_updated_date":"2015-04-29T17:10:00Z","reference_number":"EMA/28003/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-20-23-april-2015_en.pdf"},
    {"id":"28112","name":"Almitrine Article-31 - Oral almitrine to be withdrawn by EU Member States","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T12:00:00Z","last_updated_date":"2013-05-31T12:00:00Z","reference_number":"EMA/313994/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/almitrine-article-31-oral-almitrine-be-withdrawn-eu-member-states_sv.pdf"}},
    {"id":"28113","name":"Organisational matters, CHMP meeting 12-15 December 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-16T16:15:00Z","last_updated_date":"2011-12-16T16:15:00Z","reference_number":"EMA/CHMP/941889/2011","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-12-15-december-2011_en.pdf"},
    {"id":"28114","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the December 2010 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2011-11-22T16:48:00Z","reference_number":"EMA/773028/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-december-2010-meeting_en.pdf"},
    {"id":"28115","name":"EU/3/15/1596: Public summary of opinion on orphan designation: Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts for the treatment of partial deep dermal and full ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2016-02-03T01:00:00Z","reference_number":"EMA/COMP/796203/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151596-public-summary-opinion-orphan-designation-bilayer-engineered-collagen-hydrogel-based-skin-graft-composed-autologous-keratinocytes-and-fibroblasts-treatment-partial-deep-dermal-and-full_en.pdf"},
    {"id":"28116","name":"EMEA launches Eudra Vigilance training programme","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-04-01T02:00:00Z","last_updated_date":"2004-04-01T02:00:00Z","reference_number":"EMEA/9254/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-launches-eudra-vigilance-training-programme_en.pdf"},
    {"id":"28118","name":"Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis B","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"EMA/824717/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/direct-acting-antivirals-hepatitis-c-ema-confirms-recommendation-screen-hepatitis-b_en.pdf"},
    {"id":"28119","name":"European Medicines Agency 2011 priorities for drug safety research: Gadolinium-containing contrast agents and nephrogenic systemic fibrosis: long-term consequences of retention in human skin and bone","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-07-08T02:00:00Z","last_updated_date":"2010-07-26T02:00:00Z","reference_number":"EMA/425304/2010","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-2011-priorities-drug-safety-research-gadolinium-containing-contrast-agents-and-nephrogenic-systemic-fibrosis-long-term-consequences-retention-human-skin-and-bone_en.pdf"},
    {"id":"28121","name":"CHMP summary of positive opinion for Duloxetine Zentiva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/CHMP/431635/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-duloxetine-zentiva_en.pdf"},
    {"id":"28122","name":"EU/3/06/366: Public summary of positive opinion for orphan designation of tobramycin (liposomal) for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2013-03-14T11:00:00Z","reference_number":"EMEA/COMP/105966/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306366-public-summary-positive-opinion-orphan-designation-tobramycin-liposomal-treatment-pseudomonas-aeruginosa-lung-infection-cystic-fibrosis_en.pdf"},
    {"id":"28126","name":"Work programme for the European Agency for the Evaluation of Medicinal Products 2002","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2002-04-02T02:09:21Z","last_updated_date":"2002-04-02T02:09:21Z","reference_number":"EMEA/MB/049/01-EN-Final","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_es.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_de.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2002_sv.pdf"}},
    {"id":"28127","name":"Presentation - EU network pharmacovigilance governance (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-network-pharmacovigilance-governance-peter-arlett_en.pdf"},
    {"id":"28129","name":"CHMP summary of positive opinion for Lidocaine/Prilocaine Plethora","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/488493/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lidocaineprilocaine-plethora_en.pdf"},
    {"id":"28134","name":"Committee for Medicinal Products for Human Use (CHMP) - March 2006 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-04-06T02:00:00Z","last_updated_date":"2006-04-06T02:00:00Z","reference_number":"CHMP/102937/2006, Rev 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-march-2006-plenary-meeting-monthly-report_en.pdf"},
    {"id":"28139","name":"Draft community herbal monograph on Urtica dioica L. and Urtica urens L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-09-07T02:00:00Z","last_updated_date":"2007-09-07T02:00:00Z","reference_number":"EMEA/HMPC/170261/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-urtica-dioica-l-and-urtica-urens-l-herba_en.pdf"},
    {"id":"28140","name":"Superseded overview of comments received on 'community herbal monograph on Valeriana officinalis L., radix' EMEA/HMPC/340719/2005 (Valerianae aetheroleum)","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2016-06-20T02:00:00Z","last_updated_date":"2016-06-20T02:00:00Z","reference_number":"EMEA/HMPC/50774/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-valeriana-officinalis-l-radix-emeahmpc3407192005-valerianae-aetheroleum_en.pdf"},
    {"id":"28141","name":"European Medicines Agency’s Management Board endorses revised policy on handling of declarations of interests","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-24T13:00:00Z","last_updated_date":"2014-03-24T13:00:00Z","reference_number":"EMA/170855/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-endorses-revised-policy-handling-declarations-interests_en.pdf"},
    {"id":"28142","name":"EU/3/18/2003: Public summary of opinion on orphan designation: Ribavirin for the treatment of Lassa fever","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-15T02:00:00Z","last_updated_date":"2018-05-15T02:00:00Z","reference_number":"EMA/132080/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182003-public-summary-opinion-orphan-designation-ribavirin-treatment-lassa-fever_en.pdf"},
    {"id":"28143","name":"EU/3/10/830: Public summary of opinion on orphan designation: Veliparib for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2013-03-14T11:00:00Z","reference_number":"EMA/COMP/668370/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310830-public-summary-opinion-orphan-designation-veliparib-treatment-ovarian-cancer_en.pdf"},
    {"id":"28145","name":"Presentation - Elemental impurity risk assessment: case studies (Andrew Teasdale, Laura Rutter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-elemental-impurity-risk-assessment-case-studies-andrew-teasdale-laura-rutter_en.pdf"},
    {"id":"28146","name":"EU/3/08/566: Public summary of positive opinion for orphan designation of levofloxacin hemihydrate for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2018-02-09T01:00:00Z","reference_number":"EMEA/COMP/450243/2008 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308566-public-summary-positive-opinion-orphan-designation-levofloxacin-hemihydrate-treatment-cystic-fibrosis_en.pdf"},
    {"id":"28147","name":"Methylphenidate Hexal Article-29 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-12-05T01:00:00Z","last_updated_date":"2013-12-05T01:00:00Z","reference_number":"EMA/596773/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/methylphenidate-hexal-article-29-referral-assessment-report_en.pdf"},
    {"id":"28148","name":"Questions and answers on the review of Rotarix (rotavirus vaccine, live)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/CHMP/460465/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-rotarix-rotavirus-vaccine-live_en.pdf"},
    {"id":"28150","name":"Draft assessment report on Juglans regia L., folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-01-25T01:00:00Z","last_updated_date":"2013-01-25T01:00:00Z","reference_number":"EMA/HMPC/346740/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-juglans-regia-l-folium_en.pdf"},
    {"id":"28153","name":"Intravenous iron-containing medicinal products Article-31 referral: New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/377372/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-new-recommendations-manage-risk-allergic-reactions-intravenous-iron-containing-medicines_en.pdf-0"},
    {"id":"28155","name":"CHMP summary of positive opinion for Modigraf","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-03-19T01:00:00Z","last_updated_date":"2009-03-19T01:00:00Z","reference_number":"EMEA/CHMP/127261/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-modigraf_en.pdf"},
    {"id":"28156","name":"EU/3/11/938: Public summary of positive opinion for orphan designation: Adeno-associated viral vector containing the human factor IX gene for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2013-03-11T13:30:00Z","reference_number":"EMA/COMP/911845/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311938-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-factor-ix-gene-treatment-haemophilia-b_en.pdf"},
    {"id":"28157","name":"Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines (EMEA/CPMP/BWP/2758/02) - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-06-17T02:00:00Z","last_updated_date":"2009-06-17T02:00:00Z","reference_number":"EMEA/CHMP/BWP/290688/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-pharmaceutical-aspects-product-information-human-vaccines-emeacpmpbwp275802-revision-1_en.pdf"},
    {"id":"28158","name":"Presentation - Statisticians perspectives on extrapolation (D. Wright)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-statisticians-perspectives-extrapolation-d-wright_en.pdf"},
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    {"id":"28210","name":"Work Instructions for EudraVigilance medicinal product dictionary: population with approved substances - type vaccines","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-07-10T02:00:00Z","last_updated_date":"2010-10-01T02:00:00Z","reference_number":"WIN/H/3302","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-eudravigilance-medicinal-product-dictionary-population-approved-substances-type-vaccines_en.pdf"},
    {"id":"28213","name":"Invitation for expressions of interest - European Medicines Agency workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-20T16:40:00Z","last_updated_date":"2013-06-20T16:40:00Z","reference_number":"EMA/346872/2013","document_url":"https://www.ema.europa.eu/en/documents/other/invitation-expressions-interest-european-medicines-agency-workshop-clinical-investigation-new-medicines-treatment-multiple-sclerosis_en.pdf"},
    {"id":"28215","name":"Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T13:00:00Z","last_updated_date":"2017-07-10T13:00:00Z","reference_number":"EMA/435940/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/clevidipine-list-nationally-authorised-medicinal-products-psusa00010288201611_en.pdf"},
    {"id":"28216","name":"Trichlormethiazide: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-04-01T02:00:00Z","last_updated_date":"1999-04-01T02:00:00Z","reference_number":"EMEA/MRL/515/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/trichlormethiazide-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28218","name":"SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-02-12T13:00:00Z","last_updated_date":"2016-02-12T13:00:00Z","reference_number":"EMA/100751/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/sglt2-inhibitors-prac-makes-recommendations-minimise-risk-diabetic-ketoacidosis_en.pdf"},
    {"id":"28219","name":"New EMA guidance on development of antibacterials to help in the fight against multidrug-resistant pathogens","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-07T11:35:00Z","last_updated_date":"2013-11-07T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-ema-guidance-development-antibacterials-help-fight-against-multidrug-resistant-pathogens_en.pdf"},
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    {"id":"28222","name":"VICH GL41: Target animal safety: Examination of live veterinary vaccines in target animals for absence of reversion to virulence - At step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-18T02:00:00Z","last_updated_date":"2007-09-18T02:00:00Z","reference_number":"EMEA/CVMP/VICH/1052/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl41-target-animal-safety-examination-live-veterinary-vaccines-target-animals-absence-reversion-virulence-step-7_en.pdf"},
    {"id":"28224","name":"Presentation - SME workshop: Session 3: Statistical considerations in confirmatory clinical trials I (Norbert Benda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-29T10:40:00Z","last_updated_date":"2016-02-29T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-workshop-session-3-statistical-considerations-confirmatory-clinical-trials-i-norbert-benda_en.pdf"},
    {"id":"28227","name":"Towards Quality by Design: Modelling Nano-Particles & their Formulation in Relation to Product Physical Properties - Kevin J Roberts","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-29T02:09:21Z","last_updated_date":"2009-04-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/towards-quality-design-modelling-nano-particles-their-formulation-relation-product-physical-properties-kevin-j-roberts_en.pdf"},
    {"id":"28228","name":"European Medicines Agency appoints senior medical officer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-11-08T01:00:00Z","last_updated_date":"2006-11-08T01:00:00Z","reference_number":"EMEA/405691/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-appoints-senior-medical-officer_en.pdf"},
    {"id":"28229","name":"Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-09-21T16:45:00Z","last_updated_date":"2012-09-21T16:45:00Z","reference_number":"EMA/483755/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-medicines-which-studies-have-been-conducted-texas-based-cetero-research-facility_en.pdf"},
    {"id":"28232","name":"Herbal medicinal producta: New Committee & European dimension, 23 September 2004 - Dagmar Roth-Behrendt","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-09-27T02:09:21Z","last_updated_date":"2004-09-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/herbal-medicinal-producta-new-committee-european-dimension-23-september-2004-dagmar-roth-behrendt_en.pdf"},
    {"id":"28233","name":"Moxonidine : List of nationally authorised medicinal products -  PSUSA/00002095/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T18:35:00Z","last_updated_date":"2017-10-03T18:37:17Z","reference_number":"EMA/652910/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/moxonidine-list-nationally-authorised-medicinal-products-psusa00002095201701_en.pdf"},
    {"id":"28234","name":"Demonstration of Relevance of the Animal Model - B. Silva Lima","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-06-15T02:09:21Z","last_updated_date":"2007-06-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/demonstration-relevance-animal-model-b-silva-lima_en.pdf"},
    {"id":"28236","name":"Presentation - Open discussion","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-open-discussion_en.pdf"},
    {"id":"28237","name":"Agenda - Training session for patients and consumers interested in European Medicines Agency activities","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T16:00:00Z","last_updated_date":"2016-02-01T15:00:00Z","reference_number":"EMA/654468/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-patients-and-consumers-interested-european-medicines-agency-activities_en.pdf"},
    {"id":"28238","name":"Committee for medicinal products for human use, summary of positive opinion for Mycophenolate","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-01-14T01:00:00Z","last_updated_date":"2008-01-14T01:00:00Z","reference_number":"EMEA/CHMP/563031/2007, corr","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-mycophenolate_en.pdf"},
    {"id":"28239","name":"CHMP post-authorisation summary of positive opinion for Relvar Ellipta (WS-1208)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-01-26T10:12:00Z","last_updated_date":"2018-01-26T10:12:00Z","reference_number":"EMA/CHMP/12287/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-relvar-ellipta-ws-1208_en.pdf"},
    {"id":"28240","name":"EU/3/09/671: Public summary of positive opinion for orphan designation of pasireotide for the treatment of Cushing’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2022-06-14T01:00:00Z","reference_number":"EMEA/COMP/455317/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309671-public-summary-positive-opinion-orphan-designation-pasireotide-treatment-cushings-disease_en.pdf"},
    {"id":"28241","name":"Overview of comments received on the guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus (CPMP/EWP/1080/00 Rev. 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-31T15:35:00Z","last_updated_date":"2012-07-31T15:35:00Z","reference_number":"EMA/444348/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-diabetes-mellitus-cpmpewp108000-rev-1_en.pdf"},
    {"id":"28243","name":"Presentation - PD targets for various infection types: Stasis vs. 1-Log Kill vs. 2 Log Kill (George Drusano)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pd-targets-various-infection-types-stasis-vs-1-log-kill-vs-2-log-kill-george-drusano_en.pdf"},
    {"id":"28247","name":"Registration form - 2013 European Medicines Agency / International Federation for Animal Health Europe info day","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-01-24T16:00:01Z","last_updated_date":"2013-01-24T16:00:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-2013-european-medicines-agency-international-federation-animal-health-europe-info-day_en.doc"},
    {"id":"28248","name":"Sanofi Pasteur withdraws its marketing authorisation application for Emerflu, pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-06T01:00:00Z","last_updated_date":"2010-12-06T01:00:00Z","reference_number":"EMA/776824/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/sanofi-pasteur-withdraws-its-marketing-authorisation-application-emerflu-pandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted_en.pdf"},
    {"id":"28250","name":"Ciprofloxacin hydrochloride, dexamethasone acetate (ear drops, suspension): List of nationally authorised medicinal products - PSUSA/00010012/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-30T14:00:00Z","last_updated_date":"2016-10-17T20:25:30Z","reference_number":"EMA/648833/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciprofloxacin-hydrochloride-dexamethasone-acetate-ear-drops-suspension-list-nationally-authorised-medicinal-products-psusa00010012201504_en.pdf"},
    {"id":"28252","name":"EU/3/18/2037: Public summary of opinion on orphan designation: Omaveloxolone for treatment of Friedreich's ataxia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-22T12:01:00Z","last_updated_date":"2018-08-22T12:01:00Z","reference_number":"EMA/395368/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182037-public-summary-opinion-orphan-designation-omaveloxolone-treatment-friedreichs-ataxia_en.pdf"},
    {"id":"28253","name":"CHMP post-authorisation summary of positive opinion for Zonegran","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/336696/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zonegran_en.pdf"},
    {"id":"28254","name":"EU/3/09/718: Public summary of opinion on orphan designation of fingolimod for the treatment of chronic inflammatory demyelinating polyneuropathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T14:43:00Z","last_updated_date":"2017-02-07T14:43:00Z","reference_number":"EMA/COMP/831319/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309718-public-summary-opinion-orphan-designation-fingolimod-treatment-chronic-inflammatory-demyelinating-polyneuropathy_en.pdf"},
    {"id":"28255","name":"Questions and answers on the positive opinion on the marketing authorisation for Defitelio (defibrotide) - Outcome of re-examination","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/457737/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-positive-opinion-marketing-authorisation-defitelio-defibrotide-outcome-re-examination_en.pdf"},
    {"id":"28256","name":"Pseudoephedrine, triprolidine: List of nationally authorised medicinal products -PSUSA/00003047/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-17T12:00:00Z","last_updated_date":"2016-10-17T19:05:45Z","reference_number":"EMA/619753/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/pseudoephedrine-triprolidine-list-nationally-authorised-medicinal-products-psusa00003047201412_en.pdf"},
    {"id":"28257","name":"Presentation - Day 2: Ocular surface biomarkers and inflammation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-ocular-surface-biomarkers-and-inflammation_en.pdf"},
    {"id":"28259","name":"EU/3/03/139: Public summary of positive opinion for orphan designation of bosentan for treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2014-05-08T18:00:00Z","reference_number":"EMEA/COMP/270/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303139-public-summary-positive-opinion-orphan-designation-bosentan-treatment-systemic-sclerosis_en.pdf"},
    {"id":"28261","name":"Committee for medicinal products for human use, post-authorisation summary of positive opinion for Januvia on 15 November 2007","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2007-12-20T01:00:00Z","last_updated_date":"2007-12-20T01:00:00Z","reference_number":"EMEA/CHMP/531209/2007","document_url":"https://www.ema.europa.eu/en/documents/smop/committee-medicinal-products-human-use-post-authorisation-summary-positive-opinion-januvia-15-november-2007_en.pdf"},
    {"id":"28262","name":"Presentation - Diabetes and endocrinology European research network (David Dunger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-diabetes-and-endocrinology-european-research-network-david-dunger_en.pdf"},
    {"id":"28264","name":"CVMP summary of positive opinion for Dany's BienenWohl","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-04-20T17:08:00Z","last_updated_date":"2018-04-20T17:08:00Z","reference_number":"EMA/CVMP/178553/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-danys-bienenwohl_en.pdf"},
    {"id":"28265","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  Mylotarg : International non-proprietary name (INN): gemtuzumab ozogamicin","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-09-20T02:09:21Z","last_updated_date":"2007-09-20T02:09:21Z","reference_number":"EMEA/318553/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-mylotarg-international-non-proprietary-name-inn-gemtuzumab-ozogamicin_en.pdf"},
    {"id":"28266","name":"Overview of comments received on 'Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-09-14T18:20:00Z","last_updated_date":"2015-09-14T18:20:00Z","reference_number":"EMA/CHMP/407380/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-evaluation-medicinal-products-treatment-chronic-constipation-including-opioid-induced-constipation-and-bowel-cleansing_en.pdf"},
    {"id":"28267","name":"Presentation - The Joint Programming Initiative: translate research into policy and regulation (Herman Goossens)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-programming-initiative-translate-research-policy-and-regulation-herman-goossens_en.pdf"},
    {"id":"28269","name":"Presentation - Diagnosing PML, Joseph Berger","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-diagnosing-pml-joseph-berger_en.pdf"},
    {"id":"28270","name":"Presentation - Holistic approach to paediatric research: industry perspective (T. Tillmann, L.R. Arfelt, M. Dehlinger-Kremer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:00:00Z","last_updated_date":"2018-06-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-industry-perspective-t-tillmann-lr-arfelt-m-dehlinger-kremer_en.pdf"},
    {"id":"28271","name":"Points to consider on the development of live attenuated influenza vaccines - Superseded","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-02-20T01:00:00Z","last_updated_date":"2003-02-20T01:00:00Z","reference_number":"EMEA/CPMP/BWP/2289/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-development-live-attenuated-influenza-vaccines-superseded_en.pdf"},
    {"id":"28272","name":"Paediatric Committee (PDCO) workplan 2016","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T20:40:00Z","last_updated_date":"2015-07-06T20:40:00Z","reference_number":"EMA/PDCO/605931/2016","document_url":"https://www.ema.europa.eu/en/documents/work-programme/paediatric-committee-pdco-workplan-2016_en.pdf"},
    {"id":"28273","name":"Presentation - Framework on the interaction between the European Medicines Agency and healthcare professionals (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-framework-interaction-between-european-medicines-agency-and-healthcare-professionals-ivana-silva_en.pdf"},
    {"id":"28274","name":"Questions and answers on the withdrawal of the marketing authorisation application for Neocepri (folic acid)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-06-17T02:00:00Z","last_updated_date":"2015-01-12T14:30:00Z","reference_number":"EMA/303644/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-neocepri-folic-acid_en.pdf"},
    {"id":"28275","name":"Withdrawal assessment report for Advexin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-09-10T02:00:00Z","last_updated_date":"2009-09-10T02:00:00Z","reference_number":"EMEA/692328/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-advexin_en.pdf"},
    {"id":"28276","name":"EU/3/09/661: Public summary of positive opinion for orphan designation: (S)-ethyl 2-amino-3-(4-(2-amino-6(-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate for the tr...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/142686/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309661-public-summary-positive-opinion-orphan-designation-s-ethyl-2-amino-3-4-2-amino-6-1-4-chloro-2-3-methyl-1h-pyrazol-1-ylphenyl-222-trifluoroethoxypyrimidin-4-ylphenylpropanoate-tr_en.pdf"},
    {"id":"28277","name":"Presentation - Intestinal Pseudo-obstruction (Gut Motility Disorders) (Nikhil Thapar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-intestinal-pseudo-obstruction-gut-motility-disorders-nikhil-thapar_en.pdf"},
    {"id":"28278","name":"Meprobamate - Article 107 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-06-08T16:15:00Z","last_updated_date":"2012-06-08T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/meprobamate-article-107-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/meprobamate-article-107-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/meprobamate-article-107-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/meprobamate-article-107-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/meprobamate-article-107-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/meprobamate-article-107-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/meprobamate-article-107-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/meprobamate-article-107-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/meprobamate-article-107-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/meprobamate-article-107-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/meprobamate-article-107-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/meprobamate-article-107-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/meprobamate-article-107-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/meprobamate-article-107-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/meprobamate-article-107-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/meprobamate-article-107-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/meprobamate-article-107-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/meprobamate-article-107-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/meprobamate-article-107-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/meprobamate-article-107-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/meprobamate-article-107-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/meprobamate-article-107-referral-annex-i_sv.pdf"}},
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    {"id":"28280","name":"EU/3/06/410: Public summary of positive opinion for orphan designation of\n\ndoxorubicin hydrochloride (liposomal) for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/41533/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306410-public-summary-positive-opinion-orphan-designation-doxorubicin-hydrochloride-liposomal-treatment-soft-tissue-sarcoma_en.pdf"},
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    {"id":"28287","name":"Guideline on epidemiological data on blood transmissible infections","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-10-12T02:00:00Z","last_updated_date":"2010-10-12T02:00:00Z","reference_number":"EMA/CHMP/BWP/548524/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-epidemiological-data-blood-transmissible-infections_en.pdf"},
    {"id":"28288","name":"EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety (RONAFA)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-01-24T10:59:01Z","last_updated_date":"2017-01-24T10:59:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/ema-and-efsa-joint-scientific-opinion-measures-reduce-need-use-antimicrobial-agents-animal-husbandry-european-union-and-resulting-impacts-food-safety-ronafa_en.pdf"},
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    {"id":"28290","name":"EU/3/12/1024: Public summary of opinion on orphan designation: Metreleptin for the treatment of Lawrence syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-08-31T12:30:00Z","last_updated_date":"2015-05-13T12:30:00Z","reference_number":"EMA/COMP/440579/2012 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121024-public-summary-opinion-orphan-designation-metreleptin-treatment-lawrence-syndrome_en.pdf"},
    {"id":"28291","name":"EU/3/13/1230: Public summary of opinion on orphan designation: (2R,3R,4S,5R)-2-(6-amino-9H-purin-9-yl)-5-((((1r,3S)-3-(2-(5-(tert-butyl)-1H-benzo[d]imidazol-2-yl)ethyl)cyclobutyl)(isopropyl) amino)methyl)tetrahydrofuran-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2014-03-24T01:00:00Z","reference_number":"EMA/COMP/5578/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131230-public-summary-opinion-orphan-designation-2r3r4s5r-2-6-amino-9h-purin-9-yl-5-1r3s-3-2-5-tert-butyl-1h-benzodimidazol-2-ylethylcyclobutylisopropyl-aminomethyltetrahydrofuran_en.pdf"},
    {"id":"28292","name":"Draft guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species/limited markets - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2009-03-16T01:00:00Z","reference_number":"EMEA/CVMP/IWP/123243/2006-Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-immunological-veterinary-medicinal-products-intended-minor-use-or-minor-specieslimited-markets-revision-2_en.pdf"},
    {"id":"28294","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 19 – 22 March 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2018-03-26T18:07:00Z","last_updated_date":"2018-03-26T18:07:00Z","reference_number":"EMA/CHMP/SAWP/195437/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-19-22-march-2018_en.pdf"},
    {"id":"28296","name":"Standard operating procedure for Processing of parallel distribution initial notifications","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-07-19T13:00:00Z","last_updated_date":"2012-07-19T13:00:00Z","reference_number":"SOP/INSP/2014","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-processing-parallel-distribution-initial-notifications_en.pdf"},
    {"id":"28298","name":"Summary of Product Characteristics Advisory Group (SmPC AG) 6-year activity report (2016)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T13:59:00Z","last_updated_date":"2017-03-27T13:59:00Z","reference_number":"EMA/151145/2017","document_url":"https://www.ema.europa.eu/en/documents/report/summary-product-characteristics-advisory-group-smpc-ag-6-year-activity-report-2016_en.pdf"},
    {"id":"28299","name":"Task Force for the implementation of International Standards on Identification of Medicinal Products in the EU (i.e. EU IDMP/SPOR Task Force)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-09-20T13:39:00Z","last_updated_date":"2016-09-20T13:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/task-force-implementation-international-standards-identification-medicinal-products-eu-ie-eu-idmpspor-task-force_en.pdf"},
    {"id":"28302","name":"Analysis and assessment of the 2009 annual activity report of the Executive Director","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2010-06-18T02:00:00Z","reference_number":"EMA/MB/297535/2010","document_url":"https://www.ema.europa.eu/en/documents/report/analysis-and-assessment-2009-annual-activity-report-executive-director_en.pdf"},
    {"id":"28304","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2007","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-11-24T00:09:21Z","last_updated_date":"2009-11-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2007_en.pdf"},
    {"id":"28305","name":"Opinion of the HMPC on a European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/HMPC/469777/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"28306","name":"Presentation - Day 1: Dry AMD - the regulatory view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-1-dry-amd-regulatory-view_en.pdf"},
    {"id":"28307","name":"CHMP post-authorisation summary of positive opinion for Tamiflu","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-03-27T01:00:00Z","last_updated_date":"2015-03-27T01:00:00Z","reference_number":"EMA/186701/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tamiflu_en.pdf"},
    {"id":"28308","name":"Workshop on medicines in bees - Break-out session briefing document","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-medicines-bees-break-out-session-briefing-document_en.pdf"},
    {"id":"28310","name":"Opinion following a referral for arbitration according to Article 7(5) of Commission Regulation (EC) No 541/95 as amended, for Bifril/Teoula/Zofepril/Zopranol International Non-Proprietary Name (INN): zofenopril: Backgro...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2000-12-16T00:08:21Z","last_updated_date":"2000-12-16T00:08:21Z","reference_number":"CPMP/4362/00","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-referral-arbitration-according-article-75-commission-regulation-ec-no-54195-amended-bifrilteoulazofeprilzopranol-international-non-proprietary-name-inn-zofenopril-backgro_en.pdf"},
    {"id":"28312","name":"Presentation - Data exclusivity, market protection and paediatric rewards (Zaide Frias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-exclusivity-market-protection-and-paediatric-rewards-zaide-frias_en.pdf"},
    {"id":"28313","name":"Presentation - European Network for Health Technology Assessment joint action 2 work programme 7: Multi-health-technology-assessment early dialogues (Mira Pavlovic, Francois Meyer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T01:00:00Z","last_updated_date":"2013-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-health-technology-assessment-joint-action-2-work-programme-7-multi-health-technology-assessment-early-dialogues-mira-pavlovic-francois-meyer_en.pdf"},
    {"id":"28314","name":"Honey bee diseases in France, Marie-Pierre Chauzat, Agence Franà§aise de Sà©curità© Sanitaire des Produits de Santà©","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/honey-bee-diseases-france-marie-pierre-chauzat-agence-franassaise-de-saccuritac-sanitaire-des-produits-de-santac_en.pdf"},
    {"id":"28316","name":"Colchicine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-10T01:00:00Z","last_updated_date":"1997-02-10T01:00:00Z","reference_number":"EMEA/MRL/044/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/colchicine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28318","name":"Presentation - Process validation: Enhanced approach scale down models (Frank Zettl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-process-validation-enhanced-approach-scale-down-models-frank-zettl_en.pdf"},
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    {"id":"28364","name":"EU/3/15/1606: Public summary of opinion on orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate for the treatment of s...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2019-10-24T01:00:00Z","reference_number":"EMA/COMP/844899/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151606-public-summary-opinion-orphan-designation-s-n-5-r-2-25-difluorophenylpyrrolidin-1-ylpyrazolo15-apyrimidin-3-yl-3-hydroxypyrrolidine-1-carboxamide-hydrogen-sulfate-treatment-s_en.pdf"},
    {"id":"28365","name":"Meloxicam: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-02-01T01:00:00Z","last_updated_date":"1999-02-01T01:00:00Z","reference_number":"EMEA/MRL/571/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/meloxicam-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28366","name":"Opinion following an Article 33 referral for Combisyn Lactating Cow and associated names: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-12-08T01:00:00Z","last_updated_date":"2011-12-08T01:00:00Z","reference_number":"EMEA/V/A/063","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-33-referral-combisyn-lactating-cow-and-associated-names-background-information_sv.pdf"}},
    {"id":"28368","name":"Beclometasone: List of nationally authorised medicinal products - PSUSA/00000306/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T16:00:00Z","last_updated_date":"2017-09-08T16:00:00Z","reference_number":"EMA/594294/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/beclometasone-list-nationally-authorised-medicinal-products-psusa00000306201612_en.pdf"},
    {"id":"28369","name":"CHMP summary of opinion for Docetaxel Hospira UK Limited","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2019-10-15T02:00:00Z","reference_number":"EMA/CHMP/289487/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-docetaxel-hospira-uk-limited_en.pdf"},
    {"id":"28370","name":"EU/3/01/082: Public summary of positive opinion for orphan designation \n\nof 2-chloro-9-[2-deoxy-2-fluoro-àŸ-D-arabinofuranosyl]adenine for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2016-08-10T02:00:00Z","reference_number":"EMEA/COMP/66/02 Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301082-public-summary-positive-opinion-orphan-designation-2-chloro-9-2-deoxy-2-fluoro-ay-d-arabinofuranosyladenine-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"28371","name":"Public statement on Docefrez: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2012-06-14T02:00:00Z","last_updated_date":"2012-06-14T02:00:00Z","reference_number":"EMA/394526/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-docefrez-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"28374","name":"Retinoid Article-31 referral - Updated measures for pregnancy prevention during retinoid use","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/165360/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-updated-measures-pregnancy-prevention-during-retinoid-use_en.pdf-0"},
    {"id":"28379","name":"Divergent position regarding the referral for arbitration under Article 33 of Directive 2001/82/EC submitted for Bovimec B and Porcimec P","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2014-08-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-regarding-referral-arbitration-under-article-33-directive-200182ec-submitted-bovimec-b-and-porcimec-p_en.pdf"},
    {"id":"28380","name":"Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-08-13T15:00:00Z","last_updated_date":"2018-08-13T15:00:00Z","reference_number":"EMA/CHMP/BPWP/1619/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-human-plasma-derived-and-recombinant-coagulation-factor-viii-products-revision-3_en.pdf"},
    {"id":"28381","name":"Questions and answers on Amoxil and associated names (amoxicillin)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"EMA/421017/2015 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-amoxil-and-associated-names-amoxicillin_sv.pdf"}},
    {"id":"28382","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 13-16 February 2012","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T13:00:00Z","last_updated_date":"2012-02-17T13:00:00Z","reference_number":"EMA/CHMP/SAWP/114282/2012","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-13-16-february-2012_en.pdf"},
    {"id":"28383","name":"EU/3/08/528: Public summary of positive opinion for orphan designation of lumiliximab for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/36761/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308528-public-summary-positive-opinion-orphan-designation-lumiliximab-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"28384","name":"Presentation: Applied ethics & societal aspects in applied human\n\npharmacology","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-08-20T02:00:00Z","last_updated_date":"2010-08-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-applied-ethics-societal-aspects-applied-human-pharmacology_en.pdf"},
    {"id":"28387","name":"EU/3/16/1769: Public summary of positive opinion for orphan designation of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde for the treatment of sickle cell disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T15:43:00Z","last_updated_date":"2016-12-14T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161769-public-summary-positive-opinion-orphan-designation-2-hydroxy-6-2-1-isopropyl-1h-pyrazol-5-ylpyridin-3-ylmethoxybenzaldehyde-treatment-sickle-cell-disease_en.pdf"},
    {"id":"28388","name":"Focus Group meeting on Bioequivalence - IFAH-Europe topics for discussion","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-06T02:09:21Z","last_updated_date":"2009-05-06T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/focus-group-meeting-bioequivalence-ifah-europe-topics-discussion_en.pdf"},
    {"id":"28390","name":"Superseded opinion of the Committee on Herbal Medicinal products on a community herbal monograph for Linum usitatissimum L., semen","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-07-13T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"EMEA/HMPC/353205/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-linum-usitatissimum-l-semen_en.pdf"},
    {"id":"28391","name":"Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2014-06-25T14:00:00Z","last_updated_date":"2023-06-26T16:32:00Z","reference_number":"EMA/344487/2014 Corr.8","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-ix-list-combined-hormonal-contraceptives-containing-chlormadinone-european-union_en.xlsx"},
    {"id":"28392","name":"Presentation - Module 4 - Advanced therapy medicinal products (ATMPs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T02:00:00Z","last_updated_date":"2018-09-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-module-4-advanced-therapy-medicinal-products-atmps_en.pdf"},
    {"id":"28395","name":"Opinion following an Article 30 referral for Gemzar and associated names International Non-Proprietary Name (INN): gemcitabine: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-09-24T02:08:21Z","last_updated_date":"2008-09-24T02:08:21Z","reference_number":"EMEA/CHMP/512295/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-30-referral-gemzar-and-associated-names-international-non-proprietary-name-inn-gemcitabine-background-information_sv.pdf"}},
    {"id":"28398","name":"Presentation: Copa-Cogeca’s views on Critically Important Antibiotics (CIA) (Miguel Angel Higuera)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-copa-cogecas-views-critically-important-antibiotics-cia-miguel-angel-higuera_en.pdf"},
    {"id":"28399","name":"Presentation - Advanced-therapy medicinal product (ATMP) development challenges: From scientific advice to market authorisation (Peter McArdle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-04T01:00:00Z","last_updated_date":"2015-11-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-advanced-therapy-medicinal-product-atmp-development-challenges-scientific-advice-market-authorisation-peter-mcardle_en.pdf"},
    {"id":"28400","name":"Assessment of the paediatric needs - Immunology","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-09-01T02:00:00Z","last_updated_date":"2006-09-01T02:00:00Z","reference_number":"EMEA/381922/2006","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-immunology_en.pdf"},
    {"id":"28402","name":"Committee for medicinal products for human use, summary of positive opinion for Renvela","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-03-19T01:00:00Z","last_updated_date":"2009-03-19T01:00:00Z","reference_number":"EMEA/CHMP/175954/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-renvela_en.pdf"},
    {"id":"28403","name":"Human coagulation factor VII: List of nationally authorised medicinal products - PSUSA/00001619/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T14:30:00Z","last_updated_date":"2017-07-10T14:30:00Z","reference_number":"EMA/437790/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-coagulation-factor-vii-list-nationally-authorised-medicinal-products-psusa00001619201610_en.pdf"},
    {"id":"28404","name":"Baxter dialysis solutions Article-31 referral - Annex I (3 sites)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-3-sites_sv.pdf"}},
    {"id":"28405","name":"Presentation - Paediatric investigation plans for medicines to treat high-grade glioma","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-06T02:00:00Z","last_updated_date":"2011-07-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-investigation-plans-medicines-treat-high-grade-glioma_en.pdf"},
    {"id":"28406","name":"Guideline on core SmPC and package leaflet for sodium fluoride (18F)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-07-20T16:45:00Z","last_updated_date":"2015-07-20T16:45:00Z","reference_number":"EMA/212874/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-and-package-leaflet-sodium-fluoride-18f_en.pdf"},
    {"id":"28407","name":"Public statement on the interpretation of the term 'external use' for use in the field of traditional herbal medicinal products","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2006-05-12T02:00:00Z","last_updated_date":"2006-05-12T02:00:00Z","reference_number":"EMEA/HMPC/31897/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-interpretation-term-external-use-use-field-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"28409","name":"CHMP ORGAM agenda for the meeting on 12 February 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-03-09T16:30:00Z","last_updated_date":"2018-03-09T16:30:00Z","reference_number":"EMA/CHMP/91430/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-12-february-2018_en.pdf"},
    {"id":"28410","name":"Union procedure on sharing of pharmacovigilance inspection information","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-06-20T12:15:00Z","last_updated_date":"2014-06-20T12:15:00Z","reference_number":"EMA/INS/PhV/192233/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/union-procedure-sharing-pharmacovigilance-inspection-information_en.pdf"},
    {"id":"28411","name":"Standard operating procedure for handling of requests for ADR-related EudraVigilance data","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T10:53:00Z","last_updated_date":"2019-01-07T10:53:00Z","reference_number":"SOP/H/3326","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-handling-requests-adr-related-eudravigilance-data_en.pdf"},
    {"id":"28412","name":"Nifedipine: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00002156/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-07T02:00:00Z","last_updated_date":"2016-10-18T12:37:32Z","reference_number":"EMA/394060/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/nifedipine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002156201508_en.pdf"},
    {"id":"28416","name":"Presentation - Safety communication and its role in risk minimisation (June M Raine, Juan Garcia-Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-safety-communication-and-its-role-risk-minimisation-june-m-raine-juan-garcia-burgos_en.pdf"},
    {"id":"28417","name":"Guidance on format of the risk-management plan in the European Union (EU) part II: Module SVI - Additional EU requirements for the safety specification","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2012-11-08T18:00:00Z","reference_number":"EMA/714655/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-eu-part-ii-module-svi-additional-eu-requirements-safety-specification_en.pdf"},
    {"id":"28418","name":"Nafcillin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-01-01T01:00:00Z","last_updated_date":"1997-01-01T01:00:00Z","reference_number":"EMEA/MRL/147/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/nafcillin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28419","name":"Nicorandil: List of nationally authorised medicinal products - PSUSA/00002152/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T15:00:00Z","last_updated_date":"2016-10-28T15:00:00Z","reference_number":"EMA/692015/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/nicorandil-list-nationally-authorised-medicinal-products-psusa00002152201602_en.pdf"},
    {"id":"28422","name":"Agenda - Programme - European Medicines Agency workshop on multiplicity issues in clinical trials","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-10-18T10:52:00Z","last_updated_date":"2012-10-18T10:52:00Z","reference_number":"EMA/519224/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-european-medicines-agency-workshop-multiplicity-issues-clinical-trials_en.pdf"},
    {"id":"28424","name":"Inhaled corticosteroids Article-31 referral – PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-03-18T01:00:00Z","reference_number":"EMA/197713/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/inhaled-corticosteroids-article-31-referral-prac-reviews-known-risk-pneumonia-inhaled-corticosteroids-chronic-obstructive-pulmonary-disease_en.pdf"},
    {"id":"28429","name":"Invitation - Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-19T02:00:00Z","last_updated_date":"2014-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/invitation-committee-advanced-therapies-cat-and-german-society-transfusion-medicine-and-immunohaematology-dgti-workshop-advanced-therapy-medicinal-products-how-bring-cell-based-medicinal-products_en.pdf"},
    {"id":"28431","name":"Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Pravachol and associated names (See Annex I) International Non-Proprietary Name (INN): Pravastatin: Background informatio...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-03-03T00:08:21Z","last_updated_date":"2004-03-03T00:08:21Z","reference_number":"EMEA/CPMP/6214/03/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-pursuant-article-30-council-directive-200183ec-pravachol-and-associated-names-see-annex-i-international-non-proprietary-name-inn-pravastatin-background-informatio_en.pdf"},
    {"id":"28433","name":"Presentation - Procedure for election of PCWP Co-Chair 2013-2016","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedure-election-pcwp-co-chair-2013-2016_en.pdf"},
    {"id":"28435","name":"Superseded final community herbal monograph on Achillea millefolium L., herba - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-09-30T02:00:00Z","last_updated_date":"2011-09-30T02:00:00Z","reference_number":"EMA/HMPC/290284/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-achillea-millefolium-l-herba-first-version_en.pdf"},
    {"id":"28437","name":"Fluoroquinolones and the SOS response - Cà³ilà­n Nunan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/fluoroquinolones-and-sos-response-ca3ila-n-nunan_en.pdf"},
    {"id":"28438","name":"Presentation - Genomics in science and clinical care","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-genomics-science-and-clinical-care_en.pdf"},
    {"id":"28439","name":"Overview of comments received on 'Reflection paper on quality, non-clinical and clinical issues related to the development of recombinant adeno-associated viral vectors'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-07-08T02:00:00Z","last_updated_date":"2010-07-08T02:00:00Z","reference_number":"EMA/CHMP/GTWP/629733/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-quality-non-clinical-and-clinical-issues-related-development-recombinant-adeno-associated-viral-vectors_en.pdf"},
    {"id":"28440","name":"Presentation - ERN case studies: BOND ERN (Luca Sangiorgi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ern-case-studies-bond-ern-luca-sangiorgi_en.pdf"},
    {"id":"28441","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations - November 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-11-13T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"EMA/632557/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations-november-2014_en.pdf"},
    {"id":"28442","name":"Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease): List of nationally authorised medicinal products - PSUSA/00001556/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-10-17T15:38:44Z","reference_number":"EMA/474049/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/glycopyrronium-bromide-all-indications-except-chronic-obstructive-pulmonary-disease-list-nationally-authorised-medicinal-products-psusa00001556201509_en.pdf"},
    {"id":"28443","name":"Guideline on clinical medicinal products intended for the treatment of neuropathic pain","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-01-24T01:00:00Z","last_updated_date":"2007-01-24T01:00:00Z","reference_number":"CPMP/EWP/252/03 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-medicinal-products-intended-treatment-neuropathic-pain_en.pdf"},
    {"id":"28444","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Italian Neonatal Network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-05-17T02:00:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/153645/2011","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-italian-neonatal-network_en.pdf"},
    {"id":"28445","name":"EU/3/10/766: Public summary of opinion on orphan designation of Pyr-His-Trp-Ser-Tyr-D-Lys(doxorubicinylglutarate)-Leu-Arg-Pro-Gly-NH2, acetate salt for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-11T01:31:00Z","last_updated_date":"2017-08-16T12:55:00Z","reference_number":"EMA/COMP/320551/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310766-public-summary-opinion-orphan-designation-pyr-his-trp-ser-tyr-d-lysdoxorubicinylglutarate-leu-arg-pro-gly-nh2-acetate-salt-treatment-ovarian-cancer_en.pdf"},
    {"id":"28447","name":"CVMP post-authorisation summary of positive opinion for Novem (X/0018)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/CVMP/140608/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-novem-x0018_en.pdf"},
    {"id":"28448","name":"Capecitabine film-coated tablets 150, 500 mg product-specific bioequivalence guidance - adopted","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/315237/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/capecitabine-film-coated-tablets-150-500-mg-product-specific-bioequivalence-guidance-adopted_en.pdf"},
    {"id":"28450","name":"Agenda - European Union regulatory workshop in ophthalmology","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2011-07-04T02:00:00Z","last_updated_date":"2011-07-04T02:00:00Z","reference_number":"EMA/375555/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-union-regulatory-workshop-ophthalmology_en.pdf"},
    {"id":"28451","name":"EU/3/10/803: Public summary of opinion on orphan designation chimeric monoclonal antibody against claudin-18 splice variant 2 for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2010-12-15T01:00:00Z","reference_number":"EMA/579374/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310803-public-summary-opinion-orphan-designation-chimeric-monoclonal-antibody-against-claudin-18-splice-variant-2-treatment-gastric-cancer_en.pdf"},
    {"id":"28452","name":"Xofigo Article-20 procedure - Annex I-II-III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T13:00:00Z","last_updated_date":"2018-03-09T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/xofigo-article-20-procedure-annex-i-ii-iii_en.pdf"},
    {"id":"28453","name":"Final list of references supporting the assessment of Adhatoda vasica Nees, folium - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/HMPC/681469/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-adhatoda-vasica-nees-folium-first-version_en.pdf"},
    {"id":"28455","name":"Oncoscience AG withdraws its application for Theraloc (nimotuzumab)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-12-04T00:09:21Z","last_updated_date":"2008-12-04T00:09:21Z","reference_number":"EMEA/645579/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/oncoscience-ag-withdraws-its-application-theraloc-nimotuzumab_en.pdf"},
    {"id":"28459","name":"Oral almitrine to be withdrawn by EU Member States","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T12:00:00Z","last_updated_date":"2013-05-31T12:00:00Z","reference_number":"EMA/313994/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/oral-almitrine-be-withdrawn-eu-member-states_en.pdf"},
    {"id":"28461","name":"Public statement on Ultratard (insulin human (rDNA)) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-08-24T14:39:21Z","last_updated_date":"2007-08-24T14:39:21Z","reference_number":"EMEA/368302/2007","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ultratard-insulin-human-rdna-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"28462","name":"Declaration of interests: Agneta Brandt","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-05T15:00:00Z","last_updated_date":"2017-08-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-agneta-brandt_en.pdf"},
    {"id":"28466","name":"EU/3/16/1714 : Public summary of opinion on orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate for the treatment of mucopolysaccharidosis type I","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-11T19:05:00Z","last_updated_date":"2016-10-11T19:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161714-public-summary-opinion-orphan-designation-6-r-methyl-5-o-5-amino-56-dideoxy-i-l-talofuranosyl-paromamine-sulfate-treatment-mucopolysaccharidosis-type-i_en.pdf"},
    {"id":"28467","name":"Draft note for guidance on the investigation of bioavailability and bioequivalence","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2000-12-14T01:00:00Z","last_updated_date":"2000-12-14T01:00:00Z","reference_number":"CPMP/EWP/QWP/1401/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-note-guidance-investigation-bioavailability-and-bioequivalence_en.pdf"},
    {"id":"28468","name":"Final assessment report on Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/897384/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-paullinia-cupana-kunth-ex-hbk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
    {"id":"28470","name":"Presentation - Update on Working Group 10 (Mark Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-working-group-10-mark-turner_en.pdf"},
    {"id":"28472","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (graft-versus-host disease)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:30:00Z","last_updated_date":"2015-10-30T11:30:00Z","reference_number":"EMA/562243/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-mesenchymal-stem-cells-derived-whartons-jelly-tissue-umbilical-cord-graft-versus-host-disease_en.pdf"},
    {"id":"28473","name":"European Medicines Agency recommends authorisation of first generic\n\nmedicine for human use","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/316728/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-authorisation-first-generic-medicine-human-use_en.pdf"},
    {"id":"28474","name":"Presentation - Implementation of the new pharmacovigilance legislation: update on status (Franck Diafouka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-new-pharmacovigilance-legislation-update-status-franck-diafouka_en.pdf"},
    {"id":"28478","name":"Rafoxanide: European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2016-05-03T13:02:00Z","last_updated_date":"2016-05-03T13:02:00Z","reference_number":"EMA/CVMP/700819/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/rafoxanide-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"28479","name":"Animal health experts call for global cooperation to boost animal health product availability and innovation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-23T00:09:21Z","last_updated_date":"2007-11-23T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/animal-health-experts-call-global-cooperation-boost-animal-health-product-availability-and-innovation_en.pdf"},
    {"id":"28480","name":"Committee for Orphan Medicinal Products (COMP): Monthly report from the September 2011 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-09-20T17:13:00Z","last_updated_date":"2011-09-20T17:13:00Z","reference_number":"EMA/COMP/399956/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-september-2011-meeting_en.pdf"},
    {"id":"28483","name":"Patient Registry Initiative- Strategy and Mandate of the Cross-Committee Task Force","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-15T15:36:00Z","last_updated_date":"2017-05-15T15:36:00Z","reference_number":"EMA/180341/2017","document_url":"https://www.ema.europa.eu/en/documents/other/patient-registry-initiative-strategy-and-mandate-cross-committee-task-force_en.pdf"},
    {"id":"28485","name":"Core SPC for human Rabies immunoglobulin for intramuscular use\n\n(CPMP/BPWG/3728/02)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"CPMP/BPWG/3728/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/core-spc-human-rabies-immunoglobulin-intramuscular-use-cpmpbpwg372802_en.pdf"},
    {"id":"28490","name":"PCWP (2006-2016) - The original PCWP members describe the highlights and challenges of the last 10 years","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-21T01:00:00Z","last_updated_date":"2016-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pcwp-2006-2016-original-pcwp-members-describe-highlights-and-challenges-last-10-years_en.pdf"},
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    {"id":"28492","name":"Priorix - Article 30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-06-19T02:00:00Z","last_updated_date":"2012-06-19T02:00:00Z","reference_number":"EMA/360443/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/priorix-article-30-referral-assessment-report_en.pdf"},
    {"id":"28495","name":"Presentation - Relaunch of EMA corporate website- EMA's PCWP and HCPWP joint meeting (Angela-Christina Schmidt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-relaunch-ema-corporate-website-emas-pcwp-and-hcpwp-joint-meeting-angela-christina-schmidt_en.pdf"},
    {"id":"28496","name":"Scientific recommendation on classification of advanced therapy medicinal products: human amniotic membrane mesenchymal stem cells seeded on acellular amniotic matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T13:00:00Z","last_updated_date":"2016-04-12T13:00:00Z","reference_number":"EMA/241011/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-amniotic-membrane-mesenchymal-stem-cells-seeded-acellular-amniotic-matrix_en.pdf"},
    {"id":"28497","name":"Guidelines and concept papers adopted during the CHMP meeting 16-19 January 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-23T17:35:00Z","last_updated_date":"2012-01-23T17:35:00Z","reference_number":"EMA/CHMP/8908/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-16-19-january-2012_en.pdf"},
    {"id":"28498","name":"Work plan for the Vaccine Working Party 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-12-21T17:20:00Z","last_updated_date":"2017-12-21T17:20:00Z","reference_number":"EMA/CHMP/VWP/515395/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-vaccine-working-party-2018_en.pdf"},
    {"id":"28500","name":"EU regulatory network reflection paper on the availability of authorised medicinal products for human and veterinary use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-08-29T14:00:00Z","last_updated_date":"2018-08-29T14:00:00Z","reference_number":"EMA/565780/2018","document_url":"https://www.ema.europa.eu/en/documents/other/eu-regulatory-network-reflection-paper-availability-authorised-medicinal-products-human-and-veterinary-use_en.pdf"},
    {"id":"28501","name":"Ad hoc working party on Herbal Medicinal Products:  Final comments for revision of the notice to applicants volume 2B part II: concerning chemical, pharmaceutical and biological documentation for vegetable medicinal prod...","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-01-28T01:00:00Z","last_updated_date":"1999-01-28T01:00:00Z","reference_number":"EMEA/HMPWP/8/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-party-herbal-medicinal-products-final-comments-revision-notice-applicants-volume-2b-part-ii-concerning-chemical-pharmaceutical-and-biological-documentation-vegetable-medicinal-prod_en.pdf"},
    {"id":"28502","name":"Presentation - Good pharmacovigilance practices module X - additional monitoring of medicines (Mick Foy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-module-x-additional-monitoring-medicines-mick-foy_en.pdf"},
    {"id":"28503","name":"EMEA 2010 Priorities for Drug Safety Research: Long-term adverse skeletal effects of bisphosphonates","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-08-04T02:00:00Z","last_updated_date":"2009-08-04T02:00:00Z","reference_number":"EMEA/493711/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/emea-2010-priorities-drug-safety-research-long-term-adverse-skeletal-effects-bisphosphonates_en.pdf"},
    {"id":"28505","name":"Presentation - BMWP-Interested Party Meeting 2017 (C. Vleminckx, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bmwp-interested-party-meeting-2017-c-vleminckx-ema_en.pdf"},
    {"id":"28506","name":"VICH GL3: Stability testing of new veterinary drug substances and medicinal products - Step 7 (after revision at step 9)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-02-19T01:00:00Z","last_updated_date":"2007-02-19T01:00:00Z","reference_number":"EMEA/CVMP/VICH/899/99-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl3-stability-testing-new-veterinary-drug-substances-and-medicinal-products-step-7-after-revision-step-9_en.pdf"},
    {"id":"28508","name":"Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-01-24T18:00:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/118465/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xv-safety-communication-rev-1_en.pdf"},
    {"id":"28510","name":"CHMP summary of positive opinion for Olysio","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2018-05-23T14:00:00Z","reference_number":"EMA/CHMP/137969/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-olysio_en.pdf"},
    {"id":"28511","name":"Recommendations from the Joint EMA/HMA Steering Group on veterinary vaccine availability to CVMP based on the outcome of the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:30:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"EMA/548726/2017","document_url":"https://www.ema.europa.eu/en/documents/other/recommendations-joint-emahma-steering-group-veterinary-vaccine-availability-cvmp-based-outcome-focus-group-meeting-invited-stakeholders-field-efficacy-trials-context-eu_en.pdf"},
    {"id":"28512","name":"EU/3/07/504: Public summary of  positive opinion for orphan designation: Irinotecan hydrochloride (drug-eluting beads) for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-01T02:00:00Z","last_updated_date":"2017-04-25T02:00:00Z","reference_number":"EMA/COMP/539060/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307504-public-summary-positive-opinion-orphan-designation-irinotecan-hydrochloride-drug-eluting-beads-treatment-glioma_en.pdf"},
    {"id":"28513","name":"Rabbit anti-human thymocyte (concentrate for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010252/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-06T12:00:00Z","last_updated_date":"2016-10-17T19:31:35Z","reference_number":"EMA/532392/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabbit-anti-human-thymocyte-concentrate-solution-infusion-list-nationally-authorised-medicinal-products-psusa00010252201412_en.pdf-0"},
    {"id":"28517","name":"CHMP statistics: July 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-july-2017_en.pdf"},
    {"id":"28519","name":"Dihydroergotamine: List of nationally authorised medicinal products - PSUSA/00001075/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T13:00:00Z","last_updated_date":"2016-10-17T19:52:26Z","reference_number":"EMA/788899/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/dihydroergotamine-list-nationally-authorised-medicinal-products-psusa00001075201504_en.pdf"},
    {"id":"28521","name":"Agenda and registration form - 13th EudraVigilance information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-09-13T02:00:00Z","last_updated_date":"2012-09-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-13th-eudravigilance-information-day_en.pdf"},
    {"id":"28522","name":"Polymyxin Article-31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-05T01:00:00Z","last_updated_date":"2015-01-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/polymyxin-article-31-referral-assessment-report_en.pdf"},
    {"id":"28523","name":"European Medicines Agency’s interaction with industry stakeholders - Annual report 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-08-03T17:10:00Z","last_updated_date":"2018-08-03T17:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencys-interaction-industry-stakeholders-annual-report-2017_en.pdf"},
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    {"id":"28529","name":"CVMP post-authorisation summary of positive opinion for Semintra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-03-16T01:00:00Z","last_updated_date":"2018-03-16T01:00:00Z","reference_number":"EMA/CVMP/25787/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-semintra_en.pdf"},
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    {"id":"28531","name":"Presentation - From Social to Medical: How is digital information being used? (Ciro Cattuto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-social-medical-how-digital-information-being-used-ciro-cattuto_en.pdf"},
    {"id":"28532","name":"Agenda - Training session on the new pharmaceutical legislation, 29 November 2012","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T17:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"EMA/483816/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-new-pharmaceutical-legislation-29-november-2012_en.pdf"},
    {"id":"28534","name":"CHMP summary of positive opinion for Lacosamide Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/CHMP/370634/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lacosamide-accord_en.pdf"},
    {"id":"28536","name":"Work instructions for user registration and management - Maintenance of the European Pharmacovigilance Issues Tracking Tool (EPITT) accounts and provision of trainings to users","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-04-14T02:00:00Z","last_updated_date":"2016-10-20T19:05:00Z","reference_number":"WIN/H/3369","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-user-registration-and-management-maintenance-european-pharmacovigilance-issues-tracking-tool-epitt-accounts-and-provision-trainings-users_en.pdf"},
    {"id":"28537","name":"When patients and consumers join forces","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-21T01:00:00Z","last_updated_date":"2016-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/when-patients-and-consumers-join-forces_en.pdf"},
    {"id":"28538","name":"Committee for veterinary medicinal products: Meeting of 1 to 3 October 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-10-04T14:09:21Z","last_updated_date":"2002-10-04T14:09:21Z","reference_number":"EMEA/CVMP/969/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-1-3-october-2002_en.pdf"},
    {"id":"28540","name":"Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting 20 September 2017","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T02:00:00Z","last_updated_date":"2017-10-26T02:00:00Z","reference_number":"EMA/626905/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-20-september-2017_en.pdf"},
    {"id":"28541","name":"Online strategy and interface design EMA/2012/37/ED - Letter of invitation to tender","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"EMA/668077/2012","document_url":"https://www.ema.europa.eu/en/documents/other/online-strategy-and-interface-design-ema201237ed-letter-invitation-tender_en.pdf"},
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    {"id":"28546","name":"Presentation - Proposal for EU network of patients acting as contact point for PhV (F. Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T17:06:00Z","last_updated_date":"2017-12-11T17:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-eu-network-patients-acting-contact-point-phv-f-houyez_en.pdf"},
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    {"id":"28551","name":"EU/3/02/110: Public summary of positive opinion for orphan designation of thymalfasin for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-08T01:00:00Z","last_updated_date":"2003-01-08T01:00:00Z","reference_number":"EMEA/COMP/1477/02 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302110-public-summary-positive-opinion-orphan-designation-thymalfasin-treatment-hepatocellular-carcinoma_en.pdf"},
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    {"id":"28555","name":"Sponsoring of Patients’ Organisations by pharmaceutical industry – proposed actions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/MB/531926/2010","document_url":"https://www.ema.europa.eu/en/documents/other/sponsoring-patients-organisations-pharmaceutical-industry-proposed-actions_en.pdf"},
    {"id":"28556","name":"EudraVigilance registration: questions and answers","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2017-03-27T16:37:00Z","reference_number":"EMA/353007/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-registration-questions-and-answers_en.pdf"},
    {"id":"28557","name":"Work plan for Good Clinical Practice inspectors Working Group (GCP IWG) for 2008","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-08-12T02:00:00Z","last_updated_date":"2008-08-12T02:00:00Z","reference_number":"EMEA/INS/GCP/546619/2007","document_url":"https://www.ema.europa.eu/en/documents/other/work-plan-good-clinical-practice-inspectors-working-group-gcp-iwg-2008_en.pdf"},
    {"id":"28560","name":"CVMP post-authorisation summary of positive opinion for Metacam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-05-06T02:00:00Z","last_updated_date":"2011-05-06T02:00:00Z","reference_number":"EMA/CVMP/62249/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam_en.pdf-5"},
    {"id":"28561","name":"Draft community herbal monograph on Ispaghula husk (Plantago ovate, tegumentum)","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-10-24T02:00:00Z","last_updated_date":"2005-10-24T02:00:00Z","reference_number":"EMEA/HMPC/340857/2005","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-ispaghula-husk-plantago-ovate-tegumentum_en.pdf"},
    {"id":"28563","name":"Guideline on xenogeneic cell-based medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-12-01T00:09:21Z","last_updated_date":"2009-12-01T00:09:21Z","reference_number":"EMEA/CHMP/CPWP/83508/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-xenogeneic-cell-based-medicinal-products_en.pdf"},
    {"id":"28566","name":"Final community herbal monograph on Filipendula ulmaria (L.) Maxim., flos - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-09-29T02:00:00Z","last_updated_date":"2011-09-29T02:00:00Z","reference_number":"EMA/HMPC/434894/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-filipendula-ulmaria-l-maxim-flos-first-version_en.pdf"},
    {"id":"28568","name":"Public statement on Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T01:00:00Z","last_updated_date":"2016-03-07T01:00:00Z","reference_number":"EMEA/H/C/002269","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-prepandemic-influenza-vaccine-h5n1-surface-antigen-inactivated-adjuvanted-novartis-vaccines-and-diagnostic-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"28569","name":"Chloroform: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-07-01T02:00:00Z","last_updated_date":"1996-07-01T02:00:00Z","reference_number":"EMEA/MRL/118/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/chloroform-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28571","name":"Overview of comments received on European Union herbal monograph and European Union herbal list entry on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other spe(..) - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2015-04-09T13:00:00Z","last_updated_date":"2015-04-09T13:00:00Z","reference_number":"EMA/HMPC/166767/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-and-european-union-herbal-list-entry-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-andor-other_en.pdf"},
    {"id":"28572","name":"European Medicines Agency to publish information on ongoing medicine evaluations","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T16:11:11Z","last_updated_date":"2012-02-17T16:11:11Z","reference_number":"EMA/123332/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-publish-information-ongoing-medicine-evaluations_en.pdf"},
    {"id":"28574","name":"Presentation - PedNet registry (Rolf Ljung)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pednet-registry-rolf-ljung_en.pdf"},
    {"id":"28575","name":"Final opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 6mg/ml and Annexes A, B and I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-01-22T00:08:21Z","last_updated_date":"1998-01-22T00:08:21Z","reference_number":"CPMP/257/98-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-6mgml-and-annexes-b-and-i_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-6mgml-and-annexes-b-and-i_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-6mgml-and-annexes-b-and-i_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-6mgml-and-annexes-b-and-i_fr.pdf"}},
    {"id":"28577","name":"Online strategy and interface design EMA/2012/37/ED – Technical specification annex I - Costing sheet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T02:00:00Z","last_updated_date":"2013-06-07T02:00:00Z","reference_number":"EMA/150442/2013","document_url":"https://www.ema.europa.eu/en/documents/other/online-strategy-and-interface-design-ema201237ed-technical-specification-annex-i-costing-sheet_en.xls"},
    {"id":"28579","name":"Presentation: Improving new drug development for children and adolescents: The ACCELERATE initiative","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-improving-new-drug-development-children-and-adolescents-accelerate-initiative_en.pdf"},
    {"id":"28580","name":"CHMP post-authorisation summary of positive opinion for Mirapexin on 25 June 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-07-13T02:00:00Z","last_updated_date":"2009-07-13T02:00:00Z","reference_number":"EMEA/CHMP/395371/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mirapexin-25-june-2009_en.pdf"},
    {"id":"28581","name":"Points to consider on the estimation and reporting of the prevalence of a condition for orphan designation","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-03-22T01:00:00Z","last_updated_date":"2019-06-21T10:00:00Z","reference_number":"EMA/COMP/436/01 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/points-consider-estimation-and-reporting-prevalence-condition-orphan-designation_en.pdf"},
    {"id":"28583","name":"Seventh ESVAC report: sales of veterinary antimicrobial agents in 30 European\n\ncountries in 2015","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-16T14:00:00Z","last_updated_date":"2018-01-18T17:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/seventh-esvac-report-sales-veterinary-antimicrobial-agents-30-european-countries-2015_en.pdf"},
    {"id":"28584","name":"Overview of comments on draft Community herbal monograph on Lavandula angustifolia P. Mill., flos","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2012-06-13T17:00:00Z","last_updated_date":"2012-06-13T17:00:00Z","reference_number":"EMA/HMPC/734383/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-draft-community-herbal-monograph-lavandula-angustifolia-p-mill-flos_en.pdf"},
    {"id":"28585","name":"New gene therapy for the treatment of children with ultra-rare immune disorder recommended for approval","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/230486/2016 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-gene-therapy-treatment-children-ultra-rare-immune-disorder-recommended-approval_en.pdf"},
    {"id":"28587","name":"Committee for Medicinal Products for Human Use (CHMP) - November 2009 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-11-30T00:09:21Z","last_updated_date":"2009-11-30T00:09:21Z","reference_number":"EMEA/CHMP/745639/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-november-2009-plenary-meeting-monthly-report_en.pdf"},
    {"id":"28590","name":"Agenda – Annual workshop on the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-03-12T10:05:00Z","last_updated_date":"2012-03-12T10:05:00Z","reference_number":"EMA/39173/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"28591","name":"Overview of comments on 'Asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/162825/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-asenapine-sublingual-tablets-5-and-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"28593","name":"Presentation - European Medicines Agency progress and status - what is needed to document scientific understanding in a process-analytical-technology application (Claus Mortensen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-07-21T02:00:00Z","last_updated_date":"2006-07-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-progress-and-status-what-needed-document-scientific-understanding-process-analytical-technology-application-claus-mortensen_en.pdf"},
    {"id":"28594","name":"CHMP summary of positive opinion for Abasria","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/CHMP/340931/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-abasria_en.pdf"},
    {"id":"28597","name":"EU/3/15/1470: Public summary of positive opinion for orphan designation of  5,10,15,20-tetrakis(2,6-difluoro-3-N-methylsulfamoylphenyl)bacteriochlorin for the treatment of biliary tract cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/126073/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151470-public-summary-positive-opinion-orphan-designation-5101520-tetrakis26-difluoro-3-n-methylsulfamoylphenylbacteriochlorin-treatment-biliary-tract-cancer_en.pdf"},
    {"id":"28603","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 20-23 June 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-06-30T18:00:00Z","last_updated_date":"2016-06-30T18:00:00Z","reference_number":"EMA/76608/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-20-23-june-2016_en.pdf"},
    {"id":"28605","name":"Kanamycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/514/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/kanamycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28607","name":"Questions and answers on sodium used as an excipient in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/338679/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-sodium-used-excipient-medicinal-products-human-use_en.pdf"},
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    {"id":"28611","name":"Summary of transfers of appropriations in budget 2017 - Management Board meeting: 14-15 June 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-06-16T15:30:00Z","last_updated_date":"2017-06-16T15:30:00Z","reference_number":"EMA/MB/109400/2017","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2017-management-board-meeting-14-15-june-2017_en.pdf"},
    {"id":"28612","name":"CHMP post-authorisation summary of positive opinion for Glivec","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T14:00:00Z","last_updated_date":"2013-05-31T14:00:00Z","reference_number":"EMA/CHMP/332285/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-glivec_en.pdf"},
    {"id":"28613","name":"Presentation - How to get better data on medicines post-licensing","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-get-better-data-medicines-post-licensing_en.pdf"},
    {"id":"28618","name":"EU/3/14/1414: Public summary of opinion on orphan designation: Sodium thiosulfate for the treatment for calciphylaxis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/COMP/786341/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141414-public-summary-opinion-orphan-designation-sodium-thiosulfate-treatment-calciphylaxis_en.pdf"},
    {"id":"28620","name":"Withdrawal letter: Pemetrexed ditromethamine Hospira","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-pemetrexed-ditromethamine-hospira_en.pdf"},
    {"id":"28621","name":"Minutes of the 68th meeting of the Management Board: 7 October 2010","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/MB/628133/2010","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-68th-meeting-management-board-7-october-2010_sv.pdf"}},
    {"id":"28623","name":"EU/3/01/063: Public summary of positive opinion for orphan designation of deoxyribose phosphorothioate (5’-tct-ccc-agc-gtg-cgc-cat-3’) for the treatment of chronic lymphocytic leukemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-01-06T00:00:00Z","last_updated_date":"2013-04-09T02:00:00Z","reference_number":"EMA/COMP/10718/2003 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301063-public-summary-positive-opinion-orphan-designation-deoxyribose-phosphorothioate-5-tct-ccc-agc-gtg-cgc-cat-3-treatment-chronic-lymphocytic-leukemia_en.pdf"},
    {"id":"28625","name":"Protelos and Osseor Article-20 procedure: Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T14:00:00Z","last_updated_date":"2013-05-17T14:00:00Z","reference_number":"EMA/291972/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/protelos-and-osseor-article-20-procedure-review-started_en.pdf"},
    {"id":"28626","name":"CHMP post-authorisation summary of positive opinion for Zydelig","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/108191/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zydelig_en.pdf"},
    {"id":"28627","name":"European Medicines Agency annual report for 2006 shows record numbers of applications; assessment times in core processes significantly reduced","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-03-15T00:09:21Z","last_updated_date":"2007-03-15T00:09:21Z","reference_number":"EMEA/105586/2007-corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-annual-report-2006-shows-record-numbers-applications-assessment-times-core-processes-significantly-reduced_en.pdf"},
    {"id":"28629","name":"Committee for Advanced Therapies (CAT) - Work Plan 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2018-02-13T14:14:00Z","last_updated_date":"2018-02-13T14:14:00Z","reference_number":"EMA/CAT/614550/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/committee-advanced-therapies-cat-work-plan-2018_en.pdf"},
    {"id":"28630","name":"Guidance on format of the risk-management plan in the European Union part VI: Summary of activities in the risk-management plan by product","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2013-08-21T17:00:00Z","reference_number":"EMA/465929/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-vi-summary-activities-risk-management-plan-product_en.doc"},
    {"id":"28632","name":"Download EPS - Species pictograms - Horse","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-horse_en.zip"},
    {"id":"28633","name":"Public Statement on Trovan / Trovan IV / Turvel / Turvel IV (Trovafloxacin/Alatrofloxacin) recommendation to suspend the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-06-15T02:00:00Z","last_updated_date":"1999-06-15T02:00:00Z","reference_number":"EMEA/18046/99","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-trovan-trovan-iv-turvel-turvel-iv-trovafloxacinalatrofloxacin-recommendation-suspend-marketing-authorisation-european-union_en.pdf"},
    {"id":"28634","name":"Monitoring of Sales of Veterinary Antimicrobial Agents in Europe: Considerations from Industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/monitoring-sales-veterinary-antimicrobial-agents-europe-considerations-industry_en.pdf"},
    {"id":"28637","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 24 November 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T11:30:00Z","last_updated_date":"2014-12-12T11:30:00Z","reference_number":"EMA/HMPC/744424/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-24-november-2014_en.pdf"},
    {"id":"28638","name":"EU/3/16/1776: Public summary of positive opinion for orphan designation of ascorbic acid for the treatment of facioscapulohumeral muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T14:28:00Z","last_updated_date":"2016-12-14T14:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161776-public-summary-positive-opinion-orphan-designation-ascorbic-acid-treatment-facioscapulohumeral-muscular-dystrophy_en.pdf"},
    {"id":"28640","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Pediatric Rheumatology International Trials Organisation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-pediatric-rheumatology-international-trials-organisation_en.pdf"},
    {"id":"28642","name":"Presentation - The changing diagnostic criteria for Alzheimer's disease, including early and asymptomatic disease stages and their impact on clinical trial design (Eric Siemers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-changing-diagnostic-criteria-alzheimers-disease-including-early-and-asymptomatic-disease-stages-and-their-impact-clinical-trial-design-eric-siemers_en.pdf"},
    {"id":"28643","name":"Tioconazole, tioconazole / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00010382/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T17:00:00Z","last_updated_date":"2017-12-11T17:00:00Z","reference_number":"EMA/812660/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tioconazole-tioconazole-hydrocortisone-list-nationally-authorised-medicinal-products-psusa00010382201704_en.pdf"},
    {"id":"28644","name":"Presentation - EudraVigilance components and functionality introduction: training module PhV-M2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T13:18:00Z","last_updated_date":"2016-10-10T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-components-and-functionality-introduction-training-module-phv-m2_en.pdf"},
    {"id":"28645","name":"Committee for medicinal products for veterinary use: Meeting of 12 to 14 April 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-04-15T14:39:21Z","last_updated_date":"2009-04-15T14:39:21Z","reference_number":"EMEA/CVMP/119411/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-12-14-april-2005_en.pdf"},
    {"id":"28647","name":"Notification of parallel distribution of a centrally authorised medicinal product","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-04-01T02:00:00Z","last_updated_date":"2013-07-09T11:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/notification-parallel-distribution-centrally-authorised-medicinal-product_en.pdf"},
    {"id":"28649","name":"Questions and answers relating to restricted tender procedure – EMA/2013/21/IS Provision of Security Consumables","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T12:35:00Z","last_updated_date":"2013-11-05T09:16:00Z","reference_number":"EMA/614964/2013","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-restricted-tender-procedure-ema201321is-provision-security-consumables_en.pdf"},
    {"id":"28650","name":"5 Fluorouracil, salicylic acid: List of nationally authorised medicinal products - PSUSA/00000008/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-11T02:00:00Z","last_updated_date":"2016-10-17T16:40:32Z","reference_number":"EMA/4301/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/5-fluorouracil-salicylic-acid-list-nationally-authorised-medicinal-products-psusa00000008201505_en.pdf"},
    {"id":"28651","name":"Reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-02-01T01:00:00Z","last_updated_date":"2010-02-01T01:00:00Z","reference_number":"EMA/HMPC/85114/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-ethanol-content-herbal-medicinal-products-and-traditional-herbal-medicinal-products-used-children_en.pdf"},
    {"id":"28654","name":"Zinbryta Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T01:00:00Z","last_updated_date":"2018-03-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-notification_en.pdf"},
    {"id":"28656","name":"Fentanyl (transdermal patches, solution for injection): List of nationally authorised medicinal products - PSUSA/00001370/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-31T02:00:00Z","last_updated_date":"2016-10-18T16:14:17Z","reference_number":"EMA/230161/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/fentanyl-transdermal-patches-solution-injection-list-nationally-authorised-medicinal-products-psusa00001370201504_en.pdf"},
    {"id":"28658","name":"Divergent position on a revised CVMP opinion on an Article-35 referral for Hipralona Enro-S and its generics indicated for use in rabbits","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-02-04T01:00:00Z","last_updated_date":"2013-02-04T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-revised-cvmp-opinion-article-35-referral-hipralona-enro-s-and-its-generics-indicated-use-rabbits_en.pdf"},
    {"id":"28662","name":"Fenoterol (obstetric indications): List of nationally authorised medicinal products - PSUSA/00010001/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-05-20T02:00:00Z","last_updated_date":"2016-10-18T16:14:15Z","reference_number":"EMA/346558/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/fenoterol-obstetric-indications-list-nationally-authorised-medicinal-products-psusa00010001201509_en.pdf"},
    {"id":"28663","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Melilotus officinalis (L.) Lam., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/HMPC/305054/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-melilotus-officinalis-l-lam-herba_en.pdf"},
    {"id":"28664","name":"Superseded final list of references supporting the assessment of Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"EMA/HMPC/130045/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-references-supporting-assessment-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"28665","name":"Committee for veterinary medicinal products: Meeting of 13 to 15 January 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-01-16T12:39:21Z","last_updated_date":"2004-01-16T12:39:21Z","reference_number":"EMEA/CVMP/081/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-13-15-january-2004_en.pdf"},
    {"id":"28670","name":"EU/3/07/431: Public summary of positive opinion for orphan designation of autologous dendritic cells pulsed with autologous tumour cell lysate for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/96767/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307431-public-summary-positive-opinion-orphan-designation-autologous-dendritic-cells-pulsed-autologous-tumour-cell-lysate-treatment-glioma_en.pdf"},
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    {"id":"28692","name":"European Medicines Agency recommends use of fibrates as second-line treatment","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/649010/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-use-fibrates-second-line-treatment_en.pdf"},
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    {"id":"28708","name":"EU/3/15/1593: Public summary of opinion on orphan designation: Imetelstat sodium for the treatment of myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2016-02-03T01:00:00Z","reference_number":"EMA/COMP/777525/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151593-public-summary-opinion-orphan-designation-imetelstat-sodium-treatment-myelofibrosis_en.pdf"},
    {"id":"28709","name":"EMA-EUnetHTA work plan 2017-2021","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T15:30:00Z","last_updated_date":"2020-05-05T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-eunethta-work-plan-2017-2021_en.pdf"},
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    {"id":"28718","name":"European Medicines Agency agrees to precautionary recall of Advagraf 0.5 mg capsule batches","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-10-20T17:59:08Z","last_updated_date":"2011-10-20T17:59:08Z","reference_number":"EMA/CHMP/840800/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-agrees-precautionary-recall-advagraf-05-mg-capsule-batches_en.pdf"},
    {"id":"28721","name":"The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future: Part II: The European Medicines Agency Road Map Implementation Plan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-03-07T01:00:00Z","last_updated_date":"2005-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-road-map-2010-preparing-ground-future-part-ii-european-medicines-agency-road-map-implementation-plan_en.pdf"},
    {"id":"28722","name":"Draft list of references for assessment of Orthosiphonis staminei folium Orthosiphon stamineus Benth., folium (Java tea)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-07-16T02:09:21Z","last_updated_date":"2009-07-16T02:09:21Z","reference_number":"EMEA/HMPC/281529/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-orthosiphonis-staminei-folium-orthosiphon-stamineus-benth-folium-java-tea_en.pdf"},
    {"id":"28723","name":"Benefit-risk methodology project: Comments received from Dr William Holden on the work package 2 report","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-09T17:04:06Z","last_updated_date":"2011-06-09T17:04:06Z","reference_number":"EMA/314182/2011","document_url":"https://www.ema.europa.eu/en/documents/other/benefit-risk-methodology-project-comments-received-dr-william-holden-work-package-2-report_en.pdf"},
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    {"id":"28784","name":"Report on withdrawn centralised applications 1995-1998","type":"report","status":"unknown","consultation_date":"","first_published_date":"1999-05-20T02:00:00Z","last_updated_date":"1999-05-20T02:00:00Z","reference_number":"EMEA/H/14994/99","document_url":"https://www.ema.europa.eu/en/documents/report/report-withdrawn-centralised-applications-1995-1998_en.pdf"},
    {"id":"28786","name":"Minutes of the European Medicines Agency and European Network for Health Technology Assessment meeting -  November 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-and-european-network-health-technology-assessment-meeting-november-2012_en.pdf"},
    {"id":"28788","name":"Biosimilar mAbs - Outlook - Christian K Schneider","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/biosimilar-mabs-outlook-christian-k-schneider_en.pdf"},
    {"id":"28792","name":"Presentation: Severe Paediatric Asthma Collaborative in Europe (SPACE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-severe-paediatric-asthma-collaborative-europe-space_en.pdf"},
    {"id":"28794","name":"European Directorate for the Quality of Medicines & HealthCare: Structure, Aims and Role in Providing Safety and Quality of Medicines in Europe - Susanne Keitel","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-directorate-quality-medicines-healthcare-structure-aims-and-role-providing-safety-and-quality-medicines-europe-susanne-keitel_en.pdf"},
    {"id":"28796","name":"Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fenofibrato-pensa-and-fenofibrato-ranbaxy-article-31-referral-annex-iii_fi.pdf"}},
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    {"id":"28829","name":"EU/3/13/1170: Public summary of opinion on orphan designation: Octreotide acetate (oral use) for treatment of acromegaly","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-09-12T02:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/COMP/443659/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131170-public-summary-opinion-orphan-designation-octreotide-acetate-oral-use-treatment-acromegaly_en.pdf"},
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    {"id":"28836","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of  22-25 February 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-03-04T15:00:00Z","last_updated_date":"2016-03-04T15:00:00Z","reference_number":"EMA/76583/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-22-25-february-2016_en.pdf"},
    {"id":"28838","name":"Presentation - Opportunities for public health and pharmacogenomics from the new pharmacovigilance legislation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-public-health-and-pharmacogenomics-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"28839","name":"Final European Union herbal monograph on Peumus boldus Molina, folium","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2017-01-12T10:48:00Z","last_updated_date":"2017-01-12T10:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-peumus-boldus-molina-folium_en.pdf"},
    {"id":"28840","name":"Safety Pharmacology - Klaus Olejniczak","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/safety-pharmacology-klaus-olejniczak_en.pdf"},
    {"id":"28843","name":"Preclinical requirements, Dr David Jones","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/preclinical-requirements-dr-david-jones_en.pdf"},
    {"id":"28844","name":"EU/3/11/930: Public summary of opinion on orphan designation: Resminostat for the treatment of Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/COMP/862754/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311930-public-summary-opinion-orphan-designation-resminostat-treatment-hodgkins-lymphoma_en.pdf"},
    {"id":"28845","name":"Position paper on control of impurities of pharmacopoeial substances: Compliance with the European pharmacopoeia general monograph 'Substances for pharmaceutical use' and general chapter 'Control of impurities in substan...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-03-01T01:00:00Z","last_updated_date":"2004-03-01T01:00:00Z","reference_number":"EMEA/CVMP/059/04 -FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-control-impurities-pharmacopoeial-substances-compliance-european-pharmacopoeia-general-monograph-substances-pharmaceutical-use-and-general-chapter-control-impurities-substan_en.pdf"},
    {"id":"28846","name":"Summary of questions discussed and answers provided on VeDDRA coding at the workshop held on 27 November 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-11T18:20:00Z","last_updated_date":"2014-02-11T18:20:00Z","reference_number":"EMA/804163/2013","document_url":"https://www.ema.europa.eu/en/documents/other/summary-questions-discussed-and-answers-provided-veddra-coding-workshop-held-27-november-2013_en.pdf"},
    {"id":"28847","name":"Presentation - Confirmation of extrapolation based on PK/PD data and modeling (Jacob Brogren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-confirmation-extrapolation-based-pkpd-data-and-modeling-jacob-brogren_en.pdf"},
    {"id":"28851","name":"Re-allocation of eXtended Medicinal Product Dictionary (XEVMPD) Organisation entities ownership to the marketing authorisation holders (MAHs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-13T14:02:00Z","last_updated_date":"2014-02-13T14:02:00Z","reference_number":"EMA/74525/2014","document_url":"https://www.ema.europa.eu/en/documents/other/re-allocation-extended-medicinal-product-dictionary-xevmpd-organisation-entities-ownership-marketing-authorisation-holders-mahs_en.pdf"},
    {"id":"28852","name":"Presentation - Update on WEB-RADR: main aspects raised by HCPs (Adamos Hadjipanayis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-web-radr-main-aspects-raised-hcps-adamos-hadjipanayis_en.pdf"},
    {"id":"28855","name":"EU/3/18/2032: Public summary of opinion on orphan designation: Carmustine for treatment in haematopoietic stem cell transplantation","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T12:47:00Z","last_updated_date":"2018-08-21T12:47:00Z","reference_number":"EMA/355631/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182032-public-summary-opinion-orphan-designation-carmustine-treatment-haematopoietic-stem-cell-transplantation_en.pdf"},
    {"id":"28858","name":"Questions and answers relating to open tender procedure – EMA/2014/01/PH Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-04T15:40:00Z","last_updated_date":"2014-05-08T11:10:00Z","reference_number":"EMA/158242/2014 version 13","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-open-tender-procedure-ema201401ph-monitoring-scientific-and-medical-literature-and-entry-relevant-information-eudravigilance_en.pdf"},
    {"id":"28863","name":"Presentation - Conclusions of the training session for patients and consumers interested in European Medicines Agency activities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-conclusions-training-session-patients-and-consumers-interested-european-medicines-agency-activities_en.pdf"},
    {"id":"28865","name":"Superseded overview of comments received on community herbal monograph on Hypericum perforatum L., herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2009-12-21T00:09:00Z","last_updated_date":"2023-02-22T00:09:00Z","reference_number":"EMA/HMPC/258853/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-hypericum-perforatum-l-herba_en.pdf"},
    {"id":"28867","name":"Agenda - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-07-28T18:30:00Z","last_updated_date":"2017-11-22T16:37:00Z","reference_number":"EMA/CHMP/BWP/149179/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-biologics-working-party-quality-working-party-workshop-stakeholders-relation-prior-knowledge-and-its-use-regulatory-applications_en.pdf"},
    {"id":"28871","name":"Presentation - FVE","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-11T02:00:00Z","last_updated_date":"2011-10-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fve_en.pdf"},
    {"id":"28872","name":"Opinion following an Article 33(4) referral for Bovilis BVD/Bovilis BVD-MD: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T01:59:00Z","last_updated_date":"2008-06-02T01:59:00Z","reference_number":"EMEA/532090/2007– Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-bovilis-bvdbovilis-bvd-md-background-information_sv.pdf"}},
    {"id":"28873","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose derived mesenchymal stem cells, freshly isolated","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/417057/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-adipose-derived-mesenchymal-stem-cells-freshly-isolated_en.pdf"},
    {"id":"28875","name":"Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T12:00:00Z","last_updated_date":"2012-06-25T12:00:00Z","reference_number":"EMA/816292/2011 superseded","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report-superseded_en.pdf"},
    {"id":"28877","name":"Buflomedil - Article 107 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-13T02:00:00Z","last_updated_date":"2012-06-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/buflomedil-article-107-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/buflomedil-article-107-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/buflomedil-article-107-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/buflomedil-article-107-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/buflomedil-article-107-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/buflomedil-article-107-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/buflomedil-article-107-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/buflomedil-article-107-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/buflomedil-article-107-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/buflomedil-article-107-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/buflomedil-article-107-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/buflomedil-article-107-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/buflomedil-article-107-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/buflomedil-article-107-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/buflomedil-article-107-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/buflomedil-article-107-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/buflomedil-article-107-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/buflomedil-article-107-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/buflomedil-article-107-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/buflomedil-article-107-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/buflomedil-article-107-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/buflomedil-article-107-referral-annex-iii_sv.pdf"}},
    {"id":"28879","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-04-30T17:28:00Z","last_updated_date":"2018-04-30T17:28:00Z","reference_number":"EMA/CAT/262029/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2018_en.pdf"},
    {"id":"28880","name":"Dapsone: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-15T02:00:00Z","last_updated_date":"1996-05-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dapsone-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28883","name":"Scientific recommendation on classification of advanced therapy medicinal products: Ex vivo expanded adult human bone-marrow derived pooled allogeneic mesenchymal stromal cells","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T19:00:00Z","last_updated_date":"2015-08-26T19:00:00Z","reference_number":"EMA/567064/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-ex-vivo-expanded-adult-human-bone-marrow-derived-pooled-allogeneic-mesenchymal-stromal-cells_en.pdf"},
    {"id":"28885","name":"Formoterol: List of nationally authorised medicinal products - PSUSA/00001469/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T11:10:00Z","last_updated_date":"2018-01-18T11:10:00Z","reference_number":"EMA/34978/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/formoterol-list-nationally-authorised-medicinal-products-psusa00001469201705_en.pdf"},
    {"id":"28887","name":"Online strategy and interface design EMA/2012/37/ED - Technical specification annex II - Exclusion criteria","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"EMA/150442/2013","document_url":"https://www.ema.europa.eu/en/documents/other/online-strategy-and-interface-design-ema201237ed-technical-specification-annex-ii-exclusion-criteria_en.doc"},
    {"id":"28889","name":"CHMP post-authorisation summary of positive opinion for Jalra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-12-16T01:00:00Z","last_updated_date":"2011-12-16T01:00:00Z","reference_number":"EMA/CHMP/975250/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jalra_en.pdf-0"},
    {"id":"28892","name":"Impurities in drug substances and medicinal products - Hilda Kà¶szegi-Szalai","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/impurities-drug-substances-and-medicinal-products-hilda-kapszegi-szalai_en.pdf"},
    {"id":"28893","name":"CHMP post-authorisation summary of positive opinion for Ipreziv","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2014-12-19T01:00:00Z","reference_number":"EMA/CHMP/569645/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ipreziv_en.pdf"},
    {"id":"28895","name":"Guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CVMP/EWP/459883/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-veterinary-medicinal-products-controlling-varroa-destructor-parasitosis-bees_en.pdf"},
    {"id":"28896","name":"Organisational matters: CHMP meeting 23-26 May 2016","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2016-06-13T12:25:00Z","last_updated_date":"2016-06-13T12:25:00Z","reference_number":"EMA/67145/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-23-26-may-2016_en.pdf"},
    {"id":"28897","name":"Revision of EMEA Financial Regulation as of 1 January 2009","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-01T00:09:21Z","last_updated_date":"2009-06-11T02:00:00Z","reference_number":"EMEA/MB/174828/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/revision-emea-financial-regulation-1-january-2009_en.pdf"},
    {"id":"28898","name":"CVMP post-authorisation summary of opinion for Nexgard Spectra (II/0008)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/CVMP/159285/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-opinion-nexgard-spectra-ii0008_en.pdf"},
    {"id":"28901","name":"Nanomedicine: Current view, present and future main regulatory challenges - Rogà©rio Gaspar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-29T02:09:21Z","last_updated_date":"2009-04-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/nanomedicine-current-view-present-and-future-main-regulatory-challenges-rogacrio-gaspar_en.pdf"},
    {"id":"28902","name":"Registration form - Workshop on immunogenicity assessment of biotechnology derived-therapeutic proteins with interested parties","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T13:30:00Z","last_updated_date":"2016-01-27T13:30:00Z","reference_number":"EMA/55161/2016","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-workshop-immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-interested-parties_en.doc"},
    {"id":"28904","name":"Press Release: Committee for Orphan Medicinal Products April 2007 Meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-04-16T02:09:21Z","last_updated_date":"2007-04-16T02:09:21Z","reference_number":"EMEA/COMP/142534/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-committee-orphan-medicinal-products-april-2007-meeting_en.pdf"},
    {"id":"28906","name":"European Medicines Agency Management Board elects Kent Woods as new chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-10T02:00:00Z","last_updated_date":"2011-06-10T02:00:00Z","reference_number":"EMA/451985/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-management-board-elects-kent-woods-new-chair_en.pdf"},
    {"id":"28909","name":"EU/3/17/1936: Public summary of opinion on orphan designation: 1-[4-Bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for the treatment of gastrointestinal stromal tum...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/689763/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171936-public-summary-opinion-orphan-designation-1-4-bromo-5-1-ethyl-7-methylamino-2-oxo-12-dihydro-16-naphthyridin-3-yl-2-fluorophenyl-3-phenylurea-treatment-gastrointestinal-stromal-tum_en.pdf"},
    {"id":"28910","name":"Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 4","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T17:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"EMA/926029/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-european-federation-pharmaceutical-industries-and-associations-modelling-and-simulation-workshop-break-out-session-4_en.pdf"},
    {"id":"28911","name":"Decision determining the start date of the term of office of the members of\n\nthe Management Board appointed by Council Decision No 2009/75/EC","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-03-05T00:09:21Z","last_updated_date":"2009-03-05T00:09:21Z","reference_number":"EMEA/MB/87076/2009Adopted","document_url":"https://www.ema.europa.eu/en/documents/other/decision-determining-start-date-term-office-members-management-board-appointed-council-decision-no-200975ec_en.pdf"},
    {"id":"28912","name":"Presentation - Implementation of new eligibility requirements (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-new-eligibility-requirements-nathalie-bere_en.pdf"},
    {"id":"28916","name":"Announcement of seminar on pre-clinical safety evaluation of vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-10-09T02:00:00Z","last_updated_date":"2000-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/announcement-seminar-pre-clinical-safety-evaluation-vaccines_en.pdf"},
    {"id":"28918","name":"Agenda: 2016 annual face to face meeting of the Enpr-EMA Coordinating Group members","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"EMA/204746/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2016-annual-face-face-meeting-enpr-ema-coordinating-group-members_en.pdf"},
    {"id":"28921","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12-15 December 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T14:50:00Z","last_updated_date":"2018-01-18T14:50:00Z","reference_number":"EMA/PDCO/844387/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-15-december-2017_en.pdf"},
    {"id":"28924","name":"EU/3/03/178: Public summary of positive opinion for orphan designation of sildenafil citrate for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:00:00Z","last_updated_date":"2016-01-20T00:00:00Z","reference_number":"EMEA/COMP/1572/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303178-public-summary-positive-opinion-orphan-designation-sildenafil-citrate-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"28925","name":"Presentation - Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (Sabine Brosch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-medical-literature-and-entry-relevant-information-eudravigilance-database-european-medicines-agency-sabine-brosch_en.pdf"},
    {"id":"28928","name":"Overview of comments on reflection paper on adaptogenic concept (EMEA/HMPC/598048/2007)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-05-08T02:00:00Z","last_updated_date":"2008-05-08T02:00:00Z","reference_number":"EMEA/HMPC/598048/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-reflection-paper-adaptogenic-concept-emeahmpc5980482007_en.pdf"},
    {"id":"28929","name":"Presentation - COMP update to the Patients' and Consumers' Working Party (Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comp-update-patients-and-consumers-working-party-daniel-oconnor_en.pdf"},
    {"id":"28930","name":"Presentation - Immunogenicity of biologicals: a pharmacovigilance perspective (Niels Vermeer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunogenicity-biologicals-pharmacovigilance-perspective-niels-vermeer_en.pdf"},
    {"id":"28931","name":"Ketoprofen - Article 107 referral - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoprofen-article-107-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ketoprofen-article-107-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ketoprofen-article-107-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ketoprofen-article-107-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ketoprofen-article-107-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ketoprofen-article-107-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ketoprofen-article-107-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ketoprofen-article-107-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ketoprofen-article-107-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ketoprofen-article-107-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ketoprofen-article-107-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ketoprofen-article-107-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ketoprofen-article-107-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ketoprofen-article-107-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ketoprofen-article-107-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ketoprofen-article-107-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ketoprofen-article-107-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ketoprofen-article-107-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ketoprofen-article-107-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ketoprofen-article-107-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ketoprofen-article-107-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ketoprofen-article-107-referral-annex-ii_sv.pdf"}},
    {"id":"28932","name":"Concept paper on the need to elaborate summary-of-product-characteristics guidance to minimise the development of anthelmintic resistance","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-10-14T02:09:21Z","last_updated_date":"2008-10-14T02:09:21Z","reference_number":"EMEA/CVMP/638/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-elaborate-summary-product-characteristics-guidance-minimise-development-anthelmintic-resistance_en.pdf"},
    {"id":"28935","name":"Draft guideline on ICH Considerations - Oncolytic viruses","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"CHMP/GTWP/607698/08","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-ich-considerations-oncolytic-viruses_en.pdf"},
    {"id":"28939","name":"Sabumalin - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-03-30T02:08:21Z","last_updated_date":"2009-03-30T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sabumalin-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"28940","name":"Goserelin: List of nationally authorised medicinal products - PSUSA/00001562/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-24T11:30:00Z","last_updated_date":"2017-01-24T11:37:33Z","reference_number":"EMA/45363/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/goserelin-list-nationally-authorised-medicinal-products-psusa00001562201605_en.pdf"},
    {"id":"28943","name":"CHMP summary of positive opinion for Trajenta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/450821/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trajenta_en.pdf"},
    {"id":"28945","name":"CHMP summary of positive opinion for Otezla","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2014-11-21T13:00:00Z","reference_number":"EMA/CHMP/490023/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-otezla_en.pdf"},
    {"id":"28947","name":"Committee on herbal medicinal products (HMPC): Meeting report, 2-3 July 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-07-15T02:00:00Z","last_updated_date":"2009-07-15T02:00:00Z","reference_number":"EMEA/HMPC/369359/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-2-3-july-2008_en.pdf"},
    {"id":"28949","name":"Outcome of the public consultation on the Reflection paper on PRIME","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2016-03-07T12:00:00Z","reference_number":"EMA/132593/2016","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-public-consultation-reflection-paper-prime_en.pdf"},
    {"id":"28950","name":"European Medicines Agency recommends contraindication for Regranex in patients with any pre-existing cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-02-18T01:00:00Z","last_updated_date":"2010-02-18T01:00:00Z","reference_number":"EMA/92326/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-contraindication-regranex-patients-any-pre-existing-cancer_en.pdf"},
    {"id":"28952","name":"Presentation - MPS – development status, first industrial adoption and current challenges (U. Marx)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T11:22:00Z","last_updated_date":"2017-11-15T11:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mps-development-status-first-industrial-adoption-and-current-challenges-u-marx_en.pdf"},
    {"id":"28955","name":"Factor VIII Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2017-07-27T19:30:00Z","reference_number":"EMA/PRAC/471536/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"28956","name":"Annual list of contractors 2016 - contract values: €15,000 to €134,999","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-28T17:00:00Z","last_updated_date":"2017-06-28T17:00:00Z","reference_number":"EMA/369495/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annual-list-contractors-2016-contract-values-eu15000-eu134999_en.pdf"},
    {"id":"28960","name":"EU/3/01/071: Public summary of positive opinion for orphan designation of stiripentol for the treatment of severe myoclonic epilepsy in infancy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-31T02:00:00Z","last_updated_date":"2017-02-08T01:00:00Z","reference_number":"EMEA/COMP/269/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301071-public-summary-positive-opinion-orphan-designation-stiripentol-treatment-severe-myoclonic-epilepsy-infancy_en.pdf"},
    {"id":"28961","name":"Call for submission of scientific data relating to the assessment of  Matricariae flos; Matricaria recutita L. (Chamomilla recutita (L.) Rauschert), flos (Matricaria flower)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-08-15T02:00:00Z","last_updated_date":"2009-08-15T02:00:00Z","reference_number":"EMEA/HMPC/468689/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-matricariae-flos-matricaria-recutita-l-chamomilla-recutita-l-rauschert-flos-matricaria-flower_en.pdf"},
    {"id":"28963","name":"Kristian Svendsen  (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/kristian-svendsen-doi_en.pdf"},
    {"id":"28964","name":"Presentation - Industry perspective on public–private partnerships and the link between new business models and the regulatory framework (John H. Rex)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-public-private-partnerships-and-link-between-new-business-models-and-regulatory-framework-john-h-rex_en.pdf"},
    {"id":"28965","name":"Agenda and registration form - Information day on the new identification of medicinal products (IDMP) international standards and International Conference on Harmonisation (ICH) M5/M2, and implementation of electronic su...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-07-01T17:22:22Z","last_updated_date":"2011-07-01T17:22:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-information-day-new-identification-medicinal-products-idmp-international-standards-and-international-conference-harmonisation-ich-m5m2-and-implementation-electronic-su_en.pdf"},
    {"id":"28966","name":"Ad hoc CHMP Expert Group Meeting on 'Nanomedicines' - 29th April 2009","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-07-10T02:09:21Z","last_updated_date":"2009-07-10T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/ad-hoc-chmp-expert-group-meeting-nanomedicines-29th-april-2009_en.pdf"},
    {"id":"28967","name":"Betaine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-09-01T02:00:00Z","last_updated_date":"1997-09-01T02:00:00Z","reference_number":"EMEA/MRL/261/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/betaine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"28968","name":"Overview of comments received on 'Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products’\n\n(EMA/CVMP/IWP/37620/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-09-17T18:28:01Z","last_updated_date":"2015-09-17T18:28:01Z","reference_number":"EMA/CVMP/IWP/254498/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-replacement-cell-lines-used-production-immunological-veterinary-medicinal-products-emacvmpiwp376202014_en.pdf"},
    {"id":"28970","name":"Presentation - Strengthening collaborations for operating pharmacovigilance in Europe (SCOPE) (Paul Barrow)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-collaborations-operating-pharmacovigilance-europe-scope-paul-barrow_en.pdf"},
    {"id":"28974","name":"Primula root: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-10-06T02:00:00Z","last_updated_date":"2016-10-06T02:00:00Z","reference_number":"EMA/424238/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/primula-root-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/primula-root-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/primula-root-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/primula-root-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/primula-root-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/primula-root-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/primula-root-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/primula-root-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/primula-root-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/primula-root-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/primula-root-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/primula-root-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/primula-root-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/primula-root-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/primula-root-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/primula-root-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/primula-root-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/primula-root-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/primula-root-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/primula-root-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/primula-root-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/primula-root-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/primula-root-summary-public_sv.pdf"}},
    {"id":"28976","name":"Presentation - Risk-benefit communication: managing media channels (Monika Benstetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-benefit-communication-managing-media-channels-monika-benstetter_en.pdf"},
    {"id":"28977","name":"European Medicines Agency statement on recent publication on cardiac safety of rosiglitazone (Avandia, Avandamet, Avaglim)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-05-23T02:00:00Z","last_updated_date":"2007-05-23T02:00:00Z","reference_number":"EMEA/230057/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-statement-recent-publication-cardiac-safety-rosiglitazone-avandia-avandamet-avaglim_en.pdf"},
    {"id":"28978","name":"Iffeza - Article 29 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T02:00:00Z","last_updated_date":"2012-10-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/iffeza-article-29-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/iffeza-article-29-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/iffeza-article-29-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/iffeza-article-29-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/iffeza-article-29-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/iffeza-article-29-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/iffeza-article-29-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/iffeza-article-29-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/iffeza-article-29-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/iffeza-article-29-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/iffeza-article-29-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/iffeza-article-29-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/iffeza-article-29-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/iffeza-article-29-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/iffeza-article-29-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/iffeza-article-29-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/iffeza-article-29-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/iffeza-article-29-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/iffeza-article-29-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/iffeza-article-29-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/iffeza-article-29-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/iffeza-article-29-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/iffeza-article-29-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/iffeza-article-29-referral-annex-iii_no.pdf"}},
    {"id":"28980","name":"Diacerein Article-31 referral - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-19T02:00:00Z","last_updated_date":"2014-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-cmdh-divergent-position_en.pdf"},
    {"id":"28982","name":"Event flier: European Medicines Agency scientific debate","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-08-09T02:00:00Z","last_updated_date":"2010-08-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/event-flier-european-medicines-agency-scientific-debate_en.pdf"},
    {"id":"28983","name":"List of references for assessment of: Thymi aetheroleum Thymus vulgaris L.; Thymus zygis L., aetheroleum (thyme essential oil)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2009-05-14T02:09:21Z","reference_number":"EMEA/HMPC/131905/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-assessment-thymi-aetheroleum-thymus-vulgaris-l-thymus-zygis-l-aetheroleum-thyme-essential-oil_en.pdf"},
    {"id":"28984","name":"Meprobamate - Article 107 referral - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-06-08T16:15:00Z","last_updated_date":"2012-06-08T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/meprobamate-article-107-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/meprobamate-article-107-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/meprobamate-article-107-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/meprobamate-article-107-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/meprobamate-article-107-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/meprobamate-article-107-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/meprobamate-article-107-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/meprobamate-article-107-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/meprobamate-article-107-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/meprobamate-article-107-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/meprobamate-article-107-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/meprobamate-article-107-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/meprobamate-article-107-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/meprobamate-article-107-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/meprobamate-article-107-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/meprobamate-article-107-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/meprobamate-article-107-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/meprobamate-article-107-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/meprobamate-article-107-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/meprobamate-article-107-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/meprobamate-article-107-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/meprobamate-article-107-referral-annex-ii_sv.pdf"}},
    {"id":"28986","name":"Presentation - Governance and SPOR TF ToR","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T17:00:00Z","last_updated_date":"2017-12-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-governance-and-spor-tf-tor_en.pdf"},
    {"id":"28988","name":"Guideline on follow-up of patients administered with gene therapy medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-11-13T00:09:21Z","last_updated_date":"2009-11-13T00:09:21Z","reference_number":"EMEA/CHMP/GTWP/60436/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-follow-patients-administered-gene-therapy-medicinal-products_en.pdf"},
    {"id":"28989","name":"Presentation - Functional outcome measures for type 2 and 3 Spinal Muscular Atrophy (Anna Mayhew, Jacqueline Montes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T01:00:00Z","last_updated_date":"2016-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-functional-outcome-measures-type-2-and-3-spinal-muscular-atrophy-anna-mayhew-jacqueline-montes_en.pdf"},
    {"id":"28990","name":"Agenda - Workshop programme - Pre- and post-authorisation regulatory support for micro, small and medium-sized enterprises","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-05-06T02:00:00Z","reference_number":"EMA/214813/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-programme-pre-and-post-authorisation-regulatory-support-micro-small-and-medium-sized-enterprises_en.pdf"},
    {"id":"28991","name":"Final list of references supporting the assessment of Humulus lupulus L., flos - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-08-07T02:00:00Z","last_updated_date":"2014-08-07T02:00:00Z","reference_number":"EMA/HMPC/682386/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"28992","name":"Summary of the EMA public hearing on quinolone and fluoroquinolone antibiotics","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-20T14:30:00Z","last_updated_date":"2018-07-12T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_bg.pdf","es":"https://www.ema.europa.eu/es/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_cs.pdf","da":"https://www.ema.europa.eu/da/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_da.pdf","de":"https://www.ema.europa.eu/de/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_de.pdf","et":"https://www.ema.europa.eu/et/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_et.pdf","el":"https://www.ema.europa.eu/el/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_hr.pdf","it":"https://www.ema.europa.eu/it/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/report/summary-ema-public-hearing-quinolone-and-fluoroquinolone-antibiotics_sv.pdf"}},
    {"id":"28996","name":"Draft community herbal monograph on Primula veris L., Primula elatior (L.) Hill, radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-03-08T01:00:00Z","last_updated_date":"2007-03-08T01:00:00Z","reference_number":"MEA/HMPC/143370/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-primula-veris-l-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"29004","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 February 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-02-17T01:00:00Z","last_updated_date":"2017-02-17T01:00:00Z","reference_number":"EMA/CVMP/72976/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-february-2017_en.pdf"},
    {"id":"29006","name":"Overview of comments received on ‘Guideline on the adventitious agent safety of urine-derived medicinal products’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-05-29T12:00:00Z","last_updated_date":"2015-05-29T12:00:00Z","reference_number":"EMA/CHMP/BWP/248233/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-adventitious-agent-safety-urine-derived-medicinal-products_en.pdf"},
    {"id":"29008","name":"Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance Non-clinical and clinical issues (Replaced by CHMP/BMWP/101695/06)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-12-17T01:00:00Z","last_updated_date":"2003-12-17T01:00:00Z","reference_number":"EMEA/CPMP/3097/02/Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-comparability-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-replaced-chmpbmwp10169506_en.pdf"},
    {"id":"29011","name":"Presentation - EU IDMP/SPOR Task Force meeting: Referentials Management Services (RMS) (6. agenda) (Jaume Nogueras)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-idmpspor-task-force-meeting-referentials-management-services-rms-6-agenda-jaume-nogueras_en.pdf"},
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    {"id":"29052","name":"Overview of comments received on draft guideline on the acceptability of names for veterinary medicinal products processed through the centralised procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-21T01:00:00Z","last_updated_date":"2008-01-21T01:00:00Z","reference_number":"EMEA/CVMP/532811/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-acceptability-names-veterinary-medicinal-products-processed-through-centralised-procedure_en.pdf"},
    {"id":"29053","name":"Update on product shortages due to manufacturing/GMP and quality issues (Brendan Cuddy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-01T02:00:00Z","last_updated_date":"2015-09-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/update-product-shortages-due-manufacturinggmp-and-quality-issues-brendan-cuddy_en.pdf"},
    {"id":"29054","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - March 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-03-28T02:00:00Z","last_updated_date":"2011-03-28T02:00:00Z","reference_number":"EMA/CVMP/37837/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-march-2011_en.pdf"},
    {"id":"29057","name":"Opinion following an Article 30 referral for Efexor and associated names International Non-Proprietary Name (INN): venlafaxine: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-12-03T00:08:21Z","last_updated_date":"2008-12-03T00:08:21Z","reference_number":"EMEA/CHMP/384875/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-30-referral-efexor-and-associated-names-international-non-proprietary-name-inn-venlafaxine-background-information_sv.pdf"}},
    {"id":"29059","name":"Leflunomide Apotex Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/leflunomide-apotex-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"29061","name":"List of participants - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T17:00:00Z","last_updated_date":"2013-07-02T17:00:00Z","reference_number":"EMA/263314/2013","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting_en.pdf-0"},
    {"id":"29062","name":"EU/3/03/134: Public summary of  positive opinion for orphan designation  of  iodine (123I) serum amyloid P  for the diagnosis of the extent of histologically proven amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2016-08-10T02:00:00Z","reference_number":"EMEA/COMP/126/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303134-public-summary-positive-opinion-orphan-designation-iodine-123i-serum-amyloid-p-diagnosis-extent-histologically-proven-amyloidosis_en.pdf"},
    {"id":"29068","name":"EU/3/08/548: Public summary of positive opinion for orphan designation of\n\ncarfilzomib for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2014-07-11T02:00:00Z","reference_number":"EMEA/COMP/196439/2008 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308548-public-summary-positive-opinion-orphan-designation-carfilzomib-treatment-multiple-myeloma_en.pdf"},
    {"id":"29071","name":"CHMP post-authorisation summary of positive opinion for Byetta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2010-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-byetta_en.pdf-0"},
    {"id":"29073","name":"EU/3/17/1933: Public summary of opinion on orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione for the treatment of systemic scler...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/676126/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171933-public-summary-opinion-orphan-designation-1r6r-3-benzylamine-6-hydroxy-3-methyl-4-pentyl-6-prop-1-en-2-yl-11-bicyclohexane-236-triene-25-dione-treatment-systemic-scler_en.pdf"},
    {"id":"29074","name":"EU/3/06/423: Public summary of positive opinion for orphan designation of tazarotene for the treatment of congenital ichthyoses","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMEA/COMP/495692/2006 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306423-public-summary-positive-opinion-orphan-designation-tazarotene-treatment-congenital-ichthyoses_en.pdf"},
    {"id":"29076","name":"EU/3/12/1093: Public summary of opinion on orphan designation: 1,2:5,6-Dianhydrogalactitol for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/848/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121093-public-summary-opinion-orphan-designation-1256-dianhydrogalactitol-treatment-glioma_en.pdf"},
    {"id":"29079","name":"Public statement on Trudexa (adalimumab) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-07-26T02:09:21Z","last_updated_date":"2007-07-26T02:09:21Z","reference_number":"EMEA/CHMP/285833/2007","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-trudexa-adalimumab-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"29082","name":"Recommendation to marketing authorisation holders, highlighting recent updates for reduction, refinement and replacement (3Rs) methods described in the European Pharmacopoeia applicable to human vaccines against hepatiti...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-07-20T13:25:00Z","last_updated_date":"2015-07-20T13:25:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/243112/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-marketing-authorisation-holders-highlighting-recent-updates-reduction-refinement-and-replacement-3rs-methods-described-european-pharmacopoeia-applicable-human-vaccines-against-hepatiti_en.pdf"},
    {"id":"29083","name":"Committee for medicinal products for human use, summary of positive opinion for Resolor","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/449050/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-resolor_en.pdf"},
    {"id":"29084","name":"Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-07T18:10:00Z","last_updated_date":"2019-11-04T12:31:00Z","reference_number":"EMA/254278/2014 Rev.3.1","document_url":"https://www.ema.europa.eu/en/documents/other/changes-some-business-rules-extended-eudravigilance-medicinal-product-dictionary-xevmpd-submission-substance-information_en.pdf"},
    {"id":"29085","name":"Flupirtine: List of nationally authorised medicinal products - PSUSA/00010225/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-20T18:14:00Z","last_updated_date":"2018-06-20T18:16:26Z","reference_number":"EMA/417850/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/flupirtine-list-nationally-authorised-medicinal-products-psusa00010225201710_en.pdf"},
    {"id":"29087","name":"European Medicines Agency recommends suspension of all buflomedil-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-17T16:56:24Z","last_updated_date":"2011-11-17T16:56:24Z","reference_number":"EMA/CHMP/570796/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-all-buflomedil-containing-medicines_en.pdf"},
    {"id":"29088","name":"Presentation - Extrapolation in antibacterial agents (I. Lutsar, M. Fernandez Cortizo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-extrapolation-antibacterial-agents-i-lutsar-m-fernandez-cortizo_en.pdf"},
    {"id":"29090","name":"Presentation - Alternative methods in risk assessment and kinetics in paediatric pharmacology: A common need for physiologically based pharmacokinetic modelling","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-alternative-methods-risk-assessment-and-kinetics-paediatric-pharmacology-common-need-physiologically-based-pharmacokinetic-modelling_en.pdf"},
    {"id":"29092","name":"Draft programme - Paediatric strategy forum for medicinal product development for mature B cell malignancies in children","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-01T17:53:00Z","last_updated_date":"2017-11-14T17:27:00Z","reference_number":"EMA/341363/2017","document_url":"https://www.ema.europa.eu/en/documents/other/draft-programme-paediatric-strategy-forum-medicinal-product-development-mature-b-cell-malignancies-children_en.pdf"},
    {"id":"29093","name":"Scientific recommendation on classification of advanced therapy medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-12-14T15:30:00Z","last_updated_date":"2011-12-14T15:30:00Z","reference_number":"EMA/963488/2011","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"29095","name":"Final community herbal monograph on Arctium lappa L., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2011-04-14T02:00:00Z","reference_number":"EMA/HMPC/246763/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-arctium-lappa-l-radix_en.pdf"},
    {"id":"29096","name":"European Medicines Agency guidance for companies requesting scientific advice (veterinary)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-03-01T01:00:00Z","last_updated_date":"2020-10-19T11:00:00Z","reference_number":"EMA/CVMP/11887/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-guidance-companies-requesting-scientific-advice-veterinary_en.pdf"},
    {"id":"29097","name":"Opinions on safety variations / periodic safety update reports adopted at the CHMP meeting of 21-24 July 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-29T18:15:00Z","last_updated_date":"2014-07-29T18:15:00Z","reference_number":"EMA/125407/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-periodic-safety-update-reports-adopted-chmp-meeting-21-24-july-2014_en.pdf"},
    {"id":"29099","name":"European and international experts discuss the way forward in developing ophthalmology medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-04T13:08:27Z","last_updated_date":"2011-11-04T13:08:27Z","reference_number":"EMA/871844/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-and-international-experts-discuss-way-forward-developing-ophthalmology-medicines_en.pdf"},
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    {"id":"29109","name":"CHMP summary of positive opinion for Sylvant","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/CHMP/142794/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sylvant_en.pdf"},
    {"id":"29110","name":"Hydroxyethyl starch Article-107i referral - CMDh endorses PRAC recommendation","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T01:00:00Z","last_updated_date":"2018-02-02T01:00:00Z","reference_number":"EMA/35795/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-cmdh-endorses-prac-recommendation_en.pdf"},
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    {"id":"29117","name":"Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis: List of nationally authorised medicinal products - PSUSA/00010465/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T16:00:00Z","last_updated_date":"2017-09-08T16:00:00Z","reference_number":"EMA/596847/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-therapy-dactylis-glomerata-l-phleum-pratense-l-anthoxanthum-odoratum-l-lolium-perenne-l-poa-pratensis-list-nationally-authorised-medicinal-products-psusa00010465201612_en.pdf"},
    {"id":"29118","name":"CHMP post-authorisation summary of positive opinion for Gilenya","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T14:00:00Z","last_updated_date":"2015-09-25T14:00:00Z","reference_number":"EMA/CHMP/627232/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-gilenya_en.pdf-0"},
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    {"id":"29120","name":"Draft community herbal monograph on Pimpinella anisum L., fructus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-09-15T02:09:21Z","last_updated_date":"2006-09-15T02:09:21Z","reference_number":"EMEA/HMPC/137423/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-pimpinella-anisum-l-fructus_en.pdf"},
    {"id":"29121","name":"Summary of transfer of appropriations in the budget 2013 - Management Board meeting: 19-20 March 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-25T13:30:00Z","last_updated_date":"2014-03-25T13:30:00Z","reference_number":"EMA/MB/85740/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2013-management-board-meeting-19-20-march-2014_en.pdf"},
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    {"id":"29180","name":"Presentation - Integration of multiple biomarkers, translation to surrogate / outcomes and their application in early drug development – A case study to support phase IIa design - Break-out session 1 theme 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:45:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-integration-multiple-biomarkers-translation-surrogate-outcomes-and-their-application-early-drug-development-case-study-support-phase-iia-design-break-out-session-1-theme-3_en.pdf"},
    {"id":"29182","name":"Lisdexamfetamine : List of nationally authorised medicinal products -   PSUSA/00010289/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-29T19:06:00Z","last_updated_date":"2017-09-29T19:07:58Z","reference_number":"EMA/639185/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/lisdexamfetamine-list-nationally-authorised-medicinal-products-psusa00010289201702_en.pdf"},
    {"id":"29183","name":"Committee for Orphan Medicinal Products: April 2006 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-04-06T02:00:00Z","last_updated_date":"2006-04-06T02:00:00Z","reference_number":"EMEA/COMP/125572/2006Rev1","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-april-2006-meeting_en.pdf"},
    {"id":"29184","name":"EU/3/10/822: Public summary of opinion on orphan designation: Lentiviral vector carrying the Fanconi anaemia-A (FANCA) gene for the treatment of Fanconi anaemia type A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/COMP/662962/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310822-public-summary-opinion-orphan-designation-lentiviral-vector-carrying-fanconi-anaemia-fanca-gene-treatment-fanconi-anaemia-type_en.pdf"},
    {"id":"29188","name":"SONOVUE (sulphur hexafluoride): New contraindication in patients with heart disease. Restriction of use to non-cardiac imaging","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-05-20T01:31:00Z","last_updated_date":"2004-05-20T01:31:00Z","reference_number":"EMEA/CPMP/212_04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/sonovue-sulphur-hexafluoride-new-contraindication-patients-heart-disease-restriction-use-non-cardiac-imaging_en.pdf"},
    {"id":"29189","name":"European Medicines Agency / PDCO standard paediatric investigation plan for allergen products for specific immunotherapy","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-11-24T00:09:21Z","last_updated_date":"2015-03-09T14:55:00Z","reference_number":"EMEA/737605/2009 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pdco-standard-paediatric-investigation-plan-allergen-products-specific-immunotherapy_en.pdf"},
    {"id":"29191","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 15-18 December 2014","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-01-08T16:15:00Z","last_updated_date":"2015-01-08T16:15:00Z","reference_number":"EMA/129897/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-15-18-december-2014_en.pdf"},
    {"id":"29192","name":"Minutes of the 76th meeting of the Management Board: 7 June 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-09-12T12:30:00Z","last_updated_date":"2012-09-12T12:30:00Z","reference_number":"EMA/MB/394635/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-76th-meeting-management-board-7-june-2012_en.pdf"},
    {"id":"29193","name":"Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2016-03-03T16:03:00Z","reference_number":"EMA/618604/2008 Rev. 13","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-positions-specific-questions-addressed-pharmacokinetics-working-party_en.pdf"},
    {"id":"29194","name":"Generics - Hybrids - Day 80 assessment report - Non-clinical and clinical template with guidance - Rev. 05. 21","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-07-08T15:20:00Z","last_updated_date":"2021-06-25T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/generics-hybrids-day-80-assessment-report-non-clinical-and-clinical-template-guidance-rev-05-21_en.docx"},
    {"id":"29197","name":"CHMP summary of positive opinion for Mermatine Merz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/589593/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mermatine-merz_en.pdf"},
    {"id":"29198","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12-14 June 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-06-27T12:00:00Z","last_updated_date":"2013-06-27T12:00:00Z","reference_number":"EMA/356485/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-14-june-2013_en.pdf"},
    {"id":"29199","name":"EU/3/03/161: Public summary of positive opinion for orphan designation of antisense oligonucleotide (TATCCGGAGGGCTCGCCATGCTGCT) for treatment of  neovascular glaucoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-04-26T02:00:00Z","last_updated_date":"2004-04-26T02:00:00Z","reference_number":"EMEA/COMP/1421/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303161-public-summary-positive-opinion-orphan-designation-antisense-oligonucleotide-tatccggagggctcgccatgctgct-treatment-neovascular-glaucoma_en.pdf"},
    {"id":"29201","name":"ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients – questions and answers - Step 5","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T13:00:00Z","last_updated_date":"2015-08-04T13:00:00Z","reference_number":"EMA/CHMP/ICH/82260/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-questions-and-answers-step-5_en.pdf"},
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    {"id":"29242","name":"Draft community herbal monograph on Humulus lupulus L., flos - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2007-07-05T02:00:00Z","reference_number":"EMEA/HMPC/513617/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-humulus-lupulus-l-flos-first-version_en.pdf"},
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    {"id":"29280","name":"EU/3/18/1999: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX cDNA for the treatment of haemophilia ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"EMA/139261/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181999-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-containing-codon-optimized-padua-derivative-human-coagulation-factor-ix-cdna-treatment-haemophilia_en.pdf"},
    {"id":"29283","name":"Presentation - Traditional validation: Downstream (Norbert Hentschel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-traditional-validation-downstream-norbert-hentschel_en.pdf"},
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    {"id":"29285","name":"Diacerein Article-31 referral - PRAC assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-19T02:00:00Z","last_updated_date":"2014-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"29287","name":"Committee for proprietary medicinal products May 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-06-06T02:00:00Z","last_updated_date":"2002-06-06T02:00:00Z","reference_number":"EMEA/CPMP/2222/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-may-2002-plenary-meeting-monthly-report_en.pdf"},
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    {"id":"29300","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the seventy seventh meeting of the committee for veterinary medicinal products took place in London on 14 - 16 May 2002.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-05-17T14:09:21Z","last_updated_date":"2002-05-17T14:09:21Z","reference_number":"EMEA/CVMP/511/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-seventy-seventh-meeting-committee-veterinary-medicinal-products-took-place-london-14-16-may-2002_en.pdf"},
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    {"id":"29304","name":"EU/3/14/1297: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against antithrombin mRNA and covalently linked to a ligand containing three N-acetylgalactosamine r...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T17:30:00Z","last_updated_date":"2014-09-01T17:30:00Z","reference_number":"EMA/COMP/360847/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141297-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-antithrombin-mrna-and-covalently-linked-ligand-containing-three-n_en.pdf"},
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    {"id":"29312","name":"EU/3/11/936: Public summary of opinion on orphan designation: Human haptoglobin for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/COMP/845929/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311936-public-summary-opinion-orphan-designation-human-haptoglobin-treatment-sickle-cell-disease_en.pdf"},
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    {"id":"29357","name":"EU/3/16/1624: Public summary of opinion on orphan designation: Acalabrutinib for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2016-05-02T02:00:00Z","reference_number":"EMA/COMP/153504/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161624-public-summary-opinion-orphan-designation-acalabrutinib-treatment-chronic-lymphocytic-leukaemia-small-lymphocytic-lymphoma_en.pdf"},
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    {"id":"29361","name":"Public statement on Allex (desloratadine): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-05-19T02:09:21Z","last_updated_date":"2004-05-19T02:09:21Z","reference_number":"EMEA/10089/04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-allex-desloratadine-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"29364","name":"CHMP post-authorisation summary of positive opinion for Icandra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/600950/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-icandra_en.pdf"},
    {"id":"29365","name":"List of participants – RD-ACTION, European Medicines Agency, and European Commission-DG SANTE workshop: how European Reference Networks can add value to clinical research","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T18:45:00Z","last_updated_date":"2018-06-19T18:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-rd-action-european-medicines-agency-and-european-commission-dg-sante-workshop-how-european-reference-networks-can-add-value-clinical-research_en.pdf"},
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    {"id":"29418","name":"List of participants - Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T12:00:00Z","last_updated_date":"2016-01-07T12:00:00Z","reference_number":"EMA/772047/2015","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-workshop-role-pharmacokinetic-and-pharmacodynamic-measurements-use-direct-oral-anticoagulants_en.pdf"},
    {"id":"29419","name":"EU/03/14/1269: Public summary of opinion on orphan designation of lutetium (177Lu) edotreotide for the treatment of gastro-entero-pancreatic neuroendocrine tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/258942/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu03141269-public-summary-opinion-orphan-designation-lutetium-177lu-edotreotide-treatment-gastro-entero-pancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"29420","name":"EMEA meeting with interested parties and research centres on ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) - List of Participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T01:00:00Z","last_updated_date":"2007-12-14T01:00:00Z","reference_number":"EMEA/598470/2007","document_url":"https://www.ema.europa.eu/en/documents/other/emea-meeting-interested-parties-and-research-centres-encepp-european-network-centres-pharmacoepidemiology-and-pharmacovigilance-list-participants_en.pdf"},
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    {"id":"29423","name":"EU/3/03/149: Public summary of positive opinion for orphan designation of cytochrome P450 isoform 2B1 gene transfected human embryonic kidney 293 cells encapsulated in polymeric cellulose sulphate for the treatment of pa...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2009-09-21T02:00:00Z","reference_number":"EMEA/COMP/1194/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303149-public-summary-positive-opinion-orphan-designation-cytochrome-p450-isoform-2b1-gene-transfected-human-embryonic-kidney-293-cells-encapsulated-polymeric-cellulose-sulphate-treatment-pa_en.pdf"},
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    {"id":"29429","name":"EU/3/10/846: Public summary of opinion on orphan designation: Paclitaxel (aqueous gel) for the treatment of oesophagus carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2011-03-04T01:00:00Z","reference_number":"EMA/COMP/16280/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310846-public-summary-opinion-orphan-designation-paclitaxel-aqueous-gel-treatment-oesophagus-carcinoma_en.pdf"},
    {"id":"29430","name":"Cefoperazone / sulbactam: List of nationally authorised medicinal products - PSUSA/00000598/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T12:19:00Z","last_updated_date":"2016-10-27T12:24:03Z","reference_number":"EMA/714629/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefoperazone-sulbactam-list-nationally-authorised-medicinal-products-psusa00000598201601_en.pdf-0"},
    {"id":"29432","name":"CHMP post authorisation summary of positive opinion for Yondelis on 24 September 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/CHMP/608550/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yondelis-24-september-2009_en.pdf"},
    {"id":"29433","name":"Agenda - CAT agenda of the 10-12 April 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-04-11T18:16:00Z","last_updated_date":"2017-04-11T18:16:00Z","reference_number":"EMA/CAT/242785/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-10-12-april-2017-meeting_en.pdf"},
    {"id":"29434","name":"EU/3/02/128: Public summary of positive opinion for orphan designation of carboxypeptidase G2 for the adjunctive treatment in patients at risk of methotrexate toxicity","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2015-05-14T01:00:00Z","reference_number":"EMEA/COMP/32880/02 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302128-public-summary-positive-opinion-orphan-designation-carboxypeptidase-g2-adjunctive-treatment-patients-risk-methotrexate-toxicity_en.pdf"},
    {"id":"29436","name":"Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T12:58:00Z","last_updated_date":"2016-11-15T13:01:22Z","reference_number":"EMA/751331/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa00001744201603_en.pdf"},
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    {"id":"29468","name":"Draft list of references for assessment of Rosmarini aetheroleum; Rosmarini folium Rosmarinus officinalis L., aetheroleum; Rosmarinus officinalis L., folium (rosemary oil; rosemary leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/13632/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-rosmarini-aetheroleum-rosmarini-folium-rosmarinus-officinalis-l-aetheroleum-rosmarinus-officinalis-l-folium-rosemary-oil-rosemary-leaf_en.pdf"},
    {"id":"29469","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: December 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T15:30:00Z","last_updated_date":"2017-01-23T15:30:00Z","reference_number":"EMA/872789/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-december-2016_en.pdf"},
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    {"id":"29471","name":"Presentation - Agreed PIPs for FDCs for the treatment of HIV-1 infection (Andrea Ecker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-05T17:00:00Z","last_updated_date":"2016-01-05T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agreed-pips-fdcs-treatment-hiv-1-infection-andrea-ecker_en.pdf"},
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    {"id":"29483","name":"CHMP post-authorisation summary of positive opinion for Kyprolis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/340832/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kyprolis_en.pdf"},
    {"id":"29488","name":"Nabumetone: List of nationally authorised medicinal products - PSUSA/00002101/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-06T17:30:00Z","last_updated_date":"2017-11-06T17:53:44Z","reference_number":"EMA/727925/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/nabumetone-list-nationally-authorised-medicinal-products-psusa00002101201703_en.pdf"},
    {"id":"29489","name":"Guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-09-29T12:00:01Z","last_updated_date":"2016-09-29T12:00:01Z","reference_number":"EMA/CHMP/BPWP/29205/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-human-anti-d-immunoglobulin-intramuscular-use_en.pdf"},
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    {"id":"29493","name":"Presentation - Interchangeability of generics","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interchangeability-generics_en.pdf"},
    {"id":"29494","name":"Questions and Answers on allogenic stem cell-based products for veterinary use: specific questions on sterility","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-06-23T17:00:00Z","last_updated_date":"2017-06-23T17:00:00Z","reference_number":"EMA/CVMP/ADVENT/751229/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-allogenic-stem-cell-based-products-veterinary-use-specific-questions-sterility_en.pdf"},
    {"id":"29495","name":"EU/3/15/1433: Public summary of opinion on orphan designation: Sevuparin sodium for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-08T02:00:00Z","last_updated_date":"2015-04-08T02:00:00Z","reference_number":"EMA/COMP/48629/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151433-public-summary-opinion-orphan-designation-sevuparin-sodium-treatment-sickle-cell-disease_en.pdf"},
    {"id":"29497","name":"Work instructions for EU-RMP annex 1: validation","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"WIN/H/3292","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-eu-rmp-annex-1-validation_en.pdf"},
    {"id":"29498","name":"Presentation - Antimicrobial resistance in food safety perspective - current situation in Croatia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antimicrobial-resistance-food-safety-perspective-current-situation-croatia_en.pdf"},
    {"id":"29499","name":"Minutes of the 94th meeting of the Management Board: 14-15 December 2016","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-02-07T18:00:00Z","last_updated_date":"2017-02-07T18:00:00Z","reference_number":"EMA/MB/862367/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-94th-meeting-management-board-14-15-december-2016_en.pdf"},
    {"id":"29500","name":"EU/3/12/1001: Public summary of opinion on orphan designation: 1-(4-{4-amino-7-[1-(2-hydroxyethyl)-1H-pyrazol-4-yl] thieno [3,2-c]pyridin-3-yl}phenyl)-3-(3-fluorophenyl) urea for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2015-06-08T14:30:00Z","reference_number":"EMA/COMP/280092/2012 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121001-public-summary-opinion-orphan-designation-1-4-4-amino-7-1-2-hydroxyethyl-1h-pyrazol-4-yl-thieno-32-cpyridin-3-ylphenyl-3-3-fluorophenyl-urea-treatment-ovarian-cancer_en.pdf"},
    {"id":"29501","name":"Early access to medicines - Development support and regulatory tools","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T18:30:00Z","last_updated_date":"2016-11-08T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/early-access-medicines-development-support-and-regulatory-tools_en.pdf"},
    {"id":"29503","name":"Meloxicam (Extension to bovine milk): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/635/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/meloxicam-extension-bovine-milk-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"29505","name":"Presentation - Patients' and families' priorities: Gaucher disease (Tanya Collin-Histed)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-28T01:00:00Z","last_updated_date":"2012-11-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-and-families-priorities-gaucher-disease-tanya-collin-histed_en.pdf"},
    {"id":"29507","name":"Lormetazepam: CMDh scientific conclusions and grounds for variation,\n\namendments to the product information and timetable for\n\nthe implementation - PSUSA/00001910/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-09T01:00:00Z","last_updated_date":"2016-10-18T10:40:07Z","reference_number":"EMA/739294/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/lormetazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001910201412_en.pdf"},
    {"id":"29508","name":"Studies assessed by the EMEA indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:09:21Z","last_updated_date":"2008-07-24T02:09:21Z","reference_number":"EMEA/CHMP/382256/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/studies-assessed-emea-indicate-no-increased-risk-developing-cancer-patients-who-have-taken-viracept-contaminated-ethyl-mesilate_en.pdf"},
    {"id":"29510","name":"Minutes of the audiovisual-open-tender site visit (supply, installation and maintenance of audiovisual equipment and consumables including on-site technical support - EMA/2012/21/IS)","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-11-28T16:07:00Z","last_updated_date":"2012-11-28T16:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-audiovisual-open-tender-site-visit-supply-installation-and-maintenance-audiovisual-equipment-and-consumables-including-site-technical-support-ema201221is_en.pdf"},
    {"id":"29511","name":"CHMP post-authorisation summary of positive opinion for Feraccru","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-02-23T01:00:00Z","reference_number":"EMA/84262/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-feraccru_en.pdf"},
    {"id":"29512","name":"Telithromycin film-coated tablets 400 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/315235/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/telithromycin-film-coated-tablets-400-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"29513","name":"EMEA and FDA publish implementation plan for confidentiality arrangement","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-10-04T02:00:00Z","last_updated_date":"2004-10-04T02:00:00Z","reference_number":"EMEA/93356/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-and-fda-publish-implementation-plan-confidentiality-arrangement_en.pdf"},
    {"id":"29515","name":"Maci Article-20 procedure - Closure of EU manufacturing site for Maci","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"EMA/562790/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/maci-article-20-procedure-closure-eu-manufacturing-site-maci_sv.pdf"}},
    {"id":"29516","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"EMA/234702/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting_en.pdf-1"},
    {"id":"29517","name":"Start of community reviews - CHMP meeting of 18-31 May 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/353695/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-18-31-may-2018_en.pdf"},
    {"id":"29518","name":"Presentation - GMP, quality by design and validation (Mats Welin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-27T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gmp-quality-design-and-validation-mats-welin_en.pdf"},
    {"id":"29519","name":"Recognition criteria for self assessment - Enpr-EMA: United Kingdom Paediatric Vaccines\n\nGroup","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2011-01-07T00:31:00Z","reference_number":"EMA/817614/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-united-kingdom-paediatric-vaccines-group_en.pdf"},
    {"id":"29522","name":"Draft assessment report on Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria x ananassa (Weston) Duchesne ex Rozier, folium - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2018-04-11T12:30:00Z","last_updated_date":"2018-04-11T12:30:00Z","reference_number":"EMA/HMPC/432276/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-fragaria-vesca-l-fragaria-moschata-weston-fragaria-viridis-weston-and-fragaria-x-ananassa-weston-duchesne-ex-rozier-folium-first-version_en.pdf"},
    {"id":"29523","name":"EU/3/09/668: Public summary of positive opinion for orphan designation of human C1 inhibitor for the treatment of angioedema caused by C1 inhibitor deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMEA/COMP/470276/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309668-public-summary-positive-opinion-orphan-designation-human-c1-inhibitor-treatment-angioedema-caused-c1-inhibitor-deficiency_en.pdf"},
    {"id":"29525","name":"Overview of comments received on draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-11-03T01:00:00Z","last_updated_date":"2010-11-03T01:00:00Z","reference_number":"EMA/CVMP/561927/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-draft-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-1_en.pdf"},
    {"id":"29527","name":"Presentation - Strengthening collaborations for operating pharmacovigilance in Europe (Dolores Montero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-collaborations-operating-pharmacovigilance-europe-dolores-montero_en.pdf"},
    {"id":"29529","name":"2009 EMEA/IFAH-Europe Info Day London, 12-13 March 2009 - Registration form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:09:21Z","last_updated_date":"2009-02-02T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/2009-emeaifah-europe-info-day-london-12-13-march-2009-registration-form_en.pdf"},
    {"id":"29530","name":"Cooperation between regulators and HTA bodies creates synergies","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-14T13:00:00Z","last_updated_date":"2016-04-14T13:00:00Z","reference_number":"EMA/235891/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/cooperation-between-regulators-and-hta-bodies-creates-synergies_en.pdf"},
    {"id":"29531","name":"Draft procedural advice on the evaluation of advanced therapy medicinal products in accordance with article 8 of Regulation (EC) No 1394/2007","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-03-31T02:00:00Z","last_updated_date":"2009-03-31T02:00:00Z","reference_number":"EMEA/630043/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-procedural-advice-evaluation-advanced-therapy-medicinal-products-accordance-article-8-regulation-ec-no-13942007_en.pdf"},
    {"id":"29532","name":"Presentation - Workshop on endpoints: cystic fibrosis clinical trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-endpoints-cystic-fibrosis-clinical-trials_en.pdf"},
    {"id":"29533","name":"EU/3/14/1423: Public summary of opinion on orphan designation: Synthetic signal peptide of human mucin-1 (amino acids 1-21) for the treatment of plasma cell myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T12:00:00Z","last_updated_date":"2015-03-26T12:00:00Z","reference_number":"EMA/COMP/787373/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141423-public-summary-opinion-orphan-designation-synthetic-signal-peptide-human-mucin-1-amino-acids-1-21-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"29534","name":"Presentation - Case study 3 - Prior knowledge to streamline viral safety and resin lifetime studies - Session 3 (Marie Murphy, Paul Talierco, Nancy Cauwenberghs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-3-prior-knowledge-streamline-viral-safety-and-resin-lifetime-studies-session-3-marie-murphy-paul-talierco-nancy-cauwenberghs_en.pdf"},
    {"id":"29535","name":"Twenty-first pandemic pharmacovigilance update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/472001/2010 ","document_url":"https://www.ema.europa.eu/en/documents/report/twenty-first-pandemic-pharmacovigilance-update_en.pdf"},
    {"id":"29538","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 20-23 October 2014","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2014-10-29T12:20:00Z","last_updated_date":"2014-10-29T12:20:00Z","reference_number":"EMA/129699/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-20-23-october-2014_en.pdf"},
    {"id":"29540","name":"Questions and answers on the referral for Topamax and associated names topiramate tablets and capsules - Final","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-12-15T00:08:21Z","last_updated_date":"2009-12-15T00:08:21Z","reference_number":"EMEA/CHMP/660222/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules-final_sv.pdf"}},
    {"id":"29542","name":"CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 5 March 2013 version 6.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-advice-european-medicines-agency-rules-engagement-accessing-clinical-trial-data-draft-5-march-2013-version-60_en.pdf"},
    {"id":"29545","name":"CPMP elects new chair and vice-chair at its 100th meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-01-20T00:09:21Z","last_updated_date":"2004-01-20T00:09:21Z","reference_number":"EMEA/D/1476/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/cpmp-elects-new-chair-and-vice-chair-its-100th-meeting_en.pdf"},
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    {"id":"29551","name":"Recommendation for the inclusion in Annex II of Council Regulation (EEC) 2377/90 of: Substances with an E number - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/CVMP/020-REV2/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/recommendation-inclusion-annex-ii-council-regulation-eec-237790-substances-e-number-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"29561","name":"Hydrochlorothiazide, ramipril: List of nationally authorised medicinal products - PSUSA/00001660/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-17T02:00:00Z","last_updated_date":"2016-10-17T17:35:00Z","reference_number":"EMA/619987/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-ramipril-list-nationally-authorised-medicinal-products-psusa00001660201501_en.pdf"},
    {"id":"29562","name":"Day 80 assessment report - Non-clinical guidance","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-09-01T02:09:21Z","last_updated_date":"2011-10-13T13:00:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-non-clinical-guidance_en.pdf"},
    {"id":"29563","name":"Presentation - EudraVigilance reporting process for users: Create and send individual case safety reports (ICSRs) using EVWEB - Training Module EV-M3d - Part I","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-06T15:00:00Z","last_updated_date":"2017-01-06T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-reporting-process-users-create-and-send-individual-case-safety-reports-icsrs-using-evweb-training-module-ev-m3d-part-i_en.pdf"},
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    {"id":"29568","name":"Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Insulin Human Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix Marvel","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-01-16T00:09:21Z","last_updated_date":"2008-01-16T00:09:21Z","reference_number":"EMEA/2435/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/marvel-lifesciences-ltd-withdraws-its-marketing-authorisation-applications-insulin-human-rapid-marvel-insulin-human-long-marvel-and-insulin-human-3070-mix-marvel_en.pdf"},
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    {"id":"29572","name":"CHMP post-authorisation summary of positive opinion for Vfend","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/CHMP/306835/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vfend_en.pdf"},
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    {"id":"29576","name":"Report of first European Medicines Agency-EuropaBio annual bilateral meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-09-18T02:00:00Z","last_updated_date":"2017-09-18T02:00:00Z","reference_number":"EMA/382410/2017","document_url":"https://www.ema.europa.eu/en/documents/report/report-first-european-medicines-agency-europabio-annual-bilateral-meeting_en.pdf"},
    {"id":"29580","name":"EU/3/07/434: Public summary of positive opinion for orphan designation of idebenone for the treatment of Leber's hereditary optic neuropathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMEA/COMP/96073/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307434-public-summary-positive-opinion-orphan-designation-idebenone-treatment-lebers-hereditary-optic-neuropathy_en.pdf"},
    {"id":"29581","name":"Almitrine Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-referral-notification_en.pdf"},
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    {"id":"29587","name":"Draft assessment report on Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2012-06-25T12:12:00Z","last_updated_date":"2012-06-25T12:12:00Z","reference_number":"EMA/HMPC/897384/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-paullinia-cupana-kunth-ex-hbk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
    {"id":"29591","name":"Overview of comments received on 'Guideline on the clinical development of medicinal products for the treatment of HIV infection'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-07-12T18:10:00Z","last_updated_date":"2016-07-12T18:10:00Z","reference_number":"EMA/CHMP/EWP/672442/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-development-medicinal-products-treatment-hiv-infection_en.pdf"},
    {"id":"29592","name":"Presentation - Welcome, introduction and goals of the workshop - Joint BWP/QWP workshop with stakeholders in relation to prior knowledge and its use in regulatory applications (V Jekerle/B Dooley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-welcome-introduction-and-goals-workshop-joint-bwpqwp-workshop-stakeholders-relation-prior-knowledge-and-its-use-regulatory-applications-v-jekerleb-dooley_en.pdf"},
    {"id":"29594","name":"Continuous dialogue from product development throughout product lifecycle Tomas Salmonson - Vice Chair CHMP","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/continuous-dialogue-product-development-throughout-product-lifecycle-tomas-salmonson-vice-chair-chmp_en.pdf"},
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    {"id":"29601","name":"Inventory of paediatric therapeutic needs - Ophthalmology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-12T12:00:00Z","last_updated_date":"2014-09-12T12:00:00Z","reference_number":"EMA/PDCO/500455/2014","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-therapeutic-needs-ophthalmology_en.pdf"},
    {"id":"29604","name":"CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Draft advice version 5.0 – Clean version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-advice-european-medicines-agency-clinical-trial-advisory-group-rules-engagement-draft-advice-version-50-clean-version_en.pdf"},
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    {"id":"29609","name":"Presentation - Agenda item 4: substances and products subgroup","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-15T15:00:00Z","last_updated_date":"2016-03-15T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-item-4-substances-and-products-subgroup_en.pdf"},
    {"id":"29613","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Molidustat for the treatment of anaemia due to chronic disorders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-11T12:15:00Z","last_updated_date":"2014-12-11T12:15:00Z","reference_number":"EMA/418357/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-molidustat-treatment-anaemia-due-chronic-disorders_en.pdf"},
    {"id":"29615","name":"Castor oil: summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T17:00:00Z","last_updated_date":"2016-04-28T17:00:00Z","reference_number":"EMA/108531/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/castor-oil-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/castor-oil-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/castor-oil-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/castor-oil-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/castor-oil-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/castor-oil-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/castor-oil-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/castor-oil-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/castor-oil-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/castor-oil-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/castor-oil-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/castor-oil-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/castor-oil-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/castor-oil-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/castor-oil-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/castor-oil-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/castor-oil-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/castor-oil-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/castor-oil-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/castor-oil-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/castor-oil-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/castor-oil-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/castor-oil-summary-public_sv.pdf"}},
    {"id":"29618","name":"EU/3/08/551: Public summary of positive opinion for orphan designation of pegylated recombinant factor VIIa for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMEA/COMP/204668/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308551-public-summary-positive-opinion-orphan-designation-pegylated-recombinant-factor-viia-treatment-haemophilia_en.pdf"},
    {"id":"29621","name":"Guideline adventitious agent safety of urine-derived medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-05-29T12:00:00Z","last_updated_date":"2015-05-29T12:00:00Z","reference_number":"EMA/CHMP/BWP/126802/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-adventitious-agent-safety-urine-derived-medicinal-products_en.pdf"},
    {"id":"29622","name":"Swiss PedNet - European Network of Paediatric Research at the European Medicines Agency recognition criteria for self-assessment","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-21T16:40:00Z","last_updated_date":"2013-03-21T16:40:00Z","reference_number":"EMA/25452/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/swiss-pednet-european-network-paediatric-research-european-medicines-agency-recognition-criteria-self-assessment_en.pdf"},
    {"id":"29625","name":"Note for guidance on electronic exchange of pharmacovigilance information for human and veterinary medicinal products in the European Union","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-08-18T02:00:00Z","last_updated_date":"1999-08-18T02:00:00Z","reference_number":"EMEA/CXMP/PhWHP/2056/","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-electronic-exchange-pharmacovigilance-information-human-and-veterinary-medicinal-products-european-union_en.pdf"},
    {"id":"29628","name":"Sirolimus coated tablets 0.5, 1 and 2 mg, oral solution 1 mg/ml product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/315231/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/sirolimus-coated-tablets-05-1-and-2-mg-oral-solution-1-mgml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"29629","name":"EU/3/17/1882: Public summary of opinion on orphan designation: Ibutamoren mesilate for the treatment of growth hormone deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/325369/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171882-public-summary-opinion-orphan-designation-ibutamoren-mesilate-treatment-growth-hormone-deficiency_en.pdf"},
    {"id":"29630","name":"Overview of comments received on the guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-19T13:15:00Z","last_updated_date":"2013-07-19T13:15:00Z","reference_number":"EMA/CHMP/107622/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-urinary-incontinence_en.pdf"},
    {"id":"29633","name":"Arimidex - Article 30 referral - Assessment Report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/418072/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/arimidex-article-30-referral-assessment-report_en.pdf"},
    {"id":"29634","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T13:30:00Z","last_updated_date":"2015-08-11T13:30:00Z","reference_number":"EMA/454226/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-july-2015_en.pdf"},
    {"id":"29639","name":"Human medicines highlights - October 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-11-10T12:20:00Z","last_updated_date":"2015-11-10T12:20:00Z","reference_number":"Issue 80","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-october-2015_en.pdf"},
    {"id":"29644","name":"Gingko biloba: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/668/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gingko-biloba-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"29645","name":"CHMP post-authorisation summary of positive opinion for Caprelsa","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T01:00:00Z","last_updated_date":"2016-11-11T01:00:00Z","reference_number":"EMA/CHMP/200154/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-caprelsa_en.pdf"},
    {"id":"29647","name":"Management Board initiates building approval process for EMA premises in Amsterdam","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-28T18:00:00Z","last_updated_date":"2018-02-28T18:00:00Z","reference_number":"EMA/114836/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/management-board-initiates-building-approval-process-ema-premises-amsterdam_en.pdf"},
    {"id":"29649","name":"EU/3/01/078: Public summary of opinion on orphan designation: iduronate-2-sulfatase for the treatment of mucopolysaccharidosis, type II (Hunter Syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2017-02-08T01:00:00Z","reference_number":"EMA/COMP/1281/2003 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301078-public-summary-opinion-orphan-designation-iduronate-2-sulfatase-treatment-mucopolysaccharidosis-type-ii-hunter-syndrome_en.pdf"},
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    {"id":"29652","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) concentration types","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:01Z","last_updated_date":"2014-01-17T18:15:00Z","reference_number":"EMA/136154/2012 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-concentration-types_en.xls"},
    {"id":"29653","name":"Questions and answers on Article 34 veterinary referral procedures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T18:00:00Z","last_updated_date":"2017-12-20T18:00:00Z","reference_number":"EMA/503276/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-article-34-veterinary-referral-procedures_en.pdf"},
    {"id":"29655","name":"Note for guidance on the development of vaccinia virus based vaccines against smallpox","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-06-24T02:00:00Z","last_updated_date":"2002-06-24T02:00:00Z","reference_number":"CPMP/1100/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-development-vaccinia-virus-based-vaccines-against-smallpox_en.pdf"},
    {"id":"29657","name":"Propyl 4-hydroxybenzoate and its sodium salt (all food producing species): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-09-08T16:35:00Z","last_updated_date":"2015-09-08T16:35:00Z","reference_number":"EMA/CVMP/632934/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/propyl-4-hydroxybenzoate-and-its-sodium-salt-all-food-producing-species-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"29659","name":"Agenda - CAT agenda of the 19–20 February 2015 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T13:00:00Z","last_updated_date":"2015-03-02T13:00:00Z","reference_number":"EMA/CAT/81435/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-19-20-february-2015-meeting_en.pdf"},
    {"id":"29660","name":"Presentation - Welcome and opening remarks (Christian Siebert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T02:00:00Z","last_updated_date":"2018-04-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-welcome-and-opening-remarks-christian-siebert_en.pdf"},
    {"id":"29661","name":"Update on EMEA implementation of EU Telematics strategy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-03-05T00:09:21Z","last_updated_date":"2009-03-05T00:09:21Z","reference_number":"EMEA/MB/20870/2009","document_url":"https://www.ema.europa.eu/en/documents/report/update-emea-implementation-eu-telematics-strategy_en.pdf"},
    {"id":"29665","name":"Presentation - Learnings & next steps for EMSP as initiator and driver (C.Thalheim, J.Hlavacova)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-learnings-next-steps-emsp-initiator-and-driver-cthalheim-jhlavacova_en.pdf"},
    {"id":"29666","name":"Agenda - PRAC draft agenda of meeting 13-16 May 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-05-14T18:15:00Z","last_updated_date":"2013-05-14T18:15:00Z","reference_number":"EMA/PRAC/291178/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-13-16-may-2013_en.pdf"},
    {"id":"29667","name":"Superseded - Opinion of the HMPC on a Community herbal monograph on Aloe barbadensis Miller and Aloe (various species, mainly Aloe ferox Miller and its hybrids)","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-09-07T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMEA/HMPC/429376/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-aloe-barbadensis-miller-and-aloe-various-species-mainly-aloe-ferox-miller-and-its-hybrids_en.pdf"},
    {"id":"29669","name":"VICH GL36(R): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-07-25T12:40:00Z","last_updated_date":"2012-07-25T12:40:00Z","reference_number":"EMA/CVMP/VICH/467/2003","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl36r-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-microbiological-adi-first-version_en.pdf"},
    {"id":"29670","name":"Presentation - Web-RADR: use of mobile applications for ADRs reporting and social media data mining (Franà§ois Houà¿ez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-web-radr-use-mobile-applications-adrs-reporting-and-social-media-data-mining-franassois-houaez_en.pdf"},
    {"id":"29671","name":"Chloroprocaine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010078/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-30T18:11:00Z","last_updated_date":"2017-11-30T18:12:49Z","reference_number":"EMA/796919/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/chloroprocaine-hydrochloride-list-nationally-authorised-medicinal-products-psusa00010078201703_en.pdf"},
    {"id":"29672","name":"Minutes of the European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting on 5 June 2013","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-07-12T17:00:00Z","last_updated_date":"2013-07-12T17:00:00Z","reference_number":"EMA/361720/2013","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting-5-june-2013_en.pdf"},
    {"id":"29673","name":"Appointment of an Acting Executive Director, Management Board meeting 7 October 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-11-04T01:00:00Z","last_updated_date":"2010-11-04T01:00:00Z","reference_number":"EMA/MB/578243/2010","document_url":"https://www.ema.europa.eu/en/documents/other/appointment-acting-executive-director-management-board-meeting-7-october-2010_en.pdf"},
    {"id":"29674","name":"Hydroxybenzoic acid esters and their sodium salts: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-02-01T01:00:00Z","last_updated_date":"1996-02-01T01:00:00Z","reference_number":"EMEA/MRL/051/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hydroxybenzoic-acid-esters-and-their-sodium-salts-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"29675","name":"Work instructions for preparation of the annual good-manufacturing-practice re-inspection programme","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2012-09-28T12:00:00Z","last_updated_date":"2012-09-28T12:00:00Z","reference_number":"WIN/INSP/2046","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-preparation-annual-good-manufacturing-practice-re-inspection-programme_en.pdf"},
    {"id":"29676","name":"CHMP summary of positive opinion for Rekovelle","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"EMA/CHMP/635107/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rekovelle_en.pdf"},
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    {"id":"29680","name":"EU/3/05/347: Public summary of positive opinion for orphan designation of human monoclonal antibody against HLA-DR for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/414041/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305347-public-summary-positive-opinion-orphan-designation-human-monoclonal-antibody-against-hla-dr-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
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    {"id":"29686","name":"Draft community herbal monograph on Avena sativa L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-10-31T00:09:21Z","last_updated_date":"2007-10-31T00:09:21Z","reference_number":"EMEA/HMPC/202966/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-avena-sativa-l-herba_en.pdf"},
    {"id":"29688","name":"Presentation - CVMP ad hoc veterinary expert group on novel therapies ADVENT (Fia Westerholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-27T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-ad-hoc-veterinary-expert-group-novel-therapies-advent-fia-westerholm_en.pdf"},
    {"id":"29689","name":"Presentation - Promoting innovation through the veterinary regulatory framework: Role of EMA - European Medicines Agency veterinary medicines innovation day (David Mackay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-promoting-innovation-through-veterinary-regulatory-framework-role-ema-european-medicines-agency-veterinary-medicines-innovation-day-david-mackay_en.pdf"},
    {"id":"29691","name":"European Medicines Agency recommends suspension of Octagam in all EU Member States","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2010-09-24T02:00:00Z","reference_number":"EMA/CHMP/591722/2010 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-octagam-all-eu-member-states_en.pdf"},
    {"id":"29693","name":"Scientific advice and protocol assistance adopted during the CHMP meeting of 18-21 March 2013","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T01:00:00Z","last_updated_date":"2013-03-22T01:00:00Z","reference_number":"EMA/174552/2013","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-18-21-march-2013_en.pdf"},
    {"id":"29697","name":"Committee for medicinal products for veterinary use summary of opinion: BTVPUR Alsap 8: International Non-proprietary Names (INN): inactivated bluetongue virus Serotype 8","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-02-13T01:09:21Z","last_updated_date":"2018-05-16T02:09:21Z","reference_number":"EMEA/CVMP/685571/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-btvpur-alsap-8-international-non-proprietary-names-inn-inactivated-bluetongue-virus-serotype-8_en.pdf"},
    {"id":"29698","name":"Superseded list of references supporting the assessment report on: Sambuci flos Sambucus nigra L., flos (elder flower) - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2018-06-27T02:09:21Z","reference_number":"EMEA/HMPC/283842/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-sambuci-flos-sambucus-nigra-l-flos-elder-flower-first-version_en.pdf"},
    {"id":"29699","name":"EU/3/10/844: Public summary of opinion on orphan designation: Axitinib for the treatment of renal-cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2012-12-03T01:00:00Z","reference_number":"EMA/COMP/2608/2011, Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310844-public-summary-opinion-orphan-designation-axitinib-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"29700","name":"Review concludes evidence does not support that HPV vaccines cause CRPS or POTS","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-11-05T01:00:00Z","last_updated_date":"2015-11-05T01:00:00Z","reference_number":"EMA/714950/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-concludes-evidence-does-not-support-hpv-vaccines-cause-crps-or-pots_en.pdf"},
    {"id":"29704","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the seventy eighth meeting of the committee for veterinary medicinal products took place in London on 11 - 13 June 2002.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-06-14T14:09:21Z","last_updated_date":"2002-06-14T14:09:21Z","reference_number":"EMEA/CVMP/621/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-seventy-eighth-meeting-committee-veterinary-medicinal-products-took-place-london-11-13-june-2002_en.pdf"},
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    {"id":"29719","name":"Superseded list of references supporting the assessment of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2018-08-20T02:00:00Z","reference_number":"EMA/HMPC/560963/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-pelargonium-sidoides-dc-andor-pelargonium-reniforme-curt-radix-first-version_en.pdf"},
    {"id":"29721","name":"Meeting Requirements for EU Marketing Authorization: Genotoxicity and Carcinogenicity - Dr Peter Kasper","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-02T00:00:00Z","last_updated_date":"2009-02-02T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/meeting-requirements-eu-marketing-authorization-genotoxicity-and-carcinogenicity-dr-peter-kasper_en.pdf"},
    {"id":"29722","name":"Cidofovir: List of nationally authorised medicinal products - PSUSA/00010558/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-17T16:30:00Z","last_updated_date":"2018-01-17T16:32:38Z","reference_number":"EMA/32409/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cidofovir-list-nationally-authorised-medicinal-products-psusa00010558201706_en.pdf"},
    {"id":"29723","name":"Presentation - Update on implementation of pharmacovigilance legislation (Franck Diafouka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-implementation-pharmacovigilance-legislation-franck-diafouka_en.pdf"},
    {"id":"29725","name":"Levothyroxine Alapis - Article 29(4) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2013-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/levothyroxine-alapis-article-294-referral-annex-i_sv.pdf"}},
    {"id":"29727","name":"Public statement on Advasure (classical swine fever virus E2 subunit antigen) - withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-02-13T00:09:21Z","last_updated_date":"2008-02-13T00:09:21Z","reference_number":"EMEA/CVMP/138988/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-advasure-classical-swine-fever-virus-e2-subunit-antigen-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"29728","name":"Final European Union herbal monograph on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-07-07T02:00:00Z","reference_number":"EMA/HMPC/80630/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-cortex_en.pdf"},
    {"id":"29729","name":"CHMP post-authorisation summary of positive opinion for Dafiro HCT","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/CHMP/397292/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dafiro-hct_en.pdf"},
    {"id":"29731","name":"COMP meeting report on the review of applications for orphan designation: October 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-10-11T11:55:00Z","last_updated_date":"2012-10-11T11:55:00Z","reference_number":"EMA/COMP/621766/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-october-2012_en.pdf"},
    {"id":"29733","name":"ICH: S 3 A: Toxicokinetics: A guidance for assessing systemic exposure in toxicology studies - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1994-11-30T01:00:00Z","last_updated_date":"1994-11-30T01:00:00Z","reference_number":"CPMP/ICH/384/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-3-toxicokinetics-guidance-assessing-systemic-exposure-toxicology-studies-step-5_en.pdf"},
    {"id":"29734","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Direct-acting antivirals for hepatitis C: EMA confirms recommendation to screen for hepatitis 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    {"id":"29738","name":"CHMP post-authorisation summary of positive opinion for Binocrit on 23 October 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:09:21Z","last_updated_date":"2008-10-23T02:09:21Z","reference_number":"EMEA/CHMP/567061/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-binocrit-23-october-2008_en.pdf"},
    {"id":"29740","name":"Raspberry leaf: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-07-06T02:00:00Z","last_updated_date":"2017-07-06T02:00:00Z","reference_number":"EMA/237849/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/raspberry-leaf-summary-public_en.pdf"},
    {"id":"29741","name":"CHMP summary of positive opinion for Zoledronic Acid Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T13:00:00Z","last_updated_date":"2013-11-22T13:00:00Z","reference_number":"EMA/CHMP/523516/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zoledronic-acid-accord_en.pdf"},
    {"id":"29742","name":"Human medicines highlights 2015","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T11:00:00Z","last_updated_date":"2016-01-11T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/human-medicines-highlights-2015_en.pdf"},
    {"id":"29743","name":"European Medicines Agency budget for 2009","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-05T10:40:00Z","last_updated_date":"2013-03-05T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2009_en.pdf"},
    {"id":"29744","name":"Sodium salicylate - European Public MRL Assessment Report (EPMAR) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2010-11-12T01:00:00Z","last_updated_date":"2010-11-12T01:00:00Z","reference_number":"EMA/CVMP/529651/2009","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sodium-salicylate-european-public-mrl-assessment-report-epmar-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"29745","name":"Overview of comments received on procedure on management of proposals submitted by interested parties for community list entries or community herbal monographs (EMEA/HMPC/328575/2007) - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-05-08T02:00:00Z","last_updated_date":"2008-05-08T02:00:00Z","reference_number":"EMEA/HMPC/191615/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-procedure-management-proposals-submitted-interested-parties-community-list-entries-or-community-herbal-monographs-emeahmpc3285752007-revision-1_en.pdf"},
    {"id":"29747","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 9-10 March 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-04-01T17:05:00Z","last_updated_date":"2015-04-01T17:05:00Z","reference_number":"EMA/HMPC/180661/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-9-10-march-2015_en.pdf"},
    {"id":"29748","name":"Question and answer on the CVMP guideline on the summary of product characteristics for antimicrobial products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-20T02:00:00Z","last_updated_date":"2016-02-26T15:10:00Z","reference_number":"EMA/CVMP/414812/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/other/question-and-answer-cvmp-guideline-summary-product-characteristics-antimicrobial-products_en.pdf"},
    {"id":"29749","name":"The work of the European Medicines Agency - Vital for EU public and animal health and the pharmaceutical industry","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2016-10-11T14:45:00Z","last_updated_date":"2016-10-11T14:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/work-european-medicines-agency-vital-eu-public-and-animal-health-and-pharmaceutical-industry_en.pdf"},
    {"id":"29751","name":"Presentation - ISPE paper 'Evaluating the effectiveness of additional risk minimisation measures via surveys in Europe: Challenges and recommendations (Rachel Sobel, Terry Madison)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ispe-paper-evaluating-effectiveness-additional-risk-minimisation-measures-surveys-europe-challenges-and-recommendations-rachel-sobel-terry-madison_en.pdf"},
    {"id":"29754","name":"Public bulletin: Veterinary pharmacovigilance 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T15:30:00Z","last_updated_date":"2016-02-26T15:30:00Z","reference_number":"EMA/CVMP/448211/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-bulletin-veterinary-pharmacovigilance-2015_en.pdf"},
    {"id":"29755","name":"Brief summary of the existing systems on collecting data: Germany","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-germany_en.pdf"},
    {"id":"29756","name":"Towards biosimilar monoclonal antibodies - Pros and cons - Christian K Schneider","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/towards-biosimilar-monoclonal-antibodies-pros-and-cons-christian-k-schneider_en.pdf"},
    {"id":"29760","name":"Product eligibility for adaptive pathways","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-09T01:00:00Z","last_updated_date":"2016-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/product-eligibility-adaptive-pathways_en.pdf"},
    {"id":"29761","name":"Role and responsibilities of members and alternates, rapporteur and peer reviewers, experts and observers of the paediatric committee","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-27T01:00:00Z","last_updated_date":"2010-09-17T02:00:00Z","reference_number":"EMEA/537415/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/role-and-responsibilities-members-and-alternates-rapporteur-and-peer-reviewers-experts-and-observers-paediatric-committee_en.pdf"},
    {"id":"29764","name":"Questions and answers on withdrawal of the application for a change to the marketing authorisation for Qutenza (capsaicin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-04-16T02:00:00Z","last_updated_date":"2012-04-16T02:00:00Z","reference_number":"EMA/212297/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-qutenza-capsaicin_sv.pdf"}},
    {"id":"29765","name":"EU/3/02/098: Public summary of positive opinion for orphan designation of epothilone B for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-06-11T02:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMEA/COMP/81/02 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302098-public-summary-positive-opinion-orphan-designation-epothilone-b-treatment-ovarian-cancer_en.pdf"},
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    {"id":"29823","name":"European Medicines Agency workshop on first-in-man clinical trials draft guideline","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-18T02:09:21Z","last_updated_date":"2007-06-18T02:09:21Z","reference_number":"EMEA/262385/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-workshop-first-man-clinical-trials-draft-guideline_en.pdf"},
    {"id":"29825","name":"Renin-angiotensin-system (RAS)-acting agents Article-31 referral - Scientific conclusion - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-08T02:00:00Z","last_updated_date":"2014-10-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/renin-angiotensin-system-ras-acting-agents-article-31-referral-scientific-conclusion-annex-i_sv.pdf"}},
    {"id":"29827","name":"EU/3/15/1461: Public summary of positive opinion for orphan designation of recombinant human monoclonal antibody binding to vascular adhesion protein-1 for the treatment of primary sclerosing cholangitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/132952/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151461-public-summary-positive-opinion-orphan-designation-recombinant-human-monoclonal-antibody-binding-vascular-adhesion-protein-1-treatment-primary-sclerosing-cholangitis_en.pdf"},
    {"id":"29828","name":"Final assessment report on Syzygium aromaticum (L.) Merill et L.M. Perry, flos and Syzygium aromaticum (L.) Merill et L.M. Perry, floris aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T01:00:00Z","last_updated_date":"2011-12-21T01:00:00Z","reference_number":"EMA/HMPC/534946/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-syzygium-aromaticum-l-merill-et-lm-perry-flos-and-syzygium-aromaticum-l-merill-et-lm-perry-floris-aetheroleum_en.pdf"},
    {"id":"29829","name":"Doxagamma 4 mg - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-10-11T02:08:21Z","last_updated_date":"2006-10-11T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/doxagamma-4-mg-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"29830","name":"Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-02T13:20:00Z","last_updated_date":"2017-08-02T13:20:00Z","reference_number":"EMA/INS/GMP/443117/2017","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-production-water-injections-non-distillation-methods-reverse-osmosis-and-biofilms-and-control-strategies-final_en.pdf-0"},
    {"id":"29833","name":"Recommendation for maintenance of orphan designation at the time of addition of a new indication to the marketing authorisation: Revlimid (lenalidomide) for the treatment of mantle cell lymphoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-07-20T02:00:00Z","last_updated_date":"2016-07-20T02:00:00Z","reference_number":"EMA/COMP/450189/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-addition-new-indication-marketing-authorisation-revlimid-lenalidomide-treatment-mantle-cell-lymphoma_en.pdf"},
    {"id":"29835","name":"Presentation -  Chemistry, manufacturing, and control (CMC) development and manufacturing challenges (Steven Howe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chemistry-manufacturing-and-control-cmc-development-and-manufacturing-challenges-steven-howe_en.pdf"},
    {"id":"29839","name":"CHMP post-authorisation summary of positive opinion for Keytruda","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/CHMP/849400/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda_en.pdf-0"},
    {"id":"29840","name":"Letter of invitation to tender - EMA/2012/18/HR Procurement procedure for medical services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/453462/2012","document_url":"https://www.ema.europa.eu/en/documents/other/letter-invitation-tender-ema201218hr-procurement-procedure-medical-services_en.pdf"},
    {"id":"29842","name":"EU/3/05/348: Public summary of positive opinion for orphan designation of purified inactivated Japanese encephalitis SA14-4-2 virus vaccine for the prevention of Japanese encephalitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/COMP/24246/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305348-public-summary-positive-opinion-orphan-designation-purified-inactivated-japanese-encephalitis-sa14-4-2-virus-vaccine-prevention-japanese-encephalitis_en.pdf"},
    {"id":"29843","name":"Quality Review of Documents recommendations on the expression of strength in the name of centrally authorised human medicinal products","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-11-18T01:00:00Z","last_updated_date":"2009-11-18T01:00:00Z","reference_number":"EMA/707229/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-recommendations-expression-strength-name-centrally-authorised-human-medicinal-products_en.pdf"},
    {"id":"29845","name":"CHMP post-authorisation summary of positive opinion for Nplate","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/CHMP/849254/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-nplate_en.pdf-0"},
    {"id":"29846","name":"EU/3/12/991: Public summary of opinion on orphan designation: Exon-45-specific phosphorothioate oligonucleotide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2012-06-18T13:00:00Z","reference_number":"EMA/COMP/193672/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312991-public-summary-opinion-orphan-designation-exon-45-specific-phosphorothioate-oligonucleotide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"29848","name":"Questions and answers on the review of oral formulations of medicines containing norfloxacin","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/378867/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-oral-formulations-medicines-containing-norfloxacin_en.pdf"},
    {"id":"29849","name":"Presentation - Guideline on similar biological medicinal products\n\ncontaining biotechnology-derived proteins as active substance: non-clinical and clinical issues (Hans-Karl Heim)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-hans-karl-heim_en.pdf"},
    {"id":"29850","name":"EU/3/05/321: Public Summary of opinion on orphan designation: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2013-03-11T12:15:00Z","reference_number":"EMA/COMP/245993/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305321-public-summary-opinion-orphan-designation-1r2r4s-4-2r-2-3s6r7e9r10r12r14s15e17e19e21s23s26r27r34as-927-dihydroxy-1021-dimethoxy-6812142026-hexamethyl_en.pdf"},
    {"id":"29853","name":"Latanoprost (products with paediatric indication) : List of nationally authorised medicinal products - PSUSA/00001834/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T15:57:00Z","last_updated_date":"2017-12-01T16:00:00Z","reference_number":"EMA/797779/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/latanoprost-products-paediatric-indication-list-nationally-authorised-medicinal-products-psusa00001834201704_en.pdf"},
    {"id":"29856","name":"IFAH-Europe meeting with CVMP and SAGAM - Anno de Jong","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ifah-europe-meeting-cvmp-and-sagam-anno-de-jong_en.pdf"},
    {"id":"29857","name":"Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-10T02:00:00Z","last_updated_date":"2016-10-17T17:40:40Z","reference_number":"EMA/540462/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/acitretin-list-nationally-authorised-medicinal-products-psusa00000051201510_en.pdf"},
    {"id":"29858","name":"Merck Sharp and Dohme Ltd. withdraws its marketing-authorisation application for Jenzyl (ridaforolimus)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T11:58:37Z","last_updated_date":"2012-11-30T11:58:37Z","reference_number":"EMA/764967/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/merck-sharp-and-dohme-ltd-withdraws-its-marketing-authorisation-application-jenzyl-ridaforolimus_en.pdf"},
    {"id":"29861","name":"Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/benefits-combined-hormonal-contraceptives-chcs-continue-outweigh-risks_sv.pdf"}},
    {"id":"29863","name":"Opinion of the CVMP on the establishment of maximum residue limits: Octenidine dihydrochloride","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-03-22T01:00:00Z","last_updated_date":"2012-03-22T01:00:00Z","reference_number":"EMA/CVMP/61867/2011-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-octenidine-dihydrochloride_en.pdf"},
    {"id":"29869","name":"Public Hearing - Guidance for participants","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-07-11T14:00:00Z","last_updated_date":"2018-04-09T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/public-hearing-guidance-participants_en.pdf"},
    {"id":"29871","name":"Draft list of references supporting the assessment of Curcuma xanthorrhiza roxb., rhizoma","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-06-19T02:00:00Z","last_updated_date":"2013-06-19T02:00:00Z","reference_number":"EMA/HMPC/604598/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-curcuma-xanthorrhiza-roxb-rhizoma_en.pdf"},
    {"id":"29873","name":"CHMP summary of positive opinion for Daliresp","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2018-02-06T01:00:00Z","reference_number":"EMA/CHMP/825394/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-daliresp_en.pdf"},
    {"id":"29879","name":"Call for submission of scientific data on Allium cepa L., bulbus Allii cepae bulbus (onion)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/HMPC/148780/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-allium-cepa-l-bulbus-allii-cepae-bulbus-onion_en.pdf"},
    {"id":"29880","name":"Presentation - Key aspects of non-clinical pharmacology and pharmacokinetics in the evaluation of safety (David R Jones)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T18:12:00Z","last_updated_date":"2016-10-26T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-aspects-non-clinical-pharmacology-and-pharmacokinetics-evaluation-safety-david-r-jones_en.pdf"},
    {"id":"29881","name":"Registration form: EMA-EFPIA Info day 2011 - 23 May 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-30T01:31:00Z","last_updated_date":"2011-03-30T01:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/registration-form-ema-efpia-info-day-2011-23-may-2011_en.pdf"},
    {"id":"29883","name":"Phytomenadione (Vitamin K1) and menadione (Vitamin K3): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/447/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phytomenadione-vitamin-k1-and-menadione-vitamin-k3-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"29885","name":"EU/3/10/757: Public summary of opinion on orphan designation for pomalidomide for the treatment of primary myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-06T02:00:00Z","last_updated_date":"2017-02-10T12:26:00Z","reference_number":"EMA/COMP/249369/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310757-public-summary-opinion-orphan-designation-pomalidomide-treatment-primary-myelofibrosis_en.pdf"},
    {"id":"29886","name":"EU/3/15/1539: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene for the treatment of X-linked myotubular myopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2015-10-02T02:00:00Z","reference_number":"EMA/COMP/500586/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151539-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-8-containing-human-mtm1-gene-treatment-x-linked-myotubular-myopathy_en.pdf"},
    {"id":"29887","name":"Presentation - Longitudinal model-based test as primary analysis in phase III - Break-out session 4 theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:15:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-longitudinal-model-based-test-primary-analysis-phase-iii-break-out-session-4-theme-2_en.pdf"},
    {"id":"29888","name":"Withdrawal assessment report for Keytruda","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-11-28T01:00:00Z","last_updated_date":"2017-11-28T01:00:00Z","reference_number":"EMA/687095/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-keytruda_en.pdf"},
    {"id":"29889","name":"EU/3/03/132: Public summary of positive opinion for orphan designation of caffeine citrate for the treatment of primary apnoea of premature newborns","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-03-07T00:00:00Z","last_updated_date":"2019-07-11T00:00:00Z","reference_number":"EMEA/COMP/5/03 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303132-public-summary-positive-opinion-orphan-designation-caffeine-citrate-treatment-primary-apnoea-premature-newborns_en.pdf"},
    {"id":"29891","name":"Draft assessment report on Serenoa repens (W. Bartram) Small, fructus","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-12-22T17:40:00Z","last_updated_date":"2014-12-22T17:40:00Z","reference_number":"EMA/HMPC/137250/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"29894","name":"Final list of references supporting the assessment of Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-07-07T02:00:00Z","reference_number":"EMA/HMPC/80629/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-cortex_en.pdf"},
    {"id":"29895","name":"Press release: Committee for Orphan Medicinal Products February 2007 Meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2007-02-07T00:09:21Z","last_updated_date":"2007-02-07T00:09:21Z","reference_number":"EMEA/COMP/44996/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-committee-orphan-medicinal-products-february-2007-meeting_en.pdf"},
    {"id":"29896","name":"PDCO meeting highlights 8-10 September 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-09-22T02:00:00Z","last_updated_date":"2010-09-27T02:00:00Z","reference_number":"EMA/PDCO/534094/2010 Correction 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-8-10-september-2010_en.pdf"},
    {"id":"29898","name":"Withdrawal assessment report for Veraseal","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-12-10T01:00:00Z","last_updated_date":"2015-12-10T01:00:00Z","reference_number":"EMA/674875/2015","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-veraseal_en.pdf"},
    {"id":"29901","name":"Innovation task force dates for submission of requests for briefing meetings & regulatory advice on the eligibility to EMEA procedures as medicinal products 2009","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-06-03T02:00:00Z","last_updated_date":"2009-06-03T02:00:00Z","reference_number":"EMEA/68722/2008","document_url":"https://www.ema.europa.eu/en/documents/other/innovation-task-force-dates-submission-requests-briefing-meetings-regulatory-advice-eligibility-emea-procedures-medicinal-products-2009_en.pdf"},
    {"id":"29902","name":"Public summary of negative opinion for orphan designation of naltrexone for the treatment of fibromyalgia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2016-12-13T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-naltrexone-treatment-fibromyalgia_en.pdf"},
    {"id":"29903","name":"Final community herbal monograph on Leonurus cardiaca L., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/HMPC/127428/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-leonurus-cardiaca-l-herba_en.pdf"},
    {"id":"29904","name":"CHMP summary of positive opinion for Pomalidomide Celgene","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T14:00:00Z","last_updated_date":"2013-05-31T14:00:00Z","reference_number":"EMA/306855/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pomalidomide-celgene_en.pdf"},
    {"id":"29905","name":"Shortage of Apidra (insulin glulisine) cartridges","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-09-22T18:08:00Z","last_updated_date":"2011-09-22T18:08:00Z","reference_number":"EMA/CHMP/769286/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/shortage-apidra-insulin-glulisine-cartridges_en.pdf"},
    {"id":"29906","name":"Presentation - Progress update: MLM and EV auditable requirements project (Georgy Genov)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T17:30:00Z","last_updated_date":"2017-03-30T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-progress-update-mlm-and-ev-auditable-requirements-project-georgy-genov_en.pdf"},
    {"id":"29910","name":"Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1)","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2013-01-24T18:00:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/36988/2013","document_url":"https://www.ema.europa.eu/en/documents/template-form/guideline-good-pharmacovigilance-practices-annex-ii-templates-direct-healthcare-professional-communication-dhpc-rev-1_en.pdf"},
    {"id":"29911","name":"EMA Management Board: highlights of October 2017 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-06T02:00:00Z","last_updated_date":"2017-10-06T02:00:00Z","reference_number":"EMA/659964/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-october-2017-meeting_en.pdf"},
    {"id":"29913","name":"Arnica flower: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T01:00:00Z","last_updated_date":"2016-12-02T01:00:00Z","reference_number":"EMA/654173/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/arnica-flower-summary-public_en.pdf"},
    {"id":"29914","name":"CHMP summary of positive opinion for Cosentyx","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2014-11-21T13:00:00Z","reference_number":"EMA/CHMP/489954/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cosentyx_en.pdf"},
    {"id":"29917","name":"Presentation - In vivo evaluation of lumpy skin disease vaccine efficacy in controlled environment (Kris De Clercq)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T11:37:00Z","last_updated_date":"2017-05-18T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-vivo-evaluation-lumpy-skin-disease-vaccine-efficacy-controlled-environment-kris-de-clercq_en.pdf"},
    {"id":"29918","name":"Guideline on the scientific data requirements for a plasma master file (PMF) - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-11-15T01:00:00Z","last_updated_date":"2006-11-15T01:00:00Z","reference_number":"EMEA/CHMP/BWP/3794/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-data-requirements-plasma-master-file-pmf-revision-1_en.pdf"},
    {"id":"29919","name":"EU network strategy to 2020 (Noel Wathion and Monica Dias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-01T02:00:00Z","last_updated_date":"2015-09-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-network-strategy-2020-noel-wathion-and-monica-dias_en.pdf"},
    {"id":"29920","name":"Numeta Article-107i procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-review-started_en.pdf"},
    {"id":"29921","name":"Agenda - Workshop for micro, small and medium-sized enterprises (SMEs) organised by the SME office \"Focus on Scientific and Regulatory Advice\"","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-03-24T01:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"EMA/204912/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-micro-small-and-medium-sized-enterprises-smes-organised-sme-office-focus-scientific-and-regulatory-advice_en.pdf"},
    {"id":"29922","name":"Committee for medicinal products for human use post-authorisation summary of positive opinion for Corlentor/Procorolan on 24 September 2009","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/CHMP/608839/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-post-authorisation-summary-positive-opinion-corlentorprocorolan-24-september-2009_en.pdf"},
    {"id":"29924","name":"Lecirelin (LE): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-18T01:00:00Z","last_updated_date":"1997-02-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lecirelin-le-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"29930","name":"EMEA recommends new contraindication for Velcade (bortezomib)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T01:00:00Z","last_updated_date":"2008-03-20T01:00:00Z","reference_number":"EMEA/139443/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-new-contraindication-velcade-bortezomib_en.pdf"},
    {"id":"29931","name":"SGLT2 inhibitors Article-20 procedure - PRAC makes recommendations to minimise risk of diabetic ketoacidosis","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-12T01:00:00Z","last_updated_date":"2016-02-12T01:00:00Z","reference_number":"EMA/100751/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-article-20-procedure-prac-makes-recommendations-minimise-risk-diabetic-ketoacidosis_en.pdf"},
    {"id":"29932","name":"Presentation - SME’s perspective on scientific and regulatory advice, Dr. Lene Rose Arfelt","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-smes-perspective-scientific-and-regulatory-advice-dr-lene-rose-arfelt_en.pdf"},
    {"id":"29935","name":"CVMP summary of positive opinion for Suvaxyn PRRS MLV","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-06-16T02:00:00Z","last_updated_date":"2017-06-16T02:00:00Z","reference_number":"EMA/CVMP/327193/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-suvaxyn-prrs-mlv_en.pdf"},
    {"id":"29936","name":"Draft community herbal monograph on Rosmarinus officinalis L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/13633/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-rosmarinus-officinalis-l-folium_en.pdf"},
    {"id":"29937","name":"EU/3/12/958: Public summary of opinion on orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine and folic acid","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T01:00:00Z","last_updated_date":"2012-11-12T01:00:00Z","reference_number":"EMA/COMP/853895/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312958-public-summary-opinion-orphan-designation-n-4-2-amino-34-dihydro-4-oxo-6-pteridinylmethylaminobenzoyl-d-gamma-glutamyl-2s-2-amino-beta-alanyl-l-alpha-aspartyl-l-cysteine-and-folic-acid_en.pdf"},
    {"id":"29938","name":"Report on budgetary and financial management: Financial year 2012","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-07-04T11:40:00Z","last_updated_date":"2013-07-04T11:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2012_en.pdf"},
    {"id":"29939","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-05-13T14:11:00Z","last_updated_date":"2016-05-13T14:11:00Z","reference_number":"EMA/246326/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-april-2016_en.pdf"},
    {"id":"29942","name":"EU/3/06/415: Public summary of positive opinion for orphan designation of ciclosporin (implant) for the prevention of rejection of corneal transplant","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2010-03-15T01:00:00Z","reference_number":"EMEA/COMP/191077/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306415-public-summary-positive-opinion-orphan-designation-ciclosporin-implant-prevention-rejection-corneal-transplant_en.pdf"},
    {"id":"29943","name":"Presentation - 1.1 ENCePP: Where are we  and where are we going?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-23T01:00:00Z","last_updated_date":"2011-11-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11-encepp-where-are-we-and-where-are-we-going_en.pdf"},
    {"id":"29944","name":"Overview of the EudraVigilance training on electronic reporting of ICSRs in the EEA: 19-21 May 2014, London, UK","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-05-07T11:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/overview-eudravigilance-training-electronic-reporting-icsrs-eea-19-21-may-2014-london-uk_en.pdf"},
    {"id":"29946","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hamamelis virginiana L., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"EMEA/HMPC/582863/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-hamamelis-virginiana-l-folium_en.pdf"},
    {"id":"29947","name":"Losartan: List of nationally authorised medicinal products - PSUSA/00001912/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T15:19:00Z","last_updated_date":"2018-05-23T15:21:24Z","reference_number":"EMA/309956/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/losartan-list-nationally-authorised-medicinal-products-psusa00001912201709_en.pdf"},
    {"id":"29948","name":"Public statement on Zenapax: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-01-16T01:00:00Z","last_updated_date":"2009-02-13T01:00:00Z","reference_number":"EMEA/683765/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zenapax-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"29949","name":"Presentation - Day 2: Limbal stem cell therapy: industry view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-limbal-stem-cell-therapy-industry-view_en.pdf"},
    {"id":"29951","name":"Guideline on missing data in confirmatory clinical trials","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-09-20T02:00:00Z","last_updated_date":"2010-09-20T02:00:00Z","reference_number":"EMA/CPMP/EWP/1776/99 Rev. 1 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-missing-data-confirmatory-clinical-trials_en.pdf"},
    {"id":"29952","name":"EU/3/05/277: Public summary of positive opinion for orphan designation of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-04T02:00:00Z","last_updated_date":"2017-05-17T12:30:00Z","reference_number":"EMEA/COMP/123054/2005 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305277-public-summary-positive-opinion-orphan-designation-3-5-2-fluoro-phenyl-124oxadiazole-3-yl-benzoic-acid-treatment-cystic-fibrosis_en.pdf"},
    {"id":"29953","name":"EU/3/16/1822: Public summary of opinion on orphan designation: Pentosan polysulfate sodium for the treatment of interstitial cystitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/5068/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161822-public-summary-opinion-orphan-designation-pentosan-polysulfate-sodium-treatment-interstitial-cystitis_en.pdf"},
    {"id":"29957","name":"INS-GCP-1 procedure for coordinating good-clinical-practice inspections requested by the CHMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2014-05-23T18:00:00Z","reference_number":"EMEA/INS/GCP/197225/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ins-gcp-1-procedure-coordinating-good-clinical-practice-inspections-requested-chmp_en.pdf"},
    {"id":"29959","name":"Agenda - Tenth industry stakeholder platform on the operation of EU pharmacovigilance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T17:00:00Z","last_updated_date":"2017-02-02T17:00:00Z","reference_number":"EMA/42931/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-tenth-industry-stakeholder-platform-operation-eu-pharmacovigilance_en.pdf"},
    {"id":"29965","name":"Exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-03T01:00:00Z","last_updated_date":"2017-03-03T01:00:00Z","reference_number":"EMA/CHMP/474782/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/exenatide-powder-and-solvent-prolonged-release-suspension-injection-2-mg-and-powder-and-solvent-prolonged-release-suspension-injection-pre-filled-pen-2-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"29966","name":"Work instructions for how to create reports from scientific memory database (SMD)","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T12:30:00Z","last_updated_date":"2011-11-18T12:30:00Z","reference_number":"WIN/INSP/2040","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-how-create-reports-scientific-memory-database-smd_en.pdf"},
    {"id":"29968","name":"EU/3/14/1317: Public summary of opinion on orphan designation: (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2014-10-01T02:00:00Z","reference_number":"EMA/COMP/433733/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141317-public-summary-opinion-orphan-designation-z-3-3-35-bistrifluoromethylphenyl-1h-124-triazol-1-yl-n-pyrazin-2-ylacrylohydrazide-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"29969","name":"Superseded Community herbal monograph on Gentiana Lutea L., radix  - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2010-03-08T01:00:00Z","last_updated_date":"2019-04-30T01:00:00Z","reference_number":"EMA/HMPC/578324/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-gentiana-lutea-l-radix-first-version_en.pdf"},
    {"id":"29972","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 20 to 22 May 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-05-22T02:09:21Z","last_updated_date":"2003-05-22T02:09:21Z","reference_number":"EMEA/CPMP/2848/03/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-20-22-may-2003_en.pdf"},
    {"id":"29974","name":"Grindelia robusta Nutt., G. squarrosa Dunal, G. humilis Hook. et Arn., G. camporum Greene, herba","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/HMPC/160866/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/grindelia-robusta-nutt-g-squarrosa-dunal-g-humilis-hook-et-arn-g-camporum-greene-herba_en.pdf"},
    {"id":"29975","name":"Summary of transfers of appropriations in budget 2016 - Management Board meeting: 14-15 December 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T17:30:00Z","last_updated_date":"2016-12-19T17:30:00Z","reference_number":"EMA/MB/707314/2016","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2016-management-board-meeting-14-15-december-2016_en.pdf"},
    {"id":"29976","name":"Declaration of interests: Beatrice Fayl","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:06:45Z","last_updated_date":"2012-08-02T12:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-beatrice-fayl_en.pdf"},
    {"id":"29978","name":"Presentation - Application of ICH Q12 tools and enablers: post-approval lifecycle management protocols","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-17T01:00:00Z","last_updated_date":"2015-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-application-ich-q12-tools-and-enablers-post-approval-lifecycle-management-protocols_en.pdf"},
    {"id":"29979","name":"Iclusig Article-20 procedure - PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T14:00:00Z","last_updated_date":"2014-10-10T14:00:00Z","reference_number":"EMA/615086/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/iclusig-article-20-procedure-prac-recommends-further-measures-minimise-risk-blood-vessel-blockage-iclusig_en.pdf"},
    {"id":"29982","name":"Declaration of research interests (addendum) - Mark Turner","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-research-interests-addendum-mark-turner_en.pdf"},
    {"id":"29987","name":"Restharrow root: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T12:16:00Z","last_updated_date":"2017-03-09T12:16:00Z","reference_number":"EMA/815130/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/restharrow-root-summary-public_en.pdf"},
    {"id":"29989","name":"Guideline on the use of statistical signal-detection methods in the EudraVigilance data-analysis system","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-06-26T02:09:21Z","last_updated_date":"2016-12-21T11:32:00Z","reference_number":"EMEA/106464/2006 rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-use-statistical-signal-detection-methods-eudravigilance-data-analysis-system_en.pdf"},
    {"id":"29991","name":"Committee for Medicinal Products for Human Use (CHMP) - October 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-10-28T02:00:00Z","last_updated_date":"2010-10-28T02:00:00Z","reference_number":"EMA/CHMP/656448/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-october-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"29992","name":"Overview of comments received on draft guideline on similar biological medicinal products","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-12-02T10:25:00Z","last_updated_date":"2014-12-02T10:25:00Z","reference_number":"EMA/748294/2013","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-similar-biological-medicinal-products_en.pdf"},
    {"id":"29995","name":"Compassionate use for centralised medicinal products (according to Article 83 of regulation (EC) No 726/2004)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-03-20T01:00:00Z","last_updated_date":"2006-03-20T01:00:00Z","reference_number":"EMEA/CHMP/72144/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compassionate-use-centralised-medicinal-products-according-article-83-regulation-ec-no-7262004_en.pdf"},
    {"id":"29996","name":"EMA Management Board: highlights of October 2016 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T17:30:00Z","last_updated_date":"2016-10-07T17:30:00Z","reference_number":"EMA/662800/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-october-2016-meeting_en.pdf"},
    {"id":"29998","name":"Presentation - Overview of good-pharmacovigilance-practice modules on adverse drug reactions, periodic safety update reports, signal management and additional monitoring (Mick Foy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-good-pharmacovigilance-practice-modules-adverse-drug-reactions-periodic-safety-update-reports-signal-management-and-additional-monitoring-mick-foy_en.pdf"},
    {"id":"30001","name":"EU/3/03/157: Public summary of positive opinion for orphan designation of recombinant dog gastric lipase for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-10-29T00:00:00Z","last_updated_date":"2003-10-29T00:00:00Z","reference_number":"EMEA/COMP/1464/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303157-public-summary-positive-opinion-orphan-designation-recombinant-dog-gastric-lipase-treatment-cystic-fibrosis_en.pdf"},
    {"id":"30004","name":"Call for submission of scientific data on Tilia tomentosa Moench, flos (silver lime)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2010-03-22T01:00:00Z","last_updated_date":"2010-03-22T01:00:00Z","reference_number":"EMA/HMPC/160869/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-tilia-tomentosa-moench-flos-silver-lime_en.pdf"},
    {"id":"30007","name":"Presentation - Blood-brain-barrier maturation: Implications for drug development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-blood-brain-barrier-maturation-implications-drug-development_en.pdf"},
    {"id":"30009","name":"Testosterone Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-08T01:00:00Z","last_updated_date":"2015-01-08T01:00:00Z","reference_number":"EMEA/H/A-31/1396","document_url":"https://www.ema.europa.eu/en/documents/referral/testosterone-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/testosterone-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/testosterone-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/testosterone-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/testosterone-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/testosterone-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/testosterone-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/testosterone-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/testosterone-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/testosterone-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/testosterone-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/testosterone-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/testosterone-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/testosterone-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/testosterone-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/testosterone-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/testosterone-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/testosterone-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/testosterone-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/testosterone-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/testosterone-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/testosterone-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/testosterone-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"30010","name":"GCP compliance, Dr Katalina Mettke","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/gcp-compliance-dr-katalina-mettke_en.pdf"},
    {"id":"30011","name":"Presentation - Challenges in performing field trials to support efficacy: companion animal vaccines  (K. Hellmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T15:12:00Z","last_updated_date":"2017-11-15T15:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-performing-field-trials-support-efficacy-companion-animal-vaccines-k-hellmann_en.pdf-0"},
    {"id":"30012","name":"Business pipeline","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2015-05-18T18:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/business-pipeline_en.pdf"},
    {"id":"30013","name":"How to prepare PIP/Waiver dossier? - Anu Tummavuori-Liemann","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-11-16T00:09:21Z","last_updated_date":"2009-11-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/how-prepare-pipwaiver-dossier-anu-tummavuori-liemann_en.pdf"},
    {"id":"30015","name":"Template letter of intent for request of scientific advice - veterinary","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T13:24:00Z","last_updated_date":"2017-03-30T14:24:00Z","reference_number":"EMA/279341/2012","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-letter-intent-request-scientific-advice-veterinary_en.doc"},
    {"id":"30016","name":"Organisational matters - CHMP meeting 27-30 May 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T13:00:00Z","last_updated_date":"2013-06-07T13:00:00Z","reference_number":"EMA/CHMP/184574/2013","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-27-30-may-2013_en.pdf"},
    {"id":"30017","name":"CHMP post-authorisation summary of positive opinion for Pegasys (II-91)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-10-13T14:00:00Z","last_updated_date":"2017-10-13T14:00:00Z","reference_number":"EMA/CHMP/634272/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pegasys-ii-91_en.pdf"},
    {"id":"30018","name":"Agenda - PRAC draft agenda of meeting 7-10 January 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-01-09T20:00:00Z","last_updated_date":"2013-01-09T20:00:00Z","reference_number":"EMA/PRAC/731552/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-7-10-january-2013_en.pdf"},
    {"id":"30020","name":"Presentation - Taking CARs/TCRs from first-in-man trials to marketing authorisation – the view from a pharmaceutical developer (Stanley Frankel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-taking-carstcrs-first-man-trials-marketing-authorisation-view-pharmaceutical-developer-stanley-frankel_en.pdf"},
    {"id":"30022","name":"Draft assessment report on Carum carvi L., fructus and Carum carvi L. aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-12-22T17:15:00Z","last_updated_date":"2014-12-22T17:15:00Z","reference_number":"EMA/HMPC/715093/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-carum-carvi-l-fructus-and-carum-carvi-l-aetheroleum_en.pdf"},
    {"id":"30023","name":"Overview of comments received on reflection paper - EPAR summary for the public","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-01-26T01:00:00Z","last_updated_date":"2006-01-26T01:00:00Z","reference_number":"EMEA/20722/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-reflection-paper-epar-summary-public_en.pdf"},
    {"id":"30025","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-19 September 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-10-12T13:48:00Z","last_updated_date":"2017-10-12T13:48:00Z","reference_number":"EMA/HMPC/637548/2017 FINAL","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-18-19-september-2017_en.pdf"},
    {"id":"30027","name":"Draft list of references supporting the assessment of Glycine max (L.) Merr., lecithin","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-07-27T15:40:00Z","last_updated_date":"2016-07-27T15:40:00Z","reference_number":"EMA/HMPC/338889/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-glycine-max-l-merr-lecithin_en.pdf"},
    {"id":"30030","name":"Guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-11-21T10:19:00Z","last_updated_date":"2017-11-21T10:19:00Z","reference_number":"EMA/CHMP/598082/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-medicinal-products-treatment-autism-spectrum-disorder-asd_en.pdf"},
    {"id":"30031","name":"Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/MB/170391/2009/Rev.4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/rules-implementation-council-regulation-ec-no-29795-fees-payable-european-medicines-agency-and-other-measures_en.pdf"},
    {"id":"30032","name":"Organisation chart of the European Medicines Agency, as of 1 September","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-29T02:00:00Z","last_updated_date":"2016-07-29T02:00:00Z","reference_number":"1 September 2016","document_url":"https://www.ema.europa.eu/en/documents/other/organisation-chart-european-medicines-agency-1-september_en.pdf"},
    {"id":"30033","name":"European Medicines Agency letter to European Ombudsman regarding proactive publication of and access to clinical trial data","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-22T19:35:00Z","last_updated_date":"2014-05-22T19:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-letter-european-ombudsman-regarding-proactive-publication-and-access-clinical-trial-data_en.pdf"},
    {"id":"30034","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations (ICH) guideline Q8 (R2) on pharmaceutical development - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-06-01T02:00:00Z","last_updated_date":"2014-05-28T17:30:00Z","reference_number":"EMA/CHMP/ICH/167068/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-considerations-ich-guideline-q8-r2-pharmaceutical-development-step-5_en.pdf"},
    {"id":"30036","name":"Presentation - MAHs access to EudraVigilance (Rodrigo Postigo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-25T16:03:00Z","last_updated_date":"2017-07-25T16:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mahs-access-eudravigilance-rodrigo-postigo_en.pdf"},
    {"id":"30041","name":"Superseded assessment report on Juniperi pseudo-fructus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-02-16T01:00:00Z","last_updated_date":"2023-06-13T01:00:00Z","reference_number":"EMA/HMPC/441930/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-juniperi-pseudo-fructus_en.pdf"},
    {"id":"30044","name":"Public statement on efficacy and safety concerns regarding the co-administration of tenofovir disoproxil fumarate (TDF, Viread) and didanosine (ddI, Videx)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-03-03T00:09:21Z","last_updated_date":"2005-03-03T00:09:21Z","reference_number":"EMEA/62331/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-efficacy-and-safety-concerns-regarding-co-administration-tenofovir-disoproxil-fumarate-tdf-viread-and-didanosine-ddi-videx_en.pdf"},
    {"id":"30045","name":"Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-04-15T18:30:00Z","last_updated_date":"2014-04-15T18:30:00Z","reference_number":"EMA/PRAC/222346/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/interim-guidance-enhanced-safety-surveillance-seasonal-influenza-vaccines-eu_en.pdf"},
    {"id":"30050","name":"Overview of comments received on 'Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-12-22T16:30:00Z","last_updated_date":"2014-12-22T16:30:00Z","reference_number":"EMA/CHMP/BPWP/697285/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-core-smpc-human-plasma-derived-and-recombinant-coagulation-factor-ix-products_en.pdf"},
    {"id":"30051","name":"Meeting highlights from the Paediatric Committee: 17- 19 September 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-24T02:00:00Z","last_updated_date":"2008-09-24T02:00:00Z","reference_number":"EMEA/PDCO/493761/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-17-19-september-2008_en.pdf"},
    {"id":"30052","name":"Rabbit anti-human thymocyte (powder for solution for\n\ninfusion): List of nationally authorised medicinal products - PSUSA/00010184/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-04T12:00:00Z","last_updated_date":"2016-10-17T19:31:37Z","reference_number":"EMA/592453/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabbit-anti-human-thymocyte-powder-solution-infusion-list-nationally-authorised-medicinal-products-psusa00010184201412_en.pdf"},
    {"id":"30053","name":"G Rassi downloadable ZIP File","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-28T02:00:00Z","last_updated_date":"2011-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/g-rassi-downloadable-zip-file_en.zip"},
    {"id":"30057","name":"Public statement on Zartra (imiquimod): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2002-07-31T02:00:00Z","last_updated_date":"2002-07-31T02:00:00Z","reference_number":"EMEA/12594/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zartra-imiquimod-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"30058","name":"EU/3/16/1741: Public summary of positive opinion for orphan designation of adeno-associated viral vector serotype 5 containing the human RLBP1 gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/620229/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161741-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-serotype-5-containing-human-rlbp1-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"30060","name":"Sales of antibiotics for animal use decrease by 13% in Europe between 2011 and 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-16T02:00:00Z","last_updated_date":"2017-10-16T02:00:00Z","reference_number":"EMA/658373/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/sales-antibiotics-animal-use-decrease-13-europe-between-2011-and-2015_en.pdf"},
    {"id":"30061","name":"Focetria: Product information as recommended by the CHMP on 22 April 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2010-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/focetria-product-information-recommended-chmp-22-april-2010_en.pdf"},
    {"id":"30062","name":"Presentation - FDA incentives (John D. Milto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-incentives-john-d-milto_en.pdf"},
    {"id":"30063","name":"EU/3/04/235: Public summary of positive opinion for orphan designation of recombinant human insulin-like growth factor-I/recombinant human insulin-like growth factor binding protein-3 for treatment of Type B extreme insu...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-20T00:00:00Z","last_updated_date":"2011-06-22T01:00:00Z","reference_number":"EMEA/COMP/77803/2004 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304235-public-summary-positive-opinion-orphan-designation-recombinant-human-insulin-growth-factor-irecombinant-human-insulin-growth-factor-binding-protein-3-treatment-type-b-extreme-insu_en.pdf"},
    {"id":"30064","name":"Presentation - Transparency in Europe: patients and doctors (Dominic Way and Frederic Bouder)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-transparency-europe-patients-and-doctors-dominic-way-and-frederic-bouder_en.pdf"},
    {"id":"30065","name":"Presentation - EU US mutual recognition agreement (B.Cuddy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-18T02:00:00Z","last_updated_date":"2017-09-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-us-mutual-recognition-agreement-bcuddy_en.pdf"},
    {"id":"30069","name":"EU/3/06/356: Public summary of positive opinion for orphan designation of 4-amino-5-oxo-4 (pyridinium-1-ylmethyl) proline for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-24T02:00:00Z","last_updated_date":"2011-04-04T02:00:00Z","reference_number":"EMEA/COMP/26820/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306356-public-summary-positive-opinion-orphan-designation-4-amino-5-oxo-4-pyridinium-1-ylmethyl-proline-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"30072","name":"Presentation - Perspective on the implementation of a pharmacovigilance system","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-03T17:30:00Z","last_updated_date":"2012-05-03T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-perspective-implementation-pharmacovigilance-system_en.pdf"},
    {"id":"30073","name":"Paediatric Pharmacovigilance, Dr Dirk Mentzer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/paediatric-pharmacovigilance-dr-dirk-mentzer_en.pdf"},
    {"id":"30074","name":"Presentation - Evidence-based guidance for risk communication planning (Priya Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evidence-based-guidance-risk-communication-planning-priya-bahri_en.pdf"},
    {"id":"30076","name":"Tulathromycin: Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-01-01T00:09:21Z","last_updated_date":"2004-01-01T00:09:21Z","reference_number":"EMEA/MRL/894/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tulathromycin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30077","name":"CHMP summary of positive opinion for Rivastigmine Actavis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-04-15T02:00:00Z","last_updated_date":"2011-04-15T02:00:00Z","reference_number":"EMA/98238/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rivastigmine-actavis_en.pdf"},
    {"id":"30080","name":"Questions and answers on the withdrawal of the guideline on pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals (3BS11A)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T16:30:00Z","last_updated_date":"2015-02-04T15:30:00Z","reference_number":"EMEA/CHMP/SWP/1991104/2014 corr 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-withdrawal-guideline-pharmacokinetics-and-metabolic-studies-safety-evaluation-new-medicinal-products-animals-3bs11a_en.pdf"},
    {"id":"30081","name":"Cyfluthrin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T01:00:00Z","last_updated_date":"1997-11-01T01:00:00Z","reference_number":"EMEA/MRL/028/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cyfluthrin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30082","name":"Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:40:00Z","last_updated_date":"2017-01-20T16:40:00Z","reference_number":"EMA/36362/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/bemiparin-list-nationally-authorised-medicinal-products-psusa00000312201604_en.pdf"},
    {"id":"30083","name":"United States Food and Drug Administration - European Medicines Agency: Good-clinical-practice initiative: Frequently asked questions and answers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-08T02:00:00Z","last_updated_date":"2010-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/united-states-food-and-drug-administration-european-medicines-agency-good-clinical-practice-initiative-frequently-asked-questions-and-answers_en.pdf"},
    {"id":"30084","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2016 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-02-03T10:45:00Z","last_updated_date":"2016-02-03T10:45:00Z","reference_number":"EMA/68141/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-january-2016-meeting_en.pdf"},
    {"id":"30085","name":"In vitro tests and experimental animal models for investigation of the allergenic potential of biotechnology-derived proteins - Attila Bacsi","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-09-04T02:09:21Z","last_updated_date":"2007-09-04T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/vitro-tests-and-experimental-animal-models-investigation-allergenic-potential-biotechnology-derived-proteins-attila-bacsi_en.pdf"},
    {"id":"30089","name":"Presentation - How are medicines evaluated at the European Medicines Agency (part 2)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-are-medicines-evaluated-european-medicines-agency-part-2_en.pdf"},
    {"id":"30090","name":"Superseded overview of comments received on community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2010-09-02T02:00:00Z","last_updated_date":"2010-09-02T02:00:00Z","reference_number":"EMA/HMPC/132077/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos_en.pdf"},
    {"id":"30092","name":"EU/3/14/1304: Public summary of opinion on orphan designation: Eculizumab for the treatment myasthenia gravis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T02:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/COMP/374393/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141304-public-summary-opinion-orphan-designation-eculizumab-treatment-myasthenia-gravis_en.pdf"},
    {"id":"30093","name":"European Patients’ Academy on Therapeutic Innovation (J. Geissler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-patients-academy-therapeutic-innovation-j-geissler_en.pdf"},
    {"id":"30094","name":"EU/3/17/1845: Public summary of opinion on orphan designation: Thalidomide for the treatment of hereditary haemorrhagic telangiectasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/72429/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171845-public-summary-opinion-orphan-designation-thalidomide-treatment-hereditary-haemorrhagic-telangiectasia_en.pdf"},
    {"id":"30098","name":"Contract 2006/118-594: Multi-beneficiary programme on participation of Croatia and Turkey in certain Community agencies in 2006 and 2007: Third progress report to the European Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2007-08-21T02:09:21Z","last_updated_date":"2007-08-21T02:09:21Z","reference_number":"EMEA/386242/2007","document_url":"https://www.ema.europa.eu/en/documents/report/contract-2006118-594-multi-beneficiary-programme-participation-croatia-and-turkey-certain-community-agencies-2006-and-2007-third-progress-report-european-commission_en.pdf"},
    {"id":"30101","name":"Assessment report on Plantago ovata Forssk., seminis tegumentum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/165838/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/assessment-report-plantago-ovata-forssk-seminis-tegumentum_en.pdf"},
    {"id":"30102","name":"Presentation - Qualification of the Simcyp platform for the intended purposes(Masoud Jamei)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qualification-simcyp-platform-intended-purposesmasoud-jamei_en.pdf"},
    {"id":"30103","name":"Analysis of Performance Indicators for Initial Applications/Full Applications The 2007 trends: EMEA analysis - Francesco Pignatti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/analysis-performance-indicators-initial-applicationsfull-applications-2007-trends-emea-analysis-francesco-pignatti_en.pdf"},
    {"id":"30105","name":"EU/3/17/1915: Public summary of opinion on orphan designation : 2-[N-(2-hydroxyethyl)]-N-(4-methoxybenzenesulfonyl)]amino-N-(4-chlorocinnamyl)-N-methylbenzylamine for the treatment of Charcot-Marie-Tooth disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T11:37:00Z","last_updated_date":"2018-01-08T11:37:00Z","reference_number":"EMA/620625/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171915-public-summary-opinion-orphan-designation-2-n-2-hydroxyethyl-n-4-methoxybenzenesulfonylamino-n-4-chlorocinnamyl-n-methylbenzylamine-treatment-charcot-marie-tooth-disease_en.pdf"},
    {"id":"30107","name":"Nimesulide (systemic formulations): List of nationally authorised medicinal products - PSUSA/00009236/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-11T02:00:00Z","last_updated_date":"2016-10-18T12:37:31Z","reference_number":"EMA/256049/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/nimesulide-systemic-formulations-list-nationally-authorised-medicinal-products-psusa00009236201506_en.pdf"},
    {"id":"30108","name":"Committee for Medicinal Products for Human Use (CHMP) - February 2009 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-04-29T02:00:00Z","last_updated_date":"2009-04-29T02:00:00Z","reference_number":"EMEA/97795/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-february-2009-plenary-meeting-monthly-report_en.pdf"},
    {"id":"30109","name":"Annex B3 - Candidate host Member States’ offers to relocate the European Medicines Agency - EMA comments on other criteria essential to ensure that EMA remains operational to guarantee business continuity (applied method...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T20:15:00Z","last_updated_date":"2017-10-03T20:15:00Z","reference_number":"EMA/606600/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annex-b3-candidate-host-member-states-offers-relocate-european-medicines-agency-ema-comments-other-criteria-essential-ensure-ema-remains-operational-guarantee-business-continuity-applied-method_en.pdf"},
    {"id":"30113","name":"CHMP summary of opinion for Blincyto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/571712/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-blincyto_en.pdf"},
    {"id":"30117","name":"Augmentin - Article 30 - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/augmentin-article-30-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/augmentin-article-30-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/augmentin-article-30-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/augmentin-article-30-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/augmentin-article-30-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/augmentin-article-30-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/augmentin-article-30-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/augmentin-article-30-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/augmentin-article-30-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/augmentin-article-30-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/augmentin-article-30-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/augmentin-article-30-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/augmentin-article-30-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/augmentin-article-30-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/augmentin-article-30-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/augmentin-article-30-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/augmentin-article-30-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/augmentin-article-30-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/augmentin-article-30-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/augmentin-article-30-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/augmentin-article-30-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/augmentin-article-30-annex-i_sv.pdf"}},
    {"id":"30118","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Mercaptopurine Nova Laboratories (mercaptopurine (oral suspension)) for the treatment of acute lymphoblastic leukaemia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-04-10T17:13:00Z","last_updated_date":"2012-04-10T17:13:00Z","reference_number":"EMA/COMP/733334/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-mercaptopurine-nova-laboratories-mercaptopurine-oral-suspension-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"30120","name":"Presentation - Session 3.9: Potential interaction with Enpr-EMA networks","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-39-potential-interaction-enpr-ema-networks_en.pdf"},
    {"id":"30122","name":"Regulatory requirements to prevent viral shedding during gene therapy in Japan - Teruyo Arato, Daisuke Maeda, Teruhide Yamaguchi","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/regulatory-requirements-prevent-viral-shedding-during-gene-therapy-japan-teruyo-arato-daisuke-maeda-teruhide-yamaguchi_en.pdf"},
    {"id":"30123","name":"CVMP opinions and evaluations started for medicines for veterinary use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-20T01:00:00Z","last_updated_date":"2014-01-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cvmp-opinions-and-evaluations-started-medicines-veterinary-use_en.pdf"},
    {"id":"30124","name":"Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-08-01T02:00:00Z","last_updated_date":"2011-08-01T02:00:00Z","reference_number":"EMA/CHMP/BPWP/144533/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-viii-products-first-version_en.pdf"},
    {"id":"30125","name":"Start of community reviews - CHMP meeting of 07-10 November 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/702479/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-07-10-november-2016_en.pdf"},
    {"id":"30128","name":"Committee for veterinary medicinal products: 60th meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-11-10T12:39:21Z","last_updated_date":"2000-11-10T12:39:21Z","reference_number":"EMEA/CVMP/870/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-60th-meeting_en.pdf"},
    {"id":"30129","name":"Review of emergency contraceptives started","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T12:59:55Z","last_updated_date":"2014-01-24T12:59:55Z","reference_number":"EMA/36862/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-emergency-contraceptives-started_en.pdf"},
    {"id":"30133","name":"Withdrawal letter: Opdivo (II/0039)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-opdivo-ii0039_en.pdf"},
    {"id":"30134","name":"Guideline on active substance master file procedure - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-04-15T02:00:00Z","last_updated_date":"2005-04-15T02:00:00Z","reference_number":"CPMP/QWP/227/02 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-active-substance-master-file-procedure-revision-1_en.pdf"},
    {"id":"30136","name":"Superseded overview of comments received on Community herbal monograph on Achillea millefolium L., herba - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-09-30T02:00:00Z","last_updated_date":"2011-09-30T02:00:00Z","reference_number":"EMA/HMPC/238500/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-achillea-millefolium-l-herba-first-version_en.pdf"},
    {"id":"30137","name":"CHMP post-authorisation summary of positive opinion for  Stelara","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T14:00:00Z","last_updated_date":"2016-09-16T14:00:00Z","reference_number":"EMA/CHMP/582037/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stelara_en.pdf-2"},
    {"id":"30139","name":"Superseded opinion of the Committee on Herbal Medicinal products on a community herbal monograph on Aesculus Hippocastanum L., semen - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2020-04-23T02:00:00Z","reference_number":"EMEA/HMPC/438817/2009EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-aesculus-hippocastanum-l-semen-first-version_en.pdf"},
    {"id":"30140","name":"EU/3/01/036: Public summary of positive opinion for orphan designation of recombinant human C1-inhibitor for the treatment of angioedema caused by C1 inhibitor deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/182/04 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301036-public-summary-positive-opinion-orphan-designation-recombinant-human-c1-inhibitor-treatment-angioedema-caused-c1-inhibitor-deficiency_en.pdf"},
    {"id":"30145","name":"Guideline on the investigation of medicinal products in the term and preterm neonate - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/536810/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-medicinal-products-term-and-preterm-neonate-first-version_en.pdf"},
    {"id":"30146","name":"Presentation - Scientific advice on quality aspects – key considerations, Prof. Dieter Deforce","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advice-quality-aspects-key-considerations-prof-dieter-deforce_en.pdf"},
    {"id":"30148","name":"CHMP highlights - October 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-highlights-october-2015_en.pdf"},
    {"id":"30149","name":"COMP meeting report on the review of applications for orphan designation: March 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T14:13:00Z","last_updated_date":"2017-03-30T14:13:00Z","reference_number":"EMA/COMP/140585/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-march-2017_en.pdf"},
    {"id":"30151","name":"EU/3/08/578: Public summary of positive opinion for orphan designation of\n\ncysteamine hydrochloride for the treatment of cystinosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/488783/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308578-public-summary-positive-opinion-orphan-designation-cysteamine-hydrochloride-treatment-cystinosis_en.pdf"},
    {"id":"30152","name":"Glubrava: Product Information as approved by the CHMP on 20 october 2011, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/glubrava-product-information-approved-chmp-20-october-2011-pending-endorsement-european-commission_en.pdf"},
    {"id":"30153","name":"European Medicines Agency launches adaptive licensing pilot project","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-19T01:00:00Z","last_updated_date":"2014-03-19T01:00:00Z","reference_number":"EMA/430892/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-adaptive-licensing-pilot-project_en.pdf"},
    {"id":"30157","name":"Scientific advice and protocol assistance - Adopted during the CHMP meeting 16-19 July 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T14:00:00Z","last_updated_date":"2012-07-20T14:00:00Z","reference_number":"EMA/487646/2012","document_url":"https://www.ema.europa.eu/en/documents/other/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-16-19-july-2012_en.pdf"},
    {"id":"30158","name":"Chlorocresol (4-chloro-3-methylphenol): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-03-01T01:00:00Z","last_updated_date":"1996-03-01T01:00:00Z","reference_number":"EMEA/MRL/074/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/chlorocresol-4-chloro-3-methylphenol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30163","name":"Agenda - Committee for Advanced Therapies stakeholders workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T18:15:02Z","last_updated_date":"2011-11-30T18:15:02Z","reference_number":"EMA/CAT/929342/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-committee-advanced-therapies-stakeholders-workshop_en.pdf"},
    {"id":"30164","name":"Gadolinium Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-03-18T01:00:00Z","reference_number":"EMA/200364/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-review-started_en.pdf"},
    {"id":"30165","name":"CVMP summary of positive opinion for Parvoduk","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-02-14T01:00:00Z","last_updated_date":"2019-04-15T01:00:00Z","reference_number":"EMA/CVMP/60159/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-parvoduk_en.pdf"},
    {"id":"30168","name":"EU/3/05/302: Public summary of positive opinion for orphan designation of extract of Sorghum bicolour leaf, Pterocarpus osun stem, Piper guineense seed and Caryophylli flower for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-27T02:00:00Z","last_updated_date":"2005-10-27T02:00:00Z","reference_number":"EMEA/COMP/241141/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305302-public-summary-positive-opinion-orphan-designation-extract-sorghum-bicolour-leaf-pterocarpus-osun-stem-piper-guineense-seed-and-caryophylli-flower-treatment-sickle-cell-disease_en.pdf"},
    {"id":"30171","name":"News bulletin for small and medium-sized enterprises - Issue 29","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-10-17T18:20:00Z","last_updated_date":"2014-10-17T18:20:00Z","reference_number":"Issue 29","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-29_en.pdf"},
    {"id":"30172","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation : Natpar (parathyroid hormone) for the treatment of hypoparathyroidism","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-04-26T19:19:00Z","last_updated_date":"2017-04-26T19:19:00Z","reference_number":"EMA/172380/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-natpar-parathyroid-hormone-treatment-hypoparathyroidism_en.pdf"},
    {"id":"30174","name":"Overview of comments received on Community herbal monograph on Juniperus communis L., aetheroleum","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMA/HMPC/563725/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-juniperus-communis-l-aetheroleum_en.pdf"},
    {"id":"30175","name":"EU/3/05/295: Public summary of positive opinion for orphan designation of hepatitis C immunoglobulin for the prevention of recurrent hepatitis C virus induced liver disease in liver transplant recipients","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2008-08-18T02:00:00Z","reference_number":"EMEA/COMP/193391/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305295-public-summary-positive-opinion-orphan-designation-hepatitis-c-immunoglobulin-prevention-recurrent-hepatitis-c-virus-induced-liver-disease-liver-transplant-recipients_en.pdf"},
    {"id":"30176","name":"Presentation - Session 2: What can we do now and what are the gaps in our knowledge? The direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) (Antonio Gà³mez-Outes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-13T17:00:00Z","last_updated_date":"2016-01-13T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-what-can-we-do-now-and-what-are-gaps-our-knowledge-direct-factor-xa-inhibitors-rivaroxaban-apixaban-edoxaban-antonio-ga3mez-outes_en.pdf"},
    {"id":"30177","name":"Presentation - Introduction and goals of the workshop (Jean-Louis Robert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-and-goals-workshop-jean-louis-robert_en.pdf"},
    {"id":"30181","name":"Committee for medicinal products for veterinary use: Meeting of 11-13 November 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:29:21Z","last_updated_date":"2008-11-14T00:29:21Z","reference_number":"EMEA/CVMP/585012/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-11-13-november-2008_en.pdf"},
    {"id":"30184","name":"EMA tracking tool: relocation to Amsterdam - Main milestones","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-03-05T11:00:00Z","last_updated_date":"2020-04-30T17:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-tracking-tool-relocation-amsterdam-main-milestones_en.pdf"},
    {"id":"30187","name":"C(2002) 355: Public summary of negative opinion for orphan designation of ibritumomab tiuxetan for use with 90Yttrium for the treatment of B-cell non-Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/73/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/c2002-355-public-summary-negative-opinion-orphan-designation-ibritumomab-tiuxetan-use-90yttrium-treatment-b-cell-non-hodgkins-lymphoma_en.pdf"},
    {"id":"30191","name":"Questionnaire on eligibility to become an interested party to Committee for Advanced Therapies (CAT)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:09:21Z","last_updated_date":"2009-06-23T02:09:21Z","reference_number":"EMEA/CAT/393507/2009","document_url":"https://www.ema.europa.eu/en/documents/template-form/questionnaire-eligibility-become-interested-party-committee-advanced-therapies-cat_en.doc"},
    {"id":"30192","name":"CVMP monthly report of application procedures, guidelines and related documents: July 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-08-21T13:40:00Z","last_updated_date":"2012-08-21T13:40:00Z","reference_number":"EMA/483316/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-july-2012_en.pdf"},
    {"id":"30193","name":"Overview of applications for mMarketing authorisation - Recent experience in quality assessment - Dr Cornelia Nopitsch-Mai","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/overview-applications-mmarketing-authorisation-recent-experience-quality-assessment-dr-cornelia-nopitsch-mai_en.pdf"},
    {"id":"30194","name":"Valproate and related substances Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"EMA/620381/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-and-related-substances-article-31-referral-review-started_en.pdf"},
    {"id":"30195","name":"Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T02:00:00Z","last_updated_date":"2016-10-17T18:51:25Z","reference_number":"EMA/544752/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/isoniazid-list-nationally-authorised-medicinal-products-psusa00001789201411_en.pdf"},
    {"id":"30196","name":"Agenda - Expert meeting on clinical investigation of new drugs for the treatment of chronic hepatitis C in the paediatric population","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T03:00:00Z","last_updated_date":"2011-07-12T03:00:00Z","reference_number":"EMA/97974/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-expert-meeting-clinical-investigation-new-drugs-treatment-chronic-hepatitis-c-paediatric-population_en.pdf"},
    {"id":"30197","name":"Abbott Laboratories Limited withdraws its marketing authorisation application for Ozespa (briakinumab)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-01-17T01:00:00Z","last_updated_date":"2011-01-17T01:00:00Z","reference_number":"EMA/40297/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/abbott-laboratories-limited-withdraws-its-marketing-authorisation-application-ozespa-briakinumab_en.pdf"},
    {"id":"30198","name":"Joint EMA/HMA Veterinary Vaccine Availability Action Plan - Analysis of industry recommendations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-06-06T17:43:00Z","last_updated_date":"2017-06-06T17:43:00Z","reference_number":"EMA/239617/2016","document_url":"https://www.ema.europa.eu/en/documents/other/joint-emahma-veterinary-vaccine-availability-action-plan-analysis-industry-recommendations_en.pdf"},
    {"id":"30199","name":"Note for guidance: Requirements for combined veterinary vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"CVMP/IWP/52/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-requirements-combined-veterinary-vaccines_en.pdf"},
    {"id":"30201","name":"CVMP post-authorisation summary of positive opinion for Advocate","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-07-10T17:00:00Z","last_updated_date":"2015-07-10T17:00:00Z","reference_number":"EMA/CVMP/467847/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-advocate_en.pdf-0"},
    {"id":"30202","name":"EU/3/12/1090: Public summary of opinion on orphan designation: Recombinant human monoclonal antibody of the IgG1 kappa class against prostate stem-cell antigen for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMA/COMP/1814/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121090-public-summary-opinion-orphan-designation-recombinant-human-monoclonal-antibody-igg1-kappa-class-against-prostate-stem-cell-antigen-treatment-pancreatic-cancer_en.pdf"},
    {"id":"30204","name":"Guideline on the clinical development of medicinal products for the treatment of HIV infection - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"EMEA/CPMP/EWP/633/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-medicinal-products-treatment-hiv-infection-revision-2_en.pdf"},
    {"id":"30205","name":"Gamithromycin (bovine species):  European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-21T01:00:00Z","last_updated_date":"2013-11-21T01:00:00Z","reference_number":"EMEA/CVMP/268818/2007","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gamithromycin-bovine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"30206","name":"New medicine to help in the fight against antimicrobial resistance","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T14:00:02Z","last_updated_date":"2016-04-29T14:00:02Z","reference_number":"EMA/CHMP/291057/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-help-fight-against-antimicrobial-resistance_en.pdf"},
    {"id":"30207","name":"Overview of comments received on draft guideline on active substance master file procedure - Revision 3","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-13T13:00:00Z","last_updated_date":"2012-07-13T13:00:00Z","reference_number":"EMA/314313/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-active-substance-master-file-procedure-revision-3_en.pdf"},
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    {"id":"30221","name":"Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA (San Marino)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-01-26T16:30:00Z","last_updated_date":"2017-01-26T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-icsrs-eea-san-marino_en.pdf"},
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    {"id":"30337","name":"Tysabri Article-20 procedure - Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-12T01:00:00Z","last_updated_date":"2016-02-12T01:00:00Z","reference_number":"EMA/85655/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/tysabri-article-20-procedure-updated-recommendations-minimise-risk-rare-brain-infection-pml-tysabri_en.pdf"},
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    {"id":"30380","name":"Interferon alpha-2a: List of nationally authorised medicinal products - PSUSA/00009197/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-03T15:55:00Z","last_updated_date":"2018-04-03T16:01:37Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/interferon-alpha-2a-list-nationally-authorised-medicinal-products-psusa00009197201706_en.pdf"},
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    {"id":"30387","name":"Presentation - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting - PCWP 10 year anniversary: Its finally here! (Maria Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-pcwp-10-year-anniversary-its-finally-here-maria-mavris_en.pdf"},
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    {"id":"30389","name":"Revised reflection paper on the use of third- and fourth-generation cephalosporins in food-producing animals in the European Union: Development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2009-03-16T01:00:00Z","reference_number":"EMEA/CVMP/SAGAM/81730/2006-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-reflection-paper-use-third-and-fourth-generation-cephalosporins-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
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    {"id":"30430","name":"European Medicines Agency tightens conflicts-of-interests policies with immediate effect","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-04-03T21:01:03Z","last_updated_date":"2012-04-03T21:01:03Z","reference_number":"EMA/235722/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-tightens-conflicts-interests-policies-immediate-effect_en.pdf"},
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    {"id":"30484","name":"EU/3/14/1310: Public summary of opinion on orphan designation: (3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate for the treatment of Fabry disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/COMP/431240/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141310-public-summary-opinion-orphan-designation-3s-1-azabicyclo222oct-3-yl2-2-4-fluorophenyl-13-thiazol-4-ylpropan-2-ylcarbamate-treatment-fabry-disease_en.pdf"},
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    {"id":"30490","name":"Committee for veterinary medicinal products: 53rd meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-03-09T12:49:21Z","last_updated_date":"2000-03-09T12:49:21Z","reference_number":"EMEA/CVMP/189/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-53rd-meeting_en.pdf"},
    {"id":"30491","name":"CHMP ORGAM agenda for the meeting on 18 June 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-07-31T16:10:00Z","last_updated_date":"2018-07-31T16:10:00Z","reference_number":"EMA/CHMP/412142/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-18-june-2018_en.pdf"},
    {"id":"30494","name":"CVMP assessment report regarding the request for an opinion under Article-30(3) of Regulation (EC) No 726/2004 in relation to the potential risk for the consumer resulting from the use of lidocaine in food producing spec...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-04-22T14:00:00Z","last_updated_date":"2015-04-22T14:00:00Z","reference_number":"EMA/CVMP/118717/2015","document_url":"https://www.ema.europa.eu/en/documents/report/cvmp-assessment-report-regarding-request-opinion-under-article-303-regulation-ec-no-7262004-relation-potential-risk-consumer-resulting-use-lidocaine-food-producing-spec_en.pdf"},
    {"id":"30497","name":"Template for registering new active substance on EUTCT","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-07-13T15:58:00Z","last_updated_date":"2023-01-10T11:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-registering-new-active-substance-eutct_en.xlsx"},
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    {"id":"30500","name":"Summary of opinion for Portrazza","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T13:00:00Z","last_updated_date":"2021-07-27T13:52:00Z","reference_number":"EMA/CHMP/756429/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/summary-opinion-portrazza_en.pdf"},
    {"id":"30501","name":"Note for guidance on clinical evaluation of new vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-05-19T02:00:00Z","last_updated_date":"1999-05-19T02:00:00Z","reference_number":"CPMP/EWP/463/97","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-evaluation-new-vaccines_en.pdf"},
    {"id":"30502","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Diclofenac sodium/thiocolchicoside for treatment of musculoskeletal and connective tissue pain","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T12:15:00Z","last_updated_date":"2014-12-12T12:15:00Z","reference_number":"EMA/757055/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-diclofenac-sodiumthiocolchicoside-treatment-musculoskeletal-and-connective-tissue-pain_en.pdf"},
    {"id":"30503","name":"Cromoglicic acid : List of nationally authorised medicinal products - PSUSA/00000883/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T15:40:00Z","last_updated_date":"2017-10-31T16:01:55Z","reference_number":"EMA/663700/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cromoglicic-acid-list-nationally-authorised-medicinal-products-psusa00000883201702_en.pdf"},
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    {"id":"30508","name":"Seresto Article-13 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T02:00:00Z","last_updated_date":"2018-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/seresto-article-13-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/seresto-article-13-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/seresto-article-13-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/seresto-article-13-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/seresto-article-13-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/seresto-article-13-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/seresto-article-13-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/seresto-article-13-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/seresto-article-13-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/seresto-article-13-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/seresto-article-13-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/seresto-article-13-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/seresto-article-13-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/seresto-article-13-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/seresto-article-13-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/seresto-article-13-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/seresto-article-13-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/seresto-article-13-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/seresto-article-13-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/seresto-article-13-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/seresto-article-13-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/seresto-article-13-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/seresto-article-13-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"30509","name":"CHMP summary of positive opinion for Budesonide / Formoterol Teva Pharma B.V.","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T16:18:00Z","last_updated_date":"2017-01-30T15:18:00Z","reference_number":"EMA/CHMP/443986/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-budesonide-formoterol-teva-pharma-bv_en.pdf"},
    {"id":"30510","name":"Gadolinium - Article 31 referral - Annex I, II, III, IV","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-09-01T02:00:00Z","last_updated_date":"2010-09-01T02:00:00Z","reference_number":"Doc. Ref. EMEA/727399/2009 Annex","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gadolinium-article-31-referral-annex-i-ii-iii-iv_sv.pdf"}},
    {"id":"30511","name":"Opinion of the HMPC on a community herbal monograph on Syzygium aromaticum (L.) Merill et L. M. Perry, floris aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T01:00:00Z","last_updated_date":"2011-12-21T01:00:00Z","reference_number":"EMA/HMPC/749910/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-syzygium-aromaticum-l-merill-et-l-m-perry-floris-aetheroleum_en.pdf"},
    {"id":"30512","name":"Management Board re-elects Vice-chair and starts budget discussions for 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-10T01:00:00Z","last_updated_date":"2009-03-10T01:00:00Z","reference_number":"EMEA/147842/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/management-board-re-elects-vice-chair-and-starts-budget-discussions-2010_en.pdf"},
    {"id":"30514","name":"Presentation - HEY YA! HEalth Literacy, Young Patients with Asthma and Adherence to Treatment (Erna Botjes, EFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hey-ya-health-literacy-young-patients-asthma-and-adherence-treatment-erna-botjes-efa_en.pdf"},
    {"id":"30517","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Concentrate of autologous bone marrow","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T13:30:00Z","last_updated_date":"2013-03-08T13:30:00Z","reference_number":"EMA/82120/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-concentrate-autologous-bone-marrow_en.pdf"},
    {"id":"30519","name":"Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord seeded on acellular amniotic matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T17:00:00Z","last_updated_date":"2016-04-12T17:00:00Z","reference_number":"EMA/240996/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-co-culture-keratinocytes-and-mesenchymal-stem-cells-isolated-umbilical-cord-seeded-acellular-amniotic-matrix_en.pdf-0"},
    {"id":"30520","name":"Withdrawal letter: Xgeva","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-xgeva_en.pdf"},
    {"id":"30521","name":"Presentation - A pharmacovigilance project in juvenile idiopathic arthritis (JIA) - Pharmachild the PRINTO perspective (Nicola Ruperto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-project-juvenile-idiopathic-arthritis-jia-pharmachild-printo-perspective-nicola-ruperto_en.pdf"},
    {"id":"30523","name":"Guido Rasi begins as new head of European Medicines Agency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-11-16T17:20:00Z","last_updated_date":"2011-11-16T17:20:00Z","reference_number":"EMA/901201/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/guido-rasi-begins-new-head-european-medicines-agency_en.pdf"},
    {"id":"30526","name":"Presentation - EORTC’s lessons learned for precision medicine in Europe: Opportunities for clinical research transformation - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCP...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eortcs-lessons-learned-precision-medicine-europe-opportunities-clinical-research-transformation-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcp_en.pdf"},
    {"id":"30529","name":"Declaration of interests: Kornelia Grein","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:11Z","last_updated_date":"2015-09-01T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-kornelia-grein_en.pdf"},
    {"id":"30530","name":"European Federation of Patients' Associations for Anthroposophic Medicine (EFPAM)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-federation-patients-associations-anthroposophic-medicine-efpam_en.pdf"},
    {"id":"30531","name":"Presentation - Implementation of the European Medicines Agency policy on the publication of clinical data: status report (Noel Wathion)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-european-medicines-agency-policy-publication-clinical-data-status-report-noel-wathion_en.pdf"},
    {"id":"30535","name":"Twenty-eighth meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-12-21T01:00:00Z","last_updated_date":"2000-12-21T01:00:00Z","reference_number":"EMEA/MB/056/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/twenty-eighth-meeting-management-board_en.pdf"},
    {"id":"30536","name":"EU/3/16/1744: Public summary of positive opinion for orphan designation of autologous mononuclear cells derived from human cord blood for the treatment of periventricular leukomalacia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/628394/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161744-public-summary-positive-opinion-orphan-designation-autologous-mononuclear-cells-derived-human-cord-blood-treatment-periventricular-leukomalacia_en.pdf"},
    {"id":"30537","name":"EU/3/10/776: Public summary of opinion on orphan designation: Autologous dendritic cells pulsed with recombinant human-fusion protein (mucin 1 − glutathione S transferase) coupled to oxidised polymannose for the treatm...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2013-10-17T17:00:00Z","reference_number":"EMA/COMP/400483/2010 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310776-public-summary-opinion-orphan-designation-autologous-dendritic-cells-pulsed-recombinant-human-fusion-protein-mucin-1-glutathione-s-transferase-coupled-oxidised-polymannose-treatm_en.pdf"},
    {"id":"30539","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-amsterdam_en.pdf-0"},
    {"id":"30541","name":"EU/3/05/303: Public summary of positive opinion for orphan designation ofhuman autologous mesenchymal adult stem cells extracted from adipose tissuefor the treatment of anal fistula","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2022-07-01T02:00:00Z","reference_number":"EMA/COMP/223443/2005 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305303-public-summary-positive-opinion-orphan-designation-ofhuman-autologous-mesenchymal-adult-stem-cells-extracted-adipose-tissuefor-treatment-anal-fistula_en.pdf"},
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    {"id":"30547","name":"Superseded Community herbal monograph on Cassia senna L, fructus and Cassia angustifolia Vahl, fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2006-10-26T02:09:00Z","last_updated_date":"2006-10-26T02:09:00Z","reference_number":"EMEA/HMPC/51871/2006 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-cassia-senna-l-fructus-and-cassia-angustifolia-vahl-fructus_en.pdf"},
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    {"id":"30555","name":"Questions and answers on the withdrawal of the marketing authorisation application for Faldaprevir Boehringer Ingelheim (faldaprevir)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/354906/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-faldaprevir-boehringer-ingelheim-faldaprevir_sv.pdf"}},
    {"id":"30556","name":"Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-09T19:00:00Z","last_updated_date":"2018-04-09T19:12:11Z","reference_number":"EMA/221190/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gastrointestinal-indication-list-nationally-authorised-medicinal-products-psusa00010291201706_en.pdf"},
    {"id":"30558","name":"FDA Practices - J. Sanit-Hugot","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-09-11T02:09:21Z","last_updated_date":"2006-09-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/fda-practices-j-sanit-hugot_en.pdf"},
    {"id":"30559","name":"EU/3/15/1500: Public summary of opinion on orphan designation: Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus for the treatment of hepatitis delta virus infection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"EMA/COMP/360280/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151500-public-summary-opinion-orphan-designation-synthetic-47-amino-acid-n-myristoylated-lipopeptide-derived-pres-region-hepatitis-b-virus-treatment-hepatitis-delta-virus-infection_en.pdf"},
    {"id":"30560","name":"Monthly Report - Pharmacovigilance Working Party (PhVWP) March 2010 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/173011/2010","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-march-2010-plenary-meeting_en.pdf"},
    {"id":"30564","name":"Committee for medicinal products for veterinary use (CVMP): Cox-2 inhibitors in veterinary medicine","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2006-12-13T12:09:21Z","last_updated_date":"2006-12-13T12:09:21Z","reference_number":"EMEA/CVMP/108858/2005-Rev.2","document_url":"https://www.ema.europa.eu/en/documents/public-statement/committee-medicinal-products-veterinary-use-cvmp-cox-2-inhibitors-veterinary-medicine_en.pdf"},
    {"id":"30565","name":"Twelfth pandemic pharmacovigilance weekly update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-02-24T01:00:00Z","last_updated_date":"2010-02-24T01:00:00Z","reference_number":"EMA/117826/2010","document_url":"https://www.ema.europa.eu/en/documents/report/twelfth-pandemic-pharmacovigilance-weekly-update_en.pdf"},
    {"id":"30566","name":"Presentation - Update on EMA Brexit preparedness (A. Humphreys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-17T16:27:00Z","last_updated_date":"2017-10-17T16:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ema-brexit-preparedness-humphreys_en.ppt"},
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    {"id":"30576","name":"Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004 on the potential risk for the consumer resulting from the use of diethanolamine as an excipient ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-07-25T12:27:00Z","last_updated_date":"2018-07-25T12:27:00Z","reference_number":"EMA/CVMP/473059/2018","document_url":"https://www.ema.europa.eu/en/documents/other/opinion-committee-medicinal-products-veterinary-use-pursuant-article-303-regulation-ec-no-7262004-potential-risk-consumer-resulting-use-diethanolamine-excipient_en.pdf"},
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    {"id":"30596","name":"CHMP summary of positive opinion for Ivabradine Anpharm","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/CHMP/461869/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ivabradine-anpharm_en.pdf"},
    {"id":"30598","name":"Agenda - FP7 and off patent medicines developed for children","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2007-06-06T02:09:21Z","last_updated_date":"2007-06-06T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fp7-and-patent-medicines-developed-children_en.pdf"},
    {"id":"30600","name":"Human Centralised Procedure, G Wade, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/human-centralised-procedure-g-wade-ema_en.pdf"},
    {"id":"30603","name":"EU/3/12/967: Public summary of opinion on orphan designation: Sodium nitrite for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T18:00:00Z","last_updated_date":"2012-07-06T18:00:00Z","reference_number":"EMA/COMP/68665/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312967-public-summary-opinion-orphan-designation-sodium-nitrite-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"30604","name":"Questions and answers on recommendation for refusal of marketing authorisation  for  Valdoxan/Thymanax","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2006-07-27T02:09:21Z","last_updated_date":"2006-07-27T02:09:21Z","reference_number":"EMEA/267703/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-valdoxanthymanax_en.pdf"},
    {"id":"30607","name":"Report from the EMA-FDA QbD pilot program","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-04-19T18:00:00Z","last_updated_date":"2017-04-19T18:00:00Z","reference_number":"EMA/213746/2017","document_url":"https://www.ema.europa.eu/en/documents/other/report-ema-fda-qbd-pilot-program_en.pdf"},
    {"id":"30608","name":"Final Community herbal monograph on Arnica montana L., flos","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/HMPC/198793/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-arnica-montana-l-flos_en.pdf"},
    {"id":"30610","name":"Conventional medicinal products: Responses to list of questions / Supplementary Request of information / List of outstanding issues","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-25T01:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/conventional-medicinal-products-responses-list-questions-supplementary-request-information-list-outstanding-issues_en.pdf"},
    {"id":"30611","name":"European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2015","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2016-06-21T18:00:00Z","last_updated_date":"2016-06-21T18:00:00Z","reference_number":"EMA/727872/2015","document_url":"https://www.ema.europa.eu/en/documents/annual-report/european-medicines-agencys-interaction-patients-consumers-healthcare-professionals-and-their-organisations-annual-report-2015_en.pdf"},
    {"id":"30612","name":"CVMP summary of opinion for Zolvix","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-07-17T03:09:00Z","last_updated_date":"2009-07-17T03:09:00Z","reference_number":"EMEA/CVMP/398294/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-opinion-zolvix_en.pdf"},
    {"id":"30613","name":"Human medicines highlights - July 2014","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-08-07T18:00:00Z","last_updated_date":"2014-08-07T18:00:00Z","reference_number":"Issue 65","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-july-2014_en.pdf"},
    {"id":"30616","name":"Committee on herbal medicinal products: Elects new chair and vice-chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/509881/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-herbal-medicinal-products-elects-new-chair-and-vice-chair_en.pdf"},
    {"id":"30622","name":"Guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-10-18T02:00:00Z","last_updated_date":"2006-10-18T02:00:00Z","reference_number":"CPMP/EWP/422/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis-first-version_en.pdf"},
    {"id":"30624","name":"Public summary of the evaluation of a proposed product-specific\n\nwaiver: Calcium (carbonate) / cholecalciferol (in combination with ibandronic acid) for combination treatment of osteoporosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T12:30:00Z","last_updated_date":"2015-02-23T12:30:00Z","reference_number":"EMA/69568/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-calcium-carbonate-cholecalciferol-combination-ibandronic-acid-combination-treatment-osteoporosis_en.pdf"},
    {"id":"30626","name":"Anastrozole: List of nationally authorised medicinal products - PSUSA/00000210/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T13:30:00Z","last_updated_date":"2018-04-13T14:00:56Z","reference_number":"EMA/223603/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/anastrozole-list-nationally-authorised-medicinal-products-psusa00000210201708_en.pdf"},
    {"id":"30627","name":"EU/3/12/1068: Public summary of opinion on orphan designation: Melarsoprol for treatment of African trypanosomiasis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2012-12-12T01:00:00Z","reference_number":"EMA/COMP/684363/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121068-public-summary-opinion-orphan-designation-melarsoprol-treatment-african-trypanosomiasis_en.pdf"},
    {"id":"30628","name":"VICH GL19: Efficacy of anthelmintics - Specific recommendations for canines - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-07-30T02:00:00Z","last_updated_date":"2001-07-30T02:00:00Z","reference_number":"CVMP/VICH/835/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl19-efficacy-anthelmintics-specific-recommendations-canines-step-7_en.pdf"},
    {"id":"30629","name":"EU/3/15/1574: Public summary of opinion on orphan designation: 4’-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2’-(ethoxymethyl)-[1,1’-biphenyl]-2-sulfonamide for the treatment o...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/COMP/696157/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151574-public-summary-opinion-orphan-designation-4-2-butyl-4-oxo-13-diazaspiro44non-1-en-3-ylmethyl-n-45-dimethyl-3-isoxazolyl-2-ethoxymethyl-11-biphenyl-2-sulfonamide-treatment-o_en.pdf"},
    {"id":"30630","name":"Opinion of the HMPC on a Community herbal monograph on Plantago afra L. et Plantago indica L., semen","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-07-29T15:30:00Z","last_updated_date":"2013-07-29T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-plantago-afra-l-et-plantago-indica-l-semen_en.pdf"},
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    {"id":"30638","name":"EPARs survey - Similarities and divergences between Europe and USA - Solange Corriol-Rohou","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/epars-survey-similarities-and-divergences-between-europe-and-usa-solange-corriol-rohou_en.pdf"},
    {"id":"30640","name":"CHMP positive summary of opinion for Bretaris Genuair","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-06-28T02:00:00Z","reference_number":"EMA/CHMP/304281/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-bretaris-genuair_en.pdf"},
    {"id":"30641","name":"CHMP summary of opinion for Airexar Spiromax","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/431246/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-airexar-spiromax_en.pdf"},
    {"id":"30642","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Cerdelga (eliglustat) for the treatment of Gaucher disease","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T15:20:00Z","last_updated_date":"2015-02-17T15:20:00Z","reference_number":"EMA/COMP/748368/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-cerdelga-eliglustat-treatment-gaucher-disease_en.pdf"},
    {"id":"30643","name":"CHMP summary of positive opinion for Vpriv","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2010-06-25T02:00:00Z","reference_number":"EMA/CHMP/384050/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vpriv_en.pdf"},
    {"id":"30644","name":"Cardioxane Article 13 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-26T11:42:00Z","last_updated_date":"2017-07-26T11:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cardioxane-article-13-referral-chmp-assessment-report_en.pdf"},
    {"id":"30649","name":"Modified-release oral opioids - Article 31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/modified-release-oral-opioids-article-31-referral-annex-iii_no.pdf"}},
    {"id":"30651","name":"Call for submission of scientific data relating to the assessment of Chamomillae romanae flos chamaemelum nobile (l.) all. (anthemis nobilis l.), flos (chamomile flower, roman)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-10-15T02:09:21Z","last_updated_date":"2009-10-15T02:09:21Z","reference_number":"EMEA/HMPC/604441/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-chamomillae-romanae-flos-chamaemelum-nobile-l-all-anthemis-nobilis-l-flos-chamomile-flower-roman_en.pdf"},
    {"id":"30652","name":"Opinion following an Article 34 referral for Synulox Lactating Cow and associated names: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-11-17T12:00:00Z","last_updated_date":"2011-11-17T12:00:00Z","reference_number":"EMA/512798/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-34-referral-synulox-lactating-cow-and-associated-names-background-information_sv.pdf"}},
    {"id":"30653","name":"Ex ante publicity of a negotiated procedure: EMA/2016/13/FI - Physical inventory of fixed assets","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-05-03T12:45:00Z","last_updated_date":"2016-05-03T12:45:00Z","reference_number":"EMA/220134/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201613fi-physical-inventory-fixed-assets_en.pdf"},
    {"id":"30655","name":"Draft assessment report on Vaccinium myrtillus L., fructus recens","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-02-09T01:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/HMPC/555161/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-vaccinium-myrtillus-l-fructus-recens_en.pdf"},
    {"id":"30657","name":"Overview of comments received on draft guideline on data requirements for IVMPS intended for minor use or minor species/limited markets - Revision 2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-07-12T02:00:00Z","last_updated_date":"2007-07-12T02:00:00Z","reference_number":"EMEA/CVMP/IWP/279839/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-data-requirements-ivmps-intended-minor-use-or-minor-specieslimited-markets-revision-2_en.pdf"},
    {"id":"30658","name":"Presentation - EMA report to the European Commission – Article 50","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-report-european-commission-article-50_en.pdf"},
    {"id":"30659","name":"Presentation - European Commission Directorate Health and Food Safety Health Systems and Products: medicinal products - quality, safety and efficacy (Agnieszka Kasperek)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-commission-directorate-health-and-food-safety-health-systems-and-products-medicinal-products-quality-safety-and-efficacy-agnieszka-kasperek_en.pdf"},
    {"id":"30662","name":"CHMP summary of positive opinion for Symkevi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"EMA/CHMP/413708/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-symkevi_en.pdf"},
    {"id":"30663","name":"EU/3/04/224: Public summary of positive opinion for orphan designation of\n\nhomoharringtonine for treatment of chronic myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2016-08-10T02:00:00Z","reference_number":"EMA/COMP/44012/2004 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304224-public-summary-positive-opinion-orphan-designation-homoharringtonine-treatment-chronic-myeloid-leukaemia_en.pdf"},
    {"id":"30668","name":"Presentation - How can patients and caregivers contribute to generate data on behavioural changes? (Elisa Ferrer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-can-patients-and-caregivers-contribute-generate-data-behavioural-changes-elisa-ferrer_en.pdf"},
    {"id":"30669","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - PRAC recommendations on Diane 35: Questions and answers","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T14:00:00Z","last_updated_date":"2013-05-17T14:00:00Z","reference_number":"EMA/280182/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-prac-recommendations-diane-35-questions-and-answers_en.pdf"},
    {"id":"30670","name":"Presentation - Moving away from traditional networks towards interactive dataset sharing (Dominique Haumont)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-moving-away-traditional-networks-towards-interactive-dataset-sharing-dominique-haumont_en.pdf"},
    {"id":"30671","name":"NorPEN The Nordic Pharmacoepidemiological Network for knowledge exchange, research and research training - H. Kieler","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/norpen-nordic-pharmacoepidemiological-network-knowledge-exchange-research-and-research-training-h-kieler_en.pdf"},
    {"id":"30675","name":"Presentation - Post-authorisation safety studies – PRAC experience (Almath Spooner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-post-authorisation-safety-studies-prac-experience-almath-spooner_en.pdf"},
    {"id":"30679","name":"Information for women using oral contraceptives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2001-09-28T02:00:00Z","last_updated_date":"2001-09-28T02:00:00Z","reference_number":"EMEA/CPMP/2259/01/en/Final","document_url":"https://www.ema.europa.eu/en/documents/other/information-women-using-oral-contraceptives_en.pdf"},
    {"id":"30680","name":"Overview of comments received on 'Paracetamol oral use, immediate release formulations product-specific bioequivalence guidance' (EMA/CHMP/356877/2017) - First version","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2018-02-01T13:00:00Z","last_updated_date":"2018-02-01T13:00:00Z","reference_number":"EMA/CHMP/729976/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-paracetamol-oral-use-immediate-release-formulations-product-specific-bioequivalence-guidance-emachmp3568772017-first-version_en.pdf"},
    {"id":"30681","name":"Methadone Article-107i procedure - Rationale for triggering","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methadone-article-107i-procedure-rationale-triggering_en.pdf"},
    {"id":"30683","name":"Work instructions for good-manufacturing-practice validation of initial marketing-authorisation applications, line extensions and variations","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T11:40:00Z","last_updated_date":"2013-04-30T11:40:00Z","reference_number":"WIN/INS/2041","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-good-manufacturing-practice-validation-initial-marketing-authorisation-applications-line-extensions-and-variations_en.pdf"},
    {"id":"30684","name":"Superseded overview of comments received on Community herbal monograph on plantago ovata Forssk., semen (EMEA/HMPC/340861/2005)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/65636/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-plantago-ovata-forssk-semen-emeahmpc3408612005_en.pdf"},
    {"id":"30686","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12–15 September 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-10-16T11:16:00Z","last_updated_date":"2017-10-16T11:16:00Z","reference_number":"EMEA/PDCO/644202/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-15-september-2017_en.pdf"},
    {"id":"30688","name":"Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-09-17T18:28:00Z","last_updated_date":"2015-09-17T18:28:00Z","reference_number":"EMA/CVMP/IWP/37620/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-replacement-cell-lines-used-production-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"30689","name":"CHMP post-authorisation summary of positive opinion for Intelence","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"EMA/CHMP/723089/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-intelence_en.pdf"},
    {"id":"30691","name":"Request for the CVMP to classify a veterinary medicinal product as intended for use in minor uses minor species / limited market","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-07-24T02:09:21Z","last_updated_date":"2013-08-02T16:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-cvmp-classify-veterinary-medicinal-product-intended-use-minor-uses-minor-species-limited-market_en.pdf"},
    {"id":"30692","name":"Presentation - Considerations in the development of beta-lactamase inhibitor combination products for multiple drug resistant (MDR) pathogens (Michael Dudley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-considerations-development-beta-lactamase-inhibitor-combination-products-multiple-drug-resistant-mdr-pathogens-michael-dudley_en.pdf"},
    {"id":"30693","name":"Pentamidine: List of nationally authorised medicinal products - PSUSA/00002338/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T15:15:00Z","last_updated_date":"2018-02-13T15:15:00Z","reference_number":"EMA/94268/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/pentamidine-list-nationally-authorised-medicinal-products-psusa00002338201706_en.pdf"},
    {"id":"30694","name":"Sevoflurane: List of nationally authorised medicinal products - PSUSA/00002698/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-14T12:00:00Z","last_updated_date":"2016-10-18T11:56:09Z","reference_number":"EMA/642675/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/sevoflurane-list-nationally-authorised-medicinal-products-psusa00002698201501_en.pdf"},
    {"id":"30695","name":"Guidance on format of the risk-management plan in the European Union part IV: Plans for postauthorisation efficacy studies","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2012-11-14T01:00:00Z","reference_number":"EMA/712370/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-iv-plans-postauthorisation-efficacy-studies_en.doc"},
    {"id":"30697","name":"Product information templates  - human medicinal products","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-28T02:00:00Z","last_updated_date":"2005-07-28T02:00:00Z","reference_number":"EMEA/245309/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/product-information-templates-human-medicinal-products_en.pdf"},
    {"id":"30699","name":"Presentation -  Adaptive pathways workshop (Alison Cave)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adaptive-pathways-workshop-alison-cave_en.pdf"},
    {"id":"30701","name":"CHMP summary of positive opinion for Desloratadine Actavis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T01:00:00Z","last_updated_date":"2011-11-18T01:00:00Z","reference_number":"EMA/CHMP/796881/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-desloratadine-actavis_en.pdf"},
    {"id":"30704","name":"Calcium Sandoz - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2005-08-10T01:59:00Z","last_updated_date":"2005-08-10T01:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/calcium-sandoz-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"30707","name":"Public statement on Opgenra: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-07-14T17:00:00Z","last_updated_date":"2016-07-14T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-opgenra-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"30708","name":"EU/3/09/705: Public summary of opinion on orphan designation of human monoclonal antibody against Pseudomonas aeruginosa IATS-O1 for the treatment of pneumonia caused by serotype O1 Pseudomonas aeruginosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2021-02-03T01:00:00Z","reference_number":"EMA/768546/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309705-public-summary-opinion-orphan-designation-human-monoclonal-antibody-against-pseudomonas-aeruginosa-iats-o1-treatment-pneumonia-caused-serotype-o1-pseudomonas-aeruginosa_en.pdf"},
    {"id":"30710","name":"EU/3/05/278: Public summary of positive opinion for orphan designation of 3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-04T02:00:00Z","last_updated_date":"2015-03-10T13:00:00Z","reference_number":"EMEA/COMP/122996/2005 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305278-public-summary-positive-opinion-orphan-designation-3-5-2-fluoro-phenyl-124oxadiazole-3-yl-benzoic-acid-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"30711","name":"Pilocarpine (non ophthalmic formulations): List of nationally authorised medicinal products - PSUSA/00002409/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-16T12:48:00Z","last_updated_date":"2018-04-16T12:52:00Z","reference_number":"EMA/235877/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/pilocarpine-non-ophthalmic-formulations-list-nationally-authorised-medicinal-products-psusa00002409201707_en.pdf"},
    {"id":"30713","name":"Public statement on Ablavar: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2011-11-14T11:40:00Z","last_updated_date":"2011-11-14T11:40:00Z","reference_number":"EMA/854517/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ablavar-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"30714","name":"Kosovo - Food and Veterinary Agency, K Uka","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/kosovo-food-and-veterinary-agency-k-uka_en.pdf"},
    {"id":"30715","name":"Presentation - Healthcare Professionals' Working Party (HCPWP): Nomination of observers (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T17:00:00Z","last_updated_date":"2013-07-12T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthcare-professionals-working-party-hcpwp-nomination-observers-ivana-silva_en.pdf"},
    {"id":"30716","name":"Presentation - Agenda point 3: ESVAC Report 2015 - Interactive database (Kristine Ignate)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-point-3-esvac-report-2015-interactive-database-kristine-ignate_en.pdf"},
    {"id":"30718","name":"Agenda - Visit of GIRP - European Association of Pharmaceutical Full-line Wholesalers","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-10-06T02:00:00Z","reference_number":"EMA/338607/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-visit-girp-european-association-pharmaceutical-full-line-wholesalers_en.pdf"},
    {"id":"30721","name":"Agenda and registration form - First information day on the use of the Medical Dictionary for Regulatory Activities (MedDRA) including medication errors","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-08-21T02:00:00Z","last_updated_date":"2013-09-19T12:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-first-information-day-use-medical-dictionary-regulatory-activities-meddra-including-medication-errors_en.pdf"},
    {"id":"30722","name":"EMEA-EFPIA 'Quality by Design' application workshop - Introduction","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-09-28T02:09:21Z","last_updated_date":"2009-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-efpia-quality-design-application-workshop-introduction_en.pdf"},
    {"id":"30723","name":"Presentation - Welcome to NETSTAP","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T16:02:00Z","last_updated_date":"2018-06-18T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-welcome-netstap_en.pdf"},
    {"id":"30728","name":"Thirty-first meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-10-10T02:09:21Z","last_updated_date":"2001-10-10T02:09:21Z","reference_number":"EMEA/MB/044/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/thirty-first-meeting-management-board_en.pdf"},
    {"id":"30729","name":"EU/3/17/1916: Public summary of opinion on orphan designation: 5-amino-1-(2-methyl-1H-benzo[d]imidazol-5-yl)-1H-pyrazol-4-yl 1H-indol-2-yl ketone mono[(S)-2-hydroxysuccinate] for the treatment of biliary tract cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-10T10:25:00Z","last_updated_date":"2018-01-10T10:25:00Z","reference_number":"EMA/620630/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171916-public-summary-opinion-orphan-designation-5-amino-1-2-methyl-1h-benzodimidazol-5-yl-1h-pyrazol-4-yl-1h-indol-2-yl-ketone-monos-2-hydroxysuccinate-treatment-biliary-tract-cancer_en.pdf"},
    {"id":"30730","name":"CHMP summary of positive opinion for Evotaz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/277547/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-evotaz_en.pdf"},
    {"id":"30733","name":"Technical Specifications - Annex VII-A Substances and related substance groups: Procurement procedure EMA/2014/01/PH","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-vii-substances-and-related-substance-groups-procurement-procedure-ema201401ph_en.pdf"},
    {"id":"30735","name":"Ezetimibe: List of nationally authorised medicinal products - PSUSA/00001346/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-22T17:00:00Z","last_updated_date":"2018-06-22T17:00:00Z","reference_number":"EMA/417291/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ezetimibe-list-nationally-authorised-medicinal-products-psusa00001346201710_en.pdf"},
    {"id":"30737","name":"Agenda - Training session for patients and consumers interested in EMA activities","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-12-20T16:30:00Z","reference_number":"EMA/636824/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-patients-and-consumers-interested-ema-activities_en.pdf"},
    {"id":"30739","name":"CVMP summary of positive opinion for Eryseng","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/CVMP/158588/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-eryseng_en.pdf"},
    {"id":"30740","name":"National Experience on collection and analysis of data on AM sales and use - Gà©rard Moulin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/national-experience-collection-and-analysis-data-am-sales-and-use-gacrard-moulin_en.pdf"},
    {"id":"30741","name":"Presentation - Session 3.1: Updates on networks - Spanish network (Cristina Serà©n Trasorras)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-31-updates-networks-spanish-network-cristina-seracn-trasorras_en.pdf"},
    {"id":"30743","name":"Final list of references supporting the assessment of Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-02-07T01:00:00Z","last_updated_date":"2012-02-07T01:00:00Z","reference_number":"EMA/HMPC/722366/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-cola-nitida-vent-schott-et-endl-and-its-varieties-and-cola-acuminata-p-beauv-schott-et-endl-semen_en.pdf"},
    {"id":"30744","name":"CHMP summary of positive opinion for Pantoloc Control","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2022-01-18T01:00:00Z","reference_number":"EMEA/CHMP/108579/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pantoloc-control_en.pdf"},
    {"id":"30746","name":"Menthae arvensis aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-05-01T02:00:00Z","last_updated_date":"2001-05-01T02:00:00Z","reference_number":"EMEA/MRL/787/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/menthae-arvensis-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30747","name":"Public statement on Vitekta: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-vitekta-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"30749","name":"Presentation - Discussion 'progress for the benefit of public health', Ralf Gold","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-discussion-progress-benefit-public-health-ralf-gold_en.pdf"},
    {"id":"30751","name":"Pharmacovigilance fees: questions and answers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T14:00:00Z","last_updated_date":"2021-01-06T10:55:00Z","reference_number":"EMA/175299/2015 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/other/pharmacovigilance-fees-questions-and-answers_en.pdf"},
    {"id":"30752","name":"Bituminosulfonates, ammonium and sodium salts: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-02-01T01:00:00Z","last_updated_date":"1999-02-01T01:00:00Z","reference_number":"EMEA/MRL/511/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bituminosulfonates-ammonium-and-sodium-salts-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30753","name":"Presentation - Session 1: List of Questions from Participants on non-clinical development of ATMPs","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T12:00:00Z","last_updated_date":"2012-02-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-list-questions-participants-non-clinical-development-atmps_en.pdf"},
    {"id":"30754","name":"Presentation - GVP Module VI – ADR, pharmacovigilance guideline for paediatric medicines (Roberto De Lisa and Priya Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-25T16:03:00Z","last_updated_date":"2017-07-25T16:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gvp-module-vi-adr-pharmacovigilance-guideline-paediatric-medicines-roberto-de-lisa-and-priya-bahri_en.pdf"},
    {"id":"30755","name":"Alprostadil (patency of the ductus arteriosus): List of nationally authorised medicinal products - PSUSA/00010021/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2016-10-17T19:40:17Z","reference_number":"EMA/246277/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/alprostadil-patency-ductus-arteriosus-list-nationally-authorised-medicinal-products-psusa00010021201507_en.pdf"},
    {"id":"30757","name":"Baxter dialysis solutions Article-31 referral - Annex II (3 sites)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-ii-3-sites_sv.pdf"}},
    {"id":"30759","name":"Call for submission of scientific data relating to the assessment of Cichorii intybi planta tota; Cichorium intybus l., planta tota (chicory whole plant) Cichorii intybi folium; Cichorium intybus l., folium (chicory leaf...","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-02-15T00:09:21Z","last_updated_date":"2009-02-15T00:09:21Z","reference_number":"EMEA/HMPC/74358/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-cichorii-intybi-planta-tota-cichorium-intybus-l-planta-tota-chicory-whole-plant-cichorii-intybi-folium-cichorium-intybus-l-folium-chicory-leaf_en.pdf"},
    {"id":"30761","name":"Presentation - Pharmacovigilance and product data (Jos Olaerts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-27T02:00:00Z","last_updated_date":"2017-03-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-and-product-data-jos-olaerts_en.pdf"},
    {"id":"30763","name":"Agenda - Paediatric anticoagulation therapy expert meeting 6 November 2012","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-07-08T19:00:00Z","last_updated_date":"2013-07-08T19:00:00Z","reference_number":"EMA/673870/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-paediatric-anticoagulation-therapy-expert-meeting-6-november-2012_en.pdf"},
    {"id":"30764","name":"Public statement on Exalief: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-08-07T12:50:00Z","last_updated_date":"2012-08-07T12:50:00Z","reference_number":"EMA/507881/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-exalief-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"30765","name":"EU/3/06/414: Public summary of positive opinion for orphan designation of catumaxomab for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T00:00:00Z","last_updated_date":"2014-02-08T00:00:00Z","reference_number":"EMEA/COMP/188397/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306414-public-summary-positive-opinion-orphan-designation-catumaxomab-treatment-gastric-cancer_en.pdf"},
    {"id":"30766","name":"Programme - European Medicines Agency workshop on the development of new medicinal products for the treatment of ulcerative colitis and Crohn’s disease","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/292143/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-european-medicines-agency-workshop-development-new-medicinal-products-treatment-ulcerative-colitis-and-crohns-disease_en.pdf"},
    {"id":"30768","name":"CVMP monthly report of application procedures, guidelines and related documents: June 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-07-09T11:50:00Z","last_updated_date":"2013-07-09T11:50:00Z","reference_number":"EMA/249895/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-june-2013_en.pdf"},
    {"id":"30769","name":"Presentation - Modelling and simulation to optimise the design of confirmatory trials, to analyse phase 3 data and to characterise risk-benefit and support label claims - Break-out session 4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T13:15:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-optimise-design-confirmatory-trials-analyse-phase-3-data-and-characterise-risk-benefit-and-support-label-claims-break-out-session-4_en.pdf"},
    {"id":"30770","name":"All submissions combined","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-03T02:09:21Z","last_updated_date":"2007-10-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/all-submissions-combined_en.pdf"},
    {"id":"30774","name":"Presentation - When is it appropriate to combine phases","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-when-it-appropriate-combine-phases_en.pdf"},
    {"id":"30775","name":"User guide on how to generate PDF versions of the product information - veterinary","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2023-05-12T15:42:00Z","reference_number":"EMA/793983/2010 v.4.01","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/user-guide-how-generate-pdf-versions-product-information-veterinary_en.pdf"},
    {"id":"30776","name":"EU/3/16/1637: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA and covalently linked to a ligand containing three N-acetylgalact...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2016-05-02T02:00:00Z","reference_number":"EMA/COMP/172901/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161637-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-hydroxyacid-oxidase-1-mrna-and-covalently-linked-ligand-containing-three-n_en.pdf"},
    {"id":"30779","name":"Meeting highlights from the Paediatric Committee: 10 - 12 December 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-12-17T01:00:00Z","last_updated_date":"2008-12-17T01:00:00Z","reference_number":"EMEA/PDCO/675823/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-10-12-december-2008_en.pdf"},
    {"id":"30780","name":"Opinion of the HMPC on a European Union herbal monograph on Sisymbrium officinale (L.) Scop., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-10-30T01:00:00Z","last_updated_date":"2014-10-30T01:00:00Z","reference_number":"EMA/HMPC/600047/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"30782","name":"Agenda - Workshop on antibacterials","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-02-04T00:31:00Z","last_updated_date":"2011-02-04T00:31:00Z","reference_number":"EMA/90390/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-antibacterials_en.pdf"},
    {"id":"30785","name":"The Concerns of the Homeopathy Profession in Relation to Homeopathic Medicines in Europe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/concerns-homeopathy-profession-relation-homeopathic-medicines-europe_en.pdf"},
    {"id":"30788","name":"Overview of Comments received on Public Statement on the allergenic potency of herbal medicinal products containing soya or peanut protein","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-01-12T01:00:00Z","last_updated_date":"2006-01-12T01:00:00Z","reference_number":"EMEA/381405/2005","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-public-statement-allergenic-potency-herbal-medicinal-products-containing-soya-or-peanut-protein_en.pdf"},
    {"id":"30790","name":"Legal advice in relation to Dutch employment and labour law","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T11:35:00Z","last_updated_date":"2018-06-01T11:35:00Z","reference_number":"EMA/281766/2018","document_url":"https://www.ema.europa.eu/en/documents/procurement/legal-advice-relation-dutch-employment-and-labour-law_en.pdf"},
    {"id":"30791","name":"Presentation - Best expertise vs conflicts of interests: Striking the right balance (Martin Pigeon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-best-expertise-vs-conflicts-interests-striking-right-balance-martin-pigeon_en.pdf"},
    {"id":"30793","name":"Presentation - Natalizumab (Tysabri) and PML - the current figures, Brigitte Keller-Stanislawski","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-natalizumab-tysabri-and-pml-current-figures-brigitte-keller-stanislawski_en.pdf"},
    {"id":"30796","name":"EU/3/15/1531: Public summary of opinion on orphan designation: Sarizotan hydrochloride for the treatment of Rett syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T02:00:00Z","last_updated_date":"2015-08-18T02:00:00Z","reference_number":"EMA/COMP/430803/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151531-public-summary-opinion-orphan-designation-sarizotan-hydrochloride-treatment-rett-syndrome_en.pdf"},
    {"id":"30798","name":"EU/3/08/607: Public summary of positive opinion for orphan designation of type I native bovine skin collagen for treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/541000/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308607-public-summary-positive-opinion-orphan-designation-type-i-native-bovine-skin-collagen-treatment-systemic-sclerosis_en.pdf"},
    {"id":"30799","name":"Committee for Medicinal Products for Veterinary Use (CVMP) monthly report of application procedures, guidelines and related documents: May 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T14:30:00Z","last_updated_date":"2012-05-30T14:30:00Z","reference_number":"EMA/343346/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-may-2012_en.pdf"},
    {"id":"30800","name":"CVMP post-authorisation summary of opinion for Advocate","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-04-20T03:09:21Z","last_updated_date":"2009-04-20T03:09:21Z","reference_number":"EMEA/CVMP/205582/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-opinion-advocate_en.pdf"},
    {"id":"30801","name":"EMA recommends avoidance of certain hepatitis C medicines and amiodarone together","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/258577/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-avoidance-certain-hepatitis-c-medicines-and-amiodarone-together_en.pdf"},
    {"id":"30803","name":"Final Community herbal monograph on Plantago ovata Forssk., semen","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T15:30:00Z","last_updated_date":"2013-07-23T15:30:00Z","reference_number":"EMA/HMPC/304390/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-plantago-ovata-forssk-semen_en.pdf"},
    {"id":"30804","name":"Guidance on documentation to be provided by member states and applicants/MAHS in support of a simplified registration referral under articles 16c(1)c and 16c(4)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-09-07T02:00:00Z","last_updated_date":"2006-09-07T02:00:00Z","reference_number":"EMEA/HMPC/431129/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-documentation-be-provided-member-states-and-applicantsmahs-support-simplified-registration-referral-under-articles-16c1c-and-16c4_en.pdf"},
    {"id":"30805","name":"Presentation - General concepts on process validation (Kowid Ho)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-general-concepts-process-validation-kowid-ho_en.pdf"},
    {"id":"30807","name":"Standalone signal notification form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T11:55:00Z","last_updated_date":"2020-02-27T10:01:00Z","reference_number":"EMA/150823/2017 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/template-form/standalone-signal-notification-form_en.doc"},
    {"id":"30808","name":"CHMP summary of opinion for Empliciti","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-01-29T01:00:00Z","reference_number":"EMA/CHMP/15592/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-empliciti_en.pdf"},
    {"id":"30809","name":"EU/3/14/1420: Public summary of opinion on orphan designation: Emtricitabine for the treatment of Aicardi-Goutià¨res syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T12:00:00Z","last_updated_date":"2015-03-06T12:00:00Z","reference_number":"EMA/COMP/797337/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141420-public-summary-opinion-orphan-designation-emtricitabine-treatment-aicardi-goutiares-syndrome_en.pdf"},
    {"id":"30810","name":"Year 2005-2006 - Module on drug evaluation in children - Objectives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-09-19T02:09:21Z","last_updated_date":"2005-09-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/year-2005-2006-module-drug-evaluation-children-objectives_en.pdf"},
    {"id":"30811","name":"Trimetazidine - Article 31 - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-17T02:00:00Z","last_updated_date":"2012-10-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/trimetazidine-article-31-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/trimetazidine-article-31-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/trimetazidine-article-31-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/trimetazidine-article-31-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/trimetazidine-article-31-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/trimetazidine-article-31-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/trimetazidine-article-31-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/trimetazidine-article-31-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/trimetazidine-article-31-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/trimetazidine-article-31-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/trimetazidine-article-31-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/trimetazidine-article-31-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/trimetazidine-article-31-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/trimetazidine-article-31-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/trimetazidine-article-31-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/trimetazidine-article-31-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/trimetazidine-article-31-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/trimetazidine-article-31-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/trimetazidine-article-31-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/trimetazidine-article-31-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/trimetazidine-article-31-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/trimetazidine-article-31-annex-i_sv.pdf"}},
    {"id":"30813","name":"Lubiprostone : List of nationally authorised medicinal products -  PSUSA/00010290/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T12:12:00Z","last_updated_date":"2017-09-06T12:13:41Z","reference_number":"EMA/583969/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/lubiprostone-list-nationally-authorised-medicinal-products-psusa00010290201701_en.pdf"},
    {"id":"30814","name":"Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-01-22T01:00:00Z","last_updated_date":"2022-09-28T00:00:00Z","reference_number":"EMA/305821/2006 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/checking-process-mock-ups-and-specimens-outer-immediate-labelling-and-package-leaflets-human-medicinal-products-centralised-procedure_en.pdf"},
    {"id":"30815","name":"EU/3/15/1503: Public summary of opinion on orphan designation: Allogeneic ex-vivo-expanded human umbilical cord blood-derived mesenchymal stem cells for the prevention of bronchopulmonary dysplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"EMA/COMP/359112/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151503-public-summary-opinion-orphan-designation-allogeneic-ex-vivo-expanded-human-umbilical-cord-blood-derived-mesenchymal-stem-cells-prevention-bronchopulmonary-dysplasia_en.pdf"},
    {"id":"30817","name":"European Medicines Agency recommends approval of medicine for treatment of vitreomacular traction","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-01-18T01:00:00Z","reference_number":"EMA/CHMP/25557/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-medicine-treatment-vitreomacular-traction_en.pdf"},
    {"id":"30819","name":"Propylene glycol used as an excipient - Report published in support of the ‘Questions and answers on propylene glycol used as an excipient in medicinal products for human use’","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/334655/2013","document_url":"https://www.ema.europa.eu/en/documents/report/propylene-glycol-used-excipient-report-published-support-questions-and-answers-propylene-glycol-used-excipient-medicinal-products-human-use_en.pdf"},
    {"id":"30820","name":"PDCO meeting highlights 27-29 May 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-06-03T02:00:00Z","last_updated_date":"2009-06-03T02:00:00Z","reference_number":"EMEA/PDCO/298970/2009- Rev1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-27-29-may-2009_en.pdf"},
    {"id":"30822","name":"Agenda - CAT agenda of the 12-13 November 2015 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-11-16T10:20:00Z","last_updated_date":"2015-11-16T10:20:00Z","reference_number":"EMA/CAT/716666/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-12-13-november-2015-meeting_en.pdf"},
    {"id":"30823","name":"Presentation - Electronic submission of information on medicinal products in accordance to Article 57(2) requirements: Maintenance submission (Ilaria Del Seppia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronic-submission-information-medicinal-products-accordance-article-572-requirements-maintenance-submission-ilaria-del-seppia_en.pdf"},
    {"id":"30828","name":"Seroquel, Seroquel XR and associated names Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-09T02:00:00Z","last_updated_date":"2014-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/seroquel-seroquel-xr-and-associated-names-article-30-referral-annex-i_no.pdf"}},
    {"id":"30829","name":"Narcolepsy treatment recommended for approval","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"EMA/CHMP/764032/2015 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/narcolepsy-treatment-recommended-approval_en.pdf"},
    {"id":"30830","name":"List of participants - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-joint-biologics-working-party-quality-working-party-workshop-stakeholders-relation-prior-knowledge-and-its-use-regulatory-applications_en.pdf"},
    {"id":"30833","name":"EU/3/14/1315: Public summary of opinion on orphan designation: Recombinant human apolipoprotein A-I in a complex with phospholipids for the treatment of apolipoprotein A-I deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2014-10-01T02:00:00Z","reference_number":"EMA/COMP/434437/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141315-public-summary-opinion-orphan-designation-recombinant-human-apolipoprotein-i-complex-phospholipids-treatment-apolipoprotein-i-deficiency_en.pdf"},
    {"id":"30834","name":"EU/3/07/457: Public summary of positive opinion for orphan designation of lusupultide for the treatment of aspiration pneumonitis requiring intubation and mechanical ventilation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/241008/2007 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307457-public-summary-positive-opinion-orphan-designation-lusupultide-treatment-aspiration-pneumonitis-requiring-intubation-and-mechanical-ventilation_en.pdf"},
    {"id":"30835","name":"European Union backwards forwards conversion element mapping spreadsheet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-27T01:00:00Z","last_updated_date":"2015-10-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-backwards-forwards-conversion-element-mapping-spreadsheet_en.xlsx"},
    {"id":"30836","name":"Summary report on the EMA workshop on stem cellbased therapies","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-07-01T02:00:00Z","last_updated_date":"2010-07-01T02:00:00Z","reference_number":"EMA/319294/2010","document_url":"https://www.ema.europa.eu/en/documents/report/summary-report-ema-workshop-stem-cellbased-therapies_en.pdf"},
    {"id":"30838","name":"List of participants - First stakeholder forum on the implementation of the new pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-19T02:00:00Z","last_updated_date":"2011-04-19T02:00:00Z","reference_number":"EMA/278009/2011","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-first-stakeholder-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"30839","name":"Divergent position on a CVMP opinion on an Article 35 referral of Directive 2001/82/EC for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10%\n\ninjectable and associated names, and related veterinary medicinal pr...","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-12-10T01:00:00Z","last_updated_date":"2014-12-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-35-referral-directive-200182ec-baytril-25-injectable-baytril-5-injectable-baytril-10-injectable-and-associated-names-and-related-veterinary-medicinal-pr_en.pdf"},
    {"id":"30841","name":"EU/3/03/148: Public summary of positive opinion for orphan designation of chimeric-ant-interleukin-6 monoclonal antibody for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-07-08T02:00:00Z","last_updated_date":"2011-11-11T01:00:00Z","reference_number":"EMEA/COMP/1193/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303148-public-summary-positive-opinion-orphan-designation-chimeric-ant-interleukin-6-monoclonal-antibody-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"30842","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone-marrow derived CD34+ cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/65571/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-derived-cd34-cells_en.pdf"},
    {"id":"30843","name":"CHMP summary of positive opinion for Tobi Podhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-09-24T02:00:00Z","last_updated_date":"2010-09-24T02:00:00Z","reference_number":"EMA/CHMP/571131/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tobi-podhaler_en.pdf"},
    {"id":"30847","name":"Final assessment report on Equisetum arvense L., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-03-17T01:00:00Z","reference_number":"EMA/HMPC/278089/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-equisetum-arvense-l-herba_en.pdf"},
    {"id":"30849","name":"Humenza: Package leaflet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-26T01:00:00Z","last_updated_date":"2010-02-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/humenza-package-leaflet_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/humenza-package-leaflet_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/humenza-package-leaflet_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/humenza-package-leaflet_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/humenza-package-leaflet_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/humenza-package-leaflet_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/humenza-package-leaflet_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/humenza-package-leaflet_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/humenza-package-leaflet_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/humenza-package-leaflet_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/humenza-package-leaflet_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/humenza-package-leaflet_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/humenza-package-leaflet_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/humenza-package-leaflet_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/humenza-package-leaflet_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/humenza-package-leaflet_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/humenza-package-leaflet_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/humenza-package-leaflet_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/humenza-package-leaflet_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/humenza-package-leaflet_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/humenza-package-leaflet_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/humenza-package-leaflet_sv.pdf"}},
    {"id":"30850","name":"Presentation -  Multiplicity issues in defining the testing strategy for two large outcome studies (Jennifer Shannon, Rebekkah Brown,\n\nGreg Cicconetti, Rich Davies)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multiplicity-issues-defining-testing-strategy-two-large-outcome-studies-jennifer-shannon-rebekkah-brown-greg-cicconetti-rich-davies_en.pdf"},
    {"id":"30851","name":"Opinion of the CVMP on the establishment of maximum residue limits: Doxycycline","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-03-10T16:00:00Z","last_updated_date":"2015-03-10T16:00:00Z","reference_number":"EMA/CVMP/347869/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-doxycycline_en.pdf"},
    {"id":"30852","name":"Presentation -  GMP phage production for clinical trials (Frenk Smrekar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gmp-phage-production-clinical-trials-frenk-smrekar_en.pdf"},
    {"id":"30853","name":"Generics - Hybrids - Day 80 assessment report - Quality template with guidance - Rev. 05. 21","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:00Z","last_updated_date":"2021-06-25T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/generics-hybrids-day-80-assessment-report-quality-template-guidance-rev-05-21_en.docx"},
    {"id":"30854","name":"Scientific recommendation on classification of advanced therapy medicinal products: ex vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T16:40:00Z","last_updated_date":"2018-06-27T16:40:00Z","reference_number":"EMA/277047/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-ex-vivo-fused-autologous-human-bone-marrow-derived-mesenchymal-stem-cell-allogenic-human-myoblast_en.pdf"},
    {"id":"30856","name":"Final Community herbal monograph on Fraxinus excelsior L. or\n\nFraxinus angustifolia Vahl, folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T16:40:00Z","last_updated_date":"2012-06-18T16:40:00Z","reference_number":"EMA/HMPC/239271/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-fraxinus-excelsior-l-or-fraxinus-angustifolia-vahl-folium_en.pdf"},
    {"id":"30859","name":"Oxytetracycline, tetracycline, chlortetracycline: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxytetracycline-tetracycline-chlortetracycline-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30860","name":"Brief summary of the existing systems on collecting data: Norway","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-norway_en.pdf"},
    {"id":"30861","name":"Issues identified by stakeholders at the workshop - Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-06T11:00:00Z","last_updated_date":"2017-02-06T11:00:00Z","reference_number":"EMA/48099/2017","document_url":"https://www.ema.europa.eu/en/documents/other/issues-identified-stakeholders-workshop-multi-stakeholder-advanced-therapy-medicinal-products-atmps-expert-meeting-exploring-solutions-foster-atmps-development-and-patient-access-europe_en.pdf"},
    {"id":"30862","name":"Work plan for the Pharmacovigilance Inspectors Working Group for 2012","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2012-07-13T02:00:00Z","last_updated_date":"2012-07-13T02:00:00Z","reference_number":"EMA/INS/PhV/313103/2012","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-pharmacovigilance-inspectors-working-group-2012_en.pdf"},
    {"id":"30863","name":"EU/3/14/1367: Public summary of opinion on orphan designation: Bazedoxifene acetate for the treatment of hereditary haemorrhagic telangiectasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"EMA/COMP/639353/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141367-public-summary-opinion-orphan-designation-bazedoxifene-acetate-treatment-hereditary-haemorrhagic-telangiectasia_en.pdf"},
    {"id":"30864","name":"EU/3/16/1698 : Public summary of opinion on orphan designation: Dimethyl fumarate for the treatment of bullous pemphigoid","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/446350/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161698-public-summary-opinion-orphan-designation-dimethyl-fumarate-treatment-bullous-pemphigoid_en.pdf"},
    {"id":"30865","name":"Guideline on carcinogenicity evaluation of medicinal products for the treatment of HIV infection","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-12-13T01:00:00Z","last_updated_date":"2007-12-13T01:00:00Z","reference_number":"EMEA/CHMP/SWP/194898/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-carcinogenicity-evaluation-medicinal-products-treatment-hiv-infection_en.pdf"},
    {"id":"30869","name":"PDCO meeting report 15-17 June 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-07-25T02:00:00Z","reference_number":"EMA/PDCO/469116/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-15-17-june-2011_en.pdf"},
    {"id":"30871","name":"Diovan - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T00:08:21Z","last_updated_date":"2009-03-12T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diovan-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diovan-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diovan-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diovan-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diovan-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diovan-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diovan-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diovan-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diovan-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diovan-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diovan-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diovan-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diovan-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diovan-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diovan-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diovan-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diovan-article-30-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diovan-article-30-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diovan-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diovan-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diovan-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diovan-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"30873","name":"Haemophilus type b and meningococcal group c conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T18:55:00Z","last_updated_date":"2017-10-03T18:57:23Z","reference_number":"EMA/631269/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/haemophilus-type-b-and-meningococcal-group-c-conjugate-vaccine-list-nationally-authorised-medicinal-products-psusa00001583201702_en.pdf"},
    {"id":"30876","name":"Opinion of the CVMP on the establishment of maximum residue limits: Gentamicin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-03-22T15:30:00Z","last_updated_date":"2016-03-22T15:30:00Z","reference_number":"EMA/CVMP/619915/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-gentamicin_en.pdf"},
    {"id":"30877","name":"Draft guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/EWP/431734/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-attention-deficit-hyperactivity-disorder-adhd_en.pdf"},
    {"id":"30878","name":"Oxytetracycline (Extension to honey bees) - Summary opinion of the Committee for Medicinal Products for Veterinary use on the establishment of maximum residue limits","type":"mrl-summary","status":"Adopted","consultation_date":"","first_published_date":"2008-11-14T01:00:00Z","last_updated_date":"2008-11-14T01:00:00Z","reference_number":"EMEA/CVMP/581586/2008","document_url":"https://www.ema.europa.eu/en/documents/mrl-summary/oxytetracycline-extension-honey-bees-summary-opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits_en.pdf"},
    {"id":"30879","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 23-24 July 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-08-15T13:35:00Z","last_updated_date":"2018-08-15T13:35:00Z","reference_number":"EMA/HMPC/510266/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-23-24-july-2018_en.pdf"},
    {"id":"30880","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) - Medicinal product types","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T18:00:00Z","last_updated_date":"2014-07-09T17:15:00Z","reference_number":"EMA/59709/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-medicinal-product-types_en.xls"},
    {"id":"30885","name":"Presentation - Patient reporting in EudraVigilance - a measure of patient engagement? (Marin Banovac)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-reporting-eudravigilance-measure-patient-engagement-marin-banovac_en.pdf"},
    {"id":"30886","name":"Agenda - Workshop on the patient’s voice in the evaluation of medicines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-09-24T18:30:00Z","last_updated_date":"2013-10-29T16:30:00Z","reference_number":"EMA/437597/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-patients-voice-evaluation-medicines_en.pdf"},
    {"id":"30889","name":"Overview of comments received on list on paediatric needs on rheumatology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-06-02T02:00:00Z","last_updated_date":"2006-06-02T02:00:00Z","reference_number":"EMEA/207562/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-list-paediatric-needs-rheumatology_en.pdf"},
    {"id":"30890","name":"Scandonest Article-30 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/599131/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/scandonest-article-30-referral-review-started_en.pdf"},
    {"id":"30893","name":"Opinion of the HMPC on a European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T13:28:00Z","last_updated_date":"2016-10-07T13:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf-0"},
    {"id":"30894","name":"Technical specification - Annex 12a - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-12a-external-service-providers-software-applications-ema201213ict_en.doc"},
    {"id":"30895","name":"Morantel: Note regarding the establishment of maximum residue limits - Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-01-01T01:00:00Z","last_updated_date":"2004-01-01T01:00:00Z","reference_number":"EMEA-V-139723-04","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/morantel-note-regarding-establishment-maximum-residue-limits-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30896","name":"Questions and answers on the withdrawal of the marketing application for Gastromotal","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-11-16T01:00:00Z","last_updated_date":"2007-11-16T01:00:00Z","reference_number":"EMEA/519568/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-gastromotal_sv.pdf"}},
    {"id":"30897","name":"Organisational matters: CHMP meeting of 16-19 December 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/731020/2013","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-16-19-december-2013_en.pdf"},
    {"id":"30901","name":"Fifteenth pandemic pharmacovigilance update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-04-08T02:00:00Z","last_updated_date":"2010-04-08T02:00:00Z","reference_number":"EMA/213238/2010","document_url":"https://www.ema.europa.eu/en/documents/report/fifteenth-pandemic-pharmacovigilance-update_en.pdf"},
    {"id":"30905","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the October 2008 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-10-10T02:09:21Z","last_updated_date":"2008-10-10T02:09:21Z","reference_number":"EMEA/COPM/497503/08","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-october-2008-meeting_en.pdf"},
    {"id":"30906","name":"EU/3/11/884: Public summary of opinion on orphan designation: Methyl O-4-O-[2-[2-[2-[2-[[N-[(1R)-1-[[4-(aminoiminomethyl)phenyl]methyl]-2-oxo-2-(1-piperidinyl)ethyl]-N2-[(4-methoxy-2,3,6-trimethylphenyl)sulfonyl]-L-α-as...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2011-08-16T02:00:00Z","reference_number":"EMA/COMP/420755/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311884-public-summary-opinion-orphan-designation-methyl-o-4-o-2-2-2-2-n-1r-1-4-aminoiminomethylphenylmethyl-2-oxo-2-1-piperidinylethyl-n2-4-methoxy-236-trimethylphenylsulfonyl-l-i_en.pdf"},
    {"id":"30907","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (on acellular amniotic matrix)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/35696/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-burn-eschar-and-debrided-adipose-tissue-cells-acellular-amniotic-matrix_en.pdf"},
    {"id":"30908","name":"Withdrawal assessment report for Oncophage","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-03-12T01:00:00Z","last_updated_date":"2010-03-12T01:00:00Z","reference_number":"EMA/CHMP/775076/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-oncophage_en.pdf"},
    {"id":"30910","name":"Guideline on the processing of renewals in the centralised procedure","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-08-04T11:00:00Z","last_updated_date":"2016-08-04T11:00:00Z","reference_number":"EMEA/CHMP/2990/00 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-processing-renewals-centralised-procedure_en.pdf"},
    {"id":"30911","name":"Concept paper on data requirements to support in use stability claims for immunological veterinary medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-07-20T02:00:00Z","last_updated_date":"2006-07-20T02:00:00Z","reference_number":"EMEA/CVMP/IWP/219089/2006-CON.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-data-requirements-support-use-stability-claims-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"30912","name":"Opinion of HMPC on a Community herbal monograph on Primula veris L. and Primula elatior (L.) Hill, flos","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-04T01:00:00Z","last_updated_date":"2013-03-04T01:00:00Z","reference_number":"EMA/HMPC/332112/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-primula-veris-l-and-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"30913","name":"Public Statement on Ziagen (Abacavir) - Abacavir hypersensitivity cases following an interruption of therapy","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-08-14T02:00:00Z","last_updated_date":"2000-08-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ziagen-abacavir-abacavir-hypersensitivity-cases-following-interruption-therapy_en.pdf"},
    {"id":"30915","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 18-20 March 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T13:25:00Z","last_updated_date":"2015-06-02T18:22:00Z","reference_number":"EMA/PDCO/189408/2015 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-18-20-march-2015_en.pdf"},
    {"id":"30917","name":"Annual report of the Pharmacovigilance Inspectors Working Group for 2015","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2016-07-29T12:10:00Z","last_updated_date":"2016-07-29T12:10:00Z","reference_number":"EMA/INS/PhV/646141/2015","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-pharmacovigilance-inspectors-working-group-2015_en.pdf"},
    {"id":"30918","name":"Questions and answers on the refusal of the marketing authorisation for Qsiva (phentermine / topiramate)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2012-10-19T14:30:00Z","reference_number":"EMA/666052/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-qsiva-phentermine-topiramate_en.pdf-0"},
    {"id":"30919","name":"Draft assessment report on Melilotus officinalis (L.) Lam., herba","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2017-04-12T15:13:00Z","last_updated_date":"2017-04-12T15:13:00Z","reference_number":"EMA/HMPC/44165/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-melilotus-officinalis-l-lam-herba_en.pdf"},
    {"id":"30922","name":"Procedure for reporting of pharmacovigilance inspections requested by the CHMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-12T01:00:00Z","last_updated_date":"2014-06-20T02:00:00Z","reference_number":"EMEA/INS/GCP/391114/2005 Superseded","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-reporting-pharmacovigilance-inspections-requested-chmp_en.pdf"},
    {"id":"30923","name":"Myoson and associated names Article-29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-07-28T02:00:00Z","last_updated_date":"2015-07-28T02:00:00Z","reference_number":"EMA/445101/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/myoson-and-associated-names-article-294-referral-assessment-report_en.pdf"},
    {"id":"30924","name":"Glustin: Product Information as approved by the CHMP on 20 october 2011, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/glustin-product-information-approved-chmp-20-october-2011-pending-endorsement-european-commission_en.pdf"},
    {"id":"30925","name":"Presentation - Topic 3 - Evaluation of new treatment regimens, a clinicians perspective (Andreas Diacon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-3-evaluation-new-treatment-regimens-clinicians-perspective-andreas-diacon_en.pdf"},
    {"id":"30926","name":"Presentation - Procedure for election of Patients’ and Consumers’ Working Party’ co-chair 2013-2016","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T17:00:00Z","last_updated_date":"2013-07-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedure-election-patients-and-consumers-working-party-co-chair-2013-2016_en.pdf"},
    {"id":"30928","name":"Chlorpromazine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-06-01T02:00:00Z","last_updated_date":"1996-06-01T02:00:00Z","reference_number":"EMEA/MRL/111/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/chlorpromazine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30929","name":"Download EPS - Species pictograms - Fish","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-fish_en.zip"},
    {"id":"30930","name":"CHMP summary of positive opinion for Capecitabine Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2012-02-17T01:00:00Z","reference_number":"EMA/CHMP/99418/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-capecitabine-teva_en.pdf"},
    {"id":"30934","name":"New Management Board elects its chairman and approves composition of new scientific committees","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-05-25T02:09:21Z","last_updated_date":"2004-05-25T02:09:21Z","reference_number":"EMEA/D/14394/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-management-board-elects-its-chairman-and-approves-composition-new-scientific-committees_en.pdf"},
    {"id":"30935","name":"Agenda for the 94th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-12-12T16:17:00Z","last_updated_date":"2016-12-19T17:30:00Z","reference_number":"EMA/MB/488455/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-94th-meeting-management-board_en.pdf"},
    {"id":"30936","name":"Draft assessment report on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"EMA/HMPC/749518/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-curcuma-longa-l-c-domestica-valeton-rhizome-revision-1_en.pdf"},
    {"id":"30938","name":"COMP meeting report on the review of applications for orphan designation: May 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T13:30:00Z","last_updated_date":"2014-06-05T17:25:00Z","reference_number":"EMA/231784/2014 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-may-2014_en.pdf"},
    {"id":"30941","name":"Presentation - National experience of application of the requirements for marketing authorisations and other ways of making vaccines available - small MS perspective (Jiri Bures)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-national-experience-application-requirements-marketing-authorisations-and-other-ways-making-vaccines-available-small-ms-perspective-jiri-bures_en.pdf"},
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    {"id":"30945","name":"CHMP summary of positive opinion for DuoCover","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/765467/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-duocover_en.pdf"},
    {"id":"30946","name":"EU/3/03/135: Public summary of positive opinion for orphan designation of decitabine for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2007-05-30T02:00:00Z","reference_number":"EMEA/COMP/2/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303135-public-summary-positive-opinion-orphan-designation-decitabine-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"30947","name":"Agenda - PRAC draft agenda of meeting 4-7 May 2015","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-05-05T17:45:00Z","last_updated_date":"2015-05-05T17:45:00Z","reference_number":"EMA/PRAC/59170/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-4-7-may-2015_en.pdf"},
    {"id":"30948","name":"CHMP post-authorisation summary of positive opinion for RoActemra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/CHMP/236919/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-roactemra_en.pdf-1"},
    {"id":"30949","name":"CHMP statistics: January 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-january-2017_en.pdf"},
    {"id":"30951","name":"Public Statement on the risk of drug interactions with Hypericum perforatum (St John's Wort) and antiretroviral medicinal products","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-02-28T01:00:00Z","last_updated_date":"2000-02-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-risk-drug-interactions-hypericum-perforatum-st-johns-wort-and-antiretroviral-medicinal-products_en.pdf"},
    {"id":"30952","name":"Draft guideline on conduct of pharmacovigilance for medicines used by the paediatric population","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"EMEA/CHMP/235910/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-conduct-pharmacovigilance-medicines-used-paediatric-population_en.pdf"},
    {"id":"30954","name":"List of participants - EMA workshop on the collaboration with general practitioners/family physicians","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T02:00:00Z","last_updated_date":"2016-04-28T02:00:00Z","reference_number":"EMA/202390/2016","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-workshop-collaboration-general-practitionersfamily-physicians_en.pdf"},
    {"id":"30959","name":"Presentation - PRAC patient representative (Marco Greco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prac-patient-representative-marco-greco_en.pdf"},
    {"id":"30961","name":"Methotrexate Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2019-05-17T02:00:00Z","reference_number":"EMA/PRAC/199744/2018 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/referral/methotrexate-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"30964","name":"Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - First version","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-01-10T01:00:00Z","last_updated_date":"2008-01-10T01:00:00Z","reference_number":"EMEA/HMPC/71049/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-first-version_en.pdf"},
    {"id":"30965","name":"Declaration of interests - Christina Peters","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-christina-peters_en.pdf"},
    {"id":"30967","name":"Presentation - Session 3: CNODES common data model pilot project: challenges and opportunities (Robert Platt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-cnodes-common-data-model-pilot-project-challenges-and-opportunities-robert-platt_en.pdf"},
    {"id":"30969","name":"Presentation - Introduction to training offering by European Medicines Agency: Training module PhV-M0","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2016-10-10T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-training-offering-european-medicines-agency-training-module-phv-m0_en.pdf"},
    {"id":"30970","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the sixty-eighth meeting of the committee for veterinary medicinal products took place in London on 10-12 July 2001.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-07-12T14:09:21Z","last_updated_date":"2001-07-12T14:09:21Z","reference_number":"EMEA/CVMP/676/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-sixty-eighth-meeting-committee-veterinary-medicinal-products-took-place-london-10-12-july-2001_en.pdf"},
    {"id":"30972","name":"EU/3/16/1797: Public summary of opinion on orphan designation: Arsenic trioxide for the treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/744548/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161797-public-summary-opinion-orphan-designation-arsenic-trioxide-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"30973","name":"EU/3/14/1306: Public summary of opinion on orphan designation: Cysteamine bitartrate for the treatment of Huntington’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T02:00:00Z","last_updated_date":"2014-09-01T02:00:00Z","reference_number":"EMA/COMP/359565/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141306-public-summary-opinion-orphan-designation-cysteamine-bitartrate-treatment-huntingtons-disease_en.pdf"},
    {"id":"30975","name":"ICH: E 4: Dose response information to support drug registration - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1994-11-01T01:00:00Z","last_updated_date":"1994-11-01T01:00:00Z","reference_number":"CPMP/ICH/378/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-4-dose-response-information-support-drug-registration-step-5_en.pdf"},
    {"id":"30976","name":"EU/3/16/1652: Public summary of opinion on orphan designation: Recombinant human cerebral dopamine neurotrophic factor for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/235531/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161652-public-summary-opinion-orphan-designation-recombinant-human-cerebral-dopamine-neurotrophic-factor-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"30979","name":"EU/3/14/1322: Public summary of opinion on orphan designation: Humanised IgG1 monoclonal antibody against human KIR3DL2 for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2014-10-01T02:00:00Z","reference_number":"EMA/COMP/457016/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141322-public-summary-opinion-orphan-designation-humanised-igg1-monoclonal-antibody-against-human-kir3dl2-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"30980","name":"Call for submission of scientific data relating to the assessment of Marrubii herba; Marrubium vulgare L., herba (white horehound) - First version","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-08-15T02:00:00Z","last_updated_date":"2009-08-15T02:00:00Z","reference_number":"EMEA/HMPC/468681/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-marrubii-herba-marrubium-vulgare-l-herba-white-horehound-first-version_en.pdf"},
    {"id":"30982","name":"Papaverine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/033/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/papaverine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"30984","name":"Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - June 2017","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T13:00:00Z","last_updated_date":"2017-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-dialogue-meeting-june-2017_en.pdf"},
    {"id":"30986","name":"Withdrawal letter: Aripiprazole Mylan","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-01-29T01:00:00Z","last_updated_date":"2016-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aripiprazole-mylan_en.pdf-1"},
    {"id":"30988","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogenic adipose-derived stem cells differentiated in vitro towards the cardiovascular lineage","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:41:00Z","last_updated_date":"2018-01-03T14:41:00Z","reference_number":"EMA/751423/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogenic-adipose-derived-stem-cells-differentiated-vitro-towards-cardiovascular-lineage_en.pdf"},
    {"id":"30991","name":"Superseded list of references for assessment of: Harpagophyti radix Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne (devil's claw root)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMEA/HMPC/476255/2007 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-assessment-harpagophyti-radix-harpagophytum-procumbens-dc-harpagophytum-zeyheri-decne-devils-claw-root_en.pdf"},
    {"id":"30993","name":"Presentation - Regulatory vision of paediatric applications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-vision-paediatric-applications_en.pdf"},
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    {"id":"31002","name":"Procoralan Article-20 procedure - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T13:00:00Z","last_updated_date":"2015-02-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/procoralan-article-20-procedure-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/procoralan-article-20-procedure-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/procoralan-article-20-procedure-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/procoralan-article-20-procedure-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/procoralan-article-20-procedure-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/procoralan-article-20-procedure-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/procoralan-article-20-procedure-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/procoralan-article-20-procedure-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/procoralan-article-20-procedure-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/procoralan-article-20-procedure-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/procoralan-article-20-procedure-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/procoralan-article-20-procedure-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/procoralan-article-20-procedure-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/procoralan-article-20-procedure-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/procoralan-article-20-procedure-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/procoralan-article-20-procedure-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/procoralan-article-20-procedure-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/procoralan-article-20-procedure-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/procoralan-article-20-procedure-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/procoralan-article-20-procedure-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/procoralan-article-20-procedure-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/procoralan-article-20-procedure-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/procoralan-article-20-procedure-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/procoralan-article-20-procedure-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/procoralan-article-20-procedure-annex-iii_no.pdf"}},
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    {"id":"31007","name":"Presentation - Assessing benefit/risk profile of novel immunomodulatory drugs with significant efficacy but potential risks. What data should be presented at MAA? (Michael Panzara)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-assessing-benefitrisk-profile-novel-immunomodulatory-drugs-significant-efficacy-potential-risks-what-data-should-be-presented-maa-michael-panzara_en.pdf"},
    {"id":"31008","name":"European Medicines Agency 2011 priorities for drug safety research: Anti-diabetic drugs: cardio/cerebrovascular adverse effect and pancreatitis / pancreatic cancer","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-07-08T02:00:00Z","last_updated_date":"2010-07-08T02:00:00Z","reference_number":"EMA/425259/2010","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-2011-priorities-drug-safety-research-anti-diabetic-drugs-cardiocerebrovascular-adverse-effect-and-pancreatitis-pancreatic-cancer_en.pdf"},
    {"id":"31010","name":"Myoson Article-29(4) referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-28T02:00:00Z","last_updated_date":"2015-07-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/myoson-article-294-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/myoson-article-294-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/myoson-article-294-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/myoson-article-294-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/myoson-article-294-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/myoson-article-294-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/myoson-article-294-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/myoson-article-294-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/myoson-article-294-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/myoson-article-294-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/myoson-article-294-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/myoson-article-294-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/myoson-article-294-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/myoson-article-294-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/myoson-article-294-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/myoson-article-294-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/myoson-article-294-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/myoson-article-294-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/myoson-article-294-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/myoson-article-294-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/myoson-article-294-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/myoson-article-294-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/myoson-article-294-referral-annex-iii_sv.pdf"}},
    {"id":"31013","name":"EU/3/13/1232: Public summary of opinion on orphan designation: Allantoin for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2015-03-11T01:00:00Z","reference_number":"EMA/COMP/1161/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131232-public-summary-opinion-orphan-designation-allantoin-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"31015","name":"Carmustine (powder and solvent for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010349/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-09T01:00:00Z","last_updated_date":"2016-10-18T15:41:08Z","reference_number":"EMA/97527/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/carmustine-powder-and-solvent-solution-infusion-list-nationally-authorised-medicinal-products-psusa00010349201504_en.pdf"},
    {"id":"31016","name":"Note for guidance revised rapid alert systems (RAS) and non urgent information system (NUIS) in veterinary pharmacovigilance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/CVMP/141/98 Rev 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-revised-rapid-alert-systems-ras-and-non-urgent-information-system-nuis-veterinary-pharmacovigilance_en.pdf"},
    {"id":"31018","name":"Public statement on Celvapan: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T01:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"EMA/820174/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-celvapan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"31022","name":"Silybum marianum: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:09:21Z","last_updated_date":"1999-08-01T02:09:21Z","reference_number":"EMEA/MRL/665/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/silybum-marianum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31024","name":"Minutes of the Extraordinary Management Board meeting for the building approval process of EMA premises in Amsterdam: 6 February 2018","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2018-04-05T19:10:00Z","last_updated_date":"2018-04-05T19:10:00Z","reference_number":"EMA/MB/84505/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-extraordinary-management-board-meeting-building-approval-process-ema-premises-amsterdam-6-february-2018_en.pdf"},
    {"id":"31025","name":"Presentation - Update on revision of risk management plan (RMP) guidance and on pilot of new RMP template (Michael Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-revision-risk-management-plan-rmp-guidance-and-pilot-new-rmp-template-michael-berntgen_en.pdf"},
    {"id":"31026","name":"CHMP summary of positive opinion for Trevaclyn","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/196882/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trevaclyn_en.pdf"},
    {"id":"31027","name":"Presentation - Haemophilia registries: patients’ perspective - European Haemophilia Consortium (EHC) (Radoslaw Kaczmarek)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-haemophilia-registries-patients-perspective-european-haemophilia-consortium-ehc-radoslaw-kaczmarek_en.pdf"},
    {"id":"31028","name":"EU/3/02/121: Public summary of positive opinion for orphan designation of 5-aminolevulinic acid hydrochloride for the intra-operative photodynamic diagnosis of residual glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T01:00:00Z","last_updated_date":"2007-12-04T01:00:00Z","reference_number":"EMEA/COMP/2390/02 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302121-public-summary-positive-opinion-orphan-designation-5-aminolevulinic-acid-hydrochloride-intra-operative-photodynamic-diagnosis-residual-glioma_en.pdf"},
    {"id":"31030","name":"Presentation - Case study 1- First-in-man  (FIM) to commercial for a lyophilised (NBE) product - Session 2 (Michael Siedler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-1-first-man-fim-commercial-lyophilised-nbe-product-session-2-michael-siedler_en.pdf"},
    {"id":"31032","name":"Practical guidance on the extension of Commission decision annexes in the new accession-country language","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-01-31T13:55:46Z","last_updated_date":"2013-07-01T13:10:00Z","reference_number":"EMA/9826/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-guidance-extension-commission-decision-annexes-new-accession-country-language_en.pdf"},
    {"id":"31034","name":"Declaration of interests: Christoph Buchhierl","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:00Z","last_updated_date":"2019-10-25T10:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-christoph-buchhierl_en.pdf"},
    {"id":"31035","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - July 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-07-31T02:00:00Z","last_updated_date":"2007-07-31T02:00:00Z","reference_number":"EMEA/358967/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-july-2007_en.pdf"},
    {"id":"31036","name":"Report - Patient registries workshop","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-17T15:00:00Z","last_updated_date":"2017-02-17T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-patient-registries-workshop_en.pdf"},
    {"id":"31040","name":"CHMP summary of positive opinion for Maci","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2018-07-05T14:00:00Z","reference_number":"EMA/54023/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-maci_en.pdf"},
    {"id":"31041","name":"ICH: Q 4 B Annex 8: Annex 6 to note for evaluation and recommendation of pharmacopoeial texts for use in the ich regions on sterility test and general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-12-01T01:00:00Z","last_updated_date":"2008-12-01T01:00:00Z","reference_number":"EMEA/CHMP/ICH/645592/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-8-annex-6-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-sterility-test-and-general-chapter-step-3_en.pdf"},
    {"id":"31047","name":"Questions and answers on the withdrawal of the marketing authorisation application for Janacti and related names","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-11-22T01:00:00Z","last_updated_date":"2011-11-22T01:00:00Z","reference_number":"EMA/897336/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-janacti-and-related-names_en.pdf"},
    {"id":"31051","name":"Committee for Advanced Therapies (CAT): April 2009 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-04-22T02:00:00Z","last_updated_date":"2009-04-22T02:00:00Z","reference_number":"EMEA/CAT/248054/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-april-2009-meeting-monthly-report_en.pdf"},
    {"id":"31052","name":"Superseded list of references supporting the assessment of  Echinacea purpurea (L.) Moench, radix - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-02-10T01:00:00Z","last_updated_date":"2011-02-10T01:00:00Z","reference_number":"EMA/HMPC/577790/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-echinacea-purpurea-l-moench-radix-first-version_en.pdf"},
    {"id":"31056","name":"EU/3/10/805: Public summary of opinion on orphan designation methylthioninium for the treatment of behavioural variant frontotemporal dementia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2014-01-13T16:20:00Z","reference_number":"EMA/606354/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310805-public-summary-opinion-orphan-designation-methylthioninium-treatment-behavioural-variant-frontotemporal-dementia_en.pdf"},
    {"id":"31057","name":"Adonis Vernalis: Summary Report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-12-01T01:00:00Z","last_updated_date":"1998-12-01T01:00:00Z","reference_number":"EMEA/MRL/543/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/adonis-vernalis-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31059","name":"Somatropin - Article 107 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-04-23T02:00:00Z","last_updated_date":"2012-04-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/somatropin-article-107-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/somatropin-article-107-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/somatropin-article-107-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/somatropin-article-107-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/somatropin-article-107-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/somatropin-article-107-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/somatropin-article-107-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/somatropin-article-107-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/somatropin-article-107-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/somatropin-article-107-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/somatropin-article-107-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/somatropin-article-107-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/somatropin-article-107-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/somatropin-article-107-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/somatropin-article-107-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/somatropin-article-107-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/somatropin-article-107-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/somatropin-article-107-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/somatropin-article-107-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/somatropin-article-107-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/somatropin-article-107-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/somatropin-article-107-referral-annex-iii_sv.pdf"}},
    {"id":"31060","name":"Dabigatran etexilate hard capsule 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-06-26T13:46:01Z","last_updated_date":"2018-06-26T13:46:01Z","reference_number":"EMA/CHMP/805498/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/dabigatran-etexilate-hard-capsule-75-mg-110-mg-and-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"31061","name":"CHMP summary of positive opinion for Xydalba","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-12-19T01:00:00Z","last_updated_date":"2014-12-19T01:00:00Z","reference_number":"EMA/CHMP/757915/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xydalba_en.pdf"},
    {"id":"31063","name":"Guideline on the non-clinical documentation for mixed marketing authorisation applications - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-10-13T02:09:00Z","last_updated_date":"2005-10-13T02:09:00Z","reference_number":"CPMP/SWP/799/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-documentation-mixed-marketing-authorisation-applications-first-version_en.pdf"},
    {"id":"31064","name":"Hearing the Association of the European Self-Medication Industry during the May 2012 Working Party on Community Monographs and Community List meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-10-09T18:00:00Z","last_updated_date":"2012-10-09T18:00:00Z","reference_number":"EMA/HMPC/466421/2012","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-during-may-2012-working-party-community-monographs-and-community-list-meeting_en.pdf"},
    {"id":"31065","name":"Levonelle Article-13 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-08-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/levonelle-article-13-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/levonelle-article-13-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/levonelle-article-13-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/levonelle-article-13-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/levonelle-article-13-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/levonelle-article-13-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/levonelle-article-13-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/levonelle-article-13-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/levonelle-article-13-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/levonelle-article-13-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/levonelle-article-13-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/levonelle-article-13-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/levonelle-article-13-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/levonelle-article-13-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/levonelle-article-13-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/levonelle-article-13-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/levonelle-article-13-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/levonelle-article-13-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/levonelle-article-13-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/levonelle-article-13-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/levonelle-article-13-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/levonelle-article-13-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/levonelle-article-13-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/levonelle-article-13-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/levonelle-article-13-referral-annex-iii_no.pdf"}},
    {"id":"31067","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Lynparza (olaparib) for the treatment of ovarian cancer","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-01-19T01:00:00Z","last_updated_date":"2018-05-28T02:00:00Z","reference_number":"EMA/COMP/685740/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-lynparza-olaparib-treatment-ovarian-cancer_en.pdf"},
    {"id":"31069","name":"Agenda - Veterinary E-Submission Workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-04-29T02:09:21Z","last_updated_date":"2009-04-29T02:09:21Z","reference_number":"EMEA/220682/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-veterinary-e-submission-workshop_en.pdf"},
    {"id":"31073","name":"Draft list of references supporting the assessment of Ginkgo biloba L., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-02-14T01:00:00Z","last_updated_date":"2014-02-14T01:00:00Z","reference_number":"EMA/HMPC/321096/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-ginkgo-biloba-l-folium_en.pdf"},
    {"id":"31075","name":"EU/3/09/689: Public summary of positive opinion for orphan designation of peptides mimicking antigen receptors on autoimmune B cells and autoimmune T cells associated with myasthenia gravis for the treatment of myastheni...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-11-18T00:09:21Z","last_updated_date":"2014-10-07T17:00:00Z","reference_number":"EMEA/COMP/586062/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309689-public-summary-positive-opinion-orphan-designation-peptides-mimicking-antigen-receptors-autoimmune-b-cells-and-autoimmune-t-cells-associated-myasthenia-gravis-treatment-myastheni_en.pdf"},
    {"id":"31077","name":"Public statement on MabCampath (alemtuzumab): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-08-15T12:59:39Z","last_updated_date":"2012-08-15T12:59:39Z","reference_number":"EMA/532364/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-mabcampath-alemtuzumab-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"31078","name":"Traditional herbal medicinal products and simplified registrations for homeopathic medicinal products: pharmacovigilance requirements and EudraVigilance access - Note for clarification","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T11:00:00Z","last_updated_date":"2017-03-02T11:00:00Z","reference_number":"EMA/80556/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/traditional-herbal-medicinal-products-and-simplified-registrations-homeopathic-medicinal-products-pharmacovigilance-requirements-and-eudravigilance-access-note-clarification_en.pdf"},
    {"id":"31082","name":"CHMP summary of positive opinion for Tadalafil Generics","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T13:00:00Z","last_updated_date":"2016-11-11T13:00:00Z","reference_number":"EMA/CHMP/697437/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tadalafil-generics_en.pdf"},
    {"id":"31084","name":"Final list of references supporting the assessment of Olea europaea L., folium - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T01:00:00Z","last_updated_date":"2018-01-04T01:00:00Z","reference_number":"EMA/HMPC/359237/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-olea-europaea-l-folium-first-version_en.pdf"},
    {"id":"31085","name":"Maci Article-20 procedure - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-12-17T01:00:00Z","last_updated_date":"2014-12-17T01:00:00Z","reference_number":"EMA/671958/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/maci-article-20-procedure-assessment-report_en.pdf"},
    {"id":"31087","name":"Note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure - Addendum on acute cardiac failure","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-07-29T02:00:00Z","last_updated_date":"2004-07-29T02:00:00Z","reference_number":"CPMP/EWP/2986/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-cardiac-failure-addendum-acute-cardiac-failure_en.pdf"},
    {"id":"31089","name":"Presentation - Introduction to the workshop: aims and expected outputs (Victoria Hedley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-workshop-aims-and-expected-outputs-victoria-hedley_en.pdf"},
    {"id":"31091","name":"Transatlantic Administrative Simplification Action Plan – Final report on implementation","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T17:56:11Z","last_updated_date":"2011-07-29T17:56:11Z","reference_number":"EMA/440869/2011","document_url":"https://www.ema.europa.eu/en/documents/report/transatlantic-administrative-simplification-action-plan-final-report-implementation_en.pdf"},
    {"id":"31093","name":"Agenda - First EMEA Workshop on European Paediatric Network","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-02-16T00:09:21Z","last_updated_date":"2009-02-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-emea-workshop-european-paediatric-network_en.pdf"},
    {"id":"31095","name":"Presentation - Regulators' perspective - Session 4 (R. Martijn van der Plas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulators-perspective-session-4-r-martijn-van-der-plas_en.pdf"},
    {"id":"31099","name":"Submission of the dossier: Update on electronic submissions and PIM - Paul Kershaw","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/submission-dossier-update-electronic-submissions-and-pim-paul-kershaw_en.pdf"},
    {"id":"31100","name":"Public statement on Osigraft: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-07-27T02:00:00Z","last_updated_date":"2016-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-osigraft-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"31101","name":"Agenda - PRAC draft agenda of meeting 2-5 May 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-05-02T19:28:00Z","last_updated_date":"2017-05-02T19:28:00Z","reference_number":"EMA/PRAC/280563/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-2-5-may-2017_en.pdf"},
    {"id":"31102","name":"Agenda - CAT agenda of the 16-17 October 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T12:15:00Z","last_updated_date":"2014-10-21T12:15:00Z","reference_number":"EMA/CAT/541592/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-17-october-2014-meeting_en.pdf"},
    {"id":"31104","name":"Working party on Herbal Medicinal Products: Final position paper on the use of Herbal Medicinal Products containing Methyleugenol","type":"position","status":"unknown","consultation_date":"","first_published_date":"2004-03-03T01:00:00Z","last_updated_date":"2004-03-03T01:00:00Z","reference_number":"EMEA/HMPWP/337/03","document_url":"https://www.ema.europa.eu/en/documents/position/working-party-herbal-medicinal-products-final-position-paper-use-herbal-medicinal-products-containing-methyleugenol_en.pdf"},
    {"id":"31105","name":"Flupirtine-containing medicines Article-107i procedure - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-08T13:00:00Z","last_updated_date":"2013-03-08T13:00:00Z","reference_number":"EMA/147828/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-annex-i_en.pdf-0"},
    {"id":"31106","name":"Presentation - Patient Registries Initiative Lessons learned from the recent workshops (X. Kurz, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-registries-initiative-lessons-learned-recent-workshops-x-kurz-ema_en.pdf"},
    {"id":"31108","name":"Background and summary of outcome of first workshop on EnprEMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/background-and-summary-outcome-first-workshop-enprema_en.pdf"},
    {"id":"31110","name":"Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T16:00:00Z","last_updated_date":"2021-05-18T13:06:00Z","reference_number":"EMA/764767/2014 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/pre-notification-check-type-ia-variations-ensuring-quality-veterinary-type-ia-variation-submissions_en.pdf"},
    {"id":"31111","name":"Towards an optimal balance between benefits and risks for\n\nveterinary medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-27T00:09:21Z","last_updated_date":"2008-03-27T00:09:21Z","reference_number":"EMEA/161887/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/towards-optimal-balance-between-benefits-and-risks-veterinary-medicines_en.pdf"},
    {"id":"31113","name":"Public statement on Salvia officinalis L., aetheroleum","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2010-10-19T02:00:00Z","last_updated_date":"2016-02-12T16:17:00Z","reference_number":"EMA/HMPC/41843/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-salvia-officinalis-l-aetheroleum_en.pdf"},
    {"id":"31114","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous human gamma-delta T lymphocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-22T12:00:00Z","last_updated_date":"2016-03-22T12:00:00Z","reference_number":"EMA/556557/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-human-gamma-delta-t-lymphocytes_en.pdf"},
    {"id":"31115","name":"Annex I: summary of product characteristics","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-07-01T02:00:00Z","last_updated_date":"2005-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-i-summary-product-characteristics_en.pdf"},
    {"id":"31116","name":"Declaration of interests: Fia Westerholm","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-17T16:52:00Z","last_updated_date":"2017-08-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-fia-westerholm_en.pdf"},
    {"id":"31118","name":"CHMP summary of positive opinion for Steglujan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-01-26T13:00:00Z","reference_number":"EMA/CHMP/12848/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-steglujan_en.pdf"},
    {"id":"31119","name":"Withdrawal assessment report for Orplatna","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-11-10T01:00:00Z","last_updated_date":"2008-11-10T01:00:00Z","reference_number":"EMEA/579702/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-orplatna_en.pdf"},
    {"id":"31120","name":"Letter from Health Canada","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-health-canada_en.pdf"},
    {"id":"31122","name":"CHMP post-authorisation summary of positive opinion for Afinitor","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/CHMP/269366/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-afinitor_en.pdf-0"},
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    {"id":"31124","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon, October 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-08-24T15:25:00Z","last_updated_date":"2018-08-24T15:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-lisbon-october-2018_en.pdf"},
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    {"id":"31148","name":"How can non-conributing agencies be encouraged to participate - Kristin Raudsepp","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-13T00:09:21Z","last_updated_date":"2008-11-13T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/how-can-non-conributing-agencies-be-encouraged-participate-kristin-raudsepp_en.pdf"},
    {"id":"31149","name":"Adaptive Pathways Workshop - List of participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T13:48:00Z","last_updated_date":"2016-12-21T13:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/adaptive-pathways-workshop-list-participants_en.pdf"},
    {"id":"31150","name":"Presentation - Grant frameworks: Japan (Hirofumi Kusunoki)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-grant-frameworks-japan-hirofumi-kusunoki_en.pdf"},
    {"id":"31151","name":"EU/3/12/1097: Public summary of opinion on orphan designation: Lenalidomide for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/808519/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121097-public-summary-opinion-orphan-designation-lenalidomide-treatment-follicular-lymphoma_en.pdf"},
    {"id":"31153","name":"Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T11:50:00Z","last_updated_date":"2015-11-20T11:50:00Z","reference_number":"EMA/CHMP/281371/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-key-aspects-use-pharmacogenomics-pharmacovigilance-medicinal-products_en.pdf"},
    {"id":"31154","name":"Cypermethrin (Extrapolation to all ruminants): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/MRL/890/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cypermethrin-extrapolation-all-ruminants-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31157","name":"Guidance on format of the risk-management plan in the European Union part II: Module SIII - Clinical-trial exposure","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2012-11-08T18:00:00Z","reference_number":"EMA/710081/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-siii-clinical-trial-exposure_en.pdf"},
    {"id":"31158","name":"European Medicines Agency and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) launch ‘ENCePP studies’","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-06-11T02:00:00Z","last_updated_date":"2010-06-11T02:00:00Z","reference_number":"EMA/343605/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-and-european-network-centres-pharmacoepidemiology-pharmacovigilance-encepp-launch-encepp-studies_en.pdf"},
    {"id":"31159","name":"Start of community reviews - CHMP meeting of 19-22 October 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T14:00:00Z","last_updated_date":"2015-10-23T14:00:00Z","reference_number":"EMA/677252/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-19-22-october-2015_en.pdf"},
    {"id":"31160","name":"Gadolinium Article-31 referral – EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T01:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"EMA/625317/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gadolinium-article-31-referral-emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_sv.pdf"}},
    {"id":"31163","name":"Public statement on Clopidogrel Acino Pharma: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-07-26T02:00:00Z","last_updated_date":"2012-07-26T02:00:00Z","reference_number":"EMA/328233/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-acino-pharma-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"31164","name":"Fortum - Article 30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fortum-article-30-referral-annex-iii_en.pdf"},
    {"id":"31165","name":"EU/3/16/1728 : Public summary of opinion on orphan designation: Recombinant humanised monoclonal antibody against human complement component C5a for the treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2017-10-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161728-public-summary-opinion-orphan-designation-recombinant-humanised-monoclonal-antibody-against-human-complement-component-c5a-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"31166","name":"Questions and answers on the updated recommendations for Fabrazyme treatment","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/603545/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-updated-recommendations-fabrazyme-treatment_en.pdf"},
    {"id":"31167","name":"New medicine for hereditary rare disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/510214/2018 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-hereditary-rare-disease_en.pdf-0"},
    {"id":"31168","name":"EU/3/14/1376: Public summary of opinion on orphan designation: Arimoclomol citrate for the treatment of Niemann-Pick disease, type C","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2015-01-16T01:00:00Z","reference_number":"EMA/COMP/637387/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141376-public-summary-opinion-orphan-designation-arimoclomol-citrate-treatment-niemann-pick-disease-type-c_en.pdf"},
    {"id":"31169","name":"EU/3/12/1037: Public summary of opinion on orphan designation: Elotuzumab for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-26T16:30:00Z","last_updated_date":"2016-05-23T16:30:00Z","reference_number":"EMA/COMP/528459/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121037-public-summary-opinion-orphan-designation-elotuzumab-treatment-multiple-myeloma_en.pdf"},
    {"id":"31170","name":"EU/3/09/712: Public summary of opinion on orphan designation of recombinant kallikrein inhibitor for the treatment of Netherton syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2012-05-04T14:00:00Z","reference_number":"EMA/744660/2009 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309712-public-summary-opinion-orphan-designation-recombinant-kallikrein-inhibitor-treatment-netherton-syndrome_en.pdf"},
    {"id":"31171","name":"European Medicines Agency updates on pandemic","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-18T00:09:21Z","last_updated_date":"2009-12-18T00:09:21Z","reference_number":"EMA/816338/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-updates-pandemic_en.pdf"},
    {"id":"31173","name":"Adapalene / benzoyl peroxide: List of nationally authorised medicinal products - PSUSA/00000059/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-12T12:57:00Z","last_updated_date":"2018-07-12T13:02:05Z","reference_number":"EMA/474010/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/adapalene-benzoyl-peroxide-list-nationally-authorised-medicinal-products-psusa00000059201709_en.pdf"},
    {"id":"31174","name":"Overview of comments received on guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2013-05-13T12:30:00Z","last_updated_date":"2013-05-13T12:30:00Z","reference_number":"EMA/HMPC/768094/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"31176","name":"Invitation for expressions of interest - Transatlantic workshop: drug-related progressive multifocal leukoencephalopathy (PML)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-02-05T00:31:00Z","last_updated_date":"2011-02-05T00:31:00Z","reference_number":"EMA/97508/2011","document_url":"https://www.ema.europa.eu/en/documents/other/invitation-expressions-interest-transatlantic-workshop-drug-related-progressive-multifocal-leukoencephalopathy-pml_en.pdf"},
    {"id":"31177","name":"Pancreatin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"EMEA/MRL/062/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/pancreatin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31178","name":"Public statement on Biograstim: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-12-22T01:00:00Z","last_updated_date":"2016-12-22T01:00:00Z","reference_number":"EMEA/H/C/000826","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-biograstim-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"31180","name":"Summary of the evaluation of the proposed paediatric investigation plan: Rosuvastatin / acetylsalicylic acid for treatment of cardiovascular disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/688642/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-evaluation-proposed-paediatric-investigation-plan-rosuvastatin-acetylsalicylic-acid-treatment-cardiovascular-disease_en.pdf"},
    {"id":"31181","name":"Agenda and registration form for: 2nd joint DIA/EMA/CMDh Conference on Variations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-11-12T01:00:00Z","last_updated_date":"2010-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-2nd-joint-diaemacmdh-conference-variations_en.pdf"},
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    {"id":"31183","name":"Opinion following an Article 5(11) referral for Yasminelle and associated names (see Annex I)  International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol: Background 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    {"id":"31233","name":"Presentation - European Medicines Agency: The next 5 years - The innovators perspective (Elias Zerhouni)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-20T01:00:00Z","last_updated_date":"2015-03-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-next-5-years-innovators-perspective-elias-zerhouni_en.pdf"},
    {"id":"31234","name":"Presentation - Objectives of the workshop (Guido Rasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-workshop-guido-rasi_en.pdf"},
    {"id":"31235","name":"EU/3/12/989: Public summary of opinion on orphan designation: 2-Allyl-1-[6-(1-hydroxy-1-methylethyl)pyridin-2-yl]-6-{[4-(4-methylpiperazin-1-yl)phenyl]amino}-1,2-dihydro-3H-pyrazolo[3,4-d]pyrimidin-3-one for the treatmen...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2015-05-27T13:00:00Z","reference_number":"EMA/COMP/223438/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312989-public-summary-opinion-orphan-designation-2-allyl-1-6-1-hydroxy-1-methylethylpyridin-2-yl-6-4-4-methylpiperazin-1-ylphenylamino-12-dihydro-3h-pyrazolo34-dpyrimidin-3-one-treatmen_en.pdf"},
    {"id":"31240","name":"Ivermectin (topical use): CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for\n\nthe implementation - PSUSA/00010376/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-10T02:00:00Z","last_updated_date":"2016-10-17T19:03:14Z","reference_number":"EMA/540331/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-topical-use-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010376201510_en.pdf"},
    {"id":"31242","name":"Status Report on the EudraVigilance-Human Project","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-03-05T00:09:21Z","last_updated_date":"2009-03-05T00:09:21Z","reference_number":"EMEA/MB/45112/2009","document_url":"https://www.ema.europa.eu/en/documents/report/status-report-eudravigilance-human-project_en.pdf"},
    {"id":"31248","name":"Priority access for children during Myozyme supply shortage","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-01-16T00:09:21Z","last_updated_date":"2009-01-16T00:09:21Z","reference_number":"EMEA/13509/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/priority-access-children-during-myozyme-supply-shortage_en.pdf"},
    {"id":"31250","name":"EU/3/13/1212: Public summary of opinion on orphan designation: Ibrutinib for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2021-11-23T01:00:00Z","reference_number":"EMA/COMP/708125/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131212-public-summary-opinion-orphan-designation-ibrutinib-treatment-follicular-lymphoma_en.pdf"},
    {"id":"31253","name":"Lavandulae aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/633/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lavandulae-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31255","name":"Opinion of the HMPC on a European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T14:00:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/M/H/0217","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-revision-2_en.pdf"},
    {"id":"31258","name":"Pholcodine - Article 31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-03-28T02:00:00Z","last_updated_date":"2012-03-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/pholcodine-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/pholcodine-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/pholcodine-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/pholcodine-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/pholcodine-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/pholcodine-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/pholcodine-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/pholcodine-article-31-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/pholcodine-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/pholcodine-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/pholcodine-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/pholcodine-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/pholcodine-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/pholcodine-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/pholcodine-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/pholcodine-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/pholcodine-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/pholcodine-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/pholcodine-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/pholcodine-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/pholcodine-article-31-referral-annex-i_sv.pdf"}},
    {"id":"31259","name":"EU/3/10/818: Public summary of opinion on orphan designation: Human heterologous liver cells (for infusion) for the treatment of citrullinaemia type 1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-19T01:00:00Z","last_updated_date":"2011-01-19T01:00:00Z","reference_number":"EMA/COMP/636230/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310818-public-summary-opinion-orphan-designation-human-heterologous-liver-cells-infusion-treatment-citrullinaemia-type-1_en.pdf"},
    {"id":"31260","name":"Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-02-17T01:00:00Z","last_updated_date":"2005-02-17T01:00:00Z","reference_number":"CPMP/EWP/2339/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function_en.pdf"},
    {"id":"31267","name":"Presentation - PMDA perspectives (Yoshihiro Matsuda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pmda-perspectives-yoshihiro-matsuda_en.pdf"},
    {"id":"31269","name":"Public statement on Focetria: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-02-11T01:00:00Z","last_updated_date":"2016-02-11T01:00:00Z","reference_number":"EMA/72773/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-focetria-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"31270","name":"Guideline on good pharmacovigilance practices: Annex V – Abbreviations (Rev. 1)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-04-25T12:00:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/135814/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-v-abbreviations-rev-1_en.pdf"},
    {"id":"31271","name":"Oxytetracycline, tetracycline, chlortetracycline: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxytetracycline-tetracycline-chlortetracycline-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31273","name":"Anti-fraud strategy: November 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-22T15:00:00Z","last_updated_date":"2015-12-02T18:35:00Z","reference_number":"EMA/591051/2014 Corr","document_url":"https://www.ema.europa.eu/en/documents/other/anti-fraud-strategy-november-2014_en.pdf"},
    {"id":"31276","name":"Presentation - Basis for setting acceptance criteria, Brian Withers, representing EBE","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T02:00:00Z","last_updated_date":"2011-10-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-basis-setting-acceptance-criteria-brian-withers-representing-ebe_en.pdf"},
    {"id":"31277","name":"EU/3/05/298: Public summary of positive opinion for orphan designation of  mifepristone for the treatment of Cushing's syndrome secondary to ectopic ACTH secretion","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-11T02:00:00Z","last_updated_date":"2017-02-10T12:56:00Z","reference_number":"EMEA/COMP/216615/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305298-public-summary-positive-opinion-orphan-designation-mifepristone-treatment-cushings-syndrome-secondary-ectopic-acth-secretion_en.pdf"},
    {"id":"31278","name":"Agenda - European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting on 5 June 2013","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T18:00:00Z","last_updated_date":"2013-07-12T17:00:00Z","reference_number":"EMA/228646/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting-5-june-2013_en.pdf"},
    {"id":"31279","name":"Withdrawal letter: Rotigotine Mylan","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T01:00:00Z","last_updated_date":"2018-01-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-rotigotine-mylan_en.pdf"},
    {"id":"31280","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2013 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T16:00:01Z","last_updated_date":"2013-01-18T16:00:01Z","reference_number":"EMA/CAT/25123/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-january-2013-meeting_en.pdf"},
    {"id":"31284","name":"Closantel (bovine and ovine milk): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-08-18T02:00:00Z","last_updated_date":"2014-08-18T02:00:00Z","reference_number":"EMA/CVMP/751522/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/closantel-bovine-and-ovine-milk-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"31289","name":"EU/3/06/425: Public summary of positive opinion for orphan designation of complement factor H for the treatment of atypical haemolytic uraemic syndrome associated with an inherited abnormality of the complement system","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2013-10-17T18:00:00Z","reference_number":"EMEA/COMP/521235/2006 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306425-public-summary-positive-opinion-orphan-designation-complement-factor-h-treatment-atypical-haemolytic-uraemic-syndrome-associated-inherited-abnormality-complement-system_en.pdf"},
    {"id":"31292","name":"Public statement on the risk of drug interactions with HYPERICUM PERFORATUM (St John's Wort) and antiretroviral medicinal products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-02-28T01:00:00Z","last_updated_date":"2000-02-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/public-statement-risk-drug-interactions-hypericum-perforatum-st-johns-wort-and-antiretroviral-medicinal-products_en.pdf"},
    {"id":"31293","name":"Presentation - CVMP work plan for 2016: highlights and potential implications for new applications and developments (Anja Holm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-work-plan-2016-highlights-and-potential-implications-new-applications-and-developments-anja-holm_en.pdf"},
    {"id":"31295","name":"European Commission-Japan mutual recognition agreement: Sectoral annex on good manufacturing practice for medicinal products - Diplomatic notes","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-04-28T02:00:00Z","last_updated_date":"2004-04-28T02:00:00Z","reference_number":"EMEA/MRA/JP/8/04","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-japan-mutual-recognition-agreement-sectoral-annex-good-manufacturing-practice-medicinal-products-diplomatic-notes_en.pdf"},
    {"id":"31296","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 23–26 February 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T14:00:00Z","last_updated_date":"2015-02-27T14:00:00Z","reference_number":"EMA/CHMP/SAWP/139113/20155 ","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-23-26-february-2015_en.pdf"},
    {"id":"31298","name":"Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 9-11 November 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-11-12T01:00:00Z","last_updated_date":"2010-11-12T01:00:00Z","reference_number":"EMA/CVMP/691376/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-november-2010_en.pdf"},
    {"id":"31299","name":"EU/3/11/931: Public summary of opinion on orphan designation: Plerixafor for adjunctive treatment to cytotoxic therapy in acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMA/COMP/862747/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311931-public-summary-opinion-orphan-designation-plerixafor-adjunctive-treatment-cytotoxic-therapy-acute-myeloid-leukaemia_en.pdf"},
    {"id":"31300","name":"Niflumic: List of nationally authorised medicinal products - PSUSA/00002157/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-05T02:00:00Z","last_updated_date":"2016-10-18T12:37:32Z","reference_number":"EMA/546117/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/niflumic-list-nationally-authorised-medicinal-products-psusa00002157201512_en.pdf"},
    {"id":"31302","name":"8th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1995-12-15T12:09:21Z","last_updated_date":"1995-12-15T12:09:21Z","reference_number":"EMEA/CVMP/168/95","document_url":"https://www.ema.europa.eu/en/documents/press-release/8th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31307","name":"Human medicines highlights - January 2014","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-02-04T16:55:00Z","last_updated_date":"2014-02-04T16:55:00Z","reference_number":"Issue 59","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-january-2014_en.pdf"},
    {"id":"31309","name":"ECDC – future perspectives and integrated approach","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ecdc-future-perspectives-and-integrated-approach_en.pdf"},
    {"id":"31310","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Xermelo (telotristat) for the treatment of carcinoid syndrome","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-10-24T17:09:00Z","last_updated_date":"2017-10-24T17:09:00Z","reference_number":"EMA/550641/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-xermelo-telotristat-treatment-carcinoid-syndrome_en.pdf"},
    {"id":"31311","name":"Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-08-08T16:15:00Z","last_updated_date":"2012-11-15T12:00:00Z","reference_number":"EMA/CHMP/483572/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-chronic-obstructive-pulmonary-disease_en.pdf"},
    {"id":"31312","name":"CHMP summary of positive opinion for Raxone","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/368035/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-raxone_en.pdf"},
    {"id":"31314","name":"Seventeenth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-02-20T01:00:00Z","last_updated_date":"1998-02-20T01:00:00Z","reference_number":"EMEA/MB/006/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/seventeenth-meeting-management-board_en.pdf"},
    {"id":"31317","name":"Mission statement of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-24T18:48:00Z","last_updated_date":"2012-02-24T18:48:00Z","reference_number":"EMA/807680/2011","document_url":"https://www.ema.europa.eu/en/documents/other/mission-statement-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"31318","name":"First medicine for rare blood cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/335706/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-medicine-rare-blood-cancer_en.pdf"},
    {"id":"31319","name":"Initial notices for parallel distribution – June 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-07-09T14:25:00Z","last_updated_date":"2014-07-09T14:25:00Z","reference_number":"EMA/405392/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-june-2014_en.pdf"},
    {"id":"31320","name":"Moxidectin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-09-01T02:00:00Z","last_updated_date":"1996-09-01T02:00:00Z","reference_number":"EMEA/MRL/139/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/moxidectin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31321","name":"Overview of comments received on 'Guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-11-28T12:23:00Z","last_updated_date":"2017-11-28T12:23:00Z","reference_number":"EMA/CHMP/QWP/546045/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-requirements-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-clinical-trials-revision-1_en.pdf"},
    {"id":"31324","name":"CHMP statistics: June 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-june-2016_en.pdf"},
    {"id":"31326","name":"Position paper on definition of a new biological active substance in terms of active, passive immunity and immunomodulators which then constitute a new active ingredient in the context of part b of the annex to council r...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-02-01T01:00:00Z","last_updated_date":"1998-02-01T01:00:00Z","reference_number":"CVMP/IWP/029/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-definition-new-biological-active-substance-terms-active-passive-immunity-and-immunomodulators-which-then-constitute-new-active-ingredient-context-part-b-annex-council-r_en.pdf"},
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    {"id":"31331","name":"Presentation - What do we need to consider to ensure medication adherence of older adults?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-do-we-need-consider-ensure-medication-adherence-older-adults_en.pdf"},
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    {"id":"31335","name":"ICH guideline E2F on development safety update report - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-09-30T02:00:00Z","last_updated_date":"2010-09-30T02:00:00Z","reference_number":"EMA/CHMP/ICH/309348/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e2f-development-safety-update-report-step-5_en.pdf"},
    {"id":"31336","name":"EU/3/16/1712 : Public summary of opinion on orphan designation: 2-((2-ethyl-6-(4-(2-(3-hydroxyazetidin-1-yl)-2-oxoethyl)-piperazin-1-yl)-8-methylimidazo[1,2-alpha]pyridin-3-yl)-(methyl)amino)-4-(4-fluorophenyl)-thiazole-...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-10-04T02:00:00Z","last_updated_date":"2016-10-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161712-public-summary-opinion-orphan-designation-2-2-ethyl-6-4-2-3-hydroxyazetidin-1-yl-2-oxoethyl-piperazin-1-yl-8-methylimidazo12-alphapyridin-3-yl-methylamino-4-4-fluorophenyl-thiazole_en.pdf"},
    {"id":"31338","name":"CHMP post-authorisation summary of positive opinion for Gardasil","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/CHMP/243054/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-gardasil_en.pdf"},
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    {"id":"31341","name":"EU/3/01/053: Public summary of positive opinion for orphan designation of beraprost sodium for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T00:00:00Z","last_updated_date":"2006-01-04T00:00:00Z","reference_number":"EMEA/COMP/14511/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301053-public-summary-positive-opinion-orphan-designation-beraprost-sodium-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"31342","name":"Questions and answers on the withdrawal of the marketing authorisation application for Alendronic Acid/Colecalciferol Mylan (alendronic acid and 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    {"id":"31343","name":"Recognition criteria for self-assessment (EnprEMA): Presentation of comments received during public consultation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enprema-presentation-comments-received-during-public-consultation_en.pdf"},
    {"id":"31345","name":"EMA prepares for Brexit","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-08-01T02:00:00Z","last_updated_date":"2017-08-01T02:00:00Z","reference_number":"MA/466317/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-prepares-brexit_en.pdf"},
    {"id":"31350","name":"Contract 2007/146-691 Instrument for Pre-accession Assistance transition assistance programme: First progress report to the European Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-04-07T02:09:21Z","last_updated_date":"2008-04-07T02:09:21Z","reference_number":"EMEA/180416/2008","document_url":"https://www.ema.europa.eu/en/documents/report/contract-2007146-691-instrument-pre-accession-assistance-transition-assistance-programme-first-progress-report-european-commission_en.pdf"},
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    {"id":"31355","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 11-12 March 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-03-26T16:30:00Z","last_updated_date":"2013-03-26T16:30:00Z","reference_number":"EMA/HMPC/172743/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-11-12-march-2013_en.pdf"},
    {"id":"31356","name":"Cypermethrin (Extension to salmonidae): Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/436/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cypermethrin-extension-salmonidae-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31358","name":"EU/3/18/1981: Public summary of opinion on orphan designation: Mertansine functionalised gold nanoconjugate for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2020-05-20T02:00:00Z","reference_number":"EMA/71251/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181981-public-summary-opinion-orphan-designation-mertansine-functionalised-gold-nanoconjugate-treatment-hepatocellular-carcinoma_en.pdf"},
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    {"id":"31362","name":"Presentation - Effect of a single market: Availability of veterinary medicines: Perspective of IFAH-Europe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-effect-single-market-availability-veterinary-medicines-perspective-ifah-europe_en.pdf"},
    {"id":"31363","name":"Opinion following an Article 6(12) referral for Actira and associated names\n\nInternational Non-Proprietary Name (INN): moxifloxacin: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-08-14T02:08:21Z","last_updated_date":"2008-08-14T02:08:21Z","reference_number":"EMEA/CHMP/524135/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-612-referral-actira-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sv.pdf"}},
    {"id":"31367","name":"Standard operating procedure for certificates of medicinal products","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-04-04T12:00:00Z","last_updated_date":"2012-04-04T12:00:00Z","reference_number":"SOP/INSP/2000","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-certificates-medicinal-products_en.pdf"},
    {"id":"31369","name":"Draft community herbal monograph on Echinacea purpurea (L.) Moench, herba recens","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-03-08T00:09:21Z","last_updated_date":"2007-03-08T00:09:21Z","reference_number":"EMEA/HMPC/104945/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"31371","name":"Initial notices for parallel distribution – 2013","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-06-16T19:01:00Z","last_updated_date":"2014-06-16T19:01:00Z","reference_number":"EMA/345614/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2013_en.pdf"},
    {"id":"31372","name":"Presentation - Implementation of the EudraVigilance access policy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-eudravigilance-access-policy_en.pdf"},
    {"id":"31373","name":"Presentation - Challenges in assessing relative immunogenicity (Paul Chamberlain)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T14:00:00Z","last_updated_date":"2016-03-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-assessing-relative-immunogenicity-paul-chamberlain_en.pdf"},
    {"id":"31380","name":"Foeniculi aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/418/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/foeniculi-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31381","name":"Mandate, objectives and rules of procedure for the CHMP Efficacy Working Party (EWP)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2004-11-18T00:09:21Z","last_updated_date":"2004-11-18T00:09:21Z","reference_number":"EMEA/CHMP/EWP/139722/2004","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-chmp-efficacy-working-party-ewp_en.pdf"},
    {"id":"31382","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 February 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T18:10:00Z","last_updated_date":"2018-03-07T18:10:00Z","reference_number":"EMA/PDCO/124776/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-20-23-february-2018_en.pdf"},
    {"id":"31383","name":"CHMP summary of positive opinion for Provenge","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T14:00:00Z","last_updated_date":"2015-05-19T14:00:00Z","reference_number":"EMA/CHMP/363851/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-provenge_en.pdf"},
    {"id":"31386","name":"Questions and answers on the referral for Extraneal icodextrin 7.5% solution for peritoneal dialysis","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-10-27T00:08:21Z","last_updated_date":"2010-02-10T00:08:21Z","reference_number":"EMEA/CHMP/683039/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-extraneal-icodextrin-75-solution-peritoneal-dialysis_sv.pdf"}},
    {"id":"31387","name":"CHMP positive summary of opinion for PecFent","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2010-06-24T02:00:00Z","reference_number":"EMA/CHMP/344109/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-pecfent_en.pdf"},
    {"id":"31389","name":"Withdrawal letter Ketoconazole AID- SCFM","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T01:00:00Z","last_updated_date":"2015-03-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ketoconazole-aid-scfm_en.pdf"},
    {"id":"31390","name":"Presentation - Optimising the use of the EURD list – the key to the single assessment: Procedural aspects (Robin Ruepp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optimising-use-eurd-list-key-single-assessment-procedural-aspects-robin-ruepp_en.pdf"},
    {"id":"31392","name":"Draft guideline on non-clinical and clinical development of medicinal products for the treatment of nausea and vomiting associated with cancer chemotherapy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-02-17T00:09:21Z","last_updated_date":"2005-02-17T00:09:21Z","reference_number":"CPMP/EWP/4937/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-and-clinical-development-medicinal-products-treatment-nausea-and-vomiting-associated-cancer-chemotherapy_en.pdf"},
    {"id":"31393","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - March 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"EMA/CVMP/168891/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-march-2010_en.pdf"},
    {"id":"31395","name":"European Medicines Agency active-substance-master-file-number request form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-08-14T11:47:00Z","last_updated_date":"2020-10-23T15:10:00Z","reference_number":"EMA/501697/2020","document_url":"https://www.ema.europa.eu/en/documents/template-form/european-medicines-agency-active-substance-master-file-number-request-form_en.docx"},
    {"id":"31396","name":"Tiapride: List of nationally authorised medicinal products - PSUSA/00002944/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T12:00:00Z","last_updated_date":"2016-10-18T19:47:13Z","reference_number":"EMA/268897/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/tiapride-list-nationally-authorised-medicinal-products-psusa00002944201507_en.pdf"},
    {"id":"31397","name":"Merck KGaA withdraws its application for an extension of the indication for Erbitux (cetuximab)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-09-19T13:00:00Z","last_updated_date":"2012-09-19T13:00:00Z","reference_number":"EMA/607000/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/merck-kgaa-withdraws-its-application-extension-indication-erbitux-cetuximab_en.pdf"},
    {"id":"31398","name":"Risk Management of Advanced Therapies, Dossier Requirements - Jan Petracek","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/risk-management-advanced-therapies-dossier-requirements-jan-petracek_en.pdf"},
    {"id":"31399","name":"Presentation - Product subgroup report to task force","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-02T02:00:00Z","last_updated_date":"2017-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-subgroup-report-task-force_en.pdf"},
    {"id":"31403","name":"CHMP summary of positive opinion for Entacapone Orion","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/456583/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-entacapone-orion_en.pdf"},
    {"id":"31406","name":"Presentation - Global strategies to address antimicrobial resistance - Session 1 (Carmem Làºcia Pessoa-Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-global-strategies-address-antimicrobial-resistance-session-1-carmem-laocia-pessoa-silva_en.pdf"},
    {"id":"31407","name":"Minutes of the European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - 3 June 2014","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"EMA/335623/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-3-june-2014_en.pdf"},
    {"id":"31408","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures\n\nAdopted at the CHMP meeting of 12-15 September 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-09-23T18:35:00Z","last_updated_date":"2016-09-23T18:35:00Z","reference_number":"EMA/76623/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-12-15-september-2016_en.pdf"},
    {"id":"31409","name":"Organisational matters - Adopted during the CHMP meeting 18-21 June 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T11:33:00Z","last_updated_date":"2012-06-25T11:33:00Z","reference_number":"EMA/CHMP/410508/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-adopted-during-chmp-meeting-18-21-june-2012_en.pdf"},
    {"id":"31416","name":"Committee for veterinary medicinal products: Meeting of 13 to 14 May 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-05-15T14:49:21Z","last_updated_date":"2003-05-15T14:49:21Z","reference_number":"EMEA/CVMP/484/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-13-14-may-2003_en.pdf"},
    {"id":"31417","name":"Presentation of European Surveillance of Antimicrobial Consumption (ESAC) in human medicine","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-surveillance-antimicrobial-consumption-esac-human-medicine_en.pdf"},
    {"id":"31418","name":"Draft assessment report on Ginkgo biloba L., folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-02-14T01:00:00Z","last_updated_date":"2014-02-14T01:00:00Z","reference_number":"EMA/HMPC/321095/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-ginkgo-biloba-l-folium_en.pdf"},
    {"id":"31419","name":"Amlodipine/olmesartan: List of nationally authorised medicinal products - PSUSA/00002208/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T10:00:00Z","last_updated_date":"2018-01-18T10:39:30Z","reference_number":"EMA/34084/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipineolmesartan-list-nationally-authorised-medicinal-products-psusa00002208201704_en.pdf"},
    {"id":"31422","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 14-17 February 2005","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-02-17T01:00:00Z","last_updated_date":"2005-02-17T01:00:00Z","reference_number":"EMEA/59424/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-14-17-february-2005_en.pdf"},
    {"id":"31423","name":"Follow-up opinion following an Article 35 referral for Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin: Background 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    {"id":"31441","name":"Agenda - PRAC draft agenda of meeting 7-10 July 2014","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2014-07-07T19:30:00Z","last_updated_date":"2014-07-07T19:30:00Z","reference_number":"EMA/PRAC/412722/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-7-10-july-2014_en.pdf"},
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    {"id":"31453","name":"Osseor Article-20 procedure - Product information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-18T02:00:00Z","last_updated_date":"2014-09-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/osseor-article-20-procedure-product-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/osseor-article-20-procedure-product-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/osseor-article-20-procedure-product-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/osseor-article-20-procedure-product-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/osseor-article-20-procedure-product-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/osseor-article-20-procedure-product-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/osseor-article-20-procedure-product-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/osseor-article-20-procedure-product-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/osseor-article-20-procedure-product-information_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/osseor-article-20-procedure-product-information_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/osseor-article-20-procedure-product-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/osseor-article-20-procedure-product-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/osseor-article-20-procedure-product-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/osseor-article-20-procedure-product-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/osseor-article-20-procedure-product-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/osseor-article-20-procedure-product-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/osseor-article-20-procedure-product-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/osseor-article-20-procedure-product-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/osseor-article-20-procedure-product-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/osseor-article-20-procedure-product-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/osseor-article-20-procedure-product-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/osseor-article-20-procedure-product-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/osseor-article-20-procedure-product-information_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/osseor-article-20-procedure-product-information_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/osseor-article-20-procedure-product-information_no.pdf"}},
    {"id":"31455","name":"Overview of comments received on 'Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-03-29T11:25:00Z","last_updated_date":"2016-03-29T11:25:00Z","reference_number":"EMA/754705/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-assessment-cardiovascular-risk-medicinal-products-treatment-cardiovascular-and-metabolic-diseases_en.pdf"},
    {"id":"31457","name":"Scientific recommendation on classification of advanced therapy medicinal products: genetically modified oncolytic adenovirus coated with oligopeptide-end modified Poly (β-amino) esters","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-06-19T11:15:00Z","last_updated_date":"2017-06-19T11:15:00Z","reference_number":"EMA/351239/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-genetically-modified-oncolytic-adenovirus-coated-oligopeptide-end-modified-poly-i2-amino-esters_en.pdf"},
    {"id":"31458","name":"Superseded assessment report for the development of community monographs and for inclusion of herbal substance(s), preparation(s) or combinations thereof in the list: Sambucus nigra L., flos - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2018-06-27T02:09:21Z","reference_number":"EMEA/HMPC/283170/2007Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-development-community-monographs-and-inclusion-herbal-substances-preparations-or-combinations-thereof-list-sambucus-nigra-l-flos-first-version_en.pdf"},
    {"id":"31459","name":"Baclofen: List of nationally authorised medicinal products - PSUSA/00000293/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-19T19:35:00Z","last_updated_date":"2016-10-19T19:35:00Z","reference_number":"EMA/645247/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/baclofen-list-nationally-authorised-medicinal-products-psusa00000293201601_en.pdf"},
    {"id":"31460","name":"Presentation - Towards rules of procedures for public hearings (June Raine, Monika Benstetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-towards-rules-procedures-public-hearings-june-raine-monika-benstetter_en.pdf"},
    {"id":"31461","name":"Overview of comments received on 'qualification opinion of novel methodologies in the predementia stage of Alzheimer’s disease: cerebrospinal-fluid-related biomarkers for drugs affecting amyloid burden'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-05-16T02:00:00Z","last_updated_date":"2011-05-16T02:00:00Z","reference_number":"EMA/252172/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-qualification-opinion-novel-methodologies-predementia-stage-alzheimers-disease-cerebrospinal-fluid-related-biomarkers-drugs-affecting-amyloid-burden_en.pdf"},
    {"id":"31462","name":"EU/3/09/723: Public summary of opinion on orphan designation of recombinant fusion protein linking human coagulation factor IX with human albumin for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-03-03T01:00:00Z","last_updated_date":"2010-03-03T01:00:00Z","reference_number":"EU/3/09/723","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309723-public-summary-opinion-orphan-designation-recombinant-fusion-protein-linking-human-coagulation-factor-ix-human-albumin-treatment-haemophilia-b_en.pdf"},
    {"id":"31463","name":"Metamizole Article-31 referral - List of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T02:00:00Z","last_updated_date":"2018-06-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-list-questions_en.pdf"},
    {"id":"31464","name":"Template - Translations required with the submission of an application for orphan medicinal product designation","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-12-10T00:09:00Z","last_updated_date":"2022-10-06T13:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-translations-required-submission-application-orphan-medicinal-product-designation_en.doc"},
    {"id":"31465","name":"Superseded list of references supporting the assessment report on: Passiflorae herba Passiflora incarnate L., herba (passion flower)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-11-15T00:09:21Z","last_updated_date":"2014-06-19T01:09:21Z","reference_number":"EMEA/HMPC/111180/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-passiflorae-herba-passiflora-incarnate-l-herba-passion-flower_en.pdf"},
    {"id":"31466","name":"Overview of comments received on Community herbal monograph on Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-05-18T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMA/HMPC/564675/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"31468","name":"Tenoxicam: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation -PSUSA/00002893/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-21T11:05:00Z","last_updated_date":"2016-10-19T12:14:39Z","reference_number":"EMA/47501/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/tenoxicam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002893201502_en.pdf"},
    {"id":"31469","name":"Permethrin: List of nationally authorised medicinal products -  PSUSA/00002355/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T17:44:00Z","last_updated_date":"2018-06-07T17:51:10Z","reference_number":"EMA/263468/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/permethrin-list-nationally-authorised-medicinal-products-psusa00002355201707_en.pdf"},
    {"id":"31470","name":"Superseded annex to note for guidance on development pharmaceutics for veterinary products: Decision trees for the selection of sterilisation methods","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-02-01T01:00:00Z","last_updated_date":"2000-02-01T01:00:00Z","reference_number":"EMEA/CVMP/065/99 - Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/superseded-annex-note-guidance-development-pharmaceutics-veterinary-products-decision-trees-selection-sterilisation-methods_en.pdf"},
    {"id":"31471","name":"Questions and Answers on COX-2 Inhibitors - Update","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2005-06-27T02:09:21Z","last_updated_date":"2005-06-27T02:09:21Z","reference_number":"EMEA/210745/2005 corr","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-cox-2-inhibitors-update_en.pdf"},
    {"id":"31475","name":"Cefacetrile: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-09-01T02:00:00Z","last_updated_date":"1998-09-01T02:00:00Z","reference_number":"EMEA/MRL/499/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefacetrile-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31477","name":"Letter from Swissmedic: Arrangement for shared non-public information regarding influenza A (H1N1) pandemic","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-15T01:00:00Z","last_updated_date":"2010-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-swissmedic-arrangement-shared-non-public-information-regarding-influenza-h1n1-pandemic_en.pdf"},
    {"id":"31478","name":"Chapter 4: Structured Substance Information (currently not applicable) of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-01T21:19:00Z","last_updated_date":"2012-03-05T12:00:00Z","reference_number":"EMA/721630/2011","document_url":"https://www.ema.europa.eu/en/documents/other/chapter-4-structured-substance-information-currently-not-applicable-detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf"},
    {"id":"31479","name":"Online strategy and interface design EMA/2012/37/ED - Technical specification annex IV - Summary checklist","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T12:00:00Z","last_updated_date":"2013-06-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/online-strategy-and-interface-design-ema201237ed-technical-specification-annex-iv-summary-checklist_en.pdf"},
    {"id":"31480","name":"Cilostazol: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00010209/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-07T01:00:00Z","last_updated_date":"2016-10-18T15:41:09Z","reference_number":"EMA/269956/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/cilostazol-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010209201502_en.pdf"},
    {"id":"31481","name":"Draft community herbal monograph on Solidago virgaurea L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/285758/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-solidago-virgaurea-l-herba_en.pdf"},
    {"id":"31484","name":"ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T12:00:00Z","reference_number":"EMA/CHMP/ICH/425213/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnologicalbiological-entities_en.pdf"},
    {"id":"31487","name":"Monepantel (Ovine and caprine): European Public MRL Assessment Report (1) (EPMAR) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2009-06-30T02:00:00Z","last_updated_date":"2009-06-30T02:00:00Z","reference_number":"EMEA/CVMP/165324/2008-corr","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/monepantel-ovine-and-caprine-european-public-mrl-assessment-report-1-epmar-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31492","name":"EU/3/16/1783: Public summary of positive opinion for orphan designation of N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide for the treatment of acute pancreatitis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2016-12-13T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161783-public-summary-positive-opinion-orphan-designation-n-5-6-chloro-22-difluorobenzod13dioxol-5-ylpyrazin-2-yl-2-fluoro-6-methylbenzamide-treatment-acute-pancreatitis_en.pdf"},
    {"id":"31493","name":"Withdrawal letter: Zafiride","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-zafiride_en.pdf"},
    {"id":"31496","name":"Presentation - Clinical pharmacogenomics: Premarketing evaluation in early-phase clinical studies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-pharmacogenomics-premarketing-evaluation-early-phase-clinical-studies_en.pdf"},
    {"id":"31498","name":"Annex 1 - Detailed information on conditional marketing authorisations","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T16:20:00Z","last_updated_date":"2017-02-03T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/annex-1-detailed-information-conditional-marketing-authorisations_en.pdf"},
    {"id":"31500","name":"PDCO meeting highlights 10-12 December 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-12-17T00:00:00Z","last_updated_date":"2008-12-17T00:00:00Z","reference_number":"EMEA/PDCO/675823/2008 - corr","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-10-12-december-2008_en.pdf"},
    {"id":"31501","name":"Committee for medicinal products for human use, summary of positive opinion for  Simponi","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/362870/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-simponi_en.pdf"},
    {"id":"31502","name":"CMDh confirms recommendations on restricting use of domperidone-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T17:00:00Z","last_updated_date":"2014-04-25T17:00:00Z","reference_number":"EMA/236452/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/cmdh-confirms-recommendations-restricting-use-domperidone-containing-medicines_en.pdf"},
    {"id":"31504","name":"Lanthanum: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"31505","name":"Centralised Procedure: EFPIA Analysis of PerformanceIndicators Extension of Indications 2005-2006 - Suresh Nair and Marianne Poulmaire","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/centralised-procedure-efpia-analysis-performanceindicators-extension-indications-2005-2006-suresh-nair-and-marianne-poulmaire_en.pdf"},
    {"id":"31507","name":"EU/3/12/1003: Public summary of opinion on orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA for the treatment of adrenoleukodystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-04T17:00:00Z","last_updated_date":"2022-04-04T16:00:00Z","reference_number":"EMA/COMP/282979/2012 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121003-public-summary-opinion-orphan-designation-autologous-haematopoietic-stem-cells-transduced-lentiviral-vector-lenti-d-encoding-human-abcd1-cdna-treatment-adrenoleukodystrophy_en.pdf"},
    {"id":"31508","name":"Withdrawn-product notification: questions and answers - MAH notification time","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-08-11T02:00:00Z","last_updated_date":"2014-08-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawn-product-notification-questions-and-answers-mah-notification-time_en.pdf"},
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    {"id":"31510","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-08-02T19:00:00Z","last_updated_date":"2018-08-02T19:00:00Z","reference_number":"EMA/CAT/514869/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-july-2018_en.pdf"},
    {"id":"31511","name":"Phoxim (Extension to sheep): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-04-01T02:00:00Z","last_updated_date":"2000-04-01T02:00:00Z","reference_number":"EMEA/MRL/735/00-corrigendum","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phoxim-extension-sheep-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31513","name":"Presentation - How to evaluate medications in Multiple Sclerosis when placebo controlled RCTs are not feasible (Luca Massacesi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-evaluate-medications-multiple-sclerosis-when-placebo-controlled-rcts-are-not-feasible-luca-massacesi_en.pdf"},
    {"id":"31514","name":"Kantos Master Article-13 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-02T12:00:00Z","last_updated_date":"2013-05-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kantos-master-article-13-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kantos-master-article-13-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kantos-master-article-13-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kantos-master-article-13-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kantos-master-article-13-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kantos-master-article-13-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kantos-master-article-13-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kantos-master-article-13-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kantos-master-article-13-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kantos-master-article-13-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kantos-master-article-13-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kantos-master-article-13-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kantos-master-article-13-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kantos-master-article-13-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kantos-master-article-13-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kantos-master-article-13-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kantos-master-article-13-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kantos-master-article-13-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kantos-master-article-13-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kantos-master-article-13-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kantos-master-article-13-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kantos-master-article-13-referral-annex-i_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/kantos-master-article-13-referral-annex-i_no.pdf"}},
    {"id":"31515","name":"EU/3/15/1489: Public summary of opinion on orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragme...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/COMP/269696/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151489-public-summary-opinion-orphan-designation-fusion-proteins-composed-genetically-modified-cholera-toxin-subunit-a1-peptides-acetylcholine-receptor-alpha-chain-and-dimer-d-fragme_en.pdf"},
    {"id":"31516","name":"Superseded assessment report on Peumus boldus Molina, folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-01-14T00:09:21Z","last_updated_date":"2017-01-12T10:09:00Z","reference_number":"EMEA/HMPC/591131/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-peumus-boldus-molina-folium_en.pdf"},
    {"id":"31518","name":"EU/3/14/1276: Public summary of opinion on orphan designation of isavuconazonium sulfate for the treatment of mucormycosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/230820/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141276-public-summary-opinion-orphan-designation-isavuconazonium-sulfate-treatment-mucormycosis_en.pdf"},
    {"id":"31519","name":"European Medicines Agency’s privacy statement public and targeted consultations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-02-14T14:00:00Z","last_updated_date":"2020-02-14T14:00:00Z","reference_number":"EMA/472380/2019","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-public-and-targeted-consultations_en.pdf"},
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    {"id":"31523","name":"CHMP statistics: June 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-june-2018_en.pdf"},
    {"id":"31524","name":"Diacerein Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-19T02:00:00Z","last_updated_date":"2014-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diacerein-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diacerein-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diacerein-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diacerein-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diacerein-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diacerein-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diacerein-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diacerein-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/diacerein-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diacerein-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diacerein-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diacerein-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diacerein-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diacerein-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diacerein-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diacerein-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diacerein-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diacerein-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diacerein-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diacerein-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diacerein-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diacerein-article-31-referral-annex-i_sv.pdf"}},
    {"id":"31528","name":"Morantel: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-11-01T01:00:00Z","last_updated_date":"1998-11-01T01:00:00Z","reference_number":"EMEA/MRL/490/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/morantel-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31529","name":"Delapril / manidipine, delapril / indapamide: List of nationally authorised medicinal products - PSUSA/00010496/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-24T14:22:00Z","last_updated_date":"2018-04-24T14:28:00Z","reference_number":"EMA/257641/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/delapril-manidipine-delapril-indapamide-list-nationally-authorised-medicinal-products-psusa00010496201706_en.pdf"},
    {"id":"31531","name":"Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-29T14:00:00Z","last_updated_date":"2013-04-29T14:00:00Z","reference_number":"EMA/256383/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/recommendation-suspend-tetrazepam-containing-medicines-endorsed-cmdh_en.pdf"},
    {"id":"31533","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 30-31 May 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-06-15T11:42:00Z","last_updated_date":"2016-06-15T11:42:00Z","reference_number":"EMA/HMPC/398247/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-30-31-may-2016_en.pdf"},
    {"id":"31534","name":"Presentation - Update on EMA Brexit preparedness (Anthony Humphreys, Monica Dias, Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ema-brexit-preparedness-anthony-humphreys-monica-dias-marie-helene-pinheiro_en.pdf"},
    {"id":"31535","name":"EU/3/03/168: Public summary of positive opinion for orphan designation of herpes simplex 1 virus-thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T00:00:00Z","last_updated_date":"2006-01-04T00:00:00Z","reference_number":"EMEA/COMP/1441/2003","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303168-public-summary-positive-opinion-orphan-designation-herpes-simplex-1-virus-thymidine-kinase-and-truncated-low-affinity-nerve-growth-factor-receptor-transfected-donor-lymphocytes_en.pdf"},
    {"id":"31536","name":"Almitrine Article-31 referral - PRAC recommends withdrawal of oral almitrine-containing medicines: Questions and answers","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T14:00:00Z","last_updated_date":"2013-05-17T14:00:00Z","reference_number":"EMA/286565/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/almitrine-article-31-referral-prac-recommends-withdrawal-oral-almitrine-containing-medicines-questions-and-answers_en.pdf"},
    {"id":"31537","name":"European Medicines Agency gives first opinion for a vaccine for use outside the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T14:00:00Z","last_updated_date":"2012-06-22T14:00:00Z","reference_number":"EMA/421125/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-first-opinion-vaccine-use-outside-eu_en.pdf"},
    {"id":"31539","name":"CHMP post-authorisation summary of positive opinion for Keytruda","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/406390/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda_en.pdf-1"},
    {"id":"31541","name":"35th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-05-12T02:00:00Z","last_updated_date":"2003-05-12T02:00:00Z","reference_number":"EMEA/COMP/1173/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/35th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"31543","name":"Florgane - Article-33 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-10T14:30:00Z","last_updated_date":"2013-07-10T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/florgane-article-33-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/florgane-article-33-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/florgane-article-33-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/florgane-article-33-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/florgane-article-33-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/florgane-article-33-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/florgane-article-33-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/florgane-article-33-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/florgane-article-33-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/florgane-article-33-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/florgane-article-33-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/florgane-article-33-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/florgane-article-33-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/florgane-article-33-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/florgane-article-33-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/florgane-article-33-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/florgane-article-33-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/florgane-article-33-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/florgane-article-33-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/florgane-article-33-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/florgane-article-33-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/florgane-article-33-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"31549","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Imbruvica (ibrutinib) for the treatment of mantle cell lymphoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2014-12-01T01:00:00Z","last_updated_date":"2014-12-01T01:00:00Z","reference_number":"EMA/COMP/535571/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-imbruvica-ibrutinib-treatment-mantle-cell-lymphoma_en.pdf"},
    {"id":"31551","name":"EU/3/16/1716 : Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161716-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-containing-human-mini-dystrophin-gene-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"31554","name":"Final Community herbal monograph on Capsella bursa-pastoris (L.) Medikus, herba  - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T15:30:00Z","last_updated_date":"2011-12-22T15:30:00Z","reference_number":"EMA/HMPC/262766/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-capsella-bursa-pastoris-l-medikus-herba-first-version_en.pdf"},
    {"id":"31556","name":"Work programme for the European Agency for the Evaluation of Medicinal Products 2004","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2004-02-06T00:09:21Z","last_updated_date":"2004-02-06T00:09:21Z","reference_number":"EMEA/MB/58/03/en/FINAL","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_es.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_de.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/work-programme-european-agency-evaluation-medicinal-products-2004_sv.pdf"}},
    {"id":"31557","name":"Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-25T16:10:00Z","last_updated_date":"2016-07-25T16:10:00Z","reference_number":"EMEA/CVMP/EWP/005/2000 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestation-dogs-and-cats-revision-3_en.pdf"},
    {"id":"31558","name":"Report from the 1st EMEA CPMP workshop with patients organisations information and participation","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-03-17T01:00:00Z","last_updated_date":"2005-03-17T01:00:00Z","reference_number":"EMEA/17857/2005/Final","document_url":"https://www.ema.europa.eu/en/documents/report/report-1st-emea-cpmp-workshop-patients-organisations-information-and-participation_en.pdf"},
    {"id":"31561","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) legal basis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T18:00:00Z","last_updated_date":"2021-09-14T09:15:00Z","reference_number":"EMA/59699/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-legal-basis_en.xlsx"},
    {"id":"31562","name":"The next 10 years: A regulatory view: Jordi Llinares","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/next-10-years-regulatory-view-jordi-llinares_en.pdf"},
    {"id":"31564","name":"EU/3/07/432: Public summary of positive opinion for orphan designation of ex-vivo cultured adult human mesenchymal stem cells for the treatment of graft-versus-host-disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2013-06-19T14:00:00Z","reference_number":"EMEA/COMP/29248/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307432-public-summary-positive-opinion-orphan-designation-ex-vivo-cultured-adult-human-mesenchymal-stem-cells-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"31565","name":"Factor VIII Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-12-05T10:30:00Z","last_updated_date":"2017-12-05T10:30:00Z","reference_number":"EMA/763977/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-assessment-report_en.pdf"},
    {"id":"31566","name":"EU/3/14/1311: Public summary of opinion on orphan designation: Gevokizumab for the treatment of Schnitzler syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2018-07-18T02:00:00Z","reference_number":"EMA/COMP/436241/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141311-public-summary-opinion-orphan-designation-gevokizumab-treatment-schnitzler-syndrome_en.pdf"},
    {"id":"31568","name":"ICH: E 5 (R1): Ethnic factors in the acceptability of foreign clinical data - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-09-01T02:00:00Z","last_updated_date":"1998-09-01T02:00:00Z","reference_number":"CPMP/ICH/289/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-5-r1-ethnic-factors-acceptability-foreign-clinical-data-step-5_en.pdf"},
    {"id":"31570","name":"Two new combination therapies against chronic hepatitis C","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T14:00:00Z","last_updated_date":"2016-05-27T14:00:00Z","reference_number":"CHMP/358446/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/two-new-combination-therapies-against-chronic-hepatitis-c_en.pdf"},
    {"id":"31572","name":"EU/3/14/1248: Public summary of opinion on orphan designation: N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide for the treatment of optic ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-03T12:00:00Z","last_updated_date":"2015-06-08T12:00:00Z","reference_number":"EMA/COMP/23335/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141248-public-summary-opinion-orphan-designation-n-carbamoylmethyl-3-2-oxo-pyrrolidin-1-yl-propyl-carbamoyl-methyl-2-2-2-fluoro-phenyl-ethylamino-n-isobutyl-acetamide-treatment-optic_en.pdf"},
    {"id":"31575","name":"EU/3/04/248: Public summary of positive opinion for orphan designation of recombinant histidine tagged idiotype immunoglobulin Fab fragment of clonal B-cell receptors for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-06T00:00:00Z","last_updated_date":"2011-06-01T01:00:00Z","reference_number":"EMEA/COMP/157098/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304248-public-summary-positive-opinion-orphan-designation-recombinant-histidine-tagged-idiotype-immunoglobulin-fab-fragment-clonal-b-cell-receptors-treatment-multiple-myeloma_en.pdf"},
    {"id":"31578","name":"PRAC considers benefits of Kogenate Bayer/Helixate NexGen outweigh risks in previously untreated patients","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-06T01:00:00Z","last_updated_date":"2013-12-06T01:00:00Z","reference_number":"EMA/741427/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-considers-benefits-kogenate-bayerhelixate-nexgen-outweigh-risks-previously-untreated-patients_en.pdf"},
    {"id":"31579","name":"Annex F: Confidentiality undertaking contractors","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-01T02:00:00Z","last_updated_date":"2008-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-f-confidentiality-undertaking-contractors_en.pdf"},
    {"id":"31581","name":"Public statement on the evaluation of bovine spongiform encephalopathies (BSE) - risk via the use of materials of bovine origin in or during the manufacture of vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-02-28T01:00:00Z","last_updated_date":"2001-02-28T01:00:00Z","reference_number":"EMEA/CPMP/BWP/476/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-evaluation-bovine-spongiform-encephalopathies-bse-risk-use-materials-bovine-origin-or-during-manufacture-vaccines_en.pdf"},
    {"id":"31583","name":"Presentation - 2018 European Medicines Agency-industry stakeholder interactions on Brexit related topics (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T02:00:00Z","last_updated_date":"2018-04-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2018-european-medicines-agency-industry-stakeholder-interactions-brexit-related-topics-marie-helene-pinheiro_en.pdf"},
    {"id":"31584","name":"Presentation - Introduction to the programme of the day and panel discussion (Fernand Sauer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-programme-day-and-panel-discussion-fernand-sauer_en.pdf"},
    {"id":"31588","name":"Agenda - CAT agenda of the 18-20 May 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T18:20:00Z","last_updated_date":"2016-05-19T18:20:00Z","reference_number":"EMA/CAT/315321/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-18-20-may-2016-meeting_en.pdf"},
    {"id":"31590","name":"70th meeting of the Committee for Proprietary Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-05-02T02:09:21Z","last_updated_date":"2001-05-02T02:09:21Z","reference_number":"CPMP/1252/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/70th-meeting-committee-proprietary-medicinal-products_en.pdf"},
    {"id":"31591","name":"EU/3/14/1400: Public summary of opinion on orphan designation: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-\n\ncarboxylic acid-L-lysine for the treatment of neurotrophic keratitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T01:00:00Z","last_updated_date":"2015-02-26T01:00:00Z","reference_number":"EMA/COMP/734950/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141400-public-summary-opinion-orphan-designation-1s4r5r7s-34-dibenzyl-2-oxo-68-dioxa-3-azabyciclo321octane-7-carboxylic-acid-l-lysine-treatment-neurotrophic-keratitis_en.pdf"},
    {"id":"31592","name":"Standard operating procedure for handling of financial procedure for parallel distribution","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T10:40:00Z","last_updated_date":"2011-10-17T10:40:00Z","reference_number":"SOP/INSP/2013","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-handling-financial-procedure-parallel-distribution_en.pdf"},
    {"id":"31594","name":"EU/3/16/1632: Public summary of opinion on orphan designation: Florilglutamic acid (18F) for diagnosis of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2016-05-02T02:00:00Z","reference_number":"EMA/COMP/172321/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161632-public-summary-opinion-orphan-designation-florilglutamic-acid-18f-diagnosis-hepatocellular-carcinoma_en.pdf"},
    {"id":"31596","name":"Note for guidance on clinical investigation of medicinal products in the treatment of epileptic disorders","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-11-16T01:00:00Z","last_updated_date":"2000-11-16T01:00:00Z","reference_number":"CPMP/EWP/566/98 rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-epileptic-disorders_en.pdf"},
    {"id":"31599","name":"CVMP post-authorisation summary of negative opinion for Suvaxyn PCV","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-19T18:00:00Z","last_updated_date":"2020-04-15T18:00:00Z","reference_number":"EMA/CVMP/404045/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-negative-opinion-suvaxyn-pcv_en.pdf"},
    {"id":"31600","name":"Final European Union herbal monograph on Origanum majorana L., herba","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T11:35:00Z","last_updated_date":"2016-11-15T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-origanum-majorana-l-herba_en.pdf"},
    {"id":"31601","name":"CHMP post-authorisation summary of positive opinion for Blincyto (II-18)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T16:34:00Z","last_updated_date":"2018-07-27T16:34:00Z","reference_number":"EMA/CHMP/518362/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-blincyto-ii-18_en.pdf"},
    {"id":"31602","name":"Working party on Herbal Medicinal Products: Final proposal for a core data for Primula Radix","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-03-03T01:00:00Z","last_updated_date":"2004-03-03T01:00:00Z","reference_number":"EMEA/HMPWP/243/03","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-final-proposal-core-data-primula-radix_en.pdf"},
    {"id":"31603","name":"CHMP post-authorisation summary of positive opinion for Kiovig","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/495548/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kiovig_en.pdf"},
    {"id":"31605","name":"EU/3/10/746: Public summary of positive opinion: Maytansinoid-conjugated humanised monoclonal antibody against CD56 for the treatment of Merkel-cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2015-03-06T13:30:00Z","reference_number":"EMA/COMP/164684/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310746-public-summary-positive-opinion-maytansinoid-conjugated-humanised-monoclonal-antibody-against-cd56-treatment-merkel-cell-carcinoma_en.pdf"},
    {"id":"31608","name":"Final opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Chlormezanone and Annex C","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1997-09-22T02:08:21Z","last_updated_date":"1997-09-22T02:08:21Z","reference_number":"CPMP/375/97-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-chlormezanone-and-annex-c_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-chlormezanone-and-annex-c_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-chlormezanone-and-annex-c_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/final-opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-chlormezanone-and-annex-c_fr.pdf"}},
    {"id":"31610","name":"Final assessment report on Tilia tomentosa Moench, flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-07-09T18:50:00Z","last_updated_date":"2012-07-09T18:50:00Z","reference_number":"EMA/HMPC/346780/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-tilia-tomentosa-moench-flos_en.pdf"},
    {"id":"31611","name":"Questions and answers on the outcome of an application for Xgeva to be used in patients with castration-resistant prostate cancer at high risk of spreading to the bones","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2013-10-25T15:00:00Z","last_updated_date":"2013-10-25T15:00:00Z","reference_number":"EMA/655170/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-application-xgeva-be-used-patients-castration-resistant-prostate-cancer-high-risk-spreading-bones_en.pdf"},
    {"id":"31612","name":"Superseded list of references supporting the assessment of Hedera helix L., folium - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-01-18T01:00:00Z","last_updated_date":"2018-08-13T02:00:00Z","reference_number":"EMA/HMPC/706540/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-hedera-helix-l-folium-revision-1_en.pdf"},
    {"id":"31613","name":"Assessment of patient, consumer and healthcare professional organisations’ compliance with EMA eligibility criteria","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-06-11T18:30:00Z","last_updated_date":"2022-10-07T14:30:00Z","reference_number":"EMA/698917/2017","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-patient-consumer-and-healthcare-professional-organisations-compliance-ema-eligibility-criteria_en.pdf"},
    {"id":"31615","name":"Agenda - PRAC draft agenda of meeting 26-29 November 2012","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2012-11-26T11:00:00Z","last_updated_date":"2012-11-26T11:00:00Z","reference_number":"EMA/PRAC/519419/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-26-29-november-2012_en.pdf"},
    {"id":"31616","name":"Metformin Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"EMA/82128/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/metformin-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metformin-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metformin-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metformin-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metformin-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metformin-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metformin-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metformin-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metformin-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metformin-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metformin-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metformin-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metformin-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metformin-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metformin-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metformin-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metformin-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metformin-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metformin-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metformin-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metformin-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metformin-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metformin-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/metformin-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/metformin-article-31-referral-annex-i_no.pdf"}},
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    {"id":"31619","name":"Presentation - Product information management - Annex: Example label","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-information-management-annex-example-label_en.pdf"},
    {"id":"31625","name":"Ethical considerations for paediatric trials","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T13:55:00Z","last_updated_date":"2012-10-25T13:55:00Z","reference_number":"EMA/146065/2012","document_url":"https://www.ema.europa.eu/en/documents/report/ethical-considerations-paediatric-trials_en.pdf"},
    {"id":"31627","name":"Committee for medicinal products for human use, summary of positive opinion for Javlor","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/370895/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-javlor_en.pdf"},
    {"id":"31628","name":"Presentation - EU IDMP/SPOR Task Force meeting: Organisations Management Services (OMS) (6. agenda) (Kepa Amutxastegi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-idmpspor-task-force-meeting-organisations-management-services-oms-6-agenda-kepa-amutxastegi_en.pdf"},
    {"id":"31631","name":"Methylphenidate Hexal Article-29 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-05T01:00:00Z","last_updated_date":"2013-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methylphenidate-hexal-article-29-referral-annex-ii_sv.pdf"}},
    {"id":"31633","name":"Procedural Announcement - Temporary derogations to certain eligibility criteria for whole blood and blood components donors in the context of a risk of shortage caused by the Influenza A(H1N1) pandemic","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-01-18T01:00:00Z","last_updated_date":"2010-01-18T01:00:00Z","reference_number":"EMA/715726/2009","document_url":"https://www.ema.europa.eu/en/documents/other/procedural-announcement-temporary-derogations-certain-eligibility-criteria-whole-blood-and-blood-components-donors-context-risk-shortage-caused-influenza-ah1n1-pandemic_en.pdf"},
    {"id":"31635","name":"Draft community herbal monograph on Artemisia absinthium L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/234463/2008 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-artemisia-absinthium-l-herba_en.pdf"},
    {"id":"31636","name":"Lee Parker (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/lee-parker-cv_en.pdf"},
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    {"id":"31638","name":"Superseded overview of comments received on 'Community herbal monograph on Plantago ovata Forssk., seminis tegumentum' (EMEA/HMPC/340857/2005)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2007-02-28T01:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/65916/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-plantago-ovata-forssk-seminis-tegumentum-emeahmpc3408572005_en.pdf"},
    {"id":"31640","name":"Monepantel (bovine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T11:10:00Z","last_updated_date":"2016-11-15T11:10:00Z","reference_number":"EMA/CVMP/351687/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/monepantel-bovine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"31642","name":"EU/3/09/617: Public summary of positive opinion for orphan designation\n\nof 2,2-dimethylbutyric acid, sodium salt for the treatment of beta thalassaemia intermedia and major","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2015-03-20T01:00:00Z","reference_number":"EMEA/COMP/45098/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309617-public-summary-positive-opinion-orphan-designation-22-dimethylbutyric-acid-sodium-salt-treatment-beta-thalassaemia-intermedia-and-major_en.pdf"},
    {"id":"31644","name":"Presentation - Nonclinical and clinical considerations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nonclinical-and-clinical-considerations_en.pdf"},
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    {"id":"31648","name":"Guideline on the processing of renewals in the centralised procedure","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-10-20T02:00:00Z","last_updated_date":"2012-07-02T02:00:00Z","reference_number":"EMEA/CHMP/2990/00 rev. 4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-processing-renewals-centralised-procedure_en.pdf-0"},
    {"id":"31649","name":"Letter from the European Medicines Agency: Arrangement for shared non-public information regarding influenza A (H1N1) pandemic with Swissmedic","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-15T01:00:00Z","last_updated_date":"2010-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-medicines-agency-arrangement-shared-non-public-information-regarding-influenza-h1n1-pandemic-swissmedic_en.pdf"},
    {"id":"31651","name":"Overview of comments received on Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T14:45:00Z","last_updated_date":"2014-04-29T14:45:00Z","reference_number":"EMA/HMPC/555110/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"31657","name":"Article 57 project","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-19T01:00:00Z","last_updated_date":"2015-03-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/article-57-project_en.pdf"},
    {"id":"31658","name":"EU/3/16/1756: Public summary of positive opinion for orphan designation of mogamulizumab for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/616732/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161756-public-summary-positive-opinion-orphan-designation-mogamulizumab-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"31659","name":"Presentation - Dose selection in early paediatric development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-13T02:09:21Z","last_updated_date":"2008-04-13T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-selection-early-paediatric-development_en.pdf"},
    {"id":"31660","name":"CHMP summary of positive opinion for Rydapt","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/CHMP/263985/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rydapt_en.pdf"},
    {"id":"31661","name":"European Medicines Agency recommendation on the procedural aspects and dossier requirements for the consultation to the European Medicines Agency by a notified body on an ancillary medicinal substance or an ancillary hum...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-02-27T16:26:00Z","last_updated_date":"2012-02-27T16:26:00Z","reference_number":"EMA/CHMP/578661/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-recommendation-procedural-aspects-and-dossier-requirements-consultation-european-medicines-agency-notified-body-ancillary-medicinal-substance-or-ancillary-hum_en.pdf"},
    {"id":"31663","name":"Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 01 to 88","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2014-10-02T19:00:00Z","last_updated_date":"2014-10-02T19:00:00Z","reference_number":"EMA/342115/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-publication-and-access-clinical-trial-data-ema2408102013-stakeholder-01-88_en.pdf"},
    {"id":"31668","name":"Recognition criteria for self assessment - Enpr-EMA: PENTA: Paediatric European Network for the Treatment of AIDS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817622/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-penta-paediatric-european-network-treatment-aids_en.pdf"},
    {"id":"31670","name":"Presentation - Introduction (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T17:00:00Z","last_updated_date":"2016-05-27T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-marie-helene-pinheiro_en.pdf"},
    {"id":"31672","name":"CHMP post-authorisation summary of positive opinion for Revlimid","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/CHMP/244652/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revlimid_en.pdf-1"},
    {"id":"31673","name":"EU/3/17/1828: Public summary of opinion on orphan designation: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/83404/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171828-public-summary-opinion-orphan-designation-1-22-difluoro-2h-13-benzodioxol-5-yl-n-1-2r-23-dihydroxypropyl-6-fluoro-2-1-hydroxy-2-methylpropan-2-yl-1h-indol-5-ylcyclopropane-1-carboxamide_en.pdf"},
    {"id":"31674","name":"Committee for medicinal products for human use summary of positive opinion for Fablyn","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T00:09:21Z","last_updated_date":"2008-12-18T00:09:21Z","reference_number":"EMEA/CHMP/609979/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-fablyn_en.pdf"},
    {"id":"31676","name":"Product-information-quality form: For applicants when submitting revised English product information to the European Medicines Agency - Day 121","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-06-19T02:09:21Z","last_updated_date":"2010-05-06T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/product-information-quality-form-applicants-when-submitting-revised-english-product-information-european-medicines-agency-day-121_en.doc"},
    {"id":"31677","name":"Presentation - When science and regulatory action meet reality: barriers and critical success factors to managing risk and the salience of trust (Patrick Brown)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-when-science-and-regulatory-action-meet-reality-barriers-and-critical-success-factors-managing-risk-and-salience-trust-patrick-brown_en.pdf"},
    {"id":"31679","name":"Letrozole : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"31682","name":"Workshop on Medicines for the Treatment of Pain in children - List of participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-06-22T02:09:21Z","last_updated_date":"2005-06-22T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-medicines-treatment-pain-children-list-participants_en.pdf"},
    {"id":"31683","name":"EU/3/15/1473: Public summary of positive opinion for orphan designation of Lenalidomide for the treatment of marginal zone lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-21T14:00:00Z","last_updated_date":"2015-05-21T14:00:00Z","reference_number":"EMA/COMP/210061/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151473-public-summary-positive-opinion-orphan-designation-lenalidomide-treatment-marginal-zone-lymphoma_en.pdf"},
    {"id":"31684","name":"Presentation - Health Technology Assessment: Impact on Regulators","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-18T02:00:00Z","last_updated_date":"2011-07-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-health-technology-assessment-impact-regulators_en.pdf"},
    {"id":"31685","name":"List of participants - Workshop on measuring the impact of pharmacovigilance activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"EMA/757893/2016","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-workshop-measuring-impact-pharmacovigilance-activities_en.pdf"},
    {"id":"31686","name":"European Medicines Agency publishes final ‘Road map to 2015’","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-01-26T10:58:17Z","last_updated_date":"2011-01-26T10:58:17Z","reference_number":"EMA/61367/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-publishes-final-road-map-2015_en.pdf"},
    {"id":"31688","name":"Condurango cortex: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/14/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/condurango-cortex-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"31690","name":"Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Vectibix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2011-03-18T01:00:00Z","reference_number":"EMA/213981/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-vectibix_en.pdf"},
    {"id":"31691","name":"Valsartan Art 31 - list NAPs and CAPs","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-27T18:00:00Z","last_updated_date":"2019-05-17T16:16:00Z","reference_number":"EMA/480845/2018 rev2","document_url":"https://www.ema.europa.eu/en/documents/referral/valsartan-art-31-list-naps-and-caps_en.pdf"},
    {"id":"31693","name":"European Medicines Agency recommends restricted use for piroxicam","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-25T02:00:00Z","last_updated_date":"2007-06-25T02:00:00Z","reference_number":"EMEA/265144/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricted-use-piroxicam_en.pdf"},
    {"id":"31695","name":"Agenda - Patient Registries workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-09-19T12:29:00Z","last_updated_date":"2016-09-19T12:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-patient-registries-workshop_en.pdf-0"},
    {"id":"31696","name":"Overview of comments received on the draft guideline on medicinal products for the treatment of insomnia","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-02T01:00:00Z","last_updated_date":"2011-03-02T01:00:00Z","reference_number":"EMA/607700/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-medicinal-products-treatment-insomnia_en.pdf"},
    {"id":"31699","name":"Presentation - Draft action plan: Collection of data by animal species  (Kari Grave, Jordi Torren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-action-plan-collection-data-animal-species-kari-grave-jordi-torren_en.pdf"},
    {"id":"31700","name":"Template for European Union risk-management plan (superseded)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2006-09-27T02:00:00Z","last_updated_date":"2006-09-27T02:00:00Z","reference_number":"EMEA/192632/2006","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-european-union-risk-management-plan-superseded_en.pdf"},
    {"id":"31702","name":"Assessment report for fibrinogen-containing solutions for sealant authorised for administration by spray application (Tisseel, Tissucol, Artiss, Beriplast P and associated names)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2013-04-02T02:00:00Z","reference_number":"EMA/96130/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-fibrinogen-containing-solutions-sealant-authorised-administration-spray-application-tisseel-tissucol-artiss-beriplast-p-and-associated-names_en.pdf"},
    {"id":"31705","name":"Presentation - Preliminary results of survey on collaboration between Enpr-EMA networks and industry for the conduct of industry-funded clinical trials (Benjamin Pelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preliminary-results-survey-collaboration-between-enpr-ema-networks-and-industry-conduct-industry-funded-clinical-trials-benjamin-pelle_en.pdf"},
    {"id":"31706","name":"Minutes of the sixty-fourth meeting of the Management Board: 1 October 2009","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2009-11-13T00:09:21Z","last_updated_date":"2009-11-13T00:09:21Z","reference_number":"EMEA/MB/642672/2009/EN/Adopted","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-sixty-fourth-meeting-management-board-1-october-2009_sv.pdf"}},
    {"id":"31707","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2014","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-12-11T16:40:00Z","last_updated_date":"2015-12-11T16:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2014_en.pdf"},
    {"id":"31708","name":"CHMP summary of positive opinion for Zoledronic acid Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/417185/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zoledronic-acid-mylan_en.pdf"},
    {"id":"31710","name":"CHMP summary of positive opinion for Rxulti","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/344772/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rxulti_en.pdf"},
    {"id":"31711","name":"EU/3/09/627: Public summary of positive opinion for orphan designation of lintuzumab for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-12T02:00:00Z","last_updated_date":"2011-11-11T01:00:00Z","reference_number":"EMEA/COMP/161880/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309627-public-summary-positive-opinion-orphan-designation-lintuzumab-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"31712","name":"European Medicines Agency budget for 2015","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-12-22T15:30:00Z","last_updated_date":"2014-12-22T15:30:00Z","reference_number":"EMA/MB/73904/2014","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2015_en.pdf"},
    {"id":"31714","name":"Superseded list of references supporting the assessment of Trigonella foenum-graecum L., semen","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2022-08-30T02:00:00Z","last_updated_date":"2022-08-30T02:00:00Z","reference_number":"EMA/HMPC/146222/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-trigonella-foenum-graecum-l-semen_en.pdf"},
    {"id":"31715","name":"Agenda - 10 years of the Orphan Regulation in Europe conference","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2010-02-04T01:00:00Z","last_updated_date":"2010-04-28T02:00:00Z","reference_number":"EMA/63930/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-10-years-orphan-regulation-europe-conference_en.pdf"},
    {"id":"31717","name":"Committee for Orphan Medicinal Products: July 2005 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-07-21T02:00:00Z","last_updated_date":"2005-07-21T02:00:00Z","reference_number":"EMEA/COMP/233637/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-july-2005-meeting_en.pdf"},
    {"id":"31718","name":"Draft list of references supporting the assessment of Harpagophytum procumbens DC. and/or Harpagophytum zeheyri Decne., radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-02-15T12:00:00Z","last_updated_date":"2016-02-15T12:00:00Z","reference_number":"EMA/HMPC/627059/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-harpagophytum-procumbens-dc-andor-harpagophytum-zeheyri-decne-radix_en.pdf"},
    {"id":"31719","name":"Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-30T15:00:00Z","last_updated_date":"2013-05-30T15:00:00Z","reference_number":"EMA/318380/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/benefits-diane-35-and-its-generics-outweigh-risks-certain-patient-groups-prac-recommendation-endorsed-cmdh_en.pdf"},
    {"id":"31720","name":"Draft list of references supporting the assessment of Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2012-06-25T12:12:00Z","last_updated_date":"2012-06-25T12:12:00Z","reference_number":"EMA/HMPC/897341/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-paullinia-cupana-kunth-ex-hbk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
    {"id":"31722","name":"Methyl salicylate / levomenthol / DL-camphor: List of nationally authorised medicinal products - PSUSA/00010117/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-06T10:30:00Z","last_updated_date":"2018-03-06T10:33:00Z","reference_number":"EMA/21211/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/methyl-salicylate-levomenthol-dl-camphor-list-nationally-authorised-medicinal-products-psusa00010117201704_en.pdf"},
    {"id":"31723","name":"European Medicines Agency budget for 2006","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2005-12-15T01:00:00Z","last_updated_date":"2005-12-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2006_en.pdf"},
    {"id":"31724","name":"News bulletin for pharmacovigilance programme update - Issue 5","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-10-13T16:35:00Z","last_updated_date":"2015-10-13T16:35:00Z","reference_number":"Issue 5","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-pharmacovigilance-programme-update-issue-5_en.pdf"},
    {"id":"31725","name":"Draft assessment report on Aesculus hippocastanum L., cortex","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-10-26T12:37:02Z","last_updated_date":"2011-10-26T12:37:02Z","reference_number":"EMA/HMPC/354157/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-aesculus-hippocastanum-l-cortex_en.pdf"},
    {"id":"31729","name":"Standard Operating Procedure for Check of expert for product evaluation","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2005-09-21T02:00:00Z","last_updated_date":"2005-09-21T02:00:00Z","reference_number":"SOP/H/3022","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-check-expert-product-evaluation_en.pdf"},
    {"id":"31730","name":"Presentation: Working Group on public-private partnership","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-public-private-partnership_en.pdf"},
    {"id":"31731","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Arzerra (ofatumumab) for the treatment of chronic lymphocytic leukaemia","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-04-11T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMA/COMP/430552/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-arzerra-ofatumumab-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"31733","name":"Monthly Report - Pharmacovigilance Working Party (PHVWP) December 2009 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-01-07T01:00:00Z","last_updated_date":"2010-01-07T01:00:00Z","reference_number":"EMA/816248/2009","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-december-2009-plenary-meeting_en.pdf"},
    {"id":"31734","name":"Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T18:30:00Z","last_updated_date":"2017-12-11T18:30:00Z","reference_number":"EMA/488783/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/best-practice-guide-measures-improving-predictability-submissionsresponses-and-adherence-communicated-submissionresponses-deadlines_en.pdf"},
    {"id":"31736","name":"Hexaminolevulinate hydrochloride: List of nationally authorised products - PSUSA/00001606/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2016-10-17T17:15:44Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/hexaminolevulinate-hydrochloride-list-nationally-authorised-products-psusa00001606201409_en.pdf"},
    {"id":"31737","name":"Mandate, objectives and rules of procedure for the CVMP Antimicrobials Working Party (AWP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-14T18:15:00Z","last_updated_date":"2018-12-19T10:00:00Z","reference_number":"EMA/CVMP/AWP/749774/2012 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-cvmp-antimicrobials-working-party-awp_en.pdf"},
    {"id":"31739","name":"Superseded community herbal monograph on Vitis vinifera L., folium - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-03T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"EMA/HMPC/16635/2009 Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-vitis-vinifera-l-folium-first-version_en.pdf"},
    {"id":"31741","name":"Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-05-29T02:08:21Z","last_updated_date":"2007-05-29T02:08:21Z","reference_number":"EMEA/144030/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-30-referral-xefo-and-associated-names-international-non-proprietary-name-inn-lornoxicam-background-information_sv.pdf"}},
    {"id":"31742","name":"Towards optimising risk minimisation measures: report on European Medicines Agency’s workshop on risk minimisation measures","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"EMA/628259/2015","document_url":"https://www.ema.europa.eu/en/documents/report/towards-optimising-risk-minimisation-measures-report-european-medicines-agencys-workshop-risk-minimisation-measures_en.pdf"},
    {"id":"31747","name":"EU/3/07/522: Public summary of positive opinion for (manganese, dichloro [(4aR, 13aR, 17aR, 21aR)-1, 2, 3, 4, 4a, 5, 6, 12, 13, 13a, 14, 15, 16, 17, 17a, 18, 19, 20, 21, 21a-eicosahydro-11, 7-nitrilo-7H-dibenzo[ b,h] [1,...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/577300/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307522-public-summary-positive-opinion-manganese-dichloro-4ar-13ar-17ar-21ar-1-2-3-4-4a-5-6-12-13-13a-14-15-16-17-17a-18-19-20-21-21a-eicosahydro-11-7-nitrilo-7h-dibenzo-bh-1_en.pdf"},
    {"id":"31748","name":"Emtricitabine/Tenofovir Disoproxil film-coated tablets 200mg/245 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/675839/2014 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/emtricitabinetenofovir-disoproxil-film-coated-tablets-200mg245-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"31749","name":"EU/3/13/1188: Public summary of opinion on orphan designation:\n\nRecombinant fusion protein linking coagulation factor VIIa with albumin for the treatment of congenital factor VII deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-10-31T01:00:00Z","last_updated_date":"2013-10-31T01:00:00Z","reference_number":"EMA/COMP/556625/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131188-public-summary-opinion-orphan-designation-recombinant-fusion-protein-linking-coagulation-factor-viia-albumin-treatment-congenital-factor-vii-deficiency_en.pdf"},
    {"id":"31752","name":"EU/3/18/1991: Public summary of opinion on orphan designation: Docosahexaenoic acid ethyl ester for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"EMA/125843/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181991-public-summary-opinion-orphan-designation-docosahexaenoic-acid-ethyl-ester-treatment-sickle-cell-disease_en.pdf"},
    {"id":"31753","name":"EU/3/07/474: Public summary of positive opinion for orphan designation of alpha-1proteinase inhibitor (inhalation use) for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-01-17T01:00:00Z","last_updated_date":"2008-01-17T01:00:00Z","reference_number":"EMEA/351455/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307474-public-summary-positive-opinion-orphan-designation-alpha-1proteinase-inhibitor-inhalation-use-treatment-cystic-fibrosis_en.pdf"},
    {"id":"31755","name":"Announcement - Sixth Enpr-EMA workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/announcement-sixth-enpr-ema-workshop_en.pdf"},
    {"id":"31757","name":"CHMP summary of positive opinion for Tookad","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/CHMP/449509/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tookad_en.pdf"},
    {"id":"31758","name":"EU/3/04/206: Public summary of positive opinion for orphan designation of muramyl tripeptide phosphatidyl ethanolamine for the treatment of osteosarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2019-07-11T02:00:00Z","reference_number":"EMEA/COMP/373/04 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304206-public-summary-positive-opinion-orphan-designation-muramyl-tripeptide-phosphatidyl-ethanolamine-treatment-osteosarcoma_en.pdf"},
    {"id":"31760","name":"Questions and answers on Tazocin and associated names (piperacillin and tazobactam, 2/0.25 g and 4/0.5 g powder for solution for infusion)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/656918/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-tazocin-and-associated-names-piperacillin-and-tazobactam-2025-g-and-405-g-powder-solution-infusion_sv.pdf"}},
    {"id":"31761","name":"Signal assessment report - template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-10-29T10:00:00Z","last_updated_date":"2022-10-21T09:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/signal-assessment-report-template_en.docx"},
    {"id":"31763","name":"Presentation - European Food Safety (EFSA), antimicrobial resistance, stakeholders - Session 4 (Pietro Stella)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-food-safety-efsa-antimicrobial-resistance-stakeholders-session-4-pietro-stella_en.pdf"},
    {"id":"31764","name":"EU/3/01/056: Public summary of positive opinion for orphan designation: Recombinant human acid sphingomyelinase for the treatment of Niemann-Pick disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/142984/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301056-public-summary-positive-opinion-orphan-designation-recombinant-human-acid-sphingomyelinase-treatment-niemann-pick-disease_en.pdf"},
    {"id":"31765","name":"Withdrawal letter: Begedina","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-begedina_en.pdf"},
    {"id":"31766","name":"Presentation - Update on the revision of the new package leaflet (PL) template","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-23T02:00:00Z","last_updated_date":"2011-05-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-revision-new-package-leaflet-pl-template_en.pdf"},
    {"id":"31768","name":"Presentation - Impact of specific formulations on anthelmintic resistance development (D. Murphy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-specific-formulations-anthelmintic-resistance-development-d-murphy_en.pdf"},
    {"id":"31773","name":"Questions and answers for the guidance on collection and\n\nprovision of national data on antimicrobial use by animal\n\nspecies/categories (EMA/489035/2016-Rev.1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T17:30:00Z","last_updated_date":"2018-02-23T15:07:00Z","reference_number":"EMA/716249/2016-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-guidance-collection-and-provision-national-data-antimicrobial-use-animal-speciescategories-ema4890352016-rev1_en.pdf"},
    {"id":"31774","name":"EMA recommends approval of treatment for attention deficit hyperactivity disorder","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/CHMP/494404/2015 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-approval-treatment-attention-deficit-hyperactivity-disorder_en.pdf"},
    {"id":"31775","name":"Guideline on parametric release","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-10-16T02:00:00Z","last_updated_date":"2006-10-16T02:00:00Z","reference_number":"EMEA/CVMP/QWP/339588/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-parametric-release_en.pdf"},
    {"id":"31776","name":"Key elements for the summaries of product characteristics of non-selective NSAIDs adopted by the CHMP during its meeting in October 2005","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2005-10-17T02:09:21Z","last_updated_date":"2005-10-17T02:09:21Z","reference_number":"EMEA/CHMP/343456/2005","document_url":"https://www.ema.europa.eu/en/documents/other/key-elements-summaries-product-characteristics-non-selective-nsaids-adopted-chmp-during-its-meeting-october-2005_en.pdf"},
    {"id":"31777","name":"Presentation - Pharmacovigilance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:54Z","last_updated_date":"2012-06-15T17:10:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance_en.pdf-0"},
    {"id":"31780","name":"Agenda - Veterinary Scientific Advice Workshop - Introduction","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2008-05-08T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-veterinary-scientific-advice-workshop-introduction_en.pdf"},
    {"id":"31781","name":"CHMP post-authorisation summary of positive opinion for Ilaris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/CHMP/827091/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ilaris_en.pdf-3"},
    {"id":"31783","name":"Presentation - Experience of paediatric formulations in marketing authorisation applications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-30T01:00:00Z","last_updated_date":"2012-01-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-paediatric-formulations-marketing-authorisation-applications_en.pdf"},
    {"id":"31784","name":"CHMP summary of positive opinion for Zontivity","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2017-09-20T02:00:00Z","reference_number":"EMA/CHMP/666694/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zontivity_en.pdf"},
    {"id":"31785","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 29 May-01 June 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-06-20T16:00:00Z","last_updated_date":"2018-06-20T16:00:00Z","reference_number":"EMA/PDCO/387556/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-29-may-01-june-2018_en.pdf"},
    {"id":"31786","name":"European Medicines Agency 2009 mid-year report shows it is still on target, despite influenza pandemic activities","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-10-26T00:09:21Z","last_updated_date":"2010-02-11T21:21:55Z","reference_number":"EMEA/MB/681032/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-2009-mid-year-report-shows-it-still-target-despite-influenza-pandemic-activities_en.pdf"},
    {"id":"31787","name":"Turkey - Ministry of Health, General Directorate, Y Karabey","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/turkey-ministry-health-general-directorate-y-karabey_en.pdf"},
    {"id":"31788","name":"EU/3/16/1688: Public summary of opinion on orphan designation: Setmelanotide for the treatment of Prader-Willi syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/383369/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161688-public-summary-opinion-orphan-designation-setmelanotide-treatment-prader-willi-syndrome_en.pdf"},
    {"id":"31789","name":"EU/3/12/1046: Public summary of opinion on orphan designation: Mavoglurant for treatment of fragile-X syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T17:00:00Z","last_updated_date":"2015-02-10T17:00:00Z","reference_number":"EMA/COMP/613861/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121046-public-summary-opinion-orphan-designation-mavoglurant-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"31790","name":"Summary of changes in the EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) production environment","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-07T18:10:00Z","last_updated_date":"2013-11-07T18:10:00Z","reference_number":"EMA/575783/2013","document_url":"https://www.ema.europa.eu/en/documents/other/summary-changes-eudravigilance-extended-medicinal-product-dictionary-xevmpd-production-environment_en.pdf"},
    {"id":"31791","name":"Public hearing on 13 June 2018 - Citizens to be consulted on quinolone and fluoroquinolone antibiotics","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-04-09T02:00:00Z","last_updated_date":"2018-04-09T02:00:00Z","reference_number":"EMA/192201/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/public-hearing-13-june-2018-citizens-be-consulted-quinolone-and-fluoroquinolone-antibiotics_en.pdf"},
    {"id":"31792","name":"Presentation - Medicines shortages issues and recent actions: Eurordis perspective (Franà§ois Houà¿ez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-shortages-issues-and-recent-actions-eurordis-perspective-franassois-houaez_en.pdf"},
    {"id":"31797","name":"COMP meeting report on the review of applications for orphan designation: February 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-02-27T17:05:00Z","last_updated_date":"2017-02-27T17:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-february-2017_en.pdf"},
    {"id":"31802","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 19-22 January 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-02-02T16:30:00Z","last_updated_date":"2015-02-02T16:30:00Z","reference_number":"EMA/27848/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-19-22-january-2015_en.pdf"},
    {"id":"31803","name":"Diltiazem: List of nationally authorised medicinal products - PSUSA/00001084/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-17T17:04:00Z","last_updated_date":"2018-01-17T17:09:57Z","reference_number":"EMA/10900/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/diltiazem-list-nationally-authorised-medicinal-products-psusa00001084201705_en.pdf"},
    {"id":"31804","name":"European Medicines Agency 2013 priorities for drug safety research: DNA collection and studies on the genetic causes of adverse drug reactions: angiotensin-converting-enzyme-inhibitor-related angioedema and statin-induce...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-22T18:13:30Z","last_updated_date":"2012-05-22T18:13:30Z","reference_number":"EMA/281421/2012","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-2013-priorities-drug-safety-research-dna-collection-and-studies-genetic-causes-adverse-drug-reactions-angiotensin-converting-enzyme-inhibitor-related-angioedema-and-statin_en.pdf"},
    {"id":"31806","name":"EU/3/03/179: Public summary of positive opinion for orphan designation of recombinant human factor XIII (composed of two A subunits) for the treatment of hereditary factor-XIII deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2014-01-13T01:00:00Z","reference_number":"EMA/COMP/1590/2003, Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303179-public-summary-positive-opinion-orphan-designation-recombinant-human-factor-xiii-composed-two-subunits-treatment-hereditary-factor-xiii-deficiency_en.pdf"},
    {"id":"31808","name":"Final public statement on Sambucus nigra L., fructus","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T02:00:00Z","last_updated_date":"2014-04-29T02:00:00Z","reference_number":"EMA/HMPC/32465/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/final-public-statement-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"31809","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Sambucus nigra L., flos - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"EMA/HMPC/195730/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-sambucus-nigra-l-flos-revision-1_en.pdf"},
    {"id":"31816","name":"ICH: E 1: Population exposure: The extent of population exposure to assess clinical safety - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1995-06-01T02:00:00Z","last_updated_date":"1995-06-01T02:00:00Z","reference_number":"CPMP/ICH/375/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-1-population-exposure-extent-population-exposure-assess-clinical-safety-step-5_en.pdf"},
    {"id":"31818","name":"Superseded overview of comments received on public statement on Centella asiatica (L.) Urban, herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2022-09-02T17:50:00Z","last_updated_date":"2022-09-02T17:50:00Z","reference_number":"EMA/HMPC/573720/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-public-statement-centella-asiatica-l-urban-herba_en.pdf"},
    {"id":"31819","name":"Draft community herbal monograph on Juniperus communis L., pseudo-fructus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-01-14T01:00:00Z","last_updated_date":"2009-01-14T01:00:00Z","reference_number":"EMEA/HMPC/441929/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-juniperus-communis-l-pseudo-fructus_en.pdf"},
    {"id":"31820","name":"Ergot derivatives Article-31 referral - Dihydroergocryptine - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocryptine-annex-iii_sv.pdf"}},
    {"id":"31821","name":"CHMP statistics: October 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-13T02:00:00Z","last_updated_date":"2017-10-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-october-2017_en.pdf"},
    {"id":"31822","name":"Committee for veterinary medicinal products: 38th meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-12-11T00:09:21Z","last_updated_date":"1998-12-11T00:09:21Z","reference_number":"EMEA/CVMP/622/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-38th-meeting_en.pdf"},
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    {"id":"31826","name":"EU/3/14/1393: Public summary of positive opinion for orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor for the treatment of diffuse lar...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/736525/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141393-public-summary-positive-opinion-orphan-designation-autologous-t-cells-transduced-retroviral-vector-encoding-anti-cd19-cd28cd3-zeta-chimeric-antigen-receptor-treatment-diffuse-lar_en.pdf"},
    {"id":"31827","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-09T01:00:00Z","last_updated_date":"2017-11-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course_en.pdf-1"},
    {"id":"31828","name":"Draft reflection paper on the demonstration of a possible impact of maternally derived antibodies on vaccine efficacy in young animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-03-16T01:00:00Z","last_updated_date":"2009-03-16T01:00:00Z","reference_number":"EMEA/CVMP/IWP/439467/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-demonstration-possible-impact-maternally-derived-antibodies-vaccine-efficacy-young-animals_en.pdf"},
    {"id":"31829","name":"Presentation - Efficacy and effectiveness models","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-efficacy-and-effectiveness-models_en.pdf"},
    {"id":"31831","name":"Work plan for the Gene Therapy Working Party 2012","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2010-12-02T00:09:21Z","last_updated_date":"2012-01-23T12:11:00Z","reference_number":"EMA/CAT/GTWP/574590/2010","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-gene-therapy-working-party-2012_en.pdf"},
    {"id":"31832","name":"Metoclopramide Article-31 referral - European Medicines Agency confirms changes to the use of metoclopramide","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T12:00:00Z","last_updated_date":"2014-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metoclopramide-article-31-referral-european-medicines-agency-confirms-changes-use-metoclopramide_sv.pdf"}},
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    {"id":"31837","name":"Gadoteric acid (IV and intravascular formulations): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001506/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T01:00:00Z","last_updated_date":"2016-10-19T12:37:31Z","reference_number":"EMA/194350/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteric-acid-iv-and-intravascular-formulations-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001506201504_en.pdf"},
    {"id":"31838","name":"Zanamivir: List of nationally authorised medicinal products - PSUSA/00003141/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-29T17:55:00Z","last_updated_date":"2017-09-29T17:56:31Z","reference_number":"EMA/639167/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/zanamivir-list-nationally-authorised-medicinal-products-psusa00003141201701_en.pdf"},
    {"id":"31839","name":"Ketoconazole Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-06-13T02:00:00Z","last_updated_date":"2014-06-13T02:00:00Z","reference_number":"EMA/CHMP/580489/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoconazole-article-31-referral-assessment-report_en.pdf"},
    {"id":"31840","name":"Template for a European Union list entry","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2008-03-07T00:09:00Z","last_updated_date":"2020-07-29T15:30:00Z","reference_number":"EMA/HMPC/439705/2006 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-european-union-list-entry_en.pdf"},
    {"id":"31842","name":"CHMP post-authorisation summary of positive opinion for Galvus","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-12-16T16:43:00Z","last_updated_date":"2011-12-16T16:43:00Z","reference_number":"EMA/CHMP/966346/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-galvus_en.pdf-0"},
    {"id":"31844","name":"Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-11T18:00:00Z","last_updated_date":"2018-09-11T18:05:30Z","reference_number":"EMA/613960/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproheptadine-list-nationally-authorised-medicinal-products-psusa00000902201712_en.pdf"},
    {"id":"31845","name":"Oxynal, Targin Article-13 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-27T17:15:00Z","last_updated_date":"2015-01-27T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/oxynal-targin-article-13-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/oxynal-targin-article-13-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/oxynal-targin-article-13-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/oxynal-targin-article-13-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/oxynal-targin-article-13-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/oxynal-targin-article-13-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/oxynal-targin-article-13-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/oxynal-targin-article-13-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/oxynal-targin-article-13-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/oxynal-targin-article-13-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/oxynal-targin-article-13-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/oxynal-targin-article-13-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/oxynal-targin-article-13-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/oxynal-targin-article-13-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/oxynal-targin-article-13-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/oxynal-targin-article-13-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/oxynal-targin-article-13-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/oxynal-targin-article-13-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/oxynal-targin-article-13-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/oxynal-targin-article-13-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/oxynal-targin-article-13-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/oxynal-targin-article-13-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/oxynal-targin-article-13-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/oxynal-targin-article-13-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/oxynal-targin-article-13-referral-annex-i_no.pdf"}},
    {"id":"31847","name":"GlaxoSmithKline withdraws its application for an extension of the indication for Tyverb (lapatinib)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T15:00:00Z","last_updated_date":"2012-02-16T15:00:00Z","reference_number":"EMA/121832/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/glaxosmithkline-withdraws-its-application-extension-indication-tyverb-lapatinib_en.pdf"},
    {"id":"31849","name":"EudraVigilance stakeholder change management plan","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-10-27T01:00:00Z","last_updated_date":"2017-11-22T10:30:00Z","reference_number":"EMA/325783/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-stakeholder-change-management-plan_en.pdf"},
    {"id":"31850","name":"EU/3/17/1899: Public summary of opinion on orphan designation: Antisense oligonucleotide targeting exon 13 in the USH2A gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/508063/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171899-public-summary-opinion-orphan-designation-antisense-oligonucleotide-targeting-exon-13-ush2a-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"31851","name":"Zolpidem Article-31 - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-04T12:00:00Z","last_updated_date":"2014-08-04T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zolpidem-article-31-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zolpidem-article-31-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zolpidem-article-31-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zolpidem-article-31-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zolpidem-article-31-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zolpidem-article-31-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zolpidem-article-31-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zolpidem-article-31-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zolpidem-article-31-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zolpidem-article-31-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zolpidem-article-31-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zolpidem-article-31-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zolpidem-article-31-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zolpidem-article-31-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zolpidem-article-31-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zolpidem-article-31-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zolpidem-article-31-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zolpidem-article-31-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zolpidem-article-31-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zolpidem-article-31-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zolpidem-article-31-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zolpidem-article-31-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zolpidem-article-31-annex-ii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/zolpidem-article-31-annex-ii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/zolpidem-article-31-annex-ii_no.pdf"}},
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    {"id":"31857","name":"EMA Technical Anonymisation Group (TAG) - Terms of reference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T15:15:00Z","last_updated_date":"2017-10-31T15:15:00Z","reference_number":"EMA/708101/2017","document_url":"https://www.ema.europa.eu/en/documents/other/ema-technical-anonymisation-group-tag-terms-reference_en.pdf"},
    {"id":"31859","name":"Agenda - 2012 European Union Good Clinical Practice Inspectors Working Group workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-11-12T13:00:00Z","last_updated_date":"2012-11-12T13:00:00Z","reference_number":"EMA/INS/GCP/720678/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2012-european-union-good-clinical-practice-inspectors-working-group-workshop_en.pdf"},
    {"id":"31860","name":"Research in newborn infants. Ethical aspects, recruitment and informed consent - Pieter J.J. Sauer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-11T02:09:21Z","last_updated_date":"2006-10-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/research-newborn-infants-ethical-aspects-recruitment-and-informed-consent-pieter-jj-sauer_en.pdf"},
    {"id":"31862","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-05-13T16:20:00Z","last_updated_date":"2014-05-13T16:20:00Z","reference_number":"EMA/242696/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-april-2014_en.pdf"},
    {"id":"31865","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T01:00:00Z","last_updated_date":"2023-01-23T08:48:00Z","reference_number":"EMA/136148/2012 Rev. 64","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-substances_en.xlsx"},
    {"id":"31866","name":"EMEA announces appointment of new Head of Unit for Human Medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-03-01T01:00:00Z","last_updated_date":"2001-03-01T01:00:00Z","reference_number":"EMEA/D/5796/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-announces-appointment-new-head-unit-human-medicines_en.pdf"},
    {"id":"31867","name":"Presentation - Considerations on regulatory aspects (Zigmars Sebris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-considerations-regulatory-aspects-zigmars-sebris_en.pdf"},
    {"id":"31871","name":"Cilastatin / Imipenem: List of nationally authorised medicinal products - PSUSA/00000748/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T16:30:00Z","last_updated_date":"2018-02-13T16:30:00Z","reference_number":"EMA/88494/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cilastatin-imipenem-list-nationally-authorised-medicinal-products-psusa00000748201706_en.pdf"},
    {"id":"31875","name":"Template - Framework for a correlation table (notice to applicants: Common Technical Document (CTD)) for active-substance master files / part 2 in CTD format for dossiers for veterinary medicinal products","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-22T15:30:00Z","last_updated_date":"2012-05-22T15:30:00Z","reference_number":"EMA/115282/2012","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-framework-correlation-table-notice-applicants-common-technical-document-ctd-active-substance-master-files-part-2-ctd-format-dossiers-veterinary-medicinal-products_en.pdf"},
    {"id":"31876","name":"Overview of comments received on  the guideline - EMEA/CHMP working group with Healthcare Professionals' Organisations (HCP WG) - Final recommendations and proposals for action","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-02-06T00:09:21Z","last_updated_date":"2009-02-06T00:09:21Z","reference_number":"EMEA/536569/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-guideline-emeachmp-working-group-healthcare-professionals-organisations-hcp-wg-final-recommendations-and-proposals-action_en.pdf"},
    {"id":"31878","name":"Presentation - Pre-clinical requirements to support development of paediatric medicines (Janina Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T18:12:00Z","last_updated_date":"2016-10-26T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pre-clinical-requirements-support-development-paediatric-medicines-janina-karres_en.pdf"},
    {"id":"31879","name":"Tildipirosin\n\nEuropean public MRL assessment report (EPMAR)\n\nCommittee for Medicinal Products for Veterinary Use","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/CVMP/709377/2009","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tildipirosin-european-public-mrl-assessment-report-epmar-committee-medicinal-products-veterinary-use_en.pdf"},
    {"id":"31880","name":"Guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-05-30T15:00:00Z","last_updated_date":"2013-05-30T15:00:00Z","reference_number":"EMA/CHMP/185423/2010 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-depression-revision-2_en.pdf"},
    {"id":"31881","name":"Annex 3 Response Questionnaire - Financial - EMA-2012-09-IF","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"EMA/687094/2011","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-3-response-questionnaire-financial-ema-2012-09-if_en.xls"},
    {"id":"31882","name":"The European Union and the FDA working together to create Common Application for Orphan Designation for Medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-26T01:00:00Z","last_updated_date":"2007-11-26T01:00:00Z","reference_number":"EMEA/557391/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-union-and-fda-working-together-create-common-application-orphan-designation-medicines_en.pdf"},
    {"id":"31884","name":"Draft assessment report on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium and fructus – Revision 1","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2017-10-12T02:00:00Z","last_updated_date":"2017-10-12T02:00:00Z","reference_number":"EMA/HMPC/228759/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-senna-alexandrina-mill-cassia-senna-l-cassia-angustifolia-vahl-folium-and-fructus-revision-1_en.pdf"},
    {"id":"31887","name":"Presentation - Modelling and simulation in preclinical development: Predicting thyroid hormone side effects in humans from preclinical toxicity studies - Break-out session 1 theme 1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-30T12:45:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-preclinical-development-predicting-thyroid-hormone-side-effects-humans-preclinical-toxicity-studies-break-out-session-1-theme-1_en.pdf"},
    {"id":"31889","name":"Risk management plan  (RMP) assessment report sub-template for type II variations and  periodic safety update reports (PSURs)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T15:00:00Z","last_updated_date":"2018-09-18T17:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/risk-management-plan-rmp-assessment-report-sub-template-type-ii-variations-and-periodic-safety-update-reports-psurs_en.docx"},
    {"id":"31890","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - Amended review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-15T14:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/267042/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-amended-review-started_en.pdf"},
    {"id":"31892","name":"EU/3/14/1313: Public summary of opinion on orphan designation: (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/COMP/433740/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141313-public-summary-opinion-orphan-designation-z-3-3-35-bistrifluoromethylphenyl-1h-124-triazol-1-yl-n-pyrazin-2-ylacrylohydrazide-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"31893","name":"Diclazuril (extension to poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-05T10:05:00Z","last_updated_date":"2013-03-05T10:05:00Z","reference_number":"EMA/CVMP/165950/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diclazuril-extension-poultry-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"31894","name":"European Medicines Agency strategy paper: Acceptance of clinical trials conducted in third  countries, for evaluation in marketing-authorisation applications","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-12-05T00:09:21Z","last_updated_date":"2008-12-05T00:09:21Z","reference_number":"EMEA/228067/2008","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-strategy-paper-acceptance-clinical-trials-conducted-third-countries-evaluation-marketing-authorisation-applications_en.pdf"},
    {"id":"31898","name":"Presentation - PIP session: Paediatric uveitis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pip-session-paediatric-uveitis_en.pdf"},
    {"id":"31899","name":"European Medicines Agency mid-year report 2014 from the Executive Director","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-10-08T15:00:00Z","last_updated_date":"2014-10-08T15:00:00Z","reference_number":"EMA/620653/2014","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-mid-year-report-2014-executive-director_en.pdf"},
    {"id":"31900","name":"Working party on Herbal Medicinal Products: Draft proposal for a core data for Melissa leaf","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2000-03-31T02:00:00Z","last_updated_date":"2000-03-31T02:00:00Z","reference_number":"EMEA/HMPWP/19/00","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-draft-proposal-core-data-melissa-leaf_en.pdf"},
    {"id":"31901","name":"Withdrawal letter: Tigecycline Accord","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T14:00:00Z","last_updated_date":"2017-09-15T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-tigecycline-accord_en.pdf"},
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    {"id":"31906","name":"EU/3/01/084: Public summary of positive opinion for orphan designation ofazacitidine for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2019-02-20T02:00:00Z","reference_number":"EMA/COMP/89/2002 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301084-public-summary-positive-opinion-orphan-designation-ofazacitidine-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"31907","name":"Presentation - A European common data model? Why? Which and how? - meeting objectives (Alison Cave)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-common-data-model-why-which-and-how-meeting-objectives-alison-cave_en.pdf"},
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    {"id":"31914","name":"European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T18:00:00Z","last_updated_date":"2012-02-22T12:20:00Z","reference_number":"EMA/CHMP/119670/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-final-recommendations-12-centrally-authorised-medicines-manufactured-ben-venue-laboratories_en.pdf"},
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    {"id":"31924","name":"Draft guideline on core SPC for human plasma fibrinogen products\n\n(EMEA/CHMP/BPWP/122007/2005)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-01-25T01:00:00Z","last_updated_date":"2007-01-25T01:00:00Z","reference_number":"EMEA/CHMP/BPWP/122007/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-spc-human-plasma-fibrinogen-products-emeachmpbpwp1220072005_en.pdf"},
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    {"id":"31934","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 19-22 January 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T13:00:00Z","last_updated_date":"2015-01-23T13:00:00Z","reference_number":"EMA/CHMP/SAWP/54035/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-19-22-january-2015_en.pdf"},
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    {"id":"31937","name":"Suggestion by the Agency on collating data on use of veterinary AM agents in Europe (ESVAC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/suggestion-agency-collating-data-use-veterinary-am-agents-europe-esvac_en.pdf"},
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    {"id":"31941","name":"Draft list of references supporting the assessment of Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria x ananassa (Weston) Duchesne ex Rozier, folium - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2018-04-11T12:30:00Z","last_updated_date":"2018-04-11T12:30:00Z","reference_number":"EMA/HMPC/432277/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-fragaria-vesca-l-fragaria-moschata-weston-fragaria-viridis-weston-and-fragaria-x-ananassa-weston-duchesne-ex-rozier-folium-first-version_en.pdf"},
    {"id":"31942","name":"Opinion following an Article 29(4) referral for Ciprofloxacin Hikma and associated names International Non-Proprietary Name (INN): Ciprofloxacin: Background 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    {"id":"31945","name":"CVMP summary of positive opinion for Zuprevo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/CVMP/91406/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-zuprevo_en.pdf"},
    {"id":"31946","name":"Methylprednisolone: List of nationally authorised medicinal products - PSUSA/00002026/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T01:00:00Z","last_updated_date":"2016-10-18T11:46:17Z","reference_number":"EMA/749746/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylprednisolone-list-nationally-authorised-medicinal-products-psusa00002026201411_en.pdf"},
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    {"id":"31952","name":"Presentation - Signal management GVP IX: pilot on signals from MAHs (A. Szmigiel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T15:08:00Z","last_updated_date":"2018-01-04T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-signal-management-gvp-ix-pilot-signals-mahs-szmigiel_en.pdf"},
    {"id":"31954","name":"General Concepts in the European Pharmacopoeia - Anne-Sophie Bouin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/general-concepts-european-pharmacopoeia-anne-sophie-bouin_en.pdf"},
    {"id":"31955","name":"Committee for Medicinal Products for Human Use (CHMP) - September 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-10-01T02:00:00Z","last_updated_date":"2010-10-01T02:00:00Z","reference_number":"EMA/CHMP/601293/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-september-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"31958","name":"Declaration of interest: Richard Vesely","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-26T02:00:00Z","last_updated_date":"2019-10-25T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interest-richard-vesely_en.pdf"},
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    {"id":"31960","name":"3,5-Diiodo-L-thyrosine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/320/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/35-diiodo-l-thyrosine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"32020","name":"PDCO meeting highlights 4-6 August 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-08-16T02:00:00Z","last_updated_date":"2010-08-16T02:00:00Z","reference_number":"EMA/PDCO/495373/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-4-6-august-2010_en.pdf"},
    {"id":"32021","name":"Presentation - Dose selection in drug development and regulation: possible future direction (Richard Lalonde, Donald Stanski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dose-selection-drug-development-and-regulation-possible-future-direction-richard-lalonde-donald-stanski_en.pdf"},
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    {"id":"32044","name":"Technical specification - Annex 7 Lot 1 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-7-lot-1-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"32045","name":"Template to be used to notify the European Medicines Agency and concerned Member States of 'withdrawn products'","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-10-31T15:00:00Z","last_updated_date":"2022-03-21T08:41:00Z","reference_number":"EMA/445787/2013 Rev.4 Corr.","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-be-used-notify-european-medicines-agency-and-concerned-member-states-withdrawn-products_en.xlsx"},
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    {"id":"32050","name":"Kantos Master Article-13 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-05-02T12:00:00Z","last_updated_date":"2013-05-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kantos-master-article-13-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kantos-master-article-13-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kantos-master-article-13-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kantos-master-article-13-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kantos-master-article-13-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kantos-master-article-13-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kantos-master-article-13-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kantos-master-article-13-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kantos-master-article-13-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kantos-master-article-13-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kantos-master-article-13-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kantos-master-article-13-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kantos-master-article-13-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kantos-master-article-13-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kantos-master-article-13-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kantos-master-article-13-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kantos-master-article-13-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kantos-master-article-13-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kantos-master-article-13-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kantos-master-article-13-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kantos-master-article-13-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kantos-master-article-13-referral-annex-ii_sv.pdf"}},
    {"id":"32051","name":"EU/3/13/1130: Public summary of opinion on orphan designation: Recombinant human transglutaminase 1 encapsulated into liposomes for the treatment of transglutaminase-1-deficient autosomal recessive congenital ichthyosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-06-25T19:00:00Z","reference_number":"EMA/COMP/273194/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131130-public-summary-opinion-orphan-designation-recombinant-human-transglutaminase-1-encapsulated-liposomes-treatment-transglutaminase-1-deficient-autosomal-recessive-congenital-ichthyosis_en.pdf"},
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    {"id":"32055","name":"Committee on Advanced Therapies (CAT) celebrates its first birthday","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-27T00:09:21Z","last_updated_date":"2010-01-27T00:09:21Z","reference_number":"EMA/25684/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-advanced-therapies-cat-celebrates-its-first-birthday_en.pdf"},
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    {"id":"32060","name":"EU/3/06/360: Public summary of positive opinion for orphan designation of ciclosporin for the treatment of vernal keratoconjunctivitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T00:00:00Z","last_updated_date":"2015-05-14T01:00:00Z","reference_number":"EMEA/COMP/107514/2006 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306360-public-summary-positive-opinion-orphan-designation-ciclosporin-treatment-vernal-keratoconjunctivitis_en.pdf"},
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    {"id":"32067","name":"Questions and answers on the referral for Trimetadizine-ratiopharm trimetazidine 35 mg modified-release tablets","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-01-23T00:59:00Z","last_updated_date":"2009-01-23T00:59:00Z","reference_number":"EMEA/45404/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-trimetadizine-ratiopharm-trimetazidine-35-mg-modified-release-tablets_en.pdf"},
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    {"id":"32070","name":"Haemophilus type b conjugate vaccines :  List of nationally authorised medicinal products - PSUSA/00001584/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-23T17:24:00Z","last_updated_date":"2017-11-23T17:36:22Z","reference_number":"EMA/691535/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/haemophilus-type-b-conjugate-vaccines-list-nationally-authorised-medicinal-products-psusa00001584201702_en.pdf"},
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    {"id":"32077","name":"Ondansetron: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation -  PSUSA/00002217/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-08T01:00:00Z","last_updated_date":"2016-10-18T13:02:18Z","reference_number":"EMA/829758/215","document_url":"https://www.ema.europa.eu/en/documents/psusa/ondansetron-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002217201502_en.pdf"},
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    {"id":"32115","name":"EU/3/12/1065: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against claudin-5 complexed with polyethyleneimine (prior to administration of doxorubicin) for the ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"EMA/COMP/678670/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121065-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-claudin-5-complexed-polyethyleneimine-prior-administration-doxorubicin_en.pdf"},
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    {"id":"32138","name":"Medicines granted a Community marketing authorisation under the centralised procedure from 01 January to 31 January 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T13:00:00Z","last_updated_date":"2012-02-17T13:00:00Z","reference_number":"EMA/124722/2012","document_url":"https://www.ema.europa.eu/en/documents/other/medicines-granted-community-marketing-authorisation-under-centralised-procedure-01-january-31-january-2012_en.pdf"},
    {"id":"32139","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the October 2009 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-10-13T02:09:21Z","last_updated_date":"2009-10-13T02:09:21Z","reference_number":"EMEA/COMP/617218/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-october-2009-meeting_en.pdf"},
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    {"id":"32150","name":"Cimicifugae racemosae rhizoma: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-05-01T02:00:00Z","last_updated_date":"1999-05-01T02:00:00Z","reference_number":"EMEA/MRL/563/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cimicifugae-racemosae-rhizoma-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32151","name":"EU/3/12/1008: Public summary of opinion on orphan designation: Human erythrocytes encapsulating inositol hexaphosphate for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2012-07-24T16:00:00Z","reference_number":"EMA/COMP/350652/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121008-public-summary-opinion-orphan-designation-human-erythrocytes-encapsulating-inositol-hexaphosphate-treatment-sickle-cell-disease_en.pdf"},
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    {"id":"32159","name":"EU/3/15/1498: Public summary of opinion on orphan designation: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl) acetamide for treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2020-04-16T02:00:00Z","reference_number":"EMA/COMP/274375/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151498-public-summary-opinion-orphan-designation-2-7-ethoxy-4-3-fluorophenyl-1-oxophthalazin-21h-yl-n-methyl-n-2-methylbenzodoxazol-6-yl-acetamide-treatment-cystic-fibrosis_en.pdf"},
    {"id":"32161","name":"Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Lumiracoxib, Parecoxib, and Valdecoxib International Non-Proprietary Name (INN): celecoxib: Background 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    {"id":"32170","name":"Overview of comments received on European Union herbal monograph on Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus (EMA/HMPC/674139/2013)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/HMPC/41015/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus-emahmpc6741392013_en.pdf"},
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    {"id":"32175","name":"Linoladiol N and Linoladiol HN Article-31 referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-11T02:00:00Z","last_updated_date":"2014-09-11T02:00:00Z","reference_number":"EMA/281995/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/linoladiol-n-and-linoladiol-hn-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"32178","name":"Manganese compounds: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-12-01T01:00:00Z","last_updated_date":"1997-12-01T01:00:00Z","reference_number":"EMEA/MRL/334/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/manganese-compounds-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32181","name":"Numeta Article-107i procedure - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-27T15:00:00Z","last_updated_date":"2013-09-27T15:00:00Z","reference_number":"EMEA/H/A-107i/1373","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/numeta-article-107i-procedure-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/numeta-article-107i-procedure-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/numeta-article-107i-procedure-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/numeta-article-107i-procedure-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/numeta-article-107i-procedure-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/numeta-article-107i-procedure-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/numeta-article-107i-procedure-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/numeta-article-107i-procedure-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/numeta-article-107i-procedure-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/numeta-article-107i-procedure-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/numeta-article-107i-procedure-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/numeta-article-107i-procedure-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/numeta-article-107i-procedure-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/numeta-article-107i-procedure-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/numeta-article-107i-procedure-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/numeta-article-107i-procedure-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/numeta-article-107i-procedure-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/numeta-article-107i-procedure-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/numeta-article-107i-procedure-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/numeta-article-107i-procedure-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/numeta-article-107i-procedure-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/numeta-article-107i-procedure-annex-i_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/numeta-article-107i-procedure-annex-i_no.pdf"}},
    {"id":"32183","name":"CHMP summary of positive opinion for Iasibon","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/643636/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-iasibon_en.pdf"},
    {"id":"32186","name":"Addendum no. 1 to the cooperation between the Pharmaceutical Inspection Cooperation Scheme and the European Medicines Agency of 28 December 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-11T17:30:00Z","last_updated_date":"2012-07-11T17:30:00Z","reference_number":"EMA/352642/2012","document_url":"https://www.ema.europa.eu/en/documents/other/addendum-no-1-cooperation-between-pharmaceutical-inspection-cooperation-scheme-and-european-medicines-agency-28-december-2010_en.pdf"},
    {"id":"32187","name":"Presentation - Session 2 – ISO ICSR Implementation technical aspects - Part 1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-12T12:30:00Z","last_updated_date":"2016-05-12T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-iso-icsr-implementation-technical-aspects-part-1_en.pdf"},
    {"id":"32188","name":"Final assessment report on Marrubium vulgare L., herba - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T17:00:00Z","last_updated_date":"2013-08-01T17:00:00Z","reference_number":"EMA/HMPC/604273/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-marrubium-vulgare-l-herba-first-version_en.pdf"},
    {"id":"32189","name":"Withdrawal letter : Kexxtone","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-04-22T02:00:00Z","last_updated_date":"2009-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-kexxtone_en.pdf"},
    {"id":"32190","name":"Final assessment report on Taraxacum officinale Weber ex Wigg., radix cum herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/HMPC/212897/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf"},
    {"id":"32191","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 12-15 September 2005","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-09-15T02:00:00Z","last_updated_date":"2005-09-15T02:00:00Z","reference_number":"EMEA/303099/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-12-15-september-2005_en.pdf"},
    {"id":"32192","name":"CHMP summary of positive opinion for Refixia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"EMA/CHMP/193129/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-refixia_en.pdf"},
    {"id":"32193","name":"Presentation - PKD presentation of outcomes: Consortium / European Medicines Agency Scientific Advice Working Party teleconference (Third list of issues)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-22T11:00:00Z","last_updated_date":"2015-07-22T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pkd-presentation-outcomes-consortium-european-medicines-agency-scientific-advice-working-party-teleconference-third-list-issues_en.pdf"},
    {"id":"32195","name":"Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-06T19:08:00Z","last_updated_date":"2018-12-20T14:00:00Z","reference_number":"EMA/INS/GMP/129953/2012","document_url":"https://www.ema.europa.eu/en/documents/other/programme-rationalise-international-good-manufacturing-practice-inspections-active-pharmaceutical-ingredient-active-substance-manufacturers-terms-reference-and-procedures-participating-authorities_en.pdf"},
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    {"id":"32198","name":"EU/3/07/505: Public summary of positive opinion of acute respiratory distress syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2018-10-11T09:43:00Z","reference_number":"EMA/396437/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307505-public-summary-positive-opinion-acute-respiratory-distress-syndrome_en.pdf"},
    {"id":"32199","name":"Testosterone (all formulations apart from topical use and testosterone undecanoate injection): List of nationally authorised medicinal products - PSUSA/00002907/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-07T16:30:00Z","last_updated_date":"2016-11-21T10:52:09Z","reference_number":"EMA/730861/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/testosterone-all-formulations-apart-topical-use-and-testosterone-undecanoate-injection-list-nationally-authorised-medicinal-products-psusa00002907201512_en.pdf"},
    {"id":"32200","name":"Presentation - e-Submission roadmap: Veterinary perspective (Anne-Christine Lantin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-e-submission-roadmap-veterinary-perspective-anne-christine-lantin_en.pdf"},
    {"id":"32201","name":"European Medicines Agency agrees on action plan following the recall of Viracept and recommends suspension of the Marketing Authorisation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-21T02:00:00Z","last_updated_date":"2007-06-21T02:00:00Z","reference_number":"EMEA/275367/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-agrees-action-plan-following-recall-viracept-and-recommends-suspension-marketing-authorisation_en.pdf"},
    {"id":"32204","name":"Committee for medicinal products for human use, summary of positive opinion for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/366446/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-prepandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-biologicals_en.pdf"},
    {"id":"32206","name":"CHMP summary of opinion for Pemetrexed Actavis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"EMA/CHMP/675005/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-pemetrexed-actavis_en.pdf"},
    {"id":"32209","name":"Quetiapine: List of nationally authorised medicinal products -      PSUSA/00002589/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-04T13:25:00Z","last_updated_date":"2018-06-15T16:40:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/quetiapine-list-nationally-authorised-medicinal-products-psusa00002589201707_en.pdf"},
    {"id":"32211","name":"Initial notices for parallel distribution - June 2015","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-07-20T16:35:00Z","last_updated_date":"2015-07-20T16:35:00Z","reference_number":"EMA/461921/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-june-2015_en.pdf"},
    {"id":"32212","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-09T13:27:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"EMA/323287/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf-2"},
    {"id":"32214","name":"Trimethoprim: Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-09-01T02:09:21Z","last_updated_date":"1997-09-01T02:09:21Z","reference_number":"EMEA/MRL/255/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/trimethoprim-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32218","name":"Draft list of references supporting the assessment of Salvia fruticosa Mill., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-12-09T10:00:00Z","last_updated_date":"2015-12-09T10:00:00Z","reference_number":"EMA/HMPC/599993/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-salvia-fruticosa-mill-folium_en.pdf"},
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    {"id":"32230","name":"Final European Union herbal monograph on Valeriana officinalis L., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:30:00Z","last_updated_date":"2017-11-09T13:03:00Z","reference_number":"EMA/HMPC/150848/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"32231","name":"Questions and answers relating to restricted tender procedure EMA/2012/19/IS: Provision of security consultancy services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-29T16:46:00Z","last_updated_date":"2012-11-05T11:54:00Z","reference_number":"EMA/668067/2012","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-relating-restricted-tender-procedure-ema201219is-provision-security-consultancy-services_en.pdf"},
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    {"id":"32233","name":"Fluoxetine: List of nationally authorised medicinal products - PSUSA/00001442/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T20:00:00Z","last_updated_date":"2018-05-23T20:22:18Z","reference_number":"EMA/326378/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluoxetine-list-nationally-authorised-medicinal-products-psusa00001442201709_en.pdf"},
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    {"id":"32241","name":"CHMP summary of positive opinion for Adempas","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-01-24T01:00:00Z","reference_number":"EMA/CHMP/807324/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-adempas_en.pdf"},
    {"id":"32243","name":"C(2005)2034: Public summary of negative opinion for orphan designation of ibuprofen L-lysinate for the prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-11T02:00:00Z","last_updated_date":"2005-10-11T02:00:00Z","reference_number":"EMEA/COMP/130770/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/c20052034-public-summary-negative-opinion-orphan-designation-ibuprofen-l-lysinate-prevention-patent-ductus-arteriosus-premature-neonates-less-34-weeks-gestational-age_en.pdf"},
    {"id":"32244","name":"EU-US mutual recognition of inspections of medicines manufacturers enters operational phase","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T16:09:00Z","last_updated_date":"2017-10-31T16:09:00Z","reference_number":"EMA/662403/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-us-mutual-recognition-inspections-medicines-manufacturers-enters-operational-phase_en.pdf"},
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    {"id":"32251","name":"Presentation - Topic 3 - Obstacles to a timely completion of paediatric development plan studies - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-3-obstacles-timely-completion-paediatric-development-plan-studies-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation_en.pdf"},
    {"id":"32252","name":"Draft assessment report on Eucalyptus globulus Labill., folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2012-06-21T16:01:00Z","last_updated_date":"2012-06-21T16:01:00Z","reference_number":"EMA/HMPC/892615/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-eucalyptus-globulus-labill-folium_en.pdf"},
    {"id":"32254","name":"Final list of references supporting the assessment of Equisetum arvense L. herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-03-17T01:00:00Z","reference_number":"EMA/HMPC/278090/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-equisetum-arvense-l-herba_en.pdf"},
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    {"id":"32262","name":"Haldol Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T19:00:00Z","last_updated_date":"2017-05-05T19:00:00Z","reference_number":"EMA/217986/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/haldol-article-30-referral-assessment-report_en.pdf"},
    {"id":"32263","name":"Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1993-12-01T01:00:00Z","last_updated_date":"1993-12-01T01:00:00Z","reference_number":"3BR3a","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/replacement-chlorofluorocarbons-cfc-metered-dose-inhalation-products_en.pdf"},
    {"id":"32264","name":"CHMP summary of positive opinion for Zoely","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2011-03-18T01:00:00Z","reference_number":"EMA/CHMP/195947/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zoely_en.pdf"},
    {"id":"32269","name":"Procedure on management of proposals submitted by interested parties for Community list entries or Community herbal monographs - Revision 1","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-11-12T01:00:00Z","last_updated_date":"2009-11-12T01:00:00Z","reference_number":"EMEA/HMPC/328575/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-management-proposals-submitted-interested-parties-community-list-entries-or-community-herbal-monographs-revision-1_en.pdf"},
    {"id":"32270","name":"CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - Discussion document","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag4-advice-european-medicines-agency-clinical-trial-advisory-group-good-analysis-practice-discussion-document_en.pdf"},
    {"id":"32272","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 July 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-07-11T18:00:00Z","last_updated_date":"2014-07-11T18:00:00Z","reference_number":"EMA/CVMP/382972/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-july-2014_en.pdf"},
    {"id":"32274","name":"Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Gamithromycin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-01-12T17:52:00Z","last_updated_date":"2017-01-12T17:52:00Z","reference_number":"EMA/CVMP/454065/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits-gamithromycin_en.pdf"},
    {"id":"32275","name":"Trimethoprim: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/trimethoprim-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32276","name":"Presentation - Optimising the use of the EURD list – the key to the single assessment (Menno van der Elst)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-29T01:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optimising-use-eurd-list-key-single-assessment-menno-van-der-elst_en.pdf"},
    {"id":"32278","name":"EU/3/14/1254: Public summary of opinion on orphan designation: Eculizumab for the prevention of graft rejection following solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-06T02:00:00Z","last_updated_date":"2018-05-22T11:31:00Z","reference_number":"EMA/COMP/89171/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141254-public-summary-opinion-orphan-designation-eculizumab-prevention-graft-rejection-following-solid-organ-transplantation_en.pdf"},
    {"id":"32280","name":"CHMP summary of positive opinion for Zessly","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/CHMP/58481/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zessly_en.pdf"},
    {"id":"32281","name":"Committee for Proprietary Medicinal Products (CPMP) 50th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-06-25T02:00:00Z","last_updated_date":"1999-06-25T02:00:00Z","reference_number":"CPMP/1817/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-50th-plenary-meeting_en.pdf"},
    {"id":"32282","name":"Standard operating procedure for preparation, dissemination and publication of safety-related European Medicines Agency press releases and question-and-answer documents","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2011-04-14T02:00:00Z","last_updated_date":"2011-04-14T02:00:00Z","reference_number":"SOP/EMA/0111","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-dissemination-and-publication-safety-related-european-medicines-agency-press-releases-and-question-and-answer-documents_en.pdf"},
    {"id":"32284","name":"Ketoconazole HRA recommended for approval in Cushing's syndrome","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T14:00:04Z","last_updated_date":"2014-09-26T14:00:04Z","reference_number":"EMA/581398/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/ketoconazole-hra-recommended-approval-cushings-syndrome_en.pdf"},
    {"id":"32285","name":"Presentation - Working group on ethics","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-06T01:00:00Z","last_updated_date":"2017-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-ethics_en.pdf"},
    {"id":"32288","name":"Recommendation to restrict the use of Protelos / Osseor (strontium ranelate)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:03Z","last_updated_date":"2013-04-26T14:00:03Z","reference_number":"EMA/258269/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/recommendation-restrict-use-protelos-osseor-strontium-ranelate_en.pdf"},
    {"id":"32289","name":"Presentation - Estimating probability of target attainment (Johan Mouton)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-estimating-probability-target-attainment-johan-mouton_en.pdf"},
    {"id":"32293","name":"List of species and breeds for electronic reporting of suspected adverse reactions in veterinary pharmacovigilance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-08-22T02:00:00Z","last_updated_date":"2011-06-30T02:00:00Z","reference_number":"EMEA/CVMP/553/03 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/list-species-and-breeds-electronic-reporting-suspected-adverse-reactions-veterinary-pharmacovigilance_en.pdf"},
    {"id":"32295","name":"CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 4 April 2013 version 8.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-advice-european-medicines-agency-rules-engagement-accessing-clinical-trial-data-draft-4-april-2013-version-80_en.pdf"},
    {"id":"32299","name":"Engagement framework: European Medicines Agency and patients, consumers and their organisations","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-02-14T01:00:00Z","last_updated_date":"2022-02-07T16:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/engagement-framework-european-medicines-agency-and-patients-consumers-and-their-organisations_en.pdf"},
    {"id":"32301","name":"Clopidogrel Teva - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-09-08T02:00:00Z","last_updated_date":"2011-09-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/clopidogrel-teva-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"32302","name":"EU/3/13/1205: Public summary of opinion on orphan designation: Human monoclonal antibody against human interleukin 13 for the treatment of eosinophilic oesophagitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-12-02T01:00:00Z","last_updated_date":"2022-08-30T11:42:00Z","reference_number":"EMA/COMP/637681/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131205-public-summary-opinion-orphan-designation-human-monoclonal-antibody-against-human-interleukin-13-treatment-eosinophilic-oesophagitis_en.pdf"},
    {"id":"32305","name":"Guideline on similar biological medicinal products containing \n\nBiotechnology-derived proteins as active substance:  Non-clinical and clinical issues","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-02-22T01:00:00Z","last_updated_date":"2006-02-22T01:00:00Z","reference_number":"EMEA/CHMP/BMWP/42832/2005 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues_en.pdf"},
    {"id":"32306","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 18-21 July 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/CHMP/SAWP/508519/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-18-21-july-2016_en.pdf"},
    {"id":"32308","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 11-13 September 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T16:00:00Z","last_updated_date":"2013-11-18T14:00:00Z","reference_number":"EMA/PDCO/556834/2013 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-11-13-september-2013_en.pdf"},
    {"id":"32309","name":"Methylaminolevulinate: List of nationally authorised medicinal products - PSUSA/00002019/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-14T14:30:00Z","last_updated_date":"2018-05-14T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylaminolevulinate-list-nationally-authorised-medicinal-products-psusa00002019201706_en.pdf"},
    {"id":"32310","name":"Questions and answers on the withdrawal of the marketing application for Pristiqs","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-04-04T02:00:00Z","last_updated_date":"2008-04-04T02:00:00Z","reference_number":"EMEA/CHMP/125421/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-pristiqs_en.pdf"},
    {"id":"32311","name":"Firocoxib: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-10-01T02:00:00Z","last_updated_date":"2006-10-01T02:00:00Z","reference_number":"EMEA/CVMP/383063/2006-Final","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/firocoxib-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"32350","name":"Technical specifications - Annex X estimation of ICSRs per annum: Procurement procedure EMA/2014/48/PH","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2014-11-04T10:00:00Z","last_updated_date":"2014-11-04T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-x-estimation-icsrs-annum-procurement-procedure-ema201448ph_en.pdf"},
    {"id":"32351","name":"Mannitol (all indications apart from cystic fibrosis): List of nationally authorised medicinal products - PSUSA/00010005/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-27T17:00:00Z","last_updated_date":"2017-10-27T17:00:00Z","reference_number":"EMA/716838/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/mannitol-all-indications-apart-cystic-fibrosis-list-nationally-authorised-medicinal-products-psusa00010005201702_en.pdf"},
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    {"id":"32355","name":"Opinion following an Article-33(4) referral for Strenzen 500/125-mg/g powder for use in drinking water for pigs and associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-19T02:00:00Z","last_updated_date":"2013-09-19T02:00:00Z","reference_number":"EMA/325274/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-strenzen-500125-mgg-powder-use-drinking-water-pigs-and-associated-names_sv.pdf"}},
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    {"id":"32381","name":"Pre-Qualification Questionnaire (PQQ) for a restricted tender procedure organised by European Medicines Agency (EMEA) corporate travel services EMEA/2008/98/MM&C","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:21Z","last_updated_date":"2008-11-25T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure-organised-european-medicines-agency-emea-corporate-travel-services-emea200898mmc_en.doc"},
    {"id":"32382","name":"Guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-12-11T01:00:00Z","last_updated_date":"2002-12-11T01:00:00Z","reference_number":"EMEA/CVMP/627/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances-first-version_en.pdf"},
    {"id":"32386","name":"CHMP summary of positive opinion for Kengrexal","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2015-01-23T01:00:00Z","reference_number":"EMA/CHMP/45332/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kengrexal_en.pdf"},
    {"id":"32389","name":"Reflection paper on nanotechnology-based medicinal products for human use","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-29T02:09:21Z","last_updated_date":"2006-06-29T02:09:21Z","reference_number":"EMEA/CHMP/79769/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-nanotechnology-based-medicinal-products-human-use_en.pdf"},
    {"id":"32390","name":"Lactose of bovine origin Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-09-04T02:00:00Z","last_updated_date":"2017-09-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lactose-bovine-origin-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"32391","name":"Bromocriptine Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-06T02:00:00Z","last_updated_date":"2014-09-02T17:00:05Z","reference_number":"EMA/PRAC/493206/2013 rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"32392","name":"EU/3/12/1004: Public summary of opinion on orphan designation: Ramucirumab for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2016-01-19T15:00:00Z","reference_number":"EMA/COMP/337338/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121004-public-summary-opinion-orphan-designation-ramucirumab-treatment-gastric-cancer_en.pdf"},
    {"id":"32393","name":"EU/3/08/589: Public summary of positive opinion for orphan designation of yttrium (90Y) edotreotide for the treatment of gastro-entero-pancreatic neuroendocrine tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2018-05-29T02:00:00Z","reference_number":"EMEA/COMP/547022/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308589-public-summary-positive-opinion-orphan-designation-yttrium-90y-edotreotide-treatment-gastro-entero-pancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"32396","name":"HMA/EMA Joint Big Data Task Force","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-23T11:20:00Z","last_updated_date":"2017-03-23T11:20:00Z","reference_number":"EMA/189364/2017","document_url":"https://www.ema.europa.eu/en/documents/other/hmaema-joint-big-data-task-force_en.pdf"},
    {"id":"32398","name":"EU/3/12/1053: Public summary of opinion on orphan designation\n\nLurbinectedin for the treatment of ovarian cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2012-11-16T01:00:00Z","reference_number":"EMA/COMP/624614/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121053-public-summary-opinion-orphan-designation-lurbinectedin-treatment-ovarian-cancer_en.pdf"},
    {"id":"32399","name":"European quality leader of the year 2006 award goes to EMEA staff member","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-06-02T02:00:00Z","last_updated_date":"2006-06-02T02:00:00Z","reference_number":"EMEA/195895/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-quality-leader-year-2006-award-goes-emea-staff-member_en.pdf"},
    {"id":"32400","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Hypericum perforatum L., herba (traditional use)","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2009-12-21T00:09:00Z","last_updated_date":"2023-02-22T00:09:00Z","reference_number":"EMEA/HMPC/752903/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-hypericum-perforatum-l-herba-traditional-use_en.pdf"},
    {"id":"32401","name":"Alendronate: List of nationally authorised medicinal products - PSUSA/00000078/201601","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-13T02:00:00Z","last_updated_date":"2016-10-17T17:40:41Z","reference_number":"EMA/608858/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/alendronate-list-nationally-authorised-medicinal-products-psusa00000078201601_en.pdf"},
    {"id":"32402","name":"Valproate Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valproate-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valproate-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valproate-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valproate-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valproate-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valproate-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valproate-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valproate-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/valproate-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valproate-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valproate-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valproate-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valproate-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valproate-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valproate-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valproate-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valproate-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valproate-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valproate-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valproate-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valproate-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valproate-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/valproate-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/valproate-article-31-referral-annex-i_no.pdf"}},
    {"id":"32403","name":"Baxter dialysis solutions Article-31 referral - Annex IV (US site)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-iv-us-site_sv.pdf"}},
    {"id":"32406","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Glivec","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-11-16T01:00:00Z","last_updated_date":"2006-11-16T01:00:00Z","reference_number":"EMEA/452758/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-glivec_en.pdf"},
    {"id":"32408","name":"CVMP post-authorisation summary of positive opinion for Pexion","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2018-05-28T18:00:00Z","last_updated_date":"2018-05-28T18:00:00Z","reference_number":"EMA/CVMP/293399/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-pexion_en.pdf"},
    {"id":"32409","name":"Standard operation procedure for handling of requests from a national competent authority to the CMDh for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No...","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2013-03-14T11:00:00Z","last_updated_date":"2017-03-02T11:00:00Z","reference_number":"SOP/H/3375","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operation-procedure-handling-requests-national-competent-authority-cmdh-recommendation-classification-unforeseen-variation-under-article-5-commission-regulation-ec-no_en.pdf"},
    {"id":"32410","name":"Agenda - Congress Programme ESDP 2006, 10th Biannual Congress","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2005-12-22T00:09:21Z","last_updated_date":"2005-12-22T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-congress-programme-esdp-2006-10th-biannual-congress_en.pdf"},
    {"id":"32414","name":"Committee for Proprietary Medicinal Products (CPMP) 63rd plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-09-25T02:00:00Z","last_updated_date":"2000-09-25T02:00:00Z","reference_number":"CPMP/2522/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-63rd-plenary-meeting_en.pdf"},
    {"id":"32415","name":"EudraVigilance stakeholder change management plan: integration with the identity and access management (IAM2) project deliverables","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-07-03T19:00:00Z","last_updated_date":"2018-07-03T19:00:00Z","reference_number":"EMA/349760/2018","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-stakeholder-change-management-plan-integration-identity-and-access-management-iam2-project-deliverables_en.pdf"},
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    {"id":"32423","name":"EU/3/14/1428: Public summary of opinion on orphan designation: Sodium valproate for the treatment of Wolfram syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T12:00:00Z","last_updated_date":"2015-03-06T12:00:00Z","reference_number":"EMA/COMP/787361/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141428-public-summary-opinion-orphan-designation-sodium-valproate-treatment-wolfram-syndrome_en.pdf"},
    {"id":"32425","name":"Divergent position on a CVMP opinion on a type II variation to the terms of the marketing authorisation for DRAXXIN (EMEA/V/C/000077/II/0031)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/divergent-position-cvmp-opinion-type-ii-variation-terms-marketing-authorisation-draxxin-emeavc000077ii0031_en.pdf"},
    {"id":"32427","name":"Committee for Proprietary Medicinal Products (CPMP) 14th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-03-14T01:00:00Z","last_updated_date":"1996-03-14T01:00:00Z","reference_number":"CPMP/285/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-14th-plenary-meeting_en.pdf"},
    {"id":"32428","name":"Transparency and commercially confidential information - EGA’s perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/transparency-and-commercially-confidential-information-egas-perspective_en.pdf"},
    {"id":"32430","name":"Agenda - PRAC draft agenda of meeting 4-7 November 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-11-05T19:30:00Z","last_updated_date":"2013-11-06T12:35:00Z","reference_number":"EMA/PRAC/676915/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-4-7-november-2013_en.pdf"},
    {"id":"32433","name":"Ferrer Internacional, S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-06-26T16:58:00Z","last_updated_date":"2012-06-26T16:58:00Z","reference_number":"EMA/431454/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/ferrer-internacional-sa-withdraws-its-marketing-authorisation-application-egrifta-tesamorelin_en.pdf"},
    {"id":"32435","name":"EU/3/03/173: Public summary of positive opinion for orphan designation of vasoactive intestinal peptide for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/1537/03 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303173-public-summary-positive-opinion-orphan-designation-vasoactive-intestinal-peptide-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
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    {"id":"32439","name":"Presentation - Immunologicals (Nikolaus KriŠ¾)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunologicals-nikolaus-kris-34_en.pdf"},
    {"id":"32440","name":"Letter of support for intermediate age related macular degeneration (AMD) biomarker and novel clinical endpoint development","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-02-21T13:10:00Z","last_updated_date":"2018-02-21T13:10:00Z","reference_number":"EMA/72511/2018","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-intermediate-age-related-macular-degeneration-amd-biomarker-and-novel-clinical-endpoint-development_en.pdf"},
    {"id":"32441","name":"EU/3/04/203: Public summary of positive opinion for orphan designation of 5'CTG CCA CGT TCT CCT GC-(2' methoxy)A-(2' methoxy)C-(2'methoxy)C-3' for the treatment of myasthenia gravis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-06T02:00:00Z","last_updated_date":"2019-08-30T14:00:00Z","reference_number":"EMEA/COMP/245/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304203-public-summary-positive-opinion-orphan-designation-5ctg-cca-cgt-tct-cct-gc-2-methoxya-2-methoxyc-2methoxyc-3-treatment-myasthenia-gravis_en.pdf"},
    {"id":"32442","name":"Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T15:50:00Z","last_updated_date":"2014-06-16T14:00:00Z","reference_number":"EMA/227883/2014","document_url":"https://www.ema.europa.eu/en/documents/other/data-quality-control-methodology-data-submitted-under-article-572-regulation-ec-no7262004_en.doc"},
    {"id":"32443","name":"Updated advice on use of high-dose ibuprofen","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/325007/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/updated-advice-use-high-dose-ibuprofen_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/press-release/updated-advice-use-high-dose-ibuprofen_bg.pdf","es":"https://www.ema.europa.eu/es/documents/press-release/updated-advice-use-high-dose-ibuprofen_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/press-release/updated-advice-use-high-dose-ibuprofen_cs.pdf","da":"https://www.ema.europa.eu/da/documents/press-release/updated-advice-use-high-dose-ibuprofen_da.pdf","de":"https://www.ema.europa.eu/de/documents/press-release/updated-advice-use-high-dose-ibuprofen_de.pdf","et":"https://www.ema.europa.eu/et/documents/press-release/updated-advice-use-high-dose-ibuprofen_et.pdf","el":"https://www.ema.europa.eu/el/documents/press-release/updated-advice-use-high-dose-ibuprofen_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/press-release/updated-advice-use-high-dose-ibuprofen_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/press-release/updated-advice-use-high-dose-ibuprofen_hr.pdf","it":"https://www.ema.europa.eu/it/documents/press-release/updated-advice-use-high-dose-ibuprofen_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/press-release/updated-advice-use-high-dose-ibuprofen_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/press-release/updated-advice-use-high-dose-ibuprofen_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/press-release/updated-advice-use-high-dose-ibuprofen_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/press-release/updated-advice-use-high-dose-ibuprofen_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/press-release/updated-advice-use-high-dose-ibuprofen_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/press-release/updated-advice-use-high-dose-ibuprofen_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/press-release/updated-advice-use-high-dose-ibuprofen_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/press-release/updated-advice-use-high-dose-ibuprofen_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/press-release/updated-advice-use-high-dose-ibuprofen_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/press-release/updated-advice-use-high-dose-ibuprofen_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/press-release/updated-advice-use-high-dose-ibuprofen_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/press-release/updated-advice-use-high-dose-ibuprofen_sv.pdf"}},
    {"id":"32444","name":"Questions and answers on the withdrawal of the marketing application for DuoPlavin","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-06-09T02:00:00Z","last_updated_date":"2010-03-31T02:00:00Z","reference_number":"EMEA/279720/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-duoplavin_sv.pdf"}},
    {"id":"32445","name":"Questions and answers on the review of Zerit (stavudine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-02-18T13:27:00Z","last_updated_date":"2011-02-18T13:27:00Z","reference_number":"EMA/127094/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-zerit-stavudine_en.pdf"},
    {"id":"32447","name":"Draft list of references for assessment of: Ribis nigri folium Ribes nigrum L., folium (blackcurrant leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/143130/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-ribis-nigri-folium-ribes-nigrum-l-folium-blackcurrant-leaf_en.pdf"},
    {"id":"32448","name":"Draft list of references supporting the assessment of Sisymbrium officinale (L.) Scop., herba","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-01-17T01:00:00Z","last_updated_date":"2014-01-17T01:00:00Z","reference_number":"EMA/HMPC/280195/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"32449","name":"EU/3/15/1520: Public summary of opinion on orphan designation: Cannabidiol for the treatment of perinatal asphyxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/427063/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151520-public-summary-opinion-orphan-designation-cannabidiol-treatment-perinatal-asphyxia_en.pdf"},
    {"id":"32450","name":"List of participants - Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation, 25 May 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"EMA/289380/2012","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-fifth-stakeholder-forum-implementation-new-pharmacovigilance-legislation-25-may-2012_en.pdf"},
    {"id":"32451","name":"Public statement on ImmunoGam: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2011-01-26T01:00:00Z","last_updated_date":"2011-01-26T01:00:00Z","reference_number":"EMA//CHMP/70300/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-immunogam-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"32452","name":"The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future: Executive Summary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-03-04T01:00:00Z","last_updated_date":"2005-03-04T01:00:00Z","reference_number":"EMEA/H/34163/03/Final","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-road-map-2010-preparing-ground-future-executive-summary_en.pdf"},
    {"id":"32453","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 November 2017","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-11-10T17:00:00Z","last_updated_date":"2017-11-10T17:00:00Z","reference_number":"EMA/CVMP/708873/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-november-2017_en.pdf"},
    {"id":"32454","name":"Call for expression of interest: Access to eXtended Medicinal Product Dictionary (XEVMPD) test environment (XCOMP) for software vendors","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-21T17:20:00Z","last_updated_date":"2014-05-21T17:20:00Z","reference_number":"EMA/220372/2014","document_url":"https://www.ema.europa.eu/en/documents/other/call-expression-interest-access-extended-medicinal-product-dictionary-xevmpd-test-environment-xcomp-software-vendors_en.pdf"},
    {"id":"32456","name":"Mandate of the Coordinating Group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-24T18:48:00Z","last_updated_date":"2020-10-23T16:35:00Z","reference_number":"EMA/149503/2020","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-coordinating-group-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"32458","name":"EU/3/04/244: Public summary of positive opinion for orphan designation of alpha-1 antitrypsin (inhalation use) for the treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2013-02-07T01:00:00Z","reference_number":"EMA/COMP/109743/2004 Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304244-public-summary-positive-opinion-orphan-designation-alpha-1-antitrypsin-inhalation-use-treatment-emphysema-secondary-congenital-alpha-1-antitrypsin-deficiency_en.pdf"},
    {"id":"32459","name":"Withdrawal letter: Aranesp","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aranesp_en.pdf"},
    {"id":"32461","name":"Presentation - ESMO magnitude of clinical benefit scale (ESMO-MCBS)\n\nfor new anticancer therapies (Richard Sullivan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-15T17:00:00Z","last_updated_date":"2015-12-15T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-esmo-magnitude-clinical-benefit-scale-esmo-mcbs-new-anticancer-therapies-richard-sullivan_en.pdf"},
    {"id":"32464","name":"Note of explanation to accompany publication of\n\nreflection paper on formulations of choice for the paediatric population\n\n(EMEA/CHMP/PEG/194810/2005)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-06-23T02:00:00Z","last_updated_date":"2005-06-23T02:00:00Z","reference_number":"EMEA/196218/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-explanation-accompany-publication-reflection-paper-formulations-choice-paediatric-population-emeachmppeg1948102005_en.pdf"},
    {"id":"32465","name":"Agenda - First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-09-25T02:00:00Z","last_updated_date":"2017-09-25T02:00:00Z","reference_number":"EMA/CHMP/SWP/522061/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-ema-workshop-non-animal-approaches-support-medicinal-product-development-challenges-and-opportunities-use-micro-physiological-systems_en.pdf"},
    {"id":"32466","name":"Presentation - Medicines Evaluation Board in the Netherlands: Paediatric formulations (Diana van Riet-Nales)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-evaluation-board-netherlands-paediatric-formulations-diana-van-riet-nales_en.pdf"},
    {"id":"32467","name":"Questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T11:20:00Z","last_updated_date":"2016-06-02T11:20:00Z","reference_number":"EMA/CHMP/SWP/44609/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-guideline-environmental-risk-assessment-medicinal-products-human-use-revision-1_en.pdf"},
    {"id":"32468","name":"Tredaptive, Pelzont and Trevaclyn Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-21T01:00:00Z","last_updated_date":"2012-12-21T01:00:00Z","reference_number":"EMA/PRAC/821161/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/tredaptive-pelzont-and-trevaclyn-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"32469","name":"Presentation - Harmonisation: Vision for the future","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-harmonisation-vision-future_en.pdf"},
    {"id":"32471","name":"Presentation - Public impact of communication (Frederic Bouder)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-impact-communication-frederic-bouder_en.pdf"},
    {"id":"32473","name":"Report to the European Commission on rewards and incentives under the Paediatric Regulation (2007-2009)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-05-10T02:00:00Z","last_updated_date":"2010-05-10T02:00:00Z","reference_number":"EMA/50813/2009","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-commission-rewards-and-incentives-under-paediatric-regulation-2007-2009_en.pdf"},
    {"id":"32474","name":"EU/3/08/550: Public summary of positive opinion for orphan designation of \n\nnimotuzumab for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2008-08-18T02:00:00Z","reference_number":"EMEA/COMP/196682/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308550-public-summary-positive-opinion-orphan-designation-nimotuzumab-treatment-pancreatic-cancer_en.pdf"},
    {"id":"32477","name":"EU/3/14/1397: Public summary of opinion on orphan designation: Amikacin sulfate for the treatment of Pseudomonas aeuriginosa lung infection\n\nin cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T01:00:00Z","last_updated_date":"2015-02-26T01:00:00Z","reference_number":"EMA/COMP/736592/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141397-public-summary-opinion-orphan-designation-amikacin-sulfate-treatment-pseudomonas-aeuriginosa-lung-infection-cystic-fibrosis_en.pdf"},
    {"id":"32478","name":"PDCO monthly report of opinions on paediatric investigation plans: 11-13 April 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-04-20T17:33:00Z","last_updated_date":"2012-05-22T16:12:00Z","reference_number":"EMA/PDCO/243834/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-11-13-april-2012_en.pdf"},
    {"id":"32479","name":"Questions and answers on refusal of the marketing authorisation for Ninlaro","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T14:00:00Z","last_updated_date":"2016-06-28T12:52:00Z","reference_number":"EMA/358656/2016 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ninlaro_en.pdf"},
    {"id":"32480","name":"Deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications - 2022-2023","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-05-04T02:00:00Z","last_updated_date":"2022-04-25T14:00:00Z","reference_number":"EMADOC-628903358-2283","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/deadlines-submission-applications-orphan-medicinal-product-designation-ema-and-corresponding-comp-timetable-valid-applications-2022-2023_en.pdf"},
    {"id":"32481","name":"European Medicines Agency update on ongoing benefit-risk review of Avandia, Avandamet and Avaglim","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/468928/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-update-ongoing-benefit-risk-review-avandia-avandamet-and-avaglim_en.pdf"},
    {"id":"32484","name":"Withdrawal assessment report for Egrifta","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-10-23T02:00:00Z","last_updated_date":"2012-10-23T02:00:00Z","reference_number":"EMA/588044/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-egrifta_en.pdf"},
    {"id":"32486","name":"Final community herbal monograph on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2014-10-06T02:09:21Z","reference_number":"EMEA/HMPC/244569/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf-0"},
    {"id":"32490","name":"Hydroxyethyl starch Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/PRAC/750422/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"32492","name":"Reflection paper: Minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use in birds against H5 and/or H7 highly pathogenic avian influenza virus","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-02-16T01:00:00Z","last_updated_date":"2006-02-16T01:00:00Z","reference_number":"EMEA/CVMP/IWP/46853/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-minimum-data-requirements-authorisation-under-exceptional-circumstances-vaccines-emergency-use-birds-against-h5-andor-h7-highly-pathogenic-avian-influenza-virus_en.pdf"},
    {"id":"32496","name":"Final list of references supporting the assessment of Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-05-18T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMA/HMPC/3205/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"32497","name":"EU Medicines Agencies Network Strategy to 2020: Summary report of the meeting with Industry Stakeholders Associations for human medicines 23 June 2015: Annex 2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/441188/2015","document_url":"https://www.ema.europa.eu/en/documents/other/eu-medicines-agencies-network-strategy-2020-summary-report-meeting-industry-stakeholders-associations-human-medicines-23-june-2015-annex-2_en.pdf"},
    {"id":"32499","name":"Eighteenth pandemic pharmacovigilance update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"EMA/326582/2010","document_url":"https://www.ema.europa.eu/en/documents/report/eighteenth-pandemic-pharmacovigilance-update_en.pdf"},
    {"id":"32501","name":"CVMP post-authorisation summary of positive opinion for Simparica","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T17:30:00Z","last_updated_date":"2017-09-08T17:30:00Z","reference_number":"EMA/CVMP/557544/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-simparica_en.pdf"},
    {"id":"32506","name":"List of references supporting the assessment report on: Anisi fructus and Anisi aetheroleum Pimpinella anisum L., fructus and Pimpinella anisum L., aetheroleum (aniseed and anise oil)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-06-12T02:00:00Z","last_updated_date":"2014-06-17T02:00:00Z","reference_number":"EMEA/HMPC/359388/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-report-anisi-fructus-and-anisi-aetheroleum-pimpinella-anisum-l-fructus-and-pimpinella-anisum-l-aetheroleum-aniseed-and-anise-oil_en.pdf"},
    {"id":"32507","name":"Public statement on Optimark: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T10:29:00Z","last_updated_date":"2017-12-11T10:29:00Z","reference_number":"EMA/805958/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-optimark-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"32508","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5-7 March 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T18:00:00Z","last_updated_date":"2013-03-08T18:00:00Z","reference_number":"EMA/CVMP/124461/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-5-7-march-2013_en.pdf"},
    {"id":"32510","name":"Piperonyl butoxide: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/537/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/piperonyl-butoxide-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32513","name":"Tuberculin purified protein derivative: List of nationally authorised medicinal products - PSUSA/00003063/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T02:00:00Z","last_updated_date":"2017-05-12T13:48:02Z","reference_number":"EMA/294786/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tuberculin-purified-protein-derivative-list-nationally-authorised-medicinal-products-psusa00003063201609_en.pdf"},
    {"id":"32515","name":"CHMP post-authorisation summary of positive opinion for Emend","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/CHMP/697606/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-emend_en.pdf"},
    {"id":"32516","name":"Draft community herbal monograph on Curcuma longa L., rhizoma","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-11-06T00:09:21Z","last_updated_date":"2008-11-06T00:09:21Z","reference_number":"EMEA/HMPC/456845/2008 Corr","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-curcuma-longa-l-rhizoma_en.pdf"},
    {"id":"32518","name":"EU/3/10/795: Public summary of opinion on orphan designation: Pralatrexate for the treatment of Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2010-10-14T02:00:00Z","reference_number":"EMA/COMP/471332/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310795-public-summary-opinion-orphan-designation-pralatrexate-treatment-hodgkins-lymphoma_en.pdf"},
    {"id":"32519","name":"Azithromycin (systemic use formulations): List of nationally authorised medicinal products - PSUSA/00010491/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-02-27T19:30:00Z","last_updated_date":"2018-02-27T19:32:00Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/azithromycin-systemic-use-formulations-list-nationally-authorised-medicinal-products-psusa00010491201704_en.pdf"},
    {"id":"32521","name":"Working party on Herbal Medicinal Products: Final position paper on the allergenic potency of Herbal Medicinal Products containing soya or peanut protein","type":"position","status":"unknown","consultation_date":"","first_published_date":"2004-06-11T02:00:00Z","last_updated_date":"2004-06-11T02:00:00Z","reference_number":"EMEA/HMPWP/37/04","document_url":"https://www.ema.europa.eu/en/documents/position/working-party-herbal-medicinal-products-final-position-paper-allergenic-potency-herbal-medicinal-products-containing-soya-or-peanut-protein_en.pdf"},
    {"id":"32522","name":"CVMP summary of positive opinion for UpCard","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-05T02:00:00Z","last_updated_date":"2015-06-05T02:00:00Z","reference_number":"EMA/CVMP/292500/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-upcard_en.pdf"},
    {"id":"32526","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Orthosiphon stamineus Benth., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-05-30T02:00:00Z","last_updated_date":"2011-05-30T02:00:00Z","reference_number":"EMA/HMPC/153982/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-orthosiphon-stamineus-benth-folium_en.pdf"},
    {"id":"32527","name":"EU/3/09/655: Public summary of positive opinion for orphan designation of octocog alfa (liposomal) for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-11T02:00:00Z","last_updated_date":"2013-07-08T17:00:00Z","reference_number":"EMEA/COMP/364727/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309655-public-summary-positive-opinion-orphan-designation-octocog-alfa-liposomal-treatment-haemophilia_en.pdf"},
    {"id":"32529","name":"Public statement: European Medicines Agency starts review of the safety of epoetins","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-04-28T01:31:00Z","last_updated_date":"2007-04-28T01:31:00Z","reference_number":"EMEA/188068/2007 - corr","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-european-medicines-agency-starts-review-safety-epoetins_en.pdf"},
    {"id":"32530","name":"Agenda - RD-ACTION, European Medicines Agency, and European Commission-DG SANTE workshop: how European Reference Networks can add value to clinical research","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-05-22T17:36:00Z","last_updated_date":"2018-06-19T18:45:00Z","reference_number":"EMA/270801/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-rd-action-european-medicines-agency-and-european-commission-dg-sante-workshop-how-european-reference-networks-can-add-value-clinical-research_en.pdf"},
    {"id":"32532","name":"Annual report of the interaction with patients and consumers","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-10-10T14:00:00Z","last_updated_date":"2012-10-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/annual-report-interaction-patients-and-consumers_en.pdf"},
    {"id":"32533","name":"EU/3/06/373: Public summary of positive opinion for orphan designation of mecasermin for the treatment of primary insulin-like growth factor-1 deficiencydue to molecular or genetic defects","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-11-19T00:00:00Z","reference_number":"EMEA/COMP/133160/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306373-public-summary-positive-opinion-orphan-designation-mecasermin-treatment-primary-insulin-growth-factor-1-deficiencydue-molecular-or-genetic-defects_en.pdf"},
    {"id":"32534","name":"Final assessment report on Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:00:00Z","last_updated_date":"2016-06-20T12:00:00Z","reference_number":"EMA/HMPC/150846/2015 corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-valeriana-officinalis-l-radix-and-valeriana-officinalis-l-aetheroleum_en.pdf-0"},
    {"id":"32535","name":"Focetria: Labelling","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-05T01:00:00Z","last_updated_date":"2010-03-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/focetria-labelling_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/focetria-labelling_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/focetria-labelling_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/focetria-labelling_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/focetria-labelling_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/focetria-labelling_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/focetria-labelling_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/focetria-labelling_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/focetria-labelling_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/focetria-labelling_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/focetria-labelling_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/focetria-labelling_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/focetria-labelling_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/focetria-labelling_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/focetria-labelling_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/focetria-labelling_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/focetria-labelling_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/focetria-labelling_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/focetria-labelling_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/focetria-labelling_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/focetria-labelling_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/focetria-labelling_sv.pdf"}},
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    {"id":"32555","name":"EU/3/14/1413: Public summary of opinion on orphan designation: Allogeneic, umbilical cord blood-derived, ex vivo-expanded, haematopoietic CD133+ cells / allogeneic, umbilical cord blood-derived, non-expanded, haematopoie...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2018-01-23T01:00:00Z","reference_number":"EMA/COMP/786995/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141413-public-summary-opinion-orphan-designation-allogeneic-umbilical-cord-blood-derived-ex-vivo-expanded-haematopoietic-cd133-cells-allogeneic-umbilical-cord-blood-derived-non-expanded-haematopoie_en.pdf"},
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    {"id":"32567","name":"Final European Union herbal monograph on Agrimonia eupatoria L., herba - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T13:00:00Z","last_updated_date":"2015-04-09T13:00:00Z","reference_number":"EMA/HMPC/680597/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-agrimonia-eupatoria-l-herba-first-version_en.pdf"},
    {"id":"32568","name":"Doramectin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/doramectin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32571","name":"Iffeza - Article 29 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-10-25T02:00:00Z","last_updated_date":"2012-10-25T02:00:00Z","reference_number":"EMA/399722/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/iffeza-article-29-referral-assessment-report_en.pdf"},
    {"id":"32573","name":"Questions and answers on the withdrawal of the marketing authorisation application for Vynfinit (vintafolide)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-06-16T02:00:00Z","last_updated_date":"2015-01-12T14:30:00Z","reference_number":"EMA/302516/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-vynfinit-vintafolide_en.pdf"},
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    {"id":"32594","name":"EU/3/15/1522: Public summary of opinion on orphan designation: Humanised IgG4 monoclonal antibody against extracellular tau for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/430864/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151522-public-summary-opinion-orphan-designation-humanised-igg4-monoclonal-antibody-against-extracellular-tau-treatment-progressive-supranuclear-palsy_en.pdf"},
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    {"id":"32600","name":"Committee for Medicinal Products for Human Use (CHMP) opinions - 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-20T01:00:00Z","last_updated_date":"2014-01-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-human-use-chmp-opinions-2013_en.pdf"},
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    {"id":"32605","name":"Small and medium-sized enterprise (SME) Office annual report 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-05-31T17:00:00Z","last_updated_date":"2017-05-31T17:00:00Z","reference_number":"EMA/790421/2016","document_url":"https://www.ema.europa.eu/en/documents/other/small-and-medium-sized-enterprise-sme-office-annual-report-2016_en.pdf"},
    {"id":"32606","name":"Making a difference to human and animal health - European Medicines Agency and Heads of Medicines Agencies consult on common network strategy to 2020","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-31T02:00:00Z","last_updated_date":"2015-03-31T02:00:00Z","reference_number":"EMA/191095/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/making-difference-human-and-animal-health-european-medicines-agency-and-heads-medicines-agencies-consult-common-network-strategy-2020_en.pdf"},
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    {"id":"32615","name":"EU/3/07/486: Public summary of positive opinion for orphan designation of adenovirus associated viral vector serotype 4 containing the human RPE65 gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMEA/COMP/440597/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307486-public-summary-positive-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-4-containing-human-rpe65-gene-treatment-retinitis-pigmentosa_en.pdf"},
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    {"id":"32619","name":"Assessment report for ergot derivatives containing medicinal products - nicergoline","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"EMA/750632/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-ergot-derivatives-containing-medicinal-products-nicergoline_en.pdf"},
    {"id":"32621","name":"Ketoprofen Extension to pigs): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-03-01T01:00:00Z","last_updated_date":"1996-03-01T01:00:00Z","reference_number":"EMEA/MRL/076/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ketoprofen-extension-pigs-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32624","name":"Scientific recommendation on classification of advanced therapy medicinal products: Sterile suspension on 5.10 viral particles in 0.5ml of A195 buffer","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-08-06T12:00:00Z","last_updated_date":"2013-08-06T12:00:00Z","reference_number":"EMA/479201/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-sterile-suspension-510-viral-particles-05ml-a195-buffer_en.pdf"},
    {"id":"32626","name":"EU/3/12/1016: Public summary of opinion on orphan designation: 16-base single-stranded peptide nucleic acid oligonucleotide linked to 7-amino acid peptide for the treatment of neuroblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2014-04-01T16:00:00Z","reference_number":"EMA/COMP/393098/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121016-public-summary-opinion-orphan-designation-16-base-single-stranded-peptide-nucleic-acid-oligonucleotide-linked-7-amino-acid-peptide-treatment-neuroblastoma_en.pdf"},
    {"id":"32627","name":"ICH guideline Q4B Annex 5 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test - general chapter - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2017-07-13T16:30:00Z","reference_number":"EMA/CHMP/ICH/308895/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-5-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-disintegration-test-general-chapter-step-5_en.pdf"},
    {"id":"32629","name":"Protelos and Osseor Article-20 procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-18T02:00:00Z","last_updated_date":"2014-09-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/protelos-and-osseor-article-20-procedure-annex-iv_sv.pdf"}},
    {"id":"32631","name":"CHMP summary of positive opinion for Chenodeoxycholic acid sigma-tau","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/CHMP/542534/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-chenodeoxycholic-acid-sigma-tau_en.pdf"},
    {"id":"32638","name":"EU/3/04/194: Public summary of positive opinion for orphan designation of adeno-associated viral vector expressing lipoprotein lipase for treatment of lipoprotein-lipase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-03-07T01:00:00Z","last_updated_date":"2021-05-21T02:00:00Z","reference_number":"EMEA/COMP/83/2004 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304194-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-expressing-lipoprotein-lipase-treatment-lipoprotein-lipase-deficiency_en.pdf"},
    {"id":"32639","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: European Society for Developmental Perinatal and Paediatric Pharmacology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-21T12:00:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/203955/2012","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-european-society-developmental-perinatal-and-paediatric-pharmacology_en.pdf"},
    {"id":"32640","name":"Bromocriptine Article-31 referral - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-02T02:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-cmdh-divergent-position_en.pdf"},
    {"id":"32643","name":"Output of the European Medicines Agency policy on access to documents non-related to medicinal products for human and veterinary use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-17T14:30:00Z","last_updated_date":"2018-11-23T13:00:00Z","reference_number":"EMA/183710/2016","document_url":"https://www.ema.europa.eu/en/documents/other/output-european-medicines-agency-policy-access-documents-non-related-medicinal-products-human-and-veterinary-use_en.pdf"},
    {"id":"32644","name":"Legislative framework and scientific guidance in European assessment - Riccardo Luigetti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/legislative-framework-and-scientific-guidance-european-assessment-riccardo-luigetti_en.pdf"},
    {"id":"32645","name":"CHMP post-authorisation summary of positive opinion for RoActemra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-roactemra_en.pdf-2"},
    {"id":"32647","name":"Final assessment report on Melissa officinalis L., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-08-05T17:00:00Z","last_updated_date":"2013-08-05T17:00:00Z","reference_number":"EMA/HMPC/196746/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-melissa-officinalis-l-folium_en.pdf"},
    {"id":"32648","name":"Vancomycin Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2017-03-03T01:00:00Z","reference_number":"EMA/CHMP/224121/2016 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/vancomycin-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"32649","name":"CVMP summary of positive opinion for Ingelvac PCV FLEX","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/CVMP/132641/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-ingelvac-pcv-flex_en.pdf"},
    {"id":"32652","name":"CHMP summary of positive opinion for Spectrila","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-11-20T01:00:00Z","last_updated_date":"2015-11-20T01:00:00Z","reference_number":"EMA/CHMP/730109/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-spectrila_en.pdf"},
    {"id":"32653","name":"Bromocriptine Article-31 referral - PRAC recommends restricted use of bromocriptine for stopping breast milk production","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-07-11T14:00:00Z","last_updated_date":"2014-07-11T14:00:00Z","reference_number":"EMA/409529/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-prac-recommends-restricted-use-bromocriptine-stopping-breast-milk-production_en.pdf"},
    {"id":"32655","name":"Marketing authorisation: The evaluation process - Dr Evdokia Korakianiti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/marketing-authorisation-evaluation-process-dr-evdokia-korakianiti_en.pdf"},
    {"id":"32659","name":"Revised framework for interaction between the European Medicines Agency and healthcare professionals Revised framework of interaction between EMA and healthcare professionals - Annex II - EMA activities where healthcare professionals are involved","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T13:00:00Z","last_updated_date":"2017-02-03T13:00:00Z","reference_number":"EMA/677917/2016","document_url":"https://www.ema.europa.eu/en/documents/other/revised-framework-interaction-between-european-medicines-agency-and-healthcare-professionals-revised-framework-interaction-between-ema-and-healthcare-professionals-annex-ii-ema-activities-where_en.pdf"},
    {"id":"32661","name":"EU/3/02/126: Public summary of positive opinion for orphan designation of recombinant inhibitor of human plasma kallikrein for the treatment of angioedema","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMEA/COMP/2714/02 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302126-public-summary-positive-opinion-orphan-designation-recombinant-inhibitor-human-plasma-kallikrein-treatment-angioedema_en.pdf"},
    {"id":"32662","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone marrow-derived CD133+ stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T10:15:00Z","last_updated_date":"2011-11-29T10:15:00Z","reference_number":"EMA/921674/2011","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-derived-cd133-stem-cells_en.pdf"},
    {"id":"32665","name":"Final assessment report on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-07-07T02:00:00Z","reference_number":"EMA/HMPC/80628/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-cortex_en.pdf"},
    {"id":"32667","name":"Potassium glucuronate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-07-01T02:00:00Z","last_updated_date":"1997-07-01T02:00:00Z","reference_number":"EMEA/MRL/238/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/potassium-glucuronate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32668","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 16-19 May 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-05-20T02:00:00Z","last_updated_date":"2011-05-20T02:00:00Z","reference_number":"EMA/CHMP/306703/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-may-2011_en.pdf"},
    {"id":"32672","name":"Presentation - 'Snapshot' of transversal activities regarding ERNs and clinical research (Eduardo Là³pez Granados, Eileen Treacy, Daria Julkowska)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-snapshot-transversal-activities-regarding-erns-and-clinical-research-eduardo-la3pez-granados-eileen-treacy-daria-julkowska_en.pdf"},
    {"id":"32673","name":"EU/3/12/956: Public summary of opinion on orphan designation: Human monoclonal antibody against Fas ligand for the treatment of pemphigus","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2012-03-01T01:00:00Z","reference_number":"EMA/982984/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312956-public-summary-opinion-orphan-designation-human-monoclonal-antibody-against-fas-ligand-treatment-pemphigus_en.pdf"},
    {"id":"32675","name":"EU/3/03/182: Public summary of positive opinion for orphan designation of 5-methyl-pyridine-2-sulfonic acid 6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-\n\n(2-1H-tetrazol-5-yl-pyridin-4-yl)-pyrimidin-4-ylamide sodium salt (...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T00:00:00Z","last_updated_date":"2015-03-24T00:00:00Z","reference_number":"EMEA/COMP/1563/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303182-public-summary-positive-opinion-orphan-designation-5-methyl-pyridine-2-sulfonic-acid-6-2-hydroxyethoxy-5-2-methoxyphenoxy-2-2-1h-tetrazol-5-yl-pyridin-4-yl-pyrimidin-4-ylamide-sodium-salt_en.pdf"},
    {"id":"32677","name":"Gadolinium Article-31 referral – Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2017-05-30T10:45:00Z","reference_number":"EMA/PRAC/195601/2016 Rev.7","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"32679","name":"EU/3/12/1043: Public summary of opinion on orphan designation: N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine to be used with fo...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-09-27T16:00:00Z","last_updated_date":"2021-12-07T16:00:00Z","reference_number":"EMA/COMP/554957/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121043-public-summary-opinion-orphan-designation-n-4-2-amino-34-dihydro-4-oxo-6-pteridinylmethylaminobenzoyl-d-gamma-glutamyl-2s-2-amino-beta-alanyl-l-alpha-aspartyl-l-cysteine-be-used-fo_en.pdf"},
    {"id":"32682","name":"Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-01-30T01:00:00Z","last_updated_date":"2015-01-30T01:00:00Z","reference_number":"EMA/CVMP/SWP/90250/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-risk-characterisation-and-assessment-maximum-residue-limits-mrl-biocides_en.pdf"},
    {"id":"32683","name":"CHMP summary of opinion for Zinbryta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2018-05-02T02:00:00Z","reference_number":"EMA/CHMP/268320/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-zinbryta_en.pdf"},
    {"id":"32684","name":"Zinbryta Article-20 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-07T02:00:00Z","last_updated_date":"2017-09-01T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-annex-iii_en.pdf-0"},
    {"id":"32687","name":"Draft guideline on clinical investigation of medicinal products used in weight control","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"CPMP/EWP/281/96 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-used-weight-control_en.pdf"},
    {"id":"32688","name":"Public summary of the evaluation of a proposed product-specific waiver: \n\nCandesartan (cilexetil)/amlodipine (besilate) for treatment of essential hypertension","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/89429/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-candesartan-cilexetilamlodipine-besilate-treatment-essential-hypertension_en.pdf"},
    {"id":"32690","name":"Agenda - Workshop on site and histology - Independent indications in oncology","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-30T16:00:00Z","last_updated_date":"2017-12-14T12:00:00Z","reference_number":"EMA/CHMP/673240/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-site-and-histology-independent-indications-oncology_en.pdf"},
    {"id":"32692","name":"Orphan Designation - Key concepts and evaluation criteria - Jordi Llinares","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/orphan-designation-key-concepts-and-evaluation-criteria-jordi-llinares_en.pdf"},
    {"id":"32693","name":"CVMP post-authorisation summary of positive opinion for Naxcel","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-05-06T02:00:00Z","last_updated_date":"2011-05-06T02:00:00Z","reference_number":"EMA/CVMP/62249/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-naxcel_en.pdf"},
    {"id":"32694","name":"Draft assessment report on Carum carvi L., fructus and Carum carvi L. aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2014-12-22T17:30:00Z","last_updated_date":"2014-12-22T17:30:00Z","reference_number":"EMA/HMPC/715093/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-carum-carvi-l-fructus-and-carum-carvi-l-aetheroleum_en.pdf-0"},
    {"id":"32697","name":"Presentation - Veterinary antimicrobials: State of play and future developments (Mario Nagtzaam)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-antimicrobials-state-play-and-future-developments-mario-nagtzaam_en.pdf"},
    {"id":"32698","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the June 2008 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-06-13T02:09:21Z","last_updated_date":"2008-06-13T02:09:21Z","reference_number":"EMEA/COMP/308994/08","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-june-2008-meeting_en.pdf"},
    {"id":"32701","name":"Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implement...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-10-17T15:48:25Z","reference_number":"EMA/473578/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/glycopyrronium-bromide-all-indications-except-chronic-obstructive-pulmonary-disease-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implement_en.pdf"},
    {"id":"32702","name":"Presentation - Outcome of consultation on additional monitoring of medicines and adverse-drug-reaction reporting – impact on the product information","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outcome-consultation-additional-monitoring-medicines-and-adverse-drug-reaction-reporting-impact-product-information_en.pdf"},
    {"id":"32704","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 16-19 November 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-11-20T00:09:21Z","last_updated_date":"2009-11-20T00:09:21Z","reference_number":"EMEA/CHMP/752431/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-16-19-november-2009_en.pdf"},
    {"id":"32706","name":"Presentation - Best expertise vs conflicts of interest: Striking the right balance (Nikos Dedes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-best-expertise-vs-conflicts-interest-striking-right-balance-nikos-dedes_en.pdf"},
    {"id":"32710","name":"EU/3/06/349: Public summary of positive opinion for orphan designation of apomorphine hydrochloride (inhalation use) for the treatment of off-periods in Parkinson’s disease not responding to oral treatment","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-08-24T02:00:00Z","last_updated_date":"2006-08-24T02:00:00Z","reference_number":"EMEA/COMP/25291/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306349-public-summary-positive-opinion-orphan-designation-apomorphine-hydrochloride-inhalation-use-treatment-periods-parkinsons-disease-not-responding-oral-treatment_en.pdf"},
    {"id":"32711","name":"CHMP post-authorisation summary of positive opinion for Simponi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/CHMP/793256/2010","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-simponi_en.pdf-2"},
    {"id":"32713","name":"Presentation - European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) (Alexander Natz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-confederation-pharmaceutical-entrepreneurs-eucope-alexander-natz_en.pdf"},
    {"id":"32714","name":"Public statement on Theryttrex (yttrium (90Y) chloride): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2006-03-02T12:09:21Z","last_updated_date":"2006-03-02T12:09:21Z","reference_number":"CHMP/71254/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-theryttrex-yttrium-90y-chloride-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"32717","name":"Zometa: Withdrawal letter","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/zometa-withdrawal-letter_en.pdf"},
    {"id":"32719","name":"Presentation - SME workshop: Session 4: Statistical considerations in confirmatory clinical trials II (Oliver Keene)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-29T10:40:00Z","last_updated_date":"2016-02-29T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-workshop-session-4-statistical-considerations-confirmatory-clinical-trials-ii-oliver-keene_en.pdf"},
    {"id":"32720","name":"EU/3/17/1918: Public summary of opinion on orphan designation: Autologous ex vivo expanded peripheral polyclonal lymphocytes enriched in activated natural killer cells for the treatment of multiple myeloma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-10T10:25:00Z","last_updated_date":"2018-01-10T10:25:00Z","reference_number":"EMA/617444/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171918-public-summary-opinion-orphan-designation-autologous-ex-vivo-expanded-peripheral-polyclonal-lymphocytes-enriched-activated-natural-killer-cells-treatment-multiple-myeloma_en.pdf"},
    {"id":"32722","name":"VICH GL12: Efficacy of anthelmintics: specific recommendations for bovines - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-12-10T01:00:00Z","last_updated_date":"1999-12-10T01:00:00Z","reference_number":"CVMP/VICH/839/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl12-efficacy-anthelmintics-specific-recommendations-bovines-step-7_en.pdf"},
    {"id":"32724","name":"Autologous antigen-specific regulatory T lymphocytes suspended in a cryopreservation medium","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-07-11T13:00:00Z","last_updated_date":"2014-07-11T13:00:00Z","reference_number":"EMA/421170/2014","document_url":"https://www.ema.europa.eu/en/documents/report/autologous-antigen-specific-regulatory-t-lymphocytes-suspended-cryopreservation-medium_en.pdf"},
    {"id":"32726","name":"Calcitriol: List of nationally authorised medicinal products - PSUSA/00000495/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-13T02:00:00Z","last_updated_date":"2016-10-18T14:01:10Z","reference_number":"EMA/677233/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcitriol-list-nationally-authorised-medicinal-products-psusa00000495201501_en.pdf"},
    {"id":"32732","name":"Bilastine: List of nationally authorised medicinal products - PSUSA/00003163/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-22T10:45:00Z","last_updated_date":"2016-11-22T10:45:00Z","reference_number":"EMA/761543/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/bilastine-list-nationally-authorised-medicinal-products-psusa00003163201603_en.pdf"},
    {"id":"32733","name":"EU/3/12/1045: Public summary of opinion on orphan designation: Alpha-1 proteinase inhibitor (for inhalation use) for the treatment of cystic fibrosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T17:00:00Z","last_updated_date":"2012-11-16T17:00:00Z","reference_number":"EMA/COMP/612138/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121045-public-summary-opinion-orphan-designation-alpha-1-proteinase-inhibitor-inhalation-use-treatment-cystic-fibrosis_en.pdf"},
    {"id":"32734","name":"Eleventh Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1996-09-26T02:00:00Z","last_updated_date":"1996-09-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/eleventh-meeting-management-board_en.pdf"},
    {"id":"32739","name":"Presentation - Experience from patient observer in Pharmacovigilance Working Party","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:07Z","last_updated_date":"2011-06-24T22:06:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-patient-observer-pharmacovigilance-working-party_en.pdf"},
    {"id":"32740","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n10-13 December 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"EMEA/CHMP/583851/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-10-13-december-2007_en.pdf"},
    {"id":"32746","name":"Committee on herbal medicinal products (HMPC): Meeting report, 5-6 November 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T00:00:00Z","last_updated_date":"2008-11-20T00:00:00Z","reference_number":"EMEA/HMPC/610485/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-5-6-november-2008_en.pdf"},
    {"id":"32749","name":"Presentation - An Agency on the move (David Mackay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agency-move-david-mackay_en.pdf"},
    {"id":"32751","name":"Azithromycin (ocular use formulations): List of nationally authorised medicinal products - PSUSA/00010492/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-17T14:55:00Z","last_updated_date":"2018-01-17T15:10:00Z","reference_number":"EMA/28946/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/azithromycin-ocular-use-formulations-list-nationally-authorised-medicinal-products-psusa00010492201704_en.pdf"},
    {"id":"32752","name":"Annex B - Response questionnaire","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-10-12T02:00:00Z","last_updated_date":"2009-10-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-b-response-questionnaire_en.xls"},
    {"id":"32753","name":"Spiramycin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-02-19T01:00:00Z","last_updated_date":"1997-02-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spiramycin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32754","name":"Opinion following an article 33 referral for Cobactan IV 4.5% powder and solvent for solution for injection and its associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-12T02:00:00Z","last_updated_date":"2014-08-12T02:00:00Z","reference_number":"EMA/249659/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-cobactan-iv-45-powder-and-solvent-solution-injection-and-its-associated-names_en.pdf"},
    {"id":"32757","name":"CHMP post-authorisation summary of positive opinion for Cabometyx (II-03)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T15:46:00Z","last_updated_date":"2018-03-23T15:46:00Z","reference_number":"EMA/CHMP/175713/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cabometyx-ii-03_en.pdf"},
    {"id":"32759","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 May 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-06-02T02:09:21Z","last_updated_date":"2006-06-02T02:09:21Z","reference_number":"EMEA/204606/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-24-27-may-2006_en.pdf"},
    {"id":"32761","name":"Fusafungine Article-31 referral - CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/227560/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fusafungine-article-31-referral-cmdh-endorses-revocation-authorisations-fusafungine-sprays-used-treat-airway-infections_sv.pdf"}},
    {"id":"32762","name":"Third report on the progress of the interaction with patients' and consumers' organisations during 2009","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-11-22T13:13:18Z","last_updated_date":"2010-11-22T13:13:18Z","reference_number":"EMA/MB/117170/2010","document_url":"https://www.ema.europa.eu/en/documents/report/third-report-progress-interaction-patients-and-consumers-organisations-during-2009_en.pdf"},
    {"id":"32764","name":"Furosemide: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-09-01T02:00:00Z","last_updated_date":"1999-09-01T02:00:00Z","reference_number":"EMEA/MRL/644/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/furosemide-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32767","name":"EU/3/16/1785: Public summary of positive opinion for orphan designation of R-azasetron besylate for the treatment of sudden sensorineural hearing loss","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2016-12-13T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161785-public-summary-positive-opinion-orphan-designation-r-azasetron-besylate-treatment-sudden-sensorineural-hearing-loss_en.pdf"},
    {"id":"32769","name":"EU/3/17/1930: Public summary of opinion on orphan designation: Seladelpar for the treatment of primary biliary cholangitis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-10T10:25:00Z","last_updated_date":"2018-01-10T10:25:00Z","reference_number":"EMA/634183/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171930-public-summary-opinion-orphan-designation-seladelpar-treatment-primary-biliary-cholangitis_en.pdf"},
    {"id":"32771","name":"Presentation - Reflection paper on the use of patient reported outcome (PRO) measures in oncology studies (Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reflection-paper-use-patient-reported-outcome-pro-measures-oncology-studies-daniel-oconnor_en.pdf"},
    {"id":"32772","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) Anatomical Therapeutic Chemical (ATC) code addition","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:01Z","last_updated_date":"2014-01-17T18:15:00Z","reference_number":"EMA/136151/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-anatomical-therapeutic-chemical-atc-code-addition_en.xls"},
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    {"id":"32827","name":"Tisseel and associated names: Product information as approved by the CHMP on 13 December 2012, pending endorsement by the European Commission","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T11:00:00Z","last_updated_date":"2012-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tisseel-and-associated-names-product-information-approved-chmp-13-december-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"32828","name":"CHMP highlights November 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-11T01:00:00Z","last_updated_date":"2016-11-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-highlights-november-2016_en.pdf"},
    {"id":"32829","name":"Agenda - Focus group meeting - Revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-11-27T01:00:00Z","last_updated_date":"2013-11-27T01:00:00Z","reference_number":"EMA/408480/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-focus-group-meeting-revision-cvmp-guideline-demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances_en.pdf"},
    {"id":"32830","name":"Presentation - Session 5: Post-approval confirmatory/supplementary data: registries and observational trials (Vincent Ho)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-post-approval-confirmatorysupplementary-data-registries-and-observational-trials-vincent-ho_en.pdf"},
    {"id":"32831","name":"Cefazolin (Extension to sheep and goats): Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-09-01T02:00:00Z","last_updated_date":"1997-09-01T02:00:00Z","reference_number":"EMEA/MRL/257/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefazolin-extension-sheep-and-goats-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32834","name":"EU/3/16/1706: Public summary of opinion on orphan designation: Sodium benzoate for the treatment of carbamoyl-phosphate synthase-1 deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/449116/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161706-public-summary-opinion-orphan-designation-sodium-benzoate-treatment-carbamoyl-phosphate-synthase-1-deficiency_en.pdf"},
    {"id":"32835","name":"Presentation - D-E-R characterisation in dose selection, labelling and B/R assessment: focus on the elderly (Terry Shepard, Sue Morgan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-d-e-r-characterisation-dose-selection-labelling-and-br-assessment-focus-elderly-terry-shepard-sue-morgan_en.pdf"},
    {"id":"32836","name":"Presentation - Report on measures of impact of pharmacovigilance processes (Marieke De Bruin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-report-measures-impact-pharmacovigilance-processes-marieke-de-bruin_en.pdf"},
    {"id":"32837","name":"Overview of comments received on 'guideline on requirements for the production and control of immunological veterinary medicinal products' - First version","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-06-21T11:45:00Z","last_updated_date":"2012-06-21T11:45:00Z","reference_number":"EMA/CVMP/IWP/913310/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-requirements-production-and-control-immunological-veterinary-medicinal-products-first-version_en.pdf"},
    {"id":"32839","name":"Call for scientific data for the update of advice on the impact on public health and animal health of the use of antibiotics in animals (colistin) following the recent discovery of the first mobile colistin resistance gene (mcr-1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-29T16:00:00Z","last_updated_date":"2016-02-29T16:00:00Z","reference_number":"EMA/103285/2016","document_url":"https://www.ema.europa.eu/en/documents/other/call-scientific-data-update-advice-impact-public-health-and-animal-health-use-antibiotics-animals-colistin-following-recent-discovery-first-mobile-colistin-resistance-gene-mcr-1_en.pdf"},
    {"id":"32841","name":"Ergot derivatives Article-31 referral - Dihydroergocristine - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergocristine-annex-ii_sv.pdf"}},
    {"id":"32844","name":"PRAC – first experience","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-10T14:00:00Z","last_updated_date":"2012-10-10T14:00:00Z","reference_number":"EMA/598943/201212","document_url":"https://www.ema.europa.eu/en/documents/other/prac-first-experience_en.pdf"},
    {"id":"32847","name":"Opinion of the CVMP on the establishment of maximum residue limits: Closantel","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-09-08T19:00:00Z","last_updated_date":"2014-09-08T19:00:00Z","reference_number":"EMA/CVMP/741512/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-closantel_en.pdf-0"},
    {"id":"32848","name":"CHMP post-authorisation summary of positive opinion for Inovelon","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T14:00:00Z","last_updated_date":"2018-06-29T14:00:00Z","reference_number":"EMA/CHMP/414679/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-inovelon_en.pdf"},
    {"id":"32849","name":"EU/3/03/170: Public summary of positive opinion for orphan designation of human immunoglobulin for the treatment of polymyositis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2004-04-26T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMEA/COMP/1443/2003 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303170-public-summary-positive-opinion-orphan-designation-human-immunoglobulin-treatment-polymyositis_en.pdf"},
    {"id":"32851","name":"Presentation - Example of joint symposium organized by UEG and EMA (Michel Delvaux)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-example-joint-symposium-organized-ueg-and-ema-michel-delvaux_en.pdf"},
    {"id":"32853","name":"Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-05-29T18:00:00Z","last_updated_date":"2018-05-29T18:00:00Z","reference_number":"EMA/213044/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting_en.pdf-0"},
    {"id":"32854","name":"Committee for medicinal products for human use, summary of positive opinion for Kuvan","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-09-25T02:00:00Z","last_updated_date":"2008-09-25T02:00:00Z","reference_number":"EMEA/CHMP/434814/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-kuvan_en.pdf"},
    {"id":"32855","name":"Benfluorex - Article 107 referral - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/benfluorex-article-107-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/benfluorex-article-107-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/benfluorex-article-107-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/benfluorex-article-107-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/benfluorex-article-107-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/benfluorex-article-107-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/benfluorex-article-107-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/benfluorex-article-107-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/benfluorex-article-107-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/benfluorex-article-107-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/benfluorex-article-107-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/benfluorex-article-107-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/benfluorex-article-107-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/benfluorex-article-107-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/benfluorex-article-107-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/benfluorex-article-107-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/benfluorex-article-107-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/benfluorex-article-107-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/benfluorex-article-107-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/benfluorex-article-107-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/benfluorex-article-107-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/benfluorex-article-107-referral-annex-ii_sv.pdf"}},
    {"id":"32856","name":"16th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-09-13T02:00:00Z","last_updated_date":"2001-09-13T02:00:00Z","reference_number":"EMEA/COMP/385/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/16th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"32857","name":"Declaration of interests: Mihaela Savastre","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-04T01:00:00Z","last_updated_date":"2016-09-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-mihaela-savastre_en.pdf"},
    {"id":"32859","name":"First-in-class medicine to prevent bleeding in haemophilia A patients with inhibitors","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-01-26T13:00:00Z","reference_number":"EMA/CHMP/43074/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-class-medicine-prevent-bleeding-haemophilia-patients-inhibitors_en.pdf"},
    {"id":"32861","name":"European Medicines Agency recommends new contra-indications and warnings for pioglitazone to reduce small increased risk of bladder cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-07-21T02:00:00Z","last_updated_date":"2011-07-21T02:00:00Z","reference_number":"EMA/CHMP/568262/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-new-contra-indications-and-warnings-pioglitazone-reduce-small-increased-risk-bladder-cancer_en.pdf"},
    {"id":"32865","name":"Xofigo Article-20 procedure - Assessment report on provisional measures","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-21T11:32:00Z","last_updated_date":"2018-03-21T11:32:00Z","reference_number":"EMA/176752/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/xofigo-article-20-procedure-assessment-report-provisional-measures_en.pdf"},
    {"id":"32866","name":"EU/3/10/754: Public summary of opinion on orphan designation: Heparin-activated recombinant human fibroblast growth factor 1 (on a biodegradable device ade from alpha-calcium sulphate hemihydrate) for the treatment of tr...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-05T02:00:00Z","last_updated_date":"2021-02-03T02:00:00Z","reference_number":"EMA/COMP/269110/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310754-public-summary-opinion-orphan-designation-heparin-activated-recombinant-human-fibroblast-growth-factor-1-biodegradable-device-ade-alpha-calcium-sulphate-hemihydrate-treatment-tr_en.pdf"},
    {"id":"32867","name":"EMEA SME workshop biological GMP issues - Ian Rees","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-sme-workshop-biological-gmp-issues-ian-rees_en.pdf"},
    {"id":"32869","name":"Presentation - Orphan designation system in Japan (Ministry of Health,\n\nLabour and Welfare)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orphan-designation-system-japan-ministry-health-labour-and-welfare_en.pdf"},
    {"id":"32870","name":"EU/3/15/1599: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype rh10 containing the human factor IX gene for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2022-10-11T01:00:00Z","reference_number":"EMA/COMP/776835/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151599-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-rh10-containing-human-factor-ix-gene-treatment-haemophilia-b_en.pdf"},
    {"id":"32871","name":"Update on review of valsartan medicines following detection of impurity in active substance","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-07-17T16:00:00Z","last_updated_date":"2018-07-17T16:00:00Z","reference_number":"EMA/485921/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-review-valsartan-medicines-following-detection-impurity-active-substance_en.pdf"},
    {"id":"32872","name":"Overview of comments received on 'appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (EMA/CHMP/60095...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-11-18T16:51:00Z","last_updated_date":"2011-11-18T16:51:00Z","reference_number":"EMA/CHMP/643484/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-appendix-iv-guideline-investigation-bioequivalence-cpmpewpqwp140198-rev1-presentation-biopharmaceutical-and-bioanalytical-data-module-271-emachmp60095_en.pdf"},
    {"id":"32874","name":"Flumequine: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/624/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flumequine-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32875","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T17:10:00Z","last_updated_date":"2014-11-14T17:10:00Z","reference_number":"EMA/629261/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-october-2014_en.pdf"},
    {"id":"32877","name":"New guide on biosimilar medicines for healthcare professionals - Increasing understanding of biosimilar medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/270182/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-guide-biosimilar-medicines-healthcare-professionals-increasing-understanding-biosimilar-medicines_en.pdf"},
    {"id":"32878","name":"Conclusions of ECHAMP (European Coalition on Homeopathic and Anthroposophic Medicinal Products)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/conclusions-echamp-european-coalition-homeopathic-and-anthroposophic-medicinal-products_en.pdf"},
    {"id":"32881","name":"Presentation - European Group for Generic Veterinary Products (EGGVP): Advice on the impact on the use of antibiotics in animals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-group-generic-veterinary-products-eggvp-advice-impact-use-antibiotics-animals_en.pdf"},
    {"id":"32882","name":"EU/3/15/1472: Public summary of positive opinion for orphan designation of Fluciclovine (18F) for the diagnosis of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-21T14:00:00Z","last_updated_date":"2015-05-21T14:00:00Z","reference_number":"EMA/COMP/212725/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151472-public-summary-positive-opinion-orphan-designation-fluciclovine-18f-diagnosis-glioma_en.pdf"},
    {"id":"32883","name":"Guideline on the evaluation of anticancer medicinal products in man - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-12-14T00:09:00Z","last_updated_date":"2005-12-14T00:09:00Z","reference_number":"CPMP/EWP/205/95/Rev.3/Corr.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-anticancer-medicinal-products-man-revision-3_en.pdf"},
    {"id":"32884","name":"Presentation - Clinical development issues in progressive multiple sclerosis(Volker Knappertz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-development-issues-progressive-multiple-sclerosisvolker-knappertz_en.pdf"},
    {"id":"32885","name":"Presentation - Participation of civil society in scientific advisory groups","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-participation-civil-society-scientific-advisory-groups_en.pdf"},
    {"id":"32887","name":"CHMP summary of positive opinion for Fulvestrant Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"EMA/CHMP/734315/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fulvestrant-mylan_en.pdf"},
    {"id":"32888","name":"Overview of comments received on 'Draft good practice guide on recording, coding, reporting and assessment of medication errors' (EMA/762563/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-11-27T11:00:00Z","last_updated_date":"2015-11-27T11:00:00Z","reference_number":"EMA/190895/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-good-practice-guide-recording-coding-reporting-and-assessment-medication-errors-ema7625632014_en.pdf"},
    {"id":"32889","name":"Ketoconazole Article-31 referral - European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/458028/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoconazole-article-31-referral-european-medicines-agency-recommends-suspension-marketing-authorisations-oral-ketoconazole_en.pdf"},
    {"id":"32891","name":"Draft guideline on clinical medicinal products intended for the treatment of neuropathic pain","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-01-26T01:00:00Z","last_updated_date":"2006-01-26T01:00:00Z","reference_number":"CPMP/EWP/252/03 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-medicinal-products-intended-treatment-neuropathic-pain_en.pdf"},
    {"id":"32893","name":"Medical literature monitoring by EMA - Training module EV-M7","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2017-06-26T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/medical-literature-monitoring-ema-training-module-ev-m7_en.pdf"},
    {"id":"32894","name":"2015 annual report on EudraVigilance for the European Parliament, the Council and the Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-21T17:00:00Z","last_updated_date":"2016-03-21T17:00:00Z","reference_number":"EMA/34490/2016 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/report/2015-annual-report-eudravigilance-european-parliament-council-and-commission_en.pdf"},
    {"id":"32895","name":"Restriction of combined use of medicines affecting the renin-angiotensin system (RAS)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-08T02:00:00Z","last_updated_date":"2014-10-08T02:00:00Z","reference_number":"EMA/554928/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/restriction-combined-use-medicines-affecting-renin-angiotensin-system-ras_sv.pdf"}},
    {"id":"32896","name":"Revision of ICH M3 - Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals - David R Jones","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/revision-ich-m3-non-clinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorisation-pharmaceuticals-david-r-jones_en.pdf"},
    {"id":"32898","name":"Report on the survey of all paediatric uses of medicinal\n\nproducts in Europe","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-01-21T00:31:00Z","last_updated_date":"2011-01-21T00:31:00Z","reference_number":"EMA/794083/2009","document_url":"https://www.ema.europa.eu/en/documents/report/report-survey-all-paediatric-uses-medicinal-products-europe_en.pdf"},
    {"id":"32900","name":"Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-06-30T19:00:00Z","last_updated_date":"2017-06-30T19:00:00Z","reference_number":"EMA/237265/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/gaucher-disease-strategic-collaborative-approach-european-medicines-agency-and-food-and-drug-administration_en.pdf"},
    {"id":"32901","name":"Compliance check & Validation of applications with an agreed PIP Ali Harrison - AstraZeneca","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/compliance-check-validation-applications-agreed-pip-ali-harrison-astrazeneca_en.pdf"},
    {"id":"32903","name":"European Medicines Agency publishes 2012 annual report","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-16T18:00:00Z","last_updated_date":"2013-04-16T18:00:00Z","reference_number":"EMA/235758/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-publishes-2012-annual-report_en.pdf"},
    {"id":"32906","name":"Presentation - Nuffield Council on Bioethics’ report: Children and clinical research: ethical issues","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nuffield-council-bioethics-report-children-and-clinical-research-ethical-issues_en.pdf"},
    {"id":"32907","name":"Presentation - Annual general meeting (AGM) - Progress report","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T17:00:00Z","last_updated_date":"2013-07-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-annual-general-meeting-agm-progress-report_en.pdf"},
    {"id":"32908","name":"Draft list of references for assessment of: Salviae folium Salvia officinalis L., folium (sage leaf)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2009-01-14T01:00:00Z","last_updated_date":"2009-01-14T01:00:00Z","reference_number":"EMEA/HMPC/331645/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-salviae-folium-salvia-officinalis-l-folium-sage-leaf_en.pdf"},
    {"id":"32911","name":"Highlight report of the Industry stakeholder platform on research and development support","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-23T18:39:00Z","last_updated_date":"2017-05-23T18:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/highlight-report-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"32912","name":"Presentation - Time for the European reference relative efficacy assessment (Francesco De Lorenzo) - S6.3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-time-european-reference-relative-efficacy-assessment-francesco-de-lorenzo-s63_en.pdf"},
    {"id":"32915","name":"CVMP summary of positive opinion for MS-H vaccine","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/CVMP/232001/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-ms-h-vaccine_en.pdf"},
    {"id":"32916","name":"Final list of references supporting the assessment of Vaccinium myrtillus L., fructus recens and Vaccinium myrtillus L., fructus siccus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"EMA/HMPC/678996/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-vaccinium-myrtillus-l-fructus-recens-and-vaccinium-myrtillus-l-fructus-siccus_en.pdf"},
    {"id":"32917","name":"CHMP summary of positive opinion for Alkindi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/CHMP/817958/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-alkindi_en.pdf"},
    {"id":"32918","name":"Presentation - Looking forward: better communications for better healthcare decisions (Monika Benstetter, Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T01:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-looking-forward-better-communications-better-healthcare-decisions-monika-benstetter-juan-garcia-burgos_en.pdf"},
    {"id":"32920","name":"Revlimid: Product information as approved by the CHMP on 22 September 2011, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/revlimid-product-information-approved-chmp-22-september-2011-pending-endorsement-european-commission_en.pdf"},
    {"id":"32925","name":"Appendix - checklist for the transfer of PMF to a new Holder","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-10-07T02:09:21Z","last_updated_date":"2009-10-07T02:09:21Z","reference_number":"EMEA/63698/2007","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-checklist-transfer-pmf-new-holder_en.doc"},
    {"id":"32926","name":"Agenda - GCC Biosimilar Medicinal Products Workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-gcc-biosimilar-medicinal-products-workshop_en.pdf"},
    {"id":"32927","name":"Superseded overview of comments received on Community herbal monograph on Gentiana lutea L., radix - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2010-03-08T01:00:00Z","last_updated_date":"2010-03-08T01:00:00Z","reference_number":"EMA/HMPC/573967/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-gentiana-lutea-l-radix-first-version_en.pdf"},
    {"id":"32928","name":"Letter of support for Patient Data Platform for capturing patient-reported outcome measures for Dravet syndrome","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T14:30:00Z","last_updated_date":"2016-05-19T14:30:00Z","reference_number":"EMA/327846/2016","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-patient-data-platform-capturing-patient-reported-outcome-measures-dravet-syndrome_en.pdf"},
    {"id":"32929","name":"Presentation - 6.5 Optimal design for trials with discrete longitudinal studies with uncertainty on model and parameters (France Mentrà©, Florence Loingeville, Marie Karelle Rivià¨re, Thu Thuy Nguyen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-65-optimal-design-trials-discrete-longitudinal-studies-uncertainty-model-and-parameters-france-mentrac-florence-loingeville-marie-karelle-riviare-thu-thuy-nguyen_en.pdf"},
    {"id":"32930","name":"Withdrawal letter: Qutenza","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-04-16T02:00:00Z","last_updated_date":"2012-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-qutenza_en.pdf"},
    {"id":"32932","name":"Phoxim (pigs): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/752/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phoxim-pigs-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"32934","name":"Phenylephrine: List of nationally authorised medicinal products - PSUSA/00002378/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-03T01:00:00Z","last_updated_date":"2016-10-17T18:19:00Z","reference_number":"EMA/726964/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/phenylephrine-list-nationally-authorised-medicinal-products-psusa00002378201501_en.pdf"},
    {"id":"32935","name":"European Medicines Agency’s interaction with industry stakeholders - Annual report 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-06-16T15:30:00Z","last_updated_date":"2017-06-16T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencys-interaction-industry-stakeholders-annual-report-2016_en.pdf"},
    {"id":"32936","name":"Technical specification - Annex 11 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-11-external-service-providers-software-applications-ema201213ict_en.pdf"},
    {"id":"32937","name":"Presentation - Nanomedicines interaction with biological systems, Kenneth Dawson, University College of Dublin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nanomedicines-interaction-biological-systems-kenneth-dawson-university-college-dublin_en.pdf"},
    {"id":"32938","name":"Guideline on clinical investigation of medicinal products indicated for the treatment of Psoriasis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-11-18T01:00:00Z","last_updated_date":"2004-11-18T01:00:00Z","reference_number":"CHMP/EWP/2454/02 corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-indicated-treatment-psoriasis_en.pdf"},
    {"id":"32939","name":"Reflection paper on surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-08-15T16:56:00Z","last_updated_date":"2013-08-15T16:56:00Z","reference_number":"EMA/325027/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-surface-coatings-general-issues-consideration-regarding-parenteral-administration-coated-nanomedicine-products_en.pdf"},
    {"id":"32941","name":"Presentation - Methodological issues in paediatric trial design","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-methodological-issues-paediatric-trial-design_en.pdf"},
    {"id":"32942","name":"Final assessment report on Echinacea pallida (Nutt.) Nutt., radix - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-08-14T12:00:00Z","last_updated_date":"2018-08-14T12:00:00Z","reference_number":"EMA/HMPC/737379/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-echinacea-pallida-nutt-nutt-radix-revision-1_en.pdf"},
    {"id":"32943","name":"Cilostazol-containing medicines - Article-31 referral - Annex IV (cilostazol)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cilostazol-containing-medicines-article-31-referral-annex-iv-cilostazol_sv.pdf"}},
    {"id":"32944","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 24-27 April 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-04-28T02:09:21Z","last_updated_date":"2006-04-28T02:09:21Z","reference_number":"EMEA/152608/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-24-27-april-2006_en.pdf"},
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    {"id":"32948","name":"Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T00:00:00Z","last_updated_date":"2018-04-20T17:00:00Z","reference_number":"EMA/352178/2013","document_url":"https://www.ema.europa.eu/en/documents/other/points-consider-overall-assessment-supply-shortage-medicinal-product-due-gmp-non-compliance-quality-defects_en.pdf"},
    {"id":"32949","name":"Guideline on the investigation of drug interactions - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T11:41:00Z","last_updated_date":"2015-06-03T17:48:00Z","reference_number":"CPMP/EWP/560/95/Rev.1 Corr.2**","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf"},
    {"id":"32950","name":"EU/3/08/570: Public summary of positive opinion for orphan designation of recombinant human CXCL8 mutant for the prevention of delayed graft function after solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/364246/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308570-public-summary-positive-opinion-orphan-designation-recombinant-human-cxcl8-mutant-prevention-delayed-graft-function-after-solid-organ-transplantation_en.pdf"},
    {"id":"32951","name":"PDCO meeting report 10-12 November 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2010-12-06T01:00:00Z","reference_number":"EMA/PDCO/690063/2010 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-10-12-november-2010_en.pdf"},
    {"id":"32952","name":"Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"EMA/528328/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf"},
    {"id":"32953","name":"Final assessment report on Arnica montana L., flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/HMPC/198794/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-arnica-montana-l-flos_en.pdf"},
    {"id":"32954","name":"Presentation - Central European Pediatric Oncology Early Trial Alliance (CEPOETA) (R. Demlova)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-central-european-pediatric-oncology-early-trial-alliance-cepoeta-r-demlova_en.pdf"},
    {"id":"32955","name":"Recognition criteria for self assessment - Enpr-EMA: EUNETHYDIS (the European Network for Hyperkinetic Disorders)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2011-01-07T00:31:00Z","reference_number":"EMA/632559/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-eunethydis-european-network-hyperkinetic-disorders_en.pdf"},
    {"id":"32956","name":"Draft guideline on the development of medicinal products for the treatment of alcohol dependence","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/CHMP/EWP/20097/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-medicinal-products-treatment-alcohol-dependence_en.pdf"},
    {"id":"32957","name":"Public summary of opinion on orphan designation: Nabilone for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/COMP/924925/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-nabilone-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"32960","name":"CHMP ORGAM agenda for the meeting on 13 March 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-03-28T17:16:00Z","last_updated_date":"2017-03-28T17:16:00Z","reference_number":"EMA/CHMP/174281/2017 Rev.0","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-13-march-2017_en.pdf"},
    {"id":"32961","name":"Committee for veterinary medicinal products: under the chairmanship of Mr S. P. Dean the sixty-fifth meeting of the committee for veterinary medicinal products took place in London on 18-19 April 2001.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-04-19T14:49:21Z","last_updated_date":"2001-04-19T14:49:21Z","reference_number":"EMEA/CVMP/365/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-under-chairmanship-mr-s-p-dean-sixty-fifth-meeting-committee-veterinary-medicinal-products-took-place-london-18-19-april-2001_en.pdf"},
    {"id":"32962","name":"Work programme for the European Medicines Agency 2009","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2009-02-26T00:09:21Z","last_updated_date":"2009-02-26T00:09:21Z","reference_number":"EMEA/87375/2009 Adopted","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-medicines-agency-2009_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/work-programme/work-programme-european-medicines-agency-2009_bg.pdf","es":"https://www.ema.europa.eu/es/documents/work-programme/work-programme-european-medicines-agency-2009_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/work-programme/work-programme-european-medicines-agency-2009_cs.pdf","da":"https://www.ema.europa.eu/da/documents/work-programme/work-programme-european-medicines-agency-2009_da.pdf","de":"https://www.ema.europa.eu/de/documents/work-programme/work-programme-european-medicines-agency-2009_de.pdf","et":"https://www.ema.europa.eu/et/documents/work-programme/work-programme-european-medicines-agency-2009_et.pdf","el":"https://www.ema.europa.eu/el/documents/work-programme/work-programme-european-medicines-agency-2009_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/work-programme/work-programme-european-medicines-agency-2009_fr.pdf","it":"https://www.ema.europa.eu/it/documents/work-programme/work-programme-european-medicines-agency-2009_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/work-programme/work-programme-european-medicines-agency-2009_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/work-programme/work-programme-european-medicines-agency-2009_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/work-programme/work-programme-european-medicines-agency-2009_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/work-programme/work-programme-european-medicines-agency-2009_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/work-programme/work-programme-european-medicines-agency-2009_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/work-programme/work-programme-european-medicines-agency-2009_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/work-programme/work-programme-european-medicines-agency-2009_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/work-programme/work-programme-european-medicines-agency-2009_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/work-programme/work-programme-european-medicines-agency-2009_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/work-programme/work-programme-european-medicines-agency-2009_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/work-programme/work-programme-european-medicines-agency-2009_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/work-programme/work-programme-european-medicines-agency-2009_sv.pdf"}},
    {"id":"32963","name":"Opinion of the Committee on Herbal Medicinal Products on a Community herbal monograph on Cinnamomum verum J.S. Presl, corticis aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2011-08-05T02:00:00Z","reference_number":"EMA/HMPC/258017/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-cinnamomum-verum-js-presl-corticis-aetheroleum_en.pdf"},
    {"id":"32970","name":"CVMP post-authorisation summary of positive opinion for DraxxinII","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-09-09T02:00:00Z","last_updated_date":"2016-09-09T02:00:00Z","reference_number":"EMA/CVMP/586537/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-draxxinii_en.pdf"},
    {"id":"32972","name":"Pre qualification questionnaire - excel format","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-04-28T02:00:00Z","last_updated_date":"2008-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/pre-qualification-questionnaire-excel-format_en.xls"},
    {"id":"32974","name":"Procedure for coordinating pharmacovigilance inspections requested by the CHMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-12T01:00:00Z","last_updated_date":"2014-06-20T02:00:00Z","reference_number":"EMEA/INS/GCP/393141/2005 Superseded","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-coordinating-pharmacovigilance-inspections-requested-chmp_en.pdf"},
    {"id":"32975","name":"Agenda - EudraVigilance Training in 2006, A joint initiative of the EMEA with DIA acting as the conference organiser","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2006-04-11T02:09:21Z","last_updated_date":"2006-04-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eudravigilance-training-2006-joint-initiative-emea-dia-acting-conference-organiser_en.pdf-1"},
    {"id":"32977","name":"Tredaptive, Pelzont and Trevaclyn Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-21T01:00:00Z","last_updated_date":"2012-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tredaptive-pelzont-and-trevaclyn-article-20-procedure-notification_en.pdf"},
    {"id":"32980","name":"Paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-03-26T17:30:00Z","last_updated_date":"2015-03-26T17:30:00Z","reference_number":"EMA/CHMP/206815/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paediatric-addendum-note-guidance-clinical-investigation-medicinal-products-treatment-hypertension_en.pdf"},
    {"id":"32983","name":"Presentation - Development of drugs for bacteremia (Charles Knirsch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-bacteremia-charles-knirsch_en.pdf"},
    {"id":"32987","name":"Committee on herbal medicinal products (HMPC): Meeting report, 7-8 May 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-05-21T02:00:00Z","last_updated_date":"2008-05-21T02:00:00Z","reference_number":"EMEA/HMPC/248007/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-7-8-may-2008_en.pdf"},
    {"id":"32989","name":"CHMP post-authorisation summary of positive opinion for Soliris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/771662/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-soliris_en.pdf-2"},
    {"id":"32990","name":"Cymevene Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-06-21T02:00:00Z","last_updated_date":"2016-06-21T02:00:00Z","reference_number":"EMEA/H/A-30/1406","document_url":"https://www.ema.europa.eu/en/documents/referral/cymevene-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cymevene-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cymevene-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cymevene-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cymevene-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cymevene-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cymevene-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cymevene-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cymevene-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cymevene-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cymevene-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cymevene-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cymevene-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cymevene-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cymevene-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cymevene-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cymevene-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cymevene-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cymevene-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cymevene-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cymevene-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cymevene-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cymevene-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"32993","name":"Day 80 assessment report - Quality guidance rev.12.17","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-09-01T02:09:21Z","last_updated_date":"2017-12-13T17:00:00Z","reference_number":"12.17","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-quality-guidance-rev1217_en.pdf"},
    {"id":"32995","name":"EU/3/16/1674: Public summary of opinion on orphan designation: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19 for treatment i...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2022-04-07T02:00:00Z","reference_number":"EMA/COMP/388379/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161674-public-summary-opinion-orphan-designation-allogeneic-donor-derived-ex-vivo-expanded-t-lymphocytes-transduced-retroviral-vector-containing-inducible-caspase-9-and-truncated-cd19-treatment-i_en.pdf"},
    {"id":"32996","name":"PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T14:00:00Z","last_updated_date":"2013-06-14T14:00:00Z","reference_number":"EMA/349341/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-recommends-suspending-marketing-authorisations-infusion-solutions-containing-hydroxyethyl-starch_en.pdf"},
    {"id":"32997","name":"Superseded assessment report on Ribes nigrum L., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-06-30T02:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"EMA/HMPC/142989/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-ribes-nigrum-l-folium_en.pdf"},
    {"id":"32998","name":"Programme – Focus group with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-06-06T02:00:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"EMA/159266/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-focus-group-invited-stakeholders-field-efficacy-trials-context-eu-authorisation-veterinary-vaccines_en.pdf"},
    {"id":"32999","name":"Standard operating procedure for checking of mock-ups and specimens for new applications and extensions","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-21T02:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"SOP/H/3013","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-checking-mock-ups-and-specimens-new-applications-and-extensions_en.pdf"},
    {"id":"33000","name":"Summary of transfer of appropriations in the budget 2011 - Management Board meeting: 9 June 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMA/MB/371536/2011","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2011-management-board-meeting-9-june-2011_en.pdf"},
    {"id":"33003","name":"Agenda - PRAC draft agenda of meeting 6-9 June 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-06-06T14:30:00Z","last_updated_date":"2017-06-06T14:30:00Z","reference_number":"EMA/PRAC/355498/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-6-9-june-2017_en.pdf"},
    {"id":"33006","name":"Presentation - Objectives of the focus group on non-clinical development of advanced-therapy medicinal products and outcome of discussions in 2011","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T12:00:00Z","last_updated_date":"2012-02-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-objectives-focus-group-non-clinical-development-advanced-therapy-medicinal-products-and-outcome-discussions-2011_en.pdf"},
    {"id":"33009","name":"Ivermectin (all mammalian food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2014-05-20T14:00:00Z","last_updated_date":"2014-05-20T14:00:00Z","reference_number":"EMA/CVMP/294840/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ivermectin-all-mammalian-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"33011","name":"ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answers - Step 5","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2016-02-01T15:53:00Z","reference_number":"EMEA/CHMP/ICH/310133/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e14-clinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-non-antiarrhythmic-drugs-r3-questions-and-answers-step-5_en.pdf"},
    {"id":"33012","name":"Final Community herbal monograph on Commiphora molmol Engler, gummi-resina","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T15:00:00Z","last_updated_date":"2011-12-22T15:00:00Z","reference_number":"EMA/HMPC/96911/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"33013","name":"EU/3/18/1994: Public summary of opinion on orphan designation:\n\nIvosidenib for the treatment of biliary tract cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-08T02:00:00Z","last_updated_date":"2018-05-08T02:00:00Z","reference_number":"EMA/126932/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181994-public-summary-opinion-orphan-designation-ivosidenib-treatment-biliary-tract-cancer_en.pdf"},
    {"id":"33017","name":"Sampling and testing of centrally authorised products: Development of risk based approach for the selection of products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-01-10T01:00:00Z","last_updated_date":"2008-01-10T01:00:00Z","reference_number":"EMEA/INS/S&T/120857/2008","document_url":"https://www.ema.europa.eu/en/documents/other/sampling-and-testing-centrally-authorised-products-development-risk-based-approach-selection-products_en.pdf"},
    {"id":"33019","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations and Healthcare Professionals Working Party joint meeting - February 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-02-05T16:45:00Z","last_updated_date":"2014-04-28T17:45:00Z","reference_number":"EMA/13760/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-and-healthcare-professionals-working-party-joint-meeting-february-2014_en.pdf"},
    {"id":"33020","name":"CHMP post-authorisation summary of positive opinion for Repatha II-17-G","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2018-03-23T13:00:00Z","reference_number":"EMA/CHMP/799799/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-repatha-ii-17-g_en.pdf"},
    {"id":"33021","name":"Start of community reviews - CHMP meeting of 22-25 February 2016","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/147069/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-22-25-february-2016_en.pdf"},
    {"id":"33023","name":"Questions and answers on the referral for Augmentin (amoxicillin and clavulanic acid)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:08:21Z","last_updated_date":"2013-11-18T01:08:21Z","reference_number":"EMEA/CHMP/97898/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-augmentin-amoxicillin-and-clavulanic-acid_sv.pdf"}},
    {"id":"33025","name":"Presentation - Work sharing variations (Gavin Hall)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-work-sharing-variations-gavin-hall_en.pdf"},
    {"id":"33026","name":"Arepanrix: Package leaflet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-29T02:00:00Z","last_updated_date":"2010-03-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/arepanrix-package-leaflet_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/arepanrix-package-leaflet_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/arepanrix-package-leaflet_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/arepanrix-package-leaflet_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/arepanrix-package-leaflet_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/arepanrix-package-leaflet_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/arepanrix-package-leaflet_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/arepanrix-package-leaflet_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/arepanrix-package-leaflet_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/arepanrix-package-leaflet_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/arepanrix-package-leaflet_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/arepanrix-package-leaflet_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/arepanrix-package-leaflet_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/arepanrix-package-leaflet_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/arepanrix-package-leaflet_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/arepanrix-package-leaflet_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/arepanrix-package-leaflet_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/arepanrix-package-leaflet_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/arepanrix-package-leaflet_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/arepanrix-package-leaflet_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/arepanrix-package-leaflet_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/arepanrix-package-leaflet_sv.pdf"}},
    {"id":"33027","name":"PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T13:00:00Z","last_updated_date":"2017-03-10T13:00:00Z","reference_number":"EMA/157486/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-concludes-assessment-gadolinium-agents-used-body-scans-and-recommends-regulatory-actions-including-suspension-some-marketing-authorisations_en.pdf"},
    {"id":"33029","name":"Position paper on the establishment of MRLs for milk considering the daily intake by children","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2002-11-01T01:00:00Z","last_updated_date":"2002-11-01T01:00:00Z","reference_number":"EMEA/CVMP/391/02-FINAL-corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-establishment-mrls-milk-considering-daily-intake-children_en.pdf"},
    {"id":"33030","name":"Hearing the Association of the European Self-Medication Industry during the May 2011 Working Party on Community Monographs and Community List meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-07-20T02:00:00Z","last_updated_date":"2011-07-20T02:00:00Z","reference_number":"EMA/HMPC/407743/2011","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-during-may-2011-working-party-community-monographs-and-community-list-meeting_en.pdf"},
    {"id":"33031","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 8-9 July 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-07-30T15:45:00Z","last_updated_date":"2013-07-30T15:45:00Z","reference_number":"EMA/HMPC/301544/213","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-8-9-july-2013_en.pdf"},
    {"id":"33037","name":"Presentation - Medicines Evaluation Board in the Netherlands: ICH Q3D elemental impurities and ICH M7 mutagenic impurities recent considerations (Diana van Riet-Nales)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-evaluation-board-netherlands-ich-q3d-elemental-impurities-and-ich-m7-mutagenic-impurities-recent-considerations-diana-van-riet-nales_en.pdf"},
    {"id":"33039","name":"Presentation - English version labelling review: overview of the new process for initial MAAs and data from two years experience (Alexios Skarlatos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-16T16:30:00Z","last_updated_date":"2018-01-16T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-english-version-labelling-review-overview-new-process-initial-maas-and-data-two-years-experience-alexios-skarlatos_en.pdf"},
    {"id":"33040","name":"Autologous blood-derived cells filtered to remove other blood components","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2016-05-04T13:00:00Z","reference_number":"EMA/291914/2016","document_url":"https://www.ema.europa.eu/en/documents/report/autologous-blood-derived-cells-filtered-remove-other-blood-components_en.pdf"},
    {"id":"33041","name":"Concept paper on the need for revision of the position paper on compliance of veterinary vaccines with veterinary vaccine monographs of the European pharmacopoeia","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-11-08T01:00:00Z","last_updated_date":"2006-11-08T01:00:00Z","reference_number":"EMEA/CVMP/378570/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-position-paper-compliance-veterinary-vaccines-veterinary-vaccine-monographs-european-pharmacopoeia_en.pdf"},
    {"id":"33042","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Belimumab for treatment of systemic lupus erythematosus","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-11T12:15:00Z","last_updated_date":"2014-12-11T12:15:00Z","reference_number":"EMA/714847/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-belimumab-treatment-systemic-lupus-erythematosus_en.pdf"},
    {"id":"33044","name":"Choice of timetable for type II variations and worksharing applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:52:00Z","last_updated_date":"2020-01-22T18:15:00Z","reference_number":"EMA/103586/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/choice-timetable-type-ii-variations-and-worksharing-applications_en.pdf"},
    {"id":"33045","name":"Agenda – Fifth stakeholders forum on the implementation of the new pharmacovigilance legislation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-05-24T17:22:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"EMA/284201/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fifth-stakeholders-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
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    {"id":"33070","name":"New treatment option for patients with advanced lung cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/329429/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-treatment-option-patients-advanced-lung-cancer_en.pdf"},
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    {"id":"33072","name":"GMP Training Course Quality Control - Lesley Graham","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-20T02:09:21Z","last_updated_date":"2009-10-20T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/gmp-training-course-quality-control-lesley-graham_en.pdf"},
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    {"id":"33076","name":"Registration form - Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-08-16T19:00:00Z","last_updated_date":"2016-08-16T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-committee-advanced-therapies-cat-workshop-scientific-and-regulatory-challenges-genetically-modified-cell-based-cancer-immunotherapy-products_en.docx"},
    {"id":"33078","name":"EU/3/03/159: Public summary of positive opinion for orphan designation of recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 for the treatment of primary growt...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2011-06-21T02:00:00Z","reference_number":"EMEA/COMP/1338/03 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303159-public-summary-positive-opinion-orphan-designation-recombinant-human-insulin-growth-factor-i-recombinant-human-insulin-growth-factor-binding-protein-3-treatment-primary-growt_en.pdf"},
    {"id":"33079","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 4-6 November 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-11-07T01:00:00Z","last_updated_date":"2014-11-07T01:00:00Z","reference_number":"EMA/CVMP/651488/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-4-6-november-2014_en.pdf"},
    {"id":"33080","name":"CVMP assessment report regarding the request for an opinion under Article 30(3) of Regulation (EC) No. 726/2004 in relation to the potential risk for the consumer resulting from the use of diethanolamine as an excipient ...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T12:27:00Z","last_updated_date":"2018-07-25T12:27:00Z","reference_number":"EMA/CVMP/468348/2018","document_url":"https://www.ema.europa.eu/en/documents/report/cvmp-assessment-report-regarding-request-opinion-under-article-303-regulation-ec-no-7262004-relation-potential-risk-consumer-resulting-use-diethanolamine-excipient_en.pdf"},
    {"id":"33081","name":"Questions and answers on Mifepristone Linepharma and associated names (mifepristone, 200-mg tablet)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T14:00:00Z","last_updated_date":"2013-01-03T13:00:00Z","reference_number":"EMA/410788/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-mifepristone-linepharma-and-associated-names-mifepristone-200-mg-tablet_sv.pdf"}},
    {"id":"33082","name":"Presentation - Crizotinib in patients with ROS1+ non-small cell lung cancer: rationale and results (Mace L. Rothenberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T02:00:00Z","last_updated_date":"2016-08-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-crizotinib-patients-ros1-non-small-cell-lung-cancer-rationale-and-results-mace-l-rothenberg_en.pdf"},
    {"id":"33084","name":"Pandemrix: Product information as recommended by the CHMP on 22 April 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2010-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pandemrix-product-information-recommended-chmp-22-april-2010_en.pdf"},
    {"id":"33086","name":"Diclofenac Article-31 referral - Annex I","type":"referral","status":"Draft","consultation_date":"","first_published_date":"2012-10-31T18:00:00Z","last_updated_date":"2013-11-27T11:00:00Z","reference_number":"EMA/704684/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diclofenac-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diclofenac-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diclofenac-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diclofenac-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diclofenac-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diclofenac-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diclofenac-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diclofenac-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/diclofenac-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diclofenac-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diclofenac-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diclofenac-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diclofenac-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diclofenac-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diclofenac-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diclofenac-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diclofenac-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diclofenac-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diclofenac-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diclofenac-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diclofenac-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diclofenac-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/diclofenac-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/diclofenac-article-31-referral-annex-i_no.pdf"}},
    {"id":"33087","name":"Presentation - PK-PD target selection: it’s all about the goal (Paul Ambrose)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pk-pd-target-selection-its-all-about-goal-paul-ambrose_en.pdf"},
    {"id":"33088","name":"Betamethasone: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-06-01T02:00:00Z","last_updated_date":"1999-06-01T02:00:00Z","reference_number":"EMEa/MRL/605/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/betamethasone-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33089","name":"Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2013)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-10-08T15:00:00Z","last_updated_date":"2014-10-08T15:00:00Z","reference_number":"EMA/103410/2014","document_url":"https://www.ema.europa.eu/en/documents/report/annual-report-european-medicines-agencys-interaction-patients-consumers-healthcare-professionals-and-their-organisations-2013_en.pdf"},
    {"id":"33091","name":"Presentation - Development of drugs for bacteraemia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:50Z","last_updated_date":"2011-04-26T18:05:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-bacteraemia_en.pdf"},
    {"id":"33093","name":"Overview of comments received on guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products-Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/HMPC/669906/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-revision-2_en.pdf"},
    {"id":"33094","name":"Hearing AESGP - 6 May 2008: Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-07-09T02:00:00Z","last_updated_date":"2008-07-09T02:00:00Z","reference_number":"EMEA/HMPC/348341/2008","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-aesgp-6-may-2008-report_en.pdf"},
    {"id":"33098","name":"Presentation - Session 1: Nonclinical Models: proof of concept (Jan Willem van der Laan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-nonclinical-models-proof-concept-jan-willem-van-der-laan_en.pdf"},
    {"id":"33099","name":"Zydelig Article-20 procedure - Assessment report on provisional measures","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-03-23T01:00:00Z","last_updated_date":"2016-03-23T01:00:00Z","reference_number":"EMA/215033/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-assessment-report-provisional-measures_en.pdf"},
    {"id":"33101","name":"EU/3/01/037 : Public summary of positive opinion for orphan designation of humanised anti-HM1.24 monoclonal antibody for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-04-28T02:00:00Z","last_updated_date":"2005-04-28T02:00:00Z","reference_number":"EMEA/COMP/11030/03","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301037-public-summary-positive-opinion-orphan-designation-humanised-anti-hm124-monoclonal-antibody-treatment-multiple-myeloma_en.pdf"},
    {"id":"33106","name":"Important information for Tenderers intending to bid for Lots 1 and 2","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-16T02:00:00Z","last_updated_date":"2008-07-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/important-information-tenderers-intending-bid-lots-1-and-2_en.pdf"},
    {"id":"33107","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 24 to 26 June 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-06-27T02:09:21Z","last_updated_date":"2003-06-27T02:09:21Z","reference_number":"EMEA/16832/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-24-26-june-2003_en.pdf"},
    {"id":"33109","name":"Questions and answers on Flolan and associated names (epoprostenol, 0.5 and 1.5 mg powder for solution for infusion)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T14:00:00Z","last_updated_date":"2012-09-14T14:00:00Z","reference_number":"EMA/CHMP/329168/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-flolan-and-associated-names-epoprostenol-05-and-15-mg-powder-solution-infusion_sv.pdf"}},
    {"id":"33110","name":"Omega-3 acid ethyl esters - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2019-03-06T14:00:00Z","reference_number":"EMA/CHMP/171344/2018 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-timetable-procedure_en.pdf"},
    {"id":"33111","name":"Opinion of the CVMP on the establishment of maximum residue limits: Purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids (as potassium salts)","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-02-17T17:30:00Z","last_updated_date":"2016-02-17T17:30:00Z","reference_number":"EMA/CVMP/245930/2015","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-purified-semi-solid-extract-humulus-lupulus-l-containing-approximately-48-beta-acids-potassium-salts_en.pdf"},
    {"id":"33112","name":"EU/3/01/051: Public summary of positive opinion for orphan designation\n\nof 1,3-propanedisulfonic acid, disodium salt for the treatment of systemic secondary amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2013-09-19T02:00:00Z","reference_number":"EMEA/COMP/249/04 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301051-public-summary-positive-opinion-orphan-designation-13-propanedisulfonic-acid-disodium-salt-treatment-systemic-secondary-amyloidosis_en.pdf"},
    {"id":"33116","name":"New medicine for rare inflammatory condition of the oesophagus","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2017-11-10T01:00:00Z","reference_number":"EMA/734285/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-rare-inflammatory-condition-oesophagus_en.pdf"},
    {"id":"33118","name":"eCTD/Nees impact on the centralised procedure Goeffrey Williams - Roche","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ectdnees-impact-centralised-procedure-goeffrey-williams-roche_en.pdf"},
    {"id":"33119","name":"Withdrawal letter : Abilify","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-01-05T01:00:00Z","last_updated_date":"2010-01-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-abilify_en.pdf"},
    {"id":"33121","name":"Diacerein Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/diacerein-article-31-referral-notification_en.pdf"},
    {"id":"33124","name":"Dimetridazole: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-15T02:00:00Z","last_updated_date":"1996-05-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dimetridazole-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33125","name":"CHMP post-authorisation summary of positive opinion for Prevenar 13","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-05-30T02:00:00Z","last_updated_date":"2013-05-30T02:00:00Z","reference_number":"EMA/CHMP/327906/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prevenar-13_en.pdf-0"},
    {"id":"33129","name":"Tianeptine: List of nationally authorised medicinal products - PSUSA/00002943/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-08T11:47:00Z","last_updated_date":"2016-10-19T12:50:10Z","reference_number":"EMA/179740/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/tianeptine-list-nationally-authorised-medicinal-products-psusa00002943201506_en.pdf"},
    {"id":"33130","name":"EU/3/07/513: Public summary of positive opinion for orphan designation of (S)-2-nitro-6-(4-trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b] [1,3] oxazine for the treatment of tuberculosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2008-07-02T02:00:00Z","reference_number":"EMEA/COMP/489102/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307513-public-summary-positive-opinion-orphan-designation-s-2-nitro-6-4-trifluoromethoxybenzyloxy-67-dihydro-5h-imidazo21-b-13-oxazine-treatment-tuberculosis_en.pdf"},
    {"id":"33133","name":"Superseded overview of comments received on Community herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/46410/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-revision-1_en.pdf"},
    {"id":"33134","name":"Overview of comments received by EMA on 'Draft ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b' - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-02-13T01:00:00Z","last_updated_date":"2017-02-13T01:00:00Z","reference_number":"EMA/605292/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ema-draft-ich-guideline-e17-general-principles-planning-and-design-multi-regional-clinical-trials-step-2b-first-version_en.pdf"},
    {"id":"33136","name":"EU/3/08/534: Public summary of positive opinion for orphan designation of allogeneic human umbilical cord tissue-derived cells for treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/48111/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308534-public-summary-positive-opinion-orphan-designation-allogeneic-human-umbilical-cord-tissue-derived-cells-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"33137","name":"Technical specifications for open invitation to tender: Procurement procedure EMA/2014/49/AUD","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2014-12-10T10:00:00Z","last_updated_date":"2014-12-10T10:00:00Z","reference_number":"EMA/564159/2014","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-open-invitation-tender-procurement-procedure-ema201449aud_en.pdf"},
    {"id":"33139","name":"EU/3/11/893: Public summary of opinion on orphan designation: Cardiotrophin-1 for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-09-21T02:00:00Z","last_updated_date":"2011-09-21T02:00:00Z","reference_number":"EMA/COMP/512020/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311893-public-summary-opinion-orphan-designation-cardiotrophin-1-treatment-acute-liver-failure_en.pdf"},
    {"id":"33140","name":"Guido Rasi takes office as head of EMA","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-11-16T01:00:00Z","last_updated_date":"2015-11-16T01:00:00Z","reference_number":"EMA/747097/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/guido-rasi-takes-office-head-ema_en.pdf"},
    {"id":"33141","name":"Sodium glycerophosphate: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-11-01T01:00:00Z","last_updated_date":"1998-11-01T01:00:00Z","reference_number":"EMEA/MRL/522/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/sodium-glycerophosphate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33142","name":"Tibolone: List of nationally authorised medicinal products - PSUSA/00002947/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-04T18:30:00Z","last_updated_date":"2017-09-04T18:30:00Z","reference_number":"EMA/578102/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tibolone-list-nationally-authorised-medicinal-products-psusa00002947201612_en.pdf"},
    {"id":"33144","name":"Annex 8 Standard Timesheet - Procurement Procedure EMA/2012/09/IF","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-8-standard-timesheet-procurement-procedure-ema201209if_en.pdf"},
    {"id":"33146","name":"Minutes of European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)task force meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2015-10-29T16:00:00Z","last_updated_date":"2015-10-29T16:00:00Z","reference_number":"EMA/645750/2015","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-international-organization-standardization-iso-identification-medicinal-products-idmptask-force-meeting_en.pdf"},
    {"id":"33148","name":"Update on infringement procedure against Roche Registration Ltd.","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-14T02:00:00Z","last_updated_date":"2014-04-14T02:00:00Z","reference_number":"EMA/211922/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-infringement-procedure-against-roche-registration-ltd_en.pdf"},
    {"id":"33155","name":"Prevora - Article 29 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-09-20T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/prevora-article-29-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/prevora-article-29-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/prevora-article-29-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/prevora-article-29-referral-annex-i_cs.pdf","de":"https://www.ema.europa.eu/de/documents/referral/prevora-article-29-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/prevora-article-29-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/prevora-article-29-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/prevora-article-29-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/prevora-article-29-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/prevora-article-29-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/prevora-article-29-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/prevora-article-29-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/prevora-article-29-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/prevora-article-29-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/prevora-article-29-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/prevora-article-29-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/prevora-article-29-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/prevora-article-29-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/prevora-article-29-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/prevora-article-29-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/prevora-article-29-referral-annex-i_sv.pdf"}},
    {"id":"33160","name":"Public statement on the increased risk of serious infection and neutropenia in patients treated concurrently with Kineret (anakinra) and Enbrel (etanercept)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2003-02-05T01:00:00Z","last_updated_date":"2003-02-05T01:00:00Z","reference_number":"EMEA/31631/02","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-increased-risk-serious-infection-and-neutropenia-patients-treated-concurrently-kineret-anakinra-and-enbrel-etanercept_en.pdf"},
    {"id":"33161","name":"Form 1: For marketing-authorisation holders when submitting translation to the national competent authority of Croatia","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2013-03-15T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/form-1-marketing-authorisation-holders-when-submitting-translation-national-competent-authority-croatia_en.doc"},
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    {"id":"33165","name":"Overview of comments received on 'draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease' (EMA/CPMP/EWP/2284/99 Rev. 2)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T11:44:58Z","last_updated_date":"2018-07-23T11:44:58Z","reference_number":"EMA/CHMP/261409/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-development-new-medicinal-products-treatment-crohns-disease-emacpmpewp228499-rev-2_en.pdf"},
    {"id":"33167","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T14:00:00Z","last_updated_date":"2016-04-06T14:00:00Z","reference_number":"EMA/191606/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-march-2016_en.pdf"},
    {"id":"33170","name":"Standard operating procedure for co-ordination of GCP inspections","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-05-16T02:00:00Z","last_updated_date":"2012-09-27T02:00:00Z","reference_number":"SOP/INSP/2020","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-co-ordination-gcp-inspections_en.pdf"},
    {"id":"33171","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Dinutuximab beta Apeiron (dinutuximab beta) for the treatment of neuroblastoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2017-05-24T02:00:00Z","last_updated_date":"2017-05-24T02:00:00Z","reference_number":"EMA/228978/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-dinutuximab-beta-apeiron-dinutuximab-beta-treatment-neuroblastoma_en.pdf"},
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    {"id":"33173","name":"Flupirtine-containing medicines Article-107i procedure - Divergent positions to CMDh position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T14:00:00Z","last_updated_date":"2013-07-18T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-divergent-positions-cmdh-position_en.pdf"},
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    {"id":"33176","name":"Guideline on epidemiological data on blood transmissible infections - For inclusion in the Guideline on the Scientific data requirements for a Plasma Master File (EMEA/CPMP/BWP/3794/03)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-01-20T01:00:00Z","last_updated_date":"2005-01-20T01:00:00Z","reference_number":"EMEA/CPMP/BWP/125/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-epidemiological-data-blood-transmissible-infections-inclusion-guideline-scientific-data-requirements-plasma-master-file-emeacpmpbwp379403_en.pdf"},
    {"id":"33177","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T13:00:00Z","last_updated_date":"2017-02-24T13:00:00Z","reference_number":"EMA/118223/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-sglt2-inhibitors-information-potential-risk-toe-amputation-be-included-prescribing-information_en.pdf"},
    {"id":"33179","name":"CHMP summary of positive opinion for Inflectra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/CHMP/364710/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-inflectra_en.pdf"},
    {"id":"33180","name":"CHMP summary of positive opinion for Pioglitazone Teva Pharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2022-08-30T17:10:00Z","reference_number":"EMA/CHMP/756105/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pioglitazone-teva-pharma_en.pdf"},
    {"id":"33182","name":"Twentieth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-12-03T01:00:00Z","last_updated_date":"1998-12-03T01:00:00Z","reference_number":"EMEA/MB/045/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/twentieth-meeting-management-board_en.pdf"},
    {"id":"33183","name":"Report on second workshop of the European Paediatric Research Network (EnprEMA)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"EMA/205816/2010","document_url":"https://www.ema.europa.eu/en/documents/report/report-second-workshop-european-paediatric-research-network-enprema_en.pdf"},
    {"id":"33188","name":"European Medicines Agency’s Management Board endorses the work programme 2010 and strengthens the involvement of patients in the work of the Agency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-12-17T00:09:21Z","last_updated_date":"2009-12-17T00:09:21Z","reference_number":"EMA/808539/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-endorses-work-programme-2010-and-strengthens-involvement-patients-work-agency_en.pdf"},
    {"id":"33190","name":"Agenda - CAT agenda for the written procedure - 7-11 August 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-08-11T19:17:00Z","last_updated_date":"2017-08-11T19:17:00Z","reference_number":"EMA/CAT/518173/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-written-procedure-7-11-august-2017_en.pdf"},
    {"id":"33193","name":"EU/3/08/595: Public summary of positive opinion for orphan designation of monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E for the treatment of anaplastic large cell lympho...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMEA/COMP/547229/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308595-public-summary-positive-opinion-orphan-designation-monoclonal-antibody-against-human-cd30-covalently-linked-cytotoxin-monomethylauristatin-e-treatment-anaplastic-large-cell-lympho_en.pdf"},
    {"id":"33195","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - April 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-04-26T11:30:00Z","last_updated_date":"2012-04-26T11:30:00Z","reference_number":"EMA/CHMP/PhVWP/262424/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-april-2012_en.pdf"},
    {"id":"33196","name":"Presentation - In focus – The paediatric PAH population clinicians perspectives (M.Beghetti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-paediatric-pah-population-clinicians-perspectives-mbeghetti_en.pdf"},
    {"id":"33197","name":"Presentation - Update on the follow up actions from the Risk Minimisation Measures Workshop in 2015 (Jamie Wilkinson)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/presentation-update-follow-actions-risk-minimisation-measures-workshop-2015-jamie-wilkinson_en.pdf"},
    {"id":"33198","name":"Experimental Ebola treatments still at early stage of development","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-16T11:00:00Z","last_updated_date":"2014-12-16T11:00:00Z","reference_number":"EMA/733055/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/experimental-ebola-treatments-still-early-stage-development_en.pdf"},
    {"id":"33199","name":"EU/3/09/654: Public summary of positive opinion for orphan designation of hypothiocyanite / lactoferrin for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-11T02:00:00Z","last_updated_date":"2013-03-19T13:30:00Z","reference_number":"EMA/COMP/392984/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309654-public-summary-positive-opinion-orphan-designation-hypothiocyanite-lactoferrin-treatment-cystic-fibrosis_en.pdf"},
    {"id":"33201","name":"Guideline on similar biological medicinal products containing interferon beta","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-03-06T12:00:02Z","last_updated_date":"2013-03-06T12:00:02Z","reference_number":"EMA/CHMP/BMWP/652000/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-interferon-beta_en.pdf"},
    {"id":"33203","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector containing the FANCA gene","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-08-23T17:00:00Z","last_updated_date":"2018-08-23T17:00:00Z","reference_number":"EMA/496459/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cd34-cells-transduced-lentiviral-vector-containing-fanca-gene_en.pdf"},
    {"id":"33204","name":"GVK Biosciences Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2015-04-10T16:19:00Z","reference_number":"EMA/591005/2014 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"33205","name":"Clavulanic acid: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-02-01T01:00:00Z","last_updated_date":"2001-02-01T01:00:00Z","reference_number":"EMEA/MRL/776/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/clavulanic-acid-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33208","name":"Presentation - HIV and FDC: aspects of two guidelines (Filip Josephson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-05T17:00:00Z","last_updated_date":"2016-01-05T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hiv-and-fdc-aspects-two-guidelines-filip-josephson_en.pdf"},
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    {"id":"33210","name":"Cyproterone / ethinylestradiol-containing medicines: Article-107i procedure - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-10T15:00:00Z","last_updated_date":"2013-06-10T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cyproterone-ethinylestradiol-containing-medicines-article-107i-procedure-annex-ii_sv.pdf"}},
    {"id":"33211","name":"EU/3/12/1066: Public summary of opinion on orphan designation: Tafamidis for treatment of senile systemic amyloidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T01:00:00Z","last_updated_date":"2012-12-12T01:00:00Z","reference_number":"EMA/COMP/678671/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121066-public-summary-opinion-orphan-designation-tafamidis-treatment-senile-systemic-amyloidosis_en.pdf"},
    {"id":"33213","name":"Update on revision of chapters 3 and 5 of the good-manufacturing-practice guide: Dedicated facilities","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-12-10T01:00:00Z","last_updated_date":"2009-12-10T01:00:00Z","reference_number":"EMA/INS/GMP/809387/2009","document_url":"https://www.ema.europa.eu/en/documents/report/update-revision-chapters-3-and-5-good-manufacturing-practice-guide-dedicated-facilities_en.pdf"},
    {"id":"33214","name":"Presentation - Good practice guide on medication errors – Highlights and EU regulatory initiatives (Thomas Goedecke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-practice-guide-medication-errors-highlights-and-eu-regulatory-initiatives-thomas-goedecke_en.pdf"},
    {"id":"33215","name":"Questions and answers on the withdrawal of the marketing authorisation application for Elmisol (levamisole)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"EMA/CHMP/380586/2017","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-elmisol-levamisole_sv.pdf"}},
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    {"id":"33219","name":"Committee for Advanced Therapies (CAT): April 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-06T02:00:00Z","last_updated_date":"2011-07-07T02:00:00Z","reference_number":"EMA/CAT/328232/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-april-2011-meeting-monthly-report_en.pdf"},
    {"id":"33220","name":"EU/3/15/1490: Public summary of opinion on orphan designation: Triamcinolone acetonide for the treatment of non-infectious uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/COMP/281345/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151490-public-summary-opinion-orphan-designation-triamcinolone-acetonide-treatment-non-infectious-uveitis_en.pdf"},
    {"id":"33222","name":"Qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-10-03T17:50:00Z","last_updated_date":"2013-10-03T17:50:00Z","reference_number":"EMA/CHMP/SAWP/567188/2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-novel-data-driven-model-disease-progression-and-trial-evaluation-mild-and-moderate-alzheimers-disease_en.pdf"},
    {"id":"33223","name":"Questions and answers on the referral for Mephatrim trimetazidine 35 mg modified-release tablets","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-01-22T00:08:21Z","last_updated_date":"2009-01-22T00:08:21Z","reference_number":"EMEA/45405/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-mephatrim-trimetazidine-35-mg-modified-release-tablets_en.pdf"},
    {"id":"33224","name":"Standard operating procedure for handover file","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-22T14:30:00Z","last_updated_date":"2013-03-26T18:00:00Z","reference_number":"SOP/EMA/0127","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-handover-file_en.pdf"},
    {"id":"33226","name":"Opinion of the HMPC on a European Union herbal monograph on Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/HMPC/292904/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus_en.pdf"},
    {"id":"33228","name":"Article-31 referral - European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2014-03-06T01:00:00Z","reference_number":"EMA/706409/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/article-31-referral-european-medicines-agency-recommends-restricting-use-thiocolchicoside-mouth-or-injection_sv.pdf"}},
    {"id":"33229","name":"EU/3/05/310: Public summary of positive opinion for orphan designation of treprostinil diethanolamine (oral use) for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/COMP/221562/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305310-public-summary-positive-opinion-orphan-designation-treprostinil-diethanolamine-oral-use-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"33232","name":"EU/3/16/1699: Public summary of opinion on orphan designation: Mifamurtide for the treatment of echinococcosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2016-09-06T02:00:00Z","reference_number":"EMA/COMP/448143/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161699-public-summary-opinion-orphan-designation-mifamurtide-treatment-echinococcosis_en.pdf"},
    {"id":"33233","name":"Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-14T10:36:00Z","last_updated_date":"2017-03-14T10:47:00Z","reference_number":"EMA/173834/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gynaecological-indication-labour-induction-list-nationally-authorised-medicinal-products-psusa00010353201605_en.pdf"},
    {"id":"33235","name":"Report from the joint EMEA(NRG)/EFPIA workshop on invented names","type":"report","status":"unknown","consultation_date":"","first_published_date":"2006-11-30T00:09:21Z","last_updated_date":"2006-11-30T00:09:21Z","reference_number":"EMEA/487680/2006","document_url":"https://www.ema.europa.eu/en/documents/report/report-joint-emeanrgefpia-workshop-invented-names_en.pdf"},
    {"id":"33237","name":"Pre-Qualification Questionnaire (PQQ) for a restricted tender procedure organised by European Medicines Agency (EMEA) cashless payment system EMEA/2008/63/ISERV","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:21Z","last_updated_date":"2008-11-25T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure-organised-european-medicines-agency-emea-cashless-payment-system-emea200863iserv_en.doc"},
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    {"id":"33241","name":"Xylazine hydrochloride: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-06-01T02:00:00Z","last_updated_date":"1999-06-01T02:00:00Z","reference_number":"EMEA/MRL/611/99-FINAL-corrigendum","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/xylazine-hydrochloride-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33242","name":"EU/3/12/1083 : Public summary of opinion on orphan designation: Humanised single-chain monoclonal antibody against CD37 for the treatment chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2013-07-08T13:00:00Z","reference_number":"EMA/COMP/741023/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121083-public-summary-opinion-orphan-designation-humanised-single-chain-monoclonal-antibody-against-cd37-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
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    {"id":"33244","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous expanded viable chondrocytes combined with a three dimensional structure (biphasic collagen scaffold)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-22T12:00:00Z","last_updated_date":"2016-03-22T12:00:00Z","reference_number":"EMA/556423/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-expanded-viable-chondrocytes-combined-three-dimensional-structure-biphasic-collagen-scaffold_en.pdf"},
    {"id":"33247","name":"European Union recommendations for the seasonal-influenza-vaccine composition for the season 2009 / 2010","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:09:21Z","last_updated_date":"2009-04-23T02:09:21Z","reference_number":"EMEA/CHMP/BWP/133895/2009/Rev 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-recommendations-seasonal-influenza-vaccine-composition-season-2009-2010_en.pdf"},
    {"id":"33248","name":"Presentation - Indications and endpoints for complicated skin and soft-tissue infections","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:47Z","last_updated_date":"2011-04-26T18:05:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-indications-and-endpoints-complicated-skin-and-soft-tissue-infections_en.pdf"},
    {"id":"33251","name":"Final European Union herbal monograph on Carum carvi L., fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-09-10T02:00:00Z","last_updated_date":"2015-09-10T02:00:00Z","reference_number":"EMA/HMPC/715092/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-carum-carvi-l-fructus_en.pdf"},
    {"id":"33252","name":"Overview of comments received on draft guideline on quality of combination herbal medicinal products/traditional herbal medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-06-23T02:00:00Z","last_updated_date":"2008-06-23T02:00:00Z","reference_number":"EMEA/HMPC/559281/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-quality-combination-herbal-medicinal-productstraditional-herbal-medicinal-products_en.pdf"},
    {"id":"33254","name":"Scientific recommendation on classification of advanced therapy medicinal products: Request form and briefing information Article 17 - Regulation (EC) No 1394/2007","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-05-26T03:00:00Z","last_updated_date":"2011-03-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/scientific-recommendation-classification-advanced-therapy-medicinal-products-request-form-and-briefing-information-article-17-regulation-ec-no-13942007_en.doc"},
    {"id":"33256","name":"Summary of transfer of appropriations in the budget 2015 - Management Board meeting: 11 June 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T12:00:00Z","last_updated_date":"2015-06-16T12:00:00Z","reference_number":"EMA/MB/279870/2015","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2015-management-board-meeting-11-june-2015_en.pdf"},
    {"id":"33258","name":"Note for guidance on the clinical investigation of medicinal products in the treatment of Asthma","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-11-21T01:00:00Z","last_updated_date":"2002-11-21T01:00:00Z","reference_number":"CHMP/EWP/2922/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-asthma_en.pdf"},
    {"id":"33259","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Passiflora incarnata L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2007-09-03T02:09:21Z","last_updated_date":"2007-09-03T02:09:21Z","reference_number":"EMEA/HMPC/405535/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-passiflora-incarnata-l-herba_en.pdf"},
    {"id":"33260","name":"EU/3/12/1095: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 9 containing the human N-acetylglucosaminidase-alpha gene for the treatment of mucopolysaccharidosis type IIIB (Sanfil...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"EMA/COMP/805822/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121095-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-containing-human-n-acetylglucosaminidase-alpha-gene-treatment-mucopolysaccharidosis-type-iiib-sanfil_en.pdf"},
    {"id":"33261","name":"Overview of comments received on 'Reflection paper on viral safety of plasma-derived medicinal products with respect to Hepatitis E virus’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-06-27T12:10:00Z","last_updated_date":"2016-06-27T12:10:00Z","reference_number":"EMA/CHMP/BWP/744742/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-viral-safety-plasma-derived-medicinal-products-respect-hepatitis-e-virus_en.pdf"},
    {"id":"33264","name":"EU/3/09/614: Public summary of positive opinion for orphan designation of mifepristone for the treatment of endogenous hypercortisolism (Cushing’s syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/50998/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309614-public-summary-positive-opinion-orphan-designation-mifepristone-treatment-endogenous-hypercortisolism-cushings-syndrome_en.pdf"},
    {"id":"33265","name":"Valtrex Article-30 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2011-09-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valtrex-article-30-referral-annex-i-ii-iii_sv.pdf"}},
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    {"id":"33269","name":"EU/3/14/1334: Public summary of opinion on orphan designation: (3S)-(+)-(5-Chloro-2-methoxyphenyl)-1,3-dihydro-3-fluoro-6-(trifluoromethyl)-2H-indol-2-one for the treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/555975/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141334-public-summary-opinion-orphan-designation-3s-5-chloro-2-methoxyphenyl-13-dihydro-3-fluoro-6-trifluoromethyl-2h-indol-2-one-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"33270","name":"EU/3/09/686: Public summary of positive opinion for orphan designation of NGR-human tumour necrosis factor for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-11-18T00:09:21Z","last_updated_date":"2009-11-18T00:09:21Z","reference_number":"EMEA/COMP/577663/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309686-public-summary-positive-opinion-orphan-designation-ngr-human-tumour-necrosis-factor-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"33273","name":"Presentation - Feedback from CAT (K. Breen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-cat-k-breen-ema_en.pdf"},
    {"id":"33274","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-06-11T17:00:00Z","last_updated_date":"2014-06-11T17:00:00Z","reference_number":"EMA/286257/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-may-2014_en.pdf"},
    {"id":"33275","name":"Questions and answers on recommendation for the refusal of the marketing authorisation for  Mylotarg","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T00:09:21Z","last_updated_date":"2008-01-24T00:09:21Z","reference_number":"EMEA/37537/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-mylotarg_en.pdf"},
    {"id":"33277","name":"Scientific advice and protocol assistance - Adopted during the CHMP meeting 12–15 November 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T12:59:00Z","last_updated_date":"2012-11-16T12:59:00Z","reference_number":"EMA/CHMP/SAWP/732749/2012","document_url":"https://www.ema.europa.eu/en/documents/other/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-12-15-november-2012_en.pdf"},
    {"id":"33278","name":"EU/3/18/2005: Public summary of opinion on orphan designation: Tazemetostat for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-15T02:00:00Z","last_updated_date":"2018-05-15T02:00:00Z","reference_number":"EMA/111729/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182005-public-summary-opinion-orphan-designation-tazemetostat-treatment-follicular-lymphoma_en.pdf"},
    {"id":"33280","name":"Committee for medicinal products for veterinary use: Meeting of 14 to 16 March 2006","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-17T12:29:21Z","last_updated_date":"2006-03-17T12:29:21Z","reference_number":"EMEA/CVMP/66758/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-14-16-march-2006_en.pdf"},
    {"id":"33284","name":"EU/3/14/1270: Public summary of opinion on orphan designation of(5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-10T02:00:00Z","last_updated_date":"2014-07-10T02:00:00Z","reference_number":"EMA/COMP/234508/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141270-public-summary-opinion-orphan-designation-of5r5ar8ar9s-9-46-o-r-ethylidene-i2-d-glucopyranosyl-oxy-5-4-22-dimethyl-13-dioxolan-4-ylmethoxycarbonyloxy-35-dimethoxyphenyl-58_en.pdf"},
    {"id":"33286","name":"EU/3/10/820: Public summary of opinion on orphan designation: Human heterologous liver cells (for infusion) for the treatment of argininosuccinic aciduria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"EMA/COMP/636096/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310820-public-summary-opinion-orphan-designation-human-heterologous-liver-cells-infusion-treatment-argininosuccinic-aciduria_en.pdf"},
    {"id":"33287","name":"EU/3/12/974: Public summary of opinion on orphan designation: Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate aminotransferase gene for the treatment of primary hyperoxaluria type 1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-19T11:45:00Z","last_updated_date":"2013-03-11T14:00:00Z","reference_number":"EMA/64512/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312974-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-5-containing-human-alanine-glyoxylate-aminotransferase-gene-treatment-primary-hyperoxaluria-type-1_en.pdf"},
    {"id":"33288","name":"Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0003","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-02-23T19:31:00Z","last_updated_date":"2017-02-23T19:31:00Z","reference_number":"EMA/101714/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproteroneethinylestradiol-prac-non-interventional-imposed-pass-final-study-report-assessment-report-emeahnpsrj0003_en.pdf"},
    {"id":"33289","name":"EU/3/01/031: Public summary of positive opinion for orphan designation of arsenic trioxide for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-04T02:00:00Z","last_updated_date":"2010-03-15T01:00:00Z","reference_number":"EMEA/COMP/118/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301031-public-summary-positive-opinion-orphan-designation-arsenic-trioxide-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"33290","name":"European Medicines Agency recommends approval of a new medicine for multidrug-resistant tuberculosis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T01:00:00Z","last_updated_date":"2013-12-20T01:00:00Z","reference_number":"EMA/794261/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-new-medicine-multidrug-resistant-tuberculosis_en.pdf"},
    {"id":"33291","name":"Presentation - FDA pilot project to develop a clinical database to examine safety in trials using CAR T-cells (Maura O’Leary)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-pilot-project-develop-clinical-database-examine-safety-trials-using-car-t-cells-maura-oleary_en.pdf"},
    {"id":"33292","name":"Committee for medicinal products for human use  summary of positive opinion  for Zylagren","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-24T02:00:00Z","last_updated_date":"2009-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-zylagren_en.pdf"},
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    {"id":"33301","name":"2006 EU-Swiss GMP China Training Workshop - Announcement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-07-05T02:09:21Z","last_updated_date":"2006-07-05T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/2006-eu-swiss-gmp-china-training-workshop-announcement_en.pdf"},
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    {"id":"33303","name":"Numeta Article-107i procedure - Amendments to relevant sections of the summary of product characteristics and package leaflet","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-amendments-relevant-sections-summary-product-characteristics-and-package-leaflet_en.pdf"},
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    {"id":"33316","name":"Arimidex - Article 30 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/arimidex-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/arimidex-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/arimidex-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/arimidex-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/arimidex-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/arimidex-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/arimidex-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/arimidex-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/arimidex-article-30-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/arimidex-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/arimidex-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/arimidex-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/arimidex-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/arimidex-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/arimidex-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/arimidex-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/arimidex-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/arimidex-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/arimidex-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/arimidex-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/arimidex-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/arimidex-article-30-referral-annex-i_sv.pdf"}},
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    {"id":"33321","name":"Presentation - Public Private Partnerships as funders, Hugh Laverty","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-private-partnerships-funders-hugh-laverty_en.pdf"},
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    {"id":"33323","name":"EU/3/16/1770: Public summary of positive opinion for orphan designation of 5-[4-[2-(5-(1-hydroxyethyl)-2-pyridinyl)ethoxy]benzyl]-2,4-thiazolidinedione hydrochloride for the treatment of adrenoleukodystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2016-12-13T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161770-public-summary-positive-opinion-orphan-designation-5-4-2-5-1-hydroxyethyl-2-pyridinylethoxybenzyl-24-thiazolidinedione-hydrochloride-treatment-adrenoleukodystrophy_en.pdf"},
    {"id":"33326","name":"Framework for interaction between the European Medicines Agency and healthcare professionals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T11:56:00Z","last_updated_date":"2011-12-19T11:56:00Z","reference_number":"EMA/688885/2010","document_url":"https://www.ema.europa.eu/en/documents/other/framework-interaction-between-european-medicines-agency-and-healthcare-professionals_en.pdf"},
    {"id":"33328","name":"Comments from the public consultation on the revised priority list of off-patent medicines for children 2013/14","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-12T18:00:00Z","last_updated_date":"2013-08-12T18:00:00Z","reference_number":"EMA/443893/2013","document_url":"https://www.ema.europa.eu/en/documents/other/comments-public-consultation-revised-priority-list-patent-medicines-children-201314_en.pdf"},
    {"id":"33329","name":"Ex ante publicity of a negotiated procedure: managed services consultancy","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-02-09T11:00:00Z","last_updated_date":"2016-02-09T11:00:00Z","reference_number":"EMA/59027/2016","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-managed-services-consultancy_en.pdf"},
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    {"id":"33333","name":"Superseded public statement on Centella asiatica (L.) Urban, herba","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2022-09-02T01:00:00Z","last_updated_date":"2022-09-02T01:00:00Z","reference_number":"EMA/HMPC/579663/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/superseded-public-statement-centella-asiatica-l-urban-herba_en.pdf"},
    {"id":"33335","name":"What's new in pharmacovigilance - QPPV Update - Issue 2","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2016-08-09T12:35:00Z","last_updated_date":"2016-08-09T12:35:00Z","reference_number":"Issue 2","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-2_en.pdf"},
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    {"id":"33338","name":"Guideline on live recombinant vector vaccines for veterinary use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-12-01T01:00:00Z","last_updated_date":"2004-12-01T01:00:00Z","reference_number":"EMEA/CVMP/004/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-live-recombinant-vector-vaccines-veterinary-use_en.pdf"},
    {"id":"33342","name":"EU/3/16/1820: Public summary of opinion on orphan designation: Hydroxychloroquine for treatment of antiphospholipid syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/4539/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161820-public-summary-opinion-orphan-designation-hydroxychloroquine-treatment-antiphospholipid-syndrome_en.pdf"},
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    {"id":"33346","name":"Aluminium salicylate basic (Extension to oral use in cattle): Summary Report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-06-01T02:00:00Z","last_updated_date":"2002-06-01T02:00:00Z","reference_number":"EMEA/MRL/796/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/aluminium-salicylate-basic-extension-oral-use-cattle-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33348","name":"Annex A1 - Summary of EMA technical comments on the technical requirements with respect to the candidate host Member States’ offers to relocate EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T20:15:00Z","last_updated_date":"2017-10-03T20:15:00Z","reference_number":"EMA/570623/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annex-a1-summary-ema-technical-comments-technical-requirements-respect-candidate-host-member-states-offers-relocate-ema_en.pdf"},
    {"id":"33349","name":"CHMP summary of positive opinion for Telmisartan Teva Pharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/CHMP/522766/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-telmisartan-teva-pharma_en.pdf"},
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    {"id":"33354","name":"Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated viral vector serotype 8 containing the human low-density lipoprotein receptor (LDLR) gene","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:41:00Z","last_updated_date":"2018-01-03T14:41:00Z","reference_number":"EMA/751492/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adeno-associated-viral-vector-serotype-8-containing-human-low-density-lipoprotein-receptor-ldlr-gene_en.pdf"},
    {"id":"33357","name":"EU/3/14/1348: Public summary of opinion on orphan designation: Recombinant human bone morphogenetic protein 4 for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/553420/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141348-public-summary-opinion-orphan-designation-recombinant-human-bone-morphogenetic-protein-4-treatment-glioma_en.pdf"},
    {"id":"33359","name":"Quinapril: List of nationally authorised medicinal products - PSUSA/00002591/201604","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-12T10:05:00Z","last_updated_date":"2016-12-12T10:09:00Z","reference_number":"EMA/848711/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/quinapril-list-nationally-authorised-medicinal-products-psusa00002591201604_en.pdf"},
    {"id":"33360","name":"Annual list of contractors 2017 - contract values: €15,000 - €134,999","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-06-28T18:30:00Z","last_updated_date":"2018-06-28T18:30:00Z","reference_number":"EMA/404660/2018","document_url":"https://www.ema.europa.eu/en/documents/other/annual-list-contractors-2017-contract-values-eu15000-eu134999_en.pdf"},
    {"id":"33369","name":"Closing speech - Sylvie Benefice, EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T00:09:00Z","last_updated_date":"2008-11-05T00:09:00Z","reference_number":"EMEA/616285/2008","document_url":"https://www.ema.europa.eu/en/documents/other/closing-speech-sylvie-benefice-ema_en.pdf"},
    {"id":"33370","name":"Sales of veterinary antimicrobial agents in 26 European Union / European Economic Area countries in 2012: Fourth European Surveillance of Veterinary Antimicrobial Consumption report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-10-15T15:50:00Z","last_updated_date":"2014-10-15T15:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/sales-veterinary-antimicrobial-agents-26-european-union-european-economic-area-countries-2012-fourth-european-surveillance-veterinary-antimicrobial-consumption-report_en.pdf"},
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    {"id":"33372","name":"EU/3/16/1825: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype 9 containing the human N-alpha-acetylglucosaminidase gene for the treatment of mucopolysaccharidosis type ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/15565/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161825-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-9-containing-human-n-alpha-acetylglucosaminidase-gene-treatment-mucopolysaccharidosis-type_en.pdf"},
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    {"id":"33379","name":"European Medicines Agency recommends approval of first treatment for pseudobulbar affect","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/177063/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-first-treatment-pseudobulbar-affect_en.pdf"},
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    {"id":"33382","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 30 June - 1 July 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-14T13:05:00Z","last_updated_date":"2014-07-14T13:05:00Z","reference_number":"EMA/HMPC/415092/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-30-june-1-july-2014_en.pdf"},
    {"id":"33383","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Olipudase alfa for treatment of Niemann-Pick disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T17:30:00Z","last_updated_date":"2015-05-19T17:30:00Z","reference_number":"EMA/216670/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-olipudase-alfa-treatment-niemann-pick-disease_en.pdf"},
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    {"id":"33386","name":"Preparation for written procedure on adoption of the Agency’s policy on protecting the dignity of the person and preventing any form of psychological or sexual harassment","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-08T02:00:00Z","last_updated_date":"2010-10-08T02:00:00Z","reference_number":"EMA/MB/575364/2010","document_url":"https://www.ema.europa.eu/en/documents/other/preparation-written-procedure-adoption-agencys-policy-protecting-dignity-person-and-preventing-any-form-psychological-or-sexual-harassment_en.pdf"},
    {"id":"33390","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-07-13T15:40:00Z","last_updated_date":"2018-07-13T15:40:00Z","reference_number":"EMA/381105/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-adipose-cells_en.pdf"},
    {"id":"33392","name":"Work plan for the Pharmacogenomics Working Party (PGWP) 2009","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-09-25T02:09:21Z","last_updated_date":"2008-09-25T02:09:21Z","reference_number":"EMEA/324640/2008","document_url":"https://www.ema.europa.eu/en/documents/other/work-plan-pharmacogenomics-working-party-pgwp-2009_en.pdf"},
    {"id":"33393","name":"Combined hormonal contraceptives Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/combined-hormonal-contraceptives-article-31-referral-annex-iii_no.pdf"}},
    {"id":"33394","name":"Presentation - New EudraVigilance functionalities and the 2010 pharmacovigilance legislation – preparing for change: training module PhV-M1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2016-10-10T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-eudravigilance-functionalities-and-2010-pharmacovigilance-legislation-preparing-change-training-module-phv-m1_en.pdf"},
    {"id":"33395","name":"EU/3/03/143: Public summary of positive opinion for orphan designation\n\nof 5-10-methylene-tetrahydrofolate for the treatment of pancreatic cancer in combination with 5-fluorouracil","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/1098/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303143-public-summary-positive-opinion-orphan-designation-5-10-methylene-tetrahydrofolate-treatment-pancreatic-cancer-combination-5-fluorouracil_en.pdf"},
    {"id":"33396","name":"CHMP summary of positive opinion for Tuxella","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T14:00:00Z","last_updated_date":"2017-05-19T14:00:00Z","reference_number":"EMA/CHMP/307683/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tuxella_en.pdf"},
    {"id":"33400","name":"European Medicines Agency receives first pandemic influenza vaccine application","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-01-06T01:00:00Z","last_updated_date":"2006-01-06T01:00:00Z","reference_number":"EMEA/425916/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-receives-first-pandemic-influenza-vaccine-application_en.pdf"},
    {"id":"33401","name":"Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 8th annual report (2017)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-03-16T13:35:00Z","last_updated_date":"2018-03-16T13:35:00Z","reference_number":"EMA/795802/2017","document_url":"https://www.ema.europa.eu/en/documents/report/minor-use-or-minor-species-mumslimited-market-scheme-veterinary-medicinal-products-8th-annual-report-2017_en.pdf"},
    {"id":"33402","name":"Valproic acid / sodium valproate / valproate pivoxil / valproate semisodium / valpromide/valproate bismuth / calcium valproate / valproate magnesium: CMDh Scientific conclusions and grounds for variation, amendments to t...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-03T13:00:00Z","last_updated_date":"2016-10-17T20:16:36Z","reference_number":"EMA/727148/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/valproic-acid-sodium-valproate-valproate-pivoxil-valproate-semisodium-valpromidevalproate-bismuth-calcium-valproate-valproate-magnesium-cmdh-scientific-conclusions-and-grounds-variation-amendments-t_en.pdf"},
    {"id":"33404","name":"Consultation procedure - Public consultation regarding the request to the European Medicines Agency from the European Commission for scientific advice on the impact on public health and animal health of the use of antibi...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T16:15:00Z","last_updated_date":"2014-05-06T19:00:00Z","reference_number":"EMA/776691/2013 Rev1","document_url":"https://www.ema.europa.eu/en/documents/other/consultation-procedure-public-consultation-regarding-request-european-medicines-agency-european-commission-scientific-advice-impact-public-health-and-animal-health-use-antibi_en.pdf"},
    {"id":"33406","name":"Committee for Proprietary Medicinal Products (CPMP) 52nd plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-09-27T02:00:00Z","last_updated_date":"1999-09-27T02:00:00Z","reference_number":"CPMP/2590/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-52nd-plenary-meeting_en.pdf"},
    {"id":"33407","name":"Initial notices for parallel distribution - 2009","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-09-26T13:19:00Z","last_updated_date":"2011-09-26T13:19:00Z","reference_number":"EMA/742248/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2009_en.pdf"},
    {"id":"33412","name":"Guideline on clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-10-13T02:00:00Z","last_updated_date":"2005-10-13T02:00:00Z","reference_number":"EMEA/CHMP/021/97 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-hormone-replacement-therapy-oestrogen-deficiency-symptoms-postmenopausal-women-revision-1_en.pdf"},
    {"id":"33416","name":"Okrido Article-29 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-03T01:00:00Z","last_updated_date":"2014-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/okrido-article-29-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/okrido-article-29-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/okrido-article-29-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/okrido-article-29-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/okrido-article-29-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/okrido-article-29-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/okrido-article-29-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/okrido-article-29-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/okrido-article-29-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/okrido-article-29-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/okrido-article-29-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/okrido-article-29-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/okrido-article-29-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/okrido-article-29-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/okrido-article-29-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/okrido-article-29-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/okrido-article-29-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/okrido-article-29-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/okrido-article-29-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/okrido-article-29-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/okrido-article-29-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/okrido-article-29-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/okrido-article-29-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/okrido-article-29-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/okrido-article-29-referral-annex-iii_no.pdf"}},
    {"id":"33421","name":"Presentation - Public hearings (Nathalie Bere, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-hearings-nathalie-bere-ema_en.pdf"},
    {"id":"33422","name":"CAT monthly report of application procedures, guidelines\n\nand related documents on advanced therapies: April 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-04-30T16:30:00Z","last_updated_date":"2014-04-30T16:30:00Z","reference_number":"EMA/CAT/244887/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2014-meeting_en.pdf"},
    {"id":"33424","name":"Committee for Advanced Therapies (CAT): May 2009 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"EMEA/CAT/312239/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-may-2009-meeting-monthly-report_en.pdf"},
    {"id":"33425","name":"Competence requirements and training needs for quality assessors","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-06T01:00:00Z","last_updated_date":"2012-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/competence-requirements-and-training-needs-quality-assessors_en.pdf"},
    {"id":"33427","name":"Presentation - Indications and labelling - Specific aspects cross reference within the SmPC (M. Ermisch, GKV-Spitzenverband)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-indications-and-labelling-specific-aspects-cross-reference-within-smpc-m-ermisch-gkv-spitzenverband_en.pdf"},
    {"id":"33432","name":"Nifedipine: List of nationally authorised medicinal products - PSUSA/00002156/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-07T02:00:00Z","last_updated_date":"2016-10-18T12:37:33Z","reference_number":"EMA/394142/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/nifedipine-list-nationally-authorised-medicinal-products-psusa00002156201508_en.pdf"},
    {"id":"33434","name":"Presentation - European Medicines Agency re-organisation: Supporting the work of the committees (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-re-organisation-supporting-work-committees-isabelle-moulon_en.pdf"},
    {"id":"33435","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Mandatory therapeutic fields in the centralised procedure, and scientific/public health challenges for the future - HIV and Vaccines - Luc Montagnier","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-mandatory-therapeutic-fields-centralised-procedure-and-scientificpublic-health-challenges-future-hiv-and-vaccines-luc-montagnier_en.pdf"},
    {"id":"33437","name":"EU/3/11/891: Public summary of opinion on orphan designation: Human anthrax monoclonal antibody for post-exposure prophylaxis of inhalation anthrax disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2016-08-11T02:00:00Z","reference_number":"EMA/COMP/144916/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311891-public-summary-opinion-orphan-designation-human-anthrax-monoclonal-antibody-post-exposure-prophylaxis-inhalation-anthrax-disease_en.pdf"},
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    {"id":"33538","name":"Final report on the pilot joint EMEA/FDA VXDS experience on qualification of nephrotoxicity biomarkers","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2008-07-03T02:09:21Z","reference_number":"EMEA/250885/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/report/final-report-pilot-joint-emeafda-vxds-experience-qualification-nephrotoxicity-biomarkers_en.pdf"},
    {"id":"33540","name":"List of participants - Eighth stakeholders forum on the implementation of the new pharmacovigilance legislation: Building on two years of operation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"EMA/533762/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-eighth-stakeholders-forum-implementation-new-pharmacovigilance-legislation-building-two-years-operation_en.pdf"},
    {"id":"33541","name":"Presentation - Isotretinoin : Review of the pregnancy prevention programme","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T01:00:00Z","last_updated_date":"2011-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-isotretinoin-review-pregnancy-prevention-programme_en.pdf"},
    {"id":"33543","name":"Meningococcal group c polysaccharide conjugate vaccine: List of nationally authorised medicinal products - PSUSA/00001971/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-10-18T11:29:34Z","reference_number":"EMA/423930/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/meningococcal-group-c-polysaccharide-conjugate-vaccine-list-nationally-authorised-medicinal-products-psusa00001971201510_en.pdf"},
    {"id":"33544","name":"PDCO meeting report 8-10 December 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/PDCO/790151/2010 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-8-10-december-2010_en.pdf"},
    {"id":"33545","name":"Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/CHMP/EWP/176348/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-diabetes-mellitus-revision-1_en.pdf"},
    {"id":"33546","name":"Guidelines and concept papers adopted during the CHMP meeting 16-19 September 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-26T17:35:00Z","last_updated_date":"2013-09-26T17:35:00Z","reference_number":"EMA/568760/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-16-19-september-2013_en.pdf"},
    {"id":"33547","name":"CHMP summary of positive opinion for Eviplera","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/736674/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eviplera_en.pdf"},
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    {"id":"33549","name":"CHMP post-authorisation summary of positive opinion for Stribild","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/CHMP/603432/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stribild_en.pdf"},
    {"id":"33551","name":"Superseded overview of comments received on 'Betula pendula Roth; Betula pubescens Ehrh., folium' (EMEA/HMPC/260019/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2007-05-08T02:09:21Z","last_updated_date":"2015-03-13T01:09:21Z","reference_number":"EMEA/HMPC/488559/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-betula-pendula-roth-betula-pubescens-ehrh-folium-emeahmpc2600192006_en.pdf"},
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    {"id":"33564","name":"Draft list of references supporting the assessment of Glycine max (L.) Merr., oleum","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-07-25T02:00:00Z","last_updated_date":"2016-07-25T02:00:00Z","reference_number":"EMA/HMPC/338916/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-glycine-max-l-merr-oleum_en.pdf"},
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    {"id":"33590","name":"Loraxin - Article-29(4) referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-02-28T01:00:00Z","last_updated_date":"2013-02-28T01:00:00Z","reference_number":"EMA/29457/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/loraxin-article-294-referral-assessment-report_en.pdf"},
    {"id":"33591","name":"CVMP post-authorisation summary of positive opinion for Melovem","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-19T18:00:00Z","last_updated_date":"2013-07-19T18:00:00Z","reference_number":"EMA/CVMP/384390/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-melovem_en.pdf-0"},
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    {"id":"33595","name":"Dihydroergocristine: List of nationally authorised medicinal products - PSUSA/00001071/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2016-10-17T19:52:25Z","reference_number":"EMA/865167/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/dihydroergocristine-list-nationally-authorised-medicinal-products-psusa00001071201504_en.pdf"},
    {"id":"33596","name":"CHMP post-authorisation summary of positive opinion for Viread","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T13:00:00Z","last_updated_date":"2013-03-22T13:00:00Z","reference_number":"EMA/CHMP/161713/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-viread_en.pdf-0"},
    {"id":"33598","name":"EU/3/18/1973: Public summary of opinion on orphan designation: 2'-O-(2-methoxyethyl)-modified antisense oligonucleotide targeting exon 13 in the USH2A gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-10T02:00:00Z","last_updated_date":"2018-04-10T02:00:00Z","reference_number":"EMA/56907/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181973-public-summary-opinion-orphan-designation-2-o-2-methoxyethyl-modified-antisense-oligonucleotide-targeting-exon-13-ush2a-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"33601","name":"Presentation - Orphan medicinal products in the European centralised procedure: current marketing authorisations for Gaucher disease (Andrea Taft)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-28T01:00:00Z","last_updated_date":"2012-11-28T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orphan-medicinal-products-european-centralised-procedure-current-marketing-authorisations-gaucher-disease-andrea-taft_en.pdf"},
    {"id":"33602","name":"Letter of support for Predictive Safety Testing Consortium translational drug-induced kidney injury biomarkers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-07T16:56:00Z","last_updated_date":"2014-11-07T16:56:00Z","reference_number":"EMA/651243/2014","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-predictive-safety-testing-consortium-translational-drug-induced-kidney-injury-biomarkers_en.pdf"},
    {"id":"33606","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph  on Valeriana officinalis L., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2006-07-13T02:09:21Z","last_updated_date":"2016-04-27T02:09:21Z","reference_number":"EMEA/HMPC/313368/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"33609","name":"Questions and answers on the refusal of the marketing authorisation for Lodipressin (amlodipine besilate)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"EMA/55773/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-lodipressin-amlodipine-besilate_sv.pdf"}},
    {"id":"33611","name":"News bulletin for small and medium-sized enterprises - Issue 18","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T16:50:00Z","last_updated_date":"2011-12-21T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-18_en.pdf"},
    {"id":"33612","name":"Presentation - Exploring changes in treatment effects across design stages in adaptive trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-exploring-changes-treatment-effects-across-design-stages-adaptive-trials_en.pdf"},
    {"id":"33613","name":"Paracetamol Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-08-09T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-annex-i_en.pdf-0"},
    {"id":"33614","name":"Final list of references supporting the assessment of Ribes nigrum L., folium - revision 1","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T10:03:00Z","last_updated_date":"2017-12-19T10:03:00Z","reference_number":"EMA/HMPC/745349/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-ribes-nigrum-l-folium-revision-1_en.pdf"},
    {"id":"33615","name":"Presentation - Neuromyelitis optica testimonial - Speech (Irene Wilson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-neuromyelitis-optica-testimonial-speech-irene-wilson_en.pdf"},
    {"id":"33618","name":"The EMEA and the CMD(h) review Europe-wide experience with user consultation in the readability testing of package leaflets","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-11-15T01:00:00Z","last_updated_date":"2006-11-15T01:00:00Z","reference_number":"EMEA/457658/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-and-cmdh-review-europe-wide-experience-user-consultation-readability-testing-package-leaflets_en.pdf"},
    {"id":"33619","name":"EU/3/15/1564: Public summary of opinion on orphan designation: Dronabinol and cannabidiol for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-18T11:00:00Z","last_updated_date":"2015-11-18T11:00:00Z","reference_number":"EMA/COMP/607076/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151564-public-summary-opinion-orphan-designation-dronabinol-and-cannabidiol-treatment-glioma_en.pdf"},
    {"id":"33620","name":"Presentation - Subgroup analyses – scene setting from the EU regulators perspective (Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subgroup-analyses-scene-setting-eu-regulators-perspective-hemmings_en.pdf"},
    {"id":"33621","name":"Sandimmun Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T17:00:00Z","last_updated_date":"2013-12-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sandimmun-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sandimmun-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sandimmun-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sandimmun-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sandimmun-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sandimmun-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sandimmun-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sandimmun-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sandimmun-article-30-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sandimmun-article-30-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sandimmun-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sandimmun-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sandimmun-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sandimmun-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sandimmun-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sandimmun-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sandimmun-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sandimmun-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sandimmun-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sandimmun-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sandimmun-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sandimmun-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sandimmun-article-30-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/sandimmun-article-30-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/sandimmun-article-30-referral-annex-i_no.pdf"}},
    {"id":"33622","name":"Final list of references supporting the assessment of Verbascum thapsus L., V. densiflorum Bertol. (V. thapsiforme Schrad), and V. phlomoides L., flos","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T02:00:00Z","last_updated_date":"2018-06-22T02:00:00Z","reference_number":"EMA/HMPC/611532/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-verbascum-thapsus-l-v-densiflorum-bertol-v-thapsiforme-schrad-and-v-phlomoides-l-flos_en.pdf"},
    {"id":"33623","name":"Alfaprostol (Extension to rabbits): Summary Report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-04T01:00:00Z","last_updated_date":"2015-05-01T02:00:00Z","reference_number":"EMEA/MRL/440/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/alfaprostol-extension-rabbits-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33624","name":"CHMP summary of positive opinion for Nevirapine Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2023-03-21T02:00:00Z","reference_number":"EMEA/CHMP/578510/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nevirapine-teva_en.pdf"},
    {"id":"33625","name":"Clenil Article-30 referral - Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-11-18T01:00:00Z","reference_number":"EMA/612121/2016 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    {"id":"33780","name":"Agenda - Workshop on nanomedicines: 2-3 September 2010","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-03-15T01:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"EMA/273690/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-nanomedicines-2-3-september-2010_en.pdf"},
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    {"id":"33786","name":"Superseded community herbal monograph on Plantago ovata Forssk., semen","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2006-10-26T02:00:00Z","last_updated_date":"2013-07-23T02:00:00Z","reference_number":"EMEA/HMPC/340861/2005","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-plantago-ovata-forssk-semen_en.pdf"},
    {"id":"33787","name":"Presentation - EU IDMP/SPOR Task Force meeting: Project proposal: IMI FaCE facts (5. agenda) (David Lewis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-idmpspor-task-force-meeting-project-proposal-imi-face-facts-5-agenda-david-lewis_en.pdf"},
    {"id":"33789","name":"Questions and answers on the referral for Octegra solution for infusion containing moxifloxacin 400 mg/250 ml","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:08:21Z","last_updated_date":"2009-06-25T02:08:21Z","reference_number":"EMEA/CHMP/150525/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-octegra-solution-infusion-containing-moxifloxacin-400-mg250-ml_sv.pdf"}},
    {"id":"33790","name":"Hydroxyzine Article-31 referral - PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-05-08T19:00:00Z","last_updated_date":"2014-05-13T17:20:00Z","reference_number":"EMA/PRAC/261900/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"33792","name":"Presentation - How Paediatric Research Networks can help drug development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T17:10:00Z","last_updated_date":"2017-01-04T17:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-paediatric-research-networks-can-help-drug-development_en.pdf"},
    {"id":"33793","name":"European Medicines Agency publishes initial list of medicines under additional monitoring","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-04-25T12:00:00Z","last_updated_date":"2013-04-25T12:00:00Z","reference_number":"EMA/251554/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-publishes-initial-list-medicines-under-additional-monitoring_en.pdf"},
    {"id":"33794","name":"Piperazine: Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-11-01T01:00:00Z","last_updated_date":"2001-11-01T01:00:00Z","reference_number":"EMEA/MRL/807/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/piperazine-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33795","name":"Gasiloxe: List of nationally authorised medicinal products - PSUSA/00010283/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-13T02:00:00Z","last_updated_date":"2016-10-18T16:56:41Z","reference_number":"EMA/677351/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/gasiloxe-list-nationally-authorised-medicinal-products-psusa00010283201501_en.pdf"},
    {"id":"33796","name":"Online strategy and interface design EMA/2012/37/ED – Technical specification annex III - Response questionnaire","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-07T02:00:00Z","last_updated_date":"2013-07-05T17:15:00Z","reference_number":"EMA/117115/2013","document_url":"https://www.ema.europa.eu/en/documents/other/online-strategy-and-interface-design-ema201237ed-technical-specification-annex-iii-response-questionnaire_en.xls"},
    {"id":"33798","name":"Medicinal products (non-steroidal anti-inflammatory compounds) for the treatment of chronic disorders","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-02-01T01:00:00Z","last_updated_date":"2015-02-01T01:00:00Z","reference_number":"3CC17a","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/medicinal-products-non-steroidal-anti-inflammatory-compounds-treatment-chronic-disorders_en.pdf"},
    {"id":"33802","name":"Presentation - Best expertise vs conflicts of interests: Striking the right balance - Academia (human medicines) (Ludwig Wolf-Dieter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-best-expertise-vs-conflicts-interests-striking-right-balance-academia-human-medicines-ludwig-wolf-dieter_en.pdf"},
    {"id":"33804","name":"Presentation - Non-clinical Assessment Requirements - Perspectives from a Member State","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-clinical-assessment-requirements-perspectives-member-state_en.pdf"},
    {"id":"33805","name":"Guideline on the choice of the non-inferiority margin","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"EMEA/CPMP/EWP/2158/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-choice-non-inferiority-margin_en.pdf"},
    {"id":"33807","name":"Inductos Article-20 procedure -  Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/inductos-article-20-procedure-notification_en.pdf"},
    {"id":"33808","name":"Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-01-09T18:00:00Z","last_updated_date":"2015-01-09T18:00:00Z","reference_number":"EMEA/CHMP/BMWP/42832/2005 Rev1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues-revision-1_en.pdf"},
    {"id":"33810","name":"Tetrazepam-containing medicines - Article-107i procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T13:00:00Z","last_updated_date":"2013-01-11T13:00:00Z","reference_number":"EMA/PRAC/15074/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-timetable-procedure_en.pdf"},
    {"id":"33811","name":"Superseded list of references supporting the assessment report on: Anisi fructus and Anisi aetheroleum Pimpinella anisum L., fructus and Pimpinella anisum L., aetheroleum (aniseed and anise oil)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-06-12T02:09:21Z","last_updated_date":"2014-06-18T02:09:21Z","reference_number":"EMEA/HMPC/359388/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-anisi-fructus-and-anisi-aetheroleum-pimpinella-anisum-l-fructus-and-pimpinella-anisum-l-aetheroleum-aniseed-and-anise-oil_en.pdf"},
    {"id":"33812","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Lisbon","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-lisbon_en.pdf"},
    {"id":"33813","name":"Agenda for the Extraordinary meeting of the Management Board on 1 October 2015","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-09-29T16:00:00Z","last_updated_date":"2015-10-01T16:00:00Z","reference_number":"EMA/MB/392855/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-extraordinary-meeting-management-board-1-october-2015_en.pdf"},
    {"id":"33816","name":"Summary of procedures for consultation by the Committee for Medicinal Products for Veterinary Use of scientific advisory groups (SAGs) and ad-hoc expert groups functioning as SAGs in relation to applications for authoris...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-04-07T02:00:00Z","last_updated_date":"2011-04-07T02:00:00Z","reference_number":"EMA/347137/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/summary-procedures-consultation-committee-medicinal-products-veterinary-use-scientific-advisory-groups-sags-and-ad-hoc-expert-groups-functioning-sags-relation-applications-authoris_en.pdf"},
    {"id":"33817","name":"EU/3/03/167: Public summary of positive opinion for orphan designation of H-Tyrosine-Glycine-Phenylalanine-Glycine-Glycine-OH for the treatment of chronic idiopathic myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2009-09-21T02:00:00Z","reference_number":"EMEA/COMP/1579/2003 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303167-public-summary-positive-opinion-orphan-designation-h-tyrosine-glycine-phenylalanine-glycine-glycine-oh-treatment-chronic-idiopathic-myelofibrosis_en.pdf"},
    {"id":"33820","name":"Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/201508","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-21T02:00:00Z","last_updated_date":"2016-10-17T17:46:45Z","reference_number":"EMA/284169/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00010298201508_en.pdf"},
    {"id":"33825","name":"Presentation - EU reference network - Directive 2011-24-EU (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-reference-network-directive-2011-24-eu-irmgard-eichler_en.pdf"},
    {"id":"33826","name":"Pimecrolimus: List of nationally authorised medicinal products - PSUSA/00002411/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T15:00:00Z","last_updated_date":"2016-10-28T15:00:00Z","reference_number":"EMA/676059/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/pimecrolimus-list-nationally-authorised-medicinal-products-psusa00002411201603_en.pdf"},
    {"id":"33829","name":"Questions and answers - Overview of comments received on ‘Draft questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-03-23T12:50:00Z","last_updated_date":"2017-03-23T12:50:00Z","reference_number":"EMA/71927/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/questions-and-answers-overview-comments-received-draft-questions-and-answers-ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnological-biological-entities_en.pdf"},
    {"id":"33830","name":"VICH Topic GL36: Safety of veterinary drugs in human food: General approach to establish a microbiological ADI - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-04-30T02:00:00Z","last_updated_date":"2007-04-30T02:00:00Z","reference_number":"CVMP/VICH/467/03-FINAL-corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-topic-gl36-safety-veterinary-drugs-human-food-general-approach-establish-microbiological-adi-step-7_en.pdf"},
    {"id":"33831","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-09-30T11:30:00Z","last_updated_date":"2014-09-30T11:30:00Z","reference_number":"EMA/CAT/581538/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-september-2014-meeting_en.pdf"},
    {"id":"33832","name":"Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/396864/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/adempas-not-use-patients-pulmonary-hypertension-caused-idiopathic-interstitial-pneumonia_en.pdf"},
    {"id":"33833","name":"Committee for medicinal products for human use, summary of positive opinion for Relistor","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/198599/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-relistor_en.pdf"},
    {"id":"33834","name":"Final assessment report on Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-05-18T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMA/HMPC/3206/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"33835","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cytomegalovirus-specific cytotoxic T lymphocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:45:00Z","last_updated_date":"2017-02-28T14:45:00Z","reference_number":"EMA/126953/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-cytomegalovirus-specific-cytotoxic-t-lymphocytes_en.pdf"},
    {"id":"33836","name":"Norfloxacin - Article 31 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-08-29T02:08:21Z","last_updated_date":"2006-08-29T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/norfloxacin-article-31-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"33837","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous cell concentrate from bone marrow aspirate","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-11-08T10:45:00Z","last_updated_date":"2013-11-08T10:45:00Z","reference_number":"EMA/661080/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cell-concentrate-bone-marrow-aspirate_en.pdf"},
    {"id":"33839","name":"Final community herbal monograph on Viola tricolor L.","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/HMPC/131734/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-viola-tricolor-l_en.pdf"},
    {"id":"33840","name":"EU/3/10/833: Public summary of opinion on orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes) for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/COMP/754491/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310833-public-summary-opinion-orphan-designation-doxorubicin-hydrochloride-heat-sensitive-liposomes-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"33841","name":"Atropine: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-10-01T02:00:00Z","last_updated_date":"1998-10-01T02:00:00Z","reference_number":"EMEA/MRL/517/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/atropine-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33844","name":"EU/3/10/731: Public summary of opinion on orphan designation: Bafetinib for the treatment of chronic myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2013-07-31T02:00:00Z","reference_number":"EMA/COMP/90894/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310731-public-summary-opinion-orphan-designation-bafetinib-treatment-chronic-myeloid-leukaemia_en.pdf"},
    {"id":"33845","name":"GlaxoSmithKline Biologicals withdraws its application for a scientific opinion for Globorix","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-10-16T02:09:21Z","last_updated_date":"2007-10-16T02:09:21Z","reference_number":"EMEA/475583/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/glaxosmithkline-biologicals-withdraws-its-application-scientific-opinion-globorix_en.pdf"},
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    {"id":"33851","name":"Overview of comments received on draft guideline on Core SmPC for human plasma fibrinogen products (EMEA/CHMP/BPWP/122007/2005)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-02-19T01:00:00Z","last_updated_date":"2007-02-19T01:00:00Z","reference_number":"EMEA/CHMP/BPWP/399089/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-core-smpc-human-plasma-fibrinogen-products-emeachmpbpwp1220072005_en.pdf"},
    {"id":"33852","name":"European Medicines Agency’s Scientific Coordination Board starts reflection on best cooperation between scientific committees","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-04-25T18:40:00Z","last_updated_date":"2012-04-25T18:40:00Z","reference_number":"EMA/274306/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-scientific-coordination-board-starts-reflection-best-cooperation-between-scientific-committees_en.pdf"},
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    {"id":"33855","name":"Questions and answers on the withdrawal of the marketing authorisation application for Duloxetine Sandoz (duloxetine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/249807/2015","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-duloxetine-sandoz-duloxetine_sv.pdf"}},
    {"id":"33856","name":"Ad hoc working party on Herbal Medicinal Products:  Final comments for revision of the notice to applicants volume 2B Part IC1 'Tabular formats specific to Herbal Medicinal Products'","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-01-28T01:00:00Z","last_updated_date":"1999-01-28T01:00:00Z","reference_number":"EMEA/HMPWP/16/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-party-herbal-medicinal-products-final-comments-revision-notice-applicants-volume-2b-part-ic1-tabular-formats-specific-herbal-medicinal-products_en.pdf"},
    {"id":"33857","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 November 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-11-19T01:00:00Z","last_updated_date":"2010-11-19T01:00:00Z","reference_number":"EMA/CHMP/734452/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-november-2010_en.pdf"},
    {"id":"33859","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human umbilical cord blood-derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T16:30:00Z","last_updated_date":"2017-10-23T16:30:00Z","reference_number":"EMA/534881/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-umbilical-cord-blood-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"33863","name":"Supserseded list of references supporting the assessment report on Menthae piperitae aetheroleum Mentha x piperita L., aetheroleum (peppermint oil)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/199469/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/supserseded-list-references-supporting-assessment-report-menthae-piperitae-aetheroleum-mentha-x-piperita-l-aetheroleum-peppermint-oil_en.pdf"},
    {"id":"33864","name":"CHMP summary of positive opinion for Insulin lispro Sanofi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T02:00:00Z","last_updated_date":"2017-05-19T02:00:00Z","reference_number":"EMA/CHMP/269671/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-insulin-lispro-sanofi_en.pdf"},
    {"id":"33866","name":"Public summary report - Inhibitor development in previously untreated patients with severe haemophilia A treated with recombinant factor VIII products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-13T17:00:00Z","last_updated_date":"2016-05-13T17:00:00Z","reference_number":"EMA/PRAC/332348/2016","document_url":"https://www.ema.europa.eu/en/documents/report/public-summary-report-inhibitor-development-previously-untreated-patients-severe-haemophilia-treated-recombinant-factor-viii-products_en.pdf"},
    {"id":"33868","name":"Revised procedure for the appointment of the Executive Director - Extraordinary Management Board meeting 5 May 2011","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-06-16T02:00:00Z","last_updated_date":"2011-06-16T02:00:00Z","reference_number":"EMA/MB/400828/2009","document_url":"https://www.ema.europa.eu/en/documents/other/revised-procedure-appointment-executive-director-extraordinary-management-board-meeting-5-may-2011_en.pdf"},
    {"id":"33871","name":"CHMP post-authorisation summary of positive opinion for Zonegran","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/CHMP/416989/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zonegran_en.pdf-0"},
    {"id":"33874","name":"Superseded overview of comments received on 'Community herbal monograph on Pimpinella anisum L., fructus' (EMEA/HMPC/137423/2006)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-06-12T02:09:21Z","last_updated_date":"2014-06-17T02:09:21Z","reference_number":"EMEA/HMPC/286755/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-pimpinella-anisum-l-fructus-emeahmpc1374232006_en.pdf"},
    {"id":"33876","name":"Dexlansoprazole, lansoprazole: List of nationally authorised medicinal products - PSUSA/00001827/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-06T17:30:00Z","last_updated_date":"2017-11-06T17:53:44Z","reference_number":"EMA/727763/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexlansoprazole-lansoprazole-list-nationally-authorised-medicinal-products-psusa00001827201612_en.pdf"},
    {"id":"33877","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-07-19T18:30:00Z","last_updated_date":"2013-07-19T18:30:00Z","reference_number":"EMA/CVMP/405417/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-july-2013_en.pdf"},
    {"id":"33879","name":"Reviparin: List of nationally authorised medicinal products - PSUSA/00002634/201501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T12:00:00Z","last_updated_date":"2016-10-17T19:46:18Z","reference_number":"EMA/622828/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/reviparin-list-nationally-authorised-medicinal-products-psusa00002634201501_en.pdf"},
    {"id":"33880","name":"Tylosin (extension to eggs): Summary Report (4) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T00:09:21Z","last_updated_date":"2000-03-01T00:09:21Z","reference_number":"EMEA/MRL/732/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tylosin-extension-eggs-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33885","name":"Reflection paper criteria for requiring one additional five-year renewal for centrally authorised medicinal products","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-15T01:00:00Z","last_updated_date":"2007-11-15T01:00:00Z","reference_number":"EMEA/131973/2006","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-criteria-requiring-one-additional-five-year-renewal-centrally-authorised-medicinal-products_en.pdf"},
    {"id":"33886","name":"Day 80 assessment report non-clinical and clinical guidance - generics rev.10.16","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-07-08T15:20:00Z","last_updated_date":"2016-11-08T12:00:00Z","reference_number":"Rev. 10.16","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-non-clinical-and-clinical-guidance-generics-rev1016_en.pdf"},
    {"id":"33888","name":"European Medicines Agency’s Management Board elects new chair and vice-chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-08T02:09:21Z","last_updated_date":"2007-06-08T02:09:21Z","reference_number":"EMEA/252232/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-elects-new-chair-and-vice-chair_en.pdf"},
    {"id":"33889","name":"Public statement on concerns over unregulated medicinal products containing stem cells","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2010-04-16T02:00:00Z","last_updated_date":"2010-04-17T02:00:00Z","reference_number":"EMA/763463/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-concerns-over-unregulated-medicinal-products-containing-stem-cells_en.pdf"},
    {"id":"33894","name":"Dinoprostone: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2007-06-01T02:00:00Z","last_updated_date":"2007-06-01T02:00:00Z","reference_number":"EMEA/CVMP/235871/2007","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dinoprostone-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33896","name":"Presentation - FDA, EuPFI, WHO Collaborations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-eupfi-who-collaborations_en.pdf"},
    {"id":"33897","name":"Inductos Article-20 procedure - CHMP list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/CHMP/492625/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/inductos-article-20-procedure-chmp-list-questions_en.pdf"},
    {"id":"33899","name":"Presentation - Medicines shortages in Europe: A picture of the problem from the hospital-pharmacy perspective (Roberto Frontini)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T17:00:00Z","last_updated_date":"2013-07-18T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-shortages-europe-picture-problem-hospital-pharmacy-perspective-roberto-frontini_en.pdf"},
    {"id":"33900","name":"Closantel: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-15T02:00:00Z","last_updated_date":"1996-05-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/closantel-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33902","name":"EU/3/11/943: Public summary of positive opinion for orphan designation: Mogamulizumab for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-02-01T15:00:00Z","last_updated_date":"2012-05-04T14:00:00Z","reference_number":"EMA/COMP/938736/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311943-public-summary-positive-opinion-orphan-designation-mogamulizumab-treatment-peripheral-t-cell-lymphoma-nodal-other-extranodal-and-leukaemicdisseminated_en.pdf"},
    {"id":"33905","name":"Sixth annual report on the interaction with patients' and consumers' organisations (2012)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-12-17T11:30:00Z","last_updated_date":"2013-12-17T11:30:00Z","reference_number":"EMA/272219/2013","document_url":"https://www.ema.europa.eu/en/documents/report/sixth-annual-report-interaction-patients-and-consumers-organisations-2012_en.pdf"},
    {"id":"33906","name":"Orphan drug and paediatric clinical trials - EMEA workshop on metholigical aspects of clinical trials for efficacy evaluation in small populations","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-11-12T00:09:21Z","last_updated_date":"2002-11-12T00:09:21Z","reference_number":"EMEA/28972/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/orphan-drug-and-paediatric-clinical-trials-emea-workshop-metholigical-aspects-clinical-trials-efficacy-evaluation-small-populations_en.pdf"},
    {"id":"33907","name":"Presentation - Clinical trials in CF - regulatory perspective: endpoints for added clinical benefit in view of HTA (Paolo D. Siviero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-cf-regulatory-perspective-endpoints-added-clinical-benefit-view-hta-paolo-d-siviero_en.pdf"},
    {"id":"33908","name":"CHMP summary of positive opinion for Hirobriz Breezhaler","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/592257/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hirobriz-breezhaler_en.pdf"},
    {"id":"33909","name":"Agenda - CAT agenda of the 8-9 September 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-09-09T19:00:00Z","last_updated_date":"2016-09-09T19:00:00Z","reference_number":"EMA/CAT/605735/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-8-9-september-2016-meeting_en.pdf"},
    {"id":"33911","name":"Human medicines highlights - March 2014","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-04-04T17:20:00Z","last_updated_date":"2014-04-04T17:20:00Z","reference_number":"Issue 61","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-march-2014_en.pdf"},
    {"id":"33912","name":"European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-03-26T01:00:00Z","last_updated_date":"2013-03-26T01:00:00Z","reference_number":"EMA/178662/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-investigates-findings-pancreatic-risks-glp-1-based-therapies-type-2-diabetes_en.pdf"},
    {"id":"33913","name":"Linear alkyl benzene sulphonic acids (Extension to sheep): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-07-01T02:00:00Z","last_updated_date":"2004-07-01T02:00:00Z","reference_number":"EMEA/MRL/908/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/linear-alkyl-benzene-sulphonic-acids-extension-sheep-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"33915","name":"EU/3/16/1664: Public summary of opinion on orphan designation: Polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase for treatment of homocystinuria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"EMA/COMP/309791/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161664-public-summary-opinion-orphan-designation-polyethylene-glycol-modified-human-recombinant-truncated-cystathionine-beta-synthase-treatment-homocystinuria_en.pdf"},
    {"id":"33917","name":"Ethinylestradiol-Drospirenone 24+4 Article-6(12) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ethinylestradiol-drospirenone-244-article-612-referral-annex-ii_sv.pdf"}},
    {"id":"33918","name":"Draft guideline on follow-up of patients administered with gene therapy Medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/60436/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-follow-patients-administered-gene-therapy-medicinal-products_en.pdf"},
    {"id":"33922","name":"Presentation - Committee for Advanced Therapies (CAT) feedback: Chimeric antigen receptor (CAR) T cell therapies - EMA's PCWP and HCPWP joint meeting (Kieran Breen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-committee-advanced-therapies-cat-feedback-chimeric-antigen-receptor-car-t-cell-therapies-emas-pcwp-and-hcpwp-joint-meeting-kieran-breen_en.pdf"},
    {"id":"33923","name":"Nimesulide - Article 31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-04-19T02:00:00Z","last_updated_date":"2012-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nimesulide-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nimesulide-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nimesulide-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nimesulide-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nimesulide-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nimesulide-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nimesulide-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nimesulide-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nimesulide-article-31-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nimesulide-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nimesulide-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nimesulide-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nimesulide-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nimesulide-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nimesulide-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nimesulide-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nimesulide-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nimesulide-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nimesulide-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nimesulide-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nimesulide-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nimesulide-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"33924","name":"Committee for Medicinal Products for Human Use elects new chair and vice-chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-19T02:00:00Z","last_updated_date":"2007-06-19T02:00:00Z","reference_number":"EMEA/271971/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-human-use-elects-new-chair-and-vice-chair_en.pdf"},
    {"id":"33927","name":"EU/3/16/1768: Public summary of positive opinion for orphan designation of xenon for the treatment of ischaemia reperfusion injury associated with cardiac arrest","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/622430/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161768-public-summary-positive-opinion-orphan-designation-xenon-treatment-ischaemia-reperfusion-injury-associated-cardiac-arrest_en.pdf"},
    {"id":"33929","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 24-26 February 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-02-27T00:09:21Z","last_updated_date":"2004-02-27T00:09:21Z","reference_number":"EMEA/CPMP/857/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-24-26-february-2004_en.pdf"},
    {"id":"33930","name":"PDCO monthly report of opinions on paediatric investigation plans: 8-10 February 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-02-16T15:00:00Z","last_updated_date":"2012-02-16T15:00:00Z","reference_number":"EMA/PDCO/95918/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-8-10-february-2012_en.pdf"},
    {"id":"33931","name":"Questions and answers on the withdrawal of the marketing application\n\nfor Ellefore","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-11-12T01:00:00Z","last_updated_date":"2008-11-12T01:00:00Z","reference_number":"EMEA/544525/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ellefore_sv.pdf"}},
    {"id":"33933","name":"CHMP summary of positive opinion for Xerava","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"EMA/CHMP/447907/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xerava_en.pdf"},
    {"id":"33934","name":"EU/3/15/1505: Public summary of opinion on orphan designation: Obinutuzumab for the treatment of marginal zone lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2016-10-20T02:00:00Z","reference_number":"EMA/COMP/350571/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151505-public-summary-opinion-orphan-designation-obinutuzumab-treatment-marginal-zone-lymphoma_en.pdf"},
    {"id":"33935","name":"ADHOC working group meeting on herbal medicinal products 18 and 19 January","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-01-18T01:00:00Z","last_updated_date":"1999-01-18T01:00:00Z","reference_number":"EMEA/HMPWG/5/99 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/adhoc-working-group-meeting-herbal-medicinal-products-18-and-19-january_en.pdf"},
    {"id":"33938","name":"Guideline on the use of bovine serum in the manufacture of human biological medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-06-04T11:10:00Z","last_updated_date":"2013-06-04T11:10:00Z","reference_number":"EMA/CHMP/BWP/457920/2012 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-bovine-serum-manufacture-human-biological-medicinal-products-revision-1_en.pdf"},
    {"id":"33939","name":"EU/3/17/1864: Public summary of opinion on orphan designation: Emeramide for the prevention of mercury toxicity","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/208446/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171864-public-summary-opinion-orphan-designation-emeramide-prevention-mercury-toxicity_en.pdf"},
    {"id":"33941","name":"Draft guideline on similar medicinal products containing recombinant interferon alpha","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-10-18T02:00:00Z","last_updated_date":"2007-10-18T02:00:00Z","reference_number":"EMEA/CHMP/BMWP/102046/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-medicinal-products-containing-recombinant-interferon-alpha_en.pdf"},
    {"id":"33943","name":"Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-04-14T02:00:00Z","last_updated_date":"2010-05-07T02:00:00Z","reference_number":"EMEA/CHMP/BMWP/301636/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-erythropoietins-revision_en.pdf"},
    {"id":"33945","name":"PDCO meetings in 2023, 2024, 2025 and 2026","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-03-13T10:13:00Z","last_updated_date":"2023-03-13T10:13:00Z","reference_number":"EMA/109170/2023","document_url":"https://www.ema.europa.eu/en/documents/other/pdco-meetings-2023-2024-2025-and-2026_en.pdf"},
    {"id":"33946","name":"Scientific recommendation on classification of advanced therapy medicinal products: human hepatoblastoma cells (HepG2) encapsulated in alginate, expanded to competence and maintained in a fluidised bed bioreactor","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T15:30:00Z","last_updated_date":"2016-04-19T15:30:00Z","reference_number":"EMA/265343/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-hepatoblastoma-cells-hepg2-encapsulated-alginate-expanded-competence-and-maintained-fluidised-bed-bioreactor_en.pdf"},
    {"id":"33947","name":"VICH GL30 on pharmacovigilance of veterinary medicinal products: controlled list of terms","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-07-20T02:00:00Z","last_updated_date":"2013-12-16T19:00:00Z","reference_number":"EMA/CVMP/VICH/647/2001","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl30-pharmacovigilance-veterinary-medicinal-products-controlled-list-terms_en.pdf"},
    {"id":"33950","name":"Presentation - Shortages of medicinal products due to manufacturing and quality problems: Update from working groups (Andrea Taft)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-shortages-medicinal-products-due-manufacturing-and-quality-problems-update-working-groups-andrea-taft_en.pdf"},
    {"id":"33952","name":"Antimicrobial resistance - Combating a serious threat to public and animal health","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-11-18T12:30:00Z","last_updated_date":"2015-11-18T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/antimicrobial-resistance-combating-serious-threat-public-and-animal-health_en.pdf"},
    {"id":"33953","name":"European Medicines Agency recommends first marketing authorisation for an advanced therapy medicinal product","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-26T02:09:21Z","last_updated_date":"2009-06-26T02:09:21Z","reference_number":"EMEA/CHMP/394741/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-first-marketing-authorisation-advanced-therapy-medicinal-product_en.pdf"},
    {"id":"33955","name":"Intravenous iron-containing medicinal products Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-01T02:00:00Z","last_updated_date":"2013-10-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/intravenous-iron-containing-medicinal-products-article-31-referral-annex-iv_sv.pdf"}},
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    {"id":"34053","name":"Guidelines on statistical principles for veterinary clinical trials","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-11-09T01:00:00Z","last_updated_date":"2000-11-09T01:00:00Z","reference_number":"EMEA/CVMP/816/00/Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-statistical-principles-veterinary-clinical-trials_en.pdf"},
    {"id":"34055","name":"Keppra: Product Information as approved by the CHMP on 13 October 2016, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/keppra-product-information-approved-chmp-13-october-2016-pending-endorsement-european-commission_en.pdf"},
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    {"id":"34057","name":"EU/3/13/1217: Public summary of opinion on orphan designation: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabi...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-22T01:00:00Z","last_updated_date":"2022-06-14T01:00:00Z","reference_number":"EMA/COMP/700146/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131217-public-summary-opinion-orphan-designation-4r5r-1-4-4-33-dibutyl-7-dimethylamino-2345-tetrahydro-4-hydroxy-11-dioxido-1-benzothiepin-5-ylphenoxymethylphenylmethyl-4-aza-1-azoniabi_en.pdf"},
    {"id":"34063","name":"EU/3/14/1419: Public summary of opinion on orphan designation: Tenofovir disoproxil fumarate for the treatment of Aicardi-Goutià¨res syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/COMP/797338/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141419-public-summary-opinion-orphan-designation-tenofovir-disoproxil-fumarate-treatment-aicardi-goutiares-syndrome_en.pdf"},
    {"id":"34068","name":"Myderison - Article 29 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-06-16T02:00:00Z","last_updated_date":"2011-06-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/myderison-article-29-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/myderison-article-29-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/myderison-article-29-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/myderison-article-29-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/myderison-article-29-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/myderison-article-29-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/myderison-article-29-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/myderison-article-29-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/myderison-article-29-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/myderison-article-29-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/myderison-article-29-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/myderison-article-29-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/myderison-article-29-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/myderison-article-29-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/myderison-article-29-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/myderison-article-29-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/myderison-article-29-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/myderison-article-29-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/myderison-article-29-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/myderison-article-29-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/myderison-article-29-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/myderison-article-29-referral-annex-i_sv.pdf"}},
    {"id":"34069","name":"Successes of the Paediatric Regulation after five years","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-06T11:19:00Z","last_updated_date":"2013-06-06T11:19:00Z","reference_number":"EMA/250577/2013","document_url":"https://www.ema.europa.eu/en/documents/other/successes-paediatric-regulation-after-five-years_en.pdf"},
    {"id":"34070","name":"Participants list - IPA introductory meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-ipa-introductory-meeting_en.pdf"},
    {"id":"34071","name":"Agenda and registration form - The new EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course (Lisbon)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-05-19T12:57:00Z","last_updated_date":"2017-06-15T16:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-lisbon_en.pdf-0"},
    {"id":"34072","name":"EU/3/15/1524: Public summary of opinion on orphan designation: Triheptanoin for the treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T02:00:00Z","last_updated_date":"2015-08-18T02:00:00Z","reference_number":"EMA/COMP/432825/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151524-public-summary-opinion-orphan-designation-triheptanoin-treatment-long-chain-3-hydroxyacyl-coa-dehydrogenase-deficiency_en.pdf"},
    {"id":"34073","name":"Superseded opinion of the HMPC on a Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"EMA/HMPC/332110/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"34074","name":"EU/3/04/252: Public summary of positive opinion for orphan designation of Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for the treatment of chronic myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-06T00:00:00Z","last_updated_date":"2009-11-19T00:00:00Z","reference_number":"EMEA/COMP/152652/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304252-public-summary-positive-opinion-orphan-designation-val-leu-gln-glu-leu-asn-val-thr-val-pr1-nanopeptide-sequence-169-177-proteinase-3-treatment-chronic-myeloid-leukaemia_en.pdf"},
    {"id":"34075","name":"CHMP summary of positive opinion for Ulunar Breezhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/65875/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ulunar-breezhaler_en.pdf"},
    {"id":"34077","name":"Agenda for the 66th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/MB/3790/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-66th-meeting-management-board_en.pdf"},
    {"id":"34078","name":"Presentation - Current clinical evidence for the therapeutic use of bacteriophages (Xavier Wittebole)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-22T02:00:00Z","last_updated_date":"2015-06-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-clinical-evidence-therapeutic-use-bacteriophages-xavier-wittebole_en.pdf"},
    {"id":"34079","name":"Presentation - Immunologicals – industry perspective (Ariane van de Moer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunologicals-industry-perspective-ariane-van-de-moer_en.pdf"},
    {"id":"34083","name":"Dactylis glomarata (8%), Lolium perenne (8%), Phleum pratense (8%), Poa pratensis (8%), Anthoxhantum odoratum (8%), Secale cereale (10%), Betula pendula (16,7%), Corylus avellana (16,6%) and Alnus glutinosa (16,6%) - Not...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/dactylis-glomarata-8-lolium-perenne-8-phleum-pratense-8-poa-pratensis-8-anthoxhantum-odoratum-8-secale-cereale-10-betula-pendula-167-corylus-avellana-166-and-alnus-glutinosa-166-not_en.pdf"},
    {"id":"34084","name":"Procedural advice on the submission of variations for annual update of human-influenza-inactivated-vaccine applications in the centralised procedure - Revision 2 - Superseded","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T11:10:00Z","last_updated_date":"2013-04-30T11:10:00Z","reference_number":"EMA/CHMP/BWP/99698/2007 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/procedural-advice-submission-variations-annual-update-human-influenza-inactivated-vaccine-applications-centralised-procedure-revision-2-superseded_en.pdf"},
    {"id":"34085","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Solidago virgaurea L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/305296/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-solidago-virgaurea-l-herba_en.pdf"},
    {"id":"34087","name":"Technical specifications for open invitation to tender no. EMEA/2006/35/ACC, banking services for European Medicines Agency (EMEA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-08-29T02:00:00Z","last_updated_date":"2006-08-29T02:00:00Z","reference_number":"EMEA/3419/04/5736","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-open-invitation-tender-no-emea200635acc-banking-services-european-medicines-agency-emea_en.pdf"},
    {"id":"34088","name":"CHMP summary of positive opinion for Cablivi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"EMA/CHMP/419463/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cablivi_en.pdf"},
    {"id":"34089","name":"EU/3/16/1658: Public summary of opinion on orphan designation: 4-[(2E)-1-oxo-3-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-propen-1-yl]-1-piperazinecarboxamide for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2017-08-16T02:00:00Z","reference_number":"EMA/COMP/314054/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161658-public-summary-opinion-orphan-designation-4-2e-1-oxo-3-266-trimethyl-1-cyclohexen-1-yl-2-propen-1-yl-1-piperazinecarboxamide-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"34090","name":"Benefit-risk methodology project","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2011-07-26T02:00:00Z","last_updated_date":"2011-07-26T02:00:00Z","reference_number":"EMEA/108979/2009","document_url":"https://www.ema.europa.eu/en/documents/report/benefit-risk-methodology-project_en.pdf"},
    {"id":"34091","name":"EMEA announces new Head of Unit for Communications and Networking","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-05-02T02:00:00Z","last_updated_date":"2002-05-02T02:00:00Z","reference_number":"EMEA/D/10545/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-announces-new-head-unit-communications-and-networking_en.pdf"},
    {"id":"34099","name":"Presentation - Good pharmacovigilance practices module XV (Jane Ahlqvist Rastad, Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-module-xv-jane-ahlqvist-rastad-juan-garcia-burgos_en.pdf"},
    {"id":"34101","name":"List of participants - Workshop on draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-workshop-draft-reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf"},
    {"id":"34103","name":"Committee for medicinal products for veterinary use: Meeting of 10 to 12 October 2006","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T14:09:21Z","last_updated_date":"2006-10-12T14:09:21Z","reference_number":"EMEA/CVMP/391009/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-10-12-october-2006_en.pdf"},
    {"id":"34105","name":"Presentation - Non-clinical development of gene-therapy medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-clinical-development-gene-therapy-medicinal-products_en.pdf"},
    {"id":"34107","name":"CVMP post-authorisation summary of opinion for Broadline (II/0013)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-05-15T02:00:00Z","last_updated_date":"2017-05-15T02:00:00Z","reference_number":"EMA/CVMP/259214/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-opinion-broadline-ii0013_en.pdf"},
    {"id":"34108","name":"Questions and answers on the recommendation for the refusal of the marketing authorisation for Zeftera","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-02-19T01:00:00Z","last_updated_date":"2010-02-19T01:00:00Z","reference_number":"EMA/83783/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-zeftera_en.pdf"},
    {"id":"34110","name":"Presentation - Health-technology-assessment-body (HTA) view (Leeza Osipenko)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T01:00:00Z","last_updated_date":"2013-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-health-technology-assessment-body-hta-view-leeza-osipenko_en.pdf"},
    {"id":"34111","name":"Questions and answers on the review of monovalent and multivalent measles, mumps, rubella and / or varicella vaccines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T13:00:00Z","last_updated_date":"2014-03-12T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines_sv.pdf"}},
    {"id":"34112","name":"Press release - It’s time to reduce, replace and re-think the use of antimicrobials in animals","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-01-24T11:00:00Z","last_updated_date":"2017-01-24T11:00:00Z","reference_number":"EMA/CVMP/47873/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-its-time-reduce-replace-and-re-think-use-antimicrobials-animals_en.pdf"},
    {"id":"34113","name":"Dorzolamide / timolol: List of nationally authorised medicinal products - PSUSA/00001166/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-14T15:31:00Z","last_updated_date":"2016-11-15T11:56:56Z","reference_number":"EMA/739666/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/dorzolamide-timolol-list-nationally-authorised-medicinal-products-psusa00001166201602_en.pdf"},
    {"id":"34114","name":"Committee for medicinal products for human use, summary of positive opinion for Ribavirin Teva Pharma BV","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2021-07-09T02:00:00Z","reference_number":"EMEA/CHMP/228100/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-ribavirin-teva-pharma-bv_en.pdf"},
    {"id":"34115","name":"Metamizole: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2003-06-01T02:00:00Z","last_updated_date":"2003-06-01T02:00:00Z","reference_number":"EMEA/MRL/878/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/metamizole-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34116","name":"List of participants - Healthcare Professionals Working Group (HCPWG) meeting 27 Feb 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/50873/2013","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-healthcare-professionals-working-group-hcpwg-meeting-27-feb-2013_en.pdf"},
    {"id":"34118","name":"Presentation - Data for executing the consortium’s research plan: applying regulatory science to neonatal electronic data (Neena Modi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-executing-consortiums-research-plan-applying-regulatory-science-neonatal-electronic-data-neena-modi_en.pdf"},
    {"id":"34120","name":"Mandate, objectives and rules of procedure for the CVMP Scientific Advice Working Party (SAWP-V)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2007-09-18T02:09:21Z","last_updated_date":"2018-06-04T14:00:00Z","reference_number":"EMA/CVMP/SAWP/676117/2010 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-cvmp-scientific-advice-working-party-sawp-v_en.pdf"},
    {"id":"34121","name":"Opinion following an Article-33 referral for Avinew","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-05T02:00:00Z","last_updated_date":"2014-08-05T02:00:00Z","reference_number":"EMA/310365/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-avinew_en.pdf"},
    {"id":"34122","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n13-16 November 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-11-17T00:09:21Z","last_updated_date":"2006-11-17T00:09:21Z","reference_number":"EMEA/460883/2006 - corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-13-16-november-2006_en.pdf"},
    {"id":"34123","name":"CHMP ORGAM agenda for the meeting on 13 February 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-02-15T13:35:00Z","last_updated_date":"2017-02-15T13:35:00Z","reference_number":"EMA/CHMP/105294/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-13-february-2017_en.pdf"},
    {"id":"34125","name":"Milnacipran: CMDh scientific conclusions and grounds for the variation,\n\namendments to the product information, and timetable\n\nfor the implementation - PSUSA/00002063/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T01:00:00Z","last_updated_date":"2016-10-18T12:21:25Z","reference_number":"EMA/172346/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/milnacipran-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002063201504_en.pdf"},
    {"id":"34127","name":"Biomarker validation - Why, which and how? - Charles T. Benson","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/biomarker-validation-why-which-and-how-charles-t-benson_en.pdf"},
    {"id":"34130","name":"Presentation - The Pharmacovigilance Risk Assessment Committee","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T22:06:09Z","last_updated_date":"2011-06-24T22:06:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-risk-assessment-committee_en.pdf"},
    {"id":"34131","name":"On consultation on changes in the membership of the CHMP and CVMP scientific committees","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/MB/715154/2009","document_url":"https://www.ema.europa.eu/en/documents/other/consultation-changes-membership-chmp-and-cvmp-scientific-committees_en.pdf"},
    {"id":"34133","name":"The use of ionising radiation in the manufacture of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1991-12-01T01:00:00Z","last_updated_date":"1991-12-01T01:00:00Z","reference_number":"3AQ4A","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/use-ionising-radiation-manufacture-medicinal-products_en.pdf"},
    {"id":"34134","name":"Overview of comments received on 'Core SmPC and package leaflet for technetium (99mTc) sestamibi","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T15:15:00Z","last_updated_date":"2013-12-17T15:15:00Z","reference_number":"EMA/528960/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-core-smpc-and-package-leaflet-technetium-99mtc-sestamibi_en.pdf"},
    {"id":"34135","name":"Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-02-01T13:00:00Z","last_updated_date":"2018-02-01T13:00:00Z","reference_number":"EMA/CHMP/356878/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/rilpivirine-film-coated-tablets-25-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"34139","name":"Presentation - The Accelerated Development of Vaccine benefit-risk Collaboration in Europe (ADVANCE) project on vaccines (Jose Drabwell)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accelerated-development-vaccine-benefit-risk-collaboration-europe-advance-project-vaccines-jose-drabwell_en.pdf"},
    {"id":"34140","name":"Vedaprofen: Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-10-01T02:00:00Z","last_updated_date":"1996-10-01T02:00:00Z","reference_number":"EMEA/MRL/144/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/vedaprofen-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34141","name":"CHMP summary of positive opinion for Levetiracetam Sun","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-10-21T02:00:00Z","last_updated_date":"2011-10-21T02:00:00Z","reference_number":"EMA/CHMP/752234/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-levetiracetam-sun_en.pdf"},
    {"id":"34143","name":"Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-23T11:11:00Z","last_updated_date":"2018-07-23T11:11:00Z","reference_number":"EMEA/CHMP/BMWP/301636/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-erythropoietins-revision-1_en.pdf"},
    {"id":"34144","name":"Presentation - Breakout session - Neonatal sepsis (Danny Benjamin and Catherine Sherwin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-neonatal-sepsis-danny-benjamin-and-catherine-sherwin_en.pdf"},
    {"id":"34145","name":"European Medicines Agency Modelling and Simulation Working Group plan 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-02T14:30:00Z","last_updated_date":"2014-06-02T14:30:00Z","reference_number":"EMA/303847/2014","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-modelling-and-simulation-working-group-plan-2014_en.pdf"},
    {"id":"34146","name":"Questions and answers on recommendation for the refusal of the marketing authorisation  for  Natalizumab Elan Pharma","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-11-15T00:09:21Z","last_updated_date":"2007-11-15T00:09:21Z","reference_number":"EMEA/530964/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-authorisation-natalizumab-elan-pharma_en.pdf"},
    {"id":"34147","name":"Pre-notification check for type IA/IAIN variations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-18T14:57:33Z","last_updated_date":"2017-06-30T16:00:00Z","reference_number":"EMA/746161/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/pre-notification-check-type-iaiain-variations_en.pdf"},
    {"id":"34151","name":"Committee on herbal medicinal products (HMPC): Meeting report, 11-12 January 2006","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-02-02T01:00:00Z","last_updated_date":"2006-02-02T01:00:00Z","reference_number":"EMEA/HMPC/21014/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-11-12-january-2006_en.pdf"},
    {"id":"34153","name":"Zinbryta Article-20 procedure - Multiple sclerosis medicine Zinbryta suspended in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T01:00:00Z","last_updated_date":"2018-03-14T01:00:00Z","reference_number":"EMA/134289/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinbryta-article-20-procedure-multiple-sclerosis-medicine-zinbryta-suspended-eu_sv.pdf"}},
    {"id":"34154","name":"ICH guideline Q4B annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical sieving - general chapter - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2013-02-11T12:00:00Z","reference_number":"EMA/CHMP/ICH/730808/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-12-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-analytical-sieving-general-chapter-step-5_en.pdf"},
    {"id":"34155","name":"Presentation - Haemophilia registries quantity versus quality: the current situation in Europe (Christine Keipert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-haemophilia-registries-quantity-versus-quality-current-situation-europe-christine-keipert_en.pdf"},
    {"id":"34156","name":"Luprostiol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-04-01T02:00:00Z","last_updated_date":"1997-04-01T02:00:00Z","reference_number":"EMEA/MRL/200/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/luprostiol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34158","name":"Guidelines and concept papers adopted during the CHMP meeting 12-15 November 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-22T10:15:00Z","last_updated_date":"2012-11-22T10:15:00Z","reference_number":"EMA/CHMP/732276/2012","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-12-15-november-2012_en.pdf"},
    {"id":"34159","name":"Results of juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in children","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-11-30T12:47:00Z","last_updated_date":"2017-11-30T12:47:00Z","reference_number":"EMA/629174/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/results-juvenile-animal-studies-jas-and-impact-anti-cancer-medicine-development-and-use-children_en.pdf"},
    {"id":"34164","name":"Final list of references supporting the assessment of Lavandula angustifolia Miller, aetheroleum and Lavandula angustifolia Miller, flos","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-06-13T18:00:00Z","last_updated_date":"2012-06-13T18:00:00Z","reference_number":"EMA/HMPC/143182/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-lavandula-angustifolia-miller-aetheroleum-and-lavandula-angustifolia-miller-flos_en.pdf"},
    {"id":"34167","name":"Presentation - Cardiology Network (Sylvie DI FILIPPO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cardiology-network-sylvie-di-filippo_en.pdf-0"},
    {"id":"34168","name":"Minoxidil (non topical formulation): List of nationally authorised medicinal products - PSUSA/0002066/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-12T02:00:00Z","last_updated_date":"2016-10-18T12:21:23Z","reference_number":"EMA/483360/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/minoxidil-non-topical-formulation-list-nationally-authorised-medicinal-products-psusa0002066201510_en.pdf"},
    {"id":"34169","name":"Tilmicosin: Summary Report (1) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tilmicosin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34170","name":"CHMP post-authorisation positive summary of opinion for Teysuno","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-12-16T12:50:00Z","last_updated_date":"2011-12-16T12:50:00Z","reference_number":"EMA/796457/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-positive-summary-opinion-teysuno_en.pdf"},
    {"id":"34171","name":"Apomorphine: List of nationally authorised medicinal products - PSUSA/00000227/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-07-12T17:29:00Z","last_updated_date":"2017-07-12T17:31:36Z","reference_number":"EMA/442514/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/apomorphine-list-nationally-authorised-medicinal-products-psusa00000227201611_en.pdf"},
    {"id":"34174","name":"Overview of comments for the guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-12-02T00:09:21Z","last_updated_date":"2009-12-02T00:09:21Z","reference_number":"EMEA/CHMP/EWP/582423/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-guideline-clinical-investigations-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"34175","name":"Presentation - Review of requirements for immunological medicinal products and their evolution since the start of Community legislation on medicines (Carmen Jungback)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-review-requirements-immunological-medicinal-products-and-their-evolution-start-community-legislation-medicines-carmen-jungback_en.pdf"},
    {"id":"34176","name":"Start of community reviews adopted during the CHMP meeting of 16-19 January 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-01-20T13:00:00Z","last_updated_date":"2012-01-20T13:00:00Z","reference_number":"EMA/43544/2012","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-adopted-during-chmp-meeting-16-19-january-2012_en.pdf"},
    {"id":"34180","name":"Draft community herbal monograph on Ruscus aculeatus L, rhizome - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-09-07T02:00:00Z","last_updated_date":"2007-09-07T02:00:00Z","reference_number":"EMEA/HMPC/261938/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-ruscus-aculeatus-l-rhizome-first-version_en.pdf"},
    {"id":"34181","name":"Guideline on good pharmacovigilance practices (GVP) product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-12-12T16:00:00Z","last_updated_date":"2013-12-12T16:00:00Z","reference_number":"EMA/488220/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-or-population-specific-considerations-i-vaccines-prophylaxis-against-infectious-diseases-tracked-changes_en.pdf"},
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    {"id":"34183","name":"Presentation - Breakout session 2: Science and data","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-27T17:35:00Z","last_updated_date":"2013-11-27T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-2-science-and-data_en.pdf"},
    {"id":"34189","name":"Hydroxyethyl starch Article-107i procedure - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-06T01:00:00Z","last_updated_date":"2014-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-cmdh-divergent-position_en.pdf"},
    {"id":"34190","name":"EU/3/12/1054: Public summary of opinion on orphan designation: Obinutuzumab for the treatment of chronic lymphocytic leukaemia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/COMP/612787/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121054-public-summary-opinion-orphan-designation-obinutuzumab-treatment-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"34191","name":"Committee for medicinal products for veterinary use: Meeting of 16 - 18 January 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-01-19T12:19:21Z","last_updated_date":"2007-01-19T12:19:21Z","reference_number":"EMEA/CVMP/1660/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-16-18-january-2007_en.pdf"},
    {"id":"34193","name":"Gadolinium Article-31 referral – Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T01:00:00Z","last_updated_date":"2016-03-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-notification_en.pdf"},
    {"id":"34195","name":"Letter from Thomas Là¶nngren 10-02-2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-03-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-thomas-lapnngren-10-02-2011_en.pdf"},
    {"id":"34196","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2013 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-10-24T17:40:00Z","last_updated_date":"2013-10-24T17:40:00Z","reference_number":"EMA/CAT/574533/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-october-2013-meeting_en.pdf"},
    {"id":"34198","name":"Questions and answers on the marketing authorisation for Ceplene","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:09:21Z","last_updated_date":"2008-07-24T02:09:21Z","reference_number":"EMEA/398628/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-marketing-authorisation-ceplene_en.pdf"},
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    {"id":"34201","name":"Request for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004' to be replaced by 'Briefing Note and Recommendations on a Request for Accelerated Assessment Pursuant to Article 14 (9) of Regulation (EC) No 726/2004 - Template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2011-11-03T16:35:00Z","last_updated_date":"2021-02-17T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-accelerated-assessment-pursuant-article-149-regulation-ec-no-7262004-be-replaced-briefing-note-and-recommendations-request-accelerated-assessment-pursuant-article-14-9-regulation-ec-no-7262004_en.docx"},
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    {"id":"34206","name":"Methylprednisolone Article-35 referral - Annexes I, II, III, IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T12:00:00Z","last_updated_date":"2017-08-04T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methylprednisolone-article-35-referral-annexes-i-ii-iii-iv_sv.pdf"}},
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    {"id":"34211","name":"Response to public comments received on the ‘Inventory of paediatric therapeutic needs – Respiratory’","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T14:08:00Z","last_updated_date":"2016-10-07T14:08:00Z","reference_number":"EMA/528945/2016","document_url":"https://www.ema.europa.eu/en/documents/other/response-public-comments-received-inventory-paediatric-therapeutic-needs-respiratory_en.pdf"},
    {"id":"34212","name":"Vandetanib film-coated tablets 100 mg and 300 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-03T01:00:00Z","last_updated_date":"2017-03-03T01:00:00Z","reference_number":"EMA/CHMP/474883/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vandetanib-film-coated-tablets-100-mg-and-300-mg-product-specific-bioequivalence-guidance_en.pdf"},
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    {"id":"34216","name":"Committee for Orphan Medicinal Products: December 2003 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-12-08T01:00:00Z","last_updated_date":"2003-12-08T01:00:00Z","reference_number":"EMEA/COMP/1603/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-december-2003-meeting_en.pdf"},
    {"id":"34220","name":"CHMP post-authorisation summary of positive opinion for Sifrol on 25 June 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"EMEA/CHMP/391474/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sifrol-25-june-2009_en.pdf"},
    {"id":"34222","name":"EU/3/07/441: Public summary of positive opinion for orphan designation of hydrocortisone (modified release tablet) for the treatment of adrenal insufficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2020-10-20T16:00:00Z","reference_number":"EMEA/COMP/57720/2007 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307441-public-summary-positive-opinion-orphan-designation-hydrocortisone-modified-release-tablet-treatment-adrenal-insufficiency_en.pdf"},
    {"id":"34224","name":"Oxytocin: List of nationally authorised medicinal products - PSUSA/00002263/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T13:55:00Z","last_updated_date":"2018-04-27T14:18:16Z","reference_number":"EMA/266096/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxytocin-list-nationally-authorised-medicinal-products-psusa00002263201706_en.pdf"},
    {"id":"34225","name":"Presentation - Frailty: Challenges and possible solutions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-frailty-challenges-and-possible-solutions_en.pdf"},
    {"id":"34226","name":"Opinion following an article 33 referral for Porcimectin solution for injection and its associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2014-08-13T02:00:00Z","reference_number":"EMA/249005/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-porcimectin-solution-injection-and-its-associated-names_en.pdf"},
    {"id":"34228","name":"Challenges with Advanced Therapy Medicinal Products - Christian K Schneider","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/challenges-advanced-therapy-medicinal-products-christian-k-schneider_en.pdf"},
    {"id":"34229","name":"Ibuprofen and dexibuprofen Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-14T02:00:00Z","last_updated_date":"2015-07-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"34230","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - Annex I-III - Xigduo","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-05-08T14:00:00Z","last_updated_date":"2017-05-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-i-iii-xigduo_no.pdf"}},
    {"id":"34234","name":"Opinion following an Article 36 referral for Bupropion hydrochloride International Non-Proprietary Name (INN): Bupropion: Background information and Annexes I, II (English) and Annex III (All languages)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-11-29T00:08:21Z","last_updated_date":"2002-11-29T00:08:21Z","reference_number":"CPMP/27610/02","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-36-referral-bupropion-hydrochloride-international-non-proprietary-name-inn-bupropion-background-information-and-annexes-i-ii-english-and-annex-iii-all-languages_sv.pdf"}},
    {"id":"34235","name":"EMA advice on use of colistin in animals to be updated","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"EMA/CVMP/832098/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-advice-use-colistin-animals-be-updated_en.pdf"},
    {"id":"34236","name":"Presentation - Patient organisations' considerations (David Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-07T01:00:00Z","last_updated_date":"2012-12-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-organisations-considerations-david-haerry_en.pdf"},
    {"id":"34238","name":"European Medicine Agency: Committee for Medicinal Products for Human Use, 27-29 July 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-07-29T02:00:00Z","last_updated_date":"2004-07-29T02:00:00Z","reference_number":"EMEA/21550/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicine-agency-committee-medicinal-products-human-use-27-29-july-2004_en.pdf"},
    {"id":"34244","name":"Results of HMA survey of collection of data on sales and use of AMs in Member States - Alfred Hera","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/results-hma-survey-collection-data-sales-and-use-ams-member-states-alfred-hera_en.pdf"},
    {"id":"34245","name":"Decision tree on escalation from national to European level","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T00:00:00Z","last_updated_date":"2013-01-29T00:00:00Z","reference_number":"EMA/314722/2013","document_url":"https://www.ema.europa.eu/en/documents/other/decision-tree-escalation-national-european-level_en.pdf"},
    {"id":"34246","name":"EU/3/15/1496: Public summary of opinion on orphan designation: Trehalose for the treatment of oculopharyngeal muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/COMP/280663/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151496-public-summary-opinion-orphan-designation-trehalose-treatment-oculopharyngeal-muscular-dystrophy_en.pdf"},
    {"id":"34247","name":"EU/3/12/1007: Public summary of opinion on orphan designation: 17-(Dimethylaminoethylamino)-17-demethoxygeldanamycin (after administration of adeno-associated viral vector encoding an inducible short hairpin RNA targetin...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-12-17T01:00:00Z","last_updated_date":"2016-08-11T02:00:00Z","reference_number":"EMA/COMP/357653/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121007-public-summary-opinion-orphan-designation-17-dimethylaminoethylamino-17-demethoxygeldanamycin-after-administration-adeno-associated-viral-vector-encoding-inducible-short-hairpin-rna-targetin_en.pdf"},
    {"id":"34248","name":"Implications of the EMEA Naming Policy - An industry perspective Anja Manz - Novartis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/implications-emea-naming-policy-industry-perspective-anja-manz-novartis_en.pdf"},
    {"id":"34250","name":"Presentation - Consumer safety issues - Approach for injection site residues (Bruno Urbain)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-consumer-safety-issues-approach-injection-site-residues-bruno-urbain_en.pdf"},
    {"id":"34251","name":"Guideline on clinical evaluation of medicinal products used in weight management - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-08T12:50:00Z","last_updated_date":"2016-07-08T12:50:00Z","reference_number":"EMA/CHMP/311805/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-medicinal-products-used-weight-management-revision-1_en.pdf"},
    {"id":"34254","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human guideline Q10 on pharmaceutical quality system - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2014-05-28T17:30:00Z","reference_number":"EMA/CHMP/ICH/214732/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-guideline-q10-pharmaceutical-quality-system-step-5_en.pdf"},
    {"id":"34256","name":"Presentation - Topic 1 - Stakeholder perspectives on the development\n\nof new methodologies BOND ERN perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Luca Sangio...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-1-stakeholder-perspectives-development-new-methodologies-bond-ern-perspective-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-luca-sangio_en.pdf"},
    {"id":"34260","name":"EU/3/06/350: Public summary of positive opinion for orphan designation of alpha-1 proteinase inhibitor for the treatment of emphysema secondary to congenital alpha-1 antitrypsin deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/17827/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306350-public-summary-positive-opinion-orphan-designation-alpha-1-proteinase-inhibitor-treatment-emphysema-secondary-congenital-alpha-1-antitrypsin-deficiency_en.pdf"},
    {"id":"34261","name":"Reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"EMA/CHMP/CVMP/3Rs/164002/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-providing-overview-current-regulatory-testing-requirements-veterinary-medicinal-products-and-opportunities-implementation-3rs_en.pdf"},
    {"id":"34263","name":"Overview of comments received on European Union herbal monograph on Hedera helix L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-01-18T01:00:00Z","last_updated_date":"2016-01-18T01:00:00Z","reference_number":"EMA/HMPC/624379/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-hedera-helix-l-folium_en.pdf"},
    {"id":"34265","name":"Presentation - The relationship between PML-rituximab and other immunobiologicals: an overview, Renaud Du Pasquier","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-relationship-between-pml-rituximab-and-other-immunobiologicals-overview-renaud-du-pasquier_en.pdf"},
    {"id":"34267","name":"EU/3/07/451: Public summary of positive opinion for orphan designation of cisplatin (liposomal) for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T00:00:00Z","last_updated_date":"2007-12-04T00:00:00Z","reference_number":"EMEA/COMP/167850/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307451-public-summary-positive-opinion-orphan-designation-cisplatin-liposomal-treatment-pancreatic-cancer_en.pdf"},
    {"id":"34268","name":"CHMP summary of positive opinion for Vipidia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T02:00:00Z","last_updated_date":"2013-07-26T02:00:00Z","reference_number":"EMA/CHMP/229786/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vipidia_en.pdf"},
    {"id":"34273","name":"COMP November 2009 plenary meeting: Monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-11-11T00:09:21Z","last_updated_date":"2009-11-18T00:00:00Z","reference_number":"EMEA/COMP/679278/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-november-2009-plenary-meeting-monthly-report_en.pdf"},
    {"id":"34274","name":"PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-02-13T13:00:00Z","last_updated_date":"2015-02-13T13:00:00Z","reference_number":"EMA/85678/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-new-measures-minimise-known-heart-risks-hydroxyzine-containing-medicines_en.pdf"},
    {"id":"34277","name":"Mifepristone Article 29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-01-03T01:00:00Z","reference_number":"EMA/556309/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/mifepristone-article-294-referral-assessment-report_en.pdf"},
    {"id":"34278","name":"Analysis and assessment of the 2008 annual activity report of the Executive Director","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-06-11T02:09:21Z","last_updated_date":"2009-06-11T02:09:21Z","reference_number":"EMEA/MB/319028/2009","document_url":"https://www.ema.europa.eu/en/documents/report/analysis-and-assessment-2008-annual-activity-report-executive-director_en.pdf"},
    {"id":"34279","name":"Quinagolide: List of nationally authorised medicinal products - PSUSA/00002590/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T11:28:00Z","last_updated_date":"2018-04-19T11:32:45Z","reference_number":"EMA/243043/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/quinagolide-list-nationally-authorised-medicinal-products-psusa00002590201707_en.pdf"},
    {"id":"34280","name":"Presentation - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting dates for 2015 (Nathalie B...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-working-party-hcpwp-meeting-dates-2015-nathalie_en.pdf"},
    {"id":"34281","name":"Start of community reviews - CHMP meeting of 14-17 December 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/817359/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-14-17-december-2015_en.pdf"},
    {"id":"34283","name":"Declaration of interests - Wolfgang Gopel","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-wolfgang-gopel_en.pdf"},
    {"id":"34284","name":"Presentation - Case study: Evaluation of health based exposure limits and potential impact on manufacturing equipment cleaning limits (G. Allison, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-evaluation-health-based-exposure-limits-and-potential-impact-manufacturing-equipment-cleaning-limits-g-allison-efpia_en.pdf"},
    {"id":"34287","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow mononuclear cells (BM-MNC)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-22T12:00:00Z","last_updated_date":"2016-03-22T12:00:00Z","reference_number":"EMA/203997/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-mononuclear-cells-bm-mnc_en.pdf"},
    {"id":"34289","name":"Quixil: Product information as approved by the CHMP on 15 November 2012, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T12:54:00Z","last_updated_date":"2012-11-23T12:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/quixil-product-information-approved-chmp-15-november-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"34290","name":"CHMP summary of positive opinion for Udenyca","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"EMA/490650/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-udenyca_en.pdf"},
    {"id":"34292","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 3-5 June 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/CVMP/307034/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-3-5-june-2014_en.pdf"},
    {"id":"34294","name":"Presentation - NK Cells (Evren Alici)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nk-cells-evren-alici_en.pdf"},
    {"id":"34295","name":"Minutes of the 72nd meeting of the Management Board: 8-9 June 2011","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2011-08-16T02:00:00Z","reference_number":"EMA/MB/465305/2011","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-72nd-meeting-management-board-8-9-june-2011_en.pdf"},
    {"id":"34296","name":"Support for applications on Article 58","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-02-07T12:30:00Z","last_updated_date":"2017-02-07T12:30:00Z","reference_number":"EMA/619778/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/support-applications-article-58_en.pdf"},
    {"id":"34300","name":"Call for expressions of interest, from software vendors, service providers and pharmacovigilance system implementers, to attend a workshop on 4 March 2016 on the implementation of international ICSR standard (ICH E2B(R3)...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-13T17:00:00Z","last_updated_date":"2016-01-13T17:00:00Z","reference_number":"EMA/847935/2015","document_url":"https://www.ema.europa.eu/en/documents/other/call-expressions-interest-software-vendors-service-providers-and-pharmacovigilance-system-implementers-attend-workshop-4-march-2016-implementation-international-icsr-standard-ich-e2br3_en.pdf"},
    {"id":"34302","name":"EMEA meeting with interested parties on the review process on names for medicinal products - Ann Robins","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-09-11T02:09:21Z","last_updated_date":"2006-09-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-meeting-interested-parties-review-process-names-medicinal-products-ann-robins_en.pdf"},
    {"id":"34303","name":"Final list of references supporting the assessment of Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-09-10T02:00:00Z","last_updated_date":"2014-09-10T02:00:00Z","reference_number":"EMA/HMPC/137300/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-rosa-gallica-l-rosa-centifolia-l-rosa-damascena-mill-flos_en.pdf"},
    {"id":"34304","name":"CHMP summary of positive opinion for Ameluz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-10-21T02:00:00Z","last_updated_date":"2011-10-21T02:00:00Z","reference_number":"EMA/CHMP/486900/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ameluz_en.pdf"},
    {"id":"34307","name":"Committee for medicinal products for human use, summary of positive opinion  for Volibris","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2008-02-21T01:00:00Z","reference_number":"EMEA/CHMP/31425/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-volibris_en.pdf"},
    {"id":"34308","name":"Ark Therapeutics withdraws its marketing authorisation application for Cerepro","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-20T02:00:00Z","last_updated_date":"2007-07-20T02:00:00Z","reference_number":"EMEA/331059/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/ark-therapeutics-withdraws-its-marketing-authorisation-application-cerepro_en.pdf"},
    {"id":"34309","name":"EU/3/15/1434: Public summary of opinion on orphan designation: Chimeric group B adenovirus (11p/3) with deletions in the E3 and E4 regions for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-08T02:00:00Z","last_updated_date":"2021-06-25T02:00:00Z","reference_number":"EMA/COMP/49562/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151434-public-summary-opinion-orphan-designation-chimeric-group-b-adenovirus-11p3-deletions-e3-and-e4-regions-treatment-ovarian-cancer_en.pdf"},
    {"id":"34311","name":"European Medicines Agency master data management roadmap","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T16:00:00Z","last_updated_date":"2015-04-29T16:00:00Z","reference_number":"EMA/730453/2014","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-master-data-management-roadmap_en.pdf"},
    {"id":"34313","name":"Questions and answers on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - First version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-09-18T14:36:00Z","last_updated_date":"2017-09-18T14:36:00Z","reference_number":"EMA/CVMP/IWP/466888/2017","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-first-version_en.pdf"},
    {"id":"34314","name":"EU/3/04/207: Public summary of positive opinion for orphan designation of sorafenib tosylate for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2016-08-10T14:30:00Z","reference_number":"EMEA/COMP/294/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304207-public-summary-positive-opinion-orphan-designation-sorafenib-tosylate-treatment-renal-cell-carcinoma_en.pdf"},
    {"id":"34315","name":"Manganese carbonate:  European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-21T01:00:00Z","last_updated_date":"2013-11-21T01:00:00Z","reference_number":"EMA/CVMP/14468/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/manganese-carbonate-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"34316","name":"Annexes to the application form for certification of quality and non-clinical data for Advanced Therapy Medicinal Products developed by Small and Medium-sized Enterprises (SME)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-02-15T01:00:00Z","last_updated_date":"2010-02-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annexes-application-form-certification-quality-and-non-clinical-data-advanced-therapy-medicinal-products-developed-small-and-medium-sized-enterprises-sme_en.doc"},
    {"id":"34317","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 25-28 April 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-05-11T17:10:00Z","last_updated_date":"2016-05-11T17:10:00Z","reference_number":"EMA/76598/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-25-28-april-2016_en.pdf"},
    {"id":"34320","name":"Agenda - Workshop: In vitro Cytokine release assays; To predict Cytokine release syndrome: The current state-of-the-science","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2009-08-12T02:09:21Z","last_updated_date":"2009-11-18T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-vitro-cytokine-release-assays-predict-cytokine-release-syndrome-current-state-science_en.pdf"},
    {"id":"34321","name":"News bulletin for small and medium-sized enterprises - Issue 26","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-01-07T17:37:00Z","last_updated_date":"2014-01-07T17:37:00Z","reference_number":"Issue 26","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-26_en.pdf"},
    {"id":"34322","name":"Veterinary medicines highlights 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T13:15:00Z","last_updated_date":"2018-02-13T13:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/veterinary-medicines-highlights-2017_en.pdf"},
    {"id":"34323","name":"EU/3/10/758: Public summary of opinion on orphan designation: Pomalidomide for the treatment of post-polycythaemia vera myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-08-06T13:32:00Z","last_updated_date":"2017-02-10T12:32:00Z","reference_number":"EMA/COMP/249456/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310758-public-summary-opinion-orphan-designation-pomalidomide-treatment-post-polycythaemia-vera-myelofibrosis_en.pdf"},
    {"id":"34325","name":"Committee for medicinal products for veterinary use: Meeting of 9 to 11 November 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-11-15T12:39:21Z","last_updated_date":"2004-11-15T12:39:21Z","reference_number":"EMEA/CVMP/1076/04-corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-9-11-november-2004_en.pdf"},
    {"id":"34327","name":"Presentation - Committee for Medicinal Products for Human Use feedback (Fà¡tima Ventura, CHMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-committee-medicinal-products-human-use-feedback-fatima-ventura-chmp_en.pdf"},
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    {"id":"34330","name":"NewPresentation - Endorsement of new or updated applications for Enpr-EMA membership (Benjamin Pelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/newpresentation-endorsement-new-or-updated-applications-enpr-ema-membership-benjamin-pelle_en.pdf"},
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    {"id":"34347","name":"ICH: Q 4 B Annex 5: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-06-01T02:00:00Z","last_updated_date":"2008-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/308895/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-5-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-disintegration-test-general-chapter-step-3_en.pdf"},
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    {"id":"34356","name":"Opinion following an article 33(4)  referral for Fiprex CAT 52.5 mg spot-on solution for cats; Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for 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    {"id":"34388","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-05-08T14:00:00Z","last_updated_date":"2017-05-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-annex-iv_no.pdf"}},
    {"id":"34390","name":"Potassium and sodium salts of selenium: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-10-01T02:00:00Z","last_updated_date":"1997-10-01T02:00:00Z","reference_number":"EMEA/MRL/249/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/potassium-and-sodium-salts-selenium-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34391","name":"Proceedings of the workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T12:00:00Z","last_updated_date":"2016-01-07T12:00:00Z","reference_number":"EMA/803589/2015","document_url":"https://www.ema.europa.eu/en/documents/report/proceedings-workshop-role-pharmacokinetic-and-pharmacodynamic-measurements-use-direct-oral-anticoagulants_en.pdf"},
    {"id":"34393","name":"Agenda - 2012 European Medicines Agency/International Federation for Animal Health Europe info day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-01-30T01:00:00Z","last_updated_date":"2012-02-21T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2012-european-medicines-agencyinternational-federation-animal-health-europe-info-day_en.pdf"},
    {"id":"34395","name":"ESGCT/ICH Workshop on Viral Vector Shedding 1 - Klaus Cichutek","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/esgctich-workshop-viral-vector-shedding-1-klaus-cichutek_en.pdf"},
    {"id":"34396","name":"CVMP summary of positive opinion for Innovax-ILT","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-05-08T18:00:00Z","last_updated_date":"2015-05-08T18:00:00Z","reference_number":"EMA/235978/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-innovax-ilt_en.pdf"},
    {"id":"34397","name":"Opinion following an article 33 referral for Bovimectin Injection and its associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-13T02:00:00Z","last_updated_date":"2014-08-13T02:00:00Z","reference_number":"EMA/76071/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-33-referral-bovimectin-injection-and-its-associated-names_en.pdf"},
    {"id":"34398","name":"Important notice to tenderers - EMA-2012-09-IF external service providers for enterprise infrastructure support","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-30T15:06:00Z","last_updated_date":"2012-03-30T15:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/important-notice-tenderers-ema-2012-09-if-external-service-providers-enterprise-infrastructure-support_en.pdf"},
    {"id":"34400","name":"Public statement on Infergen (interferon alfacon-1): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2006-06-01T02:09:21Z","last_updated_date":"2006-06-01T02:09:21Z","reference_number":"EMEA/CHMP/192804/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-infergen-interferon-alfacon-1-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"34402","name":"Revision of section 6 of the 'Functional specifications for the European Union (EU) portal and EU database to be audited - EMA/42176/2014' setting out features to support making information public","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T11:00:00Z","last_updated_date":"2015-04-16T11:00:00Z","reference_number":"EMA/129363/2015","document_url":"https://www.ema.europa.eu/en/documents/other/revision-section-6-functional-specifications-european-union-eu-portal-and-eu-database-be-audited-ema421762014-setting-out-features-support-making-information-public_en.pdf"},
    {"id":"34406","name":"Doramectin (Modification of the MRLs): Summary report (6) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-07-01T02:00:00Z","last_updated_date":"2006-07-01T02:00:00Z","reference_number":"EMEA/CVMP/126676/6/2006-Final","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/doramectin-modification-mrls-summary-report-6-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34407","name":"CHMP summary of positive opinion for Prevenar 13","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/CHMP/546417/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-prevenar-13_en.pdf"},
    {"id":"34409","name":"Presentation - Croatia’s perspective on implementation of the new pharmacovigilance legislation (Marina Dimov Di Giusti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-croatias-perspective-implementation-new-pharmacovigilance-legislation-marina-dimov-di-giusti_en.pdf"},
    {"id":"34413","name":"CHMP positive summary of opinion for Telmisartan Actavis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2010-06-25T02:00:00Z","reference_number":"EMA/CHMP/372629/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-telmisartan-actavis_en.pdf"},
    {"id":"34415","name":"EU/3/11/932: Public summary of opinion on orphan designation: Pegylated proline-interferon alpha-2b for the treatment of polycythaemia vera","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/COMP/862741/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311932-public-summary-opinion-orphan-designation-pegylated-proline-interferon-alpha-2b-treatment-polycythaemia-vera_en.pdf"},
    {"id":"34416","name":"Presentation - FDA Reflections on Joint Regulators/Industry QbD Workshop (Christine M. V. Moore)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-reflections-joint-regulatorsindustry-qbd-workshop-christine-m-v-moore_en.pdf"},
    {"id":"34418","name":"Inauguration of the new committee on herbal medicinal products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-01-29T01:00:00Z","last_updated_date":"2004-01-29T01:00:00Z","reference_number":"HMPC/85420/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/inauguration-new-committee-herbal-medicinal-products_en.pdf"},
    {"id":"34420","name":"Semler Article-31 referral – CHMP list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/semler-article-31-referral-chmp-list-questions_en.pdf"},
    {"id":"34422","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171) for treatment of lower respiratory tract diseas...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-11-25T12:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/691347/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-nanobody-directed-towards-fusion-protein-human-respiratory-syncytial-virus-alx-0171-treatment-lower-respiratory-tract-diseas_en.pdf"},
    {"id":"34423","name":"Questions and answers on Haldol Decanoate and associated names (solution for injection)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T13:00:00Z","last_updated_date":"2017-05-11T14:00:00Z","reference_number":"EMA/122472/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-haldol-decanoate-and-associated-names-solution-injection_sv.pdf"}},
    {"id":"34424","name":"Note for guidance on harmonisation of requirements for influenza vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-03-12T01:00:00Z","last_updated_date":"1997-03-12T01:00:00Z","reference_number":"CPMP/BWP/214/96","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-harmonisation-requirements-influenza-vaccines_en.pdf"},
    {"id":"34426","name":"Highlights from the EMA Industry Platform meeting on the Operation of EU pharmacovigilance legislation – 13 March 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T13:56:00Z","last_updated_date":"2015-05-04T13:56:00Z","reference_number":"EMA/230906/2015","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-ema-industry-platform-meeting-operation-eu-pharmacovigilance-legislation-13-march-2015_en.pdf"},
    {"id":"34428","name":"Template for comments - Public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird populat...","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-09-12T19:30:00Z","last_updated_date":"2014-09-12T19:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-comments-public-consultation-regarding-request-european-medicines-agency-european-commission-scientific-opinion-regarding-risks-vultures-and-other-necrophagous-bird-populat_en.doc"},
    {"id":"34429","name":"Presentation - Session 2.2  - Working Group on Ethics (Pirkko Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-22-working-group-ethics-pirkko-lepola_en.pdf"},
    {"id":"34430","name":"Superseded Community herbal monograph on Rheum palmatum L. and Rheum officinale Baillon, radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T00:09:00Z","last_updated_date":"2020-08-18T00:09:00Z","reference_number":"EMEA/HMPC/189624/2007Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-rheum-palmatum-l-and-rheum-officinale-baillon-radix_en.pdf"},
    {"id":"34432","name":"EU/3/15/1591: Public summary of opinion on orphan designation: Synthetic peptide L-cysteine, L-cysteinylglycyl-L-glutaminyl-L-arginyl-L-.alpha.-glutamyl-L-threonyl-L-prolyl-L-.alpha.-glutamylglycyl-L-alanyl-L-.alpha.-glu...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-03T01:00:00Z","last_updated_date":"2016-02-03T01:00:00Z","reference_number":"EMA/COMP/794963/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151591-public-summary-opinion-orphan-designation-synthetic-peptide-l-cysteine-l-cysteinylglycyl-l-glutaminyl-l-arginyl-l-alpha-glutamyl-l-threonyl-l-prolyl-l-alpha-glutamylglycyl-l-alanyl-l-alpha_en.pdf"},
    {"id":"34434","name":"Presentation - Substance, Product, Organisation and Referential (SPOR) communication update (Agnieszka Laka, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-product-organisation-and-referential-spor-communication-update-agnieszka-laka-ema_en.pdf"},
    {"id":"34435","name":"Agenda - CAT agenda of the 16-17 January 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-01-20T18:25:00Z","last_updated_date":"2014-01-20T18:25:00Z","reference_number":"EMA/CAT/27142/2014 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-17-january-2014-meeting_en.pdf"},
    {"id":"34436","name":"Concept paper on the development of a committee for medicinal\n\nProducts for human use (CHMP) guideline on nonclinical testing for\n\nInadvertent germline transmission of gene transfer vectors","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-11-18T01:00:00Z","last_updated_date":"2004-11-18T01:00:00Z","reference_number":"EMEA/CHMP/SWP/110180/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-medicinal-products-human-use-chmp-guideline-nonclinical-testing-inadvertent-germline-transmission-gene-transfer-vectors_en.pdf"},
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    {"id":"34438","name":"Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-02-12T13:00:00Z","last_updated_date":"2016-02-12T13:00:00Z","reference_number":"EMA/85655/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/updated-recommendations-minimise-risk-rare-brain-infection-pml-tysabri_en.pdf"},
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    {"id":"34440","name":"Mycophenolate: updated recommendations for contraception for men and women","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-12-15T01:00:00Z","last_updated_date":"2017-12-15T01:00:00Z","reference_number":"EMA/828208/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/mycophenolate-updated-recommendations-contraception-men-and-women_en.pdf"},
    {"id":"34442","name":"Summary of transfers of appropriations in the budget 2009 - Management Board meeting: 11 June 2009","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-06-11T02:09:21Z","last_updated_date":"2009-06-11T02:09:21Z","reference_number":"EMEA/MB/90876/2009","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfers-appropriations-budget-2009-management-board-meeting-11-june-2009_en.pdf"},
    {"id":"34443","name":"EU/3/10/821: Public summary of opinion on orphan designation: Human heterologous liver cells (for infusion) for the treatment of carbamoyl-phosphate synthase-1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"EMA/COMP/636271/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310821-public-summary-opinion-orphan-designation-human-heterologous-liver-cells-infusion-treatment-carbamoyl-phosphate-synthase-1-deficiency_en.pdf"},
    {"id":"34445","name":"Frequently asked questions on phenylbutazone in horsemeat","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T12:00:00Z","last_updated_date":"2013-04-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-phenylbutazone-horsemeat_en.pdf"},
    {"id":"34446","name":"Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-14T13:22:00Z","last_updated_date":"2018-08-14T13:23:46Z","reference_number":"EMA/537197/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/glatiramer-list-nationally-authorised-medicinal-products-psusa00001529201711_en.pdf"},
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    {"id":"34449","name":"Work plan for Good Clinical Practice Inspectors Working Group 2016","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T16:35:00Z","last_updated_date":"2016-02-26T16:35:00Z","reference_number":"EMA/INS/GCP/752886/2015","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-good-clinical-practice-inspectors-working-group-2016_en.pdf"},
    {"id":"34450","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Leonurus cardiaca L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/HMPC/573554/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-leonurus-cardiaca-l-herba_en.pdf"},
    {"id":"34451","name":"Presentation - Risk management (S. Blackburn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-management-s-blackburn_en.pdf"},
    {"id":"34452","name":"Overview of comments received on 'Draft questions and answers on sodium'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-10-10T02:00:00Z","last_updated_date":"2017-10-10T02:00:00Z","reference_number":"EMA/CHMP/623211/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-questions-and-answers-sodium_en.pdf"},
    {"id":"34453","name":"Committee on herbal medicinal products (HMPC): Meeting report, 9-10 January 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-01-23T00:00:00Z","last_updated_date":"2008-01-23T00:00:00Z","reference_number":"EMEA/HMPC/29102/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-9-10-january-2008_en.pdf"},
    {"id":"34454","name":"CHMP and rapporteurs' joint assessment report template and assessment on similarity rev. 07.18","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-05-28T13:00:00Z","last_updated_date":"2018-07-26T11:30:00Z","reference_number":"Rev. 07.18","document_url":"https://www.ema.europa.eu/en/documents/template-form/chmp-and-rapporteurs-joint-assessment-report-template-and-assessment-similarity-rev-0718_en.doc"},
    {"id":"34456","name":"EU/3/09/711: Public summary of opinion on orphan designation of recombinant human vascular endothelial growth factor for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/749030/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309711-public-summary-opinion-orphan-designation-recombinant-human-vascular-endothelial-growth-factor-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"34459","name":"EU/3/01/059: Public summary of positive opinion for orphan designation of dexrazoxane for the treatment of anthracycline extravasation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2016-09-30T02:00:00Z","reference_number":"EMEA/COMP/256/2004 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301059-public-summary-positive-opinion-orphan-designation-dexrazoxane-treatment-anthracycline-extravasation_en.pdf"},
    {"id":"34463","name":"Public statement on Imprida HCT: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-10-22T02:00:00Z","last_updated_date":"2012-10-22T02:00:00Z","reference_number":"EMA/670070/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-imprida-hct-cessation-validity-marketing-authorisation-european-union_en.pdf"},
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    {"id":"34465","name":"Presentation - Monitoring methods and systems (Georg Himmelstjerna, Jà¼rgen Krà¼cken)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-methods-and-systems-georg-himmelstjerna-ja-14rgen-kra-14cken_en.pdf"},
    {"id":"34466","name":"Withdrawal assessment report for Faldaprevir Boehringer Ingelheim","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-09-16T02:00:00Z","last_updated_date":"2014-09-16T02:00:00Z","reference_number":"EMA/519229/2014","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-faldaprevir-boehringer-ingelheim_en.pdf"},
    {"id":"34467","name":"newList of participants of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-11T01:00:00Z","last_updated_date":"2015-12-11T01:00:00Z","reference_number":"EMA/407107/2015","document_url":"https://www.ema.europa.eu/en/documents/other/newlist-participants-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf"},
    {"id":"34471","name":"Presentation - Methods to go from process outcomes to health outcomes (Stephen Evans)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-methods-go-process-outcomes-health-outcomes-stephen-evans_en.pdf"},
    {"id":"34472","name":"Agenda - Committee for Advanced Therapies (CAT) and the International Society for Cellular Therapy (ISCT) workshop: challenges and opportunities for a successful development and approval of advanced therapy medicinal pro...","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-06-30T17:00:00Z","last_updated_date":"2015-06-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-committee-advanced-therapies-cat-and-international-society-cellular-therapy-isct-workshop-challenges-and-opportunities-successful-development-and-approval-advanced-therapy-medicinal-pro_en.pdf"},
    {"id":"34473","name":"PRAC meeting dates 2016, 2017 and 2018","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-24T01:00:00Z","last_updated_date":"2017-11-07T17:00:00Z","reference_number":"EMA/PRAC/105364/2013 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/other/prac-meeting-dates-2016-2017-and-2018_en.pdf"},
    {"id":"34475","name":"Presentation - Adaptive clinical trials with subgroup selection (Stallard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adaptive-clinical-trials-subgroup-selection-stallard_en.pdf"},
    {"id":"34477","name":"Public statement on Clopidogrel Teva Pharma: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMEA/H/C/001052","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-clopidogrel-teva-pharma-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"34478","name":"Presentation - Routine signal detection and statistical tools on paediatrics (Cosimo Zaccaria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-routine-signal-detection-and-statistical-tools-paediatrics-cosimo-zaccaria_en.pdf"},
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    {"id":"34482","name":"EMEA recommends authorisation of first pre-pandemic influenza vaccine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T00:09:21Z","last_updated_date":"2008-02-21T00:09:21Z","reference_number":"EMEA/CHMP/90694/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-authorisation-first-pre-pandemic-influenza-vaccine_en.pdf"},
    {"id":"34483","name":"Vancomycin Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-11-17T01:00:00Z","last_updated_date":"2017-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/vancomycin-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/vancomycin-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/vancomycin-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/vancomycin-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/vancomycin-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/vancomycin-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/vancomycin-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/vancomycin-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/vancomycin-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/vancomycin-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/vancomycin-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/vancomycin-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/vancomycin-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/vancomycin-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/vancomycin-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/vancomycin-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/vancomycin-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/vancomycin-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/vancomycin-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/vancomycin-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/vancomycin-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/vancomycin-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/vancomycin-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"34487","name":"CVMP summary of positive opinion for Vectormune ND","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-10T17:00:00Z","last_updated_date":"2015-07-10T17:00:00Z","reference_number":"EMA/CVMP/354791/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vectormune-nd_en.pdf"},
    {"id":"34488","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/417149/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-autologous-adipose-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"34489","name":"34th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1998-07-09T14:49:21Z","last_updated_date":"1998-07-09T14:49:21Z","reference_number":"EMEA/CVMP/350/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/34th-meeting-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34490","name":"Announcement - 2012 European Medicines Agency/International Federation for Animal Health Europe info day","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T12:55:00Z","last_updated_date":"2011-12-19T12:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/announcement-2012-european-medicines-agencyinternational-federation-animal-health-europe-info-day_en.pdf"},
    {"id":"34491","name":"Technical specifications - Annex IV draft service contract: Procurement procedure EMA/2014/49/AUD","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2014-12-10T10:00:00Z","last_updated_date":"2014-12-10T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/technical-specifications-annex-iv-draft-service-contract-procurement-procedure-ema201449aud_en.pdf"},
    {"id":"34494","name":"Presentation - 4.1 A value-of-information approach to sample size determination in confirmatory clinical trials in small populations (Nigel Stallard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-41-value-information-approach-sample-size-determination-confirmatory-clinical-trials-small-populations-nigel-stallard_en.pdf"},
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    {"id":"34499","name":"Zydelig Article-20 procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T18:00:00Z","last_updated_date":"2016-10-03T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zydelig-article-20-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zydelig-article-20-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zydelig-article-20-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zydelig-article-20-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zydelig-article-20-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zydelig-article-20-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zydelig-article-20-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zydelig-article-20-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zydelig-article-20-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zydelig-article-20-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zydelig-article-20-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zydelig-article-20-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zydelig-article-20-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zydelig-article-20-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zydelig-article-20-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zydelig-article-20-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zydelig-article-20-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zydelig-article-20-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zydelig-article-20-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zydelig-article-20-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zydelig-article-20-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zydelig-article-20-procedure-annex-iv_sv.pdf"}},
    {"id":"34500","name":"Presentation - Session 3.8: European Reference Networks (Enrique Terol)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-38-european-reference-networks-enrique-terol_en.pdf"},
    {"id":"34502","name":"Testosterone Article-31 referral - PRAC review does not confirm increase in heart problems with testosterone medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T14:00:00Z","last_updated_date":"2014-10-10T14:00:00Z","reference_number":"EMA/611318/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/testosterone-article-31-referral-prac-review-does-not-confirm-increase-heart-problems-testosterone-medicines_en.pdf"},
    {"id":"34504","name":"CHMP summary of positive opinion for Desloratadine Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/749646/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-desloratadine-teva_en.pdf"},
    {"id":"34505","name":"Presentation - Agenda item 1: update from the industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-10-29T01:00:00Z","last_updated_date":"2015-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-item-1-update-industry_en.pdf"},
    {"id":"34507","name":"Spiramycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-07-24T02:00:00Z","last_updated_date":"1997-07-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spiramycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34508","name":"Valebo and associated names Article-29(4) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-31T03:00:00Z","last_updated_date":"2014-03-31T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/valebo-and-associated-names-article-294-referral-annex-i_sv.pdf"}},
    {"id":"34510","name":"EU/3/12/987: Public summary of opinion on orphan designation: (E)-2,4,6-trimethoxystyryl-3-carboxymethylamino-4-methoxybenzyl-sulfone sodium salt for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2021-10-27T11:30:00Z","reference_number":"EMA/COMP/217857/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312987-public-summary-opinion-orphan-designation-e-246-trimethoxystyryl-3-carboxymethylamino-4-methoxybenzyl-sulfone-sodium-salt-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"34511","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T01:00:00Z","last_updated_date":"2017-03-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-annex-iv_sv.pdf"}},
    {"id":"34512","name":"EU/3/02/103: Public summary of positive opinion for orphan designation of recombinant human porphobilinogen deaminase for the treatment of acute intermittent porphyria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-01-08T00:00:00Z","last_updated_date":"2020-08-12T00:00:00Z","reference_number":"EMEA/COMP/843/02 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302103-public-summary-positive-opinion-orphan-designation-recombinant-human-porphobilinogen-deaminase-treatment-acute-intermittent-porphyria_en.pdf"},
    {"id":"34515","name":"Declaration of interests: Anabela Luis de Lima Marcal","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:00Z","last_updated_date":"2019-10-25T10:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-anabela-luis-de-lima-marcal_en.pdf"},
    {"id":"34516","name":"EU/3/10/737: Public summary of opinion on orphan designation: Glyceryl tri-(4-phenylbutyrate) for the treatment of hyperargininaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"EMA/COMP/123476/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310737-public-summary-opinion-orphan-designation-glyceryl-tri-4-phenylbutyrate-treatment-hyperargininaemia_en.pdf"},
    {"id":"34518","name":"Presentation - Clinical Researchers, Eugene Major","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-researchers-eugene-major_en.pdf"},
    {"id":"34521","name":"Triclabendazole: Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-25T02:00:00Z","last_updated_date":"1998-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/triclabendazole-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"34527","name":"Public statement on Arepanrix: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2011-01-18T01:00:00Z","last_updated_date":"2011-01-18T01:00:00Z","reference_number":"EMA/22596/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-arepanrix-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"34535","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human burn eschar and debrided adipose tissue cells (on acellular dermal matrix)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T11:00:00Z","last_updated_date":"2018-02-13T11:00:00Z","reference_number":"EMA/35702/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-burn-eschar-and-debrided-adipose-tissue-cells-acellular-dermal-matrix_en.pdf"},
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    {"id":"34566","name":"European Medicines Agency adopts first positive opinion for mock-up pandemic influenza vaccine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-12-15T00:09:21Z","last_updated_date":"2006-12-15T00:09:21Z","reference_number":"EMEA/502873/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-adopts-first-positive-opinion-mock-pandemic-influenza-vaccine_en.pdf"},
    {"id":"34568","name":"EU/3/14/1260: Public summary of opinion on orphan designation: Fixed-dose combination of (R-S) baclofen, naltrexone hydrochloride and D-sorbitol for the treatment of Charcot-Marie-Tooth disease type 1A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-07T02:00:00Z","last_updated_date":"2014-05-07T02:00:00Z","reference_number":"EMA/COMP/94332/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141260-public-summary-opinion-orphan-designation-fixed-dose-combination-r-s-baclofen-naltrexone-hydrochloride-and-d-sorbitol-treatment-charcot-marie-tooth-disease-type-1a_en.pdf"},
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    {"id":"34570","name":"Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-29T17:55:00Z","last_updated_date":"2017-09-29T17:56:00Z","reference_number":"EMA/639158/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-hydrochloride-chlordiazepoxide-list-nationally-authorised-medicinal-products-psusa00000171201702_en.pdf"},
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    {"id":"34607","name":"EU/3/07/461: Public summary of positive opinion for orphan designation of human plasminogen for the treatment of ligneous conjunctivitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-01-17T01:00:00Z","last_updated_date":"2008-01-17T01:00:00Z","reference_number":"EMEA/COMP/285792/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307461-public-summary-positive-opinion-orphan-designation-human-plasminogen-treatment-ligneous-conjunctivitis_en.pdf"},
    {"id":"34608","name":"Guideline on development, production, characterisation and specification for monoclonal antibodies and related products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-08-05T12:00:00Z","last_updated_date":"2016-08-05T12:00:00Z","reference_number":"EMA/CHMP/BWP/532517/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-production-characterisation-and-specification-monoclonal-antibodies-and-related-products-revision-1_en.pdf"},
    {"id":"34609","name":"Minutes of the European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting of 7 May 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"EMA/296167/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-7-may-2012_en.pdf"},
    {"id":"34610","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-13 October 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-10-15T02:00:00Z","last_updated_date":"2010-10-15T02:00:00Z","reference_number":"EMA/CVMP/609594/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-12-13-october-2010_en.pdf"},
    {"id":"34612","name":"Atacand plus - Article 30 referral - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-09-20T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/atacand-plus-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/atacand-plus-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/atacand-plus-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/atacand-plus-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/atacand-plus-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/atacand-plus-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/atacand-plus-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/atacand-plus-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/atacand-plus-article-30-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/atacand-plus-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/atacand-plus-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/atacand-plus-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/atacand-plus-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/atacand-plus-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/atacand-plus-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/atacand-plus-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/atacand-plus-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/atacand-plus-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/atacand-plus-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/atacand-plus-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/atacand-plus-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/atacand-plus-article-30-referral-annex-i_sv.pdf"}},
    {"id":"34616","name":"EU/3/10/744: Public summary of positive opinion on orphan designation Adrenomedullin for the treatment of acute lung injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2011-11-18T01:00:00Z","reference_number":"EMA/COMP/169921/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310744-public-summary-positive-opinion-orphan-designation-adrenomedullin-treatment-acute-lung-injury_en.pdf"},
    {"id":"34617","name":"Public statement on prioritisation for assessment of herbal substances associated with safety concerns","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2014-11-24T12:10:00Z","last_updated_date":"2015-10-23T12:46:00Z","reference_number":"EMA/HMPC/682247/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-prioritisation-assessment-herbal-substances-associated-safety-concerns_en.pdf"},
    {"id":"34618","name":"Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-03-29T02:09:21Z","last_updated_date":"2004-03-29T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/commission-directive-200433ec-22-march-2004-implementing-directive-200298ec-european-parliament-and-council-regards-certain-technical-requirements-blood-and-blood-components_en.pdf"},
    {"id":"34619","name":"Annex - Replies to EFSA/EMA questions on the use of antimicrobials in food-producing animals in EU and possible measures to reduce antimicrobial use","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-01-24T10:59:00Z","last_updated_date":"2017-01-24T10:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/annex-replies-efsaema-questions-use-antimicrobials-food-producing-animals-eu-and-possible-measures-reduce-antimicrobial-use_en.pdf"},
    {"id":"34620","name":"Superseded overview of comments received on Community herbal monograph on Hedera helix L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2012-01-19T01:00:00Z","last_updated_date":"2016-01-18T01:00:00Z","reference_number":"EMA/HMPC/570419/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-hedera-helix-l-folium_en.pdf"},
    {"id":"34621","name":"Monitoring medical literature EVWEB literature test cases XML format","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-30T14:00:00Z","last_updated_date":"2015-06-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/monitoring-medical-literature-evweb-literature-test-cases-xml-format_en.zip"},
    {"id":"34624","name":"Inventory of herbal substances for assessment","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-10-25T02:00:00Z","last_updated_date":"2021-07-05T13:17:00Z","reference_number":"EMA/HMPC/494079/2007","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-herbal-substances-assessment_en.pdf"},
    {"id":"34626","name":"Guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T11:39:00Z","last_updated_date":"2012-07-06T11:39:00Z","reference_number":"EMA/CHMP/330418/2012 rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-parkinsons-disease_en.pdf-0"},
    {"id":"34627","name":"EU/3/16/1663: Public summary of opinion on orphan designation: Pentosan polysulfate sodium for the treatment of interstitial cystitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-22T02:00:00Z","last_updated_date":"2016-06-22T02:00:00Z","reference_number":"EMA/COMP/310632/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161663-public-summary-opinion-orphan-designation-pentosan-polysulfate-sodium-treatment-interstitial-cystitis_en.pdf"},
    {"id":"34631","name":"Committee for Medicinal Products for Human Use (CHMP) - December 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-01-16T01:00:00Z","last_updated_date":"2006-01-16T01:00:00Z","reference_number":"EMEA/CHMP/420100/2005, rev 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-december-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"34633","name":"Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:00:00Z","last_updated_date":"2016-08-15T12:00:00Z","reference_number":"EMA/168402/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-product-or-population-specific-considerations-ii-biological-medicinal-products-tracked-changes_en.pdf"},
    {"id":"34635","name":"CVMP summary of positive opinion for Vectra Felis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-04-11T18:00:00Z","last_updated_date":"2014-04-11T18:00:00Z","reference_number":"EMA/CVMP/158566/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vectra-felis_en.pdf"},
    {"id":"34636","name":"Presentation - Working group on young people advisory groups","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-06T01:00:00Z","last_updated_date":"2017-03-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-young-people-advisory-groups_en.pdf"},
    {"id":"34637","name":"European Medicines Agency recommends measures to manage contamination of heparin-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-05T02:09:21Z","last_updated_date":"2008-06-05T02:09:21Z","reference_number":"EMEA/CHMP/277722/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-measures-manage-contamination-heparin-containing-medicines_en.pdf"},
    {"id":"34638","name":"Scientific recommendation on classification of advanced therapy medicinal products: co-culture of keratinocytes and mesenchymal stem cells isolated from umbilical cord  seeded on acellular dermal matrix","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T17:00:00Z","last_updated_date":"2016-04-12T17:00:00Z","reference_number":"EMA/240998/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-co-culture-keratinocytes-and-mesenchymal-stem-cells-isolated-umbilical-cord-seeded-acellular-dermal-matrix_en.pdf-0"},
    {"id":"34640","name":"Presentation - Introduction to ALIMS (Pavle Zelic)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-alims-pavle-zelic_en.pdf"},
    {"id":"34641","name":"Final list of references supporting the assessment of Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2012-07-10T14:00:00Z","last_updated_date":"2012-07-10T14:00:00Z","reference_number":"EMA/HMPC/337076/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-or-their-mixtures-flos-first-version_en.pdf"},
    {"id":"34645","name":"European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-06-12T02:00:00Z","last_updated_date":"2014-06-12T02:00:00Z","reference_number":"EMA/348985/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-agrees-policy-publication-clinical-trial-data-more-user-friendly-amendments_en.pdf"},
    {"id":"34648","name":"EU/3/09/652: Public summary of positive opinion for orphan designation of ciprofloxacin (liposomal) for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-11T02:00:00Z","last_updated_date":"2009-09-11T02:00:00Z","reference_number":"EMEA/COMP/362878/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309652-public-summary-positive-opinion-orphan-designation-ciprofloxacin-liposomal-treatment-cystic-fibrosis_en.pdf"},
    {"id":"34649","name":"CHMP summary of positive opinion for Myalepta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/352612/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-myalepta_en.pdf"},
    {"id":"34650","name":"EU/3/15/1499: Public summary of opinion on orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells for treatment of thromboangiitis obliterans (Buerger's disease...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-06-30T02:00:00Z","last_updated_date":"2015-06-30T02:00:00Z","reference_number":"EMA/COMP/274387/2015 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151499-public-summary-opinion-orphan-designation-adult-human-bone-marrow-derived-ex-vivo-expanded-pooled-allogeneic-mesenchymal-stromal-cells-treatment-thromboangiitis-obliterans-buergers-disease_en.pdf"},
    {"id":"34652","name":"Committee for medicinal products for human use, summary of positive opinion for Ixiaro","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2008-12-18T01:00:00Z","reference_number":"EMEA/CHMP/662316/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-ixiaro_en.pdf"},
    {"id":"34653","name":"Flutiform - Article 29 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-10-25T02:00:00Z","last_updated_date":"2012-10-25T02:00:00Z","reference_number":"EMA/399193/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/flutiform-article-29-referral-assessment-report_en.pdf"},
    {"id":"34655","name":"ICH: S 1 A: The need for carcinogenicity studies of pharmaceuticals - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1996-07-01T02:09:21Z","last_updated_date":"1996-07-01T02:09:21Z","reference_number":"CPMP/ICH/140/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-1-need-carcinogenicity-studies-pharmaceuticals-step-5_en.pdf"},
    {"id":"34656","name":"Presentation - Model Informed Drug Discovery and Development (MID3) Good Practice: use of prior knowledge and setting up assumptions (Scott Marshall, \n\nLutz Harnisch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-model-informed-drug-discovery-and-development-mid3-good-practice-use-prior-knowledge-and-setting-assumptions-scott-marshall-lutz-harnisch_en.pdf"},
    {"id":"34659","name":"Beclometasone / salbutamol : List of nationally authorised medicinal products - PSUSA/00000309/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T11:31:00Z","last_updated_date":"2017-09-08T11:34:26Z","reference_number":"EMA/596710/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/beclometasone-salbutamol-list-nationally-authorised-medicinal-products-psusa00000309201701_en.pdf"},
    {"id":"34660","name":"Questions and answers on the recommendation for the refusal of a marketing authorisation application for Sumitriptan Galpharm 50 mg tablets","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/CHMP/423166/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-recommendation-refusal-marketing-authorisation-application-sumitriptan-galpharm-50-mg-tablets_en.pdf"},
    {"id":"34661","name":"Use of transgenic animals in the manufacture of biological medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1995-07-01T02:00:00Z","last_updated_date":"1995-07-01T02:00:00Z","reference_number":"III/3612/93","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/use-transgenic-animals-manufacture-biological-medicinal-products-human-use_en.pdf"},
    {"id":"34662","name":"Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-10T02:00:00Z","last_updated_date":"2016-10-17T19:03:13Z","reference_number":"EMA/540382/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-topical-use-list-nationally-authorised-medicinal-products-psusa00010376201510_en.pdf"},
    {"id":"34665","name":"Presentation - The International Consortium for Personalised Medicine (PerMed) - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-consortium-personalised-medicine-permed-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"34666","name":"Opinion following an Article 10 referral Cyklo-f International Non-Proprietary Name (INN): Tranexamic acid: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2000-07-27T02:08:21Z","last_updated_date":"2000-07-27T02:08:21Z","reference_number":"CPMP/902/00","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-10-referral-cyklo-f-international-non-proprietary-name-inn-tranexamic-acid-background-information_en.pdf"},
    {"id":"34668","name":"EU/3/10/837: Public summary of opinion on orphan designation: Plitidepsin for the treatment of primary myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-07T01:00:00Z","last_updated_date":"2011-09-06T02:00:00Z","reference_number":"EMA/COMP/740395/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310837-public-summary-opinion-orphan-designation-plitidepsin-treatment-primary-myelofibrosis_en.pdf"},
    {"id":"34670","name":"Presentation - Challenges developing an RSV therapeutic in paediatrics (Matthew W. McClure)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-developing-rsv-therapeutic-paediatrics-matthew-w-mcclure_en.pdf"},
    {"id":"34672","name":"Presentation - Interaction with patients and consumers: Overview of involvement in EMA activities during 2015 (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-patients-and-consumers-overview-involvement-ema-activities-during-2015-nathalie-bere_en.pdf"},
    {"id":"34673","name":"Withdrawal assessment report for Beprana","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-10-06T18:24:00Z","last_updated_date":"2011-10-06T18:24:00Z","reference_number":"EMA/657046/2011","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-beprana_en.pdf"},
    {"id":"34676","name":"Superseded opinion of the community on herbal medicinal products on a community herbal monograph on Verbascum thapsus L., V. densiflorum Bertol and V. phlomoides L., flos","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/HMPC/188000/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-community-herbal-medicinal-products-community-herbal-monograph-verbascum-thapsus-l-v-densiflorum-bertol-and-v-phlomoides-l-flos_en.pdf"},
    {"id":"34679","name":"Presentation - Cell-based products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cell-based-products_en.pdf"},
    {"id":"34681","name":"Presentation - Workshop on patient's voice in the evaluation of medicines -European Register for Multiple Sclerosis: Pooling European data to better understand and fight multiple sclerosis (Christoph Thalheim)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T01:00:00Z","last_updated_date":"2013-10-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-patients-voice-evaluation-medicines-european-register-multiple-sclerosis-pooling-european-data-better-understand-and-fight-multiple-sclerosis-christoph-thalheim_en.pdf"},
    {"id":"34682","name":"Draft guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-06T02:00:00Z","last_updated_date":"2008-05-06T02:00:00Z","reference_number":"EMEA/149995/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-safety-and-efficacy-follow-risk-management-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"34686","name":"Presentation - Use of dose-exposure-response model in immunology/transplantation: general considerations and case study (T Dumortier, M Looby, Y Wang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T01:00:00Z","last_updated_date":"2015-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-dose-exposure-response-model-immunologytransplantation-general-considerations-and-case-study-t-dumortier-m-looby-y-wang_en.pdf"},
    {"id":"34688","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - November 2008","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2008-11-30T01:00:00Z","last_updated_date":"2008-11-30T01:00:00Z","reference_number":"EMEA/666257/2008","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-november-2008_en.pdf"},
    {"id":"34690","name":"Presentation - Pediatric inflammatory bowel disease clinical trials: is there a role for placebo? (Athos Bousvaros)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pediatric-inflammatory-bowel-disease-clinical-trials-there-role-placebo-athos-bousvaros_en.pdf"},
    {"id":"34693","name":"EU/3/14/1314: Public summary of opinion on orphan designation: Recombinant human apolipoprotein A-I in a complex with phospholipids for the treatment of ATP-binding cassette transporter A1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/COMP/434435/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141314-public-summary-opinion-orphan-designation-recombinant-human-apolipoprotein-i-complex-phospholipids-treatment-atp-binding-cassette-transporter-a1-deficiency_en.pdf"},
    {"id":"34700","name":"Superseded list of references supporting the assessment report on: Rusci aculeati rhizoma Ruscus aculeatus L., rhizoma (butcher's broom)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2019-05-02T17:00:00Z","reference_number":"EMEA/HMPC/372915/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-rusci-aculeati-rhizoma-ruscus-aculeatus-l-rhizoma-butchers-broom_en.pdf"},
    {"id":"34701","name":"CHMP summary of positive opinion for Kyntheum","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-05-19T02:00:00Z","last_updated_date":"2017-05-19T02:00:00Z","reference_number":"EMA/CHMP/714138/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-kyntheum_en.pdf"},
    {"id":"34702","name":"Presentation - Quality systems for pharmacovigilance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-03T17:30:00Z","last_updated_date":"2012-05-03T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-systems-pharmacovigilance_en.pdf"},
    {"id":"34703","name":"Direct-acting antivirals for hepatitis C Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-18T13:00:00Z","last_updated_date":"2016-03-18T13:00:00Z","reference_number":"EMA/PRAC/188631/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/direct-acting-antivirals-hepatitis-c-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"34706","name":"Overview of comments received on questions and answers on notification to the EMEA of actual marketing and cessation of placing on the market for centrally authorised medicinal products","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-02-23T01:00:00Z","last_updated_date":"2006-02-23T01:00:00Z","reference_number":"EMEA/424223/2005","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/overview-comments-received-questions-and-answers-notification-emea-actual-marketing-and-cessation-placing-market-centrally-authorised-medicinal-products_en.pdf"},
    {"id":"34708","name":"EU/3/16/1752: Public summary of positive opinion for orphan designation of human monoclonal IgG1 antibody against tissue factor pathway inhibitor for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2017-03-01T01:00:00Z","reference_number":"EMA/615269/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161752-public-summary-positive-opinion-orphan-designation-human-monoclonal-igg1-antibody-against-tissue-factor-pathway-inhibitor-treatment-haemophilia_en.pdf"},
    {"id":"34709","name":"EU/3/18/2013: Public summary of opinion on orphan designation: Polatuzumab vedotin for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T13:00:00Z","last_updated_date":"2018-05-17T13:00:00Z","reference_number":"EMA/178440/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182013-public-summary-opinion-orphan-designation-polatuzumab-vedotin-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"34710","name":"Overview of comments received on guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-04T14:00:00Z","last_updated_date":"2014-03-04T14:00:00Z","reference_number":"EMA/CHMP/BWP/574033/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-use-porcine-trypsin-used-manufacture-human-biological-medicinal-products_en.pdf"},
    {"id":"34713","name":"Presentation - Current status and update of the Article 57(2) implementation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-status-and-update-article-572-implementation_en.pdf"},
    {"id":"34714","name":"Presentation: Successful IMI project: INNODIA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-successful-imi-project-innodia_en.pdf"},
    {"id":"34715","name":"Presentation - 3.2 Adaptive levels of evidence: an extrapolation framework to specify requirements for drug development in children (Franz Konig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-32-adaptive-levels-evidence-extrapolation-framework-specify-requirements-drug-development-children-franz-k%7Fonig_en.pdf"},
    {"id":"34716","name":"Final assessment report on Rubus idaeus L., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T11:00:00Z","last_updated_date":"2014-03-21T11:00:00Z","reference_number":"EMA/HMPC/44209/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-rubus-idaeus-l-folium_en.pdf"},
    {"id":"34717","name":"Gluscan 500 - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-23T02:08:21Z","last_updated_date":"2009-06-23T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gluscan-500-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"34719","name":"PRAC recommends restriction in the use of Protelos / Osseor: Questions and answers","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-04-12T14:00:00Z","last_updated_date":"2013-04-12T14:00:00Z","reference_number":"EMA/220628/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/prac-recommends-restriction-use-protelos-osseor-questions-and-answers_en.pdf"},
    {"id":"34722","name":"Committee on herbal medicinal products (HMPC): Meeting report, 8 May 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-05-21T02:00:00Z","last_updated_date":"2007-05-21T02:00:00Z","reference_number":"EMEA/HMPC/216295/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-8-may-2007_en.pdf"},
    {"id":"34725","name":"Pharmacovigilance and Risk Assessment Committee (PRAC): Consultation procedure on final composition and replacement of members/alternates","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T13:00:00Z","last_updated_date":"2012-04-02T13:00:00Z","reference_number":"EMA/MB/139702/2012","document_url":"https://www.ema.europa.eu/en/documents/other/pharmacovigilance-and-risk-assessment-committee-prac-consultation-procedure-final-composition-and-replacement-membersalternates_en.pdf"},
    {"id":"34726","name":"Hydrocortisone aceponate: European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2016-09-20T18:00:00Z","last_updated_date":"2016-09-20T18:00:00Z","reference_number":"EMA/CVMP/89165/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hydrocortisone-aceponate-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"34727","name":"2016 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2017-05-10T12:00:00Z","last_updated_date":"2017-05-29T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/2016-annual-report-european-medicines-agency_en.pdf"},
    {"id":"34730","name":"Presentation - EMA’s collaboration with Health Technology Assessment bodies (Hans-Georg Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T01:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-collaboration-health-technology-assessment-bodies-hans-georg-eichler_en.pdf"},
    {"id":"34731","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Onivyde (irinotecan) for the treatment of pancreatic cancer","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-11-11T17:00:00Z","last_updated_date":"2016-11-11T17:00:00Z","reference_number":"EMA/COMP/639247/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-onivyde-irinotecan-treatment-pancreatic-cancer_en.pdf"},
    {"id":"34732","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 16-19 July 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-07-27T11:40:00Z","last_updated_date":"2012-07-27T11:40:00Z","reference_number":"EMA/CHMP/410523/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-16-19-july-2012_en.pdf"},
    {"id":"34733","name":"Betaxolol: List of nationally authorised medicinal products - PSUSA/00000401/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-19T13:00:00Z","last_updated_date":"2018-01-19T13:00:00Z","reference_number":"EMA/21070/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/betaxolol-list-nationally-authorised-medicinal-products-psusa00000401201705_en.pdf"},
    {"id":"34734","name":"Ark Therapeutics Ltd withdraws its marketing authorisation application for Cerepro (sitimagene ceradenovec)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-11T01:00:00Z","last_updated_date":"2010-03-11T01:00:00Z","reference_number":"EMA/151854/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/ark-therapeutics-ltd-withdraws-its-marketing-authorisation-application-cerepro-sitimagene-ceradenovec_en.pdf"},
    {"id":"34736","name":"CVMP assessment report under Article 30(3) of Regulation (EC) No 726/2004 on the risk to vultures and other necrophagous bird populations in the European Union in connection with the use of veterinary medicinal products ...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T18:30:00Z","last_updated_date":"2014-12-12T18:30:00Z","reference_number":"EMA/CVMP/721170/2014","document_url":"https://www.ema.europa.eu/en/documents/report/cvmp-assessment-report-under-article-303-regulation-ec-no-7262004-risk-vultures-and-other-necrophagous-bird-populations-european-union-connection-use-veterinary-medicinal-products_en.pdf"},
    {"id":"34738","name":"Clonazepam: List of nationally authorised medicinal products - PSUSA/00000812/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-22T13:00:00Z","last_updated_date":"2016-10-17T20:16:36Z","reference_number":"EMA/146245/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/clonazepam-list-nationally-authorised-medicinal-products-psusa00000812201506_en.pdf"},
    {"id":"34739","name":"Reflection paper on meticillin-resistant Staphylococcus pseudintermedius","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-02-10T01:00:00Z","last_updated_date":"2011-02-10T01:00:00Z","reference_number":"EMA/CVMP/SAGAM/736964/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-meticillin-resistant-staphylococcus-pseudintermedius_en.pdf"},
    {"id":"34740","name":"Overview of comments on qualification opinion ILSI / HESI submission of novel renal biomarkers for toxicity","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-11-26T01:00:00Z","last_updated_date":"2010-11-26T01:00:00Z","reference_number":"EMA/CHMP/SAWP/627644/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-qualification-opinion-ilsi-hesi-submission-novel-renal-biomarkers-toxicity_en.pdf"},
    {"id":"34741","name":"Phloroglucinol trimethylphloroglucinol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/046/95-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phloroglucinol-trimethylphloroglucinol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34743","name":"Presentation - Findings from the PCWP/HCPWP topic group on social media (Donald Singer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-findings-pcwphcpwp-topic-group-social-media-donald-singer_en.pdf"},
    {"id":"34744","name":"Presentation - Topic 3 - Clinical development strategies and trial designs for new TB treatment regimens, Bedaquiline case study (Myriam Theeuwes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-3-clinical-development-strategies-and-trial-designs-new-tb-treatment-regimens-bedaquiline-case-study-myriam-theeuwes_en.pdf"},
    {"id":"34748","name":"EMA recommends additional measures to prevent use of mycophenolate in pregnancy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/680077/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-additional-measures-prevent-use-mycophenolate-pregnancy_en.pdf"},
    {"id":"34758","name":"PRAC recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-11-07T01:00:00Z","last_updated_date":"2014-11-07T01:00:00Z","reference_number":"EMA/676096/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-measures-reduce-risk-heart-problems-corlentorprocoralan-ivabradine_en.pdf"},
    {"id":"34759","name":"European Committee for Homeopathy - Contribution to discussion at homeopathic workshop","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-committee-homeopathy-contribution-discussion-homeopathic-workshop_en.pdf"},
    {"id":"34760","name":"EU/3/16/1817: Public summary of opinion on orphan designation: Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/4679/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161817-public-summary-opinion-orphan-designation-human-donor-haematopoietic-stem-and-progenitor-cells-have-been-treated-ex-vivo-protein-transduction-domain-hiv-1-transactivation-protein_en.pdf"},
    {"id":"34762","name":"Final Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-07-10T14:00:00Z","last_updated_date":"2012-07-10T14:00:00Z","reference_number":"EMA/HMPC/337066/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-or-their-mixtures-flos-first-version_en.pdf"},
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    {"id":"34793","name":"Report on the 10th anniversary of the SME initiative","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-11T12:30:00Z","last_updated_date":"2016-05-11T12:30:00Z","reference_number":"EMA/155560/2016","document_url":"https://www.ema.europa.eu/en/documents/report/report-10th-anniversary-sme-initiative_en.pdf"},
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    {"id":"34802","name":"European Medicines Agency advises on compassionate use of daclatasvir","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/719859/2013 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-advises-compassionate-use-daclatasvir_en.pdf"},
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    {"id":"34805","name":"Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators with tracked changes (Rev. 2)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-03-30T17:00:00Z","last_updated_date":"2017-03-30T17:00:00Z","reference_number":"EMA/204715/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools-and-effectiveness-indicators-tracked-changes-rev-2_en.pdf"},
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    {"id":"34819","name":"Terpenic derivatives - Article 31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-02-08T01:00:00Z","last_updated_date":"2012-02-08T01:00:00Z","reference_number":"EMEA/H/A-1284","document_url":"https://www.ema.europa.eu/en/documents/referral/terpenic-derivatives-article-31-referral-assessment-report_en.pdf"},
    {"id":"34820","name":"Note for guidance on clinical investigation of medicinal products for treatment of depression - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-04-25T02:00:00Z","last_updated_date":"2002-04-25T02:00:00Z","reference_number":"CPMP/EWP/518/97, Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-depression-revision-1_en.pdf"},
    {"id":"34822","name":"California poppy - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"EMA/HMPC/334023/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/california-poppy-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/california-poppy-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/california-poppy-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/california-poppy-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/california-poppy-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/california-poppy-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/california-poppy-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/california-poppy-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/california-poppy-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/california-poppy-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/california-poppy-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/california-poppy-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/california-poppy-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/california-poppy-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/california-poppy-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/california-poppy-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/california-poppy-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/california-poppy-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/california-poppy-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/california-poppy-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/california-poppy-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/california-poppy-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/california-poppy-summary-public_sv.pdf"}},
    {"id":"34823","name":"EU/3/17/1971: Public summary of opinion on orphan designation: Vatiquinone for the treatment of RARS2 syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/829780/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171971-public-summary-opinion-orphan-designation-vatiquinone-treatment-rars2-syndrome_en.pdf"},
    {"id":"34827","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 February 2015","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-02-13T01:00:00Z","last_updated_date":"2015-02-13T01:00:00Z","reference_number":"EMA/CVMP/60802/2015 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-february-2015_en.pdf"},
    {"id":"34828","name":"Registration request for the workshop on extrapolation of efficacy and safety in medicine development across age groups","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-14T17:50:00Z","last_updated_date":"2016-03-01T17:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/registration-request-workshop-extrapolation-efficacy-and-safety-medicine-development-across-age-groups_en.pdf"},
    {"id":"34831","name":"Overview of comments received on 'Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)' (EMEA/CHMP/EWP/431734/2008)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-08-05T02:00:00Z","last_updated_date":"2010-08-05T02:00:00Z","reference_number":"EMEA/CHMP/EWP/431734/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-clinical-investigation-medicinal-products-treatment-attention-deficit-hyperactivity-disorder-adhd-emeachmpewp4317342008_en.pdf"},
    {"id":"34834","name":"Calcichew D3 mite - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-01-22T00:08:21Z","last_updated_date":"2004-01-22T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/calcichew-d3-mite-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"34835","name":"Questions and answers on the review of medicines containing valproate for use in bipolar disorder","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-12-19T00:59:00Z","last_updated_date":"2011-04-30T01:59:00Z","reference_number":"EMA/809287/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_bg.pdf-0","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_es.pdf-0","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_cs.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_de.pdf-0","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_et.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_fr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_it.pdf-0","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_lv.pdf-0","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_lt.pdf-0","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_hu.pdf-0","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_mt.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_nl.pdf-0","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_pl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_pt.pdf-0","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_ro.pdf-0","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_sk.pdf-0","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_sl.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-medicines-containing-valproate-use-bipolar-disorder_sv.pdf-0"}},
    {"id":"34836","name":"EU/3/15/1480: Public summary of positive opinion for orphan designation of Rintatolimod for the treatment of Ebola virus disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-22T13:00:00Z","last_updated_date":"2015-05-22T13:00:00Z","reference_number":"EMA/COMP/204227/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151480-public-summary-positive-opinion-orphan-designation-rintatolimod-treatment-ebola-virus-disease_en.pdf"},
    {"id":"34839","name":"Presentation - Topic 4 - Improving the handling of paediatric investigation plan (PIP) applications: Industry perspective - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (G...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-4-improving-handling-paediatric-investigation-plan-pip-applications-industry-perspective-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-g_en.pdf"},
    {"id":"34840","name":"EU/3/00/015: Public summary of positive opinion for orphan designation of xaliproden hydrochloride for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-12T00:00:00Z","last_updated_date":"2011-05-07T01:00:00Z","reference_number":"EMEA/COMP/1275/03 draft Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300015-public-summary-positive-opinion-orphan-designation-xaliproden-hydrochloride-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"34842","name":"Canagliflozin Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/canagliflozin-article-20-procedure-notification_en.pdf"},
    {"id":"34843","name":"Start of community reviews - CHMP meeting of 18-21 March 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-22T01:00:00Z","last_updated_date":"2013-03-22T01:00:00Z","reference_number":"EMA/177209/2013","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-18-21-march-2013_en.pdf"},
    {"id":"34846","name":"Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-13T13:00:00Z","last_updated_date":"2018-09-13T13:02:00Z","reference_number":"EMA/613929/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefprozil-list-nationally-authorised-medicinal-products-psusa00000605201712_en.pdf"},
    {"id":"34848","name":"Overview of comments received on 'Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines' (EMA/CVMP/IWP/314550/2010)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T16:00:00Z","last_updated_date":"2011-11-29T16:00:00Z","reference_number":"EMA/CVMP/IWP/897330/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-design-studies-evaluate-safety-and-efficacy-fish-vaccines-emacvmpiwp3145502010_en.pdf"},
    {"id":"34849","name":"Final assessment report on Crataegus spp., folium cum flore","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/HMPC/159076/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"34850","name":"Zolpidem Article-31 referral - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-04T12:00:00Z","last_updated_date":"2014-08-04T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zolpidem-article-31-referral-cmdh-divergent-position_en.pdf"},
    {"id":"34852","name":"CHMP post-authorisation summary of positive opinion for Abseamed on 23 October 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:00:00Z","last_updated_date":"2008-10-23T02:00:00Z","reference_number":"EMEA/CHMP/567083/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abseamed-23-october-2008_en.pdf"},
    {"id":"34855","name":"Presentation - Procedural update: pre-authorisation procedures (Fia Westerholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-procedural-update-pre-authorisation-procedures-fia-westerholm_en.pdf"},
    {"id":"34856","name":"Recognition criteria for self assessment - Enpr-EMA: European Society of Paediatric Gastroenterology Heptology and Nutrition ((ESPGHAN)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/241053/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-enpr-ema-european-society-paediatric-gastroenterology-heptology-and-nutrition-espghan_en.pdf"},
    {"id":"34858","name":"Scientific requirements for cell therapy and tissue engineered products: Non-clinical and clinical aspects - Giovanni Migliaccio","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-requirements-cell-therapy-and-tissue-engineered-products-non-clinical-and-clinical-aspects-giovanni-migliaccio_en.pdf"},
    {"id":"34860","name":"CVMP monthly report of application procedures, guidelines and related documents: September 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-10-01T12:10:00Z","last_updated_date":"2012-10-01T12:10:00Z","reference_number":"EMA/615951/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-september-2012_en.pdf"},
    {"id":"34861","name":"Presentation - Overview of European Medicines Agency's interaction with patients and consumers during 2015 (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-01T01:00:00Z","last_updated_date":"2016-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-european-medicines-agencys-interaction-patients-and-consumers-during-2015-nathalie-bere_en.pdf"},
    {"id":"34862","name":"EU/3/18/1978: Public summary of opinion on orphan designation: Flucytosine for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-10T02:00:00Z","last_updated_date":"2018-04-10T02:00:00Z","reference_number":"EMA/64659/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181978-public-summary-opinion-orphan-designation-flucytosine-treatment-glioma_en.pdf"},
    {"id":"34863","name":"EU/3/10/799: Public summary of opinion on orphan designation: Tecovirimat for the treatment of cowpox infection","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2012-05-04T14:00:00Z","reference_number":"EMA/COMP/486458/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310799-public-summary-opinion-orphan-designation-tecovirimat-treatment-cowpox-infection_en.pdf"},
    {"id":"34864","name":"Final Community herbal monograph on Plantago ovata Forssk., seminis tegumentum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T16:00:00Z","last_updated_date":"2013-07-23T16:00:00Z","reference_number":"EMA/HMPC/199774/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-plantago-ovata-forssk-seminis-tegumentum_en.pdf"},
    {"id":"34865","name":"EU/3/01/027: Public summary of positive opinion for orphan designation of ibuprofen for the prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/161/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301027-public-summary-positive-opinion-orphan-designation-ibuprofen-prevention-patent-ductus-arteriosus-premature-neonates-less-34-weeks-gestational-age_en.pdf"},
    {"id":"34866","name":"Tysabri Article-20 procedure - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T12:00:00Z","last_updated_date":"2016-03-17T12:00:00Z","reference_number":"EMA/PRAC/171485/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/tysabri-article-20-procedure-assessment-report_en.pdf"},
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    {"id":"34913","name":"Workshop - Deficiency Points - Malcolm Dash","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/workshop-deficiency-points-malcolm-dash_en.pdf"},
    {"id":"34916","name":"EU/3/14/1353: Public summary of opinion on orphan designation: Mexiletine hydrochloride for the treatment of myotonic disorders","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"EMA/COMP/660449/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141353-public-summary-opinion-orphan-designation-mexiletine-hydrochloride-treatment-myotonic-disorders_en.pdf"},
    {"id":"34917","name":"Overview of comments received on draft guideline on the procedure to be followed when a batch is suspectedtobe contaminated with Bovine Viral Diarrhoea (BVD) virus","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-03-17T01:00:00Z","last_updated_date":"2008-03-17T01:00:00Z","reference_number":"EMEA/123421/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-procedure-be-followed-when-batch-suspectedtobe-contaminated-bovine-viral-diarrhoea-bvd-virus_en.pdf"},
    {"id":"34919","name":"Presentation - Regulatory Perspective on Real World Evidence (RWE) in scientific advice - EMA's PCWP and HCPWP joint meeting (Jane Moseley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-perspective-real-world-evidence-rwe-scientific-advice-emas-pcwp-and-hcpwp-joint-meeting-jane-moseley_en.pdf"},
    {"id":"34921","name":"Guidelines and concept papers adopted during the CHMP meeting 18-21 July 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T16:00:00Z","last_updated_date":"2016-07-27T16:00:00Z","reference_number":"EMA/76611/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-18-21-july-2016_en.pdf"},
    {"id":"34922","name":"Presentation - The Accelerated Development of Vaccine benefit-risk Collaboration in Europe (ADVANCE) (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accelerated-development-vaccine-benefit-risk-collaboration-europe-advance-xavier-kurz_en.pdf"},
    {"id":"34927","name":"Guideline on assessing the risk for virus transmission - new chapter 6 of the note for guidance on plasma derived medicinal products (CPMP/BWP/269/95)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-04-30T02:00:00Z","last_updated_date":"2005-04-30T02:00:00Z","reference_number":"CPMP/BWP/5180/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-assessing-risk-virus-transmission-new-chapter-6-note-guidance-plasma-derived-medicinal-products-cpmpbwp26995_en.pdf"},
    {"id":"34929","name":"EU/3/14/1268: Public summary of opinion on orphan designation: Humanised monoclonal antibody against CD38 for the treatment of plasma cell myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-06-04T02:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMA/COMP/171715/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141268-public-summary-opinion-orphan-designation-humanised-monoclonal-antibody-against-cd38-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"34930","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-09-19T18:23:00Z","last_updated_date":"2016-09-19T18:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-september-2016_en.pdf"},
    {"id":"34934","name":"Note for guidance on clinical investigation of medicinal products in the treatment of cardiac failure - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-12-16T01:00:00Z","last_updated_date":"1999-12-16T01:00:00Z","reference_number":"CPMP/EWP/235/95, Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-medicinal-products-treatment-cardiac-failure-revision-1_en.pdf"},
    {"id":"34935","name":"Testosterone Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-08T01:00:00Z","last_updated_date":"2015-01-08T01:00:00Z","reference_number":"EMEA/H/A-31/1396","document_url":"https://www.ema.europa.eu/en/documents/referral/testosterone-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/testosterone-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/testosterone-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/testosterone-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/testosterone-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/testosterone-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/testosterone-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/testosterone-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/testosterone-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/testosterone-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/testosterone-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/testosterone-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/testosterone-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/testosterone-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/testosterone-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/testosterone-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/testosterone-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/testosterone-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/testosterone-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/testosterone-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/testosterone-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/testosterone-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/testosterone-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"34937","name":"Human von willebrand factor: List of nationally authorised medicinal products - PSUSA/00001642/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T15:00:00Z","last_updated_date":"2018-05-23T15:05:14Z","reference_number":"EMA/307511/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-von-willebrand-factor-list-nationally-authorised-medicinal-products-psusa00001642201709_en.pdf"},
    {"id":"34938","name":"Overview of comments received on 'Questions and answers on the ‘Note for guidance of photosafety testing’'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-04-11T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMA/CHMP/SWP/170012/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-questions-and-answers-note-guidance-photosafety-testing_en.pdf"},
    {"id":"34940","name":"Draft community herbal monograph on Pimpinella anisum L., aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-09-15T02:09:21Z","last_updated_date":"2006-09-15T02:09:21Z","reference_number":"EMEA/HMPC/263273/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-pimpinella-anisum-l-aetheroleum_en.pdf"},
    {"id":"34941","name":"Presentation - SCOPE activities report (J. Raine)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/presentation-scope-activities-report-j-raine_en.pdf"},
    {"id":"34942","name":"CVMP monthly report of application procedures, guidelines and related documents: November 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-12-10T15:51:00Z","last_updated_date":"2013-12-10T15:51:00Z","reference_number":"EMA/736920/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cvmp-monthly-report-application-procedures-guidelines-and-related-documents-november-2013_en.pdf"},
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    {"id":"34947","name":"Procedure for the nomination and appointment of co-opted members of the Medicinal Products for Human Use (CHMP), the Committee for Veterinary Medicinal Products (CVMP) and the Committee on Herbal Medicinal Products (HMPC) (effective from 02/05/2022)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-03-01T01:00:00Z","last_updated_date":"2022-04-28T09:37:00Z","reference_number":"EMA/747064/2021 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-nomination-and-appointment-co-opted-members-medicinal-products-human-use-chmp-committee-veterinary-medicinal-products-cvmp-and-committee-herbal-medicinal-products-hmpc-effective-02052022_en.pdf"},
    {"id":"34948","name":"Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-12T18:00:00Z","last_updated_date":"2014-03-12T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/monovalent-and-multivalent-measles-mumps-rubella-and-or-varicella-vaccines-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"34950","name":"Opinion of the CVMP on the establishment of maximum residue limits: Phoxim","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-01-22T10:10:00Z","last_updated_date":"2013-01-22T10:10:00Z","reference_number":"EMA/CVMP/78444/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-phoxim_en.pdf"},
    {"id":"34951","name":"Amoxil Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-09-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/amoxil-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/amoxil-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/amoxil-article-30-referral-annex-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/amoxil-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/amoxil-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/amoxil-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/amoxil-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/amoxil-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/amoxil-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/amoxil-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/amoxil-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/amoxil-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/amoxil-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/amoxil-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/amoxil-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/amoxil-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/amoxil-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/amoxil-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/amoxil-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/amoxil-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/amoxil-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/amoxil-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/amoxil-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/amoxil-article-30-referral-annex-iii_no.pdf"}},
    {"id":"34954","name":"Presentation - The latest advances in the understanding of the pathophysiology of Alzheimer’s disease and the development of disease-modifying therapies (Gary Romano)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-latest-advances-understanding-pathophysiology-alzheimers-disease-and-development-disease-modifying-therapies-gary-romano_en.pdf"},
    {"id":"34955","name":"CVMP post-authorisation summary of positive opinion for SevoFlo","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-10-06T02:00:00Z","last_updated_date":"2017-10-06T02:00:00Z","reference_number":"EMA/CVMP/628411/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-sevoflo_en.pdf"},
    {"id":"34956","name":"Committee for medicinal products for veterinary use summary of opinion: Startvac: International Non-proprietary Names (INN): Inactivated vaccine for cattle","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-12-12T01:09:21Z","last_updated_date":"2008-12-12T01:09:21Z","reference_number":"EMEA/586213/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-startvac-international-non-proprietary-names-inn-inactivated-vaccine-cattle_en.pdf"},
    {"id":"34957","name":"Superseded list of references supporting the assessment report on: Althaeae radix Althaea officinalis L., radix (marshmallow root)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2016-11-04T14:42:00Z","reference_number":"EMEA/HMPC/98716/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-althaeae-radix-althaea-officinalis-l-radix-marshmallow-root_en.pdf"},
    {"id":"34958","name":"EMA Management Board: highlights of December 2015 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/855276/2015 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-december-2015-meeting_en.pdf"},
    {"id":"34961","name":"Levocetirizine: List of nationally authorised medicinal products - PSUSA/00001850/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T13:55:00Z","last_updated_date":"2018-04-27T13:55:00Z","reference_number":"EMA/266150/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/levocetirizine-list-nationally-authorised-medicinal-products-psusa00001850201707_en.pdf"},
    {"id":"34963","name":"EU/3/11/878: Public summary of opinion on orphan designation: Allogeneic T cells encoding an exogenous TK gene for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2011-07-12T02:00:00Z","reference_number":"EMA/COMP/291801/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311878-public-summary-opinion-orphan-designation-allogeneic-t-cells-encoding-exogenous-tk-gene-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"34964","name":"Cefalexin: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/627/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cefalexin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"34968","name":"Presentation - A randomized, double-blind trial of anti-TNF chimeric monoclonal antibody (Infliximab) in combination with methotrexate for the treatment of patients with polyarticular juvenile rheumatoid arthritis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-randomized-double-blind-trial-anti-tnf-chimeric-monoclonal-antibody-infliximab-combination-methotrexate-treatment-patients-polyarticular-juvenile-rheumatoid-arthritis_en.pdf"},
    {"id":"34969","name":"Agenda: Expert meeting in familial neurodegenerative disorders","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-11-05T01:00:00Z","last_updated_date":"2010-11-05T01:00:00Z","reference_number":"EMA/696330/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-expert-meeting-familial-neurodegenerative-disorders_en.pdf"},
    {"id":"34971","name":"Introductory remarks - Use of Fluoroquinolones in Europe - Gerard Moulin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-12T02:09:21Z","last_updated_date":"2006-10-12T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introductory-remarks-use-fluoroquinolones-europe-gerard-moulin_en.pdf"},
    {"id":"34972","name":"Presentation - Croatia - Decision-making phasing-in (Tony Humphreys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-croatia-decision-making-phasing-tony-humphreys_en.pdf"},
    {"id":"34973","name":"COMP meeting report on the review of applications for orphan designation: 3-5 October 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-10-16T13:55:00Z","last_updated_date":"2017-10-16T13:55:00Z","reference_number":"EMA/COMP/634206/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-3-5-october-2017_en.pdf"},
    {"id":"34974","name":"CVMP post-authorisation summary of positive opinion for Novem","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-09T16:30:00Z","last_updated_date":"2012-11-09T16:30:00Z","reference_number":"EMA/CVMP/722500/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-novem_en.pdf"},
    {"id":"34975","name":"Superseded opinion of the HMPC on a Community herbal monograph on Rheum palmatum L. and Rheum officinale Baillon, radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2007-10-31T00:09:00Z","last_updated_date":"2020-08-18T00:09:00Z","reference_number":"EMEA/HMPC/494334/2007EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-rheum-palmatum-l-and-rheum-officinale-baillon-radix_en.pdf"},
    {"id":"34979","name":"Data protection statement for the public consultation on European Medicines Agency policy on access to documents","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-03-15T13:25:00Z","last_updated_date":"2017-03-15T13:25:00Z","reference_number":"EMA/108062/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-protection-statement-public-consultation-european-medicines-agency-policy-access-documents_en.pdf"},
    {"id":"34980","name":"Evaluation of conflicts of interests form (in relation to specific European Medicines Agency activity)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2006-09-25T02:09:21Z","last_updated_date":"2011-07-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/evaluation-conflicts-interests-form-relation-specific-european-medicines-agency-activity_en.pdf"},
    {"id":"34983","name":"Presentation - Assessment of a MAA: Awareness of the PIP recommendation: Generic applications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-assessment-maa-awareness-pip-recommendation-generic-applications_en.pdf-0"},
    {"id":"34984","name":"EU/3/13/1211: Public summary of opinion on orphan designation: Allogeneic and autologous haptenised and irradiated cells and cell lysates derived from glioma for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-22T01:00:00Z","last_updated_date":"2014-01-22T01:00:00Z","reference_number":"EMA/COMP/704856/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131211-public-summary-opinion-orphan-designation-allogeneic-and-autologous-haptenised-and-irradiated-cells-and-cell-lysates-derived-glioma-treatment-glioma_en.pdf"},
    {"id":"34985","name":"Overview of comments received on European Union herbal monograph Prunus africana (Hook f.) Kalkm., cortex (EMA/HMPC/680626/2013)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2017-09-01T02:00:00Z","last_updated_date":"2017-09-01T02:00:00Z","reference_number":"EMA/HMPC/246260/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-prunus-africana-hook-f-kalkm-cortex-emahmpc6806262013_en.pdf"},
    {"id":"34986","name":"Overview of comments received on draft guideline on clinical investigation of immunosupressants for solid organ transplantation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-16T02:00:00Z","last_updated_date":"2008-07-16T02:00:00Z","reference_number":"EMEA/377225/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-clinical-investigation-immunosupressants-solid-organ-transplantation_en.pdf"},
    {"id":"34988","name":"Presentation - \n\nConsiderations for the development of biological medicinal products (Camilla Svensson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T18:12:00Z","last_updated_date":"2016-10-26T18:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-considerations-development-biological-medicinal-products-camilla-svensson_en.pdf"},
    {"id":"34989","name":"EU/3/10/791: Public summary of opinion on orphan designation: Ciclosporin for the treatment of moderate and severe closed traumatic brain injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2013-03-19T13:30:00Z","reference_number":"EMA/COMP/479449/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310791-public-summary-opinion-orphan-designation-ciclosporin-treatment-moderate-and-severe-closed-traumatic-brain-injury_en.pdf"},
    {"id":"34991","name":"CHMP summary of positive opinion for Imfinzi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2018-07-27T14:00:00Z","reference_number":"EMA/CHMP/458931/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imfinzi_en.pdf"},
    {"id":"34992","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the January 2009 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-01-08T00:09:21Z","last_updated_date":"2009-01-08T00:09:21Z","reference_number":"EMEA/COMP/694107/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-january-2009-meeting_en.pdf"},
    {"id":"34993","name":"Presentation - Peptides, cell therapy (Thomas Hinz) - S4.3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-peptides-cell-therapy-thomas-hinz-s43_en.pdf"},
    {"id":"34999","name":"Guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-21T11:30:00Z","last_updated_date":"2012-06-21T11:30:00Z","reference_number":"EMA/CHMP/BPWP/1619/1999 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-human-plasma-derived-and-recombinant-coagulation-factor-viii-products-revision-1_en.pdf"},
    {"id":"35002","name":"Presentation - Case study 2 - Avelumab integrated Mab example - Session 5 (Isabelle Colmagne-Poulard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-2-avelumab-integrated-mab-example-session-5-isabelle-colmagne-poulard_en.pdf"},
    {"id":"35003","name":"Minutes of the fifth meeting of the EMEA Human Scientific Committees’ Working Party with with Patients’ and Consumers’ Organisations (PCWP)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2008-06-30T02:00:00Z","last_updated_date":"2008-06-30T02:00:00Z","reference_number":"EMEA/122940/2008","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-fifth-meeting-emea-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp_en.pdf"},
    {"id":"35005","name":"EU/3/12/1078 : Public summary of opinion on orphan designation: Exon-55-specific phosphorothioate oligonucleotide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-01-25T12:00:00Z","last_updated_date":"2013-01-25T12:00:00Z","reference_number":"EMA/COMP/740569/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121078-public-summary-opinion-orphan-designation-exon-55-specific-phosphorothioate-oligonucleotide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"35007","name":"CHMP post-authorisation summary of positive opinion for Arzerra","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/CHMP/312178/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-arzerra_en.pdf-0"},
    {"id":"35009","name":"Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Zavesca","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2007-10-18T02:09:21Z","last_updated_date":"2007-10-18T02:09:21Z","reference_number":"EMEA/461135/2007","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-zavesca_en.pdf"},
    {"id":"35011","name":"Technical specification - Annex 12b - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-01-03T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-12b-external-service-providers-software-applications-ema201213ict_en.xls"},
    {"id":"35014","name":"Minutes of the second 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T12:45:00Z","last_updated_date":"2017-07-24T12:45:00Z","reference_number":"EMA/329838/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-second-2017-meeting-coordinating-group-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"35015","name":"Policresulen (metacresol sulphonic acid-formaldehyde): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/035/095","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/policresulen-metacresol-sulphonic-acid-formaldehyde-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35016","name":"Draft assessment report on Pistacia lentiscus L., resin (mastic)","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-07-22T11:30:00Z","last_updated_date":"2015-07-22T11:30:00Z","reference_number":"EMA/HMPC/46756/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-pistacia-lentiscus-l-resin-mastic_en.pdf"},
    {"id":"35017","name":"Presentation - Innovation Task Force (Marisa Papaluca)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-innovation-task-force-marisa-papaluca_en.pdf"},
    {"id":"35019","name":"Cydectin TriclaMox: Article-13 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-10-18T13:00:00Z","last_updated_date":"2013-10-18T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cydectin-triclamox-article-13-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"35020","name":"PRAC meetings in 2019, 2020, 2021","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-02-26T14:00:00Z","last_updated_date":"2019-12-03T17:10:00Z","reference_number":"EMA/PRAC/92423/2018 Corr.4","document_url":"https://www.ema.europa.eu/en/documents/other/prac-meetings-2019-2020-2021_en.pdf"},
    {"id":"35021","name":"Opinion following an Article 29(2) referral for Lansoprazol AbZ-Pharma 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-02-22T00:08:21Z","last_updated_date":"2006-02-22T00:08:21Z","reference_number":"EMEA/CHMP/373083/2005","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-292-referral-lansoprazol-abz-pharma-15-mg-and-30-mg-international-non-proprietary-name-inn-lansoprazole-background-information_sv.pdf"}},
    {"id":"35024","name":"EU/3/14/1336: Public summary of opinion on orphan designation: (S)-6-Hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for the treatment of Leigh syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/557459/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141336-public-summary-opinion-orphan-designation-s-6-hydroxy-2578-tetramethyl-n-r-piperidin-3-ylchroman-2-carboxamide-hydrochloride-treatment-leigh-syndrome_en.pdf"},
    {"id":"35025","name":"Agenda for the 97th meeting of the Management Board","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-10-03T10:45:00Z","last_updated_date":"2017-10-05T13:00:00Z","reference_number":"EMA/MB/158073/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-97th-meeting-management-board_en.pdf"},
    {"id":"35026","name":"Concept paper on a guideline on the assessment of pharmacological/pharmacodynamic data to establish a pharmacological ADI draft","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2005-05-18T02:00:00Z","last_updated_date":"2005-05-18T02:00:00Z","reference_number":"EMEA/CVMP/SWP/122154/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-assessment-pharmacologicalpharmacodynamic-data-establish-pharmacological-adi-draft_en.pdf"},
    {"id":"35027","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-02-18T01:00:00Z","last_updated_date":"2011-02-18T01:00:00Z","reference_number":"CHMP post-authorisation summary of positive opinio","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-6"},
    {"id":"35030","name":"Presentation - Multi-arm trials with repurposed drugs in progressive MS (Jeremy Chataway)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-arm-trials-repurposed-drugs-progressive-ms-jeremy-chataway_en.pdf"},
    {"id":"35031","name":"Draft community herbal monograph on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2007-07-05T02:09:21Z","reference_number":"EMEA/HMPC/244569/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
    {"id":"35032","name":"CHMP summary of positive opinion for Darunavir Krka d.d.","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2023-02-03T01:00:00Z","reference_number":"EMA/CHMP/729969/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-darunavir-krka-dd_en.pdf"},
    {"id":"35033","name":"Submission of comments on good pharmacovigilance practices: Module VIII – Post-authorisation safety studies (EMA/813938/2011)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-22T13:20:00Z","last_updated_date":"2012-02-22T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-good-pharmacovigilance-practices-module-viii-post-authorisation-safety-studies-ema8139382011_en.doc"},
    {"id":"35036","name":"Quality assessors training - Diana van Riet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/quality-assessors-training-diana-van-riet_en.pdf"},
    {"id":"35038","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-05-08T12:59:00Z","last_updated_date":"2017-05-08T12:59:00Z","reference_number":"EMA/CAT/251488/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2017_en.pdf"},
    {"id":"35039","name":"Overview of comments received on 'CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced-therapy medicinal products'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-06-28T02:00:00Z","last_updated_date":"2011-06-28T02:00:00Z","reference_number":"EMA/CHMP/BWP/782739/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-chmpcat-position-statement-creutzfeldt-jakob-disease-and-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"35042","name":"Committee for Proprietary Medicinal Products (CPMP) 47th plenary meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1999-03-29T02:00:00Z","last_updated_date":"1999-03-29T02:00:00Z","reference_number":"CPMP/841/99","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-47th-plenary-meeting_en.pdf"},
    {"id":"35044","name":"Statement of expenses for candidate reimbursement","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-08-10T15:09:00Z","last_updated_date":"2018-08-10T15:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/statement-expenses-candidate-reimbursement_en.xlsm"},
    {"id":"35045","name":"Draft assessment report on Syzygium aromaticum (L.) Merill et L.M. Perry, flos and Syzygium aromaticum (L.) Merill et L.M. Perry, floris aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-03-28T02:00:00Z","last_updated_date":"2011-03-28T02:00:00Z","reference_number":"EMA/HMPC/534946/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-syzygium-aromaticum-l-merill-et-lm-perry-flos-and-syzygium-aromaticum-l-merill-et-lm-perry-floris-aetheroleum_en.pdf"},
    {"id":"35048","name":"Concept paper on the development of a guideline on live recombinant vector vaccines","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-07-16T02:00:00Z","last_updated_date":"2007-07-16T02:00:00Z","reference_number":"EMEA/CHMP/308139/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-live-recombinant-vector-vaccines_en.pdf"},
    {"id":"35049","name":"EU/3/14/1282: Public summary of opinion on orphan designation: Mixture of two adeno-associated viral vectors serotype 8 containing the 5’-half sequence of human MYO7A gene and the 3’-half sequence of human MYO7A gene for...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-16T02:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMA/COMP/319754/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141282-public-summary-opinion-orphan-designation-mixture-two-adeno-associated-viral-vectors-serotype-8-containing-5-half-sequence-human-myo7a-gene-and-3-half-sequence-human-myo7a-gene_en.pdf"},
    {"id":"35050","name":"Overview of comments received on 'Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-09-27T13:10:00Z","last_updated_date":"2017-09-27T13:10:00Z","reference_number":"EMA/CHMP/853503/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-strategies-identify-and-mitigate-risks-first-human-and-early-clinical-trials-investigational-medicinal-products_en.pdf"},
    {"id":"35051","name":"Superseded Community herbal monograph on Vitex agnus-castus L., fructus - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-08-05T02:00:00Z","last_updated_date":"2018-10-10T02:00:00Z","reference_number":"EMA/HMPC/144006/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-vitex-agnus-castus-l-fructus-first-version_en.pdf"},
    {"id":"35053","name":"European Medicines Agency tightens rules on 'revolving door' for committee members and experts","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-06T12:00:00Z","last_updated_date":"2015-05-06T12:00:00Z","reference_number":"EMA/282052/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-tightens-rules-revolving-door-committee-members-and-experts_en.pdf"},
    {"id":"35055","name":"EU/3/05/286: Public summary of positive opinion for orphan designation of N-(methyl-diazacyclohexyl-methylbenzamide)-azaphenyl-aminothiopyrrole for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-07-26T02:00:00Z","last_updated_date":"2005-07-26T02:00:00Z","reference_number":"EMEA/COMP/163647/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305286-public-summary-positive-opinion-orphan-designation-n-methyl-diazacyclohexyl-methylbenzamide-azaphenyl-aminothiopyrrole-treatment-multiple-myeloma_en.pdf"},
    {"id":"35058","name":"CHMP meeting dates 2016, 2017 and 2018","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-09T01:00:00Z","last_updated_date":"2016-02-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2016-2017-and-2018_en.pdf"},
    {"id":"35059","name":"Mandate, objectives and rules of procedure for the Excipients Drafting Group","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2016-03-16T01:00:00Z","last_updated_date":"2016-03-16T01:00:00Z","reference_number":"EMA/CHMP/74184/2015","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-excipients-drafting-group_en.pdf"},
    {"id":"35061","name":"Welcome speech - Sinisa Tomic, ALMP, Croatia","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-12-09T00:09:00Z","last_updated_date":"2008-12-09T00:09:00Z","reference_number":"EMEA/662143/2008","document_url":"https://www.ema.europa.eu/en/documents/other/welcome-speech-sinisa-tomic-almp-croatia_en.pdf"},
    {"id":"35064","name":"CHMP summary of positive opinion for Prepandrix","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"EMEA/CHMP/334055/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-prepandrix_en.pdf"},
    {"id":"35066","name":"European Commission - Canada mutual recognition agreement: Sectoral annex on good manufacturing products -  Seventh joint sectoral group meeting, first year of operation of the sectoral annex","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-07-15T02:00:00Z","last_updated_date":"2004-07-15T02:00:00Z","reference_number":"EMEA/INS/MRA/CA/04/04","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-canada-mutual-recognition-agreement-sectoral-annex-good-manufacturing-products-seventh-joint-sectoral-group-meeting-first-year-operation-sectoral-annex_en.pdf"},
    {"id":"35070","name":"Report from scientific workshop on serology assays and correlates of protection for influenza vaccines: 29-30 June 2010","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-12-22T12:02:11Z","last_updated_date":"2010-12-22T12:02:11Z","reference_number":"EMA/732806/2010","document_url":"https://www.ema.europa.eu/en/documents/report/report-scientific-workshop-serology-assays-and-correlates-protection-influenza-vaccines-29-30-june-2010_en.pdf"},
    {"id":"35072","name":"Standard Operating Procedure for Template for recording top management decisions","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2006-03-06T01:00:00Z","last_updated_date":"2006-03-06T01:00:00Z","reference_number":"EMEA/245906/2005","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-template-recording-top-management-decisions_en.pdf"},
    {"id":"35073","name":"European Medicines Agency amends minor-use-minor-species / limited-market policy","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-06-18T18:40:00Z","last_updated_date":"2013-06-18T18:40:00Z","reference_number":"EMA/327514/2013","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-amends-minor-use-minor-species-limited-market-policy_en.pdf"},
    {"id":"35077","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-10-11T14:00:00Z","last_updated_date":"2016-10-11T14:00:00Z","reference_number":"EMA/CHMP/691443/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-7"},
    {"id":"35079","name":"Presentation - Descriptive overview of paediatric versus adult adverse drug reactions in EudraVigilance (Kevin Blake)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-descriptive-overview-paediatric-versus-adult-adverse-drug-reactions-eudravigilance-kevin-blake_en.pdf"},
    {"id":"35080","name":"Draft list of references supporting the assessment of Rubus idaeus L., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/HMPC/44210/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-rubus-idaeus-l-folium_en.pdf"},
    {"id":"35081","name":"Withdrawal letter: Translarna","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-translarna_en.pdf"},
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    {"id":"35086","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: November2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-12-21T11:00:00Z","last_updated_date":"2017-12-21T11:00:00Z","reference_number":"EMA/779051/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-november2017_en.pdf"},
    {"id":"35088","name":"Workshop on stem cell-based therapies: Invitation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-02-16T01:09:21Z","last_updated_date":"2010-02-16T01:09:21Z","reference_number":"EMA/CHMP/CPWP/51422/2010","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-stem-cell-based-therapies-invitation_en.pdf"},
    {"id":"35089","name":"Alkem Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/228190/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/alkem-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"35090","name":"Citri aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/407/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/citri-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35092","name":"Annex I variation application(s) content for live attenuated influenza vaccines","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-08-08T02:00:00Z","last_updated_date":"2011-08-08T02:00:00Z","reference_number":"EMA/CHMP/BWP/577998/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-i-variation-applications-content-live-attenuated-influenza-vaccines_en.pdf-0"},
    {"id":"35096","name":"Joint audit programme for EEA GMP inspectorates: Confidentiality agreement for audits","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-18T02:00:00Z","last_updated_date":"2019-02-22T02:00:00Z","reference_number":"EMA/167084/2018 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-eea-gmp-inspectorates-confidentiality-agreement-audits_en.docx"},
    {"id":"35098","name":"VICH GL56 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods -...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T17:30:00Z","last_updated_date":"2018-07-27T17:30:00Z","reference_number":"EMA/CVMP/VICH/176637/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl56-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-species-study-design-recommendations-residue-studies-honey-establishing-mrls-and-withdrawal-periods_en.pdf"},
    {"id":"35099","name":"Presentation - Enhanced approach (Kowid Ho)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enhanced-approach-kowid-ho_en.pdf"},
    {"id":"35103","name":"Presentation - Non-Placebo and Add on Clinical Trials (Warren W Wasiewski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-placebo-and-add-clinical-trials-warren-w-wasiewski_en.pdf"},
    {"id":"35104","name":"Presentation - Pharmacometric approaches for extrapolation from adult to paediatric type-2 diabetes mellitus (Tarek Leil, Satyendra Suryawanshi, Ronald Portman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacometric-approaches-extrapolation-adult-paediatric-type-2-diabetes-mellitus-tarek-leil-satyendra-suryawanshi-ronald-portman_en.pdf"},
    {"id":"35106","name":"PRAC periodic-safety-update-report assessment report template NAP only","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T16:45:00Z","last_updated_date":"2016-12-19T17:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/prac-periodic-safety-update-report-assessment-report-template-nap-only_en.docx"},
    {"id":"35107","name":"Presentation: Direct patient reporting of adverse drug reactions: a 15-country survey","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-08-20T02:00:00Z","last_updated_date":"2010-08-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-direct-patient-reporting-adverse-drug-reactions-15-country-survey_en.pdf"},
    {"id":"35112","name":"Hydrochloric acid:  European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-21T01:00:00Z","last_updated_date":"2013-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hydrochloric-acid-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"35113","name":"Superseded community herbal monograph on Althaea officinalis L., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2016-11-04T14:47:00Z","reference_number":"EMEA/HMPC/98717/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-althaea-officinalis-l-radix_en.pdf"},
    {"id":"35114","name":"Draft assessment report on Cucurbita pepo L., semen","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/HMPC/136022/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"35115","name":"EU/3/10/733: Public summary of opinion on orphan designation: Glyceryl tri-(4-phenylbutyrate) for the treatment of carbamoyl-phosphate synthase-1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2014-02-07T01:00:00Z","reference_number":"EMA/COMP/110042/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310733-public-summary-opinion-orphan-designation-glyceryl-tri-4-phenylbutyrate-treatment-carbamoyl-phosphate-synthase-1-deficiency_en.pdf"},
    {"id":"35118","name":"Corlentor and Procoralan Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T20:00:00Z","last_updated_date":"2014-05-08T20:00:00Z","reference_number":"EMA/280865/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/corlentor-and-procoralan-article-20-procedure-review-started_en.pdf"},
    {"id":"35119","name":"Joint audit programme for European Economic Area GMP inspectorates: Audit report template","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-08-08T02:00:00Z","last_updated_date":"2022-01-24T15:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joint-audit-programme-european-economic-area-gmp-inspectorates-audit-report-template_en.docx"},
    {"id":"35120","name":"Medicines granted a Community marketing authorisation under the centralised procedure since the Committee for Medicinal Products for Human Use meeting 18-21 July 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T15:45:00Z","last_updated_date":"2011-10-06T15:45:00Z","reference_number":"EMA/788369/2011","document_url":"https://www.ema.europa.eu/en/documents/other/medicines-granted-community-marketing-authorisation-under-centralised-procedure-committee-medicinal-products-human-use-meeting-18-21-july-2011_en.pdf"},
    {"id":"35121","name":"Draft list of references for assessment of: Harpagophyti radix Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne (devil's claw root)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-01-10T01:00:00Z","last_updated_date":"2008-01-10T01:00:00Z","reference_number":"EMEA/HMPC/476255/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-harpagophyti-radix-harpagophytum-procumbens-dc-harpagophytum-zeyheri-decne-devils-claw-root_en.pdf"},
    {"id":"35122","name":"EU/3/16/1803: Public summary of opinion on orphan designation: Metformin for the treatment of progressive myoclonic epilepsy type 2 (Lafora disease)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/741007/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161803-public-summary-opinion-orphan-designation-metformin-treatment-progressive-myoclonic-epilepsy-type-2-lafora-disease_en.pdf"},
    {"id":"35123","name":"Presentation - Physiologically based pharmacokinetic modeling with PK-Sim and MoBi in support of the paediatric investigation plan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-physiologically-based-pharmacokinetic-modeling-pk-sim-and-mobi-support-paediatric-investigation-plan_en.pdf"},
    {"id":"35126","name":"Presentation - Session 3.1: Clinical issues: Is product / indication specific guidance necessary and meaningful?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:46Z","last_updated_date":"2012-06-15T17:10:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-31-clinical-issues-product-indication-specific-guidance-necessary-and-meaningful_en.pdf"},
    {"id":"35129","name":"EU/3/01/077: Public summary of positive opinion for orphan designation of [gly2]-recombinant human glucagon-like peptide for the treatment of short-bowel syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2022-09-09T01:00:00Z","reference_number":"EMA/COMP/247424/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301077-public-summary-positive-opinion-orphan-designation-gly2-recombinant-human-glucagon-peptide-treatment-short-bowel-syndrome_en.pdf"},
    {"id":"35131","name":"Presentation - Questionnaire overview (Janina Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-questionnaire-overview-janina-karres_en.pdf"},
    {"id":"35132","name":"EMA Management Board: highlights of June 2017 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-06-16T15:30:00Z","last_updated_date":"2017-06-16T15:30:00Z","reference_number":"EMA/365003/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-june-2017-meeting_en.pdf"},
    {"id":"35135","name":"EU/3/15/1477: Public summary of positive opinion for orphan designation of Human reovirus type-3 Dearing strain for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-21T14:00:00Z","last_updated_date":"2015-05-21T14:00:00Z","reference_number":"EMA/COMP/212797/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151477-public-summary-positive-opinion-orphan-designation-human-reovirus-type-3-dearing-strain-treatment-pancreatic-cancer_en.pdf"},
    {"id":"35136","name":"CVMP summary of positive opinion for Versican Plus Pi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/CVMP/229790/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-versican-plus-pi_en.pdf"},
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    {"id":"35140","name":"Committee for veterinary medicinal products: 51st meeting","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2000-01-13T12:49:21Z","last_updated_date":"2000-01-13T12:49:21Z","reference_number":"EMEA/CVMP/049/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-51st-meeting_en.pdf"},
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    {"id":"35150","name":"Position statement of the CPMP on oral contraceptives containing desogestrel or gestodene of 17 April 1996","type":"position","status":"Adopted","consultation_date":"","first_published_date":"1996-04-17T02:09:21Z","last_updated_date":"1996-04-17T02:09:21Z","reference_number":"CPMP/374/96","document_url":"https://www.ema.europa.eu/en/documents/position/position-statement-cpmp-oral-contraceptives-containing-desogestrel-or-gestodene-17-april-1996_en.pdf"},
    {"id":"35154","name":"Presentation - Survey on post authorisation procedures: Update on improvement actions (Evdokia Korakianiti, Alberto Ganan Jimenez, Ana Zanoletty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T02:00:00Z","last_updated_date":"2016-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-post-authorisation-procedures-update-improvement-actions-evdokia-korakianiti-alberto-ganan-jimenez-ana-zanoletty_en.pdf"},
    {"id":"35156","name":"Public Statement on Trovan/Trovan IV/Tuirvel/Turvel IV (Trovafloxacin/Alatrofloxacin) - Recommendation to suspend the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"1999-06-15T02:00:00Z","last_updated_date":"1999-06-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-trovantrovan-ivtuirvelturvel-iv-trovafloxacinalatrofloxacin-recommendation-suspend-marketing-authorisation-european-union_en.pdf"},
    {"id":"35157","name":"EU/3/17/1909: Public summary of opinion on orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2 for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/507448/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171909-public-summary-opinion-orphan-designation-salmonella-typhi-ty21a-strain-transfected-plasmid-vector-encoding-human-vascular-endothelial-growth-factor-receptor-2-treatment-glioma_en.pdf"},
    {"id":"35158","name":"Guidelines and concept papers adopted during the CHMP meeting 24-27 June 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-07-08T02:00:00Z","last_updated_date":"2013-07-09T19:30:00Z","reference_number":"EMA/CHMP/240800/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-24-27-june-2013_en.pdf"},
    {"id":"35164","name":"Agenda - EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations - December 2013","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-12-05T17:30:00Z","last_updated_date":"2014-02-07T13:30:00Z","reference_number":"EMA/644851/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations-december-2013_en.pdf"},
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    {"id":"35173","name":"EU/3/15/1571: Public summary of opinion on orphan designation: Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of acute lymphoblastic l...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/COMP/697370/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151571-public-summary-opinion-orphan-designation-autologous-t-cells-transduced-retroviral-vector-encoding-anti-cd19-cd28cd3-zeta-chimeric-antigen-receptor-treatment-acute-lymphoblastic-l_en.pdf"},
    {"id":"35177","name":"Astellas Pharma Europe B.V. withdraws its application for an extension of the indication for Qutenza (capsaicin)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-03-20T10:15:00Z","last_updated_date":"2012-03-20T10:15:00Z","reference_number":"EMA/197157/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/astellas-pharma-europe-bv-withdraws-its-application-extension-indication-qutenza-capsaicin_en.pdf"},
    {"id":"35178","name":"Presentation: Update from EMA Workshop on extrapolation of efficacy in children","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ema-workshop-extrapolation-efficacy-children_en.pdf"},
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    {"id":"35182","name":"Methylphenidate Sandoz Article-29 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-12-05T01:00:00Z","last_updated_date":"2013-12-05T01:00:00Z","reference_number":"EMA/596774/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/methylphenidate-sandoz-article-29-referral-assessment-report_en.pdf"},
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    {"id":"35187","name":"Micro Therapeutic Research Article-31 referral - CHMP list of questions\n\nto be addressed by Micro Therapeutic Research Labs","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"EMA/CHMP/302887/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-chmp-list-questions-be-addressed-micro-therapeutic-research-labs_en.pdf"},
    {"id":"35188","name":"Risk indicators for Shortages (Manufacturing and Quality)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T00:00:00Z","last_updated_date":"2013-01-29T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/risk-indicators-shortages-manufacturing-and-quality_en.pdf"},
    {"id":"35189","name":"CVMP summary of positive opinion for Sevocalm","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/CVMP/213655/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-sevocalm_en.pdf"},
    {"id":"35190","name":"European Medicines Agency recommends restricting use of cilostazol-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-22T11:00:00Z","last_updated_date":"2013-03-22T11:00:00Z","reference_number":"EMA/98571/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_en.pdf"},
    {"id":"35191","name":"Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with Bovine Viral Diarrhoea (BVD) virus","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-03-17T01:00:00Z","last_updated_date":"2008-03-17T01:00:00Z","reference_number":"EMEA/CVMP/IWP/205351/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-procedure-be-followed-when-batch-vaccine-finished-product-suspected-be-contaminated-bovine-viral-diarrhoea-bvd-virus_en.pdf"},
    {"id":"35194","name":"Annex VIII - List of cilostazol-containing medicinal products in the European Union","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2014-05-28T11:15:00Z","last_updated_date":"2017-07-26T13:30:00Z","reference_number":"EMA/294357/2014 correction 2*","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-viii-list-cilostazol-containing-medicinal-products-european-union_en.xls"},
    {"id":"35195","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2013 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T18:10:00Z","last_updated_date":"2013-04-30T18:10:00Z","reference_number":"EMA/CAT/256262/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2013-meeting_en.pdf"},
    {"id":"35196","name":"Draft list of references supporting the assessment of Allium sativum L., bulbus","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2016-07-25T02:00:00Z","last_updated_date":"2016-07-25T02:00:00Z","reference_number":"EMA/HMPC/7687/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-allium-sativum-l-bulbus_en.pdf"},
    {"id":"35201","name":"Multiannual work programme to 2020","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T16:05:00Z","last_updated_date":"2016-06-30T16:05:00Z","reference_number":"EMA/319713/2016","document_url":"https://www.ema.europa.eu/en/documents/work-programme/multiannual-work-programme-2020_en.pdf"},
    {"id":"35204","name":"Minutes of the European Medicines Agency/European Federation of Pharmaceutical Industries and Associations second workshop on adaptive design in confirmatory trials","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2010-03-30T02:00:00Z","last_updated_date":"2010-03-30T02:00:00Z","reference_number":"EMA/779520/2009","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-federation-pharmaceutical-industries-and-associations-second-workshop-adaptive-design-confirmatory-trials_en.pdf"},
    {"id":"35209","name":"Committee for veterinary medicinal products: Meeting of 10 to 12 February 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-02-13T12:49:21Z","last_updated_date":"2004-02-13T12:49:21Z","reference_number":"EMEA/CVMP/213/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-10-12-february-2004_en.pdf"},
    {"id":"35212","name":"Epirubicin: List of nationally authorised medicinal products - PSUSA/00001234/201706","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-27T11:50:00Z","last_updated_date":"2018-03-27T11:52:12Z","reference_number":"EMA/191568/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/epirubicin-list-nationally-authorised-medicinal-products-psusa00001234201706_en.pdf"},
    {"id":"35213","name":"Explanatory note for clarification of the scope of the VICH guideline 17 on 'Stability testing of new biotechnological/biological veterinary medicinal products CVMP/VICH/501/99'","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-06-18T02:00:00Z","last_updated_date":"2008-06-18T02:00:00Z","reference_number":"EMEA/CVMP/IWP/319771/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/explanatory-note-clarification-scope-vich-guideline-17-stability-testing-new-biotechnologicalbiological-veterinary-medicinal-products-cvmpvich50199_en.pdf"},
    {"id":"35214","name":"PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T13:00:00Z","last_updated_date":"2016-12-02T13:00:00Z","reference_number":"EMA/795452/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-warns-risk-hepatitis-b-re-activation-direct-acting-antivirals-hepatitis-c_en.pdf"},
    {"id":"35217","name":"Neomycin (including framycetin) (all food producing species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-11-12T12:33:00Z","last_updated_date":"2013-11-12T12:33:00Z","reference_number":"EMA/CVMP/561830/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/neomycin-including-framycetin-all-food-producing-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"35219","name":"Draft list of references for assessment of: Urticae herba Urtica dioica L.; Urtica urens L., herba (nettle herb)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-09-07T02:00:00Z","last_updated_date":"2007-09-07T02:00:00Z","reference_number":"EMEA/HMPC/366106/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-urticae-herba-urtica-dioica-l-urtica-urens-l-herba-nettle-herb_en.pdf"},
    {"id":"35220","name":"SGLT2 inhibitors Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-12T14:00:00Z","last_updated_date":"2015-06-12T14:00:00Z","reference_number":"EMA/PRAC/390892/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"35221","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-01-18T13:00:00Z","last_updated_date":"2013-01-18T13:00:00Z","reference_number":"EMA/CHMP/30243/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-8"},
    {"id":"35223","name":"EU/3/13/1164: Public summary of opinion on orphan designation: Heterologous human adult liver-derived progenitor cells for the treatment of hyperargininaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2013-08-21T14:30:00Z","reference_number":"EMA/COMP/413217/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131164-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-progenitor-cells-treatment-hyperargininaemia_en.pdf"},
    {"id":"35225","name":"European Medicines Agency introduces new, faster scientific advice procedure","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-05-31T02:00:00Z","last_updated_date":"2009-05-31T02:00:00Z","reference_number":"EMEA/165974/2006 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-introduces-new-faster-scientific-advice-procedure_en.pdf"},
    {"id":"35228","name":"Review of the manufacture of Baxter’s peritoneal dialysis solutions initiated over potential presence of endotoxins in some batches","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-01-21T01:00:00Z","last_updated_date":"2011-01-21T01:00:00Z","reference_number":"EMA/52545/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/review-manufacture-baxters-peritoneal-dialysis-solutions-initiated-over-potential-presence-endotoxins-some-batches_en.pdf"},
    {"id":"35232","name":"Diclofenac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001048/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T14:00:00Z","last_updated_date":"2016-10-17T20:37:51Z","reference_number":"EMA/475009/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/diclofenac-systemic-formulations-list-nationally-authorised-medicinal-products-psusa00001048201509_en.pdf"},
    {"id":"35234","name":"Start of Community reviews","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-11-22T13:00:00Z","last_updated_date":"2013-11-22T13:00:00Z","reference_number":"EMA/711468/2013","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews_en.pdf"},
    {"id":"35235","name":"Draft assessment report on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria (L.)), herba and Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria (L.)), flos - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-01-26T01:00:00Z","last_updated_date":"2011-01-26T01:00:00Z","reference_number":"EMA/HMPC/434892/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-filipendula-ulmaria-l-maxim-spiraea-ulmaria-l-herba-and-filipendula-ulmaria-l-maxim-spiraea-ulmaria-l-flos-first-version_en.pdf"},
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    {"id":"35295","name":"Committee for Medicinal Products for Veterinary Use and Committee for Medicinal Products for Human Use: Presence of the antibiotic resistance marker gene nptII in genetically modified plants for food and feed uses","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-02-22T00:09:21Z","last_updated_date":"2007-02-22T00:09:21Z","reference_number":"EMEA/CVMP/56937/2007- Final","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-and-committee-medicinal-products-human-use-presence-antibiotic-resistance-marker-gene-nptii-genetically-modified-plants-food-and-feed-uses_en.pdf"},
    {"id":"35296","name":"Questions and answers on veterinary medicinal products containing altrenogest to be administered orally to pigs and horses","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-09-08T02:00:00Z","last_updated_date":"2016-09-08T02:00:00Z","reference_number":"EMA/462829/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-veterinary-medicinal-products-containing-altrenogest-be-administered-orally-pigs-and-horses_en.pdf"},
    {"id":"35297","name":"Hydrocortisone: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-03-01T01:00:00Z","last_updated_date":"1998-03-01T01:00:00Z","reference_number":"EMEA/MRL/377/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hydrocortisone-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35298","name":"Presentation - Support available to SMEs nationally and internationally – FDA, Ms Brenda Stodart","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-support-available-smes-nationally-and-internationally-fda-ms-brenda-stodart_en.pdf"},
    {"id":"35299","name":"Presentation - Follow-up from the EC/EMA workshop on paediatrics (Ralph Bax)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:31:00Z","last_updated_date":"2018-06-06T17:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-follow-ecema-workshop-paediatrics-ralph-bax_en.pdf"},
    {"id":"35301","name":"CHMP summary of positive opinion for Ribavirin Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-01-21T01:00:00Z","last_updated_date":"2021-07-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ribavirin-teva_en.pdf"},
    {"id":"35304","name":"Valproate Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T13:00:00Z","last_updated_date":"2017-04-11T20:00:00Z","reference_number":"EMEA/H/A-31/1454","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-annex-i_en.pdf-0"},
    {"id":"35305","name":"EU/3/11/896: Public summary of opinion on orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol f...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-09-21T02:00:00Z","last_updated_date":"2022-04-06T02:00:00Z","reference_number":"EMA/COMP/512931/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311896-public-summary-opinion-orphan-designation-multilamellar-microvesicle-comprising-phosphatidylcholine-sphingomyelin-phosphatidylethanolamine-phosphatidylserine-phosphatidylinositol-and_en.pdf"},
    {"id":"35308","name":"Final European Union herbal monograph on Crataegus spp., folium cum flore","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/HMPC/159075/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-crataegus-spp-folium-cum-flore_en.pdf"},
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    {"id":"35312","name":"Superseded opinion of the HMPC on a Community herbal monograph on Pelargonium sidoides DC and / or Pelargonium reniforme Curt., radix - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-02-04T12:30:00Z","last_updated_date":"2018-08-20T13:30:00Z","reference_number":"EMA/HMPC/742263/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-pelargonium-sidoides-dc-and-or-pelargonium-reniforme-curt-radix-first-version_en.pdf"},
    {"id":"35317","name":"EU/3/13/1163: Public summary of opinion on orphan designation: Heterologous human adult liver-derived progenitor cells for the treatment of argininosuccinic aciduria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2013-08-21T14:30:00Z","reference_number":"EMA/COMP/413216/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131163-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-progenitor-cells-treatment-argininosuccinic-aciduria_en.pdf"},
    {"id":"35318","name":"Doxyfar 50% - Article 34 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-08-23T02:00:00Z","last_updated_date":"2011-08-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/doxyfar-50-article-34-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"35319","name":"Draft reflection paper on data requirements for swine influenza vaccines against pandemic (H1N1) 2009 influenza","type":"scientific-guideline","status":"Draft","consultation_date":"","first_published_date":"2010-02-17T00:09:21Z","last_updated_date":"2010-02-17T00:09:21Z","reference_number":"EMA/CVMP/IWP/58879/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-data-requirements-swine-influenza-vaccines-against-pandemic-h1n1-2009-influenza_en.pdf"},
    {"id":"35320","name":"EU/3/15/1465: Public summary of positive opinion for orphan designation of ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a LAMB3-encoding retroviral vector for the treatm...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/116169/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151465-public-summary-positive-opinion-orphan-designation-ex-vivo-expanded-autologous-human-keratinocytes-containing-epidermal-stem-cells-transduced-lamb3-encoding-retroviral-vector-treatm_en.pdf"},
    {"id":"35321","name":"Calcium glucoheptonate, calcium glucono glucoheptonate, calcium gluconolactate, calcium glutamate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/350/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/calcium-glucoheptonate-calcium-glucono-glucoheptonate-calcium-gluconolactate-calcium-glutamate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35325","name":"EU/3/10/823: Public summary of opinion on orphan designation: Lomitapide for the treatment of familial chylomicronaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMA/COMP/639953/2010 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310823-public-summary-opinion-orphan-designation-lomitapide-treatment-familial-chylomicronaemia_en.pdf"},
    {"id":"35326","name":"Orion Corporation withdraws its application for an extension of indication for Stalevo (levodopa/carbidopa/entacapone)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-10T01:00:00Z","last_updated_date":"2009-03-10T01:00:00Z","reference_number":"EMEA/147137/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/orion-corporation-withdraws-its-application-extension-indication-stalevo-levodopacarbidopaentacapone_en.pdf"},
    {"id":"35327","name":"Qualification opinion on ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-02-15T16:40:00Z","last_updated_date":"2016-02-15T16:40:00Z","reference_number":"EMA/CHMP/SAWP/513571/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-ingestible-sensor-system-medication-adherence-biomarker-measuring-patient-adherence-medication-clinical-trials_en.pdf"},
    {"id":"35329","name":"Final Community herbal monograph on Echinacea angustifolia DC., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-05-29T16:30:00Z","last_updated_date":"2012-05-29T16:30:00Z","reference_number":"EMA/HMPC/688216/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-echinacea-angustifolia-dc-radix_en.pdf"},
    {"id":"35332","name":"Overview of comments received on list of paediatric needs - Epilepsy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-09-21T02:00:00Z","last_updated_date":"2006-09-21T02:00:00Z","reference_number":"EMEA/377231/2006","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-list-paediatric-needs-epilepsy_en.pdf"},
    {"id":"35333","name":"CHMP post-authorisation summary of positive opinion for Xalkori","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T14:00:00Z","last_updated_date":"2015-10-23T14:00:00Z","reference_number":"EMA/CHMP/489271/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xalkori_en.pdf-0"},
    {"id":"35336","name":"Standard operating procedure for rectifying errors in PDCO opinions and European Medicines Agency decisions","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-07-27T16:05:00Z","last_updated_date":"2017-12-01T15:00:00Z","reference_number":"SOP/H/3458","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-rectifying-errors-pdco-opinions-and-european-medicines-agency-decisions_en.pdf"},
    {"id":"35338","name":"Guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/517497/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-medicinal-products-used-weight-control-addendum-weight-control-children_en.pdf"},
    {"id":"35340","name":"Scientific recommendation on classification of advanced therapy medicinal products: Replication incompetent adenoviral vector encoding Interleukin 12 with activator ligand","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/416814/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-replication-incompetent-adenoviral-vector-encoding-interleukin-12-activator-ligand_en.pdf"},
    {"id":"35342","name":"CVMP summary of positive opinion for Panacur AquaSol","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-10-14T17:00:00Z","last_updated_date":"2011-10-14T17:00:00Z","reference_number":"EMA/CVMP/760936/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-panacur-aquasol_en.pdf"},
    {"id":"35343","name":"CHMP summary of positive opinion for Brimica Genuair","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/CHMP/593246/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-brimica-genuair_en.pdf"},
    {"id":"35344","name":"EU/3/06/363: Public summary of positive opinion for orphan designation\n\nof 4-[131I] iodo-L-phenylalanine for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/96512/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306363-public-summary-positive-opinion-orphan-designation-4-131i-iodo-l-phenylalanine-treatment-glioma_en.pdf"},
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    {"id":"35350","name":"Bristol-Myers squibb pharma EEIG withdraws its marketing authorisation application for Ixempra","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-19T01:00:00Z","last_updated_date":"2009-03-19T01:00:00Z","reference_number":"EMEA/177056/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/bristol-myers-squibb-pharma-eeig-withdraws-its-marketing-authorisation-application-ixempra_en.pdf"},
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    {"id":"35394","name":"Sanofi-Aventis Pharma S.A. withdraws its application for an extension of indication for Taxotere and Docetaxel Winthrop (docetaxel)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-11-17T00:09:21Z","last_updated_date":"2008-11-17T00:09:21Z","reference_number":"EMEA/610719/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/sanofi-aventis-pharma-sa-withdraws-its-application-extension-indication-taxotere-and-docetaxel-winthrop-docetaxel_en.pdf"},
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    {"id":"35410","name":"34th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-04-16T02:00:00Z","last_updated_date":"2003-04-16T02:00:00Z","reference_number":"EMEA/COMP/1090/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/34th-meeting-committee-orphan-medicinal-products_en.pdf"},
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    {"id":"35415","name":"EGA-EBG's quality perspective on Biosimilar mAbs - Martin Schiestl","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-07-02T02:09:21Z","last_updated_date":"2009-07-02T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ega-ebgs-quality-perspective-biosimilar-mabs-martin-schiestl_en.pdf"},
    {"id":"35417","name":"Committee for Advanced Therapies (CAT): February 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-03-21T01:00:00Z","reference_number":"EMA/CAT/136236/201","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-february-2011-meeting-monthly-report_en.pdf"},
    {"id":"35418","name":"Presentation - Regulators perspective - Session 2 (Keith Pugh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulators-perspective-session-2-keith-pugh_en.pdf"},
    {"id":"35419","name":"Apomorphine: CMDh scientific conclusions and grounds for the variation,\n\namendments to the product information, and timetable\n\nfor the implementation - PSUSA/00000227/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-30T02:00:00Z","last_updated_date":"2016-10-17T19:40:21Z","reference_number":"EMA/578662/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/apomorphine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000227201511_en.pdf"},
    {"id":"35421","name":"Concept paper on the development of a committee for medicinal\n\nproducts for human use (CHMP) guideline on dosing delivery of\n\ninjectable liquids","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-06-02T02:00:00Z","last_updated_date":"2004-06-02T02:00:00Z","reference_number":"EMEA/CHMP/QWP/1888/04","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-committee-medicinal-products-human-use-chmp-guideline-dosing-delivery-injectable-liquids_en.pdf"},
    {"id":"35423","name":"CHMP summary of positive opinion for Edurant","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-09-23T02:00:00Z","last_updated_date":"2011-09-23T02:00:00Z","reference_number":"EMA/CHMP/724496/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-edurant_en.pdf"},
    {"id":"35425","name":"Presentation - Biomarkers of response/safety for anti-CD19 CAR T cell therapy(Margo Roberts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-biomarkers-responsesafety-anti-cd19-car-t-cell-therapymargo-roberts_en.pdf"},
    {"id":"35426","name":"European Medicines Agency meets with avian flu vaccine manufacturers","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-03-09T01:00:00Z","last_updated_date":"2006-03-09T01:00:00Z","reference_number":"EMEA/86056/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-meets-avian-flu-vaccine-manufacturers_en.pdf"},
    {"id":"35430","name":"EU/3/17/1892: Public summary of opinion on orphan designation: Oxymetazoline hydrochloride for the treatment of spinal cord injury","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2017-08-15T16:00:00Z","last_updated_date":"2017-08-15T16:00:00Z","reference_number":"EMA/404401/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171892-public-summary-opinion-orphan-designation-oxymetazoline-hydrochloride-treatment-spinal-cord-injury_en.pdf"},
    {"id":"35431","name":"Presentation - What can we do now and what are the gaps in our knowledge? The direct thrombin inhibitor (dabigatran etexilate) (Marie Louise S. Christiansen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-can-we-do-now-and-what-are-gaps-our-knowledge-direct-thrombin-inhibitor-dabigatran-etexilate-marie-louise-s-christiansen_en.pdf"},
    {"id":"35432","name":"Danofloxacin (Extension to milk): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-12-01T01:00:00Z","last_updated_date":"1998-12-01T01:00:00Z","reference_number":"EMEA/MRL/507/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/danofloxacin-extension-milk-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35433","name":"Presentation - Workshop opening (Rob Hemmings, Efthymios Manolis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-opening-rob-hemmings-efthymios-manolis_en.pdf"},
    {"id":"35434","name":"Pre-Qualification Questionnaire (PQQ) for a restricted tender procedure organised by European Medicines Agency (EMEA) Supply of telecommunications equipment and consumables EMEA/2008/47/ISERV","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T00:09:21Z","last_updated_date":"2008-11-25T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure-organised-european-medicines-agency-emea-supply-telecommunications-equipment-and-consumables-emea200847iserv_en.doc"},
    {"id":"35435","name":"ICMRA - Mapping of the bilateral arrangements between the ICMRA members","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-01-09T13:20:00Z","last_updated_date":"2017-01-09T13:20:00Z","reference_number":"EMA/562410/2016","document_url":"https://www.ema.europa.eu/en/documents/other/icmra-mapping-bilateral-arrangements-between-icmra-members_en.pdf"},
    {"id":"35436","name":"Presentation - Enpr-EMA WG6: A framework for networks to interact with industry and regulators when implementation/conduct of clinical trials agreed in PIPs is no longer possible (Saul Faust)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-wg6-framework-networks-interact-industry-and-regulators-when-implementationconduct-clinical-trials-agreed-pips-no-longer-possible-saul-faust_en.pdf"},
    {"id":"35437","name":"Presentation - Best expertise vs conflicts of interest: Striking the right balance? (Pierre Chirac)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-best-expertise-vs-conflicts-interest-striking-right-balance-pierre-chirac_en.pdf"},
    {"id":"35438","name":"CHMP post-authorisation summary of positive opinion for Zeffix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zeffix_en.pdf"},
    {"id":"35440","name":"Overview of comments received on ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals (EMA/CHMP/ICH/544278/1998) - Revision 3","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-04-26T12:45:00Z","last_updated_date":"2018-04-26T12:45:00Z","reference_number":"EMA/181369/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-s5-r3-guideline-reproductive-toxicology-detection-toxicity-reproduction-human-pharmaceuticals-emachmpich5442781998-revision-3_en.pdf"},
    {"id":"35441","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 23-24 November 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-12-04T17:27:00Z","last_updated_date":"2015-12-04T17:27:00Z","reference_number":"EMA/HMPC/803211/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-23-24-november-2015_en.pdf"},
    {"id":"35443","name":"Overview of comments received on draft guideline on data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/CVMP/SWP/513604/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-draft-guideline-data-be-provided-support-request-include-substance-list-substances-considered-not-falling-within-scope-regulation-ec-no-4702009_en.pdf"},
    {"id":"35449","name":"Matters relating to the replacement of CFCs in medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1993-12-01T01:00:00Z","last_updated_date":"1993-12-01T01:00:00Z","reference_number":"3BR2A ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/matters-relating-replacement-cfcs-medicinal-products_en.pdf"},
    {"id":"35455","name":"Lactic acid: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lactic-acid-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35456","name":"Valtrex Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-03-25T11:10:00Z","last_updated_date":"2014-03-25T11:10:00Z","reference_number":"EMA/CHMP/79258/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/valtrex-article-30-referral-assessment-report_en.pdf"},
    {"id":"35458","name":"17-03-2011 Decision of the Management Board under Article 16 of the Staff Regulations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-03-21T01:00:00Z","reference_number":"EMA/MB/218686/2011","document_url":"https://www.ema.europa.eu/en/documents/other/17-03-2011-decision-management-board-under-article-16-staff-regulations_en.pdf"},
    {"id":"35459","name":"CHMP summary of positive opinion for Emtricitabine/Tenofovir disoproxil Krka","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-10-14T14:00:00Z","last_updated_date":"2016-10-14T14:00:00Z","reference_number":"EMA/CHMP/651530/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-emtricitabinetenofovir-disoproxil-krka_en.pdf"},
    {"id":"35461","name":"Note for guidance on allergen products (Replaced by CHMP/BWP/304831/07)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1996-03-13T01:00:00Z","last_updated_date":"1996-03-13T01:00:00Z","reference_number":"CPMP/BMP/243/96","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-allergen-products-replaced-chmpbwp30483107_en.pdf"},
    {"id":"35463","name":"Presentation - Electronic submission – industry perspective (Michael Colmorgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronic-submission-industry-perspective-michael-colmorgen_en.pdf"},
    {"id":"35464","name":"EU/3/18/1979: Public summary of opinion on orphan designation: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2020-03-26T14:00:00Z","reference_number":"EMA/67933/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181979-public-summary-opinion-orphan-designation-human-monoclonal-igg2-antibody-against-tissue-factor-pathway-inhibitor-treatment-haemophilia_en.pdf"},
    {"id":"35465","name":"Presentation - Experience from the PROTECT project (Xavier Kurz)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/presentation-experience-protect-project-xavier-kurz_en.pdf"},
    {"id":"35466","name":"Halofuginone: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-11-01T01:00:00Z","last_updated_date":"1998-11-01T01:00:00Z","reference_number":"EMEA/MRL/485/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/halofuginone-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35468","name":"Declaration of interests: Brendan Cuddy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-09T02:00:00Z","last_updated_date":"2019-10-25T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-brendan-cuddy_en.pdf"},
    {"id":"35470","name":"Fenoterol (respiratory indications): List of nationally authorised medicinal products - PSUSA/00001366/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T17:17:00Z","last_updated_date":"2018-05-23T17:22:00Z","reference_number":"EMA/326275/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fenoterol-respiratory-indications-list-nationally-authorised-medicinal-products-psusa00001366201709_en.pdf"},
    {"id":"35473","name":"Report on the first 3-year mandate of the Committee for Orphan Medicinal Products (COMP) April 2000 - April 2003","type":"report","status":"unknown","consultation_date":"","first_published_date":"2003-07-21T02:00:00Z","last_updated_date":"2003-07-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-first-3-year-mandate-committee-orphan-medicinal-products-comp-april-2000-april-2003_en.pdf"},
    {"id":"35474","name":"Tazocin - Article-30 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tazocin-article-30-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tazocin-article-30-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tazocin-article-30-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tazocin-article-30-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tazocin-article-30-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tazocin-article-30-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tazocin-article-30-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tazocin-article-30-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tazocin-article-30-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tazocin-article-30-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tazocin-article-30-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tazocin-article-30-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tazocin-article-30-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tazocin-article-30-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tazocin-article-30-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tazocin-article-30-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tazocin-article-30-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tazocin-article-30-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tazocin-article-30-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tazocin-article-30-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tazocin-article-30-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tazocin-article-30-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/tazocin-article-30-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/tazocin-article-30-referral-annex-i_no.pdf"}},
    {"id":"35475","name":"Opinion of the HMPC on a Community herbal monograph on Ilex paraguariensis St. Hilaire, folium - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-02-14T01:00:00Z","last_updated_date":"2011-02-14T01:00:00Z","reference_number":"EMA/HMPC/282494/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-ilex-paraguariensis-st-hilaire-folium-first-version_en.pdf"},
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    {"id":"35480","name":"Pre-qualification questionnaire (“PQQ”) for a restricted tender procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure_en.doc"},
    {"id":"35481","name":"CHMP post-authorisation summary of positive opinion for Tasigna","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T12:21:00Z","last_updated_date":"2017-09-15T12:21:00Z","reference_number":"EMA/CHMP/595185/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tasigna_en.pdf"},
    {"id":"35482","name":"EU/3/15/1545: Public summary of opinion on orphan designation: CD33-directed antibody-drug conjugate consisting of an antibody conjugated to a DNA cross-linking pyrrolobenzodiazepine dimer drug for the treatment of acute...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2019-07-09T12:00:00Z","reference_number":"EMA/COMP/508236/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151545-public-summary-opinion-orphan-designation-cd33-directed-antibody-drug-conjugate-consisting-antibody-conjugated-dna-cross-linking-pyrrolobenzodiazepine-dimer-drug-treatment-acute_en.pdf"},
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    {"id":"35492","name":"Presentation - Can pharmacokinetics and modelling help?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-can-pharmacokinetics-and-modelling-help_en.pdf"},
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    {"id":"35497","name":"Organisational matters - CHMP meeting 23-26 March 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-04-09T18:00:00Z","last_updated_date":"2015-04-09T18:00:00Z","reference_number":"EMA/27957/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/organisational-matters-chmp-meeting-23-26-march-2015_en.pdf"},
    {"id":"35498","name":"Final list of references supporting the assessment of Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-10-13T11:40:00Z","last_updated_date":"2011-10-13T11:40:00Z","reference_number":"EMA/HMPC/131736/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-viola-arvensis-murray-gaud-and-viola-vulgaris-koch-oborny-herba-cum-flore_en.pdf"},
    {"id":"35500","name":"EuroGen Pharmaceuticals withdraws its application for Orathecin","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-01-23T01:00:00Z","last_updated_date":"2006-01-23T01:00:00Z","reference_number":"EMEA/26219/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/eurogen-pharmaceuticals-withdraws-its-application-orathecin_en.pdf"},
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    {"id":"35506","name":"EMA reviews cancer medicine Zydelig","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T16:30:00Z","last_updated_date":"2016-03-11T16:30:00Z","reference_number":"EMA/191705/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-reviews-cancer-medicine-zydelig_en.pdf"},
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    {"id":"35508","name":"Agenda - Medication-errors workshop - Final programme","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2013-02-27T11:35:00Z","reference_number":"EMA/35980/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medication-errors-workshop-final-programme_en.pdf"},
    {"id":"35509","name":"Tetrazepam-containing medicines - Article-107i procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-05-08T18:00:00Z","last_updated_date":"2013-05-08T18:00:00Z","reference_number":"EMA/279100/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-prac-assessment-report_en.pdf"},
    {"id":"35510","name":"Presentation - Summary of key positions from the discussions: Regulatory (dis)agreement","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summary-key-positions-discussions-regulatory-disagreement_en.pdf"},
    {"id":"35511","name":"Human medicines highlights - July 2018","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T13:12:00Z","last_updated_date":"2018-07-10T13:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-july-2018_en.pdf"},
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    {"id":"35514","name":"Guidelines and concept papers adopted during the CHMP meeting 19-22 January 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-02-02T16:30:00Z","last_updated_date":"2015-02-02T16:30:00Z","reference_number":"EMA/27896/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-19-22-january-2015_en.pdf"},
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    {"id":"35555","name":"Withdrawal assessment report for Pioglitazone Ratiopharm","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2012-07-12T13:55:00Z","last_updated_date":"2012-07-12T13:55:00Z","reference_number":"EMA/394137/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-pioglitazone-ratiopharm_en.pdf"},
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    {"id":"35559","name":"Presentation - New practice for the management of clarification meetings (Pavel Balabanov)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T02:00:00Z","last_updated_date":"2015-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-practice-management-clarification-meetings-pavel-balabanov_en.pdf"},
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    {"id":"35561","name":"Superseded - Overview of comments received on Community herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-05-16T02:00:00Z","last_updated_date":"2018-07-03T02:00:00Z","reference_number":"EMA/HMPC/439318/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizome-first-version_en.pdf"},
    {"id":"35563","name":"List of participants - Training session for patients and consumers involved in European Medicines Agency activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T16:00:00Z","last_updated_date":"2014-02-03T16:00:00Z","reference_number":"EMA/625323/2013","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-training-session-patients-and-consumers-involved-european-medicines-agency-activities_en.pdf"},
    {"id":"35564","name":"Public statement - EU-US FDA bilateral meeting","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2003-09-12T02:00:00Z","last_updated_date":"2003-09-12T02:00:00Z","reference_number":"EMEA/D/24478/03/Final","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-eu-us-fda-bilateral-meeting_en.pdf"},
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    {"id":"35567","name":"Cefodizime : List of nationally authorised medicinal products - PSUSA/00000595/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T12:29:00Z","last_updated_date":"2017-12-01T12:32:47Z","reference_number":"EMA/787582/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefodizime-list-nationally-authorised-medicinal-products-psusa00000595201703_en.pdf"},
    {"id":"35568","name":"EMEA public statement on Replaglinide (NovoNorm/Prandin) contraindication of concomitant use of Replaglinide and Gemfibrozil","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2003-05-21T02:00:00Z","last_updated_date":"2003-05-21T02:00:00Z","reference_number":"EMEA/11700/03","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-replaglinide-novonormprandin-contraindication-concomitant-use-replaglinide-and-gemfibrozil_en.pdf"},
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    {"id":"35570","name":"Opinion of the HMPC on a European Union herbal monograph on Agrimonia eupatoria L., herba - First version","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T13:00:00Z","last_updated_date":"2015-04-09T13:00:00Z","reference_number":"EMA/HMPC/61599/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-agrimonia-eupatoria-l-herba-first-version_en.pdf"},
    {"id":"35573","name":"Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T17:20:00Z","last_updated_date":"2017-09-06T17:20:00Z","reference_number":"EMA/524592/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-hydrochloride-phenylephrine-hydrochloride-tropicamide-list-nationally-authorised-medicinal-products-psusa00010390201701_en.pdf"},
    {"id":"35574","name":"Draft list of references supporting the assessment of Potentilla erecta (L.) Raeusch., rhizome","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/HMPC/5517/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-potentilla-erecta-l-raeusch-rhizome_en.pdf"},
    {"id":"35575","name":"Polyoxyethylene sorbitan monooleate: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-09-01T02:00:00Z","last_updated_date":"2005-09-01T02:00:00Z","reference_number":"EMEA/CVMP/263823/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/polyoxyethylene-sorbitan-monooleate-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35577","name":"EU/3/14/1345: Public summary of opinion on orphan designation: Osilodrostat for the treatment of Cushing's syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/552875/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141345-public-summary-opinion-orphan-designation-osilodrostat-treatment-cushings-syndrome_en.pdf"},
    {"id":"35581","name":"Rocephin Article-30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T01:00:00Z","last_updated_date":"2014-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/rocephin-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/rocephin-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/rocephin-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/rocephin-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/rocephin-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/rocephin-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/rocephin-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/rocephin-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/rocephin-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/rocephin-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/rocephin-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/rocephin-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/rocephin-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/rocephin-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/rocephin-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/rocephin-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/rocephin-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/rocephin-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/rocephin-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/rocephin-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/rocephin-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/rocephin-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/rocephin-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/rocephin-article-30-referral-annex-iii_is.pdf"}},
    {"id":"35582","name":"EU/3/15/1474: Public summary of positive opinion for orphan designation of Ecothiopate iodide for the treatment of Stargardt’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-21T14:00:00Z","last_updated_date":"2015-05-21T14:00:00Z","reference_number":"EMA/COMP/211400/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151474-public-summary-positive-opinion-orphan-designation-ecothiopate-iodide-treatment-stargardts-disease_en.pdf"},
    {"id":"35584","name":"Highlights of 100th Management Board meeting: June 2018","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/379969/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/highlights-100th-management-board-meeting-june-2018_en.pdf"},
    {"id":"35585","name":"EU/3/10/732: Public summary of opinion on orphan designation: Entinostat for the treatment of Hodgkin’s lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2015-05-27T13:15:00Z","reference_number":"EMA/COMP/90806/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310732-public-summary-opinion-orphan-designation-entinostat-treatment-hodgkins-lymphoma_en.pdf"},
    {"id":"35586","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 21-22 November 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-10-23T02:09:21Z","last_updated_date":"2003-10-23T02:09:21Z","reference_number":"EMEA/CPMP/5259/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-21-22-november-2003_en.pdf"},
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    {"id":"35600","name":"Draft list of references supporting the assessment of Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-07-24T02:00:00Z","last_updated_date":"2014-07-24T02:00:00Z","reference_number":"EMA/HMPC/55810/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-matricaria-recutita-l-flos-and-matricaria-recutita-l-aetheroleum-first-version_en.pdf"},
    {"id":"35604","name":"EMEA Viewpoint on the Innovative Medicines Initiative - Pharmacovigilance - Xavier Kurz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/emea-viewpoint-innovative-medicines-initiative-pharmacovigilance-xavier-kurz_en.pdf"},
    {"id":"35605","name":"Presentation - The TYSEDMUS Study, Christian Confavreux","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-tysedmus-study-christian-confavreux_en.pdf"},
    {"id":"35607","name":"Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-10T16:00:00Z","last_updated_date":"2016-02-10T16:00:00Z","reference_number":"SOP/H/3462","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-eligibility-centralised-procedure-medicinal-products-human-use_en.pdf"},
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    {"id":"35611","name":"Start of Community reviews - CHMP meeting of 16-19 July 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T17:00:00Z","last_updated_date":"2012-07-20T17:00:00Z","reference_number":"EMA/483585/2012","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-16-19-july-2012_en.pdf"},
    {"id":"35612","name":"Fentrix Article-29(4) referral - Annexes I, II and II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:00:00Z","last_updated_date":"2009-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fentrix-article-294-referral-annexes-i-ii-and-ii_sv.pdf"}},
    {"id":"35613","name":"EU/3/16/1639: Public summary of opinion on orphan designation: (1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione for the treatment of X-linked spinal and bulbar muscular atrophy (Kennedy’s ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-31T02:00:00Z","last_updated_date":"2016-11-29T01:00:00Z","reference_number":"EMA/COMP/254125/2016 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161639-public-summary-opinion-orphan-designation-1e6e-17-bis34-dimethoxyphenyl-4-cyclobutylmethyl-16-heptadiene-35-dione-treatment-x-linked-spinal-and-bulbar-muscular-atrophy-kennedys_en.pdf"},
    {"id":"35614","name":"Agenda - Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicinal products","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-10-17T16:27:00Z","last_updated_date":"2017-10-17T16:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-industry-stakeholder-teleconference-brexit-and-operation-centralised-procedure-veterinary-medicinal-products_en.pdf"},
    {"id":"35615","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - December 2009","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-02-10T01:00:00Z","last_updated_date":"2010-02-10T01:00:00Z","reference_number":"EMA/CVMP/69430/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-december-2009_en.pdf"},
    {"id":"35616","name":"Report - Workshop on the patient’s voice in the evaluation of medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-10-29T15:30:00Z","last_updated_date":"2013-10-29T15:30:00Z","reference_number":"EMA/607864/2013","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-patients-voice-evaluation-medicines_en.pdf"},
    {"id":"35619","name":"Withdrawal letter: Alendronic Acid/Colecalciferol Mylan","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-alendronic-acidcolecalciferol-mylan_en.pdf"},
    {"id":"35620","name":"Naproxen: List of nationally authorised medicinal products - PSUSA/00002125/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T13:00:00Z","last_updated_date":"2018-06-07T15:52:37Z","reference_number":"EMA/382206/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/naproxen-list-nationally-authorised-medicinal-products-psusa00002125201708_en.pdf"},
    {"id":"35623","name":"Metoclopramide Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-10-25T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metoclopramide-article-31-referral-annex-iii_en.pdf-0"},
    {"id":"35624","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-12-17T14:55:00Z","last_updated_date":"2013-05-16T17:00:00Z","reference_number":"EMA/CHMP/ICH/529785/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q4b-annex-14-note-evaluation-and-recommendation-pharmacopoeial-texts-use_en.pdf"},
    {"id":"35625","name":"Gadoxetic acid disodium: List of nationally authorised medicinal products - PSUSA/00001509/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-17T01:00:00Z","last_updated_date":"2016-10-18T16:56:39Z","reference_number":"EMA/200877/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoxetic-acid-disodium-list-nationally-authorised-medicinal-products-psusa00001509201504_en.pdf"},
    {"id":"35627","name":"Veterinarians and bee health involvement, taking France as an example, Nicolas Vidal-Naquet, Federation of Veterinarians of Europe (FVE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/veterinarians-and-bee-health-involvement-taking-france-example-nicolas-vidal-naquet-federation-veterinarians-europe-fve_en.pdf"},
    {"id":"35629","name":"Concept paper on vaccines used for vaccination against foot and mouth disease","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2001-06-01T02:00:00Z","last_updated_date":"2001-06-01T02:00:00Z","reference_number":"EMEA/CVMP/518/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-vaccines-used-vaccination-against-foot-and-mouth-disease_en.pdf"},
    {"id":"35630","name":"EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) authorisation procedures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:00Z","last_updated_date":"2021-09-14T09:15:00Z","reference_number":"EMA/136152/2012 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-xevmpd-authorisation-procedures_en.xls"},
    {"id":"35631","name":"Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management with tracked changes (Rev. 1)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-10-12T12:30:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/827661/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-tracked-changes-rev-1_en.pdf"},
    {"id":"35632","name":"PRAC concludes review of Zydelig and issues updated recommendations for use","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/459461/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-concludes-review-zydelig-and-issues-updated-recommendations-use_en.pdf"},
    {"id":"35633","name":"Presentation - Treatment guidelines for relapsing MS and the ‘two step approach’ for disease modifying therapy (Klaus Schmierer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-treatment-guidelines-relapsing-ms-and-two-step-approach-disease-modifying-therapy-klaus-schmierer_en.pdf"},
    {"id":"35635","name":"Presentation - EMA experience with Art. 46 of Regulation (EC) No 1901/2006","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-experience-art-46-regulation-ec-no-19012006_en.pdf"},
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    {"id":"35692","name":"The role of the PDCO - Gà©rard Pons","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/role-pdco-gacrard-pons_en.pdf"},
    {"id":"35693","name":"EU/3/12/1088: Public summary of opinion on orphan designation: Allogeneic motor-neuron progenitor cells derived from human embryonic stem cells for the treatment of 5q spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/2194/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121088-public-summary-opinion-orphan-designation-allogeneic-motor-neuron-progenitor-cells-derived-human-embryonic-stem-cells-treatment-5q-spinal-muscular-atrophy_en.pdf"},
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    {"id":"35713","name":"Unparalleled access to clinical data - one year on","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-10-20T02:00:00Z","last_updated_date":"2017-10-20T02:00:00Z","reference_number":"EMA/682188/2017 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/unparalleled-access-clinical-data-one-year_en.pdf"},
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    {"id":"35722","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Calcium Sandoz and associated names International Non-Proprietary Name (INN): Calcium lactate 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    {"id":"35725","name":"Reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-05-23T10:57:00Z","last_updated_date":"2017-05-23T10:57:00Z","reference_number":"EMA/CVMP/448211/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-authorisation-veterinary-medicinal-products-containing-potential-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpvb-substances_en.pdf"},
    {"id":"35727","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous chondrocytes","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:00:00Z","last_updated_date":"2015-08-26T12:00:00Z","reference_number":"EMA/557326/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-autologous-chondrocytes_en.pdf"},
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    {"id":"35812","name":"Ketoconazole Article-31 referral - Suspension of marketing authorisations for oral ketoconazole","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-13T02:00:00Z","last_updated_date":"2014-06-13T02:00:00Z","reference_number":"EMA/584237/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ketoconazole-article-31-referral-suspension-marketing-authorisations-oral-ketoconazole_sv.pdf"}},
    {"id":"35815","name":"Questions and answers on Merisone and Myoson (tolperisone, 50 and 150 mg tablets)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-07-28T14:00:00Z","reference_number":"EMA/252261/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_bg.pdf-0","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_es.pdf-0","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_cs.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_de.pdf-0","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_et.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_fr.pdf-0","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_hr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_it.pdf-0","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_lv.pdf-0","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_lt.pdf-0","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_hu.pdf-0","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_mt.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_nl.pdf-0","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_pl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_pt.pdf-0","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_ro.pdf-0","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_sk.pdf-0","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_sl.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-merisone-and-myoson-tolperisone-50-and-150-mg-tablets_sv.pdf-0"}},
    {"id":"35816","name":"Dear Health Care Professional Letter on 3rd Generation Cocs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2001-09-28T02:00:00Z","last_updated_date":"2001-09-28T02:00:00Z","reference_number":"EMEA/CPMP/2225/01/en/Final","document_url":"https://www.ema.europa.eu/en/documents/other/dear-health-care-professional-letter-3rd-generation-cocs_en.pdf"},
    {"id":"35817","name":"Questions and answers on the withdrawal of the marketing authorisation application for Pioglitazone ratio","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-07-12T02:00:00Z","reference_number":"EMA/281366/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-pioglitazone-ratio_sv.pdf"}},
    {"id":"35820","name":"Presentation - Antimicrobial drug development: Role and importance of the regulatory requirements - Session 2 (Mair Powell)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antimicrobial-drug-development-role-and-importance-regulatory-requirements-session-2-mair-powell_en.pdf"},
    {"id":"35822","name":"Cypermethrin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-09-01T02:00:00Z","last_updated_date":"2001-09-01T02:00:00Z","reference_number":"EMEA/MRL/801/01-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cypermethrin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"35823","name":"CHMP summary of positive opinion for Bosulif","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-01-18T13:00:00Z","last_updated_date":"2013-01-18T13:00:00Z","reference_number":"EMA/CHMP/4601/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bosulif_en.pdf"},
    {"id":"35824","name":"Tibolona-Article 29(4) referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-08T02:00:00Z","last_updated_date":"2014-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tibolona-article-294-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tibolona-article-294-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tibolona-article-294-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tibolona-article-294-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tibolona-article-294-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tibolona-article-294-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tibolona-article-294-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tibolona-article-294-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tibolona-article-294-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/tibolona-article-294-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tibolona-article-294-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tibolona-article-294-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tibolona-article-294-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tibolona-article-294-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tibolona-article-294-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tibolona-article-294-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tibolona-article-294-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tibolona-article-294-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tibolona-article-294-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tibolona-article-294-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tibolona-article-294-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tibolona-article-294-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tibolona-article-294-referral-annex-i_sv.pdf"}},
    {"id":"35825","name":"Colistin - Article 35 referral - Annexes I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2010-06-24T02:00:00Z","reference_number":"EMA/189829/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/colistin-article-35-referral-annexes-i-ii-iii_sv.pdf"}},
    {"id":"35828","name":"Draft Community herbal monograph on Thymus vulgaris L. and Thymus zygis Loefl. ex L., aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2009-05-14T02:09:21Z","reference_number":"EMEA/HMPC/131901/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-loefl-ex-l-aetheroleum_en.pdf"},
    {"id":"35829","name":"Presentation - Type-2-diabetes-paediatric-investigation-plan overview (Janina Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-type-2-diabetes-paediatric-investigation-plan-overview-janina-karres_en.pdf"},
    {"id":"35830","name":"Presentation - Cabozantinib (Cometriq) (Frans Opdam)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cabozantinib-cometriq-frans-opdam_en.pdf"},
    {"id":"35831","name":"CVMP summary of opinion for Melovem","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T03:09:21Z","last_updated_date":"2009-05-15T03:09:21Z","reference_number":"EMEA/CVMP/247920/2009 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-opinion-melovem_en.pdf"},
    {"id":"35832","name":"Presentation - Stakeholder experiences: Stakeholder experiences - Marketing Authorisation Holder view by EGGVP and IFAH-Europe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-16T02:00:00Z","last_updated_date":"2017-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stakeholder-experiences-stakeholder-experiences-marketing-authorisation-holder-view-eggvp-and-ifah-europe_en.pdf"},
    {"id":"35833","name":"EU/3/16/1625: Public summary of opinion on orphan designation: Acalabrutinib for the treatment of mantle cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"EMA/COMP/150795/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161625-public-summary-opinion-orphan-designation-acalabrutinib-treatment-mantle-cell-lymphoma_en.pdf"},
    {"id":"35834","name":"Opinion following an Article 5(11)  referral for Belanette and associated names (see Annex I) International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol: Background 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    {"id":"35840","name":"Reflection paper on the use of fluoroquinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-01-18T01:00:00Z","last_updated_date":"2006-01-18T01:00:00Z","reference_number":"EMEA/CVMP/SAGAM/184651/2005-CONS","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-use-fluoroquinolones-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"35842","name":"Presentation - European Orphan Designation: Legal basis (Agnes Mathieu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-orphan-designation-legal-basis-agnes-mathieu_en.pdf"},
    {"id":"35846","name":"Superseded final community herbal monograph on Verbascum thapsus L., V. densiflorum Bertol and V. phlomoides L., flos","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/HMPC/395213/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-verbascum-thapsus-l-v-densiflorum-bertol-and-v-phlomoides-l-flos_en.pdf"},
    {"id":"35848","name":"Final assessment report on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/HMPC/573240/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"35849","name":"CHMP post-authorisation summary of positive opinion for Cervarix","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/389753/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cervarix_en.pdf-1"},
    {"id":"35852","name":"Presentation - Study recruitment issues (Phillip Ambery)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-study-recruitment-issues-phillip-ambery_en.pdf"},
    {"id":"35853","name":"Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for bloo...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-09-30T02:09:21Z","last_updated_date":"2005-09-30T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/commission-directive-200562ec-30-september-2005-implementing-directive-200298ec-european-parliament-and-council-regards-community-standards-and-specifications-relating-quality-system-bloo_en.pdf"},
    {"id":"35854","name":"Guideline on clinical investigation of medicinal products in the treatment of lipid disorders","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-01-16T16:10:00Z","last_updated_date":"2014-01-16T16:10:00Z","reference_number":"EMA/CHMP/748108/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders_en.pdf"},
    {"id":"35855","name":"Presentation - Health data to support medicines regulation, Dr Arlett","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-01-20T01:00:00Z","last_updated_date":"2011-01-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-health-data-support-medicines-regulation-dr-arlett_en.pdf"},
    {"id":"35858","name":"EU/3/01/080: Public summary of positive opinion for orphan designation of human engineered monoclonal antibody specific for transforming growth factor àŸ1 (TGF- àŸ1) for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-23T01:00:00Z","last_updated_date":"2007-02-23T01:00:00Z","reference_number":"EMEA/COMP/74/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301080-public-summary-positive-opinion-orphan-designation-human-engineered-monoclonal-antibody-specific-transforming-growth-factor-ay1-tgf-ay1-treatment-systemic-sclerosis_en.pdf"},
    {"id":"35859","name":"Agenda - PRAC draft agenda of meeting 3-5 September 2012","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2012-09-03T14:00:00Z","last_updated_date":"2012-09-03T14:00:00Z","reference_number":"EMA/PRAC/432046/2012","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-3-5-september-2012_en.pdf"},
    {"id":"35860","name":"CHMP post-authorisation summary of positive opinion for Velcade","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/CHMP/252977/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-velcade_en.pdf-2"},
    {"id":"35862","name":"Declaration of interests: Amanda Johannson","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:06:55Z","last_updated_date":"2015-09-01T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-amanda-johannson_en.pdf"},
    {"id":"35863","name":"Qualification opinion on paediatric ulcerative colitis activity index (PUCAI)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-01-20T17:10:00Z","last_updated_date":"2016-01-20T17:10:00Z","reference_number":"EMA/CHMP/SAWP/801872/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-paediatric-ulcerative-colitis-activity-index-pucai_en.pdf"},
    {"id":"35865","name":"Presentation - Reinforcing the collaboration with healthcare professionals and patient associations - ANSM (Dany Bonnet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reinforcing-collaboration-healthcare-professionals-and-patient-associations-ansm-dany-bonnet_en.pdf-0"},
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    {"id":"35869","name":"EU/3/15/1542: Public summary of opinion on orphan designation: 2’-deoxyguanosylyl-(3’,5’-phosphoryl)-2’-deoxythymidylyl-(3’,5’-phosphoryl)- 2’-deoxyguanosylyl-(3’,5’-phosphoryl)-2’-deoxycytidylyl-(3’,5’-phosphoryl)-2’-de...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-10-02T02:00:00Z","last_updated_date":"2016-10-21T02:00:00Z","reference_number":"EMA/COMP/508488/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151542-public-summary-opinion-orphan-designation-2-deoxyguanosylyl-35-phosphoryl-2-deoxythymidylyl-35-phosphoryl-2-deoxyguanosylyl-35-phosphoryl-2-deoxycytidylyl-35-phosphoryl-2-de_en.pdf"},
    {"id":"35870","name":"List on additional controlled terminology for electronic submission of reports on adverse reactions to veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-12-08T00:09:21Z","last_updated_date":"2006-09-15T01:09:21Z","reference_number":"EMEA/CVMP/556/04- Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/list-additional-controlled-terminology-electronic-submission-reports-adverse-reactions-veterinary-medicinal-products_en.pdf"},
    {"id":"35871","name":"European Medicines Agency pharmacovigilance system manual","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-29T18:40:00Z","last_updated_date":"2021-03-16T10:27:00Z","reference_number":"EMA/623550/2013 Version 1.3","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-pharmacovigilance-system-manual_en.pdf"},
    {"id":"35874","name":"Presentation - Scientific and regulatory evaluation procedure support [S-REPS] pilot update / system preview (Sylvie Beausuroy, Paolo Tomasi, Bob Coggins)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:16:00Z","last_updated_date":"2018-06-06T17:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-and-regulatory-evaluation-procedure-support-s-reps-pilot-update-system-preview-sylvie-beausuroy-paolo-tomasi-bob-coggins_en.pdf"},
    {"id":"35879","name":"Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the European Economic Area (Bucharest, Romania)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-01-26T16:30:00Z","last_updated_date":"2017-01-26T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-icsrs-european-economic-area-bucharest-romania_en.pdf"},
    {"id":"35881","name":"Work plan for the Biosimilar Medicinal Products Working Party 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T16:00:00Z","last_updated_date":"2018-01-18T16:30:00Z","reference_number":"EMA/CHMP/BMWP/420509/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-biosimilar-medicinal-products-working-party-2018_en.pdf"},
    {"id":"35883","name":"Public statement on Teslascan: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-08-02T16:00:00Z","last_updated_date":"2012-08-02T16:00:00Z","reference_number":"EMA/486286/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-teslascan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"35887","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations: Oncolytic viruses","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-10-21T02:00:00Z","last_updated_date":"2009-10-21T02:00:00Z","reference_number":"EMEA/CHMP/ICH/607698/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-considerations-oncolytic-viruses_en.pdf"},
    {"id":"35888","name":"EU/3/14/1402: Public summary of opinion on orphan designation: Benserazide hydrochloride for the treatment of beta thalassaemia intermedia and major","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-27T01:00:00Z","last_updated_date":"2015-02-27T01:00:00Z","reference_number":"EMA/COMP/736552/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141402-public-summary-opinion-orphan-designation-benserazide-hydrochloride-treatment-beta-thalassaemia-intermedia-and-major_en.pdf"},
    {"id":"35889","name":"Career opportunities at the European Medicines Agency","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2015-05-18T18:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/career-opportunities-european-medicines-agency_en.pdf"},
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    {"id":"35914","name":"EU/3/17/1832: Public summary of opinion on orphan designation: Alpha-tocopherol and ascorbic acid for treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/83323/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171832-public-summary-opinion-orphan-designation-alpha-tocopherol-and-ascorbic-acid-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"35917","name":"Lincomycin and spectinomycin Article 35 referral - Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or 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    {"id":"35934","name":"CHMP summary of positive opinion for Picato","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2020-03-04T02:00:00Z","reference_number":"EMA/CHMP/553672/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-picato_en.pdf"},
    {"id":"35935","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2016 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-04-05T16:25:00Z","last_updated_date":"2016-04-05T16:25:00Z","reference_number":"EMA/CAT/237075/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-march-2016-meeting_en.pdf"},
    {"id":"35936","name":"Tulathromycin (ovine and caprine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-02-24T12:00:00Z","last_updated_date":"2015-02-24T12:00:00Z","reference_number":"EMA/CVMP/131462/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tulathromycin-ovine-and-caprine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"35937","name":"Soya-bean lecithin - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2018-01-05T11:35:00Z","last_updated_date":"2018-01-05T11:35:00Z","reference_number":"EMA/90100/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/soya-bean-lecithin-summary-public_en.pdf"},
    {"id":"35938","name":"CHMP summary of positive opinion for Temozolomide Hexal","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2023-02-27T15:53:00Z","reference_number":"EMA/CHMP/810041/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-temozolomide-hexal_en.pdf"},
    {"id":"35940","name":"Presentation - Basis for setting acceptance criteria, Mats Welin, Swedish Medical Products Agency","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-06T02:00:00Z","last_updated_date":"2011-10-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-basis-setting-acceptance-criteria-mats-welin-swedish-medical-products-agency_en.pdf"},
    {"id":"35941","name":"Agenda and registration form - individual case safety report information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-03-23T15:00:01Z","last_updated_date":"2015-03-24T14:00:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-individual-case-safety-report-information-day_en.pdf"},
    {"id":"35945","name":"EU/3/05/299: Public summary of positive opinion for orphan designation of 4-imino-1, 3-diazobicyclo-[3.1.0]-hexan-2-one for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T01:00:00Z","last_updated_date":"2005-11-29T01:00:00Z","reference_number":"EMEA/COMP/202020/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305299-public-summary-positive-opinion-orphan-designation-4-imino-1-3-diazobicyclo-310-hexan-2-one-treatment-pancreatic-cancer_en.pdf"},
    {"id":"35946","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Autologous mesenchymal stromal cells secreting neurotrophic factors","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T13:30:00Z","last_updated_date":"2013-03-08T13:30:00Z","reference_number":"EMA/81707/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-mesenchymal-stromal-cells-secreting-neurotrophic-factors_en.pdf"},
    {"id":"35947","name":"Presentation - Interaction with patients, consumers and healthcare professionals: Raising awareness (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-patients-consumers-and-healthcare-professionals-raising-awareness-nathalie-bere_en.pdf"},
    {"id":"35948","name":"Opinions on safety variations September 2016 adopted at the CHMP meeting of 12-15 September 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-09-23T18:35:00Z","last_updated_date":"2016-09-23T18:35:00Z","reference_number":"EMA/76624/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variations-september-2016-adopted-chmp-meeting-12-15-september-2016_en.pdf"},
    {"id":"35951","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Susanne Zà¤nker","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-susanne-zanker_en.pdf"},
    {"id":"35953","name":"Presentation - The European Centre for Disease Prevention and Control (ECDC) point of view on the requests from the European Commission (Anna-Pelagia Magiorakos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-centre-disease-prevention-and-control-ecdc-point-view-requests-european-commission-anna-pelagia-magiorakos_en.pdf"},
    {"id":"35954","name":"Desfluran: List of nationally authorised medicinal products - PSUSA/0000958/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-07-16T14:00:00Z","last_updated_date":"2016-10-17T20:37:52Z","reference_number":"EMA/456329/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/desfluran-list-nationally-authorised-medicinal-products-psusa0000958201409_en.pdf"},
    {"id":"35956","name":"Presentation - A dedicated post-authorisation measure submission form: an improved way of submitting your PAM to the EMA (Hector Boix Perales)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-16T16:30:00Z","last_updated_date":"2018-01-16T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-dedicated-post-authorisation-measure-submission-form-improved-way-submitting-your-pam-ema-hector-boix-perales_en.pdf"},
    {"id":"35958","name":"Presentation - Gadolinium-containing magnetic resonance contrast agents and communication practices in European Union Member States","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T01:00:00Z","last_updated_date":"2011-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gadolinium-containing-magnetic-resonance-contrast-agents-and-communication-practices-european-union-member-states_en.pdf-0"},
    {"id":"35959","name":"Levonorgestrel and ulipristal remain suitable emergency contraceptives for all women, regardless of bodyweight","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-07-24T02:00:00Z","last_updated_date":"2014-07-24T02:00:00Z","reference_number":"EMA/440549/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/levonorgestrel-and-ulipristal-remain-suitable-emergency-contraceptives-all-women-regardless-bodyweight_en.pdf"},
    {"id":"35961","name":"Presentation - Populating organs-on-chip with cells derived from human stem cells (C. Mummery)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T11:22:00Z","last_updated_date":"2017-11-15T11:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-populating-organs-chip-cells-derived-human-stem-cells-c-mummery_en.pdf"},
    {"id":"35962","name":"Committee for medicinal products for human use, summary of positive opinion for IDflu","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T01:00:00Z","last_updated_date":"2018-03-28T02:00:00Z","reference_number":"EMEA/CHMP/642949/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-idflu_en.pdf"},
    {"id":"35965","name":"CHMP post-authorisation summary of positive opinion for Pradaxa","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/252976/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pradaxa_en.pdf-4"},
    {"id":"35968","name":"Update on review of recalled valsartan medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-08-02T02:00:00Z","last_updated_date":"2018-08-02T02:00:00Z","reference_number":"EMA/526031/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-review-recalled-valsartan-medicines_en.pdf"},
    {"id":"35969","name":"Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"EMEA/CHMP/EWP/139391/2004","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation-medicinal-products_en.pdf"},
    {"id":"35970","name":"Minutes of the annual European network of paediatric research at the European Medicines Agency members meeting - 26 June 2014","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2015-02-02T15:00:00Z","last_updated_date":"2015-02-02T15:00:00Z","reference_number":"EMA/408421/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-annual-european-network-paediatric-research-european-medicines-agency-members-meeting-26-june-2014_en.pdf"},
    {"id":"35971","name":"Guidance on format of the risk-management plan in the European Union part II: Module SII - Non-clinical part of the safety specification","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2013-08-21T18:35:00Z","reference_number":"EMA/465926/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-sii-non-clinical-part-safety-specification_en.pdf"},
    {"id":"35972","name":"Overview of comments received on 'Guideline on the clinical investigation of hepatitis B immunoglobulins'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T10:35:00Z","last_updated_date":"2015-07-24T10:35:00Z","reference_number":"EMA/CHMP/BPWP/356886/2013","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-hepatitis-b-immunoglobulins_en.pdf"},
    {"id":"35976","name":"Minutes of the 78th meeting of the Management Board: 13 December 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/MB/810387/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-78th-meeting-management-board-13-december-2012_en.pdf"},
    {"id":"35979","name":"Scientific recommendation on classification of advanced therapy medicinal products: Ex vivo expanded adipose-derived stem cells suspension","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-04T19:15:00Z","last_updated_date":"2016-04-04T19:15:00Z","reference_number":"EMA/555245/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-ex-vivo-expanded-adipose-derived-stem-cells-suspension_en.pdf"},
    {"id":"35981","name":"EU/3/01/032: Public summary of positive opinion for orphan designation of arsenic trioxide for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-04T02:00:00Z","last_updated_date":"2010-03-15T01:00:00Z","reference_number":"EMA/COMP/10959/2003 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301032-public-summary-positive-opinion-orphan-designation-arsenic-trioxide-treatment-multiple-myeloma_en.pdf"},
    {"id":"35983","name":"Ancillary - Day 80 Overview template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:30:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-80-overview-template-rev1016_en.doc"},
    {"id":"35984","name":"Draft guideline on the SPC for anthelmintics","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-06-26T02:09:21Z","last_updated_date":"2006-06-26T02:09:21Z","reference_number":"EMEA/CVMP/EWP/170208/2005-CONSULTATION","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-spc-anthelmintics_en.pdf"},
    {"id":"35986","name":"Quinine: List of nationally authorised medicinal products - PSUSA/00002598/201611","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-24T19:20:00Z","last_updated_date":"2017-10-24T19:20:00Z","reference_number":"EMA/710254/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/quinine-list-nationally-authorised-medicinal-products-psusa00002598201611_en.pdf"},
    {"id":"35987","name":"Annex II to procedure for conducting GCP inspections requested by the CHMP: Clinical laboratories","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2022-05-05T13:27:00Z","reference_number":"EMA/INS/GCP/154768/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-ii-procedure-conducting-gcp-inspections-requested-chmp-clinical-laboratories_en.pdf"},
    {"id":"35991","name":"Moxidectin Article-35 referral - Annex I, II, III, IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/moxidectin-article-35-referral-annex-i-ii-iii-iv_sv.pdf"}},
    {"id":"35992","name":"Keppra: EMA recommends measures to ensure safe use of oral solution","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"EMA/668736/2016","document_url":"https://www.ema.europa.eu/en/documents/medication-error/keppra-ema-recommends-measures-ensure-safe-use-oral-solution_en.pdf"},
    {"id":"35993","name":"Draft revised entry to list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products: Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2014-10-28T15:00:00Z","reference_number":"EMA/HMPC/680616/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-revised-entry-list-herbal-substances-preparations-and-combinations-thereof-use-traditional-herbal-medicinal-products-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
    {"id":"35994","name":"Presentation - CHMP's view on multiplicity through assessment, advice and guidelines (Rob Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmps-view-multiplicity-through-assessment-advice-and-guidelines-rob-hemmings_en.pdf"},
    {"id":"35995","name":"A Review of the Medicines Legislation by the EMEA and National Competent Authorities - Joint EMEA/TO PRA meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-12-03T01:00:00Z","last_updated_date":"2007-12-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/review-medicines-legislation-emea-and-national-competent-authorities-joint-emeato-pra-meeting_en.pdf"},
    {"id":"35996","name":"Presentation -  Reporting of adverse drug reactions by patients – Croatian experience (Marina Giusti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reporting-adverse-drug-reactions-patients-croatian-experience-marina-giusti_en.pdf"},
    {"id":"35998","name":"EU/3/16/1672: Public summary of opinion on orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/384024/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161672-public-summary-opinion-orphan-designation-3-5-amino-2-methyl-4-oxoquinazolin-34h-ylpiperidine-26-dione-hydrochloride-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"36001","name":"Committee for Advanced Therapies (CAT): January 2010 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-01-27T00:09:21Z","last_updated_date":"2010-01-27T00:09:21Z","reference_number":"EMA/CAT/38910/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-january-2010-meeting-monthly-report_en.pdf"},
    {"id":"36002","name":"Presentation - European Union -  lumpy skin disease and other exotic diseases antigen/vaccine banks:  Current status, policy and future considerations (Andrea Gavinelli and Dimitrios Dilaveris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T11:37:00Z","last_updated_date":"2017-05-18T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-union-lumpy-skin-disease-and-other-exotic-diseases-antigenvaccine-banks-current-status-policy-and-future-considerations-andrea-gavinelli-and-dimitrios-dilaveris_en.pdf"},
    {"id":"36004","name":"EU/3/16/1725 : Public summary of opinion on orphan designation: Public summary of opinion on orphan designation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161725-public-summary-opinion-orphan-designation-public-summary-opinion-orphan-designation_en.pdf"},
    {"id":"36005","name":"Draft community list entry on Pimpinella anisum L., fructus","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-07-05T02:09:21Z","last_updated_date":"2007-07-05T02:09:21Z","reference_number":"EMEA/HMPC/297757/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-pimpinella-anisum-l-fructus_en.pdf"},
    {"id":"36006","name":"Presentation - Active pharmaceutical ingredients – The new approach for third countries: What are the consequences? Should we expect shortage of medicinal products in the country? - Perspectives from an acceding country ...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-active-pharmaceutical-ingredients-new-approach-third-countries-what-are-consequences-should-we-expect-shortage-medicinal-products-country-perspectives-acceding-country_en.pdf"},
    {"id":"36009","name":"CVMP summary of positive opinion for Galliprant","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"EMA/CVMP/673968/017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-galliprant_en.pdf"},
    {"id":"36011","name":"One-year conditional renewals (60-day procedure)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-10-25T01:09:21Z","last_updated_date":"2007-10-25T01:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/one-year-conditional-renewals-60-day-procedure_en.pdf"},
    {"id":"36012","name":"Annex 11 Financial identification form - EMA-2012-09-IF","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-27T11:00:00Z","last_updated_date":"2012-02-27T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annex-11-financial-identification-form-ema-2012-09-if_en.xls"},
    {"id":"36014","name":"EU/3/17/1925 : Public summary of opinion on orphan designation : Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F for the treatment of multiple my...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T15:38:00Z","last_updated_date":"2018-01-08T15:38:00Z","reference_number":"EMA/632132/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171925-public-summary-opinion-orphan-designation-humanised-monoclonal-antibody-targeting-b-cell-maturation-antigen-conjugated-maleimidocaproyl-monomethyl-auristatin-f-treatment-multiple-my_en.pdf"},
    {"id":"36016","name":"Agenda - Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-05-19T17:10:00Z","last_updated_date":"2016-09-09T11:50:00Z","reference_number":"EMA/26126/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshops-micro-small-and-medium-sized-enterprises-focus-non-clinical-aspects_en.pdf"},
    {"id":"36018","name":"Technical specification - Annex 3 Lot 1 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T01:00:00Z","last_updated_date":"2013-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-3-lot-1-external-service-providers-software-applications-ema201213ict_en.xls"},
    {"id":"36019","name":"EU/3/16/1777: Public summary of positive opinion for orphan designation of brincidofovir for the treatment of smallpox","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T15:43:00Z","last_updated_date":"2016-12-14T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161777-public-summary-positive-opinion-orphan-designation-brincidofovir-treatment-smallpox_en.pdf"},
    {"id":"36021","name":"CHMP summary of positive opinion for Hefiya","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/CHMP/241971/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hefiya_en.pdf"},
    {"id":"36023","name":"ICH: E 2 C (R1): Clinical safety data management: Periodic safety update reports for marketed drugs - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1997-06-01T02:00:00Z","last_updated_date":"1997-06-01T02:00:00Z","reference_number":"CPMP/ICH/288/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-2-c-r1-clinical-safety-data-management-periodic-safety-update-reports-marketed-drugs-step-5_en.pdf"},
    {"id":"36024","name":"Quality Review of Documents general principles regarding the summary-of-product-characteristics information for a generic / hybrid / biosimilar product","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-05-24T11:20:00Z","last_updated_date":"2018-06-27T15:31:00Z","reference_number":"EMA/627621/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-general-principles-regarding-summary-product-characteristics-information-generic-hybrid-biosimilar-product_en.pdf"},
    {"id":"36025","name":"Agenda - Workshop on development of antimycobacterial medicinal products (to treat Mycobacterium tuberculosis)","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/427839/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-development-antimycobacterial-medicinal-products-treat-mycobacterium-tuberculosis_en.pdf"},
    {"id":"36028","name":"Poliovirus type 1 / poliovirus type 2 / poliovirus type 3 vaccine (oral, live, attenuated): List of nationally authorised medicinal products - PSUSA/00002458/201607","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-14T17:30:00Z","last_updated_date":"2017-03-14T17:38:00Z","reference_number":"EMA/174474/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/poliovirus-type-1-poliovirus-type-2-poliovirus-type-3-vaccine-oral-live-attenuated-list-nationally-authorised-medicinal-products-psusa00002458201607_en.pdf"},
    {"id":"36029","name":"Rules of engagement and procedures for participating authorities (active pharmaceutical ingredients / active substances)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-07T01:00:00Z","last_updated_date":"2009-01-07T01:00:00Z","reference_number":"EMEA/INS/GMP/414323/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/rules-engagement-and-procedures-participating-authorities-active-pharmaceutical-ingredients-active-substances_en.pdf"},
    {"id":"36030","name":"Presentation - Cell-based medicinal products for global market: Food and Drug Administration perspectives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cell-based-medicinal-products-global-market-food-and-drug-administration-perspectives_en.pdf"},
    {"id":"36031","name":"Guidelines and concept papers adopted during the CHMP meeting 22-25 June 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-07-02T12:15:00Z","last_updated_date":"2015-07-02T12:15:00Z","reference_number":"EMA/28019/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-22-25-june-2015_en.pdf"},
    {"id":"36032","name":"CHMP summary of positive opinion for Olumiant","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-olumiant_en.pdf"},
    {"id":"36033","name":"Committee for medicinal products for veterinary use summary of opinion: Zactran: International Non-proprietary Names (INN): Gamithromycin","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-05-16T03:09:21Z","last_updated_date":"2008-05-16T03:09:21Z","reference_number":"EMEA/CVMP/220772/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-zactran-international-non-proprietary-names-inn-gamithromycin_en.pdf"},
    {"id":"36034","name":"Kogenate Bayer and Helixate NexGen Article-20 procedure - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-09T12:00:00Z","last_updated_date":"2014-04-09T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kogenate-bayer-and-helixate-nexgen-article-20-procedure-annex-iv_sv.pdf"}},
    {"id":"36035","name":"Points to consider regarding efficacy requirements for minor species and minor indications","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2002-02-14T01:00:00Z","last_updated_date":"2002-02-14T01:00:00Z","reference_number":"EMEA/CVMP/610/01-Consultation","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-regarding-efficacy-requirements-minor-species-and-minor-indications_en.pdf"},
    {"id":"36037","name":"CHMP summary of positive opinion for Mektovi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/476013/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mektovi_en.pdf"},
    {"id":"36040","name":"Start of community reviews - CHMP meeting of 19-22 January 2015","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T13:00:00Z","last_updated_date":"2015-01-23T13:00:00Z","reference_number":"EMA/388940/2014","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-19-22-january-2015_en.pdf"},
    {"id":"36042","name":"Presentation - Pharmacogenomics: a long(er) learning curve?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacogenomics-longer-learning-curve_en.pdf"},
    {"id":"36044","name":"Template for submission of comments for standard lists for EudraVigilance Veterinary (EVVet)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-07-19T02:00:00Z","last_updated_date":"2013-06-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-submission-comments-standard-lists-eudravigilance-veterinary-evvet_en.doc"},
    {"id":"36045","name":"Neurontin - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-09-06T02:08:21Z","last_updated_date":"2006-09-06T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/neurontin-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"36046","name":"Programme of the EMA-FDA-Health Canada workshop on paediatric pulmonary arterial hypertension (PAH)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-06-06T12:49:00Z","last_updated_date":"2017-06-20T12:49:00Z","reference_number":"EMA/848554/2016 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-ema-fda-health-canada-workshop-paediatric-pulmonary-arterial-hypertension-pah_en.pdf"},
    {"id":"36047","name":"Presentation - European Medicines Agency communication strategy: Strategic planning for the future and vision for veterinary medicines (Marie-Agnes Heine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-communication-strategy-strategic-planning-future-and-vision-veterinary-medicines-marie-agnes-heine_en.pdf"},
    {"id":"36049","name":"Opinion of the HMPC on a European Union herbal monograph on Centaurium erythraea Rafn. s.l., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"EMA/HMPC/642018/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-centaurium-erythraea-rafn-sl-herba_en.pdf"},
    {"id":"36050","name":"Committee for Advanced Therapies (CAT): October 2010 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-10-28T02:00:00Z","last_updated_date":"2010-10-28T02:00:00Z","reference_number":"EMA/CAT/657770/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-october-2010-meeting-monthly-report_en.pdf"},
    {"id":"36051","name":"Draft assessment report on Ribes nigrum L., folium","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T10:25:00Z","last_updated_date":"2017-02-28T10:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-ribes-nigrum-l-folium_en.pdf"},
    {"id":"36054","name":"Committee for Advanced Therapies (CAT): October 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-10-25T17:18:00Z","last_updated_date":"2011-10-25T17:30:00Z","reference_number":"EMA/CAT/850481/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-october-2011-meeting-monthly-report_en.pdf"},
    {"id":"36055","name":"COMP work plan 2020","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2020-03-09T16:30:00Z","last_updated_date":"2020-03-09T16:30:00Z","reference_number":"EMA/COMP/478696/2019","document_url":"https://www.ema.europa.eu/en/documents/work-programme/comp-work-plan-2020_en.pdf"},
    {"id":"36056","name":"Questions and answers on the suspension of rosiglitazone-containing medicines (Avandia, Avandamet and Avaglim)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-09-23T02:00:00Z","last_updated_date":"2010-09-23T02:00:00Z","reference_number":"EMA/CHMP/586211/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-suspension-rosiglitazone-containing-medicines-avandia-avandamet-and-avaglim_en.pdf"},
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    {"id":"36058","name":"First medicine to treat neonatal diabetes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-02-23T13:01:00Z","last_updated_date":"2018-02-23T13:01:00Z","reference_number":"EMA/CHMP/110433/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-medicine-treat-neonatal-diabetes_en.pdf"},
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    {"id":"36061","name":"Scientific recommendation on classification of advanced therapy medicinal products: cryopreserved allogeneic hematopoietic progenitor cells (HPC–CD34+) accompanied by facilitating cells (FC– CD8+/TCR-) and T cells, prepa...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-19T15:30:00Z","last_updated_date":"2016-04-19T15:30:00Z","reference_number":"EMA/263760/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cryopreserved-allogeneic-hematopoietic-progenitor-cells-hpc-cd34-accompanied-facilitating-cells-fc-cd8tcr-and-t-cells-prepa_en.pdf"},
    {"id":"36065","name":"Herbal medicinal products working group executive summary of AD HOC meetings","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-01-28T01:00:00Z","last_updated_date":"1997-01-28T01:00:00Z","reference_number":"EMEA/1120/97 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/herbal-medicinal-products-working-group-executive-summary-ad-hoc-meetings_en.pdf"},
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    {"id":"36099","name":"Withdrawal assessment report for SecreFlo","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/482305/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-secreflo_en.pdf"},
    {"id":"36103","name":"EU/3/16/1762: Public summary of positive opinion for orphan designation of synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker for the treatment of paroxysmal nocturnal hae...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2022-02-01T01:00:00Z","reference_number":"EMA/620104/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161762-public-summary-positive-opinion-orphan-designation-synthetic-15-amino-acid-macrocyclic-peptide-acylated-polyethyleneglycol-palmitoylated-linker-treatment-paroxysmal-nocturnal-hae_en.pdf"},
    {"id":"36106","name":"Closing report on assessment of a supply shortage of a medicinal product due to manufacturing and quality problems.","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-29T00:00:00Z","last_updated_date":"2013-01-29T00:00:00Z","reference_number":"EMA/443443/2013","document_url":"https://www.ema.europa.eu/en/documents/other/closing-report-assessment-supply-shortage-medicinal-product-due-manufacturing-and-quality-problems_en.pdf"},
    {"id":"36107","name":"Bradley Malin (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/bradley-malin-doi_en.pdf"},
    {"id":"36109","name":"17th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-11-05T00:00:00Z","last_updated_date":"2001-11-05T00:00:00Z","reference_number":"EMEA/COMP/498/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/17th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"36111","name":"EU/3/12/981: Public summary of opinion on orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene for the treatment of Leber’s congenital amaurosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-04-30T02:00:00Z","reference_number":"EMA/COMP/142986/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312981-public-summary-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-2-containing-human-rpe65-gene-treatment-lebers-congenital-amaurosis_en.pdf"},
    {"id":"36112","name":"Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (P. Bahri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-european-union-eu-gvp-p-bahri-ema_en.pdf"},
    {"id":"36115","name":"Responsible use of veterinary antimicrobials in the UK - John FitzGerald","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:09:21Z","last_updated_date":"2009-05-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/responsible-use-veterinary-antimicrobials-uk-john-fitzgerald_en.pdf"},
    {"id":"36116","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 17-19 August 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-09-01T12:00:00Z","last_updated_date":"2016-09-01T12:00:00Z","reference_number":"EMA/PDCO/567509/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-17-19-august-2016_en.pdf"},
    {"id":"36117","name":"Overview of comments received on the guideline on the approach to establish a pharmacological acceptable daily intake","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-19T11:30:00Z","last_updated_date":"2012-11-19T11:30:00Z","reference_number":"EMA/CVMP/SWP/634672/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-approach-establish-pharmacological-acceptable-daily-intake_en.pdf"},
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    {"id":"36123","name":"Presentation - Industry perspective on partnering with academia and agencies in drug development for children with PAH (J. Strait, Merck Sharp & Dohme)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-partnering-academia-and-agencies-drug-development-children-pah-j-strait-merck-sharp-dohme_en.pdf"},
    {"id":"36125","name":"CHMP summary of positive opinion for Duloxetine Lilly","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/CHMP/605915/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-duloxetine-lilly_en.pdf"},
    {"id":"36129","name":"Presentation - US Regulators perspective, Russell Katz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-us-regulators-perspective-russell-katz_en.pdf"},
    {"id":"36132","name":"Withdrawal assessment report for Insulin Human Rapid Marvel","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/CHMP/317778/2007","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-insulin-human-rapid-marvel_en.pdf"},
    {"id":"36134","name":"Guideline on the Core SPC for human plasma derived Hepatitis-B immunoglobulin for intravenous use (CPMP/BPWG/4027/02)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-04-27T02:00:00Z","last_updated_date":"2006-04-27T02:00:00Z","reference_number":"CPMP/BPWG/4027/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-plasma-derived-hepatitis-b-immunoglobulin-intravenous-use-cpmpbpwg402702_en.pdf"},
    {"id":"36138","name":"EU/3/10/743: Public summary of positive opinion for Pagibaximab for the prevention of sepsis caused by Gram-positive pathogens in premature infants less than or equal to 34 weeks of gestational age","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2012-02-02T12:09:00Z","reference_number":"EMA/COMP/164788/2010 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310743-public-summary-positive-opinion-pagibaximab-prevention-sepsis-caused-gram-positive-pathogens-premature-infants-less-or-equal-34-weeks-gestational-age_en.pdf"},
    {"id":"36139","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous bone marrow cell aspirate in autologous plasma","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-06-04T19:00:00Z","last_updated_date":"2014-06-04T19:00:00Z","reference_number":"EMA/326911/2014","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-cell-aspirate-autologous-plasma_en.pdf"},
    {"id":"36140","name":"Note for guidance: Harmonisation of requirements for equine influenza vaccines: Specific requirements for substitution or addition of a strain or strains","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-11-01T01:00:00Z","last_updated_date":"1998-11-01T01:00:00Z","reference_number":"EMEA/CVMP/112/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-harmonisation-requirements-equine-influenza-vaccines-specific-requirements-substitution-or-addition-strain-or-strains_en.pdf"},
    {"id":"36141","name":"Final assessment report on Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et Arn., Grindelia camporum Greene, herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-03-11T11:00:00Z","last_updated_date":"2013-03-11T11:00:00Z","reference_number":"EMA/HMPC/748218/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-grindelia-robusta-nutt-grindelia-squarrosa-pursh-dunal-grindelia-humilis-hook-et-arn-grindelia-camporum-greene-herba_en.pdf"},
    {"id":"36142","name":"Estradiol (17-beta) / trimegestone: List of nationally authorised medicinal products - PSUSA/00001275/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-07T18:20:00Z","last_updated_date":"2017-12-07T18:20:00Z","reference_number":"EMA/811732/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/estradiol-17-beta-trimegestone-list-nationally-authorised-medicinal-products-psusa00001275201703_en.pdf"},
    {"id":"36143","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 19-22 October 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-10-30T15:45:00Z","last_updated_date":"2015-10-30T15:45:00Z","reference_number":"EMA/38688/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-19-22-october-2015_en.pdf"},
    {"id":"36145","name":"Overview of comments received on draft guideline on similar biological medicinal products containing low-molecular-weight-herapins","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-11-18T00:09:21Z","last_updated_date":"2009-11-18T00:09:21Z","reference_number":"EMEA/582443/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-similar-biological-medicinal-products-containing-low-molecular-weight-herapins_en.pdf"},
    {"id":"36146","name":"Numeta Article-107i procedure - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-09-27T15:00:00Z","last_updated_date":"2013-09-27T15:00:00Z","reference_number":"EMA/587344/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-prac-assessment-report_en.pdf"},
    {"id":"36147","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-01-12T17:00:00Z","last_updated_date":"2017-01-12T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course_en.pdf-1"},
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    {"id":"36151","name":"Veterinary Scientific Advice Workshop - Registration form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-05-07T02:09:21Z","last_updated_date":"2008-05-07T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/veterinary-scientific-advice-workshop-registration-form_en.pdf"},
    {"id":"36153","name":"Leflunomide Actavis Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/leflunomide-actavis-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"36155","name":"Public statement on Duloxetine Boehringer Ingelheim (duloxetine): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2010-06-21T02:00:00Z","last_updated_date":"2010-06-21T02:00:00Z","reference_number":"EMA/168057/2010","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-duloxetine-boehringer-ingelheim-duloxetine-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"36160","name":"Presentation - Implementing ISO ICSR-ICH E2B(R3): Submodule b - backwards and forwards conversion","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-10-12T16:00:00Z","last_updated_date":"2016-10-12T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementing-iso-icsr-ich-e2br3-submodule-b-backwards-and-forwards-conversion_en.pdf"},
    {"id":"36162","name":"ICH: Q 1 F: Stability data package for registration in climatic zones III and IV","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"CPMP/ICH/421/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-f-stability-data-package-registration-climatic-zones-iii-and-iv_en.pdf"},
    {"id":"36163","name":"CHMP post-authorisation summary of positive opinion for Eylea","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/CHMP/185823/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-eylea_en.pdf-2"},
    {"id":"36164","name":"VICH GL46: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-04-07T02:00:00Z","last_updated_date":"2011-04-07T02:00:00Z","reference_number":"EMA/CVMP/VICH/463072/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl46-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-animals-metabolism-study-determine-quantity-and-identify-nature-residues_en.pdf"},
    {"id":"36165","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured allogenic Wharton’s jelly derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/417124/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-allogenic-whartons-jelly-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"36168","name":"Ruta graveolens: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-03-01T01:00:00Z","last_updated_date":"1999-03-01T01:00:00Z","reference_number":"EMEA/MRL/542/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ruta-graveolens-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36170","name":"EU/3/12/1013: Public summary of opinion on orphan designation: Recombinant human interleukin-7 for the treatment of progressive multifocal leukoencephalopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2014-07-14T16:00:00Z","reference_number":"EMA/COMP/383327/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121013-public-summary-opinion-orphan-designation-recombinant-human-interleukin-7-treatment-progressive-multifocal-leukoencephalopathy_en.pdf"},
    {"id":"36173","name":"Agenda - Second industry stakeholder platform on the operation of the centralised procedure for human medicinal products","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-11-12T14:00:01Z","last_updated_date":"2015-11-12T14:00:01Z","reference_number":"EMA/633298/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-industry-stakeholder-platform-operation-centralised-procedure-human-medicinal-products_en.pdf"},
    {"id":"36175","name":"EU/3/03/177: Public summary of positive opinion for orphan designation of 3-(4'aminoisoindoline-1'-one)-1-piperidine-2,6-dione for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMEA/COMP/388/2004 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303177-public-summary-positive-opinion-orphan-designation-3-4aminoisoindoline-1-one-1-piperidine-26-dione-treatment-multiple-myeloma_en.pdf"},
    {"id":"36176","name":"Public statement on Tamiflu IV - Closure of compassionate-use programme in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-08-30T17:52:00Z","last_updated_date":"2013-08-30T17:52:00Z","reference_number":"EMA/480494/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-tamiflu-iv-closure-compassionate-use-programme-european-union_en.pdf"},
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    {"id":"36182","name":"Opinion of the CVMP on the establishment of maximum residue limits: Manganese carbonate","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-11-27T15:45:00Z","last_updated_date":"2013-11-27T15:45:00Z","reference_number":"EMA/CVMP/14468/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-manganese-carbonate_en.pdf"},
    {"id":"36184","name":"Chemistry of active substances - Superseded document","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-10-01T02:00:00Z","last_updated_date":"2015-10-01T02:00:00Z","reference_number":"3AQ5A","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/chemistry-active-substances-superseded-document_en.pdf"},
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    {"id":"36192","name":"CHMP post-authorisation summary of positive opinion for Eucreas","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/600949/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-eucreas_en.pdf"},
    {"id":"36193","name":"CVMP post-authorisation summary of positive opinion for Stronghold","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2015-01-16T01:00:00Z","reference_number":"EMA/737305/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-stronghold_en.pdf"},
    {"id":"36194","name":"Guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-06-10T13:30:00Z","last_updated_date":"2015-06-10T13:30:00Z","reference_number":"CPMP/EWP/2986/03 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure-revision-1_en.pdf"},
    {"id":"36196","name":"Withdrawal assessment report for Zemfirza","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-12-21T01:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"EMA/CHMP/616303/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zemfirza_en.pdf"},
    {"id":"36197","name":"EU/3/05/345: Public summary of positive opinion for orphan designation of lentiviral vector containing the human Wiskott Aldrich syndrome protein gene for the treatment of Wiskott Aldrich syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2014-06-19T02:00:00Z","reference_number":"EMEA/COMP/24267/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305345-public-summary-positive-opinion-orphan-designation-lentiviral-vector-containing-human-wiskott-aldrich-syndrome-protein-gene-treatment-wiskott-aldrich-syndrome_en.pdf"},
    {"id":"36198","name":"Presentation - Session 5.1: Pharmacovigilance: What data / studies could be deferred to the post-authorisation phase?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:51Z","last_updated_date":"2012-06-15T17:10:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-51-pharmacovigilance-what-data-studies-could-be-deferred-post-authorisation-phase_en.pdf"},
    {"id":"36199","name":"Form 2: For marketing-authorisation holders when submitting corrected translation to the national competent authority of Croatia","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/form-2-marketing-authorisation-holders-when-submitting-corrected-translation-national-competent-authority-croatia_en.doc"},
    {"id":"36201","name":"Letter of support for drug-induced vascular injury (DIVI) biomarker","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-09T15:15:00Z","last_updated_date":"2017-11-09T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-drug-induced-vascular-injury-divi-biomarker_en.pdf"},
    {"id":"36202","name":"Virus Shedding - David Eckland","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/virus-shedding-david-eckland_en.pdf"},
    {"id":"36209","name":"Valproate Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-03-10T13:00:00Z","last_updated_date":"2017-03-10T13:00:00Z","reference_number":"EMA/PRAC/154222/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/valproate-article-31-referral-prac-list-questions_en.pdf"},
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    {"id":"36215","name":"Omega-3 acid ethyl esters - List of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2018-03-23T13:00:00Z","reference_number":"EMEA/H/A-31/1464","document_url":"https://www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-list-questions_en.pdf"},
    {"id":"36216","name":"Guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-21T11:30:00Z","last_updated_date":"2012-06-21T11:30:00Z","reference_number":"EMA/CHMP/BPWP/1625/1999 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-human-plasma-derived-and-recombinant-coagulation-factor-ix-products-revision-1_en.pdf"},
    {"id":"36217","name":"Presentation - The patient-advocate view (Yann Le Cam)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-26T01:00:00Z","last_updated_date":"2013-11-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-advocate-view-yann-le-cam_en.pdf"},
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    {"id":"36224","name":"Actelion withdraws its application for an extension of indication for Zavesca","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-02-25T00:09:21Z","last_updated_date":"2008-02-25T00:09:21Z","reference_number":"EMEA/95140/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/actelion-withdraws-its-application-extension-indication-zavesca_en.pdf"},
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    {"id":"36226","name":"Questions and answers on Gutal 1000 g/kg premix for medicated feeding stuff for piglets (zinc oxide)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-11-26T01:00:00Z","last_updated_date":"2015-11-26T01:00:00Z","reference_number":"EMA/709250/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-gutal-1000-gkg-premix-medicated-feeding-stuff-piglets-zinc-oxide_sv.pdf"}},
    {"id":"36228","name":"Presentation - Endpoints and their relevance to older people: cancer and palliative care and the work of the European Organization for Research and Treatment of Cancer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-endpoints-and-their-relevance-older-people-cancer-and-palliative-care-and-work-european-organization-research-and-treatment-cancer_en.pdf"},
    {"id":"36229","name":"Overview of comments received on Community herbal monograph on Thymus vulgaris L., Thymus zygis Loefl. ex. L., aetheroleum - Superseded","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/638578/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-thymus-vulgaris-l-thymus-zygis-loefl-ex-l-aetheroleum-superseded_en.pdf"},
    {"id":"36231","name":"Clobutinol - Article 107 procedures - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-10-19T02:08:21Z","last_updated_date":"2007-10-19T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/clobutinol-article-107-procedures-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/clobutinol-article-107-procedures-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/clobutinol-article-107-procedures-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/clobutinol-article-107-procedures-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/clobutinol-article-107-procedures-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/clobutinol-article-107-procedures-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/clobutinol-article-107-procedures-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/clobutinol-article-107-procedures-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/clobutinol-article-107-procedures-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/clobutinol-article-107-procedures-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/clobutinol-article-107-procedures-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/clobutinol-article-107-procedures-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/clobutinol-article-107-procedures-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/clobutinol-article-107-procedures-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/clobutinol-article-107-procedures-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/clobutinol-article-107-procedures-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/clobutinol-article-107-procedures-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/clobutinol-article-107-procedures-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/clobutinol-article-107-procedures-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/clobutinol-article-107-procedures-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/clobutinol-article-107-procedures-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/clobutinol-article-107-procedures-annex-ii_sv.pdf"}},
    {"id":"36232","name":"CVMP summary of positive opinion for Cepedex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-10-07T17:00:00Z","last_updated_date":"2016-10-07T17:00:00Z","reference_number":"EMA/CVMP/623365/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-cepedex_en.pdf"},
    {"id":"36236","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n17-20 September 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-09-21T02:09:21Z","last_updated_date":"2007-09-21T02:09:21Z","reference_number":"EMEA/323703/2007 - corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-17-20-september-2007_en.pdf"},
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    {"id":"36238","name":"Fluticasone propionate / formoterol fumarate dihydrate: List of nationally authorised medicinal products - PSUSA/00010339/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-22T17:00:00Z","last_updated_date":"2018-03-22T17:00:00Z","reference_number":"EMA/182904/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluticasone-propionate-formoterol-fumarate-dihydrate-list-nationally-authorised-medicinal-products-psusa00010339201707_en.pdf"},
    {"id":"36242","name":"Dossier requirements for centrally authorised products","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-06-26T02:00:00Z","last_updated_date":"2021-01-06T11:00:00Z","reference_number":"EMA/497021/2012 Rev. 26","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/dossier-requirements-centrally-authorised-products_en.pdf"},
    {"id":"36243","name":"Presentation - 2012 addendum to the EU guideline on antibacterial agents (Mair Powell)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2012-addendum-eu-guideline-antibacterial-agents-mair-powell_en.pdf"},
    {"id":"36244","name":"Presentation - 1.1 The Asterix project: overview (Kit Roes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11-asterix-project-overview-kit-roes_en.pdf"},
    {"id":"36245","name":"Participants list – 6th industry stakeholder platform - operation of EU pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"EMA/48691/2016","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-6th-industry-stakeholder-platform-operation-eu-pharmacovigilance-legislation_en.pdf"},
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    {"id":"36272","name":"Meeting highlights from the Paediatric Committee: 2 - 4 July 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/PDCO/355329/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-2-4-july-2008_en.pdf"},
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    {"id":"36276","name":"Letter to the International Federation for Animal Health Europe regarding its request for fee waivers for centralised applications of inactivated bluetongue vaccines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-03-04T00:09:21Z","last_updated_date":"2008-03-04T00:09:21Z","reference_number":"EMEA/111981/2008","document_url":"https://www.ema.europa.eu/en/documents/other/letter-international-federation-animal-health-europe-regarding-its-request-fee-waivers-centralised-applications-inactivated-bluetongue-vaccines_en.pdf"},
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    {"id":"36280","name":"Draft assessment report on Glycine max (L.) Merr., semen - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2017-02-28T01:00:00Z","last_updated_date":"2017-02-28T01:00:00Z","reference_number":"EMA/HMPC/461813/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-glycine-max-l-merr-semen-first-version_en.pdf"},
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    {"id":"36296","name":"Note for guidance: Excipients in the dossier for application for marketing authorisation for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-02-01T01:00:00Z","last_updated_date":"1999-02-01T01:00:00Z","reference_number":"EMEA/CVMP/004/98 - FINAL","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-excipients-dossier-application-marketing-authorisation-veterinary-medicinal-products_en.pdf"},
    {"id":"36297","name":"Glycopyrronium / neostigmine: CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001557/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-07T02:00:00Z","last_updated_date":"2016-10-17T15:59:50Z","reference_number":"EMA/471859/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/glycopyrronium-neostigmine-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001557201509_en.pdf"},
    {"id":"36300","name":"Presentation - Update on Working Group 9 (Mark Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-working-group-9-mark-turner_en.pdf"},
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    {"id":"36374","name":"EMEA recommends new warnings and contraindications for rosiglitazone","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-01-24T00:09:21Z","last_updated_date":"2008-01-24T00:09:21Z","reference_number":"EMEA/42232/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-recommends-new-warnings-and-contraindications-rosiglitazone_en.pdf"},
    {"id":"36379","name":"Industry Activities on Collection of Data on Volume (Sales) of Antimicrobials and Proposals for the Future - Ludwig Klostermann","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/industry-activities-collection-data-volume-sales-antimicrobials-and-proposals-future-ludwig-klostermann_en.pdf"},
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    {"id":"36404","name":"Draft assessment report on Vitex agnus-castus L., fructus - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2009-09-17T02:09:00Z","last_updated_date":"2009-09-17T02:09:00Z","reference_number":"EMEA/HMPC/144003/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-vitex-agnus-castus-l-fructus-first-version_en.pdf"},
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    {"id":"36421","name":"Presentation - Optimising resources: Incentives for academia, hospital and charities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T12:00:00Z","last_updated_date":"2012-02-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optimising-resources-incentives-academia-hospital-and-charities_en.pdf"},
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    {"id":"36424","name":"2011 EudraVigilance Human annual report - Explanatory note","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-06-19T11:29:00Z","last_updated_date":"2013-06-19T11:29:00Z","reference_number":"EMA/476834/2012","document_url":"https://www.ema.europa.eu/en/documents/other/2011-eudravigilance-human-annual-report-explanatory-note_en.pdf"},
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    {"id":"36429","name":"Homoeopathy and European Pharmacopoeia: current status and future development - Isabelle Mercier","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/homoeopathy-and-european-pharmacopoeia-current-status-and-future-development-isabelle-mercier_en.pdf"},
    {"id":"36431","name":"Superseded final opinion of the HMPC on a Community herbal monograph on Thymus vulgaris L., Thymus zygis L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"EMEA/HMPC/453713/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-final-opinion-hmpc-community-herbal-monograph-thymus-vulgaris-l-thymus-zygis-l-herba_en.pdf"},
    {"id":"36432","name":"Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-05T12:10:00Z","last_updated_date":"2017-10-05T12:10:00Z","reference_number":"EMA/658449/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/olodaterol-list-nationally-authorised-medicinal-products-psusa00010245201703_en.pdf"},
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    {"id":"36438","name":"EU/3/17/1938: Public summary of opinion on orphan designation: Antisense oligonucleotide targeting exon 73 in the COL7A1 gene for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/690435/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171938-public-summary-opinion-orphan-designation-antisense-oligonucleotide-targeting-exon-73-col7a1-gene-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"36440","name":"Presentation - Quality of pharmaceutical veterinary medicines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-pharmaceutical-veterinary-medicines_en.pdf"},
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    {"id":"36443","name":"Recommendation to marketing authorisation holders, highlighting recent measures in the veterinary field to promote reduction, refinement and replacement (3Rs) measures described in the European Pharmacopoeia - Applicable...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-01-24T16:30:00Z","last_updated_date":"2018-02-16T11:00:00Z","reference_number":"EMA/CVMP/3Rs/336802/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-marketing-authorisation-holders-highlighting-recent-measures-veterinary-field-promote-reduction-refinement-and-replacement-3rs-measures-described-european-pharmacopoeia-applicable_en.pdf"},
    {"id":"36446","name":"Ad hoc working group on Herbal Medicinal Products: Note for guidance on fixed combinations of Herbal Medicinal Products with long-term marketing experience - Guidance to facilitate mutual recognition and Uue of bibliogra...","type":"other","status":"unknown","consultation_date":"","first_published_date":"1999-01-28T01:00:00Z","last_updated_date":"1999-01-28T01:00:00Z","reference_number":"EMEA/HMPWP/15/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-group-herbal-medicinal-products-note-guidance-fixed-combinations-herbal-medicinal-products-long-term-marketing-experience-guidance-facilitate-mutual-recognition-and-uue-bibliogra_en.pdf"},
    {"id":"36452","name":"EU/3/02/129: Public summary of positive opinion for orphan designation of\n\nG17(9) gastrin-diphtheria toxoid conjugate for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2009-09-21T02:00:00Z","reference_number":"EMEA/COMP/2393/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302129-public-summary-positive-opinion-orphan-designation-g179-gastrin-diphtheria-toxoid-conjugate-treatment-pancreatic-cancer_en.pdf"},
    {"id":"36456","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 12-15 March 2012","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T13:01:00Z","last_updated_date":"2012-03-16T13:01:00Z","reference_number":"EMA/CHMP/SAWP/184762/2012","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-12-15-march-2012_en.pdf"},
    {"id":"36458","name":"Questions and answers on the follow-up to the Viracept recall","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-06-21T02:00:00Z","last_updated_date":"2007-06-21T02:00:00Z","reference_number":"EMEA/276379/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-follow-viracept-recall_en.pdf"},
    {"id":"36463","name":"CHMP post-authorisation summary of positive opinion for Aclasta on 24 July 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/391587/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-aclasta-24-july-2008_en.pdf"},
    {"id":"36467","name":"Guiding principles for international pharmacovigilance cluster","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-14T16:00:00Z","last_updated_date":"2015-07-14T16:00:00Z","reference_number":"EMA/443343/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guiding-principles-international-pharmacovigilance-cluster_en.pdf"},
    {"id":"36468","name":"Draft assessment report on Agropyron repens (L.) P. Beauv., rhizoma","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-03-15T01:00:00Z","last_updated_date":"2011-03-15T01:00:00Z","reference_number":"EMA/HMPC/563395/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-agropyron-repens-l-p-beauv-rhizoma_en.pdf"},
    {"id":"36471","name":"Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Bromelain","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-02-02T09:50:00Z","last_updated_date":"2018-02-02T09:50:00Z","reference_number":"EMA/CVMP/255492/2017","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits-bromelain_en.pdf"},
    {"id":"36473","name":"Gamithromycin (porcine): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-02-24T12:00:00Z","last_updated_date":"2015-02-24T12:00:00Z","reference_number":"EMA/CVMP/350415/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gamithromycin-porcine-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"36476","name":"Note for guidance on quality of water for pharmaceutical use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-05-01T02:00:00Z","last_updated_date":"2002-05-01T02:00:00Z","reference_number":"CPMP/QWP/158/01 Revision","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-quality-water-pharmaceutical-use_en.pdf"},
    {"id":"36477","name":"Presentation - Working group on dialogue and interaction with Ethics Committees (Allison Needham, Pirkko Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-dialogue-and-interaction-ethics-committees-allison-needham-pirkko-lepola_en.pdf"},
    {"id":"36480","name":"Certification evaluation report","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-12-17T15:50:00Z","last_updated_date":"2014-12-17T15:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/certification-evaluation-report_en.doc"},
    {"id":"36482","name":"EU/3/07/475: Public summary of positive opinion for orphan designation of alginate oligosaccharide (G-block) fragment for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2009-09-17T02:00:00Z","reference_number":"EMEA/COMP/164923/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307475-public-summary-positive-opinion-orphan-designation-alginate-oligosaccharide-g-block-fragment-treatment-cystic-fibrosis_en.pdf"},
    {"id":"36483","name":"First DNA vaccine in the EU recommended for use in salmon","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/CVMP/281226/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-dna-vaccine-eu-recommended-use-salmon_en.pdf"},
    {"id":"36485","name":"Overview of comments received on guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMEA/CVMP/016/00-Rev.2-CONSULTATION) - Revision 2","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-04-20T02:00:00Z","last_updated_date":"2011-04-20T02:00:00Z","reference_number":"EMA/CVMP/676396/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-emeacvmp01600-rev2-consultation-revision-2_en.pdf"},
    {"id":"36486","name":"Letter of support for micro-aneurysm formation rate (MAFR) biomarker","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-21T12:00:00Z","last_updated_date":"2015-01-21T12:00:00Z","reference_number":"EMA/775397/2014","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-micro-aneurysm-formation-rate-mafr-biomarker_en.pdf"},
    {"id":"36488","name":"Rhei radix: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-11-01T01:00:00Z","last_updated_date":"1999-11-01T01:00:00Z","reference_number":"EMEA/MRL/648/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/rhei-radix-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36489","name":"Agenda - Programme of the 2015 European Union Good-clinical-practice Inspectors Working Group workshop on 12-14 October","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-10-09T14:30:00Z","last_updated_date":"2015-10-09T14:30:00Z","reference_number":"EMA/104761/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-2015-european-union-good-clinical-practice-inspectors-working-group-workshop-12-14-october_en.pdf"},
    {"id":"36490","name":"Agenda - European Medicines Agency and Medicines for Europe annual bilateral meeting 2017","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-01-13T01:00:00Z","last_updated_date":"2017-01-13T01:00:00Z","reference_number":"EMA/2341/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-and-medicines-europe-annual-bilateral-meeting-2017_en.pdf"},
    {"id":"36491","name":"Tulathromycin (modification of the microbiological ADI and MRLs in bovine and porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-02-10T18:10:00Z","last_updated_date":"2015-02-10T18:10:00Z","reference_number":"EMA/CVMP/598235/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tulathromycin-modification-microbiological-adi-and-mrls-bovine-and-porcine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"36493","name":"Draft list of references for assessment of Meliloti herba Melilotus officinalis (L.) Lam. (melilot)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-10-31T01:00:00Z","last_updated_date":"2007-10-31T01:00:00Z","reference_number":"EMEA/HMPC/476396/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-meliloti-herba-melilotus-officinalis-l-lam-melilot_en.pdf"},
    {"id":"36494","name":"Folic acid: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-09-01T02:00:00Z","last_updated_date":"1997-09-01T02:00:00Z","reference_number":"EMEA/MRL/262/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/folic-acid-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36495","name":"EU/3/16/1609: Public summary of opinion on orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s for the treatment of autoimmune haemolytic anaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2016-04-06T02:00:00Z","reference_number":"EMA/COMP/68353/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161609-public-summary-opinion-orphan-designation-humanised-igg4-monoclonal-antibody-against-total-complement-component-1-subcomponent-s-treatment-autoimmune-haemolytic-anaemia_en.pdf"},
    {"id":"36496","name":"Overview of comments on 'Vortioxetine hydrobromide immediate release tablets 5 mg, 10 mg, 15 mg, and 20 mg; vortioxetine lactate oral drops solution 20 mg/ml product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"EMA/CHMP/260596/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-vortioxetine-hydrobromide-immediate-release-tablets-5-mg-10-mg-15-mg-and-20-mg-vortioxetine-lactate-oral-drops-solution-20-mgml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"36497","name":"Standard operating procedure for re-evaluation and financial re-assessment procedures for eligible patients', consumers' and healthcare professionals’ organisations","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2013-02-04T11:20:00Z","last_updated_date":"2015-03-17T11:10:00Z","reference_number":"SOP/H/3417","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-re-evaluation-and-financial-re-assessment-procedures-eligible-patients-consumers-and-healthcare-professionals-organisations_en.pdf"},
    {"id":"36498","name":"Dexamed and associated names Article-29(4) referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-02T02:00:00Z","last_updated_date":"2014-09-02T02:00:00Z","reference_number":"EMA/353952/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/dexamed-and-associated-names-article-294-referral-assessment-report_en.pdf"},
    {"id":"36499","name":"Withdrawal letter : DepoCyte","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-06-28T02:00:00Z","last_updated_date":"2006-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-depocyte_en.pdf"},
    {"id":"36500","name":"Abamectin (Extension to sheep): Summary Report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/692/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/abamectin-extension-sheep-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36501","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 19 - 22 October 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T14:00:00Z","last_updated_date":"2015-10-23T14:00:00Z","reference_number":"EMA/CHMP/SAWP/701884/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-19-22-october-2015_en.pdf"},
    {"id":"36504","name":"Public statement on Docetaxel Mylan: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-03-19T01:00:00Z","last_updated_date":"2015-06-29T20:00:00Z","reference_number":"EMEA/H/C/002317 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-docetaxel-mylan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"36509","name":"Announcement for the NRG position paper re-use of invented names of medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"EMA/51157/2011","document_url":"https://www.ema.europa.eu/en/documents/other/announcement-nrg-position-paper-re-use-invented-names-medicinal-products_en.pdf"},
    {"id":"36510","name":"Scientific recommendation on classification of advanced therapy medicinal products: Killed spores of Bacillus subtilis incorporating a non-toxic antigen of Clostridium difficile","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T17:00:00Z","last_updated_date":"2015-03-02T17:00:00Z","reference_number":"EMA/590710/2014","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-killed-spores-bacillus-subtilis-incorporating-non-toxic-antigen-clostridium-difficile_en.pdf"},
    {"id":"36512","name":"Diclofenac (2) Bovine milk - European Public MRL Assessment Report (EPMAR) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/CVMP/67421/2009","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diclofenac-2-bovine-milk-european-public-mrl-assessment-report-epmar-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36513","name":"Presentation - PENTA-ID - The future (Mike Sharland)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-penta-id-future-mike-sharland_en.pdf"},
    {"id":"36516","name":"Presentation - Methods to manage risk in a placebo trial (Susan VanMeter, Sarah Kavanagh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-methods-manage-risk-placebo-trial-susan-vanmeter-sarah-kavanagh_en.pdf"},
    {"id":"36518","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - November 2007","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-11-30T00:00:00Z","last_updated_date":"2007-11-30T00:00:00Z","reference_number":"EMEA/571778/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-november-2007_en.pdf"},
    {"id":"36519","name":"CHMP post-authorisation summary of positive opinion for SonoVue","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T17:53:00Z","last_updated_date":"2017-06-23T17:53:00Z","reference_number":"EMA/CHMP/347620/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sonovue_en.pdf"},
    {"id":"36520","name":"Presentation - Predictors of outcome and renal clearance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-predictors-outcome-and-renal-clearance_en.pdf"},
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    {"id":"36525","name":"Terpenic derivatives - Article 31 referral - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2012-02-08T01:00:00Z","last_updated_date":"2012-02-08T01:00:00Z","reference_number":"EMEA/H/A-1284","document_url":"https://www.ema.europa.eu/en/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/terpenic-derivatives-article-31-referral-annex-ii_sv.pdf"}},
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    {"id":"36585","name":"EU/3/17/1928: Public summary of opinion on orphan designation : Recombinant adeno-associated viral vector serotype 5 encoding Staphylococcus aureus Cas9 endonuclease and two guide RNAs complementary to two regions of int...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T11:37:00Z","last_updated_date":"2018-01-08T11:37:00Z","reference_number":"EMA/632147/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171928-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-5-encoding-staphylococcus-aureus-cas9-endonuclease-and-two-guide-rnas-complementary-two-regions_en.pdf"},
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    {"id":"36637","name":"EU/3/07/500: Public summary of positive opinion for orphan designation of recombinant human rod-derived cone viability factor for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2015-03-06T01:00:00Z","reference_number":"EMEA/COMP/473374/2007 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307500-public-summary-positive-opinion-orphan-designation-recombinant-human-rod-derived-cone-viability-factor-treatment-retinitis-pigmentosa_en.pdf"},
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    {"id":"36642","name":"EU/3/14/1347: Public summary of opinion on orphan designation: Pyridoxal 5'-phosphate for the treatment of pyridoxamine 5'-phosphate oxidase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/551205/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141347-public-summary-opinion-orphan-designation-pyridoxal-5-phosphate-treatment-pyridoxamine-5-phosphate-oxidase-deficiency_en.pdf"},
    {"id":"36643","name":"EU/3/07/488: Public summary of positive opinion for orphan designation of everolimus for the treatment of gastro-entero-pancreatic neuroendocrine tumours","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-02T02:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMEA/COMP/467747/2007 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307488-public-summary-positive-opinion-orphan-designation-everolimus-treatment-gastro-entero-pancreatic-neuroendocrine-tumours_en.pdf"},
    {"id":"36647","name":"Norditropin - Article 13 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-04-19T02:00:00Z","last_updated_date":"2012-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/norditropin-article-13-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/norditropin-article-13-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/norditropin-article-13-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/norditropin-article-13-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/norditropin-article-13-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/norditropin-article-13-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/norditropin-article-13-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/norditropin-article-13-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/norditropin-article-13-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/norditropin-article-13-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/norditropin-article-13-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/norditropin-article-13-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/norditropin-article-13-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/norditropin-article-13-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/norditropin-article-13-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/norditropin-article-13-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/norditropin-article-13-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/norditropin-article-13-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/norditropin-article-13-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/norditropin-article-13-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/norditropin-article-13-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/norditropin-article-13-referral-annex-ii_sv.pdf"}},
    {"id":"36648","name":"Divergent position on a CVMP opinion on an Article 34 referral of Directive 2001/82/EC for Baytril 2.5% injectable, Baytril 5% injectable and Baytril\n\n10% injectable and their associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-12-10T01:00:00Z","last_updated_date":"2014-12-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-34-referral-directive-200182ec-baytril-25-injectable-baytril-5-injectable-and-baytril-10-injectable-and-their-associated-names_en.pdf"},
    {"id":"36649","name":"EU/3/05/280: Public summary of positive opinion for orphan designation of\n\nacadesine for the treatment B-cell chronic lymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2013-07-31T02:00:00Z","reference_number":"EMEA/COMP/121542/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305280-public-summary-positive-opinion-orphan-designation-acadesine-treatment-b-cell-chronic-lymphocytic-leukaemia_en.pdf"},
    {"id":"36652","name":"CVMP summary of positive opinion for Cortacare","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T16:43:00Z","last_updated_date":"2018-06-22T16:43:00Z","reference_number":"EMA/CVMP/357032/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-cortacare_en.pdf"},
    {"id":"36653","name":"Sortis-EMEA/H/A-29 PAD/1253: Article 29 Paediatrics referral - Assessment Report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-04-27T02:00:00Z","last_updated_date":"2011-04-27T02:00:00Z","reference_number":"EMA/511109/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/sortis-emeaha-29-pad1253-article-29-paediatrics-referral-assessment-report_en.pdf"},
    {"id":"36655","name":"Work instructions for checking licences for parallel distribution","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2009-06-23T02:00:00Z","last_updated_date":"2012-07-24T18:00:00Z","reference_number":"WIN/INSP/2038","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-checking-licences-parallel-distribution_en.pdf"},
    {"id":"36659","name":"Methysergide Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-05-27T02:00:00Z","last_updated_date":"2014-05-27T02:00:00Z","reference_number":"EMA/276466/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/methysergide-article-31-referral-assessment-report_en.pdf"},
    {"id":"36661","name":"Lumiracoxib - Article 107 procedures - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-12-14T00:08:21Z","last_updated_date":"2007-12-14T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lumiracoxib-article-107-procedures-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lumiracoxib-article-107-procedures-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lumiracoxib-article-107-procedures-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lumiracoxib-article-107-procedures-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lumiracoxib-article-107-procedures-annex-i_da.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lumiracoxib-article-107-procedures-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lumiracoxib-article-107-procedures-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lumiracoxib-article-107-procedures-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lumiracoxib-article-107-procedures-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lumiracoxib-article-107-procedures-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lumiracoxib-article-107-procedures-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lumiracoxib-article-107-procedures-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lumiracoxib-article-107-procedures-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lumiracoxib-article-107-procedures-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lumiracoxib-article-107-procedures-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lumiracoxib-article-107-procedures-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lumiracoxib-article-107-procedures-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lumiracoxib-article-107-procedures-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lumiracoxib-article-107-procedures-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lumiracoxib-article-107-procedures-annex-i_sv.pdf"}},
    {"id":"36662","name":"Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-09-03T14:00:00Z","last_updated_date":"2016-09-20T14:00:00Z","reference_number":"EMA/111947/2015","document_url":"https://www.ema.europa.eu/en/documents/other/task-force-implementation-international-standards-identification-medicinal-products-eu-ie-eu-iso-idmp-task-force_en.pdf"},
    {"id":"36666","name":"Withdrawal assessment report for Paccal Vet","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2012-04-25T02:00:00Z","last_updated_date":"2012-04-25T02:00:00Z","reference_number":"EMA/CVMP/170960/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-paccal-vet_en.pdf"},
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    {"id":"36668","name":"Draft assessment report on Species diureticae","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/HMPC/224754/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-species-diureticae_en.pdf"},
    {"id":"36670","name":"EU/3/14/1429: Public summary of opinion on orphan designation: N-methyl-4-({4-[({3-methyl(methylsulfonyl)aminopyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride for the treatment o...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-03-06T12:00:00Z","last_updated_date":"2015-03-06T12:00:00Z","reference_number":"EMA/COMP/793190/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141429-public-summary-opinion-orphan-designation-n-methyl-4-4-3-methylmethylsulfonylaminopyrazin-2-ylmethylamino-5-trifluoromethylpyrimidin-2-ylaminobenzamide-hydrochloride-treatment-o_en.pdf"},
    {"id":"36671","name":"EU/3/17/1853: Public summary of opinion on orphan designation: Antisense oligonucleotide targeting the USH2A gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2017-05-05T02:00:00Z","reference_number":"EMA/138353/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171853-public-summary-opinion-orphan-designation-antisense-oligonucleotide-targeting-ush2a-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"36672","name":"Presentation - Development of drugs for hospital- and ventilator-acquired pneumonia","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:45Z","last_updated_date":"2011-04-26T18:05:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-hospital-and-ventilator-acquired-pneumonia_en.pdf"},
    {"id":"36673","name":"Procedure for coordinating pharmacovigilance inspections requested by the CVMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-04-20T02:00:00Z","last_updated_date":"2009-04-20T02:00:00Z","reference_number":"EMEA/INS/PhV/85059/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-coordinating-pharmacovigilance-inspections-requested-cvmp_en.pdf"},
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    {"id":"36676","name":"Draft list of references supporting the assessment report on Echinaceae pallidae radix Echinacea pallida (Nutt.) Nutt., radix (pale coneflower root)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/332366/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-report-echinaceae-pallidae-radix-echinacea-pallida-nutt-nutt-radix-pale-coneflower-root_en.pdf"},
    {"id":"36679","name":"Meloxicam (Extension to pigs): Summary report (5) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-12-01T01:00:00Z","last_updated_date":"2000-12-01T01:00:00Z","reference_number":"EMEA/MRL/765/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/meloxicam-extension-pigs-summary-report-5-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36681","name":"Presentation - New paediatric clinical trials network in Japan (Nao Tsuchida)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T16:00:00Z","last_updated_date":"2013-07-22T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-paediatric-clinical-trials-network-japan-nao-tsuchida_en.pdf"},
    {"id":"36682","name":"Fluticasone propionate: List of nationally authorised medicinal products-  PSUSA/00001454/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T18:04:00Z","last_updated_date":"2018-01-03T18:10:01Z","reference_number":"EMA/846273/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluticasone-propionate-list-nationally-authorised-medicinal-products-psusa00001454201702_en.pdf"},
    {"id":"36683","name":"Declaration of interests - Alan Boddy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-alan-boddy_en.pdf"},
    {"id":"36685","name":"Quality and manufacturing aspects of GTMPs - Sol Ruiz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/quality-and-manufacturing-aspects-gtmps-sol-ruiz_en.pdf"},
    {"id":"36687","name":"Presentation - Signal management guidelines on good pharmacovigilance practices (GVP) IX: pilot on signals from marketing authorisation holders (Agnieszka Szmigiel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-26T02:00:00Z","last_updated_date":"2018-04-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-signal-management-guidelines-good-pharmacovigilance-practices-gvp-ix-pilot-signals-marketing-authorisation-holders-agnieszka-szmigiel_en.pdf"},
    {"id":"36689","name":"Hydroxyethyl starch Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/757392/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-31-referral-review-started_en.pdf"},
    {"id":"36690","name":"CHMP positive summary of opinion for Tolura","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"EMA/CHMP/143991/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-tolura_en.pdf"},
    {"id":"36692","name":"Zydelig Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T01:00:00Z","last_updated_date":"2016-03-11T01:00:00Z","reference_number":"EMA/191705/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-review-started_en.pdf"},
    {"id":"36693","name":"COMP meeting report on the review of applications for orphan designation: September 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-09-09T16:02:13Z","last_updated_date":"2013-09-09T16:02:13Z","reference_number":"EMA/COMP/378836/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-september-2013_en.pdf"},
    {"id":"36695","name":"Overview of comments received on 'Reflection paper on testing strategy and risk assessment for plants - draft' (EMA/CVMP/ERA/147844/2011)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-20T15:15:00Z","last_updated_date":"2011-12-20T15:15:00Z","reference_number":"EMA/CVMP/ERA/521952/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-testing-strategy-and-risk-assessment-plants-draft-emacvmpera1478442011_en.pdf"},
    {"id":"36696","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel Acino Pharma","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-06-25T02:09:21Z","last_updated_date":"2009-06-25T02:09:21Z","reference_number":"EMEA/CHMP/369869/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-acino-pharma_en.pdf"},
    {"id":"36699","name":"Presentation - Neuromyelitis optica testimonial (Irene Wilson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-neuromyelitis-optica-testimonial-irene-wilson_en.pdf"},
    {"id":"36700","name":"Melilot: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2018-04-24T18:33:00Z","last_updated_date":"2018-04-24T18:33:00Z","reference_number":"EMA/795143/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/melilot-summary-public_en.pdf"},
    {"id":"36701","name":"Is the Orphan Regulation addressing patient needs?: Yann Le Cam","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/orphan-regulation-addressing-patient-needs-yann-le-cam_en.pdf"},
    {"id":"36703","name":"Presentation - Pharmacogenomics in early drug development: Industry's view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacogenomics-early-drug-development-industrys-view_en.pdf"},
    {"id":"36705","name":"EU/3/17/1954: Public summary of opinion on orphan designation: Venetoclax for the treatment of mantle cell lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-23T14:42:00Z","last_updated_date":"2018-01-23T14:42:00Z","reference_number":"EMA/742235/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171954-public-summary-opinion-orphan-designation-venetoclax-treatment-mantle-cell-lymphoma_en.pdf"},
    {"id":"36706","name":"Sandimmun Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2014-01-30T11:10:00Z","last_updated_date":"2014-01-30T11:10:00Z","reference_number":"EMA/589500/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/sandimmun-article-30-referral-assessment-report_en.pdf"},
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    {"id":"36708","name":"Presentation - Industry views on opportunities for adaptive designs to enhance clinical development","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-views-opportunities-adaptive-designs-enhance-clinical-development_en.pdf"},
    {"id":"36709","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 20-23 June 2011","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-24T14:50:40Z","last_updated_date":"2011-06-24T14:50:40Z","reference_number":"EMA/CHMP/30246/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-june-2011_en.pdf"},
    {"id":"36710","name":"CHMP post-authorisation summary of positive opinion for Mekinist","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T14:00:00Z","last_updated_date":"2015-07-24T14:00:00Z","reference_number":"EMA/CHMP/444362/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mekinist_en.pdf-0"},
    {"id":"36713","name":"EU/3/09/710: Public summary of opinion on orphan designation of recombinant human elafin for the treatment of oesophagus carcinoma\n\nOn","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"EMA/COMP/750556/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309710-public-summary-opinion-orphan-designation-recombinant-human-elafin-treatment-oesophagus-carcinoma_en.pdf"},
    {"id":"36718","name":"CHMP post-authorisation summary of positive opinion for Azopt on 24 April 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-04-24T02:09:21Z","last_updated_date":"2008-04-24T02:09:21Z","reference_number":"EMEA/CHMP/216404/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-azopt-24-april-2008_en.pdf"},
    {"id":"36719","name":"Presentation - Implementation of new eligibility requirements (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-new-eligibility-requirements-nathalie-bere_en.pdf-0"},
    {"id":"36722","name":"Fusafungine Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-09-11T02:00:00Z","last_updated_date":"2015-09-11T02:00:00Z","reference_number":"EMA/323030/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/fusafungine-article-31-referral-annex-i_en.pdf-0"},
    {"id":"36724","name":"Inventory of EU data sources and methodological approaches for multi-source studies - Minutes of working group 3","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2008-06-09T02:00:00Z","last_updated_date":"2008-06-09T02:00:00Z","reference_number":"EMEA/382114/2008","document_url":"https://www.ema.europa.eu/en/documents/minutes/inventory-eu-data-sources-and-methodological-approaches-multi-source-studies-minutes-working-group-3_en.pdf"},
    {"id":"36728","name":"Codeine Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-05-05T17:20:00Z","last_updated_date":"2015-05-05T17:20:00Z","reference_number":"EMA/235820/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-prac-assessment-report_en.pdf-0"},
    {"id":"36732","name":"EU/3/04/190: Public summary of positive opinion for orphan designation of ethanol (96 per cent) (gel for injection) for the treatment of congenital lymphatic  malformations","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-04-28T02:00:00Z","last_updated_date":"2016-01-14T01:00:00Z","reference_number":"EMEA/COMP/70/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304190-public-summary-positive-opinion-orphan-designation-ethanol-96-cent-gel-injection-treatment-congenital-lymphatic-malformations_en.pdf"},
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    {"id":"36734","name":"CattleMarker IBR Inactivated Article-33(4) referral - Questions and answers","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-19T02:00:00Z","last_updated_date":"2016-07-19T02:00:00Z","reference_number":"EMA/290855/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cattlemarker-ibr-inactivated-article-334-referral-questions-and-answers_sv.pdf"}},
    {"id":"36735","name":"Presentation - EMA experience with the review of digital technology proposals in medicine development programmes (Francesca Cerreta)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-06T17:16:00Z","last_updated_date":"2018-06-06T17:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-experience-review-digital-technology-proposals-medicine-development-programmes-francesca-cerreta_en.pdf"},
    {"id":"36738","name":"Addendum 1 on pandemic influenza A(H1N1)v vaccines authorised via the core dossier procedure: Explanatory note on scientific considerations regarding the dosage and co-administration with seasonal vaccines recommendation...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-12-15T00:09:21Z","last_updated_date":"2009-12-15T00:09:21Z","reference_number":"EMA/693699/2009","document_url":"https://www.ema.europa.eu/en/documents/other/addendum-1-pandemic-influenza-ah1n1v-vaccines-authorised-core-dossier-procedure-explanatory-note-scientific-considerations-regarding-dosage-and-co-administration-seasonal-vaccines-recommendation_en.pdf"},
    {"id":"36740","name":"Concept paper on a proposal to limit the applicability of the CPMP/CVMP Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products to veterinary medicinal products - Superseded","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-19T15:45:00Z","last_updated_date":"2015-11-19T15:45:00Z","reference_number":"EMA/CHMP/SWP/211900/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-proposal-limit-applicability-cpmpcvmp-note-guidance-limitations-use-ethylene-oxide-manufacture-medicinal-products-veterinary-medicinal-products-superseded_en.pdf"},
    {"id":"36741","name":"Agenda - Eleventh industry stakeholder platform on the operation of EU pharmacovigilance","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-06-06T02:00:00Z","last_updated_date":"2017-06-06T02:00:00Z","reference_number":"EMA/286244/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eleventh-industry-stakeholder-platform-operation-eu-pharmacovigilance_en.pdf"},
    {"id":"36742","name":"Artemisia abrotanum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/682/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/artemisia-abrotanum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"36747","name":"EMEA Public Statement on review of recombinant Factor VIII (FVIII) products (Advate, Kogenate Bayer/Helixate NexGen, Kogenate/Helixate, Recombinate, ReFacto) and inhibitor development","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-10-18T02:09:21Z","last_updated_date":"2005-10-18T02:09:21Z","reference_number":"EMEA/331316/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-review-recombinant-factor-viii-fviii-products-advate-kogenate-bayerhelixate-nexgen-kogenatehelixate-recombinate-refacto-and-inhibitor-development_en.pdf"},
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    {"id":"36755","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, San Marino, November 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-06-14T17:00:00Z","last_updated_date":"2018-06-14T17:00:00Z","reference_number":"Course # 18520","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-san-marino-november-2018_en.pdf"},
    {"id":"36757","name":"EU/3/11/890: Public summary of opinion on orphan designation: Peretinoin for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2011-08-16T02:00:00Z","reference_number":"EMA/COMP/406301/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311890-public-summary-opinion-orphan-designation-peretinoin-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"36758","name":"Final list of references supporting the assessment of Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:00:00Z","last_updated_date":"2016-06-20T12:00:00Z","reference_number":"EMA/HMPC/150847/2015 corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-valeriana-officinalis-l-radix-and-valeriana-officinalis-l-aetheroleum_en.pdf-0"},
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    {"id":"36762","name":"Agenda - CAT agenda of the 17-18 July 2014 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T11:40:00Z","last_updated_date":"2014-07-30T11:40:00Z","reference_number":"EMA/CAT/397249/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-17-18-july-2014-meeting_en.pdf"},
    {"id":"36763","name":"Presentation - Scientific advisory groups","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T17:15:00Z","last_updated_date":"2012-05-30T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advisory-groups_en.pdf"},
    {"id":"36769","name":"Declaration of interests: Oscar Diez","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:07:20Z","last_updated_date":"2012-10-10T18:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-oscar-diez_en.pdf"},
    {"id":"36770","name":"Compliance check & Validation of applications with an agreed PIP Thorsten Olski","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/compliance-check-validation-applications-agreed-pip-thorsten-olski_en.pdf"},
    {"id":"36774","name":"CHMP summary of positive opinion for Braftovi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/476007/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-braftovi_en.pdf"},
    {"id":"36775","name":"Presentation - Better packaging and labelling for better informed patients","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-05-23T02:00:00Z","last_updated_date":"2011-05-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-better-packaging-and-labelling-better-informed-patients_en.pdf"},
    {"id":"36776","name":"Committee for medicinal products for human use summary of positive opinion for Celvapan","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-12-18T00:09:21Z","last_updated_date":"2016-12-22T00:09:21Z","reference_number":"EMEA/CHMP/657005/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-celvapan_en.pdf"},
    {"id":"36777","name":"Agenda - CAT agenda of the 12-13 December 2013 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T13:00:00Z","last_updated_date":"2013-12-17T13:00:00Z","reference_number":"EMA/CAT/793081/2013 rev. 2","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-12-13-december-2013-meeting_en.pdf"},
    {"id":"36778","name":"Agenda - European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting on 15 June 2016","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2016-06-10T12:30:00Z","last_updated_date":"2016-08-22T12:30:00Z","reference_number":"EMA/285607/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting-15-june-2016_en.pdf"},
    {"id":"36779","name":"Cyhalothrin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-04-01T02:00:00Z","last_updated_date":"2001-04-01T02:00:00Z","reference_number":"EMEA/MRL/699/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cyhalothrin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"36780","name":"Minutes of the EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations (30 November 2016)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-03-02T01:00:00Z","reference_number":"EMA/801985/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations-30-november-2016_en.pdf"},
    {"id":"36781","name":"Agenda for the 70th meeting of the Management Board, 16–17 March 2011","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2011-03-29T02:00:00Z","last_updated_date":"2011-03-29T02:00:00Z","reference_number":"EMA/MB/19969/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-70th-meeting-management-board-16-17-march-2011_en.pdf"},
    {"id":"36787","name":"Final Community herbal monograph on Cucurbita pepo L., semen","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/136024/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"36791","name":"Organisation Management Services (OMS) operating model","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-01T11:05:00Z","last_updated_date":"2019-05-06T17:50:00Z","reference_number":"EMA/459105/2016 Version 6","document_url":"https://www.ema.europa.eu/en/documents/other/organisation-management-services-oms-operating-model_en.pdf"},
    {"id":"36792","name":"Summary of transfers of appropriations in the budget 2009 - Management Board meeting: 1 October 2009","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-10-01T02:09:21Z","last_updated_date":"2009-10-01T02:09:21Z","reference_number":"EMEA/MB/320040/2009","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfers-appropriations-budget-2009-management-board-meeting-1-october-2009_en.pdf"},
    {"id":"36793","name":"Withdrawal assessment report for Megestrol Alkermes (megestrol)","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-07T11:40:00Z","last_updated_date":"2012-06-07T11:40:00Z","reference_number":"EMA/253013/2012","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-megestrol-alkermes-megestrol_en.pdf"},
    {"id":"36795","name":"EudraVigilance eXtended medicinal product dictionary acknowledgement codes","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-08T17:45:00Z","last_updated_date":"2019-07-25T11:27:00Z","reference_number":"EMA/792575/2014","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-extended-medicinal-product-dictionary-acknowledgement-codes_en.xls"},
    {"id":"36796","name":"Presentation - Redaction consultation process (Anne-Sophie Henry-Eude)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-29T02:00:00Z","last_updated_date":"2015-06-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-redaction-consultation-process-anne-sophie-henry-eude_en.pdf"},
    {"id":"36798","name":"Discussion paper on the impact of renal immaturity when investigating medicinal products intended for paediatric use","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2004-12-16T01:00:00Z","last_updated_date":"2004-12-16T01:00:00Z","reference_number":"CPMP/PEG/35132/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/discussion-paper-impact-renal-immaturity-when-investigating-medicinal-products-intended-paediatric-use_en.pdf"},
    {"id":"36801","name":"Questions and answers on refusal of a change to the marketing authorisation for Sutent (sunitinib)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-02-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/113242/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-sutent-sunitinib_en.pdf"},
    {"id":"36802","name":"EU/3/06/405: Public summary of positive opinion for orphan designation\n\nof genetically modified allogenic (human) tumour cells for the expression of IL-7, GM-CSF, CD80 and CD154, in fixed combination with a DNA-based dou...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/222234/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306405-public-summary-positive-opinion-orphan-designation-genetically-modified-allogenic-human-tumour-cells-expression-il-7-gm-csf-cd80-and-cd154-fixed-combination-dna-based-dou_en.pdf"},
    {"id":"36803","name":"Agenda - Draft workshop programme - Joint European Medicines Agency/European Directorate for the Quality of Medicines and Healthcare workshop on improved potency assays for inactivated influenza vaccines","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2011-12-07T01:00:00Z","last_updated_date":"2011-12-07T01:00:00Z","reference_number":"EMA/902224/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-draft-workshop-programme-joint-european-medicines-agencyeuropean-directorate-quality-medicines-and-healthcare-workshop-improved-potency-assays-inactivated-influenza-vaccines_en.pdf"},
    {"id":"36804","name":"Presentation - Interaction with patients and consumers (2013): Review of EPAR summaries (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T01:00:00Z","last_updated_date":"2014-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-patients-and-consumers-2013-review-epar-summaries-nathalie-bere_en.pdf"},
    {"id":"36806","name":"Testosterone (topical use): List of nationally authorised medicinal products - PSUSA/00002908/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-03T15:36:00Z","last_updated_date":"2016-11-17T15:35:00Z","reference_number":"EMA/724798/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/testosterone-topical-use-list-nationally-authorised-medicinal-products-psusa00002908201512_en.pdf"},
    {"id":"36810","name":"National contact points for standalone signal notifications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T11:55:00Z","last_updated_date":"2021-08-03T14:00:00Z","reference_number":"EMA/777916/2017 Corr. 2","document_url":"https://www.ema.europa.eu/en/documents/other/national-contact-points-standalone-signal-notifications_en.xlsx"},
    {"id":"36811","name":"EU/3/05/333: Public summary of positive opinion for orphan designation of eptacog alpha (activated) for the treatment of diffuse alveolar haemorrhage","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-01T01:00:00Z","last_updated_date":"2021-09-21T11:18:00Z","reference_number":"EMEA/COMP/370803/2005 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305333-public-summary-positive-opinion-orphan-designation-eptacog-alpha-activated-treatment-diffuse-alveolar-haemorrhage_en.pdf"},
    {"id":"36815","name":"Committee for Advanced Therapies (CAT): September 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-10-04T02:00:00Z","last_updated_date":"2011-10-04T02:00:00Z","reference_number":"EMA/CAT/770104/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-september-2011-meeting-monthly-report_en.pdf"},
    {"id":"36820","name":"CHMP summary of positive opinion for Aripiprazole Zentiva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T14:00:00Z","last_updated_date":"2015-04-24T14:00:00Z","reference_number":"EMA/CHMP/232372/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aripiprazole-zentiva_en.pdf"},
    {"id":"36821","name":"Presentation - Draft guideline on biosimilar monoclonal antibodies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:44Z","last_updated_date":"2012-06-15T17:10:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-guideline-biosimilar-monoclonal-antibodies_en.pdf"},
    {"id":"36822","name":"Final list of references supporting the assessment of Glycine max (L.) Merr., oleum raffinatum","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2017-03-03T10:19:00Z","last_updated_date":"2017-03-03T10:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-glycine-max-l-merr-oleum-raffinatum_en.pdf"},
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    {"id":"36825","name":"Report on the joint European Medicines Agency / Heads of Medicines Agencies workshop on requirements for the authorisation of vaccines within the European Union","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-07-13T17:00:00Z","last_updated_date":"2015-07-13T17:00:00Z","reference_number":"EMA/258437/2015","document_url":"https://www.ema.europa.eu/en/documents/report/report-joint-european-medicines-agency-heads-medicines-agencies-workshop-requirements-authorisation-vaccines-within-european-union_en.pdf"},
    {"id":"36826","name":"Final Community herbal monograph on Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2013-03-25T01:00:00Z","last_updated_date":"2013-03-25T01:00:00Z","reference_number":"EMA/HMPC/897344/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-paullinia-cupana-kunth-ex-hbk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
    {"id":"36828","name":"Presentation - Session 1: A regulatory perspective: what do I want to know? (June M Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-regulatory-perspective-what-do-i-want-know-june-m-raine_en.pdf"},
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    {"id":"36842","name":"Withdrawal letter : Zavesca","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-02-19T01:00:00Z","last_updated_date":"2008-02-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-zavesca_en.pdf"},
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    {"id":"36850","name":"Assessment report for Zinacef and associated names","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-01-29T01:00:00Z","last_updated_date":"2013-01-29T01:00:00Z","reference_number":"EMA/CHMP/633654/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-zinacef-and-associated-names_en.pdf"},
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    {"id":"36853","name":"Presentation - The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP): Facilitating the conduct of post-authorisation study (PAS) (Henry Fitt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-12T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-centres-pharmacoepidemiology-and-pharmacovigilance-encepp-facilitating-conduct-post-authorisation-study-pas-henry-fitt_en.pdf"},
    {"id":"36854","name":"Superseded final community herbal monograph on ,Passiflora incarnate L., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-09-07T02:09:21Z","last_updated_date":"2014-06-18T02:09:21Z","reference_number":"EMEA/HMPC/230962/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-passiflora-incarnate-l-herba_en.pdf"},
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    {"id":"36858","name":"Hydrochlorothiazide / olmesartan: List of nationally authorised medicinal products - PSUSA/00002209/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-15T13:30:00Z","last_updated_date":"2017-06-15T13:30:00Z","reference_number":"EMA/379727/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-olmesartan-list-nationally-authorised-medicinal-products-psusa00002209201610_en.pdf"},
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    {"id":"36874","name":"Final assessment report on Origanum majorana L., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T11:30:00Z","last_updated_date":"2016-11-15T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-origanum-majorana-l-herba_en.pdf"},
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    {"id":"36877","name":"EU/3/14/1383: Public summary of positive opinion for orphan designation: Single-chain urokinase plasminogen activator for the treatment of pleural empyema","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/735886/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141383-public-summary-positive-opinion-orphan-designation-single-chain-urokinase-plasminogen-activator-treatment-pleural-empyema_en.pdf"},
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    {"id":"36879","name":"EU/3/16/1656: Public summary of opinion on orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/254123/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161656-public-summary-opinion-orphan-designation-tyr-met-phe-pro-asn-ala-pro-tyr-leu-ser-gly-gln-ala-tyr-met-phe-pro-asn-ala-pro-tyr-leu-pro-ser-cys-leu-glu-ser-arg-ser-asp-glu-leu-val-arg-his-his_en.pdf"},
    {"id":"36881","name":"Public statement on the recommendation to lift the suspension of the marketing authorisation for Optison (perflutren)","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-06-29T02:09:21Z","last_updated_date":"2009-06-29T02:09:21Z","reference_number":"EMEA/367523/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-recommendation-lift-suspension-marketing-authorisation-optison-perflutren_en.pdf"},
    {"id":"36882","name":"European Medicines Agency mid-year report 2010 from the Executive Director (January - June 2010)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-10-15T02:00:00Z","last_updated_date":"2010-10-15T02:00:00Z","reference_number":"EMA/MB/511982/2010","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-mid-year-report-2010-executive-director-january-june-2010_en.pdf"},
    {"id":"36883","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 16-19 December 2013","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2013-12-20T13:00:00Z","last_updated_date":"2013-12-20T13:00:00Z","reference_number":"EMA/CHMP/SAWP/807436/2013","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-16-19-december-2013_en.pdf"},
    {"id":"36884","name":"Presentation - How to facilitate the communicationsdata exchange, Janice Soreth","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-facilitate-communicationsdata-exchange-janice-soreth_en.pdf"},
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    {"id":"36906","name":"Draft reflection paper on the use of third and fourth generation cephalosporins in food-producing animals in the European Union: Development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-02-18T01:00:00Z","last_updated_date":"2008-02-18T01:00:00Z","reference_number":"EMEA/CVMP/SAGAM/81730/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-third-and-fourth-generation-cephalosporins-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"36907","name":"Draft assessment report on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-10-20T02:00:00Z","last_updated_date":"2011-10-20T02:00:00Z","reference_number":"EMA/HMPC/337067/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-or-their-mixtures-flos-first-version_en.pdf"},
    {"id":"36908","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 10-12 December 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-12-22T10:15:00Z","last_updated_date":"2014-12-22T10:15:00Z","reference_number":"EMA/PDCO/780247/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-10-12-december-2014_en.pdf"},
    {"id":"36909","name":"Denagard 45% Article-34 referral - Annex I,II,III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-08-11T19:00:00Z","last_updated_date":"2017-08-11T19:00:00Z","reference_number":"EMEA/V/A/114","document_url":"https://www.ema.europa.eu/en/documents/referral/denagard-45-article-34-referral-annex-iiiiii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/denagard-45-article-34-referral-annex-iiiiii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/denagard-45-article-34-referral-annex-iiiiii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/denagard-45-article-34-referral-annex-iiiiii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/denagard-45-article-34-referral-annex-iiiiii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/denagard-45-article-34-referral-annex-iiiiii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/denagard-45-article-34-referral-annex-iiiiii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/denagard-45-article-34-referral-annex-iiiiii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/denagard-45-article-34-referral-annex-iiiiii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/denagard-45-article-34-referral-annex-iiiiii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/denagard-45-article-34-referral-annex-iiiiii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/denagard-45-article-34-referral-annex-iiiiii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/denagard-45-article-34-referral-annex-iiiiii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/denagard-45-article-34-referral-annex-iiiiii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/denagard-45-article-34-referral-annex-iiiiii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/denagard-45-article-34-referral-annex-iiiiii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/denagard-45-article-34-referral-annex-iiiiii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/denagard-45-article-34-referral-annex-iiiiii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/denagard-45-article-34-referral-annex-iiiiii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/denagard-45-article-34-referral-annex-iiiiii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/denagard-45-article-34-referral-annex-iiiiii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/denagard-45-article-34-referral-annex-iiiiii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/denagard-45-article-34-referral-annex-iiiiii_sv.pdf"}},
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    {"id":"36915","name":"Felbamate: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -PSUSA/00010155/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-18T02:00:00Z","last_updated_date":"2017-09-18T16:54:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_sv.pdf","is":"https://www.ema.europa.eu/is/documents/psusa/felbamate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010155201609_is.pdf","no":"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    {"id":"36916","name":"Participants list from the 5th industry stakeholder platform - Operation of EU pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"EMA/47443/2016","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-5th-industry-stakeholder-platform-operation-eu-pharmacovigilance-legislation_en.pdf"},
    {"id":"36917","name":"Proposal for involvement and participation of patients consumers representatives in the meetings of the Committee for Medicinal Products for Human Use Pharmacovigilance Working Party","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-03-11T01:00:00Z","last_updated_date":"2009-03-11T01:00:00Z","reference_number":"EMEA/261645/2008Endorsed","document_url":"https://www.ema.europa.eu/en/documents/report/proposal-involvement-and-participation-patients-consumers-representatives-meetings-committee-medicinal-products-human-use-pharmacovigilance-working-party_en.pdf"},
    {"id":"36919","name":"CHMP post-authorisation summary of positive opinion for Lantus","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T02:00:00Z","last_updated_date":"2012-04-20T02:00:00Z","reference_number":"EMA/CHMP/184674/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lantus_en.pdf"},
    {"id":"36920","name":"Presentation - Non imposed post authorisation safety studies (PASS) protocols (Jane Moseley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-imposed-post-authorisation-safety-studies-pass-protocols-jane-moseley_en.pdf"},
    {"id":"36921","name":"Overview of comments received on 'Guideline on clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T10:35:00Z","last_updated_date":"2015-07-24T10:35:00Z","reference_number":"EMA/CHMP/BPWP/356919/2013","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-clinical-investigation-human-normal-immunoglobulin-subcutaneous-andor-intramuscular-administration_en.pdf"},
    {"id":"36923","name":"Prudent use of cephalosporins, Experience and observations - Valà©rie Thomas","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/prudent-use-cephalosporins-experience-and-observations-valacrie-thomas_en.pdf"},
    {"id":"36924","name":"Minutes of the Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Group (HCPWG) joint meeting: September 2012","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T17:00:00Z","last_updated_date":"2012-11-26T17:00:00Z","reference_number":"EMA/685483/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-group-hcpwg-joint-meeting-september-2012_en.pdf"},
    {"id":"36928","name":"Presentation - HCPWP/PCWP feedback from CHMP (Fà¡tima Ventura, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T02:00:00Z","last_updated_date":"2017-09-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hcpwppcwp-feedback-chmp-fatima-ventura-ema_en.pdf"},
    {"id":"36930","name":"Draft list of references supporting the assessment of Sambucus nigra L., fructus","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-04-19T02:00:00Z","last_updated_date":"2013-04-19T02:00:00Z","reference_number":"EMA/HMPC/44212/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"36931","name":"Superseded community herbal monograph on Juniperus communis L., pseudo-fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-28T01:00:00Z","last_updated_date":"2023-06-13T01:00:00Z","reference_number":"EMA/HMPC/441929/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-juniperus-communis-l-pseudo-fructus_en.pdf"},
    {"id":"36932","name":"Opinion following an Article-33(4) referral for Nuflor Swine Once 450-mg/ml solution for injection","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"EMA/324738/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-nuflor-swine-once-450-mgml-solution-injection_sv.pdf"}},
    {"id":"36933","name":"Presentation - PCWP and HCPWP topic groups update (N. Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T17:12:00Z","last_updated_date":"2017-12-11T17:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwp-and-hcpwp-topic-groups-update-n-bere_en.pdf"},
    {"id":"36934","name":"Report on workshop on the development of an EMEA transparency policy, 22nd January 2009","type":"report","status":"unknown","consultation_date":"","first_published_date":"2009-04-06T02:00:00Z","last_updated_date":"2009-04-06T02:00:00Z","reference_number":"EMEA/91746/2009","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-development-emea-transparency-policy-22nd-january-2009_en.pdf"},
    {"id":"36935","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Ninlaro (ixazomib) for the treatment of multiple myeloma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-12-07T12:00:00Z","last_updated_date":"2016-12-07T12:00:00Z","reference_number":"EMA/692567/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-ninlaro-ixazomib-treatment-multiple-myeloma_en.pdf"},
    {"id":"36936","name":"European Medicines Agency recommends authorisation of first medicine specifically for irritable bowel syndrome","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-09-21T14:02:00Z","last_updated_date":"2012-09-21T14:02:00Z","reference_number":"EMA/CHMP/611096/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-authorisation-first-medicine-specifically-irritable-bowel-syndrome_en.pdf"},
    {"id":"36938","name":"Presentation - Practical aspects of working electronically in the network (Pieter Vankeerberghen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T02:00:00Z","last_updated_date":"2013-05-21T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-practical-aspects-working-electronically-network-pieter-vankeerberghen_en.pdf"},
    {"id":"36939","name":"Presentation - Topic 1 - Academia-health care professionals perspective Accelerate-SIOPE-ITCC - Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation (Gilles Vassal, Gustave Roussy...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-1-academia-health-care-professionals-perspective-accelerate-siope-itcc-multi-stakeholder-workshop-further-improve-implementation-paediatric-regulation-gilles-vassal-gustave-roussy_en.pdf"},
    {"id":"36940","name":"European Medicines Agency holds Focus Group meeting on fibrosarcoma occurring at sites of injection of veterinary medicines in cats","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T14:49:21Z","last_updated_date":"2007-07-19T14:49:21Z","reference_number":"EMEA/CVMP/PhVWP/296279/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-holds-focus-group-meeting-fibrosarcoma-occurring-sites-injection-veterinary-medicines-cats_en.pdf"},
    {"id":"36942","name":"Committee for Orphan Medicinal Products (COMP) meetings 2013-2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-26T17:30:00Z","last_updated_date":"2015-02-18T11:10:00Z","reference_number":"EMA/COMP/478907/2009 Corr","document_url":"https://www.ema.europa.eu/en/documents/other/committee-orphan-medicinal-products-comp-meetings-2013-2015_en.pdf"},
    {"id":"36944","name":"Report analysis of scientific guidelines - European Medicines Agency Geriatric Medicines Strategy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-10-17T17:30:00Z","last_updated_date":"2013-10-17T17:30:00Z","reference_number":"EMA/352591/2013","document_url":"https://www.ema.europa.eu/en/documents/report/report-analysis-scientific-guidelines-european-medicines-agency-geriatric-medicines-strategy_en.pdf"},
    {"id":"36945","name":"Loratadine : List of nationally authorised medicinal products - PSUSA/00001907/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-05T17:06:00Z","last_updated_date":"2017-10-05T17:08:49Z","reference_number":"EMA/658556/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/loratadine-list-nationally-authorised-medicinal-products-psusa00001907201702_en.pdf"},
    {"id":"36946","name":"Public statement on Fortovase: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2006-08-07T02:00:00Z","last_updated_date":"2006-08-07T02:00:00Z","reference_number":"EMEA/304680/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-fortovase-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"36950","name":"Presentation - Industry representation within the Enpr-EMA Coordinating Group (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T14:00:00Z","last_updated_date":"2014-07-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-representation-within-enpr-ema-coordinating-group-irmgard-eichler_en.pdf"},
    {"id":"36951","name":"New study suggests risk of birth defects in babies born to women on HIV medicine dolutegravir","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-05-18T14:00:00Z","last_updated_date":"2018-05-18T14:00:00Z","reference_number":"EMA/295960/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-study-suggests-risk-birth-defects-babies-born-women-hiv-medicine-dolutegravir_en.pdf"},
    {"id":"36952","name":"Sampling and testing of centrally authorised products: Objectives and description of the programme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-01-06T01:00:00Z","last_updated_date":"2005-01-06T01:00:00Z","reference_number":"EMEA/INS/S&T/5291/2005","document_url":"https://www.ema.europa.eu/en/documents/other/sampling-and-testing-centrally-authorised-products-objectives-and-description-programme_en.pdf"},
    {"id":"36953","name":"Presentation - Update on Pharmacovigilance systems and services (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-25T01:00:00Z","last_updated_date":"2016-01-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-pharmacovigilance-systems-and-services-peter-arlett_en.pdf-0"},
    {"id":"36955","name":"Superseded final list of references supporting the assessment of Achillea millefolium L., herba - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2011-09-30T02:00:00Z","last_updated_date":"2011-09-30T02:00:00Z","reference_number":"EMA/HMPC/290282/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-references-supporting-assessment-achillea-millefolium-l-herba-first-version_en.pdf"},
    {"id":"36956","name":"CHMP summary of positive opinion for Relvar Ellipta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/476694/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-relvar-ellipta_en.pdf"},
    {"id":"36957","name":"Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with st segment elevation acute myocardial infarction (STEMI)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-06-26T02:00:00Z","last_updated_date":"2003-06-26T02:00:00Z","reference_number":"CPMP/EWP/967/01","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-clinical-development-fibrinolytic-medicinal-products-treatment-patients-st-segment-elevation-acute-myocardial-infarction-stemi_en.pdf"},
    {"id":"36958","name":"Final list of references supporting the assessment of Glycine max (L.) Merr., semen - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-07-31T02:00:00Z","last_updated_date":"2018-07-31T02:00:00Z","reference_number":"EMA/HMPC/607531/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-glycine-max-l-merr-semen-first-version_en.pdf"},
    {"id":"36959","name":"Ampicillin / sulbactam: List of nationally authorised medicinal products - PSUSA/00000197/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-30T01:00:00Z","last_updated_date":"2016-10-17T19:40:14Z","reference_number":"EMA/801642/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/ampicillin-sulbactam-list-nationally-authorised-medicinal-products-psusa00000197201502_en.pdf"},
    {"id":"36960","name":"Presentation - Excipients general approach","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-30T01:00:00Z","last_updated_date":"2012-01-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-excipients-general-approach_en.pdf"},
    {"id":"36962","name":"Dexamed and associated names Article-29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-02T02:00:00Z","last_updated_date":"2014-09-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/dexamed-and-associated-names-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"36964","name":"EU/3/08/546: Public summary of positive opinion for orphan designation of alpha-1 proteinase inhibitor (for inhalation use) for the treatment of congenital alpha-1 antitrypsin deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2013-10-17T16:00:00Z","reference_number":"EMA/COMP/211433/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308546-public-summary-positive-opinion-orphan-designation-alpha-1-proteinase-inhibitor-inhalation-use-treatment-congenital-alpha-1-antitrypsin-deficiency_en.pdf"},
    {"id":"36965","name":"Presentation - Working group to address issues with European Union multi-languages of young patient advisory groups","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-address-issues-european-union-multi-languages-young-patient-advisory-groups_en.pdf"},
    {"id":"36969","name":"Ibuprofen and dexibuprofen Article-31 referral - PRAC recommends updating advice on use of high-dose ibuprofen","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-04-13T12:00:00Z","last_updated_date":"2015-04-13T12:00:00Z","reference_number":"EMA/217862/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/ibuprofen-and-dexibuprofen-article-31-referral-prac-recommends-updating-advice-use-high-dose-ibuprofen_en.pdf"},
    {"id":"36972","name":"CHMP post-authorisation summary of positive opinion for Onglyza","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-01-18T01:00:00Z","reference_number":"EMA/CHMP/35984/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-onglyza_en.pdf-1"},
    {"id":"36973","name":"Tiludronic acid: List of nationally authorised medicinal products - PSUSA/00002959/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-13T14:00:00Z","last_updated_date":"2016-10-17T15:59:33Z","reference_number":"EMA/650026/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/tiludronic-acid-list-nationally-authorised-medicinal-products-psusa00002959201502_en.pdf"},
    {"id":"36975","name":"Expectations from pharmacokinetic-pharmacodynamic modelling and simulation in the evaluation of medicinal products in children","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-05-15T02:09:21Z","last_updated_date":"2008-05-15T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/expectations-pharmacokinetic-pharmacodynamic-modelling-and-simulation-evaluation-medicinal-products-children_en.pdf"},
    {"id":"36976","name":"European Medicines Agency recommends authorisation of first medicine for Castleman's disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/163651/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-authorisation-first-medicine-castlemans-disease_en.pdf"},
    {"id":"36979","name":"CHMP summary of positive opinion for Iclusig","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T01:00:00Z","last_updated_date":"2013-03-22T01:00:00Z","reference_number":"EMA/CHMP/178415/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-iclusig_en.pdf"},
    {"id":"36980","name":"Points to consider on clinical investigation of medicinal products in the chronic treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-05-19T02:00:00Z","last_updated_date":"1999-05-19T02:00:00Z","reference_number":"CPMP/EWP/562/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-clinical-investigation-medicinal-products-chronic-treatment-patients-chronic-obstructive-pulmonary-disease-copd_en.pdf"},
    {"id":"36982","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 16-18 July 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-29T13:00:00Z","last_updated_date":"2014-07-29T13:00:00Z","reference_number":"EMA/443651/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-16-18-july-2014_en.pdf"},
    {"id":"36984","name":"Submission of comments on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (EMA/816573/2011)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-22T13:20:00Z","last_updated_date":"2012-02-22T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-ema8165732011_en.doc"},
    {"id":"36985","name":"COMP meeting report on the review of applications for orphan designation: September 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-09-19T13:00:00Z","last_updated_date":"2016-09-19T13:00:00Z","reference_number":"EMA/COMP/498821/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-september-2016_en.pdf"},
    {"id":"36986","name":"Public statement on Tredaptive: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-05-16T02:00:00Z","last_updated_date":"2013-05-16T02:00:00Z","reference_number":"EMA/290249/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-tredaptive-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"36999","name":"EMA Management Board: highlights of March 2015 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-20T01:00:00Z","last_updated_date":"2015-03-20T01:00:00Z","reference_number":"EMA/188328/2015 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-march-2015-meeting_en.pdf"},
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    {"id":"37006","name":"Agenda - Brain Diseases in the Elderly; Joint workshop - European School for Scientific and Regulatory Assessment of New Medicines and European Medicines Agency (EMEA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2008-05-16T02:09:21Z","last_updated_date":"2008-05-16T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-brain-diseases-elderly-joint-workshop-european-school-scientific-and-regulatory-assessment-new-medicines-and-european-medicines-agency-emea_en.pdf"},
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    {"id":"37014","name":"Presentation - Spanish Surveillance of Veterinary Antimicrobial Consumption (Cristina Muà±oz Madero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-22T13:01:31Z","last_updated_date":"2010-12-22T13:01:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spanish-surveillance-veterinary-antimicrobial-consumption-cristina-mua-oz-madero_en.pdf"},
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    {"id":"37023","name":"Public statement on Velosulin: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2009-04-14T02:00:00Z","last_updated_date":"2009-04-17T02:00:00Z","reference_number":"EMEA/86738/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-velosulin-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"37025","name":"Template to request access to EMA ICT facilities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-13T02:00:00Z","last_updated_date":"2012-07-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/template-request-access-ema-ict-facilities_en.pdf"},
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    {"id":"37028","name":"ICH: Q 4 B Annex 1: Annex to regulatory acceptance of analytical procedures and/or acceptance criteria (RAAPAC) - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"EMEA/CHMP/ICH/222063/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-1-annex-regulatory-acceptance-analytical-procedures-andor-acceptance-criteria-raapac-step-3_en.pdf"},
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    {"id":"37030","name":"EU/3/18/2027: Public summary of opinion on orphan designation: Three human monoclonal antibodies against the EBOV glycoprotein for the treatment of Ebola virus disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T17:07:00Z","last_updated_date":"2018-07-23T17:07:00Z","reference_number":"EMA/270111/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182027-public-summary-opinion-orphan-designation-three-human-monoclonal-antibodies-against-ebov-glycoprotein-treatment-ebola-virus-disease_en.pdf"},
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    {"id":"37039","name":"Sixteenth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1997-12-05T01:00:00Z","last_updated_date":"1997-12-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/sixteenth-meeting-management-board_en.pdf"},
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    {"id":"37043","name":"Fibrinogen Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T17:00:00Z","last_updated_date":"2013-04-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fibrinogen-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fibrinogen-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fibrinogen-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fibrinogen-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fibrinogen-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fibrinogen-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fibrinogen-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fibrinogen-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fibrinogen-article-31-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fibrinogen-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fibrinogen-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fibrinogen-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fibrinogen-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fibrinogen-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fibrinogen-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fibrinogen-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fibrinogen-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fibrinogen-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fibrinogen-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fibrinogen-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fibrinogen-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fibrinogen-article-31-referral-annex-i_sv.pdf"}},
    {"id":"37045","name":"Moxifloxacin - Article 107 procedures - Annex I","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-07-24T02:08:21Z","last_updated_date":"2007-07-24T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/moxifloxacin-article-107-procedures-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/moxifloxacin-article-107-procedures-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/moxifloxacin-article-107-procedures-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/moxifloxacin-article-107-procedures-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/moxifloxacin-article-107-procedures-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/moxifloxacin-article-107-procedures-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/moxifloxacin-article-107-procedures-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/moxifloxacin-article-107-procedures-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/moxifloxacin-article-107-procedures-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/moxifloxacin-article-107-procedures-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/moxifloxacin-article-107-procedures-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/moxifloxacin-article-107-procedures-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/moxifloxacin-article-107-procedures-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/moxifloxacin-article-107-procedures-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/moxifloxacin-article-107-procedures-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/moxifloxacin-article-107-procedures-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/moxifloxacin-article-107-procedures-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/moxifloxacin-article-107-procedures-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/moxifloxacin-article-107-procedures-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/moxifloxacin-article-107-procedures-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/moxifloxacin-article-107-procedures-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/moxifloxacin-article-107-procedures-annex-i_sv.pdf"}},
    {"id":"37046","name":"EMA collaboration with general practitioners/ family physicians (GPs/FPs): Report from a joint EMA workshop with EFPC, UEMO and WONCA-Europe organised on 19 April 2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-06-16T17:50:00Z","last_updated_date":"2016-06-16T17:50:00Z","reference_number":"EMA/281593/2016","document_url":"https://www.ema.europa.eu/en/documents/report/ema-collaboration-general-practitioners-family-physicians-gpsfps-report-joint-ema-workshop-efpc-uemo-and-wonca-europe-organised-19-april-2016_en.pdf"},
    {"id":"37047","name":"Invitation for expressions of interest - European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-09-13T17:52:00Z","last_updated_date":"2018-09-13T17:52:00Z","reference_number":"EMA/457607/2018","document_url":"https://www.ema.europa.eu/en/documents/other/invitation-expressions-interest-european-medicines-agency-stakeholder-interaction-development-medicinal-products-chronic-non-infectious-liver-diseases-pbc-psc-nash_en.pdf"},
    {"id":"37048","name":"EU/3/14/1335: Public summary of opinion on orphan designation: (S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile for the treatment of pemphigus","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2018-02-22T13:00:00Z","reference_number":"EMA/COMP/557455/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141335-public-summary-opinion-orphan-designation-s-2-1-6-amino-5-cyanopyrimidin-4-ylaminoethyl-4-oxo-3-phenyl-34-dihydropyrrolo21-f124triazine-5-carbonitrile-treatment-pemphigus_en.pdf"},
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    {"id":"37051","name":"EMEA response to ISDB assessment of 9 EPARs","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"1998-12-18T00:09:21Z","last_updated_date":"1998-12-18T00:09:21Z","reference_number":"EMEA/42941/98","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-response-isdb-assessment-9-epars_en.pdf"},
    {"id":"37052","name":"Presentation - Survey on involvement of healthcare professionals, patients and consumers in 2014: results (Merel Stroucken)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-16T02:00:00Z","last_updated_date":"2015-04-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-involvement-healthcare-professionals-patients-and-consumers-2014-results-merel-stroucken_en.pdf"},
    {"id":"37057","name":"Tilmicosin (extension to milk): Summary Report (4) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-04-01T02:09:21Z","last_updated_date":"2000-04-01T02:09:21Z","reference_number":"EMEA/MRL/736/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tilmicosin-extension-milk-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37058","name":"Vancomycin Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-11T18:45:00Z","last_updated_date":"2017-11-17T17:45:00Z","reference_number":"EMA/258475/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/vancomycin-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/vancomycin-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/vancomycin-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/vancomycin-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/vancomycin-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/vancomycin-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/vancomycin-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/vancomycin-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/vancomycin-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/vancomycin-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/vancomycin-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/vancomycin-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/vancomycin-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/vancomycin-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/vancomycin-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/vancomycin-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/vancomycin-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/vancomycin-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/vancomycin-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/vancomycin-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/vancomycin-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/vancomycin-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/vancomycin-article-31-referral-annex-i_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/vancomycin-article-31-referral-annex-i_no.pdf"}},
    {"id":"37059","name":"EU/3/17/1924: Public summary of opinion on orphan designation: Glucopyranosyl lipid A stable emulsion for the treatment of follicular lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T15:45:00Z","last_updated_date":"2019-10-15T15:45:00Z","reference_number":"EMA/COMP/632529/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171924-public-summary-opinion-orphan-designation-glucopyranosyl-lipid-stable-emulsion-treatment-follicular-lymphoma_en.pdf"},
    {"id":"37060","name":"Scientific recommendation on classification of advanced therapy medicinal product: Adenoviral vector expressing the non-structural region of hepatitis C virus (HCV) in which a mutation has been introduced","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-08-06T12:00:00Z","last_updated_date":"2013-08-06T12:00:00Z","reference_number":"EMA/479938/2013 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-product-adenoviral-vector-expressing-non-structural-region-hepatitis-c-virus-hcv-which-mutation-has-been-introduced_en.pdf"},
    {"id":"37063","name":"Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-12-12T11:00:00Z","last_updated_date":"2015-08-11T11:00:00Z","reference_number":"EMA/228028/2012 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-iv-pharmacovigilance-audits-rev-1_en.pdf"},
    {"id":"37064","name":"Committee for Advanced Therapies (CAT): March 2009 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-03-27T01:00:00Z","last_updated_date":"2009-03-27T01:00:00Z","reference_number":"EMEA/CAT/169206/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-march-2009-meeting-monthly-report_en.pdf"},
    {"id":"37065","name":"Draft list of references supporting the assessment of Cetraria islandica (L.) Acharius s.l., thallus - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2014-05-19T02:00:00Z","last_updated_date":"2014-05-19T02:00:00Z","reference_number":"EMA/HMPC/36865/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-cetraria-islandica-l-acharius-sl-thallus-first-version_en.pdf"},
    {"id":"37066","name":"EU/3/17/1878: Public summary of opinion on orphan designation: Ursodeoxycholic acid for the treatment of Niemann-Pick disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-29T02:00:00Z","last_updated_date":"2017-06-29T02:00:00Z","reference_number":"EMA/270550/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171878-public-summary-opinion-orphan-designation-ursodeoxycholic-acid-treatment-niemann-pick-disease_en.pdf"},
    {"id":"37067","name":"Overview of comments on 'Draft guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-10-03T11:36:00Z","last_updated_date":"2011-10-03T11:36:00Z","reference_number":"EMA/358709/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-draft-guideline-core-summary-product-characteristics-and-package-leaflet-radiopharmaceuticals_en.pdf"},
    {"id":"37069","name":"Presentation - CARs and TRUCKs: how engineered T cells become living factories(Hinrich Abken)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cars-and-trucks-how-engineered-t-cells-become-living-factorieshinrich-abken_en.pdf"},
    {"id":"37071","name":"Presentation - Guideline on good pharmacovigilance practices GVP module XVI addendum I - Educational materials (Margarida Guimaraes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-good-pharmacovigilance-practices-gvp-module-xvi-addendum-i-educational-materials-margarida-guimaraes_en.pdf"},
    {"id":"37072","name":"Alcover Article-29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2018-01-12T01:00:00Z","last_updated_date":"2018-01-12T01:00:00Z","reference_number":"EMA/833636/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/alcover-article-294-referral-assessment-report_en.pdf"},
    {"id":"37073","name":"Monthly report - Pharmacovigilance Working Party (PhVWP) September 2011 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-09-29T12:30:00Z","last_updated_date":"2011-09-29T12:30:00Z","reference_number":"EMA/CHMP/PhVWP/776580/2011","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-september-2011-plenary-meeting_en.pdf"},
    {"id":"37075","name":"Second EMEA - EGA Info Day; Generic and Biosimilar Medicines in the Centralised Procedure - Registration form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:09:21Z","last_updated_date":"2008-07-24T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/second-emea-ega-info-day-generic-and-biosimilar-medicines-centralised-procedure-registration-form_en.pdf"},
    {"id":"37077","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12-14 November 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T13:00:00Z","last_updated_date":"2014-11-24T13:00:00Z","reference_number":"EMA/PDCO/704339/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-14-november-2014_en.pdf"},
    {"id":"37078","name":"Presentation - Cell-based therapy advanced-therapy medicinal products: Manufacturing of cell-based therapy products: common issues and advice","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cell-based-therapy-advanced-therapy-medicinal-products-manufacturing-cell-based-therapy-products-common-issues-and-advice_en.pdf"},
    {"id":"37079","name":"Hydroxyethyl starch Article-107i referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/171888/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-assessment-report_en.pdf"},
    {"id":"37080","name":"Development pharmaceutics for biotechnological and biological products (CPMP/BWP/328/99)\n\nAnnex to note for guidance on development pharmaceutics (CPMP/QWP/155/96)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1999-10-21T02:00:00Z","last_updated_date":"1999-10-21T02:00:00Z","reference_number":"CPMP/BWP/328/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/development-pharmaceutics-biotechnological-and-biological-products-cpmpbwp32899-annex-note-guidance-development-pharmaceutics-cpmpqwp15596_en.pdf"},
    {"id":"37083","name":"Questions and answers on the refusal of the marketing authorisation for Folotyn (pralatrexate)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T02:00:00Z","last_updated_date":"2012-07-11T02:00:00Z","reference_number":"EMA/CHMP/255106/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-folotyn-pralatrexate_sv.pdf"}},
    {"id":"37085","name":"Dicyclanil: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-03-01T01:00:00Z","last_updated_date":"2000-03-01T01:00:00Z","reference_number":"EMEA/MRL/733/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dicyclanil-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37086","name":"Amlodipine/candesartan: List of nationally authorised medicinal products - PSUSA/00010191/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-18T11:08:00Z","last_updated_date":"2018-01-18T11:10:00Z","reference_number":"EMA/34107/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipinecandesartan-list-nationally-authorised-medicinal-products-psusa00010191201704_en.pdf"},
    {"id":"37087","name":"Questions and answers on refusal of a change to the marketing authorisation for Arzerra (ofatumumab)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/433595/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-arzerra-ofatumumab_en.pdf"},
    {"id":"37090","name":"Presentation - Subgroup analysis: trying to get more from less? (Stephen Senn et al.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-subgroup-analysis-trying-get-more-less-stephen-senn-et-al_en.pdf"},
    {"id":"37091","name":"Phoxim (Extension to sheep): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/756/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/phoxim-extension-sheep-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37092","name":"Collaboration with academia to be reinforced","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"EMA/201401/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/collaboration-academia-be-reinforced_en.pdf"},
    {"id":"37093","name":"EU/3/15/1456: Public summary of positive opinion for orphan designation of recombinant human club cell 10 KDa protein for the prevention of bronchopulmonary dysplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/123186/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151456-public-summary-positive-opinion-orphan-designation-recombinant-human-club-cell-10-kda-protein-prevention-bronchopulmonary-dysplasia_en.pdf"},
    {"id":"37094","name":"EU/3/12/1089: Public summary of opinion on orphan designation: Choline tetrathiomolybdate for the treatment of Wilson’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2015-03-11T01:00:00Z","reference_number":"EMA/COMP/795268/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121089-public-summary-opinion-orphan-designation-choline-tetrathiomolybdate-treatment-wilsons-disease_en.pdf"},
    {"id":"37097","name":"EMEA workshop on the requirements and provision of analytical methods for drug residue control in animal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2000-02-15T01:00:00Z","last_updated_date":"2000-02-15T01:00:00Z","reference_number":"EMEA/V/3362/00","document_url":"https://www.ema.europa.eu/en/documents/other/emea-workshop-requirements-and-provision-analytical-methods-drug-residue-control-animal-products_en.pdf"},
    {"id":"37098","name":"Presentation - Working group 6: educational training of research staff involved in paediatric clinical trials / GCP training across multispecialty and countries (G. Veal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T17:36:00Z","last_updated_date":"2018-06-18T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-6-educational-training-research-staff-involved-paediatric-clinical-trials-gcp-training-across-multispecialty-and-countries-g-veal_en.pdf"},
    {"id":"37101","name":"Benefit-risk methodology project: Update on work package 5: Effects table pilot (Phase I)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-02-24T16:40:00Z","last_updated_date":"2014-02-24T16:40:00Z","reference_number":"EMA/74168/2014","document_url":"https://www.ema.europa.eu/en/documents/report/benefit-risk-methodology-project-update-work-package-5-effects-table-pilot-phase-i_en.pdf"},
    {"id":"37102","name":"Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-05T10:20:00Z","last_updated_date":"2017-12-05T10:20:00Z","reference_number":"EMA/799933/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-iv-formulation-list-nationally-authorised-medicinal-products-psusa00002311201705_en.pdf"},
    {"id":"37103","name":"Short-acting beta-agonists Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/PRAC/74483/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/short-acting-beta-agonists-article-31-referral-prac-list-questions_en.pdf"},
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    {"id":"37108","name":"Presentation - ERNs and research: state of play from the European Commission\n\nperspective - 'Snapshot' of ERNs and medicinal product point of view (Anneli Torronen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-erns-and-research-state-play-european-commission-perspective-snapshot-erns-and-medicinal-product-point-view-anneli-torronen_en.pdf"},
    {"id":"37110","name":"DOR BIOPHARMA UK Ltd withdraws marketing authorisation application for orBec (beclomethasone dipropionate)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-05-23T02:00:00Z","last_updated_date":"2008-05-23T02:00:00Z","reference_number":"EMEA/CHMP/274727/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/dor-biopharma-uk-ltd-withdraws-marketing-authorisation-application-orbec-beclomethasone-dipropionate_en.pdf"},
    {"id":"37111","name":"CHMP post-authorisation summary of positive opinion for Gardasil","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2010-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-gardasil_en.pdf-0"},
    {"id":"37115","name":"CPMP position statement on West Nile virus and plasma-derived medicinal products","type":"position","status":"Adopted","consultation_date":"","first_published_date":"2003-07-25T02:00:00Z","last_updated_date":"2003-07-25T02:00:00Z","reference_number":"EMEA/CPMP/BWP/3752/03/adopted","document_url":"https://www.ema.europa.eu/en/documents/position/cpmp-position-statement-west-nile-virus-and-plasma-derived-medicinal-products_en.pdf"},
    {"id":"37117","name":"Withdrawal assessment report for Vitragan","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-08-23T02:00:00Z","last_updated_date":"2007-08-23T02:00:00Z","reference_number":"EMEA/CHMP/226682/2007","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-vitragan_en.pdf"},
    {"id":"37119","name":"Final ICH Concept Paper for Topic E16: Pharmacogenomic (PG) biomarker qualification: format and data standards","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-06-16T02:00:00Z","last_updated_date":"2008-06-16T02:00:00Z","reference_number":"EMEA/CHMP/190395/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/final-ich-concept-paper-topic-e16-pharmacogenomic-pg-biomarker-qualification-format-and-data-standards_en.pdf"},
    {"id":"37121","name":"EU/3/16/1811: Public summary of opinion on orphan designation: 5-Aminolevulinic acid for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/14622/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161811-public-summary-opinion-orphan-designation-5-aminolevulinic-acid-treatment-glioma_en.pdf"},
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    {"id":"37124","name":"Salmeterol: List of nationally authorised medicinal products - PSUSA/00002681/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T12:00:00Z","last_updated_date":"2016-10-18T11:56:07Z","reference_number":"EMA/478258/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/salmeterol-list-nationally-authorised-medicinal-products-psusa00002681201510_en.pdf"},
    {"id":"37126","name":"EU/3/00/010: Public summary of positive opinion for orphan designation of anagrelide hydrochloride for the treatment of essential thrombocythaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2017-02-08T01:00:00Z","reference_number":"EMEA/COMP/237387/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu300010-public-summary-positive-opinion-orphan-designation-anagrelide-hydrochloride-treatment-essential-thrombocythaemia_en.pdf"},
    {"id":"37129","name":"Codeine Article-31 referral - PRAC recommends restrictions on the use of codeine for cough and cold in children","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/163792/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-prac-recommends-restrictions-use-codeine-cough-and-cold-children_en.pdf"},
    {"id":"37135","name":"International Generic Drug Regulators Programme information sharing pilot","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-01-19T15:00:00Z","last_updated_date":"2015-01-19T15:00:00Z","reference_number":"EMA/789664/2014","document_url":"https://www.ema.europa.eu/en/documents/other/international-generic-drug-regulators-programme-information-sharing-pilot_en.pdf"},
    {"id":"37137","name":"Presentation - Type-2 diabetes in children and adolescents (William Tamborlane)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-type-2-diabetes-children-and-adolescents-william-tamborlane_en.pdf"},
    {"id":"37139","name":"Report on the international Active Pharmaceutical Ingredient (API) inspection programme 2011-2016","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-04-12T16:00:00Z","last_updated_date":"2018-04-12T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-international-active-pharmaceutical-ingredient-api-inspection-programme-2011-2016_en.pdf"},
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    {"id":"37144","name":"Urofollitropin : List of nationally authorised medicinal products - PSUSA/00003082/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T15:02:00Z","last_updated_date":"2017-12-01T15:07:02Z","reference_number":"EMA/797651/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/urofollitropin-list-nationally-authorised-medicinal-products-psusa00003082201703_en.pdf"},
    {"id":"37145","name":"Overview of comments received on reflection paper on antimicrobial resistance surveillance as postmarketing authorisation commitment (EMEA/CVMP/SAGAM/428938/2007)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-10-21T02:00:00Z","last_updated_date":"2008-10-21T02:00:00Z","reference_number":"MEA/CVMP/SAGAM/341254/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-antimicrobial-resistance-surveillance-postmarketing-authorisation-commitment-emeacvmpsagam4289382007_en.pdf"},
    {"id":"37146","name":"Submission form for comments on Policy 70: Publication and access to clinical-trial data","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-06-24T16:00:00Z","last_updated_date":"2013-06-24T16:00:00Z","reference_number":"EMA/240810/2013","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-form-comments-policy-70-publication-and-access-clinical-trial-data_en.doc"},
    {"id":"37148","name":"CHMP post-authorisation summary of positive opinion for Ameluz","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/485818/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ameluz_en.pdf-0"},
    {"id":"37149","name":"European Medicines Agency launches new database of European experts","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-09-30T14:15:05Z","last_updated_date":"2011-09-30T14:15:05Z","reference_number":"EMA/794549/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-new-database-european-experts_en.pdf"},
    {"id":"37150","name":"Presentation - Population pharmacokinetics/pharmacodynamics in paediatrics: A perspective on the way forward","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-population-pharmacokineticspharmacodynamics-paediatrics-perspective-way-forward_en.pdf"},
    {"id":"37153","name":"Committee for medicinal products for veterinary use summary of opinion: Netvax: Clostridium perfringens type A toxoid","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-02-13T01:09:21Z","last_updated_date":"2014-06-11T02:09:21Z","reference_number":"EMEA/CVMP/685574/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-netvax-clostridium-perfringens-type-toxoid_en.pdf"},
    {"id":"37154","name":"CHMP summary of opinion for Emtricitabine/Tenofovir disoproxil Zentiva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-09-16T02:00:00Z","reference_number":"EMA/CHMP/596525/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-emtricitabinetenofovir-disoproxil-zentiva_en.pdf"},
    {"id":"37155","name":"Presentation - Guidance to patients and consumers on medication-error reporting (Kaisa Immonen-Charalambous)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-patients-and-consumers-medication-error-reporting-kaisa-immonen-charalambous_en.pdf"},
    {"id":"37156","name":"EU/3/07/519: Public summary of positive opinion for orphan designation of maribavir for the prevention of cytomegalovirus (CMV) disease in patients with impaired cell mediated immunity deemed at risk","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2011-05-31T02:00:00Z","reference_number":"EMEA/COMP/157555/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307519-public-summary-positive-opinion-orphan-designation-maribavir-prevention-cytomegalovirus-cmv-disease-patients-impaired-cell-mediated-immunity-deemed-risk_en.pdf"},
    {"id":"37157","name":"Agenda - CAT agenda of the 14-16 March 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-03-15T15:00:00Z","last_updated_date":"2018-03-15T15:00:00Z","reference_number":"EMA/CAT/168481/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-14-16-march-2018-meeting_en.pdf"},
    {"id":"37159","name":"Hearing the Association of the European Self-Medication Industry during the May 2015 Working Party on Community Monographs and Community List meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-08-19T15:34:00Z","last_updated_date":"2015-08-19T15:34:00Z","reference_number":"EMA/HMPC/399737/2015","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-during-may-2015-working-party-community-monographs-and-community-list-meeting_en.pdf"},
    {"id":"37161","name":"Agenda - Workshop on medicines for bees","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2009-11-27T00:09:21Z","last_updated_date":"2010-02-23T00:09:21Z","reference_number":"EMEA/627614/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-medicines-bees_en.pdf"},
    {"id":"37163","name":"Questions and answers on the withdrawal of the marketing-authorisation application for Belviq","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/309180/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-belviq_en.pdf"},
    {"id":"37165","name":"Presentation - β-Lactamase inhibitors properties, microbiology and enzymology (David Livermore)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-16T15:00:00Z","last_updated_date":"2016-03-16T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-i2-lactamase-inhibitors-properties-microbiology-and-enzymology-david-livermore_en.pdf"},
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    {"id":"37178","name":"Apramycin: Summary report (2) Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-01-01T01:00:00Z","last_updated_date":"1999-01-01T01:00:00Z","reference_number":"EMEA/MRL/526/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/apramycin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"37181","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 18-21 July 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T16:00:00Z","last_updated_date":"2016-07-27T16:00:00Z","reference_number":"EMA/76613/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-18-21-july-2016_en.pdf"},
    {"id":"37183","name":"Reflection paper on the publication of the CVMP’s negative opinion and refusal to recommend the granting of a marketing authorisation for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-07-12T02:00:00Z","last_updated_date":"2007-07-12T02:00:00Z","reference_number":"EMEA/CVMP/459912/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-publication-cvmps-negative-opinion-and-refusal-recommend-granting-marketing-authorisation-veterinary-medicinal-products_en.pdf"},
    {"id":"37186","name":"Baxter dialysis solutions Article-31 referral - Annex I (Castlebar site)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/baxter-dialysis-solutions-article-31-referral-annex-i-castlebar-site_sv.pdf"}},
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    {"id":"37192","name":"European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-16T14:00:00Z","last_updated_date":"2014-08-11T16:00:00Z","reference_number":"EMA/231414/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-alerts-eu-healthcare-professionals-after-vials-falsified-herceptin-identified_en.pdf"},
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    {"id":"37200","name":"Applicant’s consent to share assessment and inspection documents with non-European Union (EU) regulatory authorities template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T18:30:00Z","last_updated_date":"2016-03-30T18:30:00Z","reference_number":"EMA/801202/2015","document_url":"https://www.ema.europa.eu/en/documents/template-form/applicants-consent-share-assessment-and-inspection-documents-non-european-union-eu-regulatory-authorities-template_en.doc"},
    {"id":"37201","name":"EU/3/01/060: Public summary of positive opinion for orphan designation of pemetrexed disodium for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-03T00:00:00Z","last_updated_date":"2011-05-07T01:00:00Z","reference_number":"EMEA/COMP/1294/03draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301060-public-summary-positive-opinion-orphan-designation-pemetrexed-disodium-treatment-malignant-mesothelioma_en.pdf"},
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    {"id":"37207","name":"29th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-11-22T00:09:21Z","last_updated_date":"2002-11-22T00:09:21Z","reference_number":"EMEA/COMP/2792/02/corr.","document_url":"https://www.ema.europa.eu/en/documents/press-release/29th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"37211","name":"Declaration of interests: Stefan Blixen-Finecke","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-09-12T02:00:00Z","last_updated_date":"2019-10-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-stefan-blixen-finecke_en.pdf"},
    {"id":"37212","name":"Presentation - Paediatric Pharmacovigilance of biologicals - a myth or a challenge","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-03-22T01:00:00Z","last_updated_date":"2011-03-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-pharmacovigilance-biologicals-myth-or-challenge_en.pdf"},
    {"id":"37213","name":"Euphrasia officinalis: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/667/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/euphrasia-officinalis-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37214","name":"Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T13:00:00Z","last_updated_date":"2018-03-09T13:00:00Z","reference_number":"EMA/146483/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/prostate-cancer-medicine-xofigo-must-not-be-used-zytiga-and-prednisoneprednisolone_en.pdf"},
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    {"id":"37218","name":"EU/3/11/868: Public summary of opinion on orphan designation: Lenalidomide for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-05-30T02:00:00Z","last_updated_date":"2011-05-30T02:00:00Z","reference_number":"EMA/COMP/156241/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311868-public-summary-opinion-orphan-designation-lenalidomide-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"37222","name":"Ergot derivatives Article-31 referral - Dihydroergotoxine - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iv_sv.pdf"}},
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    {"id":"37225","name":"Overview of comments received on draft guideline on radiopharmaceuticals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-26T01:00:00Z","last_updated_date":"2008-11-26T01:00:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/567962/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-radiopharmaceuticals_en.pdf"},
    {"id":"37227","name":"Presentation - Organ failure scores in neonatal sepsis (Hugo Devlieger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-organ-failure-scores-neonatal-sepsis-hugo-devlieger_en.pdf"},
    {"id":"37228","name":"PRAC recommends restrictions on the use of codeine for cough and cold in children","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-03-13T01:00:00Z","last_updated_date":"2015-03-13T01:00:00Z","reference_number":"EMA/163792/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-restrictions-use-codeine-cough-and-cold-children_en.pdf"},
    {"id":"37230","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-10-18T13:30:00Z","last_updated_date":"2012-10-18T13:30:00Z","reference_number":"EMA/CAT/608504/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-october-2012-meeting_en.pdf"},
    {"id":"37231","name":"Flumequine (Extension to all food producing species): Summary report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/MRL/823/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flumequine-extension-all-food-producing-species-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37233","name":"Presentation - Case studies and questions and answers - Session 3 (Nancy Cauwenberghs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-studies-and-questions-and-answers-session-3-nancy-cauwenberghs_en.pdf"},
    {"id":"37234","name":"Presentation - Pharmacovigilance requirements for Member States (June M Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-requirements-member-states-june-m-raine_en.pdf"},
    {"id":"37235","name":"Presentation - Improving processes: referrals as a case study (Ulla Wandel Liminga)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-29T18:30:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-improving-processes-referrals-case-study-ulla-wandel-liminga_en.pdf"},
    {"id":"37236","name":"Presentation - Outcomes from break-out session 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outcomes-break-out-session-2_en.pdf"},
    {"id":"37237","name":"Presentation - Session 2.4: Working group on interactions networks-industry-regulators (Susan Tansey, Pirkko Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-24-working-group-interactions-networks-industry-regulators-susan-tansey-pirkko-lepola_en.pdf"},
    {"id":"37238","name":"Regulatory and methodological standards to improve benefit-risk evaluation of medicines - Workshop report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"EMA/141854/2014","document_url":"https://www.ema.europa.eu/en/documents/report/regulatory-and-methodological-standards-improve-benefit-risk-evaluation-medicines-workshop-report_en.pdf"},
    {"id":"37239","name":"Overview of comments received on draft guideline on selection of test materials for genotoxicity testing for Traditional Herbal Medicinal Products/Herbal Medicinal Products","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-01-18T01:00:00Z","last_updated_date":"2010-01-18T01:00:00Z","reference_number":"EMEA/HMPC/651266/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-selection-test-materials-genotoxicity-testing-traditional-herbal-medicinal-productsherbal-medicinal-products_en.pdf"},
    {"id":"37241","name":"Presentation - FVE viewpoint on draft ESVAC strategy 2016-2020","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T17:00:00Z","last_updated_date":"2016-03-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fve-viewpoint-draft-esvac-strategy-2016-2020_en.pdf"},
    {"id":"37242","name":"Mometasone Furoate Sandoz - Article-29(4) referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-01-24T01:00:00Z","last_updated_date":"2013-01-24T01:00:00Z","reference_number":"EMA/CHMP/573035/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/mometasone-furoate-sandoz-article-294-referral-assessment-report_en.pdf"},
    {"id":"37243","name":"Penciclovir: List of nationally authorised medicinal products - PSUSA/00002333/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-23T19:23:00Z","last_updated_date":"2017-05-23T19:24:30Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/penciclovir-list-nationally-authorised-medicinal-products-psusa00002333201608_en.pdf"},
    {"id":"37246","name":"Superseded Community herbal monograph on Rhamnus purshianus D.C., cortex","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-09-07T02:09:00Z","last_updated_date":"2007-09-07T02:09:00Z","reference_number":"EMEA/HMPC/513579/2006Corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-rhamnus-purshianus-dc-cortex_en.pdf"},
    {"id":"37249","name":"Questions and answers on benzalkonium chloride used as an excipient in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/495737/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-benzalkonium-chloride-used-excipient-medicinal-products-human-use_en.pdf"},
    {"id":"37250","name":"Survey 2008 on the performance of EMEA scientific procedures for\n\nmedicinal products for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-03-05T00:00:00Z","last_updated_date":"2009-03-05T00:00:00Z","reference_number":"EMEA/MB/30754/2009","document_url":"https://www.ema.europa.eu/en/documents/other/survey-2008-performance-emea-scientific-procedures-medicinal-products-human-use_en.pdf"},
    {"id":"37253","name":"Opinion of the HMPC on a European Union herbal monograph on Crataegus spp., folium cum flore","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/HMPC/244297/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"37257","name":"Comments received from public consultation on good pharmacovigilance practices: GVP module XVI - Risk minimisation measures - Selection of tools and effectiveness indicators","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T10:30:00Z","last_updated_date":"2014-02-28T10:30:00Z","reference_number":"EMA/72273/2014","document_url":"https://www.ema.europa.eu/en/documents/other/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-module-xvi-risk-minimisation-measures-selection-tools-and-effectiveness-indicators_en.pdf"},
    {"id":"37258","name":"Opinion of the CVMP on the establishment of maximum residue limits: Methylprednisolone","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-10-26T19:38:54Z","last_updated_date":"2010-10-26T19:38:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-methylprednisolone_en.pdf-0"},
    {"id":"37259","name":"Human coagulation factor VIII / human von Willebrand factor: List of nationally authorised products - PSUSA/00001621/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-13T02:00:00Z","last_updated_date":"2016-10-17T17:15:45Z","reference_number":"EMA/406234/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-coagulation-factor-viii-human-von-willebrand-factor-list-nationally-authorised-products-psusa00001621201510_en.pdf"},
    {"id":"37260","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Oxervate (cenegermin) for the treatment neurotrophic keratitis","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2017-08-29T16:08:00Z","last_updated_date":"2017-08-29T16:08:00Z","reference_number":"EMA/337473/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-oxervate-cenegermin-treatment-neurotrophic-keratitis_en.pdf"},
    {"id":"37261","name":"Presentation - Industry experience with ethical review of paediatric trials: Result of survey by the European Contract Research Organisation Foundation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-experience-ethical-review-paediatric-trials-result-survey-european-contract-research-organisation-foundation_en.pdf"},
    {"id":"37263","name":"Superseded final assessment report on Plantago afra L., et Plantago indica L., semen","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-02-28T00:09:21Z","last_updated_date":"2013-07-29T14:00:00Z","reference_number":"EMEA/HMPC/167338/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-final-assessment-report-plantago-afra-l-et-plantago-indica-l-semen_en.pdf"},
    {"id":"37265","name":"Cetirizine / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00000629/201608","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-30T17:15:00Z","last_updated_date":"2017-06-30T17:15:00Z","reference_number":"EMA/405164/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cetirizine-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa00000629201608_en.pdf"},
    {"id":"37267","name":"Ancillary - Day 180 JAR Overview template rev.10.16","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-05-10T12:00:00Z","last_updated_date":"2016-11-08T11:26:00Z","reference_number":"rev.10.16","document_url":"https://www.ema.europa.eu/en/documents/template-form/ancillary-day-180-jar-overview-template-rev1016_en.doc"},
    {"id":"37268","name":"Novartis Vaccines and Diagnostics S.r.l. withdraws its marketing\n\nauthorisation application for the pre-pandemic vaccine Aflunov","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-06-16T02:00:00Z","last_updated_date":"2008-06-16T02:00:00Z","reference_number":"EMEA/306734/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/novartis-vaccines-and-diagnostics-srl-withdraws-its-marketing-authorisation-application-pre-pandemic-vaccine-aflunov_en.pdf"},
    {"id":"37271","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - July 2005","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-07-31T02:00:00Z","last_updated_date":"2005-07-31T02:00:00Z","reference_number":"EMEA/252976/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-july-2005_en.pdf"},
    {"id":"37273","name":"CHMP ORGAM agenda for the meeting on 16 April 2018","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T13:00:00Z","last_updated_date":"2018-05-03T13:00:00Z","reference_number":"EMA/CHMP/237329/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-16-april-2018_en.pdf"},
    {"id":"37274","name":"Guidelines and concept papers adopted during the CHMP meeting 18-21 February 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-02-28T13:45:00Z","last_updated_date":"2013-02-28T13:45:00Z","reference_number":"EMA/CHMP/109941/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-18-21-february-2013_en.pdf"},
    {"id":"37275","name":"CHMP post-authorisation summary of positive opinion for Votubia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/543900/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-votubia_en.pdf-1"},
    {"id":"37277","name":"Navigating the regulatory maze - Marisa Papaluca","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/navigating-regulatory-maze-marisa-papaluca_en.pdf"},
    {"id":"37279","name":"Presentation - Study design and analysis in late-stage cancer immunotherapy trials (Tai-Tsang Chen) - S5.2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-study-design-and-analysis-late-stage-cancer-immunotherapy-trials-tai-tsang-chen-s52_en.pdf"},
    {"id":"37280","name":"Agenda - Training session on the review of product information 29/11/11","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-11-23T01:00:00Z","last_updated_date":"2011-11-23T01:00:00Z","reference_number":"EMA/818489/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-review-product-information-291111_en.pdf"},
    {"id":"37281","name":"Summary of transfer of appropriations in the budget 2013 - Management Board meeting: 11-12 December 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-12-17T11:30:00Z","last_updated_date":"2013-12-17T11:30:00Z","reference_number":"EMA/MB/703501/2013 Noted","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2013-management-board-meeting-11-12-december-2013_en.pdf"},
    {"id":"37282","name":"Linguistic aspects, A Skarlatos, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/linguistic-aspects-skarlatos-ema_en.pdf"},
    {"id":"37283","name":"Guideline on data monitoring committees","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-07-27T02:00:00Z","last_updated_date":"2005-07-27T02:00:00Z","reference_number":"EMEA/CHMP/EWP/5872/03 Corr","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf"},
    {"id":"37289","name":"Superseded community herbal monograph on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2007-05-08T02:09:21Z","last_updated_date":"2015-03-13T01:09:21Z","reference_number":"EMEA/HMPC/260019/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"37290","name":"Tylosin Article-35 referral - Questions and answers on veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma 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    {"id":"37320","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n19-22 January 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T00:09:21Z","last_updated_date":"2009-01-22T00:09:21Z","reference_number":"EMEA/37933/2009 - corr","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-19-22-january-2009_en.pdf"},
    {"id":"37322","name":"Superseded assessment report on Gentiana Lutea L., radix  - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-03-05T01:00:00Z","last_updated_date":"2019-04-30T01:00:00Z","reference_number":"EMA/HMPC/578322/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-gentiana-lutea-l-radix-first-version_en.pdf"},
    {"id":"37323","name":"Registration form - European Medicines Agency/International Federation for Animal Health-Europe info day 2015","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T17:00:00Z","last_updated_date":"2015-01-22T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-european-medicines-agencyinternational-federation-animal-health-europe-info-day-2015_en.doc"},
    {"id":"37324","name":"Combined hormonal contraceptives: Article-31 referral - Timetable for the procedure","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T13:00:00Z","last_updated_date":"2013-07-12T17:30:00Z","reference_number":"EMA/PRAC/122032/2013 - Rev 3","document_url":"https://www.ema.europa.eu/en/documents/referral/combined-hormonal-contraceptives-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"37325","name":"Presentation - Role of real world evidence to foster access to innovative diabetes medicine (Agathe Le Lay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-real-world-evidence-foster-access-innovative-diabetes-medicine-agathe-le-lay_en.pdf"},
    {"id":"37326","name":"Sanofi-aventis withdraws its marketing authorisation application for\n\nAquilda (satavaptan)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-05-28T02:00:00Z","last_updated_date":"2008-05-28T02:00:00Z","reference_number":"EMEA/CHMP/277714/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/sanofi-aventis-withdraws-its-marketing-authorisation-application-aquilda-satavaptan_en.pdf"},
    {"id":"37328","name":"Arimidex 1 mg film-coated tablet - Artical 29 Paediatrics referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/arimidex-1-mg-film-coated-tablet-artical-29-paediatrics-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"37330","name":"Annual report 2010 (Annexes)","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2011-06-29T02:00:00Z","last_updated_date":"2011-06-29T02:00:00Z","reference_number":"EMA/457721/2011","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-2010-annexes_en.pdf"},
    {"id":"37332","name":"Marbofloxacin: Summary report  (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-10-01T02:00:00Z","last_updated_date":"1999-10-01T02:00:00Z","reference_number":"EMEA/MRL/693/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/marbofloxacin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"37342","name":"Presentation - A systems pharmacology perspective on the clinical development of fatty acid amide hydrolase inhibitors for pain (Piet van der Graaf)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-systems-pharmacology-perspective-clinical-development-fatty-acid-amide-hydrolase-inhibitors-pain-piet-van-der-graaf_en.pdf"},
    {"id":"37343","name":"Committee for Proprietary Medicinal Products (CPMP): meeting of 16 to 18 October 2001","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-10-19T02:09:21Z","last_updated_date":"2001-10-19T02:09:21Z","reference_number":"EMEA/CPMP/3297/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-proprietary-medicinal-products-cpmp-meeting-16-18-october-2001_en.pdf"},
    {"id":"37344","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 21-22 November 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-12-15T10:00:00Z","last_updated_date":"2016-12-15T10:00:00Z","reference_number":"EMA/HMPC/798592/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-21-22-november-2016_en.pdf"},
    {"id":"37346","name":"Committee for Medicinal Products for Veterinary Use (CVMP) monthly report of application procedures, guidelines and related documents: June  2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-07-25T13:00:00Z","last_updated_date":"2012-07-25T13:00:00Z","reference_number":"EMA/343346/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-june-2012_en.pdf"},
    {"id":"37347","name":"Presentation - European Multiple Sclerosis Platform (EMSP) - EMA's PCWP and HCPWP joint meeting (Andreea Antonovici)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-multiple-sclerosis-platform-emsp-emas-pcwp-and-hcpwp-joint-meeting-andreea-antonovici_en.pdf"},
    {"id":"37349","name":"Questions and answers on the benefits and risks of rosiglitazone and pioglitazone","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-10-18T02:00:00Z","last_updated_date":"2007-10-18T02:00:00Z","reference_number":"EMEA/484464/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-benefits-and-risks-rosiglitazone-and-pioglitazone_en.pdf"},
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    {"id":"37357","name":"Pharmaceutical Industry Perspective: Dr. Catarina Edfjà¤ll","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/pharmaceutical-industry-perspective-dr-catarina-edfjall_en.pdf"},
    {"id":"37358","name":"Final list of references supporting the assessment of Sambucus nigra L. - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-06-27T17:00:00Z","last_updated_date":"2018-06-27T17:00:00Z","reference_number":"EMA/HMPC/611509/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-sambucus-nigra-l-revision-1_en.pdf"},
    {"id":"37361","name":"EFPIA position on CHMP work programme: Evaluation of risk benefit - Scientific Advisory Groups","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/efpia-position-chmp-work-programme-evaluation-risk-benefit-scientific-advisory-groups_en.pdf"},
    {"id":"37364","name":"Overview of comments received on 'reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical samples'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-17T15:45:00Z","last_updated_date":"2012-02-17T15:45:00Z","reference_number":"EMA/INS/GCP/219642/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-guidance-laboratories-perform-analysis-or-evaluation-clinical-samples_en.pdf"},
    {"id":"37365","name":"Wormwood herb : Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-10-02T18:33:00Z","last_updated_date":"2017-10-02T18:33:00Z","reference_number":"EMA/366468/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/wormwood-herb-summary-public_en.pdf"},
    {"id":"37367","name":"Concept paper on development of a CPMP points to consider on xenogeneic cell therapy","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2000-11-16T01:00:00Z","last_updated_date":"2000-11-16T01:00:00Z","reference_number":"CPMP/BWP/3326/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-cpmp-points-consider-xenogeneic-cell-therapy_en.pdf"},
    {"id":"37368","name":"Minutes of the 2016 annual meeting of Enpr-EMA members - 3 June 2016","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T13:45:00Z","last_updated_date":"2016-10-28T13:45:00Z","reference_number":"EMA/520986/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-2016-annual-meeting-enpr-ema-members-3-june-2016_en.pdf"},
    {"id":"37370","name":"Outcome of small and medium-sized enterprise (SME) office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T17:38:23Z","last_updated_date":"2011-12-21T17:38:23Z","reference_number":"EMA/733642/2011","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-small-and-medium-sized-enterprise-sme-office-survey-implementation-sme-regulation-commission-regulation-ec-no-20492005_en.pdf"},
    {"id":"37371","name":"EU/3/17/1912: Public summary of opinion on orphan designation: Tacrolimus for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/495732/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171912-public-summary-opinion-orphan-designation-tacrolimus-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"37374","name":"EU/3/16/1773: Public summary of positive opinion for orphan designation of allogenic cytomegalovirus-specific cytotoxic T lymphocytes for the treatment of cytomegalovirus infections in patients with impaired cell-mediate...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-13T15:43:00Z","last_updated_date":"2022-09-16T15:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161773-public-summary-positive-opinion-orphan-designation-allogenic-cytomegalovirus-specific-cytotoxic-t-lymphocytes-treatment-cytomegalovirus-infections-patients-impaired-cell-mediate_en.pdf"},
    {"id":"37377","name":"Opinion of the HMPC on a European Union herbal monograph on Salvia officinalis L., folium - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2017-07-13T02:00:00Z","last_updated_date":"2017-07-13T02:00:00Z","reference_number":"EMA/HMPC/531445/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-salvia-officinalis-l-folium-revision-1_en.pdf"},
    {"id":"37379","name":"Presentation - Application of physiologically-based pharmacokinetic modeling to support dosing recommendations – The US Food and Drug Administration Experience (Ping Zhao)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-application-physiologically-based-pharmacokinetic-modeling-support-dosing-recommendations-us-food-and-drug-administration-experience-ping-zhao_en.pdf"},
    {"id":"37380","name":"EU/3/06/411: Public summary of positive opinion for orphan designation of recombinant fusion protein consisting of the extracellular portion of CD95 fused to the Fc part of a human IgG1 molecule for the prevention of gra...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2009-04-02T02:00:00Z","reference_number":"EMEA/COMP/200084/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306411-public-summary-positive-opinion-orphan-designation-recombinant-fusion-protein-consisting-extracellular-portion-cd95-fused-fc-part-human-igg1-molecule-prevention-gra_en.pdf"},
    {"id":"37381","name":"CHMP post-authorisation summary of positive opinion for Xiliarx","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/600947/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xiliarx_en.pdf-0"},
    {"id":"37382","name":"CHMP post-authorisation summary of positive opinion for Tesavel of 24 September 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/546109/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tesavel-24-september-2009_en.pdf"},
    {"id":"37385","name":"European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products 18-20 November 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-11-20T00:09:21Z","last_updated_date":"2003-11-20T00:09:21Z","reference_number":"EMEA/CPMP/5732/03/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-18-20-november-2003_en.pdf"},
    {"id":"37386","name":"Ceftriaxone: List of nationally authorised medicinal products - PSUSA/00000613/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-10-18T15:41:14Z","reference_number":"EMA/72827/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/ceftriaxone-list-nationally-authorised-medicinal-products-psusa00000613201505_en.pdf"},
    {"id":"37387","name":"CHMP summary of positive opinion for Eurartesim","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-06-24T02:00:00Z","last_updated_date":"2011-06-24T02:00:00Z","reference_number":"EMA/CHMP/207988/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eurartesim_en.pdf"},
    {"id":"37390","name":"GVK Biosciences Article-31 referral - CHMP list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/590962/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-chmp-list-questions_en.pdf"},
    {"id":"37391","name":"Guideline on the evaluation of medicinal products in the treatment of primary osteoporosis","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-11-16T01:00:00Z","last_updated_date":"2006-11-16T01:00:00Z","reference_number":"CPMP/EWP/552/95 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-medicinal-products-treatment-primary-osteoporosis_en.pdf"},
    {"id":"37393","name":"Overview of comments received on 'guideline on similar biological medicinal products containing monoclonal antibodies' (EMA/CHMP/BMWP/403543/2010)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:42Z","last_updated_date":"2012-06-15T17:10:42Z","reference_number":"EMA/205886/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-emachmpbmwp4035432010_en.pdf"},
    {"id":"37397","name":"EU/3/09/696: Public summary of positive opinion for orphan designation of\n\nhuman MHC non-restricted cytotoxic T-cell line for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-12-08T00:09:21Z","last_updated_date":"2013-06-19T14:00:00Z","reference_number":"EMEA/COMP/652787/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309696-public-summary-positive-opinion-orphan-designation-human-mhc-non-restricted-cytotoxic-t-cell-line-treatment-ovarian-cancer_en.pdf"},
    {"id":"37399","name":"Summary on compassionate use for IV Zanamivir (Rev. 1)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-07-12T02:00:00Z","reference_number":"EMA/CHMP/40488/2010","document_url":"https://www.ema.europa.eu/en/documents/other/summary-compassionate-use-iv-zanamivir-rev-1_en.pdf"},
    {"id":"37402","name":"Acetylisovaleryltylosin: Summary Report (4) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2005-03-01T01:00:00Z","last_updated_date":"2005-03-01T01:00:00Z","reference_number":"EMEA/CVMP/77339/2005-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/acetylisovaleryltylosin-summary-report-4-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37403","name":"Presentation - 1.2 Overview on Integrated DEsign and AnaLysis (IDeAl ) of small population group trials (Ralf-Dieter Hilgers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-12-overview-integrated-design-and-analysis-ideal-small-population-group-trials-ralf-dieter-hilgers_en.pdf"},
    {"id":"37404","name":"Presentation - Methodological issues (some) relating to patient selection -\n\nCHMP reflection paper","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-methodological-issues-some-relating-patient-selection-chmp-reflection-paper_en.pdf"},
    {"id":"37408","name":"Superseded list of references for assessment of: Boldi folium Peumus boldus Molina, folium (boldo leaf)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-01-14T00:09:21Z","last_updated_date":"2017-01-12T10:12:00Z","reference_number":"EMEA/HMPC/591649/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-assessment-boldi-folium-peumus-boldus-molina-folium-boldo-leaf_en.pdf"},
    {"id":"37410","name":"Questions and answers on the use of phosphates in eye drops","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T13:00:00Z","last_updated_date":"2012-12-14T13:00:00Z","reference_number":"EMA/CHMP/753373/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-use-phosphates-eye-drops_en.pdf"},
    {"id":"37413","name":"European Medicines Agency launches public consultation on new transparency policy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-19T02:00:00Z","last_updated_date":"2009-06-19T02:00:00Z","reference_number":"EMEA/376923/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-launches-public-consultation-new-transparency-policy_en.pdf"},
    {"id":"37414","name":"Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-07T12:15:00Z","last_updated_date":"2018-09-07T12:21:55Z","reference_number":"EMA/607287/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/tapentadol-list-nationally-authorised-medicinal-products-psusa00002849201711_en.pdf"},
    {"id":"37415","name":"Presentation: Networking of European REC's","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-networking-european-recs_en.pdf"},
    {"id":"37416","name":"Superseded assessment report on Oenothera biennis L., Oenothera lamarckiana L., oleum - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-04-02T11:26:00Z","last_updated_date":"2018-10-10T11:26:00Z","reference_number":"EMA/HMPC/277791/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-first-version_en.pdf"},
    {"id":"37418","name":"Draft list of references supporting the assessment of Vaccinium myrtillus L., fructus","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-02-09T01:00:00Z","last_updated_date":"2015-02-09T01:00:00Z","reference_number":"EMA/HMPC/678996/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-vaccinium-myrtillus-l-fructus_en.pdf-0"},
    {"id":"37419","name":"Sodium iodide (131i): List of nationally authorised medicinal products - PSUSA/00002753/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T12:20:00Z","last_updated_date":"2018-01-04T12:29:26Z","reference_number":"EMA/849048/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-iodide-131i-list-nationally-authorised-medicinal-products-psusa00002753201703_en.pdf"},
    {"id":"37420","name":"Meeting of the EMEA working party on herbal medicinal products 1 - 2 April 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-04-19T02:00:00Z","last_updated_date":"2004-04-19T02:00:00Z","reference_number":"EMEA/HMPWP/1513/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-emea-working-party-herbal-medicinal-products-1-2-april-2004_en.pdf"},
    {"id":"37421","name":"CHMP summary of positive opinion for Mysildecard","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-08-03T02:00:00Z","last_updated_date":"2016-08-03T02:00:00Z","reference_number":"EMA/485582/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mysildecard_en.pdf"},
    {"id":"37422","name":"Standard operating procedure for handling invoice payment within deadline of 30 days (standard payments)","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2013-01-03T17:00:01Z","last_updated_date":"2015-02-17T14:00:00Z","reference_number":"SOP/EMA/0135","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-handling-invoice-payment-within-deadline-30-days-standard-payments_en.pdf"},
    {"id":"37423","name":"Questions and answers on the withdrawal of the marketing application for\n\nOrplatna","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-10-17T02:00:00Z","last_updated_date":"2008-10-17T02:00:00Z","reference_number":"EMEA/404511/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-orplatna_sv.pdf"}},
    {"id":"37424","name":"Medication-errors workshop - List of participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-13T12:30:00Z","last_updated_date":"2013-05-13T12:30:00Z","reference_number":"EMA/109271/2013","document_url":"https://www.ema.europa.eu/en/documents/other/medication-errors-workshop-list-participants_en.pdf"},
    {"id":"37425","name":"EU/3/09/664: Public summary of positive opinion for orphan designation of allogeneic ex-vivo-expanded umbilical-cord blood cells for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2015-05-08T02:00:00Z","reference_number":"EMEA/COMP/467478/2009 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309664-public-summary-positive-opinion-orphan-designation-allogeneic-ex-vivo-expanded-umbilical-cord-blood-cells-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"37426","name":"Vismodegib hard capsule 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-08-03T14:00:00Z","last_updated_date":"2018-08-03T14:00:00Z","reference_number":"EMA/CHMP/800794/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vismodegib-hard-capsule-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"37427","name":"Prulifloxacin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation -PSUSA/00002569/201410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-11T12:00:00Z","last_updated_date":"2016-10-17T18:59:00Z","reference_number":"EMA/517095/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/prulifloxacin-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002569201410_en.pdf"},
    {"id":"37428","name":"Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2012-06-15T17:10:00Z","last_updated_date":"2012-06-15T17:10:00Z","reference_number":"EMA/CHMP/BMWP/403543/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical-and-clinical-issues_en.pdf"},
    {"id":"37430","name":"European Risk Management Strategy: 2008-2009 work programme adopted","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-12-20T01:00:00Z","last_updated_date":"2007-12-20T01:00:00Z","reference_number":"EMEA/564868/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-risk-management-strategy-2008-2009-work-programme-adopted_en.pdf"},
    {"id":"37432","name":"Final assessment report on Vitis vinifera L., folium - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-01-05T01:00:00Z","last_updated_date":"2018-01-05T01:00:00Z","reference_number":"EMA/HMPC/464682/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-vitis-vinifera-l-folium-revision-1_en.pdf"},
    {"id":"37433","name":"Presentation - Good pharmacovigilance practices (GVP): module P-II biological medicinal products (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T16:00:00Z","last_updated_date":"2015-06-25T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-gvp-module-p-ii-biological-medicinal-products-xavier-kurz_en.pdf"},
    {"id":"37434","name":"Presentation - Management and reporting of adverse reactions to medicinal products: Good pharmacovigilance practice module VI","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-03T17:30:00Z","last_updated_date":"2012-05-03T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-management-and-reporting-adverse-reactions-medicinal-products-good-pharmacovigilance-practice-module-vi_en.pdf"},
    {"id":"37436","name":"Draft guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application (revision) - Superseded","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"EMEA/CPMP/VEG/4717/03- Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-dossier-structure-and-content-pandemic-influenza-vaccine-marketing-authorisation-application-revision-superseded_en.pdf"},
    {"id":"37441","name":"Questions and answers on COX-2 inhibitors","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2005-02-18T00:08:21Z","last_updated_date":"2005-02-18T00:08:21Z","reference_number":"EMEA/62978/2005","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-cox-2-inhibitors_en.pdf"},
    {"id":"37444","name":"Presentation - Two years of operation of the Pharmacovigilance Risk Assessment Committee (June Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-two-years-operation-pharmacovigilance-risk-assessment-committee-june-raine_en.pdf"},
    {"id":"37445","name":"CHMP summary of positive opinion for Adynovi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T01:00:00Z","last_updated_date":"2017-11-10T01:00:00Z","reference_number":"EMA/CHMP/708455/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-adynovi_en.pdf"},
    {"id":"37446","name":"Fibrin sealants Article 31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2013-04-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fibrin-sealants-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fibrin-sealants-article-31-referral-annex-ii_bg.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fibrin-sealants-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fibrin-sealants-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fibrin-sealants-article-31-referral-annex-ii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fibrin-sealants-article-31-referral-annex-ii_el.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fibrin-sealants-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fibrin-sealants-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fibrin-sealants-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fibrin-sealants-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fibrin-sealants-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fibrin-sealants-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fibrin-sealants-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fibrin-sealants-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fibrin-sealants-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fibrin-sealants-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fibrin-sealants-article-31-referral-annex-ii_sl.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fibrin-sealants-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"37447","name":"Overview of comments received on draft guideline on the development of new medicinal products for the treatment of Crohn's disease","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/492092/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-development-new-medicinal-products-treatment-crohns-disease_en.pdf"},
    {"id":"37449","name":"Presentation - EUGenMed roadmap for including sex and gender in biomedical and public health research (Hildrun Sundseth)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-10T18:30:00Z","last_updated_date":"2015-08-10T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eugenmed-roadmap-including-sex-and-gender-biomedical-and-public-health-research-hildrun-sundseth_en.pdf"},
    {"id":"37450","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Votrient (pazopanib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-04-25T02:00:00Z","last_updated_date":"2014-04-25T02:00:00Z","reference_number":"EMA/232003/2014 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-votrient-pazopanib_en.pdf"},
    {"id":"37451","name":"EU/3/18/2017: Public summary of opinion on orphan designation: Ambroxol hydrochloride for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-24T11:27:00Z","last_updated_date":"2018-07-24T11:27:00Z","reference_number":"EMA/270990/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182017-public-summary-opinion-orphan-designation-ambroxol-hydrochloride-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"37453","name":"Ammonium chloride : Summary report  Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/394/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ammonium-chloride-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37454","name":"CHMP post authorisation summary of positive opinion for Efficib of 24 September 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/CHMP/544759/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-efficib-24-september-2009_en.pdf"},
    {"id":"37455","name":"Workshop report - Developing a framework of collaboration between the European Medicines Agency (EMA) and academia","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-08-01T15:50:00Z","last_updated_date":"2016-08-01T15:50:00Z","reference_number":"EMA/424858/2016","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-developing-framework-collaboration-between-european-medicines-agency-ema-and-academia_en.pdf"},
    {"id":"37457","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous oral mucosa cells seeded onto a membrane","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-07-10T17:15:00Z","last_updated_date":"2012-07-10T17:15:00Z","reference_number":"EMA/401326/2012","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-oral-mucosa-cells-seeded-membrane_en.pdf"},
    {"id":"37458","name":"Final assessment report on Salvia officinalis L., folium and Salvia officinalis L., aetheroleum - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-07-13T02:00:00Z","last_updated_date":"2017-07-13T02:00:00Z","reference_number":"EMA/HMPC/150801/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-salvia-officinalis-l-folium-and-salvia-officinalis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"37459","name":"Committee for Medicinal Products for Human Use (CHMP) - April 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2007-05-04T02:00:00Z","last_updated_date":"2007-05-04T02:00:00Z","reference_number":"EMEA/181739/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-april-2007-plenary-meeting-monthly-report_en.pdf"},
    {"id":"37461","name":"Presentation - Collecting and reporting information on off-label use (Gilles Touraille, Sabine Brosch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-collecting-and-reporting-information-label-use-gilles-touraille-sabine-brosch_en.pdf"},
    {"id":"37462","name":"CVMP post-authorisation summary of positive opinion for Comfortis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-09-13T18:00:00Z","last_updated_date":"2023-06-26T18:00:00Z","reference_number":"EMA/CVMP/490575/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-comfortis_en.pdf-0"},
    {"id":"37464","name":"PDCO meeting report 18-20 April 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-02T02:00:00Z","last_updated_date":"2011-05-02T02:00:00Z","reference_number":"EMA/PDCO/300057/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-18-20-april-2011_en.pdf"},
    {"id":"37467","name":"Presentation - Bringing real-life experience into the evaluation of medicines (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-28T02:00:00Z","last_updated_date":"2016-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bringing-real-life-experience-evaluation-medicines-ivana-silva_en.pdf"},
    {"id":"37468","name":"Letter from European Medicines Agency to Gerard Bapt regarding Dr Xavier Kurz","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-13T03:00:00Z","last_updated_date":"2011-07-13T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-european-medicines-agency-gerard-bapt-regarding-dr-xavier-kurz_en.pdf"},
    {"id":"37469","name":"Presentation - Supporting orphan medicines development and addressing significant benefit requirements through protocol assistance (Matthias Hofer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-08T01:00:00Z","last_updated_date":"2017-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supporting-orphan-medicines-development-and-addressing-significant-benefit-requirements-through-protocol-assistance-matthias-hofer_en.pdf"},
    {"id":"37471","name":"European Medicines Agency recommends authorisation of two additional Bluetongue vaccines through the centralised procedure","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-11-27T00:09:21Z","last_updated_date":"2009-11-27T00:09:21Z","reference_number":"EMEA/733596/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-authorisation-two-additional-bluetongue-vaccines-through-centralised-procedure_en.pdf"},
    {"id":"37473","name":"Clobetasol: List of nationally authorised medicinal products - PSUSA/00000799/201502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T14:00:00Z","last_updated_date":"2016-10-17T20:16:32Z","reference_number":"EMA/707111/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/clobetasol-list-nationally-authorised-medicinal-products-psusa00000799201502_en.pdf"},
    {"id":"37476","name":"Withdrawal assessment report for Opdivo","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-12-06T16:30:00Z","last_updated_date":"2017-12-06T16:30:00Z","reference_number":"EMA/772719/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-opdivo_en.pdf"},
    {"id":"37477","name":"Minutes of the third meeting of the EMEA Human Scientific Committees’ Working Party with with Patients’ and Consumers’ Organisations (PCWP)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2007-09-24T02:00:00Z","last_updated_date":"2007-09-24T02:00:00Z","reference_number":"EMEA/439453/2007","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-third-meeting-emea-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp_en.pdf"},
    {"id":"37483","name":"European Medicines Agency holds first scientific workshop on nanomedicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-09-06T02:00:00Z","last_updated_date":"2010-09-06T02:00:00Z","reference_number":"EMA/559074/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-holds-first-scientific-workshop-nanomedicines_en.pdf"},
    {"id":"37484","name":"Committee for Medicinal Products for Human Use (CHMP) - December 2004 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-01-06T01:00:00Z","last_updated_date":"2005-01-06T01:00:00Z","reference_number":"CHMP/203834/2004","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-december-2004-plenary-meeting-monthly-report_en.pdf"},
    {"id":"37485","name":"CHMP summary of positive opinion Ebymect","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/523224/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ebymect_en.pdf"},
    {"id":"37488","name":"Position statement on the use of tumourigenic cells of human origin for the production of biological and biotechnological medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-03-01T01:00:00Z","last_updated_date":"2001-03-01T01:00:00Z","reference_number":"CPMP/BWP/1143/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-statement-use-tumourigenic-cells-human-origin-production-biological-and-biotechnological-medicinal-products_en.pdf"},
    {"id":"37492","name":"Public summary of negative opinion for orphan designation of melatonin for the treatment of partial deep dermal and full thickness burns","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T02:00:00Z","last_updated_date":"2018-04-11T02:00:00Z","reference_number":"EMA/57238/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-melatonin-treatment-partial-deep-dermal-and-full-thickness-burns_en.pdf"},
    {"id":"37493","name":"COMP report to the Commission in relation to Article 10 of Regulation 141/2000 on orphan medicinal products - Annex 3","type":"report","status":"unknown","consultation_date":"","first_published_date":"2005-07-25T02:00:00Z","last_updated_date":"2005-07-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/comp-report-commission-relation-article-10-regulation-1412000-orphan-medicinal-products-annex-3_en.pdf"},
    {"id":"37494","name":"EU/3/08/583: Public summary of positive opinion for orphan designation of gadodiamide (liposomal) for the adjunctive treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-29T02:00:00Z","last_updated_date":"2009-06-29T02:00:00Z","reference_number":"EMEA/COMP/560580/2008draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308583-public-summary-positive-opinion-orphan-designation-gadodiamide-liposomal-adjunctive-treatment-glioma_en.pdf"},
    {"id":"37496","name":"Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 1) (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-04-25T17:00:00Z","last_updated_date":"2013-04-25T17:00:00Z","reference_number":"EMA/395730/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-addendum-i-member-states-requirements-transmission-information-non-interventional-post-authorisation-safety-studies-rev-1-superseded_en.pdf"},
    {"id":"37500","name":"EU/3/10/840: Public summary of opinion on orphan designation: Recombinant human histone H1.3 and recombinant human N-bis-met-histone H1.3 for the treatment of acute lymphoblastic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-07T01:00:00Z","last_updated_date":"2013-03-13T01:00:00Z","reference_number":"EMA/COMP/740425/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310840-public-summary-opinion-orphan-designation-recombinant-human-histone-h13-and-recombinant-human-n-bis-met-histone-h13-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"37501","name":"Presentation - Latest development: European Union cooperation on Health Technology Assessment (HTA) (Flora Giorgio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-11-24T18:30:00Z","last_updated_date":"2014-11-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-latest-development-european-union-cooperation-health-technology-assessment-hta-flora-giorgio_en.pdf"},
    {"id":"37502","name":"Questions and answers on the withdrawal of the application for change to the marketing authorisation for  Nutropinaq","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-02-21T01:00:00Z","last_updated_date":"2008-02-21T01:00:00Z","reference_number":"EMEA/166909/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-nutropinaq_sv.pdf"}},
    {"id":"37503","name":"EU/3/16/1641: Public summary of opinion on orphan designation: Antisense oligonucleotide complementary to the exonic splicer enhancer sequence at intron 26 of the centrosomal protein 290 pre-mRNA for the treatment of Leb...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-31T02:00:00Z","last_updated_date":"2016-05-31T02:00:00Z","reference_number":"EMA/COMP/248706/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161641-public-summary-opinion-orphan-designation-antisense-oligonucleotide-complementary-exonic-splicer-enhancer-sequence-intron-26-centrosomal-protein-290-pre-mrna-treatment-leb_en.pdf"},
    {"id":"37504","name":"Overview of comments received on 'Draft Guideline on manufacture of the finished dosage form' (EMA/CHMP/QWP/245074) - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-11-17T18:30:00Z","last_updated_date":"2017-11-17T18:30:00Z","reference_number":"EMA/CHMP/QWP/104223/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-draft-guideline-manufacture-finished-dosage-form-emachmpqwp245074-revision-1_en.pdf"},
    {"id":"37505","name":"EU/3/10/793: Public summary of opinion on orphan designation: N-(6-(2-aminophenylamino)-6-oxohexyl)-4-methylbenzamide for the treatment of Friedreich’s ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-14T02:00:00Z","last_updated_date":"2010-10-14T02:00:00Z","reference_number":"EMA/COMP/455242/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310793-public-summary-opinion-orphan-designation-n-6-2-aminophenylamino-6-oxohexyl-4-methylbenzamide-treatment-friedreichs-ataxia_en.pdf"},
    {"id":"37506","name":"Questions and answers on the outcome of extension of indication application for Kogenate Bayer and Helixate Nexgen (octocog alfa)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-03-22T17:12:00Z","last_updated_date":"2012-03-22T17:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-extension-indication-application-kogenate-bayer-and-helixate-nexgen-octocog-alfa_en.pdf"},
    {"id":"37507","name":"Letter from Japan to the European Union","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-02-02T01:00:00Z","last_updated_date":"2007-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-japan-european-union_en.pdf"},
    {"id":"37509","name":"Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-04-29T14:25:00Z","last_updated_date":"2016-04-29T14:25:00Z","reference_number":"EMA/CHMP/BWP/187338/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-process-validation-manufacture-biotechnology-derived-active-substances-and-data-be-provided-regulatory-submission_en.pdf"},
    {"id":"37511","name":"EU/3/17/1932: Public summary of opinion on orphan designation : Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin for the treatment of Prader-Willi syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T11:37:00Z","last_updated_date":"2018-01-08T11:37:00Z","reference_number":"EMA/COMP/632552/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171932-public-summary-opinion-orphan-designation-synthetic-cyclic-8-amino-acid-analogue-human-unacylated-ghrelin-treatment-prader-willi-syndrome_en.pdf"},
    {"id":"37512","name":"Guidance on format of the risk-management plan in the European Union part II: Module SIV - Populations not studied in clinical trials","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2013-08-21T02:00:00Z","reference_number":"EMA/465927/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-ii-module-siv-populations-not-studied-clinical-trials_en.doc"},
    {"id":"37514","name":"Prednisolone (Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-07-25T12:00:00Z","last_updated_date":"2013-07-25T12:00:00Z","reference_number":"EMA/CVMP/78357/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/prednisolone-equidae-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"37518","name":"Change to list of species and breeds for 2009","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-10-16T02:00:00Z","last_updated_date":"2009-10-16T02:00:00Z","reference_number":"EMEA/CVMP/PhVWP/283195/2009","document_url":"https://www.ema.europa.eu/en/documents/other/change-list-species-and-breeds-2009_en.xls"},
    {"id":"37519","name":"Presentation - European-public-assessment-report summary template (Daniel Glanville)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-public-assessment-report-summary-template-daniel-glanville_en.pdf"},
    {"id":"37521","name":"Guidelines and concept papers adopted during the CHMP meeting 21-24 September 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-09-30T17:10:00Z","last_updated_date":"2015-09-30T17:10:00Z","reference_number":"EMA/38594/2015 Corr.","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-21-24-september-2015_en.pdf"},
    {"id":"37524","name":"CVMP summary of positive opinion for Proteq West Nile","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-06-10T02:00:00Z","last_updated_date":"2011-06-10T02:00:00Z","reference_number":"EMA/CVMP/396064/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-proteq-west-nile_en.pdf"},
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    {"id":"37535","name":"COMP meeting report on the review of applications for orphan designation: June 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-06-29T13:36:00Z","last_updated_date":"2017-06-29T13:36:00Z","reference_number":"EMA/COMP/336592/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-june-2017_en.pdf"},
    {"id":"37537","name":"European Medicines Agency recommends suspension of marketing authorisations for carisoprodol-containing medicinal products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-11-16T00:09:21Z","last_updated_date":"2007-11-16T00:09:21Z","reference_number":"EMEA/520463/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-suspension-marketing-authorisations-carisoprodol-containing-medicinal-products_en.pdf"},
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    {"id":"37545","name":"European Medicines Agency recommends restricting use of estradiol-containing creams Linoladiol N and Linoladiol HN","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-12-20T15:00:00Z","last_updated_date":"2013-12-20T15:00:00Z","reference_number":"EMA/796289/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-estradiol-containing-creams-linoladiol-n-and-linoladiol-hn_en.pdf"},
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    {"id":"37549","name":"EMEA Paediatric Working Party meets for last time ahead of creation of new\n\nPaediatric Committee","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-11T02:00:00Z","last_updated_date":"2007-06-11T02:00:00Z","reference_number":"EMEA/259192/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-paediatric-working-party-meets-last-time-ahead-creation-new-paediatric-committee_en.pdf"},
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    {"id":"37553","name":"Questions and answers on Article 33(4) veterinary referral procedures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T18:00:00Z","last_updated_date":"2017-12-20T18:00:00Z","reference_number":"EMA/503275/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-article-334-veterinary-referral-procedures_en.pdf"},
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    {"id":"37559","name":"Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"37560","name":"Introduction to EU Regulatory system and GMP Inspection system. The Qualified Person - David Cockburn","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-20T02:09:21Z","last_updated_date":"2009-10-20T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-eu-regulatory-system-and-gmp-inspection-system-qualified-person-david-cockburn_en.pdf"},
    {"id":"37564","name":"Final list of references supporting the assessment of Ononis spinosa L., radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-05-28T02:00:00Z","last_updated_date":"2014-05-28T02:00:00Z","reference_number":"EMA/HMPC/138319/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-ononis-spinosa-l-radix_en.pdf"},
    {"id":"37565","name":"EMA Management Board: highlights of December 2017 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-12-15T11:30:00Z","last_updated_date":"2017-12-15T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-december-2017-meeting_en.pdf"},
    {"id":"37567","name":"Presentation - EMA extrapolation framework (Christoph Male)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-31T18:00:00Z","last_updated_date":"2016-05-31T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-extrapolation-framework-christoph-male_en.pdf"},
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    {"id":"37570","name":"Appendix 1 - Pharmacovigilance inspection report template (Vet)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-02-02T16:55:00Z","last_updated_date":"2016-04-04T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-1-pharmacovigilance-inspection-report-template-vet_en.doc"},
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    {"id":"37574","name":"Iodocasein/thiamine-containing medicinal products-Article 107 referral-Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/iodocaseinthiamine-containing-medicinal-products-article-107-referral-annex-ii_sv.pdf"}},
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    {"id":"37583","name":"EU/3/02/122: Public summary of positive opinion for orphan designation of etilefrine for the treatment of low flow priapism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2002-12-13T01:00:00Z","last_updated_date":"2013-06-25T02:00:00Z","reference_number":"EMA/COMP/27070/2002 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302122-public-summary-positive-opinion-orphan-designation-etilefrine-treatment-low-flow-priapism_en.pdf"},
    {"id":"37584","name":"Technetium (99mTc) pertechnetate: List of nationally authorised medicinal products - PSUSA/00002866/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-30T09:50:00Z","last_updated_date":"2017-10-30T09:55:13Z","reference_number":"EMA/691325/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/technetium-99mtc-pertechnetate-list-nationally-authorised-medicinal-products-psusa00002866201703_en.pdf"},
    {"id":"37585","name":"CHMP summary of positive opinion for Aubagio","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T13:00:00Z","last_updated_date":"2013-03-22T13:00:00Z","reference_number":"EMA/167896/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aubagio_en.pdf-0"},
    {"id":"37586","name":"Flyer and registration form for the annual European Medicines Agency review of the year and outlook for 2011 and beyond","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2010-10-26T02:00:00Z","last_updated_date":"2010-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/flyer-and-registration-form-annual-european-medicines-agency-review-year-and-outlook-2011-and-beyond_en.pdf"},
    {"id":"37590","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: January 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-02-27T14:50:00Z","last_updated_date":"2018-02-27T14:50:00Z","reference_number":"EMA/51903/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-january-2018_en.pdf"},
    {"id":"37593","name":"Paracetamol Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/PRAC/451078/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"37594","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T15:35:00Z","last_updated_date":"2015-02-17T15:35:00Z","reference_number":"EMA/COMP/693753/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-scenesse-afamelanotide-treatment-erythropoietic-protoporphyria_en.pdf"},
    {"id":"37595","name":"Presentation - Indications and labelling (K. Dunder, CHMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-indications-and-labelling-k-dunder-chmp_en.pdf"},
    {"id":"37596","name":"Overview of comments received on 'community herbal monograph on Verbascum thapsus L., V. densiflorum Bertol., and V. phlomoides L., flos' (EMEA/HMPC/395213/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-07-03T02:00:00Z","last_updated_date":"2008-07-03T02:00:00Z","reference_number":"EMEA/HMPC/87230/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-verbascum-thapsus-l-v-densiflorum-bertol-and-v-phlomoides-l-flos-emeahmpc3952132007_en.pdf"},
    {"id":"37599","name":"Opinion of the CVMP on the establishment of maximum residue limits: Methylprednisolone","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-03-10T16:00:00Z","last_updated_date":"2015-03-10T16:00:00Z","reference_number":"EMA/CVMP/339063/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-methylprednisolone_en.pdf-1"},
    {"id":"37601","name":"EU/3/17/1837: Public summary of opinion on orphan designation: Humanised IgG4 monoclonal antibody to the human toll-like receptor type 2 for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/80317/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171837-public-summary-opinion-orphan-designation-humanised-igg4-monoclonal-antibody-human-toll-receptor-type-2-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"37604","name":"Living, genetically modified Lactobacillus reuteri bacteria, with a plasmid containing the gene for human CXCL12-1a with an inducible promoter; and an activating peptide","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T16:33:00Z","last_updated_date":"2016-11-15T16:33:00Z","reference_number":"EMA/692834/2016","document_url":"https://www.ema.europa.eu/en/documents/report/living-genetically-modified-lactobacillus-reuteri-bacteria-plasmid-containing-gene-human-cxcl12-1a-inducible-promoter-and-activating-peptide_en.pdf"},
    {"id":"37605","name":"Presentation - Overview of regulator's experience: Adaptive designs seen in scientific advice and by the Committee for Medicinal Products for Human Use","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-regulators-experience-adaptive-designs-seen-scientific-advice-and-committee-medicinal-products-human-use_en.pdf"},
    {"id":"37610","name":"Speakers’ abstracts for their presentations - PCWP and HCPWP joint meeting - Workshop on social media","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"EMA/583182/2016","document_url":"https://www.ema.europa.eu/en/documents/other/speakers-abstracts-their-presentations-pcwp-and-hcpwp-joint-meeting-workshop-social-media_en.pdf"},
    {"id":"37611","name":"How to better apply the paediatric legislation to boost development of medicines for children - Report on a multi-stakeholder workshop held at EMA\n\non Tuesday 20 March 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-05-30T15:00:00Z","last_updated_date":"2018-05-30T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/how-better-apply-paediatric-legislation-boost-development-medicines-children-report-multi-stakeholder-workshop-held-ema-tuesday-20-march-2018_en.pdf"},
    {"id":"37613","name":"Presentation - Guidance on post-authorisation efficacy studies (Jane Moseley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-12T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-post-authorisation-efficacy-studies-jane-moseley_en.pdf"},
    {"id":"37614","name":"PDCO meeting report 18-20 May 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/PDCO/372487/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-18-20-may-2011_en.pdf"},
    {"id":"37616","name":"EU/3/15/1440: Public summary of opinion on orphan designation: Allogeneic CD4+ and CD8+ T lymphocytes ex vivo incubated with synthetic peptides of the viral antigens of cytomegalovirus, adenovirus and Epstein-Barr virus ...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/COMP/55791/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151440-public-summary-opinion-orphan-designation-allogeneic-cd4-and-cd8-t-lymphocytes-ex-vivo-incubated-synthetic-peptides-viral-antigens-cytomegalovirus-adenovirus-and-epstein-barr-virus_en.pdf"},
    {"id":"37617","name":"Submission deadlines for 2008-2009 for PIP applications and applications for waivers and answers to the request for modification plan of the application","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-08-15T02:00:00Z","last_updated_date":"2008-08-15T02:00:00Z","reference_number":"EMEA/PDCO/437852/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/submission-deadlines-2008-2009-pip-applications-and-applications-waivers-and-answers-request-modification-plan-application_en.pdf"},
    {"id":"37618","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T12:15:00Z","last_updated_date":"2018-02-07T12:15:00Z","reference_number":"EMA/CAT/65887/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-january-2018_en.pdf"},
    {"id":"37619","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid, Spain)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T15:00:00Z","last_updated_date":"2015-01-29T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-madrid-spain_en.pdf"},
    {"id":"37620","name":"Assessment Report for Authorised modified-release oral medicinal products of the WHO level III scale for the management of pain (intense sustained pain resistant to previous medications) (containing morphine, oxycodone, ...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"EMA/355008/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-authorised-modified-release-oral-medicinal-products-who-level-iii-scale-management-pain-intense-sustained-pain-resistant-previous-medications-containing-morphine-oxycodone_en.pdf"},
    {"id":"37623","name":"Marbofloxacin: Summary report  (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-03-01T01:00:00Z","last_updated_date":"1996-03-01T01:00:00Z","reference_number":"EMEA/MRL/079/96-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/marbofloxacin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"37684","name":"Questions and answers on the positive opinion on the marketing authorisation for Bronchitol (mannitol)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2011-10-21T13:59:25Z","last_updated_date":"2011-10-21T13:59:25Z","reference_number":"EMA/CHMP/834308/2011","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-positive-opinion-marketing-authorisation-bronchitol-mannitol_en.pdf"},
    {"id":"37685","name":"Committee for medicinal products for veterinary use summary of opinion: Zulvac 8 Bovis: International Non-proprietary Names (INN): inactivated Bluetongue Virus (BTV) Serotype 8","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-11-13T01:09:00Z","last_updated_date":"2009-11-13T01:09:00Z","reference_number":"EMEA/CVMP/665815/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-zulvac-8-bovis-international-non-proprietary-names-inn-inactivated-bluetongue-virus-btv-serotype-8_en.pdf"},
    {"id":"37686","name":"Ergot derivatives Article-31 referral - Dihydroergotoxine - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-dihydroergotoxine-annex-iii_sv.pdf"}},
    {"id":"37687","name":"EU/3/17/1875: Public summary of opinion on orphan designation: Recombinant human interleukin-7 fused to a hybrid crystallisable fragment region of a human antibody for treatment of idiopathic CD4 lymphocytopenia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-29T02:00:00Z","last_updated_date":"2017-06-29T02:00:00Z","reference_number":"EMA/276567/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171875-public-summary-opinion-orphan-designation-recombinant-human-interleukin-7-fused-hybrid-crystallisable-fragment-region-human-antibody-treatment-idiopathic-cd4-lymphocytopenia_en.pdf"},
    {"id":"37688","name":"Presentation - Monitoring processes and data monitoring committee composition","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-12-14T00:09:21Z","last_updated_date":"2007-12-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-processes-and-data-monitoring-committee-composition_en.pdf"},
    {"id":"37690","name":"CVMP summary of positive opinion for Activyl Tick Plus","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-11-11T01:00:00Z","last_updated_date":"2022-10-04T09:38:00Z","reference_number":"EMA/CVMP/825805/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-activyl-tick-plus_en.pdf"},
    {"id":"37692","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 05-07 November 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-08T18:00:00Z","last_updated_date":"2013-11-08T18:00:00Z","reference_number":"EMA/CVMP/651793/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-05-07-november-2013_en.pdf"},
    {"id":"37693","name":"Presentation - Indications and labelling (M. van der Graaff, Zorginstituut Nederland)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-indications-and-labelling-m-van-der-graaff-zorginstituut-nederland_en.pdf"},
    {"id":"37694","name":"2-pyrrolidone: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-07-01T02:00:00Z","last_updated_date":"1998-07-01T02:00:00Z","reference_number":"EMEA/MRL/457/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/2-pyrrolidone-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37696","name":"European Medicines Agency widens public access to documents","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-11-30T01:00:00Z","last_updated_date":"2010-11-30T01:00:00Z","reference_number":"EMA/718259/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-widens-public-access-documents_en.pdf"},
    {"id":"37697","name":"Expression of interest for software development companies: Creating electronic drug information for prescribing in the European Union","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-27T19:10:40Z","last_updated_date":"2011-07-27T19:10:40Z","reference_number":"EMA/425283/2011","document_url":"https://www.ema.europa.eu/en/documents/other/expression-interest-software-development-companies-creating-electronic-drug-information-prescribing-european-union_en.pdf"},
    {"id":"37699","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous bone marrow-derived human mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T16:40:00Z","last_updated_date":"2018-06-27T16:40:00Z","reference_number":"EMA/276929/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-bone-marrow-derived-human-mesenchymal-stem-cells_en.pdf"},
    {"id":"37700","name":"EU/3/08/557: Public summary of positive opinion for orphan designation of sapacitabine for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-05-15T02:00:00Z","last_updated_date":"2009-05-15T02:00:00Z","reference_number":"EMEA/COMP/369045/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308557-public-summary-positive-opinion-orphan-designation-sapacitabine-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"37701","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2009","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2009_en.pdf"},
    {"id":"37703","name":"Report - The workshop on paediatric investigation plans in type-2 diabetes mellitus","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-paediatric-investigation-plans-type-2-diabetes-mellitus_en.pdf"},
    {"id":"37705","name":"Hydroxyethyl starch Article-107i referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/hydroxyethyl-starch-article-107i-referral-annex-iii_no.pdf"}},
    {"id":"37706","name":"Cyfluthrin (Extrapolation to caprine species): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2009-06-30T02:00:00Z","last_updated_date":"2009-06-30T02:00:00Z","reference_number":"EMEA/CVMP/606552/2007","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cyfluthrin-extrapolation-caprine-species-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37707","name":"CVMP summary of positive opinion for  Melosus","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2010-12-10T01:00:00Z","reference_number":"EMA/CVMP/144729/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-melosus_en.pdf"},
    {"id":"37708","name":"Presentation - Strengthening the planning and implementation of risk minimisation (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-planning-and-implementation-risk-minimisation-peter-arlett_en.pdf"},
    {"id":"37710","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 2013","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-05-17T17:00:00Z","last_updated_date":"2013-05-17T17:00:00Z","reference_number":"EMA/CVMP/276523/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-14-16-may-2013_en.pdf"},
    {"id":"37711","name":"Ad hoc working party on Herbal Medicinal Products: Final comments for revision of good manufacturing practice (GMP) provisions","type":"other","status":"unknown","consultation_date":"","first_published_date":"1998-09-17T02:00:00Z","last_updated_date":"1998-09-17T02:00:00Z","reference_number":"EMEA/HMPWG/7/99","document_url":"https://www.ema.europa.eu/en/documents/other/ad-hoc-working-party-herbal-medicinal-products-final-comments-revision-good-manufacturing-practice-gmp-provisions_en.pdf"},
    {"id":"37714","name":"Draft list of references supporting the assessment of Juglans regia L., folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-01-25T01:00:00Z","last_updated_date":"2013-01-25T01:00:00Z","reference_number":"EMA/HMPC/346742/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-juglans-regia-l-folium_en.pdf"},
    {"id":"37715","name":"Galantamine: List of nationally authorised medicinal products - PSUSA/00001512/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-11-08T16:00:00Z","last_updated_date":"2016-11-08T16:00:00Z","reference_number":"EMA/735162/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/galantamine-list-nationally-authorised-medicinal-products-psusa00001512201603_en.pdf"},
    {"id":"37716","name":"Presentation - World Organisation for Animal Health (OIE) initiative to collect quantitative data on the use of antimicrobial agents in animals to establish a global database (Franà§ois Diaz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-world-organisation-animal-health-oie-initiative-collect-quantitative-data-use-antimicrobial-agents-animals-establish-global-database-franassois-diaz_en.pdf"},
    {"id":"37717","name":"Emtricitabine/rilpivirine/tenofovir disoproxil film-coated tablets 200 mg/25 mg/245 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"EMA/CHMP/805532/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/emtricitabinerilpivirinetenofovir-disoproxil-film-coated-tablets-200-mg25-mg245-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"37718","name":"Public Statement on the risks associated with the use of herbal products containing Aristolochia species","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-23T01:00:00Z","last_updated_date":"2005-11-23T01:00:00Z","reference_number":"EMEA/HMPC/138381/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-risks-associated-use-herbal-products-containing-aristolochia-species_en.pdf"},
    {"id":"37719","name":"Draft concept paper on the impact of lung and heart immaturity when\n\ninvestigating medicinal products intended for neonatal use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-11-18T01:00:00Z","last_updated_date":"2005-11-18T01:00:00Z","reference_number":"EMEA/CHMP/114218/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-impact-lung-and-heart-immaturity-when-investigating-medicinal-products-intended-neonatal-use_en.pdf"},
    {"id":"37723","name":"Presentation - Update on change management activities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-02T02:00:00Z","last_updated_date":"2017-05-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-change-management-activities_en.pdf"},
    {"id":"37724","name":"Questions and answers on the review of Regranex (becaplermin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-02-18T01:00:00Z","last_updated_date":"2010-02-18T01:00:00Z","reference_number":"EMA/312452/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-review-regranex-becaplermin_en.pdf"},
    {"id":"37725","name":"EU/3/07/452: Public summary of positive opinion for orphan designation of R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea for the treatment of gastric carcino...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/COMP/165106/2007","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307452-public-summary-positive-opinion-orphan-designation-r-1-23-dihydro-2-oxo-1-pivaloylmethyl-5-2-pyridyl-1-h-14-benzodiazepin-3-yl-3-3-methylaminophenylurea-treatment-gastric-carcino_en.pdf"},
    {"id":"37729","name":"Zinbryta Article-20 procedure - EMA review of Zinbryta confirms medicine’s risks outweigh its benefits","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-05-18T14:00:00Z","last_updated_date":"2018-07-11T14:00:00Z","reference_number":"EMA/286850/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zinbryta-article-20-procedure-ema-review-zinbryta-confirms-medicines-risks-outweigh-its-benefits_sv.pdf"}},
    {"id":"37731","name":"Clazuril: Summary report  - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-04-01T02:00:00Z","last_updated_date":"1998-04-01T02:00:00Z","reference_number":"EMEA/MRL/371/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/clazuril-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37734","name":"Hydroxyethyl-starch solutions (HES) no longer to be used in patients with sepsis or burn injuries or in critically ill patients","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-03-06T13:00:00Z","last_updated_date":"2014-03-06T13:00:00Z","reference_number":"EMA/809470/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyethyl-starch-solutions-hes-no-longer-be-used-patients-sepsis-or-burn-injuries-or-critically-ill-patients_sv.pdf"}},
    {"id":"37736","name":"Report on budgetary and financial management: Financial year 2009","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/381367/2010","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2009_en.pdf"},
    {"id":"37737","name":"Guideline on the quality aspects of single-dose veterinary spot-on products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-02-11T01:00:00Z","last_updated_date":"2009-02-11T01:00:00Z","reference_number":"EMEA/CVMP/QWP/ 544461/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-aspects-single-dose-veterinary-spot-products_en.pdf"},
    {"id":"37738","name":"European Medicines Agency 2013 priorities for drug safety research: Long-term adverse skeletal effects of bisphosphonates","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-22T18:13:28Z","last_updated_date":"2012-05-22T18:13:28Z","reference_number":"EMA/281412/2012","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-2013-priorities-drug-safety-research-long-term-adverse-skeletal-effects-bisphosphonates_en.pdf"},
    {"id":"37739","name":"Draft assessment report on Uncaria tomentosa (Willd. ex Schult.) DC., cortex","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-04-15T11:00:00Z","last_updated_date":"2015-04-15T11:00:00Z","reference_number":"EMA/HMPC/259598/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-uncaria-tomentosa-willd-ex-schult-dc-cortex_en.pdf"},
    {"id":"37742","name":"Outcome of written procedures during the period from 26 February 2010 to 2 June 2010","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2010-06-18T02:00:00Z","reference_number":"EMA/MB/281850/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-written-procedures-during-period-26-february-2010-2-june-2010_en.pdf"},
    {"id":"37744","name":"Presentation - Case study title: Improvement of clinical benefit for a sub-sub-group of paediatric systemic juvenile idiopathic arthritis patients utilising model-based dose adjustment optimisation (Roche #4) - Break-out...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-title-improvement-clinical-benefit-sub-sub-group-paediatric-systemic-juvenile-idiopathic-arthritis-patients-utilising-model-based-dose-adjustment-optimisation-roche-4-break-out_en.pdf"},
    {"id":"37746","name":"Overview of comments received on 'Answers to the request for scientific advice on the impact on public health and animal health of the use of antibiotics in animals'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-08-01T14:00:00Z","last_updated_date":"2014-12-19T15:00:00Z","reference_number":"EMA/598105/2014","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-answers-request-scientific-advice-impact-public-health-and-animal-health-use-antibiotics-animals_en.pdf"},
    {"id":"37751","name":"Polyoxyethylene sorbitan monooleate and trioleate - Summary report of the CVMP on the establishment of maximum residue limits","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-03-29T02:00:00Z","last_updated_date":"2012-03-29T02:00:00Z","reference_number":"EMEA/CVMP/72503/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/polyoxyethylene-sorbitan-monooleate-and-trioleate-summary-report-cvmp-establishment-maximum-residue-limits_en.pdf"},
    {"id":"37752","name":"CHMP summary of positive opinion for Moventig","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"EMA/CHMP/496850/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-moventig_en.pdf"},
    {"id":"37754","name":"Oxolinic acid: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-07-01T02:00:00Z","last_updated_date":"2000-07-01T02:00:00Z","reference_number":"EMEA/MRL/753/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxolinic-acid-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37757","name":"Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-09-21T16:45:01Z","last_updated_date":"2012-09-21T16:45:01Z","reference_number":"EMEA/H/A-31/001340","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-medicines-which-studies-have-been-conducted-texas-based-cetero-research-facility_en.pdf-0"},
    {"id":"37758","name":"Start of Community reviews - CHMP meeting of 27-30 May 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-30T12:00:02Z","last_updated_date":"2013-05-30T12:00:02Z","reference_number":"EMA/219461/2013","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-27-30-may-2013_en.pdf"},
    {"id":"37759","name":"Agenda - PRAC draft agenda of meeting 8-11 January 2018","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-01-08T18:10:00Z","last_updated_date":"2018-01-08T18:10:00Z","reference_number":"EMA/PRAC/9221/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-january-2018_en.pdf"},
    {"id":"37761","name":"Withdrawal assessment report for Zavesca","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/254026/2008","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zavesca_en.pdf"},
    {"id":"37762","name":"Final European Union herbal monograph on Valeriana officinalis L., aetheroleum","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:00:00Z","last_updated_date":"2016-06-20T12:00:00Z","reference_number":"EMA/HMPC/278053/2015 corr.","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-valeriana-officinalis-l-aetheroleum_en.pdf"},
    {"id":"37765","name":"Information for the package leaflet regarding phosphates used as excipients in eye drops","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/632775/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/information-package-leaflet-regarding-phosphates-used-excipients-eye-drops_en.pdf"},
    {"id":"37770","name":"EU/3/13/1121: Public summary of opinion on orphan designation: Lenvatinib for the treatment of papillary thyroid cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-05-14T12:00:00Z","last_updated_date":"2013-10-22T12:00:00Z","reference_number":"EMA/COMP/193646/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131121-public-summary-opinion-orphan-designation-lenvatinib-treatment-papillary-thyroid-cancer_en.pdf"},
    {"id":"37771","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human autologous stromal vascular fraction (SVF)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/462636/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-autologous-stromal-vascular-fraction-svf_en.pdf"},
    {"id":"37772","name":"Working party on Herbal Medicinal Products: Final proposal for a core data for  Calendulae flower","type":"other","status":"unknown","consultation_date":"","first_published_date":"2003-03-27T01:00:00Z","last_updated_date":"2003-03-27T01:00:00Z","reference_number":"EMEA/HMPWP/17/00","document_url":"https://www.ema.europa.eu/en/documents/other/working-party-herbal-medicinal-products-final-proposal-core-data-calendulae-flower_en.pdf"},
    {"id":"37778","name":"Press Release on the cardiovascular safety of non-selective NSAIDs","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-08-02T02:00:00Z","last_updated_date":"2005-08-02T02:00:00Z","reference_number":"EMEA/247323/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-cardiovascular-safety-non-selective-nsaids_en.pdf"},
    {"id":"37780","name":"Presentation - Risk management plan guidance and templates: feedback from the public consultation (Emil Cochino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T16:15:00Z","last_updated_date":"2016-08-15T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-management-plan-guidance-and-templates-feedback-public-consultation-emil-cochino_en.pdf"},
    {"id":"37781","name":"Standard operating procedure on Article 30 referrals triggered by the European Commission or a Member State","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-06T11:40:00Z","last_updated_date":"2012-09-06T11:40:00Z","reference_number":"SOP/H/3215","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-article-30-referrals-triggered-european-commission-or-member-state_en.pdf"},
    {"id":"37783","name":"Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-15T13:30:00Z","last_updated_date":"2017-06-15T13:30:00Z","reference_number":"EMA/376407/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/dinoprostone-list-nationally-authorised-medicinal-products-psusa00001104201609_en.pdf"},
    {"id":"37788","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 9-11 October 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-10-18T12:00:00Z","last_updated_date":"2013-10-18T12:00:00Z","reference_number":"EMA/PDCO/618657/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-9-11-october-2013_en.pdf"},
    {"id":"37791","name":"EU Support for Stem Cell Research, Dr Charles Kessler, EC DG Research","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-support-stem-cell-research-dr-charles-kessler-ec-dg-research_en.pdf"},
    {"id":"37792","name":"Communication on medicines — now and tomorrow","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"EMA/194543/2016","document_url":"https://www.ema.europa.eu/en/documents/other/communication-medicines-now-and-tomorrow_en.pdf"},
    {"id":"37794","name":"Guideline on the use of near-infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-06-05T16:00:00Z","last_updated_date":"2014-06-05T16:00:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/17760/2009 Rev2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-near-infrared-spectroscopy-pharmaceutical-industry-and-data-requirements-new-submissions-and-variations_en.pdf"},
    {"id":"37795","name":"Presentation - National competent authorities experience with environmental risk assessment (ERA) before setting clinic trials: Procedure and experience in Germany (Brigitte Anliker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-national-competent-authorities-experience-environmental-risk-assessment-era-setting-clinic-trials-procedure-and-experience-germany-brigitte-anliker_en.pdf"},
    {"id":"37796","name":"ICH: S 4: Duration of chronic toxicity testing in animals (rodent and non rodent toxicity testing) - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-11-30T01:00:00Z","last_updated_date":"1998-11-30T01:00:00Z","reference_number":"CPMP/ICH/300/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-4-duration-chronic-toxicity-testing-animals-rodent-and-non-rodent-toxicity-testing-step-5_en.pdf"},
    {"id":"37798","name":"Overview of comments on EMA/641479/2014 Draft proposal for an addendum, on transparency, to the 'Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-12-03T13:30:00Z","last_updated_date":"2015-12-03T13:30:00Z","reference_number":"EMA/739149/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-ema6414792014-draft-proposal-addendum-transparency-functional-specifications-eu-portal-and-eu-database-be-audited-ema421762014_en.pdf"},
    {"id":"37799","name":"Agenda - European Medicines Agency-European Federation of Pharmaceutical Industries and Associations modelling and simulation workshop - Break-out session 1","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T17:00:00Z","last_updated_date":"2012-04-30T14:00:00Z","reference_number":"EMA/926026/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-european-federation-pharmaceutical-industries-and-associations-modelling-and-simulation-workshop-break-out-session-1_en.pdf"},
    {"id":"37800","name":"Presentation - Topic 2 - Efficacy endpoints in clinical trials (Lawrence Geiter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-2-efficacy-endpoints-clinical-trials-lawrence-geiter_en.pdf"},
    {"id":"37803","name":"Committee for veterinary medicinal products: Meeting of 11 to 13 February 2003","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-02-14T12:39:21Z","last_updated_date":"2003-02-14T12:39:21Z","reference_number":"EMEA/CVMP/195/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-meeting-11-13-february-2003_en.pdf"},
    {"id":"37804","name":"Agenda - PRAC draft agenda of meeting 8-11 June 2015","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-06-09T19:35:00Z","last_updated_date":"2015-06-09T19:35:00Z","reference_number":"EMA/PRAC/386470/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-june-2015_en.pdf"},
    {"id":"37805","name":"Short-acting beta-agonists Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/short-acting-beta-agonists-article-31-referral-notification_en.pdf"},
    {"id":"37807","name":"Annex VI - List of flupirtine-containing medicinal products in the EU","type":"additional-monitoring","status":"unknown","consultation_date":"","first_published_date":"2014-02-26T15:00:00Z","last_updated_date":"2017-09-27T12:30:00Z","reference_number":"EMA/68528/2014 CORRECTION 4*","document_url":"https://www.ema.europa.eu/en/documents/additional-monitoring/annex-vi-list-flupirtine-containing-medicinal-products-eu_en.xls"},
    {"id":"37809","name":"European Medicines Agency/Committee for Proprietary Medicinal Products Working Group with Patients' Organisations -  Outcome of discussions: Recommendations and proposals for action","type":"report","status":"unknown","consultation_date":"","first_published_date":"2004-04-20T03:00:00Z","last_updated_date":"2004-04-20T03:00:00Z","reference_number":"EMEA/CPMP/5819/04","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencycommittee-proprietary-medicinal-products-working-group-patients-organisations-outcome-discussions-recommendations-and-proposals-action_en.pdf"},
    {"id":"37812","name":"EU/3/18/2035: Public summary of opinion on orphan designation: Efpegsomatropin for the treatment of growth hormone deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-08-21T12:49:00Z","last_updated_date":"2018-08-21T12:49:00Z","reference_number":"EMA/380699/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182035-public-summary-opinion-orphan-designation-efpegsomatropin-treatment-growth-hormone-deficiency_en.pdf"},
    {"id":"37817","name":"Cozaar - Article 29 Paediatrics referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-01-13T01:00:00Z","last_updated_date":"2012-01-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cozaar-article-29-paediatrics-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"37820","name":"Lasalocid sodium (Extension to eggs): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2007-05-01T02:00:00Z","last_updated_date":"2007-05-01T02:00:00Z","reference_number":"EMEA/CVMP/201708/2007-FINAL-corr","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lasalocid-sodium-extension-eggs-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37822","name":"CVMP summary of positive opinion for Sedadex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-06-17T02:00:00Z","last_updated_date":"2016-06-17T02:00:00Z","reference_number":"EMA/CVMP/371866/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-sedadex_en.pdf"},
    {"id":"37823","name":"Draft assessment report on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-07-28T02:00:00Z","last_updated_date":"2011-07-28T02:00:00Z","reference_number":"EMA/HMPC/722365/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-cola-nitida-vent-schott-et-endl-and-its-varieties-and-cola-acuminata-p-beauv-schott-et-endl-semen_en.pdf"},
    {"id":"37824","name":"Public summary of the evaluation of the proposed product-specific waiver: Ranibizumab for treatment of choroidal neovascularisation and treatment of macular oedema","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T11:30:00Z","last_updated_date":"2014-10-21T11:30:00Z","reference_number":"EMA/511515/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-ranibizumab-treatment-choroidal-neovascularisation-and-treatment-macular-oedema_en.pdf"},
    {"id":"37825","name":"Vepesid Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/vepesid-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/vepesid-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/vepesid-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/vepesid-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/vepesid-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/vepesid-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/vepesid-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/vepesid-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/vepesid-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/vepesid-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/vepesid-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/vepesid-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/vepesid-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/vepesid-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/vepesid-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/vepesid-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/vepesid-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/vepesid-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/vepesid-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/vepesid-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/vepesid-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/vepesid-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/vepesid-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"37826","name":"38th meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2003-09-12T02:00:00Z","last_updated_date":"2003-09-12T02:00:00Z","reference_number":"EMEA/COMP/1439/03","document_url":"https://www.ema.europa.eu/en/documents/press-release/38th-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"37827","name":"Committee for medicinal products for human use, summary of positive opinion for Rivastigmine Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2009-02-18T01:00:00Z","reference_number":"EMEA/CHMP/100894/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-rivastigmine-teva_en.pdf"},
    {"id":"37828","name":"Standard operating procedure for processing of parallel distribution notifications of a change","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-28T12:00:00Z","last_updated_date":"2012-09-28T12:00:00Z","reference_number":"SOP/INSP/2039","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-processing-parallel-distribution-notifications-change_en.pdf"},
    {"id":"37829","name":"Presentation - Manufacturing process changes, biologic product comparability and post approval changes (Nanna Aaby Kruse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-27T02:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-manufacturing-process-changes-biologic-product-comparability-and-post-approval-changes-nanna-aaby-kruse_en.pdf"},
    {"id":"37830","name":"EU/3/14/1290: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene for the treatment of choroideraemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2015-06-08T02:00:00Z","reference_number":"EMA/COMP/296144/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141290-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-2-containing-human-rep1-gene-treatment-choroideraemia_en.pdf"},
    {"id":"37831","name":"EU/3/17/1840: Public summary of opinion on orphan designation: N-(4-(1-cyanocyclopentyl)phenyl)-2-(4-pyridinylmethyl)amino-3-pyridinecarboxamide methanesulfonate for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/72986/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171840-public-summary-opinion-orphan-designation-n-4-1-cyanocyclopentylphenyl-2-4-pyridinylmethylamino-3-pyridinecarboxamide-methanesulfonate-treatment-gastric-cancer_en.pdf"},
    {"id":"37834","name":"Note for guidance on process validation","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-03-01T01:00:00Z","last_updated_date":"2001-03-01T01:00:00Z","reference_number":"CPMP/QWP/848/96","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-process-validation_en.pdf"},
    {"id":"37835","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-05-12T17:00:00Z","last_updated_date":"2015-05-12T17:00:00Z","reference_number":"EMA/246014/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-april-2015_en.pdf"},
    {"id":"37836","name":"Withdrawal letter: Tasigna","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-tasigna_en.pdf"},
    {"id":"37837","name":"EU/3/11/904: Public summary of opinion on orphan designation: Heterologous human adult liver-derived stem cells for the treatment of ornithine transcarbamylase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/COMP/661152/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311904-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-stem-cells-treatment-ornithine-transcarbamylase-deficiency_en.pdf"},
    {"id":"37838","name":"Lisonorm - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-12-15T00:08:21Z","last_updated_date":"2008-12-15T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lisonorm-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"37839","name":"CHMP post-authorisation summary of positive opinion for Pegasys on 23 October 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:00:00Z","last_updated_date":"2008-10-23T02:00:00Z","reference_number":"EMEA/CHMP/561136/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pegasys-23-october-2008_en.pdf"},
    {"id":"37840","name":"Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-01-03T18:21:00Z","last_updated_date":"2017-01-03T18:21:00Z","reference_number":"EMA/CVMP/QWP/128710/2004-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mumslimited-market_en.pdf"},
    {"id":"37842","name":"Overview of comments on the qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of Phase II dose finding studies under model uncertainty'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-10T10:20:00Z","last_updated_date":"2014-02-10T10:20:00Z","reference_number":"EMA/617236/2013","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-qualification-opinion-mcp-mod-efficient-statistical-methodology-model-based-design-and-analysis-phase-ii-dose-finding-studies-under-model-uncertainty_en.pdf"},
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    {"id":"37880","name":"Applying for EU marketing authorisation for medicinal products for veterinary use","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2015-05-18T18:17:00Z","last_updated_date":"2015-05-18T18:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/applying-eu-marketing-authorisation-medicinal-products-veterinary-use_en.pdf"},
    {"id":"37882","name":"Presentation - Statistical tests, Bayesian analysis, or heuristic rules for demonstration of analytical biosimilarity? (R. Burdick, Elion Labs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-statistical-tests-bayesian-analysis-or-heuristic-rules-demonstration-analytical-biosimilarity-r-burdick-elion-labs_en.pdf"},
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    {"id":"37884","name":"Continuous dialogue from product development throughout product lifecycle Andre Broekmans - Schering-Plough","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/continuous-dialogue-product-development-throughout-product-lifecycle-andre-broekmans-schering-plough_en.pdf"},
    {"id":"37885","name":"Final Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-06-02T02:00:00Z","last_updated_date":"2014-06-02T02:00:00Z","reference_number":"EMA/HMPC/342332/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba_en.pdf"},
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    {"id":"37889","name":"Monensin (Cattle, including dairy cows): Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2007-05-01T02:00:00Z","last_updated_date":"2007-05-01T02:00:00Z","reference_number":"EMEA/CVMP/185123/2007-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/monensin-cattle-including-dairy-cows-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37891","name":"Case studies - Harmonising the approach to VeDDRA coding workshop - 27 November 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-11T18:20:00Z","last_updated_date":"2014-02-11T18:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/case-studies-harmonising-approach-veddra-coding-workshop-27-november-2013_en.pdf"},
    {"id":"37892","name":"Presentation - European Network of Paediatric Research at the European Medicines Agency: update on recent activities (Irmgard Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-05-27T17:00:00Z","last_updated_date":"2016-05-27T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-paediatric-research-european-medicines-agency-update-recent-activities-irmgard-eichler_en.pdf"},
    {"id":"37895","name":"Presentation - Benefits of Public Health, Eugene Major","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-07-29T02:00:00Z","last_updated_date":"2011-07-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-benefits-public-health-eugene-major_en.pdf"},
    {"id":"37897","name":"Guideline on the declaration of the quantitative composition / potency labelling of biological medicinal products that contain modified proteins as active substance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T17:55:00Z","last_updated_date":"2014-03-21T17:55:00Z","reference_number":"EMA/CHMP/BWP/85290/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-declaration-quantitative-composition-potency-labelling-biological-medicinal-products-contain-modified-proteins-active-substance_en.pdf"},
    {"id":"37898","name":"Meeting report - Developing a proactive approach to the prevention of medicines shortages due to manufacturing and quality problems","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T10:00:00Z","last_updated_date":"2016-01-27T10:00:00Z","reference_number":"EMA/679967/2015","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-developing-proactive-approach-prevention-medicines-shortages-due-manufacturing-and-quality-problems_en.pdf"},
    {"id":"37905","name":"Captopril / hydrochlorothiazide: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - 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    {"id":"37912","name":"Glossary on herbal teas","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-04-28T02:00:00Z","last_updated_date":"2011-01-03T01:00:00Z","reference_number":"EMA/HMPC/5829/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/glossary-herbal-teas_en.pdf"},
    {"id":"37914","name":"Presentation - Developmental pharmacokinetics/pharmacodynamics: What have we learnt?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-05-13T02:09:21Z","last_updated_date":"2008-05-13T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-developmental-pharmacokineticspharmacodynamics-what-have-we-learnt_en.pdf"},
    {"id":"37915","name":"Presentation - Overview of EMA's interaction with patients' and consumers' organisations in 2013 (David Haerry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-emas-interaction-patients-and-consumers-organisations-2013-david-haerry_en.pdf"},
    {"id":"37916","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord (cartilage lesions)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-08-26T12:30:00Z","last_updated_date":"2015-08-26T12:30:00Z","reference_number":"EMA/561832/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-mesenchymal-stem-cells-derived-whartons-jelly-tissue-umbilical-cord-cartilage-lesions_en.pdf"},
    {"id":"37918","name":"Presentation - Workshop on paediatric investigation plans in type-2 diabetes mellitus - conclusions (Paolo Tomasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-paediatric-investigation-plans-type-2-diabetes-mellitus-conclusions-paolo-tomasi_en.pdf"},
    {"id":"37920","name":"Recommendation on the need for revision of (CHMP) (note for guidance on the investigation of bioavailability and bioequivalence)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-05-24T02:00:00Z","last_updated_date":"2007-05-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/200943/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/recommendation-need-revision-chmp-note-guidance-investigation-bioavailability-and-bioequivalence_en.pdf"},
    {"id":"37922","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2013","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2015-01-09T13:30:00Z","last_updated_date":"2015-01-09T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2013_en.pdf"},
    {"id":"37923","name":"Presentation - Communication on medication errors - What does the patient need to know? (Franà§ois Houà¿ez and Rob Camp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-01T01:00:00Z","last_updated_date":"2017-03-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-medication-errors-what-does-patient-need-know-franassois-houaez-and-rob-camp_en.pdf"},
    {"id":"37924","name":"Note for guidance on pharmaceutical development","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-01-12T01:00:00Z","last_updated_date":"2010-01-12T01:00:00Z","reference_number":"EMEA/CHMP/167068/2004 - ICH","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-pharmaceutical-development_en.pdf"},
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    {"id":"37927","name":"Registration form - Regulatory workshop on clinical trials designs in neuromyelitis optica and spectrum disorders","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-07-07T16:00:00Z","last_updated_date":"2014-07-07T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-regulatory-workshop-clinical-trials-designs-neuromyelitis-optica-and-spectrum-disorders_en.pdf"},
    {"id":"37928","name":"Gadobutrol: CMDh scientific conclusions and grounds for the variation,\n\namendments to the product information, and timetable\n\nfor the implementation - PSUSA/00001502/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-11T01:00:00Z","last_updated_date":"2016-10-19T12:37:29Z","reference_number":"EMA/PRAC/4354/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadobutrol-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001502201504_en.pdf"},
    {"id":"37932","name":"Concept paper on the need for a guideline on the clinical investigation of specific immunoglobulins","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/BPWP/161104/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-investigation-specific-immunoglobulins_en.pdf"},
    {"id":"37933","name":"Presentation - CMDh: Coordination Group for Mutual Recognition and Decentralised Procedures - Human (Anne Ambrose)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-10T18:30:00Z","last_updated_date":"2015-08-10T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cmdh-coordination-group-mutual-recognition-and-decentralised-procedures-human-anne-ambrose_en.pdf"},
    {"id":"37934","name":"Initial notices for parallel distribution – September 2014","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-10-14T14:00:00Z","last_updated_date":"2014-10-14T14:00:00Z","reference_number":"EMA/624990/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-september-2014_en.pdf"},
    {"id":"37935","name":"Public statement on IDflu: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T11:00:00Z","last_updated_date":"2018-03-28T11:00:00Z","reference_number":"EMA/809462/2017","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-idflu-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"37936","name":"Reflection paper on the demonstration of a possible impact of maternally derived antibodies on vaccine efficacy in young animals","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-03-18T01:00:00Z","last_updated_date":"2010-03-18T01:00:00Z","reference_number":"EMA/CVMP/IWP/439467/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-demonstration-possible-impact-maternally-derived-antibodies-vaccine-efficacy-young-animals_en.pdf"},
    {"id":"37937","name":"Committee for Medicinal Products for Veterinary Use (CVMP) - Monthly report of application procedures, guidelines and related documents - February 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-02-21T15:43:00Z","last_updated_date":"2012-02-21T15:43:00Z","reference_number":"EMA/112844/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-veterinary-use-cvmp-monthly-report-application-procedures-guidelines-and-related-documents-february-2012_en.pdf"},
    {"id":"37938","name":"Ailanthus altissima: Summary Report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/ 659/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ailanthus-altissima-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"37940","name":"EU/3/14/1326: Public summary of opinion on orphan designation: Vector based on an adeno-associated virus serotype 2 backbone, pseudo-serotyped with a type 8 capsid, which carries the coding sequence of the human TYMP gen...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/432877/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141326-public-summary-opinion-orphan-designation-vector-based-adeno-associated-virus-serotype-2-backbone-pseudo-serotyped-type-8-capsid-which-carries-coding-sequence-human-tymp-gen_en.pdf"},
    {"id":"37942","name":"EU/3/12/1018: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene for the treatment of glycogen storage disease type II (Pompe's disease)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-07-24T16:00:00Z","last_updated_date":"2012-07-24T16:00:00Z","reference_number":"EMA/COMP/381188/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121018-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-containing-human-acid-alfa-glucosidase-gene-treatment-glycogen-storage-disease-type-ii-pompes-disease_en.pdf"},
    {"id":"37943","name":"Questions and answers on Levact and associated names (bendamustine hydrochloride, 2.5 mg/ml, powder for concentrate for solution for infusion)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-03-20T00:59:00Z","last_updated_date":"2011-09-09T01:59:00Z","reference_number":"EMEA/H/A-29/1238","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-levact-and-associated-names-bendamustine-hydrochloride-25-mgml-powder-concentrate-solution-infusion_sv.pdf"}},
    {"id":"37944","name":"INS-GCP-4 procedure for reporting of good-clinical-practice inspections requested by the CHMP","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2017-05-15T16:19:00Z","reference_number":"EMA/INS/GCP/158549/2016 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ins-gcp-4-procedure-reporting-good-clinical-practice-inspections-requested-chmp_en.pdf"},
    {"id":"37946","name":"Presentation - Paediatric Investigation Plans for treatment of osteoporosis (Richard Veselà½)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-09T02:00:00Z","last_updated_date":"2014-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-investigation-plans-treatment-osteoporosis-richard-vesela-12_en.pdf"},
    {"id":"37947","name":"Hydrochlorothiazide / ramipril: List of nationally authorised medicinal products - PSUSA/00001660/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-10T17:00:00Z","last_updated_date":"2018-09-10T17:00:00Z","reference_number":"EMA/611352/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-ramipril-list-nationally-authorised-medicinal-products-psusa00001660201801_en.pdf"},
    {"id":"37948","name":"Novosis Goserelin - Article 36 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"EMEA/H/A-36/1295","document_url":"https://www.ema.europa.eu/en/documents/referral/novosis-goserelin-article-36-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/novosis-goserelin-article-36-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/novosis-goserelin-article-36-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/novosis-goserelin-article-36-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/novosis-goserelin-article-36-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/novosis-goserelin-article-36-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/novosis-goserelin-article-36-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/novosis-goserelin-article-36-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/novosis-goserelin-article-36-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/novosis-goserelin-article-36-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/novosis-goserelin-article-36-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/novosis-goserelin-article-36-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/novosis-goserelin-article-36-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/novosis-goserelin-article-36-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/novosis-goserelin-article-36-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/novosis-goserelin-article-36-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/novosis-goserelin-article-36-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/novosis-goserelin-article-36-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/novosis-goserelin-article-36-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/novosis-goserelin-article-36-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/novosis-goserelin-article-36-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/novosis-goserelin-article-36-referral-annex-ii_sv.pdf"}},
    {"id":"37950","name":"Public statement on Protopy (tacrolimus): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-10-08T02:09:21Z","last_updated_date":"2008-10-08T02:09:21Z","reference_number":"EMEA/511485/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-protopy-tacrolimus-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"37957","name":"Presentation - Proposals on how patients can be involved in networks (trial design etc.) and in trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposals-how-patients-can-be-involved-networks-trial-design-etc-and-trials_en.pdf"},
    {"id":"37958","name":"Public summary of the evaluation of the proposed paediatric investigation plan: \n\nDupilumab for treatment of asthma","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-19T02:00:00Z","last_updated_date":"2015-10-19T02:00:00Z","reference_number":"EMA/629439/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-paediatric-investigation-plan-dupilumab-treatment-asthma_en.pdf-0"},
    {"id":"37959","name":"Methylprednisolone (Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2015-02-24T12:00:00Z","last_updated_date":"2015-02-24T12:00:00Z","reference_number":"EMA/CVMP/339062/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/methylprednisolone-equidae-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"37960","name":"Public statement on Leflunomide (Arava) - Severe and serious hepatic reactions","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2001-03-12T01:00:00Z","last_updated_date":"2001-03-12T01:00:00Z","reference_number":"EMEA/H/5611/01/en","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-leflunomide-arava-severe-and-serious-hepatic-reactions_en.pdf"},
    {"id":"37962","name":"Presentation - Working Group on young patient advisory groups update","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-18T13:40:00Z","last_updated_date":"2017-12-18T13:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-group-young-patient-advisory-groups-update_en.pdf"},
    {"id":"37964","name":"Work instructions for secretarial tasks for initial preparation and update of veterinary European public assessment reports (EPARs)","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T13:10:00Z","last_updated_date":"2016-02-10T15:55:00Z","reference_number":"WIN/V/4035","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-secretarial-tasks-initial-preparation-and-update-veterinary-european-public-assessment-reports-epars_en.pdf"},
    {"id":"37965","name":"Timetable for generics applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-12-20T01:00:00Z","last_updated_date":"2005-12-20T01:00:00Z","reference_number":"EMEA/327896/2005","document_url":"https://www.ema.europa.eu/en/documents/other/timetable-generics-applications_en.pdf"},
    {"id":"37966","name":"Presentation - Design strategies to minimise the use of placebo in MS clinical trials (Maria Pia Sormani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-design-strategies-minimise-use-placebo-ms-clinical-trials-maria-pia-sormani_en.pdf"},
    {"id":"37967","name":"EU/3/17/1871: Public summary of opinion on orphan designation: 225Ac-lintuzumab for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-06-30T02:00:00Z","last_updated_date":"2017-06-30T02:00:00Z","reference_number":"EMA/261867/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171871-public-summary-opinion-orphan-designation-225ac-lintuzumab-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"37969","name":"PDCO meeting report 12-14 October 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-10-20T16:16:00Z","last_updated_date":"2011-10-20T16:16:00Z","reference_number":"EMA/PDCO/813133/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-12-14-october-2011_en.pdf"},
    {"id":"37970","name":"Presentation - Beyond HER2 CAR T-cells: consider how far you have fallen… (Nabil Ahmed)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T11:11:00Z","last_updated_date":"2016-12-02T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-beyond-her2-car-t-cells-consider-how-far-you-have-fallen-nabil-ahmed_en.pdf"},
    {"id":"37975","name":"CHMP summary of positive opinion for Amyvid","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2012-10-19T14:30:00Z","reference_number":"EMA/CHMP/545417/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-amyvid_en.pdf"},
    {"id":"37976","name":"Enpr-EMA networks funding sources form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-11-09T16:55:00Z","last_updated_date":"2021-03-12T14:54:00Z","reference_number":"EMA/571898/2015","document_url":"https://www.ema.europa.eu/en/documents/template-form/enpr-ema-networks-funding-sources-form_en.doc"},
    {"id":"37977","name":"EU/3/01/070: Public summary of positive opinion for orphan designation of celecoxib for the treatment of familial adenomatous polyposis (FAP)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2009-06-15T02:00:00Z","reference_number":"EMEA/COMP/264/04","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301070-public-summary-positive-opinion-orphan-designation-celecoxib-treatment-familial-adenomatous-polyposis-fap_en.pdf"},
    {"id":"37978","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting 22-25 April 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-29T17:40:00Z","last_updated_date":"2014-04-29T17:40:00Z","reference_number":"EMA/124016/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-22-25-april-2014_en.pdf"},
    {"id":"37979","name":"Presentation - Holistic approach to paediatric research: young people and patient involvement (J. Preston)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T12:00:00Z","last_updated_date":"2018-06-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-holistic-approach-paediatric-research-young-people-and-patient-involvement-j-preston_en.pdf"},
    {"id":"37982","name":"Work plan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2009","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2009-03-18T01:00:00Z","last_updated_date":"2009-03-18T01:00:00Z","reference_number":"EMEA/INS/GCP/449289/2008","document_url":"https://www.ema.europa.eu/en/documents/other/work-plan-good-clinical-practice-inspectors-working-group-gcp-iwg-2009_en.pdf"},
    {"id":"37983","name":"Letter of support for measures of executive function and basic emotions to be used to stratify populations of people with autism spectrum disorder (ASD) and predict clinical outcome","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T12:00:00Z","last_updated_date":"2015-12-09T12:00:00Z","reference_number":"EMA/794534/2015","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-measures-executive-function-and-basic-emotions-be-used-stratify-populations-people-autism-spectrum-disorder-asd-and-predict-clinical-outcome_en.pdf"},
    {"id":"37985","name":"Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-03-30T17:00:00Z","last_updated_date":"2018-11-30T17:15:00Z","reference_number":"EMA/164014/2018 Rev. 2.0.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.doc"},
    {"id":"37987","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 6-8 February 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-02-15T12:50:00Z","last_updated_date":"2013-02-15T12:50:00Z","reference_number":"EMA/PDCO/92072/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-6-8-february-2013_en.pdf"},
    {"id":"37988","name":"EU/3/07/471: Public summary of positive opinion for orphan designation of human coagulation factor X for the treatment of hereditary factor X deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2008-07-29T02:00:00Z","reference_number":"EMEA/COMP/138276/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307471-public-summary-positive-opinion-orphan-designation-human-coagulation-factor-x-treatment-hereditary-factor-x-deficiency_en.pdf"},
    {"id":"37989","name":"Inductos Article-20 procedure – Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-09-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/inductos-article-20-procedure-timetable-procedure_en.pdf"},
    {"id":"37990","name":"Presentation - Oversight of clinical trials in Europe - Member State perspective (Gunnar Danielsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-oversight-clinical-trials-europe-member-state-perspective-gunnar-danielsson_en.pdf"},
    {"id":"37992","name":"Guideline on the summary of product characteristics for anthelmintics - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-07-12T02:09:00Z","last_updated_date":"2007-07-12T02:09:00Z","reference_number":"EMEA/CVMP/EWP/170208/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-summary-product-characteristics-anthelmintics-first-version_en.pdf"},
    {"id":"37993","name":"Questions and answers on the suspension of buflomedil-containing medicines","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-11-17T16:56:21Z","last_updated_date":"2012-06-13T17:56:21Z","reference_number":"EMEA/H/A-107/1293","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-suspension-buflomedil-containing-medicines_sv.pdf"}},
    {"id":"37995","name":"Committee for Advanced Therapies adopts first classification recommendation for an advanced therapy medicinal product","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-30T02:00:00Z","last_updated_date":"2009-06-30T02:00:00Z","reference_number":"EMEA/CAT/405761/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-advanced-therapies-adopts-first-classification-recommendation-advanced-therapy-medicinal-product_en.pdf"},
    {"id":"37998","name":"Introduction - Meeting of the Paediatric Diabetes Mellitus Experts Group","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-06T02:00:00Z","last_updated_date":"2010-05-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-meeting-paediatric-diabetes-mellitus-experts-group_en.pdf"},
    {"id":"38002","name":"Public summary of the evaluation of the proposed product-specific waiver: aflibercept for the treatment of branch retinal vein occlusion and for the treatment of choroidal neovascularisation secondary to pathologic myopi...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-31T17:45:00Z","last_updated_date":"2014-07-31T17:45:00Z","reference_number":"EMA/448345/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-aflibercept-treatment-branch-retinal-vein-occlusion-and-treatment-choroidal-neovascularisation-secondary-pathologic-myopi_en.pdf"},
    {"id":"38003","name":"Agenda - European Medicines Agency veterinary medicines innovation day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-02-21T11:40:00Z","last_updated_date":"2018-04-18T17:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-veterinary-medicines-innovation-day_en.pdf"},
    {"id":"38005","name":"Presentation - Population pharmacokinetics and optimal design of paediatric studies for famciclovir","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-population-pharmacokinetics-and-optimal-design-paediatric-studies-famciclovir_en.pdf"},
    {"id":"38006","name":"Human medicines highlights - April 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-05-08T16:20:00Z","last_updated_date":"2015-05-08T16:20:00Z","reference_number":"Issue 74","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-april-2015_en.pdf"},
    {"id":"38007","name":"CHMP summary of positive opinion for Eliquis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-03-18T01:00:00Z","last_updated_date":"2011-03-18T01:00:00Z","reference_number":"EMA/CHMP/87152/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eliquis_en.pdf"},
    {"id":"38008","name":"Numeta Article-107i procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-14T02:00:00Z","last_updated_date":"2013-06-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/numeta-article-107i-procedure-timetable-procedure_en.pdf"},
    {"id":"38010","name":"Open invitation to tender, EMEA/2008/62/P&B, Provision of language training for EMEA staff","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-05-03T02:00:00Z","last_updated_date":"2008-05-03T02:00:00Z","reference_number":"EMEA/206208/2008-4542","document_url":"https://www.ema.europa.eu/en/documents/other/open-invitation-tender-emea200862pb-provision-language-training-emea-staff_en.pdf"},
    {"id":"38012","name":"EU/3/04/219: Public summary of positive opinion for orphan designation of HLA-B27-derived peptide (amino acid 125-138) for the treatment of autoimmune uveitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-06-09T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"EMEA/COMP/391/2004 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304219-public-summary-positive-opinion-orphan-designation-hla-b27-derived-peptide-amino-acid-125-138-treatment-autoimmune-uveitis_en.pdf"},
    {"id":"38015","name":"Overview of comments received on Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T17:39:00Z","last_updated_date":"2017-01-03T17:39:00Z","reference_number":"EMA/CHMP/693923/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-pazopanib-film-coated-tablet-200-mg-and-400-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"38017","name":"CHMP summary of positive opinion for Rixubis","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-10-24T02:00:00Z","last_updated_date":"2014-10-24T02:00:00Z","reference_number":"EMA/CHMP/631607/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rixubis_en.pdf"},
    {"id":"38018","name":"Agenda - EMA/EFPIA info day - 23 May 2011","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-03-30T01:31:00Z","last_updated_date":"2011-05-28T01:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-emaefpia-info-day-23-may-2011_en.pdf"},
    {"id":"38019","name":"EU/3/16/1696: Public summary of opinion on orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo for the treatment of post-transplant lymphop...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-09-06T02:00:00Z","last_updated_date":"2020-05-25T02:00:00Z","reference_number":"EMA/COMP/449979/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161696-public-summary-opinion-orphan-designation-autologous-epstein-barr-virus-specific-t-cells-derived-peripheral-blood-mononuclear-cells-expanded-ex-vivo-treatment-post-transplant-lymphop_en.pdf"},
    {"id":"38023","name":"Presentation - Modelling and simulation good practices and next steps - Session 7","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-good-practices-and-next-steps-session-7_en.pdf"},
    {"id":"38025","name":"Questions and answers on the outcome of an extension of indication application for Inovelon (rufinamide)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T10:35:00Z","last_updated_date":"2017-02-08T10:35:00Z","reference_number":"EMA/848709/2016","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-extension-indication-application-inovelon-rufinamide_en.pdf"},
    {"id":"38026","name":"Alprostadil (indicated in peripheral arterial occlusive diseases): List of nationally authorised medicinal products - PSUSA/00000111/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-04T13:20:00Z","last_updated_date":"2018-06-04T13:23:00Z","reference_number":"EMA/221842/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/alprostadil-indicated-peripheral-arterial-occlusive-diseases-list-nationally-authorised-medicinal-products-psusa00000111201707_en.pdf"},
    {"id":"38027","name":"Committee for medicinal products for human use, summary of positive opinion for Sildenafil Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/CHMP/433047/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-sildenafil-teva_en.pdf"},
    {"id":"38028","name":"Committee for Orphan Medicinal Products (COMP) - Monthly report from the May 2009  meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-05-08T02:09:21Z","last_updated_date":"2009-05-08T02:09:21Z","reference_number":"EMEA/281967/2009","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-orphan-medicinal-products-comp-monthly-report-may-2009-meeting_en.pdf"},
    {"id":"38029","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (Italy)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-italy_en.pdf"},
    {"id":"38030","name":"Submission of comments on 'good pharmacovigilance practices module III – Pharmacovigilance inspections' (EMA/119871/2012)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-06-27T14:57:56Z","last_updated_date":"2012-06-27T14:57:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-good-pharmacovigilance-practices-module-iii-pharmacovigilance-inspections-ema1198712012_en.doc"},
    {"id":"38031","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 April 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T18:00:00Z","last_updated_date":"2014-04-11T18:00:00Z","reference_number":"EMA/177970/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-8-10-april-2014_en.pdf"},
    {"id":"38033","name":"Overview of comments received on 'Fingolimod capsules 0.5 mg product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T16:58:00Z","last_updated_date":"2017-01-03T16:58:00Z","reference_number":"EMA/CHMP/805860/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-fingolimod-capsules-05-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"38035","name":"Guideline on the clinical investigation of hepatitis B immunoglobulins","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T10:35:00Z","last_updated_date":"2015-07-24T10:35:00Z","reference_number":"EMA/CHMP/BPWP/585257/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-hepatitis-b-immunoglobulins_en.pdf"},
    {"id":"38036","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-10-12T02:00:00Z","last_updated_date":"2012-10-12T02:00:00Z","reference_number":"EMA/608075/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-erbitux-cetuximab_sv.pdf"}},
    {"id":"38038","name":"Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 March 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-19T01:00:00Z","last_updated_date":"2010-03-19T01:00:00Z","reference_number":"EMA/CHMP/107570/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-march-2010_en.pdf"},
    {"id":"38039","name":"EU/3/06/370: Public summary of positive opinion for orphan designation of decitabine for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2013-09-19T02:00:00Z","reference_number":"EMEA/COMP/137787/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306370-public-summary-positive-opinion-orphan-designation-decitabine-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"38042","name":"Agenda - CVMP interested parties' meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2013-06-04T02:00:00Z","last_updated_date":"2013-06-04T02:00:00Z","reference_number":"EMA/CVMP/192734/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-interested-parties-meeting_en.pdf-0"},
    {"id":"38045","name":"Enrofloxacin (Modification for bovine, porcine and poultry): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-07-01T02:00:00Z","last_updated_date":"1998-07-01T02:00:00Z","reference_number":"EMEA/MRL/388/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/enrofloxacin-modification-bovine-porcine-and-poultry-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38046","name":"Presentation - Healthy ageing and medicines: the patients' perspective of ageing","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthy-ageing-and-medicines-patients-perspective-ageing_en.pdf"},
    {"id":"38047","name":"Overview of comments received on 'Draft functional specifications for the EU portal and EU database to be audited'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-12-03T13:30:00Z","last_updated_date":"2015-12-03T13:30:00Z","reference_number":"EMA/659146/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-functional-specifications-eu-portal-and-eu-database-be-audited_en.pdf"},
    {"id":"38048","name":"Monthly Report - Pharmacovigilance Working Party (PhVWP) May 2010 plenary meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/313457/2010","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-pharmacovigilance-working-party-phvwp-may-2010-plenary-meeting_en.pdf"},
    {"id":"38053","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - June 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-06-29T14:23:00Z","last_updated_date":"2012-06-29T14:23:00Z","reference_number":"EMA/CHMP/PhVWP/427227/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-june-2012_en.pdf"},
    {"id":"38054","name":"Guideline on the clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2010-08-05T02:00:00Z","last_updated_date":"2010-08-25T02:00:00Z","reference_number":"EMEA/CHMP/EWP/431734/2008 Rev. 2 Corrigendum","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-attention-deficit-hyperactivity-disorder-adhd_en.pdf"},
    {"id":"38055","name":"Agenda - Sixth annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-06-18T19:00:00Z","reference_number":"EMA/110531/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sixth-annual-workshop-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"38057","name":"EMEA releases recommendations for better information for patients","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-04-22T02:00:00Z","last_updated_date":"2004-04-22T02:00:00Z","reference_number":"EMEA/H/10720/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-releases-recommendations-better-information-patients_en.pdf"},
    {"id":"38058","name":"Presentation - Lifecycle pharmacovigilance planning for public health: key to product development and safe and effective use of products (Peter Arlett)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/presentation-lifecycle-pharmacovigilance-planning-public-health-key-product-development-and-safe-and-effective-use-products-peter-arlett_en.pdf"},
    {"id":"38060","name":"Final overview of comments received on European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium (EMA/HMPC/750269/2016) - Revision 2","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2018-04-11T14:00:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/589805/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/final-overview-comments-received-european-union-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium-emahmpc7502692016-revision-2_en.pdf"},
    {"id":"38061","name":"Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-06-19T02:00:00Z","last_updated_date":"2010-11-10T01:00:00Z","reference_number":"EMEA/CAT/486831/2008/corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-minimum-quality-and-non-clinical-data-certification-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"38063","name":"Presentation - Statistical modelling issues arising from pharmacokinetic/pharmacodynamic bridging in paediatrics","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-statistical-modelling-issues-arising-pharmacokineticpharmacodynamic-bridging-paediatrics_en.pdf"},
    {"id":"38064","name":"Workshop report - Demonstrating significant benefit of orphan medicines: concepts, methodology and impact on access","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-07-25T18:00:00Z","last_updated_date":"2016-07-25T18:00:00Z","reference_number":"EMA/6690/2016","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-demonstrating-significant-benefit-orphan-medicines-concepts-methodology-and-impact-access_en.pdf"},
    {"id":"38065","name":"CellSeed Europe Ltd. withdraws its marketing-authorisation application for OraNera (autologous oral mucosal epithelial cells)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T16:00:00Z","last_updated_date":"2013-03-20T16:00:00Z","reference_number":"EMA/178195/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/cellseed-europe-ltd-withdraws-its-marketing-authorisation-application-oranera-autologous-oral-mucosal-epithelial-cells_en.pdf"},
    {"id":"38070","name":"Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-09T15:00:00Z","last_updated_date":"2017-07-05T13:40:00Z","reference_number":"EMA/785582/2014 rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/implementation-plan-introduction-safety-features-packaging-centrally-authorised-medicinal-products-human-use_en.pdf"},
    {"id":"38071","name":"Presentation - Medication errors and screening tool of older persons’\n\npotentially inappropriate prescriptions (STOPP) / screening tool to alert doctors to\n\nright treatment (START) criteria","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medication-errors-and-screening-tool-older-persons-potentially-inappropriate-prescriptions-stopp-screening-tool-alert-doctors-right-treatment-start-criteria_en.pdf"},
    {"id":"38072","name":"Diuretic herbal tea combinations: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2017-07-06T02:00:00Z","last_updated_date":"2017-07-06T02:00:00Z","reference_number":"EMA/236406/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/diuretic-herbal-tea-combinations-summary-public_en.pdf"},
    {"id":"38076","name":"Presentation - PDCO current approach (Chrissi Pallidis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-current-approach-chrissi-pallidis_en.pdf"},
    {"id":"38077","name":"ICH: S 7 A: Safety pharmacology studies for human pharmaceuticals - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-11-30T01:00:00Z","last_updated_date":"2000-11-30T01:00:00Z","reference_number":"CPMP/ICH/539/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-7-safety-pharmacology-studies-human-pharmaceuticals-step-5_en.pdf"},
    {"id":"38078","name":"Rimexolone:  List of nationally authorised medicinal products - PSUSA/00002647/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T18:25:00Z","last_updated_date":"2017-03-16T18:27:05Z","reference_number":"EMA/184638/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/rimexolone-list-nationally-authorised-medicinal-products-psusa00002647201510_en.pdf"},
    {"id":"38079","name":"Draft community herbal monograph on Ilex paraguariensis St. Hil., folium - First time","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/580539/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-ilex-paraguariensis-st-hil-folium-first-time_en.pdf"},
    {"id":"38081","name":"Presentation - EMA/EGA workshop - Session 3: TDDS and Appendix I + II (Jan Neuhauser)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-session-3-tdds-and-appendix-i-ii-jan-neuhauser_en.pdf"},
    {"id":"38082","name":"Agenda - Workshop on Clinical Outcome Measures and endpoints for efficacy assessment in spinal muscular atrophy","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2008-09-11T02:09:21Z","last_updated_date":"2008-09-11T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-clinical-outcome-measures-and-endpoints-efficacy-assessment-spinal-muscular-atrophy_en.pdf"},
    {"id":"38083","name":"Work plan for the CHMP Oncology Working Party for 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2018-01-10T11:00:00Z","last_updated_date":"2018-01-10T11:00:00Z","reference_number":"EMA/CHMP/413341/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-chmp-oncology-working-party-2018_en.pdf"},
    {"id":"38088","name":"Draft reflection paper on gender differences in cardiovascular diseases","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-12-14T01:00:00Z","last_updated_date":"2006-12-14T01:00:00Z","reference_number":"EMEA/CHMP/EWP/498145/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-gender-differences-cardiovascular-diseases_en.pdf"},
    {"id":"38089","name":"Guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T11:37:00Z","last_updated_date":"2011-10-03T11:37:00Z","reference_number":"EMA/CHMP/167834/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-and-package-leaflet-radiopharmaceuticals_en.pdf"},
    {"id":"38090","name":"European Medicines Agency budget for 2010","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2010-01-11T01:00:00Z","last_updated_date":"2010-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2010_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/report/european-medicines-agency-budget-2010_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/report/european-medicines-agency-budget-2010_cs.pdf","da":"https://www.ema.europa.eu/da/documents/report/european-medicines-agency-budget-2010_da.pdf","de":"https://www.ema.europa.eu/de/documents/report/european-medicines-agency-budget-2010_de.pdf","et":"https://www.ema.europa.eu/et/documents/report/european-medicines-agency-budget-2010_et.pdf","el":"https://www.ema.europa.eu/el/documents/report/european-medicines-agency-budget-2010_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/report/european-medicines-agency-budget-2010_fr.pdf","it":"https://www.ema.europa.eu/it/documents/report/european-medicines-agency-budget-2010_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/report/european-medicines-agency-budget-2010_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/report/european-medicines-agency-budget-2010_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/report/european-medicines-agency-budget-2010_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/report/european-medicines-agency-budget-2010_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/report/european-medicines-agency-budget-2010_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/report/european-medicines-agency-budget-2010_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/report/european-medicines-agency-budget-2010_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/report/european-medicines-agency-budget-2010_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/report/european-medicines-agency-budget-2010_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/report/european-medicines-agency-budget-2010_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/report/european-medicines-agency-budget-2010_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/report/european-medicines-agency-budget-2010_sv.pdf"}},
    {"id":"38091","name":"Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients' and Consumers' Organisations meeting - February 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-02-05T16:00:00Z","last_updated_date":"2014-04-28T13:40:00Z","reference_number":"EMA/19425/2014","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-meeting-february-2014_en.pdf"},
    {"id":"38092","name":"Sodium oxybate (intravenous use): List of nationally authorised medicinal products - PSUSA/00010613/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T15:30:00Z","last_updated_date":"2018-05-23T15:36:00Z","reference_number":"EMA/312335/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-oxybate-intravenous-use-list-nationally-authorised-medicinal-products-psusa00010613201710_en.pdf"},
    {"id":"38098","name":"Presentation - European Medicines Agency reorganisation (Kornelia Grein)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-reorganisation-kornelia-grein_en.pdf"},
    {"id":"38099","name":"Assessment of the paediatric needs - Nephrology","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2006-12-01T01:00:00Z","last_updated_date":"2006-12-01T01:00:00Z","reference_number":"EMEA/13306/2007","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-nephrology_en.pdf"},
    {"id":"38101","name":"Draft list of references supporting the assessment of Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-10-20T02:00:00Z","last_updated_date":"2011-10-20T02:00:00Z","reference_number":"EMA/HMPC/337076/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-or-their-mixtures-flos-first-version_en.pdf"},
    {"id":"38103","name":"Withdrawal assessment report for Elmisol","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-07-18T02:00:00Z","last_updated_date":"2017-07-18T02:00:00Z","reference_number":"EMA/CHMP/824474/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-elmisol_en.pdf"},
    {"id":"38105","name":"EU/3/07/515: Public summary of positive opinion for orphan designation of tegafur, gimeracil, oteracil potassium for the treatment of gastric cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2011-03-28T02:00:00Z","reference_number":"EMEA/COMP/152488/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307515-public-summary-positive-opinion-orphan-designation-tegafur-gimeracil-oteracil-potassium-treatment-gastric-cancer_en.pdf"},
    {"id":"38107","name":"Committee for Advanced Therapies (CAT): March 2011 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-03-25T01:00:00Z","last_updated_date":"2011-07-07T02:00:00Z","reference_number":"EMA/CAT/229545/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-march-2011-meeting-monthly-report_en.pdf"},
    {"id":"38109","name":"CHMP summary of positive opinion for Nityr","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/CHMP/230825/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nityr_en.pdf"},
    {"id":"38111","name":"Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-11-29T10:15:00Z","last_updated_date":"2011-11-29T10:15:00Z","reference_number":"EMA/920913/2011","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-concentrate-autologous-bone-marrow-derived-mononuclear-cells-bm-mnc_en.pdf"},
    {"id":"38112","name":"VICH GL25: Biologicals: Testing of residual formaldehyde - Step 7","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-04-30T02:00:00Z","last_updated_date":"2002-04-30T02:00:00Z","reference_number":"CVMP/VICH/095/01-Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl25-biologicals-testing-residual-formaldehyde-step-7_en.pdf"},
    {"id":"38115","name":"European Medicines Agency action plan related to the European Commission’s recommendations on product information","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T12:00:00Z","last_updated_date":"2017-11-15T12:00:00Z","reference_number":"EMA/680018/2017","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-action-plan-related-european-commissions-recommendations-product-information_en.pdf"},
    {"id":"38117","name":"Presentation - Immunotherapies in melanoma: regulatory perspective (Jorge Camarero) - S2.3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunotherapies-melanoma-regulatory-perspective-jorge-camarero-s23_en.pdf"},
    {"id":"38118","name":"CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Draft advice","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag5-advice-european-medicines-agency-clinical-trial-advisory-group-legal-aspects-draft-advice_en.pdf"},
    {"id":"38119","name":"Melissae aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-09-01T02:00:00Z","last_updated_date":"1998-09-01T02:00:00Z","reference_number":"EMEA/MRL/281/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/melissae-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38123","name":"Parconazole: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-09-01T02:00:00Z","last_updated_date":"1998-09-01T02:00:00Z","reference_number":"EMEA/MRL/351/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/parconazole-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38128","name":"Final list of references supporting the assessment of Echinacea purpurea (L.) Moench., herba recens","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-04-13T02:00:00Z","last_updated_date":"2015-04-13T02:00:00Z","reference_number":"EMA/HMPC/261891/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"38129","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Gà¼nter Verheugen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-ga-14nter-verheugen_en.pdf"},
    {"id":"38130","name":"Letter from Thomas Là¶nngren 28-12-2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-03-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/letter-thomas-lapnngren-28-12-2010_en.pdf"},
    {"id":"38133","name":"Final assessment report on Species diureticae","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/HMPC/224754/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-species-diureticae_en.pdf"},
    {"id":"38136","name":"Assessment report for tolperisone-containing medicinal products","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T02:00:00Z","last_updated_date":"2013-04-02T02:00:00Z","reference_number":"EMA/753061/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-tolperisone-containing-medicinal-products_en.pdf"},
    {"id":"38137","name":"CHMP summary of opinion for Pemetrexed medac","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/596263/2015 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-pemetrexed-medac_en.pdf"},
    {"id":"38138","name":"Withdrawal assessment report for Kexxtone","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-03-04T01:00:00Z","last_updated_date":"2009-03-04T01:00:00Z","reference_number":"EMEA/12430/2009","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-kexxtone_en.pdf"},
    {"id":"38139","name":"Presentation - RMS and OMS: industry on-boarding to SPOR webinar with Industry Change Liaisons","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T16:20:00Z","last_updated_date":"2017-11-15T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rms-and-oms-industry-boarding-spor-webinar-industry-change-liaisons_en.pdf"},
    {"id":"38143","name":"New judicial decisions at odds with EMA’s efforts to allow access to documents on medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-09-29T18:00:00Z","last_updated_date":"2016-09-29T18:00:00Z","reference_number":"EMA/526600/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-judicial-decisions-odds-emas-efforts-allow-access-documents-medicines_en.pdf"},
    {"id":"38144","name":"Committee for medicinal products for veterinary use summary of opinion: Trocoxil: International Non-proprietary Names (INN): Mavacoxib","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2008-07-18T03:09:21Z","last_updated_date":"2008-07-18T03:09:21Z","reference_number":"EMEA/CVMP/333587/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-trocoxil-international-non-proprietary-names-inn-mavacoxib_en.pdf"},
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    {"id":"38149","name":"Guidelines and concept papers adopted during the CHMP meeting 20-23 July 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2015-07-29T12:00:00Z","last_updated_date":"2015-07-29T12:00:00Z","reference_number":"EMA/38572/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-20-23-july-2015_en.pdf"},
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    {"id":"38152","name":"Outline and objectives - Alex Tait","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:09:21Z","last_updated_date":"2009-06-23T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/outline-and-objectives-alex-tait_en.pdf"},
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    {"id":"38154","name":"EU/3/10/847: Public summary of opinion on orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII for the treatment of haemophilia A","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-07T01:00:00Z","last_updated_date":"2011-11-18T13:30:00Z","reference_number":"EMA/COMP/14316/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310847-public-summary-opinion-orphan-designation-pegylated-b-domain-deleted-sequence-modified-recombinant-human-factor-viii-treatment-haemophilia_en.pdf"},
    {"id":"38155","name":"Superseded opinion of the HMPC on a Community herbal monograph on Humulus lupulus L., flos - First version","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2016-01-21T01:00:00Z","last_updated_date":"2016-01-21T01:00:00Z","reference_number":"EMEA/HMPC/591021/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-humulus-lupulus-l-flos-first-version_en.pdf"},
    {"id":"38157","name":"Sample eligibility form - Patients and consumers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-07-10T13:47:00Z","last_updated_date":"2018-07-10T13:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sample-eligibility-form-patients-and-consumers_en.pdf"},
    {"id":"38158","name":"Public statement: Vasovist and nephrogenic systemic fibrosis (NSF)","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2007-02-07T01:09:27Z","last_updated_date":"2007-02-07T01:09:27Z","reference_number":"EMEA/49741/2007","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-vasovist-and-nephrogenic-systemic-fibrosis-nsf_en.pdf"},
    {"id":"38159","name":"Workshop report - Benefit-risk communication to medicines users: How can regulators best meet the information needs of patients and healthcare professionals?","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T15:45:00Z","last_updated_date":"2014-12-08T15:45:00Z","reference_number":"EMA/581546/2014","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-benefit-risk-communication-medicines-users-how-can-regulators-best-meet-information-needs-patients-and-healthcare-professionals_en.pdf"},
    {"id":"38160","name":"Agenda - First Stakeholders forum on the implementation of the new Pharmacovigilance legislation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2011-04-19T02:00:00Z","last_updated_date":"2011-04-19T02:00:00Z","reference_number":"EMA/280084/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-stakeholders-forum-implementation-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"38161","name":"Programme - Challenges for the approval of anti-cancer immunotherapeutic drugs","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-02-02T12:00:00Z","last_updated_date":"2016-02-03T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-challenges-approval-anti-cancer-immunotherapeutic-drugs_en.pdf"},
    {"id":"38164","name":"Opinion following an Article 29(4) referral for Bicaluplex and associated names International Non-Proprietary Name (INN): bicalutamide: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-11-23T00:08:21Z","last_updated_date":"2007-11-23T00:08:21Z","reference_number":"EMEA/433691/2007","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-294-referral-bicaluplex-and-associated-names-international-non-proprietary-name-inn-bicalutamide-background-information_sv.pdf"}},
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    {"id":"38181","name":"EU/3/03/150: Public summary of positive opinion for orphan designation of adenovirus-interferon gamma - coding DNA sequence for the treatment of cutaneous T cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-10-23T02:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/COMP/1326/2003 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303150-public-summary-positive-opinion-orphan-designation-adenovirus-interferon-gamma-coding-dna-sequence-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"38183","name":"Presentation - Pharmacovigilance – risk-benefit monitoring cycle. A global undertaking (Fergus Sweeney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-risk-benefit-monitoring-cycle-global-undertaking-fergus-sweeney_en.pdf"},
    {"id":"38190","name":"Declaration of interests - Kaarlo Hoppu","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-kaarlo-hoppu_en.pdf"},
    {"id":"38192","name":"Alfentanil: List of nationally authorised medicinal products - PSUSA/00000082/201509","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-10-17T19:40:09Z","reference_number":"EMA/387812/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/alfentanil-list-nationally-authorised-medicinal-products-psusa00000082201509_en.pdf"},
    {"id":"38196","name":"Organisational matters - CHMP May 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/CHMP/273712/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-may-2012_en.pdf"},
    {"id":"38198","name":"Agenda - 2017 European Union Good Clinical Practice Inspectors Working Group workshop","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-09-25T19:00:00Z","last_updated_date":"2017-09-25T19:00:00Z","reference_number":"EMA/195334/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2017-european-union-good-clinical-practice-inspectors-working-group-workshop_en.pdf"},
    {"id":"38199","name":"CHMP post-authorisation summary of positive opinion for Avastin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/CHMP/365686/2014","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-avastin_en.pdf-5"},
    {"id":"38200","name":"Committee for proprietary medicinal products June 2002 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2002-07-10T02:00:00Z","last_updated_date":"2002-07-10T02:00:00Z","reference_number":"EMEA/CPMP/2749/02","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-proprietary-medicinal-products-june-2002-plenary-meeting-monthly-report_en.pdf"},
    {"id":"38201","name":"Announcement of European Medicines Agency priorities for adverse drug reaction research – Seventh call, Seventh Framework Programme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-05-22T18:13:27Z","last_updated_date":"2012-05-22T18:13:27Z","reference_number":"EMA/281471/2012","document_url":"https://www.ema.europa.eu/en/documents/other/announcement-european-medicines-agency-priorities-adverse-drug-reaction-research-seventh-call-seventh-framework-programme_en.pdf"},
    {"id":"38204","name":"CVMP Risk Management Strategy - Managing the risk of the potential presence of replication competent endogenous retrovirus RD114 in starting materials and final products of feline and canine vaccines","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T17:00:00Z","last_updated_date":"2017-02-24T17:00:00Z","reference_number":"EMA/CVMP/IWP/592652/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/cvmp-risk-management-strategy-managing-risk-potential-presence-replication-competent-endogenous-retrovirus-rd114-starting-materials-and-final-products-feline-and-canine-vaccines_en.pdf"},
    {"id":"38206","name":"Scientific recommendation on classification of advanced-therapy medicinal products: Allogeneic bone-marrow-derived mesenchymal cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-05-21T19:15:00Z","last_updated_date":"2013-05-21T19:15:00Z","reference_number":"EMA/277400/2013","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-bone-marrow-derived-mesenchymal-cells_en.pdf"},
    {"id":"38209","name":"CHMP post-authorisation summary of positive opinion for Truvada (II-135)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/CHMP/804062/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-truvada-ii-135_en.pdf"},
    {"id":"38210","name":"Aluminium salicylate, basic (bovine, caprine, Equidae and rabbit) – after provisional maximum residue limits (MRLs): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2016-12-12T10:20:00Z","last_updated_date":"2016-12-12T10:20:00Z","reference_number":"EMA/CVMP/454104/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/aluminium-salicylate-basic-bovine-caprine-equidae-and-rabbit-after-provisional-maximum-residue-limits-mrls-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"38212","name":"Hamamelis virginiana (Use in veterinary homeopathy): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/689/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/hamamelis-virginiana-use-veterinary-homeopathy-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38213","name":"Final assessment report on Achillea millefolium L., flos","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-09-30T02:00:00Z","last_updated_date":"2011-09-30T02:00:00Z","reference_number":"EMA/HMPC/149343/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-achillea-millefolium-l-flos_en.pdf"},
    {"id":"38214","name":"Overview of comments received on 'Reflection paper on In-Vitro cultured chondrocyte containing products for cartilage repair of the knee’ (EMA/CAT/568181/2009)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-04T02:00:00Z","last_updated_date":"2010-06-04T02:00:00Z","reference_number":"EMA/CAT/65294/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-reflection-paper-vitro-cultured-chondrocyte-containing-products-cartilage-repair-knee-emacat5681812009_en.pdf"},
    {"id":"38216","name":"Presentation - Blueprint project: PD-L1 IUO assay characterization (Rasika Kalamegham) - S3.2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-08T02:00:00Z","last_updated_date":"2016-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-blueprint-project-pd-l1-iuo-assay-characterization-rasika-kalamegham-s32_en.pdf"},
    {"id":"38217","name":"CVMP summary of positive opinion for Versican Plus L4","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/CVMP/301792/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-versican-plus-l4_en.pdf"},
    {"id":"38218","name":"'A Scientific Perspective on the Future of Medicines' 11 March 2005 - Daniel Brasseur","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-03-11T00:09:21Z","last_updated_date":"2005-03-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/scientific-perspective-future-medicines-11-march-2005-daniel-brasseur_en.pdf"},
    {"id":"38223","name":"EU/3/08/539: Public summary of positive opinion for orphan designation of ammonium tetrathiomolybdate for the treatment of Wilson’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-10T02:00:00Z","last_updated_date":"2008-07-10T02:00:00Z","reference_number":"EMEA/COMP/82161/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308539-public-summary-positive-opinion-orphan-designation-ammonium-tetrathiomolybdate-treatment-wilsons-disease_en.pdf"},
    {"id":"38224","name":"Presentation - Challenges of measuring impact of new pharmacovigilance processes (Judith Sanabria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-measuring-impact-new-pharmacovigilance-processes-judith-sanabria_en.pdf"},
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    {"id":"38228","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Raxone (idebenone) for the treatment of Leber’s hereditary optic neuropathy","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-09-22T13:30:00Z","last_updated_date":"2015-09-22T13:30:00Z","reference_number":"EMA/COMP/473162/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-raxone-idebenone-treatment-lebers-hereditary-optic-neuropathy_en.pdf"},
    {"id":"38232","name":"Nimesulide - Article 107 procedures - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2010-04-08T02:00:00Z","last_updated_date":"2010-04-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/nimesulide-article-107-procedures-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nimesulide-article-107-procedures-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nimesulide-article-107-procedures-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nimesulide-article-107-procedures-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nimesulide-article-107-procedures-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nimesulide-article-107-procedures-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nimesulide-article-107-procedures-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nimesulide-article-107-procedures-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nimesulide-article-107-procedures-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nimesulide-article-107-procedures-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nimesulide-article-107-procedures-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nimesulide-article-107-procedures-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nimesulide-article-107-procedures-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nimesulide-article-107-procedures-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nimesulide-article-107-procedures-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nimesulide-article-107-procedures-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nimesulide-article-107-procedures-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nimesulide-article-107-procedures-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nimesulide-article-107-procedures-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nimesulide-article-107-procedures-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nimesulide-article-107-procedures-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nimesulide-article-107-procedures-annex-ii_sv.pdf"}},
    {"id":"38233","name":"EU/3/17/1865: Public summary of opinion on orphan designation: Estetrol for the treatment of neonatal encephalopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-13T02:00:00Z","last_updated_date":"2017-05-13T02:00:00Z","reference_number":"EMA/227698/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171865-public-summary-opinion-orphan-designation-estetrol-treatment-neonatal-encephalopathy_en.pdf"},
    {"id":"38234","name":"CHMP summary of opinion for Palonosetron Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/220588/2016 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-palonosetron-accord_en.pdf"},
    {"id":"38235","name":"Medicines granted a Community marketing authorisation under the centralised procedure since the November CHMP meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-01-05T01:00:00Z","last_updated_date":"2012-01-05T01:00:00Z","reference_number":"EMA/986798/2011","document_url":"https://www.ema.europa.eu/en/documents/other/medicines-granted-community-marketing-authorisation-under-centralised-procedure-november-chmp-meeting_en.pdf"},
    {"id":"38237","name":"EU/3/01/054: Public summary of positive opinion for orphan designation of sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleyl phosphatidylglycerol and palmitic acid for the treatment of meconium aspiration syndr...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/257/04 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301054-public-summary-positive-opinion-orphan-designation-sinapultide-dipalmitoylphosphatidylcholine-palmitoyl-oleyl-phosphatidylglycerol-and-palmitic-acid-treatment-meconium-aspiration-syndr_en.pdf"},
    {"id":"38238","name":"European Medicines Agency completes its review of Avastin used in breast cancer","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-16T01:00:00Z","last_updated_date":"2010-12-16T01:00:00Z","reference_number":"EMA/CHMP/815425/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-completes-its-review-avastin-used-breast-cancer_en.pdf"},
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    {"id":"38243","name":"EU/3/09/662: Public summary of positive opinion for orphan designationof 26 base single stranded phosphodiester DNA oligonucleotide for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMEA/COMP/445179/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309662-public-summary-positive-opinion-orphan-designationof-26-base-single-stranded-phosphodiester-dna-oligonucleotide-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"38244","name":"Summary of positive opinion for Clopidogrel Ratiopharm GmbH","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:00:00Z","last_updated_date":"2009-05-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/summary-positive-opinion-clopidogrel-ratiopharm-gmbh_en.pdf"},
    {"id":"38246","name":"Strensiq: European Medicines Agency recommends measures to ensure safe and effective use","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T14:00:00Z","last_updated_date":"2015-06-26T14:00:00Z","reference_number":"EMA/386551/2015","document_url":"https://www.ema.europa.eu/en/documents/medication-error/strensiq-european-medicines-agency-recommends-measures-ensure-safe-and-effective-use_en.pdf"},
    {"id":"38247","name":"Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-05T15:10:00Z","last_updated_date":"2018-04-10T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cover-note-extended-eudravigilance-medicinal-product-dictionary-xevmpd-substance-controlled-vocabulary-following-quality-control-exercise_en.doc"},
    {"id":"38248","name":"Public statement on Sprimeo: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2012-07-23T02:00:00Z","last_updated_date":"2012-07-23T02:00:00Z","reference_number":"EMA/328034/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-sprimeo-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"38249","name":"Micro Therapeutic Research Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"EMA/850878/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-review-started_en.pdf"},
    {"id":"38250","name":"Instructions for Visual Inspection: Herceptin Vials 150 mg","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-11-22T00:09:21Z","last_updated_date":"2006-11-22T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/instructions-visual-inspection-herceptin-vials-150-mg_en.pdf"},
    {"id":"38251","name":"Zonisamide hard capsules 25, 50 and 100 mg, orodispersible tablets 25, 50, 100 and 300 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-11-01T17:40:17Z","reference_number":"EMA/CHMP/159882/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/zonisamide-hard-capsules-25-50-and-100-mg-orodispersible-tablets-25-50-100-and-300-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"38252","name":"Press release: Committee for Orphan Medicinal Products June 2007 Meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-26T02:09:21Z","last_updated_date":"2007-06-26T02:09:21Z","reference_number":"EMEA/COMP/276840/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-committee-orphan-medicinal-products-june-2007-meeting_en.pdf"},
    {"id":"38254","name":"Methotrexate Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2018-04-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methotrexate-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"38255","name":"CHMP summary of positive opinion for Constella","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-09-21T02:00:00Z","last_updated_date":"2012-09-21T02:00:00Z","reference_number":"EMA/CHMP/604998/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-constella_en.pdf"},
    {"id":"38258","name":"Workshop on medicines for bees - Report","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/28057/2010","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-medicines-bees-report_en.pdf"},
    {"id":"38260","name":"Declaration of research interests (addendum) - Paolo Rossi","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T11:00:00Z","last_updated_date":"2012-11-21T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-research-interests-addendum-paolo-rossi_en.pdf"},
    {"id":"38261","name":"CHMP summary of positive opinion for Elebrato Ellipta","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-09-15T14:00:00Z","last_updated_date":"2017-09-15T14:00:00Z","reference_number":"EMA/CHMP/587955/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-elebrato-ellipta_en.pdf"},
    {"id":"38263","name":"Presentation - Communication on medicine shortages (Inga Abed)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-18T17:00:00Z","last_updated_date":"2013-07-18T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-medicine-shortages-inga-abed_en.pdf"},
    {"id":"38264","name":"Note for guidance on the clinical investigation of plasma derived antithrombin products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-01-17T01:00:00Z","last_updated_date":"2002-01-17T01:00:00Z","reference_number":"CPMP/BPWG/2220/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-clinical-investigation-plasma-derived-antithrombin-products_en.pdf"},
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    {"id":"38266","name":"Overview of comments received on 'Prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-04-07T02:00:00Z","last_updated_date":"2016-04-07T02:00:00Z","reference_number":"EMA/CHMP/162888/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-prasugrel-film-coated-tablets-5-and-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"38267","name":"Overview of comments on 'draft guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-08-14T13:25:00Z","last_updated_date":"2012-08-14T13:25:00Z","reference_number":"EMA/CHMP/448578/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-draft-guideline-core-summary-product-characteristics-and-package-leaflet-fludeoxyglucose-18f_en.pdf"},
    {"id":"38268","name":"Technetium (99mTc) bicisate : List of nationally authorised medicinal products - PSUSA/00002856/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-13T16:21:00Z","last_updated_date":"2017-06-13T16:25:00Z","reference_number":"EMA/375852/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/technetium-99mtc-bicisate-list-nationally-authorised-medicinal-products-psusa00002856201610_en.pdf"},
    {"id":"38269","name":"Etoricoxib - Article 31 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-06-09T02:08:21Z","last_updated_date":"2004-06-09T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_en.pdf-0","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_es.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_de.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_fr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_it.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_nl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_pt.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/etoricoxib-article-31-referral-annex-i-ii-iii_sv.pdf-0"}},
    {"id":"38270","name":"CHMP post-authorisation summary of positive opinion for Aptivus on 23 April 2009","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:09:21Z","last_updated_date":"2009-04-23T02:09:21Z","reference_number":"EMEA/CHMP/232469/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-aptivus-23-april-2009_en.pdf-0"},
    {"id":"38271","name":"EU/3/14/1294: Public summary of opinion on orphan designation: Sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH for the treatment of necrotising soft tissue infections","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T17:00:00Z","last_updated_date":"2015-05-13T17:00:00Z","reference_number":"EMA/COMP/357055/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141294-public-summary-opinion-orphan-designation-sodium-acetate-salt-synthetic-peptide-h-d-ala-ser-pro-met-leu-val-ala-tyr-asp-d-ala-oh-treatment-necrotising-soft-tissue-infections_en.pdf"},
    {"id":"38272","name":"Girolan Article-34 referral - Divergent position 2","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-15T02:00:00Z","last_updated_date":"2018-06-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/girolan-article-34-referral-divergent-position-2_en.pdf"},
    {"id":"38274","name":"Hydroxyzine Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-06-08T02:00:00Z","last_updated_date":"2015-06-08T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyzine-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyzine-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyzine-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyzine-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyzine-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyzine-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyzine-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyzine-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyzine-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyzine-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyzine-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyzine-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/hydroxyzine-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyzine-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyzine-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyzine-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyzine-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyzine-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyzine-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyzine-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyzine-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyzine-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyzine-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"38275","name":"Agenda - Sixty-third meeting of the Management Board, 11 June 2009","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2009-06-11T02:09:21Z","last_updated_date":"2009-06-11T02:09:21Z","reference_number":"EMEA/MB/45799/2009Adopted","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sixty-third-meeting-management-board-11-june-2009_en.pdf"},
    {"id":"38276","name":"Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring addressed to member states for Daclatasvir available for compassionate use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-02-03T10:40:00Z","last_updated_date":"2020-10-26T11:00:00Z","reference_number":"EMA/24463/2014","document_url":"https://www.ema.europa.eu/en/documents/other/conditions-use-conditions-distribution-and-patients-targeted-and-conditions-safety-monitoring-addressed-member-states-daclatasvir-available-compassionate-use_en.pdf"},
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    {"id":"38281","name":"EU/3/14/1259: Public summary of opinion on orphan designation: Amikacin sulfate for the treatment of nontuberculous mycobacterial lung disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-05-07T02:00:00Z","last_updated_date":"2014-10-08T02:00:00Z","reference_number":"EMA/COMP/97247/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141259-public-summary-opinion-orphan-designation-amikacin-sulfate-treatment-nontuberculous-mycobacterial-lung-disease_en.pdf"},
    {"id":"38283","name":"CVMP summary of opinion for Aivlosin 625 mg/g granules for use in drinking water for pigs","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-03-13T00:09:00Z","last_updated_date":"2009-03-13T00:09:00Z","reference_number":"EMEA/CVMP/106523/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-summary-opinion-aivlosin-625-mgg-granules-use-drinking-water-pigs_en.pdf"},
    {"id":"38284","name":"Artemether / lumefantrin (apart from the dispersible tablet) : List of nationally authorised medicinal products - PSUSA/00000236/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-13T11:25:00Z","last_updated_date":"2017-06-13T11:27:00Z","reference_number":"EMA/372458/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/artemether-lumefantrin-apart-dispersible-tablet-list-nationally-authorised-medicinal-products-psusa00000236201610_en.pdf"},
    {"id":"38286","name":"Assessment report for Cilazapril Teva","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-12T01:00:00Z","last_updated_date":"2013-03-12T01:00:00Z","reference_number":"EMA/691537/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-cilazapril-teva_en.pdf"},
    {"id":"38287","name":"Presentation - Interaction with healthcare professionals: Overview of involvement in EMA activities during 2013 (Gonzalo Calvo Rojas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-08T16:00:00Z","last_updated_date":"2014-07-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-healthcare-professionals-overview-involvement-ema-activities-during-2013-gonzalo-calvo-rojas_en.pdf"},
    {"id":"38288","name":"Oracea - Article 29 referral - Annex I, II, III, IV","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-08-21T02:08:21Z","last_updated_date":"2008-08-21T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/oracea-article-29-referral-annex-i-ii-iii-iv_sv.pdf"}},
    {"id":"38291","name":"Presentation - Heads of Medicines Agencies (HMA) update on Substance, Product, Organisation and Referential (SPOR) (Francisco Penaranda, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-heads-medicines-agencies-hma-update-substance-product-organisation-and-referential-spor-francisco-penaranda-ema_en.pdf"},
    {"id":"38292","name":"Questions and answers on the outcome of application to extend use of Menveo in children less than two years","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/253316/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-application-extend-use-menveo-children-less-two-years_en.pdf"},
    {"id":"38293","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: January 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-02-18T18:35:00Z","last_updated_date":"2015-02-18T18:35:00Z","reference_number":"EMA/786165/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-january-2015_en.pdf"},
    {"id":"38294","name":"EU/3/05/312: Public sumary of opinion  on orphan designation: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentao...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2013-03-11T12:15:00Z","reference_number":"EMA/COMP/246033/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305312-public-sumary-opinion-orphan-designation-1r2r4s-4-2r-2-3s6r7e9r10r12r14s15e17e19e21s23s26r27r34as-927-dihydroxy-1021-dimethoxy-6812142026-hexamethyl-15112829-pentao_en.pdf"},
    {"id":"38296","name":"Questions and answers on the withdrawal of the marketing application for Scintimun","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2010-03-15T01:00:00Z","reference_number":"EMEA/189992/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-scintimun_sv.pdf"}},
    {"id":"38297","name":"Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00000986/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-11T18:30:00Z","last_updated_date":"2018-06-11T18:32:51Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexamfetamine-list-nationally-authorised-medicinal-products-psusa00000986201709_en.pdf"},
    {"id":"38298","name":"Presentation - Process validation: Enhanced approach - continuous process verification (Brendan Hughes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T19:00:00Z","last_updated_date":"2013-04-22T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-process-validation-enhanced-approach-continuous-process-verification-brendan-hughes_en.pdf"},
    {"id":"38299","name":"1st EMEA/CPMP Workshop for Patients’ Organisations – Participants List","type":"other","status":"unknown","consultation_date":"","first_published_date":"2002-06-06T02:00:00Z","last_updated_date":"2002-06-06T02:00:00Z","reference_number":"EMEA/13971/02","document_url":"https://www.ema.europa.eu/en/documents/other/1st-emeacpmp-workshop-patients-organisations-participants-list_en.pdf"},
    {"id":"38301","name":"EU/3/16/1640: Public summary of opinion on orphan designation: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate for the tre...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-31T02:00:00Z","last_updated_date":"2016-05-31T02:00:00Z","reference_number":"EMA/COMP/254160/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161640-public-summary-opinion-orphan-designation-2-methyl-1-4-6-trifluoromethylpyridin-2-yl-6-2-trifluoromethylpyridin-4-ylamino-135-triazin-2-ylaminopropan-2-ol-methanesulfonate-tre_en.pdf"},
    {"id":"38304","name":"Workshop on access to clinical-trial data and transparency kicks off process towards proactive publication of data","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T13:44:13Z","last_updated_date":"2012-11-23T13:44:13Z","reference_number":"EMA/754763/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/workshop-access-clinical-trial-data-and-transparency-kicks-process-towards-proactive-publication-data_en.pdf"},
    {"id":"38305","name":"EU/3/07/469: Public summary of positive opinion for orphan designation of ciprofloxacin (inhalation use) for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-06-15T02:00:00Z","last_updated_date":"2011-11-18T01:00:00Z","reference_number":"EMEA/COMP/287903/2007 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307469-public-summary-positive-opinion-orphan-designation-ciprofloxacin-inhalation-use-treatment-cystic-fibrosis_en.pdf"},
    {"id":"38307","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous human adipose mesenchymal stromal cells, expanded in culture","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-28T13:00:00Z","last_updated_date":"2016-11-28T13:00:00Z","reference_number":"EMA/761560/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-human-adipose-mesenchymal-stromal-cells-expanded-culture_en.pdf"},
    {"id":"38308","name":"Technical specifications for open invitation to tender no. EMEA/2006/32/DIR, external member(s) of EMEA’s audit advisory committee","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-06-28T02:09:21Z","last_updated_date":"2006-06-28T02:09:21Z","reference_number":"EMEA/171058/2006","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-open-invitation-tender-no-emea200632dir-external-members-emeas-audit-advisory-committee_en.pdf"},
    {"id":"38310","name":"Presentation - Quantitative systems pharmacology in drug development\n\n- A pharma perspective - Break-out session 1 theme 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quantitative-systems-pharmacology-drug-development-pharma-perspective-break-out-session-1-theme-3_en.pdf"},
    {"id":"38311","name":"Questions and answers on the referral for Topamax and associated names topiramate tablets and capsules","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-06-25T02:08:21Z","last_updated_date":"2009-06-25T02:08:21Z","reference_number":"EMEA/CHMP/239500/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-topamax-and-associated-names-topiramate-tablets-and-capsules_en.pdf"},
    {"id":"38315","name":"Zinbryta Article-20 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-06-09T18:00:00Z","last_updated_date":"2017-09-04T18:00:00Z","reference_number":"EMA/PRAC/366037/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-timetable-procedure_en.pdf"},
    {"id":"38317","name":"EU/3/08/609: Public summary of positive opinion for orphan designation of adeno-associated viral vector serotype 5 containing the human ABCA4 gene for the treatment of Stargardt’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-03-20T01:00:00Z","last_updated_date":"2014-10-16T02:00:00Z","reference_number":"EMEA/COMP/567050/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308609-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-serotype-5-containing-human-abca4-gene-treatment-stargardts-disease_en.pdf"},
    {"id":"38318","name":"Adverse Drug Reaction (ADR) reporting - Patient guideline","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/adverse-drug-reaction-adr-reporting-patient-guideline_en.pdf"},
    {"id":"38322","name":"Agenda and registration form - The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-11-13T01:00:00Z","last_updated_date":"2017-11-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-new-eudravigilance-system-and-electronic-reporting-icsrs-isoich-e2br3-format-hands-training-course-berlin_en.pdf"},
    {"id":"38323","name":"Valnemulin: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/339/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/valnemulin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38325","name":"Superseded final community herbal monograph on Humulus lupulus L., flos - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2008-07-11T02:00:00Z","last_updated_date":"2014-08-07T02:00:00Z","reference_number":"EMEA/HMPC/513617/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-humulus-lupulus-l-flos-first-version_en.pdf"},
    {"id":"38326","name":"Summary report - EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T16:00:00Z","last_updated_date":"2017-02-03T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/summary-report-ema-european-biopharmaceutical-enterprises-ebe-fifth-annual-regulatory-conference-optimising-development-advanced-therapies-meet-patient-needs_en.pdf"},
    {"id":"38328","name":"Presentation - Use of physiologically based pharmacokinetics in simulating drug concentrations in paediatric populations: Case studies of midazolam and gabapentin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-physiologically-based-pharmacokinetics-simulating-drug-concentrations-paediatric-populations-case-studies-midazolam-and-gabapentin_en.pdf"},
    {"id":"38329","name":"Cobactan IV 4.5% powder and solvent for solution for injection Article-33 referral - Annex I, II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-12T02:00:00Z","last_updated_date":"2014-08-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/cobactan-iv-45-powder-and-solvent-solution-injection-article-33-referral-annex-i-ii_sv.pdf"}},
    {"id":"38330","name":"Benazepril: CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000313/201511","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-31T02:00:00Z","last_updated_date":"2016-10-18T14:01:15Z","reference_number":"EMA/581863/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/benazepril-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000313201511_en.pdf"},
    {"id":"38332","name":"Guideline on good pharmacogenomic practice - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-03-19T15:00:00Z","last_updated_date":"2018-07-13T16:00:00Z","reference_number":"EMA/CHMP/718998/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacogenomic-practice-first-version_en.pdf"},
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    {"id":"38337","name":"Opinion following an Article 40 referral for Suvaxyn Ery: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T01:59:00Z","last_updated_date":"2008-06-02T01:59:00Z","reference_number":"EMEA/532233/2007- Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-40-referral-suvaxyn-ery-background-information_sv.pdf"}},
    {"id":"38339","name":"VICH GL49: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-04-07T02:00:00Z","last_updated_date":"2015-02-27T17:30:00Z","reference_number":"EMA/CVMP/VICH/463202/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl49-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-animals-validation-analytical-methods-used-residue-depletion-studies_en.pdf"},
    {"id":"38340","name":"Presentation - Accelerated Development of VAccine beNefit-risk Collaboration in Europe (Malgorzata Leszczynska)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-12-11T01:00:00Z","last_updated_date":"2013-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accelerated-development-vaccine-benefit-risk-collaboration-europe-malgorzata-leszczynska_en.pdf"},
    {"id":"38342","name":"Committee for Advanced Therapies (CAT): February 2010 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"EMA/CAT/109681/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-february-2010-meeting-monthly-report_en.pdf"},
    {"id":"38343","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 24-26 February 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-03-04T15:00:00Z","last_updated_date":"2016-03-04T15:00:00Z","reference_number":"EMA/PDCO/142970/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-24-26-february-2016_en.pdf"},
    {"id":"38344","name":"Final overview of comments received on European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizoma- Revision 1","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2018-07-03T02:00:00Z","last_updated_date":"2018-07-03T02:00:00Z","reference_number":"EMA/HMPC/193919/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/final-overview-comments-received-european-union-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizoma-revision-1_en.pdf"},
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    {"id":"38346","name":"Report analysis on product information - European Medicines Agency Geriatric Medicines Strategy","type":"report","status":"unknown","consultation_date":"","first_published_date":"2013-10-17T17:30:00Z","last_updated_date":"2013-10-17T17:30:00Z","reference_number":"EMA/352652/2013","document_url":"https://www.ema.europa.eu/en/documents/report/report-analysis-product-information-european-medicines-agency-geriatric-medicines-strategy_en.pdf"},
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    {"id":"38348","name":"Questions and answers on the outcome of an application an application to extend use of Abilify in schizophrenia to 13 and 14 year olds","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2016-10-13T02:00:00Z","reference_number":"EMA/610465/2016","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-application-application-extend-use-abilify-schizophrenia-13-and-14-year-olds_en.pdf"},
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    {"id":"38353","name":"Consensus points - Workshop on haemophilia registries","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T18:00:00Z","last_updated_date":"2015-08-03T18:00:00Z","reference_number":"EMA/CHMP/BPWP/380896/2015","document_url":"https://www.ema.europa.eu/en/documents/other/consensus-points-workshop-haemophilia-registries_en.pdf"},
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    {"id":"38355","name":"Presentation - Immunology and immunotoxicity of nanomedicines, Jacques Descotes, Lyon University Hospitals, France","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunology-and-immunotoxicity-nanomedicines-jacques-descotes-lyon-university-hospitals-france_en.pdf"},
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    {"id":"38357","name":"European Medicines Agency workshop on multiplicity issues in clinical trials - Invitation for expressions of interest","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-06-21T02:00:00Z","last_updated_date":"2012-06-21T02:00:00Z","reference_number":"EMA/308884/2012","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-workshop-multiplicity-issues-clinical-trials-invitation-expressions-interest_en.pdf"},
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    {"id":"38360","name":"Summary of transfer of appropriations in the budget 2014: December 2014 - Management Board meeting: 18 December 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-22T15:00:00Z","last_updated_date":"2014-12-22T15:00:00Z","reference_number":"EMA/MB/694819/2014","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2014-december-2014-management-board-meeting-18-december-2014_en.pdf"},
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    {"id":"38404","name":"EU/3/14/1286: Public summary of opinion on orphan designation: Humanised Fc engineered monoclonal antibody against CD19 for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-16T02:00:00Z","last_updated_date":"2014-07-16T02:00:00Z","reference_number":"EMA/COMP/317254/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141286-public-summary-opinion-orphan-designation-humanised-fc-engineered-monoclonal-antibody-against-cd19-treatment-chronic-lymphocytic-leukaemiasmall-lymphocytic-lymphoma_en.pdf"},
    {"id":"38405","name":"New oral treatment for rheumatoid arthritis","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T01:00:00Z","last_updated_date":"2016-12-16T01:00:00Z","reference_number":"EMA/CHMP/856232/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-oral-treatment-rheumatoid-arthritis_en.pdf"},
    {"id":"38407","name":"Presentation - Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-21T01:00:00Z","last_updated_date":"2012-11-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-concept-paper-key-aspects-use-pharmacogenomic-methodologies-pharmacovigilance-evaluation-medicinal-products_en.pdf"},
    {"id":"38408","name":"Outcome of the workshop - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting factor concentrates (factor VIII and factor IX) wi...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-24T16:30:00Z","last_updated_date":"2014-01-24T16:30:00Z","reference_number":"EMA/789960/2013","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-workshop-joint-european-medicines-agency-european-directorate-quality-medicines-and-healthcare-workshop-characterisation-new-clotting-factor-concentrates-factor-viii-and-factor-ix-wi_en.pdf"},
    {"id":"38409","name":"Agenda - Demonstrating significant benefit of orphan medicines: concepts, methodology, and impact on access","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-09-04T02:00:00Z","last_updated_date":"2015-12-04T17:32:00Z","reference_number":"EMA/588712/2015 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-demonstrating-significant-benefit-orphan-medicines-concepts-methodology-and-impact-access_en.pdf"},
    {"id":"38411","name":"Bacitracin: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/451/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/bacitracin-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38414","name":"Presentation - Patient perspectives on monitoring effectiveness of risk minimisation measures in the field of multiple sclerosis (Christoph Thalheim)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-14T11:00:00Z","last_updated_date":"2015-12-14T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-perspectives-monitoring-effectiveness-risk-minimisation-measures-field-multiple-sclerosis-christoph-thalheim_en.pdf"},
    {"id":"38415","name":"Flupirtine Article-31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-28T19:04:00Z","last_updated_date":"2018-03-28T19:04:00Z","reference_number":"EMA/166943/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-assessment-report_en.pdf"},
    {"id":"38417","name":"Opinion following an Article 29(4) referral for Ciprofloxacine Kabi and associated names International Non-Proprietary Name (INN): Ciprofloxacin: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-01-25T00:08:21Z","last_updated_date":"2007-01-25T00:08:21Z","reference_number":"EMEA/CHMP/515890/2006","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-294-referral-ciprofloxacine-kabi-and-associated-names-international-non-proprietary-name-inn-ciprofloxacin-background-information_en.pdf"},
    {"id":"38418","name":"Publication of results-related information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-07-04T02:00:00Z","last_updated_date":"2015-02-19T17:15:00Z","reference_number":"EMA/428617/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/publication-results-related-information-paediatric-studies-submitted-under-article-45-regulation-ec-no-19012006-paediatric-regulation_en.pdf"},
    {"id":"38420","name":"Final European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-09-01T02:00:00Z","last_updated_date":"2017-09-01T02:00:00Z","reference_number":"EMA/HMPC/680626/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-prunus-africana-hook-f-kalkm-cortex_en.pdf"},
    {"id":"38423","name":"ICH: Q 4 B Annex 7: To note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on dissolution test general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-12-01T01:00:00Z","last_updated_date":"2008-12-01T01:00:00Z","reference_number":"EMEA/CHMP/ICH/645469/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-7-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-dissolution-test-general-chapter-step-3_en.pdf"},
    {"id":"38424","name":"Human medicines highlights - November 2011","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2011-12-02T13:13:00Z","last_updated_date":"2011-12-02T13:13:00Z","reference_number":"Issue 34","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-november-2011_en.pdf"},
    {"id":"38426","name":"Presentation - US FDA expedited programs and expanded access (Ke Liu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-us-fda-expedited-programs-and-expanded-access-ke-liu_en.pdf"},
    {"id":"38428","name":"Tobramycin VVB and associated names Article-29(4) referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-annex-ii_sv.pdf"}},
    {"id":"38429","name":"Superseded overview of comments on 'Community herbal monograph and list entry on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix' (EMEA/HMPC/244569/2006) and (EMEA/HMPC/83756/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-05-08T02:09:21Z","last_updated_date":"2014-10-06T02:09:21Z","reference_number":"EMEA/HMPC/591758/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-community-herbal-monograph-and-list-entry-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix-emeahmpc2445692006-and-emeahmpc837562007_en.pdf"},
    {"id":"38430","name":"Questions and answers on the refusal of the marketing authorisation for Istodax (romidepsin) - Outcome of re-examination","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"EMA/725439/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-istodax-romidepsin-outcome-re-examination_sv.pdf"}},
    {"id":"38432","name":"Presentation - Health Canada experience with measuring the impact of pharmacovigilance (John Patrick Stewart)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-health-canada-experience-measuring-impact-pharmacovigilance-john-patrick-stewart_en.pdf"},
    {"id":"38433","name":"Validation of biomarkers in HIV - Michael D. Hughes","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2005-12-16T00:09:21Z","last_updated_date":"2005-12-16T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/validation-biomarkers-hiv-michael-d-hughes_en.pdf"},
    {"id":"38435","name":"Novantrone Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/novantrone-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/novantrone-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/novantrone-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/novantrone-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/novantrone-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/novantrone-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/novantrone-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/novantrone-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/novantrone-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/novantrone-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/novantrone-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/novantrone-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/novantrone-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/novantrone-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/novantrone-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/novantrone-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/novantrone-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/novantrone-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/novantrone-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/novantrone-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/novantrone-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/novantrone-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/novantrone-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"38439","name":"European Medicines Agency Management Board re-elects Pat O'Mahony as chair","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2010-06-18T02:00:00Z","reference_number":"EMA/MB/376103/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-management-board-re-elects-pat-omahony-chair_en.pdf"},
    {"id":"38440","name":"Presentation - PDCO perspectives & proposals Enpr-EMA coordinating group (A. Siapkara, C. Male)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-perspectives-proposals-enpr-ema-coordinating-group-siapkara-c-male_en.pdf"},
    {"id":"38441","name":"Presentation - The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium project: Work package 5: Benefit-risk integration and representation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-07-06T14:00:00Z","last_updated_date":"2012-07-06T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacoepidemiological-research-outcomes-therapeutics-european-consortium-project-work-package-5-benefit-risk-integration-and-representation_en.pdf"},
    {"id":"38444","name":"Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-02-03T16:30:00Z","last_updated_date":"2017-02-03T16:30:00Z","reference_number":"EMA/CHMP/39283/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-and-package-leaflet-nanocolloidal-technetium-99mtc-albumin-first-version_en.pdf"},
    {"id":"38446","name":"Mecillinam: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-07-01T02:00:00Z","last_updated_date":"1998-07-01T02:00:00Z","reference_number":"EMEA/MRL/462/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/mecillinam-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38448","name":"PDCO meeting highlights 14-16 April 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2010-04-22T02:00:00Z","reference_number":"EMA/PDCO/226811/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-14-16-april-2010_en.pdf"},
    {"id":"38449","name":"Presentation - The value of a Neonatal Consortium - A regulators perspective (Ralph Bax)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-value-neonatal-consortium-regulators-perspective-ralph-bax_en.pdf"},
    {"id":"38450","name":"EU/3/13/1157: Public summary of opinion on orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for the treatment of follicular lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-16T13:00:00Z","last_updated_date":"2021-05-31T18:00:00Z","reference_number":"EMA/COMP/411861/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131157-public-summary-opinion-orphan-designation-s-3-1-9h-purin-6-ylaminoethyl-8-chloro-2-phenylisoquinolin-12h-one-treatment-follicular-lymphoma_en.pdf"},
    {"id":"38452","name":"Final opinion of the Committee for proprietary medicinal products in accordance with Article 12 of Directive 75/319/EEC as amended for Zagam 200mg and Annex","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1996-05-06T02:08:21Z","last_updated_date":"1996-05-06T02:08:21Z","reference_number":"CPMP/835/95","document_url":"https://www.ema.europa.eu/en/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-200mg-and-annex_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-200mg-and-annex_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-200mg-and-annex_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/final-opinion-committee-proprietary-medicinal-products-accordance-article-12-directive-75319eec-amended-zagam-200mg-and-annex_fr.pdf"}},
    {"id":"38453","name":"Presentation - Public website of side effects (V. Newbould)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-website-side-effects-v-newbould_en.pdf"},
    {"id":"38454","name":"European Medicines Agency updates on pandemic influenza","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-02-19T01:00:00Z","last_updated_date":"2010-02-19T01:00:00Z","reference_number":"EMA/94706/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-updates-pandemic-influenza_en.pdf"},
    {"id":"38455","name":"Presentation - EnprEMA network perspectives (M. Turner, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enprema-network-perspectives-m-turner-ema_en.pdf"},
    {"id":"38456","name":"Presentation - Chimeric antigen receptor (CAR)-T cells (David Lebwohl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chimeric-antigen-receptor-car-t-cells-david-lebwohl_en.pdf"},
    {"id":"38458","name":"Outcome of public consultation on new EMEA transparency","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2000-06-09T02:00:00Z","last_updated_date":"2000-06-09T02:00:00Z","reference_number":"EMEA/D/16906/00","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-public-consultation-new-emea-transparency_en.pdf"},
    {"id":"38463","name":"Final list of references supporting the assessment of Angelica sinensis (Oliv.) Diels, radix - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-11-25T01:00:00Z","last_updated_date":"2013-11-25T01:00:00Z","reference_number":"EMA/HMPC/681358/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
    {"id":"38464","name":"EU/3/07/518: Public summary of positive opinion for orphan designation of methyl 4, 6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3, 4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carbamate for the treatment of pulmonary arteria...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2022-06-14T17:00:00Z","reference_number":"EMEA/COMP/35953/2008 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307518-public-summary-positive-opinion-orphan-designation-methyl-4-6-diamino-2-1-2-fluorobenzyl-1h-pyrazolo-3-4-bpyridine-3-yl-5-pyrimidinylmethylcarbamate-treatment-pulmonary-arteria_en.pdf"},
    {"id":"38465","name":"Short-acting beta-agonists Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-30T01:00:00Z","last_updated_date":"2012-11-30T01:00:00Z","reference_number":"EMA/757433/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/short-acting-beta-agonists-article-31-referral-review-started_en.pdf"},
    {"id":"38466","name":"CHMP summary of positive opinion for Temomedac","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-11-19T01:00:00Z","last_updated_date":"2009-11-19T01:00:00Z","reference_number":"EMEA/CHMP/567028/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-temomedac_en.pdf"},
    {"id":"38467","name":"EU/3/17/1920: Public summary of opinion on orphan designation : Cannabidiol for the treatment of West syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-08T15:38:00Z","last_updated_date":"2018-01-08T15:38:00Z","reference_number":"EMA/625004/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171920-public-summary-opinion-orphan-designation-cannabidiol-treatment-west-syndrome_en.pdf"},
    {"id":"38470","name":"Overview of comments received on guideline on requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza EMEA/CVMP/IWP/222624/2006","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-05-02T02:00:00Z","last_updated_date":"2007-05-02T02:00:00Z","reference_number":"EMEA/146160/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-requirements-authorisation-under-exceptional-circumstances-vaccines-use-birds-against-avian-influenza-emeacvmpiwp2226242006_en.pdf"},
    {"id":"38471","name":"CHMP summary of positive opinion for Caprelsa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-11-18T10:45:00Z","last_updated_date":"2011-11-18T10:45:00Z","reference_number":"EMA/CHMP/817228/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-caprelsa_en.pdf"},
    {"id":"38473","name":"CHMP post-authorisation summary of positive opinion for Kalydeco (II-63-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/506642/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kalydeco-ii-63-g_en.pdf"},
    {"id":"38477","name":"Superseded list of references supporting the assessment of Juniperi pseudo-fructus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-02-16T01:00:00Z","last_updated_date":"2023-06-13T01:00:00Z","reference_number":"EMA/HMPC/442959/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-juniperi-pseudo-fructus_en.pdf"},
    {"id":"38481","name":"COMP meeting report on the review of applications for orphan designation: July 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-07-22T16:05:00Z","last_updated_date":"2014-09-09T15:30:00Z","reference_number":"EMA/COMP/396320/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-july-2014_en.pdf"},
    {"id":"38483","name":"Draft assessment report on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/461156/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-urtica-dioica-l-urtica-urens-l-their-hybrids-or-their-mixtures-radix-first-version_en.pdf"},
    {"id":"38484","name":"Policy 72: European Medicines Agency policy on handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human a...","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2017-04-10T12:00:00Z","last_updated_date":"2022-04-20T10:00:00Z","reference_number":"EMA/283205/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/policy-72-european-medicines-agency-policy-handling-information-external-sources-disclosing-alleged-improprieties-concerning-ema-activities-related-authorisation-supervision-and-maintenance-human_en.pdf"},
    {"id":"38485","name":"Committee for Advanced Therapies (CAT): March 2010 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/CAT/178413/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-march-2010-meeting-monthly-report_en.pdf"},
    {"id":"38488","name":"Opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 60mg and Annexes A and B","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-01-22T00:08:21Z","last_updated_date":"1998-01-22T00:08:21Z","reference_number":"CPMP/255/98-EN","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-60mg-and-annexes-and-b_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-60mg-and-annexes-and-b_es.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-60mg-and-annexes-and-b_de.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-12-council-directive-75319eec-amended-terfenadine-60mg-and-annexes-and-b_fr.pdf"}},
    {"id":"38491","name":"Key milestones of EMA interactions with healthcare professionals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T01:00:00Z","last_updated_date":"2017-08-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/key-milestones-ema-interactions-healthcare-professionals_en.pdf"},
    {"id":"38492","name":"Annex III: Relevant Sections of the Summary of Product Characteristics and Package Leaflet - Modified-released oral opioids","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-07-23T02:00:00Z","last_updated_date":"2010-07-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/annex-iii-relevant-sections-summary-product-characteristics-and-package-leaflet-modified-released-oral-opioids_en.pdf"},
    {"id":"38494","name":"Spectinomycin: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-01-01T01:00:00Z","last_updated_date":"1996-01-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/spectinomycin-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38497","name":"Overview of comments received on 'draft sunitinib product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116836/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-sunitinib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"38499","name":"Abamectin: Summary Report (1) Updated - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2002-05-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/abamectin-summary-report-1-updated-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38500","name":"Committee for medicinal products for human use, post-authorisation summary of positive opinion for Tarceva on 14 December 2006","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2008-01-09T01:00:00Z","last_updated_date":"2008-01-09T01:00:00Z","reference_number":"EMEA/CHMP/511166/2006","document_url":"https://www.ema.europa.eu/en/documents/smop/committee-medicinal-products-human-use-post-authorisation-summary-positive-opinion-tarceva-14-december-2006_en.pdf"},
    {"id":"38502","name":"ICMRA - Mapping of crisis management initiatives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-01-09T13:20:00Z","last_updated_date":"2017-01-09T13:20:00Z","reference_number":"EMA/580633/2015","document_url":"https://www.ema.europa.eu/en/documents/other/icmra-mapping-crisis-management-initiatives_en.pdf"},
    {"id":"38503","name":"Presentation - Recent learnings from the IMI WEB-RADR project (Phil Tregunno)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-11-17T01:00:00Z","last_updated_date":"2016-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recent-learnings-imi-web-radr-project-phil-tregunno_en.pdf"},
    {"id":"38504","name":"Opinion of the HMPC on a community herbal monograph on Juglans regia L., folium","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2014-01-17T01:00:00Z","last_updated_date":"2014-01-17T01:00:00Z","reference_number":"EMA/HMPC/420309/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-juglans-regia-l-folium_en.pdf"},
    {"id":"38505","name":"Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Opatanol","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-02-23T01:00:00Z","last_updated_date":"2006-02-23T01:00:00Z","reference_number":"EMEA/60142/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-opatanol_sv.pdf"}},
    {"id":"38507","name":"Organisational matters - CHMP meeting of 17-20 September 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-09-24T10:44:00Z","last_updated_date":"2012-09-24T10:44:00Z","reference_number":"EMA/CHMP/539765/2012","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-17-20-september-2012_en.pdf"},
    {"id":"38509","name":"Factor VIII Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/factor-viii-article-31-referral-notification_en.pdf"},
    {"id":"38512","name":"Public statement on the current shortage of radiopharmaceuticals in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2008-10-01T02:09:21Z","last_updated_date":"2008-10-01T02:09:21Z","reference_number":"EMEA/501698/2008","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-current-shortage-radiopharmaceuticals-european-union_en.pdf"},
    {"id":"38513","name":"Presentation - Consumption of antimicrobials in food animals outside the European Union / European Economic Area (Hilde Kruse)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-15T13:00:00Z","last_updated_date":"2013-04-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-consumption-antimicrobials-food-animals-outside-european-union-european-economic-area-hilde-kruse_en.pdf"},
    {"id":"38516","name":"Annexes to CPMP/ICH/283/95 impurities: Guideline for residual solvents andCVMP/VICH/502/99 guideline on impurities: Residual solvents - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-02-10T01:00:00Z","last_updated_date":"2013-03-12T12:05:00Z","reference_number":"CPMP/QWP/450/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/annexes-cpmpich28395-impurities-guideline-residual-solvents-andcvmpvich50299-guideline-impurities-residual-solvents-revision-1_en.pdf"},
    {"id":"38518","name":"High level business consultancy EMA/2013/23/FI - Letter of invitation to tender","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"EMA/553009/2013","document_url":"https://www.ema.europa.eu/en/documents/other/high-level-business-consultancy-ema201323fi-letter-invitation-tender_en.pdf"},
    {"id":"38520","name":"Omega-3 acid ethyl esters - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T13:00:00Z","last_updated_date":"2018-03-23T13:00:00Z","reference_number":"EMEA/H/A-31/1464","document_url":"https://www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-notification_en.pdf"},
    {"id":"38521","name":"Pramiracetam: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00002492/201409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-08-07T12:00:00Z","last_updated_date":"2016-10-17T18:48:34Z","reference_number":"EMA/536968/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/pramiracetam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002492201409_en.pdf"},
    {"id":"38522","name":"Meeting highlights from the Paediatric Committee: 4 - 6 March 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-03-13T01:00:00Z","last_updated_date":"2009-03-13T01:00:00Z","reference_number":"EMEA/PDCO/118305/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-4-6-march-2009_en.pdf"},
    {"id":"38524","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Genetically modified adenovirus coding for human granulocyte-macrophage colony stimulating factor\n\n(GM-CSF)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2014-02-12T16:30:00Z","last_updated_date":"2014-02-12T16:30:00Z","reference_number":"EMA/75932/2014","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-genetically-modified-adenovirus-coding-human-granulocyte-macrophage-colony-stimulating-factor-gm-csf_en.pdf"},
    {"id":"38525","name":"Guidance on format of the risk-management plan in the European Union part V: Risk-minimisation measures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-08T18:00:00Z","last_updated_date":"2012-11-08T18:00:00Z","reference_number":"EMA/715019/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-v-risk-minimisation-measures_en.pdf"},
    {"id":"38527","name":"EU/3/15/1502: Public summary of opinion on orphan designation: Trehalose for the treatment of spinocerebellar ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"EMA/COMP/345422/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151502-public-summary-opinion-orphan-designation-trehalose-treatment-spinocerebellar-ataxia_en.pdf"},
    {"id":"38528","name":"Seventeenth pandemic pharmacovigilance update","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-05-05T02:00:00Z","last_updated_date":"2010-05-05T02:00:00Z","reference_number":"EMA/281958/2010","document_url":"https://www.ema.europa.eu/en/documents/report/seventeenth-pandemic-pharmacovigilance-update_en.pdf"},
    {"id":"38529","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products, 23-24 March 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-03-25T00:09:21Z","last_updated_date":"2004-03-25T00:09:21Z","reference_number":"EMEA/CPMP/1303/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-23-24-march-2004_en.pdf"},
    {"id":"38531","name":"Agenda - Programme - Workshop on veterinary regulatory support for micro, small and medium-sized enterprises (SMEs)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-10-09T13:00:00Z","last_updated_date":"2013-11-12T12:00:00Z","reference_number":"EMA/339258/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-programme-workshop-veterinary-regulatory-support-micro-small-and-medium-sized-enterprises-smes_en.pdf"},
    {"id":"38534","name":"Overview of comments received on questions and answers on the application of the so-called 'Sunset clause' to centrally authorised medicinal products","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-02-23T01:00:00Z","last_updated_date":"2006-02-23T01:00:00Z","reference_number":"EMEA/424409/2005","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/overview-comments-received-questions-and-answers-application-so-called-sunset-clause-centrally-authorised-medicinal-products_en.pdf"},
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    {"id":"38551","name":"Bilastine: List of nationally authorised medicinal products - PSUSA/00003163/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-11-20T13:10:00Z","last_updated_date":"2017-11-20T13:10:00Z","reference_number":"EMA/764254/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/bilastine-list-nationally-authorised-medicinal-products-psusa00003163201703_en.pdf"},
    {"id":"38553","name":"Agenda and registration form - EudraVigilance training on electronic reporting of Individual Case Safety Reports in the European Economic Area (London, UK)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-29T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-eudravigilance-training-electronic-reporting-individual-case-safety-reports-european-economic-area-london-uk_en.pdf"},
    {"id":"38555","name":"First-in-class treatment to lower cholesterol","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-05-22T02:00:00Z","last_updated_date":"2015-05-22T02:00:00Z","reference_number":"EMA/CHMP/338105/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-class-treatment-lower-cholesterol_en.pdf"},
    {"id":"38557","name":"Public hearing on Valproate - Summary of safety concerns and list of questions for the public hearing on Valproate","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-07-11T14:00:00Z","last_updated_date":"2017-07-11T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/public-hearing-valproate-summary-safety-concerns-and-list-questions-public-hearing-valproate_en.pdf"},
    {"id":"38559","name":"List of participants - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Workshop...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T02:00:00Z","last_updated_date":"2014-04-28T02:00:00Z","reference_number":"EMA/71682/2014","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf-2"},
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    {"id":"38562","name":"Committee on Herbal Medicinal Products (HMPC): Meeting report, 14 January 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-02-02T01:00:00Z","last_updated_date":"2010-02-02T01:00:00Z","reference_number":"EMA/HMPC/2974/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-herbal-medicinal-products-hmpc-meeting-report-14-january-2010_en.pdf"},
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    {"id":"38570","name":"Zinbryta Article-20 procedure - Assessment report on provisional measures","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-14T14:46:00Z","last_updated_date":"2018-03-14T14:46:00Z","reference_number":"EMA/159031/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-assessment-report-provisional-measures_en.pdf"},
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    {"id":"38584","name":"EU/3/13/1142: Public summary of opinion on orphan designation: Adenovirus associated viral vector serotype 5 containing the human pde6β gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-07-11T14:00:00Z","last_updated_date":"2015-03-10T13:00:00Z","reference_number":"EMA/COMP/307456/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131142-public-summary-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-5-containing-human-pde6i2-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"38585","name":"Final European Union herbal monograph on Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/HMPC/674139/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus_en.pdf"},
    {"id":"38588","name":"Concept paper on the need for the development of a paediatric addendum to the chmp guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-01-22T01:00:00Z","last_updated_date":"2009-01-22T01:00:00Z","reference_number":"EMEA/CHMP/EWP/644261/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-development-paediatric-addendum-chmp-guideline-clinical-investigations-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"38589","name":"Opinion following an Article 35 referral for all veterinary medicinal products containing systemically administered (parenteral and oral) 3rd and 4th generation cephalosporins intended for use in food producing 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    {"id":"38590","name":"Presentation - Good-manufacturing-practice (GMP) issues for start-ups, quality in the supply chain and role of the qualified person (QP) (Patrick Costello)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-15T02:00:00Z","last_updated_date":"2014-04-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-manufacturing-practice-gmp-issues-start-ups-quality-supply-chain-and-role-qualified-person-qp-patrick-costello_en.pdf"},
    {"id":"38591","name":"Guidelines and concept papers adopted during the CHMP meeting 14-17 December 2015","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-01-05T13:30:00Z","last_updated_date":"2016-01-05T13:30:00Z","reference_number":"EMA/38806/2015","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-14-17-december-2015_en.pdf"},
    {"id":"38593","name":"European Commission - Canada mutual recognition agreement: Sectoral annex on good manufacturing practices - Eighth joint sectoral group meeting update on the operation of the sectoral annex","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-06-07T02:00:00Z","last_updated_date":"2004-06-07T02:00:00Z","reference_number":"EMEA/INS/MRA/214440/2006","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-canada-mutual-recognition-agreement-sectoral-annex-good-manufacturing-practices-eighth-joint-sectoral-group-meeting-update-operation-sectoral-annex_en.pdf"},
    {"id":"38595","name":"Activities of former EMA Executive Director Thomas Là¶nngren","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-03-21T01:00:00Z","last_updated_date":"2011-03-21T01:00:00Z","reference_number":"EMA/222199/2011 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/activities-former-ema-executive-director-thomas-lapnngren_en.pdf"},
    {"id":"38596","name":"Public summary of the evaluation of a proposed product-specific\n\nwaiver: Ibandronic acid (in combination with calcium (carbonate) / cholecalciferol) for combination treatment of osteoporosis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/69490/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-ibandronic-acid-combination-calcium-carbonate-cholecalciferol-combination-treatment-osteoporosis_en.pdf"},
    {"id":"38599","name":"Points to consider on the need for assessment of reproductive toxicity of human insulin analogues","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-03-01T01:00:00Z","last_updated_date":"2002-03-01T01:00:00Z","reference_number":"CPMP/SWP/2600/01 Final","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-need-assessment-reproductive-toxicity-human-insulin-analogues_en.pdf"},
    {"id":"38600","name":"Krka, d.d., Novo mesto withdraws its marketing authorisation application for Desloratadine Krka (desloratadine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-10-19T02:00:00Z","last_updated_date":"2011-10-19T02:00:00Z","reference_number":"EMA/840073/2011 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/krka-dd-novo-mesto-withdraws-its-marketing-authorisation-application-desloratadine-krka-desloratadine_en.pdf"},
    {"id":"38604","name":"Download EPS - Species pictograms - Rabbit","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-11-25T01:00:00Z","last_updated_date":"2016-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/download-eps-species-pictograms-rabbit_en.zip"},
    {"id":"38607","name":"CHMP summary of positive opinion for Adasuve","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"EMA/778608/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-adasuve_en.pdf"},
    {"id":"38609","name":"Committee for medicinal products for veterinary use post-authoriastion summary of opinion: Flexicam: International Non-proprietary Name (INN): Meloxicam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-17T03:09:21Z","last_updated_date":"2014-05-20T03:09:21Z","reference_number":"EMEA/CVMP/512816/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/committee-medicinal-products-veterinary-use-post-authoriastion-summary-opinion-flexicam-international-non-proprietary-name-inn-meloxicam_en.pdf"},
    {"id":"38610","name":"Zafirlukast: List of nationally authorised medicinal products - PSUSA/00003138/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-05T14:00:00Z","last_updated_date":"2016-10-17T20:16:37Z","reference_number":"EMA/546104/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/zafirlukast-list-nationally-authorised-medicinal-products-psusa00003138201512_en.pdf"},
    {"id":"38613","name":"Presentation - EMA communication perception survey (E. Scanlan, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-communication-perception-survey-e-scanlan-ema_en.pdf"},
    {"id":"38614","name":"Presentation - Summaries of risk management plan (Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-07-30T12:00:00Z","last_updated_date":"2014-07-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summaries-risk-management-plan-juan-garcia-burgos_en.pdf"},
    {"id":"38615","name":"Presentation - Interaction with healthcare professionals: Overview of  involvement in EMA activities during 2015 (Ivana Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-healthcare-professionals-overview-involvement-ema-activities-during-2015-ivana-silva_en.pdf"},
    {"id":"38616","name":"EMEA prepares for entry into force of new legislation on paediatric medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-01-12T01:00:00Z","last_updated_date":"2007-01-12T01:00:00Z","reference_number":"EMEA/9224/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-prepares-entry-force-new-legislation-paediatric-medicines_en.pdf"},
    {"id":"38617","name":"Questions and answers on the withdrawal of the marketing application for Ramelteon","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-10-07T02:00:00Z","last_updated_date":"2008-10-07T02:00:00Z","reference_number":"EMEA/CHMP/502946/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-ramelteon_sv.pdf"}},
    {"id":"38618","name":"Pre-qualification questionnaire (PQQ) for a restricted tender procedure organised by the European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-20T11:30:00Z","last_updated_date":"2013-03-20T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pre-qualification-questionnaire-pqq-restricted-tender-procedure-organised-european-medicines-agency_en.doc"},
    {"id":"38621","name":"Triggers for audits of good laboratory practice (GLP) studies","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T14:20:00Z","last_updated_date":"2015-12-21T14:20:00Z","reference_number":"EMA/89741/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/triggers-audits-good-laboratory-practice-glp-studies_en.pdf"},
    {"id":"38622","name":"Celvapan: Package leaflet","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-29T02:00:00Z","last_updated_date":"2010-03-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/celvapan-package-leaflet_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/celvapan-package-leaflet_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/celvapan-package-leaflet_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/celvapan-package-leaflet_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/celvapan-package-leaflet_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/celvapan-package-leaflet_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/celvapan-package-leaflet_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/celvapan-package-leaflet_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/celvapan-package-leaflet_fr.pdf","it":"https://www.ema.europa.eu/it/documents/other/celvapan-package-leaflet_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/celvapan-package-leaflet_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/celvapan-package-leaflet_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/celvapan-package-leaflet_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/celvapan-package-leaflet_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/celvapan-package-leaflet_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/celvapan-package-leaflet_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/celvapan-package-leaflet_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/celvapan-package-leaflet_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/celvapan-package-leaflet_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/celvapan-package-leaflet_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/celvapan-package-leaflet_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/celvapan-package-leaflet_sv.pdf"}},
    {"id":"38623","name":"EU/3/03/158: Public summary of positive opinion for orphan designation of recombinant human arylsulfatase A for the treatment of metachromatic leukodystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2011-11-18T13:30:00Z","reference_number":"EMEA/COMP/1378/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303158-public-summary-positive-opinion-orphan-designation-recombinant-human-arylsulfatase-treatment-metachromatic-leukodystrophy_en.pdf"},
    {"id":"38624","name":"Draft assessment report on Citrus bergamia Risso et Poiteau, aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-10-19T18:30:00Z","last_updated_date":"2011-10-19T18:30:00Z","reference_number":"EMA/HMPC/56155/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-citrus-bergamia-risso-et-poiteau-aetheroleum_en.pdf"},
    {"id":"38627","name":"Human autologous stromal vascular fraction (SVF) cells and human autologous adipose-derived mesenchymal stem cells (ADSC) cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2018-02-13T10:12:00Z","reference_number":"EMA/298458/2016","document_url":"https://www.ema.europa.eu/en/documents/report/human-autologous-stromal-vascular-fraction-svf-cells-and-human-autologous-adipose-derived-mesenchymal-stem-cells-adsc-cells_en.pdf"},
    {"id":"38629","name":"ICH: Q 5 E: Comparability of biotechnological/biological products - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-06-01T02:00:00Z","last_updated_date":"2005-06-01T02:00:00Z","reference_number":"CPMP/ICH/5721/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-e-comparability-biotechnologicalbiological-products-step-5_en.pdf"},
    {"id":"38633","name":"Zydelig Article-20 procedure - Annex IV - Scientific conclusions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-02T12:00:00Z","last_updated_date":"2016-05-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zydelig-article-20-procedure-annex-iv-scientific-conclusions_sv.pdf"}},
    {"id":"38637","name":"PRAC recommends product information of zolpidem be updated with new advice to minimise the risk of next-morning impaired driving ability and mental alertness","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T01:00:00Z","last_updated_date":"2014-03-07T01:00:00Z","reference_number":"EMA/129598/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-product-information-zolpidem-be-updated-new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness_en.pdf"},
    {"id":"38639","name":"Note for guidance on maximum shelf-life for sterile products for human use after first opening or following reconstitution","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1998-01-28T01:00:00Z","last_updated_date":"1998-01-28T01:00:00Z","reference_number":"CPMP/QWP/159/96","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/note-guidance-maximum-shelf-life-sterile-products-human-use-after-first-opening-or-following-reconstitution_en.pdf"},
    {"id":"38641","name":"Initial notices for parallel distribution – 2012","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T13:11:00Z","last_updated_date":"2013-07-22T13:11:00Z","reference_number":"EMA/402820/2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/initial-notices-parallel-distribution-2012_en.pdf"},
    {"id":"38644","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 15-18 November 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-11-18T01:00:00Z","last_updated_date":"2004-11-18T01:00:00Z","reference_number":"EMEA/152989/2004","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-15-18-november-2004_en.pdf"},
    {"id":"38645","name":"Pharmaceutics International Inc. Article-31 referral – CHMP list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/428621/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/pharmaceutics-international-inc-article-31-referral-chmp-list-questions_en.pdf"},
    {"id":"38646","name":"Questions and answers on the withdrawal of the marketing authorisation application for Egranli (balugrastim)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2015-02-16T01:00:00Z","reference_number":"EMA/705109/2014","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-egranli-balugrastim_sv.pdf"}},
    {"id":"38649","name":"Ketoprofen (all formulations except topical): List of nationally authorised medicinal products - PSUSA/00001809/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-19T11:57:00Z","last_updated_date":"2018-04-19T11:59:00Z","reference_number":"EMA//210015/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketoprofen-all-formulations-except-topical-list-nationally-authorised-medicinal-products-psusa00001809201707_en.pdf"},
    {"id":"38650","name":"Workshop on draft guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-04-03T02:09:21Z","last_updated_date":"2007-04-03T02:09:21Z","reference_number":"EMEA/213289/2006","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-draft-guideline-requirements-first-man-clinical-trials-potential-high-risk-medicinal-products_en.pdf"},
    {"id":"38657","name":"Presentation - Access to EudraVigilance data to Patients and Health Care professionals (Francois Domergue)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-access-eudravigilance-data-patients-and-health-care-professionals-francois-domergue_en.pdf"},
    {"id":"38658","name":"Work plan for Good Clinical Practice Inspectors Working Group 2014","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2014-02-25T16:50:00Z","last_updated_date":"2014-02-25T16:50:00Z","reference_number":"EMA/INS/GCP/554674/2013","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-good-clinical-practice-inspectors-working-group-2014_en.pdf"},
    {"id":"38660","name":"Draft list of references supporting the assessment of Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-06-16T02:00:00Z","last_updated_date":"2011-06-16T02:00:00Z","reference_number":"EMA/HMPC/143182/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-lavandula-angustifolia-mill-aetheroleum-and-lavandula-angustifolia-mill-flos_en.pdf"},
    {"id":"38661","name":"CHMP-CAT-PRAC member comments on rapporteur’s reports","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-07-03T16:30:00Z","last_updated_date":"2021-07-12T17:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/chmp-cat-prac-member-comments-rapporteurs-reports_en.docx"},
    {"id":"38662","name":"Annual report of the European Medicines Agency 2004","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2005-03-10T00:09:21Z","last_updated_date":"2005-03-10T00:09:21Z","reference_number":"EMEA/61492/2005/EN/Final","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-european-medicines-agency-2004_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/annual-report/annual-report-european-medicines-agency-2004_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/annual-report/annual-report-european-medicines-agency-2004_cs.pdf","da":"https://www.ema.europa.eu/da/documents/annual-report/annual-report-european-medicines-agency-2004_da.pdf","et":"https://www.ema.europa.eu/et/documents/annual-report/annual-report-european-medicines-agency-2004_et.pdf","el":"https://www.ema.europa.eu/el/documents/annual-report/annual-report-european-medicines-agency-2004_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/annual-report/annual-report-european-medicines-agency-2004_fr.pdf","it":"https://www.ema.europa.eu/it/documents/annual-report/annual-report-european-medicines-agency-2004_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/annual-report/annual-report-european-medicines-agency-2004_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/annual-report/annual-report-european-medicines-agency-2004_lt.pdf","mt":"https://www.ema.europa.eu/mt/documents/annual-report/annual-report-european-medicines-agency-2004_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/annual-report/annual-report-european-medicines-agency-2004_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/annual-report/annual-report-european-medicines-agency-2004_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/annual-report/annual-report-european-medicines-agency-2004_pt.pdf","sk":"https://www.ema.europa.eu/sk/documents/annual-report/annual-report-european-medicines-agency-2004_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/annual-report/annual-report-european-medicines-agency-2004_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/annual-report/annual-report-european-medicines-agency-2004_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/annual-report/annual-report-european-medicines-agency-2004_sv.pdf"}},
    {"id":"38664","name":"Outcome of review of new safety data on insulin glargine","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T14:00:00Z","last_updated_date":"2013-05-31T14:00:00Z","reference_number":"EMA/329790/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/outcome-review-new-safety-data-insulin-glargine_en.pdf"},
    {"id":"38665","name":"Presentation - Break-out session 1 regulatory expectations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T17:00:00Z","last_updated_date":"2012-04-30T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-break-out-session-1-regulatory-expectations_en.pdf"},
    {"id":"38668","name":"Public statement on Taluvian (apomorphine hydrochloride) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2004-11-10T01:09:21Z","last_updated_date":"2004-11-10T01:09:21Z","reference_number":"EMEA/88093/04","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-taluvian-apomorphine-hydrochloride-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"38673","name":"Agenda - CAT agenda of the 20-22 June 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-06-22T18:00:00Z","last_updated_date":"2018-06-22T18:00:00Z","reference_number":"EMA/CAT/426129/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-20-22-june-2018-meeting_en.pdf"},
    {"id":"38674","name":"EU/3/04/232: Public summary of positive opinion for orphan designation of biotinylated anti-tenascin monoclonal antibody for use with 90-Yttrium for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-01-04T00:00:00Z","last_updated_date":"2006-01-04T00:00:00Z","reference_number":"EMEA/COMP/122308/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304232-public-summary-positive-opinion-orphan-designation-biotinylated-anti-tenascin-monoclonal-antibody-use-90-yttrium-treatment-glioma_en.pdf"},
    {"id":"38676","name":"Opinion of the CVMP on the establishment of maximum residue limits: Tulathromycin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-02-17T12:40:00Z","last_updated_date":"2015-02-17T12:40:00Z","reference_number":"EMA/CVMP/604655/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-tulathromycin_en.pdf-0"},
    {"id":"38679","name":"Presentation - Pilot of MAH signal detection in EudraVigilance (J. Durand, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-05-03T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pilot-mah-signal-detection-eudravigilance-j-durand-ema_en.pdf"},
    {"id":"38680","name":"EU/3/05/296: Public summary of positive opinion for orphan designation of hydrocortisone (modified release tablet) for the treatment of congenital adrenal hyperplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-21T02:00:00Z","last_updated_date":"2021-06-14T14:06:00Z","reference_number":"EMEA/COMP/216596/2005 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305296-public-summary-positive-opinion-orphan-designation-hydrocortisone-modified-release-tablet-treatment-congenital-adrenal-hyperplasia_en.pdf"},
    {"id":"38682","name":"Divergent position on a CVMP opinion on an Article-13(2) of Commission Regulation (EC) No 1234/2008 Resflor solution injectable","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-09T18:30:00Z","last_updated_date":"2015-01-09T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-132-commission-regulation-ec-no-12342008-resflor-solution-injectable_en.pdf"},
    {"id":"38683","name":"Presentation - Implementation of falsified medicines Directive","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-falsified-medicines-directive_en.pdf"},
    {"id":"38685","name":"Bioenvision Ltd withdraws its application for an extension of indication for Evoltra (clofarabine)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/145939/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/bioenvision-ltd-withdraws-its-application-extension-indication-evoltra-clofarabine_en.pdf"},
    {"id":"38687","name":"Pharmaceutics International Inc. Article-31 referral – Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/428619/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/pharmaceutics-international-inc-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"38689","name":"CHMP summary of positive opinion for Inlyta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/293828/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-inlyta_en.pdf"},
    {"id":"38690","name":"Brief summary of the existing systems on collecting data: The Netherlands","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-03T01:00:00Z","last_updated_date":"2010-02-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/brief-summary-existing-systems-collecting-data-netherlands_en.pdf"},
    {"id":"38691","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Ruscus aculeatus L, rhizome","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2019-05-02T17:00:00Z","reference_number":"EMEA/HMPC/188003/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-ruscus-aculeatus-l-rhizome_en.pdf"},
    {"id":"38694","name":"Tabular overview of updated / new procedural guidance documents in line with the new pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-26T01:00:00Z","last_updated_date":"2013-03-26T01:00:00Z","reference_number":"EMA/199715/2013","document_url":"https://www.ema.europa.eu/en/documents/other/tabular-overview-updated-new-procedural-guidance-documents-line-new-pharmacovigilance-legislation_en.pdf"},
    {"id":"38699","name":"Presentation - Revision of the guideline on conduct of pharmacovigilance for medicines used by the paediatric population (Dirk Mentzer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revision-guideline-conduct-pharmacovigilance-medicines-used-paediatric-population-dirk-mentzer_en.pdf"},
    {"id":"38700","name":"CHMP post-authorisation summary of positive opinion for Ventavis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-03-16T13:00:00Z","last_updated_date":"2012-03-16T13:00:00Z","reference_number":"EMA/CHMP/191421/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ventavis_en.pdf"},
    {"id":"38701","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 15-17 June 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2010-06-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-15-17-june-2010_en.pdf"},
    {"id":"38702","name":"Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-09-19T02:00:00Z","last_updated_date":"2008-09-19T02:00:00Z","reference_number":"EMEA/INS/GCP/468975/2007","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-advice-applicantssponsorscros-bioequivalence-studies_en.pdf"},
    {"id":"38703","name":"Presentation - EMA Workshop Case Study on Analytical Similarity (J.G. Ramirez, Amgen Inc.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-workshop-case-study-analytical-similarity-jg-ramirez-amgen-inc_en.pdf"},
    {"id":"38704","name":"CHMP summary of opinion for Bortezomib Sun","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/170461/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-bortezomib-sun_en.pdf"},
    {"id":"38706","name":"Withdrawal assessment report for Luveniq","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2012-02-03T11:52:00Z","last_updated_date":"2012-02-03T11:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-luveniq_en.pdf"},
    {"id":"38707","name":"EMEA Public Statement on Viramune (nevirapine) - severe and  life threatening cutaneous and hepatic reactions","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2000-04-12T02:00:00Z","last_updated_date":"2000-04-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-viramune-nevirapine-severe-and-life-threatening-cutaneous-and-hepatic-reactions_en.pdf"},
    {"id":"38708","name":"Penethamate (Hydriodide): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1995-01-01T01:00:00Z","last_updated_date":"1995-01-01T01:00:00Z","reference_number":"EMEA/MRL/022-REV2/95","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/penethamate-hydriodide-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38709","name":"Misoprostol (gynaecological indication - labor induction): List of nationally authorised medicinal products - PSUSA/00010353/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-10-18T12:21:19Z","reference_number":"EMA/40935/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gynaecological-indication-labor-induction-list-nationally-authorised-medicinal-products-psusa00010353201505_en.pdf"},
    {"id":"38711","name":"European Union Telematics Management Board - Terms of reference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-08-23T14:55:00Z","last_updated_date":"2018-03-07T18:00:00Z","reference_number":"EMA/88659/2018","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-telematics-management-board-terms-reference_en.pdf"},
    {"id":"38713","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 10-12 April 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-04-22T12:20:00Z","last_updated_date":"2013-04-22T12:20:00Z","reference_number":"EMA/232769/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-10-12-april-2013_en.pdf"},
    {"id":"38714","name":"Cetostearyl alcohol: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-06-01T02:00:00Z","last_updated_date":"1998-06-01T02:00:00Z","reference_number":"EMEA/MRL/448/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cetostearyl-alcohol-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38716","name":"Scientific recommendation on classification of advanced therapy medicinal products: human amniotic membrane mesenchymal stem cells as a sheet","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-04-12T13:00:00Z","last_updated_date":"2016-04-12T13:00:00Z","reference_number":"EMA/241006/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-amniotic-membrane-mesenchymal-stem-cells-sheet_en.pdf"},
    {"id":"38718","name":"Agenda - EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2011-02-22T01:00:00Z","last_updated_date":"2011-02-22T01:00:00Z","reference_number":"EMA/45985/2011","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting_en.pdf"},
    {"id":"38720","name":"EU/3/18/2006: Public summary of opinion on orphan designation: Tazemetostat for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-05-17T02:00:00Z","last_updated_date":"2018-05-17T02:00:00Z","reference_number":"EMA/112323/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182006-public-summary-opinion-orphan-designation-tazemetostat-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"38721","name":"Summary information on referral opinion following arbitration pursuant to Article 30 of Council Directive 2001/83/EC for Floxyfral and associated names International Non-Proprietary Name (INN): fluvoxamine: Background in...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2002-07-25T02:08:21Z","last_updated_date":"2002-07-25T02:08:21Z","reference_number":"EMEA/CPMP/600/02/en/Final","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursuant-article-30-council-directive-200183ec-floxyfral-and-associated-names-international-non-proprietary-name-inn-fluvoxamine-background_en.pdf"},
    {"id":"38723","name":"EU/3/14/1295: Public summary of opinion on orphan designation: Marizomib for the treatment of plasma cell myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-01T02:00:00Z","last_updated_date":"2015-03-26T01:00:00Z","reference_number":"EMA/COMP/360650/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141295-public-summary-opinion-orphan-designation-marizomib-treatment-plasma-cell-myeloma_en.pdf"},
    {"id":"38724","name":"Tetrazepam-containing medicines - Article-107i procedure - Rationale for triggering","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-14T16:00:00Z","last_updated_date":"2013-01-14T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-rationale-triggering_en.pdf"},
    {"id":"38725","name":"Committee for Medicinal Products for Veterinary Use (CVMP): Meeting of 7-9 December 2010","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2010-12-10T01:00:00Z","reference_number":"EMA/CVMP/760118/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-7-9-december-2010_en.pdf"},
    {"id":"38727","name":"Ketotifen (oral formulations): List of nationally authorised medicinal products - PSUSA/00001813/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-22T17:00:00Z","last_updated_date":"2018-06-22T17:00:00Z","reference_number":"EMA/418646/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketotifen-oral-formulations-list-nationally-authorised-medicinal-products-psusa00001813201710_en.pdf"},
    {"id":"38729","name":"Analysis and assessment of the Executive Director's annual activity report 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-06-18T19:00:00Z","last_updated_date":"2013-06-18T19:00:00Z","reference_number":"EMA/MB/302752/2013","document_url":"https://www.ema.europa.eu/en/documents/other/analysis-and-assessment-executive-directors-annual-activity-report-2012_en.pdf"},
    {"id":"38731","name":"Timolol (systemic use) : List of nationally authorised medicinal products - PSUSA/00010432/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-13T13:17:00Z","last_updated_date":"2017-06-13T13:20:00Z","reference_number":"EMA/371481/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/timolol-systemic-use-list-nationally-authorised-medicinal-products-psusa00010432201610_en.pdf"},
    {"id":"38732","name":"Cefuroximaxetil - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2007-09-24T02:08:21Z","last_updated_date":"2007-09-24T02:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_hu.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/cefuroximaxetil-article-29-referral-annex-i-ii-iii_fi.pdf"}},
    {"id":"38733","name":"Presentation - Guidance to pharmaceutical industry on redacting commercially confidential information (CCI) in clinical reports (Anne-Sophie Henry-Eude)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-29T02:00:00Z","last_updated_date":"2015-06-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-pharmaceutical-industry-redacting-commercially-confidential-information-cci-clinical-reports-anne-sophie-henry-eude_en.pdf"},
    {"id":"38735","name":"Final list of references supporting the assessment of Viscum album L., herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T17:05:00Z","last_updated_date":"2013-08-01T17:05:00Z","reference_number":"EMEA/HMPC/246781/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-viscum-album-l-herba_en.pdf"},
    {"id":"38736","name":"Superseded list of references supporting the assessment report on Curcumae longae rhizoma Curcuma longa L., rhizoma (turmeric root) -  First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2010-02-04T01:00:00Z","last_updated_date":"2010-02-04T01:00:00Z","reference_number":"EMA/HMPC/456910/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-curcumae-longae-rhizoma-curcuma-longa-l-rhizoma-turmeric-root-first-version_en.pdf"},
    {"id":"38737","name":"Agenda – Industry and assessors’ joint training on the explanatory note to GVP Module VII and the Q&A for assessors","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-09-04T19:06:00Z","last_updated_date":"2017-09-21T19:30:00Z","reference_number":"EMA/406983/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-industry-and-assessors-joint-training-explanatory-note-gvp-module-vii-and-qa-assessors_en.pdf"},
    {"id":"38738","name":"Guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-12-02T00:09:21Z","last_updated_date":"2009-12-02T00:09:21Z","reference_number":"EMEA/CHMP/EWP/356954/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigations-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"38740","name":"Presentation - Healthcare Professionals' Working Party (HCPWP): Procedure for election of co-chair (Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T17:00:00Z","last_updated_date":"2013-07-12T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthcare-professionals-working-party-hcpwp-procedure-election-co-chair-juan-garcia-burgos_en.pdf"},
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    {"id":"38743","name":"CHMP post-authorisation summary of positive opinion for Ivemend","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"EMA/CHMP/171802/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ivemend_en.pdf"},
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    {"id":"38746","name":"Opinion following an article 34 referral for Eprinex pour-on and its associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-11T02:00:00Z","last_updated_date":"2014-08-11T02:00:00Z","reference_number":"EMA/249804/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-34-referral-eprinex-pour-and-its-associated-names_en.pdf"},
    {"id":"38750","name":"Standard operating procedure for preparation of an initial European Public Assessment Report (EPAR) for a veterinary medicinal product following positive or negative opinion","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2007-10-01T02:00:00Z","last_updated_date":"2015-06-17T13:15:00Z","reference_number":"SOP/V/4037","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-preparation-initial-european-public-assessment-report-epar-veterinary-medicinal-product-following-positive-or-negative-opinion_en.pdf"},
    {"id":"38752","name":"Securing bee health and honey quality, Etienne Bruneau, COPA-COGECA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/securing-bee-health-and-honey-quality-etienne-bruneau-copa-cogeca_en.pdf"},
    {"id":"38753","name":"European Medicines Agency recommends restricting use of cilostazol-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-03-22T01:00:00Z","last_updated_date":"2013-03-22T01:00:00Z","reference_number":"EMA/98571/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-restricting-use-cilostazol-containing-medicines_en.pdf"},
    {"id":"38759","name":"Assessment report for Zinnat and associated names","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-01-29T01:00:00Z","last_updated_date":"2013-01-29T01:00:00Z","reference_number":"EMA/CHMP/633839/2012","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-zinnat-and-associated-names_en.pdf-0"},
    {"id":"38761","name":"Presentation - Role of OMCLs for control of emergency vaccines (Julie Barà©)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-14T17:20:00Z","last_updated_date":"2017-06-14T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-omcls-control-emergency-vaccines-julie-barac_en.pdf"},
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    {"id":"38764","name":"Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-01-22T13:00:00Z","last_updated_date":"2016-10-17T20:16:35Z","reference_number":"EMA/51902/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/clevidipine-list-nationally-authorised-medicinal-products-psusa00010288201505_en.pdf"},
    {"id":"38767","name":"Presentation - Compassionate use programmes in Europe and role of EMA and member states (C.Bouygues, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-26T02:00:00Z","last_updated_date":"2017-10-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-compassionate-use-programmes-europe-and-role-ema-and-member-states-cbouygues-ema_en.pdf"},
    {"id":"38772","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2015 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-04-01T12:55:00Z","last_updated_date":"2015-04-01T12:55:00Z","reference_number":"EMA/CAT/210624/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-march-2015-meeting_en.pdf"},
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    {"id":"38776","name":"Report from the Workshop European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) test of system data collection by species - experiences","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-04-10T02:00:00Z","last_updated_date":"2015-04-10T02:00:00Z","reference_number":"EMA/128656/2015","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-european-surveillance-veterinary-antimicrobial-consumption-esvac-test-system-data-collection-species-experiences_en.pdf"},
    {"id":"38779","name":"Minutes of the European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, 25 October 2017","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2017-12-18T13:40:00Z","last_updated_date":"2017-12-18T13:40:00Z","reference_number":"EMA/743801/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting-25-october-2017_en.pdf"},
    {"id":"38782","name":"CHMP summary of opinion for Nordimet","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T02:00:00Z","last_updated_date":"2016-06-24T02:00:00Z","reference_number":"EMA/CHMP/403945/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-nordimet_en.pdf"},
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    {"id":"38792","name":"Superseded - Assessment report on Aloe barabadensis Miller and Aloe (various species, mainly Aloe ferox Miller and its hybrids)","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMEA/HMPC/76313/2006","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-aloe-barabadensis-miller-and-aloe-various-species-mainly-aloe-ferox-miller-and-its-hybrids_en.pdf"},
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    {"id":"38832","name":"Erdosteine: List of nationally authorised medicinal products - PSUSA/00001248/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-09-30T02:00:00Z","last_updated_date":"2016-10-18T13:42:41Z","reference_number":"EMA/648919/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/erdosteine-list-nationally-authorised-medicinal-products-psusa00001248201602_en.pdf"},
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    {"id":"38837","name":"Superseded overview of comments received on 'Community herbal monograph on Mentha x piperita L., folium' (EMEA/HMPC/193909/2007)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2008-09-04T02:00:00Z","last_updated_date":"2008-09-04T02:00:00Z","reference_number":"EMEA/HMPC/101815/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-mentha-x-piperita-l-folium-emeahmpc1939092007_en.pdf"},
    {"id":"38838","name":"Programme - Workshop on the role of pharmacokinetic and pharmacodynamic measurements in the use of direct oral anticoagulants","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-10-16T13:18:00Z","last_updated_date":"2015-11-17T16:10:00Z","reference_number":"EMA/681537/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-workshop-role-pharmacokinetic-and-pharmacodynamic-measurements-use-direct-oral-anticoagulants_en.pdf"},
    {"id":"38839","name":"CHMP summary of positive opinion for Abilify Maintena","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/489804/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-abilify-maintena_en.pdf"},
    {"id":"38841","name":"Draft community herbal monograph on Rosmarinus officinalis L., aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2009-07-16T02:00:00Z","reference_number":"EMEA/HMPC/235453/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-rosmarinus-officinalis-l-aetheroleum_en.pdf"},
    {"id":"38843","name":"CHMP post-authorisation summary of positive opinion for Docetaxel Winthrop","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2022-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-docetaxel-winthrop_en.pdf-0"},
    {"id":"38844","name":"Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 22-25 February 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-03-04T15:00:00Z","last_updated_date":"2016-03-04T15:00:00Z","reference_number":"EMA/76584/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-22-25-february-2016_en.pdf"},
    {"id":"38846","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting 12-15 November 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-22T10:15:00Z","last_updated_date":"2012-11-22T10:15:00Z","reference_number":"EMA/CHMP/732278/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-12-15-november-2012_en.pdf"},
    {"id":"38847","name":"The EU Risk Management Plan: Does A Common Standard Exist? - BDC Arnold","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-risk-management-plan-does-common-standard-exist-bdc-arnold_en.pdf"},
    {"id":"38849","name":"Overview of comments received on 'Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medici...","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2016-03-07T12:00:00Z","reference_number":"EMA/647097/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-scientific-application-and-practical-arrangements-necessary-implement-commission-regulation-ec-no-5072006-conditional-marketing-authorisation-medici_en.pdf"},
    {"id":"38852","name":"Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 January 2012","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-01-13T17:00:00Z","last_updated_date":"2012-01-13T17:00:00Z","reference_number":"EMA/CVMP/5471/2012 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-10-12-january-2012_en.pdf"},
    {"id":"38853","name":"Overview of comments received on draft guideline on the conduct of pharmacovigilance for vaccines for pre- and post-exposure prophylaxis against infectious diseases (EMEA/CHMP/PHVWP/503449/2007)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-07-22T02:09:21Z","last_updated_date":"2009-07-22T02:09:21Z","reference_number":"EMEA/CHMP/PhVWP/36043/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-draft-guideline-conduct-pharmacovigilance-vaccines-pre-and-post-exposure-prophylaxis-against-infectious-diseases-emeachmpphvwp5034492007_en.pdf"},
    {"id":"38854","name":"Tolterodine : List of nationally authorised medicinal products - PSUSA/00002993/201609","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-05-10T19:01:00Z","last_updated_date":"2017-05-10T19:02:42Z","reference_number":"EMA/290528/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/tolterodine-list-nationally-authorised-medicinal-products-psusa00002993201609_en.pdf"},
    {"id":"38857","name":"Presentation - CVMP work plan for 2015: Highlights and potential implications for new applications and developments (Anja Holm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-work-plan-2015-highlights-and-potential-implications-new-applications-and-developments-anja-holm_en.pdf"},
    {"id":"38859","name":"Meeting highlights from the Committee for Medicinal Products for Human Use,\n\n18-21 June 2007","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-06-22T02:09:21Z","last_updated_date":"2007-06-22T02:09:21Z","reference_number":"EMEA/267556/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-committee-medicinal-products-human-use-18-21-june-2007_en.pdf"},
    {"id":"38862","name":"European Medicines Agency releases for public consultation its draft policy on the publication and access to clinical-trial data","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-06-24T16:00:00Z","last_updated_date":"2013-06-24T16:00:00Z","reference_number":"EMA/382397/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-releases-public-consultation-its-draft-policy-publication-and-access-clinical-trial-data_en.pdf"},
    {"id":"38863","name":"Conditional Marketing Authorisation - Francesco Pignatti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-02-05T00:09:21Z","last_updated_date":"2007-02-05T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/conditional-marketing-authorisation-francesco-pignatti_en.pdf"},
    {"id":"38864","name":"EU/3/12/1086: Public summary of opinion on orphan designation: Eflornithine in combination with sulindac for the treatment of familial adenomatous polyposis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-03-01T01:00:00Z","last_updated_date":"2013-03-01T01:00:00Z","reference_number":"EMA/COMP/798800/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121086-public-summary-opinion-orphan-designation-eflornithine-combination-sulindac-treatment-familial-adenomatous-polyposis_en.pdf"},
    {"id":"38867","name":"Implementation of the action plan to further progress the european risk management strategy: rolling two-year work programme (2008-2009)","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T00:00:00Z","last_updated_date":"2007-12-04T00:00:00Z","reference_number":"EMEA/280089/2007","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/implementation-action-plan-further-progress-european-risk-management-strategy-rolling-two-year-work-programme-2008-2009_en.pdf"},
    {"id":"38868","name":"Presentation - Update on the revision of the veterinary legislation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-revision-veterinary-legislation_en.pdf"},
    {"id":"38871","name":"EU/3/16/1808: Public summary of opinion on orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/14165/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161808-public-summary-opinion-orphan-designation-6ar-10ar-3-11-dimethylheptyl-delta-8-tetrahydro-cannabinol-9-carboxylic-acid-treatment-systemic-sclerosis_en.pdf"},
    {"id":"38872","name":"Questions and answers on the withdrawal of the marketing authorisation application for Nenad (lisuride)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/830685/2009","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-nenad-lisuride_sv.pdf"}},
    {"id":"38873","name":"Agenda - Global Animal Health Conference","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2007-10-29T00:09:21Z","last_updated_date":"2007-10-29T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-global-animal-health-conference_en.pdf-0"},
    {"id":"38874","name":"CHMP summary of positive opinion for Daklinza","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/CHMP/372924/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-daklinza_en.pdf"},
    {"id":"38875","name":"Presentation - EU IDMP/SPOR Task Force meeting: SPOR for veterinary (2. agenda) (Jos Olaerts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-idmpspor-task-force-meeting-spor-veterinary-2-agenda-jos-olaerts_en.pdf"},
    {"id":"38876","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Tepadina (thiotepa) for the conditioning treatment prior to haematopoietic progenitor cell transplantation","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2011-04-11T02:00:00Z","last_updated_date":"2011-04-11T02:00:00Z","reference_number":"EMA/COMP/430447/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-tepadina-thiotepa-conditioning-treatment-prior-haematopoietic-progenitor-cell-transplantation_en.pdf"},
    {"id":"38879","name":"Amoxil Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-09-14T02:00:00Z","last_updated_date":"2015-09-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/amoxil-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/amoxil-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/amoxil-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/amoxil-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/amoxil-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/amoxil-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/amoxil-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/amoxil-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/amoxil-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/amoxil-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/amoxil-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/amoxil-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/amoxil-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/amoxil-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/amoxil-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/amoxil-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/amoxil-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/amoxil-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/amoxil-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/amoxil-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/amoxil-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/amoxil-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/amoxil-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"38880","name":"VICH GL11: Impurities in new veterinary medicinal products - Revision at step 9 for consultation at step 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-06-15T02:00:00Z","last_updated_date":"2005-06-15T02:00:00Z","reference_number":"CVMP/VICH/838/99-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl11-impurities-new-veterinary-medicinal-products-revision-step-9-consultation-step-4_en.pdf"},
    {"id":"38881","name":"COMP meeting report on the review of applications for orphan designation: March 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-03-14T16:40:00Z","last_updated_date":"2014-03-14T16:40:00Z","reference_number":"EMA/COMP/105712/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-march-2014_en.pdf"},
    {"id":"38882","name":"EU/3/11/907: Public summary of opinion on orphan designation: Kifunensine for the treatment of delta sarcoglycanopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2014-06-19T02:00:00Z","reference_number":"EMA/COMP/657803/2011 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311907-public-summary-opinion-orphan-designation-kifunensine-treatment-delta-sarcoglycanopathy_en.pdf"},
    {"id":"38883","name":"Addendum to assessment report on Polypodium vulgare L., rhizoma","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-08-16T13:00:00Z","last_updated_date":"2018-08-16T13:00:00Z","reference_number":"EMA/HMPC/627591/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-polypodium-vulgare-l-rhizoma_en.pdf"},
    {"id":"38884","name":"Overview of comments received on ‘Guideline on the processing of renewals in the centralised procedure","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-08-04T11:00:00Z","last_updated_date":"2016-08-04T11:00:00Z","reference_number":"EMA/723788/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-processing-renewals-centralised-procedure_en.pdf"},
    {"id":"38885","name":"Concept paper on revision of the note for guidance on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-06-27T02:00:00Z","last_updated_date":"2006-06-27T02:00:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/173698/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-use-near-infrared-spectroscopy-pharmaceutical-industry-and-data-requirements-new-submissions-and-variations_en.pdf"},
    {"id":"38887","name":"Appendix 2 - Pharmacovigilance inspection overview template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-02-02T16:55:00Z","last_updated_date":"2015-02-02T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-2-pharmacovigilance-inspection-overview-template_en.doc"},
    {"id":"38888","name":"European Medicines Agency starts review of Tredaptive, Pelzont and Trevaclyn","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T12:10:00Z","last_updated_date":"2011-12-21T12:10:00Z","reference_number":"EMA/821179/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-starts-review-tredaptive-pelzont-and-trevaclyn_en.pdf"},
    {"id":"38890","name":"Annexes to the annual report of the European Medicines Agency 2014","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2015-04-30T12:00:00Z","last_updated_date":"2015-04-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annexes-annual-report-european-medicines-agency-2014_en.pdf"},
    {"id":"38892","name":"EU/3/05/317: Public summary of positive opinion for orphan designation of a mixture of anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein and anti-CD7 mAb (WT1)-ricin A chain fusion protein for the treatment of graft-ve...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-10-27T02:00:00Z","last_updated_date":"2013-03-19T13:30:00Z","reference_number":"EMA/COMP/241073/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305317-public-summary-positive-opinion-orphan-designation-mixture-anti-cd3-mab-spv-t3a-ricin-chain-fusion-protein-and-anti-cd7-mab-wt1-ricin-chain-fusion-protein-treatment-graft-ve_en.pdf"},
    {"id":"38893","name":"Programme - European Medicines Agency workshop on the investigation of subgroups in confirmatory clinical trials","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-11-07T01:00:00Z","last_updated_date":"2014-11-07T01:00:00Z","reference_number":"EMA/257665/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-european-medicines-agency-workshop-investigation-subgroups-confirmatory-clinical-trials_en.pdf"},
    {"id":"38894","name":"EU/3/12/1049: Public summary of opinion on orphan designation: Rucaparib for the treatment of ovarian cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2019-02-19T01:00:00Z","reference_number":"EMA/COMP/613865/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121049-public-summary-opinion-orphan-designation-rucaparib-treatment-ovarian-cancer_en.pdf"},
    {"id":"38899","name":"Appendix 1 to the guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98 REV. 1) on imaging agents","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-07-23T02:00:00Z","last_updated_date":"2009-07-23T02:00:00Z","reference_number":"EMEA/CHMP/EWP/321180/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/appendix-1-guideline-clinical-evaluation-diagnostic-agents-cpmpewp111998-rev-1-imaging-agents_en.pdf"},
    {"id":"38902","name":"Agenda - European network of paediatric research at the European Medicines Agency Coordinating Group members meeting - 21 October 2015","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-10-20T18:40:00Z","last_updated_date":"2015-10-20T18:40:00Z","reference_number":"EMA/554410/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-network-paediatric-research-european-medicines-agency-coordinating-group-members-meeting-21-october-2015_en.pdf"},
    {"id":"38904","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2004-12-31T01:00:00Z","last_updated_date":"2004-12-31T01:00:00Z","reference_number":"CPMP/ICH/5716/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-topic-e-2-e-pharmacovigilance-planning-step-5_en.pdf"},
    {"id":"38905","name":"Workshop report - Joint European Medicines Agency / European Directorate for the Quality of Medicines and Healthcare workshop on characterisation of new clotting-factor concentrates (factor VIII and factor IX) with respe...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-07-11T14:30:00Z","last_updated_date":"2014-07-11T14:30:00Z","reference_number":"EMA/135928/2014","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-joint-european-medicines-agency-european-directorate-quality-medicines-and-healthcare-workshop-characterisation-new-clotting-factor-concentrates-factor-viii-and-factor-ix-respe_en.pdf"},
    {"id":"38906","name":"Terms of reference of the Management Board Telematics Committee","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T11:30:00Z","last_updated_date":"2011-12-20T11:30:00Z","reference_number":"EMA/907384/2011","document_url":"https://www.ema.europa.eu/en/documents/other/terms-reference-management-board-telematics-committee_en.pdf-0"},
    {"id":"38913","name":"Presentation - Overview of key principles of the EU good practice guide (GPG) on medication errors (Thomas Goedecke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-01T01:00:00Z","last_updated_date":"2017-03-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-key-principles-eu-good-practice-guide-gpg-medication-errors-thomas-goedecke_en.pdf"},
    {"id":"38914","name":"Questions to panel on qualification of the PBPK platform for the intended purpose","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T15:35:00Z","last_updated_date":"2016-12-05T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/questions-panel-qualification-pbpk-platform-intended-purpose_en.pdf"},
    {"id":"38916","name":"Withdrawal letter: Simponi","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-simponi_en.pdf"},
    {"id":"38919","name":"Octenidine dihydrochloride / phenoxyethanol: List of nationally authorised medicinal products - PSUSA/00002199/201701","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-24T13:30:00Z","last_updated_date":"2017-10-24T13:30:00Z","reference_number":"EMA/706786/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/octenidine-dihydrochloride-phenoxyethanol-list-nationally-authorised-medicinal-products-psusa00002199201701_en.pdf"},
    {"id":"38923","name":"Mutual recognition agreements: Sectoral Annex on Good Manufacturing Practices - Internationally Harmonised Requirements for Batch Certification","type":"other","status":"unknown","consultation_date":"","first_published_date":"2004-05-01T02:00:00Z","last_updated_date":"2004-05-01T02:00:00Z","reference_number":"EMEA/MRA/23/01 Rev 4","document_url":"https://www.ema.europa.eu/en/documents/other/mutual-recognition-agreements-sectoral-annex-good-manufacturing-practices-internationally-harmonised-requirements-batch-certification_en.doc"},
    {"id":"38927","name":"Azaperone: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T01:00:00Z","last_updated_date":"1997-11-01T01:00:00Z","reference_number":"EMEA/MRL/300/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/azaperone-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"38928","name":"Presentation - Update on post-authorisation efficacy studies (Kevin Blake, Jane Moseley, Christelle Bouygues)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-09-22T13:00:00Z","last_updated_date":"2014-09-22T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-post-authorisation-efficacy-studies-kevin-blake-jane-moseley-christelle-bouygues_en.pdf"},
    {"id":"38929","name":"Opinion of the Committee on Herbal Medicinal Products on a Community herbal monograph on Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-05-18T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMA/HMPC/757063/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"38933","name":"Declaration of interests: Ana Rodriguez Sanchez Beato","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-02-29T10:06:00Z","last_updated_date":"2019-10-25T10:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-ana-rodriguez-sanchez-beato_en.pdf"},
    {"id":"38934","name":"Committee for medicinal products for veterinary use summary of opinion: Improvac: Gonadotropin releasing factor (GNRF) analogue-protein conjugate","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-03-13T01:09:21Z","last_updated_date":"2009-03-13T01:09:21Z","reference_number":"EMEA/CVMP/18480/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-veterinary-use-summary-opinion-improvac-gonadotropin-releasing-factor-gnrf-analogue-protein-conjugate_en.pdf"},
    {"id":"38935","name":"Dexamed and associated names Article-29(4) referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-09-02T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/dexamed-and-associated-names-article-294-referral-annex-iii_no.pdf"}},
    {"id":"38937","name":"EU/3/16/1758: Public summary of positive opinion for orphan designation of p-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-15T01:00:00Z","last_updated_date":"2016-11-15T01:00:00Z","reference_number":"EMA/629732/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161758-public-summary-positive-opinion-orphan-designation-p-ethoxy-growth-factor-receptor-bound-protein-2-antisense-oligonucleotide-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"38938","name":"Presentation - Optimising resources","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-02T12:00:00Z","last_updated_date":"2012-02-02T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optimising-resources_en.pdf"},
    {"id":"38939","name":"Superseded Community herbal monograph on Cassia senna L. and Cassia angustifolia Vahl, folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2006-10-26T02:09:00Z","last_updated_date":"2006-10-26T02:09:00Z","reference_number":"EMEA/HMPC/51869/2006 Corrigendum","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-cassia-senna-l-and-cassia-angustifolia-vahl-folium_en.pdf"},
    {"id":"38941","name":"Public summary of the evaluation of the proposed product-specific waiver: Human recombinant follicle-stimulating hormone (FE 999049) for treatment of female infertility and treatment of hypogonadotrophic hypogonadism","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T12:00:00Z","last_updated_date":"2014-10-21T12:00:00Z","reference_number":"EMA/503612/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-human-recombinant-follicle-stimulating-hormone-fe-999049-treatment-female-infertility-and-treatment-hypogonadotrophic-hypogonadism_en.pdf"},
    {"id":"38943","name":"Presentation - ICH E6 Addendum on Good Clinical Practice (Fergus Sweeney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-23T02:00:00Z","last_updated_date":"2016-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-e6-addendum-good-clinical-practice-fergus-sweeney_en.pdf"},
    {"id":"38945","name":"EU/3/04/255: Public summary of positive opinion for orphan designation of sabarubicin for the treatment of small cell lung cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/157131/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304255-public-summary-positive-opinion-orphan-designation-sabarubicin-treatment-small-cell-lung-cancer_en.pdf"},
    {"id":"38946","name":"CVMP summary of positive opinion for Ratiogratim","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-07-25T02:00:00Z","last_updated_date":"2008-07-25T02:00:00Z","reference_number":"EMEA/CHMP/374682/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-ratiogratim_en.pdf"},
    {"id":"38948","name":"EU/3/15/1554: Public summary of opinion on orphan designation: Nimodipine for the treatment of aneurysmal subarachnoid haemorrhage","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-11-16T01:00:00Z","last_updated_date":"2015-11-16T01:00:00Z","reference_number":"EMA/COMP/602415/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151554-public-summary-opinion-orphan-designation-nimodipine-treatment-aneurysmal-subarachnoid-haemorrhage_en.pdf"},
    {"id":"38950","name":"Report on ‘Action plan for herbal medicines 2010-2011’","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-13T18:15:00Z","last_updated_date":"2012-06-13T18:15:00Z","reference_number":"EMA/HMPC/45679/2012","document_url":"https://www.ema.europa.eu/en/documents/report/report-action-plan-herbal-medicines-2010-2011_en.pdf"},
    {"id":"38955","name":"European Medicines Agency: Committee for Medicinal Products for Human Use, 22-23 June 2004","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-06-24T02:09:21Z","last_updated_date":"2004-06-24T02:09:21Z","reference_number":"EMEA/17587/04/Final","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-22-23-june-2004_en.pdf"},
    {"id":"38957","name":"CHMP post-authorisation summary of positive opinion for Yervoy","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/547838/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yervoy_en.pdf"},
    {"id":"38958","name":"Zidovudine : List of nationally authorised medicinal products - PSUSA/00003143/201703","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-04T16:48:00Z","last_updated_date":"2017-12-04T16:57:46Z","reference_number":"EMA/787818/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/zidovudine-list-nationally-authorised-medicinal-products-psusa00003143201703_en.pdf"},
    {"id":"38960","name":"Presentation - ACTR (Antibody Coupled T-cell Receptor): A universal approach to T-cell therapy (Michael Vasconcelles)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-actr-antibody-coupled-t-cell-receptor-universal-approach-t-cell-therapy-michael-vasconcelles_en.pdf"},
    {"id":"38961","name":"Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2005-09-15T02:00:00Z","last_updated_date":"2005-09-15T02:00:00Z","reference_number":"EMEA/CHMP/EWP/561/98 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-multiple-sclerosis-revision-1_en.pdf"},
    {"id":"38963","name":"CVMP summary of positive opinion for Porcilis PCV M Hyo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-09-12T02:00:00Z","last_updated_date":"2014-09-12T02:00:00Z","reference_number":"EMA/CVMP/450050/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-porcilis-pcv-m-hyo_en.pdf"},
    {"id":"38964","name":"EU/3/12/1047: Public summary of opinion on orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro for the treatment of acute lung injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-11-16T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"EMA/COMP/629946/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3121047-public-summary-opinion-orphan-designation-asp-arg-val-tyr-ile-his-pro-treatment-acute-lung-injury_en.pdf"},
    {"id":"38965","name":"Ethinylestradiol / norethisterone: List of nationally authorised medicinal products - PSUSA/00001312/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-16T12:23:00Z","last_updated_date":"2018-04-16T12:24:38Z","reference_number":"EMA/235814/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethinylestradiol-norethisterone-list-nationally-authorised-medicinal-products-psusa00001312201708_en.pdf"},
    {"id":"38967","name":"European Medicines Agency consulting on a draft guideline on pharmacovigilance for medicines used in children","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2005-08-12T02:00:00Z","last_updated_date":"2005-08-12T02:00:00Z","reference_number":"EMEA/262135/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-consulting-draft-guideline-pharmacovigilance-medicines-used-children_en.pdf"},
    {"id":"38970","name":"Questions and answers on the withdrawal of the marketing authorisation application for Mulsevo (semuloparin sodium)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T02:00:00Z","last_updated_date":"2012-07-20T02:00:00Z","reference_number":"EMA/453098/2012","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-mulsevo-semuloparin-sodium_en.pdf"},
    {"id":"38972","name":"Presentation - Micro-, small- and medium-sized-enterprise (SME) Policy : DG Internal market (Krista De Spiegeleer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-micro-small-and-medium-sized-enterprise-sme-policy-dg-internal-market-krista-de-spiegeleer_en.pdf"},
    {"id":"38973","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Avena sativa L., fructus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/304988/2008EN","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-avena-sativa-l-fructus_en.pdf"},
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    {"id":"38996","name":"First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/496941/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-medicine-hiv-pre-exposure-prophylaxis-recommended-approval-eu_en.pdf"},
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    {"id":"39065","name":"EU/3/10/808: Public summary of opinion on orphan designation Murine monoclonal antibody against CD26 for the treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-15T01:00:00Z","last_updated_date":"2014-01-22T01:00:00Z","reference_number":"EMA/COMP/604454/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310808-public-summary-opinion-orphan-designation-murine-monoclonal-antibody-against-cd26-treatment-graft-versus-host-disease_en.pdf"},
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    {"id":"39069","name":"Metformin Article-31 referral - Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"EMA/603690/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/metformin-article-31-referral-use-metformin-treat-diabetes-now-expanded-patients-moderately-reduced-kidney-function_no.pdf"}},
    {"id":"39071","name":"European Medicines Agency’s Management Board emphasises the importance of the European medicines network","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-03-26T01:00:00Z","last_updated_date":"2010-03-26T01:00:00Z","reference_number":"EMA/169371/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-emphasises-importance-european-medicines-network_en.pdf"},
    {"id":"39072","name":"European Medicines Agency agrees to recall of Vimpat 15-mg/ml syrup","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2011-07-22T02:00:00Z","reference_number":"EMA/CHMP/581202/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-agrees-recall-vimpat-15-mgml-syrup_en.pdf"},
    {"id":"39073","name":"Matricariae flos: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T01:00:00Z","last_updated_date":"1997-11-01T01:00:00Z","reference_number":"EMEA/MRL/280/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/matricariae-flos-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39074","name":"Agenda - CAT agenda of the 12-14 July 2017 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-07-14T15:25:00Z","last_updated_date":"2017-07-14T15:25:00Z","reference_number":"EMA/CAT/451773/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-12-14-july-2017-meeting_en.pdf"},
    {"id":"39075","name":"Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Monepantel","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-11-16T14:24:00Z","last_updated_date":"2016-11-16T14:24:00Z","reference_number":"EMA/CVMP/322539/2016","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits-monepantel_en.pdf"},
    {"id":"39076","name":"CHMP post-authorisation summary of positive opinion for Simponi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-07-26T14:00:00Z","last_updated_date":"2013-07-26T14:00:00Z","reference_number":"EMA/CHMP/365481/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-simponi_en.pdf-3"},
    {"id":"39077","name":"Presentation - Overview of CVMP activities on antimicrobial resistance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-cvmp-activities-antimicrobial-resistance_en.pdf"},
    {"id":"39078","name":"Extract from the Communication Paper of the Gene Therapy Discussion Group Meeting (GTDG)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-02-02T00:09:21Z","last_updated_date":"2008-02-02T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/extract-communication-paper-gene-therapy-discussion-group-meeting-gtdg_en.pdf"},
    {"id":"39080","name":"Presentation - Revised framework of interaction with HCPs (Ivana Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revised-framework-interaction-hcps-ivana-silva-ema_en.pdf"},
    {"id":"39083","name":"EU/3/14/1263: Public summary of opinion on orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for the treatment of sickle cell dise...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-06-04T02:00:00Z","last_updated_date":"2021-12-07T01:00:00Z","reference_number":"EMA/COMP/172803/2014 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141263-public-summary-opinion-orphan-designation-autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-encoding-human-beta-t87q-globin-gene-treatment-sickle-cell-dise_en.pdf"},
    {"id":"39084","name":"Summary information on a referral opinion following an arbitration pursant to Article 29 of Directive 2001/83/EC, for Isotretinoin, Lurantal, Trivane, Rexidal, Rcheritonin (See Annex I) International Non-Proprietary Name...","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2003-10-17T02:08:21Z","last_updated_date":"2003-10-17T02:08:21Z","reference_number":"CPMP/2811/03","document_url":"https://www.ema.europa.eu/en/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/summary-information-referral-opinion-following-arbitration-pursant-article-29-directive-200183ec-isotretinoin-lurantal-trivane-rexidal-rcheritonin-see-annex-i-international-non-proprietary-name_sv.pdf"}},
    {"id":"39087","name":"CHMP summary of positive opinion Entresto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/CHMP/616915/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-entresto_en.pdf"},
    {"id":"39088","name":"Celvapan: Product information as recommended by the CHMP on 22 April 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2010-04-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/celvapan-product-information-recommended-chmp-22-april-2010_en.pdf"},
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    {"id":"39204","name":"EU/3/06/429: Public summary of positive opinion for orphan designation of recombinant modified vaccinia Ankara expressing human 5T4  for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T00:00:00Z","last_updated_date":"2007-12-04T00:00:00Z","reference_number":"EMEA/COMP/495766/2006","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306429-public-summary-positive-opinion-orphan-designation-recombinant-modified-vaccinia-ankara-expressing-human-5t4-treatment-renal-cell-carcinoma_en.pdf"},
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    {"id":"39214","name":"EudraVigilance XCOMP release - EudraVigilance web application (EVWEB) version 3.0","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2017-11-22T10:30:00Z","reference_number":"EMA/629617/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-xcomp-release-eudravigilance-web-application-evweb-version-30_en.pdf"},
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    {"id":"39219","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (Germany, Hungary, Latvia)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-germany-hungary-latvia_en.pdf"},
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    {"id":"39223","name":"EU/3/03/146: Public summary of positive opinion for orphan designation of aldesleukin (inhalation use) for the treatment of renal cell carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-23T01:00:00Z","last_updated_date":"2007-02-23T01:00:00Z","reference_number":"EMEA/COMP/1228/03 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu303146-public-summary-positive-opinion-orphan-designation-aldesleukin-inhalation-use-treatment-renal-cell-carcinoma_en.pdf"},
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    {"id":"39260","name":"Call for submission of scientific data relating to the assessment of  Leonuri cardiacae herba Leonurus cardiaca l., herba (Motherwort herb)","type":"herbal-call-data","status":"unknown","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/HMPC/657306/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-relating-assessment-leonuri-cardiacae-herba-leonurus-cardiaca-l-herba-motherwort-herb_en.pdf"},
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    {"id":"39282","name":"PDCO meeting highlights 14-16 July 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/PDCO/451774/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-14-16-july-2010_en.pdf"},
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    {"id":"39287","name":"EU/3/07/503: Public summary of positive opinion for orphan designation of recombinant human hepatitis C monoclonal antibody against C4 region of E1 for the prevention of recurrent hepatitis C virus induced liver disease ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2008-08-18T02:00:00Z","reference_number":"EMEA/COMP/135814/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307503-public-summary-positive-opinion-orphan-designation-recombinant-human-hepatitis-c-monoclonal-antibody-against-c4-region-e1-prevention-recurrent-hepatitis-c-virus-induced-liver-disease_en.pdf"},
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    {"id":"39293","name":"EU/3/04/188: Public summary of positive opinion for orphan designation of N-3[[4(aminoiminomethyl)benzoyl]amino]propyl]-1-[[2,4-dichloro-3-[[2,4-dimethyl-8-quinolinyl)oxy]methyl] phenyl]sulphonyl]-(2S)-2-pyrrolidinecarbo...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-02-23T00:00:00Z","last_updated_date":"2007-02-23T00:00:00Z","reference_number":"EMEA/COMP/30/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304188-public-summary-positive-opinion-orphan-designation-n-34aminoiminomethylbenzoylaminopropyl-1-24-dichloro-3-24-dimethyl-8-quinolinyloxymethyl-phenylsulphonyl-2s-2-pyrrolidinecarbo_en.pdf"},
    {"id":"39295","name":"Guidelines and concept papers adopted during the CHMP meeting 19-22 May 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/124022/2014","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-19-22-may-2014_en.pdf-0"},
    {"id":"39298","name":"CHMP summary of positive opinion for Ravicti","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/628694/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ravicti_en.pdf"},
    {"id":"39299","name":"Draft guideline on the development of medicinal products for the treatment of post-traumatic stress disorder (PTSD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2007-09-20T02:00:00Z","reference_number":"CHMP/EWP/358650/06","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-medicinal-products-treatment-post-traumatic-stress-disorder-ptsd_en.pdf"},
    {"id":"39302","name":"CHMP summary of positive opinion for Tresiba","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-10-19T14:30:00Z","last_updated_date":"2012-10-19T14:30:00Z","reference_number":"EMA/CHMP/582803/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tresiba_en.pdf"},
    {"id":"39303","name":"Presentation - EMA/EGA workshop - Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (Beata Stepniewska)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-05-04T02:00:00Z","last_updated_date":"2015-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaega-workshop-guideline-pharmacokinetic-and-clinical-evaluation-modified-release-dosage-forms-beata-stepniewska_en.pdf"},
    {"id":"39305","name":"Guideline on the clinical investigation of human Anti-D immunoglobulin for intravenous and/or intramuscular use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-09-20T02:00:00Z","last_updated_date":"2007-09-20T02:00:00Z","reference_number":"CPMP/BPWG/575/99 Rev. 1 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-human-anti-d-immunoglobulin-intravenous-andor-intramuscular-use_en.pdf"},
    {"id":"39306","name":"Annex I - Privacy statement for bank account validation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-01T02:00:00Z","last_updated_date":"2009-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-i-privacy-statement-bank-account-validation_en.pdf"},
    {"id":"39308","name":"Draft list of references supporting the assessment of Echinaceae angustifolia DC., radix","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2011-07-28T02:00:00Z","last_updated_date":"2011-07-28T02:00:00Z","reference_number":"EMA/HMPC/688215/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-echinaceae-angustifolia-dc-radix_en.pdf"},
    {"id":"39310","name":"CHMP summary of positive opinion for Efavirenz/Emtricitabine/Tenofovir disoproxil Krka","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/CHMP/812280/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-efavirenzemtricitabinetenofovir-disoproxil-krka_en.pdf"},
    {"id":"39311","name":"Concept paper on the development of a guideline on the use of pharmacogenomic methodologies in the pharmacokinetic evaluation of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/CHMP/PGxWP/63270/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-use-pharmacogenomic-methodologies-pharmacokinetic-evaluation-medicinal-products_en.pdf"},
    {"id":"39315","name":"HMPC meeting report on Community herbal monographs, guidelines and other activities - 6-7 July 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-07-22T17:18:00Z","last_updated_date":"2015-07-22T17:18:00Z","reference_number":"EMA/HMPC/473270/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-community-herbal-monographs-guidelines-and-other-activities-6-7-july-2015_en.pdf"},
    {"id":"39317","name":"Biographies of chairs, speakers and panellists","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-03T02:09:21Z","last_updated_date":"2007-10-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/biographies-chairs-speakers-and-panellists_en.pdf"},
    {"id":"39319","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2014","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2014-12-17T16:15:15Z","last_updated_date":"2014-12-17T16:15:15Z","reference_number":"EMA/699369/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-november-2014_en.pdf"},
    {"id":"39321","name":"Clinical trials submitted in marketing-authorisation applications to the European Medicines Agency: Overview of patient recruitment and the geographical location of investigator sites","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-09-23T02:09:21Z","last_updated_date":"2013-04-09T18:50:00Z","reference_number":"EMA/INS/GCP/676319/2012","document_url":"https://www.ema.europa.eu/en/documents/other/clinical-trials-submitted-marketing-authorisation-applications-european-medicines-agency-overview-patient-recruitment-and-geographical-location-investigator-sites_en.pdf"},
    {"id":"39326","name":"CHMP post-authorisation summary of positive opinion for Abraxane","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/627632/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abraxane_en.pdf-0"},
    {"id":"39327","name":"Presentation - Pharmacovigilance system - Regulatory tools: report on lack of efficacy (P. Ekstrom)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-system-regulatory-tools-report-lack-efficacy-p-ekstrom_en.pdf"},
    {"id":"39328","name":"Overview of comments received on draft guideline on the assessment of genotoxic constituents in herbal substances/ preparations (EMEA/HMPC/107079/2007)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-05-21T02:00:00Z","last_updated_date":"2008-05-21T02:00:00Z","reference_number":"EMEA/HMPC/232888/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-assessment-genotoxic-constituents-herbal-substances-preparations-emeahmpc1070792007_en.pdf"},
    {"id":"39329","name":"Substances related to nicotinic acid Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-10-11T19:00:00Z","reference_number":"EMA/PRAC/138312/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/substances-related-nicotinic-acid-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"39330","name":"EU/3/16/1754: Public summary of positive opinion for orphan designation of lutetium-177(3+), S2,S7-cyclo[N-{4,7,10-tricarboxymethyl-1,4,7,10-tetraaza-cyclododecan-1-yl-acetyl}-4-chloro-L-phenylalanyl-D-cysteinyl-4-[(4S)-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/615260/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161754-public-summary-positive-opinion-orphan-designation-lutetium-1773-s2s7-cyclon-4710-tricarboxymethyl-14710-tetraaza-cyclododecan-1-yl-acetyl-4-chloro-l-phenylalanyl-d-cysteinyl-4-4s_en.pdf"},
    {"id":"39331","name":"Committee on Herbal Medicinal Products and Working Party on Community Monographs and Community List meeting dates in 2011","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-04-07T02:00:00Z","last_updated_date":"2011-04-19T02:00:00Z","reference_number":"EMA/203076/2010","document_url":"https://www.ema.europa.eu/en/documents/other/committee-herbal-medicinal-products-and-working-party-community-monographs-and-community-list-meeting-dates-2011_en.pdf"},
    {"id":"39332","name":"Presentation - The impact on public and animal health of the use of antibiotics in animals - Discussion on question two (Karolina Tà¶rneke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-public-and-animal-health-use-antibiotics-animals-discussion-question-two-karolina-taprneke_en.pdf"},
    {"id":"39333","name":"Presentation - Pharmacovigilance impact: Update and collaboration with Industry - Ninth industry stakeholder platform on the operation of EU pharmacovigilance","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-02-02T01:00:00Z","last_updated_date":"2017-02-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-impact-update-and-collaboration-industry-ninth-industry-stakeholder-platform-operation-eu-pharmacovigilance_en.pdf"},
    {"id":"39334","name":"GMP Training Course Inspections from an industry perspective - Fiona Routley","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-20T02:09:21Z","last_updated_date":"2009-10-20T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/gmp-training-course-inspections-industry-perspective-fiona-routley_en.pdf"},
    {"id":"39336","name":"Presentation - HTA/payers’ perspective on significant benefit (Niklas Hedberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-15T17:00:00Z","last_updated_date":"2015-12-15T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-htapayers-perspective-significant-benefit-niklas-hedberg_en.pdf"},
    {"id":"39338","name":"Withdrawal assessment report for Effentora","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-08-29T02:00:00Z","last_updated_date":"2013-08-29T02:00:00Z","reference_number":"EMA/CHMP/297003/2013","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-effentora_en.pdf"},
    {"id":"39339","name":"EU/3/16/1819: Public summary of opinion on orphan designation: Humanised IgG1 monoclonal antibody against the receptor-binding site of human placental growth factor for the treatment of medulloblastoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-14T02:00:00Z","last_updated_date":"2017-07-14T02:00:00Z","reference_number":"EMA/4405/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161819-public-summary-opinion-orphan-designation-humanised-igg1-monoclonal-antibody-against-receptor-binding-site-human-placental-growth-factor-treatment-medulloblastoma_en.pdf"},
    {"id":"39340","name":"EU/3/01/025: Public summary of positive opinion for orphan designation of N-acetylgalactosamine-4-sulfatase for the treatment of mucopolysaccharidosis, type VI (Maroteaux-Lamy syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-20T00:00:00Z","last_updated_date":"2016-02-11T00:00:00Z","reference_number":"EMA/COMP/1276/2003 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301025-public-summary-positive-opinion-orphan-designation-n-acetylgalactosamine-4-sulfatase-treatment-mucopolysaccharidosis-type-vi-maroteaux-lamy-syndrome_en.pdf"},
    {"id":"39341","name":"Withdrawal letter: Velcade (bortezomib)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-07-31T17:15:00Z","last_updated_date":"2012-07-31T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-velcade-bortezomib_en.pdf"},
    {"id":"39342","name":"EU/3/16/1626: Public summary of opinion on orphan designation: Acalabrutinib for the treatment of lymphoplasmacytic lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"EMA/COMP/150815/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161626-public-summary-opinion-orphan-designation-acalabrutinib-treatment-lymphoplasmacytic-lymphoma_en.pdf"},
    {"id":"39344","name":"Final assessment report on Andrographis paniculata Nees, folium - First version","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2014-06-10T02:00:00Z","last_updated_date":"2014-08-28T13:05:00Z","reference_number":"EMA/HMPC/320433/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-andrographis-paniculata-nees-folium-first-version_en.pdf"},
    {"id":"39346","name":"Production and quality control of cytokine products derived by biotechnological process","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1990-08-31T02:00:00Z","last_updated_date":"1990-08-31T02:00:00Z","reference_number":"3AB3aen","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/production-and-quality-control-cytokine-products-derived-biotechnological-process_en.pdf"},
    {"id":"39347","name":"PDCO meeting report 16-18 March 2011","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2011-03-25T01:00:00Z","last_updated_date":"2011-03-25T01:00:00Z","reference_number":"EMA/PDCO/213115/2011","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-report-16-18-march-2011_en.pdf"},
    {"id":"39349","name":"Committee for medicinal products for human use summary of positive opinion for Clopidogrel Hexal","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-05-29T02:09:21Z","last_updated_date":"2009-05-29T02:09:21Z","reference_number":"EMEA/CHMP/227915/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-clopidogrel-hexal_en.pdf"},
    {"id":"39350","name":"Pilot project on adaptive licensing","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-19T17:00:00Z","last_updated_date":"2014-03-19T17:00:00Z","reference_number":"EMA/254350/2012","document_url":"https://www.ema.europa.eu/en/documents/other/pilot-project-adaptive-licensing_en.pdf"},
    {"id":"39353","name":"Superseded assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2013-02-15T01:00:00Z","last_updated_date":"2018-08-20T02:00:00Z","reference_number":"EMA/HMPC/560962/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-pelargonium-sidoides-dc-andor-pelargonium-reniforme-curt-radix-first-version_en.pdf"},
    {"id":"39354","name":"Ironwort: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-11-11T01:00:00Z","last_updated_date":"2016-11-11T01:00:00Z","reference_number":"EMA/115825/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/ironwort-summary-public_en.pdf"},
    {"id":"39355","name":"Recognition criteria for self-assessment - European Network of Paediatric Research at the European Medicines Agency: Finnish Investigators Network for Pediatric Medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-07T00:31:00Z","last_updated_date":"2012-05-21T12:00:00Z","reference_number":"EMA/817618/2010","document_url":"https://www.ema.europa.eu/en/documents/other/recognition-criteria-self-assessment-european-network-paediatric-research-european-medicines-agency-finnish-investigators-network-pediatric-medicines_en.pdf"},
    {"id":"39357","name":"Withdrawal of the marketing authorisation for the medicinal product Rotashield - rotavirus vaccine EU/1/99/105/001","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2001-06-07T02:00:00Z","last_updated_date":"2001-06-07T02:00:00Z","reference_number":"EMEA/13002/01","document_url":"https://www.ema.europa.eu/en/documents/public-statement/withdrawal-marketing-authorisation-medicinal-product-rotashield-rotavirus-vaccine-eu199105001_en.pdf"},
    {"id":"39358","name":"Agenda - SME info day on the new clinical trial regulation","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-01-20T10:00:00Z","last_updated_date":"2017-03-16T12:46:00Z","reference_number":"EMA/816344/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sme-info-day-new-clinical-trial-regulation_en.pdf"},
    {"id":"39359","name":"Qualification opinion of novel methodologies in the predementia stage of Alzheimer’s disease: cerebrospinal-fluid-related biomarkers for drugs affecting amyloid burden","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2011-05-16T02:00:00Z","last_updated_date":"2011-05-16T02:00:00Z","reference_number":"EMA/CHMP/SAWP/102001/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-novel-methodologies-predementia-stage-alzheimers-disease-cerebrospinal-fluid-related-biomarkers-drugs-affecting-amyloid-burden_en.pdf"},
    {"id":"39364","name":"Questions and answers on refusal of the marketing authorisation for Dexxience (betrixaban)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/164390/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-dexxience-betrixaban_en.pdf"},
    {"id":"39365","name":"Kytril - Article 30 referral - Annex II","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-09-12T02:00:00Z","last_updated_date":"2011-09-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kytril-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kytril-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kytril-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kytril-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kytril-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kytril-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kytril-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kytril-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kytril-article-30-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kytril-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kytril-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kytril-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kytril-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kytril-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kytril-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kytril-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kytril-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kytril-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kytril-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kytril-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kytril-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kytril-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"39367","name":"Report on the meeting of the Paediatric Human Immunodeficiency Virus (HIV) Expert Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-06T02:00:00Z","last_updated_date":"2010-05-06T02:00:00Z","reference_number":"EMA/339929/2009","document_url":"https://www.ema.europa.eu/en/documents/other/report-meeting-paediatric-human-immunodeficiency-virus-hiv-expert-group_en.pdf"},
    {"id":"39368","name":"Application form for variation to Article 58 CHMP scientific opinion","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-02-07T10:05:00Z","last_updated_date":"2017-09-04T18:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-form-variation-article-58-chmp-scientific-opinion_en.doc"},
    {"id":"39369","name":"Public statement on Venvia (rosiglitazone) - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2005-04-18T14:09:21Z","last_updated_date":"2005-04-18T14:09:21Z","reference_number":"EMEA/41035/2005","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-venvia-rosiglitazone-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"39370","name":"Annex B2 - Other criteria essential to ensure that EMA remains operational to guarantee business continuity - EMA contributions (detailed tables)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-03T20:15:00Z","last_updated_date":"2017-10-03T20:15:00Z","reference_number":"EMA/606203/2017","document_url":"https://www.ema.europa.eu/en/documents/other/annex-b2-other-criteria-essential-ensure-ema-remains-operational-guarantee-business-continuity-ema-contributions-detailed-tables_en.pdf"},
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    {"id":"39415","name":"EU/3/05/326: Public summary of positive opinion for orphan designation of peptide 144 TGF-beta1-inhibitor (TSLDASIIWAMMQN) for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-05-30T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"EMEA/COMP/315308/2005 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305326-public-summary-positive-opinion-orphan-designation-peptide-144-tgf-beta1-inhibitor-tsldasiiwammqn-treatment-systemic-sclerosis_en.pdf"},
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    {"id":"39479","name":"Response to the questions raised by the qualification team - CHMP qualification opinion on efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-10-15T19:00:00Z","last_updated_date":"2013-10-15T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/response-questions-raised-qualification-team-chmp-qualification-opinion-efficient-statistical-methodology-model-based-design-and-analysis-phase-ii-dose-finding-studies-under-model-uncertainty_en.pdf"},
    {"id":"39482","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 19 to 21 February 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-02-21T00:09:21Z","last_updated_date":"2002-02-21T00:09:21Z","reference_number":"EMEA/CPMP/561/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-19-21-february-2002_en.pdf"},
    {"id":"39483","name":"Symbioflor 2 Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-09-07T02:00:00Z","last_updated_date":"2017-09-07T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/symbioflor-2-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/symbioflor-2-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/symbioflor-2-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/symbioflor-2-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/symbioflor-2-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/symbioflor-2-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/symbioflor-2-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/symbioflor-2-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/symbioflor-2-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/symbioflor-2-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/symbioflor-2-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/symbioflor-2-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/symbioflor-2-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/symbioflor-2-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/symbioflor-2-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/symbioflor-2-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/symbioflor-2-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/symbioflor-2-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/symbioflor-2-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/symbioflor-2-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/symbioflor-2-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/symbioflor-2-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/symbioflor-2-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"39484","name":"Presentation - Feedback from teleconference on handling of conflicts of interest for patients' and consumers' organisations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-24T18:30:00Z","last_updated_date":"2013-05-24T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-teleconference-handling-conflicts-interest-patients-and-consumers-organisations_en.pdf"},
    {"id":"39489","name":"Management Board delays formal adoption of EMA publication of clinical trial data policy to October 2014","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-07-09T02:00:00Z","last_updated_date":"2014-07-09T02:00:00Z","reference_number":"EMA/415308/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/management-board-delays-formal-adoption-ema-publication-clinical-trial-data-policy-october-2014_en.pdf"},
    {"id":"39490","name":"Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-02-01T11:40:00Z","last_updated_date":"2018-02-01T11:40:00Z","reference_number":"EMA/630043/2008","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-evaluation-advanced-therapy-medicinal-product-accordance-article-8-regulation-ec-no-13942007_en.pdf"},
    {"id":"39491","name":"Handling competing interests: revised rules for Management Board members","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-01-14T01:00:00Z","last_updated_date":"2016-01-14T01:00:00Z","reference_number":"EMA/6697/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/handling-competing-interests-revised-rules-management-board-members_en.pdf"},
    {"id":"39496","name":"Presentation - Early engagement and support for medicine development (Stiina Aarum)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-engagement-and-support-medicine-development-stiina-aarum_en.pdf"},
    {"id":"39497","name":"Presentation - Engineered CAR-T therapies (Julianne Smith)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-02T10:22:00Z","last_updated_date":"2016-12-02T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-engineered-car-t-therapies-julianne-smith_en.pdf"},
    {"id":"39500","name":"EMEA template for the cover letter submission of PSURs data","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2009-06-19T02:09:21Z","last_updated_date":"2009-06-19T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/emea-template-cover-letter-submission-psurs-data_en.doc"},
    {"id":"39502","name":"Scientific recommendation on classification of advanced\n\ntherapy medicinal products: Autologous human mesenchymal stem cells present in bone marrow cells suspension","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:59:00Z","last_updated_date":"2018-01-03T14:59:00Z","reference_number":"EMA/699041/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-human-mesenchymal-stem-cells-present-bone-marrow-cells-suspension_en.pdf"},
    {"id":"39503","name":"Presentation - European Group for Generic Veterinary Products (EGGVP) comments (Elsa Vecino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-group-generic-veterinary-products-eggvp-comments-elsa-vecino_en.pdf"},
    {"id":"39505","name":"Structure for the operation of the EnprEMA elaborated working group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-05-31T02:00:00Z","last_updated_date":"2010-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/structure-operation-enprema-elaborated-working-group_en.pdf"},
    {"id":"39506","name":"Overview of comments received on the Core SPC for human Anti-D immunoglobulin for intravenous use CPMP/BPWP/319619/2005","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-07-13T02:00:00Z","last_updated_date":"2007-07-13T02:00:00Z","reference_number":"EMEA/CHMP/BPWP/74960/2007","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-core-spc-human-anti-d-immunoglobulin-intravenous-use-cpmpbpwp3196192005_en.pdf"},
    {"id":"39508","name":"CHMP post-authorisation summary of positive opinion for Faslodex","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T14:00:00Z","last_updated_date":"2017-06-23T14:00:00Z","reference_number":"EMA/CHMP/398319/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-faslodex_en.pdf-0"},
    {"id":"39511","name":"Guidance on format of the risk-management plan in the European Union part V: Risk-minimisation measures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-11-14T01:00:00Z","last_updated_date":"2012-11-14T01:00:00Z","reference_number":"EMA/715019/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-european-union-part-v-risk-minimisation-measures_en.doc"},
    {"id":"39512","name":"Points to consider on the evaluation of diagnostic agents","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2001-11-15T01:00:00Z","last_updated_date":"2001-11-15T01:00:00Z","reference_number":"CPMP/EWP/1119/98","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-evaluation-diagnostic-agents_en.pdf"},
    {"id":"39517","name":"ESGCT/ICH Workshop on Viral Vector Shedding 2 - Klaus Cichutek","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-10-30T00:09:21Z","last_updated_date":"2007-10-30T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/esgctich-workshop-viral-vector-shedding-2-klaus-cichutek_en.pdf"},
    {"id":"39518","name":"Reflection paper on medicinal-product supply shortages caused by manufacturing / good-manufacturing-practice compliance problems - Implementation plan 2012-2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-23T16:35:00Z","last_updated_date":"2012-11-23T16:35:00Z","reference_number":"EMA/708575/2012","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-medicinal-product-supply-shortages-caused-manufacturing-good-manufacturing-practice-compliance-problems-implementation-plan-2012-2015_en.pdf"},
    {"id":"39519","name":"EU/3/14/1308: Public summary of opinion on orphan designation: Sodium ascorbate and menadione sodium bisulfite for the treatment of autosomal dominant polycystic liver disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/COMP/443070/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141308-public-summary-opinion-orphan-designation-sodium-ascorbate-and-menadione-sodium-bisulfite-treatment-autosomal-dominant-polycystic-liver-disease_en.pdf"},
    {"id":"39520","name":"Public statement on LeukoScan: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T01:00:00Z","last_updated_date":"2018-02-09T01:00:00Z","reference_number":"EMA/70932/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-leukoscan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"39522","name":"Reflection paper on the use of cocrystals of active substances in medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-07-16T18:10:02Z","last_updated_date":"2015-07-16T18:10:02Z","reference_number":"EMA/CHMP/CVMP/QWP/284008/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-cocrystals-active-substances-medicinal-products_en.pdf"},
    {"id":"39523","name":"Policy 9: Appropriate coordination between the Agency's scientific committees","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2008-10-31T01:00:00Z","last_updated_date":"2008-10-31T01:00:00Z","reference_number":"EMEA/124704/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/policy-9-appropriate-coordination-between-agencys-scientific-committees_en.pdf"},
    {"id":"39527","name":"Superseded assessment report on Aesculus hippocastanum L., semen - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:00:00Z","last_updated_date":"2020-04-23T02:00:00Z","reference_number":"EMEA/HMPC/225304/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-aesculus-hippocastanum-l-semen-first-version_en.pdf"},
    {"id":"39529","name":"Pharmacovigilance Inspections - Johanna Piper","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-11-14T00:09:21Z","last_updated_date":"2008-11-14T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/pharmacovigilance-inspections-johanna-piper_en.pdf"},
    {"id":"39530","name":"EU/3/12/953: Public summary of opinion on orphan designation: (1S,3S)-3-amino-4-(difluoromethylene) cyclopentanecarboxylic acid hydrochloride for the treatment of West syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2012-03-01T01:00:00Z","reference_number":"EMA/COMP/41120/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312953-public-summary-opinion-orphan-designation-1s3s-3-amino-4-difluoromethylene-cyclopentanecarboxylic-acid-hydrochloride-treatment-west-syndrome_en.pdf"},
    {"id":"39531","name":"Questions and answers on Sandostatin and associated names (octreotide, 0.05 mg/1 ml, 0.1 mg/1 ml, 0.5 mg/1 ml and 1 mg/5 ml, solution for injection or infusion)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T14:00:00Z","last_updated_date":"2014-06-27T14:00:00Z","reference_number":"EMA/376438/2014 ","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-sandostatin-and-associated-names-octreotide-005-mg1-ml-01-mg1-ml-05-mg1-ml-and-1-mg5-ml-solution-injection-or-infusion_en.pdf"},
    {"id":"39532","name":"Presentation - Breakout session - Neonatal abstinence syndrome (John Van Den Anker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-neonatal-abstinence-syndrome-john-van-den-anker_en.pdf"},
    {"id":"39533","name":"Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood com...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-02-07T00:09:21Z","last_updated_date":"2003-02-07T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/directive-200298ec-european-parliament-and-council-27-january-2003-setting-standards-quality-and-safety-collection-testing-processing-storage-and-distribution-human-blood-and-blood-com_en.pdf"},
    {"id":"39534","name":"Pathogen-specific database: Annex: Biological agents for which currently no specific treatment can be recommended","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-05T01:00:00Z","last_updated_date":"2008-11-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pathogen-specific-database-annex-biological-agents-which-currently-no-specific-treatment-can-be-recommended_en.pdf"},
    {"id":"39538","name":"EU/3/08/540: Public summary of positive opinion for orphan designation of omigapil maleate for the treatment of congenital muscular dystrophy with collagen VI deficiency (Ullrich Syndrome and Bethlem Myopathy)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-07-29T02:00:00Z","last_updated_date":"2011-04-12T02:00:00Z","reference_number":"EMEA/COMP/204727/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308540-public-summary-positive-opinion-orphan-designation-omigapil-maleate-treatment-congenital-muscular-dystrophy-collagen-vi-deficiency-ullrich-syndrome-and-bethlem-myopathy_en.pdf"},
    {"id":"39542","name":"Overview of current initiatives at European Union level to assist micro, small and medium-sized enterprises with financing","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-21T17:38:22Z","last_updated_date":"2015-02-04T15:30:00Z","reference_number":"EMA/986534/2011","document_url":"https://www.ema.europa.eu/en/documents/other/overview-current-initiatives-european-union-level-assist-micro-small-and-medium-sized-enterprises-financing_en.pdf"},
    {"id":"39543","name":"15% decrease in sales of veterinary antibiotics in Europe","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-10-15T02:00:00Z","last_updated_date":"2014-10-15T02:00:00Z","reference_number":"EMA/619398/2014 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/15-decrease-sales-veterinary-antibiotics-europe_en.pdf"},
    {"id":"39544","name":"Withdrawal assessment report for Cerepro","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-02-01T01:00:00Z","last_updated_date":"2011-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-cerepro_en.pdf-0"},
    {"id":"39545","name":"Standard operating procedure for processing of annual update notifications for parallel distribution","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2015-05-08T18:20:00Z","last_updated_date":"2015-05-08T18:20:00Z","reference_number":"SOP/INS/2058","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-processing-annual-update-notifications-parallel-distribution_en.pdf"},
    {"id":"39547","name":"Domperidone Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-03-08T01:00:00Z","last_updated_date":"2013-03-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/domperidone-article-31-referral-notification_en.pdf"},
    {"id":"39549","name":"Committee for Medicinal Products for Human Use (CHMP) - March 2004 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2004-04-01T02:00:00Z","last_updated_date":"2004-04-01T02:00:00Z","reference_number":"EMEA/CPMP/1238/04","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-march-2004-plenary-meeting-monthly-report_en.pdf"},
    {"id":"39555","name":"Guideline on validation of immunoassay for the detection of hepatitis B virus surface antigen (HBSAG) in plasma pools","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-09-21T02:00:00Z","last_updated_date":"2006-09-21T02:00:00Z","reference_number":"EMEA/CHMP/BWP/298390/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-validation-immunoassay-detection-hepatitis-b-virus-surface-antigen-hbsag-plasma-pools_en.pdf"},
    {"id":"39556","name":"EU/3/16/1750: Public summary of positive opinion for orphan designation of exendin (9-39) for the treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/622426/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161750-public-summary-positive-opinion-orphan-designation-exendin-9-39-treatment-noninsulinoma-pancreatogenous-hypoglycaemia-syndrome_en.pdf"},
    {"id":"39558","name":"Overview of comments received on 'Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-08-03T13:00:00Z","last_updated_date":"2018-08-03T13:00:00Z","reference_number":"EMA/CHMP/395071/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-cholic-acid-capsules-50-mg-and-250-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"39559","name":"Presentation - Exploratory subgroup analysis: Post-hoc subgroup identification in clinical trials (Alex Dmitrienko, Ilya Lipkovich)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T01:00:00Z","last_updated_date":"2015-03-02T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-exploratory-subgroup-analysis-post-hoc-subgroup-identification-clinical-trials-alex-dmitrienko-ilya-lipkovich_en.pdf"},
    {"id":"39560","name":"Definition of Starting Materials - Christina Hoejelse","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:09:21Z","last_updated_date":"2009-10-27T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/definition-starting-materials-christina-hoejelse_en.pdf"},
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    {"id":"39625","name":"Overview of comments received on ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot and mouth disease (FMD)’ - First version","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-03-18T01:00:00Z","last_updated_date":"2010-03-18T01:00:00Z","reference_number":"EMA/33491/2010","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-first-version_en.pdf"},
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    {"id":"39638","name":"Guideline on non-clinical and clinical development of medicinal products for the treatment of nausea and vomiting associated with cancer chemotherapy","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-12-14T00:09:21Z","last_updated_date":"2006-12-14T00:09:21Z","reference_number":"CPMP/EWP/4937/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-and-clinical-development-medicinal-products-treatment-nausea-and-vomiting-associated-cancer-chemotherapy_en.pdf"},
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    {"id":"39642","name":"EMEA launches action plan for improvements for human medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-01-14T01:00:00Z","last_updated_date":"2004-01-14T01:00:00Z","reference_number":"EMEA/H/885/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-launches-action-plan-improvements-human-medicines_en.pdf"},
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    {"id":"39700","name":"Flunixin (extension to horses): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-06-01T02:00:00Z","last_updated_date":"2000-06-01T02:00:00Z","reference_number":"EMEA/MRL/744/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flunixin-extension-horses-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39701","name":"EU/3/15/1529: Public summary of opinion on orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid for the treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-08-18T14:00:00Z","last_updated_date":"2015-08-18T14:00:00Z","reference_number":"EMA/COMP/425722/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151529-public-summary-opinion-orphan-designation-glycyl-l-2-methylprolyl-l-glutamic-acid-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"39705","name":"Presentation - Disseminating European Medicines Agency information (Monika Benstetter, Sarah Weatherley, Christopher Gadd)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-disseminating-european-medicines-agency-information-monika-benstetter-sarah-weatherley-christopher-gadd_en.pdf"},
    {"id":"39707","name":"EU/3/16/1782: Public summary of positive opinion for orphan designation of L-selenomethionine for the treatment of facioscapulohumeral muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T13:06:00Z","last_updated_date":"2016-12-14T13:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161782-public-summary-positive-opinion-orphan-designation-l-selenomethionine-treatment-facioscapulohumeral-muscular-dystrophy_en.pdf"},
    {"id":"39708","name":"Proposed invented name(s) justification form for human medicinal products","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2006-07-01T02:00:00Z","last_updated_date":"2006-07-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/proposed-invented-names-justification-form-human-medicinal-products_en.doc"},
    {"id":"39709","name":"Presentation - Poorly water soluble substances: challenges, options and limitations for children","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-poorly-water-soluble-substances-challenges-options-and-limitations-children_en.pdf"},
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    {"id":"39714","name":"EU/3/06/352: Public summary of positive opinion for orphan designation of 26 base single stranded phosphodiester DNA oligonucleotide for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-17T02:00:00Z","last_updated_date":"2011-05-18T02:00:00Z","reference_number":"EMEA/COMP/25354/2006 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306352-public-summary-positive-opinion-orphan-designation-26-base-single-stranded-phosphodiester-dna-oligonucleotide-treatment-pancreatic-cancer_en.pdf"},
    {"id":"39717","name":"Guideline on good pharmacovigilance practices: Module IX – Signal management (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T19:18:16Z","last_updated_date":"2012-06-25T19:18:16Z","reference_number":"EMA/827661/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ix-signal-management-superseded_en.pdf"},
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    {"id":"39719","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 12-14 August 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T13:25:00Z","last_updated_date":"2015-08-20T13:25:00Z","reference_number":"EMA/PDCO/492280/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-12-14-august-2015_en.pdf"},
    {"id":"39720","name":"Meloxicam (Extrapolation to rabbits and goats): Summary report (7) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2006-05-01T02:00:00Z","last_updated_date":"2006-05-01T02:00:00Z","reference_number":"EMEA/CVMP/152255/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/meloxicam-extrapolation-rabbits-and-goats-summary-report-7-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39723","name":"Presentation - Session 4: What defines the disease and populations? How to deal with large subgroups within an indication? Heterogeneity, lack of historical real-life data, rarest subtype (Jan Bogaerts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-what-defines-disease-and-populations-how-deal-large-subgroups-within-indication-heterogeneity-lack-historical-real-life-data-rarest-subtype-jan-bogaerts_en.pdf"},
    {"id":"39729","name":"Guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2013-01-24T01:00:00Z","last_updated_date":"2013-01-24T01:00:00Z","reference_number":"EMA/118465/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xv-safety-communication-superseded_en.pdf"},
    {"id":"39730","name":"Pegylated bovine granulocyte colony stimulating factor (PEGbG-CSF) (bovine species): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T12:16:00Z","last_updated_date":"2012-03-15T12:16:00Z","reference_number":"EMA/CVMP/190918/2010","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/pegylated-bovine-granulocyte-colony-stimulating-factor-pegbg-csf-bovine-species-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"39731","name":"Final Community herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-06-09T02:00:00Z","last_updated_date":"2016-06-09T02:00:00Z","reference_number":"EMA/HMPC/84990/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"39732","name":"Open invitation to tender, EMEA/2008/40/ES, Services to support EMEA's online communications activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-03-05T01:00:00Z","last_updated_date":"2008-03-05T01:00:00Z","reference_number":"EMEA/3525/04/5736","document_url":"https://www.ema.europa.eu/en/documents/other/open-invitation-tender-emea200840es-services-support-emeas-online-communications-activities_en.pdf"},
    {"id":"39736","name":"Lormetazepam: List of nationally authorised medicinal products - PSUSA/00001910/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-11-09T01:00:00Z","last_updated_date":"2016-10-18T10:40:09Z","reference_number":"EMA/739247/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/lormetazepam-list-nationally-authorised-medicinal-products-psusa00001910201412_en.pdf"},
    {"id":"39737","name":"Honey bee diseases – the current situation in Greece, Angeliki Tsigouri, National Organisation for Medicines (Greece)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-22T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/honey-bee-diseases-current-situation-greece-angeliki-tsigouri-national-organisation-medicines-greece_en.pdf"},
    {"id":"39738","name":"Application form: Call for expression of interest - EMA/2012/59/PD \"Provision of access to databases / electronic resources\"","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-12-17T01:00:00Z","last_updated_date":"2015-07-14T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-form-call-expression-interest-ema201259pd-provision-access-databases-electronic-resources_en.pdf"},
    {"id":"39743","name":"EU/3/10/741: Public summary of opinion on orphan designation: Pralatrexate for the treatment of cutaneous T-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-06-24T02:00:00Z","last_updated_date":"2011-03-10T01:00:00Z","reference_number":"EMA/COMP/90948/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310741-public-summary-opinion-orphan-designation-pralatrexate-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
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    {"id":"39747","name":"Final overview of comments received on Public statement on Paeonia lactiflora Pall. and/or Paeonia veitchii Lynch, radix (Paeoniae radix rubra)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2017-04-25T17:35:00Z","last_updated_date":"2017-04-25T17:35:00Z","reference_number":"EMA/HMPC/610812/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/final-overview-comments-received-public-statement-paeonia-lactiflora-pall-andor-paeonia-veitchii-lynch-radix-paeoniae-radix-rubra_en.pdf"},
    {"id":"39752","name":"Presentation - Natural history of neuromyelitis optica (Friedemann Paul)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-10-23T02:00:00Z","last_updated_date":"2014-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-natural-history-neuromyelitis-optica-friedemann-paul_en.pdf"},
    {"id":"39754","name":"Valganciclovir: List of nationally authorised medicinal products - PSUSA/00003089/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-05T10:07:00Z","last_updated_date":"2016-12-05T10:08:43Z","reference_number":"EMA/750653/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/valganciclovir-list-nationally-authorised-medicinal-products-psusa00003089201603_en.pdf"},
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    {"id":"39757","name":"EU/3/12/992: Public summary of opinion on orphan designation: Exon-53-specific phosphorothioate oligonucleotide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-06-18T13:00:00Z","last_updated_date":"2012-06-18T13:00:00Z","reference_number":"EMA/COMP/193933/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312992-public-summary-opinion-orphan-designation-exon-53-specific-phosphorothioate-oligonucleotide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"39758","name":"Bromocriptine Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-21T02:00:00Z","last_updated_date":"2014-12-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/bromocriptine-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/bromocriptine-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/bromocriptine-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/bromocriptine-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/bromocriptine-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/bromocriptine-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/bromocriptine-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/bromocriptine-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/bromocriptine-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/bromocriptine-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/bromocriptine-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/bromocriptine-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/bromocriptine-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/bromocriptine-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/bromocriptine-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/bromocriptine-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/bromocriptine-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/bromocriptine-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/bromocriptine-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/bromocriptine-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/bromocriptine-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/bromocriptine-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/bromocriptine-article-31-referral-annex-iii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/bromocriptine-article-31-referral-annex-iii_no.pdf"}},
    {"id":"39759","name":"EU Telematics, HG Wagner, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-telematics-hg-wagner-ema_en.pdf"},
    {"id":"39760","name":"Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-01-03T17:39:00Z","last_updated_date":"2017-01-03T17:39:00Z","reference_number":"EMA/CHMP/154805/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/pazopanib-film-coated-tablet-200-mg-and-400-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"39761","name":"Agenda - Meeting on redacting commercially confidential information (CCI) in clinical reports and anonymising clinical reports for the purpose of publication","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2015-07-01T15:20:00Z","last_updated_date":"2015-07-01T15:20:00Z","reference_number":"EMA/431518/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-meeting-redacting-commercially-confidential-information-cci-clinical-reports-and-anonymising-clinical-reports-purpose-publication_en.pdf"},
    {"id":"39762","name":"Hearing with interested parties - Minutes","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2006-01-12T01:00:00Z","last_updated_date":"2006-01-12T01:00:00Z","reference_number":"EMEA/HMPC/405043/2005","document_url":"https://www.ema.europa.eu/en/documents/minutes/hearing-interested-parties-minutes_en.pdf"},
    {"id":"39765","name":"European Medicines Agency updates on pandemic influenza","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-01-22T01:00:00Z","last_updated_date":"2010-01-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-updates-pandemic-influenza_en.pdf-0"},
    {"id":"39768","name":"Questions and answers on the review of gadolinium-containing contrast agents","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-11-21T00:59:00Z","last_updated_date":"2010-09-02T01:59:00Z","reference_number":"EMEA/727399/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-gadolinium-containing-contrast-agents_sv.pdf"}},
    {"id":"39769","name":"Explanatory note on fees payable to the European Medicines Agency","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-03-30T11:10:03Z","last_updated_date":"2013-03-27T13:20:00Z","reference_number":"EMA/21385/2013","document_url":"https://www.ema.europa.eu/en/documents/other/explanatory-note-fees-payable-european-medicines-agency_en.pdf-1"},
    {"id":"39771","name":"Draft guideline on the Core SPC for human Anti-D immunoglobulin for intravenous use – Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-04-27T02:09:21Z","last_updated_date":"2006-04-27T02:09:21Z","reference_number":"CHMP/BPWP/319619/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-spc-human-anti-d-immunoglobulin-intravenous-use-revision-1_en.pdf"},
    {"id":"39773","name":"European Commission request for joint opinion","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-28T16:00:00Z","last_updated_date":"2015-04-28T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-commission-request-joint-opinion_en.pdf"},
    {"id":"39774","name":"ICH: S 5 (R2): Detection of toxicity to reproduction for medicinal products & toxicity to male fertility - Step 5 - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"1993-09-30T01:00:00Z","last_updated_date":"1993-09-30T01:00:00Z","reference_number":"CPMP/ICH/386/95","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-5-r2-detection-toxicity-reproduction-medicinal-products-toxicity-male-fertility-step-5-revision-2_en.pdf"},
    {"id":"39778","name":"Presentation - The place for treatments of associated neuropsychiatric and other symptoms - focus on challenges of the clinical diagnosis of Alzheimer's disease (Reinhold Schmidt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-12-01T13:00:00Z","last_updated_date":"2014-12-01T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-place-treatments-associated-neuropsychiatric-and-other-symptoms-focus-challenges-clinical-diagnosis-alzheimers-disease-reinhold-schmidt_en.pdf"},
    {"id":"39779","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T12:00:00Z","last_updated_date":"2016-10-20T12:00:00Z","reference_number":"EMA/CAT/675972/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-october-2016_en.pdf"},
    {"id":"39780","name":"EU/3/12/954: Public summary of opinion on orphan designation: S[+] apomorphine for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-03-01T01:00:00Z","last_updated_date":"2012-03-28T16:30:00Z","reference_number":"EMA/COMP/5395/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312954-public-summary-opinion-orphan-designation-s-apomorphine-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"39781","name":"CHMP summary of positive opinion for Tepadina","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-12-17T01:00:00Z","last_updated_date":"2009-12-17T01:00:00Z","reference_number":"EMA/CHMP/720221/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tepadina_en.pdf"},
    {"id":"39783","name":"European Medicines Agency advises on compassionate use of a new combination therapy for chronic hepatitis C","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-02-21T13:00:00Z","last_updated_date":"2014-02-21T13:00:00Z","reference_number":"EMA/104898/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-advises-compassionate-use-new-combination-therapy-chronic-hepatitis-c_en.pdf"},
    {"id":"39784","name":"Opinion of the HMPC on a European Union herbal monograph on Symphytum officinale L., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-06-05T02:00:00Z","last_updated_date":"2015-06-05T02:00:00Z","reference_number":"EMA/HMPC/292905/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-symphytum-officinale-l-radix_en.pdf"},
    {"id":"39785","name":"Reflection paper on the use of genomics in cardiovascular clinical intervention trials","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2007-11-15T01:00:00Z","last_updated_date":"2007-11-15T01:00:00Z","reference_number":"EMEA/CHMP/PGxWP/278789/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-genomics-cardiovascular-clinical-intervention-trials_en.pdf"},
    {"id":"39786","name":"Presentation - Use of Subgroups to “Rescue” a Trial or Improve Benefit-Risk (King)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-28T11:54:00Z","last_updated_date":"2011-11-28T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-subgroups-rescue-trial-or-improve-benefit-risk-king_en.pdf"},
    {"id":"39788","name":"Fusidic acid (systemic use): List of nationally authorised medicinal products - PSUSA/00010226/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-01-17T12:00:00Z","last_updated_date":"2017-01-17T12:00:00Z","reference_number":"EMA/32524/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/fusidic-acid-systemic-use-list-nationally-authorised-medicinal-products-psusa00010226201605_en.pdf"},
    {"id":"39790","name":"PCWP/HCPWP Session on communication and information on medicines 8 March 2016 - Speakers’ biographies","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"EMA/52928/2016","document_url":"https://www.ema.europa.eu/en/documents/other/pcwphcpwp-session-communication-and-information-medicines-8-march-2016-speakers-biographies_en.pdf"},
    {"id":"39791","name":"Ceftiofur: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/498/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ceftiofur-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39792","name":"CVMP post-authorisation summary of positive opinion for Metacam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-11-09T16:30:00Z","last_updated_date":"2012-11-09T16:30:00Z","reference_number":"EMA/CVMP/585201/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam_en.pdf-7"},
    {"id":"39794","name":"Presentation - Unmet medical need (J. Llinares, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-unmet-medical-need-j-llinares-ema_en.pdf"},
    {"id":"39795","name":"EU/3/13/1162: Public summary of opinion on orphan designation: Heterologous human adult liver-derived progenitor cells for the treatment of citrullinaemia type 1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T14:30:00Z","last_updated_date":"2013-08-21T14:30:00Z","reference_number":"EMA/COMP/413213/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131162-public-summary-opinion-orphan-designation-heterologous-human-adult-liver-derived-progenitor-cells-treatment-citrullinaemia-type-1_en.pdf"},
    {"id":"39796","name":"Agenda - Periodic safety update report information day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-06-14T15:50:00Z","last_updated_date":"2016-10-04T13:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-periodic-safety-update-report-information-day_en.pdf"},
    {"id":"39797","name":"Assessment report for KETOPROFEN containing medicinal products (topical formulations)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"EMA/824183/2011","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-ketoprofen-containing-medicinal-products-topical-formulations_en.pdf"},
    {"id":"39798","name":"EU/3/02/087: Public summary of positive opinion for orphan designation of eflornithine hydrochloride for the treatment of Familial Adenomatous Polyposis (FAP)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T01:00:00Z","last_updated_date":"2005-11-29T01:00:00Z","reference_number":"EMEA/COMP/91/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302087-public-summary-positive-opinion-orphan-designation-eflornithine-hydrochloride-treatment-familial-adenomatous-polyposis-fap_en.pdf"},
    {"id":"39799","name":"CHMP summary of positive opinion for Zubsolv","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-09-15T02:00:00Z","last_updated_date":"2017-09-15T02:00:00Z","reference_number":"EMA/CHMP/535541/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zubsolv_en.pdf"},
    {"id":"39801","name":"Summary of quality differences form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-01-19T15:00:00Z","last_updated_date":"2015-01-19T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/summary-quality-differences-form_en.docx"},
    {"id":"39802","name":"Agenda - Stakeholder meeting on Product Shortages due to manufacturing and quality problems: developing a proactive approach to prevention","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2015-10-08T02:00:00Z","last_updated_date":"2015-10-08T02:00:00Z","reference_number":"EMA/INS/GMP/665392/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-stakeholder-meeting-product-shortages-due-manufacturing-and-quality-problems-developing-proactive-approach-prevention_en.pdf"},
    {"id":"39805","name":"Presentation - Veterinary pharmacovigilance: Outline of the EU pharmacovigilance system","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-pharmacovigilance-outline-eu-pharmacovigilance-system_en.pdf"},
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    {"id":"39807","name":"Divergent position on a CVMP opinion on an Article-33(4) referral of Directive 2001/82/EC for Fiprex CAT 52.5 mg spot-on solution for cats, and Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution f...","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-14T02:00:00Z","last_updated_date":"2014-08-14T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-334-referral-directive-200182ec-fiprex-cat-525-mg-spot-solution-cats-and-fiprex-s-75-mg-spot-solution-dogs-fiprex-m-150-mg-spot-solution-f_en.pdf"},
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    {"id":"39814","name":"Prevora - Article 29 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2011-09-20T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/prevora-article-29-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/prevora-article-29-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/prevora-article-29-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/prevora-article-29-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/prevora-article-29-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/prevora-article-29-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/prevora-article-29-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/prevora-article-29-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/prevora-article-29-referral-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/prevora-article-29-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/prevora-article-29-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/prevora-article-29-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/prevora-article-29-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/prevora-article-29-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/prevora-article-29-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/prevora-article-29-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/prevora-article-29-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/prevora-article-29-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/prevora-article-29-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/prevora-article-29-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/prevora-article-29-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/prevora-article-29-referral-annex-ii_sv.pdf"}},
    {"id":"39816","name":"Guideline on the Core SPC for human Albumin solution\n\n(CPMP/PhVWP/BPWG/2231/99 rev.2)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"CPMP/PhVWP/BPWG/2231/99/Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-spc-human-albumin-solution-cpmpphvwpbpwg223199-rev2_en.pdf"},
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    {"id":"39819","name":"Submission of general comments on good pharmacovigilance practices","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2012-02-22T13:20:00Z","last_updated_date":"2012-02-22T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-general-comments-good-pharmacovigilance-practices_en.doc"},
    {"id":"39820","name":"Final opinion of the HMPC on a Community herbal monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T13:00:00Z","last_updated_date":"2014-05-12T13:00:00Z","reference_number":"EMA/HMPC/55203/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-community-herbal-monograph-curcuma-xanthorrhiza-roxb-c-xanthorrhiza-d-dietrich-rhizoma_en.pdf"},
    {"id":"39821","name":"Guidelines and concept papers adopted during the CHMP meeting 22-25 February 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-03-04T15:00:00Z","last_updated_date":"2016-03-04T15:00:00Z","reference_number":"EMA/76582/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-22-25-february-2016_en.pdf"},
    {"id":"39822","name":"EMEA announces new CPMP chairman and vice-chairman","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2001-01-23T00:09:21Z","last_updated_date":"2001-01-23T00:09:21Z","reference_number":"EMEA/D/1568/01","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-announces-new-cpmp-chairman-and-vice-chairman_en.pdf"},
    {"id":"39825","name":"CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - Second draft and comments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag4-advice-european-medicines-agency-clinical-trial-advisory-group-good-analysis-practice-second-draft-and-comments_en.pdf"},
    {"id":"39826","name":"EMEA concludes new advice to doctors and patients for Tysabri (natalizumab) needed","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T00:09:21Z","last_updated_date":"2008-03-20T00:09:21Z","reference_number":"EMEA/CHMP/139489/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-concludes-new-advice-doctors-and-patients-tysabri-natalizumab-needed_en.pdf"},
    {"id":"39827","name":"Furosemide Vitabalans Article-29(4) - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-30T17:30:00Z","last_updated_date":"2013-07-30T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/furosemide-vitabalans-article-294-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/furosemide-vitabalans-article-294-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/furosemide-vitabalans-article-294-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/furosemide-vitabalans-article-294-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/furosemide-vitabalans-article-294-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/furosemide-vitabalans-article-294-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/furosemide-vitabalans-article-294-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/furosemide-vitabalans-article-294-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/furosemide-vitabalans-article-294-annex-ii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/furosemide-vitabalans-article-294-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/furosemide-vitabalans-article-294-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/furosemide-vitabalans-article-294-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/furosemide-vitabalans-article-294-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/furosemide-vitabalans-article-294-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/furosemide-vitabalans-article-294-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/furosemide-vitabalans-article-294-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/furosemide-vitabalans-article-294-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/furosemide-vitabalans-article-294-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/furosemide-vitabalans-article-294-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/furosemide-vitabalans-article-294-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/furosemide-vitabalans-article-294-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/furosemide-vitabalans-article-294-annex-ii_sv.pdf"}},
    {"id":"39829","name":"Opinion following an Article 34 referral Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix and associated names: Background 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    {"id":"39831","name":"Experience following implementation of revised policy on handling of conflicts of interests - Guidance on completion of electronic declaration of interests (S. Kennedy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-02-12T01:00:00Z","last_updated_date":"2013-02-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/experience-following-implementation-revised-policy-handling-conflicts-interests-guidance-completion-electronic-declaration-interests-s-kennedy_en.pdf"},
    {"id":"39833","name":"Albendazole: Summary Report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-06-01T02:00:00Z","last_updated_date":"2004-06-01T02:00:00Z","reference_number":"EMEA/MRL/865/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/albendazole-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39836","name":"Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201610","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-06-12T10:45:00Z","last_updated_date":"2017-06-12T11:05:47Z","reference_number":"EMA/359582/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylphenidate-list-nationally-authorised-medicinal-products-psusa00002024201610_en.pdf"},
    {"id":"39838","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2007-09-07T02:00:00Z","last_updated_date":"2007-09-07T02:00:00Z","reference_number":"EMEA/HMPC/405542/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"39843","name":"Presentation - Advice on regulatory strategy, Ms Zaide Frias","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-06T02:00:00Z","last_updated_date":"2011-06-06T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-advice-regulatory-strategy-ms-zaide-frias_en.pdf"},
    {"id":"39845","name":"Committee for Orphan Medicinal Products: May 2006 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-05-17T02:00:00Z","last_updated_date":"2006-05-17T02:00:00Z","reference_number":"EMEA/COMP/180251/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-orphan-medicinal-products-may-2006-meeting_en.pdf"},
    {"id":"39846","name":"Opinion of the CVMP on the establishment of maximum residue limits: Cabergoline","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-09-08T19:00:00Z","last_updated_date":"2014-09-08T19:00:00Z","reference_number":"EMA/CVMP/660284/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-cabergoline_en.pdf"},
    {"id":"39848","name":"Presentation - Session 3: How could molecular profiling impact histology independent labels in the future? (Marlene Thomas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-how-could-molecular-profiling-impact-histology-independent-labels-future-marlene-thomas_en.pdf"},
    {"id":"39849","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T02:00:00Z","last_updated_date":"2012-06-22T02:00:00Z","reference_number":"EMA/CHMP/422860/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-9"},
    {"id":"39851","name":"EMEA Public statement on herbal medicinal products containing cimicifugae racemosae rhizoma - Serious hepatic reactions","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2006-07-18T02:00:00Z","last_updated_date":"2006-07-18T02:00:00Z","reference_number":"EMEA/269259/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-herbal-medicinal-products-containing-cimicifugae-racemosae-rhizoma-serious-hepatic-reactions_en.pdf"},
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    {"id":"39854","name":"Antithrombin iii: List of nationally authorised medicinal products - PSUSA/00003159/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-10T19:00:00Z","last_updated_date":"2018-08-14T13:24:05Z","reference_number":"EMA/537207/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/antithrombin-iii-list-nationally-authorised-medicinal-products-psusa00003159201712_en.pdf"},
    {"id":"39855","name":"Standard operating procedure for co-ordination of pharmacovigilance inspections","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-09-28T12:00:00Z","last_updated_date":"2012-09-28T12:00:00Z","reference_number":"SOP/INSP/2045","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-co-ordination-pharmacovigilance-inspections_en.pdf"},
    {"id":"39856","name":"Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies with tracked changes (Rev. 2)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-08-08T17:00:00Z","last_updated_date":"2016-08-08T17:00:00Z","reference_number":"EMA/813938/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-tracked-changes-rev-2_en.pdf"},
    {"id":"39858","name":"European Medicines Agency practical guidance on the application form for centralised type IA and IB variations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-18T16:30:00Z","last_updated_date":"2023-06-14T11:38:00Z","reference_number":"EMA/233564/2014 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-practical-guidance-application-form-centralised-type-ia-and-ib-variations_en.pdf"},
    {"id":"39859","name":"Etoposide: List of nationally authorised medicinal products -       PSUSA/00001333/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-13T18:51:00Z","last_updated_date":"2018-04-13T18:56:33Z","reference_number":"EMA/231687/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/etoposide-list-nationally-authorised-medicinal-products-psusa00001333201708_en.pdf"},
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    {"id":"39861","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Adcetris (brentuximab vedotin) for the treatment of anaplastic large cell lymphoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2012-11-28T16:00:00Z","last_updated_date":"2012-11-28T16:00:00Z","reference_number":"EMA/COMP/601842/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-adcetris-brentuximab-vedotin-treatment-anaplastic-large-cell-lymphoma_en.pdf"},
    {"id":"39862","name":"Synjardy Article-20 procedure - Annex I - III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-18T02:00:00Z","last_updated_date":"2016-05-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/synjardy-article-20-procedure-annex-i-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/synjardy-article-20-procedure-annex-i-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/synjardy-article-20-procedure-annex-i-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/synjardy-article-20-procedure-annex-i-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/synjardy-article-20-procedure-annex-i-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/synjardy-article-20-procedure-annex-i-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/synjardy-article-20-procedure-annex-i-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/synjardy-article-20-procedure-annex-i-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/synjardy-article-20-procedure-annex-i-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/synjardy-article-20-procedure-annex-i-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/synjardy-article-20-procedure-annex-i-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/synjardy-article-20-procedure-annex-i-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/synjardy-article-20-procedure-annex-i-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/synjardy-article-20-procedure-annex-i-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/synjardy-article-20-procedure-annex-i-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/synjardy-article-20-procedure-annex-i-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/synjardy-article-20-procedure-annex-i-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/synjardy-article-20-procedure-annex-i-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/synjardy-article-20-procedure-annex-i-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/synjardy-article-20-procedure-annex-i-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/synjardy-article-20-procedure-annex-i-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/synjardy-article-20-procedure-annex-i-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/synjardy-article-20-procedure-annex-i-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/synjardy-article-20-procedure-annex-i-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/synjardy-article-20-procedure-annex-i-iii_no.pdf"}},
    {"id":"39867","name":"Presentation - Development of drugs for resistant organisms","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:49Z","last_updated_date":"2011-04-26T18:05:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-resistant-organisms_en.pdf"},
    {"id":"39870","name":"Draft list of references supporting the assessment of Arnica montana L., flos","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2013-08-22T02:00:00Z","last_updated_date":"2013-08-22T02:00:00Z","reference_number":"EMA/HMPC/198792/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-arnica-montana-l-flos_en.pdf"},
    {"id":"39871","name":"Withdrawal assessment report for Ogivri","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-11-28T01:00:00Z","last_updated_date":"2017-11-28T01:00:00Z","reference_number":"EMA/305022/2017","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ogivri_en.pdf"},
    {"id":"39872","name":"Minutes of the 65th meeting of the Management Board: 10 December 2009","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2010-04-07T02:00:00Z","last_updated_date":"2010-04-07T02:00:00Z","reference_number":"EMA/MB/806136/2009","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-65th-meeting-management-board-10-december-2009_sv.pdf"}},
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    {"id":"39876","name":"CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2014-11-21T01:00:00Z","reference_number":"EMA/709243/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_bg.pdf","es":"https://www.ema.europa.eu/es/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_cs.pdf","da":"https://www.ema.europa.eu/da/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_da.pdf","de":"https://www.ema.europa.eu/de/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_de.pdf","et":"https://www.ema.europa.eu/et/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_et.pdf","el":"https://www.ema.europa.eu/el/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_hr.pdf","it":"https://www.ema.europa.eu/it/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/press-release/cmdh-agrees-strengthen-warnings-use-valproate-medicines-women-and-girls_sv.pdf"}},
    {"id":"39877","name":"Calendula Flower: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2018-07-02T02:00:00Z","last_updated_date":"2018-07-02T02:00:00Z","reference_number":"EMA/267467/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/calendula-flower-summary-public_en.pdf"},
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    {"id":"39888","name":"Cyclodextrins used as excipients - Report published in support of the ‘Questions and answers on cyclodextrins used as excipients in medicinal products for human use’","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"EMA/CHMP/333892/2013","document_url":"https://www.ema.europa.eu/en/documents/report/cyclodextrins-used-excipients-report-published-support-questions-and-answers-cyclodextrins-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"39890","name":"Open Invitation to Tender, EMEA/2006/35/ACC, Banking services for EMEA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-08-29T02:00:00Z","last_updated_date":"2006-08-29T02:00:00Z","reference_number":"EMEA/3525/04/5736","document_url":"https://www.ema.europa.eu/en/documents/other/open-invitation-tender-emea200635acc-banking-services-emea_en.pdf"},
    {"id":"39893","name":"EU/3/07/484: Public summary of positive opinion for orphan designation of adenovirus associated viral vector serotype 4 containing the human RPE65 gene for treatment of Leber's congenital amaurosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-01-22T01:00:00Z","last_updated_date":"2015-05-27T02:00:00Z","reference_number":"EMEA/COMP/440649/2007 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu307484-public-summary-positive-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-4-containing-human-rpe65-gene-treatment-lebers-congenital-amaurosis_en.pdf"},
    {"id":"39897","name":"Reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-03-13T14:00:00Z","last_updated_date":"2013-03-21T18:00:00Z","reference_number":"EMA/CHMP/806058/2009/Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-requirements-intravenous-liposomal-products-developed-reference-innovator-liposomal-product-revision-2_en.pdf"},
    {"id":"39898","name":"Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-14T01:00:00Z","last_updated_date":"2016-10-18T12:21:24Z","reference_number":"EMA/172345/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/milnacipran-list-nationally-authorised-medicinal-products-psusa00002063201504_en.pdf"},
    {"id":"39899","name":"Cinnamomi ceylanici cortex: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/713/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/cinnamomi-ceylanici-cortex-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39901","name":"Hearing AESGP during MLWP May 2010 meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/HMPC/300059/2010","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-aesgp-during-mlwp-may-2010-meeting_en.pdf"},
    {"id":"39902","name":"EU/3/14/1241: Public summary of opinion on orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-04-01T16:00:00Z","last_updated_date":"2014-04-01T16:00:00Z","reference_number":"EMA/COMP/29754/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141241-public-summary-opinion-orphan-designation-asp-arg-val-tyr-ile-his-pro-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"39904","name":"Public statement on Monotard (insulin human (rDNA)): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2007-08-24T14:09:21Z","last_updated_date":"2010-02-11T21:21:54Z","reference_number":"EMEA/367921/2007","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-monotard-insulin-human-rdna-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"39905","name":"EU/3/16/1665: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector containing the human RPGR gene for the treatment of retinitis pigmentosa caused by mutations in the RPGR gene","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-06-22T02:00:00Z","last_updated_date":"2016-06-22T02:00:00Z","reference_number":"EMA/COMP/314134/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161665-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-containing-human-rpgr-gene-treatment-retinitis-pigmentosa-caused-mutations-rpgr-gene_en.pdf"},
    {"id":"39906","name":"Presentation - Case study: Application of health based exposure limits in a cleaning validation (A. Engwicht-Lassmann, IFAH)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-application-health-based-exposure-limits-cleaning-validation-engwicht-lassmann-ifah_en.pdf"},
    {"id":"39907","name":"CHMP post-authorisation summary of positive opinion for Epoetin alfa Hexal on 23 October 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-10-23T02:09:21Z","last_updated_date":"2008-10-23T02:09:21Z","reference_number":"EMEA/CHMP/567074/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-epoetin-alfa-hexal-23-october-2008_en.pdf"},
    {"id":"39909","name":"Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-03-21T17:00:00Z","last_updated_date":"2013-03-21T17:00:00Z","reference_number":"EMA/CVMP/205176/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-eprinomectin_en.pdf-2"},
    {"id":"39910","name":"Presentation - What should be the source data when considering a paediatric development (S. Cole)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-09T01:00:00Z","last_updated_date":"2015-12-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-should-be-source-data-when-considering-paediatric-development-s-cole_en.pdf"},
    {"id":"39911","name":"Presentation - Study design and conduct efficiency evaluation via discrete event simulation: Applications in paediatric oncology","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-13T02:09:21Z","last_updated_date":"2008-04-13T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-study-design-and-conduct-efficiency-evaluation-discrete-event-simulation-applications-paediatric-oncology_en.pdf"},
    {"id":"39912","name":"Presentation - EMA/FDA/Health Canada workshop on paediatric pulmonary arterial hypertension","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-06-20T02:00:00Z","last_updated_date":"2017-06-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emafdahealth-canada-workshop-paediatric-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"39914","name":"Presentation - Critical review of outcomes used in MS clinical trials (George Ebers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-11-12T01:00:00Z","last_updated_date":"2013-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-critical-review-outcomes-used-ms-clinical-trials-george-ebers_en.pdf"},
    {"id":"39917","name":"Meeting highlights from Paediatric Committee : 11 - 13 November 2009","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-11-24T01:00:00Z","last_updated_date":"2009-11-24T01:00:00Z","reference_number":"http://www.emea.europa.eu/pdfs/human/pdco/71641309","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-11-13-november-2009_en.pdf"},
    {"id":"39918","name":"CHMP post-authorisation summary of positive opinion for Keytruda (II-0014)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T13:00:00Z","last_updated_date":"2017-03-24T13:00:00Z","reference_number":"EMA/CHMP/162113/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-0014_en.pdf"},
    {"id":"39920","name":"Presentation - Development of drugs for eradication of carriage","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-04-26T18:05:45Z","last_updated_date":"2011-04-26T18:05:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-development-drugs-eradication-carriage_en.pdf"},
    {"id":"39921","name":"Opinions on safety variations / periodic safety update reports adopted at the CHMP meeting 17-20 March 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-03-24T17:00:00Z","last_updated_date":"2014-03-24T17:00:00Z","reference_number":"EMA/CHMP/123245/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-periodic-safety-update-reports-adopted-chmp-meeting-17-20-march-2014_en.pdf"},
    {"id":"39922","name":"Presentation - Session 4.3: Feedback from EC/EMA-FDA bilateral on paediatric research (Peter Karolyi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-43-feedback-ecema-fda-bilateral-paediatric-research-peter-karolyi_en.pdf"},
    {"id":"39924","name":"Lobaria pulmonaria: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:00:00Z","last_updated_date":"1999-08-01T02:00:00Z","reference_number":"EMEA/MRL/672/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/lobaria-pulmonaria-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"39926","name":"Opinion of the CVMP on the establishment of maximum residue limits: Pegylated bovine granulocyte colony stimulating factor","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T17:12:00Z","last_updated_date":"2012-05-25T17:12:00Z","reference_number":"EMA/CVMP/293093/2011","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-pegylated-bovine-granulocyte-colony-stimulating-factor_en.pdf"},
    {"id":"39928","name":"Presentation - Topic 2 - Endpoints that may correlate with cure (Gerry Davies)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-03-16T01:00:00Z","last_updated_date":"2017-03-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-topic-2-endpoints-may-correlate-cure-gerry-davies_en.pdf"},
    {"id":"39930","name":"Concept paper for the preparation of a reflection paper on meticillin-resistant Staphylococcus (pseud)intermedius","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-07-20T02:00:00Z","last_updated_date":"2009-07-20T02:00:00Z","reference_number":"EMEA/CVMP/SAGAM/386369/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-preparation-reflection-paper-meticillin-resistant-staphylococcus-pseudintermedius_en.pdf"},
    {"id":"39932","name":"Human medicines highlights - March 2013","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T11:00:00Z","last_updated_date":"2013-04-08T11:00:00Z","reference_number":"Issue 50","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-march-2013_en.pdf"},
    {"id":"39934","name":"Presentation - RMS and OMS - Industry on-boarding to SPOR (Kepa Amutxastegi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-20T17:00:00Z","last_updated_date":"2017-12-20T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rms-and-oms-industry-boarding-spor-kepa-amutxastegi_en.pdf"},
    {"id":"39939","name":"EU/3/13/1210: Public summary of opinion on orphan designation: Recombinant human parathyroid hormone for the treatment of hypoparathyroidism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-01-23T01:00:00Z","last_updated_date":"2015-06-08T02:00:00Z","reference_number":"EMA/COMP/712586/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131210-public-summary-opinion-orphan-designation-recombinant-human-parathyroid-hormone-treatment-hypoparathyroidism_en.pdf"},
    {"id":"39941","name":"CHMP post-authorisation summary of positive opinion for Humira","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/365477/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-humira_en.pdf-10"},
    {"id":"39942","name":"Concept paper on conduct of pharmacovigilance for medicines used children","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2002-10-17T02:00:00Z","last_updated_date":"2002-10-17T02:00:00Z","reference_number":"CPMP/PhVWP/4838/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-conduct-pharmacovigilance-medicines-used-children_en.pdf"},
    {"id":"39945","name":"EMA Management Board: highlights of December 2014 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-19T01:00:00Z","last_updated_date":"2014-12-19T01:00:00Z","reference_number":"EMA/790130/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-december-2014-meeting_en.pdf"},
    {"id":"39946","name":"EU/3/17/1856: Public summary of opinion on orphan designation: Inebilizumab for the treatment of neuromyelitis optica spectrum disorders","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-05-05T02:00:00Z","last_updated_date":"2022-05-19T02:00:00Z","reference_number":"EMA/144977/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171856-public-summary-opinion-orphan-designation-inebilizumab-treatment-neuromyelitis-optica-spectrum-disorders_en.pdf"},
    {"id":"39948","name":"European Medicines Agency appoints new Head of Unit for Veterinary\n\nmedicines and inspections","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-11-24T01:00:00Z","last_updated_date":"2005-11-24T01:00:00Z","reference_number":"EMEA/384622/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-appoints-new-head-unit-veterinary-medicines-and-inspections_en.pdf"},
    {"id":"39950","name":"Final list of references supporting the assessment of Commiphora molmol Engler, gummi-resina","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-12-22T15:00:00Z","last_updated_date":"2011-12-22T15:00:00Z","reference_number":"EMA/HMPC/16634/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"39953","name":"Scientific recommendation on classification of advanced therapy medicinal products: autologous engineered anti-CD19 Chimeric Antigen Receptor (CAR+) T-cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-03-22T12:00:00Z","last_updated_date":"2016-03-22T12:00:00Z","reference_number":"EMA/204251/2016","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-engineered-anti-cd19-chimeric-antigen-receptor-car-t-cells_en.pdf"},
    {"id":"39954","name":"C(2004) 356/3: Public summary of negative opinion for orphan designation of midazolam hydrochloride (for oromucosal use) for the treatment of seizures which continue for at least five minutes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-12-12T01:00:00Z","last_updated_date":"2005-12-12T01:00:00Z","reference_number":"EMEA/COMP/85/2004","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/c2004-3563-public-summary-negative-opinion-orphan-designation-midazolam-hydrochloride-oromucosal-use-treatment-seizures-which-continue-least-five-minutes_en.pdf"},
    {"id":"39955","name":"Presentation - Completion of the development of a formulation: Requirements for compliance check vs. requirements for Marketing Authorisation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-10-05T02:00:00Z","last_updated_date":"2010-10-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-completion-development-formulation-requirements-compliance-check-vs-requirements-marketing-authorisation_en.pdf-0"},
    {"id":"39956","name":"CHMP post-authorisation summary of positive opinion for Twynsta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T02:00:00Z","last_updated_date":"2013-04-26T02:00:00Z","reference_number":"EMA/CHMP/261191/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-twynsta_en.pdf"},
    {"id":"39959","name":"CHMP summary of positive opinion for Cresemba","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T02:00:00Z","last_updated_date":"2015-07-24T02:00:00Z","reference_number":"EMA/CHMP/470149/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cresemba_en.pdf"},
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    {"id":"39962","name":"Presentation - Crisis management – Case studies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-crisis-management-case-studies_en.pdf"},
    {"id":"39963","name":"CHMP summary of positive opinion for Rasagiline ratiopharm","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-11-21T01:00:00Z","last_updated_date":"2014-11-21T01:00:00Z","reference_number":"EMA/CHMP/693590/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rasagiline-ratiopharm_en.pdf"},
    {"id":"39964","name":"Presentation - Healthcare Professionals’ Organisations (HCPWP) feedback from CHMP - EMA's PCWP and HCPWP joint meeting (Fà¡tima Ventura)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-healthcare-professionals-organisations-hcpwp-feedback-chmp-emas-pcwp-and-hcpwp-joint-meeting-fatima-ventura_en.pdf"},
    {"id":"39965","name":"European Agency for the Evaluation of Medicinal Products: Committee for Proprietary Medicinal Products - Meeting of 15 to 17 January 2002","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2002-01-17T01:00:00Z","last_updated_date":"2002-01-17T01:00:00Z","reference_number":"EMEA/CPMP/4025/02","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-agency-evaluation-medicinal-products-committee-proprietary-medicinal-products-meeting-15-17-january-2002_en.pdf"},
    {"id":"39967","name":"Presentation - Application of ICH Q12 tools and enablers: Lifecycle strategy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-17T01:00:00Z","last_updated_date":"2015-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-application-ich-q12-tools-and-enablers-lifecycle-strategy_en.pdf"},
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    {"id":"39971","name":"European Medicines Agency to review the safety of somatropin-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-10T01:00:00Z","last_updated_date":"2010-12-10T01:00:00Z","reference_number":"EMA/804468/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-review-safety-somatropin-containing-medicines_en.pdf"},
    {"id":"39974","name":"EU/3/14/1325: Public summary of opinion on orphan designation: Obinutuzumab for the treatment of diffuse large B-cell lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/452142/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141325-public-summary-opinion-orphan-designation-obinutuzumab-treatment-diffuse-large-b-cell-lymphoma_en.pdf"},
    {"id":"39977","name":"Guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-08T12:50:00Z","last_updated_date":"2016-07-08T12:50:00Z","reference_number":"EMA/CHMP/748108/2013 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders-revision-3_en.pdf"},
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    {"id":"39980","name":"Fraud reporting process and reporting template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-03-22T10:58:00Z","last_updated_date":"2017-03-22T10:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/fraud-reporting-process-and-reporting-template_en.pdf"},
    {"id":"39981","name":"Opinion following an Article 6(12) referral Octegra and associated names International Non-Proprietary Name (INN): moxifloxacin: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-08-14T02:08:21Z","last_updated_date":"2008-08-14T02:08:21Z","reference_number":"EMEA/CHMP/524284/2008","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-612-referral-octegra-and-associated-names-international-non-proprietary-name-inn-moxifloxacin-background-information_sv.pdf"}},
    {"id":"39982","name":"ICH guideline Q4B Annex 10 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis - general chapter - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T01:00:00Z","last_updated_date":"2017-07-13T16:30:00Z","reference_number":"EMEA/CHMP/ICH/381133/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-10-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-polyacrylamide-gel-electrophoresis-general-chapter-step-5_en.pdf"},
    {"id":"39985","name":"Questions and answers on refusal of the marketing authorisation for Masican","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/167920/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-masican_sv.pdf"}},
    {"id":"39986","name":"Guidance on parallel EMA / EUnetHTA 21 Joint Scientific Consultation","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-07-04T11:00:00Z","last_updated_date":"2022-10-06T13:04:00Z","reference_number":"EMA/410962/2017 Rev. 7","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-parallel-ema-eunethta-21-joint-scientific-consultation_en.pdf"},
    {"id":"39988","name":"EU/3/02/090: Public summary of positive opinion for orphan designation of human transferrin conjugated to mutant diphtheria toxin for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T01:00:00Z","last_updated_date":"2007-12-04T01:00:00Z","reference_number":"EMEA/COMP/49/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302090-public-summary-positive-opinion-orphan-designation-human-transferrin-conjugated-mutant-diphtheria-toxin-treatment-glioma_en.pdf"},
    {"id":"39989","name":"Presentation - Challenging patients on DOACs and need for monitoring (Menno Huisman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenging-patients-doacs-and-need-monitoring-menno-huisman_en.pdf"},
    {"id":"39990","name":"PDCO monthly report of opinions on paediatric investigation plans: 14-16 May 2012","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-05-25T16:30:00Z","last_updated_date":"2012-05-25T16:30:00Z","reference_number":"EMA/PDCO/307494/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-14-16-may-2012_en.pdf"},
    {"id":"39991","name":"Diclofenac Article-31 referral - New safety advice for diclofenac – CMDh endorses PRAC recommendation","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-06-28T02:00:00Z","last_updated_date":"2013-06-28T02:00:00Z","reference_number":"EMA/380947/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-new-safety-advice-diclofenac-cmdh-endorses-prac-recommendation_en.pdf"},
    {"id":"39992","name":"Presentation - Agenda point 6: RONAFA report (Helen Jukes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-03T02:00:00Z","last_updated_date":"2017-04-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agenda-point-6-ronafa-report-helen-jukes_en.pdf"},
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    {"id":"39998","name":"Guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication with tracked changes (Rev. 1)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-10-12T12:30:00Z","last_updated_date":"2017-10-12T12:30:00Z","reference_number":"EMA/118465/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xv-safety-communication-tracked-changes-rev-1_en.pdf"},
    {"id":"40003","name":"Reflection paper on the use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-12-03T10:55:00Z","last_updated_date":"2013-12-03T10:55:00Z","reference_number":"EMA/HMPC/453258/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-recoveredrecycled-solvents-manufacture-herbal-preparations-use-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"40004","name":"Final European Union herbal monograph on Olea europaea L., folium - First version","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T01:00:00Z","last_updated_date":"2018-01-04T01:00:00Z","reference_number":"EMA/HMPC/359238/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-olea-europaea-l-folium-first-version_en.pdf"},
    {"id":"40007","name":"EU/3/09/690: Public summary of positive opinion for orphan designation of human anthrax immunoglobulin for the post-exposure prophylaxis of inhalation anthrax disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-11-18T00:09:21Z","last_updated_date":"2016-08-12T01:09:21Z","reference_number":"EMEA/COMP/577283/2009","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309690-public-summary-positive-opinion-orphan-designation-human-anthrax-immunoglobulin-post-exposure-prophylaxis-inhalation-anthrax-disease_en.pdf"},
    {"id":"40008","name":"Reflection paper on classification of advanced therapy medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-06-08T16:20:00Z","last_updated_date":"2015-06-08T16:20:00Z","reference_number":"EMA/CAT/600280/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-classification-advanced-therapy-medicinal-products_en.pdf-0"},
    {"id":"40012","name":"New EMEA transparency policy measures","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2003-10-31T01:00:00Z","last_updated_date":"2003-10-31T01:00:00Z","reference_number":"EMEA/MB/52/03/Rev 1/Final","document_url":"https://www.ema.europa.eu/en/documents/other/new-emea-transparency-policy-measures_en.pdf"},
    {"id":"40015","name":"GVK Biosciences Article-31 referral - GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T13:00:00Z","last_updated_date":"2015-02-27T13:00:00Z","reference_number":"EMA/37763/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/gvk-biosciences-article-31-referral-gvk-biosciences-european-medicines-agency-recommends-suspending-medicines-over-flawed-studies_en.pdf"},
    {"id":"40016","name":"Zinbryta Article-20 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-06-09T18:00:00Z","last_updated_date":"2017-06-09T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-notification_en.pdf"},
    {"id":"40017","name":"EU/3/05/343: Public summary of positive opinion for orphan designation of enzastaurin hydrochloride for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2006-08-08T02:00:00Z","last_updated_date":"2006-08-08T02:00:00Z","reference_number":"EMEA/COMP/383664/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305343-public-summary-positive-opinion-orphan-designation-enzastaurin-hydrochloride-treatment-glioma_en.pdf"},
    {"id":"40018","name":"CHMP post-authorisation summary of positive opinion for Sebivo","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2021-01-14T01:00:00Z","reference_number":"EMA/CHMP/123824/2012","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sebivo_en.pdf"},
    {"id":"40020","name":"Questions and answers on Article 20 non-pharmacovigilance procedures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-07-06T18:00:00Z","last_updated_date":"2016-07-06T18:00:00Z","reference_number":"EMA/457260/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-article-20-non-pharmacovigilance-procedures_en.pdf"},
    {"id":"40022","name":"Presentation - Session 2.8: Examples of interactions - ECFS (Tim Lee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-22T02:00:00Z","last_updated_date":"2017-05-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-28-examples-interactions-ecfs-tim-lee_en.pdf"},
    {"id":"40023","name":"Draft community herbal monograph on Echinacea pallida Nutt., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-09-04T02:09:21Z","last_updated_date":"2008-09-04T02:09:21Z","reference_number":"EMEA/HMPC/332350/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-echinacea-pallida-nutt-radix_en.pdf"},
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    {"id":"40027","name":"Divergent position on a revised CVMP opinion on an Article 35 referral of Directive 2001/82/EC for All long acting formulations for injection containing barium selenate for all food producing species","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-27T02:00:00Z","last_updated_date":"2014-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-revised-cvmp-opinion-article-35-referral-directive-200182ec-all-long-acting-formulations-injection-containing-barium-selenate-all-food-producing-species_en.pdf"},
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    {"id":"40029","name":"Opinion of the Committee for proprietary medicinal products pursuant to Article 10 of Directive 75/319/EEC as amended","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"1998-08-03T02:08:21Z","last_updated_date":"1998-08-03T02:08:21Z","reference_number":"CPMP/343/96","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-committee-proprietary-medicinal-products-pursuant-article-10-directive-75319eec-amended_en.pdf"},
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    {"id":"40033","name":"EU/3/14/1318: Public summary of opinion on orphan designation: Ulinastatin for the treatment of acute pancreatitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2014-10-01T02:00:00Z","reference_number":"EMA/COMP/443087/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141318-public-summary-opinion-orphan-designation-ulinastatin-treatment-acute-pancreatitis_en.pdf"},
    {"id":"40034","name":"Metformin Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T01:00:00Z","last_updated_date":"2016-12-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metformin-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metformin-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metformin-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metformin-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metformin-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metformin-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metformin-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metformin-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metformin-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metformin-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metformin-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metformin-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metformin-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metformin-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metformin-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metformin-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metformin-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metformin-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metformin-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metformin-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metformin-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metformin-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metformin-article-31-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/metformin-article-31-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/metformin-article-31-referral-annex-iii_no.pdf"}},
    {"id":"40035","name":"Presentation and Analysis of the EFPIA questionnaire 06/08 on the centralised procedure new applications David Jefferys - Eisai","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-02-24T00:09:21Z","last_updated_date":"2009-02-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-and-analysis-efpia-questionnaire-0608-centralised-procedure-new-applications-david-jefferys-eisai_en.pdf"},
    {"id":"40041","name":"Work plan for the CVMP Immunologicals Working Party 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-12-19T15:30:00Z","last_updated_date":"2018-04-30T13:47:00Z","reference_number":"EMA/CVMP/IWP/347865/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-cvmp-immunologicals-working-party-2018_en.pdf"},
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    {"id":"40044","name":"Final overview of comments received on European Union herbal monograph on Althaea officinalis L., radix (EMA/HMPC/436679/2015)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2016-11-04T15:12:00Z","last_updated_date":"2016-11-04T15:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/final-overview-comments-received-european-union-herbal-monograph-althaea-officinalis-l-radix-emahmpc4366792015_en.pdf"},
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    {"id":"40047","name":"Meloxicam (Modification for bovine): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-07-01T02:00:00Z","last_updated_date":"1999-07-01T02:00:00Z","reference_number":"EMEA/MRL/634/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/meloxicam-modification-bovine-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40049","name":"Public statement on Nivolumab BMS: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-01-14T01:00:00Z","last_updated_date":"2016-01-14T01:00:00Z","reference_number":"EMA/6927/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-nivolumab-bms-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"40050","name":"Opinions on safety variations adopted at the CHMP meeting of 16-19 April 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-04-23T02:00:00Z","last_updated_date":"2012-04-23T02:00:00Z","reference_number":"EMA/CHMP/213035/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-safety-variations-adopted-chmp-meeting-16-19-april-2012_en.pdf"},
    {"id":"40051","name":"Assessment report for metoclopramide-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T01:00:00Z","last_updated_date":"2014-01-31T01:00:00Z","reference_number":"EMA/753989/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/assessment-report-metoclopramide-containing-medicines_en.pdf"},
    {"id":"40052","name":"European Court of Auditors final report on the annual accounts of the European Medicines Agency for the financial year 2008","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-11-24T00:09:21Z","last_updated_date":"2009-11-24T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-court-auditors-final-report-annual-accounts-european-medicines-agency-financial-year-2008_en.pdf"},
    {"id":"40053","name":"Presentation - Personalised medicines: what does experience tell us so far? - Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) joint workshop on personalised medicines (Ro...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-17T02:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-personalised-medicines-what-does-experience-tell-us-so-far-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-joint-workshop-personalised-medicines_en.pdf"},
    {"id":"40054","name":"News bulletin for small and medium-sized enterprises - Issue 3","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2008-02-01T01:00:00Z","last_updated_date":"2008-02-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-3_en.pdf"},
    {"id":"40055","name":"Withdrawal letter: Kepnetic","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T13:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-kepnetic_en.pdf"},
    {"id":"40056","name":"Tetrazepam-containing medicines - Article-107i procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-01-11T13:00:00Z","last_updated_date":"2013-01-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tetrazepam-containing-medicines-article-107i-procedure-notification_en.pdf"},
    {"id":"40057","name":"EU/3/13/1120: Public summary of opinion on orphan designation: 4-[2-(6-methylpyridin-2-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazol-3-yl]-quinoline-6-carboxamide monohydrate for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-05-14T12:00:00Z","last_updated_date":"2013-05-14T12:00:00Z","reference_number":"EMA/COMP/175329/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131120-public-summary-opinion-orphan-designation-4-2-6-methylpyridin-2-yl-56-dihydro-4h-pyrrolo12-bpyrazol-3-yl-quinoline-6-carboxamide-monohydrate-treatment-glioma_en.pdf"},
    {"id":"40058","name":"The use of in vitro and in vivo data to define both design space and control strategy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-09-28T02:09:21Z","last_updated_date":"2009-09-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/use-vitro-and-vivo-data-define-both-design-space-and-control-strategy_en.pdf"},
    {"id":"40059","name":"CHMP summary of positive opinion for Ulipristal Acetate Gedeon Richter","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2018-06-29T02:00:00Z","reference_number":"EMA/CHMP/417636/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ulipristal-acetate-gedeon-richter_en.pdf"},
    {"id":"40060","name":"CHMP positive summary of opinion for Sycrest","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2010-06-25T02:00:00Z","reference_number":"EMA/CHMP/397789/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-sycrest_en.pdf"},
    {"id":"40063","name":"Presentation - Case Study 6 - Novo Nordisk experience in the application of QbD","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-6-novo-nordisk-experience-application-qbd_en.pdf"},
    {"id":"40065","name":"Marketing authorisation holder electronic reaction monitoring report example","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-02T18:10:00Z","last_updated_date":"2017-09-25T12:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/marketing-authorisation-holder-electronic-reaction-monitoring-report-example_en.xlsx"},
    {"id":"40067","name":"CHMP summary of positive opinion for Potactasol","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-10-22T02:00:00Z","last_updated_date":"2010-10-22T02:00:00Z","reference_number":"EMA/643392/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-potactasol_en.pdf"},
    {"id":"40069","name":"Withdrawal assessment report for Exelon and Prometax","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-02-18T01:00:00Z","last_updated_date":"2014-02-18T01:00:00Z","reference_number":"EMA/81748/2014","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-exelon-and-prometax_en.pdf-0"},
    {"id":"40070","name":"Committee for medicinal products for veterinary use -\n\nEMEA public bulletin 2003 on veterinary pharmacovigilance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2005-03-19T01:00:00Z","last_updated_date":"2005-03-19T01:00:00Z","reference_number":"EMEA/CVMP/359/074","document_url":"https://www.ema.europa.eu/en/documents/other/committee-medicinal-products-veterinary-use-emea-public-bulletin-2003-veterinary-pharmacovigilance_en.pdf"},
    {"id":"40071","name":"Presentation - Evaluation of the European Medicines Agency (EMA): Findings, conclusions and recommendations","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evaluation-european-medicines-agency-ema-findings-conclusions-and-recommendations_en.pdf"},
    {"id":"40072","name":"Presentation - Specialist nurses and antimicrobial resistance (AMR): The inclusion of specialist nursing workforce on AMR- Session 4 (Ber Oomen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-specialist-nurses-and-antimicrobial-resistance-amr-inclusion-specialist-nursing-workforce-amr-session-4-ber-oomen_en.pdf"},
    {"id":"40075","name":"Assessment of the paediatric needs - Gastroenterology","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2007-10-01T02:00:00Z","last_updated_date":"2007-10-01T02:00:00Z","reference_number":"EMEA/527934/2007","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-paediatric-needs-gastroenterology_en.pdf"},
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    {"id":"40079","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 11-13 November 2015","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-11-25T14:35:00Z","last_updated_date":"2015-11-25T14:35:00Z","reference_number":"EMA/PDCO/723182/2015","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-11-13-november-2015_en.pdf"},
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    {"id":"40208","name":"Classification and analysis of the good clinical practice (GCP) inspection findings of GCP inspections conducted at the request of CHMP","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-08T16:10:00Z","last_updated_date":"2014-12-08T16:10:00Z","reference_number":"INS/GCP/46309/2012","document_url":"https://www.ema.europa.eu/en/documents/other/classification-and-analysis-good-clinical-practice-gcp-inspection-findings-gcp-inspections-conducted-request-chmp_en.pdf"},
    {"id":"40209","name":"CHMP post-authorisation summary of positive opinion for Orkambi (X-20)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-11-10T13:00:00Z","last_updated_date":"2017-11-10T13:00:00Z","reference_number":"EMA/738556/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-orkambi-x-20_en.pdf"},
    {"id":"40210","name":"European Medicines Agency concludes action on COX-2 inhibitors","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-06-27T02:00:00Z","last_updated_date":"2005-06-27T02:00:00Z","reference_number":"EMEA/207766/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-concludes-action-cox-2-inhibitors_en.pdf"},
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    {"id":"40214","name":"First monoclonal antibody therapy for prevention of migraine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T14:00:00Z","last_updated_date":"2018-06-01T14:00:00Z","reference_number":"EMA/366426/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-monoclonal-antibody-therapy-prevention-migraine_en.pdf"},
    {"id":"40215","name":"EU/3/13/1208: Public summary of opinion on orphan designation: Soraprazan for the treatment of Stargardt’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-12-02T01:00:00Z","last_updated_date":"2013-12-02T01:00:00Z","reference_number":"EMA/COMP/631348/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131208-public-summary-opinion-orphan-designation-soraprazan-treatment-stargardts-disease_en.pdf"},
    {"id":"40217","name":"Questions and answers on Protopic/protopy and Elidel","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2006-03-23T00:08:21Z","last_updated_date":"2006-03-23T00:08:21Z","reference_number":"EMEA/CHMP/80270/2006","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-protopicprotopy-and-elidel_en.pdf"},
    {"id":"40220","name":"Presentation - MEA assays using human iPSC-derived cardiomyocytes, challenges and opportunities (T. de Korte)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-15T11:02:00Z","last_updated_date":"2017-11-15T11:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mea-assays-using-human-ipsc-derived-cardiomyocytes-challenges-and-opportunities-t-de-korte_en.pdf"},
    {"id":"40223","name":"Concept paper for use of data in EudraVigilance veterinary","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-06-26T02:00:00Z","last_updated_date":"2006-06-26T02:00:00Z","reference_number":"EMEA/CVMP/68614/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-use-data-eudravigilance-veterinary_en.pdf"},
    {"id":"40226","name":"Zinbryta Article-20 procedure - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T11:00:00Z","last_updated_date":"2018-03-02T11:00:00Z","reference_number":"EMA/120379/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-procedure-review-started_en.pdf"},
    {"id":"40228","name":"ICH: E 5 (R1): Questions & answers ethnic factors in the acceptability of foreign clinical data","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2006-06-01T02:00:00Z","last_updated_date":"2006-06-01T02:00:00Z","reference_number":"CPMP/ICH/5746/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-5-r1-questions-answers-ethnic-factors-acceptability-foreign-clinical-data_en.pdf"},
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    {"id":"40240","name":"EU/3/11/887: Public summary of opinion on orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt for the treatment of post-essential thrombocythaemia myel...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-08-16T02:00:00Z","last_updated_date":"2013-06-20T13:00:00Z","reference_number":"EMA/COMP/407852/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311887-public-summary-opinion-orphan-designation-n-cyanomethyl-4-2-4-morpholin-4-ylphenylaminopyrimidin-4-ylbenzamide-dihydrochloride-salt-treatment-post-essential-thrombocythaemia-myel_en.pdf"},
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    {"id":"40266","name":"EU/3/05/334: Public summary of positive opinion for orphan designation of human immunoglobulin G1 constant region - human ectodysplasin-A1 receptor-binding domain fusion protein for the treatment of X-linked hypohidrotic...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2007-12-04T01:00:00Z","last_updated_date":"2010-02-22T01:00:00Z","reference_number":"EMEA/COMP/367775/2005","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305334-public-summary-positive-opinion-orphan-designation-human-immunoglobulin-g1-constant-region-human-ectodysplasin-a1-receptor-binding-domain-fusion-protein-treatment-x-linked-hypohidrotic_en.pdf"},
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    {"id":"40269","name":"PRAC recommends suspension of diacerein-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-11-08T13:00:01Z","last_updated_date":"2013-11-08T13:00:01Z","reference_number":"EMA/679264/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-recommends-suspension-diacerein-containing-medicines_en.pdf"},
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    {"id":"40272","name":"Committee for medicinal products for veterinary use: Meeting of 16 to 18 May 2006","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2006-05-19T14:29:21Z","last_updated_date":"2006-05-19T14:29:21Z","reference_number":"EMEA/CVMP/165988/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-meeting-16-18-may-2006_en.pdf"},
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    {"id":"40281","name":"CVMP summary of positive opinion for Vectra 3D","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-10-11T02:00:00Z","last_updated_date":"2013-10-11T02:00:00Z","reference_number":"EMA/CVMP/569374/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vectra-3d_en.pdf"},
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    {"id":"40286","name":"Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T15:00:00Z","last_updated_date":"2016-10-28T15:00:00Z","reference_number":"EMA/719228/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00010298201603_en.pdf"},
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    {"id":"40394","name":"European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 January 2006","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-01-28T00:09:21Z","last_updated_date":"2006-01-28T00:09:21Z","reference_number":"EMEA/32796/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-committee-medicinal-products-human-use-23-26-january-2006_en.pdf"},
    {"id":"40395","name":"Draft assessment report on Solanum dulcamara L., stipites","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2012-05-10T02:00:00Z","last_updated_date":"2012-05-10T02:00:00Z","reference_number":"EMA/HMPC/734363/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-solanum-dulcamara-l-stipites_en.pdf"},
    {"id":"40397","name":"Reflection paper on use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"EMA/CVMP/AWP/721118/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-aminoglycosides-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"40398","name":"Passion flower: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-10-06T02:00:00Z","last_updated_date":"2016-10-06T02:00:00Z","reference_number":"EMA/275240/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/passion-flower-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/passion-flower-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/passion-flower-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/passion-flower-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/passion-flower-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/passion-flower-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/passion-flower-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/passion-flower-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/passion-flower-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/passion-flower-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/passion-flower-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/passion-flower-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/passion-flower-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/passion-flower-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/passion-flower-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/passion-flower-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/passion-flower-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/passion-flower-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/passion-flower-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/passion-flower-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/passion-flower-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/passion-flower-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/passion-flower-summary-public_sv.pdf"}},
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    {"id":"40415","name":"Agenda and list of speakers - Public Hearing: quinolone and fluoroquinolone medicines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-06-07T12:00:00Z","last_updated_date":"2018-06-11T18:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-list-speakers-public-hearing-quinolone-and-fluoroquinolone-medicines_en.pdf"},
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    {"id":"40431","name":"EU/3/10/845: Public summary of opinion on orphan designation: Dry extract from Birch bark (DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-04T01:00:00Z","last_updated_date":"2012-06-28T18:00:00Z","reference_number":"EMA/COMP/10735/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310845-public-summary-opinion-orphan-designation-dry-extract-birch-bark-der-01-021-extraction-solvent-n-heptane-95-vv-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"40432","name":"EMA restricts use of multiple sclerosis medicine Zinbryta","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-07-07T14:00:01Z","last_updated_date":"2017-07-07T14:00:01Z","reference_number":"EMA/424159/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-restricts-use-multiple-sclerosis-medicine-zinbryta_en.pdf"},
    {"id":"40433","name":"09 June 2009 minutes: Joint meeting with HCP and WG","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2009-06-09T02:00:00Z","last_updated_date":"2009-06-09T02:00:00Z","reference_number":"EMEA/358876/2009","document_url":"https://www.ema.europa.eu/en/documents/minutes/09-june-2009-minutes-joint-meeting-hcp-and-wg_en.pdf"},
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    {"id":"40451","name":"PRAC re-examines diacerein and recommends that it remain available with restrictions","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-03-07T13:00:00Z","last_updated_date":"2014-03-07T13:00:00Z","reference_number":"EMA/133894/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/prac-re-examines-diacerein-and-recommends-it-remain-available-restrictions_en.pdf"},
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    {"id":"40459","name":"EU/3/18/2025: Public summary of opinion on orphan designation: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles for the treatment of methylmalonic acidaemia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T18:30:00Z","last_updated_date":"2023-06-26T18:30:00Z","reference_number":"EMA/275363/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182025-public-summary-opinion-orphan-designation-modified-mrna-encoding-human-methylmalonyl-coenzyme-mutase-encapsulated-lipid-nanoparticles-treatment-methylmalonic-acidaemia_en.pdf"},
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    {"id":"40469","name":"New medicine for rare, chronic liver disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T14:00:01Z","last_updated_date":"2016-10-14T14:00:01Z","reference_number":"EMA/CHMP/666310/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-rare-chronic-liver-disease_en.pdf"},
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    {"id":"40474","name":"Reflection paper on the use of fluoroquinolones in food-producing animals - precautions for use in the summary of product characteristics regarding prudent-use guidance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2006-11-08T01:00:00Z","last_updated_date":"2006-11-08T01:00:00Z","reference_number":"EMEA/CVMP/416168/2006-FINAL","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-use-fluoroquinolones-food-producing-animals-precautions-use-summary-product-characteristics-regarding-prudent-use-guidance_en.pdf"},
    {"id":"40475","name":"Presentation - Indications and labelling - Specific aspects cross reference within the SmPC (K.Dunder, CHMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-indications-and-labelling-specific-aspects-cross-reference-within-smpc-kdunder-chmp_en.pdf"},
    {"id":"40476","name":"EU/3/13/1129: Public summary of opinion on orphan designation: Allogeneic bone-marrow-derived mesenchymal cells expanded ex vivo in synthetic media for the treatment of graft-versus-host disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2013-06-25T19:00:00Z","last_updated_date":"2013-07-09T11:00:00Z","reference_number":"EMA/COMP/268935/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131129-public-summary-opinion-orphan-designation-allogeneic-bone-marrow-derived-mesenchymal-cells-expanded-ex-vivo-synthetic-media-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"40477","name":"Agenda - CAT agenda of the 8-9 December 2016 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-12-08T18:00:00Z","last_updated_date":"2016-12-08T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-8-9-december-2016-meeting_en.pdf"},
    {"id":"40478","name":"Presentation - New pharmacovigilance legislation: Update on implementation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-pharmacovigilance-legislation-update-implementation_en.pdf"},
    {"id":"40480","name":"Uman Big - Article 29 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-03-21T00:08:21Z","last_updated_date":"2009-03-21T00:08:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/uman-big-article-29-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"40482","name":"Metronidazole / neomycin / nystatin: List of nationally authorised medicinal products - PSUSA/00010508/201709","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-05-23T20:00:00Z","last_updated_date":"2018-05-23T20:22:18Z","reference_number":"EMA/303477/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/metronidazole-neomycin-nystatin-list-nationally-authorised-medicinal-products-psusa00010508201709_en.pdf"},
    {"id":"40483","name":"Decision on amending budget No 1-2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-10-07T17:30:00Z","last_updated_date":"2016-10-07T17:30:00Z","reference_number":"EMA/MB/572210/2015","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-1-2016_en.pdf"},
    {"id":"40484","name":"European Medicines Agency announces plan to publish committee agendas and minutes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-07-18T20:14:39Z","last_updated_date":"2012-07-18T20:14:39Z","reference_number":"EMA/480386/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-announces-plan-publish-committee-agendas-and-minutes_en.pdf"},
    {"id":"40486","name":"Committee for Medicinal Products for Human Use (CHMP) - November 2007 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2009-10-27T00:00:00Z","last_updated_date":"2009-10-27T00:00:00Z","reference_number":"EMEA/522109/2007","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-november-2007-plenary-meeting-monthly-report_en.pdf"},
    {"id":"40487","name":"Technical Specifications - Annex II Exclusion criteria declaration: Procurement procedure EMA/2014/01/PH","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T01:00:00Z","last_updated_date":"2014-03-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specifications-annex-ii-exclusion-criteria-declaration-procurement-procedure-ema201401ph_en.pdf"},
    {"id":"40490","name":"Committee for Advanced Therapies (CAT) monthly report of application procedures, guidelines and related documents on advanced therapies:  April 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-04-27T12:30:00Z","last_updated_date":"2012-04-27T12:30:00Z","reference_number":"EMA/CAT/263109/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2012-meeting_en.pdf"},
    {"id":"40491","name":"EU/3/10/768: Public summary of opinion on orphan designation: 11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)] heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene for the treat...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-10-18T02:00:00Z","last_updated_date":"2015-05-13T02:00:00Z","reference_number":"EMA/COMP/360298/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310768-public-summary-opinion-orphan-designation-11-2-pyrrolidin-1-yl-ethoxy-1419-dioxa-5726-triaza-tetracyclo19311261812-heptacosa-125226358101227162123-decaene-treat_en.pdf"},
    {"id":"40493","name":"Draft assessment report on Eucalyptus globulus Labill., E. polybractea R.T. Baker and E. smithii R.T. Baker., aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2013-07-31T18:30:00Z","last_updated_date":"2013-07-31T18:30:00Z","reference_number":"EMA/HMPC/307782/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-eucalyptus-globulus-labill-e-polybractea-rt-baker-and-e-smithii-rt-baker-aetheroleum_en.pdf"},
    {"id":"40494","name":"CHMP summary of positive opinion for Vosevi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"EMA/CHMP/347210/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vosevi_en.pdf"},
    {"id":"40495","name":"Overview of comments received on 'Draft revision of EudraVigilance access policy for medicines for human use'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-01-13T14:35:00Z","last_updated_date":"2016-01-13T14:35:00Z","reference_number":"EMA/649218/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-revision-eudravigilance-access-policy-medicines-human-use_en.pdf"},
    {"id":"40496","name":"Presentation - A micro-, small- and medium-sized-enterprise perspective on the marketing-authorisation-application process (including e-dossier preparation and submission)(Martine Zimmermann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-micro-small-and-medium-sized-enterprise-perspective-marketing-authorisation-application-process-including-e-dossier-preparation-and-submissionmartine-zimmermann_en.pdf"},
    {"id":"40497","name":"Committee for medicinal products for human use, summary of positive opinion for Multaq","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/CHMP/376839/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-multaq_en.pdf"},
    {"id":"40498","name":"Eighteenth Meeting of the Management Board","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"1998-06-03T02:00:00Z","last_updated_date":"1998-06-03T02:00:00Z","reference_number":"EMEA/MB/015/98","document_url":"https://www.ema.europa.eu/en/documents/press-release/eighteenth-meeting-management-board_en.pdf"},
    {"id":"40499","name":"Withdrawal assessment report for Enthryv","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-11-06T01:00:00Z","last_updated_date":"2014-11-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-enthryv_en.pdf"},
    {"id":"40500","name":"EudraVigilance checklist and technical support plan for marketing authorisation holders and sponsors of clinical trials in the EEA","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2017-06-26T14:00:00Z","reference_number":"EMA/306740/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-checklist-and-technical-support-plan-marketing-authorisation-holders-and-sponsors-clinical-trials-eea_en.pdf"},
    {"id":"40501","name":"Alkem Article-31 referral - CHMP List of questions to Alkem BE Centre","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-01T02:00:00Z","last_updated_date":"2016-04-01T02:00:00Z","reference_number":"EMA/CHMP/228248/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/alkem-article-31-referral-chmp-list-questions-alkem-be-centre_en.pdf"},
    {"id":"40504","name":"Domperidone Article-31 referral - Annex IV","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-11T02:00:00Z","last_updated_date":"2014-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/domperidone-article-31-referral-annex-iv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/domperidone-article-31-referral-annex-iv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/domperidone-article-31-referral-annex-iv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/domperidone-article-31-referral-annex-iv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/domperidone-article-31-referral-annex-iv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/domperidone-article-31-referral-annex-iv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/domperidone-article-31-referral-annex-iv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/domperidone-article-31-referral-annex-iv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/domperidone-article-31-referral-annex-iv_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/domperidone-article-31-referral-annex-iv_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/domperidone-article-31-referral-annex-iv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/domperidone-article-31-referral-annex-iv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/domperidone-article-31-referral-annex-iv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/domperidone-article-31-referral-annex-iv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/domperidone-article-31-referral-annex-iv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/domperidone-article-31-referral-annex-iv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/domperidone-article-31-referral-annex-iv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/domperidone-article-31-referral-annex-iv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/domperidone-article-31-referral-annex-iv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/domperidone-article-31-referral-annex-iv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/domperidone-article-31-referral-annex-iv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/domperidone-article-31-referral-annex-iv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/domperidone-article-31-referral-annex-iv_sv.pdf"}},
    {"id":"40505","name":"Guidelines and concept papers adopted during the CHMP meeting 18-21 March 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T14:20:00Z","last_updated_date":"2013-04-02T14:20:00Z","reference_number":"EMA/CHMP/122529/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-18-21-march-2013_en.pdf"},
    {"id":"40507","name":"Draft list of references for assessment of: Echinaceae purpureae herba Echinacea purpurea (L.) Moench (purple coneflower herb)","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2007-03-08T00:09:21Z","last_updated_date":"2007-03-08T00:09:21Z","reference_number":"EMEA/HMPC/111536/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-echinaceae-purpureae-herba-echinacea-purpurea-l-moench-purple-coneflower-herb_en.pdf"},
    {"id":"40509","name":"Committee for Medicinal Products for Human use Summary of positive opinion for Zutectra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2009-09-24T02:00:00Z","last_updated_date":"2009-09-24T02:00:00Z","reference_number":"EMEA/CHMP/603846/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-zutectra_en.pdf"},
    {"id":"40510","name":"EMA response to Nordic Cochrane letter on EMA response to Nordic Cochrane letter on human papillomavirus (HPV) vaccines - Maladministration","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T13:30:00Z","last_updated_date":"2016-07-22T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-response-nordic-cochrane-letter-ema-response-nordic-cochrane-letter-human-papillomavirus-hpv-vaccines-maladministration_en.pdf"},
    {"id":"40511","name":"Questions and answers on the review of tolperisone-containing medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-06-22T14:00:00Z","last_updated_date":"2013-04-02T18:00:00Z","reference_number":"EMA/673365/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-review-tolperisone-containing-medicines_sv.pdf"}},
    {"id":"40512","name":"EU/3/14/1312: Public summary of opinion on orphan designation: Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for the treatment of congenital factor...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/COMP/434796/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141312-public-summary-opinion-orphan-designation-recombinant-factor-viia-modified-three-terminal-repeats-derived-i2-chain-human-chorionic-gonadotropin-treatment-congenital-factor_en.pdf"},
    {"id":"40513","name":"Flumethrin (Extension to sheep): Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-04-01T02:00:00Z","last_updated_date":"2000-04-01T02:00:00Z","reference_number":"EMEA/MRL/737/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/flumethrin-extension-sheep-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40516","name":"Presentation - The PRAC in PRACtice","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-05-30T18:10:00Z","last_updated_date":"2012-05-30T18:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prac-practice_en.pdf"},
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    {"id":"40532","name":"EU/3/17/1902: Public summary of opinion on orphan designation: N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide for the treatment o...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-10-17T02:00:00Z","last_updated_date":"2017-10-17T02:00:00Z","reference_number":"EMA/557429/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171902-public-summary-opinion-orphan-designation-n-2-6-26-dichloro-35-dimethoxyphenylcarbamoylmethylaminopyrimidin-4-ylamino-5-4-ethylpiperazin-1-ylphenylprop-2-enamide-treatment-o_en.pdf"},
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    {"id":"40540","name":"Draft assessment report on Lavandula angustifolia Mill., aetheroleum and Lavandula angustifolia Mill., flos","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2011-06-16T02:00:00Z","last_updated_date":"2011-06-16T02:00:00Z","reference_number":"EMA/HMPC/143183/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-lavandula-angustifolia-mill-aetheroleum-and-lavandula-angustifolia-mill-flos_en.pdf"},
    {"id":"40542","name":"Presentation - Sixth report on European Medicines Agency’s interaction with patients' and consumer's organisations - 2012 (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-07-02T17:00:00Z","last_updated_date":"2013-07-02T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sixth-report-european-medicines-agencys-interaction-patients-and-consumers-organisations-2012-nathalie-bere_en.pdf"},
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    {"id":"40551","name":"EMEA Public Statement on Metalyse - importance of correct product handling: syringe vial assembly","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2001-11-12T01:00:00Z","last_updated_date":"2001-11-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/emea-public-statement-metalyse-importance-correct-product-handling-syringe-vial-assembly_en.pdf"},
    {"id":"40552","name":"Presentation - Day 1: Visual function endpoints in clinical trials clinical view","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-1-visual-function-endpoints-clinical-trials-clinical-view_en.pdf"},
    {"id":"40554","name":"Acitretin: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation- PSUSA/00000051/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-10T02:00:00Z","last_updated_date":"2016-10-17T17:40:41Z","reference_number":"EMA/540531/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/acitretin-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000051201510_en.pdf"},
    {"id":"40555","name":"EU/3/02/123: Public summary of positive opinion for orphan designation of anti-CD147 murine monoclonal IgM for the treatment of Graft versus Host Disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2003-07-07T02:00:00Z","last_updated_date":"2003-07-07T02:00:00Z","reference_number":"EMEA/COMP/2391/02/Rev 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302123-public-summary-positive-opinion-orphan-designation-anti-cd147-murine-monoclonal-igm-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"40556","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human autologous adipose-derived stromal/stem Cells (ADSCs)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-08-18T13:00:00Z","last_updated_date":"2017-08-18T13:00:00Z","reference_number":"EMA/462732/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-autologous-adipose-derived-stromalstem-cells-adscs_en.pdf"},
    {"id":"40558","name":"EU/3/11/918: Public summary of opinion on orphan designation: Brivanib alaninate for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-11-23T16:00:00Z","last_updated_date":"2013-06-25T02:00:00Z","reference_number":"EMA/COMP/780640/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311918-public-summary-opinion-orphan-designation-brivanib-alaninate-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"40560","name":"Draft list of references supporting the assessment of Uncaria tomentosa (Willd. ex Schult.) DC., cortex","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2015-04-15T11:00:00Z","last_updated_date":"2015-04-15T11:00:00Z","reference_number":"EMA/HMPC/259599/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-uncaria-tomentosa-willd-ex-schult-dc-cortex_en.pdf"},
    {"id":"40561","name":"Overview of comments received on draft guideline on quality aspects of single-dose veterinary spot-on products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-02-11T01:00:00Z","last_updated_date":"2009-02-11T01:00:00Z","reference_number":"EMEA/CVMP/QWP/25621/2009","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-quality-aspects-single-dose-veterinary-spot-products_en.pdf"},
    {"id":"40564","name":"Presentation - Product information management - Annex: Example SmPC","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-information-management-annex-example-smpc_en.pdf"},
    {"id":"40567","name":"EU/3/08/573: Public summary of positive opinion for orphan designation of adeno-associated viral vector containing the human alpha sarcoglycan gene\n\nfor the treatment of alpha sarcoglycanopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2014-06-18T02:00:00Z","reference_number":"EMEA/COMP/479941/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308573-public-summary-positive-opinion-orphan-designation-adeno-associated-viral-vector-containing-human-alpha-sarcoglycan-gene-treatment-alpha-sarcoglycanopathy_en.pdf"},
    {"id":"40569","name":"Second ENCePP meeting with Centres at the EMEA (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) - List of Participants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-04-22T02:00:00Z","last_updated_date":"2008-04-22T02:00:00Z","reference_number":"EMEA/214880/2008","document_url":"https://www.ema.europa.eu/en/documents/other/second-encepp-meeting-centres-emea-european-network-centres-pharmacoepidemiology-and-pharmacovigilance-list-participants_en.pdf"},
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    {"id":"40624","name":"GVK Biosciences Article-31 referral - GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed 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    {"id":"40625","name":"11th meeting of the committee for veterinary medicinal products","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"1996-04-25T14:49:21Z","last_updated_date":"1996-04-25T14:49:21Z","reference_number":"EMEA/CVMP/081/96","document_url":"https://www.ema.europa.eu/en/documents/press-release/11th-meeting-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"40627","name":"Draft list of references for assessment of: Hyperici herba  Hypericum perforatum L.  (St. John´s wort) - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2008-11-06T01:00:00Z","last_updated_date":"2008-11-06T01:00:00Z","reference_number":"EMEA/HMPC/101620/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-hyperici-herba-hypericum-perforatum-l-st-johns-wort-first-version_en.pdf"},
    {"id":"40628","name":"Presentation - Progressing gene-therapy products to the clinic – a platform-based approach","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-progressing-gene-therapy-products-clinic-platform-based-approach_en.pdf"},
    {"id":"40629","name":"Presentation - Biomedical discovery through data mining and data science (Nicholas Tatonetti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-biomedical-discovery-through-data-mining-and-data-science-nicholas-tatonetti_en.pdf"},
    {"id":"40630","name":"Fosinopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00001475/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2016-10-18T13:42:39Z","reference_number":"EMA/242304/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/fosinopril-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00001475201507_en.pdf"},
    {"id":"40631","name":"Nafcillin: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2001-04-01T02:00:00Z","last_updated_date":"2001-04-01T02:00:00Z","reference_number":"EMEA/MRL/750/00-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/nafcillin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40632","name":"Draft list of references supporting the assessment of Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2014-09-12T02:00:00Z","last_updated_date":"2014-09-12T02:00:00Z","reference_number":"EMA/HMPC/36892/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus_en.pdf"},
    {"id":"40633","name":"Agenda - IPA introductory meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ipa-introductory-meeting_en.pdf"},
    {"id":"40634","name":"EU/3/12/961: Public summary of opinion on orphan designation: Doxycycline hyclate for the treatment of systemic amyloidosis caused by beta-2 microglobulin","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-19T11:45:00Z","last_updated_date":"2012-04-19T11:45:00Z","reference_number":"EMA/COMP/58844/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312961-public-summary-opinion-orphan-designation-doxycycline-hyclate-treatment-systemic-amyloidosis-caused-beta-2-microglobulin_en.pdf"},
    {"id":"40635","name":"Gadolinium Article-31 referral – Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-12-19T01:00:00Z","last_updated_date":"2017-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/gadolinium-article-31-referral-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gadolinium-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gadolinium-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gadolinium-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gadolinium-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gadolinium-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gadolinium-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gadolinium-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gadolinium-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gadolinium-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gadolinium-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gadolinium-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gadolinium-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gadolinium-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gadolinium-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gadolinium-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gadolinium-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gadolinium-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gadolinium-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gadolinium-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gadolinium-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gadolinium-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gadolinium-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/gadolinium-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/gadolinium-article-31-referral-annex-i_no.pdf"}},
    {"id":"40636","name":"Final European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2016-11-14T01:00:00Z","last_updated_date":"2016-11-14T01:00:00Z","reference_number":"EMA/HMPC/627057/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-harpagophytum-procumbens-dc-andor-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"40641","name":"CHMP post-authorisation summary of positive opinion for Onduarp","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2014-04-02T14:00:00Z","reference_number":"EMA/CHMP/261191/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-onduarp_en.pdf"},
    {"id":"40642","name":"Agenda - PRAC draft agenda of meeting 26-29 September 2016","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2016-09-26T18:30:00Z","last_updated_date":"2016-09-26T18:30:00Z","reference_number":"EMA/PRAC/635914/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-26-29-september-2016_en.pdf"},
    {"id":"40644","name":"Questions and answers on withdrawal of marketing authorisation application for Joulferon","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-04-29T02:00:00Z","last_updated_date":"2010-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-joulferon_sv.pdf"}},
    {"id":"40645","name":"Presentation - Modelling and simulation in support of adaptive designs","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-04-14T02:09:21Z","last_updated_date":"2008-04-14T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modelling-and-simulation-support-adaptive-designs_en.pdf"},
    {"id":"40647","name":"Minutes of the 70th meeting of the Management Board: 16-17 March 2011","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/MB/232704/2011","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_bg.pdf","es":"https://www.ema.europa.eu/es/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_cs.pdf","da":"https://www.ema.europa.eu/da/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_da.pdf","de":"https://www.ema.europa.eu/de/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_de.pdf","et":"https://www.ema.europa.eu/et/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_et.pdf","el":"https://www.ema.europa.eu/el/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_fr.pdf","it":"https://www.ema.europa.eu/it/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/minutes/minutes-70th-meeting-management-board-16-17-march-2011_sv.pdf"}},
    {"id":"40648","name":"Divergent opinion on maximum residue limits of 'Purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids (as potassium salts)'","type":"mrl-divergent-opinion","status":"unknown","consultation_date":"","first_published_date":"2016-02-17T01:00:00Z","last_updated_date":"2016-02-17T17:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-divergent-opinion/divergent-opinion-maximum-residue-limits-purified-semi-solid-extract-humulus-lupulus-l-containing-approximately-48-beta-acids-potassium-salts_en.pdf"},
    {"id":"40649","name":"Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring addressed to Member States for IV Tamiflu available for compassionate use","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-01-21T00:09:21Z","last_updated_date":"2013-08-30T17:52:00Z","reference_number":"EMA/CHMP/781264/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/conditions-use-conditions-distribution-and-patients-targeted-and-conditions-safety-monitoring-addressed-member-states-iv-tamiflu-available-compassionate-use_en.pdf"},
    {"id":"40650","name":"Presentation - Update on development of pharmacovigilance information systems (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-12T01:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-development-pharmacovigilance-information-systems-peter-arlett_en.pdf"},
    {"id":"40651","name":"Presentation - CVMP work programme 2013 (Anja Holm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-04-08T14:00:00Z","last_updated_date":"2013-04-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-work-programme-2013-anja-holm_en.pdf"},
    {"id":"40652","name":"European Commission DG Sanco activities in the field of antimicrobial resistance - Kris De Smet","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/european-commission-dg-sanco-activities-field-antimicrobial-resistance-kris-de-smet_en.pdf"},
    {"id":"40654","name":"Framework for interaction between the European Medicines Agency and industry stakeholders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-06T12:00:00Z","last_updated_date":"2015-10-06T12:00:00Z","reference_number":"EMA/591272/2014","document_url":"https://www.ema.europa.eu/en/documents/other/framework-interaction-between-european-medicines-agency-and-industry-stakeholders_en.pdf"},
    {"id":"40655","name":"Corlentor and Procoralan Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-08T20:00:00Z","last_updated_date":"2014-05-08T20:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/corlentor-and-procoralan-article-20-procedure-notification_en.pdf"},
    {"id":"40657","name":"News bulletin for small and medium-sized enterprises - Issue 19","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2012-03-14T15:35:00Z","last_updated_date":"2012-03-14T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-19_en.pdf"},
    {"id":"40658","name":"Draft guideline on the Core SPC for human Anti-D immunoglobulin for intramuscular use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-04-27T02:00:00Z","last_updated_date":"2006-04-27T02:00:00Z","reference_number":"CPMP/BPWG/574/99 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-spc-human-anti-d-immunoglobulin-intramuscular-use_en.pdf"},
    {"id":"40659","name":"Final opinion of the HMPC on a European Union herbal monograph on Echinacea pallida (Nutt.) Nutt., radix - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-08-14T12:00:00Z","last_updated_date":"2018-08-14T12:00:00Z","reference_number":"EMA/HMPC/482923/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-echinacea-pallida-nutt-nutt-radix-revision-1_en.pdf"},
    {"id":"40660","name":"Organisation chart: Deputy Executive Director support services","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-09-01T02:00:00Z","last_updated_date":"2019-12-19T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/organisation-chart-deputy-executive-director-support-services_en.pdf"},
    {"id":"40663","name":"Overview of comments received on 'Draft memantine product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-04-10T15:28:00Z","last_updated_date":"2015-04-10T15:28:00Z","reference_number":"EMA/CHMP/116526/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-memantine-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"40664","name":"Key considerations for a new chemical entity (NCE) - Ryan Tomlinson","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-08T01:00:00Z","last_updated_date":"2008-02-08T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/key-considerations-new-chemical-entity-nce-ryan-tomlinson_en.pdf"},
    {"id":"40666","name":"Presentation - Day 2: Dry eyes – regulatory perspectives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-dry-eyes-regulatory-perspectives_en.pdf"},
    {"id":"40670","name":"Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-10-23T15:27:00Z","last_updated_date":"2017-10-23T15:36:00Z","reference_number":"EMA/697322/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/allopurinol-list-nationally-authorised-medicinal-products-psusa00000095201612_en.pdf"},
    {"id":"40671","name":"Superseded assessment report for the development of community monographs and for inclusion of herbal substance(s), preparation(s) or combinations thereof in the list Equisetum arvense L., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2008-07-03T02:09:21Z","last_updated_date":"2016-03-17T01:09:21Z","reference_number":"EMEA/HMPC/394895/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-development-community-monographs-and-inclusion-herbal-substances-preparations-or-combinations-thereof-list-equisetum-arvense-l-herba_en.pdf"},
    {"id":"40672","name":"Presentation - PIP session: Overview of paediatric legislation for pharmaceuticals","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pip-session-overview-paediatric-legislation-pharmaceuticals_en.pdf"},
    {"id":"40673","name":"EU/3/16/1726 : Public summary of opinion on orphan designation: Recombinant human acid alpha-glucosidase conjugated with mannose-6-phosphate analogues for the treatment of glycogen storage disease type II (Pompe’s diseas...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161726-public-summary-opinion-orphan-designation-recombinant-human-acid-alpha-glucosidase-conjugated-mannose-6-phosphate-analogues-treatment-glycogen-storage-disease-type-ii-pompes-diseas_en.pdf"},
    {"id":"40674","name":"Medicines regulators on both sides of the Atlantic confirm commitment to cooperation on medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2008-10-07T02:09:21Z","last_updated_date":"2008-10-07T02:09:21Z","reference_number":"EMEA/515723/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/medicines-regulators-both-sides-atlantic-confirm-commitment-cooperation-medicines_en.pdf"},
    {"id":"40675","name":"Presentation - Industry challenges for producing emergency vaccines in Europe (Alasdair King)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-18T11:37:00Z","last_updated_date":"2017-05-18T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-challenges-producing-emergency-vaccines-europe-alasdair-king_en.pdf"},
    {"id":"40676","name":"Codeine Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"EMA/PRAC/180085/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-prac-list-questions_en.pdf-0"},
    {"id":"40677","name":"Agenda - Workshop on stem cell-based therapies","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"EMA/CAT/80413/2010","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-stem-cell-based-therapies_en.pdf"},
    {"id":"40680","name":"Day 80 assessment report generics overview guidance","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2015-02-20T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-generics-overview-guidance_en.pdf"},
    {"id":"40682","name":"EU/3/14/1375: Public summary of opinion on orphan designation: Pro-Pro-Thr-Val-Pro-Thr-Arg for treatment of xeroderma pigmentosum","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2022-02-25T01:00:00Z","reference_number":"EMA/COMP/660612/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141375-public-summary-opinion-orphan-designation-pro-pro-thr-val-pro-thr-arg-treatment-xeroderma-pigmentosum_en.pdf"},
    {"id":"40683","name":"Misoprostol (gynaecological indication - termination of pregnancy): List of nationally authorised medicinal products - PSUSA/00010354/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-03-09T16:05:00Z","last_updated_date":"2018-03-09T16:07:00Z","reference_number":"EMA/9690/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gynaecological-indication-termination-pregnancy-list-nationally-authorised-medicinal-products-psusa00010354201705_en.pdf"},
    {"id":"40684","name":"Summary - European Medicines Agency workshop with European Union pharmaceutical industry associations on the implementation of Article 57(2), second subparagraph of Regulation (EC) No.726/2004","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2012-07-06T17:00:00Z","last_updated_date":"2012-07-06T17:00:00Z","reference_number":"EMA/322628/2012","document_url":"https://www.ema.europa.eu/en/documents/minutes/summary-european-medicines-agency-workshop-european-union-pharmaceutical-industry-associations-implementation-article-572-second-subparagraph-regulation-ec-no7262004_en.pdf"},
    {"id":"40685","name":"Opinion of the CVMP on the establishment of maximum residue limits: Aluminium salicylate, basic","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-09-17T16:50:00Z","last_updated_date":"2015-09-17T16:50:00Z","reference_number":"EMA/CVMP/587830/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-aluminium-salicylate-basic_en.pdf"},
    {"id":"40686","name":"Meeting highlights from the Paediatric Committee: 15 - 17 October 2008","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-10-24T02:00:00Z","last_updated_date":"2009-10-24T02:00:00Z","reference_number":"EMEA/PDCO/552811/2008","document_url":"https://www.ema.europa.eu/en/documents/press-release/meeting-highlights-paediatric-committee-15-17-october-2008_en.pdf"},
    {"id":"40690","name":"An alternative approach to drug development in children with Gaucher disease: a collaborative proposal from the European Medicines Agency and the Food and Drug Administration","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-11-28T01:00:00Z","last_updated_date":"2012-11-28T01:00:00Z","reference_number":"EMA/754506/2012","document_url":"https://www.ema.europa.eu/en/documents/other/alternative-approach-drug-development-children-gaucher-disease-collaborative-proposal-european-medicines-agency-and-food-and-drug-administration_en.pdf"},
    {"id":"40692","name":"Application form for orphan-medicinal-product designation","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2011-11-24T01:00:00Z","last_updated_date":"2017-09-26T12:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/application-form-orphan-medicinal-product-designation_en.pdf"},
    {"id":"40695","name":"Registration form - 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-04-25T16:00:00Z","last_updated_date":"2018-04-25T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/registration-form-2018-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"40698","name":"EU/3/14/1378: Public summary of opinion on orphan designation: Diaspirin cross-linked haemoglobin for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-01-16T01:00:00Z","last_updated_date":"2015-01-16T01:00:00Z","reference_number":"EMA/COMP/652847/2014 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141378-public-summary-opinion-orphan-designation-diaspirin-cross-linked-haemoglobin-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"40699","name":"EU/3/09/639: Public summary of positive opinion for orphan designation\n\nof 4,6,8-trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-09T02:00:00Z","last_updated_date":"2013-10-17T13:25:00Z","reference_number":"EMEA/COMP/24006/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309639-public-summary-positive-opinion-orphan-designation-468-trihydroxy-10-3711-trimethyldodeca-2610-trienyl-510-dihydrodibenzobe14-diazepin-11-one-treatment-glioma_en.pdf"},
    {"id":"40701","name":"Milaxyn Plus: Article 34 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-07-23T02:00:00Z","last_updated_date":"2012-07-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/milaxyn-plus-article-34-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"40703","name":"Initiative for patient registries - Strategy and pilot phase","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-12T02:00:00Z","last_updated_date":"2015-10-12T02:00:00Z","reference_number":"EMA/176050/2014","document_url":"https://www.ema.europa.eu/en/documents/other/initiative-patient-registries-strategy-and-pilot-phase_en.pdf"},
    {"id":"40704","name":"EU/3/13/1149: Public summary of opinion on orphan designation: Human haemin for the prevention of ischaemia reperfusion injury associated with solid-organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2013-08-22T17:30:00Z","last_updated_date":"2013-08-22T17:30:00Z","reference_number":"EMA/COMP/399770/2013","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3131149-public-summary-opinion-orphan-designation-human-haemin-prevention-ischaemia-reperfusion-injury-associated-solid-organ-transplantation_en.pdf"},
    {"id":"40705","name":"Zestril - Article 30 referral - Annex I, II, III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2004-08-10T01:59:00Z","last_updated_date":"2004-08-10T01:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zestril-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"es":"https://www.ema.europa.eu/es/documents/referral/zestril-article-30-referral-annex-i-ii-iii_es.pdf","da":"https://www.ema.europa.eu/da/documents/referral/zestril-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/zestril-article-30-referral-annex-i-ii-iii_de.pdf","el":"https://www.ema.europa.eu/el/documents/referral/zestril-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/zestril-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/zestril-article-30-referral-annex-i-ii-iii_it.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/zestril-article-30-referral-annex-i-ii-iii_nl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/zestril-article-30-referral-annex-i-ii-iii_pt.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/zestril-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/zestril-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"40706","name":"Final European Union herbal monograph on Aloe barbadensis Mill. and on Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2017-04-10T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMA/HMPC/625788/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-aloe-barbadensis-mill-and-aloe-various-species-mainly-aloe-ferox-mill-and-its-hybrids-folii-succus-siccatus_en.pdf"},
    {"id":"40710","name":"Maci Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T02:00:00Z","last_updated_date":"2014-09-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/maci-article-20-procedure-notification_en.pdf"},
    {"id":"40712","name":"EU/3/06/418: Public summary of positive opinion of iodine (131I) anti-tenascin monoclonal antibody 81C6 for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-06-15T02:00:00Z","last_updated_date":"2016-02-10T01:00:00Z","reference_number":"EMEA/COMP/221961/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306418-public-summary-positive-opinion-iodine-131i-anti-tenascin-monoclonal-antibody-81c6-treatment-glioma_en.pdf"},
    {"id":"40713","name":"Superseded assessment report on Centella asiatica (L.) Urban, herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-09-02T17:50:00Z","last_updated_date":"2022-09-02T17:50:00Z","reference_number":"EMA/HMPC/291177/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-assessment-report-centella-asiatica-l-urban-herba_en.pdf"},
    {"id":"40715","name":"Ambroxol and bromhexine Article-31 referral - Divergent opinion (Netherlands)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2016-02-05T09:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ambroxol-and-bromhexine-article-31-referral-divergent-opinion-netherlands_en.pdf"},
    {"id":"40716","name":"Concept paper on preparation of an addendum to the guideline on development of antibacterial agents to specifically address the clinical development of new agents to treat tuberculosis","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2007-04-26T02:00:00Z","last_updated_date":"2007-04-26T02:00:00Z","reference_number":"EMEA/CHMP/EWP/122355/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-preparation-addendum-guideline-development-antibacterial-agents-specifically-address-clinical-development-new-agents-treat-tuberculosis_en.pdf"},
    {"id":"40717","name":"Presentation - Introduction to EMA - Training session for patients and consumers involved in EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-20T01:00:00Z","last_updated_date":"2016-12-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-ema-training-session-patients-and-consumers-involved-ema_en.pdf"},
    {"id":"40718","name":"Presentation - The European Network of Paediatric Research (Peter Helms)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-paediatric-research-peter-helms_en.pdf"},
    {"id":"40720","name":"Pre-notification check for type IB Variations","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-11-06T13:00:00Z","last_updated_date":"2015-11-06T13:00:00Z","reference_number":"EMA/413829/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/pre-notification-check-type-ib-variations_en.pdf"},
    {"id":"40721","name":"Hydroxyethyl starch Article-107i procedure - Stakeholders' submission form","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-07-12T14:00:00Z","last_updated_date":"2013-07-12T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-procedure-stakeholders-submission-form_en.pdf"},
    {"id":"40723","name":"Moxidectin (Extension to horses): Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-07-01T02:00:00Z","last_updated_date":"1997-07-01T02:00:00Z","reference_number":"EMEA/MRL/250/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/moxidectin-extension-horses-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40724","name":"Presentation - The research potentials of MetabERN: a survey to investigate and prioritise actions (Jean Michel Heard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-19T19:00:00Z","last_updated_date":"2018-06-19T19:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-research-potentials-metabern-survey-investigate-and-prioritise-actions-jean-michel-heard_en.pdf"},
    {"id":"40725","name":"Workshop outcome and recommendations - Current use and future needs of radiopharmaceuticals labelled with radionuclides produced in reactors and possible alternatives","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-16T02:00:00Z","last_updated_date":"2010-06-16T02:00:00Z","reference_number":"EMA/150127/2010","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-outcome-and-recommendations-current-use-and-future-needs-radiopharmaceuticals-labelled-radionuclides-produced-reactors-and-possible-alternatives_en.pdf"},
    {"id":"40727","name":"EU/3/11/851: Public summary of positive opinion for orphan designation:  Glufosfamide for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-04-26T02:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/COMP/45835/2011 ev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311851-public-summary-positive-opinion-orphan-designation-glufosfamide-treatment-pancreatic-cancer_en.pdf"},
    {"id":"40729","name":"Tylosin: Summary Report (2) – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-23T02:00:00Z","last_updated_date":"1996-05-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tylosin-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40735","name":"CHMP post-authorisation summary of positive opinion for Opdivo","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2017-03-24T13:00:00Z","last_updated_date":"2017-03-24T13:00:00Z","reference_number":"EMA/CHMP/193182/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo_en.pdf-4"},
    {"id":"40739","name":"Presentation - Minor-use-minor-species (MUMS) policy: Industry feedback (Ludwig Klostermann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-03-30T02:00:00Z","last_updated_date":"2015-03-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-minor-use-minor-species-mums-policy-industry-feedback-ludwig-klostermann_en.pdf"},
    {"id":"40741","name":"Azithromycin (systemic use formulations): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"40778","name":"Minutes of the European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting February 2014","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T13:40:00Z","last_updated_date":"2014-04-28T13:40:00Z","reference_number":"EMA/116971/2014","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agency-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-february-2014_en.pdf"},
    {"id":"40779","name":"Agenda - CAT agenda of the 15-16 October 2015 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-10-21T12:00:00Z","last_updated_date":"2015-10-21T12:00:00Z","reference_number":"EMA/CAT/691987/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-16-october-2015-meeting_en.pdf"},
    {"id":"40782","name":"Serenoa repens: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-08-01T02:09:21Z","last_updated_date":"1999-08-01T02:09:21Z","reference_number":"EMEA/MRL/676/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/serenoa-repens-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40785","name":"Presentation - Cystic fibrosis demographic challenges for Europe (J Stuart Elborn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-12-11T01:00:00Z","last_updated_date":"2012-12-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cystic-fibrosis-demographic-challenges-europe-j-stuart-elborn_en.pdf"},
    {"id":"40787","name":"Committee for Medicinal Products for Human Use (CHMP) - May 2010 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/CHMP/330906/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-may-2010-plenary-meeting-monthly-report_en.pdf"},
    {"id":"40788","name":"Concept paper on the harmonisation and update of the clinical aspects in the authorised conditions of use for radiopharmaceuticals and other diagnostic medicinal products","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2008-04-24T02:00:00Z","last_updated_date":"2008-04-24T02:00:00Z","reference_number":"EMEA/CHMP/EWP/12052/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-harmonisation-and-update-clinical-aspects-authorised-conditions-use-radiopharmaceuticals-and-other-diagnostic-medicinal-products_en.pdf"},
    {"id":"40789","name":"Mitigating risks due to the use of antibiotics in animals","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-12-19T15:00:00Z","last_updated_date":"2014-12-19T15:00:00Z","reference_number":"EMA/787672/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/mitigating-risks-due-use-antibiotics-animals_en.pdf"},
    {"id":"40790","name":"Paracetamol Article-31 referral - CMDh divergent position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-01T01:00:00Z","last_updated_date":"2018-03-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/paracetamol-article-31-referral-cmdh-divergent-position_en.pdf"},
    {"id":"40791","name":"Presentation - Scientific advice (Jane Moseley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-05-06T18:00:00Z","last_updated_date":"2013-05-06T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advice-jane-moseley_en.pdf"},
    {"id":"40792","name":"EU/3/15/1578: Public summary of opinion on orphan designation: \n\nAdenovirus associated viral vector serotype 8 containing the human CNGB3 gene for the treatment of achromatopsia caused by mutations in the CNGB3 gene","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-01-22T01:00:00Z","last_updated_date":"2016-01-22T01:00:00Z","reference_number":"EMA/COMP/699673/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151578-public-summary-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-8-containing-human-cngb3-gene-treatment-achromatopsia-caused-mutations-cngb3-gene_en.pdf"},
    {"id":"40793","name":"Tienam - Article 30 Referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2012-02-20T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tienam-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/tienam-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/tienam-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/tienam-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/tienam-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/tienam-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/tienam-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/tienam-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/tienam-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/tienam-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/tienam-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/tienam-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/tienam-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/tienam-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/tienam-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/tienam-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/tienam-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/tienam-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/tienam-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/tienam-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/tienam-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/tienam-article-30-referral-annex-iii_sv.pdf"}},
    {"id":"40794","name":"Butylscopolaminium bromide: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1997-11-01T01:00:00Z","last_updated_date":"1997-11-01T01:00:00Z","reference_number":"EMEA/MRL/244/97-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/butylscopolaminium-bromide-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40795","name":"EMLA cream Article-30 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/emla-cream-article-30-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/emla-cream-article-30-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/emla-cream-article-30-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/emla-cream-article-30-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/emla-cream-article-30-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/emla-cream-article-30-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/emla-cream-article-30-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/emla-cream-article-30-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/emla-cream-article-30-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/emla-cream-article-30-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/emla-cream-article-30-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/emla-cream-article-30-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/emla-cream-article-30-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/emla-cream-article-30-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/emla-cream-article-30-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/emla-cream-article-30-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/emla-cream-article-30-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/emla-cream-article-30-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/emla-cream-article-30-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/emla-cream-article-30-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/emla-cream-article-30-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/emla-cream-article-30-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/emla-cream-article-30-referral-annex-ii_sv.pdf"}},
    {"id":"40797","name":"Committee for Advanced Therapies (CAT) monthly report of application procedures, guidelines and related documents on advanced therapies: January 2012 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2012-01-24T12:41:00Z","last_updated_date":"2012-01-24T12:41:00Z","reference_number":"EMA/CAT/47894/2012","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-january-2012-meeting_en.pdf"},
    {"id":"40798","name":"Agenda - CAT agenda of the 17-18 September 2015 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-09-25T15:45:00Z","last_updated_date":"2015-09-25T15:45:00Z","reference_number":"EMA/CAT/629516/2015","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-17-18-september-2015-meeting_en.pdf"},
    {"id":"40800","name":"Draft community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2009-05-14T02:09:21Z","last_updated_date":"2009-05-14T02:09:21Z","reference_number":"EMEA/HMPC/585558/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos_en.pdf"},
    {"id":"40802","name":"CHMP post-authorisation summary of positive opinion for Darzalex","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-02-24T01:00:00Z","last_updated_date":"2017-02-24T01:00:00Z","reference_number":"EMA/CHMP/126505/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex_en.pdf"},
    {"id":"40803","name":"Inventory of paediatric therapeutic needs - Respiratory","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2016-10-07T14:08:00Z","last_updated_date":"2016-10-07T14:08:00Z","reference_number":"EMA/PDCO/528943/2016","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-therapeutic-needs-respiratory_en.pdf"},
    {"id":"40804","name":"Superseded final list of references supporting the assessment of Tanacetum parthenium (L.) Schulz Bip., herba - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2011-06-20T02:00:00Z","last_updated_date":"2020-08-14T02:00:00Z","reference_number":"EMA/HMPC/587580/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-references-supporting-assessment-tanacetum-parthenium-l-schulz-bip-herba-first-version_en.pdf"},
    {"id":"40807","name":"Divergent position on a CVMP opinion on an Article-33 referral of Directive 2001/82/EC for Florgane 300-mg/ml suspension for injection for cattle and pigs","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-07-10T14:30:00Z","last_updated_date":"2013-07-10T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-33-referral-directive-200182ec-florgane-300-mgml-suspension-injection-cattle-and-pigs_en.pdf"},
    {"id":"40808","name":"Presentation - Drafting work plan 2018 - 2019 (I. Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T17:12:00Z","last_updated_date":"2017-12-11T17:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-drafting-work-plan-2018-2019-i-silva_en.pdf"},
    {"id":"40812","name":"Commitee for Orphan Medicinal Products: March 2004 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2004-03-17T01:00:00Z","last_updated_date":"2004-03-17T01:00:00Z","reference_number":"EMEA/COMP/134/04","document_url":"https://www.ema.europa.eu/en/documents/press-release/commitee-orphan-medicinal-products-march-2004-meeting_en.pdf"},
    {"id":"40815","name":"CHMP post-authorisation summary of positive opinion for MabThera","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-03-22T13:00:00Z","last_updated_date":"2013-03-22T13:00:00Z","reference_number":"EMA/CHMP/166944/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mabthera_en.pdf-0"},
    {"id":"40818","name":"EU/3/09/678: Public summary of positive opinion for orphan designation\n\nof (-)-trans-3-(5,6-dihydro-4H-pyrrolo[3,2,1-ij]quinolin-1yl)-4-(1H-indol-3-yl) pyrrolidine-2, 5-dione for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-20T02:00:00Z","last_updated_date":"2014-01-22T01:00:00Z","reference_number":"EMEA/COMP/444936/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu309678-public-summary-positive-opinion-orphan-designation-trans-3-56-dihydro-4h-pyrrolo321-ijquinolin-1yl-4-1h-indol-3-yl-pyrrolidine-2-5-dione-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"40819","name":"Walnut leaf - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2014-10-10T02:00:00Z","reference_number":"EMA/HMPC/432131/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/walnut-leaf-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/walnut-leaf-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/walnut-leaf-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/walnut-leaf-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/walnut-leaf-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/walnut-leaf-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/walnut-leaf-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/walnut-leaf-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/walnut-leaf-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/walnut-leaf-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/walnut-leaf-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/walnut-leaf-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/walnut-leaf-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/walnut-leaf-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/walnut-leaf-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/walnut-leaf-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/walnut-leaf-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/walnut-leaf-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/walnut-leaf-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/walnut-leaf-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/walnut-leaf-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/walnut-leaf-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/walnut-leaf-summary-public_sv.pdf"}},
    {"id":"40820","name":"Fluvastatin: List of nationally authorised medicinal products - PSUSA-00001457-201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-04T12:30:00Z","last_updated_date":"2018-07-04T12:30:00Z","reference_number":"EMA/443956/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluvastatin-list-nationally-authorised-medicinal-products-psusa-00001457-201708_en.pdf"},
    {"id":"40823","name":"European Medicines Agency’s Management Board backs EMEA conflicts of interests policy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-05-27T02:09:21Z","last_updated_date":"2005-05-27T02:09:21Z","reference_number":"EMEA/179731/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agencys-management-board-backs-emea-conflicts-interests-policy_en.pdf"},
    {"id":"40826","name":"Moxifloxacin (systemic use):  List of nationally authorised medicinal products - PSUSA/00009231/201605","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-03-09T16:10:00Z","last_updated_date":"2017-03-09T16:15:00Z","reference_number":"EMA/167321/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/moxifloxacin-systemic-use-list-nationally-authorised-medicinal-products-psusa00009231201605_en.pdf"},
    {"id":"40829","name":"ICH: S 2 (R1): Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2008-03-01T01:00:00Z","last_updated_date":"2008-03-01T01:00:00Z","reference_number":"EMEA/CHMP/ICH/126642/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-2-r1-guidance-genotoxicity-testing-and-data-interpretation-pharmaceuticals-intended-human-use-step-3_en.pdf"},
    {"id":"40831","name":"EU/3/14/1386: Public summary of positive opinion for orphan designation: 2-hydroxymethyl-2-methoxymethyl-1-azabicyclo[2,2,2]octan-3-one for the treatment of ovarian cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/725365/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141386-public-summary-positive-opinion-orphan-designation-2-hydroxymethyl-2-methoxymethyl-1-azabicyclo222octan-3-one-treatment-ovarian-cancer_en.pdf"},
    {"id":"40834","name":"Presentation - What are the real-world evidence tools and how can they support decision making? (Dr Alison Cave)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-are-real-world-evidence-tools-and-how-can-they-support-decision-making-dr-alison-cave_en.pdf"},
    {"id":"40837","name":"Final list of references supporting the assessment of Aloe barbadensis Mill. and Aloe (various species, mainly Aloe ferox Mill. and its hybrids), folii succus siccatus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2017-04-10T02:00:00Z","last_updated_date":"2017-04-10T02:00:00Z","reference_number":"EMEA/HMPC/759584/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-aloe-barbadensis-mill-and-aloe-various-species-mainly-aloe-ferox-mill-and-its-hybrids-folii-succus-siccatus_en.pdf"},
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    {"id":"40841","name":"Toldimfos: Summary Report – Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1999-12-01T01:00:00Z","last_updated_date":"1999-12-01T01:00:00Z","reference_number":"EMEA/MRL/717/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/toldimfos-summary-report-committee-veterinary-medicinal-products_en.pdf"},
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    {"id":"40844","name":"Roxithromycin: List of nationally authorised medicinal products - PSUSA/00002669/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-22T12:00:00Z","last_updated_date":"2016-10-18T11:22:48Z","reference_number":"EMA/626672/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/roxithromycin-list-nationally-authorised-medicinal-products-psusa00002669201412_en.pdf"},
    {"id":"40845","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 13-15 March 2013","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2013-03-25T12:30:00Z","last_updated_date":"2013-03-25T12:30:00Z","reference_number":"EMA/PDCO/16009/2013","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-13-15-march-2013_en.pdf"},
    {"id":"40846","name":"Presentation - European Medicines Agency public workshop - Best expertise versus conflicts of interests: Striking the right balance (Guido Rasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-10-02T14:00:00Z","last_updated_date":"2013-10-02T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-public-workshop-best-expertise-versus-conflicts-interests-striking-right-balance-guido-rasi_en.pdf"},
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    {"id":"40849","name":"Zinbryta Article-20 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-06-09T17:41:00Z","last_updated_date":"2017-06-09T17:41:00Z","reference_number":"EMA/366148/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/zinbryta-article-20-referral-review-started_en.pdf"},
    {"id":"40851","name":"CHMP post-authorisation summary of positive opinion for Komboglyze","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-01-18T01:00:00Z","reference_number":"EMA/CHMP/35983/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-komboglyze_en.pdf-1"},
    {"id":"40852","name":"Guidelines and concept papers adopted during the CHMP meeting 22-25 July 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-08-21T17:00:00Z","last_updated_date":"2013-08-21T17:00:00Z","reference_number":"EMA/CHMP/241120/2013","document_url":"https://www.ema.europa.eu/en/documents/other/guidelines-and-concept-papers-adopted-during-chmp-meeting-22-25-july-2013_en.pdf"},
    {"id":"40855","name":"Final assessment report on Piper methysticum G. Forst., rhizoma","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-04-13T02:00:00Z","last_updated_date":"2018-04-13T02:00:00Z","reference_number":"EMA/HMPC/450589/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-piper-methysticum-g-forst-rhizoma_en.pdf"},
    {"id":"40856","name":"Standard operating procedure on the organisation of Name Review Group meetings","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2011-04-18T02:00:00Z","last_updated_date":"2011-04-18T02:00:00Z","reference_number":"SOP/H/3213","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-organisation-name-review-group-meetings_en.pdf"},
    {"id":"40858","name":"CHMP summary of positive opinion for Imatinib medac","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-08-05T02:00:00Z","last_updated_date":"2013-08-05T02:00:00Z","reference_number":"Imatinib medac","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imatinib-medac_en.pdf"},
    {"id":"40859","name":"Agenda - European Medicines Agency/European Federation of Pharmaceutical Industries and Associations workshop: Integrating pharmacogenomics early into drug development: Pharmacokinetics as a working example","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2008-12-19T00:09:21Z","last_updated_date":"2008-12-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agencyeuropean-federation-pharmaceutical-industries-and-associations-workshop-integrating-pharmacogenomics-early-drug-development-pharmacokinetics-working-example_en.pdf"},
    {"id":"40861","name":"Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Alarelin","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-02-02T09:50:00Z","last_updated_date":"2018-02-02T09:50:00Z","reference_number":"EMA/CVMP/185578/2017","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-committee-medicinal-products-veterinary-use-establishment-maximum-residue-limits-alarelin_en.pdf"},
    {"id":"40862","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final addendum I to module XVI on educational materials and, for public consultation draft revision 1 of module XV on safet...","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2015-12-15T12:30:00Z","last_updated_date":"2015-12-15T12:30:00Z","reference_number":"EMA/772189/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-final-addendum-i-module-xvi-educational-materials-and-public-consultation-draft-revision-1-module-xv-safet_en.pdf"},
    {"id":"40863","name":"Overview of comments received on Community herbal monograph on Ilex paraguariensis St. Hilaire, folium - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-02-14T01:00:00Z","last_updated_date":"2011-02-14T01:00:00Z","reference_number":"EMA/HMPC/139995/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-ilex-paraguariensis-st-hilaire-folium-first-version_en.pdf"},
    {"id":"40865","name":"Survey 2006 on the performance of EMEA scientific procedures for medicinal products for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-03-21T00:09:21Z","last_updated_date":"2007-03-21T00:09:21Z","reference_number":"EMEA/489472/2006","document_url":"https://www.ema.europa.eu/en/documents/other/survey-2006-performance-emea-scientific-procedures-medicinal-products-human-use_en.pdf"},
    {"id":"40867","name":"One year extension of data protection for new indication of well-established use product assessment report template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T15:00:00Z","last_updated_date":"2018-09-18T17:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/one-year-extension-data-protection-new-indication-well-established-use-product-assessment-report-template_en.docx"},
    {"id":"40869","name":"Overview of comments received on draft guideline for the quality of biological active substances produced by stable transgene expression in higher plants","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-24T02:00:00Z","last_updated_date":"2008-07-24T02:00:00Z","reference_number":"EMEA/CHMP/BWP/125862/2008","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-quality-biological-active-substances-produced-stable-transgene-expression-higher-plants_en.pdf"},
    {"id":"40871","name":"Arimidex - Article 30 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-07-27T02:00:00Z","last_updated_date":"2011-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/arimidex-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/arimidex-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/arimidex-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/arimidex-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/arimidex-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/arimidex-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/arimidex-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/arimidex-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/arimidex-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/arimidex-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/arimidex-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/arimidex-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/arimidex-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/arimidex-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/arimidex-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/arimidex-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/arimidex-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/arimidex-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/arimidex-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/arimidex-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/arimidex-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/arimidex-article-30-referral-annex-iii_sv.pdf"}},
    {"id":"40875","name":"Good manufacturing practice for advanced-therapy medicinal products: Status","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-07-14T02:00:00Z","last_updated_date":"2008-07-14T02:00:00Z","reference_number":"EMEA/INS/GMP/372447/2008","document_url":"https://www.ema.europa.eu/en/documents/other/good-manufacturing-practice-advanced-therapy-medicinal-products-status_en.pdf"},
    {"id":"40877","name":"CMDh endorses suspension of methadone oral solutions containing high molecular weight povidone","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-07-24T02:00:00Z","last_updated_date":"2014-07-24T02:00:00Z","reference_number":"EMA/444346/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/cmdh-endorses-suspension-methadone-oral-solutions-containing-high-molecular-weight-povidone_en.pdf"},
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    {"id":"40879","name":"Presentation - Substance and product management services (P&SMS) update","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-06T11:40:00Z","last_updated_date":"2018-07-06T11:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-and-product-management-services-psms-update_en.pdf"},
    {"id":"40882","name":"Overview of comments received on 'Guideline on adjustment for baseline covariates'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-03-27T17:00:00Z","last_updated_date":"2015-03-27T17:00:00Z","reference_number":"EMA/40143/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-adjustment-baseline-covariates_en.pdf"},
    {"id":"40883","name":"EU/3/10/814: Public summary of opinion on orphan designation: Recombinant human von Willebrand factor for the treatment of von Willebrand disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/COMP/578646/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310814-public-summary-opinion-orphan-designation-recombinant-human-von-willebrand-factor-treatment-von-willebrand-disease_en.pdf"},
    {"id":"40885","name":"Preclinical immunogenicity testing - Christian Ross, Lisbeth Bjerring Jensen, Inger Mollerup","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2007-09-04T02:09:21Z","last_updated_date":"2007-09-04T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/preclinical-immunogenicity-testing-christian-ross-lisbeth-bjerring-jensen-inger-mollerup_en.pdf"},
    {"id":"40886","name":"CVMP strategy on antimicrobials 2011-2015","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2011-07-25T03:00:00Z","last_updated_date":"2011-07-25T03:00:00Z","reference_number":"EMA/CVMP/287420/2010","document_url":"https://www.ema.europa.eu/en/documents/report/cvmp-strategy-antimicrobials-2011-2015_en.pdf"},
    {"id":"40887","name":"Guideline on the scientific application and the practical arrangements necessary to implement Commission Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling...","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2016-03-07T12:00:00Z","reference_number":"EMA/CHMP/509951/2006, Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-scientific-application-and-practical-arrangements-necessary-implement-commission-regulation-ec-no-5072006-conditional-marketing-authorisation-medicinal-products-human-use-falling_en.pdf"},
    {"id":"40888","name":"Timetable for sending of translations to Croatia","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-08-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/timetable-sending-translations-croatia_en.pdf"},
    {"id":"40893","name":"Final list of references supporting the assessment of Matricaria recutita L., flos and Matricaria recutita L., aetheroleum","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2016-04-05T02:00:00Z","last_updated_date":"2016-04-05T02:00:00Z","reference_number":"EMA/HMPC/55810/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-matricaria-recutita-l-flos-and-matricaria-recutita-l-aetheroleum_en.pdf"},
    {"id":"40895","name":"CHMP summary of positive opinion for Xeplion","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/777632/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xeplion_en.pdf"},
    {"id":"40896","name":"Update on medicines containing valsartan from Zhejiang Tianyu","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-08-20T02:00:00Z","last_updated_date":"2018-08-20T02:00:00Z","reference_number":"EMA/562158/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-medicines-containing-valsartan-zhejiang-tianyu_en.pdf"},
    {"id":"40897","name":"Agenda - Symposium: Raw materials for production of cell-based and gene-therapy products","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T15:00:00Z","last_updated_date":"2013-01-28T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-symposium-raw-materials-production-cell-based-and-gene-therapy-products_en.pdf"},
    {"id":"40898","name":"Gentianae radix: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2000-01-01T01:00:00Z","last_updated_date":"2000-01-01T01:00:00Z","reference_number":"EMEA/MRL/716/99-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/gentianae-radix-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"40900","name":"CHMP opinion trends - first half of 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-09T11:30:00Z","last_updated_date":"2014-07-09T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-opinion-trends-first-half-2014_en.pdf"},
    {"id":"40902","name":"Guideline on immunogenicity assessment of therapeutic proteins - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2017-06-01T02:00:00Z","last_updated_date":"2017-06-01T02:00:00Z","reference_number":"EMEA/CHMP/BMWP/14327/2006 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf"},
    {"id":"40903","name":"Technical specification - Annex H: Financial identification form - EMA/2011/07/IF","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-08-01T02:00:00Z","last_updated_date":"2011-08-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-h-financial-identification-form-ema201107if_en.xls"},
    {"id":"40904","name":"EMEA Conference on Environmental Risk Assessment for Human and Veterinary Medicinal Products - 27-28 October 2005","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2005-10-28T02:00:00Z","last_updated_date":"2005-10-28T02:00:00Z","reference_number":"EMEA/359945/2005","document_url":"https://www.ema.europa.eu/en/documents/press-release/emea-conference-environmental-risk-assessment-human-and-veterinary-medicinal-products-27-28-october-2005_en.pdf"},
    {"id":"40905","name":"CHMP summary of positive opinion for Aripiprazole Sandoz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/387290/2015","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aripiprazole-sandoz_en.pdf"},
    {"id":"40908","name":"CHMP post-authorisation summary of positive opinion for Revinty Ellipta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-01-26T13:00:00Z","last_updated_date":"2018-01-26T13:00:00Z","reference_number":"EMA/CHMP/53722/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revinty-ellipta_en.pdf"},
    {"id":"40910","name":"EU/3/06/390: Public summary of positive opinion for orphan designation of 4-amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride for the treatment of moderate and severe traumatic brain injury","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-02-24T01:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMEA/COMP/275889/2006draft","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306390-public-summary-positive-opinion-orphan-designation-4-amino-6rs-5678-tetrahydro-l-biopterin-dihydrochloride-treatment-moderate-and-severe-traumatic-brain-injury_en.pdf"},
    {"id":"40911","name":"European Medicines Agency awards first 'ENCePP study' seal for post-marketing study","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-10-01T02:00:00Z","last_updated_date":"2010-10-01T02:00:00Z","reference_number":"EMA/613458/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-awards-first-encepp-study-seal-post-marketing-study_en.pdf"},
    {"id":"40913","name":"Ciclosporin IDL - Article-30 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-20T00:00:00Z","last_updated_date":"2013-11-20T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ciclosporin-idl-article-30-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"40915","name":"Overview of comments received on Community herbal monograph on Filipendula ulmaria (L.) Maxim., flos - First version","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-09-29T02:00:00Z","last_updated_date":"2011-09-29T02:00:00Z","reference_number":"EMA/HMPC/326673/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-filipendula-ulmaria-l-maxim-flos-first-version_en.pdf"},
    {"id":"40916","name":"Annual accounts: Financial year 2006","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2007-11-01T00:09:21Z","last_updated_date":"2007-11-01T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/annual-accounts-financial-year-2006_en.pdf"},
    {"id":"40920","name":"Venlafaxine:  List of nationally authorised medicinal products - PSUSA/00003104/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-15T16:15:00Z","last_updated_date":"2018-01-15T16:17:22Z","reference_number":"EMA/24903/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/venlafaxine-list-nationally-authorised-medicinal-products-psusa00003104201705_en.pdf"},
    {"id":"40921","name":"Novosis Goserelin - Article 36 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"EMEA/H/A-36/1295","document_url":"https://www.ema.europa.eu/en/documents/referral/novosis-goserelin-article-36-referral-assessment-report_en.pdf"},
    {"id":"40922","name":"EU/3/06/399: Public summary of positive opinion for orphan designation of mecasermin rinfabate for the prevention of retinopathy of prematurity in neonates of less than 32 weeks of gestational age","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2009-04-24T02:00:00Z","reference_number":"EMEA/COMP/63851/2008","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306399-public-summary-positive-opinion-orphan-designation-mecasermin-rinfabate-prevention-retinopathy-prematurity-neonates-less-32-weeks-gestational-age_en.pdf"},
    {"id":"40923","name":"CHMP summary of positive opinion for Leflunomide medac","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-05-21T02:00:00Z","last_updated_date":"2010-05-21T02:00:00Z","reference_number":"EMA/CHMP/291554/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-leflunomide-medac_en.pdf"},
    {"id":"40926","name":"EU/3/17/1951: Public summary of opinion on orphan designation: Agammaglobulinaemia tyrosine kinase for the treatment of pemphigus","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-24T10:44:00Z","last_updated_date":"2018-01-24T10:44:00Z","reference_number":"EMA/COMP/737372/2017 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171951-public-summary-opinion-orphan-designation-agammaglobulinaemia-tyrosine-kinase-treatment-pemphigus_en.pdf"},
    {"id":"40928","name":"Questions and answers on the referral for Bleomycin, powder for solution for injection, 15 U/Vial, from Pharmachemie BV","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2009-03-18T00:08:21Z","last_updated_date":"2009-03-18T00:08:21Z","reference_number":"EMEA/CHMP/191900/2009","document_url":"https://www.ema.europa.eu/en/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/questions-and-answers-referral-bleomycin-powder-solution-injection-15-uvial-pharmachemie-bv_sv.pdf"}},
    {"id":"40931","name":"Seasonique Article-29(4) - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-27T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/seasonique-article-294-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/seasonique-article-294-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/seasonique-article-294-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/seasonique-article-294-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/seasonique-article-294-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/seasonique-article-294-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/seasonique-article-294-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/seasonique-article-294-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/seasonique-article-294-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/seasonique-article-294-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/seasonique-article-294-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/seasonique-article-294-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/seasonique-article-294-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/seasonique-article-294-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/seasonique-article-294-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/seasonique-article-294-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/seasonique-article-294-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/seasonique-article-294-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/seasonique-article-294-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/seasonique-article-294-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/seasonique-article-294-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/seasonique-article-294-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/seasonique-article-294-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/seasonique-article-294-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/seasonique-article-294-annex-i_no.pdf"}},
    {"id":"40932","name":"Work programme of the European Medicines Agency 2017","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2017-02-14T11:50:00Z","last_updated_date":"2017-10-12T17:30:00Z","reference_number":"EMA/583016/2016 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-programme-european-medicines-agency-2017_en.pdf"},
    {"id":"40933","name":"EU/3/10/839: Public summary of opinion on orphan designation: Plitidepsin for the treatment of post-polycythaemia vera myelofibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-03-07T01:00:00Z","last_updated_date":"2011-09-06T02:00:00Z","reference_number":"EMA/COMP/740417/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310839-public-summary-opinion-orphan-designation-plitidepsin-treatment-post-polycythaemia-vera-myelofibrosis_en.pdf"},
    {"id":"40934","name":"EU/3/06/412: Public summary of positive opinion for orphan designation\n\nof 4,7,10,13,16,19-docosahexaenoic acid for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-02T02:00:00Z","last_updated_date":"2013-07-08T02:00:00Z","reference_number":"EMEA/COMP/197064/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306412-public-summary-positive-opinion-orphan-designation-4710131619-docosahexaenoic-acid-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"40935","name":"European Medicines Agency recommends action plan to deal with possible presence of endotoxins in Baxter peritoneal dialysis solutions","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/CHMP/825184/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-action-plan-deal-possible-presence-endotoxins-baxter-peritoneal-dialysis-solutions_en.pdf"},
    {"id":"40937","name":"SGLT2 inhibitors (previously canagliflozin) Article-20 procedure - Updated PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-07-08T17:00:00Z","last_updated_date":"2016-07-08T17:00:00Z","reference_number":"EMA/PRAC/472827/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/sglt2-inhibitors-previously-canagliflozin-article-20-procedure-updated-prac-list-questions_en.pdf"},
    {"id":"40939","name":"EU/3/11/897: Public summary of opinion on orphan designation: N-{[(5S)-3-(3-fluoro-4-thiomorpholin-4-ylphenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl}acetamide for the treatment of tuberculosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-09-21T02:00:00Z","last_updated_date":"2015-03-12T01:00:00Z","reference_number":"EMA/COMP/547013/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311897-public-summary-opinion-orphan-designation-n-5s-3-3-fluoro-4-thiomorpholin-4-ylphenyl-2-oxo-13-oxazolidin-5-ylmethylacetamide-treatment-tuberculosis_en.pdf"},
    {"id":"40940","name":"Questions and answers on Tysabri and liver injury","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2008-03-20T00:09:21Z","last_updated_date":"2008-03-20T00:09:21Z","reference_number":"EMEA/CHMP/145908/2008","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-tysabri-and-liver-injury_en.pdf"},
    {"id":"40943","name":"Opinion of the Committee on Herbal Medicinal Products on a European Union herbal monograph on Valeriana officinalis L., aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2016-04-27T12:00:00Z","last_updated_date":"2016-04-27T12:00:00Z","reference_number":"EMA/HMPC/74067/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-european-union-herbal-monograph-valeriana-officinalis-l-aetheroleum_en.pdf"},
    {"id":"40944","name":"Presentation - Public hearings (Francois Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-public-hearings-francois-houyez_en.pdf"},
    {"id":"40945","name":"Presentation - Field efficacy trials for vaccines for food-producing animals-challenges faced by industry  (F. Descamps)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-11-16T13:30:00Z","last_updated_date":"2017-11-16T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-field-efficacy-trials-vaccines-food-producing-animals-challenges-faced-industry-f-descamps_en.pdf"},
    {"id":"40946","name":"Superseded community herbal monograph on Echinacea purpurea (L.) Moench, radix - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-28T01:00:00Z","last_updated_date":"2011-01-28T01:00:00Z","reference_number":"EMA/HMPC/577784/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-echinacea-purpurea-l-moench-radix-first-version_en.pdf"},
    {"id":"40947","name":"Participants list - Third industry stakeholder platform on the operation of European Union pharmacovigilance legislation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-17T01:00:00Z","last_updated_date":"2015-03-17T01:00:00Z","reference_number":"EMA/177559/2015","document_url":"https://www.ema.europa.eu/en/documents/other/participants-list-third-industry-stakeholder-platform-operation-european-union-pharmacovigilance-legislation_en.pdf"},
    {"id":"40950","name":"Presentation - Feedback from the informal Heads of Medicines Agencies (HMA) meeting on 5th October 2011","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-10-28T02:00:00Z","last_updated_date":"2011-10-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-informal-heads-medicines-agencies-hma-meeting-5th-october-2011_en.pdf"},
    {"id":"40951","name":"EU/3/17/1944: Public summary of opinion on orphan designation: Tamoxifen citrate for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-01-15T01:00:00Z","last_updated_date":"2018-01-15T01:00:00Z","reference_number":"EMA/696120/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171944-public-summary-opinion-orphan-designation-tamoxifen-citrate-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"40952","name":"CHMP summary of positive opinion for Votrient","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-02-18T01:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"EMA/CHMP/104905/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-votrient_en.pdf"},
    {"id":"40954","name":"EU/3/05/319: Public summary of positive opinion for orphan designation of human Staphylococcus aureus immunoglobulin for the treatment of Staphylococcus aureus bacteraemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2008-08-18T02:00:00Z","last_updated_date":"2008-08-18T02:00:00Z","reference_number":"EMEA/COMP/317953/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu305319-public-summary-positive-opinion-orphan-designation-human-staphylococcus-aureus-immunoglobulin-treatment-staphylococcus-aureus-bacteraemia_en.pdf"},
    {"id":"40955","name":"Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-13T02:00:00Z","last_updated_date":"2016-10-17T16:05:50Z","reference_number":"EMA/677092/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/glatiramer-list-nationally-authorised-medicinal-products-psusa00001529201411_en.pdf"},
    {"id":"40956","name":"CHMP post-authorisation summary of positive opinion for Brivaness","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-02-18T01:00:00Z","last_updated_date":"2011-02-18T01:00:00Z","reference_number":"EMA/CHMP/131489/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-brivaness_en.pdf"},
    {"id":"40957","name":"Presentation - Session 4: What have we learnt from the anti PD1- PDL1 story? (Jorge Camarero )","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-07T01:00:00Z","last_updated_date":"2018-02-07T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-what-have-we-learnt-anti-pd1-pdl1-story-jorge-camarero_en.pdf"},
    {"id":"40961","name":"Semler Article-31 referral – Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/semler-article-31-referral-notification_en.pdf"},
    {"id":"40962","name":"European Medicines Agency sets out next steps on access to clinical-trial data","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2012-12-05T17:34:03Z","last_updated_date":"2012-12-05T17:34:03Z","reference_number":"EMA/775817/2012","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-sets-out-next-steps-access-clinical-trial-data_en.pdf"},
    {"id":"40963","name":"CHMP summary of positive opinion for Herzuma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T01:00:00Z","last_updated_date":"2017-12-15T01:00:00Z","reference_number":"EMA/CHMP/774782/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-herzuma_en.pdf"},
    {"id":"40964","name":"EU/3/10/817: Public summary of opinion on orphan designation: Adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin / adeno-associated viral vector containing a rhodopsin gene for the treatmen...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-01-19T01:00:00Z","last_updated_date":"2011-01-19T01:00:00Z","reference_number":"EMA/COMP/671325/2010","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu310817-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-containing-dna-encoding-rnai-targeting-rhodopsin-adeno-associated-viral-vector-containing-rhodopsin-gene-treatmen_en.pdf"},
    {"id":"40965","name":"Menarini International Operations Luxembourg withdraws its marketing authorisation application for Factive","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2009-06-23T02:00:00Z","last_updated_date":"2009-06-23T02:00:00Z","reference_number":"EMEA/382408/2009","document_url":"https://www.ema.europa.eu/en/documents/press-release/menarini-international-operations-luxembourg-withdraws-its-marketing-authorisation-application-factive_en.pdf"},
    {"id":"40968","name":"Work instructions for workflow of data entry to scientific-memory database","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2013-02-12T16:00:00Z","last_updated_date":"2013-02-12T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-workflow-data-entry-scientific-memory-database_en.pdf"},
    {"id":"40974","name":"Public statement on NeoSpect (depreotide): Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-neospect-depreotide-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"40977","name":"Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T15:45:00Z","last_updated_date":"2013-11-18T15:45:00Z","reference_number":"EMA/CVMP/AWP/119489/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-pleuromutilins-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf-0"},
    {"id":"40978","name":"Draft guideline on clinical investigation of medicinal products for the treatment of migraine","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-01-26T01:00:00Z","last_updated_date":"2006-01-26T01:00:00Z","reference_number":"CPMP/EWP/788/01 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-migraine_en.pdf"},
    {"id":"40980","name":"Announcement - Annual workshop on the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-12-19T15:45:00Z","last_updated_date":"2011-12-19T15:45:00Z","reference_number":"EMA/971491/2011","document_url":"https://www.ema.europa.eu/en/documents/other/announcement-annual-workshop-european-network-paediatric-research-european-medicines-agency-enpr-ema_en.pdf"},
    {"id":"40983","name":"CellCept: Product Information as approved by the CHMP on 22 October 2015, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cellcept-product-information-approved-chmp-22-october-2015-pending-endorsement-european-commission_en.pdf"},
    {"id":"40984","name":"Committee for Medicinal Products for Human Use (CHMP) - October 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-11-17T01:00:00Z","last_updated_date":"2005-11-17T01:00:00Z","reference_number":"EMEA/CHMP/362348/2005, rev.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-october-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"40988","name":"Adaptive pathways to patients: report on the initial experience of the pilot project","type":"report","status":"unknown","consultation_date":"","first_published_date":"2014-12-22T13:00:00Z","last_updated_date":"2014-12-22T13:00:00Z","reference_number":"EMA/758619/2014","document_url":"https://www.ema.europa.eu/en/documents/report/adaptive-pathways-patients-report-initial-experience-pilot-project_en.pdf"},
    {"id":"40989","name":"Questions and answers on recommendation for refusal of marketing application for Atryn","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2006-02-23T00:09:21Z","last_updated_date":"2006-02-23T00:09:21Z","reference_number":"EMEA/62022/2006","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-recommendation-refusal-marketing-application-atryn_en.pdf"},
    {"id":"40990","name":"EU/3/16/1687: Public summary of opinion on orphan designation: Recombinant protein derived from the saliva of the Ornithodoros moubata tick for the treatment of Guillain-Barrà© syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-07-26T02:00:00Z","last_updated_date":"2016-07-26T02:00:00Z","reference_number":"EMA/COMP/380759/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161687-public-summary-opinion-orphan-designation-recombinant-protein-derived-saliva-ornithodoros-moubata-tick-treatment-guillain-barrac-syndrome_en.pdf"},
    {"id":"40993","name":"Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-01-26T01:00:00Z","last_updated_date":"2017-01-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-xevmpd-face-face-training-course_en.pdf"},
    {"id":"40994","name":"Overview of comments on 'Reflection paper on clinical aspects related to tissue engineered products'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-12-11T16:30:00Z","last_updated_date":"2014-12-11T16:30:00Z","reference_number":"EMA/CAT/20938/2014","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-reflection-paper-clinical-aspects-related-tissue-engineered-products_en.pdf"},
    {"id":"40995","name":"Focus group on implementation of CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 (Phase I) and GL38 (Phase II) - Summary of the meeting held on 23...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-11-17T01:00:00Z","last_updated_date":"2008-11-17T01:00:00Z","reference_number":"EMEA/CVMP/ERA/106566/2008","document_url":"https://www.ema.europa.eu/en/documents/report/focus-group-implementation-cvmp-guideline-environmental-impact-assessment-veterinary-medicinal-products-support-vich-guidelines-gl6-phase-i-and-gl38-phase-ii-summary-meeting-held-23_en.pdf"},
    {"id":"40999","name":"Public statement on Riprazo: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2013-03-01T11:35:00Z","last_updated_date":"2013-03-01T11:35:00Z","reference_number":"EMA/103518/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-riprazo-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"41000","name":"CHMP summary of positive opinion for Plegridy","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/CHMP/276483/2014","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-plegridy_en.pdf"},
    {"id":"41001","name":"Agenda - Workshop on extrapolation of efficacy and safety in medicine development across age groups","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-01-14T17:50:00Z","last_updated_date":"2016-05-13T13:40:00Z","reference_number":"EMA/12429/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-extrapolation-efficacy-and-safety-medicine-development-across-age-groups_en.pdf"},
    {"id":"41002","name":"EU/3/02/089: Public summary of positive opinion for orphan designation of granulocyte macrophage colony stimulating factor receptor antagonist for the treatment of juvenile myelomonocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2005-11-29T00:00:00Z","last_updated_date":"2005-11-29T00:00:00Z","reference_number":"EMEA/COMP/67/02 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu302089-public-summary-positive-opinion-orphan-designation-granulocyte-macrophage-colony-stimulating-factor-receptor-antagonist-treatment-juvenile-myelomonocytic-leukaemia_en.pdf"},
    {"id":"41005","name":"CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Revised after second teleconference with comments","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag1-advice-european-medicines-agency-clinical-trial-advisory-group-protecting-patient-confidentiality-revised-after-second-teleconference-comments_en.pdf"},
    {"id":"41006","name":"Withdrawal assessment report for Ertapenem Hospira","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-12-06T01:00:00Z","last_updated_date":"2016-12-06T01:00:00Z","reference_number":"EMA/620892/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ertapenem-hospira_en.pdf"},
    {"id":"41007","name":"Start of Community reviews - CHMP meeting of 16-19 September 2013","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-20T14:00:05Z","last_updated_date":"2013-09-20T14:00:05Z","reference_number":"EMA/565898/2013","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-16-19-september-2013_en.pdf"},
    {"id":"41009","name":"Committee for medicinal products for human use summary of positive opinion for Firazyr","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-04-28T02:09:21Z","last_updated_date":"2008-04-28T02:09:21Z","reference_number":"EMEA/CHMP/197104/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-firazyr_en.pdf"},
    {"id":"41012","name":"HPV vaccines - Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-07-13T02:00:00Z","last_updated_date":"2015-07-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/hpv-vaccines-article-20-procedure-notification_en.pdf"},
    {"id":"41013","name":"Committee for Medicinal Products for Human Use (CHMP) - September 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-09-28T02:00:00Z","last_updated_date":"2005-09-28T02:00:00Z","reference_number":"EMEA/CHMP/295298/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-september-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"41014","name":"Testosterone Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T14:00:00Z","last_updated_date":"2014-04-11T14:00:00Z","reference_number":"EMA/209962/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/testosterone-article-31-referral-review-started_en.pdf"},
    {"id":"41018","name":"Perindopril: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002354/201510","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-08-05T12:00:00Z","last_updated_date":"2016-10-17T16:59:46Z","reference_number":"EMA/528822/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/perindopril-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002354201510_en.pdf"},
    {"id":"41019","name":"Questions and answers on the outcome of an extension of indication application for Lysodren (mitotane)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T14:00:00Z","last_updated_date":"2013-05-31T14:00:00Z","reference_number":"EMA/323929/2013","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-extension-indication-application-lysodren-mitotane_en.pdf"},
    {"id":"41020","name":"Draft guideline on clinical trials with haemopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2006-04-27T02:09:21Z","last_updated_date":"2006-04-27T02:09:21Z","reference_number":"CPMP/EWP/555/95 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-trials-haemopoietic-growth-factors-prophylaxis-infection-following-myelosuppressive-or-myeloablative-therapy_en.pdf"},
    {"id":"41021","name":"CTAG3: Clinical Trial Advisory Group on rules of engagement - Membership overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-04-30T16:30:00Z","last_updated_date":"2013-04-30T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ctag3-clinical-trial-advisory-group-rules-engagement-membership-overview_en.pdf"},
    {"id":"41023","name":"EU/3/18/1974: Public summary of opinion on orphan designation: 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate for the treatment of acute ...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-04-10T02:00:00Z","last_updated_date":"2018-04-10T02:00:00Z","reference_number":"EMA/65622/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3181974-public-summary-opinion-orphan-designation-6-1r2s-2-aminocyclohexylamino-7-fluoro-4-1-methyl-1h-pyrazol-4-yl-12-dihydro-3h-pyrrolo34-cpyridin-3-one-monocitrate-treatment-acute_en.pdf"},
    {"id":"41025","name":"CVMP summary of positive opinion for Fungitraxx","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-01-17T01:00:00Z","last_updated_date":"2014-01-17T01:00:00Z","reference_number":"EMA/CVMP/715528/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-fungitraxx_en.pdf"},
    {"id":"41026","name":"Fenvalerate: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2004-03-01T01:00:00Z","last_updated_date":"2004-03-01T01:00:00Z","reference_number":"EMEA/MRL/899/04-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/fenvalerate-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"41027","name":"CVMP post-authorisation summary of positive opinion for Rheumocam","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2011-03-11T01:00:00Z","last_updated_date":"2011-03-11T01:00:00Z","reference_number":"EMA/CVMP/9999/2011","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-rheumocam_en.pdf-3"},
    {"id":"41029","name":"Overview of comments received on ‘Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance’","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T16:42:00Z","last_updated_date":"2017-01-03T16:42:00Z","reference_number":"EMA/CHMP/620299/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-everolimus-tablets-025-mg-05-mg-075-mg-and-1-mg-25-mg-5-mg-and-10-mg-dispersible-tablets-01-mg-and-025-mg-2-mg-3-mg-and-5-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"41032","name":"Superseded list of references supporting the assessment report on Echinaceae pallidae Radix Echinacea pallida (Nutt.) Nutt., radix (pale coneflower root)","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2009-07-16T02:09:21Z","last_updated_date":"2018-08-14T02:09:21Z","reference_number":"EMEA/HMPC/332366/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-list-references-supporting-assessment-report-echinaceae-pallidae-radix-echinacea-pallida-nutt-nutt-radix-pale-coneflower-root_en.pdf"},
    {"id":"41037","name":"Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2014-08-19T16:30:00Z","last_updated_date":"2019-06-18T10:16:00Z","reference_number":"EMA/135540/2019 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/recommendations-implementation-exemptions-labelling-and-package-leaflet-obligations-centralised-procedure_en.pdf"},
    {"id":"41038","name":"Presentation - Commission call on patient and healthcare representatives for PRAC and CAT (Florian Schmidt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-11-27T13:00:00Z","last_updated_date":"2012-11-27T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-commission-call-patient-and-healthcare-representatives-prac-and-cat-florian-schmidt_en.pdf"},
    {"id":"41039","name":"Dimetridazole: Summary report (1) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1996-05-05T02:00:00Z","last_updated_date":"1996-05-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/dimetridazole-summary-report-1-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"41040","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 23 – 26 January 2017","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T13:00:00Z","last_updated_date":"2017-01-27T13:00:00Z","reference_number":"EMA/CHMP/SAWP/59168/2017","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-23-26-january-2017_en.pdf"},
    {"id":"41045","name":"Day 80 assessment report - Clinical guidance","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-09-01T02:09:21Z","last_updated_date":"2014-05-28T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/day-80-assessment-report-clinical-guidance_en.pdf"},
    {"id":"41047","name":"Exubera inhalation powder, pre-dispensed (2 and 3 mg): Notice of intension to cease marketing of product - Letter","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-11-19T00:09:21Z","last_updated_date":"2007-11-19T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/exubera-inhalation-powder-pre-dispensed-2-and-3-mg-notice-intension-cease-marketing-product-letter_en.pdf"},
    {"id":"41049","name":"Sorafenib film-coated tablets 200 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/315232/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/sorafenib-film-coated-tablets-200-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"41050","name":"Introduction of ECHAMP (European Coalition on Homeopathic and\n\nAnthroposophic Medicinal Products)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2006-10-27T02:09:21Z","last_updated_date":"2006-10-27T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-echamp-european-coalition-homeopathic-and-anthroposophic-medicinal-products_en.pdf"},
    {"id":"41052","name":"Questions and answers on the withdrawal of the marketing authorisation application for Qizenday (biotin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2017-12-14T01:00:00Z","last_updated_date":"2018-02-06T01:00:00Z","reference_number":"EMA/821654/2017","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-qizenday-biotin_sv.pdf"}},
    {"id":"41055","name":"CHMP summary of opinion for Pemetrexed Fresenius Kabi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-05-27T02:00:00Z","last_updated_date":"2016-05-27T02:00:00Z","reference_number":"EMA/CHMP/337417/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-pemetrexed-fresenius-kabi_en.pdf"},
    {"id":"41056","name":"Agenda - Workshop on Medicines for the Treatment of Pain in children","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2004-10-27T02:09:21Z","last_updated_date":"2004-10-27T02:09:21Z","reference_number":"EMEA/8957/04","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-medicines-treatment-pain-children_en.pdf"},
    {"id":"41060","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T13:00:00Z","last_updated_date":"2020-06-09T13:00:00Z","reference_number":"EMA/COMP/766700/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-ofev-nintedanib-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"41062","name":"Caryophylli aetheroleum: Summary report - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"1998-05-01T02:00:00Z","last_updated_date":"1998-05-01T02:00:00Z","reference_number":"EMEA/MRL/406/98-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/caryophylli-aetheroleum-summary-report-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"41063","name":"Presentation - Introduction: summary of product characteristics (SmPC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-09-06T13:00:00Z","last_updated_date":"2017-09-06T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-summary-product-characteristics-smpc_en.pdf"},
    {"id":"41064","name":"Presentation - Immunogenicity guideline monoclonal antibodies - A risk-based approach - rationale and decision points","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-06-15T17:10:57Z","last_updated_date":"2012-06-15T17:10:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-immunogenicity-guideline-monoclonal-antibodies-risk-based-approach-rationale-and-decision-points_en.pdf"},
    {"id":"41066","name":"Presentation - Treatment of serious infections due to multiple drug resistant (MDR) acinetobacter baumannii: Presentation of a multicenter randomised clinical trial (Riccardo Utili)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-treatment-serious-infections-due-multiple-drug-resistant-mdr-acinetobacter-baumannii-presentation-multicenter-randomised-clinical-trial-riccardo-utili_en.pdf"},
    {"id":"41067","name":"FP7 and off patent medicines developed for children - Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2007-06-06T02:09:21Z","last_updated_date":"2007-06-06T02:09:21Z","reference_number":"EMEA/254655/2007","document_url":"https://www.ema.europa.eu/en/documents/report/fp7-and-patent-medicines-developed-children-report_en.pdf"},
    {"id":"41068","name":"Concept paper on preparation of a guideline on the evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infection - First version","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2016-10-26T16:27:00Z","last_updated_date":"2016-10-26T16:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-preparation-guideline-evaluation-medicinal-products-indicated-treatment-and-prophylaxis-respiratory-syncytial-virus-rsv-infection-first-version_en.pdf"},
    {"id":"41069","name":"Presentation - PDCO feedback (D. Athanasiou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:50:00Z","last_updated_date":"2017-12-11T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-feedback-d-athanasiou_en.pdf"},
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    {"id":"41072","name":"Dexamed and associated names Article-29(4) referral - Questions and answers","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-09-02T02:00:00Z","reference_number":"EMA/709170/2013","document_url":"https://www.ema.europa.eu/en/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/dexamed-and-associated-names-article-294-referral-questions-and-answers_sv.pdf"}},
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    {"id":"41074","name":"Oxyclozanide: Summary report (2) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2002-01-01T01:00:00Z","last_updated_date":"2002-01-01T01:00:00Z","reference_number":"EMEA/MRL/817/02-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/oxyclozanide-summary-report-2-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"41075","name":"Withdrawal assessment report for Tigecycline Accord","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-10-10T02:00:00Z","last_updated_date":"2017-10-10T02:00:00Z","reference_number":"EMA/CHMP/663395/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tigecycline-accord_en.pdf"},
    {"id":"41078","name":"Presentation - Pharmacovigilance in paediatric population - The PRAC's perspective (June Raine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-05-16T02:00:00Z","last_updated_date":"2014-05-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-paediatric-population-pracs-perspective-june-raine_en.pdf"},
    {"id":"41079","name":"Alzheimer's disease - Target population and development of biomarkers - Harald Hampel","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2008-02-11T00:09:21Z","last_updated_date":"2008-02-11T00:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/alzheimers-disease-target-population-and-development-biomarkers-harald-hampel_en.pdf"},
    {"id":"41081","name":"Presentation - Optimising the guidance on significant benefit demonstration in the context of protocol assistance (Matthias Hofer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T18:21:00Z","last_updated_date":"2017-05-12T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-optimising-guidance-significant-benefit-demonstration-context-protocol-assistance-matthias-hofer_en.pdf"},
    {"id":"41082","name":"Goserelin Cell Pharm - Article 36 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-02-06T01:00:00Z","last_updated_date":"2012-02-06T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/goserelin-cell-pharm-article-36-referral-annex-i_sv.pdf"}},
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    {"id":"41085","name":"Committee for veterinary medicinal products: 59th meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-10-12T14:49:21Z","last_updated_date":"2000-10-12T14:49:21Z","reference_number":"EMEA/CVMP/773/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-veterinary-medicinal-products-59th-meeting_en.pdf"},
    {"id":"41086","name":"Presentation - National experience of application of the requirements for marketing authorisations - considering the situation with detachment (Jean-Claude Rouby)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-04-29T14:00:00Z","last_updated_date":"2015-04-29T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-national-experience-application-requirements-marketing-authorisations-considering-situation-detachment-jean-claude-rouby_en.pdf"},
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    {"id":"41090","name":"Start of community reviews - CHMP meeting of 19-22 May 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-05-23T02:00:00Z","last_updated_date":"2014-05-23T02:00:00Z","reference_number":"EMA/308394/2014","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-19-22-may-2014_en.pdf"},
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    {"id":"41094","name":"Abciximab: List of nationally authorised medicinal products - PSUSA/00000014/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-19T12:55:00Z","last_updated_date":"2018-07-19T12:55:00Z","reference_number":"EMA/495549/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/abciximab-list-nationally-authorised-medicinal-products-psusa00000014201711_en.pdf"},
    {"id":"41097","name":"European Medicines Agency adopts a positive opinion for the use of Prozac in the treatment of children and adolescents suffering from depression","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2006-06-06T02:09:21Z","last_updated_date":"2006-06-06T02:09:21Z","reference_number":"EMEA/202554/2006","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-adopts-positive-opinion-use-prozac-treatment-children-and-adolescents-suffering-depression_en.pdf"},
    {"id":"41098","name":"Veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk 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    {"id":"41141","name":"Guido Rasi - Biography","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-10-01T02:00:00Z","last_updated_date":"2015-11-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/guido-rasi-biography_en.pdf"},
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    {"id":"41145","name":"Presentation - Day 2: Intraocular Inflammation regulatory views","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2011-11-15T13:00:00Z","last_updated_date":"2011-11-15T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-day-2-intraocular-inflammation-regulatory-views_en.pdf"},
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    {"id":"41148","name":"Rabbit anti-human thymocyte (powder for solution for\n\ninfusion): CMDh scientific conclusions and grounds for variation,\n\namendments to the product information and timetable for\n\nthe implementation - PSUSA/00010184/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-09-04T12:00:00Z","last_updated_date":"2016-10-17T19:31:36Z","reference_number":"EMA/592371/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabbit-anti-human-thymocyte-powder-solution-infusion-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00010184201412_en.pdf-0"},
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    {"id":"41152","name":"EU/3/17/1844: Public summary of opinion on orphan designation: Tauroursodeoxycholic acid for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-03-31T02:00:00Z","last_updated_date":"2017-03-31T02:00:00Z","reference_number":"EMA/72424/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171844-public-summary-opinion-orphan-designation-tauroursodeoxycholic-acid-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
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    {"id":"41154","name":"IPA selected activities, S Benefice, EMA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/ipa-selected-activities-s-benefice-ema_en.pdf"},
    {"id":"41155","name":"First HDAC inhibitor for treatment of multiple myeloma recommended for approval in EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-06-26T02:00:00Z","last_updated_date":"2015-06-26T02:00:00Z","reference_number":"EMA/CHMP/423123/2015 Corr 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-hdac-inhibitor-treatment-multiple-myeloma-recommended-approval-eu_en.pdf"},
    {"id":"41156","name":"Organisational matters - CHMP meeting 21-24 July 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-07-29T18:15:00Z","last_updated_date":"2014-07-29T18:15:00Z","reference_number":"EMA/125409/2014","document_url":"https://www.ema.europa.eu/en/documents/other/organisational-matters-chmp-meeting-21-24-july-2014_en.pdf"},
    {"id":"41158","name":"Meeting report from the second ENCePP meeting with Centres at the EMEA (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2008-10-03T02:00:00Z","last_updated_date":"2008-10-03T02:00:00Z","reference_number":"EMEA/299086/2008","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-second-encepp-meeting-centres-emea-european-network-centres-pharmacoepidemiology-and-pharmacovigilance_en.pdf"},
    {"id":"41159","name":"Etifoxine: List of nationally authorised medicinal products - PSUSA/00001321/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-06-15T18:00:00Z","last_updated_date":"2018-06-15T18:00:00Z","reference_number":"EMA/374606/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/etifoxine-list-nationally-authorised-medicinal-products-psusa00001321201710_en.pdf"},
    {"id":"41160","name":"Committee for Medicinal Products for Human Use (CHMP) - July 2005 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2005-08-04T02:00:00Z","last_updated_date":"2005-08-04T02:00:00Z","reference_number":"EMEA/CHMP/229460/2005","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-july-2005-plenary-meeting-monthly-report_en.pdf"},
    {"id":"41162","name":"Presentation - Overview of European Medicines Agency’s interaction with patients and consumers organisations - 2014 (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-european-medicines-agencys-interaction-patients-and-consumers-organisations-2014-nathalie-bere_en.pdf"},
    {"id":"41163","name":"Concept paper for the revision of the guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Revision 2","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-10-23T02:00:00Z","last_updated_date":"2012-10-23T02:00:00Z","reference_number":"EMA/CVMP/EWP/290691/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestations-dogs-and-cats-revision-2_en.pdf"},
    {"id":"41164","name":"CHMP positive summary of opinion for Daxas","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-04-23T02:00:00Z","last_updated_date":"2010-04-23T02:00:00Z","reference_number":"EMA/CHMP/159861/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-positive-summary-opinion-daxas_en.pdf"},
    {"id":"41165","name":"Standard operating procedure for CHMP rapporteur / co-rapporteur appointment for Community procedures","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2009-02-11T01:00:00Z","last_updated_date":"2012-09-26T18:36:00Z","reference_number":"SOP/H/3176","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-chmp-rapporteur-co-rapporteur-appointment-community-procedures_en.pdf"},
    {"id":"41168","name":"Diclofenac Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2013-11-27T01:00:00Z","last_updated_date":"2013-11-27T01:00:00Z","reference_number":"EMEA/H/A-31/1344","document_url":"https://www.ema.europa.eu/en/documents/referral/diclofenac-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/diclofenac-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/diclofenac-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/diclofenac-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/diclofenac-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/diclofenac-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/diclofenac-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/diclofenac-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/diclofenac-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/diclofenac-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/diclofenac-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/diclofenac-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/diclofenac-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/diclofenac-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/diclofenac-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/diclofenac-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/diclofenac-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/diclofenac-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/diclofenac-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/diclofenac-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/diclofenac-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/diclofenac-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/diclofenac-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"41172","name":"EU/3/01/047: Public summary of positive opinion for orphan designation of thalidomide for the treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-10-15T02:00:00Z","last_updated_date":"2009-10-15T02:00:00Z","reference_number":"EMEA/COMP/11249/2003 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu301047-public-summary-positive-opinion-orphan-designation-thalidomide-treatment-multiple-myeloma_en.pdf"},
    {"id":"41173","name":"EudraVigilance registration system: Introduction of new functionalities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-17T17:00:00Z","last_updated_date":"2016-06-17T17:00:00Z","reference_number":"EMA/410776/2016","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-registration-system-introduction-new-functionalities_en.pdf"},
    {"id":"41174","name":"Qualified Person’s declaration concerning good manufacturing practice (GMP) compliance of the active substance manufacture “The QP declaration template”","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2014-06-04T12:10:00Z","last_updated_date":"2014-06-04T12:10:00Z","reference_number":"EMA/334808/2014","document_url":"https://www.ema.europa.eu/en/documents/template-form/qualified-persons-declaration-concerning-good-manufacturing-practice-gmp-compliance-active-substance-manufacture-qp-declaration-template_en.doc"},
    {"id":"41177","name":"Technical requirements for Annex I - Patrick Celis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-04-03T02:09:21Z","last_updated_date":"2009-04-03T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/technical-requirements-annex-i-patrick-celis_en.pdf"},
    {"id":"41178","name":"Final assessment report on Glycine max (L.) Merr., oleum\n\nraffinatum","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2017-03-03T10:19:00Z","last_updated_date":"2017-03-03T10:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-glycine-max-l-merr-oleum-raffinatum_en.pdf"},
    {"id":"41181","name":"Presentation - Fee system of the European Medicines Agency: Ensuring long-term sustainability","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-13T01:00:00Z","last_updated_date":"2010-12-13T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fee-system-european-medicines-agency-ensuring-long-term-sustainability_en.pdf"},
    {"id":"41182","name":"Reduction of antimicrobial use and resistance: Any other options than reducing triggers for bacterial disease? - Klaus Hellmann","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-05-19T02:00:00Z","last_updated_date":"2009-05-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/reduction-antimicrobial-use-and-resistance-any-other-options-reducing-triggers-bacterial-disease-klaus-hellmann_en.pdf"},
    {"id":"41185","name":"CHMP summary of positive opinion for Xeljanz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T13:00:00Z","last_updated_date":"2017-01-27T13:00:00Z","reference_number":"EMA/CHMP/32752/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xeljanz_en.pdf"},
    {"id":"41187","name":"EudraVigilance Information Day, 19 October 2010 - Agenda and registration form","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-10-01T02:00:00Z","last_updated_date":"2010-10-01T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-information-day-19-october-2010-agenda-and-registration-form_en.pdf"},
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    {"id":"41210","name":"Final Assessment report on Juniperus communis L., aetheroleum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2011-06-27T02:00:00Z","last_updated_date":"2011-06-27T02:00:00Z","reference_number":"EMA/HMPC/12401/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-juniperus-communis-l-aetheroleum_en.pdf"},
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    {"id":"41234","name":"Public statement on Uprima: Non-renewal of marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2006-05-29T02:00:00Z","last_updated_date":"2006-05-29T02:00:00Z","reference_number":"EMEA/186645/2006","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-uprima-non-renewal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"41239","name":"EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T02:00:00Z","last_updated_date":"2017-06-23T02:00:00Z","reference_number":"EMA/381688/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-symbioflor-2-can-continue-be-used-irritable-bowel-syndrome_en.pdf"},
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    {"id":"41273","name":"CHMP summary of positive opinion for Mavenclad","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-06-23T14:00:00Z","last_updated_date":"2017-06-23T14:00:00Z","reference_number":"EMA/CHMP/364898/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mavenclad_en.pdf"},
    {"id":"41276","name":"Furosemide / spironolactone : List of nationally authorised medicinal products - PSUSA/00001493/201612","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-09-08T11:44:00Z","last_updated_date":"2017-09-08T11:48:42Z","reference_number":"EMA/593213/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/furosemide-spironolactone-list-nationally-authorised-medicinal-products-psusa00001493201612_en.pdf"},
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    {"id":"41280","name":"EU/3/04/197: Public summary of positive opinion for orphan designation of treprostinil sodium (inhalation use) for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2009-09-23T02:00:00Z","reference_number":"EMEA/COMP/137/04 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu304197-public-summary-positive-opinion-orphan-designation-treprostinil-sodium-inhalation-use-treatment-pulmonary-arterial-hypertension-and-chronic-thromboembolic-pulmonary-hypertension_en.pdf"},
    {"id":"41281","name":"Workshop on the development of an EMEA transparency policy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2009-01-23T01:00:00Z","last_updated_date":"2009-01-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/workshop-development-emea-transparency-policy_en.pdf"},
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    {"id":"41285","name":"Recommendation for maintenance of orphan designation at the time of marketing authorisation: Alprolix (eftrenonacog alfa) for the treatment of haemophilia B","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2016-05-30T02:00:00Z","reference_number":"EMA/COMP/259512/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-alprolix-eftrenonacog-alfa-treatment-haemophilia-b_en.pdf"},
    {"id":"41286","name":"Inaugural meeting of the Committee for Orphan Medicinal Products","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2000-04-19T02:00:00Z","last_updated_date":"2000-04-19T02:00:00Z","reference_number":"EMEA/COMP/5/00","document_url":"https://www.ema.europa.eu/en/documents/press-release/inaugural-meeting-committee-orphan-medicinal-products_en.pdf"},
    {"id":"41287","name":"CHMP post-authorisation summary of positive opinion for Cymbalta on 26 June 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-06-26T02:00:00Z","last_updated_date":"2008-06-26T02:00:00Z","reference_number":"EMEA/CHMP/335965/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cymbalta-26-june-2008_en.pdf"},
    {"id":"41292","name":"Draft guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2007-11-15T01:00:00Z","last_updated_date":"2007-11-15T01:00:00Z","reference_number":"EMEA/CHMP/EWP/517497/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-medicinal-products-used-weight-control-addendum-weight-control-children_en.pdf"},
    {"id":"41295","name":"Presentation - Pharmacovigilance: Vision and needs for the future (Karen Quine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-26T12:00:00Z","last_updated_date":"2014-03-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-vision-and-needs-future-karen-quine_en.pdf"},
    {"id":"41298","name":"Nafcillin (Extension to all ruminants): Summary report (3) - Committee for Veterinary Medicinal Products","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2003-11-01T01:00:00Z","last_updated_date":"2003-11-01T01:00:00Z","reference_number":"EMEA/MRL/887/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/nafcillin-extension-all-ruminants-summary-report-3-committee-veterinary-medicinal-products_en.pdf"},
    {"id":"41299","name":"Presentation - Non-interventional post-authorisation safety studies: Definition, obligations and requirements (A. Rubino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-28T12:00:00Z","last_updated_date":"2013-01-28T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-interventional-post-authorisation-safety-studies-definition-obligations-and-requirements-rubino_en.pdf"},
    {"id":"41301","name":"Minutes of the EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (20 September 2016)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-01-03T01:00:00Z","last_updated_date":"2017-01-03T01:00:00Z","reference_number":"EMA/625038/2016","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-20-september-2016_en.pdf"},
    {"id":"41302","name":"Final Opinion of the committee on herbal medicinal products on a  European Union herbal monograph on Echinacea purpurea (L.) Moench., herba recens","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2015-04-13T02:00:00Z","last_updated_date":"2015-04-13T02:00:00Z","reference_number":"EMA/HMPC/712219/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-committee-herbal-medicinal-products-european-union-herbal-monograph-echinacea-purpurea-l-moench-herba-recens_en.pdf"},
    {"id":"41304","name":"Points to consider on switching between superiority and non-inferiority","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2000-07-27T02:00:00Z","last_updated_date":"2000-07-27T02:00:00Z","reference_number":"CPMP/EWP/482/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-switching-between-superiority-and-non-inferiority_en.pdf"},
    {"id":"41306","name":"Implementation of the framework for interaction between the European Medicines Agency and healthcare professionals - Progress report 2012","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/implementation-framework-interaction-between-european-medicines-agency-and-healthcare-professionals-progress-report-2012_en.pdf"},
    {"id":"41307","name":"Superseded opinion of the committee on herbal medicinal products on a community herbal monograph on Primula veris L., Primula elatior (L.) Hill, flos","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2010-04-09T02:00:00Z","last_updated_date":"2010-04-09T02:00:00Z","reference_number":"EMA/HMPC/405544/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-primula-veris-l-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"41308","name":"Presentation -  Avenues of knowledge generation throughout a medicine’s lifespan: methodological issues (Rob Hemmings)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-21T10:16:00Z","last_updated_date":"2016-12-21T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-avenues-knowledge-generation-throughout-medicines-lifespan-methodological-issues-rob-hemmings_en.pdf"},
    {"id":"41310","name":"EU/3/06/397: Public summary of positive opinion for orphan designation of cholest-4-en-3-one, oxime for treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2009-04-24T02:00:00Z","last_updated_date":"2013-10-17T02:00:00Z","reference_number":"EMEA/COMP/279844/2006 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu306397-public-summary-positive-opinion-orphan-designation-cholest-4-en-3-one-oxime-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"41311","name":"Work instructions for announcement of good-clinical-practice / pharmacovigilance inspection to reporting inspectorate, applicant and third-country inspectorate prepared by the Section for Clinical and Non-clinical Compli...","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2012-09-28T12:00:00Z","last_updated_date":"2012-09-28T12:00:00Z","reference_number":"WIN/INSP/2025","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-announcement-good-clinical-practice-pharmacovigilance-inspection-reporting-inspectorate-applicant-and-third-country-inspectorate-prepared-section-clinical-and-non-clinical-compli_en.pdf"},
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    {"id":"41314","name":"Presentation - The challenges of Personalised Medicine: Contributions from the Research Infrastructures (Jan-Eric Litton)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T02:00:00Z","last_updated_date":"2016-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-personalised-medicine-contributions-research-infrastructures-jan-eric-litton_en.pdf"},
    {"id":"41315","name":"Codeine Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-04-11T02:00:00Z","last_updated_date":"2014-04-11T02:00:00Z","reference_number":"EMA/209409/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/codeine-article-31-referral-review-started_en.pdf-0"},
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    {"id":"41317","name":"Summary of transfer of appropriations in the budget 2012 - Management Board meeting: 13 December 2012","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2012-12-20T01:00:00Z","last_updated_date":"2012-12-20T01:00:00Z","reference_number":"EMA/MB/724367/2012","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2012-management-board-meeting-13-december-2012_en.pdf"},
    {"id":"41318","name":"Presentation - Case study 1 - Application of prior knowledge for process parameter definition - Session 3 (Bob Kuhn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T01:00:00Z","last_updated_date":"2017-12-01T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-1-application-prior-knowledge-process-parameter-definition-session-3-bob-kuhn_en.pdf"},
    {"id":"41320","name":"Ex vivo expanded autologous Epstein-Barr Virus specific T-cells derived from peripheral blood mononuclear cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2016-05-04T13:00:00Z","reference_number":"EMA/291907/2016","document_url":"https://www.ema.europa.eu/en/documents/report/ex-vivo-expanded-autologous-epstein-barr-virus-specific-t-cells-derived-peripheral-blood-mononuclear-cells_en.pdf"},
    {"id":"41321","name":"EU/3/14/1394: Public summary of positive opinion for orphan designation: Pegylated recombinant human hyaluronidase PH20 for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T18:00:00Z","last_updated_date":"2015-02-26T18:00:00Z","reference_number":"EMA/COMP/733378/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141394-public-summary-positive-opinion-orphan-designation-pegylated-recombinant-human-hyaluronidase-ph20-treatment-pancreatic-cancer_en.pdf"},
    {"id":"41322","name":"Committee for Medicinal Products for Human Use (CHMP) -  November 2006 plenary meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2006-11-29T01:00:00Z","last_updated_date":"2006-11-29T01:00:00Z","reference_number":"EMEA/484273/2006","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-medicinal-products-human-use-chmp-november-2006-plenary-meeting-monthly-report_en.pdf"},
    {"id":"41323","name":"Technical specification - Annex 14 - External service providers for software applications EMA/2012/13/ICT","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-01-03T10:00:00Z","last_updated_date":"2013-02-15T16:30:00Z","reference_number":"EMA/747973/2012","document_url":"https://www.ema.europa.eu/en/documents/other/technical-specification-annex-14-external-service-providers-software-applications-ema201213ict_en.xls"},
    {"id":"41325","name":"Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"41326","name":"European Medicines Agency recommends withdrawal of the marketing authorisations for lumiracoxib-containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2007-12-13T01:00:00Z","last_updated_date":"2007-12-13T01:00:00Z","reference_number":"EMEA/CHMP/579301/2007","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-withdrawal-marketing-authorisations-lumiracoxib-containing-medicines_en.pdf"},
    {"id":"41327","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-11-18T16:05:00Z","last_updated_date":"2016-11-18T16:05:00Z","reference_number":"EMA/CAT/675972/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-november-2016_en.pdf"},
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    {"id":"41329","name":"EU/3/11/880: Public summary of opinion on orphan designation: Genetically modified human adenovirus encoding human PH20 hyaluronidase for the treatment of pancreatic cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2011-07-12T02:00:00Z","last_updated_date":"2013-07-31T12:15:00Z","reference_number":"EMA/COMP/309860/2011","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu311880-public-summary-opinion-orphan-designation-genetically-modified-human-adenovirus-encoding-human-ph20-hyaluronidase-treatment-pancreatic-cancer_en.pdf"},
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    {"id":"41338","name":"Withdrawal assessment report for Somnena","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-09-14T02:00:00Z","last_updated_date":"2017-09-14T02:00:00Z","reference_number":"EMA/CVMP/636012/2016","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-somnena_en.pdf"},
    {"id":"41339","name":"COMP meeting report on the review of applications for orphan designation: April 2016","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-04-27T19:30:00Z","last_updated_date":"2016-04-27T19:30:00Z","reference_number":"EMA/COMP/225346/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-april-2016_en.pdf"},
    {"id":"41341","name":"EudraVigilance status report 2009 (veterinary)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2014-10-08T15:00:00Z","reference_number":"EMA/13787/2009","document_url":"https://www.ema.europa.eu/en/documents/report/eudravigilance-status-report-2009-veterinary_en.pdf"},
    {"id":"41342","name":"Presentation - Specific issues that research ethics committees face with paediatric trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-01-16T11:00:00Z","last_updated_date":"2012-01-16T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-specific-issues-research-ethics-committees-face-paediatric-trials_en.pdf"},
    {"id":"41343","name":"Workshop: In vitro Cytokine release assays; To predict Cytokine release syndrome: The current state-of-the-science - Announcement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-07-14T02:09:21Z","last_updated_date":"2009-07-14T02:09:21Z","reference_number":"EMEA/367714/2009","document_url":"https://www.ema.europa.eu/en/documents/other/workshop-vitro-cytokine-release-assays-predict-cytokine-release-syndrome-current-state-science-announcement_en.pdf"},
    {"id":"41344","name":"Human autologous stromal vascular fraction cells and human autologous adipose-derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2016-11-15T16:33:00Z","last_updated_date":"2016-11-15T16:33:00Z","reference_number":"EMA/693827/2016","document_url":"https://www.ema.europa.eu/en/documents/report/human-autologous-stromal-vascular-fraction-cells-and-human-autologous-adipose-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"41347","name":"Presentation - Proposal for guidance on medical research for and with older people in Europe","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2012-04-10T14:00:00Z","last_updated_date":"2012-04-10T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-guidance-medical-research-and-older-people-europe_en.pdf"},
    {"id":"41349","name":"Clinical trials in paediatric pain treatment - Katri Hamunen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2004-10-28T02:09:21Z","last_updated_date":"2004-10-28T02:09:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/clinical-trials-paediatric-pain-treatment-katri-hamunen_en.pdf"},
    {"id":"41350","name":"EMA confirms recommendations to minimise risk of brain infection PML with Tysabri","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/137488/2016","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-confirms-recommendations-minimise-risk-brain-infection-pml-tysabri_en.pdf"},
    {"id":"41356","name":"Inclusion and exclusion criteria for the important medical events list (MedDRA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-08-19T16:58:00Z","last_updated_date":"2021-03-24T16:40:00Z","reference_number":"EMA/126913/2021","document_url":"https://www.ema.europa.eu/en/documents/other/inclusion-and-exclusion-criteria-important-medical-events-list-meddra_en.pdf"},
    {"id":"41357","name":"EU/3/14/1236: Public summary of opinion on orphan designation: Diacerein for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-03-31T03:00:00Z","last_updated_date":"2014-03-31T03:00:00Z","reference_number":"EMA/COMP/26852/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141236-public-summary-opinion-orphan-designation-diacerein-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"41358","name":"CHMP summary of positive opinion for Spedra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-04-26T14:00:00Z","last_updated_date":"2013-04-26T14:00:00Z","reference_number":"EMA/CHMP/61591/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-spedra_en.pdf"},
    {"id":"41360","name":"Launch of the new EudraVigilance system: questions and answers from stakeholders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-07-07T17:00:00Z","last_updated_date":"2018-12-04T17:30:00Z","reference_number":"EMA/132042/2018 Version 1.7","document_url":"https://www.ema.europa.eu/en/documents/other/launch-new-eudravigilance-system-questions-and-answers-stakeholders_en.pdf"},
    {"id":"41363","name":"CHMP summary of positive opinion for Tolucombi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-01-18T13:00:00Z","last_updated_date":"2013-01-18T13:00:00Z","reference_number":"EMA/CHMP/6036/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tolucombi_en.pdf"},
    {"id":"41366","name":"Presentation - Action on antimicrobial resistance – A brief overview of EPHA’s advocacy campaign - Session 4 (Sascha Marschang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-09T02:00:00Z","last_updated_date":"2017-10-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-action-antimicrobial-resistance-brief-overview-ephas-advocacy-campaign-session-4-sascha-marschang_en.pdf"},
    {"id":"41370","name":"Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting (15 March 2017)","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2017-03-02T01:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"EMA/69326/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-and-healthcare-professionals-organisations-hcpwp-joint-meeting-15-march-2017_en.pdf"},
    {"id":"41372","name":"Compilation of individual product-specific guidance on demonstration of bioequivalence","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-12-19T18:35:00Z","last_updated_date":"2014-12-19T18:35:00Z","reference_number":"EMA/CHMP/736403/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/compilation-individual-product-specific-guidance-demonstration-bioequivalence_en.pdf-0"},
    {"id":"41375","name":"Summary - Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins with interested parties","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"EMA/49653/2016","document_url":"https://www.ema.europa.eu/en/documents/other/summary-workshop-immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-interested-parties_en.pdf"},
    {"id":"41382","name":"Presentation - Integration concept OMS-PHAROS - Austrian Federal Office for Safety in Health Care (AGES) - Substance, product, organisation and referential data (SPOR) impact on veterinary stakeholders (Georg Neuwirther)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-02-27T01:00:00Z","last_updated_date":"2018-02-27T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-integration-concept-oms-pharos-austrian-federal-office-safety-health-care-ages-substance-product-organisation-and-referential-data-spor-impact-veterinary-stakeholders-georg-neuwirther_en.pdf"},
    {"id":"41384","name":"Committee for Advanced Therapies (CAT): December 2010 meeting monthly report","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/CAT/731404/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/committee-advanced-therapies-cat-december-2010-meeting-monthly-report_en.pdf"},
    {"id":"41387","name":"Presentation - Session 3: OMOP common data model: validation approach (Jon Duke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T01:00:00Z","last_updated_date":"2018-01-09T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-omop-common-data-model-validation-approach-jon-duke_en.pdf"},
    {"id":"41388","name":"Position statement of the CPMP on oral contraceptives containing desogestrel or gestodene of 27 October 1995","type":"position","status":"Adopted","consultation_date":"","first_published_date":"1995-10-27T00:09:21Z","last_updated_date":"1995-10-27T00:09:21Z","reference_number":"CPMP/PhV/696/95","document_url":"https://www.ema.europa.eu/en/documents/position/position-statement-cpmp-oral-contraceptives-containing-desogestrel-or-gestodene-27-october-1995_en.pdf"},
    {"id":"41393","name":"Work plan for the CVMP Antimicrobials Working Party 2018","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2017-12-19T13:30:00Z","last_updated_date":"2017-12-19T13:30:00Z","reference_number":"EMA/CVMP/AWP/484533/2017","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-cvmp-antimicrobials-working-party-2018_en.pdf"},
    {"id":"41395","name":"Good practice guide on risk minimisation and prevention of medication errors","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2015-11-27T11:00:00Z","last_updated_date":"2015-11-27T11:00:00Z","reference_number":"EMA/606103/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/good-practice-guide-risk-minimisation-and-prevention-medication-errors_en.pdf"},
    {"id":"41398","name":"European Medicines Agency updates on ongoing benefit-risk review of pioglitazone–containing medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2011-06-23T02:00:00Z","last_updated_date":"2011-06-23T02:00:00Z","reference_number":"EMA/CHMP/483851/2011","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-updates-ongoing-benefit-risk-review-pioglitazone-containing-medicines_en.pdf"},
    {"id":"41399","name":"Presentation - Rare liver diseases (Ulrich Baumann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-01-19T01:00:00Z","last_updated_date":"2016-01-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rare-liver-diseases-ulrich-baumann_en.pdf"},
    {"id":"41400","name":"EU/3/14/1398: Public summary of opinion on orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T01:00:00Z","last_updated_date":"2015-02-26T01:00:00Z","reference_number":"EMA/COMP/744276/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141398-public-summary-opinion-orphan-designation-genetically-modified-serotype-53-adenovirus-coding-granulocyte-macrophage-colony-stimulating-factor-treatment-malignant-mesothelioma_en.pdf"},
    {"id":"41403","name":"CVMP post-authorisation summary of negative opinion for Suvaxyn PCV","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-11-08T18:00:00Z","last_updated_date":"2020-04-15T18:00:00Z","reference_number":"EMA/CVMP/686504/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-negative-opinion-suvaxyn-pcv_en.pdf-0"},
    {"id":"41405","name":"Opinion of the HMPC on a Community herbal monograph on Lavandula angustifolia P. Mill., flos","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2012-06-13T17:00:00Z","last_updated_date":"2012-06-13T17:00:00Z","reference_number":"EMA/HMPC/216951/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-lavandula-angustifolia-p-mill-flos_en.pdf"},
    {"id":"41406","name":"Amlodipine: List of nationally authorised medicinal products: PSUSA/00000174/201603","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-12-15T18:45:00Z","last_updated_date":"2016-12-15T18:48:03Z","reference_number":"EMA/863940/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-list-nationally-authorised-medicinal-products-psusa00000174201603_en.pdf-1"},
    {"id":"41409","name":"Tobramycin VVB and associated names Article-29(4) referral - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-05-04T02:00:00Z","last_updated_date":"2016-05-04T02:00:00Z","reference_number":"EMA/139057/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/tobramycin-vvb-and-associated-names-article-294-referral-chmp-assessment-report_en.pdf"},
    {"id":"41410","name":"PRAC rules of procedure","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-03-05T13:00:00Z","last_updated_date":"2021-10-15T14:40:00Z","reference_number":"EMA/PRAC/567515/2012 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/other/prac-rules-procedure_en.pdf"},
    {"id":"41414","name":"Presentation - Cell Therapy Limited (Ajan Reginald)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-12-16T01:00:00Z","last_updated_date":"2015-12-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cell-therapy-limited-ajan-reginald_en.pdf"},
    {"id":"41415","name":"Presentation - Supporting the European Immunization Week - EMA's PCWP and HCPWP joint meeting (Camelia Enachioiu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supporting-european-immunization-week-emas-pcwp-and-hcpwp-joint-meeting-camelia-enachioiu_en.pdf"},
    {"id":"41418","name":"Gilenya : Product Information as approved by the CHMP on 17 December 2015, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/gilenya-product-information-approved-chmp-17-december-2015-pending-endorsement-european-commission_en.pdf"},
    {"id":"41422","name":"CHMP post-authorisation summary of positive opinion for Mekinist (WS/1274)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T02:00:00Z","last_updated_date":"2018-07-27T02:00:00Z","reference_number":"EMA/CHMP/297226/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mekinist-ws1274_en.pdf"},
    {"id":"41424","name":"Calcitonin: Product information as approved by the CHMP on 15 November 2012, pending endorsement by the European Commission","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-11-16T13:00:00Z","last_updated_date":"2012-11-16T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/calcitonin-product-information-approved-chmp-15-november-2012-pending-endorsement-european-commission_en.pdf"},
    {"id":"41425","name":"EU/3/14/1344: Public summary of opinion on orphan designation: Nitric oxide for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/560372/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141344-public-summary-opinion-orphan-designation-nitric-oxide-treatment-cystic-fibrosis_en.pdf"},
    {"id":"41429","name":"Kytril - Article 30 referral - Annex III","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2011-09-12T02:00:00Z","last_updated_date":"2011-09-12T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/kytril-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/kytril-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/kytril-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/kytril-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/kytril-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/kytril-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/kytril-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/kytril-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/kytril-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/kytril-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/kytril-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/kytril-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/kytril-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/kytril-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/kytril-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/kytril-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/kytril-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/kytril-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/kytril-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/kytril-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/kytril-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/kytril-article-30-referral-annex-iii_sv.pdf"}},
    {"id":"41430","name":"Scientific advice and protocol assistance","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2013-05-22T12:00:00Z","last_updated_date":"2016-11-08T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/scientific-advice-and-protocol-assistance_en.pdf"},
    {"id":"41432","name":"Presentation - Listening to the stakeholders of innovative medicinal products – Payer viewpoint (Anna Bucsics)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T01:00:00Z","last_updated_date":"2016-12-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-listening-stakeholders-innovative-medicinal-products-payer-viewpoint-anna-bucsics_en.pdf"},
    {"id":"41434","name":"Pharmacovigilance Working Party (PhVWP) - Monthly report on safety concerns, guidelines and general matters - January 2012","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-01-26T16:20:00Z","last_updated_date":"2012-01-26T16:20:00Z","reference_number":"EMA/CHMP/PhVWP/51794/2012","document_url":"https://www.ema.europa.eu/en/documents/report/pharmacovigilance-working-party-phvwp-monthly-report-safety-concerns-guidelines-and-general-matters-january-2012_en.pdf"},
    {"id":"41437","name":"Presentation - EnprEMA/PDCO interactions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-18T16:02:00Z","last_updated_date":"2018-06-18T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpremapdco-interactions_en.pdf"},
    {"id":"41442","name":"Presentation - Young people involvement in the work of the Paediatric Committee (PDCO) - EMA's PCWP and HCPWP joint meeting (Viviana Giannuzzi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-young-people-involvement-work-paediatric-committee-pdco-emas-pcwp-and-hcpwp-joint-meeting-viviana-giannuzzi_en.pdf"},
    {"id":"41443","name":"Meningococcal group a and c polysaccharide vaccine: List of nationally authorised medicinal - PSUSA/00001970/201602","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T18:52:55Z","reference_number":"EMA/719745/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/meningococcal-group-and-c-polysaccharide-vaccine-list-nationally-authorised-medicinal-psusa00001970201602_en.pdf"},
    {"id":"41444","name":"Presentation - Medication errors: FDA perspective (Carol Holquist)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-03-11T13:00:00Z","last_updated_date":"2013-03-11T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medication-errors-fda-perspective-carol-holquist_en.pdf"},
    {"id":"41445","name":"Agenda - EMA Human Scientific Committees' Working Party with Patients' and Consumers' Organisations (PCWP) meeting with all eligible organisations","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2010-11-22T01:00:00Z","last_updated_date":"2010-11-22T01:00:00Z","reference_number":"EMA/579304/2010 rev. 2","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-human-scientific-committees-working-party-patients-and-consumers-organisations-pcwp-meeting-all-eligible-organisations_en.pdf-0"},
    {"id":"41447","name":"Christine Fletcher (DoI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/christine-fletcher-doi_en.pdf"},
    {"id":"41449","name":"Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T13:00:00Z","last_updated_date":"2016-07-27T13:00:00Z","reference_number":"EMA/CVMP/CHMP/231573/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/updated-advice-use-colistin-products-animals-within-european-union-development-resistance-and-possible-impact-human-and-animal-health_en.pdf-0"},
    {"id":"41452","name":"CHMP summary of positive opinion for Natpar","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2017-02-24T11:00:00Z","last_updated_date":"2017-02-24T11:00:00Z","reference_number":"EMA/CHMP/99882/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-natpar_en.pdf"},
    {"id":"41453","name":"Flupirtine-containing medicines Article-107i procedure - Rationale for triggering","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2013-03-08T13:00:00Z","last_updated_date":"2013-03-08T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-containing-medicines-article-107i-procedure-rationale-triggering_en.pdf"},
    {"id":"41454","name":"EMA response to Nordic Cochrane letter on human papillomavirus (HPV) vaccines - Conflict of interest issues of Executive Director","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T13:30:00Z","last_updated_date":"2016-07-22T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-response-nordic-cochrane-letter-human-papillomavirus-hpv-vaccines-conflict-interest-issues-executive-director_en.pdf"},
    {"id":"41457","name":"Agenda - Extraordinary Management Board meeting for the building approval process of European Medicines Agency premises in Amsterdam: 6 February 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-02-06T12:30:00Z","last_updated_date":"2018-02-06T12:30:00Z","reference_number":"EMA/MB/59964/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-extraordinary-management-board-meeting-building-approval-process-european-medicines-agency-premises-amsterdam-6-february-2018_en.pdf"},
    {"id":"41458","name":"EU/3/12/960: Public summary of opinion on orphan designation: Glucagon for the treatment of congenital hyperinsulinism","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2012-04-19T11:45:00Z","last_updated_date":"2012-04-19T11:45:00Z","reference_number":"EMA/COMP/61086/2012","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu312960-public-summary-opinion-orphan-designation-glucagon-treatment-congenital-hyperinsulinism_en.pdf"},
    {"id":"41459","name":"Annex III - Service concession: Declaration of honour on exclusion criteria and selection criteria  (EMA/2016/43/RS)","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2016-08-15T12:30:00Z","last_updated_date":"2016-08-15T12:30:00Z","reference_number":"EMA/2016/43/RS","document_url":"https://www.ema.europa.eu/en/documents/procurement/annex-iii-service-concession-declaration-honour-exclusion-criteria-and-selection-criteria-ema201643rs_en.pdf"},
    {"id":"41465","name":"PDCO meeting highlights 17-19 February 2010","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2010-02-24T00:09:21Z","last_updated_date":"2010-02-24T01:00:00Z","reference_number":"EMA/PDCO/97062/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-meeting-highlights-17-19-february-2010_en.pdf"},
    {"id":"41466","name":"EMLA cream Article-30 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-15T01:00:00Z","last_updated_date":"2015-01-15T01:00:00Z","reference_number":"EMA/707790/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/emla-cream-article-30-referral-assessment-report_en.pdf"},
    {"id":"41467","name":"Diphtheria / tetanus / poliomyelitis (inactivated) vaccine (adsorbed, reduced antigens(s) content): List of nationally authorised medicinal products - PSUSA/00001127/201708","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T12:41:00Z","last_updated_date":"2018-04-17T12:44:45Z","reference_number":"EMA/229018/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheria-tetanus-poliomyelitis-inactivated-vaccine-adsorbed-reduced-antigenss-content-list-nationally-authorised-medicinal-products-psusa00001127201708_en.pdf"},
    {"id":"41468","name":"CHMP post-authorisation summary of positive opinion for Zydelig","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/CHMP/500725/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zydelig_en.pdf-0"},
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    {"id":"41471","name":"CHMP statistics: January 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-26T01:00:00Z","last_updated_date":"2018-01-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-january-2018_en.pdf"},
    {"id":"41472","name":"Annex III: Draft donation agreement","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-29T12:45:00Z","last_updated_date":"2016-07-29T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-iii-draft-donation-agreement_en.pdf"},
    {"id":"41474","name":"Opinion following an Article-13 referral for Resflor solution injectable and associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-09T18:30:00Z","last_updated_date":"2015-01-09T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-13-referral-resflor-solution-injectable-and-associated-names_sv.pdf"}},
    {"id":"41476","name":"CHMP summary of positive opinion for Lartruvo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-09-16T02:00:00Z","last_updated_date":"2019-09-02T11:00:00Z","reference_number":"EMA/CHMP/589981/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lartruvo_en.pdf"},
    {"id":"41478","name":"CHMP summary of positive opinion for Ebilfumin","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2014-03-21T13:00:00Z","last_updated_date":"2014-03-21T13:00:00Z","reference_number":"EMA/CHMP/66668/2014 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ebilfumin_en.pdf"},
    {"id":"41479","name":"Draft assessment report on Allium sativum L., bulbus","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2016-07-25T02:00:00Z","last_updated_date":"2016-07-25T02:00:00Z","reference_number":"EMA/HMPC/7686/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-allium-sativum-l-bulbus_en.pdf"},
    {"id":"41480","name":"Declaration of interests: Federica Castellani","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-01T02:00:00Z","last_updated_date":"2018-05-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-federica-castellani_en.pdf"},
    {"id":"41482","name":"Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 20-23 January 2014","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2014-01-30T11:30:00Z","last_updated_date":"2014-01-30T11:30:00Z","reference_number":"EMA/11105/2014","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-annual-re-assessments-renewals-marketing-authorisations-and-accelerated-assessment-procedures-adopted-chmp-meeting-20-23-january-2014_en.pdf"},
    {"id":"41483","name":"Fluticasone propionate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation-  PSUSA/00001454/201702","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T18:04:00Z","last_updated_date":"2018-01-03T18:10:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001454201702_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/fluticasone-propionate-cmdh-scientific-conclusions-and-grounds-varia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    {"id":"41501","name":"EudraVigilance reporting process for users: Introduction to EVWEB - Training Module EV-M3b","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-06T15:00:00Z","last_updated_date":"2018-07-26T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eudravigilance-reporting-process-users-introduction-evweb-training-module-ev-m3b_en.pdf"},
    {"id":"41503","name":"Rabbit anti-human thymocyte (powder for solution for\n\ninfusion): List of nationally authorised medicinal products - PSUSA/00010184/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-23T11:00:00Z","last_updated_date":"2016-10-17T19:31:36Z","reference_number":"EMA/148859/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/rabbit-anti-human-thymocyte-powder-solution-infusion-list-nationally-authorised-medicinal-products-psusa00010184201506_en.pdf"},
    {"id":"41505","name":"EU/3/18/2019: Public summary of opinion on orphan designation: Bardoxolone methyl for the treatment of Alport syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-07-23T17:07:00Z","last_updated_date":"2018-07-23T17:07:00Z","reference_number":"EMA/266267/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182019-public-summary-opinion-orphan-designation-bardoxolone-methyl-treatment-alport-syndrome_en.pdf"},
    {"id":"41506","name":"CHMP post-authorisation summary of positive opinion for Valdoxan","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-09-20T02:00:00Z","last_updated_date":"2013-09-20T02:00:00Z","reference_number":"EMA/CHMP/577714/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-valdoxan_en.pdf"},
    {"id":"41507","name":"Summary of transfers of appropriations in the budget 2010 - Management Board meeting: 10 June 2010","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-18T02:00:00Z","last_updated_date":"2010-06-18T02:00:00Z","reference_number":"EMA/MB/298753/2010","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfers-appropriations-budget-2010-management-board-meeting-10-june-2010_en.pdf"},
    {"id":"41513","name":"Ergot derivatives Article-31 referral - Restrictions on use of medicines containing ergot derivatives","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"EMA/27446/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ergot-derivatives-article-31-referral-restrictions-use-medicines-containing-ergot-derivatives_sv.pdf"}},
    {"id":"41516","name":"Amoxil Article-30 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-09-14T02:00:00Z","last_updated_date":"2015-09-14T02:00:00Z","reference_number":"EMA/499802/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/amoxil-article-30-referral-assessment-report_en.pdf"},
    {"id":"41518","name":"CHMP summary of positive opinion for Leflunomide Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2014-03-18T01:00:00Z","reference_number":"EMA/CHMP/605159/2010","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-leflunomide-teva_en.pdf"},
    {"id":"41519","name":"Dienogest / Ethinylestradiol Article-31 referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2017-03-24T01:00:00Z","last_updated_date":"2017-03-24T01:00:00Z","reference_number":"EMA/174401/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/dienogest-ethinylestradiol-article-31-referral-assessment-report_en.pdf"},
    {"id":"41520","name":"Presentation - EU IDMP/SPOR Task Force meeting: SPOR communications and change Management (8. agenda) (Agnieszka Laka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-idmpspor-task-force-meeting-spor-communications-and-change-management-8-agenda-agnieszka-laka_en.pdf"},
    {"id":"41522","name":"Presentation - Breakout session - Neonatal lung injury (Robin Steinhorn and Mary Short)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-11T02:00:00Z","last_updated_date":"2015-06-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-neonatal-lung-injury-robin-steinhorn-and-mary-short_en.pdf"},
    {"id":"41525","name":"Opinion following an Article 33(4) referral for Equimectin 12mg/g oral gel for horses: Background information","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2008-06-02T01:59:00Z","last_updated_date":"2008-06-02T01:59:00Z","reference_number":"EMEA/532271/2007 – Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_hu.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/opinion-following-article-334-referral-equimectin-12mgg-oral-gel-horses-background-information_sv.pdf"}},
    {"id":"41526","name":"List of participants - 10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-10th-anniversary-european-medicines-agencys-patients-and-consumers-working-party-pcwp_en.pdf"},
    {"id":"41530","name":"Presentation - Finnish Investigators Network for Pediatric Medicines (FINPEDMED) - IT development for e-Services 2006-2015 (Pirkko Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-25T02:00:00Z","last_updated_date":"2015-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-finnish-investigators-network-pediatric-medicines-finpedmed-it-development-e-services-2006-2015-pirkko-lepola_en.pdf"},
    {"id":"41532","name":"EU/3/14/1395: Public summary of opinion on orphan designation: Allogeneic ex vivo-generated natural killer cells from CD34+ umbilical cord blood progenitor cells for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-02-26T01:00:00Z","last_updated_date":"2015-02-26T01:00:00Z","reference_number":"EMA/COMP/730059/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141395-public-summary-opinion-orphan-designation-allogeneic-ex-vivo-generated-natural-killer-cells-cd34-umbilical-cord-blood-progenitor-cells-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"41534","name":"Presentation - SCOPE Joint action work package 6 on risk communication (Dolores Montero)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-05T02:00:00Z","last_updated_date":"2016-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scope-joint-action-work-package-6-risk-communication-dolores-montero_en.pdf"},
    {"id":"41535","name":"Bacterial lysate medicines Article 31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-29T02:00:00Z","last_updated_date":"2019-03-06T16:27:00Z","reference_number":"EMA/CHMP/349538/2018 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/bacterial-lysate-medicines-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"41538","name":"Presentation - Establishing, Assessing, and Comparing Quality Attributes from a Small Sample of Development Batches through Full-scale Production (K. Vukovinsky, Pfizer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-07-05T02:00:00Z","last_updated_date":"2018-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-establishing-assessing-and-comparing-quality-attributes-small-sample-development-batches-through-full-scale-production-k-vukovinsky-pfizer_en.pdf"},
    {"id":"41540","name":"CHMP post-authorisation summary of positive opinion for Pradaxa","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-11-22T01:00:00Z","last_updated_date":"2013-11-22T01:00:00Z","reference_number":"EMA/CHMP/719108/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pradaxa_en.pdf-5"},
    {"id":"41541","name":"Questions and answers on the withdrawal of the marketing application for  Cerepro","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2007-07-19T02:00:00Z","last_updated_date":"2007-07-19T02:00:00Z","reference_number":"EMEA/318692/2007","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-application-cerepro_sv.pdf"}},
    {"id":"41543","name":"Public statement on Salvia fruticosa Mill., folium","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2016-07-01T02:00:00Z","last_updated_date":"2016-07-01T02:00:00Z","reference_number":"EMA/HMPC/599993/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-salvia-fruticosa-mill-folium_en.pdf"},
    {"id":"41548","name":"High level business consultancy EMA/2013/23/FI - Technical specifications - Annex VIII award criteria questionnaire","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-11T02:00:00Z","last_updated_date":"2013-09-11T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/high-level-business-consultancy-ema201323fi-technical-specifications-annex-viii-award-criteria-questionnaire_en.doc"},
    {"id":"41551","name":"5 Fluorouracil (i.v. application): List of nationally authorised medicinal products - PSUSA/00000007/201412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2016-10-17T16:39:22Z","reference_number":"EMA/706456/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/5-fluorouracil-iv-application-list-nationally-authorised-medicinal-products-psusa00000007201412_en.pdf"},
    {"id":"41553","name":"Withdrawal letter for Naxcel: Extension (new target species)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-06-23T02:00:00Z","last_updated_date":"2010-06-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-naxcel-extension-new-target-species_en.pdf"},
    {"id":"41558","name":"Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-12T19:17:00Z","last_updated_date":"2018-09-12T19:20:06Z","reference_number":"EMA/617522/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/lubiprostone-list-nationally-authorised-medicinal-products-psusa00010290201801_en.pdf"},
    {"id":"41559","name":"Presentation - Introduction to posters (Peter Richardson, David Tainsh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-11-17T01:00:00Z","last_updated_date":"2015-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-posters-peter-richardson-david-tainsh_en.pdf"},
    {"id":"41565","name":"Overview of comments received on community herbal monograph on Hamamelis virginiana L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"EMA/HMPC/280729/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-hamamelis-virginiana-l-folium_en.pdf"},
    {"id":"41566","name":"Flupirtine Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-05-04T02:00:00Z","last_updated_date":"2018-05-04T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/flupirtine-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/flupirtine-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/flupirtine-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/flupirtine-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/flupirtine-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/flupirtine-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/flupirtine-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/flupirtine-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/flupirtine-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/flupirtine-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/flupirtine-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/flupirtine-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/flupirtine-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/flupirtine-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/flupirtine-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/flupirtine-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/flupirtine-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/flupirtine-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/flupirtine-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/flupirtine-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/flupirtine-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/flupirtine-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/flupirtine-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"41570","name":"Presentation - 5.2 Goal attainment scaling: individualized instrument with potential for outcome measurement in rare diseases (Hanneke van der Lee, Charlotte Gaasterland, Susanne Urach)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-52-goal-attainment-scaling-individualized-instrument-potential-outcome-measurement-rare-diseases-hanneke-van-der-lee-charlotte-gaasterland-susanne-urach_en.pdf"},
    {"id":"41571","name":"Guidelines and concept papers adopted during the CHMP meeting 29 March - 1 April 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-04-08T12:20:00Z","last_updated_date":"2016-04-08T12:20:00Z","reference_number":"EMA/76588/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/guidelines-and-concept-papers-adopted-during-chmp-meeting-29-march-1-april-2016_en.pdf"},
    {"id":"41575","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: January 2017","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2017-02-20T11:50:00Z","last_updated_date":"2017-02-20T11:50:00Z","reference_number":"EMA/43619/2017","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-january-2017_en.pdf"},
    {"id":"41578","name":"Glibenclamide / metformin hydrochloride: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002002/201506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-21T02:00:00Z","last_updated_date":"2016-10-17T15:56:42Z","reference_number":"EMA/284334/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/glibenclamide-metformin-hydrochloride-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00002002201506_en.pdf"},
    {"id":"41579","name":"Cefadroxil: List of nationally authorised medicinal products - PSUSA/00000584/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-04-26T15:53:00Z","last_updated_date":"2018-04-26T16:01:39Z","reference_number":"EMA/261995/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefadroxil-list-nationally-authorised-medicinal-products-psusa00000584201707_en.pdf"},
    {"id":"41582","name":"CHMP post-authorisation summary of positive opinion for Ruconest","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-02-26T01:00:00Z","reference_number":"EMA/CHMP/137174/2016","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ruconest_en.pdf-0"},
    {"id":"41584","name":"Rupatadine: List of nationally authorised medicinal products -   PSUSA/00002673/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-18T14:16:00Z","last_updated_date":"2018-07-18T14:18:34Z","reference_number":"EMA/486464/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/rupatadine-list-nationally-authorised-medicinal-products-psusa00002673201712_en.pdf"},
    {"id":"41585","name":"List of participants: Towards EU accession: Serbia’s regulatory challenges expectations and opportunities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/781955/2010","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-towards-eu-accession-serbias-regulatory-challenges-expectations-and-opportunities_en.pdf"},
    {"id":"41586","name":"Agenda - 2015 Pharmacovigilance Inspectors Working Group training course (human session)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2015-11-05T01:00:00Z","last_updated_date":"2015-11-05T01:00:00Z","reference_number":"EMA/INS/PhV/724709/2015 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2015-pharmacovigilance-inspectors-working-group-training-course-human-session_en.pdf"},
    {"id":"41587","name":"Public summary of the evaluation of a proposed product-specific\n\nwaiver: Calcium (carbonate) / cholecalciferol (in combination with zoledronic acid (monohydrate)) for prevention of skeletal related events in patients wit...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T12:30:00Z","last_updated_date":"2015-02-23T12:30:00Z","reference_number":"EMA/69421/2015","document_url":"https://www.ema.europa.eu/en/documents/other/public-summary-evaluation-proposed-product-specific-waiver-calcium-carbonate-cholecalciferol-combination-zoledronic-acid-monohydrate-prevention-skeletal-related-events-patients-wit_en.pdf"},
    {"id":"41588","name":"Presentation - ISO ICSR standard implementation for IT system developers - Training module IT-M1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-06T15:00:00Z","last_updated_date":"2017-01-06T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-iso-icsr-standard-implementation-it-system-developers-training-module-it-m1_en.pdf"},
    {"id":"41591","name":"Work instructions for checking of MRL status of constituents of veterinary medicinal products subject to a marketing authorisation application to the EMA","type":"win","status":"Adopted","consultation_date":"","first_published_date":"2015-05-28T13:10:00Z","last_updated_date":"2015-05-28T13:10:00Z","reference_number":"WIN/V/4046","document_url":"https://www.ema.europa.eu/en/documents/win/work-instructions-checking-mrl-status-constituents-veterinary-medicinal-products-subject-marketing-authorisation-application-ema_en.pdf"},
    {"id":"41592","name":"Start of community reviews - CHMP meeting of 23-26 June 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/388940/2014","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-23-26-june-2014_en.pdf"},
    {"id":"41595","name":"Overview of comments received on 'Guideline on the environmental risk assessment of medicinal products for human use’ - Revision 1","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-06-02T11:20:00Z","last_updated_date":"2016-06-02T11:20:00Z","reference_number":"EMA/CHMP/SWP/96156/2016","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-environmental-risk-assessment-medicinal-products-human-use-revision-1_en.pdf"},
    {"id":"41598","name":"Draft policy/0043: European Medicines Agency policy on access to documents","type":"other","status":"Draft: consultation closed","consultation_date":"","first_published_date":"2017-02-17T14:30:00Z","last_updated_date":"2017-02-17T14:30:00Z","reference_number":"EMA/729522/2016","document_url":"https://www.ema.europa.eu/en/documents/other/draft-policy0043-european-medicines-agency-policy-access-documents_en.pdf"},
    {"id":"41599","name":"Draft assessment report on Valeriana officinalis L., radix and Valeriana officinalis L., aetheroleum","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2015-07-23T02:00:00Z","last_updated_date":"2015-07-23T02:00:00Z","reference_number":"EMA/HMPC/150846/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-valeriana-officinalis-l-radix-and-valeriana-officinalis-l-aetheroleum_en.pdf"},
    {"id":"41601","name":"Committee for medicinal products for human use, summary of positive opinion for Irbesartan/Hydrochlorothiazide Teva","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2009-09-25T02:00:00Z","last_updated_date":"2009-09-25T02:00:00Z","reference_number":"EMEA/592212/2009","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-irbesartanhydrochlorothiazide-teva_en.pdf"},
    {"id":"41602","name":"Presentation - AIFA and the ISO IDMP implementation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-06-18T02:00:00Z","last_updated_date":"2015-06-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-aifa-and-iso-idmp-implementation_en.pdf"},
    {"id":"41604","name":"Agenda - Paediatric rheumatology expert group meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2010-05-28T02:00:00Z","last_updated_date":"2010-05-28T02:00:00Z","reference_number":"EMA/809438/2009","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-paediatric-rheumatology-expert-group-meeting_en.pdf-0"},
    {"id":"41607","name":"EU/3/17/1880: Public summary of opinion on orphan designation: Avacopan for the treatment of C3 glomerulopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-17T02:00:00Z","last_updated_date":"2017-07-17T02:00:00Z","reference_number":"EMA/323352/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171880-public-summary-opinion-orphan-designation-avacopan-treatment-c3-glomerulopathy_en.pdf"},
    {"id":"41609","name":"Questions and answers on recommendation for the refusal of a change to the marketing authorisation for Lyrica","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2009-07-24T02:00:00Z","last_updated_date":"2009-07-24T02:00:00Z","reference_number":"EMEA/464033/2009","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_fr.pdf","it":"https://www.ema.europa.eu/it/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop/questions-and-answers-recommendation-refusal-change-marketing-authorisation-lyrica_sv.pdf"}},
    {"id":"41610","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: April 2016 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2016-05-13T16:05:00Z","last_updated_date":"2016-05-13T16:05:00Z","reference_number":"EMA/CAT/318967/2016","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-april-2016-meeting_en.pdf"},
    {"id":"41611","name":"CHMP post-authorisation summary of positive opinion for Yervoy (II-44)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2017-12-15T13:00:00Z","last_updated_date":"2017-12-15T13:00:00Z","reference_number":"EMA/CHMP/807424/2017 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yervoy-ii-44_en.pdf"},
    {"id":"41612","name":"Start of Community reviews - CHMP meeting of 22-25 September 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-09-26T14:00:00Z","last_updated_date":"2014-09-26T14:00:00Z","reference_number":"EMA/388940/2014","document_url":"https://www.ema.europa.eu/en/documents/other/start-community-reviews-chmp-meeting-22-25-september-2014_en.pdf"},
    {"id":"41614","name":"Presentation - EU IDMP/SPOR Task Force meeting: Outcome of the ISO Plenary meeting held in Amsterdam on 2-6 May 2016 (3. agenda) (Paolo Alcini)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-idmpspor-task-force-meeting-outcome-iso-plenary-meeting-held-amsterdam-2-6-may-2016-3-agenda-paolo-alcini_en.pdf"},
    {"id":"41615","name":"Core summary of product characteristics for Radiopharmaceuticals","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/CHMP/EWP/430004/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/core-summary-product-characteristics-radiopharmaceuticals_en.pdf"},
    {"id":"41619","name":"Presentation - Approaches for quality control testing\n\nof LSD vaccines (Annebel De Vleeschauwer and Kris De Clercq)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-23T16:39:00Z","last_updated_date":"2017-05-23T16:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-approaches-quality-control-testing-lsd-vaccines-annebel-de-vleeschauwer-and-kris-de-clercq_en.pdf"},
    {"id":"41620","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2014 meeting","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2015-01-06T17:11:00Z","last_updated_date":"2015-01-06T17:11:00Z","reference_number":"EMA/CAT/789277/2014","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-december-2014-meeting_en.pdf"},
    {"id":"41621","name":"Cefuroxime axetil : List of nationally authorised medicinal products - PSUSA/00009099/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T12:46:00Z","last_updated_date":"2017-12-01T12:47:55Z","reference_number":"EMA/787932/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefuroxime-axetil-list-nationally-authorised-medicinal-products-psusa00009099201704_en.pdf"},
    {"id":"41622","name":"Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2015-12-07T01:00:00Z","last_updated_date":"2016-10-17T16:44:24Z","reference_number":"EMA/826295/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetylsalicylic-acid-bisoprolol-list-nationally-authorised-medicinal-products-psusa00010287201505_en.pdf"},
    {"id":"41627","name":"Final assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum - First version","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T13:00:00Z","last_updated_date":"2015-04-09T13:00:00Z","reference_number":"EMA/HMPC/320932/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-andor-other-species-melaleuca-aetheroleum-first-version_en.pdf"},
    {"id":"41629","name":"CVMP post-authorisation summary of positive opinion for Vectormune ND (II/0007)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-01-19T01:00:00Z","last_updated_date":"2018-01-19T01:00:00Z","reference_number":"EMA/CVMP/739766/2017","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-vectormune-nd-ii0007_en.pdf"},
    {"id":"41631","name":"Report on the survey of all paediatric uses of medicinal\n\nproducts in Europe: Executive summary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2011-01-21T00:31:00Z","last_updated_date":"2011-01-21T00:31:00Z","reference_number":"EMA/761434/2010","document_url":"https://www.ema.europa.eu/en/documents/other/report-survey-all-paediatric-uses-medicinal-products-europe-executive-summary_en.pdf"},
    {"id":"41632","name":"News bulletin for small and medium-sized enterprises - Issue 28","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2014-06-30T16:23:00Z","last_updated_date":"2014-06-30T16:23:00Z","reference_number":"Issue 28","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-28_en.pdf"},
    {"id":"41634","name":"Dienogest / Ethinylestradiol Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2016-02-26T01:00:00Z","last_updated_date":"2016-12-16T13:00:00Z","reference_number":"EMA/CHMP/147246/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/dienogest-ethinylestradiol-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"41637","name":"Presentation - 6.4 Improved methodology for use of non-linear mixed effect models (NLMEM) in decision making (Mats O. Karlsson, Andrew Hooker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-04-20T02:00:00Z","last_updated_date":"2017-04-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-64-improved-methodology-use-non-linear-mixed-effect-models-nlmem-decision-making-mats-o-karlsson-andrew-hooker_en.pdf"},
    {"id":"41638","name":"Public Statement on the use of herbal medicinal products containing asarone","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-23T01:00:00Z","last_updated_date":"2005-11-23T01:00:00Z","reference_number":"EMEA/HMPC/139215/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-statement-use-herbal-medicinal-products-containing-asarone_en.pdf"},
    {"id":"41639","name":"EU/3/15/1447: Public summary of opinion on orphan designation: Olaratumab for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-04-09T02:00:00Z","last_updated_date":"2020-01-15T02:00:00Z","reference_number":"EMA/COMP/25527/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151447-public-summary-opinion-orphan-designation-olaratumab-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"41640","name":"Domperidone: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - 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    {"id":"41643","name":"New advice to minimise risk of next-morning impaired driving ability and mental alertness with zolpidem","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2014-08-04T12:00:00Z","last_updated_date":"2014-08-04T12:00:00Z","reference_number":"EMA/427574/2014","document_url":"https://www.ema.europa.eu/en/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/new-advice-minimise-risk-next-morning-impaired-driving-ability-and-mental-alertness-zolpidem_sv.pdf"}},
    {"id":"41648","name":"Presentation - EV Reporting process for users: EV Gateway, WEB-Trader, EV-Post functions - Training Module EV-M3a","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-06T15:00:00Z","last_updated_date":"2017-01-06T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ev-reporting-process-users-ev-gateway-web-trader-ev-post-functions-training-module-ev-m3a_en.pdf"},
    {"id":"41652","name":"EU/3/17/1959: Public summary of opinion on orphan designation: Cannabidiol for the treatment of tuberous sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/5287/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171959-public-summary-opinion-orphan-designation-cannabidiol-treatment-tuberous-sclerosis_en.pdf"},
    {"id":"41658","name":"EU/3/15/1605: Public summary of opinion on orphan designation: Synthetic double-stranded oligomer specific to the SERPINA1 gene and containing a cholesterol-conjugated, acyclic nucleobase analogue for the treatment of co...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-02-05T01:00:00Z","last_updated_date":"2017-05-17T02:00:00Z","reference_number":"EMA/COMP/852267/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151605-public-summary-opinion-orphan-designation-synthetic-double-stranded-oligomer-specific-serpina1-gene-and-containing-cholesterol-conjugated-acyclic-nucleobase-analogue-treatment-co_en.pdf"},
    {"id":"41659","name":"Presentation - Incentives and regulatory considerations in orphan drug/medical device development - Situation in Japan (Hiroshi Takeda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-03-28T14:00:00Z","last_updated_date":"2014-03-28T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-incentives-and-regulatory-considerations-orphan-drugmedical-device-development-situation-japan-hiroshi-takeda_en.pdf"},
    {"id":"41660","name":"European paediatric research network ready to start","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-05-12T02:00:00Z","last_updated_date":"2010-05-12T02:00:00Z","reference_number":"EMA/273427/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-paediatric-research-network-ready-start_en.pdf"},
    {"id":"41663","name":"EU/3/14/1319: Public summary of opinion on orphan designation: Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-01T02:00:00Z","last_updated_date":"2014-10-01T02:00:00Z","reference_number":"EMA/COMP/434793/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141319-public-summary-opinion-orphan-designation-recombinant-factor-viia-modified-three-terminal-repeats-derived-i2-chain-human-chorionic-gonadotropin-treatment-haemophilia-b_en.pdf"},
    {"id":"41666","name":"Presentation - EMA support to and involvement in regulatory science (Corinne de Vries)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-30T02:00:00Z","last_updated_date":"2016-06-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-support-and-involvement-regulatory-science-corinne-de-vries_en.pdf"},
    {"id":"41668","name":"Annex C - Response questionnaire - Lot 6","type":"other","status":"unknown","consultation_date":"","first_published_date":"2008-11-25T01:00:00Z","last_updated_date":"2008-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-c-response-questionnaire-lot-6_en.xls"},
    {"id":"41672","name":"European Medicines Agency confirms positive benefit-risk balance of RotaTeq","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2010-09-23T02:00:00Z","last_updated_date":"2010-09-23T02:00:00Z","reference_number":"EMA/CHMP/588332/2010","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-confirms-positive-benefit-risk-balance-rotateq_en.pdf"},
    {"id":"41673","name":"Agenda - EudraVigilance training on electronic reporting of ICSRs in the European Economic Area, Paris","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2017-09-25T18:00:00Z","last_updated_date":"2017-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eudravigilance-training-electronic-reporting-icsrs-european-economic-area-paris_en.pdf"},
    {"id":"41676","name":"Final assessment report on Primula veris L., and Primula elatior (L.) Hill, flos’ - Superseded","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2010-04-09T02:00:00Z","last_updated_date":"2010-04-09T02:00:00Z","reference_number":"EMA/HMPC/405544/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-primula-veris-l-and-primula-elatior-l-hill-flos-superseded_en.pdf"},
    {"id":"41677","name":"Retinoid Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T01:00:00Z","last_updated_date":"2018-03-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-annex-iii_en.pdf-0"},
    {"id":"41680","name":"Atacand Plus - Article 30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-06-25T02:00:00Z","last_updated_date":"2011-09-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/atacand-plus-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/atacand-plus-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/atacand-plus-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/atacand-plus-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/atacand-plus-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/atacand-plus-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/atacand-plus-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/atacand-plus-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/atacand-plus-article-30-referral-annex-iii_fr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/atacand-plus-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/atacand-plus-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/atacand-plus-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/atacand-plus-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/atacand-plus-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/atacand-plus-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/atacand-plus-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/atacand-plus-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/atacand-plus-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/atacand-plus-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/atacand-plus-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/atacand-plus-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/atacand-plus-article-30-referral-annex-iii_sv.pdf"}},
    {"id":"41681","name":"Opinion of the HMPC on a European Union herbal monograph on Olea europaea L., folium - First version","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2018-01-04T01:00:00Z","last_updated_date":"2018-01-04T01:00:00Z","reference_number":"EMA/HMPC/65917/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-olea-europaea-l-folium-first-version_en.pdf"},
    {"id":"41682","name":"Presentation - Signal  management: industry viewpoint","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-18T02:00:00Z","last_updated_date":"2016-04-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-signal-management-industry-viewpoint_en.pdf"},
    {"id":"41684","name":"Presentation - User safety and environmental safety","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-user-safety-and-environmental-safety_en.pdf"},
    {"id":"41686","name":"Thiamphenicol: List of nationally authorised medicinal products-PSUSA/00002925/201505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2006-01-22T11:35:00Z","last_updated_date":"2016-10-19T12:44:50Z","reference_number":"EMA/50405/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/thiamphenicol-list-nationally-authorised-medicinal-products-psusa00002925201505_en.pdf"},
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    {"id":"41690","name":"Summary of transfer of appropriations in the budget 2015 and 2016 - Management Board meeting: 17 March 2016","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-03-21T17:00:00Z","last_updated_date":"2016-03-21T17:00:00Z","reference_number":"EMA/MB/89899/2016","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2015-and-2016-management-board-meeting-17-march-2016_en.pdf"},
    {"id":"41691","name":"Presentation - Shifting the MTD paradigm in oncology (Kevin Smart, Georgina Meneses-Lorente)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-07T13:00:00Z","last_updated_date":"2015-01-07T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-shifting-mtd-paradigm-oncology-kevin-smart-georgina-meneses-lorente_en.pdf"},
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    {"id":"41694","name":"Individual case safety reports (ICSR) export managerliterature test cases XML format","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-06-30T14:00:00Z","last_updated_date":"2015-06-30T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/individual-case-safety-reports-icsr-export-managerliterature-test-cases-xml-format_en.zip"},
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    {"id":"41696","name":"Collaboration and exchange of information between the COMP and the Paediatric Committee","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-05-20T02:00:00Z","last_updated_date":"2010-05-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/collaboration-and-exchange-information-between-comp-and-paediatric-committee_en.pdf"},
    {"id":"41697","name":"Final assessment report on Artemisia absinthium L., herba - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2017-10-05T02:00:00Z","last_updated_date":"2017-10-05T02:00:00Z","reference_number":"EMA/HMPC/751484/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-artemisia-absinthium-l-herba-revision-1_en.pdf"},
    {"id":"41698","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 June 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-06-24T14:00:00Z","last_updated_date":"2016-06-24T14:00:00Z","reference_number":"EMA/CHMP/SAWP/436366/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-20-23-june-2016_en.pdf"},
    {"id":"41701","name":"Inhaled corticosteroids Article-31 referral - PRAC list of questions","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2015-05-08T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/PRAC/290016/2015","document_url":"https://www.ema.europa.eu/en/documents/referral/inhaled-corticosteroids-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"41702","name":"EU/3/14/1337: Public summary of opinion on orphan designation: Acamprosate calcium for the treatment of fragile X syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-11-12T13:00:00Z","last_updated_date":"2014-11-12T13:00:00Z","reference_number":"EMA/COMP/556117/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141337-public-summary-opinion-orphan-designation-acamprosate-calcium-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"41703","name":"Questions and answers on withdrawal of marketing authorisation application for Sliwens (eplivanserin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2010-01-20T01:00:00Z","last_updated_date":"2010-01-20T01:00:00Z","reference_number":"EMA/23705/2010","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_fr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-sliwens-eplivanserin_sv.pdf"}},
    {"id":"41705","name":"Agenda and registration form - Information Day on Medication Errors","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-02-18T01:00:00Z","last_updated_date":"2016-10-18T12:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-information-day-medication-errors_en.pdf"},
    {"id":"41708","name":"Presentation: Antimicrobial Advice ad hoc Expert Group (AMEG) - The impact on public and animal health of the use of antibiotics in animals - Discussion on question three (Catry Boudewijn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antimicrobial-advice-ad-hoc-expert-group-ameg-impact-public-and-animal-health-use-antibiotics-animals-discussion-question-three-catry-boudewijn_en.pdf"},
    {"id":"41709","name":"Presentation - PNH indication update based on data from  Global  Registry(Martine Zimmermann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-12-07T11:36:00Z","last_updated_date":"2016-12-07T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pnh-indication-update-based-data-global-registrymartine-zimmermann_en.pdf"},
    {"id":"41715","name":"Vinorelbine : List of nationally authorised medicinal products - PSUSA/00003124/201704","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2017-12-01T14:50:00Z","last_updated_date":"2017-12-01T14:54:47Z","reference_number":"EMA/795271/2017","document_url":"https://www.ema.europa.eu/en/documents/psusa/vinorelbine-list-nationally-authorised-medicinal-products-psusa00003124201704_en.pdf"},
    {"id":"41718","name":"EU/3/14/1285: Public summary of opinion on orphan designation: Afamelanotide for the treatment of familial benign chronic pemphigus (Hailey-Hailey disease)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/COMP/317253/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141285-public-summary-opinion-orphan-designation-afamelanotide-treatment-familial-benign-chronic-pemphigus-hailey-hailey-disease_en.pdf"},
    {"id":"41719","name":"Annual report of the Pharmacovigilance Inspectors Working Group for 2016","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2017-08-08T16:20:00Z","last_updated_date":"2017-08-08T16:20:00Z","reference_number":"EMA/INS/PhV/614022/2016","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-pharmacovigilance-inspectors-working-group-2016_en.pdf"},
    {"id":"41721","name":"Committee for medicinal products for human use  summary of positive opinion  for Zarzio","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2008-11-20T01:00:00Z","last_updated_date":"2008-11-20T01:00:00Z","reference_number":"EMEA/CHMP/574426/2008","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/committee-medicinal-products-human-use-summary-positive-opinion-zarzio_en.pdf"},
    {"id":"41724","name":"Codeine not to be used in children below 12 years for cough and cold","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2015-04-24T02:00:00Z","last_updated_date":"2015-04-24T02:00:00Z","reference_number":"EMA/249413/2015","document_url":"https://www.ema.europa.eu/en/documents/press-release/codeine-not-be-used-children-below-12-years-cough-and-cold_en.pdf"},
    {"id":"41728","name":"EU/3/16/1649: Public summary of opinion on orphan designation: Humanised recombinant IgG4 anti-human tau antibody for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-30T02:00:00Z","last_updated_date":"2020-04-01T02:00:00Z","reference_number":"EMA/COMP/241978/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161649-public-summary-opinion-orphan-designation-humanised-recombinant-igg4-anti-human-tau-antibody-treatment-progressive-supranuclear-palsy_en.pdf"},
    {"id":"41729","name":"Presentation - Eradication of carriage (Jan Kluytmans)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-09-25T18:00:00Z","last_updated_date":"2013-09-25T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eradication-carriage-jan-kluytmans_en.pdf"},
    {"id":"41731","name":"Overview of comments received on 'draft voriconazole product-specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-07-07T14:15:00Z","last_updated_date":"2015-07-07T14:15:00Z","reference_number":"EMA/CHMP/116571/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-voriconazole-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"41734","name":"Presentation - Update on preparation for Signal Management (Georgy Genov)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-04-29T02:00:00Z","last_updated_date":"2016-04-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-preparation-signal-management-georgy-genov_en.pdf"},
    {"id":"41735","name":"European Medicines Agency gives recommendations on the use of intravenous nicardipine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2013-10-25T02:00:00Z","last_updated_date":"2013-10-25T02:00:00Z","reference_number":"EMA/644174/2013","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-gives-recommendations-use-intravenous-nicardipine_en.pdf"},
    {"id":"41737","name":"EU/3/16/1719 : Public summary of opinion on orphan designation: Cisplatin for the treatment of malignant mesothelioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-10-03T02:00:00Z","last_updated_date":"2016-10-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161719-public-summary-opinion-orphan-designation-cisplatin-treatment-malignant-mesothelioma_en.pdf"},
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    {"id":"41741","name":"Appendix 3 - Pharmacovigilance inspection information collection template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-02-02T16:55:00Z","last_updated_date":"2015-02-02T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-3-pharmacovigilance-inspection-information-collection-template_en.doc"},
    {"id":"41744","name":"Presentation - Implementation of the 2016 Notice on the application of the orphan regulation (Kristina Larsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-05-12T18:21:00Z","last_updated_date":"2017-05-12T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-2016-notice-application-orphan-regulation-kristina-larsson_en.pdf"},
    {"id":"41745","name":"Appendix to the European Medicines Agency Code of Conduct","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-06-21T18:00:00Z","last_updated_date":"2016-06-21T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/appendix-european-medicines-agency-code-conduct_en.pdf"},
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    {"id":"41751","name":"EU/3/16/1781: Public summary of positive opinion for orphan designation of live-attenuated non-replicative Pseudomonas aeruginosa strain expressing large T antigen of Merkel cell polyomavirus for the treatment of Merkel ...","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2016-12-14T13:10:00Z","last_updated_date":"2016-12-14T13:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161781-public-summary-positive-opinion-orphan-designation-live-attenuated-non-replicative-pseudomonas-aeruginosa-strain-expressing-large-t-antigen-merkel-cell-polyomavirus-treatment-merkel_en.pdf"},
    {"id":"41752","name":"Summary - Consultation meeting with stakeholders - Request from EC for advice on the impact on public and animal health of the use of antibiotics in animals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-04-03T03:00:00Z","last_updated_date":"2014-04-03T03:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/summary-consultation-meeting-stakeholders-request-ec-advice-impact-public-and-animal-health-use-antibiotics-animals_en.pdf"},
    {"id":"41753","name":"Final assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium - Revision 2","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-04-11T14:00:00Z","last_updated_date":"2018-04-11T14:00:00Z","reference_number":"EMA/HMPC/750266/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-arctostaphylos-uva-ursi-l-spreng-folium-revision-2_en.pdf"},
    {"id":"41754","name":"Presentation - How the European Medicines Agency interacts with patients and consumers","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-02-15T16:00:00Z","last_updated_date":"2016-02-15T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-european-medicines-agency-interacts-patients-and-consumers_en.pdf"},
    {"id":"41755","name":"Presentation - Increasing access to adverse drug reaction reports on the web (Steven Le Meur) AA","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-01-29T01:00:00Z","last_updated_date":"2015-01-29T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-increasing-access-adverse-drug-reaction-reports-web-steven-le-meur-aa_en.pdf"},
    {"id":"41756","name":"EudraVigilance - European database of suspected adverse reactions related to medicines: user manual for online access via the adrreports.eu portal - Version 2.0","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-11-22T10:30:00Z","last_updated_date":"2017-11-22T10:30:00Z","reference_number":"EMA/754608/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-european-database-suspected-adverse-reactions-related-medicines-user-manual-online-access-adrreportseu-portal-version-20_en.pdf"},
    {"id":"41757","name":"Presentation: Update on new Enpr-EMA Paediatric Antibiotic Clinical Trial Working Group","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2016-06-28T02:00:00Z","last_updated_date":"2016-06-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-new-enpr-ema-paediatric-antibiotic-clinical-trial-working-group_en.pdf"},
    {"id":"41758","name":"Opinion of the CVMP on the establishment of maximum residue limits: Clorsulon","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-09-08T19:00:00Z","last_updated_date":"2014-09-08T19:00:00Z","reference_number":"EMA/CVMP/741367/2013 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-clorsulon_en.pdf-0"},
    {"id":"41759","name":"CHMP summary of positive opinion for Vihuma","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2016-12-16T10:00:00Z","last_updated_date":"2016-12-16T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vihuma_en.pdf"},
    {"id":"41760","name":"Cetirizine: List of nationally authorised medicinal products - PSUSA/00000628/201711","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-07-18T18:24:00Z","last_updated_date":"2018-07-18T18:25:49Z","reference_number":"EMA/490585/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cetirizine-list-nationally-authorised-medicinal-products-psusa00000628201711_en.pdf"},
    {"id":"41762","name":"EU/3/17/1966: Public summary of opinion on orphan designation: N-(bromoacetyl)-3,3-dinitroazetidine for the treatment of small cell lung cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-03-12T01:00:00Z","last_updated_date":"2018-03-12T01:00:00Z","reference_number":"EMA/COMP/840557/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3171966-public-summary-opinion-orphan-designation-n-bromoacetyl-33-dinitroazetidine-treatment-small-cell-lung-cancer_en.pdf"},
    {"id":"41764","name":"User manual E-RS (EXACT-respiratory symptoms): Applicant submission version 3.0","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-04-13T12:40:00Z","last_updated_date":"2015-04-13T12:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/user-manual-e-rs-exact-respiratory-symptoms-applicant-submission-version-30_en.pdf"},
    {"id":"41766","name":"International Cooperation - European Medicines Agency","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2015-05-18T18:17:00Z","last_updated_date":"2015-05-18T18:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/international-cooperation-european-medicines-agency_en.pdf"},
    {"id":"41767","name":"Agenda - PRAC draft agenda of meeting 8-11 July 2013","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2013-07-09T11:10:00Z","last_updated_date":"2013-07-09T11:10:00Z","reference_number":"EMA/PRAC/417172/2013","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-july-2013_en.pdf"},
    {"id":"41768","name":"Biologics Working Party (BWP) ad-hoc influenza working group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2018/2019","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-03-26T12:50:00Z","last_updated_date":"2018-04-30T17:18:00Z","reference_number":"EMA/CHMP/BWP/209019/2018","document_url":"https://www.ema.europa.eu/en/documents/other/biologics-working-party-bwp-ad-hoc-influenza-working-group-amended-european-union-recommendations-seasonal-influenza-vaccine-composition-season-20182019_en.pdf"},
    {"id":"41769","name":"Escherichia coli lysate: List of nationally authorised medicinal products - PSUSA/00001263/201507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-04-06T02:00:00Z","last_updated_date":"2016-10-18T13:42:38Z","reference_number":"EMA/243566/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/escherichia-coli-lysate-list-nationally-authorised-medicinal-products-psusa00001263201507_en.pdf"},
    {"id":"41771","name":"Gentamicin Article-35 referral - Annex I, II, III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/144816/2017","document_url":"https://www.ema.europa.eu/en/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/gentamicin-article-35-referral-annex-i-ii-iii_sv.pdf"}},
    {"id":"41772","name":"Opinions on safety variations/periodic safety update reports adopted at the  CHMP meeting of 20-23 June 2016","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2016-06-30T18:00:00Z","last_updated_date":"2016-06-30T18:00:00Z","reference_number":"EMA/76609/2016","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/opinions-safety-variationsperiodic-safety-update-reports-adopted-chmp-meeting-20-23-june-2016_en.pdf"},
    {"id":"41773","name":"Final list of references supporting the assessment of Cetraria islandica (L.) Acharius s.l., thallus - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2015-02-11T11:45:00Z","last_updated_date":"2015-02-11T11:45:00Z","reference_number":"EMA/HMPC/36865/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-cetraria-islandica-l-acharius-sl-thallus-first-version_en.pdf"},
    {"id":"41774","name":"Agenda - CAT agenda of the 10-12 May 2017 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-05-12T16:00:00Z","last_updated_date":"2017-05-12T16:00:00Z","reference_number":"EMA/CAT/303936/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-10-12-may-2017-meeting_en.pdf"},
    {"id":"41775","name":"EU/3/16/1638: Public summary of opinion on orphan designation: Ubenimex for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2016-05-02T02:00:00Z","last_updated_date":"2016-05-02T02:00:00Z","reference_number":"EMA/COMP/167823/2016","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161638-public-summary-opinion-orphan-designation-ubenimex-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"41777","name":"Overview of comments received on draft Guideline on clinical investigation of medicinal products for the treatment of chronic heart failure (CPMP/EWP/235/95, Rev.2)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2017-09-26T12:25:00Z","last_updated_date":"2017-09-26T12:25:00Z","reference_number":"EMA/547655/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-clinical-investigation-medicinal-products-treatment-chronic-heart-failure-cpmpewp23595-rev2_en.pdf"},
    {"id":"41778","name":"CHMP post-authorisation summary of positive opinion for Cubicin","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/CHMP/670705/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cubicin_en.pdf"},
    {"id":"41779","name":"Presentation - Interaction with patients and consumers: Training session questionnaire results (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2014-04-28T13:40:00Z","last_updated_date":"2014-04-28T13:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interaction-patients-and-consumers-training-session-questionnaire-results-nathalie-bere_en.pdf"},
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    {"id":"41781","name":"Assessment report on Centaurium erythraea Rafn. s.l., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2016-01-27T01:00:00Z","last_updated_date":"2016-01-27T01:00:00Z","reference_number":"EMA/HMPC/277491/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/assessment-report-centaurium-erythraea-rafn-sl-herba_en.pdf"},
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    {"id":"41849","name":"Public statement on Daliresp: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2018-02-06T01:00:00Z","last_updated_date":"2018-02-06T01:00:00Z","reference_number":"EMA/58489/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-daliresp-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"41854","name":"Diacerein: List of nationally authorised medicinal products - PSUSA/0001026/201512","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-07-12T14:00:00Z","last_updated_date":"2016-10-17T20:37:53Z","reference_number":"EMA/483326/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/diacerein-list-nationally-authorised-medicinal-products-psusa0001026201512_en.pdf"},
    {"id":"41855","name":"Presentation - Identifying the future needs for big data in Medicines Regulation (Hans Hillege)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T16:30:00Z","last_updated_date":"2017-01-04T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-identifying-future-needs-big-data-medicines-regulation-hans-hillege_en.pdf"},
    {"id":"41856","name":"European Medicines Agency recommends approval of Daklinza in chronic hepatitis C","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2014-06-27T02:00:00Z","last_updated_date":"2014-06-27T02:00:00Z","reference_number":"EMA/378294/2014","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-medicines-agency-recommends-approval-daklinza-chronic-hepatitis-c_en.pdf"},
    {"id":"41857","name":"Open clinical data - stakeholder quotes","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T17:00:00Z","last_updated_date":"2016-10-25T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/open-clinical-data-stakeholder-quotes_en.pdf"},
    {"id":"41859","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course 25-26 September 2014","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2014-09-24T14:00:00Z","last_updated_date":"2014-09-24T14:00:00Z","reference_number":"Course #14527","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-training-course-25-26-september-2014_en.pdf"},
    {"id":"41860","name":"Final list of references supporting the assessment of Matricaria recutita L., flos and Matricaria recutita L., aetheroleum - First version","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2016-04-05T17:30:00Z","last_updated_date":"2016-04-05T17:30:00Z","reference_number":"EMA/HMPC/55810/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-matricaria-recutita-l-flos-and-matricaria-recutita-l-aetheroleum-first-version_en.pdf"},
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    {"id":"41866","name":"Statement of expenses for candidates","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-08-04T11:00:00Z","last_updated_date":"2018-06-06T12:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/statement-expenses-candidates_en.doc"},
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    {"id":"41871","name":"CHMP summary of positive opinion for Ovaleap","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T18:00:00Z","last_updated_date":"2013-08-01T18:00:00Z","reference_number":"EMA/422789/2013","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ovaleap_en.pdf"},
    {"id":"41872","name":"Summary of transfer of appropriations in the budget 2015 - Management Board meeting: 16-17 December 2015","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-12-18T14:29:00Z","last_updated_date":"2015-12-18T14:29:00Z","reference_number":"EMA/MB/776950/2015","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfer-appropriations-budget-2015-management-board-meeting-16-17-december-2015_en.pdf"},
    {"id":"41874","name":"CHMP post-authorisation summary of positive opinion for Copalia","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2013-06-26T14:00:00Z","last_updated_date":"2013-06-26T14:00:00Z","reference_number":"EMA/CHMP/397192/2013","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-copalia_en.pdf"},
    {"id":"41876","name":"Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201707","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-02-13T12:47:00Z","last_updated_date":"2018-02-13T12:49:00Z","reference_number":"EMA/93869/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/levonorgestrel-ethinylestradiol-ethinylestradiol-combination-pack-list-nationally-authorised-medicinal-products-psusa00010442201707_en.pdf"},
    {"id":"41878","name":"Pharmaceutics International Inc. Article-31 referral – CHMP assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2016-12-14T01:00:00Z","last_updated_date":"2016-12-14T01:00:00Z","reference_number":"EMA/732186/2016","document_url":"https://www.ema.europa.eu/en/documents/referral/pharmaceutics-international-inc-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"41879","name":"Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-02-28T13:30:00Z","last_updated_date":"2018-02-28T13:30:00Z","reference_number":"CPMP/EWP/553/95 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf"},
    {"id":"41881","name":"EU/3/16/1809: Public summary of opinion on orphan designation: [5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride for the treatment of Cockayne syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2017-07-11T02:00:00Z","last_updated_date":"2017-07-11T02:00:00Z","reference_number":"EMA/5008/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161809-public-summary-opinion-orphan-designation-5101520-tetrakis4-carboxyphenyl-21h23h-porphinemanganeseiii-chloride-treatment-cockayne-syndrome_en.pdf"},
    {"id":"41882","name":"Workshop report - Best expertise vs conflicts of interests: Striking the right balance","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2013-10-02T17:15:00Z","last_updated_date":"2013-10-02T17:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/workshop-report-best-expertise-vs-conflicts-interests-striking-right-balance_en.pdf"},
    {"id":"41883","name":"Presentation - Update on implementation of public hearings at the PRAC (Isabelle Moulon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-09-29T18:30:00Z","last_updated_date":"2015-09-29T18:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-implementation-public-hearings-prac-isabelle-moulon_en.pdf"},
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    {"id":"41889","name":"Semler - Marketing authorisations which are recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à -vis the EU reference medicinal product has been established as adopted by t...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2016-07-22T14:00:00Z","reference_number":"EMA/499815/2016","document_url":"https://www.ema.europa.eu/en/documents/other/semler-marketing-authorisations-which-are-recommended-maintenance-and-marketing-authorisation-applications-which-bioequivalence-vis-vis-eu-reference-medicinal-product-has-been-established-adopted-t_en.pdf"},
    {"id":"41891","name":"Polymyxin Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2015-01-05T01:00:00Z","last_updated_date":"2015-01-05T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/polymyxin-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/polymyxin-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/polymyxin-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/polymyxin-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/polymyxin-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/polymyxin-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/polymyxin-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/polymyxin-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/polymyxin-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/polymyxin-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/polymyxin-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/polymyxin-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/polymyxin-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/polymyxin-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/polymyxin-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/polymyxin-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/polymyxin-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/polymyxin-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/polymyxin-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/polymyxin-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/polymyxin-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/polymyxin-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/polymyxin-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/polymyxin-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/polymyxin-article-31-referral-annex-i_no.pdf"}},
    {"id":"41892","name":"Caraway fruit - Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2015-10-20T12:45:00Z","last_updated_date":"2016-02-17T12:05:00Z","reference_number":"EMA/498568/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/caraway-fruit-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/caraway-fruit-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/caraway-fruit-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/caraway-fruit-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/caraway-fruit-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/caraway-fruit-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/caraway-fruit-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/caraway-fruit-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/caraway-fruit-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/caraway-fruit-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/caraway-fruit-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/caraway-fruit-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/caraway-fruit-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/caraway-fruit-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/caraway-fruit-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/caraway-fruit-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/caraway-fruit-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/caraway-fruit-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/caraway-fruit-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/caraway-fruit-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/caraway-fruit-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/caraway-fruit-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/caraway-fruit-summary-public_sv.pdf"}},
    {"id":"41893","name":"Final list of references supporting the assessment of Paeonia lactiflora Pallas, radix (Paeoniae radix alba)","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2017-04-25T16:47:00Z","last_updated_date":"2017-04-25T16:47:00Z","reference_number":"EMA/HMPC/150788/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-paeonia-lactiflora-pallas-radix-paeoniae-radix-alba_en.pdf"},
    {"id":"41898","name":"EU/3/15/1464: Public summary of positive opinion for orphan designation of  autologous adipose tissue-derived stromal vascular fraction cells for the treatment of systemic sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2015-05-11T02:00:00Z","last_updated_date":"2015-05-11T02:00:00Z","reference_number":"EMA/COMP/125714/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3151464-public-summary-positive-opinion-orphan-designation-autologous-adipose-tissue-derived-stromal-vascular-fraction-cells-treatment-systemic-sclerosis_en.pdf"},
    {"id":"41899","name":"EU/3/14/1329: Public summary of opinion on orphan designation: Variant of recombinant human fibroblast growth factor 19 for the treatment of primary biliary cirrhosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2014-10-02T02:00:00Z","last_updated_date":"2014-10-02T02:00:00Z","reference_number":"EMA/COMP/440234/2014","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3141329-public-summary-opinion-orphan-designation-variant-recombinant-human-fibroblast-growth-factor-19-treatment-primary-biliary-cirrhosis_en.pdf"},
    {"id":"41900","name":"Scientific recommendation on classification of advanced therapy medicinal products: Genetically engineered AAV8 that lacks all of the viral protein-coding sequences and encodes a human MTM1 complementary DNA","type":"report","status":"unknown","consultation_date":"","first_published_date":"2017-02-28T14:45:00Z","last_updated_date":"2017-02-28T14:45:00Z","reference_number":"EMA/126546/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-genetically-engineered-aav8-lacks-all-viral-protein-coding-sequences-and-encodes-human-mtm1-complementary-dna_en.pdf"},
    {"id":"41902","name":"Scientific recommendation on classification of advanced therapy medicinal products: Plasmid encoding a mutation-inactivated E7-E6 fusion protein from Human Papillomavirus 16 linked to the human chemokine hMIP-1a via a di...","type":"report","status":"unknown","consultation_date":"","first_published_date":"2015-03-02T17:00:00Z","last_updated_date":"2015-03-02T17:00:00Z","reference_number":"EMA/107652/2015","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-plasmid-encoding-mutation-inactivated-e7-e6-fusion-protein-human-papillomavirus-16-linked-human-chemokine-hmip-1a-di_en.pdf"},
    {"id":"41903","name":"CHMP ORGAM agenda for the meeting on 16 July 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-07-31T17:30:00Z","last_updated_date":"2018-07-31T17:30:00Z","reference_number":"EMA/CHMP/492328/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-16-july-2018_en.pdf"},
    {"id":"41905","name":"Human medicines highlights - March 2015","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2015-04-01T17:25:00Z","last_updated_date":"2015-04-01T17:25:00Z","reference_number":"Issue 73","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-march-2015_en.pdf"},
    {"id":"41906","name":"Defect with Buccolam oral syringes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-01-15T17:00:00Z","last_updated_date":"2018-01-15T17:00:00Z","reference_number":"EMA/12612/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/defect-buccolam-oral-syringes_en.pdf"},
    {"id":"41908","name":"Micro Therapeutic Research Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2017-07-10T02:00:00Z","last_updated_date":"2017-07-10T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/micro-therapeutic-research-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"41910","name":"EMA fees query form","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2015-04-20T13:50:00Z","last_updated_date":"2015-05-18T12:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/ema-fees-query-form_en.pdf"},
    {"id":"41914","name":"Scientific recommendation on classification of advanced therapy medicinal products: Freshly isolated autologous CD34+","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-01-03T14:41:00Z","last_updated_date":"2018-01-03T14:41:00Z","reference_number":"EMA/751584/2017","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-freshly-isolated-autologous-cd34_en.pdf"},
    {"id":"41916","name":"Final list of references supporting the assessment of Marrubium vulgare L., herba  - First version","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T17:00:00Z","last_updated_date":"2013-08-01T17:00:00Z","reference_number":"EMA/HMPC/604272/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-marrubium-vulgare-l-herba-first-version_en.pdf"},
    {"id":"41917","name":"Instruction guide to support the e-learning training module IT-M2 - E2B(R3)/E2B(R2) XML testing - Version 1.0","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-06-26T14:00:00Z","last_updated_date":"2017-06-26T14:00:00Z","reference_number":"EMA/12076/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/instruction-guide-support-e-learning-training-module-it-m2-e2br3e2br2-xml-testing-version-10_en.pdf"},
    {"id":"41920","name":"Presentation - EMA Technical Anonymisation Group (TAG) - EMA's PCWP and HCPWP joint meeting (Monica Dias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-technical-anonymisation-group-tag-emas-pcwp-and-hcpwp-joint-meeting-monica-dias_en.pdf"},
    {"id":"41923","name":"EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-07-21T02:00:00Z","last_updated_date":"2017-07-21T02:00:00Z","reference_number":"EMA/457616/2017 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/emas-final-opinion-confirms-restrictions-use-linear-gadolinium-agents-body-scans_en.pdf"},
    {"id":"41924","name":"Influenza vaccine (surface antigen, inactivated): CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001744/201504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-10-17T18:39:16Z","reference_number":"PSUSA/00001744/201504","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001744201504_en.pdf"},
    {"id":"41925","name":"CHMP post-authorisation summary of positive opinion for Aloxi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2015-01-23T01:00:00Z","last_updated_date":"2015-01-23T01:00:00Z","reference_number":"EMA/CHMP/39940/2015","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-aloxi_en.pdf"},
    {"id":"41927","name":"Public bulletin: Veterinary pharmacovigilance 2014","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-03-03T10:15:00Z","last_updated_date":"2015-03-03T10:15:00Z","reference_number":"EMA/CVMP/793263/2014","document_url":"https://www.ema.europa.eu/en/documents/other/public-bulletin-veterinary-pharmacovigilance-2014_en.pdf"},
    {"id":"41928","name":"Deoxycholic acid: List of nationally authorised products - PSUSA/00010525/201710","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-08-14T13:00:00Z","last_updated_date":"2018-08-14T13:00:00Z","reference_number":"EMA/PRAC/380270/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/deoxycholic-acid-list-nationally-authorised-products-psusa00010525201710_en.pdf"},
    {"id":"41929","name":"Final guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2016-02-11T10:40:00Z","last_updated_date":"2016-02-11T10:40:00Z","reference_number":"EMA/CHMP/BPWP/1619/1999 rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/final-guideline-core-smpc-human-plasma-derived-and-recombinant-coagulation-factor-viii-products-revision-2_en.pdf"},
    {"id":"41931","name":"Presentation - Industry and assessors' joint training on how to improve to improve the content of PSURs - PSUR roadmap: joint industry/assessor training","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-10-18T02:00:00Z","last_updated_date":"2017-10-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-and-assessors-joint-training-how-improve-improve-content-psurs-psur-roadmap-joint-industryassessor-training_en.pdf"},
    {"id":"41934","name":"CVMP post-authorisation summary of positive opinion for Leucogen","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-06-22T18:00:00Z","last_updated_date":"2018-06-22T18:00:00Z","reference_number":"EMA/CVMP/113131/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-leucogen_en.pdf"},
    {"id":"41936","name":"Overview of comments received on ‘Draft good practice guide on risk minimisation and prevention of medication errors’ (EMA/606103/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-11-27T11:00:00Z","last_updated_date":"2015-11-27T11:00:00Z","reference_number":"EMA/352692/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-good-practice-guide-risk-minimisation-and-prevention-medication-errors-ema6061032014_en.pdf"},
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    {"id":"41968","name":"New medicine for rare neurodegenerative disorder in children","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/CHMP/250656/2017","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-rare-neurodegenerative-disorder-children_en.pdf"},
    {"id":"41970","name":"Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VI – Management and reporting of adverse reactions to medicinal products (EMA/873138/2011 Rev. 2)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2017-08-02T12:00:00Z","last_updated_date":"2017-08-02T12:00:00Z","reference_number":"EMA/847133/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/comments-received-public-consultation-good-pharmacovigilance-practices-gvp-gvp-module-vi-management-and-reporting-adverse-reactions-medicinal-products-ema8731382011-rev-2_en.pdf"},
    {"id":"41971","name":"Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2016-03-30T02:00:00Z","last_updated_date":"2016-10-18T14:01:10Z","reference_number":"EMA/230130/2016","document_url":"https://www.ema.europa.eu/en/documents/psusa/cabergoline-list-nationally-authorised-medicinal-products-psusa00000477201503_en.pdf"},
    {"id":"41972","name":"Sarah Nevitt (CV)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T17:01:00Z","last_updated_date":"2017-10-31T17:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sarah-nevitt-cv_en.pdf"},
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    {"id":"41979","name":"Overview of comments received on VICH guideline on electronic exchange of documents electronic file format (GL53)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2015-05-29T12:30:00Z","last_updated_date":"2015-05-29T12:30:00Z","reference_number":"VICH GL-53","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-vich-guideline-electronic-exchange-documents-electronic-file-format-gl53_en.pdf"},
    {"id":"41982","name":"Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-12T16:38:00Z","last_updated_date":"2018-01-12T16:40:00Z","reference_number":"EMA/11926/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gynaecological-indication-labour-induction-list-nationally-authorised-medicinal-products-psusa00010353201705_en.pdf"},
    {"id":"41983","name":"Presentation - Key points from session 3: industry perspective (Karri Penttila)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-08-03T02:00:00Z","last_updated_date":"2015-08-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-points-session-3-industry-perspective-karri-penttila_en.pdf"},
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    {"id":"41994","name":"Presentation - European Medicines Agency (EMA)-Heads of Medicines Agency (HMA) collaboration on shortages and availability of medicines - EMA's PCWP and HCPWP joint meeting (Rosa Gonzalez-Quevedo, Annette Byrholt Hansen,...","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T02:00:00Z","last_updated_date":"2018-06-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-ema-heads-medicines-agency-hma-collaboration-shortages-and-availability-medicines-emas-pcwp-and-hcpwp-joint-meeting-rosa-gonzalez-quevedo-annette-byrholt-hansen_en.pdf"},
    {"id":"41995","name":"Recommendation for maintenance of orphan designation at the time of addition of a new indication to the marketing authorisation: Imbruvica (ibrutinib) for the treatment of lymphoplasmacytic lymphoma","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2015-09-08T02:00:00Z","last_updated_date":"2015-09-14T02:00:00Z","reference_number":"EMA/COMP/396537/2015","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-addition-new-indication-marketing-authorisation-imbruvica-ibrutinib-treatment-lymphoplasmacytic-lymphoma_en.pdf"},
    {"id":"41997","name":"Presentation - Molecular comparison of ulcerative colitis different in age and extent of disease by colon biopsy mRNA expression profiling (Richard Strauss)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2015-07-09T02:00:00Z","last_updated_date":"2015-07-09T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-molecular-comparison-ulcerative-colitis-different-age-and-extent-disease-colon-biopsy-mrna-expression-profiling-richard-strauss_en.pdf"},
    {"id":"41998","name":"Halofantrine: List of nationally authorised medicinal products - PSUSA/00001586/201705","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-01-19T13:00:00Z","last_updated_date":"2018-01-19T13:00:00Z","reference_number":"EMA/21173/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/halofantrine-list-nationally-authorised-medicinal-products-psusa00001586201705_en.pdf"},
    {"id":"41999","name":"CHMP summary of positive opinion for Thorinane","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T14:00:00Z","last_updated_date":"2019-10-24T14:00:00Z","reference_number":"EMA/CHMP/482415/2016","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-thorinane_en.pdf"},
    {"id":"42003","name":"Public statement on Pandemrix: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2015-10-27T15:00:00Z","last_updated_date":"2015-10-27T15:00:00Z","reference_number":"EMA/656472/2015","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pandemrix-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"42005","name":"Thyme: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2016-10-14T02:00:00Z","last_updated_date":"2016-10-14T02:00:00Z","reference_number":"EMA/307113/20166","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/thyme-summary-public_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/herbal-summary/thyme-summary-public_bg.pdf","es":"https://www.ema.europa.eu/es/documents/herbal-summary/thyme-summary-public_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/herbal-summary/thyme-summary-public_cs.pdf","da":"https://www.ema.europa.eu/da/documents/herbal-summary/thyme-summary-public_da.pdf","de":"https://www.ema.europa.eu/de/documents/herbal-summary/thyme-summary-public_de.pdf","et":"https://www.ema.europa.eu/et/documents/herbal-summary/thyme-summary-public_et.pdf","el":"https://www.ema.europa.eu/el/documents/herbal-summary/thyme-summary-public_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/herbal-summary/thyme-summary-public_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/herbal-summary/thyme-summary-public_hr.pdf","it":"https://www.ema.europa.eu/it/documents/herbal-summary/thyme-summary-public_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/herbal-summary/thyme-summary-public_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/herbal-summary/thyme-summary-public_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/herbal-summary/thyme-summary-public_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/herbal-summary/thyme-summary-public_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/herbal-summary/thyme-summary-public_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/herbal-summary/thyme-summary-public_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/herbal-summary/thyme-summary-public_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/herbal-summary/thyme-summary-public_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/herbal-summary/thyme-summary-public_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/herbal-summary/thyme-summary-public_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/herbal-summary/thyme-summary-public_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/herbal-summary/thyme-summary-public_sv.pdf"}},
    {"id":"42006","name":"Presentation - Anthelmintic resistance in Europe - Cattle, sheep and horses (Anita Bottger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T01:00:00Z","last_updated_date":"2017-02-10T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-anthelmintic-resistance-europe-cattle-sheep-and-horses-anita-bottger_en.pdf"},
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    {"id":"42011","name":"Overview of comments received on Draft Revision of the Guideline on epidemiological data on blood transmissible infections (EMA/CHMP/BWP/548524/2008)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-03-01T11:13:01Z","last_updated_date":"2016-03-01T11:13:01Z","reference_number":"EMA/651460/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-revision-guideline-epidemiological-data-blood-transmissible-infections-emachmpbwp5485242008_en.pdf"},
    {"id":"42012","name":"Agenda - PRAC draft agenda of meeting 25-29 September 2017","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2017-09-25T19:05:00Z","last_updated_date":"2017-09-25T19:05:00Z","reference_number":"EMA/PRAC/634126/2017","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-25-29-september-2017_en.pdf"},
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    {"id":"42018","name":"Annual renewal assessment report template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T15:00:00Z","last_updated_date":"2017-08-04T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/annual-renewal-assessment-report-template_en.docx"},
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    {"id":"42026","name":"Agenda - Multi-stakeholders Advanced Therapy Medicinal Products (ATMPs) Expert Meeting: exploring solutions to foster ATMPs’ development and access to patients in Europe","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2016-05-13T02:00:00Z","last_updated_date":"2016-05-13T02:00:00Z","reference_number":"EMA/323946/2016","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-multi-stakeholders-advanced-therapy-medicinal-products-atmps-expert-meeting-exploring-solutions-foster-atmps-development-and-access-patients-europe_en.pdf"},
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    {"id":"42088","name":"Desmopressin: List of nationally authorised medicinal products - PSUSA/00000964/201712","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-14T16:26:00Z","last_updated_date":"2018-09-14T16:31:42Z","reference_number":"EMA/PRAC/628699/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/desmopressin-list-nationally-authorised-medicinal-products-psusa00000964201712_en.pdf"},
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    {"id":"42098","name":"Public statement on Angiox: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-09-14T16:52:00Z","last_updated_date":"2018-09-14T16:52:00Z","reference_number":"EMA/517907/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-angiox-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"42100","name":"Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-09-14T16:44:00Z","last_updated_date":"2018-09-14T16:47:00Z","reference_number":"EMA/622923/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/levonorgestrel-ethinylestradiol-ethinylestradiol-combination-pack-list-nationally-authorised-medicinal-products-psusa00010442201801_en.pdf"},
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    {"id":"42102","name":"New medicine to treat infections in adults","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-09-21T02:00:00Z","last_updated_date":"2018-09-21T02:00:00Z","reference_number":"EMA/CHMP/640311/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-treat-infections-adults_en.pdf"},
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    {"id":"42129","name":"CHMP post-authorisation summary of positive opinion for Trelegy Ellipta","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-09-21T02:00:00Z","last_updated_date":"2018-09-21T02:00:00Z","reference_number":"EMA/CHMP/652421/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trelegy-ellipta_en.pdf"},
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    {"id":"42149","name":"EU inspection finds Zhejiang Huahai site non-compliant for manufacture of valsartan","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-09-28T17:00:00Z","last_updated_date":"2018-09-28T17:00:00Z","reference_number":"EMA/671501/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-inspection-finds-zhejiang-huahai-site-non-compliant-manufacture-valsartan_en.pdf"},
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    {"id":"42234","name":"A common data model for Europe - Why? Which? How? - Workshop report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-10-08T17:21:00Z","last_updated_date":"2018-10-08T17:21:00Z","reference_number":"EMA/614680/2018","document_url":"https://www.ema.europa.eu/en/documents/report/common-data-model-europe-why-which-how-workshop-report_en.pdf"},
    {"id":"42236","name":"Overview of comments received on ICH guideline Q3D (R1) on elemental impurities (EMA/CHMP/ICH/353369/2013) - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-10-09T11:27:00Z","last_updated_date":"2018-10-09T11:27:00Z","reference_number":"EMA/619895/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-guideline-q3d-r1-elemental-impurities-emachmpich3533692013-first-version_en.pdf"},
    {"id":"42237","name":"Minutes of the CAT written procedure 15-17 August 2018","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2018-10-09T11:47:00Z","last_updated_date":"2018-10-09T11:47:00Z","reference_number":"EMA/CAT/568714/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-written-procedure-15-17-august-2018_en.pdf"},
    {"id":"42238","name":"Human medicines highlights - October 2018","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-10-09T12:58:00Z","last_updated_date":"2018-10-09T12:58:00Z","reference_number":"Issue 115","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-october-2018_en.pdf"},
    {"id":"42242","name":"EMA Brexit Preparedness Business Continuity Plan – Phase 3 implementation plan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-10-09T15:13:00Z","last_updated_date":"2018-10-09T15:13:00Z","reference_number":"EMA/701082/2018","document_url":"https://www.ema.europa.eu/en/documents/other/ema-brexit-preparedness-business-continuity-plan-phase-3-implementation-plan_en.pdf"},
    {"id":"42243","name":"Cut-off dates for UK Rapporteurship appointments for pre and post authorisation procedures for centrally authorised products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-10-09T15:52:00Z","last_updated_date":"2018-10-09T15:52:00Z","reference_number":"EMA/637235/2018","document_url":"https://www.ema.europa.eu/en/documents/other/cut-dates-uk-rapporteurship-appointments-pre-and-post-authorisation-procedures-centrally-authorised-products_en.pdf"},
    {"id":"42244","name":"Update on EMA’s Brexit preparedness","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-09T16:18:00Z","last_updated_date":"2018-10-09T16:18:00Z","reference_number":"EMA/689345/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-emas-brexit-preparedness_en.pdf"},
    {"id":"42251","name":"Agenda - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-10-09T18:14:00Z","last_updated_date":"2018-10-23T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory-science-2025_en.pdf"},
    {"id":"42252","name":"Public statement on Imatinib Teva B.V.: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-10-09T19:07:00Z","last_updated_date":"2018-10-09T19:07:00Z","reference_number":"EMA/293981/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-imatinib-teva-bv-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"42254","name":"Public statement on Raplixa: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T11:01:00Z","last_updated_date":"2018-10-10T11:01:00Z","reference_number":"EMA/421791/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-raplixa-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"42255","name":"Final Opinion of the HMPC on a Community herbal monograph on Vitex agnus-castus L., fructus - Revision 1","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T11:16:00Z","last_updated_date":"2018-10-10T11:16:00Z","reference_number":"EMA/HMPC/M/H/0218","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-community-herbal-monograph-vitex-agnus-castus-l-fructus-revision-1_en.pdf"},
    {"id":"42256","name":"Final European Union herbal monograph on Vitex agnus-castus L., fructus - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T11:18:00Z","last_updated_date":"2018-10-10T11:18:00Z","reference_number":"EMA/HMPC/606742/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-vitex-agnus-castus-l-fructus-revision-1_en.pdf"},
    {"id":"42257","name":"Final assessment report on Vitex agnus-castus L., fructus - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T11:21:00Z","last_updated_date":"2018-10-10T11:21:00Z","reference_number":"EMA/HMPC/606741/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-vitex-agnus-castus-l-fructus-revision-1_en.pdf"},
    {"id":"42258","name":"Final list of references supporting the assessment of Vitex agnus-castus L., fructus - Revision 1","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T11:26:00Z","last_updated_date":"2018-10-10T11:26:00Z","reference_number":"EMA/HMPC/795807/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-vitex-agnus-castus-l-fructus-revision-1_en.pdf"},
    {"id":"42259","name":"EU/3/18/2044: Public summary of orphan designation: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded for the treatment of graft-versus-host disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T12:48:00Z","last_updated_date":"2018-10-10T12:48:00Z","reference_number":"EMA/453202/2018 Corr. 2","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182044-public-summary-orphan-designation-allogeneic-bone-marrow-derived-mesenchymal-stromal-cells-ex-vivo-expanded-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"42260","name":"Final European Union herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T12:53:00Z","last_updated_date":"2018-10-10T12:53:00Z","reference_number":"EMA/HMPC/753041/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-revision-1_en.pdf"},
    {"id":"42261","name":"Final opinion of the HMPC on a Community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T12:56:00Z","last_updated_date":"2018-10-10T12:56:00Z","reference_number":"EMA/HMPC/490645/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-community-herbal-monograph-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-revision-1_en.pdf"},
    {"id":"42262","name":"Final assessment report on Oenothera biennis L., Oenothera lamarckiana L., oleum - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T12:58:00Z","last_updated_date":"2018-10-10T12:58:00Z","reference_number":"EMA/HMPC/753042/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-revision-1_en.pdf"},
    {"id":"42263","name":"Final list of references supporting the assessment of Oenothera biennis L.; Oenothera lamarckiana L., oleum - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T13:00:00Z","last_updated_date":"2018-10-10T13:00:00Z","reference_number":"EMA/HMPC/753040/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-revision-1_en.pdf"},
    {"id":"42269","name":"Public statement on Raplixa: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T14:08:00Z","last_updated_date":"2018-10-10T14:08:00Z","reference_number":"EMA/421791/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-raplixa-withdrawal-marketing-authorisation-european-union_en.pdf-0"},
    {"id":"42271","name":"Presentation - Negotiations with the United Kingdom (Stefan Fuehring)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T16:09:00Z","last_updated_date":"2018-10-10T16:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-negotiations-united-kingdom-stefan-fuehring_en.pdf"},
    {"id":"42272","name":"Presentation - Operational preparedness for Brexit and next phase of the Business continuity plan (BCP) (Noël Wathion)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T16:14:00Z","last_updated_date":"2018-10-10T16:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-operational-preparedness-brexit-and-next-phase-business-continuity-plan-bcp-noel-wathion_en.pdf"},
    {"id":"42273","name":"Presentation - Update on European Medicines Agency Committees’ Operational Preparedness (Monica Dias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T16:17:00Z","last_updated_date":"2018-10-10T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-european-medicines-agency-committees-operational-preparedness-monica-dias_en.pdf"},
    {"id":"42274","name":"Presentation - European Medicines Agency industry survey summary results (Alberto Jimenez,)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T16:18:00Z","last_updated_date":"2018-10-10T16:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agency-industry-survey-summary-results-alberto-jimenez_en.pdf"},
    {"id":"42275","name":"Presentation - Joint human medicines industry presentation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T16:22:00Z","last_updated_date":"2018-10-10T16:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-human-medicines-industry-presentation_en.pdf"},
    {"id":"42276","name":"Presentation - Joint veterinary medicines industry presentation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-10T16:24:00Z","last_updated_date":"2018-10-10T16:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-veterinary-medicines-industry-presentation_en.pdf"},
    {"id":"42284","name":"EU/3/18/2053: Public summary of opinion on orphan designation: Tamibarotene for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T21:51:00Z","last_updated_date":"2018-10-10T21:51:00Z","reference_number":"EMA/452780/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182053-public-summary-opinion-orphan-designation-tamibarotene-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"42285","name":"EU/3/18/2045: Public summary of opinion on orphan designation: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T22:03:00Z","last_updated_date":"2018-10-10T22:03:00Z","reference_number":"EMA/468680/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182045-public-summary-opinion-orphan-designation-ex-vivo-fused-autologous-human-bone-marrow-derived-mesenchymal-stem-cell-allogenic-human-myoblast-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"42286","name":"EU/3/18/2051: Public summary of opinion on orphan designation: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA for treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-10T22:11:00Z","last_updated_date":"2018-10-10T22:11:00Z","reference_number":"EMA/468719/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182051-public-summary-opinion-orphan-designation-synthetic-antisense-oligonucleotide-directed-against-human-dystrophin-pre-mrna-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"42287","name":"EU/3/18/2043: Public summary of opinion on orphan designation: Combination of carboplatin and sodium valproate for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T09:36:00Z","last_updated_date":"2018-10-11T09:36:00Z","reference_number":"EMA/437307/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182043-public-summary-opinion-orphan-designation-combination-carboplatin-and-sodium-valproate-treatment-glioma_en.pdf"},
    {"id":"42288","name":"EU/3/18/2054: Public summary of opinion on orphan designation: Tetracosactide for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T09:47:00Z","last_updated_date":"2018-10-11T09:47:00Z","reference_number":"EMA/468032/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182054-public-summary-opinion-orphan-designation-tetracosactide-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"42289","name":"EU/3/18/2050: Public summary of opinion on orphan designation: Selumetinib for the treatment of neurofibromatosis type 1","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T09:56:00Z","last_updated_date":"2018-10-11T09:56:00Z","reference_number":"EMA/464911/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182050-public-summary-opinion-orphan-designation-selumetinib-treatment-neurofibromatosis-type-1_en.pdf"},
    {"id":"42290","name":"EU/3/18/2042: Public summary of opinion on orphan designation: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene for the treatment of achromatopsia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T10:03:00Z","last_updated_date":"2018-10-11T10:03:00Z","reference_number":"EMA/470290/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182042-public-summary-opinion-orphan-designation-adenovirus-associated-viral-vector-serotype-28-containing-human-cnga3-gene-treatment-achromatopsia_en.pdf"},
    {"id":"42292","name":"EU/3/18/2048: Public summary of opinion on orphan designation: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene for the treatment of congenital alpha-1 antitrypsin deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T11:35:00Z","last_updated_date":"2018-10-11T11:35:00Z","reference_number":"EMA/454554/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182048-public-summary-opinion-orphan-designation-n-acetylgalactosamine-conjugated-synthetic-double-stranded-oligomer-specific-serpin-family-member-1-gene-treatment-congenital-alpha-1-antitrypsin_en.pdf"},
    {"id":"42293","name":"EU/3/18/2052: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T11:41:00Z","last_updated_date":"2018-10-11T11:41:00Z","reference_number":"EMA/451140/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182052-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-lactate-dehydrogenase-mrna-and-containing-four-modified-nucleosides-which-form_en.pdf"},
    {"id":"42294","name":"EU/3/18/2046: Public summary of opinion on orphan designation: Givinostat for the treatment of Becker muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T11:49:00Z","last_updated_date":"2018-10-11T11:49:00Z","reference_number":"EMA/465065/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182046-public-summary-opinion-orphan-designation-givinostat-treatment-becker-muscular-dystrophy_en.pdf"},
    {"id":"42295","name":"Public summary of negative opinion for orphan designation of melatonin for the treatment of non-traumatic subarachnoid haemorrhage","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T12:03:00Z","last_updated_date":"2018-10-11T12:03:00Z","reference_number":"EMA/138943/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-melatonin-treatment-non-traumatic-subarachnoid-haemorrhage_en.pdf"},
    {"id":"42296","name":"EU/3/16/1800: Public summary of opinion on orphan designation: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 for the treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T12:08:00Z","last_updated_date":"2018-10-11T12:08:00Z","reference_number":"EMA/454552/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3161800-public-summary-opinion-orphan-designation-recombinant-human-ectonucleotide-pyrophosphatasephosphodiesterase-1-fused-fc-fragment-igg1-treatment-ectonucleotide-pyrophosphatasephosphodiesterase_en.pdf"},
    {"id":"42297","name":"EU/3/18/2047: Public summary of opinion on orphan designation: Liposomal mannose-1-phosphate for the treatment of phosphomannomutase 2-congenital disorder of glycosylation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T12:20:00Z","last_updated_date":"2018-10-11T12:20:00Z","reference_number":"EMA/438554/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182047-public-summary-opinion-orphan-designation-liposomal-mannose-1-phosphate-treatment-phosphomannomutase-2-congenital-disorder-glycosylation_en.pdf"},
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    {"id":"42317","name":"Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201802","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T13:35:00Z","last_updated_date":"2018-10-12T13:35:00Z","reference_number":"EMA/699401/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-hydrochloride-chlordiazepoxide-list-nationally-authorised-medicinal-products-psusa00000171201802_en.pdf"},
    {"id":"42318","name":"Nafarelin: List of nationally authorised medicinal products - PSUSA/00002105/201802","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T13:45:00Z","last_updated_date":"2018-10-12T13:45:00Z","reference_number":"EMA/699451/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/nafarelin-list-nationally-authorised-medicinal-products-psusa00002105201802_en.pdf"},
    {"id":"42319","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 October 2018","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T14:42:00Z","last_updated_date":"2018-10-12T14:42:00Z","reference_number":"EMA/CVMP/677247/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-9-11-october-2018_en.pdf"},
    {"id":"42320","name":"Argatroban: List of nationally authorised medicinal products - PSUSA/00009057/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T13:50:00Z","last_updated_date":"2018-10-12T13:50:00Z","reference_number":"EMA/701236/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/argatroban-list-nationally-authorised-medicinal-products-psusa00009057201801_en.pdf"},
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    {"id":"42331","name":"Presentation – Feedback on EudraVigilance & new functionalities (Anja van Haren, Sabine Brosch, F. Domergue)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T16:33:00Z","last_updated_date":"2018-10-12T16:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-eudravigilance-new-functionalities-anja-van-haren-sabine-brosch-f-domergue_en.pdf"},
    {"id":"42332","name":"Presentation – Issues and update from the CMDh (Kora Doorduyn-van der Stoep)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T17:22:00Z","last_updated_date":"2018-10-12T17:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-issues-and-update-cmdh-kora-doorduyn-van-der-stoep_en.pdf"},
    {"id":"42333","name":"Presentation – EudraVigilance registration updates (Oana Agheorghiesei)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T17:25:00Z","last_updated_date":"2018-10-12T17:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-registration-updates-oana-agheorghiesei_en.pdf"},
    {"id":"42334","name":"Presentation – UK’s withdrawal from the EU: Preparedness activities update (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T17:27:00Z","last_updated_date":"2018-10-12T17:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-uks-withdrawal-eu-preparedness-activities-update-marie-helene-pinheiro_en.pdf"},
    {"id":"42335","name":"OMS Data Quality Standard","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-12T17:56:00Z","last_updated_date":"2018-10-12T17:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/oms-data-quality-standard_en.pdf"},
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    {"id":"42338","name":"Iloprost (iv solution): List of nationally authorised medicinal products - PSUSA/00009190/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-10-15T10:24:00Z","last_updated_date":"2018-10-15T10:24:00Z","reference_number":"EMA/PRAC/710616/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/iloprost-iv-solution-list-nationally-authorised-medicinal-products-psusa00009190201801_en.pdf"},
    {"id":"42339","name":"EU authorities take further action in ongoing review of sartans","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-15T12:15:00Z","last_updated_date":"2018-10-15T12:15:00Z","reference_number":"EMA/703416/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-authorities-take-further-action-ongoing-review-sartans_en.pdf"},
    {"id":"42340","name":"EU authorities take further action in ongoing review of sartans","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-15T12:15:00Z","last_updated_date":"2018-10-15T12:15:00Z","reference_number":"EMA/703416/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-authorities-take-further-action-ongoing-review-sartans_en.pdf-0"},
    {"id":"42342","name":"Sales of veterinary antimicrobial agents in 30 European countries in 2016 - Trends from 2010 to 2016 Eighth ESVAC report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-10-15T14:40:00Z","last_updated_date":"2018-10-15T14:40:00Z","reference_number":"EMA/275982/2018","document_url":"https://www.ema.europa.eu/en/documents/report/sales-veterinary-antimicrobial-agents-30-european-countries-2016-trends-2010-2016-eighth-esvac-report_en.pdf"},
    {"id":"42344","name":"Sales of antibiotics for use in food-producing animals drop across the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-15T14:53:00Z","last_updated_date":"2018-10-15T14:53:00Z","reference_number":"EMA/CVMP/683413/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/sales-antibiotics-use-food-producing-animals-drop-across-eu_en.pdf"},
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    {"id":"42349","name":"Lomustine: List of nationally authorised medicinal products - PSUSA/00001902/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-10-16T16:22:00Z","last_updated_date":"2018-10-16T16:22:00Z","reference_number":"EMA/693804/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/lomustine-list-nationally-authorised-medicinal-products-psusa00001902201801_en.pdf"},
    {"id":"42351","name":"Isoflurane (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2018-10-16T17:11:00Z","last_updated_date":"2018-10-16T17:11:00Z","reference_number":"EMA/CVMP/60621/2018","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/isoflurane-porcine-species-european-public-maximum-residue-limit-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"42353","name":"Opinion of the CVMP on the establishment of maximum residue limits: Isoflurane","type":"mrl-opinion","status":"unknown","consultation_date":"","first_published_date":"2018-10-17T10:40:00Z","last_updated_date":"2018-10-17T10:40:00Z","reference_number":"EMA/CVMP/103565/2018","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-maximum-residue-limits-isoflurane_en.pdf"},
    {"id":"42357","name":"Evening primrose oil: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2018-10-17T16:49:00Z","last_updated_date":"2018-10-17T16:49:00Z","reference_number":"EMA/422144/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/evening-primrose-oil-summary-public_en.pdf"},
    {"id":"42358","name":"Ciprofloxacin (topical use): List of nationally authorised medicinal products - PSUSA/00000776/201801","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2018-10-17T17:10:00Z","last_updated_date":"2018-10-17T17:10:00Z","reference_number":"EMA/684413/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciprofloxacin-topical-use-list-nationally-authorised-medicinal-products-psusa00000776201801_en.pdf"},
    {"id":"42359","name":"Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201803","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2018-10-17T17:15:00Z","last_updated_date":"2018-10-17T17:15:00Z","reference_number":"EMA/684895/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/olodaterol-list-nationally-authorised-medicinal-products-psusa00010245201803_en.pdf"},
    {"id":"42360","name":"CHMP summary of positive opinion for Takhzyro","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-10-19T12:00:00Z","last_updated_date":"2018-10-19T12:00:00Z","reference_number":"EMA/700432/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-takhzyro_en.pdf"},
    {"id":"42361","name":"Agenda - CAT agenda of the 10-12 October 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-10-18T10:00:00Z","last_updated_date":"2018-10-18T10:00:00Z","reference_number":"EMA/CAT/709578/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-10-12-october-2018-meeting_en.pdf"},
    {"id":"42362","name":"Agenda - CAT agenda of the 10-12 October 2018 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-10-18T10:00:00Z","last_updated_date":"2018-10-18T10:00:00Z","reference_number":"EMA/CAT/709578/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-10-12-october-2018-meeting_en.pdf-0"},
    {"id":"42364","name":"CHMP summary of positive opinion for Ogivri","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-10-19T12:00:00Z","last_updated_date":"2018-10-19T12:00:00Z","reference_number":"EMA/CHMP/688548/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ogivri_en.pdf"},
    {"id":"42365","name":"Outcome of written procedures during the period 22 May 2018 to 10 September 2018","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-10-18T14:56:00Z","last_updated_date":"2018-10-18T14:56:00Z","reference_number":"EMA/MB/540105/2018","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-written-procedures-during-period-22-may-2018-10-september-2018_en.pdf"},
    {"id":"42366","name":"Summary of transfers of appropriations in budget 2018 - Management Board meeting of 4 October 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-10-18T14:58:00Z","last_updated_date":"2018-10-18T14:58:00Z","reference_number":"EMA/MB/584626/2018","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2018-management-board-meeting-4-october-2018_en.pdf"},
    {"id":"42367","name":"Update on the pilot of signal detection in EudraVigilance by marketing authorisation holders","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-10-18T14:59:00Z","last_updated_date":"2018-10-18T14:59:00Z","reference_number":"EMA/MB/493254/2018","document_url":"https://www.ema.europa.eu/en/documents/other/update-pilot-signal-detection-eudravigilance-marketing-authorisation-holders_en.pdf"},
    {"id":"42369","name":"CHMP post-authorisation summary of positive opinion for NovoSeven","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-10-19T12:00:00Z","last_updated_date":"2018-10-19T12:00:00Z","reference_number":"EMA/CHMP/701490/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-novoseven_en.pdf"},
    {"id":"42372","name":"CHMP post-authorisation summary of positive opinion for Kalydeco (II-69)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-10-19T12:00:00Z","last_updated_date":"2018-10-19T12:00:00Z","reference_number":"EMA/CHMP/727925/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kalydeco-ii-69_en.pdf"},
    {"id":"42373","name":"New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T10:36:00Z","last_updated_date":"2018-10-19T10:36:00Z","reference_number":"EMA/CHMP/721397/2018 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-medicine-hereditary-angioedema-rare-disease-causing-swelling-beneath-skin_en.pdf"},
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    {"id":"42381","name":"CHMP statistics: October 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T13:45:00Z","last_updated_date":"2018-10-19T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/chmp-statistics-october-2018_en.pdf"},
    {"id":"42382","name":"Agenda – European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T15:10:00Z","last_updated_date":"2018-10-19T15:10:00Z","reference_number":"EMA/23322/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-union-eu-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf"},
    {"id":"42383","name":"Minutes - European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T15:20:00Z","last_updated_date":"2018-10-19T15:20:00Z","reference_number":"EMA/239218/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-eu-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf"},
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    {"id":"42385","name":"Presentation - Substance management system (SMS) / EU-SRS update (Frits Stulp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T15:31:00Z","last_updated_date":"2018-10-19T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-management-system-sms-eu-srs-update-frits-stulp_en.pdf"},
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    {"id":"42387","name":"First vaccine for prevention of dengue","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T15:38:00Z","last_updated_date":"2018-10-19T15:38:00Z","reference_number":"EMA/CHMP/717080/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-vaccine-prevention-dengue_en.pdf"},
    {"id":"42388","name":"Presentation - Product management system (PMS) workshop","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T15:38:00Z","last_updated_date":"2018-10-19T15:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-management-system-pms-workshop_en.pdf"},
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    {"id":"42390","name":"Presentation - Target operating model (part of the Product management system (PMS) data quality (Jeff Martin, Martha Schei Hynne) presentation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T16:10:00Z","last_updated_date":"2018-10-19T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-target-operating-model-part-product-management-system-pms-data-quality-jeff-martin-martha-schei-hynne-presentation_en.pdf"},
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    {"id":"42394","name":"Presentation - IRISS (Implementation of Regulatory Information Submission Standards) IDMP Topic Group (Frits Stulp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T16:16:00Z","last_updated_date":"2018-10-19T16:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-iriss-implementation-regulatory-information-submission-standards-idmp-topic-group-frits-stulp_en.pdf"},
    {"id":"42396","name":"Agenda - European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T16:30:00Z","last_updated_date":"2018-10-19T16:30:00Z","reference_number":"EMA/289228/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf-0"},
    {"id":"42397","name":"Minutes -  European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T16:41:00Z","last_updated_date":"2018-10-19T16:41:00Z","reference_number":"EMA/471122/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting_en.pdf-1"},
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    {"id":"42402","name":"Presentation - New veterinary regulation (NVR): impact on Information Technology / Telematics (Jos Olaerts, Jana Schalansky)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T16:51:00Z","last_updated_date":"2018-10-19T16:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-veterinary-regulation-nvr-impact-information-technology-telematics-jos-olaerts-jana-schalansky_en.pdf"},
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    {"id":"42404","name":"Presentation - Substance, Product, Organisation and Referential data (SPOR) -  Referentials Management Service (RMS) and Organisations Management Service (OMS) communication update","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T16:54:00Z","last_updated_date":"2018-10-19T16:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-product-organisation-and-referential-data-spor-referentials-management-service-rms-and-organisations-management-service-oms-communication-update_en.pdf"},
    {"id":"42412","name":"Agenda - Heads of Medicines Agencies / European Medicines Agency technical meeting on availability of authorised human medicines","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2018-10-22T17:18:00Z","last_updated_date":"2018-10-22T17:18:00Z","reference_number":"EMA/516015/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-heads-medicines-agencies-european-medicines-agency-technical-meeting-availability-authorised-human-medicines_en.pdf"},
    {"id":"42418","name":"Handling times for requests for EMA certificates through standard procedure","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-10-23T12:13:00Z","last_updated_date":"2021-05-05T17:00:00Z","reference_number":"EMA/579807/2018 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/handling-times-requests-ema-certificates-through-standard-procedure_en.pdf"},
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    {"id":"42568","name":"Guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-07T15:14:00Z","last_updated_date":"2018-11-07T15:14:00Z","reference_number":"EMA/CHMP/257022/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-medicinal-products-indicated-prophylaxis-or-treatment-respiratory-syncytial-virus-rsv-disease-first-version_en.pdf"},
    {"id":"42569","name":"Overview of comments received on 'Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease' (EMA/CHMP/257022/2017) - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-11-07T15:17:00Z","last_updated_date":"2018-11-07T15:17:00Z","reference_number":"EMA/746314/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-clinical-evaluation-medicinal-products-indicated-prophylaxis-or-treatment-respiratory-syncytial-virus-rsv-disease-emachmp2570222017-first-version_en.pdf"},
    {"id":"42570","name":"Reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - First","type":"scientific-guideline","status":"Draft","consultation_date":"","first_published_date":"2018-11-07T15:51:00Z","last_updated_date":"2018-11-07T15:51:00Z","reference_number":"EMA/CHMP/CVMP/3Rs/742466/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-providing-overview-current-regulatory-testing-requirements-medicinal-products-human-use-and-opportunities-implementation-3rs-first_en.pdf"},
    {"id":"42574","name":"Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-07T16:38:00Z","last_updated_date":"2019-04-29T09:58:00Z","reference_number":"CPMP/EWP/239/95 Rev. 1 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-equivalence-studies-demonstration-therapeutic-equivalence-locally-applied-locally-acting-products-gastrointestinal-tract-revision-1_en.pdf"},
    {"id":"42575","name":"Overview of comments received on 'Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract' (EMA/CPMP/EWP/239/95 Rev.1) - Revision 1","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-11-07T16:41:00Z","last_updated_date":"2018-11-07T16:41:00Z","reference_number":"EMA/CHMP/648051/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-equivalence-studies-demonstration-therapeutic-equivalence-locally-applied-locally-acting-products-gastrointestinal-tract-emacpmpewp23995-rev1-revision-1_en.pdf"},
    {"id":"42576","name":"Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials with tracked changes - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-07T17:00:00Z","last_updated_date":"2018-11-07T17:00:00Z","reference_number":"EMA/CHMP/BWP/534898/2008 rev. 1 corrigendum","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials-tracked-changes-revision-1_en.pdf"},
    {"id":"42577","name":"Guideline on quality aspects included in the product information for vaccines for human use - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-07T18:36:00Z","last_updated_date":"2018-11-07T18:36:00Z","reference_number":"EMA/CHMP/BWP/133540/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-aspects-included-product-information-vaccines-human-use-revision-1_en.pdf"},
    {"id":"42578","name":"Overview of comments received on 'Guideline on quality aspects included in the product information for vaccines for human use' (EMA/CHMP/BWP/133540/2017) - Revision 1","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-11-07T17:43:00Z","last_updated_date":"2018-11-07T17:43:00Z","reference_number":"EMA/CHMP/BWP/668918/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-quality-aspects-included-product-information-vaccines-human-use-emachmpbwp1335402017-revision-1_en.pdf"},
    {"id":"42579","name":"Pimecrolimus: List of nationally authorised medicinal products - PSUSA/00002411/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T10:39:00Z","last_updated_date":"2018-11-08T10:39:00Z","reference_number":"EMA/776462/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/pimecrolimus-list-nationally-authorised-medicinal-products-psusa00002411201803_en.pdf"},
    {"id":"42580","name":"Questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-08T11:22:00Z","last_updated_date":"2018-11-08T11:22:00Z","reference_number":"EMA/CHMP/BWP/426390/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-haemagglutination-inhibition-hi-test-qualification-influenza-vaccine-inactivated-seed-preparations-first-version_en.pdf"},
    {"id":"42581","name":"Overview of comments received on 'Questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations' (EMA/CHMP/BWP/426390/2017) - First version","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T11:27:00Z","last_updated_date":"2018-11-08T11:27:00Z","reference_number":"EMA/CHMP/BWP/652969/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-questions-and-answers-haemagglutination-inhibition-hi-test-qualification-influenza-vaccine-inactivated-seed-preparations-emachmpbwp4263902017-first-version_en.pdf"},
    {"id":"42582","name":"Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T11:28:00Z","last_updated_date":"2018-11-08T11:28:00Z","reference_number":"EMA/776464/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/cabergoline-list-nationally-authorised-medicinal-products-psusa00000477201803_en.pdf"},
    {"id":"42584","name":"Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-08T11:33:00Z","last_updated_date":"2018-11-08T11:33:00Z","reference_number":"EMA/CHMP/BWP/192228/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-bovine-spongiform-encephalopathies-bse-and-vaccines-revision-1_en.pdf"},
    {"id":"42586","name":"Overview of comments received on ‘Questions and Answers on bovine spongiform encephalopathies (BSE) and vaccines’ (EMA/CHMP/BWP/192228/2017) - Revision 1","type":"comments","status":"Adopted","consultation_date":"","first_published_date":"2018-11-08T12:00:00Z","last_updated_date":"2018-11-08T12:00:00Z","reference_number":"EMA/CHMP/BWP/637549/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-questions-and-answers-bovine-spongiform-encephalopathies-bse-and-vaccines-emachmpbwp1922282017-revision-1_en.pdf"},
    {"id":"42587","name":"List of participants - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:36:00Z","last_updated_date":"2018-11-08T15:36:00Z","reference_number":"EMA/780447/2018","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory-science-2025_en.pdf"},
    {"id":"42588","name":"Reference material - - Multistakeholder workshop to launch consultation on European Medicines Agency (EMA) human regulatory science to 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:39:00Z","last_updated_date":"2018-11-08T15:39:00Z","reference_number":"EMA/723198/2018","document_url":"https://www.ema.europa.eu/en/documents/other/reference-material-multistakeholder-workshop-launch-consultation-european-medicines-agency-ema-human-regulatory-science-2025_en.pdf"},
    {"id":"42589","name":"Presentation - Responding to the needs of the 21st century patient: Addressing challenges and opportunities across the European regulatory framework (Hans-Georg Eichler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:41:00Z","last_updated_date":"2018-11-08T15:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-responding-needs-21st-century-patient-addressing-challenges-and-opportunities-across-european-regulatory-framework-hans-georg-eichler_en.pdf"},
    {"id":"42590","name":"Presentation - European Organisation for Rare Diseases (EURORDIS): The point of view of patients (Simone Boselli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:43:00Z","last_updated_date":"2018-11-08T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-organisation-rare-diseases-eurordis-point-view-patients-simone-boselli_en.pdf"},
    {"id":"42591","name":"Presentation - Session 1.04 - Responding to the needs of the 21st century patient: Addressing challenges and opportunities across the European regulatory framework (Olga Solomon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:47:00Z","last_updated_date":"2018-11-08T15:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-104-responding-needs-21st-century-patient-addressing-challenges-and-opportunities-across-european-regulatory-framework-olga-solomon_en.pdf"},
    {"id":"42592","name":"Presentation - Session 1.05 - View from European Medicines Regulatory Network (Karl Broich)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:52:00Z","last_updated_date":"2018-11-08T15:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-105-view-european-medicines-regulatory-network-karl-broich_en.pdf"},
    {"id":"42593","name":"Presentation - Session 2 - Catalysing the integration of science and technology in drug development - EMA’s core recommendations (Enrica Alteri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:57:00Z","last_updated_date":"2018-11-08T15:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-catalysing-integration-science-and-technology-drug-development-emas-core-recommendations-enrica-alteri_en.pdf"},
    {"id":"42594","name":"Presentation - Session 3 - Driving collaborative evidence generation - Improving the scientific quality of evaluations - EMA’s core recommendations (Zaide Frias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T15:58:00Z","last_updated_date":"2018-11-08T15:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-driving-collaborative-evidence-generation-improving-scientific-quality-evaluations-emas-core-recommendations-zaide-frias_en.pdf"},
    {"id":"42595","name":"Presentation - Session 4 - Advancing patient-centred access to medicines in partnership with healthcare systems - EMA’s core recommendations (Michael Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:00:00Z","last_updated_date":"2018-11-08T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-advancing-patient-centred-access-medicines-partnership-healthcare-systems-emas-core-recommendations-michael-berntgen_en.pdf"},
    {"id":"42596","name":"Presentation -Session 5 - Addressing emerging health threats and availability/therapeutic challenges - EMA’s core recommendations (Marco Cavaleri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:03:00Z","last_updated_date":"2018-11-08T16:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-addressing-emerging-health-threats-and-availabilitytherapeutic-challenges-emas-core-recommendations-marco-cavaleri_en.pdf"},
    {"id":"42597","name":"Presentation - Session 6 - Enabling and leveraging research and innovation in regulatory science - EMA’s core recommendations (Alison Cave)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:07:00Z","last_updated_date":"2018-11-08T16:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-6-enabling-and-leveraging-research-and-innovation-regulatory-science-emas-core-recommendations-alison-cave_en.pdf"},
    {"id":"42598","name":"List of participants  - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:47:00Z","last_updated_date":"2018-11-08T16:47:00Z","reference_number":"EMA/373497/2018","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-ema-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp_en.pdf"},
    {"id":"42599","name":"Presentation - Patient engagement along the regulatory lifecycle (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:49:00Z","last_updated_date":"2018-11-08T16:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-engagement-along-regulatory-lifecycle-nathalie-bere_en.pdf"},
    {"id":"42600","name":"Presentation - Visibility of patient input throughout scientific procedures (Maria Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:50:00Z","last_updated_date":"2018-11-08T16:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-visibility-patient-input-throughout-scientific-procedures-maria-mavris_en.pdf"},
    {"id":"42601","name":"Presentation - Relaunch of EMA corporate website (Angela-Christina Schmidt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:52:00Z","last_updated_date":"2018-11-08T16:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-relaunch-ema-corporate-website-angela-christina-schmidt_en.pdf"},
    {"id":"42602","name":"Presentation - COMP feedback to EMA's Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) Article 8.2 et all (Daniel O’Connor)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:54:00Z","last_updated_date":"2018-11-08T16:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comp-feedback-emas-human-scientific-committees-working-parties-patients-and-consumers-organisations-pcwp-article-82-et-all-daniel-oconnor_en.pdf"},
    {"id":"42603","name":"Presentation - The Committee for Advanced Therapies (CAT) update (Kieran Breen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-08T16:57:00Z","last_updated_date":"2018-11-08T16:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-committee-advanced-therapies-cat-update-kieran-breen_en.pdf-1"},
    {"id":"42604","name":"Citrix user guide","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T11:20:00Z","last_updated_date":"2018-11-09T11:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/citrix-user-guide_en.pdf"},
    {"id":"42605","name":"Promestriene (cream and vaginal capsules): List of nationally authorised medicinal products - PSUSA/00009271/201803","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2018-11-09T11:51:00Z","last_updated_date":"2018-11-09T11:51:00Z","reference_number":"EMA/785057/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/promestriene-cream-and-vaginal-capsules-list-nationally-authorised-medicinal-products-psusa00009271201803_en.pdf"},
    {"id":"42606","name":"Dienogest / ethinylestradiol: List of nationall authorised medicinal products - PSUSA/00001057/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T11:52:00Z","last_updated_date":"2018-11-09T11:52:00Z","reference_number":"EMA/782577/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/dienogest-ethinylestradiol-list-nationall-authorised-medicinal-products-psusa00001057201803_en.pdf"},
    {"id":"42607","name":"Dobutamine: List of nationally authorised medicinal products - PSUSA/00001151/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T11:56:00Z","last_updated_date":"2018-11-09T11:56:00Z","reference_number":"EMA/783100/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/dobutamine-list-nationally-authorised-medicinal-products-psusa00001151201803_en.pdf"},
    {"id":"42608","name":"Citrulline malate: List of nationally authorised medicinal products - PSUSA/00010579/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T12:08:00Z","last_updated_date":"2018-11-09T12:08:00Z","reference_number":"EMA/784763/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/citrulline-malate-list-nationally-authorised-medicinal-products-psusa00010579201803_en.pdf"},
    {"id":"42609","name":"Influenza vaccine (surface antigen, inactivated, adjuvanted): List of nationally authorised medicinal products - PSUSA/00010300/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T12:18:00Z","last_updated_date":"2018-11-09T12:18:00Z","reference_number":"EMA/785153/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-adjuvanted-list-nationally-authorised-medicinal-products-psusa00010300201803_en.pdf"},
    {"id":"42610","name":"External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.4","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-11-09T12:54:00Z","last_updated_date":"2018-11-09T12:54:00Z","reference_number":"EMA/90915/2016 Version 1.4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use-version-14_en.pdf"},
    {"id":"42611","name":"Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.4","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2018-11-09T12:56:00Z","last_updated_date":"2018-11-09T12:56:00Z","reference_number":"EMA/482146/2018","document_url":"https://www.ema.europa.eu/en/documents/other/summary-changes-external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use-version-14_en.pdf"},
    {"id":"42612","name":"Human medicines highlights - November 2018","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T14:42:00Z","last_updated_date":"2018-11-22T12:00:00Z","reference_number":"Issue 116","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-november-2018_en.pdf"},
    {"id":"42615","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-8 November 2018","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T16:00:00Z","last_updated_date":"2018-11-09T16:00:00Z","reference_number":"EMA/CVMP/741346/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-6-8-november-2018_en.pdf"},
    {"id":"42616","name":"Report - First EMA workshop on non-animal approaches in support of medicinal product development – challenges and opportunities for use of micro-physiological systems","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T14:58:00Z","last_updated_date":"2018-11-09T14:58:00Z","reference_number":"EMA/CHMP/SWP/250438/2018","document_url":"https://www.ema.europa.eu/en/documents/report/report-first-ema-workshop-non-animal-approaches-support-medicinal-product-development-challenges-and-opportunities-use-micro-physiological-systems_en.pdf"},
    {"id":"42617","name":"CVMP summary of positive opinion for Isemid","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-11-09T15:35:00Z","last_updated_date":"2018-11-09T15:35:00Z","reference_number":"EMA/CVMP/719848/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-isemid_en.pdf"},
    {"id":"42618","name":"CVMP summary of opinion for Syvazul BTV","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-11-09T15:54:00Z","last_updated_date":"2018-11-09T15:54:00Z","reference_number":"EMA/CVMP/735427/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-opinion-syvazul-btv_en.pdf"},
    {"id":"42619","name":"CVMP post-authorisation summary of positive opinion for Aftovaxpur DOE","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-11-09T16:30:00Z","last_updated_date":"2018-11-09T16:30:00Z","reference_number":"EMA/CVMP/722013/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-aftovaxpur-doe_en.pdf-0"},
    {"id":"42621","name":"List of participants of the European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-11-09T18:00:00Z","last_updated_date":"2018-11-09T18:00:00Z","reference_number":"EMA/368105/2018","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-human-scientific-committees-working-party-healthcare-professionals-organisations-hcpwp-meeting_en.pdf-0"},
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    {"id":"42673","name":"CHMP summary of positive opinion for Silodosin Recordati","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-11-16T14:50:00Z","last_updated_date":"2018-11-16T14:50:00Z","reference_number":"EMA/766073/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-silodosin-recordati_en.pdf"},
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    {"id":"42683","name":"Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: overview (Johan Schefferlie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-15T12:33:00Z","last_updated_date":"2018-11-15T12:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-meeting-pilot-project-dose-optimisation-established-veterinary-antibiotics-context-spc-harmonisation-overview-johan-schefferlie_en.pdf"},
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    {"id":"42685","name":"Presentation - Pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: industry view (Elsa Vecino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-15T12:38:00Z","last_updated_date":"2018-11-15T12:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pilot-project-dose-optimisation-established-veterinary-antibiotics-context-spc-harmonisation-industry-view-elsa-vecino_en.pdf"},
    {"id":"42686","name":"Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: PK/PD approach for dose optimisation (Damien Bouchard, Pascal Sanders)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-15T12:41:00Z","last_updated_date":"2018-11-15T12:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-meeting-pilot-project-dose-optimisation-established-veterinary-antibiotics-context-spc-harmonisation-pkpd-approach-dose-optimisation-damien-bouchard-pascal-sanders_en.pdf"},
    {"id":"42687","name":"Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: target animal safety (Helen Jukes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-15T12:43:00Z","last_updated_date":"2018-11-15T12:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-meeting-pilot-project-dose-optimisation-established-veterinary-antibiotics-context-spc-harmonisation-target-animal-safety-helen-jukes_en.pdf"},
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    {"id":"42689","name":"Presentation - Focus group meeting the pilot project on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation: dose dependent withdrawal periods (Peter Hekman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-11-15T12:47:00Z","last_updated_date":"2018-11-15T12:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-meeting-pilot-project-dose-optimisation-established-veterinary-antibiotics-context-spc-harmonisation-dose-dependent-withdrawal-periods-peter-hekman_en.pdf"},
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    {"id":"42730","name":"Towards electronic product information for EU medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-11-21T12:57:00Z","last_updated_date":"2018-11-21T12:57:00Z","reference_number":"EMA/799809/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/towards-electronic-product-information-eu-medicines_en.pdf"},
    {"id":"42734","name":"Overview of comments received on 'Reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union' (EMA/CVMP/AWP/237294/2017) - First version","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2018-11-21T16:29:00Z","last_updated_date":"2018-11-21T16:29:00Z","reference_number":"EMA/CVMP/AWP/30098/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-reflection-paper-label-use-antimicrobials-veterinary-medicine-european-union-emacvmpawp2372942017-first-version_en.pdf"},
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    {"id":"42990","name":"Agenda and registration - ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Berlin","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-07-03T17:39:00Z","last_updated_date":"2019-07-03T17:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-isoich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-berlin_en.pdf"},
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    {"id":"42998","name":"Agenda and registration - ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Basel","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-07-03T19:08:00Z","last_updated_date":"2019-07-03T19:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-isoich-e2br3-individual-case-safety-reporting-eu-hands-training-course-using-eudravigilance-system-basel_en.pdf"},
    {"id":"43001","name":"Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus (AAV) vector encoding genes from an algae channel rhodopsin","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T11:30:00Z","last_updated_date":"2018-12-12T11:30:00Z","reference_number":"EMA/576002/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adeno-associated-virus-aav-vector-encoding-genes-algae-channel-rhodopsin_en.pdf"},
    {"id":"43002","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T11:17:00Z","last_updated_date":"2018-12-12T11:17:00Z","reference_number":"EMA/576036/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-ex-vivo-expanded-regulatory-t-lymphocytes-cell-marker-profile-cd3-cd4-cd25high-cd127-foxp3_en.pdf"},
    {"id":"43003","name":"Scientific recommendation on classification of advanced therapy medicinal products: Collagenase enzyme from Clostridium histolyticum","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T11:19:00Z","last_updated_date":"2018-12-12T11:19:00Z","reference_number":"EMA/576408/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-collagenase-enzyme-clostridium-histolyticum_en.pdf"},
    {"id":"43004","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T11:21:00Z","last_updated_date":"2018-12-12T11:21:00Z","reference_number":"EMA/576422/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-concentrated-bone-marrow_en.pdf"},
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    {"id":"43006","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T11:25:00Z","last_updated_date":"2018-12-12T11:25:00Z","reference_number":"EMA/576506/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-fibroblasts-expanded-vitro_en.pdf"},
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    {"id":"43015","name":"Public statement on Zoledronic acid Teva Pharma:  Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T15:36:00Z","last_updated_date":"2018-12-12T15:36:00Z","reference_number":"EMA/817045/2018","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zoledronic-acid-teva-pharma-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"43016","name":"Withdrawal letter: Fyzoclad","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-fyzoclad_en.pdf"},
    {"id":"43017","name":"Withdrawal assessment report for Entolimod TMC","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-12-12T16:18:00Z","last_updated_date":"2018-12-12T16:18:00Z","reference_number":"EMA/CHMP/781541/2018","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-entolimod-tmc_en.pdf"},
    {"id":"43018","name":"Withdrawal letter: Canakinumab Novartis","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-canakinumab-novartis_en.pdf"},
    {"id":"43023","name":"Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T17:47:00Z","last_updated_date":"2018-12-12T17:47:00Z","reference_number":"EMA/570147/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-homogenate-antlerogenic-stem-cells_en.pdf"},
    {"id":"43024","name":"Scientific recommendation on classification of advanced therapy medicinal products: Non-replicating recombinant adeno-associated virus carrying a fragment of the Channelrhodopsin-2 (ChR2) protein","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T17:49:00Z","last_updated_date":"2018-12-12T17:49:00Z","reference_number":"EMA/608844/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-non-replicating-recombinant-adeno-associated-virus-carrying-fragment-channelrhodopsin-2-chr2-protein_en.pdf"},
    {"id":"43025","name":"Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T17:51:00Z","last_updated_date":"2018-12-12T17:51:00Z","reference_number":"EMA/570248/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-homogenate-antlerogenic-stem-cells_en.pdf-0"},
    {"id":"43026","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T17:52:00Z","last_updated_date":"2018-12-12T17:52:00Z","reference_number":"EMA/570349/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-anti-bcma-b-cell-maturation-antigen-chimeric-antigen-receptor-car-t-cells_en.pdf"},
    {"id":"43027","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-12-12T17:54:00Z","last_updated_date":"2018-12-12T17:54:00Z","reference_number":"EMA/608871/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-suspension-blood-derived-endothelial-and-hematopoietic-stemprogenitor-cells_en.pdf"},
    {"id":"43028","name":"Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of defective myoblasts from a Duchenne Muscular Dystrophy patient with normal myoblasts","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T17:55:00Z","last_updated_date":"2018-12-12T17:55:00Z","reference_number":"EMA/570419/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-dystrophin-expressing-chimeric-cells-obtained-ex-vivo-fusion-defective-myoblasts-duchenne-muscular-dystrophy-patient-normal_en.pdf"},
    {"id":"43029","name":"Scientific recommendation on classification of advanced therapy medicinal products: Four in vitro transcribed mRNA molecules each encoding one tumour antigen","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-12-12T17:57:00Z","last_updated_date":"2018-12-12T17:57:00Z","reference_number":"EMA/608907/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-four-vitro-transcribed-mrna-molecules-each-encoding-one-tumour-antigen_en.pdf"},
    {"id":"43030","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed patient-specific mRNA molecule encoding neo-epitopes that are specifically derived from tumour tissue","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-12-12T18:09:00Z","last_updated_date":"2018-12-12T18:09:00Z","reference_number":"EMA/608944/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-transcribed-patient-specific-mrna-molecule-encoding-neo-epitopes-are-specifically-derived-tumour-tissue_en.pdf"},
    {"id":"43031","name":"Scientific recommendation on classification of advanced therapy medicinal products: Dystrophin expressing chimeric cells obtained by ex vivo fusion of two normal allogeneic human myoblasts","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T18:16:00Z","last_updated_date":"2018-12-12T18:16:00Z","reference_number":"EMA/570450/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-dystrophin-expressing-chimeric-cells-obtained-ex-vivo-fusion-two-normal-allogeneic-human-myoblasts_en.pdf"},
    {"id":"43032","name":"Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T18:17:00Z","last_updated_date":"2018-12-12T18:17:00Z","reference_number":"EMA/570532/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-codon-optimized-human-ornithine-transcarbamylase-messenger-ribonucleic-acid_en.pdf"},
    {"id":"43033","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector capsid containing the human iduronate-2-sulfatase (hIDS) expression cassette","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T18:19:00Z","last_updated_date":"2018-12-12T18:19:00Z","reference_number":"EMA/570585/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-viral-vector-capsid-containing-human-iduronate-2-sulfatase-hids-expression-cassette_en.pdf"},
    {"id":"43034","name":"Scientific recommendation on classification of advanced therapy medicinal products: Homogenate of antlerogenic stem cells - Tissue engineered product","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-12T18:50:00Z","last_updated_date":"2018-12-12T18:50:00Z","reference_number":"EMA/570248/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-homogenate-antlerogenic-stem-cells-tissue-engineered-product_en.pdf"},
    {"id":"43036","name":"Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-12-13T12:36:00Z","last_updated_date":"2018-12-13T12:36:00Z","reference_number":"EMA/CHMP/458101/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-and-simulation_en.pdf"},
    {"id":"43037","name":"CHMP summary of positive opinion for Rizmoic","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/845509/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rizmoic_en.pdf"},
    {"id":"43038","name":"CHMP post-authorisation summary of positive opinion for Trimbow (II-02)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/598794/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trimbow-ii-02_en.pdf"},
    {"id":"43039","name":"CHMP post-authorisation summary of positive opinion for Sprycel (II-59)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T15:46:00Z","last_updated_date":"2018-12-14T15:46:00Z","reference_number":"EMA/CHMP/840868/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sprycel-ii-59_en.pdf"},
    {"id":"43040","name":"CHMP post-authorisation summary of positive opinion for Simponi (X-83-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T16:50:00Z","last_updated_date":"2018-12-14T16:50:00Z","reference_number":"EMA/CHMP/833171/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-simponi-x-83-g_en.pdf"},
    {"id":"43041","name":"Start of community reviews - CHMP meeting of 10-13 December 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/855943/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-community-reviews-chmp-meeting-10-13-december-2018_en.pdf"},
    {"id":"43042","name":"Metamizole Article-31 referral - EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T17:03:00Z","last_updated_date":"2019-04-15T19:20:00Z","reference_number":"EMA/191666/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metamizole-article-31-referral-ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_sv.pdf"}},
    {"id":"43043","name":"Metamizole Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T17:05:00Z","last_updated_date":"2019-03-28T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metamizole-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metamizole-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metamizole-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metamizole-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metamizole-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metamizole-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metamizole-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metamizole-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metamizole-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metamizole-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metamizole-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metamizole-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metamizole-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metamizole-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metamizole-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metamizole-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metamizole-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metamizole-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metamizole-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metamizole-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metamizole-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metamizole-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"43044","name":"CHMP summary of positive opinion for Tobramycin PARI","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/CHMP/862388/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tobramycin-pari_en.pdf"},
    {"id":"43045","name":"CHMP summary of positive opinion for Miglustat Dipharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/CHMP/825267/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-miglustat-dipharma_en.pdf"},
    {"id":"43046","name":"CHMP post-authorisation summary of positive opinion for Rapiscan (II-27)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/CHMP/831008/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rapiscan-ii-27_en.pdf"},
    {"id":"43047","name":"Omega-3 acid ethyl esters - EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart 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    {"id":"43048","name":"Omega-3 fatty acid medicines no longer considered effective in preventing heart disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T18:00:00Z","last_updated_date":"2018-12-14T18:00:00Z","reference_number":"EMA/712678/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/omega-3-fatty-acid-medicines-no-longer-considered-effective-preventing-heart-disease_en.pdf"},
    {"id":"43049","name":"EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T18:04:00Z","last_updated_date":"2018-12-14T18:04:00Z","reference_number":"EMA/853069/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-aligning-doses-metamizole-medicines-and-their-use-during-pregnancy-and-breastfeeding_en.pdf"},
    {"id":"43050","name":"CHMP summary of positive opinion for Lusutrombopag Shionogi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/CHMP/862586/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lusutrombopag-shionogi_en.pdf"},
    {"id":"43051","name":"Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-12-13T18:57:00Z","last_updated_date":"2018-12-13T18:57:00Z","reference_number":"EMA/CHMP/291450/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/aliskiren-film-coated-tablet-150-mg-and-300-mg-product-specific-bioequivalence-guidance_en.pdf"},
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    {"id":"43053","name":"Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-12-13T19:17:00Z","last_updated_date":"2018-12-13T19:17:00Z","reference_number":"EMA/CHMP/800775/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/pegylated-liposomal-doxorubicin-hydrochloride-concentrate-solution-2-mgml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"43054","name":"Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-12-13T19:19:00Z","last_updated_date":"2018-12-13T19:19:00Z","reference_number":"EMA/CHMP/681372/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-pegylated-liposomal-doxorubicin-hydrochloride-concentrate-solution-2-mgml-product-specific-bioequivalence-guidance-emachmp8007752017_en.pdf"},
    {"id":"43055","name":"Questions and answers on the withdrawal of the marketing authorisation application for Fyzoclad (adalimumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2019-01-15T16:54:00Z","reference_number":"EMA/866697/2018","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-fyzoclad-adalimumab_sv.pdf"}},
    {"id":"43056","name":"CHMP post-authorisation summary of positive opinion for Rubraca (II-01)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/CHMP/830894/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rubraca-ii-01_en.pdf"},
    {"id":"43057","name":"Report on the EMA Management Board delegation visit to the future EMA premises","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T11:58:00Z","last_updated_date":"2018-12-14T11:58:00Z","reference_number":"EMA/8050171/2018","document_url":"https://www.ema.europa.eu/en/documents/report/report-ema-management-board-delegation-visit-future-ema-premises_en.pdf"},
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    {"id":"43063","name":"Questions and answers on the withdrawal of the marketing authorisation application for Canakinumab Novartis (canakinumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T12:00:00Z","last_updated_date":"2018-12-14T12:00:00Z","reference_number":"EMA/865778/2018","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-canakinumab-novartis-canakinumab_sv.pdf"}},
    {"id":"43064","name":"EMA Management Board: highlights of December 2018 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T11:09:00Z","last_updated_date":"2018-12-14T11:09:00Z","reference_number":"EMA/873779/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-december-2018-meeting_en.pdf"},
    {"id":"43066","name":"Omega-3 acid ethyl esters - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T11:32:00Z","last_updated_date":"2019-06-13T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/omega-3-acid-ethyl-esters-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/omega-3-acid-ethyl-esters-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/omega-3-acid-ethyl-esters-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/omega-3-acid-ethyl-esters-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/omega-3-acid-ethyl-esters-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/omega-3-acid-ethyl-esters-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/omega-3-acid-ethyl-esters-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/omega-3-acid-ethyl-esters-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/omega-3-acid-ethyl-esters-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/omega-3-acid-ethyl-esters-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/omega-3-acid-ethyl-esters-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/omega-3-acid-ethyl-esters-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/omega-3-acid-ethyl-esters-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/omega-3-acid-ethyl-esters-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/omega-3-acid-ethyl-esters-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/omega-3-acid-ethyl-esters-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/omega-3-acid-ethyl-esters-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/omega-3-acid-ethyl-esters-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/omega-3-acid-ethyl-esters-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/omega-3-acid-ethyl-esters-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/omega-3-acid-ethyl-esters-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/omega-3-acid-ethyl-esters-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/omega-3-acid-ethyl-esters-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/omega-3-acid-ethyl-esters-annex-iii_no.pdf"}},
    {"id":"43067","name":"CHMP summary of positive opinion for Zirabev","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T11:53:00Z","last_updated_date":"2018-12-14T11:53:00Z","reference_number":"EMA/CHMP/852740/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zirabev_en.pdf"},
    {"id":"43068","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T11:10:00Z","last_updated_date":"2018-12-14T11:10:00Z","reference_number":"EMA/818520/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-november-2018_en.pdf"},
    {"id":"43070","name":"CHMP summary of positive opinion for Besremi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T12:06:00Z","last_updated_date":"2018-12-14T12:06:00Z","reference_number":"EMA/CHMP/867687/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-besremi_en.pdf"},
    {"id":"43071","name":"Omega-3 acid ethyl esters - Start of referral","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-03-23T13:32:00Z","last_updated_date":"2018-03-23T13:32:00Z","reference_number":"EMA/177123/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/omega-3-acid-ethyl-esters-start-referral_en.pdf"},
    {"id":"43072","name":"Metamizole Article-31 referral - Start of referral","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-06-01T13:40:00Z","last_updated_date":"2018-06-01T13:40:00Z","reference_number":"EMA/338589/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-start-referral_en.pdf"},
    {"id":"43073","name":"CHMP post-authorisation summary of positive opinion for Adcetris (II-55)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T14:49:00Z","last_updated_date":"2018-12-14T14:49:00Z","reference_number":"EMA/CHMP/621289/2018","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adcetris-ii-55_en.pdf"},
    {"id":"43074","name":"CHMP summary of positive opinion for Trecondi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T14:00:00Z","last_updated_date":"2019-01-17T16:56:00Z","reference_number":"EMA/CHMP/848829/2018 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trecondi_en.pdf"},
    {"id":"43076","name":"Presentation - Session 1: Patient perspective (Robert Mitchell-Thain)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:06:00Z","last_updated_date":"2018-12-14T16:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-patient-perspective-robert-mitchell-thain_en.pdf"},
    {"id":"43077","name":"Presentation - Session 1: Authorisation of Ocaliva for PBC in the EU (J. Musaus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:08:00Z","last_updated_date":"2018-12-14T16:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-authorisation-ocaliva-pbc-eu-j-musaus_en.pdf"},
    {"id":"43078","name":"Presentation - Session 1: PBC: Definition, natural history and current therapeutic interventions (Gideon Hirschfield)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:10:00Z","last_updated_date":"2018-12-14T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-pbc-definition-natural-history-and-current-therapeutic-interventions-gideon-hirschfield_en.pdf"},
    {"id":"43079","name":"Presentation - Session 1: Historical outcome parameters used in PBC and the search for potential alternatives (Bettina E Hansen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:13:00Z","last_updated_date":"2018-12-14T16:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-historical-outcome-parameters-used-pbc-and-search-potential-alternatives-bettina-e-hansen_en.pdf"},
    {"id":"43080","name":"Presentation - Session 1: Potential trial designs and suitable study populations (Bettina E Hansen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:14:00Z","last_updated_date":"2018-12-14T16:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-potential-trial-designs-and-suitable-study-populations-bettina-e-hansen_en.pdf"},
    {"id":"43081","name":"Presentation - Session 2: EMA stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (Martine Walmsley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:17:00Z","last_updated_date":"2018-12-14T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-ema-stakeholder-interaction-development-medicinal-products-chronic-non-infectious-liver-diseases-martine-walmsley_en.pdf"},
    {"id":"43082","name":"Presentation - Session 2: Definition, natural history and the lack of approved therapeutic interventions (Douglas Thorburn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:19:00Z","last_updated_date":"2018-12-14T16:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-definition-natural-history-and-lack-approved-therapeutic-interventions-douglas-thorburn_en.pdf"},
    {"id":"43083","name":"Presentation - Session 2: Currently proposed endpoints in PSC: the search for reliable surrogate outcome parameters (Cyriel Ponsioen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:20:00Z","last_updated_date":"2018-12-14T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-currently-proposed-endpoints-psc-search-reliable-surrogate-outcome-parameters-cyriel-ponsioen_en.pdf"},
    {"id":"43084","name":"Presentation - Session 2: Potential trial design and suitable study populations (Michael Trauner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:22:00Z","last_updated_date":"2018-12-14T16:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-potential-trial-design-and-suitable-study-populations-michael-trauner_en.pdf"},
    {"id":"43085","name":"Presentation - Session 2: The need for paediatric developments in PSC, trial duration and endpoints (Henkjan J. Verkade)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:23:00Z","last_updated_date":"2018-12-14T16:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-need-paediatric-developments-psc-trial-duration-and-endpoints-henkjan-j-verkade_en.pdf"},
    {"id":"43086","name":"Presentation - Session 3: NASH - The patient perspective (Yvonne Gray)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:26:00Z","last_updated_date":"2018-12-14T16:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-nash-patient-perspective-yvonne-gray_en.pdf"},
    {"id":"43087","name":"Presentation - Session 3: PDCO current approach (Chrissi Pallidis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:27:00Z","last_updated_date":"2018-12-14T16:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-pdco-current-approach-chrissi-pallidis_en.pdf"},
    {"id":"43088","name":"Presentation - Session 3: Non-alcoholic steatohepatitis (NASH): Definition, natural history and current therapeutic interventions (Frank Tacke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:29:00Z","last_updated_date":"2018-12-14T16:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-non-alcoholic-steatohepatitis-nash-definition-natural-history-and-current-therapeutic-interventions-frank-tacke_en.pdf"},
    {"id":"43089","name":"Presentation - Session 3: Outcome in NASH trials: From histology and “hard outcomes” to less invasive reliable surrogates (Laurent Castera)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:31:00Z","last_updated_date":"2018-12-14T16:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-outcome-nash-trials-histology-and-hard-outcomes-less-invasive-reliable-surrogates-laurent-castera_en.pdf"},
    {"id":"43090","name":"Presentation - Session 3: Potential trial designs and suitable study populations (Quentin M. Anstee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:33:00Z","last_updated_date":"2018-12-14T16:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-potential-trial-designs-and-suitable-study-populations-quentin-m-anstee_en.pdf"},
    {"id":"43091","name":"Presentation - Session 3: NAFLD: Population in need, clinical trial duration and endpoints (Piotr Socha)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:35:00Z","last_updated_date":"2018-12-14T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-nafld-population-need-clinical-trial-duration-and-endpoints-piotr-socha_en.pdf"},
    {"id":"43092","name":"Final Guideline on Active Substance Master File Procedure - Revision 4","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T16:44:00Z","last_updated_date":"2018-12-14T16:44:00Z","reference_number":"CHMP/QWP/227/02 Rev 4, EMEA/CVMP/134/02 Rev 4 Corr.","document_url":"https://www.ema.europa.eu/en/documents/report/final-guideline-active-substance-master-file-procedure-revision-4_en.pdf"},
    {"id":"43093","name":"EudraVigilance access policy for medicines for veterinary use - Revision 1","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-12-14T15:45:00Z","last_updated_date":"2018-12-14T15:45:00Z","reference_number":"EMA/113700/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eudravigilance-access-policy-medicines-veterinary-use-revision-1_en.pdf"},
    {"id":"43094","name":"Financial compensation and workload estimation of the EMA organisation of translations of product related information","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:07:00Z","last_updated_date":"2018-12-14T16:07:00Z","reference_number":"EMA/MB/781386/2018","document_url":"https://www.ema.europa.eu/en/documents/other/financial-compensation-and-workload-estimation-ema-organisation-translations-product-related-information_en.pdf"},
    {"id":"43095","name":"Outcome of written procedures during the period 11 September 2018 to 23 November 2018","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:18:00Z","last_updated_date":"2018-12-14T16:18:00Z","reference_number":"EMA/MB/810142/2018","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-written-procedures-during-period-11-september-2018-23-november-2018_en.pdf"},
    {"id":"43096","name":"Summary of transfers of appropriations in budget 2018 - Management Board meeting of 12-13 December 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-14T16:26:00Z","last_updated_date":"2018-12-14T16:26:00Z","reference_number":"EMA/MB/832177/2018","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2018-management-board-meeting-12-13-december-2018_en.pdf"},
    {"id":"43100","name":"Overview of comments on 'Draft guideline on clinical development of fixed combination medicinal products - Revision 2 (EMA/CHMP/281825/2015)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-12-17T12:46:00Z","last_updated_date":"2018-12-17T12:46:00Z","reference_number":"EMA/757184/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-draft-guideline-clinical-development-fixed-combination-medicinal-products-revision-2-emachmp2818252015_en.pdf"},
    {"id":"43101","name":"Health threat plan map - Annex to EMA plan for emerging health threats","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-12-17T14:25:00Z","last_updated_date":"2018-12-17T14:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/health-threat-plan-map-annex-ema-plan-emerging-health-threats_en.pdf"},
    {"id":"43108","name":"COMP meeting report on the review of applications for orphan designation: December 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-12-17T17:27:00Z","last_updated_date":"2019-02-14T10:41:00Z","reference_number":"EMA/COMP/762677/2018 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-december-2018_en.pdf"},
    {"id":"43113","name":"Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-12-18T10:23:00Z","last_updated_date":"2018-12-18T10:23:00Z","reference_number":"EMA/INS/GCP/856758/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-content-management-and-archiving-clinical-trial-master-file-paper-andor-electronic_en.pdf"},
    {"id":"43114","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-07-03T11:02:00Z","last_updated_date":"2019-07-03T11:02:00Z","reference_number":"Course # 19582","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-amsterdam_en.pdf"},
    {"id":"43115","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Lisbon)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-07-03T10:15:00Z","last_updated_date":"2019-07-03T10:15:00Z","reference_number":"Course # 19584","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-lisbon_en.pdf"},
    {"id":"43121","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (London)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-07-03T10:20:00Z","last_updated_date":"2019-07-03T10:20:00Z","reference_number":"Course # 19583","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-face-face-training-course-london_en.pdf-0"},
    {"id":"43122","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T14:50:00Z","last_updated_date":"2018-12-18T14:50:00Z","reference_number":"EMA/574929/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogenic-bone-marrow-derived-mesenchymal-stem-cells-expanded-vitro_en.pdf"},
    {"id":"43123","name":"Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T15:01:00Z","last_updated_date":"2018-12-18T15:01:00Z","reference_number":"EMA/575002/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-concentrate-autologous-bone-marrow-derived-mononuclear-cells-bm-mnc_en.pdf-0"},
    {"id":"43124","name":"Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T15:11:00Z","last_updated_date":"2018-12-18T15:11:00Z","reference_number":"EMA/575038/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-live-attenuated-double-deleted-listeria-monocytogenes-expressing-human-mesothelin_en.pdf"},
    {"id":"43126","name":"Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T15:19:00Z","last_updated_date":"2018-12-18T15:19:00Z","reference_number":"EMA/575136/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-live-attenuated-double-deleted-listeria-monocytogenes-expressing-prostate-antigens_en.pdf"},
    {"id":"43127","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T15:25:00Z","last_updated_date":"2018-12-18T15:25:00Z","reference_number":"EMA/575213/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cultured-fibroblasts_en.pdf"},
    {"id":"43128","name":"Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T15:35:00Z","last_updated_date":"2018-12-18T15:35:00Z","reference_number":"EMA/575232/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-extracellular-matrix-isolated-adipose-tissue_en.pdf"},
    {"id":"43129","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T15:56:00Z","last_updated_date":"2018-12-18T15:56:00Z","reference_number":"EMA/575260/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cultured-adipose-derived-mesenchymal-stem-cells_en.pdf"},
    {"id":"43135","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T16:08:00Z","last_updated_date":"2018-12-18T16:08:00Z","reference_number":"EMA/575295/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-cultured-autologous-chondrocytes_en.pdf"},
    {"id":"43136","name":"Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T16:13:00Z","last_updated_date":"2018-12-18T16:13:00Z","reference_number":"EMA/575365/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-viable-human-autologous-skin-fibroblasts_en.pdf"},
    {"id":"43137","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T16:40:00Z","last_updated_date":"2018-12-18T16:40:00Z","reference_number":"EMA/575478/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-autologous-keratinocytes_en.pdf-0"},
    {"id":"43138","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T16:45:00Z","last_updated_date":"2018-12-18T16:45:00Z","reference_number":"EMA/575590/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-cultured-autologous-muscle-derived-stem-cells_en.pdf"},
    {"id":"43139","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T16:49:00Z","last_updated_date":"2018-12-18T16:49:00Z","reference_number":"EMA/575769/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-cultured-autologous-melanocytes_en.pdf"},
    {"id":"43140","name":"Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow","type":"report","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T16:54:00Z","last_updated_date":"2018-12-18T16:54:00Z","reference_number":"EMA/575867/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-mesenchymal-stem-cells-isolated-autologous-bone-marrow_en.pdf"},
    {"id":"43142","name":"Questions and answers on quality of herbal medicinal products/traditional herbal medicinal products - Revision 6","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T17:09:00Z","last_updated_date":"2018-12-18T17:09:00Z","reference_number":"EMA/HMPC/41500/2010 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-quality-herbal-medicinal-productstraditional-herbal-medicinal-products-revision-6_en.pdf"},
    {"id":"43143","name":"Committee for Advanced Therapies (CAT): work plan 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T16:31:00Z","last_updated_date":"2023-03-08T16:31:00Z","reference_number":"EMA/CAT/910738/2022","document_url":"https://www.ema.europa.eu/en/documents/other/committee-advanced-therapies-cat-work-plan-2023_en.pdf"},
    {"id":"43149","name":"Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-12-18T18:38:00Z","last_updated_date":"2018-12-18T18:38:00Z","reference_number":"EMA/874826/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-chloride-glutamic-acid-glutathione-histidine-lactobionic-acid-magnesium-chloride-mannitol-potassium-chloride-sodium-hydroxide-list-nationally-authorised-medicinal-products-psusa00010390201801_en.pdf"},
    {"id":"43154","name":"Regulatory Science to 2025 – launch of six-month public consultation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T11:20:00Z","last_updated_date":"2018-12-19T11:20:00Z","reference_number":"EMA/856924/2018","document_url":"https://www.ema.europa.eu/en/documents/press-release/regulatory-science-2025-launch-six-month-public-consultation_en.pdf"},
    {"id":"43155","name":"EU/3/18/2077: Public summary of opinion on orphan designation: Melatonin for the treatment of acute radiation syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T13:32:00Z","last_updated_date":"2018-12-19T13:32:00Z","reference_number":"EMA/678539/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182077-public-summary-opinion-orphan-designation-melatonin-treatment-acute-radiation-syndrome_en.pdf"},
    {"id":"43158","name":"EU/3/18/2066: Public summary of opinion on orphan designation: Pemigatinib for the treatment of biliary tract cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T13:55:00Z","last_updated_date":"2018-12-19T13:55:00Z","reference_number":"EMA/532482/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182066-public-summary-opinion-orphan-designation-pemigatinib-treatment-biliary-tract-cancer_en.pdf"},
    {"id":"43159","name":"EU/3/18/2069: Public summary of opinion on orphan designation: Tilorone for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T14:10:00Z","last_updated_date":"2018-12-19T14:10:00Z","reference_number":"EMA/521619/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182069-public-summary-opinion-orphan-designation-tilorone-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"43160","name":"EU/3/18/2068: Public summary of opinion on orphan designation: Somapacitan for the treatment of growth hormone deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T14:30:00Z","last_updated_date":"2018-12-19T14:30:00Z","reference_number":"EMA/534113/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182068-public-summary-opinion-orphan-designation-somapacitan-treatment-growth-hormone-deficiency_en.pdf"},
    {"id":"43162","name":"EU/3/18/2067: Public summary of opinion on orphan designation: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1 for the treatment of ectonucleotide pyrophosphatase/phosphodiesterase 1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T15:29:00Z","last_updated_date":"2018-12-19T15:29:00Z","reference_number":"EMA/534117/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182067-public-summary-opinion-orphan-designation-recombinant-human-ectonucleotide-pyrophosphatasephosphodiesterase-1-fused-fc-fragment-igg1-treatment-ectonucleotide-pyrophosphatasephosphodiesterase_en.pdf"},
    {"id":"43163","name":"EU/3/18/2061: Public summary of opinion on orphan designation: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T16:44:00Z","last_updated_date":"2018-12-19T16:44:00Z","reference_number":"EMA/514590/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182061-public-summary-opinion-orphan-designation-autologous-glioma-tumour-cells-treated-antisense-molecule-directed-against-insulin-growth-factor-type-1-receptor-treatment-glioma_en.pdf"},
    {"id":"43164","name":"EU/3/18/2057: Public summary of opinion on orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt for the treatment of acute myeloid le","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T16:51:00Z","last_updated_date":"2022-11-22T15:35:00Z","reference_number":"EMA/521611/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182057-public-summary-opinion-orphan-designation-1-2-hydroxyethyl-8-5-4-methylpiperazin-1-yl-2-trifluoromethoxy-phenylamino-45-dihydro-1h-pyrazolo43-hquinazoline-3-carboxamide-fumarate-salt_en.pdf"},
    {"id":"43165","name":"Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T16:00:00Z","last_updated_date":"2020-01-24T15:43:00Z","reference_number":"EMA/CVMP/016/2000 Rev. 3 corr. ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-3_en.pdf"},
    {"id":"43166","name":"EU/3/18/2055: Public summary of opinion on orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T17:12:00Z","last_updated_date":"2018-12-19T17:12:00Z","reference_number":"EMA/514601/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182055-public-summary-opinion-orphan-designation-3r3as9r9as9bs-3-dimethylaminomethyl-9-hydroxy-69-dimethyl-33a457899a-octahydroazuleno45-bfuran-29bh-one-fumarate-treatment-glioma_en.pdf"},
    {"id":"43167","name":"EU/3/18/2060: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene for the treatment of spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T17:20:00Z","last_updated_date":"2021-01-07T09:40:00Z","reference_number":"EMA/530909/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182060-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-hu68-containing-human-smn1-gene-treatment-spinal-muscular-atrophy_en.pdf"},
    {"id":"43168","name":"Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T17:21:00Z","last_updated_date":"2018-12-19T17:21:00Z","reference_number":"EMA/880324/2018","document_url":"https://www.ema.europa.eu/en/documents/psusa/enalapril-list-nationally-authorised-medicinal-products-psusa00001211201803_en.pdf"},
    {"id":"43169","name":"Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T16:30:00Z","last_updated_date":"2018-12-19T16:30:00Z","reference_number":"EMA/CVMP/755602/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-emacvmp01600-rev3-revision-3_en.pdf"},
    {"id":"43170","name":"EU/3/18/2064: Public summary of opinion on orphan designation: Copanlisib for the treatment of marginal zone lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T17:32:00Z","last_updated_date":"2018-12-19T17:32:00Z","reference_number":"EMA/533263/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182064-public-summary-opinion-orphan-designation-copanlisib-treatment-marginal-zone-lymphoma_en.pdf"},
    {"id":"43173","name":"EU/3/18/2065: Public summary of opinion on orphan designation: Obiltoxaximab for the treatment of anthrax","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-19T17:47:00Z","last_updated_date":"2018-12-19T17:47:00Z","reference_number":"EMA/532463/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182065-public-summary-opinion-orphan-designation-obiltoxaximab-treatment-anthrax_en.pdf"},
    {"id":"43174","name":"List of participants - European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:20:00Z","last_updated_date":"2018-12-19T18:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-ema-heads-medicines-agencies-hma-european-commission-ec-workshop-electronic-product-information-epi_en.pdf"},
    {"id":"43175","name":"Presentation - Towards digital transformation of health and care (K. Kurgonaite and P. Tosetti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:21:00Z","last_updated_date":"2018-12-19T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-towards-digital-transformation-health-and-care-k-kurgonaite-and-p-tosetti_en.pdf"},
    {"id":"43176","name":"Presentation - ePI: Getting the focus right (F. Tabatabaei)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:23:00Z","last_updated_date":"2018-12-19T18:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-epi-getting-focus-right-f-tabatabaei_en.pdf"},
    {"id":"43177","name":"Presentation - Opportunities for expanding access to produce information for medicines: a patient perspective (K. Immonen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:25:00Z","last_updated_date":"2018-12-19T18:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-expanding-access-produce-information-medicines-patient-perspective-k-immonen_en.pdf"},
    {"id":"43178","name":"Presentation - Workshop on electronic product information (S. Jensen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:27:00Z","last_updated_date":"2018-12-19T18:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-electronic-product-information-s-jensen_en.pdf"},
    {"id":"43179","name":"Presentation - Opportunities for expanding access to product information for medicines: Stakeholders’ needs and challenges’ from a perspective of a healthcare professional (D. J O'Loughlin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:29:00Z","last_updated_date":"2018-12-19T18:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-expanding-access-product-information-medicines-stakeholders-needs-and-challenges-perspective-healthcare-professional-d-j-oloughlin_en.pdf"},
    {"id":"43180","name":"Presentation - Electronic dissemination of product information (G. Bejeuhr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:35:00Z","last_updated_date":"2018-12-19T18:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronic-dissemination-product-information-g-bejeuhr_en.pdf"},
    {"id":"43181","name":"Presentation - Current landscape - How does ePI fit in with other initiatives? (M. Diaz and J. Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:37:00Z","last_updated_date":"2018-12-19T18:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-landscape-how-does-epi-fit-other-initiatives-m-diaz-and-j-burgos_en.pdf"},
    {"id":"43182","name":"Presentation - Overview of initiatives from the EMA-HMA mapping (R. Gonzalez-Quevedo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:39:00Z","last_updated_date":"2018-12-19T18:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-initiatives-ema-hma-mapping-r-gonzalez-quevedo_en.pdf"},
    {"id":"43183","name":"Presentation - Current landscape: How does ePI fit in with other initiatives - AEMPS (C. Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:42:00Z","last_updated_date":"2018-12-19T18:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-landscape-how-does-epi-fit-other-initiatives-aemps-c-garcia_en.pdf"},
    {"id":"43184","name":"Presentation - Collaboration with the Norwegian Pharmaceutical Compendium (V. Abyholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:45:00Z","last_updated_date":"2018-12-19T18:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-collaboration-norwegian-pharmaceutical-compendium-v-abyholm_en.pdf"},
    {"id":"43185","name":"Presentation - Electronically structured coded PI Swedish (human and veterinary) (K. Sherwood)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T18:46:00Z","last_updated_date":"2018-12-19T18:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronically-structured-coded-pi-swedish-human-and-veterinary-k-sherwood_en.pdf"},
    {"id":"43186","name":"EU/3/18/2063: Public summary of opinion on orphan designation: CD34+ haematopoietic stem and progenitor cells with CD3+ T-cells for treatment in solid organ transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-20T10:09:00Z","last_updated_date":"2018-12-20T10:09:00Z","reference_number":"EMA/533264/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182063-public-summary-opinion-orphan-designation-cd34-haematopoietic-stem-and-progenitor-cells-cd3-t-cells-treatment-solid-organ-transplantation_en.pdf"},
    {"id":"43187","name":"EU/3/18/2059: Public summary of opinion on orphan designation: Acetylleucine for the treatment of spinocerebellar ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-20T10:19:00Z","last_updated_date":"2018-12-20T10:19:00Z","reference_number":"EMA/530908/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182059-public-summary-opinion-orphan-designation-acetylleucine-treatment-spinocerebellar-ataxia_en.pdf"},
    {"id":"43188","name":"EU/3/18/2062: Public summary of opinion on orphan designation: Bertilimumab for the treatment of bullous pemphigoid","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-20T10:27:00Z","last_updated_date":"2018-12-20T10:27:00Z","reference_number":"EMA/533268/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182062-public-summary-opinion-orphan-designation-bertilimumab-treatment-bullous-pemphigoid_en.pdf"},
    {"id":"43189","name":"EU/3/18/2052: Public summary of opinion on orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-12-20T10:36:00Z","last_updated_date":"2022-10-21T10:46:00Z","reference_number":"EMA/530846/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182052-public-summary-opinion-orphan-designation-1-3-methylbutanoyl-l-aspartyl-l-threonyl-l-histidyl-l-phenylalanyl-l-prolyl-l-cystinyl-l-isoleucyl-n6-s-4-carboxy-4-palmitamidobutanoyl-l-lysinyl-l_en.pdf"},
    {"id":"43190","name":"Presentation - Fass – Electronic product information in Sweden (G. Englund)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-20T12:26:00Z","last_updated_date":"2018-12-20T12:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fass-electronic-product-information-sweden-g-englund_en.pdf"},
    {"id":"43191","name":"Presentation - Digitising product information: Greater accessibility for public health and all patients (N. Knight and J. Moreland)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-20T12:27:00Z","last_updated_date":"2018-12-20T12:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-digitising-product-information-greater-accessibility-public-health-and-all-patients-n-knight-and-j-moreland_en.pdf"},
    {"id":"43192","name":"Presentation - E-PIL Belgium & Luxembourg Pioneer Pilot Project (N. Lambot)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-20T12:30:00Z","last_updated_date":"2018-12-20T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-e-pil-belgium-luxembourg-pioneer-pilot-project-n-lambot_en.pdf"},
    {"id":"43193","name":"Presentation - Product Information 4.0 “Gebrauchsinformation 4.0 (GI 4.0)” (G. Lang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-20T12:32:00Z","last_updated_date":"2018-12-20T12:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-information-40-gebrauchsinformation-40-gi-40-g-lang_en.pdf"},
    {"id":"43194","name":"Presentation - A future perspective: Tailored, integrated digital health information","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-20T12:35:00Z","last_updated_date":"2018-12-20T12:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-future-perspective-tailored-integrated-digital-health-information_en.pdf"},
    {"id":"43195","name":"Presentation - Common electronic standard: potential features and use cases (E. Scanlan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2018-12-20T12:38:00Z","last_updated_date":"2018-12-20T12:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-common-electronic-standard-potential-features-and-use-cases-e-scanlan_en.pdf"},
    {"id":"43209","name":"Veterinary medicines highlights 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-01-04T12:00:00Z","last_updated_date":"2019-01-04T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/veterinary-medicines-highlights-2018_en.pdf"},
    {"id":"43210","name":"Human medicines highlights 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-01-04T10:00:00Z","last_updated_date":"2019-01-04T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2018_en.pdf"},
    {"id":"43211","name":"EU/3/18/2074: Public summary of opinion on orphan designation: Avapritinib for the treatment of mastocytosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-04T13:05:00Z","last_updated_date":"2019-01-04T13:05:00Z","reference_number":"EMA/674141/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182074-public-summary-opinion-orphan-designation-avapritinib-treatment-mastocytosis_en.pdf"},
    {"id":"43217","name":"CHMP ORGAM agenda for the meeting on 4 December 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T08:35:00Z","last_updated_date":"2019-01-07T08:35:00Z","reference_number":"EMA/848375/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-4-december-2018_en.pdf"},
    {"id":"43219","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 19-20 November 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T10:30:00Z","last_updated_date":"2019-01-07T10:30:00Z","reference_number":"EMA/HMPC/204861/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-19-20-november-2018_en.pdf"},
    {"id":"43220","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T09:46:00Z","last_updated_date":"2019-01-07T09:46:00Z","reference_number":"EMA/814866/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-virus-serotype-9-vector-encoding-soluble-lysosomal-enzyme-tpp1_en.pdf"},
    {"id":"43221","name":"Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T09:46:00Z","last_updated_date":"2019-01-07T09:46:00Z","reference_number":"EMA/814824/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-codon-optimized-mrna-will-be-translated-functional-human-cystic-fibrosis-transmembrane-conductance-regulator-protein-after_en.pdf"},
    {"id":"43222","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T09:46:00Z","last_updated_date":"2019-01-07T09:46:00Z","reference_number":"EMA/814789/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-cultured-autologous-mesenchymal-stem-cells-isolated-bone-marrow_en.pdf"},
    {"id":"43223","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T09:46:00Z","last_updated_date":"2019-01-07T09:46:00Z","reference_number":"EMA/814774/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-cultured-autologous-mesenchymal-stem-cells-isolated-bone-marrow_en.pdf-0"},
    {"id":"43224","name":"Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T09:46:00Z","last_updated_date":"2019-01-07T09:46:00Z","reference_number":"EMA/813715/2018","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicines-allogeneic-epstein-barr-virus-specific-cytotoxic-t-lymphocytes_en.pdf"},
    {"id":"43225","name":"What’s new in pharmacovigilance - QPPV Update - Issue 2 - 2018","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T11:53:00Z","last_updated_date":"2019-01-07T11:53:00Z","reference_number":"Issue 2","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-2-2018_en.pdf"},
    {"id":"43227","name":"CHMP ORGAM agenda for the meeting on 5 November 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2019-01-07T12:03:00Z","last_updated_date":"2019-01-07T12:03:00Z","reference_number":"EMA/CHMP/777011/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-5-november-2018_en.pdf"},
    {"id":"43230","name":"Presentation - Session 3 - MT - Answers to breakout sessions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-mt-answers-breakout-sessions_en.pdf"},
    {"id":"43231","name":"List of participants - EU-Innovation network workshop with academia","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-eu-innovation-network-workshop-academia_en.pdf"},
    {"id":"43232","name":"Presentation - Session 1 - New clinical trial regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-new-clinical-trial-regulation_en.pdf"},
    {"id":"43233","name":"Presentation - Session 1 - The role of EMA in promoting innovation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-role-ema-promoting-innovation_en.pdf"},
    {"id":"43234","name":"Presentation - Session 1 - What is the EU Innovation Network","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-what-eu-innovation-network_en.pdf"},
    {"id":"43235","name":"Presentation - Session 2 - DG RTD perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-dg-rtd-perspective_en.pdf"},
    {"id":"43236","name":"Presentation - Session 2 - EU funded  initiatives - EU infrastructures - EATRIS","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-eu-funded-initiatives-eu-infrastructures-eatris_en.pdf"},
    {"id":"43237","name":"Presentation - Session 2 - EU funded  initiatives - EU infrastructures - ECRIN","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-eu-funded-initiatives-eu-infrastructures-ecrin_en.pdf"},
    {"id":"43238","name":"Presentation - Session 2 - EU funded  initiatives - EU infrastructures - ELIXIR","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-eu-funded-initiatives-eu-infrastructures-elixir_en.pdf"},
    {"id":"43239","name":"Presentation - Session 2 - EU funded initiatives - CSA STARS","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-eu-funded-initiatives-csa-stars_en.pdf"},
    {"id":"43240","name":"Presentation - Session 2 - EU funded initiatives - EU infrastructures - BBMRI","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-eu-funded-initiatives-eu-infrastructures-bbmri_en.pdf"},
    {"id":"43241","name":"Presentation - Session 3 - AT - Answers to breakout sessions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-answers-breakout-sessions_en.pdf"},
    {"id":"43242","name":"Presentation - Session 3 - CZ - Answers to breakout sessions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-cz-answers-breakout-sessions_en.pdf"},
    {"id":"43243","name":"Presentation - Session 3 - ES - Answers to breakout sessions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-es-answers-breakout-sessions_en.pdf"},
    {"id":"43244","name":"Presentation - Session 3 - IE - Answers to breakout sessions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-07T14:59:00Z","last_updated_date":"2019-01-07T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-ie-answers-breakout-sessions_en.pdf"},
    {"id":"43256","name":"Questions and answers on the refusal of a change to the marketing authorisations for Opdivo (nivolumab) and Yervoy (ipilimumab)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:06:00Z","last_updated_date":"2018-07-27T14:06:00Z","reference_number":"EMA/568014/2018 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisations-opdivo-nivolumab-and-yervoy-ipilimumab_en.pdf"},
    {"id":"43257","name":"Questions and answers on the refusal of a change to the marketing authorisation for Blincyto","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:10:00Z","last_updated_date":"2018-07-27T14:10:00Z","reference_number":"EMA/622207/2018 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-blincyto_en.pdf"},
    {"id":"43260","name":"Manufacturer organisations in the OMS dictionary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T10:00:00Z","last_updated_date":"2019-01-11T10:00:00Z","reference_number":"EMA/465039/2018","document_url":"https://www.ema.europa.eu/en/documents/other/manufacturer-organisations-oms-dictionary_en.pdf"},
    {"id":"43261","name":"Questions and answers on the CVMP guideline on the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/77872/2018)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-01-09T16:00:00Z","last_updated_date":"2019-01-09T16:00:00Z","reference_number":"EMA/CVMP/EWP/77872/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-cvmp-guideline-guideline-veterinary-medicinal-products-controlling-varroa-destructor-parasitosis-bees-emacvmpewp778722018_en.pdf"},
    {"id":"43262","name":"Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-01-09T17:00:00Z","last_updated_date":"2019-01-09T17:00:00Z","reference_number":"EMA/CVMP/SWP/377245/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-assessment-and-control-dna-reactive-mutagenic-impurities-veterinary-medicinal-products_en.pdf"},
    {"id":"43263","name":"Overview of comments received on guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2019-01-09T16:00:00Z","last_updated_date":"2019-01-09T16:00:00Z","reference_number":"EMA/CVMP/SWP/610519/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-assessment-and-control-dna-reactive-mutagenic-impurities-veterinary-medicinal-products-emacvmpswp3772452016_en.pdf"},
    {"id":"43264","name":"Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-01-09T17:00:00Z","last_updated_date":"2019-01-09T17:00:00Z","reference_number":"EMA/CVMP/IWP/105506/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-revision-1_en.pdf"},
    {"id":"43265","name":"Overview of comments received on 'Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD)' - Revision 1","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2019-01-09T17:00:00Z","last_updated_date":"2019-01-09T17:00:00Z","reference_number":"EMA/CVMP/IWP/235788/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-revision-1_en.pdf"},
    {"id":"43266","name":"Questions and answers on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-01-09T17:00:00Z","last_updated_date":"2019-01-09T17:00:00Z","reference_number":"EMA/CVMP/IWP/466888/2017 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-revision-1_en.pdf"},
    {"id":"43267","name":"European Medicines Agency budget for 2019","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T09:30:00Z","last_updated_date":"2019-01-10T09:30:00Z","reference_number":"EMA/MB/647697/2018","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-budget-2019_en.pdf"},
    {"id":"43273","name":"Presentation - Perspective from European Union - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (V. Jekerle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:37:00Z","last_updated_date":"2019-01-10T12:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-perspective-european-union-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-v-jekerle_en.pdf"},
    {"id":"43274","name":"Presentation - Session 1 - Setting the scene - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (E. Alteri, V. Jekerle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:41:00Z","last_updated_date":"2019-01-10T12:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-setting-scene-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-e-alteri-v-jekerle_en.pdf"},
    {"id":"43275","name":"Presentation - Session 1 - FDA perspective - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (Ramesh K. Sood)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:44:00Z","last_updated_date":"2019-01-10T12:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-fda-perspective-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-ramesh-k-sood_en.pdf"},
    {"id":"43276","name":"Presentation - Session 2 - Process validation and accelerated access - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (S. Barry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:45:00Z","last_updated_date":"2019-01-10T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-process-validation-and-accelerated-access-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-s-barry_en.pdf"},
    {"id":"43277","name":"Presentation - Session 2 - Innovative validation - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (S. Finn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:52:00Z","last_updated_date":"2019-01-10T12:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-innovative-validation-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-s-finn_en.pdf"},
    {"id":"43278","name":"Presentation - Session 3.1 - Control strategy: Regulators perspective - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (M. Wellin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:57:00Z","last_updated_date":"2019-01-10T12:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-31-control-strategy-regulators-perspective-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-m-wellin_en.pdf"},
    {"id":"43279","name":"Presentation - Session 3.2 - Control strategy: Industry perspective - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (D. Wilkinson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:59:00Z","last_updated_date":"2019-01-10T12:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-32-control-strategy-industry-perspective-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-d-wilkinson_en.pdf"},
    {"id":"43280","name":"Presentation - Session 3.3 - Control strategy: Industry perspective - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (C. Campa)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:01:00Z","last_updated_date":"2019-01-10T13:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-33-control-strategy-industry-perspective-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-c-campa_en.pdf"},
    {"id":"43281","name":"Presentation - Session 4.1 - Good manufacturing practice - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (G. Lorenti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:04:00Z","last_updated_date":"2019-01-10T13:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-41-good-manufacturing-practice-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-g-lorenti_en.pdf"},
    {"id":"43282","name":"Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:05:00Z","last_updated_date":"2019-01-10T12:05:00Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/lorazepam-list-nationally-authorised-medicinal-products-psusa00001909201801_en.pdf"},
    {"id":"43283","name":"Lorazepam: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001909/201801","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:07:00Z","last_updated_date":"2019-01-10T12:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/lorazepam-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001909201801_sv.pdf"}},
    {"id":"43284","name":"Presentation - Session 4.2 - Good manufacturing practice considerations for accelerated access - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (M. Popkin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:07:00Z","last_updated_date":"2019-01-10T13:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-42-good-manufacturing-practice-considerations-accelerated-access-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-m_en.pdf"},
    {"id":"43285","name":"Presentation - Session 5.1 - Setting specification acceptance criteria - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (R. Keane, N. Frantz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:11:00Z","last_updated_date":"2019-01-10T13:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-51-setting-specification-acceptance-criteria-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-r-keane-n-frantz_en.pdf"},
    {"id":"43286","name":"BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T12:13:00Z","last_updated_date":"2019-01-10T12:13:00Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/bcg-vaccine-freeze-dried-list-nationally-authorised-medicinal-products-psusa00000304201803_en.pdf"},
    {"id":"43287","name":"BCG vaccine (freeze-dried): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation  - 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-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00000304201803_no.pdf"}},
    {"id":"43288","name":"Presentation - Session 5.2 - Ebola case study- Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (T. Pepper)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:18:00Z","last_updated_date":"2019-01-10T13:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-52-ebola-case-study-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-t-pepper_en.pdf"},
    {"id":"43289","name":"Presentation - Session 5b - Case study on control strategy: impurity control strategy for an oncology drug  - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (A. Teasdale)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:21:00Z","last_updated_date":"2019-01-10T13:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5b-case-study-control-strategy-impurity-control-strategy-oncology-drug-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough_en.pdf"},
    {"id":"43290","name":"Presentation - Session 6.1 - Risk-based assessment of comparability for a mAb undergoing accelerated development - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (A. Clinch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:24:00Z","last_updated_date":"2019-01-10T13:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-61-risk-based-assessment-comparability-mab-undergoing-accelerated-development-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough_en.pdf"},
    {"id":"43291","name":"Presentation - Session 6.2 - Advanced therapy medicinal products (ATMPs) comparability challenge case study - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (M. Jeschke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:27:00Z","last_updated_date":"2019-01-10T13:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-62-advanced-therapy-medicinal-products-atmps-comparability-challenge-case-study-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and_en.pdf"},
    {"id":"43292","name":"Presentation - Session 6.3 - Advanced therapy medicinal products (ATMPs) comparability challenge case study - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (M. Alai-Safar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:34:00Z","last_updated_date":"2019-01-10T13:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-63-advanced-therapy-medicinal-products-atmps-comparability-challenge-case-study-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and_en.pdf"},
    {"id":"43293","name":"Presentation - Session 6b - Stability approaches - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (R. Ogilvie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:37:00Z","last_updated_date":"2019-01-10T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-6b-stability-approaches-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-r-ogilvie_en.pdf"},
    {"id":"43294","name":"Presentation - Session 7.1 - Predictive stability models to extrapolate shelf-life - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (A. Lennard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:41:00Z","last_updated_date":"2019-01-10T13:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-71-predictive-stability-models-extrapolate-shelf-life-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-lennard_en.pdf"},
    {"id":"43295","name":"Presentation - Session 9.1 - Regulatory tools - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (Y. Momonoi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:44:00Z","last_updated_date":"2019-01-10T13:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-91-regulatory-tools-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-y-momonoi_en.pdf"},
    {"id":"43296","name":"Presentation - Session 9.3 - Regulatory tools - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (C. Blanc, C. Bouygues)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:47:00Z","last_updated_date":"2019-01-10T13:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-93-regulatory-tools-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-c-blanc-c-bouygues_en.pdf"},
    {"id":"43297","name":"Presentation - Session 9.4 - Regulatory tools - FDA - Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies (A. Byrnes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-10T13:50:00Z","last_updated_date":"2019-01-10T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-94-regulatory-tools-fda-stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-and-breakthrough-therapies-byrnes_en.pdf"},
    {"id":"43305","name":"EU/3/18/2075: Public summary of positive opinion for orphan designation: Gefinitib for the treatment of Fanconi anaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T16:07:00Z","last_updated_date":"2019-01-10T16:07:00Z","reference_number":"EMA/674771/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182075-public-summary-positive-opinion-orphan-designation-gefinitib-treatment-fanconi-anaemia_en.pdf"},
    {"id":"43306","name":"EU/3/18/2078: Public summary of opinion on orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG for treatment of multiple myeloma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T16:27:00Z","last_updated_date":"2019-01-10T16:27:00Z","reference_number":"EMA/678538/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182078-public-summary-opinion-orphan-designation-peptides-ymfpnapyl-sgqaymfpnapylpscles-rsdelvrhhnmhqrnmtkl-and-pgcnkryfklshlqmhsrkhtg-treatment-multiple-myeloma_en.pdf"},
    {"id":"43307","name":"EU/3/18/2076: Public summary of opinion on orphan designation: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan..","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T16:41:00Z","last_updated_date":"2020-02-03T17:08:00Z","reference_number":"EMA/658184/2018 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182076-public-summary-opinion-orphan-designation-glycine-l-alanine-l-arginine-l-aspartic-acid-l-cysteine-l-glutamic-acid-l-histidine-l-lysine-monohydrate-l-methionine-l-phenylalanine-l-proline-l_en.pdf"},
    {"id":"43308","name":"EU/3/18/2079: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coag...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T17:06:00Z","last_updated_date":"2019-01-10T17:06:00Z","reference_number":"EMA/661289/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182079-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-containing-bioengineered-capsid-and-codon-optimised-expression-cassette-drive-expression-sq-form-b-domain_en.pdf"},
    {"id":"43309","name":"EU/3/18/2073: Public summary of opinion on orphan designation: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA for the treatment of mucopolysac...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T17:43:00Z","last_updated_date":"2019-01-10T17:43:00Z","reference_number":"EMA/650328/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182073-public-summary-opinion-orphan-designation-autologous-cd34-haematopoietic-stem-and-progenitor-cells-genetically-modified-lentiviral-vector-idua-lv-encoding-alpha-l-iduronidase-cdna-treatment_en.pdf"},
    {"id":"43310","name":"EU/3/18/2070: Public summary of opinion on orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid for the treatment of dermatomyositis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-10T17:51:00Z","last_updated_date":"2019-01-10T17:51:00Z","reference_number":"EMA/688517/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182070-public-summary-opinion-orphan-designation-6ar10ar-3-11-dimethylheptyl-delta8-tetrahydro-cannabinol-9-carboxylic-acid-treatment-dermatomyositis_en.pdf"},
    {"id":"43311","name":"EU/3/18/2071: Public summary of opinion on orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile for the treatment of medullary t...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-11T10:53:00Z","last_updated_date":"2019-01-11T10:53:00Z","reference_number":"EMA/680129/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182071-public-summary-opinion-orphan-designation-6-2-hydroxy-2-methylpropoxy-4-6-6-6-methoxypyridin-3-ylmethyl-36-diazabicyclo311heptan-3-ylpyridin-3-ylpyrazolo15-apyridine-3-carbonitrile-treatment_en.pdf"},
    {"id":"43312","name":"Presentation - Session 1: Regulation of veterinary medicinal products in the 21st century: addressing challenges and opportunities across the European Regulatory Framework (Ivo Claassen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:07:00Z","last_updated_date":"2019-01-11T11:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-regulation-veterinary-medicinal-products-21st-century-addressing-challenges-and-opportunities-across-european-regulatory-framework-ivo-claassen_en.pdf"},
    {"id":"43313","name":"Presentation - Session 1: Integration of Agency Committees and Network into delivery of the strategy (David Murphy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:09:00Z","last_updated_date":"2019-01-11T11:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-integration-agency-committees-and-network-delivery-strategy-david-murphy_en.pdf"},
    {"id":"43314","name":"EU/3/18/2080: Public summary of opinion on orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-11T11:11:00Z","last_updated_date":"2019-01-11T11:11:00Z","reference_number":"EMA/667696/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182080-public-summary-opinion-orphan-designation-recombinant-adeno-associated-viral-vector-serotype-s3-containing-codon-optimised-expression-cassette-encoding-human-coagulation-factor-ix-variant_en.pdf"},
    {"id":"43315","name":"Presentation - Session 1: Regulatory Science to 2025: view from the European Commission (Christian Siebert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:11:00Z","last_updated_date":"2019-01-11T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-regulatory-science-2025-view-european-commission-christian-siebert_en.pdf"},
    {"id":"43316","name":"Presentation - Session 1: View from European Medicines Regulatory Network (Jean-Pierre Orand)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:15:00Z","last_updated_date":"2019-01-11T11:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-view-european-medicines-regulatory-network-jean-pierre-orand_en.pdf"},
    {"id":"43317","name":"Presentation - Session 1: Challenges and opportunities across theregulatory framework: view from veterinarians (Nancy De Briyne)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:18:00Z","last_updated_date":"2019-01-11T11:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-challenges-and-opportunities-across-theregulatory-framework-view-veterinarians-nancy-de-briyne_en.pdf"},
    {"id":"43318","name":"(2018)2354: Public summary of negative opinion for orphan designation: Autologous skeletal myoblasts expanded ex vivo for the treatment of oculopharyngeal muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-11T11:20:00Z","last_updated_date":"2019-01-11T11:20:00Z","reference_number":"EMA/689216/2018 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/20182354-public-summary-negative-opinion-orphan-designation-autologous-skeletal-myoblasts-expanded-ex-vivo-treatment-oculopharyngeal-muscular-dystrophy_en.pdf"},
    {"id":"43319","name":"Presentation - Session 1: Challenges and opportunities across the European Regulatory Framework: view for the animal medicines industry (Alexander Böttner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:36:00Z","last_updated_date":"2019-01-11T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-challenges-and-opportunities-across-european-regulatory-framework-view-animal-medicines-industry-alexander-bottner_en.pdf"},
    {"id":"43320","name":"Presentation - Session 2: Veterinary vaccines: proposal to facilitate licensing in general (Carmen Jungbaeck)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:38:00Z","last_updated_date":"2019-01-11T11:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-veterinary-vaccines-proposal-facilitate-licensing-general-carmen-jungbaeck_en.pdf"},
    {"id":"43321","name":"Presentation - Session 2: Catalysing the integration of science and technology in drug development (Rory Breathnach)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:39:00Z","last_updated_date":"2019-01-11T11:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-catalysing-integration-science-and-technology-drug-development-rory-breathnach_en.pdf"},
    {"id":"43322","name":"Presentation - Session 2: Catalysing the integration of science and technology in development (Jackie Atkinson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:40:00Z","last_updated_date":"2019-01-11T11:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-catalysing-integration-science-and-technology-development-jackie-atkinson_en.pdf"},
    {"id":"43323","name":"Presentation - Session 2: Association of Veterinary Consultants (Klaus Hellmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:41:00Z","last_updated_date":"2019-01-11T11:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-association-veterinary-consultants-klaus-hellmann_en.pdf"},
    {"id":"43324","name":"Presentation - Session 2: RS to 2025: catalysing the integration of science and technology in drug development (Lindsay Marshall)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:44:00Z","last_updated_date":"2019-01-11T11:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-rs-2025-catalysing-integration-science-and-technology-drug-development-lindsay-marshall_en.pdf"},
    {"id":"43325","name":"EU/3/18/2072: Public summary of opinion on orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate for the treatment of cystic fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-01-11T11:44:00Z","last_updated_date":"2019-01-11T11:44:00Z","reference_number":"EMA/680124/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182072-public-summary-opinion-orphan-designation-6-r-methyl-5-o-5-amino-56-dideoxy-alpha-l-talofuranosyl-paromamine-sulfate-treatment-cystic-fibrosis_en.pdf"},
    {"id":"43326","name":"Presentation - Session 3: Driving collaborative evidence generation and improving the scientific quality of evaluations (Nicholas Jarrett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:46:00Z","last_updated_date":"2019-01-11T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-driving-collaborative-evidence-generation-and-improving-scientific-quality-evaluations-nicholas-jarrett_en.pdf"},
    {"id":"43327","name":"Presentation - Veterinary Stakeholders Workshop: European Group for Generic Veterinary Products (EGGVP) (Elsa Vecino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:49:00Z","last_updated_date":"2019-01-11T11:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-stakeholders-workshop-european-group-generic-veterinary-products-eggvp-elsa-vecino_en.pdf"},
    {"id":"43328","name":"Presentation - Session 3: Driving collaborative evidence generation: improving the scientific quality of evaluations (Jaques Lechenet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T11:51:00Z","last_updated_date":"2019-01-11T11:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-driving-collaborative-evidence-generation-improving-scientific-quality-evaluations-jaques-lechenet_en.pdf"},
    {"id":"43329","name":"Presentation - Session 4: Addressing emerging health threats and availability/therapeutic challenges (Helen Jukes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T12:02:00Z","last_updated_date":"2019-01-11T12:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-addressing-emerging-health-threats-and-availabilitytherapeutic-challenges-helen-jukes_en.pdf"},
    {"id":"43330","name":"Presentation - Session 4: Addressing emerging health threats and availability/therapeutic challenges (Alexander Boettner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T12:11:00Z","last_updated_date":"2019-01-11T12:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-addressing-emerging-health-threats-and-availabilitytherapeutic-challenges-alexander-boettner_en.pdf"},
    {"id":"43331","name":"Presentation - Session 4: Veterinary vaccines: proposal to facilitate licensing in exceptional circumstances (emergency) (Carmen Jungbaeck)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T12:12:00Z","last_updated_date":"2019-01-11T12:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-veterinary-vaccines-proposal-facilitate-licensing-exceptional-circumstances-emergency-carmen-jungbaeck_en.pdf"},
    {"id":"43332","name":"Presentation - Session 4: Addressing emerging health threats and availability/therapeutic challenges (Georg von Samson-Himmelstjerna)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T12:14:00Z","last_updated_date":"2019-01-11T12:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-addressing-emerging-health-threats-and-availabilitytherapeutic-challenges-georg-von-samson-himmelstjerna_en.pdf"},
    {"id":"43333","name":"Presentation - Session 4: Addressing emerging health threats and availability/therapeutic challenges (Rens van Dobbenburgh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T12:17:00Z","last_updated_date":"2019-01-11T12:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-addressing-emerging-health-threats-and-availabilitytherapeutic-challenges-rens-van-dobbenburgh_en.pdf"},
    {"id":"43334","name":"Presentation - Session 5: Enabling and leveraging research and innovation in regulatory science (Tony Humphreys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-01-11T12:22:00Z","last_updated_date":"2019-01-11T12:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-enabling-and-leveraging-research-and-innovation-regulatory-science-tony-humphreys_en.pdf"},
    {"id":"43353","name":"Extension of reserve lists for external selection procedures: Contract Agent reserve list","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-01-14T16:32:00Z","last_updated_date":"2023-01-23T11:00:00Z","reference_number":"EMA/34904/2023","document_url":"https://www.ema.europa.eu/en/documents/other/extension-reserve-lists-external-selection-procedures-contract-agent-reserve-list_en.pdf"},
    {"id":"43354","name":"Extension of reserve lists for external selection procedures: Temporary Agent reserve lists","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-01-14T16:33:00Z","last_updated_date":"2023-06-19T14:34:00Z","reference_number":"EMA/34905/2023","document_url":"https://www.ema.europa.eu/en/documents/other/extension-reserve-lists-external-selection-procedures-temporary-agent-reserve-lists_en.pdf"},
    {"id":"43355","name":"Human medicines highlights - January 2019","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2019-01-14T15:40:00Z","last_updated_date":"2019-01-14T15:40:00Z","reference_number":"Issue 118","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-january-2019_en.pdf"},
    {"id":"43361","name":"Agenda - PRAC draft agenda of meeting 14-17 January 2019","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2019-01-14T17:55:00Z","last_updated_date":"2019-01-14T17:55:00Z","reference_number":"EMA/PRAC/10734/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-14-17-january-2019_en.pdf"},
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    {"id":"43878","name":"CVMP summary of positive opinion for HorStem","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-02-22T16:24:00Z","last_updated_date":"2019-02-22T16:24:00Z","reference_number":"EMA/CVMP/131410/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-horstem_en.pdf"},
    {"id":"43879","name":"CVMP summary of positive opinion for Forceris","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-02-22T16:33:00Z","last_updated_date":"2019-02-22T16:33:00Z","reference_number":"EMA/CVMP/64773/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-forceris_en.pdf"},
    {"id":"43881","name":"CVMP summary of positive opinion for Chanhold","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-02-22T16:44:00Z","last_updated_date":"2019-02-22T16:44:00Z","reference_number":"EMA/CVMP/64944/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-chanhold_en.pdf"},
    {"id":"43882","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 February 2019","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-02-22T17:00:00Z","last_updated_date":"2019-02-22T17:00:00Z","reference_number":"EMA/CVMP/106690/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-february-2019_en.pdf"},
    {"id":"43883","name":"Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC September 2018 meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T08:56:00Z","last_updated_date":"2019-02-25T08:56:00Z","reference_number":"EMA/HMPC/41915/2019","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-aesgp-during-hmpc-september-2018-meeting_en.pdf"},
    {"id":"43884","name":"Guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-02-25T11:12:00Z","last_updated_date":"2019-02-25T11:12:00Z","reference_number":"EMEA/HMPC/32116/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-non-clinical-documentation-applications-marketing-authorisationregistration-well-established-and-traditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"43885","name":"Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries - Revision 2","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T10:33:00Z","last_updated_date":"2019-02-25T10:33:00Z","reference_number":"EMA/HMPC/137093/2006 Rev.2 ","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-information-exchange-preparation-assessment-report-supporting-establishment-european-union-monographs-and-european-union-list-entries-revision-2_en.doc"},
    {"id":"43886","name":"EU/3/18/2098: Public summary of opinion on orphan designation: Larotrectinib for the treatment of papillary thyroid cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-22T11:37:00Z","last_updated_date":"2019-10-24T17:00:00Z","reference_number":"EMA/776179/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182098-public-summary-opinion-orphan-designation-larotrectinib-treatment-papillary-thyroid-cancer_en.pdf"},
    {"id":"43887","name":"EU/3/18/2083: Public summary of opinion on orphan designation: Allogeneic faecal microbiota, pooled for the treatment of graft-versus-host disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T11:59:00Z","last_updated_date":"2019-02-25T11:59:00Z","reference_number":"EMA/763197/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182083-public-summary-opinion-orphan-designation-allogeneic-faecal-microbiota-pooled-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"43888","name":"EU/3/18/2099: Public summary of opinion on orphan designation: Lisocabtagene maraleucel for the treatment of primary mediastinal large B-cell lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T12:22:00Z","last_updated_date":"2022-02-21T13:35:00Z","reference_number":"EMA/759232/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182099-public-summary-opinion-orphan-designation-lisocabtagene-maraleucel-treatment-primary-mediastinal-large-b-cell-lymphoma_en.pdf"},
    {"id":"43889","name":"EU/3/18/2094: Public summary of opinion on orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised for the treatment of neuroblastoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T12:34:00Z","last_updated_date":"2019-02-25T12:34:00Z","reference_number":"EMA/769941/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182094-public-summary-opinion-orphan-designation-anti-gd2-monoclonal-antibody-3f8-humanised-treatment-neuroblastoma_en.pdf"},
    {"id":"43890","name":"EU/3/18/2089: Public summary of opinion on orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T12:44:00Z","last_updated_date":"2019-02-25T12:44:00Z","reference_number":"EMA/754017/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182089-public-summary-opinion-orphan-designation-ex-vivo-fused-normal-allogeneic-human-myoblast-autologous-human-myoblast-derived-duchenne-muscular-dystrophy-affected-donor-treatment-duchenne_en.pdf"},
    {"id":"43891","name":"EU/3/18/2088: Public summary of opinion on orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T13:13:00Z","last_updated_date":"2019-02-25T13:13:00Z","reference_number":"EMA/754015/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182088-public-summary-opinion-orphan-designation-ex-vivo-fused-normal-allogeneic-human-myoblast-another-normal-allogeneic-human-myoblast-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"43892","name":"EU/3/18/2087: Public summary of opinion on orphan designation: Etamsylate for the treatment of hereditary haemorrhagic telangiectasia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T13:23:00Z","last_updated_date":"2019-02-25T13:23:00Z","reference_number":"EMA/750060/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182087-public-summary-opinion-orphan-designation-etamsylate-treatment-hereditary-haemorrhagic-telangiectasia_en.pdf"},
    {"id":"43893","name":"EU/3/18/2101: Public summary of opinion on orphan designation: Setmelanotide for the treatment of leptin receptor deficiency","type":"orphan-review","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T13:33:00Z","last_updated_date":"2019-02-25T13:33:00Z","reference_number":"EMA/756623/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/eu3182101-public-summary-opinion-orphan-designation-setmelanotide-treatment-leptin-receptor-deficiency_en.pdf"},
    {"id":"43894","name":"EU/3/18/2092: Public summary of opinion on orphan designation: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-213-bismuth for the treatment of glioma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T15:21:00Z","last_updated_date":"2019-02-25T15:21:00Z","reference_number":"EMA/776530/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182092-public-summary-opinion-orphan-designation-h-arg-pro-lys-pro-gln-gln-phe-2thi-gly-leu-meto2-nh2-dota-213-bismuth-treatment-glioma_en.pdf"},
    {"id":"43895","name":"EU/3/18/2095: Public summary of opinion on orphan designation: Ile-Ser-Ile-Thr-Glu-Ile-Lys-Gly-Val-Ile-Val-His-Arg-Ile-Glu-Thr-Ile-Leu-Phe-Lys-Lys-Lys-Lys-Glu-Met-Pro-Ser-Glu-Glu-Gly-Tyr-Gln-Asp for the treatment of multiple system atrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T15:33:00Z","last_updated_date":"2019-02-25T15:33:00Z","reference_number":"EMA/776496/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182095-public-summary-opinion-orphan-designation-ile-ser-ile-thr-glu-ile-lys-gly-val-ile-val-his-arg-ile-glu-thr-ile-leu-phe-lys-lys-lys-lys-glu-met-pro-ser-glu-glu-gly-tyr-gln-asp-treatment_en.pdf"},
    {"id":"43896","name":"EU/3/18/2084: Public summary of opinion on orphan designation: Anetumab ravtansine for the treatment of ovarian cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-02-25T15:43:00Z","last_updated_date":"2022-02-01T11:19:00Z","reference_number":"EMA/765821/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182084-public-summary-opinion-orphan-designation-anetumab-ravtansine-treatment-ovarian-cancer_en.pdf"},
    {"id":"43926","name":"CHMP summary of positive opinion for Dectova","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T10:22:00Z","last_updated_date":"2019-03-01T10:22:00Z","reference_number":"EMA/CHMP/851518/2018","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dectova_en.pdf"},
    {"id":"43927","name":"CHMP summary of positive opinion for Skyrizi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T10:43:00Z","last_updated_date":"2019-03-01T10:43:00Z","reference_number":"EMA/CHMP/132686/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-skyrizi_en.pdf"},
    {"id":"43931","name":"Question and answer on adjustment for cross-over in estimating effects in oncology trials","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-02-28T11:29:00Z","last_updated_date":"2019-02-28T11:29:00Z","reference_number":"EMA/845963/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/question-and-answer-adjustment-cross-over-estimating-effects-oncology-trials_en.pdf"},
    {"id":"43932","name":"CHMP summary of positive opinion for Palynziq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T13:55:00Z","last_updated_date":"2019-03-01T13:55:00Z","reference_number":"EMA/CHMP/139000/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-palynziq_en.pdf"},
    {"id":"43934","name":"CHMP post-authorisation summary of positive opinion for Trydonis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T13:58:00Z","last_updated_date":"2019-03-01T13:58:00Z","reference_number":"EMA/CHMP/136916/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trydonis_en.pdf"},
    {"id":"43935","name":"CHMP post-authorisation summary of positive opinion for Viread (II-191)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T12:00:00Z","last_updated_date":"2019-03-01T12:00:00Z","reference_number":"EMA/CHMP/129761/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-viread-ii-191_en.pdf"},
    {"id":"43936","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 25-28 February 2019","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T12:42:00Z","last_updated_date":"2019-03-01T12:42:00Z","reference_number":"EMA/CHMP/SAWP/147640/2019","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-25-28-february-2019_en.pdf"},
    {"id":"43937","name":"Joint MHLW/EMA reflection paper on the development of block copolymer micelle medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2014-01-10T15:44:00Z","last_updated_date":"2014-01-10T15:44:00Z","reference_number":"EMA/CHMP/13099/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/joint-mhlwema-reflection-paper-development-block-copolymer-micelle-medicinal-products_en.pdf"},
    {"id":"43938","name":"Withdrawal letter : Epjevy","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T15:52:00Z","last_updated_date":"2019-03-01T15:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-epjevy_en.pdf"},
    {"id":"43939","name":"CHMP summary of positive opinion for Zynquista","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T12:00:00Z","last_updated_date":"2022-08-16T15:30:00Z","reference_number":"EMA/CHMP/138211/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zynquista_en.pdf"},
    {"id":"43940","name":"CHMP summary of positive opinion for Ondexxya","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T12:00:00Z","last_updated_date":"2019-03-01T12:00:00Z","reference_number":"EMA/CHMP/40684/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ondexxya_en.pdf"},
    {"id":"43942","name":"CHMP summary of positive opinion for Waylivra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T12:00:00Z","last_updated_date":"2019-03-01T12:00:00Z","reference_number":"EMA/CHMP/130311/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-waylivra_en.pdf"},
    {"id":"43943","name":"Qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-02-28T18:00:00Z","last_updated_date":"2019-02-28T18:00:00Z","reference_number":"EMA/CHMP/SAWP/792574/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/qualification-opinion-cellular-therapy-module-european-society-blood-marrow-transplantation-ebmt-registry_en.pdf"},
    {"id":"43944","name":"Overview of comments received on 'Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry' (EMA/CHMP/SAWP/423488/2018)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2019-02-28T18:01:00Z","last_updated_date":"2019-02-28T18:01:00Z","reference_number":"EMA/618737/2018","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-qualification-opinion-cellular-therapy-module-european-society-blood-marrow-transplantation-ebmt-registry-emachmpsawp4234882018_en.pdf"},
    {"id":"43946","name":"CHMP summary of positive opinion for Lorviqua","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T09:48:00Z","last_updated_date":"2019-03-01T09:48:00Z","reference_number":"EMA/CHMP/34031/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lorviqua_en.pdf"},
    {"id":"43947","name":"CHMP post-authorisation summary of positive opinion for Lynparza (II-20)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T09:52:00Z","last_updated_date":"2019-03-01T09:52:00Z","reference_number":"EMA/CHMP/146940/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lynparza-ii-20_en.pdf"},
    {"id":"43948","name":"CHMP summary of positive opinion for Pazenir","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T09:55:00Z","last_updated_date":"2019-03-01T09:55:00Z","reference_number":"EMA/CHMP/147314/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pazenir_en.pdf"},
    {"id":"43953","name":"Press release - New add-on treatment for patients with severe asthma","type":"press-release","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T11:00:00Z","last_updated_date":"2019-03-01T11:00:00Z","reference_number":"EMA/CHMP/144932/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-new-add-treatment-patients-severe-asthma_en.pdf"},
    {"id":"43954","name":"Press release - First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T11:12:00Z","last_updated_date":"2019-03-01T11:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-first-antidote-reversal-anticoagulation-factor-xa-inhibitors-apixaban-and-rivaroxaban_en.pdf"},
    {"id":"43955","name":"Press release - New add-on treatment to insulin for treatment of certain patients with type 1 diabetes","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T11:17:00Z","last_updated_date":"2019-03-01T11:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-new-add-treatment-insulin-treatment-certain-patients-type-1-diabetes_en.pdf"},
    {"id":"43956","name":"Press release - First treatment for rare disease characterised by high levels of triglycerides in blood","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T12:00:00Z","last_updated_date":"2019-03-01T12:00:00Z","reference_number":"EMA/CHMP/143524/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-first-treatment-rare-disease-characterised-high-levels-triglycerides-blood_en.pdf"},
    {"id":"43957","name":"Questions and answers on the withdrawal of the marketing authorisation application for Epjevy (pacritinib citrate)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T12:42:00Z","last_updated_date":"2019-03-01T12:42:00Z","reference_number":"EMA/142005/2019","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-epjevy-pacritinib-citrate_en.pdf"},
    {"id":"43958","name":"Syner-Kinase Article 29(4) referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T12:00:00Z","last_updated_date":"2019-06-03T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/syner-kinase-article-294-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/syner-kinase-article-294-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/syner-kinase-article-294-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/syner-kinase-article-294-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/syner-kinase-article-294-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/syner-kinase-article-294-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/syner-kinase-article-294-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/syner-kinase-article-294-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/syner-kinase-article-294-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/syner-kinase-article-294-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/syner-kinase-article-294-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/syner-kinase-article-294-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/syner-kinase-article-294-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/syner-kinase-article-294-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/syner-kinase-article-294-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/syner-kinase-article-294-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/syner-kinase-article-294-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/syner-kinase-article-294-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/syner-kinase-article-294-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/syner-kinase-article-294-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/syner-kinase-article-294-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/syner-kinase-article-294-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/syner-kinase-article-294-referral-annex-iii_sv.pdf"}},
    {"id":"43960","name":"Press release - CHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-01T12:45:00Z","last_updated_date":"2019-03-01T12:45:00Z","reference_number":"EMA/CHMP/143328/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/press-release-chmp-recommends-authorisation-new-treatment-phenylketonuria-rare-inherited-metabolic-disease_en.pdf"},
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    {"id":"43999","name":"Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-03-08T15:36:00Z","last_updated_date":"2019-03-08T15:36:00Z","reference_number":"EMA/CHMP/CVMP/QWP/850374/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-sterilisation-medicinal-product-active-substance-excipient-and-primary-container_en.pdf"},
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    {"id":"44002","name":"EU/3/18/2112: Public summary of opinion on orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-03-11T09:24:00Z","last_updated_date":"2022-02-07T08:45:00Z","reference_number":"EMA/838048/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182112-public-summary-opinion-orphan-designation-bifunctional-fusion-protein-composed-two-extracellular-domains-transforming-growth-factor-beta-receptor-ii-fused-human-immunoglobulin-g1-monoclonal_en.pdf"},
    {"id":"44003","name":"EU/3/18/2111: Public summary of opinion on orphan designation: Allogeneic ABCB5-positive limbal stem cells for the treatment of limbal stem cell deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-03-11T09:48:00Z","last_updated_date":"2019-03-11T09:48:00Z","reference_number":"EMA/833462/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182111-public-summary-opinion-orphan-designation-allogeneic-abcb5-positive-limbal-stem-cells-treatment-limbal-stem-cell-deficiency_en.pdf"},
    {"id":"44004","name":"EU/3/18/2104: Public summary of opinion on orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)) for treatment of C3 glomerulopathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-03-11T10:07:00Z","last_updated_date":"2019-03-11T10:07:00Z","reference_number":"EMA/830788/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182104-public-summary-opinion-orphan-designation-4-2s4s-4-ethoxy-1-5-methoxy-7-methyl-1h-indol-4-ylmethylpiperidin-2-ylbenzoic-acid-hydrogen-chloride11-treatment-c3-glomerulopathy_en.pdf"},
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    {"id":"44086","name":"European authorities working to avoid shortages of medicines due to Brexit – Questions and answers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-03-26T12:00:00Z","last_updated_date":"2020-02-04T14:30:00Z","reference_number":"EMA/48159/2020 Rev 4","document_url":"https://www.ema.europa.eu/en/documents/other/european-authorities-working-avoid-shortages-medicines-due-brexit-questions-and-answers_en.pdf"},
    {"id":"44087","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-22T14:30:00Z","last_updated_date":"2019-03-22T14:30:00Z","reference_number":"EMA/CVMP/164241/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-19-21-march-2019_en.pdf"},
    {"id":"44088","name":"EMA Management Board: highlights of March 2019 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-22T14:31:00Z","last_updated_date":"2019-03-22T14:31:00Z","reference_number":"EMA/175734/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-march-2019-meeting_en.pdf"},
    {"id":"44089","name":"CVMP summary of positive opinion for Afoxolaner Merial","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-22T15:31:00Z","last_updated_date":"2019-03-22T15:31:00Z","reference_number":"EMA/CVMP/149492/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-afoxolaner-merial_en.pdf"},
    {"id":"44090","name":"CVMP summary of positive opinion for Baycox Iron","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-22T15:37:00Z","last_updated_date":"2019-03-22T15:37:00Z","reference_number":"EMA/CVMP/98703/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-baycox-iron_en.pdf"},
    {"id":"44091","name":"CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (X-001)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-22T15:42:00Z","last_updated_date":"2019-03-22T15:42:00Z","reference_number":"EMA/CVMP/153784/201","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-innovax-nd-ibd-x-001_en.pdf"},
    {"id":"44092","name":"CVMP post-authorisation summary of positive opinion for ProZinc (II-0015)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-22T15:47:00Z","last_updated_date":"2019-03-22T15:47:00Z","reference_number":"EMA/CVMP/147691/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-prozinc-ii-0015_en.pdf"},
    {"id":"44093","name":"CVMP post-authorisation summary of positive opinion for Vectra 3D (II-0011)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-22T15:51:00Z","last_updated_date":"2019-03-22T15:51:00Z","reference_number":"EMA/CVMP/164096/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-vectra-3d-ii-0011_en.pdf"},
    {"id":"44094","name":"Minor use or minor species (MUMS)/limited market scheme for veterinary medicinal products - 9th annual report (2018)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-03-22T15:18:00Z","last_updated_date":"2019-03-22T15:18:00Z","reference_number":"EMA/713390/2018","document_url":"https://www.ema.europa.eu/en/documents/report/minor-use-or-minor-species-mumslimited-market-scheme-veterinary-medicinal-products-9th-annual-report-2018_en.pdf"},
    {"id":"44095","name":"Decision on amending budget No 1-2019","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-03-22T16:20:00Z","last_updated_date":"2019-03-22T16:20:00Z","reference_number":"EMA/MB/171445/20199","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-1-2019_en.pdf"},
    {"id":"44097","name":"Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2019","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-03-22T16:33:00Z","last_updated_date":"2019-03-22T16:33:00Z","reference_number":"EMA/MB/909612/2019","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/rules-implementation-council-regulation-ec-no-29795-fees-payable-european-medicines-agency-and-other-measures-revised-implementing-rules-fee-regulation-1-april-2019_en.pdf"},
    {"id":"44098","name":"Summary of transfers of appropriations in budget 2018 - Management Board meeting of 21 March 2019","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-03-22T16:35:00Z","last_updated_date":"2019-03-22T16:35:00Z","reference_number":"EMA/MB/129665/2019","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2018-management-board-meeting-21-march-2019_en.pdf"},
    {"id":"44100","name":"Agenda - CAT agenda of the 20-22 March 2019 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2019-03-25T09:57:00Z","last_updated_date":"2019-03-25T09:57:00Z","reference_number":"EMA/CAT/191544/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-20-22-march-2019-meeting_en.pdf"},
    {"id":"44102","name":"PRAC work plan 2020","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2020-03-11T15:30:00Z","last_updated_date":"2020-03-11T15:30:00Z","reference_number":"EMA/PRAC/131664/2020 ","document_url":"https://www.ema.europa.eu/en/documents/work-programme/prac-work-plan-2020_en.pdf"},
    {"id":"44106","name":"Paracetamol / tramadol: List of nationally authorised medicinal products - PSUSA/00002310/201808","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-03-26T15:15:00Z","last_updated_date":"2019-03-26T15:15:00Z","reference_number":"EMA/193293/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-tramadol-list-nationally-authorised-medicinal-products-psusa00002310201808_en.pdf"},
    {"id":"44107","name":"Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201808","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-03-26T15:15:00Z","last_updated_date":"2019-03-26T15:15:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-sulphate-sodium-sulphate-potassium-sulphate-list-nationally-authorised-medicinal-products-psusa00010239201808_en.pdf"},
    {"id":"44108","name":"Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201808","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-03-26T15:15:00Z","last_updated_date":"2019-03-26T15:15:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/landiolol-list-nationally-authorised-medicinal-products-psusa00010570201808_en.pdf"},
    {"id":"44111","name":"Scientific advice and protocol assistance adopted at the CHMP meeting of 10–13 December 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2019-03-26T16:41:00Z","last_updated_date":"2019-03-26T16:41:00Z","reference_number":"EMA/CHMP/SAWP/876120/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-chmp-meeting-10-13-december-2018_en.pdf"},
    {"id":"44112","name":"Scientific advice and protocol assistance adopted at the CHMP meeting of 15-18 October 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2019-03-26T16:46:00Z","last_updated_date":"2019-03-26T16:46:00Z","reference_number":"EMA/CHMP/SAWP/742101/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-chmp-meeting-15-18-october-2018_en.pdf"},
    {"id":"44113","name":"Scientific advice and protocol assistance adopted at the CHMP meeting of 23 – 26 July 2018","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2019-03-26T16:51:00Z","last_updated_date":"2019-03-26T16:51:00Z","reference_number":"EMA/CHMP/SAWP/517642/2018","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-chmp-meeting-23-26-july-2018_en.pdf"},
    {"id":"44115","name":"2018 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission - Reporting period: 1 January to 31 December 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T10:12:00Z","last_updated_date":"2019-03-27T10:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/2018-annual-report-eudravigilance-european-parliament-council-and-commission-reporting-period-1-january-31-december-2018_en.pdf"},
    {"id":"44117","name":"EU/3/18/2126: Public summary of opinion on orphan designation: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment for the treatment of short bowel syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T14:51:00Z","last_updated_date":"2019-03-27T14:51:00Z","reference_number":"EMADOC-628903358-224","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182126-public-summary-opinion-orphan-designation-human-glucagon-peptide-2-analogue-linked-human-immunoglobulin-fc-fragment-treatment-short-bowel-syndrome_en.pdf"},
    {"id":"44118","name":"EU/3/18/2125: Public summary of opinion on orphan designation: Benserazide hydrochloride for treatment of sickle cell disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T15:06:00Z","last_updated_date":"2019-03-27T15:06:00Z","reference_number":"EMADOC-628903358-223","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182125-public-summary-opinion-orphan-designation-benserazide-hydrochloride-treatment-sickle-cell-disease_en.pdf"},
    {"id":"44119","name":"EU/3/18/2124: Public summary of opinion on orphan designation: Acetylleucine for treatment of ataxia telangiectasia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T15:22:00Z","last_updated_date":"2019-03-27T15:22:00Z","reference_number":"EMADOC-628903358-222","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182124-public-summary-opinion-orphan-designation-acetylleucine-treatment-ataxia-telangiectasia_en.pdf"},
    {"id":"44120","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-03-29T14:00:00Z","last_updated_date":"2019-03-29T14:00:00Z","reference_number":"EMA/CHMP/ICH/353369/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-q3d-elemental-impurities-step-5-revision-1_en.pdf"},
    {"id":"44121","name":"EU/3/18/2132: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues for the treatment of beta-thalas","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T15:40:00Z","last_updated_date":"2019-03-27T15:40:00Z","reference_number":"EMADOC-628903358-225","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182132-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-tmprss6-mrna-and-covalently-linked-ligand-containing-three-n-acetylgalactosamine_en.pdf"},
    {"id":"44122","name":"EU/3/18/2127: Public summary of opinion on orphan designation: Melatonin for the treatment of perinatal asphyxia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T15:50:00Z","last_updated_date":"2019-03-27T15:50:00Z","reference_number":"EMADOC-628903358-228","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182127-public-summary-opinion-orphan-designation-melatonin-treatment-perinatal-asphyxia_en.pdf"},
    {"id":"44123","name":"Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T16:00:00Z","last_updated_date":"2019-03-27T16:00:00Z","reference_number":"EMA/196332/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/poliovirus-type-1-poliovirus-type-3-oral-live-attenuated-vaccine-list-nationally-authorised-medicinal-products-psusa00010339201807_en.pdf"},
    {"id":"44124","name":"20 years of sampling and testing of centrally authorised products: 1998 – 2017","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-03-28T10:28:00Z","last_updated_date":"2019-03-28T10:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/20-years-sampling-and-testing-centrally-authorised-products-1998-2017_en.pdf"},
    {"id":"44125","name":"EU/3/18/2133: Public summary of opinion on orphan designation: Vinorelbine tartrate for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T16:42:00Z","last_updated_date":"2019-03-27T16:42:00Z","reference_number":"EMADOC-628903358-229","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182133-public-summary-opinion-orphan-designation-vinorelbine-tartrate-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"44126","name":"EU/3/18/2131: Public summary of opinion on orphan designation: Rozanolixizumab for the treatment of immune thrombocytopenia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T16:50:00Z","last_updated_date":"2023-05-08T10:05:00Z","reference_number":"EMADOC-628903358-230","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182131-public-summary-opinion-orphan-designation-rozanolixizumab-treatment-immune-thrombocytopenia_en.pdf"},
    {"id":"44127","name":"EU/3/18/2130: Public summary of opinion on orphan designation: Ralinepag for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T17:05:00Z","last_updated_date":"2019-03-27T17:05:00Z","reference_number":"EMADOC-628903358-231","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182130-public-summary-opinion-orphan-designation-ralinepag-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"44128","name":"EU/3/18/2129: Public summary of opinion on orphan designation: Miglustat for the treatment of glycogen storage disease type II (Pompe's disease)","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T17:22:00Z","last_updated_date":"2023-03-24T13:54:00Z","reference_number":"EMADOC-628903358-232","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182129-public-summary-opinion-orphan-designation-miglustat-treatment-glycogen-storage-disease-type-ii-pompes-disease_en.pdf"},
    {"id":"44129","name":"EU/3/18/2128: Public summary of opinion on orphan designation: Mercaptamine-pantetheine disulfide for the treatment of Rett syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2019-03-27T17:40:00Z","last_updated_date":"2019-03-27T17:40:00Z","reference_number":"EMADOC-628903358-233","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3182128-public-summary-opinion-orphan-designation-mercaptamine-pantetheine-disulfide-treatment-rett-syndrome_en.pdf"},
    {"id":"44131","name":"Metamizole Article-31 referral - CHMP assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2019-03-28T13:10:00Z","last_updated_date":"2019-03-28T13:10:00Z","reference_number":"EMA/143912/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-chmp-assessment-report_en.pdf"},
    {"id":"44132","name":"Metamizole Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-03-28T13:24:00Z","last_updated_date":"2019-03-28T13:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/metamizole-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/metamizole-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/metamizole-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/metamizole-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/metamizole-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/metamizole-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/metamizole-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/metamizole-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/metamizole-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/metamizole-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/metamizole-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/metamizole-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/metamizole-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/metamizole-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/metamizole-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/metamizole-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/metamizole-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/metamizole-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/metamizole-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/metamizole-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/metamizole-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/metamizole-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"44133","name":"CHMP post-authorisation summary of positive opinion for Revlimid (II-102-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-29T12:07:00Z","last_updated_date":"2019-03-29T12:07:00Z","reference_number":"EMA/CHMP/195079/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revlimid-ii-102-g_en.pdf"},
    {"id":"44134","name":"CHMP summary of positive opinion for Zynteglo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-03-29T14:30:00Z","last_updated_date":"2019-03-29T14:30:00Z","reference_number":"EMA/CHMP/166977/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zynteglo_en.pdf"},
    {"id":"44135","name":"CHMP post-authorisation summary of positive opinion for Imnovid (II-31-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-29T14:35:00Z","last_updated_date":"2019-03-29T14:35:00Z","reference_number":"EMA/CHMP/177804/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imnovid-ii-31-g_en.pdf"},
    {"id":"44137","name":"CHMP post-authorisation summary of positive opinion for Mozobil (II-34)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-03-29T15:49:00Z","last_updated_date":"2019-03-29T15:49:00Z","reference_number":"EMA/CHMP/198032/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mozobil-ii-34_en.pdf"},
    {"id":"44142","name":"Public statement on Silgard: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2019-04-02T09:32:00Z","last_updated_date":"2019-04-02T09:32:00Z","reference_number":"EMA/149281/2019","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-silgard-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"44143","name":"EMA confirms omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-03-29T12:00:00Z","last_updated_date":"2019-03-29T12:00:00Z","reference_number":"EMA/186168/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-confirms-omega-3-fatty-acid-medicines-are-not-effective-preventing-further-heart-problems-after-heart-attack_en.pdf"},
    {"id":"44146","name":"Basiron AC Article-13 referral - Questions and answers on Basiron AC and associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-03-29T12:00:00Z","last_updated_date":"2019-03-29T12:00:00Z","reference_number":"EMA/193962/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/basiron-ac-article-13-referral-questions-and-answers-basiron-ac-and-associated-names_en.pdf"},
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    {"id":"44159","name":"Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2019/2020","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-04-01T14:00:00Z","last_updated_date":"2019-05-20T12:30:00Z","reference_number":"EMA/CHMP/BWP/266098/2019","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/biologics-working-party-bwp-ad-hoc-influenza-working-group-amended-european-union-recommendations-seasonal-influenza-vaccine-composition-season-20192020_en.pdf"},
    {"id":"44160","name":"CHMP ORGAM agenda for the meeting on 18 February 2019","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2019-04-01T15:32:00Z","last_updated_date":"2019-04-01T15:32:00Z","reference_number":"EMA/CHMP/203261/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-18-february-2019_en.pdf"},
    {"id":"44163","name":"Withdrawal letter : Equitend","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2019-04-01T18:40:00Z","last_updated_date":"2019-04-01T18:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-equitend_en.pdf"},
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    {"id":"44166","name":"VICH GL57 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-04-03T14:07:00Z","last_updated_date":"2019-04-03T14:07:00Z","reference_number":"EMA/CVMP/VICH/517152/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl57-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-species-marker-residue-depletion-studies-establish-product-withdrawal-periods-aquatic-species_en.pdf"},
    {"id":"44167","name":"VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-04-03T15:36:00Z","last_updated_date":"2019-04-03T15:36:00Z","reference_number":"EMA/CVMP/VICH/467/2003","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl36r2-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-microbiological-adi-revision-2_en.pdf"},
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    {"id":"44187","name":"Agenda - PRAC draft agenda of meeting 8-11 April 2019","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2019-04-08T17:30:00Z","last_updated_date":"2019-04-08T17:30:00Z","reference_number":"EMA/PRAC/219089/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-8-11-april-2019_en.pdf"},
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    {"id":"44192","name":"EU/3/19/2140: Public summary of opinion on orphan designation for humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase for the treatment of mucopolysaccharidosis type II (Hunter’s syndrome)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-04-09T10:36:00Z","last_updated_date":"2019-04-09T10:36:00Z","reference_number":"EMADOC-628903358-444","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192140-public-summary-opinion-orphan-designation-humanised-igg1-monoclonal-antibody-targeting-human-transferrin-receptor-conjugated-human-iduronate-2-sulfatase-treatment-mucopolysaccharidosis-type_en.pdf"},
    {"id":"44194","name":"EU/3/19/2134: Public summary of opinion on orphan designation for 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester for the treatment of infantile neuroaxonal dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-04-09T11:15:00Z","last_updated_date":"2019-04-09T11:15:00Z","reference_number":"EMADOC-628903358-447","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192134-public-summary-opinion-orphan-designation-9-cis-12-cis-1111-d2-linoleic-acid-ethyl-ester-treatment-infantile-neuroaxonal-dystrophy_en.pdf"},
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    {"id":"44232","name":"Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - New review of risks with high-strength estradiol-containing creams","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-04-12T10:27:00Z","last_updated_date":"2019-04-12T10:27:00Z","reference_number":"EMA/215459/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/estradiol-containing-001-ww-medicinal-products-topical-use-article-31-referral-new-review-risks-high-strength-estradiol-containing-creams_en.pdf"},
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    {"id":"44321","name":"Mallow leaf: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2019-04-23T15:19:00Z","last_updated_date":"2019-04-23T15:19:00Z","reference_number":"EMA/834778/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/mallow-leaf-summary-public_en.pdf"},
    {"id":"44324","name":"Lynparza: warning that new tablets are used at different doses to the capsules","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2019-04-23T17:14:00Z","last_updated_date":"2019-04-23T17:14:00Z","reference_number":"EMA/107399/2018","document_url":"https://www.ema.europa.eu/en/documents/medication-error/lynparza-warning-new-tablets-are-used-different-doses-capsules_en.pdf"},
    {"id":"44326","name":"Superseded Community herbal monograph on Salix [various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.], cortex","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2009-09-26T10:12:00Z","last_updated_date":"2019-04-24T11:15:00Z","reference_number":"EMEA/HMPC/295338/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-cortex_en.pdf-0"},
    {"id":"44327","name":"Addendum to Assessment report on Potentialla erecta (L.) Raeusch., rhizoma - First review","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2019-04-24T10:53:00Z","last_updated_date":"2019-04-24T10:53:00Z","reference_number":"EMA/HMPC/554898/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-potentialla-erecta-l-raeusch-rhizoma-first-review_en.pdf"},
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    {"id":"44347","name":"Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00000986/201809","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-04-25T14:55:00Z","last_updated_date":"2019-04-25T14:55:00Z","reference_number":"EMA/218030/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexamfetamine-list-nationally-authorised-medicinal-products-psusa00000986201809_en.pdf"},
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    {"id":"44356","name":"CHMP summary of positive opinion for Xromi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-04-26T15:11:00Z","last_updated_date":"2019-04-26T15:11:00Z","reference_number":"EMA/CHMP/223395/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xromi_en.pdf"},
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    {"id":"44360","name":"EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-04-26T14:43:00Z","last_updated_date":"2019-04-30T12:51:00Z","reference_number":"EMA/237662/2019 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommends-withdrawal-marketing-authorisation-cancer-medicine-lartruvo_en.pdf"},
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    {"id":"44379","name":"New long-lasting implant to treat opioid dependence","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-04-26T14:49:00Z","last_updated_date":"2019-04-26T14:49:00Z","reference_number":"EMA/CHMP/240446/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-long-lasting-implant-treat-opioid-dependence_en.pdf"},
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    {"id":"44421","name":"Final assessment report on Ruscus aculeatus L. rhizoma - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2019-05-02T17:42:00Z","last_updated_date":"2019-05-02T17:42:00Z","reference_number":"EMA/HMPC/188805/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-ruscus-aculeatus-l-rhizoma-revision-1_en.pdf"},
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    {"id":"44423","name":"Overview of comments received on European Union herbal monograph on Ruscus aculeatus L., rhizoma (EMA/HMPC/188804/2017) - Revision 1","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2019-05-02T17:46:00Z","last_updated_date":"2019-05-02T17:46:00Z","reference_number":"EMA/HMPC/573003/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-ruscus-aculeatus-l-rhizoma-emahmpc1888042017-revision-1_en.pdf"},
    {"id":"44425","name":"Annex 10 – 2018 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2019-05-03T15:24:00Z","last_updated_date":"2019-09-19T09:39:00Z","reference_number":"EMA/848994/2019 Corr.2","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annex-10-2018-annual-report-european-medicines-agency-chmp-opinions-initial-evaluations-and-extensions-therapeutic-indication_en.xlsx"},
    {"id":"44426","name":"2018 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2019-05-03T16:54:00Z","last_updated_date":"2019-05-20T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/2018-annual-report-european-medicines-agency_en.pdf"},
    {"id":"44427","name":"Annexes - 2018 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2019-05-03T16:11:00Z","last_updated_date":"2019-05-03T16:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annexes-2018-annual-report-european-medicines-agency_en.pdf"},
    {"id":"44429","name":"Agenda - Substance, Product, Organisation and Referential data (SPOR) Task Force meeting (Dec 2018)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-05-06T10:43:00Z","last_updated_date":"2019-05-06T10:43:00Z","reference_number":"EMA/790603/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-substance-product-organisation-and-referential-data-spor-task-force-meeting-dec-2018_en.pdf"},
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    {"id":"44431","name":"Presentation - Target Operating Model update to SPOR task force","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-05-06T10:51:00Z","last_updated_date":"2019-05-06T10:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-target-operating-model-update-spor-task-force_en.pdf"},
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    {"id":"44433","name":"Presentation - New veterinary regulation: impact on IT/Telematics","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-05-06T10:56:00Z","last_updated_date":"2019-05-06T10:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-veterinary-regulation-impact-ittelematics_en.pdf"},
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    {"id":"44448","name":"Withdrawal assessment report for Canakinumab Novartis","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2019-05-07T11:15:00Z","last_updated_date":"2019-05-07T11:15:00Z","reference_number":"EMA/241276/2019","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-canakinumab-novartis_en.pdf"},
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    {"id":"44450","name":"EU/3/19/2149: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype rh10 containing the human cholesterol 24-hydroxylase gene for the treatment of Huntington's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-05-07T12:58:00Z","last_updated_date":"2019-05-07T12:58:00Z","reference_number":"EMADOC-628903358-641","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192149-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-rh10-containing-human-cholesterol-24-hydroxylase-gene-treatment-huntingtons-disease_en.pdf"},
    {"id":"44451","name":"EU/3/19/2151: Public summary of opinion on orphan designation: Marzeptacog alfa (activated) for the treatment of haemophilia B","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-05-07T14:57:00Z","last_updated_date":"2019-05-07T14:57:00Z","reference_number":"EMADOC-628903358-643","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192151-public-summary-opinion-orphan-designation-marzeptacog-alfa-activated-treatment-haemophilia-b_en.pdf"},
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    {"id":"44604","name":"CHMP summary of positive opinion for Posaconazole AHCL","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-05-29T19:00:00Z","last_updated_date":"2019-05-29T19:00:00Z","reference_number":"EMA/CHMP/275501/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-posaconazole-ahcl_en.pdf"},
    {"id":"44607","name":"CHMP summary of positive opinion for Cufence","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-05-29T10:32:00Z","last_updated_date":"2019-05-29T10:32:00Z","reference_number":"EMA/290870/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cufence_en.pdf"},
    {"id":"44608","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 23-26 April 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T10:34:00Z","last_updated_date":"2019-05-29T10:34:00Z","reference_number":"EMEA/PDCO/251835/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-23-26-april-2019_en.pdf"},
    {"id":"44610","name":"COMP meeting report on the review of applications for orphan designation: May 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T10:58:00Z","last_updated_date":"2019-05-29T10:58:00Z","reference_number":"EMA/COMP/202458/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-may-2019_en.pdf"},
    {"id":"44611","name":"Qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2019-05-29T11:15:00Z","last_updated_date":"2019-05-29T11:15:00Z","reference_number":"EMA/CHMP/SAWP/178058/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/qualification-opinion-stride-velocity-95th-centile-secondary-endpoint-duchenne-muscular-dystrophy-measured-valid-and-suitable-wearable-device_en.pdf"},
    {"id":"44612","name":"Overview of comments on 'Stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device' (EMA/532515/2018)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T11:15:00Z","last_updated_date":"2019-05-29T11:15:00Z","reference_number":"EMA/178057/2019","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-stride-velocity-95th-centile-secondary-endpoint-duchenne-muscular-dystrophy-measured-valid-and-suitable-wearable-device-ema5325152018_en.pdf"},
    {"id":"44619","name":"Withdrawal letter: Radicava","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T19:05:00Z","last_updated_date":"2019-05-29T19:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-radicava_en.pdf"},
    {"id":"44620","name":"CHMP summary of positive opinion for LysaKare","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-05-29T14:39:00Z","last_updated_date":"2019-05-29T14:39:00Z","reference_number":"EMA/CHMP/276812/2019 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lysakare_en.pdf"},
    {"id":"44621","name":"Questions and answers on the withdrawal of the marketing authorisation application for Radicava (edaravone)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T19:00:00Z","last_updated_date":"2019-05-29T19:00:00Z","reference_number":"EMA/293450/2019","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-application-radicava-edaravone_sv.pdf"}},
    {"id":"44622","name":"Start of Union reviews adopted during the CHMP meeting of 27-29 May 2019","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2019-05-29T15:55:00Z","last_updated_date":"2019-05-29T15:55:00Z","reference_number":"EMA/287458/2019","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-union-reviews-adopted-during-chmp-meeting-27-29-may-2019_en.pdf"},
    {"id":"44623","name":"Questions and answers on the refusal of the marketing authorisation for Xyndari (glutamine)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-05-29T19:00:00Z","last_updated_date":"2019-06-28T12:03:00Z","reference_number":"EMA/290531/2019 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-xyndari-glutamine_en.pdf"},
    {"id":"44624","name":"Fenspiride containing medicinal products Article-107i referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T16:45:00Z","last_updated_date":"2019-05-29T16:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/fenspiride-containing-medicinal-products-article-107i-referral-annex-iii_sv.pdf"}},
    {"id":"44625","name":"Withdrawal of marketing authorisations for fenspiride medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T16:45:00Z","last_updated_date":"2019-05-29T16:45:00Z","reference_number":"EMA/285298/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/withdrawal-marketing-authorisations-fenspiride-medicines_en.pdf-0"},
    {"id":"44626","name":"Methocarbamol / paracetamol Article 31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T18:08:00Z","last_updated_date":"2019-05-29T18:08:00Z","reference_number":"EMA/271110/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/methocarbamol-paracetamol-article-31-referral-review-started_en.pdf"},
    {"id":"44627","name":"Methocarbamol / paracetamol Article 31 referral - CHMP list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T18:15:00Z","last_updated_date":"2019-05-29T18:15:00Z","reference_number":"EMA/CHMP/285881/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/methocarbamol-paracetamol-article-31-referral-chmp-list-questions_en.pdf"},
    {"id":"44628","name":"Methocarbamol / paracetamol Article 31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T18:17:00Z","last_updated_date":"2019-12-17T15:55:00Z","reference_number":"EMA/CHMP/285880/2019 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/methocarbamol-paracetamol-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"44629","name":"Methocarbamol / paracetamol Article 31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T18:18:00Z","last_updated_date":"2020-06-17T01:14:00Z","reference_number":"EMA/298855/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-i_sv.pdf"}},
    {"id":"44630","name":"Methocarbamol / paracetamol Article 31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T18:21:00Z","last_updated_date":"2019-05-29T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methocarbamol-paracetamol-article-31-referral-notification_en.pdf"},
    {"id":"44631","name":"Mirtazapine: List of nationally authorised medicinal products - PSUSA/00002068/201808","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-05-30T11:49:00Z","last_updated_date":"2019-05-30T11:49:00Z","reference_number":"EMA/296287/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/mirtazapine-list-nationally-authorised-medicinal-products-psusa00002068201808_en.pdf"},
    {"id":"44640","name":"Syner-Kinase Article 29(4) referral - EMA recommends authorisation of Syner-Kinase (urokinase) in the EU","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2019-03-01T16:43:00Z","last_updated_date":"2019-06-03T16:51:00Z","reference_number":"EMA/299749/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/syner-kinase-article-294-referral-ema-recommends-authorisation-syner-kinase-urokinase-eu_sv.pdf"}},
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    {"id":"45229","name":"What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2019-08-09T16:28:00Z","last_updated_date":"2019-08-09T16:28:00Z","reference_number":"Issue 1 - 2019","document_url":"https://www.ema.europa.eu/en/documents/newsletter/whats-new-pharmacovigilance-qppv-update-issue-1-2019_en.pdf"},
    {"id":"45231","name":"CHMP ORGAM agenda for the meeting on 15 April 2019","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2019-08-12T09:17:00Z","last_updated_date":"2019-08-12T09:17:00Z","reference_number":"EMA/CHMP/447251/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-15-april-2019_en.pdf"},
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    {"id":"45235","name":"EU/3/19/2166: Public summary of opinion on orphan designation: Sodium benzoate, sodium phenylacetate for the treatment of carbamoyl-phosphate synthase-1 deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-08-12T15:25:00Z","last_updated_date":"2019-08-12T15:25:00Z","reference_number":"EMADOC-628903358-940","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192166-public-summary-opinion-orphan-designation-sodium-benzoate-sodium-phenylacetate-treatment-carbamoyl-phosphate-synthase-1-deficiency_en.pdf"},
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    {"id":"45248","name":"Human medicines highlights - August 2019","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2019-08-13T17:41:00Z","last_updated_date":"2019-08-13T17:41:00Z","reference_number":"Issue 125","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-august-2019_en.pdf"},
    {"id":"45255","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-08-14T14:32:00Z","last_updated_date":"2019-08-14T14:32:00Z","reference_number":"EMA/412788/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-june-2019_en.pdf"},
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    {"id":"45270","name":"COMP meeting report on the review of applications for orphan designation: April 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-08-19T13:56:00Z","last_updated_date":"2019-08-19T13:56:00Z","reference_number":"EMA/COMP/202458/2019 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-april-2019_en.pdf"},
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    {"id":"45453","name":"Bisoprolol / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000420/201811","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-09-13T16:52:00Z","last_updated_date":"2019-09-13T16:52:00Z","reference_number":"EMA/474202/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/bisoprolol-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00000420201811_en.pdf"},
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    {"id":"45516","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 August 2019 written procedure","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-09-24T15:24:00Z","last_updated_date":"2019-09-24T15:24:00Z","reference_number":"EMEA/PDCO/481535/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-20-23-august-2019-written-procedure_en.pdf"},
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    {"id":"45527","name":"EMA advises companies on steps to take to avoid nitrosamines in human medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-09-26T17:21:00Z","last_updated_date":"2019-09-26T17:21:00Z","reference_number":"EMA/511347/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-advises-companies-steps-take-avoid-nitrosamines-human-medicines_en.pdf"},
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    {"id":"45541","name":"Agenda - PRAC draft agenda of meeting 30 September-3 October 2019","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2019-09-30T15:21:00Z","last_updated_date":"2019-09-30T15:21:00Z","reference_number":"EMA/PRAC/485716/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-30-september-3-october-2019_en.pdf"},
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    {"id":"45548","name":"EU/3/19/2168: Public summary of opinion on orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidine-3-yl)chroman-2-carboxamide hydrochloride for the treatment of maternally inherited diabetes and deafness","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-10-02T16:30:00Z","last_updated_date":"2019-10-02T16:30:00Z","reference_number":"EMADOC-628903358-1034","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192168-public-summary-opinion-orphan-designation-s-6-hydroxy-2578-tetramethyl-n-r-piperidine-3-ylchroman-2-carboxamide-hydrochloride-treatment-maternally-inherited-diabetes-and-deafness_en.pdf"},
    {"id":"45549","name":"EU/3/19/2169: Public summary of opinion on orphan designation: Reldesemtiv for the treatment of spinal muscular atrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-10-02T16:57:00Z","last_updated_date":"2019-10-02T16:57:00Z","reference_number":"EMADOC-628903358-1039","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192169-public-summary-opinion-orphan-designation-reldesemtiv-treatment-spinal-muscular-atrophy_en.pdf"},
    {"id":"45551","name":"EU/3/19/2170: Public summary of opinion on orphan designation: 2-(2-{[2-(1H-benzimidazol-2-yl)ethyl]amino}ethyl)-N-[(3-fluoropyridin-2-yl)methyl]-1,3-oxazole-4-carboxamide trihydrochloride for the treatment of beta-thalassaemia intermedia and major","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-10-02T17:11:00Z","last_updated_date":"2019-10-02T17:11:00Z","reference_number":"EMADOC-628903358-1042","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192170-public-summary-opinion-orphan-designation-2-2-2-1h-benzimidazol-2-ylethylaminoethyl-n-3-fluoropyridin-2-ylmethyl-13-oxazole-4-carboxamide-trihydrochloride-treatment-beta-thalassaemia_en.pdf"},
    {"id":"45558","name":"EU/3/19/2171: Public summary of opinion on orphan designation: 5'-cEtG-sp-cEt5MeU-sp-cEt5MeU-sp-dT-sp-dA-sp-dT-sp-dT-sp-dA-sp-dT-sp-dA-sp-dG-sp-dG-sp-dG-sp-cEt5MeC-sp-cEt5MeU-sp-cEt5MeU-3' for the treatment of centronuclear myopathies","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-10-03T13:12:00Z","last_updated_date":"2019-10-03T13:12:00Z","reference_number":"EMADOC-628903358-1035","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192171-public-summary-opinion-orphan-designation-5-cetg-sp-cet5meu-sp-cet5meu-sp-dt-sp-da-sp-dt-sp-dt-sp-da-sp-dt-sp-da-sp-dg-sp-dg-sp-dg-sp-cet5mec-sp-cet5meu-sp-cet5meu-3-treatment-centronuclear_en.pdf"},
    {"id":"45566","name":"Minutes of the European Medicines Agency/European network for Health Technology Assessment dialogue meeting - December 2018","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2019-10-08T10:32:00Z","last_updated_date":"2019-10-08T10:32:00Z","reference_number":"EMA/832382/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-dialogue-meeting-december-2018_en.pdf"},
    {"id":"45567","name":"Estradiol-containing (0.01% w/w) medicinal products for topical use Article 31 referral - Four-week limit for use of high-strength estradiol creams","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-10-04T10:41:00Z","last_updated_date":"2019-10-31T15:00:00Z","reference_number":"EMA/531250/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/estradiol-containing-001-ww-medicinal-products-topical-use-article-31-referral-four-week-limit-use-high-strength-estradiol-creams_en.pdf"},
    {"id":"45568","name":"Four-week limit for use of high-strength estradiol creams","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-10-04T10:52:00Z","last_updated_date":"2019-10-04T10:52:00Z","reference_number":"EMA/531250/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/four-week-limit-use-high-strength-estradiol-creams_en.pdf"},
    {"id":"45569","name":"PRAC statistics: October 2019","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-10-04T11:47:00Z","last_updated_date":"2019-10-04T11:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-october-2019_en.pdf"},
    {"id":"45570","name":"EMA Management Board: highlights of October 2019 meeting","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-10-04T12:53:00Z","last_updated_date":"2019-10-04T12:53:00Z","reference_number":"EMA/526099/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-management-board-highlights-october-2019-meeting_en.pdf"},
    {"id":"45572","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-10-04T15:40:00Z","last_updated_date":"2019-10-04T15:40:00Z","reference_number":"EMA/CAT/517590/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-september-2019_en.pdf"},
    {"id":"45574","name":"EU/3/19/2172: Public summary of opinion on orphan designation: Gaboxadol monohydrate for the treatment of Angelman syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2019-10-07T10:12:00Z","last_updated_date":"2019-10-07T10:12:00Z","reference_number":"EMADOC-628903358-1033","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192172-public-summary-opinion-orphan-designation-gaboxadol-monohydrate-treatment-angelman-syndrome_en.pdf"},
    {"id":"45575","name":"Human medicines highlights - October 2019","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2019-10-07T13:05:00Z","last_updated_date":"2019-10-07T13:05:00Z","reference_number":"Issue 127","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-october-2019_en.pdf"},
    {"id":"45576","name":"Public statement on DepoCyte: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2019-10-07T14:35:00Z","last_updated_date":"2019-10-07T14:35:00Z","reference_number":"EMA/916333/2019","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-depocyte-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"45577","name":"EU/3/19/2173: Public summary of opinion on orphan designation: Imidazolyl ethanamide pentandioic acid for the treatment of acute radiation syndrome","type":"orphan-review","status":"Adopted","consultation_date":"","first_published_date":"2019-10-07T14:53:00Z","last_updated_date":"2019-10-07T14:53:00Z","reference_number":"EMADOC-628903358-1036","document_url":"https://www.ema.europa.eu/en/documents/orphan-review/eu3192173-public-summary-opinion-orphan-designation-imidazolyl-ethanamide-pentandioic-acid-treatment-acute-radiation-syndrome_en.pdf"},
    {"id":"45580","name":"Agenda for the 105th meeting of the Management Board: 3 October 2019","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2019-10-02T16:36:00Z","last_updated_date":"2019-10-07T17:37:00Z","reference_number":"EMA/MB/414950/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-105th-meeting-management-board-3-october-2019_en.pdf"},
    {"id":"45582","name":"Charter of tasks and responsibilities of the Executive Director as authorising officer","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2019-10-07T17:39:00Z","last_updated_date":"2019-10-07T17:39:00Z","reference_number":"EMA/MB/414689/2019","document_url":"https://www.ema.europa.eu/en/documents/other/charter-tasks-and-responsibilities-executive-director-authorising-officer_en.pdf"},
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    {"id":"45585","name":"Summary of transfers of appropriations in budget 2019","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-10-07T18:02:00Z","last_updated_date":"2019-10-07T18:02:00Z","reference_number":"EMA/MB/447289/2019","document_url":"https://www.ema.europa.eu/en/documents/other/summary-transfers-appropriations-budget-2019_en.pdf"},
    {"id":"45586","name":"Minutes of the 104th meeting of the Management Board","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2019-10-07T18:07:00Z","last_updated_date":"2019-10-07T18:07:00Z","reference_number":"EMA/MB/335139/2019","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-104th-meeting-management-board_en.pdf"},
    {"id":"45588","name":"Ex ante publicity of a negotiated procedure : EMA/2019/35/ED – Executive driver services","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2019-10-08T12:16:00Z","last_updated_date":"2019-10-08T12:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema201935ed-executive-driver-services_en.pdf"},
    {"id":"45602","name":"List of participants - European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP) - September 2019","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T09:19:00Z","last_updated_date":"2019-10-09T09:19:00Z","reference_number":"EMA/377520/2019","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-ema-patients-and-consumers-working-party-meeting-pcwp-september-2019_en.pdf"},
    {"id":"45603","name":"Presentation - CIOMS \"Guidance on patient involvement in the development and safe use of medicines\" (F. Houÿez, EURORDIS and I. Moulon, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T09:20:00Z","last_updated_date":"2019-10-09T09:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cioms-guidance-patient-involvement-development-and-safe-use-medicines-f-houyez-eurordis-and-i-moulon-ema_en.pdf"},
    {"id":"45604","name":"List of participants - European Medicines Agency (EMA) Healthcare Professionals' Working Party (HCPWP) meeting - September 2019","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T09:28:00Z","last_updated_date":"2019-10-09T09:28:00Z","reference_number":"EMA/377520/2019","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-ema-healthcare-professionals-working-party-hcpwp-meeting-september-2019_en.pdf"},
    {"id":"45605","name":"Presentation - Drug regulation in the 2020s: Key roles to play by HCPs and Academia (G.Calvo Rojas, EACPT)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T09:31:00Z","last_updated_date":"2019-10-09T09:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-drug-regulation-2020s-key-roles-play-hcps-and-academia-gcalvo-rojas-eacpt_en.pdf"},
    {"id":"45606","name":"List of participants - European Medicines Agency (EMA) Joint Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) meeting - September 2019","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T09:38:00Z","last_updated_date":"2019-10-09T09:38:00Z","reference_number":"EMA/376430/2019","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-european-medicines-agency-ema-joint-patients-and-consumers-pcwp-and-healthcare-professionals-hcpwp-meeting-september-2019_en.pdf"},
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    {"id":"45621","name":"Amitriptyline hydrochloride / chlordiazepoxide: List of nationally authorised medicinal products - PSUSA/00000171/201902","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T10:42:00Z","last_updated_date":"2019-10-09T10:42:00Z","reference_number":"EMA/548242/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-hydrochloride-chlordiazepoxide-list-nationally-authorised-medicinal-products-psusa00000171201902_en.pdf"},
    {"id":"45622","name":"Ethanol-orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010416/201902","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T12:59:00Z","last_updated_date":"2019-10-09T12:59:00Z","reference_number":"EMA/542694/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethanol-orthophenylphenol-list-nationally-authorised-medicinal-products-psusa00010416201902_en.pdf"},
    {"id":"45623","name":"Octenidine dihydrochloride 1-propanol 2-propanol: List of nationally authorised medicinal products - PSUSA/00010417/201901","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T13:01:00Z","last_updated_date":"2019-10-09T13:01:00Z","reference_number":"EMA/542617/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/octenidine-dihydrochloride-1-propanol-2-propanol-list-nationally-authorised-medicinal-products-psusa00010417201901_en.pdf"},
    {"id":"45626","name":"Cilostazol: List of nationally authorised medicinal products - PSUSA/00010209/201902","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-10-09T14:07:00Z","last_updated_date":"2019-10-09T14:07:00Z","reference_number":"EMA/550753/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/cilostazol-list-nationally-authorised-medicinal-products-psusa00010209201902_en.pdf"},
    {"id":"45628","name":"Agenda - Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-10-04T15:35:00Z","last_updated_date":"2019-11-04T15:50:00Z","reference_number":"EMA/499786/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-role-registries-monitoring-cancer-therapies-based-genetic-and-molecular-features_en.pdf"},
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    {"id":"45945","name":"Influenza vaccine (surface antigen, inactivated, adjuvanted) : List of nationally authorised medicinal products - PSUSA/00010300/201903","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-11-08T14:20:00Z","last_updated_date":"2019-11-08T14:20:00Z","reference_number":"EMA/601121/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-adjuvanted-list-nationally-authorised-medicinal-products-psusa00010300201903_en.pdf"},
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    {"id":"45947","name":"Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/201903","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-11-08T14:20:00Z","last_updated_date":"2019-11-08T14:20:00Z","reference_number":"EMA/601087/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-prepared-cell-cultures-list-nationally-authorised-medicinal-products-psusa00010299201903_en.pdf"},
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    {"id":"45951","name":"Agenda - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-11-11T14:20:00Z","last_updated_date":"2019-11-26T10:00:00Z","reference_number":"EMA/557028/2019 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-annual-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"45952","name":"Responses to questions raised at the Bravecto petition hand over","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2019-11-08T15:29:00Z","last_updated_date":"2019-11-08T15:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/responses-questions-raised-bravecto-petition-hand-over_en.pdf"},
    {"id":"45953","name":"EMA Regulatory Science to 2025 - Five goals","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2019-11-11T14:20:00Z","last_updated_date":"2019-11-14T13:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/ema-regulatory-science-2025-five-goals_en.pdf"},
    {"id":"45955","name":"CHMP ORGAM agenda for the meeting on 7 October 2019","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2019-11-11T13:11:00Z","last_updated_date":"2019-11-11T13:11:00Z","reference_number":"EMA/CHMP/518388/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-7-october-2019_en.pdf"},
    {"id":"45956","name":"Agenda - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-11-11T14:20:00Z","last_updated_date":"2019-11-14T14:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-multi-stakeholder-workshop-draft-regulatory-science-2025-strategy-stakeholders-human-medicines_en.pdf"},
    {"id":"45957","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 15-18 October 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-11-11T14:08:00Z","last_updated_date":"2019-11-11T14:08:00Z","reference_number":"EMEA/582190/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-15-18-october-2019_en.pdf"},
    {"id":"45966","name":"Annual activity report 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-11-12T15:47:00Z","last_updated_date":"2019-11-12T15:47:00Z","reference_number":"EMA/112688/2019","document_url":"https://www.ema.europa.eu/en/documents/report/annual-activity-report-2018_en.pdf"},
    {"id":"45967","name":"Withdrawal letter: Luxceptar","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2019-11-15T16:06:00Z","last_updated_date":"2019-11-15T16:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-luxceptar_en.pdf"},
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    {"id":"46131","name":"Agenda - PRAC draft agenda of meeting 25-28 November 2019","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2019-11-25T16:19:00Z","last_updated_date":"2019-11-25T16:19:00Z","reference_number":"EMA/PRAC/640603/2019 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-25-28-november-2019_en.pdf"},
    {"id":"46132","name":"European Medicines Agency second response to European Ombudsman regarding pre-submission activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:00:00Z","last_updated_date":"2019-11-26T10:00:00Z","reference_number":"EMA/627113/2019","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-second-response-european-ombudsman-regarding-pre-submission-activities_en.pdf"},
    {"id":"46133","name":"List of participants  - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T09:57:00Z","last_updated_date":"2019-11-26T09:57:00Z","reference_number":"EMA/561005/2019","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-annual-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"46134","name":"Presentation - Addresssing future challenges and key priorities (Guido Rasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T09:59:00Z","last_updated_date":"2019-11-26T09:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-addresssing-future-challenges-and-key-priorities-guido-rasi_en.pdf"},
    {"id":"46135","name":"Presentation - EMA Regulatory Science to 2025 - Welcome","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-welcome_en.pdf"},
    {"id":"46136","name":"Presentation - 1.2 - From relocation towards a business recovery pathway (Noel Wathion)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:01:00Z","last_updated_date":"2019-11-26T10:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-12-relocation-towards-business-recovery-pathway-noel-wathion_en.pdf"},
    {"id":"46137","name":"Presentation - EMA Regulatory Science to 2025 - Overview of the outcome of the publication consultation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-overview-outcome-publication-consultation_en.pdf"},
    {"id":"46138","name":"Presentation - EMA Regulatory Science to 2025 - Support developments in precision medicine, biomarkers and ‘omics’","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-support-developments-precision-medicine-biomarkers-and-omics_en.pdf"},
    {"id":"46139","name":"Presentation - EMA Regulatory Science to 2025 - Support translation of advanced therapy medicinal products (ATMPs) into patient treatments","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-support-translation-advanced-therapy-medicinal-products-atmps-patient-treatments_en.pdf"},
    {"id":"46140","name":"Presentation : 1.3 - Move to the permanent premises (Tiago Freitas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:09:00Z","last_updated_date":"2019-11-26T10:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-13-move-permanent-premises-tiago-freitas_en.pdf"},
    {"id":"46141","name":"Presentation : 2.1 - New veterinary regulation (Jordi Torren Edo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:13:00Z","last_updated_date":"2019-11-26T10:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-21-new-veterinary-regulation-jordi-torren-edo_en.pdf"},
    {"id":"46143","name":"Presentation : 2.3 - Clinical trial regulation (Anabela Marcal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:21:00Z","last_updated_date":"2019-11-26T10:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-23-clinical-trial-regulation-anabela-marcal_en.pdf"},
    {"id":"46144","name":"Presentation - 3.1 - Findings from ECDC's survey on healthcare workers' knowledge and attitudes about antibiotics and antibiotics resistance (J. Kinsman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:27:00Z","last_updated_date":"2019-11-26T10:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-31-findings-ecdcs-survey-healthcare-workers-knowledge-and-attitudes-about-antibiotics-and-antibiotics-resistance-j-kinsman_en.pdf"},
    {"id":"46146","name":"Presentation - EMA Regulatory Science to 2025 - Diversify and integrate the provision of regulatory advice along the development continuum","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-diversify-and-integrate-provision-regulatory-advice-along-development-continuum_en.pdf"},
    {"id":"46147","name":"Presentation - EMA Regulatory Science to 2025 - Recommendations related to downstream decision making, HTA’s preparedness, and collaboration with payers","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-recommendations-related-downstream-decision-making-htas-preparedness-and-collaboration-payers_en.pdf"},
    {"id":"46148","name":"Presentation - EMA Regulatory Science to 2025 - Promote use of high-quality real-world data (RWD) in decision making","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-promote-use-high-quality-real-world-data-rwd-decision-making_en.pdf"},
    {"id":"46149","name":"Presentation - 3.2 - EMA communication campaign for European Antibiotic Awareness Day 2019 (Alessandro Faia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:31:00Z","last_updated_date":"2019-11-26T10:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-32-ema-communication-campaign-european-antibiotic-awareness-day-2019-alessandro-faia_en.pdf"},
    {"id":"46150","name":"Presentation - EMA Regulatory Science to 2025 - Foster innovation in clinical trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-foster-innovation-clinical-trials_en.pdf"},
    {"id":"46151","name":"Presentation - EMA Regulatory Science to 2025 - Develop the regulatory framework for emerging clinical data generation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-develop-regulatory-framework-emerging-clinical-data-generation_en.pdf"},
    {"id":"46152","name":"Presentation - EMA Regulatory Science to 2025 - Optimise capabilities in modelling, simulation and extrapolation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-optimise-capabilities-modelling-simulation-and-extrapolation_en.pdf"},
    {"id":"46153","name":"Presentation - EMA Regulatory Science to 2025 - Reinforce patient relevance in evidence generation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-reinforce-patient-relevance-evidence-generation_en.pdf"},
    {"id":"46154","name":"Presentation - EMA Regulatory Science to 2025 - Develop network-led partnerships with academia to undertake fundamental research in strategic areas of regulatory science","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-develop-network-led-partnerships-academia-undertake-fundamental-research-strategic-areas-regulatory-science_en.pdf"},
    {"id":"46155","name":"Presentation - EMA Regulatory Science to 2025 - Developing scientific advice/assessment pathways - Feedback from breakout session 3A","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-developing-scientific-adviceassessment-pathways-feedback-breakout-session-3a_en.pdf"},
    {"id":"46156","name":"Presentation : 4.1 - EMA training and training strategy (Maria Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:34:00Z","last_updated_date":"2019-11-26T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-41-ema-training-and-training-strategy-maria-mavris_en.pdf"},
    {"id":"46157","name":"Presentation - EMA Regulatory Science to 2025 - Optimising evidence incl. RWD for decision making and communication - Feedback from session 3B","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-optimising-evidence-incl-rwd-decision-making-and-communication-feedback-session-3b_en.pdf"},
    {"id":"46158","name":"Presentation - EMA Regulatory Science to 2025 - Continue to support development of new antibacterial agents and their alternatives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-continue-support-development-new-antibacterial-agents-and-their-alternatives_en.pdf"},
    {"id":"46159","name":"Presentation - EMA Regulatory Science to 2025 - Reinforcing patient relevance in evidence generation - Feedback from breakout session 5C","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-reinforcing-patient-relevance-evidence-generation-feedback-breakout-session-5c_en.pdf"},
    {"id":"46160","name":"Presentation - EMA Regulatory Science to 2025 - Developing research partnerships with academia - Feedback from breakout session 5D","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-developing-research-partnerships-academia-feedback-breakout-session-5d_en.pdf"},
    {"id":"46161","name":"Presentation - EMA Regulatory Science to 2025 - Delivering the strategy","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-delivering-strategy_en.pdf"},
    {"id":"46162","name":"Presentation - EMA Regulatory Science to 2025 - Human Workshop - Draft briefing materials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-11-26T10:06:00Z","last_updated_date":"2019-11-26T10:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-science-2025-human-workshop-draft-briefing-materials_en.pdf"},
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    {"id":"46164","name":"Dashboard created for visual representation of the scoring of the included data sources","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-11-27T15:30:00Z","last_updated_date":"2019-11-27T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/dashboard-created-visual-representation-scoring-included-data-sources_en.xlsx"},
    {"id":"46165","name":"Inventory of registries","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-11-27T15:30:00Z","last_updated_date":"2019-11-27T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/inventory-registries_en.xlsx"},
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    {"id":"46231","name":"Addendum to assessment report on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2019-12-04T11:45:00Z","last_updated_date":"2019-12-04T11:45:00Z","reference_number":"EMA/HMPC/638015/2018 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-hamamelis-virginiana-l-folium-et-cortex-aut-ramunculus-destillatum_en.pdf"},
    {"id":"46239","name":"Addendum to assessment report on Potentialla erecta (L.) Raeusch., rhizoma","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2019-12-05T11:50:00Z","last_updated_date":"2019-12-05T11:50:00Z","reference_number":"EMA/HMPC/554898/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-potentialla-erecta-l-raeusch-rhizoma_en.pdf"},
    {"id":"46241","name":"Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201904","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T14:59:00Z","last_updated_date":"2019-12-05T14:59:00Z","reference_number":"EMA/664500/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-topical-use-list-nationally-authorised-medicinal-products-psusa00010376201904_en.pdf"},
    {"id":"46242","name":"Ivermectin (systemic use): List of nationally authorised medicinal products - PSUSA/00010377/201904","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T15:02:00Z","last_updated_date":"2019-12-05T15:02:00Z","reference_number":"EMA/664534/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/ivermectin-systemic-use-list-nationally-authorised-medicinal-products-psusa00010377201904_en.pdf"},
    {"id":"46243","name":"Presentation - Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features: Introduction from the chair (Peter Mol)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T15:03:00Z","last_updated_date":"2019-12-05T15:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-role-registries-monitoring-cancer-therapies-based-genetic-and-molecular-features-introduction-chair-peter-mol_en.pdf"},
    {"id":"46244","name":"Presentation - A regulatory view on the role of registries for generating data on cancer therapies (Filip Josephson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T15:10:00Z","last_updated_date":"2019-12-05T15:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-view-role-registries-generating-data-cancer-therapies-filip-josephson_en.pdf"},
    {"id":"46245","name":"Presentation - The European Network of Cancer Registries (ENCR) (Otto Visser)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T15:12:00Z","last_updated_date":"2019-12-05T15:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-cancer-registries-encr-otto-visser_en.pdf"},
    {"id":"46246","name":"Presentation - Registries for European Reference Networks (ERNs) (Hélène Le Borgne)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T15:14:00Z","last_updated_date":"2019-12-05T15:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-registries-european-reference-networks-erns-helene-le-borgne_en.pdf"},
    {"id":"46247","name":"Presentation - The National Cancer Registration and Analysis Service (NCRAS) England: Data collection for tumour agnostic treatments (Alice Turnbull)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T16:39:00Z","last_updated_date":"2019-12-05T16:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-national-cancer-registration-and-analysis-service-ncras-england-data-collection-tumour-agnostic-treatments-alice-turnbull_en.pdf"},
    {"id":"46248","name":"Agenda - CAT agenda of the 4-6 December 2019 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T16:48:00Z","last_updated_date":"2019-12-05T16:48:00Z","reference_number":"EMA/CAT/664648/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-4-6-december-2019-meeting_en.pdf"},
    {"id":"46249","name":"Open call for data on use of antimicrobials  in animals - questionaire","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2019-12-05T18:08:00Z","last_updated_date":"2019-12-05T18:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/open-call-data-use-antimicrobials-animals-questionaire_en.xlsx"},
    {"id":"46252","name":"EMA update on metformin diabetes medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-12-06T12:29:00Z","last_updated_date":"2019-12-06T12:29:00Z","reference_number":"EMA/660975/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-update-metformin-diabetes-medicines_en.pdf"},
    {"id":"46254","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 2019","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2019-12-06T16:00:00Z","last_updated_date":"2019-12-06T16:00:00Z","reference_number":"EMA/CVMP/629092/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-3-5-december-2019_en.pdf"},
    {"id":"46255","name":"CVMP post-authorisation summary of positive opinion for Eravac (II-0005-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-06T16:00:00Z","last_updated_date":"2019-12-06T16:00:00Z","reference_number":"EMA/CVMP/640568/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-eravac-ii-0005-g_en.pdf"},
    {"id":"46256","name":"CVMP post-authorisation summary of positive opinion for Onsior (II-0024-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-06T16:00:00Z","last_updated_date":"2019-12-06T16:00:00Z","reference_number":"EMA/CVMP/622008/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-onsior-ii-0024-g_en.pdf"},
    {"id":"46258","name":"Tormentillae rhizoma: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T11:14:00Z","last_updated_date":"2019-12-09T11:14:00Z","reference_number":"EMA/166412/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/tormentillae-rhizoma-summary-public_en.pdf"},
    {"id":"46259","name":"Addendum to assessment report on Hamamelis virginiana L., folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2019-12-09T13:43:00Z","last_updated_date":"2019-12-09T13:43:00Z","reference_number":"EMA/HMPC/637991/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-hamamelis-virginiana-l-folium_en.pdf"},
    {"id":"46261","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2019","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T15:24:00Z","last_updated_date":"2019-12-09T15:24:00Z","reference_number":"EMA/596031/2019","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-october-2019_en.pdf"},
    {"id":"46262","name":"Presentation - Session 1 - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for veterinary medicines): Overview of the outcome of the publication consultation (Ivo Claassen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T15:48:00Z","last_updated_date":"2019-12-09T15:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-multi-stakeholder-workshop-draft-regulatory-science-2025-strategy-stakeholders-veterinary-medicines-overview-outcome-publication-consultation-ivo-claassen_en.pdf"},
    {"id":"46263","name":"Presentation - Session 2 - Develop new approaches to improve the benefit-risk assessment of veterinary medicinal product: Underlying actions (David Murphy, Supported by Jordi Torren Edo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T15:57:00Z","last_updated_date":"2019-12-09T15:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-develop-new-approaches-improve-benefit-risk-assessment-veterinary-medicinal-product-underlying-actions-david-murphy-supported-jordi-torren-edo_en.pdf"},
    {"id":"46264","name":"Presentation - Session 3a - Continue to promote the responsible use of antimicrobials and their alternatives: Underlying actions (Christine Schwarz, Thomas Heberer, Helen Jukes, Javier Pozo Gonzalez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:00:00Z","last_updated_date":"2019-12-09T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3a-continue-promote-responsible-use-antimicrobials-and-their-alternatives-underlying-actions-christine-schwarz-thomas-heberer-helen-jukes-javier-pozo-gonzalez_en.pdf"},
    {"id":"46265","name":"Presentation - Session 3b - Reinforce and further embed application of the 3Rs principles (Raffaella Corvi , Ellen-Margrethe Vestergaard , Nicholas Jarrett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:02:00Z","last_updated_date":"2019-12-09T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3b-reinforce-and-further-embed-application-3rs-principles-raffaella-corvi-ellen-margrethe-vestergaard-nicholas-jarrett_en.pdf"},
    {"id":"46266","name":"Presentation - Session 4 - Collaborate with stakeholders to modernise veterinary pharmacoepidemiology and pharmacovigilance (Frank Verheijen, Gabriel Beechinor, Barbara Freischem)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:13:00Z","last_updated_date":"2019-12-09T16:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-collaborate-stakeholders-modernise-veterinary-pharmacoepidemiology-and-pharmacovigilance-frank-verheijen-gabriel-beechinor-barbara-freischem_en.pdf"},
    {"id":"46267","name":"Presentation - Session 5 - Promote and support development of veterinary vaccines (Esther Werner, Javier Pozo Gonzalez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:17:00Z","last_updated_date":"2019-12-09T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-promote-and-support-development-veterinary-vaccines-esther-werner-javier-pozo-gonzalez_en.pdf"},
    {"id":"46268","name":"Presentation - Session 6 - Feedback from session 3a: Continue to promote the responsible use of antimicrobials and their alternatives (Christine Schwarz, Thomas Heberer, Helen Jukes, Javier Pozo Gonzalez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:21:00Z","last_updated_date":"2019-12-09T16:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-6-feedback-session-3a-continue-promote-responsible-use-antimicrobials-and-their-alternatives-christine-schwarz-thomas-heberer-helen-jukes-javier-pozo-gonzalez_en.pdf"},
    {"id":"46269","name":"Presentation - Session 6 - Feedback from session 3b: Reinforce and further embed application of the 3Rs principles (Raffaella Corvi , Ellen-Margrethe Vestergaard , Nicholas Jarrett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:47:00Z","last_updated_date":"2019-12-09T16:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-6-feedback-session-3b-reinforce-and-further-embed-application-3rs-principles-raffaella-corvi-ellen-margrethe-vestergaard-nicholas-jarrett_en.pdf"},
    {"id":"46270","name":"Presentation - Session 7 - Transform the regulatory framework for innovative veterinary medicines (Jean Pierre Orand,  Ivo Claassen, Noemi Garcia del Blanco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T16:56:00Z","last_updated_date":"2019-12-09T16:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-7-transform-regulatory-framework-innovative-veterinary-medicines-jean-pierre-orand-ivo-claassen-noemi-garcia-del-blanco_en.pdf"},
    {"id":"46271","name":"Presentation - Session 8 - Delivering the strategy (Guido Rasi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2019-12-09T17:13:00Z","last_updated_date":"2019-12-09T17:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-8-delivering-strategy-guido-rasi_en.pdf"},
    {"id":"46278","name":"Human medicines highlights - December 2019","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2019-12-10T11:55:00Z","last_updated_date":"2019-12-10T11:55:00Z","reference_number":"Issue 129","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-december-2019_en.pdf"},
    {"id":"46283","name":"CHMP summary of positive opinion for Beovu","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T16:12:00Z","last_updated_date":"2019-12-13T16:12:00Z","reference_number":"EMA/CHMP/656078/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-beovu_en.pdf"},
    {"id":"46290","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-12-11T09:08:00Z","last_updated_date":"2019-12-11T09:08:00Z","reference_number":"EMA/659929/2019","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-chapter-piii-pharmacovigilance-use-medicines-pregnant-and-breastfeeding-women_en.pdf"},
    {"id":"46291","name":"Annual report 2018 on staff engaging in an occupational activity within two years of leaving the service (article 16 of the staff regulations)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2019-12-11T10:29:00Z","last_updated_date":"2019-12-11T10:29:00Z","reference_number":"EMA/131220/2019","document_url":"https://www.ema.europa.eu/en/documents/report/annual-report-2018-staff-engaging-occupational-activity-within-two-years-leaving-service-article-16-staff-regulations_en.pdf"},
    {"id":"46292","name":"CHMP post-authorisation summary of positive opinion for Erleada (II-01)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:00:00Z","last_updated_date":"2019-12-13T12:00:00Z","reference_number":"EMA/CHMP/672735/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-erleada-ii-01_en.pdf"},
    {"id":"46295","name":"Minutes of the 105th meeting of the Management Board: 3 October 2019","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2019-12-11T14:41:00Z","last_updated_date":"2019-12-11T14:41:00Z","reference_number":"EMA/MB/542228/2019","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-105th-meeting-management-board-3-october-2019_en.pdf"},
    {"id":"46298","name":"CHMP post-authorisation summary of positive opinion for Stelara (II-73)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:00:00Z","last_updated_date":"2019-12-13T12:00:00Z","reference_number":"EMA/CHMP/645416/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stelara-ii-73_en.pdf"},
    {"id":"46299","name":"CHMP summary of positive opinion for Amsparity","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:46:00Z","last_updated_date":"2019-12-13T12:46:00Z","reference_number":"EMA/CHMP/642336/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-amsparity_en.pdf"},
    {"id":"46300","name":"CHMP post-authorisation summary of positive opinion for Darzalex (II-30)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:52:00Z","last_updated_date":"2019-12-13T12:52:00Z","reference_number":"EMA/CHMP/598973/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-ii-30_en.pdf"},
    {"id":"46301","name":"CHMP post-authorisation summary of positive opinion for Sirturo (II-33-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:00:00Z","last_updated_date":"2019-12-13T12:00:00Z","reference_number":"EMA/CHMP/542462/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sirturo-ii-33-g_en.pdf"},
    {"id":"46302","name":"CHMP summary of positive opinion for Recarbrio","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:00:00Z","last_updated_date":"2019-12-13T12:00:00Z","reference_number":"EMA/CHMP/662007/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-recarbrio_en.pdf"},
    {"id":"46303","name":"CHMP post-authorisation summary of positive opinion for Dificlir (X-34)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T14:27:00Z","last_updated_date":"2019-12-13T14:27:00Z","reference_number":"EMA/CHMP/515208/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dificlir-x-34_en.pdf"},
    {"id":"46304","name":"CHMP summary of positive opinion for Dexmedetomidine Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T15:54:00Z","last_updated_date":"2019-12-13T15:54:00Z","reference_number":"EMA/CHMP/655997/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dexmedetomidine-accord_en.pdf"},
    {"id":"46312","name":"CHMP post-authorisation summary of positive opinion for Cyramza (II-33)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T09:45:00Z","last_updated_date":"2019-12-13T09:45:00Z","reference_number":"EMA/CHMP/676031/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cyramza-ii-33_en.pdf"},
    {"id":"46313","name":"CHMP post-authorisation summary of positive opinion for Akynzeo","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T09:53:00Z","last_updated_date":"2019-12-13T09:53:00Z","reference_number":"EMA/CHMP/670824/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-akynzeo_en.pdf"},
    {"id":"46314","name":"VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-12-13T10:00:00Z","last_updated_date":"2020-12-17T19:00:00Z","reference_number":"EMA/CVMP/VICH/335918/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl58-stability-testing-new-veterinary-drug-substances-and-medicinal-products-climatic-zones-iii-and-iv-first-version_en.pdf"},
    {"id":"46315","name":"CHMP summary of positive opinion for Azacitidine Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:00:00Z","last_updated_date":"2019-12-13T12:00:00Z","reference_number":"EMA/CHMP/595680/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-azacitidine-accord_en.pdf"},
    {"id":"46316","name":"Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-12-13T11:00:00Z","last_updated_date":"2019-12-13T11:00:00Z","reference_number":"EMA/CAT/499821/2019","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-comparability-considerations-advanced-therapy-medicinal-products-atmp_en.pdf"},
    {"id":"46317","name":"CHMP post-authorisation summary of positive opinion for Vyndaqel (X-49-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2019-12-13T12:00:00Z","last_updated_date":"2019-12-13T12:00:00Z","reference_number":"EMA/CHMP/649350/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vyndaqel-x-49-g_en.pdf"},
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    {"id":"46443","name":"EU/3/08/595: Public summary of positive opinion for orphan designation of monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for the treatment of peripheral T-cell lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-01-16T17:17:00Z","last_updated_date":"2020-01-16T17:17:00Z","reference_number":"EMADOC-628903358-1297","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu308595-public-summary-positive-opinion-orphan-designation-monoclonal-antibody-against-human-cd30-covalently-linked-cytotoxin-monomethylauristatin-e-brentuximab-vedotin-treatment-peripheral-t-cell_en.pdf-0"},
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    {"id":"46477","name":"EU/3/19/2205: Public summary of positive opinion for orphan designation of 2-(3-(4-(1H-Indazol-5-ylamino)quinazolin-2-yl)phenoxy)-N-isopropylacetamide-methane sulfonic acid salt for the treatment of graft-versus-host disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-21T16:42:00Z","last_updated_date":"2020-01-21T16:42:00Z","reference_number":"EMADOC-628903358-1520","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192205-public-summary-positive-opinion-orphan-designation-2-3-4-1h-indazol-5-ylaminoquinazolin-2-ylphenoxy-n-isopropylacetamide-methane-sulfonic-acid-salt-treatment-graft-versus-host-disease_en.pdf"},
    {"id":"46478","name":"EU/3/19/2206: Public summary of positive opinion for orphan designation of 2'-O-(2-Methoxyethyl)-d-ribose antisense oligonucleotide targeting glial fibrillary acidic protein messenger ribonucleic acid for the treatment of Alexander disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-21T16:59:00Z","last_updated_date":"2020-01-21T16:59:00Z","reference_number":"EMADOC-628903358-1522","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192206-public-summary-positive-opinion-orphan-designation-2-o-2-methoxyethyl-d-ribose-antisense-oligonucleotide-targeting-glial-fibrillary-acidic-protein-messenger-ribonucleic-acid-treatment_en.pdf"},
    {"id":"46479","name":"EU/3/19/2207: Public summary of positive opinion for orphan designation of 4-Oxo-4H-chromene-2-carboxylic acid (2-(2-4-(2-(6,7-dimethoxy-3,4-dihydro-1H-isoquinolin-2-yl)-ethyl)-(...) for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-21T17:11:00Z","last_updated_date":"2020-01-21T17:11:00Z","reference_number":"EMADOC-628903358-1511","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192207-public-summary-positive-opinion-orphan-designation-4-oxo-4h-chromene-2-carboxylic-acid-2-2-4-2-67-dimethoxy-34-dihydro-1h-isoquinolin-2-yl-ethyl-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"46480","name":"EU/3/19/2208: Public summary of positive opinion for orphan designation of combination of two adeno-associated viral vectors of serotype 8 containing the 5'- and the 3'- (...) of human ABCA4 fused to inteins for the treatment of Stargardt’s disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-22T10:14:00Z","last_updated_date":"2020-01-22T10:14:00Z","reference_number":"EMADOC-628903358-1519","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192208-public-summary-positive-opinion-orphan-designation-combination-two-adeno-associated-viral-vectors-serotype-8-containing-5-and-3-human-abca4-fused-inteins-treatment-stargardts-disease_en.pdf"},
    {"id":"46481","name":"EU/3/19/2209: Public summary of positive opinion for orphan designation of anti-neonatal Fc receptor human monoclonal antibody for the prevention of haemolytic disease of the foetus and newborn","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-22T11:12:00Z","last_updated_date":"2020-01-22T11:12:00Z","reference_number":"EMADOC-628903358-1510","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192209-public-summary-positive-opinion-orphan-designation-anti-neonatal-fc-receptor-human-monoclonal-antibody-prevention-haemolytic-disease-foetus-and-newborn_en.pdf"},
    {"id":"46482","name":"EU/3/19/2210: Public summary of positive opinion for orphan designation of autologous CD34+ hematopoietic stem cells with a CRISPR-edited erythroid enhancer region of the bcl11a gene for the treatment of beta-thalassaemia intermedia and major","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-22T11:45:00Z","last_updated_date":"2020-01-22T11:45:00Z","reference_number":"EMADOC-628903358-1532","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192210-public-summary-positive-opinion-orphan-designation-autologous-cd34-hematopoietic-stem-cells-crispr-edited-erythroid-enhancer-region-bcl11a-gene-treatment-beta-thalassaemia-intermedia-and_en.pdf"},
    {"id":"46483","name":"Yohimbine: List of nationally authorised medicinal products - PSUSA/00003136/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-22T14:15:00Z","last_updated_date":"2020-01-22T14:15:00Z","reference_number":"EMA/33967/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/yohimbine-list-nationally-authorised-medicinal-products-psusa00003136201905_en.pdf"},
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    {"id":"46485","name":"EU/3/19/2212: Public summary of positive opinion for orphan designation of leriglitazone for the treatment of Friedreich’s ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-22T14:27:00Z","last_updated_date":"2020-01-22T14:27:00Z","reference_number":"EMADOC-628903358-1523","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192212-public-summary-positive-opinion-orphan-designation-leriglitazone-treatment-friedreichs-ataxia_en.pdf"},
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    {"id":"46490","name":"Court of Justice upholds EMA’s approach to transparency","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-01-22T17:39:00Z","last_updated_date":"2020-01-22T17:39:00Z","reference_number":"EMA/36788/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/court-justice-upholds-emas-approach-transparency_en.pdf"},
    {"id":"46492","name":"Macrogol 4000, macrogol 4000 combinations (oral use): List of nationally authorised medicinal products - PSUSA/00010392/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T10:20:00Z","last_updated_date":"2020-01-23T10:20:00Z","reference_number":"EMA/36889/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/macrogol-4000-macrogol-4000-combinations-oral-use-list-nationally-authorised-medicinal-products-psusa00010392201905_en.pdf"},
    {"id":"46493","name":"Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T10:26:00Z","last_updated_date":"2020-01-23T10:26:00Z","reference_number":"EMA/628079/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/clevidipine-list-nationally-authorised-medicinal-products-psusa00010288201905_en.pdf"},
    {"id":"46495","name":"EU/3/19/2214: Public summary of positive opinion for orphan designation of nirogacestat for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-23T12:18:00Z","last_updated_date":"2020-01-23T12:18:00Z","reference_number":"EMADOC-628903358-1513","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192214-public-summary-positive-opinion-orphan-designation-nirogacestat-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"46496","name":"Addendum to assessment report on Quercus robur L., Quercus petraea. (Matt.) Liebl., Quercus pubescens Willd., cortex","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T12:41:00Z","last_updated_date":"2020-01-23T12:41:00Z","reference_number":"EMA/HMPC/645526/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"46498","name":"EU/3/19/2215: Public summary of positive opinion for orphan designation of paclitaxel for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-23T14:05:00Z","last_updated_date":"2020-01-23T14:05:00Z","reference_number":"EMADOC-628903358-1512","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192215-public-summary-positive-opinion-orphan-designation-paclitaxel-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"46499","name":"EU/3/19/2216: Public summary of positive opinion for orphan designation of 4-Oxo-4H-chromene-2-carboxylic acid (2-(2-4-(2-(6,7-dimethoxy-3,4-dihydro-1H-isoquinolin-2-yl)-ethyl)-(...) for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-23T14:26:00Z","last_updated_date":"2020-01-23T14:26:00Z","reference_number":"EMADOC-628903358-1508","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192216-public-summary-positive-opinion-orphan-designation-4-oxo-4h-chromene-2-carboxylic-acid-2-2-4-2-67-dimethoxy-34-dihydro-1h-isoquinolin-2-yl-ethyl-treatment-soft-tissue-sarcoma_en.pdf"},
    {"id":"46500","name":"Macrogol 3350: List of nationally authorised medicinal products - PSUSA/0001924/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T14:28:00Z","last_updated_date":"2020-01-23T14:28:00Z","reference_number":"EMA/39495/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/macrogol-3350-list-nationally-authorised-medicinal-products-psusa0001924201905_en.pdf"},
    {"id":"46505","name":"Final assessment report on Valeriana officinalis L., radix and Humulus lupulus L., flos - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-01-23T15:35:00Z","last_updated_date":"2020-01-23T15:35:00Z","reference_number":"EMA/HMPC/441766/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"46506","name":"EU/3/19/2217: Public summary of positive opinion for orphan designation of propranolol hydrochloride for the treatment of retinopathy of prematurity","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-01-23T14:40:00Z","last_updated_date":"2020-01-23T14:40:00Z","reference_number":"EMADOC-628903358-1518","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192217-public-summary-positive-opinion-orphan-designation-propranolol-hydrochloride-treatment-retinopathy-prematurity_en.pdf"},
    {"id":"46507","name":"Opinion of the HMPC on a community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos - Revision 1","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T15:38:00Z","last_updated_date":"2020-01-23T15:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-community-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"46508","name":"Final European Union herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos - Revision 1","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T15:42:00Z","last_updated_date":"2020-01-23T15:42:00Z","reference_number":"EMA/HMPC/327107/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"46509","name":"Overview of comments received on community herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T15:48:00Z","last_updated_date":"2020-01-23T15:48:00Z","reference_number":"EMA/HMPC/495797/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"46511","name":"List of references supporting the assessment of Valeriana officinalis L., radix and Humulus lupulus L., flos - Revision 1","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T15:53:00Z","last_updated_date":"2020-01-23T15:53:00Z","reference_number":"EMA/HMPC/441802/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"46512","name":"CHMP summary of positive opinion for Mayzent","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-11-15T16:03:00Z","last_updated_date":"2019-11-15T16:03:00Z","reference_number":"EMA/CHMP/596356/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mayzent_en.pdf-0"},
    {"id":"46513","name":"Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201904","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T16:05:00Z","last_updated_date":"2020-01-23T16:05:00Z","reference_number":"EMA/36860/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/bemiparin-list-nationally-authorised-medicinal-products-psusa00000312201904_en.pdf"},
    {"id":"46514","name":"Misoprostol (gynaecological indication - labour induction): List of nationally authorised medicinal products - PSUSA/00010353/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T16:05:00Z","last_updated_date":"2020-01-23T16:05:00Z","reference_number":"EMA/36948/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gynaecological-indication-labour-induction-list-nationally-authorised-medicinal-products-psusa00010353201905_en.pdf"},
    {"id":"46515","name":"Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T16:05:00Z","last_updated_date":"2020-01-23T16:05:00Z","reference_number":"EMA/34676/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/ozenoxacin-list-nationally-authorised-medicinal-products-psusa00010651201905_en.pdf"},
    {"id":"46516","name":"Isoniazide / rifampicin: List of nationally authorised medicinal products - PSUSA/00001792/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-01-23T16:05:00Z","last_updated_date":"2020-01-23T16:05:00Z","reference_number":"EMA/31710/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/isoniazide-rifampicin-list-nationally-authorised-medicinal-products-psusa00001792201905_en.pdf"},
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    {"id":"46647","name":"First treatment for acute hepatic porphyria","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-01-31T10:31:00Z","last_updated_date":"2020-01-31T10:31:00Z","reference_number":"EMA/CHMP/46675/2020 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-treatment-acute-hepatic-porphyria_en.pdf"},
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    {"id":"46649","name":"Question and answer document in support of the guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products (EMA/CVMP/ERA/52740/2012)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2020-01-31T15:19:00Z","last_updated_date":"2020-01-31T15:19:00Z","reference_number":"EMA/593989/2019 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/question-and-answer-document-support-guideline-assessment-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpvb-substances-veterinary-medicinal-products_en.pdf"},
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    {"id":"46672","name":"Lemtrada Article 20 procedure - Scientific conclusions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-02-04T14:58:00Z","last_updated_date":"2020-02-04T14:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_bg.pdf-0","es":"https://www.ema.europa.eu/es/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_es.pdf-0","cs":"https://www.ema.europa.eu/cs/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_cs.pdf-0","da":"https://www.ema.europa.eu/da/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_da.pdf-0","de":"https://www.ema.europa.eu/de/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_de.pdf-0","et":"https://www.ema.europa.eu/et/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_et.pdf-0","el":"https://www.ema.europa.eu/el/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_el.pdf-0","fr":"https://www.ema.europa.eu/fr/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_fr.pdf-0","hr":"https://www.ema.europa.eu/hr/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_hr.pdf-0","it":"https://www.ema.europa.eu/it/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_it.pdf-0","lv":"https://www.ema.europa.eu/lv/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_lv.pdf-0","lt":"https://www.ema.europa.eu/lt/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_lt.pdf-0","hu":"https://www.ema.europa.eu/hu/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_hu.pdf-0","mt":"https://www.ema.europa.eu/mt/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_mt.pdf-0","nl":"https://www.ema.europa.eu/nl/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_nl.pdf-0","pl":"https://www.ema.europa.eu/pl/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_pl.pdf-0","pt":"https://www.ema.europa.eu/pt/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_pt.pdf-0","ro":"https://www.ema.europa.eu/ro/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_ro.pdf-0","sk":"https://www.ema.europa.eu/sk/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_sk.pdf-0","sl":"https://www.ema.europa.eu/sl/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_sl.pdf-0","fi":"https://www.ema.europa.eu/fi/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_fi.pdf-0","sv":"https://www.ema.europa.eu/sv/documents/referral/lemtrada-article-20-procedure-scientific-conclusions_sv.pdf-0"}},
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    {"id":"46674","name":"Public statement on Fexeric: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-02-04T15:45:00Z","last_updated_date":"2020-02-04T15:45:00Z","reference_number":"EMA/4863/2020 ","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-fexeric-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"46675","name":"EMA to support development of vaccines and treatments for novel coronavirus","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-02-04T16:21:00Z","last_updated_date":"2020-02-04T16:21:00Z","reference_number":"EMA/57041/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-support-development-vaccines-and-treatments-novel-coronavirus_en.pdf"},
    {"id":"46676","name":"Valerian root and hop strobile: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2020-02-05T17:30:00Z","last_updated_date":"2020-02-05T17:30:00Z","reference_number":"EMA/539891/2019 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/valerian-root-and-hop-strobile-summary-public_en.pdf"},
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    {"id":"46685","name":"Withdrawal assessment report for Idhifa","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-02-07T12:24:00Z","last_updated_date":"2020-02-07T12:24:00Z","reference_number":"EMA/CHMP/13746/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-idhifa_en.pdf"},
    {"id":"46687","name":"Final programming document 2020-2022","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-02-10T09:50:00Z","last_updated_date":"2020-02-10T09:50:00Z","reference_number":"EMA/9529/2020","document_url":"https://www.ema.europa.eu/en/documents/report/final-programming-document-2020-2022_en.pdf"},
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    {"id":"46696","name":"Agenda - PRAC draft agenda of meeting 10-13 February 2020","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-02-10T15:28:00Z","last_updated_date":"2020-02-10T15:28:00Z","reference_number":"EMA/PRAC/20444/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-10-13-february-2020_en.pdf"},
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    {"id":"46701","name":"Withdrawal assessment report for Xyndari","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2020-02-11T14:41:00Z","last_updated_date":"2020-02-11T14:41:00Z","reference_number":"EMA/CHMP/257513/2019","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-xyndari_en.pdf"},
    {"id":"46704","name":"ICH M9 on biopharmaceutics classification system based biowaivers - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-02-11T14:09:00Z","last_updated_date":"2020-02-11T14:09:00Z","reference_number":"EMA/CHMP/ICH/493213/2018 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m9-biopharmaceutics-classification-system-based-biowaivers-step-5_en.pdf"},
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    {"id":"46719","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: January 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-02-12T10:00:00Z","last_updated_date":"2020-02-12T10:00:00Z","reference_number":"EMA/CAT/54845/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-january-2020_en.pdf"},
    {"id":"46734","name":"EU/3/19/2218: Public summary of opinion on orphan designation: (2S,3R,4R,5S)-2-(Hydroxymethyl)-1-pentylpiperidine-3,4,5-triol for the treatment of GM2 gangliosidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-02-12T02:00:00Z","last_updated_date":"2020-02-12T02:00:00Z","reference_number":"EMADOC-628903358-1573 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192218-public-summary-opinion-orphan-designation-2s3r4r5s-2-hydroxymethyl-1-pentylpiperidine-345-triol-treatment-gm2-gangliosidosis_en.pdf"},
    {"id":"46735","name":"EU/3/19/2219: Public summary of opinion on orphan designation: 4-((E)-(5-(2-(2-((S)-2-((S)-1-(L-threonyl-L-lysyl)pyrrolidine-2-carboxamido)-5-guanidinopentanamido)acetamido)-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-02-12T02:00:00Z","last_updated_date":"2020-02-12T02:00:00Z","reference_number":"EMADOC-628903358-1566","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192219-public-summary-opinion-orphan-designation-4-e-5-2-2-s-2-s-1-l-threonyl-l-lysylpyrrolidine-2-carboxamido-5-guanidinopentanamidoacetamido_en.pdf"},
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    {"id":"46774","name":"Overview of comments received on Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/QWP/153641/2018)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2020-02-17T17:39:00Z","last_updated_date":"2020-02-17T17:39:00Z","reference_number":"EMA/CVMP/QWP/434956/2019 ","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-risk-management-requirements-elemental-impurities-veterinary-medicinal-products-emacvmpqwp1536412018_en.pdf"},
    {"id":"46775","name":"Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-02-17T17:41:00Z","last_updated_date":"2020-02-17T17:41:00Z","reference_number":"EMA/CVMP/QWP/153641/2018 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-management-requirements-elemental-impurities-veterinary-medicinal-products_en.pdf"},
    {"id":"46776","name":"Public statement on Nonafact","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-02-18T10:27:00Z","last_updated_date":"2020-02-18T10:27:00Z","reference_number":"EMA/326040/2019","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-nonafact_en.pdf"},
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    {"id":"46791","name":"Public statement on Iblias : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-02-18T14:44:00Z","last_updated_date":"2020-02-18T14:44:00Z","reference_number":"EMA/63357/2020 ","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-iblias-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"46808","name":"Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201907","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-02-20T09:32:00Z","last_updated_date":"2020-02-20T09:32:00Z","reference_number":"EMA/89998/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-hydrochloride-phenylephrine-hydrochloride-tropicamide-list-nationally-authorised-medicinal-products-psusa00010390201907_en.pdf"},
    {"id":"46812","name":"Direct healthcare professional communication (DHPC): Risks associated with systemic exposure to estradiol creams","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-02-20T15:20:00Z","last_updated_date":"2020-02-20T15:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-risks-associated-systemic-exposure-estradiol-creams_en.pdf"},
    {"id":"46817","name":"Clebopride: List of nationally authorised medicinal products - PSUSA/00000789/201906","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-02-21T09:56:00Z","last_updated_date":"2020-02-21T09:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/clebopride-list-nationally-authorised-medicinal-products-psusa00000789201906_en.pdf"},
    {"id":"46829","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 2020","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-02-21T14:51:00Z","last_updated_date":"2020-02-21T14:51:00Z","reference_number":"EMA/CVMP/61915/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-18-20-february-2020_en.pdf"},
    {"id":"46831","name":"CVMP summary of positive opinion for Vectormune FP ILT + AE","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-02-21T15:06:00Z","last_updated_date":"2020-02-21T15:06:00Z","reference_number":"EMA/CVMP/62052/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vectormune-fp-ilt-ae_en.pdf"},
    {"id":"46832","name":"CVMP summary of positive opinion for Tulissin","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-02-21T15:21:00Z","last_updated_date":"2020-02-21T15:21:00Z","reference_number":"EMA/CVMP/50662/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-tulissin_en.pdf"},
    {"id":"46833","name":"CVMP summary of positive opinion for Tulaven","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-02-21T15:32:00Z","last_updated_date":"2020-02-21T15:32:00Z","reference_number":"EMA/CVMP/50678/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-tulaven_en.pdf"},
    {"id":"46834","name":"CVMP post-authorisation summary of positive opinion for Clynav","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-02-21T15:41:00Z","last_updated_date":"2020-02-21T15:41:00Z","reference_number":"EMA/CVMP/624348/2019","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-clynav_en.pdf"},
    {"id":"46837","name":"Dienogest / estradiol (HRT indication): List of nationally authorised medicinal products - PSUSA/00010443/201906","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-02-24T16:05:00Z","last_updated_date":"2020-02-24T16:05:00Z","reference_number":"EMA/90195/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/dienogest-estradiol-hrt-indication-list-nationally-authorised-medicinal-products-psusa00010443201906_en.pdf"},
    {"id":"46844","name":"EU/3/19/2226: Public summary of positive opinion for orphan designation: (E)-2-((2S,4S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-2-yl)-10-...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-02-24T02:00:00Z","last_updated_date":"2020-02-24T02:00:00Z","reference_number":"EMADOC-628903358-1671","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192226-public-summary-positive-opinion-orphan-designation-e-2-2s4s-4-2r4s5s6s-4-amino-5-hydroxy-6-methyltetrahydro-2h-pyran-2-yloxy-2512-trihydroxy-7-methoxy-611-dioxo-1234611-hexahydrotetracen-2_en.pdf"},
    {"id":"46845","name":"EU/3/19/2227: Public summary of opinion on orphan designation: 2-(Isopropylamino)-3-methyl-5-(6-methyl-5-((2-(1-methyl-1H-pyrazol-4yl)pyridin-4-yl)oxy)pyridin-2-yl)pyrimidin-4(3H)-one","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-24T15:50:00Z","last_updated_date":"2020-02-24T15:50:00Z","reference_number":"EMADOC-628903358-1672 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192227-public-summary-opinion-orphan-designation-2-isopropylamino-3-methyl-5-6-methyl-5-2-1-methyl-1h-pyrazol-4ylpyridin-4-yloxypyridin-2-ylpyrimidin-43h-one_en.pdf"},
    {"id":"46846","name":"EU/3/19/2228: Public summary of opinion on orphan designation: 5,7-Dichloro-2-((ethylamino)methyl)-8-hydroxy-3-methylquinazolin-4(3H)one mesilate for the treatment of multiple system atrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1673 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192228-public-summary-opinion-orphan-designation-57-dichloro-2-ethylaminomethyl-8-hydroxy-3-methylquinazolin-43hone-mesilate-treatment-multiple-system-atrophy_en.pdf"},
    {"id":"46847","name":"EU/3/19/2229: Public summary of opinion on orphan designation: Adeno-associated virus vector encoding human phenylalanine hydroxylase for the treatment of phenylalanine hydroxylase deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1674","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192229-public-summary-opinion-orphan-designation-adeno-associated-virus-vector-encoding-human-phenylalanine-hydroxylase-treatment-phenylalanine-hydroxylase-deficiency_en.pdf"},
    {"id":"46848","name":"EU/3/19/2229: Public summary of opinion on orphan designation: Efgartigimod alfa for the treatment of immune thrombocytopenia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1668 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192229-public-summary-opinion-orphan-designation-efgartigimod-alfa-treatment-immune-thrombocytopenia_en.pdf"},
    {"id":"46849","name":"EU/3/19/2231: Public summary of opinion on orphan designation: H-Leu-Pro-Pro-Leu-Pro-Tyr-Pro-OH for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1675 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192231-public-summary-opinion-orphan-designation-h-leu-pro-pro-leu-pro-tyr-pro-oh-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"46850","name":"EU/3/19/2232: Public summary of opinion on orphan designation: Lactobacillus plantarum for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1669","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192232-public-summary-opinion-orphan-designation-lactobacillus-plantarum-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"46851","name":"EU/3/19/2233: Public summary of opinion on orphan designation: Navitoclax for the treatment of myelofibrosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1678 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192233-public-summary-opinion-orphan-designation-navitoclax-treatment-myelofibrosis_en.pdf"},
    {"id":"46852","name":"EU/3/19/2234: Public summary of opinion on orphan designation: Pamrevlumab for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1670 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192234-public-summary-opinion-orphan-designation-pamrevlumab-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"46853","name":"EU/3/19/2235: Public summary of opinion on orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against SERPINA1 mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T15:50:00Z","last_updated_date":"2020-02-25T15:50:00Z","reference_number":"EMADOC-628903358-1679 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3192235-public-summary-opinion-orphan-designation-synthetic-double-stranded-sirna-oligonucleotide-directed-against-serpina1-mrna-and-containing-four-modified-nucleosides-which-form-ligand-cluster_en.pdf"},
    {"id":"46854","name":"Public summary of negative opinion for orphan designation of naltrexone for the treatment of fibromyalgia (Nov 2019)","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-02-24T15:43:00Z","last_updated_date":"2020-02-24T15:43:00Z","reference_number":"EMADOC-628903358-1680 ","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-negative-opinion-orphan-designation-naltrexone-treatment-fibromyalgia-nov-2019_en.pdf"},
    {"id":"46856","name":"Minutes - European Union (EU) International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting (Oct 2019)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T10:49:00Z","last_updated_date":"2020-03-03T10:03:00Z","reference_number":"EMA/580947/2019 ","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-union-eu-international-organization-standardization-iso-identification-medicinal-products-idmp-substance-product-organisation-and-referential-data-spor-task-force-meeting-oct-2019_en.pdf"},
    {"id":"46857","name":"Presentation - SPOR data services update","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spor-data-services-update_en.pdf-0"},
    {"id":"46858","name":"Presentation - Update on the New Veterinary Regulation with a focus on the Union Product Database","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-new-veterinary-regulation-focus-union-product-database_en.pdf"},
    {"id":"46859","name":"Presentation - IDMP PMS TOM - Industry perspectives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-idmp-pms-tom-industry-perspectives_en.pdf"},
    {"id":"46860","name":"Presentation - Implementation of the UPD / Architectural Advice considering the data feed process for human and veterinary synergies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-upd-architectural-advice-considering-data-feed-process-human-and-veterinary-synergies_en.pdf"},
    {"id":"46861","name":"Presentation - EU Implementation Guide","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-implementation-guide_en.pdf"},
    {"id":"46862","name":"Presentation - S&PMS plan and progress","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spms-plan-and-progress_en.pdf"},
    {"id":"46863","name":"Presentation - Report from the WHO workshop on IDMP","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-report-who-workshop-idmp_en.pdf"},
    {"id":"46864","name":"Presentation - EU-SRS PoC project update","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-srs-poc-project-update_en.pdf"},
    {"id":"46865","name":"Presentation - SMS update to ISO IDMP task force","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:00:00Z","last_updated_date":"2020-02-25T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sms-update-iso-idmp-task-force_en.pdf"},
    {"id":"46866","name":"Agenda - Substance, Product, Organisation and Referential data (SPOR) Task Force meeting (Oct 2019)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T10:43:00Z","last_updated_date":"2020-02-25T10:43:00Z","reference_number":"EMA/481333/2019 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-substance-product-organisation-and-referential-data-spor-task-force-meeting-oct-2019_en.pdf"},
    {"id":"46869","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 28-31 January 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:42:00Z","last_updated_date":"2020-02-25T09:42:00Z","reference_number":"EMEA/PDCO/68072/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-28-31-january-2020_en.pdf"},
    {"id":"46870","name":"Agnus castus fruit: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T09:58:00Z","last_updated_date":"2020-02-25T09:58:00Z","reference_number":"EMA/266692/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/agnus-castus-fruit-summary-public_en.pdf"},
    {"id":"46873","name":"Direct healthcare professional communication (DHPC): Mepact 4mg (mifamurtide): Potential for filter leakage or malfunction","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-02-25T13:35:00Z","last_updated_date":"2020-02-25T13:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-mepact-4mg-mifamurtide-potential-filter-leakage-or-malfunction_en.pdf"},
    {"id":"46885","name":"Agenda - PCWP/HCPWP joint meeting on 3-4 March 2020","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-02-27T13:45:00Z","last_updated_date":"2020-03-06T12:10:00Z","reference_number":"EMA/633892/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pcwphcpwp-joint-meeting-3-4-march-2020_en.pdf"},
    {"id":"46890","name":"Start of Union reviews adopted during the CHMP meeting of 24-27 February 2020","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2020-02-28T12:00:00Z","last_updated_date":"2020-02-28T12:00:00Z","reference_number":"EMA/103570/2020","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-union-reviews-adopted-during-chmp-meeting-24-27-february-2020_en.pdf"},
    {"id":"46891","name":"CHMP summary of positive opinion for Fetcroja","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-02-28T12:00:00Z","last_updated_date":"2020-02-28T12:00:00Z","reference_number":"EMA/CHMP/73102/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-fetcroja_en.pdf"},
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    {"id":"46893","name":"CHMP post-authorisation summary of positive opinion for Ofev (II-26)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-02-28T12:00:00Z","last_updated_date":"2020-02-28T12:00:00Z","reference_number":"EMA/CHMP/102818/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ofev-ii-26_en.pdf"},
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    {"id":"46905","name":"CHMP summary of positive opinion for Tigecycline Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-02-28T11:19:00Z","last_updated_date":"2020-02-28T11:19:00Z","reference_number":"EMA/CHMP/73022/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tigecycline-accord_en.pdf"},
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    {"id":"46907","name":"Panexcell Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-02-28T12:01:00Z","last_updated_date":"2020-02-28T12:01:00Z","reference_number":"EMA/95202/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/panexcell-article-31-referral-review-started_en.pdf"},
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    {"id":"46922","name":"Qualification opinion on Multiple sclerosis clinical outcome assessment (MSCOA)","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2020-03-02T13:39:00Z","last_updated_date":"2020-03-02T13:39:00Z","reference_number":"EMA/CHMP/SAWP/74371/2020","document_url":"https://www.ema.europa.eu/en/documents/other/qualification-opinion-multiple-sclerosis-clinical-outcome-assessment-mscoa_en.pdf"},
    {"id":"46923","name":"Overview of comments received on 'Draft qualification opinion on Multiple Sclerosis Clinical Outcome Assessment (MSCOA) qualification opinion'","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-03-02T13:41:00Z","last_updated_date":"2020-03-02T13:41:00Z","reference_number":"EMA/550514/2019","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-qualification-opinion-multiple-sclerosis-clinical-outcome-assessment-mscoa-qualification-opinion_en.pdf"},
    {"id":"46927","name":"Agenda - Multi-stakeholder workshop to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-03-02T15:29:00Z","last_updated_date":"2020-03-02T15:29:00Z","reference_number":"EMA/464742/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-multi-stakeholder-workshop-support-implementation-article-117-mdr-2017745-drug-device-combinations_en.pdf"},
    {"id":"46928","name":"Public statement on Varuby: Withdrawal of the marketing authorisation in the European Union","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2020-03-02T15:44:00Z","last_updated_date":"2020-03-02T15:44:00Z","reference_number":"EMA/100421/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/public-statement-varuby-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"46929","name":"Public statement on Xiapex : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-03-02T16:39:00Z","last_updated_date":"2020-03-02T16:39:00Z","reference_number":"EMA/95504/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-xiapex-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"46930","name":"Update on nitrosamines in EU medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-03-03T10:12:00Z","last_updated_date":"2020-03-03T10:12:00Z","reference_number":"EMA/105779/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-nitrosamines-eu-medicines_en.pdf"},
    {"id":"46932","name":"Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-03-04T09:30:00Z","last_updated_date":"2020-03-04T09:30:00Z","reference_number":"EMA/CHMP/ICH/78332/2020","document_url":"https://www.ema.europa.eu/en/documents/other/note-eu-implementation-ich-q12-guideline-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf"},
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    {"id":"46943","name":"Public statement on Picato: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-03-04T17:34:00Z","last_updated_date":"2020-03-04T17:34:00Z","reference_number":"EMA/91080/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-picato-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"46947","name":"Panexcell Article-31 referral - Annex I","type":"referral","status":"Draft","consultation_date":"","first_published_date":"2020-03-05T15:07:00Z","last_updated_date":"2020-03-05T15:07:00Z","reference_number":"EMA/116598/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/panexcell-article-31-referral-annex-i_en.pdf"},
    {"id":"46949","name":"Minutes of the 106th meeting of the Management Board: 18-19 December 2019","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2020-03-05T15:59:00Z","last_updated_date":"2020-03-05T15:59:00Z","reference_number":"EMA/MB/542228/2019","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-106th-meeting-management-board-18-19-december-2019_en.pdf"},
    {"id":"46950","name":"Presentation - 1.1 EMA recommendations from the Regulatory Science Strategy to 2025: implications for patients and healthcare professionals (T. Humphreys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-03-06T10:00:00Z","last_updated_date":"2020-03-06T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11-ema-recommendations-regulatory-science-strategy-2025-implications-patients-and-healthcare-professionals-t-humphreys_en.pdf"},
    {"id":"46951","name":"Presentation - 1.2 European Medicines Regulatory Network Strategy to 2025: introduction on the route to joint strategy, stakeholder consultation process, timelines (M. Carr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-03-06T10:00:00Z","last_updated_date":"2020-03-06T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-12-european-medicines-regulatory-network-strategy-2025-introduction-route-joint-strategy-stakeholder-consultation-process-timelines-m-carr_en.pdf"},
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    {"id":"46973","name":"Withdrawal assessment report for Ekesivy","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-03-06T13:45:00Z","last_updated_date":"2020-03-06T13:45:00Z","reference_number":"EMA/603042/2019","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-ekesivy_en.pdf"},
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    {"id":"47182","name":"Methocarbamol / paracetamol Article 31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-03-27T12:00:00Z","last_updated_date":"2020-06-17T11:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/methocarbamol-paracetamol-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"47183","name":"Rituximab Mabion: Withdrawal letter","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2020-03-30T15:00:00Z","last_updated_date":"2020-03-30T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/rituximab-mabion-withdrawal-letter_en.pdf"},
    {"id":"47184","name":"Benefits of medicines containing combination of methocarbamol and paracetamol continue to outweigh risks","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-03-27T12:00:00Z","last_updated_date":"2020-03-27T12:00:00Z","reference_number":"EMA/146374/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/benefits-medicines-containing-combination-methocarbamol-and-paracetamol-continue-outweigh-risks_en.pdf"},
    {"id":"47186","name":"CHMP summary of positive opinion for Zeposia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-03-27T13:25:00Z","last_updated_date":"2020-03-27T13:25:00Z","reference_number":"EMA/CHMP/136468/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zeposia_en.pdf"},
    {"id":"47187","name":"Recommendations to restrict use of fosfomycin antibiotics","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-03-27T10:37:00Z","last_updated_date":"2020-03-27T10:37:00Z","reference_number":"EMA/670563/2019","document_url":"https://www.ema.europa.eu/en/documents/press-release/recommendations-restrict-use-fosfomycin-antibiotics_en.pdf"},
    {"id":"47188","name":"CHMP post-authorisation summary of positive opinion for Jorveza (X-07-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-03-27T12:00:00Z","last_updated_date":"2020-03-27T12:00:00Z","reference_number":"EMA/CHMP/117524/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jorveza-x-07-g_en.pdf"},
    {"id":"47189","name":"CHMP post-authorisation summary of positive opinion for Adcetris (II-70)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-03-27T12:00:00Z","last_updated_date":"2020-03-27T12:00:00Z","reference_number":"EMA/CHMP/158590/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adcetris-ii-70_en.pdf"},
    {"id":"47190","name":"New gene therapy to treat spinal muscular atrophy","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-03-27T11:18:00Z","last_updated_date":"2020-03-31T17:30:00Z","reference_number":"EMA/163207/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-gene-therapy-treat-spinal-muscular-atrophy_en.pdf"},
    {"id":"47193","name":"EMA recommends refusal of authorisation for Budesonide Sun (budesonide, nebuliser suspension) in the EU","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2020-03-27T11:44:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/148006/2020 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/ema-recommends-refusal-authorisation-budesonide-sun-budesonide-nebuliser-suspension-eu_en.pdf"},
    {"id":"47194","name":"CHMP summary of positive opinion for Atectura Breezhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-03-31T16:02:00Z","last_updated_date":"2020-04-03T17:20:00Z","reference_number":"EMA/CHMP/74496/2020 Rev. ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-atectura-breezhaler_en.pdf"},
    {"id":"47196","name":"CHMP summary of positive opinion for Bemrist Breezhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-03-31T16:08:00Z","last_updated_date":"2020-04-03T17:20:00Z","reference_number":"EMA/CHMP/138090/2020 Rev.","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bemrist-breezhaler_en.pdf"},
    {"id":"47198","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 2-4 March 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-03-27T13:23:00Z","last_updated_date":"2020-03-27T13:23:00Z","reference_number":"EMA/HMPC/121831/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-2-4-march-2020_en.pdf"},
    {"id":"47212","name":"COMP meeting report on the review of applications for orphan designation: March 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-03-30T13:49:00Z","last_updated_date":"2020-03-30T13:49:00Z","reference_number":"EMA/COMP/152850/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-march-2020_en.pdf"},
    {"id":"47220","name":"CHMP ORGAM agenda for the meeting on 2 December 2019","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2020-03-30T14:58:00Z","last_updated_date":"2020-03-30T14:58:00Z","reference_number":"EMA/CHMP/614413/2019","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-2-december-2019_en.pdf"},
    {"id":"47222","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Rituximab Mabion","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2020-03-30T15:32:00Z","last_updated_date":"2020-06-24T02:00:00Z","reference_number":"EMA/163447/2020","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-rituximab-mabion_sv.pdf"}},
    {"id":"47223","name":"Letter of support for Islet autoantibodies as enrichment biomarkers for type 1 diabetes prevention studies, through a quantitative disease progression model","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-03-30T17:22:00Z","last_updated_date":"2020-03-30T17:22:00Z","reference_number":"EMA/625951/2019","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-islet-autoantibodies-enrichment-biomarkers-type-1-diabetes-prevention-studies-through-quantitative-disease-progression-model_en.pdf"},
    {"id":"47247","name":"EMA Regulatory Science to 2025 - Strategic reflection","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-03-31T17:00:00Z","last_updated_date":"2020-03-31T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf"},
    {"id":"47248","name":"Update on treatments and vaccines against COVID-19 under development","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-03-31T16:00:00Z","last_updated_date":"2020-03-31T16:00:00Z","reference_number":"EMA/160083/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/update-treatments-and-vaccines-against-covid-19-under-development_en.pdf"},
    {"id":"47249","name":"Analysis and summaries of public consultation results: EMA Regulatory Science to 2025 - Strategic reflection","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2020-03-31T17:00:00Z","last_updated_date":"2020-04-02T15:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/comments/analysis-and-summaries-public-consultation-results-ema-regulatory-science-2025-strategic-reflection_en.pdf"},
    {"id":"47250","name":"Advancing regulatory science in the EU – new strategy adopted","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-03-31T16:59:00Z","last_updated_date":"2020-03-31T16:59:00Z","reference_number":"EMA/132421/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/advancing-regulatory-science-eu-new-strategy-adopted_en.pdf"},
    {"id":"47251","name":"Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2020","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2020-04-01T10:30:00Z","last_updated_date":"2020-04-01T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/explanatory-note-general-fees-payable-european-medicines-agency-1-april-2020_en.pdf"},
    {"id":"47252","name":"Commission Regulation (EU) 2020/422 of 19 March 2020 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2020-04-01T10:30:00Z","last_updated_date":"2020-04-01T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/commission-regulation-eu-2020422-19-march-2020-amending-council-regulation-ec-no-29795-regards-adjustment-fees-european-medicines-agency-inflation-rate-effect-1-april-2020_en.pdf"},
    {"id":"47254","name":"Cyproterone Article-31 referral - PRAC assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2020-04-01T10:50:00Z","last_updated_date":"2020-04-01T10:50:00Z","reference_number":"EMA/134740/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/cyproterone-article-31-referral-prac-assessment-report_en.pdf"},
    {"id":"47255","name":"ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-04-01T10:47:00Z","last_updated_date":"2020-04-01T10:47:00Z","reference_number":"EMA/CHMP/ICH/616110/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-s11-nonclinical-safety-testing-support-development-paediatric-pharmaceuticals-step-5_en.pdf"},
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    {"id":"47430","name":"Picato Article-20 referral - EMA review of Picato concludes medicine’s risks outweigh its benefits","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-04-17T14:24:00Z","last_updated_date":"2020-04-17T14:24:00Z","reference_number":"EMA/194393/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/picato-article-20-referral-ema-review-picato-concludes-medicines-risks-outweigh-its-benefits_en.pdf"},
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    {"id":"47439","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: February 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-04-20T15:45:00Z","last_updated_date":"2020-04-20T15:45:00Z","reference_number":"EMA/144648/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-february-2020_en.pdf"},
    {"id":"47440","name":"Information note on the format and validity features of electronic certificates for medicines issued by the European Medicines Agency","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2020-04-20T16:56:00Z","last_updated_date":"2023-01-16T15:20:00Z","reference_number":"EMA/206719/2020 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/information-note-format-and-validity-features-electronic-certificates-medicines-issued-european-medicines-agency_en.pdf"},
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    {"id":"47454","name":"Agenda - CAT agenda of the 22-24 April 2020 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-04-22T12:05:00Z","last_updated_date":"2020-04-22T12:05:00Z","reference_number":"EMA/CAT/220061/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-22-24-april-2020-meeting_en.pdf"},
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    {"id":"47459","name":"COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-23T11:00:00Z","last_updated_date":"2020-04-23T13:58:00Z","reference_number":"EMA/202483/2020 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/press-release/covid-19-reminder-risk-serious-side-effects-chloroquine-and-hydroxychloroquine_en.pdf"},
    {"id":"47461","name":"Assessment report on Aesculus hippocastanum L., semen Final - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-04-23T13:23:00Z","last_updated_date":"2020-04-23T13:23:00Z","reference_number":"EMA/HMPC/638244/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/assessment-report-aesculus-hippocastanum-l-semen-final-revision-1_en.pdf"},
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    {"id":"47465","name":"Opinion of the HMPC on a European Union herbal monograph on Aesculus hippocastanum L., semen - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2020-04-23T13:40:00Z","last_updated_date":"2020-04-23T13:40:00Z","reference_number":"EMA/HMPC/22334/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-aesculus-hippocastanum-l-semen-revision-1_en.pdf"},
    {"id":"47484","name":"Amlodipine / losartan : List of nationally authorised medicinal products - PSUSA/00010512/201901","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-04-24T12:12:00Z","last_updated_date":"2020-04-24T12:12:00Z","reference_number":"EMA/229121/2020 ","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-losartan-list-nationally-authorised-medicinal-products-psusa00010512201901_en.pdf"},
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    {"id":"47487","name":"EU actions to support availability of medicines during COVID-19 pandemic – update #3","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-24T14:51:00Z","last_updated_date":"2020-04-24T14:51:00Z","reference_number":"EMA/223887/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-3_en.pdf"},
    {"id":"47494","name":"Final assessment report on Allium sativum L., bulbus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-04-28T10:37:00Z","last_updated_date":"2020-04-28T10:37:00Z","reference_number":"EMA/HMPC/7686/2013 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-allium-sativum-l-bulbus_en.pdf"},
    {"id":"47495","name":"Final assessment report on Allium sativum L., bulbus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-04-28T10:37:00Z","last_updated_date":"2020-04-28T10:37:00Z","reference_number":"EMA/HMPC/7686/2013 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-allium-sativum-l-bulbus_en.pdf-0"},
    {"id":"47496","name":"Final list of references supporting the assessment of Allium sativum L., bulbus","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T10:38:00Z","last_updated_date":"2020-04-28T10:38:00Z","reference_number":"EMA/HMPC/7687/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-allium-sativum-l-bulbus_en.pdf"},
    {"id":"47497","name":"Final European Union herbal monograph on Allium sativum L., bulbus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2020-04-28T10:43:00Z","last_updated_date":"2020-04-28T10:43:00Z","reference_number":"EMA/HMPC/7685/2013 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-allium-sativum-l-bulbus_en.pdf"},
    {"id":"47498","name":"Overview of comments received on European Union herbal monograph on Allium sativum L., bulbus EMA/HMPC/7685/2013)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T10:44:00Z","last_updated_date":"2020-04-28T10:44:00Z","reference_number":"EMA/HMPC/48689/2017 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-allium-sativum-l-bulbus-emahmpc76852013_en.pdf"},
    {"id":"47499","name":"EMA warns against using unproven cell-based therapies","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T12:17:00Z","last_updated_date":"2020-04-28T12:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/ema-warns-against-using-unproven-cell-based-therapies_en.pdf"},
    {"id":"47501","name":"Template for pharmacovigilance inspection information sharing","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T12:57:00Z","last_updated_date":"2020-04-28T12:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-pharmacovigilance-inspection-information-sharing_en.doc"},
    {"id":"47503","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 March 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T15:08:00Z","last_updated_date":"2020-04-28T15:08:00Z","reference_number":"EMA/175935/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-24-27-march-2020_en.pdf"},
    {"id":"47504","name":"Thiocolcicoside: List of nationally authorised medicinal products -  EMEA/H/N/PSR/J/0023","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T17:30:00Z","last_updated_date":"2020-04-28T17:30:00Z","reference_number":"EMA/230507/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/thiocolcicoside-list-nationally-authorised-medicinal-products-emeahnpsrj0023_en.pdf"},
    {"id":"47505","name":"Thiocolcicoside: CMDh Scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0023","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-04-28T17:34:00Z","last_updated_date":"2020-04-28T17:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/thiocolcicoside-cmdh-scientific-conclusions-amendments-product-information-and-implementation-timetable-emeahnpsrj0023_sv.pdf"}},
    {"id":"47507","name":"Direct healthcare professional communication (DHPC): Restrictions in use of cyproterone acetate due to risk of meningioma","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-04-29T11:52:00Z","last_updated_date":"2020-04-29T11:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-restrictions-use-cyproterone-acetate-due-risk-meningioma_en.pdf"},
    {"id":"47511","name":"Nifuroxazide : List of nationally authorised medicinal products - PSUSA/00002160/201908","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-04-29T14:12:00Z","last_updated_date":"2020-04-29T14:12:00Z","reference_number":"EMA/222200/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/nifuroxazide-list-nationally-authorised-medicinal-products-psusa00002160201908_en.pdf"},
    {"id":"47512","name":"CHMP summary of positive opinion for Cabazitaxel Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T18:00:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/CHMP/200669/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-cabazitaxel-accord_en.pdf"},
    {"id":"47513","name":"Annual report of the Pharmacovigilance Inspectors Working Group for 2017","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2020-04-29T15:08:00Z","last_updated_date":"2020-04-29T15:08:00Z","reference_number":"EMA/INS/PhV/742931/2017","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-pharmacovigilance-inspectors-working-group-2017_en.pdf"},
    {"id":"47516","name":"Union procedure on the follow-up of pharmacovigilance inspections","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T10:36:00Z","last_updated_date":"2020-04-30T10:36:00Z","reference_number":"EMA/INS/PhV/327777/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/union-procedure-follow-pharmacovigilance-inspections_en.pdf"},
    {"id":"47517","name":"CHMP summary of positive opinion for Insulin aspart Sanofi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T16:15:00Z","last_updated_date":"2020-04-30T16:15:00Z","reference_number":"EMA/CHMP/207078/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-insulin-aspart-sanofi_en.pdf"},
    {"id":"47519","name":"CHMP post-authorisation summary of positive opinion for Darzalex (X-32)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T17:28:00Z","last_updated_date":"2020-04-30T17:28:00Z","reference_number":"EMA/CHMP/233457/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-x-32_en.pdf"},
    {"id":"47522","name":"CHMP summary of positive opinion for Daurismo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T18:00:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/CHMP/222209/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-daurismo_en.pdf"},
    {"id":"47523","name":"CHMP summary of positive opinion for Enerzair Breezhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T12:01:00Z","last_updated_date":"2020-04-30T12:01:00Z","reference_number":"EMA/CHMP/64858/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-enerzair-breezhaler_en.pdf"},
    {"id":"47524","name":"CHMP summary of positive opinion for Paliperidone Janssen-Cilag International","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T18:06:00Z","last_updated_date":"2020-04-30T18:06:00Z","reference_number":"EMA/CHMP/230829/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-paliperidone-janssen-cilag-international_en.pdf"},
    {"id":"47525","name":"CHMP post-authorisation summary of positive opinion for Ecalta (II-40)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T13:49:00Z","last_updated_date":"2020-04-30T13:49:00Z","reference_number":"EMA/CHMP/213950/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ecalta-ii-40_en.pdf"},
    {"id":"47526","name":"CHMP post-authorisation summary of positive opinion for Suboxone (X-42)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T13:57:00Z","last_updated_date":"2020-04-30T13:57:00Z","reference_number":"EMA/CHMP/219873/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-suboxone-x-42_en.pdf"},
    {"id":"47527","name":"CHMP summary of positive opinion for Zimbus Breezhaler","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T14:07:00Z","last_updated_date":"2020-04-30T14:07:00Z","reference_number":"EMA/CHMP/138288/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zimbus-breezhaler_en.pdf"},
    {"id":"47528","name":"CHMP post-authorisation summary of positive opinion for Ultomiris (II-02)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T14:10:00Z","last_updated_date":"2020-04-30T14:10:00Z","reference_number":"EMA/CHMP/142111/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ultomiris-ii-02_en.pdf"},
    {"id":"47529","name":"CHMP post-authorisation summary of positive opinion for Sovaldi (X-59-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T14:10:00Z","last_updated_date":"2020-04-30T14:10:00Z","reference_number":"EMA/CHMP/54432/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sovaldi-x-59-g_en.pdf"},
    {"id":"47530","name":"Picato Article-20 referral - Risks of Picato for actinic keratosis outweigh benefits","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-04-30T15:05:00Z","last_updated_date":"2020-11-16T11:38:00Z","reference_number":"EMA/368170/2020/Corr.1","document_url":"https://www.ema.europa.eu/en/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/picato-article-20-referral-risks-picato-actinic-keratosis-outweigh-benefits_sv.pdf"}},
    {"id":"47531","name":"CHMP post-authorisation summary of positive opinion for Braftovi (WS-1695)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T14:10:00Z","last_updated_date":"2020-04-30T14:10:00Z","reference_number":"EMA/CHMP/217942/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-braftovi-ws-1695_en.pdf"},
    {"id":"47532","name":"Risks of Picato for actinic keratosis outweigh benefits","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-30T18:00:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/228384/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/risks-picato-actinic-keratosis-outweigh-benefits_en.pdf"},
    {"id":"47533","name":"CHMP post-authorisation summary of positive opinion for Harvoni (X-81)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T18:00:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/CHMP/54435/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-harvoni-x-81_en.pdf"},
    {"id":"47534","name":"CHMP post-authorisation summary of positive opinion for Taltz (II-30)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T15:32:00Z","last_updated_date":"2020-04-30T15:32:00Z","reference_number":"EMA/178688/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-taltz-ii-30_en.pdf"},
    {"id":"47535","name":"EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-30T15:43:00Z","last_updated_date":"2020-04-30T15:43:00Z","reference_number":"EMA/229267/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/ema-recommendations-dpd-testing-prior-treatment-fluorouracil-capecitabine-tegafur-and-flucytosine_en.pdf"},
    {"id":"47536","name":"CHMP post-authorisation summary of positive opinion for Kalydeco (II-82)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T18:00:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/207923/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kalydeco-ii-82_en.pdf"},
    {"id":"47537","name":"First triple combination therapy for asthma with optional electronic sensor","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-30T16:07:00Z","last_updated_date":"2020-04-30T16:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-triple-combination-therapy-asthma-optional-electronic-sensor_en.pdf"},
    {"id":"47538","name":"CHMP post-authorisation summary of positive opinion for Carmustine Obvius (II-02)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-04-30T18:00:00Z","last_updated_date":"2020-04-30T18:00:00Z","reference_number":"EMA/CHMP/212192/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-carmustine-obvius-ii-02_en.pdf"},
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    {"id":"47540","name":"Fluorouracil and fluorouracil related substances Article 31 referral - EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and 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    {"id":"47547","name":"Suspension of ranitidine medicines in the EU","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-30T16:40:00Z","last_updated_date":"2020-04-30T16:40:00Z","reference_number":"EMA/231394/2020 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/suspension-ranitidine-medicines-eu_en.pdf"},
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    {"id":"47550","name":"EU actions to support availability of medicines during COVID-19 pandemic - update #4","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-04-30T18:08:00Z","last_updated_date":"2020-04-30T18:08:00Z","reference_number":"EMA/235997/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/eu-actions-support-availability-medicines-during-covid-19-pandemic-update-4_en.pdf"},
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    {"id":"47789","name":"Draft list of references supporting the assessment of Species sedativae","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2020-05-29T02:00:00Z","last_updated_date":"2020-05-29T02:00:00Z","reference_number":"EMA/HMPC/735707/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-species-sedativae_en.pdf"},
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    {"id":"47796","name":"Draft list of references supporting the assessment of Species amarae","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2020-05-28T14:45:00Z","last_updated_date":"2020-05-28T14:45:00Z","reference_number":"EMA/HMPC/97854/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-species-amarae_en.pdf"},
    {"id":"47798","name":"Draft assessment report on Species amarae","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2020-05-28T14:45:00Z","last_updated_date":"2020-05-28T14:45:00Z","reference_number":"EMA/HMPC/749723/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-species-amarae_en.pdf"},
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    {"id":"47802","name":"IV Zanamivir compassionate-use programme - Closure of programme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/iv-zanamivir-compassionate-use-programme-closure-programme_en.pdf"},
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    {"id":"47805","name":"Public statement on IV Zanamivir - Closure of compassionate-use programme in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-iv-zanamivir-closure-compassionate-use-programme-european-union_en.pdf"},
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    {"id":"47807","name":"CHMP summary of positive opinion for Piqray","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"EMA/CHMP/266002/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-piqray_en.pdf"},
    {"id":"47808","name":"CHMP post-authorisation summary of positive opinion for Lynparza (II-33)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"EMA/CHMP/282935/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lynparza-ii-33_en.pdf"},
    {"id":"47809","name":"Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-05-28T17:26:00Z","last_updated_date":"2020-05-28T17:26:00Z","reference_number":"EMA/289945/2020 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/global-regulators-work-towards-alignment-policy-approaches-and-regulatory-flexibility-during-covid-19-update-3_en.pdf"},
    {"id":"47810","name":"CHMP summary of positive opinion for Zercepac","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T17:40:00Z","last_updated_date":"2020-05-29T17:40:00Z","reference_number":"EMA/CHMP/251510/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zercepac_en.pdf"},
    {"id":"47811","name":"Questions and answers on the use of Vokanamet in diabetic kidney disease","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-06-02T08:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-use-vokanamet-diabetic-kidney-disease_en.pdf"},
    {"id":"47812","name":"CHMP post-authorisation summary of positive opinion for Sivextro (II-35)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"EMA/CHMP/269339/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sivextro-ii-35_en.pdf"},
    {"id":"47817","name":"Questions and answers on the use of Trumenba in children between 1 and 9 years of age","type":"medicine-qa","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"EMA/147694/2020 ","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-use-trumenba-children-between-1-and-9-years-age_en.pdf"},
    {"id":"47818","name":"Draft assessment report on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2020-05-29T11:30:00Z","last_updated_date":"2020-05-29T11:30:00Z","reference_number":"EMA/HMPC/376761/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-aloysia-citrodora-palau-syn-aloysia-triphylla-lher-kuntze-verbena-triphylla-lher-lippia-citriodora-kunth-folium_en.pdf"},
    {"id":"47819","name":"Draft list of references supporting the assessment of Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2020-05-29T02:00:00Z","last_updated_date":"2020-05-29T02:00:00Z","reference_number":"EMA/HMPC/643161/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-aloysia-citrodora-palau-syn-aloysia-triphylla-lher-kuntze-verbena-triphylla-lher-lippia-citriodora-kunth-folium_en.pdf"},
    {"id":"47821","name":"CHMP summary of positive opinion for Xenleta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T11:38:00Z","last_updated_date":"2020-05-29T11:38:00Z","reference_number":"EMA/CHMP/265461/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-xenleta_en.pdf"},
    {"id":"47822","name":"New vaccine for prevention of Ebola virus disease recommended for approval in the European Union","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T12:00:00Z","last_updated_date":"2020-05-29T12:00:00Z","reference_number":"EMA/CHMP/282251/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/new-vaccine-prevention-ebola-virus-disease-recommended-approval-european-union_en.pdf"},
    {"id":"47823","name":"CHMP summary of positive opinion for Hepcludex","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T11:43:00Z","last_updated_date":"2020-05-29T11:43:00Z","reference_number":"EMA/CHMP/270357/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hepcludex_en.pdf"},
    {"id":"47824","name":"List of references of observational studies of chloroquine and hydroxychloroquine in COVID-19 patients","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T14:00:00Z","last_updated_date":"2020-06-05T16:13:00Z","reference_number":"EMA/295370/2020 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/list-references-observational-studies-chloroquine-and-hydroxychloroquine-covid-19-patients_en.pdf"},
    {"id":"47825","name":"European Medicines Agency response to IQWIG on transparency of COVID-19 related activities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T14:15:00Z","last_updated_date":"2020-05-29T14:15:00Z","reference_number":"EMA/280976/2020","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-response-iqwig-transparency-covid-19-related-activities_en.pdf"},
    {"id":"47826","name":"COVID-19: reminder of the risks of chloroquine and hydroxychloroquine","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-05-29T14:17:00Z","last_updated_date":"2020-05-29T14:17:00Z","reference_number":"EMA/282511/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/covid-19-reminder-risks-chloroquine-and-hydroxychloroquine_en.pdf"},
    {"id":"47833","name":"Minutes of the 107th meeting of the Management Board: 19 March 2020","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2020-05-29T17:07:00Z","last_updated_date":"2020-05-29T17:07:00Z","reference_number":"EMA/MB/152592/2020","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-107th-meeting-management-board-19-march-2020_en.pdf"},
    {"id":"47837","name":"FDA / EMA common commentary on submitting an initial paediatric study plan (iPSP) and paediatric investigation plan (PIP) for the prevention and treatment of COVID-19","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-06-02T18:25:00Z","last_updated_date":"2020-06-02T18:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/fda-ema-common-commentary-submitting-initial-paediatric-study-plan-ipsp-and-paediatric-investigation-plan-pip-prevention-and-treatment-covid-19_en.pdf"},
    {"id":"47838","name":"Direct healthcare professional communication (DHPC): Tepadina (thiotepa) 100 mg: possible risk of defective vials in batches n°1709192/1, n°1709192/2 and n°1709192/3 presenting a crimp seal not properly fixed on the vial","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-02T12:02:00Z","last_updated_date":"2020-06-02T12:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-tepadina-thiotepa-100-mg-possible-risk-defective-vials-batches-ndeg17091921-ndeg17091922-and-ndeg17091923-presenting-crimp-seal-not-properly-fixed_en.pdf"},
    {"id":"47840","name":"Public statement on Helixate NexGen: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-06-02T18:06:00Z","last_updated_date":"2020-06-02T18:06:00Z","reference_number":"EMA/171441/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-helixate-nexgen-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"47851","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T14:50:00Z","last_updated_date":"2020-06-04T14:50:00Z","reference_number":"EMA/249657/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-april-2020_en.pdf"},
    {"id":"47852","name":"Presentation - 2.1 ICH E6 R3 Expert Working Group Perspectives (R. Stanbrook)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:06:00Z","last_updated_date":"2020-06-04T15:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-21-ich-e6-r3-expert-working-group-perspectives-r-stanbrook_en.pdf"},
    {"id":"47853","name":"Presentation - 3.1 A flavour of patients’ organisations views on ICH E6 guidelines (F. Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:08:00Z","last_updated_date":"2020-06-04T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-31-flavour-patients-organisations-views-ich-e6-guidelines-f-houyez_en.pdf"},
    {"id":"47854","name":"Presentation - 3.1 Patient perspective on renovation of ICH guideline on GCP in clinical trials (M. Greco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:09:00Z","last_updated_date":"2020-06-04T15:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-31-patient-perspective-renovation-ich-guideline-gcp-clinical-trials-m-greco_en.pdf"},
    {"id":"47855","name":"Presentation - 3.2.1 Good Clinical Practice: patient centered, investigator friendly (M. Dreyling)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:15:00Z","last_updated_date":"2020-06-04T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-321-good-clinical-practice-patient-centered-investigator-friendly-m-dreyling_en.pdf"},
    {"id":"47856","name":"Presentation - 3.2.2 ICH E6: Good Clinical Practice stick to the principles (M. Landray)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:17:00Z","last_updated_date":"2020-06-04T15:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-322-ich-e6-good-clinical-practice-stick-principles-m-landray_en.pdf"},
    {"id":"47857","name":"Presentation - 3.2.3 ICH guideline renovation clinical researchers perspectives: ECRIN (J. Demotes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:19:00Z","last_updated_date":"2020-06-04T15:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-323-ich-guideline-renovation-clinical-researchers-perspectives-ecrin-j-demotes_en.pdf"},
    {"id":"47858","name":"Presentation - 3.2.4 ICH GCP Stakeholder workshop: European Organisation for Research and Treatment of Cancer (EORTC) perspective (D. Lacombe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:21:00Z","last_updated_date":"2020-06-04T15:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-324-ich-gcp-stakeholder-workshop-european-organisation-research-and-treatment-cancer-eortc-perspective-d-lacombe_en.pdf"},
    {"id":"47859","name":"Presentation - 1.1 Introduction to the ICH guideline development process (L. Lindstrom, M. Bonelli, E. Szepessy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:26:00Z","last_updated_date":"2020-06-04T15:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11-introduction-ich-guideline-development-process-l-lindstrom-m-bonelli-e-szepessy_en.pdf"},
    {"id":"47862","name":"Presentation - 1.2 Introduction to ICH E6(R3) and stakeholder engagement plan (L. Bregnhøj, F. Sweeney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:28:00Z","last_updated_date":"2020-06-04T15:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-12-introduction-ich-e6r3-and-stakeholder-engagement-plan-l-bregnhoj-f-sweeney_en.pdf"},
    {"id":"47863","name":"Presentation - 1.3 ICH E6 findings from Clinical Trials Transformation Initiative (CTTI) (P. Tenaerts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-04T15:30:00Z","last_updated_date":"2020-06-04T15:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-13-ich-e6-findings-clinical-trials-transformation-initiative-ctti-p-tenaerts_en.pdf"},
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    {"id":"48041","name":"Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201910","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-06-17T15:31:00Z","last_updated_date":"2020-06-17T15:31:00Z","reference_number":"EMA/329588/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/isoflurane-list-nationally-authorised-medicinal-products-psusa00001786201910_en.pdf"},
    {"id":"48042","name":"Withdrawal assessment report for Fingolimod Mylan","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-06-17T16:40:00Z","last_updated_date":"2020-06-17T16:40:00Z","reference_number":"EMA/CHMP/267761/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-fingolimod-mylan_en.pdf"},
    {"id":"48043","name":"International regulators stress value of safe and effective vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T10:22:00Z","last_updated_date":"2020-06-18T10:22:00Z","reference_number":"EMA/328196/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/international-regulators-stress-value-safe-and-effective-vaccines_en.pdf"},
    {"id":"48044","name":"Fosfomycin Article-31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T09:42:00Z","last_updated_date":"2020-06-18T09:42:00Z","reference_number":"EMA/229801/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/fosfomycin-article-31-referral-assessment-report_en.pdf"},
    {"id":"48046","name":"Direct healthcare professional communication (DHPC): Suboxone sublingual tablets (buprenorphine / naloxone): inaccurate Braille information on the carton for HU/CZ/SK pack","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T10:30:00Z","last_updated_date":"2020-06-18T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-suboxone-sublingual-tablets-buprenorphine-naloxone-inaccurate-braille-information-carton-huczsk-pack_en.pdf"},
    {"id":"48047","name":"Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8mg vial: inconsistency in the Spanish language package leaflet","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T11:00:00Z","last_updated_date":"2020-06-18T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-myalepta-metreleptin-58mg-vial-inconsistency-spanish-language-package-leaflet_en.pdf"},
    {"id":"48048","name":"Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: inconsistency in the Portuguese-language package leaflet","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T11:03:00Z","last_updated_date":"2020-06-18T11:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-myalepta-metreleptin-58-mg-vial-inconsistency-portuguese-language-package-leaflet_en.pdf"},
    {"id":"48049","name":"Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 3 mg vial: inconsistency in the Portuguese-language package leaflet","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T11:04:00Z","last_updated_date":"2020-06-18T11:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-myalepta-metreleptin-3-mg-vial-inconsistency-portuguese-language-package-leaflet_en.pdf"},
    {"id":"48050","name":"Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 3 mg vial: inconsistency in the Spanish language package leaflet (PL)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T11:05:00Z","last_updated_date":"2020-06-18T11:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-myalepta-metreleptin-3-mg-vial-inconsistency-spanish-language-package-leaflet-pl_en.pdf"},
    {"id":"48051","name":"Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: inconsistency in the English-language package leaflet (PL)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T11:06:00Z","last_updated_date":"2020-06-18T11:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-myalepta-metreleptin-58-mg-vial-inconsistency-english-language-package-leaflet-pl_en.pdf"},
    {"id":"48053","name":"Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-06-18T11:51:00Z","last_updated_date":"2020-06-18T11:51:00Z","reference_number":"EMA/331322/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/methoxyflurane-list-nationally-authorised-medicinal-products-psusa00010484201905_en.pdf-0"},
    {"id":"48056","name":"Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-19T14:00:00Z","last_updated_date":"2020-06-19T14:00:00Z","reference_number":"EMA/CVMP/302233/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/committee-medicinal-products-veterinary-use-cvmp-meeting-16-18-june-2020_en.pdf"},
    {"id":"48057","name":"Bupivacaine - Summary opinion of the CVMP on the establishment of maximum residue limits","type":"mrl-summary","status":"Adopted","consultation_date":"","first_published_date":"2020-06-19T13:54:00Z","last_updated_date":"2020-06-19T13:54:00Z","reference_number":"EMA/CVMP/278195/2020","document_url":"https://www.ema.europa.eu/en/documents/mrl-summary/bupivacaine-summary-opinion-cvmp-establishment-maximum-residue-limits_en.pdf"},
    {"id":"48058","name":"CVMP post-authorisation summary of positive opinion for Bluevac BTV","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-06-19T14:00:00Z","last_updated_date":"2020-06-19T14:00:00Z","reference_number":"EMA/CVMP/307513/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-bluevac-btv_en.pdf"},
    {"id":"48070","name":"European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"EMA/303870/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/european-regulators-make-recommendations-drawing-lessons-learnt-presence-nitrosamines-sartan-medicines_en.pdf"},
    {"id":"48071","name":"Lessons learnt from presence of N-nitrosamine impurities in sartan medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"EMA/526934/2019","document_url":"https://www.ema.europa.eu/en/documents/report/lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines_en.pdf"},
    {"id":"48076","name":"Presentation - Background on cases of sartanswith N-nitrosamine impurities (A. Spinei)","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/press-release/presentation-background-cases-sartanswith-n-nitrosamine-impurities-spinei_en.pdf"},
    {"id":"48077","name":"Presentation - Current analytical testing methodology and capacity (A. Teasdale)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-analytical-testing-methodology-and-capacity-teasdale_en.pdf"},
    {"id":"48078","name":"Presentation - Cohort of concern compounds–current guidance on impurities (especially genotoxic/ carcinogenic impurities) (A. Hartmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cohort-concern-compounds-current-guidance-impurities-especially-genotoxic-carcinogenic-impurities-hartmann_en.pdf"},
    {"id":"48079","name":"Presentation - Supply Chain Management and Surveillance (M. Wierer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supply-chain-management-and-surveillance-m-wierer_en.pdf"},
    {"id":"48080","name":"Presentation - What is the role of General Practitioners / Family Physicians in ARB recalls? (T. Villanueva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-role-general-practitioners-family-physicians-arb-recalls-t-villanueva_en.pdf"},
    {"id":"48081","name":"Overview of comments received on recommendations in report on lessons learnt from presence of N-nitrosamine impurities in sartan medicines","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"EMA/326173/2020","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-recommendations-report-lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines_en.pdf"},
    {"id":"48082","name":"Presentation - ICH M7 Principles -Impurity Identification and Control (R. Ogilvie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-m7-principles-impurity-identification-and-control-r-ogilvie_en.pdf"},
    {"id":"48083","name":"Presentation - Prevention of contamination with nitrosamine impurities (B. Hirschlerová)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prevention-contamination-nitrosamine-impurities-b-hirschlerova_en.pdf"},
    {"id":"48084","name":"Presentation - Patients‘ concerns and reactions to Sartans with N-nitrosamine impurities (C. Dehn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-concerns-and-reactions-sartans-n-nitrosamine-impurities-c-dehn_en.pdf"},
    {"id":"48085","name":"Presentation - Information, coordination and public communication (L. Tonel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-coordination-and-public-communication-l-tonel_en.pdf"},
    {"id":"48086","name":"Presentation - Experiences from the Belgian & European Community Pharmacists Associations on the communication of the sartansrecall in 2018 (B. Machlien)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experiences-belgian-european-community-pharmacists-associations-communication-sartansrecall-2018-b-machlien_en.pdf"},
    {"id":"48088","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T13:17:00Z","last_updated_date":"2020-06-23T13:17:00Z","reference_number":"EMA/298881/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-may-2020_en.pdf"},
    {"id":"48089","name":"Presentation - Information, coordination and public communication (N. Mbaeliachi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-coordination-and-public-communication-n-mbaeliachi_en.pdf"},
    {"id":"48090","name":"Presentation - Recall and supply chain traceability (L.Paulo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recall-and-supply-chain-traceability-lpaulo_en.pdf"},
    {"id":"48091","name":"Presentation - Incident Management (K. O'Donnell)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-incident-management-k-odonnell_en.pdf"},
    {"id":"48092","name":"Presentation - Sartan Case Study- Session 4: Prevention Part II (A. Teasdale)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sartan-case-study-session-4-prevention-part-ii-teasdale_en.pdf"},
    {"id":"48094","name":"Presentation - Regulatory, Manufacturing and Supply Chain Aspects (M. Senis, J. M. de Ciura)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:00:00Z","last_updated_date":"2020-06-23T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-manufacturing-and-supply-chain-aspects-m-senis-j-m-de-ciura_en.pdf"},
    {"id":"48095","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 3 of Addendum I of Module VIII on requirements and recommendations for the submission of information (2020)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T14:05:00Z","last_updated_date":"2020-06-23T14:05:00Z","reference_number":"EMA/261052/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-revision-3-addendum-i-module-viii-requirements-and-recommendations-submission-information-2020_en.pdf"},
    {"id":"48096","name":"Guideline on good pharmacovigilance practices (GVP): Module VIII Addendum I - Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 3)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-06-23T14:17:00Z","last_updated_date":"2020-06-23T14:17:00Z","reference_number":"EMA/395730/2012 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-viii-addendum-i-requirements-and-recommendations-submission-information-non-interventional-post-authorisation-safety-studies-rev-3_en.pdf"},
    {"id":"48101","name":"Development of regulatory science strategy to 2025","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2020-06-23T15:43:00Z","last_updated_date":"2020-06-23T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/development-regulatory-science-strategy-2025_en.pdf"},
    {"id":"48102","name":"CHMP post-authorisation summary of positive opinion for Zavicefta (II-19)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-06-26T09:46:00Z","last_updated_date":"2020-06-26T09:46:00Z","reference_number":"EMA/CHMP/312635/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zavicefta-ii-19_en.pdf"},
    {"id":"48103","name":"Veklury - Product Information as approved by the CHMP on 25 June 2020, pending endorsement by the European Commission","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-06-25T14:00:00Z","last_updated_date":"2020-06-25T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/veklury-product-information-approved-chmp-25-june-2020-pending-endorsement-european-commission_en.pdf"},
    {"id":"48104","name":"Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-24T12:30:00Z","last_updated_date":"2020-06-24T12:30:00Z","reference_number":"EMA/338758/2020 ","document_url":"https://www.ema.europa.eu/en/documents/press-release/global-regulators-discuss-data-requirements-phase-3-trials-covid-19-vaccines_en.pdf"},
    {"id":"48106","name":"Deferasirox Mylan: Measures to avoid medication errors","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2020-06-24T14:25:00Z","last_updated_date":"2020-06-24T14:25:00Z","reference_number":"EMA/64561/2020","document_url":"https://www.ema.europa.eu/en/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_da.pdf","de":"https://www.ema.europa.eu/de/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_de.pdf","et":"https://www.ema.europa.eu/et/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_et.pdf","el":"https://www.ema.europa.eu/el/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medication-error/deferasirox-mylan-measures-avoid-medication-errors_sv.pdf"}},
    {"id":"48113","name":"Withdrawal assessment report for Rituximab Mabion","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-06-24T16:44:00Z","last_updated_date":"2020-06-24T16:44:00Z","reference_number":"EMA/CHMP/141953/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-rituximab-mabion_en.pdf"},
    {"id":"48117","name":"Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary training course (September, October, November, December 2020)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-06-25T10:20:00Z","last_updated_date":"2020-09-03T09:38:00Z","reference_number":"Course #20582, #20583, #20579, #20584","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-training-course-september-october-november-december-2020_en.pdf"},
    {"id":"48118","name":"Agenda - Extraordinary Management Board meeting to nominate a new EMA Executive Director: 25 June 2020","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2020-06-25T10:38:00Z","last_updated_date":"2020-06-25T11:23:00Z","reference_number":"EMA/MB/238692/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-extraordinary-management-board-meeting-nominate-new-ema-executive-director-25-june-2020_en.pdf"},
    {"id":"48120","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-06-25T11:34:00Z","last_updated_date":"2020-06-25T11:34:00Z","reference_number":"EMA/CAT/159950/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-march-2020_en.pdf"},
    {"id":"48121","name":"Appointment of EMA Executive Director - The process","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-06-25T11:43:00Z","last_updated_date":"2020-07-15T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/appointment-ema-executive-director-process_en.pdf"},
    {"id":"48122","name":"CHMP summary of positive opinion for Veklury","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-06-25T14:00:00Z","last_updated_date":"2020-06-25T14:00:00Z","reference_number":"EMA/CHMP/311506/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-veklury_en.pdf"},
    {"id":"48123","name":"First COVID-19 treatment recommended for EU authorisation","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-25T13:36:00Z","last_updated_date":"2020-06-25T13:36:00Z","reference_number":"EMA/264817/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/first-covid-19-treatment-recommended-eu-authorisation_en.pdf"},
    {"id":"48126","name":"CHMP summary of positive opinion for Methylthioninium chloride Cosmo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-06-26T12:00:00Z","last_updated_date":"2020-06-26T12:00:00Z","reference_number":"EMA/CHMP/313588/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-methylthioninium-chloride-cosmo_en.pdf"},
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    {"id":"48162","name":"Agenda - ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-07-02T10:30:00Z","last_updated_date":"2020-08-25T11:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-isoich-e2br3-individual-case-safety-report-icsr-eu-virtual-live-hands-training-course-using-eudravigilance-system_en.pdf"},
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    {"id":"48194","name":"International regulators provide guiding principles for COVID-19 clinical trials","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-07-01T14:50:00Z","last_updated_date":"2020-07-01T14:50:00Z","reference_number":"EMA/347443/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/international-regulators-provide-guiding-principles-covid-19-clinical-trials_en.pdf"},
    {"id":"48195","name":"Overview of comments received on 'Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation' (EMA/CHMP/458101/2016)","type":"comments","status":"Adopted","consultation_date":"","first_published_date":"2020-07-01T12:16:00Z","last_updated_date":"2020-07-01T12:16:00Z","reference_number":"EMA/CHMP/59169/2017","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-qualification-and-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-and-simulation-emachmp4581012016_en.pdf"},
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    {"id":"48352","name":"Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201911","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-07-22T10:00:00Z","last_updated_date":"2020-07-22T10:00:00Z","reference_number":"EMA/385380/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/chloroquine-phosphate-proguanil-hydrochloride-list-nationally-authorised-medicinal-products-psusa00010207201911_en.pdf"},
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    {"id":"48408","name":"CHMP summary of positive opinion for Jyseleca","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T14:06:00Z","last_updated_date":"2020-07-24T14:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-jyseleca_en.pdf"},
    {"id":"48409","name":"Questions and answers on the refusal of the marketing authorisation for Gamifant (emapalumab)","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2020-07-24T14:33:00Z","last_updated_date":"2021-03-19T02:00:00Z","reference_number":"EMA/601716/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-gamifant-emapalumab_sv.pdf"}},
    {"id":"48411","name":"Horse-chestnut seed: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2020-07-24T09:58:00Z","last_updated_date":"2020-07-24T09:58:00Z","reference_number":"EMA/60766/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/horse-chestnut-seed-summary-public_en.pdf"},
    {"id":"48412","name":"European Union list entry on Mentha x piperita L., aetheroleum - Revision 1","type":"herbal-list-entry","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T15:43:00Z","last_updated_date":"2020-07-24T15:43:00Z","reference_number":"EMA/HMPC/679997/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/european-union-list-entry-mentha-x-piperita-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48413","name":"European Union herbal monograph on Mentha x piperita L., aetheroleum - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T08:47:00Z","last_updated_date":"2020-07-24T08:47:00Z","reference_number":"EMA/HMPC/522410/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/european-union-herbal-monograph-mentha-x-piperita-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48414","name":"Assessment report on Mentha x piperita L., folium and aetheroleum - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T15:48:00Z","last_updated_date":"2020-07-24T15:48:00Z","reference_number":"EMA/HMPC/522409/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/assessment-report-mentha-x-piperita-l-folium-and-aetheroleum-revision-1_en.pdf"},
    {"id":"48415","name":"List of references supporting the assessment of Mentha x piperita L., folium and aetheroleum - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T08:47:00Z","last_updated_date":"2020-07-24T08:47:00Z","reference_number":"EMA/HMPC/522408/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-mentha-x-piperita-l-folium-and-aetheroleum-revision-1_en.pdf"},
    {"id":"48416","name":"Opinion of the HMPC on changes to be introduced into an entry in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products - Mentha x piperita L., aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T08:47:00Z","last_updated_date":"2020-07-24T08:47:00Z","reference_number":"EMA/HMPC/229263/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-changes-be-introduced-entry-list-herbal-substances-preparations-and-combinations-thereof-use-traditional-herbal-medicinal-products-mentha-x-piperita-l-aetheroleum_en.pdf"},
    {"id":"48417","name":"Opinion of the HMPC on a European Union herbal monograph on Mentha x piperita L., aetheroleum - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T01:00:00Z","last_updated_date":"2020-07-24T01:00:00Z","reference_number":"EMA/HMPC/22236/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-mentha-x-piperita-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48419","name":"European Union herbal monograph on Mentha x piperita L., folium - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T16:08:00Z","last_updated_date":"2020-07-24T16:08:00Z","reference_number":"EMA/HMPC/572705/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/european-union-herbal-monograph-mentha-x-piperita-l-folium-revision-1_en.pdf"},
    {"id":"48420","name":"Opinion of the HMPC on a European Union herbal monograph on Mentha x piperita L., folium - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T16:09:00Z","last_updated_date":"2020-07-24T16:09:00Z","reference_number":"EMA/HMPC/226633/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-mentha-x-piperita-l-folium-revision-1_en.pdf"},
    {"id":"48422","name":"Final assessment report on Rhamnus purshiana DC., cortex - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-07-27T09:48:00Z","last_updated_date":"2020-07-27T09:48:00Z","reference_number":"EMA/HMPC/909434/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-rhamnus-purshiana-dc-cortex-revision-1_en.pdf"},
    {"id":"48423","name":"Final list of references supporting the assessment of Rhamnus purshiana DC., cortex - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2020-07-27T09:50:00Z","last_updated_date":"2020-07-27T09:50:00Z","reference_number":"EMA/HMPC/14806/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-rhamnus-purshiana-dc-cortex-revision-1_en.pdf"},
    {"id":"48424","name":"Final European Union herbal monograph on Rhamnus purshiana DC., cortex - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2020-07-27T09:52:00Z","last_updated_date":"2020-07-27T09:52:00Z","reference_number":"EMA/HMPC/726270/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-rhamnus-purshiana-dc-cortex-revision-1_en.pdf"},
    {"id":"48425","name":"Final opinion of the HMPC on a European Union herbal monograph on Rhamnus purshiana DC., cortex - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2020-07-27T10:04:00Z","last_updated_date":"2020-07-27T10:04:00Z","reference_number":"EMA/HMPC/254847/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-rhamnus-purshiana-dc-cortex-revision-1_en.pdf"},
    {"id":"48426","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-07-27T11:33:00Z","last_updated_date":"2020-07-27T11:33:00Z","reference_number":"EMA/CAT/399507/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-july-2020_en.pdf"},
    {"id":"48427","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-07-27T11:39:00Z","last_updated_date":"2020-07-27T11:39:00Z","reference_number":"EMA/355313/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-june-2020_en.pdf"},
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    {"id":"48430","name":"Opium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"48626","name":"EU/3/20/2276: Public summary of opinion on orphan designation: Methotrexate for the treatment of retinal detachment","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T11:01:00Z","last_updated_date":"2020-08-19T11:01:00Z","reference_number":"EMADOC-628903358-2378","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202276-public-summary-opinion-orphan-designation-methotrexate-treatment-retinal-detachment_en.pdf"},
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    {"id":"48628","name":"EU/3/20/2278: Public summary of opinion on orphan designation:Rilzabrutinib for the treatment of immune thrombocytopenia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T11:50:00Z","last_updated_date":"2020-08-19T11:50:00Z","reference_number":"EMADOC-628903358-2371","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202278-public-summary-opinion-orphan-designationrilzabrutinib-treatment-immune-thrombocytopenia_en.pdf"},
    {"id":"48629","name":"EU/3/20/2279 : Public summary of opinion on orphan designation: Lumacaftor for the treatment of non-traumatic subarachnoid haemorrhage","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T12:04:00Z","last_updated_date":"2020-08-19T12:04:00Z","reference_number":"EMADOC-628903358-2372","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202279-public-summary-opinion-orphan-designation-lumacaftor-treatment-non-traumatic-subarachnoid-haemorrhage_en.pdf"},
    {"id":"48631","name":"EU/3/20/2280: Public summary of opinion on orphan designation: Lutetium (177Lu) lilotomab satetraxetan for the treatment of marginal zone lymphoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T12:41:00Z","last_updated_date":"2020-08-19T12:41:00Z","reference_number":"EMADOC-628903358-2370","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202280-public-summary-opinion-orphan-designation-lutetium-177lu-lilotomab-satetraxetan-treatment-marginal-zone-lymphoma_en.pdf"},
    {"id":"48632","name":"EU/3/20/2281: Public summary of opinion on orphan designation: (4-{(2S,4S)-4-Ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)) for the treatment of paroxysmal nocturnal haemoglobinuria","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T12:51:00Z","last_updated_date":"2020-08-19T12:51:00Z","reference_number":"EMADOC-628903358-2373","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202281-public-summary-opinion-orphan-designation-4-2s4s-4-ethoxy-1-5-methoxy-7-methyl-1h-indol-4-ylmethylpiperidin-2-ylbenzoic-acid-hydrogen-chloride11-treatment-paroxysmal-nocturnal_en.pdf"},
    {"id":"48633","name":"EU/3/20/2282 : Public summary of opinion on orphan designation: Viltolarsen for the treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T13:07:00Z","last_updated_date":"2020-08-19T13:07:00Z","reference_number":"EMADOC-628903358-2374","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202282-public-summary-opinion-orphan-designation-viltolarsen-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"48634","name":"Withdrawal assessment report for Xiidra","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T17:13:00Z","last_updated_date":"2020-08-19T17:13:00Z","reference_number":"EMA/334174/2020 ","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-xiidra_en.pdf"},
    {"id":"48635","name":"Final European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T14:43:00Z","last_updated_date":"2020-08-19T14:43:00Z","reference_number":"EMA/HMPC/554043/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-herniaria-glabra-l-h-hirsuta-l-h-incana-lam-herba_en.pdf"},
    {"id":"48636","name":"Final assessment report on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T14:46:00Z","last_updated_date":"2020-08-19T14:46:00Z","reference_number":"EMA/HMPC/554033/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-herniaria-glabra-l-h-hirsuta-l-h-incana-lam-herba_en.pdf"},
    {"id":"48637","name":"Final list of references supporting the assessment of Herniaria glabra L., H. hirsuta L., H. incana Lam., herba","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T14:47:00Z","last_updated_date":"2020-08-19T14:47:00Z","reference_number":"EMA/HMPC/554034/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-herniaria-glabra-l-h-hirsuta-l-h-incana-lam-herba_en.pdf"},
    {"id":"48638","name":"Opinion of the HMPC on a European Union herbal monograph on Herniariae glabra L.; Herniariae hirsuta L.; Herniariae incana Lam., herba","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T14:49:00Z","last_updated_date":"2020-08-19T14:49:00Z","reference_number":"EMA/HMPC/378594/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-herniariae-glabra-l-herniariae-hirsuta-l-herniariae-incana-lam-herba_en.pdf"},
    {"id":"48639","name":"Overview of comments received on European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T14:50:00Z","last_updated_date":"2020-08-19T14:50:00Z","reference_number":"EMA/HMPC/229208/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-herniaria-glabra-l-h-hirsuta-l-h-incana-lam-herba_en.pdf"},
    {"id":"48640","name":"EU/3/20/2283: Public summary of opinion on orphan designation: Ile-Ala-Leu-Ile-Leu-Glu-Pro-Ile-Cys-Cys-Gln-Glu-Arg-Ala-Ala-(discrete-polyethylene glycol)24 for the treatment of neonatal encephalopathy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T17:38:00Z","last_updated_date":"2020-08-19T17:38:00Z","reference_number":"EMADOC-628903358-2375","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202283-public-summary-opinion-orphan-designation-ile-ala-leu-ile-leu-glu-pro-ile-cys-cys-gln-glu-arg-ala-ala-discrete-polyethylene-glycol24-treatment-neonatal-encephalopathy_en.pdf"},
    {"id":"48641","name":"EU/3/20/2284: Public summary of opinion on orphan designation: Sodium phenylbutyrate, tauroursodeoxycholic acid for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T17:51:00Z","last_updated_date":"2020-08-19T17:51:00Z","reference_number":"EMADOC-628903358-2376","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202284-public-summary-opinion-orphan-designation-sodium-phenylbutyrate-tauroursodeoxycholic-acid-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"48642","name":"EU/3/20/2285 : Public summary of opinion on orphan designation: 1-((2S,4S)-2-((((S)-(4-Bromophenoxy)(((S)-1-oxo-1-(((S)-pentan-2-yl)oxy)propan-2-yl)amino)phosphoryl)oxy)methyl)-1,3-dioxolan-4-yl)-2-oxo-1,2-dihydropyrimidin-4-aminium chloride for the treat","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T18:03:00Z","last_updated_date":"2020-08-19T18:03:00Z","reference_number":"EMADOC-628903358-2379","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202285-public-summary-opinion-orphan-designation-1-2s4s-2-s-4-bromophenoxys-1-oxo-1-s-pentan-2-yloxypropan-2-ylaminophosphoryloxymethyl-13-dioxolan-4-yl-2-oxo-12-dihydropyrimidin-4-aminium-chloride_en.pdf"},
    {"id":"48643","name":"EU/3/20/2286: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells transduced with a lentiviral vector encoding an affinity enhanced T cell receptor specific to MAGE-A4 for the treatment of soft tissue sarcoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T18:14:00Z","last_updated_date":"2020-08-19T18:14:00Z","reference_number":"EMADOC-628903358-2380","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202286-public-summary-opinion-orphan-designation-autologous-cd4-and-cd8-t-cells-transduced-lentiviral-vector-encoding-affinity-enhanced-t-cell-receptor-specific-mage-a4-treatment-soft-tissue_en.pdf"},
    {"id":"48644","name":"EU/3/20/2287: Public summary of opinion on orphan designation: Adeno-associated virus serotype 9 containing the human ASPA gene for the treatment of Canavan disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2020-08-19T18:25:00Z","last_updated_date":"2020-08-19T18:25:00Z","reference_number":"EMADOC-628903358-2377","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202287-public-summary-opinion-orphan-designation-adeno-associated-virus-serotype-9-containing-human-aspa-gene-treatment-canavan-disease_en.pdf"},
    {"id":"48645","name":"Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated viral vector encoding the human cytochrome P450 21-hydroxylase gene","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235515/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adeno-associated-viral-vector-encoding-human-cytochrome-p450-21-hydroxylase-gene_en.pdf"},
    {"id":"48646","name":"Scientific recommendation on classification of advanced therapy medicinal products: Adeno-associated virus serotype 5 encoding human retinal guanylate cyclase 1 gene","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234887/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-adeno-associated-virus-serotype-5-encoding-human-retinal-guanylate-cyclase-1-gene_en.pdf"},
    {"id":"48647","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cultured postnatal thymus tissue-derived product","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/189324/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-cultured-postnatal-thymus-tissue-derived-product_en.pdf"},
    {"id":"48648","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic haematopoietic stem and progenitor cells treated ex vivo with a fusion protein","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/188546/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-haematopoietic-stem-and-progenitor-cells-treated-ex-vivo-fusion-protein_en.pdf"},
    {"id":"48649","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human Wharton’s jelly-derived mesenchymal stem cells seeded onto decellularized dermal scaffold","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/188455/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-human-whartons-jelly-derived-mesenchymal-stem-cells-seeded-decellularized-dermal-scaffold_en.pdf"},
    {"id":"48650","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic natural killer cells expanded in vitro","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/189175/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-natural-killer-cells-expanded-vitro_en.pdf"},
    {"id":"48651","name":"Scientific recommendation on classification of ATMP: Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+ progenitor cells, & allogeneic, non-expanded, umbilical cord blood-derived,haematopoietic mature myeloid & lymphoid cells","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235526/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-atmp-allogeneic-ex-vivo-expanded-umbilical-cord-blood-derived-haematopoietic-cd34-progenitor-cells-allogeneic-non-expanded-umbilical-cord-blood_en.pdf"},
    {"id":"48654","name":"European Medicines Agency privacy statement for EnprEMA network database","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2020-08-20T13:41:00Z","last_updated_date":"2020-08-20T13:41:00Z","reference_number":"EMA/461900/2019 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-privacy-statement-enprema-network-database_en.pdf"},
    {"id":"48655","name":"Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+ progenitor cells, and allogeneic, non-expanded, umbilical cord blood-derived...","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235526/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-allogeneic-ex-vivo-expanded-umbilical-cord-blood-derived-haematopoietic-cd34-progenitor-cells-and-allogeneic-non-expanded_en.pdf"},
    {"id":"48658","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous skeletal muscle derived cells attached to poly(DL-lactide-co-glycolide) microparticles","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235524/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-skeletal-muscle-derived-cells-attached-polydl-lactide-co-glycolide-microparticles_en.pdf"},
    {"id":"48659","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234878/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-viable-adipose-derived-regenerative-cells-extracted-human-subcutaneous-fat-liposuction-aspirates_en.pdf"},
    {"id":"48660","name":"Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 1)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234880/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-atmp-autologous-viable-adipose-derived-regenerative-cells-extracted-human-subcutaneous-fat-liposuction-aspirates-obtained-enzymatic-isolation-using-proprietary_en.pdf"},
    {"id":"48661","name":"Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 1)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234872/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-atmp-autologous-viable-adipose-derived-regenerative-cells-extracted-human-subcutaneous-fat-liposuction-aspirates-obtained-enzymatic-isolation-using-proprietary_en.pdf-0"},
    {"id":"48662","name":"Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 2)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T15:30:00Z","last_updated_date":"2020-08-20T15:30:00Z","reference_number":"EMA/234882/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-atmp-autologous-viable-adipose-derived-regenerative-cells-extracted-human-subcutaneous-fat-liposuction-aspirates-obtained-enzymatic-isolation-using-proprietary_en.pdf-1"},
    {"id":"48663","name":"Scientific recommendation on classification of ATMP: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates obtained by enzymatic isolation (using a proprietary system from manufacturer 2)","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T15:30:00Z","last_updated_date":"2020-08-20T15:30:00Z","reference_number":"EMA/234874/2019","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-atmp-autologous-viable-adipose-derived-regenerative-cells-extracted-human-subcutaneous-fat-liposuction-aspirates-obtained-enzymatic-isolation-using-proprietary_en.pdf-2"},
    {"id":"48664","name":"Scientific recommendation on classification of advanced therapy medicinal products: Autologous viable adipose-derived regenerative cells extracted from human subcutaneous fat from liposuction aspirates","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234869/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-viable-adipose-derived-regenerative-cells-extracted-human-subcutaneous-fat-liposuction-aspirates_en.pdf-0"},
    {"id":"48665","name":"Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose-derived stem cells","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234927/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-cultured-autologous-adipose-derived-stem-cells_en.pdf"},
    {"id":"48666","name":"Scientific recommendation on classification of advanced therapy medicinal products: DNA plasmid vector encoding human IL-12","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235535/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-dna-plasmid-vector-encoding-human-il-12_en.pdf"},
    {"id":"48667","name":"Scientific recommendation on classification of advanced therapy medicinal products: DNA delivery vector with similar structure-function than bacteriophage capsids","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/189107/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-dna-delivery-vector-similar-structure-function-bacteriophage-capsids_en.pdf"},
    {"id":"48668","name":"Scientific recommendation on classification of advanced therapy medicinal products: Ex-vivo expanded allogeneic bone marrow derived mesenchymal stromal cells","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235539/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-ex-vivo-expanded-allogeneic-bone-marrow-derived-mesenchymal-stromal-cells_en.pdf"},
    {"id":"48669","name":"Scientific recommendation on classification of advanced therapy medicinal products: Human bone marrow derived allogeneic mesenchymal stem cells expressing human alpha-1 antitrypsin","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/188494/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-human-bone-marrow-derived-allogeneic-mesenchymal-stem-cells-expressing-human-alpha-1-antitrypsin_en.pdf"},
    {"id":"48671","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated viral vector containing a human micro-dystrophin gene","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235532/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-viral-vector-containing-human-micro-dystrophin-gene_en.pdf"},
    {"id":"48672","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus (AAV), serotype 1 containing a transgene that encodes a microRNA targeting huntingtin messenger RNA","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/188618/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-virus-aav-serotype-1-containing-transgene-encodes-microrna-targeting-huntingtin-messenger-rna_en.pdf"},
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    {"id":"48769","name":"Minutes of the 108th meeting of the Management Board: 11 June 2020","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2020-09-09T09:00:00Z","last_updated_date":"2020-09-09T09:00:00Z","reference_number":"EMA/MB/318294/2020","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-108th-meeting-management-board-11-june-2020_en.pdf"},
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    {"id":"48772","name":"Human alpha1-proteinase inhibitor (apart from the centrally authorised product): List of nationally authorised medicinal products - PSUSA/00000108/201912","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-09T11:50:00Z","last_updated_date":"2020-09-09T11:50:00Z","reference_number":"EMA/351582/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-alpha1-proteinase-inhibitor-apart-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa00000108201912_en.pdf"},
    {"id":"48773","name":"Sodium benzoate / grindelia tincture / polygala syrup: List of nationally authorised medicinal products - PSUSA/00010543/201912","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-09T11:51:00Z","last_updated_date":"2020-09-09T11:51:00Z","reference_number":"EMA/453705/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-benzoate-grindelia-tincture-polygala-syrup-list-nationally-authorised-medicinal-products-psusa00010543201912_en.pdf"},
    {"id":"48777","name":"Agenda - CAT agenda of the 9-11 September 2020 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-09-10T10:37:00Z","last_updated_date":"2020-09-10T10:37:00Z","reference_number":"EMA/CAT/476108/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-9-11-september-2020-meeting_en.pdf"},
    {"id":"48778","name":"News bulletin for small and medium-sized enterprises - Issue 50","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2020-09-10T12:12:00Z","last_updated_date":"2020-09-10T12:12:00Z","reference_number":"Issue 50","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-50_en.pdf"},
    {"id":"48783","name":"Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T11:29:00Z","last_updated_date":"2020-09-11T11:29:00Z","reference_number":"EMA/472025/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/landiolol-list-nationally-authorised-medicinal-products-psusa00010570202002_en.pdf"},
    {"id":"48784","name":"Alitretinoin (oral use): List of nationally authorised medicinal products - PSUSA/00010710/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T11:32:00Z","last_updated_date":"2020-09-11T11:32:00Z","reference_number":"EMA/472049/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/alitretinoin-oral-use-list-nationally-authorised-medicinal-products-psusa00010710202001_en.pdf"},
    {"id":"48785","name":"Celiprolol: List of nationally authorised medicinal products - PSUSA/00000617/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T11:32:00Z","last_updated_date":"2020-09-11T11:32:00Z","reference_number":"EMA/PRAC/473760/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/celiprolol-list-nationally-authorised-medicinal-products-psusa00000617202001_en.pdf"},
    {"id":"48786","name":"Omega-3-acid ethyl esters: List of nationally authorised medicinal products - PSUSA/00010312/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T11:32:00Z","last_updated_date":"2020-09-11T11:32:00Z","reference_number":"EMA/474212/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/omega-3-acid-ethyl-esters-list-nationally-authorised-medicinal-products-psusa00010312202001_en.pdf"},
    {"id":"48787","name":"Metamizole sodium / triacetonamine tosilate: List of nationally authorised medicinal products - PSUSA/00001999/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T11:32:00Z","last_updated_date":"2020-09-11T11:32:00Z","reference_number":"EMA/470386/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-sodium-triacetonamine-tosilate-list-nationally-authorised-medicinal-products-psusa00001999202001_en.pdf"},
    {"id":"48788","name":"Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L. (sublingual tablet): List of nationally authorised medicinal products - PSUSA/00010465/201912","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T11:32:00Z","last_updated_date":"2020-09-11T11:32:00Z","reference_number":"EMA/470436/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-therapy-dactylis-glomerata-l-phleum-pratense-l-anthoxanthum-odoratum-l-lolium-perenne-l-poa-pratensis-l-sublingual-tablet-list-nationally-authorised-medicinal-products-psusa00010465201912_en.pdf"},
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    {"id":"48794","name":"Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-09-11T12:45:00Z","last_updated_date":"2020-09-11T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-prevymis-letermovir-concentrate-solution-infusion-essential-administer-through-sterile-02-micron-or-022-micron-polyethersulfone-pes-line-filter_en.pdf"},
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    {"id":"48797","name":"CVMP post-authorisation summary of positive opinion for Cytopoint (II-0009)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-09-11T15:00:00Z","last_updated_date":"2020-09-11T15:00:00Z","reference_number":"EMA/CVMP/446877/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-cytopoint-ii-0009_en.pdf"},
    {"id":"48808","name":"Lidocaine / phenazone: List of nationally authorised medicinal products - PSUSA/00002359/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-14T15:48:00Z","last_updated_date":"2020-09-14T15:48:00Z","reference_number":"EMA/470429/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-phenazone-list-nationally-authorised-medicinal-products-psusa00002359202001_en.pdf"},
    {"id":"48809","name":"Cyanocobalamin / diclofenac / pyridoxine / thiamine: List of nationally authorised medicinal products - PSUSA/00001041/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-14T15:48:00Z","last_updated_date":"2020-09-14T15:48:00Z","reference_number":"EMA/476702/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyanocobalamin-diclofenac-pyridoxine-thiamine-list-nationally-authorised-medicinal-products-psusa00001041202001_en.pdf"},
    {"id":"48810","name":"Tizanidine: List of nationally authorised medicinal products - PSUSA/00002977/201912","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-14T15:48:00Z","last_updated_date":"2020-09-14T15:48:00Z","reference_number":"EMA/476734/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/tizanidine-list-nationally-authorised-medicinal-products-psusa00002977201912_en.pdf"},
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    {"id":"48858","name":"Ranitidine Article-31 referral - EMA confirms recommendation to suspend all ranitidine medicines in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-09-18T11:08:00Z","last_updated_date":"2020-09-18T11:08:00Z","reference_number":"EMA/666097/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ranitidine-article-31-referral-ema-confirms-recommendation-suspend-all-ranitidine-medicines-eu_sv.pdf"}},
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    {"id":"48862","name":"CHMP post-authorisation summary of positive opinion for Yervoy (WS-1783)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-09-18T12:57:00Z","last_updated_date":"2020-09-18T12:57:00Z","reference_number":"EMA/CHMP/451052/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yervoy-ws-1783_en.pdf"},
    {"id":"48866","name":"Beta-alanine: List of nationally authorised medicinal products - PSUSA/00010510/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-09-21T15:30:00Z","last_updated_date":"2020-09-21T15:30:00Z","reference_number":"EMA/475166/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/beta-alanine-list-nationally-authorised-medicinal-products-psusa00010510202001_en.pdf"},
    {"id":"48868","name":"COMP meeting report on the review of applications for orphan designation: September 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-09-21T15:38:00Z","last_updated_date":"2021-01-15T14:00:00Z","reference_number":"EMA/COMP/479534/2020 Corr.","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-september-2020_en.pdf"},
    {"id":"48869","name":"Final assessment report on Thymus vulgaris L., Thymus zygis L., aetheroleum - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-09-21T15:55:00Z","last_updated_date":"2020-09-21T15:55:00Z","reference_number":"EMA/HMPC/52980/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-thymus-vulgaris-l-thymus-zygis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48870","name":"Final European Union herbal monograph on Thymus vulgaris L., Thymus zygis L., aetheroleum - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2020-09-21T15:57:00Z","last_updated_date":"2020-09-21T15:57:00Z","reference_number":"EMA/HMPC/59032/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-thymus-vulgaris-l-thymus-zygis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48871","name":"Final List of references supporting the assessment of Thymus vulgaris L., Thymus zygis L., aetheroleum - Revision 1","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2020-09-21T15:59:00Z","last_updated_date":"2020-09-21T15:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-thymus-vulgaris-l-thymus-zygis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48872","name":"Opinion of the HMPC on a European Union herbal monograph on Thymus vulgaris L., Thymus zygis L., aetheroleum - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2020-09-21T16:00:00Z","last_updated_date":"2020-09-21T16:00:00Z","reference_number":"EMA/HMPC/394930/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-thymus-vulgaris-l-thymus-zygis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"48874","name":"EU/3/20/2288: Public summary of opinion on orphan designation for Magrolimab for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-22T10:33:00Z","last_updated_date":"2020-09-22T10:33:00Z","reference_number":"EMADOC-628903358-2476","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202288-public-summary-opinion-orphan-designation-magrolimab-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"48875","name":"EU/3/20/2289: Public summary of opinion on orphan designation for Nomacopan for the treatment of bullous pemphigoid","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-22T10:56:00Z","last_updated_date":"2020-09-22T10:56:00Z","reference_number":"EMADOC-628903358-2477","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202289-public-summary-opinion-orphan-designation-nomacopan-treatment-bullous-pemphigoid_en.pdf"},
    {"id":"48876","name":"EU/3/20/2290: Public summary of opinion on orphan designation for Stiripentol for the treatment of primary hyperoxaluria","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-22T11:03:00Z","last_updated_date":"2020-09-22T11:03:00Z","reference_number":"EMADOC-628903358-2478","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202290-public-summary-opinion-orphan-designation-stiripentol-treatment-primary-hyperoxaluria_en.pdf"},
    {"id":"48877","name":"EU/3/20/2291: Public summary of opinion on orphan designation for Onfekafusp alfa for the treatment of glioma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-22T11:31:00Z","last_updated_date":"2020-09-22T11:31:00Z","reference_number":"EMADOC-628903358-2479","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202291-public-summary-opinion-orphan-designation-onfekafusp-alfa-treatment-glioma_en.pdf"},
    {"id":"48879","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-09-22T15:58:00Z","last_updated_date":"2020-09-22T15:58:00Z","reference_number":"EMA/CAT/493027/2010","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-september-2020_en.pdf"},
    {"id":"48881","name":"Direct healthcare professional communication (DHPC): Nulojix (belatacept): Extension of the temporary restriction in supply up until 4Q 2021 (initiated in March 2017)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-09-23T12:27:00Z","last_updated_date":"2020-09-23T12:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-nulojix-belatacept-extension-temporary-restriction-supply-until-4q-2021-initiated-march-2017_en.pdf"},
    {"id":"48882","name":"EU/3/20/2292: Public summary of opinion on orphan designation for Anti-CD123 IgG1 humanised monoclonal antibody conjugated to N1-(2-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)ethyl)-N6-((S)-1-(((S)-1-((3-((((S)-8-methoxy-6-oxo-11,12,12a,13-tetrahydro-6H-benzo[","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-23T15:43:00Z","last_updated_date":"2020-09-23T15:43:00Z","reference_number":"EMADOC-628903358-2480","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202292-public-summary-opinion-orphan-designation-anti-cd123-igg1-humanised-monoclonal-antibody-conjugated-n1-2-25-dioxo-25-dihydro-1h-pyrrol-1-ylethyl-n6-s-1-s-1-3-s-8-methoxy-6-oxo-111212a13_en.pdf"},
    {"id":"48883","name":"EU/3/20/2293: Public summary of opinion on orphan designation for (+)-Epicatechin for the treatment of Becker muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-23T15:54:00Z","last_updated_date":"2020-09-23T15:54:00Z","reference_number":"EMADOC-628903358-2482","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202293-public-summary-opinion-orphan-designation-epicatechin-treatment-becker-muscular-dystrophy_en.pdf"},
    {"id":"48884","name":"EU/3/20/2294: Public summary of opinion on orphan designation for Sodium cromoglicate for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-23T16:02:00Z","last_updated_date":"2020-09-23T16:02:00Z","reference_number":"EMADOC-628903358-2481","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202294-public-summary-opinion-orphan-designation-sodium-cromoglicate-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"48886","name":"Submission of comments on ‘Guideline on registry-based studies’ (EMA/484811/2020)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2020-09-24T12:00:00Z","last_updated_date":"2020-09-24T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-guideline-registry-based-studies-ema4848112020_en.doc"},
    {"id":"48887","name":"EU/3/20/2295: Public summary of opinion on orphan designation for Lys40(NODAGA-68Ga)NH2-exendin-4 for the diagnosis of insulinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-24T12:31:00Z","last_updated_date":"2020-09-24T12:31:00Z","reference_number":"EMADOC-628903358-2483","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202295-public-summary-opinion-orphan-designation-lys40nodaga-68ganh2-exendin-4-diagnosis-insulinoma_en.pdf"},
    {"id":"48888","name":"EU/3/20/2296: Public summary of opinion on orphan designation for Axicabtagene ciloleucel for the treatment of marginal zone lymphoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-24T14:40:00Z","last_updated_date":"2020-09-24T14:40:00Z","reference_number":"EMADOC-628903358-2484","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202296-public-summary-opinion-orphan-designation-axicabtagene-ciloleucel-treatment-marginal-zone-lymphoma_en.pdf"},
    {"id":"48901","name":"Withdrawal assessment report for Sondelbay","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-09-28T15:49:00Z","last_updated_date":"2020-09-28T15:49:00Z","reference_number":"EMA/379279/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-sondelbay_en.pdf"},
    {"id":"48903","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-09-29T09:18:00Z","last_updated_date":"2020-09-29T09:18:00Z","reference_number":"EMA/402999/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-july-2020_en.pdf"},
    {"id":"48906","name":"Agenda - PRAC draft agenda of meeting 28 September - 1 October 2020","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-09-29T09:33:00Z","last_updated_date":"2020-09-29T09:33:00Z","reference_number":"EMA/PRAC/512067/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-28-september-1-october-2020_en.pdf"},
    {"id":"48917","name":"Yondelis Article-20 procedure - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2020-09-30T12:00:00Z","last_updated_date":"2020-09-30T12:00:00Z","reference_number":"EMA/470721/2020 ","document_url":"https://www.ema.europa.eu/en/documents/referral/yondelis-article-20-procedure-assessment-report_en.pdf"},
    {"id":"48919","name":"Agenda - Workshop on support for orphan medicines development","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-09-30T14:25:00Z","last_updated_date":"2020-10-12T17:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-support-orphan-medicines-development_en.pdf"},
    {"id":"48923","name":"Agenda of the 109th meeting of the Management Board: 1 October 2020","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2020-09-30T17:03:00Z","last_updated_date":"2020-10-05T13:00:00Z","reference_number":"EMA/MB/388242/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-109th-meeting-management-board-1-october-2020_en.pdf"},
    {"id":"48936","name":"Clobazam: List of nationally authorised medicinal products - PSUSA/00000798/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-10-02T12:14:00Z","last_updated_date":"2020-10-02T12:14:00Z","reference_number":"EMA/521021/2020 ","document_url":"https://www.ema.europa.eu/en/documents/psusa/clobazam-list-nationally-authorised-medicinal-products-psusa00000798202002_en.pdf"},
    {"id":"48937","name":"Labetalol: List of nationally authorised medicinal products - PSUSA/00001814/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-10-02T12:15:00Z","last_updated_date":"2020-10-02T12:15:00Z","reference_number":"EMA/494419/2020 ","document_url":"https://www.ema.europa.eu/en/documents/psusa/labetalol-list-nationally-authorised-medicinal-products-psusa00001814202002_en.pdf"},
    {"id":"48938","name":"Acetyl salicylic acid / atorvastatin / ramipril: List of nationally authorised medicinal products - PSUSA/00010280/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-10-02T12:18:00Z","last_updated_date":"2020-10-02T12:18:00Z","reference_number":"EMA/494405/2020 ","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetyl-salicylic-acid-atorvastatin-ramipril-list-nationally-authorised-medicinal-products-psusa00010280202002_en.pdf"},
    {"id":"48939","name":"Direct healthcare professional communication (DHPC): Leuprorelin-containing depot products: need to strictly follow instructions for reconstitution and administration to reduce the risk of handling errors that may result in lack of efficacy","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-10-02T15:04:00Z","last_updated_date":"2020-10-02T15:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-leuprorelin-containing-depot-products-need-strictly-follow-instructions-reconstitution-and-administration-reduce-risk-handling-errors-may-result-lack_en.pdf"},
    {"id":"48940","name":"PRAC statistics: October 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-02T15:31:00Z","last_updated_date":"2020-10-02T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-october-2020_en.pdf"},
    {"id":"48941","name":"Reply to the European Ombudsman’s letter concerning transparency and independence of the work of the European Medicines Agency in supporting the development and evaluation of COVID-19 medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-10-05T12:00:00Z","last_updated_date":"2020-10-05T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/reply-european-ombudsmans-letter-concerning-transparency-and-independence-work-european-medicines-agency-supporting-development-and-evaluation-covid-19-medicines_en.pdf"},
    {"id":"48942","name":"European Medicines Agency mid-year report 2020 (January-June 2020)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-05T13:00:00Z","last_updated_date":"2020-10-05T13:00:00Z","reference_number":"EMA/386447/2020","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-mid-year-report-2020-january-june-2020_en.pdf"},
    {"id":"48944","name":"Summary of transfers of appropriations in budget 2020 - Issues for consideration - Management Board meeting of 1 October 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-05T13:00:00Z","last_updated_date":"2020-10-05T13:00:00Z","reference_number":"EMA/MB/447191/2020","document_url":"https://www.ema.europa.eu/en/documents/report/summary-transfers-appropriations-budget-2020-issues-consideration-management-board-meeting-1-october-2020_en.pdf"},
    {"id":"48949","name":"Agenda - 25 Years of EMA: building, learning and adapting to new challenges","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-10-05T17:51:00Z","last_updated_date":"2020-10-21T11:38:00Z","reference_number":"EMA/449946/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-25-years-ema-building-learning-and-adapting-new-challenges_en.pdf"},
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    {"id":"48951","name":"Dinolytic and generics Article-35 referral - Questions and answers on the review of withdrawal periods for Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products 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    {"id":"48955","name":"Agenda - Training session for patients, consumers and healthcare professionals interested in EMA activities","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-10-06T14:39:00Z","last_updated_date":"2020-10-06T14:39:00Z","reference_number":"EMA/134548/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-training-session-patients-consumers-and-healthcare-professionals-interested-ema-activities_en.pdf"},
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    {"id":"48984","name":"Public statement on Qtrilmet: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-10-09T15:31:00Z","last_updated_date":"2020-10-09T15:31:00Z","reference_number":"EMA/486077/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-qtrilmet-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"48990","name":"Haemophilus type b and meningococcal group c conjugate vaccine: List of nationally authorised medicinal products - PSUSA/00001583/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-10-12T10:09:00Z","last_updated_date":"2020-10-12T10:09:00Z","reference_number":"EMA/537226/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/haemophilus-type-b-and-meningococcal-group-c-conjugate-vaccine-list-nationally-authorised-medicinal-products-psusa00001583202002_en.pdf"},
    {"id":"48992","name":"Agenda - CAT agenda of the 7-9 October 2020 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-10-12T11:16:00Z","last_updated_date":"2020-10-12T11:16:00Z","reference_number":"EMA/CAT/531222/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-7-9-october-2020-meeting_en.pdf"},
    {"id":"48993","name":"Sevoflurane: List of nationally authorised medicinal products - PSUSA/00002698/202001","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2020-10-12T12:18:00Z","last_updated_date":"2020-10-12T12:18:00Z","reference_number":"EMA/PRAC/535637/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/sevoflurane-list-nationally-authorised-medicinal-products-psusa00002698202001_en.pdf"},
    {"id":"48994","name":"Mannitol (all indications apart from cystic fibrosis): List of nationally authorised medicinal products - PSUSA/00010005/202002","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2020-10-12T12:23:00Z","last_updated_date":"2020-10-12T12:23:00Z","reference_number":"EMA/PRAC/535721/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/mannitol-all-indications-apart-cystic-fibrosis-list-nationally-authorised-medicinal-products-psusa00010005202002_en.pdf"},
    {"id":"48996","name":"Human medicines highlights - October 2020","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2020-10-12T14:52:00Z","last_updated_date":"2020-10-12T14:52:00Z","reference_number":"Issue 139","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-october-2020_en.pdf"},
    {"id":"49003","name":"Public statement on Zerit: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-10-13T14:55:00Z","last_updated_date":"2020-10-13T14:55:00Z","reference_number":"EMA/446125/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zerit-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"49007","name":"Rupturewort: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2020-10-14T15:09:00Z","last_updated_date":"2020-10-14T15:09:00Z","reference_number":"EMA/382941/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/rupturewort-summary-public_en.pdf"},
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    {"id":"49040","name":"Overview of comments received on  ICH guideline M7 on  assessment and control of DNA reactive (mutagenic)  impurities in pharmaceuticals to limit potential  carcinogenic risk  - questions & answers  (EMA/CHMP/ICH/321999/2020)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2020-10-16T11:59:00Z","last_updated_date":"2020-10-16T11:59:00Z","reference_number":"EMA/538158/2020","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-guideline-m7-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-questions-answers-emachmpich3219992020_en.pdf"},
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    {"id":"49047","name":"Production API and registration process","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T10:20:00Z","last_updated_date":"2020-10-21T10:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/production-api-and-registration-process_en.pdf"},
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    {"id":"49049","name":"Presentation - PMS, UPD and FHIR","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T10:10:00Z","last_updated_date":"2020-10-21T10:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pms-upd-and-fhir_en.pdf"},
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    {"id":"49051","name":"Influenza vaccine (split virion, inactivated, prepared in cell cultures) : List of nationally authorised medicinal products - PSUSA/00010299/202003","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-10-19T14:56:00Z","last_updated_date":"2020-10-19T14:56:00Z","reference_number":"EMA/536363/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-prepared-cell-cultures-list-nationally-authorised-medicinal-products-psusa00010299202003_en.pdf"},
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    {"id":"49054","name":"Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202003","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-10-19T15:00:00Z","last_updated_date":"2020-10-19T15:00:00Z","reference_number":"EMA/535987/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa00001744202003_en.pdf"},
    {"id":"49056","name":"UPD Production Release Notes","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T10:20:00Z","last_updated_date":"2020-10-21T10:20:00Z","reference_number":"EMA/556635/2020","document_url":"https://www.ema.europa.eu/en/documents/other/upd-production-release-notes_en.pdf"},
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    {"id":"49061","name":"Feverfew herb: Summary for the public","type":"herbal-summary","status":"unknown","consultation_date":"","first_published_date":"2020-10-20T15:09:00Z","last_updated_date":"2020-10-20T15:09:00Z","reference_number":"EMA/380074/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/feverfew-herb-summary-public_en.pdf"},
    {"id":"49062","name":"Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Timetable for the procedure - CHMP Opinion on the impact of the Article 5(3) referral on nitrosamines in human medicinal products on the referral","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-10-20T11:54:00Z","last_updated_date":"2020-10-20T11:54:00Z","reference_number":"EMA/CHMP/525148/2020","document_url":"https://www.ema.europa.eu/en/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-timetable-procedure-chmp-opinion-impact-article-53-referral-nitrosamines-human-medicinal-products-referral_en.pdf"},
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    {"id":"49064","name":"Withdrawal assessment report for Rayoqta","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-10-21T11:55:00Z","last_updated_date":"2020-10-21T11:55:00Z","reference_number":"EMA/CHMP/279665/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-rayoqta_en.pdf"},
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    {"id":"49067","name":"Austria - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/austria-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49068","name":"Belgium - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/belgium-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49069","name":"Bulgaria - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/bulgaria-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49070","name":"Croatia - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/croatia-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49071","name":"Cyprus - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/cyprus-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49072","name":"Czechia- trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/czechia-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49073","name":"Denmark - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/denmark-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49074","name":"Estonia - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/estonia-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49075","name":"Finland - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/finland-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49076","name":"France - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/france-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49077","name":"Germany - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/germany-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49078","name":"Greece - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/greece-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49079","name":"Hungary - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/hungary-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49080","name":"Iceland - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/iceland-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49081","name":"Ireland - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/ireland-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49082","name":"Italy - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/italy-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49083","name":"Latvia - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/latvia-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49084","name":"Lithuania - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/lithuania-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49085","name":"Luxembourg - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/luxembourg-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49086","name":"Malta - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/malta-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49087","name":"Netherlands - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/netherlands-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49088","name":"Norway - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/norway-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49089","name":"Poland - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/poland-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49090","name":"Portugal - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/portugal-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49091","name":"Romania - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/romania-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49092","name":"Slovakia - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/slovakia-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49093","name":"Slovenia - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/slovenia-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49094","name":"Spain - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/spain-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49095","name":"Sweden - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/sweden-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49096","name":"Switzerland - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/switzerland-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49097","name":"United Kingdom - trends in the sales of veterinary antibiotics between 2010 and 2018","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-21T16:00:00Z","last_updated_date":"2020-10-21T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/united-kingdom-trends-sales-veterinary-antibiotics-between-2010-and-2018_en.pdf"},
    {"id":"49102","name":"Panexcell Article-31 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-10-22T09:40:00Z","last_updated_date":"2020-10-22T09:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/panexcell-article-31-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/panexcell-article-31-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/panexcell-article-31-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/panexcell-article-31-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/panexcell-article-31-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/panexcell-article-31-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/panexcell-article-31-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/panexcell-article-31-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/panexcell-article-31-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/panexcell-article-31-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/panexcell-article-31-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/panexcell-article-31-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/panexcell-article-31-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/panexcell-article-31-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/panexcell-article-31-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/panexcell-article-31-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/panexcell-article-31-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/panexcell-article-31-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/panexcell-article-31-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/panexcell-article-31-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/panexcell-article-31-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/panexcell-article-31-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/panexcell-article-31-referral-annex-ii_sv.pdf"}},
    {"id":"49103","name":"Panexcell Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-10-22T09:43:00Z","last_updated_date":"2020-10-22T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/panexcell-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/panexcell-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/panexcell-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/panexcell-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/panexcell-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/panexcell-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/panexcell-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/panexcell-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/panexcell-article-31-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/panexcell-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/panexcell-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/panexcell-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/panexcell-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/panexcell-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/panexcell-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/panexcell-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/panexcell-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/panexcell-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/panexcell-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/panexcell-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/panexcell-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/panexcell-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/panexcell-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"49104","name":"Withdrawal assessment report for Abilify MyCite","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-10-22T11:55:00Z","last_updated_date":"2020-10-22T11:55:00Z","reference_number":"EMA/CHMP/431264/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-abilify-mycite_en.pdf"},
    {"id":"49107","name":"Reflection paper on the pharmaceutical development of medicines for use in the older population - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-10-22T14:35:00Z","last_updated_date":"2020-10-22T14:35:00Z","reference_number":"EMA/CHMP/QWP/292439/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-pharmaceutical-development-medicines-use-older-population-first-version_en.pdf"},
    {"id":"49109","name":"Presentation - 1.3 Overview of core recommendations of the draft guideline and comments received (Xavier Kurz, Valerie Strassmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:17:00Z","last_updated_date":"2020-10-23T08:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-13-overview-core-recommendations-draft-guideline-and-comments-received-xavier-kurz-valerie-strassmann_en.pdf"},
    {"id":"49110","name":"Presentation - 2.6 Industry perspective on registry (Chris Chinn)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:21:00Z","last_updated_date":"2020-10-23T08:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-26-industry-perspective-registry-chris-chinn_en.pdf"},
    {"id":"49111","name":"Presentation - 2.6 Registry holders perspective (Eoin McGrath)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:22:00Z","last_updated_date":"2020-10-23T08:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-26-registry-holders-perspective-eoin-mcgrath_en.pdf"},
    {"id":"49112","name":"Presentation - 2.6 Patients association perspective (Mariette Driessens)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:24:00Z","last_updated_date":"2020-10-23T08:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-26-patients-association-perspective-mariette-driessens_en.pdf"},
    {"id":"49113","name":"Presentation - 2.6 Regulators example MS registry (VMarion Haberkamp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:26:00Z","last_updated_date":"2020-10-23T08:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-26-regulators-example-ms-registry-vmarion-haberkamp_en.pdf"},
    {"id":"49114","name":"Presentation - 2.6 Stakeholder perspective regulator (Milena Stain)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:28:00Z","last_updated_date":"2020-10-23T08:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-26-stakeholder-perspective-regulator-milena-stain_en.pdf"},
    {"id":"49115","name":"Presentation - 3.10 Survey on the collection of data on adverse events related to medicinal products through registries (Kelly Plueschke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:29:00Z","last_updated_date":"2020-10-23T08:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-310-survey-collection-data-adverse-events-related-medicinal-products-through-registries-kelly-plueschke_en.pdf"},
    {"id":"49116","name":"Presentation - 3.8 Experience of randomisation within a registry (Barbara Casadei)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:30:00Z","last_updated_date":"2020-10-23T08:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-38-experience-randomisation-within-registry-barbara-casadei_en.pdf"},
    {"id":"49117","name":"Presentation - 3.9 Data quality and data verification in registries - results of a stakeholders survey (Carla Jonker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T08:32:00Z","last_updated_date":"2020-10-23T08:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-39-data-quality-and-data-verification-registries-results-stakeholders-survey-carla-jonker_en.pdf"},
    {"id":"49119","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T15:10:00Z","last_updated_date":"2020-10-23T15:10:00Z","reference_number":"EMA/CAT/547273/2010","document_url":"https://www.ema.europa.eu/en/documents/report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-october-2020_en.pdf"},
    {"id":"49120","name":"CHMP ORGAM agenda for the meeting on 5 October 2020","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2020-10-23T15:27:00Z","last_updated_date":"2020-10-23T15:27:00Z","reference_number":"EMA/534390/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-orgam-agenda-meeting-5-october-2020_en.pdf"},
    {"id":"49121","name":"Agenda - European networkof paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T15:58:00Z","last_updated_date":"2020-10-23T15:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-networkof-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting_en.pdf"},
    {"id":"49122","name":"Minutes of the European networkof paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2020-10-23T16:00:00Z","last_updated_date":"2020-10-23T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-networkof-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting_en.pdf"},
    {"id":"49129","name":"Decision on Amending Budget No 1-2020","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2020-10-26T16:04:00Z","last_updated_date":"2020-10-26T16:04:00Z","reference_number":"EMA/MB/460018/2020","document_url":"https://www.ema.europa.eu/en/documents/other/decision-amending-budget-no-1-2020_en.pdf"},
    {"id":"49130","name":"Agenda - PRAC draft agenda of meeting 26-29 October 2020","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-10-26T16:13:00Z","last_updated_date":"2020-10-26T16:13:00Z","reference_number":"EMA/PRAC/570668/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-26-29-october-2020_en.pdf"},
    {"id":"49141","name":"Lessons learnt from presence of N-nitrosamine impurities in sartan medicines - Implementation plan","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-10-28T13:20:00Z","last_updated_date":"2020-10-28T13:20:00Z","reference_number":"EMA/503522/2020","document_url":"https://www.ema.europa.eu/en/documents/other/lessons-learnt-presence-n-nitrosamine-impurities-sartan-medicines-implementation-plan_en.pdf"},
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    {"id":"49148","name":"Cabazitaxel Accord : Letter to healthcare professionals about risk of mix-ups with Jevtana (cabazitaxel)","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2020-10-28T15:19:00Z","last_updated_date":"2020-10-28T15:19:00Z","reference_number":"EMA/243153/2020","document_url":"https://www.ema.europa.eu/en/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_da.pdf","de":"https://www.ema.europa.eu/de/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_de.pdf","et":"https://www.ema.europa.eu/et/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_et.pdf","el":"https://www.ema.europa.eu/el/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medication-error/cabazitaxel-accord-letter-healthcare-professionals-about-risk-mix-ups-jevtana-cabazitaxel_sv.pdf"}},
    {"id":"49149","name":"Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-10-28T15:22:00Z","last_updated_date":"2020-10-28T15:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-cabazitaxel-accord-20-mgml-concentrate-solution-infusion-risk-medication-errors-and-mix-jevtana-60-mg15-ml-concentrate-and-solvent-solution-infusion_en.pdf"},
    {"id":"49150","name":"Withdrawal assessment report for Upkanz","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2020-10-28T11:55:00Z","last_updated_date":"2020-10-28T11:55:00Z","reference_number":"EMA/CHMP/532991/2020","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-upkanz_en.pdf"},
    {"id":"49152","name":"Public statement on Vepacel: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-10-28T17:14:00Z","last_updated_date":"2020-10-28T17:14:00Z","reference_number":"EMA/542469/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-vepacel-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"49153","name":"Direct healthcare professional communication (DHPC): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-10-29T15:22:00Z","last_updated_date":"2020-10-29T15:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-systemic-and-inhaled-fluoroquinolones-risk-heart-valve-regurgitationincompetence_en.pdf"},
    {"id":"49155","name":"Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-10-29T11:15:00Z","last_updated_date":"2020-10-29T11:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-esbriet-pirfenidone-important-safety-update-and-new-recommendations-prevent-drug-induced-liver-injury-dili_en.pdf"},
    {"id":"49160","name":"Questions and answers on the review of withdrawal periods for Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products 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    {"id":"49162","name":"PRAC statistics: October-November 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-10-30T12:00:00Z","last_updated_date":"2020-10-30T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-october-november-2020_en.pdf"},
    {"id":"49163","name":"Reply to open letter concerning the transparency and evaluation of vaccines for COVID-19","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-10-30T14:00:00Z","last_updated_date":"2020-10-30T14:00:00Z","reference_number":"EMA/565800/2020","document_url":"https://www.ema.europa.eu/en/documents/other/reply-open-letter-concerning-transparency-and-evaluation-vaccines-covid-19_en.pdf"},
    {"id":"49164","name":"Veterinary Medicines Regulation highlights - Issue 2","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2020-10-30T15:35:00Z","last_updated_date":"2020-10-30T15:35:00Z","reference_number":"Issue 2","document_url":"https://www.ema.europa.eu/en/documents/newsletter/veterinary-medicines-regulation-highlights-issue-2_en.pdf"},
    {"id":"49170","name":"Form: Notification of change for paediatric procedures","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2020-11-03T17:33:00Z","last_updated_date":"2020-11-03T17:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/form-notification-change-paediatric-procedures_en.pdf"},
    {"id":"49172","name":"Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-11-04T09:04:00Z","last_updated_date":"2020-11-04T09:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-ondexxya-andexanet-alfa-avoid-use-andexanet-prior-heparinization_en.pdf"},
    {"id":"49173","name":"Declaration of interests: Karl Hamilton","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-11-04T12:00:00Z","last_updated_date":"2022-06-30T16:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-karl-hamilton_en.pdf"},
    {"id":"49179","name":"Agenda - CAT agenda of the 4-6 November 2020 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-11-04T17:18:00Z","last_updated_date":"2020-11-04T17:18:00Z","reference_number":"EMA/CAT/588925/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-4-6-november-2020-meeting_en.pdf"},
    {"id":"49180","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: August-September 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-11-04T17:25:00Z","last_updated_date":"2020-11-04T17:25:00Z","reference_number":"EMA/477659/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-august-september-2020_en.pdf"},
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    {"id":"49241","name":"Withdrawal letter: Tibsovo","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2020-11-13T15:02:00Z","last_updated_date":"2020-11-13T15:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-tibsovo_en.pdf"},
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    {"id":"49244","name":"Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Nitrosamines: EMA aligns recommendations for sartans with those for other medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-11-13T17:29:00Z","last_updated_date":"2020-11-13T17:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-nitrosamines-ema-aligns-recommendations-sartans-those-other-medicines_en.pdf"},
    {"id":"49245","name":"CHMP post-authorisation summary of positive opinion for Trimbow (X-08-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-11-13T18:02:00Z","last_updated_date":"2020-11-13T18:02:00Z","reference_number":"EMA/599401/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trimbow-x-08-g_en.pdf"},
    {"id":"49247","name":"Ulipristal acetate 5mg medicinal products Article-31 referral - Ulipristal acetate for uterine fibroids: EMA recommends restricting use","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2020-11-13T08:37:00Z","last_updated_date":"2021-01-14T11:00:00Z","reference_number":"EMA/24778/2021","document_url":"https://www.ema.europa.eu/en/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-ulipristal-acetate-uterine-fibroids-ema-recommends-restricting-use_sv.pdf"}},
    {"id":"49249","name":"Ulipristal acetate 5mg medicinal products Article-31 referral - Amendments to the relevant sections of the product information (Annex III)","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2020-11-13T12:00:00Z","last_updated_date":"2020-11-17T10:00:00Z","reference_number":"Corr.1","document_url":"https://www.ema.europa.eu/en/documents/referral/ulipristal-acetate-5mg-medicinal-products-article-31-referral-amendments-relevant-sections-product-information-annex-iii_en.pdf"},
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    {"id":"49251","name":"CHMP post-authorisation summary of positive opinion for Tivicay (X-58-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2020-11-13T13:00:00Z","last_updated_date":"2020-11-13T13:00:00Z","reference_number":"EMA/CHMP/540606/2020","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tivicay-x-58-g_en.pdf"},
    {"id":"49252","name":"Pharmacovigilance plan of the EU Regulatory Network for COVID-19 vaccines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-11-13T14:30:00Z","last_updated_date":"2020-11-13T14:30:00Z","reference_number":"EMA/333964/2020","document_url":"https://www.ema.europa.eu/en/documents/other/pharmacovigilance-plan-eu-regulatory-network-covid-19-vaccines_en.pdf"},
    {"id":"49254","name":"Letter from the chairs of EMA's Management Board to Guido Rasi at the end of his term as EMA's Executive Director","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-11-13T14:49:00Z","last_updated_date":"2020-11-13T14:49:00Z","reference_number":"EMA/561503/2020","document_url":"https://www.ema.europa.eu/en/documents/other/letter-chairs-emas-management-board-guido-rasi-end-his-term-emas-executive-director_en.pdf"},
    {"id":"49262","name":"Agenda - EMA public stakeholder meeting on COVID-19","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-12-10T11:00:00Z","last_updated_date":"2020-12-10T14:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-public-stakeholder-meeting-covid-19_en.pdf"},
    {"id":"49263","name":"Agenda - 15th industry stakeholder platform - Operation of European Union (EU) pharmacovigilance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-11-17T17:26:00Z","last_updated_date":"2020-11-17T17:26:00Z","reference_number":"EMA/342512/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-15th-industry-stakeholder-platform-operation-european-union-eu-pharmacovigilance_en.pdf"},
    {"id":"49264","name":"Presentation - Update of EudraVigilance operational plan (milestones 2020-2022) (Rodrigo Postigo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-11-17T17:30:00Z","last_updated_date":"2020-11-17T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-eudravigilance-operational-plan-milestones-2020-2022-rodrigo-postigo_en.pdf"},
    {"id":"49265","name":"Presentation - Good pharmacovigilance practices (GVP) - GVP PIII update after public consultation (Corinne de Vries)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-11-17T17:34:00Z","last_updated_date":"2020-11-17T17:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-gvp-gvp-piii-update-after-public-consultation-corinne-de-vries_en.pdf"},
    {"id":"49266","name":"Presentation - Good pharmacovigilance practices (GVP) - GVPs updates including GVP XVI and PASS addendum (Priya Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-11-17T17:37:00Z","last_updated_date":"2020-11-17T17:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-good-pharmacovigilance-practices-gvp-gvps-updates-including-gvp-xvi-and-pass-addendum-priya-bahri_en.pdf"},
    {"id":"49267","name":"Presentation - Monitoring of COVID-19 products (vaccines and therapeutics) (Georgy Genov)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-11-17T17:39:00Z","last_updated_date":"2020-11-17T17:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-covid-19-products-vaccines-and-therapeutics-georgy-genov_en.pdf"},
    {"id":"49268","name":"Presentation - Preparations for the end of transition period for UK’s withdrawal from the EU (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-11-17T18:02:00Z","last_updated_date":"2020-11-17T18:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preparations-end-transition-period-uks-withdrawal-eu-marie-helene-pinheiro_en.pdf"},
    {"id":"49272","name":"Meeting highlights - 15th industry stakeholder platform - Operation of European Union (EU) pharmacovigilance","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2020-11-18T15:40:00Z","last_updated_date":"2020-11-18T15:40:00Z","reference_number":"EMA/582239/2020","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-highlights-15th-industry-stakeholder-platform-operation-european-union-eu-pharmacovigilance_en.pdf"},
    {"id":"49279","name":"EMA considerations on COVID-19 vaccine approval","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T12:00:00Z","last_updated_date":"2020-11-19T12:00:00Z","reference_number":"EMA/592928/2020","document_url":"https://www.ema.europa.eu/en/documents/other/ema-considerations-covid-19-vaccine-approval_en.pdf"},
    {"id":"49280","name":"EU/3/20/2299: Public summary of opinion on orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for the treatment of achondroplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2617","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202299-public-summary-opinion-orphan-designation-c-type-natriuretic-peptide-conjugated-multi-arm-polyethylene-glycol-carrier-through-cleavable-linker-treatment-achondroplasia_en.pdf"},
    {"id":"49281","name":"EU/3/20/2300: Public summary of opinion on orphan designation: Fasudil hydrochloride for the treatment of non-traumatic subarachnoid haemorrhage","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2616","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202300-public-summary-opinion-orphan-designation-fasudil-hydrochloride-treatment-non-traumatic-subarachnoid-haemorrhage_en.pdf"},
    {"id":"49282","name":"EU/3/20/2301: Public summary of opinion on orphan designation: Pegylated adrenomedullin for the treatment of acute respiratory distress syndrome","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2618","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202301-public-summary-opinion-orphan-designation-pegylated-adrenomedullin-treatment-acute-respiratory-distress-syndrome_en.pdf"},
    {"id":"49284","name":"EU/3/20/2302: Public summary of opinion on orphan designation: Triheptanoin for the treatment of carnitine-acylcarnitine translocase deficiency","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2624","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202302-public-summary-opinion-orphan-designation-triheptanoin-treatment-carnitine-acylcarnitine-translocase-deficiency_en.pdf"},
    {"id":"49285","name":"EU/3/20/2303: Public summary of opinion on orphan designation: Adeno-associated viral vector expressing acid alpha-glucosidase gene for the treatment of glycogen storage disease type II (Pompe's disease)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2619","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202303-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-expressing-acid-alpha-glucosidase-gene-treatment-glycogen-storage-disease-type-ii-pompes-disease_en.pdf"},
    {"id":"49286","name":"EU/3/20/2304: Public summary of opinion on orphan designation: Maralixibat chloride for the treatment of biliary atresia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2620","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202304-public-summary-opinion-orphan-designation-maralixibat-chloride-treatment-biliary-atresia_en.pdf"},
    {"id":"49287","name":"EU/3/20/2305: Public summary of opinion on orphan designation: Imetelstat sodium for the treatment of myelodysplastic syndromes","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2621","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202305-public-summary-opinion-orphan-designation-imetelstat-sodium-treatment-myelodysplastic-syndromes_en.pdf"},
    {"id":"49288","name":"EU/3/20/2306: Public summary of opinion on orphan designation: Retinol palmitate for the prevention of bronchopulmonary dysplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2622","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202306-public-summary-opinion-orphan-designation-retinol-palmitate-prevention-bronchopulmonary-dysplasia_en.pdf"},
    {"id":"49289","name":"EU/3/20/2307: Public summary of opinion on orphan designation: Tinostamustine for the treatment of T-cell prolymphocytic leukaemia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2623","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202307-public-summary-opinion-orphan-designation-tinostamustine-treatment-t-cell-prolymphocytic-leukaemia_en.pdf"},
    {"id":"49290","name":"Public summary of opinion on orphan designation: Melatonin for the treatment of intracerebral haemorrhage","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2614","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-melatonin-treatment-intracerebral-haemorrhage_en.pdf"},
    {"id":"49291","name":"Public summary of opinion on orphan designation: Benzyl benzoate, beta-caryophyllene, cineole, cinnamaldehyde, cinnamyl acetate, linalool, trans-2-methoxycinnamaldehyde for the treatment of eumycetoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-19T01:00:00Z","last_updated_date":"2020-11-19T01:00:00Z","reference_number":"EMADOC-628903358-2613","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/public-summary-opinion-orphan-designation-benzyl-benzoate-beta-caryophyllene-cineole-cinnamaldehyde-cinnamyl-acetate-linalool-trans-2-methoxycinnamaldehyde-treatment-eumycetoma_en.pdf"},
    {"id":"49295","name":"Letter of support for N170 ERP as a prognostic biomarker for adaptive social functioning and its potential to stratify study populations in people with Autism spectrum disorders (ASD) without intellectual disability","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-11-20T09:25:00Z","last_updated_date":"2020-11-20T09:25:00Z","reference_number":"EMA/508140/2020","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-n170-erp-prognostic-biomarker-adaptive-social-functioning-and-its-potential-stratify-study-populations-people-autism-spectrum-disorders-asd-without-intellectual-disability_en.pdf"},
    {"id":"49296","name":"Letter of support for the VABS-II Adaptive Behavior Composite (VABS-II-ABC) score as measure of adaptive social functioning in people with Autism Spectrum Disorders (ASD) without intellectual disability","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-11-20T09:28:00Z","last_updated_date":"2020-11-20T09:28:00Z","reference_number":"EMA/548136/2020","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-vabs-ii-adaptive-behavior-composite-vabs-ii-abc-score-measure-adaptive-social-functioning-people-autism-spectrum-disorders-asd-without-intellectual-disability_en.pdf"},
    {"id":"49300","name":"EU/3/20/2308: Public summary of opinion on orphan designation: Allogeneic umbilical cord tissue-derived mesenchymal stromal cells ex vivo expanded for the prevention of bronchopulmonary dysplasia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-24T01:00:00Z","last_updated_date":"2020-11-24T01:00:00Z","reference_number":"EMADOC-628903358-2736","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202308-public-summary-opinion-orphan-designation-allogeneic-umbilical-cord-tissue-derived-mesenchymal-stromal-cells-ex-vivo-expanded-prevention-bronchopulmonary-dysplasia_en.pdf"},
    {"id":"49301","name":"EU/3/20/2309: Public summary of opinion on orphan designation: Bis-(3-deoxy-3-(4-(3-fluorophenyl)-1H-1,2,3-triazol-1-yl)-beta-D-galactopyranosyl) sulfane for the treatment of idiopathic pulmonary fibrosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2737","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202309-public-summary-opinion-orphan-designation-bis-3-deoxy-3-4-3-fluorophenyl-1h-123-triazol-1-yl-beta-d-galactopyranosyl-sulfane-treatment-idiopathic-pulmonary-fibrosis_en.pdf"},
    {"id":"49303","name":"EU/3/20/2310: Public summary of opinion on orphan designation: Adeno-associated virus serotype 2/8 vector containing the human PDE6A gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2738","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202310-public-summary-opinion-orphan-designation-adeno-associated-virus-serotype-28-vector-containing-human-pde6a-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"49304","name":"EU/3/20/2311: Public summary of opinion on orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2739","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202311-public-summary-opinion-orphan-designation-sodium-4-e-3-4-fluorophenyl-3-4-3-morpholin-4-yl-prop1ynylphenylallyloxy-2-methylphenoxyacetate_en.pdf"},
    {"id":"49305","name":"EU/3/20/2312: Public summary of opinion on orphan designation: Allogeneic hepatoblastoma cells encapsulated in alginate, ex vivo expanded for the treatment of acute liver failure","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2740","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202312-public-summary-opinion-orphan-designation-allogeneic-hepatoblastoma-cells-encapsulated-alginate-ex-vivo-expanded-treatment-acute-liver-failure_en.pdf"},
    {"id":"49306","name":"EU/3/20/2313: Public summary of opinion on orphan designation: 2-(2-(18F)fluoropyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine for the diagnosis of progressive supranuclear palsy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2756","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202313-public-summary-opinion-orphan-designation-2-2-18ffluoropyridin-4-yl-9h-pyrrolo23-b45-cdipyridine-diagnosis-progressive-supranuclear-palsy_en.pdf"},
    {"id":"49307","name":"EU/3/20/2314: Public summary of opinion on orphan designation: Humanised IgG1 monoclonal antibody against human eotaxin-2 for the treatment of primary sclerosing cholangitis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2741","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202314-public-summary-opinion-orphan-designation-humanised-igg1-monoclonal-antibody-against-human-eotaxin-2-treatment-primary-sclerosing-cholangitis_en.pdf"},
    {"id":"49308","name":"EU/3/20/2315: Public summary of opinion on orphan designation: Pentosan polysulfate sodium for the treatment of mucopolysaccharidosis type VI","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2742","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202315-public-summary-opinion-orphan-designation-pentosan-polysulfate-sodium-treatment-mucopolysaccharidosis-type-vi_en.pdf"},
    {"id":"49309","name":"EU/3/20/2316: Public summary of opinion on orphan designation: Protein-based delivery vector carrying a DNA payload encoding an RNA-guided nuclease that targets stx genes of Shiga toxin-producing Escherichia coli","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2743","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202316-public-summary-opinion-orphan-designation-protein-based-delivery-vector-carrying-dna-payload-encoding-rna-guided-nuclease-targets-stx-genes-shiga-toxin-producing-escherichia-coli_en.pdf"},
    {"id":"49312","name":"Public statement on Ribavirin Mylan: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2020-11-23T12:00:00Z","last_updated_date":"2020-11-23T12:00:00Z","reference_number":"EMA/533134/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-ribavirin-mylan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"49313","name":"Overview of comments received on 'Abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance' - Revision 1","type":"comments","status":"Adopted","consultation_date":"","first_published_date":"2020-11-23T13:29:00Z","last_updated_date":"2020-11-23T13:29:00Z","reference_number":"EMA/CHMP/567816/2020","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-abiraterone-tablets-250-mg-and-500-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"49314","name":"Abiraterone acetate tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-11-23T13:32:00Z","last_updated_date":"2020-11-23T13:32:00Z","reference_number":"EMA/CHMP/474712/2016 Rev. 1 Corr 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/abiraterone-acetate-tablets-250-mg-and-500-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"49316","name":"Agenda - PRAC draft agenda of meeting 23-26 November 2020","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2020-11-23T15:15:00Z","last_updated_date":"2020-11-23T15:15:00Z","reference_number":"EMA/PRAC/630501/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-23-26-november-2020_en.pdf"},
    {"id":"49318","name":"Overview of comments received on 'Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st draft)","type":"comments","status":"Adopted","consultation_date":"","first_published_date":"2020-11-23T15:46:00Z","last_updated_date":"2020-11-23T15:46:00Z","reference_number":"EMA/CHMP/567884/2020","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-lapatinib-film-coated-tablet-250-mg-product-specific-bioequivalence-guidance-first-version-1st-draft_en.pdf"},
    {"id":"49319","name":"Agenda - Multi-stakeholder webinar to support implementation of Article 117 of the MDR 2017/745 on drug-device combinations","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2020-11-23T16:00:00Z","last_updated_date":"2020-11-27T10:30:00Z","reference_number":"EMA/128303/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-multi-stakeholder-webinar-support-implementation-article-117-mdr-2017745-drug-device-combinations_en.pdf"},
    {"id":"49337","name":"EU/3/20/2317: Public summary of opinion on orphan designation: Allogeneic T-cell precursors, mobilised peripheral blood-derived, ex vivo cultured for treatment in haematopoietic stem cell transplantation","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2744","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202317-public-summary-opinion-orphan-designation-allogeneic-t-cell-precursors-mobilised-peripheral-blood-derived-ex-vivo-cultured-treatment-haematopoietic-stem-cell-transplantation_en.pdf"},
    {"id":"49338","name":"EU/3/20/2318: Public summary of opinion on orphan designation: Dextran sulfate low molecular weight for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2745","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202318-public-summary-opinion-orphan-designation-dextran-sulfate-low-molecular-weight-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"49339","name":"EU/3/20/2319: Public summary of opinion on orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2746","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202319-public-summary-opinion-orphan-designation-sodium-4-e-3-4-fluorophenyl-3-4-3-morpholin-4-yl-prop1ynylphenylallyloxy-2-methylphenoxyacetate_en.pdf"},
    {"id":"49340","name":"EU/3/20/2320: Public summary of opinion on orphan designation: Copper histidinate for the treatment of Menkes disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2748","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202320-public-summary-opinion-orphan-designation-copper-histidinate-treatment-menkes-disease_en.pdf"},
    {"id":"49341","name":"EU/3/20/2321: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 3B encoding shortened human ATP7B for the treatment of Wilson's disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2747","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202321-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-3b-encoding-shortened-human-atp7b-treatment-wilsons-disease_en.pdf"},
    {"id":"49342","name":"EU/3/20/2322: Public summary of opinion on orphan designation: 6-((3S,4S)-4-Methyl-1-(pyrimidin-2-yl-methyl)pyrrolidin-3-yl)-3-tetrahydropyran-4-yl-7H-imidazo(1,5-a)pyrazin-8-one for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2022-11-08T11:05:00Z","reference_number":"EMADOC-628903358-2749","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202322-public-summary-opinion-orphan-designation-6-3s4s-4-methyl-1-pyrimidin-2-yl-methylpyrrolidin-3-yl-3-tetrahydropyran-4-yl-7h-imidazo15-apyrazin-8-one-treatment-sickle-cell-disease_en.pdf"},
    {"id":"49343","name":"EU/3/20/2323: Public summary of opinion on orphan designation: Trehalose for the treatment of mucopolysaccharidosis type III","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2750","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202323-public-summary-opinion-orphan-designation-trehalose-treatment-mucopolysaccharidosis-type-iii_en.pdf"},
    {"id":"49344","name":"EU/3/20/2324: Public summary of opinion on orphan designation: 3-(((1S,2S,3R)-2,3-difluoro-1-hydroxy-7-(methylsulfonyl)-2,3-dihydro-1H-inden-4-yl)oxy)-5-fluorobenzonitrile for the treatment of von Hippel-Lindau disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2751","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202324-public-summary-opinion-orphan-designation-3-1s2s3r-23-difluoro-1-hydroxy-7-methylsulfonyl-23-dihydro-1h-inden-4-yloxy-5-fluorobenzonitrile-treatment-von-hippel-lindau-disease_en.pdf"},
    {"id":"49345","name":"EU/3/20/2325: Public summary of opinion on orphan designation: Venglustat for the treatment of GM2 gangliosidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2752","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202325-public-summary-opinion-orphan-designation-venglustat-treatment-gm2-gangliosidosis_en.pdf"},
    {"id":"49346","name":"EU/3/20/2326: Public summary of opinion on orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding glucosylceramidase beta for the treatment of Gaucher disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2753","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202326-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-encoding-glucosylceramidase-beta-treatment-gaucher-disease_en.pdf"},
    {"id":"49347","name":"EU/3/20/2327: Public summary of opinion on orphan designation: Autologous T cells transduced with lentiviral vector containing a tandem chimeric antigen receptor directed against CD20 and CD19","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2754","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202327-public-summary-opinion-orphan-designation-autologous-t-cells-transduced-lentiviral-vector-containing-tandem-chimeric-antigen-receptor-directed-against-cd20-and-cd19_en.pdf"},
    {"id":"49348","name":"EU/3/20/2328: Public summary of opinion on orphan designation: Human frataxin fused to TAT cell-penetrating peptide for the treatment of Friedreich's ataxia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2020-11-25T01:00:00Z","reference_number":"EMADOC-628903358-2755","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202328-public-summary-opinion-orphan-designation-human-frataxin-fused-tat-cell-penetrating-peptide-treatment-friedreichs-ataxia_en.pdf"},
    {"id":"49349","name":"EU/3/20/2329: Public summary of opinion on orphan designation: Infigratinib for the treatment of cholangiocarcinoma","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-11-25T01:00:00Z","last_updated_date":"2022-11-08T10:44:00Z","reference_number":"EMADOC-628903358-2757","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202329-public-summary-opinion-orphan-designation-infigratinib-treatment-cholangiocarcinoma_en.pdf"},
    {"id":"49374","name":"Clobetasol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"49413","name":"Declaration of intention to engage in an occupational activity after leaving the European Medicines Agency","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2020-12-01T13:45:00Z","last_updated_date":"2021-02-16T15:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/declaration-intention-engage-occupational-activity-after-leaving-european-medicines-agency_en.docx"},
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    {"id":"49432","name":"Racecadotril : List of nationally authorised medicinal products - PSUSA/00002602/202003","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-03T11:46:00Z","last_updated_date":"2020-12-03T11:46:00Z","reference_number":"EMA/646224/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/racecadotril-list-nationally-authorised-medicinal-products-psusa00002602202003_en.pdf"},
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    {"id":"49441","name":"Presentation - Proposal for DARWIN EU (Data Analytics and Real World Interrogation Network) (P.Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T14:38:00Z","last_updated_date":"2020-12-04T14:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-darwin-eu-data-analytics-and-real-world-interrogation-network-parlett-ema_en.pdf"},
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    {"id":"49443","name":"Presentation - Big data challenges - Academia perspectives","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T14:38:00Z","last_updated_date":"2020-12-04T14:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-challenges-academia-perspectives_en.pdf"},
    {"id":"49444","name":"Presentation - EMA’s targeted consultation on data protection and secondary use of data for medicines and public health purposes - Summary of stakeholder survey (S.Brosch, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T14:38:00Z","last_updated_date":"2020-12-04T14:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-targeted-consultation-data-protection-and-secondary-use-data-medicines-and-public-health-purposes-summary-stakeholder-survey-sbrosch-ema_en.pdf"},
    {"id":"49445","name":"Presentation - Q&As on data protection and the secondary use of personal data for medicines development and public health purposes (O. Eotvos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T14:38:00Z","last_updated_date":"2020-12-04T14:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qas-data-protection-and-secondary-use-personal-data-medicines-development-and-public-health-purposes-o-eotvos-ema_en.pdf"},
    {"id":"49446","name":"Report - Workshop on the application of the General Data Protection Regulation (GDPR) in the area of health and Secondary Use of Data for Medicines and Public Health Purposes","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T15:05:00Z","last_updated_date":"2020-12-04T15:05:00Z","reference_number":"EMA/532436/2020","document_url":"https://www.ema.europa.eu/en/documents/report/report-workshop-application-general-data-protection-regulation-gdpr-area-health-and-secondary-use-data-medicines-and-public-health-purposes_en.pdf"},
    {"id":"49447","name":"Yarrow herb: Summary for the public","type":"herbal-summary","status":"Adopted","consultation_date":"","first_published_date":"2020-12-03T15:12:00Z","last_updated_date":"2020-12-03T15:12:00Z","reference_number":"EMA/513753/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-summary/yarrow-herb-summary-public_en.pdf"},
    {"id":"49448","name":"Ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine : List of nationally authorised medicinal products - PSUSA/00010649/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-03T15:33:00Z","last_updated_date":"2020-12-03T15:33:00Z","reference_number":"EMA/649664/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/ibuprofen-ibuprofen-lysine-not-indicated-ductus-arteriosus-ibuprofen-caffeine-list-nationally-authorised-medicinal-products-psusa00010649202002_en.pdf"},
    {"id":"49450","name":"Vancomycin: List of nationally authorised medicinal products - PSUSA/00003097/202001","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-03T16:11:00Z","last_updated_date":"2020-12-03T16:11:00Z","reference_number":"EMA/647607/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/vancomycin-list-nationally-authorised-medicinal-products-psusa00003097202001_en.pdf"},
    {"id":"49451","name":"Vancomycin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"49460","name":"Aceclofenac: List of nationally authorised medicinal products - PSUSA/00000022/202003","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T13:39:00Z","last_updated_date":"2020-12-04T13:39:00Z","reference_number":"EMA/646694/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/aceclofenac-list-nationally-authorised-medicinal-products-psusa00000022202003_en.pdf"},
    {"id":"49462","name":"Phenol: List of nationally authorised medicinal products - PSUSA/00009256/202004","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-04T17:30:00Z","last_updated_date":"2020-12-04T17:30:00Z","reference_number":"EMA/646700/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/phenol-list-nationally-authorised-medicinal-products-psusa00009256202004_en.pdf"},
    {"id":"49463","name":"Reboxetine : List of nationally authorised medicinal products - PSUSA/00002615/202004","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-07T09:24:00Z","last_updated_date":"2020-12-07T09:24:00Z","reference_number":"EMA/656698/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/reboxetine-list-nationally-authorised-medicinal-products-psusa00002615202004_en.pdf"},
    {"id":"49465","name":"Letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-12-08T12:00:00Z","last_updated_date":"2020-12-08T12:00:00Z","reference_number":"EMA/308793/2020","document_url":"https://www.ema.europa.eu/en/documents/other/letter-ema-conditions-making-available-reports-suspected-adverse-reactions-ema-whoumc_en.pdf"},
    {"id":"49466","name":"Response from WHO to letter from EMA on conditions for making available reports of suspected adverse reactions by EMA to WHO/UMC","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-12-08T12:00:00Z","last_updated_date":"2020-12-08T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/response-who-letter-ema-conditions-making-available-reports-suspected-adverse-reactions-ema-whoumc_en.pdf"},
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    {"id":"49473","name":"CHMP summary of positive opinion for Mosquirix","type":"outside-EU-smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2015-07-24T11:50:00Z","last_updated_date":"2015-07-24T11:50:00Z","reference_number":"EMA/CHMP/464758/2015","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-smop-initial/chmp-summary-positive-opinion-mosquirix_en.pdf"},
    {"id":"49474","name":"Withdrawal letter: Artobend","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2020-12-11T12:00:00Z","last_updated_date":"2020-12-11T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-artobend_en.pdf"},
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    {"id":"49477","name":"European Union Medicines Agencies Network Strategy to 2025 - Protecting public health at a time of rapid change","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-12-08T14:00:00Z","last_updated_date":"2020-12-08T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-union-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf"},
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    {"id":"49544","name":"Presentation - How are COVID-19 vaccines developed? (Marco Cavaleri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-11T12:00:00Z","last_updated_date":"2020-12-11T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-are-covid-19-vaccines-developed-marco-cavaleri_en.pdf"},
    {"id":"49545","name":"Report of industry stakeholders webinar on the UK withdrawal from the European Union - End of transition period","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-12-11T15:00:00Z","last_updated_date":"2020-12-11T15:00:00Z","reference_number":"EMA/654054/2020","document_url":"https://www.ema.europa.eu/en/documents/report/report-industry-stakeholders-webinar-uk-withdrawal-european-union-end-transition-period_en.pdf"},
    {"id":"49546","name":"Addendum to assessment report on Chamaemelum nobile (L.) All. (Anthemis nobilis L.), flos","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2020-12-14T15:12:00Z","last_updated_date":"2020-12-14T15:12:00Z","reference_number":"EMA/HMPC/439694/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-chamaemelum-nobile-l-all-anthemis-nobilis-l-flos_en.pdf"},
    {"id":"49549","name":"List of participants of the EMA Roundtable with Stakeholders on the 15-year anniversary of the SME regulation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T10:19:00Z","last_updated_date":"2020-12-15T10:19:00Z","reference_number":"EMA/669499/2020","document_url":"https://www.ema.europa.eu/en/documents/other/list-participants-ema-roundtable-stakeholders-15-year-anniversary-sme-regulation_en.pdf"},
    {"id":"49550","name":"Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2020-12-15T12:00:00Z","reference_number":"EMA/277477/2020","document_url":"https://www.ema.europa.eu/en/documents/other/outcome-sme-office-survey-implementation-sme-regulation-commission-regulation-ec-no-20492005_en.pdf-0"},
    {"id":"49551","name":"Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T10:19:00Z","last_updated_date":"2020-12-15T10:19:00Z","reference_number":"EMA/277477/2020","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-sme-office-survey-implementation-sme-regulation-commission-regulation-ec-no-20492005_en.pdf"},
    {"id":"49552","name":"Presentation - SME Strategy for sustainable, digital and resilient industrial ecosystems in Europe (M. Nyman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2020-12-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-strategy-sustainable-digital-and-resilient-industrial-ecosystems-europe-m-nyman_en.pdf"},
    {"id":"49553","name":"Presentation - SME participation in EU-funded research (S. Hogan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T10:19:00Z","last_updated_date":"2020-12-15T10:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-participation-eu-funded-research-s-hogan_en.pdf"},
    {"id":"49554","name":"Presentation - EIB support to the life science sector (Y. Zhang)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2020-12-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eib-support-life-science-sector-y-zhang_en.pdf"},
    {"id":"49555","name":"Presentation - Key achievements of the EMA’s SME regulation (L. Enes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2021-07-09T11:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-achievements-emas-sme-regulation-l-enes_en.pdf"},
    {"id":"49556","name":"Presentation - Supporting Innovation through Regulation and Science (L. O’Dwyer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T10:19:00Z","last_updated_date":"2020-12-15T10:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-supporting-innovation-through-regulation-and-science-l-odwyer_en.pdf"},
    {"id":"49557","name":"Report on the European Medicines Agency roundtable with stakeholders - 15 years supporting SMEs","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T10:19:00Z","last_updated_date":"2020-12-15T10:19:00Z","reference_number":"EMA/671119/2020","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-medicines-agency-roundtable-stakeholders-15-years-supporting-smes_en.pdf"},
    {"id":"49558","name":"Presentation - EMA SME Survey 2020 (C. Provansal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2020-12-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-sme-survey-2020-c-provansal_en.pdf"},
    {"id":"49559","name":"Presentation - Orchard’s experience (D. Uguen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2020-12-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orchards-experience-d-uguen_en.pdf"},
    {"id":"49560","name":"Presentation - Human medicines industry organisations - Session 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:00:00Z","last_updated_date":"2020-12-15T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-human-medicines-industry-organisations-session-3_en.pdf"},
    {"id":"49561","name":"Presentation - Veterinary medicines organisations (M. Saarteinen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T10:00:00Z","last_updated_date":"2020-12-15T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-medicines-organisations-m-saarteinen_en.pdf"},
    {"id":"49563","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 10-13 November 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-12-14T17:57:00Z","last_updated_date":"2020-12-14T17:57:00Z","reference_number":"EMA/PDCO/629288/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-10-13-november-2020_en.pdf"},
    {"id":"49565","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - July 2020","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2020-12-15T11:46:00Z","last_updated_date":"2020-12-15T11:46:00Z","reference_number":"EMA/386443/2020","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-july-2020_en.pdf"},
    {"id":"49566","name":"Mesalazine: List of nationally authorised medicinal products - PSUSA/00001990/202002","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T11:54:00Z","last_updated_date":"2020-12-15T11:54:00Z","reference_number":"EMA/686825/2020","document_url":"https://www.ema.europa.eu/en/documents/psusa/mesalazine-list-nationally-authorised-medicinal-products-psusa00001990202002_en.pdf"},
    {"id":"49567","name":"Mesalazine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"49569","name":"Direct healthcare professional communication (DHPC): Metamizole: Risk of drug-induced liver injury","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T12:45:00Z","last_updated_date":"2020-12-15T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-metamizole-risk-drug-induced-liver-injury_en.pdf"},
    {"id":"49571","name":"Presentation - Laboratorios SYVA experience (C. Carnicer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T13:54:00Z","last_updated_date":"2020-12-15T13:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-laboratorios-syva-experience-c-carnicer_en.pdf"},
    {"id":"49572","name":"Agenda - 2020 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2020-12-16T10:53:00Z","last_updated_date":"2020-12-16T10:53:00Z","reference_number":"EMA/440708/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2020-annual-meeting-members-and-coordinating-group-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"49573","name":"Presentation - c4c Business Continuity Planning (M. Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T14:27:00Z","last_updated_date":"2020-12-15T14:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-c4c-business-continuity-planning-m-turner_en.pdf"},
    {"id":"49574","name":"Presentation - c4c update for Enpr-EMA (M. Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T14:29:00Z","last_updated_date":"2020-12-15T14:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-c4c-update-enpr-ema-m-turner_en.pdf"},
    {"id":"49575","name":"Presentation - Providing high-quality care remotely to patients with Rare Bone Diseases during COVID-19 pandemic (L. Sangiorgi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T14:59:00Z","last_updated_date":"2020-12-15T14:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-providing-high-quality-care-remotely-patients-rare-bone-diseases-during-covid-19-pandemic-l-sangiorgi_en.pdf"},
    {"id":"49576","name":"Presentation - COVID-19 and Clinical Research in Canada (T. Lacaze)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:01:00Z","last_updated_date":"2020-12-15T15:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-covid-19-and-clinical-research-canada-t-lacaze_en.pdf"},
    {"id":"49577","name":"Presentation - COVID-19 impact on paediatric clinical trials, and how to overcome the challenges. Can some new approaches be taken forward for future paediatric trials? Industry perspective (M. Dehlinger-Kremer, C. Ollivier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:03:00Z","last_updated_date":"2020-12-15T15:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-covid-19-impact-paediatric-clinical-trials-and-how-overcome-challenges-can-some-new-approaches-be-taken-forward-future-paediatric-trials-industry-perspective-m-dehlinger-kremer-c-ollivier_en.pdf"},
    {"id":"49578","name":"Presentation - ERICA - ERN rare disease research coordination & support action (L. Sangiorgi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:08:00Z","last_updated_date":"2020-12-15T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-erica-ern-rare-disease-research-coordination-support-action-l-sangiorgi_en.pdf"},
    {"id":"49579","name":"Presentation - European Paediatric Translational Research Infrastructure (EPTRI) (D. Bonifazi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:10:00Z","last_updated_date":"2020-12-15T15:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-paediatric-translational-research-infrastructure-eptri-d-bonifazi_en.pdf"},
    {"id":"49580","name":"Presentation - Evaluation of the legislation on medicines for children and rare diseases (F. D’Atri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:16:00Z","last_updated_date":"2020-12-15T15:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evaluation-legislation-medicines-children-and-rare-diseases-f-datri_en.pdf"},
    {"id":"49581","name":"Presentation - Multi-Regional Clinical Trials (MRCT) Centerand its initiative on promoting global clinical research in children (D. Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:20:00Z","last_updated_date":"2020-12-15T15:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-regional-clinical-trials-mrct-centerand-its-initiative-promoting-global-clinical-research-children-d-karres_en.pdf"},
    {"id":"49582","name":"Presentation - Multisystem inflammatory syndrome in children and adolescents (temporally related to COVID-19) (L. Fregonese)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:27:00Z","last_updated_date":"2020-12-15T15:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multisystem-inflammatory-syndrome-children-and-adolescents-temporally-related-covid-19-l-fregonese_en.pdf"},
    {"id":"49583","name":"Presentation - Pharmaceutical strategy for Europe (A. Rodiadis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:31:00Z","last_updated_date":"2020-12-15T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmaceutical-strategy-europe-rodiadis_en.pdf"},
    {"id":"49584","name":"Presentation - Preparedness for paediatric COVID vaccine trials (L. Fregonese)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:43:00Z","last_updated_date":"2020-12-15T15:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preparedness-paediatric-covid-vaccine-trials-l-fregonese_en.pdf"},
    {"id":"49585","name":"Presentation - Enpr-EMA Annual Report 2019-2020 (P. Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:44:00Z","last_updated_date":"2020-12-15T15:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-annual-report-2019-2020-p-lepola_en.pdf"},
    {"id":"49586","name":"Presentation - WG on clinical practice evidence in the labelling (S. de Wildt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:46:00Z","last_updated_date":"2020-12-15T15:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-wg-clinical-practice-evidence-labelling-s-de-wildt_en.pdf"},
    {"id":"49587","name":"Presentation - Enpr-EMA Nurse - Coordinator Working Group (V.O’Mahony, P. Dicks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-15T15:49:00Z","last_updated_date":"2020-12-15T15:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-nurse-coordinator-working-group-vomahony-p-dicks_en.pdf"},
    {"id":"49588","name":"Minutes of the 109th meeting of the Management Board: 1 October 2020","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2020-12-15T16:15:00Z","last_updated_date":"2020-12-15T16:15:00Z","reference_number":"EMA/MB/519858/2020","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-109th-meeting-management-board-1-october-2020_en.pdf"},
    {"id":"49589","name":"Agenda for the 110th meeting of the Management Board: 16-17 December 2020","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2020-12-15T17:45:00Z","last_updated_date":"2020-12-21T09:43:00Z","reference_number":"EMA/MB/547010/2020","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-110th-meeting-management-board-16-17-december-2020_en.pdf"},
    {"id":"49590","name":"Report from the 2020 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2020-12-16T10:54:00Z","last_updated_date":"2020-12-16T10:54:00Z","reference_number":"EMA/518319/2020","document_url":"https://www.ema.europa.eu/en/documents/report/report-2020-annual-meeting-members-and-coordinating-group-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"49591","name":"Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-12-16T12:54:00Z","last_updated_date":"2020-12-16T12:54:00Z","reference_number":"EMA/CHMP/176098/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/levothyroxine-tablets-125-mcg-25-mcg-50-mcg-75-mcg-100-mcg-and-200-mcg-and-additional-strengths-within-range-product-specific-bioequivalence-guidance_en.pdf"},
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    {"id":"49613","name":"Presentation - Workshop on support for orphan medicines development: European joint programme on rare diseases (Daria Julkowska)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-17T16:26:00Z","last_updated_date":"2020-12-17T16:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-support-orphan-medicines-development-european-joint-programme-rare-diseases-daria-julkowska_en.pdf"},
    {"id":"49615","name":"Presentation - Workshop on support for orphan medicines development: International rare diseases research consortium (IRDiRC) drug development guidebook (Virginie Hivert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-17T16:29:00Z","last_updated_date":"2020-12-17T16:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-support-orphan-medicines-development-international-rare-diseases-research-consortium-irdirc-drug-development-guidebook-virginie-hivert_en.pdf"},
    {"id":"49616","name":"Presentation - Workshop on support for orphan medicines development: Orphan designation and orphan medicines in the EU (Frauke Naumann-Winter, Darius Matusevicius)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-17T16:35:00Z","last_updated_date":"2020-12-17T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-support-orphan-medicines-development-orphan-designation-and-orphan-medicines-eu-frauke-naumann-winter-darius-matusevicius_en.pdf"},
    {"id":"49617","name":"Presentation - Workshop on support for orphan medicines development: Protocol assistance, PRIME and parallel distribution (Armando Magrelli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2020-12-17T16:38:00Z","last_updated_date":"2020-12-17T16:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-workshop-support-orphan-medicines-development-protocol-assistance-prime-and-parallel-distribution-armando-magrelli_en.pdf"},
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    {"id":"49649","name":"Metamizole:  List of nationally authorised medicinal products - PSUSA/00001997/202003","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2020-12-18T17:00:00Z","last_updated_date":"2020-12-18T17:00:00Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-list-nationally-authorised-medicinal-products-psusa00001997202003_en.pdf"},
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    {"id":"49997","name":"CHMP summary of positive opinion for Byfavo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-02-01T17:44:00Z","last_updated_date":"2021-02-01T17:44:00Z","reference_number":"EMA/CHMP/622868/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-byfavo_en.pdf"},
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    {"id":"50007","name":"Joining a WebEx meeting as a logged-in user: Instructions for EU Regulatory Network Users","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-02-01T10:16:00Z","last_updated_date":"2021-08-02T17:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/joining-webex-meeting-logged-user-instructions-eu-regulatory-network-users_en.pdf"},
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    {"id":"50012","name":"Questions and answers on the withdrawal of application to change the marketing authorisation for for Tecentriq (atezolizumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2021-02-01T10:55:00Z","last_updated_date":"2021-02-01T10:55:00Z","reference_number":"EMA/47544/2021","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-tecentriq-atezolizumab_en.pdf-0"},
    {"id":"50015","name":"Draft assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2021-02-01T11:30:00Z","last_updated_date":"2021-02-01T11:30:00Z","reference_number":"EMA/HMPC/509932/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-salvia-miltiorrhiza-bunge-radix-et-rhizoma-first-version_en.pdf"},
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    {"id":"50019","name":"CVMP strategy on antimicrobials 2021-2025","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-02-02T09:45:00Z","last_updated_date":"2021-02-02T09:45:00Z","reference_number":"EMA/CVMP/179874/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/cvmp-strategy-antimicrobials-2021-2025_en.pdf"},
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    {"id":"50128","name":"EU/3/20/2337: Public summary of opinion on orphan designation: Ribitol for the treatment of limb-girdle muscular dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-05-25T01:00:00Z","last_updated_date":"2021-05-25T01:00:00Z","reference_number":"EMADOC-628903358-3044","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202337-public-summary-opinion-orphan-designation-ribitol-treatment-limb-girdle-muscular-dystrophy_en.pdf"},
    {"id":"50129","name":"EU/3/20/2338: Public summary of opinion on orphan designation: Decitabine, tetrahydrouridine for the treatment of sickle cell disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-15T01:00:00Z","last_updated_date":"2021-02-15T01:00:00Z","reference_number":"EMADOC-628903358-3045","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202338-public-summary-opinion-orphan-designation-decitabine-tetrahydrouridine-treatment-sickle-cell-disease_en.pdf"},
    {"id":"50130","name":"EU/3/20/2339: Public summary of opinion on orphan designation: Leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS)","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-05-25T01:00:00Z","last_updated_date":"2021-05-25T01:00:00Z","reference_number":"EMADOC-628903358-3046","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202339-public-summary-opinion-orphan-designation-leniolisib-treatment-activated-phosphoinositide-3-kinase-delta-syndrome-apds_en.pdf"},
    {"id":"50131","name":"EU/3/20/2340: Public summary of opinion on orphan designation: 2-(2-(18F)fluoropyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine for the diagnosis of corticobasal degeneration","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-15T01:00:00Z","last_updated_date":"2021-02-15T01:00:00Z","reference_number":"EMADOC-628903358-3048","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202340-public-summary-opinion-orphan-designation-2-2-18ffluoropyridin-4-yl-9h-pyrrolo23-b45-cdipyridine-diagnosis-corticobasal-degeneration_en.pdf"},
    {"id":"50132","name":"EU/3/20/2341: Public summary of opinion on orphan designation: Autologous CD34+ cells transduced with a lentiviral vector encoding galactosidase alpha for the treatment of Fabry disease","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3047","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202341-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-lentiviral-vector-encoding-galactosidase-alpha-treatment-fabry-disease_en.pdf"},
    {"id":"50133","name":"EU/3/20/2342: Public summary of opinion on orphan designation: Highly branched poly(beta-amino ester) complexed with a nanoplasmid containing the human COL7A1 gene for the treatment of epidermolysis bullosa","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3049","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202342-public-summary-opinion-orphan-designation-highly-branched-polybeta-amino-ester-complexed-nanoplasmid-containing-human-col7a1-gene-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"50134","name":"EU/3/20/2343: Public summary of opinion on orphan designation: Retifanlimab for the treatment of anal cancer","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3050","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202343-public-summary-opinion-orphan-designation-retifanlimab-treatment-anal-cancer_en.pdf"},
    {"id":"50135","name":"EU/3/20/2344: Public summary of opinion on orphan designation: Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3051","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202344-public-summary-opinion-orphan-designation-autologous-peripheral-blood-t-cells-cd4-and-cd8-selected-and-cd3-and-cd28-activated-transduced-retroviral-vector-expressing-anti-cd19-cd28cd3-zeta_en.pdf"},
    {"id":"50136","name":"EU/3/20/2345: Public summary of opinion on orphan designation: Sparsentan for the treatment of primary IgA nephropathy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3052","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202345-public-summary-opinion-orphan-designation-sparsentan-treatment-primary-iga-nephropathy_en.pdf"},
    {"id":"50138","name":"EU/3/20/2346: Public summary of opinion on orphan designation: Adeno-associated virus serotype hu68 containing the human GLB1 gene for the treatment of GM1 gangliosidosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3053","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202346-public-summary-opinion-orphan-designation-adeno-associated-virus-serotype-hu68-containing-human-glb1-gene-treatment-gm1-gangliosidosis_en.pdf"},
    {"id":"50139","name":"EU/3/20/2347: Public summary of opinion on orphan designation: Trehalose for the treatment of neuronal ceroid lipofuscinosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-16T01:00:00Z","last_updated_date":"2021-02-16T01:00:00Z","reference_number":"EMADOC-628903358-3054","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202347-public-summary-opinion-orphan-designation-trehalose-treatment-neuronal-ceroid-lipofuscinosis_en.pdf"},
    {"id":"50141","name":"EU/3/20/2349: Public summary of opinion on orphan designation: Miglustat for the treatment of neuronal ceroid lipofuscinosis","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-18T01:00:00Z","last_updated_date":"2021-02-18T01:00:00Z","reference_number":"EMADOC-628903358-3056","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202349-public-summary-opinion-orphan-designation-miglustat-treatment-neuronal-ceroid-lipofuscinosis_en.pdf"},
    {"id":"50142","name":"EU/3/20/2350: Public summary of opinion on orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1-[3-[[3-(2,3-dihydroxypropoxy)propyl]amino]-3-oxopropyl]-2,5-dioxo-3-pyrrolidinyl]thio]hexyl]amino]ethyl]amino]...","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-18T01:00:00Z","last_updated_date":"2021-02-18T01:00:00Z","reference_number":"EMADOC-628903358-3058","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202350-public-summary-opinion-orphan-designation-polyoxy-12-ethanediyl-alpha-hydro-omega-methoxy-ether-n-2-6-1-3-3-23-dihydroxypropoxypropylamino-3-oxopropyl-25-dioxo-3_en.pdf"},
    {"id":"50143","name":"EU/3/20/2351: Public summary of opinion on orphan designation: Adeno-associated virus serotype 5 containing the human RDH12 gene for the treatment of RDH12 mutation associated retinal dystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2021-02-18T01:00:00Z","last_updated_date":"2021-02-18T01:00:00Z","reference_number":"EMADOC-628903358-3057","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202351-public-summary-opinion-orphan-designation-adeno-associated-virus-serotype-5-containing-human-rdh12-gene-treatment-rdh12-mutation-associated-retinal-dystrophy_en.pdf"},
    {"id":"50146","name":"Addendum to Assessment report on Lavandula angustifolia Mill. (L. officinalis Chaix), flos","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2021-02-11T16:51:00Z","last_updated_date":"2021-02-11T16:51:00Z","reference_number":"EMA/HMPC/487394/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-lavandula-angustifolia-mill-l-officinalis-chaix-flos_en.pdf"},
    {"id":"50147","name":"Amfepramone-containing medicinal products Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T12:00:00Z","last_updated_date":"2021-02-12T12:00:00Z","reference_number":"EMA/53585/2021","document_url":"https://www.ema.europa.eu/en/documents/referral/amfepramone-containing-medicinal-products-article-31-referral-review-started_en.pdf"},
    {"id":"50148","name":"Amfepramone-containing medicinal products Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T12:00:00Z","last_updated_date":"2021-02-12T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/amfepramone-containing-medicinal-products-article-31-referral-notification_en.pdf"},
    {"id":"50149","name":"Amfepramone-containing medicinal products Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T12:00:00Z","last_updated_date":"2021-02-12T12:00:00Z","reference_number":"EMA/91464/2021","document_url":"https://www.ema.europa.eu/en/documents/referral/amfepramone-containing-medicinal-products-article-31-referral-annex-i_en.pdf"},
    {"id":"50150","name":"Amfepramone-containing medicinal products Article-31 referral - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T12:00:00Z","last_updated_date":"2021-02-12T12:00:00Z","reference_number":"EMA/PRAC/51715/2021","document_url":"https://www.ema.europa.eu/en/documents/referral/amfepramone-containing-medicinal-products-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"50151","name":"Amfepramone-containing medicinal products Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T12:00:00Z","last_updated_date":"2022-09-02T13:09:00Z","reference_number":"EMA/PRAC/51714/2021 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/referral/amfepramone-containing-medicinal-products-article-31-referral-timetable-procedure_en.pdf"},
    {"id":"50152","name":"PRAC statistics: February 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T12:32:00Z","last_updated_date":"2021-02-12T12:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-february-2021_en.pdf"},
    {"id":"50153","name":"Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): batch-specific product recall","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-02-12T14:14:00Z","last_updated_date":"2021-02-12T14:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-respreeza-human-alpha-1-proteinase-inhibitor-batch-specific-product-recall_en.pdf"},
    {"id":"50164","name":"EU/3/20/2353: Public summary of opinion on orphan designation - Zanidatamab for the treatment of gastric cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T11:29:00Z","last_updated_date":"2021-02-15T11:29:00Z","reference_number":"EMADOC-628903358-3455","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202353-public-summary-opinion-orphan-designation-zanidatamab-treatment-gastric-cancer_en.pdf"},
    {"id":"50165","name":"EU/3/20/2354: Public summary of opinion on orphan designation - Alisitol, retinol palmitate, zinc gluconate for the treatment of microvillus inclusion disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T12:09:00Z","last_updated_date":"2021-02-15T12:09:00Z","reference_number":"EMADOC-628903358-3456","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202354-public-summary-opinion-orphan-designation-alisitol-retinol-palmitate-zinc-gluconate-treatment-microvillus-inclusion-disease_en.pdf"},
    {"id":"50166","name":"EU/3/20/2355: Public summary of opinion on orphan designation - Anti-(pancreatic adenocarcinoma upregulated factor) IgG1 humanised monoclonal antibody for the treatment of pancreatic cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T12:21:00Z","last_updated_date":"2021-02-15T12:21:00Z","reference_number":"EMADOC-628903358-3457","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202355-public-summary-opinion-orphan-designation-anti-pancreatic-adenocarcinoma-upregulated-factor-igg1-humanised-monoclonal-antibody-treatment-pancreatic-cancer_en.pdf"},
    {"id":"50167","name":"EU/3/20/2356: Public summary of opinion on orphan designation - Autologous CD34+ cells transduced ex vivo with a lentiviral vector containing a modified gamma-globin gene for the treatment of sickle cell disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T12:32:00Z","last_updated_date":"2022-09-16T14:59:00Z","reference_number":"EMADOC-628903358-3459","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202356-public-summary-opinion-orphan-designation-autologous-cd34-cells-transduced-ex-vivo-lentiviral-vector-containing-modified-gamma-globin-gene-treatment-sickle-cell-disease_en.pdf"},
    {"id":"50168","name":"EU/3/20/2357: Public summary of opinion on orphan designation - Tislelizumab for the treatment of oesophageal cancer","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T12:41:00Z","last_updated_date":"2021-02-15T12:41:00Z","reference_number":"EMADOC-628903358-3458","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202357-public-summary-opinion-orphan-designation-tislelizumab-treatment-oesophageal-cancer_en.pdf"},
    {"id":"50169","name":"EU/3/20/2358: Public summary of opinion on orphan designation - L-pyroglutamyl-L-asparaginyl-L-prolyl-D-tyrosyl-D-tryptophan amide for the treatment of amyotrophic lateral sclerosis","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T12:58:00Z","last_updated_date":"2021-02-15T12:58:00Z","reference_number":"EMADOC-628903358-3460","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202358-public-summary-opinion-orphan-designation-l-pyroglutamyl-l-asparaginyl-l-prolyl-d-tyrosyl-d-tryptophan-amide-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"50170","name":"EU/3/20/2359: Public summary of opinion for orphan designation - Adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene for the treatment of frontotemporal dementia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T14:31:00Z","last_updated_date":"2021-02-15T14:31:00Z","reference_number":"EMADOC-628903358-3461","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202359-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-expressing-codon-optimized-human-grn-gene-treatment-frontotemporal-dementia_en.pdf"},
    {"id":"50171","name":"Public statement on Udenyca: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T15:30:00Z","last_updated_date":"2021-02-15T15:30:00Z","reference_number":"EMA/561886/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-udenyca-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"50172","name":"EU/3/20/2360: Public summary of opinion for orphan designation - Triheptanoin for the treatment of carnitine palmitoyltransferase I deficiency","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T16:03:00Z","last_updated_date":"2021-02-15T16:03:00Z","reference_number":"EMADOC-628903358-3462","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202360-public-summary-opinion-orphan-designation-triheptanoin-treatment-carnitine-palmitoyltransferase-i-deficiency_en.pdf"},
    {"id":"50173","name":"EU/3/20/2361: Public summary of opinion for orphan designation - Perflubron for the treatment of congenital pulmonary hypoplasia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T16:47:00Z","last_updated_date":"2021-02-15T16:47:00Z","reference_number":"EMADOC-628903358-3463","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202361-public-summary-opinion-orphan-designation-perflubron-treatment-congenital-pulmonary-hypoplasia_en.pdf"},
    {"id":"50174","name":"EU/3/20/2362: Public summary of opinion for orphan designation - Autologous bone marrow derived CD34+ cells transduced ex vivo with a self-inactivating lentiviral vector containing a normal version of the coding region of the IL2RG gene","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T17:01:00Z","last_updated_date":"2021-02-15T17:01:00Z","reference_number":"EMADOC-628903358-3464","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202362-public-summary-opinion-orphan-designation-autologous-bone-marrow-derived-cd34-cells-transduced-ex-vivo-self-inactivating-lentiviral-vector-containing-normal-version-coding-region-il2rg-gene_en.pdf"},
    {"id":"50175","name":"EU/3/20/2363: Public summary of opinion on orphan designation - 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide, sodium chloride solution 4.2% (w/v) for th","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T17:10:00Z","last_updated_date":"2021-02-15T17:10:00Z","reference_number":"EMADOC-628903358-3465","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202363-public-summary-opinion-orphan-designation-35-diamino-6-chloro-n-n-4-4-2-hexyl2s3r4r5r-23456-pentahydroxyhexylaminoethoxyphenylbutyl-carbamimidoylpyrazine-2-carboxamide-sodium-chloride_en.pdf"},
    {"id":"50176","name":"EU/3/20/2364: Public summary of opinion on orphan designation - DNA plasmid encoding human transferrin gene for the treatment of retinitis pigmentosa","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-02-15T17:20:00Z","last_updated_date":"2021-02-15T17:20:00Z","reference_number":"EMADOC-628903358-3466","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202364-public-summary-opinion-orphan-designation-dna-plasmid-encoding-human-transferrin-gene-treatment-retinitis-pigmentosa_en.pdf"},
    {"id":"50180","name":"Agenda - PCWP/HCPWP joint meeting on 2-3 March 2021","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-02-16T09:36:00Z","last_updated_date":"2021-02-22T14:19:00Z","reference_number":"EMA/62114/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pcwphcpwp-joint-meeting-2-3-march-2021_en.pdf"},
    {"id":"50183","name":"Audit checklist - Interpretation guide","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-02-16T12:16:00Z","last_updated_date":"2021-02-16T12:16:00Z","reference_number":"EMA/92823/2021","document_url":"https://www.ema.europa.eu/en/documents/other/audit-checklist-interpretation-guide_en.pdf"},
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    {"id":"50268","name":"Public statement on Truberzi: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2021-02-25T11:11:00Z","last_updated_date":"2021-02-25T11:11:00Z","reference_number":"EMA/670383/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-truberzi-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"50269","name":"Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-02-25T13:58:00Z","last_updated_date":"2021-02-25T13:58:00Z","reference_number":"EMA/117973/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-requirements-vaccines-intended-provide-protection-against-variant-strains-sars-cov-2_en.pdf"},
    {"id":"50270","name":"CHMP post-authorisation summary of positive opinion for Quofenix (II-03)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T13:57:00Z","last_updated_date":"2021-02-26T13:57:00Z","reference_number":"EMA/CHMP/99783/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-quofenix-ii-03_en.pdf"},
    {"id":"50271","name":"CHMP summary of positive opinion for Orladeyo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T14:08:00Z","last_updated_date":"2021-02-26T14:08:00Z","reference_number":"EMA/CHMP/86405/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-orladeyo_en.pdf"},
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    {"id":"50273","name":"CHMP post-authorisation summary of positive opinion for Epidyolex (II-05)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T14:16:00Z","last_updated_date":"2021-02-26T14:16:00Z","reference_number":"EMA/CHMP/51910/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-epidyolex-ii-05_en.pdf"},
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    {"id":"50285","name":"Varilrix Article 30 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T12:00:00Z","last_updated_date":"2021-05-18T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/varilrix-article-30-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/varilrix-article-30-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/varilrix-article-30-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/varilrix-article-30-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/varilrix-article-30-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/varilrix-article-30-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/varilrix-article-30-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/varilrix-article-30-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/varilrix-article-30-referral-annex-iii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/varilrix-article-30-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/varilrix-article-30-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/varilrix-article-30-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/varilrix-article-30-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/varilrix-article-30-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/varilrix-article-30-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/varilrix-article-30-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/varilrix-article-30-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/varilrix-article-30-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/varilrix-article-30-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/varilrix-article-30-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/varilrix-article-30-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/varilrix-article-30-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/varilrix-article-30-referral-annex-iii_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/varilrix-article-30-referral-annex-iii_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/varilrix-article-30-referral-annex-iii_no.pdf"}},
    {"id":"50286","name":"Clonazepam: List of nationally authorised medicinal products - PSUSA/00000812/202006","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T09:12:00Z","last_updated_date":"2021-02-26T09:12:00Z","reference_number":"EMA/112475/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/clonazepam-list-nationally-authorised-medicinal-products-psusa00000812202006_en.pdf"},
    {"id":"50287","name":"CHMP summary of positive opinion for Abevmy","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T12:00:00Z","last_updated_date":"2021-02-26T12:00:00Z","reference_number":"EMA/CHMP/87659/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-abevmy_en.pdf"},
    {"id":"50288","name":"CHMP summary of positive opinion for Lextemy","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T12:00:00Z","last_updated_date":"2021-02-26T12:00:00Z","reference_number":"EMA/CHMP/87640/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lextemy_en.pdf"},
    {"id":"50289","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 February 2021","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T12:00:00Z","last_updated_date":"2021-02-26T12:00:00Z","reference_number":"EMA/CHMP/SAWP/123436/2021","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-22-25-february-2021_en.pdf"},
    {"id":"50290","name":"Varilrix Article 30 referral - Use of Varilrix (live attenuated varicella virus [OKA strain]) to be harmonised in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T12:00:00Z","last_updated_date":"2021-06-09T13:19:00Z","reference_number":"EMA/104511/2021","document_url":"https://www.ema.europa.eu/en/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/varilrix-article-30-referral-use-varilrix-live-attenuated-varicella-virus-oka-strain-be-harmonised-eu_sv.pdf"}},
    {"id":"50291","name":"Questions and answers on the refusal of a change to the marketing authorisation for Elebrato Ellipta (fluticasone furoate / umeclidinium / vilanterol)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T11:55:00Z","last_updated_date":"2021-02-26T11:55:00Z","reference_number":"EMA/126141/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-elebrato-ellipta-fluticasone-furoate-umeclidinium-vilanterol_en.pdf"},
    {"id":"50292","name":"Questions and answers on the refusal of a change to the marketing authorisation for Temybric Ellipta (fluticasone furoate / umeclidinium / vilanterol)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T12:00:00Z","last_updated_date":"2022-11-24T15:37:00Z","reference_number":"EMA/126142/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-temybric-ellipta-fluticasone-furoate-umeclidinium-vilanterol_en.pdf"},
    {"id":"50293","name":"Questions and answers on the refusal of a change to the marketing authorisation for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T12:23:00Z","last_updated_date":"2021-02-26T12:23:00Z","reference_number":"EMA/123532/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-trelegy-ellipta-fluticasone-furoate-umeclidinium-vilanterol_en.pdf"},
    {"id":"50294","name":"CHMP position statement on quality and safety assessment for the Plasma Master File (PMF) certification with regard to donor deferral criteria for sexual risk behaviour","type":"position","status":"Adopted","consultation_date":"","first_published_date":"2021-02-26T15:06:00Z","last_updated_date":"2021-02-26T15:06:00Z","reference_number":"EMA/CHMP/BWP/76987/2021","document_url":"https://www.ema.europa.eu/en/documents/position/chmp-position-statement-quality-and-safety-assessment-plasma-master-file-pmf-certification-regard-donor-deferral-criteria-sexual-risk-behaviour_en.pdf"},
    {"id":"50301","name":"Presentation - CTIS benefits - SME and Academia Clinical Trials Information System (CTIS) training (F.Sweeney, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-benefits-sme-and-academia-clinical-trials-information-system-ctis-training-fsweeney-ema_en.pdf"},
    {"id":"50307","name":"Presentation - Clinical Trials Regulation, what is changing in practice - SME and Academia Clinical Trials Information System (CTIS) training (S.Kromar, EORTC))","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-regulation-what-changing-practice-sme-and-academia-clinical-trials-information-system-ctis-training-skromar-eortc_en.pdf"},
    {"id":"50308","name":"Presentation - Sponsor user management - SME and Academia Clinical Trials Information System (CTIS) training (S.Kromar, EORTC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sponsor-user-management-sme-and-academia-clinical-trials-information-system-ctis-training-skromar-eortc_en.pdf"},
    {"id":"50309","name":"Presentation - User access management - SME and Academia Clinical Trials Information System (CTIS) training (A.Rodriquez, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-user-access-management-sme-and-academia-clinical-trials-information-system-ctis-training-arodriquez-ema_en.pdf"},
    {"id":"50310","name":"Presentation - Introduction to Clinical Trials Regulation - SME and Academia Clinical Trials Information System (CTIS) training (A.Mathieu-Mendes, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-clinical-trials-regulation-sme-and-academia-clinical-trials-information-system-ctis-training-amathieu-mendes-ec_en.pdf"},
    {"id":"50311","name":"Presentation - Overview of CTIS - SME and Academia Clinical Trials Information System (CTIS) training","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-ctis-sme-and-academia-clinical-trials-information-system-ctis-training_en.pdf"},
    {"id":"50312","name":"Presentation - Sponsor roles and permissions in CTIS - SME and Academia Clinical Trials Information System (CTIS) training (A.Rodriguez, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sponsor-roles-and-permissions-ctis-sme-and-academia-clinical-trials-information-system-ctis-training-arodriguez-ema_en.pdf"},
    {"id":"50313","name":"Presentation - Trial centric and organisation centric approach in CTIS - SME and Academia Clinical Trials Information System (CTIS) training (A.Seidel-Glätzer, University Hospital Heidelberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-02-26T16:59:00Z","last_updated_date":"2021-02-26T16:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-trial-centric-and-organisation-centric-approach-ctis-sme-and-academia-clinical-trials-information-system-ctis-training-aseidel-glatzer-university-hospital-heidelberg_en.pdf"},
    {"id":"50325","name":"COMP meeting report on the review of applications for orphan designation: February 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-03-01T13:52:00Z","last_updated_date":"2021-03-01T13:52:00Z","reference_number":"EMA/COMP/109507/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-february-2021_en.pdf"},
    {"id":"50327","name":"Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-03-01T15:21:00Z","last_updated_date":"2021-03-01T15:21:00Z","reference_number":"EMA/CVMP/AWP/842786/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-aminopenicillins-and-their-beta-lactamase-inhibitor-combinations-animals-european-union-development-resistance-and-impact-human-and-animal-health-first-version_en.pdf"},
    {"id":"50328","name":"Overview of comments received on 'Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-03-01T15:31:00Z","last_updated_date":"2021-03-01T15:31:00Z","reference_number":"EMA/CVMP/AWP/902538/2019","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-use-aminopenicillins-and-their-beta-lactamase-inhibitor-combinations-animals-european-union-development-resistance-and-impact-human-and-animal-health-first_en.pdf"},
    {"id":"50332","name":"Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-03-01T16:39:00Z","last_updated_date":"2021-03-01T16:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-antimicrobial-resistance-environment-considerations-current-and-future-risk-assessment-veterinary-medicinal-products-first-version_en.pdf"},
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    {"id":"50676","name":"Final European Union herbal monograph on Species amarae","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2021-03-23T11:38:00Z","last_updated_date":"2021-03-23T11:38:00Z","reference_number":"EMA/HMPC/44543/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-species-amarae_en.pdf"},
    {"id":"50678","name":"Final list of references supporting the assessment of Species amarae","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2021-03-23T11:45:00Z","last_updated_date":"2021-03-23T11:45:00Z","reference_number":"EMA/HMPC/97854/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-species-amarae_en.pdf"},
    {"id":"50679","name":"Opinion of the HMPC on a European Union herbal monograph on Species amarae","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2021-03-23T11:46:00Z","last_updated_date":"2021-03-23T11:46:00Z","reference_number":"EMA/HMPC/649746/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-species-amarae_en.pdf"},
    {"id":"50680","name":"Overview of comments received on European Union Draft Herbal Monograph on Species amarae (EMA/HMPC/44543/2018)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2021-03-23T11:48:00Z","last_updated_date":"2021-03-23T11:48:00Z","reference_number":"EMA/HMPC/487459/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-draft-herbal-monograph-species-amarae-emahmpc445432018_en.pdf"},
    {"id":"50684","name":"Agenda - Joint HMA/EMA workshop on artificial intelligence in medicines regulation","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-03-24T09:20:00Z","last_updated_date":"2021-04-19T09:39:00Z","reference_number":"EMA/176509/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-hmaema-workshop-artificial-intelligence-medicines-regulation_en.pdf"},
    {"id":"50685","name":"COMP meeting report on the review of applications for orphan designation: March 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-03-24T09:29:00Z","last_updated_date":"2021-03-24T09:29:00Z","reference_number":"EMA/COMP/170529/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-march-2021_en.pdf"},
    {"id":"50687","name":"Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-03-24T10:00:00Z","last_updated_date":"2021-03-24T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vaxzevria-previously-covid-19-vaccine-astrazeneca-risk-thrombocytopenia-and-coagulation-disorders_en.pdf"},
    {"id":"50689","name":"Lidocaine hydrochloride/methylprednisolone acetate: List of nationally authorised medicinal products - PSUSA/00001879/202008","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-03-24T12:20:00Z","last_updated_date":"2021-03-24T12:20:00Z","reference_number":"EMA/164837/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-hydrochloridemethylprednisolone-acetate-list-nationally-authorised-medicinal-products-psusa00001879202008_en.pdf"},
    {"id":"50690","name":"Direct healthcare professional communication (DHPC): Xeljanz (tofacitinib): Initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-03-24T12:23:00Z","last_updated_date":"2021-03-24T12:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-xeljanz-tofacitinib-initial-clinical-trial-results-increased-risk-major-adverse-cardiovascular-events-and-malignancies-excluding-nmsc-use-tofacitinib_en.pdf"},
    {"id":"50693","name":"Speakers - European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-03-24T16:14:00Z","last_updated_date":"2021-03-24T16:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/speakers-european-medicines-agency-animalhealtheurope-veterinary-medicines-info-day-2021_en.pdf"},
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    {"id":"50698","name":"Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-03-25T11:10:00Z","last_updated_date":"2021-03-25T11:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-tecentriq-atezolizumab-risk-severe-cutaneous-adverse-reactions-scars_en.pdf"},
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    {"id":"50703","name":"Minutes - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting (March 2021)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2021-03-25T15:58:00Z","last_updated_date":"2021-03-25T15:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-network-paediatric-research-european-medicines-agency-enpr-ema-coordinating-group-and-networks-meeting-march-2021_en.pdf"},
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    {"id":"50798","name":"(Superseded) European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web-based sales and animal population data collection protocol (2020)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2019-07-16T11:39:00Z","last_updated_date":"2020-06-19T12:01:00Z","reference_number":"EMA/210691/2015 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/other/superseded-european-surveillance-veterinary-antimicrobial-consumption-esvac-web-based-sales-and-animal-population-data-collection-protocol-2020_en.pdf"},
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    {"id":"50817","name":"Human medicines highlights - April 2021","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-04-14T09:55:00Z","last_updated_date":"2021-04-14T09:55:00Z","reference_number":"Issue 145","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-april-2021_en.pdf"},
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    {"id":"50856","name":"Octreotide: List of nationally authorised medicinal products - PSUSA/00002201/202006","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-04-15T13:47:00Z","last_updated_date":"2021-04-15T13:47:00Z","reference_number":"EMA/203553/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/octreotide-list-nationally-authorised-medicinal-products-psusa00002201202006_en.pdf"},
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    {"id":"50878","name":"Draft Assessment report on Trigonella foenum-graecum L., semen - Revision 1","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2021-04-16T08:59:00Z","last_updated_date":"2021-04-16T08:59:00Z","reference_number":"EMA/HMPC/179590/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-trigonella-foenum-graecum-l-semen-revision-1_en.pdf"},
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    {"id":"51216","name":"CHMP post-authorisation summary of positive opinion for Zomarist (WS-1937-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-05-21T17:19:00Z","last_updated_date":"2021-05-21T17:19:00Z","reference_number":"EMA/283696/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zomarist-ws-1937-g_en.pdf"},
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    {"id":"51223","name":"CHMP summary of positive opinion for Imcivree","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-05-21T12:00:00Z","last_updated_date":"2021-05-21T12:00:00Z","reference_number":"EMA/CHMP/270677/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imcivree_en.pdf"},
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    {"id":"51226","name":"CHMP post-authorisation summary of positive opinion for Darzalex (II-43, II-44)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-05-21T12:15:00Z","last_updated_date":"2021-05-21T12:15:00Z","reference_number":"EMA/CHMP/278065/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-ii-43-ii-44_en.pdf"},
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    {"id":"51229","name":"CHMP post-authorisation summary of positive opinion for Evotaz (II-38)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-05-21T15:36:00Z","last_updated_date":"2021-05-21T15:36:00Z","reference_number":"EMA/289551/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-evotaz-ii-38_en.pdf"},
    {"id":"51230","name":"EU/3/20/2369: Public summary of opinion on orphan designation: Sotatercept for the treatment of pulmonary arterial hypertension","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T15:46:00Z","last_updated_date":"2021-05-21T15:46:00Z","reference_number":"EMADOC-628903358-3726","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202369-public-summary-opinion-orphan-designation-sotatercept-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"51232","name":"EU/3/20/2370: Public summary of opinion on orphan designation: Tremelimumab for the treatment of hepatocellular carcinoma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T15:58:00Z","last_updated_date":"2022-12-09T13:53:00Z","reference_number":"EMADOC-628903358-3728","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202370-public-summary-opinion-orphan-designation-tremelimumab-treatment-hepatocellular-carcinoma_en.pdf"},
    {"id":"51233","name":"COMP meeting report on the review of applications for orphan designation: May 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T16:25:00Z","last_updated_date":"2021-05-21T16:25:00Z","reference_number":"EMA/COMP/279124/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-may-2021_en.pdf"},
    {"id":"51234","name":"Presentation - Data initiatives in the veterinary domain (I. Del Seppia, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-initiatives-veterinary-domain-i-del-seppia-ema_en.pdf"},
    {"id":"51235","name":"Presentation - Importance of Data Standards in the European Health Data Space (L. Kustra-Mano, DG SANTE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-importance-data-standards-european-health-data-space-l-kustra-mano-dg-sante_en.pdf"},
    {"id":"51236","name":"Presentation - Overview of the HMA EMA Big Data Taskforce priority 9 and the need for the EMRN Data Standardisation Strategy (J. Kjær, Danish Medicines Agency)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-hma-ema-big-data-taskforce-priority-9-and-need-emrn-data-standardisation-strategy-j-kjaer-danish-medicines-agency_en.pdf"},
    {"id":"51237","name":"Presentation - Session 1: EMRN Data Standardisation Strategy development process and status (N. Halsey, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-emrn-data-standardisation-strategy-development-process-and-status-n-halsey-ema_en.pdf"},
    {"id":"51238","name":"Presentation - Session 1: Potential synergies from existing standards and projects CDISC (D. Evans, CDISC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-potential-synergies-existing-standards-and-projects-cdisc-d-evans-cdisc_en.pdf"},
    {"id":"51239","name":"EU/3/20/2371: Public summary of opinion on orphan designation: Aspacytarabine for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T16:37:00Z","last_updated_date":"2021-05-21T16:37:00Z","reference_number":"EMADOC-628903358-3735","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202371-public-summary-opinion-orphan-designation-aspacytarabine-treatment-acute-myeloid-leukaemia_en.pdf"},
    {"id":"51240","name":"Presentation - Session 1: Potential synergies from existing standards and projects EHDEN OHDSI (P. Rijnbeek, EHDEN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-potential-synergies-existing-standards-and-projects-ehden-ohdsi-p-rijnbeek-ehden_en.pdf"},
    {"id":"51241","name":"Presentation - Session 1: Potential synergies from existing standards and projects HL7 (W. Kubick, HL7 International)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-potential-synergies-existing-standards-and-projects-hl7-w-kubick-hl7-international_en.pdf"},
    {"id":"51242","name":"Presentation - Session 1: Potential synergies from existing standards and projects ISO CEN (C. Hay, GS1)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-potential-synergies-existing-standards-and-projects-iso-cen-c-hay-gs1_en.pdf"},
    {"id":"51243","name":"Presentation - Session 1: Potential synergies from existing standards and projects TEHDAS (E. Bernal Delgado, IACS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-potential-synergies-existing-standards-and-projects-tehdas-e-bernal-delgado-iacs_en.pdf"},
    {"id":"51244","name":"Presentation - Session 1: Stakeholder consultation (preliminary) main highlights (N. Halsey, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-stakeholder-consultation-preliminary-main-highlights-n-halsey-ema_en.pdf"},
    {"id":"51245","name":"Presentation - Session 2: Stakeholder perspective - European Network Data Board (P. Bachman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-stakeholder-perspective-european-network-data-board-p-bachman_en.pdf"},
    {"id":"51246","name":"Presentation - Session 2: Stakeholder perspective and use cases - Patients Consumers (M. Vrana, EHN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-stakeholder-perspective-and-use-cases-patients-consumers-m-vrana-ehn_en.pdf"},
    {"id":"51247","name":"Presentation - Session 2: Stakeholder perspective and use cases - Pharmaceutical industry EFPIA EuropaBio (V. Perkins)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-stakeholder-perspective-and-use-cases-pharmaceutical-industry-efpia-europabio-v-perkins_en.pdf"},
    {"id":"51248","name":"Presentation - Session 2: Stakeholder perspective and use cases - Pharmaceutical industry EUCOPE (T. Case, M. Ericson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-stakeholder-perspective-and-use-cases-pharmaceutical-industry-eucope-t-case-m-ericson_en.pdf"},
    {"id":"51249","name":"Presentation - Session 2: Stakeholder perspective and use cases - Pharmaceutical industry Medicines for Europe (K. Zou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-stakeholder-perspective-and-use-cases-pharmaceutical-industry-medicines-europe-k-zou_en.pdf"},
    {"id":"51250","name":"Presentation - Session 2: Stakeholder perspective and use cases - Researchers (J-W. Boiten)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-21T17:03:00Z","last_updated_date":"2021-05-21T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-stakeholder-perspective-and-use-cases-researchers-j-w-boiten_en.pdf"},
    {"id":"51252","name":"Paromomycin (tissues and eggs of all food producing species): European public MRL assessment report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2021-05-25T11:56:00Z","last_updated_date":"2021-05-25T11:56:00Z","reference_number":"EMA/CVMP/56180/2018","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/paromomycin-tissues-and-eggs-all-food-producing-species-european-public-mrl-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"51256","name":"EU/3/20/2372: Public summary of opinion on orphan designation: Dabrafenib mesylate for the treatment of glioma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-25T15:37:00Z","last_updated_date":"2021-05-25T15:37:00Z","reference_number":"EMADOC-628903358-3737","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202372-public-summary-opinion-orphan-designation-dabrafenib-mesylate-treatment-glioma_en.pdf"},
    {"id":"51257","name":"EU/3/20/2373: Public summary of opinion on orphan designation: Humanised IgG1 monoclonal antibody against the extracellular domain of receptor tyrosine kinase-like orphan receptor 1 coupled via a proteolytically cleavable maleimidocaproyl-valine-citrullin","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-25T16:01:00Z","last_updated_date":"2021-05-25T16:01:00Z","reference_number":"EMADOC-628903358-3738","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202373-public-summary-opinion-orphan-designation-humanised-igg1-monoclonal-antibody-against-extracellular-domain-receptor-tyrosine-kinase-orphan-receptor-1-coupled-proteolytically-cleavable_en.pdf"},
    {"id":"51258","name":"Instructor exercise: How to evaluate an Initial clinical trial application: Assessment and decision CTIS training programme - Module 08","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-05-25T16:15:00Z","last_updated_date":"2021-05-25T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/instructor-exercise-how-evaluate-initial-clinical-trial-application-assessment-and-decision-ctis-training-programme-module-08_en.pptx"},
    {"id":"51261","name":"EU/3/20/2374: Public summary of opinion on orphan designation: Treatment of glioma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-25T16:21:00Z","last_updated_date":"2021-05-25T16:21:00Z","reference_number":"EMADOC-628903358-3739","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202374-public-summary-opinion-orphan-designation-treatment-glioma_en.pdf"},
    {"id":"51264","name":"Minutes of the 111th meeting of the Management Board: 11 March 2021","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2021-05-25T16:50:00Z","last_updated_date":"2021-05-25T16:50:00Z","reference_number":"EMA/MB/153834/2021","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-111th-meeting-management-board-11-march-2021_en.pdf"},
    {"id":"51266","name":"EU/3/20/2375: Public summary of opinion on orphan designation: Treatment of Duchenne muscular dystrophy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-25T16:58:00Z","last_updated_date":"2021-05-25T16:58:00Z","reference_number":"EMADOC-628903358-3727","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202375-public-summary-opinion-orphan-designation-treatment-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"51267","name":"Withdrawal assessment report for Brilique","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2021-05-25T17:21:00Z","last_updated_date":"2021-05-25T17:21:00Z","reference_number":"EMA/459475/2019","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-brilique_en.pdf"},
    {"id":"51271","name":"EU/3/20/2383: Public summary of opinion on orphan designation: Perflubron for the treatment of respiratory distress syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-26T15:57:00Z","last_updated_date":"2021-05-26T15:57:00Z","reference_number":"EMADOC-628903358-3743","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202383-public-summary-opinion-orphan-designation-perflubron-treatment-respiratory-distress-syndrome_en.pdf"},
    {"id":"51272","name":"EU/3/20/2366: Public summary of opinion on orphan designation: Autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B-cell maturation antigen-specific chimeric antigen receptor for the treatment of multiple myeloma","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-26T16:51:00Z","last_updated_date":"2021-05-26T16:51:00Z","reference_number":"EMADOC-628903358-3724","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202366-public-summary-opinion-orphan-designation-autologous-cd4-and-cd8-t-cells-genetically-modified-lentiviral-vector-encoding-b-cell-maturation-antigen-specific-chimeric-antigen-receptor_en.pdf"},
    {"id":"51273","name":"EU/3/20/2384: Public summary of opinion on orphan designation: Sulindac for the treatment of fragile X syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-26T17:22:00Z","last_updated_date":"2021-05-26T17:22:00Z","reference_number":"EMADOC-628903358-3734","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202384-public-summary-opinion-orphan-designation-sulindac-treatment-fragile-x-syndrome_en.pdf"},
    {"id":"51275","name":"EU/3/20/2378: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 9 encoding human ATP7B for the treatment of Wilson’s disease","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T12:42:00Z","last_updated_date":"2021-05-27T12:42:00Z","reference_number":"EMADOC-628903358-3731","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202378-public-summary-opinion-orphan-designation-adeno-associated-viral-vector-serotype-9-encoding-human-atp7b-treatment-wilsons-disease_en.pdf"},
    {"id":"51277","name":"EU/3/20/2379: Public summary of opinion on orphan designation: Synthetic oligonucleotide selectively targeting UBE3A antisense RNA transcripts for the treatment of Angelman syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T14:22:00Z","last_updated_date":"2021-05-27T14:22:00Z","reference_number":"EMADOC-628903358-3740","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202379-public-summary-opinion-orphan-designation-synthetic-oligonucleotide-selectively-targeting-ube3a-antisense-rna-transcripts-treatment-angelman-syndrome_en.pdf"},
    {"id":"51284","name":"EU/3/20/2380: Public summary of opinion on orphan designation: Allogeneic retinal pigment epithelial cells genetically modified with a non-viral vector to express beta-domain deleted human factor VIII for the treatment of haemophilia A","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T14:50:00Z","last_updated_date":"2022-12-05T14:09:00Z","reference_number":"EMADOC-628903358-3741","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202380-public-summary-opinion-orphan-designation-allogeneic-retinal-pigment-epithelial-cells-genetically-modified-non-viral-vector-express-beta-domain-deleted-human-factor-viii-treatment_en.pdf"},
    {"id":"51285","name":"Reply to open letter to ‘Doctors for COVID ethics’ concerning COVID-19 vaccines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T15:22:00Z","last_updated_date":"2021-05-27T15:22:00Z","reference_number":"EMA/292405/2021","document_url":"https://www.ema.europa.eu/en/documents/other/reply-open-letter-doctors-covid-ethics-concerning-covid-19-vaccines_en.pdf"},
    {"id":"51286","name":"EU/3/20/2381: Public summary of opinion on orphan designation: (S)-N-(5-(4-(1-(Benzo[d][1,3]dioxol-5-yl)ethyl)piperazin-1-yl)-1,3,4thiadiazol-2-yl)acetamide, hydrochloride salt for the treatment of progressive supranuclear palsy","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T15:38:00Z","last_updated_date":"2021-05-27T15:38:00Z","reference_number":"EMADOC-628903358-3732","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202381-public-summary-opinion-orphan-designation-s-n-5-4-1-benzod13dioxol-5-ylethylpiperazin-1-yl-134thiadiazol-2-ylacetamide-hydrochloride-salt-treatment-progressive-supranuclear-palsy_en.pdf"},
    {"id":"51287","name":"EU/3/20/2382: Public summary of opinion on orphan designation: Erlotinib for the treatment of Olmsted syndrome","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T16:14:00Z","last_updated_date":"2021-05-27T16:14:00Z","reference_number":"EMADOC-628903358-3742","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202382-public-summary-opinion-orphan-designation-erlotinib-treatment-olmsted-syndrome_en.pdf"},
    {"id":"51290","name":"EU/3/20/2376: Public summary of opinion on orphan designation: 4-[(3S)-3-aminopyrrolidin-1-yl]-6-cyano-5-(3,5-difluorophenyl)-N-[(2S)-1,1,1-trifluoropropan-2-yl]pyridine-3-carboxamide for the treatment of congenital hyperinsulinism","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2021-05-27T17:59:00Z","last_updated_date":"2021-05-27T17:59:00Z","reference_number":"EMADOC-628903358-3729","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu3202376-public-summary-opinion-orphan-designation-4-3s-3-aminopyrrolidin-1-yl-6-cyano-5-35-difluorophenyl-n-2s-111-trifluoropropan-2-ylpyridine-3-carboxamide-treatment-congenital-hyperinsulinism_en.pdf"},
    {"id":"51291","name":"European Medicines Agency's privacy statement for SME status applications submitted by natural persons","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-05-28T12:15:00Z","last_updated_date":"2021-05-28T12:15:00Z","reference_number":"EMA/550671/2020","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-sme-status-applications-submitted-natural-persons_en.pdf"},
    {"id":"51292","name":"From collection to connection – the EMA veterinary data strategy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-05-28T14:25:00Z","last_updated_date":"2021-05-28T14:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/collection-connection-ema-veterinary-data-strategy_en.pdf"},
    {"id":"51293","name":"Report of the joint HMA/EMA workshop on artificial intelligence in medicines regulation","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-05-28T15:26:00Z","last_updated_date":"2021-05-28T15:26:00Z","reference_number":"EMA/292319/2021","document_url":"https://www.ema.europa.eu/en/documents/report/report-joint-hmaema-workshop-artificial-intelligence-medicines-regulation_en.pdf"},
    {"id":"51294","name":"CHMP post-authorisation summary of positive opinion for Comirnaty (II-30)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-05-28T17:14:00Z","last_updated_date":"2021-05-28T17:14:00Z","reference_number":"EMA/303424/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-comirnaty-ii-30_en.pdf"},
    {"id":"51295","name":"Human medicines highlights - May 2021","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-05-31T09:38:00Z","last_updated_date":"2021-05-31T09:38:00Z","reference_number":"Issue 146","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-may-2021_en.pdf"},
    {"id":"51302","name":"Report on the implementation of the EMA-EUnetHTA work plan 2017 - 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-06-01T09:00:00Z","last_updated_date":"2021-06-01T09:00:00Z","reference_number":"EMA/265469/2021","document_url":"https://www.ema.europa.eu/en/documents/report/report-implementation-ema-eunethta-work-plan-2017-2021_en.pdf"},
    {"id":"51303","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - April 2021","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2021-06-01T09:00:00Z","last_updated_date":"2021-06-01T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-april-2021_en.pdf"},
    {"id":"51310","name":"Draft assessment report on Vaccinium macrocarpon Aiton, fructus - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2021-05-31T17:38:00Z","last_updated_date":"2021-05-31T17:38:00Z","reference_number":"EMA/HMPC/517879/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-vaccinium-macrocarpon-aiton-fructus-first-version_en.pdf"},
    {"id":"51313","name":"Draft List of references supporting the assessment of Vaccinium macrocarpon Aiton, fructus - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2021-05-31T17:39:00Z","last_updated_date":"2021-05-31T17:39:00Z","reference_number":"EMA/HMPC/551668/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-vaccinium-macrocarpon-aiton-fructus-first-version_en.pdf"},
    {"id":"51314","name":"Draft Assessment report on Taraxacum officinale F.H. Wigg., radix - First version","type":"herbal-report","status":"Draft","consultation_date":"","first_published_date":"2021-05-31T17:47:00Z","last_updated_date":"2021-05-31T17:47:00Z","reference_number":"EMA/HMPC/475725/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-taraxacum-officinale-fh-wigg-radix-first-version_en.pdf"},
    {"id":"51316","name":"Draft list of references supporting the assessment of Taraxacum officinale F.H. Wigg., radix - First version","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2021-05-31T17:48:00Z","last_updated_date":"2021-05-31T17:48:00Z","reference_number":"EMA/HMPC/475727/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-taraxacum-officinale-fh-wigg-radix-first-version_en.pdf"},
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    {"id":"51320","name":"Veterinary Medicinal Products Regulation highlights - Issue 5","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-05-31T18:12:00Z","last_updated_date":"2021-05-31T18:12:00Z","reference_number":"Issue 5","document_url":"https://www.ema.europa.eu/en/documents/newsletter/veterinary-medicinal-products-regulation-highlights-issue-5_en.pdf"},
    {"id":"51322","name":"HMPC meetings in 2022, 2023 and 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-01T10:21:00Z","last_updated_date":"2021-06-01T10:21:00Z","reference_number":"EMA/HMPC/559729/2020","document_url":"https://www.ema.europa.eu/en/documents/other/hmpc-meetings-2022-2023-and-2024_en.pdf"},
    {"id":"51323","name":"DARWIN EU Advisory Board: Mandate","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-04T10:22:00Z","last_updated_date":"2023-07-27T16:27:00Z","reference_number":"EMA/272563/2023","document_url":"https://www.ema.europa.eu/en/documents/other/darwin-eu-advisory-board-mandate_en.pdf"},
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    {"id":"51330","name":"Programme - Webinar on EMA’s categorisation of antibiotics used in animals","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2021-06-01T16:06:00Z","last_updated_date":"2021-06-01T16:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-webinar-emas-categorisation-antibiotics-used-animals_en.pdf"},
    {"id":"51339","name":"Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-06-02T11:14:00Z","last_updated_date":"2021-06-02T11:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vaxzevriacovid-19-vaccine-astrazeneca-risk-thrombosis-combination-thrombocytopenia-updated-information_en.pdf"},
    {"id":"51349","name":"Direct healthcare professional communication (DHPC): INOmax (nitric oxide) - Difficulties in closing the cylinder valves after use: precautions for use when disconnecting the cylinders from pressure regulators","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-06-03T09:08:00Z","last_updated_date":"2021-06-03T09:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-inomax-nitric-oxide-difficulties-closing-cylinder-valves-after-use-precautions-use-when-disconnecting-cylinders-pressure-regulators_en.pdf"},
    {"id":"51350","name":"Naftifine: List of nationally authorised medicinal products - PSUSA/00002109/202008","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-03T09:24:00Z","last_updated_date":"2021-06-03T09:24:00Z","reference_number":"EMA/127237/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/naftifine-list-nationally-authorised-medicinal-products-psusa00002109202008_en.pdf"},
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    {"id":"51354","name":"Public statement on PegIntron: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2021-06-03T14:50:00Z","last_updated_date":"2021-06-03T14:50:00Z","reference_number":"EMA/282226/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pegintron-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"51356","name":"Reflection paper on forecasting demand for medicinal products in the EU/EEA","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2021-06-03T16:22:00Z","last_updated_date":"2021-06-03T16:22:00Z","reference_number":"EMA/162549/2021","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-forecasting-demand-medicinal-products-eueea_en.pdf"},
    {"id":"51357","name":"2020 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2021-06-14T15:54:00Z","last_updated_date":"2021-06-14T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/2020-annual-report-european-medicines-agency_en.pdf"},
    {"id":"51359","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-06-04T09:29:00Z","last_updated_date":"2021-06-04T09:29:00Z","reference_number":"EMA/195931/2021","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-march-2021_en.pdf"},
    {"id":"51360","name":"Human medicines highlights - June 2021","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-06-04T09:33:00Z","last_updated_date":"2021-06-04T09:33:00Z","reference_number":"Issue 147","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-june-2021_en.pdf"},
    {"id":"51363","name":"Annex 1 -  Field level specification","type":"other","status":"Draft","consultation_date":"","first_published_date":"2021-06-04T14:31:00Z","last_updated_date":"2021-11-23T15:47:00Z","reference_number":"Version 2.7","document_url":"https://www.ema.europa.eu/en/documents/other/annex-1-field-level-specification_en.pdf"},
    {"id":"51364","name":"Annex 2 - EVVET3 Business rules","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-04T14:14:00Z","last_updated_date":"2022-06-01T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-2-evvet3-business-rules_en.xls"},
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    {"id":"51366","name":"EU R2 Dosages to EDQM mapping","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2021-06-04T14:26:00Z","last_updated_date":"2021-06-04T14:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eu-r2-dosages-edqm-mapping_en.xlsx"},
    {"id":"51368","name":"Agenda - ePI information workshop 5 July 2021","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-06-07T16:00:00Z","last_updated_date":"2021-06-28T11:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-epi-information-workshop-5-july-2021_en.pdf"},
    {"id":"51369","name":"Agenda - ePI exploratory workshop on 6, 7 and 8 July","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-06-07T16:00:00Z","last_updated_date":"2021-06-30T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-epi-exploratory-workshop-6-7-and-8-july_en.pdf"},
    {"id":"51370","name":"Agenda - PRAC draft agenda of meeting 7-10 June 2021","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-06-07T14:46:00Z","last_updated_date":"2021-06-07T14:46:00Z","reference_number":"EMA/PRAC/319890/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-draft-agenda-meeting-7-10-june-2021_en.pdf"},
    {"id":"51375","name":"Presentation - EC’s legal proposal for EMA’s reinforced role in crisis preparedness and how it fits with other EC strategic initiatives (A.Rys, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ecs-legal-proposal-emas-reinforced-role-crisis-preparedness-and-how-it-fits-other-ec-strategic-initiatives-arys-ec_en.pdf"},
    {"id":"51376","name":"Presentation - How is EMA preparing for an extended mandate (N.Wathion, Z.Frias, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-ema-preparing-extended-mandate-nwathion-zfrias-ema_en.pdf"},
    {"id":"51377","name":"Presentation - COVID 19 vaccines and therapeutics - An update to the PCWP/HCPWP (M.Cavaleri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-covid-19-vaccines-and-therapeutics-update-pcwphcpwp-mcavaleri-ema_en.pdf"},
    {"id":"51378","name":"Presentation - Monitoring the safety of COVID-19 vaccines using real-world data (C.Cohet, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-safety-covid-19-vaccines-using-real-world-data-ccohet-ema_en.pdf"},
    {"id":"51379","name":"Presentation - COVID-19 vaccines safety surveillance (G.Genov, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-covid-19-vaccines-safety-surveillance-ggenov-ema_en.pdf"},
    {"id":"51380","name":"Presentation - Survey results of patient representatives attending Scientific Advisory Groups or Ad Hoc Expert Meetings (S.Groeneveld, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-results-patient-representatives-attending-scientific-advisory-groups-or-ad-hoc-expert-meetings-sgroeneveld-ema_en.pdf"},
    {"id":"51381","name":"Presentation - Scientific Advisory Groups (SAGs) re-nominations (F.Pignatti, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advisory-groups-sags-re-nominations-fpignatti-ema_en.pdf"},
    {"id":"51382","name":"Presentation - Recent progress on data and analytics and looking to the future (P.Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recent-progress-data-and-analytics-and-looking-future-parlett-ema_en.pdf"},
    {"id":"51383","name":"Presentation - EMA’s Regulatory Science Research Agenda (L.Liu, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-regulatory-science-research-agenda-lliu-ema_en.pdf"},
    {"id":"51384","name":"Presentation - Electronic Product Information (ePI) for EU medicines (E.Scanlan, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-07T15:54:00Z","last_updated_date":"2021-06-07T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronic-product-information-epi-eu-medicines-escanlan-ema_en.pdf"},
    {"id":"51388","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-06-10T10:07:00Z","last_updated_date":"2021-06-10T10:07:00Z","reference_number":"EMA/195931/2021","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-april-2021_en.pdf"},
    {"id":"51390","name":"Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets:  Updated recommendations on tumour lysis syndrome (TLS) in CLL patients","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-06-10T11:15:00Z","last_updated_date":"2021-06-10T11:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-venclyxto-venetoclax-film-coated-tablets-updated-recommendations-tumour-lysis-syndrome-tls-cll-patients_en.pdf"},
    {"id":"51393","name":"Presentation - Veterinary Big Data stakeholder forum - Stakeholder's perspective (J. van de Ven)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-big-data-stakeholder-forum-stakeholders-perspective-j-van-de-ven_en.pdf"},
    {"id":"51394","name":"Presentation - The veterinary profession and big data: a growing partnership (N. De Briyne, FVE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-profession-and-big-data-growing-partnership-n-de-briyne-fve_en.pdf"},
    {"id":"51395","name":"Presentation - Precision livestock farming (J. Lübbo Kleen, CowConsult)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-precision-livestock-farming-j-lubbo-kleen-cowconsult_en.pdf"},
    {"id":"51396","name":"Presentation - Veterinary use of Big Data (E. Strömfelt,  U. Göggerle, AniCura Group)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-use-big-data-e-stromfelt-u-goggerle-anicura-group_en.pdf"},
    {"id":"51397","name":"Presentation - Use of big data in regulatory medicine (E.Tatone, Health Canada)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-big-data-regulatory-medicine-etatone-health-canada_en.pdf"},
    {"id":"51398","name":"Presentation - Community for emerging and zoonotic diseases (A.Osborn, CEZD)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-community-emerging-and-zoonotic-diseases-aosborn-cezd_en.pdf"},
    {"id":"51399","name":"Presentation - Big Data at the FDA Center for Veterinary Medicine (E.Strain, FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-fda-center-veterinary-medicine-estrain-fda_en.pdf"},
    {"id":"51400","name":"Presentation - Data driven surveillance (F.Dórea, SVA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-driven-surveillance-fdorea-sva_en.pdf"},
    {"id":"51401","name":"Presentation - Update on big data activities (P.Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-big-data-activities-parlett-ema_en.pdf"},
    {"id":"51402","name":"Presentation - Big data in antimicrobial use and biosecurity in animal production (J.Dewulf, Ghent University)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-antimicrobial-use-and-biosecurity-animal-production-jdewulf-ghent-university_en.pdf"},
    {"id":"51403","name":"Presentation - The PREMIER project: Managing big data for environmental risk assessment of human pharmaceuticals (A.Ragas, IMI / EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-premier-project-managing-big-data-environmental-risk-assessment-human-pharmaceuticals-aragas-imi-efpia_en.pdf"},
    {"id":"51404","name":"Presentation - Big data and veterinary pharmacovigilance (R.Bhui, Boehringer Ingelheim)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-and-veterinary-pharmacovigilance-rbhui-boehringer-ingelheim_en.pdf"},
    {"id":"51405","name":"Presentation - RWE Examples of Big data & biodevices to support efficacy and effectiveness (C.Stirling, A.Wright, Zoetis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwe-examples-big-data-biodevices-support-efficacy-and-effectiveness-cstirling-awright-zoetis_en.pdf"},
    {"id":"51407","name":"Presentation - Data Science emerging opportunities and challenges for regulatory decision making (C. Cattuto, University of Torino and ISI Foundation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-07-05T01:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-science-emerging-opportunities-and-challenges-regulatory-decision-making-c-cattuto-university-torino-and-isi-foundation_en.pdf"},
    {"id":"51408","name":"Presentation - Next level animal sciences: Big data in the livestock domain (C.Kamphuis, A.Rebel, Wageningen Livestock Research)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-next-level-animal-sciences-big-data-livestock-domain-ckamphuis-arebel-wageningen-livestock-research_en.pdf"},
    {"id":"51409","name":"Presentation - Experiences in implementation of new digital solutions in the regulatory domain (E.Cavalli, EFSA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experiences-implementation-new-digital-solutions-regulatory-domain-ecavalli-efsa_en.pdf"},
    {"id":"51410","name":"Presentation - Proposal for an European Veterinary Big Data Strategy (I.Claassen, T.Heberer, EMA, HMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-european-veterinary-big-data-strategy-iclaassen-theberer-ema-hma_en.pdf"},
    {"id":"51411","name":"Presentation - Veterinary Big Data Stakeholder forum - Association of Veterinary Consultants (K.Hellmann, AVC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-big-data-stakeholder-forum-association-veterinary-consultants-khellmann-avc_en.pdf"},
    {"id":"51412","name":"Presentation - Veterinary Big Data Stakeholder forum - The way ahead for AnimalhealthEurope (R.Clayton)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-big-data-stakeholder-forum-way-ahead-animalhealtheurope-rclayton_en.pdf"},
    {"id":"51413","name":"Presentation - What are FDA CVM ‘s main expectations from Big Data Strategy for the veterinary domain (H.Duggirala, FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-are-fda-cvm-s-main-expectations-big-data-strategy-veterinary-domain-hduggirala-fda_en.pdf"},
    {"id":"51414","name":"Presentation - Veterinary Big Data Stakeholder forum - Federation of Veterinarians of Europe (R. Van Dobbenburgh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-big-data-stakeholder-forum-federation-veterinarians-europe-r-van-dobbenburgh_en.pdf"},
    {"id":"51415","name":"Presentation - The European Veterinary Big Data Strategy: Next steps (R.Carapeto, Spanish Medicines Agency)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T09:17:00Z","last_updated_date":"2021-06-11T09:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-veterinary-big-data-strategy-next-steps-rcarapeto-spanish-medicines-agency_en.pdf"},
    {"id":"51416","name":"Letter of support for Mobilise-D digital mobility outcomes as monitoring biomarkers - Follow-up","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T11:33:00Z","last_updated_date":"2021-06-11T11:33:00Z","reference_number":"EMA/CHMP/SAWP/277641/2021","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-mobilise-d-digital-mobility-outcomes-monitoring-biomarkers-follow_en.pdf"},
    {"id":"51417","name":"Desflurane : List of nationally authorised medicinal products - PSUSA/00000958/202009","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T11:37:00Z","last_updated_date":"2021-06-11T11:37:00Z","reference_number":"EMA/333304/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/desflurane-list-nationally-authorised-medicinal-products-psusa00000958202009_en.pdf"},
    {"id":"51418","name":"Lidocaine : List of nationally authorised medicinal products - PSUSA/00001861/202009","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T11:48:00Z","last_updated_date":"2021-06-11T11:48:00Z","reference_number":"EMA/333431/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-list-nationally-authorised-medicinal-products-psusa00001861202009_en.pdf"},
    {"id":"51419","name":"PRAC statistics: June 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T12:40:00Z","last_updated_date":"2021-06-11T12:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-june-2021_en.pdf"},
    {"id":"51420","name":"Idebenone : List of nationally authorised medicinal products - PSUSA/00001721/202009","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-11T13:27:00Z","last_updated_date":"2021-06-11T13:27:00Z","reference_number":"EMA/333772/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/idebenone-list-nationally-authorised-medicinal-products-psusa00001721202009_en.pdf"},
    {"id":"51424","name":"Deferasirox, dispersible tablets (125 mg, 250 mg and 500 mg), film-coated tablets (90 mg, 180 mg, and 360 mg), and granules (90 mg, 180 mg and 360 mg) product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-06-14T10:41:00Z","last_updated_date":"2021-06-14T10:41:00Z","reference_number":"EMA/CHMP/472383/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/deferasirox-dispersible-tablets-125-mg-250-mg-and-500-mg-film-coated-tablets-90-mg-180-mg-and-360-mg-and-granules-90-mg-180-mg-and-360-mg-product-specific-bioequivalence-guidance_en.pdf-0"},
    {"id":"51428","name":"Annexes - 2020 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2021-06-14T15:55:00Z","last_updated_date":"2021-06-14T15:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annexes-2020-annual-report-european-medicines-agency_en.pdf"},
    {"id":"51429","name":"Annex 10 - 2020 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2021-06-14T15:53:00Z","last_updated_date":"2021-06-14T15:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annex-10-2020-annual-report-european-medicines-agency-chmp-opinions-initial-evaluations-and-extensions-therapeutic-indication_en.xlsx"},
    {"id":"51433","name":"Declaration of interests: Patricia Almeida","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-14T17:45:00Z","last_updated_date":"2021-06-14T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-patricia-almeida_en.pdf"},
    {"id":"51436","name":"Bivalrudin : List of nationally authorised medicinal products - PSUSA/00000421/202009","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-15T10:46:00Z","last_updated_date":"2021-06-15T10:46:00Z","reference_number":"EMA/246488/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/bivalrudin-list-nationally-authorised-medicinal-products-psusa00000421202009_en.pdf"},
    {"id":"51437","name":"Rubidium chloride RB-82 - List of nationally authorised medicinal products - PSUSA-00010806-202010","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-15T11:58:00Z","last_updated_date":"2021-06-15T11:58:00Z","reference_number":"EMA/301053/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/rubidium-chloride-rb-82-list-nationally-authorised-medicinal-products-psusa-00010806-202010_en.pdf"},
    {"id":"51438","name":"European Medicines Agency’s privacy statement for the usability testing of the restricted area of the Union Product Database","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-15T14:24:00Z","last_updated_date":"2021-06-15T14:24:00Z","reference_number":"EMA/309427/2021","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-usability-testing-restricted-area-union-product-database_en.pdf"},
    {"id":"51442","name":"Amlodipine / atorvastatin / perindopril - List of nationally authorised medicinal products - PSUSA/00010431/202010","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-15T17:20:00Z","last_updated_date":"2021-06-15T17:20:00Z","reference_number":"EMA/338907/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-atorvastatin-perindopril-list-nationally-authorised-medicinal-products-psusa00010431202010_en.pdf"},
    {"id":"51443","name":"Report on budgetary and financial management: financial year 2018","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2021-06-15T17:52:00Z","last_updated_date":"2021-06-15T17:52:00Z","reference_number":"EMA/871245/2018","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2018_en.pdf"},
    {"id":"51444","name":"Report on budgetary and financial management: financial year 2019","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2021-06-15T17:52:00Z","last_updated_date":"2021-06-15T17:52:00Z","reference_number":"EMA/231523/2019","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2019_en.pdf"},
    {"id":"51445","name":"Report on budgetary and financial management: financial year 2020","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2021-06-15T17:52:00Z","last_updated_date":"2021-06-15T17:52:00Z","reference_number":"EMA/628814/2020","document_url":"https://www.ema.europa.eu/en/documents/report/report-budgetary-and-financial-management-financial-year-2020_en.pdf"},
    {"id":"51451","name":"Agenda - CAT agenda of the 16-18 June 2021 meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2021-06-16T12:18:00Z","last_updated_date":"2021-06-16T12:18:00Z","reference_number":"EMA/342564/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-18-june-2021-meeting_en.pdf"},
    {"id":"51452","name":"Minoxidil : List of nationally authorised medicines - PSUSA-00002067-202010","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-16T13:26:00Z","last_updated_date":"2021-06-16T13:26:00Z","reference_number":"EMA/343225/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/minoxidil-list-nationally-authorised-medicines-psusa-00002067-202010_en.pdf"},
    {"id":"51460","name":"Agenda for the 112th meeting of the Management Board: 17 June 2021","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-06-16T17:09:00Z","last_updated_date":"2021-06-18T14:00:00Z","reference_number":"EMA/MB/196797/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-112th-meeting-management-board-17-june-2021_en.pdf"},
    {"id":"51480","name":"13C-methacetin : List of nationally authorised medicinal products - PSUSA/00010846/202010","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-06-18T10:01:00Z","last_updated_date":"2021-06-18T10:01:00Z","reference_number":"EMA/346670/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/13c-methacetin-list-nationally-authorised-medicinal-products-psusa00010846202010_en.pdf"},
    {"id":"51490","name":"EudraVigilance access policy for medicines for veterinary use - Revision 2.1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-06-18T16:30:00Z","last_updated_date":"2022-06-01T09:17:00Z","reference_number":"EMA/113700/2008 Rev. 2.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/eudravigilance-access-policy-medicines-veterinary-use-revision-21_en.pdf"},
    {"id":"51493","name":"CVMP summary of positive opinion for Fatrovax RHD","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-06-18T14:23:00Z","last_updated_date":"2021-06-18T14:23:00Z","reference_number":"EMA/CVMP/306191/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-fatrovax-rhd_en.pdf"},
    {"id":"51494","name":"CVMP summary of positive opinion for Tessie","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-06-18T15:01:00Z","last_updated_date":"2021-06-18T15:01:00Z","reference_number":"EMA/CVMP/306774/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-tessie_en.pdf"},
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    {"id":"52034","name":"CHMP post-authorisation summary of positive opinion for Vosevi (X-45-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T19:04:00Z","last_updated_date":"2021-07-23T19:04:00Z","reference_number":"EMA/CHMP/229665/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vosevi-x-45-g_en.pdf"},
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    {"id":"52036","name":"Overview of comments received on the draft guideline on manufacture of the veterinary finished dosage form","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-07-23T16:40:00Z","last_updated_date":"2021-07-23T16:40:00Z","reference_number":"EMA/CVMP/QWP/485008/2019","document_url":"https://www.ema.europa.eu/en/documents/psusa/overview-comments-received-draft-guideline-manufacture-veterinary-finished-dosage-form_en.pdf"},
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    {"id":"52042","name":"Zynteglo Article-20 referral - Changes to the summary of product characteristics, labelling and package leaflet","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2021-07-23T10:40:00Z","last_updated_date":"2021-07-23T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/zynteglo-article-20-referral-changes-summary-product-characteristics-labelling-and-package-leaflet_en.pdf"},
    {"id":"52045","name":"Questions and answers on the outcome of assessment on use of Siklos in the treatment of severe chronic anaemia in sickle cell syndrome","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T11:37:00Z","last_updated_date":"2021-07-23T11:37:00Z","reference_number":"EMA/412082/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-outcome-assessment-use-siklos-treatment-severe-chronic-anaemia-sickle-cell-syndrome_en.pdf"},
    {"id":"52046","name":"CHMP post-authorisation summary of positive opinion for Spikevax (II-21)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T12:01:00Z","last_updated_date":"2021-07-23T12:01:00Z","reference_number":"EMA/CHMP/325680/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-spikevax-ii-21_en.pdf"},
    {"id":"52048","name":"CHMP summary of positive opinion for Nexviadyme","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T12:18:00Z","last_updated_date":"2021-11-12T01:34:00Z","reference_number":"EMA/CHMP/631749/2021 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-nexviadyme_en.pdf"},
    {"id":"52071","name":"Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T17:06:00Z","last_updated_date":"2021-07-23T17:06:00Z","reference_number":"EMA/CVMP/345237/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-safety-and-residue-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-20196_en.pdf"},
    {"id":"52072","name":"Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T17:16:00Z","last_updated_date":"2021-07-23T17:16:00Z","reference_number":"EMA/CVMP/52665/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-efficacy-and-target-animal-safety-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-20196_en.pdf"},
    {"id":"52073","name":"Guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-23T17:24:00Z","last_updated_date":"2021-07-23T17:24:00Z","reference_number":"EMA/CVMP/59531/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-applications-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-20196_en.pdf"},
    {"id":"52074","name":"Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T10:58:00Z","last_updated_date":"2021-07-26T10:58:00Z","reference_number":"EMA/CVMP/EWP/1061/2001 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs-revision-1_en.pdf"},
    {"id":"52075","name":"Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 4","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T11:14:00Z","last_updated_date":"2021-07-26T11:14:00Z","reference_number":"EMA/CVMP/016/2000 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-4_en.pdf"},
    {"id":"52076","name":"Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Rev. 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T11:45:00Z","last_updated_date":"2021-07-26T11:45:00Z","reference_number":"EMA/CVMP/EWP/81976/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-statistical-principles-clinical-trials-veterinary-medicinal-products-pharmaceuticals-rev-1_en.pdf"},
    {"id":"52077","name":"Reflection paper on promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T14:02:00Z","last_updated_date":"2021-07-26T14:02:00Z","reference_number":"EMA/CVMP/143258/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-promoting-authorisation-alternatives-antimicrobial-veterinary-medicinal-products-eu_en.pdf"},
    {"id":"52078","name":"Overview of comments received on 'Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-07-26T14:06:00Z","last_updated_date":"2021-07-26T14:06:00Z","reference_number":"EMA/644209/2020","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-promoting-authorisation-alternatives-antimicrobials-eu_en.pdf"},
    {"id":"52079","name":"Guideline on the demonstration of palatability of veterinary medicinal products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T14:17:00Z","last_updated_date":"2021-07-26T14:17:00Z","reference_number":"EMA/CVMP/EWP/206024/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-demonstration-palatability-veterinary-medicinal-products-revision-1_en.pdf"},
    {"id":"52080","name":"Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T14:43:00Z","last_updated_date":"2021-07-26T14:43:00Z","reference_number":"EMA/CVMP/EWP/459868/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-demonstration-target-animal-safety-and-efficacy-veterinary-medicinal-products-intended-use-farmed-finfish-revision-1_en.pdf"},
    {"id":"52081","name":"Guideline on dossier requirements for anticancer medicinal products for dogs and cats - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T14:51:00Z","last_updated_date":"2021-07-26T14:51:00Z","reference_number":"EMA/CVMP/28510/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-dossier-requirements-anticancer-medicinal-products-dogs-and-cats-revision-1_en.pdf"},
    {"id":"52082","name":"Guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T15:00:00Z","last_updated_date":"2021-07-26T15:00:00Z","reference_number":"EMA/CVMP/EWP/459883/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-veterinary-medicinal-products-controlling-varroa-destructor-parasitosis-bees-revision-1_en.pdf"},
    {"id":"52083","name":"Guidelines on specific efficacy requirements for ectoparasiticides in cattle - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T15:15:00Z","last_updated_date":"2021-07-26T15:15:00Z","reference_number":"EMA/CVMP/625/03-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-specific-efficacy-requirements-ectoparasiticides-cattle-revision-1_en.pdf"},
    {"id":"52084","name":"Guidelines on specific efficacy requirements for ectoparasiticides in sheep - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T15:28:00Z","last_updated_date":"2021-07-26T15:28:00Z","reference_number":"EMA/CVMP/411/01-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-specific-efficacy-requirements-ectoparasiticides-sheep-revision-1_en.pdf"},
    {"id":"52085","name":"Guidelines on specific efficacy requirements for ectoparasiticides in sheep - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T15:28:00Z","last_updated_date":"2021-07-26T15:28:00Z","reference_number":"EMA/CVMP/411/01-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guidelines-specific-efficacy-requirements-ectoparasiticides-sheep-revision-1_en.pdf-0"},
    {"id":"52086","name":"Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 4","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2021-07-26T16:50:00Z","last_updated_date":"2021-07-26T16:50:00Z","reference_number":"EMEA/CVMP/EWP/005/2000 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestation-dogs-and-cats-revision-4_en.pdf"},
    {"id":"52087","name":"Guideline on pharmaceutical fixed combination products - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-26T16:52:00Z","last_updated_date":"2021-07-26T16:52:00Z","reference_number":"EMA/CVMP/83804/2005-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-pharmaceutical-fixed-combination-products-revision-1_en.pdf"},
    {"id":"52096","name":"Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-27T11:08:00Z","last_updated_date":"2021-07-27T11:08:00Z","reference_number":"EMA/CHMP/138502/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf"},
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    {"id":"52194","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-08-04T15:18:00Z","last_updated_date":"2021-08-04T15:18:00Z","reference_number":"EMA/376271/2021","document_url":"https://www.ema.europa.eu/en/documents/report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-june-2021_en.pdf"},
    {"id":"52199","name":"Public statement on Azacitidine Celgene : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2021-08-04T17:49:00Z","last_updated_date":"2021-08-04T17:49:00Z","reference_number":"EMA/305416/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-azacitidine-celgene-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"52217","name":"Public statement on Lumoxiti : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"Adopted","consultation_date":"","first_published_date":"2021-08-11T16:54:00Z","last_updated_date":"2021-08-11T16:54:00Z","reference_number":"EMA/431204/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-lumoxiti-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"52220","name":"Final assessment report on Aloysia citrodora Paláu (syn. Aloysia triphylla (L’Hér.) Kuntze; Verbena triphylla L’Hér.; Lippia citriodora Kunth), folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2021-08-16T10:22:00Z","last_updated_date":"2021-08-16T10:22:00Z","reference_number":"EMA/HMPC/376761/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-aloysia-citrodora-palau-syn-aloysia-triphylla-lher-kuntze-verbena-triphylla-lher-lippia-citriodora-kunth-folium_en.pdf"},
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    {"id":"52222","name":"Final list of references supporting the assessment of Aloysia citrodora Paláu (syn. Aloysia triphylla (L’Hér.) Kuntze; Verbena triphylla L’Hér.; Lippia citriodora Kunth), folium","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2021-08-16T10:40:00Z","last_updated_date":"2021-08-16T10:40:00Z","reference_number":"EMA/HMPC/643161/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-aloysia-citrodora-palau-syn-aloysia-triphylla-lher-kuntze-verbena-triphylla-lher-lippia-citriodora-kunth-folium_en.pdf"},
    {"id":"52223","name":"Final European Union herbal monograph on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2021-08-16T10:42:00Z","last_updated_date":"2021-08-16T10:42:00Z","reference_number":"EMA/HMPC/376770/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-aloysia-citrodora-palau-syn-aloysia-triphylla-lher-kuntze-verbena-triphylla-lher-lippia-citriodora-kunth-folium_en.pdf"},
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    {"id":"52232","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-08-17T15:26:00Z","last_updated_date":"2021-08-17T15:26:00Z","reference_number":"EMA/CAT/358059/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-june-2021_en.pdf"},
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    {"id":"52427","name":"Overview of comments received on 'Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-09-13T13:56:00Z","last_updated_date":"2021-09-13T13:56:00Z","reference_number":"EMA/CHMP/133838/2021","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-palbociclib-hard-capsule-75-mg-100-mg-and-125-mg-and-film-coated-tablet-75-mg-100-mg-and-125-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
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    {"id":"52593","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: September 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-09-23T15:59:00Z","last_updated_date":"2021-09-23T15:59:00Z","reference_number":"EMA/CAT/524986/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-september-2021_en.pdf"},
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    {"id":"52914","name":"Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-10-27T10:39:00Z","last_updated_date":"2021-10-27T10:39:00Z","reference_number":"EMA/610630/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa00001744202103_en.pdf"},
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    {"id":"53046","name":"Withdrawal letter: Flynpovi","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T13:43:00Z","last_updated_date":"2021-11-12T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-flynpovi_en.pdf"},
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    {"id":"53049","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 8-11 November 2021","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/SAWP/586853/2021","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-8-11-november-2021_en.pdf"},
    {"id":"53050","name":"COMP meeting report on the review of applications for orphan designation: November 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-11-10T11:00:00Z","last_updated_date":"2021-11-10T11:00:00Z","reference_number":"EMA/COMP/639056/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-november-2021_en.pdf"},
    {"id":"53056","name":"Human medicines highlights - November 2021","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T10:24:00Z","last_updated_date":"2021-11-11T10:24:00Z","reference_number":"Issue 152","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-november-2021_en.pdf"},
    {"id":"53059","name":"Presentation - CTIS The future user perspective: Welcome (P. Vankeerberghen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T10:34:00Z","last_updated_date":"2021-11-11T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-future-user-perspective-welcome-p-vankeerberghen_en.pdf"},
    {"id":"53060","name":"Presentation - CTR & CTIS: Key Aspects for Users to Consider when Preparing for CTIS (Dr. S. Strasser)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T10:34:00Z","last_updated_date":"2021-11-11T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctr-ctis-key-aspects-users-consider-when-preparing-ctis-dr-s-strasser_en.pdf"},
    {"id":"53062","name":"Presentation - How to prepare for CTIS: a User Perspective (G. Di Matteo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T10:34:00Z","last_updated_date":"2021-11-11T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-prepare-ctis-user-perspective-g-di-matteo_en.pdf"},
    {"id":"53063","name":"Presentation - How to access CTIS training materials and support (F. Westerholm)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T10:34:00Z","last_updated_date":"2021-11-11T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-access-ctis-training-materials-and-support-f-westerholm_en.pdf"},
    {"id":"53064","name":"Presentation - CTIS The future user perspective: Closing (P. Vankeerberghen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T10:34:00Z","last_updated_date":"2021-11-11T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-future-user-perspective-closing-p-vankeerberghen_en.pdf"},
    {"id":"53065","name":"CHMP post-authorisation summary of positive opinion for Noxafil (X-63-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/598957/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-noxafil-x-63-g_en.pdf"},
    {"id":"53067","name":"CHMP summary of opinion for Riltrava Aerosphere","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/627233/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-riltrava-aerosphere_en.pdf"},
    {"id":"53070","name":"Direct healthcare professional communication (DHPC): Forxiga (dapagliflozin) 5mg should no longer be used for the  treatment of Type 1 Diabetes Mellitus","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T13:47:00Z","last_updated_date":"2021-11-11T13:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-forxiga-dapagliflozin-5mg-should-no-longer-be-used-treatment-type-1-diabetes-mellitus_en.pdf"},
    {"id":"53072","name":"CHMP post-authorisation summary of positive opinion for Epclusa (X-56-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/603118/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-epclusa-x-56-g_en.pdf"},
    {"id":"53073","name":"Overview of comments received on Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals (EMA/CHMP/ICH/272147/2021)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T14:16:00Z","last_updated_date":"2021-11-11T14:16:00Z","reference_number":"EMA/628493/2021","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-addendum-ich-guideline-s1b-testing-carcinogenicity-pharmaceuticals-emachmpich2721472021_en.pdf"},
    {"id":"53074","name":"Overview of comments received on ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products (EMA/CHMP/ICH/318372/2021)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-11-11T14:21:00Z","last_updated_date":"2021-11-11T14:21:00Z","reference_number":"EMA/628681/2021","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-guideline-s12-nonclinical-biodistribution-considerations-gene-therapy-products-emachmpich3183722021_en.pdf"},
    {"id":"53076","name":"CHMP post-authorisation summary of positive opinion for Rapiscan (II-38)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T14:52:00Z","last_updated_date":"2021-11-12T14:52:00Z","reference_number":"EMA/CHMP606839/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rapiscan-ii-38_en.pdf"},
    {"id":"53079","name":"CHMP summary of positive opinion for Vyepti","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T15:31:00Z","last_updated_date":"2021-11-12T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vyepti_en.pdf"},
    {"id":"53080","name":"Questions and answers on the withdrawal for the marketing authorisation of Flynpovi (eflornithine / sulindac)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T15:57:00Z","last_updated_date":"2021-11-12T15:57:00Z","reference_number":"EMA/627715/2021","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_cs.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-flynpovi-eflornithine-sulindac_sv.pdf"}},
    {"id":"53082","name":"CHMP post-authorisation summary of positive opinion for Kaftrio (X-08-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/560959/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kaftrio-x-08-g_en.pdf"},
    {"id":"53083","name":"CHMP summary of opinion for Lumykras","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/624008/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-lumykras_en.pdf"},
    {"id":"53086","name":"CHMP summary of positive opinion for Voraxaze","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/505741/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-voraxaze_en.pdf"},
    {"id":"53087","name":"CHMP summary of positive opinion for Wegovy","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T18:21:00Z","last_updated_date":"2021-11-12T18:21:00Z","reference_number":"EMA/CHMP/639299/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-wegovy_en.pdf"},
    {"id":"53088","name":"CHMP post-authorisation summary of opinion for Kalydeco (II-96)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/590546/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-opinion-kalydeco-ii-96_en.pdf"},
    {"id":"53089","name":"CHMP summary of positive opinion for Uplizna","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/625434/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-uplizna_en.pdf"},
    {"id":"53090","name":"CHMP summary of positive opinion for Tavneos","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-11-12T12:00:00Z","last_updated_date":"2021-11-12T12:00:00Z","reference_number":"EMA/CHMP/624375/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tavneos_en.pdf"},
    {"id":"53091","name":"Presentation - Changes in pharmacovigilance, signal detection and surveillance (J.Olaerts, L. Descalzo , EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-changes-pharmacovigilance-signal-detection-and-surveillance-jolaerts-l-descalzo-ema_en.pdf"},
    {"id":"53092","name":"Presentation - Introduction to the UPD (J. Schalansky, A. Vincente, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-upd-j-schalansky-vincente-ema_en.pdf"},
    {"id":"53093","name":"Presentation - Limited markets: what is in for SMEs? (S. Thiele, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-limited-markets-what-smes-s-thiele-ema_en.pdf"},
    {"id":"53094","name":"Presentation - Status update on implementation of Veterinary Medicinal Products Regulation (J. Torren Edo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-status-update-implementation-veterinary-medicinal-products-regulation-j-torren-edo-ema_en.pdf"},
    {"id":"53095","name":"Presentation - Path to marketing authorisation: SMEs’ experiences and peer-to-peer considerations (S. Kennedy, TriviumVet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-path-marketing-authorisation-smes-experiences-and-peer-peer-considerations-s-kennedy-triviumvet_en.pdf"},
    {"id":"53096","name":"Presentation - Path to marketing authorisation SMEs’ experience and considerations (A. Pradera, Equi Cord)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-path-marketing-authorisation-smes-experience-and-considerations-pradera-equi-cord_en.pdf"},
    {"id":"53097","name":"Presentation - Need for MRL evaluation for biological substances (S. Girault, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-need-mrl-evaluation-biological-substances-s-girault-ema_en.pdf"},
    {"id":"53098","name":"Presentation - The role of Novel Therapies Working Party (NTWP) (S. Casado,  Vice-Chair of the NTWP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-novel-therapies-working-party-ntwp-s-casado-vice-chair-ntwp_en.pdf"},
    {"id":"53099","name":"Presentation - Early support to innovation (F. Hasslung Wikström, Chair of the SAWP-V)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-support-innovation-f-hasslung-wikstrom-chair-sawp-v_en.pdf"},
    {"id":"53100","name":"Presentation - Overview of EMA initiatives supporting SMEs (C. Provansal, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:07:00Z","last_updated_date":"2021-11-12T09:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-ema-initiatives-supporting-smes-c-provansal-ema_en.pdf"},
    {"id":"53102","name":"Argatroban : List of nationally authorised medicinal products - PSUSA/00009057/202101","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-11-12T09:34:00Z","last_updated_date":"2021-11-12T09:34:00Z","reference_number":"EMA/656136/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/argatroban-list-nationally-authorised-medicinal-products-psusa00009057202101_en.pdf"},
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    {"id":"53231","name":"Netherlands - trends in the sales of antimicrobial VMPs for food-producing animals between 2010 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/500819/2021","document_url":"https://www.ema.europa.eu/en/documents/report/netherlands-trends-sales-antimicrobial-vmps-food-producing-animals-between-2010-and-2020_en.pdf"},
    {"id":"53232","name":"Norway - trends in the sales of antimicrobial VMPs for food-producing animals between 2010 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/500518/2021","document_url":"https://www.ema.europa.eu/en/documents/report/norway-trends-sales-antimicrobial-vmps-food-producing-animals-between-2010-and-2020_en.pdf"},
    {"id":"53233","name":"Poland - trends in the sales of antimicrobial VMPs for food-producing animals between 2011 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/508279/2021","document_url":"https://www.ema.europa.eu/en/documents/report/poland-trends-sales-antimicrobial-vmps-food-producing-animals-between-2011-and-2020_en.pdf"},
    {"id":"53234","name":"Portugal - trends in the sales of antimicrobial VMPs for food-producing animals between 2010 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/511548/2021","document_url":"https://www.ema.europa.eu/en/documents/report/portugal-trends-sales-antimicrobial-vmps-food-producing-animals-between-2010-and-2020_en.pdf"},
    {"id":"53235","name":"Romania - trends in the sales of antimicrobial VMPs for food-producing animals between 2014 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/501517/2021","document_url":"https://www.ema.europa.eu/en/documents/report/romania-trends-sales-antimicrobial-vmps-food-producing-animals-between-2014-and-2020_en.pdf"},
    {"id":"53236","name":"Sweden - trends in the sales of antimicrobial VMPs for food-producing animals between 2010 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/499230/2021","document_url":"https://www.ema.europa.eu/en/documents/report/sweden-trends-sales-antimicrobial-vmps-food-producing-animals-between-2010-and-2020_en.pdf"},
    {"id":"53237","name":"Slovenia - trends in the sales of antimicrobial VMPs for food-producing animals between 2010 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/507665/2021","document_url":"https://www.ema.europa.eu/en/documents/report/slovenia-trends-sales-antimicrobial-vmps-food-producing-animals-between-2010-and-2020_en.pdf"},
    {"id":"53238","name":"Slovakia - trends in the sales of antimicrobial VMPs for food-producing animals between 2011 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/507685/2021","document_url":"https://www.ema.europa.eu/en/documents/report/slovakia-trends-sales-antimicrobial-vmps-food-producing-animals-between-2011-and-2020_en.pdf"},
    {"id":"53239","name":"United Kingdom - trends in the sales of antimicrobial VMPs for food-producing animals between 2010 and 2020","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T14:00:00Z","last_updated_date":"2021-11-23T14:00:00Z","reference_number":"EMA/530673/2021","document_url":"https://www.ema.europa.eu/en/documents/report/united-kingdom-trends-sales-antimicrobial-vmps-food-producing-animals-between-2010-and-2020_en.pdf"},
    {"id":"53245","name":"EU VICH adverse event report implementation guide","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-11-23T15:41:00Z","last_updated_date":"2021-11-23T15:41:00Z","reference_number":"EMA/186368/202","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/eu-vich-adverse-event-report-implementation-guide_en.pdf"},
    {"id":"53246","name":"VICH schema","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-11-23T15:57:00Z","last_updated_date":"2021-11-23T15:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/vich-schema_en.zip"},
    {"id":"53255","name":"Presentation - Introduction (day 1): Signal management following veterinary good pharmacovigilance practices (J. Olaerts, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-24T12:49:00Z","last_updated_date":"2021-11-24T12:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-day-1-signal-management-following-veterinary-good-pharmacovigilance-practices-j-olaerts-ema_en.pdf"},
    {"id":"53257","name":"Presentation - Analysis (day 1): Signal management following veterinary good pharmacovigilance practices (D. Zondag, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-24T12:51:00Z","last_updated_date":"2021-11-24T12:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-analysis-day-1-signal-management-following-veterinary-good-pharmacovigilance-practices-d-zondag-ema_en.pdf"},
    {"id":"53268","name":"Presentation - Transgene: Stakeholders’ experience with the Clinical Trials Regulation No 536/2014 implementation (Julien Romanetto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T13:51:00Z","last_updated_date":"2021-11-25T13:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-transgene-stakeholders-experience-clinical-trials-regulation-no-5362014-implementation-julien-romanetto_en.pdf"},
    {"id":"53269","name":"Presentation - Access and user management, roles and permissions (A. Rodriguez Sanchez-Beato)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T13:58:00Z","last_updated_date":"2021-11-25T13:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-access-and-user-management-roles-and-permissions-rodriguez-sanchez-beato_en.pdf"},
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    {"id":"53273","name":"Speakers - European Medicines Agency veterinary medicines info day","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T15:23:00Z","last_updated_date":"2021-11-25T15:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/speakers-european-medicines-agency-veterinary-medicines-info-day_en.pdf"},
    {"id":"53274","name":"Presentation - Benefits and challenges of antimicrobial data collection: view from a veterinary practitioner (Giovanbattista Guadagnini,)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T16:06:00Z","last_updated_date":"2021-11-25T16:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-benefits-and-challenges-antimicrobial-data-collection-view-veterinary-practitioner-giovanbattista-guadagnini_en.pdf"},
    {"id":"53275","name":"Presentation - Collecting use data: Denmark as an example - Update on the ASU-project (Laura Mie Jensen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T16:12:00Z","last_updated_date":"2021-11-25T16:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-collecting-use-data-denmark-example-update-asu-project-laura-mie-jensen_en.pdf"},
    {"id":"53276","name":"Presentation - Data collection on sales and use of antimicrobials in France (ANSE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T16:14:00Z","last_updated_date":"2021-11-25T16:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-collection-sales-and-use-antimicrobials-france-anse_en.pdf"},
    {"id":"53277","name":"Public statement on Equidacent : Withdrawal of the marketing authorisation in the European Union","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T16:53:00Z","last_updated_date":"2021-11-25T16:53:00Z","reference_number":"EMA/584437/2021","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/public-statement-equidacent-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"53279","name":"Presentation - Update on approved and candidate COVID-19 vaccines and therapeutics (M. Cavaleri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T17:19:00Z","last_updated_date":"2021-11-25T17:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-approved-and-candidate-covid-19-vaccines-and-therapeutics-m-cavaleri-ema_en.pdf"},
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    {"id":"53281","name":"Presentation - COVID-19 surveillance and vaccination coverage in the EU (P. Kramarz, ECDC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T17:22:00Z","last_updated_date":"2021-11-25T17:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-covid-19-surveillance-and-vaccination-coverage-eu-p-kramarz-ecdc_en.pdf"},
    {"id":"53282","name":"Presentation - Addressing misinformation on COVID-19 vaccines (M. Carr, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-25T17:24:00Z","last_updated_date":"2021-11-25T17:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-addressing-misinformation-covid-19-vaccines-m-carr-ema_en.pdf"},
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    {"id":"53291","name":"Presentation - Introduction to EMA training session (N. Bere, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-11-26T10:59:00Z","last_updated_date":"2021-11-26T10:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-ema-training-session-n-bere-ema_en.pdf"},
    {"id":"53293","name":"Lanthanum : List of nationally authorised medicinal products - PSUSA/00003175/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-11-26T11:54:00Z","last_updated_date":"2021-11-26T11:54:00Z","reference_number":"EMA/703638/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/lanthanum-list-nationally-authorised-medicinal-products-psusa00003175202103_en.pdf"},
    {"id":"53294","name":"Lanthanum : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"53297","name":"Public statement on Pemetrexed Lilly : Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2021-11-26T14:17:00Z","last_updated_date":"2021-11-26T14:17:00Z","reference_number":"EMA/650861/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pemetrexed-lilly-cessation-validity-marketing-authorisation-european-union_en.pdf"},
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    {"id":"53347","name":"Presentation - European collaboration between regulators  and Health Technology Assessment (HTA) bodies (M. Bertgen, EMA), B. Sepodes (CHMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T17:53:00Z","last_updated_date":"2021-12-01T17:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-collaboration-between-regulators-and-health-technology-assessment-hta-bodies-m-bertgen-ema-b-sepodes-chmp_en.pdf"},
    {"id":"53348","name":"Presentation - ICH E8(R1) – General Considerations for Clinical Studies – Finalised (F. Sweeney, EMA), (S. Vamvakas, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T17:54:00Z","last_updated_date":"2021-12-01T17:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-e8r1-general-considerations-clinical-studies-finalised-f-sweeney-ema-s-vamvakas-ema_en.pdf"},
    {"id":"53349","name":"Presentation - CTR, CTIS functionalities and availability of clinical trial data to the public (P. Vankeerberghen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T17:57:00Z","last_updated_date":"2021-12-01T17:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctr-ctis-functionalities-and-availability-clinical-trial-data-public-p-vankeerberghen-ema_en.pdf"},
    {"id":"53350","name":"Presentation - Medicine repurposing pilot project (C. Hernandez, HMA), (C. Bouygues, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T17:58:00Z","last_updated_date":"2021-12-01T17:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicine-repurposing-pilot-project-c-hernandez-hma-c-bouygues-ema_en.pdf"},
    {"id":"53351","name":"Presentation - Civil society members in EMA scientific  committees: an overview (M. Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T18:01:00Z","last_updated_date":"2021-12-01T18:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-civil-society-members-ema-scientific-committees-overview-m-mavris-ema_en.pdf"},
    {"id":"53352","name":"Agenda - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2021-12-02T15:52:00Z","last_updated_date":"2021-12-02T15:52:00Z","reference_number":"EMA/526063/2021 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-16th-industry-stakeholder-platform-operation-european-union-eu-pharmacovigilance_en.pdf"},
    {"id":"53353","name":"Presentation - Monitoring of COVID-19 products: toolkit (Agnieszka Szmigiel, Emil Cochino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-02T17:53:00Z","last_updated_date":"2021-12-02T17:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-covid-19-products-toolkit-agnieszka-szmigiel-emil-cochino_en.pdf"},
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    {"id":"53355","name":"Presentation - Guideline on registry-based studies (Kelly Plüschke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-02T17:59:00Z","last_updated_date":"2021-12-02T17:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guideline-registry-based-studies-kelly-pluschke_en.pdf"},
    {"id":"53356","name":"Presentation - EMA medical literature monitoring service update (Tom Paternoster-Howe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-02T18:02:00Z","last_updated_date":"2021-12-02T18:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-medical-literature-monitoring-service-update-tom-paternoster-howe_en.pdf"},
    {"id":"53357","name":"PRAC statistics: December 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2021-12-03T11:24:00Z","last_updated_date":"2021-12-03T11:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-december-2021_en.pdf"},
    {"id":"53358","name":"Presentation - Periodic safety update report (PSUR): Adherence to PRAC recommendations for national authorized products (NAPs) (Viola Sarinic)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-03T13:35:00Z","last_updated_date":"2021-12-03T13:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-periodic-safety-update-report-psur-adherence-prac-recommendations-national-authorized-products-naps-viola-sarinic_en.pdf"},
    {"id":"53360","name":"Ozenoxacin - List of nationally authorised medicinal products - PSUSA/00010651/202105","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-03T15:00:00Z","last_updated_date":"2021-12-03T15:00:00Z","reference_number":"EMA/689651/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/ozenoxacin-list-nationally-authorised-medicinal-products-psusa00010651202105_en.pdf"},
    {"id":"53361","name":"Oxaliplatin - List of nationally authorised medicinal products - PSUSA/00002229/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-03T15:16:00Z","last_updated_date":"2021-12-03T15:16:00Z","reference_number":"EMA/719030/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxaliplatin-list-nationally-authorised-medicinal-products-psusa00002229202104_en.pdf"},
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    {"id":"53365","name":"Ex ante publicity of a negotiated procedure - EMA/2021/19/LD - Legal advice in relation to Dutch employment and labour law","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2021-12-06T12:00:00Z","last_updated_date":"2021-12-06T12:00:00Z","reference_number":"EMA/589295/2021","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema202119ld-legal-advice-relation-dutch-employment-and-labour-law_en.pdf"},
    {"id":"53367","name":"Highlights - 16th industry stakeholder platform - operation of European Union (EU) pharmacovigilance","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2021-12-06T12:27:00Z","last_updated_date":"2021-12-10T08:43:00Z","reference_number":"EMA/582239/2021 Corr.","document_url":"https://www.ema.europa.eu/en/documents/minutes/highlights-16th-industry-stakeholder-platform-operation-european-union-eu-pharmacovigilance_en.pdf"},
    {"id":"53368","name":"Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary live virtual training course for sponsors - May, June 2022","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T14:25:00Z","last_updated_date":"2022-03-28T15:33:00Z","reference_number":"Courses: #22587; #22588","document_url":"https://www.ema.europa.eu/en/documents/template-form/programme-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-live-virtual-training-course-sponsors-may-june-2022_en.pdf"},
    {"id":"53369","name":"Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training courses - February, May, June 2022","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2021-12-06T14:25:00Z","last_updated_date":"2021-12-06T14:25:00Z","reference_number":"Courses: #22580; #22581; #22582","document_url":"https://www.ema.europa.eu/en/documents/template-form/programme-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-training-courses-february-may-june-2022_en.pdf"},
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    {"id":"53376","name":"Budesonide: List of nationally authorised medicinal products - PSUSA/00000449/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-06T16:55:00Z","last_updated_date":"2021-12-06T16:55:00Z","reference_number":"EMA/695847/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/budesonide-list-nationally-authorised-medicinal-products-psusa00000449202104_en.pdf"},
    {"id":"53377","name":"Human medicines highlights - December 2021","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-12-06T17:00:00Z","last_updated_date":"2021-12-06T17:00:00Z","reference_number":"Issue 153","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-december-2021_en.pdf"},
    {"id":"53378","name":"Direct healthcare professional communication: Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T09:02:00Z","last_updated_date":"2021-12-07T09:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-lymphoseek-tilmanocept-50-micrograms-kit-radiopharmaceutical-preparation-temporary-extension-shelf-life_en.pdf"},
    {"id":"53379","name":"Dexamethasone / netilmicin: List of nationally authorised medicinal products - PSUSA/00010854/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T09:53:00Z","last_updated_date":"2021-12-07T09:53:00Z","reference_number":"EMA/724898/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexamethasone-netilmicin-list-nationally-authorised-medicinal-products-psusa00010854202104_en.pdf"},
    {"id":"53380","name":"Dihydroergotamine: List of nationally authorised medicinal products - PSUSA/00001075/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T10:06:00Z","last_updated_date":"2021-12-07T10:06:00Z","reference_number":"EMA/724961/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/dihydroergotamine-list-nationally-authorised-medicinal-products-psusa00001075202104_en.pdf"},
    {"id":"53382","name":"Withdrawal Assessment Report for Flynpovi","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2021-12-07T11:19:00Z","last_updated_date":"2021-12-07T11:19:00Z","reference_number":"EMA/CHMP/244212/2021 ","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-flynpovi_en.pdf"},
    {"id":"53384","name":"CHMP PROM agenda for the meeting on 15 February 2021","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-12-07T12:02:00Z","last_updated_date":"2021-12-07T12:02:00Z","reference_number":"EMA/CHMP/62546/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-15-february-2021_en.pdf"},
    {"id":"53386","name":"CHMP PROM agenda for the meeting on 15 March 2021","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-12-07T12:30:00Z","last_updated_date":"2021-12-07T12:30:00Z","reference_number":"EMA/CHMP/128280/2021 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-15-march-2021_en.pdf"},
    {"id":"53388","name":"Withdrawal assessment report for Aivlosin","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2021-12-07T11:19:00Z","last_updated_date":"2021-12-07T11:19:00Z","reference_number":"EMA/174508/2021","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-aivlosin_en.pdf"},
    {"id":"53389","name":"Withdrawal letter: Aivlosin","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T13:43:00Z","last_updated_date":"2021-12-07T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aivlosin_en.pdf-0"},
    {"id":"53392","name":"CHMP PROM agenda for the meeting on 12 April 2021","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-12-07T13:58:00Z","last_updated_date":"2021-12-07T13:58:00Z","reference_number":"EMA/CHMP/188718/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-12-april-2021_en.pdf"},
    {"id":"53393","name":"CHMP PROM agenda for the meeting on  10 May 2021","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-12-07T14:18:00Z","last_updated_date":"2021-12-07T14:18:00Z","reference_number":"EMA/CHMP/250952/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-10-may-2021_en.pdf"},
    {"id":"53396","name":"CHMP PROM agenda for the meeting on 14 June 2021","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-12-07T14:39:00Z","last_updated_date":"2021-12-07T14:39:00Z","reference_number":"EMA/CHMP/287712/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-14-june-2021_en.pdf"},
    {"id":"53397","name":"EMA reply to a letter from Members of the European Parliament, Ms M. Rivasi, Mr P. Pedicini and Ms T. Metz concerning COVID-19 vaccines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T16:00:00Z","last_updated_date":"2021-12-07T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-reply-letter-members-european-parliament-ms-m-rivasi-mr-p-pedicini-and-ms-t-metz-concerning-covid-19-vaccines_en.pdf","translations":{"fr":"https://www.ema.europa.eu/fr/documents/other/ema-reply-letter-members-european-parliament-ms-m-rivasi-mr-p-pedicini-and-ms-t-metz-concerning-covid-19-vaccines_fr.pdf"}},
    {"id":"53399","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 22-24 November 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T16:25:00Z","last_updated_date":"2021-12-07T16:25:00Z","reference_number":"EMA/HMPC/708689/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-22-24-november-2021_en.pdf"},
    {"id":"53400","name":"Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2021-12-07T16:37:00Z","last_updated_date":"2021-12-07T16:37:00Z","reference_number":"EMA/622578/2021","document_url":"https://www.ema.europa.eu/en/documents/committee-report/monthly-report-application-procedures-guidelines-and-related-documents-veterinary-medicines-october-2021_en.pdf"},
    {"id":"53402","name":"Agenda - DADI webinar - Introducing DADI: The digital application dataset integration network project to replace electronic application forms","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-12-08T17:24:00Z","last_updated_date":"2021-12-20T11:19:00Z","reference_number":"EMA/729279/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-dadi-webinar-introducing-dadi-digital-application-dataset-integration-network-project-replace-electronic-application-forms_en.pdf"},
    {"id":"53403","name":"Agenda - DADI webinar - Common factors in the fast healthcare interoperability resources (FHIR) data standard for Art.57(2) and eAF","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2021-12-08T09:42:00Z","last_updated_date":"2022-01-25T14:52:00Z","reference_number":"EMA/729278/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-dadi-webinar-common-factors-fast-healthcare-interoperability-resources-fhir-data-standard-art572-and-eaf_en.pdf"},
    {"id":"53404","name":"Agenda - CAT agenda of the 8-10 December 2021 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-12-08T10:31:00Z","last_updated_date":"2021-12-08T10:31:00Z","reference_number":"EMA/CAT/685109/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-8-10-december-2021-meeting_en.pdf"},
    {"id":"53405","name":"Presentation - Updates on the implementation of Veterinary Medicines Regulation (EU) 2019/6 and secondary legislation (Ivo Claassen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:17:00Z","last_updated_date":"2021-12-08T11:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-implementation-veterinary-medicines-regulation-eu-20196-and-secondary-legislation-ivo-claassen_en.pdf"},
    {"id":"53406","name":"Presentation - Veterinary Medicines Regulation (EU) 2019/6 state of play (Eva Zamora)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:21:00Z","last_updated_date":"2021-12-08T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-medicines-regulation-eu-20196-state-play-eva-zamora_en.pdf"},
    {"id":"53407","name":"Presentation - CVMP update on activities relating to the Veterinary Medicines Regulation (EU) 2019/6 (David Murphy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:23:00Z","last_updated_date":"2021-12-08T11:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-update-activities-relating-veterinary-medicines-regulation-eu-20196-david-murphy_en.pdf"},
    {"id":"53408","name":"Presentation - Implementation of the Veterinary Medicines Regulation (EU) 2019/6: Industry preparedness","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:26:00Z","last_updated_date":"2021-12-08T11:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-veterinary-medicines-regulation-eu-20196-industry-preparedness_en.pdf"},
    {"id":"53409","name":"Presentation - Variations for centrally authorised products (Catherine Griffin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:29:00Z","last_updated_date":"2021-12-08T11:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-variations-centrally-authorised-products-catherine-griffin_en.pdf"},
    {"id":"53410","name":"Presentation - Pharmacovigilance, signal detection and surveillance (Jos Olaerts)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:36:00Z","last_updated_date":"2021-12-08T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacovigilance-signal-detection-and-surveillance-jos-olaerts_en.pdf"},
    {"id":"53411","name":"Presentation - Environmental risk assessment for generics (Kristina Paterson, Michael Empl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:40:00Z","last_updated_date":"2021-12-08T11:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-environmental-risk-assessment-generics-kristina-paterson-michael-empl_en.pdf"},
    {"id":"53413","name":"Amlodipine besilate / ramipril, amlodipine / hydrochlorothiazide / ramipril, hydrochlorothiazide / ramipril : List of nationally authorised medicinal products - PSUSA/00010774/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:44:00Z","last_updated_date":"2021-12-08T11:44:00Z","reference_number":"EMA/731539/202121","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-besilate-ramipril-amlodipine-hydrochlorothiazide-ramipril-hydrochlorothiazide-ramipril-list-nationally-authorised-medicinal-products-psusa00010774202103_en.pdf"},
    {"id":"53414","name":"Presentation - Actions for industry until January 2022 and beyond (Jana Schalansky)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:44:00Z","last_updated_date":"2021-12-08T11:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-actions-industry-until-january-2022-and-beyond-jana-schalansky_en.pdf"},
    {"id":"53415","name":"Metformin : List of nationally authorised medicinal products - PSUSA/00002001/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T11:54:00Z","last_updated_date":"2021-12-08T11:54:00Z","reference_number":"EMA/731509/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/metformin-list-nationally-authorised-medicinal-products-psusa00002001202104_en.pdf"},
    {"id":"53417","name":"Overview of comments received on 'Draft guideline on the quality requirements for drug-device combinations - First version'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T12:08:00Z","last_updated_date":"2021-12-08T12:08:00Z","reference_number":"EMA/CHMP/QWP/BWP/725078/2021 ","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf"},
    {"id":"53419","name":"European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2021-12-08T13:53:00Z","last_updated_date":"2021-12-08T13:53:00Z","reference_number":"EMA/HMPC/486551/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/european-union-herbal-monograph-orthosiphon-aristatus-blume-miq-var-aristatus-folium-revision-1_en.pdf"},
    {"id":"53420","name":"Final assessment report on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2021-12-08T13:56:00Z","last_updated_date":"2021-12-08T13:56:00Z","reference_number":"EMA/HMPC/486549/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-orthosiphon-aristatus-blume-miq-var-aristatus-folium-revision-1_en.pdf"},
    {"id":"53421","name":"Final list of references supporting the assessment of Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2021-12-08T14:01:00Z","last_updated_date":"2021-12-08T14:01:00Z","reference_number":"EMA/HMPC/486553/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-orthosiphon-aristatus-blume-miq-var-aristatus-folium-revision-1_en.pdf"},
    {"id":"53422","name":"Overview of comments received on European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T14:07:00Z","last_updated_date":"2021-12-08T14:07:00Z","reference_number":"EMA/HMPC/363594/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-orthosiphon-aristatus-blume-miq-var-aristatus-folium-revision-1_en.pdf"},
    {"id":"53423","name":"N(2)-L-alanyl-L-glutamine : List of nationally authorised medicinal products - PSUSA/00003158/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-08T16:35:00Z","last_updated_date":"2021-12-08T16:35:00Z","reference_number":"EMA/734732/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/n2-l-alanyl-l-glutamine-list-nationally-authorised-medicinal-products-psusa00003158202103_en.pdf"},
    {"id":"53440","name":"CVMP post-authorisation summary of positive opinion for Bravecto (II-0051)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-12-10T15:33:00Z","last_updated_date":"2021-12-10T15:33:00Z","reference_number":"EMA/CVMP/696735/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-bravecto-ii-0051_en.pdf"},
    {"id":"53441","name":"CVMP post-authorisation summary of positive opinion for Improvac (II-0036)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-12-10T15:42:00Z","last_updated_date":"2021-12-10T15:42:00Z","reference_number":"EMA/CVMP/714359/2021 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-improvac-ii-0036_en.pdf"},
    {"id":"53442","name":"Presentation - VGVP module on controls and pharmacovigilance inspections: Introduction and principles (Calogero Cannavo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-10T16:55:00Z","last_updated_date":"2021-12-10T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-vgvp-module-controls-and-pharmacovigilance-inspections-introduction-and-principles-calogero-cannavo_en.pdf"},
    {"id":"53443","name":"Presentation - VGVP module on pharmacovigilance systems, their quality management systems and pharmacovigilance system master files (Sophia Mylona)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-10T17:03:00Z","last_updated_date":"2021-12-10T17:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-vgvp-module-pharmacovigilance-systems-their-quality-management-systems-and-pharmacovigilance-system-master-files-sophia-mylona_en.pdf"},
    {"id":"53449","name":"Clinical Trials Information System (CTIS) highlights - December 2021","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-12-13T15:07:00Z","last_updated_date":"2021-12-13T15:07:00Z","reference_number":"Issue 6","document_url":"https://www.ema.europa.eu/en/documents/newsletter/clinical-trials-information-system-ctis-highlights-december-2021_en.pdf"},
    {"id":"53450","name":"Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2021-12-13T16:00:00Z","last_updated_date":"2021-12-15T13:19:00Z","reference_number":"EMA/743397/2021","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-ich-guideline-m7-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-addendum-step-2b_en.pdf"},
    {"id":"53454","name":"European Medicines Regulatory Network Data Standardisation Strategy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-12-17T17:58:00Z","last_updated_date":"2021-12-17T17:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-regulatory-network-data-standardisation-strategy_en.pdf"},
    {"id":"53456","name":"Agenda - Regulatory science research needs (RSRN) launch event","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2021-12-15T17:00:00Z","last_updated_date":"2022-01-17T14:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-regulatory-science-research-needs-rsrn-launch-event_en.pdf"},
    {"id":"53457","name":"Metamizole : List of nationally authorised medicines - PSUSA/00001997/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-13T17:29:00Z","last_updated_date":"2021-12-13T17:29:00Z","reference_number":"EMA/749047/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-list-nationally-authorised-medicines-psusa00001997202103_en.pdf"},
    {"id":"53458","name":"Metamizole : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001997/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-13T17:31:00Z","last_updated_date":"2021-12-13T17:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/metamizole-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementation-psusa00001997202103_sv.pdf"}},
    {"id":"53462","name":"News bulletin for small and medium-sized enterprises - Issue 54","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:00:00Z","last_updated_date":"2021-12-14T10:00:00Z","reference_number":"Issue 54","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-54_en.pdf"},
    {"id":"53463","name":"Template for the submission of comments for the draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2021-12-16T10:00:00Z","last_updated_date":"2021-12-16T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-submission-comments-draft-guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.docx"},
    {"id":"53465","name":"Deoxycholic acid : List of nationally authorised medicinal products - PSUSA/00010525/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T09:29:00Z","last_updated_date":"2021-12-14T09:29:00Z","reference_number":"EMA/751094/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/deoxycholic-acid-list-nationally-authorised-medicinal-products-psusa00010525202104_en.pdf"},
    {"id":"53467","name":"Presentation - FDA Guidance on real-world data (John Concato)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:16:00Z","last_updated_date":"2021-12-14T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fda-guidance-real-world-data-john-concato_en.pdf"},
    {"id":"53468","name":"Presentation - CHMP guideline on registry-based studies (Kelly Plüschke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:21:00Z","last_updated_date":"2021-12-14T10:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmp-guideline-registry-based-studies-kelly-pluschke_en.pdf"},
    {"id":"53469","name":"Presentation - Breakout session 2: Platform for stakeholders’ consultation (EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:24:00Z","last_updated_date":"2021-12-14T10:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-2-platform-stakeholders-consultation-efpia_en.pdf"},
    {"id":"53470","name":"Presentation - Breakout session 2: Platform for stakeholders’ consultation (Marie-Helene Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:28:00Z","last_updated_date":"2021-12-14T10:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-2-platform-stakeholders-consultation-marie-helene-pinheiro_en.pdf"},
    {"id":"53471","name":"Presentation - Breakout session 3: Process optimisation (Andrej Segec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:31:00Z","last_updated_date":"2021-12-14T10:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-3-process-optimisation-andrej-segec_en.pdf"},
    {"id":"53472","name":"Presentation - Breakout session 4: Training and expertise (Gianmario Candore, Stefania Simou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:34:00Z","last_updated_date":"2021-12-14T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-4-training-and-expertise-gianmario-candore-stefania-simou_en.pdf"},
    {"id":"53473","name":"Presentation - Breakout session 5 - Heterogeneity of results between data sources (Catherine Cohet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:43:00Z","last_updated_date":"2021-12-14T10:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-breakout-session-5-heterogeneity-results-between-data-sources-catherine-cohet_en.pdf"},
    {"id":"53474","name":"Presentation - Lessons learned from the applications submitted to EMA for marketing authorisation and extension of indication, 2018- 2019 (Elisabeth Bakker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:47:00Z","last_updated_date":"2021-12-14T10:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lessons-learned-applications-submitted-ema-marketing-authorisation-and-extension-indication-2018-2019-elisabeth-bakker_en.pdf"},
    {"id":"53475","name":"Presentation - The role of RWE in FDA approvals (J. Rassen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T10:54:00Z","last_updated_date":"2021-12-14T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-rwe-fda-approvals-j-rassen_en.pdf"},
    {"id":"53476","name":"Presentation -  Plenary session 1: Pharmaceutical industry’s experience and challenges with RWE submission in marketing authorisation applications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T11:08:00Z","last_updated_date":"2021-12-14T11:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-plenary-session-1-pharmaceutical-industrys-experience-and-challenges-rwe-submission-marketing-authorisation-applications_en.pdf"},
    {"id":"53477","name":"Pholcodine / biclotymol / chlorphenamine maleate : List of nationally authorised medicinal products - PSUSA/00010437/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T11:25:00Z","last_updated_date":"2021-12-14T11:25:00Z","reference_number":"EMA/751683/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/pholcodine-biclotymol-chlorphenamine-maleate-list-nationally-authorised-medicinal-products-psusa00010437202104_en.pdf"},
    {"id":"53478","name":"Presentation - Plenary session 1: The Charybdis project – Use of real-world data from multiple countries and opportunities for regulatory purpose (Talita Duarte-Salles)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T11:32:00Z","last_updated_date":"2021-12-14T11:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-plenary-session-1-charybdis-project-use-real-world-data-multiple-countries-and-opportunities-regulatory-purpose-talita-duarte-salles_en.pdf"},
    {"id":"53479","name":"Presentation - Introduction to the breakout sessions (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T11:37:00Z","last_updated_date":"2021-12-14T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-breakout-sessions-xavier-kurz_en.pdf"},
    {"id":"53481","name":"Presentation - Plenary session 1: Report from the breakout session 1: Fitness of real-world data for regulatory purpose (Kelly Plueschke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T11:44:00Z","last_updated_date":"2021-12-14T11:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-plenary-session-1-report-breakout-session-1-fitness-real-world-data-regulatory-purpose-kelly-plueschke_en.pdf"},
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    {"id":"53483","name":"Presentation - Plenary session 2: Report from the breakout session 3: Process optimisation (Andrej Segec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T12:03:00Z","last_updated_date":"2021-12-14T12:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-plenary-session-2-report-breakout-session-3-process-optimisation-andrej-segec_en.pdf"},
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    {"id":"53485","name":"Presentation - Plenary session 2:  Report from the breakout session 5: Heterogeneity of results between data sources (Daniel Prieto-Alhambra)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T12:28:00Z","last_updated_date":"2021-12-14T12:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-plenary-session-2-report-breakout-session-5-heterogeneity-results-between-data-sources-daniel-prieto-alhambra_en.pdf"},
    {"id":"53486","name":"Public statement on Docetaxel Teva : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T12:36:00Z","last_updated_date":"2021-12-14T12:36:00Z","reference_number":"EMA/632964/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-docetaxel-teva-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"53489","name":"Presentation - Concluding remarks (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T12:50:00Z","last_updated_date":"2021-12-14T12:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-concluding-remarks-peter-arlett_en.pdf"},
    {"id":"53490","name":"Presentation - Plenary session 3: Analysis and interpretation of realworld data: A 5-year outlook (Patrick Ryan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T13:00:00Z","last_updated_date":"2021-12-14T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-plenary-session-3-analysis-and-interpretation-realworld-data-5-year-outlook-patrick-ryan_en.pdf"},
    {"id":"53491","name":"Withdrawal letter: Zektayos-Hepjuvo","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2021-12-17T13:12:00Z","last_updated_date":"2021-12-17T13:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-zektayos-hepjuvo_en.pdf"},
    {"id":"53493","name":"Final opinion of the HMPC on a European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T13:56:00Z","last_updated_date":"2021-12-14T13:56:00Z","reference_number":"EMA/HMPC/629762/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-orthosiphon-aristatus-blume-miq-var-aristatus-folium-revision-1_en.pdf"},
    {"id":"53497","name":"Public statement on Lextemy : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2021-12-14T14:10:00Z","last_updated_date":"2021-12-14T14:10:00Z","reference_number":"EMA/379539/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-lextemy-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"53533","name":"CHMP summary of positive opinion for Apexxnar","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2021-12-17T17:35:00Z","last_updated_date":"2021-12-17T17:35:00Z","reference_number":"EMA/CHMP/689575/2021","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-apexxnar_en.pdf"},
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    {"id":"53547","name":"Questions and answers on the withdrawal for the marketing authorisation of Zektayos-Hepjuvo (obeticholic acid)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2021-12-17T10:28:00Z","last_updated_date":"2022-04-08T14:25:00Z","reference_number":"EMA/747864/2021","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-zektayos-hepjuvo-obeticholic-acid_sv.pdf"}},
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    {"id":"53553","name":"CHMP post-authorisation summary of positive opinion for Entyvio (II-61)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2021-12-17T14:31:00Z","last_updated_date":"2021-12-17T14:31:00Z","reference_number":"EMA/CHMP/748916/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-entyvio-ii-61_en.pdf"},
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    {"id":"53628","name":"Human anti-d immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001614/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-01-04T10:20:00Z","last_updated_date":"2022-01-04T10:20:00Z","reference_number":"EMA/762845/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-anti-d-immunoglobulin-list-nationally-authorised-medicinal-products-psusa00001614202103_en.pdf"},
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    {"id":"53637","name":"Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/202105","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-01-05T11:47:00Z","last_updated_date":"2022-01-05T11:47:00Z","reference_number":"EMA/772781/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/methoxyflurane-list-nationally-authorised-medicinal-products-psusa00010484202105_en.pdf"},
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    {"id":"53655","name":"Presentation - Second annual EU Big Data Stakeholder Forum 2021: Concluding remarks (P.Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-01-10T12:08:00Z","last_updated_date":"2022-01-10T12:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-second-annual-eu-big-data-stakeholder-forum-2021-concluding-remarks-parlett-ema_en.pdf"},
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    {"id":"53967","name":"Guideline on data requirements for vaccine platform technology master files (vPTMF)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-01-28T15:10:00Z","last_updated_date":"2022-01-28T15:10:00Z","reference_number":"EMA/CVMP/IWP/286631/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-vaccine-platform-technology-master-files-vptmf_en.pdf"},
    {"id":"53968","name":"Overview of comments received on the draft guideline on data requirements for vaccine platform technology master files (vPTMF) (EMA/CVMP/IWP/283631/2021)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T18:38:00Z","last_updated_date":"2022-01-28T18:38:00Z","reference_number":"EMA/CVMP/IWP/618280/2021","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-data-requirements-vaccine-platform-technology-master-files-vptmf-emacvmpiwp2836312021_en.pdf"},
    {"id":"53969","name":"Guideline on data requirements for vaccine antigen master files (VAMF)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-01-28T15:06:00Z","last_updated_date":"2022-01-28T15:06:00Z","reference_number":"EMA/CVMP/IWP/258755/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-requirements-vaccine-antigen-master-files-vamf_en.pdf"},
    {"id":"53970","name":"Overview of comments received on “Guideline on data requirements for vaccine antigen master files (VAMF)” (EMA/CVMP/IWP/258755/2021)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T15:06:00Z","last_updated_date":"2022-01-28T15:06:00Z","reference_number":"EMA/CVMP/IWP/544053/2021","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-data-requirements-vaccine-antigen-master-files-vamf-emacvmpiwp2587552021_en.pdf"},
    {"id":"53973","name":"Questions and answers on the withdrawal for the marketing authorisation of Abylqis (Arachis hypogaea extract)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T19:17:00Z","last_updated_date":"2022-11-23T09:37:00Z","reference_number":"EMA/45097/2022","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-abylqis-arachis-hypogaea-extract_sv.pdf"}},
    {"id":"53974","name":"Withdrawal letter:  Abylqis","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T19:19:00Z","last_updated_date":"2022-01-28T19:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-abylqis_en.pdf"},
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    {"id":"53977","name":"Overview of comments received on 'Draft guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T20:19:00Z","last_updated_date":"2022-01-28T20:19:00Z","reference_number":"EMA/CHMP/QWP/693578/2021 ","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-requirements-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-clinical-trials-revision-2_en.pdf"},
    {"id":"53981","name":"Nasolam Article 29(4) referral - EMA recommends authorisation of Nasolam (midazolam, nasal spray) in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T09:53:00Z","last_updated_date":"2022-04-29T12:42:00Z","reference_number":"EMA/223719/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/nasolam-article-294-referral-ema-recommends-authorisation-nasolam-midazolam-nasal-spray-eu_sv.pdf"}},
    {"id":"53983","name":"Guideline on clinical trials with immunological veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-01-28T10:12:00Z","last_updated_date":"2022-01-28T10:12:00Z","reference_number":"EMA/CVMP/IWP/260956/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-trials-immunological-veterinary-medicinal-products_en.pdf"},
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    {"id":"53986","name":"Synchron Article-31 referral - CHMP list of questions to be addressed by the applicants and marketing authorisation holders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T10:36:00Z","last_updated_date":"2022-01-28T10:36:00Z","reference_number":"EMA/CHMP/25663/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-chmp-list-questions-be-addressed-applicants-and-marketing-authorisation-holders_en.pdf"},
    {"id":"53987","name":"Synchron Article-31 referral - CHMP list of questions to be addressed by Synchron Research Services located in Ahmedabad","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T10:38:00Z","last_updated_date":"2022-01-28T10:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-chmp-list-questions-be-addressed-synchron-research-services-located-ahmedabad_en.pdf"},
    {"id":"53988","name":"Synchron Article-31 referral - Timetable for the procedure - rev 1","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T10:41:00Z","last_updated_date":"2022-07-22T15:21:00Z","reference_number":"EMA/CHMP/25665/2022 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-timetable-procedure-rev-1_en.pdf"},
    {"id":"53989","name":"Synchron Article-31 referral - Notification (Belgium)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T10:43:00Z","last_updated_date":"2022-01-28T10:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-notification-belgium_en.pdf"},
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    {"id":"53994","name":"Synchron Article-31 referral - Notification (Finland)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T11:01:00Z","last_updated_date":"2022-01-28T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-notification-finland_en.pdf"},
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    {"id":"54009","name":"Overview of comments received on the draft guideline on  data requirements for authorisation of immunological  veterinary medicinal products under exceptional circumstances (EMA/CVMP/IWP/251947/2021)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T13:58:00Z","last_updated_date":"2022-01-28T13:58:00Z","reference_number":"EMA/CVMP/IWP/618299/2021 ","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-data-requirements-authorisation-immunological-veterinary-medicinal-products-under-exceptional-circumstances-emacvmpiwp2519472021_en.pdf"},
    {"id":"54014","name":"Work plan for the Committee for Veterinary Medicinal  Products (CVMP) Antimicrobials Working Party (AWP) 2022","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T14:32:00Z","last_updated_date":"2022-01-28T14:32:00Z","reference_number":"EMA/CVMP/AWP/605507/2021 ","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-committee-veterinary-medicinal-products-cvmp-antimicrobials-working-party-awp-2022_en.pdf"},
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    {"id":"54019","name":"Etifoxine-containing medicinal products Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T15:06:00Z","last_updated_date":"2022-01-28T15:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/etifoxine-containing-medicinal-products-article-31-referral-annex-iii_en.pdf"},
    {"id":"54024","name":"Member states' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T16:10:00Z","last_updated_date":"2023-01-26T10:09:00Z","reference_number":"Version 1.2 - August 2022","document_url":"https://www.ema.europa.eu/en/documents/other/member-states-guide-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf"},
    {"id":"54026","name":"Meeting report - Learnings initiative webinar for optimal use of big data for regulatory purpose","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-01-28T16:10:00Z","last_updated_date":"2022-02-03T15:25:00Z","reference_number":"EMA/18271/2022","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-learnings-initiative-webinar-optimal-use-big-data-regulatory-purpose_en.pdf"},
    {"id":"54029","name":"Clinical trials information system - Key information for sponsors on CTIS","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-01-31T09:00:00Z","last_updated_date":"2022-05-17T14:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/clinical-trials-information-system-key-information-sponsors-ctis_en.pdf"},
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    {"id":"54034","name":"Presentation - Measures Taken to help the EU regulatory network to cope with increased workload (F.Day, A.Nolte, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-01-31T10:35:00Z","last_updated_date":"2022-01-31T10:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-measures-taken-help-eu-regulatory-network-cope-increased-workload-fday-anolte-ema_en.pdf"},
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    {"id":"54037","name":"Presentation - Use of master data and IDMP implementation (K.Puusaari, F.Penaranda, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-01-31T10:41:00Z","last_updated_date":"2022-01-31T10:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-master-data-and-idmp-implementation-kpuusaari-fpenaranda-ema_en.pdf"},
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    {"id":"54041","name":"Synchron Article-31 referral - List of medicines concerned by the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-02-01T10:41:00Z","last_updated_date":"2022-09-16T15:33:00Z","reference_number":"EMA/60766/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-list-medicines-concerned-procedure_en.pdf"},
    {"id":"54047","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 7-10 September 2021","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2022-02-02T16:10:00Z","last_updated_date":"2022-02-08T17:12:00Z","reference_number":"EMA/PDCO/526054/2021 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-7-10-september-2021_en.pdf"},
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    {"id":"54051","name":"Member states business processes and roles - CTIS Training Programme - Module 07","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-02-03T11:04:00Z","last_updated_date":"2022-04-04T15:33:00Z","reference_number":"Version n 1.68 – March 2022","document_url":"https://www.ema.europa.eu/en/documents/other/member-states-business-processes-and-roles-ctis-training-programme-module-07_en.pdf"},
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    {"id":"54056","name":"CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-02-03T12:22:00Z","last_updated_date":"2022-02-03T12:22:00Z","reference_number":"EMA/CAT/760977/2021","document_url":"https://www.ema.europa.eu/en/documents/report/cat-monthly-report-application-procedures-guidelines-and-related-documents-advanced-therapies-december-2021_en.pdf"},
    {"id":"54057","name":"Presentation - Introducing DADI: The digital application dataset integration network project to replace electronic application forms","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-02-03T14:03:00Z","last_updated_date":"2022-02-03T14:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introducing-dadi-digital-application-dataset-integration-network-project-replace-electronic-application-forms_en.pdf"},
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    {"id":"54061","name":"Mandatory use of ISO ICSR/ICH E2B(R3) and EDQM terminology for Dosage Forms (DF) and Routes of  Administration (RoA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-02-03T15:18:00Z","last_updated_date":"2022-05-20T11:48:00Z","reference_number":"EMA/580321/2021 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/mandatory-use-iso-icsrich-e2br3-and-edqm-terminology-dosage-forms-df-and-routes-administration-roa_en.pdf"},
    {"id":"54062","name":"EudraVigilance: Obtaining EDQM terms from SPOR","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-02-03T15:20:00Z","last_updated_date":"2022-02-03T15:20:00Z","reference_number":"EMA/580322/2021","document_url":"https://www.ema.europa.eu/en/documents/other/eudravigilance-obtaining-edqm-terms-spor_en.pdf"},
    {"id":"54074","name":"Human medicines highlights - February 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-02-04T13:27:00Z","last_updated_date":"2022-02-04T13:27:00Z","reference_number":"Issue 155","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-february-2022_en.pdf"},
    {"id":"54075","name":"Presentation - Introduction to the regulatory science research needs list (L. Liu and P. Hines, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-02-04T13:37:00Z","last_updated_date":"2022-02-04T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-regulatory-science-research-needs-list-l-liu-and-p-hines-ema_en.pdf"},
    {"id":"54076","name":"Presentation - Academic perspectives on the need for regulatory scientific research (R.H. Guy, University of Bath)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-02-04T13:37:00Z","last_updated_date":"2022-02-04T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-academic-perspectives-need-regulatory-scientific-research-rh-guy-university-bath_en.pdf"},
    {"id":"54077","name":"Presentation - Regulatory science in Horizon Europe and the Innovative Health Initiative (C. Laplaza Santos, DG Research and Innovation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-02-04T13:37:00Z","last_updated_date":"2022-02-04T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-science-horizon-europe-and-innovative-health-initiative-c-laplaza-santos-dg-research-and-innovation_en.pdf"},
    {"id":"54078","name":"Presentation - Opportunities for academia to collaborate on and receive funding for regulatory science research (F.Koenig, M. Posch, Center for Medical Statistics, Informatics and Intelligent Systems","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-02-04T13:37:00Z","last_updated_date":"2022-02-04T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-academia-collaborate-and-receive-funding-regulatory-science-research-fkoenig-m-posch-center-medical-statistics-informatics-and-intelligent-systems_en.pdf"},
    {"id":"54081","name":"Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-02-04T15:57:00Z","last_updated_date":"2023-04-05T14:16:00Z","reference_number":"EMA/151704/2023 (replacing EMA/803916/2022 for the first page disclaimer only) ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-interactive-response-technologies-interactive-voiceweb-response-systems-clinical-trials-particular-emphasis-handling-expiry-dates_en.pdf"},
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    {"id":"54554","name":"European Medicines Agency’s Privacy Statement for the provision of hotel and travel services through the Agency’s online booking tool","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-03-24T15:32:00Z","last_updated_date":"2022-03-24T15:32:00Z","reference_number":"EMA/179740/2022","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-provision-hotel-and-travel-services-through-agencys-online-booking-tool_en.pdf"},
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    {"id":"54598","name":"CTIS newsflash - 25 March 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-03-28T13:36:00Z","last_updated_date":"2022-03-28T13:36:00Z","reference_number":"EMA/183329/2022","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-25-march-2022_en.pdf"},
    {"id":"54599","name":"Highlights from the fifth meeting of the Nitrosamine Implementation Oversight Group (NIOG)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-03-28T14:09:00Z","last_updated_date":"2022-03-28T14:09:00Z","reference_number":"EMA/27908/2022","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-fifth-meeting-nitrosamine-implementation-oversight-group-niog_en.pdf"},
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    {"id":"54607","name":"Amended Biologics Working Party (BWP) Ad hoc Influenza Working Group - EU recommendations for the seasonal influenza vaccine composition for the season 2022/2023","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-03-29T15:05:00Z","last_updated_date":"2022-03-30T12:51:00Z","reference_number":"EMA/CHMP/BWP/116744/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/amended-biologics-working-party-bwp-ad-hoc-influenza-working-group-eu-recommendations-seasonal-influenza-vaccine-composition-season-20222023_en.pdf"},
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    {"id":"54631","name":"Qualification Opinion of Islet Autoantibodies (AAs) as Enrichment Biomarkers for Type 1 Diabetes (T1D) Prevention Clinical Trials","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-03-31T09:58:00Z","last_updated_date":"2022-03-31T09:58:00Z","reference_number":"EMA/CHMP/SAWP/186420/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-islet-autoantibodies-aas-enrichment-biomarkers-type-1-diabetes-t1d-prevention-clinical-trials_en.pdf"},
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    {"id":"54823","name":"CTIS newsflash - 22 April 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-04-25T14:39:00Z","last_updated_date":"2022-04-25T14:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-22-april-2022_en.pdf"},
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    {"id":"54837","name":"Public statement on Pregabalin Mylan Pharma : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-04-26T17:29:00Z","last_updated_date":"2022-04-26T17:29:00Z","reference_number":"EMA/522684/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pregabalin-mylan-pharma-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"54838","name":"Human plasma protease C1 inhibitor : List of nationally authorised medicinal products - PSUSA/00010163/202108","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-04-26T17:36:00Z","last_updated_date":"2022-04-26T17:36:00Z","reference_number":"EMA/237337/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-plasma-protease-c1-inhibitor-list-nationally-authorised-medicinal-products-psusa00010163202108_en.pdf"},
    {"id":"54861","name":"Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2022-04-29T09:31:00Z","last_updated_date":"2022-04-29T09:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-natpar-parathyroid-hormone-100-microgramsdose-powder-and-solvent-solution-injection-expected-shortage-june-30th-2022_en.pdf"},
    {"id":"54862","name":"Executive Steering Group on Shortages and Safety of Medicinal Products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-05-11T10:52:00Z","last_updated_date":"2022-05-11T10:52:00Z","reference_number":"EMA/41493/2022 ","document_url":"https://www.ema.europa.eu/en/documents/other/executive-steering-group-shortages-and-safety-medicinal-products_en.pdf"},
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    {"id":"54874","name":"Agenda - Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-05-02T15:34:00Z","last_updated_date":"2022-05-11T16:24:00Z","reference_number":"EMA/226955/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-digital-application-dataset-integration-dadi-and-product-management-service-pms-webinar-variations-form-human-medicinal-products-what-will-happen-go-live_en.pdf"},
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    {"id":"55063","name":"Questions and answers on the refusal of the marketing authorisation for Ipique (bevacizumab)","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2022-11-12T12:07:00Z","last_updated_date":"2022-11-12T12:07:00Z","reference_number":"EMA/120074/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-ipique-bevacizumab_sv.pdf"}},
    {"id":"55081","name":"Big Data highlights - Issue 2","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-05-24T14:43:00Z","last_updated_date":"2022-05-24T14:43:00Z","reference_number":"Issue 2","document_url":"https://www.ema.europa.eu/en/documents/newsletter/big-data-highlights-issue-2_en.pdf"},
    {"id":"55087","name":"Ex ante publicity of a negotiated procedure: EMA-2022-06-ST - Provision of external meeting and conference facilities","type":"procurement","status":"unknown","consultation_date":"","first_published_date":"2022-05-24T16:44:00Z","last_updated_date":"2022-05-24T16:44:00Z","reference_number":"EMA/317912/2022","document_url":"https://www.ema.europa.eu/en/documents/procurement/ex-ante-publicity-negotiated-procedure-ema-2022-06-st-provision-external-meeting-and-conference-facilities_en.pdf"},
    {"id":"55089","name":"Appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products - Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2022-05-24T17:26:00Z","last_updated_date":"2022-05-24T17:26:00Z","reference_number":"EMA/631612/2021","document_url":"https://www.ema.europa.eu/en/documents/other/appendix-3-guideline-clinical-evaluation-anticancer-medicinal-products-summary-product-characteristics-anticancer-medicinal-product-mock-48_en.pdf"},
    {"id":"55091","name":"Example files - production release version 1.6.4 May 2022 - Veterinary Medicinal Products Regulation: Union Product Database","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-05-24T17:35:00Z","last_updated_date":"2022-05-24T17:35:00Z","reference_number":"Version 1.6.4 - May 2022","document_url":"https://www.ema.europa.eu/en/documents/other/example-files-production-release-version-164-may-2022-veterinary-medicinal-products-regulation-union-product-database_en.zip"},
    {"id":"55092","name":"Clinical Trials Highlights - May 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T08:29:00Z","last_updated_date":"2022-05-25T08:29:00Z","reference_number":"Issue 9","document_url":"https://www.ema.europa.eu/en/documents/newsletter/clinical-trials-highlights-may-2022_en.pdf"},
    {"id":"55095","name":"Agenda - Nitrosamine Implementation Oversight Group (NIOG) - third meeting with pharmaceutical industry","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2022-05-25T14:18:00Z","last_updated_date":"2022-05-25T14:18:00Z","reference_number":"EMA/171422/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-nitrosamine-implementation-oversight-group-niog-third-meeting-pharmaceutical-industry_en.pdf"},
    {"id":"55096","name":"Presentation - Nitrosamine Implementation Oversight Group (NIOG) - third meeting with pharmaceutical industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T14:23:00Z","last_updated_date":"2022-05-25T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nitrosamine-implementation-oversight-group-niog-third-meeting-pharmaceutical-industry_en.pdf"},
    {"id":"55097","name":"Highlights from the third meeting of the Nitrosamine Implementation Oversight Group (NIOG) and pharmaceutical Industry","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T14:16:00Z","last_updated_date":"2022-05-25T14:16:00Z","reference_number":"EMA/171423/2022","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-third-meeting-nitrosamine-implementation-oversight-group-niog-and-pharmaceutical-industry_en.pdf"},
    {"id":"55099","name":"Industry presentation - Nitrosamine Implementation Oversight Group (NIOG) - third meeting with pharmaceutical industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T14:23:00Z","last_updated_date":"2022-05-25T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/industry-presentation-nitrosamine-implementation-oversight-group-niog-third-meeting-pharmaceutical-industry_en.pdf"},
    {"id":"55100","name":"Digital application dataset integration (DADI) human variations form timeline","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T13:11:00Z","last_updated_date":"2022-05-25T13:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/digital-application-dataset-integration-dadi-human-variations-form-timeline_en.pdf"},
    {"id":"55101","name":"Antimicrobial use data reporting per animal categories (numerator) - Manual for reporting the data to EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T13:16:00Z","last_updated_date":"2022-05-25T13:16:00Z","reference_number":"EMA/757638/2021","document_url":"https://www.ema.europa.eu/en/documents/other/antimicrobial-use-data-reporting-animal-categories-numerator-manual-reporting-data-ema_en.pdf"},
    {"id":"55102","name":"Hydroxyethyl starch Article-107i referral - Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients (revised position)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-07-17T14:23:00Z","last_updated_date":"2018-07-17T14:23:00Z","reference_number":"EMA/498908/2018","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_lv.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/hydroxyethyl-starch-article-107i-referral-hydroxyethyl-starch-solutions-cmdh-introduces-new-measures-protect-patients-revised-position_sv.pdf"}},
    {"id":"55103","name":"Minutes - DARWIN EU Advisory Board meeting: 16 February 2022","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T16:37:00Z","last_updated_date":"2022-05-25T16:37:00Z","reference_number":"EMA/191243/2022","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-darwin-eu-advisory-board-meeting-16-february-2022_en.pdf"},
    {"id":"55104","name":"Presentation - Clinical Trials Information System (CTIS) bitesize talk: Modifications","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-05-25T16:45:00Z","last_updated_date":"2022-05-25T16:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-information-system-ctis-bitesize-talk-modifications_en.pdf"},
    {"id":"55106","name":"Role descritpion: Communication officer - FGIV","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-05-30T09:55:00Z","last_updated_date":"2022-05-30T09:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/role-descritpion-communication-officer-fgiv_en.pdf"},
    {"id":"55108","name":"Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2022-05-30T11:44:00Z","last_updated_date":"2022-05-30T11:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-lymphoseek-tilmanocept-50-micrograms-kit-radiopharmaceutical-preparation-temporary-extension-shelf-life_en.pdf"},
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    {"id":"55457","name":"Public statement on Imatinib Actavis : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-07-05T11:47:00Z","last_updated_date":"2022-07-05T11:47:00Z","reference_number":"EMA/578385/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-imatinib-actavis-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"55458","name":"Public statement on Senstend : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-07-05T12:19:00Z","last_updated_date":"2022-07-05T12:19:00Z","reference_number":"EMA/581764/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-senstend-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"55462","name":"Questions and answers on the refusal of a change to the marketing authorisation for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2022-07-05T14:41:00Z","last_updated_date":"2022-07-05T14:41:00Z","reference_number":"EMA/123532/2021","document_url":"https://www.ema.europa.eu/en/documents/smop/questions-and-answers-refusal-change-marketing-authorisation-trelegy-ellipta-fluticasone-furoate-umeclidinium-vilanterol_en.pdf-0"},
    {"id":"55468","name":"Agenda - DADI webinar - Variations form for human medicinal products","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2022-07-06T09:23:00Z","last_updated_date":"2022-07-06T09:23:00Z","reference_number":"EMA/627535/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-dadi-webinar-variations-form-human-medicinal-products_en.pdf"},
    {"id":"55472","name":"Agenda - Understanding the pathophysiology of thrombosis with thrombocytopenia syndrome (TTS) and discussing next steps in research","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-07-06T14:34:00Z","last_updated_date":"2022-07-06T14:34:00Z","reference_number":"EMA/210541/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-understanding-pathophysiology-thrombosis-thrombocytopenia-syndrome-tts-and-discussing-next-steps-research_en.pdf"},
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    {"id":"55504","name":"Nomegestrol and chlormadinone Article-31 referral - Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk of meningioma","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-07-08T12:12:00Z","last_updated_date":"2022-07-08T12:12:00Z","reference_number":"EMA/621250/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/nomegestrol-and-chlormadinone-article-31-referral-medicines-containing-nomegestrol-or-chlormadinone-prac-recommends-new-measures-minimise-risk-meningioma_en.pdf"},
    {"id":"55506","name":"Letter of intent for the submission of a consultation to the European Medicines Agency by a notified body on a companion diagnostic in accordance with Regulation (EU) 2017/746","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2022-07-08T13:56:00Z","last_updated_date":"2023-07-31T14:41:00Z","reference_number":"EMA/781233/2021","document_url":"https://www.ema.europa.eu/en/documents/template-form/letter-intent-submission-consultation-european-medicines-agency-notified-body-companion-diagnostic-accordance-regulation-eu-2017746_en.docx"},
    {"id":"55507","name":"Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (June 2022)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-07-08T14:44:00Z","last_updated_date":"2022-07-08T14:44:00Z","reference_number":"EMA/609895/2022","document_url":"https://www.ema.europa.eu/en/documents/other/agnes-saint-raymond-assessment-outcome-occupational-activities-after-leaving-service-june-2022_en.pdf"},
    {"id":"55510","name":"Presentation - Quarterly system demo - 2022","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-11T12:01:00Z","last_updated_date":"2022-07-11T12:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quarterly-system-demo-2022_en.pdf"},
    {"id":"55512","name":"Public statement on Crixivan : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-07-12T09:14:00Z","last_updated_date":"2022-07-12T09:14:00Z","reference_number":"EMA/636733/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-crixivan-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"55513","name":"Agenda of the CVMP meeting 12-14 July 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-07-12T09:40:00Z","last_updated_date":"2022-07-12T09:40:00Z","reference_number":"EMA/636044/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-12-14-july-2022_en.pdf"},
    {"id":"55515","name":"Agenda - DARWIN EU Advisory Board meeting: 20 April 2022","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-07-12T11:39:00Z","last_updated_date":"2022-07-12T11:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-darwin-eu-advisory-board-meeting-20-april-2022_en.pdf"},
    {"id":"55520","name":"Gadoxetic acid disodium : List of nationally authorised medicinal products - PSUSA/00001509/202108","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-12T14:58:00Z","last_updated_date":"2022-07-12T14:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoxetic-acid-disodium-list-nationally-authorised-medicinal-products-psusa00001509202108_en.pdf"},
    {"id":"55522","name":"Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-07-12T15:16:00Z","last_updated_date":"2022-07-12T15:16:00Z","reference_number":"EMA/49401/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-measurable-residual-disease-clinical-endpoint-multiple-myeloma-studies_en.pdf"},
    {"id":"55525","name":"Carmustine (implant) : List of nationally authorised medicinal products - PSUSA/00010348/202109","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-12T15:58:00Z","last_updated_date":"2022-07-12T15:58:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/carmustine-implant-list-nationally-authorised-medicinal-products-psusa00010348202109_en.pdf"},
    {"id":"55526","name":"Asparaginase, crisantaspase (nationally authorised products) : List of nationally authorised medicinal products - PSUSA/00003161/202108","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-12T17:34:00Z","last_updated_date":"2022-07-12T17:34:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/asparaginase-crisantaspase-nationally-authorised-products-list-nationally-authorised-medicinal-products-psusa00003161202108_en.pdf"},
    {"id":"55527","name":"Bisoprolol / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000420/202111","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-12T17:54:00Z","last_updated_date":"2022-07-13T14:46:00Z","reference_number":"EMA/640852/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/bisoprolol-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00000420202111_en.pdf"},
    {"id":"55528","name":"Ciprofibrate : List of nationally authorised medicinal products - PSUSA/00000771/202112","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-13T08:33:00Z","last_updated_date":"2022-07-13T08:33:00Z","reference_number":"EMA/PRAC/640942/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciprofibrate-list-nationally-authorised-medicinal-products-psusa00000771202112_en.pdf"},
    {"id":"55531","name":"Sodium oxybate (intravenous use) : List of nationally authorised medicinal products - PSUSA/0010613/202110","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-13T12:08:00Z","last_updated_date":"2022-07-13T12:08:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-oxybate-intravenous-use-list-nationally-authorised-medicinal-products-psusa0010613202110_en.pdf"},
    {"id":"55532","name":"Caffeine / ergotamine : List of nationally authorised medicinal products - PSUSA/00000485/202111","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-13T15:51:00Z","last_updated_date":"2022-07-13T15:51:00Z","reference_number":"EMA/642802/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/caffeine-ergotamine-list-nationally-authorised-medicinal-products-psusa00000485202111_en.pdf"},
    {"id":"55533","name":"indapamide / perindopril : List of nationally authorised medicinal products - PSUSA/00010230/202111","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-13T16:38:00Z","last_updated_date":"2022-07-13T16:38:00Z","reference_number":"EMA/643011/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/indapamide-perindopril-list-nationally-authorised-medicinal-products-psusa00010230202111_en.pdf"},
    {"id":"55534","name":"Presentation - Digital application dataset integration (DADI) Q&A webinar - variations form for human medicinal products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-13T17:11:00Z","last_updated_date":"2022-07-13T17:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-digital-application-dataset-integration-dadi-qa-webinar-variations-form-human-medicinal-products_en.pdf"},
    {"id":"55541","name":"Factsheet: Towards better prevention of medicine shortages","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T11:38:00Z","last_updated_date":"2022-07-14T11:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/factsheet-towards-better-prevention-medicine-shortages_en.pdf"},
    {"id":"55542","name":"Info-cards: What can you do when it comes to shortages of medicines?","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T11:59:00Z","last_updated_date":"2022-07-14T11:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/info-cards-what-can-you-do-when-it-comes-shortages-medicines_en.pdf"},
    {"id":"55543","name":"Ketamine : List of nationally authorised medicinal products - PSUSA/00001804/202112","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T14:19:00Z","last_updated_date":"2022-07-14T14:19:00Z","reference_number":"EMA/644666/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/ketamine-list-nationally-authorised-medicinal-products-psusa00001804202112_en.pdf"},
    {"id":"55544","name":"Presentation - Status update in terms of scientific advice capacity and development of proposals moving forward (Iordanis Gravanis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:10:00Z","last_updated_date":"2022-07-14T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-status-update-terms-scientific-advice-capacity-and-development-proposals-moving-forward-iordanis-gravanis_en.pdf"},
    {"id":"55546","name":"Presentation - Repurposing pilot project: Update and first insights (Christelle Bouygues, Anna Tavridou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:20:00Z","last_updated_date":"2022-07-14T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-repurposing-pilot-project-update-and-first-insights-christelle-bouygues-anna-tavridou_en.pdf"},
    {"id":"55547","name":"Presentation - Experience with the ITF framework for 3Rs and new approach methodologies (NAMs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:27:00Z","last_updated_date":"2022-07-14T16:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-itf-framework-3rs-and-new-approach-methodologies-nams_en.pdf"},
    {"id":"55548","name":"Presentation - Report from the focus group on the practical application of principles relevant for the  paediatric investigation plan (PIP) framework (Chrissi Pallidis, Gesine Bejeuhr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:29:00Z","last_updated_date":"2022-07-14T16:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-report-focus-group-practical-application-principles-relevant-paediatric-investigation-plan-pip-framework-chrissi-pallidis-gesine-bejeuhr_en.pdf"},
    {"id":"55549","name":"Presentation - Status of paediatric investigation plan (PIP) compliance check procedure (Peter Karolyi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:31:00Z","last_updated_date":"2022-07-14T16:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-status-paediatric-investigation-plan-pip-compliance-check-procedure-peter-karolyi_en.pdf"},
    {"id":"55550","name":"Presentation - Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making (Nathalie Bere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:33:00Z","last_updated_date":"2022-07-14T16:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-stakeholder-workshop-patient-experience-data-medicines-development-and-regulatory-decision-making-nathalie-bere_en.pdf"},
    {"id":"55551","name":"Presentation - Collaboration at the regulatory/HTA interface Progressing parallel Joint Scientific Consultations: Experience from the first call and preparation of the second one (Antje Behring,Thorsten Olski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:38:00Z","last_updated_date":"2022-07-14T16:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-collaboration-regulatoryhta-interface-progressing-parallel-joint-scientific-consultations-experience-first-call-and-preparation-second-one-antje-behringthorsten-olski_en.pdf"},
    {"id":"55552","name":"Presentation - PRIME: Implementation of recommendations based on first 5 years’ experience with the scheme (Stefanie Prilla)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:40:00Z","last_updated_date":"2022-07-14T16:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prime-implementation-recommendations-based-first-5-years-experience-scheme-stefanie-prilla_en.pdf"},
    {"id":"55553","name":"Presentation - Outcomes of the EMA Survey on Orphan Maintenance Assessment Reports (OMARs) (Kristina Larsson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:47:00Z","last_updated_date":"2022-07-14T16:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outcomes-ema-survey-orphan-maintenance-assessment-reports-omars-kristina-larsson_en.pdf"},
    {"id":"55554","name":"Presentation - Progress with the implementation of the companion diagnostics framework under the EU In-vitro diagnostic Regulation (IVDR) (Ana Trullas, Ciska Verbaanderd)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:51:00Z","last_updated_date":"2022-07-14T16:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-progress-implementation-companion-diagnostics-framework-under-eu-vitro-diagnostic-regulation-ivdr-ana-trullas-ciska-verbaanderd_en.pdf"},
    {"id":"55555","name":"Agenda - Eight industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-07-14T16:56:00Z","last_updated_date":"2022-07-14T16:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eight-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"55557","name":"Good practice guidance for patient and healthcare professional organisations on the prevention of shortages of medicines for human use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-07-15T09:18:00Z","last_updated_date":"2022-07-15T09:18:00Z","reference_number":"EMA/397143/2020","document_url":"https://www.ema.europa.eu/en/documents/other/good-practice-guidance-patient-and-healthcare-professional-organisations-prevention-shortages-medicines-human-use_en.pdf"},
    {"id":"55559","name":"CVMP summary of positive opinion for Lotilaner Elanco","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-07-15T13:46:00Z","last_updated_date":"2022-07-15T13:46:00Z","reference_number":"EMA/CVMP/623416/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-lotilaner-elanco_en.pdf"},
    {"id":"55560","name":"Agenda and registration form - DADI PDF electronic application forms (eAF) training webinar","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-07-15T14:36:00Z","last_updated_date":"2022-07-15T14:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-dadi-pdf-electronic-application-forms-eaf-training-webinar_en.pdf"},
    {"id":"55561","name":"Agenda and registration form - DADI PDF electronic application forms (eAF) training webinar","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-07-15T14:48:00Z","last_updated_date":"2022-07-15T14:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-dadi-pdf-electronic-application-forms-eaf-training-webinar_en.pdf-0"},
    {"id":"55562","name":"Questions and answers - Digital application dataset integration (DADI) and Product Management Service (PMS) webinar - Variations form for human medicinal products - What will happen at go-live","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-07-15T14:52:00Z","last_updated_date":"2022-07-15T14:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-digital-application-dataset-integration-dadi-and-product-management-service-pms-webinar-variations-form-human-medicinal-products-what-will-happen-go-live_en.pdf"},
    {"id":"55563","name":"Agenda of the CHMP meeting 18-21 July 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-07-18T09:31:00Z","last_updated_date":"2022-07-18T09:31:00Z","reference_number":"EMA/CHMP/608233/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-18-21-july-2022_en.pdf"},
    {"id":"55565","name":"Human medicines highlights - July 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-07-18T09:47:00Z","last_updated_date":"2022-07-18T09:47:00Z","reference_number":"Isssue 160","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-july-2022_en.pdf"},
    {"id":"55584","name":"Agenda of the PDCO meeting 19-22 July 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-07-19T10:37:00Z","last_updated_date":"2022-07-19T10:37:00Z","reference_number":"EMA/PDCO/639568/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-meeting-19-22-july-2022_en.pdf"},
    {"id":"55610","name":"COMP meeting report on the review of applications for orphan designation: July 2022","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2022-07-21T11:33:00Z","last_updated_date":"2022-07-21T11:33:00Z","reference_number":"EMA/COMP/646272/2022","document_url":"https://www.ema.europa.eu/en/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-july-2022_en.pdf"},
    {"id":"55612","name":"Withdrawal letter: Parsaclisib Incyte Biosciences Distribution B.V.","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-07-22T13:36:00Z","last_updated_date":"2022-07-22T13:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-parsaclisib-incyte-biosciences-distribution-bv_en.pdf"},
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    {"id":"55806","name":"Record of data processing activity EMA IT Security Operations Centre (SOC)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-08-09T15:23:00Z","last_updated_date":"2022-08-09T15:23:00Z","reference_number":"EMA/684879/2022","document_url":"https://www.ema.europa.eu/en/documents/other/record-data-processing-activity-ema-it-security-operations-centre-soc_en.pdf"},
    {"id":"55809","name":"Dapivirine Vaginal Ring 25 mg - Summary of opinion","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T10:57:00Z","last_updated_date":"2020-07-24T10:57:00Z","reference_number":"EMA/CHMP/330850/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/dapivirine-vaginal-ring-25-mg-summary-opinion_en.pdf"},
    {"id":"55814","name":"Direct healthcare professional communication (DHPC): Visudyne (verteporfin): Information on the continuing supply limitation until end of 2023","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2022-08-12T16:57:00Z","last_updated_date":"2022-08-12T16:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-visudyne-verteporfin-information-continuing-supply-limitation-until-end-2023_en.pdf"},
    {"id":"55815","name":"CHMP PROM agenda for the meeting on 14 March 2022","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2022-08-12T09:23:00Z","last_updated_date":"2022-08-12T09:23:00Z","reference_number":"EMA/CHMP/121881/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-14-march-2022_en.pdf"},
    {"id":"55817","name":"CHMP PROM agenda for the meeting on  11 April 2022","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2022-08-12T09:58:00Z","last_updated_date":"2022-08-12T09:58:00Z","reference_number":"EMA/CHMP/183772/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-11-april-2022_en.pdf"},
    {"id":"55822","name":"CHMP PROM agenda for the meeting on 13 June 2022","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2022-08-12T16:35:00Z","last_updated_date":"2022-08-12T16:35:00Z","reference_number":"EMA/CHMP/288113/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-13-june-2022_en.pdf"},
    {"id":"55824","name":"Agenda of the CHMP written procedure 16-19 August 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-08-16T09:16:00Z","last_updated_date":"2022-08-16T09:16:00Z","reference_number":"EMA/691785/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-written-procedure-16-19-august-2022_en.pdf"},
    {"id":"55825","name":"Public statement on Zynquista: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-08-16T14:42:00Z","last_updated_date":"2022-08-16T14:42:00Z","reference_number":"EMA/275660/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zynquista-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"55826","name":"Presentation - EMA’s Raw Data project (E.Psarelli, M.Rueckbeil, U.Burger, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:28:00Z","last_updated_date":"2022-08-17T14:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-raw-data-project-epsarelli-mrueckbeil-uburger-ema_en.pdf"},
    {"id":"55827","name":"Presentation - Update on the working parties (S.Da Rocha Dias, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:32:00Z","last_updated_date":"2022-08-17T14:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-working-parties-sda-rocha-dias-ema_en.pdf"},
    {"id":"55828","name":"Presentation - QIG (Quality innovation Group) Overview (R.Bream, V.Jekerle, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:34:00Z","last_updated_date":"2022-08-17T14:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qig-quality-innovation-group-overview-rbream-vjekerle-ema_en.pdf"},
    {"id":"55829","name":"Presentation - EMA experience with the MDR implementation (C.Bouygues, P.Venneugues, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:36:00Z","last_updated_date":"2022-08-17T14:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-experience-mdr-implementation-cbouygues-pvenneugues-ema_en.pdf"},
    {"id":"55830","name":"Presentation - Opening our procedures at EMA to Non-EU authorities OPEN Pilot (M.Harvey, F.Day. EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:37:00Z","last_updated_date":"2022-08-17T14:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opening-our-procedures-ema-non-eu-authorities-open-pilot-mharvey-fday-ema_en.pdf"},
    {"id":"55831","name":"Presentation - Updates on IRIS (K.Hamilton, P.Pina Ferreira, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:40:00Z","last_updated_date":"2022-08-17T14:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-iris-khamilton-ppina-ferreira-ema_en.pdf"},
    {"id":"55832","name":"Presentation - RMP publications in EPARs (E.Vatzaki, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:42:00Z","last_updated_date":"2022-08-17T14:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rmp-publications-epars-evatzaki-ema_en.pdf"},
    {"id":"55833","name":"Presentation - Predictability in marketing authorisation submissions","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-08-17T14:53:00Z","last_updated_date":"2022-08-17T14:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-predictability-marketing-authorisation-submissions_en.pdf"},
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    {"id":"55840","name":"Withdrawal letter: Sevsury","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-08-19T16:01:00Z","last_updated_date":"2022-08-19T16:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-sevsury_en.pdf"},
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    {"id":"55842","name":"Questions and answers on the withdrawal for the marketing authorisation of Exkivity (mobocertinib)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2022-08-19T09:37:00Z","last_updated_date":"2022-11-24T12:12:00Z","reference_number":"EMA/665807/2022","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-exkivity-mobocertinib_sv.pdf"}},
    {"id":"55843","name":"Withdrawal letter: Exkivity","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-08-19T09:35:00Z","last_updated_date":"2022-08-19T09:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-exkivity_en.pdf"},
    {"id":"55846","name":"Highlight report from the eighth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-08-19T14:08:00Z","last_updated_date":"2022-08-19T14:08:00Z","reference_number":"EMA/611878/2022","document_url":"https://www.ema.europa.eu/en/documents/report/highlight-report-eighth-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicines_en.pdf"},
    {"id":"55848","name":"Considerations on posology for the use of the vaccine Jynneos/ Imvanex (MVA-BN) against monkeypox","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-08-19T15:32:00Z","last_updated_date":"2022-08-19T15:32:00Z","reference_number":"EMA/700120/2022","document_url":"https://www.ema.europa.eu/en/documents/other/considerations-posology-use-vaccine-jynneos-imvanex-mva-bn-against-monkeypox_en.pdf"},
    {"id":"55850","name":"PRIME eligibility requests: 2023 deadlines for submission and timetable for assessment","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-08-22T09:05:00Z","last_updated_date":"2022-08-22T09:05:00Z","reference_number":"EMA/698619/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/prime-eligibility-requests-2023-deadlines-submission-and-timetable-assessment_en.pdf"},
    {"id":"55853","name":"List of critical medicines for Monkeypox public health emergency (PHE) under Regulation (EU) 2022/123 (obsolete)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-08-22T12:37:00Z","last_updated_date":"2023-05-17T09:14:00Z","reference_number":"EMA/662490/2022","document_url":"https://www.ema.europa.eu/en/documents/other/list-critical-medicines-monkeypox-public-health-emergency-phe-under-regulation-eu-2022123-obsolete_en.pdf"},
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    {"id":"55883","name":"ACT EU multi-annual workplan 2022-2026","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-08-30T12:01:00Z","last_updated_date":"2022-09-02T17:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/act-eu-multi-annual-workplan-2022-2026_en.pdf"},
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    {"id":"55885","name":"Opinion of the HMPC on a European Union herbal monograph on Trigonella foenum-graecum L., semen - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2022-08-30T10:54:00Z","last_updated_date":"2022-08-30T10:54:00Z","reference_number":"EMA/HMPC/755473/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-trigonella-foenum-graecum-l-semen-revision-1_en.pdf"},
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    {"id":"55972","name":"Allergen for therapy: betula verrucosa (sublingual use) : List of nationally authorised medicinal products - PSUSA/00010815/202201","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-05T09:23:00Z","last_updated_date":"2022-09-05T09:23:00Z","reference_number":"EMA/723821/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-therapy-betula-verrucosa-sublingual-use-list-nationally-authorised-medicinal-products-psusa00010815202201_en.pdf"},
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    {"id":"56032","name":"Flunitrazepam : List of nationally authorised medicinal products - PSUSA/00001418/202201","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-08T13:50:00Z","last_updated_date":"2022-09-08T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/flunitrazepam-list-nationally-authorised-medicinal-products-psusa00001418202201_en.pdf"},
    {"id":"56033","name":"P/0325/2021 : EMA decision of 12 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for deucravacitinib (EMEA-002350-PIP03-20)","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T14:14:00Z","last_updated_date":"2022-09-08T14:14:00Z","reference_number":"EMA/382520/2021","document_url":"https://www.ema.europa.eu/en/documents/psusa/p03252021-ema-decision-12-august-2021-agreement-paediatric-investigation-plan-and-granting-deferral-and-granting-waiver-deucravacitinib-emea-002350-pip03-20_en.pdf"},
    {"id":"56034","name":"Citalopram : List of nationally authorised medicinal products - PSUSA/00000779/202112","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-08T14:15:00Z","last_updated_date":"2022-09-08T14:15:00Z","reference_number":"EMA/757582/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/citalopram-list-nationally-authorised-medicinal-products-psusa00000779202112_en.pdf"},
    {"id":"56048","name":"Flumazenil : List of nationally authorised medicinal products - PSUSA/00001413/202112","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-09T09:02:00Z","last_updated_date":"2022-09-09T09:02:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/flumazenil-list-nationally-authorised-medicinal-products-psusa00001413202112_en.pdf"},
    {"id":"56049","name":"Pilocarpine (ophthalmic formulation) : List of nationally authorised medicinal products - PSUSA/00002410/202108","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-09T13:15:00Z","last_updated_date":"2022-09-09T13:15:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/pilocarpine-ophthalmic-formulation-list-nationally-authorised-medicinal-products-psusa00002410202108_en.pdf"},
    {"id":"56051","name":"Praziquantel (all ruminants except bovine, Equidae, fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits","type":"mrl-summary","status":"Adopted","consultation_date":"","first_published_date":"2022-09-09T16:00:00Z","last_updated_date":"2022-09-09T16:00:00Z","reference_number":"EMA/CVMP/706481/2022","document_url":"https://www.ema.europa.eu/en/documents/mrl-summary/praziquantel-all-ruminants-except-bovine-equidae-fin-fish-summary-opinion-cvmp-establishment-maximum-residue-limits_en.pdf"},
    {"id":"56052","name":"CVMP post-authorisation summary of positive opinion for Improvac (VRA-0039-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-09T16:55:00Z","last_updated_date":"2022-09-09T16:55:00Z","reference_number":"EMA/CVMP/721187/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-improvac-vra-0039-g_en.pdf"},
    {"id":"56054","name":"Methohexital : List of nationally authorised medicinal products - PSUSA/00010656/202201","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-09T16:24:00Z","last_updated_date":"2022-09-09T16:24:00Z","reference_number":"EMA/734182/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/methohexital-list-nationally-authorised-medicinal-products-psusa00010656202201_en.pdf"},
    {"id":"56055","name":"Presentation - Union Product Database: webinar on variations not requiring assessment (VNRAs) for marketing authorisation holders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-09T16:39:00Z","last_updated_date":"2022-09-09T16:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-union-product-database-webinar-variations-not-requiring-assessment-vnras-marketing-authorisation-holders_en.pdf"},
    {"id":"56056","name":"Esketamine (except for centrally authorised products) : list of nationally authorised medicinal products - PSUSA/00001266/202108","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-09T16:42:00Z","last_updated_date":"2022-09-09T16:42:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/esketamine-except-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00001266202108_en.pdf"},
    {"id":"56057","name":"Direct healthcare professional communication (DHPC): Nulojix (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:57:00Z","last_updated_date":"2022-09-12T16:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-nulojix-belatacept-risk-medication-errors-due-change-maintenance-dose-5-mgkg-6-mgkg_en.pdf"},
    {"id":"56059","name":"Agenda of the CHMP meeting 12-15 September 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-09-12T10:33:00Z","last_updated_date":"2022-09-12T10:33:00Z","reference_number":"EMA/CHMP/700565/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-12-15-september-2022_en.pdf"},
    {"id":"56068","name":"Minutes - Highlight report from the 8th Industry stakeholder platform on research and development support","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2022-09-13T09:46:00Z","last_updated_date":"2022-09-13T09:46:00Z","reference_number":"EMA/644334/2021","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-highlight-report-8th-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"56072","name":"Example files - production release version 1.6.8 September 2022 - Veterinary Medicinal Products Regulation: Union Product Database","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:08:00Z","last_updated_date":"2022-09-12T16:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/example-files-production-release-version-168-september-2022-veterinary-medicinal-products-regulation-union-product-database_en.zip"},
    {"id":"56074","name":"Appendix - European Union list of fragrance allergens requiring labelling on cosmetic and detergent products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:29:00Z","last_updated_date":"2022-09-12T16:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_bg.pdf","es":"https://www.ema.europa.eu/es/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_cs.pdf","da":"https://www.ema.europa.eu/da/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_da.pdf","de":"https://www.ema.europa.eu/de/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_de.pdf","et":"https://www.ema.europa.eu/et/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_et.pdf","el":"https://www.ema.europa.eu/el/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_hr.pdf","it":"https://www.ema.europa.eu/it/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_sv.pdf","is":"https://www.ema.europa.eu/is/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_is.pdf","no":"https://www.ema.europa.eu/no/documents/other/appendix-european-union-list-fragrance-allergens-requiring-labelling-cosmetic-and-detergent-products_no.pdf"}},
    {"id":"56075","name":"Presentation - Session 1.a: Key functionalities to protect personal data and CCI in CTIS (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1a-key-functionalities-protect-personal-data-and-cci-ctis-ema_en.pdf"},
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    {"id":"56078","name":"Presentation - Session 1.c: Protection of personal data and CCI for documents uploaded to CTIS (R.Pankow, ACRO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1c-protection-personal-data-and-cci-documents-uploaded-ctis-rpankow-acro_en.pdf"},
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    {"id":"56081","name":"Presentation - Session 1.e: Use of deferrals in CTIS, feedback from Member States (A.M. Janson Lang, Swedish MPA; S. Strasser, Austrian MPA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1e-use-deferrals-ctis-feedback-member-states-am-janson-lang-swedish-mpa-s-strasser-austrian-mpa_en.pdf"},
    {"id":"56082","name":"Presentation - Session 2.b: Protection of Personal Data and CCI for documents uploaded and published via CTIS (EuropaBio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2b-protection-personal-data-and-cci-documents-uploaded-and-published-ctis-europabio_en.pdf"},
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    {"id":"56085","name":"Presentation - Session 3.a: Main principles for commercially confidential information (CCI) in the Clinical Trial Information System (CTIS) (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3a-main-principles-commercially-confidential-information-cci-clinical-trial-information-system-ctis-ema_en.pdf"},
    {"id":"56086","name":"Presentation - Session 3.b: Protection of Personal Data and CCI for documents uploaded and published via CTIS (EuropaBio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3b-protection-personal-data-and-cci-documents-uploaded-and-published-ctis-europabio_en.pdf"},
    {"id":"56087","name":"Event summary - Workshop on the guidance on the protection of personal data and commercially confidential information (CCI) in documents submitted or uploaded via CTIS","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2022-09-12T16:53:00Z","last_updated_date":"2022-09-12T16:53:00Z","reference_number":"EMA/652218/2022","document_url":"https://www.ema.europa.eu/en/documents/minutes/event-summary-workshop-guidance-protection-personal-data-and-commercially-confidential-information-cci-documents-submitted-or-uploaded-ctis_en.pdf"},
    {"id":"56093","name":"Agenda - Fifth EMA-Medicines for Europe bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-09-13T14:03:00Z","last_updated_date":"2022-09-13T14:03:00Z","reference_number":"EMA/661919/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fifth-ema-medicines-europe-bilateral-meeting_en.pdf"},
    {"id":"56096","name":"CHMP summary of opinion for Livtencity","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T12:00:00Z","last_updated_date":"2022-09-16T12:00:00Z","reference_number":"EMA/CHMP/248091/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-livtencity_en.pdf"},
    {"id":"56097","name":"CHMP post-authorisation summary of opinion for Exparel liposomal","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T02:00:00Z","last_updated_date":"2022-09-16T02:00:00Z","reference_number":"EMA/CHMP/762558/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-opinion-exparel-liposomal_en.pdf"},
    {"id":"56100","name":"CHMP post-authorisation summary of positive opinion for Adtralza (II-0002)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T10:38:00Z","last_updated_date":"2022-09-16T10:38:00Z","reference_number":"EMA/CHMP/742227/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adtralza-ii-0002_en.pdf"},
    {"id":"56101","name":"CHMP summary of positive opinion for Teriflunomide Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T10:45:00Z","last_updated_date":"2022-09-16T10:45:00Z","reference_number":"EMA/CHMP/748820/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-teriflunomide-accord_en.pdf"},
    {"id":"56102","name":"CHMP summary of positive opinion for Enjaymo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T11:17:00Z","last_updated_date":"2022-09-16T11:17:00Z","reference_number":"EMA/CHMP/723511/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-enjaymo_en.pdf"},
    {"id":"56103","name":"CHMP summary of positive opinion for Pyrukynd","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T12:00:00Z","last_updated_date":"2022-09-16T12:00:00Z","reference_number":"EMA/CHMP/734156/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pyrukynd_en.pdf"},
    {"id":"56104","name":"CHMP summary of positive opinion for Zynlonta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T13:07:00Z","last_updated_date":"2022-09-19T11:54:00Z","reference_number":"EMA/CHMP/722012/2022 Corr.","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zynlonta_en.pdf"},
    {"id":"56105","name":"CHMP summary of positive opinion for Teriparatide Sun","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T13:34:00Z","last_updated_date":"2022-09-16T13:34:00Z","reference_number":"EMA/CHMP/734147/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-teriparatide-sun_en.pdf"},
    {"id":"56106","name":"CHMP post-authorisation summary of positive opinion for Vaxneuvance (II-01)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T13:40:00Z","last_updated_date":"2022-09-16T13:40:00Z","reference_number":"EMA/CHMP/762289/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-vaxneuvance-ii-01_en.pdf"},
    {"id":"56107","name":"CHMP post-authorisation summary of positive opinion for Yescarta (II-46)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T13:44:00Z","last_updated_date":"2022-09-16T13:44:00Z","reference_number":"EMA/CHMP/760015/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yescarta-ii-46_en.pdf"},
    {"id":"56108","name":"CHMP post-authorisation summary of positive opinion for Skyrizi (X-20-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T13:49:00Z","last_updated_date":"2022-09-16T13:49:00Z","reference_number":"EMA/CHMP/727463/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-skyrizi-x-20-g_en.pdf"},
    {"id":"56109","name":"CHMP summary of positive opinion for Ximluci","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T13:56:00Z","last_updated_date":"2022-09-16T13:56:00Z","reference_number":"EMA/CHMP/733467/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ximluci_en.pdf"},
    {"id":"56110","name":"CHMP post-authorisation summary of positive opinion for Biktarvy (X-40-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T14:26:00Z","last_updated_date":"2022-09-16T14:26:00Z","reference_number":"EMA/CHMP/765087/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-biktarvy-x-40-g_en.pdf"},
    {"id":"56111","name":"CHMP summary of positive opinion for Melatonin Neurim","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T12:00:00Z","last_updated_date":"2022-09-16T12:00:00Z","reference_number":"EMA/CHMP/734993/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-melatonin-neurim_en.pdf"},
    {"id":"56112","name":"CHMP post-authorisation summary of positive opinion for Revolade (II-68)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T16:13:00Z","last_updated_date":"2022-09-16T16:13:00Z","reference_number":"EMA/CHMP/721208/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-revolade-ii-68_en.pdf"},
    {"id":"56113","name":"CHMP summary of positive opinion for Beyfortus","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T16:26:00Z","last_updated_date":"2022-09-16T16:26:00Z","reference_number":"EMA/CHMP/647784/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-beyfortus_en.pdf"},
    {"id":"56115","name":"CHMP post-authorisation summary of positive opinion for Veklury (II-35-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T17:03:00Z","last_updated_date":"2022-09-16T17:03:00Z","reference_number":"EMA/CHMP/722554/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-veklury-ii-35-g_en.pdf"},
    {"id":"56116","name":"CHMP post-authorisation summary of positive opinion for Xalkori (II-0072)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T09:03:00Z","last_updated_date":"2022-09-16T09:03:00Z","reference_number":"EMA/CHMP/757723/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xalkori-ii-0072_en.pdf"},
    {"id":"56119","name":"Agenda - Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-09-16T09:26:00Z","last_updated_date":"2022-10-28T14:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-clinical-trials-information-system-ctis-webinar-9-months-and-going-forward_en.pdf"},
    {"id":"56124","name":"Decision of the Management Board on amending budget No. 01, amending appropriations in budget 2022","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T09:59:00Z","last_updated_date":"2022-09-16T09:59:00Z","reference_number":"EMA/93616/2022","document_url":"https://www.ema.europa.eu/en/documents/other/decision-management-board-amending-budget-no-01-amending-appropriations-budget-2022_en.pdf"},
    {"id":"56126","name":"CHMP summary of positive opinion for Sorafenib Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T11:39:00Z","last_updated_date":"2022-09-16T11:39:00Z","reference_number":"EMA/CHMP/758392/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sorafenib-accord_en.pdf"},
    {"id":"56127","name":"CHMP post-authorisation summary of positive opinion for Brukinsa (II-02)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T11:49:00Z","last_updated_date":"2022-09-16T11:49:00Z","reference_number":"EMA/CHMP/767634/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-brukinsa-ii-02_en.pdf"},
    {"id":"56128","name":"Synchron Article-31 referral - Re-examination confirms suspension of medicines over flawed studies","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-09-16T12:17:00Z","last_updated_date":"2022-12-16T14:12:00Z","reference_number":"EMA/915838/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/synchron-article-31-referral-re-examination-confirms-suspension-medicines-over-flawed-studies_sv.pdf"}},
    {"id":"56129","name":"CHMP summary of positive opinion for Teriflunomide Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-09-16T15:36:00Z","last_updated_date":"2022-09-16T15:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-teriflunomide-mylan_en.pdf"},
    {"id":"56139","name":"Overview of comments received for Prognostic Covariate Adjustment (PROCOVA™) with responses","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-09-20T14:19:00Z","last_updated_date":"2022-09-20T14:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-prognostic-covariate-adjustment-procovatm-responses_en.pdf"},
    {"id":"56140","name":"Qualification opinion for Prognostic Covariate Adjustment (PROCOVA™)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-09-20T14:22:00Z","last_updated_date":"2022-09-20T14:22:00Z","reference_number":"EMADOC-1700519818-907465","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-prognostic-covariate-adjustment-procovatm_en.pdf"},
    {"id":"56169","name":"Direct healthcare professional communication (DHPC) : Metalyse® (tenecteplase) 8000 units (40 mg) and 10000 units (50 mg) powder and solvent for solution for injection: temporary supply shortage","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2022-09-23T09:11:00Z","last_updated_date":"2022-09-23T09:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-metalyser-tenecteplase-8000-units-40-mg-and-10000-units-50-mg-powder-and-solvent-solution-injection-temporary-supply-shortage_en.pdf"},
    {"id":"56170","name":"Implementing measures under Article 93(2) of Regulation (EU) 2019/6 as regards the good manufacturing practice for veterinary medicinal products and active substances used as starting materials","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-09-23T10:54:00Z","last_updated_date":"2022-09-23T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/implementing-measures-under-article-932-regulation-eu-20196-regards-good-manufacturing-practice-veterinary-medicinal-products-and-active-substances-used-starting-materials_en.pdf"},
    {"id":"56173","name":"2022-2025 Work plan for the Patients’ and Consumers’  Working Party (PCWP) and the Healthcare Professionals’  Working Party (HCPWP)","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2019-09-25T17:19:00Z","last_updated_date":"2023-01-26T14:31:00Z","reference_number":"EMA/22769/2022","document_url":"https://www.ema.europa.eu/en/documents/work-programme/2022-2025-work-plan-patients-and-consumers-working-party-pcwp-and-healthcare-professionals-working-party-hcpwp_en.pdf"},
    {"id":"56174","name":"Agenda - Second Veterinary Big Data Stakeholder Forum","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-09-23T15:08:00Z","last_updated_date":"2022-11-22T09:14:00Z","reference_number":"EMA/777506/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-veterinary-big-data-stakeholder-forum_en.pdf"},
    {"id":"56180","name":"Terms of reference of the HMA/EMA task force on availability of authorised medicines for human and veterinary use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-09-26T09:04:00Z","last_updated_date":"2022-10-10T09:26:00Z","reference_number":"EMA/857232/2016 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/terms-reference-hmaema-task-force-availability-authorised-medicines-human-and-veterinary-use_en.pdf"},
    {"id":"56189","name":"Addendum to Assessment report on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-09-26T16:02:00Z","last_updated_date":"2022-09-26T16:02:00Z","reference_number":"EMA/HMPC/30571/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"56191","name":"Overview of comments received on ICH guideline E11A on pediatric extrapolation Step 2bEMA/CHMP/ICH/205218/2022","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-09-26T17:36:00Z","last_updated_date":"2022-12-01T10:25:00Z","reference_number":"EMA/CHMP/ICH/205218/2022 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-ich-guideline-e11a-pediatric-extrapolation-step-2bemachmpich2052182022_en.pdf"},
    {"id":"56192","name":"Withdrawal assessment report for HemAryo","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-09-27T09:30:00Z","last_updated_date":"2022-09-27T09:30:00Z","reference_number":"EMA/CHMP/631976/2021","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-hemaryo_en.pdf"},
    {"id":"56194","name":"Veterinary Medicinal Products Regulation highlights - Issue 11","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T10:39:00Z","last_updated_date":"2022-09-27T10:39:00Z","reference_number":"Issue 11","document_url":"https://www.ema.europa.eu/en/documents/newsletter/veterinary-medicinal-products-regulation-highlights-issue-11_en.pdf"},
    {"id":"56196","name":"Public statement on Zalviso : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T10:55:00Z","last_updated_date":"2022-09-27T10:55:00Z","reference_number":"EMA/670718/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zalviso-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"56198","name":"Draft agenda - Training sessions for patients, consumers and healthcare professionals involved in medicine regulatory activities","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-09-27T11:04:00Z","last_updated_date":"2022-09-27T11:04:00Z","reference_number":"EMA/630927/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-training-sessions-patients-consumers-and-healthcare-professionals-involved-medicine-regulatory-activities_en.pdf"},
    {"id":"56199","name":"Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T12:18:00Z","last_updated_date":"2022-09-28T12:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-nulojix-belatacept-further-extension-temporary-restriction-supply-until-3q-2023_en.pdf"},
    {"id":"56200","name":"Presentation - EMA framework for engagement (M. Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T13:55:00Z","last_updated_date":"2022-09-27T13:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-framework-engagement-m-mavris-ema_en.pdf"},
    {"id":"56201","name":"Presentation - How patient engagement can contribute to the development and approval of medicines (Y. La Cam, EURORDIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T13:59:00Z","last_updated_date":"2022-09-27T13:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patient-engagement-can-contribute-development-and-approval-medicines-y-la-cam-eurordis_en.pdf"},
    {"id":"56202","name":"Presentation - How patients can contribute to the safety monitoring of medicines (S. Strauss, MEPRAC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:02:00Z","last_updated_date":"2022-09-27T14:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patients-can-contribute-safety-monitoring-medicines-s-strauss-meprac_en.pdf"},
    {"id":"56203","name":"Presentation - Survey results, proposed themes (L. D'Apote, EUCOPE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:12:00Z","last_updated_date":"2022-09-27T14:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-results-proposed-themes-l-dapote-eucope_en.pdf"},
    {"id":"56204","name":"Presentation - How patients can contribute to the development and regulation of medicines (J. Veldwijk, ESHPM)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:14:00Z","last_updated_date":"2022-09-27T14:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patients-can-contribute-development-and-regulation-medicines-j-veldwijk-eshpm_en.pdf"},
    {"id":"56205","name":"Presentation - Considerations and learnings from use-cases (M. Muller, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:16:00Z","last_updated_date":"2022-09-27T14:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-considerations-and-learnings-use-cases-m-muller-efpia_en.pdf"},
    {"id":"56206","name":"Presentation - Patient Preference Research (K. Morrigan, MPE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:21:00Z","last_updated_date":"2022-09-27T14:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-preference-research-k-morrigan-mpe_en.pdf"},
    {"id":"56207","name":"Presentation - PRO data generation in practice (C. Torre, UL)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:26:00Z","last_updated_date":"2022-09-27T14:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pro-data-generation-practice-c-torre-ul_en.pdf"},
    {"id":"56208","name":"Presentation - Clinical Outcome Assessment (COA) Implementation and Utility (E. Dashiell-Aje, EuropaBio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:29:00Z","last_updated_date":"2022-09-27T14:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-outcome-assessment-coa-implementation-and-utility-e-dashiell-aje-europabio_en.pdf"},
    {"id":"56209","name":"Presentation - European Health Data Space (J. De Barros, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:35:00Z","last_updated_date":"2022-09-27T14:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-health-data-space-j-de-barros-ec_en.pdf"},
    {"id":"56210","name":"Presentation - Data platforms (E. Vroom, WDO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T14:42:00Z","last_updated_date":"2022-09-27T14:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-platforms-e-vroom-wdo_en.pdf"},
    {"id":"56211","name":"Form for submission of comments on “Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources” (EMA/226421/2022)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2022-09-27T16:14:00Z","last_updated_date":"2022-09-27T16:14:00Z","reference_number":"EMA/226421/2022","document_url":"https://www.ema.europa.eu/en/documents/template-form/form-submission-comments-good-practice-guide-use-metadata-catalogue-real-world-data-sources-ema2264212022_en.doc"},
    {"id":"56213","name":"Ofloxacin (topical use) : List of nationally authorised medicinal products - PSUSA/00002204/202104","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T08:56:00Z","last_updated_date":"2022-09-28T08:56:00Z","reference_number":"EMA/788063/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/ofloxacin-topical-use-list-nationally-authorised-medicinal-products-psusa00002204202104_en.pdf"},
    {"id":"56214","name":"Triamcinolone (intraocular formulations) : List of nationally authorised medicinal products - PSUSA/00010292/202103","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T09:12:00Z","last_updated_date":"2022-09-28T09:12:00Z","reference_number":"EMA/788270/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/triamcinolone-intraocular-formulations-list-nationally-authorised-medicinal-products-psusa00010292202103_en.pdf"},
    {"id":"56215","name":"Presentation - EMA framework for engagement (M. Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:07:00Z","last_updated_date":"2022-09-28T10:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-framework-engagement-m-mavris-ema_en.pdf-0"},
    {"id":"56216","name":"Presentation - How patient engagement can contribute to the development and approval of medicines (Y. Le Cam, EURORDIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:08:00Z","last_updated_date":"2022-09-28T10:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patient-engagement-can-contribute-development-and-approval-medicines-y-le-cam-eurordis_en.pdf"},
    {"id":"56217","name":"Presentation - How patients can contribute to the safety monitoring of medicines (S. Strauss, MEPRAC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:09:00Z","last_updated_date":"2022-09-28T10:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patients-can-contribute-safety-monitoring-medicines-s-strauss-meprac_en.pdf-0"},
    {"id":"56218","name":"Presentation - Survey results, proposed themes (L. D'Apote, EUCOPE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:11:00Z","last_updated_date":"2022-09-28T10:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-results-proposed-themes-l-dapote-eucope_en.pdf-0"},
    {"id":"56219","name":"Presentation - how patient preferences can contribute to development and regulation of medicines (J. Veldwijk, ESHPM)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:20:00Z","last_updated_date":"2022-09-28T10:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-patient-preferences-can-contribute-development-and-regulation-medicines-j-veldwijk-eshpm_en.pdf"},
    {"id":"56220","name":"Presentation - Considerations and learnings from use-cases (M. Muller, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:23:00Z","last_updated_date":"2022-09-28T10:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-considerations-and-learnings-use-cases-m-muller-efpia_en.pdf-0"},
    {"id":"56221","name":"Presentation - Patient Preference Research (K. Morgan, MPE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:25:00Z","last_updated_date":"2022-09-28T10:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-preference-research-k-morgan-mpe_en.pdf"},
    {"id":"56222","name":"Presentation - PRO data generation in practice (C. Torre, UL)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:28:00Z","last_updated_date":"2022-09-28T10:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pro-data-generation-practice-c-torre-ul_en.pdf-0"},
    {"id":"56223","name":"Withdrawal assessment report for Imcivree","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-09-28T10:39:00Z","last_updated_date":"2022-09-28T10:39:00Z","reference_number":"EMA/677095/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-imcivree_en.pdf"},
    {"id":"56224","name":"Presentation - Clinical Outcome Assessment (COA) Implementation and Utility (E. Dashiell-Aje, EuropaBio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:36:00Z","last_updated_date":"2022-09-28T10:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-outcome-assessment-coa-implementation-and-utility-e-dashiell-aje-europabio_en.pdf-0"},
    {"id":"56225","name":"Presentation - European Health Data Space (J. De Barros, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:43:00Z","last_updated_date":"2022-09-28T10:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-health-data-space-j-de-barros-ec_en.pdf-0"},
    {"id":"56227","name":"Presentation - Data platforms (E. Vroom, WDO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T10:49:00Z","last_updated_date":"2022-09-28T10:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-platforms-e-vroom-wdo_en.pdf-0"},
    {"id":"56228","name":"Presentation - Qualification of novel methodologies (T. Vetter, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T11:11:00Z","last_updated_date":"2022-09-28T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qualification-novel-methodologies-t-vetter-ema_en.pdf"},
    {"id":"56229","name":"Presentation - Patient experience data in decision making and future guidance (S. Bhatti, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T11:17:00Z","last_updated_date":"2022-09-28T11:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-decision-making-and-future-guidance-s-bhatti-efpia_en.pdf"},
    {"id":"56232","name":"Presentation - ICH Patient-focused drug development (PFDD) initiative (M. Bonelli, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T11:23:00Z","last_updated_date":"2022-09-28T11:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-patient-focused-drug-development-pfdd-initiative-m-bonelli-ema_en.pdf"},
    {"id":"56233","name":"Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-10-26T12:18:00Z","last_updated_date":"2022-10-26T12:18:00Z","reference_number":"EMA/CAT/CHMP/158266/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-labelling-and-package-leaflet-advanced-therapy-medicinal-products-atmps-containing-genetically-modified-cells_en.pdf"},
    {"id":"56235","name":"Presentation - Tools to collect patient generated data (T. Stamm, MUV)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-28T11:28:00Z","last_updated_date":"2022-09-28T11:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-tools-collect-patient-generated-data-t-stamm-muv_en.pdf"},
    {"id":"56240","name":"Rubraca Article-20 referral - Public assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2022-09-28T17:19:00Z","last_updated_date":"2022-09-28T17:19:00Z","reference_number":"EMA/674344/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/rubraca-article-20-referral-public-assessment-report_en.pdf"},
    {"id":"56241","name":"Presentation - Update on COVID-19 and Monkeypoxvaccines and therapeutics (M.Cavaleri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-covid-19-and-monkeypoxvaccines-and-therapeutics-mcavaleri-ema_en.pdf"},
    {"id":"56242","name":"Presentation - Updates on pharmacovigilance and new initiatives for risk minimisation (P.Bahri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-pharmacovigilance-and-new-initiatives-risk-minimisation-pbahri-ema_en.pdf"},
    {"id":"56243","name":"Presentation - Policy Brief on medicines for children and rare diseases (I.Proano Gomez, EFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-policy-brief-medicines-children-and-rare-diseases-iproano-gomez-efa_en.pdf"},
    {"id":"56244","name":"Presentation - PCWP/HCPWP contribution to ICH E6(R3) guidance on good clinical practice (GCP) (F.Houyez, PCWP; P.Szymanski, HCPWP; K.Pietsch, EMA; I.Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwphcpwp-contribution-ich-e6r3-guidance-good-clinical-practice-gcp-fhouyez-pcwp-pszymanski-hcpwp-kpietsch-ema-isilva-ema_en.pdf"},
    {"id":"56245","name":"Presentation - Engagement and communication with EMA eligible HCP organisations - Policy Officers’ Group progress update from drafting groups (I.Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-engagement-and-communication-ema-eligible-hcp-organisations-policy-officers-group-progress-update-drafting-groups-isilva-ema_en.pdf"},
    {"id":"56246","name":"Presentation - Feedback on ATMP dedicated webinar on 28 June 2022 (M.Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-atmp-dedicated-webinar-28-june-2022-mmavris-ema_en.pdf"},
    {"id":"56247","name":"Presentation - Election of PCWP co-chair, 2022-2025 (M.Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-election-pcwp-co-chair-2022-2025-mmavris-ema_en.pdf"},
    {"id":"56248","name":"Presentation - Election of HCPWP co-chair, 2022-2025 (I.Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-election-hcpwp-co-chair-2022-2025-isilva-ema_en.pdf"},
    {"id":"56249","name":"Presentation - Consumer group surveys on drug shortages (A.la Santos, BEUC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T09:41:00Z","last_updated_date":"2022-09-29T09:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-consumer-group-surveys-drug-shortages-ala-santos-beuc_en.pdf"},
    {"id":"56250","name":"Agenda - Joint Meeting of the CTTI-FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T10:16:00Z","last_updated_date":"2022-09-29T10:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-meeting-ctti-fda-patient-engagement-collaborative-pec-and-ema-patients-and-consumers-working-party-pcwp_en.pdf"},
    {"id":"56251","name":"Meeting report of the Joint Meeting of the CTTI-FDA Patient Engagement Collaborative (PEC) and EMA Patients and Consumers Working Party (PCWP) on 15 July 2022","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T10:23:00Z","last_updated_date":"2022-09-29T10:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-joint-meeting-ctti-fda-patient-engagement-collaborative-pec-and-ema-patients-and-consumers-working-party-pcwp-15-july-2022_en.pdf"},
    {"id":"56252","name":"Presentation - Patient's Reported Outcomes (PRO) role in clinical development and approval decisions (A.Elferink, MEBSAWP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T10:28:00Z","last_updated_date":"2022-09-29T10:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-reported-outcomes-pro-role-clinical-development-and-approval-decisions-aelferink-mebsawp_en.pdf"},
    {"id":"56253","name":"Alverine / simeticone : List of nationally authorised medicinal products - PSUSA/00000125/202202","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T15:20:00Z","last_updated_date":"2022-09-29T15:20:00Z","reference_number":"EMA/793021/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/alverine-simeticone-list-nationally-authorised-medicinal-products-psusa00000125202202_en.pdf"},
    {"id":"56254","name":"Alverine : List of nationally authorised medicinal products - PSUSA/00000124/202202","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-29T15:27:00Z","last_updated_date":"2022-09-29T15:27:00Z","reference_number":"EMA/793085/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/alverine-list-nationally-authorised-medicinal-products-psusa00000124202202_en.pdf"},
    {"id":"56261","name":"Zanamivir (except for centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00003141/202201","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T11:19:00Z","last_updated_date":"2022-09-30T11:19:00Z","reference_number":"EMA/638586/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/zanamivir-except-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00003141202201_en.pdf"},
    {"id":"56262","name":"Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T11:26:00Z","last_updated_date":"2022-09-30T11:26:00Z","reference_number":"EMA/674694/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa00010298202203_en.pdf"},
    {"id":"56263","name":"Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T11:31:00Z","last_updated_date":"2022-09-30T11:31:00Z","reference_number":"EMA/674604/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa00001744202203_en.pdf"},
    {"id":"56264","name":"Loratadine : List of nationally authorised medicinal products - PSUSA/00001907/202202","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T11:46:00Z","last_updated_date":"2022-09-30T11:46:00Z","reference_number":"EMA/794351/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/loratadine-list-nationally-authorised-medicinal-products-psusa00001907202202_en.pdf"},
    {"id":"56265","name":"PRAC statistics: October 2022","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T11:47:00Z","last_updated_date":"2022-09-30T11:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-october-2022_en.pdf"},
    {"id":"56266","name":"Cromoglicic acid : List of nationally authorised medicinal products - PSUSA/00000883/202202","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T11:52:00Z","last_updated_date":"2022-09-30T11:52:00Z","reference_number":"EMA/781338/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/cromoglicic-acid-list-nationally-authorised-medicinal-products-psusa00000883202202_en.pdf"},
    {"id":"56267","name":"Loratadine / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00001908/202202","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T12:41:00Z","last_updated_date":"2022-09-30T12:41:00Z","reference_number":"EMA/794502/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/loratadine-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa00001908202202_en.pdf"},
    {"id":"56269","name":"Presentation - Product Management Services (PMS) Sub-Groups (SG) Webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T15:57:00Z","last_updated_date":"2022-09-30T15:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-management-services-pms-sub-groups-sg-webinar_en.pdf"},
    {"id":"56270","name":"Highlights from the eighth meeting of the Nitrosamine Implementation Oversight Group (NIOG)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-09-30T16:47:00Z","last_updated_date":"2022-09-30T16:47:00Z","reference_number":"EMA/735626/2022","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-eighth-meeting-nitrosamine-implementation-oversight-group-niog_en.pdf"},
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    {"id":"56355","name":"Highlights of the fifth EMA - Medicines for Europe bilateral meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-10-10T11:28:00Z","last_updated_date":"2022-10-10T11:28:00Z","reference_number":"EMA/775191/2021","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-fifth-ema-medicines-europe-bilateral-meeting_en.pdf"},
    {"id":"56356","name":"Agenda of the CHMP meeting 10-13 October 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-10-10T12:14:00Z","last_updated_date":"2022-10-10T12:14:00Z","reference_number":"EMA/CHMP/770559/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-10-13-october-2022_en.pdf"},
    {"id":"56359","name":"Presentation - EMA Account Management Training Session","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-10-11T11:43:00Z","last_updated_date":"2022-10-11T11:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-account-management-training-session_en.pdf"},
    {"id":"56360","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - June 2022","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2022-10-11T16:58:00Z","last_updated_date":"2022-10-11T16:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-june-2022_en.pdf"},
    {"id":"56362","name":"Questions and answers - IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry users","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-10-11T17:07:00Z","last_updated_date":"2022-10-11T17:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-iris-good-pharmacovigilance-practice-gvp-inspections-training-session-industry-users_en.pdf"},
    {"id":"56363","name":"Agenda of the PDCO meeting 11-14 October 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-10-12T12:03:00Z","last_updated_date":"2022-10-12T12:03:00Z","reference_number":"EMA/PDCO/764496/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-meeting-11-14-october-2022_en.pdf"},
    {"id":"56364","name":"Questions and answers - DADI PDF electronic application forms (eAF) training webinars (26 July 2022 and 2 September 2022)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-10-12T17:02:00Z","last_updated_date":"2022-10-12T17:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-dadi-pdf-electronic-application-forms-eaf-training-webinars-26-july-2022-and-2-september-2022_en.pdf"},
    {"id":"56365","name":"Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-10-12T12:21:00Z","last_updated_date":"2022-10-12T12:21:00Z","reference_number":"EMA/665019/2022","document_url":"https://www.ema.europa.eu/en/documents/report/pilot-early-dialogue-patient-organisations-orphan-marketing-authorisation-applications-outcome-report_en.pdf"},
    {"id":"56372","name":"Minutes of the 116th meeting of the Management Board: 15-16 June 2022","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2022-10-12T14:35:00Z","last_updated_date":"2022-10-12T14:35:00Z","reference_number":"EMA/MB/592684/2022","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-116th-meeting-management-board-15-16-june-2022_en.pdf"},
    {"id":"56375","name":"Human medicines highlights - September 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-10-12T17:59:00Z","last_updated_date":"2022-10-12T17:59:00Z","reference_number":"Issue 162","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-september-2022_en.pdf"},
    {"id":"56376","name":"Human medicines highlights - September 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-10-12T17:59:00Z","last_updated_date":"2022-10-12T17:59:00Z","reference_number":"Issue 162","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-september-2022_en.pdf-0"},
    {"id":"56378","name":"Agenda - Data Quality Framework for EU medicines regulation (1st draft): webinar to support public consultation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-10-13T10:01:00Z","last_updated_date":"2022-10-13T10:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-data-quality-framework-eu-medicines-regulation-1st-draft-webinar-support-public-consultation_en.pdf"},
    {"id":"56379","name":"Agenda - Data Quality Framework for EU medicines regulation (1st draft): webinar to support public consultation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-10-13T10:03:00Z","last_updated_date":"2022-10-13T10:03:00Z","reference_number":"EMA/822839/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-data-quality-framework-eu-medicines-regulation-1st-draft-webinar-support-public-consultation_en.pdf-0"},
    {"id":"56387","name":"CHMP post-authorisation summary of positive opinion for Xydalba (II-43)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/787460/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xydalba-ii-43_en.pdf"},
    {"id":"56390","name":"Agenda - EMA – Parenteral Drug Association bilateral meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-11-28T11:47:00Z","last_updated_date":"2022-11-28T11:47:00Z","reference_number":"EMA/795101/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-parenteral-drug-association-bilateral-meeting_en.pdf"},
    {"id":"56397","name":"CHMP summary of positive opinion for Pluvicto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/793918/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pluvicto_en.pdf"},
    {"id":"56398","name":"Overview of comments received on 'Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-10-14T09:30:00Z","last_updated_date":"2022-10-14T09:30:00Z","reference_number":"EMA/CVMP/352510/2022","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-criteria-determining-active-substance-essential-when-considered-context-article-372j-regulation-20196_en.pdf"},
    {"id":"56399","name":"Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T09:31:00Z","last_updated_date":"2022-10-14T09:31:00Z","reference_number":"EMA/CVMP/116512/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-criteria-determining-active-substance-essential-when-considered-context-article-372j-regulation-eu-20196_en.pdf"},
    {"id":"56400","name":"CHMP summary of positive opinion for Locametz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/742076/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-locametz_en.pdf"},
    {"id":"56401","name":"CHMP post-authorisation summary of positive opinion for Libtayo (II-26)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/820786/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-libtayo-ii-26_en.pdf"},
    {"id":"56404","name":"CHMP summary of positive opinion for Ebvallo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/791184/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ebvallo_en.pdf"},
    {"id":"56405","name":"CHMP summary of positive opinion for Eladynos","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-13T17:00:00Z","last_updated_date":"2022-10-13T17:00:00Z","reference_number":"EMA/806878/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eladynos_en.pdf"},
    {"id":"56406","name":"CHMP post-authorisation summary of positive opinion for Lyumjev (II-14)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T17:08:00Z","last_updated_date":"2022-10-14T17:08:00Z","reference_number":"EMA/CHMP/805193/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lyumjev-ii-14_en.pdf"},
    {"id":"56408","name":"CHMP summary of positive opinion for Spevigo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/804058/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-spevigo_en.pdf"},
    {"id":"56409","name":"CHMP summary of positive opinion for Livmarli","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/803191/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-livmarli_en.pdf"},
    {"id":"56410","name":"Scientific advice and protocol assistance adopted during the CHMP meeting 10-13 October 2022","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/SAWP/827118/2022","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-10-13-october-2022_en.pdf"},
    {"id":"56411","name":"CHMP post-authorisation summary of positive opinion for Brukinsa (II-03)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/815806/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-brukinsa-ii-03_en.pdf"},
    {"id":"56412","name":"CHMP summary of positive opinion for Pemetrexed Baxter","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/808787/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pemetrexed-baxter_en.pdf"},
    {"id":"56413","name":"Questions and answers on the withdrawal for the marketing authorisation of Hervelous (trastuzumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2022-10-14T11:43:00Z","last_updated_date":"2022-12-13T12:00:00Z","reference_number":"EMA/807465/2022 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-hervelous-trastuzumab_sv.pdf"}},
    {"id":"56414","name":"Withdrawal letter: Hervelous","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-10-14T11:46:00Z","last_updated_date":"2022-10-14T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-hervelous_en.pdf"},
    {"id":"56415","name":"CHMP summary of positive opinion for Qdenga","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:00:00Z","last_updated_date":"2022-10-14T12:00:00Z","reference_number":"EMA/CHMP/781052/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-qdenga_en.pdf"},
    {"id":"56416","name":"Questions and answers on the withdrawal for the marketing authorisation of Tuznue (trastuzumab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2022-10-14T11:55:00Z","last_updated_date":"2022-12-13T15:28:00Z","reference_number":"EMA/807453/2022","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-tuznue-trastuzumab_sv.pdf"}},
    {"id":"56417","name":"Withdrawal letter: Tuznue","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-10-14T11:57:00Z","last_updated_date":"2022-10-14T11:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-tuznue_en.pdf"},
    {"id":"56418","name":"CHMP summary of positive opinion for Dengue Tetravalent Vaccine (Live, Attenuated) Takeda","type":"outside-EU-smop","status":"Adopted","consultation_date":"","first_published_date":"2022-10-14T12:17:00Z","last_updated_date":"2022-10-14T12:17:00Z","reference_number":"EMA/CHMP/781055/2022","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-smop/chmp-summary-positive-opinion-dengue-tetravalent-vaccine-live-attenuated-takeda_en.pdf"},
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    {"id":"56423","name":"Public statement on Glidipion : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-10-17T11:31:00Z","last_updated_date":"2022-10-17T11:31:00Z","reference_number":"EMA/667468/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-glidipion-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"56425","name":"Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC May 2022 meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-10-17T12:49:00Z","last_updated_date":"2022-10-17T12:49:00Z","reference_number":"EMA/HMPC/609605/2022","document_url":"https://www.ema.europa.eu/en/documents/report/hearing-association-european-self-medication-industry-aesgp-during-hmpc-may-2022-meeting_en.pdf"},
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    {"id":"56431","name":"Public statement on Glubrava : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-10-18T16:08:00Z","last_updated_date":"2022-10-18T16:08:00Z","reference_number":"EMA/366895/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-glubrava-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"56433","name":"Ciclosporin (systemic use) : List of nationally authorised medicinal products - PSUSA/00000745/202112","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-10-19T14:03:00Z","last_updated_date":"2022-10-19T14:03:00Z","reference_number":"EMA/837430/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciclosporin-systemic-use-list-nationally-authorised-medicinal-products-psusa00000745202112_en.pdf"},
    {"id":"56434","name":"Ciclosporin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"56588","name":"CHMP post-authorisation summary of positive opinion for Imfinzi (II-46)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T12:00:00Z","last_updated_date":"2022-11-11T12:00:00Z","reference_number":"EMA/858595/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imfinzi-ii-46_en.pdf"},
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    {"id":"56590","name":"Terlipressin-containing medicinal products Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T09:51:00Z","last_updated_date":"2022-12-22T12:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_fr.pdf","ga":"https://www.ema.europa.eu/ga/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_ga.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-annex-iii_sv.pdf"}},
    {"id":"56591","name":"Terlipressin-containing medicinal products Article-31 referral - Timetable for the implementation of the CMDh position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T09:53:00Z","last_updated_date":"2022-11-11T09:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/terlipressin-containing-medicinal-products-article-31-referral-timetable-implementation-cmdh-position_en.pdf"},
    {"id":"56593","name":"Presentation - Human variations eAF Form (DADI) training session","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T10:37:00Z","last_updated_date":"2022-11-11T10:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-human-variations-eaf-form-dadi-training-session_en.pdf"},
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    {"id":"56595","name":"CHMP post-authorisation summary of positive opinion for Lynparza (II-53)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T12:00:00Z","last_updated_date":"2022-11-11T12:00:00Z","reference_number":"EMA/CHMP/822269/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lynparza-ii-53_en.pdf"},
    {"id":"56597","name":"CHMP summary of positive opinion for Pirfenidone Viatris","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T12:00:00Z","last_updated_date":"2022-11-11T12:00:00Z","reference_number":"EMA/CHMP/846957/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pirfenidone-viatris_en.pdf"},
    {"id":"56598","name":"Janus Kinase inhibitors (JAKi) Article-20 procedure - EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-01-27T12:27:00Z","last_updated_date":"2023-01-27T12:27:00Z","reference_number":"EMA/27681/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/janus-kinase-inhibitors-jaki-article-20-procedure-ema-confirms-measures-minimise-risk-serious-side-effects-janus-kinase-inhibitors-chronic-inflammatory-disorders_en.pdf"},
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    {"id":"56621","name":"Agenda - Second European Medicines Agency and Affordable Medicines Europe bilateral meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-11-16T09:24:00Z","last_updated_date":"2022-11-16T09:24:00Z","reference_number":"EMA/845891/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-european-medicines-agency-and-affordable-medicines-europe-bilateral-meeting_en.pdf"},
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    {"id":"56632","name":"Jyseleca : EPAR - Product information as approved by the CHMP on 23 January 2023, pending endorsement by the European Commission","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-11-15T16:38:00Z","last_updated_date":"2023-01-27T12:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/jyseleca-epar-product-information-approved-chmp-23-january-2023-pending-endorsement-european-commission_en.pdf"},
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    {"id":"56639","name":"Agenda - Quarterly system demo - Q4 2022","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-11-16T10:37:00Z","last_updated_date":"2022-12-16T09:48:00Z","reference_number":"EMA/884121/2022 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-quarterly-system-demo-q4-2022_en.pdf"},
    {"id":"56640","name":"Withdrawal assessment report for Sevsury","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-11-16T11:20:00Z","last_updated_date":"2022-11-16T11:20:00Z","reference_number":"EMA/CHMP/697928/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-sevsury_en.pdf"},
    {"id":"56641","name":"Austria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/austria-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56642","name":"Belgium - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/belgium-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56643","name":"Bulgaria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/bulgaria-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56644","name":"Croatia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/croatia-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56645","name":"Cyprus - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/cyprus-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56647","name":"Denmark - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/denmark-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56648","name":"Estonia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/estonia-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56649","name":"Finland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/finland-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56651","name":"France - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/france-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56652","name":"Germany - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/germany-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56653","name":"Greece - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/greece-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56654","name":"Hungary - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/hungary-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56655","name":"Iceland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/iceland-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56656","name":"Ireland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/ireland-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56657","name":"Italy - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/italy-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56658","name":"Latvia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/latvia-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56659","name":"Lithuania - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/lithuania-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56660","name":"Luxembourg - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/luxembourg-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56661","name":"Malta - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/malta-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56662","name":"Netherlands - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/netherlands-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56663","name":"Norway - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/norway-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56664","name":"Poland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/poland-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56665","name":"Portugal - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/portugal-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56666","name":"Romania - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/romania-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56667","name":"Slovakia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/slovakia-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56668","name":"Slovenia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/slovenia-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56669","name":"Spain - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/spain-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56671","name":"Switzerland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/switzerland-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56672","name":"United Kingdom - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-11-18T09:00:00Z","last_updated_date":"2022-11-18T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/united-kingdom-sales-trends-mgpcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2021_en.pdf"},
    {"id":"56673","name":"Public statement on Neurobloc : Cessation of marketing in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-11-16T15:12:00Z","last_updated_date":"2022-11-16T15:12:00Z","reference_number":"EMA/305129/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-neurobloc-cessation-marketing-european-union_en.pdf"},
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    {"id":"56791","name":"Appendix 1 - Pharmacovigilance Inspection Report template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2022-11-29T11:36:00Z","last_updated_date":"2022-11-29T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-1-pharmacovigilance-inspection-report-template_en.doc"},
    {"id":"56792","name":"Appendix 2 - Template for collecting information on Pharmacovigilance issues for the attention of the inspectors and assessors","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2022-11-29T11:43:00Z","last_updated_date":"2022-11-29T11:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/appendix-2-template-collecting-information-pharmacovigilance-issues-attention-inspectors-and-assessors_en.doc"},
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    {"id":"56862","name":"Diphtheria/tetanus/pertussis (acellular, component) vaccine (adsorbed), diphtheria/tetanus/pertussis (acellular, component) vaccine (adsorbed) reduced antigens contents: List of nationally authorised medicinal pr...","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-02T12:32:00Z","last_updated_date":"2022-12-02T12:32:00Z","reference_number":"EMA/759342/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheriatetanuspertussis-acellular-component-vaccine-adsorbed-diphtheriatetanuspertussis-acellular-component-vaccine-adsorbed-reduced-antigens-contents-list-nationally-authorised-medicinal-pr_en.pdf"},
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    {"id":"56878","name":"Mometasone furoate/olopatadine : List of nationally authorised medicinal products - PSUSA/00010957/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-05T11:52:00Z","last_updated_date":"2022-12-05T11:52:00Z","reference_number":"EMA/918585/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/mometasone-furoateolopatadine-list-nationally-authorised-medicinal-products-psusa00010957202204_en.pdf"},
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    {"id":"56881","name":"Sertraline : List of nationally authorised medicinal products - PSUSA/00002696/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-06T09:20:00Z","last_updated_date":"2022-12-06T09:20:00Z","reference_number":"EMA/PRAC/918194/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/sertraline-list-nationally-authorised-medicinal-products-psusa00002696202203_en.pdf"},
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    {"id":"56887","name":"Questions and answers - Human Variations eAF go-live Q&A session (8 November 2022)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-06T13:19:00Z","last_updated_date":"2022-12-06T13:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-human-variations-eaf-go-live-qa-session-8-november-2022_en.pdf"},
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    {"id":"56890","name":"ETF statement on the use of the EMA approved bivalent original / Omicron BA.4-5 mRNA vaccines for primary series","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-06T16:22:00Z","last_updated_date":"2022-12-06T16:22:00Z","reference_number":"EMA/922920/2022","document_url":"https://www.ema.europa.eu/en/documents/other/etf-statement-use-ema-approved-bivalent-original-omicron-ba4-5-mrna-vaccines-primary-series_en.pdf"},
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    {"id":"56900","name":"Presentation - Role of academic clinical trials (D. Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-07T17:35:00Z","last_updated_date":"2022-12-07T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-academic-clinical-trials-d-karres_en.pdf"},
    {"id":"56901","name":"Presentation - WG on cross-border trials (B. Nafria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-07T17:35:00Z","last_updated_date":"2022-12-07T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-wg-cross-border-trials-b-nafria_en.pdf"},
    {"id":"56902","name":"Presentation - WG on off-label evidence (S. De Wildt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-07T17:35:00Z","last_updated_date":"2022-12-07T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-wg-label-evidence-s-de-wildt_en.pdf"},
    {"id":"56903","name":"Presentation - WG on research nurses (P. Dicks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-07T17:35:00Z","last_updated_date":"2022-12-07T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-wg-research-nurses-p-dicks_en.pdf"},
    {"id":"56904","name":"Agenda - 2022 annual meeting of the members and Coordinating Group of Enpr-EMA","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-07T17:30:00Z","last_updated_date":"2022-12-07T17:30:00Z","reference_number":"EMA/564166/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2022-annual-meeting-members-and-coordinating-group-enpr-ema_en.pdf"},
    {"id":"56910","name":"Agenda - Human variations electronic application forms Q&A clinics – session 5","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T13:32:00Z","last_updated_date":"2022-12-08T13:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-human-variations-electronic-application-forms-qa-clinics-session-5_en.pdf"},
    {"id":"56911","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 21-23 November 2022","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T13:49:00Z","last_updated_date":"2022-12-08T13:49:00Z","reference_number":"EMA/HMPC/907971/2022","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-21-23-november-2022_en.pdf"},
    {"id":"56912","name":"Epoprostenol : List of nationally authorised medicinal products - PSUSA/00001242/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T16:19:00Z","last_updated_date":"2022-12-08T16:19:00Z","reference_number":"EMA/931498/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/epoprostenol-list-nationally-authorised-medicinal-products-psusa00001242202203_en.pdf"},
    {"id":"56913","name":"Possible use of the medicinal product TPOXX for the treatment of monkeypox","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T17:15:00Z","last_updated_date":"2022-12-08T17:15:00Z","reference_number":"EMA/904994/2022","document_url":"https://www.ema.europa.eu/en/documents/other/possible-use-medicinal-product-tpoxx-treatment-monkeypox_en.pdf"},
    {"id":"56915","name":"Oncology Working Party (ONCWP) work plan 2022-2024","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T17:07:00Z","last_updated_date":"2023-06-16T15:27:00Z","reference_number":"EMA/CHMP/277603/2023","document_url":"https://www.ema.europa.eu/en/documents/work-programme/oncology-working-party-oncwp-work-plan-2022-2024_en.pdf"},
    {"id":"56917","name":"Candesartan, candesartan / hydrochlorothiazide - List of nationally authorised medicinal products - PSUSA/00000527/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T17:28:00Z","last_updated_date":"2022-12-08T17:28:00Z","reference_number":"EMA/929096/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/candesartan-candesartan-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa00000527202204_en.pdf"},
    {"id":"56918","name":"Carvedilol - List of nationally authorised medicinal products - PSUSA/00000575/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T17:54:00Z","last_updated_date":"2022-12-08T17:54:00Z","reference_number":"EMA/929400/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/carvedilol-list-nationally-authorised-medicinal-products-psusa00000575202204_en.pdf"},
    {"id":"56919","name":"Letter of support for TREAT-NMD Core Dataset for Spinal Muscular Atrophy (SMA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-08T17:55:00Z","last_updated_date":"2022-12-08T17:55:00Z","reference_number":"EMADOC-1700519818-958775","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-treat-nmd-core-dataset-spinal-muscular-atrophy-sma_en.pdf"},
    {"id":"56920","name":"Certoparin : List of nationally authorised medicinal products - PSUSA/00000625/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T08:57:00Z","last_updated_date":"2022-12-09T08:57:00Z","reference_number":"EMA/929591/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/certoparin-list-nationally-authorised-medicinal-products-psusa00000625202204_en.pdf"},
    {"id":"56922","name":"Amlodipine / olmesartan : List of nationally authorised medicinal products - PSUSA/00002208/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T13:27:00Z","last_updated_date":"2022-12-09T13:27:00Z","reference_number":"EMA/933404/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-olmesartan-list-nationally-authorised-medicinal-products-psusa00002208202204_en.pdf"},
    {"id":"56923","name":"Ethinylestradiol / levonorgestrel : List of nationally authorised medicinal products - PSUSA/00001309/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T13:38:00Z","last_updated_date":"2022-12-09T13:38:00Z","reference_number":"EMA/933038/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethinylestradiol-levonorgestrel-list-nationally-authorised-medicinal-products-psusa00001309202204_en.pdf"},
    {"id":"56924","name":"Amlodipine besilate / hydrochlorothiazide / olmesartan medoxomil : List of nationally authorised medicinal products - PSUSA/00002210/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T13:56:00Z","last_updated_date":"2022-12-09T13:56:00Z","reference_number":"EMA/933936/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-besilate-hydrochlorothiazide-olmesartan-medoxomil-list-nationally-authorised-medicinal-products-psusa00002210202204_en.pdf"},
    {"id":"56925","name":"ETF statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants of concern","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T13:58:00Z","last_updated_date":"2022-12-09T13:58:00Z","reference_number":"EMA/931457/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/etf-statement-loss-activity-anti-spike-protein-monoclonal-antibodies-due-emerging-sars-cov-2-variants-concern_en.pdf"},
    {"id":"56926","name":"CVMP summary of positive opinion for Brucellin Aquilon","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-12-09T15:00:00Z","last_updated_date":"2022-12-09T15:00:00Z","reference_number":"EMA/CVMP/889858/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-brucellin-aquilon_en.pdf"},
    {"id":"56927","name":"CVMP post-authorisation summary of positive opinion for Credelio Plus","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-12-09T15:33:00Z","last_updated_date":"2022-12-09T15:33:00Z","reference_number":"EMA/CVMP/903852/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-credelio-plus_en.pdf"},
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    {"id":"56931","name":"Sulprostone : List of nationally authorised medicinal products - PSUSA/00002828/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T15:19:00Z","last_updated_date":"2022-12-09T15:19:00Z","reference_number":"EMA/933959/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/sulprostone-list-nationally-authorised-medicinal-products-psusa00002828202204_en.pdf"},
    {"id":"56932","name":"Amlodipine / candesartan : List of nationally authorised medicinal products - PSUSA/00010191/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T15:24:00Z","last_updated_date":"2022-12-09T15:24:00Z","reference_number":"EMA/934243/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-candesartan-list-nationally-authorised-medicinal-products-psusa00010191202204_en.pdf"},
    {"id":"56933","name":"Carvedilol / ivabradine : List of nationally authorised medicinal products - PSUSA/00010883/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T15:50:00Z","last_updated_date":"2022-12-09T15:50:00Z","reference_number":"EMA/934540/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/carvedilol-ivabradine-list-nationally-authorised-medicinal-products-psusa00010883202204_en.pdf"},
    {"id":"56934","name":"Agenda - Regulatory and scientific virtual conference on RNA-based medicines","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-09T16:15:00Z","last_updated_date":"2023-02-09T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-regulatory-and-scientific-virtual-conference-rna-based-medicines_en.pdf"},
    {"id":"56935","name":"Agenda of the CHMP meeting 12-15 December 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-12-12T11:05:00Z","last_updated_date":"2022-12-12T11:05:00Z","reference_number":"EMA/CHMP/869948/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-12-15-december-2022_en.pdf"},
    {"id":"56937","name":"Estradiol / norethisterone - List of nationally authorised medicinal products - PSUSA/00001278/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2022-12-12T12:26:00Z","last_updated_date":"2022-12-12T12:26:00Z","reference_number":"EMA/934662/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/estradiol-norethisterone-list-nationally-authorised-medicinal-products-psusa00001278202203_en.pdf"},
    {"id":"56939","name":"Overview of comments received on ICH Harmonized Guideline Drug Interactions M12 (EMA/CHMP/ICH/652460/2022)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-12-12T16:25:00Z","last_updated_date":"2022-12-12T16:25:00Z","reference_number":"EMA/CHMP/ICH/652460/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-ich-harmonized-guideline-drug-interactions-m12-emachmpich6524602022_en.pdf"},
    {"id":"56946","name":"Human medicines highlights - December 2022","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T09:34:00Z","last_updated_date":"2022-12-13T09:34:00Z","reference_number":"Issue 164","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-december-2022_en.pdf"},
    {"id":"56949","name":"Session 1 - Overview of 2022 deliverables and the new plan for 2022-2025 (Peter Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T09:46:00Z","last_updated_date":"2022-12-13T09:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-1-overview-2022-deliverables-and-new-plan-2022-2025-peter-arlett_en.pdf"},
    {"id":"56950","name":"Session 2-1 - DARWIN EU ® – first experiences and regulatory use case (Xavier Kurz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T09:55:00Z","last_updated_date":"2022-12-13T09:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-2-1-darwin-eu-r-first-experiences-and-regulatory-use-case-xavier-kurz_en.pdf"},
    {"id":"56951","name":"Session 2-2 - HTA DARWIN use case examples (Niklas Hedberg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T09:57:00Z","last_updated_date":"2022-12-13T09:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-2-2-hta-darwin-use-case-examples-niklas-hedberg_en.pdf"},
    {"id":"56952","name":"Session 2-3 - Payers DARWIN Use case examples (Wim Goettsch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:14:00Z","last_updated_date":"2022-12-13T10:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-2-3-payers-darwin-use-case-examples-wim-goettsch_en.pdf"},
    {"id":"56953","name":"Session 2-4 - EU Data Quality Framework for medicines regulation – launch and collaboration (Ana Cochino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-2-4-eu-data-quality-framework-medicines-regulation-launch-and-collaboration-ana-cochino_en.pdf"},
    {"id":"56954","name":"Session 3-1 - EU Real World metadata list, good practice guide and catalogues of data sources and studies (Katerina Deli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-3-1-eu-real-world-metadata-list-good-practice-guide-and-catalogues-data-sources-and-studies-katerina-deli_en.pdf"},
    {"id":"56955","name":"Session 3-2 Artificial Intelligence in Medicines Regulation (Gabriel Westman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-3-2-artificial-intelligence-medicines-regulation-gabriel-westman_en.pdf"},
    {"id":"56956","name":"Session 3-3 Regulatory capability to analyse data - Clinical trial raw data (Joerg Zinserling)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-3-3-regulatory-capability-analyse-data-clinical-trial-raw-data-joerg-zinserling_en.pdf"},
    {"id":"56957","name":"Session 4-1 European Health Data Space (Jerome De Barros)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-1-european-health-data-space-jerome-de-barros_en.pdf"},
    {"id":"56958","name":"Session 4-2 -Towards European Health Data Space (TEHDAS) (Shona Cosgrove)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-2-towards-european-health-data-space-tehdas-shona-cosgrove_en.pdf"},
    {"id":"56959","name":"Session 4-3 - EHDS2 (Pilot Mario Jendrossek)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-3-ehds2-pilot-mario-jendrossek_en.pdf"},
    {"id":"56960","name":"Session 4-4 - Implementation status of the ERMN Data standardization strategy (Nick Halsey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:18:00Z","last_updated_date":"2022-12-13T10:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-4-implementation-status-ermn-data-standardization-strategy-nick-halsey_en.pdf"},
    {"id":"56961","name":"Session 4-5 - Collaboration on international initiatives (Sean Barry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:51:00Z","last_updated_date":"2022-12-13T10:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-5-collaboration-international-initiatives-sean-barry_en.pdf"},
    {"id":"56962","name":"Session 4-6 - RWE international collaboration and next steps (Melissa Kampman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:52:00Z","last_updated_date":"2022-12-13T10:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-6-rwe-international-collaboration-and-next-steps-melissa-kampman_en.pdf"},
    {"id":"56963","name":"Session 4-7 - Advanced analytics to support animal and public health - Report from the 2nd Veterinary Big Data Stakeholders Forum (Ilaria Del Seppia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:55:00Z","last_updated_date":"2022-12-13T10:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-4-7-advanced-analytics-support-animal-and-public-health-report-2nd-veterinary-big-data-stakeholders-forum-ilaria-del-seppia_en.pdf"},
    {"id":"56964","name":"Session 5-1 - EU Research & Innovation activities (Christina Kyriakopoulou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T10:58:00Z","last_updated_date":"2022-12-13T10:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-5-1-eu-research-innovation-activities-christina-kyriakopoulou_en.pdf"},
    {"id":"56965","name":"Session 5-2 - Preparing for the future horizon scanning for big data topics (Ralf Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:00:00Z","last_updated_date":"2022-12-13T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/session-5-2-preparing-future-horizon-scanning-big-data-topics-ralf-herold_en.pdf"},
    {"id":"56966","name":"Presentation 1a - Update on electronic submissions & DADI- (K. Hamilton, K. Puusaar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:43:00Z","last_updated_date":"2022-12-13T11:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-1a-update-electronic-submissions-dadi-k-hamilton-k-puusaar_en.pdf"},
    {"id":"56967","name":"Presentation 2b - EMA International collaboration in the review of medicines (V. Palmi-Reig, M. Harvey-Allchurch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:46:00Z","last_updated_date":"2022-12-13T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2b-ema-international-collaboration-review-medicines-v-palmi-reig-m-harvey-allchurch_en.pdf"},
    {"id":"56968","name":"Presentation 3b - Pre-submissions meetings (M. Kollb-Sielecka, G. Bec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:46:00Z","last_updated_date":"2022-12-13T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-3b-pre-submissions-meetings-m-kollb-sielecka-g-bec_en.pdf"},
    {"id":"56973","name":"Presentation 6 - EMA's Clinical Trials Raw Data project (E. Psarelli & F. Lasch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:46:00Z","last_updated_date":"2022-12-13T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-6-emas-clinical-trials-raw-data-project-e-psarelli-f-lasch_en.pdf"},
    {"id":"56974","name":"Presentation 4a - Network sustainability and update on CHMP AR revamp project (F. Day)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:46:00Z","last_updated_date":"2022-12-13T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-4a-network-sustainability-and-update-chmp-ar-revamp-project-f-day_en.pdf"},
    {"id":"56975","name":"Presentation 7b - ePI - Update on Electronic Product Information (J. Garcia, E. Scanlan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:46:00Z","last_updated_date":"2022-12-13T11:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-7b-epi-update-electronic-product-information-j-garcia-e-scanlan_en.pdf"},
    {"id":"56978","name":"Programme - eXtended EudraVigilance Medicinal Product Dictionary live virtual training course for sponsors - February, May 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T14:23:00Z","last_updated_date":"2022-12-15T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/programme-extended-eudravigilance-medicinal-product-dictionary-live-virtual-training-course-sponsors-february-may-2023_en.pdf"},
    {"id":"56980","name":"Meeting highlights - Second European Medicines Agency and Affordable Medicines Europe bilateral meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T15:15:00Z","last_updated_date":"2022-12-13T15:15:00Z","reference_number":"EMA/88147/2022","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-highlights-second-european-medicines-agency-and-affordable-medicines-europe-bilateral-meeting_en.pdf"},
    {"id":"56982","name":"Withdrawal assessment report for Tuznue","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-12-13T15:29:00Z","last_updated_date":"2022-12-13T15:29:00Z","reference_number":"EMA/CHMP/902445/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tuznue_en.pdf"},
    {"id":"56983","name":"Withdrawal assessment report for Hervelous","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-12-13T15:37:00Z","last_updated_date":"2022-12-13T15:37:00Z","reference_number":"EMA/CHMP/915668/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-hervelous_en.pdf"},
    {"id":"56984","name":"Programme - Clinical Trials Information System (CTIS) sponsor end user training programme (Feb, May, June 2023)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T16:15:00Z","last_updated_date":"2022-12-13T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-clinical-trials-information-system-ctis-sponsor-end-user-training-programme-feb-may-june-2023_en.pdf"},
    {"id":"56985","name":"Agenda and registration form - Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual hands-on training course using the EudraVigilance system","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T16:16:00Z","last_updated_date":"2022-12-13T16:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-and-registration-form-mandatory-use-isoich-e2br3-individual-case-safety-reporting-eu-virtual-hands-training-course-using-eudravigilance-system_en.pdf"},
    {"id":"56987","name":"Liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-12-16T10:00:00Z","last_updated_date":"2022-12-16T10:00:00Z","reference_number":"EMA/CHMP/559889/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/liposomal-amphotericin-b-powder-dispersion-infusion-50-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"56988","name":"Lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg productspecific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2022-12-16T10:00:00Z","last_updated_date":"2022-12-16T10:00:00Z","reference_number":"EMA/CHMP/559891/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lanreotide-acetate-prolonged-release-solution-injection-prefilled-syringe-60-90-and-120-mg-productspecific-bioequivalence-guidance_en.pdf"},
    {"id":"56989","name":"Overview of comments on 'Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T17:18:00Z","last_updated_date":"2022-12-16T17:18:00Z","reference_number":"EMA/CHMP/839131/2022","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-draft-lanreotide-acetate-prolonged-release-solution-injection-prefilled-syringe-60-90-and-120-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"56994","name":"Questions and answers on the withdrawal for the marketing authorisation of Imbarkyd (bardoxolone)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T11:34:00Z","last_updated_date":"2023-02-07T12:34:00Z","reference_number":"EMA/913652/2022","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-marketing-authorisation-imbarkyd-bardoxolone_sv.pdf"}},
    {"id":"56995","name":"Withdrawal letter: Imbarkyd","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T11:36:00Z","last_updated_date":"2022-12-16T11:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-imbarkyd_en.pdf"},
    {"id":"57002","name":"Dengue Tetravalent Vaccine (Live, Attenuated) Takeda : Medicine Overview","type":"outside-EU-summary","status":"unknown","consultation_date":"","first_published_date":"2022-12-14T12:50:00Z","last_updated_date":"2022-12-14T12:50:00Z","reference_number":"EMA/844704/2022","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-summary/dengue-tetravalent-vaccine-live-attenuated-takeda-medicine-overview_en.pdf"},
    {"id":"57006","name":"Dengue Tetravalent Vaccine (Live, Attenuated) Takeda : Public assessment report","type":"outside-EU-assessment-report","status":"Adopted","consultation_date":"","first_published_date":"2022-12-14T13:00:00Z","last_updated_date":"2022-12-14T13:00:00Z","reference_number":"EMA/862556/2022","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-assessment-report/dengue-tetravalent-vaccine-live-attenuated-takeda-public-assessment-report_en.pdf"},
    {"id":"57009","name":"Agenda - Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-14T14:20:00Z","last_updated_date":"2022-12-14T14:20:00Z","reference_number":"EMA/601355/2021","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-ema-fda-workshop-efficacy-monoclonal-antibodies-context-rapidly-evolving-sars-cov-2-variants_en.pdf"},
    {"id":"57010","name":"Nomegestrol and chlormadinone Article-31 referral - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-12-14T13:46:00Z","last_updated_date":"2022-12-14T13:46:00Z","reference_number":"EMA/773938/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/nomegestrol-and-chlormadinone-article-31-referral-assessment-report_en.pdf"},
    {"id":"57011","name":"Agenda for the 118th meeting of the Management Board: 14-15 December 2022","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2022-12-14T14:50:00Z","last_updated_date":"2022-12-15T10:14:00Z","reference_number":"EMA/MB/817029/20222","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-118th-meeting-management-board-14-15-december-2022_en.pdf"},
    {"id":"57012","name":"Agenda - Human Variations eAF Form training session","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-14T15:25:00Z","last_updated_date":"2022-12-14T15:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-human-variations-eaf-form-training-session_en.pdf"},
    {"id":"57013","name":"Big Data highlights - Issue 4","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2022-12-14T16:14:00Z","last_updated_date":"2022-12-14T16:14:00Z","reference_number":"Issue 4","document_url":"https://www.ema.europa.eu/en/documents/newsletter/big-data-highlights-issue-4_en.pdf"},
    {"id":"57018","name":"Public statement on IntronA : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-12-14T16:56:00Z","last_updated_date":"2022-12-14T16:56:00Z","reference_number":"EMA/935216/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-introna-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"57045","name":"Agenda - Ninth industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T15:51:00Z","last_updated_date":"2022-12-15T15:51:00Z","reference_number":"EMA/832164/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ninth-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"57046","name":"Presentation - Recent developments to address scientific advice capacity and scope (Iordanis Gravanis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T15:53:00Z","last_updated_date":"2022-12-15T15:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recent-developments-address-scientific-advice-capacity-and-scope-iordanis-gravanis_en.pdf"},
    {"id":"57047","name":"Presentation - Focus Group on review and strengthening the framework for Qualification of Novel Methodologies (QoNM) (Thorsten Vetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T15:56:00Z","last_updated_date":"2022-12-15T15:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-review-and-strengthening-framework-qualification-novel-methodologies-qonm-thorsten-vetter_en.pdf"},
    {"id":"57048","name":"Presentation - Progressing parallel Joint Scientific Consultations (Antje Behring, Thorsten Olski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T15:58:00Z","last_updated_date":"2022-12-15T15:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-progressing-parallel-joint-scientific-consultations-antje-behring-thorsten-olski_en.pdf"},
    {"id":"57049","name":"Presentation - PRIME Implementation of recommendations based on first 5 years’ experience with the scheme (Kevin Cunningham)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T16:00:00Z","last_updated_date":"2022-12-15T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prime-implementation-recommendations-based-first-5-years-experience-scheme-kevin-cunningham_en.pdf"},
    {"id":"57050","name":"Presentation - EMA/EC action plan on paediatrics 2018-2022 (Gunter Egger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T16:02:00Z","last_updated_date":"2022-12-15T16:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emaec-action-plan-paediatrics-2018-2022-gunter-egger_en.pdf"},
    {"id":"57051","name":"Presentation - Closing report from the Focus group on the practical application of principles relevant for the PIP framework (Chrissi Pallidis, Sabine Scherer, Gesine Bejeuhr, Marcello Milano)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T16:04:00Z","last_updated_date":"2022-12-15T16:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-closing-report-focus-group-practical-application-principles-relevant-pip-framework-chrissi-pallidis-sabine-scherer-gesine-bejeuhr-marcello-milano_en.pdf"},
    {"id":"57052","name":"Presentation - Changes to the preparation of the Paediatric Annual Report to the EC (Isabel Sanchez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T16:06:00Z","last_updated_date":"2022-12-15T16:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-changes-preparation-paediatric-annual-report-ec-isabel-sanchez_en.pdf"},
    {"id":"57055","name":"Presentation - Follow-up on strengthening patient-centric development (Juan Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T16:10:00Z","last_updated_date":"2022-12-15T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-follow-strengthening-patient-centric-development-juan-garcia-burgos_en.pdf"},
    {"id":"57056","name":"Presentation - Human Variations eAF Form training session","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T16:22:00Z","last_updated_date":"2022-12-15T16:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-human-variations-eaf-form-training-session_en.pdf"},
    {"id":"57058","name":"Questions and answers on the refusal of a change to the marketing authorisation for Omblastys (omburtamab (131I))","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-12-16T17:15:00Z","last_updated_date":"2023-06-14T12:18:00Z","reference_number":"EMA/900390/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-and-answers-refusal-change-marketing-authorisation-omblastys-omburtamab-131i_sv.pdf"}},
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    {"id":"57060","name":"Rambis  Article 29(4) referral - EMA recommends authorisation of Rambis (ramipril / bisoprolol) in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T18:03:00Z","last_updated_date":"2022-12-16T18:03:00Z","reference_number":"EMA/940509/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/rambis-article-294-referral-ema-recommends-authorisation-rambis-ramipril-bisoprolol-eu_en.pdf"},
    {"id":"57061","name":"Rambis Article 29(4) referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T18:06:00Z","last_updated_date":"2022-12-16T18:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/rambis-article-294-referral-annex-iii_en.pdf"},
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    {"id":"57067","name":"CHMP post-authorisation summary of positive opinion for Imfinzi (II-41)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-12-16T10:22:00Z","last_updated_date":"2022-12-16T10:22:00Z","reference_number":"EMA/CHMP/925959/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imfinzi-ii-41_en.pdf"},
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    {"id":"57071","name":"CHMP post-authorisation summary of positive opinion for Adcirca (II-58-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-12-16T10:35:00Z","last_updated_date":"2022-12-16T10:35:00Z","reference_number":"EMA/CHMP/929228/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adcirca-ii-58-g_en.pdf"},
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    {"id":"57078","name":"Questions and answers on the ‘Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products'","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T12:22:00Z","last_updated_date":"2022-12-16T12:22:00Z","reference_number":"EMA/CVMP/EWP/799840/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-and-answers-guideline-summary-product-characteristics-antiparasitic-veterinary-medicinal-products_en.pdf"},
    {"id":"57079","name":"Overview of comments received on Draft Qualification Opinion of the iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating novel immunosuppressive medicines in kidney transplant patients","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T12:55:00Z","last_updated_date":"2022-12-16T12:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-qualification-opinion-ibox-scoring-system-secondary-efficacy-endpoint-clinical-trials-investigating-novel-immunosuppressive-medicines-kidney-transplant-patients_en.pdf"},
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    {"id":"57092","name":"Recommended due dates for submission of annual statements for centrally and non-centrally authorised products (CAPs and non-CAPs) to end 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-02-07T11:07:00Z","last_updated_date":"2023-02-07T11:07:00Z","reference_number":"EMA/58848/2023","document_url":"https://www.ema.europa.eu/en/documents/other/recommended-due-dates-submission-annual-statements-centrally-and-non-centrally-authorised-products-caps-and-non-caps-end-2023_en.xlsx"},
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    {"id":"57095","name":"Letter of Support of model-based clinical trial simulation platform (CTSP) for Duchenne Muscular Dystrophy","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T15:36:00Z","last_updated_date":"2022-12-16T15:36:00Z","reference_number":"EMADOC-1700519818-955047","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-model-based-clinical-trial-simulation-platform-ctsp-duchenne-muscular-dystrophy_en.pdf"},
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    {"id":"57107","name":"Presentation 5 - Update on Type II validation team (F. Day, L. Liebers, A. Begic, C. Forster)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2022-12-21T11:35:00Z","last_updated_date":"2022-12-21T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-5-update-type-ii-validation-team-f-day-l-liebers-begic-c-forster_en.pdf"},
    {"id":"57110","name":"Highlights from the ninth meeting of the Nitrosamine Implementation Oversight Group (NIOG)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-21T14:47:00Z","last_updated_date":"2022-12-21T14:47:00Z","reference_number":"EMA/INS/GMP/907821/2022","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-ninth-meeting-nitrosamine-implementation-oversight-group-niog_en.pdf"},
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    {"id":"57156","name":"Fexofenadine - List of nationally authorised medicinal products - PSUSA/00001388/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-01-04T17:14:00Z","last_updated_date":"2023-01-04T17:14:00Z","reference_number":"EMA/2586/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/fexofenadine-list-nationally-authorised-medicinal-products-psusa00001388202203_en.pdf"},
    {"id":"57157","name":"Fexofenadine - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00001388/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-01-04T17:18:00Z","last_updated_date":"2023-01-04T17:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_sv.pdf","is":"https://www.ema.europa.eu/is/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_is.pdf","no":"https://www.ema.europa.eu/no/documents/psusa/fexofenadine-scientific-conclusions-and-grounds-variation-terms-marketing-authorisation-psusa00001388202203_no.pdf"}},
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    {"id":"57169","name":"Consolidated 3-year work plan for the Rheumatology and Immunology Working Party (RIWP)","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2023-01-05T15:38:00Z","last_updated_date":"2023-01-05T15:38:00Z","reference_number":"EMA/CHMP/946000/2022","document_url":"https://www.ema.europa.eu/en/documents/work-programme/consolidated-3-year-work-plan-rheumatology-and-immunology-working-party-riwp_en.pdf"},
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    {"id":"57172","name":"ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-01-06T15:04:00Z","last_updated_date":"2023-01-06T15:04:00Z","reference_number":"EMA/CHMP/ICH/427817/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q13-continuous-manufacturing-drug-substances-and-drug-products-step-5_en.pdf"},
    {"id":"57174","name":"European Medicines Agency budget for 2023","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2023-01-09T08:50:00Z","last_updated_date":"2023-01-09T08:50:00Z","reference_number":"EMA/MB/914861/2022","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-budget-2023_en.pdf"},
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    {"id":"57219","name":"Highlight report - Ninth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-01-11T14:24:00Z","last_updated_date":"2023-01-11T14:24:00Z","reference_number":"EMA/907045/2022","document_url":"https://www.ema.europa.eu/en/documents/report/highlight-report-ninth-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicines_en.pdf"},
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    {"id":"57230","name":"News bulletin for small and medium-sized enterprises - Issue 57","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T09:37:00Z","last_updated_date":"2023-01-12T09:37:00Z","reference_number":"Issue 57","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-57_en.pdf"},
    {"id":"57233","name":"Presentation 01. SARS-CoV-2 Monoclonal Antibody Workshop: FDA Perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:24:00Z","last_updated_date":"2023-01-12T10:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-01-sars-cov-2-monoclonal-antibody-workshop-fda-perspective_en.pdf"},
    {"id":"57234","name":"Presentation 01a. SARS-CoV-2 Monoclonal Antibody Workshop: EMA Perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:27:00Z","last_updated_date":"2023-01-12T10:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-01a-sars-cov-2-monoclonal-antibody-workshop-ema-perspective_en.pdf"},
    {"id":"57235","name":"Presentation 02. Overview of the clinical trials that led to the authorisation of monoclonal antibody therapies in the EU","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:28:00Z","last_updated_date":"2023-01-12T10:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-02-overview-clinical-trials-led-authorisation-monoclonal-antibody-therapies-eu_en.pdf"},
    {"id":"57236","name":"Presentation 03. Viral diversity and antibody breadth","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:31:00Z","last_updated_date":"2023-01-12T10:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-03-viral-diversity-and-antibody-breadth_en.pdf"},
    {"id":"57237","name":"Presentation 04. Utility of virologic assessments as a marker of progression to severe disease based on data from the ACTIV-2 trial","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:34:00Z","last_updated_date":"2023-01-12T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-04-utility-virologic-assessments-marker-progression-severe-disease-based-data-activ-2-trial_en.pdf"},
    {"id":"57238","name":"Presentation 05. Translational PK-PD Modeling During COVID-19_Evusheld and Points to Consider","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:35:00Z","last_updated_date":"2023-01-12T10:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-05-translational-pk-pd-modeling-during-covid-19_evusheld-and-points-consider_en.pdf"},
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    {"id":"57240","name":"06. Evidence in support of the use of serum neutralization data to justify a dose increase of monoclonal antibodies to tackle new variant","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:38:00Z","last_updated_date":"2023-01-12T10:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/06-evidence-support-use-serum-neutralization-data-justify-dose-increase-monoclonal-antibodies-tackle-new-variant_en.pdf"},
    {"id":"57241","name":"Presentation 07. Lessons on Correlates of Protection from COVID-19 Vaccines and HIV-1 Monoclonal Antibodies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:46:00Z","last_updated_date":"2023-01-12T10:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-07-lessons-correlates-protection-covid-19-vaccines-and-hiv-1-monoclonal-antibodies_en.pdf"},
    {"id":"57242","name":"Presentation 08. Correlation Between Protection and ex vivo Neutralization in the Context of Pre-exposure Prophylaxis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:51:00Z","last_updated_date":"2023-01-12T10:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-08-correlation-between-protection-and-ex-vivo-neutralization-context-pre-exposure-prophylaxis_en.pdf"},
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    {"id":"57244","name":"Presentation 10. Considerations Regarding Assessment of a Modified Monoclonal Antibody (mAb) Product Related to a Prototype mAb Production Addressing Emerging SARS-COV-2 Variants– a CMC Perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:55:00Z","last_updated_date":"2023-01-12T10:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-10-considerations-regarding-assessment-modified-monoclonal-antibody-mab-product-related-prototype-mab-production-addressing-emerging-sars-cov-2-variants-cmc-perspective_en.pdf"},
    {"id":"57245","name":"Presentation 11. Development Approach for Anti-Spike Monoclonal Antibodies to Keep Pace with SARS-CoV-2 Variants","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T10:58:00Z","last_updated_date":"2023-01-12T10:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11-development-approach-anti-spike-monoclonal-antibodies-keep-pace-sars-cov-2-variants_en.pdf"},
    {"id":"57246","name":"Presentation 11a. Use of neutralizing antibody or PK_IC50 threshold to expedite clinical development for prophylactic monoclonal antibodies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T11:00:00Z","last_updated_date":"2023-01-12T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11a-use-neutralizing-antibody-or-pk_ic50-threshold-expedite-clinical-development-prophylactic-monoclonal-antibodies_en.pdf"},
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    {"id":"57248","name":"Presentation 11c. QSP Strategy to Support Development of Adintrevimab for Prevention and Treatment of COVID-19","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T11:06:00Z","last_updated_date":"2023-01-12T11:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11c-qsp-strategy-support-development-adintrevimab-prevention-and-treatment-covid-19_en.pdf"},
    {"id":"57249","name":"Presentation 11d. Molecules Against Novel Targets","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-12T11:09:00Z","last_updated_date":"2023-01-12T11:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-11d-molecules-against-novel-targets_en.pdf"},
    {"id":"57267","name":"CHMP PROM agenda for the meeting on 3 October 2022","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-01-12T15:18:00Z","last_updated_date":"2023-01-12T15:18:00Z","reference_number":"EMA/CHMP/770426/2022 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-3-october-2022_en.pdf"},
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    {"id":"57395","name":"Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T09:00:00Z","last_updated_date":"2023-01-31T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-lymphoseek-tilmanocept-50-micrograms-kit-radiopharmaceutical-preparation-temporary-extension-shelf-life_en.pdf-0"},
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    {"id":"57405","name":"Letter of Support for Braintale platforms","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-01-26T14:38:00Z","last_updated_date":"2023-01-26T14:38:00Z","reference_number":"EMADOC-1700519818-982447","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-braintale-platforms_en.pdf"},
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    {"id":"57422","name":"Adakveo Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-01-27T10:15:00Z","last_updated_date":"2023-01-27T10:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/adakveo-article-20-procedure-notification_en.pdf"},
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    {"id":"57427","name":"Scientific advice and protocol assistance Adopted during the CHMP meeting 23-26 January 2023","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2023-01-27T11:09:00Z","last_updated_date":"2023-01-27T11:09:00Z","reference_number":"EMA/CHMP/SAWP/41275/2023","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-23-26-january-2023_en.pdf"},
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    {"id":"57432","name":"Overview of comments received on the ‘Reflection paper on resistance in ectoparasites’ (EMA/CVMP/EWP/310225/2014)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2023-01-27T11:43:00Z","last_updated_date":"2023-01-27T11:43:00Z","reference_number":"EMA/CVMP/EWP/483154/2019","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-resistance-ectoparasites-emacvmpewp3102252014_en.pdf"},
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    {"id":"57434","name":"Start of Union reviews adopted during the CHMP meeting of 23-26 January 2023","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2023-01-27T11:48:00Z","last_updated_date":"2023-01-27T11:48:00Z","reference_number":"EMA/29414/2023","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-union-reviews-adopted-during-chmp-meeting-23-26-january-2023_en.pdf"},
    {"id":"57436","name":"Question and answer document on the Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products (EMA/CVMP/SWP/377245/2016)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-01-27T12:15:00Z","last_updated_date":"2023-01-27T12:15:00Z","reference_number":"EMA/CVMP/SWP/32272/2022","document_url":"https://www.ema.europa.eu/en/documents/other/question-and-answer-document-guideline-assessment-and-control-dna-reactive-mutagenic-impurities-veterinary-medicinal-products-emacvmpswp3772452016_en.pdf"},
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    {"id":"57440","name":"CTTM03 - Step-by-step guide (Create organisations locally in CTIS)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-01-27T16:44:00Z","last_updated_date":"2023-01-27T16:44:00Z","reference_number":"Version 1 – January 2023","document_url":"https://www.ema.europa.eu/en/documents/other/cttm03-step-step-guide-create-organisations-locally-ctis_en.pdf"},
    {"id":"57442","name":"Withdrawal assessment report for Febseltiq","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-01-30T10:15:00Z","last_updated_date":"2023-01-30T10:15:00Z","reference_number":"EMA/939316/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-febseltiq_en.pdf"},
    {"id":"57446","name":"CHMP PROM agenda for the meeting on 5 December 2022","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-01-30T12:16:00Z","last_updated_date":"2023-01-30T12:16:00Z","reference_number":"EMA/CHMP/878170/2022 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-5-december-2022_en.pdf"},
    {"id":"57449","name":"Bleomycin : List of nationally authorised medicinal products - PSUSA/00000422/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-01-30T14:06:00Z","last_updated_date":"2023-01-30T14:06:00Z","reference_number":"EMA/48042/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/bleomycin-list-nationally-authorised-medicinal-products-psusa00000422202203_en.pdf"},
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    {"id":"57451","name":"Presentation - Global overview of vaccine related myocarditis (Kristine Macartney)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:23:00Z","last_updated_date":"2023-01-31T17:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-global-overview-vaccine-related-myocarditis-kristine-macartney_en.pdf"},
    {"id":"57452","name":"Presentation - Risk of myocarditis after Covid-19 mRNA vaccination: Impact of booster dose and dosing interval (Le Vu et al.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:26:00Z","last_updated_date":"2023-01-31T17:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-myocarditis-after-covid-19-mrna-vaccination-impact-booster-dose-and-dosing-interval-le-vu-et-al_en.pdf"},
    {"id":"57453","name":"Presentation - Incidence, follow-up, and pathophysiology of myocarditis following mRNA vaccine in Israel: Results of an active surveillance (Mevorach)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:36:00Z","last_updated_date":"2023-01-31T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-incidence-follow-and-pathophysiology-myocarditis-following-mrna-vaccine-israel-results-active-surveillance-mevorach_en.pdf"},
    {"id":"57455","name":"Presentation - COVID-19 Vaccine BNT162b2 myocarditis (Pfizer / BioNTech)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:42:00Z","last_updated_date":"2023-01-31T17:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-covid-19-vaccine-bnt162b2-myocarditis-pfizer-biontech_en.pdf"},
    {"id":"57456","name":"Presentation - Moderna COVID-19 vaccines and the risk of myocarditis: review of current data and planned studies (Walter Straus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:45:00Z","last_updated_date":"2023-01-31T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-moderna-covid-19-vaccines-and-risk-myocarditis-review-current-data-and-planned-studies-walter-straus_en.pdf"},
    {"id":"57457","name":"Presentation - Myocarditis post-marketing reporting rates for Nuvaxovid (Christopher Mast)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:54:00Z","last_updated_date":"2023-01-31T17:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-myocarditis-post-marketing-reporting-rates-nuvaxovid-christopher-mast_en.pdf"},
    {"id":"57458","name":"Presentation - Integrated analysis of transcriptomic and epigenomic signatures of peripheral immune cells in the patient of BNT162b2-induced myocarditis (Bo Kyung Yoon, M.D.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:58:00Z","last_updated_date":"2023-01-31T17:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-integrated-analysis-transcriptomic-and-epigenomic-signatures-peripheral-immune-cells-patient-bnt162b2-induced-myocarditis-bo-kyung-yoon-md_en.pdf"},
    {"id":"57459","name":"Presentation - Circulating spike protein detected in post-COVID-19 mRNA vaccine myocarditis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:01:00Z","last_updated_date":"2023-01-31T18:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-circulating-spike-protein-detected-post-covid-19-mrna-vaccine-myocarditis_en.pdf"},
    {"id":"57460","name":"Presentation - Circulating spike protein detected in post-COVID-19 mRNA vaccine myocarditis (Lael M. Yonker et al.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:01:00Z","last_updated_date":"2023-01-31T18:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-circulating-spike-protein-detected-post-covid-19-mrna-vaccine-myocarditis-lael-m-yonker-et-al_en.pdf"},
    {"id":"57461","name":"Presentation - Implication of sex differences in myocarditis (Katelyn Bruno)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:06:00Z","last_updated_date":"2023-01-31T18:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implication-sex-differences-myocarditis-katelyn-bruno_en.pdf"},
    {"id":"57462","name":"Presentation - Innate immune mechanisms of mRNA vaccines (Rein Verbeke et al.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:09:00Z","last_updated_date":"2023-01-31T18:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-innate-immune-mechanisms-mrna-vaccines-rein-verbeke-et-al_en.pdf"},
    {"id":"57463","name":"Presentation - IL-RA antibodies in myocarditis after SARS-CoV-2 vaccination (Thurner L et al.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:14:00Z","last_updated_date":"2023-01-31T18:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-il-ra-antibodies-myocarditis-after-sars-cov-2-vaccination-thurner-l-et-al_en.pdf"},
    {"id":"57464","name":"Presentation - Lack of evidence of significant homology of SARS-CoV-2 spike sequences to myocarditis-associated antigens (Alessandro Sette)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:16:00Z","last_updated_date":"2023-01-31T18:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lack-evidence-significant-homology-sars-cov-2-spike-sequences-myocarditis-associated-antigens-alessandro-sette_en.pdf"},
    {"id":"57465","name":"Presentation - Mechanisms of myocarditis post-COVID vaccination (Alida LP Caforio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:18:00Z","last_updated_date":"2023-01-31T18:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mechanisms-myocarditis-post-covid-vaccination-alida-lp-caforio_en.pdf"},
    {"id":"57466","name":"Presentation - SARS CoV 2 vaccination autopsies (Peter Schirmacher)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:21:00Z","last_updated_date":"2023-01-31T18:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sars-cov-2-vaccination-autopsies-peter-schirmacher_en.pdf"},
    {"id":"57467","name":"Presentation - Genetic study of vaccine-induced myocarditis (Alexandre Bolze, Elena Hsieh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T18:23:00Z","last_updated_date":"2023-01-31T18:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-genetic-study-vaccine-induced-myocarditis-alexandre-bolze-elena-hsieh_en.pdf"},
    {"id":"57468","name":"Agenda - EMA virtual workshop on myocarditis post COVID-19 vaccination","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T14:00:00Z","last_updated_date":"2023-01-31T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-virtual-workshop-myocarditis-post-covid-19-vaccination_en.pdf"},
    {"id":"57469","name":"Final programming document 2023-2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T09:58:00Z","last_updated_date":"2023-01-31T09:58:00Z","reference_number":"EMA/36710/2023","document_url":"https://www.ema.europa.eu/en/documents/report/final-programming-document-2023-2025_en.pdf"},
    {"id":"57472","name":"Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2023","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T11:48:00Z","last_updated_date":"2023-01-31T11:48:00Z","reference_number":"EMA/CHMP/CVMP/QWP/822156/2022","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-joint-chmp-cvmp-quality-working-party-qwp-2023_en.pdf"},
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    {"id":"57542","name":"COMP work plan 2023","type":"work-programme","status":"Adopted","consultation_date":"","first_published_date":"2023-02-07T15:31:00Z","last_updated_date":"2023-02-07T15:31:00Z","reference_number":"EMA/COMP/48038/2023","document_url":"https://www.ema.europa.eu/en/documents/work-programme/comp-work-plan-2023_en.pdf"},
    {"id":"57544","name":"Agenda - Fourth meeting of the Nitrosamine Implementation Oversight Group - Industry Associations","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-02-07T15:59:00Z","last_updated_date":"2023-02-07T15:59:00Z","reference_number":"EMA/735648/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fourth-meeting-nitrosamine-implementation-oversight-group-industry-associations_en.pdf"},
    {"id":"57545","name":"Highlights from the fourth meeting of the Nitrosamine Implementation Oversight Group (NIOG) and pharmaceutical Industry","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-02-07T14:16:00Z","last_updated_date":"2023-02-07T14:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-fourth-meeting-nitrosamine-implementation-oversight-group-niog-and-pharmaceutical-industry_en.pdf"},
    {"id":"57546","name":"Presentation - Fourth meeting of the Nitrosamine Implementation Oversight Group (NIOG) and pharmaceutical Industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-07T14:16:00Z","last_updated_date":"2023-02-07T14:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fourth-meeting-nitrosamine-implementation-oversight-group-niog-and-pharmaceutical-industry_en.pdf"},
    {"id":"57547","name":"Industry presentation - Fourth meeting of the Nitrosamine Implementation Oversight Group (NIOG) and pharmaceutical Industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-07T14:16:00Z","last_updated_date":"2023-02-07T14:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/industry-presentation-fourth-meeting-nitrosamine-implementation-oversight-group-niog-and-pharmaceutical-industry_en.pdf"},
    {"id":"57548","name":"Direct healthcare professional communication (DHPC) : Amfepramone-containing medicines will no longer be available on the EU market, as marketing authorisations will be revoked","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T09:00:00Z","last_updated_date":"2023-02-08T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-amfepramone-containing-medicines-will-no-longer-be-available-eu-market-marketing-authorisations-will-be-revoked_en.pdf"},
    {"id":"57549","name":"Industry presentation (2) - Fourth meeting of the Nitrosamine Implementation Oversight Group (NIOG) and pharmaceutical Industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-07T14:16:00Z","last_updated_date":"2023-02-07T14:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/industry-presentation-2-fourth-meeting-nitrosamine-implementation-oversight-group-niog-and-pharmaceutical-industry_en.pdf"},
    {"id":"57553","name":"Presentation - State of the Art of RNA Technologies_EU regulators’ perspective (Sol Ruiz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:33:00Z","last_updated_date":"2023-02-08T10:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-state-art-rna-technologies_eu-regulators-perspective-sol-ruiz_en.pdf"},
    {"id":"57554","name":"Withdrawal assessment report for Miplyffa","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-02-07T12:34:00Z","last_updated_date":"2023-02-07T12:34:00Z","reference_number":"EMA/177363/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-miplyffa_en.pdf"},
    {"id":"57555","name":"Agenda - Fifth EMA-EFPIA annual bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:40:00Z","last_updated_date":"2023-02-08T10:40:00Z","reference_number":"EMA/47787/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fifth-ema-efpia-annual-bilateral-meeting_en.pdf"},
    {"id":"57556","name":"Presentation - A brief introduction into oligonucleotide therapies (Annemieke Aartsma-Rus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:40:00Z","last_updated_date":"2023-02-08T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-brief-introduction-oligonucleotide-therapies-annemieke-aartsma-rus_en.pdf"},
    {"id":"57557","name":"Presentation - State of the Art of RNA Technologies \"Industry Perspective\" (Tal Zaks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:44:00Z","last_updated_date":"2023-02-08T10:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-state-art-rna-technologies-industry-perspective-tal-zaks_en.pdf"},
    {"id":"57558","name":"Presentation - EU Regulators’ experience with synthetic oligonucleotides and mRNA technology (René Thürmer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:50:00Z","last_updated_date":"2023-02-08T10:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-regulators-experience-synthetic-oligonucleotides-and-mrna-technology-rene-thurmer_en.pdf"},
    {"id":"57559","name":"Presentation - Industry perspective on synthetic oligonucleotide (Daniel Capaldi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:52:00Z","last_updated_date":"2023-02-08T10:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-synthetic-oligonucleotide-daniel-capaldi_en.pdf"},
    {"id":"57560","name":"Presentation - Industry perspective on mRNA technology (Pawel Widomski)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T10:56:00Z","last_updated_date":"2023-02-08T10:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-mrna-technology-pawel-widomski_en.pdf"},
    {"id":"57561","name":"Presentation - Opportunities and challenges in non-clinical development - Academic Perspective (Haiyan Zhou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:02:00Z","last_updated_date":"2023-02-08T11:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-and-challenges-non-clinical-development-academic-perspective-haiyan-zhou_en.pdf"},
    {"id":"57562","name":"Presentation - Application of RNA Technologies Non-Clinical Industry perspective (Susan Goody)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:11:00Z","last_updated_date":"2023-02-08T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-application-rna-technologies-non-clinical-industry-perspective-susan-goody_en.pdf"},
    {"id":"57563","name":"Presentation - Opportunities and challenges in non-clinical development - The regulator's perspective (Camilla Svensson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:20:00Z","last_updated_date":"2023-02-08T11:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-and-challenges-non-clinical-development-regulators-perspective-camilla-svensson_en.pdf"},
    {"id":"57564","name":"Presentation - Applications of RNA technologies - Clinical_Academia perspective (David Henshall)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:26:00Z","last_updated_date":"2023-02-08T11:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-applications-rna-technologies-clinical_academia-perspective-david-henshall_en.pdf"},
    {"id":"57565","name":"Presentation - Applications of RNA technologies - Clinical - An Industry Perspective (Michael Wenger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:29:00Z","last_updated_date":"2023-02-08T11:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-applications-rna-technologies-clinical-industry-perspective-michael-wenger_en.pdf"},
    {"id":"57566","name":"Presentation - Applications of RNA technologies - Clinical - Regulators' perspective (Joop van Gerven)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:35:00Z","last_updated_date":"2023-02-08T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-applications-rna-technologies-clinical-regulators-perspective-joop-van-gerven_en.pdf"},
    {"id":"57567","name":"Speakers’ biography","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T11:37:00Z","last_updated_date":"2023-02-08T11:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/speakers-biography_en.pdf"},
    {"id":"57578","name":"Minutes - DARWIN EU Advisory Board meeting: 8 September 2022","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2023-02-08T15:41:00Z","last_updated_date":"2023-02-08T15:41:00Z","reference_number":"EMA/757688/2022","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-darwin-eu-advisory-board-meeting-8-september-2022_en.pdf"},
    {"id":"57579","name":"Agenda - DARWIN EU Advisory Board meeting: 6 February 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-02-08T15:48:00Z","last_updated_date":"2023-02-08T15:48:00Z","reference_number":"EMA/831618/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-darwin-eu-advisory-board-meeting-6-february-2023_en.pdf"},
    {"id":"57580","name":"Moclobemide : List of nationally authorised medicinal products - PSUSA/00002079/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-08T16:05:00Z","last_updated_date":"2023-02-08T16:05:00Z","reference_number":"EMA/382258/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/moclobemide-list-nationally-authorised-medicinal-products-psusa00002079202204_en.pdf"},
    {"id":"57583","name":"Note on European Medicines Agency’s involvement in HORIZON-HLTH-2023-TOOL-05-09: Developing a Data Quality and Utility Label for the European Health Data Space","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-02-09T11:41:00Z","last_updated_date":"2023-02-09T11:41:00Z","reference_number":"EMA/53514/2023","document_url":"https://www.ema.europa.eu/en/documents/other/note-european-medicines-agencys-involvement-horizon-hlth-2023-tool-05-09-developing-data-quality-and-utility-label-european-health-data-space_en.pdf"},
    {"id":"57584","name":"Acamprosate : List of nationally authorised medicinal products - PSUSA/00000016/202207","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-09T14:24:00Z","last_updated_date":"2023-02-09T14:24:00Z","reference_number":"EMA/65272/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/acamprosate-list-nationally-authorised-medicinal-products-psusa00000016202207_en.pdf"},
    {"id":"57588","name":"Amorolfine : List of nationally authorised medicinal products - PSUSA/00000185/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T09:06:00Z","last_updated_date":"2023-02-10T09:06:00Z","reference_number":"EMA/923657/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/amorolfine-list-nationally-authorised-medicinal-products-psusa00000185202206_en.pdf"},
    {"id":"57589","name":"Cilastatin / Imipenem : List of nationally authorised medicinal products - PSUSA/00000748/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T09:27:00Z","last_updated_date":"2023-02-10T09:27:00Z","reference_number":"EMA/923713/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/cilastatin-imipenem-list-nationally-authorised-medicinal-products-psusa00000748202206_en.pdf"},
    {"id":"57590","name":"Ganciclovir : List of nationally authorised medicinal products - PSUSA/00001516/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T09:33:00Z","last_updated_date":"2023-02-10T09:33:00Z","reference_number":"EMA/943452/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/ganciclovir-list-nationally-authorised-medicinal-products-psusa00001516202206_en.pdf"},
    {"id":"57591","name":"Pentamidine : List of nationally authorised medicinal products - PSUSA/00002338/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T09:37:00Z","last_updated_date":"2023-02-10T09:37:00Z","reference_number":"EMA/923642/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/pentamidine-list-nationally-authorised-medicinal-products-psusa00002338202206_en.pdf"},
    {"id":"57592","name":"Paediatric Addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T10:43:00Z","last_updated_date":"2023-02-10T10:43:00Z","reference_number":"EMA/CHMP/20507/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paediatric-addendum-guidelines-clinical-investigation-medicinal-products-treatment-and-prophylaxis-venous-thromboembolic-disease_en.pdf-0"},
    {"id":"57593","name":"Overview of comments received on draft Paediatric Addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease (EMA/CHMP/763438/2017)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T10:47:00Z","last_updated_date":"2023-02-10T10:47:00Z","reference_number":"EMA/CHMP/20512/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-draft-paediatric-addendum-guidelines-clinical-investigation-medicinal-products-treatment-and-prophylaxis-venous-thromboembolic-disease-emachmp7634382017_en.pdf"},
    {"id":"57595","name":"Pseudoephedrine-containing medicines Article-31 referral - PRAC List of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T11:45:00Z","last_updated_date":"2023-02-10T11:45:00Z","reference_number":"EMA/PRAC/55342/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/pseudoephedrine-containing-medicines-article-31-referral-prac-list-questions_en.pdf"},
    {"id":"57596","name":"Pseudoephedrine-containing medicines Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T11:47:00Z","last_updated_date":"2023-02-10T11:47:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pseudoephedrine-containing-medicines-article-31-referral-notification_en.pdf"},
    {"id":"57598","name":"Pseudoephedrine-containing medicines Article-31 referral - Annex A and Annex I","type":"referral","status":"Draft","consultation_date":"","first_published_date":"2023-02-10T11:49:00Z","last_updated_date":"2023-05-12T16:00:00Z","reference_number":"EMA/55341/2023 Rev. 1 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/referral/pseudoephedrine-containing-medicines-article-31-referral-annex-and-annex-i_en.pdf"},
    {"id":"57599","name":"Allergen for diagnostic and or therapy Vespula SPP. (802) (with or without adjuvant), Wasp venom - nationally authorised product only) - List of nationally authorised medicinal products - PSUSA/00010721/202207","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T11:48:00Z","last_updated_date":"2023-02-10T11:48:00Z","reference_number":"EMA/65819/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-diagnostic-and-or-therapy-vespula-spp-802-or-without-adjuvant-wasp-venom-nationally-authorised-product-only-list-nationally-authorised-medicinal-products-psusa00010721202207_en.pdf"},
    {"id":"57600","name":"PRAC statistics: April 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-04-14T12:16:00Z","last_updated_date":"2023-04-14T12:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-april-2023_en.pdf"},
    {"id":"57601","name":"Theophylline - List of nationally authorised medicinal products - PSUSA/00002921/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T12:28:00Z","last_updated_date":"2023-02-10T12:28:00Z","reference_number":"EMA/66072/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/theophylline-list-nationally-authorised-medicinal-products-psusa00002921202206_en.pdf"},
    {"id":"57602","name":"Methylaminolevulinate : List of nationally authorised medicinal products - PSUSA/00002019/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T12:42:00Z","last_updated_date":"2023-02-10T12:42:00Z","reference_number":"EMA/55954/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylaminolevulinate-list-nationally-authorised-medicinal-products-psusa00002019202206_en.pdf"},
    {"id":"57603","name":"Apis mellifera (801) (with or without adjuvant), Apis mellifera venom - List of nationally authorised medicinal products - PSUSA/00010722/202207","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T12:52:00Z","last_updated_date":"2023-02-10T12:52:00Z","reference_number":"EMA/66152/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/apis-mellifera-801-or-without-adjuvant-apis-mellifera-venom-list-nationally-authorised-medicinal-products-psusa00010722202207_en.pdf"},
    {"id":"57604","name":"Sulfamethizole - List of nationally authorised medicinal products - PSUSA/00010561/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T13:20:00Z","last_updated_date":"2023-02-10T13:20:00Z","reference_number":"EMA/915820/2022","document_url":"https://www.ema.europa.eu/en/documents/psusa/sulfamethizole-list-nationally-authorised-medicinal-products-psusa00010561202206_en.pdf"},
    {"id":"57605","name":"Withdrawal assessment report for Aliqopa","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-02-10T13:42:00Z","last_updated_date":"2023-02-10T13:42:00Z","reference_number":"EMA/948113/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-aliqopa_en.pdf"},
    {"id":"57606","name":"Nitrous oxide, nitrous oxide / oxygen - List of nationally authorised medicinal products - PSUSA/00010572/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T14:16:00Z","last_updated_date":"2023-02-10T14:16:00Z","reference_number":"EMA/67039/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/nitrous-oxide-nitrous-oxide-oxygen-list-nationally-authorised-medicinal-products-psusa00010572202206_en.pdf"},
    {"id":"57610","name":"Summary report - Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T15:48:00Z","last_updated_date":"2023-02-10T15:48:00Z","reference_number":"EMA/67738/2023","document_url":"https://www.ema.europa.eu/en/documents/report/summary-report-joint-ema-fda-workshop-efficacy-monoclonal-antibodies-context-rapidly-evolving-sars-cov-2-variants_en.pdf"},
    {"id":"57611","name":"Human coagulation factor XIII : List of nationally authorised medicinal products - PSUSA/00001622/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T15:49:00Z","last_updated_date":"2023-02-10T15:49:00Z","reference_number":"EMA/67648/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-coagulation-factor-xiii-list-nationally-authorised-medicinal-products-psusa00001622202206_en.pdf"},
    {"id":"57612","name":"Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/202203","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-10T15:56:00Z","last_updated_date":"2023-02-10T15:56:00Z","reference_number":"EMA/67667/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/germanium-68ge-chloride-gallium-68ga-chloride-list-nationally-authorised-medicinal-products-psusa00010364202203_en.pdf"},
    {"id":"57657","name":"Agenda of the CVMP meeting 14-16 February 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-02-13T16:46:00Z","last_updated_date":"2023-02-13T16:46:00Z","reference_number":"EMA/68188/2023 – draft 3","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-14-16-february-2023_en.pdf"},
    {"id":"57658","name":"Direct healthcare professional communication (DHPC) : Adakveo (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T09:45:00Z","last_updated_date":"2023-02-14T09:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-adakveo-crizanlizumab-phase-iii-study-cseg101a2301-shows-no-superiority-crizanlizumab-over-placebo_en.pdf"},
    {"id":"57660","name":"Ibuprofen / pseudoephedrine - List of nationally authorised medicinal products - PSUSA/00001711/202207","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T12:01:00Z","last_updated_date":"2023-02-14T12:01:00Z","reference_number":"EMA/71236/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/ibuprofen-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa00001711202207_en.pdf"},
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    {"id":"57675","name":"Veterinary Medicines Highlights 2022","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-02-16T10:46:00Z","last_updated_date":"2023-02-16T10:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/veterinary-medicines-highlights-2022_en.pdf"},
    {"id":"57677","name":"Addendum to Assessment report on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, flos","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-02-15T14:43:00Z","last_updated_date":"2023-02-15T14:43:00Z","reference_number":"EMA/HMPC/176303/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-flos_en.pdf"},
    {"id":"57684","name":"Work plan for the Biologics Working Party (BWP) for 2023","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2023-02-15T16:20:00Z","last_updated_date":"2023-02-15T16:20:00Z","reference_number":"EMA/CHMP/BWP/860809/2022","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-biologics-working-party-bwp-2023_en.pdf"},
    {"id":"57686","name":"Agenda - Product Management Service (PMS) Webinar on  Data Migration","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-02-15T17:39:00Z","last_updated_date":"2023-02-15T17:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-product-management-service-pms-webinar-data-migration_en.pdf"},
    {"id":"57694","name":"Draft European Union herbal monograph on Cnicus benedictus L., herba","type":"herbal-monograph","status":"Draft","consultation_date":"","first_published_date":"2023-02-16T13:09:00Z","last_updated_date":"2023-02-16T13:09:00Z","reference_number":"EMA/HMPC/32402/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-cnicus-benedictus-l-herba_en.pdf"},
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    {"id":"57696","name":"Draft list of references supporting the assessment of Cnicus benedictus L., herba","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2023-02-16T13:13:00Z","last_updated_date":"2023-02-16T13:13:00Z","reference_number":"EMA/HMPC/32403/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-cnicus-benedictus-l-herba_en.pdf"},
    {"id":"57697","name":"Considerations for research / project teams seeking competent authority participation in externally funded regulatory science and public health research projects related to medicinal products","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-02-20T10:15:00Z","last_updated_date":"2023-02-20T10:15:00Z","reference_number":"EMA/38599/2023","document_url":"https://www.ema.europa.eu/en/documents/other/considerations-research-project-teams-seeking-competent-authority-participation-externally-funded-regulatory-science-and-public-health-research-projects-related-medicinal-products_en.pdf"},
    {"id":"57698","name":"Direct healthcare professional communication (DHPC) : Neofordex 40 mg (dexamethasone): removal of the score-line and the associated 20 mg posology","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-17T15:31:00Z","last_updated_date":"2023-02-17T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-neofordex-40-mg-dexamethasone-removal-score-line-and-associated-20-mg-posology_en.pdf"},
    {"id":"57699","name":"Direct healthcare professional communications (DHPC) : Supply shortage of Fasturtec (rasburicase) 7.5 mg/5 ml powder and solvent for concentrate for solution for infusion (EU/1/00/170/002)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-17T09:46:00Z","last_updated_date":"2023-02-17T09:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communications-dhpc-supply-shortage-fasturtec-rasburicase-75-mg5-ml-powder-and-solvent-concentrate-solution-infusion-eu100170002_en.pdf"},
    {"id":"57700","name":"Flecainide - List of nationally authorised medicinal products - PSUSA/00001396/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-02-16T16:18:00Z","last_updated_date":"2023-02-16T16:18:00Z","reference_number":"EMA/76569/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/flecainide-list-nationally-authorised-medicinal-products-psusa00001396202206_en.pdf"},
    {"id":"57702","name":"Guideline on development pharmaceutics for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-02-17T11:10:00Z","last_updated_date":"2023-02-17T11:10:00Z","reference_number":"EMA/CVMP/QWP/684556/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-pharmaceutics-veterinary-medicinal-products_en.pdf"},
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    {"id":"57704","name":"Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of New Active Substance (NAS) status of chemical substances for veterinary medical products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-02-17T11:57:00Z","last_updated_date":"2023-02-17T11:57:00Z","reference_number":"EMA/CVMP/QWP/3629/2016-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-chemical-structure-and-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances-veterinary-medical-products_en.pdf"},
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    {"id":"57707","name":"CVMP summary of positive opinion for Bovilis Nasalgen-C","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-02-17T13:05:00Z","last_updated_date":"2023-02-17T13:05:00Z","reference_number":"EMA/CVMP/42050/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-bovilis-nasalgen-c_en.pdf"},
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    {"id":"57714","name":"CVMP post-authorisation summary of positive opinion for Suvaxyn PRRS MLV","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-02-17T13:43:00Z","last_updated_date":"2023-02-17T13:43:00Z","reference_number":"EMA/CVMP/40684/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-suvaxyn-prrs-mlv_en.pdf-0"},
    {"id":"57715","name":"CVMP post-authorisation summary of positive opinion for Zeleris","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-02-17T13:47:00Z","last_updated_date":"2023-02-17T13:47:00Z","reference_number":"EMA/CVMP/39823/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-zeleris_en.pdf"},
    {"id":"57718","name":"Direct healthcare professional communication (DHPC): ZOLGENSMA (onasemnogene abeparvovec) - Fatal cases of acute liver failure","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-17T15:24:00Z","last_updated_date":"2023-02-17T15:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-zolgensma-onasemnogene-abeparvovec-fatal-cases-acute-liver-failure_en.pdf"},
    {"id":"57720","name":"Direct healthcare professional communication (DHPC): Terlipressin: Serious or fatal respiratory failure and sepsis/septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-17T16:24:00Z","last_updated_date":"2023-02-17T16:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-terlipressin-serious-or-fatal-respiratory-failure-and-sepsisseptic-shock-patients-type-1-hepatorenal-syndrome-type-1-hrs_en.pdf-0"},
    {"id":"57725","name":"Addendum to Assessment report on Agrimonia eupatoria L., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-02-20T10:22:00Z","last_updated_date":"2023-02-20T10:22:00Z","reference_number":"EMA/HMPC/626568/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-agrimonia-eupatoria-l-herba_en.pdf"},
    {"id":"57726","name":"Guideline on declaration of storage conditions: A) in the product information of pharmaceutical veterinary medicinal products B) for active substances","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-02-20T10:28:00Z","last_updated_date":"2023-02-20T10:28:00Z","reference_number":"EMA/CVMP/QWP/857608/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-declaration-storage-conditions-product-information-pharmaceutical-veterinary-medicinal-products-b-active-substances_en.pdf"},
    {"id":"57727","name":"Guideline on Stability Testing: Stability testing of existing active substances and related finished products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-02-20T10:55:00Z","last_updated_date":"2023-07-21T13:30:00Z","reference_number":"EMA/CVMP/QWP/709423/2022,Corr.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-stability-testing-stability-testing-existing-active-substances-and-related-finished-products_en.pdf"},
    {"id":"57728","name":"Guideline on additional Quality requirements for products intended for incorporation into animal feed","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-02-20T11:03:00Z","last_updated_date":"2023-02-20T11:03:00Z","reference_number":"EMA/CVMP/QWP/711629/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-additional-quality-requirements-products-intended-incorporation-animal-feed_en.pdf"},
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    {"id":"57751","name":"Direct healthcare professional communication (DHPC): Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-21T08:40:00Z","last_updated_date":"2023-02-21T08:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-spikevax-bivalent-originalomicron-ba1-pre-filled-syringe-labelling-deviation_en.pdf"},
    {"id":"57753","name":"Direct healthcare professional communication (DHPC): Xalkori (crizotinib): Vision disorders, including risk of severe visual loss, need for monitoring in paediatric patients","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-02-21T10:09:00Z","last_updated_date":"2023-02-21T10:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-xalkori-crizotinib-vision-disorders-including-risk-severe-visual-loss-need-monitoring-paediatric-patients_en.pdf"},
    {"id":"57754","name":"Final European Union herbal monograph on Vaccinium macrocarpon Aiton, fructus","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2023-02-21T12:00:00Z","last_updated_date":"2023-02-21T12:00:00Z","reference_number":"EMA/HMPC/49135/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-vaccinium-macrocarpon-aiton-fructus_en.pdf"},
    {"id":"57755","name":"Opinion of the HMPC on a European Union herbal monograph on Vaccinium macrocarpon Aiton, fructus","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2023-02-21T12:04:00Z","last_updated_date":"2023-02-21T12:04:00Z","reference_number":"EMA/HMPC/15740/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-vaccinium-macrocarpon-aiton-fructus_en.pdf"},
    {"id":"57756","name":"Final assessment report on Vaccinium macrocarpon Aiton, fructus","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-02-21T12:07:00Z","last_updated_date":"2023-02-21T12:07:00Z","reference_number":"EMA/HMPC/517879/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-vaccinium-macrocarpon-aiton-fructus_en.pdf"},
    {"id":"57757","name":"Final list of references supporting the assessment of Vaccinium macrocarpon Aiton, fructus","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2023-02-21T12:09:00Z","last_updated_date":"2023-02-21T12:09:00Z","reference_number":"EMA/HMPC/551668/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-vaccinium-macrocarpon-aiton-fructus_en.pdf"},
    {"id":"57758","name":"Overview of comments received on European Union herbal monograph on Vaccinium macrocarpon Aiton, fructus (EMA/HMPC/49135/2017)","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2023-02-21T12:11:00Z","last_updated_date":"2023-02-21T12:11:00Z","reference_number":"EMA/HMPC/679981/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-vaccinium-macrocarpon-aiton-fructus-emahmpc491352017_en.pdf"},
    {"id":"57763","name":"Agenda - Quarterly system demo - Q1 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-02-21T10:37:00Z","last_updated_date":"2023-03-17T12:48:00Z","reference_number":"EMA/48429/2023 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-quarterly-system-demo-q1-2023_en.pdf"},
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    {"id":"57775","name":"Final European Union herbal monograph on Hypericum perforatum L., herba - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2023-02-22T10:37:00Z","last_updated_date":"2023-02-22T10:37:00Z","reference_number":"EMA/HMPC/7695/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-hypericum-perforatum-l-herba-revision-1_en.pdf"},
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    {"id":"57777","name":"Final assessment report on Hypericum perforatum L., herba - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-02-22T10:43:00Z","last_updated_date":"2023-02-22T10:43:00Z","reference_number":"EMA/HMPC/244315/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-hypericum-perforatum-l-herba-revision-1_en.pdf"},
    {"id":"57778","name":"Final list of references supporting the assessment of Hypericum perforatum L., herba - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2023-02-22T10:47:00Z","last_updated_date":"2023-02-22T10:47:00Z","reference_number":"EMA/HMPC/45511/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-hypericum-perforatum-l-herba-revision-1_en.pdf"},
    {"id":"57779","name":"Overview of comments received on European Union herbal monograph on Hypericum perforatum L., herba (traditional use) (EMA/HMPC/45508/2017) - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2023-02-22T10:49:00Z","last_updated_date":"2023-02-22T10:49:00Z","reference_number":"EMA/HMPC/536348/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-hypericum-perforatum-l-herba-traditional-use-emahmpc455082017-revision-1_en.pdf"},
    {"id":"57780","name":"Overview of comments received on European Union herbal monograph on Hypericum perforatum L., herba (well-established use and traditional use) (EMA/HMPC/7695/2021) - Revision 1","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2023-02-22T10:51:00Z","last_updated_date":"2023-02-22T10:51:00Z","reference_number":"EMA/HMPC/72258/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-hypericum-perforatum-l-herba-well-established-use-and-traditional-use-emahmpc76952021-revision-1_en.pdf"},
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    {"id":"57805","name":"Scientific advice and protocol assistance Adopted during the CHMP meeting 20-23 February 2023","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2023-02-24T12:00:00Z","last_updated_date":"2023-02-24T12:00:00Z","reference_number":"EMA/CHMP/SAWP/84536/2023","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/scientific-advice-and-protocol-assistance-adopted-during-chmp-meeting-20-23-february-2023_en.pdf"},
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    {"id":"57811","name":"CHMP summary of positive opinion for Akeega","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-02-24T10:21:00Z","last_updated_date":"2023-02-24T10:21:00Z","reference_number":"EMA/CHMP/55463/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-akeega_en.pdf"},
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    {"id":"57902","name":"Presentation - 1.2 European Medicines Agencies Network initiatives - Lorraine Nolan (HMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T12:48:00Z","last_updated_date":"2023-03-07T12:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-12-european-medicines-agencies-network-initiatives-lorraine-nolan-hma_en.pdf"},
    {"id":"57903","name":"Presentation - 1.4 Monitoring of events and preparedness for Public Health Emergencies (PHE) - Anthony Humphreys (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T12:54:00Z","last_updated_date":"2023-03-07T12:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-14-monitoring-events-and-preparedness-public-health-emergencies-phe-anthony-humphreys-ema_en.pdf"},
    {"id":"57904","name":"Presentation - 1.5 What happened with the HMA-EMA Task Force on availability of authorised medicines (TF AAM) since 2018","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T12:56:00Z","last_updated_date":"2023-03-07T12:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-15-what-happened-hma-ema-task-force-availability-authorised-medicines-tf-aam-2018_en.pdf"},
    {"id":"57905","name":"Presentation - 2A.1 Overview of immunoglobulins supply situation in the EU - Klaus Kruttwig (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T12:58:00Z","last_updated_date":"2023-03-07T12:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2a1-overview-immunoglobulins-supply-situation-eu-klaus-kruttwig-ema_en.pdf"},
    {"id":"57906","name":"Presentation - 2A.2 EU legislation and policy on blood and blood components - Stefaan van der Spiegel (DG SANTE, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:02:00Z","last_updated_date":"2023-03-07T13:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2a2-eu-legislation-and-policy-blood-and-blood-components-stefaan-van-der-spiegel-dg-sante-ec_en.pdf"},
    {"id":"57908","name":"Presentation - 2B Breakout session - Biosimilars - Steffen Thirstrup (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:16:00Z","last_updated_date":"2023-03-07T13:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2b-breakout-session-biosimilars-steffen-thirstrup-ema_en.pdf"},
    {"id":"57909","name":"Presentation - 2B.1 Work plan of the HMA Biosimilar Working Group (BSWG) - Esa Heinonen (HMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:16:00Z","last_updated_date":"2023-03-07T13:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2b1-work-plan-hma-biosimilar-working-group-bswg-esa-heinonen-hma_en.pdf"},
    {"id":"57910","name":"Presentation - 2B.2 Scientific rationale for interchangeability of biosimilars in the EU - Elena Wolff-Holz (PEI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:16:00Z","last_updated_date":"2023-03-07T13:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2b2-scientific-rationale-interchangeability-biosimilars-eu-elena-wolff-holz-pei_en.pdf"},
    {"id":"57911","name":"Presentation - 2B.3 HMA-EMA statement on interchangeability of biosimilars - Steffen Thirstrup (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:16:00Z","last_updated_date":"2023-03-07T13:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2b3-hma-ema-statement-interchangeability-biosimilars-steffen-thirstrup-ema_en.pdf"},
    {"id":"57912","name":"Presentation - 2B.4 Rapporteur session - Rosa Gonzalez-Quevedo (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:16:00Z","last_updated_date":"2023-03-07T13:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2b4-rapporteur-session-rosa-gonzalez-quevedo-ema_en.pdf"},
    {"id":"57913","name":"Presentation - 2C.1 Medicines for veterinary use - Nancy de Briyne (FVE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:43:00Z","last_updated_date":"2023-03-07T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2c1-medicines-veterinary-use-nancy-de-briyne-fve_en.pdf"},
    {"id":"57914","name":"Presentation - 2C.2 Medicines for veterinary use - Elsa Vecino (Accessvetmed)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:43:00Z","last_updated_date":"2023-03-07T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2c2-medicines-veterinary-use-elsa-vecino-accessvetmed_en.pdf"},
    {"id":"57915","name":"Presentation - 2C.3 Medicines for veterinary use - Rick Clayton (AnimalHealthEurope)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:43:00Z","last_updated_date":"2023-03-07T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2c3-medicines-veterinary-use-rick-clayton-animalhealtheurope_en.pdf"},
    {"id":"57916","name":"Presentation - 2C.4 Medicines for veterinary use - Paule Carnat-Gautier (ANSES)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:43:00Z","last_updated_date":"2023-03-07T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2c4-medicines-veterinary-use-paule-carnat-gautier-anses_en.pdf"},
    {"id":"57917","name":"Presentation - 2C.5 Medicines for veterinary use - Inke Reimer (BVL)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:43:00Z","last_updated_date":"2023-03-07T13:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2c5-medicines-veterinary-use-inke-reimer-bvl_en.pdf"},
    {"id":"57918","name":"Presentation - 2C.6 Rapporteur session - Janos Kovacs (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:44:00Z","last_updated_date":"2023-03-07T13:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2c6-rapporteur-session-janos-kovacs-ema_en.pdf"},
    {"id":"57919","name":"Presentation - 3.1 Prevention of shortages - Ancel.la Santos (BEUC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:50:00Z","last_updated_date":"2023-03-07T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-31-prevention-shortages-ancella-santos-beuc_en.pdf"},
    {"id":"57920","name":"Presentation - 3.2 Prevention of shortages - Stephan Roenninger (Industry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:50:00Z","last_updated_date":"2023-03-07T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-32-prevention-shortages-stephan-roenninger-industry_en.pdf"},
    {"id":"57921","name":"Presentation - 3.3 Prevention of shortages - Jorge Batista (PGEU)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:50:00Z","last_updated_date":"2023-03-07T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-33-prevention-shortages-jorge-batista-pgeu_en.pdf"},
    {"id":"57922","name":"Presentation - 3.4 Prevention of shortages - Nancy De Biyne (FVE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:50:00Z","last_updated_date":"2023-03-07T13:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-34-prevention-shortages-nancy-de-biyne-fve_en.pdf"},
    {"id":"57923","name":"Presentation - 3.5 Network priorities to 2025 TF AAM workplan - Maria-Jesus Alcaraz Tomas (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:51:00Z","last_updated_date":"2023-03-07T13:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-35-network-priorities-2025-tf-aam-workplan-maria-jesus-alcaraz-tomas-ema_en.pdf"},
    {"id":"57924","name":"Presentation - 4 Permanent withdrawals of medicinal products from the market - Momir Radulovic (HMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:57:00Z","last_updated_date":"2023-03-07T13:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-4-permanent-withdrawals-medicinal-products-market-momir-radulovic-hma_en.pdf"},
    {"id":"57925","name":"Presentation - 4.1 Permanent withdrawals from the market - Charlotte Roffiaen (EPHA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:57:00Z","last_updated_date":"2023-03-07T13:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-41-permanent-withdrawals-market-charlotte-roffiaen-epha_en.pdf"},
    {"id":"57926","name":"Presentation - 4.2 Permanent withdrawals from the market - Mary McCarthy (UEMO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:57:00Z","last_updated_date":"2023-03-07T13:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-42-permanent-withdrawals-market-mary-mccarthy-uemo_en.pdf"},
    {"id":"57927","name":"Presentation - 4.3 Permanent withdrawals from the market - Adrian van den Hoven (Industry)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:57:00Z","last_updated_date":"2023-03-07T13:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-43-permanent-withdrawals-market-adrian-van-den-hoven-industry_en.pdf"},
    {"id":"57928","name":"Presentation - 4.4 Permanent withdrawals from the market - Michael Ermisch (GKV-Spitzenverband)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:57:00Z","last_updated_date":"2023-03-07T13:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-44-permanent-withdrawals-market-michael-ermisch-gkv-spitzenverband_en.pdf"},
    {"id":"57929","name":"Presentation - 4.5 Permanent withdrawals from the market - Matjaz Marc (JAZMP, SPOC WP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:58:00Z","last_updated_date":"2023-03-07T13:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-45-permanent-withdrawals-market-matjaz-marc-jazmp-spoc-wp_en.pdf"},
    {"id":"57930","name":"Presentation - 4.6 Network priorities to 2025 - TF AAM workplan - Joao Ferreira (EMA), Michael Berntgen (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T13:58:00Z","last_updated_date":"2023-03-07T13:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-46-network-priorities-2025-tf-aam-workplan-joao-ferreira-ema-michael-berntgen-ema_en.pdf"},
    {"id":"57931","name":"Presentation - 5.1 Patients’ perspective on communication and transparency - Marko KorenjaK (PCWP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T14:08:00Z","last_updated_date":"2023-03-07T14:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-51-patients-perspective-communication-and-transparency-marko-korenjak-pcwp_en.pdf"},
    {"id":"57932","name":"Presentation - 5.2 Communication and transparency - Jean-François Duliere (Industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T14:08:00Z","last_updated_date":"2023-03-07T14:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-52-communication-and-transparency-jean-francois-duliere-industry_en.pdf"},
    {"id":"57933","name":"Presentation - 5.3 Communication and transparency - the Healthcare Professionals' perspective - Rosa Giuliani (HCPWP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T14:14:00Z","last_updated_date":"2023-03-07T14:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-53-communication-and-transparency-healthcare-professionals-perspective-rosa-giuliani-hcpwp_en.pdf"},
    {"id":"57934","name":"Presentation - 5.4 Shortages and communication - paralel timelines - Diego Pernas (AEMSP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T14:19:00Z","last_updated_date":"2023-03-07T14:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-54-shortages-and-communication-paralel-timelines-diego-pernas-aemsp_en.pdf"},
    {"id":"57935","name":"Presentation - 5.5 Network priorities to 2025 - TF AAM workplan - Juan Garcia Burgos, Inga Abed (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T14:19:00Z","last_updated_date":"2023-03-07T14:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-55-network-priorities-2025-tf-aam-workplan-juan-garcia-burgos-inga-abed-ema_en.pdf"},
    {"id":"57937","name":"CHMP meeting dates 2023, 2024, 2025 and 2026","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-03-07T15:40:00Z","last_updated_date":"2023-03-07T15:40:00Z","reference_number":"EMA/73125/2023","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-meeting-dates-2023-2024-2025-and-2026_en.pdf"},
    {"id":"57950","name":"Results for EU Survey on proposed use cases - Second Veterinary Big Data Stakeholder Forum","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T13:25:00Z","last_updated_date":"2023-03-08T13:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/results-eu-survey-proposed-use-cases-second-veterinary-big-data-stakeholder-forum_en.pdf"},
    {"id":"57951","name":"Conclusions - Second Veterinary Big Data Stakeholder Forum","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T13:33:00Z","last_updated_date":"2023-03-08T13:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/conclusions-second-veterinary-big-data-stakeholder-forum_en.pdf"},
    {"id":"57953","name":"Highlight report - Ninth industry stakeholder platform on research and development support","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T13:48:00Z","last_updated_date":"2023-03-08T13:48:00Z","reference_number":"EMA/923972/2022","document_url":"https://www.ema.europa.eu/en/documents/report/highlight-report-ninth-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"57956","name":"Presentation 2A.3 - SUPPLY Project: Availability of IV/SC human normal immunoglobulins in the EU/EEA - Fabio Candura (ISS) Daphne Thijssen-Timmer (European Blood Alliance)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T16:58:00Z","last_updated_date":"2023-03-08T16:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-2a3-supply-project-availability-ivsc-human-normal-immunoglobulins-eueea-fabio-candura-iss-daphne-thijssen-timmer-european-blood-alliance_en.pdf"},
    {"id":"57957","name":"Presentation: Clinical Trials Information System (CTIS) bitesize talk: Document and personal data in CTIS","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T13:00:00Z","last_updated_date":"2023-03-08T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-information-system-ctis-bitesize-talk-document-and-personal-data-ctis_en.pdf"},
    {"id":"57961","name":"Human medicines highlights - March 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T09:12:00Z","last_updated_date":"2023-03-09T09:12:00Z","reference_number":"Issue 167","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-march-2023_en.pdf"},
    {"id":"57964","name":"Presentation - Reorganisation of EMA working parties - A. Ganan Jimenez (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T14:57:00Z","last_updated_date":"2023-03-09T14:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reorganisation-ema-working-parties-ganan-jimenez-ema_en.pdf"},
    {"id":"57965","name":"Presentation - The Scientific Advice Working Party (SAWP) and its interaction with other WPs and groups - I. Gravanis (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:00:00Z","last_updated_date":"2023-03-09T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-scientific-advice-working-party-sawp-and-its-interaction-other-wps-and-groups-i-gravanis-ema_en.pdf"},
    {"id":"57966","name":"Presentation - Methodology Working Party - A. Thomson (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:04:00Z","last_updated_date":"2023-03-09T15:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-methodology-working-party-thomson-ema_en.pdf"},
    {"id":"57967","name":"Presentation - CHMP/CVMP 3Rs Working party (3RsWP) - S. Ponzano (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:06:00Z","last_updated_date":"2023-03-09T15:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmpcvmp-3rs-working-party-3rswp-s-ponzano-ema_en.pdf"},
    {"id":"57968","name":"Presentation - Highlights on the Committee for Advanced Therapies - M. de Lemus Belmonte (CAT)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:08:00Z","last_updated_date":"2023-03-09T15:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-highlights-committee-advanced-therapies-m-de-lemus-belmonte-cat_en.pdf"},
    {"id":"57969","name":"Presentation - PCWP/HCPWP feedback from CHMP - F. Ventura and C. Prieto (CHMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:10:00Z","last_updated_date":"2023-03-09T15:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwphcpwp-feedback-chmp-f-ventura-and-c-prieto-chmp_en.pdf"},
    {"id":"57970","name":"Presentation - PCWP/HCPWP feedback from COMP - E. Rook and T. Leest (COMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:12:00Z","last_updated_date":"2023-03-09T15:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwphcpwp-feedback-comp-e-rook-and-t-leest-comp_en.pdf"},
    {"id":"57971","name":"Presentation - PCWP/HCPWP feedback from HMPC - O. Palomino and A. Lê (HMPC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:17:00Z","last_updated_date":"2023-03-09T15:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwphcpwp-feedback-hmpc-o-palomino-and-le-hmpc_en.pdf"},
    {"id":"57972","name":"Presentation - PCWP/HCPWP feedback from PDCO - J. Taminiau (PDCO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:22:00Z","last_updated_date":"2023-03-09T15:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pcwphcpwp-feedback-pdco-j-taminiau-pdco_en.pdf"},
    {"id":"57974","name":"Presentation - ACT EU Multistakeholder platform concept paper consultation and kick-off meeting - M. Filancia (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:26:00Z","last_updated_date":"2023-03-09T15:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-act-eu-multistakeholder-platform-concept-paper-consultation-and-kick-meeting-m-filancia-ema_en.pdf"},
    {"id":"57975","name":"Presentation - Biosimilar Breakout Session : HMA-EMA Multi-stakeholder workshop on shortages - S. Thirstrup and R. Gonzalez-Quevedo (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:28:00Z","last_updated_date":"2023-03-09T15:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-biosimilar-breakout-session-hma-ema-multi-stakeholder-workshop-shortages-s-thirstrup-and-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"57976","name":"Presentation - Interchangeability of biosimilars: Joint EMA-HMA statement - R. Gonzalez-Quevedo (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:31:00Z","last_updated_date":"2023-03-09T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interchangeability-biosimilars-joint-ema-hma-statement-r-gonzalez-quevedo-ema_en.pdf"},
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    {"id":"57978","name":"Presentation - Multilingualism on the EMA website and in external communications - M. Benstetter (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T15:36:00Z","last_updated_date":"2023-03-09T15:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multilingualism-ema-website-and-external-communications-m-benstetter-ema_en.pdf"},
    {"id":"57980","name":"Esomeprazole / naproxen : List of nationally authorised medicinal products - PSUSA/00001270/202204","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T16:41:00Z","last_updated_date":"2023-03-09T16:41:00Z","reference_number":"EMA/108915/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/esomeprazole-naproxen-list-nationally-authorised-medicinal-products-psusa00001270202204_en.pdf"},
    {"id":"57981","name":"Esomeprazole / naproxen : CMDh scientific conclusions, amendments to product information and implementation timetable - 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    {"id":"57985","name":"Guideline on computerised systems and electronic data in clinical trials","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-03-10T09:20:00Z","last_updated_date":"2023-03-10T09:20:00Z","reference_number":"EMA/INS/GCP/112288/2023","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf"},
    {"id":"57987","name":"CTIS newsflash - 10 March 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-03-10T11:39:00Z","last_updated_date":"2023-03-10T11:39:00Z","reference_number":"EMA/103161/2023","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-10-march-2023_en.pdf"},
    {"id":"57993","name":"Venlafaxine : List of nationally authorised medicinal products - PSUSA/00003104/202205","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-03-10T16:32:00Z","last_updated_date":"2023-03-10T16:32:00Z","reference_number":"EMA/115290/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/venlafaxine-list-nationally-authorised-medicinal-products-psusa00003104202205_en.pdf"},
    {"id":"57994","name":"Venlafaxine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"58088","name":"Public statement on Nevirapine Teva : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-03-21T12:36:00Z","last_updated_date":"2023-03-21T12:36:00Z","reference_number":"EMA/112293/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-nevirapine-teva-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"58090","name":"Public statement on Lamivudine/Zidovudine Teva : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-03-21T14:40:00Z","last_updated_date":"2023-03-21T14:40:00Z","reference_number":"EMA/102784/2003","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-lamivudinezidovudine-teva-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"58096","name":"Agenda - Fourth Industry Standing Group (ISG) meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-03-21T15:22:00Z","last_updated_date":"2023-03-21T15:22:00Z","reference_number":"EMA/909712/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fourth-industry-standing-group-isg-meeting_en.pdf"},
    {"id":"58101","name":"2022 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-03-21T16:19:00Z","last_updated_date":"2023-03-21T16:19:00Z","reference_number":"EMA/900566/2022","document_url":"https://www.ema.europa.eu/en/documents/report/2022-annual-report-eudravigilance-european-parliament-council-and-commission_en.pdf"},
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    {"id":"58115","name":"Pholcodine-containing medicinal products Article-107i referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2023-03-22T11:01:00Z","last_updated_date":"2023-03-22T11:01:00Z","reference_number":"EMA/950036/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-assessment-report_en.pdf"},
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    {"id":"58120","name":"Janus Kinase inhibitors (JAKi) Article-20 procedure - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-03-22T13:32:00Z","last_updated_date":"2023-03-22T13:32:00Z","reference_number":"EMA/586384/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/janus-kinase-inhibitors-jaki-article-20-procedure-assessment-report_en.pdf"},
    {"id":"58129","name":"Clindamycin phosphate / tretinoin : List of nationally authorised medicinal products - PSUSA/00010080/202207","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-03-23T09:08:00Z","last_updated_date":"2023-03-23T09:08:00Z","reference_number":"EMA/105133/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/clindamycin-phosphate-tretinoin-list-nationally-authorised-medicinal-products-psusa00010080202207_en.pdf"},
    {"id":"58136","name":"Presentation - Trial to optimize immunotherapy in early TNBC (M. Ignatiadis, Institut Bordet, Université Libre de Bruxelles)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T10:15:00Z","last_updated_date":"2023-03-24T10:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-trial-optimize-immunotherapy-early-tnbc-m-ignatiadis-institut-bordet-universite-libre-de-bruxelles_en.pdf"},
    {"id":"58138","name":"Presentation - Case study on TNBC optimisation trial (Institut Bordet)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T10:28:00Z","last_updated_date":"2023-03-24T10:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-tnbc-optimisation-trial-institut-bordet_en.pdf"},
    {"id":"58139","name":"Minutes of the Cancer Medicines Forum - 20 December 2022","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T10:41:00Z","last_updated_date":"2023-03-24T10:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cancer-medicines-forum-20-december-2022_en.pdf"},
    {"id":"58140","name":"Presentation - Post-authorisation Safety and Efficacy studies (C. Voltz-Girolt, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T10:42:00Z","last_updated_date":"2023-03-24T10:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-post-authorisation-safety-and-efficacy-studies-c-voltz-girolt-ema_en.pdf"},
    {"id":"58141","name":"Presentation - Feasibility of post- authorization randomized controlled trials for conditionally authorized anticancer medicines - a multistakeholder perspective (C. van Hattem; A. de Jong; J. de Groot; L. Bloem, Utrecht University)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T10:43:00Z","last_updated_date":"2023-03-24T10:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feasibility-post-authorization-randomized-controlled-trials-conditionally-authorized-anticancer-medicines-multistakeholder-perspective-c-van-hattem-de-jong-j-de-groot-l-bloem-utrecht_en.pdf"},
    {"id":"58143","name":"Presentation - Outcome from 2022 ISG Survey and Key Industry stakeholder 2023 meetings (M.Filancia, L.Malaguti, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T11:01:00Z","last_updated_date":"2023-03-24T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-outcome-2022-isg-survey-and-key-industry-stakeholder-2023-meetings-mfilancia-lmalaguti-ema_en.pdf"},
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    {"id":"58146","name":"Presentation - Clinical Trials Regulation (CTR) implementation and ACT EU update (P.Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T11:01:00Z","last_updated_date":"2023-03-24T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-trials-regulation-ctr-implementation-and-act-eu-update-parlett-ema_en.pdf"},
    {"id":"58147","name":"Presentation - Emergency Task Force (ETF) implementation update including preparedness activities (M.Mura, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T11:01:00Z","last_updated_date":"2023-03-24T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emergency-task-force-etf-implementation-update-including-preparedness-activities-mmura-ema_en.pdf"},
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    {"id":"58150","name":"Presentation - Update on European Shortages Monitoring Platform (ESMP) development progress and roadmap (P. Pina Ferreira, S. Zastavnik, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T11:01:00Z","last_updated_date":"2023-03-24T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-european-shortages-monitoring-platform-esmp-development-progress-and-roadmap-p-pina-ferreira-s-zastavnik-ema_en.pdf"},
    {"id":"58151","name":"Presentation - Update on medicine shortages activities (J. Ferreira, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T11:01:00Z","last_updated_date":"2023-03-24T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-medicine-shortages-activities-j-ferreira-ema_en.pdf"},
    {"id":"58155","name":"Direct healthcare professional communication (DHPC) : Pholcodine-containing medicinal products no longer available on the EU market","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-03-27T14:10:00Z","last_updated_date":"2023-03-27T14:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-pholcodine-containing-medicinal-products-no-longer-available-eu-market_en.pdf"},
    {"id":"58159","name":"Agnes Saint-Raymond - Assessment outcome of occupational activities after leaving the service (March 2023)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-03-24T15:00:00Z","last_updated_date":"2023-03-24T15:00:00Z","reference_number":"EMA/133985/2023","document_url":"https://www.ema.europa.eu/en/documents/other/agnes-saint-raymond-assessment-outcome-occupational-activities-after-leaving-service-march-2023_en.pdf"},
    {"id":"58160","name":"CVMP summary of positive opinion for Newflend ND H9","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-03-24T15:51:00Z","last_updated_date":"2023-03-24T15:51:00Z","reference_number":"EMA/CVMP/116044/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-newflend-nd-h9_en.pdf"},
    {"id":"58163","name":"Agenda of the CHMP meeting 27-30 March 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-03-27T12:19:00Z","last_updated_date":"2023-03-27T12:19:00Z","reference_number":"EMA/CHMP/47815/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-27-30-march-2023_en.pdf"},
    {"id":"58164","name":"CTIS newsflash – 24 March 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-03-27T12:50:00Z","last_updated_date":"2023-03-27T12:50:00Z","reference_number":"EMA/127714/2023","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-24-march-2023_en.pdf"},
    {"id":"58165","name":"Draft list of references supporting the assessment of Aesculus hippocastanum L., cortex - Revision 1","type":"herbal-references","status":"Draft","consultation_date":"","first_published_date":"2023-03-27T15:25:00Z","last_updated_date":"2023-03-27T15:25:00Z","reference_number":"EMA/HMPC/596129/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-aesculus-hippocastanum-l-cortex-revision-1_en.pdf"},
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    {"id":"58167","name":"Draft European Union herbal monograph on Aesculus hippocastanum L., cortex - Revision 1","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2023-03-27T15:33:00Z","last_updated_date":"2023-03-27T15:33:00Z","reference_number":"EMA/HMPC/596130/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-aesculus-hippocastanum-l-cortex-revision-1_en.pdf"},
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    {"id":"58174","name":"Withdrawal letter: Feraheme","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-03-31T11:57:00Z","last_updated_date":"2023-03-31T11:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-feraheme_en.pdf"},
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    {"id":"58191","name":"Pholcodine-containing medicinal products Article-107i referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-03-29T09:19:00Z","last_updated_date":"2023-03-29T09:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_fr.pdf","ga":"https://www.ema.europa.eu/ga/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_ga.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-annex-i_sv.pdf"}},
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    {"id":"58210","name":"Direct healthcare professional communication (DHPC) : Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolism and mortality with use of Janus kinase inhibitors (JAKi)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-03-30T10:00:00Z","last_updated_date":"2023-03-30T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-updated-recommendations-minimise-risks-malignancy-major-adverse-cardiovascular-events-serious-infections-venous-thromboembolism-and-mortality-use_en.pdf"},
    {"id":"58213","name":"Public statement on Dasatinib Accord : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-03-30T11:21:00Z","last_updated_date":"2023-03-30T11:21:00Z","reference_number":"EMA/145383/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-dasatinib-accord-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"58216","name":"Public statement on Dasatinib Accordpharma : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-03-30T11:58:00Z","last_updated_date":"2023-03-30T11:58:00Z","reference_number":"EMA/145575/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-dasatinib-accordpharma-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"58219","name":"Agenda of the Medicine Shortages (SPOC) Working Party meeting 13 December 2022","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-03-30T12:34:00Z","last_updated_date":"2023-03-30T12:34:00Z","reference_number":"EMA/93474/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-13-december-2022_en.pdf"},
    {"id":"58221","name":"Agenda of the Medicine Shortages (SPOC) Working Party 18 January 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-03-30T12:42:00Z","last_updated_date":"2023-03-30T12:42:00Z","reference_number":"EMA/93494/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-18-january-2023_en.pdf"},
    {"id":"58223","name":"Agenda of the Medicine Shortages (SPOC) Working Party 15 February 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-03-30T12:47:00Z","last_updated_date":"2023-03-30T12:47:00Z","reference_number":"EMA/93334/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-15-february-2023_en.pdf"},
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    {"id":"58226","name":"CHMP post-authorisation summary of positive opinion for Tenkasi (II-37)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-03-31T12:00:00Z","last_updated_date":"2023-03-31T12:00:00Z","reference_number":"EMA/CHMP/150406/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tenkasi-ii-37_en.pdf"},
    {"id":"58227","name":"CHMP summary of positive opinion for Bimervax","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-03-30T15:19:00Z","last_updated_date":"2023-03-30T15:19:00Z","reference_number":"EMA/141306/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bimervax_en.pdf"},
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    {"id":"58307","name":"Delapril / manidipine, delapril / indapamide : List of nationally authorised medicinal products - PSUSA/00010496/202206","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-04-11T10:20:00Z","last_updated_date":"2023-04-11T10:20:00Z","reference_number":"EMA/163351/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/delapril-manidipine-delapril-indapamide-list-nationally-authorised-medicinal-products-psusa00010496202206_en.pdf"},
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    {"id":"58658","name":"Hydroxyprogesterone-containing medicinal products Article 31-referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-05-12T14:17:00Z","last_updated_date":"2023-05-12T14:17:00Z","reference_number":"EMA/203354/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyprogesterone-containing-medicinal-products-article-31-referral-review-started_en.pdf"},
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    {"id":"58675","name":"Presentation - Adverse events among children ages 5-11 years after COVID-19 vaccination: updates from v-safe and the Vaccine Adverse Event Reporting System (VAERS) - CDC COVID-19 Vaccine Task Force","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-12T16:45:00Z","last_updated_date":"2023-05-12T16:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adverse-events-among-children-ages-5-11-years-after-covid-19-vaccination-updates-v-safe-and-vaccine-adverse-event-reporting-system-vaers-cdc-covid-19-vaccine-task-force_en.pdf"},
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    {"id":"58682","name":"2022 annual report of the European Medicines Agency","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2023-05-15T16:10:00Z","last_updated_date":"2023-05-15T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/2022-annual-report-european-medicines-agency_en.pdf"},
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    {"id":"58694","name":"Electronic Application Form (eAF) - Product Management Service (PMS) newsletter - Issue 3","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-05-15T17:00:00Z","last_updated_date":"2023-05-15T17:00:00Z","reference_number":"Issue 3","document_url":"https://www.ema.europa.eu/en/documents/newsletter/electronic-application-form-eaf-product-management-service-pms-newsletter-issue-3_en.pdf"},
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    {"id":"58700","name":"Aminosalicylic acid - List of nationally authorised medicinal products - PSUSA/00000165/202210","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T14:41:00Z","last_updated_date":"2023-05-16T14:41:00Z","reference_number":"EMA/223477/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/aminosalicylic-acid-list-nationally-authorised-medicinal-products-psusa00000165202210_en.pdf"},
    {"id":"58708","name":"Implementing measures under Article 114(3) of Regulation (EU) 2019/6 as regards substances used in veterinary medicinal products authorised in the Union which may be used in food-producing aquatic species in accordance with Article 114(1)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-05-16T16:00:00Z","last_updated_date":"2023-05-16T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/implementing-measures-under-article-1143-regulation-eu-20196-regards-substances-used-veterinary-medicinal-products-authorised-union-which-may-be-used-food-producing-aquatic-species-accordance-article_en.pdf"},
    {"id":"58714","name":"Report - Listen and learn focus group meeting of the Quality Innovation Group","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-05-17T10:21:00Z","last_updated_date":"2023-05-17T10:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-listen-and-learn-focus-group-meeting-quality-innovation-group_en.pdf"},
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    {"id":"58722","name":"Agenda - Product Management Service (PMS) Progress Webinar","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-05-17T15:35:00Z","last_updated_date":"2023-05-17T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-product-management-service-pms-progress-webinar_en.pdf"},
    {"id":"58724","name":"Agenda of the CHMP meeting 22-25 May 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-05-22T10:46:00Z","last_updated_date":"2023-05-22T10:46:00Z","reference_number":"EMA/CHMP/122959/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-22-25-may-2023_en.pdf"},
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    {"id":"58732","name":"Janus Kinase inhibitors (JAKi) Article-20 procedure - EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory 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    {"id":"58734","name":"Presentation - 3RsWP 2023 Workplan","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-22T12:02:00Z","last_updated_date":"2023-05-22T12:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-3rswp-2023-workplan_en.pdf"},
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    {"id":"58736","name":"CVMP summary of positive opinion for Eluracat","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-05-22T14:38:00Z","last_updated_date":"2023-05-22T14:38:00Z","reference_number":"EMA/CVMP/194243/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-eluracat_en.pdf"},
    {"id":"58738","name":"Presentation - Step I - Scope and updates","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-22T17:35:00Z","last_updated_date":"2023-05-22T17:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-step-i-scope-and-updates_en.pdf"},
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    {"id":"58754","name":"Presentation - Qualifying PROs for rheumatology studies – update from EULAR (Robert B.M. Landewé)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-24T10:39:00Z","last_updated_date":"2023-05-24T10:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qualifying-pros-rheumatology-studies-update-eular-robert-bm-landewe_en.pdf"},
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    {"id":"58761","name":"Presentation - The Cystic Fibrosis experience (Lutz Naehrlich)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-24T10:59:00Z","last_updated_date":"2023-05-24T10:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cystic-fibrosis-experience-lutz-naehrlich_en.pdf"},
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    {"id":"58764","name":"Felbamate : List of nationally authorised medicinal products - PSUSA/00010155/202209","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-05-24T13:09:00Z","last_updated_date":"2023-05-24T13:09:00Z","reference_number":"EMA/236371/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/felbamate-list-nationally-authorised-medicinal-products-psusa00010155202209_en.pdf"},
    {"id":"58765","name":"Etomidate : List of nationally authorised medicinal products - PSUSA/00001330/202209","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-05-24T13:17:00Z","last_updated_date":"2023-05-24T13:17:00Z","reference_number":"EMA/236429/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/etomidate-list-nationally-authorised-medicinal-products-psusa00001330202209_en.pdf"},
    {"id":"58767","name":"Etidronate : List of nationally authorised medicinal products - PSUSA/00001320/202209","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-05-24T13:40:00Z","last_updated_date":"2023-05-24T13:40:00Z","reference_number":"EMA/238177/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/etidronate-list-nationally-authorised-medicinal-products-psusa00001320202209_en.pdf"},
    {"id":"58769","name":"Withdrawal letter: Asimtufii","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-05-26T12:00:00Z","last_updated_date":"2023-05-26T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-asimtufii_en.pdf"},
    {"id":"58770","name":"Withdrawal letter: Susvimo","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-05-26T16:28:00Z","last_updated_date":"2023-05-26T16:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-susvimo_en.pdf"},
    {"id":"58773","name":"Report - HMA/EMA multi-stakeholder workshop on shortages","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-05-25T09:30:00Z","last_updated_date":"2023-05-25T09:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/report-hmaema-multi-stakeholder-workshop-shortages_en.pdf"},
    {"id":"58775","name":"Report - Moving together towards better prevention of medicine shortages in the EU","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-05-25T10:22:00Z","last_updated_date":"2023-05-25T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-moving-together-towards-better-prevention-medicine-shortages-eu_en.pdf"},
    {"id":"58780","name":"Programme - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) live virtual training courses for sponsors - October and November 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-05-25T13:14:00Z","last_updated_date":"2023-07-12T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/programme-extended-eudravigilance-medicinal-product-dictionary-xevmpd-live-virtual-training-courses-sponsors-october-and-november-2023_en.pdf"},
    {"id":"58781","name":"Programme - eXtended EudraVigilance Medicinal Product Dictionary training courses - September, October and November 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-05-25T13:24:00Z","last_updated_date":"2023-07-12T14:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/programme-extended-eudravigilance-medicinal-product-dictionary-training-courses-september-october-and-november-2023_en.pdf"},
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    {"id":"58805","name":"Presentation - Case study on a VMP with flexible composition to treat diarrhea caused by ETEC in post-weaning piglets (Susana Casado)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-26T16:25:00Z","last_updated_date":"2023-05-26T16:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-vmp-flexible-composition-treat-diarrhea-caused-etec-post-weaning-piglets-susana-casado_en.pdf"},
    {"id":"58806","name":"Presentation - Draft Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (quality part) (Martin B. Oleksiewicz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-26T16:39:00Z","last_updated_date":"2023-05-26T16:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-guideline-quality-safey-and-efficacy-veterinary-medicinal-products-specifically-designed-phage-therapy-quality-part-martin-b-oleksiewicz_en.pdf"},
    {"id":"58807","name":"Presentation - Draft Guideline on quality, safey and efficacy of veterinary medicinal products specifically designed for phage therapy (safey part) (Sandra-Maria Wienhold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-26T16:42:00Z","last_updated_date":"2023-05-26T16:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-draft-guideline-quality-safey-and-efficacy-veterinary-medicinal-products-specifically-designed-phage-therapy-safey-part-sandra-maria-wienhold_en.pdf"},
    {"id":"58808","name":"Presentation - Setting the scene introduction on the background and expected outputs for the meeting (Susana Casado)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-26T16:45:00Z","last_updated_date":"2023-05-26T16:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-setting-scene-introduction-background-and-expected-outputs-meeting-susana-casado_en.pdf"},
    {"id":"58811","name":"Agenda and registration form - Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Virtual hands-on training course using the EudraVigilance system (September-December 2023)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-05-30T13:07:00Z","last_updated_date":"2023-05-30T13:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/agenda-and-registration-form-mandatory-use-isoich-e2br3-individual-case-safety-reporting-eu-virtual-hands-training-course-using-eudravigilance-system-september-december-2023_en.pdf"},
    {"id":"58812","name":"Withdrawal assessment report for Tidhesco","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-05-30T13:58:00Z","last_updated_date":"2023-05-30T13:58:00Z","reference_number":"EMA/173663/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-tidhesco_en.pdf"},
    {"id":"58813","name":"Presentation - Product Lifecycle Management (PLM) Portal Access Management Training Session","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-30T14:30:00Z","last_updated_date":"2023-05-30T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-lifecycle-management-plm-portal-access-management-training-session_en.pdf"},
    {"id":"58814","name":"Programme - Clinical Trials Information System (CTIS) sponsor end user training programme (Sep, Nov, Dec 2023)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-05-30T16:15:00Z","last_updated_date":"2023-07-03T17:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-clinical-trials-information-system-ctis-sponsor-end-user-training-programme-sep-nov-dec-2023_en.pdf"},
    {"id":"58825","name":"CHMP PROM agenda for the meeting on 16 January 2023","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-05-31T12:35:00Z","last_updated_date":"2023-05-31T12:35:00Z","reference_number":"EMA/CHMP/953415/2022 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/agenda/chmp-prom-agenda-meeting-16-january-2023_en.pdf"},
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    {"id":"58937","name":"Final opinion of the HMPC on a European Union herbal monograph on Juniperus communis L., galbulus (pseudo- fructus) - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T14:40:00Z","last_updated_date":"2023-06-13T14:40:00Z","reference_number":"EMA/HMPC/170276/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-juniperus-communis-l-galbulus-pseudo-fructus-revision-1_en.pdf"},
    {"id":"58939","name":"Withdrawal assessment report for Buvidal (II-17)","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-06-14T12:39:00Z","last_updated_date":"2023-06-14T12:39:00Z","reference_number":"EMA/88938/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-buvidal-ii-17_en.pdf"},
    {"id":"58941","name":"Agenda - Clinical Trials Information System Webinar: Second Year of Transition","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-14T14:57:00Z","last_updated_date":"2023-06-14T14:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-clinical-trials-information-system-webinar-second-year-transition_en.pdf"},
    {"id":"58942","name":"Public statement on Nitisinone MDK : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-06-14T14:59:00Z","last_updated_date":"2023-06-14T14:59:00Z","reference_number":"EMA/169031/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-nitisinone-mdk-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"58948","name":"Direct healthcare professional communication (DHPC) :  ADAKVEO (crizanlizumab): revocation of EU marketing authorisation due to lack of therapeutic efficacy","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-06-15T09:00:00Z","last_updated_date":"2023-06-15T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-adakveo-crizanlizumab-revocation-eu-marketing-authorisation-due-lack-therapeutic-efficacy_en.pdf"},
    {"id":"58963","name":"Valsartan / rosuvastatin : List of nationally authorised medicinal products - PSUSA/00010735/202210","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-06-15T14:12:00Z","last_updated_date":"2023-06-15T14:12:00Z","reference_number":"EMA/276650/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/valsartan-rosuvastatin-list-nationally-authorised-medicinal-products-psusa00010735202210_en.pdf"},
    {"id":"58964","name":"Direct healthcare professional communication (DHPC): Gavreto (pralsetinib): Increased risk for tuberculosis and measures to minimise this risk","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-06-16T09:00:00Z","last_updated_date":"2023-06-16T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-gavreto-pralsetinib-increased-risk-tuberculosis-and-measures-minimise-risk_en.pdf"},
    {"id":"58966","name":"Questions and Answers - Union Product Database (UPD) - Volume of Sales webinar for UPD industry users held on 24 April 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-06-15T16:56:00Z","last_updated_date":"2023-06-15T16:56:00Z","reference_number":"EMA/273124/2023","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-union-product-database-upd-volume-sales-webinar-upd-industry-users-held-24-april-2023_en.pdf"},
    {"id":"58967","name":"Ezetimibe : List of nationally authorised medicinal products - PSUSA/00001346/202210","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-06-16T09:20:00Z","last_updated_date":"2023-06-16T09:20:00Z","reference_number":"EMA/275106/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/ezetimibe-list-nationally-authorised-medicinal-products-psusa00001346202210_en.pdf"},
    {"id":"58981","name":"Human medicines highlights - May 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-05-11T16:00:00Z","last_updated_date":"2023-05-11T16:00:00Z","reference_number":"Issue 169","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-may-2023_en.pdf"},
    {"id":"58985","name":"Mandate, objectives and rules of procedure for the Haematology European Specialised Expert Communities (ESEC)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T11:05:00Z","last_updated_date":"2023-06-19T11:05:00Z","reference_number":"EMA/CHMP/BPWP/90503/2023","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-and-rules-procedure-haematology-european-specialised-expert-communities-esec_en.pdf"},
    {"id":"58989","name":"Small and medium-sized enterprise (SME) Office annual report 2022","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T15:22:00Z","last_updated_date":"2023-06-19T15:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/small-and-medium-sized-enterprise-sme-office-annual-report-2022_en.pdf"},
    {"id":"58994","name":"Agenda of the Medicine Shortages (SPOC) Working Party 24 May 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T17:09:00Z","last_updated_date":"2023-07-12T12:21:00Z","reference_number":"EMA/200648/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-24-may-2023_en.pdf"},
    {"id":"58995","name":"Agenda of the Medicine Shortages (SPOC) Working Party meeting 16 June 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T17:17:00Z","last_updated_date":"2023-07-12T12:22:00Z","reference_number":"EMA/251595/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-16-june-2023_en.pdf"},
    {"id":"59008","name":"Agenda - Third European Medicines Agency and Nuclear Medicines Europe bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T09:27:00Z","last_updated_date":"2023-06-21T09:27:00Z","reference_number":"EMA/108752/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-third-european-medicines-agency-and-nuclear-medicines-europe-bilateral-meeting_en.pdf"},
    {"id":"59010","name":"Withdrawal letter : Tidhesco","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T14:01:00Z","last_updated_date":"2023-06-21T14:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-tidhesco_en.pdf"},
    {"id":"59013","name":"Addendum to Assessment report on Ricinus communis L., oleum","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T15:15:00Z","last_updated_date":"2023-06-21T15:15:00Z","reference_number":"EMA/HMPC/883123/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-ricinus-communis-l-oleum_en.pdf"},
    {"id":"59015","name":"Addendum to Assesment report on Sisymbrium officinale (L.) Scop., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T15:20:00Z","last_updated_date":"2023-06-21T15:20:00Z","reference_number":"EMA/HMPC/261330/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assesment-report-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"59027","name":"Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA) 2019-2022","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T11:45:00Z","last_updated_date":"2023-06-22T11:45:00Z","reference_number":"EMA/142695/2023","document_url":"https://www.ema.europa.eu/en/documents/report/report-pharmacovigilance-tasks-eu-member-states-and-european-medicines-agency-ema-2019-2022_en.pdf"},
    {"id":"59036","name":"CHMP post-authorisation summary of positive opinion for Lonsurf (II-26)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T12:00:00Z","last_updated_date":"2023-06-23T12:00:00Z","reference_number":"EMA/CHMP/263819/2023 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-lonsurf-ii-26_en.pdf"},
    {"id":"59037","name":"CHMP post-authorisation summary of positive opinion for Jardiance (II-74)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T12:00:00Z","last_updated_date":"2023-06-23T12:00:00Z","reference_number":"EMA/281506/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jardiance-ii-74_en.pdf"},
    {"id":"59039","name":"CHMP post-authorisation summary of positive opinion for Soliris (II-126)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T12:00:00Z","last_updated_date":"2023-06-23T12:00:00Z","reference_number":"EMA/266855/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-soliris-ii-126_en.pdf"},
    {"id":"59041","name":"Real-world evidence framework to support EU regulatory decision-making: Report on the experience gained with regulator-led studies from September 2021 to February 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T14:32:00Z","last_updated_date":"2023-07-19T14:45:00Z","reference_number":"EMA/289699/2023","document_url":"https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-report-experience-gained-regulator-led-studies-september-2021-february-2023_en.pdf"},
    {"id":"59045","name":"CHMP post-authorisation summary of positive opinion for Imjudo (II-01)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T14:52:00Z","last_updated_date":"2023-06-23T14:52:00Z","reference_number":"EMA/CHMP/285608/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imjudo-ii-01_en.pdf"},
    {"id":"59047","name":"CHMP post-authorisation summary of positive opinion for Refixia (II-32)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T12:00:00Z","last_updated_date":"2023-06-23T12:00:00Z","reference_number":"EMA/265277/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-refixia-ii-32_en.pdf"},
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    {"id":"59050","name":"CHMP summary of positive opinion for Jesduvroq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T15:34:00Z","last_updated_date":"2023-07-21T12:53:00Z","reference_number":"EMA/269186/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-jesduvroq_en.pdf"},
    {"id":"59051","name":"CHMP post-authorisation summary of positive opinion for Mircera (II-92)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T15:39:00Z","last_updated_date":"2023-06-23T15:39:00Z","reference_number":"EMA/286712/2023 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-mircera-ii-92_en.pdf"},
    {"id":"59052","name":"CHMP post-authorisation summary of positive opinion for Trodelvy (II-20)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T12:00:00Z","last_updated_date":"2023-06-23T12:00:00Z","reference_number":"EMA/279923/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trodelvy-ii-20_en.pdf"},
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    {"id":"59055","name":"Withdrawal letter: Zefylti","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T16:09:00Z","last_updated_date":"2023-06-23T16:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-zefylti_en.pdf"},
    {"id":"59056","name":"Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-06-22T16:13:00Z","last_updated_date":"2023-06-22T16:13:00Z","reference_number":"EMA/CHMP/356877/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paracetamol-oral-use-immediate-release-formulations-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"59059","name":"Withdrawal letter: Dyrupeg","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T12:00:00Z","last_updated_date":"2023-06-23T12:00:00Z","reference_number":"EMA/274951/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-dyrupeg_en.pdf"},
    {"id":"59061","name":"Overview of comments received on 'Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance' (EMA/CHMP/315234/2014 Rev.2)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T16:51:00Z","last_updated_date":"2023-06-22T16:51:00Z","reference_number":"EMA/CHMP/779867/2022","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-tadalafil-film-coated-tablets-25-mg-5-mg-10-mg-and-20-mg-product-specific-bioequivalence-guidance-emachmp3152342014-rev2_en.pdf"},
    {"id":"59062","name":"Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-06-22T17:01:00Z","last_updated_date":"2023-06-22T17:01:00Z","reference_number":"EMA/CHMP/356876/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ibuprofen-oral-use-immediate-release-formulations-200-800-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"59063","name":"Overview of comments received on 'Ibuprofen oral use immediate release formulations 200–800 mg productspecific bioequivalence guidance' (EMA/CHMP/356876/2017 Rev.1)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T17:03:00Z","last_updated_date":"2023-06-22T17:03:00Z","reference_number":"EMA/CHMP/735541/2022","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ibuprofen-oral-use-immediate-release-formulations-200-800-mg-productspecific-bioequivalence-guidance-emachmp3568762017-rev1_en.pdf"},
    {"id":"59065","name":"Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T10:26:00Z","last_updated_date":"2023-06-23T10:26:00Z","reference_number":"EMA/CVMP/NTWP/179287/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-and-data-requirements-potency-tests-veterinary-cell-based-therapy-products-and-relation-clinical-efficacy_en.pdf"},
    {"id":"59066","name":"Overview of comments received on 'Guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy ' (EMA/CVMP/NTWP/179287/2022)","type":"comments","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T10:29:00Z","last_updated_date":"2023-06-23T10:29:00Z","reference_number":"EMA/NTWP/85029/2023","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-development-and-data-requirements-potency-tests-veterinary-cell-based-therapy-products-and-relation-clinical-efficacy-emacvmpntwp1792872022_en.pdf"},
    {"id":"59067","name":"Letter of Support for Forskolin-Induced Swelling (FIS) Assay: Biomarker for Cystic Fibrosis Transmembrane Conductance Regulator Protein (CFTR)","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T10:29:00Z","last_updated_date":"2023-06-23T10:29:00Z","reference_number":"EMADOC-1700519818-1037383","document_url":"https://www.ema.europa.eu/en/documents/leaflet/letter-support-forskolin-induced-swelling-fis-assay-biomarker-cystic-fibrosis-transmembrane-conductance-regulator-protein-cftr_en.pdf"},
    {"id":"59069","name":"Questions and answers on the guideline on the SPC for VMPs containing antimicrobial substances – antibiotic clinical breakpoints that may be included in section 4.2 of the SPC for generic VMPs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T11:14:00Z","last_updated_date":"2023-07-19T17:37:00Z","reference_number":"EMA/CVMP/AWP/933465/2022 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-guideline-spc-vmps-containing-antimicrobial-substances-antibiotic-clinical-breakpoints-may-be-included-section-42-spc-generic-vmps_en.pdf"},
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    {"id":"59158","name":"Annual accounts: Financial year 2022","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:12:00Z","last_updated_date":"2023-06-30T14:12:00Z","reference_number":"EMA/121236/2023","document_url":"https://www.ema.europa.eu/en/documents/report/annual-accounts-financial-year-2022_en.pdf"},
    {"id":"59159","name":"Overview of comments received on ICH M13A Guideline on bioequivalence for immediate-release solid oral dosage forms","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:22:00Z","last_updated_date":"2023-06-30T14:22:00Z","reference_number":"EMA/CHMP/ICH/953493/2022","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-m13a-guideline-bioequivalence-immediate-release-solid-oral-dosage-forms_en.pdf"},
    {"id":"59160","name":"Presentation - session 1 - Accelerating Clinical Trials in the EU (ACT EU) (Monique Al, HMA-CCMO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:35:00Z","last_updated_date":"2023-06-30T14:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-accelerating-clinical-trials-eu-act-eu-monique-al-hma-ccmo_en.pdf"},
    {"id":"59161","name":"Presentation - Session 1 - Accelerating Clinical Trials in the EU (ACT EU)  (G. Capone, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:39:00Z","last_updated_date":"2023-06-30T14:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-accelerating-clinical-trials-eu-act-eu-g-capone-ema_en.pdf"},
    {"id":"59162","name":"Presentation - Session 1: Panel and audience discussion on CT environment (J. Isla, European Dravet Syndrome Federation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:46:00Z","last_updated_date":"2023-06-30T14:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-panel-and-audience-discussion-ct-environment-j-isla-european-dravet-syndrome-federation_en.pdf"},
    {"id":"59163","name":"Presentation - Session 1: Panel and audience discussion on CT environment (L. D'Apote, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:48:00Z","last_updated_date":"2023-06-30T14:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-panel-and-audience-discussion-ct-environment-l-dapote-efpia_en.pdf"},
    {"id":"59164","name":"Presentation - Session 1: Panel and audience discussion on CT environment (S. Badreh, European Hematology Association)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:50:00Z","last_updated_date":"2023-06-30T14:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-panel-and-audience-discussion-ct-environment-s-badreh-european-hematology-association_en.pdf"},
    {"id":"59165","name":"Presentation - Session 1: Panel and audience discussion on CT environment (S. Gold, Charité Universitätsmedizin Berlin-CTCG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:53:00Z","last_updated_date":"2023-06-30T14:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-panel-and-audience-discussion-ct-environment-s-gold-charite-universitatsmedizin-berlin-ctcg_en.pdf"},
    {"id":"59166","name":"Presentation - Session 1: ACRO Panel discussion topics (Z. Thacker, ACRO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:55:00Z","last_updated_date":"2023-06-30T14:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-acro-panel-discussion-topics-z-thacker-acro_en.pdf"},
    {"id":"59167","name":"Presentation - Session 2: Clinical Trial Regulation and implementation update (C. Didion, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T14:58:00Z","last_updated_date":"2023-06-30T14:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-clinical-trial-regulation-and-implementation-update-c-didion-ec_en.pdf"},
    {"id":"59168","name":"Presentation - Session 2: Member States support to the CTR implementation (M. Lunzer, HMA-CTCG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:02:00Z","last_updated_date":"2023-06-30T15:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-member-states-support-ctr-implementation-m-lunzer-hma-ctcg_en.pdf"},
    {"id":"59169","name":"Presentation - Session 2: Panel and audience discussion on CTR (A. Michon, ECRIN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:06:00Z","last_updated_date":"2023-06-30T15:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ctr-michon-ecrin_en.pdf"},
    {"id":"59170","name":"Presentation - Session 2: Panel and audience discussion on CTR (D. Johnston, ACRO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:21:00Z","last_updated_date":"2023-06-30T15:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ctr-d-johnston-acro_en.pdf"},
    {"id":"59171","name":"Presentation - Session 2: Panel and audience discussion on CTR (J. Isla, European Dravet Syndrome Federation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:22:00Z","last_updated_date":"2023-06-30T15:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ctr-j-isla-european-dravet-syndrome-federation_en.pdf"},
    {"id":"59172","name":"Presentation - Session 2: Panel and audience discussion on ethics (D. Lo, EATRIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:23:00Z","last_updated_date":"2023-06-30T15:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ethics-d-lo-eatris_en.pdf"},
    {"id":"59173","name":"Presentation - Session 2: Panel and audience discussion on ethics (F. Greenhalgh, EATG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:25:00Z","last_updated_date":"2023-06-30T15:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ethics-f-greenhalgh-eatg_en.pdf"},
    {"id":"59174","name":"Presentation - Session 2: Panel and audience discussion on ethics (M. Carson, REK KULMU, Norwegian ethics committee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:26:00Z","last_updated_date":"2023-06-30T15:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ethics-m-carson-rek-kulmu-norwegian-ethics-committee_en.pdf"},
    {"id":"59175","name":"Presentation - Session 2: Panel and audience discussion on ethics (M. Zwaan, NVMETC, Dutch ethics committee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:28:00Z","last_updated_date":"2023-06-30T15:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ethics-m-zwaan-nvmetc-dutch-ethics-committee_en.pdf"},
    {"id":"59176","name":"Presentation - Session 2: panel and audience discussion on ethics (R. Stanbrook, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:29:00Z","last_updated_date":"2023-06-30T15:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ethics-r-stanbrook-efpia_en.pdf"},
    {"id":"59177","name":"Presentation - Session 2: Panel and audience discussion on ethics - Wolfgang Berdel (AKEK, German ethics committee member)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T15:31:00Z","last_updated_date":"2023-06-30T15:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-ethics-wolfgang-berdel-akek-german-ethics-committee-member_en.pdf"},
    {"id":"59179","name":"Presentation - Session 2: Panel and audience discussion on transparency (D. Navarro Llobet, Spanish Network for Clinical Research)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T16:46:00Z","last_updated_date":"2023-06-30T16:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-transparency-d-navarro-llobet-spanish-network-clinical-research_en.pdf"},
    {"id":"59180","name":"Presentation - Session 2: panel and audience discussion on transparency (J. Holtzople, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T16:48:00Z","last_updated_date":"2023-06-30T16:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-transparency-j-holtzople-efpia_en.pdf"},
    {"id":"59181","name":"Presentation - Session 2: Panel and audience discussion on transparency (R. Castro, EPHA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T16:49:00Z","last_updated_date":"2023-06-30T16:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-transparency-r-castro-epha_en.pdf"},
    {"id":"59182","name":"Presentation - Session 2 - Panel and audience discussion on transparency  (Z. Thacker ,ACRO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T16:51:00Z","last_updated_date":"2023-06-30T16:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-and-audience-discussion-transparency-z-thacker-acro_en.pdf"},
    {"id":"59183","name":"Presentation - Session 2: The role of ethics committees in clinical trials (H. Christiansen, DKETIK, Danish Centre for Ethics)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T16:53:00Z","last_updated_date":"2023-06-30T16:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-role-ethics-committees-clinical-trials-h-christiansen-dketik-danish-centre-ethics_en.pdf"},
    {"id":"59184","name":"Presentation - Session 2: Transparency of clinical trials (L. Pioppo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-30T16:57:00Z","last_updated_date":"2023-06-30T16:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-transparency-clinical-trials-l-pioppo-ema_en.pdf"},
    {"id":"59186","name":"Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T11:39:00Z","last_updated_date":"2023-07-03T11:39:00Z","reference_number":"EMA/250551/2023","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-parallel-emahta-body-htab-scientific-advice-interim-period_en.pdf"},
    {"id":"59188","name":"Presentation - Session 3: Clinical trials in situations of public health emergency (M. Cavaleri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T14:10:00Z","last_updated_date":"2023-07-03T14:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-clinical-trials-situations-public-health-emergency-m-cavaleri-ema_en.pdf"},
    {"id":"59189","name":"Presentation - Session 3: Optimising the EU infrastructure for methodology guidance (F. Lasch, EMA) and (D. Zerlang Andersson, HMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T14:11:00Z","last_updated_date":"2023-07-03T14:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-optimising-eu-infrastructure-methodology-guidance-f-lasch-ema-and-d-zerlang-andersson-hma_en.pdf"},
    {"id":"59190","name":"Presentation - Session 3: Panel and audience discussion on non-commercial CTs (A. Michon, ECRIN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T14:27:00Z","last_updated_date":"2023-07-03T14:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-and-audience-discussion-non-commercial-cts-michon-ecrin_en.pdf"},
    {"id":"59191","name":"Presentation - Session 3: Panel and audience discussion on non-commercial CTs (D. Lacombe, EORTC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T14:28:00Z","last_updated_date":"2023-07-03T14:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-and-audience-discussion-non-commercial-cts-d-lacombe-eortc_en.pdf"},
    {"id":"59195","name":"Presentation - Session 3: Panel and audience discussion on non-commercial CTs (D. Navarro Llobet, Spanish Network for Clinical Research)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T16:24:00Z","last_updated_date":"2023-07-03T16:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-and-audience-discussion-non-commercial-cts-d-navarro-llobet-spanish-network-clinical-research_en.pdf"},
    {"id":"59196","name":"Presentation - Session 3: Panel and audience discussion on non-commercial CTs (D. Lo, EATRIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T16:26:00Z","last_updated_date":"2023-07-03T16:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-and-audience-discussion-non-commercial-cts-d-lo-eatris_en.pdf"},
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    {"id":"59198","name":"Presentation - Session 3 - Panel and audience discussion on non-commercial CTs (M. de Lemus, SMA Europe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-03T16:29:00Z","last_updated_date":"2023-07-03T16:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-and-audience-discussion-non-commercial-cts-m-de-lemus-sma-europe_en.pdf"},
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    {"id":"59222","name":"Presentation - Satisfaction survey - PCO engagement with EMA (G. Gabrielli, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T10:15:00Z","last_updated_date":"2023-07-05T10:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-satisfaction-survey-pco-engagement-ema-g-gabrielli-ema_en.pdf"},
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    {"id":"59227","name":"Presentation - Where is science, technology and medicines regulation heading to? (A. Humphreys, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T10:54:00Z","last_updated_date":"2023-07-05T10:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-where-science-technology-and-medicines-regulation-heading-humphreys-ema_en.pdf"},
    {"id":"59228","name":"Presentation - The importance of stakeholders’ engagement to support implementation of the European Medicines Agencies Network Strategy (J. Garcia Burgos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T11:03:00Z","last_updated_date":"2023-07-05T11:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-importance-stakeholders-engagement-support-implementation-european-medicines-agencies-network-strategy-j-garcia-burgos-ema_en.pdf"},
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    {"id":"59230","name":"Presentation - EMA’s framework of engagement with healthcare professionals and their organisations (I. Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T11:59:00Z","last_updated_date":"2023-07-05T11:59:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-framework-engagement-healthcare-professionals-and-their-organisations-i-silva-ema_en.pdf"},
    {"id":"59231","name":"Presentation - Update on RWE including DARWIN EU (A. Segec, K. Plueschke, D. Umuhire, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:09:00Z","last_updated_date":"2023-07-05T12:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-rwe-including-darwin-eu-segec-k-plueschke-d-umuhire-ema_en.pdf"},
    {"id":"59232","name":"Presentation - Piloting creation of electronic product information (ePI) for EU medicines (E. Scanlan, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:12:00Z","last_updated_date":"2023-07-05T12:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-piloting-creation-electronic-product-information-epi-eu-medicines-e-scanlan-ema_en.pdf"},
    {"id":"59233","name":"Presentation - Monitoring of events and preparedness for public health emergencies / major events (M. Dias, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:13:00Z","last_updated_date":"2023-07-05T12:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-monitoring-events-and-preparedness-public-health-emergencies-major-events-m-dias-ema_en.pdf"},
    {"id":"59234","name":"Presentation - Pilot on reporting of shortages by eligible patients and healthcare professional organisations (I. Abed, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:16:00Z","last_updated_date":"2023-07-05T12:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pilot-reporting-shortages-eligible-patients-and-healthcare-professional-organisations-i-abed-ema_en.pdf"},
    {"id":"59235","name":"Presentation - Implementation of the Good practice guide on prevention of shortages (I. Abed, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:17:00Z","last_updated_date":"2023-07-05T12:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-good-practice-guide-prevention-shortages-i-abed-ema_en.pdf"},
    {"id":"59236","name":"Presentation - Update on activities linked to presence of N-nitrosamines in human medicines (A. Azevado, R. Ruepp, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:20:00Z","last_updated_date":"2023-07-05T12:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-activities-linked-presence-n-nitrosamines-human-medicines-azevado-r-ruepp-ema_en.pdf"},
    {"id":"59237","name":"Presentation - Patient Experience Data (PED) - Update on progress (R. Gonzalez-Quevedo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:22:00Z","last_updated_date":"2023-07-05T12:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-ped-update-progress-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"59238","name":"Presentation - Report on pharmacovigilance tasks of the EU Member States and EMA, 2019-2022 (A. Santoro, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:24:00Z","last_updated_date":"2023-07-05T12:24:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-report-pharmacovigilance-tasks-eu-member-states-and-ema-2019-2022-santoro-ema_en.pdf"},
    {"id":"59239","name":"Presentation - ACT EU - Feedback from kick-off meeting of Multi-Stakeholder Platform (P. Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:26:00Z","last_updated_date":"2023-07-05T12:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-act-eu-feedback-kick-meeting-multi-stakeholder-platform-p-arlett-ema_en.pdf"},
    {"id":"59240","name":"Presentation - EU Recommendations on Decentralised Elements in Clinical Trials (M. Al, CCMO)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:27:00Z","last_updated_date":"2023-07-05T12:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-recommendations-decentralised-elements-clinical-trials-m-al-ccmo_en.pdf"},
    {"id":"59241","name":"Presentation - Renewal of the Human Medicines highlights newsletter: results of the satisfaction survey (K. Immonen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T12:30:00Z","last_updated_date":"2023-07-05T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-renewal-human-medicines-highlights-newsletter-results-satisfaction-survey-k-immonen-ema_en.pdf"},
    {"id":"59242","name":"Presentation - The EU Pharmaceutical Reform (S. Rafael Almeida, DG SANTE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:09:00Z","last_updated_date":"2023-07-05T13:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-pharmaceutical-reform-s-rafael-almeida-dg-sante_en.pdf"},
    {"id":"59243","name":"Presentation - TEHDAS Data Quality Framework: Excellence in data quality (E. Bernal Delgado, TEHDAS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:11:00Z","last_updated_date":"2023-07-05T13:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-tehdas-data-quality-framework-excellence-data-quality-e-bernal-delgado-tehdas_en.pdf"},
    {"id":"59244","name":"Presentation - EU Data Quality Framework and development of the RWD deep dive (A. Cochino, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:14:00Z","last_updated_date":"2023-07-05T13:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-data-quality-framework-and-development-rwd-deep-dive-cochino-ema_en.pdf"},
    {"id":"59245","name":"Presentation - RWD Data Quality Experience in Finland (P. Rannanheimo, FIMEA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:15:00Z","last_updated_date":"2023-07-05T13:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-data-quality-experience-finland-p-rannanheimo-fimea_en.pdf"},
    {"id":"59246","name":"Presentation - Real World Data (RWD) quality and experience Danish national health registers (S. Knudstrup, K. Holt Nielsen, Danish Health Data Authority)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:17:00Z","last_updated_date":"2023-07-05T13:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-real-world-data-rwd-quality-and-experience-danish-national-health-registers-s-knudstrup-k-holt-nielsen-danish-health-data-authority_en.pdf"},
    {"id":"59247","name":"Presentation - RWD Data Quality Experience in France (E. Bacry, Health Data Hub)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:20:00Z","last_updated_date":"2023-07-05T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-data-quality-experience-france-e-bacry-health-data-hub_en.pdf"},
    {"id":"59248","name":"Presentation – RWD Data Quality Experience by Industry (K.H. Zou, Viatris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:21:00Z","last_updated_date":"2023-07-05T13:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-data-quality-experience-industry-kh-zou-viatris_en.pdf"},
    {"id":"59249","name":"Presentation - Systems and processes underpinning Real-World Data : Characterisation and maturity model consideration (A. Cochino, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:23:00Z","last_updated_date":"2023-07-05T13:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-systems-and-processes-underpinning-real-world-data-characterisation-and-maturity-model-consideration-cochino-ema_en.pdf"},
    {"id":"59250","name":"Presentation - Data quality metrics in the context of DARWIN EU (M. Moinat, DARWIN EU Coordinating Centre)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:25:00Z","last_updated_date":"2023-07-05T13:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-quality-metrics-context-darwin-eu-m-moinat-darwin-eu-coordinating-centre_en.pdf"},
    {"id":"59251","name":"Presentation - Data Quality metrics for Real-World Data (K.Deli, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:26:00Z","last_updated_date":"2023-07-05T13:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-quality-metrics-real-world-data-kdeli-ema_en.pdf"},
    {"id":"59252","name":"Presentation - Data quality requirements and study design and analysis aspects (O. Klungel, Utrecht University)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:27:00Z","last_updated_date":"2023-07-05T13:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-quality-requirements-and-study-design-and-analysis-aspects-o-klungel-utrecht-university_en.pdf"},
    {"id":"59253","name":"Presentation - Data quality in fit for purpose assessments (J. Abellan, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:29:00Z","last_updated_date":"2023-07-05T13:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-quality-fit-purpose-assessments-j-abellan-ema_en.pdf"},
    {"id":"59254","name":"Presentation - A report on the experience with regulatory led RWD studies (S. Prilla, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:30:00Z","last_updated_date":"2023-07-05T13:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-report-experience-regulatory-led-rwd-studies-s-prilla-ema_en.pdf"},
    {"id":"59255","name":"Presentation - Use of RWE in medicines development and regulatory submissions - an industry perspective (A. Spooner, AbbVie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:32:00Z","last_updated_date":"2023-07-05T13:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-rwe-medicines-development-and-regulatory-submissions-industry-perspective-spooner-abbvie_en.pdf"},
    {"id":"59256","name":"Presentation - Use of RWE in medicines development and regulatory submissions - a regulator’s perspective (C. Torre, University of Lisbon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:33:00Z","last_updated_date":"2023-07-10T11:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-rwe-medicines-development-and-regulatory-submissions-regulators-perspective-c-torre-university-lisbon_en.pdf"},
    {"id":"59257","name":"Presentation - Survey results : Use (-fulness) of RWE in regulatory decisions (S. Prilla, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:35:00Z","last_updated_date":"2023-07-05T13:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-results-use-fulness-rwe-regulatory-decisions-s-prilla-ema_en.pdf"},
    {"id":"59258","name":"Presentation - DARWIN EU: where we are in the Phase 2 of its implementation (A. Segec, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:37:00Z","last_updated_date":"2023-07-05T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-darwin-eu-where-we-are-phase-2-its-implementation-segec-ema_en.pdf"},
    {"id":"59259","name":"Presentation - DARWIN EU to support HTA and payers’ research RWE needs (J. Abellan, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:38:00Z","last_updated_date":"2023-07-05T13:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-darwin-eu-support-hta-and-payers-research-rwe-needs-j-abellan-ema_en.pdf"},
    {"id":"59260","name":"Presentation - DARWIN EU to support EHDS2 pilot (M. Jendrossek, EHDS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:39:00Z","last_updated_date":"2023-07-05T13:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-darwin-eu-support-ehds2-pilot-m-jendrossek-ehds_en.pdf"},
    {"id":"59261","name":"Presentation - DARWIN EU in the context of infectious diseases and health emergencies (E. Duffell, ECDC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:42:00Z","last_updated_date":"2023-07-05T13:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-darwin-eu-context-infectious-diseases-and-health-emergencies-e-duffell-ecdc_en.pdf"},
    {"id":"59262","name":"Presentation - Patient registries in regulatory decision making : Regulator’s vision and experiences (P. McGettigan, PRAC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:44:00Z","last_updated_date":"2023-07-05T13:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-registries-regulatory-decision-making-regulators-vision-and-experiences-p-mcgettigan-prac_en.pdf"},
    {"id":"59263","name":"Presentation - Assessing the EMA data quality framework (DQF) dimensions using REQUeST: a decentralized registry use case (P. Dobay, Meritxell Sabidó)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:46:00Z","last_updated_date":"2023-07-05T13:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-assessing-ema-data-quality-framework-dqf-dimensions-using-request-decentralized-registry-use-case-p-dobay-meritxell-sabido_en.pdf"},
    {"id":"59264","name":"Presentation - Registry based randomized clinical trials (R-RCT) - from SWEDEHEART to EuroHeart (L. Wallentin, Uppsala University)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:48:00Z","last_updated_date":"2023-07-05T13:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-registry-based-randomized-clinical-trials-r-rct-swedeheart-euroheart-l-wallentin-uppsala-university_en.pdf"},
    {"id":"59265","name":"Presentation - Survey results on the EMA guideline on registry based studies (K. Plueschke, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:49:00Z","last_updated_date":"2023-07-05T13:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-results-ema-guideline-registry-based-studies-k-plueschke-ema_en.pdf"},
    {"id":"59266","name":"Presentation - Patient representative perspective - panel discussion (M. De Lemus, CAT)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:51:00Z","last_updated_date":"2023-07-05T13:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-representative-perspective-panel-discussion-m-de-lemus-cat_en.pdf"},
    {"id":"59267","name":"Presentation - Measuring vaccine performance under emergency situations - case studies and learnings for RWE generation (M. Goossens, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T13:53:00Z","last_updated_date":"2023-07-05T13:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-measuring-vaccine-performance-under-emergency-situations-case-studies-and-learnings-rwe-generation-m-goossens-ema_en.pdf"},
    {"id":"59271","name":"CTIS newsflash – 23 June 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-07-05T17:22:00Z","last_updated_date":"2023-07-05T17:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-23-june-2023_en.pdf"},
    {"id":"59276","name":"Polystyrene sulfonate : List of nationally authorised medicinal products - PSUSA/00002472/202210","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-07-06T14:09:00Z","last_updated_date":"2023-07-06T14:09:00Z","reference_number":"EMA/313560/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/polystyrene-sulfonate-list-nationally-authorised-medicinal-products-psusa00002472202210_en.pdf"},
    {"id":"59277","name":"Polystyrene sulfonate : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"59306","name":"Withdrawal assessment report for Asimtufii","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-07-07T16:24:00Z","last_updated_date":"2023-07-07T16:24:00Z","reference_number":"EMA/CHMP/231170/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-asimtufii_en.pdf"},
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    {"id":"59308","name":"Concept paper on the need for revision of the Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-07-07T17:35:00Z","last_updated_date":"2023-07-07T17:35:00Z","reference_number":"EMA/CHMP/264860/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
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    {"id":"59311","name":"Public statement on Lenalidomide Krka d.d. : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-07-10T15:40:00Z","last_updated_date":"2023-07-10T15:40:00Z","reference_number":"EMA/294651/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-lenalidomide-krka-dd-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"59338","name":"Sodium fluoride (18F) : List of nationally authorised medicinal products - PSUSA/00010706/202211","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-07-12T11:51:00Z","last_updated_date":"2023-07-12T11:51:00Z","reference_number":"EMA/275473/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-fluoride-18f-list-nationally-authorised-medicinal-products-psusa00010706202211_en.pdf"},
    {"id":"59339","name":"Agenda of the Medicine Shortages (SPOC) Working Party 6 July 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-07-12T12:29:00Z","last_updated_date":"2023-07-12T12:29:00Z","reference_number":"EMA/293652/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-6-july-2023_en.pdf"},
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    {"id":"59343","name":"Anniversary messages from HCPWP members","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-07-12T17:54:00Z","last_updated_date":"2023-07-12T17:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/anniversary-messages-hcpwp-members_en.pdf"},
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    {"id":"59353","name":"Agenda - Fourth EMA-AESGP bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-07-13T17:41:00Z","last_updated_date":"2023-07-13T17:41:00Z","reference_number":"EMA/157813/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fourth-ema-aesgp-bilateral-meeting_en.pdf"},
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    {"id":"59362","name":"Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products on the availability of a subset of antibiotics","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2023-07-17T10:12:00Z","last_updated_date":"2023-07-17T10:12:00Z","reference_number":"EMA/312229/2023","document_url":"https://www.ema.europa.eu/en/documents/other/recommendations-executive-steering-group-shortages-and-safety-medicinal-products-availability-subset-antibiotics_en.pdf"},
    {"id":"59388","name":"Bromperidol: List of nationally authorised medicinal products - PSUSA/00000439/202211","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-07-18T16:14:00Z","last_updated_date":"2023-07-18T16:14:00Z","reference_number":"EMA/328244/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/bromperidol-list-nationally-authorised-medicinal-products-psusa00000439202211_en.pdf"},
    {"id":"59389","name":"Amlodipine / indapamide, amlodipine / indapamide / perindopril: List of nationally authorised medicinal products - PSUSA/00010358/202211","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-07-18T16:25:00Z","last_updated_date":"2023-07-18T16:25:00Z","reference_number":"EMA/327585/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-indapamide-amlodipine-indapamide-perindopril-list-nationally-authorised-medicinal-products-psusa00010358202211_en.pdf"},
    {"id":"59390","name":"Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009182/202212","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-07-18T16:28:00Z","last_updated_date":"2023-07-18T16:28:00Z","reference_number":"EMA/327388/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxycarbamide-except-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa00009182202212_en.pdf"},
    {"id":"59392","name":"Withdrawal assessment report for Susvimo","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-07-18T13:55:00Z","last_updated_date":"2023-07-18T13:55:00Z","reference_number":"EMA/206018/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-susvimo_en.pdf"},
    {"id":"59398","name":"Withdrawal letter: Jesduvroq","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-jesduvroq_en.pdf"},
    {"id":"59403","name":"ICH M7(R2) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-07-19T17:00:00Z","last_updated_date":"2023-07-19T17:00:00Z","reference_number":"EMA/CHMP/ICH/502766/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m7r2-addendum-application-principles-ich-m7-guideline-calculation-compound-specific-acceptable-intakes-step-5_en.pdf"},
    {"id":"59405","name":"CHMP summary of positive opinion for Lyfnua","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T16:07:00Z","last_updated_date":"2023-07-21T16:07:00Z","reference_number":"EMA/CHMP/322106/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lyfnua_en.pdf"},
    {"id":"59407","name":"CHMP summary of positive opinion for Orserdu","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T16:21:00Z","last_updated_date":"2023-07-21T16:21:00Z","reference_number":"EMA/CHMP/325146/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-orserdu_en.pdf"},
    {"id":"59409","name":"CHMP summary of positive opinion for Litfulo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/CHMP/328223/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-litfulo_en.pdf"},
    {"id":"59410","name":"CHMP post-authorisation summary of positive opinion for Ervebo (II-25)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T16:40:00Z","last_updated_date":"2023-07-21T16:40:00Z","reference_number":"EMA/CHMP/189667/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ervebo-ii-25_en.pdf"},
    {"id":"59411","name":"ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-07-19T16:53:00Z","last_updated_date":"2023-07-19T16:53:00Z","reference_number":"EMA/CHMP/ICH/83812/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m7r2-guideline-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-step-5_en.pdf"},
    {"id":"59413","name":"Withdrawal letter: Gefzuris","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T18:03:00Z","last_updated_date":"2023-07-21T18:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-gefzuris_en.pdf"},
    {"id":"59415","name":"CHMP post-authorisation summary of positive opinion for Keytruda (II-133)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T09:24:00Z","last_updated_date":"2023-07-21T09:24:00Z","reference_number":"EMA/CHMP/287639/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-133_en.pdf"},
    {"id":"59417","name":"CHMP summary of positive opinion for Abrysvo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/CHMP/327338/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-abrysvo_en.pdf"},
    {"id":"59418","name":"Agenda - Tenth industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:20:00Z","last_updated_date":"2023-07-20T11:20:00Z","reference_number":"EMA/168978/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-tenth-industry-stakeholder-platform-research-and-development-support_en.pdf"},
    {"id":"59419","name":"Presentation - Update on latest developments in scientific advice (I.Gravanis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-latest-developments-scientific-advice-igravanis-ema_en.pdf"},
    {"id":"59420","name":"Presentation - PRIME: Implementation of new initiatives to further strengthen the PRIME scheme (K. Cunningham, A. Gross, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prime-implementation-new-initiatives-further-strengthen-prime-scheme-k-cunningham-gross-ema_en.pdf"},
    {"id":"59421","name":"Presentation - EMA multistakeholder workshop on Qualification of Novel Methodologies (QoNM) - initial feedback from the discussions (T. Vetter, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-multistakeholder-workshop-qualification-novel-methodologies-qonm-initial-feedback-discussions-t-vetter-ema_en.pdf"},
    {"id":"59422","name":"Presentation - Cooperation at the HTA/regulatory interface (S.Said, G-BA; T.Olski, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cooperation-htaregulatory-interface-ssaid-g-ba-tolski-ema_en.pdf"},
    {"id":"59423","name":"Presentation - Experience from sPIP pilot (C, Pallidis, S. Scherer, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-spip-pilot-c-pallidis-s-scherer-ema_en.pdf"},
    {"id":"59424","name":"Presentation - Revision of the key elements and the summary report template (R. De Lisa, C. Pallidis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revision-key-elements-and-summary-report-template-r-de-lisa-c-pallidis-ema_en.pdf"},
    {"id":"59425","name":"Presentation - Proposals moving forward to facilitate the scientific dialogue on drug-device and drug-companion diagnostic combinations within the current regulatory framework and potentially in the future (S. Aarum, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-20T11:21:00Z","last_updated_date":"2023-07-20T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposals-moving-forward-facilitate-scientific-dialogue-drug-device-and-drug-companion-diagnostic-combinations-within-current-regulatory-framework-and-potentially-future-s-aarum-ema_en.pdf"},
    {"id":"59426","name":"CHMP post-authorisation summary of positive opinion for Opdivo (II-130)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/CHMP/292683/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-opdivo-ii-130_en.pdf"},
    {"id":"59427","name":"CHMP summary of positive opinion for Inaqovi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T11:51:00Z","last_updated_date":"2023-07-21T11:51:00Z","reference_number":"EMA/324132/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-inaqovi_en.pdf"},
    {"id":"59428","name":"CHMP summary of positive opinion for Yesafili","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T11:56:00Z","last_updated_date":"2023-07-21T11:56:00Z","reference_number":"EMA/CHMP/299233/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-yesafili_en.pdf"},
    {"id":"59429","name":"CHMP summary of positive opinion for Apretude","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:01:00Z","last_updated_date":"2023-07-21T12:01:00Z","reference_number":"EMA/327881/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-apretude_en.pdf"},
    {"id":"59430","name":"Questions and answers on the refusal of the marketing authorisation for Krazati (adagrasib)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-28T17:06:00Z","reference_number":"EMA/333057/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-and-answers-refusal-marketing-authorisation-krazati-adagrasib_en.pdf"},
    {"id":"59432","name":"CHMP summary of positive opinion for Talvey","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-20T14:59:00Z","last_updated_date":"2023-07-20T14:59:00Z","reference_number":"EMA/323969/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-talvey_en.pdf"},
    {"id":"59433","name":"CHMP summary of positive opinion for Enrylaze","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T15:04:00Z","last_updated_date":"2023-07-21T15:04:00Z","reference_number":"EMA/323951/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-enrylaze_en.pdf"},
    {"id":"59436","name":"Synapse Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T15:39:00Z","last_updated_date":"2023-07-21T15:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/synapse-article-31-referral-notification_en.pdf"},
    {"id":"59437","name":"Synapse Article-31 referral - CHMP list of questions to be addressed by applicants and marketing authorisation holders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T15:39:00Z","last_updated_date":"2023-07-21T15:39:00Z","reference_number":"EMA/CHMP/304426/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/synapse-article-31-referral-chmp-list-questions-be-addressed-applicants-and-marketing-authorisation-holders_en.pdf"},
    {"id":"59438","name":"Synapse Article-31 referral - CHMP list of questions to be addressed by Synapse Labs located in Kharadi","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T15:41:00Z","last_updated_date":"2023-07-21T15:41:00Z","reference_number":"EMA/CHMP/304427/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/synapse-article-31-referral-chmp-list-questions-be-addressed-synapse-labs-located-kharadi_en.pdf"},
    {"id":"59440","name":"CHMP summary of opinion for Tevimbra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/CHMP/321765/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-tevimbra_en.pdf"},
    {"id":"59441","name":"CHMP post-authorisation summary of positive opinion for Bylvay (II-11 )","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T16:40:00Z","last_updated_date":"2023-07-21T16:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-bylvay-ii-11_en.pdf"},
    {"id":"59442","name":"CHMP post-authorisation summary of opinion for Olumiant (X-35-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/CHMP/311719/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-opinion-olumiant-x-35-g_en.pdf"},
    {"id":"59444","name":"CHMP summary of positive opinion for Tepkinly","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T17:16:00Z","last_updated_date":"2023-07-21T17:16:00Z","reference_number":"EMA/CHMP/324066/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tepkinly_en.pdf"},
    {"id":"59445","name":"CHMP summary of positive opinion for Tyenne","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/245419/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-tyenne_en.pdf"},
    {"id":"59449","name":"CHMP post-authorisation summary of positive opinion for Evrysdi","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T10:40:00Z","last_updated_date":"2023-07-21T10:40:00Z","reference_number":"EMA/CHMP/807714/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-evrysdi_en.pdf"},
    {"id":"59452","name":"CHMP post-authorisation summary of positive opinion for Spikevax (II-104-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:51:00Z","last_updated_date":"2023-07-21T12:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-spikevax-ii-104-g_en.pdf"},
    {"id":"59453","name":"Guideline on excipients in the dossier for application for marketing authorisation for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T13:34:00Z","last_updated_date":"2023-07-21T13:34:00Z","reference_number":"EMA/CVMP/QWP/307647/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-excipients-dossier-application-marketing-authorisation-veterinary-medicinal-products_en.pdf"},
    {"id":"59457","name":"Start of Union reviews adopted during the CHMP meeting of 17-20 July 2023","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T16:05:00Z","last_updated_date":"2023-07-21T16:05:00Z","reference_number":"EMA/232911/2023","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-union-reviews-adopted-during-chmp-meeting-17-20-july-2023_en.pdf"},
    {"id":"59459","name":"Guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T16:33:00Z","last_updated_date":"2023-07-21T16:33:00Z","reference_number":"EMA/CVMP/IWP/170689/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-production-and-control-safety-and-efficacy-allergen-products-use-horses-dogs-and-cats_en.pdf"},
    {"id":"59460","name":"Overview of comments received on 'Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats'","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T16:37:00Z","last_updated_date":"2023-07-21T16:37:00Z","reference_number":"EMA/CVMP/IWP/530940/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-draft-guideline-requirements-quality-production-and-control-safety-and-efficacy-allergen-products-use-horses-dogs-and-cats_en.pdf"},
    {"id":"59465","name":"Highlights - Second European Medicines Agency & MedTech Europe bilateral meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-07-21T17:39:00Z","last_updated_date":"2023-07-21T17:39:00Z","reference_number":"EMA/157298/2023","document_url":"https://www.ema.europa.eu/en/documents/minutes/highlights-second-european-medicines-agency-medtech-europe-bilateral-meeting_en.pdf"},
    {"id":"59466","name":"CTIS newsflash - 21 July 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-07-24T11:06:00Z","last_updated_date":"2023-07-24T11:06:00Z","reference_number":"EMA/293653/2023","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-21-july-2023_en.pdf"},
    {"id":"59468","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - November 2022","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-07-24T13:55:00Z","last_updated_date":"2023-07-24T13:55:00Z","reference_number":"EMA/908798/2022","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-november-2022_en.pdf"},
    {"id":"59469","name":"Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - March 2023","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-07-24T13:56:00Z","last_updated_date":"2023-07-24T13:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-european-medicines-agencyeuropean-network-health-technology-assessment-meeting-march-2023_en.pdf"},
    {"id":"59470","name":"Agenda - Enpr-EMA Coordinating Group and networks meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-07-24T14:05:00Z","last_updated_date":"2023-07-24T14:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-enpr-ema-coordinating-group-and-networks-meeting_en.pdf-0"},
    {"id":"59471","name":"Minutes - Enpr-EMA Coordinating Group and networks meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-07-24T14:07:00Z","last_updated_date":"2023-08-02T09:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-enpr-ema-coordinating-group-and-networks-meeting_en.pdf-0"},
    {"id":"59483","name":"Presentation - Setting the scene on the current regulatory framework (I. Clamou, European Commission)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:19:00Z","last_updated_date":"2023-07-25T13:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-setting-scene-current-regulatory-framework-i-clamou-european-commission_en.pdf"},
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    {"id":"59485","name":"Presentation - Role of EMA Emergency Task Force (M. Mura, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:26:00Z","last_updated_date":"2023-07-25T13:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-ema-emergency-task-force-m-mura-ema_en.pdf"},
    {"id":"59486","name":"Presentation - Past-Experience MOSAIC, EU-RESPONSE (Y. Yazdanpanah, I.C. Olsen, P. Olliario (MOSAIC & EU-Solidact)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:27:00Z","last_updated_date":"2023-07-25T13:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-past-experience-mosaic-eu-response-y-yazdanpanah-ic-olsen-p-olliario-mosaic-eu-solidact_en.pdf"},
    {"id":"59487","name":"Presentation - Past-Experience STRIVE (J. Lundgren, University of Copenhagen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:29:00Z","last_updated_date":"2023-07-25T13:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-past-experience-strive-j-lundgren-university-copenhagen_en.pdf"},
    {"id":"59488","name":"Presentation - Current efforts for clinical research in preparedness and during emergencies in the EU (I. Norstedt, DG R&I)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:32:00Z","last_updated_date":"2023-07-25T13:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-efforts-clinical-research-preparedness-and-during-emergencies-eu-i-norstedt-dg-ri_en.pdf"},
    {"id":"59489","name":"Presentation - Current efforts for clinical research in preparedness and during emergencies in the EU (L. Muschel, European Commission)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:33:00Z","last_updated_date":"2023-07-25T13:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-efforts-clinical-research-preparedness-and-during-emergencies-eu-l-muschel-european-commission_en.pdf"},
    {"id":"59490","name":"Presentation - Pandemic Preparedness Partnership (H. Raoul, Be Ready)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:34:00Z","last_updated_date":"2023-07-25T13:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pandemic-preparedness-partnership-h-raoul-be-ready_en.pdf"},
    {"id":"59491","name":"Presentation - Coordination of trials (V. Simensen, J. Arne, NIPH)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:37:00Z","last_updated_date":"2023-07-25T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-coordination-trials-v-simensen-j-arne-niph_en.pdf"},
    {"id":"59492","name":"Presentation - JAAM (J. Demotes, ECRIN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:40:00Z","last_updated_date":"2023-07-25T13:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-jaam-j-demotes-ecrin_en.pdf"},
    {"id":"59493","name":"Presentation - Experience from clinical trials MonkeyVax (L. Binh Luong)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:41:00Z","last_updated_date":"2023-07-25T13:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-experience-clinical-trials-monkeyvax-l-binh-luong_en.pdf"},
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    {"id":"59496","name":"Report of the EMA/ETF workshop on Lessons Learned on Clinical  Trials in Public Health Emergencies","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T14:00:00Z","last_updated_date":"2023-07-25T14:00:00Z","reference_number":"EMA/340269/2023","document_url":"https://www.ema.europa.eu/en/documents/report/report-emaetf-workshop-lessons-learned-clinical-trials-public-health-emergencies_en.pdf"},
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    {"id":"59498","name":"Agenda - Lessons-learned workshop on Clinical Trials in Public Health Emergencies","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-07-25T13:52:00Z","last_updated_date":"2023-07-25T13:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-lessons-learned-workshop-clinical-trials-public-health-emergencies_en.pdf"},
    {"id":"59503","name":"News bulletin for small and medium-sized enterprises - Issue 59","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-07-26T10:45:00Z","last_updated_date":"2023-07-26T10:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/news-bulletin-small-and-medium-sized-enterprises-issue-59_en.pdf"},
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    {"id":"59511","name":"Highlight report 10th Meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-07-27T16:17:00Z","last_updated_date":"2023-07-27T16:17:00Z","reference_number":"EMA/298697/2023","document_url":"https://www.ema.europa.eu/en/documents/report/highlight-report-10th-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicines_en.pdf"},
    {"id":"59528","name":"Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy studies","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-07-31T12:29:00Z","last_updated_date":"2023-07-31T12:29:00Z","reference_number":"EMADOC-1700519818-1127132","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/qualification-opinion-stride-velocity-95th-centile-primary-endpoint-studies-ambulatory-duchenne-muscular-dystrophy-studies_en.pdf"},
    {"id":"59532","name":"Addendum to Assessment report on Capsicum annuum L. var. minimum (Miller) Heiser, fructus","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-07-31T15:03:00Z","last_updated_date":"2023-07-31T15:03:00Z","reference_number":"EMA/HMPC/104943/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-capsicum-annuum-l-var-minimum-miller-heiser-fructus_en.pdf"},
    {"id":"59537","name":"Addendum to Assessment report on Melaleuca alternifolia (Maiden and Betche) Cheel; Melaleuca linariifolia Smith; Melaleuca dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-08-02T13:52:00Z","last_updated_date":"2023-08-02T13:52:00Z","reference_number":"EMA/HMPC/765808/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-melaleuca-alternifolia-maiden-and-betche-cheel-melaleuca-linariifolia-smith-melaleuca-dissitiflora-f-mueller-andor-other-species-melaleuca-aetheroleum_en.pdf"},
    {"id":"59540","name":"Addendum to assessment report on Origanum majorana L., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2023-08-02T16:11:00Z","last_updated_date":"2023-08-02T16:11:00Z","reference_number":"EMA/HMPC/765801/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-origanum-majorana-l-herba_en.pdf"},
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    {"id":"59553","name":"Public statement on Busilvex : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-08-04T13:01:00Z","last_updated_date":"2023-08-04T13:01:00Z","reference_number":"EMA/948441/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-busilvex-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"59577","name":"Adakveo Article-20 procedure - Assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-08-09T15:20:00Z","last_updated_date":"2023-08-21T13:49:00Z","reference_number":"EMA/267688/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/adakveo-article-20-procedure-assessment-report_en.pdf"},
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    {"id":"59585","name":"Direct healthcare professional communication (DHPC): Simponi (golimumab) 50 mg and 100 mg: important changes to the injection instructions for the SmartJect Pre-filled Pen","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-08-10T16:56:00Z","last_updated_date":"2023-08-10T16:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-simponi-golimumab-50-mg-and-100-mg-important-changes-injection-instructions-smartject-pre-filled-pen_en.pdf"},
    {"id":"59595","name":"Human medicines highlights - August 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-08-14T14:44:00Z","last_updated_date":"2023-08-14T14:44:00Z","reference_number":"Issue 172","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-august-2023_en.pdf"},
    {"id":"59601","name":"Agenda of the CHMP written procedure 14-17 August 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-08-14T16:21:00Z","last_updated_date":"2023-08-14T16:21:00Z","reference_number":"EMA/CHMP/362824/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-written-procedure-14-17-august-2023_en.pdf"},
    {"id":"59602","name":"Withdrawal letter: Lutholaz (pegfilgrastim)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-08-17T10:56:00Z","last_updated_date":"2023-08-17T10:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-lutholaz-pegfilgrastim_en.pdf"},
    {"id":"59619","name":"Yellow fever vaccine (live) : List of nationally authorised medicinal products - PSUSA/00003135/202212","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-08-24T12:37:00Z","last_updated_date":"2023-08-24T12:37:00Z","reference_number":"EMA/312009/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/yellow-fever-vaccine-live-list-nationally-authorised-medicinal-products-psusa00003135202212_en.pdf-0"},
    {"id":"59633","name":"Apomorphine : List of nationally authorised medicinal products - PSUSA/00000227/202211","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-08-25T11:45:00Z","last_updated_date":"2023-08-25T11:45:00Z","reference_number":"EMA/384442/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/apomorphine-list-nationally-authorised-medicinal-products-psusa00000227202211_en.pdf"},
    {"id":"59661","name":"Meeting report - Multi-stakeholder Workshop on ICH E6(R3) - Public Consultation - Day one","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-08-29T17:31:00Z","last_updated_date":"2023-08-29T17:31:00Z","reference_number":"EMA/321989/2023","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-multi-stakeholder-workshop-ich-e6r3-public-consultation-day-one_en.pdf"},
    {"id":"59671","name":"When is it relevant to include a bodyweight limit in the wording of a paediatric indication?","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-08-30T12:46:00Z","last_updated_date":"2023-08-30T12:46:00Z","reference_number":"EMA/268908/2023","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/when-it-relevant-include-bodyweight-limit-wording-paediatric-indication_en.pdf"},
    {"id":"59678","name":"Withdrawal assessment report for Zefylti","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-08-30T15:14:00Z","last_updated_date":"2023-08-30T15:14:00Z","reference_number":"EMA/CHMP/596395/2022","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-zefylti_en.pdf"},
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    {"id":"59603","name":"Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-08-17T13:10:00Z","last_updated_date":"2023-08-17T13:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/potential-missing-package-leaflet-folding-boxes-roactemra-tocilizumab-hemlibra-emicizumab-herceptin-trastuzumab-kadcyla-trastuzumab-emtansine-mabthera-rituximab-phesgo-pertuzumab-trastuzumab-and_en.pdf"},
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    {"id":"59877","name":"Allergen for therapy: Dactylis Glomerata L., Phleum Pratense L., Anthoxanthum Odoratum L., Lolium Perenne L., Poa Pratensis L.(sublingual tablet) : List of nationally authorised medicinal products - PSUSA/00010465/202212","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-01T08:55:00Z","last_updated_date":"2023-09-01T08:55:00Z","reference_number":"EMA/395418/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-therapy-dactylis-glomerata-l-phleum-pratense-l-anthoxanthum-odoratum-l-lolium-perenne-l-poa-pratensis-lsublingual-tablet-list-nationally-authorised-medicinal-products-psusa-00010465-202212_en.pdf"},
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    {"id":"59919","name":"CVMP summary of positive opinion for Loxitab","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-09-08T12:00:00Z","last_updated_date":"2023-09-08T12:00:00Z","reference_number":"EMA/CVMP/386093/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-loxitab_en.pdf"},
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    {"id":"59995","name":"Start of Union reviews adopted during the CHMP meeting of 11-14 September 2023","type":"chmp-annex","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T12:00:00Z","last_updated_date":"2023-09-15T12:00:00Z","reference_number":"EMA/351480/2023","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-union-reviews-adopted-during-chmp-meeting-11-14-september-2023_en.pdf"},
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    {"id":"60003","name":"Withdrawal letter: Iclusig (II-64)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T08:48:00Z","last_updated_date":"2023-09-15T08:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawal-letter-iclusig-ii-64_en.pdf"},
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    {"id":"60013","name":"Mysimba Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T10:14:00Z","last_updated_date":"2023-09-15T10:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/mysimba-article-20-procedure-notification_en.pdf"},
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    {"id":"60015","name":"CHMP post-authorisation summary of positive opinion for Keytruda (II-121)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-09-15T12:00:00Z","last_updated_date":"2023-09-15T12:00:00Z","reference_number":"EMA/CHMP/377073/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-121_en.pdf"},
    {"id":"60018","name":"Report on the implementation of the EMA-EUnetHTA 21 work plan 2021 - 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T15:33:00Z","last_updated_date":"2023-09-15T15:33:00Z","reference_number":"EMA/290158/2023","document_url":"https://www.ema.europa.eu/en/documents/report/report-implementation-ema-eunethta-21-work-plan-2021-2023_en.pdf"},
    {"id":"60025","name":"CHMP post-authorisation summary of positive opinion for Adcetris (II-107)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-09-15T11:08:00Z","last_updated_date":"2023-09-15T11:08:00Z","reference_number":"EMA/CHMP/403313/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-adcetris-ii-107_en.pdf"},
    {"id":"60027","name":"CHMP summary of positive opinion for Catiolanze","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T12:20:00Z","last_updated_date":"2023-09-15T12:20:00Z","reference_number":"EMA/CHMP/402547/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-catiolanze_en.pdf"},
    {"id":"60029","name":"CHMP post-authorisation summary of opinion for Enhertu (II-27)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-09-15T12:00:00Z","last_updated_date":"2023-09-15T12:00:00Z","reference_number":"EMA/CHMP/400602/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-opinion-enhertu-ii-27_en.pdf"},
    {"id":"60030","name":"Agenda - PCWP/HCPWP joint meeting (19-20 September 2023)","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-09-15T13:37:00Z","last_updated_date":"2023-09-25T16:05:00Z","reference_number":"EMA/901780/2022","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pcwp-hcpwp-joint-meeting-19-20-september-2023_en.pdf"},
    {"id":"60031","name":"CHMP summary of positive opinion for Zilbrysq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-09-15T14:29:00Z","last_updated_date":"2023-09-15T14:29:00Z","reference_number":"EMA/CHMP/404478/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zilbrysq_en.pdf"},
    {"id":"60034","name":"CTIS newsflash - 15 September 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T16:16:00Z","last_updated_date":"2023-09-15T16:16:00Z","reference_number":"EMA/397022/2023","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-15-september-2023_en.pdf"},
    {"id":"60044","name":"Agenda - EU Network Training Centre: Oncology pilot educational program for external experts","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-18T14:19:00Z","last_updated_date":"2023-09-18T14:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eu-network-training-centre-oncology-pilot-educational-program-external-experts_en.pdf"},
    {"id":"60053","name":"Draft agenda – 6th Industry Standing Group (ISG) meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-18T16:22:00Z","last_updated_date":"2023-09-18T16:22:00Z","reference_number":"EMA/269763/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-6th-industry-standing-group-isg-meeting_en.pdf"},
    {"id":"60068","name":"Agenda of the Medicine Shortages (SPOC) Working Party meeting 12 September 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-20T08:25:00Z","last_updated_date":"2023-09-20T08:25:00Z","reference_number":"EMA/346780/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-12-september-2023_en.pdf"},
    {"id":"60070","name":"Calcium chloride dihydrate/magnesium chloride hexahydrate/malic acid/sodium acetate trihydrate/sodium chloride....potassium chloride : List of nationally authorised medicinal products - PSUSA/00010622/202301","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-20T10:20:00Z","last_updated_date":"2023-09-20T10:20:00Z","reference_number":"EMA/38225/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-chloride-dihydrate-magnesium-chloride-hexahydrate-malic-acid-sodium-acetate-trihydrate-sodium-chloridepotassium-chloride-list-nationally-authorised-medicinal-products-psusa-00010622-202301_en.pdf"},
    {"id":"60076","name":"Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine) suspension for injection: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-09-20T14:48:00Z","last_updated_date":"2023-09-20T14:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vaxneuvance-pneumococcal-polysaccharide-conjugate-vaccine-suspension-injection-important-information-regarding-potential-breakage-vaxneuvance-pre_en.pdf"},
    {"id":"60114","name":"Presentation - Union Product Database - Product grouping and third country product names Webinar for Industry users","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-22T13:48:00Z","last_updated_date":"2023-09-22T13:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-union-product-database-product-grouping-and-third-country-product-names-webinar-industry-users_en.pdf"},
    {"id":"60124","name":"Presentation -  A new VMP regulation: one year in operation (Eva Zamora Escribano)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T11:48:00Z","last_updated_date":"2023-09-25T11:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-vmp-regulation-one-year-operation-eva-zamora-escribano_en.pdf"},
    {"id":"60126","name":"Presentation - Fostering better veterinary medicines globally through international engagement and connections (Martin Harvey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T11:53:00Z","last_updated_date":"2023-09-25T11:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-fostering-better-veterinary-medicines-globally-through-international-engagement-and-connections-martin-harvey_en.pdf"},
    {"id":"60127","name":"Presentation - Veterinary novel therapies and technologies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T12:10:00Z","last_updated_date":"2023-09-25T12:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-novel-therapies-and-technologies_en.pdf"},
    {"id":"60129","name":"Presentation - Environmental safety of parasiticidal veterinary medicinal products (VMPs) for cats and dogs in the EU/EEAEMA (Haru Kroneis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T12:15:00Z","last_updated_date":"2023-09-25T12:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-environmental-safety-parasiticidal-veterinary-medicinal-products-vmps-cats-and-dogs-eu-eeaema-haru-kroneis_en.pdf"},
    {"id":"60130","name":"Presentation - Environmental impact assessment matters (Ivo Roessink)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T12:38:00Z","last_updated_date":"2023-09-25T12:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-environmental-impact-assessment-matters-ivo-roessink_en.pdf"},
    {"id":"60131","name":"Presentation - Impact of animals in society (Nancy De Briyne)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T13:20:00Z","last_updated_date":"2023-09-25T13:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-impact-animals-society-nancy-de-briyne_en.pdf"},
    {"id":"60132","name":"Public statement on Invirase : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T13:21:00Z","last_updated_date":"2023-09-25T13:21:00Z","reference_number":"EMA/375031/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-invirase-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"60140","name":"Presentation - Emergency Task Force (ETF) update - A. Simonds (ERS) and J. Drabwell (IPOPI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:06:00Z","last_updated_date":"2023-09-25T16:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emergency-task-force-etf-update-simonds-ers-and-j-drabwell-ipopi_en.pdf"},
    {"id":"60141","name":"Presentation - Medicines Shortages Steering Group (MSSG) - C. Roffiaen (EPHA) and P. Polidori (EAHP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:10:00Z","last_updated_date":"2023-09-25T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicines-shortages-steering-group-mssg-c-roffiaen-epha-and-p-polidori-eahp_en.pdf"},
    {"id":"60142","name":"Presentation - Role of EMA in facilitating Clinical Trials in emergencies - M. Mura (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:15:00Z","last_updated_date":"2023-09-25T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-ema-facilitating-clinical-trials-emergencies-m-mura-ema_en.pdf"},
    {"id":"60143","name":"Presentation - Big Data Steering Group update - D. Umuhire (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:17:00Z","last_updated_date":"2023-09-25T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-steering-group-update-d-umuhire-ema_en.pdf"},
    {"id":"60144","name":"Presentation - Feedback from surveys on medicine shortages - I. Abed (EMA) and S. Marschler (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:20:00Z","last_updated_date":"2023-09-25T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-surveys-medicine-shortages-i-abed-ema-and-s-marschler-ema_en.pdf"},
    {"id":"60145","name":"Presentation - EU list of Critical Medicines - J. Ferreira (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:22:00Z","last_updated_date":"2023-09-25T16:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-list-critical-medicines-j-ferreira-ema_en.pdf"},
    {"id":"60146","name":"Presentation - Update on preparedness activities - E. Matelyte (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:23:00Z","last_updated_date":"2023-09-25T16:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-preparedness-activities-e-matelyte-ema_en.pdf"},
    {"id":"60147","name":"Presentation - An analysis of regulated medicines information for cancer patients - C. Davis (Health Action International)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:26:00Z","last_updated_date":"2023-09-25T16:26:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-analysis-regulated-medicines-information-cancer-patients-c-davis-health-action-international_en.pdf"},
    {"id":"60148","name":"Presentation - QRD Template revision for package leaflet improvement - M. Buch (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:30:00Z","last_updated_date":"2023-09-25T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-qrd-template-revision-package-leaflet-improvement-m-buch-ema_en.pdf"},
    {"id":"60149","name":"Presentation - ICH E21: inclusion of pregnant & breastfeeding individuals in clinical trials - C. de Vries (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:32:00Z","last_updated_date":"2023-09-25T16:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-e21-inclusion-pregnant-breastfeeding-individuals-clinical-trials-c-de-vries-ema_en.pdf"},
    {"id":"60150","name":"Presentation - Proposal for ACT EU MSP Advisory Group - A. Zanoletty (EMA) and M. Filancia (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:33:00Z","last_updated_date":"2023-09-25T16:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposal-act-eu-msp-advisory-group-zanoletty-ema-and-m-filancia-ema_en.pdf"},
    {"id":"60151","name":"Presentation - EMA Social Media Strategy 2023-2025 - C. Enachioiu (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:36:00Z","last_updated_date":"2023-09-25T16:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-social-media-strategy-2023-2025-c-enachioiu-ema_en.pdf"},
    {"id":"60152","name":"Presentation - Addressing mis- and disinformation - S. Labbé (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T16:38:00Z","last_updated_date":"2023-09-25T16:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-addressing-mis-and-disinformation-s-labbe-ema_en.pdf"},
    {"id":"60153","name":"Vaccine Monitoring Platform (VMP) research agenda","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-09-26T09:55:00Z","last_updated_date":"2023-09-26T09:55:00Z","reference_number":"EMA/430310/2023","document_url":"https://www.ema.europa.eu/en/documents/other/vaccine-monitoring-platform-vmp-research-agenda_en.pdf-0"},
    {"id":"60154","name":"Questions and answers - Q3 2023 System Demo","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-09-26T12:18:00Z","last_updated_date":"2023-09-26T12:18:00Z","reference_number":"EMA/429086/2023","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-q3-2023-system-demo_en.pdf"},
    {"id":"60156","name":"Academia Info Day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-26T14:46:00Z","last_updated_date":"2023-09-26T14:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/academia-info-day_en.pdf"},
    {"id":"60157","name":"Presentation - Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR API Webinar presentation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-26T15:04:00Z","last_updated_date":"2023-09-26T15:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-product-organisation-and-referential-spor-application-programming-interface-api-spor-api-webinar-presentation_en.pdf"},
    {"id":"60161","name":"Presentation - Substance Management Service (SMS) Webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T10:08:00Z","last_updated_date":"2023-09-27T10:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-substance-management-service-sms-webinar_en.pdf"},
    {"id":"60163","name":"Presentation - Product Management Service (XEVMPD) Webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T10:15:00Z","last_updated_date":"2023-10-06T16:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-management-service-xevmpd-webinar_en.pdf"},
    {"id":"60164","name":"Presentation : SPOR Data Governance Webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T11:12:00Z","last_updated_date":"2023-09-27T11:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spor-data-governance-webinar_en.pdf"},
    {"id":"60165","name":"Presentation - Referentials Management Service (RMS) Webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T11:22:00Z","last_updated_date":"2023-09-27T11:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-referentials-management-service-rms-webinar_en.pdf"},
    {"id":"60166","name":"Presentation - Organisation Management Service (OMS) Webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T11:27:00Z","last_updated_date":"2023-09-27T11:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-organisation-management-service-oms-webinar_en.pdf"},
    {"id":"60169","name":"Joint Meeting of CTTI/FDA Patient Engagement Collaborative (PEC) and EMA Patients’ and Consumers’ Working Party (PCWP)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T14:23:00Z","last_updated_date":"2023-09-27T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/joint-meeting-ctti-fda-patient-engagement-collaborative-pec-and-ema-patients-and-consumers-working-party-pcwp_en.pdf"},
    {"id":"60170","name":"Decentralized Clinical Trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T14:27:00Z","last_updated_date":"2023-09-27T14:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/decentralized-clinical-trials_en.pdf"},
    {"id":"60171","name":"EU Recommendations on Decentralised Elements in Clinical Trials","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T14:28:00Z","last_updated_date":"2023-09-27T14:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/eu-recommendations-decentralised-elements-clinical-trials_en.pdf"},
    {"id":"60176","name":"Presentation - Recent developments in livestock welfare science (Hans Spoolder)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T17:27:00Z","last_updated_date":"2023-09-27T17:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recent-developments-livestock-welfare-science-hans-spoolder_en.pdf"},
    {"id":"60177","name":"Presentation - Collaboration with academia on regulatory science activities (Ralf Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T17:31:00Z","last_updated_date":"2023-09-27T17:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-collaboration-academia-regulatory-science-activities-ralf-herold_en.pdf"},
    {"id":"60180","name":"Presentation - CVMP role and responsibilities (Frida Wikstrom)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T17:37:00Z","last_updated_date":"2023-09-27T17:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cvmp-role-and-responsibilities-frida-wikstrom_en.pdf"},
    {"id":"60181","name":"Presentation - Perspective of the manufacturers of veterinary medicines (Frederik Schutte)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T17:39:00Z","last_updated_date":"2023-09-27T17:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-perspective-manufacturers-veterinary-medicines-frederik-schutte_en.pdf"},
    {"id":"60197","name":"Fenoterol / ipratropium : List of nationally authorised medicinal products - PSUSA/00001367/202302","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-28T16:08:00Z","last_updated_date":"2023-09-28T16:08:00Z","reference_number":"EMA/438193/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/fenoterol-ipratropium-list-nationally-authorised-medicinal-products-psusa-00001367-202302_en.pdf"},
    {"id":"60202","name":"Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202303","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-29T10:08:00Z","last_updated_date":"2023-09-29T10:08:00Z","reference_number":"EMA/348780/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa-00001744-202303_en.pdf"},
    {"id":"60203","name":"Haemophilus type b and meningococcal group C conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/202302","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-29T10:28:00Z","last_updated_date":"2023-09-29T10:28:00Z","reference_number":"EMA/396846/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/haemophilus-type-b-and-meningococcal-group-c-conjugate-vaccine-list-nationally-authorised-medicinal-products-psusa-00001583-202302_en.pdf"},
    {"id":"60204","name":"Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202303","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-29T10:35:00Z","last_updated_date":"2023-09-29T10:35:00Z","reference_number":"EMA/348784/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa-00010298-202303_en.pdf"},
    {"id":"60205","name":"Sodium citrate (extracorporeal use) : List of nationally authorised medicinal products - PSUSA/00010986/202301","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-29T10:38:00Z","last_updated_date":"2023-09-29T10:38:00Z","reference_number":"EMA/433904/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-citrate-extracorporeal-use-list-nationally-authorised-medicinal-products-psusa-00010986-202301_en.pdf"},
    {"id":"60206","name":"Ipratropium : List of nationally authorised medicinal products - PSUSA/00001780/202301","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-09-29T10:50:00Z","last_updated_date":"2023-09-29T10:50:00Z","reference_number":"EMA/437314/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/ipratropium-list-nationally-authorised-medicinal-products-psusa-00001780-202301_en.pdf"},
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    {"id":"44149","name":"Septanest Article-30 referral - Use of Septanest and associated names (articaine / adrenaline solutions for injection) to be harmonised in EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-03-29T12:00:00Z","last_updated_date":"2019-06-19T12:41:00Z","reference_number":"EMA/186900/2019 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/septanest-article-30-referral-use-septanest-and-associated-names-articaine-adrenaline-solutions-injection-be-harmonised-eu_sv.pdf"}},
    {"id":"44534","name":"Angiotensin-II-receptor antagonists (sartans) Article 31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-05-17T10:15:00Z","last_updated_date":"2019-05-17T10:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/angiotensin-ii-receptor-antagonists-sartans-article-31-referral-annex-i_sv.pdf"}},
    {"id":"45096","name":"Basiron AC Article-13 referral - Questions and answers on Basiron AC and associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-03-29T13:54:00Z","last_updated_date":"2019-07-19T14:09:00Z","reference_number":"EMA/400057/2019","document_url":"https://www.ema.europa.eu/en/documents/referral/basiron-ac-article-13-referral-questions-and-answers-basiron-ac-and-associated-names_en.pdf-0"},
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    {"id":"45098","name":"Basiron AC - Article 13 referral - Annex II","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2019-07-19T13:57:00Z","last_updated_date":"2019-07-19T13:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/basiron-ac-article-13-referral-annex-ii_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/basiron-ac-article-13-referral-annex-ii_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/basiron-ac-article-13-referral-annex-ii_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/basiron-ac-article-13-referral-annex-ii_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/basiron-ac-article-13-referral-annex-ii_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/basiron-ac-article-13-referral-annex-ii_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/basiron-ac-article-13-referral-annex-ii_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/basiron-ac-article-13-referral-annex-ii_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/basiron-ac-article-13-referral-annex-ii_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/basiron-ac-article-13-referral-annex-ii_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/basiron-ac-article-13-referral-annex-ii_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/basiron-ac-article-13-referral-annex-ii_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/basiron-ac-article-13-referral-annex-ii_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/basiron-ac-article-13-referral-annex-ii_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/basiron-ac-article-13-referral-annex-ii_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/basiron-ac-article-13-referral-annex-ii_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/basiron-ac-article-13-referral-annex-ii_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/basiron-ac-article-13-referral-annex-ii_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/basiron-ac-article-13-referral-annex-ii_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/basiron-ac-article-13-referral-annex-ii_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/basiron-ac-article-13-referral-annex-ii_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/basiron-ac-article-13-referral-annex-ii_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/basiron-ac-article-13-referral-annex-ii_sv.pdf","no":"https://www.ema.europa.eu/no/documents/referral/basiron-ac-article-13-referral-annex-ii_no.pdf"}},
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    {"id":"60573","name":"EU/3/17/1927: Public summary of opinion on orphan designation: Pracinostat for the treatment of acute myeloid leukaemia","type":"orphan-designation","status":"unknown","consultation_date":"","first_published_date":"2018-01-09T15:45:00Z","last_updated_date":"2022-02-18T15:45:00Z","reference_number":"EMA/623210/2017","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu-3-17-1927-public-summary-opinion-orphan-designation-pracinostat-treatment-acute-myeloid-leukaemia_en.pdf"},
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    {"id":"60582","name":"European Medicines Agency rapid response to the British Medical Journal on Pandemrix","type":"other","status":"unknown","consultation_date":"","first_published_date":"2018-09-26T16:38:00Z","last_updated_date":"2018-09-26T16:38:00Z","reference_number":"EMA/659264/2018","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-rapid-response-british-medical-journal-pandemrix_en.pdf"},
    {"id":"60583","name":"Withdrawal letter: Entolimod TMC","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2018-09-25T17:43:00Z","last_updated_date":"2018-09-25T17:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-entolimod-tmc_en.pdf"},
    {"id":"60585","name":"Agenda - CAT agenda for the written procedure of 15-17 August 2018","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2018-10-03T17:10:00Z","last_updated_date":"2018-10-03T17:10:00Z","reference_number":"EMA/CAT/553521/2018","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-written-procedure-15-17-august-2018_en.pdf"},
    {"id":"42291","name":"EU/3/18/2041: Public summary of opinion on orphan designation: 2ʹ-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA for the treatment of behavioural variant frontotemporal dementia","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2018-10-11T09:10:00Z","last_updated_date":"2018-10-11T09:10:00Z","reference_number":"EMA/470356/2018","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu-3-18-2041-public-summary-opinion-orphan-designation-2-o-2-methoxyethyl-antisense-oligonucleotide-targeting-microtubule-associated-protein-tau-pre-mrna-treatment-behavioural-variant-frontotemporal_en.pdf"},
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    {"id":"48652","name":"Scientific recommendation on classification of  advanced therapy medicinal products: Autologous CD34+ cells transduced with a lentiviral vector encoding for the CD18 β-subunit of human β2 Integrin","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/189223/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-autologous-cd34-cells-transduced-lentiviral-vector-encoding-cd18-b-subunit-human-b2-integrin_en.pdf"},
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    {"id":"48670","name":"Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed messenger RNA molecules encoding IFNα2b, IL-12, IL-15sushi and GM-CSF cytokines","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/235528/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-vitro-transcribed-messenger-rna-molecules-encoding-ifna2b-il-12-il-15sushi-and-gm-csf-cytokines_en.pdf"},
    {"id":"48674","name":"Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 containing a human α-L-iduronidase gene cassette","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2020-08-20T10:15:00Z","last_updated_date":"2020-08-20T10:15:00Z","reference_number":"EMA/234920/2019 ","document_url":"https://www.ema.europa.eu/en/documents/report/scientific-recommendation-classification-advanced-therapy-medicinal-products-recombinant-adeno-associated-virus-serotype-9-containing-human-l-iduronidase-gene-cassette_en.pdf"},
    {"id":"60617","name":"EU/3/20/2297: Public summary of opinion on orphan designation for Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the treatment of metachromatic leukodystrophy","type":"orphan-designation","status":"Adopted","consultation_date":"","first_published_date":"2020-09-24T14:53:00Z","last_updated_date":"2023-07-21T12:38:00Z","reference_number":"EMADOC-628903358-2485","document_url":"https://www.ema.europa.eu/en/documents/orphan-designation/eu-3-20-2297-public-summary-opinion-orphan-designation-adeno-associated-virus-serotype-hsc15-expressing-human-arylsulfatase-gene-treatment-metachromatic-leukodystrophy_en.pdf"},
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    {"id":"55963","name":"Topiramate Article-31 referral - Annex I","type":"referral","status":"Draft","consultation_date":"","first_published_date":"2022-09-02T14:20:00Z","last_updated_date":"2023-11-10T17:29:00Z","reference_number":"EMA/722981/2022 rev.1","document_url":"https://www.ema.europa.eu/en/documents/referral/topiramate-article-31-referral-annex-i_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/topiramate-article-31-referral-annex-i_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/topiramate-article-31-referral-annex-i_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/topiramate-article-31-referral-annex-i_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/topiramate-article-31-referral-annex-i_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/topiramate-article-31-referral-annex-i_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/topiramate-article-31-referral-annex-i_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/topiramate-article-31-referral-annex-i_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/topiramate-article-31-referral-annex-i_fr.pdf","ga":"https://www.ema.europa.eu/ga/documents/referral/topiramate-article-31-referral-annex-i_ga.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/topiramate-article-31-referral-annex-i_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/topiramate-article-31-referral-annex-i_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/topiramate-article-31-referral-annex-i_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/topiramate-article-31-referral-annex-i_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/topiramate-article-31-referral-annex-i_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/topiramate-article-31-referral-annex-i_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/topiramate-article-31-referral-annex-i_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/topiramate-article-31-referral-annex-i_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/topiramate-article-31-referral-annex-i_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/topiramate-article-31-referral-annex-i_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/topiramate-article-31-referral-annex-i_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/topiramate-article-31-referral-annex-i_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/topiramate-article-31-referral-annex-i_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/topiramate-article-31-referral-annex-i_sv.pdf","is":"https://www.ema.europa.eu/is/documents/referral/topiramate-article-31-referral-annex-i_is.pdf","no":"https://www.ema.europa.eu/no/documents/referral/topiramate-article-31-referral-annex-i_no.pdf"}},
    {"id":"57454","name":"Presentation - Myocarditis after mRNA COVID-19 vaccines in the United States: children aged ≤11 years, and follow-up among people aged 12-29 years at least 90 days after symptom onset of myocarditis (John R. Su)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-01-31T17:38:00Z","last_updated_date":"2023-01-31T17:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-myocarditis-after-mrna-covid-19-vaccines-united-states-children-aged-11-years-and-follow-among-people-aged-12-29-years-least-90-days-after-symptom-onset-myocarditis-john-r-su_en.pdf"},
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    {"id":"57963","name":"EMA reply to a letter from Members of the European Parliament, Mr Agius Saliba, Ms Ries, Mr Duda, Mr Biedroń, Ms Cerdas and Ms Metz concerning psychedelic-assisted therapies","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-03-09T13:42:00Z","last_updated_date":"2023-03-09T13:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-reply-letter-members-european-parliament-mr-agius-saliba-ms-ries-mr-duda-mr-biedron-ms-cerdas-and-ms-metz-concerning-psychedelic-assisted-therapies_en.pdf"},
    {"id":"58099","name":"2022 European Medicines Agency annual report on independence","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T15:35:00Z","last_updated_date":"2023-11-06T21:15:00Z","reference_number":"EMA/2588/2023","document_url":"https://www.ema.europa.eu/en/documents/report/2022-european-medicines-agency-annual-report-independence_en.pdf"},
    {"id":"60697","name":"Janus Kinase inhibitors (JAKi) Article-20 procedure - Divergent positions to CHMP Opinion","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-03-22T13:29:00Z","last_updated_date":"2023-06-14T16:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/janus-kinase-inhibitors-jaki-article-20-procedure-divergent-positions-chmp-opinion_en.pdf"},
    {"id":"60704","name":"CTIS Bitesize Talk: IMPD-Q-only submission","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-07T11:17:00Z","last_updated_date":"2023-06-07T11:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/ctis-bitesize-talk-impd-q-only-submission_en.pdf"},
    {"id":"60705","name":"CTIS Bitesize Talk - IMPD-Q-only Submission - presentation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-07T11:48:00Z","last_updated_date":"2023-06-07T11:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/ctis-bitesize-talk-impd-q-only-submission-presentation_en.pdf"},
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    {"id":"60707","name":"CTIS Bitesize Talk - IMPD-Q-only Submission - presentation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-06-07T12:02:00Z","last_updated_date":"2023-06-07T12:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/ctis-bitesize-talk-impd-q-only-submission-presentation_en.pdf-1"},
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    {"id":"60728","name":"ICH M7(R2) Questions and Answers on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-07-19T16:56:00Z","last_updated_date":"2023-07-19T16:56:00Z","reference_number":"EMA/CHMP/ICH/321999/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m7r2-questions-and-answers-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-step-5_en.pdf"},
    {"id":"60729","name":"CHMP summary of positive opinion for Degarelix Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-07-21T12:00:00Z","last_updated_date":"2023-07-21T12:00:00Z","reference_number":"EMA/CHMP/325725/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-degarelix-accord_en.pdf"},
    {"id":"59564","name":"Programme of the 2023 annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-08-07T14:53:00Z","last_updated_date":"2023-10-05T12:03:00Z","reference_number":"EMA/345059/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-2023-annual-workshop-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"59569","name":"Morphine / cyclizine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"60735","name":"Agenda ACT EU Multi-stakeholder workshop on methodology guidance","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-08-10T16:59:00Z","last_updated_date":"2023-11-07T14:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-act-eu-multi-stakeholder-workshop-methodology-guidance_en.pdf"},
    {"id":"59608","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Lutholaz (pegfilgrastim)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2023-08-18T12:44:00Z","last_updated_date":"2023-11-07T15:08:00Z","reference_number":"EMA/352990/2023","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-and-answers-withdrawal-application-marketing-authorisation-lutholaz-pegfilgrastim_sv.pdf"}},
    {"id":"60739","name":"Highlights from the 10th meeting of the Nitrosamine Implementation Oversight Group (NIOG)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-09-05T11:52:00Z","last_updated_date":"2023-09-05T11:52:00Z","reference_number":"EMA/INS/GMP/190573/2023","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-10th-meeting-nitrosamine-implementation-oversight-group-niog_en.pdf"},
    {"id":"60740","name":"Agenda – Nitrosamine Implementation Oversight Group (NIOG) – fifth meeting with  pharmaceutical industry","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-05T11:59:00Z","last_updated_date":"2023-09-05T11:59:00Z","reference_number":"EMA/INS/GMP/208026/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-nitrosamine-implementation-oversight-group-niog-fifth-meeting-pharmaceutical-industry_en.pdf"},
    {"id":"60741","name":"Presentation - Nitrosamine Implementation Oversight Group (NIOG) – fifth meeting with  pharmaceutical industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-05T12:01:00Z","last_updated_date":"2023-09-05T12:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-nitrosamine-implementation-oversight-group-niog-fifth-meeting-pharmaceutical-industry_en.pdf"},
    {"id":"60742","name":"Highlights from the 11th meeting of the Nitrosamine Implementation Oversight Group (NIOG)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-09-05T11:56:00Z","last_updated_date":"2023-09-05T11:56:00Z","reference_number":"EMA/353244/2023","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-11th-meeting-nitrosamine-implementation-oversight-group-niog_en.pdf"},
    {"id":"60743","name":"Presentation - Antimicrobial resistance (AMR) initiatives (Zoltan Kunsagi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T11:55:00Z","last_updated_date":"2023-09-25T11:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antimicrobial-resistance-amr-initiatives-zoltan-kunsagi_en.pdf"},
    {"id":"60744","name":"Presentation - Alternatives to veterinary antimicrobials (AVANT) (Luca Guardabassi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T11:57:00Z","last_updated_date":"2023-09-25T11:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-alternatives-veterinary-antimicrobials-avant-luca-guardabassi_en.pdf"},
    {"id":"60745","name":"Presentation - Availability of VMPs promoting the authorisation of alternatives to antimicrobials (Noemi Garcia del Blanco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T12:12:00Z","last_updated_date":"2023-09-25T12:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-availability-vmps-promoting-authorisation-alternatives-antimicrobials-noemi-garcia-del-blanco_en.pdf"},
    {"id":"60746","name":"Presentation - The societal impacts of animals (Carel du Marchie Sarvaas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T12:35:00Z","last_updated_date":"2023-09-25T12:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-societal-impacts-animals-carel-du-marchie-sarvaas_en.pdf"},
    {"id":"60748","name":"Presentation - Advancing acceptance of 3Rs testing approaches for regulatory testing of medicinal products in the EUThe EMA 3Rs Working Party (Sonja Beken)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T13:34:00Z","last_updated_date":"2023-09-25T13:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-advancing-acceptance-3rs-testing-approaches-regulatory-testing-medicinal-products-euthe-ema-3rs-working-party-sonja-beken_en.pdf"},
    {"id":"60749","name":"Presentation - 3RsWP working topics related to veterinary medicinal products (Sarah Adler-Flindt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T13:38:00Z","last_updated_date":"2023-09-25T13:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-3rswp-working-topics-related-veterinary-medicinal-products-sarah-adler-flindt_en.pdf"},
    {"id":"60750","name":"Informative Webinar on Regulatory Procedure Management  for Product Lifecycle Management 1st roll-out on IRIS","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-09-26T11:21:00Z","last_updated_date":"2023-09-26T11:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/informative-webinar-regulatory-procedure-management-product-lifecycle-management-1st-roll-out-iris_en.pdf"},
    {"id":"60158","name":"Agenda - EMA Academia Info Day Agenda","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-09-26T17:11:00Z","last_updated_date":"2023-11-10T09:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-academia-info-day-agenda_en.pdf"},
    {"id":"60754","name":"Presentation - EU list of critical medicines (J.Ferreira)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-10-03T11:52:00Z","last_updated_date":"2023-10-03T11:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-list-critical-medicines-jferreira_en.pdf"},
    {"id":"60755","name":"Presentation - Regulatory Research Science Needs (P.Moscariello)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-10-03T12:01:00Z","last_updated_date":"2023-10-03T12:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-research-science-needs-pmoscariello_en.pdf"},
    {"id":"60757","name":"Presentation - CTIS bitesize talk - Transition trials - 21 Jun 2023","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-10-03T12:28:00Z","last_updated_date":"2023-10-03T12:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-bitesize-talk-transition-trials-21-jun-2023_en.pdf"},
    {"id":"60759","name":"Draft agenda - Focus group meeting for veterinarians or  other healthcare professionals on facilitating  pharmacovigilance reporting of medicinal products used  in poultry","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-10-04T15:35:00Z","last_updated_date":"2023-10-04T15:35:00Z","reference_number":"EMA/619465/2022 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-focus-group-meeting-veterinarians-or-other-healthcare-professionals-facilitating-pharmacovigilance-reporting-medicinal-products-used-poultry_en.pdf"},
    {"id":"60287","name":"CVMP summary of positive opinion for Senvelgo","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2023-10-06T14:20:00Z","last_updated_date":"2023-10-06T14:20:00Z","reference_number":"EMA/CVMP/432172/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-senvelgo_en.pdf"},
    {"id":"60761","name":"Agenda of the CHMP meeting 09-12 October 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-10-09T14:36:00Z","last_updated_date":"2023-10-09T14:36:00Z","reference_number":"EMA/CHMP/421839/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-09-12-october-2023_en.pdf"},
    {"id":"60763","name":"Aldesleukin : List of nationally authorised medicinal products - PSUSA/00000076/202212","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-10-10T12:11:00Z","last_updated_date":"2023-10-10T12:11:00Z","reference_number":"EMA/PRAC/453290/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/aldesleukin-list-nationally-authorised-medicinal-products-psusa-00000076-202212_en.pdf"},
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    {"id":"60765","name":"CHMP summary of positive opinion for Prevymis","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T12:00:00Z","last_updated_date":"2023-10-13T12:00:00Z","reference_number":"EMA/454102/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-summary-positive-opinion-prevymis_en.pdf"},
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    {"id":"60767","name":"European Medicines Agency mid-year report 2023 (January-June 2023)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-10-18T13:56:00Z","last_updated_date":"2023-10-18T13:56:00Z","reference_number":"EMA/343593/2023","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-mid-year-report-2023-january-june-2023_en.pdf"},
    {"id":"60459","name":"Paroxetine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"60464","name":"Agenda : Joint Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) AI workshop – Smart regulation in a rapidly evolving world","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-10-23T11:36:00Z","last_updated_date":"2023-11-10T10:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-heads-medicines-agencies-hma-european-medicines-agency-ema-ai-workshop-smart-regulation-rapidly-evolving-world_en.pdf"},
    {"id":"60770","name":"Agenda – EMA - Thalassaemia International Federation (TIF) bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-10-23T14:23:00Z","last_updated_date":"2023-10-23T14:23:00Z","reference_number":"EMA/382643/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-thalassaemia-international-federation-tif-bilateral-meeting_en.pdf"},
    {"id":"60771","name":"Highlights of EMA - Thalassaemia International Federation (TIF) bilateral meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-10-23T14:31:00Z","last_updated_date":"2023-10-23T14:31:00Z","reference_number":"EMA/473390/2023","document_url":"https://www.ema.europa.eu/en/documents/minutes/highlights-ema-thalassaemia-international-federation-tif-bilateral-meeting_en.pdf"},
    {"id":"60773","name":"Assessment outcome of occupational activities after leaving the service F Sweeney 19.10.23","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-10-26T09:04:00Z","last_updated_date":"2023-10-26T09:04:00Z","reference_number":"EMA/480774/2023","document_url":"https://www.ema.europa.eu/en/documents/other/assessment-outcome-occupational-activities-after-leaving-service-f-sweeney-191023_en.pdf"},
    {"id":"60774","name":"Question and answers - Union Product Database - Product grouping and third country product names Webinar for Industry users","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-10-27T10:35:00Z","last_updated_date":"2023-11-03T15:00:00Z","reference_number":"EMA/483124/2023","document_url":"https://www.ema.europa.eu/en/documents/other/question-and-answers-union-product-database-product-grouping-and-third-country-product-names-webinar-industry-users_en.pdf"},
    {"id":"60776","name":"CTIS newsflash – 27 October 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-10-30T09:23:00Z","last_updated_date":"2023-10-30T09:23:00Z","reference_number":"EMA/471461/2023","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-27-october-2023_en.pdf"},
    {"id":"60777","name":"Agenda of the CHMP meeting 6-9 November 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-11-06T12:11:00Z","last_updated_date":"2023-11-06T12:11:00Z","reference_number":"EMA/CHMP/460963/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-6-9-november-2023_en.pdf"},
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    {"id":"60785","name":"Agenda of the CVMP meeting 7-9 November 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-11-07T12:42:00Z","last_updated_date":"2023-11-07T12:42:00Z","reference_number":"EMA/494916/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-7-9-november-2023_en.pdf"},
    {"id":"60787","name":"Public statement on Rebetol : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-11-07T14:44:00Z","last_updated_date":"2023-11-07T14:44:00Z","reference_number":"EMA/431866/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-rebetol-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"60788","name":"Withdrawal assessment report for Lutholaz","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2023-11-07T15:00:00Z","last_updated_date":"2023-11-07T15:00:00Z","reference_number":"EMA/CHMP/343552/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-lutholaz_en.pdf"},
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    {"id":"60794","name":"Presentation - EHA multiple myeloma CMF June 2023","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-07T17:25:00Z","last_updated_date":"2023-11-07T17:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eha-multiple-myeloma-cmf-june-2023_en.pdf"},
    {"id":"60795","name":"Presentation - EMA proposals to optimise treatment within current procedures CMF june 2023","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-07T17:27:00Z","last_updated_date":"2023-11-07T17:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-proposals-optimise-treatment-within-current-procedures-cmf-june-2023_en.pdf"},
    {"id":"60796","name":"Withdrawal assessment report for RoActemra","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2023-11-07T17:44:00Z","last_updated_date":"2023-11-07T17:44:00Z","reference_number":"EMA/495669/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-roactemra_en.pdf"},
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    {"id":"60846","name":"Azithromycin Article-31 referral - Notification","type":"position","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T11:52:00Z","last_updated_date":"2023-11-10T11:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/position/azithromycin-article-31-referral-notification_en.pdf"},
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    {"id":"60908","name":"Questions and answers on the outcome of assessment on use of Moventig (naloxegol) in treatment of constipation due to opioids","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2023-11-13T16:19:00Z","last_updated_date":"2023-11-13T16:19:00Z","reference_number":"EMA/488713/2023","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-outcome-assessment-use-moventig-naloxegol-treatment-constipation-due-opioids_en.pdf"},
    {"id":"60930","name":"Topiramate and topiramate/phentermine combination: New restrictions to prevent exposure during pregnancy","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-11-21T13:12:55Z","last_updated_date":"2023-11-21T13:12:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/topiramate-and-topiramate-phentermine-combination-new-restrictions-prevent-exposure-during-pregnancy_en.pdf"},
    {"id":"58949","name":"Registration form and agenda - EMA EudraVigilance and Signal Management Information Day","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-06-15T10:20:00Z","last_updated_date":"2023-11-21T17:03:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/registration-form-and-agenda-ema-eudravigilance-and-signal-management-information-day_en.pdf"},
    {"id":"2401","name":"Draft guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2007-03-01 - 2007-11-01","first_published_date":"2007-03-22T02:00:00Z","last_updated_date":"2007-03-22T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/125459/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-studies-required-first-clinical-use-gene-therapy-medicinal-products_en.pdf"},
    {"id":"2508","name":"Draft guideline on core summary of product characteristics for human albumin solution","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-07-01 - 2012-08-31","first_published_date":"2012-06-29T13:30:00Z","last_updated_date":"2012-06-29T13:30:00Z","reference_number":"EMA/CHMP/BPWP/494462/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-human-albumin-solution_en.pdf"},
    {"id":"2552","name":"Draft guideline on core SmPC and Package Leaflet for gadopentetate dimeglumine","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-01 - 2016-04-30","first_published_date":"2016-02-01T17:46:00Z","last_updated_date":"2016-02-01T17:46:00Z","reference_number":"EMA/CHMP/39163/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-gadopentetate-dimeglumine_en.pdf"},
    {"id":"2623","name":"Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-28 - 2017-11-15","first_published_date":"2017-07-28T16:30:00Z","last_updated_date":"2017-07-28T16:30:00Z","reference_number":"EMA/CHMP/800914/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-predictive-biomarker-based-assay-development-context-drug-development-and-lifecycle_en.pdf"},
    {"id":"2638","name":"Call for scientific data for use in HMPC assessment work on Adhatoda vasica Nees, folium - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558963/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-adhatoda-vasica-nees-folium-first-version_en.pdf"},
    {"id":"2641","name":"EMEA post-authorisation guidance on parallel distribution","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2006-07-01 - 2006-08-10","first_published_date":"2006-07-19T04:00:00Z","last_updated_date":"2006-07-19T04:00:00Z","reference_number":"EMEA/Ho/2368/Rev 4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/emea-post-authorisation-guidance-parallel-distribution_en.pdf"},
    {"id":"2827","name":"Draft good practice guide on recording, coding, reporting and assessment of medication errors","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-14 - 2015-06-14","first_published_date":"2015-04-14T18:00:00Z","last_updated_date":"2015-04-14T18:00:00Z","reference_number":"EMA/762563/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-good-practice-guide-recording-coding-reporting-and-assessment-medication-errors_en.pdf"},
    {"id":"2870","name":"Draft European Union herbal monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos – Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-12-15 - 2018-03-15","first_published_date":"2017-12-08T19:35:00Z","last_updated_date":"2017-12-08T19:35:00Z","reference_number":"EMA/HMPC/327107/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"2945","name":"Draft guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-11-18 - 2011-05-31","first_published_date":"2010-11-26T02:00:00Z","last_updated_date":"2010-11-26T02:00:00Z","reference_number":"EMA/CHMP/BMWP/86289/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use_en.pdf"},
    {"id":"2998","name":"Draft list of references supporting the assessment of Commiphora molmol Engler, gummi-resina","type":"herbal-references","status":"Draft","consultation_date":"2010-09-01 - 2010-03-15","first_published_date":"2010-11-16T02:00:00Z","last_updated_date":"2010-11-16T02:00:00Z","reference_number":"EMA/HMPC/16634/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"3053","name":"Draft list of references supporting the assessment of Fumaria officinalis L., herba","type":"herbal-references","status":"Draft","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-04-04T04:00:00Z","last_updated_date":"2011-04-04T04:00:00Z","reference_number":"EMA/HMPC/576233/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-fumaria-officinalis-l-herba_en.pdf"},
    {"id":"3117","name":"Concept paper on the revision of the guideline on the development of medicinal products for the treatment of ulcerative colitis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-14 - 2013-02-15","first_published_date":"2012-10-31T19:00:00Z","last_updated_date":"2012-11-14T11:59:00Z","reference_number":"EMA/CHMP/204354/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-development-medicinal-products-treatment-ulcerative-colitis_en.pdf"},
    {"id":"3195","name":"Call for scientific data for the review of the HMPC assessment on Centella asiatica L. Urban, herba - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/248637/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-review-hmpc-assessment-centella-asiatica-l-urban-herba-first-version_en.pdf"},
    {"id":"3208","name":"Draft European Union herbal monograph on Helichrysum arenarium (L.) Moench, flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:35:00Z","last_updated_date":"2015-10-14T14:35:00Z","reference_number":"EMA/HMPC/41108/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-helichrysum-arenarium-l-moench-flos_en.pdf"},
    {"id":"3243","name":"Draft qualification opinion total kidney volume (TKV) as a prognostic biomarker for use in clinical trials evaluating patients with autosomal dominant polycystic kidney disease (ADPKD)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-02","first_published_date":"2015-07-22T13:00:00Z","last_updated_date":"2015-07-22T13:00:00Z","reference_number":"EMA/CHMP/SAWP/473433/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-total-kidney-volume-tkv-prognostic-biomarker-use-clinical-trials-evaluating-patients-autosomal-dominant-polycystic-kidney-disease-adpkd_en.pdf"},
    {"id":"3288","name":"Call for scientific data for the systematic review of the monograph on Sambucus nigra L., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-04-15 - 2016-07-15","first_published_date":"2016-04-15T20:00:00Z","last_updated_date":"2016-04-15T20:00:00Z","reference_number":"EMA/269955/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-sambucus-nigra-l-flos_en.pdf"},
    {"id":"3407","name":"Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-08 - 2012-08-31","first_published_date":"2012-06-08T14:20:00Z","last_updated_date":"2012-06-08T14:20:00Z","reference_number":"EMA/CHMP/172616/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-chmp-points-consider-evaluation-medicinal-products-treatment-irritable-bowel-syndrome_en.pdf"},
    {"id":"3419","name":"Concept paper on revising annex 16 of the guide to good manufacturing practice: Certification by a qualified person and batch release","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-10-01 - 2012-01-31","first_published_date":"2011-11-08T13:30:00Z","last_updated_date":"2011-11-08T13:30:00Z","reference_number":"EMA/INS/GMP/844118/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revising-annex-16-guide-good-manufacturing-practice-certification-qualified-person-and-batch-release_en.pdf"},
    {"id":"3421","name":"Draft guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1)","type":"template-form","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-02-29","first_published_date":"2015-12-15T13:30:00Z","last_updated_date":"2015-12-15T13:30:00Z","reference_number":"EMA/36988/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/template-form/draft-guideline-good-pharmacovigilance-practices-gvp-annex-ii-templates-direct-healthcare-professional-communication-dhpc-rev-1_en.pdf"},
    {"id":"3445","name":"Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-30 - 2019-08-01","first_published_date":"2018-07-09T17:22:00Z","last_updated_date":"2018-07-30T17:22:00Z","reference_number":"EMA/CHMP/171100/2018 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-develop-reflection-paper-development-medicinal-products-prevent-and-treat-acute-kidney-injury_en.pdf"},
    {"id":"3450","name":"Draft VICH GL50: Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-26 - 2016-08-01","first_published_date":"2016-02-26T16:30:00Z","last_updated_date":"2016-02-26T16:30:00Z","reference_number":"EMA/CVMP/VICH/582610/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl50-harmonisation-criteria-waive-target-animal-batch-safety-testing-inactivated-vaccines-veterinary-use_en.pdf"},
    {"id":"3462","name":"Call for scientific data for the systematic review of the monograph on Tanacetum parthenium (L.) Schulz Bip., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-06-15 - 2016-09-15","first_published_date":"2016-06-15T13:00:00Z","last_updated_date":"2016-06-15T13:00:00Z","reference_number":"EMA/HMPC/403695/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-tanacetum-parthenium-l-schulz-bip-herba_en.pdf"},
    {"id":"3477","name":"Reflection paper on anthelmintic resistance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-04-23 - 2014-07-31","first_published_date":"2014-04-23T13:10:00Z","last_updated_date":"2014-04-23T13:10:00Z","reference_number":"EMA/CVMP/EWP/573536/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-anthelmintic-resistance_en.pdf"},
    {"id":"3499","name":"Concept Paper on the Need for Revision of the Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-02-18 - 2010-04-30","first_published_date":"2010-03-03T02:00:00Z","last_updated_date":"2010-03-03T02:00:00Z","reference_number":"EMA/63033/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-stability-testing-applications-variations-marketing-authorisation_en.pdf"},
    {"id":"3534","name":"Draft elvitegravir 85 mg & 150 mg film-coated tablets product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-22 - 2017-03-31","first_published_date":"2016-12-22T14:00:00Z","last_updated_date":"2016-12-22T14:00:00Z","reference_number":"EMA/CHMP/805507/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-elvitegravir-85-mg-150-mg-film-coated-tablets-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"3538","name":"Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of ulcerative colitis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-01 - 2014-12-31","first_published_date":"2014-10-01T18:00:00Z","last_updated_date":"2014-10-01T18:00:00Z","reference_number":"EMA/CHMP/327812/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-guideline-development-new-medicinal-products-treatment-ulcerative-colitis_en.pdf"},
    {"id":"3550","name":"Call for scientific data for the systematic review of the monograph on Althaea officinalis L., radix.","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-12-12 - 2015-03-15","first_published_date":"2014-12-15T13:40:00Z","last_updated_date":"2014-12-15T13:40:00Z","reference_number":"EMA/HMPC/776605/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-althaea-officinalis-l-radix_en.pdf"},
    {"id":"3558","name":"Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00) - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-03-07 - 2012-05-31","first_published_date":"2012-03-07T18:30:00Z","last_updated_date":"2012-03-07T18:30:00Z","reference_number":"EMA/CHMP/SWP/888239/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-cpmp-463-00-first-version_en.pdf"},
    {"id":"3591","name":"Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-05-31 - 2012-11-30","first_published_date":"2012-05-31T21:08:31Z","last_updated_date":"2012-05-31T21:08:31Z","reference_number":"EMA/CHMP/BWP/247713/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-quality-issues-revision-1_en.pdf"},
    {"id":"3671","name":"Concept paper on Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-10-13 - 2012-01-31","first_published_date":"2011-10-25T19:00:00Z","last_updated_date":"2011-10-25T19:00:00Z","reference_number":"EMA/CVMP/SAGAM/435644/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-use-pleuromutilins-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"3782","name":"Call for scientific data for the systematic review of the monograph on Thymus vulgaris L., Thymus zygis Loefl. ex. L., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-04-15 - 2016-07-15","first_published_date":"2016-04-15T20:00:00Z","last_updated_date":"2016-04-15T20:00:00Z","reference_number":"EMA/269949/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-thymus-vulgaris-l-thymus-zygis-loefl-ex-l-aetheroleum_en.pdf"},
    {"id":"3800","name":"Draft guideline on the use of bovine serum in the manufacture of human biological medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-10-01 - 2012-12-31","first_published_date":"2012-10-01T15:25:00Z","last_updated_date":"2012-10-01T15:25:00Z","reference_number":"EMA/CHMP/BWP/457920/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-bovine-serum-manufacture-human-biological-medicinal-products_en.pdf"},
    {"id":"3826","name":"Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-01-01 - 2017-03-31","first_published_date":"2016-12-22T12:31:00Z","last_updated_date":"2016-12-22T12:31:00Z","reference_number":"EMA/CHMP/BPWP/94033/2007 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-revision-3_en.pdf"},
    {"id":"3904","name":"Concept paper on the need for revision of the CHMP note for guidance on the clinical development of medicinal products in the treatment of Asthma (CPMP/EWP/2922/01)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-22 - 2010-01-31","first_published_date":"2009-10-29T14:00:00Z","last_updated_date":"2009-10-29T14:00:00Z","reference_number":"EMEA/CHMP/EWP/10797/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-chmp-note-guidance-clinical-development-medicinal-products-treatment-asthma-cpmp-ewp-2922-01_en.pdf"},
    {"id":"3931","name":"Draft public statement on Picrorhiza kurroa Royle ex Benth, radix","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2014-07-31 - 2014-10-31","first_published_date":"2014-07-31T16:05:00Z","last_updated_date":"2014-07-31T16:05:00Z","reference_number":"EMA/HMPC/161476/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-picrorhiza-kurroa-royle-ex-benth-radix_en.pdf"},
    {"id":"3944","name":"Draft asenapine sublingual tablets 5 and 10 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-15 - 2015-11-01","first_published_date":"2015-07-15T14:00:00Z","last_updated_date":"2015-07-15T14:00:00Z","reference_number":"EMA/CHMP/PKWP/269533/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-asenapine-sublingual-tablets-5-and-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"3958","name":"Draft reflection paper on ethical and good-clinical-practice aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the Europe...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2010-03-23 - 2010-09-30","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/712397/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-reflection-paper-ethical-and-good-clinical-practice-aspects-clinical-trials-medicinal-products-human-use-conducted-third-countries-and-submitted-marketing-authorisation-applications-europe_en.pdf"},
    {"id":"3981","name":"Draft reflection paper on considerations given to designation of a single stereo isomeric form (enantiomer) as new active substance in relation to a reference active substance which is a racemic mixture of enantiomers","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-11-18 - 2011-02-28","first_published_date":"2010-11-23T02:00:00Z","last_updated_date":"2010-11-23T02:00:00Z","reference_number":"EMA/651649/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-considerations-given-designation-single-stereo-isomeric-form-enantiomer-new-active-substance-relation-reference-active-substance-which-racemic-mixture-enantiomers_en.pdf"},
    {"id":"3990","name":"Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-06-01 - 2017-08-31","first_published_date":"2017-06-01T13:30:00Z","last_updated_date":"2017-06-01T13:30:00Z","reference_number":"EMA/CHMP/197320/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-development-reflection-paper-regulatory-requirements-development-medicinal-products-chronic-non-infectious-liver-diseases-pbc-psc-nash_en.pdf"},
    {"id":"4042","name":"Concept paper on the revision of the 'Guideline on the assessment of clinical safety and efficacy in the preparation of Community herbal monographs for well- established and of Community herbal  monographs/entries to the...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-16 - 2016-01-31","first_published_date":"2015-10-16T14:00:00Z","last_updated_date":"2015-10-16T14:00:00Z","reference_number":"EMA/HMPC/427510/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-assessment-clinical-safety-and-efficacy-preparation-community-herbal-monographs-well-established-and-community-herbal-monographs-entries_en.pdf"},
    {"id":"4054","name":"Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products for the treatment and prevention of bipolar disorder","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-28 - 2016-10-31","first_published_date":"2016-07-28T21:10:00Z","last_updated_date":"2016-07-28T21:10:00Z","reference_number":"EMA/CHMP/318360/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-and-prevention-bipolar-disorder_en.pdf"},
    {"id":"4143","name":"Draft questions and answers on sodium laurilsulfate in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-08-04 - 2015-11-03","first_published_date":"2015-08-04T12:30:00Z","last_updated_date":"2015-08-04T12:30:00Z","reference_number":"EMA/CHMP/606830/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-sodium-laurilsulfate-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"4154","name":"Draft voriconazole product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/422408/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-voriconazole-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"4155","name":"Call for scientific data for the systematic review of the monograph on Verbascum thapsus L., V. densiflorum Bertol., V. phlomoides L., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-06-15 - 2016-09-15","first_published_date":"2016-06-15T13:00:00Z","last_updated_date":"2016-06-15T13:00:00Z","reference_number":"EMA/HMPC/403696/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-verbascum-thapsus-l-v-densiflorum-bertol-v-phlomoides-l-flos_en.pdf"},
    {"id":"4188","name":"Draft reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-19 - 2014-06-15","first_published_date":"2014-02-19T13:35:00Z","last_updated_date":"2014-02-19T13:35:00Z","reference_number":"EMA/HMPC/95714/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-microbiological-aspects-herbal-medicinal-products-and-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"4240","name":"Draft EudraVigilance access policy for medicines for veterinary use - Revision 1","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-06-27","first_published_date":"2018-04-30T15:33:00Z","last_updated_date":"2018-04-30T15:33:00Z","reference_number":"EMA/113700/2008 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-eudravigilance-access-policy-medicines-veterinary-use-revision-1_en.pdf"},
    {"id":"4247","name":"Draft emtricitabine/rilpivirine/tenofovir disoproxil, film-coated tablets, 200 mg/25 mg/245 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-22 - 2017-03-31","first_published_date":"2016-12-22T14:00:00Z","last_updated_date":"2016-12-22T14:00:00Z","reference_number":"EMA/CHMP/805532/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-emtricitabine-rilpivirine-tenofovir-disoproxil-film-coated-tablets-200-mg-25-mg-245-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"4287","name":"Draft public statement on Uncaria tomentosa (Willd. ex Schult.) DC., cortex","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2015-04-15 - 2015-07-15","first_published_date":"2015-04-15T13:00:00Z","last_updated_date":"2015-04-15T13:00:00Z","reference_number":"EMA/HMPC/588732/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-uncaria-tomentosa-willd-ex-schult-dc-cortex_en.pdf"},
    {"id":"4289","name":"Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 300","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-26 - 2017-08-31","first_published_date":"2017-04-26T19:30:00Z","last_updated_date":"2017-04-26T19:30:00Z","reference_number":"EMA/CHMP/813269/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-guideline-core-summary-product-characteristics-smpc-and-package-leaflet-iopamidol-300_en.pdf"},
    {"id":"4323","name":"Concept paper on the revision of the note for guidance on quality of modified release oral dosage forms and transdermal dosage forms: Section I (quality) - Superseded","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-10-31","first_published_date":"2010-07-30T04:00:00Z","last_updated_date":"2010-07-30T04:00:00Z","reference_number":"EMA/CHMP/QWP/202350/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-quality-modified-release-oral-dosage-forms-and-transdermal-dosage-forms-section-i-quality-superseded_en.pdf"},
    {"id":"4348","name":"Draft rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-28 - 2017-10-31","first_published_date":"2017-07-28T14:30:00Z","last_updated_date":"2017-07-28T14:30:00Z","reference_number":"EMA/CHMP/356878/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-rilpivirine-film-coated-tablets-25-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"4356","name":"Call for scientific data for use in HMPC assessment work on Phaseolus vulgaris L., fructus (sine semine)","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-17T19:43:00Z","last_updated_date":"2011-10-17T19:43:00Z","reference_number":"EMA/HMPC/558951/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-phaseolus-vulgaris-l-fructus-sine-semine_en.pdf"},
    {"id":"4363","name":"Draft European Union herbal monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeheyri Decne., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2016-02-15 - 2016-05-15","first_published_date":"2016-02-15T13:00:00Z","last_updated_date":"2016-02-15T13:00:00Z","reference_number":"EMA/HMPC/627057/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-harpagophytum-procumbens-dc-and-or-harpagophytum-zeheyri-decne-radix_en.pdf"},
    {"id":"4449","name":"Concept paper on the need to revise the guideline on the use of transgenic animals in the manufacture of biological medicinal products for human use (3ab7a of July 1995)","type":"scientific-guideline","status":"unknown","consultation_date":"2009-06-25 - 2009-09-30","first_published_date":"2009-05-20T04:00:00Z","last_updated_date":"2009-05-20T04:00:00Z","reference_number":"EMEA/CHMP/BWP/134153/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-guideline-use-transgenic-animals-manufacture-biological-medicinal-products-human-use-3ab7a-july-1995_en.pdf"},
    {"id":"4619","name":"Draft European Union herbal monograph on Pistacia lentiscus L., resin (mastic)","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-31","first_published_date":"2015-07-22T13:30:00Z","last_updated_date":"2015-07-22T13:30:00Z","reference_number":"EMA/HMPC/46758/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-pistacia-lentiscus-l-resin-mastic_en.pdf"},
    {"id":"4627","name":"Draft guideline on core summary of product characteristics for plasma-derived fibrin sealant / haemostatic products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-01-01 - 2014-03-31","first_published_date":"2011-09-27T16:17:00Z","last_updated_date":"2013-12-19T15:30:00Z","reference_number":"EMA/CHMP/BPWP/598816/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-plasma-derived-fibrin-sealant-haemostatic-products_en.pdf"},
    {"id":"4769","name":"ICH M7(R1) Addendum on application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-08-04 - 2016-02-03","first_published_date":"2015-08-04T15:00:00Z","last_updated_date":"2015-08-04T15:00:00Z","reference_number":"EMA/CHMP/ICH/458894/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m7r1-addendum-application-principles-ich-m7-guideline-calculation-compound-specific-acceptable-intakes-step-2b_en.pdf"},
    {"id":"4790","name":"Draft Community herbal monograph on Symphytum officinale L., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-08-15 - 2011-11-15","first_published_date":"2011-08-19T04:00:00Z","last_updated_date":"2011-08-19T04:00:00Z","reference_number":"EMA/HMPC/572846/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-symphytum-officinale-l-radix_en.pdf"},
    {"id":"4876","name":"Draft community herbal monograph on Capsella bursa-pastoris (L.) Medikus, herba - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-01-15 - 2011-04-15","first_published_date":"2011-01-18T02:00:00Z","last_updated_date":"2011-01-18T02:00:00Z","reference_number":"EMA/HMPC/262766/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-capsella-bursa-pastoris-l-medikus-herba-first-version_en.pdf"},
    {"id":"4913","name":"Call for scientific data for use in HMPC assessment work on Centaurium erythraea Rafn, herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-07-23 - 2014-10-31","first_published_date":"2014-07-24T18:30:00Z","last_updated_date":"2014-07-24T18:30:00Z","reference_number":"EMA/HMPC/447913/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-centaurium-erythraea-rafn-herba_en.pdf"},
    {"id":"4921","name":"Call for scientific data for the systematic review of the monograph on Betula pendula Roth; Betula pubescens Ehrh., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91037/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-betula-pendula-roth-betula-pubescens-ehrh-folium_en.pdf"},
    {"id":"4922","name":"Call for scientific data for the systematic review of the monograph on Peumus boldus Molina, folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-02-15 - 2016-05-15","first_published_date":"2016-02-15T18:45:00Z","last_updated_date":"2016-02-15T18:45:00Z","reference_number":"EMA/HMPC/129846/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-peumus-boldus-molina-folium_en.pdf"},
    {"id":"4962","name":"Paediatric investigation plan: Expected key elements and requirements for a new diphtheria-tetanus-acellular-pertussis-containing combination vaccine seeking marketing authorisation","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-09-23 - 2014-12-19","first_published_date":"2014-09-23T21:30:00Z","last_updated_date":"2014-09-23T21:30:00Z","reference_number":"EMA/PDCO/71162/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/paediatric-investigation-plan-expected-key-elements-and-requirements-new-diphtheria-tetanus-acellular-pertussis-containing-combination-vaccine-seeking-marketing-authorisation_en.pdf"},
    {"id":"4981","name":"ICH: Q 4 B Annex 12: Analytical sieving general chapter: Annex 12 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on analytical sieving general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-11-01 - 2010-02-28","first_published_date":"2009-12-18T02:00:00Z","last_updated_date":"2009-12-18T02:00:00Z","reference_number":"EMEA/CHMP/ICH/730808/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-12-analytical-sieving-general-chapter-annex-12-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-analytical-sieving-general-chapter-step-3_en.pdf"},
    {"id":"5046","name":"Concept paper on the need for revision of the position on the replacement of animal studies by in vitro models","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-17 - 2011-06-30","first_published_date":"2011-04-11T04:00:00Z","last_updated_date":"2011-04-11T04:00:00Z","reference_number":"EMA/CHMP/SWP/169839/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-position-replacement-animal-studies-vitro-models_en.pdf"},
    {"id":"5062","name":"Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-04-06 - 2018-10-30","first_published_date":"2018-04-06T17:00:00Z","last_updated_date":"2018-04-06T17:00:00Z","reference_number":"EMA/CHMP/187859/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address-paediatric-specific-clinical-data-requirements-first-version_en.pdf"},
    {"id":"5068","name":"Draft guideline on quality aspects included in the product information for vaccines for human use - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-01 - 2018-07-31","first_published_date":"2018-02-01T12:01:00Z","last_updated_date":"2018-02-01T12:01:00Z","reference_number":"EMA/CHMP/BWP/133540/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-included-product-information-vaccines-human-use-revision-1_en.pdf"},
    {"id":"5069","name":"Draft concept paper on the need for revision of the addendum on acute cardiac failure of the note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure (CPMP/EWP/2986/03)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-08-31","first_published_date":"2010-06-04T04:00:00Z","last_updated_date":"2010-06-04T04:00:00Z","reference_number":"EMA/CHMP/EWP/215701/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-addendum-acute-cardiac-failure-note-guidance-clinical-investigation-medicinal-products-treatment-cardiac-failure-cpmp-ewp-2986-03_en.pdf"},
    {"id":"5120","name":"Draft guideline on requirements for the production and control of immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-30 - 2011-09-30","first_published_date":"2011-03-30T04:00:00Z","last_updated_date":"2011-03-30T04:00:00Z","reference_number":"EMA/CVMP/IWP/206555/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-production-and-control-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"5131","name":"Draft Community list entry on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum - First version","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2013-08-21 - 2013-12-15","first_published_date":"2013-08-21T04:00:00Z","last_updated_date":"2013-08-21T04:00:00Z","reference_number":"EMA/HMPC/281620/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-and-or-other-species-melaleuca-aetheroleum-first-version_en.pdf"},
    {"id":"5166","name":"Draft vortioxetine hydrobromide, 5 mg, 10 mg, 15 mg and 20 mg immediate release tablets, vortioxetine lactate, oral drops solution 20 mg/ml product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-22 - 2017-03-31","first_published_date":"2016-12-22T14:00:00Z","last_updated_date":"2016-12-22T14:00:00Z","reference_number":"EMA/CHMP/474974/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vortioxetine-hydrobromide-5-mg-10-mg-15-mg-and-20-mg-immediate-release-tablets-vortioxetine-lactate-oral-drops-solution-20-mg-ml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"5203","name":"Draft Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-19T19:00:00Z","last_updated_date":"2011-10-19T19:00:00Z","reference_number":"EMA/HMPC/461160/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-urtica-dioica-l-urtica-urens-l-their-hybrids-or-their-mixtures-radix-first-version_en.pdf"},
    {"id":"5256","name":"Call for scientific data for use in HMPC assessment work on Fucus vesiculosus L.","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-17T19:40:00Z","last_updated_date":"2011-10-17T19:40:00Z","reference_number":"EMA/HMPC/558965/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-fucus-vesiculosus-l_en.pdf"},
    {"id":"5293","name":"Draft community herbal monograph on Viola tricolor L.","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-08-15","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/HMPC/131734/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-viola-tricolor-l_en.pdf"},
    {"id":"5369","name":"Public statement on Euphrasia officinalis L. and Euphrasia rostkoviana Hayne, herba","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2009-11-12 - 2010-05-15","first_published_date":"2010-02-12T01:09:21Z","last_updated_date":"2010-02-12T01:09:21Z","reference_number":"EMA/HMPC/727465/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-euphrasia-officinalis-l-and-euphrasia-rostkoviana-hayne-herba_en.pdf"},
    {"id":"5439","name":"Table of extraneous agents to be tested for in relation to the guideline on requirements for the production and control of immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft","consultation_date":"2012-11-15 - 2013-05-31","first_published_date":"2012-11-19T12:30:00Z","last_updated_date":"2012-11-19T12:30:00Z","reference_number":"EMA/CVMP/IWP/105112/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/table-extraneous-agents-be-tested-relation-guideline-requirements-production-and-control-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"5456","name":"Draft CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-09-30","first_published_date":"2010-07-27T04:00:00Z","last_updated_date":"2010-07-27T04:00:00Z","reference_number":"EMA/CHMP/CAT/BWP/353632/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-chmp-cat-position-statement-creutzfeldt-jakob-disease-and-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"5523","name":"Call for scientific data for the systematic review of the monograph on Arctostaphylos uva-ursi (L.) Spreng., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669365/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-arctostaphylos-uva-ursi-l-spreng-folium_en.pdf"},
    {"id":"5549","name":"Draft guideline on the evaluation of medicinal products for the treatment of chronic constipation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-03-01 - 2014-08-31","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"EMA/CHMP/336243/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-medicinal-products-treatment-chronic-constipation_en.pdf"},
    {"id":"5574","name":"Draft VICH GL50: Testing harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-08 - 2012-06-12","first_published_date":"2011-12-20T16:15:00Z","last_updated_date":"2011-12-20T16:15:00Z","reference_number":"EMA/CVMP/VICH/582610/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl50-testing-harmonisation-criteria-waive-target-animal-batch-safety-testing-inactivated-vaccines-veterinary-use-first-version_en.pdf"},
    {"id":"5598","name":"Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products in the treatment of depression with regard to treatment resistant depression - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-09-24 - 2009-12-31","first_published_date":"2000-10-09T04:00:00Z","last_updated_date":"2000-10-09T04:00:00Z","reference_number":"EMEA/CHMP/EWP/484366/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-depression-regard-treatment-resistant-depression-revision-2_en.pdf"},
    {"id":"5612","name":"Draft Community herbal monograph on Eucalyptus globulus Labill., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-04-15 - 2012-10-15","first_published_date":"2012-06-21T18:01:00Z","last_updated_date":"2012-06-21T18:01:00Z","reference_number":"EMA/HMPC/892618/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-eucalyptus-globulus-labill-folium_en.pdf"},
    {"id":"5632","name":"List of references supporting the assessment of Angelica sinensis (Oliv.) Diels, radix - First version","type":"herbal-references","status":"Draft","consultation_date":"2012-12-15 - 2013-04-15","first_published_date":"2012-12-10T18:00:00Z","last_updated_date":"2012-12-10T18:00:00Z","reference_number":"EMA/HMPC/681358/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
    {"id":"5638","name":"Second draft assessment report on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-19T04:00:00Z","last_updated_date":"2011-10-19T04:00:00Z","reference_number":"EMA/HMPC/461156/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/second-draft-assessment-report-urtica-dioica-l-urtica-urens-l-their-hybrids-or-their-mixtures-radix-first-version_en.pdf"},
    {"id":"5641","name":"Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-11-18 - 2015-02-28","first_published_date":"2014-11-18T19:11:00Z","last_updated_date":"2014-11-18T19:11:00Z","reference_number":"EMA/CVMP/EWP/309734/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-data-requirements-regarding-veterinary-medicinal-products-prevention-transmission-canine-and-feline-vector-borne-diseases_en.pdf"},
    {"id":"5735","name":"Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-02-18 - 2010-08-31","first_published_date":"2010-03-11T02:00:00Z","last_updated_date":"2010-03-11T02:00:00Z","reference_number":"EMA/CHMP/BWP/534898/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials-first-version_en.pdf"},
    {"id":"5798","name":"Draft European Union herbal monograph on Vaccinium myrtillus L., fructus siccus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-02-09 - 2015-05-15","first_published_date":"2015-02-09T12:30:00Z","last_updated_date":"2015-02-09T12:30:00Z","reference_number":"EMA/HMPC/678995/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-vaccinium-myrtillus-l-fructus-siccus_en.pdf"},
    {"id":"5801","name":"Call for scientific data for the systematic review of the monograph on Vitis vinifera L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669367/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-vitis-vinifera-l-folium_en.pdf"},
    {"id":"5810","name":"Draft concept paper on extrapolation of efficacy and safety in medicine development","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-29 - 2012-09-30","first_published_date":"2012-06-29T14:40:00Z","last_updated_date":"2012-06-29T14:40:00Z","reference_number":"EMA/129698/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-extrapolation-efficacy-and-safety-medicine-development_en.pdf"},
    {"id":"5825","name":"Concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products' - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-21 - 2016-09-30","first_published_date":"2016-07-21T16:00:00Z","last_updated_date":"2016-07-21T16:00:00Z","reference_number":"EMA/CHMP/446302/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-strategies-identify-and-mitigate-risks-first-human-clinical-trials-investigational-medicinal-products-revision-1_en.pdf"},
    {"id":"5832","name":"Concept paper on the revision of the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Superseeding document","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-24 - 2017-10-31","first_published_date":"2017-07-24T20:00:00Z","last_updated_date":"2017-07-24T20:00:00Z","reference_number":"EMA/CAT/424191/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-quality-non-clinical-and-clinical-aspects-medicinal-products-containing-genetically-modified-cells-superseeding-document_en.pdf"},
    {"id":"5836","name":"VICH Topic GL49: at step 4: Guidelines for the validation of analytical methods used in residue depletion studies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-10 - 2010-05-20","first_published_date":"2009-12-22T02:00:00Z","last_updated_date":"2010-05-10T04:00:00Z","reference_number":"EMEA/CVMP/VICH/463202/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-topic-gl49-step-4-guidelines-validation-analytical-methods-used-residue-depletion-studies_en.pdf"},
    {"id":"5909","name":"Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-12-19 - 2015-03-31","first_published_date":"2014-12-19T15:45:00Z","last_updated_date":"2014-12-19T15:45:00Z","reference_number":"EMA/CVMP/IWP/37924/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-use-heat-treatment-inactivate-retrovirus-rd114-live-immunological-veterinary-medicinal-products-ivmps_en.pdf"},
    {"id":"5918","name":"Draft Community herbal monograph on Juglans regia L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-01-15 - 2013-04-15","first_published_date":"2013-01-25T02:00:00Z","last_updated_date":"2013-01-25T02:00:00Z","reference_number":"EMA/HMPC/346737/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-juglans-regia-l-folium_en.pdf"},
    {"id":"6019","name":"Draft guideline on clinical evaluation of vaccines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-04-26 - 2018-10-30","first_published_date":"2018-04-26T21:00:00Z","last_updated_date":"2018-04-26T21:00:00Z","reference_number":"EMEA/CHMP/VWP/164653/05 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-vaccines-revision-1_en.pdf"},
    {"id":"6050","name":"Draft EMA recommendation on the procedural aspects and dossier requirements for the consultation to the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivate incorporated in a me...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2010-10-21 - 2011-01-31","first_published_date":"2010-10-22T04:00:00Z","last_updated_date":"2010-10-22T04:00:00Z","reference_number":"EMA/CHMP/578661/2010 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-ema-recommendation-procedural-aspects-and-dossier-requirements-consultation-ema-notified-body-ancillary-medicinal-substance-or-ancillary-human-blood-derivate-incorporated-me_en.pdf"},
    {"id":"6053","name":"Draft guideline on clinical investigation of medicinal products in the treatment of hypertension - Revision 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-07-31 - 2014-01-31","first_published_date":"2013-07-31T19:00:00Z","last_updated_date":"2013-07-31T19:00:00Z","reference_number":"EMA/CHMP/29947/2013/Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-hypertension-revision-4_en.pdf"},
    {"id":"6059","name":"Concept paper on revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to tre...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-11-30 - 2015-02-28","first_published_date":"2014-11-28T16:50:00Z","last_updated_date":"2014-11-28T16:50:00Z","reference_number":"EMA/CHMP/644851/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-specifically-address-clinical-development-new-agents-tre_en.pdf"},
    {"id":"6124","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-02-22 - 2013-06-30","first_published_date":"2013-02-22T14:30:00Z","last_updated_date":"2013-05-16T19:10:00Z","reference_number":"EMA/CHMP/ICH/83812/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-m7-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals_en.pdf"},
    {"id":"6137","name":"Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (1st draft)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-27 - 2018-09-30","first_published_date":"2018-06-27T14:30:00Z","last_updated_date":"2018-06-27T14:30:00Z","reference_number":"EMA/CHMP/257298/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lapatinib-film-coated-tablet-250-mg-product-specific-bioequivalence-guidance-first-version-1st-draft_en.pdf"},
    {"id":"6149","name":"Call for scientific data for use in HMPC assessment work on Aloysia citriodora Palà¡u (syn. Aloysia triphylla (L’Hà©r.) Kuntze; Verbena triphylla L’Hà©r.; Lippia citriodora Kunth.), folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/188875/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-aloysia-citriodora-palau-syn-aloysia-triphylla-lhacr-kuntze-verbena-triphylla-lhacr-lippia-citriodora-kunth-folium_en.pdf"},
    {"id":"6191","name":"Draft European Union herbal monograph on Serenoa repens (W. Bartram) Small, fructus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-12-22 - 2015-03-15","first_published_date":"2014-12-22T18:40:00Z","last_updated_date":"2014-12-22T18:40:00Z","reference_number":"EMA/HMPC/280079/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-serenoa-repens-w-bartram-small-fructus_en.pdf"},
    {"id":"6216","name":"Concept paper on the need of revision of the note for guidance: Harmonisation of requirements for equine influenza vaccines – Specific requirements for substitution or addition of a strain or strains","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-03-16 - 2012-05-31","first_published_date":"2012-03-16T10:30:00Z","last_updated_date":"2012-03-16T10:30:00Z","reference_number":"EMA/CVMP/IWP/4199/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-harmonisation-requirements-equine-influenza-vaccines-specific-requirements-substitution-or-addition-strain-or-strains_en.pdf"},
    {"id":"6286","name":"Call for scientific data for use in HMPC assessment work on Capsicum annuum L. var. minimum (Miller) Heiser and Capsicum frutescens L., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-07-15","first_published_date":"2011-04-14T04:00:00Z","last_updated_date":"2011-04-14T04:00:00Z","reference_number":"EMA/HMPC/129733/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-capsicum-annuum-l-var-minimum-miller-heiser-and-capsicum-frutescens-l-fructus_en.pdf"},
    {"id":"6328","name":"Draft reflection paper on in-vitro cultured Chondrocyte containing products for cartilage repair of the knee","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-09-11 - 2009-12-31","first_published_date":"2009-09-17T04:00:00Z","last_updated_date":"2009-10-05T04:00:00Z","reference_number":"EMEA/CAT/CPWP/288934/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-vitro-cultured-chondrocyte-containing-products-cartilage-repair-knee_en.pdf"},
    {"id":"6378","name":"Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-30 - 2018-01-31","first_published_date":"2017-10-30T14:30:00Z","last_updated_date":"2017-10-30T14:30:00Z","reference_number":"EMA/CHMP/BPWP/1619/1999 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-plasma-derived-and-recombinant-coagulation-factor-viii-products-revision-3_en.pdf"},
    {"id":"6412","name":"Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-12-15 - 2018-03-31","first_published_date":"2017-12-15T17:00:00Z","last_updated_date":"2017-12-15T17:00:00Z","reference_number":"EMA/CVMP/EWP/158889/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-summary-product-characteristics-anthelmintics_en.pdf"},
    {"id":"6419","name":"Call for scientific data for use in HMPC assessment work on Glycine max and/or lecithin derived from Glycine max (soy bean lecithin)","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-06-15","first_published_date":"2014-02-17T11:35:00Z","last_updated_date":"2014-04-15T15:10:00Z","reference_number":"EMA/HMPC/87618/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-glycine-max-and-or-lecithin-derived-glycine-max-soy-bean-lecithin_en.pdf"},
    {"id":"6426","name":"Consultation on qualification opinion ILSI / HESI submission of novel renal biomarkers for toxicity","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-03-18 - 2010-07-31","first_published_date":"2010-05-11T04:00:00Z","last_updated_date":"2010-06-07T04:00:00Z","reference_number":"EMA/283298/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/consultation-qualification-opinion-ilsi-hesi-submission-novel-renal-biomarkers-toxicity_en.pdf"},
    {"id":"6445","name":"Draft reflection paper on the data requirements for intravenous liposomal products developed with reference to an innovator liposomal product","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-07-21 - 2012-01-31","first_published_date":"2011-07-26T04:00:00Z","last_updated_date":"2011-07-26T04:00:00Z","reference_number":"EMA/CHMP/806058/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-data-requirements-intravenous-liposomal-products-developed-reference-innovator-liposomal-product_en.pdf"},
    {"id":"6463","name":"Reflection paper on classification of advanced-therapy medicinal products","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2012-04-30 - 2012-07-31","first_published_date":"2012-04-30T22:13:50Z","last_updated_date":"2012-04-30T22:13:50Z","reference_number":"EMA/CAT/600280/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-classification-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"6525","name":"Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-02-16 - 2017-05-16","first_published_date":"2017-02-16T13:16:00Z","last_updated_date":"2017-02-16T13:16:00Z","reference_number":"EMA/CHMP/QWP/BWP/661488/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-developing-guideline-quality-requirements-medicinal-products-containing-device-component-delivery-or-use-medicinal-product_en.pdf"},
    {"id":"6527","name":"Call for scientific data for use in HMPC assessment work on Sideritis herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-17T11:00:00Z","last_updated_date":"2014-02-17T11:00:00Z","reference_number":"EMA/HMPC/87641/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-sideritis-herba_en.pdf"},
    {"id":"6540","name":"Draft guideline on the design of studies to evaluate the safety and efficacy of fish vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-30 - 2011-09-30","first_published_date":"2011-03-30T04:00:00Z","last_updated_date":"2011-03-30T04:00:00Z","reference_number":"EMA/CVMP/IWP/314550/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-design-studies-evaluate-safety-and-efficacy-fish-vaccines_en.pdf"},
    {"id":"6585","name":"Draft guideline on core summary of product characteristics and package leaflet for sodium fluoride (18F)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-31 - 2014-10-31","first_published_date":"2014-07-31T19:50:00Z","last_updated_date":"2014-07-31T19:50:00Z","reference_number":"EMA/CHMP/465616/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-and-package-leaflet-sodium-fluoride-18f_en.pdf"},
    {"id":"6588","name":"Draft European Union herbal monograph on Hedera helix L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-02-12 - 2015-05-15","first_published_date":"2010-03-08T02:00:00Z","last_updated_date":"2015-02-12T15:30:00Z","reference_number":"EMA/HMPC/586888/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-hedera-helix-l-folium_en.pdf"},
    {"id":"6661","name":"Concept paper on a revision of the guideline on the investigation of drug interactions","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-07 - 2017-06-30","first_published_date":"2017-04-07T13:10:00Z","last_updated_date":"2017-04-07T13:10:00Z","reference_number":"EMEA/CHMP/694687/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-investigation-drug-interactions_en.pdf"},
    {"id":"6697","name":"Draft qualification opinion on molecular neuroimaging of the dopamine transporter as biomarker to identify patients with early manifest Parkinsonism in Parkinson’s disease","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-24 - 2018-03-07","first_published_date":"2018-01-24T18:00:00Z","last_updated_date":"2018-01-24T18:00:00Z","reference_number":"EMA/765041/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-molecular-neuroimaging-dopamine-transporter-biomarker-identify-patients-early-manifest-parkinsonism-parkinsons-disease_en.pdf"},
    {"id":"6814","name":"Draft guideline on core SmPC and package leaflet for gadoteric acid","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-06-01 - 2016-09-30","first_published_date":"2016-06-01T18:00:02Z","last_updated_date":"2016-06-01T18:00:02Z","reference_number":"EMA/CHMP/337820/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-gadoteric-acid_en.pdf"},
    {"id":"6865","name":"Draft guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004 (Revision 1)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-27 - 2015-09-30","first_published_date":"2015-07-27T15:00:00Z","last_updated_date":"2015-07-27T15:00:00Z","reference_number":"EMA/CHMP/697051/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-scientific-application-and-practical-arrangements-necessary-implement-procedure-accelerated-assessment-pursuant-article-149-regulation-ec-no-726-2004-revision-1_en.pdf"},
    {"id":"6903","name":"Draft public statement on Glycine max (L.) Merr., semen - First version","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2017-02-28 - 2017-05-31","first_published_date":"2017-02-28T10:30:00Z","last_updated_date":"2017-02-28T10:30:00Z","reference_number":"EMA/HMPC/461814/2016","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-glycine-max-l-merr-semen-first-version_en.pdf"},
    {"id":"7057","name":"Overview of comments received on Guideline on risk characterisation and assessment of maximum residue limits (MRL) for biocides","type":"comments","status":"unknown","consultation_date":"2015-01-27 - 2015-04-30","first_published_date":"2015-01-30T02:00:00Z","last_updated_date":"2015-01-30T02:00:00Z","reference_number":"EMA/CVMP/SWP/33896/2013","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-risk-characterisation-and-assessment-maximum-residue-limits-mrl-biocides_en.pdf"},
    {"id":"7096","name":"Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-07-14 - 2010-10-31","first_published_date":"2009-03-16T02:00:00Z","last_updated_date":"2010-07-19T04:00:00Z","reference_number":"EMEA/CVMP/016/00 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-2_en.pdf"},
    {"id":"7104","name":"Call for scientific data for the review of the HMPC assessment on Angelica sinensis (Oliv.) Diels, radix - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/248608/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-review-hmpc-assessment-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
    {"id":"7116","name":"Draft guideline on influenza vaccines – quality module","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-08 - 2013-08-08","first_published_date":"2013-03-08T12:00:00Z","last_updated_date":"2013-03-08T12:00:00Z","reference_number":"EMA/CHMP/BWP/310834/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-influenza-vaccines-quality-module_en.pdf"},
    {"id":"7139","name":"Draft guidance on the assessment of persistent, bioaccumulative and toxic or very persistent and very bioaccumulative substances in veterinary medicine","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-27 - 2015-01-27","first_published_date":"2012-07-25T14:40:00Z","last_updated_date":"2014-10-27T10:55:00Z","reference_number":"EMA/CVMP/ERA/52740/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guidance-assessment-persistent-bioaccumulative-and-toxic-or-very-persistent-and-very-bioaccumulative-substances-veterinary-medicine_en.pdf"},
    {"id":"7161","name":"Draft community herbal monograph on Potentilla erecta (L.) Raeusch., rhizoma","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-08-15","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/HMPC/5513/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-potentilla-erecta-l-raeusch-rhizoma_en.pdf"},
    {"id":"7215","name":"Draft guideline on procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure - Revision 1 - Superseded","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-09-01","first_published_date":"2010-06-02T04:00:00Z","last_updated_date":"2010-06-02T04:00:00Z","reference_number":"EMA/CHMP/BWP/99698/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-procedural-advice-submission-variations-annual-update-human-influenza-inactivated-vaccines-applications-centralised-procedure-revision-1-superseded_en.pdf"},
    {"id":"7243","name":"Consultation procedure - Public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird popula...","type":"other","status":"Draft: consultation closed","consultation_date":"2014-09-12 - 2014-10-10","first_published_date":"2014-09-12T21:30:00Z","last_updated_date":"2014-09-12T21:30:00Z","reference_number":"EMA/545597/2014","document_url":"https://www.ema.europa.eu/en/documents/other/consultation-procedure-public-consultation-regarding-request-european-medicines-agency-european-commission-scientific-opinion-regarding-risks-vultures-and-other-necrophagous-bird-popula_en.pdf"},
    {"id":"7251","name":"Call for scientific data for use in HMPC assessment work on Malva sylvestris L., folium and flos - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669364/2015 Corr","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-malva-sylvestris-l-folium-and-flos-first-version_en.pdf"},
    {"id":"7305","name":"Draft Community herbal monograph on Arnica montana L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-08-22 - 2013-12-15","first_published_date":"2013-08-22T04:00:00Z","last_updated_date":"2013-08-22T04:00:00Z","reference_number":"EMA/HMPC/198793/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-arnica-montana-l-flos_en.pdf"},
    {"id":"7314","name":"Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"2012-07-26 - 2012-09-21","first_published_date":"2012-12-13T18:00:00Z","last_updated_date":"2012-12-13T18:00:00Z","reference_number":"EMA/228028/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-iv-pharmacovigilance-audits-superseded_en.pdf"},
    {"id":"7342","name":"Draft Community herbal monograph on Aesculus hippocastanum L., cortex","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-26T14:30:01Z","last_updated_date":"2011-10-26T14:30:01Z","reference_number":"EMA/HMPC/354156/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-aesculus-hippocastanum-l-cortex_en.pdf"},
    {"id":"7385","name":"Draft public statement on Viscum album L., herba","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-20T13:30:15Z","last_updated_date":"2011-10-20T13:30:15Z","reference_number":"EMA/HMPC/57109/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-viscum-album-l-herba_en.pdf"},
    {"id":"7503","name":"Draft Community herbal monograph on Matricaria recutita L., aetheroleum - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-07-24 - 2014-10-31","first_published_date":"2014-07-24T19:50:00Z","last_updated_date":"2014-07-24T19:50:00Z","reference_number":"EMA/HMPC/278814/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-matricaria-recutita-l-aetheroleum-first-version_en.pdf"},
    {"id":"7532","name":"Draft capecitabine product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423732/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-capecitabine-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"7564","name":"Draft guideline on requirements for the production and control of immunological veterinary medicinal products - Rev.1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-17 - 2016-01-31","first_published_date":"2015-07-17T13:15:00Z","last_updated_date":"2015-07-17T13:15:00Z","reference_number":"EMA/CVMP/IWP/206555/2010-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-production-and-control-immunological-veterinary-medicinal-products-rev1_en.pdf"},
    {"id":"7585","name":"Draft guideline on good pharmacovigilance practices: Module VIII - Post-authorisation safety studies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/813938/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-viii-post-authorisation-safety-studies_en.pdf"},
    {"id":"7680","name":"Draft guideline on core summary of product characteristics and package leaflet for technetium (99mTc) sestamibi","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-08-23 - 2012-11-30","first_published_date":"2012-08-23T15:00:00Z","last_updated_date":"2012-08-23T15:00:00Z","reference_number":"EMA/CHMP/448591/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-and-package-leaflet-technetium-99mtc-sestamibi_en.pdf"},
    {"id":"7807","name":"Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-13 - 2018-09-13","first_published_date":"2018-06-13T19:35:00Z","last_updated_date":"2018-06-13T19:35:00Z","reference_number":"EMA/CHMP/75653/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-preparation-revised-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-3_en.pdf"},
    {"id":"7808","name":"Call for scientific data for use in HMPC assessment work on Cetraria islandica (L.) Acharius s.l. - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648703/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-cetraria-islandica-l-acharius-sl-first-version_en.pdf"},
    {"id":"7816","name":"Procedural advice on the consultation of Notified Bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2010-07-16 - 2010-10-29","first_published_date":"2010-07-29T04:00:00Z","last_updated_date":"2010-07-29T04:00:00Z","reference_number":"EMA/354785/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-consultation-notified-bodies-accordance-article-9-regulation-ec-no-1394-2007_en.pdf"},
    {"id":"7838","name":"Call for scientific data for the systematic review of the monograph on Echinacea purpurea (L.) Moench, herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91101/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-echinacea-purpurea-l-moench-herba_en.pdf"},
    {"id":"7871","name":"Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-25 - 2016-10-31","first_published_date":"2016-07-25T14:29:00Z","last_updated_date":"2016-07-25T14:29:00Z","reference_number":"EMA/CVMP/AWP/161553/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-current-guideline-summary-product-characteristics-antimicrobial-products_en.pdf"},
    {"id":"7897","name":"Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-07 - 2011-05-31","first_published_date":"2011-02-22T02:00:00Z","last_updated_date":"2011-02-22T02:00:00Z","reference_number":"EMA/CHMP/BWP/617111/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-quality-issues_en.pdf"},
    {"id":"7967","name":"Draft Community herbal monograph on Sisymbrium officinale (L.) Scop., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-01-15 - 2014-04-15","first_published_date":"2014-01-17T02:00:00Z","last_updated_date":"2014-01-17T02:00:00Z","reference_number":"EMA/HMPC/280193/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"8048","name":"Draft assessment report on Fumaria officinalis L., herba","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-04-04T04:00:00Z","last_updated_date":"2011-04-04T04:00:00Z","reference_number":"EMA/HMPC/576232/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-fumaria-officinalis-l-herba_en.pdf"},
    {"id":"8250","name":"Draft guideline on the use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-09-28 - 2016-03-31","first_published_date":"2015-09-28T18:30:00Z","last_updated_date":"2015-09-28T18:30:00Z","reference_number":"EMA/CHMP/594085/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-pharmacokinetics-and-pharmacodynamics-development-antibacterial-medicinal-products_en.pdf"},
    {"id":"8274","name":"Draft guideline on clinical development of fixed combination medicinal products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-05-13 - 2015-11-15","first_published_date":"2015-05-13T14:30:00Z","last_updated_date":"2015-05-13T14:30:00Z","reference_number":"EMA/CHMP/281825/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-fixed-combination-medicinal-products-revision-2_en.pdf"},
    {"id":"8308","name":"Call for scientific data for use in HMPC assessment work on Piper methysticum G. Forst., rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-05-28 - 2015-08-31","first_published_date":"2015-05-28T13:20:00Z","last_updated_date":"2015-05-28T13:20:00Z","reference_number":"EMA/HMPC/343245/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-piper-methysticum-g-forst-rhizoma_en.pdf"},
    {"id":"8310","name":"Draft public statement on Sambucus nigra L., fructus","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2013-03-12 - 2013-07-15","first_published_date":"2013-04-19T04:00:00Z","last_updated_date":"2013-04-19T04:00:00Z","reference_number":"EMA/HMPC/32465/2013","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"8349","name":"Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-27 - 2012-08-31","first_published_date":"2012-02-27T18:40:00Z","last_updated_date":"2012-02-27T18:40:00Z","reference_number":"EMA/CHMP/BWP/729106/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-starting-materials-and-intermediates-collected-different-sources-manufacturing-biological-medicinal-products_en.pdf"},
    {"id":"8411","name":"Concept paper on revision of note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use (CPMP/BPWG/283/00)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-12-16 - 2011-03-31","first_published_date":"2010-12-17T02:00:00Z","last_updated_date":"2010-12-17T02:00:00Z","reference_number":"EMA/CHMP/BPWP/761007/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-clinical-investigation-human-normal-immunoglobulin-subcutaneous-and-intramuscular-use-cpmp-bpwg-283-00_en.pdf"},
    {"id":"8421","name":"Draft guideline on the treatment of Premenstrual Dysphoric Disorder (PMDD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-11-30","first_published_date":"2010-05-24T04:00:00Z","last_updated_date":"2010-05-24T04:00:00Z","reference_number":"EMA/CHMP/EWP/607022/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-treatment-premenstrual-dysphoric-disorder-pmdd_en.pdf"},
    {"id":"8429","name":"Draft addendum to the 'guideline on the evaluation of medicinal products indicated for treatment of bacterial infections' to address the clinical development of new agents to treat disease due to Mycobacterium tuberculos...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2017-01-31","first_published_date":"2016-08-01T16:00:00Z","last_updated_date":"2016-08-01T16:00:00Z","reference_number":"EMA/CHMP/EWP/14377/2008 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address-clinical-development-new-agents-treat-disease-due-mycobacterium-tuberculos_en.pdf"},
    {"id":"8435","name":"Draft information in the package leaflet for fragrances containing allergens in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-04 - 2016-08-03","first_published_date":"2016-05-04T17:00:00Z","last_updated_date":"2016-05-04T17:00:00Z","reference_number":"EMA/CHMP/273718/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-fragrances-containing-allergens-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-cpmp-463_en.pdf"},
    {"id":"8498","name":"Concept paper on the revision of the guideline on  immunogenicity assessment of biotechnology-derived  therapeutic proteins - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-03-25 - 2014-06-30","first_published_date":"2014-03-25T10:55:00Z","last_updated_date":"2014-03-25T10:55:00Z","reference_number":"EMA/275542/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-revision-1_en.pdf"},
    {"id":"8536","name":"Draft public statement on Allium cepa L., bulbus","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-08-15 - 2011-11-15","first_published_date":"2011-08-18T04:00:00Z","last_updated_date":"2011-08-18T04:00:00Z","reference_number":"EMA/HMPC/347189/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-allium-cepa-l-bulbus_en.pdf"},
    {"id":"8563","name":"Draft VICH GL56 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing maximum residue limits and...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-02-24 - 2017-07-31","first_published_date":"2017-02-24T18:00:00Z","last_updated_date":"2017-02-24T18:00:00Z","reference_number":"EMA/CVMP/VICH/176637/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl56-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-species-study-design-recommendations-residue-studies-honey-establishing-maximum-residue-limits-and_en.pdf"},
    {"id":"8579","name":"Draft paliperidone prolonged-release tablet 1.5mg, 3mg, 6mg, 9mg and 12mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-02 - 2016-07-31","first_published_date":"2016-05-02T13:00:00Z","last_updated_date":"2016-05-02T13:00:00Z","reference_number":"EMA/CHMP/156358/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paliperidone-prolonged-release-tablet-15mg-3mg-6mg-9mg-and-12mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"8592","name":"Draft reflection paper on the pharmaceutical development of medicines for use in the older population - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-01 - 2018-01-31","first_published_date":"2017-08-01T16:15:00Z","last_updated_date":"2017-08-01T16:15:00Z","reference_number":"EMA/CHMP/QWP/292439/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-pharmaceutical-development-medicines-use-older-population-first-version_en.pdf"},
    {"id":"8611","name":"Guideline on good pharmacovigilance practices: Module X – Additional monitoring","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-06-27 - 2012-08-24","first_published_date":"2013-04-25T14:00:00Z","last_updated_date":"2013-04-25T14:00:00Z","reference_number":"EMA/169546/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-x-additional-monitoring_en.pdf"},
    {"id":"8792","name":"Draft guideline on lipid lowering agents - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-11-18 - 2011-05-31","first_published_date":"2010-12-21T02:00:00Z","last_updated_date":"2010-12-21T02:00:00Z","reference_number":"EMA/CPMP/3020/2003","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-lipid-lowering-agents-revision-1_en.pdf"},
    {"id":"8824","name":"Draft assessment report on Achillea millefolium L., herba","type":"herbal-report","status":"Draft","consultation_date":"2010-11-15 - 2011-02-15","first_published_date":"2010-11-09T02:00:00Z","last_updated_date":"2010-11-09T02:00:00Z","reference_number":"EMA/HMPC/290309/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-achillea-millefolium-l-herba_en.pdf"},
    {"id":"8906","name":"Call for scientific data for use in HMPC assessment work on Paullinia cupana Kunth, semen - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-07-15","first_published_date":"2011-04-14T04:00:00Z","last_updated_date":"2011-04-14T04:00:00Z","reference_number":"EMA/HMPC/278492/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-paullinia-cupana-kunth-semen-first-version_en.pdf"},
    {"id":"8913","name":"Concept paper on the need for the guidance on the clinical investigation of medicinal products to slow progression of renal insufficiency","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-07-22 - 2011-01-01","first_published_date":"2010-09-20T04:00:00Z","last_updated_date":"2010-09-20T04:00:00Z","reference_number":"EMA/CHMP/EWP/6054/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guidance-clinical-investigation-medicinal-products-slow-progression-renal-insufficiency_en.pdf"},
    {"id":"8926","name":"Draft guideline on multiplicity issues in clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-01 - 2017-06-30","first_published_date":"2017-03-31T21:40:00Z","last_updated_date":"2017-03-31T21:40:00Z","reference_number":"EMA/CHMP/44762/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-multiplicity-issues-clinical-trials_en.pdf"},
    {"id":"8955","name":"Concept paper for the revision of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-29 - 2016-07-31","first_published_date":"2016-04-29T18:25:00Z","last_updated_date":"2016-04-29T18:25:00Z","reference_number":"EMA/CVMP/EWP/707453/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-cvmp-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-3_en.pdf"},
    {"id":"8973","name":"Superseding version - Draft revised recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data for centrally authorised products (CAPs)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-02-24 - 2017-08-31","first_published_date":"2017-02-24T18:00:00Z","last_updated_date":"2017-02-24T18:00:00Z","reference_number":"EMA/CVMP/PhVWP/171122/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/superseding-version-draft-revised-recommendation-basic-surveillance-eudravigilance-veterinary-evvet-data-centrally-authorised-products-caps_en.pdf"},
    {"id":"8984","name":"Draft guideline on core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) - Rev.5","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-01-01 - 2017-03-31","first_published_date":"2016-12-22T12:30:00Z","last_updated_date":"2016-12-22T12:30:00Z","reference_number":"EMA/CHMP/BPWP/94038/2007 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-human-normal-immunoglobulin-intravenous-administration-ivig-rev5_en.pdf"},
    {"id":"9049","name":"Draft guideline on core summary of product characteristics and package leaflet for fludeoxyglucose (18F)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-12 - 2011-12-31","first_published_date":"2011-10-03T13:38:00Z","last_updated_date":"2011-10-03T13:38:00Z","reference_number":"EMA/547466/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-and-package-leaflet-fludeoxyglucose-18f_en.pdf"},
    {"id":"9092","name":"Call for scientific data for the systematic review of the monograph on Cassia senna L.; Cassia angustifolia Vahl, folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648291/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-cassia-senna-l-cassia-angustifolia-vahl-folium_en.pdf"},
    {"id":"9117","name":"Draft dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-28 - 2017-10-31","first_published_date":"2017-07-28T14:00:00Z","last_updated_date":"2017-07-28T14:00:00Z","reference_number":"EMA/CHMP/356874/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dolutegravir-film-coated-tablets-10-mg-25-mg-and-50-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"9119","name":"Draft guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-20 - 2015-09-30","first_published_date":"2015-03-20T17:00:00Z","last_updated_date":"2015-03-20T17:00:00Z","reference_number":"EMEA/CVMP/EWP/005/2000 - Rev.3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-testing-and-evaluation-efficacy-antiparasitic-substances-treatment-and-prevention-tick-and-flea-infestation-dogs-and-cats-revision-3_en.pdf"},
    {"id":"9139","name":"Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-06-09 - 2011-11-25","first_published_date":"2011-07-12T05:00:00Z","last_updated_date":"2011-07-12T05:00:00Z","reference_number":"EMA/446337/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-methodological-issues-associated-pharmacogenomic-biomarkers-relation-clinical-development-and-patient-selection_en.pdf"},
    {"id":"9179","name":"Draft community herbal monograph on Cola nitida (Vent.) Schott et Endl. and its varieties and Cola acuminata (P. Beauv.) Schott et Endl., semen","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-08-15","first_published_date":"2011-04-20T04:00:00Z","last_updated_date":"2011-04-20T04:00:00Z","reference_number":"EMA/HMPC/722367/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cola-nitida-vent-schott-et-endl-and-its-varieties-and-cola-acuminata-p-beauv-schott-et-endl-semen_en.pdf"},
    {"id":"9193","name":"Guideline on good pharmacovigilance practices: Module VIII – Post-authorisation safety studies (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T04:00:00Z","last_updated_date":"2012-06-25T04:00:00Z","reference_number":"EMA/813938/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-viii-post-authorisation-safety-studies-superseded_en.pdf"},
    {"id":"9308","name":"Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 370","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-26 - 2017-08-31","first_published_date":"2017-04-26T19:30:00Z","last_updated_date":"2017-04-26T19:30:00Z","reference_number":"EMA/CHMP/813144/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-guideline-core-summary-product-characteristics-smpc-and-package-leaflet-iopamidol-370_en.pdf"},
    {"id":"9387","name":"Call for scientific data for use in HMPC assessment work on Ononis spinosa L. and Ononis arvensis L., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-02-15 - 2012-05-15","first_published_date":"2012-02-15T18:00:00Z","last_updated_date":"2012-02-15T18:00:00Z","reference_number":"EMA/HMPC/66224/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-ononis-spinosa-l-and-ononis-arvensis-l-radix_en.pdf"},
    {"id":"9439","name":"Draft community herbal monograph on Quercus robur L., Quercus petraea (Matt.) Liebl. and Quercus pubescens Willd., cortex","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-01-14 - 2010-05-15","first_published_date":"2010-03-08T02:00:00Z","last_updated_date":"2010-03-08T02:00:00Z","reference_number":"EMA/HMPC/3203/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-quercus-robur-l-quercus-petraea-matt-liebl-and-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"9479","name":"Draft Community herbal monograph on Ginkgo biloba L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-06-15","first_published_date":"2014-02-14T02:00:00Z","last_updated_date":"2014-02-14T02:00:00Z","reference_number":"EMA/HMPC/321097/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-ginkgo-biloba-l-folium_en.pdf"},
    {"id":"9481","name":"Draft guideline on the clinical investigation of hepatitis-B immunoglobulins","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-12-03 - 2013-06-03","first_published_date":"2012-12-03T11:24:00Z","last_updated_date":"2012-12-03T11:24:00Z","reference_number":"EMA/CHMP/BPWP/585257/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-hepatitis-b-immunoglobulins_en.pdf"},
    {"id":"9484","name":"Draft vismodegib hard capsule 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-31 - 2018-04-30","first_published_date":"2018-01-31T14:15:00Z","last_updated_date":"2018-01-31T14:15:00Z","reference_number":"EMA/CHMP/800794/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vismodegib-hard-capsule-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"9485","name":"Electronic common technical document v4.0 draft European Union module 1 implementation guide public consultation","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-13 - 2015-05-22","first_published_date":"2015-03-16T14:00:00Z","last_updated_date":"2015-03-16T14:00:00Z","reference_number":"EMA/170681/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-common-technical-document-v40-draft-european-union-module-1-implementation-guide-public-consultation_en.pdf"},
    {"id":"9536","name":"Draft European Union herbal monograph on Valeriana officinalis L.,  aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-31","first_published_date":"2015-07-23T04:00:00Z","last_updated_date":"2015-07-23T04:00:00Z","reference_number":"EMA/HMPC/278053/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-valeriana-officinalis-l-aetheroleum_en.pdf"},
    {"id":"9603","name":"Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure","type":"scientific-guideline","status":"Adopted","consultation_date":"2015-12-18 - 2016-03-31","first_published_date":"2015-12-18T11:00:01Z","last_updated_date":"2016-07-25T18:50:00Z","reference_number":"EMA/CVMP/550607/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-mentioning-solvents-product-information-veterinary-medicinal-products-authorised-centralised-procedure_en.pdf"},
    {"id":"9682","name":"Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q3D (R1) on elemental impurities - Step 2b - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-05-16 - 2018-08-16","first_published_date":"2018-05-16T15:39:00Z","last_updated_date":"2018-05-16T15:39:00Z","reference_number":"EMA/CHMP/ICH/353369/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q3d-r1-elemental-impurities-step-2b-revision-1_en.pdf"},
    {"id":"9685","name":"Draft European Union herbal monograph on Vitis vinifera L., folium","type":"herbal-monograph","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:54:00Z","last_updated_date":"2016-12-15T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-vitis-vinifera-l-folium_en.pdf"},
    {"id":"9728","name":"Draft public statement on Paeonia lactiflora Pall. and Paeonia veitchii Lynch, radix (Paeoniae radix rubra)","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2016-02-16 - 2016-05-15","first_published_date":"2016-02-16T18:40:00Z","last_updated_date":"2016-02-16T18:40:00Z","reference_number":"EMA/HMPC/762952/2015","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-paeonia-lactiflora-pall-and-paeonia-veitchii-lynch-radix-paeoniae-radix-rubra_en.pdf"},
    {"id":"9763","name":"VICH Topic GL48: at step 4: Guideline on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-10 - 2010-05-20","first_published_date":"2009-12-22T02:00:00Z","last_updated_date":"2010-05-10T04:00:00Z","reference_number":"EMEA/CVMP/VICH/463199/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-topic-gl48-step-4-guideline-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-animals-marker-residue-depletion-studies-establish-product-withdrawal-periods_en.pdf"},
    {"id":"9764","name":"Draft Community herbal monograph on Lavandula angustifolia P. Mill., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-08-15","first_published_date":"2011-02-11T02:00:00Z","last_updated_date":"2011-06-16T04:00:00Z","reference_number":"EMA/HMPC/734125/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-lavandula-angustifolia-p-mill-flos_en.pdf"},
    {"id":"9851","name":"Call for scientific data for the systematic review of the monograph on Cassia senna L.; Cassia angustifolia Vahl, fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648271/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-cassia-senna-l-cassia-angustifolia-vahl-fructus_en.pdf"},
    {"id":"9889","name":"Draft guideline on the investigation of subgroups in confirmatory clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-03 - 2014-07-31","first_published_date":"2014-02-03T17:10:00Z","last_updated_date":"2014-02-03T17:10:00Z","reference_number":"EMA/CHMP/539146/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf"},
    {"id":"9906","name":"General criteria for granting free scientific advice in respect of supporting the research and development of veterinary medicinal products destined for minor use in major species and minor species","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"2004-02-13 - 2004-03-13","first_published_date":"2004-05-12T04:00:00Z","last_updated_date":"2004-05-12T04:00:00Z","reference_number":"EMEA/CVMP/1136/03-FINAL","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/general-criteria-granting-free-scientific-advice-respect-supporting-research-and-development-veterinary-medicinal-products-destined-minor-use-major-species-and-minor-species_en.pdf"},
    {"id":"9913","name":"Overview of comments received on 'Reflection paper on the risk of antimicrobial resistance transfer from companion animals'","type":"comments","status":"unknown","consultation_date":"2015-01-27 - 2015-04-30","first_published_date":"2015-01-30T02:00:00Z","last_updated_date":"2015-01-30T02:00:00Z","reference_number":"EMA/CVMP/89283/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-reflection-paper-risk-antimicrobial-resistance-transfer-companion-animals_en.pdf"},
    {"id":"9920","name":"Call for scientific data for the review of the HMPC assessment on Andrographis paniculata Nees, folium - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/248556/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-review-hmpc-assessment-andrographis-paniculata-nees-folium-first-version_en.pdf"},
    {"id":"9987","name":"Draft list of references supporting the assessment of Olea europaea L., folium","type":"herbal-references","status":"Draft","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-07-14T04:00:00Z","last_updated_date":"2011-07-14T04:00:00Z","reference_number":"EMA/HMPC/430505/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-olea-europaea-l-folium_en.pdf"},
    {"id":"10093","name":"Draft assessment report on Piper methysticum G. Forst., rhizoma","type":"herbal-report","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:35:00Z","last_updated_date":"2016-12-15T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-piper-methysticum-g-forst-rhizoma_en.pdf"},
    {"id":"10139","name":"Draft Community herbal monograph on Grindelia robusta Nutt., Grindelia squarrosa (Pursh) Dunal, Grindelia humilis Hook. et Arn., Grindelia camporum Greene, herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-04-15 - 2012-08-15","first_published_date":"2012-05-16T04:00:00Z","last_updated_date":"2012-05-16T04:00:00Z","reference_number":"EMA/HMPC/748220/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-grindelia-robusta-nutt-grindelia-squarrosa-pursh-dunal-grindelia-humilis-hook-et-arn-grindelia-camporum-greene-herba_en.pdf"},
    {"id":"10142","name":"Concept paper on the development of a guideline on quality and equivalence of topical products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-22 - 2015-07-22","first_published_date":"2015-04-22T15:00:00Z","last_updated_date":"2015-04-22T15:00:00Z","reference_number":"EMA/CHMP/QWP/558185/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-quality-and-equivalence-topical-products_en.pdf"},
    {"id":"10160","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-28 - 2016-10-31","first_published_date":"2016-07-28T18:45:00Z","last_updated_date":"2018-02-07T16:45:00Z","reference_number":"EMA/317855/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-or-prevention-diabetes-mellitus_en.pdf"},
    {"id":"10215","name":"ICH S9 guideline on nonclinical evaluation for anticancer 4 pharmaceuticals - questions and answers - Step 2b","type":"scientific-guideline","status":"unknown","consultation_date":"2016-07-28 - 2017-01-28","first_published_date":"2016-07-28T19:35:00Z","last_updated_date":"2016-09-22T19:35:00Z","reference_number":"EMA/CHMP/ICH/453684/2016 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s9-guideline-nonclinical-evaluation-anticancer-4-pharmaceuticals-questions-and-answers-step-2b_en.pdf"},
    {"id":"10301","name":"Draft guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-01 - 2018-05-01","first_published_date":"2018-02-01T16:00:00Z","last_updated_date":"2018-02-01T16:00:00Z","reference_number":"EMEA/149995/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-and-efficacy-follow-and-risk-management-advanced-therapy-medicinal-products-revision-1_en.pdf"},
    {"id":"10418","name":"Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of cystic fibrosis (CHMP/EWP/9147/2008) - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-10-31","first_published_date":"2016-08-01T18:30:00Z","last_updated_date":"2016-08-01T18:30:00Z","reference_number":"EMA/CHMP/259918/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-development-medicinal-products-treatment-cystic-fibrosis-chmp-ewp-9147-2008-revision-1_en.pdf"},
    {"id":"10478","name":"Call for scientific data for the systematic review of the monograph on Linum usitatissimum L., semen","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558977/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-linum-usitatissimum-l-semen_en.pdf"},
    {"id":"10506","name":"Draft sitagliptin film-coated tablets 25, 50 and 100 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-15 - 2015-11-01","first_published_date":"2015-07-15T14:00:02Z","last_updated_date":"2015-07-15T14:00:02Z","reference_number":"EMA/CHMP/PKWP/36869/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-sitagliptin-film-coated-tablets-25-50-and-100-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"10550","name":"Principles on assignment of defined daily dose for animals and defined course dose for animals - draft","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-16 - 2015-05-12","first_published_date":"2015-03-16T14:10:00Z","last_updated_date":"2015-03-16T14:10:00Z","reference_number":"EMA/710019/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/principles-assignment-defined-daily-dose-animals-and-defined-course-dose-animals-draft_en.pdf"},
    {"id":"10576","name":"Draft community herbal monograph on Fumaria officinalis L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-02-11T02:00:00Z","last_updated_date":"2011-02-11T02:00:00Z","reference_number":"EMA/HMPC/574766/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-fumaria-officinalis-l-herba_en.pdf"},
    {"id":"10760","name":"Draft European Union list entry on Crataegus spp., folium cum flore","type":"other","status":"Draft: consultation closed","consultation_date":"2015-02-09 - 2015-05-16","first_published_date":"2015-02-09T02:00:00Z","last_updated_date":"2015-02-09T02:00:00Z","reference_number":"EMA/HMPC/685372/2014","document_url":"https://www.ema.europa.eu/en/documents/other/draft-european-union-list-entry-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"10819","name":"Draft ticagrelor film-coated tablets 90mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-01 - 2016-01-01","first_published_date":"2015-10-06T17:00:00Z","last_updated_date":"2015-10-06T17:00:00Z","reference_number":"EMA/CHMP/PKWP/151478/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ticagrelor-film-coated-tablets-90mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"10852","name":"Draft questions and answers on the template for the Qualified Person’s (QP's) declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply...","type":"other","status":"Draft: consultation closed","consultation_date":"2010-12-16 - 2011-04-30","first_published_date":"2011-01-13T02:00:00Z","last_updated_date":"2011-06-20T04:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/696305/2010","document_url":"https://www.ema.europa.eu/en/documents/other/draft-questions-and-answers-template-qualified-persons-qps-declaration-concerning-good-manufacturing-practice-compliance-active-substance-used-starting-material-and-verification-its-supply_en.pdf"},
    {"id":"10899","name":"Call for scientific data for use in HMPC assessment work on Saccharomyces cerevisiae/Saccharomyces boulardii","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-14T18:50:00Z","last_updated_date":"2014-02-14T18:50:00Z","reference_number":"EMA/HMPC/87634/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-saccharomyces-cerevisiae-saccharomyces-boulardii_en.pdf"},
    {"id":"10976","name":"Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"2012-06-27 - 2012-08-24","first_published_date":"2012-12-13T18:00:00Z","last_updated_date":"2012-12-13T18:00:00Z","reference_number":"EMA/119871/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-iii-pharmacovigilance-inspections-superseded_en.pdf"},
    {"id":"11013","name":"Concept paper on the revision of annex 1 of the guidelines on good manufacturing practice – manufacture of sterile medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-02-05 - 2015-03-31","first_published_date":"2015-02-05T17:00:00Z","last_updated_date":"2015-02-05T17:00:00Z","reference_number":"EMA/INS/GMP/735037/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-annex-1-guidelines-good-manufacturing-practice-manufacture-sterile-medicinal-products_en.pdf"},
    {"id":"11069","name":"Draft European Union herbal monograph on Melilotus officinalis (L.) Lam., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-04-12 - 2017-07-16","first_published_date":"2017-04-12T17:13:00Z","last_updated_date":"2017-04-12T17:13:00Z","reference_number":"EMA/HMPC/44166/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-melilotus-officinalis-l-lam-herba_en.pdf"},
    {"id":"11161","name":"Draft list of references supporting the assessment of Echinacea purpurea (L.) Moench, radix","type":"herbal-references","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:00:00Z","last_updated_date":"2016-12-15T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-echinacea-purpurea-l-moench-radix_en.pdf"},
    {"id":"11235","name":"Draft community herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-02-11T02:00:00Z","last_updated_date":"2011-02-11T02:00:00Z","reference_number":"EMA/HMPC/563408/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-agropyron-repens-l-p-beauv-rhizoma_en.pdf"},
    {"id":"11246","name":"Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-01 - 2016-12-31","first_published_date":"2016-07-01T19:00:00Z","last_updated_date":"2016-07-01T19:00:00Z","reference_number":"EMA/CHMP/BWP/534898/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials-revision-1_en.pdf"},
    {"id":"11311","name":"Concept paper on use of recovered / recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products / traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-03-01T12:00:00Z","last_updated_date":"2013-03-01T12:00:00Z","reference_number":"EMA/HMPC/13658/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-use-recovered-recycled-solvents-manufacture-herbal-preparations-use-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"11328","name":"Draft VICH GL 18 residual solvents in new veterinary medicinal products, active substances and excipients  - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-10-31","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/CVMP/VICH/502/1999-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl-18-residual-solvents-new-veterinary-medicinal-products-active-substances-and-excipients-revision-1_en.pdf"},
    {"id":"11332","name":"Call for scientific data for use in HMPC assessment work on Origani majoranae herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-17T12:00:00Z","last_updated_date":"2014-02-17T12:00:00Z","reference_number":"EMA/HMPC/87625/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-origani-majoranae-herba_en.pdf"},
    {"id":"11354","name":"Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-29 - 2018-08-21","first_published_date":"2018-06-29T15:00:00Z","last_updated_date":"2018-06-29T15:00:00Z","reference_number":"EMA/CHMP/SAWP/423488/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-cellular-therapy-module-european-society-blood-marrow-transplantation-ebmt-registry_en.pdf"},
    {"id":"11363","name":"Draft European Union herbal monograph on Althaea officinalis L., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-12-11 - 2016-03-15","first_published_date":"2015-12-11T19:20:00Z","last_updated_date":"2015-12-11T19:20:00Z","reference_number":"EMA/HMPC/436679/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-althaea-officinalis-l-radix_en.pdf"},
    {"id":"11462","name":"Guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals)","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-01-10 - 2012-07-31","first_published_date":"2012-01-23T11:44:00Z","last_updated_date":"2012-01-23T11:44:00Z","reference_number":"EMA/CVMP/EWP/81976/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-statistical-principles-clinical-trials-veterinary-medicinal-products-pharmaceuticals_en.pdf"},
    {"id":"11485","name":"Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage form","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-17 - 2015-10-17","first_published_date":"2015-07-17T18:38:00Z","last_updated_date":"2015-07-17T18:38:00Z","reference_number":"EMA/CVMP/QWP/360463/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-manufacture-finished-dosage-form_en.pdf"},
    {"id":"11578","name":"Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-12-19 - 2015-03-31","first_published_date":"2014-12-19T15:45:00Z","last_updated_date":"2014-12-19T15:45:00Z","reference_number":"EMA/CVMP/IWP/37620/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-replacement-cell-lines-used-production-immunological-veterinary-medicinal-products-ivmps_en.pdf"},
    {"id":"11582","name":"Draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-07 - 2018-08-15","first_published_date":"2018-02-07T13:30:00Z","last_updated_date":"2018-02-07T13:30:00Z","reference_number":"CPMP/EWP/1080/00 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-or-prevention-diabetes-mellitus-revision-2_en.pdf"},
    {"id":"11586","name":"Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs for treatment of rheumatoid arthritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-05 - 2012-06-05","first_published_date":"2011-12-20T13:45:00Z","last_updated_date":"2011-12-20T13:45:00Z","reference_number":"CPMP/EWP/556/95 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-other-non-steroidal-anti-inflammatory-drugs-treatment-rheumatoid-arthritis_en.pdf"},
    {"id":"11612","name":"Draft assessment report on Olea europaea L., folium","type":"herbal-report","status":"Draft","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-07-14T04:00:00Z","last_updated_date":"2011-07-14T04:00:00Z","reference_number":"EMA/HMPC/430506/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-olea-europaea-l-folium_en.pdf"},
    {"id":"11666","name":"Draft questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-01 - 2018-07-31","first_published_date":"2018-02-01T11:20:00Z","last_updated_date":"2018-02-01T11:20:00Z","reference_number":"EMA/CHMP/BWP/192228/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-bovine-spongiform-encephalopathies-bse-and-vaccines-revision-1_en.pdf"},
    {"id":"11687","name":"Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-12-15 - 2015-06-30","first_published_date":"2014-12-15T18:00:00Z","last_updated_date":"2014-12-15T18:00:00Z","reference_number":"EMA/629967/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-minimal-residue-disease-endpoint-chronic-lymphocytic-leukaemia-studies_en.pdf"},
    {"id":"11688","name":"Call for scientific data for the systematic review of the monograph on Aesculus hippocastanum L., semen","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669362/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-aesculus-hippocastanum-l-semen_en.pdf"},
    {"id":"11724","name":"Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-09-15 - 2014-02-28","first_published_date":"2013-09-16T13:21:00Z","last_updated_date":"2013-09-16T13:21:00Z","reference_number":"EMA/CHMP/SWP/620008/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-data-requirements-intravenous-iron-based-nano-colloidal-products-developed-reference-innovator-medicinal-product_en.pdf"},
    {"id":"11727","name":"Call for scientific data for use in HMPC assessment work on Allium sativum L., bulbus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-06-01 - 2011-09-15","first_published_date":"2011-06-07T04:00:00Z","last_updated_date":"2011-06-07T04:00:00Z","reference_number":"EMA/HMPC/261528/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-allium-sativum-l-bulbus_en.pdf"},
    {"id":"11779","name":"Draft guideline on clinical investigation of medicinal products other than non-steroidal anti-inflammatory drugs (NSAIDs) for treatment of rheumatoid arthritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-04 - 2015-11-29","first_published_date":"2015-06-04T19:30:00Z","last_updated_date":"2015-06-04T19:30:00Z","reference_number":"CPMP/EWP/556/95 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-other-non-steroidal-anti-inflammatory-drugs-nsaids-treatment-rheumatoid-arthritis_en.pdf"},
    {"id":"11790","name":"Guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation","type":"scientific-guideline","status":"Adopted","consultation_date":"2014-07-15 - 2014-10-15","first_published_date":"2014-07-16T19:10:00Z","last_updated_date":"2014-07-16T19:10:00Z","reference_number":"EMA/CHMP/341363/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-prevention-stroke-and-systemic-embolic-events-patients-non-valvular-atrial-fibrillation_en.pdf"},
    {"id":"11980","name":"Concept paper on the need for a paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of acute heart failure","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-15 - 2013-04-15","first_published_date":"2013-01-16T12:00:00Z","last_updated_date":"2013-01-16T12:00:00Z","reference_number":"EMA/CHMP/778582/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure_en.pdf"},
    {"id":"12021","name":"Draft guideline on good pharmacovigilance practices: Module VII - Periodic safety update report","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/816292/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-vii-periodic-safety-update-report_en.pdf"},
    {"id":"12033","name":"Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-01 - 2014-12-31","first_published_date":"2014-10-01T18:00:00Z","last_updated_date":"2014-10-01T18:00:00Z","reference_number":"EMA/CHMP/328077/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-guideline-development-new-medicinal-products-treatment-crohns-disease_en.pdf"},
    {"id":"12076","name":"Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (E...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-10 - 2017-10-10","first_published_date":"2017-07-07T19:00:00Z","last_updated_date":"2017-07-07T19:00:00Z","reference_number":"EMA/CHMP/644998/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-addendum-terms-and-concepts-pharmacogenomic-features-related-metabolism-guideline-use-pharmacogenetic-methodologies-pharmacokinetic-evaluation-medicinal-products-e_en.pdf"},
    {"id":"12134","name":"Draft guideline on the clinical  investigation of medicines for the treatment of Alzheimer’s disease and other dementias","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-01 - 2016-07-31","first_published_date":"2016-02-01T16:30:00Z","last_updated_date":"2016-02-01T16:30:00Z","reference_number":"EMA/CHMP/539931/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicines-treatment-alzheimers-disease-and-other-dementias_en.pdf"},
    {"id":"12146","name":"Call for scientific data for the systematic review of the monograph on Commiphora molmol Engler, gummi-resina","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-07-15 - 2016-10-15","first_published_date":"2016-07-15T13:00:00Z","last_updated_date":"2016-07-15T13:00:00Z","reference_number":"EMA/HMPC/403788/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"12162","name":"Stem cell-based products for veterinary use: specific questions on sterility to be addressed by ADVENT - draft","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-03-04 - 2016-05-15","first_published_date":"2016-03-04T12:00:00Z","last_updated_date":"2016-03-04T12:00:00Z","reference_number":"EMA/CVMP/ADVENT/226871/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/stem-cell-based-products-veterinary-use-specific-questions-sterility-be-addressed-advent-draft_en.pdf"},
    {"id":"12270","name":"Questions and answers on Benzoic acid and Benzoates in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-24 - 2014-05-31","first_published_date":"2014-02-24T12:00:00Z","last_updated_date":"2014-02-24T12:00:00Z","reference_number":"EMA/CHMP/508189/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-benzoic-acid-and-benzoates-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"12401","name":"Draft list of references supporting the assessment of Trigonella foenum-graecum L., semen","type":"herbal-references","status":"Draft","consultation_date":"2010-05-15 - 2010-09-15","first_published_date":"2010-06-10T04:00:00Z","last_updated_date":"2010-06-10T04:00:00Z","reference_number":"EMA/HMPC/574496/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-trigonella-foenum-graecum-l-semen_en.pdf"},
    {"id":"12500","name":"Call for scientific data for the systematic review of the monograph on Eleutherococcus senticosus (Rupr. et Maxim.) Maxim., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91102/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-eleutherococcus-senticosus-rupr-et-maxim-maxim-radix_en.pdf"},
    {"id":"12540","name":"Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-27 - 2018-12-31","first_published_date":"2018-07-27T20:10:00Z","last_updated_date":"2018-07-27T20:10:00Z","reference_number":"EMA/CVMP/VICH/335918/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl58-stability-testing-new-veterinary-drug-substances-and-medicinal-products-climatic-zones-iii-and-iv-first-version_en.pdf"},
    {"id":"12614","name":"Draft guideline on similar biological medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-05-02 - 2013-10-31","first_published_date":"2013-05-02T15:10:00Z","last_updated_date":"2013-05-02T15:10:00Z","reference_number":"CHMP/437/04 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-biological-medicinal-products_en.pdf"},
    {"id":"12620","name":"Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-04-09 - 2014-07-09","first_published_date":"2014-04-09T20:30:00Z","last_updated_date":"2014-04-09T20:30:00Z","reference_number":"EMA/CHMP/CVMP/QWP/128000/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-establishment-guideline-selection-sterilisation-processes-drug-products_en.pdf"},
    {"id":"12630","name":"Draft questions and answers on boric acid in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-08-04 - 2015-11-03","first_published_date":"2015-08-04T12:30:00Z","last_updated_date":"2015-08-04T12:30:00Z","reference_number":"EMA/CHMP/619104/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-boric-acid-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"12717","name":"Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-08 - 2016-10-14","first_published_date":"2016-08-08T19:00:00Z","last_updated_date":"2016-08-08T19:00:00Z","reference_number":"EMA/827661/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-ix-signal-management-rev-1_en.pdf"},
    {"id":"12729","name":"Call for scientific data for the systematic review of the monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-07-15 - 2016-10-15","first_published_date":"2016-07-15T13:00:00Z","last_updated_date":"2016-07-15T13:00:00Z","reference_number":"EMA/HMPC/403789/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-first-version_en.pdf"},
    {"id":"12757","name":"Draft guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-01 - 2015-07-01","first_published_date":"2015-06-01T19:00:00Z","last_updated_date":"2015-06-01T19:00:00Z","reference_number":"EMA/CHMP/BPWP/144533/2009 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-viii-products-revision-1_en.pdf"},
    {"id":"12774","name":"Draft public statement on Andrographis paniculata Nees, folium - First version","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2013-01-15 - 2013-04-15","first_published_date":"2013-01-25T02:00:00Z","last_updated_date":"2013-01-25T02:00:00Z","reference_number":"EMA/HMPC/709282/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-andrographis-paniculata-nees-folium-first-version_en.pdf"},
    {"id":"12849","name":"Draft European Union herbal monograph on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-02-10 - 2015-05-15","first_published_date":"2011-02-11T02:00:00Z","last_updated_date":"2015-02-10T15:40:00Z","reference_number":"EMA/HMPC/84990/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"12855","name":"Draft guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-08-01 - 2014-01-31","first_published_date":"2013-08-01T20:30:00Z","last_updated_date":"2013-08-01T20:30:00Z","reference_number":"EMA/CHMP/40105/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"12922","name":"Call for scientific data for the systematic review of the monograph on Salix (various species including S. purpurea L., S. daphnoides Vill., S. fragilis L.), whole or fragmented dried bark","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-05-28 - 2015-08-31","first_published_date":"2015-05-28T13:20:00Z","last_updated_date":"2015-05-28T13:20:00Z","reference_number":"EMA/HMPC/343246/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-salix-various-species-including-s-purpurea-l-s-daphnoides-vill-s-fragilis-l-whole-or-fragmented-dried-bark_en.pdf"},
    {"id":"12976","name":"Draft guideline on repeated dose toxicity","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2008-02-21 - 2008-05-30","first_published_date":"2008-02-21T02:00:00Z","last_updated_date":"2008-02-21T02:00:00Z","reference_number":"EMEA/CHMP/SWP/488313/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-repeated-dose-toxicity_en.pdf"},
    {"id":"13021","name":"Draft guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-03 - 2016-07-31","first_published_date":"2016-02-03T13:00:00Z","last_updated_date":"2016-02-03T13:00:00Z","reference_number":"EMA/CVMP/EWP/117899/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-efficacy-and-target-animal-safety-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market-revision-1_en.pdf"},
    {"id":"13023","name":"Call for scientific data for the periodic review of the monograph on Capsella bursa-pastoris (L.) Medikus, herba - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/248382/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-capsella-bursa-pastoris-l-medikus-herba-first-version_en.pdf"},
    {"id":"13087","name":"Draft guideline on the compliance of authorised equine influenza vaccines with World Organisation for Animal Health requirements","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-11 - 2013-04-30","first_published_date":"2013-04-25T15:30:00Z","last_updated_date":"2013-04-25T15:30:00Z","reference_number":"EMA/CVMP/IWP/97961/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-compliance-authorised-equine-influenza-vaccines-world-organisation-animal-health-requirements_en.pdf"},
    {"id":"13093","name":"Call for scientific data for the systematic review of the monograph on Humulus lupulus L., flos - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91099/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-humulus-lupulus-l-flos-revision-1_en.pdf"},
    {"id":"13165","name":"Draft reflection paper on use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-25 - 2017-10-31","first_published_date":"2017-07-25T20:35:00Z","last_updated_date":"2017-07-25T20:35:00Z","reference_number":"EMA/CVMP/AWP/721118/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-aminoglycosides-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"13202","name":"Draft monoclonal antibodies for veterinary use: specific questions to be addressed by ADVENT","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-03-04 - 2016-05-15","first_published_date":"2016-03-04T12:00:00Z","last_updated_date":"2016-03-04T12:00:00Z","reference_number":"EMA/CVMP/ADVENT/276476/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-monoclonal-antibodies-veterinary-use-specific-questions-be-addressed-advent_en.pdf"},
    {"id":"13214","name":"Call for scientific data for use in HMPC assessment work on Malva sylvestris L., folium and flos - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669364/2015 Corr","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-malva-sylvestris-l-folium-and-flos-first-version_en.pdf-0"},
    {"id":"13235","name":"Draft questions and answers on Data Monitoring Committees issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-08-01 - 2019-07-31","first_published_date":"2018-08-01T21:00:00Z","last_updated_date":"2018-08-01T21:00:00Z","reference_number":"EMA/492010/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-data-monitoring-committees-issues_en.pdf"},
    {"id":"13269","name":"Draft assessment report on Trigonella foenum-graecum L., semen","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-09-15","first_published_date":"2010-06-10T04:00:00Z","last_updated_date":"2010-06-10T04:00:00Z","reference_number":"EMA/HMPC/146220/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-trigonella-foenum-graecum-l-semen_en.pdf"},
    {"id":"13319","name":"Draft reflection paper on in vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2007-12-13 - 2008-06-30","first_published_date":"2007-12-13T02:00:00Z","last_updated_date":"2007-12-13T02:00:00Z","reference_number":"EMEA/CHMP/SWP/8212/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-vitro-investigation-mitochondrial-toxicity-anti-hiv-nucleoside-reverse-transcriptase-inhibitors_en.pdf"},
    {"id":"13446","name":"Draft joint Ministry of Health, Labour and Welfare / European Medicines Agency reflection paper on the development of block-copolymer-micelle medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-02-01 - 2013-07-01","first_published_date":"2013-02-01T17:00:00Z","last_updated_date":"2013-02-01T17:00:00Z","reference_number":"EMA/CHMP/13099/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-joint-ministry-health-labour-and-welfare-european-medicines-agency-reflection-paper-development-block-copolymer-micelle-medicinal-products_en.pdf"},
    {"id":"13459","name":"Draft guideline on evaluation of anticancer medicinal products in man - Revision 5","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-03-15 - 2016-09-15","first_published_date":"2016-03-15T15:20:00Z","last_updated_date":"2016-03-15T15:20:00Z","reference_number":"EMA/CHMP/205/95 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-anticancer-medicinal-products-man-revision-5_en.pdf"},
    {"id":"13612","name":"Draft elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil film-coated tablets 150 mg/150 mg/200 mg/ 245 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-22 - 2017-03-31","first_published_date":"2016-12-22T14:00:00Z","last_updated_date":"2016-12-22T14:00:00Z","reference_number":"EMA/CHMP/805518/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-film-coated-tablets-150-mg-150-mg-200-mg-245-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"13643","name":"Draft procedure for the review and revision of European Union  herbal monographs and European Union list entries","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-27 - 2018-01-28","first_published_date":"2017-10-27T20:00:00Z","last_updated_date":"2017-10-31T18:00:00Z","reference_number":"EMA/HMPC/124695/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-procedure-review-and-revision-european-union-herbal-monographs-and-european-union-list-entries_en.pdf"},
    {"id":"13653","name":"Concept paper on the need to develop an appendix to the guideline on bioequivalence regarding the presentation of biopharmaceutical and bioanalytical data in application dossiers","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-07-31","first_published_date":"2010-04-30T04:00:00Z","last_updated_date":"2010-04-30T04:00:00Z","reference_number":"EMA/CHMP/EWP/82259/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-develop-appendix-guideline-bioequivalence-regarding-presentation-biopharmaceutical-and-bioanalytical-data-application-dossiers_en.pdf"},
    {"id":"13658","name":"Draft Community herbal monograph on Phaseolus vulgaris L., fructus sine semine","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-03-12 - 2013-07-15","first_published_date":"2013-05-14T04:00:00Z","last_updated_date":"2013-05-14T04:00:00Z","reference_number":"EMA/HMPC/317319/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-phaseolus-vulgaris-l-fructus-sine-semine_en.pdf"},
    {"id":"13706","name":"Draft inventory of paediatric therapeutic needs - Endocrinology","type":"other","status":"Draft: consultation closed","consultation_date":"2015-05-08 - 2015-07-06","first_published_date":"2015-05-11T18:05:00Z","last_updated_date":"2015-06-01T18:05:00Z","reference_number":"EMA/PDCO/52553/2015 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-therapeutic-needs-endocrinology_en.pdf"},
    {"id":"13718","name":"Draft European Union herbal monograph on Species diureticae","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2016-10-28 - 2017-01-28","first_published_date":"2016-10-28T04:00:00Z","last_updated_date":"2016-10-28T04:00:00Z","reference_number":"EMA/HMPC/224755/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-species-diureticae_en.pdf"},
    {"id":"13773","name":"Draft miglustat product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/422796/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-miglustat-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"13834","name":"Draft guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-12 - 2016-10-12","first_published_date":"2016-04-12T12:50:00Z","last_updated_date":"2016-04-12T12:50:00Z","reference_number":"EMA/CHMP/QWP/834816/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-clinical-trials-revision-1_en.pdf"},
    {"id":"13953","name":"Draft reflection paper on the use of cocrystals and other solid-state forms of active substances in medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-31 - 2014-10-31","first_published_date":"2014-07-31T19:00:00Z","last_updated_date":"2014-07-31T19:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/136250/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-cocrystals-and-other-solid-state-forms-active-substances-medicinal-products_en.pdf"},
    {"id":"13974","name":"Concept paper on the need for revision of the note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-08-31","first_published_date":"2010-06-08T04:00:00Z","last_updated_date":"2010-06-08T04:00:00Z","reference_number":"EMA/CHMP/1303/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-modified-release-oral-and-transdermal-dosage-forms-section-ii-pharmacokinetic-and-clinical-evaluation_en.pdf"},
    {"id":"14058","name":"Concept paper on the need for a reflection paper on quality aspects of medicines for older people - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-05 - 2013-06-30","first_published_date":"2013-04-05T15:00:00Z","last_updated_date":"2013-04-05T15:00:00Z","reference_number":"EMA/165974/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-reflection-paper-quality-aspects-medicines-older-people-first-version_en.pdf"},
    {"id":"14107","name":"Draft European Union list entry on Sideritis scardica Griseb., herba","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2015-07-27 - 2015-10-31","first_published_date":"2015-07-27T15:00:00Z","last_updated_date":"2015-07-27T15:00:00Z","reference_number":"EMA/HMPC/150543/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-european-union-list-entry-sideritis-scardica-griseb-herba_en.pdf"},
    {"id":"14191","name":"Call for scientific data for use in HMPC assessment work on Herniariae glabra L.; Herniariae hirsuta L.; Herniariae incana LAM., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/1887935/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-herniariae-glabra-l-herniariae-hirsuta-l-herniariae-incana-lam-herba_en.pdf"},
    {"id":"14196","name":"Draft dasatinib product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423718/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dasatinib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"14243","name":"Diflubenzuron: Call for scientific data for use in CVMP assessment work of diflubenzuron: review of the CVMP opinion for the establishment of maximum residue limits","type":"mrl-report","status":"Draft: consultation closed","consultation_date":"2014-06-10 - 2014-09-30","first_published_date":"2014-06-10T20:25:00Z","last_updated_date":"2014-06-10T20:25:00Z","reference_number":"EMA/CVMP/337469/2014","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diflubenzuron-call-scientific-data-use-cvmp-assessment-work-diflubenzuron-review-cvmp-opinion-establishment-maximum-residue-limits_en.pdf"},
    {"id":"14256","name":"Draft reflection paper on classification of advanced-therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-06-30 - 2014-10-31","first_published_date":"2014-06-30T16:30:00Z","last_updated_date":"2014-06-30T16:30:00Z","reference_number":"EMA/CAT/600280/2010 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-classification-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"14324","name":"Draft guideline on good pharmacovigilance practices: Module V - Risk management systems","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/838713/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-v-risk-management-systems_en.pdf"},
    {"id":"14369","name":"Draft community herbal monograph on Juniperus communis L., aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-08-15","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/HMPC/12402/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-juniperus-communis-l-aetheroleum_en.pdf"},
    {"id":"14370","name":"Draft information in the package leaflet for aspartame in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-04 - 2016-08-03","first_published_date":"2016-05-04T17:00:00Z","last_updated_date":"2016-05-04T17:00:00Z","reference_number":"EMA/CHMP/134648/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-aspartame-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-cpmp-463-00-rev-1_en.pdf"},
    {"id":"14411","name":"Draft VICH GL34: Biologicals: testing for the detection of mycoplasma contamination","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-08 - 2012-03-12","first_published_date":"2011-12-20T16:15:00Z","last_updated_date":"2011-12-20T16:15:00Z","reference_number":"EMA/CVMP/VICH/463/2002","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl34-biologicals-testing-detection-mycoplasma-contamination_en.pdf"},
    {"id":"14414","name":"Draft Community herbal monograph on Capsicum annuum L.\n\nvar. minimum (Miller) Heiser and small fruited varieties of\n\nCapsicum frutescens L., fructus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-09-12 - 2014-12-15","first_published_date":"2014-09-12T04:00:00Z","last_updated_date":"2014-09-12T04:00:00Z","reference_number":"EMA/HMPC/674139/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-capsicum-annuum-l-var-minimum-miller-heiser-and-small-fruited-varieties-capsicum-frutescens-l-fructus_en.pdf"},
    {"id":"14440","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-06-23 - 2011-09-30","first_published_date":"2011-07-01T04:00:00Z","last_updated_date":"2011-07-01T04:00:00Z","reference_number":"EMA/CHMP/114599/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-prophylaxis-high-intra-and-post-operative-venous-thromboembolic-risk_en.pdf"},
    {"id":"14472","name":"Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-24 - 2015-07-24","first_published_date":"2015-04-24T18:30:00Z","last_updated_date":"2015-04-24T18:30:00Z","reference_number":"EMA/CHMP/QWP/104223/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-chemical-structure-and-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances_en.pdf"},
    {"id":"14510","name":"Draft guideline on statistical principles for veterinary clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-15 - 2011-03-31","first_published_date":"2010-09-27T04:00:00Z","last_updated_date":"2010-09-27T04:00:00Z","reference_number":"EMA/CVMP/EWP/81976/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-statistical-principles-veterinary-clinical-trials_en.pdf"},
    {"id":"14560","name":"Reflection paper on anthelmintic resistance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-29 - 2016-07-31","first_published_date":"2016-04-29T18:25:00Z","last_updated_date":"2016-04-29T18:25:00Z","reference_number":"CVMP/EWP/573536/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-anthelmintic-resistance_en.pdf-0"},
    {"id":"14609","name":"Draft appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-17 - 2011-05-31","first_published_date":"2011-03-14T02:00:00Z","last_updated_date":"2011-03-14T02:00:00Z","reference_number":"EMA/CHMP/600958/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-appendix-iv-guideline-investigation-bioequivalence-cpmp-ewp-qwp-1401-98-rev1-presentation-biopharmaceutical-and-bioanalytical-data-module-271_en.pdf"},
    {"id":"14617","name":"Draft European Union herbal monograph on Gentiana lutea L., radix – Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2018-04-11 - 2018-07-15","first_published_date":"2018-04-11T04:00:00Z","last_updated_date":"2018-04-11T04:00:00Z","reference_number":"EMA/607861/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-gentiana-lutea-l-radix-revision-1_en.pdf"},
    {"id":"14635","name":"Draft reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-11-18 - 2017-05-31","first_published_date":"2016-11-18T10:31:00Z","last_updated_date":"2016-11-18T10:31:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/742466/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-providing-overview-current-regulatory-testing-requirements-medicinal-products-human-use-and-opportunities-implementation-3rs-first-version_en.pdf"},
    {"id":"14684","name":"Call for scientific data for the systematic review of the monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91105/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-foeniculum-vulgare-miller-subsp-vulgare-var-dulce-miller-thellung-fructus_en.pdf"},
    {"id":"14703","name":"Second draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-27 - 2018-10-31","first_published_date":"2018-07-27T16:46:00Z","last_updated_date":"2018-07-27T16:46:00Z","reference_number":"EMA/CVMP/AWP/706442/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/second-draft-guideline-assessment-risk-public-health-antimicrobial-resistance-due-use-antimicrobial-veterinary-medicinal-product-food-producing-animals_en.pdf"},
    {"id":"14826","name":"Concept paper introducing a review and update of existing European Union guidelines on residues studies to bring these into line with the International Cooperation on Harmonisation of Technical Requirements for Registrat...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-15 - 2012-05-31","first_published_date":"2012-02-15T11:00:00Z","last_updated_date":"2012-02-15T11:00:00Z","reference_number":"EMA/CVMP/SWP/878228/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-introducing-review-and-update-existing-european-union-guidelines-residues-studies-bring-these-line-international-cooperation-harmonisation-technical-requirements-registrat_en.pdf"},
    {"id":"14835","name":"Draft Crizotinib hard capsules 200 mg and 250 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-22 - 2017-03-31","first_published_date":"2016-12-22T14:00:00Z","last_updated_date":"2016-12-22T14:00:00Z","reference_number":"EMA/CHMP/805479/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-crizotinib-hard-capsules-200-mg-and-250-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"14836","name":"Draft guideline on the need for non-clinical testing in juvenile animals of pharmaceuticals for paediatric indications","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2005-10-11 - 2006-04-30","first_published_date":"2005-09-29T04:00:00Z","last_updated_date":"2005-09-29T04:00:00Z","reference_number":"EMEA/CHMP/SWP/169215/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-need-non-clinical-testing-juvenile-animals-pharmaceuticals-paediatric-indications_en.pdf"},
    {"id":"14914","name":"Draft concept paper on requirements for the production and control of allergen products for use in animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-09-18 - 2015-12-31","first_published_date":"2015-09-18T12:46:00Z","last_updated_date":"2015-09-18T12:46:00Z","reference_number":"EMA/CVMP/IWP/351882/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-requirements-production-and-control-allergen-products-use-animals_en.pdf"},
    {"id":"15006","name":"Draft European Union herbal monograph on Malva sylvestris L., flos - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2018-06-30 - 2018-09-15","first_published_date":"2018-07-02T04:00:00Z","last_updated_date":"2018-07-02T04:00:00Z","reference_number":"EMA/HMPC/749511/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-malva-sylvestris-l-flos-first-version_en.pdf"},
    {"id":"15036","name":"Call for scientific data for the systematic review of the monograph on Plantago ovata Forssk., semen","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558983/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-plantago-ovata-forssk-semen_en.pdf"},
    {"id":"15065","name":"Draft reflection paper on the use of extrapolation in the development of medicines for paediatrics - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-13 - 2018-01-14","first_published_date":"2017-10-13T14:34:00Z","last_updated_date":"2017-10-13T14:34:00Z","reference_number":"EMA/199678/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-extrapolation-development-medicines-paediatrics-revision-1_en.pdf"},
    {"id":"15106","name":"Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-03 - 2017-10-31","first_published_date":"2017-08-03T20:35:00Z","last_updated_date":"2017-08-03T20:35:00Z","reference_number":"EMA/CHMP/158772/2016/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-prasugrel-hydrochloride-film-coated-tablets-5-mg-and-10-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"15175","name":"Concept paper on the need for revision of the guideline on the clinical development of medicinal products for the treatment of Hepatitis C","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-07-31","first_published_date":"2010-04-30T04:00:00Z","last_updated_date":"2010-04-30T04:00:00Z","reference_number":"EMA/CHMP/EWP/825749/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-development-medicinal-products-treatment-hepatitis-c_en.pdf"},
    {"id":"15223","name":"Call for scientific data for the systematic review of the monograph on Echinacea purpurea (L.) Moench, radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669361/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-echinacea-purpurea-l-moench-radix_en.pdf"},
    {"id":"15248","name":"Draft assessment report on Vitis vinifera L., folium","type":"herbal-report","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:54:00Z","last_updated_date":"2016-12-15T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-vitis-vinifera-l-folium_en.pdf"},
    {"id":"15319","name":"Draft guideline on pharmaceutical development of medicines for paediatric use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-04 - 2013-03-31","first_published_date":"2013-01-04T13:21:00Z","last_updated_date":"2013-01-04T13:21:00Z","reference_number":"EMA/CHMP/QWP/805880/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf"},
    {"id":"15373","name":"Draft European Union herbal monograph on Vaccinium myrtillus L., fructus recens","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-02-09 - 2015-05-15","first_published_date":"2015-02-09T12:30:00Z","last_updated_date":"2015-02-09T12:30:00Z","reference_number":"EMA/HMPC/375808/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-vaccinium-myrtillus-l-fructus-recens_en.pdf"},
    {"id":"15381","name":"Draft list of references supporting the assessment of Achillea millefolium L., herba","type":"herbal-references","status":"Draft","consultation_date":"2010-11-15 - 2011-02-15","first_published_date":"2010-11-09T02:00:00Z","last_updated_date":"2010-11-09T02:00:00Z","reference_number":"EMA/HMPC/290282/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-achillea-millefolium-l-herba_en.pdf"},
    {"id":"15401","name":"Draft Community herbal monograph on Marrubium vulgare L., herba - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-01-15 - 2013-04-15","first_published_date":"2013-01-28T02:00:00Z","last_updated_date":"2013-01-28T02:00:00Z","reference_number":"EMA/HMPC/604271/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-marrubium-vulgare-l-herba-first-version_en.pdf"},
    {"id":"15414","name":"Call for scientific data for use in HMPC assessment work on Polygoni avicularis herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-03-15 - 2014-06-15","first_published_date":"2014-03-14T18:15:00Z","last_updated_date":"2014-03-14T18:15:00Z","reference_number":"EMA/HMPC/143245/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-polygoni-avicularis-herba_en.pdf"},
    {"id":"15443","name":"Call for scientific data for use in HMPC assessment work on Panax ginseng C.A. Meyer, radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-07-15","first_published_date":"2011-04-14T04:00:00Z","last_updated_date":"2011-04-14T04:00:00Z","reference_number":"EMA/HMPC/278493/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-panax-ginseng-ca-meyer-radix_en.pdf"},
    {"id":"15491","name":"Draft Community herbal monograph on Cetraria islandica (L.) Acharius s.l., thallus - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-05-19 - 2014-08-31","first_published_date":"2014-05-19T20:45:00Z","last_updated_date":"2014-05-19T20:45:00Z","reference_number":"EMA/HMPC/678891/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cetraria-islandica-l-acharius-sl-thallus-first-version_en.pdf"},
    {"id":"15618","name":"Call for scientific data for the review of the HMPC assessment on Withania somnifera (L.) Dunal, radix - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/250486/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-review-hmpc-assessment-withania-somnifera-l-dunal-radix-first-version_en.pdf"},
    {"id":"15623","name":"Draft concept paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-05-02 - 2014-07-31","first_published_date":"2014-05-02T15:40:00Z","last_updated_date":"2014-05-02T15:40:00Z","reference_number":"EMA/CHMP/BWP/78086/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-viral-safety-plasma-derived-medicinal-products-respect-hepatitis-e-virus_en.pdf"},
    {"id":"15632","name":"Draft addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-07-04 - 2013-01-31","first_published_date":"2012-07-04T19:25:47Z","last_updated_date":"2012-07-04T19:25:47Z","reference_number":"EMA/CHMP/776609/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-cpmp-ewp-558-95-rev-2-address-indication-specific-clinical-data_en.pdf"},
    {"id":"15667","name":"Draft procedure on the publication of HMPC public statements when Community herbal monographs on herbal substances, preparations and/or combinations thereof are not established","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-05-15","first_published_date":"2011-02-16T02:00:00Z","last_updated_date":"2011-02-16T02:00:00Z","reference_number":"EMA/HMPC/84530/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-procedure-publication-hmpc-public-statements-when-community-herbal-monographs-herbal-substances-preparations-and-or-combinations-thereof-are-not-established_en.pdf"},
    {"id":"15693","name":"Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-28 - 2014-05-31","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"EMA/CHMP/792679/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-points-consider-pharmacokinetics-and-pharmacodynamics-development-antibacterial-medicinal-products-chmp-ewp-2655-99-and-conversion-chmp-guideline_en.pdf"},
    {"id":"15718","name":"ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-08-06 - 2019-02-06","first_published_date":"2018-08-06T18:30:00Z","last_updated_date":"2018-08-06T18:30:00Z","reference_number":"EMA/CHMP/ICH/493213/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m9-biopharmaceutics-classification-system-based-biowaivers-step-2b-first-version_en.pdf"},
    {"id":"15733","name":"Qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for BMS-708163","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-10 - 2011-03-25","first_published_date":"2011-02-10T02:00:00Z","last_updated_date":"2011-02-10T02:00:00Z","reference_number":"EMA/CHMP/SAWP/102001/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-alzheimers-disease-novel-methodologies-biomarkers-bms-708163_en.pdf"},
    {"id":"15907","name":"Draft guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-08-11 - 2015-10-09","first_published_date":"2015-08-11T13:00:00Z","last_updated_date":"2015-08-11T13:00:00Z","reference_number":"EMA/813938/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-viii-post-authorisation-safety-studies-rev-2_en.pdf"},
    {"id":"15917","name":"Draft guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-15 - 2013-09-15","first_published_date":"2013-03-15T13:00:00Z","last_updated_date":"2013-03-15T13:00:00Z","reference_number":"EMA/CHMP/EWP/280/96 Rev1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-pharmacokinetic-and-clinical-evaluation-modified-release-dosage-forms_en.pdf"},
    {"id":"15978","name":"Draft guideline on manufacture of the veterinary finished dosage form","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-04-23 - 2019-08-31","first_published_date":"2018-04-23T13:22:00Z","last_updated_date":"2019-01-07T12:22:00Z","reference_number":"EMA/CVMP/QWP/798401/2015 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-manufacture-veterinary-finished-dosage-form_en.pdf"},
    {"id":"15982","name":"Draft guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)","type":"template-form","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-02-29","first_published_date":"2015-12-15T13:30:00Z","last_updated_date":"2015-12-15T13:30:00Z","reference_number":"EMA/334164/2015","document_url":"https://www.ema.europa.eu/en/documents/template-form/draft-guideline-good-pharmacovigilance-practices-gvp-annex-ii-templates-communication-plan-direct-healthcare-professional-communication-cp-dhpc_en.pdf"},
    {"id":"15986","name":"Draft concept paper on need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-10-31 - 2014-01-31","first_published_date":"2013-10-31T12:00:00Z","last_updated_date":"2013-10-31T12:00:00Z","reference_number":"EMA/CHMP/617734/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-guideline-medicinal-products-treatment-alzheimers-disease-and-other-dementias-revision-1_en.pdf"},
    {"id":"16019","name":"Draft posaconazole product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423719/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-posaconazole-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"16044","name":"Draft ICH guideline E2C (R2): Periodic benefit-risk evaluation report (PBRER)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2012-04-16 - 2012-05-21","first_published_date":"2012-04-16T21:38:33Z","last_updated_date":"2012-04-16T21:38:33Z","reference_number":"EMA/CHMP/ICH/544553/1998","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-ich-guideline-e2c-r2-periodic-benefit-risk-evaluation-report-pbrer_en.pdf"},
    {"id":"16105","name":"Call for scientific data for use in HMPC assessment work on Eucalyptus globulus Labill., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-06-07 - 2011-09-15","first_published_date":"2011-06-07T04:00:00Z","last_updated_date":"2011-06-07T04:00:00Z","reference_number":"EMA/HMPC/417632/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-eucalyptus-globulus-labill-folium_en.pdf"},
    {"id":"16114","name":"Draft guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-01 - 2016-12-31","first_published_date":"2016-07-01T13:30:00Z","last_updated_date":"2016-07-01T13:30:00Z","reference_number":"CPMP/EWP/4891/03","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-axial-spondyloarthritis-revision-1_en.pdf"},
    {"id":"16117","name":"ICH: Q 4 B Annex 11: Capillary electrophoresis general chapter: Annex 11 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on capillary electrophoresis general chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-11-01 - 2010-02-28","first_published_date":"2009-12-18T02:00:00Z","last_updated_date":"2009-12-18T02:00:00Z","reference_number":"EMEA/CHMP/ICH/730028/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-4-b-annex-11-capillary-electrophoresis-general-chapter-annex-11-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-capillary-electrophoresis-general-chapter-step-3_en.pdf"},
    {"id":"16165","name":"Draft tacrolimus granules for oral suspension 0.2 and 1 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-01 - 2016-01-01","first_published_date":"2015-10-06T17:00:00Z","last_updated_date":"2015-10-06T17:00:00Z","reference_number":"EMA/CHMP/PKWP/36648/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-tacrolimus-granules-oral-suspension-02-and-1-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"16236","name":"Draft guideline on approach towards harmonisation of withdrawal periods","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-25 - 2017-01-31","first_published_date":"2016-07-25T18:20:00Z","last_updated_date":"2016-07-25T18:20:00Z","reference_number":"EMA/CVMP/SWP/735325/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-approach-towards-harmonisation-withdrawal-periods_en.pdf"},
    {"id":"16252","name":"Call for scientific data for the periodic review of the monograph on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria L.), herba - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/252429/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-filipendula-ulmaria-l-maxim-spiraea-ulmaria-l-herba-first-version_en.pdf"},
    {"id":"16292","name":"Draft guideline on good pharmacovigilance practices: Module VI - Management and reporting of adverse reactions to medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/873138/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-vi-management-and-reporting-adverse-reactions-medicinal-products_en.pdf"},
    {"id":"16347","name":"ICH: M 3 (R2): Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2008-07-01 - 2008-10-01","first_published_date":"2008-07-01T04:00:00Z","last_updated_date":"2008-07-01T04:00:00Z","reference_number":"CPMP/ICH/286/95-draft","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m-3-r2-non-clinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorization-pharmaceuticals-step-3_en.pdf"},
    {"id":"16410","name":"Draft guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-08-11 - 2015-10-09","first_published_date":"2015-08-11T13:00:00Z","last_updated_date":"2015-08-11T13:00:00Z","reference_number":"EMA/395730/2012 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-viii-addendum-i-requirements-transmission-information-non-interventional-post-authorisation-safety-studies-rev-2_en.pdf"},
    {"id":"16431","name":"Draft Community herbal monograph on Commiphora molmol Engler, gummi-resina","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-09-01 - 2010-03-15","first_published_date":"2010-11-16T02:00:00Z","last_updated_date":"2010-11-16T02:00:00Z","reference_number":"EMA/HMPC/96911/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-commiphora-molmol-engler-gummi-resina_en.pdf"},
    {"id":"16478","name":"Draft inventory of paediatric therapeutic needs - Nephro-urology","type":"other","status":"Draft: consultation closed","consultation_date":"2013-08-12 - 2013-10-14","first_published_date":"2013-08-12T13:30:00Z","last_updated_date":"2013-08-12T13:30:00Z","reference_number":"EMA/PDCO/358806/2013","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-therapeutic-needs-nephro-urology_en.pdf"},
    {"id":"16490","name":"Draft aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-27 - 2018-09-30","first_published_date":"2018-06-27T14:30:00Z","last_updated_date":"2018-06-27T14:30:00Z","reference_number":"EMA/CHMP/291450/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-aliskiren-film-coated-tablet-150-mg-and-300-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"16496","name":"Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2019-08-31","first_published_date":"2018-04-30T15:33:00Z","last_updated_date":"2018-09-21T20:00:00Z","reference_number":"EMA/CVMP/383441/2005-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-summary-product-characteristics-spc-veterinary-medicinal-products-containing-antimicrobial-substances-revision-1_en.pdf"},
    {"id":"16544","name":"Draft qualification opinion of qualification of exacerbations of chronic pulmonary disease tool (EXACT), and EXACT-respiratory symptoms measure (E-RS) for evaluating treatment outcomes in clinical trials in chronic pulmo...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-13 - 2015-05-25","first_published_date":"2015-04-13T14:40:00Z","last_updated_date":"2015-04-13T14:40:00Z","reference_number":"EMA/CHMP/SAWP/178465/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-qualification-exacerbations-chronic-pulmonary-disease-tool-exact-and-exact-respiratory-symptoms-measure-e-rs-evaluating-treatment-outcomes-clinical-trials-chronic-pulmo_en.pdf"},
    {"id":"16576","name":"Draft community herbal monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-08-15","first_published_date":"2011-04-20T04:00:00Z","last_updated_date":"2011-04-20T04:00:00Z","reference_number":"EMA/HMPC/277792/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-first-version_en.pdf"},
    {"id":"16625","name":"Draft sunitinib product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-12-03 - 2014-03-03","first_published_date":"2013-12-04T12:05:00Z","last_updated_date":"2013-12-04T12:05:00Z","reference_number":"CHMP/PKWP/EMA/423716/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-sunitinib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"16665","name":"Draft zonisamide hard capsules 25, 50 and 100 mg, orodispersible tablets 25, 50, 100 and 300 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-15 - 2015-11-01","first_published_date":"2015-07-15T14:00:03Z","last_updated_date":"2015-07-15T14:00:03Z","reference_number":"EMA/CHMP/PKWP/253507/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-zonisamide-hard-capsules-25-50-and-100-mg-orodispersible-tablets-25-50-100-and-300-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"16736","name":"Call for scientific data for the systematic review of the monograph on Salvia officinalis L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-12-12 - 2015-03-15","first_published_date":"2014-12-15T13:40:00Z","last_updated_date":"2014-12-15T13:40:00Z","reference_number":"EMA/HMPC/776602/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-salvia-officinalis-l-folium_en.pdf"},
    {"id":"16795","name":"Draft concept paper for a guideline on the demonstration of palatability of veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-11-09 - 2011-02-28","first_published_date":"2010-11-18T02:00:00Z","last_updated_date":"2010-11-18T02:00:00Z","reference_number":"EMA/CVMP/EWP/81987/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-guideline-demonstration-palatability-veterinary-medicinal-products_en.pdf"},
    {"id":"16810","name":"Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requiremen...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-20 - 2016-07-31","first_published_date":"2016-04-20T19:15:00Z","last_updated_date":"2016-04-20T19:15:00Z","reference_number":"EMA/CHMP/213862/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-cpmp-ewp-558-95-rev-2-address-paediatric-specific-clinical-data-requiremen_en.pdf"},
    {"id":"16827","name":"Draft inventory of paediatric therapeutic needs - Respiratory","type":"other","status":"Draft: consultation closed","consultation_date":"2016-05-11 - 2016-07-11","first_published_date":"2016-05-11T19:20:00Z","last_updated_date":"2016-05-11T19:20:00Z","reference_number":"EMA/244726/2016","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-therapeutic-needs-respiratory_en.pdf"},
    {"id":"16960","name":"Draft guideline on carcinogenicity evaluation of medicinal products for the treatment of HIV infection","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2006-07-27 - 2007-01-31","first_published_date":"2006-07-27T04:00:00Z","last_updated_date":"2006-07-27T04:00:00Z","reference_number":"EMEA/CHMP/SWP/194898/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-carcinogenicity-evaluation-medicinal-products-treatment-hiv-infection_en.pdf"},
    {"id":"17014","name":"Draft non-clinical guideline on drug-induced hepatotoxicity","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2008-01-24 - 2008-08-30","first_published_date":"2008-01-24T02:00:00Z","last_updated_date":"2008-01-24T02:00:00Z","reference_number":"EMEA/CHMP/SWP/150115/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-non-clinical-guideline-drug-induced-hepatotoxicity_en.pdf"},
    {"id":"17065","name":"Draft guideline on the demonstration of palatability of veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-16 - 2013-05-31","first_published_date":"2012-11-19T12:30:00Z","last_updated_date":"2012-11-19T12:30:00Z","reference_number":"EMA/CVMP/EWP/206024/2011-CONSULTATION","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-demonstration-palatability-veterinary-medicinal-products_en.pdf"},
    {"id":"17212","name":"Draft guideline on veterinary medicinal products controlling varroa destructor parasitosis in bees","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-14 - 2010-04-30","first_published_date":"2009-10-19T04:00:00Z","last_updated_date":"2009-10-19T04:00:00Z","reference_number":"EMEA/CVMP/EWP/459883/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-veterinary-medicinal-products-controlling-varroa-destructor-parasitosis-bees_en.pdf"},
    {"id":"17364","name":"Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-01-11 - 2011-03-31","first_published_date":"2011-01-12T01:31:00Z","last_updated_date":"2011-01-12T01:31:00Z","reference_number":"EMA/759784/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-need-active-control-therapeutic-areas-where-use-placebo-deemed-ethical-and-one-or-more-established-medicines-are-available_en.pdf"},
    {"id":"17369","name":"Draft public statement on Chelidonium majus L., herba","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-01-15 - 2011-04-15","first_published_date":"2011-01-18T02:00:00Z","last_updated_date":"2011-01-18T02:00:00Z","reference_number":"EMA/HMPC/743927/2010","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-chelidonium-majus-l-herba_en.pdf"},
    {"id":"17420","name":"Draft guideline on the clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-01 - 2013-08-31","first_published_date":"2013-03-01T13:00:00Z","last_updated_date":"2013-03-01T13:00:00Z","reference_number":"EMA/CHMP/236981/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-duchenne-and-becker-muscular-dystrophy_en.pdf"},
    {"id":"17434","name":"Draft guideline on the clinical evaluation of direct acting antivirals for the treatment of chronic hepatitis - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-07 - 2016-12-31","first_published_date":"2016-07-07T16:30:00Z","last_updated_date":"2016-07-07T16:30:00Z","reference_number":"EMEA/CHMP/EWP/30039/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-direct-acting-antivirals-treatment-chronic-hepatitis-revision-1_en.pdf"},
    {"id":"17476","name":"Draft guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2017-01-31","first_published_date":"2016-08-01T13:30:00Z","last_updated_date":"2016-08-01T13:30:00Z","reference_number":"CPMP/EWP/2284/99 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-new-medicinal-products-treatment-crohns-disease-revision-2_en.pdf"},
    {"id":"17488","name":"Draft list of references supporting the assessment of Achillea millefolium L., flos","type":"herbal-references","status":"Draft","consultation_date":"2010-11-15 - 2011-02-15","first_published_date":"2010-11-09T02:00:00Z","last_updated_date":"2010-11-09T02:00:00Z","reference_number":"EMA/HMPC/149469/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-achillea-millefolium-l-flos_en.pdf"},
    {"id":"17552","name":"Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-28 - 2017-10-31","first_published_date":"2017-07-28T14:00:00Z","last_updated_date":"2017-07-28T14:00:00Z","reference_number":"EMA/CHMP/356875/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dronedarone-film-coated-tablets-400-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"17566","name":"Draft sorafenib product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423707/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-sorafenib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"17615","name":"Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-24 - 2014-10-15","first_published_date":"2014-07-24T18:15:00Z","last_updated_date":"2014-07-24T18:15:00Z","reference_number":"EMA/624809/2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-rules-procedures-organisation-and-conduct-public-hearings-pharmacovigilance-risk-assessment-committee-prac_en.pdf"},
    {"id":"17658","name":"Draft explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza Vaccines (CPMP/BWP/214/96) and of the core SmPC/PL for inactivated seasonal influenza vaccines (CMDh/128/2003/Rev5 and CMDh/129/2008/Rev3)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-08-01 - 2013-10-31","first_published_date":"2013-08-01T14:00:00Z","last_updated_date":"2013-08-01T14:00:00Z","reference_number":"EMA/CHMP/VWP/232674/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-explanatory-note-withdrawal-note-guidance-harmonisation-requirements-influenza-vaccines-cpmp-bwp-214-96-and-core-smpc-pl-inactivated-seasonal-influenza-vaccines-cmdh-128-2003-rev5-and-cmdh-129_en.pdf"},
    {"id":"17677","name":"Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T04:00:00Z","last_updated_date":"2013-12-12T12:00:00Z","reference_number":"EMA/816292/2011 Rev.1*","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-report_en.pdf"},
    {"id":"17859","name":"Concept paper on the need of the guideline on clinical investigation of medicinal products for the treatment of gout - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-14 - 2012-09-30","first_published_date":"2012-06-14T18:40:00Z","last_updated_date":"2012-06-14T18:40:00Z","reference_number":"EMA/CHMP/937321/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-investigation-medicinal-products-treatment-gout-first-version_en.pdf"},
    {"id":"17878","name":"Draft reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-26 - 2015-12-23","first_published_date":"2015-10-26T12:30:00Z","last_updated_date":"2015-10-26T12:30:00Z","reference_number":"EMA/CHMP/57760/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-reflection-paper-proposal-enhance-early-dialogue-facilitate-accelerated-assessment-priority-medicines-prime_en.pdf"},
    {"id":"17892","name":"Draft qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-12-20 - 2018-01-29","first_published_date":"2017-12-20T14:00:00Z","last_updated_date":"2017-12-20T14:00:00Z","reference_number":"EMA/810227/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-qualification-opinion-proactive-chronic-obstructive-pulmonary-disease-copd_en.pdf"},
    {"id":"17912","name":"Draft sirolimus product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/422569/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-sirolimus-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"17915","name":"Concept paper for the revision of the guideline on veterinary medicinal products for fluid therapy in case of diarrhoea","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-16 - 2017-03-31","first_published_date":"2016-12-16T20:00:00Z","last_updated_date":"2016-12-16T20:00:00Z","reference_number":"EMA/CVMP/EWP/707299/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-veterinary-medicinal-products-fluid-therapy-case-diarrhoea_en.pdf"},
    {"id":"17923","name":"Draft community herbal monograph on Arctium lappa L., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-01-14 - 2010-06-15","first_published_date":"2010-03-08T02:00:00Z","last_updated_date":"2010-03-08T02:00:00Z","reference_number":"EMA/HMPC/246763/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-arctium-lappa-l-radix_en.pdf"},
    {"id":"17949","name":"Draft Community list entry on Thymus vulgaris L. and Thymus zygis Loefl. ex L., aetheroleum","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2010-01-14 - 2010-05-15","first_published_date":"2010-02-12T02:09:21Z","last_updated_date":"2010-02-12T02:09:21Z","reference_number":"EMA/HMPC/255527/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-thymus-vulgaris-l-and-thymus-zygis-loefl-ex-l-aetheroleum_en.pdf"},
    {"id":"17994","name":"Draft qualification opinion on plasma fibrinogen as a prognostic biomarker (drug development tool) for all-cause mortality and COPD exacerbations in COPD subjects","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2017-03-30 - 2017-05-03","first_published_date":"2017-03-30T18:30:00Z","last_updated_date":"2017-03-30T18:30:00Z","reference_number":"EMA/474186/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-plasma-fibrinogen-prognostic-biomarker-drug-development-tool-all-cause-mortality-and-copd-exacerbations-copd-subjects_en.pdf"},
    {"id":"18024","name":"Revised European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) reflection paper on collecting data on consumption of antimicrobial agents per animal species, on technical units of measurement and indicator...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-12-18 - 2013-03-15","first_published_date":"2012-12-19T11:41:00Z","last_updated_date":"2013-10-15T18:35:00Z","reference_number":"EMA/286416/2012 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-european-surveillance-veterinary-antimicrobial-consumption-esvac-reflection-paper-collecting-data-consumption-antimicrobial-agents-animal-species-technical-units-measurement-and-indicator_en.pdf"},
    {"id":"18043","name":"Draft Community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-05-14 - 2013-11-15","first_published_date":"2013-07-31T20:30:00Z","last_updated_date":"2013-07-31T20:30:00Z","reference_number":"EMA/HMPC/307781/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-eucalyptus-globulus-labill-eucalyptus-polybractea-rt-baker-and-or-eucalyptus-smithii-rt-baker-aetheroleum_en.pdf"},
    {"id":"18061","name":"Draft guideline on the clinical development of medicinal products for the treatment of human-immunodeficiency-virus (HIV) infection (revision 3)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-09-30 - 2014-03-31","first_published_date":"2013-09-30T18:00:00Z","last_updated_date":"2013-10-07T20:00:00Z","reference_number":"EMEA/CPMP/EWP/633/02 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-treatment-human-immunodeficiency-virus-hiv-infection-revision-3_en.pdf"},
    {"id":"18093","name":"Draft guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-11 - 2016-04-30","first_published_date":"2016-02-11T11:55:00Z","last_updated_date":"2016-02-11T11:55:00Z","reference_number":"EMA/CHMP/BPWP/29205/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-anti-d-immunoglobulin-intramuscular-use_en.pdf"},
    {"id":"18170","name":"Draft European Union herbal monograph on Ricinus communis L., oleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-31","first_published_date":"2015-07-22T04:00:00Z","last_updated_date":"2015-07-22T04:00:00Z","reference_number":"EMA/HMPC/572974/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-ricinus-communis-l-oleum_en.pdf"},
    {"id":"18219","name":"Draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-04-12 - 2017-07-16","first_published_date":"2017-04-12T16:08:00Z","last_updated_date":"2017-04-12T16:08:00Z","reference_number":"EMA/HMPC/750269/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-arctostaphylos-uva-ursi-l-spreng-folium_en.pdf"},
    {"id":"18323","name":"Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2)","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T21:18:13Z","last_updated_date":"2017-03-30T19:00:00Z","reference_number":"EMA/838713/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-v-risk-management-systems-rev-2_en.pdf"},
    {"id":"18347","name":"Draft community herbal monograph on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-08-15 - 2010-12-15","first_published_date":"2010-08-20T04:00:00Z","last_updated_date":"2010-08-20T04:00:00Z","reference_number":"EMA/HMPC/246774/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cinnamomum-verum-j-s-presl-cinnamomum-zeylanicum-nees-cortex_en.pdf"},
    {"id":"18357","name":"Draft guideline on process validation - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-03-15 - 2012-10-31","first_published_date":"2012-04-13T15:25:00Z","last_updated_date":"2012-04-13T15:25:00Z","reference_number":"EMA/CHMP/CVMP/QWP/70278/2012-Rev1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-process-validation-revision-1_en.pdf"},
    {"id":"18405","name":"Draft reflection paper on the risk of antimicrobial resistance transfer from companion animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-10-21 - 2014-01-31","first_published_date":"2013-10-21T15:00:00Z","last_updated_date":"2013-10-21T15:00:00Z","reference_number":"EMA/CVMP/AWP/401740/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-risk-antimicrobial-resistance-transfer-companion-animals_en.pdf"},
    {"id":"18416","name":"Call for scientific data for the systematic review of the monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91104/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-foeniculum-vulgare-miller-subsp-vulgare-var-vulgare-aetheroleum_en.pdf"},
    {"id":"18482","name":"Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different ...","type":"other","status":"Draft: consultation closed","consultation_date":"2017-01-09 - 2017-04-30","first_published_date":"2017-01-09T16:15:00Z","last_updated_date":"2018-04-30T21:06:00Z","reference_number":"EMA/CHMP/CVMP/SWP/246844/2018","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-implementation-risk-based-prevention-cross-contamination-production-and-guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different_en.pdf"},
    {"id":"18593","name":"Draft qualification opinion of a novel data-driven model of disease progression and trial evaluation in mild and moderate Alzheimer’s disease","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2013-07-19 - 2013-08-27","first_published_date":"2013-07-19T16:00:00Z","last_updated_date":"2013-07-19T16:00:00Z","reference_number":"EMA/CHMP/SAWP/420174/2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-novel-data-driven-model-disease-progression-and-trial-evaluation-mild-and-moderate-alzheimers-disease_en.pdf"},
    {"id":"18604","name":"Concept paper on proposed revision to the Guideline for the conduct of efficacy studies for NSAIDs","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-19 - 2010-11-30","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-09-28T04:00:00Z","reference_number":"EMA/CVMP/EWP/62867/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-proposed-revision-guideline-conduct-efficacy-studies-nsaids_en.pdf"},
    {"id":"18669","name":"Draft guideline on Real Time Release Testing (formerly Guideline on Parametric Release)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-17 - 2010-08-31","first_published_date":"2010-03-03T02:00:00Z","last_updated_date":"2010-03-03T02:00:00Z","reference_number":"EMA/CHMP/QWP/811210/2009 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-real-time-release-testing-formerly-guideline-parametric-release_en.pdf"},
    {"id":"18675","name":"Draft guideline on validation of bionanalytical methods","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-11-20 - 2010-05-31","first_published_date":"2009-12-08T01:09:21Z","last_updated_date":"2009-12-08T01:09:21Z","reference_number":"EMEA/CHMP/EWP/192217/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-validation-bionanalytical-methods_en.pdf"},
    {"id":"18802","name":"Call for scientific data for use in HMPC assessment work on Erysimum officinale L., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-05-15","first_published_date":"2011-02-17T02:00:00Z","last_updated_date":"2011-02-17T02:00:00Z","reference_number":"EMA/HMPC/129740/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-erysimum-officinale-l-flos_en.pdf"},
    {"id":"18814","name":"Concept paper on the need for revision of the guideline of medical products used in weight control - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-10-01 - 2012-12-31","first_published_date":"2012-10-01T18:30:00Z","last_updated_date":"2012-10-01T18:30:00Z","reference_number":"EMA/CHMP/229823/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-medical-products-used-weight-control-revision-1_en.pdf"},
    {"id":"18850","name":"Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-03 - 2017-10-31","first_published_date":"2017-08-03T20:35:01Z","last_updated_date":"2017-08-03T20:35:01Z","reference_number":"EMA/CHMP/315234/2014/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-tadalafil-film-coated-tablets-25-mg-5-mg-10-mg-and-20-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"18856","name":"Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guidance CHMP/EWP/239/95 - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-04 - 2017-09-30","first_published_date":"2017-04-04T21:15:00Z","last_updated_date":"2017-04-04T21:15:00Z","reference_number":"CPMP/EWP/239/95 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-equivalence-studies-demonstration-therapeutic-equivalence-products-are-locally-applied-locally-acting-gastrointestinal-tract-addendum-guidance-chmp-ewp-239-95-revision-1_en.pdf"},
    {"id":"18909","name":"Draft guideline on the adventitious agent safety of urine-derived medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-22 - 2014-05-31","first_published_date":"2013-11-22T15:40:00Z","last_updated_date":"2013-11-22T15:40:00Z","reference_number":"EMA/CHMP/BWP/126802/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-adventitious-agent-safety-urine-derived-medicinal-products_en.pdf"},
    {"id":"18943","name":"Concept paper on the need for revision of guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-06-23 - 2011-09-30","first_published_date":"2011-07-08T04:00:00Z","last_updated_date":"2011-07-08T04:00:00Z","reference_number":"EMA/CHMP/CNSWP/257565/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-multiple-sclerosis_en.pdf"},
    {"id":"18977","name":"Draft guideline on good pharmacovigilance practices: Module I - Pharmacovigilance systems and their quality systems","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/541760/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-and-their-quality-systems_en.pdf"},
    {"id":"19001","name":"Draft VICH GL51: Quality: statistical evaluation of stability data","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-08 - 2012-06-12","first_published_date":"2011-12-20T16:15:00Z","last_updated_date":"2011-12-20T16:15:00Z","reference_number":"EMA/CVMP/VICH/858875/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl51-quality-statistical-evaluation-stability-data_en.pdf"},
    {"id":"19068","name":"Draft questions and answers on the haemagglutination inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-01 - 2018-07-31","first_published_date":"2018-02-01T14:58:00Z","last_updated_date":"2018-02-01T14:58:00Z","reference_number":"EMA/CHMP/BWP/426390/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-haemagglutination-inhibition-hi-test-qualification-influenza-vaccine-inactivated-seed-preparations-first-version_en.pdf"},
    {"id":"19131","name":"Draft European Union herbal monograph on Equisetum arvense L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-27 - 2015-10-31","first_published_date":"2015-07-27T14:00:00Z","last_updated_date":"2015-07-27T14:00:00Z","reference_number":"EMA/HMPC/278091/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-equisetum-arvense-l-herba_en.pdf"},
    {"id":"19139","name":"Draft European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Vision and Strategy 2016-2020","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-07 - 2016-06-30","first_published_date":"2016-04-07T19:30:00Z","last_updated_date":"2016-04-07T19:30:00Z","reference_number":"EMA/326299/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-european-surveillance-veterinary-antimicrobial-consumption-esvac-vision-and-strategy-2016-2020_en.pdf"},
    {"id":"19148","name":"Concept paper on the revision of the note for guidance on the quality, pre-clinical and clinical aspects of gene transfer medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-17 - 2010-03-31","first_published_date":"2010-01-13T01:09:21Z","last_updated_date":"2010-01-13T01:09:21Z","reference_number":"EMA/CHMP/GTWP/BWP/234523/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-quality-pre-clinical-and-clinical-aspects-gene-transfer-medicinal-products_en.pdf"},
    {"id":"19150","name":"Concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-16 - 2017-03-31","first_published_date":"2016-12-16T20:00:00Z","last_updated_date":"2016-12-16T20:00:00Z","reference_number":"EMA/CVMP/EWP/707573/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-veterinary-medicinal-products-zootechnical-purposes_en.pdf"},
    {"id":"19164","name":"Draft CVMP strategy on antimicrobials 2016-2020","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-11-17 - 2016-02-29","first_published_date":"2015-11-17T14:00:00Z","last_updated_date":"2015-11-17T14:00:00Z","reference_number":"EMA/CVMP/209189/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-cvmp-strategy-antimicrobials-2016-2020_en.pdf"},
    {"id":"19230","name":"Draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2018-03-08 - 2018-06-15","first_published_date":"2018-03-08T10:35:00Z","last_updated_date":"2018-03-08T10:35:00Z","reference_number":"EMA/HMPC/45508/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-hypericum-perforatum-l-herba-traditional-use-revision-1_en.pdf"},
    {"id":"19329","name":"Call for scientific data for use in HMPC assessment work on Epilobii herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-17T11:25:00Z","last_updated_date":"2014-02-17T11:25:00Z","reference_number":"EMA/HMPC/87611/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-epilobii-herba_en.pdf"},
    {"id":"19338","name":"Draft Quality Review of Documents recommendations on pack design and labelling for centrally authorised non-prescription human medicinal products","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2011-04-01 - 2011-06-30","first_published_date":"2011-04-02T03:31:00Z","last_updated_date":"2011-04-02T03:31:00Z","reference_number":"EMA/275297/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-quality-review-documents-recommendations-pack-design-and-labelling-centrally-authorised-non-prescription-human-medicinal-products_en.pdf"},
    {"id":"19387","name":"Concept paper for the revision of the note for guidance on the use of adjuvanted veterinary vaccines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-09-28 - 2016-12-31","first_published_date":"2016-09-28T17:35:00Z","last_updated_date":"2016-09-28T17:35:00Z","reference_number":"EMA/CVMP/IWP/867395/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-use-adjuvanted-veterinary-vaccines-revision-1_en.pdf"},
    {"id":"19392","name":"Call for scientific data for use in HMPC assessment work on Hieracium pilosella L., herba cum flore","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-04-15","first_published_date":"2012-01-03T12:03:00Z","last_updated_date":"2012-01-03T12:03:00Z","reference_number":"EMA/HMPC/890471/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-hieracium-pilosella-l-herba-cum-flore_en.pdf"},
    {"id":"19416","name":"Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., cortex – First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/125353/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-hamamelis-virginiana-l-cortex-first-version_en.pdf"},
    {"id":"19539","name":"Draft community herbal monograph on Arctostaphylos uvae ursi (L.) Spreng, folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-08-15 - 2010-12-15","first_published_date":"2010-08-18T04:00:00Z","last_updated_date":"2010-08-18T04:00:00Z","reference_number":"EMA/HMPC/573460/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-arctostaphylos-uvae-ursi-l-spreng-folium_en.pdf"},
    {"id":"19541","name":"Standard acute-myeloid-leukaemia paediatric investigation plan","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2013-02-21 - 2013-05-05","first_published_date":"2013-02-22T13:00:00Z","last_updated_date":"2013-02-22T13:00:00Z","reference_number":"EMA/288890/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/standard-acute-myeloid-leukaemia-paediatric-investigation-plan_en.pdf"},
    {"id":"19617","name":"Draft qualification opinion on in vitro hollow-fibre-system model of tuberculosis (HFS-TB)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-11-18 - 2015-01-09","first_published_date":"2014-11-18T16:00:00Z","last_updated_date":"2014-11-18T16:00:00Z","reference_number":"EMA/CHMP/SAWP/381716/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-vitro-hollow-fibre-system-model-tuberculosis-hfs-tb_en.pdf"},
    {"id":"19623","name":"Draft emtricitabine/tenofovir disoproxil product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423726/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-emtricitabine-tenofovir-disoproxil-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"19648","name":"Call for scientific data for the systematic review of the monograph on Thymus vulgaris L.; Thymus zygis Loefl. ex L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648276/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-thymus-vulgaris-l-thymus-zygis-loefl-ex-l-herba_en.pdf"},
    {"id":"19700","name":"Call for scientific data for use in HMPC assessment work on Ginkgo biloba L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-27T14:27:00Z","last_updated_date":"2011-10-27T14:27:00Z","reference_number":"EMA/HMPC/853775/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-ginkgo-biloba-l-folium_en.pdf"},
    {"id":"19709","name":"Draft functional specifications for the European Union portal and European Union database to be audited","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-10 - 2014-10-31","first_published_date":"2014-10-10T19:40:00Z","last_updated_date":"2014-10-10T19:40:00Z","reference_number":"EMA/42176/2014 corr","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-functional-specifications-european-union-portal-and-european-union-database-be-audited_en.pdf"},
    {"id":"19713","name":"Draft points to consider on frailty: Evaluation instruments for baseline characterisation of clinical trial populations - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-12-21 - 2016-05-31","first_published_date":"2015-12-21T13:05:00Z","last_updated_date":"2015-12-21T13:05:00Z","reference_number":"EMA/CHMP/778709/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-points-consider-frailty-evaluation-instruments-baseline-characterisation-clinical-trial-populations-first-version_en.pdf"},
    {"id":"19757","name":"Draft proposal for an addendum, on transparency, to the 'functional specifications for the European Union (EU) portal and EU database to be audited'","type":"other","status":"Draft: consultation closed","consultation_date":"2015-01-21 - 2015-02-18","first_published_date":"2015-01-21T02:00:00Z","last_updated_date":"2023-10-26T13:35:00Z","reference_number":"EMA/641479/2014","document_url":"https://www.ema.europa.eu/en/documents/other/draft-proposal-addendum-transparency-functional-specifications-european-union-eu-portal-and-eu-database-be-audited_en.pdf"},
    {"id":"19773","name":"Call for scientific data for the systematic review of the monograph on Vitex agnus-castus L., fructus - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669359/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-vitex-agnus-castus-l-fructus-first-version_en.pdf"},
    {"id":"19804","name":"Draft qualification opinion on the ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-09-16 - 2015-10-26","first_published_date":"2015-09-16T17:00:00Z","last_updated_date":"2015-09-16T17:00:00Z","reference_number":"EMA/CHMP/SAWP/513571/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-ingestible-sensor-system-medication-adherence-biomarker-measuring-patient-adherence-medication-clinical-trials_en.pdf"},
    {"id":"19812","name":"Draft guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-31 - 2013-07-31","first_published_date":"2013-01-31T19:20:00Z","last_updated_date":"2013-01-31T19:20:00Z","reference_number":"EMEA/CHMP/BMWP/118264/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-low-molecular-weight-heparins_en.pdf"},
    {"id":"19819","name":"Draft guideline on core summary of product characteristics and package leaflet for radiopharmaceuticals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-17 - 2011-04-25","first_published_date":"2011-03-30T04:00:00Z","last_updated_date":"2011-03-30T04:00:00Z","reference_number":"EMA/CHMP/167834/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-and-package-leaflet-radiopharmaceuticals_en.pdf"},
    {"id":"19842","name":"Draft guideline on good pharmacovigilance practices: Module II - Pharmacovigilance system master file","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/816573/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file_en.pdf"},
    {"id":"19865","name":"Second draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs)","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2013-11-14 - 2014-02-15","first_published_date":"2013-11-14T13:30:00Z","last_updated_date":"2013-11-14T13:30:00Z","reference_number":"EMA/HMPC/893108/2011 2nd draft","document_url":"https://www.ema.europa.eu/en/documents/public-statement/second-draft-public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas_en.pdf"},
    {"id":"19905","name":"Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies – Superseded","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-08-06 - 2018-10-31","first_published_date":"2018-08-06T19:13:00Z","last_updated_date":"2018-08-06T19:13:00Z","reference_number":"EMA/CHMP/459559/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-minimal-residual-disease-clinical-endpoint-multiple-myeloma-studies-superseded_en.pdf"},
    {"id":"19909","name":"Call for scientific data for the systematic review of the monograph on Rheum palmatum L.; Rheum officinale Baillon, radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648289/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-rheum-palmatum-l-rheum-officinale-baillon-radix_en.pdf"},
    {"id":"19975","name":"Draft inventory of paediatric therapeutic needs - Ophthalmology","type":"other","status":"Draft: consultation closed","consultation_date":"2014-05-09 - 2014-07-11","first_published_date":"2014-05-08T13:30:00Z","last_updated_date":"2014-05-08T13:30:00Z","reference_number":"EMA/PDCO/170932/2014","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-therapeutic-needs-ophthalmology_en.pdf"},
    {"id":"20015","name":"Draft revision of EudraVigilance access policy for medicines for human use","type":"other","status":"Draft: consultation closed","consultation_date":"2014-08-04 - 2014-09-15","first_published_date":"2014-08-04T19:00:00Z","last_updated_date":"2014-08-04T19:00:00Z","reference_number":"EMA/759287/2009 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/draft-revision-eudravigilance-access-policy-medicines-human-use_en.pdf"},
    {"id":"20161","name":"Call for scientific data for use in HMPC assessment work on Withania somnifera (L.) Dunal, radix - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558961/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-withania-somnifera-l-dunal-radix-first-version_en.pdf"},
    {"id":"20192","name":"Draft public statement on Piper methysticum G. Forst., rhizoma","type":"public-statement","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:35:00Z","last_updated_date":"2016-12-15T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-piper-methysticum-g-forst-rhizoma_en.pdf"},
    {"id":"20212","name":"Draft concept paper for a guideline on user safety of topically administered products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-03-24 - 2014-06-30","first_published_date":"2014-03-24T16:00:00Z","last_updated_date":"2014-03-24T16:00:00Z","reference_number":"EMA/CVMP/SWP/92311/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-guideline-user-safety-topically-administered-products_en.pdf"},
    {"id":"20235","name":"Draft Community herbal monograph on Rubus idaeus L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-03-12 - 2013-09-15","first_published_date":"2013-05-03T04:00:00Z","last_updated_date":"2013-05-03T04:00:00Z","reference_number":"EMA/HMPC/44211/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-rubus-idaeus-l-folium_en.pdf"},
    {"id":"20244","name":"Draft European Union herbal monograph on Origanum majorana L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2016-02-15 - 2016-05-15","first_published_date":"2016-02-15T18:15:00Z","last_updated_date":"2016-02-15T18:15:00Z","reference_number":"EMA/HMPC/166517/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-origanum-majorana-l-herba_en.pdf"},
    {"id":"20300","name":"List of references supporting the assessment of Withania somnifera (L.) Dunal, radix - First version","type":"herbal-references","status":"Draft","consultation_date":"2012-12-15 - 2013-04-15","first_published_date":"2012-12-10T02:00:00Z","last_updated_date":"2012-12-10T02:00:00Z","reference_number":"EMA/HMPC/733313/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-withania-somnifera-l-dunal-radix-first-version_en.pdf"},
    {"id":"20311","name":"Draft Community herbal monograph on Zingiberis rhizoma","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-08-15 - 2011-12-15","first_published_date":"2011-09-20T04:00:00Z","last_updated_date":"2011-09-20T04:00:00Z","reference_number":"EMA/HMPC/749154/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-zingiberis-rhizoma_en.pdf"},
    {"id":"20464","name":"Concept paper on qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and analyses","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-06-27 - 2014-09-30","first_published_date":"2014-06-27T20:30:00Z","last_updated_date":"2014-06-27T20:30:00Z","reference_number":"EMA/CHMP/211243/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-qualification-and-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-and-analyses_en.pdf"},
    {"id":"20548","name":"Draft guideline on core summary of product characteristics for human plasma derived and recombinant coagulation factor VIII products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-01 - 2015-07-01","first_published_date":"2015-06-01T19:00:00Z","last_updated_date":"2015-06-01T19:00:00Z","reference_number":"EMA/CHMP/BPWP/1619/1999 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-human-plasma-derived-and-recombinant-coagulation-factor-viii-products-revision-2_en.pdf"},
    {"id":"20600","name":"Draft policy 70: Publication and access to clinical-trial data","type":"other","status":"Draft: consultation closed","consultation_date":"2013-06-24 - 2013-09-30","first_published_date":"2013-06-24T18:00:00Z","last_updated_date":"2013-06-24T18:00:00Z","reference_number":"EMA/240810/2013","document_url":"https://www.ema.europa.eu/en/documents/other/draft-policy-70-publication-and-access-clinical-trial-data_en.pdf"},
    {"id":"20633","name":"Call for scientific data for the systematic review of the monograph on Olea europaea L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/845010/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-olea-europaea-l-folium_en.pdf"},
    {"id":"20643","name":"Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-31 - 2019-07-31","first_published_date":"2018-07-31T18:00:00Z","last_updated_date":"2018-07-31T18:00:00Z","reference_number":"EMA/CAT/GTWP/671639/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-non-clinical-and-clinical-aspects-medicinal-products-containing-genetically-modified-cells-revision-1_en.pdf"},
    {"id":"20663","name":"Concept paper on revision of guidelines on the clinical investigation and core SmPC of recombinant and human plasma-derived factor VIII products (EMA/CHMP/BPWP/144533/2009 rev. 1)  (EMA/CHMP/BPWP/1619/1999 rev. 2)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-09-30","first_published_date":"2016-08-01T20:00:00Z","last_updated_date":"2016-08-01T20:00:00Z","reference_number":"EMA/CHMP/BPWP/383118/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-clinical-investigation-and-core-smpc-recombinant-and-human-plasma-derived-factor-viii-products-ema-chmp-bpwp-144533-2009-rev-1-ema-chmp-bpwp-1619-1999-rev-2_en.pdf"},
    {"id":"20670","name":"Draft community herbal monograph on Cynara scolymus L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-01-15 - 2011-04-15","first_published_date":"2011-01-18T02:00:00Z","last_updated_date":"2011-01-18T02:00:00Z","reference_number":"EMA/HMPC/150218/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cynara-scolymus-l-folium_en.pdf"},
    {"id":"20796","name":"Call for scientific data for use in HMPC assessment work on Hyoscyamus niger L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-04-15","first_published_date":"2012-01-03T11:50:00Z","last_updated_date":"2012-01-03T11:50:00Z","reference_number":"EMA/HMPC/890472/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-hyoscyamus-niger-l-herba_en.pdf"},
    {"id":"20803","name":"Call for scientific data for the systematic review of the monograph on Cynara scolymus L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/844975/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-cynara-scolymus-l-folium_en.pdf"},
    {"id":"20823","name":"Draft guideline on detection and management of duplicate individual cases and individual case safety reports","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-29 - 2010-09-29","first_published_date":"2010-06-29T04:00:00Z","last_updated_date":"2010-06-29T04:00:00Z","reference_number":"EMA/13432/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-detection-and-management-duplicate-individual-cases-and-individual-case-safety-reports_en.pdf"},
    {"id":"20906","name":"Reflection paper on co-development of pharmacogenomic biomarkers and Assays in the context of drug development","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-11-30","first_published_date":"2010-07-12T04:00:00Z","last_updated_date":"2010-07-12T04:00:00Z","reference_number":"EMA/CHMP/641298/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-co-development-pharmacogenomic-biomarkers-and-assays-context-drug-development_en.pdf"},
    {"id":"20966","name":"Call for scientific data for use in HMPC assessment work on Echinaceae angustifolia DC., radix – First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/125289/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-echinaceae-angustifolia-dc-radix-first-version_en.pdf"},
    {"id":"20968","name":"Draft guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-01-12 - 2012-05-31","first_published_date":"2012-02-09T17:10:00Z","last_updated_date":"2012-02-09T17:10:00Z","reference_number":"EMEA/CHMP/CVMP/QWP/17760/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-near-infrared-spectroscopy-pharmaceutical-industry-and-data-requirements-new-submissions-and-variations-revision-2_en.pdf"},
    {"id":"21002","name":"Draft guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-08 - 2013-06-30","first_published_date":"2013-01-08T14:00:00Z","last_updated_date":"2013-01-08T14:00:00Z","reference_number":"EMA/CHMP/CVMP/SWP/169430/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-setting-health-based-exposure-limits-use-risk-identification-manufacture-different-medicinal-products-shared-facilities_en.pdf"},
    {"id":"21041","name":"Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-08-15 - 2019-02-15","first_published_date":"2018-08-15T14:20:00Z","last_updated_date":"2018-08-15T14:20:00Z","reference_number":"EMEA/CHMP/BMWP/31329/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-biological-medicinal-products-containing-recombinant-granulocyte-colony-stimulating-factor-rg-csf-revision-1_en.pdf"},
    {"id":"21074","name":"Draft exenatide powder and solvent for prolonged-release suspension for injection, 2 mg, and powder and solvent for prolonged-release suspension for injection in pre-filled pen, 2 mg product-specific bioequivalence guida...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-10-31","first_published_date":"2016-08-01T17:00:00Z","last_updated_date":"2016-08-01T17:00:00Z","reference_number":"EMA/CHMP/474782/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-exenatide-powder-and-solvent-prolonged-release-suspension-injection-2-mg-and-powder-and-solvent-prolonged-release-suspension-injection-pre-filled-pen-2-mg-product-specific-bioequivalence-guida_en.pdf"},
    {"id":"21086","name":"ICH guideline S10 - Guidance on photosafety evaluation of pharmaceuticals - Step 3","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2012-12-17 - 2013-03-01","first_published_date":"2012-12-17T15:55:00Z","last_updated_date":"2012-12-17T15:55:00Z","reference_number":"EMA/CHMP/ICH/752211/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ich-guideline-s10-guidance-photosafety-evaluation-pharmaceuticals-step-3_en.pdf"},
    {"id":"21132","name":"Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-30 - 2018-05-01","first_published_date":"2017-10-30T17:00:00Z","last_updated_date":"2017-10-30T17:00:00Z","reference_number":"EMA/CHMP/257022/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-medicinal-products-indicated-prophylaxis-or-treatment-respiratory-syncytial-virus-rsv-disease-first-version_en.pdf"},
    {"id":"21205","name":"Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q3D on elemental impurities - Step 3 - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-08-08 - 2013-12-31","first_published_date":"2013-08-08T20:40:00Z","last_updated_date":"2013-08-08T20:40:00Z","reference_number":"EMA/CHMP/ICH/353369/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q3d-elemental-impurities-step-3-first-version_en.pdf"},
    {"id":"21221","name":"Draft European Union herbal monograph on Carum carvi L., fructus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-12-22 - 2015-03-15","first_published_date":"2014-12-22T18:30:00Z","last_updated_date":"2014-12-22T18:30:00Z","reference_number":"EMA/HMPC/715092/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-carum-carvi-l-fructus_en.pdf"},
    {"id":"21337","name":"Concept paper on new guidance for importers of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-05-29 - 2015-08-29","first_published_date":"2015-05-29T15:10:00Z","last_updated_date":"2015-05-29T15:10:00Z","reference_number":"EMA/238299/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-new-guidance-importers-medicinal-products_en.pdf"},
    {"id":"21378","name":"Draft guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-09-01 - 2016-11-30","first_published_date":"2016-09-01T20:00:00Z","last_updated_date":"2016-09-01T20:00:00Z","reference_number":"EMA/HMPC/104613/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-assessment-clinical-safety-and-efficacy-preparation-european-union-herbal-monographs-well-established-and-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"21403","name":"Draft public statement on the use of herbal medicinal products containing thujone","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-01-27 - 2011-05-15","first_published_date":"2011-02-22T02:00:00Z","last_updated_date":"2011-02-22T02:00:00Z","reference_number":"EMA/HMPC/732886/2010","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-use-herbal-medicinal-products-containing-thujone_en.pdf"},
    {"id":"21486","name":"Call for scientific data for use in HMPC assessment work on Carum carvi L., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-06-15 - 2012-10-15","first_published_date":"2012-06-15T15:30:00Z","last_updated_date":"2012-06-15T15:30:00Z","reference_number":"EMA/HMPC/356252/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-carum-carvi-l-aetheroleum_en.pdf"},
    {"id":"21497","name":"Draft guideline on clinical evaluation of medicinal products used in weight control - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-31 - 2015-01-31","first_published_date":"2014-07-31T14:00:00Z","last_updated_date":"2014-07-31T14:00:00Z","reference_number":"EMA/CHMP/311805/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-medicinal-products-used-weight-control-revision-1_en.pdf"},
    {"id":"21525","name":"Draft list of references for assessment of Quercus robur L., Quercus petrea.(Matt.) Liebl. and Quercus pubescens Willd., Quercus cortex (oak bark)","type":"herbal-references","status":"Draft","consultation_date":"2010-01-14 - 2010-05-15","first_published_date":"2010-03-08T02:00:00Z","last_updated_date":"2010-03-08T02:00:00Z","reference_number":"EMA/HMPC/3205/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-assessment-quercus-robur-l-quercus-petreamatt-liebl-and-quercus-pubescens-willd-quercus-cortex-oak-bark_en.pdf"},
    {"id":"21536","name":"Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-08 - 2016-10-14","first_published_date":"2016-08-08T19:00:00Z","last_updated_date":"2016-08-08T19:00:00Z","reference_number":"EMA/873138/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-vi-management-and-reporting-adverse-reactions-medicinal-products-rev-2_en.pdf"},
    {"id":"21542","name":"Draft European Union herbal monograph on Prunus africana (Hook f.) Kalkm., cortex","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T18:30:00Z","last_updated_date":"2015-12-15T18:30:00Z","reference_number":"EMA/HMPC/680626/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-prunus-africana-hook-f-kalkm-cortex_en.pdf"},
    {"id":"21713","name":"Call for scientific data for use in HMPC assessment work on Phaseolus vulgaris L., fructus – Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/131795/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-phaseolus-vulgaris-l-fructus-revision-1_en.pdf"},
    {"id":"21721","name":"Concept paper on the need for revision of the position paper on indications for veterinary vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-10-13 - 2011-12-31","first_published_date":"2011-10-25T19:00:00Z","last_updated_date":"2011-10-25T19:00:00Z","reference_number":"EMA/CVMP/IWP/785621/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-position-paper-indications-veterinary-vaccines_en.pdf"},
    {"id":"21750","name":"Call for scientific data for the systematic review of the monograph on Cimicifuga racemosa (L.) Nutt., rhizome - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669360/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-cimicifuga-racemosa-l-nutt-rhizome-first-version_en.pdf"},
    {"id":"21762","name":"Draft Community herbal monograph on Hieracium pilosella L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-08-04 - 2014-10-31","first_published_date":"2014-08-04T16:30:00Z","last_updated_date":"2014-08-04T16:30:00Z","reference_number":"EMA/HMPC/680374/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-hieracium-pilosella-l-herba_en.pdf"},
    {"id":"21807","name":"Draft guideline on non-clinical local tolerance testing of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-04-30 - 2014-07-31","first_published_date":"2014-04-30T18:40:00Z","last_updated_date":"2014-04-30T18:40:00Z","reference_number":"EMA/CHMP/SWP/2145/2000 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-local-tolerance-testing-medicinal-products_en.pdf"},
    {"id":"21841","name":"Call for scientific data for use in HMPC assessment work on Origanum dictamnus L., herba - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558967/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-origanum-dictamnus-l-herba-first-version_en.pdf"},
    {"id":"22028","name":"Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2011-12-31","first_published_date":"2011-10-03T18:35:00Z","last_updated_date":"2011-10-03T18:35:00Z","reference_number":"EMA/CHMP/BMWP/572828/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues_en.pdf"},
    {"id":"22032","name":"Concept paper on the testing strategy and risk assessment for plants in the Phase II of the environmental risk assessment for veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-18 - 2015-09-30","first_published_date":"2015-06-18T19:40:00Z","last_updated_date":"2015-06-18T19:40:00Z","reference_number":"EMA/CVMP/ERA/698394/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-testing-strategy-and-risk-assessment-plants-phase-ii-environmental-risk-assessment-veterinary-medicinal-products_en.pdf"},
    {"id":"22042","name":"Concept paper on use of aminoglycosides in animals in the European Union: Development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-23 - 2014-10-31","first_published_date":"2014-07-23T16:00:00Z","last_updated_date":"2014-07-23T16:00:00Z","reference_number":"EMA/CVMP/AWP/158821/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-use-aminoglycosides-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"22078","name":"Draft dabigatran etexilate, hard capsules, 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-12-22 - 2017-03-31","first_published_date":"2016-12-22T14:00:00Z","last_updated_date":"2016-12-22T14:00:00Z","reference_number":"EMA/CHMP/805498/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dabigatran-etexilate-hard-capsules-75-mg-110-mg-and-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"22094","name":"Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-04-03 - 2018-05-16","first_published_date":"2018-04-03T16:00:00Z","last_updated_date":"2018-04-03T16:00:00Z","reference_number":"EMA/189939/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-consultation-concerning-european-union-template-good-manufacturing-practice-gmp-non-compliance-statement_en.pdf"},
    {"id":"22097","name":"Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-05-30 - 2012-11-30","first_published_date":"2012-05-30T15:30:00Z","last_updated_date":"2012-05-30T15:30:00Z","reference_number":"EMA/CHMP/325170/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-prevention-venous-thromboembolism-vte-patients-undergoing-high-vte-risk-surgery-revision-2_en.pdf"},
    {"id":"22105","name":"Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-09-18 - 2018-03-31","first_published_date":"2017-09-18T16:38:00Z","last_updated_date":"2017-09-18T16:38:00Z","reference_number":"EMA/CVMP/IWP/105506/2007-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-bluetongue-bt-and-foot-and-mouth-disease-fmd-revision-1_en.pdf"},
    {"id":"22180","name":"Questions and answers on benzalkonium chloride in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-06-30 - 2014-09-30","first_published_date":"2014-06-30T14:10:00Z","last_updated_date":"2014-06-30T14:10:00Z","reference_number":"EMA/495737/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-benzalkonium-chloride-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"22232","name":"Annex I variation application(s) content for live attenuated influenza vaccines","type":"regulatory-procedural-guideline","status":"Draft","consultation_date":"2010-12-16 - 2011-03-31","first_published_date":"2010-12-15T02:00:00Z","last_updated_date":"2010-12-15T02:00:00Z","reference_number":"EMA/CHMP/BWP/577998/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-i-variation-applications-content-live-attenuated-influenza-vaccines_en.pdf"},
    {"id":"22324","name":"Call for scientific data for the periodic review of the monograph on Quercus robur L.; Quercus petraea (Matt.) Liebl.; Quercus pubescens Willd., cortex","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/188889/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-quercus-robur-l-quercus-petraea-matt-liebl-quercus-pubescens-willd-cortex_en.pdf"},
    {"id":"22351","name":"Draft concept paper on revision of annex 17 of the good-manufacturing-practice guide","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-27 - 2013-02-28","first_published_date":"2012-11-27T10:40:00Z","last_updated_date":"2012-11-27T10:40:00Z","reference_number":"EMA/INS/GMP/705479/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-annex-17-good-manufacturing-practice-guide_en.pdf"},
    {"id":"22388","name":"Concept paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-01 - 2015-08-31","first_published_date":"2015-06-01T20:00:00Z","last_updated_date":"2015-06-01T20:00:00Z","reference_number":"EMA/HMPC/217631/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-quality-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"22405","name":"Draft Levodopa/Carbidopa/Entacapone film-coated tablet 200mg/50mg/200mg, 175mg/43.75mg/200mg, 150mg/37.5mg/200mg, 125mg/31.25mg/200mg, 100mg/25mg/200mg, 75mg/18.75mg/200mg and 50mg/12.5mg/200mg product-specific bioequiva...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-02 - 2016-07-31","first_published_date":"2016-05-02T13:00:00Z","last_updated_date":"2016-05-02T13:00:00Z","reference_number":"EMA/CHMP/162889/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-levodopa-carbidopa-entacapone-film-coated-tablet-200mg-50mg-200mg-175mg-4375mg-200mg-150mg-375mg-200mg-125mg-3125mg-200mg-100mg-25mg-200mg-75mg-1875mg-200mg-and-50mg-125mg-200mg-product-specific_en.pdf"},
    {"id":"22488","name":"Lessons learned from the review of the labelling of centrally authorised pandemic vaccines","type":"scientific-guideline","status":"Adopted","consultation_date":"2014-02-20 - 2014-05-20","first_published_date":"2014-02-20T11:00:00Z","last_updated_date":"2016-01-28T18:15:00Z","reference_number":"EMA/467700/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lessons-learned-review-labelling-centrally-authorised-pandemic-vaccines_en.pdf"},
    {"id":"22502","name":"Draft guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-03 - 2016-07-31","first_published_date":"2016-02-03T13:00:00Z","last_updated_date":"2016-02-03T13:00:00Z","reference_number":"EMA/CVMP/QWP/66781/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-and-residue-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market_en.pdf"},
    {"id":"22558","name":"Concept paper on the need for revision of the note for guidance on photosafety testing","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2008-01-24 - 2008-05-31","first_published_date":"2008-01-24T02:00:00Z","last_updated_date":"2008-01-24T02:00:00Z","reference_number":"EMEA/CHMP/SWP/534549/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-photosafety-testing_en.pdf"},
    {"id":"22565","name":"Draft list of references supporting the assessment of Chamaemelum nobile (L.) All., flos","type":"herbal-references","status":"Draft","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-03-02T02:00:00Z","last_updated_date":"2011-03-02T02:00:00Z","reference_number":"EMA/HMPC/560733/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"22617","name":"Draft ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-28 - 2017-01-28","first_published_date":"2016-07-28T20:00:00Z","last_updated_date":"2016-09-22T20:00:00Z","reference_number":"EMA/CHMP/ICH/453276/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-e17-general-principles-planning-and-design-multi-regional-clinical-trials-step-2b-first-version_en.pdf"},
    {"id":"22626","name":"Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-10-18 - 2014-01-31","first_published_date":"2013-10-18T19:00:00Z","last_updated_date":"2013-10-18T19:00:00Z","reference_number":"EMA/CVMP/SWP/285070/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-approach-towards-harmonisation-withdrawal-periods_en.pdf"},
    {"id":"22643","name":"Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-02-18 - 2010-08-31","first_published_date":"2010-03-25T02:00:00Z","last_updated_date":"2010-03-25T02:00:00Z","reference_number":"CPMP/EWP/558/95 rev 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-2_en.pdf"},
    {"id":"22672","name":"Draft concept paper on guideline on the clinical investigation of human normal immunoglobulin for intravenous administration and core summary of product characteristics","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-08-01 - 2014-10-31","first_published_date":"2014-08-01T19:30:00Z","last_updated_date":"2014-08-01T19:30:00Z","reference_number":"EMA/CHMP/BPWP/572805/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-and-core-summary-product-characteristics_en.pdf"},
    {"id":"22707","name":"Draft guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-27 - 2012-08-24","first_published_date":"2012-06-27T16:57:57Z","last_updated_date":"2012-06-27T16:57:57Z","reference_number":"EMA/119871/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-iii-pharmacovigilance-inspections_en.pdf"},
    {"id":"22711","name":"Draft European Union herbal monograph on Glycine max (L.) Merr., oleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2016-07-25 - 2016-10-31","first_published_date":"2016-07-25T16:30:00Z","last_updated_date":"2016-07-25T16:30:00Z","reference_number":"EMA/HMPC/338914/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-glycine-max-l-merr-oleum_en.pdf"},
    {"id":"22730","name":"Draft guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-07-19 - 2014-01-15","first_published_date":"2013-07-19T15:20:00Z","last_updated_date":"2013-07-19T15:20:00Z","reference_number":"CPMP/EWP/785/97 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-medicinal-products-treatment-irritable-bowel-syndrome-revision-1_en.pdf"},
    {"id":"22767","name":"Draft public statement on the use of herbal medicinal products containing pulegone and menthofuran - Revision 1","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2014-12-22 - 2015-03-31","first_published_date":"2014-12-22T12:30:00Z","last_updated_date":"2014-12-22T12:30:00Z","reference_number":"EMA/HMPC/138386/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-use-herbal-medicinal-products-containing-pulegone-and-menthofuran-revision-1_en.pdf"},
    {"id":"22868","name":"Concept paper on the need for revision of the Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence\n\n(CPMP/EWP/18/01)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-07-31","first_published_date":"2010-04-30T04:00:00Z","last_updated_date":"2010-05-20T04:00:00Z","reference_number":"EMA/CHMP/EWP/68523/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-urinary-incontinence-cpmp-ewp-18-01_en.pdf"},
    {"id":"22929","name":"Draft guideline on setting specifications for related impurities in antibiotics","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2011-01-31","first_published_date":"2010-07-30T04:00:00Z","last_updated_date":"2010-07-30T04:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/199250/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-setting-specifications-related-impurities-antibiotics_en.pdf"},
    {"id":"22944","name":"Draft Community herbal monograph on Solanum dulcamara L., stipites","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-04-15 - 2012-08-15","first_published_date":"2012-05-10T04:00:00Z","last_updated_date":"2012-05-10T04:00:00Z","reference_number":"EMA/HMPC/734361/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-solanum-dulcamara-l-stipites_en.pdf"},
    {"id":"22950","name":"Draft VICH GL36: Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological acceptable daily intake - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-10 - 2011-09-14","first_published_date":"2011-04-07T04:00:00Z","last_updated_date":"2011-04-07T04:00:00Z","reference_number":"EMA/CVMP/VICH/467/2003-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl36-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-microbiological-acceptable-daily-intake-revision-1_en.pdf"},
    {"id":"22959","name":"Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 2","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-09 - 2015-07-15","first_published_date":"2015-04-09T20:30:00Z","last_updated_date":"2015-04-09T20:30:00Z","reference_number":"EMA/HMPC/71049/2007 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-revision-2_en.pdf"},
    {"id":"22960","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-10-25 - 2017-01-31","first_published_date":"2016-10-25T20:45:00Z","last_updated_date":"2016-10-25T20:45:00Z","reference_number":"EMA/CHMP/179692/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-epileptic-disorders-revision-2_en.pdf"},
    {"id":"22997","name":"Draft guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2017-01-31","first_published_date":"2016-08-01T13:30:00Z","last_updated_date":"2016-08-01T13:30:00Z","reference_number":"CHMP/EWP/18463/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf"},
    {"id":"22998","name":"Draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-08-15 - 2013-02-15","first_published_date":"2012-08-15T14:17:14Z","last_updated_date":"2012-08-15T14:17:14Z","reference_number":"EMA/CHMP/450916/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-prevention-stroke-and-systemic-embolic-events-patients-non-valvular-atrial-fibrillation_en.pdf"},
    {"id":"23019","name":"Call for scientific data for use in HMPC assessment work on Ricini oleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-14T18:45:00Z","last_updated_date":"2014-02-14T18:45:00Z","reference_number":"EMA/HMPC/87631/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-ricini-oleum_en.pdf"},
    {"id":"23032","name":"Reflection paper on risk-based quality management in clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-06-15 - 2012-02-15","first_published_date":"2011-08-05T04:00:00Z","last_updated_date":"2011-08-05T04:00:00Z","reference_number":"EMA/INS/GCP/394194/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-based-quality-management-clinical-trials_en.pdf-0"},
    {"id":"23038","name":"Draft guideline on the clinical investigation of medicinal products for the treatment of urinary incontinence (revision 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-11-20 - 2012-05-31","first_published_date":"2011-11-23T02:00:00Z","last_updated_date":"2011-12-01T18:46:00Z","reference_number":"CPMP/EWP/18/01/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-urinary-incontinence-revision-1_en.pdf"},
    {"id":"23044","name":"Concept paper on the need for a guideline on the treatment of Duchenne and Becker muscular dystrophy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-06-23 - 2011-09-30","first_published_date":"2011-07-08T04:00:00Z","last_updated_date":"2011-07-08T04:00:00Z","reference_number":"EMA/CHMP/CNSWP/236981/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-treatment-duchenne-and-becker-muscular-dystrophy_en.pdf"},
    {"id":"23055","name":"Concept paper on non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products / traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-27 - 2012-10-15","first_published_date":"2012-06-27T15:30:00Z","last_updated_date":"2012-06-27T15:30:00Z","reference_number":"EMA/HMPC/312890/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-non-pharmacopoeial-reference-standards-herbal-substances-herbal-preparations-and-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"23058","name":"Second draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-04-30 - 2014-07-31","first_published_date":"2014-04-30T18:40:00Z","last_updated_date":"2014-04-30T18:40:00Z","reference_number":"EMEA/CHMP/BMWP/32775/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/second-draft-guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-insulin-and-insulin-analogues_en.pdf"},
    {"id":"23076","name":"VICH Topic Gl46: at step 4: Guideline on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residu...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-10 - 2010-05-20","first_published_date":"2009-12-22T02:00:00Z","last_updated_date":"2010-05-10T04:00:00Z","reference_number":"EMEA/CVMP/VICH/463072/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-topic-gl46-step-4-guideline-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-animals-metabolism-study-determine-quantity-and-identify-nature-residu_en.pdf"},
    {"id":"23079","name":"Draft guideline on the warning on transmissible agents in summary of product characteristics (SmPCs) and package leaflets for plasma-derived medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-17 - 2011-04-30","first_published_date":"2011-02-23T02:00:00Z","last_updated_date":"2011-02-23T02:00:00Z","reference_number":"EMA/CHMP/BWP/360642/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-warning-transmissible-agents-summary-product-characteristics-smpcs-and-package-leaflets-plasma-derived-medicinal-products_en.pdf"},
    {"id":"23091","name":"Concept paper on the revision of the guideline on similar biological medicinal product","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-11-17 - 2012-02-29","first_published_date":"2011-11-24T10:50:00Z","last_updated_date":"2011-11-24T10:50:00Z","reference_number":"EMA/CHMP/BMWP/572643/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-similar-biological-medicinal-product_en.pdf"},
    {"id":"23130","name":"Draft guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling with...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-27 - 2015-09-30","first_published_date":"2015-07-27T19:00:00Z","last_updated_date":"2015-07-27T19:00:00Z","reference_number":"EMA/CHMP/509951/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-scientific-application-and-practical-arrangements-necessary-implement-regulation-ec-no-507-2006-conditional-marketing-authorisation-medicinal-products-human-use-falling_en.pdf"},
    {"id":"23174","name":"Draft European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium – Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-10-12 - 2018-01-12","first_published_date":"2017-10-12T14:30:00Z","last_updated_date":"2017-10-12T14:30:00Z","reference_number":"EMA/HMPC/625849/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-senna-alexandrina-mill-cassia-senna-l-cassia-angustifolia-vahl-folium-revision-1_en.pdf"},
    {"id":"23192","name":"Draft guideline on clinical investigation of medicinal products in the treatment of schizophrenia","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-22 - 2011-08-31","first_published_date":"2011-02-22T02:00:00Z","last_updated_date":"2011-02-22T02:00:00Z","reference_number":"CHMP/40072/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-schizophrenia_en.pdf"},
    {"id":"23202","name":"Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-12-18 - 2018-12-18","first_published_date":"2017-12-18T18:00:00Z","last_updated_date":"2017-12-18T18:00:00Z","reference_number":"EMA/CHMP/ICH/804273/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management-step-2b-first-version_en.pdf"},
    {"id":"23237","name":"Draft guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-26 - 2017-08-31","first_published_date":"2017-04-26T04:00:00Z","last_updated_date":"2017-04-26T04:00:00Z","reference_number":"EMA/CHMP/649301/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-sodium-iodide-131i-therapy-capsule_en.pdf"},
    {"id":"23270","name":"Draft guideline on the clinical development of medicinal products intended for the treatment of pain","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-05-30 - 2013-11-30","first_published_date":"2013-05-30T17:00:00Z","last_updated_date":"2013-05-30T17:00:00Z","reference_number":"EMA/CHMP/970057/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-intended-treatment-pain_en.pdf"},
    {"id":"23292","name":"Procedure for the systematic review of European Union herbal monographs and/or European Union list entries and supporting documents","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"2011-07-12 - 2011-11-15","first_published_date":"2011-07-20T04:00:00Z","last_updated_date":"2015-04-20T13:20:00Z","reference_number":"EMA/HMPC/124695/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedure-systematic-review-european-union-herbal-monographs-and-or-european-union-list-entries-and-supporting-documents_en.pdf"},
    {"id":"23298","name":"Call for scientific data for use in HMPC assessment work on Rubus idaeus L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-17T19:44:00Z","last_updated_date":"2011-10-17T19:44:00Z","reference_number":"EMA/HMPC/778980/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-rubus-idaeus-l-folium_en.pdf"},
    {"id":"23300","name":"Draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-03 - 2014-12-31","first_published_date":"2014-10-03T20:00:00Z","last_updated_date":"2014-10-03T20:00:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/450091/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-regulatory-acceptance-3r-replacement-reduction-refinement-testing-approaches_en.pdf"},
    {"id":"23314","name":"Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-03-01 - 2014-08-31","first_published_date":"2014-02-28T18:00:00Z","last_updated_date":"2014-02-28T18:00:00Z","reference_number":"EMA/83874/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-pharmacokinetics-medicinal-products-patients-decreased-renal-function_en.pdf"},
    {"id":"23417","name":"Draft guideline on quality of biological active substances produced by transgene expression in animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-05-31 - 2012-11-30","first_published_date":"2012-05-31T15:25:12Z","last_updated_date":"2012-05-31T15:25:12Z","reference_number":"EMA/CHMP/BWP/159188/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-biological-active-substances-produced-transgene-expression-animals_en.pdf"},
    {"id":"23497","name":"Draft paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-11-30","first_published_date":"2010-06-04T04:00:00Z","last_updated_date":"2010-06-04T04:00:00Z","reference_number":"EMA/CHMP/EWP/213972/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paediatric-addendum-chmp-guideline-clinical-investigations-medicinal-products-treatment-pulmonary-arterial-hypertension_en.pdf"},
    {"id":"23523","name":"Draft guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-12 - 2013-06-12","first_published_date":"2013-04-12T19:55:00Z","last_updated_date":"2013-04-12T19:55:00Z","reference_number":"EMA/109434/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-p-i-vaccines-prophylaxis-against-infectious-diseases-definitions-inclusion-gvp-annex-i_en.pdf"},
    {"id":"23588","name":"Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2012-03-31","first_published_date":"2011-10-11T12:51:00Z","last_updated_date":"2011-10-11T12:51:00Z","reference_number":"EMA/CHMP/185423/2010, Rev 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-depression-revision-2_en.pdf"},
    {"id":"23624","name":"Concept paper on the need for revision of the note for guidance on clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/EWP/559/95)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-07-31","first_published_date":"2010-04-30T04:00:00Z","last_updated_date":"2010-04-30T04:00:00Z","reference_number":"EMA/CHMP/EWP/179360/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-schizophrenia-cpmp-ewp-559-95_en.pdf"},
    {"id":"23668","name":"Draft guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-07-26 - 2012-09-21","first_published_date":"2012-07-26T20:15:04Z","last_updated_date":"2012-07-26T20:15:04Z","reference_number":"EMA/228028/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-iv-pharmacovigilance-audits_en.pdf"},
    {"id":"23734","name":"Draft agomelatine oral tablet 25 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-31 - 2018-04-30","first_published_date":"2018-01-31T14:15:00Z","last_updated_date":"2018-01-31T14:15:00Z","reference_number":"EMA/CHMP/800802/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-agomelatine-oral-tablet-25-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"23743","name":"The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health","type":"report","status":"Draft: consultation closed","consultation_date":"2010-01-26 - 2010-04-30","first_published_date":"2010-01-26T02:00:00Z","last_updated_date":"2010-01-26T02:00:00Z","reference_number":"EMA/299895/2009","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-road-map-2015-agencys-contribution-science-medicines-health_en.pdf"},
    {"id":"23768","name":"Concept paper for the revision on the guideline for the conduct of pharmacokinetic studies in target animal species","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-03 - 2016-04-30","first_published_date":"2016-02-03T13:00:00Z","last_updated_date":"2016-02-03T13:00:00Z","reference_number":"EMA/CVMP/EWP/706701/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-conduct-pharmacokinetic-studies-target-animal-species_en.pdf"},
    {"id":"23800","name":"Concept paper on the need for revision of the points to consider on the clinical investigation of medicinal products other than nsaids in rheumatoid arthritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-01-20 - 2010-04-30","first_published_date":"2010-02-01T02:00:00Z","last_updated_date":"2010-02-01T02:00:00Z","reference_number":"EMA/CHMP/EWP/751552/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-points-consider-clinical-investigation-medicinal-products-other-nsaids-rheumatoid-arthritis_en.pdf"},
    {"id":"23855","name":"ICH guideline Q4B: Annex 13 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density and Tapped Density of Powders – General Chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-24 - 2010-12-01","first_published_date":"2010-09-24T04:00:00Z","last_updated_date":"2010-09-24T04:00:00Z","reference_number":"EMA/CHMP/ICH/405290/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q4b-annex-13-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-bulk-density-and-tapped-density-powders-general-chapter-step-3_en.pdf"},
    {"id":"23868","name":"Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-01 - 2014-10-31","first_published_date":"2014-10-01T17:40:00Z","last_updated_date":"2014-10-01T17:40:00Z","reference_number":"EMA/CHMP/BPWP/1625/1999 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-human-plasma-derived-and-recombinant-coagulation-factor-ix-products-revision-2_en.pdf"},
    {"id":"23908","name":"Draft Community herbal monograph on Echinaceae angustifolia DC., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-08-15","first_published_date":"2011-04-13T04:00:00Z","last_updated_date":"2011-04-13T04:00:00Z","reference_number":"EMA/HMPC/688216/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-echinaceae-angustifolia-dc-radix_en.pdf"},
    {"id":"23989","name":"Draft Community herbal monograph on Rhodiola rosea - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-08-15 - 2011-12-15","first_published_date":"2011-09-20T04:00:00Z","last_updated_date":"2011-09-20T04:00:00Z","reference_number":"EMA/HMPC/232091/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-rhodiola-rosea-first-version_en.pdf"},
    {"id":"24002","name":"Reflection paper on use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-12-17 - 2013-06-30","first_published_date":"2012-12-17T18:00:00Z","last_updated_date":"2012-12-17T18:00:00Z","reference_number":"EMA/CVMP/SAGAM/119489/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-use-pleuromutilins-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"24123","name":"Draft inventory of paediatric therapeutic needs: Paediatric oncology","type":"other","status":"Draft: consultation closed","consultation_date":"2014-10-07 - 2014-11-30","first_published_date":"2014-10-08T16:05:00Z","last_updated_date":"2014-10-08T16:05:00Z","reference_number":"EMA/PDCO/381728/2014","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-therapeutic-needs-paediatric-oncology_en.pdf"},
    {"id":"24150","name":"Call for scientific data for the systematic review of the monograph on Pimpinella anisum L., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558972/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-pimpinella-anisum-l-aetheroleum_en.pdf"},
    {"id":"24196","name":"Concept paper on the need for an addendum on the clinical investigation of medicinal products intended for treatment of glucocorticoid-induced osteoporosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-01-20 - 2010-04-30","first_published_date":"2010-01-29T02:00:00Z","last_updated_date":"2010-01-29T02:00:00Z","reference_number":"EMA/CHMP/EWP/15912/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-addendum-clinical-investigation-medicinal-products-intended-treatment-glucocorticoid-induced-osteoporosis_en.pdf"},
    {"id":"24262","name":"Draft Community herbal monograph on Cichorium intybus L., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-05-22 - 2012-10-15","first_published_date":"2012-06-15T15:00:00Z","last_updated_date":"2012-06-15T15:00:00Z","reference_number":"EMA/HMPC/121816/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cichorium-intybus-l-radix_en.pdf"},
    {"id":"24315","name":"Draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-01-20 - 2010-07-31","first_published_date":"2010-02-10T02:00:00Z","last_updated_date":"2010-02-10T02:00:00Z","reference_number":"CPMP/EWP/1080/00","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-diabetes-mellitus-revision-1_en.pdf"},
    {"id":"24365","name":"Concept paper on the revision of the guideline on specifications: Test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-01 - 2015-08-31","first_published_date":"2015-06-01T20:00:00Z","last_updated_date":"2015-06-01T20:00:00Z","reference_number":"EMA/HMPC/217753/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-specifications-test-procedures-and-acceptance-criteria-herbal-substances-herbal-preparations-and-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"24379","name":"Concept paper on the revision of the CVMP guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-04-07 - 2011-07-31","first_published_date":"2011-04-20T04:00:00Z","last_updated_date":"2011-04-20T04:00:00Z","reference_number":"EMA/CVMP/EWP/760764/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-cvmp-guideline-demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances_en.pdf"},
    {"id":"24421","name":"Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T21:18:12Z","last_updated_date":"2012-06-25T21:18:12Z","reference_number":"EMA/873138/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-vi-management-and-reporting-adverse-reactions-medicinal-products-superseded_en.pdf"},
    {"id":"24518","name":"Draft list of references supporting the assessment of Arctostaphylos uvae ursi (L.) Spreng, folium","type":"herbal-references","status":"Draft","consultation_date":"2010-08-15 - 2010-12-15","first_published_date":"2010-08-18T04:00:00Z","last_updated_date":"2010-08-18T04:00:00Z","reference_number":"EMA/HMPC/573461/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-arctostaphylos-uvae-ursi-l-spreng-folium_en.pdf"},
    {"id":"24527","name":"Draft guideline on adjustment for baseline covariates","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-28 - 2013-12-31","first_published_date":"2013-06-28T18:50:00Z","last_updated_date":"2013-06-28T18:50:00Z","reference_number":"EMA/295050/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-adjustment-baseline-covariates_en.pdf"},
    {"id":"24589","name":"Questions and answers on Ethanol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-24 - 2014-05-31","first_published_date":"2014-02-24T12:00:00Z","last_updated_date":"2014-02-24T12:00:00Z","reference_number":"EMA/CHMP/507988/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-ethanol-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"24615","name":"Call for scientific data for the periodic review of the monograph on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria L.), flos - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/248310/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-filipendula-ulmaria-l-maxim-spiraea-ulmaria-l-flos-first-version_en.pdf"},
    {"id":"24619","name":"Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-05-08 - 2014-07-14","first_published_date":"2014-05-08T18:00:00Z","last_updated_date":"2014-05-08T18:00:00Z","reference_number":"EMA/109608/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-best-practice-guidance-pilot-european-medicines-agency-health-technology-assessment-parallel-scientific-advice-procedures_en.pdf"},
    {"id":"24649","name":"Call for scientific data for use in HMPC assessment work on Artemisia absinthium L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-07-23 - 2014-10-31","first_published_date":"2014-07-24T18:30:00Z","last_updated_date":"2014-07-24T18:30:00Z","reference_number":"EMA/HMPC/447912/2014 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-artemisia-absinthium-l-herba_en.pdf"},
    {"id":"24673","name":"Draft guideline on good pharmacovigilance practices: Module VII – Periodic safety update report (Rev 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-25 - 2013-06-25","first_published_date":"2013-04-25T14:00:00Z","last_updated_date":"2013-04-25T14:00:00Z","reference_number":"EMA/816292/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-vii-periodic-safety-update-report-rev-1_en.pdf"},
    {"id":"24733","name":"Draft guideline on core SmPC and package leaflet for fluorodopa (18F)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-06-01 - 2016-09-30","first_published_date":"2016-06-01T18:00:01Z","last_updated_date":"2016-06-01T18:00:01Z","reference_number":"EMA/CHMP/337958/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-fluorodopa-18f_en.pdf"},
    {"id":"24809","name":"Draft rivaroxaban film-coated tablets 2.5, 10, 15 and 20mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-01 - 2016-01-01","first_published_date":"2015-10-06T17:00:00Z","last_updated_date":"2015-10-06T17:00:00Z","reference_number":"EMA/CHMP/PKWP/151340/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-rivaroxaban-film-coated-tablets-25-10-15-and-20mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"24914","name":"Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-05-31","first_published_date":"2011-12-22T12:20:00Z","last_updated_date":"2011-12-22T12:20:00Z","reference_number":"EMA/CHMP/27994/2008 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/appendix-1-guideline-evaluation-anticancer-medicinal-products-man_en.pdf"},
    {"id":"24916","name":"Draft concept paper on review and update of European Medicines Agency guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-07 - 2014-05-31","first_published_date":"2014-02-07T18:00:00Z","last_updated_date":"2014-02-07T18:00:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/704685/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-review-and-update-european-medicines-agency-guidelines-implement-best-practice-regard-3rs-replacement-reduction-and-refinement-regulatory-testing-medicinal-products_en.pdf"},
    {"id":"24917","name":"Concept paper for the revision of the guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-26 - 2018-02-28","first_published_date":"2018-01-26T19:30:00Z","last_updated_date":"2018-01-26T19:30:00Z","reference_number":"EMA/CVMP/SWP/779037/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-safety-and-residue-data-requirements-pharmaceutical-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market_en.pdf"},
    {"id":"24938","name":"Draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2012-10-25 - 2013-02-15","first_published_date":"2012-10-25T13:22:00Z","last_updated_date":"2012-10-25T13:22:00Z","reference_number":"EMA/HMPC/893108/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids_en.pdf"},
    {"id":"24956","name":"Call for scientific data for the systematic review of the monograph on Achillea millefolium L., flos and Achillea millefolium L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/844909/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-achillea-millefolium-l-flos-and-achillea-millefolium-l-herba_en.pdf"},
    {"id":"24984","name":"Draft public statement on Citrus bergamia Risso et Poiteau, aetheroleum","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-19T20:30:10Z","last_updated_date":"2011-10-19T20:30:10Z","reference_number":"EMA/HMPC/528177/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-citrus-bergamia-risso-et-poiteau-aetheroleum_en.pdf"},
    {"id":"25016","name":"Concept paper on clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-01 - 2015-06-30","first_published_date":"2015-04-01T18:33:00Z","last_updated_date":"2015-04-01T18:33:00Z","reference_number":"EMA/CHMP/80184/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-clinical-investigation-medicinal-products-treatment-axial-spondyloarthritis-revision-1_en.pdf"},
    {"id":"25039","name":"Public statement on the use of herbal medicinal products containing estragole","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2014-12-22 - 2015-03-31","first_published_date":"2014-12-22T12:30:00Z","last_updated_date":"2014-12-22T12:30:00Z","reference_number":"EMA/HMPC/137212/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-use-herbal-medicinal-products-containing-estragole_en.pdf"},
    {"id":"25054","name":"Call for scientific data for the systematic review of the monograph on Centaurium erythraea Rafn., herba.","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-12-12 - 2015-03-15","first_published_date":"2014-12-15T13:40:00Z","last_updated_date":"2014-12-15T13:40:00Z","reference_number":"EMA/HMPC/776606/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-centaurium-erythraea-rafn-herba_en.pdf"},
    {"id":"25071","name":"Draft guideline on clinical investigation of medicinal products for the treatment of chronic heart failure  - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-11 - 2016-08-31","first_published_date":"2016-02-11T11:40:00Z","last_updated_date":"2016-02-11T11:40:00Z","reference_number":"EMA/CHMP/392958/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-chronic-heart-failure-revision-2_en.pdf"},
    {"id":"25083","name":"Draft concept paper on the need to revise the \"Guideline on the evaluation of anticancer medicinal products in man\" in order to provide guidance on the reporting of safety data from clinical trials - Revision 5","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-05-01 - 2015-07-31","first_published_date":"2015-04-30T15:00:00Z","last_updated_date":"2015-04-30T15:00:00Z","reference_number":"EMA/130525/2015 Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revise-guideline-evaluation-anticancer-medicinal-products-man-order-provide-guidance-reporting-safety-data-clinical-trials-revision-5_en.pdf"},
    {"id":"25101","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-11-18 - 2017-02-28","first_published_date":"2016-11-18T10:30:00Z","last_updated_date":"2016-11-18T10:30:00Z","reference_number":"EMA/CHMP/183826/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-depression-revision-3_en.pdf"},
    {"id":"25118","name":"Draft concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-03 - 2013-09-01","first_published_date":"2013-06-03T14:00:00Z","last_updated_date":"2013-06-03T14:00:00Z","reference_number":"EMA/CHMP/281099/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-venous-thromboembolic-disease_en.pdf"},
    {"id":"25119","name":"Call for scientific data for the systematic review of the monograph on Avena sativa L., herba and Avena sativa L., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-06-15 - 2016-09-15","first_published_date":"2016-06-15T13:00:00Z","last_updated_date":"2016-06-15T13:00:00Z","reference_number":"EMA/HMPC/403693/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-avena-sativa-l-herba-and-avena-sativa-l-fructus_en.pdf"},
    {"id":"25163","name":"Draft Community herbal monograph on Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-09-13 - 2012-02-15","first_published_date":"2011-10-20T04:00:00Z","last_updated_date":"2011-10-20T04:00:00Z","reference_number":"EMA/HMPC/337066/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-tilia-cordata-miller-tilia-platyphyllos-scop-tilia-x-vulgaris-heyne-or-their-mixtures-flos-first-version_en.pdf"},
    {"id":"25202","name":"Concept paper on the revision of the guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant granulocyte-colony stimulating factor","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-27 - 2015-10-31","first_published_date":"2015-07-27T20:00:00Z","last_updated_date":"2015-07-27T20:00:00Z","reference_number":"EMA/CHMP/BMWP/214262/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-granulocyte-colony-stimulating-factor_en.pdf"},
    {"id":"25221","name":"Draft questions and answers on post approval change management protocols","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-10-14 - 2011-02-28","first_published_date":"2010-11-04T02:00:00Z","last_updated_date":"2010-11-04T02:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/586330/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-post-approval-change-management-protocols_en.pdf"},
    {"id":"25243","name":"Concept paper on good genomics biomarker practices - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-08-04 - 2014-11-04","first_published_date":"2014-08-04T15:00:00Z","last_updated_date":"2014-08-04T15:00:00Z","reference_number":"EMA/CHMP/PGWP/415990/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-good-genomics-biomarker-practices-first-version_en.pdf"},
    {"id":"25298","name":"Draft guideline on medicinal products for the treatment of insomnia","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-22 - 2010-04-30","first_published_date":"2009-11-12T01:09:00Z","last_updated_date":"2009-11-12T01:09:00Z","reference_number":"EMEA/16274/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-medicinal-products-treatment-insomnia_en.pdf"},
    {"id":"25347","name":"Draft public statement on Paeonia lactiflora Pallas, radix (Paeoniae radix alba)","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2016-02-16 - 2016-05-15","first_published_date":"2016-02-16T17:10:00Z","last_updated_date":"2016-02-16T17:10:00Z","reference_number":"EMA/HMPC/150787/2015","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-paeonia-lactiflora-pallas-radix-paeoniae-radix-alba_en.pdf"},
    {"id":"25358","name":"Call for scientific data for the systematic review of the monograph on Trigonella foenum-graecum L., semen","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-07-15 - 2016-10-15","first_published_date":"2016-07-15T13:00:00Z","last_updated_date":"2016-07-15T13:00:00Z","reference_number":"EMA/HMPC/403792/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-trigonella-foenum-graecum-l-semen_en.pdf"},
    {"id":"25377","name":"Draft Fingolimod capsules 0.5mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-02 - 2016-07-31","first_published_date":"2016-05-02T13:00:00Z","last_updated_date":"2016-05-02T13:00:00Z","reference_number":"EMA/CHMP/154812/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-fingolimod-capsules-05mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"25437","name":"Draft guideline on epidemiological data on blood transmissible infections","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-01 - 2015-08-31","first_published_date":"2015-06-02T13:00:00Z","last_updated_date":"2015-06-02T13:00:00Z","reference_number":"EMA/CHMP/BWP/548524/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-epidemiological-data-blood-transmissible-infections_en.pdf"},
    {"id":"25439","name":"Second draft guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-01-15","first_published_date":"2013-11-15T11:30:00Z","last_updated_date":"2013-11-15T11:30:00Z","reference_number":"EMA/CHMP/623942/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/second-draft-guideline-clinical-investigation-medicinal-products-prevention-stroke-and-systemic-embolic-events-patients-non-valvular-atrial-fibrillation_en.pdf"},
    {"id":"25486","name":"Draft paediatric addendum to the note for guidance on the clinical investigation on medicinal products in the treatment of hypertension","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-09-30 - 2014-03-31","first_published_date":"2013-09-30T13:30:00Z","last_updated_date":"2013-09-30T13:30:00Z","reference_number":"EMA/CHMP/206815/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paediatric-addendum-note-guidance-clinical-investigation-medicinal-products-treatment-hypertension_en.pdf"},
    {"id":"25501","name":"Qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for the use of cerebrospinal-fluid amyloid beta 1-42 and t-tau signature and / or positron-emission-tomography amyloid imaging (positive / neg...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2011-11-17 - 2011-12-22","first_published_date":"2011-12-02T16:30:00Z","last_updated_date":"2011-12-02T16:30:00Z","reference_number":"EMA/CHMP/SAWP/893622/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-alzheimers-disease-novel-methodologies-biomarkers-use-cerebrospinal-fluid-amyloid-beta-1-42-and-t-tau-signature-and-or-positron-emission-tomography-amyloid-imaging-positive-neg_en.pdf"},
    {"id":"25619","name":"Draft guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-01-30 - 2014-07-30","first_published_date":"2014-01-30T16:00:00Z","last_updated_date":"2014-01-30T16:00:00Z","reference_number":"EMA/281371/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-key-aspects-use-pharmacogenomic-methodologies-pharmacovigilance-evaluation-medicinal-products_en.pdf"},
    {"id":"25677","name":"Draft assessment report on Euphrasia officinalis L. and Euphrasia rostkoviana Hayne, herba","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2010-01-15 - 2010-04-15","first_published_date":"2010-02-12T01:09:21Z","last_updated_date":"2010-02-12T01:09:21Z","reference_number":"EMA/HMPC/246799/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-euphrasia-officinalis-l-and-euphrasia-rostkoviana-hayne-herba_en.pdf"},
    {"id":"25712","name":"Draft guideline on the plant testing strategy for veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-27 - 2016-11-30","first_published_date":"2016-05-27T20:00:00Z","last_updated_date":"2016-05-27T20:00:00Z","reference_number":"EMA/CVMP/ERA/689041/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-plant-testing-strategy-veterinary-medicinal-products_en.pdf"},
    {"id":"25801","name":"Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-31 - 2018-02-28","first_published_date":"2017-08-31T13:10:00Z","last_updated_date":"2017-08-31T13:10:00Z","reference_number":"EMA/CHMP/ICH/544278/1998","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-s5-r3-guideline-reproductive-toxicology-detection-toxicity-reproduction-human-pharmaceuticals-step-2b-revision-3_en.pdf"},
    {"id":"25812","name":"List of references supporting the assessment of Oenothera biennis L.; Oenothera lamarckiana L., oleum - First version","type":"herbal-references","status":"Draft","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-07-14T04:00:00Z","last_updated_date":"2011-07-14T04:00:00Z","reference_number":"EMA/HMPC/277817/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/list-references-supporting-assessment-oenothera-biennis-l-oenothera-lamarckiana-l-oleum-first-version_en.pdf"},
    {"id":"25818","name":"Draft concept paper on revision of annex 15 of the good-manufacturing-practice guide","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-27 - 2013-02-28","first_published_date":"2012-11-27T10:40:00Z","last_updated_date":"2012-11-27T10:40:00Z","reference_number":"EMA/INS/GMP/705397/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-annex-15-good-manufacturing-practice-guide_en.pdf"},
    {"id":"25838","name":"Concept paper on the need for a guideline on the clinical development of thrombopoetin receptor agonists for the treatment of chronic immune (idiopathic) thrombocytopenic purpura","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-08-31","first_published_date":"2010-06-03T04:00:00Z","last_updated_date":"2010-06-03T04:00:00Z","reference_number":"EMA/CHMP/EWP/203111/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-development-thrombopoetin-receptor-agonists-treatment-chronic-immune-idiopathic-thrombocytopenic-purpura_en.pdf"},
    {"id":"25883","name":"Draft guideline on clinical investigation of medicinal products for the treatment of multiple sclerosis - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-10-09 - 2013-04-09","first_published_date":"2012-10-09T17:59:00Z","last_updated_date":"2012-10-09T17:59:00Z","reference_number":"EMA/CHMP/771815/2011, Rev 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-multiple-sclerosis-revision-2_en.pdf"},
    {"id":"25938","name":"Draft concept paper on the revision of chapter 6 of the EU GMP guide quality control","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-01 - 2011-02-28","first_published_date":"2010-11-23T02:00:00Z","last_updated_date":"2010-11-23T02:00:00Z","reference_number":"EMA/INS/GMP/632654/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-concept-paper-revision-chapter-6-eu-gmp-guide-quality-control_en.pdf"},
    {"id":"25955","name":"Draft Community herbal monograph on Crataegus spp., folium cum flore","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-10-14 - 2015-01-15","first_published_date":"2014-10-14T04:00:00Z","last_updated_date":"2014-10-14T04:00:00Z","reference_number":"EMA/HMPC/159075/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"26000","name":"Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-04-15","first_published_date":"2012-10-15T13:15:00Z","last_updated_date":"2012-10-15T13:15:00Z","reference_number":"CHMP/EWP/2986/03 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure-revision-1_en.pdf"},
    {"id":"26055","name":"Call for scientific data for use in HMPC assessment work on Potenilla erecta (L.) Raeusch., rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/188907/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-potenilla-erecta-l-raeusch-rhizoma_en.pdf"},
    {"id":"26091","name":"Draft guideline on clinical investigation of medicinal products in the treatment of Chronic Obstructive Pulmonary Disease (COPD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-07-22 - 2011-03-01","first_published_date":"2010-09-20T04:00:00Z","last_updated_date":"2010-09-20T04:00:00Z","reference_number":"CPMP/EWP/562/98 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-chronic-obstructive-pulmonary-disease-copd_en.pdf"},
    {"id":"26144","name":"Draft Community herbal monograph on Levisticum officinale Koch, radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-03-27 - 2012-08-15","first_published_date":"2012-05-03T17:41:00Z","last_updated_date":"2012-05-03T17:41:00Z","reference_number":"EMA/HMPC/524621/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-levisticum-officinale-koch-radix_en.pdf"},
    {"id":"26162","name":"Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-15 - 2013-01-15","first_published_date":"2011-11-29T17:00:00Z","last_updated_date":"2012-11-19T12:30:00Z","reference_number":"EMA/CVMP/IWP/594618/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-combined-vaccines-and-associations-immunological-veterinary-medicinal-products-ivmps_en.pdf"},
    {"id":"26175","name":"Draft public statement on Myroxylon balsamum (L.) Harms var. pereirae (Royle) Harms, balsamum","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2015-12-11 - 2016-03-15","first_published_date":"2015-12-11T13:55:01Z","last_updated_date":"2015-12-11T13:55:01Z","reference_number":"EMA/HMPC/712649/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-myroxylon-balsamum-l-harms-var-pereirae-royle-harms-balsamum_en.pdf"},
    {"id":"26189","name":"Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘nervous tensions and to aid sleep’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2017-02-28 - 2017-05-31","first_published_date":"2017-03-06T16:00:00Z","last_updated_date":"2017-03-06T16:00:00Z","reference_number":"EMA/HMPC/133347/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-herbal-tea-combinations-traditionally-used-therapeutic-area-nervous-tensions-and-aid-sleep_en.pdf"},
    {"id":"26216","name":"Draft vemurafenib film-coated tablets 240 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-10-31","first_published_date":"2016-08-01T17:00:00Z","last_updated_date":"2016-08-01T17:00:00Z","reference_number":"EMA/CHMP/476248/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vemurafenib-film-coated-tablets-240-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"26240","name":"Draft implementation strategy of ICH Q3D guideline","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-12 - 2016-08-12","first_published_date":"2016-07-12T14:35:00Z","last_updated_date":"2016-07-12T14:35:00Z","reference_number":"EMA/404489/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-implementation-strategy-ich-q3d-guideline_en.pdf"},
    {"id":"26259","name":"Draft Community herbal monograph on Curcuma xanthorrhiza roxb., rhizoma","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-06-19 - 2013-09-15","first_published_date":"2013-06-19T04:00:00Z","last_updated_date":"2013-06-19T04:00:00Z","reference_number":"EMA/HMPC/604600/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-curcuma-xanthorrhiza-roxb-rhizoma_en.pdf"},
    {"id":"26284","name":"Draft oseltamivir product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423665/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-oseltamivir-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"26326","name":"Inventory of paediatric medicines - Cardiovascular therapeutic area","type":"other","status":"Adopted","consultation_date":"2012-08-30 - 2012-10-30","first_published_date":"2013-04-25T15:10:00Z","last_updated_date":"2013-04-25T15:10:00Z","reference_number":"EMA/PDCO/246339/2013","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-medicines-cardiovascular-therapeutic-area_en.pdf"},
    {"id":"26331","name":"Reflection paper on the risk of antimicrobial resistance transfer from companion animals","type":"scientific-guideline","status":"Adopted","consultation_date":"2015-01-27 - 2015-04-30","first_published_date":"2015-01-30T02:00:00Z","last_updated_date":"2015-01-30T02:00:00Z","reference_number":"EMA/CVMP/AWP/401740/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-antimicrobial-resistance-transfer-companion-animals_en.pdf"},
    {"id":"26403","name":"Draft Community herbal monograph on Cucurbita pepo L., semen","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-09-01 - 2012-02-15","first_published_date":"2011-10-17T04:00:00Z","last_updated_date":"2011-10-17T04:00:00Z","reference_number":"EMA/HMPC/136024/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"26425","name":"Draft European Union list entry on Valeriana officinalis L., radix","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-31","first_published_date":"2015-07-23T20:15:00Z","last_updated_date":"2015-07-23T20:15:00Z","reference_number":"EMA/HMPC/150849/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-european-union-list-entry-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"26467","name":"Concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products in man - Revision 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-07-22 - 2011-01-01","first_published_date":"2010-09-17T04:00:00Z","last_updated_date":"2010-09-17T04:00:00Z","reference_number":"EMA/CHMP/EWP/433478/2010 Rev. 4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-guideline-evaluation-anticancer-medicinal-products-man-revision-4_en.pdf"},
    {"id":"26495","name":"Concept paper on the guidance on the non-clinical and clinical development of medicinal products for HIV prevention including oral and topical PrEP","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-17 - 2011-04-30","first_published_date":"2011-02-24T02:00:00Z","last_updated_date":"2011-02-24T02:00:00Z","reference_number":"EMA/86004/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guidance-non-clinical-and-clinical-development-medicinal-products-hiv-prevention-including-oral-and-topical-prep_en.pdf"},
    {"id":"26518","name":"Draft guideline on quality of oral modified-release products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-09-15 - 2013-03-15","first_published_date":"2012-09-14T14:00:00Z","last_updated_date":"2012-09-14T14:00:00Z","reference_number":"EMA/492713/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-oral-modified-release-products_en.pdf"},
    {"id":"26521","name":"Draft concept paper on storage conditions during transport","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-01 - 2011-02-28","first_published_date":"2010-11-23T02:00:00Z","last_updated_date":"2010-11-23T02:00:00Z","reference_number":"EMA/INS/GMP/638479/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-concept-paper-storage-conditions-during-transport_en.pdf"},
    {"id":"26550","name":"Call for scientific data for use in HMPC assessment work on Vaccinium macrocarpon Aiton, fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669366/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-vaccinium-macrocarpon-aiton-fructus_en.pdf"},
    {"id":"26600","name":"Concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-14 - 2013-02-15","first_published_date":"2012-10-31T19:00:00Z","last_updated_date":"2012-11-14T11:55:00Z","reference_number":"EMA/CHMP/396984/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-development-new-medicinal-products-treatment-crohns-disease_en.pdf"},
    {"id":"26710","name":"Concept paper on the need of a guideline for clinical investigation of medicinal products for the treatment of chronic constipation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-14 - 2013-02-15","first_published_date":"2012-11-08T12:00:00Z","last_updated_date":"2012-11-14T11:57:00Z","reference_number":"EMA/CHMP/462198/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-investigation-medicinal-products-treatment-chronic-constipation_en.pdf"},
    {"id":"26723","name":"Draft good practice guide on risk minimisation and prevention of medication errors","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-14 - 2015-06-14","first_published_date":"2015-04-14T18:00:00Z","last_updated_date":"2015-04-14T18:00:00Z","reference_number":"EMA/606103/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-good-practice-guide-risk-minimisation-and-prevention-medication-errors_en.pdf"},
    {"id":"26746","name":"Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-12 - 2015-09-30","first_published_date":"2015-06-12T14:00:00Z","last_updated_date":"2015-06-12T14:00:00Z","reference_number":"EMA/CHMP/50549/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-assessment-cardiovascular-risk-medicinal-products-treatment-cardiovascular-and-metabolic-diseases_en.pdf"},
    {"id":"26783","name":"Draft template for the Qualified Person’s (QP's) declaration concerning good-manufacturing-practice compliance of the active substance used as starting material and verification of its supply chain “the QP declaration te...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-12-16 - 2011-04-30","first_published_date":"2011-01-13T02:00:00Z","last_updated_date":"2011-06-20T04:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/696270/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-template-qualified-persons-qps-declaration-concerning-good-manufacturing-practice-compliance-active-substance-used-starting-material-and-verification-its-supply-chain-qp-declaration-te_en.pdf"},
    {"id":"26830","name":"Draft European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-08-04 - 2017-11-04","first_published_date":"2017-08-04T19:30:00Z","last_updated_date":"2017-08-04T19:30:00Z","reference_number":"EMA/HMPC/48745/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-cimicifuga-racemosa-l-nutt-rhizome-revision-1_en.pdf"},
    {"id":"26900","name":"Draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-01 - 2015-09-30","first_published_date":"2015-07-01T13:19:00Z","last_updated_date":"2015-07-01T13:19:00Z","reference_number":"EMA/CHMP/BWP/723009/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-viral-safety-plasma-derived-medicinal-products-respect-hepatitis-e-virus_en.pdf"},
    {"id":"26909","name":"Draft guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-04 - 2015-08-31","first_published_date":"2015-03-04T17:00:00Z","last_updated_date":"2015-03-04T17:00:00Z","reference_number":"EMA/CVMP/AWP/706442/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-assessment-risk-public-health-antimicrobial-resistance-due-use-antimicrobial-veterinary-medicinal-product-food-producing-animals_en.pdf"},
    {"id":"26965","name":"Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR)","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T04:00:00Z","last_updated_date":"2013-04-25T14:00:00Z","reference_number":"EMA/170043/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-annex-ii-templates-cover-page-periodic-safety-update-report-psur_en.pdf"},
    {"id":"27001","name":"Draft guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus, cutaneous lupus and lupus nephritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-05 - 2013-09-04","first_published_date":"2013-03-05T19:00:00Z","last_updated_date":"2013-03-05T19:00:00Z","reference_number":"EMA/CHMP/51230/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-systemic-lupus-erythematosus-cutaneous-lupus-and-lupus-nephritis_en.pdf"},
    {"id":"27005","name":"Draft guideline on core summary of product characteristics for human fibrinogen products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-03-04 - 2014-06-04","first_published_date":"2014-03-04T14:00:00Z","last_updated_date":"2014-03-04T14:00:00Z","reference_number":"EMA/CHMP/BPWP/691754/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-product-characteristics-human-fibrinogen-products_en.pdf"},
    {"id":"27078","name":"Call for scientific data for use in HMPC assessment work on Calendulae herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-14T02:00:00Z","last_updated_date":"2014-02-14T02:00:00Z","reference_number":"EMA/HMPC/84830/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-calendulae-herba_en.pdf"},
    {"id":"27083","name":"Draft reflection paper on injection-site residues: considerations for risk assessment and residue surveillance (revision 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-10-18 - 2014-04-30","first_published_date":"2013-10-18T19:00:00Z","last_updated_date":"2013-10-18T19:00:00Z","reference_number":"EMA/CVMP/520190/2007-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-injection-site-residues-considerations-risk-assessment-and-residue-surveillance-revision-1_en.pdf"},
    {"id":"27090","name":"Guideline on the approach to establish a pharmacological acceptable daily intake","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-01-10 - 2012-07-31","first_published_date":"2012-01-23T12:30:00Z","last_updated_date":"2012-11-19T12:30:00Z","reference_number":"EMA/CVMP/SWP/355689/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-approach-establish-pharmacological-acceptable-daily-intake_en.pdf"},
    {"id":"27113","name":"Concept paper on assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-19 - 2013-06-30","first_published_date":"2013-04-19T13:31:02Z","last_updated_date":"2013-04-19T13:31:02Z","reference_number":"EMA/CVMP/ERA/718229/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-assessing-toxicological-risk-humans-and-environment-veterinary-pharmaceuticals-groundwater_en.pdf"},
    {"id":"27129","name":"Draft guideline on similar biological medicinal products containing interferon beta","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-05-31","first_published_date":"2012-01-19T11:32:00Z","last_updated_date":"2012-01-19T11:32:00Z","reference_number":"EMA/CHMP/BMWP/652000/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-biological-medicinal-products-containing-interferon-beta_en.pdf"},
    {"id":"27130","name":"Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-07 - 2013-08-30","first_published_date":"2013-06-07T15:00:00Z","last_updated_date":"2013-06-07T15:00:00Z","reference_number":"CPMP/328/98 Revision 6","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf"},
    {"id":"27133","name":"Draft qualification opinion on the paediatric ulcerative colitis activity index (PUCAI)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-09-18 - 2015-10-26","first_published_date":"2015-09-18T16:00:00Z","last_updated_date":"2015-09-18T16:00:00Z","reference_number":"EMA/CHMP/SAWP/485560/2015","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-paediatric-ulcerative-colitis-activity-index-pucai_en.pdf"},
    {"id":"27168","name":"Call for scientific data for use in HMPC assessment work on Leonurus cardiaca L., herba – Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/131485/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-leonurus-cardiaca-l-herba-revision-1_en.pdf"},
    {"id":"27225","name":"Concept paper on revision of note for guidance for the determination of withdrawal periods for milk","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-12-09 - 2011-03-31","first_published_date":"2010-12-15T02:00:00Z","last_updated_date":"2010-12-15T02:00:00Z","reference_number":"EMA/CVMP/SWP/736014/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-note-guidance-determination-withdrawal-periods-milk_en.pdf"},
    {"id":"27305","name":"Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits with tracked changes","type":"scientific-guideline","status":"unknown","consultation_date":"2012-07-26 - 2012-09-21","first_published_date":"2012-12-13T18:00:00Z","last_updated_date":"2012-12-13T18:00:00Z","reference_number":"EMA/228028/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-iv-pharmacovigilance-audits-tracked-changes_en.pdf"},
    {"id":"27371","name":"Draft Community herbal monograph on Eschscholzia californica Cham., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-07-31 - 2014-10-31","first_published_date":"2014-07-31T21:15:00Z","last_updated_date":"2014-07-31T21:15:00Z","reference_number":"EMA/HMPC/680372/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-eschscholzia-californica-cham-herba_en.pdf"},
    {"id":"27405","name":"Draft public statement on Salvia officinalis L. Aetheroleum","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2009-11-12 - 2010-04-15","first_published_date":"2010-02-03T02:00:00Z","last_updated_date":"2010-02-03T02:00:00Z","reference_number":"EMA/HMPC/41843/2009","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-salvia-officinalis-l-aetheroleum_en.pdf"},
    {"id":"27425","name":"Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-11-20 - 2018-05-31","first_published_date":"2017-11-21T13:30:00Z","last_updated_date":"2017-11-21T13:30:00Z","reference_number":"EMEA/CVMP/EWP/133/1999 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-conduct-pharmacokinetic-studies-target-animal-species-revision-1_en.pdf"},
    {"id":"27436","name":"Draft guideline on core summary of products characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-24 - 2018-03-31","first_published_date":"2018-01-24T18:30:00Z","last_updated_date":"2018-01-24T18:30:00Z","reference_number":"EMA/CHMP/745358/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-summary-products-characteristics-smpc-and-package-leaflet-technetium-99mtc-macrosalb_en.pdf"},
    {"id":"27437","name":"Standard rhabdomyosarcoma paediatric investigation plan","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2013-02-21 - 2013-05-05","first_published_date":"2013-02-22T13:00:01Z","last_updated_date":"2013-02-22T13:00:01Z","reference_number":"EMA/555130/2012","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/standard-rhabdomyosarcoma-paediatric-investigation-plan_en.pdf"},
    {"id":"27484","name":"Draft guideline on the higher-tier testing of veterinary medicinal products to dung fauna","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-25 - 2017-01-31","first_published_date":"2016-07-25T18:45:00Z","last_updated_date":"2016-07-25T18:45:00Z","reference_number":"EMA/CVMP/ERA/409350/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-higher-tier-testing-veterinary-medicinal-products-dung-fauna_en.pdf"},
    {"id":"27521","name":"Draft reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population","type":"other","status":"Draft: consultation closed","consultation_date":"2011-01-18 - 2011-04-15","first_published_date":"2011-01-19T01:31:00Z","last_updated_date":"2011-01-19T01:31:00Z","reference_number":"EMA/HMPC/833398/2009","document_url":"https://www.ema.europa.eu/en/documents/other/draft-reflection-paper-necessity-initiatives-stimulate-conduct-clinical-studies-herbal-medicinal-products-paediatric-population_en.pdf"},
    {"id":"27626","name":"Public consultation concerning a request for CVMP opinion under Article 30(3) of Regulation (EC) No 726/2004 on the risk for the consumer resulting from the use of diethanolamine as an excipient in veterinary medicinal p...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-03-16 - 2018-05-14","first_published_date":"2018-03-16T17:30:00Z","last_updated_date":"2018-03-16T17:30:00Z","reference_number":"EMA/CVMP/157690/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/public-consultation-concerning-request-cvmp-opinion-under-article-303-regulation-ec-no-726-2004-risk-consumer-resulting-use-diethanolamine-excipient-veterinary-medicinal-p_en.pdf"},
    {"id":"27671","name":"Draft community list entry on Vitis vinifera var. Tinctoria L., folium","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2010-01-14 - 2010-05-15","first_published_date":"2010-02-12T02:09:21Z","last_updated_date":"2010-02-12T02:09:21Z","reference_number":"EMA/HMPC/5816/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-vitis-vinifera-var-tinctoria-l-folium_en.pdf"},
    {"id":"27693","name":"Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-20 - 2013-08-31","first_published_date":"2013-03-20T18:00:00Z","last_updated_date":"2013-03-20T18:00:00Z","reference_number":"EMA/CHMP/153191/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-intended-treatment-chronic-primary-immune-thrombocytopenia_en.pdf"},
    {"id":"27847","name":"Draft guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-02-29","first_published_date":"2015-12-15T13:30:00Z","last_updated_date":"2015-12-15T13:30:00Z","reference_number":"EMA/168402/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-product-or-population-specific-considerations-ii-biological-medicinal-products_en.pdf"},
    {"id":"27878","name":"Draft guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-14 - 2010-10-31","first_published_date":"2009-10-19T04:00:00Z","last_updated_date":"2010-07-19T04:00:00Z","reference_number":"EMA/CVMP/EWP/459868/2008-CONSULTATION","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-demonstration-target-animal-safety-and-efficacy-veterinary-medicinal-products-intended-use-farmed-finfish_en.pdf"},
    {"id":"28003","name":"Concept paper on the need for revision of the note for guidance on the clinical investigation of medicinal products for the treatment of cardiac failure - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-01 - 2013-05-31","first_published_date":"2013-03-01T12:00:00Z","last_updated_date":"2013-03-01T12:00:00Z","reference_number":"EMA/CHMP/87576/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-cardiac-failure-revision-1_en.pdf"},
    {"id":"28012","name":"Concept paper on the revision of the guideline on nonclinical and clinical development of  similar biological medicinal products containing low-molecular-weight heparins","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-07-21 - 2011-09-30","first_published_date":"2011-07-27T04:00:00Z","last_updated_date":"2011-07-27T04:00:00Z","reference_number":"EMA/CHMP/BMWP/522386/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-nonclinical-and-clinical-development-similar-biological-medicinal-products-containing-low-molecular-weight-heparins_en.pdf"},
    {"id":"28154","name":"Draft guideline on the chemistry of active substances (veterinary)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-02-13 - 2017-08-13","first_published_date":"2017-02-13T17:00:00Z","last_updated_date":"2017-02-13T17:00:00Z","reference_number":"EMA/CVMP/QWP/49477/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-chemistry-active-substances-veterinary_en.pdf"},
    {"id":"28188","name":"Draft Community herbal monograph on Paullinia cupana Kunth ex H.B.K. var. sorbilis (Mart.) Ducke, semen - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-06-15 - 2012-10-15","first_published_date":"2012-06-25T14:07:00Z","last_updated_date":"2012-06-25T14:07:00Z","reference_number":"EMA/HMPC/897344/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-paullinia-cupana-kunth-ex-hbk-var-sorbilis-mart-ducke-semen-first-version_en.pdf"},
    {"id":"28211","name":"Reflection paper on the non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-03-15 - 2012-06-30","first_published_date":"2012-03-15T13:54:29Z","last_updated_date":"2012-03-15T13:54:29Z","reference_number":"EMA/171264/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-non-clinical-and-clinical-development-oral-and-topical-hiv-pre-exposure-prophylaxis-prep_en.pdf"},
    {"id":"28258","name":"Draft guideline on clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-30 - 2018-01-31","first_published_date":"2017-10-30T14:30:00Z","last_updated_date":"2017-10-30T14:30:00Z","reference_number":"EMA/CHMP/BPWP/144533/2009 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-viii-products-revision-2_en.pdf"},
    {"id":"28300","name":"Concept paper on the update of guidance on the clinical development of medicinal products for the treatment of HIV","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-10-20 - 2012-01-31","first_published_date":"2011-11-15T15:00:00Z","last_updated_date":"2011-11-15T15:00:00Z","reference_number":"EMA/802793/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-update-guidance-clinical-development-medicinal-products-treatment-hiv_en.pdf"},
    {"id":"28324","name":"Draft guideline on clinical investigation of medicinal products in the treatment of diabetes mellitus (second and final release for public consultation) - Revision 1 (second release)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-16 - 2011-11-18","first_published_date":"2011-10-07T13:13:00Z","last_updated_date":"2011-10-07T13:13:00Z","reference_number":"CPMP/EWP/1080/00 Rev. 1*","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-diabetes-mellitus-second-and-final-release-public-consultation-revision-1-second-release_en.pdf"},
    {"id":"28351","name":"Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-01 - 2017-10-31","first_published_date":"2017-08-01T14:00:00Z","last_updated_date":"2018-02-20T12:00:00Z","reference_number":"EMA/CHMP/SWP/545959/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guidance-non-clinical-evaluation-radiopharmaceuticals-first-version_en.pdf"},
    {"id":"28377","name":"Call for scientific data for use in HMPC assessment work on Crataegus spp., folium cum flore","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-27T14:25:00Z","last_updated_date":"2011-10-27T14:25:00Z","reference_number":"EMA/HMPC/853777/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-crataegus-spp-folium-cum-flore_en.pdf"},
    {"id":"28389","name":"Concept paper on the need for revision of the points to consider on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-04-01 - 2012-06-30","first_published_date":"2012-03-30T13:00:00Z","last_updated_date":"2012-03-30T13:00:00Z","reference_number":"EMA/CHMP/59352/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-points-consider-clinical-investigation-medicinal-products-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"28420","name":"Draft European Union herbal monograph on Ribes nigrum L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-02-28 - 2017-06-01","first_published_date":"2017-02-28T11:24:00Z","last_updated_date":"2017-02-28T11:24:00Z","reference_number":"EMA/HMPC/745353/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-ribes-nigrum-l-folium_en.pdf"},
    {"id":"28430","name":"Draft M4E(R2) Common technical document for the registration of pharmaceuticals for human use – efficacy - Step 3","type":"scientific-guideline","status":"Adopted","consultation_date":"2015-10-07 - 2015-12-31","first_published_date":"2015-10-07T13:50:00Z","last_updated_date":"2016-07-28T19:00:00Z","reference_number":"EMA/CPMP/ICH/2887/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-m4er2-common-technical-document-registration-pharmaceuticals-human-use-efficacy-step-3_en.pdf"},
    {"id":"28489","name":"Draft cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-31 - 2018-04-30","first_published_date":"2018-01-31T14:15:00Z","last_updated_date":"2018-01-31T14:15:00Z","reference_number":"EMA/CHMP/800759/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-cholic-acid-capsules-50-mg-and-250-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"28565","name":"European Union herbal monograph on Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-04-09 - 2015-07-15","first_published_date":"2015-04-09T04:00:00Z","last_updated_date":"2015-04-09T04:00:00Z","reference_number":"EMA/HMPC/712511/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/european-union-herbal-monograph-epilobium-angustifolium-l-and-or-epilobium-parviflorum-schreb-herba_en.pdf"},
    {"id":"28703","name":"Draft public statement on Salvia fruticosa Mill., folium","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2015-12-09 - 2016-03-15","first_published_date":"2015-12-09T10:30:00Z","last_updated_date":"2015-12-09T10:30:00Z","reference_number":"EMA/HMPC/599993/2014","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-salvia-fruticosa-mill-folium_en.pdf"},
    {"id":"28737","name":"Draft guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev. 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-02-29","first_published_date":"2015-12-15T13:30:00Z","last_updated_date":"2015-12-15T13:30:00Z","reference_number":"EMA/118465/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-xv-safety-communication-rev-1_en.pdf"},
    {"id":"28771","name":"Draft guideline on good pharmacovigilance practices: Module XV – Safety communication","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-07-26 - 2012-09-21","first_published_date":"2012-07-26T20:15:01Z","last_updated_date":"2012-07-26T20:15:01Z","reference_number":"EMA/118465/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-xv-safety-communication_en.pdf"},
    {"id":"28862","name":"Draft note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products annex on non-clinical testing for inadvertent germline transmission of gene transfer vectors","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2005-11-01 - 2006-05-01","first_published_date":"2005-11-17T02:00:00Z","last_updated_date":"2005-11-17T02:00:00Z","reference_number":"EMEA/273974/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-note-guidance-quality-preclinical-and-clinical-aspects-gene-transfer-medicinal-products-annex-non-clinical-testing-inadvertent-germline-transmission-gene-transfer-vectors_en.pdf"},
    {"id":"28870","name":"Dossier submitted for qualification opinion - In vitro hollow-fibre-system model of tuberculosis (HFS-TB)","type":"other","status":"unknown","consultation_date":"2014-11-18 - 2015-01-09","first_published_date":"2014-11-18T16:00:00Z","last_updated_date":"2014-11-18T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/dossier-submitted-qualification-opinion-vitro-hollow-fibre-system-model-tuberculosis-hfs-tb_en.pdf"},
    {"id":"28888","name":"Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-11-30","first_published_date":"2010-06-18T04:00:00Z","last_updated_date":"2010-06-18T04:00:00Z","reference_number":"EMA/CHMP/GTWP/671639/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-non-clinical-and-clinical-aspects-medicinal-products-containing-genetically-modified-cells-first-version_en.pdf"},
    {"id":"28903","name":"Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-08-15 - 2018-11-30","first_published_date":"2018-08-15T20:00:00Z","last_updated_date":"2018-08-15T20:00:00Z","reference_number":"EMA/HMPC/201116/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-3_en.pdf"},
    {"id":"28907","name":"Call for scientific data for the systematic review of the monograph on Hedera helix L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-10-14 - 2016-01-15","first_published_date":"2015-10-14T14:00:00Z","last_updated_date":"2015-10-14T14:00:00Z","reference_number":"EMA/HMPC/669362/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-hedera-helix-l-folium_en.pdf"},
    {"id":"28913","name":"Draft guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-05-01 - 2014-10-31","first_published_date":"2014-04-30T14:00:00Z","last_updated_date":"2014-04-30T14:00:00Z","reference_number":"EMA/CHMP/BWP/187338/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-process-validation-manufacture-biotechnology-derived-active-substances-and-data-be-provided-regulatory-submission_en.pdf"},
    {"id":"28923","name":"Draft Community herbal monograph on Lavandula angustifolia Mill., aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-08-15","first_published_date":"2011-02-11T02:00:00Z","last_updated_date":"2011-06-16T04:00:00Z","reference_number":"EMA/HMPC/143181/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-lavandula-angustifolia-mill-aetheroleum_en.pdf"},
    {"id":"28936","name":"ICH guideline E18 on genomic sampling and management of genomic data - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-01 - 2016-05-31","first_published_date":"2016-02-01T16:56:00Z","last_updated_date":"2016-02-01T16:56:00Z","reference_number":"EMA/CHMP/ICH/11623/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e18-genomic-sampling-and-management-genomic-data-step-3_en.pdf"},
    {"id":"28951","name":"Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-08-01 - 2014-10-31","first_published_date":"2014-08-01T14:00:00Z","last_updated_date":"2014-08-01T14:00:00Z","reference_number":"EMA/CHMP/704219/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-wheat-starch-containing-gluten-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"28971","name":"Draft reflection paper on immune tolerance induction in haemophilia-A patients with inhibitors","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-07-30 - 2012-10-31","first_published_date":"2012-07-31T17:00:00Z","last_updated_date":"2012-07-31T17:00:00Z","reference_number":"EMA/CHMP/BPWP/153137/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-immune-tolerance-induction-haemophilia-patients-inhibitors_en.pdf"},
    {"id":"28972","name":"Draft community herbal monograph on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria (L.)), herba - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-01-15 - 2011-04-15","first_published_date":"2011-01-26T02:00:00Z","last_updated_date":"2011-01-26T02:00:00Z","reference_number":"EMA/HMPC/434881/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-filipendula-ulmaria-l-maxim-spiraea-ulmaria-l-herba-first-version_en.pdf"},
    {"id":"28999","name":"Draft reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-29 - 2016-10-31","first_published_date":"2016-04-29T18:25:00Z","last_updated_date":"2016-04-29T18:25:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/164002/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-providing-overview-current-regulatory-testing-requirements-veterinary-medicinal-products-and-opportunities-implementation-3rs_en.pdf"},
    {"id":"29050","name":"Draft memantine product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423734/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-memantine-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"29081","name":"Concept paper on the revision of guidelines for influenza vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2011-12-31","first_published_date":"2011-10-03T18:35:00Z","last_updated_date":"2011-10-03T18:35:00Z","reference_number":"EMA/CHMP/VWP/734330/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-influenza-vaccines_en.pdf"},
    {"id":"29111","name":"Revised concept paper on the need for revision of the position on the replacement of animal studies by in-vitro models","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-07-25 - 2012-09-28","first_published_date":"2012-07-25T14:40:00Z","last_updated_date":"2012-07-25T14:40:00Z","reference_number":"MA/CHMP/CVMP/JEG-3Rs/169839/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-concept-paper-need-revision-position-replacement-animal-studies-vitro-models_en.pdf"},
    {"id":"29236","name":"Draft guideline on the evaluation of drugs for the treatment of gastroesophageal reflux disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-17 - 2010-06-30","first_published_date":"2010-01-08T02:00:00Z","last_updated_date":"2010-01-08T02:00:00Z","reference_number":"EMEA/CHMP/EWP/342691/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-drugs-treatment-gastroesophageal-reflux-disease_en.pdf"},
    {"id":"29237","name":"Draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-27 - 2019-01-31","first_published_date":"2018-07-27T16:47:00Z","last_updated_date":"2018-07-27T16:47:00Z","reference_number":"EMA/CVMP/849775/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-dose-optimisation-established-veterinary-antibiotics-context-summary-product-characteristics-spc-harmonisation-first-version_en.pdf"},
    {"id":"29320","name":"Draft reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-01 - 2018-03-31","first_published_date":"2017-03-31T21:15:00Z","last_updated_date":"2017-03-31T21:15:00Z","reference_number":"EMA/CHMP/138502/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf"},
    {"id":"29323","name":"Draft reflection paper on clinical aspects related to tissue-engineered products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-04-17 - 2012-07-31","first_published_date":"2012-04-17T15:47:00Z","last_updated_date":"2012-04-17T15:47:00Z","reference_number":"EMA/CAT/CPWP/573420/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-clinical-aspects-related-tissue-engineered-products_en.pdf"},
    {"id":"29334","name":"Draft guideline on influenza vaccines – submission and procedural requirements","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-10-30 - 2015-01-30","first_published_date":"2014-10-30T13:00:00Z","last_updated_date":"2014-10-30T13:00:00Z","reference_number":"EMA/56793/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-influenza-vaccines-submission-and-procedural-requirements_en.pdf"},
    {"id":"29336","name":"ICH: E 7: Studies in support of special populations: Geriatrics: Questions and answers - Step 5","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-01 - 2010-01-31","first_published_date":"2009-09-01T04:00:00Z","last_updated_date":"2010-07-27T04:00:00Z","reference_number":"EMEA/CHMP/ICH/604661/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-7-studies-support-special-populations-geriatrics-questions-and-answers-step-5_en.pdf"},
    {"id":"29382","name":"Draft Community herbal monograph on Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch, radix - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-08-15 - 2011-11-15","first_published_date":"2011-08-19T04:00:00Z","last_updated_date":"2011-08-19T04:00:00Z","reference_number":"EMA/HMPC/571119/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-glycyrrhiza-glabra-l-and-or-glycyrrhiza-inflata-bat-and-or-glycyrrhiza-uralensis-fisch-radix-first-version_en.pdf"},
    {"id":"29435","name":"Call for scientific data for use in HMPC assessment work on Sambucus nigra L., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-10-15 - 2012-02-15","first_published_date":"2011-10-17T19:44:00Z","last_updated_date":"2011-10-17T19:44:00Z","reference_number":"EMA/HMPC/778979/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-sambucus-nigra-l-fructus_en.pdf"},
    {"id":"29447","name":"Draft guideline on good pharmacogenomic practice - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-02 - 2016-09-16","first_published_date":"2016-05-02T15:15:00Z","last_updated_date":"2016-05-02T15:15:00Z","reference_number":"EMA/CHMP/268544/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacogenomic-practice-first-version_en.pdf"},
    {"id":"29464","name":"Call for scientific data for the systematic review of the monograph on Melissa officinalis L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558979/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-melissa-officinalis-l-folium_en.pdf"},
    {"id":"29484","name":"Call for scientific data for the systematic review of the monograph on Hypericum perforatum L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-02-09 - 2015-05-15","first_published_date":"2015-02-09T12:45:00Z","last_updated_date":"2015-02-09T12:45:00Z","reference_number":"EMA/HMPC/79040/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-hypericum-perforatum-l-herba_en.pdf"},
    {"id":"29528","name":"Draft paracetamol oral use, immediate release formulations product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-28 - 2017-10-31","first_published_date":"2017-07-28T14:00:00Z","last_updated_date":"2017-07-28T14:00:00Z","reference_number":"EMA/CHMP/356877/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paracetamol-oral-use-immediate-release-formulations-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"29558","name":"Draft procedural advice on the submission of variations for annual update of human influenza-inactivated-vaccine applications in the centralised procedure - Revision 2 - Superseded","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-22 - 2013-04-05","first_published_date":"2013-03-22T17:00:00Z","last_updated_date":"2013-03-22T17:00:00Z","reference_number":"EMA/CHMP/BWP/99698/2007 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-procedural-advice-submission-variations-annual-update-human-influenza-inactivated-vaccine-applications-centralised-procedure-revision-2-superseded_en.pdf"},
    {"id":"29583","name":"Draft ICH guideline Q4B: Annex 14 to Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Tests – General Chapter - Step 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-24 - 2010-12-01","first_published_date":"2010-09-24T04:00:00Z","last_updated_date":"2010-09-24T04:00:00Z","reference_number":"EMA/CHMP/ICH/529785/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q4b-annex-14-note-evaluation-and-recommendation-pharmacopoeial-texts-use-ich-regions-bacterial-endotoxins-tests-general-chapter-step-3_en.pdf"},
    {"id":"29585","name":"Draft guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-01 - 2016-01-31","first_published_date":"2015-10-01T13:50:00Z","last_updated_date":"2015-10-01T13:50:00Z","reference_number":"EMEA/CHMP/BMWP/14327/2006 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-revision-1_en.pdf"},
    {"id":"29608","name":"Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2014-06-05 - 2014-07-27","first_published_date":"2014-06-05T21:00:00Z","last_updated_date":"2014-06-05T21:00:00Z","reference_number":"EMA/161530/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-detailed-guide-regarding-monitoring-medical-literature-and-entry-relevant-information-eudravigilance-database-european-medicines-agency_en.pdf"},
    {"id":"29654","name":"Call for scientific data for use in HMPC assessment work on Cisti cretici folium/resinum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-14T18:40:00Z","last_updated_date":"2014-02-14T18:40:00Z","reference_number":"EMA/HMPC/87605/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-cisti-cretici-folium-resinum_en.pdf"},
    {"id":"29777","name":"Draft guideline on core SmPC and package leaflet for (68Ge/68Ga) generator - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-06-01 - 2016-09-30","first_published_date":"2016-06-01T18:00:00Z","last_updated_date":"2016-06-01T18:00:00Z","reference_number":"EMA/CHMP/337681/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-68ge-68ga-generator-first-version_en.pdf"},
    {"id":"29816","name":"Qualification opinion of Alzheimer’s disease novel methodologies / biomarkers for positron-emission-tomograpy amyloid imaging (positive / negative) as a biomarker for enrichment for use in predementia Alzheimer's disease...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2011-11-17 - 2011-12-22","first_published_date":"2011-12-02T16:30:00Z","last_updated_date":"2011-12-02T16:30:00Z","reference_number":"EMA/CHMP/SAWP/892998/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-alzheimers-disease-novel-methodologies-biomarkers-positron-emission-tomograpy-amyloid-imaging-positive-negative-biomarker-enrichment-use-predementia-alzheimers-disease_en.pdf"},
    {"id":"29875","name":"Draft guideline on good pharmacovigilance practices: Annex I - Definitions","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T15:20:00Z","last_updated_date":"2012-02-22T15:20:00Z","reference_number":"EMA/876333/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-annex-i-definitions_en.pdf"},
    {"id":"29890","name":"Concept paper on the development of a guideline on the risk-based approach according to annex I, part IV of directive 2001/83/EC applied to advanced therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-17 - 2010-03-31","first_published_date":"2010-01-26T02:00:00Z","last_updated_date":"2010-01-26T02:00:00Z","reference_number":"EMA/CHMP/CPWP/708420/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-risk-based-approach-according-annex-i-part-iv-directive-2001-83-ec-applied-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"29907","name":"Concept paper on the revision of the guideline on radiopharmaceuticals based on monoclonal antibodies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-09-24 - 2010-01-31","first_published_date":"2009-11-03T01:09:21Z","last_updated_date":"2009-11-03T01:09:21Z","reference_number":"EMEA/CHMP/CVMP/362268/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-radiopharmaceuticals-based-monoclonal-antibodies_en.pdf"},
    {"id":"30000","name":"Guideline on real-time release testing (formerly guideline on parametric release) - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-03-15 - 2012-10-31","first_published_date":"2012-04-13T15:50:00Z","last_updated_date":"2012-04-13T15:50:00Z","reference_number":"EMA/CHMP/QWP/811210/2009-Rev1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-real-time-release-testing-formerly-guideline-parametric-release-revision-1_en.pdf"},
    {"id":"30008","name":"Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-26 - 2016-06-26","first_published_date":"2016-05-26T20:00:00Z","last_updated_date":"2016-05-26T20:00:00Z","reference_number":"EMA/231573/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/updated-advice-use-colistin-products-animals-within-european-union-development-resistance-and-possible-impact-human-and-animal-health_en.pdf"},
    {"id":"30046","name":"Inventory of paediatric therapeutic needs - Gastroenterology","type":"other","status":"Draft: consultation closed","consultation_date":"2015-05-08 - 2015-07-06","first_published_date":"2015-05-11T18:05:00Z","last_updated_date":"2015-06-01T18:05:00Z","reference_number":"EMA/PDCO/43828/2015 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/other/inventory-paediatric-therapeutic-needs-gastroenterology_en.pdf-0"},
    {"id":"30049","name":"Draft community herbal monograph on Trigonella foenumgraecum L., semen","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-09-15","first_published_date":"2010-06-10T04:00:00Z","last_updated_date":"2010-06-10T04:00:00Z","reference_number":"EMA/HMPC/146221/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-trigonella-foenumgraecum-l-semen_en.pdf"},
    {"id":"30127","name":"VICH Topic GL47: at step 4: Guideline on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-12-10 - 2010-05-20","first_published_date":"2009-12-22T02:00:00Z","last_updated_date":"2010-05-10T04:00:00Z","reference_number":"EMEA/CVMP/VICH/463104/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-topic-gl47-step-4-guideline-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-animals-comparative-metabolism-studies-laboratory-animals_en.pdf"},
    {"id":"30200","name":"Draft guideline on influenza vaccines: non-clinical and clinical module","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-31 - 2015-01-31","first_published_date":"2014-07-31T18:30:00Z","last_updated_date":"2014-07-31T18:30:00Z","reference_number":"EMA/CHMP/VWP/457259/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-influenza-vaccines-non-clinical-and-clinical-module_en.pdf"},
    {"id":"30225","name":"Draft community herbal monograph on Chamaemelum nobile (L.) All., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-02-14T02:00:00Z","last_updated_date":"2011-02-14T02:00:00Z","reference_number":"EMA/HMPC/560734/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"30268","name":"Draft telithromycin product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/422605/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-telithromycin-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"30281","name":"Draft Community herbal monograph on Panax ginseng C.A. Meyer, radix","type":"herbal-opinion","status":"Draft: consultation closed","consultation_date":"2013-04-15 - 2013-07-15","first_published_date":"2013-04-16T04:00:00Z","last_updated_date":"2013-04-16T04:00:00Z","reference_number":"EMA/HMPC/321233/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/draft-community-herbal-monograph-panax-ginseng-ca-meyer-radix_en.pdf"},
    {"id":"30285","name":"Draft questions and answers on propylene glycol and esters in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-12-01 - 2015-02-28","first_published_date":"2014-12-01T19:20:00Z","last_updated_date":"2014-12-01T19:20:00Z","reference_number":"EMA/CHMP/704195/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-propylene-glycol-and-esters-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"30346","name":"Call for submission of scientific data on Uncaria tomentosa (Willd.) DC., cortex (Cat's Claw)","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2010-10-01 - 2010-12-15","first_published_date":"2010-10-07T04:00:00Z","last_updated_date":"2010-10-07T04:00:00Z","reference_number":"EMA/HMPC/615722/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-uncaria-tomentosa-willd-dc-cortex-cats-claw_en.pdf"},
    {"id":"30349","name":"Call for scientific data for use in HMPC assessment work on Paeoniae radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-17T12:05:00Z","last_updated_date":"2014-02-17T12:05:00Z","reference_number":"EMA/HMPC/87628/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-paeoniae-radix_en.pdf"},
    {"id":"30352","name":"Draft European Union herbal monograph on Mentha x piperita L., folium - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-02-23 - 2017-05-31","first_published_date":"2017-02-23T18:58:00Z","last_updated_date":"2017-03-08T18:58:00Z","reference_number":"EMA/HMPC/572705/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-mentha-x-piperita-l-folium-revision-1_en.pdf"},
    {"id":"30411","name":"Draft European Union herbal monograph on Valeriana officinalis L., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-31","first_published_date":"2015-07-23T20:15:00Z","last_updated_date":"2015-07-23T20:15:00Z","reference_number":"EMA/HMPC/150848/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"30450","name":"Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-03-22 - 2017-06-22","first_published_date":"2017-03-22T18:15:00Z","last_updated_date":"2017-03-22T18:15:00Z","reference_number":"EMA/CHMP/QWP/115777/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-pharmaceutical-quality-inhalation-and-nasal-products_en.pdf"},
    {"id":"30563","name":"Draft Community herbal monograph on Olea europaea L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-08-15","first_published_date":"2011-02-11T02:00:00Z","last_updated_date":"2011-06-16T04:00:00Z","reference_number":"EMA/HMPC/430507/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-olea-europaea-l-folium_en.pdf"},
    {"id":"30635","name":"Draft guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-29 - 2017-01-31","first_published_date":"2016-07-29T20:15:00Z","last_updated_date":"2016-07-29T20:15:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/94436/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guidance-individual-laboratories-transfer-quality-control-methods-validated-collaborative-trials-view-implementing-3rs_en.pdf"},
    {"id":"30636","name":"Concept paper on assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicine","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-07-15 - 2010-09-01","first_published_date":"2010-07-19T04:00:00Z","last_updated_date":"2010-07-19T04:00:00Z","reference_number":"EMA/CVMP/ERAWP/389867/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-assessment-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpvb-substances-veterinary-medicine_en.pdf"},
    {"id":"30712","name":"Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism in non-surgical patients (formerly CPMP/EWP/6235/04 Rev.1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-11-16 - 2016-05-15","first_published_date":"2016-10-12T14:00:00Z","last_updated_date":"2016-10-12T14:00:00Z","reference_number":"EMA/CHMP/41252/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-prevention-venous-thromboembolism-non-surgical-patients-formerly-cpmp-ewp-6235-04-rev1_en.pdf"},
    {"id":"30725","name":"Draft review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-29 - 2016-10-31","first_published_date":"2016-07-29T20:15:00Z","last_updated_date":"2016-07-29T20:15:00Z","reference_number":"EMA/CHMP/CVMP/JEG-3Rs/677407/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-review-and-update-ema-guidelines-implement-best-practice-regard-3rs-replacement-reduction-and-refinement-regulatory-testing-medicinal-products-report-actions-taken_en.pdf"},
    {"id":"30778","name":"Draft questions and Answers on the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-09-30","first_published_date":"2010-07-19T04:00:00Z","last_updated_date":"2010-07-19T04:00:00Z","reference_number":"EMA/CHMP/SWP/44609/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf"},
    {"id":"30784","name":"Draft concept paper for the development of a reflection paper on the use of extended-spectrum penicillins in animals in the European Union: development of resistance and impact on human and animal health - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-17 - 2015-10-31","first_published_date":"2015-07-17T13:15:00Z","last_updated_date":"2015-07-17T13:15:00Z","reference_number":"EMA/CVMP/AWP/37203/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-reflection-paper-use-extended-spectrum-penicillins-animals-european-union-development-resistance-and-impact-human-and-animal-health-first-version_en.pdf"},
    {"id":"30787","name":"Template for a public statement when no Community herbal monograph is established","type":"template-form","status":"unknown","consultation_date":"2011-02-15 - 2011-05-15","first_published_date":"2011-02-16T02:00:00Z","last_updated_date":"2020-07-29T17:33:00Z","reference_number":"EMA/HMPC/75972/2010 Rev. 1 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-public-statement-when-no-community-herbal-monograph-established_en.pdf"},
    {"id":"30826","name":"Draft guideline on pharmaceutical development of medicines for paediatric use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-05-01 - 2011-12-31","first_published_date":"2011-06-23T04:00:00Z","last_updated_date":"2011-06-23T04:00:00Z","reference_number":"EMA/CHMP/QWP/180157/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-pharmaceutical-development-medicines-paediatric-use_en.pdf-0"},
    {"id":"30858","name":"Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘urinary tract disorders’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/816399/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-herbal-tea-combinations-traditionally-used-therapeutic-area-urinary-tract-disorders_en.pdf"},
    {"id":"31044","name":"Concept paper on similar biological product containing recombinant follicle stimulation hormone","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-03-18 - 2010-06-11","first_published_date":"2010-04-06T04:00:00Z","last_updated_date":"2010-04-06T04:00:00Z","reference_number":"EMA/CHMP/BMWP/94899/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-similar-biological-product-containing-recombinant-follicle-stimulation-hormone_en.pdf"},
    {"id":"31076","name":"Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-05-20 - 2015-08-31","first_published_date":"2015-05-20T22:30:00Z","last_updated_date":"2015-05-20T22:30:00Z","reference_number":"EMA/CAT/80183/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-non-clinical-and-clinical-aspects-gene-therapy-medicinal-products_en.pdf"},
    {"id":"31133","name":"Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-01-19 - 2012-06-30","first_published_date":"2012-01-24T13:55:00Z","last_updated_date":"2012-01-24T13:55:00Z","reference_number":"EMA/CAT/CPWP/686637/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-risk-based-approach-according-annex-i-part-iv-directive-2001-83-ec-applied-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"31134","name":"Draft note for guidance on clinical investigation of medicinal products for treatment of asthma - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-07-01 - 2013-12-31","first_published_date":"2013-07-01T20:15:00Z","last_updated_date":"2013-07-01T20:15:00Z","reference_number":"CHMP/EWP/2922/01 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-note-guidance-clinical-investigation-medicinal-products-treatment-asthma-revision-1_en.pdf"},
    {"id":"31156","name":"Draft questions and answers on 'Guideline on the environmental risk assessment of medicinal products for human use' - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-31 - 2015-06-30","first_published_date":"2015-03-31T16:00:00Z","last_updated_date":"2015-03-31T16:00:00Z","reference_number":"EMA/CHMP/SWP/44609/2010 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-guideline-environmental-risk-assessment-medicinal-products-human-use-revision-1_en.pdf"},
    {"id":"31179","name":"Draft lenalidomide hard gelatine capsules 2.5, 5, 7.5, 10, 15 and 25mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-01 - 2016-01-01","first_published_date":"2015-10-06T17:00:00Z","last_updated_date":"2015-10-06T17:00:00Z","reference_number":"EMA/CHMP/PKWP/152216/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-lenalidomide-hard-gelatine-capsules-25-5-75-10-15-and-25mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"31287","name":"Call for scientific data for the systematic review of the monograph on Mentha x piperita L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648284/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-mentha-x-piperita-l-folium_en.pdf"},
    {"id":"31378","name":"Draft guideline on the evaluation of anticancer medicinal products in man - Revision 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-05-31","first_published_date":"2011-12-22T12:20:00Z","last_updated_date":"2011-12-22T12:20:00Z","reference_number":"EMA/CHMP/205/95 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-anticancer-medicinal-products-man-revision-4_en.pdf"},
    {"id":"31489","name":"Concept paper for the revision of the guideline on the conduct of efficacy studies for intramammary products for use in cattle","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-15 - 2010-12-31","first_published_date":"2010-09-27T04:00:00Z","last_updated_date":"2010-09-27T04:00:00Z","reference_number":"EMA/CVMP/EWP/87114/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-conduct-efficacy-studies-intramammary-products-use-cattle_en.pdf"},
    {"id":"31497","name":"Draft Community herbal monograph on Agrimonia eupatoria L., herba - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-05-23 - 2014-08-31","first_published_date":"2014-05-23T04:00:00Z","last_updated_date":"2014-05-23T04:00:00Z","reference_number":"EMA/HMPC/680597/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-agrimonia-eupatoria-l-herba-first-version_en.pdf"},
    {"id":"31503","name":"Draft Community herbal monograph on Pelargonium sidoides DC and / or Pelargonium reniforme Curt., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-03-31 - 2011-08-15","first_published_date":"2011-04-26T04:00:00Z","last_updated_date":"2011-04-26T04:00:00Z","reference_number":"EMA/HMPC/560961/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-pelargonium-sidoides-dc-and-or-pelargonium-reniforme-curt-radix_en.pdf"},
    {"id":"31525","name":"Call for scientific data for use in HMPC assessment work on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-07-15","first_published_date":"2011-04-14T04:00:00Z","last_updated_date":"2011-04-14T04:00:00Z","reference_number":"EMA/HMPC/278488/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"31542","name":"Draft guideline on risk characterisation and assessment of maximum residue limits (MRLs) for biocides","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-12-08 - 2012-06-30","first_published_date":"2011-12-20T16:15:00Z","last_updated_date":"2011-12-20T16:15:00Z","reference_number":"EMA/CVMP/90250/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-risk-characterisation-and-assessment-maximum-residue-limits-mrls-biocides_en.pdf"},
    {"id":"31552","name":"Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-05 - 2018-09-30","first_published_date":"2018-06-26T18:20:00Z","last_updated_date":"2018-07-05T15:30:00Z","reference_number":"EMA/CHMP/800775/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-pegylated-liposomal-doxorubicin-hydrochloride-concentrate-solution-2-mg-ml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"31569","name":"Concept paper on the need for a guideline on multiplicity issues in clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-05-30 - 2012-08-30","first_published_date":"2012-05-30T15:30:00Z","last_updated_date":"2012-05-30T15:30:00Z","reference_number":"EMA/286914/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-multiplicity-issues-clinical-trials_en.pdf"},
    {"id":"31618","name":"Call for scientific data for the review of the HMPC assessment on Adhatoda vasica Nees, folium - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-04-30 - 2018-07-31","first_published_date":"2018-04-30T18:45:00Z","last_updated_date":"2018-04-30T18:45:00Z","reference_number":"EMA/HMPC/248464/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-review-hmpc-assessment-adhatoda-vasica-nees-folium-revision-1_en.pdf"},
    {"id":"31632","name":"Call for scientific data for the systematic review of the monograph on Passiflora incarnata L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558981/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-passiflora-incarnata-l-herba_en.pdf"},
    {"id":"31634","name":"Reflection paper on collecting and reporting information on off-label use in pharmacovigilance","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-29 - 2016-07-29","first_published_date":"2016-04-29T13:20:00Z","last_updated_date":"2016-04-29T13:20:00Z","reference_number":"EMA/293194/2016","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-collecting-and-reporting-information-label-use-pharmacovigilance_en.pdf"},
    {"id":"31680","name":"Draft community list entry on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2009-11-12 - 2010-06-15","first_published_date":"2010-03-23T02:00:00Z","last_updated_date":"2010-03-23T02:00:00Z","reference_number":"EMA/HMPC/704562/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-community-list-entry-hamamelis-virginiana-l-folium-et-cortex-aut-ramunculus-destillatum_en.pdf"},
    {"id":"31701","name":"Reflection paper on polycyclic aromatic hydrocarbons in herbal medicinal products/traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-06-29 - 2016-12-15","first_published_date":"2016-06-29T04:00:00Z","last_updated_date":"2016-06-29T04:00:00Z","reference_number":"EMA/HMPC/300551/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-polycyclic-aromatic-hydrocarbons-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"31713","name":"Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-10-31","first_published_date":"2016-08-01T17:00:00Z","last_updated_date":"2016-08-01T17:00:00Z","reference_number":"EMA/CHMP/474883/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vandetanib-film-coated-tablets-100-and-300-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"31751","name":"Draft guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-05-20 - 2010-09-01","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/CHMP/BWP/68803/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-isolation-candidate-influenza-vaccine-viruses-cell-culture_en.pdf"},
    {"id":"31762","name":"Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-11-17 - 2012-05-31","first_published_date":"2011-11-24T10:50:00Z","last_updated_date":"2011-11-24T10:50:00Z","reference_number":"EMA/CHMP/BMWP/671292/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-follicle-stimulating-hormone-r-hfsh_en.pdf"},
    {"id":"31801","name":"Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-01 - 2010-01-31","first_published_date":"2009-11-18T01:09:21Z","last_updated_date":"2009-11-18T01:09:21Z","reference_number":"EMEA/632613/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies_en.pdf"},
    {"id":"31830","name":"Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use'","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-24 - 2015-09-30","first_published_date":"2015-06-24T14:00:00Z","last_updated_date":"2015-06-24T14:00:00Z","reference_number":"EMA/CHMP/338679/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-questions-and-answers-sodium-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"31854","name":"Call for scientific data for the systematic review of the monograph on Echinacea pallida (Nutt.) Nutt., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/845008/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-echinacea-pallida-nutt-nutt-radix_en.pdf"},
    {"id":"31905","name":"European Union Medicines Agencies Network Strategy to 2020 - Working together to improve health","type":"other","status":"Draft: consultation closed","consultation_date":"2015-03-31 - 2015-06-30","first_published_date":"2015-03-31T15:00:00Z","last_updated_date":"2015-03-31T15:00:00Z","reference_number":"EMA/MB/151414/2015","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-medicines-agencies-network-strategy-2020-working-together-improve-health_en.pdf"},
    {"id":"31956","name":"Qualification opinion - The European Cystic Fibrosis Society Patient Registry (ECFSPR)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-09 - 2018-04-09","first_published_date":"2018-02-09T11:00:00Z","last_updated_date":"2018-02-09T11:00:00Z","reference_number":"EMA/CHMP/SAWP/802259/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-european-cystic-fibrosis-society-patient-registry-ecfspr_en.pdf"},
    {"id":"31957","name":"Draft European Union herbal monograph on Silybum marianum (L.) Gaertn., fructus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-31","first_published_date":"2015-07-23T14:50:00Z","last_updated_date":"2015-07-23T14:50:00Z","reference_number":"EMA/HMPC/294187/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-silybum-marianum-l-gaertn-fructus_en.pdf-0"},
    {"id":"31986","name":"Guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-01-27 - 2015-04-30","first_published_date":"2015-01-30T02:00:00Z","last_updated_date":"2015-01-30T02:00:00Z","reference_number":"EMA/CVMP/IWP/205351/2006-Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-procedure-be-followed-when-batch-vaccine-finished-product-suspected-be-contaminated-bovine-viral-diarrhoea-virus_en.pdf"},
    {"id":"32074","name":"Draft guideline on good pharmacovigilance practices: Module X – Additional monitoring","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-27 - 2012-08-24","first_published_date":"2012-06-27T16:57:58Z","last_updated_date":"2012-06-27T16:57:58Z","reference_number":"EMA/169546/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-x-additional-monitoring_en.pdf"},
    {"id":"32089","name":"Submission of comments on The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health","type":"template-form","status":"unknown","consultation_date":"2010-01-26 - 2010-04-30","first_published_date":"2010-01-26T02:00:00Z","last_updated_date":"2010-01-26T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-european-medicines-agency-road-map-2015-agencys-contribution-science-medicines-health_en.doc"},
    {"id":"32094","name":"Draft guideline on the clinical investigation of medicinal products to prevent development / slow progression of chronic renal insufficiency","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-01 - 2015-01-01","first_published_date":"2014-07-01T12:07:00Z","last_updated_date":"2014-07-01T12:07:00Z","reference_number":"EMA/CHMP/355988/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-prevent-development-slow-progression-chronic-renal-insufficiency_en.pdf"},
    {"id":"32125","name":"Concept Paper on the Revision of the Guideline on Process Validation - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-01-14 - 2010-05-31","first_published_date":"2010-03-03T02:00:00Z","last_updated_date":"2010-03-03T02:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/809114/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-process-validation-revision-1_en.pdf"},
    {"id":"32152","name":"Draft Community herbal monograph on Ononis spinosa L., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-08-19 - 2013-12-15","first_published_date":"2013-08-19T17:59:00Z","last_updated_date":"2013-08-19T17:59:00Z","reference_number":"EMA/HMPC/138317/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-ononis-spinosa-l-radix_en.pdf"},
    {"id":"32162","name":"Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (superseded)","type":"scientific-guideline","status":"unknown","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T04:00:00Z","last_updated_date":"2012-06-25T04:00:00Z","reference_number":"EMA/816573/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-ii-pharmacovigilance-system-master-file-superseded_en.pdf"},
    {"id":"32168","name":"Call for scientific data for use in HMPC assessment work on Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558956/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-rosa-centifolia-l-rosa-gallica-l-rosa-damascena-mill-aetheroleum_en.pdf"},
    {"id":"32236","name":"Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-11-18 - 2015-02-15","first_published_date":"2014-11-18T19:06:00Z","last_updated_date":"2014-11-18T19:06:00Z","reference_number":"EMA/CVMP/505827/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-data-requirements-veterinary-medicinal-products-minor-use-minor-species_en.pdf"},
    {"id":"32245","name":"VICH Topic GL35: Guideline on pharmacovigilance of veterinary medicinal products: electronic standards of data","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-16 - 2011-03-15","first_published_date":"2010-09-27T04:00:00Z","last_updated_date":"2010-09-27T04:00:00Z","reference_number":"EMA/CVMP/VICH/123940/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-topic-gl35-guideline-pharmacovigilance-veterinary-medicinal-products-electronic-standards-data_en.pdf"},
    {"id":"32257","name":"Draft guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-01 - 2013-08-31","first_published_date":"2013-03-01T13:30:00Z","last_updated_date":"2013-03-01T13:30:00Z","reference_number":"EMA/CHMP/BWP/814397/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-porcine-trypsin-used-manufacture-human-biological-medicinal-products_en.pdf"},
    {"id":"32277","name":"Call for scientific data for the systematic review of the monograph on Mentha x piperita L., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648282/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-mentha-x-piperita-l-aetheroleum_en.pdf"},
    {"id":"32419","name":"Draft guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-29 - 2017-01-31","first_published_date":"2016-07-29T20:00:00Z","last_updated_date":"2016-07-29T20:00:00Z","reference_number":"EMA/CHMP/458101/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-qualification-and-reporting-physiologically-based-pharmacokinetic-pbpk-modelling-and-simulation_en.pdf"},
    {"id":"32436","name":"Draft interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-03-07 - 2014-03-28","first_published_date":"2014-03-07T13:40:00Z","last_updated_date":"2014-03-07T13:40:00Z","reference_number":"EMA/PRAC/135943/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-interim-guidance-enhanced-safety-surveillance-seasonal-influenza-vaccines-eu_en.pdf"},
    {"id":"32561","name":"Call for scientific data for use in HMPC assessment work on Curcuma longa L., rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-07-23 - 2014-10-31","first_published_date":"2014-07-24T18:30:00Z","last_updated_date":"2014-07-24T18:30:00Z","reference_number":"EMA/HMPC/447914/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-curcuma-longa-l-rhizoma_en.pdf"},
    {"id":"32604","name":"Draft guideline on the investigation of drug interactions","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-10-31","first_published_date":"2010-04-30T04:00:00Z","last_updated_date":"2010-05-04T04:00:00Z","reference_number":"EMA/CHMP/EWP/125211/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-investigation-drug-interactions_en.pdf"},
    {"id":"32608","name":"Draft reflection paper on quality of essential oils as active substances in herbal medicinal products / traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-03-01T12:00:00Z","last_updated_date":"2013-03-01T12:00:00Z","reference_number":"EMA/HMPC/84789/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-quality-essential-oils-active-substances-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"32623","name":"Draft guideline on data requirements for veterinary medicinal products for the prevention of transmission of vector- borne diseases in dogs and cats","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-27 - 2019-08-31","first_published_date":"2018-07-27T14:37:00Z","last_updated_date":"2018-07-27T14:37:00Z","reference_number":"EMA/CVMP/EWP/278031/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-veterinary-medicinal-products-prevention-transmission-vector-borne-diseases-dogs-and-cats_en.pdf"},
    {"id":"32632","name":"Draft guideline on clinical evaluation of medicinal products for the treatment of chronic hepatitis C","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-01-20 - 2011-08-31","first_published_date":"2011-02-14T02:00:00Z","last_updated_date":"2011-02-14T02:00:00Z","reference_number":"EMEA/CHMP/51240/2011 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-evaluation-medicinal-products-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"32707","name":"Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-11-17 - 2017-02-17","first_published_date":"2016-11-17T02:00:00Z","last_updated_date":"2016-11-17T02:00:00Z","reference_number":"EMA/CVMP/QWP/3629/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-chemical-structure-and-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances-veterinary_en.pdf"},
    {"id":"32716","name":"Concept paper on the involvement of children and young people at the Paediatric Committee (PDCO)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-09-17 - 2012-11-19","first_published_date":"2012-09-17T20:30:00Z","last_updated_date":"2012-09-17T20:30:00Z","reference_number":"EMA/PDCO/388684/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-involvement-children-and-young-people-paediatric-committee-pdco_en.pdf"},
    {"id":"32743","name":"Draft concept paper on guidance for the collection of data on antimicrobial consumption by species from national data collection systems","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-07-13 - 2016-09-30","first_published_date":"2016-07-13T21:25:00Z","last_updated_date":"2016-07-13T21:25:00Z","reference_number":"EMA/321085/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-guidance-collection-data-antimicrobial-consumption-species-national-data-collection-systems_en.pdf"},
    {"id":"32838","name":"Draft guideline on the data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of regulation (EC) No 470/2009","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-11-11 - 2009-05-31","first_published_date":"2009-11-17T02:00:00Z","last_updated_date":"2010-05-10T04:00:00Z","reference_number":"EMEA/CVMP/516817/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-be-provided-support-request-include-substance-list-substances-considered-not-falling-within-scope-regulation-ec-no-470-2009_en.pdf"},
    {"id":"32840","name":"Draft assessment report on Achillea millefolium L., flos","type":"herbal-report","status":"Draft","consultation_date":"2010-11-15 - 2011-02-15","first_published_date":"2010-11-09T02:00:00Z","last_updated_date":"2010-11-09T02:00:00Z","reference_number":"EMA/HMPC/149343/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-achillea-millefolium-l-flos_en.pdf"},
    {"id":"32904","name":"Draft paediatric addendum to CHMP note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-12-31","first_published_date":"2010-07-08T04:00:00Z","last_updated_date":"2010-07-08T04:00:00Z","reference_number":"EMA/CHMP/213057/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paediatric-addendum-chmp-note-guidance-clinical-investigation-medicinal-products-treatment-lipid-disorders_en.pdf"},
    {"id":"32909","name":"Draft community herbal monograph on Tanacetum parthenium (L.) Schulz Bip., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-08-15","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/HMPC/587578/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-tanacetum-parthenium-l-schulz-bip-herba_en.pdf"},
    {"id":"32910","name":"Call for scientific data for use in HMPC assessment work on Andrographis paniculata Nees, folium - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-02-15 - 2011-05-15","first_published_date":"2011-02-17T02:00:00Z","last_updated_date":"2011-02-17T02:00:00Z","reference_number":"EMA/HMPC/129735/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-andrographis-paniculata-nees-folium-first-version_en.pdf"},
    {"id":"33005","name":"Concept paper on a revision of the guideline for an assessor preparing assessment reports","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2009-10-01 - 2009-12-31","first_published_date":"2009-10-19T04:00:00Z","last_updated_date":"2009-10-19T04:00:00Z","reference_number":"EMEA/CVMP/626480/2009","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-guideline-assessor-preparing-assessment-reports_en.pdf"},
    {"id":"33014","name":"Concept paper on the revision of the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for sim...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-09-02 - 2016-11-30","first_published_date":"2016-09-02T13:45:00Z","last_updated_date":"2016-09-02T13:45:00Z","reference_number":"EMA/HMPC/353983/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-non-clinical-documentation-herbal-medicinal-products-applications-marketing-authorisation-bibliographical-and-mixed-applications-and-applications-sim_en.pdf"},
    {"id":"33049","name":"Concept paper on an addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 2) to address indication-specific clinical data requirements","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2011-12-31","first_published_date":"2011-10-06T18:16:00Z","last_updated_date":"2011-10-06T18:16:00Z","reference_number":"EMA/CHMP/EWP/736904/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-cpmp-ewp-558-95-rev-2-address-indication-specific-clinical-data-requirements_en.pdf"},
    {"id":"33127","name":"Call for scientific data for the systematic review of the monograph on Valeriana officinalis L., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558991/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-valeriana-officinalis-l-radix_en.pdf"},
    {"id":"33159","name":"Draft paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-06-10 - 2015-11-30","first_published_date":"2015-06-10T15:14:00Z","last_updated_date":"2015-06-10T15:14:00Z","reference_number":"EMA/CHMP/707532/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paediatric-addendum-chmp-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure_en.pdf"},
    {"id":"33175","name":"Draft community herbal monograph on Syzygium aromaticum (L.) Merill et L. M. Perry, floris aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-01-27 - 2011-06-15","first_published_date":"2011-02-10T02:00:00Z","last_updated_date":"2011-02-10T02:00:00Z","reference_number":"EMA/HMPC/534924/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-syzygium-aromaticum-l-merill-et-l-m-perry-floris-aetheroleum_en.pdf"},
    {"id":"33181","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal product for the treatment of migraine","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-10-21 - 2017-01-31","first_published_date":"2016-10-21T15:00:00Z","last_updated_date":"2016-10-21T15:00:00Z","reference_number":"EMA/CHMP/179671/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-product-treatment-migraine_en.pdf"},
    {"id":"33185","name":"Draft risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-14 - 2015-06-14","first_published_date":"2015-04-14T18:00:00Z","last_updated_date":"2015-04-14T18:00:00Z","reference_number":"EMA/686009/2014","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-risk-minimisation-strategy-high-strength-and-fixed-combination-insulin-products-addendum-good-practice-guide-risk-minimisation-and-prevention-medication-errors_en.pdf"},
    {"id":"33250","name":"Draft Community herbal monograph on Matricaria recutita L., flos - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-07-24 - 2014-10-31","first_published_date":"2014-07-24T19:50:00Z","last_updated_date":"2014-07-24T19:50:00Z","reference_number":"EMA/HMPC/55843/2011 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-matricaria-recutita-l-flos-first-version_en.pdf"},
    {"id":"33347","name":"Draft guideline on manufacture of the finished dosage form - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-09 - 2016-01-09","first_published_date":"2015-07-09T15:40:00Z","last_updated_date":"2015-07-09T15:40:00Z","reference_number":"EMA/CHMP/QWP/245074/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-manufacture-finished-dosage-form-revision-1_en.pdf"},
    {"id":"33352","name":"Concept paper on the need for a single note for guidance on the chemistry of active substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-22 - 2015-10-22","first_published_date":"2015-07-22T18:25:00Z","last_updated_date":"2015-07-22T18:25:00Z","reference_number":"EMA/CVMP/QWP/107359/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-single-note-guidance-chemistry-active-substances_en.pdf-0"},
    {"id":"33388","name":"Concept paper on the need for a guideline on the evaluation of drugs for the treatment of Gastroesophageal Reflux disease (GERD)","type":"scientific-guideline","status":"unknown","consultation_date":"2009-02-01 - 2009-05-31","first_published_date":"2009-02-19T02:00:00Z","last_updated_date":"2009-02-19T02:00:00Z","reference_number":"EMEA/CHMP/EWP/15839/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-evaluation-drugs-treatment-gastroesophageal-reflux-disease-gerd_en.pdf"},
    {"id":"33391","name":"Draft assessment report on Chamaemelum nobile (L.) All., flos","type":"herbal-report","status":"Draft","consultation_date":"2011-02-15 - 2011-06-15","first_published_date":"2011-03-02T02:00:00Z","last_updated_date":"2011-03-02T02:00:00Z","reference_number":"EMA/HMPC/560906/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-chamaemelum-nobile-l-all-flos_en.pdf"},
    {"id":"33417","name":"Draft CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-09-30","first_published_date":"2010-07-27T04:00:00Z","last_updated_date":"2010-07-27T04:00:00Z","reference_number":"EMEA/CPMP/BWP/2879/02/rev 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-chmp-position-statement-creutzfeldt-jakob-disease-and-plasma-derived-and-urine-derived-medicinal-products-revision-2_en.pdf"},
    {"id":"33430","name":"Concept paper on the need for a guideline on the clinical investigation of medicianl products intended for treatment of systematic and cutaneous lupus erythematosus","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2009-11-19 - 2010-02-28","first_published_date":"2009-12-02T01:09:21Z","last_updated_date":"2009-12-02T01:09:21Z","reference_number":"EMEA/CHMP/EWP/604040/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-investigation-medicianl-products-intended-treatment-systematic-and-cutaneous-lupus-erythematosus_en.pdf"},
    {"id":"33480","name":"Draft European Union herbal monograph on Fragaria vesca L., Fragaria moschata Weston, Fragaria viridis Weston and Fragaria x ananassa (Weston) Duchesne ex Rozier, folium - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2018-04-11 - 2018-07-15","first_published_date":"2018-04-11T14:30:00Z","last_updated_date":"2018-04-11T14:30:00Z","reference_number":"EMA/HMPC/432278/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-fragaria-vesca-l-fragaria-moschata-weston-fragaria-viridis-weston-and-fragaria-x-ananassa-weston-duchesne-ex-rozier-folium-first-version_en.pdf"},
    {"id":"33511","name":"Draft European Union herbal monograph on Ruscus aculeatus L. rhizoma- Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2018-03-08 - 2018-06-15","first_published_date":"2018-03-08T10:30:00Z","last_updated_date":"2018-03-08T10:30:00Z","reference_number":"EMA/188804/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-ruscus-aculeatus-l-rhizoma-revision-1_en.pdf"},
    {"id":"33574","name":"Draft imatinib product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423733/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-imatinib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"33580","name":"Draft guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-02 - 2017-10-13","first_published_date":"2017-08-02T14:00:01Z","last_updated_date":"2017-08-02T14:00:01Z","reference_number":"EMA/572054/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-product-or-population-specific-considerations-iv-paediatric-population_en.pdf"},
    {"id":"33683","name":"Draft ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities)","type":"scientific-guideline","status":"Draft","consultation_date":"2011-05-01 - 2011-09-16","first_published_date":"2011-06-16T04:00:00Z","last_updated_date":"2012-05-25T17:45:00Z","reference_number":"EMA/CHMP/ICH/425213/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnological-biological-entities_en.pdf"},
    {"id":"33693","name":"Call for scientific data for the systematic review of the monograph on Achillea millefolium L., flos and Achillea millefolium L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/844895/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-achillea-millefolium-l-flos-and-achillea-millefolium-l-herba_en.pdf-0"},
    {"id":"33745","name":"Call for scientific data for use in HMPC assessment work on Salviae trilobae folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-17T11:10:00Z","last_updated_date":"2014-02-17T11:10:00Z","reference_number":"EMA/HMPC/87640/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-salviae-trilobae-folium_en.pdf"},
    {"id":"33757","name":"Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon al...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-01-04 - 2016-03-31","first_published_date":"2016-01-04T13:00:00Z","last_updated_date":"2016-01-04T13:00:00Z","reference_number":"EMA/CHMP/BMWP/693108/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-reflection-paper-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-interferon-alpha-or-pegylated-recombinant-interferon-al_en.pdf"},
    {"id":"33788","name":"Call for scientific data for use in HMPC assessment work on Prunus africana (Hook f.) Kalkm., cortex","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558955/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-prunus-africana-hook-f-kalkm-cortex_en.pdf"},
    {"id":"33801","name":"Draft guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-03 - 2016-07-31","first_published_date":"2016-02-03T13:00:00Z","last_updated_date":"2016-02-03T13:00:00Z","reference_number":"EMA/CVMP/IWP/123243/2006 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-immunological-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market-revision-3_en.pdf"},
    {"id":"33819","name":"Draft inventory of paediatric medicines - Infectious diseases","type":"other","status":"Draft: consultation closed","consultation_date":"2013-05-15 - 2013-07-26","first_published_date":"2013-05-15T20:20:00Z","last_updated_date":"2013-06-18T16:00:00Z","reference_number":"EMA/PDCO/287222/2012","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-medicines-infectious-diseases_en.pdf"},
    {"id":"33822","name":"Concept paper on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-15 - 2012-05-15","first_published_date":"2012-02-15T11:00:00Z","last_updated_date":"2012-02-15T11:00:00Z","reference_number":"EMA/CHMP/917570/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-key-aspects-use-pharmacogenomic-methodologies-pharmacovigilance-evaluation-medicinal-products_en.pdf"},
    {"id":"33858","name":"Draft concept paper on the development of medicinal products for the treatment of autism spectrum disorder","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-04 - 2013-07-04","first_published_date":"2013-04-03T21:30:00Z","last_updated_date":"2013-04-03T21:30:00Z","reference_number":"EMA/CHMP/40896/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-medicinal-products-treatment-autism-spectrum-disorder_en.pdf"},
    {"id":"33865","name":"Concept paper on the second revision of the guideline on the use of the Common Technical Document format in the preparation of a registration application for traditional herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-12-03 - 2014-03-15","first_published_date":"2013-12-03T11:55:00Z","last_updated_date":"2013-12-03T11:55:00Z","reference_number":"EMA/HMPC/555178/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-second-revision-guideline-use-common-technical-document-format-preparation-registration-application-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"33873","name":"Concept paper on the development of toxicological guidance for use in risk identification in the manufacture of different medicinal products in shared facilities","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-10-20 - 2012-01-31","first_published_date":"2011-10-28T17:40:00Z","last_updated_date":"2011-10-28T17:40:00Z","reference_number":"EMA/CHMP/SWP/598303/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-toxicological-guidance-use-risk-identification-manufacture-different-medicinal-products-shared-facilities_en.pdf"},
    {"id":"33875","name":"Question & answers on the note for guidance on photosafety testing","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-06-24 - 2010-09-30","first_published_date":"2010-07-19T04:00:00Z","last_updated_date":"2010-07-19T04:00:00Z","reference_number":"EMA/CHMP/SWP/336670/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/question-answers-note-guidance-photosafety-testing_en.pdf"},
    {"id":"33882","name":"Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled prod...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-03-22 - 2017-06-30","first_published_date":"2017-03-22T18:16:00Z","last_updated_date":"2017-03-22T18:16:00Z","reference_number":"EMA/CHMP/267194/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-requirements-clinical-documentation-orally-inhaled-products-oip-including-requirements-demonstration-therapeutic-equivalence-between-two-inhaled-prod_en.pdf"},
    {"id":"33891","name":"Call for scientific data for the systematic review of the monograph on Ruscus aculeatus L., rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-04-15 - 2016-07-15","first_published_date":"2016-04-15T20:00:00Z","last_updated_date":"2016-04-15T20:00:00Z","reference_number":"EMA/269960/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-ruscus-aculeatus-l-rhizoma_en.pdf"},
    {"id":"34067","name":"Draft guideline on the non-clinical development of fixed combinations of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2005-10-12 - 2006-04-30","first_published_date":"2005-10-13T04:00:00Z","last_updated_date":"2005-10-13T04:00:00Z","reference_number":"CHMP/EMEA/CHMP/SWP/258498/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-development-fixed-combinations-medicinal-products_en.pdf"},
    {"id":"34106","name":"Draft guideline on the clinical development of medicinal products for the treatment of Autism Spectrum Disorder (ASD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-03-04 - 2016-08-31","first_published_date":"2016-03-04T14:00:00Z","last_updated_date":"2016-03-04T14:00:00Z","reference_number":"EMA/CHMP/598082/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-treatment-autism-spectrum-disorder-asd_en.pdf"},
    {"id":"34128","name":"Call for scientific data for the systematic review of the monograph on Fragaria vesca L., folium - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-12-12 - 2015-03-15","first_published_date":"2014-12-15T13:40:00Z","last_updated_date":"2014-12-15T13:40:00Z","reference_number":"EMA/HMPC/776619/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-fragaria-vesca-l-folium-first-version_en.pdf"},
    {"id":"34132","name":"Draft Pazopanib film-coated tablet 200mg and 400mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-02 - 2016-07-31","first_published_date":"2016-05-02T13:00:00Z","last_updated_date":"2016-05-02T13:00:00Z","reference_number":"EMA/CHMP/154805/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-pazopanib-film-coated-tablet-200mg-and-400mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"34150","name":"Draft Community herbal monograph on Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-12-20 - 2014-04-15","first_published_date":"2013-12-20T13:00:00Z","last_updated_date":"2013-12-20T13:00:00Z","reference_number":"EMA/HMPC/137299/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-rosa-centifolia-l-rosa-gallica-l-rosa-damascena-mill-flos_en.pdf"},
    {"id":"34165","name":"Draft posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-31 - 2018-04-30","first_published_date":"2018-01-31T14:15:00Z","last_updated_date":"2018-01-31T14:15:00Z","reference_number":"EMA/CHMP/800785/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-posaconazole-gastro-resistant-tablet-100-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"34208","name":"Draft assessment report on Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-report","status":"Draft","consultation_date":"2011-05-15 - 2011-08-15","first_published_date":"2011-05-30T04:00:00Z","last_updated_date":"2015-02-10T02:00:00Z","reference_number":"EMA/HMPC/85124/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"34262","name":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on electronic common technical document v4.0 draft ICH implementation guide v2.0 - Step 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-03 - 2015-05-22","first_published_date":"2015-03-03T12:00:00Z","last_updated_date":"2015-03-16T12:00:00Z","reference_number":"EMA/CHMP/ICH/143002/2015 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-electronic-common-technical-document-v40-draft-ich-implementation-guide-v20-step-2_en.pdf"},
    {"id":"34286","name":"Draft VICH GL54: Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish an acute reference dose (ARfD)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-20 - 2015-08-15","first_published_date":"2015-03-20T17:00:00Z","last_updated_date":"2015-03-20T17:00:00Z","reference_number":"EMA/VICH/699251/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl54-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-acute-reference-dose-arfd_en.pdf"},
    {"id":"34305","name":"Draft European Union herbal monograph on Glycine max (L.) Merr., lecithin","type":"herbal-monograph","status":"Draft","consultation_date":"2016-07-27 - 2016-10-31","first_published_date":"2016-07-27T17:40:00Z","last_updated_date":"2016-07-27T17:40:00Z","reference_number":"EMA/HMPC/220599/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-glycine-max-l-merr-lecithin_en.pdf"},
    {"id":"34392","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolic risk in non-surgical patients","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-15 - 2014-10-15","first_published_date":"2014-07-16T19:10:00Z","last_updated_date":"2014-07-16T19:10:00Z","reference_number":"EMA/CHMP/283524/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-prophylaxis-venous-thromboembolic-risk-non-surgical-patients_en.pdf"},
    {"id":"34405","name":"Draft guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-10 - 2013-11-30","first_published_date":"2013-06-10T14:39:00Z","last_updated_date":"2013-06-10T14:39:00Z","reference_number":"EMEA/CHMP/BMWP/42832/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues_en.pdf"},
    {"id":"34408","name":"Draft VICH GL55: Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-26 - 2016-08-01","first_published_date":"2016-02-26T16:30:00Z","last_updated_date":"2016-02-26T16:30:00Z","reference_number":"EMA/CVMP/VICH/313610/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl55-harmonisation-criteria-waive-target-animal-batch-safety-testing-live-vaccines-veterinary-use_en.pdf"},
    {"id":"34441","name":"Draft guideline on the use of phthalates as excipients in human medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-05-08 - 2013-10-31","first_published_date":"2013-05-08T14:00:00Z","last_updated_date":"2013-05-08T14:00:00Z","reference_number":"EMA/CHMP/SWP/362974/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-phthalates-excipients-human-medicinal-products_en.pdf"},
    {"id":"34458","name":"Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘digestive disorders’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2017-02-28 - 2017-05-31","first_published_date":"2017-03-06T16:00:00Z","last_updated_date":"2017-03-06T16:00:00Z","reference_number":"EMA/HMPC/133337/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-herbal-tea-combinations-traditionally-used-therapeutic-area-digestive-disorders_en.pdf"},
    {"id":"34469","name":"Call for scientific data for the systematic review of the monograph on Pimpinella anisum L., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558974/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-pimpinella-anisum-l-fructus_en.pdf"},
    {"id":"34470","name":"VICH GL34: Guideline on testing for the detection of mycoplasma contamination","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-12-09 - 2011-03-31","first_published_date":"2002-04-26T04:00:00Z","last_updated_date":"2010-12-15T02:00:00Z","reference_number":"EMA/CVMP/VICH/463/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl34-guideline-testing-detection-mycoplasma-contamination_en.pdf"},
    {"id":"34481","name":"Concept paper on the revision of the guideline on nonclinical and clinical development of similar biological medicinal products containing recombinant human insulin","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-07-21 - 2011-09-30","first_published_date":"2011-07-27T04:00:00Z","last_updated_date":"2011-07-27T04:00:00Z","reference_number":"EMA/CHMP/BMWP/506470/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-nonclinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-insulin_en.pdf"},
    {"id":"34531","name":"Call for scientific data for use in HMPC assessment work on Helichrysi flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-17T11:45:00Z","last_updated_date":"2014-02-17T11:45:00Z","reference_number":"EMA/HMPC/87622/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-helichrysi-flos_en.pdf"},
    {"id":"34546","name":"Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-09-28 - 2016-12-31","first_published_date":"2016-09-28T17:35:00Z","last_updated_date":"2016-09-28T17:35:00Z","reference_number":"EMA/CVMP/IWP/867388/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-blue-tongue-and-foot-and-mouth-disease-revision-1_en.pdf"},
    {"id":"34647","name":"Concept paper for a guideline on limits for genotoxic impurities","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-18 - 2013-04-30","first_published_date":"2013-01-18T11:00:00Z","last_updated_date":"2013-01-18T11:00:00Z","reference_number":"EMA/CVMP/SWP/398880/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-limits-genotoxic-impurities_en.pdf"},
    {"id":"34654","name":"Draft gefitinib film-coated tablet 250 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-27 - 2018-09-30","first_published_date":"2018-06-27T14:30:00Z","last_updated_date":"2018-06-27T14:30:00Z","reference_number":"EMA/CHMP/257026/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-gefitinib-film-coated-tablet-250-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"34683","name":"Call for scientific data for use in HMPC assessment work on Ilex paraguariensis St. Hilaire, folium – First round","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/131776/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-ilex-paraguariensis-st-hilaire-folium-first-round_en.pdf"},
    {"id":"34720","name":"Draft scientific guidance on post-authorisation efficacy studies - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-11-06 - 2016-01-31","first_published_date":"2015-11-06T14:00:00Z","last_updated_date":"2015-11-06T14:00:00Z","reference_number":"EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-scientific-guidance-post-authorisation-efficacy-studies-first-version_en.pdf"},
    {"id":"34723","name":"Draft assessment report on Sisymbrium officinale (L.) Scop., herba","type":"herbal-report","status":"Draft","consultation_date":"2014-01-15 - 2014-04-15","first_published_date":"2014-01-17T02:00:00Z","last_updated_date":"2014-01-17T02:00:00Z","reference_number":"EMA/HMPC/280194/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-sisymbrium-officinale-l-scop-herba_en.pdf"},
    {"id":"34742","name":"Call for scientific data for the systematic review of the monograph on Meliloti herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-03-15 - 2014-06-15","first_published_date":"2014-03-14T18:15:00Z","last_updated_date":"2014-03-14T18:15:00Z","reference_number":"EMA/HMPC/143302/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-meliloti-herba_en.pdf"},
    {"id":"34779","name":"Draft guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-02-24 - 2017-08-31","first_published_date":"2017-02-24T18:00:00Z","last_updated_date":"2017-02-24T18:00:00Z","reference_number":"EMA/CVMP/ERA/103555/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-assessing-toxicological-risk-human-health-and-groundwater-communities-veterinary-pharmaceuticals-groundwater_en.pdf"},
    {"id":"34867","name":"Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-10-01 - 2012-12-15","first_published_date":"2012-09-28T15:30:00Z","last_updated_date":"2012-09-28T15:30:00Z","reference_number":"EMA/CHMP/520782/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis_en.pdf"},
    {"id":"34900","name":"Draft qualification opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of phase-II dose-finding studies under model uncertainty","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2013-10-15 - 2013-11-24","first_published_date":"2013-10-15T21:00:00Z","last_updated_date":"2013-10-15T21:00:00Z","reference_number":"EMA/CHMP/SAWP/592378/2013","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-mcp-mod-efficient-statistical-methodology-model-based-design-and-analysis-phase-ii-dose-finding-studies-under-model-uncertainty_en.pdf"},
    {"id":"34926","name":"Concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-05-19 - 2011-08-31","first_published_date":"2011-06-06T04:00:00Z","last_updated_date":"2011-06-06T04:00:00Z","reference_number":"EMA/CHMP/BWP/25360/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-process-validation-medicinal-products-containing-biotechnology-derived-proteins-active-substance_en.pdf"},
    {"id":"34944","name":"Overview of comments received on draft guideline on real-time release testing (formerly guideline on parametric release)","type":"other","status":"unknown","consultation_date":"2012-03-15 - 2012-10-31","first_published_date":"2012-04-13T15:50:00Z","last_updated_date":"2012-04-13T15:50:00Z","reference_number":"EMA/CHMP/QWP/142288/2012","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-real-time-release-testing-formerly-guideline-parametric-release_en.pdf"},
    {"id":"35028","name":"Draft European Union herbal monograph on Pelargonium sidoides DC and / or Pelargonium reniforme Curt., radix","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-10-26 - 2016-01-31","first_published_date":"2015-10-26T02:00:00Z","last_updated_date":"2015-10-26T02:00:00Z","reference_number":"EMA/HMPC/444244/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-pelargonium-sidoides-dc-and-or-pelargonium-reniforme-curt-radix_en.pdf"},
    {"id":"35037","name":"Call for scientific data for use in HMPC assessment work on Pistacia lentiscus, resinum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-02-15 - 2014-05-15","first_published_date":"2014-02-14T18:30:00Z","last_updated_date":"2014-02-14T18:30:00Z","reference_number":"EMA/HMPC/87630/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-pistacia-lentiscus-resinum_en.pdf"},
    {"id":"35057","name":"Draft list of references supporting the assessment of Tilia tomentosa Moench, flos","type":"herbal-references","status":"Draft","consultation_date":"2011-09-13 - 2012-02-15","first_published_date":"2011-10-20T04:00:00Z","last_updated_date":"2011-10-20T04:00:00Z","reference_number":"EMA/HMPC/346776/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-tilia-tomentosa-moench-flos_en.pdf"},
    {"id":"35144","name":"Draft reflection paper on ethanol content in herbal medicinal products and traditional herbal medicinal products used in children","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2008-11-06 - 2009-03-15","first_published_date":"2008-11-06T02:00:00Z","last_updated_date":"2008-11-06T02:00:00Z","reference_number":"EMA/HMPC/85114/2008","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-ethanol-content-herbal-medicinal-products-and-traditional-herbal-medicinal-products-used-children_en.pdf"},
    {"id":"35202","name":"Concept paper on the revision of the guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-31 - 2011-09-15","first_published_date":"2011-06-01T04:00:00Z","last_updated_date":"2011-06-01T04:00:00Z","reference_number":"EMA/HMPC/111298/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"35207","name":"Draft Community herbal monograph on Origanum dictamnus L., herba - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2012-12-15 - 2013-04-15","first_published_date":"2013-02-04T13:35:00Z","last_updated_date":"2013-02-04T13:35:00Z","reference_number":"EMA/HMPC/200429/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-origanum-dictamnus-l-herba-first-version_en.pdf"},
    {"id":"35215","name":"Draft public statement on Tilia tomentosa Moench, flos","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-09-13 - 2012-02-15","first_published_date":"2011-10-20T04:00:00Z","last_updated_date":"2011-10-20T04:00:00Z","reference_number":"EMA/HMPC/510064/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-tilia-tomentosa-moench-flos_en.pdf"},
    {"id":"35263","name":"Draft list of references supporting the assessment of Thymus vulgaris L. and Thymus zygis L., herba and Primula veris L. and Primula elatior (L.) Hill, radix","type":"herbal-references","status":"Draft","consultation_date":"2011-05-15 - 2011-08-15","first_published_date":"2011-05-30T04:00:00Z","last_updated_date":"2015-02-10T02:00:00Z","reference_number":"EMA/HMPC/85125/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-thymus-vulgaris-l-and-thymus-zygis-l-herba-and-primula-veris-l-and-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"35335","name":"Concept paper on the need for a guideline on the use of subgroup analyses in randomised controlled trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-07-31","first_published_date":"2010-04-30T04:00:00Z","last_updated_date":"2010-04-30T04:00:00Z","reference_number":"EMA/CHMP/EWP/117211/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-use-subgroup-analyses-randomised-controlled-trials_en.pdf"},
    {"id":"35445","name":"Call for scientific data for the systematic review of the monograph on Valeriana officinalis L., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558991/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-valeriana-officinalis-l-radix_en.pdf-0"},
    {"id":"35448","name":"Draft reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-23 - 2010-12-31","first_published_date":"2010-10-13T04:00:00Z","last_updated_date":"2010-10-13T04:00:00Z","reference_number":"EMA/CHMP/QWP/574767/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-pharmaceutical-development-intravenous-medicinal-products-containing-active-substances-solubilised-micellar-systems-non-polymeric-surfactants_en.pdf"},
    {"id":"35469","name":"Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products - Revision 1","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2012-08-08 - 2012-10-15","first_published_date":"2012-08-08T13:10:00Z","last_updated_date":"2012-08-08T13:10:00Z","reference_number":"EMA/HMPC/71049/2007 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"35503","name":"Concept paper on the development of product-specific guidance on demonstration of bioequivalence","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-08-01 - 2013-09-30","first_published_date":"2013-08-01T20:00:00Z","last_updated_date":"2013-08-01T20:00:00Z","reference_number":"EMA/CHMP/423137/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-product-specific-guidance-demonstration-bioequivalence_en.pdf"},
    {"id":"35532","name":"Questions and answers on Benzyl alcohol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-02-24 - 2014-05-31","first_published_date":"2014-02-24T12:00:00Z","last_updated_date":"2014-02-24T12:00:00Z","reference_number":"EMA/CHMP/508188/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-benzyl-alcohol-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"35572","name":"Concept paper on the need for a guideline on clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with atrial fibrillation","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-17 - 2011-05-31","first_published_date":"2011-04-07T04:00:00Z","last_updated_date":"2011-04-07T04:00:00Z","reference_number":"EMA/CHMP/68875/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-guideline-clinical-investigation-medicinal-products-prevention-stroke-and-systemic-embolic-events-patients-atrial-fibrillation_en.pdf"},
    {"id":"35737","name":"Concept paper on the need to revise appendix 4 (on condition-specific guidance) to the guideline on the evaluation of anticancer medicinal products in man - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-01 - 2017-06-30","first_published_date":"2017-03-31T21:11:00Z","last_updated_date":"2017-03-31T21:11:00Z","reference_number":"EMA/102314/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-appendix-4-condition-specific-guidance-guideline-evaluation-anticancer-medicinal-products-man-revision-3_en.pdf"},
    {"id":"35755","name":"International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) topic GL23(R): Studies to evaluate the safety of residues of veterinary drugs in human food: G...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-18 - 2013-03-31","first_published_date":"2013-01-18T11:00:00Z","last_updated_date":"2013-01-18T11:00:00Z","reference_number":"EMA/CVMP/SWP/398880/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/international-cooperation-harmonisation-technical-requirements-registration-veterinary-medicinal-products-vich-topic-gl23r-studies-evaluate-safety-residues-veterinary-drugs-human-food-g_en.pdf"},
    {"id":"35803","name":"Draft guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-27 - 2016-10-31","first_published_date":"2016-04-27T13:05:00Z","last_updated_date":"2016-04-27T13:05:00Z","reference_number":"EMA/CHMP/207892/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-new-medicinal-products-treatment-acute-coronary-syndrome-first-version_en.pdf"},
    {"id":"35841","name":"Concept paper for a guideline on antimicrobial-resistance risk assessment","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-01-18 - 2013-04-30","first_published_date":"2013-01-18T11:00:00Z","last_updated_date":"2013-01-18T11:00:00Z","reference_number":"EMA/CVMP/680258/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-antimicrobial-resistance-risk-assessment_en.pdf"},
    {"id":"35873","name":"Draft guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-25 - 2013-10-01","first_published_date":"2013-03-25T11:30:00Z","last_updated_date":"2013-03-25T11:30:00Z","reference_number":"EMA/CHMP/BWP/85290/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-declaration-quantitative-composition-labelling-biological-medicinal-products-contain-modified-proteins-active-substance_en.pdf"},
    {"id":"35877","name":"Draft public statement on Withania somnifera (L.) Dunal, radix - First version","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2012-12-15 - 2013-04-15","first_published_date":"2012-12-10T18:01:00Z","last_updated_date":"2012-12-10T18:01:00Z","reference_number":"EMA/HMPC/681519/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-withania-somnifera-l-dunal-radix-first-version_en.pdf"},
    {"id":"35880","name":"Draft concept paper on guidance on statistical principles for clinical trials for immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-12-18 - 2016-03-31","first_published_date":"2015-12-18T11:00:01Z","last_updated_date":"2016-01-15T16:35:00Z","reference_number":"EMA/CVMP/IWP/309514/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-guidance-statistical-principles-clinical-trials-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"35906","name":"Draft guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-07 - 2013-08-05","first_published_date":"2013-06-07T14:30:00Z","last_updated_date":"2013-06-07T14:30:00Z","reference_number":"EMA/873138/2011 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-vi-management-and-reporting-adverse-reactions-medicinal-products-rev-1_en.pdf"},
    {"id":"35911","name":"Draft prasugrel film-coated tablets 5 and 10 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-15 - 2015-11-01","first_published_date":"2015-07-15T14:00:01Z","last_updated_date":"2015-07-15T14:00:01Z","reference_number":"EMA/CHMP/PKWP/36761/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-prasugrel-film-coated-tablets-5-and-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"36039","name":"Draft guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2007-02-01 - 2007-08-01","first_published_date":"2007-02-08T02:00:00Z","last_updated_date":"2007-02-08T02:00:00Z","reference_number":"EMEA/CHMP/GTWP/125491/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-scientific-requirements-environmental-risk-assessment-gene-therapy-medicinal-products_en.pdf"},
    {"id":"36082","name":"Draft Community herbal monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-monograph","status":"Draft","consultation_date":"2013-03-12 - 2013-07-15","first_published_date":"2013-04-19T04:00:00Z","last_updated_date":"2013-04-19T04:00:00Z","reference_number":"EMA/HMPC/283630/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"36087","name":"Call for scientific data for the systematic review of the monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2013-02-15 - 2013-05-15","first_published_date":"2013-02-14T18:00:00Z","last_updated_date":"2013-02-14T18:00:00Z","reference_number":"EMA/HMPC/91103/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-foeniculum-vulgare-miller-subsp-vulgare-var-vulgare-fructus_en.pdf"},
    {"id":"36113","name":"Draft concept paper on the need for revision of the guideline on the clinical investigation of plasma-derived fibrin sealant / haemostatic products and the related core summary of product characteristics","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-06-01 - 2014-08-31","first_published_date":"2014-05-28T13:30:00Z","last_updated_date":"2014-05-28T13:30:00Z","reference_number":"EMA/CHMP/BPWP/572810/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-guideline-clinical-investigation-plasma-derived-fibrin-sealant-haemostatic-products-and-related-core-summary-product-characteristics_en.pdf"},
    {"id":"36171","name":"Draft ibuprofen 200 - 800 mg oral use, immediate release formulations product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-03 - 2017-10-31","first_published_date":"2017-08-03T18:30:01Z","last_updated_date":"2017-08-03T18:30:01Z","reference_number":"EMA/CHMP/356876/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ibuprofen-200-800-mg-oral-use-immediate-release-formulations-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"36210","name":"Draft public statement on Syzygium aromaticum (L.) Merill et L.M. Perry, flos","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2011-04-15 - 2011-08-15","first_published_date":"2011-04-20T04:00:00Z","last_updated_date":"2011-04-20T04:00:00Z","reference_number":"EMA/HMPC/112102/2011","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-syzygium-aromaticum-l-merill-et-lm-perry-flos_en.pdf"},
    {"id":"36211","name":"Draft list of references supporting the assessment of Viola tricolor L.","type":"herbal-references","status":"Draft","consultation_date":"2010-05-15 - 2010-08-15","first_published_date":"2010-05-28T04:00:00Z","last_updated_date":"2010-05-28T04:00:00Z","reference_number":"EMA/HMPC/131736/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-viola-tricolor-l_en.pdf"},
    {"id":"36400","name":"Call for scientific data for use in HMPC assessment work on Equisetum arvense L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-07-23 - 2014-10-31","first_published_date":"2014-07-24T18:30:00Z","last_updated_date":"2014-07-24T18:30:00Z","reference_number":"EMA/HMPC/447917/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-equisetum-arvense-l-herba_en.pdf"},
    {"id":"36433","name":"Call for scientific data for the systematic review of the monograph on Primula veris L.; Primula elatior (L.) Hill, radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558987/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-primula-veris-l-primula-elatior-l-hill-radix_en.pdf"},
    {"id":"36474","name":"Concept paper on the need for revision of the note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-08 - 2012-07-31","first_published_date":"2012-06-08T14:20:00Z","last_updated_date":"2012-06-08T14:20:00Z","reference_number":"EMA/CHMP/203926/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-evaluation-pharmacokinetics-medicinal-products-patients-impaired-renal-function_en.pdf"},
    {"id":"36515","name":"Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum – First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/133818/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-hamamelis-virginiana-l-folium-et-cortex-aut-ramunculus-destillatum-first-version_en.pdf"},
    {"id":"36638","name":"Draft reflection paper on the dissolution specification for generic oral immediate release products - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-13 - 2016-08-13","first_published_date":"2016-05-13T17:44:00Z","last_updated_date":"2016-05-13T17:44:00Z","reference_number":"EMA/CHMP/CVMP/QWP/37330/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-dissolution-specification-generic-oral-immediate-release-products-first-version_en.pdf"},
    {"id":"36665","name":"Draft European Union herbal monograph on Carum carvi L. aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2014-12-22 - 2015-03-15","first_published_date":"2014-12-22T18:15:00Z","last_updated_date":"2014-12-22T18:15:00Z","reference_number":"EMA/HMPC/715094/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-carum-carvi-l-aetheroleum_en.pdf"},
    {"id":"36686","name":"Draft reflection paper on the authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-26 - 2016-05-31","first_published_date":"2016-02-26T16:30:00Z","last_updated_date":"2016-02-26T16:30:00Z","reference_number":"EMA/CVMP/448211/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-authorisation-veterinary-medicinal-products-containing-potential-persistent-bioaccumulative-and-toxic-pbt-or-very-persistent-and-very-bioaccumulative-vpvb-substances_en.pdf"},
    {"id":"36784","name":"Call for scientific data for the systematic review of the monograph on Harpagophytum procumbens DC.; Harpagophytum zeyheri Decne, radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-02-09 - 2015-05-15","first_published_date":"2015-02-09T12:45:00Z","last_updated_date":"2015-02-09T12:45:00Z","reference_number":"EMA/HMPC/79054/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-harpagophytum-procumbens-dc-harpagophytum-zeyheri-decne-radix_en.pdf"},
    {"id":"36817","name":"Draft International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products GL52 on bioequivalence: blood-level bioequivalence study","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-12-16 - 2014-05-31","first_published_date":"2013-12-16T19:30:00Z","last_updated_date":"2013-12-16T19:30:00Z","reference_number":"EMA/CVMP/VICH/751935/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-international-cooperation-harmonisation-technical-requirements-registration-veterinary-medicinal-products-gl52-bioequivalence-blood-level-bioequivalence-study_en.pdf"},
    {"id":"36891","name":"Concept paper on a guideline on the evaluation of medicinal products indicated for treatment of influenza","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-05-04 - 2017-07-31","first_published_date":"2017-05-04T18:29:00Z","last_updated_date":"2017-05-04T18:29:00Z","reference_number":"EMA/CHMP/EWP/808940/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-evaluation-medicinal-products-indicated-treatment-influenza_en.pdf"},
    {"id":"36978","name":"Draft guideline on the clinical development of medicinal products intended for the treatment of pain - Second draft","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-12-21 - 2016-03-31","first_published_date":"2015-12-21T13:05:00Z","last_updated_date":"2015-12-21T13:05:00Z","reference_number":"EMA/CHMP/970057/2011 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-development-medicinal-products-intended-treatment-pain-second-draft_en.pdf"},
    {"id":"36990","name":"Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-02-17 - 2011-05-17","first_published_date":"2011-03-14T02:00:00Z","last_updated_date":"2011-03-14T02:00:00Z","reference_number":"EMA/CHMP/BWP/776563/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-potency-declaration-labelling-biological-medicinal-products-which-contain-modified-proteins-active-substance_en.pdf"},
    {"id":"36997","name":"Draft community herbal monograph on Filipendula ulmaria (L.) Maxim. (= Spiraea ulmaria (L.)), flos - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-01-15 - 2011-04-15","first_published_date":"2011-01-26T02:00:00Z","last_updated_date":"2011-01-26T02:00:00Z","reference_number":"EMA/HMPC/434894/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-filipendula-ulmaria-l-maxim-spiraea-ulmaria-l-flos-first-version_en.pdf"},
    {"id":"37118","name":"Call for scientific data for use in HMPC assessment work on Gentiana lutea L., radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-07-23 - 2014-10-31","first_published_date":"2014-07-24T18:30:00Z","last_updated_date":"2014-07-24T18:30:00Z","reference_number":"EMA/HMPC/447918/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-gentiana-lutea-l-radix-revision-1_en.pdf"},
    {"id":"37142","name":"Draft Assessment report on Arctostaphylos uvae ursi (L.) Spreng, folium","type":"herbal-report","status":"Draft","consultation_date":"2010-08-15 - 2010-12-15","first_published_date":"2010-08-18T04:00:00Z","last_updated_date":"2010-08-18T04:00:00Z","reference_number":"EMA/HMPC/573462/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-arctostaphylos-uvae-ursi-l-spreng-folium_en.pdf"},
    {"id":"37180","name":"Draft community herbal monograph on Leonurus cardiaca L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-05-15 - 2010-08-15","first_published_date":"2010-05-26T04:00:00Z","last_updated_date":"2010-05-26T04:00:00Z","reference_number":"EMA/HMPC/127428/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-leonurus-cardiaca-l-herba_en.pdf"},
    {"id":"37199","name":"Concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2011-12-31","first_published_date":"2011-10-12T15:35:00Z","last_updated_date":"2011-10-12T15:35:00Z","reference_number":"EMA/CHMP/BWP/367751/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-quality-porcine-trypsin-used-manufacture-human-biological-medicinal-products_en.pdf"},
    {"id":"37205","name":"Draft questions and answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)","type":"other","status":"Draft: consultation closed","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T14:22:00Z","last_updated_date":"2016-12-15T14:22:00Z","reference_number":"EMA/CHMP/ICH/809509/2016","document_url":"https://www.ema.europa.eu/en/documents/other/draft-questions-and-answers-ich-guideline-q11-development-and-manufacture-drug-substances-chemical-entities-and-biotechnological-biological-entities_en.pdf"},
    {"id":"37220","name":"Draft European Union herbal monograph on Malva sylvestris L. and/or Malva neglecta Wallr., folium - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2018-06-30 - 2018-09-15","first_published_date":"2018-07-02T04:00:00Z","last_updated_date":"2018-07-02T04:00:00Z","reference_number":"EMA/HMPC/749510/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-malva-sylvestris-l-and-or-malva-neglecta-wallr-folium-first-version_en.pdf"},
    {"id":"37251","name":"Draft concept paper on the need for revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-30 - 2015-06-30","first_published_date":"2015-03-30T17:00:00Z","last_updated_date":"2015-03-30T17:00:00Z","reference_number":"EMA/CHMP/QWP/126334/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-guideline-requirements-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-clinical-trials-revision-1_en.pdf"},
    {"id":"37269","name":"Concept paper on the development of a guideline on the demonstration of therapeutic equivalence for locally applied and locally acting products in the gastrointestinal tract - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-10-01 - 2013-12-31","first_published_date":"2013-10-01T16:05:00Z","last_updated_date":"2013-10-01T16:05:00Z","reference_number":"EMA/CHMP/558326/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-demonstration-therapeutic-equivalence-locally-applied-and-locally-acting-products-gastrointestinal-tract-revision-1_en.pdf"},
    {"id":"37272","name":"Draft entecavir film-coated tablets 0.5 and 1 mg, oral solution 0.05mg/ml product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-10-01 - 2016-01-01","first_published_date":"2015-10-06T17:00:00Z","last_updated_date":"2015-10-06T17:00:00Z","reference_number":"EMA/CHMP/PKWP/151748/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-entecavir-film-coated-tablets-05-and-1-mg-oral-solution-005mg-ml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"37304","name":"Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-28 - 2013-09-30","first_published_date":"2013-06-28T18:50:00Z","last_updated_date":"2014-01-16T16:50:01Z","reference_number":"EMA/CHMP/297149/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf"},
    {"id":"37339","name":"Draft community herbal monograph on Vitis vinifera L. var. tinctoria, folium (red vine leaf)","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2009-11-12 - 2010-04-15","first_published_date":"2009-12-21T01:09:21Z","last_updated_date":"2010-01-22T01:00:00Z","reference_number":"EMA/HMPC/16635/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-vitis-vinifera-l-var-tinctoria-folium-red-vine-leaf_en.pdf"},
    {"id":"37354","name":"Draft guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-04-01 - 2015-09-30","first_published_date":"2015-04-01T13:25:00Z","last_updated_date":"2015-04-01T13:25:00Z","reference_number":"EMA/CHMP/41230/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-venous-thromboembolic-disease_en.pdf"},
    {"id":"37356","name":"Draft list of references supporting the assessment of Piper methysticum G. Forst., rhizoma","type":"herbal-references","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:35:00Z","last_updated_date":"2016-12-15T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-piper-methysticum-g-forst-rhizoma_en.pdf"},
    {"id":"37359","name":"Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems","type":"scientific-guideline","status":"Adopted","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-06-25T21:18:20Z","last_updated_date":"2012-06-25T21:18:20Z","reference_number":"EMA/541760/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-and-their-quality-systems_en.pdf"},
    {"id":"37486","name":"Call for scientific data for use in HMPC assessment work on Myroxylon balsamum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2014-07-15 - 2014-10-15","first_published_date":"2014-07-15T13:00:00Z","last_updated_date":"2014-07-15T13:00:00Z","reference_number":"EMA/HMPC/87595/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-myroxylon-balsamum_en.pdf"},
    {"id":"37497","name":"Call for scientific data for use in HMPC assessment work on Menyanthes trifoliata L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/187996/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-menyanthes-trifoliata-l-folium_en.pdf"},
    {"id":"37539","name":"Concept paper on transferring quality control methods validated in collaborative trials to a product / laboratory specific context","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-07-18 - 2014-10-31","first_published_date":"2014-07-18T15:35:00Z","last_updated_date":"2014-07-18T15:35:00Z","reference_number":"CHMP/CVMP/JEG-3Rs/94304/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-transferring-quality-control-methods-validated-collaborative-trials-product-laboratory-specific-context_en.pdf"},
    {"id":"37550","name":"Draft information in the package leaflet for fructose and sorbitol in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev. 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-04 - 2016-08-03","first_published_date":"2016-05-04T17:00:00Z","last_updated_date":"2016-05-04T17:00:00Z","reference_number":"EMA/CHMP/460886/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-fructose-and-sorbitol-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use-cpmp-463-00-rev-1_en.pdf"},
    {"id":"37625","name":"Draft erlotinib product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/418988/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-erlotinib-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"37756","name":"Draft assessment report on Echinacea purpurea (L.) Moench, radix","type":"herbal-report","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:00:00Z","last_updated_date":"2016-12-15T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-echinacea-purpurea-l-moench-radix_en.pdf"},
    {"id":"37785","name":"Call for submission of scientific data on Silybum marianum (L.) Gaertner, fructus: Silybi mariani fructus (milkthistle fruit)","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2010-03-22 - 2010-05-22","first_published_date":"2010-03-22T02:00:00Z","last_updated_date":"2010-03-22T02:00:00Z","reference_number":"EMA/HMPC/152362/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-submission-scientific-data-silybum-marianum-l-gaertner-fructus-silybi-mariani-fructus-milkthistle-fruit_en.pdf"},
    {"id":"37787","name":"Call for scientific data for use in HMPC assessment work on Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558959/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-rosa-centifolia-l-rosa-gallica-l-rosa-damascena-mill-flos_en.pdf"},
    {"id":"37939","name":"Draft ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-31 - 2016-08-31","first_published_date":"2016-05-31T13:25:00Z","last_updated_date":"2016-05-31T13:25:00Z","reference_number":"EMA/CHMP/ICH/320985/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-s3a-note-guidance-toxicokinetics-assessment-systemic-exposure-toxicity-studies-questions-and-answers-first-version_en.pdf"},
    {"id":"38037","name":"Overview of comments received on the second draft Public statement on the use of herbal medicinal products containing toxic unsaturated pyrrolizidine alkaloids (PAs)","type":"comments","status":"unknown","consultation_date":"2014-12-22 - 2015-03-31","first_published_date":"2014-12-22T12:30:00Z","last_updated_date":"2014-12-22T12:30:00Z","reference_number":"EMA/HMPC/577756/2014","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-second-draft-public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas_en.pdf"},
    {"id":"38062","name":"Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-01-06 - 2015-02-07","first_published_date":"2015-01-06T18:00:00Z","last_updated_date":"2015-01-06T18:00:00Z","reference_number":"EMA/CHMP/BPWP/144552/2009 rev 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-ix-products-revision-1_en.pdf"},
    {"id":"38074","name":"European Union individual case safety report (ICSR) implementation guide","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"2014-04-30 - 2014-06-30","first_published_date":"2014-04-30T14:15:00Z","last_updated_date":"2021-04-07T13:35:00Z","reference_number":"EMA/51938/2013 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-union-individual-case-safety-report-icsr-implementation-guide_en.pdf"},
    {"id":"38125","name":"Concept paper on guidance for DNA vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-03-30 - 2012-06-30","first_published_date":"2012-03-30T13:00:00Z","last_updated_date":"2012-03-30T13:00:00Z","reference_number":"EMEA/CHMP/308136/2007","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guidance-dna-vaccines_en.pdf-0"},
    {"id":"38207","name":"Draft public statement on Adhatoda vasica Nees, folium - Revision 1","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2013-01-15 - 2013-04-15","first_published_date":"2013-01-24T02:00:00Z","last_updated_date":"2013-01-24T02:00:00Z","reference_number":"EMA/HMPC/681468/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-adhatoda-vasica-nees-folium-revision-1_en.pdf"},
    {"id":"38226","name":"Concept paper on similar biological product containing recombinant interferon beta","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-03-18 - 2010-06-11","first_published_date":"2010-04-06T04:00:00Z","last_updated_date":"2010-04-06T04:00:00Z","reference_number":"EMA/CHMP/BMWP/86572/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-similar-biological-product-containing-recombinant-interferon-beta_en.pdf"},
    {"id":"38279","name":"Call for scientific data for use in HMPC assessment work on Eschscholtzia californica Cham., herba cum flore","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-04-15","first_published_date":"2012-01-03T11:55:00Z","last_updated_date":"2012-01-03T11:55:00Z","reference_number":"EMA/HMPC/890470/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-eschscholtzia-californica-cham-herba-cum-flore_en.pdf"},
    {"id":"38314","name":"Draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-11-15 - 2017-02-28","first_published_date":"2016-11-15T13:00:00Z","last_updated_date":"2016-11-15T13:00:00Z","reference_number":"EMEA/CHMP/SWP/28367/07 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-strategies-identify-and-mitigate-risks-first-human-and-early-clinical-trials-investigational-medicinal-products-revision-1_en.pdf"},
    {"id":"38359","name":"Draft guideline on good pharmacovigilance practices (GVP) - Module V – Risk management systems (Rev 2)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-29 - 2016-05-31","first_published_date":"2016-02-29T13:00:00Z","last_updated_date":"2016-02-29T13:00:00Z","reference_number":"EMA/838713/2011 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-v-risk-management-systems-rev-2_en.pdf"},
    {"id":"38381","name":"Reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-05-05 - 2011-08-31","first_published_date":"2011-05-17T04:00:00Z","last_updated_date":"2011-05-17T04:00:00Z","reference_number":"EMA/CVMP/ERAWP/409328/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-mitigation-measures-related-environmental-risk-assessment-veterinary-medicinal-products_en.pdf-0"},
    {"id":"38385","name":"Concept paper on the revision of the 'Guideline on the environmental risk assessment of medicinal products for human use' - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-05-04 - 2016-10-31","first_published_date":"2016-05-04T13:00:00Z","last_updated_date":"2016-05-04T13:00:00Z","reference_number":"EMA/CHMP/SWP/65429/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-environmental-risk-assessment-medicinal-products-human-use-first-version_en.pdf"},
    {"id":"38398","name":"Draft inventory of paediatric medicines - Cardiovascular therapeutic area","type":"other","status":"Draft: consultation closed","consultation_date":"2012-08-30 - 2012-10-30","first_published_date":"2012-08-30T21:38:25Z","last_updated_date":"2012-08-30T21:38:25Z","reference_number":"EMA/550070/2012","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-medicines-cardiovascular-therapeutic-area_en.pdf"},
    {"id":"38480","name":"Draft Community herbal monograph on Achillea millefolium L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-11-15 - 2011-02-15","first_published_date":"2010-11-09T02:00:00Z","last_updated_date":"2010-11-09T02:00:00Z","reference_number":"EMA/HMPC/290284/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-achillea-millefolium-l-herba_en.pdf"},
    {"id":"38554","name":"First draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-12-14 - 2013-06-30","first_published_date":"2012-12-14T18:24:00Z","last_updated_date":"2012-12-14T18:24:00Z","reference_number":"EMEA/CHMP/BMWP/32775/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/first-draft-guideline-non-clinical-and-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-insulin-and-insulin-analogues_en.pdf"},
    {"id":"38583","name":"Position paper on potential medication errors in the context of benefit-risk balance and risk minimisation measures","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-06-01 - 2012-11-30","first_published_date":"2012-06-01T19:00:00Z","last_updated_date":"2012-06-01T19:00:00Z","reference_number":"EMA/274183/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-potential-medication-errors-context-benefit-risk-balance-and-risk-minimisation-measures_en.pdf-0"},
    {"id":"38728","name":"Draft paliperidone palmitate depot suspension for injection 25, 50, 75, 100 and 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-10-31","first_published_date":"2016-08-01T17:00:00Z","last_updated_date":"2016-08-01T17:00:00Z","reference_number":"EMA/CHMP/474825/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paliperidone-palmitate-depot-suspension-injection-25-50-75-100-and-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"38766","name":"Draft inventory of paediatric therapeutic needs - Neurology","type":"other","status":"Draft: consultation closed","consultation_date":"2014-05-09 - 2014-07-09","first_published_date":"2014-05-08T13:30:00Z","last_updated_date":"2014-05-08T13:30:00Z","reference_number":"EMA/562919/2013","document_url":"https://www.ema.europa.eu/en/documents/other/draft-inventory-paediatric-therapeutic-needs-neurology_en.pdf"},
    {"id":"38775","name":"Concept paper on the need for revision of the guideline on non-clinical local tolerance testing of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-07-21 - 2011-10-30","first_published_date":"2011-07-26T04:00:00Z","last_updated_date":"2011-07-26T04:00:00Z","reference_number":"EMA/CHMP/SWP/708666/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-non-clinical-local-tolerance-testing-medicinal-products_en.pdf"},
    {"id":"38800","name":"Draft European Union herbal monograph on Salvia officinalis L., folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2016-02-15 - 2016-05-15","first_published_date":"2016-02-15T13:00:00Z","last_updated_date":"2016-02-15T13:00:00Z","reference_number":"EMA/HMPC/277152/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-salvia-officinalis-l-folium_en.pdf"},
    {"id":"38840","name":"Draft guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-04-12 - 2013-06-12","first_published_date":"2013-04-12T19:55:00Z","last_updated_date":"2013-04-12T19:55:00Z","reference_number":"EMA/488220/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-product-or-population-specific-considerations-i-vaccines-prophylaxis-against-infectious-diseases_en.pdf"},
    {"id":"38845","name":"Draft Community herbal monograph on Fucus vesiculosus L., thallus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-08-19 - 2013-11-15","first_published_date":"2013-08-19T04:00:00Z","last_updated_date":"2013-08-19T04:00:00Z","reference_number":"EMA/HMPC/313674/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-fucus-vesiculosus-l-thallus_en.pdf"},
    {"id":"38848","name":"Quality review of documents (QRD) template ‘Particulars to appear on the immediate package – combined label and package leaflet’ for veterinary medicinal products authorised via the centralised, mutual recognition and de...","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-03 - 2018-10-31","first_published_date":"2017-04-03T21:20:00Z","last_updated_date":"2017-04-03T21:20:00Z","reference_number":"EMA/195158/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quality-review-documents-qrd-template-particulars-appear-immediate-package-combined-label-and-package-leaflet-veterinary-medicinal-products-authorised-centralised-mutual-recognition-and-de_en.pdf"},
    {"id":"38878","name":"Draft community herbal monograph on Cinnamomum verum J.S. Presl (Cinnamomum zeylanicum Nees), aetheroleum","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-08-15 - 2010-12-15","first_published_date":"2010-08-20T04:00:00Z","last_updated_date":"2010-08-20T04:00:00Z","reference_number":"EMA/HMPC/706229/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-cinnamomum-verum-js-presl-cinnamomum-zeylanicum-nees-aetheroleum_en.pdf"},
    {"id":"38907","name":"Call for scientific data for the periodic review of the monograph on Solidago virgaurea L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/188895/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-solidago-virgaurea-l-herba_en.pdf"},
    {"id":"38931","name":"Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-08 - 2016-10-14","first_published_date":"2016-08-08T19:00:00Z","last_updated_date":"2016-08-08T19:00:00Z","reference_number":"EMA/209012/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-gvp-module-ix-addendum-i-methodological-aspects-signal-detection-spontaneous-reports-suspected-adverse-reactions_en.pdf"},
    {"id":"38944","name":"Concept paper on the need to revise the points to consider on adjustment for baseline covariates","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-29 - 2012-05-30","first_published_date":"2012-02-29T11:15:00Z","last_updated_date":"2012-02-29T11:15:00Z","reference_number":"EMA/CHMP/965150/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-points-consider-adjustment-baseline-covariates_en.pdf"},
    {"id":"38986","name":"Draft guideline on the use of pharmacogenetic methodologies in the  pharmacokinetic evaluation of medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-04-22 - 2010-10-31","first_published_date":"2010-05-06T04:00:00Z","last_updated_date":"2010-05-06T04:00:00Z","reference_number":"EMA/CHMP/37646/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-pharmacogenetic-methodologies-pharmacokinetic-evaluation-medicinal-products_en.pdf"},
    {"id":"38995","name":"Concept paper on the development of a CHMP guideline on the non-clinical requirements to support early phase I clinical trials with pharmaceutical compounds","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2006-03-23 - 2006-06-30","first_published_date":"2006-03-23T02:00:00Z","last_updated_date":"2006-03-23T02:00:00Z","reference_number":"EMEA/CHMP/SWP/91850/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-chmp-guideline-non-clinical-requirements-support-early-phase-i-clinical-trials-pharmaceutical-compounds_en.pdf"},
    {"id":"39133","name":"Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘loss of appetite’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2017-02-28 - 2017-05-31","first_published_date":"2017-03-06T16:00:00Z","last_updated_date":"2017-03-06T16:00:00Z","reference_number":"EMA/HMPC/133334/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-herbal-tea-combinations-traditionally-used-therapeutic-area-loss-appetite_en.pdf"},
    {"id":"39182","name":"Draft guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-03 - 2016-07-31","first_published_date":"2016-02-03T13:00:00Z","last_updated_date":"2016-02-03T13:00:00Z","reference_number":"EMA/CVMP/QWP/128710/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market_en.pdf"},
    {"id":"39209","name":"Draft reflection paper on poorly extractable and or non-radiolabelled substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-20 - 2015-08-31","first_published_date":"2015-03-20T17:00:00Z","last_updated_date":"2015-03-20T17:00:00Z","reference_number":"EMA/CVMP/ERA/349254/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-poorly-extractable-and-or-non-radiolabelled-substances_en.pdf"},
    {"id":"39216","name":"Draft guideline on good pharmacovigilance practices: Module IX - Signal management","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-02-21 - 2012-04-18","first_published_date":"2012-02-22T14:20:00Z","last_updated_date":"2012-02-22T14:20:00Z","reference_number":"EMA/827661/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-ix-signal-management_en.pdf"},
    {"id":"39222","name":"Call for scientific data for the systematic review of the monograph on Aloe barbadensis Miller; Aloe ferox Miller","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648278/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-aloe-barbadensis-miller-aloe-ferox-miller_en.pdf"},
    {"id":"39278","name":"Draft European Union herbal monograph on Allium sativum L., bulbus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2016-07-25 - 2016-10-31","first_published_date":"2016-07-25T19:00:00Z","last_updated_date":"2016-07-25T19:00:00Z","reference_number":"EMA/HMPC/7685/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-allium-sativum-l-bulbus_en.pdf"},
    {"id":"39304","name":"Draft ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-31 - 2018-04-30","first_published_date":"2018-01-31T14:15:00Z","last_updated_date":"2018-01-31T14:15:00Z","reference_number":"EMA/CHMP/800789/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ledipasvir-sofosbuvir-film-coated-tablet-90-mg-400-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"39391","name":"Draft guideline on user safety of topically administered veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-06-27 - 2016-12-31","first_published_date":"2016-06-27T19:40:00Z","last_updated_date":"2016-06-27T19:40:00Z","reference_number":"EMA/CVMP/SWP/721059/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-user-safety-topically-administered-veterinary-medicinal-products_en.pdf"},
    {"id":"39463","name":"Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 1 and 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-12-15 - 2013-03-15","first_published_date":"2012-12-14T18:30:00Z","last_updated_date":"2013-01-31T16:35:00Z","reference_number":"EMA/CHMP/718840/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders-revision-1-and-2_en.pdf"},
    {"id":"39552","name":"Concept paper on the need to revise the guideline on the clinical development of fixed-dose combinations of medicinal products regarding dossier content requirements - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-03-01 - 2013-05-31","first_published_date":"2013-03-01T12:00:00Z","last_updated_date":"2013-03-01T12:00:00Z","reference_number":"EMA/CHMP/779887/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-guideline-clinical-development-fixed-dose-combinations-medicinal-products-regarding-dossier-content-requirements-revision-2_en.pdf"},
    {"id":"39652","name":"Draft guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-01 - 2016-04-30","first_published_date":"2016-02-01T17:46:01Z","last_updated_date":"2016-02-01T17:46:01Z","reference_number":"EMA/CHMP/39283/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-nanocolloidal-technetium-99mtc-albumin_en.pdf"},
    {"id":"39677","name":"Draft CVMP reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-07-17 - 2016-01-31","first_published_date":"2015-07-17T13:15:00Z","last_updated_date":"2015-07-17T13:15:00Z","reference_number":"EMA/CVMP/IWP/251741/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-cvmp-reflection-paper-methods-found-suitable-within-eu-demonstrating-freedom-extraneous-agents-seeds-used-production-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"39679","name":"Guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease","type":"scientific-guideline","status":"Adopted","consultation_date":"2009-12-17 - 2010-06-30","first_published_date":"2011-03-14T02:00:00Z","last_updated_date":"2011-03-14T02:00:00Z","reference_number":"EMA/CHMP/EWP/342691/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-drugs-treatment-gastro-oesophageal-reflux-disease_en.pdf"},
    {"id":"39686","name":"Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-07-04 - 2013-12-31","first_published_date":"2013-07-04T14:00:00Z","last_updated_date":"2013-07-04T14:00:00Z","reference_number":"EMA/CHMP/QWP/324350/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-note-guidance-manufacture-finished-dosage-form-revision-1_en.pdf"},
    {"id":"39691","name":"Draft reflection paper on testing strategy and risk assessment for plants","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-03-09 - 2011-06-30","first_published_date":"2011-03-29T04:00:00Z","last_updated_date":"2011-03-29T04:00:00Z","reference_number":"EMA/CVMP/ERA/147844/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-testing-strategy-and-risk-assessment-plants_en.pdf"},
    {"id":"39706","name":"Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-03 - 2017-10-31","first_published_date":"2017-08-03T18:30:00Z","last_updated_date":"2017-08-03T18:30:00Z","reference_number":"EMA/CHMP/421315/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dimethyl-fumarate-gastro-resistant-capsules-120-mg-and-240-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"39725","name":"Call for scientific data for the systematic review of the monograph on Valeriana officinalis L., radix and Humulus lupulus L., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2015-12-15 - 2016-03-15","first_published_date":"2015-12-15T11:00:00Z","last_updated_date":"2015-12-15T11:00:00Z","reference_number":"EMA/HMPC/845014/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-valeriana-officinalis-l-radix-and-humulus-lupulus-l-flos_en.pdf"},
    {"id":"39828","name":"Concept paper on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-29 - 2016-07-31","first_published_date":"2016-04-29T18:25:00Z","last_updated_date":"2016-04-29T18:25:00Z","reference_number":"EMA/CVMP/IWP/867401/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-dna-vaccines-non-amplifiable-eukaryotic-cells-veterinary-use_en.pdf"},
    {"id":"39837","name":"Concept paper on the need for revision of the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-01 - 2013-01-31","first_published_date":"2012-10-31T19:00:00Z","last_updated_date":"2012-10-31T19:00:00Z","reference_number":"EMA/CHMP/520786/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-guideline-evaluation-medicinal-products-treatment-primary-osteoporosis_en.pdf"},
    {"id":"39968","name":"Qualification opinion of low hippocampal volume (atrophy) by magnetic-resonance imaging for use in regulatory clinical trials in predementia stage of Alzheimer’s disease","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2011-11-01","first_published_date":"2011-10-12T19:55:38Z","last_updated_date":"2011-10-12T19:55:38Z","reference_number":"EMA/CHMP/SAWP/102001/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualification-opinion-low-hippocampal-volume-atrophy-magnetic-resonance-imaging-use-regulatory-clinical-trials-predementia-stage-alzheimers-disease_en.pdf"},
    {"id":"40002","name":"Draft European Union herbal monograph on Echinacea purpurea (L.) Moench, radix","type":"herbal-references","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:00:00Z","last_updated_date":"2016-12-15T11:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-european-union-herbal-monograph-echinacea-purpurea-l-moench-radix_en.pdf"},
    {"id":"40013","name":"Call for scientific data for the systematic review of the monograph on Rhamnus frangula L., cortex","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648280/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-rhamnus-frangula-l-cortex_en.pdf"},
    {"id":"40046","name":"Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-16 - 2017-11-17","first_published_date":"2017-10-16T13:28:00Z","last_updated_date":"2017-10-16T13:28:00Z","reference_number":"EMA/CVMP/QWP/631010/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-implementation-risk-assessment-requirements-control-elemental-impurities-veterinary-medicinal-products-first-version_en.pdf"},
    {"id":"40062","name":"Draft guideline on active substance master file procedure - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-01-12 - 2012-03-12","first_published_date":"2012-01-19T17:30:00Z","last_updated_date":"2012-01-19T17:30:00Z","reference_number":"CHMP/QWP/227/02 Rev 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-active-substance-master-file-procedure-revision-3_en.pdf"},
    {"id":"40073","name":"Call for scientific data for use in HMPC assessment work on Angelica sinensis (Oliv.) Diels, radix - First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-12-15 - 2012-04-15","first_published_date":"2012-01-03T12:07:00Z","last_updated_date":"2012-01-03T12:07:00Z","reference_number":"EMA/HMPC/890469/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
    {"id":"40105","name":"Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-06-17 - 2014-11-30","first_published_date":"2014-06-17T18:15:00Z","last_updated_date":"2014-06-17T18:15:00Z","reference_number":"EMA/CHMP/292464/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-patient-reported-outcome-pro-measures-oncology-studies_en.pdf"},
    {"id":"40106","name":"Draft guideline on stability testing for applications for variations to a marketing authorisation - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-07-13 - 2012-01-31","first_published_date":"2011-07-26T04:00:00Z","last_updated_date":"2011-07-26T04:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/441071/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-stability-testing-applications-variations-marketing-authorisation-revision-2_en.pdf"},
    {"id":"40115","name":"Draft guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-11 - 2016-04-30","first_published_date":"2016-02-11T11:55:00Z","last_updated_date":"2016-02-11T11:55:00Z","reference_number":"EMA/CHMP/BPWP/319619/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-anti-d-immunoglobulin-intravenous-use_en.pdf"},
    {"id":"40122","name":"Draft ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population, step 2b - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-10-13 - 2017-04-13","first_published_date":"2016-10-13T19:03:00Z","last_updated_date":"2016-10-13T19:03:00Z","reference_number":"EMA/CPMP/ICH/2711/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population-step-2b-revision-1_en.pdf"},
    {"id":"40150","name":"Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-05-15 - 2014-11-15","first_published_date":"2014-05-15T13:50:00Z","last_updated_date":"2014-05-15T13:50:00Z","reference_number":"EMA/CHMP/239770/2014 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis-revision-2_en.pdf"},
    {"id":"40175","name":"Call for scientific data for use in HMPC assessment work on Eucalyptus globulus Labill., E. polybractea R.T. Baker and E. smithii R.T. Baker., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-06-01 - 2011-09-15","first_published_date":"2011-06-07T04:00:00Z","last_updated_date":"2011-06-07T04:00:00Z","reference_number":"EMA/HMPC/422012/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-eucalyptus-globulus-labill-e-polybractea-rt-baker-and-e-smithii-rt-baker-aetheroleum_en.pdf"},
    {"id":"40187","name":"Draft guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-11-16 - 2013-05-31","first_published_date":"2012-11-19T12:30:00Z","last_updated_date":"2012-11-19T12:30:00Z","reference_number":"EMA/CVMP/EWP/1061/2001-CONSULTATION","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs_en.pdf"},
    {"id":"40218","name":"Concept paper on the need for revision of note for guidance on clinical medicinal products for treatment of nociceptive pain and guideline on clinical investigation of products intended for the treatment of neuropathic p...","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2011-09-22 - 2011-12-31","first_published_date":"2011-09-29T17:55:00Z","last_updated_date":"2011-09-29T17:55:00Z","reference_number":"EMA/CHMP/210477/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-medicinal-products-treatment-nociceptive-pain-and-guideline-clinical-investigation-products-intended-treatment-neuropathic-p_en.pdf"},
    {"id":"40245","name":"Draft guideline on core SmPC and package leaflet for (99Mo/99mTc) generator","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-01-29 - 2014-04-15","first_published_date":"2014-01-29T02:00:00Z","last_updated_date":"2014-01-29T02:00:00Z","reference_number":"EMA/773757/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-and-package-leaflet-99mo-99mtc-generator_en.pdf"},
    {"id":"40282","name":"ICH guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"2012-12-17 - 2013-04-01","first_published_date":"2012-12-17T15:55:00Z","last_updated_date":"2016-03-02T13:25:00Z","reference_number":"EMA/CHMP/ICH/536328/2013 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ich-guideline-s1-regulatory-notice-changes-core-guideline-rodent-carcinogenicity-testing-pharmaceuticals_en.pdf"},
    {"id":"40309","name":"Draft carglumic acid product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/422457/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-carglumic-acid-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"40349","name":"Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium – First version","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-01 - 2018-05-31","first_published_date":"2018-03-01T19:00:00Z","last_updated_date":"2018-03-01T19:00:00Z","reference_number":"EMA/HMPC/129591/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-hamamelis-virginiana-l-folium-first-version_en.pdf"},
    {"id":"40373","name":"Draft apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-27 - 2018-09-30","first_published_date":"2018-06-27T14:30:00Z","last_updated_date":"2018-06-27T14:30:00Z","reference_number":"EMA/CHMP/291499/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-apixaban-film-coated-tablet-25-and-5-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"40402","name":"Call for scientific data for use in HMPC assessment work on Carum carvi L., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-06-15 - 2012-10-15","first_published_date":"2012-06-15T15:30:00Z","last_updated_date":"2012-06-15T15:30:00Z","reference_number":"EMA/HMPC/332752/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-carum-carvi-l-fructus_en.pdf"},
    {"id":"40409","name":"Draft concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-09-17 - 2018-12-16","first_published_date":"2018-09-17T14:00:00Z","last_updated_date":"2018-09-17T14:00:00Z","reference_number":"EMA/PDCO/362462/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-need-revision-guideline-investigation-medicinal-products-term-and-preterm-neonate-revision-1_en.pdf"},
    {"id":"40419","name":"Call for scientific data for the systematic review of the monograph on Ribes nigrum L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-04-15 - 2016-07-15","first_published_date":"2016-04-15T20:00:00Z","last_updated_date":"2016-04-15T20:00:00Z","reference_number":"EMA/269967/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-ribes-nigrum-l-folium_en.pdf"},
    {"id":"40527","name":"Reflection paper on meticillin-resistant Staphylococcus pseudintermedius","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-09-15 - 2010-11-30","first_published_date":"2010-09-27T04:00:00Z","last_updated_date":"2010-09-27T04:00:00Z","reference_number":"EMA/CVMP/SAGAM/736964/2009","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-meticillin-resistant-staphylococcus-pseudintermedius_en.pdf-0"},
    {"id":"40582","name":"Draft guideline on quality of transdermal patches","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2012-09-15 - 2013-03-15","first_published_date":"2012-09-14T14:00:00Z","last_updated_date":"2012-09-14T14:00:00Z","reference_number":"EMA/CHMP/QWP/911254/2011","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-transdermal-patches_en.pdf"},
    {"id":"40611","name":"Draft octreotide acetate depot powder and solvent for suspension for injection 10 mg, 20 mg or 30 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-06-27 - 2018-09-30","first_published_date":"2018-06-27T14:30:00Z","last_updated_date":"2018-06-27T14:30:00Z","reference_number":"EMA/CHMP/291571/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-octreotide-acetate-depot-powder-and-solvent-suspension-injection-10-mg-20-mg-or-30-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"40622","name":"Call for scientific data for the systematic review of the monograph on Primula veris L.; Primula elatior (L.) Hill, flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558987/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-primula-veris-l-primula-elatior-l-hill-flos_en.pdf"},
    {"id":"40681","name":"Draft Community herbal monograph on Achillea millefolium L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2010-11-15 - 2011-02-15","first_published_date":"2010-11-09T02:00:00Z","last_updated_date":"2010-11-09T02:00:00Z","reference_number":"EMA/HMPC/143949/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-achillea-millefolium-l-flos_en.pdf"},
    {"id":"40688","name":"Draft guideline on the use of adjuvanted veterinary vaccines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-07-05 - 2019-01-15","first_published_date":"2018-07-05T18:02:00Z","last_updated_date":"2018-07-05T18:02:00Z","reference_number":"EMA/CVMP/IWP/315887/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-use-adjuvanted-veterinary-vaccines-revision-1_en.pdf"},
    {"id":"40707","name":"Draft community herbal monograph on Fraxinus excelsior L. and Fraxinus angustifolia Vahl, folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-08-15 - 2011-11-15","first_published_date":"2011-08-30T04:00:00Z","last_updated_date":"2011-08-30T04:00:00Z","reference_number":"EMA/HMPC/239271/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-fraxinus-excelsior-l-and-fraxinus-angustifolia-vahl-folium_en.pdf"},
    {"id":"40728","name":"Concept paper on the revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-05-04 - 2017-07-31","first_published_date":"2017-05-04T13:30:00Z","last_updated_date":"2017-05-04T13:30:00Z","reference_number":"EMA/CHMP/448599/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-role-pharmacokinetics-development-medicinal-products-paediatric-population_en.pdf"},
    {"id":"40736","name":"Draft Community herbal monograph on Plantaginis lanceolatae folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2011-01-15 - 2011-04-15","first_published_date":"2011-01-26T02:00:00Z","last_updated_date":"2011-01-26T02:00:00Z","reference_number":"EMA/HMPC/437858/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-plantaginis-lanceolatae-folium_en.pdf"},
    {"id":"40737","name":"Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2016-02-29 - 2016-05-31","first_published_date":"2016-02-29T14:00:00Z","last_updated_date":"2016-02-29T14:00:00Z","reference_number":"EMA/PRAC/613102/2015 Rev.2 accompanying GVP Module","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guidance-format-risk-management-plan-rmp-eu-integrated-format_en.doc"},
    {"id":"40754","name":"CVMP draft strategy on antimicrobials 2011-2015","type":"other","status":"Draft: consultation closed","consultation_date":"2011-01-10 - 2011-03-31","first_published_date":"2011-01-11T01:31:00Z","last_updated_date":"2011-01-11T01:31:00Z","reference_number":"EMA/CVMP/287420/2010","document_url":"https://www.ema.europa.eu/en/documents/other/cvmp-draft-strategy-antimicrobials-2011-2015_en.pdf"},
    {"id":"40774","name":"Call for scientific data for the systematic review of the monograph on Rhamni purshianus D.C., cortex","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2012-10-15 - 2013-02-15","first_published_date":"2012-10-15T14:30:00Z","last_updated_date":"2012-10-15T14:30:00Z","reference_number":"EMA/HMPC/648287/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-rhamni-purshianus-dc-cortex_en.pdf"},
    {"id":"40873","name":"Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-03-06 - 2017-06-06","first_published_date":"2017-03-06T12:40:00Z","last_updated_date":"2017-03-06T12:40:00Z","reference_number":"EMA/CHMP/CVMP/QWP/BWP/428135/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-quality-water-pharmaceutical-use-hv_en.pdf"},
    {"id":"40884","name":"Call for scientific data for use in HMPC assessment work on Salvia miltiorrhiza Bunge, radix et rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2018-03-31 - 2018-06-30","first_published_date":"2018-03-28T19:00:00Z","last_updated_date":"2018-03-28T19:00:00Z","reference_number":"EMA/HMPC/188011/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-salvia-miltiorrhiza-bunge-radix-et-rhizoma_en.pdf"},
    {"id":"40914","name":"Draft guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-22 - 2017-11-30","first_published_date":"2017-08-22T20:00:00Z","last_updated_date":"2017-08-22T20:00:00Z","reference_number":"EMEA/HMPC/32116/2005 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-documentation-applications-marketing-authorisation-registration-well-established-and-traditional-herbal-medicinal-products-revision-1_en.pdf"},
    {"id":"40918","name":"Draft abiraterone tablets 250 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-08-01 - 2016-10-31","first_published_date":"2016-08-01T17:00:00Z","last_updated_date":"2016-08-01T17:00:00Z","reference_number":"EMA/CHMP/474712/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-abiraterone-tablets-250-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"41054","name":"Draft guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-06-07 - 2013-08-05","first_published_date":"2013-06-07T14:30:00Z","last_updated_date":"2013-06-07T14:30:00Z","reference_number":"EMA/204715/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-pharmacovigilance-practices-module-xvi-risk-minimisation-measures-selection-tools-and-effectiveness-indicators_en.pdf"},
    {"id":"41091","name":"Guideline on reporting of suspected transmission of any infectious agent via a medicinal product","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2005-06-01 - 2006-03-31","first_published_date":"2006-01-23T01:00:00Z","last_updated_date":"2006-01-23T01:00:00Z","reference_number":"EMEA/CHMP/296412/2005","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-reporting-suspected-transmission-any-infectious-agent-medicinal-product_en.pdf"},
    {"id":"41093","name":"Draft European Union herbal monograph on Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-07-27 - 2015-10-31","first_published_date":"2015-07-27T15:00:00Z","last_updated_date":"2015-07-27T15:00:00Z","reference_number":"EMA/HMPC/39453/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-sideritis-scardica-griseb-sideritis-clandestina-bory-chaub-hayek-sideritis-raeseri-boiss-heldr-sideritis-syriaca-l-herba_en.pdf"},
    {"id":"41117","name":"Draft list of references supporting the assessment of Vitis\n\nvinifera L., folium","type":"herbal-references","status":"unknown","consultation_date":"2016-12-15 - 2017-03-15","first_published_date":"2016-12-15T11:54:00Z","last_updated_date":"2016-12-15T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-vitis-vinifera-l-folium_en.pdf"},
    {"id":"41129","name":"Draft guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-04-12 - 2017-10-31","first_published_date":"2017-04-24T18:54:00Z","last_updated_date":"2017-04-24T18:54:00Z","reference_number":"EMA/CVMP/EWP/016/00 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-conduct-bioequivalence-studies-veterinary-medicinal-products-revision-3_en.pdf"},
    {"id":"41138","name":"Draft questions and answers on cyclodextrins in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use'","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-12-01 - 2015-02-28","first_published_date":"2014-12-01T19:20:00Z","last_updated_date":"2014-12-01T19:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-questions-and-answers-cyclodextrins-context-revision-guideline-excipients-label-and-package-leaflet-medicinal-products-human-use_en.pdf"},
    {"id":"41205","name":"Call for scientific data for use in HMPC assessment work on Picrorhiza kurroa Royle ex. Benth., rhizoma et radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2011-07-15 - 2011-11-15","first_published_date":"2011-07-18T04:00:00Z","last_updated_date":"2011-07-18T04:00:00Z","reference_number":"EMA/HMPC/558953/2011","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-picrorhiza-kurroa-royle-ex-benth-rhizoma-et-radix_en.pdf"},
    {"id":"41231","name":"Draft guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-04-28 - 2014-07-31","first_published_date":"2014-04-28T14:45:00Z","last_updated_date":"2014-04-28T14:45:00Z","reference_number":"EMA/CHMP/151853/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-role-pathological-complete-response-endpoint-neoadjuvant-breast-cancer-studies_en.pdf"},
    {"id":"41389","name":"Draft public statement on Angelica sinensis (Oliv.) Diels, radix - First version","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2012-12-15 - 2013-04-15","first_published_date":"2012-12-10T18:00:00Z","last_updated_date":"2012-12-10T18:00:00Z","reference_number":"EMA/HMPC/681574/2012","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-angelica-sinensis-oliv-diels-radix-first-version_en.pdf"},
    {"id":"41427","name":"Draft reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-07-25 - 2018-01-31","first_published_date":"2017-07-25T20:30:00Z","last_updated_date":"2017-07-25T20:30:00Z","reference_number":"EMA/CVMP/AWP/237294/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-label-use-antimicrobials-veterinary-medicine-european-union-first-version_en.pdf"},
    {"id":"41428","name":"Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-04-13 - 2016-10-13","first_published_date":"2016-04-13T16:00:00Z","last_updated_date":"2016-04-13T16:00:00Z","reference_number":"EMA/CHMP/CVMP/QWP/BWP/850374/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-sterilisation-medicinal-product-active-substance-excipient-and-primary-container_en.pdf"},
    {"id":"41456","name":"Draft tadalafil product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/423735/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-tadalafil-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"41462","name":"Draft VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-01-26 - 2018-06-15","first_published_date":"2018-01-26T19:30:00Z","last_updated_date":"2018-01-26T19:30:00Z","reference_number":"EMA/CVMP/VICH/517152/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl57-studies-evaluate-metabolism-and-residue-kinetics-veterinary-drugs-food-producing-species-marker-residue-depletion-studies-establish-product-withdrawal-periods-aquatic-species_en.pdf"},
    {"id":"41511","name":"Q3C (R6): Impurities: guideline for residual solvents - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-08-04 - 2015-11-03","first_published_date":"2015-08-04T15:00:00Z","last_updated_date":"2015-08-04T15:00:00Z","reference_number":"EMA/CHMP/ICH/82260/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/q3c-r6-impurities-guideline-residual-solvents-step-2b_en.pdf"},
    {"id":"41555","name":"Call for scientific data for the systematic review of the monograph on Calendula officinalis L., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-06-15 - 2016-09-15","first_published_date":"2016-06-15T13:00:00Z","last_updated_date":"2016-06-15T13:00:00Z","reference_number":"EMA/HMPC/403694/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-calendula-officinalis-l-flos_en.pdf"},
    {"id":"41630","name":"Draft European Union herbal monograph on Polygonum aviculare L., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2015-10-19 - 2016-01-15","first_published_date":"2015-10-19T14:50:00Z","last_updated_date":"2015-10-19T14:50:00Z","reference_number":"EMA/HMPC/143658/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-polygonum-aviculare-l-herba_en.pdf"},
    {"id":"41642","name":"Draft guideline on similar biological medicinal products containing monoclonal antibodies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2010-11-18 - 2011-05-31","first_published_date":"2010-11-26T02:00:00Z","last_updated_date":"2010-11-26T02:00:00Z","reference_number":"EMA/CHMP/BMWP/403543/2010","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-similar-biological-medicinal-products-containing-monoclonal-antibodies_en.pdf"},
    {"id":"41647","name":"Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-05-08 - 2013-10-31","first_published_date":"2013-05-08T14:00:00Z","last_updated_date":"2013-05-08T14:00:00Z","reference_number":"EMA/CHMP/SWP/272921/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-methyl-and-propylparaben-excipients-human-medicinal-products-oral-use_en.pdf"},
    {"id":"41655","name":"Draft Community herbal monograph on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2013-08-21 - 2013-12-15","first_published_date":"2013-08-21T04:00:00Z","last_updated_date":"2013-08-21T04:00:00Z","reference_number":"EMA/HMPC/320930/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-community-herbal-monograph-melaleuca-alternifolia-maiden-and-betch-cheel-m-linariifolia-smith-m-dissitiflora-f-mueller-and-or-other-species-melaleuca-aetheroleum-first-version_en.pdf"},
    {"id":"41679","name":"Concept paper on the need to revise condition–specific guidance, appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-07-31 - 2013-10-31","first_published_date":"2013-07-31T17:55:00Z","last_updated_date":"2013-07-31T17:55:00Z","reference_number":"EMA/CHMP/432831/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revise-condition-specific-guidance-appendix-4-guideline-evaluation-anticancer-medicinal-products-man-revision-1_en.pdf"},
    {"id":"41710","name":"Revised provisional priority list for studies on off-patent paediatric medicinal products","type":"other","status":"Draft: consultation closed","consultation_date":"2013-06-06 - 2013-07-05","first_published_date":"2013-06-05T21:00:00Z","last_updated_date":"2013-06-05T21:00:00Z","reference_number":"EMA/98717/2012 Rev.2013/14","document_url":"https://www.ema.europa.eu/en/documents/other/revised-provisional-priority-list-studies-patent-paediatric-medicinal-products_en.pdf"},
    {"id":"41720","name":"Call for scientific data for the systematic review of the monograph on Avena sativa L., herba and Avena sativa L., fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-06-15 - 2016-09-15","first_published_date":"2016-06-15T13:00:00Z","last_updated_date":"2016-06-15T13:00:00Z","reference_number":"EMA/HMPC/403693/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-avena-sativa-l-herba-and-avena-sativa-l-fructus_en.pdf-0"},
    {"id":"41733","name":"Draft guideline on specifications: test procedures and acceptance criteria for herbal  substances, herbal  preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-08-15 - 2018-11-30","first_published_date":"2018-08-15T20:00:00Z","last_updated_date":"2018-08-15T20:00:00Z","reference_number":"EMA/HMPC/162241/2005","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-specifications-test-procedures-and-acceptance-criteria-herbal-substances-herbal-preparations-and-herbal-medicinal-products-traditional-herbal-medicinal-products-revision-3_en.pdf"},
    {"id":"41750","name":"Concept paper on the need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-31 - 2018-01-31","first_published_date":"2017-10-31T18:00:00Z","last_updated_date":"2017-10-31T18:00:00Z","reference_number":"EMA/230866/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-and-prophylaxis-venous-thromboembolic-disease_en.pdf"},
    {"id":"41763","name":"Stem cell -based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-06-27 - 2016-09-30","first_published_date":"2016-06-27T19:40:00Z","last_updated_date":"2016-06-27T19:40:00Z","reference_number":"EMA/CVMP/ADVENT/174610/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/stem-cell-based-products-veterinary-use-specific-questions-extraneous-agents-be-addressed-ad-hoc-expert-group-veterinary-novel-therapies-advent_en.pdf"},
    {"id":"41783","name":"Draft ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, step 2b - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-08-31 - 2018-02-28","first_published_date":"2017-08-31T13:10:01Z","last_updated_date":"2017-08-31T13:10:01Z","reference_number":"EMA/CHMP/ICH/436221/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e9-r1-addendum-estimands-and-sensitivity-analysis-clinical-trials-guideline-statistical-principles-clinical-trials-step-2b-revision-1_en.pdf"},
    {"id":"41821","name":"Concept paper on revision of guideline on epidemiological data on blood-transmissible infections","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2014-08-01 - 2014-12-31","first_published_date":"2014-08-01T15:00:00Z","last_updated_date":"2014-08-01T15:00:00Z","reference_number":"EMA/CHMP/BWP/295676/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-epidemiological-data-blood-transmissible-infections_en.pdf"},
    {"id":"41834","name":"Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-02-24 - 2017-08-31","first_published_date":"2017-02-24T18:00:00Z","last_updated_date":"2017-02-24T18:00:00Z","reference_number":"EMA/CVMP/SWP/377245/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-assessment-and-control-dna-reactive-mutagenic-impurities-veterinary-medicines_en.pdf"},
    {"id":"41873","name":"Draft European Union herbal monograph on Curcuma longa L. (C. domestica Valeton), rhizome – Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2017-12-15 - 2018-03-15","first_published_date":"2017-12-08T18:35:00Z","last_updated_date":"2017-12-08T18:35:00Z","reference_number":"EMA/HMPC/329755/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-curcuma-longa-l-c-domestica-valeton-rhizome-revision-1_en.pdf"},
    {"id":"41877","name":"Answers to the requests for scientific advice on the impact on public health and animal health of the use of antibiotics in animals","type":"other","status":"Adopted","consultation_date":"2014-08-01 - 2014-09-30","first_published_date":"2014-08-01T16:00:00Z","last_updated_date":"2014-12-19T16:00:00Z","reference_number":"EMA/381884/2014","document_url":"https://www.ema.europa.eu/en/documents/other/answers-requests-scientific-advice-impact-public-health-and-animal-health-use-antibiotics-animals_en.pdf"},
    {"id":"41926","name":"Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 2b - Annexes - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-12-18 - 2018-12-18","first_published_date":"2017-12-18T18:00:00Z","last_updated_date":"2017-12-18T18:00:00Z","reference_number":"EMA/CHMP/ICH/804273/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q12-technical-and-regulatory-considerations-pharmaceutical-product-lifecycle-management-step-2b-annexes-first-version_en.pdf"},
    {"id":"41941","name":"Draft repaglinide product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2013-11-15 - 2014-02-15","first_published_date":"2013-11-15T16:00:00Z","last_updated_date":"2013-11-15T16:00:00Z","reference_number":"CHMP/PKWP/EMA/422421/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-repaglinide-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"41959","name":"Call for scientific data for the systematic review of the monograph on Polypodium vulgare L., rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2016-07-15 - 2016-10-15","first_published_date":"2016-07-15T13:00:00Z","last_updated_date":"2016-07-15T13:00:00Z","reference_number":"EMA/HMPC/403790/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-systematic-review-monograph-polypodium-vulgare-l-rhizoma_en.pdf"},
    {"id":"42000","name":"Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-10-31 - 2018-04-30","first_published_date":"2017-10-31T13:00:00Z","last_updated_date":"2017-10-31T13:00:00Z","reference_number":"EMA/HMPC/541422/2017 Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-new-analytical-methods-technologies-quality-control-herbal-medicinal-products_en.pdf"},
    {"id":"42004","name":"Concept paper on revision of the guideline on clinical development of vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2017-06-23 - 2017-09-30","first_published_date":"2017-06-23T20:13:00Z","last_updated_date":"2017-06-23T20:13:00Z","reference_number":"EMA/CHMP/VWP/124350/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-clinical-development-vaccines_en.pdf"},
    {"id":"42091","name":"Draft reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-09-21 - 2018-12-21","first_published_date":"2018-09-21T20:00:00Z","last_updated_date":"2018-09-21T20:00:00Z","reference_number":"EMA/CVMP/AWP/842786/2015","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-aminopenicillins-and-their-beta-lactamase-inhibitor-combinations-animals-european-union-development-resistance-and-impact-human-and-animal-health-first-version_en.pdf"},
    {"id":"42110","name":"Draft Reflection paper on resistance in ectoparasites","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-02-21 - 2019-08-31","first_published_date":"2018-09-21T20:00:00Z","last_updated_date":"2018-09-21T20:00:00Z","reference_number":"EMA/CVMP/EWP/310225/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-resistance-ectoparasites_en.pdf"},
    {"id":"42135","name":"Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-09-21 - 2018-11-30","first_published_date":"2018-09-21T17:30:00Z","last_updated_date":"2018-09-21T17:30:00Z","reference_number":"EMA/CHMP/SAWP/527447/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-stride-velocity-95th-centile-secondary-endpoint-duchenne-muscular-dystrophy-measured-valid-and-suitable-wearable-device_en.pdf"},
    {"id":"42141","name":"ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines - Step 2b - Draft guideline","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-09-24 - 2019-03-24","first_published_date":"2018-09-27T13:08:00Z","last_updated_date":"2018-09-27T13:08:00Z","reference_number":"EMA/CHMP/ICH/616110/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-s11-nonclinical-safety-testing-support-development-paediatric-medicines-step-2b-draft-guideline_en.pdf"},
    {"id":"42690","name":"Draft qualification opinion on eSource Direct Data Capture (DDC)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-15 - 2019-03-14","first_published_date":"2018-11-15T13:22:00Z","last_updated_date":"2018-11-15T13:22:00Z","reference_number":"EMA/282576/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-esource-direct-data-capture-ddc_en.pdf"},
    {"id":"42691","name":"Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CHMP/EWP/714/98 rev 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-12 - 2019-06-30","first_published_date":"2018-11-15T15:15:00Z","last_updated_date":"2018-11-15T15:15:00Z","reference_number":"EMA/CHMP/78339/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-revision-note-guidance-clinical-investigation-medicinal-products-treatment-peripheral-arterial-occlusive-disease-chmp-ewp-714-98-rev-1_en.pdf"},
    {"id":"42692","name":"Draft guideline on the quality of water for pharmaceutical use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-15 - 2019-05-15","first_published_date":"2018-11-15T15:44:00Z","last_updated_date":"2018-11-15T15:44:00Z","reference_number":"EMA/CHMP/CVMP/QWP/496873/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-water-pharmaceutical-use_en.pdf"},
    {"id":"42716","name":"Draft information for the package leaflet regarding dextrans used as excipients in medicinal products for human use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-19 - 2019-05-31","first_published_date":"2018-11-19T13:01:00Z","last_updated_date":"2018-11-19T13:01:00Z","reference_number":"EMA/CHMP/187129/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"42717","name":"Draft information for the package leaflet regarding lactose used as an excipient in medicinal products for human use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-19 - 2019-05-31","first_published_date":"2018-11-19T13:04:00Z","last_updated_date":"2018-11-19T13:04:00Z","reference_number":"EMA/CHMP/186428/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-lactose-used-excipient-medicinal-products-human-use_en.pdf"},
    {"id":"42718","name":"Draft information for the package leaflet regarding polysorbates used as excipients in medicinal products for human use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-19 - 2019-05-31","first_published_date":"2018-11-19T13:06:00Z","last_updated_date":"2018-11-19T13:06:00Z","reference_number":"EMA/CHMP/190743/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-information-package-leaflet-regarding-polysorbates-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"42731","name":"Draft reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-21 - 2019-08-31","first_published_date":"2018-11-21T16:35:00Z","last_updated_date":"2018-11-21T16:35:00Z","reference_number":"EMA/CVMP/ERA/632109/2014","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-antimicrobial-resistance-environment-considerations-current-and-future-risk-assessment-veterinary-medicinal-products-first-version_en.pdf"},
    {"id":"42742","name":"Draft guideline on the non-clinical requirements for radiopharmaceuticals - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-22 - 2019-06-30","first_published_date":"2018-11-22T13:15:00Z","last_updated_date":"2018-11-22T13:15:00Z","reference_number":"EMA/CHMP/SWP/686140/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-requirements-radiopharmaceuticals-first-version_en.pdf"},
    {"id":"42766","name":"Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-11-23 - 2019-06-30","first_published_date":"2018-11-23T18:45:00Z","last_updated_date":"2018-11-23T18:45:00Z","reference_number":"EMA/CHMP/763438/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/paediatric-addendum-guidelines-clinical-investigation-medicinal-products-treatment-and-prophylaxis-venous-thromboembolic-disease_en.pdf"},
    {"id":"42889","name":"Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-03 - 2019-06-30","first_published_date":"2018-11-30T12:12:00Z","last_updated_date":"2018-12-19T16:55:00Z","reference_number":"EMA/CHMP/BPWP/144552/2009 rev. 2 Corr.1 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-recombinant-and-human-plasma-derived-factor-ix-products-revision-2_en.pdf"},
    {"id":"42890","name":"Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-03 - 2019-06-30","first_published_date":"2018-11-30T13:00:00Z","last_updated_date":"2018-11-30T13:00:00Z","reference_number":"EMA/CHMP/BPWP/1625/1999 rev. 3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-plasma-derived-and-recombinant-coagulation-factor-ix-products-revision-3_en.pdf"},
    {"id":"42891","name":"Draft guideline on the environmental risk assessment of medicinal products for human use - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-01 - 2019-06-30","first_published_date":"2018-11-30T13:23:00Z","last_updated_date":"2018-11-30T13:23:00Z","reference_number":"EMEA/CHMP/SWP/4447/00 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-environmental-risk-assessment-medicinal-products-human-use-revision-1_en.pdf"},
    {"id":"43065","name":"Draft guideline on quality and equivalence of topical products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-14 - 2019-06-30","first_published_date":"2018-12-14T12:30:00Z","last_updated_date":"2018-12-14T12:30:00Z","reference_number":"CHMP/QWP/708282/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-and-equivalence-topical-products_en.pdf"},
    {"id":"43097","name":"Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-17 - 2019-08-31","first_published_date":"2018-12-17T11:06:00Z","last_updated_date":"2018-12-17T11:06:00Z","reference_number":"EMA/CVMP/QWP/153641/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-risk-management-requirements-elemental-impurities-veterinary-medicinal-products_en.pdf"},
    {"id":"43098","name":"Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-21 - 2019-06-30","first_published_date":"2018-12-17T11:57:00Z","last_updated_date":"2018-12-17T11:57:00Z","reference_number":"EMA/CHMP/802491/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ezetimibe-tablet-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"43099","name":"Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-21 - 2019-06-30","first_published_date":"2018-12-17T13:29:00Z","last_updated_date":"2018-12-17T13:29:00Z","reference_number":"EMA/CHMP/790333/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-cabozantinib-tablet-20-mg-40-mg-and-60-mg-capsule-20-4-mg-and-80-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"43125","name":"Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-18 - 2019-08-31","first_published_date":"2018-12-18T16:10:00Z","last_updated_date":"2018-12-18T16:10:00Z","reference_number":"EMA/CVMP/SWP/66781/2005 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-and-residue-data-requirements-pharmaceutical-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market-revision-2_en.pdf"},
    {"id":"43152","name":"Draft guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-19 - 2019-08-31","first_published_date":"2018-12-19T11:00:00Z","last_updated_date":"2018-12-19T11:00:00Z","reference_number":"EMA/CVMP/IWP/170689/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-quality-production-and-control-safety-and-efficacy-allergen-products-use-horses-dogs-and-cats-revision-1_en.pdf"},
    {"id":"43153","name":"Draft EMA Regulatory Science to 2025 - Strategic reflection","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-19 - 2019-06-30","first_published_date":"2018-12-19T13:00:00Z","last_updated_date":"2018-12-19T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-ema-regulatory-science-2025-strategic-reflection_en.pdf"},
    {"id":"43196","name":"Concept paper on a guideline for allergen products development in moderate to low-sized study populations","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2018-12-21 - 2019-06-30","first_published_date":"2018-12-20T13:54:00Z","last_updated_date":"2018-12-20T13:54:00Z","reference_number":"EMA/CHMP/251023/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-allergen-products-development-moderate-low-sized-study-populations_en.pdf"},
    {"id":"43350","name":"Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-01-14 - 2019-07-31","first_published_date":"2019-01-14T12:32:00Z","last_updated_date":"2019-01-14T12:32:00Z","reference_number":"EMA/844951/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-revision-3_en.pdf"},
    {"id":"43351","name":"Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-01-14 - 2019-04-14","first_published_date":"2019-01-14T16:10:00Z","last_updated_date":"2019-01-14T16:10:00Z","reference_number":"EMA/CHMP/755489/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-evaluation-anticancer-medicinal-products-man_en.pdf"},
    {"id":"43352","name":"Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2019-01-15 - 2019-03-31","first_published_date":"2019-01-14T16:57:00Z","last_updated_date":"2019-01-14T16:57:00Z","reference_number":"EMA/CVMP/CHMP/682199/2017","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/answer-request-european-commission-updating-scientific-advice-impact-public-health-and-animal-health-use-antibiotics-animals-preliminary-risk-profiling-new-antimicrobials_en.pdf"},
    {"id":"43555","name":"Draft procedure on management of proposals submitted by Interested Parties for European Union List Entries or European Union herbal monographs - Revision 2","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2019-01-30 - 2019-07-30","first_published_date":"2019-01-30T18:00:00Z","last_updated_date":"2019-01-30T18:00:00Z","reference_number":"EMEA/HMPC/328575/2007 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-procedure-management-proposals-submitted-interested-parties-european-union-list-entries-or-european-union-herbal-monographs-revision-2_en.pdf"},
    {"id":"43559","name":"Electronic product information for human medicines in the European Union – draft key principles","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2019-01-31 - 2019-07-31","first_published_date":"2019-01-31T13:00:00Z","last_updated_date":"2019-01-31T13:00:00Z","reference_number":"EMA/849614/2018","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-draft-key-principles_en.pdf"},
    {"id":"43629","name":"Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Categorisation of antimicrobials","type":"other","status":"Draft: consultation closed","consultation_date":"2019-02-05 - 2019-04-30","first_published_date":"2019-02-05T15:03:00Z","last_updated_date":"2019-02-05T15:03:00Z","reference_number":"EMA/CVMP/CHMP/682198/2017","document_url":"https://www.ema.europa.eu/en/documents/other/answer-request-european-commission-updating-scientific-advice-impact-public-health-and-animal-health-use-antibiotics-animals-categorisation-antimicrobials_en.pdf"},
    {"id":"43669","name":"Draft guideline on clinical investigation of medicinal products for the treatment of gout - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-02-08 - 2019-08-31","first_published_date":"2019-02-08T09:45:00Z","last_updated_date":"2019-08-07T15:50:00Z","reference_number":"EMA/CHMP/774470/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-gout-first-version_en.pdf"},
    {"id":"43671","name":"Draft alectinib hard capsule 150 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-02-08 - 2019-06-30","first_published_date":"2019-02-08T09:40:00Z","last_updated_date":"2019-02-08T09:40:00Z","reference_number":"EMA/CHMP/790261/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-alectinib-hard-capsule-150-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"43672","name":"Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-02-08 - 2019-06-30","first_published_date":"2019-02-08T10:00:00Z","last_updated_date":"2019-02-08T10:00:00Z","reference_number":"EMA/CHMP/802679/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-palbociclib-hard-capsule-75-mg-100-mg-and-125-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"43721","name":"Draft European Union herbal monograph on Rhamnus frangula L., cortex - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T10:00:00Z","last_updated_date":"2019-02-15T10:00:00Z","reference_number":"EMA/HMPC/726261/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-rhamnus-frangula-l-cortex-revision-1_en.pdf"},
    {"id":"43739","name":"Call for scientific data for the periodic review of the monograph on Arctium lappa L., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:33:00Z","last_updated_date":"2019-02-15T09:33:00Z","reference_number":"EMA/HMPC/38300/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-arctium-lappa-l-radix_en.pdf"},
    {"id":"43740","name":"Call for scientific data for the periodic review of the monograph on Juniperus communis L., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:35:00Z","last_updated_date":"2019-02-15T09:35:00Z","reference_number":"EMA/HMPC/38797/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-juniperus-communis-l-aetheroleum_en.pdf"},
    {"id":"43741","name":"Call for scientific data for the periodic review of the monograph on Juniperus communis L., pseudo-fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:40:00Z","last_updated_date":"2019-02-15T09:40:00Z","reference_number":"EMA/HMPC/38812/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-juniperus-communis-l-pseudo-fructus_en.pdf"},
    {"id":"43742","name":"Call for scientific data for the periodic review of the monograph on Orthosiphon stamineus Benth., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:42:00Z","last_updated_date":"2019-02-15T09:42:00Z","reference_number":"EMA/HMPC/38821/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-orthosiphon-stamineus-benth-folium_en.pdf"},
    {"id":"43743","name":"Call for scientific data for the periodic review of the monograph on Rosmarinus officinalis L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:44:00Z","last_updated_date":"2019-02-15T09:44:00Z","reference_number":"EMA/HMPC/38836/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-rosmarinus-officinalis-l-folium_en.pdf"},
    {"id":"43744","name":"Call for scientific data for the periodic review of the monograph on Rosmarinus officinalis L., aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:46:00Z","last_updated_date":"2019-02-15T09:46:00Z","reference_number":"EMA/HMPC/38833/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-rosmarinus-officinalis-l-aetheroleum_en.pdf"},
    {"id":"43745","name":"Call for scientific data for the periodic review of the monograph on Taraxacum officinale Weber ex Wigg., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:48:00Z","last_updated_date":"2019-02-15T09:48:00Z","reference_number":"EMA/HMPC/38842/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-taraxacum-officinale-weber-ex-wigg-folium_en.pdf"},
    {"id":"43746","name":"Call for scientific data for the periodic review of the monograph on Taraxacum officinale Weber ex Wigg., radix cum herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-15 - 2019-05-15","first_published_date":"2019-02-15T09:50:00Z","last_updated_date":"2019-02-15T09:50:00Z","reference_number":"EMA/HMPC/38849/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-taraxacum-officinale-weber-ex-wigg-radix-cum-herba_en.pdf"},
    {"id":"43929","name":"Call for scientific data for use in HMPC assessment work on ‘Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) - First version’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-28 - 2019-08-31","first_published_date":"2019-02-28T11:26:00Z","last_updated_date":"2019-02-28T11:26:00Z","reference_number":"EMA/HMPC/39600/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas-first-version_en.pdf"},
    {"id":"43930","name":"Call for scientific data for use in HMPC assessment work on ‘Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids (EMA/HMPC/328782/2016)’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2019-02-28 - 2019-08-31","first_published_date":"2019-02-28T11:33:00Z","last_updated_date":"2019-02-28T11:33:00Z","reference_number":"EMA/HMPC/37920/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-public-statement-contamination-herbal-medicinal-products-traditional-herbal-medicinal-products-pyrrolizidine-alkaloids-ema-hmpc-328782-2016_en.pdf"},
    {"id":"43998","name":"Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-03-08 - 2019-06-30","first_published_date":"2019-03-08T15:39:00Z","last_updated_date":"2019-03-08T15:39:00Z","reference_number":"EMA/CHMP/35552/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-colchicine-tablet-05-mg-and-1-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"44025","name":"Draft ICH guideline M10 on bioanalytical method validation - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-03-14 - 2019-09-01","first_published_date":"2019-03-14T09:06:00Z","last_updated_date":"2019-03-14T09:06:00Z","reference_number":"EMA/CHMP/ICH/172948/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m10-bioanalytical-method-validation-step-2b_en.pdf"},
    {"id":"44116","name":"Draft ICH guideline E19 on optimisation of safety data collection - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-03-29 - 2019-09-29","first_published_date":"2019-03-29T15:00:00Z","last_updated_date":"2019-03-29T15:00:00Z","reference_number":"EMA/CHMP/ICH/173706/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-e19-optimisation-safety-data-collection-step-2b_en.pdf"},
    {"id":"44480","name":"Draft ICH guideline E8 (R1) on general considerations for clinical studies - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-05-10 - 2019-09-30","first_published_date":"2019-05-10T17:25:00Z","last_updated_date":"2019-05-10T17:25:00Z","reference_number":"EMA/CHMP/ICH/544570/1998","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-e8-r1-general-considerations-clinical-studies-step-2b_en.pdf"},
    {"id":"44598","name":"Draft etonogestrel and ethinylestradiol vaginal delivery system 0.12mg/0.015mg/day product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-05-27 - 2019-10-28","first_published_date":"2019-05-27T19:19:00Z","last_updated_date":"2019-05-27T19:19:00Z","reference_number":"EMA/CHMP/97470/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-etonogestrel-and-ethinylestradiol-vaginal-delivery-system-012mg-0015mg-day-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"44637","name":"Draft guideline on the quality requirements for drug-device combinations - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-06-03 - 2019-08-31","first_published_date":"2019-06-03T16:00:00Z","last_updated_date":"2019-06-03T16:00:00Z","reference_number":"EMA/CHMP/QWP/BWP/259165/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf"},
    {"id":"44726","name":"Draft European Union list entry on Mentha x piperita L., aetheroleum - Revision 1","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2019-06-15 - 2019-09-15","first_published_date":"2019-06-18T10:43:00Z","last_updated_date":"2019-06-18T10:43:00Z","reference_number":"EMA/HMPC/679997/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-european-union-list-entry-mentha-x-piperita-l-aetheroleum-revision-1_en.pdf"},
    {"id":"44728","name":"Draft European Union herbal monograph on Mentha x piperita L., aetheroleum - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-06-15 - 2019-09-15","first_published_date":"2019-06-18T10:47:00Z","last_updated_date":"2019-06-18T10:47:00Z","reference_number":"EMA/HMPC/522410/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-mentha-x-piperita-l-aetheroleum-revision-1_en.pdf"},
    {"id":"44736","name":"Draft list of references supporting the assessment of Aesculus hippocastanum L., semen - Revision 1","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2019-06-15 - 2019-09-15","first_published_date":"2019-06-18T16:01:00Z","last_updated_date":"2019-06-18T16:01:00Z","reference_number":"EMA/HMPC/638245/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-aesculus-hippocastanum-l-semen-revision-1_en.pdf"},
    {"id":"44737","name":"Draft European Union herbal monograph on Aesculus hippocastanum L., semen - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-06-15 - 2019-09-15","first_published_date":"2019-06-18T16:03:00Z","last_updated_date":"2019-06-18T16:03:00Z","reference_number":"EMA/HMPC/628242/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-aesculus-hippocastanum-l-semen-revision-1_en.pdf"},
    {"id":"44744","name":"Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses","type":"other","status":"Draft: consultation closed","consultation_date":"2019-06-19 - 2019-10-09","first_published_date":"2019-06-19T12:26:00Z","last_updated_date":"2019-06-19T12:26:00Z","reference_number":"EMA/CHMP/SAWP/291384/2019","document_url":"https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-clinically-interpretable-treatment-effect-measures-based-recurrent-event-endpoints-allow-efficient-statistical-analyses_en.pdf"},
    {"id":"44752","name":"Draft qualification opinion of Multiple sclerosis clinical outcome assessment (MSCOA)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-06-18 - 2019-09-20","first_published_date":"2019-06-19T12:37:00Z","last_updated_date":"2019-07-02T10:55:00Z","reference_number":"EMA/CHMP/SAWP/336445/2019 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-qualification-opinion-multiple-sclerosis-clinical-outcome-assessment-mscoa_en.pdf"},
    {"id":"45692","name":"Draft European Union herbal monograph on Rhamnus purshiana DC., cortex - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-10-15 - 2020-01-15","first_published_date":"2019-10-15T11:03:00Z","last_updated_date":"2019-10-15T11:03:00Z","reference_number":"EMA/HMPC/726270/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-rhamnus-purshiana-dc-cortex-revision-1_en.pdf"},
    {"id":"45693","name":"Draft European Union herbal monograph on Rheum palmatum L. and Rheum officinale Baillon, radix - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-10-15 - 2020-01-15","first_published_date":"2019-10-15T11:03:00Z","last_updated_date":"2019-10-15T11:03:00Z","reference_number":"EMA/HMPC/113700/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-rheum-palmatum-l-and-rheum-officinale-baillon-radix-revision-1_en.pdf"},
    {"id":"45694","name":"Draft European Union herbal monograph on Tanacetum parthenium (L.) Schultz Bip., herba - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-10-15 - 2020-01-15","first_published_date":"2019-10-15T11:03:00Z","last_updated_date":"2019-10-15T11:03:00Z","reference_number":"EMA/HMPC/48715/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-tanacetum-parthenium-l-schultz-bip-herba-revision-1_en.pdf"},
    {"id":"45695","name":"Draft European Union herbal monograph on Thymus vulgaris L., Thymus zygis L., aetheroleum - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-10-15 - 2020-01-15","first_published_date":"2019-10-15T11:03:00Z","last_updated_date":"2019-10-15T11:03:00Z","reference_number":"EMA/HMPC/59032/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-thymus-vulgaris-l-thymus-zygis-l-aetheroleum-revision-1_en.pdf"},
    {"id":"45762","name":"Reflection paper on promoting the authorisation of alternatives to antimicrobials in the EU","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-10-18 - 2020-04-30","first_published_date":"2019-10-18T17:10:00Z","last_updated_date":"2019-10-18T17:10:00Z","reference_number":"EMA/CVMP/461776/2017","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-promoting-authorisation-alternatives-antimicrobials-eu_en.pdf"},
    {"id":"46050","name":"Draft VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-11-18 - 2020-04-10","first_published_date":"2019-11-18T16:34:00Z","last_updated_date":"2019-11-18T16:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl59-harmonisation-criteria-waive-laboratory-animal-batch-safety-testing-vaccines-veterinary-use_en.pdf"},
    {"id":"46091","name":"Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2019-11-21 - 2020-01-31","first_published_date":"2019-11-21T18:00:00Z","last_updated_date":"2019-11-21T18:00:00Z","reference_number":"EMA/CVMP/539861/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-scientific-guidelines-limited-market-veterinary-medicinal-products_en.pdf"},
    {"id":"46280","name":"Open call for data on use of antimicrobials in animals","type":"other","status":"Draft: consultation closed","consultation_date":"2019-12-10 - 2020-03-06","first_published_date":"2019-12-10T15:17:00Z","last_updated_date":"2019-12-10T15:17:00Z","reference_number":"EMA/536558/2019","document_url":"https://www.ema.europa.eu/en/documents/other/open-call-data-use-antimicrobials-animals_en.pdf"},
    {"id":"46339","name":"Draft European Union herbal monograph on Herniaria glabra L., H. hirsuta L., H. incana Lam., herba","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2019-12-19 - 2020-03-15","first_published_date":"2019-12-19T12:39:00Z","last_updated_date":"2019-12-19T12:39:00Z","reference_number":"EMA/HMPC/554043/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-herniaria-glabra-l-h-hirsuta-l-h-incana-lam-herba_en.pdf"},
    {"id":"46461","name":"Draft reflection paper on good manufacturing practice and marketing authorisation holders","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-01-17 - 2020-07-17","first_published_date":"2020-01-20T14:34:00Z","last_updated_date":"2020-04-29T18:40:00Z","reference_number":"EMA/457570/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-good-manufacturing-practice-and-marketing-authorisation-holders_en.pdf"},
    {"id":"46650","name":"Draft European Union herbal monograph on Achillea millefolium L., herba - Revision 1","type":"herbal-opinion","status":"Draft: consultation closed","consultation_date":"2020-01-30 - 2020-04-30","first_published_date":"2020-01-31T17:16:00Z","last_updated_date":"2020-01-31T17:16:00Z","reference_number":"EMA/HMPC/376416/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/draft-european-union-herbal-monograph-achillea-millefolium-l-herba-revision-1_en.pdf"},
    {"id":"46651","name":"Draft European Union list entry on Achillea millefolium L., herba - Revision 1","type":"herbal-list-entry","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T17:31:00Z","last_updated_date":"2020-01-31T17:31:00Z","reference_number":"EMA/HMPC/376417/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-list-entry/draft-european-union-list-entry-achillea-millefolium-l-herba-revision-1_en.pdf"},
    {"id":"46654","name":"Call for scientific data for the revision of the monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T17:59:00Z","last_updated_date":"2020-01-31T17:59:00Z","reference_number":"EMA/HMPC/47573/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-revision-monograph-pelargonium-sidoides-dc-pelargonium-reniforme-curt-radix-revision-1_en.pdf"},
    {"id":"46655","name":"Call for scientific data for the periodic review of the monograph on Cola nitida (Vent.) Schott et Endl. (C. vera K. Schum.); Cola acuminata (P. Beauv.) Schott et Endl. (Sterculia acuminata P. Beauv.), semen - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T18:08:00Z","last_updated_date":"2020-01-31T18:08:00Z","reference_number":"EMA/HMPC/50864/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-cola-nitida-vent-schott-et-endl-c-vera-k-schum-cola-acuminata-p-beauv-schott-et-endl-sterculia-acuminata-p-beauv-semen-revision-1_en.pdf"},
    {"id":"46656","name":"Call for scientific data for the periodic review of the monograph on Chamaemelum nobile (L.) All. (Anthemis nobilis L.), flos - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T18:21:00Z","last_updated_date":"2020-01-31T18:21:00Z","reference_number":"EMA/HMPC/50752/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-chamaemelum-nobile-l-all-anthemis-nobilis-l-flos-revision-1_en.pdf"},
    {"id":"46657","name":"Call for scientific data for the periodic review of the monograph on Zingiber officinale Roscoe, rhizoma - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T18:28:00Z","last_updated_date":"2020-01-31T18:28:00Z","reference_number":"EMA/HMPC/47493/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-zingiber-officinale-roscoe-rhizoma-revision-1_en.pdf"},
    {"id":"46658","name":"Call for scientific data for the periodic review of the monograph on Carum carvi L., fructus - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T18:53:00Z","last_updated_date":"2020-01-31T18:53:00Z","reference_number":"EMA/HMPC/47469/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-carum-carvi-l-fructus-revision-1_en.pdf"},
    {"id":"46659","name":"Call for scientific data for the periodic review of the monograph on Carum carvi L., aetheroleum - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T18:59:00Z","last_updated_date":"2020-01-31T18:59:00Z","reference_number":"EMA/HMPC/47463/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-carum-carvi-l-aetheroleum-revision-1_en.pdf"},
    {"id":"46660","name":"Call for scientific data for the periodic review of the monograph on Syzygium aromaticum (L.) Merill et L. M. Perry (Eugenia caryophyllus (C. Spreng.) Bull. et Harr.), aetheroleum - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T19:07:00Z","last_updated_date":"2020-01-31T19:07:00Z","reference_number":"EMA/HMPC/47048/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-syzygium-aromaticum-l-merill-et-l-m-perry-eugenia-caryophyllus-c-spreng-bull-et-harr-aetheroleum-revision-1_en.pdf"},
    {"id":"46661","name":"Call for scientific data for the periodic review of the monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-02-01 - 2020-04-30","first_published_date":"2020-01-31T19:12:00Z","last_updated_date":"2020-01-31T19:12:00Z","reference_number":"EMA/HMPC/47033/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-agropyron-repens-l-p-beauv-rhizoma-revision-1_en.pdf"},
    {"id":"46742","name":"Public statement on the use of herbal medicinal products containing estragole - Revision 1","type":"other","status":"Draft: consultation closed","consultation_date":"2020-02-15 - 2020-05-15","first_published_date":"2020-02-14T13:20:00Z","last_updated_date":"2023-06-09T15:43:00Z","reference_number":"EMA/HMPC/137212/2005 Rev. 1 Corr.","document_url":"https://www.ema.europa.eu/en/documents/other/public-statement-use-herbal-medicinal-products-containing-estragole-revision-1_en.pdf"},
    {"id":"46915","name":"Call for scientific data for the periodic review of the monograph on Cinnamomum verum J.S. Presl, cortex","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/103543/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-cinnamomum-verum-js-presl-cortex_en.pdf"},
    {"id":"46916","name":"Call for scientific data for the periodic review of the monograph on Cinnamomum verum J.S. Presl, corticis aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/103542/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-cinnamomum-verum-js-presl-corticis-aetheroleum_en.pdf"},
    {"id":"46917","name":"Call for scientific data for the periodic review of the monograph on Fucus vesiculosus L., thallus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/103567/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-fucus-vesiculosus-l-thallus_en.pdf"},
    {"id":"46918","name":"Call for scientific data for the periodic review of the monograph on Fumaria officinalis L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/103631/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-fumaria-officinalis-l-herba_en.pdf"},
    {"id":"46919","name":"Call for scientific data for the periodic review of the monograph on Lavandula angustifolia Miller, aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/103634/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-lavandula-angustifolia-miller-aetheroleum_en.pdf"},
    {"id":"46920","name":"Call for scientific data for the periodic review of the monograph on Lavandula angustifolia Miller, flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/103640/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-lavandula-angustifolia-miller-flos_en.pdf"},
    {"id":"46921","name":"Call for scientific data for use in HMPC assessment work on Taraxacum officinale F.H. Wigg., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-03-01 - 2020-05-31","first_published_date":"2020-03-02T11:15:00Z","last_updated_date":"2020-03-02T11:15:00Z","reference_number":"EMA/HMPC/47428/2020 ","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-taraxacum-officinale-fh-wigg-radix_en.pdf"},
    {"id":"47113","name":"Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-03-25 - 2020-04-25","first_published_date":"2020-03-25T16:45:00Z","last_updated_date":"2020-03-25T16:45:00Z","reference_number":"EMA/158330/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/points-consider-implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical-trials_en.pdf"},
    {"id":"47238","name":"Call for scientific data for the periodic review of the monograph on Ilex paraguariensis St. Hilaire, folium - Second round","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-04-01 - 2020-06-30","first_published_date":"2020-04-01T11:00:00Z","last_updated_date":"2020-04-01T11:00:00Z","reference_number":"EMA/HMPC/149070/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-ilex-paraguariensis-st-hilaire-folium-second-round_en.pdf"},
    {"id":"47239","name":"Call for scientific data for the periodic review of the monograph on Plantago lanceolata L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-04-01 - 2020-06-30","first_published_date":"2020-04-01T11:00:00Z","last_updated_date":"2020-04-01T11:00:00Z","reference_number":"EMA/HMPC/149054/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-plantago-lanceolata-l-folium_en.pdf"},
    {"id":"47240","name":"Call for scientific data for the periodic review of the monograph on Solanum dulcamara L., stipites","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-04-01 - 2020-06-30","first_published_date":"2020-04-01T11:00:00Z","last_updated_date":"2020-04-01T11:00:00Z","reference_number":"EMA/HMPC/149095/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-solanum-dulcamara-l-stipites_en.pdf"},
    {"id":"47241","name":"Call for scientific data for the periodic review of the monograph on Urtica dioica L.; Urtica urens L., folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-04-01 - 2020-06-30","first_published_date":"2020-04-01T11:00:00Z","last_updated_date":"2020-04-01T11:00:00Z","reference_number":"EMA/HMPC/149137/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-urtica-dioica-l-urtica-urens-l-folium_en.pdf"},
    {"id":"47242","name":"Call for scientific data for the periodic review of the monograph on Urtica dioica L. and Urtica urens L., herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-04-01 - 2020-06-30","first_published_date":"2020-04-01T11:00:00Z","last_updated_date":"2020-04-01T11:00:00Z","reference_number":"EMA/HMPC/149163/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-urtica-dioica-l-and-urtica-urens-l-herba_en.pdf"},
    {"id":"47243","name":"Call for scientific data for the periodic review of the monograph on Viola tricolor L. and/or subspecies Viola arvensis Murray (Gaud) and Viola vulgaris Koch (Oborny), herba cum flore","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-04-01 - 2020-06-30","first_published_date":"2020-04-01T11:00:00Z","last_updated_date":"2020-04-01T11:00:00Z","reference_number":"EMA/HMPC/149175/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-viola-tricolor-l-and-or-subspecies-viola-arvensis-murray-gaud-and-viola-vulgaris-koch-oborny-herba-cum-flore_en.pdf"},
    {"id":"47557","name":"Q3C (R8) Step 2b - impurities guideline for residual solvents - Pde for 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-05-04 - 2020-07-30","first_published_date":"2020-05-04T17:13:00Z","last_updated_date":"2020-05-04T17:13:00Z","reference_number":"EMA/CHMP/ICH/213867/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/q3c-r8-step-2b-impurities-guideline-residual-solvents-pde-2-methyltetrahydrofuran-cyclopentyl-methyl-ether-and-tertiary-butyl-alcohol_en.pdf"},
    {"id":"47571","name":"Draft dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-05-04 - 2020-08-31","first_published_date":"2020-05-06T11:10:00Z","last_updated_date":"2020-05-06T11:10:00Z","reference_number":"EMA/CHMP/675838/2014/Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dasatinib-film-coated-tablets-20-50-70-80-100-140-mg-and-suspension-10-mg-ml-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"47584","name":"Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-05-07 - 2020-10-31","first_published_date":"2020-05-07T12:08:00Z","last_updated_date":"2020-05-07T12:08:00Z","reference_number":"EMA/CVMP/ERA/55512/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-environmental-risk-assessment-parasiticide-veterinary-medicinal-products-used-companion-animals_en.pdf"},
    {"id":"47790","name":"Draft European Union herbal monograph on Species sedativae","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2020-05-31 - 2020-08-31","first_published_date":"2020-05-29T13:22:00Z","last_updated_date":"2020-05-29T13:22:00Z","reference_number":"EMA/HMPC/438183/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-species-sedativae_en.pdf"},
    {"id":"47797","name":"Draft European Union herbal monograph on Species amarae","type":"herbal-monograph","status":"Draft","consultation_date":"2020-05-31 - 2020-08-31","first_published_date":"2020-05-28T16:45:00Z","last_updated_date":"2020-05-28T16:45:00Z","reference_number":"EMA/HMPC/44543/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-species-amarae_en.pdf"},
    {"id":"47820","name":"Draft European Union herbal monograph on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2020-05-31 - 2020-08-31","first_published_date":"2020-05-29T13:28:00Z","last_updated_date":"2020-05-29T13:28:00Z","reference_number":"EMA/HMPC/376770/2019","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-aloysia-citrodora-palau-syn-aloysia-triphylla-lher-kuntze-verbena-triphylla-lher-lippia-citriodora-kunth-folium_en.pdf"},
    {"id":"48007","name":"Draft Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-06-15 - 2020-09-30","first_published_date":"2020-06-15T13:30:00Z","last_updated_date":"2020-06-15T13:30:00Z","reference_number":"EMA/CHMP/176098/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-levothyroxine-tablets-125-mcg-25-mcg-50-mcg-75-mcg-100-mcg-and-additional-strengths-and-200-mcg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"48009","name":"Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-06-15 - 2020-09-30","first_published_date":"2020-06-15T16:41:00Z","last_updated_date":"2020-06-15T16:41:00Z","reference_number":"EMA/CHMP/474712/2016 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-abiraterone-tablets-250-mg-and-500-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"48193","name":"Draft CVMP strategy on antimicrobials 2021-2025","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-07-01 - 2020-09-30","first_published_date":"2020-07-01T12:25:00Z","last_updated_date":"2020-07-01T12:25:00Z","reference_number":"EMA/CVMP/179874/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-cvmp-strategy-antimicrobials-2021-2025_en.pdf"},
    {"id":"48221","name":"Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance - First version (2nd draft)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-07-06 - 2021-01-31","first_published_date":"2020-07-03T16:58:00Z","last_updated_date":"2020-11-17T10:30:00Z","reference_number":"EMA/CHMP/257298/2018","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lapatinib-film-coated-tablet-250-mg-product-specific-bioequivalence-guidance-first-version-2nd-draft_en.pdf"},
    {"id":"48225","name":"Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-07-03 - 2020-10-02","first_published_date":"2020-07-03T18:11:00Z","last_updated_date":"2020-07-03T18:11:00Z","reference_number":"EMA/CHMP/ICH/321999/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-and-answers-ich-guideline-m7-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-step-2b_en.pdf"},
    {"id":"48325","name":"Draft Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2020-07-17 - 2020-09-18","first_published_date":"2020-07-17T19:10:00Z","last_updated_date":"2020-07-17T19:10:00Z","reference_number":"EMA/198149/2020 ","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-union-product-database-upd-access-policy-veterinary-medicinal-products-policy-no-0082_en.pdf"},
    {"id":"48333","name":"Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2020-07-20 - 2020-09-21","first_published_date":"2020-07-20T17:33:00Z","last_updated_date":"2020-07-20T17:33:00Z","reference_number":"EMA/CVMP/340959/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-development-reflection-paper-criteria-application-article-405-regulation-eu-2019-6_en.pdf"},
    {"id":"48513","name":"Call for scientific data for the periodic review of the monograph on Serenoa repens (Bartram) Small (Sabal serrulata (Michaux) Nichols)","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2020-08-01 - 2020-10-31","first_published_date":"2020-07-31T12:32:00Z","last_updated_date":"2020-07-31T12:32:00Z","reference_number":"EMA/HMPC/283960/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-serenoa-repens-bartram-small-sabal-serrulata-michaux-nichols_en.pdf"},
    {"id":"48611","name":"Draft public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with pyrrolizidine alkaloids - Revision 1","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2020-08-15 - 2020-11-15","first_published_date":"2020-08-14T12:40:00Z","last_updated_date":"2020-08-14T12:40:00Z","reference_number":"EMA/HMPC/893108/2011 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas-including-recommendations-regarding-contamination-herbal-medicinal-products-pyrrolizidine_en.pdf"},
    {"id":"48720","name":"ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-08-28 - 2020-11-28","first_published_date":"2020-08-28T14:58:00Z","last_updated_date":"2020-08-28T14:58:00Z","reference_number":"EMA/CHMP/ICH/415588/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e14-s7b-clinical-and-nonclinical-evaluation-qt-qtc-interval-prolongation-and-proarrhythmic-potential-questions-and-answers-step-2b_en.pdf"},
    {"id":"48864","name":"Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-09-18 - 2020-12-25","first_published_date":"2020-09-18T16:39:00Z","last_updated_date":"2020-10-01T13:12:00Z","reference_number":"EMA/CHMP/ICH/353369/2013","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q3d-r2-elemental-impurities-step-2b_en.pdf"},
    {"id":"48999","name":"Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 4","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-10-13 - 2021-01-13","first_published_date":"2020-10-13T15:11:00Z","last_updated_date":"2020-10-13T15:11:00Z","reference_number":"EMA/CHMP/BPWP/94033/2007 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-rev-4_en.pdf"},
    {"id":"49000","name":"Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-10-13 - 2021-01-13","first_published_date":"2020-10-13T15:14:00Z","last_updated_date":"2020-10-13T15:14:00Z","reference_number":"EMA/CHMP/BPWP/94038/2007 Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-human-normal-immunoglobulin-intravenous-administration-ivig-rev-6_en.pdf"},
    {"id":"49196","name":"Draft acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-11-09 - 2021-02-28","first_published_date":"2020-11-09T10:35:00Z","last_updated_date":"2020-11-09T10:35:00Z","reference_number":"EMA/CHMP/512475/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-acenocoumarol-tablet-1-mg-and-4-mg-product-specific-bioequivalence-guidance-first-version_en.pdf"},
    {"id":"49220","name":"Draft concept paper on the reporting of antimicrobial sales and use in animals at the EU level","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2020-11-12 - 2021-01-31","first_published_date":"2020-11-12T10:00:00Z","last_updated_date":"2020-11-12T10:00:00Z","reference_number":"EMA/222040/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-concept-paper-reporting-antimicrobial-sales-and-use-animals-eu-level_en.pdf"},
    {"id":"49257","name":"Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-11-13 - 2021-02-15","first_published_date":"2020-11-16T09:58:00Z","last_updated_date":"2020-11-16T09:58:00Z","reference_number":"EMA/CHMP/205/95 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-evaluation-anticancer-medicinal-products-man-revision-6_en.pdf"},
    {"id":"49258","name":"Draft appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products - Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8","type":"other","status":"Draft: consultation closed","consultation_date":"2020-11-13 - 2021-02-15","first_published_date":"2020-11-16T09:57:00Z","last_updated_date":"2020-11-16T09:57:00Z","reference_number":"EMA/593364/2020 ","document_url":"https://www.ema.europa.eu/en/documents/other/draft-appendix-3-guideline-clinical-evaluation-anticancer-medicinal-products-summary-product-characteristics-anticancer-medicinal-product-mock-48_en.pdf"},
    {"id":"49317","name":"Draft palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-11-23 - 2021-02-28","first_published_date":"2020-11-23T16:24:00Z","last_updated_date":"2020-11-23T16:24:00Z","reference_number":"EMA/CHMP/802679/2018 Rev. 1 Corr. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-palbociclib-hard-capsule-75-mg-100-mg-and-125-mg-and-film-coated-tablet-75-mg-100-mg-and-125-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"49500","name":"ICH reflection paper on proposed ICH guideline work to advance patient focused drug development","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2020-12-10 - 2021-03-07","first_published_date":"2020-12-10T10:30:00Z","last_updated_date":"2020-12-10T10:30:00Z","reference_number":"EMA/CHMP/ICH/415588/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-reflection-paper-proposed-ich-guideline-work-advance-patient-focused-drug-development_en.pdf"},
    {"id":"49788","name":"Draft EudraVigilance access policy for medicines for veterinary use - Revision 2","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-12 - 2021-03-12","first_published_date":"2021-01-12T18:48:00Z","last_updated_date":"2021-01-12T18:48:00Z","reference_number":"EMA/113700/2008 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-eudravigilance-access-policy-medicines-veterinary-use-revision-2_en.pdf"},
    {"id":"49795","name":"Draft guidance - Parallel application for EU-M4all (Article 58) opinion and centralised marketing authorisation procedure","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-14 - 2021-02-15","first_published_date":"2021-01-14T10:50:00Z","last_updated_date":"2021-01-14T10:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guidance-parallel-application-eu-m4all-article-58-opinion-and-centralised-marketing-authorisation-procedure_en.pdf"},
    {"id":"49977","name":"Draft concept paper for the development of a guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-29 - 2021-03-31","first_published_date":"2021-01-29T15:00:00Z","last_updated_date":"2021-01-29T15:00:00Z","reference_number":"EMA/CVMP/IWP/630533/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-guideline-data-requirements-authorisation-immunological-veterinary-medicinal-products-under-exceptional-circumstances_en.pdf"},
    {"id":"49978","name":"Draft concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD) - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-29 - 2021-03-31","first_published_date":"2021-01-29T15:04:00Z","last_updated_date":"2021-01-29T15:04:00Z","reference_number":"EMA/CVMP/IWP/600275/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-revision-guideline-data-requirements-multi-strain-dossiers-inactivated-vaccines-against-avian-influenza-ai-blue-tongue-bt-and-foot-and-mouth-disease-fmd-revision-2_en.pdf"},
    {"id":"49979","name":"Draft concept paper for the development of a guideline on data requirements for vaccine antigen master files (VAMF)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-29 - 2021-03-31","first_published_date":"2021-01-29T15:01:00Z","last_updated_date":"2021-01-29T15:01:00Z","reference_number":"EMA/CVMP/IWP/674640/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-guideline-data-requirements-vaccine-antigen-master-files-vamf_en.pdf"},
    {"id":"49980","name":"Draft concept paper for the development of a guideline on data requirements for vaccine platform technology master files (PTMF)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-29 - 2021-03-31","first_published_date":"2021-01-29T15:03:00Z","last_updated_date":"2021-01-29T15:03:00Z","reference_number":"EMA/CVMP/IWP/582191/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-guideline-data-requirements-vaccine-platform-technology-master-files-ptmf_en.pdf"},
    {"id":"49981","name":"Draft concept paper on the provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-01-29 - 2021-03-31","first_published_date":"2021-01-29T15:06:00Z","last_updated_date":"2021-01-29T15:06:00Z","reference_number":"EMA/CVMP/IWP/671155/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-provision-field-efficacy-studies-support-marketing-authorisation-applications-immunological-veterinary-medicinal-products-and-indications-veterinary-vaccines_en.pdf"},
    {"id":"50010","name":"Draft European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-02-01 - 2021-04-30","first_published_date":"2021-02-01T11:41:00Z","last_updated_date":"2021-02-01T11:41:00Z","reference_number":"EMA/HMPC/486551/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-orthosiphon-aristatus-blume-miq-var-aristatus-folium-revision-1_en.pdf"},
    {"id":"50017","name":"Draft public statement on Salvia miltiorrhiza Bunge, radix et rhizoma - First version","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2021-01-29 - 2021-04-30","first_published_date":"2021-02-01T12:30:00Z","last_updated_date":"2021-02-01T12:30:00Z","reference_number":"EMA/HMPC/509927/2019","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-salvia-miltiorrhiza-bunge-radix-et-rhizoma-first-version_en.pdf"},
    {"id":"50029","name":"Draft toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-02 - 2021-07-31","first_published_date":"2021-02-02T16:30:00Z","last_updated_date":"2021-02-02T16:30:00Z","reference_number":"EMA/CHMP/BWP/QWP/IWG/694114/2019","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-toolbox-guidance-scientific-elements-and-regulatory-tools-support-quality-data-packages-prime-marketing-authorisation-applications_en.pdf"},
    {"id":"50030","name":"Call for scientific data for the periodic review of the monograph on Arnica montana L., flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-02-01 - 2021-04-30","first_published_date":"2021-02-02T15:45:00Z","last_updated_date":"2021-02-02T15:45:00Z","reference_number":"EMA/HMPC/58504/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-arnica-montana-l-flos_en.pdf"},
    {"id":"50031","name":"Call for scientific data for the periodic review of the monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-02-01 - 2021-04-30","first_published_date":"2021-02-02T15:45:00Z","last_updated_date":"2021-02-02T15:45:00Z","reference_number":"EMA/HMPC/58633/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-camellia-sinensis-l-kuntze-non-fermentatum-folium_en.pdf"},
    {"id":"50032","name":"Call for scientific data for the periodic review of the monograph on Cichorium intybus L., radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-02-01 - 2021-04-30","first_published_date":"2021-02-02T15:45:00Z","last_updated_date":"2021-02-02T15:45:00Z","reference_number":"EMA/HMPC/58690/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-cichorium-intybus-l-radix_en.pdf"},
    {"id":"50033","name":"Call for scientific data for the periodic review of the monograph on Cucurbita pepo L., semen","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-02-01 - 2021-04-30","first_published_date":"2021-02-02T15:45:00Z","last_updated_date":"2021-02-02T15:45:00Z","reference_number":"EMA/HMPC/58701/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-cucurbita-pepo-l-semen_en.pdf"},
    {"id":"50034","name":"Call for scientific data for the periodic review of the monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-02-01 - 2021-04-30","first_published_date":"2021-02-02T15:45:00Z","last_updated_date":"2021-02-02T15:45:00Z","reference_number":"EMA/HMPC/58738/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-curcuma-xanthorrhiza-roxb-c-xanthorrhiza-d-dietrich-rhizoma_en.pdf"},
    {"id":"50046","name":"Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II - Methods for effectiveness evaluation","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-03 - 2021-04-28","first_published_date":"2021-02-03T14:20:00Z","last_updated_date":"2021-02-03T14:20:00Z","reference_number":"EMA/419982/2019","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-xvi-addendum-ii-methods-effectiveness-evaluation_en.pdf"},
    {"id":"50275","name":"Draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-25 - 2021-05-15","first_published_date":"2021-02-25T15:43:00Z","last_updated_date":"2021-02-25T15:43:00Z","reference_number":"EMA/CVMP/52665/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-efficacy-and-target-animal-safety-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019_en.pdf"},
    {"id":"50276","name":"Draft guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-25 - 2021-05-15","first_published_date":"2021-02-25T15:47:00Z","last_updated_date":"2021-02-25T15:47:00Z","reference_number":"EMA/CVMP/59531/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-applications-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019-6_en.pdf"},
    {"id":"50277","name":"Draft guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-25 - 2021-05-15","first_published_date":"2021-02-25T15:52:00Z","last_updated_date":"2021-02-25T15:52:00Z","reference_number":"EMA/CVMP/345237/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-and-residue-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019-6_en.pdf"},
    {"id":"50278","name":"Draft guideline on safety and residue data requirements for the establishment of Maximum Residue Limits in minor species","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-25 - 2021-05-15","first_published_date":"2021-02-25T15:56:00Z","last_updated_date":"2021-02-25T15:56:00Z","reference_number":"EMA/CVMP/345236/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-safety-and-residue-data-requirements-establishment-maximum-residue-limits-minor-species_en.pdf"},
    {"id":"50357","name":"Call for scientific data for the periodic review of the monograph on Eucalypti aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121765/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-eucalypti-aetheroleum_en.pdf"},
    {"id":"50358","name":"Call for scientific data for the periodic review of the monograph on Eucalypti folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121805/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-eucalypti-folium_en.pdf"},
    {"id":"50359","name":"Call for scientific data for the periodic review of the monograph on Fraxini folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121840/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-fraxini-folium_en.pdf"},
    {"id":"50360","name":"Call for scientific data for the periodic review of the monograph on Ginseng radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121842/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-ginseng-radix_en.pdf"},
    {"id":"50361","name":"Call for scientific data for the periodic review of the monograph on Grindeliae herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121845/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-grindeliae-herba_en.pdf"},
    {"id":"50362","name":"Call for scientific data for the periodic review of the monograph on Hippocastani cortex","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121848/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-hippocastani-cortex_en.pdf"},
    {"id":"50363","name":"Call for scientific data for the periodic review of the monograph on Juglandis folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121859/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-juglandis-folium_en.pdf"},
    {"id":"50364","name":"Call for scientific data for the periodic review of the monograph on Levistici radix","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-01 - 2021-05-31","first_published_date":"2021-03-02T14:26:00Z","last_updated_date":"2021-03-02T14:26:00Z","reference_number":"EMA/HMPC/121865/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-levistici-radix_en.pdf"},
    {"id":"50554","name":"Call for scientific data for use in HMPC assessment work on Combination: Hyperici herba and Cimicifugae rhizoma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-15 - 2021-06-14","first_published_date":"2021-03-15T13:10:00Z","last_updated_date":"2021-03-15T13:10:00Z","reference_number":"EMA/HMPC/58287/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-combination-hyperici-herba-and-cimicifugae-rhizoma_en.pdf"},
    {"id":"50555","name":"Call for scientific data for use in HMPC assessment work on on Cnici benedicti herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-03-15 - 2021-06-14","first_published_date":"2021-03-15T13:15:00Z","last_updated_date":"2021-03-15T13:15:00Z","reference_number":"EMA/HMPC/58236/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-cnici-benedicti-herba_en.pdf"},
    {"id":"50735","name":"Call for scientific data for use in HMPC assessment work on Cetraria islandica (L.) Acharius s.l. - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T11:50:00Z","last_updated_date":"2021-03-31T11:50:00Z","reference_number":"EMA/HMPC/145228/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-cetraria-islandica-l-acharius-sl-revision-1_en.pdf"},
    {"id":"50736","name":"Call for scientific data for the periodic review of the monograph on Liquiritiae radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T11:50:00Z","last_updated_date":"2021-03-31T11:50:00Z","reference_number":"EMA/HMPC/145322/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-liquiritiae-radix-revision-1_en.pdf"},
    {"id":"50743","name":"Call for scientific data for the periodic review of the monograph on Marrubii herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T18:23:00Z","last_updated_date":"2021-03-31T18:23:00Z","reference_number":"EMA/HMPC/145543/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-marrubii-herba-revision-1_en.pdf"},
    {"id":"50744","name":"Call for scientific data for the periodic review of the monograph on Origani dictamni herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T11:46:00Z","last_updated_date":"2021-03-31T11:46:00Z","reference_number":"EMA/HMPC/147922/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-origani-dictamni-herba-revision-1_en.pdf"},
    {"id":"50745","name":"Call for scientific data for the periodic review of the monograph on Paulliniae semen - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T11:44:00Z","last_updated_date":"2021-03-31T11:44:00Z","reference_number":"EMA/HMPC/145594/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-paulliniae-semen-revision-1_en.pdf"},
    {"id":"50746","name":"Call for scientific data for the periodic review of the monograph on Rhodiolae roseae rhizoma et radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T11:41:00Z","last_updated_date":"2021-03-31T11:41:00Z","reference_number":"EMA/HMPC/145602/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-rhodiolae-roseae-rhizoma-et-radix-revision-1_en.pdf"},
    {"id":"50747","name":"Call for scientific data for the periodic review of the monograph on Urticae radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T12:04:00Z","last_updated_date":"2021-03-31T12:04:00Z","reference_number":"EMA/HMPC/146382/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-urticae-radix-revision-1_en.pdf"},
    {"id":"50748","name":"Call for scientific data for the periodic review of the monograph on Tiliae flos - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-04-01 - 2021-06-30","first_published_date":"2021-03-31T11:33:00Z","last_updated_date":"2021-03-31T11:33:00Z","reference_number":"EMA/HMPC/146356/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-tiliae-flos-revision-1_en.pdf"},
    {"id":"50877","name":"Draft European Union herbal monograph on Trigonella foenum-graecum L., semen - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-04-15 - 2021-07-15","first_published_date":"2021-04-16T10:59:00Z","last_updated_date":"2021-04-16T10:59:00Z","reference_number":"EMA/HMPC/179591/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-trigonella-foenum-graecum-l-semen-revision-1_en.pdf"},
    {"id":"50883","name":"Second draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1","type":"herbal-opinion","status":"Draft: consultation closed","consultation_date":"2021-04-15 - 2021-07-15","first_published_date":"2021-04-16T12:29:00Z","last_updated_date":"2021-04-16T12:29:00Z","reference_number":"EMA/HMPC/7695/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/second-draft-european-union-herbal-monograph-hypericum-perforatum-l-herba-traditional-use-revision-1_en.pdf"},
    {"id":"50884","name":"Second draft list of references supporting the assessment of Hypericum perforatum L., herba - Revision 1","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2021-04-15 - 2021-07-15","first_published_date":"2021-04-16T12:31:00Z","last_updated_date":"2021-04-16T12:31:00Z","reference_number":"EMA/HMPC/45511/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/second-draft-list-references-supporting-assessment-hypericum-perforatum-l-herba-revision-1_en.pdf"},
    {"id":"50885","name":"Second draft assessment report on Hypericum perforatum L., herba - Revision 1","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2021-04-15 - 2021-07-15","first_published_date":"2021-04-16T12:35:00Z","last_updated_date":"2021-04-16T12:35:00Z","reference_number":"EMA/HMPC/244315/2016","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/second-draft-assessment-report-hypericum-perforatum-l-herba-revision-1_en.pdf"},
    {"id":"50979","name":"Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-04-22 - 2021-05-31","first_published_date":"2021-04-26T11:33:00Z","last_updated_date":"2021-04-26T11:33:00Z","reference_number":"EMA/CVMP/EWP/165592/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-summary-product-characteristics-anthelmintics_en.pdf-0"},
    {"id":"51202","name":"Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-04-22 - 2021-10-22","first_published_date":"2021-05-20T13:05:00Z","last_updated_date":"2021-05-20T13:05:00Z","reference_number":"EMA/CHMP/ICH/272147/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/addendum-ich-guideline-s1b-testing-carcinogenicity-pharmaceuticals-step-2b_en.pdf"},
    {"id":"51254","name":"Draft reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-05-21 - 2021-07-23","first_published_date":"2021-05-25T15:50:00Z","last_updated_date":"2021-05-25T15:50:00Z","reference_number":"EMA/CVMP/IWP/251741/2015 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-methods-found-suitable-within-eu-demonstrating-freedom-extraneous-agents-seeds-used-production-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"51312","name":"Draft European Union herbal monograph on Vaccinium macrocarpon Aiton, fructus - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-05-31 - 2021-08-31","first_published_date":"2021-05-31T19:39:00Z","last_updated_date":"2021-05-31T19:39:00Z","reference_number":"EMA/HMPC/49135/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-vaccinium-macrocarpon-aiton-fructus-first-version_en.pdf"},
    {"id":"51315","name":"Draft European Union herbal monograph on Taraxacum officinale F.H. Wigg., radix - First version","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-05-31 - 2021-08-31","first_published_date":"2021-05-31T19:48:00Z","last_updated_date":"2021-05-31T19:48:00Z","reference_number":"EMA/HMPC/475726/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-taraxacum-officinale-fh-wigg-radix-first-version_en.pdf"},
    {"id":"51317","name":"Draft public statement on Saccharomyces cerevisiae CBS 5926","type":"public-statement","status":"Draft: consultation closed","consultation_date":"2021-05-31 - 2021-08-31","first_published_date":"2021-05-31T20:00:00Z","last_updated_date":"2021-05-31T20:00:00Z","reference_number":"EMA/HMPC/483588/2020","document_url":"https://www.ema.europa.eu/en/documents/public-statement/draft-public-statement-saccharomyces-cerevisiae-cbs-5926_en.pdf"},
    {"id":"51362","name":"Draft EU VICH adverse event report implementation guide","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-04 - 2021-08-04","first_published_date":"2021-06-04T16:31:00Z","last_updated_date":"2021-06-04T16:31:00Z","reference_number":"EMA/186368/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-eu-vich-adverse-event-report-implementation-guide_en.pdf"},
    {"id":"51374","name":"Draft EU Common Standard for electronic product information for human medicines (ePI)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-07 - 2021-07-31","first_published_date":"2021-06-07T17:32:00Z","last_updated_date":"2021-08-11T13:41:00Z","reference_number":"EMA/319183/2021 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-eu-common-standard-electronic-product-information-human-medicines-epi_en.pdf"},
    {"id":"51434","name":"Call for scientific data for use in HMPC assessment work on Tribuli terrestris herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2021-06-15 - 2021-09-15","first_published_date":"2021-06-15T12:12:00Z","last_updated_date":"2021-06-15T12:12:00Z","reference_number":"EMA/HMPC/291056/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-tribuli-terrestris-herba_en.pdf"},
    {"id":"51584","name":"ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-24 - 2021-10-24","first_published_date":"2021-06-24T16:20:00Z","last_updated_date":"2021-06-24T16:20:00Z","reference_number":"EMA/CHMP/ICH/318372/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ich-guideline-s12-nonclinical-biodistribution-considerations-gene-therapy-products-step-2b_en.pdf"},
    {"id":"51611","name":"Draft guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-25 - 2021-09-30","first_published_date":"2021-06-25T16:03:00Z","last_updated_date":"2021-06-25T16:03:00Z","reference_number":"EMA/CVMP/IWP/105506/2007 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-multi-strain-dossiers-inactivated-veterinary-vaccines_en.pdf"},
    {"id":"51614","name":"Concept paper for the revision of the guideline on requirements for production and control of immunological veterinary medicinal products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-25 - 2021-09-30","first_published_date":"2021-06-25T16:12:00Z","last_updated_date":"2021-06-25T16:12:00Z","reference_number":"EMA/CVMP/IWP/284316/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-requirements-production-and-control-immunological-veterinary-medicinal-products-revision-2_en.pdf"},
    {"id":"51615","name":"Concept paper for the revision of residues guidelines to align with the definitions for withdrawal periods provided in Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-25 - 2021-07-31","first_published_date":"2021-06-25T16:19:00Z","last_updated_date":"2021-06-25T16:19:00Z","reference_number":"EMA/CVMP/SWP/265238/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-residues-guidelines-align-definitions-withdrawal-periods-provided-regulation-eu-2019-6_en.pdf"},
    {"id":"51616","name":"Draft guideline on data requirements for vaccine antigen master files (VAMF)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-06-25 - 2021-09-30","first_published_date":"2021-06-25T16:32:00Z","last_updated_date":"2021-06-25T16:32:00Z","reference_number":"EMA/CVMP/IWP/258755/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-vaccine-antigen-master-files-vamf_en.pdf"},
    {"id":"51704","name":"Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-01 - 2021-08-31","first_published_date":"2021-07-01T10:40:00Z","last_updated_date":"2021-07-01T10:40:00Z","reference_number":"EMA/CHMP/BWP/534898/2008 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials-revision-2_en.pdf"},
    {"id":"51705","name":"Draft guideline on the requirements for the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-01 - 2021-08-31","first_published_date":"2021-07-01T10:46:00Z","last_updated_date":"2021-07-01T10:46:00Z","reference_number":"EMA/CHMP/QWP/545525/2017 Rev. 2 *Corr.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-chemical-and-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-clinical-trials-revision-2_en.pdf"},
    {"id":"51772","name":"Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Collection and recording of suspected adverse events for veterinary medicinal products","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-05 - 2021-09-05","first_published_date":"2021-07-05T12:42:00Z","last_updated_date":"2021-07-05T12:42:00Z","reference_number":"EMA/635856/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-collection-and-recording-suspected-adverse-events-veterinary-medicinal-products_en.pdf"},
    {"id":"51773","name":"Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Controls and pharmacovigilance Inspections","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-05 - 2021-09-05","first_published_date":"2021-07-05T12:50:00Z","last_updated_date":"2021-07-05T12:50:00Z","reference_number":"EMA/328998/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-controls-and-pharmacovigilance-inspections_en.pdf"},
    {"id":"51775","name":"Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-05 - 2021-09-05","first_published_date":"2021-07-05T13:17:00Z","last_updated_date":"2021-07-05T13:17:00Z","reference_number":"EMA/257136/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-pharmacovigilance-systems-their-quality-management-systems-and-pharmacovigilance-system-master-files_en.pdf"},
    {"id":"51776","name":"Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Signal Management","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-05 - 2021-09-05","first_published_date":"2021-07-05T13:20:00Z","last_updated_date":"2021-07-05T13:20:00Z","reference_number":"EMA/399713/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-signal-management_en.pdf"},
    {"id":"51777","name":"Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Veterinary pharmacovigilance communication","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-05 - 2021-09-05","first_published_date":"2021-07-05T13:23:00Z","last_updated_date":"2021-07-05T13:23:00Z","reference_number":"EMA/63454/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-veterinary-pharmacovigilance-communication_en.pdf"},
    {"id":"51972","name":"Concept paper on the development of a guideline on determination of the need for an MRL evaluation for biological substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-09-30","first_published_date":"2021-07-23T18:26:00Z","last_updated_date":"2021-07-23T18:26:00Z","reference_number":"EMA/CVMP/SWP/207500/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-determination-need-mrl-evaluation-biological-substances_en.pdf"},
    {"id":"52030","name":"Draft guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-10-29","first_published_date":"2021-07-23T11:26:00Z","last_updated_date":"2021-07-23T11:26:00Z","reference_number":"EMA/CVMP/IWP/299554/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-authorisation-immunological-veterinary-medicinal-products-under-exceptional-circumstances_en.pdf"},
    {"id":"52031","name":"Draft guideline on clinical trials with immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-10-29","first_published_date":"2021-07-23T14:30:00Z","last_updated_date":"2021-07-23T14:30:00Z","reference_number":"EMA/CVMP/IWP/260956/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-trials-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"52039","name":"Draft guideline on data requirements for vaccine platform technology master files (vPTMF)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-10-29","first_published_date":"2021-07-23T10:44:00Z","last_updated_date":"2021-07-23T10:44:00Z","reference_number":"EMA/CVMP/IWP/286631","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-data-requirements-vaccine-platform-technology-master-files-vptmf_en.pdf"},
    {"id":"52055","name":"Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-09-30","first_published_date":"2021-07-23T15:10:00Z","last_updated_date":"2021-07-23T15:10:00Z","reference_number":"EMA/CVMP/EWP/170208/2005 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-summary-product-characteristics-antiparasitic-veterinary-medicinal-products-revision-1_en.pdf"},
    {"id":"52068","name":"Concept paper on the development of a guideline on the environmental risk assessment of veterinary medicinal products intended to be used in aquaculture","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-10-31","first_published_date":"2021-07-23T18:21:00Z","last_updated_date":"2021-07-23T18:21:00Z","reference_number":"EMA/CVMP/ERA/173026/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-environmental-risk-assessment-veterinary-medicinal-products-intended-be-used-aquaculture_en.pdf"},
    {"id":"52144","name":"Draft guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-30 - 2021-10-31","first_published_date":"2021-07-30T11:00:00Z","last_updated_date":"2021-07-30T11:00:00Z","reference_number":"EMA/CAT/CHMP/158266/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-core-smpc-labelling-and-package-leaflet-advanced-therapy-medicinal-products-atmps-containing-genetically-modified-cells_en.pdf"},
    {"id":"52148","name":"Draft ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-29 - 2021-12-20","first_published_date":"2021-07-29T16:39:00Z","last_updated_date":"2021-07-29T16:39:00Z","reference_number":"EMA/CHMP/ICH/427817/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-q13-continuous-manufacturing-drug-substances-and-drug-products-step-2b_en.pdf"},
    {"id":"52152","name":"Draft assessment report on Species digestivae","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2021-07-31 - 2021-10-31","first_published_date":"2021-07-30T10:31:00Z","last_updated_date":"2021-07-30T10:31:00Z","reference_number":"EMA/HMPC/607773/2017","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-species-digestivae_en.pdf"},
    {"id":"60629","name":"Draft European Union herbal monograph on Species digestivae","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-07-31 - 2021-10-31","first_published_date":"2021-07-30T10:37:00Z","last_updated_date":"2021-07-30T10:37:00Z","reference_number":"EMA/HMPC/180400/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-species-digestivae_en.pdf"},
    {"id":"52153","name":"Draft list of references supporting the assessment of Species digestivae","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2021-07-31 - 2021-10-31","first_published_date":"2021-07-30T10:43:00Z","last_updated_date":"2021-07-30T10:43:00Z","reference_number":"EMA/HMPC/638030/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-species-digestivae_en.pdf"},
    {"id":"52156","name":"Draft assessment report on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2021-07-31 - 2021-10-31","first_published_date":"2021-07-30T15:21:00Z","last_updated_date":"2021-07-30T15:21:00Z","reference_number":"EMA/HMPC/113793/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-agropyron-repens-l-p-beauv-rhizoma-revision-1_en.pdf"},
    {"id":"52157","name":"Draft list of references supporting the assessment of Agropyron repens (L.) P. Beauv., rhizoma - Revision 1","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2021-07-31 - 2021-10-31","first_published_date":"2021-07-30T15:25:00Z","last_updated_date":"2021-07-30T15:25:00Z","reference_number":"EMA/HMPC/117128/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-agropyron-repens-l-p-beauv-rhizoma-revision-1_en.pdf"},
    {"id":"52158","name":"Draft European Union herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-07-31 - 2021-10-31","first_published_date":"2021-07-30T15:27:00Z","last_updated_date":"2021-07-30T15:27:00Z","reference_number":"EMA/HMPC/114726/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-agropyron-repens-l-p-beauv-rhizoma-revision-1_en.pdf"},
    {"id":"52504","name":"Draft reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-09-17 - 2021-12-17","first_published_date":"2021-09-17T16:45:00Z","last_updated_date":"2021-09-17T16:45:00Z","reference_number":"EMA/CVMP/ERA/622045/2020","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-interpretation-article-187-regulation-eu-2019-6_en.pdf"},
    {"id":"52777","name":"Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-08 - 2021-12-08","first_published_date":"2021-10-08T11:27:00Z","last_updated_date":"2021-10-08T11:27:00Z","reference_number":"EMA/CHMP/ICH/502766/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m7-assessment-and-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-addendum-step-2b_en.pdf"},
    {"id":"52856","name":"Draft reflection paper on the interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2022-01-31","first_published_date":"2021-10-15T11:22:00Z","last_updated_date":"2021-10-15T11:22:00Z","reference_number":"EMA/CVMP/ERA/245311/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-interpretation-article-72-regulation-eu-2019-6-environmental-safety-documentation-and-environmental-risk-assessment-certain-veterinary-medicinal-products_en.pdf"},
    {"id":"52866","name":"Draft qualification opinion on IMI PREFER","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2021-11-25","first_published_date":"2021-10-15T13:29:00Z","last_updated_date":"2021-10-15T13:29:00Z","reference_number":"EMADOC-1700519818-732587","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-imi-prefer_en.pdf"},
    {"id":"52870","name":"Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2021-12-15","first_published_date":"2021-10-15T13:45:00Z","last_updated_date":"2021-10-15T13:45:00Z","reference_number":"EMA/CVMP/435071/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-scientific-guidelines-limited-market-products-deemed-not-eligible-authorisation-under-article-23-regulation-2019-6_en.pdf"},
    {"id":"52871","name":"Concept paper on an update to the CVMP’s reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2022-01-31","first_published_date":"2021-10-15T15:15:00Z","last_updated_date":"2021-10-15T15:15:00Z","reference_number":"EMA/CVMP/AWP/266787/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-update-cvmps-reflection-paper-use-macrolides-lincosamides-and-streptogramins-mls-food-producing-animals-european-union-development-resistance-and-impact-human-and-animal-health_en.pdf"},
    {"id":"52872","name":"Draft guideline on determination of withdrawal periods for edible tissues - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2021-12-17","first_published_date":"2021-10-15T16:22:00Z","last_updated_date":"2021-10-15T16:22:00Z","reference_number":"EMA/CVMP/SWP/735325/2012 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-determination-withdrawal-periods-edible-tissues-revision-2_en.pdf"},
    {"id":"52873","name":"Draft guideline on determination of withdrawal periods for milk - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2021-12-17","first_published_date":"2021-10-15T16:28:00Z","last_updated_date":"2021-10-15T16:28:00Z","reference_number":"EMA/CVMP/SWP/735418/2012 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-determination-withdrawal-periods-milk-revision-1_en.pdf"},
    {"id":"52874","name":"Draft guideline on injection site residue - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-10-15 - 2021-12-17","first_published_date":"2021-10-15T16:35:00Z","last_updated_date":"2021-10-15T16:35:00Z","reference_number":"EMA/CVMP/SWP/185470/2004 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-injection-site-residue-revision-1_en.pdf"},
    {"id":"52950","name":"Draft European Union herbal monograph on Centella asiatica (L.) Urb., herba - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2021-10-31 - 2022-01-31","first_published_date":"2021-10-29T15:07:00Z","last_updated_date":"2021-10-29T15:07:00Z","reference_number":"EMA/HMPC/489142/2020","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-centella-asiatica-l-urb-herba-revision-1_en.pdf"},
    {"id":"52983","name":"Draft qualification opinion of Islet Autoantibodies (AAs) as Enrichment Biomarkers for Type 1 Diabetes (T1D) Prevention Clinical Trials","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-11-03 - 2021-12-14","first_published_date":"2021-11-03T18:04:00Z","last_updated_date":"2021-11-03T18:04:00Z","reference_number":"EMA/580542/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-islet-autoantibodies-aas-enrichment-biomarkers-type-1-diabetes-t1d-prevention-clinical-trials_en.pdf"},
    {"id":"53101","name":"Procedural advice for veterinary vaccine antigen master file (VAMF) certification - draft","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-11-12 - 2022-01-12","first_published_date":"2021-11-12T10:32:00Z","last_updated_date":"2021-11-12T10:32:00Z","reference_number":"EMA/127488/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/procedural-advice-veterinary-vaccine-antigen-master-file-vamf-certification-draft_en.pdf"},
    {"id":"53103","name":"Concept paper on the revision of the CVMP Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products (EMEA/CVMP/248499/2007)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-11-12 - 2022-02-28","first_published_date":"2021-11-12T10:48:00Z","last_updated_date":"2021-11-12T10:48:00Z","reference_number":"EMA/CVMP/299406/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-cvmp-recommendation-evaluation-benefit-risk-balance-veterinary-medicinal-products-emea-cvmp-248499-2007_en.pdf"},
    {"id":"53436","name":"Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline Q9 (R1) on quality risk management - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-16 - 2022-03-15","first_published_date":"2021-12-16T10:20:00Z","last_updated_date":"2021-12-16T10:20:00Z","reference_number":"EMA/CHMP/ICH/24235/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-2b_en.pdf"},
    {"id":"53464","name":"Draft guideline on the acceptability of names for human medicinal products processed through the centralised procedure","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-16 - 2022-03-16","first_published_date":"2021-12-16T11:10:00Z","last_updated_date":"2021-12-16T11:10:00Z","reference_number":"EMA/CHMP/287710/2014 Rev. 7","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf"},
    {"id":"53499","name":"Draft ibrutinib hard capsules 140 mg and film-coated tablets 140, 280, 420 & 560 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-16 - 2022-03-31","first_published_date":"2021-12-16T10:30:00Z","last_updated_date":"2021-12-16T10:30:00Z","reference_number":"EMA/CHMP/371445/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ibrutinib-hard-capsules-140-mg-and-film-coated-tablets-140-280-420-560-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"53500","name":"Draft liposomal amphotericin B powder for dispersion for infusion 50 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-17 - 2022-03-31","first_published_date":"2021-12-17T10:20:00Z","last_updated_date":"2021-12-17T10:20:00Z","reference_number":"EMA/CHMP/559889/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-liposomal-amphotericin-b-powder-dispersion-infusion-50-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"53501","name":"Draft ursodeoxycholic acid capsule 250 mg, film-coated tablet 150 mg, 300 mg, 450 mg, 500 mg, 600 mg and suspension 50 mg/ml (250 mg/5 ml) product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-17 - 2022-03-31","first_published_date":"2021-12-17T10:20:00Z","last_updated_date":"2021-12-17T10:20:00Z","reference_number":"EMA/CHMP/559890/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ursodeoxycholic-acid-capsule-250-mg-film-coated-tablet-150-mg-300-mg-450-mg-500-mg-600-mg-and-suspension-50-mg-ml-250-mg-5-ml-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"53502","name":"Draft olaparib 100 mg & 150 mg film-coated tablets product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-16 - 2022-03-31","first_published_date":"2021-12-16T10:30:00Z","last_updated_date":"2021-12-16T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-olaparib-100-mg-150-mg-film-coated-tablets-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"53503","name":"Draft enzalutamide soft capsule 40 mg and film-coated tablet 40 mg & 80 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-15 - 2022-03-31","first_published_date":"2021-12-15T11:00:00Z","last_updated_date":"2021-12-15T11:00:00Z","reference_number":"EMA/CHMP/371467/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-enzalutamide-soft-capsule-40-mg-and-film-coated-tablet-40-mg-80-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"53581","name":"Draft guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-12-20 - 2022-02-20","first_published_date":"2021-12-20T11:27:00Z","last_updated_date":"2021-12-20T11:27:00Z","reference_number":"EMA/747623/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guidance-procedural-aspects-consultation-european-medicines-agency-notified-body-companion-diagnostics_en.pdf"},
    {"id":"53965","name":"Draft guideline on determination of the need for an MRL evaluation for biological substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-01-28 - 2022-04-29","first_published_date":"2022-01-28T10:00:00Z","last_updated_date":"2022-01-28T10:00:00Z","reference_number":"EMA/CVMP/SWP/591282/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-determination-need-mrl-evaluation-biological-substances_en.pdf"},
    {"id":"53966","name":"Draft guideline on requirements for the production and control of immunological veterinary medicinal products - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-01-19 - 2022-03-28","first_published_date":"2022-01-28T16:05:00Z","last_updated_date":"2022-01-28T16:05:00Z","reference_number":"EMA/CVMP/IWP/206555/2010-Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-requirements-production-and-control-immunological-veterinary-medicinal-products-revision-2_en.pdf"},
    {"id":"53998","name":"Draft guideline on clinical trials with immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-07-23 - 2021-10-29","first_published_date":"2021-07-23T13:26:00Z","last_updated_date":"2021-07-23T13:26:00Z","reference_number":"EMA/CVMP/IWP/260956/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-trials-immunological-veterinary-medicinal-products_en.pdf-0"},
    {"id":"60630","name":"Concept paper on the need for amendment of Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Annex on the concomitant use of Veterinary Medicinal Products and biocides.","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-01-28 - 2022-04-30","first_published_date":"2022-01-28T15:15:00Z","last_updated_date":"2022-01-28T15:15:00Z","reference_number":"EMA/CVMP/QWP/697426/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-need-amendment-guideline-quality-aspects-pharmaceutical-veterinary-medicines-administration-drinking-water-annex-concomitant-use-veterinary-medicinal-products-and-biocides_en.pdf"},
    {"id":"54020","name":"Concept paper on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-01-28 - 2022-04-29","first_published_date":"2022-01-28T16:35:00Z","last_updated_date":"2022-01-28T16:35:00Z","reference_number":"EMA/CVMP/NTWP/470741/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-and-data-requirements-potency-tests-cell-based-therapy-products-and-relation-clinical-efficacy_en.pdf"},
    {"id":"54022","name":"Concept paper on quality, safety and efficacy of bacteriophages as veterinary medicines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-01-28 - 2022-04-29","first_published_date":"2022-01-28T16:45:00Z","last_updated_date":"2022-01-28T16:45:00Z","reference_number":"EMA/CVMP/NTWP/438290/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-quality-safety-and-efficacy-bacteriophages-veterinary-medicines_en.pdf"},
    {"id":"54040","name":"Draft VICH GL18 (R2) Impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-01-31 - 2022-06-10","first_published_date":"2022-01-31T14:56:00Z","last_updated_date":"2022-01-31T14:56:00Z","reference_number":"EMA/CVMP/VICH/502/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl18-r2-impurities-residual-solvents-new-veterinary-medicinal-products-active-substances-and-excipients-revision-2_en.pdf"},
    {"id":"54157","name":"Call for scientific data for the periodic review of the monograph on Agrimoniae herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T10:17:00Z","last_updated_date":"2022-02-15T10:17:00Z","reference_number":"EMA/HMPC/72155/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-agrimoniae-herba-revision-1_en.pdf"},
    {"id":"54158","name":"Call for scientific data for the periodic review of the monograph on Capsici fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T10:24:00Z","last_updated_date":"2022-02-15T10:24:00Z","reference_number":"EMA/HMPC/72196/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-capsici-fructus_en.pdf"},
    {"id":"54159","name":"Call for scientific data for the periodic review of the monograph on Crataegi folium cum flore - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T10:28:00Z","last_updated_date":"2022-02-15T10:28:00Z","reference_number":"EMA/HMPC/72203/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-crataegi-folium-cum-flore-revision-1_en.pdf"},
    {"id":"54160","name":"Call for scientific data for the periodic review of the  monograph on Epilobii herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T10:31:00Z","last_updated_date":"2022-02-15T10:31:00Z","reference_number":"EMA/HMPC/72238/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-epilobii-herba_en.pdf"},
    {"id":"54179","name":"Call for scientific data for the periodic review of the monograph on Eschscholziae herba","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T15:56:00Z","last_updated_date":"2022-02-15T15:56:00Z","reference_number":"EMA/HMPC/72283/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-eschscholziae-herba_en.pdf"},
    {"id":"54182","name":"Call for scientific data for the periodic review of the monograph on Ginkgo folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T16:09:00Z","last_updated_date":"2022-02-15T16:09:00Z","reference_number":"EMA/HMPC/72288/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-ginkgo-folium_en.pdf"},
    {"id":"54183","name":"Call for scientific data for the periodic review of the monograph on Helichrysi flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T16:20:00Z","last_updated_date":"2022-02-15T16:20:00Z","reference_number":"EMA/HMPC/72296/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-helichrysi-flos_en.pdf"},
    {"id":"54184","name":"Call for scientific data for the periodic review of the monograph on Matricariae flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-02-15 - 2022-05-14","first_published_date":"2022-02-15T16:25:00Z","last_updated_date":"2022-02-15T16:25:00Z","reference_number":"EMA/HMPC/72301/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-matricariae-flos_en.pdf"},
    {"id":"54253","name":"Draft qualification opinion for the use of Enroll-HD (a Huntington’s disease patient registry) as a data source and infrastructure support for post-authorisation monitoring of medical products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-02-23 - 2022-04-11","first_published_date":"2022-02-23T10:18:00Z","last_updated_date":"2022-02-23T10:18:00Z","reference_number":"EMA/SA/0000056662","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-qualification-opinion-use-enroll-hd-huntingtons-disease-patient-registry-data-source-and-infrastructure-support-post-authorisation-monitoring-medical-products_en.pdf"},
    {"id":"54272","name":"Procaine benzylpenicillin Article-82 referral - Stakeholder submission form","type":"referral","status":"unknown","consultation_date":"2022-02-23 - 2022-09-09","first_published_date":"2022-02-23T16:44:00Z","last_updated_date":"2022-02-23T16:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/procaine-benzylpenicillin-article-82-referral-stakeholder-submission-form_en.pdf"},
    {"id":"54295","name":"Draft reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-02-25 - 2022-05-31","first_published_date":"2022-02-25T10:23:00Z","last_updated_date":"2022-02-25T10:23:00Z","reference_number":"EMA/CVMP/116512/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-criteria-determining-active-substance-essential-when-considered-context-article-372j-regulation-2019-6_en.pdf"},
    {"id":"54430","name":"Call for scientific data for the periodic review of the monograph on Ononidis radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T11:10:00Z","last_updated_date":"2022-03-15T11:10:00Z","reference_number":"EMA/HMPC/120241/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-ononidis-radix-revision-1_en.pdf"},
    {"id":"54432","name":"Call for scientific data for the periodic review of the monograph on Myrtilli fructus siccus - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T11:00:00Z","last_updated_date":"2022-03-15T11:00:00Z","reference_number":"EMA/HMPC/120062/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-myrtilli-fructus-siccus-revision-1_en.pdf"},
    {"id":"54448","name":"Call for scientific data for the periodic review of the monograph on Polygoni avicularis herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T18:05:00Z","last_updated_date":"2022-03-15T18:05:00Z","reference_number":"EMA/HMPC/121979/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-polygoni-avicularis-herba-revision-1_en.pdf"},
    {"id":"54449","name":"Call for scientific data for the periodic review of the monograph on Pruni africanae cortex - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T18:11:00Z","last_updated_date":"2022-03-15T18:11:00Z","reference_number":"EMA/HMPC/122008/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-pruni-africanae-cortex-revision-1_en.pdf"},
    {"id":"54453","name":"Call for scientific data for the periodic review of the  monograph on Pilosellae herba cum radice - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T18:29:00Z","last_updated_date":"2022-03-15T18:29:00Z","reference_number":"EMA/HMPC/121970/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-pilosellae-herba-cum-radice-revision-1_en.pdf"},
    {"id":"54455","name":"Call for scientific data for the periodic review of the  monograph on Origani majoranae herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T18:34:00Z","last_updated_date":"2022-03-15T18:34:00Z","reference_number":"EMA/HMPC/121934/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-origani-majoranae-herba-revision-1_en.pdf"},
    {"id":"54456","name":"Call for scientific data for the periodic review of the  monograph on Myrtilli fructus recens - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-03-15 - 2022-06-14","first_published_date":"2022-03-15T18:38:00Z","last_updated_date":"2022-03-15T18:38:00Z","reference_number":"EMA/HMPC/120142/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-myrtilli-fructus-recens-revision-1_en.pdf"},
    {"id":"54536","name":"Draft qualification opinion for prognostic covariate adjustment (PROCOVA™)","type":"other","status":"Draft: consultation closed","consultation_date":"2022-03-22 - 2022-05-02","first_published_date":"2022-03-22T16:30:00Z","last_updated_date":"2022-03-22T16:30:00Z","reference_number":"Case No.: EMA/SA/0000059571","document_url":"https://www.ema.europa.eu/en/documents/other/draft-qualification-opinion-prognostic-covariate-adjustment-procovatm_en.pdf"},
    {"id":"54567","name":"Concept paper on the elaboration of guidance for the application of Article 34 of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-03-25 - 2022-04-30","first_published_date":"2022-03-25T10:20:00Z","last_updated_date":"2022-03-25T10:20:00Z","reference_number":"EMA/CVMP/65618/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-elaboration-guidance-application-article-34-regulation-eu-2019-6_en.pdf"},
    {"id":"54646","name":"ICH guideline Q2(R2) on validation of analytical procedures - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-03-31 - 2022-07-31","first_published_date":"2022-04-01T11:17:00Z","last_updated_date":"2022-04-01T11:17:00Z","reference_number":"EMA/CHMP/ICH/82072/2006","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf"},
    {"id":"54647","name":"ICH guideline Q14 on analytical procedure development - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-03-31 - 2022-07-31","first_published_date":"2022-04-01T11:29:00Z","last_updated_date":"2022-04-01T11:29:00Z","reference_number":"EMA/CHMP/ICH/195040/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q14-analytical-procedure-development-step-2b_en.pdf"},
    {"id":"54659","name":"Draft paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-04-04 - 2022-07-31","first_published_date":"2022-04-04T12:12:00Z","last_updated_date":"2022-04-04T12:12:00Z","reference_number":"EMA/CHMP/356877/2022 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-paracetamol-oral-use-immediate-release-formulations-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"54660","name":"Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-04-04 - 2022-07-31","first_published_date":"2022-04-04T12:27:00Z","last_updated_date":"2022-04-04T12:27:00Z","reference_number":"EMA/CHMP/315234/2014 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-tadalafil-film-coated-tablets-25-mg-5-mg-10-mg-and-20-mg-product-specific-bioequivalence-guidance-revision-2_en.pdf"},
    {"id":"54663","name":"Draft ibuprofen oral use immediate release formulations 200 – 800 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-04-04 - 2022-07-31","first_published_date":"2022-04-04T14:26:00Z","last_updated_date":"2022-04-04T14:26:00Z","reference_number":"EMA/CHMP/356876/2017 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ibuprofen-oral-use-immediate-release-formulations-200-800-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"54686","name":"Draft ICH guideline E11A on pediatric extrapolation Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-04-06 - 2022-08-06","first_published_date":"2022-04-06T16:07:00Z","last_updated_date":"2022-04-06T16:07:00Z","reference_number":"EMA/CHMP/ICH/205218/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-e11a-pediatric-extrapolation-step-2b_en.pdf"},
    {"id":"54711","name":"Draft guidance document on how to approach the protection of personal data and commercially confidential information in documents uploaded and published in the Clinical Trial Information System (CTIS)","type":"other","status":"Draft: consultation closed","consultation_date":"2022-04-08 - 2022-09-08","first_published_date":"2022-04-08T18:17:00Z","last_updated_date":"2022-04-08T18:17:00Z","reference_number":"EMA/212507/2021","document_url":"https://www.ema.europa.eu/en/documents/other/draft-guidance-document-how-approach-protection-personal-data-and-commercially-confidential-information-documents-uploaded-and-published-clinical-trial-information-system-ctis_en.pdf"},
    {"id":"54742","name":"Call for scientific data for the periodic review of the monograph on Ricini oleum - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-04-15 - 2022-07-14","first_published_date":"2022-04-13T13:30:00Z","last_updated_date":"2022-04-13T13:30:00Z","reference_number":"EMA/HMPC/201470/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-ricini-oleum-revision-1_en.pdf"},
    {"id":"54743","name":"Call for scientific data for the periodic review of the monograph on Rosae flos - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-04-15 - 2022-07-14","first_published_date":"2022-04-13T13:30:00Z","last_updated_date":"2022-04-13T13:30:00Z","reference_number":"EMA/HMPC/201700/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-rosae-flos-revision-1_en.pdf"},
    {"id":"54744","name":"Call for scientific data for the periodic review of the monograph on Rubi idaei folium - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-04-15 - 2022-07-14","first_published_date":"2022-04-13T13:30:00Z","last_updated_date":"2022-04-13T13:30:00Z","reference_number":"EMA/HMPC/201707/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-rubi-idaei-folium-revision-1_en.pdf"},
    {"id":"54746","name":"Call for scientific data for the periodic review of the  monograph on Sideritis herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-04-15 - 2022-07-14","first_published_date":"2022-04-13T11:12:00Z","last_updated_date":"2022-04-13T11:12:00Z","reference_number":"EMA/HMPC/201708/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-sideritis-herba-revision-1_en.pdf"},
    {"id":"54747","name":"Call for scientific data for the periodic review of the  monograph on Sisymbrii officinalis herba - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-04-15 - 2022-07-14","first_published_date":"2022-04-13T11:17:00Z","last_updated_date":"2022-04-13T11:17:00Z","reference_number":"EMA/HMPC/201713/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-sisymbrii-officinalis-herba-revision-1_en.pdf"},
    {"id":"54748","name":"Call for scientific data for the periodic review of the  monograph on Symphyti radix - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2022-04-15 - 2022-07-14","first_published_date":"2022-04-13T11:21:00Z","last_updated_date":"2022-04-13T11:21:00Z","reference_number":"EMA/HMPC/201716/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-symphyti-radix-revision-1_en.pdf"},
    {"id":"54957","name":"Public consultation concerning the physical attendance and the location of personal residency of the qualified person","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2022-05-13 - 2022-06-13","first_published_date":"2022-05-13T15:34:00Z","last_updated_date":"2022-05-13T15:34:00Z","reference_number":"EMA/INS/169000/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/public-consultation-concerning-physical-attendance-and-location-personal-residency-qualified-person_en.pdf"},
    {"id":"54970","name":"Draft lanreotide acetate, prolonged-release solution for injection in prefilled syringe 60, 90 and 120 mg product specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-05-17 - 2022-08-31","first_published_date":"2022-05-17T12:00:00Z","last_updated_date":"2022-05-17T12:00:00Z","reference_number":"EMA/CHMP/559891/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-lanreotide-acetate-prolonged-release-solution-injection-prefilled-syringe-60-90-and-120-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"54997","name":"N-methyl-pyrrolidone - Article-82 referral - Stakeholder submission form","type":"referral","status":"unknown","consultation_date":"2022-05-18 - 2022-09-13","first_published_date":"2022-05-18T18:33:00Z","last_updated_date":"2022-05-18T18:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/n-methyl-pyrrolidone-article-82-referral-stakeholder-submission-form_en.pdf"},
    {"id":"55025","name":"Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-05-20 - 2022-08-31","first_published_date":"2022-05-20T12:00:00Z","last_updated_date":"2022-05-20T12:00:00Z","reference_number":"EMA/240473/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-required-confirmatory-studies-medicinal-products-treatment-type-2-diabetes-revision-2_en.pdf"},
    {"id":"55033","name":"Draft procedural advice for vaccine platform technology master file (vPTMF) certification","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-05-20 - 2022-07-20","first_published_date":"2022-05-20T12:47:00Z","last_updated_date":"2022-05-20T12:47:00Z","reference_number":"EMA/CVMP/184591/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-procedural-advice-vaccine-platform-technology-master-file-vptmf-certification_en.pdf"},
    {"id":"55356","name":"VICH GL7 Efficacy of anthelmintics: general requirements - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:24:00Z","last_updated_date":"2022-06-24T12:24:00Z","reference_number":"EMA/CVMP/VICH/832/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl7-efficacy-anthelmintics-general-requirements-revision-1_en.pdf"},
    {"id":"55357","name":"VICH GL21: Efficacy of anthelmintics: specific recommendations for chickens – gallus gallus  - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/546/2000","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl21-efficacy-anthelmintics-specific-recommendations-chickens-gallus-gallus-revision-1_en.pdf"},
    {"id":"55358","name":"VICH GL20: Efficacy of anthelmintics: specific recommendations for felines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/545/2000","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl20-efficacy-anthelmintics-specific-recommendations-felines-revision-1_en.pdf"},
    {"id":"55359","name":"VICH GL19: Efficacy of anthelmintics: specific recommendations for canines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/835/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl19-efficacy-anthelmintics-specific-recommendations-canines-revision-1_en.pdf"},
    {"id":"55360","name":"VICH GL16: Efficacy of anthelmintics: specific recommendations for porcines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/834/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl16-efficacy-anthelmintics-specific-recommendations-porcines-revision-1_en.pdf"},
    {"id":"55362","name":"VICH GL15: Efficacy of anthelmintics: specific recommendations for equines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/833/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl15-efficacy-anthelmintics-specific-recommendations-equines-revision-1_en.pdf"},
    {"id":"55363","name":"VICH GL14: Efficacy of anthelmintics: specific recommendations for caprines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/841/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl14-efficacy-anthelmintics-specific-recommendations-caprines-revision-1_en.pdf"},
    {"id":"55364","name":"VICH GL13: Efficacy of anthelmintics: specific recommendations for ovines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/840/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl13-efficacy-anthelmintics-specific-recommendations-ovines-revision-1_en.pdf"},
    {"id":"55365","name":"VICH GL12: Efficacy of anthelmintics: specific recommendations for bovines - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-24 - 2022-11-01","first_published_date":"2022-06-24T12:30:00Z","last_updated_date":"2022-06-24T12:30:00Z","reference_number":"EMA/CVMP/VICH/839/1999","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl12-efficacy-anthelmintics-specific-recommendations-bovines-revision-1_en.pdf"},
    {"id":"55412","name":"Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides residues in food of animal origin","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2022-06-30 - 2022-09-13","first_published_date":"2022-06-30T18:00:00Z","last_updated_date":"2022-08-01T15:28:00Z","reference_number":"EMA/CVMP/499555/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-report-development-harmonised-approach-exposure-assessment-methodologies-residues-veterinary-medicinal-products-feed-additives-and-pesticides-residues-food-animal-origin_en.pdf"},
    {"id":"55611","name":"Draft ICH guideline M12 on drug interaction studies - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-07-21 - 2022-11-21","first_published_date":"2022-07-21T13:40:00Z","last_updated_date":"2022-07-21T13:40:00Z","reference_number":"EMA/CHMP/ICH/652460/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m12-drug-interaction-studies-step-2b_en.pdf"},
    {"id":"60631","name":"Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2022-07-22 - 2022-10-31","first_published_date":"2022-07-22T15:41:00Z","last_updated_date":"2022-07-22T15:41:00Z","reference_number":"EMA/CVMP/273040/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-application-article-34-regulation-eu-2019-6-classification-veterinary-medicinal-products-prescription-status_en.pdf"},
    {"id":"55687","name":"Concept paper on the revision of the guideline on the chemistry of active substances - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-07-26 - 2022-10-31","first_published_date":"2022-07-26T17:11:00Z","last_updated_date":"2022-07-26T17:11:00Z","reference_number":"EMA/CHMP/600383/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-chemistry-active-substances-revision-1_en.pdf"},
    {"id":"55878","name":"Final European Union herbal monograph on Juniperus communis L., pseudo-fructus (galbulus) - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"2022-08-31 - 2022-11-30","first_published_date":"2022-08-31T17:47:00Z","last_updated_date":"2023-06-13T13:04:00Z","reference_number":"EMA/HMPC/241320/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-juniperus-communis-l-pseudo-fructus-galbulus-revision-1_en.pdf"},
    {"id":"55879","name":"Final assessment report on Juniperus communis L., pseudo-fructus (galbulus) - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"2022-08-31 - 2022-11-30","first_published_date":"2022-08-31T17:50:00Z","last_updated_date":"2023-06-13T13:13:00Z","reference_number":"EMA/HMPC/241319/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-juniperus-communis-l-pseudo-fructus-galbulus-revision-1_en.pdf"},
    {"id":"55880","name":"Final list of references supporting the assessment of Juniperus communis L., pseudo-fructus (galbulus) - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"2022-08-31 - 2022-11-30","first_published_date":"2022-08-31T17:54:00Z","last_updated_date":"2023-06-13T13:14:00Z","reference_number":"EMA/HMPC/241321/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-juniperus-communis-l-pseudo-fructus-galbulus-revision-1_en.pdf"},
    {"id":"56098","name":"Concept paper on the establishment of a guideline on the development and manufacture of synthetic oligonucleotides","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-09-20 - 2022-12-20","first_published_date":"2022-09-20T12:52:00Z","last_updated_date":"2022-09-20T12:52:00Z","reference_number":"EMA/CHMP/QWP/735423/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-establishment-guideline-development-and-manufacture-synthetic-oligonucleotides_en.pdf"},
    {"id":"56099","name":"Concept paper on the establishment of a guideline on the development and manufacture of synthetic peptides","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-09-20 - 2022-12-20","first_published_date":"2022-09-20T12:53:00Z","last_updated_date":"2022-09-20T12:53:00Z","reference_number":"EMA/CHMP/QWP/735422/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-establishment-guideline-development-and-manufacture-synthetic-peptides_en.pdf"},
    {"id":"56118","name":"Concept paper on a guideline on data requirements for post-authorisation studies for antimicrobial veterinary medicinal products under Article 36(2) of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-09-16 - 2023-01-31","first_published_date":"2022-09-16T11:16:00Z","last_updated_date":"2022-09-16T11:16:00Z","reference_number":"EMA/CVMP/AWP/201064/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-data-requirements-post-authorisation-studies-antimicrobial-veterinary-medicinal-products-under-article-362-regulation-eu-2019-6_en.pdf"},
    {"id":"56351","name":"ICH: Q 5 A (R2): Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-10-10 - 2023-02-10","first_published_date":"2022-10-10T11:45:00Z","last_updated_date":"2022-10-10T11:45:00Z","reference_number":"EMA/CHMP/ICH/804363/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-5-r2-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-step-2b_en.pdf"},
    {"id":"56482","name":"ICH M11 technical specification - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-10-26 - 2023-02-26","first_published_date":"2022-10-26T13:15:00Z","last_updated_date":"2022-10-26T13:15:00Z","reference_number":"EMA/CHMP/ICH/778800/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m11-technical-specification-step-2b_en.pdf"},
    {"id":"56483","name":"ICH M11 template - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-10-26 - 2023-02-26","first_published_date":"2022-10-26T13:13:00Z","last_updated_date":"2022-10-26T13:13:00Z","reference_number":"EMA/CHMP/ICH/778801/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m11-template-step-2b_en.pdf"},
    {"id":"56509","name":"Draft European Union herbal monograph on Fumaria officinalis L., herba – Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2022-10-31 - 2023-01-31","first_published_date":"2022-10-31T10:35:00Z","last_updated_date":"2022-10-31T10:35:00Z","reference_number":"EMA/HMPC/367011/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-fumaria-officinalis-l-herba-revision-1_en.pdf"},
    {"id":"56510","name":"Draft List of references supporting the assessment of Fumaria officinalis L., herba – Revision 1","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2022-10-31 - 2023-01-31","first_published_date":"2022-10-31T10:39:00Z","last_updated_date":"2022-10-31T10:39:00Z","reference_number":"EMA/HMPC/367012/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-fumaria-officinalis-l-herba-revision-1_en.pdf"},
    {"id":"56511","name":"Draft Assessment report on Fumaria officinalis L. herba– Revision 1","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2022-10-31 - 2023-01-31","first_published_date":"2022-10-31T10:49:00Z","last_updated_date":"2022-10-31T10:49:00Z","reference_number":"EMA/HMPC/367013/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-fumaria-officinalis-l-herba-revision-1_en.pdf"},
    {"id":"56512","name":"Concept paper on the revision of the guideline on the assessment of genotoxicity of herbal substances/preparations (EMEA/HMPC/107079/2007)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-10-31 - 2023-01-31","first_published_date":"2022-10-31T11:26:00Z","last_updated_date":"2022-10-31T11:26:00Z","reference_number":"EMA/HMPC/41456/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-assessment-genotoxicity-herbal-substances-preparations-emea-hmpc-107079-2007_en.pdf"},
    {"id":"56581","name":"Concept paper on platform trials","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-11-11 - 2023-01-31","first_published_date":"2022-11-11T11:00:00Z","last_updated_date":"2022-11-11T11:00:00Z","reference_number":"EMA/CHMP/840036/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-platform-trials_en.pdf"},
    {"id":"56638","name":"Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2022-11-16 - 2023-01-16","first_published_date":"2022-11-16T10:33:00Z","last_updated_date":"2022-11-16T10:33:00Z","reference_number":"EMA/INS/GMP/778340/2022 ","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf"},
    {"id":"56707","name":"Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-11-18 - 2023-05-31","first_published_date":"2022-11-18T11:45:00Z","last_updated_date":"2022-11-18T11:45:00Z","reference_number":"EMA/CHMP/CMDh/CAT/BWP/828612/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-criteria-be-considered-evaluation-new-active-substance-nas-status-biological-substances_en.pdf"},
    {"id":"56711","name":"Draft guideline on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-11-18 - 2023-02-28","first_published_date":"2022-11-18T14:27:00Z","last_updated_date":"2022-11-18T14:27:00Z","reference_number":"EMA/CVMP/NTWP/179287/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-and-data-requirements-potency-tests-cell-based-therapy-products-and-relation-clinical-efficacy_en.pdf"},
    {"id":"57096","name":"Concept paper on a guideline on risk management requirements for elemental impurities in veterinary medicinal products, including immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2022-12-19 - 2023-03-31","first_published_date":"2022-12-19T11:12:00Z","last_updated_date":"2022-12-19T11:12:00Z","reference_number":"EMA/CVMP/637041/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-guideline-risk-management-requirements-elemental-impurities-veterinary-medicinal-products-including-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"57435","name":"Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy","type":"scientific-guideline","status":"Adopted","consultation_date":"2023-01-27 - 2023-05-31","first_published_date":"2023-01-27T12:52:00Z","last_updated_date":"2023-10-13T17:25:00Z","reference_number":"EMA/CVMP/NTWP/32862/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-safety-and-efficacy-veterinary-medicinal-products-specifically-designed-phage-therapy_en.pdf"},
    {"id":"57552","name":"ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-01-26 - 2023-05-26","first_published_date":"2023-02-07T18:23:00Z","last_updated_date":"2023-02-07T18:23:00Z","reference_number":"EMA/CHMP/ICH953493/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-step-2b_en.pdf"},
    {"id":"57654","name":"Concept paper on revision of the ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-03-01 - 2023-05-31","first_published_date":"2023-02-14T17:18:00Z","last_updated_date":"2023-02-14T17:18:00Z","reference_number":"EMA/HMPC/888811/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-declaration-herbal-substances-and-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"57672","name":"Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops)","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-02-15 - 2023-05-14","first_published_date":"2023-02-15T11:02:00Z","last_updated_date":"2023-02-15T11:02:00Z","reference_number":"EMA/HMPC/697513/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-cannabis-sativa-l-flos-cannabis-sativa-flowering-tops_en.pdf"},
    {"id":"57681","name":"Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘cough and cold’","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-02-15 - 2023-05-14","first_published_date":"2023-02-15T16:35:00Z","last_updated_date":"2023-02-15T16:35:00Z","reference_number":"EMA/HMPC/68490/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-herbal-tea-combinations-traditionally-used-therapeutic-area-cough-and-cold_en.pdf"},
    {"id":"57682","name":"Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-02-15 - 2023-05-14","first_published_date":"2023-02-15T16:35:00Z","last_updated_date":"2023-02-15T16:35:00Z","reference_number":"EMA/HMPC/68488/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-pruni-cerasi-stipites_en.pdf"},
    {"id":"57853","name":"Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2023-02-28 - 2023-04-10","first_published_date":"2023-03-01T18:18:00Z","last_updated_date":"2023-03-01T18:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-qualification-opinion-stride-velocity-95th-centile-primary-endpoint-studies-ambulatory-duchenne-muscular-dystrophy_en.pdf"},
    {"id":"58240","name":"Call for scientific data for the periodic review of the monograph on Lecithinum ex soya - Revision 1","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-03-31 - 2023-06-30","first_published_date":"2023-03-31T10:49:00Z","last_updated_date":"2023-03-31T10:49:00Z","reference_number":"EMA/HMPC/141083/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-lecithinum-ex-soya-revision-1_en.pdf"},
    {"id":"58243","name":"Call for scientific data for the periodic review of the monograph on Matricariae aetheroleum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-03-31 - 2023-06-30","first_published_date":"2023-03-31T12:41:00Z","last_updated_date":"2023-03-31T12:41:00Z","reference_number":"EMA/HMPC/141099/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-matricariae-aetheroleum_en.pdf"},
    {"id":"58244","name":"Call for scientific data for the periodic review of the monograph on Soiae oleum raffinatum","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-03-31 - 2023-06-30","first_published_date":"2023-03-31T12:51:00Z","last_updated_date":"2023-03-31T12:51:00Z","reference_number":"EMA/HMPC/141196/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-soiae-oleum-raffinatum_en.pdf"},
    {"id":"58245","name":"Call for scientific data for the periodic review of the monograph on Malvae sylvestris flos","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-03-31 - 2023-06-30","first_published_date":"2023-03-31T12:55:00Z","last_updated_date":"2023-03-31T12:55:00Z","reference_number":"EMA/HMPC/141161/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-malvae-sylvestris-flos_en.pdf"},
    {"id":"58249","name":"Call for scientific data for the periodic review of the monograph on Malvae folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-03-31 - 2023-06-30","first_published_date":"2023-03-31T15:29:00Z","last_updated_date":"2023-03-31T15:29:00Z","reference_number":"EMA/HMPC/141175/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-malvae-folium_en.pdf"},
    {"id":"58260","name":"Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-04-01 - 2023-06-30","first_published_date":"2023-03-31T18:31:00Z","last_updated_date":"2023-03-31T18:31:00Z","reference_number":"EMA/CVMP/QWP/592906/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-aspects-pharmaceutical-veterinary-medicines-administration-drinking-water-draft-annex-compatibility-studies-between-veterinary-medicinal-products-and-biocidal-products_en.pdf"},
    {"id":"58556","name":"Call for scientific data for the periodic review of the monograph on Allii sativi bulbus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-04-30 - 2023-07-31","first_published_date":"2023-05-02T13:29:00Z","last_updated_date":"2023-05-02T13:29:00Z","reference_number":"EMA/HMPC/187357/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-allii-sativi-bulbus_en.pdf"},
    {"id":"58558","name":"Call for scientific data for the periodic review of the monograph on Silybi mariani fructus","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-04-30 - 2023-07-31","first_published_date":"2023-05-02T14:30:00Z","last_updated_date":"2023-05-02T14:30:00Z","reference_number":"EMA/HMPC/187481/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-silybi-mariani-fructus_en.pdf"},
    {"id":"58559","name":"Call for scientific data for the periodic review of the monograph on Combination: Species diureticae","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-04-30 - 2023-07-31","first_published_date":"2023-05-02T14:38:00Z","last_updated_date":"2023-05-02T14:38:00Z","reference_number":"EMA/HMPC/187490/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-combination-species-diureticae_en.pdf"},
    {"id":"58588","name":"Concept paper on revision of the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-05-04 - 2023-07-31","first_published_date":"2023-05-04T19:21:00Z","last_updated_date":"2023-05-04T19:21:00Z","reference_number":"EMA/CHMP/175067/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-clinical-investigation-medicinal-products-treatment-patients-acute-respiratory-distress-syndrome_en.pdf"},
    {"id":"58953","name":"Call for scientific data for the use in HMPC assessment work on Maydis stigma","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2023-06-15 - 2023-09-15","first_published_date":"2023-06-15T13:18:00Z","last_updated_date":"2023-06-15T13:18:00Z","reference_number":"EMA/HMPC/267698/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-use-hmpc-assessment-work-maydis-stigma_en.pdf"},
    {"id":"58955","name":"Draft assessment report on Panax ginseng C.A.Mey., radix - Revision 1","type":"herbal-report","status":"Draft","consultation_date":"2023-10-19 - 2024-01-15","first_published_date":"2023-06-15T13:48:00Z","last_updated_date":"2023-10-25T12:15:00Z","reference_number":"EMA/HMPC/27745/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-panax-ginseng-camey-radix-revision-1_en.pdf"},
    {"id":"59043","name":"Bosutinib film-coated tablets 100, 400 and 500 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-22 - 2023-09-30","first_published_date":"2023-06-22T16:40:00Z","last_updated_date":"2023-06-22T16:40:00Z","reference_number":"EMA/CHMP/590937/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/bosutinib-film-coated-tablets-100-400-and-500-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"59044","name":"Fampridine prolonged-release tablet 10 mg product specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-22 - 2023-09-30","first_published_date":"2023-06-22T16:58:00Z","last_updated_date":"2023-06-22T16:58:00Z","reference_number":"EMA/CHMP/39346/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/fampridine-prolonged-release-tablet-10-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"59046","name":"Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-22 - 2023-09-30","first_published_date":"2023-06-22T17:10:00Z","last_updated_date":"2023-06-22T17:10:00Z","reference_number":"EMA/CHMP/39336/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lurasidone-film-coated-tablets-185-37-and-74-mg-4-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"59053","name":"Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-22 - 2023-09-30","first_published_date":"2023-06-22T17:44:00Z","last_updated_date":"2023-06-22T17:44:00Z","reference_number":"EMA/CHMP/901584/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/pirfenidone-film-coated-tablets-267-537-and-801-mg-and-hard-capsules-267-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"59064","name":"Concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-23 - 2023-09-22","first_published_date":"2023-06-23T12:20:00Z","last_updated_date":"2023-06-23T12:20:00Z","reference_number":"EMA/CVMP/IWP/161133/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-live-recombinant-vector-vaccines-veterinary-use_en.pdf"},
    {"id":"59070","name":"Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators","type":"scientific-guideline","status":"Adopted","consultation_date":"2023-06-23 - 2023-07-31","first_published_date":"2023-06-23T13:24:00Z","last_updated_date":"2023-10-13T18:07:00Z","reference_number":"EMA/CVMP/882931/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-antimicrobial-sales-and-use-animals-eu-level-denominators-and-indicators_en.pdf"},
    {"id":"59074","name":"Concept paper on the development of a guideline on the quality aspects of mRNA vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-23 - 2023-09-30","first_published_date":"2023-06-23T14:17:00Z","last_updated_date":"2023-06-23T14:17:00Z","reference_number":"EMA/CHMP/BWP/211968/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-quality-aspects-mrna-vaccines_en.pdf"},
    {"id":"59272","name":"ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-30 - 2023-09-30","first_published_date":"2023-07-06T12:10:00Z","last_updated_date":"2023-07-06T12:10:00Z","reference_number":"EMA/CHMP/ICH/295401/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-reflection-paper-proposed-international-harmonisation-real-world-evidence-terminology-and-convergence-general-principles-regarding-planning-and-reporting-studies-using-real-world-data-focus_en.pdf"},
    {"id":"59454","name":"Concept paper for the development of a reflection paper on the availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-07-21 - 2023-10-31","first_published_date":"2023-07-21T17:28:00Z","last_updated_date":"2023-07-21T17:28:00Z","reference_number":"EMA/CVMP/AWP/933451/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-availability-and-characteristics-diagnostic-tests-improve-responsible-use-antibiotics-animals_en.pdf"},
    {"id":"59455","name":"Concept paper on the revision of the 'Guideline on Radiopharmaceuticals - Revision 1'","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-07-21 - 2023-10-31","first_published_date":"2023-07-21T17:44:00Z","last_updated_date":"2023-07-21T17:44:00Z","reference_number":"EMA/CHMP/QWP/298182/2023 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-radiopharmaceuticals-revision-1_en.pdf"},
    {"id":"59456","name":"Concept paper on the revision of the guideline on 'Guideline on Radiopharmaceuticals based on monoclonal antibodies'","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-07-21 - 2023-10-31","first_published_date":"2023-07-21T17:51:00Z","last_updated_date":"2023-07-21T17:51:00Z","reference_number":"EMA/CHMP/BWP/245588/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-guideline-radiopharmaceuticals-based-monoclonal-antibodies_en.pdf"},
    {"id":"59461","name":"Concept paper on the revision of the guideline for the demonstration of efficacy of ectoparasiticides","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-07-21 - 2023-10-31","first_published_date":"2023-07-21T18:46:00Z","last_updated_date":"2023-07-21T18:46:00Z","reference_number":"EMA/CVMP/EWP/56030/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guideline-demonstration-efficacy-ectoparasiticides_en.pdf"},
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    {"id":"60456","name":"Agenda - Third Veterinary Big Data Stakeholder Forum","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-10-19T17:34:00Z","last_updated_date":"2023-11-22T16:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-third-veterinary-big-data-stakeholder-forum_en.pdf"},
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    {"id":"29200","name":"Withdrawal letter : Lenalidomide Celgene Europe","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:00:00Z","last_updated_date":"2008-05-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-lenalidomide-celgene-europe_en.pdf"},
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    {"id":"3887","name":"Withdrawal letter : Diractin","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2008-07-23T02:00:00Z","last_updated_date":"2008-07-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-diractin_en.pdf"},
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    {"id":"4890","name":"Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR)","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2012-06-11T18:17:00Z","last_updated_date":"2023-11-23T18:17:00Z","reference_number":"EMA/CVMP/88291/2011-corr 1","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/azamethiphos-extension-fin-fish-european-public-maximum-residue-limit-assessment-report-epmar_en.pdf"},
    {"id":"59926","name":"Agenda of the CHMP meeting 11-14 September 2023","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2023-09-11T10:35:00Z","last_updated_date":"2023-09-14T12:36:00Z","reference_number":"EMA/CHMP/355400/2023 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-11-14-september-2023_en.pdf"},
    {"id":"26929","name":"Withdrawal letter : Ramelteon","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2008-09-19T02:00:00Z","last_updated_date":"2008-09-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ramelteon_en.pdf"},
    {"id":"6575","name":"Withdrawal letter : Lacosamide Pain UCB Pharma","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2008-09-25T02:00:00Z","last_updated_date":"2008-09-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-lacosamide-pain-ucb-pharma_en.pdf"},
    {"id":"39866","name":"Withdrawal letter : Ellefore","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2008-10-13T02:00:00Z","last_updated_date":"2008-10-13T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ellefore_en.pdf"},
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    {"id":"25001","name":"Withdrawal letter : Repaglinide Sun","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-04-28T02:00:00Z","last_updated_date":"2010-04-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-repaglinide-sun_en.pdf"},
    {"id":"30368","name":"Withdrawal letter: Tyvaso","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-tyvaso_en.pdf"},
    {"id":"20646","name":"Withdrawal letter : Sliwens","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2009-12-18T01:00:00Z","last_updated_date":"2009-12-18T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-sliwens_en.pdf"},
    {"id":"29461","name":"Withdrawal letter: Brilence","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-06-29T02:00:00Z","last_updated_date":"2010-06-29T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-brilence_en.pdf"},
    {"id":"10769","name":"Withdrawal letter : Gallimune Flu H5N9(i)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-11-16T01:00:00Z","last_updated_date":"2010-11-16T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-gallimune-flu-h5n9i_en.pdf"},
    {"id":"36971","name":"Withdrawal letter : Rasival","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-09-28T02:00:00Z","last_updated_date":"2010-09-28T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-rasival_en.pdf"},
    {"id":"2639","name":"Withdrawal letter : Emerflu","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/792246/2010","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-emerflu_en.pdf"},
    {"id":"23051","name":"Withdrawal letter: Zenhale","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-zenhale_en.pdf"},
    {"id":"39189","name":"Tekinex: Withdrawal letter","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/tekinex-withdrawal-letter_en.pdf"},
    {"id":"35591","name":"Ozespa: Withdrawal letter","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-01-31T01:00:00Z","last_updated_date":"2011-01-31T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/ozespa-withdrawal-letter_en.pdf"},
    {"id":"14807","name":"Withdrawal letter: Cerepro","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2010-03-23T01:00:00Z","last_updated_date":"2010-03-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-cerepro_en.pdf-0"},
    {"id":"25618","name":"Topotecan SUN: Withdrawal letter","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/topotecan-sun-withdrawal-letter_en.pdf"},
    {"id":"3530","name":"Movectro: Withdrawal letter","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/movectro-withdrawal-letter_en.pdf"},
    {"id":"39263","name":"Withdrawal letter : Epostim","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-04-19T02:00:00Z","last_updated_date":"2011-04-19T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-epostim_en.pdf"},
    {"id":"18018","name":"Withdrawal letter: Joicela","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-joicela_en.pdf"},
    {"id":"6645","name":"Withdrawal letter: Beprana","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-05-27T02:00:00Z","last_updated_date":"2011-05-27T02:00:00Z","reference_number":"EMA/364651/2011","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-beprana_en.pdf"},
    {"id":"40212","name":"Withdrawal letter: Ibandronic Acid Hexal","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-08-22T02:00:00Z","last_updated_date":"2011-08-22T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ibandronic-acid-hexal_en.pdf"},
    {"id":"7707","name":"Withdrawal letter: Doxorubicin SUN","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/CHMP/647763/2011","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-doxorubicin-sun_en.pdf"},
    {"id":"16069","name":"Withdrawal letter: Luveniq","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-10-24T02:00:00Z","last_updated_date":"2011-10-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-luveniq_en.pdf"},
    {"id":"33367","name":"Withdrawal letter: Desloratadine Krka","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-11-17T01:00:00Z","last_updated_date":"2011-11-17T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-desloratadine-krka_en.pdf"},
    {"id":"7879","name":"Withdrawal  letter: Janacti","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-11-22T01:00:00Z","last_updated_date":"2011-11-22T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-janacti_en.pdf"},
    {"id":"34825","name":"Withdrawal letter: Kalbitor","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2011-11-23T01:00:00Z","last_updated_date":"2011-11-23T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-kalbitor_en.pdf"},
    {"id":"4557","name":"Withdrawal letter: Megestrol Alkermes (megestrol)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-03-19T01:00:00Z","last_updated_date":"2012-03-19T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-megestrol-alkermes-megestrol_en.pdf"},
    {"id":"39702","name":"Withdrawal letter : Fluad Paediatric","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-02-21T01:00:00Z","last_updated_date":"2012-02-21T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-fluad-paediatric_en.pdf"},
    {"id":"12418","name":"Withdrawal letter: Paccal Vet","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-04-25T02:00:00Z","last_updated_date":"2012-04-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-paccal-vet_en.pdf"},
    {"id":"9540","name":"Withdrawal letter: Pioglitazone ratio","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T02:00:00Z","last_updated_date":"2012-04-30T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-pioglitazone-ratio_en.pdf"},
    {"id":"12267","name":"Withdrawal letter: Pioglitazone ratiopharm GmbH","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-04-30T13:21:00Z","last_updated_date":"2012-04-30T13:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-pioglitazone-ratiopharm-gmbh_en.pdf"},
    {"id":"39205","name":"Withdrawal letter - Oxapex","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-06-25T02:00:00Z","last_updated_date":"2012-06-25T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-oxapex_en.pdf-0"},
    {"id":"7574","name":"Withdrawal letter: Egrifta (tesamorelin)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-07-18T02:00:00Z","last_updated_date":"2012-07-18T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-egrifta-tesamorelin_en.pdf"},
    {"id":"25895","name":"Withdrawal letter: Mulsevo (semuloparin sodium)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-07-20T02:00:00Z","last_updated_date":"2012-07-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-mulsevo-semuloparin-sodium_en.pdf"},
    {"id":"15873","name":"Withdrawal letter: SecreFlo (secretin human)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-09-24T02:00:00Z","last_updated_date":"2012-09-24T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-secreflo-secretin-human_en.pdf"},
    {"id":"34184","name":"Withdrawal letter: Combimarv, Isomarv, Solumarv","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-combimarv-isomarv-solumarv_en.pdf"},
    {"id":"16912","name":"Withdrawal letter: Loulla","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T13:00:00Z","last_updated_date":"2013-01-18T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-loulla_en.pdf"},
    {"id":"36617","name":"Withdrawal letter: Jenzyl (ridaforolimus)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2012-12-14T01:00:00Z","last_updated_date":"2012-12-14T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-jenzyl-ridaforolimus_en.pdf"},
    {"id":"38041","name":"Withdrawal letter: Memantine FGK","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2013-01-18T01:00:00Z","last_updated_date":"2013-01-25T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-memantine-fgk_en.pdf"},
    {"id":"12841","name":"Withdrawal letter: Ruvise","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2013-01-24T15:15:00Z","last_updated_date":"2013-01-24T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ruvise_en.pdf"},
    {"id":"33959","name":"Withdrawal letter: Hyalograft C autograft","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2013-02-26T01:00:00Z","last_updated_date":"2013-02-26T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-hyalograft-c-autograft_en.pdf"},
    {"id":"37336","name":"Withdrawal letter: Fanaptum","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2013-03-14T18:00:00Z","last_updated_date":"2013-03-14T18:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-fanaptum_en.pdf"},
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    {"id":"42380","name":"Perlinring Article-29(4) referral  - EMA recommends authorisation of Perlinring (etonogestrel / ethinylestradiol vaginal ring) in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-10-19T12:43:00Z","last_updated_date":"2019-01-21T15:03:00Z","reference_number":"EMA/720896/2018 Rev 1","document_url":"https://www.ema.europa.eu/en/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/perlinring-article-294-referral-ema-recommends-authorisation-perlinring-etonogestrel-ethinylestradiol-vaginal-ring-eu_sv.pdf"}},
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    {"id":"34800","name":"Xalatan - Article 29 paediatrics - CHMP assessment report","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2010-12-08T01:00:00Z","last_updated_date":"2010-12-08T01:00:00Z","reference_number":"EMA/531707/2010","document_url":"https://www.ema.europa.eu/en/documents/referral/xalatan-article-29-paediatrics-chmp-assessment-report_en.pdf"},
    {"id":"42302","name":"Xofigo Article-20 procedure - CHMP divergent positions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2018-10-11T16:51:00Z","last_updated_date":"2018-10-11T16:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/xofigo-article-20-procedure-chmp-divergent-positions_en.pdf"},
    {"id":"8774","name":"Divergent position on a CVMP opinion on an Article 33.4 referral for\n\nProntax 10 mg/ml solution for injection for sheep, cattle and pigs (EMEA/V/A/073)","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-07-05T02:00:00Z","last_updated_date":"2012-07-05T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-334-referral-prontax-10-mg-ml-solution-injection-sheep-cattle-and-pigs-emea-v-073_en.pdf"},
    {"id":"36124","name":"Divergent position on a CVMP opinion on an Article 34 referral for\n\nMilaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2012-07-23T02:00:00Z","last_updated_date":"2012-07-23T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/divergent-position-cvmp-opinion-article-34-referral-milaxyn-plus-strantel-plus-prazical-plus-voxical-plus-exitel-plus-cazitel-plus-prazitel-plus-and-associated-names_en.pdf"},
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    {"id":"46058","name":"Tylosin injectable for sheep Article-35 referral - Questions and answers on withdrawal periods for injectable veterinary medicines containing tylosin when given to 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    {"id":"57072","name":"Gelisia Article 29(4) referral - EMA recommends authorisation of Gelisia (timolol, eye gel) in the EU","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T10:46:00Z","last_updated_date":"2022-12-16T10:46:00Z","reference_number":"EMA/931490/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/gelisia-article-294-referral-ema-recommends-authorisation-gelisia-timolol-eye-gel-eu_en.pdf"},
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    {"id":"58190","name":"Pholcodine medicines withdrawn from EU market","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-03-29T09:01:00Z","last_updated_date":"2023-03-29T09:01:00Z","reference_number":"EMA/126062/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-medicines-withdrawn-eu-market_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/pholcodine-medicines-withdrawn-eu-market_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/pholcodine-medicines-withdrawn-eu-market_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/pholcodine-medicines-withdrawn-eu-market_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/pholcodine-medicines-withdrawn-eu-market_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/pholcodine-medicines-withdrawn-eu-market_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/pholcodine-medicines-withdrawn-eu-market_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/pholcodine-medicines-withdrawn-eu-market_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/pholcodine-medicines-withdrawn-eu-market_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/pholcodine-medicines-withdrawn-eu-market_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/pholcodine-medicines-withdrawn-eu-market_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/pholcodine-medicines-withdrawn-eu-market_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/pholcodine-medicines-withdrawn-eu-market_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/pholcodine-medicines-withdrawn-eu-market_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/pholcodine-medicines-withdrawn-eu-market_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/pholcodine-medicines-withdrawn-eu-market_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/pholcodine-medicines-withdrawn-eu-market_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/pholcodine-medicines-withdrawn-eu-market_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/pholcodine-medicines-withdrawn-eu-market_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/pholcodine-medicines-withdrawn-eu-market_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/pholcodine-medicines-withdrawn-eu-market_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/pholcodine-medicines-withdrawn-eu-market_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/pholcodine-medicines-withdrawn-eu-market_sv.pdf"}},
    {"id":"60807","name":"Agenda - Eleventh meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T10:45:00Z","last_updated_date":"2023-11-22T12:00:00Z","reference_number":"EMA/501563/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eleventh-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicines_en.pdf"},
    {"id":"55960","name":"Pholcodine-containing medicinal products Article-107i referral - EMA recommends withdrawal of pholcodine medicines from EU market","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-09-02T15:43:00Z","last_updated_date":"2022-12-02T12:06:00Z","reference_number":"EMA/906150/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/pholcodine-containing-medicinal-products-article-107i-referral-ema-recommends-withdrawal-pholcodine-medicines-eu-market_en.pdf"},
    {"id":"57044","name":"EMA recommends withdrawal of pholcodine medicines from EU market","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2022-12-16T15:34:00Z","last_updated_date":"2022-12-16T15:34:00Z","reference_number":"EMA/906150/2022","document_url":"https://www.ema.europa.eu/en/documents/referral/ema-recommends-withdrawal-pholcodine-medicines-eu-market_en.pdf"},
    {"id":"61016","name":"Presentation - Update on digitalization: eAF & IRIS Focus (K. Puusaari, F. Penaranda, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:19:15Z","last_updated_date":"2023-11-28T15:19:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-digitalization-eaf-iris-focus-k-puusaari-f-penaranda-ema_en.pdf"},
    {"id":"61018","name":"Presentation - Patient experience data (R. Gonzalez Quevedo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:27:49Z","last_updated_date":"2023-11-28T15:27:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"61019","name":"Presentation - Working parties and new ways of working (S. da Rocha, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:32:11Z","last_updated_date":"2023-11-28T15:32:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-working-parties-and-new-ways-working-s-da-rocha-ema_en.pdf"},
    {"id":"61020","name":"Presentation - Update on issues raised during Validation of Type IB and Type II Variations (E. Merken, S. Pulido Sanchez, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:34:48Z","last_updated_date":"2023-11-28T15:34:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-issues-raised-during-validation-type-ib-and-type-ii-variations-e-merken-s-pulido-sanchez-ema_en.pdf"},
    {"id":"61021","name":"Presentation - Windsor protocol implementation aspects (T. Girard, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:37:35Z","last_updated_date":"2023-11-28T15:37:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-windsor-protocol-implementation-aspects-t-girard-ema_en.pdf"},
    {"id":"61022","name":"Presentation - Revised Variation Framework (K. Semm, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:40:48Z","last_updated_date":"2023-11-28T15:40:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revised-variation-framework-k-semm-ec_en.pdf"},
    {"id":"61017","name":"Presentation - submission predictability (F. Day, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:23:43Z","last_updated_date":"2023-11-28T15:23:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-submission-predictability-f-day-ema_en.pdf"},
    {"id":"61024","name":"Questions and answers on the withdrawal of application to change the marketing authorisation for Bylvay (odevixibat) ","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2023-11-20T17:21:35Z","last_updated_date":"2023-11-20T17:21:35Z","reference_number":"EMA/492792/2023","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-and-answers-withdrawal-application-change-marketing-authorisation-bylvay-odevixibat_en.pdf"},
    {"id":"61025","name":"Withdrawal assessment report for Bylvay (II-11)","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2023-11-23T17:22:38Z","last_updated_date":"2023-11-23T17:22:38Z","reference_number":"EMA/371338/2023","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-bylvay-ii-11_en.pdf"},
    {"id":"61026","name":"Withdrawal letter: Bylvay (II-11)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T17:24:01Z","last_updated_date":"2023-11-10T17:24:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-bylvay-ii-11_en.pdf-0"},
    {"id":"60609","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 13-15 January 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-01-27T14:09:00Z","last_updated_date":"2020-01-27T14:09:00Z","reference_number":"EMA/HMPC/28633/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-13-15-january-2020_en.pdf"},
    {"id":"59538","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-19 July 2023","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2023-08-02T15:18:00Z","last_updated_date":"2023-08-02T15:18:00Z","reference_number":"EMA/HMPC/338621/2023","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-17-19-july-2023_en.pdf"},
    {"id":"58209","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 13-15 March 2023","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2023-03-29T17:34:00Z","last_updated_date":"2023-03-29T17:34:00Z","reference_number":"EMA/HMPC/125070/2023","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-13-15-march-2023_en.pdf"},
    {"id":"56292","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 19-21 September 2022","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2022-10-03T16:32:00Z","last_updated_date":"2022-10-03T16:32:00Z","reference_number":"EMA/HMPC/782037/20222","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-19-21-september-2022_en.pdf"},
    {"id":"48371","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-07-23T12:04:00Z","last_updated_date":"2020-07-23T12:04:00Z","reference_number":"EMA/HMPC/381575/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-6-8-july-2020_en.pdf"},
    {"id":"54122","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 24-26 January 2022","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2022-02-09T16:43:00Z","last_updated_date":"2022-02-09T16:43:00Z","reference_number":"EMA/HMPC/55879/2022","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-24-26-january-2022_en.pdf"},
    {"id":"54755","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 28-30 March 2022","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2022-04-13T17:02:00Z","last_updated_date":"2022-04-13T17:02:00Z","reference_number":"EMA/HMPC/197395/20222","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-28-30-march-2022_en.pdf"},
    {"id":"48978","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 21-23 September 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-10-09T12:07:00Z","last_updated_date":"2020-10-09T12:07:00Z","reference_number":"EMA/HMPC/512587/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-21-23-september-2020_en.pdf"},
    {"id":"47841","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 4-6 May 2020","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2020-06-03T11:11:00Z","last_updated_date":"2020-06-03T11:11:00Z","reference_number":"EMA/HMPC/257185/2020","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-4-6-may-2020_en.pdf"},
    {"id":"60491","name":"Agenda - Awareness session for SMEs on the reform of the EU pharmaceutical legislation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-10-25T17:40:00Z","last_updated_date":"2023-11-23T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-awareness-session-smes-reform-eu-pharmaceutical-legislation_en.pdf"},
    {"id":"61064","name":"Agenda - seventh ISG meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-11-23T11:27:37Z","last_updated_date":"2023-11-23T11:27:37Z","reference_number":"EMA/511974/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-seventh-isg-meeting_en.pdf"},
    {"id":"48376","name":"CHMP summary of positive opinion for Zynrelef","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-07-24T12:00:00Z","last_updated_date":"2023-11-22T12:00:00Z","reference_number":"EMA/CHMP/367342/2020 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zynrelef_en.pdf"},
    {"id":"61065","name":"Landiolol : List of nationally authorised medicinal products","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-11-27T12:20:47Z","last_updated_date":"2023-11-27T12:20:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/landiolol-list-nationally-authorised-medicinal-products_en.pdf"},
    {"id":"61069","name":"Bicalutamide : List of nationally authorised medicinal products - PSUSA/00000407/202302","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T13:51:58Z","last_updated_date":"2023-11-28T13:51:58Z","reference_number":"EMA/299590/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/bicalutamide-list-nationally-authorised-medicinal-products-psusa-00000407-202302_en.pdf"},
    {"id":"61070","name":"Bosutinib film-coated tablets 100, 400 and 500 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-11-28T14:17:09Z","last_updated_date":"2023-11-28T14:17:09Z","reference_number":"EMA/CHMP/590937/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/bosutinib-film-coated-tablets-100-400-and-500-mg-product-specific-bioequivalence-guidance_en.pdf-0"},
    {"id":"61073","name":"Fampridine prolonged-release tablet 10 mg product specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-11-28T14:49:16Z","last_updated_date":"2023-11-28T14:49:16Z","reference_number":"EMA/CHMP/39346/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/fampridine-prolonged-release-tablet-10-mg-product-specific-bioequivalence-guidance_en.pdf-0"},
    {"id":"61074","name":"Lurasidone film-coated tablets 18.5, 37 and 74 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-11-28T14:56:28Z","last_updated_date":"2023-11-28T14:56:28Z","reference_number":"EMA/CHMP/39336/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lurasidone-film-coated-tablets-185-37-and-74-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"61075","name":"Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T15:04:12Z","last_updated_date":"2023-11-28T15:04:12Z","reference_number":"EMA/CHMP/39336/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/lurasidone-film-coated-tablets-185-37-and-74-mg-4-product-specific-bioequivalence-guidance_en.pdf-0"},
    {"id":"61076","name":"Metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance ","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-11-28T15:13:13Z","last_updated_date":"2023-11-28T15:13:13Z","reference_number":"EMA/CHMP/591346/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/metformin-immediate-release-film-coated-tablets-500-850-and-1000-mg-product-specific-bioequivalence-guidance_en.pdf-0"},
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    {"id":"61181","name":"Methylphenobarbital : List of nationally authorised medicinal products - PSUSA/00002025/202303","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T13:45:55Z","last_updated_date":"2023-12-04T13:45:55Z","reference_number":"EMA/549530/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylphenobarbital-list-nationally-authorised-medicinal-products-psusa-00002025-202303_en.pdf"},
    {"id":"55339","name":"CHMP summary of positive opinion for COVID-19 Vaccine (inactivated, adjuvanted) Valneva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-06-23T16:00:00Z","last_updated_date":"2023-12-01T12:00:00Z","reference_number":"EMEA/H/C/006019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-covid-19-vaccine-inactivated-adjuvanted-valneva_en.pdf"},
    {"id":"61187","name":"Belgium - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T14:45:55Z","last_updated_date":"2023-12-04T14:45:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/belgium-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61188","name":"Public statement on COVID-19 Vaccine (inactivated, adjuvanted) Valneva","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-12-01T14:47:07Z","last_updated_date":"2023-12-01T14:47:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-covid-19-vaccine-inactivated-adjuvanted-valneva_en.pdf"},
    {"id":"61190","name":"Croatia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022​","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T14:50:10Z","last_updated_date":"2023-12-04T14:50:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/croatia-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61189","name":"Bulgaria - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T14:47:53Z","last_updated_date":"2023-12-04T14:47:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/bulgaria-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61191","name":"Cyprus - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T14:54:08Z","last_updated_date":"2023-12-04T14:54:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/cyprus-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61193","name":"​Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T14:58:21Z","last_updated_date":"2023-12-04T14:58:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/czechia-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61194","name":"Denmark - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:00:32Z","last_updated_date":"2023-12-04T15:00:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/denmark-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61195","name":"​Estonia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:04:03Z","last_updated_date":"2023-12-04T15:04:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/estonia-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61196","name":"​Finland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:07:26Z","last_updated_date":"2023-12-04T15:07:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/finland-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf-0"},
    {"id":"61197","name":"France - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:12:36Z","last_updated_date":"2023-12-04T15:12:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/france-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61198","name":"Germany - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:14:42Z","last_updated_date":"2023-12-04T15:14:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/germany-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61199","name":"Greece - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:19:53Z","last_updated_date":"2023-12-04T15:19:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/greece-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61200","name":"Hungary - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:22:39Z","last_updated_date":"2023-12-04T15:22:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/hungary-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61201","name":"Iceland - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:24:21Z","last_updated_date":"2023-12-04T15:24:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/iceland-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61202","name":"Ireland - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:26:35Z","last_updated_date":"2023-12-04T15:26:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ireland-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61203","name":"Italy - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:28:09Z","last_updated_date":"2023-12-04T15:28:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/italy-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61204","name":"Latvia - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:29:30Z","last_updated_date":"2023-12-04T15:29:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/latvia-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61205","name":"Lithuania - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:31:06Z","last_updated_date":"2023-12-04T15:31:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/lithuania-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61206","name":"Luxembourg - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:32:35Z","last_updated_date":"2023-12-04T15:32:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/luxembourg-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61207","name":"Malta - Sales trends (mg/PCU) of antibiotic VMPs for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:34:58Z","last_updated_date":"2023-12-04T15:34:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/malta-sales-trends-mg-pcu-antibiotic-vmps-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61208","name":"Netherlands - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:38:36Z","last_updated_date":"2023-12-04T15:38:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/netherlands-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61209","name":"Norway - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:40:35Z","last_updated_date":"2023-12-04T15:40:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/norway-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61210","name":"Poland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:42:11Z","last_updated_date":"2023-12-04T15:42:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/poland-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61211","name":"Portugal - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:43:36Z","last_updated_date":"2023-12-04T15:43:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/portugal-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61212","name":"Romania - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:55:27Z","last_updated_date":"2023-12-04T15:55:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/romania-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61213","name":"Slovakia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:57:03Z","last_updated_date":"2023-12-04T15:57:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/slovakia-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61214","name":"Slovenia - ​Portugal - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T15:59:48Z","last_updated_date":"2023-12-04T15:59:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/slovenia-portugal-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61215","name":"Spain - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T16:02:37Z","last_updated_date":"2023-12-04T16:02:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/spain-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61216","name":"Sweden - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T16:04:23Z","last_updated_date":"2023-12-04T16:04:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sweden-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61217","name":"​Switzerland - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T16:10:14Z","last_updated_date":"2023-12-04T16:10:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/switzerland-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61218","name":"United Kingdom - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-04T16:12:14Z","last_updated_date":"2023-12-04T16:12:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/united-kingdom-sales-trends-mg-pcu-antibiotic-veterinary-medicinal-products-food-producing-animals-2010-2022_en.pdf"},
    {"id":"61228","name":"Enalapril : List of nationally authorised medicinal products - PSUSA/00001211/202303","type":"psusa","status":"Adopted","consultation_date":"","first_published_date":"2023-12-04T18:42:43Z","last_updated_date":"2023-12-04T18:42:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/enalapril-list-nationally-authorised-medicinal-products-psusa-00001211-202303_en.pdf"},
    {"id":"60994","name":"Overview of comments received on 'Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers' (EMA/CHMP/83033/2023)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2023-11-23T15:44:33Z","last_updated_date":"2023-11-23T15:44:33Z","reference_number":"EMA/251450/2023","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-questions-and-answers-data-requirements-when-transitioning-low-global-warming-potential-lgwp-propellants-oral-pressurised-metered-dose-inhalers-ema-chmp-83033-2023_en.pdf"},
    {"id":"61229","name":"Periodic safety update report single assessments (PSUSAs) - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:06:47Z","last_updated_date":"2023-12-05T09:06:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/periodic-safety-update-report-single-assessments-psusas-download-table-4-december-2023_en.xlsx"},
    {"id":"61234","name":"Paediatric investigation plans - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:23:36Z","last_updated_date":"2023-12-05T09:23:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/paediatric-investigation-plans-download-table-4-december-2023_en.xlsx"},
    {"id":"61235","name":"Rare disease (orphan) designations - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:25:58Z","last_updated_date":"2023-12-05T09:25:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/rare-disease-orphan-designations-download-table-4-december-2023_en.xlsx"},
    {"id":"61230","name":"European public assessment reports (EPARs) for human and veterinary medicines - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:13:05Z","last_updated_date":"2023-12-05T09:13:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/european-public-assessment-reports-epars-human-and-veterinary-medicines-download-table-4-december-2023_en.xlsx"},
    {"id":"61233","name":"Withdrawn applications for human and veterinary medicines - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:19:03Z","last_updated_date":"2023-12-05T09:19:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/withdrawn-applications-human-and-veterinary-medicines-download-table-4-december-2023_en.xlsx"},
    {"id":"61236","name":"Referrals for human and veterinary medicines - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:28:25Z","last_updated_date":"2023-12-05T09:28:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/referrals-human-and-veterinary-medicines-download-table-4-december-2023_en.xlsx"},
    {"id":"61237","name":"Medicine shortages - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:31:08Z","last_updated_date":"2023-12-05T09:31:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/medicine-shortages-download-table-4-december-2023_en.xlsx"},
    {"id":"61238","name":"Herbal medicines - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:33:22Z","last_updated_date":"2023-12-05T09:33:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/herbal-medicines-download-table-4-december-2023_en.xlsx"},
    {"id":"61239","name":"Medicines for use outside the European Union - Download table of 4 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T09:35:08Z","last_updated_date":"2023-12-05T09:35:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/medicines-use-outside-european-union-download-table-4-december-2023_en.xlsx"},
    {"id":"61219","name":"COVID-19 lessons learned - Joint report on the response to the public health emergency","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-12-01T14:00:00Z","last_updated_date":"2023-12-01T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/covid-19-lessons-learned-joint-report-response-public-health-emergency_en.pdf"},
    {"id":"61253","name":"CTIS newsflash – 24 November 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T15:25:51Z","last_updated_date":"2023-12-05T15:25:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-24-november-2023_en.pdf"},
    {"id":"61254","name":"Structured guidance on the use of extrapolation","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2022-04-04T15:32:54Z","last_updated_date":"2022-04-04T15:32:54Z","reference_number":"EMA/CHMP/13622/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/structured-guidance-use-extrapolation_en.pdf"},
    {"id":"61257","name":"Agenda of the Medicine Shortages (SPOC) Working Party 20 November 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-12-05T16:15:34Z","last_updated_date":"2023-12-05T16:15:34Z","reference_number":"EMA/549634/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-20-november-2023_en.pdf"},
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    {"id":"61266","name":"Presentation - The EU EU health policy Pharmaceutical  Reform - Lilia Luchianov (DG SANTE, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-06T11:02:06Z","last_updated_date":"2023-12-06T11:02:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-eu-health-policy-pharmaceutical-reform-lilia-luchianov-dg-sante-ec_en.pdf"},
    {"id":"61288","name":"Info cards antimicrobial resistance","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-11-11T17:25:12Z","last_updated_date":"2022-11-11T17:25:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/info-cards-antimicrobial-resistance_en.pdf"},
    {"id":"61291","name":"Rifamycin : List of nationally authorised medicinal products - PSUSA/00002641/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T10:07:51Z","last_updated_date":"2023-12-07T10:07:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/rifamycin-list-nationally-authorised-medicinal-products-psusa-00002641-202304_en.pdf"},
    {"id":"61293","name":"Ofloxacin (systemic use) : List of nationally authorised medicinal products - PSUSA/00002203/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T12:31:28Z","last_updated_date":"2023-12-07T12:31:28Z","reference_number":"EMA/348805/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/ofloxacin-systemic-use-list-nationally-authorised-medicinal-products-psusa-00002203-202304_en.pdf"},
    {"id":"61297","name":"Presentation - Strengthening the regulatory/HTA interface: Update on the support to the HTA Regulation implementation - M. Berntgen, F. Cerreta (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T13:59:19Z","last_updated_date":"2023-12-07T13:59:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-regulatory-hta-interface-update-support-hta-regulation-implementation-m-berntgen-f-cerreta-ema_en.pdf"},
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    {"id":"61301","name":"Presentation - ECHA proposal to ban PFAS – potential impact on availability of medicines - M. Alcaraz (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T14:13:45Z","last_updated_date":"2023-12-07T14:13:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-echa-proposal-ban-pfas-potential-impact-availability-medicines-m-alcaraz-ema_en.pdf"},
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    {"id":"61304","name":"Presentation - Skills Training for Young Patient Advocates (STYPA) 2023 - C. Louati (EPF)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T14:21:35Z","last_updated_date":"2023-12-07T14:21:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-skills-training-young-patient-advocates-stypa-2023-c-louati-epf_en.pdf"},
    {"id":"61305","name":"Presentation - Next-generation health guidelines - I. Agache (EAACI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T14:24:03Z","last_updated_date":"2023-12-07T14:24:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-next-generation-health-guidelines-i-agache-eaaci_en.pdf"},
    {"id":"61296","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 20-22 November 2023","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T13:06:52Z","last_updated_date":"2023-12-07T13:06:52Z","reference_number":"EMA/HMPC/535681/2023","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-and-other-activities-20-22-november-2023_en.pdf"},
    {"id":"61306","name":"Presentation - Highlights 2023 - I. Silva, M. Mavris (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:16:52Z","last_updated_date":"2023-12-07T15:16:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-highlights-2023-i-silva-m-mavris-ema_en.pdf"},
    {"id":"61307","name":"Presentation - COMP Feedback - M. Cavaller, E. Rook, T. Leest","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:19:17Z","last_updated_date":"2023-12-07T15:19:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comp-feedback-m-cavaller-e-rook-t-leest_en.pdf"},
    {"id":"61308","name":"Presentation - Patient Experience Data pilot project – M. Cavaller","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:21:44Z","last_updated_date":"2023-12-07T15:21:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-pilot-project-m-cavaller_en.pdf"},
    {"id":"61309","name":"Presentation - Highlights on the Committee for Advanced Therapies - M. de Lemus","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:23:58Z","last_updated_date":"2023-12-07T15:23:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-highlights-committee-advanced-therapies-m-de-lemus_en.pdf"},
    {"id":"61310","name":"Presentation - CHMP feedback - C. Prieto, F. Ventura","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:27:08Z","last_updated_date":"2023-12-07T15:27:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmp-feedback-c-prieto-f-ventura_en.pdf"},
    {"id":"61311","name":"Presentation - PDCO update - J. Taminiau","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:29:07Z","last_updated_date":"2023-12-07T15:29:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-update-j-taminiau_en.pdf"},
    {"id":"61313","name":"Presentation - Update on Patient Experience Data - R. Gonzalez-Quevedo (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:30:40Z","last_updated_date":"2023-12-07T15:30:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-patient-experience-data-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"61314","name":"Presentation - Big Data Steering Group Workplan - D. Umuhire (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:33:12Z","last_updated_date":"2023-12-07T15:33:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-steering-group-workplan-d-umuhire-ema_en.pdf"},
    {"id":"61315","name":"Presentation - DARWIN EU - A. Segec (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:34:56Z","last_updated_date":"2023-12-07T15:34:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-darwin-eu-segec-ema_en.pdf"},
    {"id":"61316","name":"Presentation - Delivering on stakeholders’ requirements for AI - L. Pinheiro (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:36:34Z","last_updated_date":"2023-12-07T15:36:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-delivering-stakeholders-requirements-ai-l-pinheiro-ema_en.pdf"},
    {"id":"61317","name":"Presentation - Facilitating innovation in regulatory science: research needs and multi-stakeholder collaboration - R. Herold (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:39:43Z","last_updated_date":"2023-12-07T15:39:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-facilitating-innovation-regulatory-science-research-needs-and-multi-stakeholder-collaboration-r-herold-ema_en.pdf"},
    {"id":"61318","name":"Presentation - Improving understanding of biosimilars: Toolkit for Member States - B. Duggan (HMA), R. Gonzalez-Quevedo (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-07T15:42:31Z","last_updated_date":"2023-12-07T15:42:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-improving-understanding-biosimilars-toolkit-member-states-b-duggan-hma-r-gonzalez-quevedo-ema_en.pdf"},
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    {"id":"45467","name":"CHMP summary of positive opinion for Ivozall","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2019-09-20T16:22:00Z","last_updated_date":"2023-12-07T15:52:00Z","reference_number":"EMA/CHMP/494372/2019","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ivozall_en.pdf"},
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    {"id":"57081","name":"Reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs","type":"scientific-guideline","status":"Adopted","consultation_date":"2022-12-16 - 2023-03-31","first_published_date":"2022-12-16T13:59:00Z","last_updated_date":"2023-11-21T11:11:11Z","reference_number":"EMA/CVMP/ERA/31905/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-environmental-risk-assessment-ectoparasiticidal-veterinary-medicinal-products-used-cats-and-dogs_en.pdf"},
    {"id":"61342","name":"Draft reflection paper on the environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs","type":"scientific-guideline","status":"unknown","consultation_date":"2022-12-16 - 2023-03-31","first_published_date":"2022-12-16T16:03:33Z","last_updated_date":"2022-12-16T16:03:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-environmental-risk-assessment-ectoparasiticidal-veterinary-medicinal-products-used-cats-and-dogs_en.pdf"},
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    {"id":"61349","name":"Presentation - Progress update and report at EU-level - EMA/HMA Big Data Steering Group - J. Kjaer","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T14:18:57Z","last_updated_date":"2023-12-11T14:18:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-progress-update-and-report-eu-level-ema-hma-big-data-steering-group-j-kjaer_en.pdf"},
    {"id":"61350","name":"Presentation - AI / ML initiatives that were developed and are applied at Swissmedic - M. Renaudin","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T14:23:22Z","last_updated_date":"2023-12-11T14:23:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ai-ml-initiatives-were-developed-and-are-applied-swissmedic-m-renaudin_en.pdf"},
    {"id":"61351","name":"Presentation - Big data to support innovation and regulatory decision making - C. Stirling","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T14:26:03Z","last_updated_date":"2023-12-11T14:26:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-support-innovation-and-regulatory-decision-making-c-stirling_en.pdf"},
    {"id":"61352","name":"Presentation - Big Data in Veterinary Medicines Regulation - J. Verstegen","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T14:27:52Z","last_updated_date":"2023-12-11T14:27:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-veterinary-medicines-regulation-j-verstegen_en.pdf"},
    {"id":"61353","name":"Presentation - Cross-agency cooperation view - environmental and veterinary big data for One Health collaboration - D. Piselli","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T14:30:00Z","last_updated_date":"2023-12-11T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cross-agency-cooperation-view-environmental-and-veterinary-big-data-one-health-collaboration-d-piselli_en.pdf"},
    {"id":"61354","name":"Presentation - Veterinary Big Data Work Plan 2022-2025 - S. Bertulat","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T14:32:39Z","last_updated_date":"2023-12-11T14:32:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-big-data-work-plan-2022-2025-s-bertulat_en.pdf"},
    {"id":"60920","name":"Agenda – System Demo Q4 2023 - 19 December 2023","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-11-20T13:14:52Z","last_updated_date":"2023-12-11T15:00:00Z","reference_number":"EMA/448909/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-system-demo-q4-2023-19-december-2023_en.pdf"},
    {"id":"19524","name":"Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T11:12:01Z","last_updated_date":"2023-12-11T16:48:00Z","reference_number":"EMA/364980/2017_rev. 2","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/quick-response-qr-codes-labelling-and-or-package-leaflet-veterinary-medicinal-products-authorised-centralised-cp-mutual-recognition-mrp-decentralised-procedures-dcp-and-national-procedures_en.pdf"},
    {"id":"31546","name":"Request form for the provision of information via Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentra...","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2018-02-09T11:10:00Z","last_updated_date":"2023-12-11T16:50:00Z","reference_number":"EMA/818103/2017, rev. 1","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-form-provision-information-quick-response-qr-codes-labelling-and-or-package-leaflet-veterinary-medicinal-products-authorised-centralised-cp-mutual-recognition-mrp-decentra_en.pdf"},
    {"id":"25755","name":"Reflection paper on ethical and good-clinical-practice aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU) / European Economic Area and submitted in marketing-autho...","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-04-16T19:16:00Z","last_updated_date":"2012-04-16T19:16:00Z","reference_number":"EMA/121340/2011","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-ethical-and-good-clinical-practice-aspects-clinical-trials-medicinal-products-human-use-conducted-outside-european-union-eu-european-economic-area-and-submitted-marketing-autho_en.pdf"},
    {"id":"59690","name":"Vaccine Monitoring Platform (VMP) research agenda","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-09-27T18:36:44Z","last_updated_date":"2023-09-27T18:36:44Z","reference_number":"EMA/430310/2023","document_url":"https://www.ema.europa.eu/en/documents/other/vaccine-monitoring-platform-vmp-research-agenda_en.pdf"},
    {"id":"56357","name":"Data Quality Framework for EU medicines regulation","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"2022-10-10 - 2022-11-18","first_published_date":"2022-10-10T17:00:00Z","last_updated_date":"2023-12-12T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf"},
    {"id":"61368","name":"Questions and answers on the Union list of critical medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T11:44:18Z","last_updated_date":"2023-12-12T11:44:18Z","reference_number":"EMA/438798/2023","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-union-list-critical-medicines_en.pdf"},
    {"id":"61367","name":"Methodology to identify critical medicines for the “Union  List of critical medicines”","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T11:42:33Z","last_updated_date":"2023-12-12T11:42:33Z","reference_number":"EMA/432940/2023","document_url":"https://www.ema.europa.eu/en/documents/other/methodology-identify-critical-medicines-union-list-critical-medicines_en.pdf"},
    {"id":"61373","name":"Presentation - Session 2: Veterinary medicinal products specificities and challenges","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T11:59:37Z","last_updated_date":"2023-12-12T11:59:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-veterinary-medicinal-products-specificities-and-challenges_en.pdf"},
    {"id":"61374","name":"Presentation - Session 3: Engagement with Stakeholders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:00:55Z","last_updated_date":"2023-12-12T12:00:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-engagement-stakeholders_en.pdf"},
    {"id":"61375","name":"Presentation - Session 4.1: Engagement with Academia ","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:01:43Z","last_updated_date":"2023-12-12T12:01:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-41-engagement-academia_en.pdf"},
    {"id":"61376","name":"Presentation - Session 4.2: Programmes catered to academic developers PRIME, Orphan drugs, Paediatric drugs, Advanced Therapies, Repurposing ","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:02:41Z","last_updated_date":"2023-12-12T12:02:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-42-programmes-catered-academic-developers-prime-orphan-drugs-paediatric-drugs-advanced-therapies-repurposing_en.pdf"},
    {"id":"61377","name":"Presentation - Session 4.3: Innovation in medicines","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:03:40Z","last_updated_date":"2023-12-12T12:03:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-43-innovation-medicines_en.pdf"},
    {"id":"61379","name":"Presentation - Session 5.2: EMA career opportunities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:05:42Z","last_updated_date":"2023-12-12T12:05:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-52-ema-career-opportunities_en.pdf"},
    {"id":"61381","name":"Minutes - DARWIN EU Advisory Board meeting: 6 February 2023","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:27:39Z","last_updated_date":"2023-12-12T12:27:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-darwin-eu-advisory-board-meeting-6-february-2023_en.pdf"},
    {"id":"61385","name":"Agenda - Eleventh industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T15:38:17Z","last_updated_date":"2023-12-12T15:38:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eleventh-industry-stakeholder-platform-research-and-development-support_en.pdf"},
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    {"id":"46554","name":"Record of data processing activity for pre-employment medical examination","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-01-24T14:20:00Z","last_updated_date":"2023-12-12T16:00:00Z","reference_number":"EMA/684623/2019","document_url":"https://www.ema.europa.eu/en/documents/other/record-data-processing-activity-pre-employment-medical-examination_en.pdf"},
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    {"id":"61400","name":"Presentation - Update from Enpr-EMA off-label working group (S. de Wildt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-13T14:48:58Z","last_updated_date":"2023-12-13T14:48:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-enpr-ema-label-working-group-s-de-wildt_en.pdf"},
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    {"id":"61420","name":"Human medicines highlights - November-December 2023","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2023-12-14T14:32:46Z","last_updated_date":"2023-12-14T14:32:46Z","reference_number":"Issue 175","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-november-december-2023_en.pdf"},
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    {"id":"61396","name":"Agenda of the 122nd meeting of the Management Board, 13-14 December 2023","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2023-12-13T11:48:36Z","last_updated_date":"2023-12-15T09:22:00Z","reference_number":"EMA/MB/490304/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-122nd-meeting-management-board-13-14-december-2023_en.pdf"},
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    {"id":"61431","name":"CHMP post-authorisation summary of positive opinion for HyQvia (II-87)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2023-12-15T12:00:00Z","last_updated_date":"2023-12-15T12:00:00Z","reference_number":"EMA/516097/2023","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-hyqvia-ii-87_en.pdf"},
    {"id":"61432","name":"CHMP initial authorisation summary of positive opinion for Dabigatran Etexilate Leon Farma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-12-15T12:00:00Z","last_updated_date":"2023-12-15T12:00:00Z","reference_number":"EMA/CHMP/556286/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-initial-authorisation-summary-positive-opinion-dabigatran-etexilate-leon-farma_en.pdf"},
    {"id":"61433","name":"CHMP initial authorisation summary of positive opinion for Ibuprofen Gen.Orph","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-12-15T12:00:00Z","last_updated_date":"2023-12-15T12:00:00Z","reference_number":"EMA/CHMP/562650/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-initial-authorisation-summary-positive-opinion-ibuprofen-genorph_en.pdf"},
    {"id":"61426","name":"CHMP summary of positive opinion for Velsipity","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-12-15T12:00:00Z","last_updated_date":"2023-12-15T12:00:00Z","reference_number":"EMA/CHMP/552342/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-velsipity_en.pdf"},
    {"id":"61424","name":"CHMP summary of positive opinion for Pomalidomide Viatris","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:57:22Z","last_updated_date":"2023-12-15T15:57:22Z","reference_number":"EMA/CHMP/554066/2023","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pomalidomide-viatris_en.pdf"},
    {"id":"61439","name":"CHMP post-authorisation summary of positive opinion for Fexinidazole Winthrop  (II-16)","type":"outside-EU-smop","status":"Adopted","consultation_date":"","first_published_date":"2023-12-15T13:24:16Z","last_updated_date":"2023-12-15T13:24:16Z","reference_number":"EMA/CHMP/559550/2023","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-smop/chmp-post-authorisation-summary-positive-opinion-fexinidazole-winthrop-ii-16_en.pdf"},
    {"id":"61427","name":"CHMP summary of positive opinion for Mevlyq","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2023-12-15T12:00:00Z","last_updated_date":"2023-12-15T12:00:00Z","reference_number":"EMA/CHMP/543409/2023 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-mevlyq_en.pdf"},
    {"id":"61443","name":"Overview of comments received on draft ‘Guideline on the  acceptability of names for human medicinal products  processed through the centralised procedure’","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T14:23:29Z","last_updated_date":"2023-12-15T14:23:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/overview-comments-received-draft-guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure_en.pdf"},
    {"id":"41851","name":"Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-07-25T14:15:00Z","last_updated_date":"2023-12-15T15:00:00Z","reference_number":"EMA/CVMP/150343/2016-Rev.4","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-describing-adverse-events-product-information-summary-product-characteristics-spc-and-package-leaflet-pl_en.pdf"},
    {"id":"61446","name":"Presentation - Complex clinical trials, enabling innovative designs (breakout session A), EFSPI perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:25:38Z","last_updated_date":"2023-12-15T15:25:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-enabling-innovative-designs-breakout-session-efspi-perspective_en.pdf"},
    {"id":"61447","name":"Presentation - Paediatric clinical trials - Ethics perspective (breakout session B)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:26:50Z","last_updated_date":"2023-12-15T15:26:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-clinical-trials-ethics-perspective-breakout-session-b_en.pdf"},
    {"id":"61448","name":"Presentation - Paediatric clinical trials - Industry perspective (breakout session B)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:28:04Z","last_updated_date":"2023-12-15T15:28:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-clinical-trials-industry-perspective-breakout-session-b_en.pdf"},
    {"id":"60425","name":"Draft guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD)","type":"scientific-guideline","status":"Draft","consultation_date":"2023-10-13 - 2023-11-13","first_published_date":"2023-10-13T11:00:00Z","last_updated_date":"2023-10-13T11:00:00Z","reference_number":"EMA/CVMP/PhVWPV/399363/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-calculation-dose-factor-be-submitted-union-product-database-upd_en.pdf"},
    {"id":"61451","name":"Presentation - Paediatric clinical trials - Regulatory perspective (breakout session B)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:30:47Z","last_updated_date":"2023-12-15T15:30:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-clinical-trials-regulatory-perspective-breakout-session-b_en.pdf"},
    {"id":"61452","name":"Presentation - Paediatric clinical trials - Setting the scene (breakout session B)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:31:27Z","last_updated_date":"2023-12-15T15:31:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-clinical-trials-setting-scene-breakout-session-b_en.pdf"},
    {"id":"61453","name":"Presentation - Validation of digital endpoints - Academic perspective (breakout session D)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:32:11Z","last_updated_date":"2023-12-15T15:32:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-validation-digital-endpoints-academic-perspective-breakout-session-d_en.pdf"},
    {"id":"61454","name":"\tPresentation - Validation of digital endpoints - Industry perspective (breakout session D)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:33:31Z","last_updated_date":"2023-12-15T15:33:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-validation-digital-endpoints-industry-perspective-breakout-session-d_en.pdf"},
    {"id":"61455","name":"Presentation - Beyond Randomised Clinical Trials - Academic perspective (breakout session E)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:34:04Z","last_updated_date":"2023-12-15T15:34:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-beyond-randomised-clinical-trials-academic-perspective-breakout-session-e_en.pdf"},
    {"id":"61456","name":"Presentation - Beyond Randomised Clinical Trials - Ethical perspective (breakout session E)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:34:52Z","last_updated_date":"2023-12-15T15:34:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-beyond-randomised-clinical-trials-ethical-perspective-breakout-session-e_en.pdf"},
    {"id":"61457","name":"Presentation - Beyond Randomised Clinical Trials - HTA perspective (breakout session E)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:35:20Z","last_updated_date":"2023-12-15T15:35:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-beyond-randomised-clinical-trials-hta-perspective-breakout-session-e_en.pdf"},
    {"id":"61458","name":"Presentation - Beyond Randomised Clinical Trials - Industry perspective (breakout session E)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:35:53Z","last_updated_date":"2023-12-15T15:35:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-beyond-randomised-clinical-trials-industry-perspective-breakout-session-e_en.pdf"},
    {"id":"61459","name":"Presentation - Patient centricity, inclusion and representativeness in clinical trials - Ethical and academic perspective (breakout session F)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:36:43Z","last_updated_date":"2023-12-15T15:36:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-centricity-inclusion-and-representativeness-clinical-trials-ethical-and-academic-perspective-breakout-session-f_en.pdf"},
    {"id":"61460","name":"Presentation - Patient centricity, inclusion and representativeness in clinical trials - Industry perspective (breakout session F)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:37:37Z","last_updated_date":"2023-12-15T15:37:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-centricity-inclusion-and-representativeness-clinical-trials-industry-perspective-breakout-session-f_en.pdf"},
    {"id":"61461","name":"Presentation - Patient centricity, inclusion and representativeness in clinical trials - Patients perspective (breakout session F)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:38:05Z","last_updated_date":"2023-12-15T15:38:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-centricity-inclusion-and-representativeness-clinical-trials-patients-perspective-breakout-session-f_en.pdf"},
    {"id":"61462","name":"Presentation - Patient centricity, inclusion and representativeness in clinical trials - Setting the scene (breakout session F)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:38:33Z","last_updated_date":"2023-12-15T15:38:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-centricity-inclusion-and-representativeness-clinical-trials-setting-scene-breakout-session-f_en.pdf"},
    {"id":"61463","name":"Presentation - Decentralised clinical trials - Data analysis perspective (breakout session G)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:39:10Z","last_updated_date":"2023-12-15T15:39:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-decentralised-clinical-trials-data-analysis-perspective-breakout-session-g_en.pdf"},
    {"id":"61464","name":"Presentation - Decentralised clinical trials - Industry perspective (breakout session G)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:40:06Z","last_updated_date":"2023-12-15T15:40:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-decentralised-clinical-trials-industry-perspective-breakout-session-g_en.pdf"},
    {"id":"61465","name":"Presentation - Decentralised clinical trials - Patients perspective (breakout session G)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:40:37Z","last_updated_date":"2023-12-15T15:40:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-decentralised-clinical-trials-patients-perspective-breakout-session-g_en.pdf"},
    {"id":"61466","name":"Presentation - Complex clinical trials - Academic perspective (breakout session H)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:41:08Z","last_updated_date":"2023-12-15T15:41:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-academic-perspective-breakout-session-h_en.pdf"},
    {"id":"61467","name":"Presentation - Complex clinical trials - HTA perspective (breakout session H)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:41:55Z","last_updated_date":"2023-12-15T15:41:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-hta-perspective-breakout-session-h_en.pdf"},
    {"id":"61468","name":"Presentation - Complex clinical trials - Setting the scene (breakout session H)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T15:42:18Z","last_updated_date":"2023-12-15T15:42:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-setting-scene-breakout-session-h_en.pdf"},
    {"id":"61470","name":"Report - EMA multi-stakeholder workshop on qualification of novel methodologies","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-12-15T16:13:16Z","last_updated_date":"2023-12-15T16:13:16Z","reference_number":"EMA/569008/2023","document_url":"https://www.ema.europa.eu/en/documents/report/report-ema-multi-stakeholder-workshop-qualification-novel-methodologies_en.pdf"},
    {"id":"58745","name":"Introduction - EMA multi-stakeholder workshop on qualification of novel methodologies","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-05-24T09:52:00Z","last_updated_date":"2023-05-24T09:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/introduction-ema-multi-stakeholder-workshop-qualification-novel-methodologies_en.pdf"},
    {"id":"61479","name":"Draft Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications","type":"scientific-guideline","status":"unknown","consultation_date":"2023-12-15 - 2024-03-04","first_published_date":"2023-12-18T10:54:26Z","last_updated_date":"2023-12-18T10:54:26Z","reference_number":"EMA/CHMP/566497/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-assessment-smpc-section-51-guide-assessors-centralised-applications_en.pdf"},
    {"id":"61485","name":"Reflection paper on regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-12-18T14:44:45Z","last_updated_date":"2023-12-18T14:44:45Z","reference_number":"EMA/CHMP/536854/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-requirements-development-medicinal-products-acute-kidney-injury-aki_en.pdf"},
    {"id":"61488","name":"Overview of comments received on Guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD) (EMA/CVMP/PhVWPV/399363/2023)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2023-12-18T16:09:42Z","last_updated_date":"2023-12-18T16:09:42Z","reference_number":"EMA/CVMP/PhVWPV/470818/2023","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-calculation-dose-factor-be-submitted-union-product-database-upd-ema-cvmp-phvwpv-399363-2023_en.pdf"},
    {"id":"61175","name":"Direct healthcare professional communication (DHPC): Integrilin (eptifibatide): Discontinuation of manufacturing of Integrilin","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-12-01T12:00:00Z","last_updated_date":"2023-12-01T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-integrilin-eptifibatide-discontinuation-manufacturing-integrilin_en.pdf"},
    {"id":"61490","name":"Questions and Answers - Union Product Database - Product grouping and third country product names Webinar for Industry users","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-18T17:28:17Z","last_updated_date":"2023-12-18T17:28:17Z","reference_number":"EMA/483124/2023","document_url":"https://www.ema.europa.eu/en/documents/other/questions-and-answers-union-product-database-product-grouping-and-third-country-product-names-webinar-industry-users_en.pdf"},
    {"id":"32307","name":"Notification of discontinuation of an agreed PIP decision","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2013-04-02T11:09:00Z","last_updated_date":"2023-12-19T11:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/notification-discontinuation-agreed-pip-decision_en.doc"},
    {"id":"61174","name":"Direct healthcare professional communication (DHPC): Omega-3-acid ethyl ester medicines: dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2023-12-01T12:00:00Z","last_updated_date":"2023-12-01T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-omega-3-acid-ethyl-ester-medicines-dose-dependent-increased-risk-atrial-fibrillation-patients-established-cardiovascular-diseases-or-cardiovascular_en.pdf"},
    {"id":"61355","name":"EMA–FDA joint Q&As on Quality and GMP aspects of  PRIME/Breakthrough therapy applications","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T14:00:00Z","last_updated_date":"2023-12-19T14:00:00Z","reference_number":"EMA/CHMP/531552/2023","document_url":"https://www.ema.europa.eu/en/documents/other/ema-fda-joint-qas-quality-and-gmp-aspects-prime-breakthrough-therapy-applications_en.pdf"},
    {"id":"61499","name":"Request a change of the applicant for an ongoing marketing authorisation application","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T14:48:33Z","last_updated_date":"2023-12-19T14:48:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/request-change-applicant-ongoing-marketing-authorisation-application_en.pdf"},
    {"id":"61500","name":"Presentation - National regulatory supports for Innovation (Larry O’Dwyer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T14:54:55Z","last_updated_date":"2023-12-19T14:54:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-national-regulatory-supports-innovation-larry-odwyer_en.pdf"},
    {"id":"61502","name":"Presentation - EMA support to innovative developers (Oriane Blanquie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T14:58:45Z","last_updated_date":"2023-12-19T14:58:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-support-innovative-developers-oriane-blanquie_en.pdf"},
    {"id":"61503","name":"Presentation - Strengthening life sciences innovation across Europe (Dr. Deana Mohr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:00:24Z","last_updated_date":"2023-12-19T15:00:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-life-sciences-innovation-across-europe-dr-deana-mohr_en.pdf"},
    {"id":"61504","name":"Presentation - Strengthening life sciences innovation across Europe (Paul Sarret)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:04:54Z","last_updated_date":"2023-12-19T15:04:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strengthening-life-sciences-innovation-across-europe-paul-sarret_en.pdf"},
    {"id":"61509","name":"Presentation - Eurasante (Dorothee Gueras)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:11:44Z","last_updated_date":"2023-12-19T15:11:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eurasante-dorothee-gueras_en.pdf"},
    {"id":"61510","name":"Presentation - Translating discovery into innovation (Lourdes Núñez Müller)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:17:58Z","last_updated_date":"2023-12-19T15:17:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-translating-discovery-innovation-lourdes-nunez-muller_en.pdf"},
    {"id":"61511","name":"Presentation - Biocatalyst foundation (Andrii Shekhirev)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:31:58Z","last_updated_date":"2023-12-19T15:31:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-biocatalyst-foundation-andrii-shekhirev_en.pdf"},
    {"id":"61512","name":"Presentation - Successfully scaling in Europe (Menno Kok)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:35:05Z","last_updated_date":"2023-12-19T15:35:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-successfully-scaling-europe-menno-kok_en.pdf"},
    {"id":"61513","name":"Presentation - Bio 4 dreams (Luigi Azzarone)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:39:28Z","last_updated_date":"2023-12-19T15:39:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bio-4-dreams-luigi-azzarone_en.pdf"},
    {"id":"61514","name":"Presentation - Flanders irf, connecting the ecosystem dots (Dominic De Groote)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T15:41:07Z","last_updated_date":"2023-12-19T15:41:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-flanders-irf-connecting-ecosystem-dots-dominic-de-groote_en.pdf"},
    {"id":"61449","name":"Guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD)","type":"scientific-guideline","status":"Adopted","consultation_date":"2023-10-13 - 2023-11-13","first_published_date":"2023-12-15T15:28:17Z","last_updated_date":"2023-12-15T15:28:17Z","reference_number":"EMA/CVMP/PhVWPV/399363/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-calculation-dose-factor-be-submitted-union-product-database-upd_en.pdf"},
    {"id":"61522","name":"Presentation - Update on AI in pharmacovigilance at EMA (J. Durand, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T16:13:53Z","last_updated_date":"2023-12-19T16:13:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ai-pharmacovigilance-ema-j-durand-ema_en.pdf"},
    {"id":"61523","name":"Presentation - Update on Good Pharmacovigilance Practices (EU-GVP) (P. Bahri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T16:21:14Z","last_updated_date":"2023-12-19T16:21:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-good-pharmacovigilance-practices-eu-gvp-p-bahri-ema_en.pdf"},
    {"id":"61524","name":"Presentation - RMP publication and Specific adverse reaction Follow-up questionnaires guideline (E. Cochino, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T16:23:40Z","last_updated_date":"2023-12-19T16:23:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rmp-publication-and-specific-adverse-reaction-follow-questionnaires-guideline-e-cochino-ema_en.pdf"},
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    {"id":"55516","name":"Minutes - DARWIN EU Advisory Board meeting: 20 April 2022","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2022-07-12T11:41:00Z","last_updated_date":"2022-07-12T11:41:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-darwin-eu-advisory-board-meeting-20-april-2022_en.pdf"},
    {"id":"42940","name":"PDCO monthly report of opinions on paediatric investigation plans and other activities 13-16 November 2018","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2018-12-05T18:01:00Z","last_updated_date":"2018-12-05T18:01:00Z","reference_number":"EMEA/PDCO/820568/2018","document_url":"https://www.ema.europa.eu/en/documents/committee-report/pdco-monthly-report-opinions-paediatric-investigation-plans-and-other-activities-13-16-november-2018_en.pdf"},
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    {"id":"48124","name":"Emer Cooke nominated as new EMA Executive Director","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-06-25T13:48:00Z","last_updated_date":"2020-06-25T13:48:00Z","reference_number":"EMA/343786/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/emer-cooke-nominated-new-ema-executive-director_en.pdf"},
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    {"id":"61637","name":"Product Lifecycle Management Value Stream Deep-Dive Webinar (30 November 2023) – Questions & Answers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T10:12:24Z","last_updated_date":"2024-01-05T10:12:24Z","reference_number":"EMA/821/2024","document_url":"https://www.ema.europa.eu/en/documents/other/product-lifecycle-management-value-stream-deep-dive-webinar-30-november-2023-questions-answers_en.pdf"},
    {"id":"61639","name":"Addendum to assessment report on Prunus africana (Hook f.) Kalkm., cortex","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T13:48:34Z","last_updated_date":"2024-01-05T13:48:34Z","reference_number":"EMA/HMPC/321020/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-prunus-africana-hook-f-kalkm-cortex_en.pdf"},
    {"id":"61640","name":"Addendum to assessment report on Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. & Heldr.; Sideritis syriaca L., herba","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T13:55:56Z","last_updated_date":"2024-01-05T13:55:56Z","reference_number":"EMA/HMPC/320997/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-sideritis-scardica-griseb-sideritis-clandestina-bory-chaub-hayek-sideritis-raeseri-boiss-heldr-sideritis-syriaca-l-herba_en.pdf"},
    {"id":"61641","name":"Addendum to assessment report on Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill., flos","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T14:05:03Z","last_updated_date":"2024-01-05T14:05:03Z","reference_number":"EMA/HMPC/320996/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-rosa-centifolia-l-rosa-gallica-l-rosa-damascena-mill-flos_en.pdf"},
    {"id":"56976","name":"Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary training courses - February, May and July 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-12-15T13:15:00Z","last_updated_date":"2022-12-15T13:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/programme-and-registration-form-extended-eudravigilance-medicinal-product-dictionary-training-courses-february-may-and-july-2023_en.pdf"},
    {"id":"61642","name":"eXtended EudraVigilance Medicinal Product Dictionary training course - February, April and June 2024","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T14:37:58Z","last_updated_date":"2024-01-05T14:37:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/extended-eudravigilance-medicinal-product-dictionary-training-course-february-april-and-june-2024_en.pdf"},
    {"id":"61644","name":"Presentation - Complex clinical trials - Enabling innovative designs - Patients' journey studies (breakout session A)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T16:45:53Z","last_updated_date":"2024-01-05T16:45:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-enabling-innovative-designs-patients-journey-studies-breakout-session_en.pdf"},
    {"id":"61645","name":"\tPresentation - Complex clinical trials - Enabling innovative designs - Setting the scene (breakout session A)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T16:51:34Z","last_updated_date":"2024-01-05T16:51:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-enabling-innovative-designs-setting-scene-breakout-session_en.pdf"},
    {"id":"61646","name":"\tPresentation - Complex clinical trials - Enabling innovative designs - The experience of the DRUP trial (breakout session A)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T16:53:14Z","last_updated_date":"2024-01-05T16:53:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-enabling-innovative-designs-experience-drup-trial-breakout-session_en.pdf"},
    {"id":"61650","name":"\tPresentation - Pragmatic trials, definition and usefulness - Academic perspective (EORTC) Complex clinical trials - Enabling innovative designs - Industry perspective (breakout session C)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T17:01:07Z","last_updated_date":"2024-01-05T17:01:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pragmatic-trials-definition-and-usefulness-academic-perspective-eortc-complex-clinical-trials-enabling-innovative-designs-industry-perspective-breakout-session-c_en.pdf"},
    {"id":"61647","name":"Presentation - Pragmatic trials, definition and usefulness - Academic perspective (EORTC) Complex clinical trials - Enabling innovative designs - Patients' journey studies (breakout session C)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T16:54:50Z","last_updated_date":"2024-01-05T16:54:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pragmatic-trials-definition-and-usefulness-academic-perspective-eortc-complex-clinical-trials-enabling-innovative-designs-patients-journey-studies-breakout-session-c_en.pdf"},
    {"id":"61648","name":"Presentation - Pragmatic trials, definition and usefulness - Academic perspective (EORTC) Complex clinical trials - Enabling innovative designs - Ethical perspective (breakout session C)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T16:58:53Z","last_updated_date":"2024-01-05T16:58:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pragmatic-trials-definition-and-usefulness-academic-perspective-eortc-complex-clinical-trials-enabling-innovative-designs-ethical-perspective-breakout-session-c_en.pdf"},
    {"id":"61649","name":"\tPresentation - Pragmatic trials, definition and usefulness - Academic perspective (EORTC) Complex clinical trials - Enabling innovative designs - HTA perspective (breakout session C)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T17:00:04Z","last_updated_date":"2024-01-05T17:00:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pragmatic-trials-definition-and-usefulness-academic-perspective-eortc-complex-clinical-trials-enabling-innovative-designs-hta-perspective-breakout-session-c_en.pdf"},
    {"id":"61651","name":"Presentation - Validation of digital endpoints - Setting the scene (breakout session D)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T17:04:46Z","last_updated_date":"2024-01-05T17:04:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-validation-digital-endpoints-setting-scene-breakout-session-d_en.pdf"},
    {"id":"61652","name":"Presentation - Patient centricity diversity and representativeness in clinical trials - Industry perspective (breakout session F)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T17:06:16Z","last_updated_date":"2024-01-05T17:06:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-centricity-diversity-and-representativeness-clinical-trials-industry-perspective-breakout-session-f_en.pdf"},
    {"id":"61653","name":"Presentation - Decentralised clinical trials, new directions - Academic perspective (breakout session G)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T17:08:42Z","last_updated_date":"2024-01-05T17:08:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-decentralised-clinical-trials-new-directions-academic-perspective-breakout-session-g_en.pdf"},
    {"id":"61654","name":"Presentation - Complex clinical trials, focus on platform trials - Industry perspective (breakout session H)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-05T17:10:14Z","last_updated_date":"2024-01-05T17:10:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-complex-clinical-trials-focus-platform-trials-industry-perspective-breakout-session-h_en.pdf"},
    {"id":"61655","name":"eXtended EudraVigilance medicinal product dictionary (XEVMPD) live virtual training course for sponsors","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-01-08T10:46:46Z","last_updated_date":"2024-01-08T10:46:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/extended-eudravigilance-medicinal-product-dictionary-xevmpd-live-virtual-training-course-sponsors_en.pdf"},
    {"id":"61656","name":"European Medicines Agency budget for 2024","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2024-01-08T12:47:01Z","last_updated_date":"2024-01-08T12:47:01Z","reference_number":"EMA/533652/2023","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-budget-2024_en.pdf"},
    {"id":"61665","name":"Decision of the Management Board Amending budget No. 01, amending appropriations in budget 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-08T16:37:53Z","last_updated_date":"2024-01-08T16:37:53Z","reference_number":"EMA/575753/2023","document_url":"https://www.ema.europa.eu/en/documents/other/decision-management-board-amending-budget-no-01-amending-appropriations-budget-2023_en.pdf"},
    {"id":"61635","name":"Presentation - CTIS Bitesize Talk - IMPD-Q-only Submission","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2023-06-07T17:05:24Z","last_updated_date":"2023-06-07T17:05:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-bitesize-talk-impd-q-only-submission_en.pdf"},
    {"id":"61667","name":"European Medicines Agency’s privacy statement for the visitor management application","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:04:23Z","last_updated_date":"2024-01-09T13:04:23Z","reference_number":"EMA/233274/2021","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-visitor-management-application_en.pdf"},
    {"id":"61669","name":"Presentation - Insight from EMA on recent scientific advice developments (I. Gravanis and K. Cunningham)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:17:41Z","last_updated_date":"2024-01-09T13:17:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-insight-ema-recent-scientific-advice-developments-i-gravanis-and-k-cunningham_en.pdf"},
    {"id":"61670","name":"Presentation - EMA multistakeholder workshop on Qualification of Novel Methodologies (QoNM) – Outcome report and Recommendations (I. Gravanis, and T.Vetter, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:20:09Z","last_updated_date":"2024-01-09T13:20:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-multistakeholder-workshop-qualification-novel-methodologies-qonm-outcome-report-and-recommendations-i-gravanis-and-tvetter-ema_en.pdf"},
    {"id":"61671","name":"Presentation - An agency of the European Union Portfolio & Technology Meetings (E. Tognana, EMA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:21:40Z","last_updated_date":"2024-01-09T13:21:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/presentation-agency-european-union-portfolio-technology-meetings-e-tognana-ema_en.pdf"},
    {"id":"61672","name":"Presentation - Recent and upcoming developments of the IRIS platform for R&D processes (T. Toufexi and A. Gross, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:22:55Z","last_updated_date":"2024-01-09T13:22:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recent-and-upcoming-developments-iris-platform-rd-processes-t-toufexi-and-gross-ema_en.pdf"},
    {"id":"61673","name":"Presentation - the Stepwise Paediatric Investigation Plan (sPIP) (C. Pallidis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:24:39Z","last_updated_date":"2024-01-09T13:24:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stepwise-paediatric-investigation-plan-spip-c-pallidis-ema_en.pdf"},
    {"id":"61674","name":"Presentation - Feedback from the latest discussions of the Focus group-agreed actions and next steps (S. Aarum, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-09T13:26:26Z","last_updated_date":"2024-01-09T13:26:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-latest-discussions-focus-group-agreed-actions-and-next-steps-s-aarum-ema_en.pdf"},
    {"id":"45354","name":"Public statement on Daklinza: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2019-08-30T09:55:00Z","last_updated_date":"2019-08-30T09:55:00Z","reference_number":"EMA/476687/2019","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-daklinza-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"61287","name":"Agenda - EMA EORTC workshop on soft tissue and sarcoma ","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-12-06T17:12:13Z","last_updated_date":"2024-01-09T17:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-eortc-workshop-soft-tissue-and-sarcoma_en.pdf"},
    {"id":"61711","name":"Annual report of the Pharmacovigilance Inspectors Working Group for 2021-2022","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2024-01-10T17:14:15Z","last_updated_date":"2024-01-10T17:14:15Z","reference_number":"EMA/420038/2023","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-pharmacovigilance-inspectors-working-group-2021-2022_en.pdf"},
    {"id":"61684","name":"Presentation - Session 1 :  Report on implementation of the HMA-EMA Big Data Task Force priority recommendations - 4th year into our journey to data driven regulation (P. Arlett, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T12:39:01Z","last_updated_date":"2024-01-11T12:39:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-report-implementation-hma-ema-big-data-task-force-priority-recommendations-4th-year-our-journey-data-driven-regulation-p-arlett-ema_en.pdf"},
    {"id":"61685","name":"Presentation - Session 2 : Changing the discoverability and data quality of EU data ecosystem (S. Perez-Gutthann, ENCePP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T12:43:32Z","last_updated_date":"2024-01-11T12:43:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-changing-discoverability-and-data-quality-eu-data-ecosystem-s-perez-gutthann-encepp_en.pdf"},
    {"id":"61686","name":"Presentation - Session 2 : Enabling the use and establishing the value of Real-World Evidence – EHDS2 Pilot first insights (D. Umuhire, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T12:46:40Z","last_updated_date":"2024-01-11T12:46:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-enabling-use-and-establishing-value-real-world-evidence-ehds2-pilot-first-insights-d-umuhire-ema_en.pdf"},
    {"id":"61687","name":"Presentation - Session 2 : How are RWE transforming the EU regulatory network (K. Roes, CBG-MEB)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T12:48:59Z","last_updated_date":"2024-01-11T12:48:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-how-are-rwe-transforming-eu-regulatory-network-k-roes-cbg-meb_en.pdf"},
    {"id":"61688","name":"Presentation - Session 2 : Using RWE. Pilots from DARWIN-EU (W. Goettsch, HTA ZIN)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T12:50:54Z","last_updated_date":"2024-01-11T12:50:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-using-rwe-pilots-darwin-eu-w-goettsch-hta-zin_en.pdf"},
    {"id":"61689","name":"Presentation - Session 2 : Progress on convergence with international partners on Real World Data (M. Kampman, Health Canada)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T12:58:01Z","last_updated_date":"2024-01-11T12:58:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-progress-convergence-international-partners-real-world-data-m-kampman-health-canada_en.pdf"},
    {"id":"61693","name":"Presentation - Session 3 : Realising the potential of PED in EU medicine regulation - BDSG workplan opportunities to enhance use of PED for regulatory decision making (G. Paliouras, NCSR “Demokritos”; DDF)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:36:27Z","last_updated_date":"2024-01-11T13:36:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-realising-potential-ped-eu-medicine-regulation-bdsg-workplan-opportunities-enhance-use-ped-regulatory-decision-making-g-paliouras-ncsr-demokritos-ddf_en.pdf"},
    {"id":"61694","name":"Presentation - Session 3 : Patient engagement in research area at Barcelona Children’s Hospital (B. Nafria, Saint  Joan de Deus Children’s Hospital)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:43:23Z","last_updated_date":"2024-01-11T13:43:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-patient-engagement-research-area-barcelona-childrens-hospital-b-nafria-saint-joan-de-deus-childrens-hospital_en.pdf"},
    {"id":"61695","name":"Presentation - Session 3 : The role of healthcare professionals (D. Makridaki, EAHP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:49:57Z","last_updated_date":"2024-01-11T13:49:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-role-healthcare-professionals-d-makridaki-eahp_en.pdf"},
    {"id":"61696","name":"Presentation - Session 3 : Real World Evidence: The PROFILES registry (L. van de Poll-Franse, NCI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:53:00Z","last_updated_date":"2024-01-11T13:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-real-world-evidence-profiles-registry-l-van-de-poll-franse-nci_en.pdf"},
    {"id":"61697","name":"Presentation - Session 3 : Patient Experience Data (PED) - Realising the potential of PED in EU medicine regulation (M. Cavaller Bellaubi, EURORDIS)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:55:47Z","last_updated_date":"2024-01-11T13:55:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-patient-experience-data-ped-realising-potential-ped-eu-medicine-regulation-m-cavaller-bellaubi-eurordis_en.pdf"},
    {"id":"61698","name":"Presentation - Session 3 : State of play and ongoing regulatory initiatives (R. Gonzalez-Quevedo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:58:33Z","last_updated_date":"2024-01-11T13:58:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-state-play-and-ongoing-regulatory-initiatives-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"61699","name":"Presentation - Session 3 : What is needed by regulators (B. Sepodes, CHMP, INFARMED and S. Straus, PRAC, MEB)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T14:01:48Z","last_updated_date":"2024-01-11T14:01:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-what-needed-regulators-b-sepodes-chmp-infarmed-and-s-straus-prac-meb_en.pdf"},
    {"id":"61702","name":"Presentation - Session 4 : Advances in digital technologies to enable collection of Patient Experience Data (J. Isla, DSEF)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T15:41:21Z","last_updated_date":"2024-01-11T15:41:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-advances-digital-technologies-enable-collection-patient-experience-data-j-isla-dsef_en.pdf"},
    {"id":"61703","name":"Presentation - Session 4 : Quantum computing: a game-changing approach for drug development (A. H. Werner, University of Copenhagen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T15:44:41Z","last_updated_date":"2024-01-11T15:44:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-quantum-computing-game-changing-approach-drug-development-h-werner-university-copenhagen_en.pdf"},
    {"id":"61704","name":"Presentation - Session 4 : Regulatory preparedness on Artificial Intelligence: AI workplan (G. Westman, MPA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T15:46:57Z","last_updated_date":"2024-01-11T15:46:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-regulatory-preparedness-artificial-intelligence-ai-workplan-g-westman-mpa_en.pdf"},
    {"id":"61705","name":"Presentation - Session 4 : Use of external data to accelerate evidence generation - digital twins and external controls (H. Fröhlich, Fraunhofer SCAI)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T15:48:34Z","last_updated_date":"2024-01-11T15:48:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-use-external-data-accelerate-evidence-generation-digital-twins-and-external-controls-h-frohlich-fraunhofer-scai_en.pdf"},
    {"id":"61706","name":"Presentation - Session 5 : Data, not dogma: How data analysis can supercharge evidence-based decision making (A. Aerts, The Novartis Foundation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T15:52:06Z","last_updated_date":"2024-01-11T15:52:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-5-data-not-dogma-how-data-analysis-can-supercharge-evidence-based-decision-making-aerts-novartis-foundation_en.pdf"},
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    {"id":"55714","name":"Workplan 2022-2025: HMA-EMA joint Big Data Steering Group","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2022-07-28T10:11:00Z","last_updated_date":"2022-07-28T10:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/work-programme/workplan-2022-2025-hma-ema-joint-big-data-steering-group_en.pdf"},
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    {"id":"48782","name":"Workplan 2020: HMA-EMA joint Big Data Steering Group","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2020-09-14T10:40:00Z","last_updated_date":"2020-09-30T09:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/work-programme/workplan-2020-hma-ema-joint-big-data-steering-group_en.pdf"},
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    {"id":"61768","name":"Chlorpromazine : List of nationally authorised medicinal products - PSUSA/00000715/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-15T15:37:35Z","last_updated_date":"2024-01-15T15:37:35Z","reference_number":"EMA/795/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorpromazine-list-nationally-authorised-medicinal-products-psusa-00000715-202305_en.pdf"},
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    {"id":"61544","name":"European medicines  agencies network  strategy to 2025: Mid-point report to Q2 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2023-12-20T16:00:00Z","last_updated_date":"2023-12-20T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agencies-network-strategy-2025-mid-point-report-q2-2023_en.pdf"},
    {"id":"61772","name":"Human medicines highlights 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-16T11:00:25Z","last_updated_date":"2024-01-16T11:00:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/human-medicines-highlights-2023_en.pdf"},
    {"id":"61779","name":"Zuclopenthixol : List of nationally authorised medicinal products - PSUSA/00003155/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-16T13:07:47Z","last_updated_date":"2024-01-16T13:07:47Z","reference_number":"EMA/21143/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/zuclopenthixol-list-nationally-authorised-medicinal-products-psusa-00003155-202305_en.pdf"},
    {"id":"61782","name":"Final European Union herbal monograph on Cnicus benedictus L., herba","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2024-01-16T14:31:28Z","last_updated_date":"2024-01-16T14:31:28Z","reference_number":"EMA/HMPC/32402/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-cnicus-benedictus-l-herba_en.pdf"},
    {"id":"61783","name":"Opinion of the HMPC on a European Union herbal monograph on Cnicus benedictus L., herba","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2024-01-16T14:34:10Z","last_updated_date":"2024-01-16T14:34:10Z","reference_number":"EMA/HMPC/M/H/0259","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-cnicus-benedictus-l-herba_en.pdf"},
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    {"id":"61785","name":"Final list of references supporting the assessment of Cnicus benedictus L., herba","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2024-01-16T14:38:32Z","last_updated_date":"2024-01-16T14:38:32Z","reference_number":"EMA/HMPC/32403/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-cnicus-benedictus-l-herba_en.pdf"},
    {"id":"60363","name":"Use of EDQM terminologies for Dose Forms and Routes of Administration for Individual  Case Safety Reports in E2B(R3) message ","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-10-11T11:36:00Z","last_updated_date":"2024-01-16T15:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/use-edqm-terminologies-dose-forms-and-routes-administration-individual-case-safety-reports-e2br3-message_en.pdf"},
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    {"id":"46598","name":"Categorisation of antibiotics used in animals promotes responsible use to protect public and animal health","type":"press-release","status":"unknown","consultation_date":"","first_published_date":"2020-01-28T13:02:00Z","last_updated_date":"2020-01-28T13:02:00Z","reference_number":"EMA/688114/2020","document_url":"https://www.ema.europa.eu/en/documents/press-release/categorisation-antibiotics-used-animals-promotes-responsible-use-protect-public-and-animal-health_en.pdf"},
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    {"id":"29954","name":"Chapter 3.I: Technical specifications of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-03-05T12:00:00Z","last_updated_date":"2024-01-18T09:00:00Z","reference_number":"EMA/101344/2012","document_url":"https://www.ema.europa.eu/en/documents/other/chapter-3i-technical-specifications-detailed-guidance-electronic-submission-information-medicinal-products-human-use-marketing-authorisation-holders-ema_en.pdf"},
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    {"id":"61811","name":"CVMP post-authorisation summary of positive opinion for Metacam (VRA-0151-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-01-19T12:07:28Z","last_updated_date":"2024-01-19T12:07:28Z","reference_number":"EMA/CVMP/10551/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-metacam-vra-0151-g_en.pdf"},
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    {"id":"57594","name":"PRAC recommends measures to minimise the risk of serious side effects with medicines containing pseudoephedrine","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-12-01T12:00:00Z","last_updated_date":"2023-12-01T12:00:00Z","reference_number":"EMA/535476/2023","document_url":"https://www.ema.europa.eu/en/documents/referral/prac-recommends-measures-minimise-risk-serious-side-effects-medicines-containing-pseudoephedrine_en.pdf"},
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    {"id":"61819","name":"What is the meaning of the terms \"unresolved\" and \"outstanding\" in Article 8(3), Article 22(2)(e)(vi) and Article 22(3)(d)(ii) of the Commission Implementing Regulation (EU) 2021/1281","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T11:56:25Z","last_updated_date":"2024-01-22T11:56:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/what-meaning-terms-unresolved-and-outstanding-article-83-article-222evi-and-article-223dii-commission-implementing-regulation-eu-2021-1281_en.pdf"},
    {"id":"61821","name":"Presentation - Introduction of the EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma by the chair (P. Demolis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T13:54:54Z","last_updated_date":"2024-01-22T13:54:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-ema-and-eortc-multi-stakeholder-workshop-soft-tissue-and-bone-sarcoma-chair-p-demolis_en.pdf"},
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    {"id":"61824","name":"Presentation - EMA regulatory framework for rare disease (R. Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T14:00:34Z","last_updated_date":"2024-01-22T14:00:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-regulatory-framework-rare-disease-r-herold_en.pdf"},
    {"id":"61825","name":"Presentation - Ultra-rare Sarcoma major challenges and opportunities (H. Leonard and J. Summer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T14:09:20Z","last_updated_date":"2024-01-22T14:09:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ultra-rare-sarcoma-major-challenges-and-opportunities-h-leonard-and-j-summer_en.pdf"},
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    {"id":"61827","name":"Presentation - Lessons learned from the compassionate use program (T. De Rojas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T14:23:54Z","last_updated_date":"2024-01-22T14:23:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lessons-learned-compassionate-use-program-t-de-rojas_en.pdf"},
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    {"id":"61820","name":"Agenda - EMA multi-stakeholder workshop on the guideline on clinical investigation of medicinal products in the treatment of epileptic disorders","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T12:00:58Z","last_updated_date":"2024-01-22T18:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-multi-stakeholder-workshop-guideline-clinical-investigation-medicinal-products-treatment-epileptic-disorders_en.pdf"},
    {"id":"61840","name":"Direct healthcare professional communication (DHPC) : Leqvio (inclisiran) 284 mg solution for injection in pre-filled syringe: Important information regarding instructions for use before injection","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-01-23T12:39:53Z","last_updated_date":"2024-01-23T12:39:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-leqvio-inclisiran-284-mg-solution-injection-pre-filled-syringe-important-information-regarding-instructions-use-injection_en.pdf"},
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    {"id":"61833","name":"Presentation - A prospective master protocol and platform to conduct international SATs (L. D'Ambrosio, G. Bouche, R. Miceli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-01-22T14:39:16Z","last_updated_date":"2024-01-22T14:39:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-prospective-master-protocol-and-platform-conduct-international-sats-l-dambrosio-g-bouche-r-miceli_en.pdf"},
    {"id":"60808","name":"Appendix 2 : Carcinogenic Potency Categorisation Approach for N-nitrosamines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-11-09T11:54:00Z","last_updated_date":"2023-11-09T11:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/appendix-2-carcinogenic-potency-categorisation-approach-n-nitrosamines_en.pdf"},
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    {"id":"62506","name":"Presentation - Third party interventions for WP - Fabrizio Boccacci","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:27:16Z","last_updated_date":"2024-03-08T16:27:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-third-party-interventions-wp-fabrizio-boccacci_en.pdf"},
    {"id":"62507","name":"Presentation - Cancer Medicines as pathfinder - Francesco Pignatti","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:28:17Z","last_updated_date":"2024-03-08T16:28:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cancer-medicines-pathfinder-francesco-pignatti_en.pdf"},
    {"id":"62508","name":"Presentation - Conversations on cancer - Caroline Voltz","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:29:22Z","last_updated_date":"2024-03-08T16:29:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-conversations-cancer-caroline-voltz_en.pdf"},
    {"id":"62509","name":"Presentation - Patient experience data reflection paper - Rosa Gonzalez-Quevedo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:30:19Z","last_updated_date":"2024-03-08T16:30:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-reflection-paper-rosa-gonzalez-quevedo_en.pdf"},
    {"id":"62510","name":"Presentation - Patient experience data and therapeutic areas - Survey - Rosa Gonzalez-Quevedo","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:31:16Z","last_updated_date":"2024-03-08T16:31:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-therapeutic-areas-survey-rosa-gonzalez-quevedo_en.pdf"},
    {"id":"62511","name":"Presentation - Update on EU Network Training Centre - Esther Martinez","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:32:10Z","last_updated_date":"2024-03-08T16:32:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-eu-network-training-centre-esther-martinez_en.pdf"},
    {"id":"62512","name":"Presentation - Preparation of amendments to EC Implementing Regulation 5202012 on the performance of pharmacovigilance activities - Izabela Taborska","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:33:01Z","last_updated_date":"2024-03-08T16:33:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preparation-amendments-ec-implementing-regulation-5202012-performance-pharmacovigilance-activities-izabela-taborska_en.pdf"},
    {"id":"62513","name":"Presentation - Risk minimisation for patient safety – update on policies and practices - Priya Bahri","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:33:50Z","last_updated_date":"2024-03-08T16:33:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-minimisation-patient-safety-update-policies-practices-priya-bahri_en.pdf"},
    {"id":"62514","name":"Presentation - European Network of Paediatric Research at EMA - Gunter Egger","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:34:53Z","last_updated_date":"2024-03-08T16:34:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-network-paediatric-research-ema-gunter-egger_en.pdf"},
    {"id":"62515","name":"Presentation - PL improvement - Monica Buch","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:35:56Z","last_updated_date":"2024-03-08T16:35:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pl-improvement-monica-buch_en.pdf"},
    {"id":"62516","name":"Presentation - Feedback from stakeholders of the subgroup - Courtney Davis","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:36:53Z","last_updated_date":"2024-03-08T16:36:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-stakeholders-subgroup-courtney-davis_en.pdf"},
    {"id":"62517","name":"Presentation - Debriefing EMA workshop on Long COVID - Stephanie Buchhol","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:37:50Z","last_updated_date":"2024-03-08T16:37:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-debriefing-ema-workshop-long-covid-stephanie-buchhol_en.pdf"},
    {"id":"62518","name":"Presentation - Input Long COVID Europe on Long Covid Trials - Chantal Britt","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:38:45Z","last_updated_date":"2024-03-08T16:38:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-input-long-covid-europe-long-covid-trials-chantal-britt_en.pdf"},
    {"id":"62519","name":"Presentation - ACT EU update - Ana Zanoletty","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:40:24Z","last_updated_date":"2024-03-08T16:40:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-act-eu-update-ana-zanoletty_en.pdf"},
    {"id":"62520","name":"Presentation - Data discoverability HMA-EMA Catalogues of Real-World Data sources and studies - Ana Cochino","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:41:05Z","last_updated_date":"2024-03-08T16:41:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-discoverability-hma-ema-catalogues-real-world-data-sources-studies-ana-cochino_en.pdf"},
    {"id":"62521","name":"Presentation - EU list of critical medicines_launch of Phase 2 - Joao Francisco Ferreira","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:42:00Z","last_updated_date":"2024-03-08T16:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-list-critical-medicines_launch-phase-2-joao-francisco-ferreira_en.pdf"},
    {"id":"62522","name":"Glucagon-like Peptide-1 (GLP1) Receptor Agonists - Klaus Kruttwig, Romana Micovcakova","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:42:50Z","last_updated_date":"2024-03-08T16:42:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/glucagon-peptide-1-glp1-receptor-agonists-klaus-kruttwig-romana-micovcakova_en.pdf"},
    {"id":"24280","name":"Final  European Union herbal monograph on Symphytum officinale L., radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2015-06-05T02:00:00Z","last_updated_date":"2015-06-05T02:00:00Z","reference_number":"EMA/HMPC/572846/2009 Corr 1","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-symphytum-officinale-l-radix_en.pdf"},
    {"id":"62457","name":"Addendum to Assessment report on Symphytum officinale L., radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2024-03-11T09:10:51Z","last_updated_date":"2024-03-11T09:10:51Z","reference_number":"EMA/HMPC/313662/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-symphytum-officinale-l-radix_en.pdf"},
    {"id":"62533","name":"Presentation - Patients’ Involvement, what Does that Mean? Variability between diseases and patients (P. Demolis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:41:08Z","last_updated_date":"2024-03-11T14:41:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-involvement-what-does-mean-variability-between-diseases-patients-p-demolis_en.pdf"},
    {"id":"62534","name":"Presentation - Evaluating cancer treatments based on overall survival and quality of life (W. van der Graaf)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:48:04Z","last_updated_date":"2024-03-11T14:48:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evaluating-cancer-treatments-based-overall-survival-quality-life-w-van-der-graaf_en.pdf"},
    {"id":"62535","name":"Presentation - The tale of two trials: Improving the use of PROs and HRQoLin cancer clinical research (J. Reijneveld)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:50:02Z","last_updated_date":"2024-03-11T14:50:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-tale-two-trials-improving-use-pros-hrqolin-cancer-clinical-research-j-reijneveld_en.pdf"},
    {"id":"62537","name":"Presentation - Learnings from a review of patient reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020 (C. Torre)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:53:07Z","last_updated_date":"2024-03-11T14:53:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-learnings-review-patient-reported-outcomes-used-regulatory-approval-oncology-medicinal-products-european-union-between-2017-2020-c-torre_en.pdf"},
    {"id":"62538","name":"Presentation - Patient-Reported Outcomes in Oncology Trials (V. Bhatnagar)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:56:05Z","last_updated_date":"2024-03-11T14:56:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-reported-outcomes-oncology-trials-v-bhatnagar_en.pdf"},
    {"id":"62539","name":"Presentation - Application and importance of HRQoL/PRO assessment from the HTA perspective (B. Wieseler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:57:02Z","last_updated_date":"2024-03-11T14:57:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-application-importance-hrqol-pro-assessment-hta-perspective-b-wieseler_en.pdf"},
    {"id":"62540","name":"Presentation - Enhancing Benefit Risk Assessment: Integrating Survival Data and Longitudinal Patient reported Outcome Data (D. Postmus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:58:18Z","last_updated_date":"2024-03-11T14:58:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enhancing-benefit-risk-assessment-integrating-survival-data-longitudinal-patient-reported-outcome-data-d-postmus_en.pdf"},
    {"id":"62541","name":"Presentation - EORTC’s strategy on the development and implementation of PRO and HRQoLmeasures for cancer clinical research (M. Groenvold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:59:05Z","last_updated_date":"2024-03-11T14:59:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eortcs-strategy-development-implementation-pro-hrqolmeasures-cancer-clinical-research-m-groenvold_en.pdf"},
    {"id":"62542","name":"Presentation - Measuring HRQOL core outcomesand disease-specific symptoms (Classified as public by the European Medicines Agency (J. M. Giesinger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T15:00:01Z","last_updated_date":"2024-03-11T15:00:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-measuring-hrqol-core-outcomesand-disease-specific-symptoms-classified-public-european-medicines-agency-j-m-giesinger_en.pdf"},
    {"id":"62543","name":"Presentation - Measuring treatment-specific side effects from the patient perspective: Trial-specific item lists from PRO item libraries (A. Gilbert, C. Piccinin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T15:01:01Z","last_updated_date":"2024-03-11T15:01:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-measuring-treatment-specific-side-effects-patient-perspective-trial-specific-item-lists-pro-item-libraries-gilbert-c-piccinin_en.pdf"},
    {"id":"62544","name":"Presentation - Use of static and flexible PRO measures in global cancer trials: Challenges and opportunities (J. Shaw)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T15:02:13Z","last_updated_date":"2024-03-11T15:02:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-static-flexible-pro-measures-global-cancer-trials-challenges-opportunities-j-shaw_en.pdf"},
    {"id":"62536","name":"Presentation - EMA current and future activities on Patient Experience Data (PED), including PROs and HRQoL in medicines’ development and evaluation (J. Garcia Burgos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T14:51:22Z","last_updated_date":"2024-03-11T14:51:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-current-future-activities-patient-experience-data-ped-including-pros-hrqol-medicines-development-evaluation-j-garcia-burgos-ema_en.pdf"},
    {"id":"62545","name":"Agenda of the CVMP meeting 12-14 March 2024","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-03-11T16:33:02Z","last_updated_date":"2024-03-11T16:33:02Z","reference_number":"EMA/107153/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-12-14-march-2024_en.pdf"},
    {"id":"12145","name":"CHMP summary of positive opinion for Pramipexole Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2011-07-22T02:00:00Z","last_updated_date":"2024-03-11T02:00:00Z","reference_number":"EMA/CHMP/507521/2011","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pramipexole-accord_en.pdf"},
    {"id":"62546","name":"Public statement on Pramipexole Accord : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2024-03-11T17:00:52Z","last_updated_date":"2024-03-11T17:00:52Z","reference_number":"EMA/99746/2024","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pramipexole-accord-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"61382","name":"Agenda - DARWIN EU Advisory Board - 24 May 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-12-12T12:36:07Z","last_updated_date":"2023-12-12T12:36:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-darwin-eu-advisory-board-24-may-2023_en.pdf"},
    {"id":"62554","name":"Minutes – DARWIN EU Advisory Board - 24 May 2023","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T14:25:03Z","last_updated_date":"2024-03-12T14:25:03Z","reference_number":"EMA/238242/2023","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-darwin-eu-advisory-board-24-may-2023_en.pdf"},
    {"id":"62555","name":"Agenda - DARWIN EU Advisory Board - 11 December 2023","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T14:38:04Z","last_updated_date":"2024-03-12T14:38:04Z","reference_number":"EMA/423117/2023","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-darwin-eu-advisory-board-11-december-2023_en.pdf"},
    {"id":"60361","name":"Agenda - Second listen-and-learn focus group meeting of the Quality Innovation Group","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2023-10-11T10:23:00Z","last_updated_date":"2024-03-12T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-listen-learn-focus-group-meeting-quality-innovation-group_en.pdf"},
    {"id":"62557","name":"Oxytocin (systemic use) : List of nationally authorised medicinal products - PSUSA/00010913/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T15:16:59Z","last_updated_date":"2024-03-12T15:16:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxytocin-systemic-use-list-nationally-authorised-medicinal-products-psusa-00010913-202306_en.pdf"},
    {"id":"62558","name":"List of withdrawn medicinal products","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T15:19:52Z","last_updated_date":"2024-03-12T15:19:52Z","reference_number":"EMA/569891/2023","document_url":"https://www.ema.europa.eu/en/documents/report/list-withdrawn-medicinal-products_en.xlsx"},
    {"id":"62569","name":"Cyproterone / Ethinylestradiol List of nationally authorised medicinal products - PSUSA/00000906/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T16:24:06Z","last_updated_date":"2024-03-12T16:24:06Z","reference_number":"EMA/110565/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyproterone-ethinylestradiol-list-nationally-authorised-medicinal-products-psusa-00000906-202305_en.pdf"},
    {"id":"62570","name":"Presentation - Opening remarks (Anja van Haren)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:11:58Z","last_updated_date":"2024-03-12T17:11:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opening-remarks-anja-van-haren_en.pdf"},
    {"id":"62571","name":"Presentation - Opening remarks (James Mount)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:13:18Z","last_updated_date":"2024-03-12T17:13:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opening-remarks-james-mount_en.pdf"},
    {"id":"62572","name":"Presentation - Opening remarks (Elke Stahl)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:14:16Z","last_updated_date":"2024-03-12T17:14:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opening-remarks-elke-stahl_en.pdf"},
    {"id":"62573","name":"Presentation - Data Quality Framework overview (Ana Cochino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:15:07Z","last_updated_date":"2024-03-12T17:15:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-quality-framework-overview-ana-cochino_en.pdf"},
    {"id":"62574","name":"Presentation - Guidance, standards, EMA Data Quality activities and uses of ADR data human & veterinary (Tom Paternoster)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:16:11Z","last_updated_date":"2024-03-12T17:16:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-guidance-standards-ema-data-quality-activities-uses-adr-data-human-veterinary-tom-paternoster_en.pdf"},
    {"id":"62575","name":"Presentation - Human NCA Data Quality activities and uses of ADR data (Elena Rodionova)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:17:20Z","last_updated_date":"2024-03-12T17:17:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-human-nca-data-quality-activities-uses-adr-data-elena-rodionova_en.pdf"},
    {"id":"62576","name":"Presentation – Veterinary NCA Data Quality activities and uses of ADR data (Kathrin Schirmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:18:09Z","last_updated_date":"2024-03-12T17:18:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-nca-data-quality-activities-uses-adr-data-kathrin-schirmann_en.pdf"},
    {"id":"62577","name":"Presentation - Stakeholder ADR data quality activities in Europe -Human MAH (Jim Nickas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:18:48Z","last_updated_date":"2024-03-12T17:18:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stakeholder-adr-data-quality-activities-europe-human-mah-jim-nickas_en.pdf"},
    {"id":"62578","name":"Presentation - Stakeholder ADR data quality activities in Europe - CRO (Zurab Koberidze)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:20:27Z","last_updated_date":"2024-03-12T17:20:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stakeholder-adr-data-quality-activities-europe-cro-zurab-koberidze_en.pdf"},
    {"id":"62579","name":"Presentation - Stakeholder ADR data quality activities in Europe - Veterinary MAH (Magali Quetin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-03-12T17:21:31Z","last_updated_date":"2024-03-12T17:21:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-stakeholder-adr-data-quality-activities-europe-veterinary-mah-magali-quetin_en.pdf"},
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    {"id":"62898","name":"Presentation - Cancer Medicines Forum - innovative evidence generation: OCE project Pragmatica (D. R. Rivera, FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-04-11T09:26:25Z","last_updated_date":"2024-04-11T09:26:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cancer-medicines-forum-innovative-evidence-generation-oce-project-pragmatica-d-r-rivera-fda_en.pdf"},
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    {"id":"30447","name":"Opinion of the CVMP pursuant to Article 30(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council on dapsone as an impurity in veterinary medicinal products containing sulphamethoxazole or other ...","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-04T01:00:00Z","last_updated_date":"2013-02-04T01:00:00Z","reference_number":"EMA/CVMP/392253/2012","document_url":"https://www.ema.europa.eu/en/documents/other/opinion-cvmp-pursuant-article-303-regulation-ec-no-726-2004-european-parliament-council-dapsone-impurity-veterinary-medicinal-products-containing-sulphamethoxazole-or-other_en.pdf"},
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    {"id":"62973","name":"Presentation - Session 2 - CTIS Last year of transition (Lene Grejs Petersen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-04-16T12:18:46Z","last_updated_date":"2024-04-16T12:18:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-ctis-last-year-transition-lene-grejs-petersen_en.pdf"},
    {"id":"62974","name":"Presentation - Session 2 CTIS Webinar Last Year of Transition (Martin OKane)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-04-16T12:21:06Z","last_updated_date":"2024-04-16T12:21:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-ctis-webinar-last-year-transition-martin-okane_en.pdf"},
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    {"id":"62985","name":"Guideline on VICH GL61 Pharmaceutical Development","type":"scientific-guideline","status":"Draft","consultation_date":"2024-03-15 - 2024-08-15","first_published_date":"2024-04-17T12:35:18Z","last_updated_date":"2024-04-17T12:35:18Z","reference_number":"EMA/CVMP/841162/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-vich-gl61-pharmaceutical-development_en.pdf"},
    {"id":"62990","name":"Dienogest / estradiol (contraception indication) : List of nationally authorised medicinal products - PSUSA/00010444/202309","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-17T15:40:14Z","last_updated_date":"2024-04-17T15:40:14Z","reference_number":"EMA/167446/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/dienogest-estradiol-contraception-indication-list-nationally-authorised-medicinal-products-psusa-00010444-202309_en.pdf"},
    {"id":"55645","name":"All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-03-04T12:00:00Z","last_updated_date":"2024-03-04T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/all-languages-annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human-use-sante-2017-11668-revision-3_en.xlsx"},
    {"id":"61493","name":"Zynrelef: public statement - Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T09:21:00Z","last_updated_date":"2023-12-19T09:21:00Z","reference_number":"EMA/453895/2023","document_url":"https://www.ema.europa.eu/en/documents/public-statement/zynrelef-public-statement-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"63411","name":"CHMP summary of positive opinion for Apexelsin","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-05-31T12:00:00Z","last_updated_date":"2024-05-31T12:00:00Z","reference_number":"EMEA/250328/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-apexelsin_en.pdf"},
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    {"id":"60010","name":"Mysimba Article-20 procedure - CHMP List of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-09-15T10:14:00Z","last_updated_date":"2024-05-31T12:20:00Z","reference_number":"EMA/CHMP/236208/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/mysimba-article-20-procedure-chmp-list-questions_en.pdf"},
    {"id":"63288","name":"Agenda - Product Management Service (PMS) Product UI training (access & navigation)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-05-21T15:49:26Z","last_updated_date":"2024-05-31T15:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-product-management-service-pms-product-ui-training-access-navigation_en.pdf"},
    {"id":"49186","name":"CVMP summary of positive opinion for Enteroporc Coli","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-11-06T12:31:00Z","last_updated_date":"2024-05-31T15:00:00Z","reference_number":"EMA/CVMP/551905/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-enteroporc-coli_en.pdf"},
    {"id":"63448","name":" CTIS newsflash - 31 May 2024","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2024-06-03T09:44:01Z","last_updated_date":"2024-06-03T09:44:01Z","reference_number":"EMA/240597/2024","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-31-may-2024_en.pdf"},
    {"id":"63412","name":"CHMP post-authorisation summary of positive opinion for Tevimbra (II-08)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-05-31T12:00:00Z","last_updated_date":"2024-05-31T12:00:00Z","reference_number":"EMA/CHMP/245593/2024 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tevimbra-ii-08_en.pdf"},
    {"id":"61365","name":"CVMP post-authorisation summary of positive opinion for Bravecto (VRA-0059)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2023-12-11T17:41:50Z","last_updated_date":"2023-12-11T17:41:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-bravecto-vra-0059_en.pdf"},
    {"id":"63457","name":"Awiqli : measures intended to reduce risk of confusion with dosing requirements","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2024-06-03T13:04:00Z","last_updated_date":"2024-06-03T13:04:00Z","reference_number":"EMA/137463/2024","document_url":"https://www.ema.europa.eu/en/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_da.pdf","de":"https://www.ema.europa.eu/de/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_de.pdf","et":"https://www.ema.europa.eu/et/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_et.pdf","el":"https://www.ema.europa.eu/el/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medication-error/awiqli-measures-intended-reduce-risk-confusion-dosing-requirements_sv.pdf"}},
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    {"id":"60420","name":"Ocaliva Article 20 procedure : Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2023-10-13T11:53:00Z","last_updated_date":"2024-06-03T11:14:00Z","reference_number":"EMA/CHMP/448947/2023 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/referral/ocaliva-article-20-procedure-timetable-procedure_en.pdf"},
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    {"id":"63466","name":"SNSA final advice report template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2024-06-03T17:00:00Z","last_updated_date":"2024-06-03T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/snsa-final-advice-report-template_en.doc"},
    {"id":"62736","name":"Amended EU recommendations for the seasonal influenza vaccine composition for the season 2024/2025","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-03-26T11:58:00Z","last_updated_date":"2024-06-03T17:51:00Z","reference_number":"EMA/60123/2024","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/amended-eu-recommendations-seasonal-influenza-vaccine-composition-season-2024-2025_en.pdf"},
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    {"id":"62901","name":"Human medicines highlights - April 2024","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2024-04-11T11:21:34Z","last_updated_date":"2024-04-11T11:21:34Z","reference_number":"Issue 179","document_url":"https://www.ema.europa.eu/en/documents/newsletter/human-medicines-highlights-april-2024_en.pdf"},
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    {"id":"63371","name":"Public engagement highlights 2023","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2024-05-29T15:40:57Z","last_updated_date":"2024-05-29T15:40:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/public-engagement-highlights-2023_en.pdf"},
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    {"id":"56347","name":"CVMP post-authorisation summary of positive opinion for Simparica (WS)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-10-07T13:37:00Z","last_updated_date":"2022-10-07T13:37:00Z","reference_number":"EMA/CVMP/780812/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-simparica-ws_en.pdf"},
    {"id":"63565","name":"Agenda - Industry Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-06-11T13:36:52Z","last_updated_date":"2024-06-11T13:36:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-industry-update-webinar-regulatory-procedure-management-product-lifecycle-management-iris_en.pdf"},
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    {"id":"63570","name":"Agenda - Quality Innovation Group (QIG) Listen and Learn Focus Group (LLFG) meeting on Process Models","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-06-11T14:00:19Z","last_updated_date":"2024-06-11T14:00:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-quality-innovation-group-qig-listen-learn-focus-group-llfg-meeting-process-models_en.pdf"},
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    {"id":"63578","name":"Ramipril : List of nationally authorised medicinal products - PSUSA/00002607/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-12T10:45:20Z","last_updated_date":"2024-06-12T10:45:20Z","reference_number":"EMA/274921/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ramipril-list-nationally-authorised-medicinal-products-psusa-00002607-202308_en.pdf"},
    {"id":"63216","name":"Agenda - Quarterly System Demo Q2 2024","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-05-16T10:46:00Z","last_updated_date":"2024-06-12T13:26:00Z","reference_number":"EMA/152799/2024 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-quarterly-system-demo-q2-2024_en.pdf"},
    {"id":"63590","name":"Agenda - Biannual Big Data Steering Group and industry stakeholders meeting 2024","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-06-12T16:20:00Z","last_updated_date":"2024-06-12T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-biannual-big-data-steering-group-industry-stakeholders-meeting-2024_en.pdf"},
    {"id":"63591","name":"Summary report -  - Biannual Big Data Steering Group and industry stakeholders meeting 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2024-06-12T16:20:00Z","last_updated_date":"2024-06-12T16:20:00Z","reference_number":"EMA/255630/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/summary-report-biannual-big-data-steering-group-industry-stakeholders-meeting-2024_en.pdf"},
    {"id":"63572","name":"Executive summary for proposed amendments to the European Commission guidelines on variations categories and procedures","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-06-13T09:43:00Z","last_updated_date":"2024-06-13T09:43:00Z","reference_number":"EMA/269251/2024","document_url":"https://www.ema.europa.eu/en/documents/other/executive-summary-proposed-amendments-european-commission-guidelines-variations-categories-procedures_en.pdf"},
    {"id":"56930","name":"CVMP post-authorisation summary of positive opinion for NexGard (WS)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-12-09T14:50:00Z","last_updated_date":"2022-12-09T14:50:00Z","reference_number":"EMA/CVMP/924541/2022","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-nexgard-ws_en.pdf"},
    {"id":"56929","name":"CVMP post-authorisation summary of positive opinion for Nexgard Spectra (WS)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2022-12-09T14:48:00Z","last_updated_date":"2022-12-09T14:48:00Z","reference_number":"EMA/CVMP/924541/2022 ","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-nexgard-spectra-ws_en.pdf"},
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    {"id":"63677","name":"Direct healthcare professional communication (DHPC) : Zypadhera (olanzapine pamoate monohydrate): Injection kits to temporarily include only three 38 mm safety needles instead of two 38 mm and two 50 mm safety needles","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-06-19T11:18:00Z","last_updated_date":"2024-06-19T11:18:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-zypadhera-olanzapine-pamoate-monohydrate-injection-kits-temporarily-include-only-three-38-mm-safety-needles-instead-two-38-mm-two-50-mm-safety-needles_en.pdf"},
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    {"id":"56135","name":"Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2022-09-19T10:21:00Z","last_updated_date":"2023-04-26T18:00:00Z","reference_number":"EMA/627319/2022","document_url":"https://www.ema.europa.eu/en/documents/public-statement/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf"},
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    {"id":"48861","name":"EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2020-09-18T12:00:00Z","last_updated_date":"2020-09-18T12:00:00Z","reference_number":"EMA/483739/2020","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/ema-endorses-use-dexamethasone-covid-19-patients-oxygen-or-mechanical-ventilation_en.pdf"},
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    {"id":"48846","name":"Dexamethasone - COVID19 - Article-5(3) procedure: proposals for product information","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2020-09-18T12:00:00Z","last_updated_date":"2020-09-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/dexamethasone-covid19-article-53-procedure-proposals-product-information_en.pdf"},
    {"id":"50220","name":"European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2021-02-19T15:04:00Z","last_updated_date":"2021-02-22T09:54:00Z","reference_number":"EMA/425645/2020","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/european-medicines-regulatory-network-approach-implementation-chmp-opinion-pursuant-article-53-regulation-ec-no-726-2004-nitrosamine-impurities-human-medicines_en.pdf"},
    {"id":"45526","name":"Nitrosamine impurities - Interim outcome of Article 5(3)","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2019-09-26T12:00:00Z","last_updated_date":"2019-09-26T12:00:00Z","reference_number":"EMA/511347/2019","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamine-impurities-interim-outcome-article-53_en.pdf"},
    {"id":"48272","name":"Nitrosamine impurities - Final outcome of Article 5(3)","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2020-07-09T14:00:00Z","last_updated_date":"2020-07-09T14:00:00Z","reference_number":"EMA/341963/2020","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamine-impurities-final-outcome-article-53_en.pdf"},
    {"id":"45521","name":"Nitrosamines EMEA-H-A5(3)-1490 - Information on nitrosamines for marketing authorisation holders - Obsolete","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2019-09-26T12:00:00Z","last_updated_date":"2019-09-26T12:00:00Z","reference_number":"EMA/189634/2019","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamines-emea-h-a53-1490-information-nitrosamines-marketing-authorisation-holders-obsolete_en.pdf"},
    {"id":"48273","name":"Nitrosamines EMEA-H-A5(3)-1490 - Assessment report","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2020-07-09T14:00:00Z","last_updated_date":"2020-07-09T14:00:00Z","reference_number":"EMA/369136/2020","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamines-emea-h-a53-1490-assessment-report_en.pdf"},
    {"id":"45522","name":"Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers on 'Information on nitrosamines for marketing authorisation holders' - Obsolete","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2019-09-26T12:00:00Z","last_updated_date":"2020-03-27T17:05:00Z","reference_number":"EMA/CHMP/428592/2019 Rev. 3","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamines-emea-h-a53-1490-questions-answers-information-nitrosamines-marketing-authorisation-holders-obsolete_en.pdf"},
    {"id":"45441","name":"EMA to provide guidance on avoiding nitrosamines in human medicines","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2019-09-13T14:00:00Z","last_updated_date":"2019-09-13T14:00:00Z","reference_number":"EMA/500009/2019","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/ema-provide-guidance-avoiding-nitrosamines-human-medicines_en.pdf"},
    {"id":"47493","name":"Assessment report for Article-5(3) procedure: direct oral anticoagulants (DOACs)","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2020-04-28T10:25:00Z","last_updated_date":"2020-04-28T10:25:00Z","reference_number":"EMA/194375/2020","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-direct-oral-anticoagulants-doacs_en.pdf"},
    {"id":"43607","name":"Direct oral anticoagulants (DOACs) - EMA starts review of study on bleeding risk with direct oral anticoagulants","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2019-02-01T12:00:00Z","last_updated_date":"2019-02-01T12:00:00Z","reference_number":"EMA/37941/2019","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/direct-oral-anticoagulants-doacs-ema-starts-review-study-bleeding-risk-direct-oral-anticoagulants_en.pdf"},
    {"id":"47195","name":"No change is needed in use of direct oral anticoagulants following EMA-funded study","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2020-03-27T12:00:00Z","last_updated_date":"2020-03-27T12:00:00Z","reference_number":"EMA/94424/2020","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/no-change-needed-use-direct-oral-anticoagulants-following-ema-funded-study_en.pdf"},
    {"id":"42896","name":"Assessment report for Article-5(3) procedure: Gentamicin","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2018-12-03T11:43:00Z","last_updated_date":"2018-12-03T11:43:00Z","reference_number":"EMA/805330/201","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-gentamicin_en.pdf"},
    {"id":"44428","name":"Assessment report for Article-5(3) procedure: norethisterone and ethinylestradiol (EMEA/H/A-5(3)/1477)","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2019-05-06T10:26:00Z","last_updated_date":"2019-05-24T10:04:00Z","reference_number":"EMA/245512/2019 Corr.","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-norethisterone-ethinylestradiol-emea-h-53-1477_en.pdf"},
    {"id":"42442","name":"Assessment report for Article-5(3) procedure: norethisterone and ethinylestradiol","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2018-10-26T16:15:00Z","last_updated_date":"2018-10-26T16:15:00Z","reference_number":"EMA/745160/2018","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-norethisterone-ethinylestradiol_en.pdf"},
    {"id":"11628","name":"Assessment report for Article-5(3) procedure: desloratadine-containing medicinal products","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2017-07-10T16:10:00Z","last_updated_date":"2019-02-25T16:10:00Z","reference_number":"EMA/421768/2017","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-desloratadine-containing-medicinal-products_en.pdf"},
    {"id":"17039","name":"Assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2016-03-14T14:10:00Z","last_updated_date":"2016-03-14T14:10:00Z","reference_number":"EMA/129754/2016","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-medicinal-products-under-development-treatment-ebola_en.pdf"},
    {"id":"37378","name":"Interim assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2014-12-16T11:00:00Z","last_updated_date":"2015-02-02T16:15:00Z","reference_number":"EMA/756544/2014 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/interim-assessment-report-article-53-procedure-medicinal-products-under-development-treatment-ebola_en.pdf"},
    {"id":"33944","name":"Assessment report for Article-5(3) procedure: Propylene glycol in medicinal products for children","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2014-03-27T16:00:00Z","last_updated_date":"2014-03-27T16:00:00Z","reference_number":"EMA/175205/2014","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-propylene-glycol-medicinal-products-children_en.pdf"},
    {"id":"30601","name":"Assessment report for Article-5(3) procedure: GLP-1-based therapies","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2013-08-01T19:00:00Z","last_updated_date":"2013-08-01T19:00:00Z","reference_number":"EMA/474117/2013","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-glp-1-based-therapies_en.pdf"},
    {"id":"22970","name":"Assessment report for Article-5(3) procedure: Octagam and associated names","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2013-05-28T19:34:00Z","last_updated_date":"2013-05-28T19:34:00Z","reference_number":"EMA/227216/2012","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-octagam-associated-names_en.pdf"},
    {"id":"11756","name":"Assessment report for Article-5(3) procedure: Teicoplanin-containing medicinal products","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2013-04-22T12:00:00Z","last_updated_date":"2013-04-22T12:00:00Z","reference_number":"EMA/194668/2013","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-teicoplanin-containing-medicinal-products_en.pdf"},
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    {"id":"5829","name":"Assessment report for Article-5(3) procedure: Immunological differences of pandemic vaccines (review of hypothesis on Pandemrix and development of narcolepsy)","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2012-11-12T15:10:00Z","last_updated_date":"2012-11-12T15:10:00Z","reference_number":"EMA/687578/2012","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-immunological-differences-pandemic-vaccines-review-hypothesis-pandemrix-development-narcolepsy_en.pdf"},
    {"id":"22703","name":"Assessment report for Article-5(3) procedure: Non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular risk","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2012-11-12T15:11:00Z","last_updated_date":"2012-11-12T15:11:00Z","reference_number":"EMA/696137/2012","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-non-steroidal-anti-inflammatory-drugs-nsaids-cardiovascular-risk_en.pdf"},
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    {"id":"8959","name":"Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, for non-selective non-steroidal anti-inflammatory drugs (NSAIDs)","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2006-10-23T02:09:00Z","last_updated_date":"2006-10-23T02:09:00Z","reference_number":"EMEA/CHMP/410051/2006","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/opinion-chmp-pursuant-article-53-regulation-ec-no-726-2004-non-selective-non-steroidal-anti-inflammatory-drugs-nsaids_en.pdf"},
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    {"id":"3774","name":"Assessment report for Article-5(3) procedure: Angiotensin II (type-1) receptor antagonists and risk of cancer","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2012-02-09T12:30:00Z","last_updated_date":"2012-02-09T12:30:00Z","reference_number":"EMEA/H/A-5(3)/1274","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-angiotensin-ii-type-1-receptor-antagonists-risk-cancer_en.pdf"},
    {"id":"2879","name":"Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2011-10-20T19:00:00Z","last_updated_date":"2017-05-11T19:00:00Z","reference_number":"EMA/CHMP/834168/2011","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/questions-answers-review-angiotensin-ii-receptor-antagonists-risk-cancer_en.pdf"},
    {"id":"19598","name":"Assessment report under Article 5(3) for particles on silicone tubing of diphtheria and tetanus toxoid (DT) and diphtheria/tetanus toxoid/pertussis (DTwP) antigen bulk containers","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2011-10-10T02:00:00Z","last_updated_date":"2011-10-10T02:00:00Z","reference_number":"EMA/474456/2011","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-under-article-53-particles-silicone-tubing-diphtheria-tetanus-toxoid-dt-diphtheria-tetanus-toxoid-pertussis-dtwp-antigen-bulk-containers_en.pdf"},
    {"id":"29186","name":"Assessment report for celecoxib for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis, as an adjunct to surgery and further endoscopic surveillance","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2011-06-15T14:32:00Z","last_updated_date":"2011-06-15T14:32:00Z","reference_number":"EMA/416998/2011","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-celecoxib-reduction-number-adenomatous-intestinal-polyps-familial-adenomatous-polyposis-adjunct-surgery-further-endoscopic-surveillance_en.pdf"},
    {"id":"15341","name":"Confidentiality arrangement: Letter from EMA to the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Ageing","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-01T16:00:00Z","last_updated_date":"2012-10-01T16:00:00Z","reference_number":"EMEA/490079/2009","document_url":"https://www.ema.europa.eu/en/documents/other/confidentiality-arrangement-letter-ema-therapeutic-goods-administration-tga-australian-government-department-health-ageing_en.pdf"},
    {"id":"11645","name":"Confidentiality arrangement: Letter from the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Ageing to EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2012-10-01T16:00:00Z","last_updated_date":"2012-10-01T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/confidentiality-arrangement-letter-therapeutic-goods-administration-tga-australian-government-department-health-ageing-ema_en.pdf"},
    {"id":"5122","name":"Assessment report for Article-5(3) procedure: Presence of endotoxins in Baxter peritoneal dialysis solutions","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/833156/2010","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-presence-endotoxins-baxter-peritoneal-dialysis-solutions_en.pdf"},
    {"id":"16168","name":"Questions and answers on the presence of endotoxins in Baxter peritoneal dialysis solutions","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2010-12-17T01:00:00Z","last_updated_date":"2010-12-17T01:00:00Z","reference_number":"EMA/818936/2010","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/questions-answers-presence-endotoxins-baxter-peritoneal-dialysis-solutions_en.pdf"},
    {"id":"7674","name":"Assessment report for Article-5(3) procedure: Detection by a highly sensitive new polymerase-chain-reaction technique of genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines","type":"opinion-on-any-scientific-matter","status":"Adopted","consultation_date":"","first_published_date":"2012-02-09T01:00:00Z","last_updated_date":"2012-02-09T01:00:00Z","reference_number":"EMEA/H/A-5(3)/1269","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/assessment-report-article-53-procedure-detection-highly-sensitive-new-polymerase-chain-reaction-technique-genomic-fragments-endogenous-adventitious-viral-agents-live-attenuated-vaccines_en.pdf"},
    {"id":"5818","name":"Questions and answers on the detection of unexpected viral DNA in live attenuated vaccines","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2010-11-18T01:00:00Z","last_updated_date":"2010-11-18T01:00:00Z","reference_number":"EMA/718290/2010","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/questions-answers-detection-unexpected-viral-dna-live-attenuated-vaccines_en.pdf"},
    {"id":"15128","name":"Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on bisphosphonates and osteonecrosis of the jaw","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-10-08T02:09:00Z","last_updated_date":"2009-10-08T02:09:00Z","reference_number":"EMEA/CHMP/292474/2009, EMEA/H/A-5(3)/1130","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/opinion-chmp-pursuant-article-53-regulation-ec-no-726-2004-bisphosphonates-osteonecrosis-jaw_en.pdf"},
    {"id":"22204","name":"Request for a scientific opinion letter","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-10-08T02:09:00Z","last_updated_date":"2009-10-08T02:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/request-scientific-opinion-letter_en.pdf"},
    {"id":"7669","name":"Questions and answers on the review of bisphosphonates and the risk of osteonecrosis of the jaw","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:09:21Z","last_updated_date":"2009-09-24T02:09:21Z","reference_number":"EMEA/CHMP/292475/2009","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/questions-answers-review-bisphosphonates-risk-osteonecrosis-jaw_en.pdf"},
    {"id":"20210","name":"CHMP assessment report on bisphosphonates and osteonecrosis of the jaw - Procedure under Article 5(3) of Regulation (EC) No 726/2004","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-09-24T02:09:21Z","last_updated_date":"2009-09-24T02:09:21Z","reference_number":"EMEA/CHMP/291125/2009","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/chmp-assessment-report-bisphosphonates-osteonecrosis-jaw-procedure-under-article-53-regulation-ec-no-726-2004_en.pdf"},
    {"id":"36893","name":"Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) no 726/2004, on novel influenza (H1N1) outbreak, Tamiflu (oseltamivir), Relenza (zanamivir)","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-05-08T02:00:00Z","last_updated_date":"2009-05-08T02:00:00Z","reference_number":"EMEA/CHMP/278838/2009","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/opinion-chmp-pursuant-article-53-regulation-ec-no-726-2004-novel-influenza-h1n1-outbreak-tamiflu-oseltamivir-relenza-zanamivir_en.pdf"},
    {"id":"29235","name":"CHMP assessment report on novel influenza (H1N1) outbreak, Tamiflu (oseltamivir), Relenza (zanamivir)","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-05-07T02:00:00Z","last_updated_date":"2009-05-07T02:00:00Z","reference_number":"EMEA/CHMP/287662/2009","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/chmp-assessment-report-novel-influenza-h1n1-outbreak-tamiflu-oseltamivir-relenza-zanamivir_en.pdf"},
    {"id":"14964","name":"Questions and answers on the use of antiviral medicines in case of novel influenza A/H1N1 pandemic","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2009-05-08T02:00:00Z","last_updated_date":"2009-05-08T02:00:00Z","reference_number":"EMEA/273535/2009","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/questions-answers-use-antiviral-medicines-case-novel-influenza-h1n1-pandemic_en.pdf"},
    {"id":"32542","name":"Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on conventional antipsychotics","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2008-11-27T00:09:21Z","last_updated_date":"2008-11-27T00:09:21Z","reference_number":"EMEA/CHMP/590563/2008","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/opinion-chmp-pursuant-article-53-regulation-ec-no-726-2004-conventional-antipsychotics_en.pdf"},
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    {"id":"20332","name":"Letter on efficacy of antidepressants","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2008-03-19T00:09:00Z","last_updated_date":"2008-03-19T00:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/letter-efficacy-antidepressants_en.pdf"},
    {"id":"9120","name":"CHMP assessment report on antidepressants under Article 5(3) of Regulation (EC) No 726/2004","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:09:21Z","last_updated_date":"2008-05-30T02:09:21Z","reference_number":"EMEA/CHMP/266019/2008","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/chmp-assessment-report-antidepressants-under-article-53-regulation-ec-no-726-2004_en.pdf"},
    {"id":"33630","name":"Opinion of the CHMP pursuant to Article-5(3) of Regulation (EC) No 726/2004, on heparins","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2008-06-06T02:09:21Z","last_updated_date":"2008-06-06T02:09:21Z","reference_number":"EMEA/CHMP/271967/2008","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/opinion-chmp-pursuant-article-53-regulation-ec-no-726-2004-heparins_en.pdf"},
    {"id":"30866","name":"CHMP assessment report for medicinal products containing or derived from heparin under Article 5(3) of Regulation (EC) No 726/2004","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2008-05-30T02:09:21Z","last_updated_date":"2008-05-30T02:09:21Z","reference_number":"EMEA/CHMP/278280/2008","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/chmp-assessment-report-medicinal-products-containing-or-derived-heparin-under-article-53-regulation-ec-no-726-2004_en.pdf"},
    {"id":"13000","name":"Questions and answers on heparins","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2008-06-05T02:09:00Z","last_updated_date":"2008-06-05T02:09:00Z","reference_number":"EMEA/276814/2008","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/questions-answers-heparins_en.pdf"},
    {"id":"28413","name":"CHMP scientific Article-5(3) opinion on the potential risks of carcinogens, mutagens and substances toxic to reproduction when these substances are used as excipients of medicinal products for human use","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2007-10-18T02:00:00Z","last_updated_date":"2007-10-18T02:00:00Z","reference_number":"EMEA/CHMP/SWP/146166/2007","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/chmp-scientific-article-53-opinion-potential-risks-carcinogens-mutagens-substances-toxic-reproduction-when-these-substances-are-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"7107","name":"Adequacy of guidance on the elderly regarding medicinal products for human use","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2006-12-14T00:09:00Z","last_updated_date":"2006-12-14T00:09:00Z","reference_number":"EMEA/498920/2006","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/adequacy-guidance-elderly-regarding-medicinal-products-human-use_en.pdf"},
    {"id":"13503","name":"Letter on request for opinion on non-selective NSAIDs under Article 5(3) of Regulation (EC) No 726/2004","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2006-09-21T02:09:00Z","last_updated_date":"2006-09-21T02:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/letter-request-opinion-non-selective-nsaids-under-article-53-regulation-ec-no-726-2004_en.pdf"},
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    {"id":"63382","name":"2023 annual report of the European Medicines Agency","type":"annual-report","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T11:48:00Z","last_updated_date":"2024-07-05T12:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/annual-report/2023-annual-report-european-medicines-agency_en.pdf"},
    {"id":"63900","name":"Hydroxyprogesterone-containing medicinal products Article 31-referral - Public assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2024-07-05T13:36:58Z","last_updated_date":"2024-07-05T13:36:58Z","reference_number":"EMA/263875/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/hydroxyprogesterone-containing-medicinal-products-article-31-referral-public-assessment-report_en.pdf"},
    {"id":"63941","name":"Public statement on Skysona : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2024-07-08T09:32:00Z","last_updated_date":"2024-07-08T09:32:00Z","reference_number":"EMA/706673/2021","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-skysona-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"63952","name":"Presentation - New Fee Regulation: upcoming changes foreseen for R&D Procedures","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T08:52:12Z","last_updated_date":"2024-07-09T08:52:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-fee-regulation-upcoming-changes-foreseen-rd-procedures_en.pdf"},
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    {"id":"63954","name":"Presentation - Ad-hoc focus group on RWD & RWE (P.Verpillat, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T09:05:38Z","last_updated_date":"2024-07-09T09:05:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ad-hoc-focus-group-rwd-rwe-pverpillat-ema_en.pdf"},
    {"id":"63955","name":"Presentation - Update on the scientific publication (S.Aarum, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T09:06:55Z","last_updated_date":"2024-07-09T09:06:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-scientific-publication-saarum-ema_en.pdf"},
    {"id":"63956","name":"Agenda - Twelfth meeting of the industry stakeholder platform on research and development support","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2024-07-09T09:13:42Z","last_updated_date":"2024-07-09T09:13:42Z","reference_number":"EMA/174789/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-twelfth-meeting-industry-stakeholder-platform-research-development-support_en.pdf"},
    {"id":"63958","name":"Agenda - Fifth EMA-AESGP annual bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-04-26T09:29:26Z","last_updated_date":"2024-07-09T09:30:00Z","reference_number":"EMA/137738/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fifth-ema-aesgp-annual-bilateral-meeting_en.pdf"},
    {"id":"12937","name":"eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) user manual","type":"other","status":"unknown","consultation_date":"","first_published_date":"2014-01-31T18:00:00Z","last_updated_date":"2024-07-09T10:44:00Z","reference_number":"EMA/308954/2012 Version 5.9","document_url":"https://www.ema.europa.eu/en/documents/other/extended-eudravigilance-medicinal-product-dictionary-xevmpd-data-entry-tool-evweb-user-manual_en.pdf"},
    {"id":"63715","name":"Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 1 April 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-06-21T13:00:00Z","last_updated_date":"2024-06-21T13:00:00Z","reference_number":"EMA/MB/182939/2023","document_url":"https://www.ema.europa.eu/en/documents/other/rules-implementation-council-regulation-ec-no-297-95-fees-payable-european-medicines-agency-other-measures-revised-implementing-rules-fee-regulation-1-april-2024_en.pdf"},
    {"id":"63960","name":"Presentation - Current practices for communication and uptake of risk minimisation measures by healthcare professionals (O. Clément, ESR)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T13:50:29Z","last_updated_date":"2024-07-09T13:50:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-current-practices-communication-uptake-risk-minimisation-measures-healthcare-professionals-o-clement-esr_en.pdf"},
    {"id":"63970","name":"Presentation - Update on HCP POG drafting groups (I. Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T14:23:00Z","last_updated_date":"2024-07-09T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-hcp-pog-drafting-groups-i-silva-ema_en.pdf"},
    {"id":"63971","name":"Presentation - CHMP early dialogue with healthcare professional organisations (C. Henrot, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T14:57:00Z","last_updated_date":"2024-07-09T14:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmp-early-dialogue-healthcare-professional-organisations-c-henrot-ema_en.pdf"},
    {"id":"63983","name":"Agenda - Info session on web-based electronic Application Form (eAF) add package","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T17:47:19Z","last_updated_date":"2024-07-09T17:47:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-info-session-web-based-electronic-application-form-eaf-add-package_en.pdf"},
    {"id":"63052","name":"Small and medium-sized enterprise (SME) office annual report 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-04-26T11:18:00Z","last_updated_date":"2024-07-10T12:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/small-medium-sized-enterprise-sme-office-annual-report-2023_en.pdf"},
    {"id":"19216","name":"CHMP post authorisation summary of positive opinion for  Zevalin on 19 March 2008","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2008-03-30T01:00:00Z","last_updated_date":"2008-03-30T01:00:00Z","reference_number":"EMEA/CHMP/144112/2008","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zevalin-19-march-2008_en.pdf"},
    {"id":"63995","name":"Public statement on Zevalin: Cessation of validity of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T14:53:35Z","last_updated_date":"2024-07-10T14:53:35Z","reference_number":"EMA/226889/2024","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-zevalin-cessation-validity-marketing-authorisation-european-union_en.pdf"},
    {"id":"63819","name":"Agenda - Public webinar on pack size submissions: from XEVMPD to product management service (PMS)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-06-28T16:15:00Z","last_updated_date":"2024-07-10T15:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-public-webinar-pack-size-submissions-xevmpd-product-management-service-pms_en.pdf"},
    {"id":"59829","name":"Mandate, objectives and composition of Industry Standing Group (ISG)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-10-04T16:00:08Z","last_updated_date":"2024-07-10T16:10:00Z","reference_number":"EMA/52789/2022","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-composition-industry-standing-group-isg_en.pdf"},
    {"id":"32038","name":"CHMP summary of positive opinion for Pixuvri","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2012-02-17T01:00:00Z","last_updated_date":"2012-02-17T01:00:00Z","reference_number":"EMA/CHMP/102366/2012","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-pixuvri_en.pdf"},
    {"id":"63997","name":"Public statement on Pixuvri: Expiry of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T16:24:01Z","last_updated_date":"2024-07-10T16:24:01Z","reference_number":"EMA/272680/2024","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-pixuvri-expiry-marketing-authorisation-european-union_en.pdf"},
    {"id":"63323","name":"Record of data processing activity for Risk Management Plans Publication Process","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-05-24T15:50:00Z","last_updated_date":"2024-05-24T15:50:00Z","reference_number":"EMA/219343/2024","document_url":"https://www.ema.europa.eu/en/documents/other/record-data-processing-activity-risk-management-plans-publication-process_en.pdf"},
    {"id":"64002","name":"Presentation - European Shortages Monitoring Platform (ESMP) essentials and industry reporting requirements webinar","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T17:02:00Z","last_updated_date":"2024-07-10T17:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-shortages-monitoring-platform-esmp-essentials-industry-reporting-requirements-webinar_en.pdf"},
    {"id":"36809","name":"Standard operating procedure for arrangements for handling of conflicts of interests for European Medicines Agency scientific meetings","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2012-10-08T17:40:00Z","last_updated_date":"2024-07-11T10:48:00Z","reference_number":"EMA/508581/2012","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-arrangements-handling-conflicts-interests-european-medicines-agency-scientific-meetings_en.pdf"},
    {"id":"6923","name":"Standard operating procedure for evaluation of conflicts of interests of experts for involvement in Agency activities","type":"sop","status":"Adopted","consultation_date":"","first_published_date":"2006-08-22T02:00:00Z","last_updated_date":"2024-07-11T10:54:00Z","reference_number":"EMA/52293/2006","document_url":"https://www.ema.europa.eu/en/documents/sop/standard-operating-procedure-evaluation-conflicts-interests-experts-involvement-agency-activities_en.pdf"},
    {"id":"63895","name":"Presentation - Session 1 : Clinical impact of shortages (E. Woodward)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T12:48:00Z","last_updated_date":"2024-07-05T12:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-clinical-impact-shortages-e-woodward_en.pdf"},
    {"id":"63896","name":"Presentation - Session 1 : Clinical impact of shortages (F. Giorgino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T12:53:00Z","last_updated_date":"2024-07-05T12:53:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-clinical-impact-shortages-f-giorgino_en.pdf"},
    {"id":"63897","name":"Presentation - Session 1 : Overview of the supply situation of GLP-1 RAs (K. Kruttwig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T12:55:00Z","last_updated_date":"2024-07-05T12:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-overview-supply-situation-glp-1-ras-k-kruttwig_en.pdf"},
    {"id":"63898","name":"Presentation - Session 2 : Mitigation measures recommended by EMA/MSSG (K. Kruttwig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T12:58:00Z","last_updated_date":"2024-07-05T12:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-mitigation-measures-recommended-ema-mssg-k-kruttwig_en.pdf"},
    {"id":"63899","name":"Presentation - Session 2 : Sharing of good practice  - examples from a non-EU regulator (R. Kosko)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T13:00:00Z","last_updated_date":"2024-07-05T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-sharing-good-practice-examples-non-eu-regulator-r-kosko_en.pdf"},
    {"id":"63901","name":"Presentation - Session 2 : Sharing of good practice - examples from EUEEA countries (D. di Giorgio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T13:44:00Z","last_updated_date":"2024-07-05T13:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-sharing-good-practice-examples-eueea-countries-d-di-giorgio_en.pdf"},
    {"id":"63902","name":"Presentation - Session 2 : Sharing of good practice - examples from EUEEA countries (G. Wilhelmsen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T13:46:00Z","last_updated_date":"2024-07-05T13:46:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-sharing-good-practice-examples-eueea-countries-g-wilhelmsen_en.pdf"},
    {"id":"63903","name":"Presentation - Session 2 : Sharing of good practice - examples from EUEEA countries (J. Velik)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T13:48:00Z","last_updated_date":"2024-07-05T13:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-sharing-good-practice-examples-eueea-countries-j-velik_en.pdf"},
    {"id":"63904","name":"Presentation - Session 2 : Sharing of good practice - examples from EUEEA countries (S. Schotte)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T13:49:00Z","last_updated_date":"2024-07-05T13:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-sharing-good-practice-examples-eueea-countries-s-schotte_en.pdf"},
    {"id":"63905","name":"Presentation - Session 2 : Prevention and mitigation measures taken by companies (E. Mashaki Ceyhan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T13:54:00Z","last_updated_date":"2024-07-05T13:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-prevention-mitigation-measures-taken-companies-e-mashaki-ceyhan_en.pdf"},
    {"id":"63907","name":"Presentation - Session 2 : Prevention and mitigation measures taken by companies (E. Pegg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:04:00Z","last_updated_date":"2024-07-05T14:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-prevention-mitigation-measures-taken-companies-e-pegg_en.pdf"},
    {"id":"63908","name":"Presentation - Session 2 : Prevention and mitigation measures taken by companies (J. Westerbacka)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:07:00Z","last_updated_date":"2024-07-05T14:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-prevention-mitigation-measures-taken-companies-j-westerbacka_en.pdf"},
    {"id":"63909","name":"Presentation - Session 3 : Communication activities by EMAMSSG on shortages of GLP-1 RAs (J. Garcia Burgos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:19:00Z","last_updated_date":"2024-07-05T14:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-communication-activities-emamssg-shortages-glp-1-ras-j-garcia-burgos_en.pdf"},
    {"id":"63911","name":"Presentation - Session 3 : Role of patients and consumers’ healthcare professional organisations in supporting communication activities (E. Dupont)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:25:00Z","last_updated_date":"2024-07-05T14:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-role-patients-consumers-healthcare-professional-organisations-supporting-communication-activities-e-dupont_en.pdf"},
    {"id":"63914","name":"Presentation - Session 3 : The role of social media in shortages of GLP-1 RAs (A. Santos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:35:00Z","last_updated_date":"2024-07-05T14:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-role-social-media-shortages-glp-1-ras-santos_en.pdf"},
    {"id":"63917","name":"Presentation - Session 3 : Sharing of good practice - examples on communication from member states (Y. Knudsen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:40:00Z","last_updated_date":"2024-07-05T14:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-sharing-good-practice-examples-communication-member-states-y-knudsen_en.pdf"},
    {"id":"63918","name":"Presentation - Session 3 : Sharing of good practice - examples on communication from member states (D. Pernas Cabo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:44:00Z","last_updated_date":"2024-07-05T14:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-sharing-good-practice-examples-communication-member-states-d-pernas-cabo_en.pdf"},
    {"id":"64021","name":"Minutes of the Cancer Medicines Forum - May 2024","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T11:14:00Z","last_updated_date":"2024-07-11T11:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cancer-medicines-forum-may-2024_en.pdf"},
    {"id":"63636","name":"Annual activity report 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-06-14T17:09:00Z","last_updated_date":"2024-07-11T11:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/annual-activity-report-2023_en.pdf"},
    {"id":"64033","name":"Presentation - Update on the development of the European Shortages Monitoring Platform (ESMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T14:25:00Z","last_updated_date":"2024-07-11T14:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-development-european-shortages-monitoring-platform-esmp_en.pdf"},
    {"id":"64034","name":"Presentation - Regulatory / HTA interface under the HTA Regulation (HTAR)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T14:25:00Z","last_updated_date":"2024-07-11T14:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-hta-interface-under-hta-regulation-htar_en.pdf"},
    {"id":"64035","name":"Presentation - European Medicines Agencies Network Strategy update to 2028","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T14:30:00Z","last_updated_date":"2024-07-11T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-medicines-agencies-network-strategy-update-2028_en.pdf-0"},
    {"id":"64036","name":"Presentation - Revised CTIS transparency rules and new version of the public portal","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T14:30:00Z","last_updated_date":"2024-07-11T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revised-ctis-transparency-rules-new-version-public-portal_en.pdf"},
    {"id":"64038","name":"Presentation - Update on Network Portfolio activities","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T15:17:00Z","last_updated_date":"2024-07-11T15:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-network-portfolio-activities_en.pdf"},
    {"id":"64039","name":"Presentation - International collaboration to facilitate medicines availability global assessment / inspection pathways","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-11T15:19:00Z","last_updated_date":"2024-07-11T15:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-collaboration-facilitate-medicines-availability-global-assessment-inspection-pathways_en.pdf"},
    {"id":"63910","name":"Presentation - Session 3 : Role of patients and consumers’ / healthcare professional organisations in supporting communication activities (J. Bowman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:23:00Z","last_updated_date":"2024-07-05T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-role-patients-consumers-healthcare-professional-organisations-supporting-communication-activities-j-bowman_en.pdf"},
    {"id":"63912","name":"Presentation - Session 3 : Role of patients and consumers’ / healthcare professional organisations in supporting communication activities (F. Giorgino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:29:00Z","last_updated_date":"2024-07-05T14:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-role-patients-consumers-healthcare-professional-organisations-supporting-communication-activities-f-giorgino_en.pdf"},
    {"id":"63913","name":"Presentation - Session 3 : Sharing of good practice - examples on communication from a non-EU regulator (A. Lostracco)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:34:00Z","last_updated_date":"2024-07-05T14:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-sharing-good-practice-examples-communication-non-eu-regulator-lostracco_en.pdf"},
    {"id":"63644","name":"Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) Working Party meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-06-17T09:49:56Z","last_updated_date":"2024-06-17T09:49:56Z","reference_number":"EMA/187783/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-ema-patients-consumers-pcwp-working-party-meeting_en.pdf"},
    {"id":"62690","name":"CHMP summary of positive opinion for Dimethyl fumarate Mylan","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2024-03-22T17:33:00Z","last_updated_date":"2024-03-22T17:33:00Z","reference_number":"EMA/CHMP/107054/2024 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dimethyl-fumarate-mylan_en.pdf"},
    {"id":"64053","name":"Presentation - Data-driven approaches in health research & innovation (T.Dyląg, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:11:03Z","last_updated_date":"2024-07-12T10:11:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-driven-approaches-health-research-innovation-tdylag-ec_en.pdf"},
    {"id":"64054","name":"Presentation - Introduction to regulatory-grade causal inference (X.Garcia de Albeniz, RTI Health Solutions)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:13:12Z","last_updated_date":"2024-07-12T10:13:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-regulatory-grade-causal-inference-xgarcia-de-albeniz-rti-health-solutions_en.pdf"},
    {"id":"64055","name":"Presentation - RWD-derived external controls in regulatory context (E.Asikanius, FIMEA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:19:48Z","last_updated_date":"2024-07-12T10:19:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-derived-external-controls-regulatory-context-easikanius-fimea_en.pdf"},
    {"id":"64056","name":"Presentation - Use of estimands in target trial emulation (J.Abellan, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:20:54Z","last_updated_date":"2024-07-12T10:20:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-estimands-target-trial-emulation-jabellan-ema_en.pdf"},
    {"id":"64057","name":"Presentation - The use of RWD derived External Control Arm to assess the Benefit of New Therapies (M.Feudjo Tepie, UCB)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:22:08Z","last_updated_date":"2024-07-12T10:22:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-rwd-derived-external-control-arm-assess-benefit-new-therapies-mfeudjo-tepie-ucb_en.pdf"},
    {"id":"64059","name":"Presentation - Externally controlled trials in oncology (D.Rivera, US FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:24:49Z","last_updated_date":"2024-07-12T10:24:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-externally-controlled-trials-oncology-drivera-us-fda_en.pdf"},
    {"id":"64060","name":"Presentation - Target trial and estimand in post-market safety studies (R.Izem, Novartis Pharma AG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:25:42Z","last_updated_date":"2024-07-12T10:25:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-target-trial-estimand-post-market-safety-studies-rizem-novartis-pharma-ag_en.pdf"},
    {"id":"64061","name":"Presentation - RWD-derived external controls case study: Abecma (A.Buzzi, T.Framke, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:26:53Z","last_updated_date":"2024-07-12T10:26:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-derived-external-controls-case-study-abecma-abuzzi-tframke-ema_en.pdf"},
    {"id":"64062","name":"Presentation - Use of real-world data in non-interventional studies to generate real-world evidence: Draft reflection paper (X.Kurz, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:31:47Z","last_updated_date":"2024-07-12T10:31:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-real-world-data-non-interventional-studies-generate-real-world-evidence-draft-reflection-paper-xkurz-ema_en.pdf"},
    {"id":"64063","name":"Presentation - Regulatory perspectives on TTE for pharmacovigilance (R.Fitzgerald, HPRA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:32:41Z","last_updated_date":"2024-07-12T10:32:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-perspectives-tte-pharmacovigilance-rfitzgerald-hpra_en.pdf"},
    {"id":"64064","name":"Presentation - Introduction to the Methodology Working Party (K.Roes, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:34:00Z","last_updated_date":"2024-07-12T10:34:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-methodology-working-party-kroes-ema_en.pdf"},
    {"id":"64065","name":"Presentation - MWP Roadmap for the development of RWE guidance (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:34:48Z","last_updated_date":"2024-07-12T10:34:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mwp-roadmap-development-rwe-guidance-ema_en.pdf"},
    {"id":"64066","name":"Presentation - The next three years: roadmap for RWE guidance (M.Schoonen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:35:27Z","last_updated_date":"2024-07-12T10:35:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-next-three-years-roadmap-rwe-guidance-mschoonen_en.pdf"},
    {"id":"64067","name":"Presentation - EMA Reflection paper on use of Real-World Data in Non-interventional Studies to Generate Real-World Evidence (A.Spooner, EFPIA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:36:19Z","last_updated_date":"2024-07-12T10:36:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-aspooner-efpia_en.pdf"},
    {"id":"64068","name":"Presentation - Joint HMA/EMA Big Data Steering Group Workshop on RWE methods Harnessing Real-World Data for Regulatory Use (P.Verpillat, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T10:37:26Z","last_updated_date":"2024-07-12T10:37:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-hma-ema-big-data-steering-group-workshop-rwe-methods-harnessing-real-world-data-regulatory-use-pverpillat-ema_en.pdf"},
    {"id":"64070","name":"PRAC statistics: July 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T11:43:00Z","last_updated_date":"2024-07-12T11:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/prac-statistics-july-2024_en.pdf"},
    {"id":"64082","name":"Acitretin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"64092","name":"Presentation - HMA/EMA task force on availability of authorised medicines (I. Abed, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T14:45:00Z","last_updated_date":"2024-07-12T14:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hma-ema-task-force-availability-authorised-medicines-i-abed-ema_en.pdf"},
    {"id":"64093","name":"Presentation - Joint HMA/EMA big data steering group on real-world evidence (RWE) methods (Klaus Kruttwig, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T14:48:00Z","last_updated_date":"2024-07-12T14:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-hma-ema-big-data-steering-group-real-world-evidence-rwe-methods-klaus-kruttwig-ema_en.pdf"},
    {"id":"64094","name":"Presentation - HMA/EMA task force on availability of authorised medicines (J. Ferreira, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T14:54:00Z","last_updated_date":"2024-07-12T14:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hma-ema-task-force-availability-authorised-medicines-j-ferreira-ema_en.pdf"},
    {"id":"64100","name":"Presentation - EMA’s vaccines outreach strategy (M. Cavaleri, M. Carr, EMA) ","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T15:07:00Z","last_updated_date":"2024-07-12T15:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-vaccines-outreach-strategy-m-cavaleri-m-carr-ema_en.pdf"},
    {"id":"64101","name":"Presentation - European vaccination information portal (EVIP) (N. White, ECDC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T15:11:00Z","last_updated_date":"2024-07-12T15:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-vaccination-information-portal-evip-n-white-ecdc_en.pdf"},
    {"id":"64102","name":"Presentation - EU vaccine monitoring platform what is it, and how can it inform HCPs, patients, and the public, on the benefit/risk of vaccines (C. Cohet, A. Buoninfante, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T15:20:00Z","last_updated_date":"2024-07-12T15:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-vaccine-monitoring-platform-what-it-how-can-it-inform-hcps-patients-public-benefit-risk-vaccines-c-cohet-buoninfante-ema_en.pdf"},
    {"id":"12234","name":"Superseded final Community herbal monograph on Panax ginseng C.A. Meyer, radix","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-05-22T02:00:00Z","last_updated_date":"2024-07-12T12:36:00Z","reference_number":"EMA/HMPC/321233/2012 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-community-herbal-monograph-panax-ginseng-ca-meyer-radix_en.pdf"},
    {"id":"18661","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Panax ginseng C.A.Meyer, radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-10-10T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/270952/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-panax-ginseng-cameyer-radix_en.pdf"},
    {"id":"38086","name":"Superseded final assessment report on Panax ginseng C.A. Meyer, radix","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-05-22T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/321232/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-final-assessment-report-panax-ginseng-ca-meyer-radix_en.pdf"},
    {"id":"27779","name":"Superseded final list of references supporting the assessment of Panax ginseng C.A. Meyer, radix","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-05-22T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/321234/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-references-supporting-assessment-panax-ginseng-ca-meyer-radix_en.pdf"},
    {"id":"41930","name":"Superseded final overview of comments received on draft Community herbal monograph on Panax ginseng C.A. Meyer, radix","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2014-05-22T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/679424/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-final-overview-comments-received-draft-community-herbal-monograph-panax-ginseng-ca-meyer-radix_en.pdf"},
    {"id":"64108","name":"Final list of references supporting the assessment of Panax ginseng C.A.Mey., radix - Revision 1","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T15:41:00Z","last_updated_date":"2024-07-12T15:41:00Z","reference_number":"EMA/HMPC/27746/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-panax-ginseng-camey-radix-revision-1_en.pdf"},
    {"id":"64110","name":"Final assessment report on Panax ginseng C.A.Mey., radix - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2024-07-12T15:44:00Z","last_updated_date":"2024-07-12T15:44:00Z","reference_number":"EMA/HMPC/27745/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-panax-ginseng-camey-radix-revision-1_en.pdf"},
    {"id":"64113","name":"Final European Union herbal monograph on Panax ginseng C.A.Mey., radix - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2024-07-12T15:48:00Z","last_updated_date":"2024-07-12T15:48:00Z","reference_number":"EMA/HMPC/27744/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-panax-ginseng-camey-radix-revision-1_en.pdf"},
    {"id":"64111","name":"Opinion of the HMPC on a European Union herbal monograph on Panax ginseng C.A.Mey., radix","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2024-07-12T15:46:00Z","last_updated_date":"2024-07-12T15:46:00Z","reference_number":"EMA/HMPC/289958/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-panax-ginseng-camey-radix_en.pdf"},
    {"id":"28037","name":"Superseded final European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2018-08-20T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/444244/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-final-european-union-herbal-monograph-pelargonium-sidoides-dc-or-pelargonium-reniforme-curt-radix-revision-1_en.pdf"},
    {"id":"33104","name":"Superseded opinion of the HMPC on a European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2018-08-20T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/378804/2018","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-european-union-herbal-monograph-pelargonium-sidoides-dc-or-pelargonium-reniforme-curt-radix-revision-1_en.pdf"},
    {"id":"25376","name":"Superseded final assessment report on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2018-08-20T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/444251/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/superseded-final-assessment-report-pelargonium-sidoides-dc-or-pelargonium-reniforme-curt-radix-revision-1_en.pdf"},
    {"id":"27678","name":"Superseded final list of references supporting the assessment of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2018-08-20T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/444243/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/superseded-final-list-references-supporting-assessment-pelargonium-sidoides-dc-or-pelargonium-reniforme-curt-radix-revision-1_en.pdf"},
    {"id":"28185","name":"Superseded final overview of comments received on European Union herbal monograph on Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix - Revision 1","type":"herbal-comments","status":"Adopted","consultation_date":"","first_published_date":"2018-08-20T02:00:00Z","last_updated_date":"2024-07-12T02:00:00Z","reference_number":"EMA/HMPC/444243/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-final-overview-comments-received-european-union-herbal-monograph-pelargonium-sidoides-dc-or-pelargonium-reniforme-curt-radix-revision-1_en.pdf"},
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    {"id":"55893","name":"Final assessment report on Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum - Revision 1","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T10:54:00Z","last_updated_date":"2024-07-18T15:37:00Z","reference_number":"EMA/HMPC/271394/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-foeniculum-vulgare-miller-subsp-vulgare-var-vulgare-aetheroleum-revision-1_en.pdf"},
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    {"id":"26059","name":"Superseded opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. vulgare, aetheroleum","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2007-07-05T02:00:00Z","last_updated_date":"2024-07-19T02:00:00Z","reference_number":"EMEA/HMPC/280059/2007","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-committee-herbal-medicinal-products-community-herbal-monograph-foeniculum-vulgare-miller-subsp-vulgare-var-vulgare-aetheroleum_en.pdf"},
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    {"id":"54301","name":"Agenda of the PDCO meeting 22-25 February 2022","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2022-02-25T11:29:00Z","last_updated_date":"2022-02-25T11:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-meeting-22-25-february-2022_en.pdf"},
    {"id":"62249","name":"Valproate : PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0043","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-02-21T17:36:59Z","last_updated_date":"2024-07-24T11:31:00Z","reference_number":"EMA/334781/2024","document_url":"https://www.ema.europa.eu/en/documents/other/valproate-prac-non-interventional-imposed-pass-final-study-report-assessment-report-emea-h-n-psr-j-0043_en.pdf"},
    {"id":"64298","name":"Presentation - Target trial emulation in a DARWIN EU vaccine effectiveness study (Dani Prieto-Alhambra, DARWIN EU)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-24T11:11:11Z","last_updated_date":"2024-07-24T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-target-trial-emulation-darwin-eu-vaccine-effectiveness-study-dani-prieto-alhambra-darwin-eu_en.pdf"},
    {"id":"64299","name":"Presentation - Externally controlled trials in oncology (Donna Rivera, FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-07-24T11:11:01Z","last_updated_date":"2024-07-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-externally-controlled-trials-oncology-donna-rivera-fda_en.pdf"},
    {"id":"64301","name":"Direct healthcare professional communication (DHPC) : Vabysmo (faricimab): tear in primary packaging of transfer filter needle (TFN) co-packaged with vial","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-07-25T09:05:00Z","last_updated_date":"2024-07-25T09:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vabysmo-faricimab-tear-primary-packaging-transfer-filter-needle-tfn-co-packaged-vial_en.pdf"},
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    {"id":"63316","name":"Agenda - Seventh  European Medicines Agency - Medicines for Europe annual bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-05-24T09:42:47Z","last_updated_date":"2024-05-24T09:42:47Z","reference_number":"EMA/164965/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-seventh-european-medicines-agency-medicines-europe-annual-bilateral-meeting_en.pdf"},
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    {"id":"62167","name":"Call for scientific data for the periodic review of the monograph on Ribis nigri folium","type":"herbal-call-data","status":"Draft: consultation closed","consultation_date":"2024-02-15 - 2024-05-15","first_published_date":"2024-02-15T09:01:13Z","last_updated_date":"2024-02-15T09:01:13Z","reference_number":"EMA/HMPC/63202/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-call-data/call-scientific-data-periodic-review-monograph-ribis-nigri-folium_en.pdf"},
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    {"id":"62382","name":"Preliminary QIG Considerations regarding Pharmaceutical Process Models","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2024-02-29 - 2024-03-29","first_published_date":"2024-02-29T17:07:47Z","last_updated_date":"2024-02-29T17:07:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/preliminary-qig-considerations-regarding-pharmaceutical-process-models_en.pdf"},
    {"id":"62396","name":"VICH GL22(R) - Studies to evaluate the safety of residues of veterinary drugs in human food reproduction testing (Revision 1)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2024-02-15 - 2024-07-31","first_published_date":"2024-03-01T12:29:37Z","last_updated_date":"2024-03-01T12:29:37Z","reference_number":"EMA/CVMP/VICH/525/2000","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl22r-studies-evaluate-safety-residues-veterinary-drugs-human-food-reproduction-testing-revision-1_en.pdf"},
    {"id":"62411","name":"ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2024-02-22 - 2024-06-22","first_published_date":"2024-03-01T16:36:07Z","last_updated_date":"2024-03-01T16:36:07Z","reference_number":"EMA/CHMP/ICH/59123/20241","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e2dr1-guideline-post-approval-safety-data-step-2b-revision-1_en.pdf"},
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    {"id":"64927","name":"CHMP post-authorisation summary of positive opinion for Darzalex (II-72)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T10:47:53Z","last_updated_date":"2024-09-20T10:47:53Z","reference_number":"EMA/CHMP/410979/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-ii-72_en.pdf"},
    {"id":"64966","name":"CHMP post-authorisation summary of positive opinion for Pravafenix (II-37)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:08:07Z","last_updated_date":"2024-09-20T11:08:07Z","reference_number":"EMA/CHMP/423595/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-pravafenix-ii-37_en.pdf"},
    {"id":"64904","name":"CHMP post-authorisation summary of positive opinion for Dupixent (II-81)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T15:12:44Z","last_updated_date":"2024-09-20T15:12:44Z","reference_number":"EMA/CHMP/247127/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-dupixent-ii-81_en.pdf"},
    {"id":"64940","name":"CHMP post-authorisation summary of positive opinion for Fasenra (II-52)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T14:54:21Z","last_updated_date":"2024-09-20T14:54:21Z","reference_number":"EMA/422937/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-fasenra-ii-52_en.pdf"},
    {"id":"64896","name":"CHMP summary of positive opinion for Opuviz","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:43:20Z","last_updated_date":"2024-09-20T11:43:20Z","reference_number":"EMA/364707/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-opuviz_en.pdf"},
    {"id":"64980","name":"CHMP summary of positive opinion for Hympavzi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:11:01Z","last_updated_date":"2024-09-20T11:11:01Z","reference_number":"EMA/423564/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hympavzi_en.pdf"},
    {"id":"64965","name":"CHMP post-authorisation summary of positive opinion for Synjardy  (II-78)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:04:01Z","last_updated_date":"2024-09-20T11:04:01Z","reference_number":"EMA/CHMP/423614/2024 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-synjardy-ii-78_en.pdf"},
    {"id":"64930","name":"CHMP summary of opinion for Pomalidomide Teva","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T10:56:26Z","last_updated_date":"2024-09-20T10:56:26Z","reference_number":"EMA/CHMP/377627/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-opinion-pomalidomide-teva_en.pdf"},
    {"id":"64957","name":"Withdrawal letter: Durysta","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T11:11:01Z","last_updated_date":"2024-09-20T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-durysta_en.pdf"},
    {"id":"64962","name":"Questions and answers on the withdrawal of application to change the marketing authorisation for Sialanar (glycopyrronium bromide)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T10:31:24Z","last_updated_date":"2024-09-20T10:31:24Z","reference_number":"EMA/429177/2024","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-sialanar-glycopyrronium-bromide_en.pdf"},
    {"id":"64959","name":"Withdrawal letter: Sialanar (II-29)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T09:59:31Z","last_updated_date":"2024-09-20T09:59:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-sialanar-ii-29_en.pdf"},
    {"id":"64949","name":"CHMP post-authorisation summary of positive opinion for Buccolam (II-61)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T17:55:43Z","last_updated_date":"2024-09-20T17:55:43Z","reference_number":"EMA/CHMP/427451/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-buccolam-ii-61_en.pdf"},
    {"id":"64969","name":"CHMP post-authorisation summary of positive opinion for Zavicefta (II-35)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:58:35Z","last_updated_date":"2024-09-20T11:58:35Z","reference_number":"EMA/CHMP/429747/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zavicefta-ii-35_en.pdf"},
    {"id":"64950","name":"CHMP post-authorisation summary of positive opinion for Esperoct (II-23)","type":"smop","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T12:06:29Z","last_updated_date":"2024-09-20T12:06:29Z","reference_number":"EMA/423647/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-esperoct-ii-23_en.pdf"},
    {"id":"64929","name":"CHMP post-authorisation summary of positive opinion for Otezla (II-44-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T10:51:28Z","last_updated_date":"2024-09-20T10:51:28Z","reference_number":"EMA/CHMP/416713/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-otezla-ii-44-g_en.pdf"},
    {"id":"64925","name":"CHMP post-authorisation summary of positive opinion for Aflunov (II-86)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T10:41:56Z","last_updated_date":"2024-09-20T10:41:56Z","reference_number":"EMA/CHMP/435295/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-aflunov-ii-86_en.pdf"},
    {"id":"64909","name":"CHMP summary of positive opinion for Theralugand","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:11:01Z","last_updated_date":"2024-09-20T11:11:01Z","reference_number":"EMA/CHMP/417097/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-theralugand_en.pdf"},
    {"id":"64907","name":"CHMP summary of positive opinion for Elahere","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:11:01Z","last_updated_date":"2024-09-20T11:11:01Z","reference_number":"EMA/CHMP/415249/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-elahere_en.pdf"},
    {"id":"64982","name":"CHMP summary of positive opinion for Hetronifly","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T13:40:00Z","last_updated_date":"2024-09-20T13:40:00Z","reference_number":"EMA/CHMP/424207/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-hetronifly_en.pdf"},
    {"id":"64972","name":"CHMP post-authorisation summary of positive opinion for Keytruda (II-145)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T13:00:00Z","last_updated_date":"2024-09-20T13:00:00Z","reference_number":"EMA/CHMP/417252/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-145_en.pdf"},
    {"id":"64981","name":"Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T11:11:01Z","last_updated_date":"2024-09-20T11:11:01Z","reference_number":"EMA/CVMP/52665/2020 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-efficacy-target-animal-safety-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019-6-revision_en.pdf"},
    {"id":"64154","name":"Agenda - Joint HMA/EMA multi-stakeholder workshop on submission predictability","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-07-15T11:47:20Z","last_updated_date":"2024-09-20T15:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-joint-hma-ema-multi-stakeholder-workshop-submission-predictability_en.pdf"},
    {"id":"63783","name":"Questions and answers on the refusal of the marketing authorisation for Syfovre","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-06-28T12:00:00Z","last_updated_date":"2024-09-19T11:11:01Z","reference_number":"EMA/432931/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-syfovre_en.pdf"},
    {"id":"64864","name":" Presentation - Session 1: Mapping the landscape (S.Strasser)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-09-16T14:50:13Z","last_updated_date":"2024-09-20T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-mapping-landscape-sstrasser_en.pdf"},
    {"id":"64862","name":"Presentation - Session 2: Issue list and proposals for solutions (C.Bahans, E.Stahl, AM.Janson Lang, J.Bryant)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-09-16T14:48:51Z","last_updated_date":"2024-09-16T14:48:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-issue-list-proposals-solutions-cbahans-estahl-amjanson-lang-jbryant_en.pdf"},
    {"id":"64865","name":"Presentation - CTR collaborate project: Setting the scene (M.Lunzer, M.Al)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-09-16T14:50:57Z","last_updated_date":"2024-09-20T22:22:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ctr-collaborate-project-setting-scene-mlunzer-mal_en.pdf"},
    {"id":"64983","name":"CHMP post-authorisation summary of positive opinion for Keytruda (II-153)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T15:20:00Z","last_updated_date":"2024-09-20T15:20:00Z","reference_number":"EMA/CHMP/413921/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-keytruda-ii-153_en.pdf"},
    {"id":"64960","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Tecentriq (II-81)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T09:54:40Z","last_updated_date":"2024-09-20T09:54:40Z","reference_number":"EMA/426039/2024","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-tecentriq-ii-81_en.pdf"},
    {"id":"64986","name":"Minutes of the 124th meeting of the Management Board: 12-13 June 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2024-09-20T17:31:53Z","last_updated_date":"2024-09-20T17:31:53Z","reference_number":"EMA/MB/312765/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-124th-meeting-management-board-12-13-june-2024_en.pdf"},
    {"id":"64736","name":"Metamizole-containing medicinal products article 107i referral - EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole ","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T12:00:00Z","last_updated_date":"2024-09-06T12:00:00Z","reference_number":"EMA/407900/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107i-referral-ema-recommends-measures-minimise-serious-outcomes-known-side-effect-painkiller-metamizole_en.pdf"},
    {"id":"64951","name":"Metamizole-containing medicinal products article 107i referral - EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizole","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T12:00:00Z","last_updated_date":"2024-09-20T12:00:00Z","reference_number":"EMA/407900/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107i-referral-ema-recommends-measures-minimise-serious-outcomes-known-side-effect-painkiller-metamizole_en.pdf-0"},
    {"id":"63773","name":"CHMP summary of positive opinion for Winrevair","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-06-28T12:00:00Z","last_updated_date":"2024-06-28T12:00:00Z","reference_number":"EMA/CHMP/289588/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-winrevair_en.pdf"},
    {"id":"65034","name":"Presentation - EMA Account Management – What’s new?","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-09-25T13:23:00Z","last_updated_date":"2024-09-25T13:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-account-management-whats-new_en.pdf"},
    {"id":"5551","name":"Template for letter from marketing-authorisation holder (MAH) permitting the Agency to send certificates elsewhere than to MAH address","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2009-09-01T02:00:00Z","last_updated_date":"2024-09-25T14:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-letter-marketing-authorisation-holder-mah-permitting-agency-send-certificates-elsewhere-mah-address_en.doc"},
    {"id":"65035","name":"CTIS newsflash - 24 September 2024","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2024-09-25T14:20:00Z","last_updated_date":"2024-09-25T14:20:00Z","reference_number":"EMA/421508/2024","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-24-september-2024_en.pdf"},
    {"id":"65042","name":"Agenda of the Extraordinary CHMP meeting 26 September 2024","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-09-26T10:00:00Z","last_updated_date":"2024-09-26T10:00:00Z","reference_number":"EMA/CHMP/447920/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-extraordinary-chmp-meeting-26-september-2024_en.pdf"},
    {"id":"24178","name":"Superseded community herbal monograph on Rosmarinus officinalis L., folium","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2011-01-28T01:00:00Z","last_updated_date":"2024-09-26T01:00:00Z","reference_number":"EMA/HMPC/13633/2009","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-rosmarinus-officinalis-l-folium_en.pdf"},
    {"id":"26363","name":"Superseded opinion of the HMPC on a Community herbal monograph on Rosmarinus officinalis L., folium","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2011-02-03T01:00:00Z","last_updated_date":"2024-09-26T01:00:00Z","reference_number":"EMA/HMPC/457257/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/superseded-opinion-hmpc-community-herbal-monograph-rosmarinus-officinalis-l-folium_en.pdf"},
    {"id":"11173","name":"Superseded overview of comments received on Community herbal monograph on Rosmarinus officinalis L., folium","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2011-02-03T01:00:00Z","last_updated_date":"2024-09-26T01:00:00Z","reference_number":"EMA/HMPC/254082/2010","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/superseded-overview-comments-received-community-herbal-monograph-rosmarinus-officinalis-l-folium_en.pdf"},
    {"id":"57017","name":"Final European Union herbal monograph on Rosmarinus officinalis L., folium - Revision 1","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2022-12-15 - 2023-03-15","first_published_date":"2022-12-15T17:32:00Z","last_updated_date":"2024-09-26T12:43:00Z","reference_number":"EMA/HMPC/513940/2021","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-rosmarinus-officinalis-l-folium-revision-1_en.pdf"},
    {"id":"65044","name":"Final opinion of the HMPC on a European Union herbal monograph on Rosmarinus officinalis L., folium - Revision 1","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2024-09-26T12:46:00Z","last_updated_date":"2024-09-26T12:46:00Z","reference_number":"EMA/HMPC/317755/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/final-opinion-hmpc-european-union-herbal-monograph-rosmarinus-officinalis-l-folium-revision-1_en.pdf"},
    {"id":"65048","name":"Oxbryta Article-20 procedure - EMA starts review of sickle cell disease medicine Oxbryta","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2024-09-26T16:42:00Z","last_updated_date":"2024-09-26T16:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/oxbryta-article-20-procedure-ema-starts-review-sickle-cell-disease-medicine-oxbryta_en.pdf"},
    {"id":"65049","name":"Introduction to the Compilation of Union procedures on inspections and exchange of information","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2024-09-26T16:47:24Z","last_updated_date":"2024-09-26T16:47:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/introduction-compilation-union-procedures-inspections-exchange-information_en.pdf"},
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    {"id":"64701","name":"Agenda - Fourth veterinary big data stakeholder forum","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-09-04T15:46:58Z","last_updated_date":"2024-10-07T16:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-fourth-veterinary-big-data-stakeholder-forum_en.pdf"},
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    {"id":"65225","name":"Question & Answers: EMA Account Management, what’s new?","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-07T16:38:15Z","last_updated_date":"2024-10-07T16:38:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/question-answers-ema-account-management-whats-new_en.pdf"},
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    {"id":"63805","name":"Lorazepam Macure - Article 13 referral - Control of status epilepticus to be added to product information","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2024-06-28T12:00:00Z","last_updated_date":"2024-10-08T11:11:11Z","reference_number":"EMA/415192/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/lorazepam-macure-article-13-referral-control-status-epilepticus-be-added-product-information_sv.pdf"}},
    {"id":"65136","name":"Presentation - Pharmacogenetics implementation in the UK (M. Pirmohamed, D. Weatherall, University of Liverpool)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T15:42:00Z","last_updated_date":"2024-10-08T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pharmacogenetics-implementation-uk-m-pirmohamed-d-weatherall-university-liverpool_en.pdf"},
    {"id":"61087","name":"CHMP early contact with patient and healthcare professional organisations: process and FAQs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-11-28T16:12:20Z","last_updated_date":"2024-10-08T15:10:00Z","reference_number":"EMA/188551/2023 rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/chmp-early-contact-patient-healthcare-professional-organisations-process-faqs_en.pdf"},
    {"id":"65239","name":"Oxbryta Article-20 procedure - Assessment report on temporary measures","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2024-10-08T13:32:00Z","last_updated_date":"2024-10-08T13:32:00Z","reference_number":"EMA/460760/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/oxbryta-article-20-procedure-assessment-report-temporary-measures_en.pdf"},
    {"id":"65244","name":"Aprotinin : List of nationally authorised medicinal products - PSUSA/00000230/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T10:38:00Z","last_updated_date":"2024-10-09T10:38:00Z","reference_number":"EMA/470061/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/aprotinin-list-nationally-authorised-medicinal-products-psusa-00000230-202402_en.pdf"},
    {"id":"65245","name":"Iron dextran : List of nationally authorised medicinal products - PSUSA/00010696/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T11:25:00Z","last_updated_date":"2024-10-09T11:25:00Z","reference_number":"EMA/470113/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/iron-dextran-list-nationally-authorised-medicinal-products-psusa-00010696-202401_en.pdf"},
    {"id":"65243","name":"Towards the European medicines agencies network strategy 2028: Reflection paper","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T13:57:00Z","last_updated_date":"2024-10-09T13:57:00Z","reference_number":"EMA/297150/2024","document_url":"https://www.ema.europa.eu/en/documents/other/towards-european-medicines-agencies-network-strategy-2028-reflection-paper_en.pdf"},
    {"id":"63798","name":"CHMP summary of positive opinion for Enzalutamide Viatris","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-06-28T12:00:00Z","last_updated_date":"2024-06-28T12:00:00Z","reference_number":"EMA/270183/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-enzalutamide-viatris_en.pdf"},
    {"id":"65238","name":"Report - Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-10-08T13:27:15Z","last_updated_date":"2024-10-09T14:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-multistakeholder-workshop-shortages-glucagon-peptide-1-glp-1-receptor-agonists_en.pdf"},
    {"id":"65259","name":"European Union Member State Public Holidays Recorded in CTIS (year: 2025)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T16:03:03Z","last_updated_date":"2024-10-09T16:03:03Z","reference_number":"EMA/416959/2024","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-member-state-public-holidays-recorded-ctis-year-2025_en.pdf"},
    {"id":"65260","name":"Presentation - Product Management Service (XEVMPD) for Sponsors","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T16:40:07Z","last_updated_date":"2024-10-09T16:40:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-management-service-xevmpd-sponsors_en.pdf"},
    {"id":"63539","name":"Change management activities delivery plan - HMA-EMA joint Big Data Steering Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-06-07T15:34:50Z","last_updated_date":"2024-10-09T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/change-management-activities-delivery-plan-hma-ema-joint-big-data-steering-group_en.pdf"},
    {"id":"64754","name":"Agenda - Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution, evolution, revolution’","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T15:49:55Z","last_updated_date":"2024-10-09T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-scientific-symposium-advanced-therapy-medicinal-products-contribution-evolution-revolution_en.pdf"},
    {"id":"65262","name":"Direct healthcare professional communication (DHPC) : Synflorix: packaging issue potentially impacting the sterility of needle softpacks of Synflorix","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-10-10T10:00:00Z","last_updated_date":"2024-10-10T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-synflorix-packaging-issue-potentially-impacting-sterility-needle-softpacks-synflorix_en.pdf"},
    {"id":"65263","name":"Direct healthcare professional communication (DHPC) : Infanrix hexa Packaging issue potentially impacting the sterility of needle softpacks of Infanrix hexa","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-10-10T11:11:11Z","last_updated_date":"2024-10-10T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-infanrix-hexa-packaging-issue-potentially-impacting-sterility-needle-softpacks-infanrix-hexa_en.pdf"},
    {"id":"65264","name":"Overview of comments received on ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2024-10-10T11:52:00Z","last_updated_date":"2024-10-10T11:52:00Z","reference_number":"EMA/417650/2024","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-m14-guideline-general-principles-plan-design-analysis-pharmacoepidemiological-studies-utilize-real-world-data-safety-assessment-medicines_en.pdf"},
    {"id":"65273","name":"CTIS newsflash - 8 October 2024","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2024-10-10T15:32:15Z","last_updated_date":"2024-10-10T15:32:15Z","reference_number":"EMA/441928/2024","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-8-october-2024_en.pdf"},
    {"id":"59315","name":"European Medicines Agency Guidance for applicants seeking access to PRIME scheme","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2024-10-10T16:00:00Z","reference_number":"EMA/7872/2021","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-guidance-applicants-seeking-access-prime-scheme_en.pdf"},
    {"id":"37105","name":"PRIME – Paving the way for promising medicines for patients - Factsheet","type":"leaflet","status":"unknown","consultation_date":"","first_published_date":"2016-03-07T12:00:00Z","last_updated_date":"2024-10-10T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/leaflet/prime-paving-way-promising-medicines-patients-factsheet_en.pdf"},
    {"id":"64782","name":"Draft 3-year rolling work plan for the Rheumatology and Immunology Working Party (RIWP) : 2025-2027","type":"work-programme","status":"Draft: consultation closed","consultation_date":"2024-09-10 - 2024-10-10","first_published_date":"2024-09-10T16:34:24Z","last_updated_date":"2024-09-10T16:34:24Z","reference_number":"EMA/400811/2024","document_url":"https://www.ema.europa.eu/en/documents/work-programme/draft-3-year-rolling-work-plan-rheumatology-immunology-working-party-riwp-2025-2027_en.pdf"},
    {"id":"64784","name":"Consolidated 3-year rolling work plan for the Haematology Working Party (HAEMWP) : January 2025 - December 2027","type":"work-programme","status":"Draft: consultation closed","consultation_date":"2024-09-10 - 2024-10-10","first_published_date":"2024-09-10T16:43:33Z","last_updated_date":"2024-09-10T16:43:33Z","reference_number":"EMA/CHMP/BPWP/320406/2024","document_url":"https://www.ema.europa.eu/en/documents/work-programme/consolidated-3-year-rolling-work-plan-haematology-working-party-haemwp-january-2025-december-2027_en.pdf"},
    {"id":"65278","name":"CVMP summary of positive opinion for Duotic","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-10-11T13:17:00Z","last_updated_date":"2024-10-11T13:17:00Z","reference_number":"EMA/CVMP/446917/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-duotic_en.pdf"},
    {"id":"65279","name":"CVMP summary of positive opinion for Bravecto TriUNO","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-10-11T12:00:00Z","last_updated_date":"2024-10-11T12:00:00Z","reference_number":"EMA/CVMP/443870/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-bravecto-triuno_en.pdf"},
    {"id":"65280","name":"CVMP summary of positive opinion for Vaxxon ND Clone","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-10-11T12:00:00Z","last_updated_date":"2024-10-11T12:00:00Z","reference_number":"EMA/CVMP/446894/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vaxxon-nd-clone_en.pdf"},
    {"id":"65277","name":"CVMP post-authorisation summary of positive opinion for Eluracat (VRA-0002-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-10-11T12:00:00Z","last_updated_date":"2024-10-11T12:00:00Z","reference_number":"EMA/CVMP/446484/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-eluracat-vra-0002-g_en.pdf"},
    {"id":"65291","name":"Presentation - Joint HMA/EMA multi-stakeholder workshop on submission predictability (EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-15T09:30:00Z","last_updated_date":"2024-10-15T09:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-hma-ema-multi-stakeholder-workshop-submission-predictability-ema_en.pdf"},
    {"id":"65292","name":"Presentation - Joint HMA/EMA multi-stakeholder workshop on submission predictability (Member States)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-15T09:31:00Z","last_updated_date":"2024-10-15T09:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-hma-ema-multi-stakeholder-workshop-submission-predictability-member-states_en.pdf"},
    {"id":"65293","name":"Presentation - Update on Rapporteur appointments (A. Ganan Jimenez, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-15T09:33:00Z","last_updated_date":"2024-10-15T09:33:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-rapporteur-appointments-ganan-jimenez-ema_en.pdf"},
    {"id":"65294","name":"Presentation - Industry representatives’ viewpoints on submission predictability (P. Franco, EuropaBio)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-15T09:35:00Z","last_updated_date":"2024-10-15T09:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-representatives-viewpoints-submission-predictability-p-franco-europabio_en.pdf"},
    {"id":"65295","name":"Presentation - Panel discussion","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-15T09:36:00Z","last_updated_date":"2024-10-15T09:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-panel-discussion_en.pdf"},
    {"id":"65303","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 23-25 September 2024","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2024-10-16T10:33:00Z","last_updated_date":"2024-10-16T10:33:00Z","reference_number":"EMA/HMPC/455545/2024","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-23-25-september-2024_en.pdf"},
    {"id":"65304","name":"EMA workshop report on the future of vaccine effectiveness studies in Europe","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-10-16T10:45:18Z","last_updated_date":"2024-10-16T10:45:18Z","reference_number":"EMA/483484/2024","document_url":"https://www.ema.europa.eu/en/documents/report/ema-workshop-report-future-vaccine-effectiveness-studies-europe_en.pdf"},
    {"id":"64953","name":"Questions and answers - Quarterly System Demo - Q3 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T09:32:05Z","last_updated_date":"2024-10-16T10:46:00Z","reference_number":"EMA/438319/2024 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/other/questions-answers-quarterly-system-demo-q3-2024_en.pdf"},
    {"id":"65311","name":"cilazapril, cilazapril / hydrochlorothiazide : List of nationally authorised medicinal products - PSUSA/00000749/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-16T17:50:00Z","last_updated_date":"2024-10-16T17:50:00Z","reference_number":"EMA/473677/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/cilazapril-cilazapril-hydrochlorothiazide-list-nationally-authorised-medicinal-products-psusa-00000749-202402_en.pdf"},
    {"id":"65312","name":"Direct healthcare professional communication (DHPC) : Vabysmo (faricimab): tear in primary packaging of transfer filter needle (TFN) co-packaged with vial","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T09:00:00Z","last_updated_date":"2024-10-17T09:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-vabysmo-faricimab-tear-primary-packaging-transfer-filter-needle-tfn-co-packaged-vial_en.pdf-0"},
    {"id":"16739","name":"CHMP summary of positive opinion for Gefitinib Mylan","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2018-07-27T14:00:00Z","last_updated_date":"2024-10-17T14:00:00Z","reference_number":"EMA/489607/2018 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-gefitinib-mylan_en.pdf"},
    {"id":"65315","name":"Public statement on Gefitinib Mylan : Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T11:22:00Z","last_updated_date":"2024-10-17T11:22:00Z","reference_number":"EMA/465451/2024","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-gefitinib-mylan-withdrawal-marketing-authorisation-european-union_en.pdf"},
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    {"id":"65329","name":"Anti-HEV IgM - Notified body 0459 - 19/10/2023 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/anti-hev-igm-notified-body-0459-19-10-2023-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"65331","name":"Fetal RHD status - Notified body 2962 - 24/4/2024 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/fetal-rhd-status-notified-body-2962-24-4-2024-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
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    {"id":"62121","name":"Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA - Notified body 2797 - 19/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T17:20:00Z","last_updated_date":"2024-10-17T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/babesia-b-microti-b-duncani-b-divergens-b-venatorum-dna-rna-notified-body-2797-19-11-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62122","name":"West Nile Virus (WNV) RNA - Notified body 2797 - 12/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/west-nile-virus-wnv-rna-notified-body-2797-12-11-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62123","name":"Hepatitis E virus (HEV) - Notified body 2797 - 08/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/hepatitis-e-virus-hev-notified-body-2797-08-11-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62124","name":"Parvovirus B19 genotypes 1, 2, and 3 DNA & Hepatitis A virus (HAV) genotypes I, II, and III RNA - Notified body 2797 - 22/11/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/parvovirus-b19-genotypes-1-2-3-dna-hepatitis-virus-hav-genotypes-i-ii-iii-rna-notified-body-2797-22-11-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62120","name":"Zika Virus RNA - Notified body 2797 - 09/12/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/zika-virus-rna-notified-body-2797-09-12-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62119","name":"Chikungunya virus (CHIKV) RNA and dengue virus (DENV) RNA - Notified body 2797 - 10/12/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/chikungunya-virus-chikv-rna-dengue-virus-denv-rna-notified-body-2797-10-12-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62118","name":"Antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) - Notified body 0123 - 14/12/2021 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/antibodies-including-igg-severe-acute-respiratory-syndrome-coronavirus-2-sars-cov-2-notified-body-0123-14-12-2021-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62117","name":"SARS-CoV-2 ORF1 a/b non-structural region and nucleocapsid protein gene & Influenza A matrix gene & Influenza B non-structural protein gene - Notified body 2797 - 10/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sars-cov-2-orf1-b-non-structural-region-nucleocapsid-protein-gene-influenza-matrix-gene-influenza-b-non-structural-protein-gene-notified-body-2797-10-01-2022-view-context-performance-evaluation_en.pdf"},
    {"id":"62116","name":"IgG and IgM antibodies Treponema pallidum - Notified body 2797 - 12/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/igg-igm-antibodies-treponema-pallidum-notified-body-2797-12-01-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62110","name":"SARS-CoV-2 RdRp, E and N genes - Notified body 2797 - 20/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/sars-cov-2-rdrp-e-n-genes-notified-body-2797-20-01-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62109","name":"Antibodies to Trypanosoma cruzi - Notified body 0123 - 26/01/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/antibodies-trypanosoma-cruzi-notified-body-0123-26-01-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62108","name":"Determination of IgM antibodies to SARS-CoV-2 - Notified body 0123 - 03/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T14:20:00Z","last_updated_date":"2024-10-17T14:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/determination-igm-antibodies-sars-cov-2-notified-body-0123-03-02-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62107","name":"Determination of IgG antibodies to SARSCoV-2 - Notified body 0123 - 04/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/determination-igg-antibodies-sarscov-2-notified-body-0123-04-02-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62105","name":"Glycoprotein (GP) gene and/or nucleoprotein - Notified body 2797 - 05/09/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/glycoprotein-gp-gene-or-nucleoprotein-notified-body-2797-05-09-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62087","name":"IgG antibodies to Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) - Notified body 0123 - 16/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T16:20:00Z","last_updated_date":"2024-10-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/igg-antibodies-epstein-barr-virus-ebv-viral-capsid-antigen-vca-notified-body-0123-16-02-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
    {"id":"62106","name":"Antibodies to Treponema pallidum - Notified body 0123 - 03/02/2022 - View in the context of the performance evaluation consultation procedure (PECP)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-02-17T16:20:00Z","last_updated_date":"2024-02-17T16:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/antibodies-treponema-pallidum-notified-body-0123-03-02-2022-view-context-performance-evaluation-consultation-procedure-pecp_en.pdf"},
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    {"id":"65289","name":"Agenda - Product Management Service (PMS) Product UI training (access and navigation)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-10-14T14:48:00Z","last_updated_date":"2024-10-14T14:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-product-management-service-pms-product-ui-training-access-navigation_en.pdf-0"},
    {"id":"65288","name":"Product Lifecycle Management Portal – Human Variations eAF - Guide to navigation - October 2024 update","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-14T14:23:00Z","last_updated_date":"2024-10-14T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/product-lifecycle-management-portal-human-variations-eaf-guide-navigation-october-2024-update_en.pdf"},
    {"id":"61713","name":"Union procedure on the coordination of veterinary pharmacovigilance inspections","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-10T17:39:37Z","last_updated_date":"2024-10-16T14:00:00Z","reference_number":"EMA/INS/PhV/716593/2021 Rev 01","document_url":"https://www.ema.europa.eu/en/documents/other/union-procedure-coordination-veterinary-pharmacovigilance-inspections_en.pdf"},
    {"id":"65343","name":"CHMP post-authorisation summary of positive opinion for Yselty (II-13)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-10-18T09:59:44Z","last_updated_date":"2024-10-18T09:59:44Z","reference_number":"EMA/473427/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-yselty-ii-13_en.pdf"},
    {"id":"65318","name":"Withdrawal letter: Apremilast Viatris","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2024-10-18T11:11:01Z","last_updated_date":"2024-10-18T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-apremilast-viatris_en.pdf"},
    {"id":"65324","name":"CHMP post-authorisation summary of positive opinion for Cerdelga (X-36-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-10-18T12:00:00Z","last_updated_date":"2024-10-18T12:00:00Z","reference_number":"EMA/CHMP/477910/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cerdelga-x-36-g_en.pdf"},
    {"id":"65326","name":"CHMP post-authorisation summary of positive opinion for Kevzara (II-44)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2024-10-18T12:00:00Z","last_updated_date":"2024-10-18T12:00:00Z","reference_number":"EMA/CHMP/453178/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kevzara-ii-44_en.pdf"},
    {"id":"65327","name":"CHMP summary of positive opinion for Imuldosa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-10-18T12:00:00Z","last_updated_date":"2024-10-18T12:00:00Z","reference_number":"EMA/CHMP/448102/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imuldosa_en.pdf"},
    {"id":"65309","name":"CHMP summary of positive opinion for Wainzua","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-10-18T12:00:00Z","last_updated_date":"2024-10-18T12:00:00Z","reference_number":"EMA/CHMP/474509/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-wainzua_en.pdf"},
    {"id":"65345","name":"Withdrawal letter: Epixram","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2024-10-18T12:00:00Z","last_updated_date":"2024-10-18T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-epixram_en.pdf"},
    {"id":"65308","name":"CHMP summary of positive opinion for Eltrombopag Viatris","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-10-18T11:46:00Z","last_updated_date":"2024-10-18T11:46:00Z","reference_number":"EMA/CHMP/398947/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eltrombopag-viatris_en.pdf"},
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    {"id":"65388","name":"Presentation - Session 1 - New CTIS transparency rules - from policy to reality (Dehn, Christine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T10:00:00Z","last_updated_date":"2024-10-24T10:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-new-ctis-transparency-rules-policy-reality-dehn-christine_en.pdf"},
    {"id":"65389","name":"Presentation - Session 1 - New CTIS transparency rules - from policy to reality (Scotti, Francesca)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-new-ctis-transparency-rules-policy-reality-scotti-francesca_en.pdf"},
    {"id":"65391","name":"Presentation - Session 1 - The MSP AG and stakeholders' feedback (EHA) (El-Galaly, Tarec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-msp-ag-stakeholders-feedback-eha-el-galaly-tarec_en.pdf"},
    {"id":"65392","name":"Presentation - Session 1 - The MSP Advisory Group and stakeholders' feedback (EURORDIS) (Wheeler, Russell)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-msp-advisory-group-stakeholders-feedback-eurordis-wheeler-russell_en.pdf"},
    {"id":"65393","name":"Presentation - Session 1 - The MSP Advisory Group and stakeholders' feedback (EFPIA) (Leyens, Lada)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-msp-advisory-group-stakeholders-feedback-efpia-leyens-lada_en.pdf"},
    {"id":"65394","name":"Presentation - Session 1 - The MSP Advisory Group and stakeholders' feedback (KWF) (Hovels, Anke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-msp-advisory-group-stakeholders-feedback-kwf-hovels-anke_en.pdf"},
    {"id":"65395","name":"Presentation - Session 2 - What do the numbers tell us (Abdelall, Linda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-what-do-numbers-tell-us-abdelall-linda_en.pdf"},
    {"id":"65396","name":"Presentation - Session 2 - What do the numbers tell us (Nedog, Katarina)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-what-do-numbers-tell-us-nedog-katarina_en.pdf"},
    {"id":"65397","name":"Presentation - Session 2 - Exploring the dynamics of partner collaboration with ACT EU (Zanoletty, Ana)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-24T11:11:01Z","last_updated_date":"2024-11-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-exploring-dynamics-partner-collaboration-act-eu-zanoletty-ana_en.pdf"},
    {"id":"65399","name":"Presentation - Session 2 - Clinical Trials Coordination and Advisory Group and MedEthicsEU (Abdelall, Linda)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-clinical-trials-coordination-advisory-group-medethicseu-abdelall-linda_en.pdf"},
    {"id":"65400","name":"Presentation - Session 2 - Clinical Trials Coordination and Advisory Group and MedEthicsEU (Al, Monique)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-clinical-trials-coordination-advisory-group-medethicseu-al-monique_en.pdf"},
    {"id":"65402","name":"Presentation - Session 2 - Panel discussion (IHI) (Nathalie Seigneuret)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-discussion-ihi-nathalie-seigneuret_en.pdf"},
    {"id":"65403","name":"Presentation - Session 2 - Panel discussion (ECRIN) (Jacques Demotes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-discussion-ecrin-jacques-demotes_en.pdf"},
    {"id":"65404","name":"Presentation - Session 2 - Panel discussion (ACRO) (Leona Fitzgerald)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-panel-discussion-acro-leona-fitzgerald_en.pdf"},
    {"id":"65405","name":"Presentation - Session 3 - The EU's Political drive for clinical trials (Nimmesgern, Elmar, Clamou, Isabelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-eus-political-drive-clinical-trials-nimmesgern-elmar-clamou-isabelle_en.pdf"},
    {"id":"65406","name":"Presentation - Session 3 - Addressing stakeholder challenges - what’s next (Marianne Lunzer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-addressing-stakeholder-challenges-whats-next-marianne-lunzer_en.pdf"},
    {"id":"65407","name":"Presentation - Session 3 - Panel discusion (TEDDY) (Donato Bonifazi) ","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-discusion-teddy-donato-bonifazi_en.pdf"},
    {"id":"65408","name":"Presentation - Session 3 - Panel discusion (EHA) (Martin Kaiser)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-discusion-eha-martin-kaiser_en.pdf"},
    {"id":"65409","name":"Presentation - Session 3 - Panel discussion (CPE) (Juan Ventura)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-discussion-cpe-juan-ventura_en.pdf"},
    {"id":"65410","name":"Presentation - Session 3 - Panel discussion (EUCOPE) (Sean Byrne)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-panel-discussion-eucope-sean-byrne_en.pdf"},
    {"id":"65411","name":"Presentation - Session 3 - WHO global guidance for more effective and equitable clinical trials (Moorthy, Vasee)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-who-global-guidance-more-effective-equitable-clinical-trials-moorthy-vasee_en.pdf"},
    {"id":"65412","name":"Direct healthcare professional communication (DHPC): Medicines containing 5-fluorouracil (i.v.): In patients with moderate or severe renal impairment, DPD deficiency by measuring blood uracil levels should be interpreted with caution","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T09:30:00Z","last_updated_date":"2024-10-24T09:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-medicines-containing-5-fluorouracil-iv-patients-moderate-or-severe-renal-impairment-dpd-deficiency-measuring-blood-uracil-levels-should-be-interpreted_en.pdf"},
    {"id":"65415","name":"Presentation - Session 3 - Successfully embedding clinical research as part of healthcare (Tabernero, Josep)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:22:20Z","last_updated_date":"2024-10-24T11:22:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-successfully-embedding-clinical-research-part-healthcare-tabernero-josep_en.pdf"},
    {"id":"65420","name":"Presentation - Session 3 -  Second panel discussion (ESOP) (Mirjam Crul)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:37:16Z","last_updated_date":"2024-10-24T11:37:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-second-panel-discussion-esop-mirjam-crul_en.pdf"},
    {"id":"65421","name":"Presentation - Session 3 - Second panel discussion (EuropaBio) (Maren Koban)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T12:03:36Z","last_updated_date":"2024-10-24T12:03:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-second-panel-discussion-europabio-maren-koban_en.pdf"},
    {"id":"65416","name":"Presentation - Session 3 - Second panel discussion (UMC Utrecht) (Eduard van Beers)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:26:03Z","last_updated_date":"2024-10-24T11:26:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-second-panel-discussion-umc-utrecht-eduard-van-beers_en.pdf"},
    {"id":"65417","name":"Presentation - Session 3 - Second panel discussion (CPE) (Juan Ventura)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:29:30Z","last_updated_date":"2024-10-24T11:29:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-second-panel-discussion-cpe-juan-ventura_en.pdf"},
    {"id":"65422","name":"Presentation - Session 3 - From the theory to the practice, how will we measure success (Van Wyk, Jacobus)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T12:11:46Z","last_updated_date":"2024-10-24T12:11:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-theory-practice-how-will-we-measure-success-van-wyk-jacobus_en.pdf"},
    {"id":"65401","name":"Presentation - Session 2 - EU COMBINE project overview (Clamou, Isabelle, Tkachenko, Olga)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-10-24T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-eu-combine-project-overview-clamou-isabelle-tkachenko-olga_en.pdf"},
    {"id":"49246","name":"CHMP summary of positive opinion for Onbevzi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2020-11-13T18:31:00Z","last_updated_date":"2024-10-24T14:41:00Z","reference_number":"EMA/CHMP/576998/2020","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-onbevzi_en.pdf"},
    {"id":"65390","name":"Presentation - Session 1 - The MSP AG and stakeholders' feedback (Lacombe, Denis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T00:00:00Z","last_updated_date":"2024-10-24T00:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-msp-ag-stakeholders-feedback-lacombe-denis_en.pdf"},
    {"id":"65427","name":"Public statement on Onbevzi: Withdrawal of the marketing authorisation in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T14:46:06Z","last_updated_date":"2024-10-24T14:46:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-onbevzi-withdrawal-marketing-authorisation-european-union_en.pdf"},
    {"id":"65428","name":"Presentation - SPOR API (A. Idu, A. Sempere Sanchez) ","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T15:00:00Z","last_updated_date":"2024-10-24T15:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spor-api-idu-sempere-sanchez_en.pdf"},
    {"id":"65429","name":"Presentation - Session 1 - Towards a dataspace on animal health and welfare (D. Teixeira)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T15:09:00Z","last_updated_date":"2024-10-24T15:09:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-towards-dataspace-animal-health-welfare-d-teixeira_en.pdf"},
    {"id":"65434","name":"Highlights from the first Expert Panels and Notified Bodies workshop","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T16:58:00Z","last_updated_date":"2024-10-24T16:58:00Z","reference_number":"EMA/492346/2024","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-first-expert-panels-notified-bodies-workshop_en.pdf"},
    {"id":"65437","name":"Amitriptyline / perphenazine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"65439","name":"Agenda - SME info day","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T11:22:18Z","last_updated_date":"2024-10-25T11:22:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-sme-info-day_en.pdf"},
    {"id":"65440","name":"Presentation - SME info day - Session 1 Scientific Advice","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T11:26:39Z","last_updated_date":"2024-10-25T11:26:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day-session-1-scientific-advice_en.pdf"},
    {"id":"65441","name":"Presentation - SME info day - Session 2 - Clinical trials in the EU","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T11:29:49Z","last_updated_date":"2024-10-25T11:29:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day-session-2-clinical-trials-eu_en.pdf"},
    {"id":"65443","name":"Presentation - SME info day - Session 3 - HTA CG Joint Clinical Assessment and PICO","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T11:33:55Z","last_updated_date":"2024-10-25T11:33:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day-session-3-hta-cg-joint-clinical-assessment-pico_en.pdf"},
    {"id":"65442","name":"Presentation - SME info day - Session 3 - Implementation of the new HTA regulation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T11:32:06Z","last_updated_date":"2024-10-25T11:32:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day-session-3-implementation-new-hta-regulation_en.pdf"},
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    {"id":"65761","name":"Mesalazine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"65398","name":"Presentation - Session 2 - CTR Collaborate and CTCG action on patient involvement (Lunzer, Marianne, Al, Monique)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T11:11:01Z","last_updated_date":"2024-11-22T15:10:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-ctr-collaborate-ctcg-action-patient-involvement-lunzer-marianne-al-monique_en.pdf"},
    {"id":"65786","name":"Presentation - ESMP training session on routine shortage reporting for marketing authorisation holders of centrally authorised products","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T11:56:53Z","last_updated_date":"2024-11-25T11:56:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-esmp-training-session-routine-shortage-reporting-marketing-authorisation-holders-centrally-authorised-products_en.pdf"},
    {"id":"65787","name":"Presentation - Patient and HCP engagement highlights 2024 (M. Carr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T12:02:41Z","last_updated_date":"2024-11-25T12:02:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-hcp-engagement-highlights-2024-m-carr_en.pdf"},
    {"id":"63133","name":"Draft guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2024-05-02 - 2024-08-31","first_published_date":"2024-05-02T09:25:30Z","last_updated_date":"2024-05-02T09:25:30Z","reference_number":"EMA/CVMP/QWP/515653/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products_en.pdf"},
    {"id":"65789","name":"Presentation - Multi-stakeholder platform meeting: Accelerating clinical trials in the EU (ACT EU) initiative (A. Zanoletty, D. Lacombe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:09:14Z","last_updated_date":"2024-11-25T13:09:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-stakeholder-platform-meeting-accelerating-clinical-trials-eu-act-eu-initiative-zanoletty-d-lacombe_en.pdf"},
    {"id":"65790","name":"Presentation - The new version of the public portal (F. Scotti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:10:28Z","last_updated_date":"2024-11-25T13:10:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-version-public-portal-f-scotti_en.pdf"},
    {"id":"65791","name":"Presentation - Clinical data publication - next steps (K. Quigley)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:11:26Z","last_updated_date":"2024-11-25T13:11:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-data-publication-next-steps-k-quigley_en.pdf"},
    {"id":"65794","name":"Presentation - Big Data Steering Group ongoing activities (F. Domergue, D. Umuhire)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:17:40Z","last_updated_date":"2024-11-25T13:17:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-big-data-steering-group-ongoing-activities-f-domergue-d-umuhire_en.pdf"},
    {"id":"65795","name":"Presentation - Patient experience data - Reflection paper and upcoming consultation (R. Gonzalez-Quevedo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:19:14Z","last_updated_date":"2024-11-25T13:19:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-reflection-paper-upcoming-consultation-r-gonzalez-quevedo_en.pdf"},
    {"id":"65796","name":"Presentation - Multi-annual AI Workplan - Update (L. Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:24:30Z","last_updated_date":"2024-11-25T13:24:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-annual-ai-workplan-update-l-pinheiro_en.pdf"},
    {"id":"65797","name":"Presentation - Update on the publication of version 2 of the Union list of critical medicines (ULCM) (J. Ferreira)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:26:36Z","last_updated_date":"2024-11-25T13:26:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-publication-version-2-union-list-critical-medicines-ulcm-j-ferreira_en.pdf"},
    {"id":"65798","name":"Presentation - Update on the new Medicine Shortage Communication (MSC) process and template (J. Ferreira)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:27:32Z","last_updated_date":"2024-11-25T13:27:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-new-medicine-shortage-communication-msc-process-template-j-ferreira_en.pdf"},
    {"id":"65799","name":"Presentation - Feedback on SPOC Working Party activities on GLP-1 receptor agonists and insulin products shortage management (K. Kruttwig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T13:29:27Z","last_updated_date":"2024-11-25T13:29:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-spoc-working-party-activities-glp-1-receptor-agonists-insulin-products-shortage-management-k-kruttwig_en.pdf"},
    {"id":"65800","name":"Minutes of the HMPC meeting 23-25 September 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2024-11-25T13:53:29Z","last_updated_date":"2024-11-25T13:53:29Z","reference_number":"EMA/HMPC/478382/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-hmpc-meeting-23-25-september-2024_en.pdf"},
    {"id":"65801","name":"Presentation - Communication at EMA (M. Benstetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T14:04:41Z","last_updated_date":"2024-11-25T14:04:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communication-ema-m-benstetter_en.pdf"},
    {"id":"65802","name":"Presentation - Communicating about shortages (G. Gabrielli, L. Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T14:06:06Z","last_updated_date":"2024-11-25T14:06:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communicating-about-shortages-g-gabrielli-l-herold_en.pdf"},
    {"id":"65803","name":"Presentation - Key user group for the EMA corporate website (I. Matos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T14:07:11Z","last_updated_date":"2024-11-25T14:07:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-user-group-ema-corporate-website-i-matos_en.pdf"},
    {"id":"65804","name":"Presentation - Key dates 2025 (J. Garcia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T14:08:36Z","last_updated_date":"2024-11-25T14:08:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-key-dates-2025-j-garcia_en.pdf"},
    {"id":"65805","name":"Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-11-25T14:25:43Z","last_updated_date":"2024-11-25T14:25:43Z","reference_number":"EMA/CVMP/QWP/515653/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products_en.pdf"},
    {"id":"65806","name":"Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products' (EMA/CVMP/QWP/515653/2023)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T14:25:42Z","last_updated_date":"2024-11-25T14:25:42Z","reference_number":"EMA/CVMP/QWP/416589/2024","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products-ema-cvmp-qwp-515653-2023_en.pdf"},
    {"id":"65807","name":"Agenda of the PRAC meeting 25-28 November 2024","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-11-25T15:41:37Z","last_updated_date":"2024-11-25T15:41:37Z","reference_number":"EMA/PRAC/520862/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-meeting-25-28-november-2024_en.pdf"},
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    {"id":"65812","name":"Presentation - Clinical Study Data Pilot (E. Psarelli, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T17:08:45Z","last_updated_date":"2024-11-25T17:08:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-study-data-pilot-e-psarelli-ema_en.pdf"},
    {"id":"65813","name":"Presentation - Lifecycle management of combination products at post-authorisation (C.Bouygues, C.Vicenzi, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-25T17:09:41Z","last_updated_date":"2024-11-25T17:09:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lifecycle-management-combination-products-post-authorisation-cbouygues-cvicenzi-ema_en.pdf"},
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    {"id":"65664","name":"Questions and answers on the refusal of the marketing authorisation for Cinainu (extracts from Allium cepa (onion) fresh bulb and Citrus limon (lemon) fresh fruit, Paullinia cupana (guarana) seed, and Theobroma cacao (cocoa) seed) ","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2024-11-15T12:00:00Z","last_updated_date":"2024-11-27T13:22:00Z","reference_number":"EMA/529369/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-cinainu-extracts-allium-cepa-onion-fresh-bulb-citrus-limon-lemon-fresh-fruit-paullinia-cupana-guarana-seed-theobroma-cacao-cocoa-seed_en.pdf"},
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    {"id":"49350","name":"European Medicines Agency's privacy statement for media professionals","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-10-28T17:21:10Z","last_updated_date":"2024-10-28T17:21:10Z","reference_number":"EMA/416293/2020","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-privacy-statement-media-professionals_en.pdf"},
    {"id":"65855","name":"Ketoprofen (poultry): European Public MRL Assessment Report (EPMAR) - CVMP","type":"mrl-report","status":"unknown","consultation_date":"","first_published_date":"2024-11-28T10:33:52Z","last_updated_date":"2024-11-28T10:33:52Z","reference_number":"EMA/CVMP/505842/2023","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/ketoprofen-poultry-european-public-mrl-assessment-report-epmar-cvmp_en.pdf"},
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    {"id":"65865","name":"Minutes of the CAT meeting 9-11 October 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2024-11-28T13:43:54Z","last_updated_date":"2024-11-28T13:43:54Z","reference_number":"EMA/CAT/554433/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-9-11-october-2024_en.pdf"},
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    {"id":"65878","name":"Submission of comments template for ICH E6(R3) Annex 2","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2024-11-29T16:59:44Z","last_updated_date":"2024-11-29T16:59:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-template-ich-e6r3-annex-2_en.xlsx"},
    {"id":"65886","name":"Chlorprothixene : List of nationally authorised medicinal products - PSUSA/00000717/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-29T16:10:26Z","last_updated_date":"2024-11-29T16:10:26Z","reference_number":"EMA/557829/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorprothixene-list-nationally-authorised-medicinal-products-psusa-00000717-202403_en.pdf"},
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    {"id":"63886","name":"Draft VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision 2","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2024-06-21 - 2024-11-30","first_published_date":"2024-07-05T09:17:56Z","last_updated_date":"2024-07-05T09:17:56Z","reference_number":"EMA/CVMP/VICH/526/2000","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-vich-gl23-studies-evaluate-safety-residues-veterinary-drugs-human-food-genotoxicity-testing-revision-2_en.pdf"},
    {"id":"65242","name":"Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (draft)","type":"other","status":"Draft: consultation closed","consultation_date":"2024-10-09 - 2024-11-30","first_published_date":"2024-10-09T13:56:00Z","last_updated_date":"2024-10-09T13:56:00Z","reference_number":"EMA/376542/2024","document_url":"https://www.ema.europa.eu/en/documents/other/seizing-opportunities-changing-medicines-landscape-european-medicines-agencies-network-strategy-2028-draft_en.pdf"},
    {"id":"65567","name":"Revised list of enabling tools","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2024-11-08 - 2024-11-30","first_published_date":"2024-11-08T09:10:34Z","last_updated_date":"2024-11-08T09:10:34Z","reference_number":"EMA/515876/2024","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/revised-list-enabling-tools_en.pdf"},
    {"id":"65896","name":"Direct healthcare professional communication (DHPC): Metamizole-containing medicines: important measures to minimise the serious outcomes of known risk of agranulocytosis","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:22:03Z","last_updated_date":"2024-12-03T09:22:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-metamizole-containing-medicines-important-measures-minimise-serious-outcomes-known-risk-agranulocytosis_en.pdf"},
    {"id":"65897","name":"Presentation - The landscape for ATMPs in Europe 15 years after the initial introduction of the Regulation (K.Breen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:34:18Z","last_updated_date":"2024-12-03T09:34:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-landscape-atmps-europe-15-years-after-initial-introduction-regulation-kbreen-ema_en.pdf"},
    {"id":"65898","name":"Presentation - survey to gather developers' view on challenges and opportunities in ATMP development  (M.Di Marzo, AIFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:37:25Z","last_updated_date":"2024-12-03T09:37:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-survey-gather-developers-view-challenges-opportunities-atmp-development-mdi-marzo-aifa_en.pdf"},
    {"id":"65899","name":"Presentation - Journey of ATMPs from early development to access in EU (F.Locatelli, Bambino Gesu Childrens Hospital)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:38:07Z","last_updated_date":"2024-12-03T09:38:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-journey-atmps-early-development-access-eu-flocatelli-bambino-gesu-childrens-hospital_en.pdf"},
    {"id":"65900","name":"Presentation - (Regulatory) Challenges in the development of a CRISPR/Cas9 edited tacrolimus-resistant regulatory T cell product (L.Amini, BeCAT Therapies)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:39:36Z","last_updated_date":"2024-12-03T09:39:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-challenges-development-crispr-cas9-edited-tacrolimus-resistant-regulatory-t-cell-product-lamini-becat-therapies_en.pdf"},
    {"id":"65901","name":"Presentation - The journey of ATMPs from early development to access in EU: challenges and opportunitiesSME perspective (A. Natz, EUCOPE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:40:32Z","last_updated_date":"2024-12-03T09:40:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-journey-atmps-early-development-access-eu-challenges-opportunitiessme-perspective-natz-eucope_en.pdf"},
    {"id":"65613","name":"Presentation - Training webinar on post-authorisation procedure management in IRIS for Marketing Authorisation Holders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-11-13T15:56:18Z","last_updated_date":"2024-12-03T09:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-training-webinar-post-authorisation-procedure-management-iris-marketing-authorisation-holders_en.pdf"},
    {"id":"65902","name":"Presentation - Translating Innovation into Access for ATMPs - Industry Perspective (M.Cattani, Farmindustria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:41:12Z","last_updated_date":"2024-12-03T09:41:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-translating-innovation-access-atmps-industry-perspective-mcattani-farmindustria_en.pdf"},
    {"id":"65903","name":"Presentation - EMA support to innovation - Translating innovation into access for ATMPs (V.Cordo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:42:14Z","last_updated_date":"2024-12-03T09:42:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-support-innovation-translating-innovation-access-atmps-vcordo-ema_en.pdf"},
    {"id":"65904","name":"Presentation - National Competent Authorities support to innovation - Translating innovationi nto access for ATMPs (E.Agricola, AIFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:43:31Z","last_updated_date":"2024-12-03T09:43:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-national-competent-authorities-support-innovation-translating-innovationi-nto-access-atmps-eagricola-aifa_en.pdf"},
    {"id":"65906","name":"Presentation - EU4Health Programme (G.Simone, HaDEA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:45:14Z","last_updated_date":"2024-12-03T09:45:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu4health-programme-gsimone-hadea_en.pdf"},
    {"id":"65907","name":"Presentation - Horizon Europe funding programme - ATMPs (A-P. Papageorgiou, DG Research and Innovation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:46:22Z","last_updated_date":"2024-12-03T09:46:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-horizon-europe-funding-programme-atmps-p-papageorgiou-dg-research-innovation_en.pdf"},
    {"id":"65908","name":"Presentation - Strenghtening the European innovation ecosystem (T.Humphreys)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:47:19Z","last_updated_date":"2024-12-03T09:47:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-strenghtening-european-innovation-ecosystem-thumphreys_en.pdf"},
    {"id":"65909","name":"Presentation - The GMO framework (C.Beuneu, FAMHP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:54:39Z","last_updated_date":"2024-12-03T09:54:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gmo-framework-cbeuneu-famhp_en.pdf"},
    {"id":"65910","name":"Presentation - Combined developments CTR, MDR, IVDR (I.Reischl, BASG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:55:34Z","last_updated_date":"2024-12-03T09:55:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-combined-developments-ctr-mdr-ivdr-ireischl-basg_en.pdf"},
    {"id":"65911","name":"Presentation - Hospital Exemption - Non repetitive use of Advanced Therapy Medicines (S.Petraglia, AIFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:56:18Z","last_updated_date":"2024-12-03T09:56:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hospital-exemption-non-repetitive-use-advanced-therapy-medicines-spetraglia-aifa_en.pdf"},
    {"id":"65912","name":"Presentation - Case studies of academic development of ATMP: ARI0001 and ARI0002h (G.Calvo, Hospital Clinic Barcelona)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:57:06Z","last_updated_date":"2024-12-03T09:57:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-studies-academic-development-atmp-ari0001-ari0002h-gcalvo-hospital-clinic-barcelona_en.pdf"},
    {"id":"65914","name":"Agenda of the CVMP meeting 3-5 December 2024","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2024-12-03T11:33:23Z","last_updated_date":"2024-12-03T11:33:23Z","reference_number":"EMA/558441/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-3-5-december-2024_en.pdf"},
    {"id":"65590","name":"Agenda - Quarterly System Demo Q4 2024","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-11-11T16:03:30Z","last_updated_date":"2024-12-03T14:07:00Z","reference_number":"EMA/517039/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-quarterly-system-demo-q4-2024_en.pdf"},
    {"id":"62380","name":"P/0067/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for camlipixant (EMEA-003334-PIP01-22)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T16:56:52Z","last_updated_date":"2024-02-29T16:56:52Z","reference_number":"EMA/84285/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/p-0067-2023-ema-decision-10-march-2023-granting-product-specific-waiver-camlipixant-emea-003334-pip01-22_en.pdf"},
    {"id":"62377","name":"P/0076/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for clascoterone (EMEA-003330-PIP01-22)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T16:43:48Z","last_updated_date":"2024-02-29T16:43:48Z","reference_number":"EMA/85651/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/p-0076-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-waiver-clascoterone-emea-003330-pip01-22_en.pdf"},
    {"id":"61661","name":"P/0043/2022: EMA decision of 10 February 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for acetyl-Lleucine ((s)-(acetylamino)-4-methylpentanoic acid) (IB1001) (EMEA-002796-PIP01-20)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2023-04-12T14:33:19Z","last_updated_date":"2023-04-12T14:33:19Z","reference_number":"EMA/65204/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/p-0043-2022-ema-decision-10-february-2022-agreement-paediatric-investigation-plan-granting-deferral-acetyl-lleucine-s-acetylamino-4-methylpentanoic-acid-ib1001-emea-002796-pip01-20_en.pdf"},
    {"id":"14824","name":"Public summary of the evaluation of a proposed product-specific waiver: Allantoin for treatment of epidermolysis bullosa","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/422646/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-allantoin-treatment-epidermolysis-bullosa_en.pdf"},
    {"id":"36910","name":"Public summary of the evaluation of a proposed product-specific waiver: Norovirus GI.1 and GII.4 virus-like particle antigens for the prevention of acute norovirus gastroenteritis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/78811/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-norovirus-gi1-gii4-virus-particle-antigens-prevention-acute-norovirus-gastroenteritis_en.pdf"},
    {"id":"31257","name":"Public summary of the evaluation of a proposed product-specific waiver: Hydrochlorothiazide / nebivolol (hydrochloride) for treatment of hypertension","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/781918/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-hydrochlorothiazide-nebivolol-hydrochloride-treatment-hypertension_en.pdf"},
    {"id":"30394","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Finerenone for treatment of chronic kidney disease","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/652539/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-finerenone-treatment-chronic-kidney-disease_en.pdf"},
    {"id":"26353","name":"Public summary of the evaluation of the proposed paediatric investigation plan: (R)-2-[3-({Benzoxazol-2-yl[3-(4-methoxyphenoxy)propyl]amino}methyl) phenoxy]butanoic acid for the reduction of residual cardiovascular event...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/689646/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-r-2-3-benzoxazol-2-yl3-4-methoxyphenoxypropylaminomethyl-phenoxybutanoic-acid-reduction-residual-cardiovascular-event_en.pdf"},
    {"id":"11357","name":"Public summary of the evaluation of a proposed product-specific waiver: Daclatasvir (dihydrochloride) / asunaprevir / (1ar,12bs)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/399003/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-daclatasvir-dihydrochloride-asunaprevir-1ar12bs-8-cyclohexyl-n-dimethylsulfamoyl-11-methoxy-1a-1r5s-3-methyl-38-diazabicyclo321_en.pdf"},
    {"id":"34966","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]-oxy}methyl)(phenoxy) phosphoryl]-l-alaninate, (2E)-but-2-enedioate (2:1) (G...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/578912/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-propan-2-yl-n-s-2r-1-6-amino-9h-purin-9-ylpropan-2-yl-oxymethylphenoxy-phosphoryl-l-alaninate-2e-2-enedioate-21-g_en.pdf"},
    {"id":"27040","name":"Public summary of the evaluation of a proposed product-specific waiver:  Emtricitabine / rilpivirine / tenofovir alafenamide for the treatment of human immunodeficiency virus (HIV-1) infection","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/75638/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-emtricitabine-rilpivirine-tenofovir-alafenamide-treatment-human-immunodeficiency-virus-hiv-1-infection_en.pdf"},
    {"id":"28059","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Dasabuvir/ombitasvir/paritaprevir/ritonavir for the treatment of chronic hepatitis C","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/483000/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-dasabuvir-ombitasvir-paritaprevir-ritonavir-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"18994","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Efinaconazole for treatment of onychomycosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T17:30:00Z","last_updated_date":"2015-05-19T17:30:00Z","reference_number":"EMA/190891/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-efinaconazole-treatment-onychomycosis_en.pdf"},
    {"id":"40279","name":"Public summary of the evaluation of a proposed product-specific waiver:  Ezetimibe / atorvastatin (calcium trihydrate) for the prevention of coronary artery disease","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/397480/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-ezetimibe-atorvastatin-calcium-trihydrate-prevention-coronary-artery-disease_en.pdf"},
    {"id":"9056","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Osilodrostat for the treatment of adrenal cortical hyperfunction","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/799607/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-osilodrostat-treatment-adrenal-cortical-hyperfunction_en.pdf"},
    {"id":"6539","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Fluciclovine (18F) for diagnosis of amino acid metabolism in solid malignant tumours","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/251728/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-fluciclovine-18f-diagnosis-amino-acid-metabolism-solid-malignant-tumours_en.pdf"},
    {"id":"16034","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Eravacycline for the treatment of complicated intra-abdominal infections and for the treatment of urinary tract infections","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-05-19T17:30:00Z","last_updated_date":"2015-05-19T17:30:00Z","reference_number":"EMA/412277/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-eravacycline-treatment-complicated-intra-abdominal-infections-treatment-urinary-tract-infections_en.pdf"},
    {"id":"37438","name":"Public summary of the evaluation of a proposed product-specific waiver: Anti programmed death-ligand 1 (PD-L1) monoclonal antibody (MPDL3280A) for treatment of all conditions included in the category of malignant neoplas...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/316693/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-anti-programmed-death-ligand-1-pd-l1-monoclonal-antibody-mpdl3280a-treatment-all-conditions-included-category-malignant-neoplas_en.pdf"},
    {"id":"25700","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Human normal immunoglobulin for treatment of primary immunodeficiency","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/258812/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-human-normal-immunoglobulin-treatment-primary-immunodeficiency_en.pdf"},
    {"id":"33903","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Dapagliflozin (Forxiga) for the treatment of type-1 diabetes mellitus","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/255315/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-dapagliflozin-forxiga-treatment-type-1-diabetes-mellitus_en.pdf"},
    {"id":"37229","name":"Public summary of the evaluation of a proposed product-specific waiver: Human recombinant interleukin-2 for treatment of type-1 diabetes mellitus","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/408266/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-human-recombinant-interleukin-2-treatment-type-1-diabetes-mellitus_en.pdf"},
    {"id":"22494","name":"Public summary of the evaluation of the proposed product-specific waiver: \n\nSaxagliptin/dapagliflozin for the treatment of type 2 diabetes mellitus","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-03-10T01:00:00Z","last_updated_date":"2015-03-10T01:00:00Z","reference_number":"EMA/141125/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-saxagliptin-dapagliflozin-treatment-type-2-diabetes-mellitus_en.pdf"},
    {"id":"31817","name":"Public summary of the evaluation of a proposed product-specific waiver: Semaglutide for treatment of type-2 diabetes mellitus","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/400078/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-semaglutide-treatment-type-2-diabetes-mellitus_en.pdf"},
    {"id":"27686","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Tofacitinib for treatment of ulcerative colitis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T11:55:00Z","last_updated_date":"2014-10-21T11:55:00Z","reference_number":"EMA/488667/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-tofacitinib-treatment-ulcerative-colitis_en.pdf"},
    {"id":"37130","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Recombinant parathyroid hormone for treatment of hypoparathyroidism","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/224879/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-recombinant-parathyroid-hormone-treatment-hypoparathyroidism_en.pdf"},
    {"id":"18803","name":"Public summary of the evaluation of a proposed product-specific waiver: Humanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A (CIM331)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/422651/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-humanised-monoclonal-antibody-igg2-recognising-interleukin-31-receptor-cim331_en.pdf"},
    {"id":"33365","name":"Public summary of the evaluation of a proposed product-specific waiver: DNA, d(P-thio)([2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rC-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/739394/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-dna-dp-thio2-0-2-methoxyethylm5ru-2-0-2-methoxyethylm5rc-2-0-2-methoxyethylm5ru-2-0-2-methoxyethylm5ru-2-0-2-methoxyethyl_en.pdf"},
    {"id":"5728","name":"Public summary of the evaluation of a proposed product-specific waiver:  Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (CTL019)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/198001/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-autologous-t-cells-transduced-lentiviral-vector-containing-chimeric-antigen-receptor-directed-against-cd19-ctl019_en.pdf"},
    {"id":"10240","name":"Public summary of the evaluation of a proposed paediatric investigation plan: (3-((4-Benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1H-1,2,4-triazol-1-yl)-1H-pyrrolo[2,3-c]pyridin-1-yl)methyl dihydrogen phospha...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/481796/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-3-4-benzoyl-1-piperazinyloxoacetyl-4-methoxy-7-3-methyl-1h-124-triazol-1-yl-1h-pyrrolo23-cpyridin-1-ylmethyl-dihydrogen-phospha_en.pdf"},
    {"id":"33135","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene for the treatment of genetic congenital retinal disorders","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/556214/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-adenovirus-associated-viral-vector-serotype-2-containing-human-rpe65-gene-treatment-genetic-congenital-retinal-disorders_en.pdf"},
    {"id":"31401","name":"Public summary of the evaluation of the proposed paediatric investigation plan: human autologous bone marrow-derived osteoblastic cells for the treatment of non-traumatic osteonecrosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-07-31T17:45:00Z","last_updated_date":"2014-07-31T17:45:00Z","reference_number":"EMA/426630/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-human-autologous-bone-marrow-derived-osteoblastic-cells-treatment-non-traumatic-osteonecrosis_en.pdf"},
    {"id":"39746","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Potassium citrate monohydrated / potassium hydrogen carbonate for treatment of renal tubular acidosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-25T12:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/690282/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-potassium-citrate-monohydrated-potassium-hydrogen-carbonate-treatment-renal-tubular-acidosis_en.pdf"},
    {"id":"27420","name":"Public summary of the evaluation of a proposed product-specific waiver: Belimumab for treatment of systemic lupus erythematosus","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/422634/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-belimumab-treatment-systemic-lupus-erythematosus_en.pdf"},
    {"id":"8465","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Dupilumab for treatment of nasal polyposis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/134872/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-dupilumab-treatment-nasal-polyposis_en.pdf"},
    {"id":"24785","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Peanut allergen extract for the treatment of peanut allergy","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/131917/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-peanut-allergen-extract-treatment-peanut-allergy_en.pdf"},
    {"id":"23828","name":"Public summary of the evaluation of a proposed product-specific waiver:  Canakinumab for the treatment of familial Mediterranean fever (FMF) and treatment of hyperimmunoglobulin D syndrome","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/318230/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-canakinumab-treatment-familial-mediterranean-fever-fmf-treatment-hyperimmunoglobulin-d-syndrome_en.pdf"},
    {"id":"6892","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Ibuprofen (sodium dihydrate) for treatment of pain and treatment of febrile disorders","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-25T12:30:00Z","last_updated_date":"2014-11-25T12:30:00Z","reference_number":"EMA/690115/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-ibuprofen-sodium-dihydrate-treatment-pain-treatment-febrile-disorders_en.pdf"},
    {"id":"30242","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Mirabegron for the treatment of neurogenic detrusor overactivity","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/501567/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-mirabegron-treatment-neurogenic-detrusor-overactivity_en.pdf"},
    {"id":"5473","name":"Public summary of the evaluation of a proposed product-specific waiver: Azithromycin for treatment of bacterial conjunctivitis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/774547/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-azithromycin-treatment-bacterial-conjunctivitis_en.pdf"},
    {"id":"29251","name":"Public summary of the evaluation of a proposed product-specific waiver: Misoprostol for induction of labour","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/514404/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-misoprostol-induction-labour_en.pdf"},
    {"id":"12796","name":"Public summary of the evaluation of a proposed product-specific waiver: Rifamycin for treatment of acute infectious diarrhoea","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/759331/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-rifamycin-treatment-acute-infectious-diarrhoea_en.pdf"},
    {"id":"4681","name":"Public summary of the evaluation of the proposed product-specific waiver: Tirasemtiv for the treatment of amyotrophic lateral sclerosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-10-21T12:55:00Z","last_updated_date":"2014-10-21T12:55:00Z","reference_number":"EMA/510083/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-tirasemtiv-treatment-amyotrophic-lateral-sclerosis_en.pdf"},
    {"id":"30342","name":"Public summary of the evaluation of a proposed product-specific waiver: Botulinum Neurotoxin Type A for Treatment of muscle induced wrinkles","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/774930/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-botulinum-neurotoxin-type-treatment-muscle-induced-wrinkles_en.pdf"},
    {"id":"40996","name":"Public summary of the evaluation of a proposed product-specific waiver:  Canakinumab for treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/318226/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-canakinumab-treatment-tumour-necrosis-factor-tnf-receptor-associated-periodic-syndrome_en.pdf"},
    {"id":"32037","name":"Public summary of the evaluation of a proposed product-specific waiver: Recombinant human N-acetylglucosaminidase (rhNAGLU) for treatment of mucopolysaccharidosis IIIB (Sanfilippo B)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/423607/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-recombinant-human-n-acetylglucosaminidase-rhnaglu-treatment-mucopolysaccharidosis-iiib-sanfilippo-b_en.pdf"},
    {"id":"29150","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Grazoprevir for the treatment of chronic hepatitis C","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/750560/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-grazoprevir-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"20438","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Natural, unmodified antisense oligonucleotide (30-mer) with nucleotide sequence 5”²-GTAATTGCGGCAAGAAGAATTGTTTCTGTC-3”²(CODA001) for treatmen...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/420714/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-natural-unmodified-antisense-oligonucleotide-30-mer-nucleotide-sequence-52-gtaattgcggcaagaagaattgtttctgtc-32coda001-treatmen_en.pdf"},
    {"id":"29424","name":"Public summary of the evaluation of a proposed product-specific waiver: Oxycodone (hydrochloride) / naloxone (hydrochloride) for treatment of pain with opioid-induced constipation","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/33307/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-oxycodone-hydrochloride-naloxone-hydrochloride-treatment-pain-opioid-induced-constipation_en.pdf"},
    {"id":"23912","name":"Public summary of the evaluation of a proposed product-specific waiver: Simtuzumab for treatment of hepatic fibrosis and hepatic cirrhosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/51495/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-simtuzumab-treatment-hepatic-fibrosis-hepatic-cirrhosis_en.pdf"},
    {"id":"33187","name":"Public summary of the evaluation of a proposed product-specific waiver:  Ibodutant for treatment of diarrhoea-predominant Irritable Bowel Syndrome (IBS-d)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/396300/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-ibodutant-treatment-diarrhoea-predominant-irritable-bowel-syndrome-ibs-d_en.pdf"},
    {"id":"8020","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Silicic acid, sodium zirconium (4+) salt (3:2:1) hydrate for treatment of hyperkalaemia","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/579541/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-silicic-acid-sodium-zirconium-4-salt-321-hydrate-treatment-hyperkalaemia_en.pdf"},
    {"id":"10910","name":"Public summary of the evaluation of a proposed paediatric investigation plan:  Calcipotriol for treatment of psoriasis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/604233/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-calcipotriol-treatment-psoriasis_en.pdf"},
    {"id":"14441","name":"Public summary of the evaluation of a proposed product-specific waiver: Torasemide / lisinopril for treatment of hypertension and treatment of heart failure","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/781915/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-torasemide-lisinopril-treatment-hypertension-treatment-heart-failure_en.pdf"},
    {"id":"9084","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Pandemic live attenuated influenza virus (H5N1) for prevention of influenza infection","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T12:15:00Z","last_updated_date":"2014-12-12T12:15:00Z","reference_number":"EMA/662484/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-pandemic-live-attenuated-influenza-virus-h5n1-prevention-influenza-infection_en.pdf"},
    {"id":"27648","name":"Public summary of the evaluation of a proposed product-specific waiver:  Reparixin for prevention of graft rejection","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/288173/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-reparixin-prevention-graft-rejection_en.pdf"},
    {"id":"40759","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Inotuzumab ozogamicin for treatment of acute lymphoblastic leukaemia","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T12:15:00Z","last_updated_date":"2014-12-12T12:15:00Z","reference_number":"EMA/662484/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-inotuzumab-ozogamicin-treatment-acute-lymphoblastic-leukaemia_en.pdf"},
    {"id":"37054","name":"Public summary of the evaluation of a proposed product-specific\n\nwaiver: Zoledronic acid (monohydrate) (in combination with calcium (carbonate) / cholecalciferol) for prevention of skeletal related events in patients wit...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-02-23T12:30:00Z","last_updated_date":"2015-02-23T12:30:00Z","reference_number":"EMA/69027/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-zoledronic-acid-monohydrate-combination-calcium-carbonate-cholecalciferol-prevention-skeletal-related-events-patients-wit_en.pdf"},
    {"id":"17740","name":"Public summary of the evaluation of a proposed product-specific waiver: Hydromorphone (hydrochloride) / naloxone (hydrochloride) for treatment of pain and treatment of opioid-induced constipation","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/33305/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-hydromorphone-hydrochloride-naloxone-hydrochloride-treatment-pain-treatment-opioid-induced-constipation_en.pdf"},
    {"id":"8710","name":"Public summary of the evaluation of a proposed product-specific waiver: Ibuprofen / codeine for treatment of pain","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/86209/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-ibuprofen-codeine-treatment-pain_en.pdf"},
    {"id":"37532","name":"Public summary of the evaluation of a proposed product-specific waiver: Alpha Connexin C-terminal 1 peptide (ACT1) for treatment of venous leg ulcer and for treatment of diabetic foot ulcer","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/662484/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-alpha-connexin-c-terminal-1-peptide-act1-treatment-venous-leg-ulcer-treatment-diabetic-foot-ulcer_en.pdf"},
    {"id":"11449","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Captopril for treatment of heart failure","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/689544/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-captopril-treatment-heart-failure_en.pdf"},
    {"id":"17902","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Glucagon for treatment of hypoglycaemia","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/364295/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-glucagon-treatment-hypoglycaemia_en.pdf"},
    {"id":"29078","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomavirus strain 16 (reco...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-12-12T12:15:00Z","last_updated_date":"2014-12-12T12:15:00Z","reference_number":"EMA/662484/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-purified-adenylate-cyclase-recombinant-protein-carrying-subfragments-early-protein-e7-antigen-human-papillomavirus-strain-16-reco_en.pdf"},
    {"id":"19074","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Begelomab for the treatment of acute graft-versus-host disease (aGvHD)","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/634502/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-begelomab-treatment-acute-graft-versus-host-disease-agvhd_en.pdf"},
    {"id":"29067","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Perindopril / bisoprolol for treatment of ischaemic coronary artery disorders, treatment of hypertension and treatment of heart failure","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/490953/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-perindopril-bisoprolol-treatment-ischaemic-coronary-artery-disorders-treatment-hypertension-treatment-heart-failure_en.pdf"},
    {"id":"36507","name":"Public summary of the evaluation of a proposed product-specific waiver: Masitinib (mesylate) for treatment of mastocytosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/366250/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-masitinib-mesylate-treatment-mastocytosis_en.pdf"},
    {"id":"15961","name":"Public summary of the evaluation of a proposed product-specific waiver: Brentuximab vedotin for treatment of Cutaneous T-Cell Lymphoma","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/702731/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-brentuximab-vedotin-treatment-cutaneous-t-cell-lymphoma_en.pdf"},
    {"id":"23608","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Bromfenac (sodium sesquihydrate) for prevention and treatment of postoperative pain and inflammation associated with cataract surgery","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/689360/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-bromfenac-sodium-sesquihydrate-prevention-treatment-postoperative-pain-inflammation-associated-cataract-surgery_en.pdf"},
    {"id":"40535","name":"Public summary of the evaluation of a proposed product-specific waiver:  L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser for treatment of sarcoidosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/396199/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-l-pyr-l-glu-l-gln-l-leu-l-glu-l-arg-l-ala-l-leu-l-asn-l-ser-l-ser-treatment-sarcoidosis_en.pdf"},
    {"id":"6690","name":"Public summary of the evaluation of a proposed product-specific waiver: Candesartan / amlodipine for treatment of hypertension","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/49429/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-candesartan-amlodipine-treatment-hypertension_en.pdf"},
    {"id":"37689","name":"Public summary of the evaluation of a proposed product-specific waiver: Autologous bone marrow-derived cardiopoietic stem cells for the treatment of ischemic heart disease","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/292145/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-autologous-bone-marrow-derived-cardiopoietic-stem-cells-treatment-ischemic-heart-disease_en.pdf"},
    {"id":"41942","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Acotiamide for treatment of functional dyspepsia","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/774861/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-acotiamide-treatment-functional-dyspepsia_en.pdf"},
    {"id":"13559","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Elbasvir for the treatment of chronic hepatitis C","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/750556/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-elbasvir-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"27756","name":"Public summary of the evaluation of the proposed paediatric investigation plan: Rosuvastatin / valsartan for treatment of hypertension, treatment of dyslipidaemia and prevention of cardiovascular events","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2014-11-14T01:00:00Z","last_updated_date":"2014-11-14T01:00:00Z","reference_number":"EMA/688859/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-rosuvastatin-valsartan-treatment-hypertension-treatment-dyslipidaemia-prevention-cardiovascular-events_en.pdf"},
    {"id":"15779","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Grazoprevir/elbasvir for the treatment of chronic hepatitis C","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T18:00:00Z","last_updated_date":"2016-07-11T18:00:00Z","reference_number":"EMA/750477/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-grazoprevir-elbasvir-treatment-chronic-hepatitis-c_en.pdf"},
    {"id":"26894","name":"Public summary of the evaluation of a proposed product-specific waiver: Palovarotene for treatment of fibrodysplasia ossificans progressiva","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/472340/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-palovarotene-treatment-fibrodysplasia-ossificans-progressiva_en.pdf"},
    {"id":"5745","name":"Public summary of the evaluation of a proposed product-specific waiver: Levomilnacipran for the treatment of stroke","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/566825/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-levomilnacipran-treatment-stroke_en.pdf"},
    {"id":"33649","name":"Public summary of the evaluation of a proposed product-specific waiver: Hydromorphone (hydrochloride) / naloxone (hydrochloride) for treatment of pain and opioid-induced constipation","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/829309/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-hydromorphone-hydrochloride-naloxone-hydrochloride-treatment-pain-opioid-induced-constipation_en.pdf"},
    {"id":"34217","name":"Public summary of the evaluation of a proposed product-specific waiver: Enclomifene for the treatment of hypogonadotropic hypogonadism","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/662484/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-enclomifene-treatment-hypogonadotropic-hypogonadism_en.pdf"},
    {"id":"12748","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Peanut flour for treatment of peanut allergy","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/787234/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-peanut-flour-treatment-peanut-allergy_en.pdf"},
    {"id":"3054","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Nintedanib for the treatment of systemic sclerosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/481785/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-nintedanib-treatment-systemic-sclerosis_en.pdf"},
    {"id":"42039","name":"Public summary of the evaluation of a proposed product-specific waiver: RoActemra (tocilizumab) for treatment of vasculitides","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/566826/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-roactemra-tocilizumab-treatment-vasculitides_en.pdf"},
    {"id":"6851","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Human immunoglobulin G2Lambda monoclonal antibody directed against thymic stromal lymphopoietin (MEDI9929) for the treatment of asthma","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-02-17T12:30:00Z","last_updated_date":"2015-02-17T12:30:00Z","reference_number":"EMA/66137/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-human-immunoglobulin-g2lambda-monoclonal-antibody-directed-against-thymic-stromal-lymphopoietin-medi9929-treatment-asthma_en.pdf"},
    {"id":"36038","name":"Public summary of the evaluation of a proposed product-specific waiver: Dupilumab for treatment of atopic dermatitis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/422641/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-dupilumab-treatment-atopic-dermatitis_en.pdf"},
    {"id":"15613","name":"Public summary of the evaluation of a proposed product-specific waiver: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxami...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/405832/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-1-22-difluoro-13-benzodioxol-5-yl-n-1-2r-23-dihydroxypropyl-6-fluoro-2-1-hydroxy-2-methylpropan-2-yl-1h-indol-5-ylcyclopropanecarboxami_en.pdf"},
    {"id":"24374","name":"Public summary of the evaluation of a proposed product-specific waiver:  Sofosbuvir / GS-5816 (a derivative of (S)-methyl (2-(2-(1H-imidazol-2-yl)pyrrolidin-1-yl)-2-oxoethyl)carbamate)) for the treatment of chronic hepat...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-08-20T12:00:00Z","last_updated_date":"2015-08-20T12:00:00Z","reference_number":"EMA/76260/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-sofosbuvir-gs-5816-derivative-s-methyl-2-2-1h-imidazol-2-ylpyrrolidin-1-yl-2-oxoethylcarbamate-treatment-chronic-hepat_en.pdf"},
    {"id":"25821","name":"Public summary of the evaluation of a proposed product-specific waiver:  Dapagliflozin for treatment of type 1 diabetes mellitus","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-07-06T12:30:00Z","last_updated_date":"2015-07-06T12:30:00Z","reference_number":"EMA/128725/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-dapagliflozin-treatment-type-1-diabetes-mellitus_en.pdf"},
    {"id":"27901","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Emtricitabine / tenofovir disoproxil fumarate (Truvada) for the treatment of human immunodeficiency virus (HIV-1) infection and for the preven...","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2016-07-11T16:00:00Z","last_updated_date":"2016-07-11T16:00:00Z","reference_number":"EMA/755069/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-emtricitabine-tenofovir-disoproxil-fumarate-truvada-treatment-human-immunodeficiency-virus-hiv-1-infection-preven_en.pdf"},
    {"id":"31306","name":"Public summary of the evaluation of a proposed paediatric investigation plan: Ozanimod for treatment of multiple sclerosis","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/781922/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-paediatric-investigation-plan-ozanimod-treatment-multiple-sclerosis_en.pdf"},
    {"id":"38421","name":"Public summary of the evaluation of a proposed product-specific waiver: Peanut allergen extract for treatment of peanut allergy","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/474696/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-peanut-allergen-extract-treatment-peanut-allergy_en.pdf"},
    {"id":"41105","name":"Public summary of the evaluation of a proposed product-specific waiver: Mirabegron for the treatment of neurogenic detrusor overactivity","type":"pip-summary","status":"unknown","consultation_date":"","first_published_date":"2015-09-02T02:00:00Z","last_updated_date":"2015-09-02T02:00:00Z","reference_number":"EMA/501567/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-summary/public-summary-evaluation-proposed-product-specific-waiver-mirabegron-treatment-neurogenic-detrusor-overactivity_en.pdf"},
    {"id":"65924","name":"Presentation - Case study: Fondazione Telethon (C.Scotti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:45:50Z","last_updated_date":"2024-12-03T14:45:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-fondazione-telethon-cscotti_en.pdf"},
    {"id":"65925","name":"Presentation - Case study: Holoclar (M.Latella, Holostem)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:47:03Z","last_updated_date":"2024-12-03T14:47:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-holoclar-mlatella-holostem_en.pdf"},
    {"id":"65926","name":"Report - EU NTC ten year anniversary event","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:47:15Z","last_updated_date":"2024-12-03T14:47:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/report-eu-ntc-ten-year-anniversary-event_en.pdf"},
    {"id":"65928","name":"Presentation - Round Table discussion: Academia no-profit perspective (G.Calvo, Hospital Clinic de Barcelona)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:50:00Z","last_updated_date":"2024-12-03T14:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-round-table-discussion-academia-no-profit-perspective-gcalvo-hospital-clinic-de-barcelona_en.pdf"},
    {"id":"65929","name":"Presentation - Round Table discussion: Academia no-profit perspective (A.Biondi, University of Milan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:50:59Z","last_updated_date":"2024-12-03T14:50:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-round-table-discussion-academia-no-profit-perspective-abiondi-university-milan_en.pdf"},
    {"id":"65930","name":"Presentation - Round Table discussion: Academia no-profit perspective (A.Aiuti, San Raffaele Telethon Institute for Gene Therapy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:51:39Z","last_updated_date":"2024-12-03T14:51:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-round-table-discussion-academia-no-profit-perspective-aaiuti-san-raffaele-telethon-institute-gene-therapy_en.pdf"},
    {"id":"65931","name":"Presentation - Round Table discussion: Industry perspective (R.Ena, Federchimica Assobiotec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:52:41Z","last_updated_date":"2024-12-03T14:52:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-round-table-discussion-industry-perspective-rena-federchimica-assobiotec_en.pdf"},
    {"id":"65927","name":"Presentation - Round Table discussion: Main factors affecting development and access to ATMPs in the EU","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T14:48:01Z","last_updated_date":"2024-12-03T14:48:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-round-table-discussion-main-factors-affecting-development-access-atmps-eu_en.pdf"},
    {"id":"31586","name":"Pediatric Cluster Terms of Reference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2007-06-18T02:09:00Z","last_updated_date":"2024-12-03T16:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pediatric-cluster-terms-reference_en.pdf"},
    {"id":"63653","name":"Medicine shortage prevention plan - template","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T13:57:00Z","last_updated_date":"2024-12-04T11:34:00Z","reference_number":"EMA/549304/2023","document_url":"https://www.ema.europa.eu/en/documents/other/medicine-shortage-prevention-plan-template_en.pdf"},
    {"id":"63654","name":"Medicine shortage mitigation plan - template","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T13:58:00Z","last_updated_date":"2024-12-04T11:35:00Z","reference_number":"EMA/549303/2023","document_url":"https://www.ema.europa.eu/en/documents/other/medicine-shortage-mitigation-plan-template_en.pdf"},
    {"id":"65939","name":"Guideline on the clinical requirements for non-replacement therapy in haemophilia A and B","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-12-04T11:33:10Z","last_updated_date":"2024-12-04T11:33:10Z","reference_number":"EMA/CHMP/BPWP/518080/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-requirements-non-replacement-therapy-haemophilia-b_en.pdf"},
    {"id":"65950","name":"Agenda - Seventh European Medicines Agency (EMA) EFPIA bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-12-04T15:22:47Z","last_updated_date":"2024-12-04T15:22:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-seventh-european-medicines-agency-ema-efpia-bilateral-meeting_en.pdf"},
    {"id":"65955","name":"Template to report an allegation concerning breaches in an area of EMA’s responsibility (authorisation, supervision and maintenance of human and veterinary medicinal products)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:08:38Z","last_updated_date":"2024-12-05T10:08:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-report-allegation-concerning-breaches-area-emas-responsibility-authorisation-supervision-maintenance-human-veterinary-medicinal-products_en.docx"},
    {"id":"65957","name":"Presentation - DARWIN EU: How is RWE transforming regulatory decision making? (A. Segec) ","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:35:08Z","last_updated_date":"2024-12-05T10:35:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-darwin-eu-how-rwe-transforming-regulatory-decision-making-segec_en.pdf"},
    {"id":"65958","name":"Presentation - Agreed approach post section 6 pilot for PSUSA ( M. Escudeiro Dos Santos, B. Pelle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:38:13Z","last_updated_date":"2024-12-05T10:38:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agreed-approach-post-section-6-pilot-psusa-m-escudeiro-dos-santos-b-pelle_en.pdf"},
    {"id":"65959","name":"Presentation - An agency of the European Union PSUR frequencies for active substances with DLP 2025 based on a risk-based approach (M. López Fauqued)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:43:43Z","last_updated_date":"2024-12-05T10:43:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agency-european-union-psur-frequencies-active-substances-dlp-2025-based-risk-based-approach-m-lopez-fauqued_en.pdf"},
    {"id":"65960","name":"Presentation - Revision of Guideline on Risk assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling (D. Duarte)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:45:29Z","last_updated_date":"2024-12-05T10:45:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-revision-guideline-risk-assessment-medicinal-products-human-reproduction-lactation-data-labelling-d-duarte_en.pdf"},
    {"id":"65962","name":"Presentation - Update on Good Pharmacovigilance Practices (EU-GVP) (P. Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:46:57Z","last_updated_date":"2024-12-05T10:46:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-good-pharmacovigilance-practices-eu-gvp-p-bahri_en.pdf"},
    {"id":"65963","name":"Presentation - An agency of the European Union AI in pharmacovigilance –  EMA update ( J. Durand, L. Pinheiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:48:15Z","last_updated_date":"2024-12-05T10:48:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-agency-european-union-ai-pharmacovigilance-ema-update-j-durand-l-pinheiro_en.pdf"},
    {"id":"65964","name":"Presentation - EudraVigilance - Masking Policy of Personal Data (R. Postigo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:50:18Z","last_updated_date":"2024-12-05T10:50:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eudravigilance-masking-policy-personal-data-r-postigo_en.pdf"},
    {"id":"65965","name":"Presentation - Industry platform meeting -operation of EU pharmacovigilance (M. Rivera Vargas, P. Lopez Fernandez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T10:52:01Z","last_updated_date":"2024-12-05T10:52:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-platform-meeting-operation-eu-pharmacovigilance-m-rivera-vargas-p-lopez-fernandez_en.pdf"},
    {"id":"23366","name":"Guidance for applicants seeking scientific support and advice on traditional herbal medicinal products","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"2011-07-12 - 2011-11-15","first_published_date":"2011-07-20T04:00:00Z","last_updated_date":"2024-12-05T13:20:00Z","reference_number":"EMA/HMPC/127670/2011 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-applicants-seeking-scientific-support-advice-traditional-herbal-medicinal-products_en.pdf"},
    {"id":"65974","name":"Presentation - Submission of Manufacturers, Manufacturing Business Operations and structured pack size data to Product Management Service (M. Gomez, V. di Paola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T13:51:52Z","last_updated_date":"2024-12-05T13:51:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-submission-manufacturers-manufacturing-business-operations-structured-pack-size-data-product-management-service-m-gomez-v-di-paola_en.pdf"},
    {"id":"63588","name":"Agenda - Workshop on the challenges in drug development, regulation and clinical practice in haemoglobinopathies","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-06-12T14:51:43Z","last_updated_date":"2024-06-12T14:51:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-workshop-challenges-drug-development-regulation-clinical-practice-haemoglobinopathies_en.pdf"},
    {"id":"65975","name":"Meeting report - Workshop on the challenges in drug development, regulation and clinical practice in haemoglobinopathies","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T13:54:55Z","last_updated_date":"2024-12-05T13:54:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-workshop-challenges-drug-development-regulation-clinical-practice-haemoglobinopathies_en.pdf"},
    {"id":"65977","name":"Presentation - Volume of sales data submission: Refresher webinar for the veterinary industry","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T13:57:52Z","last_updated_date":"2024-12-05T13:57:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-volume-sales-data-submission-refresher-webinar-veterinary-industry_en.pdf"},
    {"id":"65985","name":"Direct healthcare professional communication (DHPC): Ibandronic acid Accord solution for injection 3 mg/3ml in pre-filled syringe (ibandronic acid) - product packaging issues (injection needle having a shorter expiration date than the product shelf-life)","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T15:30:44Z","last_updated_date":"2024-12-05T15:30:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-ibandronic-acid-accord-solution-injection-3-mg-3ml-pre-filled-syringe-ibandronic-acid-product-packaging-issues-injection-needle-having-shorter_en.pdf"},
    {"id":"65987","name":"Presentation - European PaediatricTranslational Research Infrastructure (EPTRI) (D.Bonifazi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:27:45Z","last_updated_date":"2024-12-05T16:27:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-paediatrictranslational-research-infrastructure-eptri-dbonifazi_en.pdf"},
    {"id":"65979","name":"Presentation - Language discrimination and cross border access to paediatric clinical trials working group (B.Nafria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:08:47Z","last_updated_date":"2024-12-05T14:08:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-language-discrimination-cross-border-access-paediatric-clinical-trials-working-group-bnafria_en.pdf"},
    {"id":"65989","name":"Presentation - Brief update: Reform of the EU pharmaceutical legislation (G. Egger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:40:14Z","last_updated_date":"2024-12-05T16:40:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-brief-update-reform-eu-pharmaceutical-legislation-g-egger_en.pdf"},
    {"id":"65990","name":"Presentation - The COMBINE project: Interface between medicines and medicinal products (M. Lunzer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:43:46Z","last_updated_date":"2024-12-05T16:43:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-combine-project-interface-between-medicines-medicinal-products-m-lunzer_en.pdf"},
    {"id":"65991","name":"Presentation - Update on CTR implementation, including new CTIS transparency rules (F. Scotti, L. Pioppo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:45:53Z","last_updated_date":"2024-12-05T16:45:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ctr-implementation-including-new-ctis-transparency-rules-f-scotti-l-pioppo_en.pdf"},
    {"id":"65992","name":"Presentation - 2.5 years of CTR and CTIS: Experiences from Academic Sponsor Institutions in the ITCC network (A. Elsinghorst)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:47:16Z","last_updated_date":"2024-12-05T16:47:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-25-years-ctr-ctis-experiences-academic-sponsor-institutions-itcc-network-elsinghorst_en.pdf"},
    {"id":"65994","name":"Presentation - Non-oncological MoA based PIP – Initial Deliberations from the PDCO working group discussions (S. Scherer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:51:38Z","last_updated_date":"2024-12-05T16:51:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-non-oncological-moa-based-pip-initial-deliberations-pdco-working-group-discussions-s-scherer_en.pdf"},
    {"id":"65996","name":"Presentation - Emerging ethics assessment challenges in paediatric clinical trials and revision of declaration of Helsinki - What will change? (M. A. Ribeiro)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:56:05Z","last_updated_date":"2024-12-05T16:56:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emerging-ethics-assessment-challenges-paediatric-clinical-trials-revision-declaration-helsinki-what-will-change-m-ribeiro_en.pdf"},
    {"id":"65997","name":"Presentation - Enpr-EMA Annual Report 2023-2024 (P. Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:58:46Z","last_updated_date":"2024-12-05T16:58:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-annual-report-2023-2024-p-lepola_en.pdf"},
    {"id":"65995","name":"Presentation - PDCO update for Enpr-EMA (S. Benchetrit)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:54:27Z","last_updated_date":"2024-12-05T16:54:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-update-enpr-ema-s-benchetrit_en.pdf"},
    {"id":"66000","name":"Presentation - Language discrimination and cross border access to paediatric clinical trials - working group (B. Nafria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T17:03:01Z","last_updated_date":"2024-12-05T17:03:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-language-discrimination-cross-border-access-paediatric-clinical-trials-working-group-b-nafria_en.pdf"},
    {"id":"66001","name":"Presentation - Conect4children (c4c) stichting - From IHI initiative to sustainable paediatric research infrastructure (M. Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T17:05:20Z","last_updated_date":"2024-12-05T17:05:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-conect4children-c4c-stichting-ihi-initiative-sustainable-paediatric-research-infrastructure-m-turner_en.pdf"},
    {"id":"66002","name":"Presentation - How can academia build capacity to optimise RWD collection in order to support health technology assessment in paediatrics (D. Umuhire, K. Pleuschke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T17:07:30Z","last_updated_date":"2024-12-05T17:07:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-can-academia-build-capacity-optimise-rwd-collection-order-support-health-technology-assessment-paediatrics-d-umuhire-k-pleuschke_en.pdf"},
    {"id":"66004","name":"Example - production release version 1.7.2443 December 2024 - Veterinary Medicinal Products Regulation: Union Product Database","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T17:20:06Z","last_updated_date":"2024-12-05T17:20:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/example-production-release-version-172443-december-2024-veterinary-medicinal-products-regulation-union-product-database_en.zip"},
    {"id":"65999","name":"Presentation - Quality criteria for paediatric clinical trial sites – an Enpr-EMA initiative (R. Fernandes, P. Skovby)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T17:00:05Z","last_updated_date":"2024-12-05T17:00:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-criteria-paediatric-clinical-trial-sites-enpr-ema-initiative-r-fernandes-p-skovby_en.pdf"},
    {"id":"65978","name":"Presentation - Quality criteria for paediatric clinical trial sites - an Enpr-EMA initiative (R.Fernandez, P.Skovby)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:03:44Z","last_updated_date":"2024-12-05T14:03:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-criteria-paediatric-clinical-trial-sites-enpr-ema-initiative-rfernandez-pskovby_en.pdf"},
    {"id":"65980","name":"Presentation - Patient and Public Involvement (PPI) working group (S.Gaillard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:11:35Z","last_updated_date":"2024-12-05T14:11:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-public-involvement-ppi-working-group-sgaillard_en.pdf"},
    {"id":"65981","name":"Presentation - Enpr-EMA- Paediatric Research Nurse Working Group (P.Dicks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:12:47Z","last_updated_date":"2024-12-05T14:12:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-paediatric-research-nurse-working-group-pdicks_en.pdf"},
    {"id":"65982","name":"Presentation - Enpr-EMA activities, proposals for 2024-2025 (P.Lepola, G.Egger)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:13:44Z","last_updated_date":"2024-12-05T14:13:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-activities-proposals-2024-2025-plepola-gegger_en.pdf"},
    {"id":"65983","name":"Presentation - Further development of Enpr-EMA (P.Lepola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:23:07Z","last_updated_date":"2024-12-05T14:23:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-further-development-enpr-ema-plepola_en.pdf"},
    {"id":"65984","name":"Presentation - The connect4children paediatric data harmonisation journey (R.Leary)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T14:24:42Z","last_updated_date":"2024-12-05T14:24:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-connect4children-paediatric-data-harmonisation-journey-rleary_en.pdf"},
    {"id":"65986","name":"Presentation - Reflections on the concept of a facilitation framework (D.Karres)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:26:47Z","last_updated_date":"2024-12-05T16:26:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reflections-concept-facilitation-framework-dkarres_en.pdf"},
    {"id":"65988","name":"Presentation - OrphaDev4Kids (M.Migdal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-05T16:29:14Z","last_updated_date":"2024-12-05T16:29:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-orphadev4kids-mmigdal_en.pdf"},
    {"id":"65944","name":"User manual: AIM-NASH algorithm for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-06T12:00:00Z","last_updated_date":"2024-12-06T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/user-manual-aim-nash-algorithm-artificial-intelligence-based-measurement-non-alcoholic-steatohepatitis-histology_en.pdf"},
    {"id":"65946","name":"Briefing book: AI-based histologic measurement of NASH (AIM-NASH)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-06T12:00:00Z","last_updated_date":"2024-12-06T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/briefing-book-ai-based-histologic-measurement-nash-aim-nash_en.pdf"},
    {"id":"65947","name":"Written responses to first list of Issues for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology (AIM-NASH) tool","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-06T12:00:00Z","last_updated_date":"2024-12-06T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/written-responses-first-list-issues-artificial-intelligence-based-measurement-non-alcoholic-steatohepatitis-histology-aim-nash-tool_en.pdf"},
    {"id":"65948","name":"Written responses to second list of Issues for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology (AIM-NASH) tool","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-06T12:00:00Z","last_updated_date":"2024-12-06T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/written-responses-second-list-issues-artificial-intelligence-based-measurement-non-alcoholic-steatohepatitis-histology-aim-nash-tool_en.pdf"},
    {"id":"65577","name":"CVMP summary of positive opinion for Carprofen Orion","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-11-08T12:45:18Z","last_updated_date":"2024-11-08T12:45:18Z","reference_number":"EMA/CVMP/490426/2024 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-carprofen-orion_en.pdf"},
    {"id":"46545","name":"Record of data processing activity for the Experts Management Tool and the handling of competing interests","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-01-24T14:22:00Z","last_updated_date":"2024-12-03T11:11:00Z","reference_number":"EMA/283093/2023","document_url":"https://www.ema.europa.eu/en/documents/other/record-data-processing-activity-experts-management-tool-handling-competing-interests_en.pdf"},
    {"id":"66007","name":"CVMP summary of positive opinion for Icthiovac ERM","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-12-06T12:11:04Z","last_updated_date":"2024-12-06T12:11:04Z","reference_number":"EMA/CVMP/536281/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-icthiovac-erm_en.pdf"},
    {"id":"66008","name":"CVMP summary of positive opinion for Tolfenamic acid VMD","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-12-06T12:14:45Z","last_updated_date":"2024-12-06T12:14:45Z","reference_number":"EMA/CVMP/543175/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-tolfenamic-acid-vmd_en.pdf"},
    {"id":"66009","name":"CVMP summary of positive opinion for Poulvac Procerta HVT-IBD-ND","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-12-06T12:16:34Z","last_updated_date":"2024-12-06T12:16:34Z","reference_number":"EMA/CVMP/442900/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-poulvac-procerta-hvt-ibd-nd_en.pdf"},
    {"id":"66011","name":"Metamizole-containing medicinal products article 107i referral - Divergent positions to CMDh position","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2024-12-06T16:18:01Z","last_updated_date":"2024-12-06T16:18:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107i-referral-divergent-positions-cmdh-position_en.pdf"},
    {"id":"66012","name":"Metamizole-containing medicinal products article 107i referral - Assessment report","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2024-12-06T16:19:23Z","last_updated_date":"2024-12-06T16:19:23Z","reference_number":"EMA/470471/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/metamizole-containing-medicinal-products-article-107i-referral-assessment-report_en.pdf"},
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    {"id":"66020","name":"Letter of Support for intermediate Age-Related Macular Degeneration (AMD) biomarker and novel clinical endpoint development","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-09T14:19:18Z","last_updated_date":"2024-12-09T14:19:18Z","reference_number":"EMADOC-1700519818-1790091","document_url":"https://www.ema.europa.eu/en/documents/other/letter-support-intermediate-age-related-macular-degeneration-amd-biomarker-novel-clinical-endpoint-development_en.pdf"},
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    {"id":"66028","name":"Annual report of the Good Clinical Practice Inspectors Working Group 2023","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-12-09T15:55:47Z","last_updated_date":"2024-12-09T15:55:47Z","reference_number":"EMA/INS/GCP/164938/2024","document_url":"https://www.ema.europa.eu/en/documents/report/annual-report-good-clinical-practice-inspectors-working-group-2023_en.pdf"},
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    {"id":"61739","name":"Annual report of the Good Clinical Practice Inspectors Working Group 2022","type":"annual-report","status":"Adopted","consultation_date":"","first_published_date":"2024-01-11T15:16:27Z","last_updated_date":"2024-01-11T15:16:27Z","reference_number":"EMA/INS/GCP/126568/2023","document_url":"https://www.ema.europa.eu/en/documents/annual-report/annual-report-good-clinical-practice-inspectors-working-group-2022_en.pdf"},
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    {"id":"34582","name":"Medicinal products for human use: Monthly figures - January 2011","type":"report","status":"unknown","consultation_date":"","first_published_date":"2011-03-02T01:00:00Z","last_updated_date":"2011-03-02T01:00:00Z","reference_number":"EMA/148620/2011","document_url":"https://www.ema.europa.eu/en/documents/report/medicinal-products-human-use-monthly-figures-january-2011_en.pdf"},
    {"id":"54163","name":"Medicinal products for human use: monthly figures - December 2021","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-02-15T10:29:00Z","last_updated_date":"2022-02-15T10:29:00Z","reference_number":"EMA/14975/2022","document_url":"https://www.ema.europa.eu/en/documents/report/medicinal-products-human-use-monthly-figures-december-2021_en.pdf"},
    {"id":"41810","name":"Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-04-30T13:33:00Z","last_updated_date":"2024-12-13T14:22:00Z","reference_number":"EMA/CVMP/ERA/103555/2015 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-assessing-environmental-human-health-risks-veterinary-medicinal-products-groundwater_en.pdf"},
    {"id":"50660","name":"Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2021-03-22T09:55:00Z","last_updated_date":"2024-12-13T14:22:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/pre-submission-request-form-european-medicines-agency-veterinary-medicinal-product-accordance-regulation-eu-2019-6_en.docx"},
    {"id":"66120","name":"Work plan for the Committee for Veterinary Medicinal Products (CVMP) Antimicrobials Working Party (AWP) 2025","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2024-12-13T14:45:00Z","last_updated_date":"2024-12-13T14:45:00Z","reference_number":"EMA/CVMP/AWP/341740/2024","document_url":"https://www.ema.europa.eu/en/documents/work-programme/work-plan-committee-veterinary-medicinal-products-cvmp-antimicrobials-working-party-awp-2025_en.pdf"},
    {"id":"66119","name":"Minutes - HMA-EMA joint Big Data Steering Group teleconference - 15 November 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2024-12-13T14:41:47Z","last_updated_date":"2024-12-13T14:41:47Z","reference_number":"EMA/548191/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-hma-ema-joint-big-data-steering-group-teleconference-15-november-2024_en.pdf"},
    {"id":"66121","name":"Highlight report - Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-12-13T15:01:00Z","last_updated_date":"2024-12-13T15:01:00Z","reference_number":"EMA/544205/2024","document_url":"https://www.ema.europa.eu/en/documents/report/highlight-report-thirteenth-meeting-industry-stakeholder-platform-operation-centralised-procedure-human-medicines_en.pdf"},
    {"id":"5564","name":"PRAC advice template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2017-08-04T15:00:00Z","last_updated_date":"2024-12-13T14:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/prac-advice-template_en.doc"},
    {"id":"62028","name":"Mandate, objectives, and rules of procedure for the European Specialised Expert Community (ESEC) for Methodology","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-02-14T16:36:27Z","last_updated_date":"2024-12-13T15:16:00Z","reference_number":"EMA/125839/2023","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-rules-procedure-european-specialised-expert-community-esec-methodology_en.pdf"},
    {"id":"66123","name":"Overview of comments received on Guideline on live recombinant vector vaccines for veterinary use - Revision 1","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2024-12-13T16:12:12Z","last_updated_date":"2024-12-13T16:12:12Z","reference_number":"EMA/260063/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-guideline-live-recombinant-vector-vaccines-veterinary-use-revision-1_en.pdf"},
    {"id":"66124","name":"Guideline on live recombinant vector vaccines for veterinary use - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-12-13T16:13:31Z","last_updated_date":"2024-12-13T16:13:31Z","reference_number":"EMA/CVMP/IWP/390313/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-live-recombinant-vector-vaccines-veterinary-use-revision-1_en.pdf"},
    {"id":"66098","name":"CHMP summary of positive opinion for Seladelpar Gilead","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-12-13T09:14:21Z","last_updated_date":"2024-12-13T16:47:14Z","reference_number":"EMA/CHMP/548691/2024 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-seladelpar-gilead_en.pdf"},
    {"id":"66135","name":"Declaration of interest: Olivier Simoen","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:24:54Z","last_updated_date":"2024-12-16T11:24:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interest-olivier-simoen_en.pdf"},
    {"id":"66151","name":"Presentation - Network data strategy interplay with EHDS (D. Asturiol)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:34:57Z","last_updated_date":"2024-12-16T12:34:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-network-data-strategy-interplay-ehds-d-asturiol_en.pdf"},
    {"id":"66152","name":"Presentation - Ethical challenges for EMRN network strategy (A. Cambon-Thomsen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:37:09Z","last_updated_date":"2024-12-16T12:37:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ethical-challenges-emrn-network-strategy-cambon-thomsen_en.pdf"},
    {"id":"66153","name":"Presentation - Value of data: what’s standards contribution? (C. Hay)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:39:19Z","last_updated_date":"2024-12-16T12:39:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-value-data-whats-standards-contribution-c-hay_en.pdf"},
    {"id":"66150","name":"Presentation - Network data strategy: data quality management & interoperability (I. Chicharo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:32:46Z","last_updated_date":"2024-12-16T12:32:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-network-data-strategy-data-quality-management-interoperability-i-chicharo_en.pdf"},
    {"id":"66149","name":"Presentation - Network data strategy: data governance, data cataloguing and metadata management (H-J Bigalke)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:12:37Z","last_updated_date":"2024-12-16T12:12:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-network-data-strategy-data-governance-data-cataloguing-metadata-management-h-j-bigalke_en.pdf"},
    {"id":"66148","name":"Presentation - Building a unified Network data strategy for operational excellence (G. Neuwirther)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:09:57Z","last_updated_date":"2024-12-16T12:09:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-building-unified-network-data-strategy-operational-excellence-g-neuwirther_en.pdf"},
    {"id":"66147","name":"Presentation - Network data strategy: analysis of data and use of tools, knowledge and change management (K. Aasen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:07:46Z","last_updated_date":"2024-12-16T12:07:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-network-data-strategy-analysis-data-use-tools-knowledge-change-management-k-aasen_en.pdf"},
    {"id":"66146","name":"Presentation - Unlocking the potential of mHealth data for evidence generation (D. Umuhire)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T12:00:19Z","last_updated_date":"2024-12-16T12:00:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-unlocking-potential-mhealth-data-evidence-generation-d-umuhire_en.pdf"},
    {"id":"66145","name":"Presentation - Leveraging data through technology & digitalisation (C. Torre)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:58:45Z","last_updated_date":"2024-12-16T11:58:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-leveraging-data-through-technology-digitalisation-c-torre_en.pdf"},
    {"id":"66144","name":"Presentation - Evidence generation to advance regulatory excellence, preparing for tomorrow (L. Ishihara)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:55:30Z","last_updated_date":"2024-12-16T11:55:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-evidence-generation-advance-regulatory-excellence-preparing-tomorrow-l-ishihara_en.pdf"},
    {"id":"66143","name":"Presentation - Anchoring ethics at all steps (A. Cambon-Thomsen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:51:18Z","last_updated_date":"2024-12-16T11:51:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-anchoring-ethics-all-steps-cambon-thomsen_en.pdf"},
    {"id":"66142","name":"Presentation - Harnessing the value of genomic data for evidence generation (J. Mwinyi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:49:18Z","last_updated_date":"2024-12-16T11:49:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-harnessing-value-genomic-data-evidence-generation-j-mwinyi_en.pdf"},
    {"id":"66141","name":"Presentation - Can social media data be used to support evidence generation? (E. Agricola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:47:37Z","last_updated_date":"2024-12-16T11:47:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-can-social-media-data-be-used-support-evidence-generation-e-agricola_en.pdf"},
    {"id":"66140","name":"Presentation - Seeing the totality of evidence generation (B. Sepodes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:37:55Z","last_updated_date":"2024-12-16T11:37:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-seeing-totality-evidence-generation-b-sepodes_en.pdf"},
    {"id":"66139","name":"Presentation - Multilingual and open Sourced - a new chapter for statistical programming in pharma (J-P. Perttola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:35:46Z","last_updated_date":"2024-12-16T11:35:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multilingual-open-sourced-new-chapter-statistical-programming-pharma-j-p-perttola_en.pdf"},
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    {"id":"66137","name":"Presentation - RWD in the context of clinical trials – from pilots to practice (M. Zuidgeest)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:30:05Z","last_updated_date":"2024-12-16T11:30:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-rwd-context-clinical-trials-pilots-practice-m-zuidgeest_en.pdf"},
    {"id":"66136","name":"Presentation - International collaboration progress (M. Kampman)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:17:02Z","last_updated_date":"2024-12-16T11:17:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-international-collaboration-progress-m-kampman_en.pdf"},
    {"id":"66134","name":"Presentation - Clinical study data pilot – interim results and learnings (F. Klinglmueller)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:13:18Z","last_updated_date":"2024-12-16T11:13:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-study-data-pilot-interim-results-learnings-f-klinglmueller_en.pdf"},
    {"id":"66133","name":"Presentation - Analysis of real world data to support regulatory decision-making (P. McGettigan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T11:09:29Z","last_updated_date":"2024-12-16T11:09:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-analysis-real-world-data-support-regulatory-decision-making-p-mcgettigan_en.pdf"},
    {"id":"66132","name":"Presentation - Veterinary big data strategy update (P. Damien Lynn, S. Bertulat)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T10:51:50Z","last_updated_date":"2024-12-16T10:51:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-big-data-strategy-update-p-damien-lynn-s-bertulat_en.pdf"},
    {"id":"66131","name":"Presentation - Reflections on EMA data workplan: learnings and priorities for the future (J. Wang-Silvanto)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T10:46:12Z","last_updated_date":"2024-12-16T10:46:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reflections-ema-data-workplan-learnings-priorities-future-j-wang-silvanto_en.pdf"},
    {"id":"66127","name":"Presentation - 5th year into our journey to data driven medicines regulation (P. Arlett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T10:30:08Z","last_updated_date":"2024-12-16T10:30:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-5th-year-our-journey-data-driven-medicines-regulation-p-arlett_en.pdf"},
    {"id":"66130","name":"Presentation - Implementation of the HMA/EMA Big Data Task Force priority recommendations (C. Thomassin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T10:44:17Z","last_updated_date":"2024-12-16T10:44:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-hma-ema-big-data-task-force-priority-recommendations-c-thomassin_en.pdf"},
    {"id":"66128","name":"Presentation - Implementation of the HMA/EMA Big Data Task Force priority recommendations (H. Gardarsdottir)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T10:36:23Z","last_updated_date":"2024-12-16T10:36:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-hma-ema-big-data-task-force-priority-recommendations-h-gardarsdottir_en.pdf"},
    {"id":"66104","name":"Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T14:00:00Z","last_updated_date":"2024-12-16T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/electronic-product-information-epi-report-experience-gained-creation-epi-during-regulatory-procedures-eu-human-medicines_en.pdf"},
    {"id":"64956","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Durysta (bimatoprost intracameral implant)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2024-09-20T11:11:11Z","last_updated_date":"2024-12-16T15:01:24Z","reference_number":"EMA/433446/2024","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-durysta-bimatoprost-intracameral-implant_sv.pdf"}},
    {"id":"66158","name":"Direct healthcare professional communication (DHPC): Medroxyprogesterone-containing medicines: Risk of meningioma and measures to minimise this risk ","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T15:46:06Z","last_updated_date":"2024-12-16T15:46:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-medroxyprogesterone-containing-medicines-risk-meningioma-measures-minimise-risk_en.pdf"},
    {"id":"66163","name":"Big Data Steering Group (BDSG): 2024 report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-12-16T16:26:04Z","last_updated_date":"2024-12-16T16:26:04Z","reference_number":"EMA/471579/2024","document_url":"https://www.ema.europa.eu/en/documents/report/big-data-steering-group-bdsg-2024-report_en.pdf"},
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    {"id":"26301","name":"Croatia - Agency for Medicinal Products and Medical Devices, S Tomic","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/croatia-agency-medicinal-products-medical-devices-s-tomic_en.pdf"},
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    {"id":"9110","name":"Opinions on consultation procedures on ancillary medicinal substances in medical devices - CHMP meeting 18-21 February 2013","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2013-02-22T13:00:00Z","last_updated_date":"2013-02-22T13:00:00Z","reference_number":"EMA/116578/2013","document_url":"https://www.ema.europa.eu/en/documents/other/opinions-consultation-procedures-ancillary-medicinal-substances-medical-devices-chmp-meeting-18-21-february-2013_en.pdf"},
    {"id":"11599","name":"Report on interactions between the Japanese Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency and the European Medicines Agency","type":"report","status":"unknown","consultation_date":"","first_published_date":"2012-07-30T12:33:37Z","last_updated_date":"2012-07-30T12:33:37Z","reference_number":"EMA/436043/2012","document_url":"https://www.ema.europa.eu/en/documents/report/report-interactions-between-japanese-ministry-health-labour-welfare-pharmaceuticals-medical-devices-agency-european-medicines-agency_en.pdf"},
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    {"id":"5100","name":"Renewal of confidentiality arrangement: Letter from Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to European Commission and European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-07T12:00:00Z","last_updated_date":"2013-02-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/renewal-confidentiality-arrangement-letter-ministry-health-labour-welfare-pharmaceuticals-medical-devices-agency-european-commission-european-medicines-agency_en.pdf"},
    {"id":"7868","name":"Renewal of confidentiality arrangement: Letter from European Commission and European Medicines Agency to Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-02-07T12:00:00Z","last_updated_date":"2013-02-07T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/renewal-confidentiality-arrangement-letter-european-commission-european-medicines-agency-ministry-health-labour-welfare-pharmaceuticals-medical-devices-agency_en.pdf"},
    {"id":"12273","name":"Mandate, objectives and rules of procedure for the EMA/CAT and Medical Devices’ Notified Body (EMA/CATNB) Collaboration Group (CG)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2010-12-06T01:00:00Z","last_updated_date":"2010-12-06T01:00:00Z","reference_number":"EMA/327938/2010","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-rules-procedure-ema-cat-medical-devices-notified-body-ema-catnb-collaboration-group-cg_en.pdf"},
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    {"id":"28401","name":"Renewal of confidentiality arrangement: Main letter from Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to European Commission and European Medicines Agency","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-03-07T14:00:00Z","last_updated_date":"2013-03-07T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/renewal-confidentiality-arrangement-main-letter-ministry-health-labour-welfare-pharmaceuticals-medical-devices-agency-european-commission-european-medicines-agency_en.pdf"},
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    {"id":"66684","name":"Addendum to Assessment report on Peumus boldus Molina, folium","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2025-02-11T16:29:17Z","last_updated_date":"2025-02-11T16:29:17Z","reference_number":"EMA/HMPC/329351/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-peumus-boldus-molina-folium_en.pdf"},
    {"id":"66689","name":"Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-02-12T09:25:14Z","last_updated_date":"2025-02-12T09:25:14Z","reference_number":"EMA/CHMP/518671/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/nilotinib-hard-capsules-50-150-200-mg-product-specific-bioequivalence-guidance_en.pdf-0"},
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    {"id":"66445","name":"Agenda - European medicines agencies network strategy (EMANS) to 2028 - webinar","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-01-24T12:20:44Z","last_updated_date":"2025-02-12T09:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agencies-network-strategy-emans-2028-webinar_en.pdf"},
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    {"id":"65752","name":"P/0410/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fitusiran (EMEA- 001855-PIP01-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T13:37:53Z","last_updated_date":"2024-11-21T13:37:53Z","reference_number":"EMA/429873/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0410-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-fitusiran-emea-001855-pip01-15-m05_en.pdf"},
    {"id":"65751","name":"P/0408/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for carfilzomib (Kyprolis), (EMEA-001806-PIP04-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T13:33:06Z","last_updated_date":"2024-11-21T13:33:06Z","reference_number":"EMA/429693/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0408-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-carfilzomib-kyprolis-emea-001806-pip04-19-m02_en.pdf"},
    {"id":"65750","name":"P/0400/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for evenamide (EMEA-002519-PIP03-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T11:56:53Z","last_updated_date":"2024-11-21T11:56:53Z","reference_number":"EMA/400402/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0400-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-evenamide-emea-002519-pip03-21-m01_en.pdf"},
    {"id":"65749","name":"P/0399/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for eptinezumab (Vyepti), (EMEA-002243-PIP01-17-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T11:41:38Z","last_updated_date":"2024-11-21T11:41:38Z","reference_number":"EMA/400367/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0399-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-eptinezumab-vyepti-emea-002243-pip01-17-m04_en.pdf"},
    {"id":"65748","name":"P/0398/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact), (EMEA-000332-PIP02-17-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T11:37:08Z","last_updated_date":"2024-11-21T11:37:08Z","reference_number":"EMA/400670/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0398-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-briviact-emea-000332-pip02-17-m05_en.pdf"},
    {"id":"65747","name":"P/0397/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for eravacycline (Xerava), (EMEA-001555-PIP01-13-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T11:25:27Z","last_updated_date":"2024-11-21T11:25:27Z","reference_number":"EMA/468349/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0397-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-eravacycline-xerava-emea-001555-pip01-13-m05_en.pdf"},
    {"id":"65746","name":"P/0396/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP02-13-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-21T11:21:01Z","last_updated_date":"2024-11-21T11:21:01Z","reference_number":"EMA/468097/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0396-2023-ema-decision-27-october-2023-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-dupixent-emea-001501-pip02-13-m08_en.pdf"},
    {"id":"65741","name":"P/0451/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for upadacitinib (Rinvoq), (EMEA-001741-PIP09-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T16:43:08Z","last_updated_date":"2024-11-20T16:43:08Z","reference_number":"EMA/481596/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0451-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-upadacitinib-rinvoq-emea-001741-pip09-23_en.pdf"},
    {"id":"65740","name":"P/0450/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iptacopan (EMEA-002705-PIP05-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T16:37:14Z","last_updated_date":"2024-11-20T16:37:14Z","reference_number":"EMA/481244/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0450-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-iptacopan-emea-002705-pip05-23_en.pdf"},
    {"id":"65738","name":"P/0446/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for upadacitinib (Rinvoq), (EMEA-001741-PIP08-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T16:31:58Z","last_updated_date":"2024-11-20T16:31:58Z","reference_number":"EMA/478348/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0446-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-waiver-upadacitinib-rinvoq-emea-001741-pip08-22_en.pdf"},
    {"id":"65737","name":"P/0445/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Neisseria meningitidis group A.....(MenPenta vaccine) (EMEA-003379-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T16:20:10Z","last_updated_date":"2024-11-20T16:20:10Z","reference_number":"EMA/470009/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0445-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-neisseria-meningitidis-group-amenpenta-vaccine-emea-003379-pip01-22_en.pdf"},
    {"id":"65736","name":"P/0444/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ruzotolimod, (EMEA-003363-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T16:10:59Z","last_updated_date":"2024-11-20T16:10:59Z","reference_number":"EMA/470008/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0444-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ruzotolimod-emea-003363-pip01-22_en.pdf"},
    {"id":"65735","name":"P/0441/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for luspatercept (Reblozyl), (EMEA-001521-PIP03-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T15:58:56Z","last_updated_date":"2024-11-20T15:58:56Z","reference_number":"EMA/401553/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0441-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-luspatercept-reblozyl-emea-001521-pip03-22_en.pdf"},
    {"id":"65731","name":"P/0438/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for pabinafusp alfa (EMEA-003033-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T15:52:46Z","last_updated_date":"2024-11-20T15:52:46Z","reference_number":"EMA/401556/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0438-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-pabinafusp-alfa-emea-003033-pip02-22_en.pdf"},
    {"id":"65729","name":"P/0437/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for uproleselan (EMEA-003307-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-20T15:44:17Z","last_updated_date":"2024-11-20T15:44:17Z","reference_number":"EMA/401558/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0437-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-uproleselan-emea-003307-pip01-22_en.pdf"},
    {"id":"65712","name":"P/0436/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for amlodipine / rosuvastatin (EMEA-003446-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T15:41:30Z","last_updated_date":"2024-11-19T15:41:30Z","reference_number":"EMA/401517/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0436-2023-ema-decision-27-october-2023-granting-product-specific-waiver-amlodipine-rosuvastatin-emea-003446-pip01-23_en.pdf"},
    {"id":"65711","name":"P/0435/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for xalnesiran, (EMEA-003362-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T15:34:18Z","last_updated_date":"2024-11-19T15:34:18Z","reference_number":"EMA/470007/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0435-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-xalnesiran-emea-003362-pip01-22_en.pdf"},
    {"id":"65710","name":"P/0433/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for zanidatamab (EMEA-003450-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T15:17:38Z","last_updated_date":"2024-11-19T15:17:38Z","reference_number":"EMA/424762/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0433-2023-ema-decision-27-october-2023-granting-product-specific-waiver-zanidatamab-emea-003450-pip01-23_en.pdf-0"},
    {"id":"65709","name":"P/0433/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for zanidatamab (EMEA-003450-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T15:04:54Z","last_updated_date":"2024-11-19T15:04:54Z","reference_number":"EMA/424762/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0433-2023-ema-decision-27-october-2023-granting-product-specific-waiver-zanidatamab-emea-003450-pip01-23_en.pdf"},
    {"id":"65708","name":"P/0432/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for self-complementary adeno-associated virus [AAV]......(DTX301) (EMEA-002830- PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T14:56:11Z","last_updated_date":"2024-11-19T14:56:11Z","reference_number":"EMA/470006/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0432-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-self-complementary-adeno-associated-virus-aavdtx301-emea-002830-pip01-20_en.pdf"},
    {"id":"65706","name":"P/0431/2023 : EMA decision of on the granting of a product specific waiver for modified recombinant version of the human myeloid-derived growth factor (EMEA-003449-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T12:01:35Z","last_updated_date":"2024-11-19T12:01:35Z","reference_number":"EMA/424754/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0431-2023-ema-decision-granting-product-specific-waiver-modified-recombinant-version-human-myeloid-derived-growth-factor-emea-003449-pip01-23_en.pdf"},
    {"id":"65705","name":"P/0430/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for inaxaplin, (EMEA-003368-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T11:51:23Z","last_updated_date":"2024-11-19T11:51:23Z","reference_number":"EMA/424746/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0430-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-inaxaplin-emea-003368-pip01-22_en.pdf"},
    {"id":"65704","name":"P/0429/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative, (EMEA-003461-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T10:51:34Z","last_updated_date":"2024-11-19T10:51:34Z","reference_number":"EMA/469858/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0429-2023-ema-decision-27-october-2023-granting-product-specific-waiver-humanised-igg1-monoclonal-antibody-against-trop2-conjugated-topoisomerase-i-inhibitor-belotecan-derivative-emea-003461-pip01_en.pdf"},
    {"id":"65703","name":"P/0428/2023 : EMA decision of 27 October on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of 6‐(piperidine‐1‐carbonyl)pyridin‐3‐ol (BI 764198), (EMEA-003347-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T10:40:12Z","last_updated_date":"2024-11-19T10:40:12Z","reference_number":"EMA/424721/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0428-2023-ema-decision-27-october-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-derivative-6-piperidine-1-carbonylpyridin-3-ol-bi-764198-emea-003347-pip01-22_en.pdf"},
    {"id":"65702","name":"P/0427/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for 2-[3-(dimethyl-1H-1,2,3-triazol-5-yl)-5-[(S)-oxan-4- yl(phenyl)methyl]-5H-pyrido[3,2-b]indol-7-yl]propan-2-ol, (EMEA-003456-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-19T10:25:45Z","last_updated_date":"2024-11-19T10:25:45Z","reference_number":"EMA/469615/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0427-2023-ema-decision-27-october-2023-granting-product-specific-waiver-2-3-dimethyl-1h-123-triazol-5-yl-5-s-oxan-4-ylphenylmethyl-5h-pyrido32-bindol-7-ylpropan-2-ol-emea-003456-pip01-23_en.pdf"},
    {"id":"65687","name":"P/0426/2023 : EMA decision of 27 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for haematopoietic stem cells and blood progenitors umbilical cord-derived...dihydrate (ECT001-CB), (EMEA-003025-PIP03-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-15T16:49:00Z","last_updated_date":"2024-11-15T16:49:00Z","reference_number":"EMA/424694/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0426-2023-ema-decision-27-october-2024-agreement-paediatric-investigation-plan-granting-deferral-haematopoietic-stem-cells-blood-progenitors-umbilical-cord-deriveddihydrate-ect001-cb-emea-003025_en.pdf"},
    {"id":"65686","name":"P/0425/2023 : EMA decision of 27 October 2023 on the granting of a product specific waiver for 2-((R)-3-(1-(1-((R)-1-(2,4-dichlorophenyl)ethyl)-3- (trifluoromethyl)-......benzenesulfonate,(EMEA-003455-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-15T16:41:22Z","last_updated_date":"2024-11-15T16:41:22Z","reference_number":"EMA/469371/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0425-2023-ema-decision-27-october-2023-granting-product-specific-waiver-2-r-3-1-1-r-1-24-dichlorophenylethyl-3-trifluoromethyl-benzenesulfonateemea-003455-pip01-23_en.pdf"},
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    {"id":"65684","name":"P/0421/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for ciraparantag (EMEA-003321-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-15T16:30:34Z","last_updated_date":"2024-11-15T16:30:34Z","reference_number":"EMA/429548/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0421-2023-ema-decision-27-october-2023-agreement-paediatric-investigation-plan-granting-deferral-ciraparantag-emea-003321-pip01-22_en.pdf"},
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    {"id":"65642","name":"P/0413/2023 : EMA decision of 25 October 2023 on the granting of a product specific waiver for ulviprubart (EMEA-003474-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-11-14T14:16:13Z","last_updated_date":"2024-11-14T14:16:13Z","reference_number":"EMA/469144/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0413-2023-ema-decision-25-october-2023-granting-product-specific-waiver-ulviprubart-emea-003474-pip01-23_en.pdf"},
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    {"id":"65212","name":"P/0391/2023: EMA decision of 13 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi), (EMEA-001776-PIP04-17-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-10-07T11:45:00Z","last_updated_date":"2024-10-07T11:45:00Z","reference_number":"EMA/412625/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0391-2023-ema-decision-13-september-2023-acceptance-modification-agreed-paediatric-investigation-plan-risankizumab-skyrizi-emea-001776-pip04-17-m01_en.pdf"},
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    {"id":"65168","name":"P/0394/2023 : EMA decision of 29 September 2023 on the granting of a product specific waiver for valemetostat tosilate (EMEA-003256-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-10-04T14:15:00Z","last_updated_date":"2024-10-04T14:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0394-2023-ema-decision-29-september-2023-granting-product-specific-waiver-valemetostat-tosilate-emea-003256-pip02-23_en.pdf"},
    {"id":"65166","name":"P/0343/2023: EMA decision of 8 September 2023 on the granting of a product specific waiver for ramipril / nebivolol (hydrochloride) (EMEA-003430- PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-10-04T14:00:00Z","last_updated_date":"2024-10-04T14:00:00Z","reference_number":"EMA/352008/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0343-2023-ema-decision-8-september-2023-granting-product-specific-waiver-ramipril-nebivolol-hydrochloride-emea-003430-pip01-23_en.pdf"},
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    {"id":"65162","name":"P/0366/2023 : EMA decision of 8 September 2023 on the granting of a product specific waiver for 3-[2-(Dimethylamino)ethyl]-1H-indol-4-yl dihydrogen phosphate (EMEA-002990-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-10-04T13:15:00Z","last_updated_date":"2024-10-04T13:15:00Z","reference_number":"EMA/384112/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0366-2023-ema-decision-8-september-2023-granting-product-specific-waiver-3-2-dimethylaminoethyl-1h-indol-4-yl-dihydrogen-phosphate-emea-002990-pip02-23_en.pdf"},
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    {"id":"65076","name":"P/0338/2023 : EMA decision of 17 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis), (EMEA-000183-PIP02-12-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-10-02T19:18:57Z","last_updated_date":"2024-10-02T19:18:57Z","reference_number":"EMA/351967/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0338-2023-ema-decision-17-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip02-12-m04_en.pdf"},
    {"id":"51683","name":"P/0288/2020: EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ombitasvir / paritaprevir / ritonavir (Viekirax), (EMEA-001440-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-06-30T14:09:00Z","last_updated_date":"2024-10-02T09:47:00Z","reference_number":"EMA/388709/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2020-ema-decision-12-august-2020-acceptance-modification-agreed-paediatric-investigation-plan-ombitasvir-paritaprevir-ritonavir-viekirax-emea-001440-pip01-13-m03_en.pdf"},
    {"id":"51646","name":"P/0289/2020 : EMA decision of 12 August 2020 on the acceptance of a modification of an agreed paediatric investigation plan for dasabuvir (sodium monohydrate) (Exviera) (EMEA-001439-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-06-28T13:31:00Z","last_updated_date":"2024-10-01T17:14:00Z","reference_number":"EMA/371374/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0289-2020-ema-decision-12-august-2020-acceptance-modification-agreed-paediatric-investigation-plan-dasabuvir-sodium-monohydrate-exviera-emea-001439-pip01-13-m03_en.pdf"},
    {"id":"64938","name":"P/0358/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for concizumab (EMEA-002326-PIP04-20-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T12:20:00Z","last_updated_date":"2024-09-19T12:20:00Z","reference_number":"EMA/347165/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0358-2023-ema-decision-8-september-2023-acceptance-modification-agreed-paediatric-investigation-plan-concizumab-emea-002326-pip04-20-m01_en.pdf"},
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    {"id":"64936","name":"P/0357/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for danicopan (EMEA-002310-PIP01-17-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T12:10:00Z","last_updated_date":"2024-09-19T12:10:00Z","reference_number":"EMA/347097/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0357-2023-ema-decision-8-september-2023-acceptance-modification-agreed-paediatric-investigation-plan-danicopan-emea-002310-pip01-17-m01_en.pdf"},
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    {"id":"64934","name":"P/0352/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for avacopan (Tavneos), (EMEA-002023-PIP01-16-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T12:00:00Z","last_updated_date":"2024-09-19T12:00:00Z","reference_number":"EMA/380478/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0352-2023-ema-decision-8-september-2023-acceptance-modification-agreed-paediatric-investigation-plan-avacopan-tavneos-emea-002023-pip01-16-m07_en.pdf"},
    {"id":"64933","name":"P/0379/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP01-16-M08)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T11:55:00Z","last_updated_date":"2024-09-19T11:55:00Z","reference_number":"EMA/351216/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0379-2023-ema-decision-8-september-2023-acceptance-modification-agreed-paediatric-investigation-plan-ravulizumab-ultomiris-emea-001943-pip01-16-m08_en.pdf"},
    {"id":"64932","name":"P/0378/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fremanezumab (Ajovy), (EMEA-001877-PIP01-15-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T11:48:00Z","last_updated_date":"2024-09-19T11:48:00Z","reference_number":"EMA/351214/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0378-2023-ema-decision-8-september-2023-acceptance-modification-agreed-paediatric-investigation-plan-fremanezumab-ajovy-emea-001877-pip01-15-m04_en.pdf"},
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    {"id":"64926","name":"EMA/384130/2023 : EMA decision of 8 September 2023 on the granting of a product specific waiver for abemaciclib (Verzenios), (EMEA-002342-PIP05-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T10:45:00Z","last_updated_date":"2024-09-19T10:45:00Z","reference_number":"EMA/384130/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-384130-2023-ema-decision-8-september-2023-granting-product-specific-waiver-abemaciclib-verzenios-emea-002342-pip05-23_en.pdf"},
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    {"id":"64923","name":"P/0381/2023 : EMA decision of 7 September 2023 on the granting of a product specific waiver for teprotumumab, (EMEA-001973-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T10:28:00Z","last_updated_date":"2024-09-19T10:28:00Z","reference_number":"EMA/389821/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0381-2023-ema-decision-7-september-2023-granting-product-specific-waiver-teprotumumab-emea-001973-pip02-23_en.pdf"},
    {"id":"64922","name":"P/0388/2023 : EMA decision of 7 September 2023 on the granting of a product specific waiver for ravulizumab (Ultomiris), (EMEA-001943-PIP06-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T09:53:00Z","last_updated_date":"2024-09-19T09:53:00Z","reference_number":"EMA/389665/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0388-2023-ema-decision-7-september-2023-granting-product-specific-waiver-ravulizumab-ultomiris-emea-001943-pip06-23_en.pdf"},
    {"id":"64920","name":"P/0383/2023 : EMA decision of 7 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for upadacitinib (Rinvoq), (EMEA-001741-PIP07-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T09:28:00Z","last_updated_date":"2024-09-19T09:28:00Z","reference_number":"EMA/388229/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0383-2023-ema-decision-7-september-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-upadacitinib-rinvoq-emea-001741-pip07-22_en.pdf"},
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    {"id":"64830","name":"P/0330/2023 : EMA decision of 8 August 2023 on the granting of a product specific waiver for domvanalimab, (EMEA-003429-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:50:24Z","last_updated_date":"2024-09-13T16:50:24Z","reference_number":"EMA/344572/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0330-2023-ema-decision-8-august-2023-granting-product-specific-waiver-domvanalimab-emea-003429-pip02-23_en.pdf"},
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    {"id":"64826","name":"P/0325/2023 : EMA decision of 8 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for delandistrogene moxeparvovec, (EMEA-002677-PIP01-19-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:45:15Z","last_updated_date":"2024-09-13T16:45:15Z","reference_number":"EMA/344540/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0325-2023-ema-decision-8-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-delandistrogene-moxeparvovec-emea-002677-pip01-19-m03_en.pdf"},
    {"id":"64825","name":"P/0337/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iclepertin (EMEA- 002653-PIP01-19-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:44:14Z","last_updated_date":"2024-09-13T16:44:14Z","reference_number":"EMA/356342/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0337-2023-ema-decision-11-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-iclepertin-emea-002653-pip01-19-m01_en.pdf"},
    {"id":"64824","name":"P/0335/2023 : EMA decision of 9 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for repotrectinib (EMEA-002635-PIP02-21-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:43:15Z","last_updated_date":"2024-09-13T16:43:15Z","reference_number":"EMA/347489/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0335-2023-ema-decision-9-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-repotrectinib-emea-002635-pip02-21-m02_en.pdf"},
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    {"id":"64822","name":"P/0312/2023 : EMA decision of 9 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP01-18-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:40:42Z","last_updated_date":"2024-09-13T16:40:42Z","reference_number":"EMA/335914/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0312-2023-ema-decision-9-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-abemaciclib-verzenios-emea-002342-pip01-18-m03_en.pdf"},
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    {"id":"64820","name":"P/0322/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for inclisiran (sodium) (Leqvio), (EMEA-002214-PIP01-17-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:36:16Z","last_updated_date":"2024-09-13T16:36:16Z","reference_number":"EMA/331021/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0322-2023-ema-decision-11-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-inclisiran-sodium-leqvio-emea-002214-pip01-17-m02_en.pdf"},
    {"id":"64819","name":"P/0302/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tremelimumab (Imjudo, Tremelimumab AstraZeneca), (EMEA-002029-PIP01-16-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:35:13Z","last_updated_date":"2024-09-13T16:35:13Z","reference_number":"EMA/336531/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2023-ema-decision-11-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-tremelimumab-imjudo-tremelimumab-astrazeneca-emea-002029-pip01-16-m04_en.pdf"},
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    {"id":"64816","name":"P/0320/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-09-13T16:31:40Z","last_updated_date":"2024-09-13T16:31:40Z","reference_number":"EMA/330868/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0320-2023-ema-decision-11-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-sufentanil-citrate-ketamine-hydrochloride-emea-001739-pip02-16-m02_en.pdf"},
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    {"id":"64263","name":"P/0120/2023 : EMA decision of 13 April 2023 on the granting of a product specific waiver for tadalafil / finasteride (EMEA-003323-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-22T12:16:45Z","last_updated_date":"2024-07-22T12:16:45Z","reference_number":"EMA/144889/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2023-ema-decision-13-april-2023-granting-product-specific-waiver-tadalafil-finasteride-emea-003323-pip01-22_en.pdf"},
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    {"id":"63993","name":"P/0227/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for gallium (68Ga) boclatixafortide (EMEA-003408-PIP01- 23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T14:08:32Z","last_updated_date":"2024-07-10T14:08:32Z","reference_number":"EMA/234911/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2023-ema-decision-14-june-2023-granting-product-specific-waiver-gallium-68ga-boclatixafortide-emea-003408-pip01-23_en.pdf"},
    {"id":"63992","name":"P/0224/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for candesartan (cilexetil) / indapamide (EMEA-003401-PIP01-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T14:05:01Z","last_updated_date":"2024-07-10T14:05:01Z","reference_number":"EMA/236264/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2023-ema-decision-14-june-2023-granting-product-specific-waiver-candesartan-cilexetil-indapamide-emea-003401-pip01-23_en.pdf"},
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    {"id":"63990","name":"P/0199/2023 : EMA decision of 13 June 2023 on the granting of a product specific waiver for amphotericin B (EMEA-003391-PIP01-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T13:57:15Z","last_updated_date":"2024-07-10T13:57:15Z","reference_number":"EMA/241151/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2023-ema-decision-13-june-2023-granting-product-specific-waiver-amphotericin-b-emea-003391-pip01-23_en.pdf"},
    {"id":"63989","name":"P/0207/2023 : EMA decision of 14 June 2023 on the refusal of a paediatric investigation plan and on the granting of a waiver for xylometazoline hydrochloride / sodium hyaluronate (EMEA-003387-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T13:41:00Z","last_updated_date":"2024-07-10T13:41:00Z","reference_number":"EMA/253298/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2023-ema-decision-14-june-2023-refusal-paediatric-investigation-plan-granting-waiver-xylometazoline-hydrochloride-sodium-hyaluronate-emea-003387-pip01-22_en.pdf"},
    {"id":"63988","name":"P/0220/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for levodopa / carbidopa monohydrate (EMEA-003384- PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T13:34:37Z","last_updated_date":"2024-07-10T13:34:37Z","reference_number":"EMA/236617/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2023-ema-decision-14-june-2023-granting-product-specific-waiver-levodopa-carbidopa-monohydrate-emea-003384-pip02-23_en.pdf"},
    {"id":"63987","name":"P/0218/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for inhibitor of receptor-interacting serine/threonineprotein kinase 1 (SAR443820) (EMEA-003383-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T13:33:35Z","last_updated_date":"2024-07-10T13:33:35Z","reference_number":"EMA/236613/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2023-ema-decision-14-june-2023-granting-product-specific-waiver-inhibitor-receptor-interacting-serine-threonineprotein-kinase-1-sar443820-emea-003383-pip02-23_en.pdf"},
    {"id":"63986","name":"P/0204/2023 : EMA decision of 5 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for zapomeran (EMEA-003349-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T13:30:33Z","last_updated_date":"2024-07-10T13:30:33Z","reference_number":"EMA/245863/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2023-ema-decision-5-june-2023-agreement-paediatric-investigation-plan-granting-deferral-zapomeran-emea-003349-pip01-22_en.pdf"},
    {"id":"63985","name":"P/0226/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for obeldesivir (EMEA-003306-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T12:17:14Z","last_updated_date":"2024-07-10T12:17:14Z","reference_number":"EMA/236621/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2023-ema-decision-14-june-2023-agreement-paediatric-investigation-plan-granting-deferral-obeldesivir-emea-003306-pip01-22_en.pdf"},
    {"id":"63981","name":"P/0222/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for crofelemer (EMEA-003296-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T12:14:21Z","last_updated_date":"2024-07-10T12:14:21Z","reference_number":"EMA/236242/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2023-ema-decision-14-june-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-crofelemer-emea-003296-pip01-22_en.pdf"},
    {"id":"63980","name":"P/0228/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for fosmanogepix, (EMEA-003280-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T10:56:16Z","last_updated_date":"2024-07-10T10:56:16Z","reference_number":"EMA/239204/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0228-2023-ema-decision-14-june-2023-agreement-paediatric-investigation-plan-granting-deferral-fosmanogepix-emea-003280-pip01-22_en.pdf"},
    {"id":"63979","name":"P/0225/2023 : EMA decision of 14 June 2023 on agreement of PIP and on granting of deferral and waiver for adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express achimeric antigen ...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T10:48:46Z","last_updated_date":"2024-07-10T10:48:46Z","reference_number":"EMA/235584/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2023-ema-decision-14-june-2023-agreement-pip-granting-deferral-waiver-adult-differentiated-autologous-t-cells-peripheral-blood-expanded-transduced-lentivirus-express-achimeric-antigen_en.pdf"},
    {"id":"63978","name":"P/0236/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for Derivative of (3S,3'S,3a'S,10a'S)-3'- phenyl-3',3a',10',10a'-tetrahydro-1'H-spiro[indoline-3,2'-pyrrolo[2',3':4,5]pyrrolo[1,2-b]indazol]-2- one, (EMEA-003260-PIP02","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T16:51:40Z","last_updated_date":"2024-07-10T16:51:40Z","reference_number":"EMA/238278/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2023-ema-decision-14-june-2023-granting-product-specific-waiver-derivative-3s3s3as10as-3-phenyl-33a1010a-tetrahydro-1h-spiroindoline-32-pyrrolo2345pyrrolo12-bindazol-2-one-emea-003260-pip02_en.pdf"},
    {"id":"63977","name":"P/0216/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for (S)-lactic acid (EMEA-003247-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T09:57:28Z","last_updated_date":"2024-07-10T09:57:28Z","reference_number":"EMA/234839/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2023-ema-decision-14-june-2023-granting-product-specific-waiver-s-lactic-acid-emea-003247-pip02-23_en.pdf"},
    {"id":"63976","name":"P/0219/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for asunercept (EMEA-003201-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T09:49:28Z","last_updated_date":"2024-07-10T09:49:28Z","reference_number":"EMA/235062/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2023-ema-decision-14-june-2023-agreement-paediatric-investigation-plan-granting-deferral-asunercept-emea-003201-pip01-22_en.pdf"},
    {"id":"63975","name":"P/0239/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for belzutifan, (EMEA-002619-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T09:44:08Z","last_updated_date":"2024-07-10T09:44:08Z","reference_number":"EMA/238267/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2023-ema-decision-14-june-2023-granting-product-specific-waiver-belzutifan-emea-002619-pip02-23_en.pdf"},
    {"id":"63946","name":"P/0208/2023 : EMA decision of 14 June 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efgartigimod alfa (EMEA-002597-PIP08-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-10T16:08:28Z","last_updated_date":"2024-07-10T16:08:28Z","reference_number":"EMA/253550/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2023-ema-decision-14-june-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-efgartigimod-alfa-emea-002597-pip08-22_en.pdf"},
    {"id":"63940","name":"P/0205/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for deutetrabenazine (EMEA-002052-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T16:45:21Z","last_updated_date":"2024-07-05T16:45:21Z","reference_number":"EMA/253093/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2023-ema-decision-14-june-2023-granting-product-specific-waiver-deutetrabenazine-emea-002052-pip02-23_en.pdf"},
    {"id":"63939","name":"P/0194/2023 : EMA decision of 6 June 2023 on the granting of a product specific waiver for chlorhexidine (digluconate) / isopropyl alcohol (EMEA-001338-PIP02-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T16:37:58Z","last_updated_date":"2024-07-05T16:37:58Z","reference_number":"EMA/254485/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2023-ema-decision-6-june-2023-granting-product-specific-waiver-chlorhexidine-digluconate-isopropyl-alcohol-emea-001338-pip02-23_en.pdf"},
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    {"id":"63926","name":"P/0214/2023: EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cenobamate (Ontozry), (EMEA-002563-PIP02-19-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T15:27:38Z","last_updated_date":"2024-07-05T15:27:38Z","reference_number":"EMA/256562/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2023-ema-decision-14-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-cenobamate-ontozry-emea-002563-pip02-19-m02_en.pdf"},
    {"id":"63932","name":"P/0238/2023 : EMA decision of 14 June 2023on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T15:37:44Z","last_updated_date":"2024-07-05T15:37:44Z","reference_number":"EMA/236249/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0238-2023-ema-decision-14-june-2023on-acceptance-modification-agreed-paediatric-investigation-plan-regdanvimab-regkirona-emea-002961-pip01-21-m02_en.pdf"},
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    {"id":"63929","name":"P/0213/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed PIP for deferoxamine (mesylate) / histidine / tryptophan / aspartic acid / n-acetyl-histidine ... (EMEA- 002735-PIP03-20-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T15:33:22Z","last_updated_date":"2024-07-05T15:33:22Z","reference_number":"EMA/236603/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2023-ema-decision-14-june-2023-acceptance-modification-agreed-pip-deferoxamine-mesylate-histidine-tryptophan-aspartic-acid-n-acetyl-histidine-emea-002735-pip03-20-m02_en.pdf"},
    {"id":"63927","name":"P/0210/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed PIP for deferoxamine / histidine / tryptophan / aspartic acid / n-acetyl-histidine / glycine / alphaketoglutaric acid / ... (EMEA- 002735-PIP01-19-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T15:28:36Z","last_updated_date":"2024-07-05T15:28:36Z","reference_number":"EMA/236601/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2023-ema-decision-14-june-2023-acceptance-modification-agreed-pip-deferoxamine-histidine-tryptophan-aspartic-acid-n-acetyl-histidine-glycine-alphaketoglutaric-acid-emea-002735-pip01-19-m01_en.pdf"},
    {"id":"63925","name":"P/0217/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinylestradiol (EMEA-002229-PIP02-21-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T15:24:09Z","last_updated_date":"2024-07-05T15:24:09Z","reference_number":"EMA/238158/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2023-ema-decision-14-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-dienogest-ethinylestradiol-emea-002229-pip02-21-m01_en.pdf"},
    {"id":"63922","name":"P/0242/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:49:59Z","last_updated_date":"2024-07-05T14:49:59Z","reference_number":"EMA/250921/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2023-ema-decision-14-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-bictegravir-emtricitabine-tenofovir-alafenamide-biktarvy-emea-001766-pip01-15-m05_en.pdf"},
    {"id":"63920","name":"P/0203/2023 : EMA decision of 13 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for efinaconazole (EMEA- 001627-PIP01-14-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:46:51Z","last_updated_date":"2024-07-05T14:46:51Z","reference_number":"EMA/241957/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2023-ema-decision-13-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-efinaconazole-emea-001627-pip01-14-m03_en.pdf"},
    {"id":"63919","name":"P/0243/2023 : EMA decision of 16 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for birch bark extract (Filsuvez), (EMEA-001299-PIP03-17-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:44:35Z","last_updated_date":"2024-07-05T14:44:35Z","reference_number":"EMA/273941/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2023-ema-decision-16-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-birch-bark-extract-filsuvez-emea-001299-pip03-17-m02_en.pdf"},
    {"id":"63916","name":"P/0202/2023 : EMA decision of 13 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP01-11-M08)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:37:32Z","last_updated_date":"2024-07-05T14:37:32Z","reference_number":"EMA/241941/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0202-2023-ema-decision-13-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-olumiant-emea-001220-pip01-11-m08_en.pdf"},
    {"id":"63915","name":"P/0221/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for landiolol (hydrochloride) (Rapibloc, Landiobloc, Raploc, Runrapiq), (EMEA-001150-PIP02-13-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T14:35:34Z","last_updated_date":"2024-07-05T14:35:34Z","reference_number":"EMA/236236/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2023-ema-decision-14-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-landiolol-hydrochloride-rapibloc-landiobloc-raploc-runrapiq-emea-001150-pip02-13-m05_en.pdf"},
    {"id":"63893","name":"P/0212/2023 : EMA decision of 14 June 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brodalumab (Kyntheum), (EMEA-001089-PIP02-13-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T11:38:39Z","last_updated_date":"2024-07-05T11:38:39Z","reference_number":"EMA/236234/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2023-ema-decision-14-june-2023-acceptance-modification-agreed-paediatric-investigation-plan-brodalumab-kyntheum-emea-001089-pip02-13-m04_en.pdf"},
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    {"id":"63879","name":"P/0166/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for peptide derivative of glucagon-like-peptide 1 and glucagon with fatty acid side chain (EMEA-002942-PIP02-20-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-04T14:56:00Z","last_updated_date":"2024-07-04T14:56:00Z","reference_number":"EMA/160447/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-peptide-derivative-glucagon-peptide-1-glucagon-fatty-acid-side-chain-emea-002942-pip02-20-m01_en.pdf"},
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    {"id":"63876","name":"P/0164/2023 : EMA decision of 15 May 2023 on  the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP01-19-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-04T14:42:00Z","last_updated_date":"2024-07-04T14:42:00Z","reference_number":"EMA/160444/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-iptacopan-emea-002705-pip01-19-m01_en.pdf"},
    {"id":"63875","name":"P/0159/2023 : EMA decision of 12 May 2023 on on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP05-21-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-07-04T14:36:00Z","last_updated_date":"2024-07-04T14:36:00Z","reference_number":"EMA/170275/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2023-ema-decision-12-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-efgartigimod-alfa-vyvgart-emea-002597-pip05-21-m01_en.pdf"},
    {"id":"63674","name":"P/0180/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for recombinant humanized monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1κ) ... (EMEA-003376-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T16:21:32Z","last_updated_date":"2024-06-18T16:21:32Z","reference_number":"EMA/176012/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2023-ema-decision-15-may-2023-granting-product-specific-waiver-recombinant-humanized-monoclonal-antibody-immunoglobulin-gamma-1-kappa-light-chains-igg1k-emea-003376-pip01-22_en.pdf"},
    {"id":"63672","name":"P/0188/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene (LY3884963) (EMEA-003374-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T14:52:12Z","last_updated_date":"2024-06-18T14:52:12Z","reference_number":"EMA/198966/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2023-ema-decision-15-may-2023-granting-product-specific-waiver-adeno-associated-viral-vector-serotype-9-expressing-codon-optimized-human-grn-gene-ly3884963-emea-003374-pip01-22_en.pdf"},
    {"id":"63671","name":"P/0158/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-003373-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T14:36:10Z","last_updated_date":"2024-06-18T14:36:10Z","reference_number":"EMA/170258/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2023-ema-decision-12-may-2023-granting-product-specific-waiver-atorvastatin-ezetimibe-emea-003373-pip01-22_en.pdf"},
    {"id":"63668","name":"P/0157/2023: EMA decision of 12 May 2023 on the granting of a product-specific waiver for ramipril / indapamide (EMEA-003372-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T14:13:36Z","last_updated_date":"2024-06-18T14:13:36Z","reference_number":"EMA/170257/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2023-ema-decision-12-may-2023-granting-product-specific-waiver-ramipril-indapamide-emea-003372-pip01-22_en.pdf"},
    {"id":"19697","name":"P/0313/2014: EMA decision of 26 November 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pandemic live attenuated influenza virus (H5N1) (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/667770/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0313-2014-ema-decision-26-november-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pandemic-live-attenuated-influenza-virus-h5n1-eme_en.pdf"},
    {"id":"62127","name":"P/0021/2023: EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the  granting of a waiver for asundexian (EMEA-003144-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-02-13T16:59:03Z","last_updated_date":"2024-02-13T16:59:03Z","reference_number":"EMA/20377/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2023-ema-decision-31-january-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-asundexian-emea-003144-pip01-21_en.pdf"},
    {"id":"63287","name":"P/0001/2024 : EMA decision of 3 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ivosidenib (Tibsovo), (EMEA-002247-PIP03-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-05-21T15:44:00Z","last_updated_date":"2024-05-21T15:44:00Z","reference_number":"EMA/931/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2024-ema-decision-3-january-2024-acceptance-modification-agreed-paediatric-investigation-plan-ivosidenib-tibsovo-emea-002247-pip03-17-m01_en.pdf"},
    {"id":"2486","name":"P/0317/2013: EMA decision of 19 December 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for estetrol / levonorgestrel (EMEA-001513-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T00:00:00Z","last_updated_date":"2014-02-05T00:00:00Z","reference_number":"EMA/725501/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0317-2013-ema-decision-19-december-2013-agreement-paediatric-investigation-plan-granting-waiver-estetrol-levonorgestrel-emea-001513-pip01-13_en.pdf"},
    {"id":"25845","name":"P/0318/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for alpha-1 antitrypsin (EMEA-001525-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/693820/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0318-2013-ema-decision-19-december-2013-granting-product-specific-waiver-alpha-1-antitrypsin-emea-001525-pip01-13_en.pdf"},
    {"id":"26221","name":"P/220/2009: European Medicines Agency decision of 3 November 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for latanoprost (Xalatan and associated names) (EMEA-000011-PIP01-07-M03) i...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:00:00Z","last_updated_date":"2009-12-23T00:00:00Z","reference_number":"EMEA/688850/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-220-2009-european-medicines-agency-decision-3-november-2009-acceptance-modification-agreed-paediatric-investigation-plan-latanoprost-xalatan-associated-names-emea-000011-pip01-07-m03-i_en.pdf"},
    {"id":"29977","name":"P/61/2010: European Medicines Agency decision on the acceptance of a modification of an agreed paediatric investigation plan for nomegestrol acetate / 17 beta - estradiol (EMEA-000250-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/216040/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-61-2010-european-medicines-agency-decision-acceptance-modification-agreed-paediatric-investigation-plan-nomegestrol-acetate-17-beta-estradiol-emea-000250-pip01-08-m02_en.pdf"},
    {"id":"35254","name":"P/0286/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (NAXIGLO and associated names), (EMEA-000454-PIP01-08-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T11:00:00Z","last_updated_date":"2017-01-23T11:00:00Z","reference_number":"EMA/639654/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0286-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-naxiglo-associated-names-emea-000454-pip01-08-m07_en.pdf"},
    {"id":"37240","name":"P/115/2009: European Medicines Agency decision of 15 June 2009 on the granting of a product specific waiver for Pravastatin sodium / Fenofibrate (EMEA-000501-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351862/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-115-2009-european-medicines-agency-decision-15-june-2009-granting-product-specific-waiver-pravastatin-sodium-fenofibrate-emea-000501-pip01-08-accordance-regulation-ec-no-1901-2006-t_en.pdf"},
    {"id":"39658","name":"P/0293/2015: EMA decision of 27 November 2015 on the granting of a product specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/689489/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0293-2015-ema-decision-27-november-2015-granting-product-specific-waiver-olmesartan-medoxomil-amlodipine-besilate-emea-001852-pip01-15_en.pdf"},
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    {"id":"63537","name":"P/0116/2023 : EMA decision of 13 April 2023 on the granting of a product specific waiver for meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) (EMEA-000032-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T14:54:32Z","last_updated_date":"2024-06-07T14:54:32Z","reference_number":"EMA/103738/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0116-2023-ema-decision-13-april-2023-granting-product-specific-waiver-meningococcal-group-oligosaccharide-conjugated-corynebacterium-diphteriae-crm197-protein-mena-crm-emea-000032-pip02-22_en.pdf"},
    {"id":"63414","name":"P/0169/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF.....(EMEA-003370-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T09:00:00Z","last_updated_date":"2024-06-07T09:00:00Z","reference_number":"EMA/160482/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2023-ema-decision-15-may-2023-granting-product-specific-waiver-palmitoyl-kss-mhgdtptlheymldlqpett-hpv-16-e7-1-20-palmitoyl-kss-ymldlqpett-hpv-16-e7-11-20-palmitoyl-kss-gqaepdrahynivtfemea_en.pdf"},
    {"id":"63409","name":"P/0181/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for 1-((S)-4-((R)-7-(6-amino-4-methyl-3- (trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro-2-(((S)-1-methylpyrrolidin-2-yl).....(EMEA-003364-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T09:00:00Z","last_updated_date":"2024-06-07T09:00:00Z","reference_number":"EMA/176269/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2023-ema-decision-15-may-2023-granting-product-specific-waiver-1-s-4-r-7-6-amino-4-methyl-3-trifluoromethylpyridin-2-yl-6-chloro-8-fluoro-2-s-1-methylpyrrolidin-2-ylemea-003364-pip02-22_en.pdf"},
    {"id":"63407","name":"P/0161/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for diclofenac / thiocolchicoside (EMEA-003339-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T09:00:00Z","last_updated_date":"2024-06-07T09:00:00Z","reference_number":"EMA/170255/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2023-ema-decision-12-may-2023-granting-product-specific-waiver-diclofenac-thiocolchicoside-emea-003339-pip02-23_en.pdf"},
    {"id":"63395","name":"P/0198/2023 : EMA decision of 22 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised VHH-type bispecific antibody against complement.....(EMEA-003302-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T09:00:00Z","last_updated_date":"2024-06-07T09:00:00Z","reference_number":"EMA/220354/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2023-ema-decision-22-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-humanised-vhh-type-bispecific-antibody-against-complementemea-003302-pip01-22_en.pdf"},
    {"id":"63393","name":"P/0168/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for albaconazole (EMEA-003279-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T13:32:00Z","last_updated_date":"2024-06-07T13:32:00Z","reference_number":"EMA/160497/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2023-ema-decision-15-may-2023-agreement-paediatric-investigation-plan-granting-waiver-albaconazole-emea-003279-pip01-22_en.pdf"},
    {"id":"63389","name":"P/0184/2023 : EMA decision of 19 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aticaprant (EMEA-003251-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T09:00:00Z","last_updated_date":"2024-06-07T09:00:00Z","reference_number":"EMA/171173/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2023-ema-decision-19-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aticaprant-emea-003251-pip01-22_en.pdf"},
    {"id":"63388","name":"P/0178/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for itolizumab (EMEA-003208-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T09:00:00Z","last_updated_date":"2024-06-07T09:00:00Z","reference_number":"EMA/171157/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2023-ema-decision-15-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-itolizumab-emea-003208-pip02-22_en.pdf"},
    {"id":"63535","name":"P/0190/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP04-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T11:25:00Z","last_updated_date":"2024-06-07T11:25:00Z","reference_number":"EMA/201814/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-guselkumab-tremfya-emea-001523-pip04-19-m02_en.pdf"},
    {"id":"63534","name":"P/0189/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cholera vaccine, live attenuated, oral (strain CVD 103-HgR) (Vaxchora), (EMEA-001490-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T11:21:00Z","last_updated_date":"2024-06-07T11:21:00Z","reference_number":"EMA/201813/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-cholera-vaccine-live-attenuated-oral-strain-cvd-103-hgr-vaxchora-emea-001490-pip01-13-m04_en.pdf"},
    {"id":"63533","name":"P/0192/2023 : EMA decision of 26 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for vatiquinone (EMEA-001238-PIP03-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T11:14:00Z","last_updated_date":"2024-06-07T11:14:00Z","reference_number":"EMA/186780/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2023-ema-decision-26-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-vatiquinone-emea-001238-pip03-21-m01_en.pdf"},
    {"id":"63532","name":"P/0177/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-07T11:10:00Z","last_updated_date":"2024-06-07T11:10:00Z","reference_number":"EMA/171114/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m10_en.pdf"},
    {"id":"63522","name":"P/0173/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra), (EMEA-001214-PIP09-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-06T15:54:00Z","last_updated_date":"2024-06-06T15:54:00Z","reference_number":"EMA/171103/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-fasenra-emea-001214-pip09-21-m01_en.pdf"},
    {"id":"63520","name":"P/0172/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for migalastat (hydrochloride) (Galafold), (EMEA-001194-PIP01-11-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-06T15:49:00Z","last_updated_date":"2024-06-06T15:49:00Z","reference_number":"EMA/171090/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-migalastat-hydrochloride-galafold-emea-001194-pip01-11-m06_en.pdf"},
    {"id":"63519","name":"P/0171/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-06T15:44:00Z","last_updated_date":"2024-06-06T15:44:00Z","reference_number":"EMA/171049/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-romosozumab-evenity-emea-001075-pip04-15-m06_en.pdf"},
    {"id":"63517","name":"P/0170/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for elosulfase alfa (Vimizim), (EMEA-000973-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-06T15:29:00Z","last_updated_date":"2024-06-06T15:29:00Z","reference_number":"EMA/170999/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0170-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-elosulfase-alfa-vimizim-emea-000973-pip01-10-m04_en.pdf"},
    {"id":"63516","name":"P/0183/2023 : EMA decision of 19 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for maribavir (Livtencity), (EMEA-000353-PIP02-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-06T15:18:00Z","last_updated_date":"2024-06-06T15:18:00Z","reference_number":"EMA/170667/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0183-2023-ema-decision-19-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-maribavir-livtencity-emea-000353-pip02-16-m03_en.pdf"},
    {"id":"63515","name":"P/0196/2023 : EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-06T15:13:00Z","last_updated_date":"2024-06-06T15:13:00Z","reference_number":"EMA/PDCO/210857/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip01-07-m13_en.pdf"},
    {"id":"63471","name":"P/0105/2023 : EMA decision of 13 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for obeticholic acid (Ocaliva), (EMEA-001304-PIP02-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-03T19:26:21Z","last_updated_date":"2024-06-03T19:26:21Z","reference_number":"EMA/103714/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2023-ema-decision-13-april-2023-acceptance-modification-agreed-paediatric-investigation-plan-obeticholic-acid-ocaliva-emea-001304-pip02-13-m06_en.pdf"},
    {"id":"63470","name":"P/0104/2023 : EMA decision of 13 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Tenkasi), (EMEA-001270-PIP01-12-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-03T16:00:36Z","last_updated_date":"2024-06-03T16:00:36Z","reference_number":"P/0104/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0104-2023-ema-decision-13-april-2023-acceptance-modification-agreed-paediatric-investigation-plan-oritavancin-diphosphate-tenkasi-emea-001270-pip01-12-m06_en.pdf"},
    {"id":"63469","name":"P/0135/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for osilodrostat (Isturisa), (EMEA-000315-PIP02-15-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-03T15:48:20Z","last_updated_date":"2024-06-03T15:48:20Z","reference_number":"EMA/134574/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2023-ema-decision-14-april-2023-acceptance-modification-agreed-paediatric-investigation-plan-osilodrostat-isturisa-emea-000315-pip02-15-m03_en.pdf"},
    {"id":"63468","name":"P/0124/2023 : EMA decision of 14 April 2023 on the refusal of a modification of an agreed paediatric investigation plan for eculizumab (Soliris), (EMEA-000876-PIP03-14-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-03T15:34:27Z","last_updated_date":"2024-06-03T15:34:27Z","reference_number":"EMA/134196/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2023-ema-decision-14-april-2023-refusal-modification-agreed-paediatric-investigation-plan-eculizumab-soliris-emea-000876-pip03-14-m06_en.pdf"},
    {"id":"63467","name":"P/0154/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2- yl)oxy)phenyl)...(EMEA-003371-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-06-03T15:26:00Z","last_updated_date":"2024-06-03T15:26:00Z","reference_number":"EMA/170256/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2023-ema-decision-12-may-2023-granting-product-specific-waiver-n-4-4-amino-5-3-fluoro-4-4-methylpyrimidin-2-yloxyphenylemea-003371-pip01-22_en.pdf"},
    {"id":"63458","name":"P/0123/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Prolia, Xgeva), (EMEA-000145-PIP02-12-M05) ","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-06-03T14:47:33Z","last_updated_date":"2024-06-03T14:47:33Z","reference_number":"EMA/134107/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2023-ema-decision-14-april-2023-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-prolia-xgeva-emea-000145-pip02-12-m05_en.pdf"},
    {"id":"63394","name":"P/0153/2023 : EMA decision of 12 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for favezelimab/pembrolizumab (EMEA-003104-PIP02-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T13:37:00Z","last_updated_date":"2024-05-30T13:37:00Z","reference_number":"EMA/170247/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2023-ema-decision-12-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-favezelimab-pembrolizumab-emea-003104-pip02-22_en.pdf"},
    {"id":"63392","name":"P/0174/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vibostolimab/pembrolizumab, (EMEA-003063-PIP02-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T13:32:00Z","last_updated_date":"2024-05-30T13:32:00Z","reference_number":"EMA/177600/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2023-ema-decision-15-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vibostolimab-pembrolizumab-emea-003063-pip02-22_en.pdf"},
    {"id":"63391","name":"P/0182/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2’-O-(2-methoxyethyl) modified... (EMEA-003024-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T13:20:00Z","last_updated_date":"2024-05-30T13:20:00Z","reference_number":"EMA/176376/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2023-ema-decision-15-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2-o-2-methoxyethyl-modified-emea-003024-pip01-21_en.pdf"},
    {"id":"63387","name":"P/0163/2023: EMA decision of of 15 May 2023 on the granting of a product specific waiver for nipocalimab (EMEA-002559-PIP07-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T12:57:00Z","last_updated_date":"2024-05-30T12:57:00Z","reference_number":"EMA/160467/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2023-ema-decision-15-may-2023-granting-product-specific-waiver-nipocalimab-emea-002559-pip07-22_en.pdf"},
    {"id":"63386","name":"P/0187/2023: EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atrasentan (EMEA-001666-PIP02-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T12:47:00Z","last_updated_date":"2024-05-30T12:47:00Z","reference_number":"EMA/184300/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2023-ema-decision-15-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-atrasentan-emea-001666-pip02-21_en.pdf"},
    {"id":"63379","name":"P/0191/2023: EMA decision of 26 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ocrelizumab (Ocrevus), (EMEA-000310-PIP05-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T10:43:00Z","last_updated_date":"2024-05-30T10:43:00Z","reference_number":"EMA/184305/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2023-ema-decision-26-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ocrelizumab-ocrevus-emea-000310-pip05-22_en.pdf"},
    {"id":"63355","name":"P/0156/2023: EMA decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for valoctocogene roxaparvovec (Roctavian), (EMEA-002427-PIP01-18-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T16:23:00Z","last_updated_date":"2024-05-28T16:23:00Z","reference_number":"EMA/170273/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2023-ema-decision-12-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-valoctocogene-roxaparvovec-roctavian-emea-002427-pip01-18-m02_en.pdf"},
    {"id":"63354","name":"P/0160/2023: Decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine / meloxicam (Zynrelef), (EMEA-002246-PIP01-17-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T16:14:00Z","last_updated_date":"2024-05-28T16:14:00Z","reference_number":"EMA/170272/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2023-decision-12-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-bupivacaine-meloxicam-zynrelef-emea-002246-pip01-17-m03_en.pdf"},
    {"id":"63353","name":"P/0176/2023: EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dasiglucagon (EMEA- 002233-PIP01-17-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T15:58:00Z","last_updated_date":"2024-05-28T15:58:00Z","reference_number":"EMA/177613/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-dasiglucagon-emea-002233-pip01-17-m02_en.pdf"},
    {"id":"63351","name":"P/0175/2023: EMA decision of 15 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for lasmiditan (Rayvow), (EMEA-002166-PIP01-17-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T15:47:00Z","last_updated_date":"2024-05-28T15:47:00Z","reference_number":"EMA/177631/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2023-ema-decision-15-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-lasmiditan-rayvow-emea-002166-pip01-17-m07_en.pdf"},
    {"id":"63350","name":"P/0193/2023: EMA decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / rilpivirine / tenofovir alafenamide (Odefsey), (EMEA-001679-PIP01-14-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T15:33:00Z","last_updated_date":"2024-05-28T15:33:00Z","reference_number":"EMA/209067/2023 Corri","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2023-ema-decision-12-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-emtricitabine-rilpivirine-tenofovir-alafenamide-odefsey-emea-001679-pip01-14-m03_en.pdf"},
    {"id":"63344","name":"P/0162/2023 : EMA decision of 12 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride), (Reagila), (EMEA-001652-PIP01-14-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T15:12:00Z","last_updated_date":"2024-05-28T15:12:00Z","reference_number":"EMA/170271/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2023-ema-decision-12-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-cariprazine-hydrochloride-reagila-emea-001652-pip01-14-m05_en.pdf"},
    {"id":"63342","name":"P/0179/2023: EMA decision of 17 May 2023 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (Kerendia), (EMEA-001623-PIP01-14-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-05-28T14:51:00Z","last_updated_date":"2024-05-28T14:51:00Z","reference_number":"EMA/175863/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2023-ema-decision-17-may-2023-acceptance-modification-agreed-paediatric-investigation-plan-finerenone-kerendia-emea-001623-pip01-14-m06_en.pdf"},
    {"id":"63291","name":"P/0480/2023 : EMA decision of 1 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for cobolimab (EMEA-003273-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-05-21T16:48:00Z","last_updated_date":"2024-05-21T16:48:00Z","reference_number":"EMA/498512/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0480-2023-ema-decision-1-december-2023-agreement-paediatric-investigation-plan-granting-deferral-cobolimab-emea-003273-pip02-22_en.pdf"},
    {"id":"63290","name":"P/0422/2023 : EMA decision of 27 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fazirsiran (EMEA-003355-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-05-21T16:38:00Z","last_updated_date":"2024-05-21T16:38:00Z","reference_number":"EMA/429563/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0422-2023-ema-decision-27-october-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fazirsiran-emea-003355-pip01-22_en.pdf"},
    {"id":"63289","name":"P/0411/2023 : EMA decision of 25 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for deucrictibant (EMEA-003090-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-05-21T16:23:00Z","last_updated_date":"2024-05-21T16:23:00Z","reference_number":"EMA/469125/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0411-2023-ema-decision-25-october-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-deucrictibant-emea-003090-pip02-22_en.pdf"},
    {"id":"58183","name":"P/0559/2021 : EMA decision of 27 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for COVID-19 vaccine (ChAdOx1-S [recombinant]) (Vaxzevria), (EMEA-002862-PIP01-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T11:57:00Z","last_updated_date":"2024-05-07T11:00:00Z","reference_number":"EMA/707190/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0559-2021-ema-decision-27-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-covid-19-vaccine-chadox1-s-recombinant-vaxzevria-emea-002862-pip01-20-m02_en.pdf"},
    {"id":"62923","name":"P/0336/2023 : EMA decision of 7 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for bosutinib (Bosulif), (EMEA-000727-PIP01-09-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-11T16:20:08Z","last_updated_date":"2024-04-11T16:20:08Z","reference_number":"EMA/351976/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0336-2023-ema-decision-7-august-2023-acceptance-modification-agreed-paediatric-investigation-plan-bosutinib-bosulif-emea-000727-pip01-09-m07_en.pdf"},
    {"id":"62865","name":"P/0091/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for quizartinib (EMEA- 001821-PIP01-15-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-08T10:21:47Z","last_updated_date":"2024-04-08T10:21:47Z","reference_number":"EMA/73601/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-quizartinib-emea-001821-pip01-15-m06_en.pdf"},
    {"id":"62864","name":"P/0068/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for budesonide / glycopyrronium bromide / formoterol (fumarate), (Trixeo Aerosphere), (EMEA-002063-PIP01-16-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-08T09:55:03Z","last_updated_date":"2024-04-08T09:55:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-budesonide-glycopyrronium-bromide-formoterol-fumarate-trixeo-aerosphere-emea-002063-pip01-16-m02_en.pdf"},
    {"id":"62863","name":"P/0086/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for risdiplam (Evrysdi), (EMEA-002070-PIP01-16-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-08T09:51:25Z","last_updated_date":"2024-04-08T09:51:25Z","reference_number":"EMA/37955/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0086-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-risdiplam-evrysdi-emea-002070-pip01-16-m07_en.pdf"},
    {"id":"62862","name":"P/0070/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for lumasiran (Oxlumo), (EMEA-002079-PIP01-16-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-08T09:38:24Z","last_updated_date":"2024-04-08T09:38:24Z","reference_number":"EMA/84334/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-lumasiran-oxlumo-emea-002079-pip01-16-m03_en.pdf"},
    {"id":"62861","name":"P/0100/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for glucagon analogue linked to a human immunoglobulin Fc fragment (HM15136) (EMEA-003170-PIP01-21-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-08T09:34:06Z","last_updated_date":"2024-04-08T09:34:06Z","reference_number":"EMA/108322/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0100-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-glucagon-analogue-linked-human-immunoglobulin-fc-fragment-hm15136-emea-003170-pip01-21-m01_en.pdf"},
    {"id":"62860","name":"P/0093/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact), (EMEA-000332-PIP02-17-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:54:10Z","last_updated_date":"2024-04-05T17:54:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-briviact-emea-000332-pip02-17-m04_en.pdf"},
    {"id":"62859","name":"P/0080/2023 : EMA decision of 13 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for methoxyflurane (Penthrox and associated names) (EMEA-000334-PIP01-08-M11)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:34:28Z","last_updated_date":"2024-04-05T17:34:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2023-ema-decision-13-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-methoxyflurane-penthrox-associated-names-emea-000334-pip01-08-m11_en.pdf"},
    {"id":"62858","name":"P/0102/2023 : EMA decision of 24 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M14)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:30:25Z","last_updated_date":"2024-04-05T17:30:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2023-ema-decision-24-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-xeljanz-emea-000576-pip01-09-m14_en.pdf"},
    {"id":"62857","name":"P/0088/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for selexipag (Uptravi), (EMEA-000997-PIP01-10-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:26:49Z","last_updated_date":"2024-04-05T17:26:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0088-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-selexipag-uptravi-emea-000997-pip01-10-m06_en.pdf"},
    {"id":"62856","name":"P/0063/2023 : EMA decision of 3 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP01-11-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:20:23Z","last_updated_date":"2024-04-05T17:20:23Z","reference_number":"EMA/84139/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2023-ema-decision-3-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-olumiant-emea-001220-pip01-11-m07_en.pdf"},
    {"id":"62855","name":"P/0077/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pozelimab (EMEA-003238-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:15:13Z","last_updated_date":"2024-04-05T17:15:13Z","reference_number":"EMA/74611/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pozelimab-emea-003238-pip01-22_en.pdf"},
    {"id":"62854","name":"P/0074/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (S)-2-hydroxy-6-((4-(2-(2-hydroxyethyl) nicotinoyl) morpholin-3-yl) methoxy) benzaldehyde","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:10:57Z","last_updated_date":"2024-04-05T17:10:57Z","reference_number":"EMA/85287/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-s-2-hydroxy-6-4-2-2-hydroxyethyl-nicotinoyl-morpholin-3-yl-methoxy-benzaldehyde_en.pdf"},
    {"id":"62853","name":"P/0084/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lutetium (177Lu) edotreotide (EMEA-003245-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T17:05:44Z","last_updated_date":"2024-04-05T17:05:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lutetium-177lu-edotreotide-emea-003245-pip01-22_en.pdf"},
    {"id":"62852","name":"P/0066/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for varicella virus OKA strain (live, attenuated) (EMEA-003317-PIP02-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T16:59:10Z","last_updated_date":"2024-04-05T16:59:10Z","reference_number":"EMA/84288/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2023-ema-decision-10-march-2023-granting-product-specific-waiver-varicella-virus-oka-strain-live-attenuated-emea-003317-pip02-22_en.pdf"},
    {"id":"62851","name":"P/0073/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ibutamoren mesylate (EMEA-003032-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T16:43:16Z","last_updated_date":"2024-04-05T16:43:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-ibutamoren-mesylate-emea-003032-pip01-21-m01_en.pdf"},
    {"id":"62841","name":"P/0092/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zilebesiran (sodium) (EMEA-003218-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T14:17:41Z","last_updated_date":"2024-04-05T14:17:41Z","reference_number":"EMA/74715/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-zilebesiran-sodium-emea-003218-pip01-22_en.pdf"},
    {"id":"62843","name":"P/0065/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cemdisiran (EMEA-003237-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T14:28:31Z","last_updated_date":"2024-04-05T14:28:31Z","reference_number":"EMA/84291/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0065-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cemdisiran-emea-003237-pip01-22_en.pdf"},
    {"id":"62846","name":"P/0079/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for inotuzumab ozogamicin (Besponsa), (EMEA-001429-PIP01-13-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T15:04:25Z","last_updated_date":"2024-04-05T15:04:25Z","reference_number":"EMA/74598/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-inotuzumab-ozogamicin-besponsa-emea-001429-pip01-13-m07_en.pdf"},
    {"id":"62847","name":"P/0103/2023 : EMA decision of 24 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for defatted powder of peanuts (PALFORZIA), (EMEA-001734-PIP01-14-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T15:29:48Z","last_updated_date":"2024-04-05T15:29:48Z","reference_number":"EMA/130959/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2023-ema-decision-24-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-defatted-powder-peanuts-palforzia-emea-001734-pip01-14-m06_en.pdf"},
    {"id":"62848","name":"P/0078/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for begelomab (EMEA- 001744-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T15:51:10Z","last_updated_date":"2024-04-05T15:51:10Z","reference_number":"EMA/74601/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-begelomab-emea-001744-pip01-14-m02_en.pdf"},
    {"id":"62845","name":"P/0071/2023 : EMA decision of 10 March 2023 on the acceptance of a modification of an agreed paediatric investigation plan for estetrol / drospirenone (Lydisilka, Drovelis and associated names), (EMEA-001332-PIP01-12-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T14:39:28Z","last_updated_date":"2024-04-05T14:39:28Z","reference_number":"EMA/85010/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2023-ema-decision-10-march-2023-acceptance-modification-agreed-paediatric-investigation-plan-estetrol-drospirenone-lydisilka-drovelis-associated-names-emea-001332-pip01-12-m06_en.pdf"},
    {"id":"62838","name":"P/0094/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obecabtagene autoleucel (EMEA-003171-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-04-05T11:57:22Z","last_updated_date":"2024-04-05T11:57:22Z","reference_number":"EMA/66808/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-obecabtagene-autoleucel-emea-003171-pip01-21_en.pdf"},
    {"id":"51662","name":"P/0279/2020: EMA decision of 24 July 2020 on the acceptance of a modification of an agreed paediatric investigation plan for imipenem (monohydrate) / cilastatin (sodium) / relebactam (MK-7655A) (Recarbrio), (EMEA-001809-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-06-29T15:30:00Z","last_updated_date":"2021-06-29T15:30:00Z","reference_number":"EMA/371377/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0279-2020-ema-decision-24-july-2020-acceptance-modification-agreed-paediatric-investigation-plan-imipenem-monohydrate-cilastatin-sodium-relebactam-mk-7655a-recarbrio-emea-001809-pip01-15-m02_en.pdf"},
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    {"id":"62844","name":"P/0099/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for clazakizumab, (EMEA-001371-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T14:39:03Z","last_updated_date":"2024-04-05T14:39:03Z","reference_number":"EMA/65227/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0099-2023-ema-decision-10-march-2023-granting-product-specific-waiver-clazakizumab-emea-001371-pip03-22_en.pdf"},
    {"id":"62842","name":"P/0096/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T14:20:44Z","last_updated_date":"2024-04-05T14:20:44Z","reference_number":"EMA/65237/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0096-2023-ema-decision-10-march-2023-granting-product-specific-waiver-pembrolizumab-keytruda-emea-001474-pip03-22_en.pdf"},
    {"id":"62840","name":"P/0089/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for sotorasib (Lumykras), (EMEA-002690-PIP02-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T14:04:20Z","last_updated_date":"2024-04-05T14:04:20Z","reference_number":"EMA/74651/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2023-ema-decision-10-march-2023-granting-product-specific-waiver-sotorasib-lumykras-emea-002690-pip02-22_en.pdf"},
    {"id":"62837","name":"P/0064/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for insulin lispro (BC222), (EMEA-003166-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T11:39:10Z","last_updated_date":"2024-04-05T11:39:10Z","reference_number":"EMA/77087/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-insulin-lispro-bc222-emea-003166-pip01-21_en.pdf"},
    {"id":"62836","name":"P/0072/2023 : EMA decision of 10 March 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for humanised IgG2 monoclonal antibody against interleukin-6 (RO7200220) (EMEA-003215-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-04-05T11:33:11Z","last_updated_date":"2024-04-05T11:33:11Z","reference_number":"P/0072/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2023-ema-decision-10-march-2023-agreement-paediatric-investigation-plan-granting-waiver-humanised-igg2-monoclonal-antibody-against-interleukin-6-ro7200220-emea-003215-pip01-22_en.pdf"},
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    {"id":"62133","name":"P/0041/2023: EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2'-MOE antisense oligonucleotide targeting apoC-III (ISIS 678354) (EMEA-003177-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-02-14T13:57:45Z","last_updated_date":"2024-02-14T13:57:45Z","reference_number":"EMA/950366/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0041-2023-ema-decision-31-january-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2-moe-antisense-oligonucleotide-targeting-apoc-iii-isis-678354-emea-003177-pip01-21_en.pdf"},
    {"id":"62126","name":"P/0023/2023: EMA decision of 31 January 2023 on n the agreement of a paediatric investigation plan for avexitide (acetate) (EMEA-003125-PIP02-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-02-13T16:28:53Z","last_updated_date":"2024-02-13T16:28:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2023-ema-decision-31-january-2023-n-agreement-paediatric-investigation-plan-avexitide-acetate-emea-003125-pip02-21_en.pdf"},
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    {"id":"62090","name":"P/0018/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for SARS-CoV-2 virus, beta-propiolactone inactivated adjuvanted with CpG 1018 (VLA2001) (COVID-19 Vaccine (inactivated, adjuvanted","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-02-13T11:26:34Z","last_updated_date":"2024-02-13T11:26:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-sars-cov-2-virus-beta-propiolactone-inactivated-adjuvanted-cpg-1018-vla2001-covid-19-vaccine_en.pdf"},
    {"id":"62089","name":"P/0028/2023 : EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for satralizumab (Enspryng), (EMEA-001625-PIP04-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-02-13T11:13:13Z","last_updated_date":"2024-02-13T11:13:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2023-ema-decision-31-january-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-satralizumab-enspryng-emea-001625-pip04-22_en.pdf"},
    {"id":"62016","name":"P/0033/2023 : EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tirzepatide (Mounjaro) (EMEA-002360-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-02-06T15:28:34Z","last_updated_date":"2024-02-06T15:28:34Z","reference_number":"EMA/PDCO/781854/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2023-ema-decision-31-january-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tirzepatide-mounjaro-emea-002360-pip02-22_en.pdf"},
    {"id":"62015","name":"P/0013/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP09-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-02-06T15:22:09Z","last_updated_date":"2024-02-06T15:22:09Z","reference_number":"EMA/18446/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2023-ema-decision-31-january-2023-granting-product-specific-waiver-efgartigimod-alfa-vyvgart-emea-002597-pip09-22_en.pdf"},
    {"id":"61744","name":"P/0015/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for landiolol (hydrochloride) (Rapibloc, Landiobloc, Raploc, Runrapiq), (EMEA-001150-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T17:05:42Z","last_updated_date":"2024-01-11T17:05:42Z","reference_number":"EMA/18675/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2023-ema-decision-31-january-2023-granting-product-specific-waiver-landiolol-hydrochloride-rapibloc-landiobloc-raploc-runrapiq-emea-001150-pip03-22_en.pdf"},
    {"id":"61735","name":"P/0022/2023 ; EMA decision of 31 January 2023 on the granting of a product specific waiver for diclofenac / thiocolchicoside (EMEA-003339-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T14:50:40Z","last_updated_date":"2024-01-11T14:50:40Z","reference_number":"EMA/30270/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2023-ema-decision-31-january-2023-granting-product-specific-waiver-diclofenac-thiocolchicoside-emea-003339-pip01-22_en.pdf"},
    {"id":"61733","name":"P/0044/2023 : EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for troriluzole (hydrochloride) (EMEA-003084-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T14:41:51Z","last_updated_date":"2024-01-11T14:41:51Z","reference_number":"EMA/34175/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2023-ema-decision-31-january-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-troriluzole-hydrochloride-emea-003084-pip03-22_en.pdf"},
    {"id":"61730","name":"P/0101/2023 : EMA decision of 10 March 2023 on the granting of a product specific waiver for finasteride / doxazosin (mesylate) (EMEA-003380-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T14:21:03Z","last_updated_date":"2024-01-11T14:21:03Z","reference_number":"EMA/108879/2023 Corr1","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2023-ema-decision-10-march-2023-granting-product-specific-waiver-finasteride-doxazosin-mesylate-emea-003380-pip01-22_en.pdf"},
    {"id":"61728","name":"P/0011/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for ziltivekimab (EMEA-002840-PIP02-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T14:16:08Z","last_updated_date":"2024-01-11T14:16:08Z","reference_number":"EMA/29535/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2023-ema-decision-31-january-2023-granting-product-specific-waiver-ziltivekimab-emea-002840-pip02-22_en.pdf"},
    {"id":"61727","name":"P/0195/2023 : EMA decision of 15 May 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein F stab","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-01-11T14:10:04Z","last_updated_date":"2024-01-11T14:10:04Z","reference_number":"EMA/210025/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2023-ema-decision-15-may-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-single-stranded-5-capped-mrna-encoding-respiratory-syncytial-virus-glycoprotein-f-stab_en.pdf"},
    {"id":"61726","name":"P/0014/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for retifanlimab (EMEA-002798-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T14:08:58Z","last_updated_date":"2024-01-11T14:08:58Z","reference_number":"EMA/18575/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2023-ema-decision-31-january-2023-granting-product-specific-waiver-retifanlimab-emea-002798-pip03-22_en.pdf"},
    {"id":"61722","name":"P/0025/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for eftilagimod alpha (EMEA-002698-PIP02-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:45:04Z","last_updated_date":"2024-01-11T13:45:04Z","reference_number":"EMA/18755/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2023-ema-decision-31-january-2023-granting-product-specific-waiver-eftilagimod-alpha-emea-002698-pip02-22_en.pdf"},
    {"id":"61724","name":"P/0026/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for eftilagimod alpha (EMEA-002698-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T13:55:04Z","last_updated_date":"2024-01-11T13:55:04Z","reference_number":"EMA/18865/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2023-ema-decision-31-january-2023-granting-product-specific-waiver-eftilagimod-alpha-emea-002698-pip03-22_en.pdf"},
    {"id":"61720","name":"P/0019/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for zuranolone (EMEA- 003119-PIP01-21-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T11:48:57Z","last_updated_date":"2024-01-11T11:48:57Z","reference_number":"EMA/19428/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-zuranolone-emea-003119-pip01-21-m01_en.pdf"},
    {"id":"61719","name":"P/0030/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for galcanezumab (Emgality), (EMEA-001860-PIP03-16-M08)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T11:40:05Z","last_updated_date":"2024-01-11T11:40:05Z","reference_number":"EMA/21183/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-galcanezumab-emgality-emea-001860-pip03-16-m08_en.pdf"},
    {"id":"61718","name":"P/0029/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T11:30:41Z","last_updated_date":"2024-01-11T11:30:41Z","reference_number":"EMA/21182/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0029-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-darunavir-cobicistat-emtricitabine-tenofovir-alafenamide-symtuza-emea-001825-pip01-15-m04_en.pdf"},
    {"id":"61717","name":"P/0027/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir (sulphate) / cobicistat (Evotaz), (EMEA-001465-PIP01-13-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2024-01-11T09:32:41Z","last_updated_date":"2024-01-11T09:32:41Z","reference_number":"EMA/21181/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-atazanavir-sulphate-cobicistat-evotaz-emea-001465-pip01-13-m05_en.pdf"},
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    {"id":"60909","name":"P/0522/2022: EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanized monoclonal IgG1-based antibody (RO7204239) (EMEA-003100- PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T16:36:00Z","last_updated_date":"2023-11-13T16:36:00Z","reference_number":"EMA/929802/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0522-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-humanized-monoclonal-igg1-based-antibody-ro7204239-emea-003100-pip01-21_en.pdf"},
    {"id":"60907","name":"P/0504/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine / lamivudine / tenofovir disoproxil (fumarate) (Delstrigo), (EMEA-001695-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:37:00Z","last_updated_date":"2023-11-13T14:37:00Z","reference_number":"EMA/876007/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0504-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-doravirine-lamivudine-tenofovir-disoproxil-fumarate-delstrigo-emea-001695-pip01-14-m05_en.pdf"},
    {"id":"60906","name":"P/0505/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine (Pifeltro), (EMEA-001676-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:31:00Z","last_updated_date":"2023-11-13T14:31:00Z","reference_number":"EMA/876006/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0505-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-doravirine-pifeltro-emea-001676-pip01-14-m05_en.pdf"},
    {"id":"60905","name":"P/0487/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for encorafenib (Braftovi), (EMEA-001588-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:27:00Z","last_updated_date":"2023-11-13T14:27:00Z","reference_number":"EMA/871494/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0487-2022-ema-decision-2-december-2022-refusal-modification-agreed-paediatric-investigation-plan-encorafenib-braftovi-emea-001588-pip01-13-m02_en.pdf"},
    {"id":"60904","name":"P/0541/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP04-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:21:00Z","last_updated_date":"2023-11-13T14:21:00Z","reference_number":"EMA/876005/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0541-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-dupixent-emea-001501-pip04-19-m02_en.pdf"},
    {"id":"60903","name":"P/0488/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for binimetinib (Mektovi), (EMEA-001454-PIP03-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:16:00Z","last_updated_date":"2023-11-13T14:16:00Z","reference_number":"EMA/871493/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0488-2022-ema-decision-2-december-2022-refusal-modification-agreed-paediatric-investigation-plan-binimetinib-mektovi-emea-001454-pip03-15-m02_en.pdf"},
    {"id":"60902","name":"P/0540/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tecovirimat  (monohydrate) (Tecovirimat SIGA), (EMEA-001205-PIP02-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:12:00Z","last_updated_date":"2023-11-13T14:12:00Z","reference_number":"EMA/876002/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0540-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-tecovirimat-monohydrate-tecovirimat-siga-emea-001205-pip02-19-m02_en.pdf"},
    {"id":"60901","name":"P/0489/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human  A disintegrin and metalloprotease with thrombospondin type-1 Motifs 13 (EMEA-001160-PIP01-11- M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T14:01:00Z","last_updated_date":"2023-11-13T14:01:00Z","reference_number":"EMA/871491/2022 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0489-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-disintegrin-metalloprotease-thrombospondin-type-1-motifs-13-emea-001160-pip01-11_en.pdf"},
    {"id":"60900","name":"P/0528/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima,  Kisplyx), (EMEA-001119-PIP03-19-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:47:00Z","last_updated_date":"2023-11-13T13:47:00Z","reference_number":"EMA/929776/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0528-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-lenvatinib-lenvima-kisplyx-emea-001119-pip03-19-m03_en.pdf"},
    {"id":"60899","name":"P/0490/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brodalumab (Kyntheum), (EMEA-001089-PIP02-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:40:00Z","last_updated_date":"2023-11-13T13:40:00Z","reference_number":"EMA/871488/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0490-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-brodalumab-kyntheum-emea-001089-pip02-13-m03_en.pdf"},
    {"id":"60898","name":"P/0533/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan for posoleucel (EMEA-002908-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:35:00Z","last_updated_date":"2023-11-13T13:35:00Z","reference_number":"EMA/930300/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0533-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-posoleucel-emea-002908-pip01-20_en.pdf"},
    {"id":"60897","name":"P/0521/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for live, attenuated, dengue virus, serotype 1 (DENV1), live, attenuated, chimeric dengue","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:28:00Z","last_updated_date":"2023-11-13T13:28:00Z","reference_number":"EMA/915714/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0521-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-live-attenuated-dengue-virus-serotype-1-denv1-live-attenuated-chimeric-dengue_en.pdf"},
    {"id":"60896","name":"P/0498/2022 : EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for manganese chloride tetrahydrate (EMEA-003035-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:22:00Z","last_updated_date":"2023-11-13T13:22:00Z","reference_number":"EMA/853941/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0498-2022-ema-decision-2-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-manganese-chloride-tetrahydrate-emea-003035-pip02-21_en.pdf"},
    {"id":"60895","name":"P/0543/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for depemokimab (EMEA-003051-PIP04-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:17:00Z","last_updated_date":"2023-11-13T13:17:00Z","reference_number":"EMA/876016/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0543-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-depemokimab-emea-003051-pip04-22_en.pdf"},
    {"id":"60894","name":"P/0544/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for enzastaurin (hydrochloride) (EMEA-003096-PIP02-22)","type":"pip-decision","status":"Draft","consultation_date":"","first_published_date":"2023-11-13T13:12:00Z","last_updated_date":"2023-11-13T13:12:00Z","reference_number":"EMA/876030/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0544-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-waiver-enzastaurin-hydrochloride-emea-003096-pip02-22_en.pdf"},
    {"id":"60893","name":"P/0523/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for HIV-1 maturation inhibitor (GSK3640254) / dolutegravir (EMEA-003152- PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T13:06:00Z","last_updated_date":"2023-11-13T13:06:00Z","reference_number":"EMA/929803/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0523-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-hiv-1-maturation-inhibitor-gsk3640254-dolutegravir-emea-003152-pip01-21_en.pdf"},
    {"id":"60891","name":"P/0529/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella), (EMEA-000927-PIP01-10-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T12:42:00Z","last_updated_date":"2023-11-13T12:42:00Z","reference_number":"EMA/929775/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0529-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-linaclotide-constella-emea-000927-pip01-10-m07_en.pdf"},
    {"id":"60889","name":"P/0483/2022: EMA decision of 2 December 2022 on the granting of a product specific waiver for lacutamab (EMEA-003281-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T12:04:00Z","last_updated_date":"2023-11-13T12:04:00Z","reference_number":"EMA/871506/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0483-2022-ema-decision-2-december-2022-granting-product-specific-waiver-lacutamab-emea-003281-pip01-22_en.pdf"},
    {"id":"60888","name":"P/0493/2022: EMA decision of 2 December 2022 on the granting of a product specific waiver for 1-{6-[(4M)-4-(5-Chloro-6-methyl-1H-indazol-4-yl)-5- methyl-3-(1-methyl-1H-indazol-5-yl)-1Hpyrazol- 1-yl]-2-azaspiro[3.3] [..] (EMEA-003278-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T11:54:00Z","last_updated_date":"2023-11-13T11:54:00Z","reference_number":"EMA/853387/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0493-2022-ema-decision-2-december-2022-granting-product-specific-waiver-1-6-4m-4-5-chloro-6-methyl-1h-indazol-4-yl-5-methyl-3-1-methyl-1h-indazol-5-yl-1hpyrazol-1-yl-2-azaspiro33-emea-003278-pip01_en.pdf"},
    {"id":"60887","name":"P/0471/2022: EMA decision of 1 December 2022 on  the granting of a product specific waiver for namilumab (EMEA-003275-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T11:46:00Z","last_updated_date":"2023-11-13T11:46:00Z","reference_number":"EMA/897866/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0471-2022-ema-decision-1-december-2022-granting-product-specific-waiver-namilumab-emea-003275-pip01-22_en.pdf"},
    {"id":"60886","name":"P/0511/2022: EMA decision of 2 December 2023 on the granting of a product specific waiver for tigulixostat (EMEA-003272-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T11:35:00Z","last_updated_date":"2023-11-13T11:35:00Z","reference_number":"EMA/898522/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0511-2022-ema-decision-2-december-2023-granting-product-specific-waiver-tigulixostat-emea-003272-pip01-22_en.pdf"},
    {"id":"60884","name":"P/0514/2022 : EMA decision of 6 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (ABT- 494) (Rinvoq), (EMEA-001741-PIP02-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T11:13:00Z","last_updated_date":"2023-11-13T11:13:00Z","reference_number":"EMA/911625/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0514-2022-ema-decision-6-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-abt-494-rinvoq-emea-001741-pip02-16-m02_en.pdf"},
    {"id":"60883","name":"P/0496/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T11:07:00Z","last_updated_date":"2023-11-13T11:07:00Z","reference_number":"EMA/852155/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0496-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-dolutegravir-juluca-emea-001750-pip01-15-m06_en.pdf"},
    {"id":"60881","name":"P/0517/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for imetelstat (EMEA- 001910-PIP03-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T10:52:00Z","last_updated_date":"2023-11-13T10:52:00Z","reference_number":"EMA/911953/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0517-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-imetelstat-emea-001910-pip03-20-m01_en.pdf"},
    {"id":"60880","name":"P/0515/2022 : EMA decision of 6 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for odevixibat (Bylvay), (EMEA-002054-PIP03-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T10:41:00Z","last_updated_date":"2023-11-13T10:41:00Z","reference_number":"EMA/912385/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0515-2022-ema-decision-6-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-odevixibat-bylvay-emea-002054-pip03-20-m02_en.pdf"},
    {"id":"60879","name":"P/0518/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for entospletinib (EMEA- 002058-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T10:36:00Z","last_updated_date":"2023-11-13T10:36:00Z","reference_number":"EMA/912437/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0518-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-entospletinib-emea-002058-pip01-16-m01_en.pdf"},
    {"id":"60878","name":"P/0535/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lefamulin (Xenleta) (EMEA-002075-PIP01-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T10:32:00Z","last_updated_date":"2023-11-13T10:32:00Z","reference_number":"EMA/901112/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0535-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-lefamulin-xenleta-emea-002075-pip01-16-m03_en.pdf"},
    {"id":"60877","name":"P/0470/2022 : EMA decision of of 16 November 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bedaquiline (fumarate) (Sirturo), (EMEA-000912-PIP01-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T09:57:00Z","last_updated_date":"2023-11-13T09:57:00Z","reference_number":"EMA/884378/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0470-2022-ema-decision-16-november-2022-acceptance-modification-agreed-paediatric-investigation-plan-bedaquiline-fumarate-sirturo-emea-000912-pip01-10-m06_en.pdf"},
    {"id":"60876","name":"P/0467/2022 : EMA decision of 17 November 2022 on the acceptance of a modification of an agreed paediatric investigation plan for glycopyrronium bromide (EMEA-002383-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-13T09:44:00Z","last_updated_date":"2023-11-13T09:44:00Z","reference_number":"EMA/873549/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0467-2022-ema-decision-17-november-2022-acceptance-modification-agreed-paediatric-investigation-plan-glycopyrronium-bromide-emea-002383-pip01-18-m02_en.pdf"},
    {"id":"60592","name":"P/0171/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / tenofovir alafenamide (Descovy), (EMEA-001577-PIP02-14-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T09:23:00Z","last_updated_date":"2018-11-28T09:23:00Z","reference_number":"EMA/352390/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-emtricitabine-tenofovir-alafenamide-descovy-emea-001577-pip02-14-m03_en.pdf"},
    {"id":"60864","name":"P/0502/2022 : EMA decision of 1 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP06-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:45:00Z","last_updated_date":"2023-11-10T13:45:00Z","reference_number":"EMA/901090/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0502-2022-ema-decision-1-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-obinutuzumab-gazyvaro-emea-001207-pip06-22_en.pdf"},
    {"id":"60863","name":"P/0545/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for inclacumab (EMEA-003219-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:39:00Z","last_updated_date":"2023-11-10T13:39:00Z","reference_number":"EMA/876031/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0545-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-inclacumab-emea-003219-pip01-22_en.pdf"},
    {"id":"60862","name":"P/0525/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for treprostinil (palmitil) (EMEA-003204-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:35:00Z","last_updated_date":"2023-11-10T13:35:00Z","reference_number":"EMA/929791/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0525-2022-ema-decision-30-december-2022-granting-product-specific-waiver-treprostinil-palmitil-emea-003204-pip01-22_en.pdf"},
    {"id":"60861","name":"P/0486/2022 : EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ruxolitinib (phosphate) (Jakavi), (EMEA-002618-PIP03-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:27:00Z","last_updated_date":"2023-11-10T13:27:00Z","reference_number":"EMA/871497/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0486-2022-ema-decision-2-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ruxolitinib-phosphate-jakavi-emea-002618-pip03-21_en.pdf"},
    {"id":"60860","name":"P/0509/2022 : EMA decision of 2 December 2022 on the granting of a product specific waiver for nipocalimab (EMEA-002559-PIP06-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:20:00Z","last_updated_date":"2023-11-10T13:20:00Z","reference_number":"EMA/898521/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0509-2022-ema-decision-2-december-2022-granting-product-specific-waiver-nipocalimab-emea-002559-pip06-22_en.pdf"},
    {"id":"60859","name":"P/0472/2022 : EMA decision of 1 December 2022 on the granting of a product specific waiver for pemigatinib (Pemazyre), (EMEA-002370-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:13:00Z","last_updated_date":"2023-11-10T13:13:00Z","reference_number":"EMA/897884/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0472-2022-ema-decision-1-december-2022-granting-product-specific-waiver-pemigatinib-pemazyre-emea-002370-pip03-22_en.pdf"},
    {"id":"60858","name":"P/0481/2022 : EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for semaglutide (EMEA-001441-PIP07-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-11-10T13:05:00Z","last_updated_date":"2023-11-10T13:05:00Z","reference_number":"EMA/899044/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0481-2022-ema-decision-2-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-semaglutide-emea-001441-pip07-21_en.pdf"},
    {"id":"60844","name":"P/0479/2022: EMA decision of 2 December 2022 on the granting of a product specific waiver for 2-{4-[4-(4-{5-[(1S)-1-amino-1-(4-fluorophenyl) ethyl]pyrimidin-2-yl}piperazin-1-yl)pyrrolo[2,1-f] [...](EMEA-003269-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-10T11:38:00Z","last_updated_date":"2023-11-10T11:38:00Z","reference_number":"EMA/899042/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0479-2022-ema-decision-2-december-2022-granting-product-specific-waiver-2-4-4-4-5-1s-1-amino-1-4-fluorophenyl-ethylpyrimidin-2-ylpiperazin-1-ylpyrrolo21-f-emea-003269-pip01-22_en.pdf"},
    {"id":"60843","name":"P/0520/2022: EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for stiripentol (EMEA-003200-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-10T11:15:00Z","last_updated_date":"2023-11-10T11:15:00Z","reference_number":"EMA/915926/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0520-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-stiripentol-emea-003200-pip01-22_en.pdf"},
    {"id":"60835","name":"P/0519/2022 : EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obefazimod (EMEA-003196-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T17:45:00Z","last_updated_date":"2023-11-09T17:45:00Z","reference_number":"EMA/915818/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0519-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-obefazimod-emea-003196-pip01-22_en.pdf"},
    {"id":"60833","name":"P/0057/2023 : EMA decision of 24 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for methylphenidate (hydrochloride) (EMEA-003189-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:45:00Z","last_updated_date":"2023-11-09T15:45:00Z","reference_number":"EMA/21175/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2023-ema-decision-24-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-methylphenidate-hydrochloride-emea-003189-pip01-22-m01_en.pdf"},
    {"id":"60832","name":"P/0017/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor....(EMEA-002886-PIP01-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:40:00Z","last_updated_date":"2023-11-09T15:40:00Z","reference_number":"EMA/19115/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-human-recombinant-non-fucosylated-igg1k-monoclonal-antibody-targeting-ox-40-receptoremea-002886_en.pdf"},
    {"id":"60830","name":"P/0016/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for evoncabtagene pazurgedleucel (EMEA-002881-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:34:00Z","last_updated_date":"2023-11-09T15:34:00Z","reference_number":"EMA/18982/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2023-ema-decision-31-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-evoncabtagene-pazurgedleucel-emea-002881-pip01-20-m01_en.pdf"},
    {"id":"60829","name":"P/0055/2023 : EMA decision of 30 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for neisseria meningitidis serogroup B fHbp subfamily A / Neisseria meningitidis group C....(EMEA-002814-PIP02-21- M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:26:00Z","last_updated_date":"2023-11-09T15:26:00Z","reference_number":"EMA/21391/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2023-ema-decision-30-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-neisseria-meningitidis-serogroup-b-fhbp-subfamily-neisseria-meningitidis-group-cemea-002814-pip02_en.pdf"},
    {"id":"60828","name":"P/0058/2023 : EMA decision of 24 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for respiratory syncytial virus stabilised prefusion F subunit vaccine (EMEA-002795-PIP02-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:20:00Z","last_updated_date":"2023-11-09T15:20:00Z","reference_number":"EMA/36508/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2023-ema-decision-24-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-respiratory-syncytial-virus-stabilised-prefusion-f-subunit-vaccine-emea-002795-pip02-21-m01_en.pdf"},
    {"id":"60827","name":"P/0046/2023 : EMA decision of 24 January 2021 on the acceptance of a modification of an agreed paediatric investigation plan for exagamglogene autotemcel (EMEA-002730-PIP04-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:13:00Z","last_updated_date":"2023-11-09T15:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2023-ema-decision-24-january-2021-acceptance-modification-agreed-paediatric-investigation-plan-exagamglogene-autotemcel-emea-002730-pip04-21-m01_en.pdf"},
    {"id":"60826","name":"P/0048/2023 : EMA decision of 30 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for garadacimab (EMEA- 002726-PIP01-19-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T15:04:00Z","last_updated_date":"2023-11-09T15:04:00Z","reference_number":"EMA/21395/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0048-2023-ema-decision-30-january-2023-acceptance-modification-agreed-paediatric-investigation-plan-garadacimab-emea-002726-pip01-19-m03_en.pdf"},
    {"id":"60823","name":"P/0036/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for diclofenac / orphenadrine (citrate) (EMEA-003337- PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T14:44:00Z","last_updated_date":"2023-11-09T14:44:00Z","reference_number":"EMA/21196/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2023-ema-decision-31-january-2023-granting-product-specific-waiver-diclofenac-orphenadrine-citrate-emea-003337-pip01-22_en.pdf"},
    {"id":"60821","name":"P/0043/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for tetanus toxoid (Tetana) (EMEA-003311-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T14:36:00Z","last_updated_date":"2023-11-09T14:36:00Z","reference_number":"EMA/950370/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2023-ema-decision-31-january-2023-granting-product-specific-waiver-tetanus-toxoid-tetana-emea-003311-pip01-22_en.pdf"},
    {"id":"60820","name":"P/0032/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for setanaxib (EMEA-003310-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T14:26:00Z","last_updated_date":"2023-11-09T14:26:00Z","reference_number":"EMA/21189/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2023-ema-decision-31-january-2023-granting-product-specific-waiver-setanaxib-emea-003310-pip01-22_en.pdf"},
    {"id":"60819","name":"P/0042/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for rivaroxaban + acetylsalicylic acid1 (EMEA-003308-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T14:17:00Z","last_updated_date":"2023-11-09T14:17:00Z","reference_number":"EMA/950368/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2023-ema-decision-31-january-2023-granting-product-specific-waiver-rivaroxaban-acetylsalicylic-acid1-emea-003308-pip01-22_en.pdf"},
    {"id":"60815","name":"P/0001/2023 : EMA decision of 12 January 2023 on the granting of a product specific waiver for rosuvastatin (calcium) / fenofibrate (EMEA-003295-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T13:52:00Z","last_updated_date":"2023-11-09T13:52:00Z","reference_number":"EMA/876033/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2023-ema-decision-12-january-2023-granting-product-specific-waiver-rosuvastatin-calcium-fenofibrate-emea-003295-pip01-22_en.pdf"},
    {"id":"60814","name":"P/0035/2023 : EMA decision of 31 January 2023 on the granting of a product specific waiver for diclofenac (sodium) / thiamine (hydrochloride) / pyridoxine (hydrochloride) / cyanocobalamin (EMEA-003292-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-11-09T13:45:00Z","last_updated_date":"2023-11-09T13:45:00Z","reference_number":"EMA/21199/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0035-2023-ema-decision-31-january-2023-granting-product-specific-waiver-diclofenac-sodium-thiamine-hydrochloride-pyridoxine-hydrochloride-cyanocobalamin-emea-003292-pip02-22_en.pdf"},
    {"id":"60497","name":"P/0480/2022: EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sirolimus (EMEA-003168-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-26T15:56:00Z","last_updated_date":"2023-10-26T15:56:00Z","reference_number":"EMA/899045/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0480-2022-ema-decision-2-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sirolimus-emea-003168-pip01-21_en.pdf-0"},
    {"id":"60496","name":"P/0510/2022: EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for emactuzumab (EMEA-003172-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-26T15:47:00Z","last_updated_date":"2023-10-26T15:47:00Z","reference_number":"EMA/898536/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0510-2022-ema-decision-2-december-2022-agreement-paediatric-investigation-plan-granting-waiver-emactuzumab-emea-003172-pip01-21_en.pdf"},
    {"id":"60495","name":"P/0546/2022: EMA decision of 30 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pridopidine (hydrochloride) (EMEA-003174-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-26T15:32:00Z","last_updated_date":"2023-10-26T15:32:00Z","reference_number":"EMA/934635/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0546-2022-ema-decision-30-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pridopidine-hydrochloride-emea-003174-pip01-21_en.pdf"},
    {"id":"60494","name":"P/0475/2022: EMA decision of 1 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for exenatide (acetate), (EMEA-003183-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-26T14:56:00Z","last_updated_date":"2023-10-26T14:56:00Z","reference_number":"EMA/898079/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0475-2022-ema-decision-1-december-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-exenatide-acetate-emea-003183-pip02-22_en.pdf"},
    {"id":"60493","name":"P/0512/2022: EMA decision of 2 December2022 on the granting of a product specific waiver for cobolimab (EMEA-003273-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-26T14:44:00Z","last_updated_date":"2023-10-26T14:44:00Z","reference_number":"EMA/898523/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0512-2022-ema-decision-2-december2022-granting-product-specific-waiver-cobolimab-emea-003273-pip01-22_en.pdf"},
    {"id":"60489","name":"P/0507/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for lanthanum carbonate hydrate (Fosrenol), (EMEA-000637-PIP02-10-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-25T16:01:00Z","last_updated_date":"2023-10-25T16:01:00Z","reference_number":"EMA/898472/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0507-2022-ema-decision-2-december-2022-refusal-modification-agreed-paediatric-investigation-plan-lanthanum-carbonate-hydrate-fosrenol-emea-000637-pip02-10-m07_en.pdf"},
    {"id":"60486","name":"P/0548/2022: EMA decision of 30 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of birch, alder and hazel pollen (EMEA-000","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-25T15:19:00Z","last_updated_date":"2023-10-25T15:19:00Z","reference_number":"EMA/934709/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0548-2022-ema-decision-30-december-2022-refusal-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-birch-alder_en.pdf"},
    {"id":"60485","name":"P/0531/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for siponimod (hemifumarate) (Mayzent), (EMEA-000716-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-25T14:54:00Z","last_updated_date":"2023-10-25T14:54:00Z","reference_number":"EMA/929763/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0531-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-siponimod-hemifumarate-mayzent-emea-000716-pip01-09-m05_en.pdf"},
    {"id":"60483","name":"P/0527/2022: EMA decision of 30 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of birch pollen (EMEA-000837- PIP01-10-M02","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-25T14:14:00Z","last_updated_date":"2023-10-25T14:14:00Z","reference_number":"EMA/929767/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0527-2022-ema-decision-30-december-2022-refusal-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-birch-pollen_en.pdf"},
    {"id":"32765","name":"P/0004/2012: EMA decision of 23 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of bi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/972925/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2012-ema-decision-23-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-bi_en.pdf"},
    {"id":"60482","name":"P/0526/2022: EMA decision of 30 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of birch, alder and hazel pollen (EMEA-000","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-25T14:06:00Z","last_updated_date":"2023-10-25T14:06:00Z","reference_number":"EMA/929772/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0526-2022-ema-decision-30-december-2022-refusal-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-birch-alder_en.pdf"},
    {"id":"60477","name":"P/0538/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for ezeprogind (EMEA-003320-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-24T14:26:00Z","last_updated_date":"2023-10-24T14:26:00Z","reference_number":"EMA/931324/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0538-2022-ema-decision-30-december-2022-granting-product-specific-waiver-ezeprogind-emea-003320-pip01-22_en.pdf"},
    {"id":"60476","name":"P/0532/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for messenger RNA encoding Cas9 and single guide RNA targeting the human TTR gene (EMEA-003298-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-24T14:15:00Z","last_updated_date":"2023-10-24T14:15:00Z","reference_number":"EMA/929798/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0532-2022-ema-decision-30-december-2022-granting-product-specific-waiver-messenger-rna-encoding-cas9-single-guide-rna-targeting-human-ttr-gene-emea-003298-pip01-22_en.pdf"},
    {"id":"60475","name":"P/0534/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for eplontersen (EMEA-003294-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-24T13:10:00Z","last_updated_date":"2023-10-24T13:10:00Z","reference_number":"EMA/930232/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0534-2022-ema-decision-30-december-2022-granting-product-specific-waiver-eplontersen-emea-003294-pip01-22_en.pdf"},
    {"id":"60474","name":"P/0499/2022 : EMA decision of 2 December 2022 on the granting of a product specific waiver for diclofenac (potassium) / thiamine (hydrochloride) / pyridoxine (hydrochloride) / cyanocobalamin (EMEA-003292-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-24T13:05:00Z","last_updated_date":"2023-10-24T13:05:00Z","reference_number":"EMA/853429/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0499-2022-ema-decision-2-december-2022-granting-product-specific-waiver-diclofenac-potassium-thiamine-hydrochloride-pyridoxine-hydrochloride-cyanocobalamin-emea-003292-pip01-22_en.pdf"},
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    {"id":"60471","name":"P/0547/2022 : EMA decision of 30 December 2022 on the granting of a product specific waiver for valsartan / indapamide (EMEA-003285-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-24T12:37:00Z","last_updated_date":"2023-10-24T12:37:00Z","reference_number":"EMA/934658/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0547-2022-ema-decision-30-december-2022-granting-product-specific-waiver-valsartan-indapamide-emea-003285-pip01-22_en.pdf"},
    {"id":"60470","name":"P/0482/2022 : EMA decision of 2 December 2022 on the granting of a product specific waiver for 2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indan-2-carboxylic acid (EMEA-003282-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-24T12:25:00Z","last_updated_date":"2023-10-24T12:25:00Z","reference_number":"EMA/871507/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0482-2022-ema-decision-2-december-2022-granting-product-specific-waiver-2-4-methoxy-3-2-m-tolyl-ethoxy-benzoylamino-indan-2-carboxylic-acid-emea-003282-pip01-22_en.pdf"},
    {"id":"9516","name":"P/2/2010: EMA decision on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the refusal of a waiver for (1R,2R,4S)-4-{(2R)-2- [(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-(...)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"EMA/27223/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-2-2010-ema-decision-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-1r2r4s-4-2r-2-3s6r7e9r10r12r14s15e17e19e21s23s26r27r34as-927-dihydroxy-1021_en.pdf"},
    {"id":"60117","name":"(1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27.....(MK-8669, or AP23573) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-09-22T15:03:00Z","last_updated_date":"2023-09-22T15:03:00Z","reference_number":"EMEA-000458-PIP01-08","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/1r2r4s-4-2r-2-3s6r7e9r10r12r14s15e17e19e21s23s26r27r34as-927mk-8669-or-ap23573-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"60198","name":"P/0393/2022 : EMA decision of 9 September 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for clazakizumab (EMEA-001371-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-09-28T16:44:00Z","last_updated_date":"2023-09-28T16:44:00Z","reference_number":"EMA/677940/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0393-2022-ema-decision-9-september-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-clazakizumab-emea-001371-pip02-21_en.pdf"},
    {"id":"60437","name":"P/0503/2022 : EMA decision of 1 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for (1R,2S,5S)-N-((1S)- 1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-....(Paxlovid) (EMEA-003081-PIP01-21-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T16:41:00Z","last_updated_date":"2023-10-13T16:41:00Z","reference_number":"EMA/901099/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0503-2022-ema-decision-1-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-1r2s5s-n-1s-1-cyano-2-3s-2-oxopyrrolidin-3-ylethyl-3-2s-33-paxlovid-emea-003081-pip01-21-m02_en.pdf"},
    {"id":"60435","name":"P/0476/2022 : EMA decision of 1 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for durlobactam / sulbactam (SUL-DUR) (EMEA-002807-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T16:31:00Z","last_updated_date":"2023-10-13T16:31:00Z","reference_number":"EMA/873551/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0476-2022-ema-decision-1-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-durlobactam-sulbactam-sul-dur-emea-002807-pip01-20-m01_en.pdf"},
    {"id":"60434","name":"P/0500/2022 : EMA decision of 1 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gadoquatrane (BAY 1747846) (EMEA-002778-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T16:26:00Z","last_updated_date":"2023-10-13T16:26:00Z","reference_number":"EMA/873552/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0500-2022-ema-decision-1-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-gadoquatrane-bay-1747846-emea-002778-pip01-20-m01_en.pdf"},
    {"id":"60433","name":"P/0537/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ofatumumab (Kesimpta) (EMEA-002397-PIP01-18-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T16:20:00Z","last_updated_date":"2023-10-13T16:20:00Z","reference_number":"EMA/901114/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0537-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-ofatumumab-kesimpta-emea-002397-pip01-18-m03_en.pdf"},
    {"id":"60432","name":"P/0491/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for voxelotor (EMEA- 002356-PIP02-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T16:12:00Z","last_updated_date":"2023-10-13T16:12:00Z","reference_number":"EMA/853094/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0491-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-voxelotor-emea-002356-pip02-20-m01_en.pdf"},
    {"id":"60430","name":"P/0495/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for inclisiran (sodium) (Leqvio) (EMEA-002214-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T16:05:00Z","last_updated_date":"2023-10-13T16:05:00Z","reference_number":"EMA/851986/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0495-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-inclisiran-sodium-leqvio-emea-002214-pip01-17-m01_en.pdf"},
    {"id":"60429","name":"P/0494/2022 : EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for isatuximab (Sarclisa) (EMEA-002205-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T15:58:00Z","last_updated_date":"2023-10-13T15:58:00Z","reference_number":"EMA/851802/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0494-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-isatuximab-sarclisa-emea-002205-pip01-17-m03_en.pdf"},
    {"id":"60428","name":"P/0536/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for setrusumab (EMEA-002169-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T15:52:00Z","last_updated_date":"2023-10-13T15:52:00Z","reference_number":"EMA/901113/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0536-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-setrusumab-emea-002169-pip01-17-m02_en.pdf"},
    {"id":"60427","name":"P/0539/2022 : EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for modified Vaccinia Ankara - Bavarian Nordic virus (smallpox) (Imvanex) (EMEA-001161-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-13T15:47:00Z","last_updated_date":"2023-10-13T15:47:00Z","reference_number":"EMA/876000/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0539-2022-ema-decision-30-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-modified-vaccinia-ankara-bavarian-nordic-virus-smallpox-imvanex-emea-001161-pip02-11-m02_en.pdf"},
    {"id":"60408","name":"P/0549/2022: EMA decision of 30 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised...(EMEA-000630-PIP02-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T17:18:00Z","last_updated_date":"2023-10-12T17:18:00Z","reference_number":"EMA/934749/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0549-2022-ema-decision-30-december-2022-refusal-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerisedemea-000630-pip02-09-m05_en.pdf"},
    {"id":"60407","name":"P/0447/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for levonorgestrel (EMEA-002474-PIP02-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T17:15:00Z","last_updated_date":"2023-10-12T17:15:00Z","reference_number":"EMA/827039/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0447-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-levonorgestrel-emea-002474-pip02-18-m01_en.pdf"},
    {"id":"60406","name":"P/0382/2022 : EMA decision of 10 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for efanesoctocog alfa (EMEA-002501-PIP01-18-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T17:10:00Z","last_updated_date":"2023-10-12T17:10:00Z","reference_number":"EMA/709081/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0382-2022-ema-decision-10-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-efanesoctocog-alfa-emea-002501-pip01-18-m03_en.pdf"},
    {"id":"60405","name":"P/0506/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten), (EMEA-000347-PIP02-16-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T17:07:00Z","last_updated_date":"2023-10-12T17:07:00Z","reference_number":"EMA/898469/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0506-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-emea-000347-pip02-16-m04_en.pdf"},
    {"id":"60404","name":"P/0416/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for atropine (sulphate) (EMEA-002545-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T17:05:00Z","last_updated_date":"2023-10-12T17:05:00Z","reference_number":"EMA/777575/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0416-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-atropine-sulphate-emea-002545-pip01-19-m01_en.pdf"},
    {"id":"60403","name":"P/0478/2022: EMA decision of 2 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for saxagliptin (Onglyza), (EMEA-000200-PIP01-08-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T17:02:00Z","last_updated_date":"2023-10-12T17:02:00Z","reference_number":"EMA/899035/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0478-2022-ema-decision-2-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-saxagliptin-onglyza-emea-000200-pip01-08-m10_en.pdf"},
    {"id":"60401","name":"P/0444/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gepotidacin (EMEA- 002443-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T16:31:00Z","last_updated_date":"2023-10-12T16:31:00Z","reference_number":"EMA/825134/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0444-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-gepotidacin-emea-002443-pip01-18-m01_en.pdf"},
    {"id":"60098","name":"P/0417/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefepime / taniborbactam (EMEA-002576-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-09-21T14:29:00Z","last_updated_date":"2023-09-21T14:29:00Z","reference_number":"EMA/777575/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0417-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-cefepime-taniborbactam-emea-002576-pip01-19-m01_en.pdf"},
    {"id":"60400","name":"P/0477/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T16:16:00Z","last_updated_date":"2023-10-12T16:16:00Z","reference_number":"EMA/899031/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0477-2022-ema-decision-2-december-2022-refusal-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip01-07-m12_en.pdf"},
    {"id":"60399","name":"P/0430/2022 : EMA decision of 28 October 2022 on the granting of a product-specific waiver for fluorine (18F) PSMA-1007 (EMEA-003250-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T16:16:00Z","last_updated_date":"2023-10-12T16:16:00Z","reference_number":"EMA/808660/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0430-2022-ema-decision-28-october-2022-granting-product-specific-waiver-fluorine-18f-psma-1007-emea-003250-pip01-22_en.pdf"},
    {"id":"60398","name":"P/0465/2022: EMA decision of 4 November 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 Vaccine (recombinant, adjuvanted) (EMEA-003191-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T16:09:00Z","last_updated_date":"2023-10-12T16:09:00Z","reference_number":"EMA/853635/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0465-2022-ema-decision-4-november-2022-agreement-paediatric-investigation-plan-granting-deferral-covid-19-vaccine-recombinant-adjuvanted-emea-003191-pip01-22_en.pdf"},
    {"id":"60397","name":"P/0451/2022 : EMA decision of 28 October 2022 on the granting of a product specific waiver for trilaciclib (dihydrochloride) (EMEA-002534-PIP03-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T16:08:00Z","last_updated_date":"2023-10-12T16:08:00Z","reference_number":"EMA/834732/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0451-2022-ema-decision-28-october-2022-granting-product-specific-waiver-trilaciclib-dihydrochloride-emea-002534-pip03-22_en.pdf"},
    {"id":"60396","name":"P/0464/2022 : EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan for beremagene geperpavec (EMEA-002472-PIP03- 22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-10-12T15:58:00Z","last_updated_date":"2023-10-12T15:58:00Z","reference_number":"EMA/790731/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0464-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-beremagene-geperpavec-emea-002472-pip03-22_en.pdf"},
    {"id":"60395","name":"P/0450/2022 : EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ianalumab (EMEA-002338-PIP03-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-10-12T15:51:00Z","last_updated_date":"2023-10-12T15:51:00Z","reference_number":"EMA/834866/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0450-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ianalumab-emea-002338-pip03-21_en.pdf"},
    {"id":"60394","name":"P/0449/2022 : EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for branaplam (EMEA-002204-PIP02-20)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-10-12T15:46:00Z","last_updated_date":"2023-10-12T15:46:00Z","reference_number":"EMA/834865/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0449-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-granting-waiver-branaplam-emea-002204-pip02-20_en.pdf"},
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    {"id":"60388","name":"P/0433/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cenerimod (EMEA-003108-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T14:43:00Z","last_updated_date":"2023-10-12T14:43:00Z","reference_number":"EMA/808582/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0433-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cenerimod-emea-003108-pip01-21_en.pdf"},
    {"id":"60387","name":"P/0469/2022: EMA decision of 14 November 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efavaleukin alfa (EMEA-003156-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T14:28:00Z","last_updated_date":"2023-10-12T14:28:00Z","reference_number":"EMA/884290/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0469-2022-ema-decision-14-november-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-efavaleukin-alfa-emea-003156-pip02-22_en.pdf"},
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    {"id":"60385","name":"P/0425/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for yellow fever virus, strain vYF-247 (EMEA-003030-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T14:21:00Z","last_updated_date":"2023-10-12T14:21:00Z","reference_number":"EMA/825331/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0425-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-granting-waiver-yellow-fever-virus-strain-vyf-247-emea-003030-pip02-21_en.pdf"},
    {"id":"60383","name":"P/0429/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan for recombinant fusion protein linking iduronate 2- sulfatase to engineered Fc with binding site for transferrin receptor (DNL310) (EMEA-002845-PIP01- 20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T14:07:00Z","last_updated_date":"2023-10-12T14:07:00Z","reference_number":"EMA/826865/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0429-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-recombinant-fusion-protein-linking-iduronate-2-sulfatase-engineered-fc-binding-site-transferrin-receptor-dnl310-emea_en.pdf"},
    {"id":"60372","name":"P/0428/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T10:21:00Z","last_updated_date":"2023-10-12T10:21:00Z","reference_number":"EMA/826798/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0428-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-ambrisentan-volibris-emea-000434-pip01-08-m09_en.pdf-0"},
    {"id":"60373","name":"P/0440/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eliglustat (Cerdelga) (EMEA-000461-PIP02-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T10:29:00Z","last_updated_date":"2023-10-12T10:29:00Z","reference_number":"EMA/808128/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0440-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-eliglustat-cerdelga-emea-000461-pip02-11-m05_en.pdf"},
    {"id":"60368","name":"P/0421/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for golimumab (Simponi), (EMEA-000265-PIP02-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T09:06:00Z","last_updated_date":"2023-10-12T09:06:00Z","reference_number":"EMA/825000/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0421-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-golimumab-simponi-emea-000265-pip02-11-m04_en.pdf"},
    {"id":"60370","name":"P/0423/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (Cosentyx), (EMEA-000380-PIP06-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T10:12:00Z","last_updated_date":"2023-10-12T10:12:00Z","reference_number":"EMA/825174/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0423-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-secukinumab-cosentyx-emea-000380-pip06-19-m01_en.pdf"},
    {"id":"60369","name":"P/0424/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ocrelizumab (Ocrevus), (EMEA-000310-PIP03-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T09:14:00Z","last_updated_date":"2023-10-12T09:14:00Z","reference_number":"EMA/825317/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0424-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-ocrelizumab-ocrevus-emea-000310-pip03-10-m06_en.pdf"},
    {"id":"60376","name":"P/0438/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine (Exparel liposomal) (EMEA-000877-PIP03-17-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T10:51:00Z","last_updated_date":"2023-10-12T10:51:00Z","reference_number":"EMA/808271/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0438-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-bupivacaine-exparel-liposomal-emea-000877-pip03-17-m04_en.pdf"},
    {"id":"60375","name":"P/0439/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz) (EMEA-000576-PIP03-12-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-12T10:45:00Z","last_updated_date":"2023-10-12T10:45:00Z","reference_number":"EMA/808195/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0439-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-xeljanz-emea-000576-pip03-12-m06_en.pdf"},
    {"id":"60371","name":"P/0428/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M09)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-10-12T10:18:00Z","last_updated_date":"2023-10-12T10:18:00Z","reference_number":"EMA/826798/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0428-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-ambrisentan-volibris-emea-000434-pip01-08-m09_en.pdf"},
    {"id":"60280","name":"P/0457/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for 3,6-diamino-2,5- bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102) (EMEA-001983-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T17:33:00Z","last_updated_date":"2023-10-05T17:33:00Z","reference_number":"EMA/776038/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0457-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-36-diamino-25-bisn-1r-1-carboxy-2-hydroxyethylcarbamoylpyrazine-mb-102-emea-001983-pip01-16-m01_en.pdf"},
    {"id":"60279","name":"P/0456/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for enasidenib (EMEA- 001798-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T17:21:00Z","last_updated_date":"2023-10-05T17:21:00Z","reference_number":"EMA/775977/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0456-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-enasidenib-emea-001798-pip02-16-m01_en.pdf"},
    {"id":"60278","name":"P/0455/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for atidarsagene autotemcel (Libmeldy), (EMEA-001765-PIP02-15-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T17:14:00Z","last_updated_date":"2023-10-05T17:14:00Z","reference_number":"EMA/775900/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0455-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-atidarsagene-autotemcel-libmeldy-emea-001765-pip02-15-m04_en.pdf"},
    {"id":"60277","name":"P/0434/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (Kerendia) (EMEA-001623-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T17:04:00Z","last_updated_date":"2023-10-05T17:04:00Z","reference_number":"EMA/808511/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0434-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-finerenone-kerendia-emea-001623-pip01-14-m05_en.pdf"},
    {"id":"60276","name":"P/0435/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya) (EMEA-001523-PIP03-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T16:58:00Z","last_updated_date":"2023-10-05T16:58:00Z","reference_number":"EMA/808374/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0435-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-guselkumab-tremfya-emea-001523-pip03-18-m02_en.pdf"},
    {"id":"60275","name":"P/0436/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP03-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T16:48:00Z","last_updated_date":"2023-10-05T16:48:00Z","reference_number":"EMA/638309/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0436-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-maralixibat-chloride-emea-001475-pip03-17-m03_en.pdf"},
    {"id":"60274","name":"P/0437/2022: EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for outer membrane vesicles (OMV) from N. meningitidis Strain NZ 98/254..(EMEA-001260-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T16:38:00Z","last_updated_date":"2023-10-05T16:38:00Z","reference_number":"EMA/808316/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0437-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-outer-membrane-vesicles-omv-n-meningitidis-strain-nz-98-254emea-001260-pip01-11-m02_en.pdf"},
    {"id":"60270","name":"P/0427/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan for treprostinil (sodium), (Trisuva and associated names), (EMEA-003182-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T14:57:00Z","last_updated_date":"2023-10-05T14:57:00Z","reference_number":"EMA/825327/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0427-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-treprostinil-sodium-trisuva-associated-names-emea-003182-pip01-22_en.pdf"},
    {"id":"60269","name":"P/0418/2022: EMA decision of 28 October 2022 on the granting of a product specific waiver for pridopidine (hydrochloride) (EMEA-003174-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-05T14:27:00Z","last_updated_date":"2023-10-05T14:27:00Z","reference_number":"EMA/824829/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0418-2022-ema-decision-28-october-2022-granting-product-specific-waiver-pridopidine-hydrochloride-emea-003174-pip02-22_en.pdf"},
    {"id":"60253","name":"P/0452/2022: EMA decision of 28 October 2022 on the granting of a product specific waiver for batoclimab (EMEA-003162-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-04T16:44:00Z","last_updated_date":"2023-10-04T16:44:00Z","reference_number":"EMA/834765/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0452-2022-ema-decision-28-october-2022-granting-product-specific-waiver-batoclimab-emea-003162-pip02-22_en.pdf"},
    {"id":"60252","name":"P/0431/2022: EMA decision of 28 October 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fusion protein composed of the first 2 immunoglobulin (Ig)-like...(EMEA-003157-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-10-04T16:14:00Z","last_updated_date":"2023-10-04T16:14:00Z","reference_number":"EMA/808629/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0431-2022-ema-decision-28-october-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fusion-protein-composed-first-2-immunoglobulin-ig-likeemea-003157-pip01-21_en.pdf"},
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    {"id":"60139","name":"P/0374/2022: EMA decision of 9 September 2022 on the granting of a product specific waiver for xevinapant (EMEA-003235-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T15:53:00Z","last_updated_date":"2023-09-25T15:53:00Z","reference_number":"EMA/705744/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0374-2022-ema-decision-9-september-2022-granting-product-specific-waiver-xevinapant-emea-003235-pip01-22_en.pdf"},
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    {"id":"60135","name":"P/0406/2022: EMA decision of 9 September 2022 on the granting of a product specific waiver for vepsitamab (EMEA-003230-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T14:47:00Z","last_updated_date":"2023-09-25T14:47:00Z","reference_number":"EMA/709251/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0406-2022-ema-decision-9-september-2022-granting-product-specific-waiver-vepsitamab-emea-003230-pip01-22_en.pdf"},
    {"id":"60134","name":"P/0377/2022: EMA decision of 19 September 2022 on the granting of a product specific waiver for telmisartan / amlodipine / hydrochlorothiazide (EMEA- 003229-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-09-25T14:31:00Z","last_updated_date":"2023-09-25T14:31:00Z","reference_number":"EMA/706982/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0377-2022-ema-decision-19-september-2022-granting-product-specific-waiver-telmisartan-amlodipine-hydrochlorothiazide-emea-003229-pip01-22_en.pdf"},
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    {"id":"41547","name":"P/0114/2016: EMA decision of 15 April 2016 on the granting of a product specific waiver for montelukast (sodium) / levocetirizine (dihydrochloride) (EMEA-001908-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/195529/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0114-2016-ema-decision-15-april-2016-granting-product-specific-waiver-montelukast-sodium-levocetirizine-dihydrochloride-emea-001908-pip01-15_en.pdf"},
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    {"id":"59658","name":"P/0341/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eptinezumab (Vyepti) (EMEA-002243-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-29T14:39:00Z","last_updated_date":"2023-08-29T14:39:00Z","reference_number":"EMA/672882/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0341-2022-ema-decision-10-august-2022-acceptance-modification-agreed-paediatric-investigation-plan-eptinezumab-vyepti-emea-002243-pip01-17-m03_en.pdf"},
    {"id":"59656","name":"P/0271/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy... (EMEA-003133-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-29T13:24:00Z","last_updated_date":"2023-08-29T13:24:00Z","reference_number":"EMA/665639/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0271-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-r-tetrahydrofuran-3-yl-4-6-5-4-ethoxy-emea-003133-pip01-21_en.pdf"},
    {"id":"59655","name":"EMA/638357/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for mometasone (furoate) / azelastine (hydrochloride) (EMEA-003122-PIP01-21 )","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-29T12:08:00Z","last_updated_date":"2023-08-29T12:08:00Z","reference_number":"EMA/638357/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-638357-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-waiver-mometasone-furoate-azelastine-hydrochloride-emea-003122-pip01-21_en.pdf"},
    {"id":"59654","name":"P/0358/2022: EMA decision of 22 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zuranolone (EMEA-003119-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-29T11:58:00Z","last_updated_date":"2023-08-29T11:58:00Z","reference_number":"EMA/678051/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0358-2022-ema-decision-22-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-zuranolone-emea-003119-pip01-21_en.pdf"},
    {"id":"59651","name":"P/0340/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for enmetazobactam / cefepime (EMEA-002240-PIP02-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-28T16:01:00Z","last_updated_date":"2023-08-28T16:01:00Z","reference_number":"EMA/672733/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0340-2022-ema-decision-10-august-2022-acceptance-modification-agreed-paediatric-investigation-plan-enmetazobactam-cefepime-emea-002240-pip02-17-m01_en.pdf"},
    {"id":"59650","name":"P/0348/2022 : EMA decision of 10 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for setmelanotide (Imcivree) (EMEA-002209-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-28T15:54:00Z","last_updated_date":"2023-08-28T15:54:00Z","reference_number":"EMA/672726/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0348-2022-ema-decision-10-august-2022-acceptance-modification-agreed-paediatric-investigation-plan-setmelanotide-imcivree-emea-002209-pip01-17-m03_en.pdf"},
    {"id":"59649","name":"P/0336/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lademirsen (EMEA-003064-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-28T13:13:00Z","last_updated_date":"2023-08-28T13:13:00Z","reference_number":"EMA/673785/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0336-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lademirsen-emea-003064-pip01-21_en.pdf"},
    {"id":"59648","name":"P/0346/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for etrasimod L-arginine (EMEA-002713-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-28T12:43:00Z","last_updated_date":"2023-08-28T12:43:00Z","reference_number":"EMA/638356/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0346-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-etrasimod-l-arginine-emea-002713-pip02-21_en.pdf"},
    {"id":"59645","name":"P/0350/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for RSV preF protein (EMEA-003094-PIP02-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-28T11:29:00Z","last_updated_date":"2023-08-28T11:29:00Z","reference_number":"EMA/673786/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0350-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rsv-pref-protein-emea-003094-pip02-21_en.pdf"},
    {"id":"59644","name":"P/0268/2022: EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for gliadin protease (EMEA-003116-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-28T11:14:00Z","last_updated_date":"2023-08-28T11:14:00Z","reference_number":"EMA/662864/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2022-ema-decision-11-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-gliadin-protease-emea-003116-pip01-21_en.pdf"},
    {"id":"59642","name":"P/0345/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for remibrutinib (EMEA-002582-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-28T10:34:00Z","last_updated_date":"2023-08-28T10:34:00Z","reference_number":"EMA/638352/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0345-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-remibrutinib-emea-002582-pip02-21_en.pdf"},
    {"id":"59636","name":"P/0269/2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5Hpyrazolo...(EMEA-003098-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-25T14:55:00Z","last_updated_date":"2023-08-25T14:55:00Z","reference_number":"EMA/662865/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-1r2r-2-4-5-methyl-1h-pyrazol-3-yl-benzoyl-n-4-oxo-67-dihydro-5hpyrazoloemea-003098-pip01-21_en.pdf"},
    {"id":"59641","name":"P/0344/2022 : EMA decision of 10 August 2022 on the granting of a product specific waiver for nipocalimab (EMEA-002559-PIP05-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-28T10:25:00Z","last_updated_date":"2023-08-28T10:25:00Z","reference_number":"EMA/638322/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0344-2022-ema-decision-10-august-2022-granting-product-specific-waiver-nipocalimab-emea-002559-pip05-22_en.pdf"},
    {"id":"59639","name":"P/0274/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2’-O-(2’-methoxyethyl)... (EMEA-003112-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-28T09:43:00Z","last_updated_date":"2023-08-28T09:43:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0274-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2-o-2-methoxyethyl-emea-003112-pip01-21_en.pdf"},
    {"id":"59640","name":"P/0302/2022: EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efruxifermin (EMEA-003114-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-08-28T10:20:00Z","last_updated_date":"2023-08-28T10:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-efruxifermin-emea-003114-pip01-21_en.pdf"},
    {"id":"59626","name":"P/0333/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ritlecitinib (EMEA-002451-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-24T15:45:00Z","last_updated_date":"2023-08-24T15:45:00Z","reference_number":"EMA/673784/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0333-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ritlecitinib-emea-002451-pip02-21_en.pdf"},
    {"id":"59625","name":"P/0286/2022 : EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for deucravacitinib (EMEA-002350-PIP04-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-24T15:39:00Z","last_updated_date":"2023-08-24T15:39:00Z","reference_number":"EMA/629360/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0286-2022-ema-decision-11-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-deucravacitinib-emea-002350-pip04-21_en.pdf"},
    {"id":"59624","name":"P/0355/2022 : EMA decision of 12 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tezepelumab (EMEA-001613-PIP04-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-24T15:31:00Z","last_updated_date":"2023-08-24T15:31:00Z","reference_number":"EMA/676814/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0355-2022-ema-decision-12-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tezepelumab-emea-001613-pip04-21_en.pdf"},
    {"id":"59623","name":"P/0288/2022 : EMA decision of 11 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vibegron (EMEA-001415-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-24T15:27:00Z","last_updated_date":"2023-08-24T15:27:00Z","reference_number":"EMA/629508/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2022-ema-decision-11-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vibegron-emea-001415-pip02-21_en.pdf"},
    {"id":"59622","name":"P/0354/2022 : EMA decision of 10 August 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tocilizumab (RoActemra) (EMEA-000309-PIP09-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-08-24T15:16:00Z","last_updated_date":"2023-08-24T15:16:00Z","reference_number":"EMA/676104/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0354-2022-ema-decision-10-august-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tocilizumab-roactemra-emea-000309-pip09-21_en.pdf"},
    {"id":"58005","name":"P/0259/2022: EMA decision of 15 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for leniolisib phosphate (EMEA-002989-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T15:34:00Z","last_updated_date":"2023-06-29T14:20:00Z","reference_number":"EMA/628925/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2022-ema-decision-15-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-leniolisib-phosphate-emea-002989-pip01-21-m01_en.pdf"},
    {"id":"59145","name":"P/0257/2022: EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for epcoritamab (EMEA-002907-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-29T14:13:00Z","last_updated_date":"2023-06-29T14:13:00Z","reference_number":"EMA/620812/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0257-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-epcoritamab-emea-002907-pip01-20-m01_en.pdf"},
    {"id":"59143","name":"P/0232/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sibeprenlimab (EMEA-003085-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-29T13:56:00Z","last_updated_date":"2023-06-29T13:56:00Z","reference_number":"EMA/575972/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sibeprenlimab-emea-003085-pip01-21_en.pdf"},
    {"id":"59144","name":"P/0250/2022: EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (EMEA-002941-PIP","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-29T14:04:00Z","last_updated_date":"2023-06-29T14:04:00Z","reference_number":"EMA/579371/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-severe-acute-respiratory-syndrome-coronavirus-2-recombinant-spike-protein-nanoparticle-vaccine-matrix_en.pdf"},
    {"id":"59142","name":"P/0206/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for 3,5-diamino-6- chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)... (EMEA-002935-PIP01-20-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T12:25:00Z","last_updated_date":"2023-06-29T12:25:00Z","reference_number":"EMA/275707/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-35-diamino-6-chloro-n-n-4-4-2-hexyl2s3r4r5r-23456-pentahydroxyhexylaminoethoxy-emea-002935-pip01-20_en.pdf"},
    {"id":"59141","name":"P/0256/2022 : EMA decision of 30 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for elasomeran (Spikevax) and elasomeran/imelsomeram (EMEA-002893-PIP01-20-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T12:16:00Z","last_updated_date":"2023-06-29T12:16:00Z","reference_number":"EMA/612853/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2022-ema-decision-30-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-elasomeran-spikevax-elasomeran-imelsomeram-emea-002893-pip01-20-m02_en.pdf"},
    {"id":"59140","name":"P/0221/2022 : EMA decision of 24 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T11:58:00Z","last_updated_date":"2023-06-29T11:58:00Z","reference_number":"EMA/579337/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2022-ema-decision-24-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-remdesivir-veklury-emea-002826-pip01-20-m03_en.pdf"},
    {"id":"59139","name":"P/0219/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, ... (EMEA-002359-PIP01-18-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T11:53:00Z","last_updated_date":"2023-06-29T11:53:00Z","reference_number":"EMA/563099/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigens-equivalent-h1n1-strain-emea-002359-pip01-18-m05_en.pdf"},
    {"id":"59132","name":"P/0190/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for erdafitinib (EMEA-002042-PIP02-20-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T10:13:00Z","last_updated_date":"2023-06-29T10:13:00Z","reference_number":"EMA/251362/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-erdafitinib-emea-002042-pip02-20-m01_en.pdf"},
    {"id":"59135","name":"P/0205/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for zanubrutinib (Brukinsa), (EMEA-002354-PIP02-18-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T11:06:00Z","last_updated_date":"2023-06-29T11:06:00Z","reference_number":"EMA/275723/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-zanubrutinib-brukinsa-emea-002354-pip02-18-m01_en.pdf"},
    {"id":"59130","name":"P/0191/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-002077-PIP01-16-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-29T10:19:00Z","last_updated_date":"2023-06-29T10:19:00Z","reference_number":"EMA/251444/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-ravulizumab-ultomiris-emea-002077-pip01-16-m05_en.pdf"},
    {"id":"59108","name":"P/062/2022 : EMA decision of 18 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilzabrutinib (EMEA- 002438-PIP02-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T10:31:00Z","last_updated_date":"2023-06-27T10:31:00Z","reference_number":"EMA/624978/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-062-2022-ema-decision-18-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-rilzabrutinib-emea-002438-pip02-19-m02_en.pdf"},
    {"id":"59107","name":"P/0249/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for garadacimab (EMEA- 002726-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T10:28:00Z","last_updated_date":"2023-06-27T10:28:00Z","reference_number":"EMA/579333/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0249-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-garadacimab-emea-002726-pip01-19-m02_en.pdf"},
    {"id":"59106","name":"P/0231/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for liposomal ciclosporin A (L-CsA) (EMEA-002344-PIP02-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T10:20:00Z","last_updated_date":"2023-06-27T10:20:00Z","reference_number":"EMA/575636/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-liposomal-ciclosporin-l-csa-emea-002344-pip02-18-m01_en.pdf"},
    {"id":"59105","name":"P/0198/2022 : EMA decision of 2 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP03-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T10:06:00Z","last_updated_date":"2023-06-27T10:06:00Z","reference_number":"EMA/352636/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2022-ema-decision-2-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-rinvoq-emea-001741-pip03-16-m02_en.pdf"},
    {"id":"59104","name":"P/0209/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dopamine (hydrochloride), (EMEA-001105-PIP01-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T10:03:00Z","last_updated_date":"2023-06-27T10:03:00Z","reference_number":"EMA/365809/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-dopamine-hydrochloride-emea-001105-pip01-10-m06_en.pdf"},
    {"id":"59103","name":"P/0208/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T09:52:00Z","last_updated_date":"2023-06-27T09:52:00Z","reference_number":"EMA/365808/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-invokana-emea-001030-pip01-10-m10_en.pdf"},
    {"id":"59102","name":"P/0201/2022 : EMA decision of 21 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T09:48:00Z","last_updated_date":"2023-06-27T09:48:00Z","reference_number":"EMA/266713/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2022-ema-decision-21-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-nemolizumab-emea-001624-pip01-14-m05_en.pdf"},
    {"id":"59101","name":"P/0200/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for loxapine (Adasuve), (EMEA-001115-PIP01-10-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T09:43:00Z","last_updated_date":"2023-06-27T09:43:00Z","reference_number":"EMA/266656/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0200-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-loxapine-adasuve-emea-001115-pip01-10-m08_en.pdf"},
    {"id":"59100","name":"P/0196/2022 : EMA decision of 9 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T09:34:00Z","last_updated_date":"2023-06-27T09:34:00Z","reference_number":"EMA/273998/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2022-ema-decision-9-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m07_en.pdf"},
    {"id":"59099","name":"P/0195/2022: EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for efinaconazole (EMEA- 001627-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-27T09:17:00Z","last_updated_date":"2023-06-27T09:17:00Z","reference_number":"EMA/352509/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-efinaconazole-emea-001627-pip01-14-m02_en.pdf"},
    {"id":"59089","name":"P/0466/2022 : EMA decision of 7 November 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tozinameran, tozinameran / famtozinameran (Comirnaty) (EMEA-002861-PIP02-20-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-26T11:11:00Z","last_updated_date":"2023-06-26T11:11:00Z","reference_number":"EMA/864103/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0466-2022-ema-decision-7-november-2022-acceptance-modification-agreed-paediatric-investigation-plan-tozinameran-tozinameran-famtozinameran-comirnaty-emea-002861-pip02-20-m05_en.pdf"},
    {"id":"58983","name":"P/0199/2022 : EMA decision of 21 June 2022 on the granting of a product specific waiver for flortaucipir F18 (EMEA-003187-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T16:28:00Z","last_updated_date":"2023-06-19T16:28:00Z","reference_number":"EMA/266265/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2022-ema-decision-21-june-2022-granting-product-specific-waiver-flortaucipir-f18-emea-003187-pip01-22_en.pdf"},
    {"id":"58993","name":"P/0203/2022 : EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for methylphenidate (hydrochloride) (EMEA-003189-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T16:39:00Z","last_updated_date":"2023-06-19T16:39:00Z","reference_number":"EMA/275700/2022 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-waiver-methylphenidate-hydrochloride-emea-003189-pip01-22_en.pdf"},
    {"id":"59088","name":"P/0243/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for nirsevimab (EMEA-001784-PIP01-15-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T15:37:00Z","last_updated_date":"2023-06-23T15:37:00Z","reference_number":"EMA/602323/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-nirsevimab-emea-001784-pip01-15-m04_en.pdf"},
    {"id":"59087","name":"P/0263/2022 : EMA decision of 13 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib  (RINVOQ), (EMEA-001741-PIP03-16-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T15:30:00Z","last_updated_date":"2023-06-23T15:30:00Z","reference_number":"EMA/637879/2022 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0263-2022-ema-decision-13-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-rinvoq-emea-001741-pip03-16-m03_en.pdf"},
    {"id":"59086","name":"P/0260/2022 : EMA decision of 15 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for omecamtiv mecarbil (EMEA-001696-PIP01-14-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T15:22:00Z","last_updated_date":"2023-06-23T15:22:00Z","reference_number":"EMA/624973/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2022-ema-decision-15-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-omecamtiv-mecarbil-emea-001696-pip01-14-m02_en.pdf"},
    {"id":"59084","name":"P/0242/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for daprodustat (EMEA-001452-PIP01-13-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T15:02:00Z","last_updated_date":"2023-06-23T15:02:00Z","reference_number":"EMA/602322/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-daprodustat-emea-001452-pip01-13-m04_en.pdf"},
    {"id":"59083","name":"P/0237/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ixazomib (Ninlaro), (EMEA-001410-PIP02-17-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T14:53:00Z","last_updated_date":"2023-06-23T14:53:00Z","reference_number":"EMA/602320/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0237-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-ixazomib-ninlaro-emea-001410-pip02-17-m04_en.pdf"},
    {"id":"59080","name":"P/0236/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Tenkasi), (EMEA-001270-PIP01-12-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T14:31:00Z","last_updated_date":"2023-06-23T14:31:00Z","reference_number":"EMA/602319/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-oritavancin-diphosphate-tenkasi-emea-001270-pip01-12-m05_en.pdf"},
    {"id":"59079","name":"P/0226/2022 : EMA decision of 8 July 2022on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate) / mometasone (furoate) (Atectura Breezhaler and its duplicate authorization ...), (EMEA-001217-PIP01-11-M08)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T14:02:00Z","last_updated_date":"2023-06-23T14:02:00Z","reference_number":"EMA/575722/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2022-ema-decision-8-july-2022on-acceptance-modification-agreed-paediatric-investigation-plan-indacaterol-acetate-mometasone-furoate-atectura-breezhaler-its-duplicate-authorization-emea-001217_en.pdf"},
    {"id":"59078","name":"P/0264/2022 : EMA decision of 13 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for modified vaccinia  ankara - bavarian nordic virus (smallpox), (EMEA-001161-PIP02-11-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T13:52:00Z","last_updated_date":"2023-06-23T13:54:00Z","reference_number":"EMA/639617/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0264-2022-ema-decision-13-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-modified-vaccinia-ankara-bavarian-nordic-virus-smallpox-emea-001161-pip02-11-m01_en.pdf"},
    {"id":"59077","name":"P/0245/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for hepatitis B (rDNA) surface antigen adjuvanted (HEPLISAV B), (EMEA-001127-PIP02-11-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-23T13:02:00Z","last_updated_date":"2023-06-23T13:02:00Z","reference_number":"EMA/595941/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-hepatitis-b-rdna-surface-antigen-adjuvanted-heplisav-b-emea-001127-pip02-11-m02_en.pdf"},
    {"id":"59042","name":"P/0239/2022: EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) (Apexxnar), (EMEA-002330-PIP01-18-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T14:40:00Z","last_updated_date":"2023-06-22T14:40:00Z","reference_number":"EMA/602333/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-pneumococcal-polysaccharide-conjugate-vaccine-20-valent-adsorbed-apexxnar-emea-002330-pip01-18-m02_en.pdf"},
    {"id":"59032","name":"P/0244/2022: EMA decision of 8 July on the acceptance of a modification of an agreed paediatric investigation plan for vadadustat (EMEA-001944-PIP01-16-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T11:11:00Z","last_updated_date":"2023-06-22T11:11:00Z","reference_number":"EMA/602327/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0244-2022-ema-decision-8-july-acceptance-modification-agreed-paediatric-investigation-plan-vadadustat-emea-001944-pip01-16-m04_en.pdf"},
    {"id":"59038","name":"P/0238/2022: EMA decision of8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for daratumumab (Darzalex), (EMEA-002152-PIP01-17-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T13:44:00Z","last_updated_date":"2023-06-22T13:44:00Z","reference_number":"EMA/602331/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0238-2022-ema-decision-of8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-daratumumab-darzalex-emea-002152-pip01-17-m03_en.pdf"},
    {"id":"59040","name":"P/0265/2022: EMA decision of 22 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for elexacaftor / tezacaftor/ ivacaftor (Kaftrio), (EMEA-002324-PIP01-17-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-22T14:10:00Z","last_updated_date":"2023-06-22T14:10:00Z","reference_number":"EMA/624974/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2022-ema-decision-22-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-elexacaftor-tezacaftor-ivacaftor-kaftrio-emea-002324-pip01-17-m03_en.pdf"},
    {"id":"59025","name":"P/0223/2022: EMA decision of 8 July 2022 on the granting of a product specific waiver for botulinum toxin type E (EMEA-003190-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T16:43:00Z","last_updated_date":"2023-06-21T16:43:00Z","reference_number":"EMA/609038/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2022-ema-decision-8-july-2022-granting-product-specific-waiver-botulinum-toxin-type-e-emea-003190-pip01-22_en.pdf"},
    {"id":"59024","name":"P/0227/2022: EMA decision of 8 July 2022 on the granting of a product specific waiver for peptide KLBPVQLWV / peptide SMPPPGTRV / peptide YLQLVFGIEV / peptide RLLQETELV / peptide YLSGADLNL / peptide LLTFWNPPV / peptide IMIGHLVGV / peptide KVAEIVHFL / pept","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T16:36:00Z","last_updated_date":"2023-06-21T16:36:00Z","reference_number":"EMA/575399/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2022-ema-decision-8-july-2022-granting-product-specific-waiver-peptide-klbpvqlwv-peptide-smpppgtrv-peptide-ylqlvfgiev-peptide-rllqetelv-peptide-ylsgadlnl-peptide-lltfwnppv-peptide-imighlvgv_en.pdf"},
    {"id":"59023","name":"P/0261/2022: EMA decision of 15 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant COVID-19 subunit nanoparticle (adjuvanted with AS03) (GBP510) (EMEA-003115-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T16:29:00Z","last_updated_date":"2023-06-21T16:29:00Z","reference_number":"EMA/629584/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0261-2022-ema-decision-15-july-2022-agreement-paediatric-investigation-plan-granting-deferral-recombinant-covid-19-subunit-nanoparticle-adjuvanted-as03-gbp510-emea-003115-pip01-21_en.pdf"},
    {"id":"59022","name":"P/0232/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sibeprenlimab (EMEA-003085-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T16:19:00Z","last_updated_date":"2023-06-21T16:19:00Z","reference_number":"EMA/575972/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sibeprenlimab-emea-003085-pip01-21_en.pdf-0"},
    {"id":"59021","name":"P/0218/2022 : EMA decision of 8 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cannabidiol (Epidyolex), (EMEA-001964-PIP01-16-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T16:17:00Z","last_updated_date":"2023-06-21T16:17:00Z","reference_number":"EMA/562057/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2022-ema-decision-8-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-cannabidiol-epidyolex-emea-001964-pip01-16-m04_en.pdf"},
    {"id":"59020","name":"P/0189/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP02-20-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T16:07:00Z","last_updated_date":"2023-06-21T16:07:00Z","reference_number":"EMA/251270/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-ravulizumab-ultomiris-emea-001943-pip02-20-m01_en.pdf"},
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    {"id":"59018","name":"P/0188/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP01-16-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T15:53:00Z","last_updated_date":"2023-06-21T15:53:00Z","reference_number":"EMA/251237/2022 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-ravulizumab-ultomiris-emea-001943-pip01-16-m07_en.pdf"},
    {"id":"59017","name":"P/0222/2022 : EMA decision of 24 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid ... (EMEA-001930-PIP01-16-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T15:38:00Z","last_updated_date":"2023-06-21T15:38:00Z","reference_number":"EMA/595648/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2022-ema-decision-24-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-neisseria-meningitidis-serogroup-polysaccharide-conjugated-tetanus-toxoid-emea-001930-pip01-16-m04_en.pdf"},
    {"id":"59016","name":"P/0194/2022: EMA decision of 10 June 2022 on the granting of a product specific waiver for sugemalimab (EMEA-003179-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T15:30:00Z","last_updated_date":"2023-06-21T15:30:00Z","reference_number":"EMA/251179/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2022-ema-decision-10-june-2022-granting-product-specific-waiver-sugemalimab-emea-003179-pip01-22_en.pdf"},
    {"id":"59009","name":"P/0214/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lanadelumab (Takhzyro), (EMEA-001864-PIP01-15-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T15:24:00Z","last_updated_date":"2023-06-21T15:24:00Z","reference_number":"EMA/366000/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-lanadelumab-takhzyro-emea-001864-pip01-15-m07_en.pdf"},
    {"id":"59014","name":"P/0207/2022: EMA decision of 10 June 2022 on the granting of a product specific waiver for anti-TGFbeta fully human monoclonal antibody (NIS793) (EMEA-003178-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T15:18:00Z","last_updated_date":"2023-06-21T15:18:00Z","reference_number":"EMA/275703/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2022-ema-decision-10-june-2022-granting-product-specific-waiver-anti-tgfbeta-fully-human-monoclonal-antibody-nis793-emea-003178-pip01-21_en.pdf"},
    {"id":"59012","name":"P/0217/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cedazuridine / decitabine (EMEA-003071-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-21T14:50:00Z","last_updated_date":"2023-06-21T14:50:00Z","reference_number":"EMA/366238/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cedazuridine-decitabine-emea-003071-pip01-21_en.pdf"},
    {"id":"59011","name":"P/0213/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for inebilizumab (EMEA-001911-PIP01-15-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T14:18:00Z","last_updated_date":"2023-06-21T14:18:00Z","reference_number":"EMA/365879/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-inebilizumab-emea-001911-pip01-15-m04_en.pdf"},
    {"id":"59001","name":"P/0228/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of 2 synthetic double-stranded N-Acetyl-galactosamine conjugated siRNA oligonucleoti","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-20T11:44:00Z","last_updated_date":"2023-06-20T11:44:00Z","reference_number":"EMA/609177/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0228-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mixture-2-synthetic-double-stranded-n-acetyl-galactosamine-conjugated-sirna-oligonucleoti_en.pdf"},
    {"id":"59000","name":"P/0246/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lonafarnib (EMEA-002516-PIP02-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-20T11:33:00Z","last_updated_date":"2023-06-20T11:33:00Z","reference_number":"EMA/595664/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lonafarnib-emea-002516-pip02-21_en.pdf"},
    {"id":"58990","name":"P/0235/2022: EMA decision of 8 July 2022 on the granting of a product specific waiver for trabectedin (Yondelis), (EMEA-000610-PIP02-22) in accordance with Regulation (EC) No 1901/2006","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T15:26:00Z","last_updated_date":"2023-06-19T15:26:00Z","reference_number":"EMA/602315/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2022-ema-decision-8-july-2022-granting-product-specific-waiver-trabectedin-yondelis-emea-000610-pip02-22-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"58991","name":"P/0225/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benralizumab (Fasenra), (EMEA-001214-PIP09-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T16:08:00Z","last_updated_date":"2023-06-19T16:08:00Z","reference_number":"EMA/609126/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-benralizumab-fasenra-emea-001214-pip09-21_en.pdf"},
    {"id":"58988","name":"P/0234/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for cannabidiol  (Epidyolex), (EMEA-001964-PIP03-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T14:23:00Z","last_updated_date":"2023-06-19T14:23:00Z","reference_number":"EMA/575947/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-waiver-cannabidiol-epidyolex-emea-001964-pip03-21_en.pdf"},
    {"id":"59003","name":"P/0240/2022: EMA decision of 8 July 2022 on the granting of a product specific waiver for parsaclisib (hydrochloride) (EMEA-002696-PIP03-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-20T12:02:00Z","last_updated_date":"2023-06-20T12:02:00Z","reference_number":"EMA/602335/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0240-2022-ema-decision-8-july-2022-granting-product-specific-waiver-parsaclisib-hydrochloride-emea-002696-pip03-22_en.pdf"},
    {"id":"58998","name":"P/0233/2022 : EMA decision of 8 July 2022 on the granting of a product specific waiver for botulinum toxin type A (EMEA-003202-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T17:57:00Z","last_updated_date":"2023-06-19T17:57:00Z","reference_number":"EMA/575495/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2022-ema-decision-8-july-2022-granting-product-specific-waiver-botulinum-toxin-type-emea-003202-pip01-22_en.pdf"},
    {"id":"58997","name":"P/0252/2022 : EMA decision of 8 July 2022 on the granting of a product specific waiver for 224Radium adsorbed in calcium carbonate microparticles (EMEA-003199-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T17:49:00Z","last_updated_date":"2023-06-19T17:49:00Z","reference_number":"EMA/579377/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2022-ema-decision-8-july-2022-granting-product-specific-waiver-224radium-adsorbed-calcium-carbonate-microparticles-emea-003199-pip01-22_en.pdf"},
    {"id":"58996","name":"P/0224/2022 : EMA decision of 8 July 2022 on the granting of a product specific waiver for autologous bone marrow-derived mononuclear cell  enriched white blood cells (EMEA-003193-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T17:20:00Z","last_updated_date":"2023-06-19T17:20:00Z","reference_number":"EMA/609069/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2022-ema-decision-8-july-2022-granting-product-specific-waiver-autologous-bone-marrow-derived-mononuclear-cell-enriched-white-blood-cells-emea-003193-pip01-22_en.pdf"},
    {"id":"58982","name":"P/0210/2022 : EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for reparixin (EMEA-001693-PIP03-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-19T16:25:00Z","last_updated_date":"2023-06-19T16:25:00Z","reference_number":"EMA/365815/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-deferral-reparixin-emea-001693-pip03-21_en.pdf"},
    {"id":"58992","name":"P/0202/2022 : EMA decision of 10 June 2022 on the refusal of a paediatric investigation plan and on the granting of a waiver for clonidine (EMEA-003198-PIP01-22)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-06-21T16:07:00Z","last_updated_date":"2023-06-21T16:07:00Z","reference_number":"EMA/266803/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0202-2022-ema-decision-10-june-2022-refusal-paediatric-investigation-plan-granting-waiver-clonidine-emea-003198-pip01-22_en.pdf"},
    {"id":"58936","name":"P/254/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bepirovirsen (EMEA-003082-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T11:50:00Z","last_updated_date":"2023-06-13T11:50:00Z","reference_number":"EMA/579397/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-254-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bepirovirsen-emea-003082-pip01-21_en.pdf"},
    {"id":"58935","name":"P/253/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous tumour-infiltrating lymphocytes (TILs) (EMEA-003072-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T11:38:00Z","last_updated_date":"2023-06-13T11:38:00Z","reference_number":"EMA/579392/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-253-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-tumour-infiltrating-lymphocytes-tils-emea-003072-pip01-21_en.pdf"},
    {"id":"58934","name":"P/241/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cagrilintide / semaglutide (EMEA-003059-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T11:32:00Z","last_updated_date":"2023-06-13T11:32:00Z","reference_number":"EMA/602351/2022 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-241-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cagrilintide-semaglutide-emea-003059-pip01-21_en.pdf"},
    {"id":"58932","name":"P/229/2022 : EMA decision of 8 July 2022 on the granting of a product specific waiver for lurbinectedin (EMEA-002846-PIP02-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T11:21:00Z","last_updated_date":"2023-06-13T11:21:00Z","reference_number":"EMA/575429/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-229-2022-ema-decision-8-july-2022-granting-product-specific-waiver-lurbinectedin-emea-002846-pip02-22_en.pdf"},
    {"id":"58931","name":"P/255/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for respiratory syncytial virus stabilised prefusion F subunit vaccine (EMEA- 002795-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T11:16:00Z","last_updated_date":"2023-06-13T11:16:00Z","reference_number":"EMA/576006/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-255-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-respiratory-syncytial-virus-stabilised-prefusion-f-subunit-vaccine-emea-002795-pip02-21_en.pdf"},
    {"id":"58930","name":"P/251/2022 : EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for autologous CD3+CD4+CD25+CD127-FoxP3+ polyclonal regulatory T cells ex vivo expanded (EMEA-002737- PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T11:05:00Z","last_updated_date":"2023-06-13T11:05:00Z","reference_number":"EMA/579390/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-251-2022-ema-decision-8-july-2022-agreement-paediatric-investigation-plan-granting-waiver-autologous-cd3cd4cd25cd127-foxp3-polyclonal-regulatory-t-cells-ex-vivo-expanded-emea-002737-pip01-19_en.pdf"},
    {"id":"58927","name":"P/211/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for whole-cell heat-inactivated bacterial strains (EMEA-003026-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T09:55:00Z","last_updated_date":"2023-06-13T09:55:00Z","reference_number":"EMA/365816/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-211-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-whole-cell-heat-inactivated-bacterial-strains-emea-003026-pip02-21_en.pdf"},
    {"id":"58926","name":"P/197/2022: EMA decision of 9 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for apraglutide (EMEA-003016-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T09:41:00Z","last_updated_date":"2023-06-13T09:41:00Z","reference_number":"EMA/352542/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-197-2022-ema-decision-9-june-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-apraglutide-emea-003016-pip01-21_en.pdf"},
    {"id":"58925","name":"P/193/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for recombinant adeno-associated viral (rAAV) vector expressing the human ornithine transcarbamylase (hOTC) gene (EMEA-002983-PIP0","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T09:35:00Z","last_updated_date":"2023-06-13T09:35:00Z","reference_number":"EMA/251505/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-193-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-waiver-recombinant-adeno-associated-viral-raav-vector-expressing-human-ornithine-transcarbamylase-hotc-gene-emea_en.pdf"},
    {"id":"58924","name":"P/192/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for sirolimus (EMEA-002982-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T09:25:00Z","last_updated_date":"2023-06-13T09:25:00Z","reference_number":"EMA/251491/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-192-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-waiver-sirolimus-emea-002982-pip01-21_en.pdf"},
    {"id":"58923","name":"P/0216/2022: EMA decision of 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dersimelagon (EMEA-002850-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-13T09:15:00Z","last_updated_date":"2023-06-13T09:15:00Z","reference_number":"EMA/366139/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dersimelagon-emea-002850-pip02-21_en.pdf"},
    {"id":"58920","name":"P/0204/2022 : EMA decision on 10 June 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for omaveloxolone (EMEA-002487-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-12T13:40:00Z","last_updated_date":"2023-06-12T13:40:00Z","reference_number":"EMA/275720/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2022-ema-decision-10-june-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-omaveloxolone-emea-002487-pip01-18_en.pdf"},
    {"id":"58643","name":"P/0147/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for odevixibat (Bylvay), (EMEA-002054-PIP01-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T10:03:00Z","last_updated_date":"2023-05-12T10:03:00Z","reference_number":"EMA/206556/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-odevixibat-bylvay-emea-002054-pip01-16-m03_en.pdf"},
    {"id":"58645","name":"P/0149/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride (KH176) (EMEA-002113-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T10:03:00Z","last_updated_date":"2023-05-12T10:03:00Z","reference_number":"EMA/206268/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-s-6-hydroxy-2578-tetramethyl-n-r-piperidin-3-ylchroman-2-carboxamide-hydrochloride-kh176-emea-002113_en.pdf"},
    {"id":"58644","name":"P/0148/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for venetoclax (Venclyxto), (EMEA-002018-PIP02-16-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T10:03:00Z","last_updated_date":"2023-05-12T10:03:00Z","reference_number":"EMA/206375/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-venetoclax-venclyxto-emea-002018-pip02-16-m05_en.pdf"},
    {"id":"58721","name":"P/0187/2022 : EMA decision on 25 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-17T11:46:00Z","last_updated_date":"2023-05-17T11:46:00Z","reference_number":"EMA/274001/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2022-ema-decision-25-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip03-15-m05_en.pdf"},
    {"id":"58720","name":"P/0185/2022 : EMA decision on 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for avibactam / aztreonam (EMEA-002283-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-17T11:46:00Z","last_updated_date":"2023-05-17T11:46:00Z","reference_number":"EMA/640003/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-avibactam-aztreonam-emea-002283-pip01-17-m03_en.pdf"},
    {"id":"58719","name":"P/0180/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brincidofovir (EMEA- 001904-PIP03-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-17T11:27:00Z","last_updated_date":"2023-05-17T11:27:00Z","reference_number":"EMA/205675/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-brincidofovir-emea-001904-pip03-18-m02_en.pdf"},
    {"id":"58717","name":"P/0179/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-17T11:16:00Z","last_updated_date":"2023-05-17T11:16:00Z","reference_number":"EMA/205775/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-cemiplimab-libtayo-emea-002007-pip02-17-m02_en.pdf"},
    {"id":"58716","name":"P/0177/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-17T11:10:00Z","last_updated_date":"2023-05-17T11:10:00Z","reference_number":"EMA/205591/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-sufentanil-citrate-ketamine-hydrochloride-emea-001739-pip02-16-m01_en.pdf"},
    {"id":"58713","name":"P/0175/2022 : EMA decision of 13 May 2022 on the refusal of a modification of an agreed paediatric investigation plan for betibeglogene autotemcel (Zynteglo), (EMEA-001665-PIP01-14-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T17:15:00Z","last_updated_date":"2023-05-16T17:15:00Z","reference_number":"EMA/206734/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2022-ema-decision-13-may-2022-refusal-modification-agreed-paediatric-investigation-plan-betibeglogene-autotemcel-zynteglo-emea-001665-pip01-14-m06_en.pdf"},
    {"id":"58712","name":"P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T17:15:00Z","last_updated_date":"2023-05-16T17:15:00Z","reference_number":"EMA/207913/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-tirzepatide-emea-002360-pip01-18-m02_en.pdf"},
    {"id":"58710","name":"P/0170/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remibrutinib (EMEA-002582-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T16:19:00Z","last_updated_date":"2023-05-16T16:19:00Z","reference_number":"EMA/204227/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0170-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-remibrutinib-emea-002582-pip01-19-m01_en.pdf"},
    {"id":"58709","name":"P/0168/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for human, recombinant, non-fucosylated IgG1k monoclonal antibody...(EMEA-002886-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T16:19:00Z","last_updated_date":"2023-05-16T16:19:00Z","reference_number":"EMA/204358/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-human-recombinant-non-fucosylated-igg1k-monoclonal-antibodyemea-002886-pip01-20-m01_en.pdf"},
    {"id":"58706","name":"P/0163/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T15:51:00Z","last_updated_date":"2023-05-16T15:51:00Z","reference_number":"EMA/207939/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-cefiderocol-fetcroja-emea-002133-pip01-17-m02_en.pdf"},
    {"id":"58707","name":"P/0164/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bis-choline tetrathiomolybdate (EMEA-002232-PIP02-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-16T15:51:00Z","last_updated_date":"2023-05-16T15:51:00Z","reference_number":"EMA/207916/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-bis-choline-tetrathiomolybdate-emea-002232-pip02-19-m02_en.pdf"},
    {"id":"58680","name":"P/0166/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for regdanvimab (Regkirona), (EMEA-002961-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T17:57:00Z","last_updated_date":"2023-05-12T17:57:00Z","reference_number":"EMA/204850/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-regdanvimab-regkirona-emea-002961-pip01-21-m01_en.pdf"},
    {"id":"58679","name":"P/0161/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T17:15:00Z","last_updated_date":"2023-05-12T17:15:00Z","reference_number":"EMA/169194/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip02-14-m03_en.pdf"},
    {"id":"58678","name":"P/0160/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine acetate (Zebinix), (EMEA-000696-PIP02-10-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T17:15:00Z","last_updated_date":"2023-05-12T17:15:00Z","reference_number":"EMA/169198/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-eslicarbazepine-acetate-zebinix-emea-000696-pip02-10-m08_en.pdf"},
    {"id":"58677","name":"P/0159/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for magnesium sulphate heptahydrate / potassium sulphate / sodium sulphate anhydrous... (EMEA-000816-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T17:15:00Z","last_updated_date":"2023-05-12T17:15:00Z","reference_number":"EMA/169200/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-magnesium-sulphate-heptahydrate-potassium-sulphate-sodium-sulphate-anhydrous-emea-000816-pip02-10-m03_en.pdf"},
    {"id":"58648","name":"P/0157/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T10:57:00Z","last_updated_date":"2023-05-12T10:57:00Z","reference_number":"EMA/206659/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m09_en.pdf"},
    {"id":"58647","name":"P/0155/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (Reblozyl), (EMEA-001521-PIP01-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T10:57:00Z","last_updated_date":"2023-05-12T10:57:00Z","reference_number":"EMA/206730/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-luspatercept-reblozyl-emea-001521-pip01-13-m06_en.pdf"},
    {"id":"58646","name":"P/0154/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (Lenvima, Kisplyx), (EMEA-001119-PIP03-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-12T10:57:00Z","last_updated_date":"2023-05-12T10:57:00Z","reference_number":"EMA/206618/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2022-ema-decision-13-may-2022-acceptance-modification-agreed-paediatric-investigation-plan-lenvatinib-lenvima-kisplyx-emea-001119-pip03-19-m02_en.pdf"},
    {"id":"58171","name":"P/0540/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA-002360-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-27T16:16:00Z","last_updated_date":"2023-03-27T16:16:00Z","reference_number":"EMA/699404/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0540-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-tirzepatide-emea-002360-pip01-18-m01_en.pdf"},
    {"id":"58199","name":"P/0491/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for soticlestat (EMEA-002572-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-29T12:46:00Z","last_updated_date":"2023-03-29T12:46:00Z","reference_number":"EMA/626884/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0491-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-soticlestat-emea-002572-pip02-19-m01_en.pdf"},
    {"id":"58615","name":"P/0153/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for human IgG4-based bispecific antibody binding to both B-cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3) (REGN5458) (EMEA-003175-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-10T15:57:00Z","last_updated_date":"2023-05-10T15:57:00Z","reference_number":"EMA/205812/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2022-ema-decision-13-may-2022-granting-product-specific-waiver-human-igg4-based-bispecific-antibody-binding-both-b-cell-maturation-antigen-bcma-cluster-differentiation-3-cd3-regn5458-emea_en.pdf"},
    {"id":"58626","name":"P/0181/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for sacituzumab govitecan (Trodelvy), (EMEA-002645-PIP03-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T11:48:00Z","last_updated_date":"2023-05-11T11:48:00Z","reference_number":"EMA/205815/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2022-ema-decision-13-may-2022-granting-product-specific-waiver-sacituzumab-govitecan-trodelvy-emea-002645-pip03-21_en.pdf"},
    {"id":"58630","name":"P/0186/2022 : EMA decision of 16 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised KLB/FGFR1c monoclonal antibody (MK-3655) (EMEA-003058-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T12:05:00Z","last_updated_date":"2023-05-11T12:05:00Z","reference_number":"EMA/258327/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2022-ema-decision-16-may-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-humanised-klb-fgfr1c-monoclonal-antibody-mk-3655-emea-003058-pip01-21_en.pdf"},
    {"id":"58640","name":"P/0178/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for dupilumab (Dupixent), (EMEA-001501-PIP11-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T17:07:00Z","last_updated_date":"2023-05-11T17:07:00Z","reference_number":"EMA/205791/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2022-ema-decision-13-may-2022-granting-product-specific-waiver-dupilumab-dupixent-emea-001501-pip11-21_en.pdf"},
    {"id":"58639","name":"P/0176/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for zandelisib (EMEA-003158-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T17:07:00Z","last_updated_date":"2023-05-11T17:07:00Z","reference_number":"EMA/205830/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2022-ema-decision-13-may-2022-granting-product-specific-waiver-zandelisib-emea-003158-pip01-21_en.pdf"},
    {"id":"58638","name":"P/0169/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for infigratinib (EMEA-002594-PIP03-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T16:09:00Z","last_updated_date":"2023-05-11T16:09:00Z","reference_number":"EMA/204326/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2022-ema-decision-13-may-2022-granting-product-specific-waiver-infigratinib-emea-002594-pip03-21_en.pdf"},
    {"id":"58637","name":"P/0167/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for anti-CD40L humanised monoclonal antibody (SAR441344) (EMEA-002945-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T16:09:00Z","last_updated_date":"2023-05-11T16:09:00Z","reference_number":"EMA/204558/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2022-ema-decision-13-may-2022-granting-product-specific-waiver-anti-cd40l-humanised-monoclonal-antibody-sar441344-emea-002945-pip02-21_en.pdf"},
    {"id":"58636","name":"P/0165/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for izaflortaucipir (18F) (EMEA-003040-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T15:42:00Z","last_updated_date":"2023-05-11T15:42:00Z","reference_number":"EMA/204931/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2022-ema-decision-13-may-2022-granting-product-specific-waiver-izaflortaucipir-18f-emea-003040-pip02-21_en.pdf"},
    {"id":"58635","name":"P/0162/2022 : EMA decision of 13 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for virus-like particle of SARS-CoV-2 spike protein (recombinant, adjuvant) (CoVLP) (EMEA-003008-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T15:42:00Z","last_updated_date":"2023-05-11T15:42:00Z","reference_number":"EMA/207850/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2022-ema-decision-13-may-2022-agreement-paediatric-investigation-plan-granting-deferral-virus-particle-sars-cov-2-spike-protein-recombinant-adjuvant-covlp-emea-003008-pip01-21_en.pdf"},
    {"id":"58632","name":"P/0158/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for (2S) 4 [2 methoxyethyl [4 (5,6,7,8 tetrahydro 1,8 naphthyridin 2 yl)butyl] amino] 2 (quinazolin 4 ylamino)butanoic acid (EMEA-003159-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T12:38:00Z","last_updated_date":"2023-05-11T12:38:00Z","reference_number":"EMA/169216/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2022-ema-decision-13-may-2022-granting-product-specific-waiver-2s-4-2-methoxyethyl-4-5678-tetrahydro-18-naphthyridin-2-ylbutyl-amino-2-quinazolin-4-ylaminobutanoic-acid-emea-003159-pip01-21_en.pdf"},
    {"id":"58631","name":"P/0156/2022 : EMA decision of 13 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for deucravacitinib (EMEA-002350-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T12:38:00Z","last_updated_date":"2023-05-11T12:38:00Z","reference_number":"EMA/205934/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2022-ema-decision-13-may-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-deucravacitinib-emea-002350-pip02-20_en.pdf"},
    {"id":"58628","name":"P/0183/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for 3,4-dimethyl-N-(2-phenyl-1H-pyrrolo[2,3-b]pyridin-5- yl)-1H-pyrazole-5-carboxamide (EMEA-003169-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T11:48:00Z","last_updated_date":"2023-05-11T11:48:00Z","reference_number":"EMA/207945/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0183-2022-ema-decision-13-may-2022-granting-product-specific-waiver-34-dimethyl-n-2-phenyl-1h-pyrrolo23-bpyridin-5-yl-1h-pyrazole-5-carboxamide-emea-003169-pip01-21_en.pdf"},
    {"id":"58627","name":"P/0182/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for adeno-associated virus vector serotype 1 containing the human GRN gene (EMEA-003167-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-11T11:48:00Z","last_updated_date":"2023-05-11T11:48:00Z","reference_number":"EMA/207941/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2022-ema-decision-13-may-2022-granting-product-specific-waiver-adeno-associated-virus-vector-serotype-1-containing-human-grn-gene-emea-003167-pip01-21_en.pdf"},
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    {"id":"58619","name":"P/0173/2022 : EMA decision of 13 May 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for peptide derivative of glucagon-like-peptide 1 and... (EMEA-002942-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-05-10T16:54:00Z","last_updated_date":"2023-05-10T16:54:00Z","reference_number":"EMA/204429/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2022-ema-decision-13-may-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-peptide-derivative-glucagon-peptide-1-emea-002942-pip02-20_en.pdf"},
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    {"id":"58477","name":"P/0090/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for tarlatamab (EMEA-003138-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T11:21:00Z","last_updated_date":"2023-04-20T11:21:00Z","reference_number":"EMA/101043/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2022-ema-decision-11-march-2022-granting-product-specific-waiver-tarlatamab-emea-003138-pip01-21_en.pdf"},
    {"id":"58476","name":"P/0059/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for nemtabrutinib (EMEA-003135-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T11:15:00Z","last_updated_date":"2023-04-20T11:15:00Z","reference_number":"EMA/94204/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2022-ema-decision-11-march-2022-granting-product-specific-waiver-nemtabrutinib-emea-003135-pip01-21_en.pdf"},
    {"id":"58475","name":"P/0081/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for nifurtimox (EMEA-003134-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T11:06:00Z","last_updated_date":"2023-04-20T11:06:00Z","reference_number":"EMA/100581/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-waiver-nifurtimox-emea-003134-pip01-21_en.pdf"},
    {"id":"58474","name":"P/0058/2022 : EMA decision of 11 March 2022 on the granting of a product-specific waiver for sunvozertinib (EMEA-003132-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T10:59:00Z","last_updated_date":"2023-04-20T10:59:00Z","reference_number":"EMA/94202/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2022-ema-decision-11-march-2022-granting-product-specific-waiver-sunvozertinib-emea-003132-pip01-21_en.pdf"},
    {"id":"58473","name":"P/0064/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for ceralasertib (EMEA-003127-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T10:49:00Z","last_updated_date":"2023-04-20T10:49:00Z","reference_number":"EMA/67616/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2022-ema-decision-11-march-2022-granting-product-specific-waiver-ceralasertib-emea-003127-pip01-21_en.pdf"},
    {"id":"58472","name":"P/0057/2022 : EMA decision of 11 March 2022 on the granting of a product-specific waiver for avexitide (acetate) (EMEA-003125-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T10:40:00Z","last_updated_date":"2023-04-20T10:40:00Z","reference_number":"EMA/94186/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2022-ema-decision-11-march-2022-granting-product-specific-waiver-avexitide-acetate-emea-003125-pip01-21_en.pdf"},
    {"id":"58471","name":"P/0094/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for human normal immunoglobulin (Flebogamma 5% DIF) (EMEA-003121-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T10:29:00Z","last_updated_date":"2023-04-20T10:29:00Z","reference_number":"EMA/105652/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2022-ema-decision-11-march-2022-granting-product-specific-waiver-human-normal-immunoglobulin-flebogamma-5-dif-emea-003121-pip01-21_en.pdf"},
    {"id":"58470","name":"P/0063/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for dapagliflozin / 2-{(3S)-7-fluoro-4-[(3-oxo-3,4-dihydro- 2H-1,4-benzoxazin-6-yl)carbonyl]-3,4-dihydro- 2H-1,4-benzoxazin-3-yl}.....(AZD9977) (EMEA-003120-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-20T10:20:00Z","last_updated_date":"2023-04-20T10:20:00Z","reference_number":"EMA/67591/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2022-ema-decision-11-march-2022-granting-product-specific-waiver-dapagliflozin-2-3s-7-fluoro-4-3-oxo-34-dihydro-2h-14-benzoxazin-6-ylcarbonyl-34-dihydro-2h-14-benzoxazin-3-ylazd9977-emea-003120_en.pdf"},
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    {"id":"58463","name":"P/0068/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for glutamine (EMEA- 001996-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T16:41:00Z","last_updated_date":"2023-04-19T16:41:00Z","reference_number":"EMA/68911/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2022-ema-decision-11-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-glutamine-emea-001996-pip02-16-m01_en.pdf"},
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    {"id":"58446","name":"P/0066/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ex vivo expanded autologous human corneal epithelium cells containing stem cells (Holoclar), (EMEA-001082-PIP02-11- M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T15:04:00Z","last_updated_date":"2023-04-19T15:04:00Z","reference_number":"EMA/68410/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2022-ema-decision-11-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-ex-vivo-expanded-autologous-human-corneal-epithelium-cells-containing-stem-cells-holoclar-emea_en.pdf"},
    {"id":"58445","name":"P/0075/2022 : EMA decision of 11 March 2022 on the refusal of a modification of an agreed paediatric investigation plan for modified allergen extract of birch pollen (EMEA-000932-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:35:00Z","last_updated_date":"2023-04-19T14:35:00Z","reference_number":"EMA/65170/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2022-ema-decision-11-march-2022-refusal-modification-agreed-paediatric-investigation-plan-modified-allergen-extract-birch-pollen-emea-000932-pip01-10-m02_en.pdf"},
    {"id":"58444","name":"P/0074/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris), (EMEA-000876-PIP05-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:22:00Z","last_updated_date":"2023-04-19T14:22:00Z","reference_number":"EMA/65171/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2022-ema-decision-11-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-eculizumab-soliris-emea-000876-pip05-15-m05_en.pdf"},
    {"id":"58443","name":"P/0123/2022 - EMA decision of 15 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tapotoclax (EMEA- 002631-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:22:00Z","last_updated_date":"2023-04-19T14:22:00Z","reference_number":"EMA/149058/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2022-ema-decision-15-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-tapotoclax-emea-002631-pip01-19-m01_en.pdf"},
    {"id":"58442","name":"P/0121/2022 : EMA decision of 15 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ofatumumab (Kesimpta), (EMEA-002397-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:16:00Z","last_updated_date":"2023-04-19T14:16:00Z","reference_number":"EMA/149052/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2022-ema-decision-15-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-ofatumumab-kesimpta-emea-002397-pip01-18-m02_en.pdf"},
    {"id":"58441","name":"P/0097/2022 : EMA decision of 17 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lisdexamfetamine (dimesylate), (Elvanse and associated names), (EMEA-000553-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:15:00Z","last_updated_date":"2023-04-19T14:15:00Z","reference_number":"EMA/145463/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2022-ema-decision-17-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-lisdexamfetamine-dimesylate-elvanse-associated-names-emea-000553-pip01-09-m05_en.pdf"},
    {"id":"58440","name":"P/0072/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for phospholipid esters from herring roe (HRO350) (EMEA-003053-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:11:00Z","last_updated_date":"2023-04-19T14:11:00Z","reference_number":"EMA/71127/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-phospholipid-esters-herring-roe-hro350-emea-003053-pip01-21_en.pdf"},
    {"id":"58439","name":"P/0117/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for palbociclib (Ibrance), (EMEA-002146-PIP01-17-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T14:07:00Z","last_updated_date":"2023-04-19T14:07:00Z","reference_number":"EMA/149197/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0117-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-palbociclib-ibrance-emea-002146-pip01-17-m04_en.pdf"},
    {"id":"58436","name":"P/0060/2022 - EMA decision of 7 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for L-carnitine/glucose/calcium chloride dihydrate/magnesium chloride hexahydrate/sodium lactate/sodium..(EMA-003049-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T13:47:00Z","last_updated_date":"2023-04-19T13:47:00Z","reference_number":"EMA/107971/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0060-2022-ema-decision-7-march-2022-agreement-paediatric-investigation-plan-granting-deferral-l-carnitine-glucose-calcium-chloride-dihydrate-magnesium-chloride-hexahydrate-sodium-lactate-sodiumema_en.pdf"},
    {"id":"58435","name":"P/0073/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir disoproxil (Viread), (EMEA-000533-PIP01-08-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T13:40:00Z","last_updated_date":"2023-04-19T13:40:00Z","reference_number":"EMA/65153/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2022-ema-decision-11-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-viread-emea-000533-pip01-08-m11_en.pdf"},
    {"id":"58434","name":"P/0061/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for cosibelimab (EMEA-003041-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T13:34:00Z","last_updated_date":"2023-04-19T13:34:00Z","reference_number":"EMA/67516/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0061-2022-ema-decision-11-march-2022-granting-product-specific-waiver-cosibelimab-emea-003041-pip01-21_en.pdf"},
    {"id":"58433","name":"P/0114/2022 - Decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for axicabtagene ciloleucel (Yescarta), (EMEA-002010-PIP01-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T13:37:00Z","last_updated_date":"2023-04-19T13:37:00Z","reference_number":"P/0114/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0114-2022-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-axicabtagene-ciloleucel-yescarta-emea-002010-pip01-16-m03_en.pdf"},
    {"id":"58431","name":"P/0101/2022 : EMA decision of 17 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (Edurant), (EMEA-000317-PIP01-08-M13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:33:00Z","last_updated_date":"2023-04-19T12:33:00Z","reference_number":"EMA/145471/2022 Corr1","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2022-ema-decision-17-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m13_en.pdf"},
    {"id":"58428","name":"P/0142/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for galcanezumab (Emgality), (EMEA-001860-PIP03-16-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:27:00Z","last_updated_date":"2023-04-19T12:27:00Z","reference_number":"EMA/149012/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-galcanezumab-emgality-emea-001860-pip03-16-m07_en.pdf"},
    {"id":"58427","name":"P/0131/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ozanimod (Zeposia), (EMEA-001710-PIP04-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:22:00Z","last_updated_date":"2023-04-19T12:22:00Z","reference_number":"EMA/194368/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-ozanimod-zeposia-emea-001710-pip04-17-m03_en.pdf"},
    {"id":"58425","name":"P/0056/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ralmitaront (EMEA-003003-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:15:00Z","last_updated_date":"2023-04-19T12:15:00Z","reference_number":"EMA/94168/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0056-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ralmitaront-emea-003003-pip01-21_en.pdf"},
    {"id":"58424","name":"P/0135/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bezlotoxumab (Zinplava), (EMEA-001645-PIP01-14-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:13:00Z","last_updated_date":"2023-04-19T12:13:00Z","reference_number":"EMA/194322/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-bezlotoxumab-zinplava-emea-001645-pip01-14-m04_en.pdf"},
    {"id":"58423","name":"P/0128/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for eluxadoline, (EMEA- 001579-PIP01-13-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:08:00Z","last_updated_date":"2023-04-19T12:08:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0128-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-eluxadoline-emea-001579-pip01-13-m05_en.pdf"},
    {"id":"58422","name":"P/0133/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for etelcalcetide (Parsabiv), (EMEA-001554-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T12:00:00Z","last_updated_date":"2023-04-19T12:00:00Z","reference_number":"P/0133/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0133-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-etelcalcetide-parsabiv-emea-001554-pip01-13-m03_en.pdf"},
    {"id":"58421","name":"P/0070/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for CpG 1018/Alum-adjuvanted recombinant SARS-CoV-2 Trimeric Spike (S) protein subunit vaccine....(EMEA-002987-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T11:36:00Z","last_updated_date":"2023-04-19T11:36:00Z","reference_number":"EMA/70884/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-cpg-1018-alum-adjuvanted-recombinant-sars-cov-2-trimeric-spike-s-protein-subunit-vaccineemea-002987_en.pdf"},
    {"id":"58420","name":"P/0132/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for fosdenopterin (ORGN001), (EMEA-001491-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T11:35:00Z","last_updated_date":"2023-04-19T11:35:00Z","reference_number":"EMA/193794/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-fosdenopterin-orgn001-emea-001491-pip01-13-m02_en.pdf"},
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    {"id":"58416","name":"P/0108/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for human IgG4 monoclonal antibody against BCMA and CD3 (ABBV-383), (EMEA-003147-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T11:01:00Z","last_updated_date":"2023-04-19T11:01:00Z","reference_number":"EMA/145624/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0108-2022-ema-decision-13-april-2022-granting-product-specific-waiver-human-igg4-monoclonal-antibody-against-bcma-cd3-abbv-383-emea-003147-pip01-21_en.pdf"},
    {"id":"58415","name":"P/0136/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for esketamine (hydrochloride) (Spravato), (EMEA-001428-PIP03-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T11:00:00Z","last_updated_date":"2023-04-19T11:00:00Z","reference_number":"EMA/157572/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-esketamine-hydrochloride-spravato-emea-001428-pip03-15-m02_en.pdf"},
    {"id":"58413","name":"P/0129/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra), (EMEA-001214-PIP01-11-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T10:49:00Z","last_updated_date":"2023-04-19T10:49:00Z","reference_number":"EMA/157570/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-fasenra-emea-001214-pip01-11-m11_en.pdf"},
    {"id":"58412","name":"P/0111/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for telmisartan / indapamide (EMEA-003151-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T10:45:00Z","last_updated_date":"2023-04-19T10:45:00Z","reference_number":"EMA/145596/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2022-ema-decision-13-april-2022-granting-product-specific-waiver-telmisartan-indapamide-emea-003151-pip01-21_en.pdf"},
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    {"id":"58409","name":"P/0122/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ponatinib (Iclusig), (EMEA-001186-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-19T10:31:00Z","last_updated_date":"2023-04-19T10:31:00Z","reference_number":"EMA/157567/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-ponatinib-iclusig-emea-001186-pip01-11-m03_en.pdf"},
    {"id":"58398","name":"P/0119/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for siponimod (hemifumarate) (Mayzent), (EMEA-000716-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T17:26:00Z","last_updated_date":"2023-04-17T17:26:00Z","reference_number":"EMA/157565/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-siponimod-hemifumarate-mayzent-emea-000716-pip01-09-m04_en.pdf"},
    {"id":"58396","name":"P/0107/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for amikacin (sulfate) (Arikayce liposomal), (EMEA-000525-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T17:10:00Z","last_updated_date":"2023-04-17T17:10:00Z","reference_number":"EMA/145474/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0107-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-amikacin-sulfate-arikayce-liposomal-emea-000525-pip01-08-m08_en.pdf"},
    {"id":"58397","name":"P/0113/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for acetylsalicylic acid / ticagrelor (EMEA-003146-PIP01- 21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T17:17:00Z","last_updated_date":"2023-04-17T17:17:00Z","reference_number":"EMA/148949/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2022-ema-decision-13-april-2022-granting-product-specific-waiver-acetylsalicylic-acid-ticagrelor-emea-003146-pip01-21_en.pdf"},
    {"id":"58395","name":"P/0112/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for cevostamab (EMEA-003145-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T17:03:00Z","last_updated_date":"2023-04-17T17:03:00Z","reference_number":"EMA/148907/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2022-ema-decision-13-april-2022-granting-product-specific-waiver-cevostamab-emea-003145-pip01-21_en.pdf"},
    {"id":"58390","name":"P/0124/2022 : EMA decision of 15 April 2022 on the granting of a product-specific waiver for adalimumab conjugated with (4S)-4-[2-(2- bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)....(EMEA-002927-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T16:10:00Z","last_updated_date":"2023-04-17T16:10:00Z","reference_number":"EMA/149061/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2022-ema-decision-15-april-2022-granting-product-specific-waiver-adalimumab-conjugated-4s-4-2-2-bromoacetamidoacetamido-5-3-4-4ar4bs5s6as6bs8r9ar10as10bsemea-002927-pip02-21_en.pdf"},
    {"id":"58394","name":"P/0105/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) genetically modified....(EMEA-003001-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T16:43:00Z","last_updated_date":"2023-04-17T16:43:00Z","reference_number":"EMA/145564/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-waiver-autologous-cd34-hematopoietic-stem-progenitor-cells-hspcs-genetically-modifiedemea-003001-pip01-21_en.pdf"},
    {"id":"58393","name":"P/0143/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pamrevlumab (EMEA-002979-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T16:27:00Z","last_updated_date":"2023-04-17T16:27:00Z","reference_number":"EMA/149480/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pamrevlumab-emea-002979-pip01-21_en.pdf"},
    {"id":"58391","name":"P/0125/2022 : EMA decision of 15 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benzylamine derivative of benzofuran (BCX9930) (EMEA-002974-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T16:19:00Z","last_updated_date":"2023-04-17T16:19:00Z","reference_number":"EMA/149065/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2022-ema-decision-15-april-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-benzylamine-derivative-benzofuran-bcx9930-emea-002974-pip01-21_en.pdf"},
    {"id":"58388","name":"P/0140/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for sintilimab (EMEA-002919-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T15:59:00Z","last_updated_date":"2023-04-17T15:59:00Z","reference_number":"EMA/157578/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2022-ema-decision-13-april-2022-granting-product-specific-waiver-sintilimab-emea-002919-pip02-21_en.pdf"},
    {"id":"58386","name":"P/0045/2022 : EMA decision of 3 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for imdevimab (Ronapreve), (EMEA-002965-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T15:07:00Z","last_updated_date":"2023-04-17T15:07:00Z","reference_number":"EMA/63282/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2022-ema-decision-3-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-imdevimab-ronapreve-emea-002965-pip01-21-m01_en.pdf"},
    {"id":"58385","name":"P/0141/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for influenza virus A/turkey/Turkey/1/2005 (H5N1) NIBRG-23 strain, HA surface antigen (EMEA-002869-PIP03-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T15:04:00Z","last_updated_date":"2023-04-17T15:04:00Z","reference_number":"EMA/197429/2022 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-waiver-influenza-virus-turkey-turkey-1-2005-h5n1-nibrg-23-strain-ha-surface-antigen-emea-002869-pip03-21_en.pdf"},
    {"id":"58384","name":"P/0044/2022 : EMA decision of 3 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for casirivimab (Ronapreve), (EMEA-002964-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T14:59:00Z","last_updated_date":"2023-04-17T14:59:00Z","reference_number":"EMA/63284/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2022-ema-decision-3-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-casirivimab-ronapreve-emea-002964-pip01-21-m01_en.pdf"},
    {"id":"58383","name":"P/0083/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for viltolarsen (EMEA-002853-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T14:52:00Z","last_updated_date":"2023-04-17T14:52:00Z","reference_number":"EMA/99042/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-viltolarsen-emea-002853-pip01-20_en.pdf"},
    {"id":"58379","name":"P/0139/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for retifanlimab (EMEA-002798-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T14:25:00Z","last_updated_date":"2023-04-17T14:25:00Z","reference_number":"EMA/157576/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2022-ema-decision-13-april-2022-granting-product-specific-waiver-retifanlimab-emea-002798-pip02-21_en.pdf"},
    {"id":"58377","name":"P/0118/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rozanolixizumab (EMEA-002681-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T14:13:00Z","last_updated_date":"2023-04-17T14:13:00Z","reference_number":"EMA/149542/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0118-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rozanolixizumab-emea-002681-pip02-21_en.pdf"},
    {"id":"58376","name":"P/0033/2022 : EMA decision of 1 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518), (EMEA-002706-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T14:12:00Z","last_updated_date":"2023-04-17T14:12:00Z","reference_number":"EMA/18414/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2022-ema-decision-1-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-allogeneic-bone-marrow-derived-mesenchymal-stromal-cells-ex-vivo-expanded-mc0518-emea-002706-pip01_en.pdf"},
    {"id":"58375","name":"P/0049/2022 : EMA decision of 18 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab, (EMEA- 002475-PIP02-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T13:55:00Z","last_updated_date":"2023-04-17T13:55:00Z","reference_number":"EMA/97983/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2022-ema-decision-18-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-spesolimab-emea-002475-pip02-19-m02_en.pdf"},
    {"id":"58374","name":"P/0042/2022 : EMA decision of 10 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigens... (EMEA- 002359-PIP01-18-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T13:43:00Z","last_updated_date":"2023-04-17T13:43:00Z","reference_number":"EMA/65166/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2022-ema-decision-10-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigens-emea-002359-pip01-18-m04_en.pdf"},
    {"id":"58373","name":"P/0080/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for neisseria meningitidis serogroup B fHbp subfamily A / Neisseria....(EMEA-002814-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T13:34:00Z","last_updated_date":"2023-04-17T13:34:00Z","reference_number":"EMA/65205/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-neisseria-meningitidis-serogroup-b-fhbp-subfamily-neisseriaemea-002814-pip02-21_en.pdf"},
    {"id":"58372","name":"P/0138/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for catequentinib (EMEA-002486-PIP04-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T13:26:00Z","last_updated_date":"2023-04-17T13:26:00Z","reference_number":"EMA/157575/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-deferral-catequentinib-emea-002486-pip04-21_en.pdf"},
    {"id":"58371","name":"P/0084/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for vimseltinib (EMEA-002802-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T13:25:00Z","last_updated_date":"2023-04-17T13:25:00Z","reference_number":"EMA/100970/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2022-ema-decision-11-march-2022-granting-product-specific-waiver-vimseltinib-emea-002802-pip02-21_en.pdf"},
    {"id":"58369","name":"P/0422/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for maribavir (EMEA- 000353-PIP02-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T12:40:00Z","last_updated_date":"2023-04-17T12:40:00Z","reference_number":"EMA/825074/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0422-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-maribavir-emea-000353-pip02-16-m02_en.pdf"},
    {"id":"58367","name":"P/0137/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for invimestrocel (EMEA-002317-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T12:09:00Z","last_updated_date":"2023-04-17T12:09:00Z","reference_number":"EMA/157573/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-deferral-invimestrocel-emea-002317-pip02-21_en.pdf"},
    {"id":"58365","name":"P/0120/2022 : EMA decision of 15 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP09-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T11:38:00Z","last_updated_date":"2023-04-17T11:38:00Z","reference_number":"EMA/149062/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2022-ema-decision-15-april-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dupilumab-dupixent-emea-001501-pip09-21_en.pdf"},
    {"id":"58364","name":"P/0041/2022 : EMA decision of of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir (sulphate) / cobicistat (Evotaz), (EMEA-001465-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-17T11:08:00Z","last_updated_date":"2023-04-17T11:08:00Z","reference_number":"EMA/18321/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0041-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-atazanavir-sulphate-cobicistat-evotaz-emea-001465-pip01-13-m04_en.pdf"},
    {"id":"58359","name":"P/0019/2022 : EMA decision of 3 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cysteamine (hydrochloride) (Cystadrops), (EMEA-000322-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T16:01:00Z","last_updated_date":"2023-04-14T16:01:00Z","reference_number":"EMA/782279/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2022-ema-decision-3-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-cysteamine-hydrochloride-cystadrops-emea-000322-pip01-08-m06_en.pdf"},
    {"id":"58360","name":"P/0050/2022 : EMA decision of 24 February 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tedizolid phosphate (Sivextro), (EMEA-001379-PIP01-12-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T16:08:00Z","last_updated_date":"2023-04-14T16:08:00Z","reference_number":"P/0050/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2022-ema-decision-24-february-2022-acceptance-modification-agreed-paediatric-investigation-plan-tedizolid-phosphate-sivextro-emea-001379-pip01-12-m06_en.pdf"},
    {"id":"58358","name":"P/0034/2022 : EMA decision of 4 February 2022 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for insulin efsitora alfa (EMEA-003105-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T15:49:00Z","last_updated_date":"2023-04-14T15:49:00Z","reference_number":"P/0034/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2022-ema-decision-4-february-2022-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-insulin-efsitora-alfa-emea-003105-pip01-21_en.pdf"},
    {"id":"58357","name":"P/0130/2022 : EMA decision of 13 April 2022 on the granting of a product-specific waiver for secukinumab (Cosentyx), (EMEA-000380-PIP09-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T15:35:00Z","last_updated_date":"2023-04-14T15:35:00Z","reference_number":"EMA/193522/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2022-ema-decision-13-april-2022-granting-product-specific-waiver-secukinumab-cosentyx-emea-000380-pip09-21_en.pdf"},
    {"id":"58352","name":"P/0014/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for gemtuzumab ozogamicin (Mylotarg), (EMEA-001733-PIP02-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T11:26:00Z","last_updated_date":"2023-04-14T11:26:00Z","reference_number":"EMA/18515/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-gemtuzumab-ozogamicin-mylotarg-emea-001733-pip02-15-m02_en.pdf"},
    {"id":"58350","name":"P/0545/2021 : EMA decision of 4 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T10:56:00Z","last_updated_date":"2023-04-14T10:56:00Z","reference_number":"EMA/709753/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0545-2021-ema-decision-4-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-nemolizumab-emea-001624-pip01-14-m04_en.pdf"},
    {"id":"58349","name":"P/0039/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP02-13-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-14T10:31:00Z","last_updated_date":"2023-04-14T10:31:00Z","reference_number":"EMA/18201/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-dupixent-emea-001501-pip02-13-m07_en.pdf"},
    {"id":"58345","name":"P/0109/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ferumoxytol, (EMEA-000373-PIP02-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-13T17:59:00Z","last_updated_date":"2023-04-13T17:59:00Z","reference_number":"EMA/145472/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-ferumoxytol-emea-000373-pip02-09-m05_en.pdf"},
    {"id":"58344","name":"P/0106/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for saxagliptin (Onglyza), (EMEA-000200-PIP01-08-M09)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-04-13T17:17:00Z","last_updated_date":"2023-04-13T17:17:00Z","reference_number":"EMA/145470/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-saxagliptin-onglyza-emea-000200-pip01-08-m09_en.pdf"},
    {"id":"58343","name":"P/0110/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cannabidiol / delta-9- tetrahydrocannabinol (Sativex), (EMEA-000181-PIP01-08-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-04-13T16:47:00Z","last_updated_date":"2023-04-13T16:47:00Z","reference_number":"EMA/145466/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2022-ema-decision-13-april-2022-acceptance-modification-agreed-paediatric-investigation-plan-cannabidiol-delta-9-tetrahydrocannabinol-sativex-emea-000181-pip01-08-m06_en.pdf"},
    {"id":"58342","name":"P/0085/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for parsaclisib (as hydrochloride) (EMEA-002696-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-13T16:13:00Z","last_updated_date":"2023-04-13T16:13:00Z","reference_number":"EMA/99627/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0085-2022-ema-decision-11-march-2022-granting-product-specific-waiver-parsaclisib-hydrochloride-emea-002696-pip02-21_en.pdf"},
    {"id":"58341","name":"P/0078/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efgartigimod alfa (EMEA-002597-PIP04-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-13T15:41:00Z","last_updated_date":"2023-04-13T15:41:00Z","reference_number":"EMA/65203/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-efgartigimod-alfa-emea-002597-pip04-21_en.pdf"},
    {"id":"58340","name":"P/0055/2022 : EMA decision of 11 March 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant humanized anti-blood dendritic cell antigen 2.. (EMEA-002555-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-13T15:32:00Z","last_updated_date":"2023-04-13T15:32:00Z","reference_number":"EMA/94153/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2022-ema-decision-11-march-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-humanized-anti-blood-dendritic-cell-antigen-2-emea-002555-pip02-21_en.pdf"},
    {"id":"58339","name":"EMA decision of 11 March 2022 on the granting of a product specific waiver for tucatinib (Tukysa) (EMEA-002242-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-13T14:58:00Z","last_updated_date":"2023-04-13T14:58:00Z","reference_number":"EMA/65200/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-decision-11-march-2022-granting-product-specific-waiver-tucatinib-tukysa-emea-002242-pip02-21_en.pdf"},
    {"id":"58338","name":"P/0079/2022 : EMA decision of 11 March 2022 on the granting of a product specific waiver for (1S,3S)-3-({2-methyl-6-[1-methyl-5- ({[methyl(propyl)carbamoyl]oxy}methyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl}oxy)....(BMS-986278) (EMEA-001649-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-13T14:36:00Z","last_updated_date":"2023-04-13T14:36:00Z","reference_number":"EMA/65197/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2022-ema-decision-11-march-2022-granting-product-specific-waiver-1s3s-3-2-methyl-6-1-methyl-5-methylpropylcarbamoyloxymethyl-1h-123-triazol-4-ylpyridin-3-yloxybms-986278-emea-001649-pip02-21_en.pdf"},
    {"id":"58334","name":"P/0026/2022: EMA decision of 4 February 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ExPEC9V (EMEA-002996-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T17:36:00Z","last_updated_date":"2023-04-12T17:36:00Z","reference_number":"EMA/11870/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2022-ema-decision-4-february-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-expec9v-emea-002996-pip01-21_en.pdf"},
    {"id":"58333","name":"P/0040/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cabotegravir (Vocabria), (EMEA-001418-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T17:20:00Z","last_updated_date":"2023-04-12T17:20:00Z","reference_number":"EMA/18253/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-cabotegravir-vocabria-emea-001418-pip01-13-m04_en.pdf"},
    {"id":"58332","name":"P/0001/2022 : EMA decision of 7 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime / avibactam (Zavicefta), (EMEA-001313-PIP01-12-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T16:21:00Z","last_updated_date":"2023-04-12T16:21:00Z","reference_number":"EMA/5005/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2022-ema-decision-7-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-ceftazidime-avibactam-zavicefta-emea-001313-pip01-12-m11_en.pdf"},
    {"id":"58331","name":"P/0005/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for talimogene laherparepvec (Imlygic), (EMEA-001251-PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T15:33:00Z","last_updated_date":"2023-04-12T15:33:00Z","reference_number":"EMA/782282/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-talimogene-laherparepvec-imlygic-emea-001251-pip01-11-m05_en.pdf"},
    {"id":"58330","name":"P/0002/2022: EMA decision of 7 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dexmedetomidine (hydrochloride), (EMEA-002758-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T15:31:00Z","last_updated_date":"2023-04-12T15:31:00Z","reference_number":"EMA/3938/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2022-ema-decision-7-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-dexmedetomidine-hydrochloride-emea-002758-pip01-19-m01_en.pdf"},
    {"id":"58329","name":"P/0004/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP01-11-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T14:50:00Z","last_updated_date":"2023-04-12T14:50:00Z","reference_number":"EMA/782281/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-olumiant-emea-001220-pip01-11-m06_en.pdf"},
    {"id":"58318","name":"P/0009/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for favezelimab / pembrolizumab (EMEA-003104-PIP01- 21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T11:53:00Z","last_updated_date":"2023-04-12T11:53:00Z","reference_number":"EMA/782285/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2022-ema-decision-31-january-2022-granting-product-specific-waiver-favezelimab-pembrolizumab-emea-003104-pip01-21_en.pdf"},
    {"id":"58321","name":"P/0010/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for aumolertinib (EMEA-003106-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T12:27:00Z","last_updated_date":"2023-04-12T12:27:00Z","reference_number":"EMA/782286/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2022-ema-decision-31-january-2022-granting-product-specific-waiver-aumolertinib-emea-003106-pip01-21_en.pdf"},
    {"id":"58322","name":"P/0011/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for gantenerumab (EMEA-003107-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T12:50:00Z","last_updated_date":"2023-04-12T12:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2022-ema-decision-31-january-2022-granting-product-specific-waiver-gantenerumab-emea-003107-pip01-21_en.pdf"},
    {"id":"58326","name":"P/0012/2022 : EMA decision of 31 January 2022 on the granting of a product-specific waiver for derivative of pyrrolopyrimidine (EMEA-003109- PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T13:37:00Z","last_updated_date":"2023-04-12T13:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2022-ema-decision-31-january-2022-granting-product-specific-waiver-derivative-pyrrolopyrimidine-emea-003109-pip01-21_en.pdf"},
    {"id":"58325","name":"P/0555/2021: EMA decision of 4 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for giroctocogene fitelparvovec, (EMEA-002724-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T13:20:00Z","last_updated_date":"2023-04-12T13:20:00Z","reference_number":"EMA/709767/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0555-2021-ema-decision-4-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-giroctocogene-fitelparvovec-emea-002724-pip01-19-m02_en.pdf"},
    {"id":"58324","name":"P/0030/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mitapivat (EMEA-002684-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T13:13:00Z","last_updated_date":"2023-04-12T13:13:00Z","reference_number":"EMA/18783/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-mitapivat-emea-002684-pip01-19-m01_en.pdf"},
    {"id":"58323","name":"P/0017/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for phenobarbital (EMEA- 002532-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T13:03:00Z","last_updated_date":"2023-04-12T13:03:00Z","reference_number":"EMA/8189/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-phenobarbital-emea-002532-pip01-18-m02_en.pdf"},
    {"id":"58320","name":"P/0016/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for avapritinib (Ayvakyt), (EMEA-002358-PIP02-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T12:15:00Z","last_updated_date":"2023-04-12T12:15:00Z","reference_number":"EMA/8025/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-avapritinib-ayvakyt-emea-002358-pip02-18-m02_en.pdf"},
    {"id":"58317","name":"P/0015/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for onasemnogene abeparvovec (Zolgensma), (EMEA-002168-PIP01-17-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T11:44:00Z","last_updated_date":"2023-04-12T11:44:00Z","reference_number":"EMA/7958/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-onasemnogene-abeparvovec-zolgensma-emea-002168-pip01-17-m04_en.pdf"},
    {"id":"58315","name":"P/0013/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for budesonide / glycopyrronium bromide / formoterol (fumarate) (Trixeo Aerosphere), (EMEA-002063-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T11:30:00Z","last_updated_date":"2023-04-12T11:30:00Z","reference_number":"EMA/7910/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-budesonide-glycopyrronium-bromide-formoterol-fumarate-trixeo-aerosphere-emea-002063-pip01-16-m01_en.pdf"},
    {"id":"58314","name":"P/0028/2022 : EMA decision of 31 January 2022 on the granting of a product specific waiver for colchicine (EMEA-003101-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T11:23:00Z","last_updated_date":"2023-04-12T11:23:00Z","reference_number":"EMA/12322/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2022-ema-decision-31-january-2022-granting-product-specific-waiver-colchicine-emea-003101-pip01-21_en.pdf"},
    {"id":"58313","name":"P/0024/2022: EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vadadustat (EMEA- 001944-PIP01-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-12T11:09:00Z","last_updated_date":"2023-04-12T11:09:00Z","reference_number":"EMA/18986/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0024-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-vadadustat-emea-001944-pip01-16-m03_en.pdf"},
    {"id":"58288","name":"P/0020/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for ribociclib (Kisqali), (EMEA-002765-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T12:32:00Z","last_updated_date":"2023-04-05T12:32:00Z","reference_number":"EMA/8294/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-waiver-ribociclib-kisqali-emea-002765-pip02-21_en.pdf"},
    {"id":"58291","name":"P/0007/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a waiver for vorasidenib (as hemicitrate, hemihydrate salt) (EMEA-002932-PIP02-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-04-05T13:57:00Z","last_updated_date":"2023-04-05T13:57:00Z","reference_number":"EMA/12217/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-waiver-vorasidenib-hemicitrate-hemihydrate-salt-emea-002932-pip02-21_en.pdf"},
    {"id":"58294","name":"P/0023/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aficamten (EMEA-002958-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T15:22:00Z","last_updated_date":"2023-04-05T15:22:00Z","reference_number":"EMA/8373/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aficamten-emea-002958-pip01-21_en.pdf"},
    {"id":"58297","name":"P/0032/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for nirogacestat hydrobromide (EMEA-002971-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T15:57:00Z","last_updated_date":"2023-04-05T15:57:00Z","reference_number":"EMA/10020/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-nirogacestat-hydrobromide-emea-002971-pip01-21_en.pdf"},
    {"id":"58299","name":"P/0025/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2-Amino-N-(4-hydroxybicyclo[2.2.2]octan...(EMEA-002992-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T16:34:00Z","last_updated_date":"2023-04-05T16:34:00Z","reference_number":"EMA/11809/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2-amino-n-4-hydroxybicyclo222octanemea-002992-pip01-21_en.pdf"},
    {"id":"58298","name":"P/0008/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for single strain of non-genetically modified Prevotella his...  (EMEA- 002933-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T16:12:00Z","last_updated_date":"2023-04-05T16:12:00Z","reference_number":"EMA/9458/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-single-strain-non-genetically-modified-prevotella-his-emea-002933-pip01-20_en.pdf"},
    {"id":"58300","name":"P/0022/2022 : EMA decision of 31 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for lanadelumab (Takhzyro), (EMEA-001864-PIP01-15-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T17:08:00Z","last_updated_date":"2023-04-05T17:08:00Z","reference_number":"EMA/18778/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2022-ema-decision-31-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-lanadelumab-takhzyro-emea-001864-pip01-15-m06_en.pdf"},
    {"id":"58286","name":"P/0003/2022 : EMA decision of 18 January 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (Briviact), (EMEA-000332-PIP02-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T11:18:00Z","last_updated_date":"2023-04-05T11:18:00Z","reference_number":"EMA/782280/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0003-2022-ema-decision-18-january-2022-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-briviact-emea-000332-pip02-17-m03_en.pdf"},
    {"id":"58285","name":"P/0018/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for izencitinib (EMEA-002757-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-04-05T10:51:00Z","last_updated_date":"2023-04-05T10:51:00Z","reference_number":"EMA/8212/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-izencitinib-emea-002757-pip02-21_en.pdf"},
    {"id":"58231","name":"P/0454/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for vericiguat (Verquvo), (EMEA-001636-PIP01-14-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-30T16:31:00Z","last_updated_date":"2023-03-30T16:31:00Z","reference_number":"EMA/775666/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0454-2022-ema-decision-28-october-2022-acceptance-modification-agreed-paediatric-investigation-plan-vericiguat-verquvo-emea-001636-pip01-14-m03_en.pdf"},
    {"id":"58217","name":"P/0513/2022 : EMA decision of 4 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for givinostat (EMEA-000551-PIP04-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-30T12:14:00Z","last_updated_date":"2023-03-30T12:14:00Z","reference_number":"EMA/912401/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0513-2022-ema-decision-4-december-2022-acceptance-modification-agreed-paediatric-investigation-plan-givinostat-emea-000551-pip04-21-m01_en.pdf"},
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    {"id":"58206","name":"P/0486/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for baloxavir marboxil (Xofluza), (EMEA-002440-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-29T16:17:00Z","last_updated_date":"2023-03-29T16:17:00Z","reference_number":"EMA/626832/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0486-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-baloxavir-marboxil-xofluza-emea-002440-pip01-18-m02_en.pdf"},
    {"id":"58200","name":"P/0492/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain... (EMEA- 002068-PIP01-16-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-29T12:46:00Z","last_updated_date":"2023-03-29T12:46:00Z","reference_number":"EMA/627653/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0492-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-emea-002068-pip01-16-m04_en.pdf"},
    {"id":"58198","name":"P/0490/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cyclophosphamide (Zenew and associated names), (EMEA-002644-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-29T12:46:00Z","last_updated_date":"2023-03-29T12:46:00Z","reference_number":"EMA/627032/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0490-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-cyclophosphamide-zenew-associated-names-emea-002644-pip01-19-m01_en.pdf"},
    {"id":"58197","name":"P/0484/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for deferoxamine (mesylate) / histidine / tryptophan / aspartic acid... (EMEA-002735-PIP03-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-29T12:20:00Z","last_updated_date":"2023-03-29T12:20:00Z","reference_number":"EMA/627334/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0484-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-deferoxamine-mesylate-histidine-tryptophan-aspartic-acid-emea-002735-pip03-20-m01_en.pdf"},
    {"id":"58196","name":"P/0483/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for severe acute respiratory syndrome coronavirus 2 recombinant... (EMEA-002941-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-29T12:20:00Z","last_updated_date":"2023-03-29T12:20:00Z","reference_number":"EMA/627540/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0483-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-severe-acute-respiratory-syndrome-coronavirus-2-recombinant-emea-002941-pip01-20-m01_en.pdf"},
    {"id":"58187","name":"P/0476/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for vericiguat (Verguvo), (EMEA-001636-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T13:17:00Z","last_updated_date":"2023-03-28T13:17:00Z","reference_number":"EMA/627442/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0476-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-vericiguat-verguvo-emea-001636-pip01-14-m02_en.pdf"},
    {"id":"58186","name":"P/0475/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for erenumab (Aimovig), (EMEA-001664-PIP02-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T13:17:00Z","last_updated_date":"2023-03-28T13:17:00Z","reference_number":"EMA/627444/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0475-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-erenumab-aimovig-emea-001664-pip02-15-m05_en.pdf"},
    {"id":"58185","name":"P/0478/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for inotuzumab ozogamicin (Besponsa), (EMEA-001429-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T12:12:00Z","last_updated_date":"2023-03-28T12:12:00Z","reference_number":"EMA/627438/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0478-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-inotuzumab-ozogamicin-besponsa-emea-001429-pip01-13-m04_en.pdf"},
    {"id":"58184","name":"P/0479/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for isavuconazonium (sulfate) (Cresemba), (EMEA-001301-PIP02-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T12:12:00Z","last_updated_date":"2023-03-28T12:12:00Z","reference_number":"EMA/627435/2021 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0479-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-isavuconazonium-sulfate-cresemba-emea-001301-pip02-12-m04_en.pdf"},
    {"id":"58182","name":"P/0558/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for lisocabtagene maraleucel (EMEA-001995-PIP01-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T11:57:00Z","last_updated_date":"2023-03-28T11:57:00Z","reference_number":"EMA/708327/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0558-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-lisocabtagene-maraleucel-emea-001995-pip01-16-m03_en.pdf"},
    {"id":"58181","name":"P/0554/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fully human IgG1 RB- 1 YTE anti-RSV F monoclonal antibody (MK-1654), (EMEA-002755-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T11:57:00Z","last_updated_date":"2023-03-28T11:57:00Z","reference_number":"EMA/709698/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0554-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-fully-human-igg1-rb-1-yte-anti-rsv-f-monoclonal-antibody-mk-1654-emea-002755-pip01-19-m01_en.pdf"},
    {"id":"58180","name":"P/0562/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for palovarotene (EMEA-001662-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T11:37:00Z","last_updated_date":"2023-03-28T11:37:00Z","reference_number":"EMA/649951/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0562-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-palovarotene-emea-001662-pip01-14-m05_en.pdf"},
    {"id":"58179","name":"P/0561/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for estetrol / drospirenone (Lydisilka), (EMEA-001332-PIP01-12-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-28T11:37:00Z","last_updated_date":"2023-03-28T11:37:00Z","reference_number":"EMA/706126/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0561-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-estetrol-drospirenone-lydisilka-emea-001332-pip01-12-m05_en.pdf"},
    {"id":"58178","name":"P/0565/2021 : EMA decision of 21 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for glycopyrronium bromide, (EMEA-002383-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-27T18:00:00Z","last_updated_date":"2023-03-27T18:00:00Z","reference_number":"EMA/628072/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0565-2021-ema-decision-21-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-glycopyrronium-bromide-emea-002383-pip01-18-m01_en.pdf"},
    {"id":"58177","name":"P/0546/2021: EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-27T16:48:00Z","last_updated_date":"2023-03-27T16:48:00Z","reference_number":"EMA/709533/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0546-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-avelumab-bavencio-emea-001849-pip02-15-m04_en.pdf"},
    {"id":"58176","name":"P/0547/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tozinameran (Comirnaty), (EMEA-002861-PIP02-20-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-27T16:48:00Z","last_updated_date":"2023-03-27T16:48:00Z","reference_number":"EMA/709824/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0547-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-tozinameran-comirnaty-emea-002861-pip02-20-m03_en.pdf"},
    {"id":"58172","name":"P/0541/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nedosiran (DCRPHXC) (EMEA-002493-PIP01-18-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-27T16:16:00Z","last_updated_date":"2023-03-27T16:16:00Z","reference_number":"EMA/699441/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0541-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-nedosiran-dcrphxc-emea-002493-pip01-18-m03_en.pdf"},
    {"id":"58135","name":"P/0103/2022 : EMA decision of 21 March 2022 on the agreement of a paediatric investigation plan for censavudine (EMEA-003075-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-23T16:02:00Z","last_updated_date":"2023-03-23T16:02:00Z","reference_number":"EMA/149068/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2022-ema-decision-21-march-2022-agreement-paediatric-investigation-plan-censavudine-emea-003075-pip01-21_en.pdf"},
    {"id":"58133","name":"P/0076/2022 : EMA decision of 11 March 2022 on the acceptance of a modification of an agreed paediatric investigation plan for imlifidase (Idefirix) (EMEA-002183-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-23T12:35:00Z","last_updated_date":"2023-03-23T12:35:00Z","reference_number":"EMA/65167/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2022-ema-decision-11-march-2022-acceptance-modification-agreed-paediatric-investigation-plan-imlifidase-idefirix-emea-002183-pip01-17-m01_en.pdf"},
    {"id":"58128","name":"P/0536/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for alpelisib (Piqray and associated names), (EMEA-002016-PIP03-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-22T17:59:00Z","last_updated_date":"2023-03-22T17:59:00Z","reference_number":"EMA/707287/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0536-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-alpelisib-piqray-associated-names-emea-002016-pip03-19-m01_en.pdf"},
    {"id":"58126","name":"P/0528/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy), (EMEA-001766-PIP01-15-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-22T17:02:00Z","last_updated_date":"2023-03-22T17:02:00Z","reference_number":"EMA/627163/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0528-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-bictegravir-emtricitabine-tenofovir-alafenamide-biktarvy-emea-001766-pip01-15-m04_en.pdf"},
    {"id":"58125","name":"P/0524/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-22T16:36:00Z","last_updated_date":"2023-03-22T16:36:00Z","reference_number":"EMA/627063/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0524-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-dolutegravir-juluca-emea-001750-pip01-15-m05_en.pdf"},
    {"id":"58113","name":"P/0516/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for marstacimab, (EMEA-002285-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-22T10:16:00Z","last_updated_date":"2023-03-22T10:16:00Z","reference_number":"EMA/628069/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0516-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-marstacimab-emea-002285-pip02-19-m01_en.pdf"},
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    {"id":"58111","name":"P/0514/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for evinacumab (Evkeeza), (EMEA-002298-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-22T10:16:00Z","last_updated_date":"2023-03-22T10:16:00Z","reference_number":"EMA/628071/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0514-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-evinacumab-evkeeza-emea-002298-pip01-17-m03_en.pdf"},
    {"id":"58106","name":"P/0510/2021 : EMA decision of  3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T17:48:00Z","last_updated_date":"2023-03-21T17:48:00Z","reference_number":"EMA/627654/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0510-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-rinvoq-emea-001741-pip01-14-m05_en.pdf"},
    {"id":"58105","name":"P/0509/2021 : EMA decision of  3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for molgramostim, (EMEA-002282-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T17:48:00Z","last_updated_date":"2023-03-21T17:48:00Z","reference_number":"EMA/628038/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0509-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-molgramostim-emea-002282-pip01-17-m01_en.pdf"},
    {"id":"58103","name":"P/0359/2022: EMA decision of 22 August 2022 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon beta-1a (Plegridy), (EMEA-001129-PIP01-11-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-03-21T17:43:00Z","last_updated_date":"2023-03-21T17:43:00Z","reference_number":"EMA/693766/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0359-2022-ema-decision-22-august-2022-acceptance-modification-agreed-paediatric-investigation-plan-peginterferon-beta-1a-plegridy-emea-001129-pip01-11-m05_en.pdf"},
    {"id":"58100","name":"P/0507/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pretomanid, (EMEA-002115-PIP01-17-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T15:53:00Z","last_updated_date":"2023-03-21T15:53:00Z","reference_number":"EMA/627978/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0507-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-pretomanid-emea-002115-pip01-17-m04_en.pdf"},
    {"id":"58098","name":"P/0506/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cotadutide, (EMEA- 002287-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T15:31:00Z","last_updated_date":"2023-03-21T15:31:00Z","reference_number":"EMA/628070/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0506-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-cotadutide-emea-002287-pip01-17-m03_en.pdf"},
    {"id":"58093","name":"P/0505/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for lumasiran (ALN-GO1) (Oxlumo), (EMEA-002079-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T15:04:00Z","last_updated_date":"2023-03-21T15:04:00Z","reference_number":"EMA/627935/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0505-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-lumasiran-aln-go1-oxlumo-emea-002079-pip01-16-m02_en.pdf"},
    {"id":"58089","name":"P/0502/2021: EMA decision of 2 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fenfluramine  (hydrochloride) (Fintepla), (EMEA-001990-PIP01-16-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-21T11:26:00Z","last_updated_date":"2023-03-21T11:26:00Z","reference_number":"EMA/698179/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0502-2021-ema-decision-2-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-fenfluramine-hydrochloride-fintepla-emea-001990-pip01-16-m04_en.pdf"},
    {"id":"57870","name":"P/0543/2021 : EMA decision of 31 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for vatiquinone (EMEA-001238-PIP03-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-02T17:45:00Z","last_updated_date":"2023-03-02T17:45:00Z","reference_number":"EMA/699703/2021 corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0543-2021-ema-decision-31-december-2021-agreement-paediatric-investigation-plan-granting-deferral-vatiquinone-emea-001238-pip03-21_en.pdf"},
    {"id":"58056","name":"P/0498/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Tenkasi), (EMEA-001270-PIP01-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T17:49:00Z","last_updated_date":"2023-03-16T17:49:00Z","reference_number":"EMA/616492/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0498-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-oritavancin-diphosphate-tenkasi-emea-001270-pip01-12-m04_en.pdf"},
    {"id":"58055","name":"P/0535/2021: EMA decision of 6 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for eribulin (Halaven), (EMEA-001261-PIP01-11-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T17:25:00Z","last_updated_date":"2023-03-16T17:25:00Z","reference_number":"EMA/699482/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0535-2021-ema-decision-6-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-eribulin-halaven-emea-001261-pip01-11-m07_en.pdf"},
    {"id":"58052","name":"P/0496/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tecovirimat (monohydrate) (EMEA-001205-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T15:51:00Z","last_updated_date":"2023-03-16T15:51:00Z","reference_number":"EMA/616460/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0496-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-tecovirimat-monohydrate-emea-001205-pip02-19-m01_en.pdf"},
    {"id":"58050","name":"P/0495/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for regorafenib (Stivarga), (EMEA-001178-PIP01-11-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T15:15:00Z","last_updated_date":"2023-03-16T15:15:00Z","reference_number":"EMA/616451/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0495-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-regorafenib-stivarga-emea-001178-pip01-11-m06_en.pdf"},
    {"id":"58049","name":"P/0550/2021 : EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for alirocumab (Praluent), (EMEA-001169-PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T15:01:00Z","last_updated_date":"2023-03-16T15:01:00Z","reference_number":"EMA/706959/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0550-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-alirocumab-praluent-emea-001169-pip01-11-m05_en.pdf"},
    {"id":"58046","name":"P/0494/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for vonicog alfa (Veyvondi), (EMEA-001164-PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T13:59:00Z","last_updated_date":"2023-03-16T13:59:00Z","reference_number":"EMA/616450/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0494-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-vonicog-alfa-veyvondi-emea-001164-pip01-11-m05_en.pdf"},
    {"id":"58041","name":"P/0493/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for naloxegol (Moventig), (EMEA-001146-PIP01-11-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T12:11:00Z","last_updated_date":"2023-03-16T12:11:00Z","reference_number":"EMA/616446/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0493-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-naloxegol-moventig-emea-001146-pip01-11-m07_en.pdf"},
    {"id":"58040","name":"P/0551/2021: EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T11:39:00Z","last_updated_date":"2023-03-16T11:39:00Z","reference_number":"EMA/707021/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0551-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-romosozumab-evenity-emea-001075-pip04-15-m04_en.pdf"},
    {"id":"58039","name":"P/0480/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for macitentan (Opsumit), (EMEA-001032-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-16T11:22:00Z","last_updated_date":"2023-03-16T11:22:00Z","reference_number":"EMA/616445/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0480-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-macitentan-opsumit-emea-001032-pip01-10-m04_en.pdf"},
    {"id":"58035","name":"P/0527/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP04-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-15T17:56:00Z","last_updated_date":"2023-03-15T17:56:00Z","reference_number":"EMA/626980/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0527-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-ruxolitinib-phosphate-jakavi-emea-000901-pip04-17-m02_en.pdf"},
    {"id":"58034","name":"P/0552/2021 - EMA decision of 31 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (Entyvio), (EMEA-000645-PIP01-09-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-15T17:43:00Z","last_updated_date":"2023-03-15T17:43:00Z","reference_number":"EMA/707074/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0552-2021-ema-decision-31-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-vedolizumab-entyvio-emea-000645-pip01-09-m08_en.pdf"},
    {"id":"58033","name":"P/0521/2021 : EMA decision of of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-15T17:27:00Z","last_updated_date":"2023-03-15T17:27:00Z","reference_number":"EMA/626828/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0521-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m15_en.pdf"},
    {"id":"58032","name":"P/0526/2021 : EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names), (EMEA-000347-PIP02-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-15T17:05:00Z","last_updated_date":"2023-03-15T17:05:00Z","reference_number":"EMA/626801/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0526-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-associated-names-emea-000347-pip02-16-m03_en.pdf"},
    {"id":"58031","name":"P/0525/2021: EMA decision of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for methoxyflurane (Penthrox), (EMEA-000334-PIP01-08-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-15T16:44:00Z","last_updated_date":"2023-03-15T16:44:00Z","reference_number":"EMA/626393/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0525-2021-ema-decision-3-december-2021-acceptance-modification-agreed-paediatric-investigation-plan-methoxyflurane-penthrox-emea-000334-pip01-08-m10_en.pdf"},
    {"id":"58020","name":"P/0511/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for adagrasib, (EMEA-003068-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-14T14:31:00Z","last_updated_date":"2023-03-14T14:31:00Z","reference_number":"EMA/623952/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0511-2021-ema-decision-3-december-2021-granting-product-specific-waiver-adagrasib-emea-003068-pip01-21_en.pdf"},
    {"id":"58025","name":"P/0557/2021 : EMA decision of 31 December 2021 on the granting of a product-specific waiver for paracetamol / acetylcysteine / phenylephrine (EMEA-003091-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-14T16:18:00Z","last_updated_date":"2023-03-14T16:18:00Z","reference_number":"EMA/707275/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0557-2021-ema-decision-31-december-2021-granting-product-specific-waiver-paracetamol-acetylcysteine-phenylephrine-emea-003091-pip01-21_en.pdf"},
    {"id":"58024","name":"P/0564/2021 : EMA decision of 31 December 2021 on the granting of a product specific waiver for humanised IgG2k Fc-modified bispecific antibody against CD3 and BCMA (PF-06863135), (EMEA-003083-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-14T15:53:00Z","last_updated_date":"2023-03-14T15:53:00Z","reference_number":"EMA/649839/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0564-2021-ema-decision-31-december-2021-granting-product-specific-waiver-humanised-igg2k-fc-modified-bispecific-antibody-against-cd3-bcma-pf-06863135-emea-003083-pip01-21_en.pdf"},
    {"id":"58023","name":"P/0501/2021 - EMA decision of 3 December 2021 on the refusal of a paediatric investigation plan and on the granting of a waiver for human normal immunoglobulin (EMEA-003076-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-14T15:23:00Z","last_updated_date":"2023-03-14T15:23:00Z","reference_number":"EMA/616604/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0501-2021-ema-decision-3-december-2021-refusal-paediatric-investigation-plan-granting-waiver-human-normal-immunoglobulin-emea-003076-pip01-21_en.pdf"},
    {"id":"58022","name":"P/0513/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for ramipril / amlodipine (besilate), (EMEA-003070-PIP01- 21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-14T15:14:00Z","last_updated_date":"2023-03-14T15:14:00Z","reference_number":"EMA/624526/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0513-2021-ema-decision-3-december-2021-granting-product-specific-waiver-ramipril-amlodipine-besilate-emea-003070-pip01-21_en.pdf"},
    {"id":"58021","name":"P/0512/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for adavosertib, (EMEA-003069-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-14T14:46:00Z","last_updated_date":"2023-03-14T14:46:00Z","reference_number":"EMA/624475/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0512-2021-ema-decision-3-december-2021-granting-product-specific-waiver-adavosertib-emea-003069-pip01-21_en.pdf"},
    {"id":"58015","name":"P/0489/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for diphtheria toxoid, tetanus toxoid, bordetella pertussis antigen: pertussis toxoid, bordetella pertussis antigen... (EMEA-003066-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T17:47:00Z","last_updated_date":"2023-03-13T17:47:00Z","reference_number":"EMA/632050/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0489-2021-ema-decision-3-december-2021-granting-product-specific-waiver-diphtheria-toxoid-tetanus-toxoid-bordetella-pertussis-antigen-pertussis-toxoid-bordetella-pertussis-antigen-emea-003066-pip01_en.pdf"},
    {"id":"58012","name":"P/0488/2021 : EMA decision of  December 2021 on the granting of a product specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T16:52:00Z","last_updated_date":"2023-03-13T16:52:00Z","reference_number":"EMA/632017/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0488-2021-ema-decision-december-2021-granting-product-specific-waiver-eplerenone-furosemide-emea-003065-pip01-21_en.pdf"},
    {"id":"58011","name":"P/0485/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for vibostolimab / pembrolizumab (EMEA-003063-PIP01- 21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T16:31:00Z","last_updated_date":"2023-03-13T16:31:00Z","reference_number":"EMA/631980/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0485-2021-ema-decision-3-december-2021-granting-product-specific-waiver-vibostolimab-pembrolizumab-emea-003063-pip01-21_en.pdf"},
    {"id":"58007","name":"P/0471/2021 : EMA decision of 3 December 2021 on the granting of a product specific waiver for ofranergene obadenovec (EMEA-003062-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T16:03:00Z","last_updated_date":"2023-03-13T16:03:00Z","reference_number":"EMA/627460/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0471-2021-ema-decision-3-december-2021-granting-product-specific-waiver-ofranergene-obadenovec-emea-003062-pip01-21_en.pdf"},
    {"id":"58006","name":"P/0472/2021 : EMA decision of of 3 December 2021 on the granting of a product specific waiver for otenaproxesul (EMEA-003061-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T15:44:00Z","last_updated_date":"2023-03-13T15:44:00Z","reference_number":"EMA/627459/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0472-2021-ema-decision-3-december-2021-granting-product-specific-waiver-otenaproxesul-emea-003061-pip01-21_en.pdf"},
    {"id":"58004","name":"P/0504/2021 - EMA decision of of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver ... (EMEA-002981-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T15:19:00Z","last_updated_date":"2023-03-13T15:19:00Z","reference_number":"EMA/624102/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0504-2021-ema-decision-3-december-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-emea-002981-pip01-21_en.pdf"},
    {"id":"58003","name":"P/0508/2021 - EMA decision of of 3 December 2021 on the granting of a product specific waiver for pamrevlumab, (EMEA-002979-PIP03-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-13T15:09:00Z","last_updated_date":"2023-03-13T15:09:00Z","reference_number":"EMA/624231/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0508-2021-ema-decision-3-december-2021-granting-product-specific-waiver-pamrevlumab-emea-002979-pip03-21_en.pdf"},
    {"id":"57997","name":"P/0473/2021 - EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant Neisseria... (EMEA-002954-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-10T17:37:00Z","last_updated_date":"2023-03-10T17:37:00Z","reference_number":"P/0473/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0473-2021-ema-decision-3-december-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-neisseria-emea-002954-pip02-21_en.pdf"},
    {"id":"57992","name":"P/0537/2021 ; EMA decision of 9 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for exebacase (EMEA-002947-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-10T15:52:00Z","last_updated_date":"2023-03-10T15:52:00Z","reference_number":"P/0537/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0537-2021-ema-decision-9-december-2021-agreement-paediatric-investigation-plan-granting-deferral-exebacase-emea-002947-pip01-20_en.pdf"},
    {"id":"57991","name":"P/0500/2021 : EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for peptide derivative of... (EMEA-002942-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-10T15:28:00Z","last_updated_date":"2023-03-10T15:28:00Z","reference_number":"EMA/616523/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0500-2021-ema-decision-3-december-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-peptide-derivative-emea-002942-pip01-20_en.pdf"},
    {"id":"57990","name":"P/0553/2021 : EMA decision of 31 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for molnupiravir (EMEA-002940-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-10T15:13:00Z","last_updated_date":"2023-03-10T15:13:00Z","reference_number":"EMA/707172/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0553-2021-ema-decision-31-december-2021-agreement-paediatric-investigation-plan-granting-deferral-molnupiravir-emea-002940-pip02-21_en.pdf"},
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    {"id":"57892","name":"P/0481/2021 : EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for marzeptacog alfa (activated) (EMEA-002270-PIP03-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-06T16:30:00Z","last_updated_date":"2023-03-06T16:30:00Z","reference_number":"EMA/632136/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0481-2021-ema-decision-3-december-2021-agreement-paediatric-investigation-plan-granting-deferral-marzeptacog-alfa-activated-emea-002270-pip03-20_en.pdf"},
    {"id":"57893","name":"P/0482/2021 : EMA decision of 3 December 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for marzeptacog alfa (activated) (EMEA-002270-PIP04-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-03-06T16:35:00Z","last_updated_date":"2023-03-06T16:35:00Z","reference_number":"EMA/632179/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0482-2021-ema-decision-3-december-2021-agreement-paediatric-investigation-plan-granting-deferral-marzeptacog-alfa-activated-emea-002270-pip04-20_en.pdf"},
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    {"id":"57734","name":"P/0444/2021: EMA decision of 22 November 2021 on the acceptance of a modification of an agreed paediatric investigation plan for single-stranded, 5’- capped messenger RNA (mRNA) ... (EMEA- 002893-PIP01-20-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-20T12:41:00Z","last_updated_date":"2023-02-20T12:41:00Z","reference_number":"EMA/532503/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0444-2021-ema-decision-22-november-2021-acceptance-modification-agreed-paediatric-investigation-plan-single-stranded-5-capped-messenger-rna-mrna-emea-002893-pip01-20-m01_en.pdf"},
    {"id":"57792","name":"P/0036/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tildacerfont (EMEA-002970-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-02-22T14:03:00Z","last_updated_date":"2023-02-22T14:03:00Z","reference_number":"EMA/9505/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tildacerfont-emea-002970-pip01-21_en.pdf"},
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    {"id":"57759","name":"P/0230/2022 : EMA decision of 8 July 2022 on the acceptance of a modification of an agreed paediatric investigation plan for delandistrogene moxeparvovec (EMEA-002677-PIP01-19-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-21T13:13:00Z","last_updated_date":"2023-02-21T13:13:00Z","reference_number":"EMA/575567/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2022-ema-decision-8-july-2022-acceptance-modification-agreed-paediatric-investigation-plan-delandistrogene-moxeparvovec-emea-002677-pip01-19-m02_en.pdf"},
    {"id":"57737","name":"P/0459/2021  EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Thienopyrimidine Derivative (EMEA-002901-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-02-20T15:10:00Z","last_updated_date":"2023-02-20T15:10:00Z","reference_number":"EMA/510195/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0459-2021-ema-decision-29-october-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-thienopyrimidine-derivative-emea-002901-pip01-20_en.pdf"},
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    {"id":"57669","name":"P/0454/2021 : EMA decision of of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adalimumab... (ABBV- 154) (EMEA-002927-PIP01-20)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T17:55:00Z","last_updated_date":"2023-02-14T17:55:00Z","reference_number":"EMA/532352/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0454-2021-ema-decision-29-october-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-adalimumab-abbv-154-emea-002927-pip01-20_en.pdf"},
    {"id":"57668","name":"P/0456/2021 : EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for respiratory syncytial virus (RSV)... (EMEA-002904-PIP01-20)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T17:27:00Z","last_updated_date":"2023-02-14T17:27:00Z","reference_number":"EMA/530441/2021 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0456-2021-ema-decision-29-october-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-respiratory-syncytial-virus-rsv-emea-002904-pip01-20_en.pdf"},
    {"id":"57667","name":"P/0457/2021 : EMA decision of 29 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for liveattenuated La Reunion strain of chikungunya virus (VLA1553) (EMEA-002873-PIP01-20)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T17:19:00Z","last_updated_date":"2023-02-14T17:19:00Z","reference_number":"EMA/582972/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0457-2021-ema-decision-29-october-2021-agreement-paediatric-investigation-plan-granting-deferral-liveattenuated-la-reunion-strain-chikungunya-virus-vla1553-emea-002873-pip01-20_en.pdf"},
    {"id":"57666","name":"P/0400/2021 : EMA decision of 1 October 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for loncastuximab tesirine (EMEA-002665-PIP02-20)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T17:08:00Z","last_updated_date":"2023-02-14T17:08:00Z","reference_number":"EMA/532643/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0400-2021-ema-decision-1-october-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-loncastuximab-tesirine-emea-002665-pip02-20_en.pdf"},
    {"id":"57659","name":"P/0021/2022 : EMA decision of 31 January 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral for poly(oxy-1,2- ethanediyl), alpha-hydro-omega-methoxy, ether with N-[[[2-[[6-[[1....(EMEA-002955-PIP01-21)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-14T11:48:00Z","last_updated_date":"2023-02-14T11:48:00Z","reference_number":"EMA/8320/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2022-ema-decision-31-january-2022-agreement-paediatric-investigation-plan-granting-deferral-polyoxy-12-ethanediyl-alpha-hydro-omega-methoxy-ether-n-2-6-1emea-002955-pip01-21_en.pdf"},
    {"id":"57647","name":"P/0470/2021: EMA decision of 26 November 2021 on the acceptance of a modification of an agreed paediatric investigation plan for risdiplam (Everysdi) (EMEA-002070-PIP01-16-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T15:10:00Z","last_updated_date":"2023-02-13T15:10:00Z","reference_number":"EMA/690024/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0470-2021-ema-decision-26-november-2021-acceptance-modification-agreed-paediatric-investigation-plan-risdiplam-everysdi-emea-002070-pip01-16-m06_en.pdf"},
    {"id":"57635","name":"P/0460/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for oteseconazole (EMEA-002392-PIP01-18-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T13:25:00Z","last_updated_date":"2023-02-13T13:25:00Z","reference_number":"EMA/532345/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0460-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-oteseconazole-emea-002392-pip01-18-m02_en.pdf"},
    {"id":"57617","name":"P/0449/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for galcanezumab (Emgality), (EMEA-001860-PIP03-16-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T12:03:00Z","last_updated_date":"2023-02-13T12:03:00Z","reference_number":"EMA/582624/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0449-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-galcanezumab-emgality-emea-001860-pip03-16-m06_en.pdf"},
    {"id":"57632","name":"P/0440/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for Abemaciclib (Verzenios), (EMEA-002342-PIP01-18-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T13:12:00Z","last_updated_date":"2023-02-13T13:12:00Z","reference_number":"EMA/533306/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0440-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-abemaciclib-verzenios-emea-002342-pip01-18-m02_en.pdf"},
    {"id":"57621","name":"P/0427/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for remimazolam (as besylate), (Byfavo), (EMEA-001880-PIP02-19-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T12:17:00Z","last_updated_date":"2023-02-13T12:17:00Z","reference_number":"EMA/550332/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0427-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-remimazolam-besylate-byfavo-emea-001880-pip02-19-m03_en.pdf"},
    {"id":"57628","name":"P/0426/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for palbociclib (Ibrance) (EMEA-002146-PIP01-17-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T12:40:00Z","last_updated_date":"2023-02-13T12:40:00Z","reference_number":"EMA/550398/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0426-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-palbociclib-ibrance-emea-002146-pip01-17-m03_en.pdf"},
    {"id":"57638","name":"P/0424/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for imatinib (as imatinib mesylate) (EMEA-002643-PIP01-19-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T13:40:00Z","last_updated_date":"2023-02-13T13:40:00Z","reference_number":"EMA/532461/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0424-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-imatinib-imatinib-mesylate-emea-002643-pip01-19-m01_en.pdf"},
    {"id":"57653","name":"P/0415/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ozanimod (hydrochloride) (Zeposia) (EMEA-001710-PIP02-14-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-02-13T15:49:00Z","last_updated_date":"2023-02-13T15:49:00Z","reference_number":"EMA/522035/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0415-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-ozanimod-hydrochloride-zeposia-emea-001710-pip02-14-m06_en.pdf"},
    {"id":"57630","name":"P/0416/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for elexacaftor / tezacaftor / ivacaftor (Kaftrio), (EMEA-002324-PIP01-17-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T12:57:00Z","last_updated_date":"2023-02-13T12:57:00Z","reference_number":"EMA/533018/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0416-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-elexacaftor-tezacaftor-ivacaftor-kaftrio-emea-002324-pip01-17-m02_en.pdf"},
    {"id":"57624","name":"P/0412/2021: EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for leriglitazone (EMEA-002106-PIP01-16-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T12:24:00Z","last_updated_date":"2023-02-13T12:24:00Z","reference_number":"EMA/550544/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0412-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-leriglitazone-emea-002106-pip01-16-m01_en.pdf"},
    {"id":"57615","name":"P/0408/2021: EMA decision of 8 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for acalabrutinib (Calquence) (EMEA-001796-PIP03-16-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T11:46:00Z","last_updated_date":"2023-02-13T11:46:00Z","reference_number":"EMA/554972/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0408-2021-ema-decision-8-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-acalabrutinib-calquence-emea-001796-pip03-16-m02_en.pdf"},
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    {"id":"57631","name":"P/0404/2021: EMA decision of 1 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ganaxolone ,(EMEA- 002341-PIP01-18-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2023-02-13T13:05:00Z","last_updated_date":"2023-02-13T13:05:00Z","reference_number":"EMA/533199/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0404-2021-ema-decision-1-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-ganaxolone-emea-002341-pip01-18-m02_en.pdf"},
    {"id":"57652","name":"P/0430/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fostemsavir (tromethamine) (EMEA-001687-PIP01-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-02-13T15:41:00Z","last_updated_date":"2023-02-13T15:41:00Z","reference_number":"EMA/522008/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0430-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-fostemsavir-tromethamine-emea-001687-pip01-14-m05_en.pdf"},
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    {"id":"57193","name":"P/0355/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ligelizumab (EMEA-001811-PIP04-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-01-10T10:44:00Z","last_updated_date":"2023-01-10T10:44:00Z","reference_number":"EMA/463911/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0355-2021-ema-decision-8-september-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ligelizumab-emea-001811-pip04-21_en.pdf"},
    {"id":"57191","name":"P/0372/2021 : EMA decision of 8 September 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ligelizumab (EMEA-001811-PIP03-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-01-09T16:39:00Z","last_updated_date":"2023-01-09T16:39:00Z","reference_number":"EMA/463911/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0372-2021-ema-decision-8-september-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ligelizumab-emea-001811-pip03-20_en.pdf"},
    {"id":"57189","name":"P/0384/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for atezolizumab (Tecentriq), (EMEA-001638-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-01-09T16:07:00Z","last_updated_date":"2023-01-09T16:07:00Z","reference_number":"EMA/440418/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0384-2021-ema-decision-8-september-2021-granting-product-specific-waiver-atezolizumab-tecentriq-emea-001638-pip02-21_en.pdf"},
    {"id":"57185","name":"P/0352/2021 : EMA decision of 8 September 2021 on the granting of a product specific waiver for florbetaben (18F) (Neuraceq), (EMEA-001090-PIP02- 21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-01-09T15:13:00Z","last_updated_date":"2023-01-09T15:13:00Z","reference_number":"EMA/470748/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0352-2021-ema-decision-8-september-2021-granting-product-specific-waiver-florbetaben-18f-neuraceq-emea-001090-pip02-21_en.pdf"},
    {"id":"57181","name":"P/0306/2021 : EMA decision of 14 September 2021 on the granting of a product specific waiver for empagliflozin (Jardiance), (EMEA-000828-PIP07-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-01-09T14:41:00Z","last_updated_date":"2023-01-09T14:41:00Z","reference_number":"EMA/517346/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0306-2021-ema-decision-14-september-2021-granting-product-specific-waiver-empagliflozin-jardiance-emea-000828-pip07-21_en.pdf"},
    {"id":"55923","name":"P/0308/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ligelizumab (EMEA-001811-PIP02-15-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T11:52:00Z","last_updated_date":"2022-09-01T11:52:00Z","reference_number":"EMA/393809/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-ligelizumab-emea-001811-pip02-15-m04_en.pdf"},
    {"id":"15926","name":"P/0120/2014: EMA decision of 7 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pradigastat (EMEA-001333-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-05T02:00:00Z","last_updated_date":"2014-06-05T02:00:00Z","reference_number":"EMA/195548/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2014-ema-decision-7-may-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pradigastat-emea-001333-pip02-13_en.pdf"},
    {"id":"54368","name":"P/0320/2021: EMA decision of 13 August 2021 on the agreement of a PIP and on the granting of a deferral & on the granting of a waiver for human, recombinant, non-fucosylated IgG1k monoclonal antibody targeting OX-40 receptor on activated T cells(KHK4083)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-03-07T17:26:00Z","last_updated_date":"2022-03-07T17:26:00Z","reference_number":"EMA/385417/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0320-2021-ema-decision-13-august-2021-agreement-pip-granting-deferral-granting-waiver-human-recombinant-non-fucosylated-igg1k-monoclonal-antibody-targeting-ox-40-receptor-activated-t-cellskhk4083_en.pdf"},
    {"id":"56095","name":"P/0127/2022 : EMA decision of 13 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abelacimab (EMEA-003017-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-14T11:39:00Z","last_updated_date":"2022-09-14T11:39:00Z","reference_number":"EMA/194423/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2022-ema-decision-13-april-2022-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-abelacimab-emea-003017-pip01-21_en.pdf"},
    {"id":"56092","name":"P/0326/2021 : EMA decision of 13 August 2021 on the granting of a product specific waiver for sivopixant (EMEA-003010-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-13T10:41:00Z","last_updated_date":"2022-09-13T10:41:00Z","reference_number":"EMA/384970/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0326-2021-ema-decision-13-august-2021-granting-product-specific-waiver-sivopixant-emea-003010-pip01-21_en.pdf"},
    {"id":"56091","name":"P/0288/2021 : EMA decision of 13 August 2021 on the granting of a product specific waiver for gemcitabine (hydrochloride) (EMEA-003007-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-13T10:35:00Z","last_updated_date":"2022-09-13T10:35:00Z","reference_number":"EMA/384852/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2021-ema-decision-13-august-2021-granting-product-specific-waiver-gemcitabine-hydrochloride-emea-003007-pip01-21_en.pdf"},
    {"id":"56090","name":"P/0289/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for cetrelimab (EMEA-003006-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-13T10:30:00Z","last_updated_date":"2022-09-13T10:30:00Z","reference_number":"EMA/418766/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0289-2021-ema-decision-11-august-2021-granting-product-specific-waiver-cetrelimab-emea-003006-pip01-21_en.pdf"},
    {"id":"56089","name":"P/0294/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for aldafermin (EMEA-003005-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-13T09:47:00Z","last_updated_date":"2022-09-13T09:47:00Z","reference_number":"EMA/418764/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2021-ema-decision-11-august-2021-granting-product-specific-waiver-aldafermin-emea-003005-pip01-21_en.pdf"},
    {"id":"56084","name":"EMA/427612/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for ramipril / amlodipine / hydrochlorothiazide (EMEA- 002998-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T16:46:00Z","last_updated_date":"2022-09-12T16:46:00Z","reference_number":"EMA/427612/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-427612-2021-ema-decision-11-august-2021-granting-product-specific-waiver-ramipril-amlodipine-hydrochlorothiazide-emea-002998-pip01-21_en.pdf"},
    {"id":"56076","name":"P/0299/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for immunoglobulin G1 anti-SORT1 human monoclonal antibody (EMEA-002997-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T16:35:00Z","last_updated_date":"2022-09-12T16:35:00Z","reference_number":"EMA/427613/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2021-ema-decision-11-august-2021-granting-product-specific-waiver-immunoglobulin-g1-anti-sort1-human-monoclonal-antibody-emea-002997-pip01-21_en.pdf"},
    {"id":"56070","name":"P/0335/2021 : EMA decision of 12 August 2021 on the granting of a product specific waiver for gabapentin (EMEA-002994-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T15:11:00Z","last_updated_date":"2022-09-12T15:11:00Z","reference_number":"EMA/382518/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0335-2021-ema-decision-12-august-2021-granting-product-specific-waiver-gabapentin-emea-002994-pip01-21_en.pdf"},
    {"id":"56069","name":"P/0312/2021 : EMA decision of 11 August 2021 on the granting of a product specific waiver for insulin icodec / semaglutide (EMEA-002988-PIP01-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T14:50:00Z","last_updated_date":"2022-09-12T14:50:00Z","reference_number":"EMA/434120/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0312-2021-ema-decision-11-august-2021-granting-product-specific-waiver-insulin-icodec-semaglutide-emea-002988-pip01-21_en.pdf"},
    {"id":"56067","name":"P/0344/2021 : EMA decision of 12 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for epcoritamab (EMEA-002907-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T14:00:00Z","last_updated_date":"2022-09-12T14:00:00Z","reference_number":"EMA/418671/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0344-2021-ema-decision-12-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-epcoritamab-emea-002907-pip01-20_en.pdf"},
    {"id":"56066","name":"P/0330/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for cefepime / zidebactam (EMEA-002892-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T13:25:00Z","last_updated_date":"2022-09-12T13:25:00Z","reference_number":"EMA/418666/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0330-2021-ema-decision-11-august-2021-agreement-paediatric-investigation-plan-granting-deferral-cefepime-zidebactam-emea-002892-pip01-20_en.pdf"},
    {"id":"56065","name":"P/0317/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ublituximab (EMEA-002889-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-12T12:35:00Z","last_updated_date":"2022-09-12T12:35:00Z","reference_number":"EMA/433846/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0317-2021-ema-decision-11-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ublituximab-emea-002889-pip02-20_en.pdf"},
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    {"id":"56045","name":"P/0300/2021: EMA decision of 13 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for cenobamate (EMEA-002563-PIP02-19-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2022-09-08T16:45:00Z","last_updated_date":"2022-09-08T16:45:00Z","reference_number":"EMA/386634/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2021-ema-decision-13-august-2021-agreement-paediatric-investigation-plan-granting-deferral-cenobamate-emea-002563-pip02-19-m01_en.pdf"},
    {"id":"56044","name":"P/0286/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lebrikizumab (EMEA-002536-PIP01-18-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2022-09-08T16:18:00Z","last_updated_date":"2022-09-08T16:18:00Z","reference_number":"EMA/386576/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0286-2021-ema-decision-11-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lebrikizumab-emea-002536-pip01-18-m01_en.pdf"},
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    {"id":"56042","name":"P/0346/2021 : EMA decision of 18 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pegylated-fibroblast growth factor 21 (BMS-986036) (EMEA-002488-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T15:52:00Z","last_updated_date":"2022-09-08T15:52:00Z","reference_number":"EMA/451036/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0346-2021-ema-decision-18-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-pegylated-fibroblast-growth-factor-21-bms-986036-emea-002488-pip01-18-m02_en.pdf"},
    {"id":"56041","name":"P/0321/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for allogeneic anti-CD19 CAR T cells produced using CRISPR/Cas9 to disrupt the T cell receptor....(EMEA-002881-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T15:43:00Z","last_updated_date":"2022-09-08T15:43:00Z","reference_number":"EMA/418665/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0321-2021-ema-decision-11-august-2021-agreement-paediatric-investigation-plan-granting-deferral-allogeneic-anti-cd19-car-t-cells-produced-using-crispr-cas9-disrupt-t-cell-receptoremea-002881-pip01_en.pdf"},
    {"id":"56040","name":"P/0323/2021 : EMA decision of 12 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for afamitresgene autoleucel (EMEA-002867-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T15:36:00Z","last_updated_date":"2022-09-08T15:36:00Z","reference_number":"EMA/382523/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0323-2021-ema-decision-12-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-afamitresgene-autoleucel-emea-002867-pip01-20_en.pdf"},
    {"id":"56038","name":"P/0290/2021 : EMA decision of 11 August 2021 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for bentracimab (EMEA-002766-PIP02-21)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T14:55:00Z","last_updated_date":"2022-09-08T14:55:00Z","reference_number":"EMA/434009/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0290-2021-ema-decision-11-august-2021-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-bentracimab-emea-002766-pip02-21_en.pdf"},
    {"id":"56039","name":"P/0324/2021 : EMA decision of 11 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl).....(EMEA-002863-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T15:20:00Z","last_updated_date":"2022-09-08T15:20:00Z","reference_number":"EMA/418664/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0324-2021-ema-decision-11-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-1r3s5r-2-2-3-acetyl-5-2-methylpyrimidin-5-ylemea-002863-pip01-20_en.pdf"},
    {"id":"56036","name":"P/0331/2021 : EMA decision of 13 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for infigratinib (EMEA-002594-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T14:31:00Z","last_updated_date":"2022-09-08T14:31:00Z","reference_number":"EMA/395885/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0331-2021-ema-decision-13-august-2021-agreement-paediatric-investigation-plan-granting-deferral-infigratinib-emea-002594-pip02-20_en.pdf"},
    {"id":"56031","name":"P/0319/2021 : EMA decision of 13 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fenebrutinib (EMEA-002349-PIP03-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T13:58:00Z","last_updated_date":"2022-09-08T13:58:00Z","reference_number":"EMA/385463/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0319-2021-ema-decision-13-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fenebrutinib-emea-002349-pip03-20_en.pdf"},
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    {"id":"56029","name":"P/0339/2021 : EMA decision of 9 August 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (Olumiant) (EMEA-001220-PIP08-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-08T13:32:00Z","last_updated_date":"2022-09-08T13:32:00Z","reference_number":"EMA/439290/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0339-2021-ema-decision-9-august-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-baricitinib-olumiant-emea-001220-pip08-20_en.pdf"},
    {"id":"56020","name":"P/0215/2022: EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tisagenlecleucel (Kymriah), (EMEA-001654-PIP01-14-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-07T17:16:00Z","last_updated_date":"2022-09-07T17:16:00Z","reference_number":"EMA/366055/2022","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2022-ema-decision-10-june-2022-acceptance-modification-agreed-paediatric-investigation-plan-tisagenlecleucel-kymriah-emea-001654-pip01-14-m04_en.pdf"},
    {"id":"55952","name":"P/0334/2021 : EMA decision of 19 August 2021 on acceptance of a modification of an agreed paediatric investigation plan for multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine (EMEA-002308-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-02T11:32:00Z","last_updated_date":"2022-09-02T11:32:00Z","reference_number":"EMA/382663/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0334-2021-ema-decision-19-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-multivalent-live-recombinant-non-replicating-human-cells-modified-vaccinia-ankara-vectored-vaccine_en.pdf"},
    {"id":"55951","name":"P/0307/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine....(EMEA-002307- PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-02T11:25:00Z","last_updated_date":"2022-09-02T11:25:00Z","reference_number":"EMA/382553/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2021-ema-decision-12-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-monovalent-live-recombinant-replication-incompetent-adenoviral-serotype-26-vectored-vaccineemea_en.pdf"},
    {"id":"55931","name":"P/0315/2021 : EMA decision of 12 August 2021 on the refusal of a modification of an agreed paediatric investigation plan and on the refusal of a deferral and on the granting of a product-specific waiver for in vitro....(EMEA-002217-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T15:31:00Z","last_updated_date":"2022-09-01T15:31:00Z","reference_number":"EMA/428127/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0315-2021-ema-decision-12-august-2021-refusal-modification-agreed-paediatric-investigation-plan-refusal-deferral-granting-product-specific-waiver-vitroemea-002217-pip01-17-m02_en.pdf"},
    {"id":"55930","name":"P/0343/2021 : EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide serotype......(EMEA-002215-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T15:21:00Z","last_updated_date":"2022-09-01T15:21:00Z","reference_number":"EMA/439333/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0343-2021-ema-decision-9-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-pneumococcal-polysaccharide-serotypeemea-002215-pip01-17-m03_en.pdf"},
    {"id":"55929","name":"P/0313/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for temelimab (EMEA- 002127-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T15:10:00Z","last_updated_date":"2022-09-01T15:10:00Z","reference_number":"EMA/427713/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0313-2021-ema-decision-12-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-temelimab-emea-002127-pip01-17-m01_en.pdf"},
    {"id":"55928","name":"P/0287/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for fasinumab (EMEA- 002059-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T15:03:00Z","last_updated_date":"2022-09-01T15:03:00Z","reference_number":"EMA/382537/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0287-2021-ema-decision-12-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-fasinumab-emea-002059-pip02-19-m01_en.pdf"},
    {"id":"55926","name":"EMA/382530/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo) (EMEA-002007-PIP02-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T12:22:00Z","last_updated_date":"2022-09-01T12:22:00Z","reference_number":"EMA/382530/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-382530-2021-ema-decision-12-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-cemiplimab-libtayo-emea-002007-pip02-17-m01_en.pdf"},
    {"id":"55925","name":"P/0292/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (EMEA-001900-PIP02-17-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T12:13:00Z","last_updated_date":"2022-09-01T12:13:00Z","reference_number":"EMA/393814/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0292-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-tralokinumab-emea-001900-pip02-17-m05_en.pdf"},
    {"id":"55924","name":"P/0314/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for lactobacillus reuteri (IBP-9414) (EMEA-001895-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T12:02:00Z","last_updated_date":"2022-09-01T12:02:00Z","reference_number":"EMA/393807/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0314-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-lactobacillus-reuteri-ibp-9414-emea-001895-pip01-15-m01_en.pdf"},
    {"id":"55921","name":"P/0296/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897) (EMEA-001784-PIP01-15-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T11:07:00Z","last_updated_date":"2022-09-01T11:07:00Z","reference_number":"EMA/434365/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0296-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-anti-respiratory-syncytial-virus-human-igg1k-monoclonal-antibody-medi8897-emea-001784-pip01-15-m03_en.pdf"},
    {"id":"55920","name":"P/0298/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for finerenone (EMEA-001623-PIP01-14-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T10:49:00Z","last_updated_date":"2022-09-01T10:49:00Z","reference_number":"EMA/434335/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-finerenone-emea-001623-pip01-14-m04_en.pdf"},
    {"id":"55919","name":"P/0341/2021 : EMA decision of 12 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for selumetinib (EMEA- 001585-PIP01-13-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T10:40:00Z","last_updated_date":"2022-09-01T10:40:00Z","reference_number":"EMA/438008/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0341-2021-ema-decision-12-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-selumetinib-emea-001585-pip01-13-m05_en.pdf"},
    {"id":"55918","name":"P/0329/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent) (EMEA-001501-PIP01-13-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T10:33:00Z","last_updated_date":"2022-09-01T10:33:00Z","reference_number":"EMA/434296/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0329-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-dupixent-emea-001501-pip01-13-m07_en.pdf"},
    {"id":"55917","name":"P/0336/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sirolimus (EMEA-001416-PIP01-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T10:20:00Z","last_updated_date":"2022-09-01T10:20:00Z","reference_number":"EMA/434139/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0336-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-sirolimus-emea-001416-pip01-12-m03_en.pdf"},
    {"id":"55916","name":"P/0337/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica) (EMEA-001397-PIP03-14-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T09:49:00Z","last_updated_date":"2022-09-01T09:49:00Z","reference_number":"EMA/432866/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0337-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-ibrutinib-imbruvica-emea-001397-pip03-14-m06_en.pdf"},
    {"id":"53799","name":"P/0340/2021: EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bumetanide (EMEA-001303-PIP01-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-18T14:51:00Z","last_updated_date":"2022-01-18T14:51:00Z","reference_number":"EMA/439409/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0340-2021-ema-decision-9-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-bumetanide-emea-001303-pip01-12-m04_en.pdf"},
    {"id":"55915","name":"P/0302/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for rurioctocog alfa pegol (ADYNOVI) (EMEA-001296-PIP01-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-09-01T09:30:00Z","last_updated_date":"2022-09-01T09:30:00Z","reference_number":"EMA/427607/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-rurioctocog-alfa-pegol-adynovi-emea-001296-pip01-12-m04_en.pdf"},
    {"id":"55914","name":"P/0311/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant) (EMEA-001220-PIP03-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T16:50:00Z","last_updated_date":"2022-08-31T16:50:00Z","reference_number":"EMA/427610/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0311-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-olumiant-emea-001220-pip03-16-m02_en.pdf"},
    {"id":"55913","name":"P/0316/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ferric maltol (Feraccru) (EMEA-001195-PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T16:43:00Z","last_updated_date":"2022-08-31T16:43:00Z","reference_number":"EMA/427611/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0316-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-ferric-maltol-feraccru-emea-001195-pip01-11-m05_en.pdf"},
    {"id":"55911","name":"P/0295/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for potassium (chloride) / magnesium (sulphate heptahydrate) / procaine (hydrochloride) / xylitol (EMEA-001171-PIP01-11- M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T15:51:00Z","last_updated_date":"2022-08-31T15:51:00Z","reference_number":"EMA/427604/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-potassium-chloride-magnesium-sulphate-heptahydrate-procaine-hydrochloride-xylitol-emea-001171-pip01_en.pdf"},
    {"id":"55910","name":"P/0304/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for hepatitis B (rDNA) surface antigen adjuvanted (HEPLISAV B) (EMEA-001127-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T15:36:00Z","last_updated_date":"2022-08-31T15:36:00Z","reference_number":"EMA/427608/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2021-ema-decision-11-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-hepatitis-b-rdna-surface-antigen-adjuvanted-heplisav-b-emea-001127-pip02-11-m01_en.pdf"},
    {"id":"55908","name":"P/0328/2021 : EMA decision of 13 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for selexipag (Uptravi) (EMEA-000997-PIP01-10-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T15:27:00Z","last_updated_date":"2022-08-31T15:27:00Z","reference_number":"EMA/395849/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0328-2021-ema-decision-13-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-selexipag-uptravi-emea-000997-pip01-10-m05_en.pdf"},
    {"id":"55907","name":"P/0342/2021 : EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine (Exparel) (EMEA-000877-PIP03-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T15:16:00Z","last_updated_date":"2022-08-31T15:16:00Z","reference_number":"EMA/439423/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0342-2021-ema-decision-9-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-bupivacaine-exparel-emea-000877-pip03-17-m03_en.pdf"},
    {"id":"55905","name":"P/0310/2021 : EMA decision of 13 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for vortioxetine (Brintellix) (EMEA-000455-PIP02-10-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T14:59:00Z","last_updated_date":"2022-08-31T14:59:00Z","reference_number":"EMA/395802/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2021-ema-decision-13-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-vortioxetine-brintellix-emea-000455-pip02-10-m08_en.pdf"},
    {"id":"55902","name":"P/0349/2021 : EMA decision of 20 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat) (EMEA-000402-PIP03-17-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T13:17:00Z","last_updated_date":"2022-08-31T13:17:00Z","reference_number":"EMA/439683/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0349-2021-ema-decision-20-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-lacosamide-vimpat-emea-000402-pip03-17-m05_en.pdf"},
    {"id":"55901","name":"P/0327/2021 : EMA decision of 13 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sacubitril / valsartan (Entresto) (EMEA-000316-PIP02-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-08-31T13:09:00Z","last_updated_date":"2022-08-31T13:09:00Z","reference_number":"EMA/395853/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0327-2021-ema-decision-13-august-2021-acceptance-modification-agreed-paediatric-investigation-plan-sacubitril-valsartan-entresto-emea-000316-pip02-11-m05_en.pdf"},
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    {"id":"54531","name":"P/0357/2021 : EMA decision of 8 September 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pevonedistat (EMEA- 002117-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-03-21T15:36:00Z","last_updated_date":"2022-03-21T15:36:00Z","reference_number":"EMA/470767/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0357-2021-ema-decision-8-september-2021-acceptance-modification-agreed-paediatric-investigation-plan-pevonedistat-emea-002117-pip01-17-m02_en.pdf"},
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    {"id":"54219","name":"P/0211/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dostarlimab, (EMEA- 002463-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-02-17T16:20:00Z","last_updated_date":"2022-02-17T16:20:00Z","reference_number":"EMA/218629/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2021-ema-decision-10-may-2021-acceptance-modification-agreed-paediatric-investigation-plan-dostarlimab-emea-002463-pip01-18-m01_en.pdf"},
    {"id":"54218","name":"P/0204/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cipaglucosidase alfa, (EMEA-002447-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-02-17T16:15:00Z","last_updated_date":"2022-02-17T16:15:00Z","reference_number":"EMA/217793/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2021-ema-decision-10-may-2021-acceptance-modification-agreed-paediatric-investigation-plan-cipaglucosidase-alfa-emea-002447-pip01-18-m01_en.pdf"},
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    {"id":"54215","name":"P/0185/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for isatuximab (Sarclisa), (EMEA-002205-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-02-17T15:35:00Z","last_updated_date":"2022-02-17T15:35:00Z","reference_number":"EMA/251319/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2021-ema-decision-10-may-2021-acceptance-modification-agreed-paediatric-investigation-plan-isatuximab-sarclisa-emea-002205-pip01-17-m02_en.pdf"},
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    {"id":"53821","name":"P/0178/2021: EMA decision of 19 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab (EMEA-002475-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-18T14:51:00Z","last_updated_date":"2022-01-18T14:51:00Z","reference_number":"EMA/212135/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2021-ema-decision-19-april-2021-acceptance-modification-agreed-paediatric-investigation-plan-spesolimab-emea-002475-pip02-19-m01_en.pdf"},
    {"id":"53820","name":"P/0148/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for valoctocogene roxaparvovec, (EMEA-002427-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-18T14:51:00Z","last_updated_date":"2022-01-18T14:51:00Z","reference_number":"EMA/152079/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2021-ema-decision-16-april-2021-acceptance-modification-agreed-paediatric-investigation-plan-valoctocogene-roxaparvovec-emea-002427-pip01-18-m01_en.pdf"},
    {"id":"53819","name":"P/0171/2021: EMA decision of 9 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for ganaxolone ,(EMEA- 002341-PIP01-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-18T14:51:00Z","last_updated_date":"2022-01-18T14:51:00Z","reference_number":"EMA/197408/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2021-ema-decision-9-april-2021-acceptance-modification-agreed-paediatric-investigation-plan-ganaxolone-emea-002341-pip01-18-m01_en.pdf"},
    {"id":"53818","name":"P/0169/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dienogest / ethinyl estradiol (EMEA-002229-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-18T14:51:00Z","last_updated_date":"2022-01-18T14:51:00Z","reference_number":"EMA/192380/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2021-ema-decision-14-april-2021-acceptance-modification-agreed-paediatric-investigation-plan-dienogest-ethinyl-estradiol-emea-002229-pip01-17-m02_en.pdf"},
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    {"id":"53812","name":"P/0151/2021: EMA decision of 16 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol, (EMEA- 001949-PIP02-18-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-18T14:51:00Z","last_updated_date":"2022-01-18T14:51:00Z","reference_number":"EMA/152075/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2021-ema-decision-16-april-2021-acceptance-modification-agreed-paediatric-investigation-plan-gadopiclenol-emea-001949-pip02-18-m01_en.pdf"},
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    {"id":"53732","name":"P/0143/2021: EMA decision of 14 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zilucoplan (EMEA-002747-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-14T12:07:00Z","last_updated_date":"2022-01-14T12:07:00Z","reference_number":"EMA/175350/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2021-ema-decision-14-april-2021-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-zilucoplan-emea-002747-pip01-20_en.pdf"},
    {"id":"40976","name":"P/0008/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pembrolizumab (Keytruda), (EMEA-001474-PIP02-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/28103/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-pembrolizumab-keytruda-emea-001474-pip02-16-m02_en.pdf"},
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    {"id":"53690","name":"P/0159/2021: EMA decision of 16 April 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for chikungunya Virus Virus-Like Particle Vaccine / aluminum hydroxide, (EMEA-002656-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2022-01-13T12:07:00Z","last_updated_date":"2022-01-13T12:07:00Z","reference_number":"EMA/152116/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2021-ema-decision-16-april-2021-agreement-paediatric-investigation-plan-granting-deferral-chikungunya-virus-virus-particle-vaccine-aluminum-hydroxide-emea-002656-pip01-19_en.pdf"},
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    {"id":"52583","name":"P/0463/2020 : EMA decision of 4 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for vonicog alfa (Veyvondi) (EMEA-001164-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T14:08:00Z","last_updated_date":"2021-09-23T14:08:00Z","reference_number":"EMA/622891/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0463-2020-ema-decision-4-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-vonicog-alfa-veyvondi-emea-001164-pip01-11-m04_en.pdf"},
    {"id":"52582","name":"P/0513/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for naloxegol (Moventig) (EMEA-001146-PIP01-11-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T14:03:00Z","last_updated_date":"2021-09-23T14:03:00Z","reference_number":"EMA/658136/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0513-2020-ema-decision-22-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-naloxegol-moventig-emea-001146-pip01-11-m06_en.pdf"},
    {"id":"52581","name":"P/0482/2020 : EMA decision of 9 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for avatrombopag (Doptelet) (EMEA-001136-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T13:56:00Z","last_updated_date":"2021-09-23T13:56:00Z","reference_number":"EMA/631901/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0482-2020-ema-decision-9-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-avatrombopag-doptelet-emea-001136-pip02-19-m01_en.pdf"},
    {"id":"52579","name":"P/0464/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana) (EMEA-001030-PIP01-10-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T11:31:00Z","last_updated_date":"2021-09-23T11:31:00Z","reference_number":"EMA/620966/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0464-2020-ema-decision-1-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-invokana-emea-001030-pip01-10-m08_en.pdf"},
    {"id":"52578","name":"P/0443/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia) (EMEA-000916-PIP01-10-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T11:26:00Z","last_updated_date":"2021-09-23T11:26:00Z","reference_number":"EMA/598855/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0443-2020-ema-decision-1-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-lixisenatide-lyxumia-emea-000916-pip01-10-m07_en.pdf"},
    {"id":"52577","name":"P/0514/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris) (EMEA-000876-PIP03-14-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T11:20:00Z","last_updated_date":"2021-09-23T11:20:00Z","reference_number":"EMA/598731/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0514-2020-ema-decision-22-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-eculizumab-soliris-emea-000876-pip03-14-m05_en.pdf"},
    {"id":"52576","name":"P/0494/2020 : EMA decision of 21 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (Cayston) (EMEA-000827-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T11:10:00Z","last_updated_date":"2021-09-23T11:10:00Z","reference_number":"EMA/631870/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0494-2020-ema-decision-21-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-aztreonam-cayston-emea-000827-pip01-09-m05_en.pdf"},
    {"id":"52575","name":"P/0469/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla) (EMEA-000715-PIP03-11-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T11:01:00Z","last_updated_date":"2021-09-23T11:01:00Z","reference_number":"EMA/620964/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0469-2020-ema-decision-1-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip03-11-m06_en.pdf"},
    {"id":"52574","name":"P/0465/2020 : EMA decision of 4 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for veliparib (EMEA- 000499-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T10:53:00Z","last_updated_date":"2021-09-23T10:53:00Z","reference_number":"EMA/622893/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0465-2020-ema-decision-4-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-veliparib-emea-000499-pip02-10-m01_en.pdf"},
    {"id":"52573","name":"P/0479/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for teduglutide (Revestive) (EMEA-000482-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T10:46:00Z","last_updated_date":"2021-09-23T10:46:00Z","reference_number":"EMA/627335/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0479-2020-ema-decision-1-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-teduglutide-revestive-emea-000482-pip01-08-m06_en.pdf"},
    {"id":"52570","name":"P/0466/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names) (EMEA-000347-PIP02-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T09:11:00Z","last_updated_date":"2021-09-23T09:11:00Z","reference_number":"EMA/576889/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0466-2020-ema-decision-1-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-associated-names-emea-000347-pip02-16-m02_en.pdf"},
    {"id":"52569","name":"P/0467/2020 : EMA decision of 1 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara) (EMEA-000311-PIP03-11-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T09:04:00Z","last_updated_date":"2021-09-23T09:04:00Z","reference_number":"EMA/576874/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0467-2020-ema-decision-1-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-ustekinumab-stelara-emea-000311-pip03-11-m06_en.pdf"},
    {"id":"52568","name":"P/0493/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ocrelizumab (Ocrevus) (EMEA-000310-PIP03-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T08:56:00Z","last_updated_date":"2021-09-23T08:56:00Z","reference_number":"EMA/598687/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0493-2020-ema-decision-22-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-ocrelizumab-ocrevus-emea-000310-pip03-10-m04_en.pdf"},
    {"id":"52565","name":"P/0516/2020 : EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag (Revolade) (EMEA-000170-PIP03-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-23T08:49:00Z","last_updated_date":"2021-09-23T08:49:00Z","reference_number":"EMA/633039/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0516-2020-ema-decision-22-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-eltrombopag-revolade-emea-000170-pip03-13-m04_en.pdf"},
    {"id":"52564","name":"P/0508/2020: EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for testosterone (EMEA-001529-PIP02-14-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T17:59:00Z","last_updated_date":"2021-09-22T17:59:00Z","reference_number":"EMA/633001/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0508-2020-ema-decision-22-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-testosterone-emea-001529-pip02-14-m03_en.pdf"},
    {"id":"52563","name":"P/0460/2020: EMA decision of 4 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant parathyroid hormone (Natpar), (EMEA-001526-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T17:54:00Z","last_updated_date":"2021-09-22T17:54:00Z","reference_number":"EMA/622890/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0460-2020-ema-decision-4-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-parathyroid-hormone-natpar-emea-001526-pip01-13-m04_en.pdf"},
    {"id":"52562","name":"P/0509/2020: EMA decision of 22 December 2020 on the acceptance of a modification of an agreed paediatric investigation plan for cholera vaccine, live attenuated, oral (strain CVD 103-HgR) (Vaxchora) (EMEA-001490-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T17:49:00Z","last_updated_date":"2021-09-22T17:49:00Z","reference_number":"EMA/628699/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0509-2020-ema-decision-22-december-2020-acceptance-modification-agreed-paediatric-investigation-plan-cholera-vaccine-live-attenuated-oral-strain-cvd-103-hgr-vaxchora-emea-001490-pip01-13-m02_en.pdf"},
    {"id":"52560","name":"P/0495/2020 : EMA decision of 22 December 2020 on the granting of a product specific waiver for tauroursodeoxycholic acid / sodium phenylbutyrate (EMEA-002876-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T15:52:00Z","last_updated_date":"2021-09-22T15:52:00Z","reference_number":"EMA/598775/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0495-2020-ema-decision-22-december-2020-granting-product-specific-waiver-tauroursodeoxycholic-acid-sodium-phenylbutyrate-emea-002876-pip01-20_en.pdf"},
    {"id":"52559","name":"P/0496/2020 : EMA decision of 22 December 2020 on the granting of a product specific waiver for tipifarnib (EMEA-002871-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T15:47:00Z","last_updated_date":"2021-09-22T15:47:00Z","reference_number":"EMA/653899/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0496-2020-ema-decision-22-december-2020-granting-product-specific-waiver-tipifarnib-emea-002871-pip01-20_en.pdf"},
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    {"id":"52557","name":"P/0485/2020 : EMA decision of 21 December 2020 on the granting of a product specific waiver for delolimogene mupadenorepvec (EMEA-002864-PIP01- 20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T15:23:00Z","last_updated_date":"2021-09-22T15:23:00Z","reference_number":"EMA/632005/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0485-2020-ema-decision-21-december-2020-granting-product-specific-waiver-delolimogene-mupadenorepvec-emea-002864-pip01-20_en.pdf"},
    {"id":"52556","name":"P/0497/2020 : EMA decision of 22 December 2020 on the granting of a product specific waiver for ramipril / bisoprolol (fumarate) (EMEA-002860-PIP01- 20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T15:17:00Z","last_updated_date":"2021-09-22T15:17:00Z","reference_number":"EMA/628688/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0497-2020-ema-decision-22-december-2020-granting-product-specific-waiver-ramipril-bisoprolol-fumarate-emea-002860-pip01-20_en.pdf"},
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    {"id":"52554","name":"P/0472/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for (1R,2R,3S,4S,5R,6S)-cyclohexane-1,2,3,4,5,6-hexaylhexakis (dihydrogen phosphate), (EMEA-002854-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T15:05:00Z","last_updated_date":"2021-09-22T15:05:00Z","reference_number":"EMA/627308/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0472-2020-ema-decision-1-december-2020-granting-product-specific-waiver-1r2r3s4s5r6s-cyclohexane-123456-hexaylhexakis-dihydrogen-phosphate-emea-002854-pip01-20_en.pdf"},
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    {"id":"52550","name":"P/0518/2020 : EMA decision of 21 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for adeno-associated viral vector serotype 9 containing the human mini-dystrophin gene.... (EMEA-002741-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T12:55:00Z","last_updated_date":"2021-09-22T12:55:00Z","reference_number":"EMA/581052/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0518-2020-ema-decision-21-december-2020-agreement-paediatric-investigation-plan-granting-deferral-adeno-associated-viral-vector-serotype-9-containing-human-mini-dystrophin-gene-emea-002741-pip01-20_en.pdf"},
    {"id":"52549","name":"P/0451/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for garadacimab (EMEA-002726-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T12:47:00Z","last_updated_date":"2021-09-22T12:47:00Z","reference_number":"EMA/621039/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0451-2020-ema-decision-1-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-garadacimab-emea-002726-pip01-19_en.pdf"},
    {"id":"52548","name":"P/0487/2020 : EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for etrasimod L-arginine (EMEA-002713-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T12:37:00Z","last_updated_date":"2021-09-22T12:37:00Z","reference_number":"EMA/598798/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0487-2020-ema-decision-22-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-etrasimod-l-arginine-emea-002713-pip01-19_en.pdf"},
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    {"id":"52542","name":"P/0473/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for BI 425809 (EMEA-002653-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T09:57:00Z","last_updated_date":"2021-09-22T09:57:00Z","reference_number":"EMA/627315/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0473-2020-ema-decision-1-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bi-425809-emea-002653-pip01-19_en.pdf"},
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    {"id":"52545","name":"P/0454/2020 : EMA decision of 4 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vonoprazan (EMEA-002703-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-22T11:18:00Z","last_updated_date":"2021-09-22T11:18:00Z","reference_number":"EMA/581093/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0454-2020-ema-decision-4-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vonoprazan-emea-002703-pip01-19_en.pdf"},
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    {"id":"52519","name":"P/0438/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for allogeneic B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (EMEA-002834-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T15:49:00Z","last_updated_date":"2021-09-20T15:49:00Z","reference_number":"EMA/599202/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0438-2020-ema-decision-1-december-2020-granting-product-specific-waiver-allogeneic-b-cell-maturation-antigen-bcma-directed-chimeric-antigen-receptor-t-cell-emea-002834-pip01-20_en.pdf"},
    {"id":"52518","name":"P/0499/2020 : EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for durlobactam / sulbactam (SUL-DUR) (EMEA-002807-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T15:43:00Z","last_updated_date":"2021-09-20T15:43:00Z","reference_number":"EMA/660371/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0499-2020-ema-decision-22-december-2020-agreement-paediatric-investigation-plan-granting-deferral-durlobactam-sulbactam-sul-dur-emea-002807-pip01-20_en.pdf"},
    {"id":"52517","name":"P/0449/2020 : EMA decision of 1 December 2020 on the granting of a product specific waiver for chimeric fibril-reactive IgG1k monoclonal antibody 11- 1F4 (EMEA-002791-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T15:37:00Z","last_updated_date":"2021-09-20T15:37:00Z","reference_number":"EMA/621027/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0449-2020-ema-decision-1-december-2020-granting-product-specific-waiver-chimeric-fibril-reactive-igg1k-monoclonal-antibody-11-1f4-emea-002791-pip01-20_en.pdf"},
    {"id":"52516","name":"P/0500/2020 : EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral...(EMEA-002763-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T15:27:00Z","last_updated_date":"2021-09-20T15:27:00Z","reference_number":"EMA/631923/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0500-2020-ema-decision-22-december-2020-agreement-paediatric-investigation-plan-granting-deferralemea-002763-pip01-20_en.pdf"},
    {"id":"52515","name":"P/0450/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for bispecific antibody binding to clotting factor IX and X (Mim8) (EMEA-002762-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T14:50:00Z","last_updated_date":"2021-09-20T14:50:00Z","reference_number":"EMA/599313/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0450-2020-ema-decision-1-december-2020-agreement-paediatric-investigation-plan-granting-deferral-bispecific-antibody-binding-clotting-factor-ix-x-mim8-emea-002762-pip02-20_en.pdf"},
    {"id":"52513","name":"P/0501/2020 : EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for olinciguat (EMEA-002759-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T14:45:00Z","last_updated_date":"2021-09-20T14:45:00Z","reference_number":"EMA/628660/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0501-2020-ema-decision-22-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-olinciguat-emea-002759-pip01-19_en.pdf"},
    {"id":"52512","name":"P/0486/2020: EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for fully human IgG1 RB-1 YTE anti-RSV F monoclonal antibody (MK-1654) (EMEA-002755-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-20T14:28:00Z","last_updated_date":"2021-09-20T14:28:00Z","reference_number":"EMA/598791/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0486-2020-ema-decision-22-december-2020-agreement-paediatric-investigation-plan-granting-waiver-fully-human-igg1-rb-1-yte-anti-rsv-f-monoclonal-antibody-mk-1654-emea-002755-pip01-19_en.pdf"},
    {"id":"52501","name":"P/0455/2020 : EMA decision of 4 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for cefepime / taniborbactam (EMEA-002576-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T14:15:00Z","last_updated_date":"2021-09-17T14:15:00Z","reference_number":"EMA/623412/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0455-2020-ema-decision-4-december-2020-agreement-paediatric-investigation-plan-granting-deferral-cefepime-taniborbactam-emea-002576-pip01-19_en.pdf"},
    {"id":"52498","name":"P/0474/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant human acid alpha-glucosidase (ATB200) (EMEA-002447-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T12:21:00Z","last_updated_date":"2021-09-17T12:21:00Z","reference_number":"EMA/627313/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0474-2020-ema-decision-1-december-2020-agreement-paediatric-investigation-plan-granting-deferral-recombinant-human-acid-alpha-glucosidase-atb200-emea-002447-pip01-18_en.pdf"},
    {"id":"52497","name":"P/0489/2020 : EMA decision of 21 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for voxelotor (EMEA-002356-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T12:10:00Z","last_updated_date":"2021-09-17T12:10:00Z","reference_number":"EMA/635386/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0489-2020-ema-decision-21-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-voxelotor-emea-002356-pip02-20_en.pdf"},
    {"id":"52495","name":"P/0490/2020 : EMA decision of 21 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for tabelecleucel (EMEA-002025-PIP04-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T11:58:00Z","last_updated_date":"2021-09-17T11:58:00Z","reference_number":"EMA/635370/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0490-2020-ema-decision-21-december-2020-agreement-paediatric-investigation-plan-granting-deferral-tabelecleucel-emea-002025-pip04-19_en.pdf"},
    {"id":"52494","name":"P/0476/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for lanadelumab (Takhzyro) (EMEA-001864-PIP03-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T11:46:00Z","last_updated_date":"2021-09-17T11:46:00Z","reference_number":"EMA/627311/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0476-2020-ema-decision-1-december-2020-agreement-paediatric-investigation-plan-granting-waiver-lanadelumab-takhzyro-emea-001864-pip03-19_en.pdf"},
    {"id":"52491","name":"P/0505/2020 : EMA decision of 22 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for venglustat (EMEA-001716-PIP05-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T11:15:00Z","last_updated_date":"2021-09-17T11:15:00Z","reference_number":"EMA/632794/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0505-2020-ema-decision-22-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-venglustat-emea-001716-pip05-20_en.pdf"},
    {"id":"52490","name":"P/0457/2020 : EMA decision of 4 December 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for venglustat (EMEA-001716-PIP04-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T11:07:00Z","last_updated_date":"2021-09-17T11:07:00Z","reference_number":"EMA/623415/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0457-2020-ema-decision-4-december-2020-agreement-paediatric-investigation-plan-granting-waiver-venglustat-emea-001716-pip04-19_en.pdf"},
    {"id":"52488","name":"P/0461/2020 : EMA decision of 4 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for guselkumab (Tremfya) (EMEA-001523-PIP04-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T10:46:00Z","last_updated_date":"2021-09-17T10:46:00Z","reference_number":"EMA/623328/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0461-2020-ema-decision-4-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-guselkumab-tremfya-emea-001523-pip04-19_en.pdf"},
    {"id":"52486","name":"P/0442/2020 : EMA decision of 1 December 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for alpha1-proteinase inhibitor (human) (EMEA-001312-PIP03-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-17T09:51:00Z","last_updated_date":"2021-09-17T09:51:00Z","reference_number":"EMA/599302/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0442-2020-ema-decision-1-december-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-alpha1-proteinase-inhibitor-human-emea-001312-pip03-19_en.pdf"},
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    {"id":"52397","name":"P/0434/2020 : EMA decision of 6 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for birch pollen extract (betula verrucosa) (ITULAZAX) (EMEA-001879-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T13:01:00Z","last_updated_date":"2021-09-09T13:01:00Z","reference_number":"EMA/576895/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0434-2020-ema-decision-6-november-2020-acceptance-modification-agreed-paediatric-investigation-plan-birch-pollen-extract-betula-verrucosa-itulazax-emea-001879-pip01-15-m02_en.pdf"},
    {"id":"52396","name":"P/0435/2020 : EMA decision of 13 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya) (EMEA-001460-PIP01-13-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T12:53:00Z","last_updated_date":"2021-09-09T12:53:00Z","reference_number":"EMA/593114/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0435-2020-ema-decision-13-november-2020-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-genvoya-emea-001460-pip01-13-m05_en.pdf"},
    {"id":"52394","name":"P/0432/2020 : EMA decision of 5 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo) (EMEA-001407-PIP01-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T12:42:00Z","last_updated_date":"2021-09-09T12:42:00Z","reference_number":"EMA/576787/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0432-2020-ema-decision-5-november-2020-acceptance-modification-agreed-paediatric-investigation-plan-nivolumab-opdivo-emea-001407-pip01-12-m03_en.pdf"},
    {"id":"52393","name":"P/0436/2020 : EMA decision of 13 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for ceftolozane / tazobactam (Zerbaxa) (EMEA-001142-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T12:35:00Z","last_updated_date":"2021-09-09T12:35:00Z","reference_number":"EMA/593110/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0436-2020-ema-decision-13-november-2020-acceptance-modification-agreed-paediatric-investigation-plan-ceftolozane-tazobactam-zerbaxa-emea-001142-pip01-11-m04_en.pdf"},
    {"id":"52392","name":"P/0437/2020 : EMA decision of 20 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil fumarate) (Viread) (EMEA-000533-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T12:29:00Z","last_updated_date":"2021-09-09T12:29:00Z","reference_number":"EMA/614606/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0437-2020-ema-decision-20-november-2020-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m09_en.pdf"},
    {"id":"52391","name":"P/0430/2020 : EMA decision of 5 November 2020 on the acceptance of a modification of an agreed paediatric investigation plan for concentrate of proteolytic enzyme enriched in bromelain (NexoBrid) (EMEA-000142-PIP02-09-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T12:19:00Z","last_updated_date":"2021-09-09T12:19:00Z","reference_number":"EMA/573811/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0430-2020-ema-decision-5-november-2020-acceptance-modification-agreed-paediatric-investigation-plan-concentrate-proteolytic-enzyme-enriched-bromelain-nexobrid-emea-000142-pip02-09-m10_en.pdf"},
    {"id":"52389","name":"P/0431/2020 : EMA decision of 5 November 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adrenaline (epinephrine) (EMEA-002749-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T10:56:00Z","last_updated_date":"2021-09-09T10:56:00Z","reference_number":"EMA/575492/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0431-2020-ema-decision-5-november-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-adrenaline-epinephrine-emea-002749-pip01-19_en.pdf"},
    {"id":"52388","name":"P/0398/2020 : EMA decision of 23 October 2020 on the granting of a product-specific waiver for sacituzumab govitecan (EMEA-002645-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-09-09T10:36:00Z","last_updated_date":"2021-09-09T10:36:00Z","reference_number":"EMA/494619/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0398-2020-ema-decision-23-october-2020-granting-product-specific-waiver-sacituzumab-govitecan-emea-002645-pip02-20_en.pdf"},
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    {"id":"51457","name":"P/0247/2020: EMA decision on the agreement of 15 July 2020 on the granting of a product specific waiver for sitagliptin (hydrochloride monohydrate) / metformin (hydrochloride) (EMEA-002732-PIP02-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-06-16T16:37:00Z","last_updated_date":"2021-06-16T16:37:00Z","reference_number":"EMA/362161/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2020-ema-decision-agreement-15-july-2020-granting-product-specific-waiver-sitagliptin-hydrochloride-monohydrate-metformin-hydrochloride-emea-002732-pip02-20_en.pdf"},
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    {"id":"50593","name":"P/0126/2021: EMA decision of 15 March 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) / matrix-M1","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2021-03-16T16:42:00Z","last_updated_date":"2021-03-16T16:42:00Z","reference_number":"EMA/152609/2021","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0126-2021-ema-decision-15-march-2021-agreement-paediatric-investigation-plan-granting-deferral-severe-acute-respiratory-syndrome-coronavirus-2-recombinant-spike-protein-nanoparticle-vaccine-sars-cov_en.pdf"},
    {"id":"44856","name":"P/0154/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ceftolozane / tazobactam (Zerbaxa), (EMEA-001142-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T18:00:00Z","last_updated_date":"2019-06-24T18:00:00Z","reference_number":"EMA/215034/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-ceftolozane-tazobactam-zerbaxa-emea-001142-pip01-11-m03_en.pdf"},
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    {"id":"8458","name":"P/95/2010: EMA decision of 2 June 2010on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto) (EMEA-000430-PIP01-08-M01) in accordance with Regula...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-01-25T00:09:00Z","last_updated_date":"2010-07-28T01:09:00Z","reference_number":"EMA/309268/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-95-2010-ema-decision-2-june-2010on-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m01-accordance-regula_en.pdf"},
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    {"id":"3219","name":"P/128/2011: EMA decision of 8 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for ipilimumab (EMEA-000117-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-13T02:00:00Z","last_updated_date":"2011-07-13T02:00:00Z","reference_number":"EMA/426558/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-128-2011-ema-decision-8-june-2011-agreement-paediatric-investigation-plan-granting-deferral-ipilimumab-emea-000117-pip02-10_en.pdf"},
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    {"id":"14477","name":"P/255/2009: EMA decision of 22 December 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for Allogeneic ex vivo expanded umbilical cord blood cells (EMA-000554...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-01-25T00:09:00Z","last_updated_date":"2010-01-25T00:09:00Z","reference_number":"EMA/811657/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-255-2009-ema-decision-22-december-2009-refusal-paediatric-investigation-plan-granting-waiver-allogeneic-ex-vivo-expanded-umbilical-cord-blood-cells-ema-000554_en.pdf"},
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    {"id":"50452","name":"P/0229/2020: of 17 June 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adeno-associated viral vector serotype 8 containing the human RPGR...(AAV8-RPGR) (EMEA-002601-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-03-05T13:50:00Z","last_updated_date":"2021-03-05T13:50:00Z","reference_number":"EMA/305290/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2020-17-june-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-adeno-associated-viral-vector-serotype-8-containing-human-rpgraav8-rpgr-emea-002601-pip01-19_en.pdf"},
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    {"id":"50435","name":"P/0212/2020: EMA decision of 16 June 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for gepotidacin (EMEA-002443-PIP02-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-03-05T12:16:00Z","last_updated_date":"2021-03-05T12:16:00Z","reference_number":"EMA/300041/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2020-ema-decision-16-june-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-gepotidacin-emea-002443-pip02-18_en.pdf"},
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    {"id":"48522","name":"P/0101/2020: EMA decision of 18 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole, (Noxafil), (EMEA-000468-PIP02-12-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T13:42:00Z","last_updated_date":"2020-07-31T13:42:00Z","reference_number":"EMA/124405/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2020-ema-decision-18-march-2020-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m06_en.pdf"},
    {"id":"48519","name":"P/0072/2020: EMA decision of 18 March 2020 on the acceptance of a modification of an agreed paediatric investigation plan for Perampanel (Fycompa) (EMEA-000467-PIP01-08-M13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T13:46:00Z","last_updated_date":"2020-07-31T13:46:00Z","reference_number":"EMA/82836/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2020-ema-decision-18-march-2020-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m13_en.pdf"},
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    {"id":"48499","name":"P/0110/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for verdiperstat (EMEA-002708-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T12:12:00Z","last_updated_date":"2020-07-31T12:12:00Z","reference_number":"EMA/124402/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2020-ema-decision-18-march-2020-granting-product-specific-waiver-verdiperstat-emea-002708-pip01-19_en.pdf"},
    {"id":"48498","name":"P/0118/2020: EMA decision of 27 March 2020 on the granting of a product specific waiver for eftilagimod alpha (EMEA-002698-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T12:12:00Z","last_updated_date":"2020-07-31T12:12:00Z","reference_number":"EMA/100930/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0118-2020-ema-decision-27-march-2020-granting-product-specific-waiver-eftilagimod-alpha-emea-002698-pip01-19_en.pdf"},
    {"id":"48497","name":"P/0067/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for Parsaclisib (EMEA-002696-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T12:12:00Z","last_updated_date":"2020-07-31T12:12:00Z","reference_number":"EMA/83522/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0067-2020-ema-decision-18-march-2020-granting-product-specific-waiver-parsaclisib-emea-002696-pip01-19_en.pdf"},
    {"id":"48496","name":"P/0090/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for zolbetuximab (EMEA-002695-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T12:12:00Z","last_updated_date":"2020-07-31T12:12:00Z","reference_number":"EMA/115515/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2020-ema-decision-18-march-2020-granting-product-specific-waiver-zolbetuximab-emea-002695-pip01-19_en.pdf"},
    {"id":"48495","name":"P/0112/2020: EMA decision of 20 March 2020 on the granting of a product specific waiver for brolucizumab (EMEA-002691-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-31T12:12:00Z","last_updated_date":"2020-07-31T12:12:00Z","reference_number":"EMA/100929/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2020-ema-decision-20-march-2020-granting-product-specific-waiver-brolucizumab-emea-002691-pip01-19_en.pdf"},
    {"id":"48494","name":"P/0091/2020: EMA decision of 18.03.20 on the granting of a product specific waiver for 6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4- methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3- d]pyrimidin-2(1H)-one","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-30T12:12:00Z","last_updated_date":"2020-07-30T12:12:00Z","reference_number":"EMA/115514/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2020-ema-decision-180320-granting-product-specific-waiver-6-fluoro-7-2-fluoro-6-hydroxyphenyl-1m-1-4-methyl-2-propan-2-ylpyridin-3-yl-4-2s-2-methyl-4-prop-2-enoylpiperazin-1-ylpyrido23_en.pdf"},
    {"id":"48493","name":"P/0068/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for Levodopa / Carbidopa (EMEA-002687-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-30T12:12:00Z","last_updated_date":"2020-07-30T12:12:00Z","reference_number":"EMA/83476/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2020-ema-decision-18-march-2020-granting-product-specific-waiver-levodopa-carbidopa-emea-002687-pip01-19_en.pdf"},
    {"id":"48492","name":"P/0113/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for (2S)-2-[[2-[(4S)-4-(difluoromethyl)-2-oxo-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide (EMEA-002686-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-30T12:12:00Z","last_updated_date":"2020-07-30T12:12:00Z","reference_number":"EMA/124396/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2020-ema-decision-18-march-2020-granting-product-specific-waiver-2s-2-2-4s-4-difluoromethyl-2-oxo-oxazolidin-3-yl-56-dihydroimidazo12-d14benzoxazepin-9-ylaminopropanamide-emea-002686-pip01-19_en.pdf"},
    {"id":"48491","name":"P/0077/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract (EMEA-002668-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-30T12:12:00Z","last_updated_date":"2020-07-30T12:12:00Z","reference_number":"EMA/83650/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2020-ema-decision-18-march-2020-granting-product-specific-waiver-5-d9-tetrahydrocannabinol-standardised-cannabis-extract-emea-002668-pip01-19_en.pdf"},
    {"id":"48490","name":"P/0094/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant anti-human CD20 and anti-human CD3 monoclonal antibody(RO7082859;CD20 CD3 TCB)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-30T12:12:00Z","last_updated_date":"2020-07-30T12:12:00Z","reference_number":"EMA/115521/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2020-ema-decision-18-march-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-anti-human-cd20-anti-human-cd3-monoclonal-antibodyro7082859cd20-cd3-tcb_en.pdf"},
    {"id":"48479","name":"P/0073/2020: EMA decision of 21 March 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for zoliflodacin (EMEA-002599-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-29T11:53:00Z","last_updated_date":"2020-07-29T11:53:00Z","reference_number":"EMA/83593/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2020-ema-decision-21-march-2020-agreement-paediatric-investigation-plan-granting-waiver-zoliflodacin-emea-002599-pip01-19_en.pdf"},
    {"id":"48478","name":"P/0097/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for efgartigimod alfa (EMEA-002597-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-29T11:53:00Z","last_updated_date":"2020-07-29T11:53:00Z","reference_number":"EMA/76622/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2020-ema-decision-18-march-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-efgartigimod-alfa-emea-002597-pip01-19_en.pdf"},
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    {"id":"48473","name":"P/0117/2020: EMA decision of 18 March 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-neonatal Fc receptor human monoclonal antibody(EMEA-002559-PIP02-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-29T11:53:00Z","last_updated_date":"2020-07-29T11:53:00Z","reference_number":"EMA/124386/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0117-2020-ema-decision-18-march-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-neonatal-fc-receptor-human-monoclonal-antibodyemea-002559-pip02-19_en.pdf"},
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    {"id":"48471","name":"P/0122/2020: EMA decision of 18 March 2020 on the granting of a product specific waiver for 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea (EMEA-002526-PIP02-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-07-29T11:53:00Z","last_updated_date":"2020-07-29T11:53:00Z","reference_number":"EMA/130405/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2020-ema-decision-18-march-2020-granting-product-specific-waiver-1-4-bromo-5-1-ethyl-7-methylamino-2-oxo-12-dihydro-16-naphthyridin-3-yl-2-fluorophenyl-3-phenylurea-emea-002526-pip02-19_en.pdf"},
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    {"id":"47997","name":"P/0064/2020: EMA decision of 20 February 2020 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-12T11:57:00Z","last_updated_date":"2020-06-12T11:57:00Z","reference_number":"EMA/79374/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2020-ema-decision-20-february-2020-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigens-equivalent-h1n1-strain-h3n2-strain-b_en.pdf"},
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    {"id":"47994","name":"P/0030/2020: EMA decision of 29 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for (RS)-baclofen / Naltrexone HCl / D-Sorbitol (PXT3003) (EMEA-002164-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-12T11:57:00Z","last_updated_date":"2020-06-12T11:57:00Z","reference_number":"EMA/12127/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2020-ema-decision-29-january-2020-acceptance-modification-agreed-paediatric-investigation-plan-rs-baclofen-naltrexone-hcl-d-sorbitol-pxt3003-emea-002164-pip01-17-m02_en.pdf"},
    {"id":"47993","name":"P/0058/2020: EMA decision of 14 February 2020 on the refusal of a modification of an agreed paediatric investigation plan for fluticasone furoate / umeclidinium bromide / vilanterol trifenatate (Trelegy Ellipta / Elebrato Ellipta / Temybric Ellipta)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-12T11:57:00Z","last_updated_date":"2020-06-12T11:57:00Z","reference_number":"EMA/27242/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2020-ema-decision-14-february-2020-refusal-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-umeclidinium-bromide-vilanterol-trifenatate-trelegy-ellipta-elebrato-ellipta_en.pdf"},
    {"id":"47992","name":"P/0004/2020: EMA decision of 6 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for lumasiran (ALN-GO1) (EMEA-002079-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-12T11:57:00Z","last_updated_date":"2020-06-12T11:57:00Z","reference_number":"EMA/658963/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2020-ema-decision-6-january-2020-acceptance-modification-agreed-paediatric-investigation-plan-lumasiran-aln-go1-emea-002079-pip01-16-m01_en.pdf"},
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    {"id":"47990","name":"P/0047/2020: EMA decision of 29 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for cannabidiol (CBD) (EMEA-001964-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-12T11:57:00Z","last_updated_date":"2020-06-12T11:57:00Z","reference_number":"EMA/22234/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0047-2020-ema-decision-29-january-2020-acceptance-modification-agreed-paediatric-investigation-plan-cannabidiol-cbd-emea-001964-pip01-16-m01_en.pdf"},
    {"id":"47989","name":"P/0006/2020: EMA decision of 6 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / velpatasvir / voxilaprevir (Vosevi), (EMEA-001822-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-12T11:57:00Z","last_updated_date":"2020-06-12T11:57:00Z","reference_number":"EMA/658961/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2020-ema-decision-6-january-2020-acceptance-modification-agreed-paediatric-investigation-plan-sofosbuvir-velpatasvir-voxilaprevir-vosevi-emea-001822-pip01-15-m01_en.pdf"},
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    {"id":"47937","name":"P/0038/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for 3-[4-(4-Aminopiperidin-1-yl)-3-(3,5- difluorophenyl)quinolin-6-yl]-2-hydroxybenzonitrile (CRN00808) (EMEA-002682-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/23328/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0038-2020-ema-decision-29-january-2020-granting-product-specific-waiver-3-4-4-aminopiperidin-1-yl-3-35-difluorophenylquinolin-6-yl-2-hydroxybenzonitrile-crn00808-emea-002682-pip01-19_en.pdf"},
    {"id":"47936","name":"P/0039/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for autologous dendritic cells activated by transient exposure to killed prostate cancer cells ex vivo (DCVAC/PCa) (EMEA-002679-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/23326/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2020-ema-decision-29-january-2020-granting-product-specific-waiver-autologous-dendritic-cells-activated-transient-exposure-killed-prostate-cancer-cells-ex-vivo-dcvac-pca-emea-002679-pip01-19_en.pdf"},
    {"id":"47935","name":"P/0040/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for physostigmine / hyoscine (EMEA-002678-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/12863/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2020-ema-decision-29-january-2020-granting-product-specific-waiver-physostigmine-hyoscine-emea-002678-pip01-19_en.pdf"},
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    {"id":"47933","name":"P/0016/2020: EMA decision of 6 January 2020 on the granting of a product specific waiver for ethanol (EMEA-002672-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/659448/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2020-ema-decision-6-january-2020-granting-product-specific-waiver-ethanol-emea-002672-pip01-19_en.pdf"},
    {"id":"47932","name":"P/0041/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for modified human papillomavirus capsid protein conjugated to the near-infrared dye silicate(5-),bis[N-[3-[(hydroxy-.kappa.O)dimethylsilyl]propyl]-3- sulfo-N,N-b...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/26709/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0041-2020-ema-decision-29-january-2020-granting-product-specific-waiver-modified-human-papillomavirus-capsid-protein-conjugated-near-infrared-dye-silicate5-bisn-3-hydroxy-kappaodimethylsilylpropyl-3_en.pdf"},
    {"id":"47931","name":"P/0042/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for rhPSMA-7.3 (18F) (EMEA-002657-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/26708/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2020-ema-decision-29-january-2020-granting-product-specific-waiver-rhpsma-73-18f-emea-002657-pip01-19_en.pdf"},
    {"id":"47930","name":"P/0035/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for benzocaine (EMEA-002654-PIP02-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/28562/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0035-2020-ema-decision-29-january-2020-granting-product-specific-waiver-benzocaine-emea-002654-pip02-19_en.pdf"},
    {"id":"47929","name":"P/0043/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for glibenclamide (EMEA-002651-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/12840/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2020-ema-decision-29-january-2020-granting-product-specific-waiver-glibenclamide-emea-002651-pip01-19_en.pdf"},
    {"id":"47928","name":"P/0044/2020: EMA decision of 29.01.2020 on the granting of a product specific waiver for humanized immunoglobulin (Ig) G4 proline, alanine, alanine (IgG4 PAA) based bispecific antibody directed against cluster of differentiation (CD) 3 receptor complex..","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/27231/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2020-ema-decision-29012020-granting-product-specific-waiver-humanized-immunoglobulin-ig-g4-proline-alanine-alanine-igg4-paa-based-bispecific-antibody-directed-against-cluster-differentiation-cd_en.pdf"},
    {"id":"47927","name":"P/0045/2020: EMA decision of 29 January 2020 on the granting of a product specific waiver for futibatinib (EMEA-002647-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/26705/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2020-ema-decision-29-january-2020-granting-product-specific-waiver-futibatinib-emea-002647-pip01-19_en.pdf"},
    {"id":"47921","name":"P/0056/2020: EMA decision of 10 February 2020 on the granting of a product specific waiver for levocetirizine / montelukast (EMEA-002646-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/28566/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0056-2020-ema-decision-10-february-2020-granting-product-specific-waiver-levocetirizine-montelukast-emea-002646-pip01-19_en.pdf"},
    {"id":"47920","name":"P/0018/2020: EMA decision of 6 January 2020 on the granting of a product specific waiver for sacituzumab govitecan (EMEA-002645-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/672902/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2020-ema-decision-6-january-2020-granting-product-specific-waiver-sacituzumab-govitecan-emea-002645-pip01-19_en.pdf"},
    {"id":"47919","name":"P/0019/2020: EMA decision of 3 January 2020 on the granting of a product specific waiver for iberdomide (EMEA-002636-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/671589/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2020-ema-decision-3-january-2020-granting-product-specific-waiver-iberdomide-emea-002636-pip01-19_en.pdf"},
    {"id":"47918","name":"P/0015/2020: EMA decision of 6 January 2020 on the granting of a product specific waiver for bispecific T-cell engager antibody with a single-chain fragment crystallizable moiety that binds to B cell maturation antigen surface receptor on tumour cells...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/672673/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2020-ema-decision-6-january-2020-granting-product-specific-waiver-bispecific-t-cell-engager-antibody-single-chain-fragment-crystallizable-moiety-binds-b-cell-maturation-antigen-surface-receptor_en.pdf"},
    {"id":"47917","name":"P/0057/2020: EMA decision of 11 February 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-IL-17A/F nanobody (MK 1095) (EMEA-002568-PIP01-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/12614/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2020-ema-decision-11-february-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-il-17a-f-nanobody-mk-1095-emea-002568-pip01-19_en.pdf"},
    {"id":"47916","name":"P/0055/2020: EMA decision of 10 February 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human immunoglobulin G2 isotype antibody to IL-33R (EMEA-002515-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/26711/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2020-ema-decision-10-february-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-immunoglobulin-g2-isotype-antibody-il-33r-emea-002515-pip01-18_en.pdf"},
    {"id":"47915","name":"P/0048/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan for factor VIII Fc – von Willebrand factor – XTEN fusion protein (rFVIIIFc-VWF-XTEN) (EMEA-002501-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/23626/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0048-2020-ema-decision-29-january-2020-agreement-paediatric-investigation-plan-factor-viii-fc-von-willebrand-factor-xten-fusion-protein-rfviiifc-vwf-xten-emea-002501-pip01-18_en.pdf"},
    {"id":"47914","name":"P/0049/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for budesonide (EMEA-002500-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/27396/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2020-ema-decision-29-january-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-budesonide-emea-002500-pip01-18_en.pdf"},
    {"id":"47913","name":"P/0050/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for norursodeoxycholic acid (EMEA-002485-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/12617/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2020-ema-decision-29-january-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-norursodeoxycholic-acid-emea-002485-pip01-18_en.pdf"},
    {"id":"47912","name":"P/0051/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2-[[8-chloro-3-[(4-chlorophenyl)methyl]-4-(difluoromethoxy)-2-ethyl-5- quinolinyl]oxy]..","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-10T14:00:00Z","last_updated_date":"2020-06-10T14:00:00Z","reference_number":"EMA/26710/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0051-2020-ema-decision-29-january-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2-8-chloro-3-4-chlorophenylmethyl-4-difluoromethoxy-2-ethyl-5-quinolinyloxy_en.pdf"},
    {"id":"47911","name":"P/0061/2020: EMA decision of 10 February 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for berotralstat, (EMEA-002449-PIP02-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-09T14:00:00Z","last_updated_date":"2020-06-09T14:00:00Z","reference_number":"EMA/67983/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0061-2020-ema-decision-10-february-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-berotralstat-emea-002449-pip02-18_en.pdf"},
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    {"id":"47909","name":"P/0021/2020: EMA decision of 6 January 2020 on the agreement of a paediatric investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP02-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-09T14:00:00Z","last_updated_date":"2020-06-09T14:00:00Z","reference_number":"EMA/659463/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2020-ema-decision-6-january-2020-agreement-paediatric-investigation-plan-abemaciclib-verzenios-emea-002342-pip02-18_en.pdf"},
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    {"id":"47907","name":"P/0053/2020: EMA decision of 29 January 2020 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for anti-CD7 mAb conjugated to ricin toxin A chain / anti-CD3 mAb conjugated to ricin toxin A chain (T-Guard)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-09T14:00:00Z","last_updated_date":"2020-06-09T14:00:00Z","reference_number":"EMA/12468/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2020-ema-decision-29-january-2020-agreement-pip-granting-deferral-granting-waiver-anti-cd7-mab-conjugated-ricin-toxin-chain-anti-cd3-mab-conjugated-ricin-toxin-chain-t-guard_en.pdf"},
    {"id":"47906","name":"P/0059/2020: EMA decision of 10 February 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP04-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-09T14:00:00Z","last_updated_date":"2020-06-09T14:00:00Z","reference_number":"EMA/65322/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2020-ema-decision-10-february-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dupilumab-dupixent-emea-001501-pip04-19_en.pdf"},
    {"id":"47905","name":"P/0001/2020: EMA decision of 3 January 2020 on the granting of a product specific waiver for masitinib (mesylate) (EMEA-001266-PIP04-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-09T14:00:00Z","last_updated_date":"2020-06-09T14:00:00Z","reference_number":"EMA/671590/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2020-ema-decision-3-january-2020-granting-product-specific-waiver-masitinib-mesylate-emea-001266-pip04-19_en.pdf"},
    {"id":"47902","name":"P/0046/2020: EMA decision of 29 January 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atogepant (EMEA-002530-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-09T16:35:00Z","last_updated_date":"2020-06-09T16:35:00Z","reference_number":"EMA/28876/2020 ","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2020-ema-decision-29-january-2020-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-atogepant-emea-002530-pip01-18_en.pdf"},
    {"id":"47886","name":"P/0201/2020: EMA decision of 19 May 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral for remdesivir (EMEA-002826-PIP01-20)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-08T14:00:00Z","last_updated_date":"2020-06-08T14:00:00Z","reference_number":"EMA/269449/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2020-ema-decision-19-may-2020-agreement-paediatric-investigation-plan-granting-deferral-remdesivir-emea-002826-pip01-20_en.pdf"},
    {"id":"47869","name":"P/0009/2020: EMA decision of 6 January 2020 on the refusal of a product specific waiver for chloroprocaine (hydrochloride) (Ampres) (EMEA-000639-PIP05-19)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-04T01:00:00Z","last_updated_date":"2020-06-04T01:00:00Z","reference_number":"EMA/672154/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2020-ema-decision-6-january-2020-refusal-product-specific-waiver-chloroprocaine-hydrochloride-ampres-emea-000639-pip05-19_en.pdf"},
    {"id":"47866","name":"P/0066/2020: EMA decision of 28 February 2020 on the agreement of a paediatric investigation plan and on the granting of a waiver for mecasermin rinfabate (EMEA-000534-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2020-06-04T01:00:00Z","last_updated_date":"2020-06-04T01:00:00Z","reference_number":"EMA/86893/2020","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2020-ema-decision-28-february-2020-agreement-paediatric-investigation-plan-granting-waiver-mecasermin-rinfabate-emea-000534-pip03-17_en.pdf"},
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    {"id":"30557","name":"P/0246/2012: EMA decision of 22 October 2012 on the granting of a product-specific waiver for perindopril (tosilate) / amlodipine (besilate) (EMEA-001320-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/636961/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2012-ema-decision-22-october-2012-granting-product-specific-waiver-perindopril-tosilate-amlodipine-besilate-emea-001320-pip01-12_en.pdf"},
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    {"id":"45950","name":"P/0234/2019: EMA decision of 16 June 2019 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/369846/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2019-ema-decision-16-june-2019-agreement-pip-granting-deferral-granting-waiver-autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-encoding-human-ba-t87q-globin-gene_en.pdf"},
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    {"id":"45933","name":"P/0219/2019: EMA decision of 17 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Influenza Hemagglutinin-strain A (H1N1 and H3N2 subtypes) and strain-B (Victoria lineage and Yamagata lineage)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/324014/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2019-ema-decision-17-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-influenza-hemagglutinin-strain-h1n1-h3n2-subtypes-strain-b-victoria-lineage-yamagata_en.pdf"},
    {"id":"45932","name":"P/0206/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for daratumumab (Darzalex) (EMEA-002152-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/289405/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-daratumumab-darzalex-emea-002152-pip01-17-m01_en.pdf"},
    {"id":"45931","name":"P/0203/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for palbociclib (IBRANCE), (EMEA-002146-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/287173/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-palbociclib-ibrance-emea-002146-pip01-17-m01_en.pdf"},
    {"id":"45930","name":"P/0198/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor (JCAR017) (EMEA-001995-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/640003/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd4-cd8-t-cells-expressing-cd19-specific-chimeric-antigen-receptor-jcar017-emea-001995_en.pdf"},
    {"id":"45929","name":"P/0199/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (ALXN1210) (EMEA-001943-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/287178/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-ravulizumab-alxn1210-emea-001943-pip01-16-m02_en.pdf"},
    {"id":"45928","name":"P/0207/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for atezolizumab (Tecentriq), (EMEA-001638-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/287009/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-atezolizumab-tecentriq-emea-001638-pip01-14-m02_en.pdf"},
    {"id":"45927","name":"P/0220/2019: EMA decision of 17 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for humanised anti-IL-6 receptor (IL-6R) monoclonal antibody (EMEA-001625-PIP01-14-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/327378/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2019-ema-decision-17-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-humanised-anti-il-6-receptor-il-6r-monoclonal-antibody-emea-001625-pip01-14-m03_en.pdf"},
    {"id":"45926","name":"P/0197/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for semaglutide (EMEA-001441-PIP02-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/289393/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-semaglutide-emea-001441-pip02-15-m02_en.pdf"},
    {"id":"45925","name":"P/0201/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica), (EMEA-001397-PIP03-14-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/275965/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-ibrutinib-imbruvica-emea-001397-pip03-14-m04_en.pdf"},
    {"id":"45924","name":"P/0204/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for obeticholic acid (Ocaliva), (EMEA-001304-PIP02-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/287170/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-obeticholic-acid-ocaliva-emea-001304-pip02-13-m04_en.pdf"},
    {"id":"45923","name":"P/0221/2019: EMA decision of 17 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for terbinafine (hydrochloride) (EMEA-001259-PIP02-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/327869/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2019-ema-decision-17-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-terbinafine-hydrochloride-emea-001259-pip02-13-m02_en.pdf"},
    {"id":"45922","name":"P/0209/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (LENVIMA, Kisplyx), (EMEA-001119-PIP02-12-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/275963/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2019-ema-decision-12-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-lenvatinib-lenvima-kisplyx-emea-001119-pip02-12-m05_en.pdf"},
    {"id":"45921","name":"P/0223/2019: EMA decision of 21 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-08T10:01:00Z","last_updated_date":"2019-11-08T10:01:00Z","reference_number":"EMA/338825/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2019-ema-decision-21-june-2019-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m05_en.pdf"},
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    {"id":"45915","name":"P/0214/2019: EMA decision of 12 June 2019 on the granting of a product specific waiver for capivasertib (EMEA-002551-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-07T10:01:00Z","last_updated_date":"2019-11-07T10:01:00Z","reference_number":"EMA/289392/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2019-ema-decision-12-june-2019-granting-product-specific-waiver-capivasertib-emea-002551-pip01-18_en.pdf"},
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    {"id":"45906","name":"P/0218/2019: EMA decision of 17 June 2019 on the agreement of a PIP and on the granting of a deferral for adeno-associated viral vector serotype 5 containing a B domain deleted variant of human coagulation factor VIII gene (BMN 270) (EMEA-002427-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-07T10:01:00Z","last_updated_date":"2019-11-07T10:01:00Z","reference_number":"EMA/275986/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2019-ema-decision-17-june-2019-agreement-pip-granting-deferral-adeno-associated-viral-vector-serotype-5-containing-b-domain-deleted-variant-human-coagulation-factor-viii-gene-bmn-270-emea_en.pdf"},
    {"id":"45905","name":"P/0210/2019: EMA decision of 12 June 2019 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for dexamethasone (EMEA-002423-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-11-07T10:01:00Z","last_updated_date":"2019-11-07T10:01:00Z","reference_number":"EMA/288637/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2019-ema-decision-12-june-2019-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-dexamethasone-emea-002423-pip01-18_en.pdf"},
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    {"id":"44835","name":"P/0141/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for ertugliflozin (Steglatro), (EMEA-001533-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T16:39:00Z","last_updated_date":"2019-06-24T16:39:00Z","reference_number":"EMA/215044/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-ertugliflozin-steglatro-emea-001533-pip01-13-m02_en.pdf"},
    {"id":"44834","name":"P/0094/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for molgramostim (EMEA-002282-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T16:30:00Z","last_updated_date":"2019-06-24T16:30:00Z","reference_number":"EMA/130699/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-molgramostim-emea-002282-pip01-17_en.pdf"},
    {"id":"44833","name":"P/0136/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant parathyroid hormone (Natpar), (EMEA-001526-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T16:30:00Z","last_updated_date":"2019-06-24T16:30:00Z","reference_number":"EMA/190115/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-parathyroid-hormone-natpar-emea-001526-pip01-13-m03_en.pdf"},
    {"id":"44832","name":"P/0130/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (EMEA- 001521-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T16:23:00Z","last_updated_date":"2019-06-24T16:23:00Z","reference_number":"EMA/190114/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-luspatercept-emea-001521-pip01-13-m03_en.pdf"},
    {"id":"44831","name":"P/0151/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for idarucizumab (Praxbind), (EMEA-001438-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T16:16:00Z","last_updated_date":"2019-06-24T16:16:00Z","reference_number":"EMA/215040/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-idarucizumab-praxbind-emea-001438-pip01-13-m01_en.pdf"},
    {"id":"44830","name":"P/0157/2019: EMA decision of 17 April 2019 on the refusal of a modification of an agreed paediatric investigation plan for fevipiprant (EMEA-001315-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T16:03:00Z","last_updated_date":"2019-06-24T16:03:00Z","reference_number":"EMA/215887/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2019-ema-decision-17-april-2019-refusal-modification-agreed-paediatric-investigation-plan-fevipiprant-emea-001315-pip02-16-m01_en.pdf"},
    {"id":"44829","name":"P/0152/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for voclosporin (EMEA-002264-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T15:51:00Z","last_updated_date":"2019-06-24T15:51:00Z","reference_number":"EMA/215117/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2019-ema-decision-17-april-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-voclosporin-emea-002264-pip01-17_en.pdf"},
    {"id":"44828","name":"P/0100/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for migalastat (hydrochloride) (Galafold), (EMEA-001194-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T15:50:00Z","last_updated_date":"2019-06-24T15:50:00Z","reference_number":"EMA/169634/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0100-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-migalastat-hydrochloride-galafold-emea-001194-pip01-11-m04_en.pdf"},
    {"id":"44827","name":"P/0131/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Orbactiv), (EMEA-001270-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T15:43:00Z","last_updated_date":"2019-06-24T15:43:00Z","reference_number":"EMA/190111/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-oritavancin-diphosphate-orbactiv-emea-001270-pip01-12-m02_en.pdf"},
    {"id":"44826","name":"P/0137/2019: EMA decision of 17 April 2019 on the acceptance of a modification of an agreed paediatric investigation plan for migalastat (hydrochloride) (Galafold), (EMEA-001194-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:50:00Z","last_updated_date":"2019-06-24T14:50:00Z","reference_number":"EMA/190110/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2019-ema-decision-17-april-2019-acceptance-modification-agreed-paediatric-investigation-plan-migalastat-hydrochloride-galafold-emea-001194-pip01-11-m04_en.pdf"},
    {"id":"44825","name":"P/0127/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for 177Lu-PSMA-617 (EMEA-002419-PIP02-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:44:00Z","last_updated_date":"2019-06-24T14:44:00Z","reference_number":"EMA/190162/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2019-ema-decision-17-april-2019-granting-product-specific-waiver-177lu-psma-617-emea-002419-pip02-18_en.pdf"},
    {"id":"44824","name":"P/0088/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Recombinant Influenza Hemagglutinin-strain A (H1N1 subtype)... (EMEA-002418-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:26:00Z","last_updated_date":"2019-06-24T14:26:00Z","reference_number":"EMA/170154/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0088-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-influenza-hemagglutinin-strain-h1n1-subtype-emea-002418-pip01-18_en.pdf"},
    {"id":"44823","name":"P/0147/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for oteseconazole (EMEA-002392-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:18:00Z","last_updated_date":"2019-06-24T14:18:00Z","reference_number":"EMA/215121/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2019-ema-decision-17-april-2019-agreement-paediatric-investigation-plan-granting-waiver-oteseconazole-emea-002392-pip01-18_en.pdf"},
    {"id":"44821","name":"P/0109/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for ridinilazole (EMEA-002250-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:11:00Z","last_updated_date":"2019-06-24T14:11:00Z","reference_number":"EMA/170204/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-ridinilazole-emea-002250-pip02-17_en.pdf"},
    {"id":"44820","name":"P/0113/2019: EMA decision of 29 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for chemically modified recombinant human sulfamidase (EMEA-002380-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:09:00Z","last_updated_date":"2019-06-24T14:09:00Z","reference_number":"EMA/187096/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2019-ema-decision-29-march-2019-agreement-paediatric-investigation-plan-granting-deferral-chemically-modified-recombinant-human-sulfamidase-emea-002380-pip01-18_en.pdf"},
    {"id":"44819","name":"P/0110/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231) (EMEA-002378-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T14:03:00Z","last_updated_date":"2019-06-24T14:03:00Z","reference_number":"EMA/173738/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-n-hydroxy-5-methylfuran-2-sulfonamide-bms-986231-emea-002378-pip01-18_en.pdf"},
    {"id":"44812","name":"P/0149/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous T lymphocyte-enriched population of cells transduced...(EMEA-002369-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:22:00Z","last_updated_date":"2019-06-24T13:22:00Z","reference_number":"EMA/190160/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2019-ema-decision-17-april-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-t-lymphocyte-enriched-population-cells-transducedemea-002369-pip01-18_en.pdf"},
    {"id":"44816","name":"P/0093/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for 1-{[(2S,3S)- 2-carboxylato-3-methyl-4,4,7-trioxo-4-{6}-thia-1-azabi...(EMEA-002240-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:50:00Z","last_updated_date":"2019-06-24T13:50:00Z","reference_number":"EMA/107378/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-1-2s3s-2-carboxylato-3-methyl-447-trioxo-4-6-thia-1-azabiemea-002240-pip02-17_en.pdf"},
    {"id":"44794","name":"P/0091/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral for N-(1,3- dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H...(EMEA-002324-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T10:48:00Z","last_updated_date":"2019-06-24T10:48:00Z","reference_number":"EMA/107382/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-n-13-dimethyl-1h-pyrazole-4-sulfonyl-6-3-333-trifluoro-22-dimethylpropoxy-1hemea-002324-pip01-17_en.pdf"},
    {"id":"44817","name":"P/0148/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-IL-21 humanized immunoglobulin G1-kappa ... (BOS161721) (EMEA-002374-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:39:00Z","last_updated_date":"2019-06-24T13:39:00Z","reference_number":"EMA/215119/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2019-ema-decision-17-april-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-il-21-humanized-immunoglobulin-g1-kappa-bos161721-emea-002374-pip01-18_en.pdf"},
    {"id":"44818","name":"P/0119/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for orvepitant (EMEA-002510-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:50:00Z","last_updated_date":"2019-06-24T13:50:00Z","reference_number":"EMA/182611/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2019-ema-decision-17-april-2019-granting-product-specific-waiver-orvepitant-emea-002510-pip01-18_en.pdf"},
    {"id":"44815","name":"P/0120/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for rosuvastatin (calcium) / fenofibrate (EMEA-002509-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:44:00Z","last_updated_date":"2019-06-24T13:44:00Z","reference_number":"EMA/182619/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2019-ema-decision-17-april-2019-granting-product-specific-waiver-rosuvastatin-calcium-fenofibrate-emea-002509-pip01-18_en.pdf"},
    {"id":"44814","name":"P/0132/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for N2’-Deacetyl-N2’-[4-methyl-4-(oxobutyldithio)-1-oxopentyl]-maytansine-hu769_4D4 Antibody (EMEA-002504-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:34:00Z","last_updated_date":"2019-06-24T13:34:00Z","reference_number":"EMA/215102/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2019-ema-decision-17-april-2019-granting-product-specific-waiver-n2-deacetyl-n2-4-methyl-4-oxobutyldithio-1-oxopentyl-maytansine-hu769_4d4-antibody-emea-002504-pip01-18_en.pdf"},
    {"id":"44813","name":"P/0135/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for serlopitant (EMEA-002496-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:26:00Z","last_updated_date":"2019-06-24T13:26:00Z","reference_number":"EMA/215104/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2019-ema-decision-17-april-2019-granting-product-specific-waiver-serlopitant-emea-002496-pip01-18_en.pdf"},
    {"id":"44811","name":"P/0106/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mavacamten (EMEA-002231-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:21:00Z","last_updated_date":"2019-06-24T13:21:00Z","reference_number":"EMA/122333/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mavacamten-emea-002231-pip01-17_en.pdf"},
    {"id":"44810","name":"P/0140/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for rivoceranib (mesylate) (EMEA-002489-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:20:00Z","last_updated_date":"2019-06-24T13:20:00Z","reference_number":"EMA/190164/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2019-ema-decision-17-april-2019-granting-product-specific-waiver-rivoceranib-mesylate-emea-002489-pip01-18_en.pdf"},
    {"id":"44809","name":"P/0155/2019: EMA decision of 17 April 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for liposomal vinorelbine (tartrate) (EMEA-002365-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T12:03:00Z","last_updated_date":"2019-06-24T12:03:00Z","reference_number":"EMA/215265/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2019-ema-decision-17-april-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-liposomal-vinorelbine-tartrate-emea-002365-pip01-18_en.pdf"},
    {"id":"44808","name":"P/0142/2019: EMA decision of 17 April 2019 on the granting of a product specific waiver for tislelizumab (EMEA-002480-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T13:12:00Z","last_updated_date":"2019-06-24T13:12:00Z","reference_number":"EMA/215378/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2019-ema-decision-17-april-2019-granting-product-specific-waiver-tislelizumab-emea-002480-pip01-18_en.pdf"},
    {"id":"44806","name":"P/0105/2019: EMA decision of 22 March 2019 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (R)-azasetron (besylate) (SENS-401) (EMEA-002165-PIP02-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T12:51:00Z","last_updated_date":"2019-06-24T12:51:00Z","reference_number":"EMA/122334/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2019-ema-decision-22-march-2019-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-r-azasetron-besylate-sens-401-emea-002165-pip02-18_en.pdf"},
    {"id":"44804","name":"P/0075/2019: EMA decision of 22 March 2019 on the granting of a product specific waiver for n-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl) acetamide (KX2-391) (EMEA-002470-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-06-24T11:57:00Z","last_updated_date":"2019-06-24T11:57:00Z","reference_number":"EMA/145319/2019","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2019-ema-decision-22-march-2019-granting-product-specific-waiver-n-benzyl-2-5-4-2-morpholinoethoxyphenyl-pyridin-2-yl-acetamide-kx2-391-emea-002470-pip01-18_en.pdf"},
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    {"id":"43831","name":"P/0402/2018: EMA decision of 7 December 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bupivacaine (EMEA-000877-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T14:32:00Z","last_updated_date":"2019-02-20T14:32:00Z","reference_number":"EMA/843185/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0402-2018-ema-decision-7-december-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bupivacaine-emea-000877-pip03-17_en.pdf"},
    {"id":"43818","name":"P/0361/2018: EMA decision of 7 December 2018 on the granting of a product specific waiver for crizotinib (Xalkori), (EMEA-001493-PIP02-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:22:00Z","last_updated_date":"2019-02-20T12:22:00Z","reference_number":"EMA/762548/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0361-2018-ema-decision-7-december-2018-granting-product-specific-waiver-crizotinib-xalkori-emea-001493-pip02-18_en.pdf"},
    {"id":"43827","name":"P/0349/2018: EMA decision of 16 November 2018 on the agreement of a paediatric investigation plan for brincidofovir (EMEA-001904-PIP03-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T11:30:00Z","last_updated_date":"2019-02-20T11:30:00Z","reference_number":"EMA/784348/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0349-2018-ema-decision-16-november-2018-agreement-paediatric-investigation-plan-brincidofovir-emea-001904-pip03-18_en.pdf"},
    {"id":"43826","name":"P/0388/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lasmiditan, (EMEA-002166-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:53:00Z","last_updated_date":"2019-02-20T12:53:00Z","reference_number":"EMA/812167/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0388-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-lasmiditan-emea-002166-pip01-17-m01_en.pdf"},
    {"id":"43825","name":"P/0348/2018: EMA decision of 16 November 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for brincidofovir (EMEA-001904-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:50:00Z","last_updated_date":"2019-02-20T12:50:00Z","reference_number":"EMA/784346/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0348-2018-ema-decision-16-november-2018-agreement-paediatric-investigation-plan-granting-waiver-brincidofovir-emea-001904-pip02-17_en.pdf"},
    {"id":"43824","name":"P/0363/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for (RS)-baclofen / Naltrexone HCl / D-Sorbitol (PXT3003), (EMEA-002164-PIP01-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:48:00Z","last_updated_date":"2019-02-20T12:48:00Z","reference_number":"EMA/812165/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0363-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-rs-baclofen-naltrexone-hcl-d-sorbitol-pxt3003-emea-002164-pip01-17-m01_en.pdf"},
    {"id":"43823","name":"P/0388/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for risdiplam (RO7034067), (EMEA-002070-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:43:00Z","last_updated_date":"2019-02-20T12:43:00Z","reference_number":"EMA/812166/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0388-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-risdiplam-ro7034067-emea-002070-pip01-16-m02_en.pdf"},
    {"id":"43821","name":"P/0387/2018: EMA decision of 6 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1) / influenza virus surface antigens (haem","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:39:00Z","last_updated_date":"2019-02-20T12:39:00Z","reference_number":"EMA/775570/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0387-2018-ema-decision-6-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-h1n1-influenza-virus-surface_en.pdf"},
    {"id":"43820","name":"P/0394/2018: EMA decision of 7 December 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for upadacitinib (EMEA-001741-PIP04-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:32:00Z","last_updated_date":"2019-02-20T12:32:00Z","reference_number":"EMA/762538/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0394-2018-ema-decision-7-december-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-upadacitinib-emea-001741-pip04-17_en.pdf"},
    {"id":"43819","name":"P/0354/2018: EMA decision of 30 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for fenfluramine (hydrochloride) (EMEA-001990-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T11:23:00Z","last_updated_date":"2019-02-20T11:23:00Z","reference_number":"EMA/817525/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0354-2018-ema-decision-30-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-fenfluramine-hydrochloride-emea-001990-pip01-16-m02_en.pdf"},
    {"id":"43817","name":"P/0400/2018: EMA decision of  26 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deam","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:19:00Z","last_updated_date":"2019-02-20T12:19:00Z","reference_number":"EMA/762335/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0400-2018-ema-decision-26-november-2018-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-hematopoietic-stem-cells-transduced-ex-vivo-efs-lentiviral-vector-encoding-human_en.pdf"},
    {"id":"43814","name":"P/0388/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for liposomal combination of cytarabine and daunorubicin (Vyxeos), (EMEA-001858-PIP02-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-20T12:06:00Z","last_updated_date":"2019-02-20T12:06:00Z","reference_number":"EMA/710550/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0388-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-liposomal-combination-cytarabine-daunorubicin-vyxeos-emea-001858-pip02-16-m02_en.pdf"},
    {"id":"43787","name":"P/0389/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (LENVIMA, Kisplyx) (EMEA-001119-PIP02-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-19T10:06:00Z","last_updated_date":"2019-02-19T10:06:00Z","reference_number":"EMA/812163/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0389-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-lenvatinib-lenvima-kisplyx-emea-001119-pip02-12-m04_en.pdf"},
    {"id":"43791","name":"P/0376/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ixazomib (Ninlaro), (EMEA-001410-PIP02-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-19T10:38:00Z","last_updated_date":"2019-02-19T10:38:00Z","reference_number":"EMA/762192/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0376-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-ixazomib-ninlaro-emea-001410-pip02-17-m01_en.pdf"},
    {"id":"43790","name":"P/0355/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for potassium citrate monohydrated / potassium hydrogen carbonate (EMEA-001357-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-19T10:20:00Z","last_updated_date":"2019-02-19T10:20:00Z","reference_number":"EMA/796526/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0355-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-potassium-citrate-monohydrated-potassium-hydrogen-carbonate-emea-001357-pip01-12-m02_en.pdf"},
    {"id":"43789","name":"P/0362/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for phenylephrine hydrochloride / ketorolac trometamol (OMS302) (EMEA-001256-PIP02-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-19T10:15:00Z","last_updated_date":"2019-02-19T10:15:00Z","reference_number":"EMA/710628/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0362-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-phenylephrine-hydrochloride-ketorolac-trometamol-oms302-emea-001256-pip02-12-m02_en.pdf"},
    {"id":"43788","name":"P/0378/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-19T09:11:00Z","last_updated_date":"2019-02-19T09:11:00Z","reference_number":"EMA/812164/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0378-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m06_en.pdf"},
    {"id":"25230","name":"P/223/2011: EMA decision of 27 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for fingolimod (hydrochloride) (Gilenya) (EMEA-000087-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/763026/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-223-2011-ema-decision-27-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-fingolimod-hydrochloride-gilenya-emea-000087-pip01-07-m01_en.pdf"},
    {"id":"43777","name":"P/0373/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ex-vivo expanded human autologous epithelium containing stem cells (Holoclar), (EMEA-001082-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-18T15:29:00Z","last_updated_date":"2019-02-18T15:29:00Z","reference_number":"EMA/796524/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0373-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-ex-vivo-expanded-human-autologous-epithelium-containing-stem-cells-holoclar-emea-001082-pip02-11_en.pdf"},
    {"id":"43775","name":"P/0351/2018: EMA decision of 20 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ixekizumab (Taltz), (EMEA-001050-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-18T15:10:00Z","last_updated_date":"2019-02-18T15:10:00Z","reference_number":"EMA/762188/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0351-2018-ema-decision-20-november-2018-acceptance-modification-agreed-paediatric-investigation-plan-ixekizumab-taltz-emea-001050-pip01-10-m04_en.pdf"},
    {"id":"43773","name":"P/0380/2018: of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia), (EMEA-000916-PIP01-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-18T11:33:00Z","last_updated_date":"2019-02-18T11:33:00Z","reference_number":"EMA/762186/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0380-2018-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-lixisenatide-lyxumia-emea-000916-pip01-10-m06_en.pdf"},
    {"id":"43772","name":"P/0403/2018: of 19 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for bedaquiline (fumarate), (SIRTURO), (EMEA-000912-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-18T11:29:00Z","last_updated_date":"2019-02-18T11:29:00Z","reference_number":"EMA/868576/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0403-2018-19-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-bedaquiline-fumarate-sirturo-emea-000912-pip01-10-m04_en.pdf"},
    {"id":"43771","name":"P/0364/2018: of 6 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris), (EMEA-000876-PIP03-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-18T11:23:00Z","last_updated_date":"2019-02-18T11:23:00Z","reference_number":"EMA/775550/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0364-2018-6-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-eculizumab-soliris-emea-000876-pip03-14-m02_en.pdf"},
    {"id":"25506","name":"P/234/2011: EMA decision of 26 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for eltrombopag (EMEA-000170-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/706287/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-234-2011-ema-decision-26-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eltrombopag-emea-000170-pip02-10_en.pdf"},
    {"id":"43760","name":"P/0398/2018: EMA decision of 6 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP05-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-15T16:14:00Z","last_updated_date":"2019-02-15T16:14:00Z","reference_number":"EMA/775548/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0398-2018-ema-decision-6-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip05-13-m03_en.pdf"},
    {"id":"43759","name":"P/0353/2018: EMA decision of 22 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-15T16:08:00Z","last_updated_date":"2019-02-15T16:08:00Z","reference_number":"EMA/762023/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0353-2018-ema-decision-22-november-2018-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m13_en.pdf"},
    {"id":"43758","name":"P/0406/2018: EMA decision of 20 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium) (Zevtera and associated names), (EMEA-000205-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-15T15:03:00Z","last_updated_date":"2019-02-15T15:03:00Z","reference_number":"EMA/829510/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0406-2018-ema-decision-20-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-ceftobiprole-medocaril-sodium-zevtera-associated-names-emea-000205-pip02-11-m03_en.pdf"},
    {"id":"43748","name":"P/0399/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate mesilate (Pradaxa) (EMEA-000081-PIP01-07-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-15T11:27:00Z","last_updated_date":"2019-02-15T11:27:00Z","reference_number":"EMA/812162/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0399-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-mesilate-pradaxa-emea-000081-pip01-07-m11_en.pdf"},
    {"id":"43747","name":"P/0401/2018: EMA decision of 3 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for rabeprazole (sodium) (Pariet and associated names), (EMEA-000055-PIP01-07-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-15T11:23:00Z","last_updated_date":"2019-02-15T11:23:00Z","reference_number":"EMA/823217/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0401-2018-ema-decision-3-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-rabeprazole-sodium-pariet-associated-names-emea-000055-pip01-07-m06_en.pdf"},
    {"id":"43738","name":"P/0368/2018: EMA decision of 7 December 2018 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate) (Lixiana), (EMEA-000788-PIP02-11-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-14T18:01:00Z","last_updated_date":"2019-02-14T18:01:00Z","reference_number":"EMA/710591/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0368-2018-ema-decision-7-december-2018-acceptance-modification-agreed-paediatric-investigation-plan-edoxaban-tosylate-lixiana-emea-000788-pip02-11-m08_en.pdf"},
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    {"id":"18694","name":"P/143/2011: EMA decision of 9 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chemically modified extract of trees pollen from birch and...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/430651/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-143-2011-ema-decision-9-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chemically-modified-extract-trees-pollen-birch_en.pdf"},
    {"id":"29445","name":"P/0351/2016: EMA decision of 2 December 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pimavanserin (EMEA-001688-PIP03-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/765283/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0351-2016-ema-decision-2-december-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pimavanserin-emea-001688-pip03-16_en.pdf"},
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    {"id":"43625","name":"P/0308/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-04T12:11:00Z","last_updated_date":"2019-02-04T12:11:00Z","reference_number":"EMA/538888/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2018-ema-decision-12-september-2018-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m10_en.pdf"},
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    {"id":"43623","name":"P/0234/2018: of 15 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for vortioxetine (Brintellix), (EMEA-000455-PIP02-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-04T11:00:00Z","last_updated_date":"2019-02-04T11:00:00Z","reference_number":"EMA/472965/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2018-15-august-2018-acceptance-modification-agreed-paediatric-investigation-plan-vortioxetine-brintellix-emea-000455-pip02-10-m04_en.pdf"},
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    {"id":"43621","name":"P/0322/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (EDURANT), (EMEA-000317-PIP01-08-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-04T11:35:00Z","last_updated_date":"2019-02-04T11:35:00Z","reference_number":"EMA/538886/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0322-2018-ema-decision-12-september-2018-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m10_en.pdf"},
    {"id":"43597","name":"P/0246/2018: EMA decision of 15 Aug 2018 on the acceptance of a modification of an agreed PIP for (Z)-N-(3-bromo-4- fluorophenyl)-N-hydroxy-4-(2-(sulfamoylamino)ethylamino)-1,2,5-oxadiazole-3-carboximidamide (EMEA-002072-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-02-01T10:10:00Z","last_updated_date":"2019-02-01T10:10:00Z","reference_number":"EMA/469681/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2018-ema-decision-15-aug-2018-acceptance-modification-agreed-pip-z-n-3-bromo-4-fluorophenyl-n-hydroxy-4-2-sulfamoylaminoethylamino-125-oxadiazole-3-carboximidamide-emea-002072-pip01-16-m01_en.pdf"},
    {"id":"43585","name":"P/0323/2018: EMA decision of 12 September 2018 on the refusal of a modification of an agreed paediatric investigation plan for gadolinium (EMEA-001949-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T16:59:00Z","last_updated_date":"2019-01-31T16:59:00Z","reference_number":"EMA/584760/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0323-2018-ema-decision-12-september-2018-refusal-modification-agreed-paediatric-investigation-plan-gadolinium-emea-001949-pip01-16-m02_en.pdf"},
    {"id":"43584","name":"P/0261/2018: EMA decision of 15 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for Fc- and CDRmodified humanized monoclonal antibody against C5 (ALXN1210) (EMEA-001943-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T16:55:00Z","last_updated_date":"2019-01-31T16:55:00Z","reference_number":"EMA/471049/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0261-2018-ema-decision-15-august-2018-acceptance-modification-agreed-paediatric-investigation-plan-fc-cdrmodified-humanized-monoclonal-antibody-against-c5-alxn1210-emea-001943-pip01-16-m01_en.pdf"},
    {"id":"43583","name":"P/0285/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen concentrate (BT524) (EMEA-001931-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T16:51:00Z","last_updated_date":"2019-01-31T16:51:00Z","reference_number":"EMA/538566/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0285-2018-ema-decision-12-september-2018-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-concentrate-bt524-emea-001931-pip01-16-m01_en.pdf"},
    {"id":"43582","name":"P/0259/2018:  EMA decision of 15 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for balovaptan (EMEA-001918-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T16:46:00Z","last_updated_date":"2019-01-31T16:46:00Z","reference_number":"EMA/472036/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2018-ema-decision-15-august-2018-acceptance-modification-agreed-paediatric-investigation-plan-balovaptan-emea-001918-pip01-15-m01_en.pdf"},
    {"id":"43576","name":"P/0250/2018: EMA decision of 15 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (EMEA-001900-PIP02-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T16:18:00Z","last_updated_date":"2019-01-31T16:18:00Z","reference_number":"EMA/480857/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2018-ema-decision-15-august-2018-acceptance-modification-agreed-paediatric-investigation-plan-tralokinumab-emea-001900-pip02-17-m01_en.pdf"},
    {"id":"43573","name":"P/0242/2018: EMA decision of on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio) (EMEA-001849-PIP02-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T15:44:00Z","last_updated_date":"2019-01-31T15:44:00Z","reference_number":"EMA/480860/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2018-ema-decision-acceptance-modification-agreed-paediatric-investigation-plan-avelumab-bavencio-emea-001849-pip02-15-m02_en.pdf"},
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    {"id":"43569","name":"P/0310/2018: EMA decision of 1 October 2018 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza) (EMEA-001825-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T15:01:00Z","last_updated_date":"2019-01-31T15:01:00Z","reference_number":"EMA/652048/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2018-ema-decision-1-october-2018-acceptance-modification-agreed-paediatric-investigation-plan-darunavir-cobicistat-emtricitabine-tenofovir-alafenamide-symtuza-emea-001825-pip01-15-m02_en.pdf"},
    {"id":"43568","name":"P/0268/2018: EMA decision of 16 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for quizartinib (EMEA- 001821-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T14:22:00Z","last_updated_date":"2019-01-31T14:22:00Z","reference_number":"EMA/517234/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2018-ema-decision-16-august-2018-acceptance-modification-agreed-paediatric-investigation-plan-quizartinib-emea-001821-pip01-15-m02_en.pdf"},
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    {"id":"43565","name":"P/0315/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for macrogol 3350 / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride (NER1006) (EMEA-0017","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T12:00:00Z","last_updated_date":"2019-01-31T12:00:00Z","reference_number":"EMA/584751/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0315-2018-ema-decision-12-september-2018-acceptance-modification-agreed-paediatric-investigation-plan-macrogol-3350-sodium-ascorbate-sodium-sulfate-ascorbic-acid-sodium-chloride-potassium-chloride_en.pdf"},
    {"id":"43564","name":"P/0301/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) Reagila (EMEA-001652-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-31T11:52:00Z","last_updated_date":"2019-01-31T11:52:00Z","reference_number":"EMA/542030/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0301-2018-ema-decision-12-september-2018-acceptance-modification-agreed-paediatric-investigation-plan-cariprazine-hydrochloride-reagila-emea-001652-pip01-14-m02_en.pdf"},
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    {"id":"43556","name":"P/0299/2018: EMA decision of 12 September 2018 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (Trobalt), (EMEA-000116-PIP01-07-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-30T17:00:00Z","last_updated_date":"2019-01-30T17:00:00Z","reference_number":"EMA/584737/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2018-ema-decision-12-september-2018-acceptance-modification-agreed-paediatric-investigation-plan-retigabine-trobalt-emea-000116-pip01-07-m09_en.pdf"},
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    {"id":"43497","name":"P/0341/2018: EMA decision of 8 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2) / influenza virus surface antigens....","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-28T10:42:00Z","last_updated_date":"2019-01-28T10:42:00Z","reference_number":"EMA/768448/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0341-2018-ema-decision-8-november-2018-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-h3n2-influenza-virus-surface_en.pdf"},
    {"id":"43498","name":"P/0342/2018: EMA decision of 9 November 2018 on the acceptance of a modification of an agreed paediatric investigation plan for peanut allergen extract (EMEA-001481-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2019-01-28T11:45:00Z","last_updated_date":"2019-01-28T11:45:00Z","reference_number":"EMA/762194/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0342-2018-ema-decision-9-november-2018-acceptance-modification-agreed-paediatric-investigation-plan-peanut-allergen-extract-emea-001481-pip01-13-m03_en.pdf"},
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    {"id":"42817","name":"P/0224/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for 2-hydroxypropyl-ßcyclodextrin (HP-ß-CD) (EMEA-001866-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:45:00Z","last_updated_date":"2018-11-27T13:45:00Z","reference_number":"EMA/465549/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-2-hydroxypropyl-sscyclodextrin-hp-ss-cd-emea-001866-pip01-15-m02_en.pdf"},
    {"id":"43157","name":"P/0257/2018: EMA decision of 14 August 2018 on the acceptance of a modification of an agreed paediatric investigation plan for paclitaxel Abraxane), (EMEA-001308-PIP01-12-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-12-19T13:55:00Z","last_updated_date":"2018-12-19T13:55:00Z","reference_number":"EMA/521807/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0257-2018-ema-decision-14-august-2018-acceptance-modification-agreed-paediatric-investigation-plan-paclitaxel-abraxane-emea-001308-pip01-12-m02_en.pdf"},
    {"id":"20729","name":"P/0104/2018: EMA decision of 11 April 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obeticholic acid (Ocaliva), (EMEA-001304-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T02:00:00Z","last_updated_date":"2018-07-25T02:00:00Z","reference_number":"EMA/197888/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0104-2018-ema-decision-11-april-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-obeticholic-acid-ocaliva-emea-001304-pip03-17_en.pdf"},
    {"id":"20065","name":"P/127/2011: EMA decision of 8 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Afinitor) (EMEA-000019-PIP02-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-13T02:00:00Z","last_updated_date":"2011-07-13T02:00:00Z","reference_number":"EMA/396247/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-127-2011-ema-decision-8-june-2011-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-afinitor-emea-000019-pip02-07-m02_en.pdf"},
    {"id":"42984","name":"P/0215/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tasimelteon (Hetlioz), (EMEA-001531-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T12:10:00Z","last_updated_date":"2018-11-27T12:10:00Z","reference_number":"EMA/465547/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-tasimelteon-hetlioz-emea-001531-pip01-13-m04_en.pdf"},
    {"id":"34914","name":"P/134/2011: EMA decision of 8 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (phosphate monohydrate) (Januvia), (EMEA-000470-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-13T02:00:00Z","last_updated_date":"2011-07-13T02:00:00Z","reference_number":"EMA/356070/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-134-2011-ema-decision-8-june-2011-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-januvia-emea-000470-pip01-08-m04_en.pdf"},
    {"id":"42894","name":"P/0230/2018: EMA decision of 3 August 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for risankizumab (EMEA-001776-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-30T13:40:00Z","last_updated_date":"2018-11-30T13:40:00Z","reference_number":"EMA/480849/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2018-ema-decision-3-august-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-risankizumab-emea-001776-pip03-17_en.pdf-0"},
    {"id":"42893","name":"P/0231/2018: EMA decision of 3 August 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for risankizumab (EMEA-001776-PIP04-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-30T13:30:00Z","last_updated_date":"2018-11-30T13:30:00Z","reference_number":"EMA/469730/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2018-ema-decision-3-august-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-risankizumab-emea-001776-pip04-17_en.pdf-0"},
    {"id":"42881","name":"P/0152/2018: EMA decision of 18 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for emapalumab (EMEA-002031-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T17:42:00Z","last_updated_date":"2018-11-28T17:42:00Z","reference_number":"EMA/291263/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2018-ema-decision-18-may-2018-acceptance-modification-agreed-paediatric-investigation-plan-emapalumab-emea-002031-pip01-16-m01_en.pdf"},
    {"id":"42880","name":"P/0210/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for mexiletine (hydrochloride) (EMEA-002012-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T17:38:00Z","last_updated_date":"2018-11-28T17:38:00Z","reference_number":"EMA/465562/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-mexiletine-hydrochloride-emea-002012-pip01-16-m01_en.pdf"},
    {"id":"42879","name":"P/0177/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for fenfluramine (hydrochloride) (EMEA-001990-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T17:32:00Z","last_updated_date":"2018-11-28T17:32:00Z","reference_number":"EMA/366018/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-fenfluramine-hydrochloride-emea-001990-pip01-16-m01_en.pdf"},
    {"id":"42878","name":"P/0182/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for larotrectinib (EMEA-001971-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T17:27:00Z","last_updated_date":"2018-11-28T17:27:00Z","reference_number":"EMA/379661/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-larotrectinib-emea-001971-pip02-16-m01_en.pdf"},
    {"id":"42877","name":"P/0151/2018: EMA decision of 18 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lamivudine/dolutegravir (EMEA-001940-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T17:04:00Z","last_updated_date":"2018-11-28T17:04:00Z","reference_number":"EMA/291491/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2018-ema-decision-18-may-2018-acceptance-modification-agreed-paediatric-investigation-plan-lamivudine-dolutegravir-emea-001940-pip01-16-m01_en.pdf"},
    {"id":"42876","name":"P/0186/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for rimiducid (EMEA- 001870-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T16:45:00Z","last_updated_date":"2018-11-28T16:45:00Z","reference_number":"EMA/404189/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-rimiducid-emea-001870-pip01-15-m01_en.pdf"},
    {"id":"42875","name":"P/0149/2018: EMA decision of 17 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime / avibactam (Zavicefta), (EMEA-001313-PIP01-12-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T16:34:00Z","last_updated_date":"2018-11-28T16:34:00Z","reference_number":"EMA/288608/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2018-ema-decision-17-may-2018-acceptance-modification-agreed-paediatric-investigation-plan-ceftazidime-avibactam-zavicefta-emea-001313-pip01-12-m07_en.pdf"},
    {"id":"42873","name":"P/0172/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir (Sovaldi), (EMEA-001276-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T16:05:00Z","last_updated_date":"2018-11-28T16:05:00Z","reference_number":"EMA/366015/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-sofosbuvir-sovaldi-emea-001276-pip01-12-m02_en.pdf"},
    {"id":"42872","name":"P/0161/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for spheroids of human autologous matrix-associated chondrocytes (Spherox), (EMEA-001264-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T15:14:00Z","last_updated_date":"2018-11-28T15:14:00Z","reference_number":"EMA/324452/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-spheroids-human-autologous-matrix-associated-chondrocytes-spherox-emea-001264-pip01-12-m02_en.pdf"},
    {"id":"42870","name":"P/0176/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (Zinforo), (EMEA-000769-PIP01-09-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T14:20:00Z","last_updated_date":"2018-11-28T14:20:00Z","reference_number":"EMA/381903/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-zinforo-emea-000769-pip01-09-m08_en.pdf"},
    {"id":"42869","name":"P/0163/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP03-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T13:33:00Z","last_updated_date":"2018-11-28T13:33:00Z","reference_number":"EMA/352392/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip03-11-m05_en.pdf"},
    {"id":"42868","name":"P/0227/2018: EMA decision of 20 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pixantrone (dimaleate) (Pixuvri), (EMEA-000713-PIP02-10-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T13:24:00Z","last_updated_date":"2018-11-28T13:24:00Z","reference_number":"EMA/469707/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2018-ema-decision-20-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-pixantrone-dimaleate-pixuvri-emea-000713-pip02-10-m05_en.pdf"},
    {"id":"42867","name":"P/0203/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib, (Xeljanz), (EMEA-000576-PIP01-09-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T13:16:00Z","last_updated_date":"2018-11-28T13:16:00Z","reference_number":"EMA/465433/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-xeljanz-emea-000576-pip01-09-m09_en.pdf"},
    {"id":"42865","name":"P/0192/2018: EMA decision of 17 July 2018 on the refusal of a product specific waiver for trandolapril (EMEA-002274-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T12:46:00Z","last_updated_date":"2018-11-28T12:46:00Z","reference_number":"EMA/378944/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2018-ema-decision-17-july-2018-refusal-product-specific-waiver-trandolapril-emea-002274-pip01-17_en.pdf"},
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    {"id":"42863","name":"P/0162/2018: EMA decision of 15 June 2018 on the granting of a product specific waiver for verapamil / trandolapril (EMEA-002276-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T12:39:00Z","last_updated_date":"2018-11-28T12:39:00Z","reference_number":"EMA/366094/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2018-ema-decision-15-june-2018-granting-product-specific-waiver-verapamil-trandolapril-emea-002276-pip01-17_en.pdf"},
    {"id":"42862","name":"P/0134/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for (2R)-2-Amino-1-[3-({2-[p-(4-{3-[(3,5-diamino-6- chloro-2-pyrazinyl)carbonyl]guanidino}butyl)phenoxy]ethyl}{3-[(2R)-2-amino-6- guanidinohexanoylamino]propyl}amino)prop","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T12:31:00Z","last_updated_date":"2018-11-28T12:31:00Z","reference_number":"EMA/201423/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0134-2018-ema-decision-7-may-2018-granting-product-specific-waiver-2r-2-amino-1-3-2-p-4-3-35-diamino-6-chloro-2-pyrazinylcarbonylguanidinobutylphenoxyethyl3-2r-2-amino-6_en.pdf"},
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    {"id":"42857","name":"P/0212/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ enriched cell fraction that contains CD34+ cells transduced... (EMEA-001765-PIP02-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T10:42:00Z","last_updated_date":"2018-11-28T10:42:00Z","reference_number":"EMA/465551/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-enriched-cell-fraction-contains-cd34-cells-transduced-emea-001765-pip02-15-m02_en.pdf"},
    {"id":"42856","name":"P/0213/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for arimoclomol (citrate), (EMEA-001748-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T10:35:00Z","last_updated_date":"2018-11-28T10:35:00Z","reference_number":"EMA/465443/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-arimoclomol-citrate-emea-001748-pip01-15-m01_en.pdf"},
    {"id":"42852","name":"P/0170/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for peanut flour (EMEA-001734-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T09:32:00Z","last_updated_date":"2018-11-28T09:32:00Z","reference_number":"EMA/352391/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0170-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-peanut-flour-emea-001734-pip01-14-m02_en.pdf"},
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    {"id":"42850","name":"P/0146/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for naloxone (hydrochloride), (EMEA-001567-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-28T09:19:00Z","last_updated_date":"2018-11-28T09:19:00Z","reference_number":"EMA/259091/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0146-2018-ema-decision-7-may-2018-acceptance-modification-agreed-paediatric-investigation-plan-naloxone-hydrochloride-emea-001567-pip01-13-m03_en.pdf"},
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    {"id":"42846","name":"P/0156/2018: EMA decision of 15 June 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for isatuximab (EMEA-002205-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T18:23:00Z","last_updated_date":"2018-11-27T18:23:00Z","reference_number":"EMA/381998/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2018-ema-decision-15-june-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-isatuximab-emea-002205-pip01-17_en.pdf"},
    {"id":"42845","name":"P/0173/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for etelcalcetide (Parsabiv), (EMEA-001554-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T18:19:00Z","last_updated_date":"2018-11-27T18:19:00Z","reference_number":"EMA/366017/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-etelcalcetide-parsabiv-emea-001554-pip01-13-m02_en.pdf"},
    {"id":"42844","name":"P/0184/2018: EMA decision of 17 July 2018 on the refusal of a product specific waiver for liposomal ciclosporin A (L-CsA) (EMEA-002344-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T18:15:00Z","last_updated_date":"2018-11-27T18:15:00Z","reference_number":"EMA/403599/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2018-ema-decision-17-july-2018-refusal-product-specific-waiver-liposomal-ciclosporin-l-csa-emea-002344-pip01-18_en.pdf"},
    {"id":"42842","name":"P/0214/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for potassium citrate monohydrated / potassium hydrogen carbonate (ADV7103) (EMEA-001535-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T18:06:00Z","last_updated_date":"2018-11-27T18:06:00Z","reference_number":"EMA/465548/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-potassium-citrate-monohydrated-potassium-hydrogen-carbonate-adv7103-emea-001535-pip01-13-m01_en.pdf"},
    {"id":"42841","name":"P/0145/2018: EMA decision of 7 May 2018 on the granting of a product specific waiver for amlodipine / irbesartan (EMEA-002192-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T18:05:00Z","last_updated_date":"2018-11-27T18:05:00Z","reference_number":"EMA/258460/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2018-ema-decision-7-may-2018-granting-product-specific-waiver-amlodipine-irbesartan-emea-002192-pip02-17_en.pdf"},
    {"id":"42840","name":"P/0155/2018: EMA decision of 25 May 2018 on the granting of a product specific waiver for split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / split influenza virus, inactivated containing antigens equivalent to th","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T17:59:00Z","last_updated_date":"2018-11-27T17:59:00Z","reference_number":"EMA/324949/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2018-ema-decision-25-may-2018-granting-product-specific-waiver-split-influenza-virus-inactivated-containing-antigens-equivalent-h1n1-strain-split-influenza-virus-inactivated-containing-antigens_en.pdf"},
    {"id":"42839","name":"P/0189/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for brodalumab (EMEA- 001089-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T17:47:00Z","last_updated_date":"2018-11-27T17:47:00Z","reference_number":"EMA/403852/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-brodalumab-emea-001089-pip02-13-m01_en.pdf"},
    {"id":"42838","name":"P/0164/2018: EMA decision of of 15 June 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for setmelanotide (EMEA-002209-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T17:37:00Z","last_updated_date":"2018-11-27T17:37:00Z","reference_number":"EMA/328767/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2018-ema-decision-15-june-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-setmelanotide-emea-002209-pip01-17_en.pdf"},
    {"id":"42836","name":"P/0191/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for glycerol phenylbutyrate (Ravicti), (EMEA-000297-PIP02-12-M02","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T17:24:00Z","last_updated_date":"2018-11-27T17:24:00Z","reference_number":"EMA/403996/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-glycerol-phenylbutyrate-ravicti-emea-000297-pip02-12-m02_en.pdf"},
    {"id":"42835","name":"P/0205/2018: EMA decision of 19 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for Ticagrelor (Brilique), (EMEA-000480-PIP01-08-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T17:21:00Z","last_updated_date":"2018-11-27T17:21:00Z","reference_number":"EMA/421332/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2018-ema-decision-19-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-brilique-emea-000480-pip01-08-m11_en.pdf"},
    {"id":"42834","name":"P/0193/2018: EMA decision of 17 July 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bimekizumab (EMEA-002189-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T17:01:00Z","last_updated_date":"2018-11-27T17:01:00Z","reference_number":"EMA/375727/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2018-ema-decision-17-july-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bimekizumab-emea-002189-pip01-17_en.pdf"},
    {"id":"42833","name":"P/0207/2018: EMA decision of 17July 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol) (EMEA-002184-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T16:33:00Z","last_updated_date":"2018-11-27T16:33:00Z","reference_number":"EMA/466443/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2018-ema-decision-17july-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-r-2-amino-3-phenylpropylcarbamate-hydrochloride-solriamfetol-emea-002184-pip01-17_en.pdf"},
    {"id":"42832","name":"P/0208/2018: EMA decision of 17 July 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for itacitinib (EMEA-002178-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T16:14:00Z","last_updated_date":"2018-11-27T16:14:00Z","reference_number":"EMA/465554/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2018-ema-decision-17-july-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-itacitinib-emea-002178-pip01-17_en.pdf"},
    {"id":"42831","name":"P/0229/2018: EMA decision of 30 July 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant IgG degrading enzyme of Streptococcus pyogenes (EMEA-002183-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T16:11:00Z","last_updated_date":"2018-11-27T16:11:00Z","reference_number":"EMA/375899/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2018-ema-decision-30-july-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-igg-degrading-enzyme-streptococcus-pyogenes-emea-002183-pip01-17_en.pdf"},
    {"id":"42830","name":"P/0204/2018: EMA decision of 19 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta), (EMEA-000498-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T16:09:00Z","last_updated_date":"2018-11-27T16:09:00Z","reference_number":"EMA/421350/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2018-ema-decision-19-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-trajenta-emea-000498-pip01-08-m08_en.pdf"},
    {"id":"42829","name":"P/0167/2018: EMA decision of 15 June 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lasmiditan (EMEA-002166-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T15:40:00Z","last_updated_date":"2018-11-27T15:40:00Z","reference_number":"EMA/366138/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2018-ema-decision-15-june-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lasmiditan-emea-002166-pip01-17_en.pdf"},
    {"id":"42828","name":"P/0175/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lubiprostone (AMITIZA), (EMEA-000245-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T15:14:00Z","last_updated_date":"2018-11-27T15:14:00Z","reference_number":"EMA/324450/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-lubiprostone-amitiza-emea-000245-pip01-08-m05_en.pdf"},
    {"id":"42827","name":"P/0188/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pitolisant (Wakix),(EMEA-001176-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T15:10:00Z","last_updated_date":"2018-11-27T15:10:00Z","reference_number":"EMA/403688/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-pitolisant-wakixemea-001176-pip01-11-m03_en.pdf"},
    {"id":"42826","name":"P/0144/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (Remodulin and associated names), (EMEA-000207-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T15:08:00Z","last_updated_date":"2018-11-27T15:08:00Z","reference_number":"EMA/210453/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0144-2018-ema-decision-7-may-2018-acceptance-modification-agreed-paediatric-investigation-plan-treprostinil-remodulin-associated-names-emea-000207-pip01-08-m06_en.pdf"},
    {"id":"42825","name":"P/0157/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (Olumiant), (EMEA-001220-PIP01-11-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-11-27T14:57:00Z","last_updated_date":"2018-11-27T14:57:00Z","reference_number":"EMA/366003/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-olumiant-emea-001220-pip01-11-m03_en.pdf"},
    {"id":"42824","name":"P/0154/2018: EMA decision on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis), (EMEA-000183-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T14:49:00Z","last_updated_date":"2018-11-27T14:49:00Z","reference_number":"EMA/297918/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2018-ema-decision-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip01-08-m06_en.pdf"},
    {"id":"42822","name":"P/0180/2018: EMA decision of 15 June 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for daratumumab (Darzalex) (EMEA-002152-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T14:33:00Z","last_updated_date":"2018-11-27T14:33:00Z","reference_number":"EMA/278527/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2018-ema-decision-15-june-2018-agreement-paediatric-investigation-plan-granting-deferral-daratumumab-darzalex-emea-002152-pip01-17_en.pdf"},
    {"id":"42821","name":"P/0211/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata linea","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T14:31:00Z","last_updated_date":"2018-11-27T14:31:00Z","reference_number":"EMA/465552/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-following-strains-h1n1-h3n2-b-yamagata_en.pdf"},
    {"id":"42818","name":"P/0138/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for liquid ethanolic extract 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus limon (L.) Burm. f. (fresh fruit), Paullinia","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:52:00Z","last_updated_date":"2018-11-27T13:52:00Z","reference_number":"EMA/213297/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-liquid-ethanolic-extract-30-cent-w-w-allium-cepa-l-fresh-bulb-citrus-limon-l-burm-f-fresh-fruit_en.pdf"},
    {"id":"42816","name":"P/0209/2018: EMA decision of 17 July 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for palbociclib, (Ibrance), (EMEA-002146-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:37:00Z","last_updated_date":"2018-11-27T13:37:00Z","reference_number":"EMA/465362/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2018-ema-decision-17-july-2018-agreement-paediatric-investigation-plan-granting-waiver-palbociclib-ibrance-emea-002146-pip01-17_en.pdf"},
    {"id":"42815","name":"P/0166/2018: EMA decision of 15 June 2018 on the acceptance of a modification of an agreed paediatric investigation plan for glecaprevir/pibrentasvir (Maviret), (EMEA-001832-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:32:00Z","last_updated_date":"2018-11-27T13:32:00Z","reference_number":"EMA/324473/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2018-ema-decision-15-june-2018-acceptance-modification-agreed-paediatric-investigation-plan-glecaprevir-pibrentasvir-maviret-emea-001832-pip01-15-m01_en.pdf"},
    {"id":"42814","name":"P/0135/2018: EMA decision of 7 May 2018 on the granting of a product-specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:28:00Z","last_updated_date":"2018-11-27T13:28:00Z","reference_number":"EMA/258445/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2018-ema-decision-7-may-2018-granting-product-specific-waiver-ibuprofen-paracetamol-emea-002002-pip02-17_en.pdf"},
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    {"id":"42811","name":"P/0139/2018: EMA decision of 7 May 2018 on the agreement of a paediatric investigation plan and on the granting of a waiver for emtricitabine / tenofovir alafenamide (Descovy), (EMEA-001577-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:07:00Z","last_updated_date":"2018-11-27T13:07:00Z","reference_number":"EMA/209254/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2018-ema-decision-7-may-2018-agreement-paediatric-investigation-plan-granting-waiver-emtricitabine-tenofovir-alafenamide-descovy-emea-001577-pip03-17_en.pdf"},
    {"id":"42810","name":"P/0137/2018: EMA decision of 7 May 2018 on the acceptance of a modification of an agreed paediatric investigation plan for galcanezumab (EMEA-001860-PIP03-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T13:06:00Z","last_updated_date":"2018-11-27T13:06:00Z","reference_number":"EMA/213205/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2018-ema-decision-7-may-2018-acceptance-modification-agreed-paediatric-investigation-plan-galcanezumab-emea-001860-pip03-16-m01_en.pdf"},
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    {"id":"42808","name":"P/0194/2018: EMA decision of 17 July 2018 on the acceptance of a modification of an agreed paediatric investigation plan for expanded donorderived allogenic T cells transduced...(EMEA-001869-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T12:56:00Z","last_updated_date":"2018-11-27T12:56:00Z","reference_number":"EMA/404134/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2018-ema-decision-17-july-2018-acceptance-modification-agreed-paediatric-investigation-plan-expanded-donorderived-allogenic-t-cells-transducedemea-001869-pip01-15-m01_en.pdf"},
    {"id":"42807","name":"P/0140/2018: EMA decision of 7 May 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fosnetupitant / palonosetron (Akynzeo), (EMEA-001198-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-11-27T12:40:00Z","last_updated_date":"2018-11-27T12:40:00Z","reference_number":"EMA/202260/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2018-ema-decision-7-may-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fosnetupitant-palonosetron-akynzeo-emea-001198-pip03-17_en.pdf"},
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    {"id":"2688","name":"P/0061/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pazopanib (Votrient) (EMEA-000601-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/138317/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0061-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-pazopanib-votrient-emea-000601-pip01-09-m03_en.pdf"},
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    {"id":"2702","name":"P/0173/2013: EMA decision of 30 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 3-[[4-[(1S)-1-[4-(4-tert-butylphenyl)-3,5-dimethyl-pheno...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/375056/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2013-ema-decision-30-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-3-4-1s-1-4-4-tert-butylphenyl-35-dimethyl-pheno_en.pdf"},
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    {"id":"2726","name":"P/261/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for doripenem (monohydrate) (Doribax), (EMEA-000015-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/830158/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-261-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-doripenem-monohydrate-doribax-emea-000015-pip01-07-m03_en.pdf"},
    {"id":"2746","name":"P/0003/2018: EMA decision of 4 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for glutamine (levoglutamide) (EMEA-001996-PIP02-16)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T02:00:00Z","last_updated_date":"2018-04-17T02:00:00Z","reference_number":"EMA/501874/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0003-2018-ema-decision-4-january-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-glutamine-levoglutamide-emea-001996-pip02-16_en.pdf"},
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    {"id":"2758","name":"P/0163/2014: EMA decision of 16 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta), (EMEA-000498-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/329347/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2014-ema-decision-16-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-trajenta-emea-000498-pip01-08-m03_en.pdf"},
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    {"id":"2793","name":"P/0291/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for amlodipine (besylate) / candesartan (cilexetil) /\n\nhydrochlorothiazide (EMEA-002174-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/574573/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0291-2017-ema-decision-4-october-2017-granting-product-specific-waiver-amlodipine-besylate-candesartan-cilexetil-hydrochlorothiazide-emea-002174-pip01-17_en.pdf"},
    {"id":"2820","name":"P/0012/2012: EMA decision of 24 January 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for recombinant\n\ndimer of 6 kD early secretory antigenic target / recombinant 10 kD culture...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/968339/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2012-ema-decision-24-january-2012-agreement-paediatric-investigation-plan-granting-waiver-recombinant-dimer-6-kd-early-secretory-antigenic-target-recombinant-10-kd-culture_en.pdf"},
    {"id":"2836","name":"P/56/2009: European Medicines Agency decision of 24 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for tapentadol hydrochloride (EMEA-000486-PIP01-08) in accordance with ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/161794/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-56-2009-european-medicines-agency-decision-24-march-2009-agreement-paediatric-investigation-plan-granting-deferral-tapentadol-hydrochloride-emea-000486-pip01-08-accordance_en.pdf"},
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    {"id":"2891","name":"P/0155/2012: EMA decision of 24 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (EMEA-\n\n000335-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/472129/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2012-ema-decision-24-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-emea-000335-pip01-08-m06_en.pdf"},
    {"id":"2897","name":"P/77/2011: EMA decision of 5 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ciclosporin (EMEA-000988-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-13T02:00:00Z","last_updated_date":"2011-05-13T02:00:00Z","reference_number":"EMA/242217/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-77-2011-ema-decision-5-april-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ciclosporin-emea-000988-pip01-10_en.pdf"},
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    {"id":"3007","name":"P/0114/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for alogliptin (Vipidia), (EMEA-000496-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/284179/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0114-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-alogliptin-vipidia-emea-000496-pip01-08-m04_en.pdf"},
    {"id":"3010","name":"P/0034/2012: EMA decision of 3 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for inactivated type 1 poliovirus (Mahoney) / purified fimbriae types 2 and 3 (EMEA-000394-PIP01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/8478/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2012-ema-decision-3-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-inactivated-type-1-poliovirus-mahoney-purified-fimbriae-types-2-3-emea-000394-pip01_en.pdf"},
    {"id":"3012","name":"P/0120/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for andexanet alfa,\n\n(EMEA-001902-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/194606/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-andexanet-alfa-emea-001902-pip01-15-m02_en.pdf"},
    {"id":"3022","name":"P/303/2011: EMA decision of 21 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for macitentan (EMEA-001032-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/982770/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-303-2011-ema-decision-21-december-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-macitentan-emea-001032-pip01-10_en.pdf"},
    {"id":"3033","name":"P/0219/2014: EMA decision of 3 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/468294/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2014-ema-decision-3-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-enalapril-maleate-emea-001241-pip02-13-m01_en.pdf"},
    {"id":"3047","name":"P/0119/2012: EMA decision of 2 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for azithromycin (monohydrate), (EMEA-001145-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/405266/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2012-ema-decision-2-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-azithromycin-monohydrate-emea-001145-pip01-10_en.pdf"},
    {"id":"3062","name":"P/0040/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (EMEA-001119-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/797044/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-lenvatinib-emea-001119-pip02-12-m01_en.pdf"},
    {"id":"3071","name":"P/0037/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (as fumarate) (Vemlidy) (EMEA-001584-PIP01-13-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-27T18:50:00Z","last_updated_date":"2018-04-27T18:50:00Z","reference_number":"EMA/848792/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-alafenamide-fumarate-vemlidy-emea-001584-pip01-13-m03_en.pdf"},
    {"id":"3074","name":"P/0279/2012: EMA decision of 21 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lebrikizumab (EMEA-001053-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/717305/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0279-2012-ema-decision-21-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-lebrikizumab-emea-001053-pip01-10-m01_en.pdf"},
    {"id":"3079","name":"P/0181/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag\n\n(Revolade), (EMEA-000170-PIP03-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:05:00Z","last_updated_date":"2016-09-22T16:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-eltrombopag-revolade-emea-000170-pip03-13-m01_en.pdf"},
    {"id":"3103","name":"P/0078/2013: European medicines agency decision of 27 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/101626/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2013-european-medicines-agency-decision-27-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-emea-000332-pip01-08-m06_en.pdf"},
    {"id":"3115","name":"P/331/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for aqueous allergen extract of grass pollen (EMEA-00096...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/815095/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-331-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aqueous-allergen-extract-grass-pollen-emea-00096_en.pdf"},
    {"id":"3118","name":"P/0027/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for patiromer calcium\n\n(EMEA-001720-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/34939/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-patiromer-calcium-emea-001720-pip01-14-m01_en.pdf"},
    {"id":"3144","name":"P/0241/2013: EMA decision of 24 September 2013 on the granting of a product specific waiver for ramipril / amlodipine (besilate) (EMEA-001471-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/496894/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0241-2013-ema-decision-24-september-2013-granting-product-specific-waiver-ramipril-amlodipine-besilate-emea-001471-pip01-13_en.pdf"},
    {"id":"3210","name":"P/0292/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin\n\n(Forxiga), (EMEA-000694-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/693020/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0292-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip01-09-m03_en.pdf"},
    {"id":"3224","name":"P/0217/2017: EMA decision of 9 August 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tocilizumab (RoActemra), (EMEA-000309-PIP04-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/458626/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2017-ema-decision-9-august-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tocilizumab-roactemra-emea-000309-pip04-17_en.pdf"},
    {"id":"3232","name":"P/0260/2015: EMA decision of 30 October 2015 on the granting of a product specific waiver for mogamulizumab (EMEA-001816-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2015-12-22T13:00:00Z","reference_number":"EMA/624282/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2015-ema-decision-30-october-2015-granting-product-specific-waiver-mogamulizumab-emea-001816-pip01-15_en.pdf"},
    {"id":"3256","name":"P/0077/2016: EMA decision of 18 March 2016 on the granting of a product specific waiver for biotin (EMEA-001712-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/131679/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2016-ema-decision-18-march-2016-granting-product-specific-waiver-biotin-emea-001712-pip02-15_en.pdf"},
    {"id":"3269","name":"P/0316/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for acetylsalicylic acid / omeprazole (EMEA-001473-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/693817/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0316-2013-ema-decision-19-december-2013-granting-product-specific-waiver-acetylsalicylic-acid-omeprazole-emea-001473-pip01-13_en.pdf"},
    {"id":"3321","name":"P/0075/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for a derivative of 2-methyl-6-(5-methyl-3-phenyl-isoxazol-4...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/160752/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2015-ema-decision-1-april-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-derivative-2-methyl-6-5-methyl-3-phenyl-isoxazol-4_en.pdf"},
    {"id":"3325","name":"P/0053/2015: EMA decision of 6 March 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for olipudase alfa (EMEA-001600-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-24T01:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/111412/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2015-ema-decision-6-march-2015-agreement-paediatric-investigation-plan-granting-deferral-olipudase-alfa-emea-001600-pip01-13_en.pdf"},
    {"id":"3331","name":"P/0215/2014: EMA decision of 3 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec / insulin aspart (Ryzodeg) (EMEA-000479-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/454352/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2014-ema-decision-3-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-insulin-degludec-insulin-aspart-ryzodeg-emea-000479-pip01-08-m02_en.pdf"},
    {"id":"3339","name":"P/0078/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for gemtuzumab linked to ozogamicin (EMEA-001733-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/131580/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-gemtuzumab-linked-ozogamicin-emea-001733-pip02-15_en.pdf"},
    {"id":"3342","name":"P/57/2011: EMA decision of 4 March 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for human coagulation factor X (EMEA-000971-PIP01-10) in accordance with Regulation (EC) No 19...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/78582/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-57-2011-ema-decision-4-march-2011-agreement-paediatric-investigation-plan-granting-deferral-human-coagulation-factor-x-emea-000971-pip01-10-accordance-regulation-ec-no-19_en.pdf"},
    {"id":"3344","name":"P/217/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for birch pollen extract, (EMEA-0008...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/629233/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-217-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-birch-pollen-extract-emea-0008_en.pdf"},
    {"id":"3366","name":"P/0221/2015: EMA decision of 2 October 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for adenovirus associated viral vector serotype 2 containing the human RPE65 gene (EMEA-0016...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-19T01:00:00Z","last_updated_date":"2015-11-19T01:00:00Z","reference_number":"EMA/603716/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2015-ema-decision-2-october-2015-agreement-paediatric-investigation-plan-granting-waiver-adenovirus-associated-viral-vector-serotype-2-containing-human-rpe65-gene-emea-0016_en.pdf"},
    {"id":"3372","name":"P/0197/2016: EMA decision of of 18 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for corifollitropin alfa\n\n(Elonva), (EMEA-000306-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:05:00Z","last_updated_date":"2016-09-22T16:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2016-ema-decision-18-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-corifollitropin-alfa-elonva-emea-000306-pip01-08-m03_en.pdf"},
    {"id":"3394","name":"P/33/2011: EMA decision of the 28 January on the agreement of a PIP and on the granting of a deferral and a waiver for (2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]benzyl}-phenyl)-6-hydroxymethyltetra...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"EMA/35774/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-33-2011-ema-decision-28-january-agreement-pip-granting-deferral-waiver-2s3r4r5s6r-2-4-chloro-3-3-s-tetrahydrofuran-3-yloxybenzyl-phenyl-6-hydroxymethyltetra_en.pdf"},
    {"id":"3397","name":"P/0065/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for bedaquiline (fumarate) (Sirturo), (EMEA-000912-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/160743/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0065-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-bedaquiline-fumarate-sirturo-emea-000912-pip01-10-m02_en.pdf"},
    {"id":"3426","name":"P/0124/2013: EMA decision of 28 May 2013 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (Cayston), (EMEA-000827-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-21T13:30:00Z","last_updated_date":"2013-06-21T13:30:00Z","reference_number":"EMA/248608/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2013-ema-decision-28-may-2013-acceptance-modification-agreed-paediatric-investigation-plan-aztreonam-cayston-emea-000827-pip01-09-m02_en.pdf"},
    {"id":"3438","name":"P/0029/2015: EMA decision of 30 January 2015 on the granting of a product specific waiver for lutetium [177 Lu] (chloride) (EMEA-001674-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792665/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0029-2015-ema-decision-30-january-2015-granting-product-specific-waiver-lutetium-177-lu-chloride-emea-001674-pip01-14_en.pdf"},
    {"id":"3475","name":"P/0026/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for humanised anti-IL-6 receptor (IL-6R) monoclonal antibody (EMEA-001625-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/22662/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-humanised-anti-il-6-receptor-il-6r-monoclonal-antibody-emea-001625-pip01-14-m01_en.pdf"},
    {"id":"3485","name":"P/0069/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / abacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/155305/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0069-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-dolutegravir-abacavir-lamivudine-triumeq-emea-001219-pip01-11-m01_en.pdf"},
    {"id":"3486","name":"P/0168/2017: EMA decision of 3 July 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for omadacycline (EMEA-000560-PIP03-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/354131/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2017-ema-decision-3-july-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-omadacycline-emea-000560-pip03-15_en.pdf"},
    {"id":"3514","name":"P/0029/2012: EMA decision of 30 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for semuloparin sodium\n\n(EMEA-000562-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/931898/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0029-2012-ema-decision-30-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-semuloparin-sodium-emea-000562-pip01-09-m01_en.pdf"},
    {"id":"3521","name":"P/0112/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco) (EMEA-000335-PIP01-08-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/355412/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m10_en.pdf"},
    {"id":"3552","name":"P/0087/2018: EMA decision of 16 March 2018 on the granting of a product specific waiver for Entinostat Polymorph B (EMEA-002272-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/75586/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0087-2018-ema-decision-16-march-2018-granting-product-specific-waiver-entinostat-polymorph-b-emea-002272-pip01-17_en.pdf"},
    {"id":"3563","name":"P/0223/2015: EMA decision of 2 October 2015 on the granting of a product specific waiver for hydromorphone (hydrochloride) / naloxone (hydrochloride) (EMEA-001762-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-19T01:00:00Z","last_updated_date":"2015-11-19T01:00:00Z","reference_number":"EMA/603271/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2015-ema-decision-2-october-2015-granting-product-specific-waiver-hydromorphone-hydrochloride-naloxone-hydrochloride-emea-001762-pip01-15_en.pdf"},
    {"id":"3564","name":"P/0380/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (EMEA-001853-PIP01-15-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T16:03:00Z","last_updated_date":"2018-03-02T16:03:00Z","reference_number":"EMA/759103/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0380-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-001853-pip01-15-m01_en.pdf"},
    {"id":"3571","name":"P/202/2010: European Medicines Agency decision of 27 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for propranolol hydrochloride, (EMEA-000511-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/650134/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-202-2010-european-medicines-agency-decision-27-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-propranolol-hydrochloride-emea-000511-pip01-08-m02_en.pdf"},
    {"id":"3573","name":"P/0178/2012: EMA decision of 20 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for catridecacog (EMEA-\n\n000185-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/477706/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2012-ema-decision-20-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-catridecacog-emea-000185-pip01-08-m04_en.pdf"},
    {"id":"3593","name":"P/0059/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for saxagliptin (Onglyza) (EMEA-000200-PIP01-08-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/107875/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-saxagliptin-onglyza-emea-000200-pip01-08-m06_en.pdf"},
    {"id":"3609","name":"P/0271/2012: EMA decision of 20 November 2012 on the granting of a product-specific waiver for ezetimibe / rosuvastatin (EMEA-001344-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/646972/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0271-2012-ema-decision-20-november-2012-granting-product-specific-waiver-ezetimibe-rosuvastatin-emea-001344-pip01-12_en.pdf"},
    {"id":"3613","name":"P/0296/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium\n\ncyclosilicate (EMEA-001539-PIP01-13-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:17:00Z","last_updated_date":"2017-01-20T16:17:00Z","reference_number":"EMA/666520/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0296-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-sodium-zirconium-cyclosilicate-emea-001539-pip01-13-m01_en.pdf"},
    {"id":"3635","name":"P/0255/2014: EMA decision of 30 September 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for ibuprofen (sodium dihydrate), (EMEA-001599-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/519929/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0255-2014-ema-decision-30-september-2014-agreement-paediatric-investigation-plan-granting-waiver-ibuprofen-sodium-dihydrate-emea-001599-pip01-13_en.pdf"},
    {"id":"3637","name":"P/0177/2017: EMA decision of 3 July 2017 on the granting of a product specific waiver for olmesartan medoxomil/amlodipine (besilate)/hydrochlorothiazide (EMEA-002104-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/382336/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2017-ema-decision-3-july-2017-granting-product-specific-waiver-olmesartan-medoxomil-amlodipine-besilate-hydrochlorothiazide-emea-002104-pip01-16_en.pdf"},
    {"id":"3645","name":"P/140/2009: European Medicines Agency decision of 15 July 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for estradiol valerate / dienogest (Qlaira...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/387209/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-140-2009-european-medicines-agency-decision-15-july-2009-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-estradiol-valerate-dienogest-qlaira_en.pdf"},
    {"id":"3650","name":"P/307/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for modified allergen extract of grass and mugwort polle...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683319/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-307-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-mugwort-polle_en.pdf"},
    {"id":"3655","name":"P/0260/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dabrafenib (mesilate) (Tafinlar), (EMEA-001147-PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T17:00:00Z","last_updated_date":"2017-10-25T17:00:00Z","reference_number":"EMA/501662/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-dabrafenib-mesilate-tafinlar-emea-001147-pip01-11-m05_en.pdf"},
    {"id":"3684","name":"P/0302/2016: EMA decision of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for birch pollen extract (Betula verrucosa) (EMEA-001879-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T01:00:00Z","last_updated_date":"2017-01-10T01:00:00Z","reference_number":"EMA/669787/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2016-ema-decision-4-november-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-birch-pollen-extract-betula-verrucosa-emea-001879_en.pdf"},
    {"id":"3685","name":"P/0249/2012: EMA decision of 23 October 2012 on the granting of a product-specific waiver for etarfolatide (EMEA-001322-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/587270/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0249-2012-ema-decision-23-october-2012-granting-product-specific-waiver-etarfolatide-emea-001322-pip01-12_en.pdf"},
    {"id":"3694","name":"P/0197/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for exenatide (Byetta, Bydureon), (EMEA-000689-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/409211/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-exenatide-byetta-bydureon-emea-000689-pip01-09-m05_en.pdf"},
    {"id":"3708","name":"P/0154/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised anti-IL-6 receptor (IL-6R) monoclonal antibody...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/382979/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-humanised-anti-il-6-receptor-il-6r-monoclonal-antibody_en.pdf"},
    {"id":"3710","name":"P/0288/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron\n\n(Betmiga), (EMEA-000597-PIP03-15-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T10:48:00Z","last_updated_date":"2017-01-23T10:48:00Z","reference_number":"EMA/666528/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip03-15-m02_en.pdf"},
    {"id":"3725","name":"P/0187/2013: EMA decision of 8 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for levofloxacin (hemihydrate) (EMEA-001211-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-09T18:00:00Z","last_updated_date":"2013-09-09T18:00:00Z","reference_number":"EMA/473134/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2013-ema-decision-8-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-levofloxacin-hemihydrate-emea-001211-pip01-11-m01_en.pdf"},
    {"id":"3733","name":"P/0251/2012: EMA decision of 24 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for peginesatide (EMEA-000646-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/666263/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2012-ema-decision-24-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-peginesatide-emea-000646-pip01-09-m01_en.pdf"},
    {"id":"3762","name":"P/0251/2014: EMA decision of 30 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for sirukumab (EMEA-001043-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/519902/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2014-ema-decision-30-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-sirukumab-emea-001043-pip01-10-m01_en.pdf"},
    {"id":"3763","name":"P/0334/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for bempedoic acid / ezetimibe (EMEA-002200-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/666309/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0334-2017-ema-decision-31-october-2017-granting-product-specific-waiver-bempedoic-acid-ezetimibe-emea-002200-pip01-17_en.pdf"},
    {"id":"3767","name":"P/225/2010: European Medicines Agency decision of 29 October 2010 on the granting of a product specific waiver for 1H-Indole-6-carboxylic acid, 2,3-dihydro-3-[[[4-[methyl[(4-methyl-1-piperazinyl)acetyl] amino]phenyl]amin...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/644826/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-225-2010-european-medicines-agency-decision-29-october-2010-granting-product-specific-waiver-1h-indole-6-carboxylic-acid-23-dihydro-3-4-methyl4-methyl-1-piperazinylacetyl-aminophenylamin_en.pdf"},
    {"id":"3768","name":"P/0232/2012: EMA decision of 5 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Vezepra and associated names), (EMEA-000301-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/626080/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2012-ema-decision-5-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-vezepra-associated-names-emea-000301-pip01-08-m03_en.pdf"},
    {"id":"3781","name":"P/0015/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for terbinafine\n\n(hydrochloride) (EMEA-001259-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/38340/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-terbinafine-hydrochloride-emea-001259-pip02-13-m01_en.pdf"},
    {"id":"3807","name":"P/0144/2014: EMA decision of 13 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human monoclonal antibody to human interleukin-17A of the IgG1/kappa-class (AIN457)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/280412/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0144-2014-ema-decision-13-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-monoclonal-antibody-human-interleukin-17a-igg1-kappa-class-ain457_en.pdf"},
    {"id":"3829","name":"P/129/2008: European Medicines Agency decision of  23 December 2008 on the application for product specific waiver for pirfenidone EMEA-000357-PIP01-08 in accordance with Regulation (EC) No 1901/2006 of the European Parl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/664303/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-129-2008-european-medicines-agency-decision-23-december-2008-application-product-specific-waiver-pirfenidone-emea-000357-pip01-08-accordance-regulation-ec-no-1901-2006-european-parl_en.pdf"},
    {"id":"3846","name":"P/298/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pollen from dactylis glomerata, festuca pratensis, l...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683426/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-298-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-dactylis-glomerata-festuca-pratensis-l_en.pdf"},
    {"id":"3855","name":"P/65/2008: European medicines agency decision of 15 August 2008 on the application for agreement of a Paediatric Investigation Plan for balaglitazone\n\n(EMEA-000106-PIP01-07), in accordance with Regulation (EC) No 1901/20...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/429922/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-65-2008-european-medicines-agency-decision-15-august-2008-application-agreement-paediatric-investigation-plan-balaglitazone-emea-000106-pip01-07-accordance-regulation-ec-no-1901-20_en.pdf"},
    {"id":"3882","name":"P/0103/2014: EMA decision of 2 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for N-{2-(2,3-Difluorobenzylthio)-6-[(2R,3S)-3,4-dihydroxybut-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/232202/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2014-ema-decision-2-may-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-n-2-23-difluorobenzylthio-6-2r3s-34-dihydroxybut_en.pdf"},
    {"id":"3906","name":"P/153/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for rufinamide (Inovelon) (EMEA-000709-PIP01-09))","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/524353/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-153-2010-ema-decision-27-august-2010-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-rufinamide-inovelon-emea-000709-pip01-09_en.pdf"},
    {"id":"3907","name":"P/0132/2012: EMA decision of 4 July 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for tafluprost (Taflotan and associated names), (EMEA-001187-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/414428/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2012-ema-decision-4-july-2012-agreement-paediatric-investigation-plan-granting-waiver-tafluprost-taflotan-associated-names-emea-001187-pip01-11_en.pdf"},
    {"id":"3924","name":"P/0095/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/186577/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0095-2014-ema-decision-7-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"3956","name":"P/0236/2017: EMA decision of 9 August 2017 on the granting of a product specific waiver for recombinant humanized anti-alpha-synuclein IgG1\n\nmonoclonal antibody (EMEA-002137-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/434819/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2017-ema-decision-9-august-2017-granting-product-specific-waiver-recombinant-humanized-anti-alpha-synuclein-igg1-monoclonal-antibody-emea-002137-pip01-17_en.pdf"},
    {"id":"3976","name":"P/0170/2014: EMA decision of 9 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin, Januvia (EMEA-000470-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/392170/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0170-2014-ema-decision-9-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-januvia-emea-000470-pip01-08-m08_en.pdf"},
    {"id":"3977","name":"P/276/2011: EMA decision of 25 November 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human normal immunoglobulin (EMEA-001110-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T12:15:00Z","last_updated_date":"2011-12-21T12:15:00Z","reference_number":"EMA/908420/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-276-2011-ema-decision-25-november-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-normal-immunoglobulin-emea-001110-pip01-10_en.pdf"},
    {"id":"4001","name":"P/0199/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for deferasirox (Exjade), (EMEA-001103-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/439456/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-deferasirox-exjade-emea-001103-pip01-10-m01_en.pdf"},
    {"id":"4007","name":"P/0090/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203780/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-bosentan-tracleer-emea-000425-pip02-10-m04_en.pdf"},
    {"id":"4031","name":"P/0123/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tasimelteon (EMEA-001531-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/284185/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-tasimelteon-emea-001531-pip01-13-m01_en.pdf"},
    {"id":"4049","name":"P/41/2012: EMA decision of 28 February 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eliglustat (tartrate) (EMEA-000461-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/129490/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-41-2012-ema-decision-28-february-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eliglustat-tartrate-emea-000461-pip02-11_en.pdf"},
    {"id":"4073","name":"P/49/2011: EMA decision of 4 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M03), in accordance with Regulation (EC) No 1901/2006 of the E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/156014/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-49-2011-ema-decision-4-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-emea-000332-pip01-08-m03-accordance-regulation-ec-no-1901-2006-e_en.pdf"},
    {"id":"4081","name":"P/158/2010: European Medicines Agency decision of 6 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral for ceftaroline fosamil, (EMEA-000769-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/559070/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-158-2010-european-medicines-agency-decision-6-september-2010-agreement-paediatric-investigation-plan-granting-deferral-ceftaroline-fosamil-emea-000769-pip01-09_en.pdf"},
    {"id":"4111","name":"P/228/2011: EMA decision of 28 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for split Influenza virus,\n\ninactivated, containing antigen: A/California/7/2009 (H1N1)v like s...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/698108/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-228-2011-ema-decision-28-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigen-california-7-2009-h1n1v-s_en.pdf"},
    {"id":"4129","name":"P/34/2011: EMA decision of 28 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for house dust mites allergen extract from Dermatophagoide...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-24T01:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/58433/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-34-2011-ema-decision-28-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-house-dust-mites-allergen-extract-dermatophagoide_en.pdf"},
    {"id":"4142","name":"P/0025/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for finerenone (EMEA-001623-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792653/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-finerenone-emea-001623-pip01-14_en.pdf"},
    {"id":"4157","name":"P/34/2009: European Medicines Agency decision of 24 February 2009 on the granting of a product-specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of th...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/90603/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-34-2009-european-medicines-agency-decision-24-february-2009-granting-product-specific-waiver-pemetrexed-disodium-alimta-emea-000126-pip01-07-accordance-regulation-ec-no-1901-2006-th_en.pdf"},
    {"id":"4166","name":"P/0022/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dabrafenib (Tafinlar), (EMEA-001147-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/23029/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-dabrafenib-tafinlar-emea-001147-pip01-11-m03_en.pdf"},
    {"id":"4177","name":"P/0175/2014: EMA decision of 11 July 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obeticholic acid (6 alpha-ethylchenodeoxycholic acid), (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-31T12:00:00Z","last_updated_date":"2014-07-31T12:00:00Z","reference_number":"EMA/344720/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2014-ema-decision-11-july-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-obeticholic-acid-6-alpha-ethylchenodeoxycholic-acid_en.pdf"},
    {"id":"4191","name":"P/207/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for everolimus (Certican, Afinitor a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/656487/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-207-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-everolimus-certican-afinitor_en.pdf"},
    {"id":"4195","name":"P/105/2008: European Medicines Agency decision of 28 November 2008 on the application for agreement of a Paediatric Investigation Plan for liraglutide EMEA-000128-PIP01-07 in accordance with Regulation (EC) No 1901/2006 ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/625240/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-105-2008-european-medicines-agency-decision-28-november-2008-application-agreement-paediatric-investigation-plan-liraglutide-emea-000128-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"4200","name":"P/0206/2014: EMA decision of 8 August 2014 on the agreement of a paediatric investigation plan for captopril (EMEA-001544-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/392193/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2014-ema-decision-8-august-2014-agreement-paediatric-investigation-plan-captopril-emea-001544-pip01-13_en.pdf"},
    {"id":"4204","name":"P/100/2011: EMA decision of 11 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet hydrochloride (Mimpara), (EMEA-000078-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/289139/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-100-2011-ema-decision-11-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-cinacalcet-hydrochloride-mimpara-emea-000078-pip01-07-m02_en.pdf"},
    {"id":"4236","name":"P/0164/2014: EMA decision of 25 June 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for expanded autologous bone marrow-derived osteoblastic cel...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-31T12:00:00Z","last_updated_date":"2014-07-31T12:00:00Z","reference_number":"EMA/268706/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2014-ema-decision-25-june-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-expanded-autologous-bone-marrow-derived-osteoblastic-cel_en.pdf"},
    {"id":"4241","name":"P/251/2011: EMA decision of 25 October 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant\n\nfusion protein linking human coagulation factor IX with human albumin (EM...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/693940/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-251-2011-ema-decision-25-october-2011-agreement-paediatric-investigation-plan-granting-deferral-recombinant-fusion-protein-linking-human-coagulation-factor-ix-human-albumin-em_en.pdf"},
    {"id":"4277","name":"P/41/2011: EMA decision of 7 February 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mipomersen (sodium) (EMEA-000928-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2011-03-08T01:00:00Z","reference_number":"EMA/85088/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-41-2011-ema-decision-7-february-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mipomersen-sodium-emea-000928-pip01-10_en.pdf"},
    {"id":"4296","name":"P/0051/2014: European Medicines Agency decision of 7 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for citric acid (as citric acid anhydr...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/45733/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0051-2014-european-medicines-agency-decision-7-march-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-citric-acid-citric-acid-anhydr_en.pdf"},
    {"id":"4297","name":"P/195/2009: European Medicines Agency decision of 7 October 2009 on the granting of a product specific waiver for pegaptanib sodium, Macugen (EMEA-000611-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/604653/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-195-2009-european-medicines-agency-decision-7-october-2009-granting-product-specific-waiver-pegaptanib-sodium-macugen-emea-000611-pip01-09-accordance-regulation-ec-no-1901-2006-e_en.pdf"},
    {"id":"4305","name":"P/0275/2016: EMA decision of 7 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for peanut flour\n\n(EMEA-001734-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/632101/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0275-2016-ema-decision-7-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-peanut-flour-emea-001734-pip01-14-m01_en.pdf"},
    {"id":"4308","name":"P/0242/2014: EMA decision of 29 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for alogliptin (Vipidia), (EMEA-000496-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/527086/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2014-ema-decision-29-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-alogliptin-vipidia-emea-000496-pip01-08-m03_en.pdf"},
    {"id":"4313","name":"P/0098/2013: EMA decision of 29 April 2013 on the granting of a product-specific waiver for chlormethine (EMEA-001392-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201938/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0098-2013-ema-decision-29-april-2013-granting-product-specific-waiver-chlormethine-emea-001392-pip01-12_en.pdf"},
    {"id":"4316","name":"P/0190/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for regorafenib\n\n(Stivarga), (EMEA-001178-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:14:00Z","last_updated_date":"2016-09-22T16:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-regorafenib-stivarga-emea-001178-pip01-11-m02_en.pdf"},
    {"id":"4321","name":"P/0036/2013: EMA decision of 27 February 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for darunavir / cobicistat (EMEA-001280-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/24564/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2013-ema-decision-27-february-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-darunavir-cobicistat-emea-001280-pip01-12_en.pdf"},
    {"id":"4330","name":"P/0304/2016: EMA decision of 4 November 2016 on the granting of a product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T01:00:00Z","last_updated_date":"2017-01-10T01:00:00Z","reference_number":"EMA/639658/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2016-ema-decision-4-november-2016-granting-product-specific-waiver-perindopril-amlodipine-emea-001968-pip01-16_en.pdf"},
    {"id":"4357","name":"P/0086/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza, Saxenda) (EMEA-000128-PIP02-09-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/281883/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0086-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-saxenda-emea-000128-pip02-09-m01_en.pdf"},
    {"id":"4368","name":"P/168/2011: EMA decision of 8 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for aprepitant (Emend),\n\n(EMEA-000144-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/387100/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-168-2011-ema-decision-8-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-aprepitant-emend-emea-000144-pip01-07-m02_en.pdf"},
    {"id":"4388","name":"P/0317/2014: EMA decision of 11 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (Entyvio) (EMEA-000645-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/719224/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0317-2014-ema-decision-11-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-vedolizumab-entyvio-emea-000645-pip01-09-m02_en.pdf"},
    {"id":"4415","name":"P/0159/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for nonacog alfa, (EMEA-001139-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/443546/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-nonacog-alfa-emea-001139-pip01-11-m01_en.pdf"},
    {"id":"4417","name":"P/0342/2014: EMA decision of 12 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for drisapersen (EMEA-000746-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/737996/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0342-2014-ema-decision-12-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-drisapersen-emea-000746-pip01-09-m03_en.pdf"},
    {"id":"4437","name":"P/0239/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for cobicistat (EMEA-000969-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/636901/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-cobicistat-emea-000969-pip01-10-m01_en.pdf"},
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    {"id":"4487","name":"P/0280/2012: EMA decision of 21 November on the agreement of a paediatric investigation plan and on the granting of a deferral for tazobactam /\n\nceftolozane (EMEA-001142-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-07T01:00:00Z","last_updated_date":"2013-01-07T01:00:00Z","reference_number":"EMA/710289/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0280-2012-ema-decision-21-november-agreement-paediatric-investigation-plan-granting-deferral-tazobactam-ceftolozane-emea-001142-pip01-11_en.pdf"},
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    {"id":"4556","name":"P/0020/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for roxadustat (EMEA-001557-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792661/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-roxadustat-emea-001557-pip01-13_en.pdf"},
    {"id":"4560","name":"P/0262/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil\n\nfumarate) (Viread), (EMEA-000533-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T17:00:00Z","last_updated_date":"2017-10-25T17:00:00Z","reference_number":"EMA/552300/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0262-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m07_en.pdf"},
    {"id":"4562","name":"P/0197/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine (acetate) (Zebinix), (EMEA-000696-PIP02-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/483644/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2013-ema-decision-2-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-eslicarbazepine-acetate-zebinix-emea-000696-pip02-10-m04_en.pdf"},
    {"id":"4608","name":"P/0343/2016: EMA decision of 2 December 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant\n\nFusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; C...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/758347/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0343-2016-ema-decision-2-december-2016-agreement-paediatric-investigation-plan-granting-deferral-recombinant-fusion-protein-linking-coagulation-factor-viia-albumin-rviia-fp-c_en.pdf"},
    {"id":"4616","name":"P/0242/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for tilmanocept\n\n(Lymphoseek), (EMEA-001255-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/507355/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-tilmanocept-lymphoseek-emea-001255-pip01-11-m02_en.pdf"},
    {"id":"4643","name":"P/0022/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for grazoprevir (EMEA-001602-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/779740/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-grazoprevir-emea-001602-pip01-13_en.pdf"},
    {"id":"4649","name":"P/311/2011: EMA decision of 22 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for maraviroc (Celsentri), (EMEA-000020-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/931177/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-311-2011-ema-decision-22-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-maraviroc-celsentri-emea-000020-pip01-07-m02_en.pdf"},
    {"id":"4668","name":"P/0265/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for human recombinant\n\nIgG1 monoclonal antibody targeting fibroblast growth factor 23 (KRN23) (EM...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/576578/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-human-recombinant-igg1-monoclonal-antibody-targeting-fibroblast-growth-factor-23-krn23-em_en.pdf"},
    {"id":"4672","name":"P/0018/2013: EMA decision of 31 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil fumarate) (Viread), (EMEA-000533-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-08T12:00:00Z","last_updated_date":"2013-04-08T12:00:00Z","reference_number":"EMA/24109/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2013-ema-decision-31-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m04_en.pdf"},
    {"id":"4678","name":"P/55/2011: EMA decision of 4 March 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for (1R,2S)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta phenyl-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/155252/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-55-2011-ema-decision-4-march-2011-agreement-paediatric-investigation-plan-granting-deferral-1r2s-6-bromo-alpha-2-dimethylaminoethyl-2-methoxy-alpha-1-naphthalenyl-beta-phenyl_en.pdf"},
    {"id":"4684","name":"P/6/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Panobinostat as panobinostat lactate salt EMEA-000097-PIP01-07 in accordance with Regulation (EC) No 1901...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-01-15T01:00:00Z","last_updated_date":"2008-01-15T01:00:00Z","reference_number":"EMEA/43569/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-6-2008-european-medicines-agency-decision-1-february-2008-application-product-specific-waiver-panobinostat-panobinostat-lactate-salt-emea-000097-pip01-07-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"4692","name":"P/0162/2014: EMA decision of 13 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira), (EMEA-000366-PIP02-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/340720/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2014-ema-decision-13-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip02-09-m03_en.pdf"},
    {"id":"4705","name":"P/0363/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for\n\ndipalmitoylphosphatidylcholine / 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol so...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/788583/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0363-2016-ema-decision-21-december-2016-agreement-paediatric-investigation-plan-granting-waiver-dipalmitoylphosphatidylcholine-1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol-so_en.pdf"},
    {"id":"4710","name":"P/0054/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for encorafenib (EMEA-001588-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/133091/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0054-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-deferral-encorafenib-emea-001588-pip01-13_en.pdf"},
    {"id":"4725","name":"P/81/2011: EMA decision of 6 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine\n\nhydrochloride (Procoralan) (EMEA-000628-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/220941/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-81-2011-ema-decision-6-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-procoralan-emea-000628-pip01-09-m01_en.pdf"},
    {"id":"4735","name":"P/0037/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (as fumarate) (Vemlidy), (EMEA-001584-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/848792/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-alafenamide-fumarate-vemlidy-emea-001584-pip01-13-m03_en.pdf-0"},
    {"id":"4777","name":"P/271/2011: EMA decision of 28 October 2011 on the granting of a product specific waiver for (2S,3R,4R,5S,6R)-2-(4-chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol /...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/774939/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-271-2011-ema-decision-28-october-2011-granting-product-specific-waiver-2s3r4r5s6r-2-4-chloro-3-3-s-tetrahydrofuran-3-yloxy-benzyl-phenyl-6-hydroxymethyltetrahydro-pyran-345-triol_en.pdf"},
    {"id":"4786","name":"P/0181/2013: EMA decision of 31 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for colistimethate sodium (Colobreathe), (EMEA-000176-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/419466/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2013-ema-decision-31-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-colistimethate-sodium-colobreathe-emea-000176-pip01-07-m04_en.pdf"},
    {"id":"4792","name":"P/0063/2014: EMA decision of 7 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for fidaxomicin (Dificlir) (EMEA-000636-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/121846/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2014-ema-decision-7-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-fidaxomicin-dificlir-emea-000636-pip01-09-m02_en.pdf"},
    {"id":"4804","name":"P/0096/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/186585/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0096-2014-ema-decision-7-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"4811","name":"P/321/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of birch pollen (EMEA-00094...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/697309/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-321-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-birch-pollen-emea-00094_en.pdf"},
    {"id":"4863","name":"P/0093/2016: EMA decision of 23 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for octenidine (dihydrochloride) (EMEA-001514-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/199478/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2016-ema-decision-23-march-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-octenidine-dihydrochloride-emea-001514-pip01-13_en.pdf"},
    {"id":"4895","name":"P/0057/2014: European Medicines Agency decision of 6 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for herpes simplex 1 virus thymidine kinase and truncated low affinity...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/111582/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2014-european-medicines-agency-decision-6-march-2014-agreement-paediatric-investigation-plan-granting-deferral-herpes-simplex-1-virus-thymidine-kinase-truncated-low-affinity_en.pdf"},
    {"id":"4919","name":"P/0004/2015: EMA decision of 30 January 2015 on the granting of a product specific waiver for everolimus (Certican and associated names), (EMEA-000019-PIP11-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792666/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2015-ema-decision-30-january-2015-granting-product-specific-waiver-everolimus-certican-associated-names-emea-000019-pip11-14_en.pdf"},
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    {"id":"4939","name":"P/0012/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for melatonin (Circadin), (EMEA-000440-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/794178/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-melatonin-circadin-emea-000440-pip02-11-m02_en.pdf"},
    {"id":"4942","name":"P/17/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product-specific waiver for raltitrexed (Tomudex), EMEA-000400-PIP01-08, in accordance with Regulation (EC) No 1901/2006 of the Europe...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/29859/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-17-2009-european-medicines-agency-decision-27-january-2009-granting-product-specific-waiver-raltitrexed-tomudex-emea-000400-pip01-08-accordance-regulation-ec-no-1901-2006-europe_en.pdf"},
    {"id":"4944","name":"P/0013/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (EMEA-000576-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/43932/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-emea-000576-pip01-09-m05_en.pdf"},
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    {"id":"5083","name":"P/0284/2014: EMA decision of 28 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for turoctocog alfa pego (EMEA-001174-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-10T01:00:00Z","last_updated_date":"2014-12-10T01:00:00Z","reference_number":"EMA/590080/2014 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0284-2014-ema-decision-28-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-turoctocog-alfa-pego-emea-001174-pip02-12-m01_en.pdf"},
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    {"id":"5151","name":"P/0014/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for blinatumomab (EMEA-000574-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/23025/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-blinatumomab-emea-000574-pip02-12-m01_en.pdf"},
    {"id":"5152","name":"P/0351/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for teduglutide\n\n(Revestive), (EMEA-000482-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/709764/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0351-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-teduglutide-revestive-emea-000482-pip01-08-m04_en.pdf"},
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    {"id":"5173","name":"P/0024/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for trametinib (Mekinist), (EMEA-001177-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1364/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0024-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-trametinib-mekinist-emea-001177-pip01-11-m02_en.pdf"},
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    {"id":"5319","name":"P/0058/2014: European Medicines Agency decision of 6 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-human interleukin 23 p19 huma...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/112332/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2014-european-medicines-agency-decision-6-march-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-human-interleukin-23-p19-huma_en.pdf"},
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    {"id":"5589","name":"P/0070/2012: EMA decision of 4 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil citrate\n\n(Revatio), (EMEA-000671-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-27T13:00:00Z","last_updated_date":"2012-04-27T13:00:00Z","reference_number":"EMA/222891/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2012-ema-decision-4-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-citrate-revatio-emea-000671-pip01-09-m02_en.pdf"},
    {"id":"5606","name":"P/0256/2012: EMA decision of 26 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aripiprazole (Abilify), (EMEA-000235-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2013-03-21T13:00:00Z","reference_number":"EMA/646932/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2012-ema-decision-26-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-aripiprazole-abilify-emea-000235-pip02-10-m02_en.pdf"},
    {"id":"5621","name":"P/0003/2017: EMA decision of 12 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy),\n\n(EMEA-000117-PIP02-10-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/7963/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0003-2017-ema-decision-12-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip02-10-m07_en.pdf"},
    {"id":"5696","name":"P/54/2011: EMA decision of 4 March 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for 2'-O-methyluridylyl-( 3'→5' O,O-phosphorothioyl)-2'-O-methyl-cytidylyl-(3'→5' O,O-phos...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/155211/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-54-2011-ema-decision-4-march-2011-agreement-paediatric-investigation-plan-granting-deferral-2-o-methyluridylyl-3a5-oo-phosphorothioyl-2-o-methyl-cytidylyl-3a5-oo-phos_en.pdf"},
    {"id":"5702","name":"P/240/2011: EMA decision of 30 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for dextromethorphan (hydrobromide) / quinidine sulfate...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/706711/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-240-2011-ema-decision-30-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dextromethorphan-hydrobromide-quinidine-sulfate_en.pdf"},
    {"id":"5709","name":"P/0094/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira), (EMEA-000366-PIP05-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/195513/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip05-12-m01_en.pdf"},
    {"id":"5736","name":"P/0111/2014: EMA decision of 5 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fentanyl (hydrochloride) (EMEA-001509-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/169011/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2014-ema-decision-5-may-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fentanyl-hydrochloride-emea-001509-pip01-13_en.pdf"},
    {"id":"5740","name":"P/325/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass pollen (EMEA-00095...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769513/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-325-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-pollen-emea-00095_en.pdf"},
    {"id":"5741","name":"P/0281/2014: EMA decision of 28 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (Deltyba), (EMEA-001113-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-10T01:00:00Z","last_updated_date":"2014-12-10T01:00:00Z","reference_number":"EMA/587559/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0281-2014-ema-decision-28-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-delamanid-deltyba-emea-001113-pip01-10-m03_en.pdf"},
    {"id":"5780","name":"P/0320/2016: EMA decision of 21 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for methoxyflurane\n\n(Penthrox), (EMEA-000334-PIP01-08-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T11:23:00Z","last_updated_date":"2017-01-30T11:23:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0320-2016-ema-decision-21-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-methoxyflurane-penthrox-emea-000334-pip01-08-m05_en.pdf"},
    {"id":"5786","name":"P/0044/2018: EMA decision of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strain...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/83813/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2018-ema-decision-16-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-following-strain_en.pdf"},
    {"id":"5808","name":"P/211/2010: European Medicines Agency decision of 29 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (H5N1) / influenza virus surface antig...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/615237/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-211-2010-european-medicines-agency-decision-29-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-h5n1-influenza-virus-surface-antig_en.pdf"},
    {"id":"5839","name":"P/0228/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant varicella zoster virus (VZV) glycoprotein E (EMEA-001426-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/430894/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0228-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-varicella-zoster-virus-vzv-glycoprotein-e-emea-001426-pip01-13-m01_en.pdf"},
    {"id":"5841","name":"P/0101/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine (hydrochloride) (Corlentor) (EMEA-000627-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201371/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-corlentor-emea-000627-pip01-09-m04_en.pdf"},
    {"id":"5884","name":"P/0129/2017: EMA decision of 5 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/279562/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2017-ema-decision-5-may-2017-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigens-equivalent-b-strain-b-yamagat_en.pdf"},
    {"id":"5901","name":"P/155/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for bazedoxifene / conjugated estrogens, (EMEA-000998-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/477259/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-155-2010-european-medicines-agency-decision-3-september-2010-granting-product-specific-waiver-bazedoxifene-conjugated-estrogens-emea-000998-pip01-10_en.pdf"},
    {"id":"5914","name":"P/0288/2014: EMA decision of 12 December 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (R)-7-Chloro-benzo[b]thiophene-2-carboxylic acid (1-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/591053/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2014-ema-decision-12-december-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-r-7-chloro-benzobthiophene-2-carboxylic-acid-1_en.pdf"},
    {"id":"5919","name":"P/0287/2017: EMA decision of 4 October 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for autologous CD4+ and CD8+ T cells expressing a CD19-sp...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/626321/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0287-2017-ema-decision-4-october-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-cd4-cd8-t-cells-expressing-cd19-sp_en.pdf"},
    {"id":"5926","name":"P/0252/2016: EMA decision of 26 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide\n\n(Constella), (EMEA-000927-PIP01-10-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/557955/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2016-ema-decision-26-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-linaclotide-constella-emea-000927-pip01-10-m03_en.pdf"},
    {"id":"5939","name":"P/0165/2016: EMA decision of 15 June 2016 on the granting of a product specific waiver for imetelstat (EMEA-001910-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/380499/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2016-ema-decision-15-june-2016-granting-product-specific-waiver-imetelstat-emea-001910-pip01-15_en.pdf"},
    {"id":"5943","name":"P/0196/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for human-papillomavirus-type-6 L1 protein / human-papillomavirus-type-11 L1 protein / human-pa...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/456116/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2013-ema-decision-2-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-human-papillomavirus-type-6-l1-protein-human-papillomavirus-type-11-l1-protein-human-pa_en.pdf"},
    {"id":"5946","name":"P/271/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for allergens of birch pollen (betula alba / pendula / ve...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-10T01:00:00Z","last_updated_date":"2011-01-10T01:00:00Z","reference_number":"EMA/683356/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-271-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-allergens-birch-pollen-betula-alba-pendula-ve_en.pdf"},
    {"id":"5948","name":"P/0270/2017: EMA decision of 22 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for autologous T cells transduced with lentiviral vector containing a chimeric antigen recepto...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/615104/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0270-2017-ema-decision-22-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-autologous-t-cells-transduced-lentiviral-vector-containing-chimeric-antigen-recepto_en.pdf"},
    {"id":"5959","name":"P/0238/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ciclosporin (EMEA-\n\n000575-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/587077/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0238-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-ciclosporin-emea-000575-pip01-09-m02_en.pdf"},
    {"id":"5962","name":"P/0199/2015: EMA decision of 4 September 2015 on the granting of a product-specific waiver for torasemide / lisinopril (EMEA-001759-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/570750/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2015-ema-decision-4-september-2015-granting-product-specific-waiver-torasemide-lisinopril-emea-001759-pip01-15_en.pdf"},
    {"id":"5993","name":"P/0047/2014: European Medicines Agency decision of 11 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human normal immunoglobulin (EMEA...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/58370/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0047-2014-european-medicines-agency-decision-11-march-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-normal-immunoglobulin-emea_en.pdf"},
    {"id":"5994","name":"P/0258/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen (EMEA-001208-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/493103/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0258-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-emea-001208-pip01-11-m03_en.pdf"},
    {"id":"6006","name":"P/0218/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza),\n\n(EMEA-000128-PIP01-07-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-29T02:00:00Z","last_updated_date":"2017-09-29T02:00:00Z","reference_number":"EMA/459439/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m08_en.pdf"},
    {"id":"6031","name":"P/0216/2012: EMA decision of 28 September 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for pegylated B-domain-deleted sequence-modified recombinant human factor VIII, (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T18:45:00Z","last_updated_date":"2012-10-17T18:45:00Z","reference_number":"EMA/494657/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2012-ema-decision-28-september-2012-agreement-paediatric-investigation-plan-granting-deferral-pegylated-b-domain-deleted-sequence-modified-recombinant-human-factor-viii-emea-0_en.pdf"},
    {"id":"6034","name":"P/71/2010: European Medicines Agency decision of 5 May 2010 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab (RoActemra) (EMEA-000309-PIP01-08-M02) in accordance with Regulat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/267488/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-71-2010-european-medicines-agency-decision-5-may-2010-acceptance-modification-agreed-paediatric-investigation-plan-tocilizumab-roactemra-emea-000309-pip01-08-m02-accordance-regulat_en.pdf"},
    {"id":"6126","name":"P/0234/2014: EMA decision of 29 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (EMEA-000069-PIP02-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/520186/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2014-ema-decision-29-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip02-10-m04_en.pdf"},
    {"id":"6152","name":"P/0164/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / vilanterol (Relvar Ellipta and associated names), (EMEA-000431-PIP01-08-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/473687/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-vilanterol-relvar-ellipta-associated-names-emea-000431-pip01-08_en.pdf"},
    {"id":"6175","name":"P/0164/2013: EMA decision of 29 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for C1 inhibitor (Cinryze) (EMEA-000568-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/393013/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2013-ema-decision-29-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-c1-inhibitor-cinryze-emea-000568-pip01-09-m05_en.pdf"},
    {"id":"6192","name":"P/0288/2012: EMA decision of 26 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for serelaxin (EMEA-001168-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/737430/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2012-ema-decision-26-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-serelaxin-emea-001168-pip01-11-m01_en.pdf"},
    {"id":"6198","name":"P/0064/2012: EMA decision of 28 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for (3R,4R)-4-methyl-3-\n\n(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-1-piperidinepropanen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T17:42:00Z","last_updated_date":"2012-04-20T17:42:00Z","reference_number":"EMA/183907/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2012-ema-decision-28-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-3r4r-4-methyl-3-methyl-7h-pyrrolo23-dpyrimidin-4-ylamino-i2-oxo-1-piperidinepropanen_en.pdf"},
    {"id":"6211","name":"P/299/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for Pollen from Dactylis glomarata, Lolium perenne, Phle...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/778321/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-299-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-dactylis-glomarata-lolium-perenne-phle_en.pdf"},
    {"id":"6228","name":"P/0185/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris)\n\n(EMEA-000876-PIP05-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:12:00Z","last_updated_date":"2016-09-22T16:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-eculizumab-soliris-emea-000876-pip05-15-m01_en.pdf"},
    {"id":"6232","name":"P/0287/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for cysteamine hydrochloride (EMEA-000322-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/708150/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0287-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-cysteamine-hydrochloride-emea-000322-pip01-08-m03_en.pdf"},
    {"id":"6243","name":"P/0285/2014: EMA decision of 28 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for 4-((2R,3S,4R,5S)-3-(3-chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-ne...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-04T01:00:00Z","last_updated_date":"2014-12-04T01:00:00Z","reference_number":"EMA/605314/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0285-2014-ema-decision-28-october-2014-agreement-paediatric-investigation-plan-granting-deferral-4-2r3s4r5s-3-3-chloro-2-fluorophenyl-4-4-chloro-2-fluorophenyl-4-cyano-5-ne_en.pdf"},
    {"id":"6244","name":"P/0054/2013: European medicines agency decision of 25 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (EMEA-000069-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/101962/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0054-2013-european-medicines-agency-decision-25-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip02-10-m01_en.pdf"},
    {"id":"6255","name":"P/0143/2014: EMA decision of 13 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ocrelizumab (EMEA-000310-PIP03-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/268693/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2014-ema-decision-13-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-ocrelizumab-emea-000310-pip03-10-m01_en.pdf"},
    {"id":"6263","name":"P/0117/2016: EMA decision of 22 April 2016 on the granting of a product specific waiver for levodopa (EMEA-001874-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/269231/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0117-2016-ema-decision-22-april-2016-granting-product-specific-waiver-levodopa-emea-001874-pip01-15_en.pdf"},
    {"id":"6267","name":"P/0075/2014: EMA decision of 2 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000775-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/52893/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2014-ema-decision-2-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000775-pip01-09-m01_en.pdf"},
    {"id":"6279","name":"P/0308/2014: EMA decision of 24 November 2014 on the granting of a product specific waiver for macrogol 3350 (EMEA-001668-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/642067/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2014-ema-decision-24-november-2014-granting-product-specific-waiver-macrogol-3350-emea-001668-pip01-14_en.pdf"},
    {"id":"6318","name":"P/0113/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000454-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/355377/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000454-pip01-08-m06_en.pdf"},
    {"id":"6323","name":"P/0181/2015: EMA decision on the granting of a product-specific waiver: DNA, d(P-thio)([2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rC-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl)]m5rU-[2'-0-(2-methoxyethyl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-24T02:00:00Z","last_updated_date":"2015-09-24T02:00:00Z","reference_number":"EMA/473568/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2015-ema-decision-granting-product-specific-waiver-dna-dp-thio2-0-2-methoxyethylm5ru-2-0-2-methoxyethylm5rc-2-0-2-methoxyethylm5ru-2-0-2-methoxyethylm5ru-2-0-2-methoxyethyl_en.pdf"},
    {"id":"6330","name":"P/0148/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride)(Palexia and associated names, Yantil and associated names, Tapentadol...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/305255/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloridepalexia-associated-names-yantil-associated-names-tapentadol_en.pdf"},
    {"id":"6393","name":"P/0310/2012: EMA decision of 21 December 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human dermal fibroblasts cultured on bioresorbable p...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T14:00:00Z","last_updated_date":"2013-02-08T14:00:00Z","reference_number":"EMA/810422/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2012-ema-decision-21-december-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-dermal-fibroblasts-cultured-bioresorbable-p_en.pdf"},
    {"id":"6408","name":"P/0270/2013: EMA decision of 30 October 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for eptacog alfa (activated) (EMEA-001382-PIP01-12)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/585994/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0270-2013-ema-decision-30-october-2013-agreement-paediatric-investigation-plan-granting-waiver-eptacog-alfa-activated-emea-001382-pip01-12_en.pdf"},
    {"id":"6411","name":"P/0225/2012: EMA decision of 3 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (Trobalt), (EMEA-000116-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/610846/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2012-ema-decision-3-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-retigabine-trobalt-emea-000116-pip01-07-m05_en.pdf"},
    {"id":"6413","name":"P/0235/2014: EMA decision of 8 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for brodalumab (EMEA-001089-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-10-09T02:00:00Z","last_updated_date":"2014-10-09T02:00:00Z","reference_number":"EMA/519145/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2014-ema-decision-8-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-brodalumab-emea-001089-pip02-13_en.pdf"},
    {"id":"6422","name":"P/0285/2017: EMA decision of 4 October 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for entospletinib (EMEA-002058-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/574574/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0285-2017-ema-decision-4-october-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-entospletinib-emea-002058-pip01-16_en.pdf"},
    {"id":"6423","name":"P/0043/2013: European medicines agency decision of 1 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for boceprevir (Victrelis), (EMEA-000583-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/68060/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2013-european-medicines-agency-decision-1-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-boceprevir-victrelis-emea-000583-pip01-09-m05_en.pdf"},
    {"id":"6435","name":"P/0116/2016: EMA decision of 22 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rufinamide (Inovelon), (EMEA-000709-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/249393/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0116-2016-ema-decision-22-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-rufinamide-inovelon-emea-000709-pip01-09-m05_en.pdf"},
    {"id":"6453","name":"P/0269/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for lurasidone (hydrochloride) (EMEA-001230-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/588810/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-lurasidone-hydrochloride-emea-001230-pip01-11-m01_en.pdf"},
    {"id":"6508","name":"P/0350/2017: EMA decision of 1 December 2017 on the refusal of a modification of an agreed paediatric investigation plan for mirabegron\n\n(Betmiga), (EMEA-000597-PIP02-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/724286/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0350-2017-ema-decision-1-december-2017-refusal-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip02-10-m06_en.pdf"},
    {"id":"6512","name":"P/0036/2012: EMA decision of 13 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pixantrone (EMEA-\n\n000713-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/94189/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2012-ema-decision-13-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-pixantrone-emea-000713-pip02-10-m01_en.pdf"},
    {"id":"6521","name":"P/213/2009: European Medicines Agency decision of 30 October 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for sitagliptin (phosphate monohydrate) (Tesavel) (EMEA-000472-PIP01-08-M01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/691459/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-213-2009-european-medicines-agency-decision-30-october-2009-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-tesavel-emea-000472-pip01-08-m01_en.pdf"},
    {"id":"6535","name":"P/31/2011: EMA decision of the 28 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for amikacin (sulfate) (EMEA-000525-PIP01-08) in accor...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"EMA/34144/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-31-2011-ema-decision-28-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-amikacin-sulfate-emea-000525-pip01-08-accor_en.pdf"},
    {"id":"6553","name":"P/203/2011: EMA decision of 31 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo),\n\n(EMEA-000065-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/505512/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-203-2011-ema-decision-31-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-telbivudine-sebivo-emea-000065-pip01-07-m02_en.pdf"},
    {"id":"6597","name":"P/224/2011: EMA decision of 27 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for exenatide (Byetta)\n\n(EMEA-000689-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/686495/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-224-2011-ema-decision-27-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-exenatide-byetta-emea-000689-pip01-09-m03_en.pdf"},
    {"id":"6619","name":"P/0295/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen /\n\nhuman thrombin (Raplixa), (EMEA-001340-PIP01-12-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:17:00Z","last_updated_date":"2017-01-20T16:17:00Z","reference_number":"EMA/666531/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-human-thrombin-raplixa-emea-001340-pip01-12-m02_en.pdf"},
    {"id":"6632","name":"P/106/2011: EMA decision of 4 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ataluren (EMEA-000115-PIP02-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/299522/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-106-2011-ema-decision-4-may-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ataluren-emea-000115-pip02-09_en.pdf"},
    {"id":"6678","name":"P/0132/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dimethyl fumarate (Tecfidera), (EMEA-000832-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/287340/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-dimethyl-fumarate-tecfidera-emea-000832-pip01-10-m03_en.pdf"},
    {"id":"6709","name":"P/0095/2017: EMA decision of 11 April 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for rVSVΔG-ZEBOV-GP (EMEA-001786-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/196323/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0095-2017-ema-decision-11-april-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rvsvig-zebov-gp-emea-001786-pip01-15_en.pdf"},
    {"id":"6710","name":"P/0027/2012: EMA decision of 27 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for laquinimod (sodium)\n\n(EMEA-000972-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/57911/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2012-ema-decision-27-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-laquinimod-sodium-emea-000972-pip01-10-m01_en.pdf"},
    {"id":"6727","name":"P/0241/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (EMEA-001113-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/636914/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0241-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-delamanid-emea-001113-pip01-10-m01_en.pdf"},
    {"id":"6732","name":"P/0023/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for albiglutide (Eperzan), (EMEA-001175-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1363/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-albiglutide-eperzan-emea-001175-pip01-11-m03_en.pdf"},
    {"id":"6745","name":"P/0047/2016: EMA decision of 3 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rolapitant (EMEA-001768-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/131427/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0047-2016-ema-decision-3-march-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rolapitant-emea-001768-pip02-15_en.pdf"},
    {"id":"6753","name":"P/0212/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for zanamivir (Relenza),\n\n(EMEA-001318-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/430892/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-zanamivir-relenza-emea-001318-pip01-12-m02_en.pdf"},
    {"id":"6758","name":"P/0259/2015: EMA decision of 30 October 2015\n\non the granting of a product specific waiver for L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-Î...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2015-12-22T13:00:00Z","reference_number":"EMA/627030/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2015-ema-decision-30-october-2015-granting-product-specific-waiver-l-cysteine-l-leucyl-l-i-glutamyl-l-i-glutamyl-l-lysyl-l-lysylglycyl-l-asparaginyl-l-tyrosyl-l-valyl-l-valyl-l-threonyl-l-i_en.pdf"},
    {"id":"6760","name":"P/0116/2013: EMA decision of 26 April 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for paclitaxel (Abraxane), (EMEA-001308-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/245670/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0116-2013-ema-decision-26-april-2013-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-paclitaxel-abraxane-emea-001308-pip01-12_en.pdf"},
    {"id":"6762","name":"P/0345/2016: EMA decision of 2 December 2016 on the granting of a product specific waiver for teprotumumab (EMEA-001973-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/741998/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0345-2016-ema-decision-2-december-2016-granting-product-specific-waiver-teprotumumab-emea-001973-pip01-16_en.pdf"},
    {"id":"6772","name":"P/0262/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Bi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/597267/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0262-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-pandemic-influenza-vaccine-h5n1-split-virion-inactivated-adjuvanted-glaxosmithkline-bi_en.pdf"},
    {"id":"6783","name":"P/0159/2015: EMA decision of 13 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for meropenem (EMEA-000898-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/364926/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2015-ema-decision-13-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-meropenem-emea-000898-pip01-10-m01_en.pdf"},
    {"id":"6784","name":"P/179/2011: EMA decision of 1 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for anagrelide (Xagrid),\n\n(EMEA-000720-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/500865/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-179-2011-ema-decision-1-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-anagrelide-xagrid-emea-000720-pip01-09-m01_en.pdf"},
    {"id":"6785","name":"P/0302/2013: EMA decision of of 29 November 2013 on the granting of a product-specific waiver for lanreotide (acetate) (Somatuline LA and associated names) (EMEA-001503-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-17T12:00:00Z","last_updated_date":"2014-01-17T12:00:00Z","reference_number":"EMEA-001503-PIP01-13","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2013-ema-decision-29-november-2013-granting-product-specific-waiver-lanreotide-acetate-somatuline-la-associated-names-emea-001503-pip01-13_en.pdf"},
    {"id":"6839","name":"P/0027/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan for recombinant human heparan N-sulfatase (rhHNS) (EMEA-001634-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/794400/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-recombinant-human-heparan-n-sulfatase-rhhns-emea-001634-pip01-14_en.pdf"},
    {"id":"6855","name":"P/0198/2015: EMA decision of 4 September 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ozanimod (EMEA-001710-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/568910/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2015-ema-decision-4-september-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ozanimod-emea-001710-pip02-14_en.pdf"},
    {"id":"6857","name":"P/0323/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for amlodipine / ramipril (EMEA-001685-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/755900/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0323-2014-ema-decision-19-december-2014-granting-product-specific-waiver-amlodipine-ramipril-emea-001685-pip01-14_en.pdf"},
    {"id":"6875","name":"P/0354/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for telavancin\n\n(hydrochloride) (Vibativ), (EMEA-000239-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/763133/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0354-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-telavancin-hydrochloride-vibativ-emea-000239-pip01-08-m03_en.pdf"},
    {"id":"6877","name":"P/0118/2012: EMA decision of 2 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tadalafil (Adcirca, Cialis) (EMEA-000452-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/405309/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0118-2012-ema-decision-2-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-tadalafil-adcirca-cialis-emea-000452-pip02-10-m01_en.pdf"},
    {"id":"6889","name":"P/0044/2013: EMA decision of 1 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for volasertib (EMEA-000674-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/118204/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2013-ema-decision-1-march-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-volasertib-emea-000674-pip02-11_en.pdf"},
    {"id":"6911","name":"P/0010/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon alfa-2a (Pegasys), (EMEA-000298-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/23022/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-peginterferon-alfa-2a-pegasys-emea-000298-pip01-08-m05_en.pdf"},
    {"id":"6922","name":"P/0269/2016: EMA decision of 7 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (Deltyba),\n\n(EMEA-001113-PIP01-10-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/632684/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2016-ema-decision-7-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-delamanid-deltyba-emea-001113-pip01-10-m05_en.pdf"},
    {"id":"6946","name":"P/13/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for telmisartan and amlodipine besylate (EMEA-000377-PIP01-08) in accordance with Regulation (EC) No 1901/2006...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/26624/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-13-2009-european-medicines-agency-decision-27-january-2009-granting-product-specific-waiver-telmisartan-amlodipine-besylate-emea-000377-pip01-08-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"6953","name":"P/0059/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Afinitor, Certican and associated names), (EMEA-000019-PIP06...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/85730/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-afinitor-certican-associated-names-emea-000019-pip06_en.pdf"},
    {"id":"6965","name":"P/0029/2013: EMA decision of 26 February 2013 on the granting of a product specific waiver for strontium succinate / Vitamin D3, (EMEA-001131-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/65773/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0029-2013-ema-decision-26-february-2013-granting-product-specific-waiver-strontium-succinate-vitamin-d3-emea-001131-pip02-12_en.pdf"},
    {"id":"6980","name":"P/300/2010: EMA decision of 22 December 2010 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/778360/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-300-2010-ema-decision-22-december-2010-agreement-pip-granting-deferral-granting-waiver-pollen-dactylis-glomarata-16-lolium-perenne-16-phleum-pratense-16_en.pdf"},
    {"id":"7028","name":"P/0190/2014: EMA decision of 6 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ Cells Transduced ex-vivo with Retroviral Vector (GIADAl) Containing Human Ade...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/391460/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2014-ema-decision-6-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-cells-transduced-ex-vivo-retroviral-vector-giadal-containing-human-ade_en.pdf"},
    {"id":"7034","name":"P/0123/2014: EMA decision of 8 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation Factor VIII / von Willebrand Factor (Voncento), (EMEA-000312-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-11T16:00:00Z","last_updated_date":"2014-06-11T16:00:00Z","reference_number":"EMA/182183/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2014-ema-decision-8-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-voncento-emea-000312-pip01-08-m06_en.pdf"},
    {"id":"7042","name":"P/0064/2014: European Medicines Agency decision of 7 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for nivolumab (EMEA-001407-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/103630/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2014-european-medicines-agency-decision-7-march-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-nivolumab-emea-001407-pip01-12_en.pdf"},
    {"id":"7066","name":"P/0053/2012: EMA decision of 23 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lisdexamfetamine\n\n(dimesylate) (EMEA-000553-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T17:42:00Z","last_updated_date":"2012-04-20T17:42:00Z","reference_number":"EMA/195952/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2012-ema-decision-23-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-lisdexamfetamine-dimesylate-emea-000553-pip01-09-m03_en.pdf"},
    {"id":"7083","name":"P/0284/2013: EMA decision of 8 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-12-06T01:00:00Z","last_updated_date":"2013-12-06T01:00:00Z","reference_number":"EMA/648110/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0284-2013-ema-decision-8-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"7095","name":"P/0203/2016: EMA decision of 22 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for quizartinib (EMEA-001821-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/507354/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2016-ema-decision-22-july-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-quizartinib-emea-001821-pip01-15_en.pdf"},
    {"id":"7103","name":"P/119/2010: European Medicines Agency decision of 9 July 2010\n\non the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M01) in accordance with Regulat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/349760/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-119-2010-european-medicines-agency-decision-9-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-telbivudine-sebivo-emea-000065-pip01-07-m01-accordance-regulat_en.pdf"},
    {"id":"7111","name":"P/0399/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen /\n\nhuman thrombin (Evicel, Evarrest) (EMEA-001149-PIP01-11-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T11:48:00Z","last_updated_date":"2018-03-02T11:48:00Z","reference_number":"EMA/759119/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0399-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-human-thrombin-evicel-evarrest-emea-001149-pip01-11-m04_en.pdf"},
    {"id":"7123","name":"P/0367/2017: EMA decision of 1 December 2017 on the refusal of a product specific waiver for human neutrophil elastase inhibitor (CHF6333)\n\n(EMEA-002196-PIP01-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T14:03:00Z","last_updated_date":"2018-03-07T14:03:00Z","reference_number":"EMA/723579/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0367-2017-ema-decision-1-december-2017-refusal-product-specific-waiver-human-neutrophil-elastase-inhibitor-chf6333-emea-002196-pip01-17_en.pdf"},
    {"id":"7141","name":"P/0123/2016: EMA decision of 12 May 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for darunavir / cobicistat / emtricitabine / tenofovir alafen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/287464/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2016-ema-decision-12-may-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-darunavir-cobicistat-emtricitabine-tenofovir-alafen_en.pdf"},
    {"id":"7148","name":"P/0068/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan, Thymanax) (EMEA-001181-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/160746/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-agomelatine-valdoxan-thymanax-emea-001181-pip01-11-m02_en.pdf"},
    {"id":"7150","name":"P/138/2009: European Medicines Agency decision of 15 July 2009 on the granting of a product specific waiver for omacetaxine mepesuccinate (EMEA-000484-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Euro...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/416511/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-138-2009-european-medicines-agency-decision-15-july-2009-granting-product-specific-waiver-omacetaxine-mepesuccinate-emea-000484-pip01-08-accordance-regulation-ec-no-1901-2006-euro_en.pdf"},
    {"id":"7170","name":"P/0132/2015: EMA decision of 12 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-07T02:00:00Z","last_updated_date":"2015-07-07T02:00:00Z","reference_number":"EMA/364986/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2015-ema-decision-12-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip01-07-m05_en.pdf"},
    {"id":"7177","name":"P/0265/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for Guanfacine (hydrochloride) (EMEA-000745-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/85737/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-guanfacine-hydrochloride-emea-000745-pip01-09-m03_en.pdf"},
    {"id":"7183","name":"P/0163/2012: EMA decision of 23 July 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for misoprostol (EMEA-001159-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T13:00:00Z","last_updated_date":"2012-08-23T13:00:00Z","reference_number":"EMA/475432/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2012-ema-decision-23-july-2012-agreement-paediatric-investigation-plan-granting-waiver-misoprostol-emea-001159-pip02-12_en.pdf"},
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    {"id":"7196","name":"P/0269/2014: EMA decision of 27 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion protein linking human coagulation factor IX with human albumin (EMEA-0011...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-09T01:00:00Z","last_updated_date":"2014-12-09T01:00:00Z","reference_number":"EMA/591163/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2014-ema-decision-27-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-linking-human-coagulation-factor-ix-human-albumin-emea-0011_en.pdf"},
    {"id":"7206","name":"P/84/2008: European medicines agency decision of of 14 October 2008 \n\non the application for agreement of a Paediatric Investigation Plan for valsartan (Diovan) (EMEA-000005-PIP01-07) in accordance with Regulation (EC) N...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/522876/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-84-2008-european-medicines-agency-decision-14-october-2008-application-agreement-paediatric-investigation-plan-valsartan-diovan-emea-000005-pip01-07-accordance-regulation-ec-n_en.pdf"},
    {"id":"7231","name":"P/0013/2018: EMA decision of 26 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil\n\n(Zinforo) (EMEA-000769-PIP01-09-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T11:41:00Z","last_updated_date":"2018-04-18T11:41:00Z","reference_number":"EMA/28040/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2018-ema-decision-26-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-zinforo-emea-000769-pip01-09-m07_en.pdf"},
    {"id":"7235","name":"P/48/2012: EMA decision of 29 February 2012 on the agreement of a paediatric investigation plan for recombinant human A disintegrin and metalloprotease with thrombospind type-1 motifs 13 (EMEA-001160-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/PDCO/54526/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-48-2012-ema-decision-29-february-2012-agreement-paediatric-investigation-plan-recombinant-human-disintegrin-metalloprotease-thrombospind-type-1-motifs-13-emea-001160-pip01-11_en.pdf"},
    {"id":"7237","name":"P/0245/2013: EMA decision of 4 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin (EMEA-000016-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/588205/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2013-ema-decision-4-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-dalbavancin-emea-000016-pip01-07-m02_en.pdf"},
    {"id":"7254","name":"P/0204/2013: EMA decision of 3 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for modified grass-pollen extract (EMEA-000284-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/476174/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2013-ema-decision-3-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-modified-grass-pollen-extract-emea-000284-pip01-08-m04_en.pdf"},
    {"id":"7258","name":"P/63/2009: European Medicines Agency decision of 27 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for sitagliptin phosphate monohydrate (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/174961/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-63-2009-european-medicines-agency-decision-27-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sitagliptin-phosphate-monohydrate_en.pdf"},
    {"id":"7281","name":"P/0230/2015: EMA decision of 22 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for vaborbactam (in combination with meropenem trihydrate) (EMEA-001740-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2015-12-22T13:00:00Z","reference_number":"EMA/624852/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2015-ema-decision-22-october-2015-agreement-paediatric-investigation-plan-granting-deferral-vaborbactam-combination-meropenem-trihydrate-emea-001740-pip01-14_en.pdf"},
    {"id":"7283","name":"P/0021/2012: EMA decision of 27 January 2012 on the agreement of a paediatric investigation plan for cyclophosphamide (EMEA-000530-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/985495/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2012-ema-decision-27-january-2012-agreement-paediatric-investigation-plan-cyclophosphamide-emea-000530-pip02-11_en.pdf"},
    {"id":"7287","name":"P/73/2009: European Medicines Agency decision of 20 April 2009 on the agreement of a Paediatric Investigation Plan for mercaptopurine monohydrate (EMEA-000350-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2009-06-10T02:00:00Z","reference_number":"EMEA/233188/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-73-2009-european-medicines-agency-decision-20-april-2009-agreement-paediatric-investigation-plan-mercaptopurine-monohydrate-emea-000350-pip01-08-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"7308","name":"P/254/2011: EMA decision of 26 October 2011 on the granting of a product specific waiver for pancreas powder (EMEA-000287-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/776844/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-254-2011-ema-decision-26-october-2011-granting-product-specific-waiver-pancreas-powder-emea-000287-pip02-10_en.pdf"},
    {"id":"7324","name":"P/175/2010: European Medicines Agency decision of 20 September 2010 on the granting of a product specific waiver for (R)-3(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/547271/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-175-2010-european-medicines-agency-decision-20-september-2010-granting-product-specific-waiver-r-34-7h-pyrrolo23-dpyrimidin-4-yl-1h-pyrazol-1-yl-3-cyclopentylpropanenitrilephosphate-emea-0_en.pdf"},
    {"id":"7344","name":"P/0149/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for human recombinant IgG1 monoclonal antibody targeting fibroblast growth factor 23 (KRN23) (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/305257/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-human-recombinant-igg1-monoclonal-antibody-targeting-fibroblast-growth-factor-23-krn23-emea-0_en.pdf"},
    {"id":"7395","name":"P/0188/2014: EMA decision of 6 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation factor X (EMEA-000971-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/447727/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2014-ema-decision-6-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-x-emea-000971-pip01-10-m02_en.pdf"},
    {"id":"7431","name":"P/272/2010: EMA decision of 29 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for eritoran (EMEA-\n\n000509-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-10T01:00:00Z","last_updated_date":"2011-01-10T01:00:00Z","reference_number":"EMA/757016/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-272-2010-ema-decision-29-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-eritoran-emea-000509-pip02-09-m02_en.pdf"},
    {"id":"7454","name":"P/194/2011: EMA decision of 3 August 2011 on the granting of a product specific waiver for recombinant salmon calcitonin (EMEA-000092-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/593331/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-194-2011-ema-decision-3-august-2011-granting-product-specific-waiver-recombinant-salmon-calcitonin-emea-000092-pip02-11_en.pdf"},
    {"id":"7458","name":"P/0093/2015: EMA decision of 8 May 2015 on the refusal of a paediatric investigation plan and on the granting of a waiver for masitinib (mesylate) (EMEA-001266-PIP02-14)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/215125/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2015-ema-decision-8-may-2015-refusal-paediatric-investigation-plan-granting-waiver-masitinib-mesylate-emea-001266-pip02-14_en.pdf"},
    {"id":"7464","name":"P/0162/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP02-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/446651/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip02-10-m06_en.pdf"},
    {"id":"7478","name":"P/95/2011: EMA decision of 4 April 2011 on the granting of a product specific waiver for ezetimibe/simvastatin (Inegy and associated names)\n\n(EMEA-000006-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/247674/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-95-2011-ema-decision-4-april-2011-granting-product-specific-waiver-ezetimibe-simvastatin-inegy-associated-names-emea-000006-pip02-10_en.pdf"},
    {"id":"7502","name":"P/0160/2012: EMA decision of 25 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 7-[4-(4-Benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]quino...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T18:30:00Z","last_updated_date":"2012-10-08T11:50:00Z","reference_number":"EMA/458409/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2012-ema-decision-25-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-7-4-4-benzobthiophen-4-ylpiperazin-1-ylbutoxyquino_en.pdf"},
    {"id":"7514","name":"P/0279/2014: EMA decision of 28 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-09T01:00:00Z","last_updated_date":"2014-12-09T01:00:00Z","reference_number":"EMA/590270/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0279-2014-ema-decision-28-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-neisseria-meningitidis-serogroup-b-recombinant-lipoprotein-rlp2086-subfamily-escherichi_en.pdf"},
    {"id":"7521","name":"P/0135/2012: EMA decision of 20 July 2012 on the granting of a product specific waiver for ezetimibe (Ezetrol and associated names) (EMEA-\n\n000007-PIP04-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T17:15:00Z","last_updated_date":"2012-08-22T17:15:00Z","reference_number":"EMA/452159/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2012-ema-decision-20-july-2012-granting-product-specific-waiver-ezetimibe-ezetrol-associated-names-emea-000007-pip04-12_en.pdf"},
    {"id":"7533","name":"P/156/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (EMEA-\n\n000116-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/513798/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-156-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-retigabine-emea-000116-pip01-07-m04_en.pdf"},
    {"id":"7556","name":"P/0196/2012: EMA decision of 24 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for fibrinogen (human\n\nplasma-derived), (EMEA-000457-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/533974/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2012-ema-decision-24-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-fibrinogen-human-plasma-derived-emea-000457-pip02-10-m01_en.pdf"},
    {"id":"7561","name":"P/121/2009: European Medicines Agency decision of 15 June 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for dienogest / ethinylestradiol (as betadex clathrate) / L-5-methyltetrahy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351771/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-121-2009-european-medicines-agency-decision-15-june-2009-refusal-paediatric-investigation-plan-granting-waiver-dienogest-ethinylestradiol-betadex-clathrate-l-5-methyltetrahy_en.pdf"},
    {"id":"7569","name":"P/0210/2014: EMA decision of 12 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for silicic acid, sodium zirconium (4+) salt (3:2:1) hydrate (EMEA-001539-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/391489/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2014-ema-decision-12-august-2014-agreement-paediatric-investigation-plan-granting-deferral-silicic-acid-sodium-zirconium-4-salt-321-hydrate-emea-001539-pip01-13_en.pdf"},
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    {"id":"7591","name":"P/0315/2014: EMA decision of 5 December 2014 on the granting of a product specific waiver for amlodipine (besylate) / valsartan (Exforge), (EMEA-001680-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/668036/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0315-2014-ema-decision-5-december-2014-granting-product-specific-waiver-amlodipine-besylate-valsartan-exforge-emea-001680-pip01-14_en.pdf"},
    {"id":"7593","name":"P/242/2010: EMA decision of 16 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pixantrone (000713-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/703753/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-242-2010-ema-decision-16-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pixantrone-000713-pip02-10_en.pdf"},
    {"id":"7608","name":"P/0008/2012: EMA decision of 24 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for telaprevir (Incivo),\n\n(EMEA-000196-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-03-14T16:45:00Z","reference_number":"EMA/973114/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2012-ema-decision-24-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-telaprevir-incivo-emea-000196-pip01-08-m01_en.pdf"},
    {"id":"7650","name":"P/165/2009: European Medicines Agency decision of 14 August 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for human normal immunoglobulin (Gamm...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/493745/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-165-2009-european-medicines-agency-decision-14-august-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-normal-immunoglobulin-gamm_en.pdf"},
    {"id":"7659","name":"P/0110/2016: EMA decision of 15 April 2016 on the granting of a product specific waiver for Gallium [68Ga] (EMEA-001842-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/188353/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2016-ema-decision-15-april-2016-granting-product-specific-waiver-gallium-68ga-emea-001842-pip02-15_en.pdf"},
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    {"id":"7699","name":"P/10/2011:  EMA decision of 3 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pollen from betula pendula, (EMEA-000853-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/683406/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-10-2011-ema-decision-3-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-betula-pendula-emea-000853-pip01-10_en.pdf"},
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    {"id":"7782","name":"P/111/2010: European Medicines Agency decision of 6 July 2010\n\non the refusal of a paediatric investigation plan and on the granting of a waiver for tulobuterol (EMEA-000763-PIP01-09) in accordance with Regulation (EC) N...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/409589/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-111-2010-european-medicines-agency-decision-6-july-2010-refusal-paediatric-investigation-plan-granting-waiver-tulobuterol-emea-000763-pip01-09-accordance-regulation-ec-n_en.pdf"},
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    {"id":"7793","name":"P/0251/2013: EMA decision of 29 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Afinitor, Certican and associated names), (EMEA-000019-PIP06-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/598169/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2013-ema-decision-29-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-afinitor-certican-associated-names-emea-000019-pip06-09-m04_en.pdf"},
    {"id":"7809","name":"P/0216/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tafluprost (Taflotan and associated names) (EMEA-001187-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/591158/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-tafluprost-taflotan-associated-names-emea-001187-pip01-11-m02_en.pdf"},
    {"id":"7821","name":"P/67/2009: European Medicines Agency decision of 20 April 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for Dihydroartemisinin / Piperaquine ph...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2009-06-10T02:00:00Z","reference_number":"EMEA/23353/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-67-2009-european-medicines-agency-decision-20-april-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dihydroartemisinin-piperaquine-ph_en.pdf"},
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    {"id":"7834","name":"P/0008/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aprepitant (Emend) (EMEA-000144-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/10425/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-aprepitant-emend-emea-000144-pip01-07-m05_en.pdf"},
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    {"id":"7939","name":"P/0255/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for grazoprevir / elbasvir (Zepatier), (EMEA-001604-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/501661/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0255-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-grazoprevir-elbasvir-zepatier-emea-001604-pip01-13-m03_en.pdf"},
    {"id":"7972","name":"P/77/2010: European Medicines Agency decision of 7 May 2010 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000167-PIP01-07-M01) in accordance with Reg...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/261382/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-77-2010-european-medicines-agency-decision-7-may-2010-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000167-pip01-07-m01-accordance-reg_en.pdf"},
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    {"id":"7990","name":"P/101/2008: European Medicines Agency decision of 3 November 2008 on the application for product specific waiver for influenza virus type A, H3N2, influenza virus type A, H1N1, influenza virus type B (EMEA-000249-PIP01-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-07T01:00:00Z","last_updated_date":"2009-01-07T01:00:00Z","reference_number":"EMEA/572430/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-101-2008-european-medicines-agency-decision-3-november-2008-application-product-specific-waiver-influenza-virus-type-h3n2-influenza-virus-type-h1n1-influenza-virus-type-b-emea-000249-pip01-0_en.pdf"},
    {"id":"8004","name":"P/0268/2017: EMA decision of 7 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for avacopan\n\n(EMEA-002023-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/541695/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2017-ema-decision-7-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-avacopan-emea-002023-pip01-16-m01_en.pdf"},
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    {"id":"8024","name":"P/0028/2012: EMA decision of 27 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for imatinib mesilate\n\n(Glivec) (EMEA-000463-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/36974/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2012-ema-decision-27-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-imatinib-mesilate-glivec-emea-000463-pip01-08-m03_en.pdf"},
    {"id":"8047","name":"P/0072/2017: EMA decision of 17 March 2017 on the granting of a product specific waiver for 5-(4-cyclopropyl-1H-imidazol-1-yl)-2-fluoro-N-(6-(4-\n\nisopropyl-4H-1,2,4-triazol-3-yl)pyridi-2-yl)-4-methylbenzamide (EMEA-00186...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/137095/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2017-ema-decision-17-march-2017-granting-product-specific-waiver-5-4-cyclopropyl-1h-imidazol-1-yl-2-fluoro-n-6-4-isopropyl-4h-124-triazol-3-ylpyridi-2-yl-4-methylbenzamide-emea-00186_en.pdf"},
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    {"id":"8122","name":"P/0204/2016: EMA decision of 1 August 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pembrolizumab (Keytruda), (EMEA-001474-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/508723/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2016-ema-decision-1-august-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pembrolizumab-keytruda-emea-001474-pip02-16_en.pdf"},
    {"id":"8153","name":"P/190/2011: EMA decision of 2 August 2011 on the granting of a product specific waiver for amlodipine (besilate) / valsartan (EMEA-001138-PIP02-\n\n11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/500415/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-190-2011-ema-decision-2-august-2011-granting-product-specific-waiver-amlodipine-besilate-valsartan-emea-001138-pip02-11_en.pdf"},
    {"id":"8160","name":"P/0038/2017: European Medicines Agency decision of 30 January 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for ambrisentan / tadalafil (EMEA-0020...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/2910/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0038-2017-european-medicines-agency-decision-30-january-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-ambrisentan-tadalafil-emea-0020_en.pdf"},
    {"id":"8165","name":"P/49/2009: European Medicines Agency decision of 24 March 2009 on the refusal of a product specific waiver for melatonin (Circadin) (EMEA-000440-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/156983/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-49-2009-european-medicines-agency-decision-24-march-2009-refusal-product-specific-waiver-melatonin-circadin-emea-000440-pip01-08-accordance-regulation-ec-no-1901-2006-european-p_en.pdf"},
    {"id":"8184","name":"P/0233/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for romiplostim (Nplate), (EMEA-000653-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/460032/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-romiplostim-nplate-emea-000653-pip01-09-m05_en.pdf"},
    {"id":"8195","name":"P/0042/2013: European medicines agency decision of 1 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for cilengitide (EMEA-000550-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/117801/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2013-european-medicines-agency-decision-1-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-cilengitide-emea-000550-pip02-10-m01_en.pdf"},
    {"id":"8213","name":"P/0181/2012: EMA decision of 20 August 2012 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-001278-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/480335/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2012-ema-decision-20-august-2012-granting-product-specific-waiver-rosuvastatin-ezetimibe-emea-001278-pip01-12_en.pdf"},
    {"id":"8219","name":"P/0114/2017: EMA decision of 11 April 2017 on the granting of a product specific waiver for tobramycin (TOBI Podhaler) (EMEA-000184-PIP03-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/199884/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0114-2017-ema-decision-11-april-2017-granting-product-specific-waiver-tobramycin-tobi-podhaler-emea-000184-pip03-16_en.pdf"},
    {"id":"8229","name":"P/0303/2014: EMA decision of 24 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion protein consisting of human coagulation factor IX attached to the Fc dom...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/640510/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0303-2014-ema-decision-24-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-consisting-human-coagulation-factor-ix-attached-fc-dom_en.pdf"},
    {"id":"8230","name":"P/0173/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for colistimethate sodium (Colobreathe), (EMEA-000176-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/357972/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2017-ema-decision-3-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-colistimethate-sodium-colobreathe-emea-000176-pip01-07-m05_en.pdf"},
    {"id":"8233","name":"P/136/2010:  European Medicines Agency decision of 28 July 2010 on the granting of a product specific waiver for amlodipine/ramipril (EMEA-000887-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/464681/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-136-2010-european-medicines-agency-decision-28-july-2010-granting-product-specific-waiver-amlodipine-ramipril-emea-000887-pip01-10-accordance-regulation-ec-no-1901-2006-european_en.pdf"},
    {"id":"8239","name":"P/214/2010: European Medicines Agency decision of 29 October 2010 on the granting of a product specific waiver for dronabinol (EMEA-000643-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/655072/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-214-2010-european-medicines-agency-decision-29-october-2010-granting-product-specific-waiver-dronabinol-emea-000643-pip01-09_en.pdf"},
    {"id":"8244","name":"P/0128/2015: EMA decision of 5 June 2015 on the refusal of a product-specific waiver for levomilnacipran (EMEA-001724-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/355186/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0128-2015-ema-decision-5-june-2015-refusal-product-specific-waiver-levomilnacipran-emea-001724-pip01-14_en.pdf"},
    {"id":"8260","name":"P/322/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for cysteamine hydrochloride (EMEA-000322-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/790256/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-322-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-cysteamine-hydrochloride-emea-000322-pip01-08-m04_en.pdf"},
    {"id":"8264","name":"P/333/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for aqueous allergen extract of grass and cereal pollen ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/815111/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-333-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aqueous-allergen-extract-grass-cereal-pollen_en.pdf"},
    {"id":"8277","name":"P/0083/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tralokinumab (EMEA-001900-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/75601/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tralokinumab-emea-001900-pip02-17_en.pdf"},
    {"id":"8286","name":"P/0004/2016: EMA decision of 22 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa (Ruconest), (EMEA-000367-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/864426/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2016-ema-decision-22-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-conestat-alfa-ruconest-emea-000367-pip01-08-m05_en.pdf"},
    {"id":"8295","name":"P/0178/2013: EMA decision of 30 July 2013 on the granting of a product-specific waiver for pegylated proline-interferon alpha-2b (EMEA-001433-\n\nPIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/367827/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2013-ema-decision-30-july-2013-granting-product-specific-waiver-pegylated-proline-interferon-alpha-2b-emea-001433-pip01-13_en.pdf"},
    {"id":"8304","name":"P/293/2011: EMA decision of 8 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for nonacog alfa\n\n(recombinant coagulation factor IX) (EMEA-001139-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/878747/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-293-2011-ema-decision-8-december-2011-agreement-paediatric-investigation-plan-granting-deferral-nonacog-alfa-recombinant-coagulation-factor-ix-emea-001139-pip01-11_en.pdf"},
    {"id":"8305","name":"P/0050/2018: EMA decision of 22 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo),\n\n(EMEA-001407-PIP02-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/101775/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2018-ema-decision-22-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-nivolumab-opdivo-emea-001407-pip02-15-m02_en.pdf"},
    {"id":"8307","name":"P/0201/2013: EMA decision of 2 September 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for retosiban (EMEA-001359-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"EMA/482792/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2013-ema-decision-2-september-2013-agreement-paediatric-investigation-plan-granting-waiver-retosiban-emea-001359-pip01-12_en.pdf"},
    {"id":"8364","name":"P/0253/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat / emtricitabine / tenofovir alafenamide (EMEA-001825-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/493101/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0253-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-darunavir-cobicistat-emtricitabine-tenofovir-alafenamide-emea-001825-pip01-15-m01_en.pdf"},
    {"id":"8380","name":"P/8/2011:  EMA decision of 3 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pollen from pollen from alnus glutinosa, betula verrucos...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/753493/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-8-2011-ema-decision-3-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-pollen-alnus-glutinosa-betula-verrucos_en.pdf"},
    {"id":"8448","name":"P/0136/2017: EMA decision of 7 June 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cannabidiol (CBD) (EMEA-001964-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/312728/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2017-ema-decision-7-june-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cannabidiol-cbd-emea-001964-pip01-16_en.pdf"},
    {"id":"8524","name":"P/256/2011: EMA decision of 26 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (EMEA-000769-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T17:00:00Z","last_updated_date":"2011-11-30T17:00:00Z","reference_number":"EMA/829145/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-256-2011-ema-decision-26-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-emea-000769-pip01-09-m01_en.pdf"},
    {"id":"8533","name":"P/0103/2018: EMA decision of 19 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for plazomicin (sulfate) (EMEA-001639-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/156109/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2018-ema-decision-19-march-2018-agreement-paediatric-investigation-plan-granting-deferral-plazomicin-sulfate-emea-001639-pip02-17_en.pdf"},
    {"id":"8540","name":"P/0052/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime / avibactam (EMEA-001313-PIP01-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/133540/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0052-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-ceftazidime-avibactam-emea-001313-pip01-12-m03_en.pdf"},
    {"id":"8545","name":"P/0275/2017: EMA decision of 4 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for roxadustat (EMEA-\n\n001557-PIP01-13-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-02-16T01:00:00Z","last_updated_date":"2018-02-16T01:00:00Z","reference_number":"EMA/565803/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0275-2017-ema-decision-4-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-roxadustat-emea-001557-pip01-13-m01_en.pdf"},
    {"id":"8565","name":"P/0191/2013: EMA decision of 9 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga) (EMEA-000597-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-10T12:20:00Z","last_updated_date":"2013-09-10T12:20:00Z","reference_number":"EMA/476084/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2013-ema-decision-9-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip02-10-m01_en.pdf"},
    {"id":"8599","name":"P/0275/2012: EMA decision of of 21 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (EMEA-000454-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/727269/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0275-2012-ema-decision-21-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000454-pip01-08-m02_en.pdf"},
    {"id":"8643","name":"P/154/2010: EMA decision of 17 March 2010 on the acceptance of a modification of an agreed paediatric investigation plan for boceprevir\n\n(EMEA-000583-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-07T02:00:00Z","last_updated_date":"2010-10-07T02:00:00Z","reference_number":"EMA/525486/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-154-2010-ema-decision-17-march-2010-acceptance-modification-agreed-paediatric-investigation-plan-boceprevir-emea-000583-pip01-09-m01_en.pdf"},
    {"id":"8657","name":"P/0045/2018: EMA decision of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco) (EMEA-000335-PIP01-08-M12)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T13:35:00Z","last_updated_date":"2018-04-17T13:35:00Z","reference_number":"EMA/85241/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2018-ema-decision-16-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m12_en.pdf"},
    {"id":"8660","name":"P/0273/2016: EMA decision of 5 October 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for recombinant, CHO cell expressed, fully human IgG1, ka...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/592953/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0273-2016-ema-decision-5-october-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-cho-cell-expressed-fully-human-igg1-ka_en.pdf"},
    {"id":"8714","name":"P/216/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a product specific waiver for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized allergic extract of birch pollen (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/679780/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-216-2009-european-medicines-agency-decision-30-october-2009-refusal-product-specific-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerized-allergic-extract-birch-pollen-eme_en.pdf"},
    {"id":"8727","name":"P/0112/2016: EMA decision of 15 April 2016 on the granting of a product specific waiver for Atorvastatin / Perindopril (arginine) (EMEA-001876-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/199336/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2016-ema-decision-15-april-2016-granting-product-specific-waiver-atorvastatin-perindopril-arginine-emea-001876-pip01-15_en.pdf"},
    {"id":"8764","name":"P/0146/2014: EMA decision of 13 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine (Valdoxan, Thymanax), (EMEA-001181-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-28T02:00:00Z","last_updated_date":"2014-07-28T02:00:00Z","reference_number":"EMA/319518/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0146-2014-ema-decision-13-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-agomelatine-valdoxan-thymanax-emea-001181-pip01-11-m01_en.pdf"},
    {"id":"8778","name":"P/0262/2015: EMA decision of 30 October 2015 on the granting of a product specific waiver for 18F-fluoroestradiol (EMEA-001817-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2015-12-22T13:00:00Z","reference_number":"EMA/627027/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0262-2015-ema-decision-30-october-2015-granting-product-specific-waiver-18f-fluoroestradiol-emea-001817-pip01-15_en.pdf"},
    {"id":"8801","name":"P/173/2011: EMA decision of 8 July 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant\n\nfusion protein consisting of Human Coagulation Factor VIII attached to the Fc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/491168/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-173-2011-ema-decision-8-july-2011-agreement-paediatric-investigation-plan-granting-deferral-recombinant-fusion-protein-consisting-human-coagulation-factor-viii-attached-fc_en.pdf"},
    {"id":"8804","name":"P/0112/2013: EMA decision of 30 April 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant human lysosomal acid lipase (EMEA-001331-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203353/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2013-ema-decision-30-april-2013-agreement-paediatric-investigation-plan-granting-deferral-recombinant-human-lysosomal-acid-lipase-emea-001331-pip01-12_en.pdf"},
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    {"id":"8850","name":"P/0058/2013: European medicines agency decision of 26 March 2013 on the refusal of a modification of an agreed paediatric investigation plan for everolimus (Votubia), (EMEA-000019-PIP02-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/111742/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2013-european-medicines-agency-decision-26-march-2013-refusal-modification-agreed-paediatric-investigation-plan-everolimus-votubia-emea-000019-pip02-07-m04_en.pdf"},
    {"id":"8860","name":"P/0334/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen (EMEA-001208-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T01:00:00Z","last_updated_date":"2015-02-23T01:00:00Z","reference_number":"EMA/711021/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0334-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-emea-001208-pip01-11-m01_en.pdf"},
    {"id":"8884","name":"P/270/2011: EMA decision of 28 October 2011 on the granting of a product specific waiver for clopidogrel (bisulphate) / acetylsalicylic acid (EMEA-\n\n001163-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/849727/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-270-2011-ema-decision-28-october-2011-granting-product-specific-waiver-clopidogrel-bisulphate-acetylsalicylic-acid-emea-001163-pip01-11_en.pdf"},
    {"id":"8896","name":"P/260/2011: EMA decision of 28 October 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for secretin (EMEA-001069-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/776844/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-260-2011-ema-decision-28-october-2011-agreement-paediatric-investigation-plan-granting-deferral-secretin-emea-001069-pip01-10_en.pdf"},
    {"id":"8916","name":"P/0043/2014: European Medicines Agency decision of 26 February 2014\n\non the acceptance of a modification of an agreed paediatric investigation plan for rupadatine fumarate (Rupafin and associated names) (EMEA-000582-PIP0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-03-20T01:00:00Z","last_updated_date":"2014-03-20T01:00:00Z","reference_number":"EMA/87776/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2014-european-medicines-agency-decision-26-february-2014-acceptance-modification-agreed-paediatric-investigation-plan-rupadatine-fumarate-rupafin-associated-names-emea-000582-pip0_en.pdf"},
    {"id":"8927","name":"P/133/2009: European Medicines Agency decision of 15 July 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for insulin glargine (Lantus) (EMEA-000387-PIP01-08) in accordance with R...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/387927/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-133-2009-european-medicines-agency-decision-15-july-2009-agreement-paediatric-investigation-plan-granting-waiver-insulin-glargine-lantus-emea-000387-pip01-08-accordance-r_en.pdf"},
    {"id":"8994","name":"P/0238/2014: EMA decision of 19 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tap...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-10-09T02:00:00Z","last_updated_date":"2014-10-09T02:00:00Z","reference_number":"EMA/555779/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0238-2014-ema-decision-19-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tap_en.pdf"},
    {"id":"9007","name":"P/0233/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ixekizumab (Taltz),\n\n(EMEA-001050-PIP01-10-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/576562/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2016-ema-decision-9-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-ixekizumab-taltz-emea-001050-pip01-10-m02_en.pdf"},
    {"id":"9051","name":"P/0102/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ferric maltol\n\n(Feraccru), (EMEA-001195-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/202479/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-ferric-maltol-feraccru-emea-001195-pip01-11-m02_en.pdf"},
    {"id":"9053","name":"P/09/2009: European Medicines Agency decision of 27 January 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for ceftobiprole medocaril sodium (EMEA-000205-PIP01-08) in accordanc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/23291/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-09-2009-european-medicines-agency-decision-27-january-2009-agreement-paediatric-investigation-plan-granting-deferral-ceftobiprole-medocaril-sodium-emea-000205-pip01-08-accordanc_en.pdf"},
    {"id":"9055","name":"P/0134/2012: EMA decision of 6 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto) (EMEA-000430-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/430103/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0134-2012-ema-decision-6-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m03_en.pdf"},
    {"id":"9068","name":"P/0149/2012: EMA decision of 24 July 2012 on the refusal of a product specific waiver for tivantinib (EMEA-001284-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T18:30:00Z","last_updated_date":"2012-08-22T18:30:00Z","reference_number":"EMA/470735/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2012-ema-decision-24-july-2012-refusal-product-specific-waiver-tivantinib-emea-001284-pip01-12_en.pdf"},
    {"id":"9078","name":"P/0265/2014: EMA decision of 10 October 2014 on the refusal of a modification of an agreed paediatric investigation plan for dihydroartemisinin / piperaquine phosphate anhydride (EMEA-000153-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/590274/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2014-ema-decision-10-october-2014-refusal-modification-agreed-paediatric-investigation-plan-dihydroartemisinin-piperaquine-phosphate-anhydride-emea-000153-pip01-07-m02_en.pdf"},
    {"id":"9086","name":"P/0083/2012: EMA decision of 16 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for belatacept (Nulojix) (EMEA-000157-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/304247/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2012-ema-decision-16-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-belatacept-nulojix-emea-000157-pip01-07-m01_en.pdf"},
    {"id":"9093","name":"P/0120/2017: EMA decision of 5 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol hydrochloride) (Palexia and associated names, Yantil and associated names, Tapentadol ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/244179/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2017-ema-decision-5-may-2017-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapentadol_en.pdf"},
    {"id":"9128","name":"P/0002/2012: EMA decision of 23 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract from ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/972929/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2012-ema-decision-23-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract_en.pdf"},
    {"id":"9152","name":"P/0030/2017: European Medicines Agency decision of 31 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for 2-hydroxypropyl-àŸ-cyclodextrin (EMEA-001866-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/12304/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2017-european-medicines-agency-decision-31-january-2017-agreement-paediatric-investigation-plan-granting-deferral-2-hydroxypropyl-ay-cyclodextrin-emea-001866-pip01-15_en.pdf"},
    {"id":"9175","name":"P/26/2010: European Medicines Agency decision of of 3 March 2010 on the acceptance of a modification of an agreed Paediatric Investigation Plan for nevirapine (Viramune) (EMEA-000391-PIP01-08-M01) in accordance with Regu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-04-19T02:00:00Z","last_updated_date":"2010-04-19T02:00:00Z","reference_number":"EMA/116975/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-26-2010-european-medicines-agency-decision-3-march-2010-acceptance-modification-agreed-paediatric-investigation-plan-nevirapine-viramune-emea-000391-pip01-08-m01-accordance-regu_en.pdf"},
    {"id":"9178","name":"P/0015/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for regadenoson\n\n(Rapiscan) (EMEA-000410-PIP01-08-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T15:28:00Z","last_updated_date":"2018-04-17T15:28:00Z","reference_number":"EMA/792962/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-regadenoson-rapiscan-emea-000410-pip01-08-m02_en.pdf"},
    {"id":"9182","name":"P/0172/2016: EMA decision of 17 June 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Influenza virus surface antigens of strain A (H3N2) / st...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/337108/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2016-ema-decision-17-june-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-surface-antigens-strain-h3n2-st_en.pdf"},
    {"id":"9199","name":"P/0006/2012: EMA decision of 24 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Afinitor), (Certican and associated names), (EMEA-000019-PIP06-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/25160/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2012-ema-decision-24-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-afinitor-certican-associated-names-emea-000019-pip06-09-m02_en.pdf"},
    {"id":"9245","name":"P/0148/2016: EMA decision of 14 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for melatonin (Circadin)\n\n(EMEA-000440-PIP02-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/380534/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2016-ema-decision-14-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-melatonin-circadin-emea-000440-pip02-11-m04_en.pdf"},
    {"id":"9255","name":"P/0073/2017: EMA decision of 17 March 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for 8-chloro-5-methyl-1-[trans-4-(pyridin-2-yloxy)cyclohex...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/137097/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2017-ema-decision-17-march-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-8-chloro-5-methyl-1-trans-4-pyridin-2-yloxycyclohex_en.pdf"},
    {"id":"9260","name":"P/139/2011: EMA decision of 1 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for mipomersen (sodium) (EMEA-000928-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-13T02:00:00Z","last_updated_date":"2011-07-13T02:00:00Z","reference_number":"EMA/425115/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-139-2011-ema-decision-1-june-2011-acceptance-modification-agreed-paediatric-investigation-plan-mipomersen-sodium-emea-000928-pip01-10-m01_en.pdf"},
    {"id":"9266","name":"P/0218/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol\n\n(hydrochloride) (Palexia, Yantil), (EMEA-000018-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/598557/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-yantil-emea-000018-pip01-07-m04_en.pdf"},
    {"id":"9269","name":"P/0232/2015: EMA decision of 27 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine / rilpivirine (hydrochloride) / tenofovir (disoproxil fumarate), (Eviplera), (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/619851/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2015-ema-decision-27-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-emtricitabine-rilpivirine-hydrochloride-tenofovir-disoproxil-fumarate-eviplera_en.pdf"},
    {"id":"9270","name":"P/0033/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for house dust mites allergen extracts (EMEA-000319-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/49374/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-house-dust-mites-allergen-extracts-emea-000319-pip01-08-m03_en.pdf"},
    {"id":"9290","name":"P/0021/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-001797-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/850458/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-001797-pip01-15-m01_en.pdf"},
    {"id":"9306","name":"P/0172/2014: EMA decision of 11 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin detemir (Levemir), (EMEA-000412-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/314402/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2014-ema-decision-11-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-insulin-detemir-levemir-emea-000412-pip01-08-m01_en.pdf"},
    {"id":"9310","name":"P/0092/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapenta...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/188340/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapenta_en.pdf"},
    {"id":"9341","name":"P/0191/2014: EMA decision of 6 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrah...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/447544/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2014-ema-decision-6-august-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-n-13-dicyclohexyl-6-hydroxy-24-dioxo-1234-tetrah_en.pdf"},
    {"id":"9348","name":"P/0233/2012: EMA decision of 5 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Pitavastatin and associated names), (EMEA-000302-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/626087/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2012-ema-decision-5-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-pitavastatin-associated-names-emea-000302-pip01-08-m03_en.pdf"},
    {"id":"9357","name":"P/0319/2015: EMA decision of 21 December 2015 on the granting of a product-specific waiver for recombinant human monoclonal IgG1 antibody directed against Programmed Death Ligand-1 (anti-PD-L1) (MSB0010718C) (EMEA-001849...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/791990/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0319-2015-ema-decision-21-december-2015-granting-product-specific-waiver-recombinant-human-monoclonal-igg1-antibody-directed-against-programmed-death-ligand-1-anti-pd-l1-msb0010718c-emea-001849_en.pdf"},
    {"id":"9371","name":"P/0124/2015: EMA decision of 5 June 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for misoprostol (EMEA-001601-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T02:00:00Z","last_updated_date":"2015-07-03T02:00:00Z","reference_number":"EMA/300766/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2015-ema-decision-5-june-2015-agreement-paediatric-investigation-plan-granting-waiver-misoprostol-emea-001601-pip01-13_en.pdf"},
    {"id":"9373","name":"P/159/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for telmisartan / hydrochlorothiazide (MicardisPlus)\n\n(EMEA-000885-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/477373/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-159-2010-ema-decision-27-august-2010-agreement-paediatric-investigation-plan-granting-product-specific-waiver-telmisartan-hydrochlorothiazide-micardisplus-emea-000885-pip01-10_en.pdf"},
    {"id":"9375","name":"P/0212/2013: EMA decision of 3 September 2013 on the granting of a product-specific waiver for risedronate sodium / colecalciferol (EMEA-001421-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/483102/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2013-ema-decision-3-september-2013-granting-product-specific-waiver-risedronate-sodium-colecalciferol-emea-001421-pip01-12_en.pdf"},
    {"id":"9418","name":"P/255/2011: EMA decision of 26 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for 2'-O-methyl-uridylyl-(3'→5' O,O-phosphorothioyl)-2'-O-methyl-cytidylyl-..(EMEA-000746-PIP01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T17:00:00Z","last_updated_date":"2011-11-30T17:00:00Z","reference_number":"EMA/764016/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-255-2011-ema-decision-26-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-2-o-methyl-uridylyl-3a5-oo-phosphorothioyl-2-o-methyl-cytidylyl-emea-000746-pip01_en.pdf"},
    {"id":"9450","name":"P/56/2011: EMA decision of 4 March 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bimatoprost (LUMIGAN 0.1 mg/ml eye drops, solution, LUMIGA...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/78091/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-56-2011-ema-decision-4-march-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bimatoprost-lumigan-01-mg-ml-eye-drops-solution-lumiga_en.pdf"},
    {"id":"9452","name":"P/0042/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for darbepoetin alfa (Aranesp), (EMEA-000329-PIP02-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/52905/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-darbepoetin-alfa-aranesp-emea-000329-pip02-09-m03_en.pdf"},
    {"id":"9468","name":"P/232/2010:  EMA decision of 23 November 2010 on the refusal of a product specific waiver for 4-hydroxy-n-(2-hydroxyethyl)-butyramide (EMEA-\n\n000764-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/663284/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-232-2010-ema-decision-23-november-2010-refusal-product-specific-waiver-4-hydroxy-n-2-hydroxyethyl-butyramide-emea-000764-pip01-09_en.pdf"},
    {"id":"9471","name":"P/0225/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for allantoin (EMEA-\n\n001590-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/460043/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-allantoin-emea-001590-pip01-13-m04_en.pdf"},
    {"id":"9491","name":"P/0034/2015: EMA decision of 6 March 2015on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec / insulin aspart (Ryzodeg), (EMEA-000479-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/86543/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2015-ema-decision-6-march-2015on-acceptance-modification-agreed-paediatric-investigation-plan-insulin-degludec-insulin-aspart-ryzodeg-emea-000479-pip01-08-m03_en.pdf"},
    {"id":"9499","name":"P/0276/2012: EMA decision of of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for simeprevir (EMEA-000625-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/10917/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0276-2012-ema-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-simeprevir-emea-000625-pip01-09-m02_en.pdf"},
    {"id":"9501","name":"P/0285/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for febuxostat (Adenuric), (EMEA-001417-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/690898/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0285-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-febuxostat-adenuric-emea-001417-pip01-12-m01_en.pdf"},
    {"id":"9512","name":"P/0015/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for siponimod (hemifumarate) (EMEA-000716-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-03-25T01:00:00Z","reference_number":"EMA/784023/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-siponimod-hemifumarate-emea-000716-pip01-09-m01_en.pdf"},
    {"id":"9541","name":"P/67/2011: EMA decision of 11 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for antigen of prepandemic strain A/Vietnam/1203/2004 propagated in vero cells (EMEA-000156-PIP01-07...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/412014/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-67-2011-ema-decision-11-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-antigen-prepandemic-strain-vietnam-1203-2004-propagated-vero-cells-emea-000156-pip01-07_en.pdf"},
    {"id":"9574","name":"P/0303/2016: EMA decision of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for influenza virus surface antigens (haemagglutinin and ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T01:00:00Z","last_updated_date":"2017-01-10T01:00:00Z","reference_number":"EMA/501874/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0303-2016-ema-decision-4-november-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-surface-antigens-haemagglutinin_en.pdf"},
    {"id":"9580","name":"P/0247/2017: EMA decision of 4 September 2017 on the granting of a product-specific waiver for litoxetine (benzoate) (EMEA-002151-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/497295/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2017-ema-decision-4-september-2017-granting-product-specific-waiver-litoxetine-benzoate-emea-002151-pip01-17_en.pdf"},
    {"id":"9584","name":"P/0154/2013: EMA decision of 5 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for selexipag (EMEA-000997-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/392509/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2013-ema-decision-5-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-selexipag-emea-000997-pip01-10-m01_en.pdf"},
    {"id":"9593","name":"P/0183/2012: EMA decision of 21 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for naloxegol (EMEA-001146-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T02:00:00Z","last_updated_date":"2012-09-18T02:00:00Z","reference_number":"EMA/472485/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0183-2012-ema-decision-21-august-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-naloxegol-emea-001146-pip01-11_en.pdf"},
    {"id":"9612","name":"P/31/2008: European medicines agency decision of 19 June 2008 on the application for agreement of a Paediatric Investigation Plan for dalbavancin, EMEA- 000016-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/306721/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-31-2008-european-medicines-agency-decision-19-june-2008-application-agreement-paediatric-investigation-plan-dalbavancin-emea-000016-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"9622","name":"P/0253/2016: EMA decision of 9 September 2016 on the refusal of a paediatric investigation plan and on the refusal of a deferral for angiotensin II\n\n(LJPC-501) (EMEA-001912-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/557943/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0253-2016-ema-decision-9-september-2016-refusal-paediatric-investigation-plan-refusal-deferral-angiotensin-ii-ljpc-501-emea-001912-pip01-15_en.pdf"},
    {"id":"9634","name":"P/0018/2017: EMA decision of 30 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for idelalisib (Zydelig),\n\n(EMEA-001350-PIP02-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/2921/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2017-ema-decision-30-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-idelalisib-zydelig-emea-001350-pip02-13-m03_en.pdf"},
    {"id":"9645","name":"P/0091/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for regorafenib\n\n(Stivarga), (EMEA-001178-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/181812/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-regorafenib-stivarga-emea-001178-pip01-11-m03_en.pdf"},
    {"id":"9656","name":"P/0253/2014: EMA decision of 29 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for expanded human allogeneic mesenchymal adult stem ce...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/528122/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0253-2014-ema-decision-29-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-expanded-human-allogeneic-mesenchymal-adult-stem-ce_en.pdf"},
    {"id":"9680","name":"P/0105/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bedaquiline (fumarate), (EMEA-000912-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/183759/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-bedaquiline-fumarate-emea-000912-pip01-10-m01_en.pdf"},
    {"id":"9706","name":"P/0002/2017: EMA decision of 12 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for belatacept (Nulojix),\n\n(EMEA-000157-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/5126/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2017-ema-decision-12-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-belatacept-nulojix-emea-000157-pip01-07-m03_en.pdf"},
    {"id":"9716","name":"P/198/2011: EMA decision of 30 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ulipristal acetate\n\n(EllaOne), (EMEA-000305-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/642354/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-198-2011-ema-decision-30-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-ulipristal-acetate-ellaone-emea-000305-pip01-08-m02_en.pdf"},
    {"id":"9735","name":"P/0148/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for etrolizumab (EMEA-001434-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/398302/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-etrolizumab-emea-001434-pip01-13-m01_en.pdf"},
    {"id":"9739","name":"P/91/2010: European Medicines Agency decision of 1 June 2010 on the  granting of a product specific waiver for fluocinolone acetonide (EMEA-000801-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the European...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-26T02:00:00Z","last_updated_date":"2010-07-26T02:00:00Z","reference_number":"EMA//337503/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-91-2010-european-medicines-agency-decision-1-june-2010-granting-product-specific-waiver-fluocinolone-acetonide-emea-000801-pip01-09-accordance-regulation-ec-no-1901-2006-european_en.pdf"},
    {"id":"9747","name":"P/0117/2012: EMA decision of 2 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for melatonin (Circadin), (EMEA-000440-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-08T16:45:00Z","last_updated_date":"2012-08-08T16:45:00Z","reference_number":"EMA/405270/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0117-2012-ema-decision-2-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-melatonin-circadin-emea-000440-pip02-11_en.pdf"},
    {"id":"9749","name":"P/0120/2013: EMA decision of 3 May 2013 on the granting of a product-specific waiver for Clostridium botulinum toxin type A, purified neurotoxin (EMEA-001396-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/202092/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2013-ema-decision-3-may-2013-granting-product-specific-waiver-clostridium-botulinum-toxin-type-purified-neurotoxin-emea-001396-pip01-12_en.pdf"},
    {"id":"9754","name":"P/0095/2018: EMA decision of 16 March 2018 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for non-pathogenic bacterial lysate of Escherichia coli and E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/102420/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0095-2018-ema-decision-16-march-2018-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-non-pathogenic-bacterial-lysate-escherichia-coli-e_en.pdf"},
    {"id":"9772","name":"P/0210/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sotagliflozin (EMEA-\n\n001517-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/430899/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-sotagliflozin-emea-001517-pip01-13-m01_en.pdf"},
    {"id":"9778","name":"P/0171/2014: EMA decision of 9 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant dimer of 6 kD early secretory antigenic target / recombinant 10 kD culture filtrate ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/349668/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2014-ema-decision-9-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-dimer-6-kd-early-secretory-antigenic-target-recombinant-10-kd-culture-filtrate_en.pdf"},
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    {"id":"9884","name":"P/0153/2017: EMA decision of 2 June 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for lacosamide\n\n(Vimpat), (EMEA-000402-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/341255/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2017-ema-decision-2-june-2017-agreement-paediatric-investigation-plan-granting-deferral-lacosamide-vimpat-emea-000402-pip03-17_en.pdf"},
    {"id":"9892","name":"P/313/2011: EMA decision of 22 December 2011 on the granting of a product specific waiver for anti-sclerostin human monoclonal antibody (AMG785)\n\n(EMEA-001075-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/983445/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-313-2011-ema-decision-22-december-2011-granting-product-specific-waiver-anti-sclerostin-human-monoclonal-antibody-amg785-emea-001075-pip01-10_en.pdf"},
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    {"id":"9936","name":"P/0075/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anifrolumab (EMEA-001435-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/91887/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anifrolumab-emea-001435-pip02-16_en.pdf"},
    {"id":"9938","name":"P/0182/2012: EMA decision of 21 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pegylated human interferon beta-1a (EMEA-001129-PIP01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T02:00:00Z","last_updated_date":"2012-09-18T02:00:00Z","reference_number":"EMA/532704/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2012-ema-decision-21-august-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pegylated-human-interferon-beta-1a-emea-001129-pip01_en.pdf"},
    {"id":"9958","name":"P/0168/2012: EMA decision of 26 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for MAGE-A3 recombinant protein (EMEA-001099-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T16:00:00Z","last_updated_date":"2012-08-23T16:00:00Z","reference_number":"EMA/481527/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2012-ema-decision-26-july-2012-agreement-paediatric-investigation-plan-granting-deferral-mage-a3-recombinant-protein-emea-001099-pip02-11_en.pdf"},
    {"id":"9972","name":"P/0116/2014: EMA decision of 6 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for poly(oxy-1,2-ethanediyl),alpha-hydro-omega-methoxy-133 ester with granulocyte colony-stimulating ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-12T16:00:00Z","last_updated_date":"2014-06-12T16:00:00Z","reference_number":"EMA/195554/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0116-2014-ema-decision-6-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-polyoxy-12-ethanediylalpha-hydro-omega-methoxy-133-ester-granulocyte-colony-stimulating_en.pdf"},
    {"id":"10003","name":"P/193/2011: EMA decision of 3 August 2011 on the granting of a product specific waiver for florbetaben (EMEA-001090-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/500224/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-193-2011-ema-decision-3-august-2011-granting-product-specific-waiver-florbetaben-emea-001090-pip01-11_en.pdf"},
    {"id":"10007","name":"P/0052/2018: EMA decision of 22 February 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for brivaracetam (Briviact), (EMEA-000332-PIP02-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/102423/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0052-2018-ema-decision-22-february-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-brivaracetam-briviact-emea-000332-pip02-17_en.pdf"},
    {"id":"10022","name":"P/0155/2013: EMA decision of 5 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for evacetrapib (EMEA-001180-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-09T16:30:00Z","last_updated_date":"2013-08-09T16:30:00Z","reference_number":"EMA/332288/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2013-ema-decision-5-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-evacetrapib-emea-001180-pip01-11_en.pdf"},
    {"id":"10028","name":"P/0036/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (EMEA-000576-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/43442/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-emea-000576-pip02-11-m02_en.pdf"},
    {"id":"10046","name":"P/90/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant\n\nhuman N-acetylgalactosamine-6-sulfatase (EMEA-000973-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/247811/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-90-2011-ema-decision-8-april-2011-agreement-paediatric-investigation-plan-granting-deferral-recombinant-human-n-acetylgalactosamine-6-sulfatase-emea-000973-pip01-10_en.pdf"},
    {"id":"10069","name":"P/0269/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/690906/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip03-15-m01_en.pdf"},
    {"id":"10070","name":"P/117/2009: European Medicines Agency decision of 16 June 2009 on the granting of a product specific waiver for Recombinant human anti-Rhesus D monoclonal antibody (LFB-R593) (EMEA-000512-PIP01-08) in accordance with Reg...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351778/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-117-2009-european-medicines-agency-decision-16-june-2009-granting-product-specific-waiver-recombinant-human-anti-rhesus-d-monoclonal-antibody-lfb-r593-emea-000512-pip01-08-accordance-reg_en.pdf"},
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    {"id":"10105","name":"P/0179/2016: EMA decision of of 8 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for levamisole\n\n(hydrochloride) (EMEA-001885-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:21:00Z","last_updated_date":"2016-09-22T16:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2016-ema-decision-8-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-levamisole-hydrochloride-emea-001885-pip01-15-m01_en.pdf"},
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    {"id":"10113","name":"P/0037/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for hydrochlorothiazide / amlodipine (besylate) / candesartan (cilexetil) (EMEA-002024-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/36030/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2017-european-medicines-agency-decision-31-january-2017-granting-product-specific-waiver-hydrochlorothiazide-amlodipine-besylate-candesartan-cilexetil-emea-002024-pip01-16_en.pdf"},
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    {"id":"10176","name":"P/0091/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for T-cell bispecific antibody targeting carcinoembryonic\n\nantigen expressed on tumor cells and CD3 epsilon chain present on T-cell...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/91876/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2018-ema-decision-16-march-2018-granting-product-specific-waiver-t-cell-bispecific-antibody-targeting-carcinoembryonic-antigen-expressed-tumor-cells-cd3-epsilon-chain-present-t-cell_en.pdf"},
    {"id":"10184","name":"P/233/2011: EMA decision of 26 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aciclovir (EMEA-001066-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/764286/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-233-2011-ema-decision-26-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aciclovir-emea-001066-pip02-11_en.pdf"},
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    {"id":"10224","name":"P/0221/2017: EMA decision of 11 August 2017 on the granting of a product specific waiver for 5, 7-dihydroxy-2-[3-hydroxy-4-methoxy-2-(2-methyl-\n\n2-propenyl) phenyl]-6, 8-bis (2-methyl-2-propenyl)-4H-chromen-4-one (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/460050/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2017-ema-decision-11-august-2017-granting-product-specific-waiver-5-7-dihydroxy-2-3-hydroxy-4-methoxy-2-2-methyl-2-propenyl-phenyl-6-8-bis-2-methyl-2-propenyl-4h-chromen-4-one-emea-0_en.pdf"},
    {"id":"10234","name":"P/0233/2015: EMA decision of 27 October 2015 on the granting of a product-specific waiver for nintedanib (Ofev) (EMEA-001006-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/619831/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2015-ema-decision-27-october-2015-granting-product-specific-waiver-nintedanib-ofev-emea-001006-pip02-15_en.pdf"},
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    {"id":"10279","name":"P/0021/2017: EMA decision of 3 February 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA-\n\n001501-PIP02-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-18T02:00:00Z","last_updated_date":"2017-04-18T02:00:00Z","reference_number":"EMA/38339/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2017-ema-decision-3-february-2017-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-emea-001501-pip02-13-m02_en.pdf"},
    {"id":"10283","name":"P/0298/2014: EMA decision of 24 November 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for cannabidiol / delta-9-tetrahydrocannabinol (Sativex), (EMEA-000181-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/641622/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2014-ema-decision-24-november-2014-agreement-paediatric-investigation-plan-granting-deferral-cannabidiol-delta-9-tetrahydrocannabinol-sativex-emea-000181-pip02-13_en.pdf"},
    {"id":"10313","name":"P/0076/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fluticasone furoate / umeclidinium bromide / vilanterol...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/75596/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fluticasone-furoate-umeclidinium-bromide-vilanterol_en.pdf"},
    {"id":"10332","name":"P/33/2010: European Medicines Agency decision of of 17 March 2010 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the refusal of a waiver for Sildenafil citrate (Revatio) (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-04-20T01:09:21Z","last_updated_date":"2010-04-20T01:09:21Z","reference_number":"EMA/159661/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-33-2010-european-medicines-agency-decision-17-march-2010-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-sildenafil-citrate-revatio-eme_en.pdf"},
    {"id":"10339","name":"P/0276/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for nitisinone (Orfadin), (EMEA-000784-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/592153/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0276-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-nitisinone-orfadin-emea-000784-pip02-11-m01_en.pdf"},
    {"id":"10375","name":"P/0293/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for potassium\n\n(chloride) / magnesium (sulphate heptahydrate) / procaine (hydrochloride) / xylit...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-19T11:00:00Z","last_updated_date":"2017-01-19T11:00:00Z","reference_number":"EMA/640003/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0293-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-potassium-chloride-magnesium-sulphate-heptahydrate-procaine-hydrochloride-xylit_en.pdf"},
    {"id":"10391","name":"P/0364/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for palovarotene\n\n(EMEA-001662-PIP01-14-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T13:05:00Z","last_updated_date":"2018-03-02T13:05:00Z","reference_number":"EMA/724437/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0364-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-palovarotene-emea-001662-pip01-14-m01_en.pdf"},
    {"id":"10432","name":"P/0298/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for travoprost (Travatan)\n\n(EMEA-001271-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/647635/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-travoprost-travatan-emea-001271-pip01-12-m01_en.pdf"},
    {"id":"10441","name":"P/107/2010: European Medicines Agency decision of 28 June 2010\n\non the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate mesilate (Pradaxa)( EMEA-000081-PIP01-07-M02) in acc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/398370/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-107-2010-european-medicines-agency-decision-28-june-2010-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-mesilate-pradaxa-emea-000081-pip01-07-m02-acc_en.pdf"},
    {"id":"10446","name":"P/0067/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins (Xeomin, Bocoutur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/147276/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0067-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-clostridium-botulinum-neurotoxin-type-150-kd-free-complexing-proteins-xeomin-bocoutur_en.pdf"},
    {"id":"10449","name":"P/102/2011: EMA decision of 3 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza)\n\n(EMEA-000128-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/247793/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-102-2011-ema-decision-3-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m03_en.pdf"},
    {"id":"10454","name":"P/0095/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for atomoxetine (hydrochloride) (Strattera), (EMEA-001167-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/206942/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0095-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-atomoxetine-hydrochloride-strattera-emea-001167-pip02-11-m01_en.pdf"},
    {"id":"10476","name":"P/0217/2016: EMA decision of 12 August 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for semaglutide (EMEA-001441-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/441093/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2016-ema-decision-12-august-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-semaglutide-emea-001441-pip02-15_en.pdf"},
    {"id":"10505","name":"P/26/2009: European Medicines Agency decision of 23 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for methoxy polyethylene glycol - epoetin beta, MIRCERA (EMEA-000172-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/99507/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-26-2009-european-medicines-agency-decision-23-february-2009-agreement-paediatric-investigation-plan-granting-waiver-methoxy-polyethylene-glycol-epoetin-beta-mircera-emea-000172-p_en.pdf"},
    {"id":"10519","name":"P/170/2010: European Medicines Agency decision of 3 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bosutinib, (EMEA-000727-PIP01-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/478080/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-170-2010-european-medicines-agency-decision-3-september-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bosutinib-emea-000727-pip01-0_en.pdf"},
    {"id":"10566","name":"P/80/2011: EMA decision of 6 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine hydrochloride (Corlentor) (EMEA-000627-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/213008/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-80-2011-ema-decision-6-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-corlentor-emea-000627-pip01-09-m01_en.pdf"},
    {"id":"10593","name":"P/0305/2014: EMA decision of 24 November 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for naloxone (hydrochloride) (EMEA-001567-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/643802/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0305-2014-ema-decision-24-november-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-naloxone-hydrochloride-emea-001567-pip01-13_en.pdf"},
    {"id":"10629","name":"P/0219/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for naloxone (EMEA-001567-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/578879/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-naloxone-emea-001567-pip01-13-m01_en.pdf"},
    {"id":"10667","name":"P/0313/2017: EMA decision of 30 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for febuxostat\n\n(Adenuric), (EMEA-001417-PIP01-12-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-02-15T01:00:00Z","last_updated_date":"2018-02-15T01:00:00Z","reference_number":"EMA/654877/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0313-2017-ema-decision-30-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-febuxostat-adenuric-emea-001417-pip01-12-m03_en.pdf"},
    {"id":"10671","name":"P/0282/2013: EMA decision of 8 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-12-06T01:00:00Z","last_updated_date":"2013-12-06T01:00:00Z","reference_number":"EMA/670636/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0282-2013-ema-decision-8-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"10676","name":"P/290/2010: EMA decision of of 22 December 2010 on the acceptance of a modification of an agreed paediatric investigation plan for entecavir (Baraclude), (EMEA-000339-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/789203/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-290-2010-ema-decision-22-december-2010-acceptance-modification-agreed-paediatric-investigation-plan-entecavir-baraclude-emea-000339-pip02-09-m01_en.pdf"},
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    {"id":"10705","name":"P/0104/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate) / mometasone (furoate) (EMEA-001217-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/199532/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0104-2016-ema-decision-15-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-indacaterol-acetate-mometasone-furoate-emea-001217-pip01-11-m02_en.pdf"},
    {"id":"10706","name":"P/0197/2012: EMA decision of 24 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (000558-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/502094/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2012-ema-decision-24-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-000558-pip01-09-m01_en.pdf"},
    {"id":"10708","name":"P/0391/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide\n\nadsorbed, depigmented glutaraldehyde polymerised, allergic extract of ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/792972/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0391-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergic-extract_en.pdf"},
    {"id":"10717","name":"P/0102/2015: European medicines agency decision of 11 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine Bilaxten and associated names (EMEA-000347-PIP01-08-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/281890/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2015-european-medicines-agency-decision-11-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-associated-names-emea-000347-pip01-08-m05_en.pdf"},
    {"id":"10719","name":"P/0019/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for albiglutide (EMEA-001175-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/738893/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-albiglutide-emea-001175-pip01-11-m01_en.pdf"},
    {"id":"10724","name":"P/39/2011: EMA decision of 4 February 2011 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (EMEA-000237-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T01:00:00Z","last_updated_date":"2011-03-09T00:00:00Z","reference_number":"EMA/67881/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-39-2011-ema-decision-4-february-2011-acceptance-modification-agreed-paediatric-investigation-plan-azilsartan-medoxomil-emea-000237-pip01-08-m03_en.pdf"},
    {"id":"10735","name":"P/0031/2016: EMA decision of 29 January 2016 on the granting of a product specific waiver for revusiran (EMEA-001836-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/13230/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0031-2016-ema-decision-29-january-2016-granting-product-specific-waiver-revusiran-emea-001836-pip01-15_en.pdf"},
    {"id":"10736","name":"P/28/2008: European medicines agency decision of 23 May 2008 on the application for agreement of a Paediatric Investigation Plan for adenovirus-mediated Herpes simplex virus-thymidine kinase gene (EMEA-000140-PIP01-07) i...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-17T02:00:00Z","last_updated_date":"2008-07-17T02:00:00Z","reference_number":"EMEA/259189/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-28-2008-european-medicines-agency-decision-23-may-2008-application-agreement-paediatric-investigation-plan-adenovirus-mediated-herpes-simplex-virus-thymidine-kinase-gene-emea-000140-pip01-07-i_en.pdf"},
    {"id":"10763","name":"P/177/2010: European Medicines Agency decision of 21 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for artemether / lumefantrine (Ria...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/572669/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-177-2010-european-medicines-agency-decision-21-september-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-artemether-lumefantrine-ria_en.pdf"},
    {"id":"10767","name":"P/107/2012: EMA decision of 8 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for modified grass pollen extract (EMEA-000284-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/332274/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-107-2012-ema-decision-8-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-modified-grass-pollen-extract-emea-000284-pip01-08-m03_en.pdf"},
    {"id":"10771","name":"P/0179/2015: EMA decision of 7 August 2015 on the granting of a product-specific waiver for (S)-1-{5-Phenyl-4-[(pyridin-2-ylmethyl)-amino]-thieno[2,3-d]pyrimidin-2-yl}-piperidine-3-carboxylic acid (2-hydroxy-ethyl)-amide...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-22T02:00:00Z","last_updated_date":"2015-09-22T02:00:00Z","reference_number":"EMA/434216/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2015-ema-decision-7-august-2015-granting-product-specific-waiver-s-1-5-phenyl-4-pyridin-2-ylmethyl-amino-thieno23-dpyrimidin-2-yl-piperidine-3-carboxylic-acid-2-hydroxy-ethyl-amide_en.pdf"},
    {"id":"10788","name":"P/0162/2017: EMA decision of 30 June 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for empagliflozin (Jardiance), (EMEA-000828-PIP04-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/398408/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2017-ema-decision-30-june-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-empagliflozin-jardiance-emea-000828-pip04-16_en.pdf"},
    {"id":"10795","name":"P/0108/2015: EMA decision of 1 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sunitinib (Sutent), (EMEA-000342-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/321148/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0108-2015-ema-decision-1-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-sunitinib-sutent-emea-000342-pip01-08-m04_en.pdf"},
    {"id":"10804","name":"P/216/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 12 Grass Pollen Extract and Cult...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/615516/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-216-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-12-grass-pollen-extract-cult_en.pdf"},
    {"id":"10821","name":"P/0139/2014: EMA decision of 11 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for PEGylated recombinant factor VIII (EMEA-001296-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-28T02:00:00Z","last_updated_date":"2014-07-28T02:00:00Z","reference_number":"EMA/268980/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2014-ema-decision-11-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-pegylated-recombinant-factor-viii-emea-001296-pip01-12-m01_en.pdf"},
    {"id":"10838","name":"P/0230/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for fingolimod\n\n(hydrochloride) (Gilenya), (EMEA-000087-PIP01-07-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/576559/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2016-ema-decision-9-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-fingolimod-hydrochloride-gilenya-emea-000087-pip01-07-m04_en.pdf"},
    {"id":"10840","name":"P/0273/2013: EMA decision of 30 October 2013 on the granting of a product specific waiver for ezetimibe / atorvastatin (EMEA-001477-PIP01-13)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/587980/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0273-2013-ema-decision-30-october-2013-granting-product-specific-waiver-ezetimibe-atorvastatin-emea-001477-pip01-13_en.pdf"},
    {"id":"10867","name":"P/0398/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica) (EMEA-001397-PIP03-14-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T11:48:00Z","last_updated_date":"2018-03-02T11:48:00Z","reference_number":"EMA/797361/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0398-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-ibrutinib-imbruvica-emea-001397-pip03-14-m03_en.pdf"},
    {"id":"10873","name":"P/0354/2016: EMA decision of 21 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sacubitril / valsartan (Entresto), (EMEA-000316-PIP02-11-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T09:55:00Z","last_updated_date":"2017-01-30T09:55:00Z","reference_number":"EMA/788570/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0354-2016-ema-decision-21-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-sacubitril-valsartan-entresto-emea-000316-pip02-11-m03_en.pdf"},
    {"id":"10875","name":"P/0211/2014: EMA decision of of 22 August 2014 on the granting of a product specific waiver for rosuvastatin / valsartan (EMEA-001632-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/467371/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2014-ema-decision-22-august-2014-granting-product-specific-waiver-rosuvastatin-valsartan-emea-001632-pip01-14_en.pdf"},
    {"id":"10877","name":"P/187/2011: EMA decision of 29 July 2011 on the granting of a product specific waiver for perindopril (erbumine) / amlodipine (besylate) (EMEA-\n\n001141-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/500622/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-187-2011-ema-decision-29-july-2011-granting-product-specific-waiver-perindopril-erbumine-amlodipine-besylate-emea-001141-pip01-11_en.pdf"},
    {"id":"10880","name":"P/130/2009: European Medicines Agency decision of 14 July 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for drospirenone / ethinylestradiol, betadex clathrate / L-5-methyltetrahyd...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/420939/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-130-2009-european-medicines-agency-decision-14-july-2009-refusal-paediatric-investigation-plan-granting-waiver-drospirenone-ethinylestradiol-betadex-clathrate-l-5-methyltetrahyd_en.pdf"},
    {"id":"10913","name":"P/314/2011: EMA decision of 22 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin succinate (Vesicare and associated names) (EMEA-000573-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/984967/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-314-2011-ema-decision-22-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip01-09-m01_en.pdf"},
    {"id":"10919","name":"P/0177/2012: EMA decision of 17 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone\n\ndipropionate / formoterol fumarate dihydrate (Foster and associated names, Kan...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/502097/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2012-ema-decision-17-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-beclometasone-dipropionate-formoterol-fumarate-dihydrate-foster-associated-names-kan_en.pdf"},
    {"id":"10921","name":"P/0203/2017: EMA decision of 9 August 2017 on the granting of a product specific waiver for diclofenac (sodium) (Pennsaid), (EMEA-002132-PIP01-\n\n17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/460841/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2017-ema-decision-9-august-2017-granting-product-specific-waiver-diclofenac-sodium-pennsaid-emea-002132-pip01-17_en.pdf"},
    {"id":"10930","name":"P/149/2010:  European Medicines Agency decision of 30 July 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chloroprocaine hydrochloride, (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/469130/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-149-2010-european-medicines-agency-decision-30-july-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chloroprocaine-hydrochloride-eme_en.pdf"},
    {"id":"10943","name":"P/0005/2017: European Medicines Agency decision of 16 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abatacept (Orencia), (EMEA-0001...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/13161/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2017-european-medicines-agency-decision-16-january-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-abatacept-orencia-emea-0001_en.pdf"},
    {"id":"10945","name":"P/0046/2016: EMA decision of 26 February 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eculizumab (Soliris) (EMEA-000876-PIP05-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/133082/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2016-ema-decision-26-february-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eculizumab-soliris-emea-000876-pip05-15_en.pdf"},
    {"id":"10953","name":"P/15/2011: EMA  decision of 21 January 2011 on the application for agreement of a Paediatric Investigation Plan for ezetimibe, EZETROL and associated names, EMEA-000007-PIP01-07-M01 in accordance with Regulation (EC) No ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-08T02:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/27910/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-15-2011-ema-decision-21-january-2011-application-agreement-paediatric-investigation-plan-ezetimibe-ezetrol-associated-names-emea-000007-pip01-07-m01-accordance-regulation-ec-no_en.pdf"},
    {"id":"11005","name":"P/0010/2013: EMA decision of 22 January 2013 on the granting of a product-specific waiver for amlodipine (besylate) / atorvastatin (calcium), (EMEA-001353-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T14:30:00Z","last_updated_date":"2013-04-03T14:30:00Z","reference_number":"EMA/779486/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2013-ema-decision-22-january-2013-granting-product-specific-waiver-amlodipine-besylate-atorvastatin-calcium-emea-001353-pip01-12_en.pdf"},
    {"id":"11036","name":"P/0058/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for canakinumab (EMEA-000060-PIP05-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/153862/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2015-ema-decision-1-april-2015-agreement-paediatric-investigation-plan-granting-waiver-canakinumab-emea-000060-pip05-14_en.pdf"},
    {"id":"11049","name":"P/0058/2012: EMA decision of 26 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine\n\n(acetate) (Zebinix, Exalief), (EMEA-000696-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T17:42:00Z","last_updated_date":"2012-04-20T17:42:00Z","reference_number":"EMA/196227/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2012-ema-decision-26-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-eslicarbazepine-acetate-zebinix-exalief-emea-000696-pip02-10-m01_en.pdf"},
    {"id":"11061","name":"P/0237/2012: EMA decision of 22 October 2012 on the agreement of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for human heterologous liver cells (EMEA-000067-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/587322/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0237-2012-ema-decision-22-october-2012-agreement-paediatric-investigation-plan-refusal-deferral-granting-waiver-human-heterologous-liver-cells-emea-000067-pip02-11_en.pdf"},
    {"id":"11083","name":"P/0231/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dihydroartemisinin /\n\npiperaquine phosphate anhydride (Eurartesim), (EMEA-000153-PIP01-07-M...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/557959/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2016-ema-decision-9-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-dihydroartemisinin-piperaquine-phosphate-anhydride-eurartesim-emea-000153-pip01-07-m_en.pdf"},
    {"id":"11092","name":"P/0101/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for evolocumab\n\n(Repatha), (EMEA-001268-PIP01-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/202483/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-evolocumab-repatha-emea-001268-pip01-12-m04_en.pdf"},
    {"id":"11096","name":"P/0335/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant single chain coagulation factor VIII (EMEA-001215-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T01:00:00Z","last_updated_date":"2015-02-23T01:00:00Z","reference_number":"EMA/713540/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0335-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-single-chain-coagulation-factor-viii-emea-001215-pip01-11-m02_en.pdf"},
    {"id":"11112","name":"P/213/2010: European Medicines Agency decision of 29 October 2010 on the granting of a product specific waiver for fampridine (EMEA-000614-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T00:09:21Z","last_updated_date":"2010-11-25T00:09:21Z","reference_number":"EMA/655503/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-213-2010-european-medicines-agency-decision-29-october-2010-granting-product-specific-waiver-fampridine-emea-000614-pip01-10-m01_en.pdf"},
    {"id":"11136","name":"P/0226/2016: EMA decision of 12 August 2016 on the granting of a product specific waiver for ramipril / amlodipine / hydrochlorothiazide (EMEA-\n\n001942-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/472133/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2016-ema-decision-12-august-2016-granting-product-specific-waiver-ramipril-amlodipine-hydrochlorothiazide-emea-001942-pip01-16_en.pdf"},
    {"id":"11158","name":"P/0147/2012: EMA decision of 24 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract from the...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/471477/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2012-ema-decision-24-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract_en.pdf"},
    {"id":"11166","name":"P/0305/2015: EMA decision of 21 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for lorcaserin (EMEA-001098-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/759834/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0305-2015-ema-decision-21-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-lorcaserin-emea-001098-pip01-10-m01_en.pdf"},
    {"id":"11192","name":"P/12/2011:  EMA decision of 3 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pollen from alnus glutinosa (33%), betula verrucosa (33...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/753903/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-12-2011-ema-decision-3-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-alnus-glutinosa-33-betula-verrucosa-33_en.pdf"},
    {"id":"11203","name":"P/113/2011: EMA decision of 27 April 2011 on the granting of a product specific waiver for rivastigmine (Exelon and Prometax) (EMEA-001084-\n\nPIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/320397/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-113-2011-ema-decision-27-april-2011-granting-product-specific-waiver-rivastigmine-exelon-prometax-emea-001084-pip02-11_en.pdf"},
    {"id":"11206","name":"P/47/2009: European Medicines Agency decision of 24 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for cysteamine hydrochloride (EMEA-0003...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/158143/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-47-2009-european-medicines-agency-decision-24-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cysteamine-hydrochloride-emea-0003_en.pdf"},
    {"id":"11240","name":"P/0098/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for fidaxomicin (Dificlir)\n\n(EMEA-000636-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/199518/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0098-2016-ema-decision-15-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-fidaxomicin-dificlir-emea-000636-pip01-09-m04_en.pdf"},
    {"id":"11257","name":"P/0056/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapentad...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T02:00:00Z","last_updated_date":"2015-04-24T02:00:00Z","reference_number":"EMA/155881/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0056-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapentad_en.pdf"},
    {"id":"11286","name":"P/0252/2015: EMA decision of 30 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ibrutinib, (Imbruvica) (EMEA-001397-PIP03-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-18T01:00:00Z","last_updated_date":"2015-12-18T01:00:00Z","reference_number":"EMA/627047/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2015-ema-decision-30-october-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ibrutinib-imbruvica-emea-001397-pip03-14_en.pdf"},
    {"id":"11325","name":"P/14/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide, (Copalia HCT), (EMEA-000397-PIP01-08) in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/24151/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-14-2009-european-medicines-agency-decision-27-january-2009-granting-product-specific-waiver-amlodipine-besylate-valsartan-hydrochlorothiazide-copalia-hct-emea-000397-pip01-08-accordance-w_en.pdf"},
    {"id":"11338","name":"P/0001/2015: EMA decision of 7 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta) (EMEA-000498-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-17T01:00:00Z","last_updated_date":"2015-02-17T01:00:00Z","reference_number":"EMA/776083/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2015-ema-decision-7-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-trajenta-emea-000498-pip01-08-m04_en.pdf"},
    {"id":"11339","name":"P/0018/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sonidegib (Odomzo) (EMEA-000880-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/3207/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-sonidegib-odomzo-emea-000880-pip02-11-m03_en.pdf"},
    {"id":"11343","name":"P/0224/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for bivalent anti-human\n\nmyostatin adnectin recombinant human IgG1-Fc fusion protein (BMS-986089)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/460045/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-bivalent-anti-human-myostatin-adnectin-recombinant-human-igg1-fc-fusion-protein-bms-986089_en.pdf"},
    {"id":"11368","name":"P/0183/2013: EMA decision of 31 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ferric citrate (EMEA-001213-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/393022/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0183-2013-ema-decision-31-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ferric-citrate-emea-001213-pip02-12_en.pdf"},
    {"id":"11383","name":"P/0264/2014: EMA decision of 3 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for fidaxomicin (Dificlir), (EMEA-000636-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/591650/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0264-2014-ema-decision-3-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-fidaxomicin-dificlir-emea-000636-pip01-09-m03_en.pdf"},
    {"id":"11388","name":"P/44/2007: European medicines agency decision of 23 June 2008 on the application for agreement of a Paediatric Investigation Plan for Nicotinic acid and laropiprant (EMEA-000063-PIP01-07) in accordance with Regulation (E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/315476/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-44-2007-european-medicines-agency-decision-23-june-2008-application-agreement-paediatric-investigation-plan-nicotinic-acid-laropiprant-emea-000063-pip01-07-accordance-regulation-e_en.pdf"},
    {"id":"11414","name":"P/221/2011: EMA decision of 26 September 2011 on the granting of a product specific waiver for dapagliflozin / metformin hydrochloride (EMEA-001151-\n\nPIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/679347/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-221-2011-ema-decision-26-september-2011-granting-product-specific-waiver-dapagliflozin-metformin-hydrochloride-emea-001151-pip01-11_en.pdf"},
    {"id":"11415","name":"P/0365/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for galcanezumab (EMEA-001860-PIP04-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-07-20T13:52:00Z","reference_number":"EMA/788580/2016 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0365-2016-ema-decision-21-december-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-galcanezumab-emea-001860-pip04-16_en.pdf"},
    {"id":"11459","name":"P/0195/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (EMEA-001460-PIP01-13-M01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/532368/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-emea-001460-pip01-13-m01_en.pdf"},
    {"id":"11478","name":"P/258/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of Birch, Hazel and Alder allergen extracts (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/710506/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-258-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mixture-birch-hazel-alder-allergen-extracts_en.pdf"},
    {"id":"11480","name":"P/0080/2012: EMA decision of 27 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for boceprevir (Victrelis), (EMEA-000583-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/229260/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2012-ema-decision-27-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-boceprevir-victrelis-emea-000583-pip01-09-m04_en.pdf"},
    {"id":"11510","name":"P/110/2012: EMA decision of 18 June 2012 on the refusal of a paediatric investigation plan and on the granting of a waiver for bivalirudin\n\n(Angiox), (EMEA-001065-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-19T17:00:00Z","last_updated_date":"2012-07-19T17:00:00Z","reference_number":"EMA/332323/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-110-2012-ema-decision-18-june-2012-refusal-paediatric-investigation-plan-granting-waiver-bivalirudin-angiox-emea-001065-pip01-10_en.pdf"},
    {"id":"11520","name":"P/0113/2013: EMA decision of 30 April 2013 on the granting of a product-specific waiver for amlodipine (besilate) / losartan (potassium) (EMEA-001390-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203291/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2013-ema-decision-30-april-2013-granting-product-specific-waiver-amlodipine-besilate-losartan-potassium-emea-001390-pip01-12_en.pdf"},
    {"id":"11527","name":"P/0309/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tilmanocept (Lymphoseek), (EMEA-001255-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/773337/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0309-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-tilmanocept-lymphoseek-emea-001255-pip01-11-m01_en.pdf"},
    {"id":"11545","name":"P/160/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for house dust mites\n\nallergen extracts (EMEA-000319-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/398971/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-160-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-house-dust-mites-allergen-extracts-emea-000319-pip01-08-m02_en.pdf"},
    {"id":"11548","name":"P/0207/2013: EMA decision of 3 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion protein consisting of human coagulation factor VIII attached to the Fc d...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/476176/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2013-ema-decision-3-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-consisting-human-coagulation-factor-viii-attached-fc-d_en.pdf"},
    {"id":"11551","name":"P/0155/2017: EMA decision of 2 June 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for mexiletine\n\n(hydrochloride), (EMEA-002012-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/354124/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2017-ema-decision-2-june-2017-agreement-paediatric-investigation-plan-granting-deferral-mexiletine-hydrochloride-emea-002012-pip01-16_en.pdf"},
    {"id":"11563","name":"P/0057/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate) / mometasone (furoate) (EMEA-001217-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/75528/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-indacaterol-acetate-mometasone-furoate-emea-001217-pip01-11-m04_en.pdf"},
    {"id":"11573","name":"P/309/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of birch and hazel pollen (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/769333/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-309-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-birch-hazel-pollen_en.pdf"},
    {"id":"11633","name":"P/0004/2013: EMA decision of 21 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for propranolol hydrochloride (EMEA-000511-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/795938/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2013-ema-decision-21-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-propranolol-hydrochloride-emea-000511-pip01-08-m04_en.pdf"},
    {"id":"11679","name":"P/330/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Aqueous allergen extract of birch (EMEA-000959-PIP01-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMEA/778433/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-330-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aqueous-allergen-extract-birch-emea-000959-pip01_en.pdf"},
    {"id":"11699","name":"P/0135/2015: EMA decision of 15 June 2015 on the granting of a product-specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T02:00:00Z","last_updated_date":"2015-07-03T02:00:00Z","reference_number":"EMA/368601/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2015-ema-decision-15-june-2015-granting-product-specific-waiver-tocilizumab-roactemra-emea-000309-pip02-14_en.pdf"},
    {"id":"11731","name":"P/0294/2017: EMA decision of 4 October 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for influenza virus surface antigens (haemagglutinin) of ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/626320/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2017-ema-decision-4-october-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-surface-antigens-haemagglutinin_en.pdf"},
    {"id":"11746","name":"P/31/2009: European Medicines Agency decision of 23 February 2009 on the granting of a product specific waiver for aliskiren hemifumarate / hydrochlorothiazide (EMEA-000343-PIP01-08 ) in accordance with Regulation (EC) N...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/101813/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-31-2009-european-medicines-agency-decision-23-february-2009-granting-product-specific-waiver-aliskiren-hemifumarate-hydrochlorothiazide-emea-000343-pip01-08-accordance-regulation-ec-n_en.pdf"},
    {"id":"11755","name":"P/0115/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names) (EMEA-000573-PIP02-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/355269/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0115-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip02-13-m03_en.pdf"},
    {"id":"11771","name":"P/48/2011: EMA decision of 4 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion Influenza A/Indonesia/5/05/ (H5N1), (EMEA-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2011-04-05T12:56:34Z","reference_number":"EMA/78785/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-48-2011-ema-decision-4-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-purified-antigen-fractions-inactivated-split-virion-influenza-indonesia-5-05-h5n1-emea_en.pdf"},
    {"id":"11772","name":"P/0166/2013: EMA decision of 30 July on the acceptance of a modification of an agreed paediatric investigation plan for 2'-O-methyl-uridylyl-\n\n(3'→5' O,O-phosphorothioyl)-2'-O-methyl-cytidyly... (EMEA-000746-PIP01-09-M...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/378889/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2013-ema-decision-30-july-acceptance-modification-agreed-paediatric-investigation-plan-2-o-methyl-uridylyl-3a5-oo-phosphorothioyl-2-o-methyl-cytidyly-emea-000746-pip01-09-m_en.pdf"},
    {"id":"11773","name":"P/0276/2016: EMA decision of 10 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / vilanterol (Relvar Ellipta and associated names), (EMEA-000431-PIP01-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/632356/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0276-2016-ema-decision-10-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-vilanterol-relvar-ellipta-associated-names-emea-000431-pip01-0_en.pdf"},
    {"id":"11777","name":"P/0267/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for L-asparaginase\n\nencapsulated in erythrocytes (EMEA-000341-PIP02-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T17:00:00Z","last_updated_date":"2017-10-25T17:00:00Z","reference_number":"EMA/565799/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-l-asparaginase-encapsulated-erythrocytes-emea-000341-pip02-09-m04_en.pdf"},
    {"id":"11799","name":"P/0144/2016: EMA decision of 23 May 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for human recombinant IgG1 monoclonal antibody targeting fibroblast growth factor 23 (KRN23) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/269233/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0144-2016-ema-decision-23-may-2016-agreement-paediatric-investigation-plan-granting-deferral-human-recombinant-igg1-monoclonal-antibody-targeting-fibroblast-growth-factor-23-krn23_en.pdf"},
    {"id":"11813","name":"P/0184/2017: EMA decision of 30 June 2017 on the granting of a product-specific waiver for econazole (nitrate) / benzydamine (hydrochloride)\n\n(EMEA-002143-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/371181/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2017-ema-decision-30-june-2017-granting-product-specific-waiver-econazole-nitrate-benzydamine-hydrochloride-emea-002143-pip01-17_en.pdf"},
    {"id":"11838","name":"P/0227/2012: EMA decision of 3 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for glycopegylated recombinant coagulation factor VIII (EMEA-001174-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/616386/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2012-ema-decision-3-october-2012-agreement-paediatric-investigation-plan-granting-deferral-glycopegylated-recombinant-coagulation-factor-viii-emea-001174-pip02-12_en.pdf"},
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    {"id":"11879","name":"P/0310/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pixantrone\n\n(dimaleate) (Pixuvri), (EMEA-000713-PIP02-10-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-19T15:50:00Z","last_updated_date":"2017-01-19T15:50:00Z","reference_number":"EMA/719274/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-pixantrone-dimaleate-pixuvri-emea-000713-pip02-10-m04_en.pdf"},
    {"id":"11881","name":"P/0267/2013: EMA decision of30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ozenoxacin (EMEA-000981-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/588641/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2013-ema-decision-of30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-ozenoxacin-emea-000981-pip01-10-m03_en.pdf"},
    {"id":"11883","name":"P/0171/2016: EMA decision of 17 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for atrasentan\n\n(hydrochloride) (EMEA-001666-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/385694/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2016-ema-decision-17-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-atrasentan-hydrochloride-emea-001666-pip01-14-m01_en.pdf"},
    {"id":"11887","name":"P/0179/2014: EMA decision of 11 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human lysosomal acid lipase (EMEA-001331-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/391453/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2014-ema-decision-11-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-lysosomal-acid-lipase-emea-001331-pip01-12-m01_en.pdf"},
    {"id":"11894","name":"P/227/2011: EMA decision of 28 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for dihydroartemisinin /\n\npiperaquine phosphate anhydride (EMEA-000153-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/691622/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-227-2011-ema-decision-28-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-dihydroartemisinin-piperaquine-phosphate-anhydride-emea-000153-pip01-07-m01_en.pdf"},
    {"id":"11926","name":"P/79/2010: European Medicines Agency decision of 7 May 2010\n\non the agreement of a paediatric investigation plan and on the granting of a deferral for perampanel (EMEA-000467-PIP01-08) in accordance with Regulation (EC) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/261727/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-79-2010-european-medicines-agency-decision-7-may-2010-agreement-paediatric-investigation-plan-granting-deferral-perampanel-emea-000467-pip01-08-accordance-regulation-ec_en.pdf"},
    {"id":"11979","name":"P/0125/2014: EMA decision of 16 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for entecavir (monohydrate) (Baraclude), (EMEA-000339-PIP02-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-25T02:00:00Z","last_updated_date":"2014-06-25T02:00:00Z","reference_number":"EMA/280408/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2014-ema-decision-16-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-entecavir-monohydrate-baraclude-emea-000339-pip02-09-m03_en.pdf"},
    {"id":"12046","name":"P/0307/2017: EMA decision of 30 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for andexanet alfa\n\n(EMEA-001902-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/654890/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2017-ema-decision-30-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-andexanet-alfa-emea-001902-pip01-15-m01_en.pdf"},
    {"id":"12049","name":"P/38/2011: EMA decision on 17 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for N.meningitidis Outer Membrane Vesicles (OMV) from NZ 98/254 strain, N.meningitidis 287-953 pur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/42919/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-38-2011-ema-decision-17-january-2011-acceptance-modification-agreed-paediatric-investigation-plan-nmeningitidis-outer-membrane-vesicles-omv-nz-98-254-strain-nmeningitidis-287-953-pur_en.pdf"},
    {"id":"12064","name":"P/0347/2016: EMA decision of 5 December 2016 on the granting of a product specific waiver for synthetic double-stranded siRNA oligonucleotide\n\ndirected against p53 mRNA (QPI-1002) (EMEA-001993-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/760455/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0347-2016-ema-decision-5-december-2016-granting-product-specific-waiver-synthetic-double-stranded-sirna-oligonucleotide-directed-against-p53-mrna-qpi-1002-emea-001993-pip01-16_en.pdf"},
    {"id":"12066","name":"P/2/2008: European medicines agency decision of 1 February 2008 on the application for a product specific waiver for Indacaterol maleate EMEA-000043-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europea...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-02-01T00:00:00Z","last_updated_date":"2008-02-01T00:00:00Z","reference_number":"EMEA/43267/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-2-2008-european-medicines-agency-decision-1-february-2008-application-product-specific-waiver-indacaterol-maleate-emea-000043-pip01-07-accordance-regulation-ec-no-1901-2006-europea_en.pdf"},
    {"id":"12072","name":"P/62/2009: European Medicines Agency decision of 27 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for sitagliptin phosphate monohydrate (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/174958/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-62-2009-european-medicines-agency-decision-27-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sitagliptin-phosphate-monohydrate_en.pdf"},
    {"id":"12157","name":"P/0174/2013: EMA decision of 30 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for alpha\n\ntocotrienol quinone (EMEA-001238-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/393021/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2013-ema-decision-30-july-2013-agreement-paediatric-investigation-plan-granting-deferral-alpha-tocotrienol-quinone-emea-001238-pip01-12_en.pdf"},
    {"id":"12158","name":"P/0236/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo), (EMEA-000065-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/636818/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-telbivudine-sebivo-emea-000065-pip01-07-m03_en.pdf"},
    {"id":"12163","name":"P/0258/2012: EMA decision of 31 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for regorafenib (EMEA-001178-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/689054/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0258-2012-ema-decision-31-october-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-regorafenib-emea-001178-pip01-11_en.pdf"},
    {"id":"12170","name":"P/0108/2014: EMA decision of 5 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for naloxegol (EMEA-001146-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-12T16:00:00Z","last_updated_date":"2014-06-12T16:00:00Z","reference_number":"EMA/235395/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0108-2014-ema-decision-5-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-naloxegol-emea-001146-pip01-11-m01_en.pdf"},
    {"id":"12183","name":"P/0214/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for lurasidone (hydrochloride) (Latuda) (EMEA-001230-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/520138/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-lurasidone-hydrochloride-latuda-emea-001230-pip01-11-m02_en.pdf"},
    {"id":"12216","name":"P/0055/2014: European Medicines Agency decision of 8 March 2014 on the granting of a product specific waiver for telmisartan / amlodipine (besylate) (EMEA-001552-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/57059/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2014-european-medicines-agency-decision-8-march-2014-granting-product-specific-waiver-telmisartan-amlodipine-besylate-emea-001552-pip01-13_en.pdf"},
    {"id":"12219","name":"P/0298/2016: EMA decision of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-06T01:00:00Z","last_updated_date":"2017-01-06T01:00:00Z","reference_number":"EMA/667315/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2016-ema-decision-4-november-2016-agreement-paediatric-investigation-plan-granting-deferral-humanised-chimeric-antibody-humanised-h-chain-chimeric-mouse-v-domain_en.pdf"},
    {"id":"12231","name":"P/0100/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ixekizumab (EMEA-001050-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/188347/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0100-2016-ema-decision-15-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-ixekizumab-emea-001050-pip01-10-m01_en.pdf"},
    {"id":"12249","name":"P/0308/2016: EMA decision of 4 November 2016 on the granting of a product-specific waiver for candesartan / amlodipine (EMEA-002014-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T01:00:00Z","last_updated_date":"2017-01-10T01:00:00Z","reference_number":"EMA/639657/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2016-ema-decision-4-november-2016-granting-product-specific-waiver-candesartan-amlodipine-emea-002014-pip01-16_en.pdf"},
    {"id":"12265","name":"P/0145/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP03-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/308179/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip03-11-m04_en.pdf"},
    {"id":"12291","name":"P/0125/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Xgeva), (EMEA-000145-PIP01-07-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T02:00:00Z","last_updated_date":"2016-07-27T02:00:00Z","reference_number":"EMA/269205/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-xgeva-emea-000145-pip01-07-m08_en.pdf"},
    {"id":"12366","name":"P/0300/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla) (EMEA-000715-PIP03-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/792939/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip03-11-m03_en.pdf"},
    {"id":"12367","name":"P/0038/2018: EMA decision of 30 January 2018 on the granting of a product specific waiver for recombinant human epidermal growth factor (EMEA-\n\n002258-PIP01-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/848796/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0038-2018-ema-decision-30-january-2018-granting-product-specific-waiver-recombinant-human-epidermal-growth-factor-emea-002258-pip01-17_en.pdf"},
    {"id":"12380","name":"P/0315/2013: EMA decision of 19 December 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 2R,6S,12Z,13aS,14aR,16aS)-N-(cyclopropylsulfonyl)-6-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/693866/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0315-2013-ema-decision-19-december-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2r6s12z13as14ar16as-n-cyclopropylsulfonyl-6_en.pdf"},
    {"id":"12381","name":"P/89/09: European medicines agency decision of 18 May 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for drospirenone / ethinylestradiol, betadex clathrate / L-5 methyltetrahydrofo...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/272661/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-89-09-european-medicines-agency-decision-18-may-2009-refusal-paediatric-investigation-plan-granting-waiver-drospirenone-ethinylestradiol-betadex-clathrate-l-5-methyltetrahydrofo_en.pdf"},
    {"id":"12414","name":"P/0246/2016: EMA decision of 12 September 2016 on the granting of a product specific waiver for allogeneic human neural stem cells genetically modified\n\nto express c-MycERTAM, a c-Myc and modified oestrogen receptor fusi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/557965/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2016-ema-decision-12-september-2016-granting-product-specific-waiver-allogeneic-human-neural-stem-cells-genetically-modified-express-c-mycertam-c-myc-modified-oestrogen-receptor-fusi_en.pdf"},
    {"id":"12462","name":"P/0174/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for Live, attenuated, chimeric dengue virus, serotype 1 / Live, attenuated, chimeric dengue virus,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/434507/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-live-attenuated-chimeric-dengue-virus-serotype-1-live-attenuated-chimeric-dengue-virus_en.pdf"},
    {"id":"12478","name":"P/175/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate\n\nmesilate (Pradaxa) (EMEA-000081-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/503627/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-175-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-mesilate-pradaxa-emea-000081-pip01-07-m03_en.pdf"},
    {"id":"12490","name":"P/0232/2013: EMA decision of 23 September 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for sapropterin dihydrochloride (Kuvan), (EMEA-001476-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/562037/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2013-ema-decision-23-september-2013-agreement-paediatric-investigation-plan-granting-waiver-sapropterin-dihydrochloride-kuvan-emea-001476-pip01-13_en.pdf"},
    {"id":"12496","name":"P/0223/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi, Ipreziv), (EMEA-000237-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/492667/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2013-ema-decision-23-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-azilsartan-medoxomil-edarbi-ipreziv-emea-000237-pip01-08-m05_en.pdf"},
    {"id":"12514","name":"P/0239/2014: EMA decision of 22 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for vortioxetine (Brintellix), (EMEA-000455-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-10-09T02:00:00Z","last_updated_date":"2014-10-09T02:00:00Z","reference_number":"EMA/391701/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2014-ema-decision-22-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-vortioxetine-brintellix-emea-000455-pip02-10-m02_en.pdf"},
    {"id":"12518","name":"P/0122/2012: EMA decision of 4 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza) (EMEA-000128-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/418254/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2012-ema-decision-4-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m04_en.pdf"},
    {"id":"12521","name":"P/0167/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP03-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/507290/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip03-11-m02_en.pdf"},
    {"id":"12527","name":"P/0058/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Prolia, Xgeva), (EMEA-000145-PIP02-12-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/104818/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-prolia-xgeva-emea-000145-pip02-12-m01_en.pdf"},
    {"id":"12532","name":"P/0089/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon alfa-2a (Pegasys) (EMEA-000298-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/206723/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-peginterferon-alfa-2a-pegasys-emea-000298-pip01-08-m03_en.pdf"},
    {"id":"12555","name":"P/0219/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol\n\n(hydrochloride) (Palexia, Yantil), (EMEA-000494-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/598561/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-yantil-emea-000494-pip01-08-m04_en.pdf"},
    {"id":"12564","name":"P/0009/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ocrelizumab (EMEA-\n\n000310-PIP03-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/38334/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-ocrelizumab-emea-000310-pip03-10-m02_en.pdf"},
    {"id":"12594","name":"P/0189/2017: EMA decision of 3 July 2017 on the granting of a product-specific waiver for rosuvastatin / amlodipine (EMEA-002130-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/348031/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2017-ema-decision-3-july-2017-granting-product-specific-waiver-rosuvastatin-amlodipine-emea-002130-pip01-17_en.pdf"},
    {"id":"12597","name":"P/0167/2013: EMA decision of 30 July on the acceptance of a modification of an agreed paediatric investigation plan for cobicistat (EMEA-\n\n000969-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/378738/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2013-ema-decision-30-july-acceptance-modification-agreed-paediatric-investigation-plan-cobicistat-emea-000969-pip01-10-m02_en.pdf"},
    {"id":"12608","name":"P/237/2011: EMA decision of 30 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for aliskiren (Rasilez and associated names) (EMEA-000362-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/708577/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-237-2011-ema-decision-30-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-aliskiren-rasilez-associated-names-emea-000362-pip01-08-m01_en.pdf"},
    {"id":"12624","name":"P/0062/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for trenonacog alfa (EMEA-000661-PIP01-09-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/138328/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0062-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-trenonacog-alfa-emea-000661-pip01-09-m07_en.pdf"},
    {"id":"12640","name":"P/33/2008: European medicines agency decision of 24 June 2008 on the application for agreement of a Paediatric Investigation Plan for tifacogin EMEA-000027- PIP01-07 in accordance with Regulation (EC) No 1901/2006","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/311526/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-33-2008-european-medicines-agency-decision-24-june-2008-application-agreement-paediatric-investigation-plan-tifacogin-emea-000027-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"12647","name":"P/0400/2017: EMA decision of 19 December 2017 on the refusal of a modification of an agreed paediatric investigation plan for recombinant human\n\nglutamic acid decarboxylase (rhGAD65) (EMEA-000609-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/797359/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0400-2017-ema-decision-19-december-2017-refusal-modification-agreed-paediatric-investigation-plan-recombinant-human-glutamic-acid-decarboxylase-rhgad65-emea-000609-pip01-09-m01_en.pdf"},
    {"id":"12648","name":"P/0221/2014: EMA decision of 3 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 4-{[(1R,2s,3S,5s,7s)-5-Hydroxy-2-adamantyl]amino}-1H...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/454986/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2014-ema-decision-3-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-4-1r2s3s5s7s-5-hydroxy-2-adamantylamino-1h_en.pdf"},
    {"id":"12657","name":"P/0003/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/776286/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0003-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-votubia-emea-000019-pip02-07-m05_en.pdf"},
    {"id":"12666","name":"P/0135/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pitolisant (Wakix), (EMEA-001176-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T02:00:00Z","last_updated_date":"2016-07-27T02:00:00Z","reference_number":"EMA/287396/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-pitolisant-wakix-emea-001176-pip01-11-m02_en.pdf"},
    {"id":"12690","name":"P/0300/2013: EMA decision of 29 November 2013 on the granting of a product specific waiver for amlodipine (besylate), perindopril (arginine), atorvastatin (calcium trihydrate) (EMEA-001496-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/705684/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2013-ema-decision-29-november-2013-granting-product-specific-waiver-amlodipine-besylate-perindopril-arginine-atorvastatin-calcium-trihydrate-emea-001496-pip01-13_en.pdf"},
    {"id":"12699","name":"P/315/2011: EMA decision of 22 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for atomoxetine (hydrochloride) (Strattera), (EMEA-00116...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/973117/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-315-2011-ema-decision-22-december-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-atomoxetine-hydrochloride-strattera-emea-00116_en.pdf"},
    {"id":"12711","name":"P/0158/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil (Revatio), (EMEA-000671-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/478172/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-revatio-emea-000671-pip01-09-m03_en.pdf"},
    {"id":"12714","name":"P/0217/2013: EMA decision of 6 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for exenatide (Byetta, Bydureon) (EMEA-000689-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/476175/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2013-ema-decision-6-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-exenatide-byetta-bydureon-emea-000689-pip01-09-m04_en.pdf"},
    {"id":"12738","name":"P/0267/2014: EMA decision of 16 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/592401/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2014-ema-decision-16-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-ambrisentan-volibris-emea-000434-pip01-08-m03_en.pdf"},
    {"id":"12779","name":"P/324/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M06) in","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/804453/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-324-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip01-08-m06_en.pdf"},
    {"id":"12783","name":"P/0017/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/23027/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m03_en.pdf"},
    {"id":"12794","name":"P/0201/2017: EMA decision of 14 July 2017 on the granting of a product-specific waiver for pexastimogene devacirepvec (EMEA-002124-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/444489/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2017-ema-decision-14-july-2017-granting-product-specific-waiver-pexastimogene-devacirepvec-emea-002124-pip01-17_en.pdf"},
    {"id":"12814","name":"P/199/2011: EMA decision of 4 August 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for lopinavir /\n\nritonavir (Kaletra), (EMEA-001005-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/603159/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-199-2011-ema-decision-4-august-2011-agreement-paediatric-investigation-plan-granting-waiver-lopinavir-ritonavir-kaletra-emea-001005-pip01-10_en.pdf"},
    {"id":"12816","name":"P/124/2008: European Medicines Agency decision of 5 December 2008 on the application for agreement of a Paediatric Investigation Plan for everolimus (Certican and associated names) EMEA-000019-PIP02-07 in accordance with...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/626873/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-124-2008-european-medicines-agency-decision-5-december-2008-application-agreement-paediatric-investigation-plan-everolimus-certican-associated-names-emea-000019-pip02-07-accordance_en.pdf"},
    {"id":"12820","name":"P/86/2011: EMA decision of 8 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for velaglucerase alfa (EMEA-000556-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/259113/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-86-2011-ema-decision-8-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-velaglucerase-alfa-emea-000556-pip01-09-m01_en.pdf"},
    {"id":"12830","name":"P/0277/2012: EMA decision of 21 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for EMEA-000673-PIP01-09-M06","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/723426/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0277-2012-ema-decision-21-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-emea-000673-pip01-09-m06_en.pdf"},
    {"id":"12883","name":"P/0250/2014: EMA decision of 30 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate) (EMEA-000788-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/527089/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2014-ema-decision-30-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-edoxaban-tosylate-emea-000788-pip02-11-m03_en.pdf"},
    {"id":"12924","name":"P/191/2010: European Medicines Agency decision of 15 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for cholic acid (EMEA-000651-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/478331/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-191-2010-european-medicines-agency-decision-15-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-cholic-acid-emea-000651-pip01-09-m01_en.pdf"},
    {"id":"12929","name":"P/0112/2017: EMA decision of 11 April 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for olodaterol\n\n(hydrochloride) (Striverdi Respimat), (EMEA-001965-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/181827/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2017-ema-decision-11-april-2017-agreement-paediatric-investigation-plan-granting-waiver-olodaterol-hydrochloride-striverdi-respimat-emea-001965-pip01-16_en.pdf"},
    {"id":"12940","name":"P/0193/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-me...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/354121/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2017-ema-decision-3-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-1-22-difluoro-13-benzodioxol-5-yl-n-1-2r-23-dihydroxypropyl-6-fluoro-2-1-hydroxy-2-me_en.pdf"},
    {"id":"12943","name":"P/0165/2012: EMA decision of 26 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for asunaprevir (EMEA-001190-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T16:00:00Z","last_updated_date":"2012-08-23T16:00:00Z","reference_number":"EMA/476808/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2012-ema-decision-26-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-asunaprevir-emea-001190-pip01-11_en.pdf"},
    {"id":"12944","name":"P/0158/2014: EMA decision of 18 June 2014 on the granting of a product specific waiver for metronidazole (in combination with amoxicillin + clarithromycin + pantoprazole) (EMEA-001615-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T14:20:00Z","last_updated_date":"2014-07-22T14:20:00Z","reference_number":"EMA/259620/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2014-ema-decision-18-june-2014-granting-product-specific-waiver-metronidazole-combination-amoxicillin-clarithromycin-pantoprazole-emea-001615-pip01-13_en.pdf"},
    {"id":"12984","name":"P/0206/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine\n\n(hydrochloride) (EDURANT), (EMEA-000317-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/472137/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m09_en.pdf"},
    {"id":"12986","name":"P/0041/2013: EMA decision of 25 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone dipropionate / formoterol fumarate dihydrate (Foster and associated names, Ka...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/104506/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0041-2013-ema-decision-25-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-beclometasone-dipropionate-formoterol-fumarate-dihydrate-foster-associated-names-ka_en.pdf"},
    {"id":"13002","name":"P/321/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for lisdexamfetamine (dimesylate) (EMEA-000553-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/775944/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-321-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-lisdexamfetamine-dimesylate-emea-000553-pip01-09-m04_en.pdf"},
    {"id":"13011","name":"P/73/2010: European Medicines Agency decision of 5 May 2010 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000454-PIP01-08-M01) in accordance with Reg...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/261595/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-73-2010-european-medicines-agency-decision-5-may-2010-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000454-pip01-08-m01-accordance-reg_en.pdf"},
    {"id":"13012","name":"P/0243/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for fidaxomicin (Dificlir), (EMEA-000636-PIP01-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T17:00:00Z","last_updated_date":"2017-10-25T17:00:00Z","reference_number":"EMA/507343/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-fidaxomicin-dificlir-emea-000636-pip01-09-m06_en.pdf"},
    {"id":"13013","name":"P/336/2010: EMA decision of 22 December 2010 on the granting of a product specific waiver for interferon alpha 2b (EMEA-001036-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-26T01:00:00Z","last_updated_date":"2011-01-26T01:00:00Z","reference_number":"EMA/683287/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-336-2010-ema-decision-22-december-2010-granting-product-specific-waiver-interferon-alpha-2b-emea-001036-pip01-10_en.pdf"},
    {"id":"13032","name":"P/0207/2015: EMA decision of 10 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta), (EMEA-000498-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/561311/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2015-ema-decision-10-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-trajenta-emea-000498-pip01-08-m05_en.pdf"},
    {"id":"13043","name":"P/231/2010:  EMA decision of 23 November 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for fentanyl citrate, (EMEA-000712-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/656702/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-231-2010-ema-decision-23-november-2010-agreement-paediatric-investigation-plan-granting-waiver-fentanyl-citrate-emea-000712-pip01-09_en.pdf"},
    {"id":"13044","name":"P/0156/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins (Xeomin, Bocoutur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/314185/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-clostridium-botulinum-neurotoxin-type-150-kd-free-complexing-proteins-xeomin-bocoutur_en.pdf"},
    {"id":"13047","name":"P/114/2011: EMA decision of 6 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil citrate\n\n(Revatio), (EMEA-000671-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/330172/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-114-2011-ema-decision-6-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-citrate-revatio-emea-000671-pip01-09-m01_en.pdf"},
    {"id":"13064","name":"P/119/2009: European Medicines Agency decision of 15 June 2009 on the granting of a product specific waiver for aliskiren hemifumarate / amlodipine besilate (EMEA-000516-PIP01-08) in accordance with Regulation (EC) No 19...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351842/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-119-2009-european-medicines-agency-decision-15-june-2009-granting-product-specific-waiver-aliskiren-hemifumarate-amlodipine-besilate-emea-000516-pip01-08-accordance-regulation-ec-no-19_en.pdf"},
    {"id":"13070","name":"P/82/2009: European medicines agency decision of 24 April 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for regadenoson (EMEA-000410-PIP01-08) in accordance with Regulation (E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2006-06-10T02:00:00Z","last_updated_date":"2006-06-10T02:00:00Z","reference_number":"EMEA/231051/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-82-2009-european-medicines-agency-decision-24-april-2009-agreement-paediatric-investigation-plan-granting-deferral-regadenoson-emea-000410-pip01-08-accordance-regulation-e_en.pdf"},
    {"id":"13083","name":"P/200/2010: European Medicines Agency decision of  27 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for Sodium-X-5-Hydroxy-X-6,10-dioxo-3,4,5,6,9,9a,10-hexahydro-2H-1-oxa-4a,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/650005/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-200-2010-european-medicines-agency-decision-27-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-sodium-x-5-hydroxy-x-610-dioxo-345699a10-hexahydro-2h-1-oxa-4a_en.pdf"},
    {"id":"13107","name":"P/94/2008: European medicines agency decision of 3 November 2008\n\non the application for agreement of a Paediatric Investigation Plan for vandetanib, EMEA-000052-PIP01-07 in accordance with Regulation (EC) No 1901/2006 o...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-07T00:00:00Z","last_updated_date":"2009-01-07T00:00:00Z","reference_number":"EMEA/562638/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-94-2008-european-medicines-agency-decision-3-november-2008-application-agreement-paediatric-investigation-plan-vandetanib-emea-000052-pip01-07-accordance-regulation-ec-no-1901-2006-o_en.pdf"},
    {"id":"13163","name":"P/0041/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for albiglutide, (Eperzan) (EMEA-001175-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/89509/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0041-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-albiglutide-eperzan-emea-001175-pip01-11-m02_en.pdf"},
    {"id":"13167","name":"P/185/2011: EMA decision of 4 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia) (EMEA-000495-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/601930/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-185-2011-ema-decision-4-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-emea-000495-pip01-08-m03_en.pdf"},
    {"id":"13182","name":"P/0323/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel(Fycompa), (EMEA-000467-PIP01-08-M08)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T11:23:00Z","last_updated_date":"2017-01-30T11:23:00Z","reference_number":"EMA/741982/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0323-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-perampanelfycompa-emea-000467-pip01-08-m08_en.pdf"},
    {"id":"13195","name":"P/0210/2013: EMA decision of 3 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for cangrelor (tetrasodium), (EMEA-001348-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"EMA/466068/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2013-ema-decision-3-september-2013-agreement-paediatric-investigation-plan-granting-deferral-cangrelor-tetrasodium-emea-001348-pip01-12_en.pdf"},
    {"id":"13206","name":"P/0195/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/456074/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2013-ema-decision-2-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip01-07-m05_en.pdf"},
    {"id":"13212","name":"P/0165/2014: EMA decision of 27 June 2014 on the granting of a product specific waiver for aflibercept (Eylea), (EMEA-000236-PIP04-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-31T12:00:00Z","last_updated_date":"2014-07-31T12:00:00Z","reference_number":"EMA/356633/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2014-ema-decision-27-june-2014-granting-product-specific-waiver-aflibercept-eylea-emea-000236-pip04-14_en.pdf"},
    {"id":"13238","name":"P/79/2008: European medicines agency decision of 15 September 2007 on the application for product specific waiver for prilocaine, lidocaine (EMEA-000248-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Eu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-10-10T02:00:00Z","last_updated_date":"2008-10-10T02:00:00Z","reference_number":"EMEA/471376/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-79-2008-european-medicines-agency-decision-15-september-2007-application-product-specific-waiver-prilocaine-lidocaine-emea-000248-pip01-08-accordance-regulation-ec-no-1901-2006-eu_en.pdf"},
    {"id":"13240","name":"P/0224/2012: EMA decision of 1 October 2012 on the granting of a product specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294-\n\nPIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/568807/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2012-ema-decision-1-october-2012-granting-product-specific-waiver-azilsartan-medoxomil-chlortalidone-emea-001294-pip01-12_en.pdf"},
    {"id":"13244","name":"P/218/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 12 grass pollen extract, cultiva...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/615624/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-218-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-12-grass-pollen-extract-cultiva_en.pdf"},
    {"id":"13276","name":"P/0040/2016: EMA decision of 19 February 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for nivolumab (Opdivo), (EMEA-001407-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/103118/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2016-ema-decision-19-february-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-nivolumab-opdivo-emea-001407-pip02-15_en.pdf"},
    {"id":"13287","name":"P/0102/2012: EMA decision of 30 May 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for agomelatine (Valdoxan, Thymanax), (EMEA-001181-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/230119/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2012-ema-decision-30-may-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-agomelatine-valdoxan-thymanax-emea-001181-pip01-11_en.pdf"},
    {"id":"13302","name":"P/0030/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for amikacin (sulfate) (EMEA-000525-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/44366/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-amikacin-sulfate-emea-000525-pip01-08-m04_en.pdf"},
    {"id":"13318","name":"P/0196/2016: EMA decision of 15 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emicizumab (EMEA-001839-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/387121/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2016-ema-decision-15-july-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-emicizumab-emea-001839-pip01-15_en.pdf"},
    {"id":"13323","name":"P/0187/2017: EMA decision of 3 July 2017 on the granting of a product specific waiver for miridesap (EMEA-002111-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/354129/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2017-ema-decision-3-july-2017-granting-product-specific-waiver-miridesap-emea-002111-pip02-17_en.pdf"},
    {"id":"13328","name":"P/0231/2013: EMA decision of 23 September 2013 on the granting of a product specific waiver for valsartan / atorvastatin (EMEA-001472-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/492660/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2013-ema-decision-23-september-2013-granting-product-specific-waiver-valsartan-atorvastatin-emea-001472-pip01-13_en.pdf"},
    {"id":"13332","name":"P/0260/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+\n\ncells transduced with lentiviral vector containing the human Wiskott Aldric...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585489/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-wiskott-aldric_en.pdf"},
    {"id":"13360","name":"P/310/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of birch pollen (EMEA-00093...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/697312/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-310-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-birch-pollen-emea-00093_en.pdf"},
    {"id":"13362","name":"P/20/2009: European Medicines Agency decision of of 6 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for anastrozole, Arimidex and associated names (EMEA-000283-PIP-01-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/64242/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-20-2009-european-medicines-agency-decision-6-february-2009-agreement-paediatric-investigation-plan-granting-waiver-anastrozole-arimidex-associated-names-emea-000283-pip-01-0_en.pdf"},
    {"id":"13411","name":"P/0104/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for treosulfan (EMEA-000883-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/202483/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0104-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-treosulfan-emea-000883-pip01-10-m01_en.pdf"},
    {"id":"13417","name":"P/0140/2014: EMA decision of 11 June 2014 on the refusal of a paediatric investigation plan and on the granting of a waiver for doxylamine (succinate) / pyridoxine (hydrochloride) (EMEA-001608-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/275220/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2014-ema-decision-11-june-2014-refusal-paediatric-investigation-plan-granting-waiver-doxylamine-succinate-pyridoxine-hydrochloride-emea-001608-pip01-13_en.pdf"},
    {"id":"13430","name":"P/0254/2014: EMA decision of 30 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for solithromycin (EMEA-001581-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/528092/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0254-2014-ema-decision-30-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-solithromycin-emea-001581-pip01-13_en.pdf"},
    {"id":"13436","name":"P/323/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (Edurant), (EMEA-000317-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/738887/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-323-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m05_en.pdf"},
    {"id":"13442","name":"P/0296/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (EMEA-\n\n001113-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/708157/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0296-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-delamanid-emea-001113-pip01-10-m02_en.pdf"},
    {"id":"13464","name":"P/0037/2013: EMA decision of 27 February 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for azithromycin (EMEA-001298-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/75623/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2013-ema-decision-27-february-2013-agreement-paediatric-investigation-plan-granting-waiver-azithromycin-emea-001298-pip01-12_en.pdf"},
    {"id":"13486","name":"P/101/2009: European Medicines Agency decision of 19 May 2009 on the granting of a product specific waiver for cladribine (EMEA-000383-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliament ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/290924/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-101-2009-european-medicines-agency-decision-19-may-2009-granting-product-specific-waiver-cladribine-emea-000383-pip01-08-accordance-regulation-ec-no-1901-2006-european-parliament_en.pdf"},
    {"id":"13487","name":"P/178/2011: EMA decision of 26 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for asenapine (maleate)\n\n(Sycrest), (EMEA-000228-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/670593/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-178-2011-ema-decision-26-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-asenapine-maleate-sycrest-emea-000228-pip01-08-m02_en.pdf"},
    {"id":"13494","name":"P/0158/2017: EMA decision of 29 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla),\n\n(EMEA-000715-PIP05-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/394680/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2017-ema-decision-29-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip05-13-m01_en.pdf"},
    {"id":"13495","name":"P/0087/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium) (EMEA-000205-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/206620/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0087-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-ceftobiprole-medocaril-sodium-emea-000205-pip01-08-m02_en.pdf"},
    {"id":"13578","name":"P/315/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass pollen (EMEA-00094...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769460/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-315-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-pollen-emea-00094_en.pdf"},
    {"id":"13604","name":"P/103/2011: EMA decision of 3 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa (Ruconest) (EMEA-000367-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/247030/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-103-2011-ema-decision-3-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-conestat-alfa-ruconest-emea-000367-pip01-08-m01_en.pdf"},
    {"id":"13626","name":"P/0055/2016: EMA decision of 18 March 2016 on the granting of a product specific waiver for fluoroestradiol (18F) (EMEA-001892-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/90033/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2016-ema-decision-18-march-2016-granting-product-specific-waiver-fluoroestradiol-18f-emea-001892-pip01-15_en.pdf"},
    {"id":"13642","name":"P/0025/2012: EMA decision of 27 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for human fibrinogen / human thrombin (Evicel), (EMEA-00...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/987057/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2012-ema-decision-27-january-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-fibrinogen-human-thrombin-evicel-emea-00_en.pdf"},
    {"id":"13650","name":"P/0248/2012: EMA decision of 23 October 2012 on the granting of a product-specific waiver for folic acid (EMEA-001321-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/587247/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0248-2012-ema-decision-23-october-2012-granting-product-specific-waiver-folic-acid-emea-001321-pip01-12_en.pdf"},
    {"id":"13672","name":"P/144/2011: EMA decision of 9 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chemically modified extract of trees pollen from birch and...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/417339/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-144-2011-ema-decision-9-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chemically-modified-extract-trees-pollen-birch_en.pdf"},
    {"id":"13687","name":"P/0131/2016: EMA decision of 20 May 2016on the acceptance of a modification of an agreed paediatric investigation plan for vorapaxar (EMEA-000778-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/269206/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2016-ema-decision-20-may-2016on-acceptance-modification-agreed-paediatric-investigation-plan-vorapaxar-emea-000778-pip02-12-m01_en.pdf"},
    {"id":"13712","name":"P/0261/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eftrenonacog alfa\n\n(ALPROLIX), (EMEA-000914-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585499/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0261-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-eftrenonacog-alfa-alprolix-emea-000914-pip01-10-m03_en.pdf"},
    {"id":"13716","name":"P/0134/2013: EMA decision of 14 June 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for isavuconazonium (sulfate) (EMEA-001301-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/313498/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0134-2013-ema-decision-14-june-2013-agreement-paediatric-investigation-plan-granting-deferral-isavuconazonium-sulfate-emea-001301-pip01-12_en.pdf"},
    {"id":"13729","name":"P/124/2010: European Medicines Agency decision of 28 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for voclosporin (EMEA-000132-PIP01-07-M02) in accordance with Regulation (EC) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/463403/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-124-2010-european-medicines-agency-decision-28-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-voclosporin-emea-000132-pip01-07-m02-accordance-regulation-ec_en.pdf"},
    {"id":"13766","name":"P/0068/2012: EMA decision of 4 April 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rituximab (MabThera), (EMEA-000308-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-27T13:00:00Z","last_updated_date":"2012-04-27T13:00:00Z","reference_number":"EMA/215413/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2012-ema-decision-4-april-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rituximab-mabthera-emea-000308-pip02-11_en.pdf"},
    {"id":"13769","name":"P/0081/2017: EMA decision of 17 March 2017 on the granting of a product specific waiver for atorvastatin (calcium) / ezetimibe (EMEA-002047-\n\nPIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/104150/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2017-ema-decision-17-march-2017-granting-product-specific-waiver-atorvastatin-calcium-ezetimibe-emea-002047-pip01-16_en.pdf"},
    {"id":"13777","name":"P/0191/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for eliglustat (tartrate) (Cerdelga), (EMEA-000461-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/505296/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-eliglustat-tartrate-cerdelga-emea-000461-pip02-11-m01_en.pdf"},
    {"id":"13792","name":"P/45/2007: European medicines agency decision of 23 June 2008\n\non the application for agreement of a Paediatric Investigation Plan for Nicotinic acid and laropiprant (EMEA-000251-PIP01-08) in accordance with Regulation (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/315694/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-45-2007-european-medicines-agency-decision-23-june-2008-application-agreement-paediatric-investigation-plan-nicotinic-acid-laropiprant-emea-000251-pip01-08-accordance-regulation_en.pdf"},
    {"id":"13794","name":"P/0068/2017: EMA decision of 17 March 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for somapacitan (EMEA-001469-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/104169/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2017-ema-decision-17-march-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-somapacitan-emea-001469-pip01-13_en.pdf"},
    {"id":"13812","name":"P/0122/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (EMEA-\n\n001521-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/141787/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-luspatercept-emea-001521-pip01-13-m02_en.pdf"},
    {"id":"13826","name":"P/170/2011: EMA decision of 8 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for fosaprepitant\n\n(Ivemend), (EMEA-000406-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/387079/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-170-2011-ema-decision-8-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-fosaprepitant-ivemend-emea-000406-pip01-08-m02_en.pdf"},
    {"id":"13841","name":"P/0220/2013: EMA decision of 6 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for valganciclovir (Valcyte and associated names), (EMEA-000726-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/496855/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2013-ema-decision-6-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-valganciclovir-valcyte-associated-names-emea-000726-pip01-09-m02_en.pdf"},
    {"id":"13899","name":"P/0011/2016: EMA decision of 29 January 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for osilodrostat (EMEA-000315-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/2821/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2016-ema-decision-29-january-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-osilodrostat-emea-000315-pip02-15_en.pdf"},
    {"id":"13906","name":"P/0135/2017: EMA decision of 7 June 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for pimodivir (EMEA-001975-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/312727/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2017-ema-decision-7-june-2017-agreement-paediatric-investigation-plan-granting-deferral-pimodivir-emea-001975-pip01-16_en.pdf"},
    {"id":"13930","name":"P/0097/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (RS)-Bacoflen / naltrexone HCl / D-Sorbitol (PXT3003) (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/112469/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rs-bacoflen-naltrexone-hcl-d-sorbitol-pxt3003_en.pdf"},
    {"id":"13937","name":"P/0009/2013: EMA decision of 22 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir sulphate (Reyataz), (EMEA-000804-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/21189/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2013-ema-decision-22-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-atazanavir-sulphate-reyataz-emea-000804-pip01-09-m01_en.pdf"},
    {"id":"13951","name":"P/137/2009: European Medicines Agency decision of 15 July 2009 on the agreement of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for fosaprepitant dimeglumine (Ivemend) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/416941/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-137-2009-european-medicines-agency-decision-15-july-2009-agreement-paediatric-investigation-plan-refusal-deferral-granting-waiver-fosaprepitant-dimeglumine-ivemend_en.pdf"},
    {"id":"13960","name":"P/0368/2017: EMA decision of 1 December 2017 on the granting of a product specific waiver for vonapanitase (EMEA-002195-PIP01-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T14:03:00Z","last_updated_date":"2018-03-07T14:03:00Z","reference_number":"EMA/711132/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0368-2017-ema-decision-1-december-2017-granting-product-specific-waiver-vonapanitase-emea-002195-pip01-17_en.pdf"},
    {"id":"13965","name":"P/0158/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for naloxegol (EMEA-001146-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/314193/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-naloxegol-emea-001146-pip01-11-m02_en.pdf"},
    {"id":"14009","name":"P/20/2008: European medicines agency decision of  28 April 2008 on the application for product specific waiver for flibanserin, EMEA-000085-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the European Parliam...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-05-16T02:00:00Z","last_updated_date":"2008-05-16T02:00:00Z","reference_number":"EMEA/212132/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-20-2008-european-medicines-agency-decision-28-april-2008-application-product-specific-waiver-flibanserin-emea-000085-pip01-07-accordance-regulation-ec-no-1901-2006-european-parliam_en.pdf"},
    {"id":"14033","name":"P/21/2009: European Medicines Agency decision of 23 February 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a waiver for candesartan cilexetil (Atacand and associated name), (EMEA-000021-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/95694/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-21-2009-european-medicines-agency-decision-23-february-2009-refusal-paediatric-investigation-plan-refusal-waiver-candesartan-cilexetil-atacand-associated-name-emea-000021-pip_en.pdf"},
    {"id":"14046","name":"P/165/2011: EMA decision of 4 July 2011 on the granting of a product specific waiver for alogliptin (benzoate) / metformin (hydrochloride)\n\n(EMEA-001128-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/423967/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-165-2011-ema-decision-4-july-2011-granting-product-specific-waiver-alogliptin-benzoate-metformin-hydrochloride-emea-001128-pip01-10_en.pdf"},
    {"id":"14052","name":"P/101/2011: EMA decision of 11 April 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for darbepoetin\n\nalfa (Aranesp) (EMEA-000329-PIP02-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/278715/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-101-2011-ema-decision-11-april-2011-agreement-paediatric-investigation-plan-granting-waiver-darbepoetin-alfa-aranesp-emea-000329-pip02-09_en.pdf"},
    {"id":"14078","name":"P/0136/2013: EMA decision of 14 June 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for phenylephrine hydrochloride / ketorolac trometamol (OMS3...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/306111/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2013-ema-decision-14-june-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-phenylephrine-hydrochloride-ketorolac-trometamol-oms3_en.pdf"},
    {"id":"14087","name":"P/0002/2013: EMA decision of 18 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tigecycline (Tygacil), (EMEA-000120-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/795743/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2013-ema-decision-18-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-tigecycline-tygacil-emea-000120-pip01-07-m03_en.pdf"},
    {"id":"14094","name":"P/0042/2017: European Medicines Agency decision of 30 January 2017 on the granting of a product specific waiver for (1S, 3S, 4R)-4-[(3aS, 4R, 5S,7aS)-4-(aminomethyl)-7a-methyl-1-methylidene-octahydro-1H-inden-5-yl]-3-(hy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/2919/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2017-european-medicines-agency-decision-30-january-2017-granting-product-specific-waiver-1s-3s-4r-4-3as-4r-5s7as-4-aminomethyl-7a-methyl-1-methylidene-octahydro-1h-inden-5-yl-3-hy_en.pdf"},
    {"id":"14098","name":"P/62/2008: European medicines agency decision of 14 August 2008\n\non the application for agreement of a Paediatric Investigation Plan for thrombin alfa EMEA-000163-PIP01-07 in accordance with Regulation (EC) No 1901/2006 ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/421270/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-62-2008-european-medicines-agency-decision-14-august-2008-application-agreement-paediatric-investigation-plan-thrombin-alfa-emea-000163-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"14137","name":"P/0016/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin (Jardiance) (EMEA-000828-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/793465/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-empagliflozin-jardiance-emea-000828-pip01-09-m03_en.pdf"},
    {"id":"14138","name":"P/0190/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for vortioxetine (Brintellix), (EMEA-000455-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/571186/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-vortioxetine-brintellix-emea-000455-pip02-10-m03_en.pdf"},
    {"id":"14152","name":"P/0025/2013: EMA decision of 26 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for C1 inhibitor (Cinryze) (EMEA-000568-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/89687/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2013-ema-decision-26-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-c1-inhibitor-cinryze-emea-000568-pip01-09-m04_en.pdf"},
    {"id":"14159","name":"P/9/2008: European medicines agency decision of 29 February 2008 on the application for agreement of a Paediatric Investigation Plan for Cozaar and associated names, losartan potassium EMEA-000008-PIP01-07 in accordance ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-03-19T01:00:00Z","last_updated_date":"2008-03-19T01:00:00Z","reference_number":"EMEA/96630/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-9-2008-european-medicines-agency-decision-29-february-2008-application-agreement-paediatric-investigation-plan-cozaar-associated-names-losartan-potassium-emea-000008-pip01-07-accordance_en.pdf"},
    {"id":"14162","name":"P/0207/2014: EMA decision of 8 August 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for valaciclovir  (hydrochloride) (EMEA-001548-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/433934/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2014-ema-decision-8-august-2014-agreement-paediatric-investigation-plan-granting-waiver-valaciclovir-hydrochloride-emea-001548-pip01-13_en.pdf"},
    {"id":"14204","name":"P/0033/2017: European Medicines Agency decision of 31 January 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for autologous CD34+ cells transduced with lentiviral vector encoding...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/12300/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2017-european-medicines-agency-decision-31-january-2017-agreement-paediatric-investigation-plan-granting-waiver-autologous-cd34-cells-transduced-lentiviral-vector-encoding_en.pdf"},
    {"id":"14218","name":"P/0181/2017: EMA decision of 30 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir / cobicistat (Evotaz), (EMEA-001465-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/370810/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2017-ema-decision-30-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-atazanavir-cobicistat-evotaz-emea-001465-pip01-13-m01_en.pdf"},
    {"id":"14227","name":"P/44/2012: EMA decision of 28 February 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]- ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/131595/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-44-2012-ema-decision-28-february-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-n-3-3-cyclopropyl-5-2-fluoro-4-iodophenylamino_en.pdf"},
    {"id":"14241","name":"P/0154/2017: EMA decision of 2 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat), (EMEA-000402-PIP02-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/341236/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2017-ema-decision-2-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-lacosamide-vimpat-emea-000402-pip02-11-m04_en.pdf"},
    {"id":"14242","name":"P/0023/2013: EMA decision of 25 February 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for eribulin (Halaven), (EMEA-001261-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/51372/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2013-ema-decision-25-february-2013-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-eribulin-halaven-emea-001261-pip01-11_en.pdf"},
    {"id":"14248","name":"P/0344/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (EDURANT) (EMEA-000317-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/785324/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0344-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m07_en.pdf"},
    {"id":"14253","name":"P/0031/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tedizolid (phosphate)\n\n(Sivextro), (EMEA-001379-PIP01-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/848775/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0031-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-tedizolid-phosphate-sivextro-emea-001379-pip01-12-m03_en.pdf"},
    {"id":"14300","name":"P/88/2010: European Medicines Agency decision of 1 June 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for beclometasone dipropionate / formoter...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/335695/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-88-2010-european-medicines-agency-decision-1-june-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-beclometasone-dipropionate-formoter_en.pdf"},
    {"id":"14308","name":"P/0223/2014: EMA decision of 5 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin (EMEA-000016-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/464831/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2014-ema-decision-5-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-dalbavancin-emea-000016-pip01-07-m03_en.pdf"},
    {"id":"14315","name":"P/0089/2014: EMA decision of 4 April 2014 on the granting of a product specific waiver for atropine (sulphate) / dimethanesulfonate / avizafone (hydrochloride) (EMEA-001586-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T14:00:00Z","last_updated_date":"2014-05-13T14:00:00Z","reference_number":"EMA/122781/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2014-ema-decision-4-april-2014-granting-product-specific-waiver-atropine-sulphate-dimethanesulfonate-avizafone-hydrochloride-emea-001586-pip01-13_en.pdf"},
    {"id":"14325","name":"P/269/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for insulin detemir (Levemir) (EMEA-000412-PIP01-08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-10T01:00:00Z","last_updated_date":"2011-01-10T01:00:00Z","reference_number":"EMA/735668/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-269-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-insulin-detemir-levemir-emea-000412-pip01-08_en.pdf"},
    {"id":"14341","name":"P/0146/2016: EMA decision of 27 May 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant humanized anti-MMP9 monoclonal antibody IgG4 ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/337422/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0146-2016-ema-decision-27-may-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-humanized-anti-mmp9-monoclonal-antibody-igg4_en.pdf"},
    {"id":"14358","name":"P/0083/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan for autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/107868/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-autologous-cd34-enriched-cell-fraction-contains-cd34-cells-transduced-lentiviral-vector-encodes_en.pdf"},
    {"id":"14361","name":"P/0196/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil (Revatio), (EMEA-000671-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/390359/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-revatio-emea-000671-pip01-09-m05_en.pdf"},
    {"id":"14382","name":"P/0239/2016: EMA decision of 9 September 2016 on the granting of a product specific waiver for lesinurad / allopurinol, (EMEA-001952-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/580049/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2016-ema-decision-9-september-2016-granting-product-specific-waiver-lesinurad-allopurinol-emea-001952-pip01-16_en.pdf"},
    {"id":"14390","name":"P/0165/2013: EMA decision of 29 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil (Revatio), (EMEA-000671-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/393007/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2013-ema-decision-29-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-revatio-emea-000671-pip01-09-m04_en.pdf"},
    {"id":"14426","name":"P/0281/2013: EMA decision of 8 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-12-06T01:00:00Z","last_updated_date":"2013-12-06T01:00:00Z","reference_number":"EMA/670626/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0281-2013-ema-decision-8-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"14493","name":"P/0263/2012: EMA decision of of 20 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for methoxy polyethylene glycol-epoetin beta (Mircera), (EMEA-000172-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/646943/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0263-2012-ema-decision-20-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-methoxy-polyethylene-glycol-epoetin-beta-mircera-emea-000172-pip01-07-m01_en.pdf"},
    {"id":"14524","name":"P/93/2008: European medicines agency decision of 22 October 2008\n\non the application for agreement of a Paediatric Investigation Plan for Nalfurafine Hydrochloride, EMEA-000266-PIP01-08 in accordance with Regulation (EC)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/540588/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-93-2008-european-medicines-agency-decision-22-october-2008-application-agreement-paediatric-investigation-plan-nalfurafine-hydrochloride-emea-000266-pip01-08-accordance-regulation-ec_en.pdf"},
    {"id":"14529","name":"P/0352/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab\n\n(Cosentyx) (EMEA-000380-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/724324/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0352-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-secukinumab-cosentyx-emea-000380-pip01-08-m04_en.pdf"},
    {"id":"14537","name":"P/112/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for 3-(1H-indol-3-yl)-4-(2-(4-methyl-1-piperazinyl)-4-quinazolinyl)-1H-pyrrole-2,5-dio...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/624134/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-112-2008-european-medicines-agency-decision-1-december-2008-application-agreement-paediatric-investigation-plan-3-1h-indol-3-yl-4-2-4-methyl-1-piperazinyl-4-quinazolinyl-1h-pyrrole-25-dio_en.pdf"},
    {"id":"14581","name":"P/0152/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion influenza H5N1 (Prepandrix, Pandemic inf...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/480054/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-purified-antigen-fractions-inactivated-split-virion-influenza-h5n1-prepandrix-pandemic-inf_en.pdf"},
    {"id":"14607","name":"P/0317/2015: EMA decision of 21 December 2015 on the granting of a product-specific waiver for ketoprofen (EMEA-001783-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/807033/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0317-2015-ema-decision-21-december-2015-granting-product-specific-waiver-ketoprofen-emea-001783-pip02-15_en.pdf"},
    {"id":"14618","name":"P/0245/2014: EMA decision of 29 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant soluble fusion protein with a modified ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/527327/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2014-ema-decision-29-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-soluble-fusion-protein-modified_en.pdf"},
    {"id":"14659","name":"P/212/2011: EMA decision of 2 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for veliparib (EMEA-000499-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/654593/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-212-2011-ema-decision-2-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-veliparib-emea-000499-pip02-10_en.pdf"},
    {"id":"14662","name":"P/0174/2014: EMA decision of 11 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tafluprost (Taflotan and associated names), (EMEA-001187-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/314400/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2014-ema-decision-11-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-tafluprost-taflotan-associated-names-emea-001187-pip01-11-m01_en.pdf"},
    {"id":"14692","name":"P/0017/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for paclitaxel Abraxane), (EMEA-001308-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/34936/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-paclitaxel-abraxane-emea-001308-pip01-12-m01_en.pdf"},
    {"id":"14702","name":"P/0261/2014: EMA decision of 29 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names), (EMEA-000573-PIP02-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/586420/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0261-2014-ema-decision-29-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip02-13-m02_en.pdf"},
    {"id":"14704","name":"P/92/2008: European medicines agency decision of 14 October 2008 on the application for agreement of a Paediatric Investigation Plan for peginterferon alfa-2b (ViraferonPeg) (EMEA-000384-PIP01-08) in accordance with Regu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/527764/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-92-2008-european-medicines-agency-decision-14-october-2008-application-agreement-paediatric-investigation-plan-peginterferon-alfa-2b-viraferonpeg-emea-000384-pip01-08-accordance-regu_en.pdf"},
    {"id":"14708","name":"P/0291/2014: EMA decision of 24 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / vilanterol (Relvar Ellipta and associated names), (EMEA-000431-PIP01-0...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/640503/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0291-2014-ema-decision-24-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-vilanterol-relvar-ellipta-associated-names-emea-000431-pip01-0_en.pdf"},
    {"id":"14714","name":"P/0222/2014: EMA decision of 3 September 2014 on the refusal of a product specific waiver for (R)-2-[3-({Benzoxazol-2-yl[3-(4-methoxyphenoxy)propyl]amino}methyl)phenoxy]butanoic acid (EMEA-001573-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/514822/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2014-ema-decision-3-september-2014-refusal-product-specific-waiver-r-2-3-benzoxazol-2-yl3-4-methoxyphenoxypropylaminomethylphenoxybutanoic-acid-emea-001573-pip01-13_en.pdf"},
    {"id":"14716","name":"P/0209/2017: EMA decision of 9 August 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for influenza virus surface antigens (haemagglutinin and ne...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/458748/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2017-ema-decision-9-august-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-surface-antigens-haemagglutinin-ne_en.pdf"},
    {"id":"14741","name":"P/55/2009: European Medicines Agency decision of 24 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for tapentadol hydrochloride (EMEA-000485-PIP01-08) in accordance with ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/161790/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-55-2009-european-medicines-agency-decision-24-march-2009-agreement-paediatric-investigation-plan-granting-deferral-tapentadol-hydrochloride-emea-000485-pip01-08-accordance_en.pdf"},
    {"id":"14744","name":"P/0189/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for caplacizumab (EMEA-\n\n001157-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:13:00Z","last_updated_date":"2016-09-22T16:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-caplacizumab-emea-001157-pip01-11-m01_en.pdf"},
    {"id":"14745","name":"P/0043/2017: European Medicines Agency decision of 31 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for varicella-zoster virus (inactiv...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/12299/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2017-european-medicines-agency-decision-31-january-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-varicella-zoster-virus-inactiv_en.pdf"},
    {"id":"14758","name":"P/0338/2017: EMA decision of 10 November 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for crisaborole (EMEA-002065-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/666639/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0338-2017-ema-decision-10-november-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-crisaborole-emea-002065-pip01-16_en.pdf"},
    {"id":"14768","name":"P/0055/2015: EMA decision of 30 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human N-acetylgalactosamine-6-sulfatase (BMN110) Vimizim (elosulfase alfa) (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/195738/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2015-ema-decision-30-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-n-acetylgalactosamine-6-sulfatase-bmn110-vimizim-elosulfase-alfa-emea-0_en.pdf"},
    {"id":"14778","name":"P/252/2009: European Medicines Agency decision of 22 December 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for house dust mites allergen extract (EMEA-000319-PIP01-08-M01) in accord...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-01-25T00:00:00Z","last_updated_date":"2010-01-25T00:00:00Z","reference_number":"EMA/816085/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-252-2009-european-medicines-agency-decision-22-december-2009-acceptance-modification-agreed-paediatric-investigation-plan-house-dust-mites-allergen-extract-emea-000319-pip01-08-m01-accord_en.pdf"},
    {"id":"14784","name":"P/173/2010: European Medicines Agency decision of 17 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for romiplostim (Nplate), (EMEA-00...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/558114/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-173-2010-european-medicines-agency-decision-17-september-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-romiplostim-nplate-emea-00_en.pdf"},
    {"id":"14852","name":"P/0220/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol\n\n(hydrochloride) (Palexia, Yantil), (EMEA-000495-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/598593/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-yantil-emea-000495-pip01-08-m04_en.pdf"},
    {"id":"14854","name":"P/0254/2016: EMA decision of 55 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis),\n\n(EMEA-000183-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585767/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0254-2016-ema-decision-55-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip01-08-m04_en.pdf"},
    {"id":"14878","name":"P/0127/2014: EMA decision of 22 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-25T02:00:00Z","last_updated_date":"2014-06-25T02:00:00Z","reference_number":"EMA/289586/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2014-ema-decision-22-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-emea-000332-pip01-08-m08_en.pdf"},
    {"id":"14879","name":"P/0322/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T11:23:00Z","last_updated_date":"2017-01-30T11:23:00Z","reference_number":"EMA/757940/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0322-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-ambrisentan-volibris-emea-000434-pip01-08-m04_en.pdf"},
    {"id":"14900","name":"P/21/2011: EMA decision of 25 January 2011 on the acceptance of a modification of an agreed Paediatric Investigation Plan for exenatide (Byetta) (EMEA-000689-PIP01-09-M02) in accordance with Regulation (EC) No 1901/2006 ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-02-26T00:09:21Z","last_updated_date":"2011-02-25T00:09:21Z","reference_number":"EMA/26216/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-21-2011-ema-decision-25-january-2011-acceptance-modification-agreed-paediatric-investigation-plan-exenatide-byetta-emea-000689-pip01-09-m02-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"14911","name":"P/295/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pollen from betula verrucosa, (EMEA-000846-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683397/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-295-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-betula-verrucosa-emea-000846-pip01-10_en.pdf"},
    {"id":"14917","name":"P/237/2010:  EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human monoclonal antibody to human Inter...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/703761/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-237-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-monoclonal-antibody-human-inter_en.pdf"},
    {"id":"14931","name":"P/0064/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/153838/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2015-ema-decision-1-april-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dapagliflozin-forxiga-emea-000694-pip02-14_en.pdf"},
    {"id":"14949","name":"P/275/2011: EMA decision of 11 November 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for delamanid\n\n(EMEA-001113-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T12:15:00Z","last_updated_date":"2011-12-21T12:15:00Z","reference_number":"EMA/700668/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-275-2011-ema-decision-11-november-2011-agreement-paediatric-investigation-plan-granting-deferral-delamanid-emea-001113-pip01-10_en.pdf"},
    {"id":"14971","name":"P/0122/2013: EMA decision of 28 May 2013 on the acceptance of a modification of an agreed paediatric investigation plan for concentrate of proteolytic enzymes in bromelain (NexoBrid), (EMEA-000142-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-21T13:30:00Z","last_updated_date":"2013-06-21T13:30:00Z","reference_number":"EMA/248970/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2013-ema-decision-28-may-2013-acceptance-modification-agreed-paediatric-investigation-plan-concentrate-proteolytic-enzymes-bromelain-nexobrid-emea-000142-pip02-09-m01_en.pdf"},
    {"id":"14976","name":"P/0346/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for thrombomodulin alfa\n\n(EMEA-001363-PIP01-12-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T11:48:00Z","last_updated_date":"2018-03-02T11:48:00Z","reference_number":"EMA/709640/2017 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0346-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-thrombomodulin-alfa-emea-001363-pip01-12-m01_en.pdf"},
    {"id":"14979","name":"P/0152/2016: EMA decision of 14 June 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for (EMEA-001832-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/347828/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2016-ema-decision-14-june-2016-agreement-paediatric-investigation-plan-granting-deferral-emea-001832-pip01-15_en.pdf"},
    {"id":"14983","name":"P/0277/2013: EMA decision of 24 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec (Tresiba) (EMEA-000456-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/646736/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0277-2013-ema-decision-24-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-insulin-degludec-tresiba-emea-000456-pip01-08-m01_en.pdf"},
    {"id":"14998","name":"P/0072/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for pegylated human recombinant factor VIII (BAX 855) (EMEA-001296-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/506548/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-granting-deferral-pegylated-human-recombinant-factor-viii-bax-855-emea-001296-pip01-12_en.pdf"},
    {"id":"15061","name":"P/0172/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for clonidine (hydrochloride) (EMEA-001316-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/507523/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-clonidine-hydrochloride-emea-001316-pip01-12-m01_en.pdf"},
    {"id":"15062","name":"P/131/2008: European Medicines Agency decision of 19 December 2008 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for corifollitropin alfa (EMEA-0003...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/679022/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-131-2008-european-medicines-agency-decision-19-december-2008-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-corifollitropin-alfa-emea-0003_en.pdf"},
    {"id":"15063","name":"P/276/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for allergen extract of equal parts of lolium perenne, ph...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-11T01:00:00Z","last_updated_date":"2011-01-11T01:00:00Z","reference_number":"EMA/754260/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-276-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-allergen-extract-equal-parts-lolium-perenne-ph_en.pdf"},
    {"id":"15066","name":"P/0065/2012: EMA decision of 28 March 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for nitisinone (Orfadin) (EMEA-000784-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T16:00:00Z","last_updated_date":"2012-07-23T16:00:00Z","reference_number":"EMA/202042/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0065-2012-ema-decision-28-march-2012-agreement-paediatric-investigation-plan-granting-deferral-nitisinone-orfadin-emea-000784-pip02-11_en.pdf"},
    {"id":"15112","name":"P/0032/2015: EMA decision of 16 February 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emtricitabine / propan-2-yl N-[(S)-({[(2R)-1-(6-amin...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/49377/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2015-ema-decision-16-february-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-emtricitabine-propan-2-yl-n-s-2r-1-6-amin_en.pdf"},
    {"id":"15115","name":"P/8/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Rosiglitazone Maleate EMEA-000074-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europea...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-01-15T01:00:00Z","last_updated_date":"2008-01-15T01:00:00Z","reference_number":"EMEA/43606/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-8-2008-european-medicines-agency-decision-1-february-2008-application-product-specific-waiver-rosiglitazone-maleate-emea-000074-pip01-07-accordance-regulation-ec-no-1901-2006-europea_en.pdf"},
    {"id":"15142","name":"P/0343/2014: EMA decision of 22 December 2014 on the refusal of a paediatric investigation plan and on the refusal of a waiver for glycopyrronium bromide (EMEA-001591-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/624773/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0343-2014-ema-decision-22-december-2014-refusal-paediatric-investigation-plan-refusal-waiver-glycopyrronium-bromide-emea-001591-pip01-14_en.pdf"},
    {"id":"15155","name":"P/0140/2013: EMA decision of 3 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid\n\n(Aclasta), (EMEA-000057-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/331252/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2013-ema-decision-3-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-zoledronic-acid-aclasta-emea-000057-pip01-07-m05_en.pdf"},
    {"id":"15165","name":"P/0076/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (EMEA-001652-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/138341/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-cariprazine-hydrochloride-emea-001652-pip01-14-m01_en.pdf"},
    {"id":"15180","name":"P/61/2009: European Medicines Agency decision of 27 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for sitagliptin phosphate monohydrate (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/174941/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-61-2009-european-medicines-agency-decision-27-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sitagliptin-phosphate-monohydrate_en.pdf"},
    {"id":"15183","name":"P/0022/2013: EMA decision of 25 February 2013 on the granting of a product specific waiver for strontium (succinate) (Protelos, Osseor), (EMEA-000733-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/51547/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2013-ema-decision-25-february-2013-granting-product-specific-waiver-strontium-succinate-protelos-osseor-emea-000733-pip02-12_en.pdf"},
    {"id":"15184","name":"P/0262/2014: EMA decision of 3 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for eltrombopag (olamine) (Revolade), (EMEA-000170-PIP03-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/508736/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0262-2014-ema-decision-3-october-2014-agreement-paediatric-investigation-plan-granting-deferral-eltrombopag-olamine-revolade-emea-000170-pip03-13_en.pdf"},
    {"id":"15195","name":"P/0086/2012: EMA decision of 25 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ferumoxytol (EMEA-000373-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/339708/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0086-2012-ema-decision-25-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-ferumoxytol-emea-000373-pip02-09-m02_en.pdf"},
    {"id":"15208","name":"P/0306/2014: EMA decision of 24 November 2014 on the granting of a product specific waiver for purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomaviru...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/643705/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0306-2014-ema-decision-24-november-2014-granting-product-specific-waiver-purified-adenylate-cyclase-recombinant-protein-carrying-subfragments-early-protein-e7-antigen-human-papillomaviru_en.pdf"},
    {"id":"15250","name":"P/0090/2012: EMA decision of 29 May 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ixekizumab (EMEA-001050-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/331564/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2012-ema-decision-29-may-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ixekizumab-emea-001050-pip01-10_en.pdf"},
    {"id":"15256","name":"P/0030/2012: EMA decision of 2 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine\n\n(hydrochloride) (000317-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/54350/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2012-ema-decision-2-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-000317-pip01-08-m03_en.pdf"},
    {"id":"15257","name":"P/0226/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for nonacog beta pegol, (EMEA-000731-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-21T01:00:00Z","last_updated_date":"2013-11-21T01:00:00Z","reference_number":"EMA/562274/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2013-ema-decision-23-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-nonacog-beta-pegol-emea-000731-pip01-09-m01_en.pdf"},
    {"id":"15261","name":"P/38/2012: EMA decision of 24 February 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for modified Vaccinia Ankara - Bavarian Nordic virus (smallpox), (EMEA-001161-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/107989/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-38-2012-ema-decision-24-february-2012-agreement-paediatric-investigation-plan-granting-deferral-modified-vaccinia-ankara-bavarian-nordic-virus-smallpox-emea-001161-pip02-11_en.pdf"},
    {"id":"15301","name":"P/0140/2012: EMA decision of 20 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for potassium (chloride) / magnesium (sulphate heptahydrate) / procaine (hydrochloride) / xy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T17:15:00Z","last_updated_date":"2012-08-22T17:15:00Z","reference_number":"EMA/458510/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2012-ema-decision-20-july-2012-agreement-paediatric-investigation-plan-granting-deferral-potassium-chloride-magnesium-sulphate-heptahydrate-procaine-hydrochloride-xy_en.pdf"},
    {"id":"15327","name":"P/0189/2014: EMA decision of 6 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant single chain coagulation factor VIII (EMEA-001215-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/447572/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2014-ema-decision-6-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-single-chain-coagulation-factor-viii-emea-001215-pip01-11-m01_en.pdf"},
    {"id":"15346","name":"P/0217/2014: EMA decision of 3 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for apremilast (EMEA-000715-PIP05-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/468813/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2014-ema-decision-3-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-apremilast-emea-000715-pip05-13_en.pdf"},
    {"id":"15352","name":"P/0113/2014: EMA decision of 5 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for Live, attenuated, chimeric dengue virus, serotype 1 / Live,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/169096/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2014-ema-decision-5-may-2014-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-live-attenuated-chimeric-dengue-virus-serotype-1-live_en.pdf"},
    {"id":"15383","name":"P/0242/2012: EMA decision of 22 October 2012 on the granting of a product specific waiver for fostamatinib (EMEA-001196-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/624726/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2012-ema-decision-22-october-2012-granting-product-specific-waiver-fostamatinib-emea-001196-pip01-11_en.pdf"},
    {"id":"15402","name":"P/0107/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for (3aR,4S,7aR)-octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid methy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203225/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0107-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-3ar4s7ar-octahydro-4-hydroxy-4-3-methylphenylethynyl-1h-indole-1-carboxylic-acid-methy_en.pdf"},
    {"id":"15418","name":"P/0333/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for pilocarpine (hydrochloride) / oxymetazoline\n\n(hydrochloride) (EMEA-002181-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/661912/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0333-2017-ema-decision-31-october-2017-granting-product-specific-waiver-pilocarpine-hydrochloride-oxymetazoline-hydrochloride-emea-002181-pip01-17_en.pdf"},
    {"id":"15422","name":"P/0185/2015: EMA decision of 24 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (EMEA-001582-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/551845/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2015-ema-decision-24-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-lumacaftor-ivacaftor-emea-001582-pip01-13-m03_en.pdf"},
    {"id":"15451","name":"P/0144/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for rubidium (82Rb) chloride (Ruby-Fill (82Sr/82Rb Generator)), (EMEA-000882-PIP03-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/293459/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0144-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-rubidium-82rb-chloride-ruby-fill-82sr-82rb-generator-emea-000882-pip03-11-m03_en.pdf"},
    {"id":"15480","name":"P/0020/2018: EMA decision of 30 January 2018 on the refusal of a modification of an agreed paediatric investigation plan for gadolinium, [α3,α6,α9-\n\ntris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/28287/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2018-ema-decision-30-january-2018-refusal-modification-agreed-paediatric-investigation-plan-gadolinium-i-3i-6i-9-tris3-23-dihydroxypropylamino-3-oxopropyl-36915-tetraazabi_en.pdf"},
    {"id":"15481","name":"P/0082/2013: EMA decision of 27 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 1-(2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-fur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/192018/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0082-2013-ema-decision-27-march-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-1-2r5r-5-ethynyl-5-hydroxymethyl-25-dihydro-2-fur_en.pdf"},
    {"id":"15493","name":"P/0076/2012: EMA decision of 25 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (EMEA-\n\n000916-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/247588/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2012-ema-decision-25-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-lixisenatide-emea-000916-pip01-10-m02_en.pdf"},
    {"id":"15516","name":"P/0276/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Alnus glutinosa, Betula verrucosa and Corylus avellana (EMEA-000849-PIP01-10-M0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/766592/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0276-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-pollen-alnus-glutinosa-betula-verrucosa-corylus-avellana-emea-000849-pip01-10-m0_en.pdf"},
    {"id":"15531","name":"P/0016/2013: EMA decision of 25 January 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for dobutamine (hydrochloride) (EMEA-001262-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T14:30:00Z","last_updated_date":"2013-04-03T14:30:00Z","reference_number":"EMA/22299/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2013-ema-decision-25-january-2013-agreement-paediatric-investigation-plan-granting-waiver-dobutamine-hydrochloride-emea-001262-pip01-12_en.pdf"},
    {"id":"15545","name":"P/0105/2017: EMA decision of 11 April 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for macimorelin (EMEA-001988-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/166791/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2017-ema-decision-11-april-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-macimorelin-emea-001988-pip01-16_en.pdf"},
    {"id":"15556","name":"P/112/2012: EMA decision of 22 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for voriconazole (Vfend), (EMEA-000191-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/409344/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-112-2012-ema-decision-22-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-voriconazole-vfend-emea-000191-pip01-08-m04_en.pdf"},
    {"id":"15578","name":"P/201/2010: European Medicines Agency decision of 27 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for anidulafungin (Ecalta), (EMEA-000469-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/647157/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-201-2010-european-medicines-agency-decision-27-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-anidulafungin-ecalta-emea-000469-pip01-08-m01_en.pdf"},
    {"id":"15606","name":"P/208/2009: European Medicines Agency decision of 30 October 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for skimmed cow's milk powder (EMEA-000201-PIP01-08-M01) in accordance with...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/615805/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-208-2009-european-medicines-agency-decision-30-october-2009-acceptance-modification-agreed-paediatric-investigation-plan-skimmed-cows-milk-powder-emea-000201-pip01-08-m01-accordance_en.pdf"},
    {"id":"15636","name":"P/0157/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for momelotinib (EMEA-001656-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/424132/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-waiver-momelotinib-emea-001656-pip01-14_en.pdf"},
    {"id":"15643","name":"P/300/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for belimumab\n\n(Benlysta), (EMEA-000520-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/925807/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-300-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-belimumab-benlysta-emea-000520-pip01-08-m01_en.pdf"},
    {"id":"15656","name":"P/0115/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-\n\nmethyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complex...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T02:00:00Z","last_updated_date":"2018-07-25T02:00:00Z","reference_number":"EMA/194478/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0115-2018-ema-decision-11-april-2018-granting-product-specific-waiver-calcium-nn-12-ethanediylbisn-3-hydroxy-2-methyl-5-phosphonooxymethyl-4-pyridinylmethylglycine-manganese-complex_en.pdf"},
    {"id":"15665","name":"P/02/2009: European Medicines Agency decision of 27 January 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for recombinant L-asparaginase (EMEA-000013-PIP01-07-M01) in accordance with...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/29650/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-02-2009-european-medicines-agency-decision-27-january-2009-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-l-asparaginase-emea-000013-pip01-07-m01-accordance_en.pdf"},
    {"id":"15689","name":"P/99/2011: EMA decision of 14 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aripiprazole (Abilify) (EMEA-000235-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-13T02:00:00Z","last_updated_date":"2011-05-13T02:00:00Z","reference_number":"EMA/247887/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-99-2011-ema-decision-14-april-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aripiprazole-abilify-emea-000235-pip02-10_en.pdf"},
    {"id":"15699","name":"P/0082/2012: EMA decision of 3 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for purified tetanus toxoid / inactivated type 1 poliovirus (Mahoney) / inactivated type 2 poliovirus...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/272836/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0082-2012-ema-decision-3-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-purified-tetanus-toxoid-inactivated-type-1-poliovirus-mahoney-inactivated-type-2-poliovirus_en.pdf"},
    {"id":"15700","name":"P/0194/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for retosiban (EMEA-001359-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/505298/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-retosiban-emea-001359-pip01-12-m02_en.pdf"},
    {"id":"15702","name":"P/108/2009: European Medicines Agency decision of 9 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for carisbamate (EMEA-000360-PIP01-08) i...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/348643/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-108-2009-european-medicines-agency-decision-9-june-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-carisbamate-emea-000360-pip01-08-i_en.pdf"},
    {"id":"15710","name":"P/35/2011: EMA decision of 28 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ozenoxacin (EMA-000981-PIP01-10) in accordance with Reg...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-24T01:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/35658/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-35-2011-ema-decision-28-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ozenoxacin-ema-000981-pip01-10-accordance-reg_en.pdf"},
    {"id":"15731","name":"P/0212/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for budesonide (EMEA-\n\n001087-PIP02-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/441052/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-budesonide-emea-001087-pip02-12-m02_en.pdf"},
    {"id":"15753","name":"P/0284/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP02-09-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T12:37:00Z","last_updated_date":"2017-01-23T12:37:00Z","reference_number":"EMA/704430/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0284-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip02-09-m03_en.pdf"},
    {"id":"15760","name":"P/0139/2013: EMA decision of 24 June 2013 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (EMEA-000715-PIP03-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/332686/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2013-ema-decision-24-june-2013-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-emea-000715-pip03-11-m01_en.pdf"},
    {"id":"15781","name":"P/0020/2012: EMA decision of 27 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (Brilique, Possia) (EMEA-000480-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/44693/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2012-ema-decision-27-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-brilique-possia-emea-000480-pip01-08-m03_en.pdf"},
    {"id":"15818","name":"P/0289/2014: EMA decision of 24 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for human fibrinogen / human thrombin (EMEA-001598-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-04T01:00:00Z","last_updated_date":"2014-12-04T01:00:00Z","reference_number":"EMA/637703/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0289-2014-ema-decision-24-october-2014-agreement-paediatric-investigation-plan-granting-deferral-human-fibrinogen-human-thrombin-emea-001598-pip01-13_en.pdf"},
    {"id":"15841","name":"P/0222/2017: EMA decision of 9 August 2017 on the granting of a product-specific waiver for osimertinib (as mesylate) (Tagrisso), (EMEA-002125-\n\nPIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/431229/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2017-ema-decision-9-august-2017-granting-product-specific-waiver-osimertinib-mesylate-tagrisso-emea-002125-pip01-17_en.pdf"},
    {"id":"15847","name":"P/0132/2017: EMA decision of 7 June 2017 on the granting of a product specific waiver for nimodipine (EMEA-002097-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/306123/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2017-ema-decision-7-june-2017-granting-product-specific-waiver-nimodipine-emea-002097-pip01-16_en.pdf"},
    {"id":"15864","name":"P/0031/2014: European Medicines Agency decision of 21 February 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for azacitidine (Vidaza) (EMEA-001...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-03-20T01:00:00Z","last_updated_date":"2014-03-20T01:00:00Z","reference_number":"EMA/50728/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0031-2014-european-medicines-agency-decision-21-february-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-azacitidine-vidaza-emea-001_en.pdf"},
    {"id":"15876","name":"P/0120/2016: EMA decision of 28 April 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for solithromycin (EMEA-001581-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/266752/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2016-ema-decision-28-april-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-solithromycin-emea-001581-pip02-16_en.pdf"},
    {"id":"15880","name":"P/0172/2012: EMA decision of 27 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (EMEA-000872-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/489362/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2012-ema-decision-27-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000872-pip01-10-m01_en.pdf"},
    {"id":"15882","name":"P/0306/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for delamanid (Deltyba) (EMEA-001113-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/792872/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0306-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-delamanid-deltyba-emea-001113-pip01-10-m04_en.pdf"},
    {"id":"15893","name":"P/215/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for ulipristal acetate (EMEA-000629-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/687582/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-215-2009-european-medicines-agency-decision-30-october-2009-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-ulipristal-acetate-emea-000629-pip_en.pdf"},
    {"id":"15939","name":"P/91/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for propane-1-\n\nsulfonic acid {3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/193393/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-91-2011-ema-decision-8-april-2011-agreement-paediatric-investigation-plan-granting-deferral-propane-1-sulfonic-acid-3-5-4-chlorophenyl-1h-pyrrolo23-bpyridine-3-carbonyl-24_en.pdf"},
    {"id":"15941","name":"P/0118/2017: EMA decision of 5 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for 3-[[5-chloro-1-[3-\n\n(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-di...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/244252/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0118-2017-ema-decision-5-may-2017-acceptance-modification-agreed-paediatric-investigation-plan-3-5-chloro-1-3-methylsulfonylpropyl-1h-indol-2-ylmethyl-1-222-trifluoroethyl-13-di_en.pdf"},
    {"id":"15967","name":"P/0272/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/690865/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0272-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-pollen-dactylis-glomerata-lolium-perenne-phleum-pratense-festuca-pratensis-secale_en.pdf"},
    {"id":"15972","name":"P/110/2009: EMEA decision of 16 June 2009 on the agreement of a PIP and on the granting of a waiver for Human Papillomavirus type 6 L1 protein / Human Papillomavirus type 11 L1 protein / Human Papillomavirus type 16 L1 p...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-17T02:09:21Z","last_updated_date":"2009-06-17T02:09:21Z","reference_number":"EMEA/351400/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-110-2009-emea-decision-16-june-2009-agreement-pip-granting-waiver-human-papillomavirus-type-6-l1-protein-human-papillomavirus-type-11-l1-protein-human-papillomavirus-type-16-l1-p_en.pdf"},
    {"id":"15979","name":"P/308/2011: EMA decision of 20 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for chimeric monoclonal anti-Shiga toxin (Stx) antibodies ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/954001/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-308-2011-ema-decision-20-december-2011-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-chimeric-monoclonal-anti-shiga-toxin-stx-antibodies_en.pdf"},
    {"id":"15980","name":"P/0152/2013: EMA decision of 5 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation factor VIII / von Willebrand factor (EMEA-000312-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/339828/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2013-ema-decision-5-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-emea-000312-pip01-08-m05_en.pdf"},
    {"id":"16005","name":"P/0263/2015: EMA decision of 30 October 2015 on the refusal of a modification of an agreed paediatric investigation plan for rufinamide (Inovelon) (EMEA-000709-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/702366/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0263-2015-ema-decision-30-october-2015-refusal-modification-agreed-paediatric-investigation-plan-rufinamide-inovelon-emea-000709-pip01-09-m03_en.pdf"},
    {"id":"16013","name":"P/0077/2013: EMA decision of 26 March 2013 on the granting of a product-specific waiver for bisoprolol / amlodipine (EMEA-001385-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/85726/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2013-ema-decision-26-march-2013-granting-product-specific-waiver-bisoprolol-amlodipine-emea-001385-pip01-12_en.pdf"},
    {"id":"16024","name":"P/0049/2012: EMA decision of 1 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / triphenylacetic acid - 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}h...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-10T02:00:00Z","last_updated_date":"2012-04-10T02:00:00Z","reference_number":"EMA/354564/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2012-ema-decision-1-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-triphenylacetic-acid-4-1r-2-6-2-26-dichlorobenzyloxyethoxyh_en.pdf"},
    {"id":"16028","name":"P/0193/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for 1-(2,2-difluoro-1,3-\n\nbenzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydrox...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:19:00Z","last_updated_date":"2016-09-22T16:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-1-22-difluoro-13-benzodioxol-5-yl-n-1-2r-23-dihydroxypropyl-6-fluoro-2-1-hydrox_en.pdf"},
    {"id":"16056","name":"P/0118/2013: EMA decision of 2 May 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel), (EMEA-000567-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-21T13:10:00Z","last_updated_date":"2013-06-21T13:10:00Z","reference_number":"EMA/242689/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0118-2013-ema-decision-2-may-2013-acceptance-modification-agreed-paediatric-investigation-plan-dasatinib-sprycel-emea-000567-pip01-09-m04_en.pdf"},
    {"id":"16063","name":"P/254/2010:  EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aluminium hydroxide adsorbed, depigmented glutaralde...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/710352/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-254-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaralde_en.pdf"},
    {"id":"16075","name":"P/151/2011: EMA decision of 10 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (EMEA-000117-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-13T02:00:00Z","last_updated_date":"2011-07-13T02:00:00Z","reference_number":"EMA/440862/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-151-2011-ema-decision-10-june-2011-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-emea-000117-pip01-07-m02_en.pdf"},
    {"id":"16085","name":"P/0005/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins (Xeomin, Bocou...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/864531/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-clostridium-botulinum-neurotoxin-type-150-kd-free-complexing-proteins-xeomin-bocou_en.pdf"},
    {"id":"16089","name":"P/0297/2013: EMA decision of 29 November 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for alirocumab (EMEA-001169-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/647587/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0297-2013-ema-decision-29-november-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-alirocumab-emea-001169-pip01-11_en.pdf"},
    {"id":"16092","name":"P/6/2011:  EMA decision of 3 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for midostaurin, (EMEA-000780-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/716713/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-6-2011-ema-decision-3-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-midostaurin-emea-000780-pip01-09_en.pdf"},
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    {"id":"16214","name":"P/111/2012: EMA decision of 29 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for asenapine (maleate) (Sycrest) (EMEA-000228-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/332277/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-111-2012-ema-decision-29-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-asenapine-maleate-sycrest-emea-000228-pip01-08-m03_en.pdf"},
    {"id":"16217","name":"P/0048/2017: EMA decision of 23 February 2017 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam\n\n(Briviact), (EMEA-000332-PIP01-08-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-18T02:00:00Z","last_updated_date":"2017-04-18T02:00:00Z","reference_number":"EMA/105851/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0048-2017-ema-decision-23-february-2017-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-briviact-emea-000332-pip01-08-m11_en.pdf"},
    {"id":"16219","name":"P/0209/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal\n\npolysaccharide serotype 6B conjugated to protein D ... (EMEA-000673-PIP01-09-M0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/520305/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-pneumococcal-polysaccharide-serotype-6b-conjugated-protein-d-emea-000673-pip01-09-m0_en.pdf"},
    {"id":"16223","name":"P/224/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eculizumab (Soliris), (EMEA-0008...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/629630/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-224-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eculizumab-soliris-emea-0008_en.pdf"},
    {"id":"16228","name":"P/0153/2013: EMA decision of 5 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for cysteamine hydrochloride (EMEA-000322-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/339827/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2013-ema-decision-5-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-cysteamine-hydrochloride-emea-000322-pip01-08-m02_en.pdf"},
    {"id":"16269","name":"P/44/2009: European Medicines Agency decision of 23 March 2009 on the refusal of a product specific waiver for dexamethasone (EMEA-000198-PIP02-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliame...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/155675/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-44-2009-european-medicines-agency-decision-23-march-2009-refusal-product-specific-waiver-dexamethasone-emea-000198-pip02-08-accordance-regulation-ec-no-1901-2006-european-parliame_en.pdf"},
    {"id":"16307","name":"P/0089/2017: EMA decision of 6 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for melatonin (Circadin), (EMEA-000440-PIP02-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/208387/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2017-ema-decision-6-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-melatonin-circadin-emea-000440-pip02-11-m05_en.pdf"},
    {"id":"16323","name":"P/0005/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for bevacizumab (Avastin), (EMEA-000056-PIP03-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/738885/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-bevacizumab-avastin-emea-000056-pip03-10-m02_en.pdf"},
    {"id":"16345","name":"P/0140/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/312701/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-enalapril-maleate-emea-001706-pip01-14-m01_en.pdf"},
    {"id":"16359","name":"P/0277/2014: EMA decision of 28 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for rufinamide (Inovelon), (EMEA-000709-PIP01-09-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/605297/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0277-2014-ema-decision-28-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-rufinamide-inovelon-emea-000709-pip01-09-m02_en.pdf"},
    {"id":"16368","name":"P/37/2008: European medicines agency decision of 24 June 2008\n\non the application for agreement of a Paediatric Investigation Plan for pitavastatin calcium EMEA-000301-PIP01-08 in accordance with Regulation (EC) No 1901/...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-06-24T03:00:00Z","last_updated_date":"2008-06-24T03:00:00Z","reference_number":"EMEA/315967/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-37-2008-european-medicines-agency-decision-24-june-2008-application-agreement-paediatric-investigation-plan-pitavastatin-calcium-emea-000301-pip01-08-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"16371","name":"P/0075/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for naloxone (hydrochloride) (EMEA-001567-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/131048/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-naloxone-hydrochloride-emea-001567-pip01-13-m02_en.pdf"},
    {"id":"16375","name":"P/120/2008: European Medicines Agency decision of 1 December 2008 on the application for product specific waiver for omega-3-acid (85% ethyl esters of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in a ratio...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/624450/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-120-2008-european-medicines-agency-decision-1-december-2008-application-product-specific-waiver-omega-3-acid-85-ethyl-esters-eicosapentaenoic-acid-epa-docosahexaenoic-acid-dha-ratio_en.pdf"},
    {"id":"16387","name":"P/0131/2015: EMA decision of 12 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira), (EMEA-000366-PIP02-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-07T02:00:00Z","last_updated_date":"2015-07-07T02:00:00Z","reference_number":"EMA/368695/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2015-ema-decision-12-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip02-09-m04_en.pdf"},
    {"id":"16399","name":"P/150/2010: EMA decision of 6 August 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for tenofovir disoproxil fumarate/emtricitabine/rilpivirine h...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/488816/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-150-2010-ema-decision-6-august-2010-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-tenofovir-disoproxil-fumarate-emtricitabine-rilpivirine-h_en.pdf"},
    {"id":"16401","name":"P/0079/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan for arimoclomol (citrate) (EMEA-001748-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/104860/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-arimoclomol-citrate-emea-001748-pip01-15_en.pdf"},
    {"id":"16402","name":"P/0129/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP02-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T02:00:00Z","last_updated_date":"2018-07-25T02:00:00Z","reference_number":"EMA/201260/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-guselkumab-tremfya-emea-001523-pip02-14-m02_en.pdf"},
    {"id":"16408","name":"P/0130/2012: EMA decision of 4 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for albiglutide (EMEA-001175-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/411120/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2012-ema-decision-4-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-albiglutide-emea-001175-pip01-11_en.pdf"},
    {"id":"16422","name":"P/0280/2014: EMA decision of 30 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for fibrinogen / thrombin / aprotinin / calcium chloride (EMEA-001079-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-09T01:00:00Z","last_updated_date":"2014-12-09T01:00:00Z","reference_number":"EMA/587540/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0280-2014-ema-decision-30-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-fibrinogen-thrombin-aprotinin-calcium-chloride-emea-001079-pip01-10-m02_en.pdf"},
    {"id":"16427","name":"P/0279/2016: EMA decision of 7 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for Eteplirsen (EMEA-\n\n001722-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/643929/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0279-2016-ema-decision-7-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-eteplirsen-emea-001722-pip01-14-m01_en.pdf"},
    {"id":"16433","name":"P/0186/2015: EMA decision of 27 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (HyQvia) (EMEA-000872-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/556402/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2015-ema-decision-27-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-hyqvia-emea-000872-pip01-10-m03_en.pdf"},
    {"id":"16441","name":"P/209/2011: EMA decision of 30 August 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for teriflunomide (EMEA-001094-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/643565/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-209-2011-ema-decision-30-august-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-teriflunomide-emea-001094-pip01-10_en.pdf"},
    {"id":"16445","name":"P/0250/2016: EMA decision of 9 September 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for bivalent anti-human myostatin adnectin recombinant ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/585777/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2016-ema-decision-9-september-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bivalent-anti-human-myostatin-adnectin-recombinant_en.pdf"},
    {"id":"16450","name":"P/0261/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lipegfilgrastim\n\n(Lonquex), (EMEA-001019-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T17:00:00Z","last_updated_date":"2017-10-25T17:00:00Z","reference_number":"EMA/493094/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0261-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-lipegfilgrastim-lonquex-emea-001019-pip01-10-m04_en.pdf"},
    {"id":"16455","name":"P/0259/2014: EMA decision of 1 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for D-argininamide, N-acetyl-D-cysteinyl-D-alanyl-D-arginy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/514793/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2014-ema-decision-1-october-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-d-argininamide-n-acetyl-d-cysteinyl-d-alanyl-d-arginy_en.pdf"},
    {"id":"16485","name":"P/0080/2017: EMA decision of 17 March 2017 on the refusal of a paediatric investigation plan and on the granting of a waiver for methylphenidate\n\n(hydrochloride) (EMEA-002034-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/137024/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2017-ema-decision-17-march-2017-refusal-paediatric-investigation-plan-granting-waiver-methylphenidate-hydrochloride-emea-002034-pip01-16_en.pdf"},
    {"id":"16491","name":"P/0236/2014: EMA decision of 19 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tap...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-10-09T02:00:00Z","last_updated_date":"2014-10-09T02:00:00Z","reference_number":"EMA/547327/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2014-ema-decision-19-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tap_en.pdf"},
    {"id":"16515","name":"P/142/2009: EMA decision of 30 July 2010 on the refusal of a modification of an agreed paediatric investigation plan for tapentadol hydrochloride (EMEA-000494-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-09-09T02:00:00Z","last_updated_date":"2010-09-09T02:00:00Z","reference_number":"EMA/469400/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-142-2009-ema-decision-30-july-2010-refusal-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-emea-000494-pip01-08-m02_en.pdf"},
    {"id":"16517","name":"P/89/2010: European Medicines Agency decision of 1 June 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for solifenacin succinate (Vesicare and associated names) (EMEA-000573-PIP0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/337481/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-89-2010-european-medicines-agency-decision-1-june-2010-agreement-paediatric-investigation-plan-granting-waiver-solifenacin-succinate-vesicare-associated-names-emea-000573-pip0_en.pdf"},
    {"id":"16522","name":"P/64/2011: EMA decision of 10 March 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abatacept (Orencia) (EMEA-000118-PIP02-10) in accordance ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/170436/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-64-2011-ema-decision-10-march-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-abatacept-orencia-emea-000118-pip02-10-accordance_en.pdf"},
    {"id":"16549","name":"P/0108/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (EMEA-001030-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/206799/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0108-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-emea-001030-pip01-10-m01_en.pdf"},
    {"id":"16556","name":"P/0011/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for ixekizumab (Taltz),\n\n(EMEA-001050-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/28229/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-ixekizumab-taltz-emea-001050-pip01-10-m03_en.pdf"},
    {"id":"16606","name":"P/275/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for allergen extract of betula verrucosa pollen (EMEA-000...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-11T01:00:00Z","last_updated_date":"2011-01-11T01:00:00Z","reference_number":"EMA/683371/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-275-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-allergen-extract-betula-verrucosa-pollen-emea-000_en.pdf"},
    {"id":"16654","name":"P/0044/2014: EMA decision of 7 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet hydrochloride (Mimpara) (EMEA-000078-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/58492/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2014-ema-decision-7-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-cinacalcet-hydrochloride-mimpara-emea-000078-pip01-07-m04_en.pdf"},
    {"id":"16727","name":"P/0370/2016: European Medicines Agency decision of 4 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-(human calcitonin gene-rela...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/4029/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0370-2016-european-medicines-agency-decision-4-january-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-human-calcitonin-gene-rela_en.pdf"},
    {"id":"16737","name":"P/0291/2015: EMA decision of 27 November 2015 on the refusal of a paediatric investigation plan and on the granting of a waiver for recombinant human growth hormone fused to hybrid Fc composed of the hinge region and N-t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/690013/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0291-2015-ema-decision-27-november-2015-refusal-paediatric-investigation-plan-granting-waiver-recombinant-human-growth-hormone-fused-hybrid-fc-composed-hinge-region-n-t_en.pdf"},
    {"id":"16742","name":"P/204/2010: European Medicines Agency decision of 27 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Birch, Hazel and Alder Pollen Ex...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/647417/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-204-2010-european-medicines-agency-decision-27-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-birch-hazel-alder-pollen-ex_en.pdf"},
    {"id":"16743","name":"P/0121/2014: EMA decision of 7 May 2014 on the granting of a product specific waiver for amlodipine / rosuvastatin (EMEA-001578-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/195552/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2014-ema-decision-7-may-2014-granting-product-specific-waiver-amlodipine-rosuvastatin-emea-001578-pip01-13_en.pdf"},
    {"id":"16747","name":"P/304/2011: EMA decision of 20 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for recombinant human granulocyte colony stimulating facto...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/953999/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-304-2011-ema-decision-20-december-2011-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-recombinant-human-granulocyte-colony-stimulating-facto_en.pdf"},
    {"id":"16772","name":"P/0059/2014: European Medicines Agency decision of 7 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-PD1 humanized monoclonal anti...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/52884/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2014-european-medicines-agency-decision-7-march-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-pd1-humanized-monoclonal-anti_en.pdf"},
    {"id":"16775","name":"P/188/2010: European Medicines Agency decision of 24 September 2010 on the granting of a product specific waiver for amlodipine camsylate / losartan potassium (EMEA-000886-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/596152/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-188-2010-european-medicines-agency-decision-24-september-2010-granting-product-specific-waiver-amlodipine-camsylate-losartan-potassium-emea-000886-pip01-10_en.pdf"},
    {"id":"16779","name":"P/0001/2017: EMA decision of 5 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone(dipropionate) / formoterol (fumarate dihydrate) (Foster and associated names, K...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/3349/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2017-ema-decision-5-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-beclometasonedipropionate-formoterol-fumarate-dihydrate-foster-associated-names-k_en.pdf"},
    {"id":"16786","name":"P/0215/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dinutuximab\n\n(Unituxin) (EMEA-001285-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/472143/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-dinutuximab-unituxin-emea-001285-pip01-12-m02_en.pdf"},
    {"id":"16796","name":"P/0283/2014: EMA decision of 30 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for landiolol (hydrochloride) (EMEA-001150-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-04T01:00:00Z","last_updated_date":"2014-12-04T01:00:00Z","reference_number":"EMA/592453/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0283-2014-ema-decision-30-october-2014-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-landiolol-hydrochloride-emea-001150-pip02-13_en.pdf"},
    {"id":"16812","name":"P/319/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of birch, alder and hazel p...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769414/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-319-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-birch-alder-hazel-p_en.pdf"},
    {"id":"16819","name":"P/0161/2012: EMA decision of 20 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide serotype 1 – diphtheria CRM197 conjugate, pneumococcal polysacchari...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/474586/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2012-ema-decision-20-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-pneumococcal-polysaccharide-serotype-1-diphtheria-crm197-conjugate-pneumococcal-polysacchari_en.pdf"},
    {"id":"16849","name":"P/0026/2014: EMA decision of 24 January 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for elvitegravir / cobicistat / emtricitabine / tenofovir...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/774466/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2014-ema-decision-24-january-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-elvitegravir-cobicistat-emtricitabine-tenofovir_en.pdf"},
    {"id":"16878","name":"P/322/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for modified allergen extract of grass and birch pollen ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/683348/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-322-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-birch-pollen_en.pdf"},
    {"id":"16892","name":"P/0081/2014: EMA decision of 2 April 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (E)-4-[(5-Phenyl-1,3,4-thiadiazol-2-yl)oxy]-1-azoniatric...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2014-05-13T02:00:00Z","reference_number":"EMA/122563/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2014-ema-decision-2-april-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-e-4-5-phenyl-134-thiadiazol-2-yloxy-1-azoniatric_en.pdf"},
    {"id":"16905","name":"P/157/2009: European Medicines Agency decision of 11 August 2009 on the granting of a product specific waiver for 5-aminolevulinic acid, hydrochloride (EMEA-000521-PIP01-08) in accordance with Regulation (EC) No 1901/200...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/492758/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-157-2009-european-medicines-agency-decision-11-august-2009-granting-product-specific-waiver-5-aminolevulinic-acid-hydrochloride-emea-000521-pip01-08-accordance-regulation-ec-no-1901-200_en.pdf"},
    {"id":"16910","name":"P/0168/2014: EMA decision of 8 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin peglispro (EMEA-001097-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/349913/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2014-ema-decision-8-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-insulin-peglispro-emea-001097-pip01-10-m02_en.pdf"},
    {"id":"16914","name":"P/0076/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan for anti programmed death-ligand 1 (PD-L1) monoclonal antibody (MPDL3280A) (EMEA-001638-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/111608/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2015-ema-decision-1-april-2015-agreement-paediatric-investigation-plan-anti-programmed-death-ligand-1-pd-l1-monoclonal-antibody-mpdl3280a-emea-001638-pip01-14_en.pdf"},
    {"id":"16918","name":"P/219/2011: EMA decision of 26 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for mepolizumab (EMEA-000069-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/679385/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-219-2011-ema-decision-26-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mepolizumab-emea-000069-pip02-10_en.pdf"},
    {"id":"16920","name":"P/0141/2013: EMA decision of 3 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (Ilaris) (EMEA-000060-PIP02-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/331976/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2013-ema-decision-3-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-canakinumab-ilaris-emea-000060-pip02-08-m06_en.pdf"},
    {"id":"16927","name":"P/0009/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (Trobalt), (EMEA-000116-PIP01-07-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/23015/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-retigabine-trobalt-emea-000116-pip01-07-m08_en.pdf"},
    {"id":"16933","name":"P/0255/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant parathyroid hormone (EMEA-001526-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/619860/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0255-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-parathyroid-hormone-emea-001526-pip01-13-m01_en.pdf"},
    {"id":"16962","name":"P/0065/2014: European Medicines Agency decision of 10 March 2014 on the refusal of a paediatric investigation plan and on the granting of a waiver for recombinant human growth hormone modified by fusion with two hydrophi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/55121/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0065-2014-european-medicines-agency-decision-10-march-2014-refusal-paediatric-investigation-plan-granting-waiver-recombinant-human-growth-hormone-modified-fusion-two-hydrophi_en.pdf"},
    {"id":"16980","name":"P/230/2011: EMA decision of 28 September 2011 on the granting of a product specific waiver for progesterone (EMEA-001109-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/698094/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-230-2011-ema-decision-28-september-2011-granting-product-specific-waiver-progesterone-emea-001109-pip01-10_en.pdf"},
    {"id":"16988","name":"P/74/2011: EMA decision of 5 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for voriconazole (Vfend),\n\n(EMEA-000191-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/244232/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-74-2011-ema-decision-5-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-voriconazole-vfend-emea-000191-pip01-08-m02_en.pdf"},
    {"id":"17001","name":"P/0062/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/102949/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0062-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-ambrisentan-volibris-emea-000434-pip01-08-m01_en.pdf"},
    {"id":"17043","name":"P/0248/2017: EMA decision of 4 September 2017 on the granting of a product specific waiver for human normal immunoglobulin (EMEA-002092-PIP01-\n\n16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/506969/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0248-2017-ema-decision-4-september-2017-granting-product-specific-waiver-human-normal-immunoglobulin-emea-002092-pip01-16_en.pdf"},
    {"id":"17045","name":"P/313/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass and rye pollen (60...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769458/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-313-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-rye-pollen-60_en.pdf"},
    {"id":"17049","name":"P/0004/2018: EMA decision of 4 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for L-asparaginase\n\nencapsulated in erythrocytes, (EMEA-000341-PIP02-09-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T15:28:00Z","last_updated_date":"2018-04-17T15:28:00Z","reference_number":"EMA/993/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2018-ema-decision-4-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-l-asparaginase-encapsulated-erythrocytes-emea-000341-pip02-09-m05_en.pdf"},
    {"id":"17088","name":"P/243/2011: EMA decision of 30 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for lorcaserin (EMEA-001098-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/760982/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-243-2011-ema-decision-30-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lorcaserin-emea-001098-pip01-10_en.pdf"},
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    {"id":"17134","name":"P/0135/2013: EMA decision of 14 June 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for\n\nisavuconazonium (sulfate) (EMEA-001301-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/314990/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2013-ema-decision-14-june-2013-agreement-paediatric-investigation-plan-granting-deferral-isavuconazonium-sulfate-emea-001301-pip02-12_en.pdf"},
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    {"id":"17191","name":"P/239/2011: EMA decision of 30 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (Brilique, Possia) (EMEA-000480-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/766413/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-239-2011-ema-decision-30-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-brilique-possia-emea-000480-pip01-08-m02_en.pdf"},
    {"id":"17198","name":"P/262/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of Phleum pratense, Dactylis glomerata, Festu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/670697/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-262-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mixture-phleum-pratense-dactylis-glomerata-festu_en.pdf"},
    {"id":"17208","name":"P/0294/2012: EMA decision of 18 December 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (S)-isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T14:00:00Z","last_updated_date":"2013-02-08T14:00:00Z","reference_number":"EMA/802135/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2012-ema-decision-18-december-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-s-isopropyl-2-s-2r3r4r5r-5-24-dioxo-3_en.pdf"},
    {"id":"17236","name":"P/0316/2016: EMA decision of 2 December 2016\n\non the acceptance of a modification of an agreed paediatric investigation plan for cannabidiol / delta-9-tetrahydrocannabinol (Sativex), (EMEA-000181-PIP01-08-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T09:55:00Z","last_updated_date":"2017-01-30T09:55:00Z","reference_number":"EMA/741977/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0316-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-cannabidiol-delta-9-tetrahydrocannabinol-sativex-emea-000181-pip01-08-m03_en.pdf"},
    {"id":"17253","name":"P/0304/2014: EMA decision of 24 November 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for inotuzumab ozogamicin (EMEA-001429-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/641736/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2014-ema-decision-24-november-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-inotuzumab-ozogamicin-emea-001429-pip01-13_en.pdf"},
    {"id":"17275","name":"P/0150/2012: EMA decision of 16 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for turoctocog alpha (EMEA-000428-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/472343/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0150-2012-ema-decision-16-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-turoctocog-alpha-emea-000428-pip01-08-m01_en.pdf"},
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    {"id":"17279","name":"P/0071/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for encorafenib\n\n(EMEA-001588-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/75543/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-encorafenib-emea-001588-pip01-13-m01_en.pdf"},
    {"id":"17286","name":"P/0003/2012: EMA decision of 23 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of bi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/972923/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0003-2012-ema-decision-23-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-bi_en.pdf"},
    {"id":"17287","name":"P/199/2010: European Medicines Agency decision of 27 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for motavizumab (EMEA-000352-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/651476/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-199-2010-european-medicines-agency-decision-27-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-motavizumab-emea-000352-pip01-08-m01_en.pdf"},
    {"id":"17302","name":"P/0012/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (EDURANT) (EMEA-000317-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/4099/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m08_en.pdf"},
    {"id":"17312","name":"P/58/2011: EMA decision of 4 March 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for laquinimod (sodium) (EMEA-000972-PIP01-10) in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/155689/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-58-2011-ema-decision-4-march-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-laquinimod-sodium-emea-000972-pip01-10-accordance-w_en.pdf"},
    {"id":"17319","name":"P/0326/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin\n\n(Jardiance), (EMEA-000828-PIP01-09-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-31T11:35:00Z","last_updated_date":"2017-01-31T11:35:00Z","reference_number":"EMA/756830/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0326-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-empagliflozin-jardiance-emea-000828-pip01-09-m05_en.pdf"},
    {"id":"17336","name":"P/0111/2013: EMA decision of 30 April 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for palivizumab (Synagis) (EMEA-001309-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203434/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2013-ema-decision-30-april-2013-agreement-paediatric-investigation-plan-granting-waiver-palivizumab-synagis-emea-001309-pip01-12_en.pdf"},
    {"id":"17343","name":"P/0028/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin\n\n(Jardiance) (EMEA-000828-PIP01-09-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T11:41:00Z","last_updated_date":"2018-04-18T11:41:00Z","reference_number":"EMA/792965/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-empagliflozin-jardiance-emea-000828-pip01-09-m06_en.pdf"},
    {"id":"17372","name":"P/0312/2014: EMA decision of 26 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for lomitapide (Lojuxta), (EMEA-001124-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/667883/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0312-2014-ema-decision-26-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-lomitapide-lojuxta-emea-001124-pip01-10-m02_en.pdf"},
    {"id":"17381","name":"P/54/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Glucosamine hydrochloride,\n\nchondroitin sulphate, PIP number EMEA-000171-PIP01-07 in accordance with Regula...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-08T02:00:00Z","last_updated_date":"2008-09-08T02:00:00Z","reference_number":"EMEA/363689/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-54-2008-european-medicines-agency-decision-20-july-2008-application-product-specific-waiver-glucosamine-hydrochloride-chondroitin-sulphate-pip-number-emea-000171-pip01-07-accordance-regula_en.pdf"},
    {"id":"17384","name":"P/0121/2012: EMA decision of 3 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for lumacaftor (EMEA-001173-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/422871/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2012-ema-decision-3-july-2012-agreement-paediatric-investigation-plan-granting-deferral-lumacaftor-emea-001173-pip01-11_en.pdf"},
    {"id":"17386","name":"P/0150/2016: EMA decision of 14 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for irutinib (Imbruvica)\n\n(EMEA-001397-PIP03-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/380518/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0150-2016-ema-decision-14-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-irutinib-imbruvica-emea-001397-pip03-14-m01_en.pdf"},
    {"id":"17407","name":"P/0038/2016: EMA decision of 19 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rufinamide, (Inovelon) (EMEA-000709-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/95670/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0038-2016-ema-decision-19-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-rufinamide-inovelon-emea-000709-pip01-09-m04_en.pdf"},
    {"id":"17429","name":"P/63/2011: EMA decision of 18 February 2011 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab\n\n(Humira) (EMEA-000366-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2011-03-08T01:00:00Z","reference_number":"EMA/140284/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-63-2011-ema-decision-18-february-2011-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip02-09-m01_en.pdf"},
    {"id":"17441","name":"P/0143/2016: EMA decision of 20 May 2016 on the granting of a product specific waiver for hydrogen peroxide (EMEA-001884-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/249420/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2016-ema-decision-20-may-2016-granting-product-specific-waiver-hydrogen-peroxide-emea-001884-pip02-15_en.pdf"},
    {"id":"17444","name":"P/142/2011: EMA decision of 9 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chemically modified house dust mites allergen extract (der...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/417239/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-142-2011-ema-decision-9-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chemically-modified-house-dust-mites-allergen-extract-der_en.pdf"},
    {"id":"17456","name":"P/0282/2012: EMA decision of 23 November 2012 on the granting of a product-specific waiver for icatibant (Firazyr), (EMEA-000408-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-07T01:00:00Z","last_updated_date":"2013-01-07T01:00:00Z","reference_number":"EMA/739090/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0282-2012-ema-decision-23-november-2012-granting-product-specific-waiver-icatibant-firazyr-emea-000408-pip02-12_en.pdf"},
    {"id":"17457","name":"P/0282/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate\n\n(Pradaxa), (EMEA-000081-PIP01-07-M09)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T14:44:00Z","last_updated_date":"2017-01-23T14:44:00Z","reference_number":"EMA/640003/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0282-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-pradaxa-emea-000081-pip01-07-m09_en.pdf"},
    {"id":"17486","name":"P/267/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Vezepra and associated names) (EMEA-000301-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/831322/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-267-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-vezepra-associated-names-emea-000301-pip01-08-m02_en.pdf"},
    {"id":"17490","name":"P/35/2009: European Medicines Agency decision of 24 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for sunitinib malate (Sutent) (EMEA-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/94177/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-35-2009-european-medicines-agency-decision-24-february-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sunitinib-malate-sutent-emea_en.pdf"},
    {"id":"17492","name":"P/298/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (phosphate monohydrate) (Januvia), (EMEA-000470-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/943257/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-298-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-januvia-emea-000470-pip01-08-m05_en.pdf"},
    {"id":"17495","name":"P/162/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for perindopril erbumine / amlodipine besylate (EMEA-\n\n000983-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/476893/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-162-2010-ema-decision-27-august-2010-agreement-paediatric-investigation-plan-granting-product-specific-waiver-perindopril-erbumine-amlodipine-besylate-emea-000983-pip01-10_en.pdf"},
    {"id":"17504","name":"P/0179/2012: EMA decision of 20 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab (RoActemra) (EMEA-000309-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/477977/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2012-ema-decision-20-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-tocilizumab-roactemra-emea-000309-pip01-08-m04_en.pdf"},
    {"id":"17522","name":"P/252/2011: EMA decision of 26 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone propionate / formoterol fumarate, (EMEA-000127-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/829912/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-252-2011-ema-decision-26-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-propionate-formoterol-fumarate-emea-000127-pip01-07-m02_en.pdf"},
    {"id":"17567","name":"P/166/2009: European Medicines Agency decision of 21 August 2009 on the refusal of a Paediatric Investigation Plan for live bacterium B. thetaiotaomicron (EMEA-000561-PIP01-09) in accordance with Regulation (EC) No 1901/...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/494847/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-166-2009-european-medicines-agency-decision-21-august-2009-refusal-paediatric-investigation-plan-live-bacterium-b-thetaiotaomicron-emea-000561-pip01-09-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"17571","name":"P/0309/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir /\n\nemtricitabine / tenofovir disoproxil (as fumarate) / cobicistat (Stribild), ...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-19T11:00:00Z","last_updated_date":"2017-01-19T11:00:00Z","reference_number":"EMA/713477/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0309-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-emtricitabine-tenofovir-disoproxil-fumarate-cobicistat-stribild_en.pdf"},
    {"id":"17598","name":"P/112/2011: poly(oxy-1,2-ethanediyl),alpha-hydro-omega-methoxy-133 ester with granulocyte colony-stimulating factor [methionyl,133-[O-[2-(acetylamino]-6-O-[N-[Ncarboxyglycyl) amino]-alpha neuraminosyl]-2-deoxy-alpha-D-ga...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/334992/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-112-2011-polyoxy-12-ethanediylalpha-hydro-omega-methoxy-133-ester-granulocyte-colony-stimulating-factor-methionyl133-o-2-acetylamino-6-o-n-ncarboxyglycyl-amino-alpha-neuraminosyl-2-deoxy-alpha-d-ga_en.pdf"},
    {"id":"17634","name":"P/0180/2014: EMA decision of 17 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for daclatasvir (EMEA-001191-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/414728/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2014-ema-decision-17-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-daclatasvir-emea-001191-pip01-11-m01_en.pdf"},
    {"id":"17639","name":"P/0063/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for belimumab (Benlysta), (EMEA-000520-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/104070/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-belimumab-benlysta-emea-000520-pip01-08-m02_en.pdf"},
    {"id":"17659","name":"P/0007/2012: EMA decision of 24 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Xgeva\n\n(previously Amgiva)), (Prolia), (EMEA-000145-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/25162/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2012-ema-decision-24-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-xgeva-previously-amgiva-prolia-emea-000145-pip01-07-m04_en.pdf"},
    {"id":"17662","name":"P/206/2010: European Medicines Agency decision of 27 October 2010 on the granting of a product specific waiver for ingenol mebutate (EMEA-000894-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/649852/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-206-2010-european-medicines-agency-decision-27-october-2010-granting-product-specific-waiver-ingenol-mebutate-emea-000894-pip01-10_en.pdf"},
    {"id":"17684","name":"P/0018/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for obiltoxaximab (EMEA-002144-PIP01-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T02:00:00Z","last_updated_date":"2018-04-17T02:00:00Z","reference_number":"EMA/850790/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2018-ema-decision-30-january-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-obiltoxaximab-emea-002144-pip01-17_en.pdf"},
    {"id":"17704","name":"P/327/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of pollen from Phleum prate...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/697310/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-327-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-pollen-phleum-prate_en.pdf"},
    {"id":"17708","name":"P/0243/2014: EMA decision of 29 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for 7-[4-(4-Benzo[b]thiophen-4-ylpiperazin-1-yl)butoxy]quinolin-2(1H)-one (OPC-34712) (EMEA-00...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/508721/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2014-ema-decision-29-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-7-4-4-benzobthiophen-4-ylpiperazin-1-ylbutoxyquinolin-21h-one-opc-34712-emea-00_en.pdf"},
    {"id":"17719","name":"P/135/2009: European Medicines Agency decision of 15 July 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for N-[4-(3-amino-1H-indazol-4 yl)phenyl]-N1-(2-fluoro-5-methylphenyl) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/388509/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-135-2009-european-medicines-agency-decision-15-july-2009-agreement-paediatric-investigation-plan-granting-deferral-n-4-3-amino-1h-indazol-4-ylphenyl-n1-2-fluoro-5-methylphenyl_en.pdf"},
    {"id":"17746","name":"P/0258/2015: EMA decision of 30 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (3-((4-Benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T01:00:00Z","last_updated_date":"2015-12-21T01:00:00Z","reference_number":"EMA/627049/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0258-2015-ema-decision-30-october-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-3-4-benzoyl-1-piperazinyloxoacetyl-4-methoxy-7_en.pdf"},
    {"id":"17758","name":"P/0012/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for matrix applied\n\ncharacterised autologous cultured chondrocytes (MACI) (EMEA-000979-PIP01-10-...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T11:41:00Z","last_updated_date":"2018-04-18T11:41:00Z","reference_number":"EMA/28037/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-matrix-applied-characterised-autologous-cultured-chondrocytes-maci-emea-000979-pip01-10_en.pdf"},
    {"id":"17769","name":"P/0124/2012: EMA decision of 4 July 2012 on the granting of a product specific waiver for alisporivir, (EMEA-000724-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/416052/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2012-ema-decision-4-july-2012-granting-product-specific-waiver-alisporivir-emea-000724-pip02-11_en.pdf"},
    {"id":"17770","name":"P/0387/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for bezlotoxumab\n\n(Zinplava) (EMEA-001645-PIP01-14-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T13:05:00Z","last_updated_date":"2018-03-07T13:05:00Z","reference_number":"EMA/792977/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0387-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-bezlotoxumab-zinplava-emea-001645-pip01-14-m02_en.pdf"},
    {"id":"17797","name":"P/0020/2013: EMA decision of 15 February 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tiotropium bromide (monohydrate) (Spiriva Respimat, ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2013-ema-decision-15-february-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tiotropium-bromide-monohydrate-spiriva-respimat_en.pdf"},
    {"id":"17808","name":"P/116/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for sitagliptin phosphate monohydrate, metformin hydrochloride (Velmetia)\n\nEMEA-000212...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/625239/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-116-2008-european-medicines-agency-decision-1-december-2008-application-agreement-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-metformin-hydrochloride-velmetia-emea-000212_en.pdf"},
    {"id":"17828","name":"P/0332/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for dabrafenib (Tafinlar), (EMEA-001147-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T01:00:00Z","last_updated_date":"2015-02-23T01:00:00Z","reference_number":"EMA/740214/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0332-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-dabrafenib-tafinlar-emea-001147-pip01-11-m02_en.pdf"},
    {"id":"17870","name":"P/0320/2014: EMA decision of 19 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Phleum pratense (EMEA-000848-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/719217/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0320-2014-ema-decision-19-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-pollen-phleum-pratense-emea-000848-pip01-10-m01_en.pdf"},
    {"id":"17876","name":"P/0176/2013: EMA decision of 30 July 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for glucarpidase (EMEA-001391-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/375098/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2013-ema-decision-30-july-2013-agreement-paediatric-investigation-plan-granting-waiver-glucarpidase-emea-001391-pip01-12_en.pdf"},
    {"id":"17889","name":"P/0193/2012: EMA decision of 24 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen /\n\nhuman thrombin (Evicel) (EMEA-001149-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/547580/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2012-ema-decision-24-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-human-thrombin-evicel-emea-001149-pip01-11-m01_en.pdf"},
    {"id":"17900","name":"P/326/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of hazel pollen (EMEA-00095...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769413/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-326-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-hazel-pollen-emea-00095_en.pdf"},
    {"id":"17913","name":"P/236/2011: EMA decision of 30 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vatreptacog alfa (activated) (EMEA-000328-PIP02-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/766294/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-236-2011-ema-decision-30-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vatreptacog-alfa-activated-emea-000328-pip02-09_en.pdf"},
    {"id":"17943","name":"P/0209/2015: EMA decision of 18 September 2015 on the agreement of a paediatric investigation plan and on the refusal of a deferral for recombinant human tripeptidyl peptidase 1 (rhTPP1) (EMEA-001362-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/600723/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2015-ema-decision-18-september-2015-agreement-paediatric-investigation-plan-refusal-deferral-recombinant-human-tripeptidyl-peptidase-1-rhtpp1-emea-001362-pip01-12-m02_en.pdf"},
    {"id":"17969","name":"P/184/2009: European Medicines Agency decision of 7 September 2009 \n\non the agreement of a Paediatric Investigation Plan and on the granting of a waiver for human normal immunoglobulin (EMEA-000558-PIP01-09) in accordanc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/525379/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-184-2009-european-medicines-agency-decision-7-september-2009-agreement-paediatric-investigation-plan-granting-waiver-human-normal-immunoglobulin-emea-000558-pip01-09-accordanc_en.pdf"},
    {"id":"18012","name":"P/0084/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for vamorolone\n\n(EMEA-001794-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/88205/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-vamorolone-emea-001794-pip02-16_en.pdf"},
    {"id":"18026","name":"P/0137/2013: EMA decision of 21 June 2013 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira), (EMEA-000366-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/306479/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2013-ema-decision-21-june-2013-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip02-09-m02_en.pdf"},
    {"id":"18040","name":"P/0314/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime /\n\navibactam (Zavicefta), (EMEA-001313-PIP01-12-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-02-15T17:23:00Z","last_updated_date":"2018-02-15T17:23:00Z","reference_number":"EMA/679216/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0314-2017-ema-decision-31-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-ceftazidime-avibactam-zavicefta-emea-001313-pip01-12-m06_en.pdf"},
    {"id":"18056","name":"P/0294/2015: EMA decision of 3 December 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emtricitabine / tenofovir disoproxil fumarate (Truvad...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/785816/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2015-ema-decision-3-december-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-emtricitabine-tenofovir-disoproxil-fumarate-truvad_en.pdf"},
    {"id":"18071","name":"P/0068/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anacetrapib (EMEA-001100-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/85749/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anacetrapib-emea-001100-pip01-10_en.pdf"},
    {"id":"18102","name":"P/0254/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005(H5N1) l...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/595216/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0254-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-purified-antigen-fractions-inactivated-split-virion-influenza-indonesia-05-2005h5n1-l_en.pdf"},
    {"id":"18103","name":"P/0040/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for apolipoprotein A-1 (EMEA-002040-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/38346/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2017-european-medicines-agency-decision-31-january-2017-granting-product-specific-waiver-apolipoprotein-1-emea-002040-pip01-16_en.pdf"},
    {"id":"18134","name":"P/0145/2016: EMA decision of 23 May 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for KEOC liquid extract ethanolic 30 per cent (w/w) of Allium...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/269232/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2016-ema-decision-23-may-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-keoc-liquid-extract-ethanolic-30-cent-w-w-allium_en.pdf"},
    {"id":"18136","name":"P/0141/2012: EMA decision of 23 July 2012 on the granting of a product specific waiver for ezetimibe / simvastatin (Inegy and associated names) (EMEA-000006-PIP03-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T17:15:00Z","last_updated_date":"2012-08-22T17:15:00Z","reference_number":"EMA/436977/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2012-ema-decision-23-july-2012-granting-product-specific-waiver-ezetimibe-simvastatin-inegy-associated-names-emea-000006-pip03-12_en.pdf"},
    {"id":"18145","name":"P/0138/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin (Xydalba), (EMEA-000016-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/364959/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-dalbavancin-xydalba-emea-000016-pip01-07-m04_en.pdf"},
    {"id":"18179","name":"P/0043/2018: EMA decision of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pembrolizumab\n\n(Keytruda), (EMEA-001474-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/75530/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2018-ema-decision-16-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-pembrolizumab-keytruda-emea-001474-pip01-13-m01_en.pdf"},
    {"id":"18196","name":"P/184/2010: European Medicines Agency decision of 24 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for influenza virus surface antige...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/540825/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-184-2010-european-medicines-agency-decision-24-september-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-surface-antige_en.pdf"},
    {"id":"18217","name":"P/0014/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792649/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip02-10-m03_en.pdf"},
    {"id":"18268","name":"P/0006/2013: EMA decision of 21 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (Zinforo), (EMEA-000769-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/18212/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2013-ema-decision-21-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-zinforo-emea-000769-pip01-09-m03_en.pdf"},
    {"id":"18275","name":"P/0161/2015: EMA decision of 9 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-28T02:00:00Z","last_updated_date":"2015-07-28T02:00:00Z","reference_number":"EMA/440468/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2015-ema-decision-9-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip01-09-m05_en.pdf"},
    {"id":"18325","name":"P/182/2009: European Medicines Agency decision of 7 September 2009 on the granting of a product specific waiver for paracetamol / opium prepared (EMEA-000514-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/523544/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-182-2009-european-medicines-agency-decision-7-september-2009-granting-product-specific-waiver-paracetamol-opium-prepared-emea-000514-pip01-08-accordance-regulation-ec-no-1901-2006-t_en.pdf"},
    {"id":"18335","name":"P/0223/2016: EMA decision of 12 August 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for 3-[[5-chloro-\n\n1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroet...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/501690/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2016-ema-decision-12-august-2016-agreement-paediatric-investigation-plan-granting-deferral-3-5-chloro-1-3-methylsulfonylpropyl-1h-indol-2-ylmethyl-1-222-trifluoroet_en.pdf"},
    {"id":"18414","name":"P/176/2010: European Medicines Agency decision of 20 September 2010 on the granting of a product specific waiver for (R)-3(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/547266/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-176-2010-european-medicines-agency-decision-20-september-2010-granting-product-specific-waiver-r-34-7h-pyrrolo23-dpyrimidin-4-yl-1h-pyrazol-1-yl-3-cyclopentylpropanenitrilephosphate-emea-0_en.pdf"},
    {"id":"18420","name":"P/69/2009: European Medicines Agency decision of 20 April 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for calcipotriol hydrate / hydrocortiso...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2009-06-10T02:00:00Z","reference_number":"EMEA/231675/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-69-2009-european-medicines-agency-decision-20-april-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-calcipotriol-hydrate-hydrocortiso_en.pdf"},
    {"id":"18423","name":"P/0386/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for fremanezumab (EMEA-001877-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/759545/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0386-2017-ema-decision-19-december-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fremanezumab-emea-001877-pip03-17_en.pdf"},
    {"id":"18447","name":"P/325/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for anagrelide (Xagrid) (EMEA-000720-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/776034/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-325-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-anagrelide-xagrid-emea-000720-pip01-09-m02_en.pdf"},
    {"id":"18470","name":"P/0363/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (EMEA-\n\n001741-PIP01-14-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T13:05:00Z","last_updated_date":"2018-03-02T13:05:00Z","reference_number":"EMA/709763/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0363-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-emea-001741-pip01-14-m01_en.pdf"},
    {"id":"18488","name":"P/0318/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for telavancin (hydrochloride) (Vibativ), (EMEA-000239-PIP01-08-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T09:55:00Z","last_updated_date":"2017-01-30T09:55:00Z","reference_number":"EMA/741979/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0318-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-telavancin-hydrochloride-vibativ-emea-000239-pip01-08-m02_en.pdf"},
    {"id":"18500","name":"P/0356/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Fc- and CDRmodified\n\nhumanised monoclonal antibody against C5 (EMEA-002077-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/724510/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0356-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-fc-cdrmodified-humanised-monoclonal-antibody-against-c5-emea-002077-pip01-16-m01_en.pdf"},
    {"id":"18506","name":"P/0304/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for meldonium (dihydrate) (EMEA-002212-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/666635/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2017-ema-decision-31-october-2017-granting-product-specific-waiver-meldonium-dihydrate-emea-002212-pip01-17_en.pdf"},
    {"id":"18527","name":"P/0109/2016: EMA decision of 15 April 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human alpha-galactosidase A (PRX 102) (EMEA...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/203451/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2016-ema-decision-15-april-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-alpha-galactosidase-prx-102-emea_en.pdf"},
    {"id":"18548","name":"P/0072/2014: EMA decision of 1 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for concentrate of proteolytic enzymes in bromelain (NexoBrid), (EMEA-000142-PIP02-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/113587/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2014-ema-decision-1-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-concentrate-proteolytic-enzymes-bromelain-nexobrid-emea-000142-pip02-09-m03_en.pdf"},
    {"id":"18549","name":"P/137/2011: EMA decision of 10 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (S)-3'-(OH)-desazadesferrithiocin-polyether, magnesium sa...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/425992/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-137-2011-ema-decision-10-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-s-3-oh-desazadesferrithiocin-polyether-magnesium-sa_en.pdf"},
    {"id":"18579","name":"P/186/2011: EMA decision of 2 August 2011 on the granting of a product specific waiver for aflibercept (EMEA-000236-PIP03-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/500870/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-186-2011-ema-decision-2-august-2011-granting-product-specific-waiver-aflibercept-emea-000236-pip03-11_en.pdf"},
    {"id":"18594","name":"P/0037/2016: EMA decision of 12 February 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human antibody against the respiratory s...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/2822/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2016-ema-decision-12-february-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-antibody-against-respiratory-s_en.pdf"},
    {"id":"18597","name":"P/0095/2012: EMA decision of 30 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for clevidipine butyrate (Cleviprex and associated names) (EMEA-000282-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/274427/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0095-2012-ema-decision-30-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-clevidipine-butyrate-cleviprex-associated-names-emea-000282-pip01-08-m01_en.pdf"},
    {"id":"18603","name":"P/43/2012: EMA decision of 28 February 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for elacytarabine (EMEA-001121-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/130187/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-43-2012-ema-decision-28-february-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-elacytarabine-emea-001121-pip01-10_en.pdf"},
    {"id":"18617","name":"P/0064/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (Cayston) (EMEA-000827-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/138297/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-aztreonam-cayston-emea-000827-pip01-09-m04_en.pdf"},
    {"id":"18633","name":"P/252/2010:  EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-BAFF monoclonal antibody (LY2127399), (EMEA-000...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/716619/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-252-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-baff-monoclonal-antibody-ly2127399-emea-000_en.pdf"},
    {"id":"18704","name":"P/128/2009: European Medicines Agency decision of 14 July 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for rituximab (Mabthera) (EMEA-000308-PIP01-08) in accordance with Regula...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/427084/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-128-2009-european-medicines-agency-decision-14-july-2009-agreement-paediatric-investigation-plan-granting-waiver-rituximab-mabthera-emea-000308-pip01-08-accordance-regula_en.pdf"},
    {"id":"18710","name":"P/21/2008: European medicines agency decision of 28 April 2008 on the application for product specific waiver for Roflumilast PIP number EMEA-000113-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europea...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-05-16T02:00:00Z","last_updated_date":"2008-05-16T02:00:00Z","reference_number":"EMEA/211804/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-21-2008-european-medicines-agency-decision-28-april-2008-application-product-specific-waiver-roflumilast-pip-number-emea-000113-pip01-07-accordance-regulation-ec-no-1901-2006-europea_en.pdf"},
    {"id":"18730","name":"P/0039/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (EMEA-000783-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/797040/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-emea-000783-pip01-09-m01_en.pdf"},
    {"id":"18737","name":"P/0029/2017: EMA decision of 1 February 2017 on the acceptance of a modification of an agreed paediatric investigation plan for 4-amino-1-[5-chloro-2,5-dideoxy-2-fluoro-3-O-(2-methylpropanoyl)-4-[[(2-methylpropanoyl)oxy ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/23023/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0029-2017-ema-decision-1-february-2017-acceptance-modification-agreed-paediatric-investigation-plan-4-amino-1-5-chloro-25-dideoxy-2-fluoro-3-o-2-methylpropanoyl-4-2-methylpropanoyloxy_en.pdf"},
    {"id":"18742","name":"P/0194/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (EDURANT), (EMEA-000317-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/439626/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m06_en.pdf"},
    {"id":"18748","name":"P/0230/2013: EMA decision of 23 September 2013 on the granting of a product specific waiver for perindopril (erbumine) / amlodipin (besylate), (EMEA-001467-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/561630/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2013-ema-decision-23-september-2013-granting-product-specific-waiver-perindopril-erbumine-amlodipin-besylate-emea-001467-pip01-13_en.pdf"},
    {"id":"18766","name":"P/0046/2017: EMA decision of 17 February 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat),\n\n(EMEA-000402-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-18T02:00:00Z","last_updated_date":"2017-04-18T02:00:00Z","reference_number":"EMA/640003/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2017-ema-decision-17-february-2017-acceptance-modification-agreed-paediatric-investigation-plan-lacosamide-vimpat-emea-000402-pip02-11-m03_en.pdf"},
    {"id":"18771","name":"P/0146/2012: EMA decision of 24 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tobramycin (Tobi Podhaler), (EMEA-000184-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/471216/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0146-2012-ema-decision-24-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-tobramycin-tobi-podhaler-emea-000184-pip01-08-m01_en.pdf"},
    {"id":"18775","name":"P/0094/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for zanamivir (Relenza), (EMEA-001318-PIP01-12-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/281565/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-zanamivir-relenza-emea-001318-pip01-12-m01_en.pdf"},
    {"id":"18777","name":"P/148/2011: EMA decision of 9 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chemically modified extract of grass pollen from Holcus la...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/430667/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-148-2011-ema-decision-9-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chemically-modified-extract-grass-pollen-holcus-la_en.pdf"},
    {"id":"18788","name":"P/0202/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for mifepristone (EMEA–001292-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/439791/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0202-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-mifepristone-emea-001292-pip01-12-m01_en.pdf"},
    {"id":"18790","name":"P/123/2010: European medicines agency decision of 28 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for 3-[5-(2-fluorophenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid, (EMEA-000115-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/472907/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-123-2010-european-medicines-agency-decision-28-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-3-5-2-fluorophenyl-124oxadiazole-3-yl-benzoic-acid-emea-000115-p_en.pdf"},
    {"id":"18792","name":"P/52/2011: EMA decision of 4 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for decitabine (EMEA-000555-PIP01-09-M01) in accordance with Regulation (EC) No 1901/2006 of the Euro...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-05-18T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/140366/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-52-2011-ema-decision-4-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-decitabine-emea-000555-pip01-09-m01-accordance-regulation-ec-no-1901-2006-euro_en.pdf"},
    {"id":"18806","name":"P/0307/2014: EMA decision of 24 November 2014 on the granting of a product specific waiver for abaloparatide (EMEA-001667-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/624747/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2014-ema-decision-24-november-2014-granting-product-specific-waiver-abaloparatide-emea-001667-pip01-14_en.pdf"},
    {"id":"18817","name":"P/0141/2014: EMA decision of 28 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tasimelteon (EMEA-001531-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-25T02:00:00Z","last_updated_date":"2014-06-25T02:00:00Z","reference_number":"EMA/283015/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2014-ema-decision-28-may-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tasimelteon-emea-001531-pip01-13_en.pdf"},
    {"id":"18862","name":"P/0066/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for venglustat (EMEA-001716-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/87971/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2018-ema-decision-16-march-2018-granting-product-specific-waiver-venglustat-emea-001716-pip02-17_en.pdf"},
    {"id":"18863","name":"P/311/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass and birch pollen (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/773521/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-311-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-birch-pollen_en.pdf"},
    {"id":"18892","name":"P/14/2011:  EMA decision of 3 January 2011 on the review of a granted waiver for influenza virus type A, H3N2, influenza virus type A, H1N1, influenza virus type B (Fluenz) (EMEA-000249-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/717956/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-14-2011-ema-decision-3-january-2011-review-granted-waiver-influenza-virus-type-h3n2-influenza-virus-type-h1n1-influenza-virus-type-b-fluenz-emea-000249-pip01-10_en.pdf"},
    {"id":"18915","name":"P/0310/2014: EMA decision of 25 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/640509/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2014-ema-decision-25-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip01-09-m04_en.pdf"},
    {"id":"18928","name":"P/0188/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for L-asparaginase encapsulated in erythrocytes (EMEA-000341-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/571249/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-l-asparaginase-encapsulated-erythrocytes-emea-000341-pip02-09-m02_en.pdf"},
    {"id":"18942","name":"P/0320/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for amlodipine (besilate) / olmesartan (medoxomil) (EMEA-001538-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/698367/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0320-2013-ema-decision-19-december-2013-granting-product-specific-waiver-amlodipine-besilate-olmesartan-medoxomil-emea-001538-pip01-13_en.pdf"},
    {"id":"18948","name":"P/0114/2014: EMA decision of 6 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for romiplostim (Nplate) (EMEA-000653-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-11T19:00:00Z","last_updated_date":"2014-06-11T19:00:00Z","reference_number":"EMA/232690/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0114-2014-ema-decision-6-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-romiplostim-nplate-emea-000653-pip01-09-m04_en.pdf"},
    {"id":"18991","name":"P/0191/2017: EMA decision of 30 June 2017 on the granting of a product-specific waiver for abacavir / lamivudine / efavirenz (EMEA-002114-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/398222/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2017-ema-decision-30-june-2017-granting-product-specific-waiver-abacavir-lamivudine-efavirenz-emea-002114-pip01-16_en.pdf"},
    {"id":"19012","name":"P/0101/2012: EMA decision of 30 May 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for poly (oxy-1,2-ethanediyl), α-hydro-ω-methoxy-, 28B-est...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/304282/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2012-ema-decision-30-may-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-poly-oxy-12-ethanediyl-i-hydro-i0-methoxy-28b-est_en.pdf"},
    {"id":"19013","name":"P/0264/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tedizolid (phosphate) (Sivextro), (EMEA-001379-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/576579/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0264-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-tedizolid-phosphate-sivextro-emea-001379-pip01-12-m02_en.pdf"},
    {"id":"19031","name":"P/0049/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for macitentan (Opsumit) (EMEA-001032-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/133062/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-macitentan-opsumit-emea-001032-pip01-10-m02_en.pdf"},
    {"id":"19059","name":"P/0185/2012: EMA decision of 21 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for amikacin (sulfate),\n\n(EMEA-000525-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/533009/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2012-ema-decision-21-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-amikacin-sulfate-emea-000525-pip01-08-m01_en.pdf"},
    {"id":"19093","name":"P/0147/2016: EMA decision of 14 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for darbepoetin alfa\n\n(Aranesp), (EMEA-000329-PIP02-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/347579/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2016-ema-decision-14-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-darbepoetin-alfa-aranesp-emea-000329-pip02-09-m05_en.pdf"},
    {"id":"19106","name":"P/0145/2013: EMA decision of 3 July 2013on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cebranopadol (EMEA-001305-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-09T16:30:00Z","last_updated_date":"2013-08-09T16:30:00Z","reference_number":"EMA/306400/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2013-ema-decision-3-july-2013on-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cebranopadol-emea-001305-pip01-12_en.pdf"},
    {"id":"19117","name":"P/0299/2012: EMA decision of 18 December 2012 on the granting of a product-specific waiver for skeletal-muscle-derived cells (EMEA-001345-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T14:00:00Z","last_updated_date":"2013-02-11T14:00:00Z","reference_number":"EMA/737210/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2012-ema-decision-18-december-2012-granting-product-specific-waiver-skeletal-muscle-derived-cells-emea-001345-pip01-12_en.pdf"},
    {"id":"19152","name":"P/0246/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for volasertib (EMEA-000674-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/701048/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-volasertib-emea-000674-pip02-11-m01_en.pdf"},
    {"id":"19168","name":"P/0186/2012: EMA decision of 21 August 2012 on the granting of a product specific waiver for sitagliptin / atorvastatin (EMEA-001275-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T02:00:00Z","last_updated_date":"2012-09-18T02:00:00Z","reference_number":"EMA/472398/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2012-ema-decision-21-august-2012-granting-product-specific-waiver-sitagliptin-atorvastatin-emea-001275-pip01-12_en.pdf"},
    {"id":"19191","name":"P/0090/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto), (EMEA-000430-PIP01-08-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/281916/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m07_en.pdf"},
    {"id":"19202","name":"P/0088/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for nilotinib (Tasigna), (EMEA-000290-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201644/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0088-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-nilotinib-tasigna-emea-000290-pip01-08-m03_en.pdf"},
    {"id":"19212","name":"P/121/2011: EMA decision of 7 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for human normal immunoglobulin (Gammaplex), (EMEA-000830-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/355119/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-121-2011-ema-decision-7-june-2011-agreement-paediatric-investigation-plan-granting-deferral-human-normal-immunoglobulin-gammaplex-emea-000830-pip02-10_en.pdf"},
    {"id":"19214","name":"P/217/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a product specific waiver for chloroprocaine hydrochloride (EMEA-000639-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/617544/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-217-2009-european-medicines-agency-decision-30-october-2009-refusal-product-specific-waiver-chloroprocaine-hydrochloride-emea-000639-pip01-09-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"19259","name":"P/0119/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD4+ and\n\nCD8+ T cells expressing a CD19-specific chimeric antigen receptor (JCAR01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/141789/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd4-cd8-t-cells-expressing-cd19-specific-chimeric-antigen-receptor-jcar01_en.pdf"},
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    {"id":"19517","name":"P/0030/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for birch pollen extract (Betula verrucosa) (EMEA-001879-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/848794/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-birch-pollen-extract-betula-verrucosa-emea-001879-pip01-15-m01_en.pdf"},
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    {"id":"19777","name":"P/0143/2017: EMA decision of 7 June 2017 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for laquinimod (sodium) (EMEA-000972-PIP01-10-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/305260/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2017-ema-decision-7-june-2017-refusal-modification-agreed-paediatric-investigation-plan-granting-product-specific-waiver-laquinimod-sodium-emea-000972-pip01-10-m05_en.pdf"},
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    {"id":"19883","name":"P/0045/2012: EMA decision of 29 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for sunitinib (Sutent)\n\n(EMEA-000342-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/130075/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2012-ema-decision-29-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-sunitinib-sutent-emea-000342-pip01-08-m02_en.pdf"},
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    {"id":"19908","name":"P/0295/2014: EMA decision of 30 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (Brilique), (EMEA-000480-PIP01-08-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/643855/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2014-ema-decision-30-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-brilique-emea-000480-pip01-08-m07_en.pdf"},
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    {"id":"20227","name":"P/265/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of Phleum pratense and Secale cereale allerge...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/710529/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-265-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mixture-phleum-pratense-secale-cereale-allerge_en.pdf"},
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    {"id":"20278","name":"P/0121/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for palovarotene\n\n(EMEA-001662-PIP01-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/151869/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-palovarotene-emea-001662-pip01-14-m02_en.pdf"},
    {"id":"20296","name":"P/0160/2017: EMA decision of 30 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+\n\nenriched cell fraction that contains CD34+ cells transduced with lentiviral v...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/397195/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2017-ema-decision-30-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-enriched-cell-fraction-contains-cd34-cells-transduced-lentiviral-v_en.pdf"},
    {"id":"20298","name":"P/0138/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for allantoin (EMEA-001590-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T02:00:00Z","last_updated_date":"2016-07-27T02:00:00Z","reference_number":"EMA/249418/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-allantoin-emea-001590-pip01-13-m02_en.pdf"},
    {"id":"20307","name":"P/53/2008: European medicines agency decision of 20 July 2008 on the application for agreement of a Paediatric Investigation Plan for Atorvastatin calcium (Sortis and associated names) EMEA-000073-PIP01-07 in accordance ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-08T02:00:00Z","last_updated_date":"2008-09-08T02:00:00Z","reference_number":"EMEA/357907/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-53-2008-european-medicines-agency-decision-20-july-2008-application-agreement-paediatric-investigation-plan-atorvastatin-calcium-sortis-associated-names-emea-000073-pip01-07-accordance_en.pdf"},
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    {"id":"20353","name":"P/140/2011: EMA decision of 6 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for influenza virus type A, H1N1 / influenza virus type A, H3N...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/384223/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-140-2011-ema-decision-6-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-type-h1n1-influenza-virus-type-h3n_en.pdf"},
    {"id":"20357","name":"P/0128/2014: EMA decision of 22 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for abatacept (Orencia) (EMEA-000118-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-25T02:00:00Z","last_updated_date":"2014-06-25T02:00:00Z","reference_number":"EMA/252138/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0128-2014-ema-decision-22-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-abatacept-orencia-emea-000118-pip02-10-m02_en.pdf"},
    {"id":"20372","name":"P/0019/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for recombinant Clostridium difficile toxoid A / recombi...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T02:00:00Z","last_updated_date":"2018-04-17T02:00:00Z","reference_number":"EMA/31787/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2018-ema-decision-30-january-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-clostridium-difficile-toxoid-recombi_en.pdf"},
    {"id":"20436","name":"P/39/2009: European Medicines Agency decision of 20 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for fluticasone propionate / formoterol...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/153058/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-39-2009-european-medicines-agency-decision-20-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fluticasone-propionate-formoterol_en.pdf"},
    {"id":"20446","name":"P/0203/2012: EMA decision of 31 August 2012 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for split influenza virus, inactivated containing antigens equivalent to the B-like ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T14:00:00Z","last_updated_date":"2012-09-18T14:00:00Z","reference_number":"EMA/494888/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2012-ema-decision-31-august-2012-agreement-pip-granting-deferral-granting-waiver-split-influenza-virus-inactivated-containing-antigens-equivalent-b_en.pdf"},
    {"id":"20453","name":"P/4/2011:  EMA decision of 3 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pazopanib (Votrient) (EMEA-000601-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/716868/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-4-2011-ema-decision-3-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pazopanib-votrient-emea-000601-pip01-09_en.pdf"},
    {"id":"20465","name":"P/297/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pollen from dactylis glomerata, festuca pratensis, l...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683411/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-297-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-dactylis-glomerata-festuca-pratensis-l_en.pdf"},
    {"id":"20476","name":"P/0047/2018: EMA decision of 19 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for alirocumab\n\n(Praluent), (EMEA-001169-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/88692/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0047-2018-ema-decision-19-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-alirocumab-praluent-emea-001169-pip01-11-m04_en.pdf"},
    {"id":"20486","name":"P/0240/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sacubitril / valsartan (LCZ696) (EMEA-000316-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/617360/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0240-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-sacubitril-valsartan-lcz696-emea-000316-pip02-11-m02_en.pdf"},
    {"id":"20493","name":"P/0150/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sotagliflozin (EMEA-001517-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/405627/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0150-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sotagliflozin-emea-001517-pip02-14_en.pdf"},
    {"id":"20501","name":"P/0195/2017: EMA decision of 10 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for damoctocog alfa pegol (EMEA-001229-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/420384/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2017-ema-decision-10-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-damoctocog-alfa-pegol-emea-001229-pip01-11-m03_en.pdf"},
    {"id":"20531","name":"P/0131/2017: EMA decision of 7 June 2017 on the granting of a product specific waiver for buprenorphine (hydrochloride) (EMEA-002099-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/293455/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2017-ema-decision-7-june-2017-granting-product-specific-waiver-buprenorphine-hydrochloride-emea-002099-pip01-16_en.pdf"},
    {"id":"20536","name":"P/198/2009: European Medicines Agency decision of 9 October 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for A/California/7/2009 influenza-lik...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/608559/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-198-2009-european-medicines-agency-decision-9-october-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-california-7-2009-influenza-lik_en.pdf"},
    {"id":"20561","name":"P/160/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for clindamycin phosphate / tretinoin (EMEA-000892-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/530413/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-160-2010-ema-decision-27-august-2010-agreement-paediatric-investigation-plan-granting-waiver-clindamycin-phosphate-tretinoin-emea-000892-pip01-10_en.pdf"},
    {"id":"20562","name":"P/0266/2012: EMA decision of 20 November 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (2R,3S,5R)-2-(2,5-difluorophenyl)-5-[2,6-dihydro-2-(...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/721373/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2012-ema-decision-20-november-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-2r3s5r-2-25-difluorophenyl-5-26-dihydro-2_en.pdf"},
    {"id":"20576","name":"P/0045/2015: EMA decision of 6 March 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N’-bis(2-br...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-23T01:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/65014/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2015-ema-decision-6-march-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-1-methyl-2-nitro-1h-imidazole-5-ylmethyl-nn-bis2-br_en.pdf"},
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    {"id":"20609","name":"P/0075/2017: EMA decision of 17 March 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant\n\nhuman alpha-glucosidase conjugated with synthetic bismannose-6-phosphate-t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/110877/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2017-ema-decision-17-march-2017-agreement-paediatric-investigation-plan-granting-deferral-recombinant-human-alpha-glucosidase-conjugated-synthetic-bismannose-6-phosphate-t_en.pdf"},
    {"id":"20626","name":"P/0122/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA-001501-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/300768/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-emea-001501-pip01-13-m01_en.pdf"},
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    {"id":"20690","name":"P/299/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for alogliptin benzoate,\n\n(EMEA-000496-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/943611/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-299-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-alogliptin-benzoate-emea-000496-pip01-08-m02_en.pdf"},
    {"id":"20704","name":"P/0053/2014: European Medicines Agency decision of 7 March 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for elobixibat (EMEA-001484-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/50230/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2014-european-medicines-agency-decision-7-march-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-elobixibat-emea-001484-pip01-13_en.pdf"},
    {"id":"20723","name":"P/0371/2016: EMA decision of 4 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for bedaquiline\n\n(fumarate) (SIRTURO), (EMEA-000912-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/4055/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0371-2016-ema-decision-4-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-bedaquiline-fumarate-sirturo-emea-000912-pip01-10-m03_en.pdf"},
    {"id":"20753","name":"P/183/2010: European Medicines Agency decision of 24 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral for (Glycinamide, L-cysteinyl-L-phenylalanyl-L-isoleucyl-6-oxo-L-l...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/583690/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-183-2010-european-medicines-agency-decision-24-september-2010-agreement-paediatric-investigation-plan-granting-deferral-glycinamide-l-cysteinyl-l-phenylalanyl-l-isoleucyl-6-oxo-l-l_en.pdf"},
    {"id":"20758","name":"P/0179/2013: EMA decision of 30 July 2013 on the granting of a product-specific waiver for clopidogrel (hydrogen sulphate) / acetylsalicylic acid\n\n(EMEA-001463-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/419133/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2013-ema-decision-30-july-2013-granting-product-specific-waiver-clopidogrel-hydrogen-sulphate-acetylsalicylic-acid-emea-001463-pip01-13_en.pdf"},
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    {"id":"20762","name":"P/0265/2012: EMA decision of 20 November 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for levofloxacin (hemihydrate), (EMEA-001211-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/646979/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2012-ema-decision-20-november-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-levofloxacin-hemihydrate-emea-001211-pip01-11_en.pdf"},
    {"id":"20767","name":"P/189/2009: European Medicines Agency decision of 22 September 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for clopidogrel (Clopidogrel Winth...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/PDCO/583267","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-189-2009-european-medicines-agency-decision-22-september-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-clopidogrel-clopidogrel-winth_en.pdf"},
    {"id":"20779","name":"P/0089/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for N. meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / N...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/211923/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-n-meningitidis-serogroup-polysaccharide-conjugated-tetanus-toxoid-n_en.pdf"},
    {"id":"20794","name":"P/0026/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib\n\n(Olumiant), (EMEA-001220-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/850457/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-olumiant-emea-001220-pip01-11-m02_en.pdf"},
    {"id":"20809","name":"P/264/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy)\n\n(EMEA-000117-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/848187/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-264-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip01-07-m03_en.pdf"},
    {"id":"20825","name":"P/0189/2013: EMA decision of 9 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names) (EMEA-000573-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-10T13:20:00Z","last_updated_date":"2013-09-10T13:20:00Z","reference_number":"EMA/476169/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2013-ema-decision-9-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip01-09-m04_en.pdf"},
    {"id":"20880","name":"P/0297/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for nilotinib (Tasigna) (EMEA-000290-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/792883/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0297-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-nilotinib-tasigna-emea-000290-pip01-08-m04_en.pdf"},
    {"id":"20886","name":"P/0205/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21) (Velp...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/568199/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-sucroferric-oxyhydroxide-mixture-iron-iii-oxyhydroxide-sucrose-starch-pa21-velp_en.pdf"},
    {"id":"20922","name":"P/126/2011: EMA decision of 7 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for octocog alfa (EMEA-001064-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/421237/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-126-2011-ema-decision-7-june-2011-agreement-paediatric-investigation-plan-granting-deferral-octocog-alfa-emea-001064-pip01-10_en.pdf"},
    {"id":"20969","name":"P/94/2010: European Medicines Agency decision of 2 June 2010 on the agreement of a paediatric investigation plan and on the refusal of a deferral  and on the granting of a waiver for peginterferon alfa-2a (Pegasys) (EMEA...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/330327/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-94-2010-european-medicines-agency-decision-2-june-2010-agreement-paediatric-investigation-plan-refusal-deferral-granting-waiver-peginterferon-alfa-2a-pegasys-emea_en.pdf"},
    {"id":"20971","name":"P/0281/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for lebrikizumab (EMEA-001053-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/688239/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0281-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-lebrikizumab-emea-001053-pip01-10-m03_en.pdf"},
    {"id":"20990","name":"P/0120/2012: EMA decision of 3 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet hydrochloride (Mimpara), (EMEA-000078-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/412355/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2012-ema-decision-3-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-cinacalcet-hydrochloride-mimpara-emea-000078-pip01-07-m03_en.pdf"},
    {"id":"20995","name":"P/0393/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren\n\n(Translarna), (EMEA-000115-PIP01-07-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/797360/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0393-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip01-07-m09_en.pdf"},
    {"id":"21004","name":"P/0006/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for human heterologous liver cells (EMEA-000067-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1361/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-human-heterologous-liver-cells-emea-000067-pip02-11-m02_en.pdf"},
    {"id":"21007","name":"P/0290/2016: EMA decision of 4 November 2016 on the granting of a product-specific waiver for Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) (EMEA-001140-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-06T01:00:00Z","last_updated_date":"2017-01-06T01:00:00Z","reference_number":"EMA/667230/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0290-2016-ema-decision-4-november-2016-granting-product-specific-waiver-allogeneic-mesenchymal-precursor-cells-rexlemestrocel-l-emea-001140-pip02-15_en.pdf"},
    {"id":"21050","name":"P/0048/2014: EMA decision of 8 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for rubidium (82Rb) chloride (EMEA-000882-PIP03-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/58300/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0048-2014-ema-decision-8-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-rubidium-82rb-chloride-emea-000882-pip03-11-m01_en.pdf"},
    {"id":"21067","name":"P/0101/2016: EMA decision of 15 April 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for certolizumab pegol (Cimzia), (EMEA-001071-PIP03-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/188946/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2016-ema-decision-15-april-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-certolizumab-pegol-cimzia-emea-001071-pip03-14_en.pdf"},
    {"id":"21095","name":"P/0072/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for selumetinib (EMEA-\n\n001585-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/83697/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-selumetinib-emea-001585-pip01-13-m02_en.pdf"},
    {"id":"21145","name":"P/268/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor (EMEA-001173-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/592149/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-268-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-lumacaftor-emea-001173-pip01-11-m01_en.pdf"},
    {"id":"21150","name":"P/0161/2014: EMA decision of 12 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (EMEA-000069-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/329215/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2014-ema-decision-12-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip02-10-m03_en.pdf"},
    {"id":"21173","name":"P/0057/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin (EMEA-000016-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/102646/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-dalbavancin-emea-000016-pip01-07-m01_en.pdf"},
    {"id":"21175","name":"P/0242/2013: EMA decision of 24 September 2013 on the granting of a product specific waiver for calcium (citrate) / colecalciferol (EMEA-001480-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/496911/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2013-ema-decision-24-september-2013-granting-product-specific-waiver-calcium-citrate-colecalciferol-emea-001480-pip01-13_en.pdf"},
    {"id":"21183","name":"P/145/2010:  European Medicines Agency decision of 30 July 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vedolizumab (EMEA-000645-PIP01-09)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/469701/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-145-2010-european-medicines-agency-decision-30-july-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vedolizumab-emea-000645-pip01-09_en.pdf"},
    {"id":"21236","name":"P/0059/2018: EMA decision of 16 March 2018 on the granting of a product specific waiver for dapagliflozin / metformin (hydrochloride)\n\n(EMEA-001151-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/75594/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2018-ema-decision-16-march-2018-granting-product-specific-waiver-dapagliflozin-metformin-hydrochloride-emea-001151-pip02-17_en.pdf"},
    {"id":"21252","name":"P/107/2008: European Medicines Agency decision of 28 November 2008 on the application for agreement of a Paediatric Investigation Plan for skimmed cow's milk powder EMEA-000201-PIP01-08 in accordance with Regulation (EC)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/625236/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-107-2008-european-medicines-agency-decision-28-november-2008-application-agreement-paediatric-investigation-plan-skimmed-cows-milk-powder-emea-000201-pip01-08-accordance-regulation-ec_en.pdf"},
    {"id":"21253","name":"P/0088/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for levamisole (hydrochloride) (EMEA-001885-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/136529/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0088-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-waiver-levamisole-hydrochloride-emea-001885-pip01-15_en.pdf"},
    {"id":"21294","name":"P/16/2008: European medicines agency decision of 31 March 2008 on the application for product specific waiver for Naproxcinod (EMEA-000104-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of the European Parliam...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-04-22T02:00:00Z","last_updated_date":"2008-04-22T02:00:00Z","reference_number":"EMEA/157227/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-16-2008-european-medicines-agency-decision-31-march-2008-application-product-specific-waiver-naproxcinod-emea-000104-pip01-07-accordance-regulation-ec-no-1901-2006-european-parliam_en.pdf"},
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    {"id":"21322","name":"P/0015/2012: EMA decision of 24 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for purified tetanus toxoid / inactivated type 1 poliovi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/8126/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2012-ema-decision-24-january-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-purified-tetanus-toxoid-inactivated-type-1-poliovi_en.pdf"},
    {"id":"21333","name":"P/206/2011: EMA decision of 31 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for cholic acid, (EMEA-\n\n000651-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/688412/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-206-2011-ema-decision-31-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-cholic-acid-emea-000651-pip01-09-m02_en.pdf"},
    {"id":"21336","name":"P/292/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral for 40K pegylated recombinant blood coagulation factor IX, (EMEA-000731-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683312/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-292-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-40k-pegylated-recombinant-blood-coagulation-factor-ix-emea-000731-pip01-09_en.pdf"},
    {"id":"21358","name":"P/0051/2018: EMA decision of 22 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam\n\n(Briviact) (EMEA-000332-PIP01-08-M13)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T13:35:00Z","last_updated_date":"2018-04-17T13:35:00Z","reference_number":"EMA/102425/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0051-2018-ema-decision-22-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-briviact-emea-000332-pip01-08-m13_en.pdf"},
    {"id":"21370","name":"P/72/2008: European medicines agency decision of 20 August 2008\n\non the application for agreement of a Paediatric Investigation Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000254-PIP01-08), in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/431920/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-72-2008-european-medicines-agency-decision-20-august-2008-application-agreement-paediatric-investigation-plan-nicotinic-acid-simvastatin-laropiprant-emea-000254-pip01-08-accordance-w_en.pdf"},
    {"id":"21386","name":"P/0166/2014: EMA decision of 8 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (EMEA-000715-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/392184/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2014-ema-decision-8-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-emea-000715-pip02-11-m01_en.pdf"},
    {"id":"21392","name":"P/0122/2016: EMA decision of 29 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/287097/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2016-ema-decision-29-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip01-07-m07_en.pdf"},
    {"id":"21419","name":"P/0094/2012: EMA decision of 30 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for nalfurafine (hydrochloride) (EMEA-000266-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/266429/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2012-ema-decision-30-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-nalfurafine-hydrochloride-emea-000266-pip01-08-m01_en.pdf"},
    {"id":"21421","name":"P/0184/2013: EMA decision of 31 July 2013 on the granting of a product-specific waiver for capsici acris extractum spissum normatum (EMEA-001409-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/418994/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2013-ema-decision-31-july-2013-granting-product-specific-waiver-capsici-acris-extractum-spissum-normatum-emea-001409-pip01-12_en.pdf"},
    {"id":"21431","name":"P/0230/2012: EMA decision of 5 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Livazo and associated names), (EMEA-000054-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/625236/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2012-ema-decision-5-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-livazo-associated-names-emea-000054-pip01-07-m03_en.pdf"},
    {"id":"21455","name":"P/222/2011: EMA decision of 27 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for rabeprazole (sodium) (Pariet and associated names), (EMEA-000055-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/703629/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-222-2011-ema-decision-27-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-rabeprazole-sodium-pariet-associated-names-emea-000055-pip01-07-m04_en.pdf"},
    {"id":"21474","name":"P/0009/2012: EMA decision of 24 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for darbepoetin alfa\n\n(Aranesp and associated names) (EMEA-000329-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/43583/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2012-ema-decision-24-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-darbepoetin-alfa-aranesp-associated-names-emea-000329-pip02-09-m01_en.pdf"},
    {"id":"21475","name":"P/0027/2016: EMA decision of 29 January 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for abrilumab (EMEA-001671-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/2820/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2016-ema-decision-29-january-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-abrilumab-emea-001671-pip01-14_en.pdf"},
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    {"id":"21554","name":"P/0142/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ciclosporin (EMEA-000575-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/398291/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-ciclosporin-emea-000575-pip01-09-m03_en.pdf"},
    {"id":"21571","name":"P/144/2010:  Agency decision of 30 July 2010 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for (3R,4R)-4-methyl-3-(methyl-1H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-1-piper...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/469865/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-144-2010-agency-decision-30-july-2010-agreement-pip-granting-deferral-granting-waiver-3r4r-4-methyl-3-methyl-1h-pyrrolo23-dpyrimidin-4-ylamino-i2-oxo-1-piper_en.pdf"},
    {"id":"21589","name":"P/244/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant Bet v1 folding variant (rBet v1-FV), (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/678209/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-244-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-bet-v1-folding-variant-rbet-v1-fv-eme_en.pdf"},
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    {"id":"21633","name":"P/126/2010: European Medicines Agency decision of 28 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for modified grass pollen extract, (EMEA-000284-PIP01-08-M01) in accordance wi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/472908/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-126-2010-european-medicines-agency-decision-28-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-modified-grass-pollen-extract-emea-000284-pip01-08-m01-accordance-wi_en.pdf"},
    {"id":"21651","name":"P/125/2011: EMA decision of 7 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for elvitegravir / emtricitabine / tenofovir disoproxil (as fu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/359899/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-125-2011-ema-decision-7-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-elvitegravir-emtricitabine-tenofovir-disoproxil-fu_en.pdf"},
    {"id":"21658","name":"P/0049/2015: EMA decision of 6 March 2015 on the granting of a product-specific waiver for oxycodone (hydrochloride) / naloxone (hydrochloride) (EMEA-001700-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-24T01:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/49368/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2015-ema-decision-6-march-2015-granting-product-specific-waiver-oxycodone-hydrochloride-naloxone-hydrochloride-emea-001700-pip01-14_en.pdf"},
    {"id":"21686","name":"P/0028/2016: EMA decision of 29 January 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 17 beta-estradiol / etonogestrel (EMEA-001718-PIP01-1...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/23043/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2016-ema-decision-29-january-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-17-beta-estradiol-etonogestrel-emea-001718-pip01-1_en.pdf"},
    {"id":"21698","name":"P/0025/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for damoctocog alfa pegol (EMEA-001229-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1076/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-damoctocog-alfa-pegol-emea-001229-pip01-11-m02_en.pdf"},
    {"id":"21712","name":"P/234/2010: Acceptance of a modification of an agreed PIP for influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1) like strain (A/Sol...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-27T00:00:00Z","last_updated_date":"2010-12-21T00:00:00Z","reference_number":"EMA/672567/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-234-2010-acceptance-modification-agreed-pip-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-inactivated-following-strains-solomon-islands-3-2006-h1n1-strain-sol_en.pdf"},
    {"id":"21715","name":"P/0298/2012: EMA decision of 18 December 2012 on the granting of a product-specific waiver for ivermectin (EMEA-001334-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T14:00:00Z","last_updated_date":"2013-02-11T14:00:00Z","reference_number":"EMA/736952/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2012-ema-decision-18-december-2012-granting-product-specific-waiver-ivermectin-emea-001334-pip01-12_en.pdf"},
    {"id":"21717","name":"P/226/2009: European Medicines Agency Decision of 4 November 2009 on the granting of a product specific waiver for olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide (EMEA-000666-PIP01-09) in accordance wit...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:09:21Z","last_updated_date":"2009-12-23T00:09:21Z","reference_number":"EMEA/693323/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-226-2009-european-medicines-agency-decision-4-november-2009-granting-product-specific-waiver-olmesartan-medoxomil-amlodipine-besilate-hydrochlorothiazide-emea-000666-pip01-09-accordance-wit_en.pdf"},
    {"id":"21733","name":"P/0175/2013: EMA decision of 30 July 2013 on the granting of a product-specific waiver for lopinavir / lamivudine / ritonavir / zidovudine (EMEA-001368-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/367930/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2013-ema-decision-30-july-2013-granting-product-specific-waiver-lopinavir-lamivudine-ritonavir-zidovudine-emea-001368-pip01-12_en.pdf"},
    {"id":"21751","name":"P/0325/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for calcium (carbonate) / cholecalciferol (in combination with zoledronic acid (monohydrate)) (EMEA-001690-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/759441/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0325-2014-ema-decision-19-december-2014-granting-product-specific-waiver-calcium-carbonate-cholecalciferol-combination-zoledronic-acid-monohydrate-emea-001690-pip01-14_en.pdf"},
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    {"id":"21774","name":"P/0309/2014: EMA decision of 24 November 2014 on the granting of a product specific waiver for varicella-zoster virus (live, attenuated) (Zostavax) (EMEA-001672-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/624743/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0309-2014-ema-decision-24-november-2014-granting-product-specific-waiver-varicella-zoster-virus-live-attenuated-zostavax-emea-001672-pip01-14_en.pdf"},
    {"id":"21791","name":"P/54/2009: European Medicines Agency decision of 24 March 2009 on the granting of a product specific waiver for bisoprolol fumarate / acetylsalicylic acid (EMEA-000449-PIP01-08) in accordance with Regulation (EC) No 1901...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/167372/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-54-2009-european-medicines-agency-decision-24-march-2009-granting-product-specific-waiver-bisoprolol-fumarate-acetylsalicylic-acid-emea-000449-pip01-08-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"21794","name":"P/0213/2014: EMA decision of 1 September 2014 on the granting of a product specific waiver for perindopril / bisoprolol (EMEA-001497-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/467314/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2014-ema-decision-1-september-2014-granting-product-specific-waiver-perindopril-bisoprolol-emea-001497-pip01-13_en.pdf"},
    {"id":"21809","name":"P/2/2007: European medicines agency decision of 11 December 2007 on the application for a product specific waiver for Everolimus (EMEA-000019-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of the European Parl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2007-12-20T00:00:00Z","last_updated_date":"2007-12-20T00:00:00Z","reference_number":"EMEA/575610/2007","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-2-2007-european-medicines-agency-decision-11-december-2007-application-product-specific-waiver-everolimus-emea-000019-pip01-07-accordance-regulation-ec-no-1901-2006-european-parl_en.pdf"},
    {"id":"21824","name":"P/0023/2014: EMA decision of 22 January 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for 9-cis-retinyl acetate (EMEA-001453-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/738903/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2014-ema-decision-22-january-2014-agreement-paediatric-investigation-plan-granting-deferral-9-cis-retinyl-acetate-emea-001453-pip01-13_en.pdf"},
    {"id":"21844","name":"P/0259/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for selepressin (EMEA-\n\n000506-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585444/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-selepressin-emea-000506-pip01-08-m02_en.pdf"},
    {"id":"21865","name":"P/287/2011: EMA decision of 1 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for purified antigen fractions of inactivated split virion...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/912704/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-287-2011-ema-decision-1-december-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-purified-antigen-fractions-inactivated-split-virion_en.pdf"},
    {"id":"21871","name":"P/167/2011: EMA decision of 6 July 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for risperidone\n\n(Risperdal and associated names) (EMEA-001034-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/484972/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-167-2011-ema-decision-6-july-2011-agreement-paediatric-investigation-plan-granting-waiver-risperidone-risperdal-associated-names-emea-001034-pip01-10_en.pdf"},
    {"id":"21883","name":"P/0207/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Fusion\n\nProtein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689) (E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/466902/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-linking-coagulation-factor-viia-albumin-rviia-fp-csl689-e_en.pdf"},
    {"id":"21911","name":"P/0224/2014: EMA decision of 5 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for maraviroc (Celsentri), (EMEA-000020-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/469464/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2014-ema-decision-5-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-maraviroc-celsentri-emea-000020-pip01-07-m04_en.pdf"},
    {"id":"21923","name":"P/0100/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for decitabine (Dacogen), (EMEA-000555-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201519/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0100-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-decitabine-dacogen-emea-000555-pip01-09-m03_en.pdf"},
    {"id":"21932","name":"P/0300/2016: EMA decision of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for monoclonal IgG1 anti-influenza A antibody (EMEA-001831-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-06T01:00:00Z","last_updated_date":"2017-01-06T01:00:00Z","reference_number":"EMA/639659/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2016-ema-decision-4-november-2016-agreement-paediatric-investigation-plan-granting-deferral-monoclonal-igg1-anti-influenza-antibody-emea-001831-pip01-15_en.pdf"},
    {"id":"21950","name":"P/0027/2013: EMA decision of 26 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dimethyl fumarate, (EMEA-000832-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/66153/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2013-ema-decision-26-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-dimethyl-fumarate-emea-000832-pip01-10-m01_en.pdf"},
    {"id":"21972","name":"P/0198/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion protein consisting of human coagulation factor IX attached to the Fc dom...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/483690/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2013-ema-decision-2-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-consisting-human-coagulation-factor-ix-attached-fc-dom_en.pdf"},
    {"id":"22006","name":"P/0007/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag (Revolade) (EMEA-000170-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/776065/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-eltrombopag-revolade-emea-000170-pip02-10-m02_en.pdf"},
    {"id":"22024","name":"P/0168/2013: EMA decision of 29 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant Varicella-zoster-virus (VZV) glycoprotein-E ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/393025/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2013-ema-decision-29-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-varicella-zoster-virus-vzv-glycoprotein-e_en.pdf"},
    {"id":"22029","name":"P/0011/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga) (EMEA-000597-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/784278/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip02-10-m02_en.pdf"},
    {"id":"22036","name":"P/0023/2017: EMA decision of 13 February 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ciprofloxacin (hydrochloride) (EMEA-001563-PIP02-15...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-18T02:00:00Z","last_updated_date":"2017-04-18T02:00:00Z","reference_number":"EMA/36089/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2017-ema-decision-13-february-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ciprofloxacin-hydrochloride-emea-001563-pip02-15_en.pdf"},
    {"id":"22044","name":"P/0257/2015: EMA decision of 30 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous CD34+ haematopoietic stem cells transduced...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T01:00:00Z","last_updated_date":"2015-12-21T01:00:00Z","reference_number":"EMA/617562/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0257-2015-ema-decision-30-october-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-cd34-haematopoietic-stem-cells-transduced_en.pdf"},
    {"id":"22049","name":"P/3/2007: European medicines agency decision of 11 December 2007 on the application for a product specific waiver for Atacand Plus and associated names, Candesartan/Hydrochlorothiazide (EMEA-000030-PIP01-07) in accordanc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2007-12-20T00:00:00Z","last_updated_date":"2007-12-20T00:00:00Z","reference_number":"EMEA/575732/2007","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-3-2007-european-medicines-agency-decision-11-december-2007-application-product-specific-waiver-atacand-plus-associated-names-candesartan-hydrochlorothiazide-emea-000030-pip01-07-accordanc_en.pdf"},
    {"id":"22061","name":"P/0156/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cariprazine (hydrochloride) (EMEA-001652-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/398316/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cariprazine-hydrochloride-emea-001652-pip01-14_en.pdf"},
    {"id":"22063","name":"P/0194/2012: EMA decision of 24 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pitolisant (EMEA-001176-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T13:05:00Z","last_updated_date":"2012-09-18T13:05:00Z","reference_number":"EMA/547633/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2012-ema-decision-24-august-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pitolisant-emea-001176-pip01-11_en.pdf"},
    {"id":"22065","name":"P/0176/2016: EMA decision of 1 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza)\n\n(EMEA-000128-PIP01-07-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-02-22T01:00:00Z","last_updated_date":"2017-02-22T01:00:00Z","reference_number":"EMA/408672/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2016-ema-decision-1-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m07_en.pdf"},
    {"id":"22073","name":"P/0211/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for brentuximab vedotin\n\n(Adcetris), (EMEA-000980-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/472138/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-brentuximab-vedotin-adcetris-emea-000980-pip01-10-m04_en.pdf"},
    {"id":"22079","name":"P/0130/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for exenatide (Byetta, Bydureon), (EMEA-000689-PIP01-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/264477/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-exenatide-byetta-bydureon-emea-000689-pip01-09-m06_en.pdf"},
    {"id":"22092","name":"P/258/2011: EMA decision of 26 October 2011 on the granting of a product specific waiver for 4-[[9-[(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-\n\ntrifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol (CC-930) (EMEA-001...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/751564/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-258-2011-ema-decision-26-october-2011-granting-product-specific-waiver-4-9-3s-tetrahydro-3-furanyl-8-246-trifluorophenylamino-9h-purin-2-ylamino-trans-cyclohexanol-cc-930-emea-001_en.pdf"},
    {"id":"22095","name":"P/0083/2013: EMA decision of 26 April 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for ceftazidime / avibactam (EMEA-001313-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/202542/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2013-ema-decision-26-april-2013-agreement-paediatric-investigation-plan-granting-deferral-ceftazidime-avibactam-emea-001313-pip01-12_en.pdf"},
    {"id":"22112","name":"P/0080/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for pridopyrimidione\n\nSMN2 Splicing Modifier (EMEA-002070-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/91848/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-pridopyrimidione-smn2-splicing-modifier-emea-002070-pip01-16-m01_en.pdf"},
    {"id":"22125","name":"P/0092/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bucelipase alfa (EMEA-000822-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/179906/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-bucelipase-alfa-emea-000822-pip01-09-m01_en.pdf"},
    {"id":"22135","name":"P/71/2011: EMA decision of 4 April 2011 on the granting of a product specific waiver for iloperidone (EMEA-000995-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/221083/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-71-2011-ema-decision-4-april-2011-granting-product-specific-waiver-iloperidone-emea-000995-pip01-10_en.pdf"},
    {"id":"22137","name":"P/0208/2014: EMA decision of 8 August 2014 on the granting of a product specific waiver for tirasemtiv (EMEA-001594-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/439330/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2014-ema-decision-8-august-2014-granting-product-specific-waiver-tirasemtiv-emea-001594-pip02-13_en.pdf"},
    {"id":"22160","name":"P/0156/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for fosaprepitant (Ivemend), (EMEA-000406-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/478451/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-fosaprepitant-ivemend-emea-000406-pip01-08-m03_en.pdf"},
    {"id":"22161","name":"P/0009/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for clevidipine butyrate (Cleviprex and associated names) (EMEA-000282-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/10229/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-clevidipine-butyrate-cleviprex-associated-names-emea-000282-pip_en.pdf"},
    {"id":"22172","name":"P/0050/2013: European medicines agency decision of 1 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and asso...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/85745/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2013-european-medicines-agency-decision-1-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-asso_en.pdf"},
    {"id":"22196","name":"P/0224/2015: EMA decision of 2 October 2015 on the granting of a product specific waiver for botulinum Neurotoxin Type A (EMEA-001788-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-19T01:00:00Z","last_updated_date":"2015-11-19T01:00:00Z","reference_number":"EMA/568184/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2015-ema-decision-2-october-2015-granting-product-specific-waiver-botulinum-neurotoxin-type-emea-001788-pip01-15_en.pdf"},
    {"id":"22216","name":"P/0299/2013: EMA decision of 29 November 2013 on the agreement of a paediatric investigation plan and on granting for sodium benzylpenilloate / benzylpenicilloyl octa- L-lysine (EMEA-001398-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/692933/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2013-ema-decision-29-november-2013-agreement-paediatric-investigation-plan-granting-sodium-benzylpenilloate-benzylpenicilloyl-octa-l-lysine-emea-001398-pip02-13_en.pdf"},
    {"id":"22252","name":"P/0142/2014: EMA decision of 13 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for lubiprostone (Amitiza) (EMEA-000245-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/252147/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2014-ema-decision-13-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-lubiprostone-amitiza-emea-000245-pip01-08-m02_en.pdf"},
    {"id":"22255","name":"P/0014/2012: EMA decision of 24 January 2012 on the granting of a product specific waiver for netupitant / palonosetron (EMEA-001198-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/973120/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2012-ema-decision-24-january-2012-granting-product-specific-waiver-netupitant-palonosetron-emea-001198-pip01-11_en.pdf"},
    {"id":"22262","name":"P/0126/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto) (EMEA-000430-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-22T02:00:00Z","last_updated_date":"2016-07-22T02:00:00Z","reference_number":"EMA/293994/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0126-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m09_en.pdf"},
    {"id":"22272","name":"P/0194/2016: EMA decision of 15 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for metreleptin (EMEA-001701-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-19T02:00:00Z","last_updated_date":"2016-09-19T02:00:00Z","reference_number":"EMA/408691/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2016-ema-decision-15-july-2016-agreement-paediatric-investigation-plan-granting-deferral-metreleptin-emea-001701-pip01-14_en.pdf"},
    {"id":"22287","name":"P/0151/2013: EMA decision of 5 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for voriconazole (Vfend), (EMEA-000191-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/342140/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2013-ema-decision-5-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-voriconazole-vfend-emea-000191-pip01-08-m05_en.pdf"},
    {"id":"22305","name":"P/0248/2013: EMA decision of 10 October 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sofosbuvir / ledipasvir (EMEA-001411-PIP01-12)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/587280/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0248-2013-ema-decision-10-october-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sofosbuvir-ledipasvir-emea-001411-pip01-12_en.pdf"},
    {"id":"22314","name":"P/227/2010: EMA decision of 28 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral for partially purified bromelain (EMEA-000142-PIP02-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/651486/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-227-2010-ema-decision-28-october-2010-agreement-paediatric-investigation-plan-granting-deferral-partially-purified-bromelain-emea-000142-pip02-09_en.pdf"},
    {"id":"22316","name":"P/210/2011: EMA decision of 2 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis),\n\n(EMEA-000183-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/554940/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-210-2011-ema-decision-2-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip01-08-m01_en.pdf"},
    {"id":"22352","name":"P/0301/2014: EMA decision of 24 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/651537/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0301-2014-ema-decision-24-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m06_en.pdf"},
    {"id":"22355","name":"P/210/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for prucalopride succinate (Resolor)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/615425/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-210-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-prucalopride-succinate-resolor_en.pdf"},
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    {"id":"22366","name":"P/264/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for phleum pratense allergen extract (EMEA-000924-PIP01-1...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/670698/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-264-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-phleum-pratense-allergen-extract-emea-000924-pip01-1_en.pdf"},
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    {"id":"22376","name":"P/0004/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for bevacizumab (Avastin), (EMEA-000056-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/738884/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-bevacizumab-avastin-emea-000056-pip01-07-m02_en.pdf"},
    {"id":"22377","name":"P/0103/2016: EMA decision of 4 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for coagulation Factor VIIa (Recombinant) (EMEA-001203-PIP02-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/203384/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2016-ema-decision-4-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-coagulation-factor-viia-recombinant-emea-001203-pip02-14-m01_en.pdf"},
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    {"id":"22419","name":"P/0167/2014: EMA decision of 8 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ozenoxacin (EMEA-000981-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/344600/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2014-ema-decision-8-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-ozenoxacin-emea-000981-pip01-10-m04_en.pdf"},
    {"id":"22481","name":"P/120/2009: European Medicines Agency decision of 15 June 2009 on the granting of a product specific waiver for aliskiren hemifumarate / amlodipine besilate (EMEA-000517-PIP01-08) in accordance with Regulation (EC) No 19...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351843/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-120-2009-european-medicines-agency-decision-15-june-2009-granting-product-specific-waiver-aliskiren-hemifumarate-amlodipine-besilate-emea-000517-pip01-08-accordance-regulation-ec-no-19_en.pdf"},
    {"id":"22493","name":"P/137/2010: EMA decision of 30 July 2010 on the refusal of a modification of an agreed paediatric investigation plan for tapentadol hydrochloride (EMEA-000018-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-09-07T02:00:00Z","last_updated_date":"2010-09-07T02:00:00Z","reference_number":"EMA/469385/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-137-2010-ema-decision-30-july-2010-refusal-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-emea-000018-pip01-07-m02_en.pdf"},
    {"id":"22533","name":"P/0173/2014: EMA decision of 11 July 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for vigabatrin (EMEA-000717-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-31T12:00:00Z","last_updated_date":"2014-07-31T12:00:00Z","reference_number":"EMA/354911/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2014-ema-decision-11-july-2014-agreement-paediatric-investigation-plan-granting-waiver-vigabatrin-emea-000717-pip02-13_en.pdf"},
    {"id":"22540","name":"P/87/2009: European medicines agency decision of 18 May 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for rolofylline (EMEA-000275-PIP01-08) in accordance with Regulation (EC)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/288303/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-87-2009-european-medicines-agency-decision-18-may-2009-agreement-paediatric-investigation-plan-granting-deferral-rolofylline-emea-000275-pip01-08-accordance-regulation-ec_en.pdf"},
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    {"id":"22572","name":"P/221/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 12 Grass Pollen Extract and Cult...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/629199/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-221-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-12-grass-pollen-extract-cult_en.pdf"},
    {"id":"22579","name":"P/0307/2016: EMA decision of 4 November 2016 on the granting of a product-specific waiver for amlodipine / valsartan / hydrochlorothiazide (EMEA-002006-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T01:00:00Z","last_updated_date":"2017-01-10T01:00:00Z","reference_number":"EMA/707931/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2016-ema-decision-4-november-2016-granting-product-specific-waiver-amlodipine-valsartan-hydrochlorothiazide-emea-002006-pip01-16_en.pdf"},
    {"id":"22623","name":"P/147/2009: EMEA decision on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for aqueous extract of grass pollen from Dactylis glomerata, Festuca pratensis, Holcus lanatus, Lolium...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/431574/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-147-2009-emea-decision-agreement-pip-granting-deferral-granting-waiver-aqueous-extract-grass-pollen-dactylis-glomerata-festuca-pratensis-holcus-lanatus-lolium_en.pdf"},
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    {"id":"22639","name":"P/0026/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for vancomycin (EMEA-001311-PIP01-12-01-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/3765/2016 corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-vancomycin-emea-001311-pip01-12-01-m01_en.pdf"},
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    {"id":"22671","name":"P/0275/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Phleum pratense (EMEA-000848-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/690870/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0275-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-pollen-phleum-pratense-emea-000848-pip01-10-m02_en.pdf"},
    {"id":"22677","name":"P/0060/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ferumoxytol, (Rienso) (EMEA-000373-PIP02-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/137334/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0060-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-ferumoxytol-rienso-emea-000373-pip02-09-m04_en.pdf"},
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    {"id":"22817","name":"P/0034/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lucerastat (EMEA-002095-PIP01-16)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/848802/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2018-ema-decision-30-january-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lucerastat-emea-002095-pip01-16_en.pdf"},
    {"id":"22819","name":"P/0273/2014: EMA decision of 27 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for molidustat (sodium) (EMEA-001546-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-04T01:00:00Z","last_updated_date":"2014-12-04T01:00:00Z","reference_number":"EMA/624619/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0273-2014-ema-decision-27-october-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-molidustat-sodium-emea-001546-pip01-13_en.pdf"},
    {"id":"22830","name":"P/0260/2014: EMA decision of 29 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names), (EMEA-000573-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/586421/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2014-ema-decision-29-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip01-09-m05_en.pdf"},
    {"id":"22855","name":"P/0229/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed PIP for Purified Tetanus Toxoid / Inactivated Type 1, 2 and 3 Poliovirus / Purified Pertussis Toxoid / Haemophilus influenza...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/492665/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2013-ema-decision-23-september-2013-acceptance-modification-agreed-pip-purified-tetanus-toxoid-inactivated-type-1-2-3-poliovirus-purified-pertussis-toxoid-haemophilus-influenza_en.pdf"},
    {"id":"22857","name":"P/72/2010: European Medicines Agency decision of 5 May 2010 on the acceptance of a modification of an agreed paediatric investigation plan for icatibant acetate (Firazyr) (EMEA-000408-PIP01-08-M02) in accordance with Reg...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/249207/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-72-2010-european-medicines-agency-decision-5-may-2010-acceptance-modification-agreed-paediatric-investigation-plan-icatibant-acetate-firazyr-emea-000408-pip01-08-m02-accordance-reg_en.pdf"},
    {"id":"22858","name":"P/0166/2012: EMA decision of 26 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for daclatasvir (EMEA-001191-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T16:00:00Z","last_updated_date":"2012-08-23T16:00:00Z","reference_number":"EMA/476938/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2012-ema-decision-26-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-daclatasvir-emea-001191-pip01-11_en.pdf"},
    {"id":"22871","name":"P/15/2008: European medicines agency decision of 31 March 2008 on the application for product-specific waiver for fosfluridine tidoxil (EMEA-000094-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of the Europea...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-04-22T02:00:00Z","last_updated_date":"2008-04-22T02:00:00Z","reference_number":"EMEA/155447/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-15-2008-european-medicines-agency-decision-31-march-2008-application-product-specific-waiver-fosfluridine-tidoxil-emea-000094-pip01-07-accordance-regulation-ec-no-1901-2006-europea_en.pdf"},
    {"id":"22899","name":"P/0068/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant dimer of 6 kD early secretory antigenic target / recombinant 10 kD culture filtrat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"P/0068/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-dimer-6-kd-early-secretory-antigenic-target-recombinant-10-kd-culture-filtrat_en.pdf"},
    {"id":"22916","name":"P/0125/2012: EMA decision of of 4 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for bimatoprost (Lumigan 0.1 mg/ml eye drops, solution, Lumigan 0.3 mg/ml eye drops, solution), (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/435533/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2012-ema-decision-4-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-bimatoprost-lumigan-01-mg-ml-eye-drops-solution-lumigan-03-mg-ml-eye-drops-solution_en.pdf"},
    {"id":"22925","name":"P/0180/2015: EMA decision of 7 August 2015 on the granting of a product-specific waiver for rifamycin (EMEA-001754-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-24T02:00:00Z","last_updated_date":"2015-09-24T02:00:00Z","reference_number":"EMA/508333/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2015-ema-decision-7-august-2015-granting-product-specific-waiver-rifamycin-emea-001754-pip01-15_en.pdf"},
    {"id":"22940","name":"P/239/2010: EMA decision of 05 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for infliximab (Remicade), (EMEA-000549-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/678121/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-239-2010-ema-decision-05-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-infliximab-remicade-emea-000549-pip01-09-m01_en.pdf"},
    {"id":"22962","name":"P/0084/2012: EMA decision of 21 May 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for liraglutide (Victoza) (EMEA-000128-PIP02-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/304164/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2012-ema-decision-21-may-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-liraglutide-victoza-emea-000128-pip02-09_en.pdf"},
    {"id":"22967","name":"P/0188/2016: EMA decision of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant dimer of 6 kD early secretory antigenic target / recombinant 10 kD culture filtrate...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/399717/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-dimer-6-kd-early-secretory-antigenic-target-recombinant-10-kd-culture-filtrate_en.pdf"},
    {"id":"22978","name":"P/86/2008:Alanine,arginine,aspartic acid,cysteine/cystine,glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonin...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/526469/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-86-2008alaninearginineaspartic-acidcysteine-cystineglutamic-acid-glycine-histidine-isoleucine-leucine-lysine-monohydrate-methionine-ornithine-hydrochloride-phenylalanine-proline-serine-taurine_en.pdf"},
    {"id":"22980","name":"P/159/2011: EMA decision of 4 July 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ocrelizumab (EMEA-000310-PIP03-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-08T02:00:00Z","last_updated_date":"2011-08-08T02:00:00Z","reference_number":"EMA/424485/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-159-2011-ema-decision-4-july-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ocrelizumab-emea-000310-pip03-10_en.pdf"},
    {"id":"22986","name":"P/0032/2012: EMA decision of 2 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine\n\n(hydrochloride) (Procoralan), (EMEA-000628-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/62972/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2012-ema-decision-2-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-procoralan-emea-000628-pip01-09-m02_en.pdf"},
    {"id":"22988","name":"P/51/2011: EMA decision of 4 March 2011on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil fumarate) (EMEA-000533 PIP01-08-M01) in accordance with Regulation (EC) No 1...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-04-19T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/78723/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-51-2011-ema-decision-4-march-2011on-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-emea-000533-pip01-08-m01-accordance-regulation-ec-no-1_en.pdf"},
    {"id":"22992","name":"P/78/2011: EMA decision of 6 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for fibrinogen\n\n(human plasma-derived) (EMEA-000457-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/248805/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-78-2011-ema-decision-6-april-2011-agreement-paediatric-investigation-plan-granting-deferral-fibrinogen-human-plasma-derived-emea-000457-pip02-10_en.pdf"},
    {"id":"23010","name":"P/0074/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan for clonidine (Hydrochloride) (EMEA-001316-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/114384/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-clonidine-hydrochloride-emea-001316-pip01-12_en.pdf"},
    {"id":"23072","name":"P/0166/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for aciclovir (Sitavig and associated names), (EMEA-001066-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/348027/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2017-ema-decision-3-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-aciclovir-sitavig-associated-names-emea-001066-pip02-11-m02_en.pdf"},
    {"id":"23084","name":"P/0175/2017: EMA decision of 3 July 2017 on the granting of a product specific waiver for dezamizumab (EMEA-002110-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/354124/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2017-ema-decision-3-july-2017-granting-product-specific-waiver-dezamizumab-emea-002110-pip02-17_en.pdf"},
    {"id":"23122","name":"P/0308/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / abacavir / lamivudine (Triumeq) (EMEA-001219-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/792871/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-dolutegravir-abacavir-lamivudine-triumeq-emea-001219-pip01-11-m02_en.pdf"},
    {"id":"23133","name":"P/0137/2017: EMA decision of 7 June 2017 on the agreement of a paediatric investigation plan and on the refusal of a deferral for rimiducid\n\n(EMEA-001870-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/293457/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2017-ema-decision-7-june-2017-agreement-paediatric-investigation-plan-refusal-deferral-rimiducid-emea-001870-pip01-15_en.pdf"},
    {"id":"23138","name":"P/85/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for imatinib (mesilate) (Glivec) (EMEA-000463-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/254705/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-85-2011-ema-decision-8-april-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-imatinib-mesilate-glivec-emea-000463-pip02-10_en.pdf"},
    {"id":"23143","name":"P/0199/2012: EMA decision of 24 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ex-vivo expanded human autologous epithelium containin...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T14:00:00Z","last_updated_date":"2012-09-18T14:00:00Z","reference_number":"EMA/534631/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2012-ema-decision-24-august-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ex-vivo-expanded-human-autologous-epithelium-containin_en.pdf"},
    {"id":"23158","name":"P/346/2010: EMA decision of 21 December 2010 on the acceptance of a modification of an agreed paediatric investigation plan for paliperidone / paliperidone palmitate (Invega) (EMEA-000014-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T00:00:00Z","last_updated_date":"2011-01-25T00:00:00Z","reference_number":"EMA/830331/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-346-2010-ema-decision-21-december-2010-acceptance-modification-agreed-paediatric-investigation-plan-paliperidone-paliperidone-palmitate-invega-emea-000014-pip01-07-m05_en.pdf"},
    {"id":"23225","name":"P/226/2010: EMA decision of 27 October 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for atazanavir\n\nsulphate (Reyataz), (EMA-000804-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/649948/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-226-2010-ema-decision-27-october-2010-agreement-paediatric-investigation-plan-granting-waiver-atazanavir-sulphate-reyataz-ema-000804-pip01-09_en.pdf"},
    {"id":"23229","name":"P/230/2010: EMA decision of 23 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for moxifloxacin\n\nhydrochloride (Avalox and associated names; Octegra and associated names; Acti...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T00:00:00Z","last_updated_date":"2010-12-21T00:00:00Z","reference_number":"EMA/656733/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-230-2010-ema-decision-23-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-moxifloxacin-hydrochloride-avalox-associated-names-octegra-associated-names-acti_en.pdf"},
    {"id":"23274","name":"P/133/2011: EMA decision of 8 June 2011 on the granting of a product specific waiver for Gallium [68 Ga] Chloride / Germanium [68 Ge] Chloride (EMEA-001102-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/418845/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-133-2011-ema-decision-8-june-2011-granting-product-specific-waiver-gallium-68-ga-chloride-germanium-68-ge-chloride-emea-001102-pip01-10_en.pdf"},
    {"id":"23279","name":"P/67/2008: European medicines agency decision of 15 August 2008 on the application for product specific waiver for everolimus (EMEA-00019-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliame...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMEA/424631/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-67-2008-european-medicines-agency-decision-15-august-2008-application-product-specific-waiver-everolimus-emea-00019-pip01-08-accordance-regulation-ec-no-1901-2006-european-parliame_en.pdf"},
    {"id":"23287","name":"P/0198/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for (3-((4-Benzoyl-1-\n\npiperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1H-1,2,4-triazol-1-yl)-1H-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:21:00Z","last_updated_date":"2016-09-22T16:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-3-4-benzoyl-1-piperazinyloxoacetyl-4-methoxy-7-3-methyl-1h-124-triazol-1-yl-1h_en.pdf"},
    {"id":"23321","name":"P/0126/2012: EMA decision of of 4 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for (3aR,4S,7aR)-octahydro-4-hydroxy-4-[(3-methylphenyl)ethynyl]-1H-indole-1-carboxylic acid meth...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/411114/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0126-2012-ema-decision-4-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-3ar4s7ar-octahydro-4-hydroxy-4-3-methylphenylethynyl-1h-indole-1-carboxylic-acid-meth_en.pdf"},
    {"id":"23323","name":"P/0284/2017: EMA decision of 4 October 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for\n\npyridopyrimidione SMN2 splicing modifier (EMEA-002070-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/541730/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0284-2017-ema-decision-4-october-2017-agreement-paediatric-investigation-plan-granting-deferral-pyridopyrimidione-smn2-splicing-modifier-emea-002070-pip01-16_en.pdf"},
    {"id":"23363","name":"P/0161/2013: EMA decision of 29 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/379357/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2013-ema-decision-29-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m03_en.pdf"},
    {"id":"23381","name":"P/0257/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for zuretinol (acetate)\n\n(EMEA-001453-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585770/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0257-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-zuretinol-acetate-emea-001453-pip01-13-m01_en.pdf"},
    {"id":"23396","name":"P/0129/2015: EMA decision of 5 June 2015 on the granting of a product-specific waiver for ranolazine / dronedarone (EMEA-001726-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/347667/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2015-ema-decision-5-june-2015-granting-product-specific-waiver-ranolazine-dronedarone-emea-001726-pip01-14_en.pdf"},
    {"id":"23400","name":"P/0071/2017: EMA decision of 17 March 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for avelumab\n\n(EMEA-001849-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/91509/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2017-ema-decision-17-march-2017-agreement-paediatric-investigation-plan-granting-deferral-avelumab-emea-001849-pip02-15_en.pdf"},
    {"id":"23410","name":"P/29/2011: EMA decision of 28 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for oseltamivir\n\n(phosphate) (Tamiflu) (EMEA-000365-PIP01-08-M02) in accordance with Regulation (E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"EMA/58239/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-29-2011-ema-decision-28-january-2011-acceptance-modification-agreed-paediatric-investigation-plan-oseltamivir-phosphate-tamiflu-emea-000365-pip01-08-m02-accordance-regulation-e_en.pdf"},
    {"id":"23415","name":"P/0035/2016: EMA decision of 1 February 2016 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for 13C-Methacetin (EMEA-001844-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/23036/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0035-2016-ema-decision-1-february-2016-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-13c-methacetin-emea-001844-pip01-15_en.pdf"},
    {"id":"23438","name":"P/243/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for [(3S)-6-({2',6'-Dimethyl-4'-[3-(methylsulfonyl) propo...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/501874/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-243-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-3s-6-26-dimethyl-4-3-methylsulfonyl-propo_en.pdf"},
    {"id":"23467","name":"P/0031/2015: EMA decision of 12 February 2015 on the acceptance of a modification of an agreed paediatric investigation plan for allantoin (EMEA-001590-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/75713/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0031-2015-ema-decision-12-february-2015-acceptance-modification-agreed-paediatric-investigation-plan-allantoin-emea-001590-pip01-13-m01_en.pdf"},
    {"id":"23478","name":"P/0294/2014: EMA decision of 30 October 2014on the acceptance of a modification of an agreed paediatric investigation plan for MAGE-A3 recombinant protein (EMEA-001099-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-09T01:00:00Z","last_updated_date":"2014-12-09T01:00:00Z","reference_number":"EMA/590079/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2014-ema-decision-30-october-2014on-acceptance-modification-agreed-paediatric-investigation-plan-mage-a3-recombinant-protein-emea-001099-pip02-11-m01_en.pdf"},
    {"id":"23506","name":"P/0134/2015: EMA decision of 15 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab (RoActemra), (EMEA-000309-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-07T02:00:00Z","last_updated_date":"2015-07-07T02:00:00Z","reference_number":"EMA/383650/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0134-2015-ema-decision-15-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-tocilizumab-roactemra-emea-000309-pip01-08-m06_en.pdf"},
    {"id":"23520","name":"P/80/2010: European Medicines Agency decision of 7 May 2010\n\non the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for taspoglutide (EMEA-000649-PIP01-09) i...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/265545/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-80-2010-european-medicines-agency-decision-7-may-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-taspoglutide-emea-000649-pip01-09-i_en.pdf"},
    {"id":"23567","name":"P/0299/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for olaratumab (EMEA-\n\n001760-PIP01-15-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:17:00Z","last_updated_date":"2017-01-20T16:17:00Z","reference_number":"P/0299/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-olaratumab-emea-001760-pip01-15-m01_en.pdf"},
    {"id":"23570","name":"P/0102/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for alirocumab (EMEA-\n\n001169-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/188342/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2016-ema-decision-15-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-alirocumab-emea-001169-pip01-11-m01_en.pdf"},
    {"id":"23574","name":"P/241/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aluminium hydroxide adsorbed, depigmented glutaraldeh...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/709776/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-241-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaraldeh_en.pdf"},
    {"id":"23580","name":"P/329/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Aqueous allergen extract of birch, alder and hazel po...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/778420/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-329-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aqueous-allergen-extract-birch-alder-hazel-po_en.pdf"},
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    {"id":"23602","name":"P/0203/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for cangrelor\n\n(tetrasodium), (EMEA-001348-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/391891/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-cangrelor-tetrasodium-emea-001348-pip01-12-m01_en.pdf"},
    {"id":"23619","name":"P/0234/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for brexpiprazole\n\n(EMEA-001185-PIP01-11-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/579489/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2016-ema-decision-9-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-brexpiprazole-emea-001185-pip01-11-m03_en.pdf"},
    {"id":"23649","name":"P/0153/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for calcipotriol (EMEA-001606-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/382980/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-calcipotriol-emea-001606-pip02-14_en.pdf"},
    {"id":"23665","name":"P/0010/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for fosaprepitant (Ivemend) (EMEA-000406-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/10721/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-fosaprepitant-ivemend-emea-000406-pip01-08-m04_en.pdf"},
    {"id":"23673","name":"P/0229/2015: EMA decision of 22 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for meropenem trihydrate (in combination with vaborbactam) (EMEA-001731-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2015-12-22T13:00:00Z","reference_number":"EMA/624853/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2015-ema-decision-22-october-2015-agreement-paediatric-investigation-plan-granting-deferral-meropenem-trihydrate-combination-vaborbactam-emea-001731-pip01-14_en.pdf"},
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    {"id":"23994","name":"P/0220/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for anti programmed death-ligand 1 (PD-L1) monoclonal antibody (MPDL3280A) (EMEA-001638-PIP01-14-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-24T12:00:00Z","last_updated_date":"2015-11-24T12:00:00Z","reference_number":"EMA/568187/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-anti-programmed-death-ligand-1-pd-l1-monoclonal-antibody-mpdl3280a-emea-001638-pip01-14_en.pdf"},
    {"id":"23996","name":"P/0084/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant L-asparaginase (EMEA-000013-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/187814/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-l-asparaginase-emea-000013-pip01-07-m03_en.pdf"},
    {"id":"24000","name":"P/0110/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis), (EMEA-000183-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/296248/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip01-08-m03_en.pdf"},
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    {"id":"24053","name":"P/0065/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for meropenem (EMEA-000898-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/131047/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0065-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-meropenem-emea-000898-pip01-10-m02_en.pdf"},
    {"id":"24058","name":"P/0301/2016: EMA decision of 4 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for immunoglobulin G2, anti-(human α-calcitonin gene-rel...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-09T01:00:00Z","last_updated_date":"2017-01-09T01:00:00Z","reference_number":"EMA/501874/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0301-2016-ema-decision-4-november-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-immunoglobulin-g2-anti-human-i-calcitonin-gene-rel_en.pdf"},
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    {"id":"24077","name":"P/0020/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sirukumab (EMEA-001043-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/866518/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-sirukumab-emea-001043-pip01-10-m02_en.pdf"},
    {"id":"24113","name":"P/107/2009: European Medicines Agency decision of 19 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for esomeprazole sodium, esomeprazole m...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351948/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-107-2009-european-medicines-agency-decision-19-june-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-esomeprazole-sodium-esomeprazole-m_en.pdf"},
    {"id":"24116","name":"P/0347/2017: EMA decision of 1 December 2017 on the refusal of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names) (EMEA-001231-PIP02-13-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T11:48:00Z","last_updated_date":"2018-03-02T11:48:00Z","reference_number":"EMA/724148/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0347-2017-ema-decision-1-december-2017-refusal-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m05_en.pdf"},
    {"id":"24130","name":"P/79/2009: European Medicines Agency decision of 24 April 2009 on the agreement of a Paediatric Investigation Plan and on granting of a deferral and on granting of a waiver for purified antigen fractions of inactivated s...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2009-06-10T02:00:00Z","reference_number":"EMEA/227977/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-79-2009-european-medicines-agency-decision-24-april-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-purified-antigen-fractions-inactivated-s_en.pdf"},
    {"id":"24132","name":"P/134/2010:  European Medicines Agency decision of 28 July 2010 on the granting of a product specific waiver for amlodipine besilate/perindopril tert-butylamine (EMEA-000823-PIP01-10) in accordance with Regulation (EC) N...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/465065/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-134-2010-european-medicines-agency-decision-28-july-2010-granting-product-specific-waiver-amlodipine-besilate-perindopril-tert-butylamine-emea-000823-pip01-10-accordance-regulation-ec-n_en.pdf"},
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    {"id":"24215","name":"P/0259/2012: EMA decision of of 19 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab\n\n(Humira) (EMEA-000366-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/680269/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2012-ema-decision-19-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip01-08-m05_en.pdf"},
    {"id":"24227","name":"P/0039/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for valsartan / indapamide (EMEA-001377-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/23964/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2013-ema-decision-27-february-2013-granting-product-specific-waiver-valsartan-indapamide-emea-001377-pip01-12_en.pdf"},
    {"id":"24255","name":"P/0072/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for glibenclamide (EMEA-001324-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/137572/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-glibenclamide-emea-001324-pip01-12-m01_en.pdf"},
    {"id":"24256","name":"P/291/2011: EMA decision of 2 December 2011 on the agreement of a paediatric investigation plan for dopamine (hydrochloride) (EMEA-001105-\n\nPIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/922736/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-291-2011-ema-decision-2-december-2011-agreement-paediatric-investigation-plan-dopamine-hydrochloride-emea-001105-pip01-10_en.pdf"},
    {"id":"24265","name":"P/0349/2016: EMA decision of 2 December 2016 on the refusal of a product specific waiver for terguride (hydrogenmaleate) (EMEA-002015-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/757984/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0349-2016-ema-decision-2-december-2016-refusal-product-specific-waiver-terguride-hydrogenmaleate-emea-002015-pip01-16_en.pdf"},
    {"id":"24267","name":"P/0007/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (EMEA-000069-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/4124/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip01-07-m04_en.pdf"},
    {"id":"24286","name":"P/0219/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA-\n\n001501-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/513635/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-emea-001501-pip01-13-m03_en.pdf"},
    {"id":"24326","name":"P/0043/2016: EMA decision of 26 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and T...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/133034/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0043-2016-ema-decision-26-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-t_en.pdf"},
    {"id":"24331","name":"P/108/2012: EMA decision of 8 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (Ilaris), (EMEA-000060-PIP02-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/326702/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-108-2012-ema-decision-8-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-canakinumab-ilaris-emea-000060-pip02-08-m05_en.pdf"},
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    {"id":"24406","name":"P/0203/2015: EMA decision of 4 September 2015 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for azithromycin (EMEA-001777-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/570271/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2015-ema-decision-4-september-2015-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-azithromycin-emea-001777-pip01-15_en.pdf"},
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    {"id":"24470","name":"P/0296/2014: EMA decision of 7 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin (EMEA-000780-PIP01-09-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/651535/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0296-2014-ema-decision-7-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-midostaurin-emea-000780-pip01-09-m01_en.pdf"},
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    {"id":"24476","name":"P/83/2008: European medicines agency decision of of 14 October 2008 \n\non the application for agreement of a Paediatric Investigation Plan for valsartan (Diovan) (EMEA-000005-PIP01-07) in accordance with Regulation (EC) N...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/523615/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-83-2008-european-medicines-agency-decision-14-october-2008-application-agreement-paediatric-investigation-plan-valsartan-diovan-emea-000005-pip01-07-accordance-regulation-ec-n_en.pdf"},
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    {"id":"24496","name":"P/0251/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime / avibactam (EMEA-001313-PIP01-12-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/619847/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-ceftazidime-avibactam-emea-001313-pip01-12-m04_en.pdf"},
    {"id":"24521","name":"P/0270/2014: EMA decision of 27 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for regorafenib (Stivarga), (EMEA-001178-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-10T01:00:00Z","last_updated_date":"2014-12-10T01:00:00Z","reference_number":"EMA/587625/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0270-2014-ema-decision-27-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-regorafenib-stivarga-emea-001178-pip01-11-m01_en.pdf"},
    {"id":"24537","name":"P/0295/2015: EMA decision of 3 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (Gammaplex), (EMEA-000830-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/773326/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2015-ema-decision-3-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-gammaplex-emea-000830-pip02-10-m02_en.pdf"},
    {"id":"24538","name":"P/0310/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for erenumab (EMEA-\n\n001664-PIP02-15-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-02-16T01:00:00Z","last_updated_date":"2018-02-16T01:00:00Z","reference_number":"EMA/666628/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2017-ema-decision-31-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-erenumab-emea-001664-pip02-15-m01_en.pdf"},
    {"id":"24539","name":"P/0300/2014: EMA decision of 24 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for L-asparaginase encapsulated in erythrocytes (EMEA-000341-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/624771/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2014-ema-decision-24-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-l-asparaginase-encapsulated-erythrocytes-emea-000341-pip02-09-m01_en.pdf"},
    {"id":"24544","name":"P/0125/2017: EMA decision of 5 May 2017 on the granting of a product-specific waiver for ramipril / indapamide (EMEA-002081-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/253504/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2017-ema-decision-5-may-2017-granting-product-specific-waiver-ramipril-indapamide-emea-002081-pip01-16_en.pdf"},
    {"id":"24553","name":"P/0032/2014: European Medicines Agency decision of 3 March 2014 on the granting of a product specific waiver for ertugliflozin / sitagliptin (EMEA-001534-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-03-20T01:00:00Z","last_updated_date":"2014-03-20T01:00:00Z","reference_number":"EMA/42215/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2014-european-medicines-agency-decision-3-march-2014-granting-product-specific-waiver-ertugliflozin-sitagliptin-emea-001534-pip01-13_en.pdf"},
    {"id":"24554","name":"P/296/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for pollen from Phleum pratense (EMEA-000848-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/697311/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-296-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-phleum-pratense-emea-000848-pip01-10_en.pdf"},
    {"id":"24564","name":"P/0216/2013: EMA decision of 30 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / triphenylacetic acid - 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/493077/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2013-ema-decision-30-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-triphenylacetic-acid-4-1r-2-6-2-26-dichlorobenzyloxyethoxy_en.pdf"},
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    {"id":"24572","name":"P/263/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mixture of Phleum pratense, Dactylis glomerata, Festu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/710530/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-263-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mixture-phleum-pratense-dactylis-glomerata-festu_en.pdf"},
    {"id":"24584","name":"P/0272/2013: EMA decision of 30 October 2013 on the granting of a product specific waiver for (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]p...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/587446/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0272-2013-ema-decision-30-october-2013-granting-product-specific-waiver-4r5r-1-4-4-33-dibutyl-7-dimethylamino-2345-tetrahydro-4-hydroxy-11-dioxido-1-benzothiepin-5-ylphenoxymethylp_en.pdf"},
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    {"id":"24669","name":"P/53/2011:  EMA decision of 4 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for coagulation Factor IX (Recombinant), (EMEA-000661-PIP01-09-M02) in accordance with Regulation (E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/78825/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-53-2011-ema-decision-4-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-coagulation-factor-ix-recombinant-emea-000661-pip01-09-m02-accordance-regulation-e_en.pdf"},
    {"id":"24690","name":"P/0186/2016: EMA decision of 15 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for cadazolid\n\n(EMEA-001108-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-19T02:00:00Z","last_updated_date":"2016-09-19T02:00:00Z","reference_number":"EMA/394469/2016 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2016-ema-decision-15-july-2016-agreement-paediatric-investigation-plan-granting-deferral-cadazolid-emea-001108-pip02-15_en.pdf"},
    {"id":"24704","name":"P/0092/2018: EMA decision of 16 March 2018 on the granting of a product specific waiver for dapagliflozin / saxagliptin / metformin (hydrochloride)\n\n(EMEA-002249-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/75592/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2018-ema-decision-16-march-2018-granting-product-specific-waiver-dapagliflozin-saxagliptin-metformin-hydrochloride-emea-002249-pip01-17_en.pdf"},
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    {"id":"24725","name":"P/169/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for vildagliptin / metformin hydrochloride (Eucreas), (EMEA-000703-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/477499/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-169-2010-european-medicines-agency-decision-3-september-2010-granting-product-specific-waiver-vildagliptin-metformin-hydrochloride-eucreas-emea-000703-pip01-09_en.pdf"},
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    {"id":"24764","name":"P/78/2008: European medicines agency decision of 14 September 2008\n\non the application for product specific waiver for bortezomib (Velcade)\n\nEMEA-000233-PIP01-08 in accordance with Regulation (EC) No 1901/2006 of the Eur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-10-10T02:00:00Z","last_updated_date":"2008-10-10T02:00:00Z","reference_number":"EMEA/466976/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-78-2008-european-medicines-agency-decision-14-september-2008-application-product-specific-waiver-bortezomib-velcade-emea-000233-pip01-08-accordance-regulation-ec-no-1901-2006-eur_en.pdf"},
    {"id":"24767","name":"P/301/2010: EMA decision of 22 December 2010 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for pollen from dactylis glomarata (8%), lolium perenne (8%), phleum pratense (8%),...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683424/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-301-2010-ema-decision-22-december-2010-agreement-pip-granting-deferral-granting-waiver-pollen-dactylis-glomarata-8-lolium-perenne-8-phleum-pratense-8_en.pdf"},
    {"id":"24768","name":"P/0315/2015: EMA decision of 21 December 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for ethosuximide (EMEA-001617-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/781916/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0315-2015-ema-decision-21-december-2015-agreement-paediatric-investigation-plan-granting-waiver-ethosuximide-emea-001617-pip01-14_en.pdf"},
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    {"id":"24947","name":"P/0319/2016: EMA decision of 2 December 2016 on the refusal of a modification of an agreed paediatric investigation plan for tapentadol\n\n(hydrochloride) (Palexia and associated names, Yantil and associated names, Tapenta...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T09:55:00Z","last_updated_date":"2017-01-30T09:55:00Z","reference_number":"EMA/758229/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0319-2016-ema-decision-2-december-2016-refusal-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapenta_en.pdf"},
    {"id":"24977","name":"P/118/2011: EMA decision of 23 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for autologous oral mucosal epithelial cells, (EMEA-001004-PI...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/338204/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-118-2011-ema-decision-23-may-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-oral-mucosal-epithelial-cells-emea-001004-pi_en.pdf"},
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    {"id":"24990","name":"P/211/2011: EMA decision of 2 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/647403/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-211-2011-ema-decision-2-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-emea-000332-pip01-08-m04_en.pdf"},
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    {"id":"25164","name":"P/0070/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tanezumab (EMEA-001635-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/102436/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tanezumab-emea-001635-pip03-17_en.pdf"},
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    {"id":"25403","name":"P/0039/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for deferasirox, (Exjade) (EMEA-001103-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/89606/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-deferasirox-exjade-emea-001103-pip01-10-m02_en.pdf"},
    {"id":"25485","name":"P/66/2010: European Medicines Agency decision on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for avotermin (EMEA-000634-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/265398/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-66-2010-european-medicines-agency-decision-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-avotermin-emea-000634-pip01-09_en.pdf"},
    {"id":"25487","name":"P/127/2009: European Medicines Agency decision of 14 July 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for Telavancin hydrochloride (EMEA-000239-PIP01-08) in accordance with ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/426945/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-127-2009-european-medicines-agency-decision-14-july-2009-agreement-paediatric-investigation-plan-granting-deferral-telavancin-hydrochloride-emea-000239-pip01-08-accordance_en.pdf"},
    {"id":"25490","name":"P/0177/2015: EMA decision of 7 August 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for recombinant human nerve growth factor (EMEA-001729-PIP01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-22T02:00:00Z","last_updated_date":"2015-09-22T02:00:00Z","reference_number":"EMA/473457/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2015-ema-decision-7-august-2015-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-recombinant-human-nerve-growth-factor-emea-001729-pip01_en.pdf"},
    {"id":"25516","name":"P/62/2011: EMA decision of 7 March 2011\n\non the agreement of a paediatric investigation plan and on the granting of a waiver for bucelipase alfa (EMEA-000822-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/158091/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-62-2011-ema-decision-7-march-2011-agreement-paediatric-investigation-plan-granting-waiver-bucelipase-alfa-emea-000822-pip01-09-accordance-regulation-ec-no-1901-2006-t_en.pdf"},
    {"id":"25517","name":"P/0223/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Fusion\n\nProtein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689) (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/460047/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-linking-coagulation-factor-viia-albumin-rviia-fp-csl689_en.pdf"},
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    {"id":"25528","name":"P/0092/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole\n\n(Noxafil), (EMEA-000468-PIP02-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/181811/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m03_en.pdf"},
    {"id":"25531","name":"P/0039/2016: EMA decision of 19 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin (EMEA-000780-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/103092/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2016-ema-decision-19-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-midostaurin-emea-000780-pip01-09-m02_en.pdf"},
    {"id":"25551","name":"P/0281/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab\n\n(Nucala), (EMEA-000069-PIP04-13-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T15:28:00Z","last_updated_date":"2017-01-23T15:28:00Z","reference_number":"EMA/704428/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0281-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-nucala-emea-000069-pip04-13-m01_en.pdf"},
    {"id":"25561","name":"P/0265/2015: EMA decision of 6 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir (Vitekta), (EMEA-000968-PIP02-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/688246/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2015-ema-decision-6-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-vitekta-emea-000968-pip02-11-m04_en.pdf"},
    {"id":"25591","name":"P/43/2009: European Medicines Agency decision of 23 March 2009 on the refusal of a product specific waiver for dirucotide acetate (EMEA-000433-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Par...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/167848/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-43-2009-european-medicines-agency-decision-23-march-2009-refusal-product-specific-waiver-dirucotide-acetate-emea-000433-pip01-08-accordance-regulation-ec-no-1901-2006-european-par_en.pdf"},
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    {"id":"25632","name":"P/0278/2013: EMA decision of 31 October 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for idelalisib (EMEA-001350-PIP02-13)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/650681/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0278-2013-ema-decision-31-october-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-idelalisib-emea-001350-pip02-13_en.pdf"},
    {"id":"25639","name":"P/36/2009: European Medicines Agency decision of 24 February 2009 on the granting of a product-specific waiver for lapatinib ditosylate monohydrate (Tyverb) (EMEA-000404-PIP01-08) in accordance with Regulation (EC) No 19...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/90351/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-36-2009-european-medicines-agency-decision-24-february-2009-granting-product-specific-waiver-lapatinib-ditosylate-monohydrate-tyverb-emea-000404-pip01-08-accordance-regulation-ec-no-19_en.pdf"},
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    {"id":"25693","name":"P/0070/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for evolocumab (Repatha), (EMEA-001268-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/104827/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-evolocumab-repatha-emea-001268-pip01-12-m02_en.pdf"},
    {"id":"25720","name":"P/0283/2013: EMA decision of 8 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-12-06T01:00:00Z","last_updated_date":"2013-12-06T01:00:00Z","reference_number":"EMA/648087/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0283-2013-ema-decision-8-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
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    {"id":"25803","name":"P/188/2009: European Medicines Agency decision of 11 September 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for vicriviroc maleate (EMEA-000122-PIP01-07-M01) in accordance with Regu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/525373/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-188-2009-european-medicines-agency-decision-11-september-2009-acceptance-modification-agreed-paediatric-investigation-plan-vicriviroc-maleate-emea-000122-pip01-07-m01-accordance-regu_en.pdf"},
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    {"id":"25914","name":"P/45/2011: EMA decision of the 3 March 2011 on the granting of a product specific waiver for atorvastatin (L-lysine salt) / amlodipine (besilate) (EMEA-000719-PIP02-10) in accordance with Regulation (EC) No 1901/2006 of ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-05T02:00:00Z","last_updated_date":"2011-04-05T02:00:00Z","reference_number":"EMA/115356/201","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-45-2011-ema-decision-3-march-2011-granting-product-specific-waiver-atorvastatin-l-lysine-salt-amlodipine-besilate-emea-000719-pip02-10-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"25929","name":"P/0232/2014: EMA decision of 5 September 2014 on the granting of a product specific waiver for bromfenac (sodium sesquihydrate) (EMEA-001595-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/469254/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2014-ema-decision-5-september-2014-granting-product-specific-waiver-bromfenac-sodium-sesquihydrate-emea-001595-pip01-13_en.pdf"},
    {"id":"25953","name":"P/0031/2013: EMA decision of 26 February 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for hydrocortisone, (EMEA-001283-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/65467/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0031-2013-ema-decision-26-february-2013-agreement-paediatric-investigation-plan-granting-waiver-hydrocortisone-emea-001283-pip01-12_en.pdf"},
    {"id":"25996","name":"P/0023/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydr...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/28678/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2018-ema-decision-30-january-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-14-dihydro-1-2r-2-2-methoxyphenyl-2-tetrahydr_en.pdf"},
    {"id":"26008","name":"P/0025/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/29826/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-n-13-dicyclohexyl-6-hydroxy-24-dioxo-1234-tetrahydro-5-pyrimidinylcarbonylglycine_en.pdf"},
    {"id":"26012","name":"P/0037/2012: EMA decision of 20 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for romiplostim (Nplate),\n\n(EMEA-000653-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/2090/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2012-ema-decision-20-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-romiplostim-nplate-emea-000653-pip01-09-m01_en.pdf"},
    {"id":"26013","name":"P/0252/2013: EMA decision of 29 October 2013 on the modification of an agreed paediatric investigation plan for denosumab (Xgeva (previously Amgiva), Prolia), (EMEA-000145-PIP01-07-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/602409/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2013-ema-decision-29-october-2013-modification-agreed-paediatric-investigation-plan-denosumab-xgeva-previously-amgiva-prolia-emea-000145-pip01-07-m06_en.pdf"},
    {"id":"26025","name":"P/0237/2014: EMA decision of 19 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tap...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-10-09T02:00:00Z","last_updated_date":"2014-10-09T02:00:00Z","reference_number":"EMA/555776/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0237-2014-ema-decision-19-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tap_en.pdf"},
    {"id":"26037","name":"P/0101/2015: EMA decision of 8 May 2015 on the granting of a product specific waiver for L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser (EMEA-001719-PIP01-14)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/211869/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2015-ema-decision-8-may-2015-granting-product-specific-waiver-l-pyr-l-glu-l-gln-l-leu-l-glu-l-arg-l-ala-l-leu-l-asn-l-ser-l-ser-emea-001719-pip01-14_en.pdf"},
    {"id":"26063","name":"P/0169/2012: EMA decision of 27 July 2012 on the refusal of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta)\n\n(EMEA-000057-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/485855/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2012-ema-decision-27-july-2012-refusal-modification-agreed-paediatric-investigation-plan-zoledronic-acid-aclasta-emea-000057-pip01-07-m04_en.pdf"},
    {"id":"26116","name":"P/0164/2012: EMA decision of 23 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for eculizumab (Soliris), (EMEA-000876-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T13:00:00Z","last_updated_date":"2012-10-08T11:50:00Z","reference_number":"EMA/475332/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2012-ema-decision-23-july-2012-agreement-paediatric-investigation-plan-granting-deferral-eculizumab-soliris-emea-000876-pip02-11_en.pdf"},
    {"id":"26133","name":"P/0011/2012: EMA decision of 24 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for lebrikizumab (EMEA-001053-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/32930/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2012-ema-decision-24-january-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lebrikizumab-emea-001053-pip01-10_en.pdf"},
    {"id":"26146","name":"P/0272/2016: EMA decision of 7 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for albiglutide (Eperzan), (EMEA-001175-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585484/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0272-2016-ema-decision-7-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-albiglutide-eperzan-emea-001175-pip01-11-m04_en.pdf"},
    {"id":"26171","name":"P/0147/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/305214/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m11_en.pdf"},
    {"id":"26173","name":"P/268/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Pitavastatin and associated names) (EMEA-000302-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T17:00:00Z","last_updated_date":"2011-11-30T17:00:00Z","reference_number":"EMA/831324/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-268-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-pitavastatin-associated-names-emea-000302-pip01-08-m02_en.pdf"},
    {"id":"26174","name":"P/0274/2014: EMA decision of 28 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation Factor VIII / von Willebrand Factor (Voncento), (EMEA-000312-PIP01-08-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/605305/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0274-2014-ema-decision-28-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-voncento-emea-000312-pip01-08-m07_en.pdf"},
    {"id":"26181","name":"P/0330/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Dactylis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Secale ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/713543/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0330-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-pollen-dactylis-glomerata-lolium-perenne-phleum-pratense-festuca-pratensis-secale_en.pdf"},
    {"id":"26187","name":"P/0204/2014: EMA decision of 8 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vosaroxin (EMEA-001450-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/392207/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2014-ema-decision-8-august-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vosaroxin-emea-001450-pip01-13_en.pdf"},
    {"id":"26198","name":"P/0008/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet hydrochloride (Mimpara), (EMEA-000078-PIP01-07-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1359/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-cinacalcet-hydrochloride-mimpara-emea-000078-pip01-07-m07_en.pdf"},
    {"id":"26224","name":"P/0137/2012: EMA decision of 20 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names), (EMEA-000347-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/452347/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2012-ema-decision-20-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-associated-names-emea-000347-pip01-08-m02_en.pdf"},
    {"id":"26263","name":"P/0206/2012: EMA decision of 17 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for oseltamivir\n\n(phosphate) (Tamiflu), (EMEA-000365-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/538918/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2012-ema-decision-17-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-oseltamivir-phosphate-tamiflu-emea-000365-pip01-08-m04_en.pdf"},
    {"id":"26273","name":"P/127/2010: European Medicines Agency decision of 28 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxa...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/472909/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-127-2010-european-medicines-agency-decision-28-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-n-24-di-tert-butyl-5-hydroxyphenyl-14-dihydro-4-oxoquinoline-3-carboxa_en.pdf"},
    {"id":"26290","name":"P/0208/2013: EMA decision of 3 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for chimaeric anti-disialoganglioside (GD2) monoclonal antibody (NSC764038) (EMEA-001285-PIP01-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/466271/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2013-ema-decision-3-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-chimaeric-anti-disialoganglioside-gd2-monoclonal-antibody-nsc764038-emea-001285-pip01_en.pdf"},
    {"id":"26316","name":"P/0109/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab\n\n(Stelara), (EMEA-000311-PIP03-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/163772/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-ustekinumab-stelara-emea-000311-pip03-11-m02_en.pdf"},
    {"id":"26342","name":"P/38/2008: European medicines agency decision of 24 June 2008\n\non the application for agreement of a Paediatric Investigation Plan for pitavastatin calcium EMEA-000302-PIP01-08 in accordance with Regulation (EC) No 1901/...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/315969/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-38-2008-european-medicines-agency-decision-24-june-2008-application-agreement-paediatric-investigation-plan-pitavastatin-calcium-emea-000302-pip01-08-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"26386","name":"P/272/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for Pneumococcal\n\npolysaccharide serotype 1 conjugated to protein D..(EMEA-000673-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T17:00:00Z","last_updated_date":"2011-11-30T17:00:00Z","reference_number":"EMA/828368/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-272-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-pneumococcal-polysaccharide-serotype-1-conjugated-protein-demea-000673-pip01-09-m03_en.pdf"},
    {"id":"26416","name":"P/0050/2014: European Medicines Agency decision of 7 March 2014 on the agreement of a paediatric investigation plan and on the refusal of a waiver for enalapril (maleate) (EMEA-001241-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/43448/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2014-european-medicines-agency-decision-7-march-2014-agreement-paediatric-investigation-plan-refusal-waiver-enalapril-maleate-emea-001241-pip02-13_en.pdf"},
    {"id":"26446","name":"P/0002/2014: European Medicines Agency decision of 21 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (EMEA-000380-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-17T01:00:00Z","last_updated_date":"2014-02-17T01:00:00Z","reference_number":"EMA/738883/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2014-european-medicines-agency-decision-21-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-secukinumab-emea-000380-pip02-09-m01_en.pdf"},
    {"id":"26455","name":"P/189/2010: European Medicines Agency decision of 27 September 2010 on the granting of a product specific waiver for copper [64 Cu] chloride (EMEA-001002-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/583623/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-189-2010-european-medicines-agency-decision-27-september-2010-granting-product-specific-waiver-copper-64-cu-chloride-emea-001002-pip01-10_en.pdf"},
    {"id":"26466","name":"P/37/2011: EMA decision of 24 January 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for GLP-1 analogue linked to human IgG4 Fc-fragment (LY2189...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-24T01:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/37133/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-37-2011-ema-decision-24-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-glp-1-analogue-linked-human-igg4-fc-fragment-ly2189_en.pdf"},
    {"id":"26471","name":"P/0225/2016: EMA decision of 12 August 2016 on the granting of a product specific waiver for amlodipine / rosuvastatin (EMEA-001935-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/519655/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2016-ema-decision-12-august-2016-granting-product-specific-waiver-amlodipine-rosuvastatin-emea-001935-pip01-16_en.pdf"},
    {"id":"26476","name":"P/0097/2013: EMA decision of 29 April 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zanamivir (Relenza), (EMEA-001318-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201171/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2013-ema-decision-29-april-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-zanamivir-relenza-emea-001318-pip01-12_en.pdf"},
    {"id":"26479","name":"P/152/2011: EMA decision of 30 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for a derivative of\n\noctahydro-4-hydroxy-4-[phenylethynyl]-1H-indole-1-carboxylic acid ester ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-15T02:00:00Z","last_updated_date":"2011-07-15T02:00:00Z","reference_number":"EMA/493240/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-152-2011-ema-decision-30-june-2011-agreement-paediatric-investigation-plan-granting-deferral-derivative-octahydro-4-hydroxy-4-phenylethynyl-1h-indole-1-carboxylic-acid-ester_en.pdf"},
    {"id":"26506","name":"P/0307/2013: EMA decision of 13 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa) (EMEA-000467-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-17T11:00:00Z","last_updated_date":"2014-01-17T11:00:00Z","reference_number":"EMA/698175/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2013-ema-decision-13-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m04_en.pdf"},
    {"id":"26529","name":"P/296/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (Ilaris), (EMEA-000060-PIP02-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/958604/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-296-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-canakinumab-ilaris-emea-000060-pip02-08-m04_en.pdf"},
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    {"id":"26555","name":"P/0083/2014: EMA decision of 4 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium) (Zevtera and associated names), (EMEA-000205-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/113585/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2014-ema-decision-4-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-ceftobiprole-medocaril-sodium-zevtera-associated-names-emea-000205-pip02-11-m01_en.pdf"},
    {"id":"26579","name":"P/0129/2013: EMA decision of 28 May 2013 on the granting of a product-specific waiver for ivabradine (hydrochloride) / metoprolol (tartrate) (EMEA-001405-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/250331/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2013-ema-decision-28-may-2013-granting-product-specific-waiver-ivabradine-hydrochloride-metoprolol-tartrate-emea-001405-pip01-12_en.pdf"},
    {"id":"26582","name":"P/0222/2012: EMA decision of 1 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for ioforminol (EMEA-001197-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/494333/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2012-ema-decision-1-october-2012-agreement-paediatric-investigation-plan-granting-deferral-ioforminol-emea-001197-pip01-11_en.pdf"},
    {"id":"26627","name":"P/0079/2015: EMA decision of 10 April 2015 on the granting of a product-specific waiver for ezetimibe / atorvastatin (calcium trihydrate) (Atozet and associated names, Kexrolt and associated names, Orvatez and associated...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/222887/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2015-ema-decision-10-april-2015-granting-product-specific-waiver-ezetimibe-atorvastatin-calcium-trihydrate-atozet-associated-names-kexrolt-associated-names-orvatez-associated_en.pdf"},
    {"id":"26637","name":"P/0036/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for riociguat (Adempas), (EMEA-000718-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/64978/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-riociguat-adempas-emea-000718-pip01-09-m05_en.pdf"},
    {"id":"26658","name":"P/60/2011: EMA decision of 4 March 2011 on the granting of a product specific waiver for testosterone (EMEA-001026-PIP01-10) in accordance with Regulation (EC) No 1901/2006 of the European Parliament and of the Council","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/78568/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-60-2011-ema-decision-4-march-2011-granting-product-specific-waiver-testosterone-emea-001026-pip01-10-accordance-regulation-ec-no-1901-2006-european-parliament-council_en.pdf"},
    {"id":"26666","name":"P/0325/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant\n\nparathyroid hormone (Natpar), (EMEA-001526-PIP01-13-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-02-16T01:00:00Z","last_updated_date":"2018-02-16T01:00:00Z","reference_number":"EMA/662328/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0325-2017-ema-decision-31-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-parathyroid-hormone-natpar-emea-001526-pip01-13-m02_en.pdf"},
    {"id":"26669","name":"P/0093/2012: EMA decision of 30 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for voclosporin (EMEA-000132-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/304302/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2012-ema-decision-30-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-voclosporin-emea-000132-pip01-07-m03_en.pdf"},
    {"id":"26690","name":"P/0313/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan for complex of povidone and iodine /\n\ndexamethasone (SHP640) (EMEA-001936-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/757980/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0313-2016-ema-decision-21-december-2016-agreement-paediatric-investigation-plan-complex-povidone-iodine-dexamethasone-shp640-emea-001936-pip01-16_en.pdf"},
    {"id":"26692","name":"P/0081/2012: EMA decision of 30 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation factor VIII / von Willebrand Factor (EMEA-000312-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-25T02:00:00Z","last_updated_date":"2012-05-25T02:00:00Z","reference_number":"EMA/269507/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2012-ema-decision-30-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-emea-000312-pip01-08-m03_en.pdf"},
    {"id":"26812","name":"P/0289/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for N. meningitidis serogroup A / C / W / Y polysaccharide conjugated to tetanus toxoid / N.  (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/693022/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0289-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-n-meningitidis-serogroup-c-w-y-polysaccharide-conjugated-tetanus-toxoid-n_en.pdf"},
    {"id":"26828","name":"P/0110/2014: EMA decision of 5 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for drospirenone (EMEA-001495-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-05T02:00:00Z","last_updated_date":"2014-06-05T02:00:00Z","reference_number":"EMA/188327/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2014-ema-decision-5-may-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-drospirenone-emea-001495-pip01-13_en.pdf"},
    {"id":"26848","name":"P/225/2011: EMA decision of 27 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (EMEA-\n\n000916-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/686500/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-225-2011-ema-decision-27-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-lixisenatide-emea-000916-pip01-10-m01_en.pdf"},
    {"id":"26866","name":"P/89/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a waiver for valganciclovir\n\n(Valcyte and associated names), (EMEA-000726-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/193382/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-89-2011-ema-decision-8-april-2011-agreement-paediatric-investigation-plan-granting-waiver-valganciclovir-valcyte-associated-names-emea-000726-pip01-09_en.pdf"},
    {"id":"26878","name":"P/0067/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sarilumab (EMEA-001045-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/113206/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0067-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sarilumab-emea-001045-pip01-10_en.pdf"},
    {"id":"26880","name":"P/0016/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin (EMEA-000828-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/783837/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-empagliflozin-emea-000828-pip01-09-m02_en.pdf"},
    {"id":"26882","name":"P/0267/2016: EMA decision of 5 October 2016 on the granting of a product specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/585779/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2016-ema-decision-5-october-2016-granting-product-specific-waiver-ibuprofen-paracetamol-emea-002002-pip01-16_en.pdf"},
    {"id":"26906","name":"P/0087/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion Influenza A/Vietnam/...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/205459/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0087-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-purified-antigen-fractions-inactivated-split-virion-influenza-vietnam_en.pdf"},
    {"id":"26932","name":"P/0019/2012: EMA decision of 27 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for bevacizumab (Avastin), (EMEA-000056-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/984981/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2012-ema-decision-27-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-bevacizumab-avastin-emea-000056-pip01-07-m01_en.pdf"},
    {"id":"26943","name":"P/88/2011: EMA decision of 8 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for boceprevir (EMEA-000583-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/254196/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-88-2011-ema-decision-8-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-boceprevir-emea-000583-pip01-09-m02_en.pdf"},
    {"id":"26975","name":"P/0160/2013: EMA decision of 8 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mifepristone (EMEA-001292-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-09T16:30:00Z","last_updated_date":"2013-08-09T16:30:00Z","reference_number":"EMA/398270/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2013-ema-decision-8-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mifepristone-emea-001292-pip01-12_en.pdf"},
    {"id":"27003","name":"P/43/2008: European medicines agency decision of 24 June 2008\n\non the application for product specific waiver for vernakalant hydrochloride\n\n(EMEA-000226-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/313727/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-43-2008-european-medicines-agency-decision-24-june-2008-application-product-specific-waiver-vernakalant-hydrochloride-emea-000226-pip01-08-accordance-regulation-ec-no-1901-2006-e_en.pdf"},
    {"id":"27012","name":"P/133/2010:  European Medicines Agency decision of 28 July 2010 on the refusal of a paediatric investigation plan and on the granting of a waiver for omalizumab, (Xolair) (EMEA-000735-PIP01-09) in accordance with Regulat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/463568/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-133-2010-european-medicines-agency-decision-28-july-2010-refusal-paediatric-investigation-plan-granting-waiver-omalizumab-xolair-emea-000735-pip01-09-accordance-regulat_en.pdf"},
    {"id":"27019","name":"P/0214/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human-cell-line\n\nrecombinant human factor VIII (human-cl rhFVIII) / human coagulation fact...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/501506/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-cell-line-recombinant-human-factor-viii-human-cl-rhfviii-human-coagulation-fact_en.pdf"},
    {"id":"27032","name":"P/0100/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ibrutinib (Imbruvica), (EMEA-001397-PIP03-14-M02) CORR","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/202477/2017 corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0100-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-ibrutinib-imbruvica-emea-001397-pip03-14-m02-corr_en.pdf"},
    {"id":"27035","name":"P/0124/2014: EMA decision of 16 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for cobimetinib (EMEA-001425-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-25T02:00:00Z","last_updated_date":"2014-06-25T02:00:00Z","reference_number":"EMA/273992/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2014-ema-decision-16-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-cobimetinib-emea-001425-pip01-13-m01_en.pdf"},
    {"id":"27045","name":"P/155/2009: European Medicines Agency decision of 11 August 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for midazolam hydrochloride (EMEA-000395-PIP01-08 in accordance with Re...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/494800/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-155-2009-european-medicines-agency-decision-11-august-2009-agreement-paediatric-investigation-plan-granting-waiver-midazolam-hydrochloride-emea-000395-pip01-08-accordance-re_en.pdf"},
    {"id":"27055","name":"P/205/2011: EMA decision of 26 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for artemether / lumefantrine (Riamet) (EMEA-000777-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/646448/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-205-2011-ema-decision-26-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-artemether-lumefantrine-riamet-emea-000777-pip01-09-m01_en.pdf"},
    {"id":"27066","name":"P/0127/2012: EMA decision of 4 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for odanacatib (EMEA-001123-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/416710/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2012-ema-decision-4-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-odanacatib-emea-001123-pip01-11_en.pdf"},
    {"id":"27089","name":"P/0142/2016: EMA decision of 20 May 2016 on the granting of a product specific waiver for diclofenac (sodium) / capsaicin (EMEA-001861-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/290708/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2016-ema-decision-20-may-2016-granting-product-specific-waiver-diclofenac-sodium-capsaicin-emea-001861-pip01-15_en.pdf"},
    {"id":"27095","name":"P/0099/2012: EMA decision of 30 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine (hydrochloride) (Procoralan) (EMEA-000628-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/274366/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0099-2012-ema-decision-30-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-procoralan-emea-000628-pip01-09-m03_en.pdf"},
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    {"id":"27150","name":"P/0113/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin\n\n(Xydalba), (EMEA-000016-PIP01-07-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/190072/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-dalbavancin-xydalba-emea-000016-pip01-07-m06_en.pdf"},
    {"id":"27153","name":"P/0281/2012: EMA decision of 21 November 2012 on the granting of a product-specific waiver for brimonidine tartrate (EMEA-001239-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-07T01:00:00Z","last_updated_date":"2013-01-07T01:00:00Z","reference_number":"EMA/725996/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0281-2012-ema-decision-21-november-2012-granting-product-specific-waiver-brimonidine-tartrate-emea-001239-pip01-11_en.pdf"},
    {"id":"27184","name":"P/0263/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/592124/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0263-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m08_en.pdf"},
    {"id":"27188","name":"P/0063/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for veliparib (EMEA-000499-PIP04-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/105839/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2018-ema-decision-16-march-2018-granting-product-specific-waiver-veliparib-emea-000499-pip04-17_en.pdf"},
    {"id":"27190","name":"P/0099/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for raltegravir (Isentress), (EMEA-000279-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/206647/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0099-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-raltegravir-isentress-emea-000279-pip01-08-m01_en.pdf"},
    {"id":"27206","name":"P/0240/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam\n\n(Briviact), (EMEA-000332-PIP01-08-M12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-29T02:00:00Z","last_updated_date":"2017-09-29T02:00:00Z","reference_number":"EMA/506967/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0240-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-briviact-emea-000332-pip01-08-m12_en.pdf"},
    {"id":"27217","name":"P/0179/2017: EMA decision of 3 July 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for larotrectinib (EMEA-001971-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/382606/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0179-2017-ema-decision-3-july-2017-agreement-paediatric-investigation-plan-granting-deferral-larotrectinib-emea-001971-pip02-16_en.pdf"},
    {"id":"27224","name":"P/0279/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Dactylis glomarata, Lolium perenne, Phleum pratense, Poa pratensis, Anthoxhantu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/690862/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0279-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-pollen-dactylis-glomarata-lolium-perenne-phleum-pratense-poa-pratensis-anthoxhantu_en.pdf"},
    {"id":"27240","name":"P/0022/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for upadacitinib (ABT-494) (EMEA-001741-PIP02-16)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/29956/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2018-ema-decision-30-january-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-upadacitinib-abt-494-emea-001741-pip02-16_en.pdf"},
    {"id":"27270","name":"P/132/2009: European Medicines Agency decision of 17 July 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for recombinant human C1 inhibitor (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/352210/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-132-2009-european-medicines-agency-decision-17-july-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-c1-inhibitor-eme_en.pdf"},
    {"id":"27344","name":"P/0257/2012: EMA decision of 26 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tofacitinib (citrate) (EMEA-000576-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/677853/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0257-2012-ema-decision-26-october-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tofacitinib-citrate-emea-000576-pip02-11_en.pdf"},
    {"id":"27384","name":"P/0014/2018: EMA decision of 30 January 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for chloroprocaine (hydrochloride) (Ampres), (EMEA-000639-PIP03-16)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T02:00:00Z","last_updated_date":"2018-04-17T02:00:00Z","reference_number":"EMA/850788/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2018-ema-decision-30-january-2018-agreement-paediatric-investigation-plan-granting-deferral-chloroprocaine-hydrochloride-ampres-emea-000639-pip03-16_en.pdf"},
    {"id":"27391","name":"P/0241/2017: EMA decision of 4 September 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for lefamulin\n\n(EMEA-002075-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/507360/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0241-2017-ema-decision-4-september-2017-agreement-paediatric-investigation-plan-granting-deferral-lefamulin-emea-002075-pip01-16_en.pdf"},
    {"id":"27402","name":"P/0084/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet hydrochloride (Mimpara), (EMEA-000078-PIP01-07-M06)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/215072/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-cinacalcet-hydrochloride-mimpara-emea-000078-pip01-07-m06_en.pdf"},
    {"id":"27404","name":"P/70/2008: European medicines agency decision of 20 August 2008\n\non the application for agreement of a Paediatric Investigation Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000064-PIP01-07), in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/431839/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-70-2008-european-medicines-agency-decision-20-august-2008-application-agreement-paediatric-investigation-plan-nicotinic-acid-simvastatin-laropiprant-emea-000064-pip01-07-accordance-w_en.pdf"},
    {"id":"27427","name":"P/245/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aluminium hydroxide adsorbed, depigmented glutaraldeh...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/672975/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-245-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaraldeh_en.pdf"},
    {"id":"27432","name":"P/0073/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for guselkumab (EMEA-001523-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/138342/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-guselkumab-emea-001523-pip02-14_en.pdf"},
    {"id":"27444","name":"P/0002/2016: EMA decision of 14 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP01-07-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/866032/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2016-ema-decision-14-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip01-07-m06_en.pdf"},
    {"id":"27465","name":"P/0324/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for zoledronic acid (monohydrate) (in combination with calcium (carbonate) / cholecalciferol) (EMEA-001689-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/759442/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0324-2014-ema-decision-19-december-2014-granting-product-specific-waiver-zoledronic-acid-monohydrate-combination-calcium-carbonate-cholecalciferol-emea-001689-pip01-14_en.pdf"},
    {"id":"27480","name":"P/60/2009: European Medicines Agency decision of 27 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for nilotinib (Tasigna) (EMEA-000290-PI...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/161203/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-60-2009-european-medicines-agency-decision-27-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-nilotinib-tasigna-emea-000290-pi_en.pdf"},
    {"id":"27482","name":"P/266/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Alipza and associated names) (EMEA-000300-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/831320/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-266-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-alipza-associated-names-emea-000300-pip01-08-m02_en.pdf"},
    {"id":"27490","name":"P/0234/2015: EMA decision of 27 October 2015 on the granting of a product-specific waiver for ciclosporin (EMEA-001007-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-17T01:00:00Z","last_updated_date":"2015-12-17T01:00:00Z","reference_number":"EMA/619832/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2015-ema-decision-27-october-2015-granting-product-specific-waiver-ciclosporin-emea-001007-pip02-15_en.pdf"},
    {"id":"27491","name":"P/233/2010: EMA decision of 26 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for clopidogrel (Plavix) (EMEA-000049-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/706562/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-233-2010-ema-decision-26-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-clopidogrel-plavix-emea-000049-pip01-07-m03_en.pdf"},
    {"id":"27506","name":"P/0290/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (EMEA-000454-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/647795/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0290-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000454-pip01-08-m03_en.pdf"},
    {"id":"27518","name":"P/0071/2012: EMA decision of 24 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for doripenem (monohydrate) (Doribax), (EMEA-000015-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/202883/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2012-ema-decision-24-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-doripenem-monohydrate-doribax-emea-000015-pip01-07-m04_en.pdf"},
    {"id":"27550","name":"P/0216/2017: EMA decision of 9 August 2017 on the granting of a product specific waiver for empagliflozin (Jardiance), (EMEA-000828-PIP05-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/431236/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2017-ema-decision-9-august-2017-granting-product-specific-waiver-empagliflozin-jardiance-emea-000828-pip05-17_en.pdf"},
    {"id":"27554","name":"P/130/2011: EMA decision of 8 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 1-[2-(2,4-dimethyl-phenylsulfanyl)phenyl]piperazine (Lu AA...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/419326/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-130-2011-ema-decision-8-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-1-2-24-dimethyl-phenylsulfanylphenylpiperazine-lu-aa_en.pdf"},
    {"id":"27585","name":"P/0235/2017: EMA decision of 9 August 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for venetoclax (Venclyxto), (EMEA-002018-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/434825/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2017-ema-decision-9-august-2017-agreement-paediatric-investigation-plan-granting-deferral-venetoclax-venclyxto-emea-002018-pip02-16_en.pdf"},
    {"id":"27598","name":"P/0081/2013: European medicines agency decision of 27 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (Trobalt), (EMEA-000116-PIP01-07-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/102701/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2013-european-medicines-agency-decision-27-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-retigabine-trobalt-emea-000116-pip01-07-m06_en.pdf"},
    {"id":"27610","name":"P/0184/2012: EMA decision of 21 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for indacaterol (acetate) / mometasone (furoate) (EMEA-001...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T02:00:00Z","last_updated_date":"2012-09-18T02:00:00Z","reference_number":"EMA/472512/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2012-ema-decision-21-august-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-indacaterol-acetate-mometasone-furoate-emea-001_en.pdf"},
    {"id":"27619","name":"P/0331/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for deferiprone (EMEA-001126-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/761533/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0331-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-deferiprone-emea-001126-pip01-10-m01_en.pdf"},
    {"id":"27656","name":"P/0227/2014: EMA decision of 5 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aliskiren (Rasilez and associated names), (EMEA-000362-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/501292/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2014-ema-decision-5-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-aliskiren-rasilez-associated-names-emea-000362-pip01-08-m04_en.pdf"},
    {"id":"27658","name":"P/0305/2012:EMA decision of 20 December 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for human normal immunoglobulin (LFB-IgSC), (EMEA-001290-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T12:40:00Z","last_updated_date":"2013-02-11T12:40:00Z","reference_number":"EMA/755990/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0305-2012ema-decision-20-december-2012-agreement-paediatric-investigation-plan-granting-waiver-human-normal-immunoglobulin-lfb-igsc-emea-001290-pip01-12_en.pdf"},
    {"id":"27668","name":"P/0188/2013: EMA decision of 8 August 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for naltrexone (hydrochloride) / bupropion (hydrochloride)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-09T17:00:00Z","last_updated_date":"2013-09-09T17:00:00Z","reference_number":"EMA/473174/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0188-2013-ema-decision-8-august-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-naltrexone-hydrochloride-bupropion-hydrochloride_en.pdf"},
    {"id":"27681","name":"P/284/2011: EMA decision of 30 November 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iron (III)-oxyhydroxide (EMEA-001061-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T12:15:00Z","last_updated_date":"2011-12-21T12:15:00Z","reference_number":"EMA/910410/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-284-2011-ema-decision-30-november-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-iron-iii-oxyhydroxide-emea-001061-pip01-10_en.pdf"},
    {"id":"27696","name":"P/0013/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/34937/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-neisseria-meningitidis-serogroup-b-recombinant-lipoprotein-rlp2086-subfamily-escherichi_en.pdf"},
    {"id":"27697","name":"P/0077/2014: EMA decision of 2 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion protein consisting of human coagulation factor VIII attached to the Fc domai...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-15T02:00:00Z","last_updated_date":"2014-05-15T02:00:00Z","reference_number":"EMA/123330/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2014-ema-decision-2-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-consisting-human-coagulation-factor-viii-attached-fc-domai_en.pdf"},
    {"id":"27698","name":"P/0106/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for potassium citrate monohydrated / potassium hydrogen carbonate (EMEA-001357-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/199537/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2016-ema-decision-15-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-potassium-citrate-monohydrated-potassium-hydrogen-carbonate-emea-001357-pip01-12-m01_en.pdf"},
    {"id":"27702","name":"P/0067/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the huma...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/107503/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0067-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-encoding-huma_en.pdf"},
    {"id":"27718","name":"P/92/2009: European medicines agency decision of 18 May 2009 on the granting of a product specific waiver for simvastatin / fenofibrate (EMEA-000490-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Europe...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/280391/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-92-2009-european-medicines-agency-decision-18-may-2009-granting-product-specific-waiver-simvastatin-fenofibrate-emea-000490-pip01-08-accordance-regulation-ec-no-1901-2006-europe_en.pdf"},
    {"id":"27731","name":"P/78/2010: European Medicines Agency decision of 7 May 2010\n\non the granting of a product specific waiver for mometasone furoate (Nasonex and associated names) (EMEA-000351-PIP01-08) in accordance with Regulation (EC) No...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/236423/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-78-2010-european-medicines-agency-decision-7-may-2010-granting-product-specific-waiver-mometasone-furoate-nasonex-associated-names-emea-000351-pip01-08-accordance-regulation-ec-no_en.pdf"},
    {"id":"27759","name":"P/220/2011: EMA decision of 30 September 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for loxapine (EMEA-001115-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/692206/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-220-2011-ema-decision-30-september-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-loxapine-emea-001115-pip01-10_en.pdf"},
    {"id":"27764","name":"P/0085/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for rolapitant (Varuby),\n\n(EMEA-001768-PIP02-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/75565/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0085-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-rolapitant-varuby-emea-001768-pip02-15-m01_en.pdf"},
    {"id":"27775","name":"P/0187/2016: EMA decision of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for landiolol\n\n(hydrochloride) (EMEA-001150-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/408654/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-landiolol-hydrochloride-emea-001150-pip02-13-m01_en.pdf"},
    {"id":"27785","name":"P/0081/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for (2R,3R,4R,5R)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-2-(chloromethyl)-4-fluoro-2-((isobuty...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/104855/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-deferral-2r3r4r5r-5-4-amino-2-oxopyrimidin-12h-yl-2-chloromethyl-4-fluoro-2-isobuty_en.pdf"},
    {"id":"27790","name":"P/0028/2014: European Medicines Agency decision of 27 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate) (EMEA-000788-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/36012/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2014-european-medicines-agency-decision-27-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-edoxaban-tosylate-emea-000788-pip02-11-m02_en.pdf"},
    {"id":"27815","name":"P/0069/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (EMEA-001220-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/113253/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0069-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-baricitinib-emea-001220-pip01-11_en.pdf"},
    {"id":"27823","name":"P/0151/2015: EMA decision of 10 July 2015 on the granting of a product specific waiver for atorvastatin / perindopril / acetylsalicylic acid (EMEA-001547-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/382964/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2015-ema-decision-10-july-2015-granting-product-specific-waiver-atorvastatin-perindopril-acetylsalicylic-acid-emea-001547-pip01-13_en.pdf"},
    {"id":"27869","name":"P/289/2011: EMA decision of 2 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid\n\n(Aclasta) (EMEA-000057-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/915429/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-289-2011-ema-decision-2-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-zoledronic-acid-aclasta-emea-000057-pip01-07-m03_en.pdf"},
    {"id":"27870","name":"P/0329/2014: EMA decision of 11 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for nonacog beta pegol (EMEA-000731-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/713546/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0329-2014-ema-decision-11-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-nonacog-beta-pegol-emea-000731-pip01-09-m02_en.pdf"},
    {"id":"27883","name":"P/0212/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/603314/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-invokana-emea-001030-pip01-10-m04_en.pdf"},
    {"id":"27920","name":"P/0032/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for mirvetuximab soravtansine (EMEA-001921-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/12265/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2017-european-medicines-agency-decision-31-january-2017-granting-product-specific-waiver-mirvetuximab-soravtansine-emea-001921-pip01-16_en.pdf"},
    {"id":"27928","name":"P/91/2009: European medicines agency decision of 18 May 2009 on the refusal of a product specific waiver for rubidium-82 (EMEA-000488-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliament a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/294264/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-91-2009-european-medicines-agency-decision-18-may-2009-refusal-product-specific-waiver-rubidium-82-emea-000488-pip01-08-accordance-regulation-ec-no-1901-2006-european-parliament_en.pdf"},
    {"id":"27929","name":"P/0078/2012: EMA decision of 27 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis),\n\n(EMEA-000183-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/2239/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2012-ema-decision-27-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip01-08-m02_en.pdf"},
    {"id":"27958","name":"P/0264/2017: EMA decision of 4 September 2017 on the granting of a product-specific waiver for daratumumab (Darzalex), (EMEA-002152-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/552272/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0264-2017-ema-decision-4-september-2017-granting-product-specific-waiver-daratumumab-darzalex-emea-002152-pip02-17_en.pdf"},
    {"id":"27972","name":"P/0098/2015: EMA decision of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydrox...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/215117/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0098-2015-ema-decision-8-may-2015-agreement-paediatric-investigation-plan-granting-deferral-1-22-difluoro-13-benzodioxol-5-yl-n-1-2r-23-dihydroxypropyl-6-fluoro-2-1-hydrox_en.pdf"},
    {"id":"27974","name":"P/186/2009: Agreement of a PIP, granting of a deferral and a waiver for N. meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/525904/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-186-2009-agreement-pip-granting-deferral-waiver-n-meningitidis-serogroup-polysaccharide-conjugated-tetanus-toxoid-n-meningitidis-serogroup-c-polysaccharide-conjugated-tetanus-toxoid_en.pdf"},
    {"id":"27999","name":"P/0208/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for anidulafungin\n\n(Ecalta), (EMEA-000469-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/513327/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-anidulafungin-ecalta-emea-000469-pip01-08-m06_en.pdf"},
    {"id":"28008","name":"P/0202/2017: EMA decision of 9 August 2017 on the refusal of a paediatric investigation plan and on the granting of waiver for methacholine chloride\n\n(EMEA-002120-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/460836/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0202-2017-ema-decision-9-august-2017-refusal-paediatric-investigation-plan-granting-waiver-methacholine-chloride-emea-002120-pip01-17_en.pdf"},
    {"id":"28021","name":"P/0033/2012: EMA decision of 3 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate (Pradaxa) (EMEA-000081-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/64914/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2012-ema-decision-3-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-pradaxa-emea-000081-pip01-07-m04_en.pdf"},
    {"id":"28039","name":"P/0047/2013: EMA decision of 1 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for talimogene laherparepvec (EMEA-001251-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/120181/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0047-2013-ema-decision-1-march-2013-agreement-paediatric-investigation-plan-granting-deferral-talimogene-laherparepvec-emea-001251-pip01-11_en.pdf"},
    {"id":"28042","name":"P/0069/2017: EMA decision of 3 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab\n\n(EMEA-001501-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/120432/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0069-2017-ema-decision-3-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-emea-001501-pip01-13-m04_en.pdf"},
    {"id":"28046","name":"P/0014/2013: EMA decision of 23 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ferumoxytol (Rienso) (EMEA-000373-PIP02-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/22310/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2013-ema-decision-23-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-ferumoxytol-rienso-emea-000373-pip02-09-m03_en.pdf"},
    {"id":"28047","name":"P/0254/2015: EMA decision of 30 October 2015 on the granting of a paediatric investigation plan and on the deferral and on the granting of a waiver for simtuzumab (EMEA-001511-PIP03-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T01:00:00Z","last_updated_date":"2015-12-21T01:00:00Z","reference_number":"EMA/627050/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0254-2015-ema-decision-30-october-2015-granting-paediatric-investigation-plan-deferral-granting-waiver-simtuzumab-emea-001511-pip03-14_en.pdf"},
    {"id":"28073","name":"P/306/2011: EMA decision of 20 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for lomitapide (EMEA-001124-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/941395/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-306-2011-ema-decision-20-december-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lomitapide-emea-001124-pip01-10_en.pdf"},
    {"id":"28111","name":"P/194/2010: European medicines agency decision of of 26 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for tiotropium bromide (monohydrate) (Spiriva Respimat and associated na...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/646432/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-194-2010-european-medicines-agency-decision-26-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-tiotropium-bromide-monohydrate-spiriva-respimat-associated-na_en.pdf"},
    {"id":"28123","name":"P/0157/2013: EMA decision of 8 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mifepristone (EMEA-001292-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-13T17:30:00Z","last_updated_date":"2013-08-13T17:30:00Z","reference_number":"EMA/332108/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2013-ema-decision-8-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mifepristone-emea-001292-pip01-12_en.pdf"},
    {"id":"28132","name":"P/263/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Livazo and associated names) (EMEA-000054-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/831326/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-263-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-livazo-associated-names-emea-000054-pip01-07-m02_en.pdf"},
    {"id":"28159","name":"P/0012/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for simeprevir (EMEA-000625-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/10917/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-simeprevir-emea-000625-pip01-09-m02_en.pdf"},
    {"id":"28171","name":"P/0046/2014: EMA decision of 7 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (EMEA-000498-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/43440/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2014-ema-decision-7-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-emea-000498-pip01-08-m02_en.pdf"},
    {"id":"28174","name":"P/195/201: EMA decision of 29 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000167-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/553360/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-195-201-ema-decision-29-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000167-pip01-07-m02_en.pdf"},
    {"id":"28202","name":"P/304/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for Pollen from Phleum pratense (EMEA-000867-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/778412/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-304-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-phleum-pratense-emea-000867-pip01-10_en.pdf"},
    {"id":"28205","name":"P/210/2009: European Medicines Agency decision of 30 October 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for methoxyflurane (EMEA-000334-PIP0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/604416/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-210-2009-european-medicines-agency-decision-30-october-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-methoxyflurane-emea-000334-pip0_en.pdf"},
    {"id":"28214","name":"P/318/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of rye pollen (EMEA-000943-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769453/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-318-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-rye-pollen-emea-000943_en.pdf"},
    {"id":"28217","name":"P/305/2011: EMA decision of 20 December 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human monoclonal antibody against IL-6 (CNTO 136), (E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/792730/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-305-2011-ema-decision-20-december-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-monoclonal-antibody-against-il-6-cnto-136-e_en.pdf"},
    {"id":"28295","name":"P/0091/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for anidulafungin (Ecalta), (EMEA-000469-PIP01-08-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/205463/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-anidulafungin-ecalta-emea-000469-pip01-08-m05_en.pdf"},
    {"id":"28301","name":"P/0155/2014: EMA decision of 16 June 2014 on the refusal of a paediatric investigation plan and on the granting of a waiver and on the granting of a waiver ex officio for freeze-dried culture of Lactobacillus casei subsp...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/252168/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2014-ema-decision-16-june-2014-refusal-paediatric-investigation-plan-granting-waiver-granting-waiver-ex-officio-freeze-dried-culture-lactobacillus-casei-subsp_en.pdf"},
    {"id":"28322","name":"P/96/2008: European medicines agency decision of 3 November 2008\n\non the application for agreement of a Paediatric Investigation Plan for paracetamol (EMEA-000130-PIP01-07) in accordance with Regulation (EC) No 1901/2006...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-07T00:00:00Z","last_updated_date":"2009-01-07T00:00:00Z","reference_number":"EMEA/570616/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-96-2008-european-medicines-agency-decision-3-november-2008-application-agreement-paediatric-investigation-plan-paracetamol-emea-000130-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"28329","name":"P/0286/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for peanut allergen extract (EMEA-001481-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/766272/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0286-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-peanut-allergen-extract-emea-001481-pip01-13-m01_en.pdf"},
    {"id":"28353","name":"P/172/2009: European Medicines Agency decision of 28 August 2009 on the granting of a product specific waiver for sitagliptin phosphate monohydrate / simvastatin (EMEA-000538-PIP01-09) in accordance with Regulation (EC) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/531555/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-172-2009-european-medicines-agency-decision-28-august-2009-granting-product-specific-waiver-sitagliptin-phosphate-monohydrate-simvastatin-emea-000538-pip01-09-accordance-regulation-ec_en.pdf"},
    {"id":"28360","name":"P/88/2009: European medicines agency decision of 18 May 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for bilastine (EMEA-000347-PIP01-08) in a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/272633/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-88-2009-european-medicines-agency-decision-18-may-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bilastine-emea-000347-pip01-08_en.pdf"},
    {"id":"28375","name":"P/0034/2016: EMA decision of 29 January 2016 on the granting of a product specific waiver for (3Z,5S)-5-(hydroxymethyl)-1-[(2'-methyl[1,1'-biphenyl]-4-yl)-carbonyl]-3-pyrrolidinone-O-methyloxime (EMEA-001854-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/2823/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2016-ema-decision-29-january-2016-granting-product-specific-waiver-3z5s-5-hydroxymethyl-1-2-methyl11-biphenyl-4-yl-carbonyl-3-pyrrolidinone-o-methyloxime-emea-001854-pip01-15_en.pdf"},
    {"id":"28449","name":"P/177/2009: European Medicines Agency decision of 7 September 2009\n\non the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for 6,7-dihydro-5H-pyrrolo[1,2-c] ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/516800/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-177-2009-european-medicines-agency-decision-7-september-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-67-dihydro-5h-pyrrolo12-c_en.pdf"},
    {"id":"28460","name":"P/0154/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Saxenda)\n\n(EMEA-000128-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/380505/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-saxenda-emea-000128-pip02-09-m02_en.pdf"},
    {"id":"28465","name":"P/0164/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ferric maltol (Feraccru), (EMEA-001195-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/348022/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2017-ema-decision-3-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-ferric-maltol-feraccru-emea-001195-pip01-11-m03_en.pdf"},
    {"id":"28477","name":"P/0198/2017: EMA decision of 14 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (Orkambi), (EMEA-001582-PIP01-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/433402/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2017-ema-decision-14-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-lumacaftor-ivacaftor-orkambi-emea-001582-pip01-13-m06_en.pdf"},
    {"id":"28504","name":"P/0114/2013: EMA decision of 26 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names), (EMEA-000573-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/247143/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0114-2013-ema-decision-26-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip01-09-m03_en.pdf"},
    {"id":"28533","name":"P/236/2009: European Medicines Agency Decision of 27 November 2009 on the granting of a product specific waiver for aliskiren hemifumarate / amlodipine besilate / hydrochlorothiazide (EMEA-000656-PIP01-09) in accordance ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:09:21Z","last_updated_date":"2009-12-23T00:09:21Z","reference_number":"EMEA/748101/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-236-2009-european-medicines-agency-decision-27-november-2009-granting-product-specific-waiver-aliskiren-hemifumarate-amlodipine-besilate-hydrochlorothiazide-emea-000656-pip01-09-accordance_en.pdf"},
    {"id":"28535","name":"P/0102/2014: EMA decision of 2 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for corifollitropin alfa (Elonva) (EMEA-000306-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-11T16:00:00Z","last_updated_date":"2014-06-11T16:00:00Z","reference_number":"EMA/232938/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2014-ema-decision-2-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-corifollitropin-alfa-elonva-emea-000306-pip01-08-m02_en.pdf"},
    {"id":"28548","name":"P/70/2011: EMA decision of 4 April 2011 on the granting of a product specific waiver for amlodipine besilate / perindopril tert-butylamine\n\n(EMEA-000823-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/212712/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-70-2011-ema-decision-4-april-2011-granting-product-specific-waiver-amlodipine-besilate-perindopril-tert-butylamine-emea-000823-pip02-10_en.pdf"},
    {"id":"28564","name":"P/0226/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium\n\ncyclosilicate (EMEA-001539-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/459236/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-sodium-zirconium-cyclosilicate-emea-001539-pip01-13-m02_en.pdf"},
    {"id":"28588","name":"P/0132/2013: EMA decision of 31 May 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for lacosamide (Vimpat) (EMEA-000402-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/317063/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2013-ema-decision-31-may-2013-agreement-paediatric-investigation-plan-granting-deferral-lacosamide-vimpat-emea-000402-pip02-11_en.pdf"},
    {"id":"28589","name":"P/0361/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio)\n\n(EMEA-001849-PIP02-15-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T16:03:00Z","last_updated_date":"2018-03-02T16:03:00Z","reference_number":"EMA/709765/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0361-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-avelumab-bavencio-emea-001849-pip02-15-m01_en.pdf"},
    {"id":"28596","name":"P/0211/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Xgeva (previously Amgiva), Prolia) (EMEA-000145-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/611454/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-xgeva-previously-amgiva-prolia-emea-000145-pip01-07-m05_en.pdf"},
    {"id":"28606","name":"P/0103/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for pixantrone (dimaleate) (Pixuvri), (EMEA-000713-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/187577/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-pixantrone-dimaleate-pixuvri-emea-000713-pip02-10-m02_en.pdf"},
    {"id":"28619","name":"P/0072/2012: EMA decision of 24 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (EMEA-000769-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/202840/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2012-ema-decision-24-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-emea-000769-pip01-09-m02_en.pdf"},
    {"id":"28631","name":"P/0241/2014: EMA decision of 29 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate (Pradaxa), (EMEA-000081-PIP01-07-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/527083/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0241-2014-ema-decision-29-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-pradaxa-emea-000081-pip01-07-m07_en.pdf"},
    {"id":"28636","name":"P/0046/2018: EMA decision of 16 February 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for upadacitinib (ABT-494) (EMEA-001741-PIP03-16)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/85849/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2018-ema-decision-16-february-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-upadacitinib-abt-494-emea-001741-pip03-16_en.pdf"},
    {"id":"28653","name":"P/29/2008: European medicines agency decision of 23 May 2008 on the application for product specific waiver for arzoxifene (EMEA-000179-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of the European Parliament...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-17T02:00:00Z","last_updated_date":"2008-07-17T02:00:00Z","reference_number":"EMEA/259255/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-29-2008-european-medicines-agency-decision-23-may-2008-application-product-specific-waiver-arzoxifene-emea-000179-pip01-07-accordance-regulation-ec-no-1901-2006-european-parliament_en.pdf"},
    {"id":"28660","name":"P/0362/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lumicitabine (EMEA-\n\n001758-PIP01-15-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T13:05:00Z","last_updated_date":"2018-03-02T13:05:00Z","reference_number":"EMA/762994/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0362-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-lumicitabine-emea-001758-pip01-15-m02_en.pdf"},
    {"id":"28682","name":"P/0283/2012: EMA decision of 23 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for bosentan (Tracleer),\n\n(EMEA-000425-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/493954/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0283-2012-ema-decision-23-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-bosentan-tracleer-emea-000425-pip02-10-m03_en.pdf"},
    {"id":"28714","name":"P/0268/2016: EMA decision of 7 October 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for guadecitabine (EMEA-001730-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/632890/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2016-ema-decision-7-october-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-guadecitabine-emea-001730-pip02-15_en.pdf"},
    {"id":"28730","name":"P/310/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir (EMEA-000968-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/693832/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-310-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-emea-000968-pip02-11-m03_en.pdf"},
    {"id":"28735","name":"P/0013/2013: EMA decision of 23 January 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for apixaban (Eliquis) (EMEA-000183-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T14:30:00Z","last_updated_date":"2013-04-03T14:30:00Z","reference_number":"EMA/28382/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2013-ema-decision-23-january-2013-agreement-paediatric-investigation-plan-granting-deferral-apixaban-eliquis-emea-000183-pip02-12_en.pdf"},
    {"id":"28744","name":"P/0255/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for alogliptin (Vipidia),\n\n(EMEA-000496-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585768/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0255-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-alogliptin-vipidia-emea-000496-pip01-08-m05_en.pdf"},
    {"id":"28750","name":"P/0158/2015: EMA decision of 10 July 2015 on the granting of a product specific waiver for clonidine (EMEA-001746-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/366856/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2015-ema-decision-10-july-2015-granting-product-specific-waiver-clonidine-emea-001746-pip01-15_en.pdf"},
    {"id":"28758","name":"P/135/2010:  European Medicines Agency decision of 28 July 2010 on the granting of a product specific waiver for levonorgestrel/ethinylestradiol (EMEA-000829-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/463871/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-135-2010-european-medicines-agency-decision-28-july-2010-granting-product-specific-waiver-levonorgestrel-ethinylestradiol-emea-000829-pip01-09-accordance-regulation-ec-no-1901-2006-t_en.pdf"},
    {"id":"28773","name":"P/0303/2017: EMA decision of 9 November 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the refusal of a\n\nwaiver for 1H-Isoindol-1-one,2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/735836/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0303-2017-ema-decision-9-november-2017-refusal-paediatric-investigation-plan-refusal-deferral-refusal-waiver-1h-isoindol-1-one2-1-2-4-fluorophenyl-2-oxoethyl_en.pdf"},
    {"id":"28790","name":"P/0187/2012: EMA decision of 21 August 2012 on the granting of a product specific waiver for [N-\n\n((2S,3R,3aS,3´R,4a´R,6S,6a´R,6b´S,7aR,12a´S,12b´S,Z)-3,6,11´,12b´-tetramethyl-\n\n2´,3a,3´,4,4´,4a´,5,5´,6,6´,6a´,6b´,7,7a,7...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T02:00:00Z","last_updated_date":"2012-09-18T02:00:00Z","reference_number":"EMA/528778/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2012-ema-decision-21-august-2012-granting-product-specific-waiver-n-2s3r3as3r4ar6s6ar6bs7ar12as12bsz-361112b-tetramethyl-23a3444a55666a6b77a7_en.pdf"},
    {"id":"28800","name":"P/229/2010: EMA decision of 23 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for rosuvastatin (calcium) (Crestor and associated names) (EMEA-000022-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T00:09:21Z","last_updated_date":"2010-12-21T00:09:21Z","reference_number":"EMA/714398/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-229-2010-ema-decision-23-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-rosuvastatin-calcium-crestor-associated-names-emea-000022-pip01-07-m04_en.pdf"},
    {"id":"28805","name":"P/218/2009: European Medicines Agency decision of 30 October 2009 on the refusal of a product specific waiver for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerized, allergenic extract of birch, alder a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/679781/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-218-2009-european-medicines-agency-decision-30-october-2009-refusal-product-specific-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerized-allergenic-extract-birch-alder_en.pdf"},
    {"id":"28808","name":"P/0278/2012: EMA decision of 21 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for brentuximab vedotin\n\n(EMEA-000980-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/725347/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0278-2012-ema-decision-21-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-brentuximab-vedotin-emea-000980-pip01-10-m01_en.pdf"},
    {"id":"28815","name":"P/0266/2017: EMA decision of 4 September 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous T cells transduced with lentiviral vector...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/496518/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2017-ema-decision-4-september-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-t-cells-transduced-lentiviral-vector_en.pdf"},
    {"id":"28841","name":"P/0193/2013: EMA decision of 13 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for rupadatine fumarate (Rupafin and associated names) (EMEA-000582-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-09T18:45:00Z","last_updated_date":"2013-09-09T18:45:00Z","reference_number":"EMA/449238/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2013-ema-decision-13-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-rupadatine-fumarate-rupafin-associated-names-emea-000582-pip01-09-m02_en.pdf"},
    {"id":"28860","name":"P/176/2011: EMA decision of 8 July 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for gadobutrol (Gadovist) (EMEA-000994-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/513777/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-176-2011-ema-decision-8-july-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-gadobutrol-gadovist-emea-000994-pip01-10_en.pdf"},
    {"id":"28874","name":"P/138/2010: European Medicines Agency decision of 30 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir (Prezista), (EMEA-000038-PIP01-07-M03) in accordance with Regula...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/463333/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-138-2010-european-medicines-agency-decision-30-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-darunavir-prezista-emea-000038-pip01-07-m03-accordance-regula_en.pdf"},
    {"id":"28876","name":"P/0071/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for evolocumab (EMEA-001268-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/108903/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-evolocumab-emea-001268-pip01-12-m01_en.pdf"},
    {"id":"28922","name":"P/0001/2016: EMA decision of 8 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for PEGylated recombinant factor VIII (EMEA-001296-PIP01-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/866072/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2016-ema-decision-8-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-pegylated-recombinant-factor-viii-emea-001296-pip01-12-m03_en.pdf"},
    {"id":"28957","name":"P/0012/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate)\n\n(Lixiana), (EMEA-000788-PIP02-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/34675/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-edoxaban-tosylate-lixiana-emea-000788-pip02-11-m05_en.pdf"},
    {"id":"28958","name":"P/0187/2014: EMA decision of 6 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for riociguat (ADEMPAS), (EMEA-000718-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/409208/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2014-ema-decision-6-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-riociguat-adempas-emea-000718-pip01-09-m04_en.pdf"},
    {"id":"28995","name":"P/72/2011: EMA decision of 4 April 2011 on the granting of a product-specific waiver for [18F]flutemetamol (EMEA-001028-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2012-12-11T18:00:03Z","reference_number":"EMA/206028/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-72-2011-ema-decision-4-april-2011-granting-product-specific-waiver-18fflutemetamol-emea-001028-pip01-10_en.pdf"},
    {"id":"28997","name":"P/0238/2013: EMA decision of 24 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for insulin peglispro, (EMEA-001097-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/566317/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0238-2013-ema-decision-24-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-insulin-peglispro-emea-001097-pip01-10-m01_en.pdf"},
    {"id":"29002","name":"P/04/2009: European Medicines Agency decision of 27 January 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for mometasone furoate, formoterol fumarate dihydrate (EMEA-000025-PIP01-07-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/24357/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-04-2009-european-medicines-agency-decision-27-january-2009-acceptance-modification-agreed-paediatric-investigation-plan-mometasone-furoate-formoterol-fumarate-dihydrate-emea-000025-pip01-07_en.pdf"},
    {"id":"29003","name":"P/0029/2014: European Medicines Agency decision of 13 February 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for clazakizumab (EMEA-001371-PIP0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-03-20T01:00:00Z","last_updated_date":"2014-03-20T01:00:00Z","reference_number":"EMA/58743/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0029-2014-european-medicines-agency-decision-13-february-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-clazakizumab-emea-001371-pip0_en.pdf"},
    {"id":"29036","name":"P/68/2010: European Medicines Agency decision on the granting of a product specific waiver for sorafenib (as tosylate) (Nexavar) (EMEA-000781-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/264450/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-68-2010-european-medicines-agency-decision-granting-product-specific-waiver-sorafenib-tosylate-nexavar-emea-000781-pip01-09_en.pdf"},
    {"id":"29037","name":"P/0039/2012: EMA decision of 24 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaflor (EMEA-\n\n000335-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/97657/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2012-ema-decision-24-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivacaflor-emea-000335-pip01-08-m05_en.pdf"},
    {"id":"29049","name":"P/235/2010: EMA decision of 26 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for eptacog alfa pegol (activated) (EMEA-000189-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/720293/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-235-2010-ema-decision-26-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-eptacog-alfa-pegol-activated-emea-000189-pip01-08-m01_en.pdf"},
    {"id":"29051","name":"P/0131/2018: EMA decision of 13 April 2018 on the granting of a product specific waiver for clostridium botulinum neurotoxin type A (150 kD), free from complexing proteins (Xeomin, Bocouture), (EMEA-001039-PIP03-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-26T02:00:00Z","last_updated_date":"2018-07-26T02:00:00Z","reference_number":"EMA/501922/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2018-ema-decision-13-april-2018-granting-product-specific-waiver-clostridium-botulinum-neurotoxin-type-150-kd-free-complexing-proteins-xeomin-bocouture-emea-001039-pip03-17_en.pdf"},
    {"id":"29080","name":"P/0150/2017: EMA decision of 9 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sirukumab (EMEA-001043-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/318383/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0150-2017-ema-decision-9-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-sirukumab-emea-001043-pip01-10-m03_en.pdf"},
    {"id":"29129","name":"P/219/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for 12 grass pollen extract, cultiva...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/627636/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-219-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-12-grass-pollen-extract-cultiva_en.pdf"},
    {"id":"29132","name":"P/0214/2013: EMA decision of 3 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for glycerol phenylbutyrate (GPB) (EMEA-000297-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/519775/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2013-ema-decision-3-september-2013-agreement-paediatric-investigation-plan-granting-deferral-glycerol-phenylbutyrate-gpb-emea-000297-pip02-12_en.pdf"},
    {"id":"29139","name":"P/61/2011: EMA decision of 4 March 2011 on the granting of a product specific waiver for Human Papilloma Virus Type 16 E6 071-095 / Human Papilloma Virus Type 16 E7 064-098 / Human Papilloma Virus Type 16 E6 055 080 / Hu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-04-08T02:00:00Z","last_updated_date":"2011-04-08T02:00:00Z","reference_number":"EMA/78577/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-61-2011-ema-decision-4-march-2011-granting-product-specific-waiver-human-papilloma-virus-type-16-e6-071-095-human-papilloma-virus-type-16-e7-064-098-human-papilloma-virus-type-16-e6-055-080-hu_en.pdf"},
    {"id":"29149","name":"P/0130/2013: EMA decision of 28 May 2013 on the granting of a product-specific waiver for valsartan / hydrochlorothiazide + rosuvastatin (EMEA-001408-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/250243/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2013-ema-decision-28-may-2013-granting-product-specific-waiver-valsartan-hydrochlorothiazide-rosuvastatin-emea-001408-pip01-12_en.pdf"},
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    {"id":"29190","name":"P/0283/2017: EMA decision of 4 October 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for\n\nphenyl- and piperidin-containing derivative of amiloride (BI 443651)\n\n(EMEA-002082-PI...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-03-26T02:00:00Z","reference_number":"EMA/565683/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0283-2017-ema-decision-4-october-2017-agreement-paediatric-investigation-plan-granting-deferral-phenyl-piperidin-containing-derivative-amiloride-bi-443651-emea-002082-pi_en.pdf"},
    {"id":"29214","name":"P/0199/2016: EMA decision of 18 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for andexanet alfa\n\n(EMEA-001902-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/479450/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2016-ema-decision-18-july-2016-agreement-paediatric-investigation-plan-granting-deferral-andexanet-alfa-emea-001902-pip01-15_en.pdf"},
    {"id":"29272","name":"P/0212/2014: EMA decision of 1 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for cobicistat (Tybost), (EMEA-000969-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/464765/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2014-ema-decision-1-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-cobicistat-tybost-emea-000969-pip01-10-m03_en.pdf"},
    {"id":"29297","name":"P/0118/2016: EMA decision of 22 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/249406/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0118-2016-ema-decision-22-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-fycompa-emea-000467-pip01-08-m07_en.pdf"},
    {"id":"29316","name":"P/0178/2014: EMA decision of 7 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir (Sovaldi) (EMEA-001276-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/392133/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2014-ema-decision-7-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-sofosbuvir-sovaldi-emea-001276-pip01-12-m01_en.pdf"},
    {"id":"29319","name":"P/168/2010: European Medicines Agency decision of 3 September 2010 on the granting of a product specific waiver for lixisenatide / insulin glargine,\n\n(EMEA-000915-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/477369/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-168-2010-european-medicines-agency-decision-3-september-2010-granting-product-specific-waiver-lixisenatide-insulin-glargine-emea-000915-pip01-10_en.pdf"},
    {"id":"29353","name":"P/334/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for aqueous allergen extract of grass and rye pollen (EM...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/814935/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-334-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aqueous-allergen-extract-grass-rye-pollen-em_en.pdf"},
    {"id":"29355","name":"P/0076/2014: EMA decision of 2 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for bimatoprost (Lumigan and associated names), (EMEA-000917-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/113584/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2014-ema-decision-2-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-bimatoprost-lumigan-associated-names-emea-000917-pip01-10-m03_en.pdf"},
    {"id":"29371","name":"P/0368/2016: EMA decision of 21 December 2016 on the granting of a product specific waiver for netarsudil (EMEA-002037-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/826798/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0368-2016-ema-decision-21-december-2016-granting-product-specific-waiver-netarsudil-emea-002037-pip01-16_en.pdf"},
    {"id":"29387","name":"P/0045/2016: EMA decision of 26 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/131042/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2016-ema-decision-26-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m02_en.pdf"},
    {"id":"29415","name":"P/0348/2016: EMA decision of 2 December 2016 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for chlorhexidine gluconate / isopropyl alcohol (EMEA-00201...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/742003/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0348-2016-ema-decision-2-december-2016-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-chlorhexidine-gluconate-isopropyl-alcohol-emea-00201_en.pdf"},
    {"id":"29431","name":"P/0156/2014: EMA decision of 18 June 2014 on the granting of a product specific waiver for amoxicillin (in combination with clarithromycin + metronidazole + pantoprazole), (EMEA-001574-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/252172/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2014-ema-decision-18-june-2014-granting-product-specific-waiver-amoxicillin-combination-clarithromycin-metronidazole-pantoprazole-emea-001574-pip01-13_en.pdf"},
    {"id":"29452","name":"P/40/2011: EMA decision of 3 February 2011 on the granting of a product specific waiver for romidepsin (EMEA-001023-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2011-03-08T01:00:00Z","reference_number":"EMA/65907/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-40-2011-ema-decision-3-february-2011-granting-product-specific-waiver-romidepsin-emea-001023-pip01-10_en.pdf"},
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    {"id":"29526","name":"P/155/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for sotrastaurin (acetate)\n\n(EMEA-000093-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/485323/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-155-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-sotrastaurin-acetate-emea-000093-pip01-07-m01_en.pdf"},
    {"id":"29536","name":"P/0302/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate) (Lixiana), (EMEA-000788-PIP02-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/785817/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-edoxaban-tosylate-lixiana-emea-000788-pip02-11-m04_en.pdf"},
    {"id":"29537","name":"P/202/2011: EMA decision of 26 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for Modified Grass Pollen Extract (EMEA-000284-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/648927/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-202-2011-ema-decision-26-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-modified-grass-pollen-extract-emea-000284-pip01-08-m02_en.pdf"},
    {"id":"29598","name":"P/0308/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for fremanezumab\n\n(EMEA-001877-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/666633/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2017-ema-decision-31-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-fremanezumab-emea-001877-pip01-15-m01_en.pdf"},
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    {"id":"29606","name":"Meningococcal group A oligosaccharide Conjugated to Corynebacterium diphteriae CRM197 protein, meningococcal group C oligosaccharide Conjugated to Corynebacterium diphteriae CRM197 protein, meningococcal group W-135 olig...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2011-03-08T01:00:00Z","reference_number":"EMA/84850/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/meningococcal-group-oligosaccharide-conjugated-corynebacterium-diphteriae-crm197-protein-meningococcal-group-c-oligosaccharide-conjugated-corynebacterium-diphteriae-crm197-protein-meningococcal-group_en.pdf"},
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    {"id":"29646","name":"P/0038/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for perindopril / indapamide / amlodipine (EMEA-001355-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/23778/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0038-2013-ema-decision-27-february-2013-granting-product-specific-waiver-perindopril-indapamide-amlodipine-emea-001355-pip01-12_en.pdf"},
    {"id":"29694","name":"P/0205/2016: EMA decision of 4 August 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for risankizumab (EMEA-001776-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/512975/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2016-ema-decision-4-august-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-risankizumab-emea-001776-pip01-15_en.pdf"},
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    {"id":"29730","name":"P/0153/2016: EMA decision of 14 June 2016 on the granting of a product specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/334199/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2016-ema-decision-14-june-2016-granting-product-specific-waiver-ibuprofen-tramadol-emea-001887-pip01-15_en.pdf"},
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    {"id":"29758","name":"P/0231/2014: EMA decision of 5 September 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for trifarotene (EMEA-001492-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/468799/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2014-ema-decision-5-september-2014-agreement-paediatric-investigation-plan-granting-waiver-trifarotene-emea-001492-pip01-13_en.pdf"},
    {"id":"29759","name":"P/114/2012: EMA decision of 29 June 2012 on the granting of a product specific waiver for amlodipine (besilate) / valsartan (EMEA-001247-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-19T17:00:00Z","last_updated_date":"2012-07-19T17:00:00Z","reference_number":"EMA/332315/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-114-2012-ema-decision-29-june-2012-granting-product-specific-waiver-amlodipine-besilate-valsartan-emea-001247-pip01-11_en.pdf"},
    {"id":"29763","name":"P/0032/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta) (EMEA-000498-PIP01-08-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T11:41:00Z","last_updated_date":"2018-04-18T11:41:00Z","reference_number":"EMA/848761/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0032-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-trajenta-emea-000498-pip01-08-m07_en.pdf"},
    {"id":"29781","name":"P/0332/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for amlodipine / irbesartan / hydrochlorothiazide (EMEA-\n\n002167-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/666337/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0332-2017-ema-decision-31-october-2017-granting-product-specific-waiver-amlodipine-irbesartan-hydrochlorothiazide-emea-002167-pip01-17_en.pdf"},
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    {"id":"29817","name":"P/0282/2017: EMA decision of 4 October 2017 on the granting of a product specific waiver for ramucirumab (Cyramza), (EMEA-002074-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/565636/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0282-2017-ema-decision-4-october-2017-granting-product-specific-waiver-ramucirumab-cyramza-emea-002074-pip01-16_en.pdf"},
    {"id":"29818","name":"P/0190/2013: EMA decision of 9 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names) (EMEA-000573-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-10T13:35:00Z","last_updated_date":"2013-09-10T13:35:00Z","reference_number":"EMA/476109/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2013-ema-decision-9-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip02-13-m01_en.pdf"},
    {"id":"29826","name":"P/223/2010: European Medicines Agency decision of 29 October 2010 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for phentermine / topiramate, (EMEA-000...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/654862/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-223-2010-european-medicines-agency-decision-29-october-2010-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-phentermine-topiramate-emea-000_en.pdf"},
    {"id":"29836","name":"P/11/2009: European Medicines Agency decision of 27 January 2009 on refusal of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for Human Papillomavirus type 16 L1 protein,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/30247/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-11-2009-european-medicines-agency-decision-27-january-2009-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-human-papillomavirus-type-16-l1-protein_en.pdf"},
    {"id":"29868","name":"P/0121/2015: EMA decision of 5 June 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for peanut allergen extract (EMEA-001481-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T02:00:00Z","last_updated_date":"2015-07-03T02:00:00Z","reference_number":"EMA/297899/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2015-ema-decision-5-june-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-peanut-allergen-extract-emea-001481-pip01-13_en.pdf"},
    {"id":"29892","name":"P/0314/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for grazoprevir / elbasvir (EMEA-001604-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/761439/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0314-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-grazoprevir-elbasvir-emea-001604-pip01-13-m01_en.pdf"},
    {"id":"29893","name":"P/0240/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human\n\nN-acetylgalactosamine-6-sulfatase (EMEA-000973-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/660447/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0240-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-n-acetylgalactosamine-6-sulfatase-emea-000973-pip01-10-m01_en.pdf"},
    {"id":"29897","name":"P/312/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for aciclovir (Sitavig and associated names) (EMEA-001066-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/717745/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-312-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-aciclovir-sitavig-associated-names-emea-001066-pip02-11-m01_en.pdf"},
    {"id":"29912","name":"P/16/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide, (Imprida HCT), (EMEA-000399-PIP01-08) in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/24175/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-16-2009-european-medicines-agency-decision-27-january-2009-granting-product-specific-waiver-amlodipine-besylate-valsartan-hydrochlorothiazide-imprida-hct-emea-000399-pip01-08-accordance-w_en.pdf"},
    {"id":"29923","name":"P/0014/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for budesonide (EMEA-\n\n001087-PIP02-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/38337/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-budesonide-emea-001087-pip02-12-m03_en.pdf"},
    {"id":"29950","name":"P/0276/2014: EMA decision of 28 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for belimumab (Benlysta), (EMEA-000520-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-04T01:00:00Z","last_updated_date":"2014-12-04T01:00:00Z","reference_number":"EMA/587684/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0276-2014-ema-decision-28-october-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-belimumab-benlysta-emea-000520-pip02-13_en.pdf"},
    {"id":"29958","name":"P/227/2009: European Medicines Agency Decision of 4 November 2009 on the granting of a product specific waiver for olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide (EMEA-000667-PIP01-09) in accordance wit...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:09:21Z","last_updated_date":"2009-12-23T00:09:21Z","reference_number":"EMEA/693325/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-227-2009-european-medicines-agency-decision-4-november-2009-granting-product-specific-waiver-olmesartan-medoxomil-amlodipine-besilate-hydrochlorothiazide-emea-000667-pip01-09-accordance-wit_en.pdf"},
    {"id":"29971","name":"P/0031/2012: EMA decision of 2 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine\n\n(hydrochloride) (Corlentor), (EMEA-000627-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-15T14:30:00Z","last_updated_date":"2012-03-15T14:30:00Z","reference_number":"EMA/62804/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0031-2012-ema-decision-2-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-corlentor-emea-000627-pip01-09-m02_en.pdf"},
    {"id":"29993","name":"P/0093/2018: EMA decision of 16 March 2018 on the granting of a product specific waiver for candesartan (cilexetil) / amlodipine (besylate) (EMEA-002248-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/100992/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2018-ema-decision-16-march-2018-granting-product-specific-waiver-candesartan-cilexetil-amlodipine-besylate-emea-002248-pip01-17_en.pdf"},
    {"id":"30006","name":"P/226/2011: EMA decision of 27 September 2011 on the refusal of a product specific waiver for antithrombin alfa (ATryn) (EMEA-001154-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-18T02:00:00Z","last_updated_date":"2011-10-18T02:00:00Z","reference_number":"EMA/710340/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-226-2011-ema-decision-27-september-2011-refusal-product-specific-waiver-antithrombin-alfa-atryn-emea-001154-pip01-11_en.pdf"},
    {"id":"30024","name":"P/0286/2012: EMA decision of 23 November 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ponesimod (EMEA-000798-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-07T01:00:00Z","last_updated_date":"2013-01-07T01:00:00Z","reference_number":"EMA/734844/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0286-2012-ema-decision-23-november-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ponesimod-emea-000798-pip01-09_en.pdf"},
    {"id":"30035","name":"P/0273/2012: EMA decision of of 21 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi, Ipreziv), (EMEA-000237-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/680042/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0273-2012-ema-decision-21-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-azilsartan-medoxomil-edarbi-ipreziv-emea-000237-pip01-08-m04_en.pdf"},
    {"id":"30042","name":"P/0295/2017: EMA decision of 29 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for entolimod (EMEA-\n\n002020-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/630131/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2017-ema-decision-29-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-entolimod-emea-002020-pip01-16-m01_en.pdf"},
    {"id":"30059","name":"P/0207/2012: EMA decision of 21 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (EMEA-000694-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/598488/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2012-ema-decision-21-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-emea-000694-pip01-09-m01_en.pdf"},
    {"id":"30066","name":"P/0055/2012: EMA decision of 26 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for rabeprazole (sodium) (Pariet and associated names), (EMEA-000055-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T17:42:00Z","last_updated_date":"2012-04-20T17:42:00Z","reference_number":"EMA/124630/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2012-ema-decision-26-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-rabeprazole-sodium-pariet-associated-names-emea-000055-pip01-07-m05_en.pdf"},
    {"id":"30067","name":"P/105/2010: European Medicines Agency decision of 25 June 2010\n\non the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Afinitor) (EMEA-000019-PIP02-07-M01) in accordance with Regul...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/415023/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-105-2010-european-medicines-agency-decision-25-june-2010-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-afinitor-emea-000019-pip02-07-m01-accordance-regul_en.pdf"},
    {"id":"30070","name":"P/0035/2017: European Medicines Agency decision of 31 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vadadustat (EMEA-001944-PIP01-1...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/38355/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0035-2017-european-medicines-agency-decision-31-january-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vadadustat-emea-001944-pip01-1_en.pdf"},
    {"id":"30078","name":"P/0184/2015: EMA decision of 21 August 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for glucagon (EMEA-001657-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-24T02:00:00Z","last_updated_date":"2015-09-24T02:00:00Z","reference_number":"EMA/473658/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2015-ema-decision-21-august-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-glucagon-emea-001657-pip01-14_en.pdf"},
    {"id":"30091","name":"P/136/2009: European Medicines Agency decision of 15 July 2009\n\non the agreement of a Paediatric Investigation Plan and on the granting of a waiver for insulin glargine (Optisulin) (EMEA-000396-PIP01-08) in accordance wi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/387961/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-136-2009-european-medicines-agency-decision-15-july-2009-agreement-paediatric-investigation-plan-granting-waiver-insulin-glargine-optisulin-emea-000396-pip01-08-accordance-wi_en.pdf"},
    {"id":"30096","name":"P/0262/2016: EMA decision of 5 October 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for copanlisib (EMEA-001757-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/592849/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0262-2016-ema-decision-5-october-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-copanlisib-emea-001757-pip02-15_en.pdf"},
    {"id":"30104","name":"P/0097/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/186586/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2014-ema-decision-7-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"30110","name":"P/0040/2013: EMA decision of 27 February 2013 on the granting of a product-specific waiver for amlodipine / losartan (EMEA-001380-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/24016/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2013-ema-decision-27-february-2013-granting-product-specific-waiver-amlodipine-losartan-emea-001380-pip01-12_en.pdf"},
    {"id":"30119","name":"P/0164/2016: EMA decision of 15 June 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for bexagliflozin (EMEA-001841-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/336929/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2016-ema-decision-15-june-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bexagliflozin-emea-001841-pip01-15_en.pdf"},
    {"id":"30130","name":"P/164/2011: EMA decision of 4 July 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for canagliflozin (EMEA-001030-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/487800/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-164-2011-ema-decision-4-july-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-canagliflozin-emea-001030-pip01-10_en.pdf"},
    {"id":"30143","name":"P/0290/2015: EMA decision of 27 November 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for olaratumab (EMEA-001760-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/688273/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0290-2015-ema-decision-27-november-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-olaratumab-emea-001760-pip01-15_en.pdf"},
    {"id":"30156","name":"P/100/2010: European Medicines Agency decision of 11 June 2010\n\non the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dapagliflozin (EMEA-000694-PIP01-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/352334/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-100-2010-european-medicines-agency-decision-11-june-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dapagliflozin-emea-000694-pip01-0_en.pdf"},
    {"id":"30180","name":"P/0012/2013: EMA decision of 23 January 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for everolimus (Votubia) (EMEA-000019-PIP08-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T14:30:00Z","last_updated_date":"2013-04-03T14:30:00Z","reference_number":"EMA/27942/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2013-ema-decision-23-january-2013-agreement-paediatric-investigation-plan-granting-deferral-everolimus-votubia-emea-000019-pip08-12_en.pdf"},
    {"id":"30183","name":"P/0161/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca\n\nand associated names), (EMEA-001231-PIP02-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/314188/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m03_en.pdf"},
    {"id":"30189","name":"P/0169/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/473608/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-neisseria-meningitidis-serogroup-b-recombinant-lipoprotein-rlp2086-subfamily-escherichia_en.pdf"},
    {"id":"30224","name":"P/0316/2015: EMA decision of 21 December 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emtricitabine / tenofovir alafenamide / Sodium (2R,5...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/791470/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0316-2015-ema-decision-21-december-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-emtricitabine-tenofovir-alafenamide-sodium-2r5_en.pdf"},
    {"id":"30226","name":"P/129/2010:  European Medicines Agency decision of 28 July 2010 on the refusal of a paediatric investigation plan and on the granting of a waiver for 4-0-(àŸ-D-galactopiranosyl)-D-xylopyranose (EMEA-000641-PIP01-09) in a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/464155/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-129-2010-european-medicines-agency-decision-28-july-2010-refusal-paediatric-investigation-plan-granting-waiver-4-0-ay-d-galactopiranosyl-d-xylopyranose-emea-000641-pip01-09_en.pdf"},
    {"id":"30236","name":"P/0235/2015: EMA decision of 27 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for patiromer calcium (EMEA-001720-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T01:00:00Z","last_updated_date":"2015-12-21T01:00:00Z","reference_number":"EMA/645778/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2015-ema-decision-27-october-2015-agreement-paediatric-investigation-plan-granting-deferral-patiromer-calcium-emea-001720-pip01-14_en.pdf"},
    {"id":"30246","name":"P/132/2010: European Medicines Agency decision of 28 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated, containing antigen: A/California/7/200...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-27T01:09:21Z","last_updated_date":"2010-08-27T01:09:21Z","reference_number":"EMA/425577/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-132-2010-european-medicines-agency-decision-28-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigen-california-7-200_en.pdf"},
    {"id":"30262","name":"P/0256/2014: EMA decision of 1 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for migalastat (hydrochloride) (EMEA-001194-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/514341/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2014-ema-decision-1-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-migalastat-hydrochloride-emea-001194-pip01-11-m01_en.pdf"},
    {"id":"30280","name":"P/0378/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lanadelumab (DX-\n\n2930) (EMEA-001864-PIP01-15-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T16:03:00Z","last_updated_date":"2018-03-02T16:03:00Z","reference_number":"EMA/774069/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0378-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-lanadelumab-dx-2930-emea-001864-pip01-15-m01_en.pdf"},
    {"id":"30284","name":"P/91/2008: European medicines agency decision of 14 October 2008 on the application for product specific waiver for chimeric murine-human anti Interleukin 6 monoclonal antibody EMEA-000323-PIP01-08 in accordance with Reg...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/522198/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-91-2008-european-medicines-agency-decision-14-october-2008-application-product-specific-waiver-chimeric-murine-human-anti-interleukin-6-monoclonal-antibody-emea-000323-pip01-08-accordance-reg_en.pdf"},
    {"id":"30288","name":"P/87/2011: EMA decision of 8 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for Japanese encephalitis\n\nvirus, inactivated (attenuated strain SA14-14-2 grown in vero cells) (Ixia...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/278824/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-87-2011-ema-decision-8-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-japanese-encephalitis-virus-inactivated-attenuated-strain-sa14-14-2-grown-vero-cells-ixia_en.pdf"},
    {"id":"30291","name":"P/0280/2013: EMA decision of 8 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names, Tapen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-12-06T01:00:00Z","last_updated_date":"2013-12-06T01:00:00Z","reference_number":"EMA/670446/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0280-2013-ema-decision-8-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapen_en.pdf"},
    {"id":"30297","name":"P/0022/2014: EMA decision of 22 January 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for etrolizumab (EMEA-001434-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/12887/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0022-2014-ema-decision-22-january-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-etrolizumab-emea-001434-pip01-13_en.pdf"},
    {"id":"30310","name":"P/41/2008: European medicines agency decision of 24 June 2008\n\non the application for product specific waiver for elocalcitol (EMEA-000182-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliam...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/313552/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-41-2008-european-medicines-agency-decision-24-june-2008-application-product-specific-waiver-elocalcitol-emea-000182-pip01-08-accordance-regulation-ec-no-1901-2006-european-parliam_en.pdf"},
    {"id":"30311","name":"P/0244/2012: EMA decision of 22 October 2012 on the granting of a product specific waiver for dexketoprofen (trometamol) / tramadol (hydrochloride)\n\n(EMEA-001302-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/660593/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0244-2012-ema-decision-22-october-2012-granting-product-specific-waiver-dexketoprofen-trometamol-tramadol-hydrochloride-emea-001302-pip01-12_en.pdf"},
    {"id":"30317","name":"P/08/2009: European Medicines Agency decision of 27 January 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for apixaban (EMEA-000183-PIP01-08) i...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/32088/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-08-2009-european-medicines-agency-decision-27-january-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-apixaban-emea-000183-pip01-08-i_en.pdf"},
    {"id":"30326","name":"P/0034/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for telaprevir (Incivo), (EMEA-000196-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/54901/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-telaprevir-incivo-emea-000196-pip01-08-m02_en.pdf"},
    {"id":"30367","name":"P/182/2011: EMA decision of 3 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for corifollitropin alfa (Elonva) (EMEA-000306-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/544597/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-182-2011-ema-decision-3-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-corifollitropin-alfa-elonva-emea-000306-pip01-08-m01_en.pdf"},
    {"id":"30384","name":"P/284/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for lanthanum carbonate hydrate (Fosrenol and associated ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-11T01:00:00Z","last_updated_date":"2011-01-11T01:00:00Z","reference_number":"EMA/683431/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-284-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lanthanum-carbonate-hydrate-fosrenol-associated_en.pdf"},
    {"id":"30425","name":"P/0294/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for autologous cartilage\n\nderived cultured chondrocytes (EMEA-000979-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/693018/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cartilage-derived-cultured-chondrocytes-emea-000979-pip01-10-m01_en.pdf"},
    {"id":"30431","name":"P/0091/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for turoctocog alfa (EMEA-000428-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/180067/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-turoctocog-alfa-emea-000428-pip01-08-m02_en.pdf"},
    {"id":"30476","name":"P/0278/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pollen from Betula pendula (EMEA-000853-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/732744/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0278-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-pollen-betula-pendula-emea-000853-pip01-10-m01_en.pdf"},
    {"id":"30495","name":"P/0071/2014: EMA decision of 21 March 2014 on the agreement of a paediatric investigation plan and on the refusal of a waiver for cyclic pyranopterin monophosphate (monohydrobromide dihydrate) (EMEA-001491-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2014-05-13T02:00:00Z","reference_number":"EMA/113591/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2014-ema-decision-21-march-2014-agreement-paediatric-investigation-plan-refusal-waiver-cyclic-pyranopterin-monophosphate-monohydrobromide-dihydrate-emea-001491-pip01-13_en.pdf"},
    {"id":"30540","name":"P/0024/2013: EMA decision of 26 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa (Ruconest) (EMEA-000367-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/89683/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0024-2013-ema-decision-26-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-conestat-alfa-ruconest-emea-000367-pip01-08-m02_en.pdf"},
    {"id":"30542","name":"P/0019/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/864480/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-invokana-emea-001030-pip01-10-m05_en.pdf"},
    {"id":"30580","name":"P/22/2009: European Medicines Agency decision of 23 February 2009 on the refusal of a Paediatric Investigation Plan and on the refusal of a waiver for candesartan cilexetil (Blopress and associated names), (EMEA-000023-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/96351/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-22-2009-european-medicines-agency-decision-23-february-2009-refusal-paediatric-investigation-plan-refusal-waiver-candesartan-cilexetil-blopress-associated-names-emea-000023-p_en.pdf"},
    {"id":"30583","name":"P/0121/2016: EMA decision of 29 April 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sofosbuvir / velpatasvir / a derivative of (2S,3S,4R)-3...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/265338/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2016-ema-decision-29-april-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sofosbuvir-velpatasvir-derivative-2s3s4r-3_en.pdf"},
    {"id":"30599","name":"P/0356/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for eculizumab (Soliris), (EMEA-000876-PIP03-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/827230/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0356-2016-ema-decision-21-december-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eculizumab-soliris-emea-000876-pip03-14_en.pdf"},
    {"id":"30605","name":"P/117/2010: European Medicines Agency decision of 7 July 2010 on the granting of a product specific waiver for diclofenac sodium / omeprazole\n\n(EMEA-000820-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/343648/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-117-2010-european-medicines-agency-decision-7-july-2010-granting-product-specific-waiver-diclofenac-sodium-omeprazole-emea-000820-pip01-09-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"30606","name":"P/0095/2015: EMA decision of 8 May 2015 on the refusal of a paediatric investigation plan and on the granting of a waiver for masitinib (mesylate) (EMEA-001266-PIP02-14)on the agreement of a paediatric investigation plan...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/205920/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0095-2015-ema-decision-8-may-2015-refusal-paediatric-investigation-plan-granting-waiver-masitinib-mesylate-emea-001266-pip02-14on-agreement-paediatric-investigation-plan_en.pdf"},
    {"id":"30646","name":"P/0030/2013: EMA decision of 26 February 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for proteinase, metallo- (synthetic nociceptin receptor-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/24831/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2013-ema-decision-26-february-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-proteinase-metallo-synthetic-nociceptin-receptor_en.pdf"},
    {"id":"30664","name":"P/229/2011: EMA decision of 28 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ozenoxacin (EMEA-\n\n000981-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/693053/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-229-2011-ema-decision-28-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-ozenoxacin-emea-000981-pip01-10-m01_en.pdf"},
    {"id":"30674","name":"P/50/2009: European Medicines Agency decision of 24 March 2009 on the granting of a product specific waiver for bisoprolol fumarate / acetylsalicylic acid (EMEA-000445-PIP01-08) in accordance with Regulation (EC) No 1901...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/157735/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-50-2009-european-medicines-agency-decision-24-march-2009-granting-product-specific-waiver-bisoprolol-fumarate-acetylsalicylic-acid-emea-000445-pip01-08-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"30698","name":"P/0292/2014: EMA decision of 24 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tigecycline (Tygacil), (EMEA-000120-PIP01-07-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2014-12-05T01:00:00Z","last_updated_date":"2014-12-05T01:00:00Z","reference_number":"EMA/640003/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0292-2014-ema-decision-24-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-tigecycline-tygacil-emea-000120-pip01-07-m05_en.pdf"},
    {"id":"30706","name":"P/0308/2012: EMA decision of 21 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for linagliptin (Trajenta), (EMEA-000498-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-07T13:30:00Z","last_updated_date":"2013-02-07T13:30:00Z","reference_number":"EMA/809648/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0308-2012-ema-decision-21-december-2012-acceptance-modification-agreed-paediatric-investigation-plan-linagliptin-trajenta-emea-000498-pip01-08-m01_en.pdf"},
    {"id":"30717","name":"P/97/2008: European medicines agency decision of 3 November 2008\n\non the application for agreement of a Paediatric Investigation Plan for aprepitant (EMEND), EMEA-000144-PIP01-07 in accordance with Regulation (EC) No 190...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-07T00:00:00Z","last_updated_date":"2009-01-07T00:00:00Z","reference_number":"EMEA/562760/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-97-2008-european-medicines-agency-decision-3-november-2008-application-agreement-paediatric-investigation-plan-aprepitant-emend-emea-000144-pip01-07-accordance-regulation-ec-no-190_en.pdf"},
    {"id":"30719","name":"P/0091/2012: EMA decision of 29 May 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for vonicog alfa (EMEA-001164-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/330397/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2012-ema-decision-29-may-2012-agreement-paediatric-investigation-plan-granting-deferral-vonicog-alfa-emea-001164-pip01-11_en.pdf"},
    {"id":"30724","name":"P/200/2011: EMA decision of 5 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel)\n\n(EMEA-000567-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/635452/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-200-2011-ema-decision-5-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-dasatinib-sprycel-emea-000567-pip01-09-m02_en.pdf"},
    {"id":"30734","name":"P/37/2009: European Medicines Agency decision of 23 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for clevidipine butyrate (EMEA-000282-PIP01-08) in accordance with R...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/96585/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-37-2009-european-medicines-agency-decision-23-february-2009-agreement-paediatric-investigation-plan-granting-deferral-clevidipine-butyrate-emea-000282-pip01-08-accordance-r_en.pdf"},
    {"id":"30783","name":"P/0227/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sotagliflozin (EMEA-\n\n001517-PIP02-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/430901/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-sotagliflozin-emea-001517-pip02-14-m01_en.pdf"},
    {"id":"30857","name":"P/0337/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (EMEA-001582-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T01:00:00Z","last_updated_date":"2015-02-23T01:00:00Z","reference_number":"EMA/719228/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0337-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-lumacaftor-ivacaftor-emea-001582-pip01-13-m02_en.pdf"},
    {"id":"30867","name":"P/0394/2017: EMA decision of 19 December 2017 on the granting of a product specific waiver for synthetic double-stranded small interfering RNA (siRNA)\n\noligonucleotide specific to the mRNA of the caspase 2 gene (QPI-1007...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T14:03:00Z","last_updated_date":"2018-03-07T14:03:00Z","reference_number":"EMA/797358/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0394-2017-ema-decision-19-december-2017-granting-product-specific-waiver-synthetic-double-stranded-small-interfering-rna-sirna-oligonucleotide-specific-mrna-caspase-2-gene-qpi-1007_en.pdf"},
    {"id":"30875","name":"P/174/2011: EMA decision of 8 July 2011 on the granting of a product specific waiver for pravastatin (sodium) / acetylsalicylic acid (EMEA-\n\n001118-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/522147/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-174-2011-ema-decision-8-july-2011-granting-product-specific-waiver-pravastatin-sodium-acetylsalicylic-acid-emea-001118-pip01-10_en.pdf"},
    {"id":"30881","name":"P/0160/2015: EMA decision of 13 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (EMEA-001501-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/382954/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2015-ema-decision-13-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-emea-001501-pip02-13-m01_en.pdf"},
    {"id":"30882","name":"P/0253/2012: EMA decision of 30 November 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for spheroids of human autologous matrix-associated chon...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"EMA/751595/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0253-2012-ema-decision-30-november-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-spheroids-human-autologous-matrix-associated-chon_en.pdf"},
    {"id":"30887","name":"P/0209/2012: EMA decision of 27 September 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for ceftobiprole medocaril (sodium) (EMEA-000205-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T18:45:00Z","last_updated_date":"2012-10-17T18:45:00Z","reference_number":"EMA/605416/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2012-ema-decision-27-september-2012-agreement-paediatric-investigation-plan-granting-deferral-ceftobiprole-medocaril-sodium-emea-000205-pip02-11_en.pdf"},
    {"id":"30900","name":"P/0005/2013: EMA decision of 21 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for valganciclovir (Valcyte and associated names), (EMEA-000726-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/19909/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2013-ema-decision-21-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-valganciclovir-valcyte-associated-names-emea-000726-pip01-09-m01_en.pdf"},
    {"id":"30909","name":"P/0037/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for lanthanum carbonate hydrate (Fosrenol and associated names) (EMEA-000637-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/54828/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-lanthanum-carbonate-hydrate-fosrenol-associated-names-emea-000637-pip02-10-m03_en.pdf"},
    {"id":"30944","name":"P/0042/2015: EMA decision of 6 March 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for coagulation factor VIIa (recombinant) (EMEA-001203-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-23T01:00:00Z","last_updated_date":"2015-03-23T01:00:00Z","reference_number":"EMA/49380/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2015-ema-decision-6-march-2015-agreement-paediatric-investigation-plan-granting-waiver-coagulation-factor-viia-recombinant-emea-001203-pip02-14_en.pdf"},
    {"id":"30958","name":"P/116/2009: European Medicines Agency decision of 16 June 2009\n\non the granting of a product specific waiver for human plasma proteins\n\n(EMEA-000507-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Europe...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351605/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-116-2009-european-medicines-agency-decision-16-june-2009-granting-product-specific-waiver-human-plasma-proteins-emea-000507-pip01-08-accordance-regulation-ec-no-1901-2006-europe_en.pdf"},
    {"id":"30960","name":"P/122/2011: EMA decision of 7 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for treosulfan (EMEA-000883-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/359711/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-122-2011-ema-decision-7-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-treosulfan-emea-000883-pip01-10_en.pdf"},
    {"id":"30977","name":"P/120/2011: EMA decision of 7 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for ombrabulin\n\n(EMEA-000800-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/426561/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-120-2011-ema-decision-7-june-2011-agreement-paediatric-investigation-plan-granting-deferral-ombrabulin-emea-000800-pip01-09_en.pdf"},
    {"id":"30978","name":"P/0156/2017: EMA decision of 8 June 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for fluocinolone acetonide (EMEA-000801-PIP03-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/343374/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2017-ema-decision-8-june-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fluocinolone-acetonide-emea-000801-pip03-16_en.pdf"},
    {"id":"30983","name":"P/0023/2012: EMA decision of 27 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for (S)-3'-(OH)-\n\ndesazadesferrithiocin-polyether, magnesium salt (FBS0701), (EMEA-001057-PIP01-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/985539/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0023-2012-ema-decision-27-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-s-3-oh-desazadesferrithiocin-polyether-magnesium-salt-fbs0701-emea-001057-pip01_en.pdf"},
    {"id":"30994","name":"P/247/2011: EMA decision of 21 October 2011 on the granting of a product specific waiver for (2S,3R,4R,5S,6R)-2-(4-Chloro-3-{3-[(S)-(tetrahydrofuran-3-yl)oxy]-benzyl}-phenyl)-6-hydroxymethyltetrahydro-pyran-3,4,5-triol /...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-28T17:00:00Z","last_updated_date":"2011-11-28T17:00:00Z","reference_number":"EMA/826136/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-247-2011-ema-decision-21-october-2011-granting-product-specific-waiver-2s3r4r5s6r-2-4-chloro-3-3-s-tetrahydrofuran-3-yloxy-benzyl-phenyl-6-hydroxymethyltetrahydro-pyran-345-triol_en.pdf"},
    {"id":"30996","name":"P/0263/2014: EMA decision of 3 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for brentuximab vedotin (Adcetris), (EMEA-000980-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/508722/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0263-2014-ema-decision-3-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-brentuximab-vedotin-adcetris-emea-000980-pip01-10-m02_en.pdf"},
    {"id":"31017","name":"P/244/2011: EMA decision of 7 October 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for L-Cysteinyl-L-prolyl-L-alanyl-L-valyl-L-lysyl-L-arginyl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-28T17:00:00Z","last_updated_date":"2011-11-28T17:00:00Z","reference_number":"EMA/778474/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-244-2011-ema-decision-7-october-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-l-cysteinyl-l-prolyl-l-alanyl-l-valyl-l-lysyl-l-arginyl_en.pdf"},
    {"id":"31029","name":"P/0053/2013: European medicines agency decision of 20 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (EMEA-000645-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/112003/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2013-european-medicines-agency-decision-20-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-vedolizumab-emea-000645-pip01-09-m01_en.pdf"},
    {"id":"31031","name":"P/0183/2016: EMA decision of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for belimumab (Benlysta) (EMEA-000520-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/410886/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0183-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-belimumab-benlysta-emea-000520-pip01-08-m05_en.pdf"},
    {"id":"31033","name":"P/0105/2015: EMA decision of 29 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity) (EMEA-000783-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/282053/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2015-ema-decision-29-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m02_en.pdf"},
    {"id":"31037","name":"P/0060/2014: EMA decision of 7 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/113589/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0060-2014-ema-decision-7-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m09_en.pdf"},
    {"id":"31043","name":"P/0143/2013: EMA decision of 3 July 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Clostridium botulinum neurotoxin type A (150 kD), free of...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-09T16:30:00Z","last_updated_date":"2013-08-09T16:30:00Z","reference_number":"EMA/312139/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2013-ema-decision-3-july-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-clostridium-botulinum-neurotoxin-type-150-kd-free_en.pdf"},
    {"id":"31068","name":"P/323/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass and cereal pollen ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769510/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-323-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-cereal-pollen_en.pdf"},
    {"id":"31081","name":"P/98/2008: European Medicines Agency decision of 3 November 2008 on the application for agreement of a Paediatric Investigation Plan for dienogest (EMEA-000147-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-07T01:00:00Z","last_updated_date":"2009-01-07T01:00:00Z","reference_number":"EMEA/572815/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-98-2008-european-medicines-agency-decision-3-november-2008-application-agreement-paediatric-investigation-plan-dienogest-emea-000147-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"31083","name":"P/0064/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for guanfacine (hydrochloride) (EMEA-000745-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/95728/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-guanfacine-hydrochloride-emea-000745-pip01-09-m02_en.pdf"},
    {"id":"31088","name":"P/0042/2016: EMA decision of 26 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and T...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/133069/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2016-ema-decision-26-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-t_en.pdf"},
    {"id":"31117","name":"P/0206/2013: EMA decision of 3 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for fibrinogen concentrate / thrombin preparation / aprotinin / calcium chloride (EMEA-001079-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/456020/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2013-ema-decision-3-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-fibrinogen-concentrate-thrombin-preparation-aprotinin-calcium-chloride-emea-001079-p_en.pdf"},
    {"id":"31141","name":"P/0057/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dabigatran etexilate (Pradaxa) (EMEA-000081-PIP01-07-M08)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/138298/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-dabigatran-etexilate-pradaxa-emea-000081-pip01-07-m08_en.pdf"},
    {"id":"31161","name":"P/15/2009: European Medicines Agency decision of 27 January 2009 on the granting of a product specific waiver for amlodipine besylate, valsartan, hydrochlorothiazide, (Dafiro HCT), (EMEA-000398-PIP01-08) in accordance wi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/24169/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-15-2009-european-medicines-agency-decision-27-january-2009-granting-product-specific-waiver-amlodipine-besylate-valsartan-hydrochlorothiazide-dafiro-hct-emea-000398-pip01-08-accordance-wi_en.pdf"},
    {"id":"31187","name":"P/0246/2017: EMA decision of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for human normal immunoglobulin (EMEA-002163-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/493695/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2017-ema-decision-4-september-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-human-normal-immunoglobulin-emea-002163-pip01-17_en.pdf"},
    {"id":"31209","name":"P/0341/2017: EMA decision of 16 November 2017 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus\n\nsurface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)/inf...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/731087/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0341-2017-ema-decision-16-november-2017-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-h1n1-inf_en.pdf"},
    {"id":"31210","name":"P/251/2010:  EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aluminium hydroxide adsorbed, depigmented glutaralde...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/670700/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-251-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaralde_en.pdf"},
    {"id":"31263","name":"P/0050/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for loxapine (EMEA-001115-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/108652/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-loxapine-emea-001115-pip01-10-m04_en.pdf"},
    {"id":"31265","name":"P/212/2009: European Medicines Agency decision of 30 October 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for sitagliptin (phosphate monohydrate) (Xelevia) (EMEA-000471-PIP01-08-M01...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/691445/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-212-2009-european-medicines-agency-decision-30-october-2009-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-xelevia-emea-000471-pip01-08-m01_en.pdf"},
    {"id":"31274","name":"P/0252/2017: EMA decision of 4 September 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for selonsertib (EMEA-001868-PIP03-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/498686/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2017-ema-decision-4-september-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-selonsertib-emea-001868-pip03-16_en.pdf"},
    {"id":"31290","name":"P/0336/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca) (EMEA-001231-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/711194/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0336-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-emea-001231-pip02-13-m01_en.pdf"},
    {"id":"31294","name":"P/27/2011: EMA decision of the 28 January 2011on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rizatriptan benzoate (Maxalt and associated names), ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"EMA/37992/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-27-2011-ema-decision-28-january-2011on-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rizatriptan-benzoate-maxalt-associated-names_en.pdf"},
    {"id":"31297","name":"P/0138/2017: EMA decision of 7 June 2017 on the agreement of a paediatric investigation plan for expanded donor-derived allogenic T cells transduced with the retroviral vector expressing the transgenes for inducible casp...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/293456/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2017-ema-decision-7-june-2017-agreement-paediatric-investigation-plan-expanded-donor-derived-allogenic-t-cells-transduced-retroviral-vector-expressing-transgenes-inducible-casp_en.pdf"},
    {"id":"31315","name":"P/288/2010: EMA decision of 22 December 2010 on on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza) (EMEA-000128-PIP01-07-M02","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/756626/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-288-2010-ema-decision-22-december-2010-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m02_en.pdf"},
    {"id":"31332","name":"P/0193/2014: EMA decision of 6 August 2014 on the granting of a product specific waiver for pacritinib (EMEA-001621-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/447502/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2014-ema-decision-6-august-2014-granting-product-specific-waiver-pacritinib-emea-001621-pip01-14_en.pdf"},
    {"id":"31344","name":"P/162/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for (3R,4R)-4- methyl-3-(methyl-7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)-β-oxo-1-piperidinepropanenitri...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/398978/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-162-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-3r4r-4-methyl-3-methyl-7h-pyrrolo23-dpyrimidin-4-ylamino-i2-oxo-1-piperidinepropanenitri_en.pdf"},
    {"id":"31377","name":"P/0185/2014: EMA decision of 6 August 2014 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP03-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/416185/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2014-ema-decision-6-august-2014-granting-product-specific-waiver-ranibizumab-lucentis-emea-000527-pip03-13_en.pdf"},
    {"id":"31379","name":"P/0151/2016: EMA decision of 14 June 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for peanut flour (EMEA-001753-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/334522/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2016-ema-decision-14-june-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-peanut-flour-emea-001753-pip02-15_en.pdf"},
    {"id":"31391","name":"P/257/2011: EMA decision of 26 October 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lixivaptan (EMEA-001078-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/778788/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-257-2011-ema-decision-26-october-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lixivaptan-emea-001078-pip01-10_en.pdf"},
    {"id":"31412","name":"P/0209/2013: EMA decision of 3 September 2013 on the agreement of a paediatric investigation plan for glibenclamide (EMEA-001324-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-07T02:00:00Z","last_updated_date":"2013-10-07T02:00:00Z","reference_number":"EMA/482989/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2013-ema-decision-3-september-2013-agreement-paediatric-investigation-plan-glibenclamide-emea-001324-pip01-12_en.pdf"},
    {"id":"31413","name":"P/0367/2016: EMA decision of 21 December 2016 on the granting of a product specific waiver for DNA plasmid encoding HPV type 16 consensus E6 and\n\nE7 proteins (pGX3001) / DNA plasmid encoding HPV type 18 consensus E6 and ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/791397/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0367-2016-ema-decision-21-december-2016-granting-product-specific-waiver-dna-plasmid-encoding-hpv-type-16-consensus-e6-e7-proteins-pgx3001-dna-plasmid-encoding-hpv-type-18-consensus-e6_en.pdf"},
    {"id":"31420","name":"P/0033/2013: EMA decision of 26 February 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/65700/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2013-ema-decision-26-february-2013-agreement-paediatric-investigation-plan-granting-waiver-26-bis-1-napthalenyl-36-disulfonic-acid-oxyacetamido-26-bis-26-bis-26-bis-2_en.pdf"},
    {"id":"31421","name":"P/0266/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab (RoActemra) (EMEA-000309-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/766676/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-tocilizumab-roactemra-emea-000309-pip01-08-m07_en.pdf"},
    {"id":"31440","name":"P/0130/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for angiotensin II (LJPC-501) (EMEA-001912-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T02:00:00Z","last_updated_date":"2018-07-25T02:00:00Z","reference_number":"EMA/206467/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-angiotensin-ii-ljpc-501-emea-001912-pip02-16-m01_en.pdf"},
    {"id":"31454","name":"Pneumococcal polysaccharide serotypes 1, 4, 5, 6B, 7F, 9V, 14, 23 F conjugated to protein D (derived from non-typeable haemophilus influenzae) carrier protein;\n\nPneumococcal polysaccharide serotype 18C conjugated to teta...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/553987/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/pneumococcal-polysaccharide-serotypes-1-4-5-6b-7f-9v-14-23-f-conjugated-protein-d-derived-non-typeable-haemophilus-influenzae-carrier-protein-pneumococcal-polysaccharide-serotype-18c-conjugated-teta_en.pdf"},
    {"id":"31486","name":"P/0140/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (Cosentyx), (EMEA-000380-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/404947/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-secukinumab-cosentyx-emea-000380-pip01-08-m03_en.pdf"},
    {"id":"31490","name":"P/28/2011: EMA decision of 8 January 2011 on the on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for pegloticase (EMEA-000293-PIP02-10) in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"EMA/13274/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-28-2011-ema-decision-8-january-2011-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-pegloticase-emea-000293-pip02-10-accordance-w_en.pdf"},
    {"id":"31494","name":"P/164/2010: EMA decision of 31 August 2010 on the modification of an agreed paediatric investigation plan for mepolizumab (EMEA-000069-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-07T02:00:00Z","last_updated_date":"2010-10-07T02:00:00Z","reference_number":"EMA/535848/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-164-2010-ema-decision-31-august-2010-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip01-07-m02_en.pdf"},
    {"id":"31499","name":"P/0107/2015: EMA decision of 13 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for emtricitabine / rilpivirine / tenofovir alafenamide (EMEA...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/284193/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0107-2015-ema-decision-13-may-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-emtricitabine-rilpivirine-tenofovir-alafenamide-emea_en.pdf"},
    {"id":"31527","name":"P/0271/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for vigabatrin (EMEA-000717-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/764505/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0271-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-vigabatrin-emea-000717-pip02-13-m01_en.pdf"},
    {"id":"31544","name":"P/141/2010:  European Medicines Agency decision of 30 July 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human monoclonal antib...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/469942/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-141-2010-european-medicines-agency-decision-30-july-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-monoclonal-antib_en.pdf"},
    {"id":"31548","name":"P/0128/2012: EMA decision of 4 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for cabozantinib (EMEA-001143-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/428959/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0128-2012-ema-decision-4-july-2012-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-cabozantinib-emea-001143-pip01-11_en.pdf"},
    {"id":"31563","name":"P/0256/2015: EMA decision of 30 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for fluciclovine (18F) (EMEA-001644-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-21T01:00:00Z","last_updated_date":"2015-12-21T01:00:00Z","reference_number":"EMA/626777/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2015-ema-decision-30-october-2015-agreement-paediatric-investigation-plan-granting-deferral-fluciclovine-18f-emea-001644-pip02-14_en.pdf"},
    {"id":"31606","name":"P/0163/2016: EMA decision of 15 June 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for imipenem\n\n(monohydrate) / cilastatin (sodium) / relebactam (MK-7655A), (EMEA-001809-PIP0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/337482/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2016-ema-decision-15-june-2016-agreement-paediatric-investigation-plan-granting-deferral-imipenem-monohydrate-cilastatin-sodium-relebactam-mk-7655a-emea-001809-pip0_en.pdf"},
    {"id":"31630","name":"P/0338/2016: EMA decision of 2 December 2016 on the refusal of a paediatric investigation plan and on the refusal of a waiver for derivative of 4Hpyrazolo[\n\n3,4-d]pyrimidin-4-one (EMEA-001742-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/757989/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0338-2016-ema-decision-2-december-2016-refusal-paediatric-investigation-plan-refusal-waiver-derivative-4hpyrazolo-34-dpyrimidin-4-one-emea-001742-pip02-16_en.pdf"},
    {"id":"31667","name":"P/0106/2017: EMA decision of 11 April 2017 on the agreement of a paediatric investigation plan for human fibrinogen concentrate (BT524) (EMEA-\n\n001931-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/166793/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2017-ema-decision-11-april-2017-agreement-paediatric-investigation-plan-human-fibrinogen-concentrate-bt524-emea-001931-pip01-16_en.pdf"},
    {"id":"31669","name":"P/0149/2014: EMA decision of 13 June 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for adeno-associated viral vector serotype 9 containing huma...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-18T02:00:00Z","last_updated_date":"2014-07-18T02:00:00Z","reference_number":"EMA/330057/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2014-ema-decision-13-june-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-adeno-associated-viral-vector-serotype-9-containing-huma_en.pdf"},
    {"id":"31675","name":"P/0301/2013: EMA decision of 29 November 2013 on the granting of a product specific waiver for odanacatib / colecalciferol (EMEA-001499-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/659494/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0301-2013-ema-decision-29-november-2013-granting-product-specific-waiver-odanacatib-colecalciferol-emea-001499-pip01-13_en.pdf"},
    {"id":"31681","name":"P/0094/2014: EMA decision of 7 April 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chimeric anti-disialoganglioside (GD2) monoclonal antibo...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/182153/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2014-ema-decision-7-april-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chimeric-anti-disialoganglioside-gd2-monoclonal-antibo_en.pdf"},
    {"id":"31726","name":"P/0093/2014: EMA decision of 7 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy) (EMEA-000117-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/186565/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0093-2014-ema-decision-7-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip02-10-m03_en.pdf"},
    {"id":"31732","name":"P/0177/2013: EMA decision of 30 July 2013 on the refusal of a product-specific waiver for esketamine (EMEA-001428-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/419089/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2013-ema-decision-30-july-2013-refusal-product-specific-waiver-esketamine-emea-001428-pip01-13_en.pdf"},
    {"id":"31743","name":"P/0054/2015: EMA decision of 9 March 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for ceftriaxone / sulbactam (EMEA-001568-PIP03-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-24T01:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/114881/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0054-2015-ema-decision-9-march-2015-agreement-paediatric-investigation-plan-granting-deferral-ceftriaxone-sulbactam-emea-001568-pip03-14_en.pdf"},
    {"id":"31744","name":"P/115/2011: EMA decision of 6 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab,\n\n(EMEA-000060-PIP02-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/314974/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-115-2011-ema-decision-6-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-canakinumab-emea-000060-pip02-08-m02_en.pdf"},
    {"id":"31772","name":"P/0163/2013: EMA decision of 29 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban\n\n(Xarelto), (EMEA-000430-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/393010/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2013-ema-decision-29-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m04_en.pdf"},
    {"id":"31778","name":"P/0195/2014: EMA decision of 8 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tofacitinib (EMEA-000576-PIP03-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/392211/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2014-ema-decision-8-august-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tofacitinib-emea-000576-pip03-12_en.pdf"},
    {"id":"31795","name":"P/154/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for paliperidone /\n\npaliperidone palmitate (Invega) ( EMEA-000014-PIP01-07-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/417965/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-154-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-paliperidone-paliperidone-palmitate-invega-emea-000014-pip01-07-m06_en.pdf"},
    {"id":"31824","name":"P/0013/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for selepressin (EMEA-000506-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1366/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-selepressin-emea-000506-pip01-08-m01_en.pdf"},
    {"id":"31834","name":"P/45/2009: European Medicines Agency decision of 24 March 2009 on the agreement of a Paediatric Investigation Plan and on the refusal of a deferral and on the granting of a waiver for glucose monohydrate (EMEA-000221-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/161418/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-45-2009-european-medicines-agency-decision-24-march-2009-agreement-paediatric-investigation-plan-refusal-deferral-granting-waiver-glucose-monohydrate-emea-000221-pip_en.pdf"},
    {"id":"31836","name":"P/42/2012: EMA decision of 28 February 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins (Xeomin, B...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/128416/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-42-2012-ema-decision-28-february-2012-agreement-paediatric-investigation-plan-granting-waiver-clostridium-botulinum-neurotoxin-type-150-kd-free-complexing-proteins-xeomin-b_en.pdf"},
    {"id":"31848","name":"P/114/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for sitagliptin phosphate monohydrate, metformin hydrochloride (Janumet)\n\nEMEA-000165-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/625238/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-114-2008-european-medicines-agency-decision-1-december-2008-application-agreement-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-metformin-hydrochloride-janumet-emea-000165_en.pdf"},
    {"id":"31853","name":"P/0154/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation factor VIII / von Willebrand factor (EMEA-000312-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/477564/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-emea-000312-pip01-08-m04_en.pdf"},
    {"id":"31868","name":"P/0319/2014: EMA decision of 19 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000454-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/719221/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0319-2014-ema-decision-19-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000454-pip01-08-m05_en.pdf"},
    {"id":"31873","name":"P/0059/2015: EMA decision of 1 April 2015 on the refusal of a modification of an agreed paediatric investigation plan for treprostinil (Remodulin and associated names) (EMEA-000207-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-04-24T02:00:00Z","last_updated_date":"2015-04-24T02:00:00Z","reference_number":"EMA/111310/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0059-2015-ema-decision-1-april-2015-refusal-modification-agreed-paediatric-investigation-plan-treprostinil-remodulin-associated-names-emea-000207-pip01-08-m05_en.pdf"},
    {"id":"31883","name":"P/0242/2016: EMA decision of 9 September 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for autologous cartilage derived cultured chondrocytes ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/536150/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2016-ema-decision-9-september-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-cartilage-derived-cultured-chondrocytes_en.pdf"},
    {"id":"31932","name":"P/0211/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin (Jardiance), (EMEA-000828-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/578688/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-empagliflozin-jardiance-emea-000828-pip01-09-m04_en.pdf"},
    {"id":"31940","name":"P/0228/2014: EMA decision of 5 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for N. meningitidis serogroup A, C, W and Y polysaccharide conjugated to tetanus toxoid / N. to...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/464768/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0228-2014-ema-decision-5-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-n-meningitidis-serogroup-c-w-y-polysaccharide-conjugated-tetanus-toxoid-n_en.pdf"},
    {"id":"31948","name":"P/128/2008: European Medicines Agency decision of 23 December 2008 on the application for product specific waiver for eprotirome (EMEA-000255-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/671590/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-128-2008-european-medicines-agency-decision-23-december-2008-application-product-specific-waiver-eprotirome-emea-000255-pip01-08-accordance-regulation-ec-no-1901-2006-european-parl_en.pdf"},
    {"id":"31962","name":"P/0328/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for migalastat (hydrochloride) (Galafold), (EMEA-001194-PIP01-11-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T11:35:00Z","last_updated_date":"2017-02-03T11:35:00Z","reference_number":"EMA/741988/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0328-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-migalastat-hydrochloride-galafold-emea-001194-pip01-11-m02_en.pdf"},
    {"id":"31965","name":"P/0126/2013: EMA decision of 28 May 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benralizumab (EMEA-001214-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/248952/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0126-2013-ema-decision-28-may-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-benralizumab-emea-001214-pip01-11_en.pdf"},
    {"id":"31992","name":"P/183/201: EMA decision of 4 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia) (EMEA-000018-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/589982/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-183-201-ema-decision-4-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-emea-000018-pip01-07-m03_en.pdf"},
    {"id":"31994","name":"P/0143/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000775-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/382957/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000775-pip01-09-m02_en.pdf"},
    {"id":"32011","name":"P/0326/2014: EMA decision of 22 December 2014 on the agreement of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for mepolizumab (EMEA-000069-PIP04-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/755906/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0326-2014-ema-decision-22-december-2014-agreement-paediatric-investigation-plan-refusal-deferral-granting-waiver-mepolizumab-emea-000069-pip04-13_en.pdf"},
    {"id":"32031","name":"P/0096/2016: EMA decision of 26 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Alipza and associated names) (EMEA-000300-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/195518/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0096-2016-ema-decision-26-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-alipza-associated-names-emea-000300-pip01-08-m04_en.pdf"},
    {"id":"32056","name":"P/0087/2012: EMA decision of 25 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for macitentan (EMEA-001032-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/339546/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0087-2012-ema-decision-25-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-macitentan-emea-001032-pip01-10-m01_en.pdf"},
    {"id":"32075","name":"P/0049/2014: European Medicines Agency decision of 7 March 2014 on the granting of a product specific waiver for ocriplasmin (Jetrea) (EMEA-000986-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/43438/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2014-european-medicines-agency-decision-7-march-2014-granting-product-specific-waiver-ocriplasmin-jetrea-emea-000986-pip02-13_en.pdf"},
    {"id":"32080","name":"P/0026/2013: EMA decision of 26 February 2013 on the granting of a product specific waiver for aztreonam (Cayston), (EMEA-000827-PIP03-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/75621/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0026-2013-ema-decision-26-february-2013-granting-product-specific-waiver-aztreonam-cayston-emea-000827-pip03-11_en.pdf"},
    {"id":"32092","name":"P/108/2011: EMA decision of 6 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for tadalafil (Adcirca, Cialis), (EMEA-000452-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/343619/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-108-2011-ema-decision-6-may-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tadalafil-adcirca-cialis-emea-000452-pip02-10_en.pdf"},
    {"id":"32110","name":"P/0166/2016: EMA decision of 15 June 2016 on the granting of a product specific waiver for olmesartan (medoxomil) / rosuvastatin (calcium)\n\n(EMEA-001914-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/314198/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2016-ema-decision-15-june-2016-granting-product-specific-waiver-olmesartan-medoxomil-rosuvastatin-calcium-emea-001914-pip01-15_en.pdf"},
    {"id":"32135","name":"P/0244/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for melatonin (Circadin), (EMEA-000440-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/617371/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0244-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-melatonin-circadin-emea-000440-pip02-11-m03_en.pdf"},
    {"id":"32142","name":"P/0283/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (EMEA-001214-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/689612/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0283-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-emea-001214-pip01-11-m04_en.pdf"},
    {"id":"32145","name":"20/2011: EMA decision of 25 January 2011 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for alogliptin benzoate (EMEA-000496-PIP01-08-M01) in accorda...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/28395/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/20-2011-ema-decision-25-january-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-alogliptin-benzoate-emea-000496-pip01-08-m01-accorda_en.pdf"},
    {"id":"32225","name":"P/0142/2012: EMA decision of 23 July 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for ethanol (EMEA-000414-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T17:15:00Z","last_updated_date":"2012-08-22T17:15:00Z","reference_number":"EMA/394700/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2012-ema-decision-23-july-2012-agreement-paediatric-investigation-plan-granting-waiver-ethanol-emea-000414-pip02-11_en.pdf"},
    {"id":"32234","name":"P/187/2010: European Medicines Agency decision of 24 September 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant human monoclonal a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/585817/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-187-2010-european-medicines-agency-decision-24-september-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-monoclonal_en.pdf"},
    {"id":"32253","name":"P/0159/2014: EMA decision of 18 June 2014 on the granting of a product specific waiver for pantoprazole (in combination with amoxicillin + clarithromycin + metronidazole) (EMEA-001616-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T11:45:00Z","last_updated_date":"2014-07-22T11:45:00Z","reference_number":"EMA/259622/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2014-ema-decision-18-june-2014-granting-product-specific-waiver-pantoprazole-combination-amoxicillin-clarithromycin-metronidazole-emea-001616-pip01-13_en.pdf"},
    {"id":"32256","name":"P/238/2009: European Medicines Agency descion of 1 December 2009on the acceptance of a modification of an agreed Paediatric Investigation Plan for canakinumab (EMEA-000060-PIP02-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-08T01:00:00Z","last_updated_date":"2010-12-08T01:00:00Z","reference_number":"EMEA/760824/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-238-2009-european-medicines-agency-descion-1-december-2009on-acceptance-modification-agreed-paediatric-investigation-plan-canakinumab-emea-000060-pip02-08-m01_en.pdf"},
    {"id":"32268","name":"P/0102/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for quizartinib (EMEA-\n\n001821-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/145135/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-quizartinib-emea-001821-pip01-15-m01_en.pdf"},
    {"id":"32283","name":"P/0171/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen / human thrombin (Evicel, Evarrest), (EMEA-001149-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/434441/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-human-thrombin-evicel-evarrest-emea-001149-pip01-11-m02_en.pdf"},
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    {"id":"32291","name":"P/209/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral for Lasparaginase encapsulated in erythrocytes, (EMEA-000341-PIP02-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/656412/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-209-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-lasparaginase-encapsulated-erythrocytes-emea-000341-pip02-0_en.pdf"},
    {"id":"32300","name":"P/0202/2015: EMA decision of 4 September 2015 on the granting of a product specific waiver for amlodipine / perindopril (tert-butylamine) / rosuvastatin (EMEA-001772-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/568912/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0202-2015-ema-decision-4-september-2015-granting-product-specific-waiver-amlodipine-perindopril-tert-butylamine-rosuvastatin-emea-001772-pip01-15_en.pdf"},
    {"id":"32324","name":"P/0146/2013: EMA decision of 3 July 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for estetrol /\n\ndrospirenone (EMEA-001332-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-09T16:30:00Z","last_updated_date":"2013-08-09T16:30:00Z","reference_number":"EMA/311599/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0146-2013-ema-decision-3-july-2013-agreement-paediatric-investigation-plan-granting-waiver-estetrol-drospirenone-emea-001332-pip01-12_en.pdf"},
    {"id":"32331","name":"P/0123/2013: EMA decision of 28 May 2013 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia), (EMEA-000470-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-21T13:30:00Z","last_updated_date":"2013-06-21T13:30:00Z","reference_number":"EMA/245786/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2013-ema-decision-28-may-2013-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-januvia-emea-000470-pip01-08-m07_en.pdf"},
    {"id":"32339","name":"P/0199/2017: EMA decision of 14 July 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for Fc- and CDRmodified\n\nhumanised monoclonal antibody against C5 (EMEA-002077-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/434826/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2017-ema-decision-14-july-2017-agreement-paediatric-investigation-plan-granting-deferral-fc-cdrmodified-humanised-monoclonal-antibody-against-c5-emea-002077-pip01-16_en.pdf"},
    {"id":"32348","name":"P/0034/2013: EMA decision of 26 February 2013 on the granting of a product-specific waiver for amlodipine (besylate) / atorvastatin (calcium), (EMEA-001364-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T16:00:00Z","last_updated_date":"2013-04-23T16:00:00Z","reference_number":"EMA/23839/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2013-ema-decision-26-february-2013-granting-product-specific-waiver-amlodipine-besylate-atorvastatin-calcium-emea-001364-pip01-12_en.pdf"},
    {"id":"32383","name":"P/0295/2012: EMA decision of 18 December 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for chimeric anti-disialoganglioside (GD2) monoclonal antibody (NSC764038) (EMEA-001285-PI...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T14:00:00Z","last_updated_date":"2013-02-08T14:00:00Z","reference_number":"EMA/802482/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2012-ema-decision-18-december-2012-agreement-paediatric-investigation-plan-granting-waiver-chimeric-anti-disialoganglioside-gd2-monoclonal-antibody-nsc764038-emea-001285-pi_en.pdf"},
    {"id":"32384","name":"P/0349/2017: EMA decision of 1 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ruxolitinib (phosphate) (Jakavi), (EMEA-000901-PIP03...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/723538/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0349-2017-ema-decision-1-december-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ruxolitinib-phosphate-jakavi-emea-000901-pip03_en.pdf"},
    {"id":"32405","name":"P/170/2009: European Medicines Agency decision of 28 August 2009 on the granting of a product specific waiver for sitagliptin phosphate monohydrate / simvastatin (EMEA-000536-PIP01-09) in accordance with Regulation (EC) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/531540/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-170-2009-european-medicines-agency-decision-28-august-2009-granting-product-specific-waiver-sitagliptin-phosphate-monohydrate-simvastatin-emea-000536-pip01-09-accordance-regulation-ec_en.pdf"},
    {"id":"32413","name":"P/0232/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for lanthanum carbonate hydrate (Fosrenol and associated names), (EMEA-000637-PIP02-10-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/579872/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2016-ema-decision-9-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-lanthanum-carbonate-hydrate-fosrenol-associated-names-emea-000637-pip02-10-m05_en.pdf"},
    {"id":"32429","name":"P/0357/2016: EMA decision of 21 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for deferiprone (EMEA-\n\n001126-PIP01-10-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T11:35:00Z","last_updated_date":"2017-02-03T11:35:00Z","reference_number":"EMA/788574/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0357-2016-ema-decision-21-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-deferiprone-emea-001126-pip01-10-m02_en.pdf"},
    {"id":"32434","name":"P/0085/2017: EMA decision of 17 March 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for baclofen (EMEA-001549-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/165668/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0085-2017-ema-decision-17-march-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-baclofen-emea-001549-pip02-14_en.pdf"},
    {"id":"32485","name":"P/0207/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for turoctocog alfa\n\n(NovoEight) (EMEA-000428-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/441051/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-turoctocog-alfa-novoeight-emea-000428-pip01-08-m03_en.pdf"},
    {"id":"32491","name":"P/0073/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for retosiban (EMEA-001359-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/156141/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-retosiban-emea-001359-pip01-12-m01_en.pdf"},
    {"id":"32494","name":"P/0133/2014: EMA decision of 10 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ceftazidime / avibactam (EMEA-001313-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-28T02:00:00Z","last_updated_date":"2014-07-28T02:00:00Z","reference_number":"EMA/268696/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0133-2014-ema-decision-10-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-ceftazidime-avibactam-emea-001313-pip01-12-m01_en.pdf"},
    {"id":"32495","name":"P/0196/2017: EMA decision of 14 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis),\n\n(EMEA-000183-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-29T02:00:00Z","last_updated_date":"2017-09-29T02:00:00Z","reference_number":"EMA/430856/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2017-ema-decision-14-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip01-08-m05_en.pdf"},
    {"id":"32511","name":"P/0184/2014: EMA decision of 6 August 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for tobramycin (TOBI), (EMEA-000184-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/414809/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2014-ema-decision-6-august-2014-agreement-paediatric-investigation-plan-granting-waiver-tobramycin-tobi-emea-000184-pip02-14_en.pdf"},
    {"id":"32537","name":"P/0311/2014: EMA decision of 25 November 2014 on the granting of a product specific waiver for diclofenac sodium / thiocolchicoside (EMEA-001558-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/643639/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0311-2014-ema-decision-25-november-2014-granting-product-specific-waiver-diclofenac-sodium-thiocolchicoside-emea-001558-pip02-14_en.pdf"},
    {"id":"32577","name":"P/0309/2012: EMA decision of 21 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for empagliflozin (EMEA-000828-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-07T13:30:00Z","last_updated_date":"2013-02-07T13:30:00Z","reference_number":"EMA/809327/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0309-2012-ema-decision-21-december-2012-acceptance-modification-agreed-paediatric-investigation-plan-empagliflozin-emea-000828-pip01-09-m01_en.pdf"},
    {"id":"32583","name":"P/297/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for anidulafungin\n\n(Ecalta), (EMEA-000469-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/944542/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-297-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-anidulafungin-ecalta-emea-000469-pip01-08-m03_en.pdf"},
    {"id":"32599","name":"P/314/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass and rye pollen (50...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769459/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-314-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-rye-pollen-50_en.pdf"},
    {"id":"32601","name":"P/0227/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for lonoctocog alfa (EMEA-001215-PIP01-11-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/619901/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-lonoctocog-alfa-emea-001215-pip01-11-m04_en.pdf"},
    {"id":"32628","name":"P/0379/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for vosoritide\n\n(BMN 111) (EMEA-002033-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/759547/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0379-2017-ema-decision-19-december-2017-agreement-paediatric-investigation-plan-granting-deferral-vosoritide-bmn-111-emea-002033-pip01-16_en.pdf"},
    {"id":"32634","name":"P/0341/2014: EMA decision of 22 December 2014 on the granting of a product specific waiver for calcium (carbonate) / cholecalciferol (in combination with ibandronic acid) (EMEA-001670-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/713537/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0341-2014-ema-decision-22-december-2014-granting-product-specific-waiver-calcium-carbonate-cholecalciferol-combination-ibandronic-acid-emea-001670-pip01-14_en.pdf"},
    {"id":"32642","name":"P/0015/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (Entyvio), (EMEA-000645-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/1372/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-vedolizumab-entyvio-emea-000645-pip01-09-m03_en.pdf"},
    {"id":"32666","name":"P/0210/2015: EMA decision of 2 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-23T16:00:00Z","last_updated_date":"2015-11-23T16:00:00Z","reference_number":"EMA/568205/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2015-ema-decision-2-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-azilsartan-medoxomil-edarbi-emea-000237-pip01-08-m06_en.pdf"},
    {"id":"32669","name":"P/101/2010: European Medicines Agency decision of 4 June 2010\n\non the acceptance of a modification of an agreed paediatric investigation plan for rabeprazole (sodium) (Pariet and associated names) (EMEA-000055-PIP01-07-M...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/354482/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-101-2010-european-medicines-agency-decision-4-june-2010-acceptance-modification-agreed-paediatric-investigation-plan-rabeprazole-sodium-pariet-associated-names-emea-000055-pip01-07-m_en.pdf"},
    {"id":"32686","name":"P/0231/2012: EMA decision of 5 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pitavastatin (calcium) (Alipza and associated names), (EMEA-000300-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/625279/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2012-ema-decision-5-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-pitavastatin-calcium-alipza-associated-names-emea-000300-pip01-08-m03_en.pdf"},
    {"id":"32691","name":"P/261/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver mixture of Phleum pratense, Dactylis glomerata, Festuca e...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/710663/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-261-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mixture-phleum-pratense-dactylis-glomerata-festuca-e_en.pdf"},
    {"id":"32709","name":"P/0071/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan and on the refusal of a waiver for autologous CD34+ cells transduced ex-vivo with retroviral Vector (GIADAl) containing human...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/113454/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0071-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-refusal-waiver-autologous-cd34-cells-transduced-ex-vivo-retroviral-vector-giadal-containing-human_en.pdf"},
    {"id":"32721","name":"P/0013/2012: EMA decision of 24 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for treprostinil\n\n(diethanolamine) (EMEA-001165-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/13957/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2012-ema-decision-24-january-2012-agreement-paediatric-investigation-plan-granting-deferral-treprostinil-diethanolamine-emea-001165-pip01-11_en.pdf"},
    {"id":"32742","name":"P/0211/2013: EMA decision of 3 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for thrombomodulin alfa (EMEA-001363-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/483101/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2013-ema-decision-3-september-2013-agreement-paediatric-investigation-plan-granting-deferral-thrombomodulin-alfa-emea-001363-pip01-12_en.pdf"},
    {"id":"32756","name":"P/0218/2015: EMA decision of 2 October 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for acotiamide (EMEA-001461-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-11-19T01:00:00Z","last_updated_date":"2015-11-19T01:00:00Z","reference_number":"EMA/561659/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2015-ema-decision-2-october-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-acotiamide-emea-001461-pip02-14_en.pdf"},
    {"id":"32763","name":"P/0077/2017: EMA decision of 17 March 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector e...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/104958/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2017-ema-decision-17-march-2017-agreement-paediatric-investigation-plan-granting-waiver-autologous-cd34-hematopoietic-stem-cells-transduced-ex-vivo-efs-lentiviral-vector-e_en.pdf"},
    {"id":"32787","name":"P/0097/2012: EMA decision of 30 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/331076/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2012-ema-decision-30-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-bosentan-tracleer-emea-000425-pip02-10-m02_en.pdf"},
    {"id":"32803","name":"P/0174/2012: EMA decision of 27 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for migalastat (hydrochloride) (EMEA-001194-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T16:00:00Z","last_updated_date":"2012-08-23T16:00:00Z","reference_number":"EMA/492342/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2012-ema-decision-27-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-migalastat-hydrochloride-emea-001194-pip01-11_en.pdf"},
    {"id":"32819","name":"P/158/201: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab\n\n(XGEVA, previously Amgiva and Prolia) (EMEA-000145-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/424850/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-158-201-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-xgeva-previously-amgiva-prolia-emea-000145-pip01-07-m03_en.pdf"},
    {"id":"32832","name":"P/110/2011: EMA decision of 6 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for linaclotide (EMEA-000927-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/334962/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-110-2011-ema-decision-6-may-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-linaclotide-emea-000927-pip01-10_en.pdf"},
    {"id":"32876","name":"P/0141/2016: EMA decision of 20 May 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897) (EMEA-001784-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/287537/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2016-ema-decision-20-may-2016-agreement-paediatric-investigation-plan-granting-waiver-anti-respiratory-syncytial-virus-human-igg1io-monoclonal-antibody-medi8897-emea-001784-p_en.pdf"},
    {"id":"32879","name":"P/310/2011: EMA decision of 20 December 2011 on the granting of a product specific waiver for insulin degludec / liraglutide (EMEA-001193-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/944182/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-310-2011-ema-decision-20-december-2011-granting-product-specific-waiver-insulin-degludec-liraglutide-emea-001193-pip01-11_en.pdf"},
    {"id":"32914","name":"P/163/2009: European Medicines Agency decision of 12 August 2009 on the granting of a product specific waiver for patupilone (EMEA-000557-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the European Parliame...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/489978/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-163-2009-european-medicines-agency-decision-12-august-2009-granting-product-specific-waiver-patupilone-emea-000557-pip01-09-accordance-regulation-ec-no-1901-2006-european-parliame_en.pdf"},
    {"id":"32931","name":"P/0152/2014: EMA decision of 13 June 2014 on the granting of a product specific waiver for (11beta,17beta)-17-hydroxy-11-[4-(methylsulfonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one (EMEA-001576-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/275214/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2014-ema-decision-13-june-2014-granting-product-specific-waiver-11beta17beta-17-hydroxy-11-4-methylsulfonylphenyl-17-pentafluoroethylestra-49-dien-3-one-emea-001576-pip01-13_en.pdf"},
    {"id":"32940","name":"P/0177/2016: EMA decision of 8 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for eleclazine\n\n(EMEA-001697-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-19T02:00:00Z","last_updated_date":"2016-09-19T02:00:00Z","reference_number":"EMA/408698/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2016-ema-decision-8-july-2016-agreement-paediatric-investigation-plan-granting-deferral-eleclazine-emea-001697-pip01-14_en.pdf"},
    {"id":"32965","name":"P/0039/2017: European Medicines Agency decision of 31 January 2017 on the granting of a product specific waiver for (2-Hydroxyethyl)trimethylammonium 3-[2-fluoro-5-(2,3-difluoro-6-methoxybenzyloxy)-4- methoxyphenyl]-2,4-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/12260/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0039-2017-european-medicines-agency-decision-31-january-2017-granting-product-specific-waiver-2-hydroxyethyltrimethylammonium-3-2-fluoro-5-23-difluoro-6-methoxybenzyloxy-4-methoxyphenyl-24_en.pdf"},
    {"id":"32978","name":"P/0107/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab\n\n(Fasenra), (EMEA-001214-PIP01-11-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/151867/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0107-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-fasenra-emea-001214-pip01-11-m07_en.pdf"},
    {"id":"32991","name":"P/0028/2017: EMA decision of 10 February 2017 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine /\n\ndolutegravir (EMEA-001750-PIP01-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-18T02:00:00Z","last_updated_date":"2017-04-18T02:00:00Z","reference_number":"EMA/2926/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2017-ema-decision-10-february-2017-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-dolutegravir-emea-001750-pip01-15-m01_en.pdf"},
    {"id":"32994","name":"P/0007/2013: EMA decision of 21 January 2013 on the granting of a product-specific waiver for morphine / oxycodone (EMEA-001281-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T14:30:00Z","last_updated_date":"2013-04-03T14:30:00Z","reference_number":"EMA/779528/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2013-ema-decision-21-january-2013-granting-product-specific-waiver-morphine-oxycodone-emea-001281-pip01-12_en.pdf"},
    {"id":"33032","name":"P/0219/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for luspatercept (EMEA-\n\n001521-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/430903/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-luspatercept-emea-001521-pip01-13-m01_en.pdf"},
    {"id":"33034","name":"P/0139/2016: EMA decision of 20 May 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for doravirine (EMEA-001676-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-18T02:00:00Z","last_updated_date":"2016-07-18T02:00:00Z","reference_number":"EMA/290659/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2016-ema-decision-20-may-2016-agreement-paediatric-investigation-plan-granting-deferral-doravirine-emea-001676-pip01-14_en.pdf"},
    {"id":"33038","name":"P/174/2010: European Medicines Agency decision of 20 September 2010 on the acceptance of a modification of an agreed paediatric investigation plan for retigabine (EMEA-000116-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/582666/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-174-2010-european-medicines-agency-decision-20-september-2010-acceptance-modification-agreed-paediatric-investigation-plan-retigabine-emea-000116-pip01-07-m03_en.pdf"},
    {"id":"33059","name":"P/282/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for allergen extract of secale cereale pollen (EMEA-00091...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-11T01:00:00Z","last_updated_date":"2011-01-11T01:00:00Z","reference_number":"EMA/754285/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-282-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-allergen-extract-secale-cereale-pollen-emea-00091_en.pdf"},
    {"id":"33074","name":"P/0329/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for autologous\n\nhaematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T11:35:00Z","last_updated_date":"2017-02-03T11:35:00Z","reference_number":"EMA/765280/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0329-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-autologous-haematopoietic-stem-cells-transduced-lentiviral-vector-lenti-d-encoding_en.pdf"},
    {"id":"33075","name":"P/0019/2013: EMA decision of 1 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for solifenacin (succinate) (Vesicare and associated names), (EMEA-000573-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/49423/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2013-ema-decision-1-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-solifenacin-succinate-vesicare-associated-names-emea-000573-pip01-09-m02_en.pdf"},
    {"id":"33083","name":"P/191/2009: Modification of a PIP for alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, pr...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/610520/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-191-2009-modification-pip-alanine-arginine-aspartic-acid-cysteine-cystine-glutamic-acid-glycine-histidine-isoleucine-leucine-lysine-monohydrate-methionine-ornithine-hydrochloride-phenylalanine-pr_en.pdf"},
    {"id":"33085","name":"P/0094/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for treprostinil (sodium) (EMEA-002254-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/100876/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2018-ema-decision-16-march-2018-granting-product-specific-waiver-treprostinil-sodium-emea-002254-pip01-17_en.pdf"},
    {"id":"33097","name":"P/0098/2012: EMA decision of 30 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine (hydrochloride) (Corlentor), (EMEA-000627-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/273382/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0098-2012-ema-decision-30-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-corlentor-emea-000627-pip01-09-m03_en.pdf"},
    {"id":"33103","name":"P/83/2011: EMA decision of 6 April 2011 on the refusal of a product specific waiver for aciclovir (EMEA-001066-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/249985/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-83-2011-ema-decision-6-april-2011-refusal-product-specific-waiver-aciclovir-emea-001066-pip01-10_en.pdf"},
    {"id":"33128","name":"P/0053/2018: EMA decision of 1 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium\n\ncyclosilicate (EMEA-001539-PIP01-13-M03) (Lokelma was authorised after the De...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/91846/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2018-ema-decision-1-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-sodium-zirconium-cyclosilicate-emea-001539-pip01-13-m03-lokelma-was-authorised-after-de_en.pdf"},
    {"id":"33147","name":"P/0342/2016: EMA decision of 2 December 2016 on the agreement of a paediatric investigation plan for recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689) (EMEA-001886-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-27T01:00:00Z","last_updated_date":"2017-01-27T01:00:00Z","reference_number":"EMA/758312/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0342-2016-ema-decision-2-december-2016-agreement-paediatric-investigation-plan-recombinant-fusion-protein-linking-coagulation-factor-viia-albumin-rviia-fp-csl689-emea-001886-pip01-15_en.pdf"},
    {"id":"33194","name":"P/196/2010: European Medicines Agency decision of 26 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for riociguat (EMEA-000718-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/651401/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-196-2010-european-medicines-agency-decision-26-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-riociguat-emea-000718-pip01-09_en.pdf"},
    {"id":"33212","name":"P/109/2009: European Medicines Agency decision of 16 June 2009 on the granting of a product specific waiver for clazosentan (EMEA-000369-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parliamen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351854/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-109-2009-european-medicines-agency-decision-16-june-2009-granting-product-specific-waiver-clazosentan-emea-000369-pip01-08-accordance-regulation-ec-no-1901-2006-european-parliamen_en.pdf"},
    {"id":"33239","name":"P/0291/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone\n\ndipropionate / formoterol fumarate dihydrate (Foster and associated names, K...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/647900/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0291-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-beclometasone-dipropionate-formoterol-fumarate-dihydrate-foster-associated-names-k_en.pdf"},
    {"id":"33299","name":"P/0103/2012: EMA decision of 30 May 2012 on the granting of a product specific waiver for glimepiride / atorvastatin (calcium), (EMEA-001232-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/274474/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0103-2012-ema-decision-30-may-2012-granting-product-specific-waiver-glimepiride-atorvastatin-calcium-emea-001232-pip01-11_en.pdf"},
    {"id":"33300","name":"P/0197/2017: EMA decision of 14 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for treosulfan (EMEA-000883-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/433425/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2017-ema-decision-14-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-treosulfan-emea-000883-pip01-10-m04_en.pdf"},
    {"id":"33334","name":"P/0225/2014: EMA decision of 5 September 2014 on the refusal of a modification of an agreed paediatric investigation plan for telaprevir (Incivo), (EMEA-000196-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/501714/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2014-ema-decision-5-september-2014-refusal-modification-agreed-paediatric-investigation-plan-telaprevir-incivo-emea-000196-pip01-08-m03_en.pdf"},
    {"id":"33364","name":"P/73/2008: European medicines agency decision of 14 September 2008\n\non the application for agreement of a Paediatric Investigation Plan for[d2] ezetimibe and simvastatin (fixed combination) (INEGY and associated trade na...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-10-10T02:00:00Z","last_updated_date":"2008-10-10T02:00:00Z","reference_number":"EMEA/467238/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-73-2008-european-medicines-agency-decision-14-september-2008-application-agreement-paediatric-investigation-plan-ford2-ezetimibe-simvastatin-fixed-combination-inegy-associated-trade-na_en.pdf"},
    {"id":"33397","name":"P/79/2011: EMA decision of 6 April 2011 on the granting of a product specific waiver for human normal immunoglobulin (EMEA-000558-PIP02-\n\n10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/248312/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-79-2011-ema-decision-6-april-2011-granting-product-specific-waiver-human-normal-immunoglobulin-emea-000558-pip02-10_en.pdf"},
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    {"id":"33529","name":"P/0077/2015: EMA decision of 1 April 2015 on the granting of a product-specific waiver for autologous bone marrow-derived cardiopoietic stem cells (EMEA-001694-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/108893/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2015-ema-decision-1-april-2015-granting-product-specific-waiver-autologous-bone-marrow-derived-cardiopoietic-stem-cells-emea-001694-pip01-14_en.pdf"},
    {"id":"33531","name":"P/0074/2012: EMA decision of 25 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil\n\n(Remodulin and associated names), (EMEA-000207-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/255881/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2012-ema-decision-25-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-treprostinil-remodulin-associated-names-emea-000207-pip01-08-m02_en.pdf"},
    {"id":"33550","name":"P/139/2010:  European Medicines Agency decision of 30 July 2010 on the granting of a product specific waiver for dexamethasone (EMEA-000198-PIP04-10) in accordance with Regulation (EC) No 1901/2006 of the European Parlia...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/425487/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-139-2010-european-medicines-agency-decision-30-july-2010-granting-product-specific-waiver-dexamethasone-emea-000198-pip04-10-accordance-regulation-ec-no-1901-2006-european-parlia_en.pdf"},
    {"id":"33607","name":"P/0074/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for etelcalcetide (EMEA-001554-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/104835/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-etelcalcetide-emea-001554-pip01-13-m01_en.pdf"},
    {"id":"33608","name":"P/0230/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion\n\nprotein linking human coagulation factor IX with human albumin (Albutrepen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/434833/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-linking-human-coagulation-factor-ix-human-albumin-albutrepen_en.pdf"},
    {"id":"33637","name":"P/0084/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human normal immunoglobulin (EMEA-001797-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/104853/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-normal-immunoglobulin-emea-001797-pip01-15_en.pdf"},
    {"id":"33639","name":"P/84/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for lubiprostone (EMEA-000245-PIP01-08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/258610/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-84-2011-ema-decision-8-april-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lubiprostone-emea-000245-pip01-08_en.pdf"},
    {"id":"33659","name":"P/0235/2016: EMA decision of 9 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for evolocumab\n\n(Repatha) (EMEA-001268-PIP01-12-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/579793/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2016-ema-decision-9-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-evolocumab-repatha-emea-001268-pip01-12-m03_en.pdf"},
    {"id":"33669","name":"P/0259/2013: EMA decision of 29 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for octocog alfa (EMEA-001064-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/601910/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2013-ema-decision-29-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-octocog-alfa-emea-001064-pip01-10-m01_en.pdf"},
    {"id":"33725","name":"P/238/2010:  EMA decision of 12 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for teduglutide, (EMEA-000482-PIP01-08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/672693/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-238-2010-ema-decision-12-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-teduglutide-emea-000482-pip01-08_en.pdf"},
    {"id":"33752","name":"P/0086/2016: EMA decision of 18 March 2016 on the granting of a product specific waiver for recombinant human monoclonal antibody against growth differentiation factor 8 (REGN1033) (EMEA-001859-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/107873/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0086-2016-ema-decision-18-march-2016-granting-product-specific-waiver-recombinant-human-monoclonal-antibody-against-growth-differentiation-factor-8-regn1033-emea-001859-pip02-15_en.pdf"},
    {"id":"33765","name":"P/0004/2017: EMA decision of 13 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo),\n\n(EMEA-001407-PIP02-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/8040/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0004-2017-ema-decision-13-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-nivolumab-opdivo-emea-001407-pip02-15-m01_en.pdf"},
    {"id":"33769","name":"P/69/2010: European Medicines Agency decision on the granting of a product specific waiver for forodesine hydrochloride (EMEA-000785-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/265315/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-69-2010-european-medicines-agency-decision-granting-product-specific-waiver-forodesine-hydrochloride-emea-000785-pip01-09_en.pdf"},
    {"id":"33776","name":"P/0196/2015: EMA decision of 4 September 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for raxibacumab (EMEA-001569-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/571294/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0196-2015-ema-decision-4-september-2015-agreement-paediatric-investigation-plan-granting-deferral-raxibacumab-emea-001569-pip01-13_en.pdf"},
    {"id":"33778","name":"P/44/2011: EMA decision of 3 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for telcagepant (EMEA-000274-PIP01-08-M01) in accordance with Regulation (EC) No 1901/2006 of the Eur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2011-04-05T02:00:00Z","reference_number":"EMA/115432/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-44-2011-ema-decision-3-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-telcagepant-emea-000274-pip01-08-m01-accordance-regulation-ec-no-1901-2006-eur_en.pdf"},
    {"id":"33785","name":"P/0293/2013: EMA decision of 29 November 2013 on the refusal of a modification of an agreed paediatric investigation plan for riociguat (EMEA-000718-\n\nPIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/693021/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0293-2013-ema-decision-29-november-2013-refusal-modification-agreed-paediatric-investigation-plan-riociguat-emea-000718-pip01-09-m03_en.pdf"},
    {"id":"33800","name":"P/0190/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / velpatasvir (Epclusa), (EMEA-001646-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/354122/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2017-ema-decision-3-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-sofosbuvir-velpatasvir-epclusa-emea-001646-pip01-14-m01_en.pdf"},
    {"id":"33846","name":"P/0151/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aprepitant (Emend), (EMEA-000144-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/475860/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-aprepitant-emend-emea-000144-pip01-07-m03_en.pdf"},
    {"id":"33862","name":"P/24/2009: European Medicines Agency decision of 23 February 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for drospirenone / ethinylestradiol bethadex clathrate, Yaz and associat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-04-23T02:00:00Z","last_updated_date":"2009-04-23T02:00:00Z","reference_number":"EMEA/95882/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-24-2009-european-medicines-agency-decision-23-february-2009-refusal-paediatric-investigation-plan-granting-waiver-drospirenone-ethinylestradiol-bethadex-clathrate-yaz-associat_en.pdf"},
    {"id":"33870","name":"P/0213/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for obeticholic acid\n\n(6 alpha-ethylchenodeoxycholic acid) (Ocaliva), (EMEA-001304-PIP02-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/430844/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-obeticholic-acid-6-alpha-ethylchenodeoxycholic-acid-ocaliva-emea-001304-pip02-13-m03_en.pdf"},
    {"id":"33893","name":"P/0137/2014: EMA decision of 11 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ cells transduced with lentiviral vector containing the human Wiskott Aldrich S...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-28T02:00:00Z","last_updated_date":"2014-07-28T02:00:00Z","reference_number":"EMA/273931/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2014-ema-decision-11-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-wiskott-aldrich-s_en.pdf"},
    {"id":"33910","name":"P/0200/2017: EMA decision of 21 July 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for liposomal combination of cytarabine and daunorubicin (EM...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/431300/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0200-2017-ema-decision-21-july-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-liposomal-combination-cytarabine-daunorubicin-em_en.pdf"},
    {"id":"33916","name":"P/0344/2017: EMA decision of 23 November 2017 on the acceptance of a modification of an agreed paediatric investigation plan for avacopan (EMEA-\n\n002023-PIP01-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/753000/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0344-2017-ema-decision-23-november-2017-acceptance-modification-agreed-paediatric-investigation-plan-avacopan-emea-002023-pip01-16-m02_en.pdf"},
    {"id":"33928","name":"P/0122/2017: EMA decision of 5 May 2017 on the granting of a product specific waiver for small interfering RNA targeting human TRPV1 mRNA\n\n(EMEA-002061-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/260021/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2017-ema-decision-5-may-2017-granting-product-specific-waiver-small-interfering-rna-targeting-human-trpv1-mrna-emea-002061-pip01-16_en.pdf"},
    {"id":"33936","name":"P/0080/2013: EMA decision of 27 March 2013 on the granting of a product-specific waiver for sialic acid (EMEA-001400-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/115012/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2013-ema-decision-27-march-2013-granting-product-specific-waiver-sialic-acid-emea-001400-pip01-12_en.pdf"},
    {"id":"33971","name":"P/0186/2014: EMA decision of 6 August 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for ranibizumab (Lucentis), (EMEA-000527-PIP04-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/416368/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2014-ema-decision-6-august-2014-agreement-paediatric-investigation-plan-granting-waiver-ranibizumab-lucentis-emea-000527-pip04-13_en.pdf"},
    {"id":"33987","name":"P/0272/2012: EMA decision of of 21 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for fingolimod (hydrochloride) (Gilenya), (EMEA-000087-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/722994/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0272-2012-ema-decision-21-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-fingolimod-hydrochloride-gilenya-emea-000087-pip01-07-m02_en.pdf"},
    {"id":"34009","name":"P/291/2010: EMA decision of 22 December 2010 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/773522/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-291-2010-ema-decision-22-december-2010-granting-product-specific-waiver-ranibizumab-lucentis-emea-000527-pip02-10_en.pdf"},
    {"id":"34010","name":"P/0210/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus\n\nsurface antigens (haemagglutinin (HA) and neuraminidase) (EMEA-000124-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/501330/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-ha-neuraminidase-emea-000124-pip_en.pdf"},
    {"id":"34048","name":"P/0112/2018: EMA decision of 11 April 2018 on the refusal of a modification of an agreed paediatric investigation plan for concentrate of\n\nproteolytic enzymes in bromelain (NexoBrid) (EMEA-000142-PIP02-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/197933/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0112-2018-ema-decision-11-april-2018-refusal-modification-agreed-paediatric-investigation-plan-concentrate-proteolytic-enzymes-bromelain-nexobrid-emea-000142-pip02-09-m06_en.pdf"},
    {"id":"34062","name":"P/0284/2012: EMA decision of 23 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for eslicarbazepine (acetate) (Zebinix), (EMEA-000696-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/717445/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0284-2012-ema-decision-23-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-eslicarbazepine-acetate-zebinix-emea-000696-pip02-10-m02_en.pdf"},
    {"id":"34081","name":"P/0204/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for asfotase alfa (EMEA-\n\n000987-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-29T02:00:00Z","last_updated_date":"2017-09-29T02:00:00Z","reference_number":"EMA/467048/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-asfotase-alfa-emea-000987-pip01-10-m03_en.pdf"},
    {"id":"34092","name":"P/0129/2014: EMA decision of 20 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec (Tresiba), (EMEA-000456-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-25T02:00:00Z","last_updated_date":"2014-06-25T02:00:00Z","reference_number":"EMA/279156/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2014-ema-decision-20-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-insulin-degludec-tresiba-emea-000456-pip01-08-m02_en.pdf"},
    {"id":"34095","name":"P/295/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for tiotropium bromide (monohydrate) (Spiriva Respimat and associated names, Spiriva) (EMEA-0000...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/944891/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-295-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-tiotropium-bromide-monohydrate-spiriva-respimat-associated-names-spiriva-emea-0000_en.pdf"},
    {"id":"34104","name":"P/0027/2014: EMA decision of 24 January 2014 on the refusal of a paediatric investigation plan and on the granting of a waiver for diclofenac / levomenthol (EMEA-001536-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/775576/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0027-2014-ema-decision-24-january-2014-refusal-paediatric-investigation-plan-granting-waiver-diclofenac-levomenthol-emea-001536-pip01-13_en.pdf"},
    {"id":"34124","name":"P/0215/2012: EMA decision of 28 September 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant single-chain coagulation factor VIII, (EMEA-001215-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T18:45:00Z","last_updated_date":"2012-10-17T18:45:00Z","reference_number":"EMA/611501/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2012-ema-decision-28-september-2012-agreement-paediatric-investigation-plan-granting-deferral-recombinant-single-chain-coagulation-factor-viii-emea-001215-pip01-11_en.pdf"},
    {"id":"34129","name":"P/0009/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir\n\n(sulphate) / cobicistat (Evotaz), (EMEA-001465-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/28175/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-atazanavir-sulphate-cobicistat-evotaz-emea-001465-pip01-13-m02_en.pdf"},
    {"id":"34138","name":"P/0277/2016: EMA decision of 5 October 2016 on the refusal of a product specific waiver for 18F fluoromisonidazole (EMEA-001977-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/593540/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0277-2016-ema-decision-5-october-2016-refusal-product-specific-waiver-18f-fluoromisonidazole-emea-001977-pip02-16_en.pdf"},
    {"id":"34149","name":"P/0287/2015: EMA decision of 26 November 2015 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for dimethyl fumarate (EMEA-001721-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-12-22T13:00:00Z","last_updated_date":"2015-12-22T13:00:00Z","reference_number":"EMA/690847/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0287-2015-ema-decision-26-november-2015-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-dimethyl-fumarate-emea-001721-pip01-14_en.pdf"},
    {"id":"34178","name":"P/0169/2014: EMA decision of 7 July 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (EMEA-001501-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-31T12:00:00Z","last_updated_date":"2014-07-31T12:00:00Z","reference_number":"EMA/393176/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2014-ema-decision-7-july-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dupilumab-emea-001501-pip01-13_en.pdf"},
    {"id":"34186","name":"P/99/2010: European Medicines Agency decision of 4 June 2010 on the  agreement of a paediatric investigation plan and on the granting of a waiver for anagrelide hydrochloride monohydrate, Xagrid (EMEA-000720-PIP01-09) in...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-21T02:00:00Z","last_updated_date":"2010-07-21T02:00:00Z","reference_number":"EMA/282473/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-99-2010-european-medicines-agency-decision-4-june-2010-agreement-paediatric-investigation-plan-granting-waiver-anagrelide-hydrochloride-monohydrate-xagrid-emea-000720-pip01-09_en.pdf"},
    {"id":"34213","name":"P/0306/2013: EMA decision of 5 December 2013 on the acceptance of a modification of an agreed paedia tric investigation plan for asfotase alfa (EMEA-000987-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-17T11:00:00Z","last_updated_date":"2014-01-17T11:00:00Z","reference_number":"EMA/724392/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0306-2013-ema-decision-5-december-2013-acceptance-modification-agreed-paedia-tric-investigation-plan-asfotase-alfa-emea-000987-pip01-10-m01_en.pdf"},
    {"id":"34214","name":"P/113/2012: EMA decision of 29 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ozenoxacin (EMEA-000981-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/332304/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-113-2012-ema-decision-29-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-ozenoxacin-emea-000981-pip01-10-m02_en.pdf"},
    {"id":"34219","name":"P/0158/2013: EMA decision of 5 July 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for glycopyrronium (bromide) (EMEA-001366-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-13T17:30:00Z","last_updated_date":"2013-08-13T17:30:00Z","reference_number":"EMA/332557/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2013-ema-decision-5-july-2013-agreement-paediatric-investigation-plan-granting-waiver-glycopyrronium-bromide-emea-001366-pip01-12_en.pdf"},
    {"id":"34221","name":"P/169/2011: EMA decision of 8 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon alfa-2a\n\n(Pegasys) (EMEA-000298-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/485145/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-169-2011-ema-decision-8-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-peginterferon-alfa-2a-pegasys-emea-000298-pip01-08-m01_en.pdf"},
    {"id":"34239","name":"P/0133/2013: EMA decision of 7 June 2013 on the acceptance of a modification of an agreed paediatric investigation plan for oseltamivir (phosphate) (Tamiflu), (EMEA-000365-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/309066/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0133-2013-ema-decision-7-june-2013-acceptance-modification-agreed-paediatric-investigation-plan-oseltamivir-phosphate-tamiflu-emea-000365-pip01-08-m05_en.pdf"},
    {"id":"34243","name":"P/0365/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for naltrexone\n\n(hydrochloride) / bupropion (hydrochloride) (Mysimba) (EMEA-001373-PIP01-12-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-02T11:48:00Z","last_updated_date":"2018-03-02T11:48:00Z","reference_number":"EMA/762883/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0365-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-naltrexone-hydrochloride-bupropion-hydrochloride-mysimba-emea-001373-pip01-12-m03_en.pdf"},
    {"id":"34253","name":"P/111/2011: EMA decision of 6 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for autologous cartilage derived cultured chondrocytes (EMEA-0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/249498/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-111-2011-ema-decision-6-may-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-autologous-cartilage-derived-cultured-chondrocytes-emea-0_en.pdf"},
    {"id":"34259","name":"P/147/2011: EMA decision of 9 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for chemically modified extract of grass pollen from Holcus la...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/430655/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-147-2011-ema-decision-9-june-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chemically-modified-extract-grass-pollen-holcus-la_en.pdf"},
    {"id":"34291","name":"P/47/2011: EMA decision of 4 March 2011 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen\n\nfractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) /pur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2011-04-05T02:00:00Z","reference_number":"EMA/78783/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-47-2011-ema-decision-4-march-2011-acceptance-modification-agreed-paediatric-investigation-plan-purified-antigen-fractions-inactivated-split-virion-influenza-indonesia-05-2005-h5n1-pur_en.pdf"},
    {"id":"34298","name":"P/0011/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (EMEA-000380-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792644/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-secukinumab-emea-000380-pip01-08-m02_en.pdf"},
    {"id":"34310","name":"P/0092/2012: EMA decision of 29 May 2012 on the granting of a product specific waiver for nifedipine / candesartan (cilexetil), (EMEA-001252-\n\nPIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/273012/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2012-ema-decision-29-may-2012-granting-product-specific-waiver-nifedipine-candesartan-cilexetil-emea-001252-pip01-11_en.pdf"},
    {"id":"34319","name":"P/0287/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron\n\n(Betmiga), (EMEA-000597-PIP02-10-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-23T11:00:00Z","last_updated_date":"2017-01-23T11:00:00Z","reference_number":"EMA/666526/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0287-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-mirabegron-betmiga-emea-000597-pip02-10-m05_en.pdf"},
    {"id":"34326","name":"P/0028/2015: EMA decision of 30 January 2015 on the granting of a product specific waiver for amlodipine / perindopril (erbumine) (EMEA-001669-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/793014/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2015-ema-decision-30-january-2015-granting-product-specific-waiver-amlodipine-perindopril-erbumine-emea-001669-pip01-14_en.pdf"},
    {"id":"34337","name":"P/0124/2016: EMA decision of 15 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP08-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/199536/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2016-ema-decision-15-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-votubia-emea-000019-pip08-12-m02_en.pdf"},
    {"id":"34345","name":"P/0388/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for eluxadoline\n\n(Truberzi) (EMEA-001579-PIP01-13-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T13:05:00Z","last_updated_date":"2018-03-07T13:05:00Z","reference_number":"EMA/801077/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0388-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-eluxadoline-truberzi-emea-001579-pip01-13-m02_en.pdf"},
    {"id":"34361","name":"P/0191/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for agomelatine\n\n(Valdoxan, Thymanax), (EMEA-001181-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:15:00Z","last_updated_date":"2016-09-22T16:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-agomelatine-valdoxan-thymanax-emea-001181-pip01-11-m03_en.pdf"},
    {"id":"34444","name":"P/0247/2016: EMA decision of 13 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab\n\n(Entyvio), (EMEA-000645-PIP01-09-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/513711/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2016-ema-decision-13-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-vedolizumab-entyvio-emea-000645-pip01-09-m04_en.pdf"},
    {"id":"34447","name":"P/0100/2014: EMA decision of 11 April 2014 on the granting of a product-specific waiver for alirocumab (EMEA-001169-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-12T02:00:00Z","last_updated_date":"2014-05-12T02:00:00Z","reference_number":"EMA/169085/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0100-2014-ema-decision-11-april-2014-granting-product-specific-waiver-alirocumab-emea-001169-pip02-13_en.pdf"},
    {"id":"34457","name":"P/286/2011: EMA decision of 30 November 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for alemtuzumab (EMEA-001072-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-12-21T12:15:00Z","last_updated_date":"2011-12-21T12:15:00Z","reference_number":"EMA/910511/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-286-2011-ema-decision-30-november-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-alemtuzumab-emea-001072-pip01-10_en.pdf-0"},
    {"id":"34460","name":"P/0233/2014: EMA decision of 5 September 2014 on the granting of a product specific waiver for antisense oligonucleotide (30-mer) with nucleotide sequence 5”²-GTAATTGCGGCAAGAAGAATTGTTTCTGTC-3”²(CODA001) (EMEA-001628-PIP0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/469204/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2014-ema-decision-5-september-2014-granting-product-specific-waiver-antisense-oligonucleotide-30-mer-nucleotide-sequence-52-gtaattgcggcaagaagaattgtttctgtc-32coda001-emea-001628-pip0_en.pdf"},
    {"id":"34485","name":"P/165/2010: EMA decision of 31 August 2010 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / triphenylacetic acid - 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-07T02:00:00Z","last_updated_date":"2010-10-07T02:00:00Z","reference_number":"EMA/533059/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-165-2010-ema-decision-31-august-2010-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-triphenylacetic-acid-4-1r-2-6-2-26-dichlorobenzyloxyethoxy_en.pdf"},
    {"id":"34501","name":"P/124/2009: European Medicines Agency decision of 19 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for Colesevelam hydrochloride , Cholestagel (EMEA-000543-PIP01-09) in acc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/363648/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-124-2009-european-medicines-agency-decision-19-june-2009-agreement-paediatric-investigation-plan-granting-waiver-colesevelam-hydrochloride-cholestagel-emea-000543-pip01-09-acc_en.pdf"},
    {"id":"34552","name":"P/0127/2017: EMA decision of 5 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ponatinib (Iclusig),\n\n(EMEA-001186-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/224412/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2017-ema-decision-5-may-2017-acceptance-modification-agreed-paediatric-investigation-plan-ponatinib-iclusig-emea-001186-pip01-11-m01_en.pdf"},
    {"id":"34565","name":"P/290/2011: EMA decision of 2 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for N-[4-(3-amino-1Hindazol-\n\n4 yl)phenyl]-N1-(2-fluoro-5-methylphenyl) urea (ABT-869) (EMEA-0003...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/920517/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-290-2011-ema-decision-2-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-n-4-3-amino-1hindazol-4-ylphenyl-n1-2-fluoro-5-methylphenyl-urea-abt-869-emea-0003_en.pdf"},
    {"id":"34577","name":"P/135/2011: EMA decision of 10 June 2011 on the acceptance of a modification of an agreed paediatric investigation plan for benzamide, 4-[4-[[2-\n\n(4-chlorophenyl)-5,5-dimethyl-1-cyclohexen-1-yl]methyl]-1-piperazinyl]-N-[...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/398448/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-135-2011-ema-decision-10-june-2011-acceptance-modification-agreed-paediatric-investigation-plan-benzamide-4-4-2-4-chlorophenyl-55-dimethyl-1-cyclohexen-1-ylmethyl-1-piperazinyl-n_en.pdf"},
    {"id":"34586","name":"P/0180/2013: EMA decision of 30 July 2013 on the granting of a product-specific waiver for amlodipine / ramipril (EMEA-001464-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-03T02:00:00Z","last_updated_date":"2013-09-03T02:00:00Z","reference_number":"EMA/419109/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2013-ema-decision-30-july-2013-granting-product-specific-waiver-amlodipine-ramipril-emea-001464-pip01-13_en.pdf"},
    {"id":"34599","name":"P/222/2010: European Medicines Agency decision of 29 October 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for birch/alder/hazel pollen extract...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-25T01:00:00Z","last_updated_date":"2010-11-25T01:00:00Z","reference_number":"EMA/629246/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-222-2010-european-medicines-agency-decision-29-october-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-birch-alder-hazel-pollen-extract_en.pdf"},
    {"id":"34605","name":"P/0303/2013: EMA decision of 29 November 2013 on the granting of a product specific waiver for metformin hydrochloride / rosuvastatin calcium (EMEA-001508-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/705687/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0303-2013-ema-decision-29-november-2013-granting-product-specific-waiver-metformin-hydrochloride-rosuvastatin-calcium-emea-001508-pip01-13_en.pdf"},
    {"id":"34614","name":"P/0294/2016: EMA decision of 4 November 2016 on the refusal of a modification of an agreed paediatric investigation plan for tolvaptan (Samsca and associated names), (EMEA-001231-PIP02-13-M04)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T11:00:00Z","last_updated_date":"2017-01-20T11:00:00Z","reference_number":"EMA/640003/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2016-ema-decision-4-november-2016-refusal-modification-agreed-paediatric-investigation-plan-tolvaptan-samsca-associated-names-emea-001231-pip02-13-m04_en.pdf"},
    {"id":"34615","name":"P/0222/2016: EMA decision of 12 August 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral for Autologous\n\nCD34+ enriched cell fraction that contains CD34+ cells transduced with len...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-28T02:00:00Z","last_updated_date":"2016-10-28T02:00:00Z","reference_number":"EMA/472121/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2016-ema-decision-12-august-2016-agreement-paediatric-investigation-plan-granting-deferral-autologous-cd34-enriched-cell-fraction-contains-cd34-cells-transduced-len_en.pdf"},
    {"id":"34623","name":"P/0274/2013: EMA decision of 30 October 2013 on the granting of a product specific waiver for ezetimibe / rosuvastatin (EMEA-001478-PIP01-13)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/587702/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0274-2013-ema-decision-30-october-2013-granting-product-specific-waiver-ezetimibe-rosuvastatin-emea-001478-pip01-13_en.pdf"},
    {"id":"34634","name":"P/274/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for adsorbed modified allergen extract of a mixture of 50...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-10T01:00:00Z","last_updated_date":"2011-01-10T01:00:00Z","reference_number":"EMA/683360/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-274-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-adsorbed-modified-allergen-extract-mixture-50_en.pdf"},
    {"id":"34675","name":"P/0328/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-20T01:00:00Z","last_updated_date":"2015-02-20T01:00:00Z","reference_number":"EMA/737895/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0328-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m01_en.pdf"},
    {"id":"34697","name":"P/301/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for rupatadine fumarate\n\n(Rupafin and associated names), (EMEA-000582-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/953992/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-301-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-rupatadine-fumarate-rupafin-associated-names-emea-000582-pip01-09-m01_en.pdf"},
    {"id":"34699","name":"P/0222/2013: EMA decision of 16 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for vorapaxar (EMEA-000778-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-14T01:00:00Z","last_updated_date":"2013-11-14T01:00:00Z","reference_number":"EMA/506135/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2013-ema-decision-16-september-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-vorapaxar-emea-000778-pip02-12_en.pdf"},
    {"id":"34704","name":"P/0205/2013: EMA decision of 3 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for alipogene tiparvovec (Glybera), (EMEA-000292-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/515517/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2013-ema-decision-3-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-alipogene-tiparvovec-glybera-emea-000292-pip01-08-m01_en.pdf"},
    {"id":"34751","name":"P/328/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of rye pollen (EMEA-000957-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769511/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-328-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-rye-pollen-emea-000957_en.pdf"},
    {"id":"34753","name":"P/175/2009: N-Acetyl-L-Cysteine (corresponds to L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to to L-Alanine and L-Glutamine), L-Arginine, Glycine, Glycyl-L-Tyrosine (corresponds to Glycine and L-Tyrosine), ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/551360/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-175-2009-n-acetyl-l-cysteine-corresponds-l-cysteine-l-alanine-l-alanyl-l-glutamine-corresponds-l-alanine-l-glutamine-l-arginine-glycine-glycyl-l-tyrosine-corresponds-glycine-l-tyrosine_en.pdf"},
    {"id":"34755","name":"P/0192/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil fumarate) (Viread) (EMEA-000533-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/530860/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m06_en.pdf"},
    {"id":"34767","name":"P/0070/2013: EMA decision of 26 March 2013 on the granting of a product-specific waiver for hexaminolevulinate (Hexvix), (EMEA-001245-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/114799/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2013-ema-decision-26-march-2013-granting-product-specific-waiver-hexaminolevulinate-hexvix-emea-001245-pip01-11_en.pdf"},
    {"id":"34774","name":"P/0057/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for canakinumab (Ilaris), (EMEA-000060-PIP04-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/153837/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2015-ema-decision-1-april-2015-agreement-paediatric-investigation-plan-granting-waiver-canakinumab-ilaris-emea-000060-pip04-14_en.pdf"},
    {"id":"34808","name":"P/0166/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for apremilast (Otezla), (EMEA-000715-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/507291/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-apremilast-otezla-emea-000715-pip02-11-m02_en.pdf"},
    {"id":"34829","name":"P/0090/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/91878/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2018-ema-decision-16-march-2018-granting-product-specific-waiver-rosuvastatin-ezetimibe-emea-002257-pip01-17_en.pdf"},
    {"id":"34830","name":"P/0167/2012: EMA decision of 26 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for peginterferon lambda-1a (EMEA-001192-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T16:00:00Z","last_updated_date":"2012-08-23T16:00:00Z","reference_number":"EMA/480796/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2012-ema-decision-26-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-peginterferon-lambda-1a-emea-001192-pip01-11_en.pdf"},
    {"id":"34837","name":"P/0285/2012: EMA decision of 23 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for artemether / lumefantrine (Riamet), (EMEA-000777-PIP01-09-M03","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/739152/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0285-2012-ema-decision-23-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-artemether-lumefantrine-riamet-emea-000777-pip01-09-m03_en.pdf"},
    {"id":"34838","name":"P/0319/2013: EMA decision of 19 December 2013 on the granting of a product specific waiver for solifenacin (succinate) / mirabegron (EMEA-001528-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/693823/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0319-2013-ema-decision-19-december-2013-granting-product-specific-waiver-solifenacin-succinate-mirabegron-emea-001528-pip01-13_en.pdf"},
    {"id":"34847","name":"P/64/2010: European Medicines Agency decision on the acceptance of a modification of an agreed paediatric investigation plan for iron, aqua carbonate hydroxy oxo starch sucrose complex (EMEA-000100-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-28T02:00:00Z","last_updated_date":"2010-07-28T02:00:00Z","reference_number":"EMA/273229/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-64-2010-european-medicines-agency-decision-acceptance-modification-agreed-paediatric-investigation-plan-iron-aqua-carbonate-hydroxy-oxo-starch-sucrose-complex-emea-000100-pip01-07-m01_en.pdf"},
    {"id":"34885","name":"Meningococcal group A oligosaccharide Conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM), group C oligosaccharide Conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM), group W-135 oligosacch...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/241589/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/meningococcal-group-oligosaccharide-conjugated-corynebacterium-diphteriae-crm197-protein-mena-crm-group-c-oligosaccharide-conjugated-corynebacterium-diphteriae-crm197-protein-menc-crm-group-w-135_en.pdf"},
    {"id":"34906","name":"P/0074/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for binimetinib (EMEA-\n\n001454-PIP03-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/91844/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-binimetinib-emea-001454-pip03-15-m01_en.pdf"},
    {"id":"34931","name":"P/0269/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for alirocumab\n\n(Praluent), (EMEA-001169-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-25T17:00:00Z","last_updated_date":"2017-10-25T17:00:00Z","reference_number":"EMA/565805/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-alirocumab-praluent-emea-001169-pip01-11-m03_en.pdf"},
    {"id":"34936","name":"P/0109/2015: EMA decision of 1 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant single-chain coagulation factor VIII (EMEA-001215-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/296250/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2015-ema-decision-1-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-single-chain-coagulation-factor-viii-emea-001215-pip01-11-m03_en.pdf"},
    {"id":"34949","name":"P/0205/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin\n\n(Invokana) (EMEA-001030-PIP01-10-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/466842/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-invokana-emea-001030-pip01-10-m07_en.pdf"},
    {"id":"34953","name":"P/139/2009: European Medicines Agency decision of 15 July 2009 on the granting of a product specific waiver for Clostridium collagenase, EMEA-000508-PIP01-08 in accordance with Regulation (EC) No 1901/2006 of the Europea...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-09-16T02:00:00Z","last_updated_date":"2009-09-16T02:00:00Z","reference_number":"EMEA/415970/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-139-2009-european-medicines-agency-decision-15-july-2009-granting-product-specific-waiver-clostridium-collagenase-emea-000508-pip01-08-accordance-regulation-ec-no-1901-2006-europea_en.pdf"},
    {"id":"34959","name":"P/279/2011: EMA decision of 28 November 2011 on the acceptance of a modification of an agreed paediatric investigation plan for lanthanum carbonate hydrate (Fosrenol and associated names), (EMEA-000637-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-12-20T01:00:00Z","last_updated_date":"2011-12-20T01:00:00Z","reference_number":"EMA/878696/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-279-2011-ema-decision-28-november-2011-acceptance-modification-agreed-paediatric-investigation-plan-lanthanum-carbonate-hydrate-fosrenol-associated-names-emea-000637-pip02-10-m01_en.pdf"},
    {"id":"34970","name":"P/0144/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dimethyl fumarate (Tecfidera), (EMEA-000832-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/405166/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0144-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-dimethyl-fumarate-tecfidera-emea-000832-pip01-10-m02_en.pdf"},
    {"id":"34981","name":"P/171/2011: EMA decision of 8 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban,\n\n(Xarelto) (EMEA-000430-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/490576/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-171-2011-ema-decision-8-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m02_en.pdf"},
    {"id":"34987","name":"P/180/2011: EMA decision of 28 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil\n\nfumarate) (Viread), (EMEA-000533-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/430497/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-180-2011-ema-decision-28-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m02_en.pdf"},
    {"id":"34998","name":"P/0136/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for drospirenone (EMEA-001495-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T02:00:00Z","last_updated_date":"2016-07-27T02:00:00Z","reference_number":"EMA/265305/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-drospirenone-emea-001495-pip01-13-m01_en.pdf"},
    {"id":"35001","name":"P/0272/2014: EMA decision of 27 October 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (3S,11aR)-N-[(2,4-Difluorophenyl)methyl]-6-hydroxy-3-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-04T01:00:00Z","last_updated_date":"2014-12-04T01:00:00Z","reference_number":"EMA/624621/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0272-2014-ema-decision-27-october-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-3s11ar-n-24-difluorophenylmethyl-6-hydroxy-3_en.pdf"},
    {"id":"35013","name":"P/0252/2014: EMA decision of 30 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for potassium citrate monohydrated / potassium hydrogen...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/528123/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2014-ema-decision-30-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-potassium-citrate-monohydrated-potassium-hydrogen_en.pdf"},
    {"id":"35022","name":"P/0119/2016: EMA decision of 28 April 2016 on the acceptance of a modification of an agreed paediatric investigation plan for solithromycin (EMEA-001581-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/249385/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2016-ema-decision-28-april-2016-acceptance-modification-agreed-paediatric-investigation-plan-solithromycin-emea-001581-pip01-13-m02_en.pdf"},
    {"id":"35065","name":"P/0245/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for teduglutide, (Revestive) (EMEA-000482-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/627034/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-teduglutide-revestive-emea-000482-pip01-08-m03_en.pdf"},
    {"id":"35083","name":"P/0099/2015: EMA decision of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sofosbuvir/a derivative of (S)-methyl (2-(2-(1H-imidazol-2...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/215118/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0099-2015-ema-decision-8-may-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sofosbuvir-derivative-s-methyl-2-2-1h-imidazol-2_en.pdf"},
    {"id":"35091","name":"P/0236/2013: EMA decision of 24 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for teduglutide (Revestive), (EMEA-000482-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/564670/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2013-ema-decision-24-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-teduglutide-revestive-emea-000482-pip01-08-m01_en.pdf"},
    {"id":"35108","name":"P/214/2009: European Medicines Agency decision of 30 October 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for bromocriptine mesilate (EMEA-000...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/686891/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-214-2009-european-medicines-agency-decision-30-october-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bromocriptine-mesilate-emea-000_en.pdf"},
    {"id":"35124","name":"P/0182/2014: EMA decision of 17 July 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for daclatasvir (EMEA-001485-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/414575/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2014-ema-decision-17-july-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-daclatasvir-emea-001485-pip01-13_en.pdf"},
    {"id":"35143","name":"P/0300/2012: EMA decision of 20 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-07T13:30:00Z","last_updated_date":"2013-02-07T13:30:00Z","reference_number":"EMA/755963/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2012-ema-decision-20-december-2012-acceptance-modification-agreed-paediatric-investigation-plan-ivacaftor-kalydeco-emea-000335-pip01-08-m07_en.pdf"},
    {"id":"35153","name":"P/0125/2013: EMA decision of 28 May 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for lenvatinib (EMEA-001119-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/301820/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2013-ema-decision-28-may-2013-agreement-paediatric-investigation-plan-granting-deferral-lenvatinib-emea-001119-pip02-12_en.pdf"},
    {"id":"35226","name":"P/0133/2015: EMA decision of 12 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (Translarna), (EMEA-000115-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-07T02:00:00Z","last_updated_date":"2015-07-07T02:00:00Z","reference_number":"EMA/368499/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0133-2015-ema-decision-12-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-translarna-emea-000115-pip02-09-m02_en.pdf"},
    {"id":"35227","name":"P/0073/2013: EMA decision of 26 March 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for gabapentin (EMEA-001310-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/113704/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2013-ema-decision-26-march-2013-agreement-paediatric-investigation-plan-granting-waiver-gabapentin-emea-001310-pip01-12_en.pdf"},
    {"id":"35231","name":"P/84/2009: European medicines agency decision of 18 May 2009 on the granting of a product specific waiver for bromfenac sodium sesquihydrate (EMEA-000269-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/289744/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-84-2009-european-medicines-agency-decision-18-may-2009-granting-product-specific-waiver-bromfenac-sodium-sesquihydrate-emea-000269-pip01-08-accordance-regulation-ec-no-1901-2006-e_en.pdf"},
    {"id":"35233","name":"P/0153/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for purified antigen fractions of inactivated split virion influenza A/Indonesia/5/05/ (H5N1) (Puma...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-21T17:00:00Z","last_updated_date":"2012-08-21T17:00:00Z","reference_number":"EMA/478120/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-purified-antigen-fractions-inactivated-split-virion-influenza-indonesia-5-05-h5n1-puma_en.pdf"},
    {"id":"35271","name":"P/0111/2017: EMA decision of 11 April 2017 on the granting of a product specific waiver for prasugrel (hydrochloride) / acetylsalicylic acid (EMEA-\n\n002071-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/176757/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2017-ema-decision-11-april-2017-granting-product-specific-waiver-prasugrel-hydrochloride-acetylsalicylic-acid-emea-002071-pip01-16_en.pdf"},
    {"id":"35280","name":"P/0253/2013: EMA decision of 29 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for plerixafor (Mozobil) (EMEA-000174-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/599869/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0253-2013-ema-decision-29-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-plerixafor-mozobil-emea-000174-pip01-07-m03_en.pdf"},
    {"id":"35288","name":"P/0382/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil (Revatio),\n\n(EMEA-000671-PIP01-09-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/759117/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0382-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-revatio-emea-000671-pip01-09-m09_en.pdf"},
    {"id":"35292","name":"P/0127/2013: EMA decision of 28 May 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for anti-proprotein-convertase-subtilisin/kexin-type-9 human ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/249758/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2013-ema-decision-28-may-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-anti-proprotein-convertase-subtilisin-kexin-type-9-human_en.pdf"},
    {"id":"35303","name":"P/69/2008: European medicines agency decision of 11 August 2008\n\non the application for agreement of a Paediatric Investigation Plan for eplivanserin hemifumarate (EMEA-000114-PIP01-07) in accordance with Regulation (EC)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/416570/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-69-2008-european-medicines-agency-decision-11-august-2008-application-agreement-paediatric-investigation-plan-eplivanserin-hemifumarate-emea-000114-pip01-07-accordance-regulation-ec_en.pdf"},
    {"id":"35322","name":"P/0312/2016: EMA decision of 11 November 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for naldemedine (tosylate) (EMEA-001893-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-10T01:00:00Z","last_updated_date":"2017-01-10T01:00:00Z","reference_number":"EMA/724892/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0312-2016-ema-decision-11-november-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-naldemedine-tosylate-emea-001893-pip01-15_en.pdf"},
    {"id":"35328","name":"P/0265/2017: EMA decision of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for fluticasone (propionate) (EMEA-002140-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/507361/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0265-2017-ema-decision-4-september-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-fluticasone-propionate-emea-002140-pip01-17_en.pdf"},
    {"id":"35334","name":"P/0251/2017: EMA decision of 8 September 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for fenfluramine (hydrochloride) (EMEA-001990-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/503514/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2017-ema-decision-8-september-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-fenfluramine-hydrochloride-emea-001990-pip01-16_en.pdf"},
    {"id":"35377","name":"P/138/2011: EMA decision of 10 June 2011 on the granting of a product specific waiver for canagliflozin / metformin (EMEA-001111-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/356048/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-138-2011-ema-decision-10-june-2011-granting-product-specific-waiver-canagliflozin-metformin-emea-001111-pip01-10_en.pdf"},
    {"id":"35386","name":"P/224/2009: European Medicines Agency Decision of 4 November 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for ambrisentan (Volibris) (EMEA-000...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:09:21Z","last_updated_date":"2009-12-23T00:09:21Z","reference_number":"EMEA/683683/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-224-2009-european-medicines-agency-decision-4-november-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ambrisentan-volibris-emea-000_en.pdf"},
    {"id":"35387","name":"P/265/2011: EMA decision of 28 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy)\n\n(EMEA-000117-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T16:00:00Z","last_updated_date":"2011-11-30T16:00:00Z","reference_number":"EMA/849026/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-265-2011-ema-decision-28-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip02-10-m01_en.pdf"},
    {"id":"35405","name":"P/197/2011: EMA decision of 30 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for golimumab (Simponi)\n\n(EMEA-000265-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/589434/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-197-2011-ema-decision-30-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-golimumab-simponi-emea-000265-pip01-08-m02_en.pdf"},
    {"id":"35420","name":"P/0062/2014: EMA decision of 7 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for oseltamivir (phosphate ) (Tamiflu) (EMEA-000365-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/122026/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0062-2014-ema-decision-7-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-oseltamivir-phosphate-tamiflu-emea-000365-pip01-08-m06_en.pdf"},
    {"id":"35446","name":"P/0111/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol\n\n(hydrochloride) (Palexia and associated names, Yantil and associated names, Tapent...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-24T02:00:00Z","reference_number":"EMA/141780/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tapent_en.pdf"},
    {"id":"35471","name":"P/0044/2016: EMA decision of 26 February 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia and associated names, Yantil and associated names and T...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/133035/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0044-2016-ema-decision-26-february-2016-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-t_en.pdf"},
    {"id":"35499","name":"P/0327/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for loxapine (Adasuve),\n\n(EMEA-001115-PIP01-10-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-02-03T11:35:00Z","last_updated_date":"2017-02-03T11:35:00Z","reference_number":"EMA/756856/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0327-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-loxapine-adasuve-emea-001115-pip01-10-m05_en.pdf"},
    {"id":"35504","name":"P/0046/2012: EMA decision of 29 February 2012 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone dipropionate / formoterol fumarate dihydrate (Foster and associated names, Ka...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/96884/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0046-2012-ema-decision-29-february-2012-acceptance-modification-agreed-paediatric-investigation-plan-beclometasone-dipropionate-formoterol-fumarate-dihydrate-foster-associated-names-ka_en.pdf"},
    {"id":"35516","name":"P/0317/2016: EMA decision of 5 December 2016\n\non the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium) (Zevtera and associated names), (EMEA-000205-PIP02-11-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T09:55:00Z","last_updated_date":"2017-01-30T09:55:00Z","reference_number":"EMA/757936/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0317-2016-ema-decision-5-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-ceftobiprole-medocaril-sodium-zevtera-associated-names-emea-000205-pip02-11-m02_en.pdf"},
    {"id":"35525","name":"P/0148/2012: EMA decision of 24 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of birch...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/471481/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2012-ema-decision-24-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-birch_en.pdf"},
    {"id":"35576","name":"P/0053/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for tasimelteon (Hetlioz), (EMEA-001531-PIP01-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/133054/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0053-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-tasimelteon-hetlioz-emea-001531-pip01-13-m02_en.pdf"},
    {"id":"35588","name":"P/0292/2015: EMA decision of 27 November 2015 on the granting of a product specific waiver for (R)-N-({5-[3-(2,5-Difluorophenyl)-2-(2,3-dihydro-1H-benzimidazol-2-ylidene)-3- oxopropanoyl]-2-fluorophenyl}sulfonyl)-2-hydro...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/509834/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0292-2015-ema-decision-27-november-2015-granting-product-specific-waiver-r-n-5-3-25-difluorophenyl-2-23-dihydro-1h-benzimidazol-2-ylidene-3-oxopropanoyl-2-fluorophenylsulfonyl-2-hydro_en.pdf"},
    {"id":"35598","name":"P/160/2009:  European Medicines Agency decision of 11 August 2009 on the granting of a product specific waiver for testosterone (Intrinsa) (EMEA-000571-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the Eur...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/420697/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-160-2009-european-medicines-agency-decision-11-august-2009-granting-product-specific-waiver-testosterone-intrinsa-emea-000571-pip01-09-accordance-regulation-ec-no-1901-2006-eur_en.pdf"},
    {"id":"35683","name":"P/0099/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for trifarotene\n\n(EMEA-001492-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/202411/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0099-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-trifarotene-emea-001492-pip01-13-m01_en.pdf"},
    {"id":"35699","name":"P/76/2011: EMA decision of 5 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dimethyl fumarate (EMEA-000832-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-10T02:00:00Z","last_updated_date":"2011-05-10T02:00:00Z","reference_number":"EMA/247744/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-76-2011-ema-decision-5-april-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dimethyl-fumarate-emea-000832-pip01-10_en.pdf"},
    {"id":"35708","name":"P/0119/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for human fibrinogen (EMEA-001208-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/284173/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-human-fibrinogen-emea-001208-pip01-11-m02_en.pdf"},
    {"id":"35779","name":"P/0304/2012: EMA decision of 20 December 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for outer membrane vesicles (EMEA-001260-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-11T11:00:00Z","last_updated_date":"2013-02-11T11:00:00Z","reference_number":"EMA/804585/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2012-ema-decision-20-december-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-outer-membrane-vesicles-emea-001260-pip01-11_en.pdf"},
    {"id":"35794","name":"P/190/2009: European Medicines Agency decision of 22 September 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for clopidogrel (Clopidogrel BMS) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/583696/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-190-2009-european-medicines-agency-decision-22-september-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-clopidogrel-clopidogrel-bms_en.pdf"},
    {"id":"35798","name":"P/0065/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for bimatoprost (Lumigan, Latisse), (EMEA-000917-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/85742/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0065-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-bimatoprost-lumigan-latisse-emea-000917-pip01-10-m02_en.pdf"},
    {"id":"35799","name":"P/183/2009: European Medicines Agency decision of 7 September 2009 on the granting of a product specific waiver for ranibizumab (Lucentis), (EMEA-000527-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the Eu...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/516566/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-183-2009-european-medicines-agency-decision-7-september-2009-granting-product-specific-waiver-ranibizumab-lucentis-emea-000527-pip01-08-accordance-regulation-ec-no-1901-2006-eu_en.pdf"},
    {"id":"35821","name":"P/0192/2016: EMA decision of of 15 July 2016 on the acceptance of a modification of an agreed paediatric investigation plan for baricitinib (EMEA-\n\n001220-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T16:16:00Z","last_updated_date":"2016-09-22T16:16:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2016-ema-decision-15-july-2016-acceptance-modification-agreed-paediatric-investigation-plan-baricitinib-emea-001220-pip01-11-m01_en.pdf"},
    {"id":"35835","name":"P/153/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for colistimethate sodium (EMEA-000176-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/513790/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-153-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-colistimethate-sodium-emea-000176-pip01-07-m03_en.pdf"},
    {"id":"35850","name":"P/0163/2017: EMA decision of 30 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for pazopanib (Votrient) (EMEA-000601-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/398038/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2017-ema-decision-30-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-pazopanib-votrient-emea-000601-pip01-09-m04_en.pdf"},
    {"id":"35856","name":"P/0062/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia), (EMEA-000470-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/155875/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0062-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-januvia-emea-000470-pip01-08-m09_en.pdf"},
    {"id":"35857","name":"P/0345/2017: EMA decision of 23 November 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ozanimod (EMEA-\n\n001710-PIP02-14-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/704036/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0345-2017-ema-decision-23-november-2017-acceptance-modification-agreed-paediatric-investigation-plan-ozanimod-emea-001710-pip02-14-m02_en.pdf"},
    {"id":"35907","name":"P/288/2011: EMA decision of 2 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Lasparaginase (EMEA-000013-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/914967/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-288-2011-ema-decision-2-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-lasparaginase-emea-000013-pip01-07-m02_en.pdf"},
    {"id":"35919","name":"P/0091/2014: EMA decision of 4 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (EMEA-000558-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/169122/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0091-2014-ema-decision-4-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-000558-pip01-09-m02_en.pdf"},
    {"id":"35926","name":"P/161/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a product specific waiver for indapamide / amlodipine besilate (EMEA-000896-\n\nPIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/477270/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-161-2010-ema-decision-27-august-2010-agreement-paediatric-investigation-plan-granting-product-specific-waiver-indapamide-amlodipine-besilate-emea-000896-pip01-10_en.pdf"},
    {"id":"35933","name":"P/201/2009: European Medicines Agency decision of 9 October 2009 on the granting of a product specific waiver for ibuprofen / famotidine (EMEA-000616-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the Europ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-07T00:09:21Z","last_updated_date":"2009-12-07T00:09:21Z","reference_number":"EMEA/617482/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-201-2009-european-medicines-agency-decision-9-october-2009-granting-product-specific-waiver-ibuprofen-famotidine-emea-000616-pip01-09-accordance-regulation-ec-no-1901-2006-europ_en.pdf"},
    {"id":"35943","name":"P/0082/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for durvalumab (EMEA-002028-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/88167/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0082-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-durvalumab-emea-002028-pip01-16_en.pdf"},
    {"id":"35960","name":"P/0111/2016: EMA decision of 15 April 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for human normal immunoglobulin (EMEA-001853-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/203693/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2016-ema-decision-15-april-2016-agreement-paediatric-investigation-plan-granting-waiver-human-normal-immunoglobulin-emea-001853-pip01-15_en.pdf"},
    {"id":"35999","name":"P/27/2010: European medicines agency decision of of 5 March 2010 on the acceptance of a modification of an agreed Paediatric Investigation Plan for pramipexole dihydrochloride (monohydrate) (Sifrol) (EMEA-000041-PIP01-07...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-04-19T02:00:00Z","last_updated_date":"2010-04-19T02:00:00Z","reference_number":"EMEA/466817/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-27-2010-european-medicines-agency-decision-5-march-2010-acceptance-modification-agreed-paediatric-investigation-plan-pramipexole-dihydrochloride-monohydrate-sifrol-emea-000041-pip01-07_en.pdf"},
    {"id":"36007","name":"P/0261/2012: EMA decision of 19 November 2012 on the granting of a product-specific waiver for N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-\n\nylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochlori...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"EMA/679908/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0261-2012-ema-decision-19-november-2012-granting-product-specific-waiver-n-tert-butyl-3-5-methyl-2-4-2-pyrrolidin-1-ylethoxyphenylaminopyrimidin-4-ylaminobenzenesulfonamide-dihydrochlori_en.pdf"},
    {"id":"36013","name":"P/0014/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/10894/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0014-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised_en.pdf"},
    {"id":"36020","name":"P/0295/2013: EMA decision of 29 November 2013 on the acceptance of a modification of an agreed paediatric investigation plan for certolizumab pegol (Cimzia) (EMEA-001071-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/708155/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2013-ema-decision-29-november-2013-acceptance-modification-agreed-paediatric-investigation-plan-certolizumab-pegol-cimzia-emea-001071-pip02-12-m01_en.pdf"},
    {"id":"36022","name":"P/82/2010: European Medicines Agency decision of of 30 April 2010\n\non the granting of a product specific waiver for vorinostat (EMEA-000805-PIP01-09) in accordance with\n\nRegulation (EC) No 1901/2006 of the European Parli...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/262857/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-82-2010-european-medicines-agency-decision-30-april-2010-granting-product-specific-waiver-vorinostat-emea-000805-pip01-09-accordance-regulation-ec-no-1901-2006-european-parli_en.pdf"},
    {"id":"36043","name":"P/0173/2016: EMA decision of 17 June 2016 on the granting of a product specific waiver for ciclosporin (EMEA-001916-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/385704/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2016-ema-decision-17-june-2016-granting-product-specific-waiver-ciclosporin-emea-001916-pip01-15_en.pdf"},
    {"id":"36090","name":"P/0297/2016: EMA decision of 4 November 2016\n\non the acceptance of a modification of an agreed paediatric investigation plan for autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the h...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:17:00Z","last_updated_date":"2017-01-20T16:17:00Z","reference_number":"EMA/669484/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0297-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-encoding-h_en.pdf"},
    {"id":"36105","name":"P/0256/2012: EMA decision of 26 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aripiprazole (Abilify), (EMEA-000235-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/646932/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2012-ema-decision-26-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-aripiprazole-abilify-emea-000235-pip02-10-m02_en.pdf-0"},
    {"id":"36110","name":"P/0307/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for odanacatib (EMEA-001123-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/761887/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-odanacatib-emea-001123-pip01-11-m03_en.pdf"},
    {"id":"36136","name":"P/0073/2012: EMA decision of 24 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for coagulation factor IX (recombinant) (EMEA-000661-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/250284/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2012-ema-decision-24-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-coagulation-factor-ix-recombinant-emea-000661-pip01-09-m05_en.pdf"},
    {"id":"36152","name":"P/0104/2014: EMA decision of 2 May 2014 on the granting of a product specific waiver for anastrozole / levonorgestrel (EMEA-001575-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-06T02:00:00Z","last_updated_date":"2014-06-06T02:00:00Z","reference_number":"EMA/232071/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0104-2014-ema-decision-2-may-2014-granting-product-specific-waiver-anastrozole-levonorgestrel-emea-001575-pip01-13_en.pdf"},
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    {"id":"36223","name":"P/0247/2014: EMA decision of 30 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for secukinumab (EMEA-000380-PIP02-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/509571/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2014-ema-decision-30-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-secukinumab-emea-000380-pip02-09-m02_en.pdf"},
    {"id":"36230","name":"P/0079/2013: EMA decision of 27 March 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for vancomycin (EMEA-001311-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-04T02:00:00Z","last_updated_date":"2013-10-04T02:00:00Z","reference_number":"EMA/113893/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2013-ema-decision-27-march-2013-agreement-paediatric-investigation-plan-granting-waiver-vancomycin-emea-001311-pip01-12_en.pdf"},
    {"id":"36233","name":"P/0299/2017: EMA decision of 4 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for liposomal\n\ncombination of cytarabine and daunorubicin (EMEA-001858-PIP02-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/635150/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2017-ema-decision-4-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-liposomal-combination-cytarabine-daunorubicin-emea-001858-pip02-16-m01_en.pdf"},
    {"id":"36239","name":"P/0016/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for bosutinib (EMEA-000727-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-03-29T02:00:00Z","last_updated_date":"2016-03-29T02:00:00Z","reference_number":"EMA/3693/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-bosutinib-emea-000727-pip01-09-m01_en.pdf"},
    {"id":"36252","name":"P/0096/2012: EMA decision of 30 May 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarb...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-25T18:00:00Z","last_updated_date":"2012-06-25T18:00:00Z","reference_number":"EMA/273210/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0096-2012-ema-decision-30-may-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-trisodium-3-1s3r-1-biphenyl-4-ylmethyl-3-ethoxycarb_en.pdf"},
    {"id":"36253","name":"P/0130/2014: EMA decision of 10 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for peginterferon alfa-2a (Pegasys), (EMEA-000298-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/319524/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2014-ema-decision-10-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-peginterferon-alfa-2a-pegasys-emea-000298-pip01-08-m04_en.pdf"},
    {"id":"36264","name":"P/0010/2012: EMA decision of 24 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for elvitegravir\n\n(EMEA-000968-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/7469/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2012-ema-decision-24-january-2012-agreement-paediatric-investigation-plan-granting-deferral-elvitegravir-emea-000968-pip02-11_en.pdf"},
    {"id":"36267","name":"P/0177/2014: EMA decision of 7 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tobramycin (Tobi Podhaler), (EMEA-000184-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/391612/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2014-ema-decision-7-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-tobramycin-tobi-podhaler-emea-000184-pip01-08-m02_en.pdf"},
    {"id":"36277","name":"P/0270/2012: EMA decision of 20 November 2012 on the granting of a product-specific waiver for amlodipine (besylate) / valsartan (EMEA-001343-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/646965/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0270-2012-ema-decision-20-november-2012-granting-product-specific-waiver-amlodipine-besylate-valsartan-emea-001343-pip01-12_en.pdf"},
    {"id":"36291","name":"P/0195/2016: EMA decision of 15 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for indacaterol (acetate) / glycopyrronium (bromide) / momet...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/399748/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2016-ema-decision-15-july-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-indacaterol-acetate-glycopyrronium-bromide-momet_en.pdf"},
    {"id":"36299","name":"P/0132/2018: EMA decision of 11 April 2018 on the acceptance of a modification of an agreed paediatric investigation plan for testosterone (EMEA-001529-PIP02-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-24T02:00:00Z","last_updated_date":"2018-07-25T15:20:00Z","reference_number":"EMA/221403/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0132-2018-ema-decision-11-april-2018-acceptance-modification-agreed-paediatric-investigation-plan-testosterone-emea-001529-pip02-14-m01_en.pdf"},
    {"id":"36305","name":"P/0250/2017: EMA decision of 8 September 2017 on the granting of a product specific waiver for human normal immunoglobulin (EMEA-002084-PIP01-\n\n16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/526256/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2017-ema-decision-8-september-2017-granting-product-specific-waiver-human-normal-immunoglobulin-emea-002084-pip01-16_en.pdf"},
    {"id":"36311","name":"P/0239/2017: EMA decision of 11 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab\n\n(Nucala), (EMEA-000069-PIP02-10-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-29T02:00:00Z","last_updated_date":"2017-09-29T02:00:00Z","reference_number":"EMA/491414/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2017-ema-decision-11-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-nucala-emea-000069-pip02-10-m08_en.pdf"},
    {"id":"36314","name":"P/140/2010: European Medicines Agency decision of 30 July 2010 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation factor VIII/von Willebrand factor (EMEA-000312-PIP01-08-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/465096/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-140-2010-european-medicines-agency-decision-30-july-2010-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-emea-000312-pip01-08_en.pdf"},
    {"id":"36318","name":"P/242/2011: EMA decision of 30 September 2011 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine\n\n(hydrochloride) (EMEA-000317-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-17T02:00:00Z","last_updated_date":"2011-10-17T02:00:00Z","reference_number":"EMA/764020/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-242-2011-ema-decision-30-september-2011-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-emea-000317-pip01-08-m02_en.pdf"},
    {"id":"36330","name":"P/0250/2012: EMA decision of 24 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tazarotene (EMEA-000510-PIP02-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/666117/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2012-ema-decision-24-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-tazarotene-emea-000510-pip02-10-m02_en.pdf"},
    {"id":"36364","name":"P/308/2013: EMA decision of 19 December 2013 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (Remodulin and associated names) (EMEA-000207-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-04T01:00:00Z","last_updated_date":"2014-02-04T01:00:00Z","reference_number":"EMA/693864/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-308-2013-ema-decision-19-december-2013-acceptance-modification-agreed-paediatric-investigation-plan-treprostinil-remodulin-associated-names-emea-000207-pip01-08-m04_en.pdf"},
    {"id":"36378","name":"P/0263/2016: EMA decision of 5 October 2016 on the granting of a product specific waiver for lifitegrast (EMEA-001979-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/593398/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0263-2016-ema-decision-5-october-2016-granting-product-specific-waiver-lifitegrast-emea-001979-pip01-16_en.pdf"},
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    {"id":"36403","name":"P/109/2012: EMA decision of 8 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil fumarate) Viread (EMEA-000533-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/358603/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-109-2012-ema-decision-8-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m03_en.pdf"},
    {"id":"36420","name":"P/0013/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/10910/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised_en.pdf"},
    {"id":"36426","name":"P/0141/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole\n\n(Noxafil) (EMEA-000468-PIP02-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/382958/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m02_en.pdf"},
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    {"id":"36454","name":"P/0185/2013: EMA decision of 30 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tocilizumab\n\n(RoActemra), (EMEA-000309-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/449115/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2013-ema-decision-30-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-tocilizumab-roactemra-emea-000309-pip01-08-m05_en.pdf"},
    {"id":"36459","name":"P/0008/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for idursulfase (EMEA-\n\n000294-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/34943/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-idursulfase-emea-000294-pip02-12-m01_en.pdf"},
    {"id":"36460","name":"P/0060/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for rituximab (MabThera) (EMEA-000308-PIP02-11-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/138312/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0060-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-rituximab-mabthera-emea-000308-pip02-11-m01_en.pdf"},
    {"id":"36462","name":"P/0028/2013: EMA decision of 26 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for poly(oxy-1,2-ethanediyl),alpha-hydro-omega-methoxy-133 ester with granulocyte colony-stimul...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/23724/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2013-ema-decision-26-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-polyoxy-12-ethanediylalpha-hydro-omega-methoxy-133-ester-granulocyte-colony-stimul_en.pdf"},
    {"id":"36465","name":"P/0300/2017: EMA decision of 4 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab\n\n(EMEA-001523-PIP02-14-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-02-16T01:00:00Z","last_updated_date":"2018-02-16T01:00:00Z","reference_number":"EMA/637572/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2017-ema-decision-4-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-guselkumab-emea-001523-pip02-14-m01_en.pdf"},
    {"id":"36472","name":"P/0268/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto) (EMEA-000430-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/766392/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m08_en.pdf"},
    {"id":"36479","name":"P/0015/2013: EMA decision of 25 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for laquinimod (sodium) (EMEA-000972-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/37454/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0015-2013-ema-decision-25-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-laquinimod-sodium-emea-000972-pip01-10-m02_en.pdf"},
    {"id":"36484","name":"P/0215/2017: EMA decision of 9 August 2017 on the granting of a product-specific waiver for macitentan (Opsumit), (EMEA-001032-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-09-28T02:00:00Z","last_updated_date":"2017-09-28T02:00:00Z","reference_number":"EMA/459094/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2017-ema-decision-9-august-2017-granting-product-specific-waiver-macitentan-opsumit-emea-001032-pip02-17_en.pdf"},
    {"id":"36492","name":"P/107/2011: EMA decision of 6 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for human coagulation Factor VIII / von Willebrand Factor, (EMEA-000312-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/281206/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-107-2011-ema-decision-6-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-human-coagulation-factor-viii-von-willebrand-factor-emea-000312-pip01-08-m02_en.pdf"},
    {"id":"36508","name":"P/0048/2018: EMA decision of 22 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat)\n\n(EMEA-000402-PIP03-17-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T15:28:00Z","last_updated_date":"2018-04-17T15:28:00Z","reference_number":"EMA/83693/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0048-2018-ema-decision-22-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-lacosamide-vimpat-emea-000402-pip03-17-m02_en.pdf"},
    {"id":"36522","name":"P/0074/2014: EMA decision of 2 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (Zinforo) (EMEA-000769-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/103256/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2014-ema-decision-2-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-zinforo-emea-000769-pip01-09-m04_en.pdf"},
    {"id":"36534","name":"P/0246/2014: EMA decision of 29 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for nanobody directed towards the fusion protein of human respiratory syncytial virus (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/508734/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2014-ema-decision-29-september-2014-agreement-paediatric-investigation-plan-granting-deferral-nanobody-directed-towards-fusion-protein-human-respiratory-syncytial-virus_en.pdf"},
    {"id":"36536","name":"P/104/2012: EMA decision of 1 June 2012 on the granting of a product specific waiver for masitinib (mesylate), (EMEA-001266-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-19T17:00:00Z","last_updated_date":"2012-07-19T17:00:00Z","reference_number":"EMA/331927/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-104-2012-ema-decision-1-june-2012-granting-product-specific-waiver-masitinib-mesylate-emea-001266-pip01-12_en.pdf"},
    {"id":"36539","name":"P/0169/2013: EMA decision of 30 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (EMEA-000576-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/419497/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2013-ema-decision-30-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-emea-000576-pip01-09-m03_en.pdf"},
    {"id":"36549","name":"P/112/2009: European Medicines Agency decision of 15 June 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for dexamethasone/ciprofloxacin hydrochloride (EMEA-000444-PIP01-08) in a...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/347310/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-112-2009-european-medicines-agency-decision-15-june-2009-agreement-paediatric-investigation-plan-granting-waiver-dexamethasone-ciprofloxacin-hydrochloride-emea-000444-pip01-08_en.pdf"},
    {"id":"36563","name":"P/0025/2014: EMA decision of 24 January 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for cobimetinib (EMEA-001425-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/738900/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0025-2014-ema-decision-24-january-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-cobimetinib-emea-001425-pip01-13_en.pdf"},
    {"id":"36569","name":"P/0316/2014: EMA decision of 5 December 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human immunoglobulin G2Lambda monoclonal antibody dir...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/739905/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0316-2014-ema-decision-5-december-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-immunoglobulin-g2lambda-monoclonal-antibody-dir_en.pdf"},
    {"id":"36573","name":"P/98/2010: European Medicines Agency decision of 4 June 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral  for fidaxomicin (EMEA-000636-PIP01-09) in accordance with Regulation (EC...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/335570/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-98-2010-european-medicines-agency-decision-4-june-2010-agreement-paediatric-investigation-plan-granting-deferral-fidaxomicin-emea-000636-pip01-09-accordance-regulation-ec_en.pdf"},
    {"id":"36593","name":"P/0119/2014: EMA decision of 7 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (EMEA-001030-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-12T16:00:00Z","last_updated_date":"2014-06-12T16:00:00Z","reference_number":"EMA/182181/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2014-ema-decision-7-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-canagliflozin-emea-001030-pip01-10-m02_en.pdf"},
    {"id":"36599","name":"P/59/2011: EMA decision of 21 February 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for chimeric monoclonal antibody against human CD30 coval...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2011-03-08T01:00:00Z","reference_number":"EMA/126246/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-59-2011-ema-decision-21-february-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-chimeric-monoclonal-antibody-against-human-cd30-coval_en.pdf"},
    {"id":"36614","name":"P/0159/2016: EMA decision of 15 June 2016 on the refusal of a modification of an agreed paediatric investigation plan for tafluprost (Taflotan and\n\nassociated names) (EMEA-001187-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/380528/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2016-ema-decision-15-june-2016-refusal-modification-agreed-paediatric-investigation-plan-tafluprost-taflotan-associated-names-emea-001187-pip01-11-m03_en.pdf"},
    {"id":"36629","name":"P/0234/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for decitabine\n\n(Dacogen), (EMEA-000555-PIP01-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/434829/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-decitabine-dacogen-emea-000555-pip01-09-m06_en.pdf"},
    {"id":"36635","name":"P/0312/2012: European medicines agency decision of 21 December 2012\n\non the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia), (EMEA-000470-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-07T13:30:00Z","last_updated_date":"2013-02-07T13:30:00Z","reference_number":"EMA/816339/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0312-2012-european-medicines-agency-decision-21-december-2012-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-januvia-emea-000470-pip01-08-m06_en.pdf"},
    {"id":"36645","name":"P/156/2010: EMA decision of 27 August 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for ivabradine hydrochloride (Corlentor) (EMEA-000627-PIP01-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-06T02:00:00Z","last_updated_date":"2010-10-06T02:00:00Z","reference_number":"EMA/477307/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-156-2010-ema-decision-27-august-2010-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-ivabradine-hydrochloride-corlentor-emea-000627-pip01_en.pdf"},
    {"id":"36677","name":"P/0129/2012: EMA decision of 4 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ulimorelin (EMEA-001144-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-09T14:00:00Z","last_updated_date":"2012-08-09T14:00:00Z","reference_number":"EMA/414917/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2012-ema-decision-4-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ulimorelin-emea-001144-pip01-11_en.pdf"},
    {"id":"36678","name":"P/0335/2017: EMA decision of 31 October 2017 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-002202-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/666332/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0335-2017-ema-decision-31-october-2017-granting-product-specific-waiver-rosuvastatin-ezetimibe-emea-002202-pip01-17_en.pdf"},
    {"id":"36684","name":"P/120/2010: European Medicines Agency decision of 9 July 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for human normal immunoglobulin (EMEA-000775-PIP01-09) in accordance with ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/413296/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-120-2010-european-medicines-agency-decision-9-july-2010-agreement-paediatric-investigation-plan-granting-waiver-human-normal-immunoglobulin-emea-000775-pip01-09-accordance_en.pdf"},
    {"id":"36697","name":"P/236/2010: EMA decision of of 26 November 2010 on the acceptance of a modification of an agreed paediatric investigation plan for etanercept (Enbrel)\n\n(EMEA-000299-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-20T01:00:00Z","last_updated_date":"2010-12-20T01:00:00Z","reference_number":"EMA/706484/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-236-2010-ema-decision-26-november-2010-acceptance-modification-agreed-paediatric-investigation-plan-etanercept-enbrel-emea-000299-pip01-08-m02_en.pdf"},
    {"id":"36702","name":"P/191/2011: EMA decision of 3 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (EMEA-000335-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/591808/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-191-2011-ema-decision-3-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-n-24-di-tert-butyl-5-hydroxyphenyl-14-dihydro-4-oxoquinoline-3-carboxamide-emea-000335-pip_en.pdf"},
    {"id":"36714","name":"P/0109/2014: EMA decision of 5 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for eribulin (Halaven), (EMEA-001261-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-12T16:00:00Z","last_updated_date":"2015-06-02T13:00:00Z","reference_number":"EMA/231361/2014 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2014-ema-decision-5-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-eribulin-halaven-emea-001261-pip01-11-m01_en.pdf"},
    {"id":"36721","name":"P/0145/2012: EMA decision of 23 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lurasidone (hydrochloride), (EMEA-001230-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T17:15:00Z","last_updated_date":"2012-10-08T11:50:00Z","reference_number":"EMA/458276/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2012-ema-decision-23-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lurasidone-hydrochloride-emea-001230-pip01-11_en.pdf"},
    {"id":"36726","name":"P/82/2008: European medicines agency decision of of 01 October 2008\n\non the application for agreement of a Paediatric Investigation Plan for Bevacizumab, (Avastin) EMEA-000056-PIP01-07 in accordance with Regulation (EC) ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-11-24T00:00:00Z","last_updated_date":"2008-11-24T00:00:00Z","reference_number":"EMEA/409573/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-82-2008-european-medicines-agency-decision-01-october-2008-application-agreement-paediatric-investigation-plan-bevacizumab-avastin-emea-000056-pip01-07-accordance-regulation-ec_en.pdf"},
    {"id":"36727","name":"P/0017/2012: EMA decision of 25 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for methyl aminolevulinate (hydrochloride), (EMEA-000698...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/994146/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2012-ema-decision-25-january-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-methyl-aminolevulinate-hydrochloride-emea-000698_en.pdf"},
    {"id":"36756","name":"P/0194/2013: EMA decision of 8 August 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for idursulfase (EMEA-000294-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/508748/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0194-2013-ema-decision-8-august-2013-agreement-paediatric-investigation-plan-granting-waiver-idursulfase-emea-000294-pip02-12_en.pdf"},
    {"id":"36761","name":"P/0229/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir /\n\nabacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/434830/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-dolutegravir-abacavir-lamivudine-triumeq-emea-001219-pip01-11-m03_en.pdf"},
    {"id":"36768","name":"P/0376/2017: EMA decision of 1 December 2017 on the granting of a product specific waiver for resminostat (EMEA-002211-PIP01-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T14:03:00Z","last_updated_date":"2018-03-07T14:03:00Z","reference_number":"EMA/711131/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0376-2017-ema-decision-1-december-2017-granting-product-specific-waiver-resminostat-emea-002211-pip01-17_en.pdf"},
    {"id":"36783","name":"P/0311/2016: EMA decision of 7 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for daclatasvir\n\n(Daklinza), (EMEA-001191-PIP01-11-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T11:00:00Z","last_updated_date":"2017-01-20T11:00:00Z","reference_number":"EMA/721473/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0311-2016-ema-decision-7-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-daclatasvir-daklinza-emea-001191-pip01-11-m02_en.pdf"},
    {"id":"36788","name":"P/0374/2017: EMA decision of 1 December 2017 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-03-07T14:03:00Z","last_updated_date":"2018-03-07T14:03:00Z","reference_number":"EMA/763167/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0374-2017-ema-decision-1-december-2017-granting-product-specific-waiver-atorvastatin-ezetimibe-emea-002207-pip01-17_en.pdf"},
    {"id":"36827","name":"P/55/2008: European medicines agency decision of 20 July 2008 on the application for product specific waiver for Epoetin theta (EMEA-000217-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parlia...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-08T02:00:00Z","last_updated_date":"2008-09-08T02:00:00Z","reference_number":"EMEA/357428/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-55-2008-european-medicines-agency-decision-20-july-2008-application-product-specific-waiver-epoetin-theta-emea-000217-pip01-08-accordance-regulation-ec-no-1901-2006-european-parlia_en.pdf"},
    {"id":"36847","name":"P/0322/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for saxagliptin / dapagliflozin (EMEA-001677-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/759423/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0322-2014-ema-decision-19-december-2014-granting-product-specific-waiver-saxagliptin-dapagliflozin-emea-001677-pip01-14_en.pdf"},
    {"id":"36860","name":"P/0304/2013: EMA decision of 29 November 2013 on the granting of a product specific waiver for synthetic double-stranded siRNA oligonucleotide\n\ndirected against transthyretin mRNA (EMEA-001520-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-01-06T01:00:00Z","last_updated_date":"2014-01-06T01:00:00Z","reference_number":"EMA/647572/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2013-ema-decision-29-november-2013-granting-product-specific-waiver-synthetic-double-stranded-sirna-oligonucleotide-directed-against-transthyretin-mrna-emea-001520-pip01-13_en.pdf"},
    {"id":"36929","name":"P/4/2007: European medicines agency decision of 11 December 2007 on the application for a product specific waiver for Blopress Comp and associated names, Candesartan/Hydrochlorothiazide (EMEA-000040-PIP01-07) in accordan...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2007-12-20T00:00:00Z","last_updated_date":"2007-12-20T00:00:00Z","reference_number":"EMEA/575788/2007","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-4-2007-european-medicines-agency-decision-11-december-2007-application-product-specific-waiver-blopress-comp-associated-names-candesartan-hydrochlorothiazide-emea-000040-pip01-07-accordan_en.pdf"},
    {"id":"36941","name":"P/0078/2015: EMA decision of 1 April 2015 on the granting of a product-specific waiver for ibuprofen/codeine (EMEA-001713-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/161012/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2015-ema-decision-1-april-2015-granting-product-specific-waiver-ibuprofen-codeine-emea-001713-pip02-14_en.pdf"},
    {"id":"36987","name":"P/0151/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for isavuconazonium (sulfate), (Cresemba) (EMEA-001301-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/293458/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-isavuconazonium-sulfate-cresemba-emea-001301-pip02-12-m01_en.pdf"},
    {"id":"36991","name":"P/0270/2015: EMA decision of 3 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for EMEA-000673-PIP01-09-M08","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/690926/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0270-2015-ema-decision-3-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-emea-000673-pip01-09-m08_en.pdf"},
    {"id":"37012","name":"P/185/2009: european medicines agency decision of 7 September 2009\n\non the granting of a product specific waiver for tramadol / paracetamol\n\n(EMEA-000598-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/548803/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-185-2009-european-medicines-agency-decision-7-september-2009-granting-product-specific-waiver-tramadol-paracetamol-emea-000598-pip01-09-accordance-regulation-ec-no-1901-2006-e_en.pdf"},
    {"id":"37015","name":"P/0081/2015: EMA decision of 10 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pixantrone (dimaleate) (Pixuvri), (EMEA-000713-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/212181/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2015-ema-decision-10-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-pixantrone-dimaleate-pixuvri-emea-000713-pip02-10-m03_en.pdf"},
    {"id":"37026","name":"P/115/2010: European Medicines Agency decision of 7 July 2010\n\non the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for trifluoromethyl-benzyloxyimino-ethy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-29T02:00:00Z","last_updated_date":"2010-07-29T02:00:00Z","reference_number":"EMA/413185/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-115-2010-european-medicines-agency-decision-7-july-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-trifluoromethyl-benzyloxyimino-ethy_en.pdf"},
    {"id":"37041","name":"P/0321/2016: EMA decision of 2 December 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sunitinib (Sutent),\n\n(EMEA-000342-PIP01-08-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-30T11:23:00Z","last_updated_date":"2017-01-30T11:23:00Z","reference_number":"EMA/765279/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0321-2016-ema-decision-2-december-2016-acceptance-modification-agreed-paediatric-investigation-plan-sunitinib-sutent-emea-000342-pip01-08-m05_en.pdf"},
    {"id":"37050","name":"P/181/2010: European Medicines Agency decision of 24 September 2010 on the granting of a product specific waiver for pasireotide (EMEA-000464-PIP02-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/540808/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-181-2010-european-medicines-agency-decision-24-september-2010-granting-product-specific-waiver-pasireotide-emea-000464-pip02-10_en.pdf"},
    {"id":"37055","name":"P/0052/2013: EMA decision of 1 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for asfotase alfa (EMEA-000987-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/113104/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0052-2013-ema-decision-1-march-2013-agreement-paediatric-investigation-plan-granting-deferral-asfotase-alfa-emea-000987-pip01-10_en.pdf"},
    {"id":"37061","name":"P/124/2011: EMA decision of 7 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for cobicistat (EMEA-000969-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/360007/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-124-2011-ema-decision-7-june-2011-agreement-paediatric-investigation-plan-granting-deferral-cobicistat-emea-000969-pip01-10_en.pdf"},
    {"id":"37084","name":"P/0249/2013: EMA decision of 18 October 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for tedizolid (phosphate) (EMEA-001379-PIP01-12)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/585513/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0249-2013-ema-decision-18-october-2013-agreement-paediatric-investigation-plan-granting-deferral-tedizolid-phosphate-emea-001379-pip01-12_en.pdf"},
    {"id":"37099","name":"P/4/2008: European medicines agency decision of 1 February 2008 on the application for product specific waiver for Glycopyrronium bromide EMEA-000058-PIP01-07 in accordance with Regulation (EC) No 1901/2006 of the Europe...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-01-15T01:00:00Z","last_updated_date":"2008-01-15T01:00:00Z","reference_number":"EMEA/43454/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-4-2008-european-medicines-agency-decision-1-february-2008-application-product-specific-waiver-glycopyrronium-bromide-emea-000058-pip01-07-accordance-regulation-ec-no-1901-2006-europe_en.pdf"},
    {"id":"37109","name":"P/189/2011: EMA decision of 2 August 2011 on the granting of a product specific waiver for teriparatide (Forsteo), (EMEA-001135-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-13T02:00:00Z","last_updated_date":"2011-09-13T02:00:00Z","reference_number":"EMA/507484/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-189-2011-ema-decision-2-august-2011-granting-product-specific-waiver-teriparatide-forsteo-emea-001135-pip01-11_en.pdf"},
    {"id":"37120","name":"P/0066/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir (EMEA-000968-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/103410/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-emea-000968-pip02-11-m01_en.pdf"},
    {"id":"37123","name":"P/0340/2014: EMA decision of 22 December 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for Clostridium difficile toxin B human monoclonal antibody (EMEA-001645-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/711355/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0340-2014-ema-decision-22-december-2014-agreement-paediatric-investigation-plan-granting-deferral-clostridium-difficile-toxin-b-human-monoclonal-antibody-emea-001645-pip01-14_en.pdf"},
    {"id":"37127","name":"P/0116/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for rovalpituzumab tesirine (EMEA-002292-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T02:00:00Z","last_updated_date":"2018-07-25T02:00:00Z","reference_number":"EMA/197915/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0116-2018-ema-decision-11-april-2018-granting-product-specific-waiver-rovalpituzumab-tesirine-emea-002292-pip01-17_en.pdf"},
    {"id":"37140","name":"P/0266/2013: EMA decision of 30 October 2013 on the agreement of a paediatric investigation plan for autologous CD34+ cells transduced with lentiviral vector containing the human Wiskott Aldrich Syndrom Protein gene (EME...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/586558/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2013-ema-decision-30-october-2013-agreement-paediatric-investigation-plan-autologous-cd34-cells-transduced-lentiviral-vector-containing-human-wiskott-aldrich-syndrom-protein-gene-eme_en.pdf"},
    {"id":"37162","name":"P/0115/2017: EMA decision of 21 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine\n\n(EMEA-001676-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/247011/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0115-2017-ema-decision-21-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-doravirine-emea-001676-pip01-14-m01_en.pdf"},
    {"id":"37164","name":"P/259/2010: EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for betula alba allergen extract (EMEA-000919-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/670696/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-259-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-betula-alba-allergen-extract-emea-000919-pip01-10_en.pdf"},
    {"id":"37187","name":"P/0117/2015: EMA decision of 5 June 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mirabegron (Betmiga), (EMEA-000597-PIP03-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T02:00:00Z","last_updated_date":"2015-07-03T02:00:00Z","reference_number":"EMA/297824/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0117-2015-ema-decision-5-june-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mirabegron-betmiga-emea-000597-pip03-15_en.pdf"},
    {"id":"37194","name":"P/0137/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for selumetinib (EMEA-001585-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-07-27T02:00:00Z","last_updated_date":"2016-07-27T02:00:00Z","reference_number":"EMA/249389/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-selumetinib-emea-001585-pip01-13-m01_en.pdf"},
    {"id":"37196","name":"P/0171/2017: EMA decision of 3 July 2017 on the acceptance of a modification of an agreed paediatric investigation plan for methoxyflurane (Penthrox), (EMEA-000334-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/357762/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2017-ema-decision-3-july-2017-acceptance-modification-agreed-paediatric-investigation-plan-methoxyflurane-penthrox-emea-000334-pip01-08-m06_en.pdf"},
    {"id":"37244","name":"P/0250/2013: EMA decision of 21 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for human heterologous liver cells (EMEA-000067-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/496850/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2013-ema-decision-21-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-human-heterologous-liver-cells-emea-000067-pip02-11-m01_en.pdf"},
    {"id":"37255","name":"P/0033/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (Januvia),\n\n(EMEA-000470-PIP01-08-M10)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T11:41:00Z","last_updated_date":"2018-04-18T11:41:00Z","reference_number":"EMA/848760/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0033-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-januvia-emea-000470-pip01-08-m10_en.pdf"},
    {"id":"37294","name":"P/0060/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for aprepitant (Emend), (EMEA-000144-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/103532/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0060-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-aprepitant-emend-emea-000144-pip01-07-m04_en.pdf"},
    {"id":"37306","name":"P/0264/2012: EMA decision of of 20 November 2012 on the acceptance of a modification of an agreed paediatric investigation plan for methoxyflurane (EMEA-000334-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/646936/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0264-2012-ema-decision-20-november-2012-acceptance-modification-agreed-paediatric-investigation-plan-methoxyflurane-emea-000334-pip01-08-m02_en.pdf"},
    {"id":"37333","name":"P/0353/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lubiprostone\n\n(Amitiza), (EMEA-000245-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/724547/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0353-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-lubiprostone-amitiza-emea-000245-pip01-08-m04_en.pdf"},
    {"id":"37335","name":"P/0230/2014: EMA decision of 5 September 2014 on the refusal of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (H5N1 or H1N1 strains) (Focetria and associated names, Afluno...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/464766/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2014-ema-decision-5-september-2014-refusal-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-h5n1-or-h1n1-strains-focetria-associated-names-afluno_en.pdf"},
    {"id":"37348","name":"P/0162/2013: EMA decision of 29 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for etravirine (Intelence) (EMEA-000222-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-02T13:15:00Z","last_updated_date":"2013-09-02T13:15:00Z","reference_number":"EMA/392989/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2013-ema-decision-29-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-etravirine-intelence-emea-000222-pip01-08-m07_en.pdf"},
    {"id":"37351","name":"P/0088/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for niraparib (EMEA-002268-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/105604/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0088-2018-ema-decision-16-march-2018-granting-product-specific-waiver-niraparib-emea-002268-pip01-17_en.pdf"},
    {"id":"37360","name":"P/0086/2013: EMA decision of 29 April 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for denosumab (Prolia, Xgeva) (EMEA-000145-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/180448/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0086-2013-ema-decision-29-april-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-denosumab-prolia-xgeva-emea-000145-pip02-12_en.pdf"},
    {"id":"37375","name":"P/0016/2012: EMA decision of 25 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/36974/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2012-ema-decision-25-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-emea-000332-pip01-08-m05_en.pdf"},
    {"id":"37389","name":"P/0107/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for lenvatinib (LENVIMA,\n\nKisplyx), (EMEA-001119-PIP02-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/164271/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0107-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-lenvatinib-lenvima-kisplyx-emea-001119-pip02-12-m03_en.pdf"},
    {"id":"37392","name":"P/0301/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ceftaroline fosamil (Zinforo), (EMEA-000769-PIP01-09-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/773328/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0301-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-ceftaroline-fosamil-zinforo-emea-000769-pip01-09-m05_en.pdf"},
    {"id":"37440","name":"P/0289/2012: EMA decision of 7 December 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for posaconazole (Noxafil) (EMEA-000468-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T10:40:00Z","last_updated_date":"2013-02-08T10:40:00Z","reference_number":"EMA/756036/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0289-2012-ema-decision-7-december-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-posaconazole-noxafil-emea-000468-pip02-12_en.pdf"},
    {"id":"37443","name":"P/0251/2016: EMA decision of 23 September 2016 on the acceptance of a modification of an agreed paediatric investigation plan for nusinersen (EMEA-\n\n001448-PIP01-13-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/576582/2016 Corr","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2016-ema-decision-23-september-2016-acceptance-modification-agreed-paediatric-investigation-plan-nusinersen-emea-001448-pip01-13-m02_en.pdf"},
    {"id":"37463","name":"P/0167/2017: EMA decision of 30 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dimethyl fumarate\n\n(Tecfidera), (EMEA-000832-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/370819/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2017-ema-decision-30-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-dimethyl-fumarate-tecfidera-emea-000832-pip01-10-m04_en.pdf"},
    {"id":"37470","name":"P/0106/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella), (EMEA-000927-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201050/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-linaclotide-constella-emea-000927-pip01-10-m01_en.pdf"},
    {"id":"37474","name":"P/161/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ciclosporin (EMEA-\n\n000575-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/417834/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-161-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-ciclosporin-emea-000575-pip01-09-m01_en.pdf"},
    {"id":"37475","name":"P/0021/2014: EMA decision of 22 January 2014 on the agreement of a paediatric investigation plan and on the granting of a waiver for mesalazine / prednisolone metasulphobenzoate (EMEA-001406-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-20T01:00:00Z","last_updated_date":"2014-02-20T01:00:00Z","reference_number":"EMA/775440/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2014-ema-decision-22-january-2014-agreement-paediatric-investigation-plan-granting-waiver-mesalazine-prednisolone-metasulphobenzoate-emea-001406-pip01-12_en.pdf"},
    {"id":"37561","name":"P/105/2011: EMA decision of 4 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for everolimus (Certican\n\nand associated names) (EMEA-000019-PIP06-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/325926/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-105-2011-ema-decision-4-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-everolimus-certican-associated-names-emea-000019-pip06-09-m01_en.pdf"},
    {"id":"37591","name":"P/0296/2012: EMA decision of 18 December 2012 on the granting of a product-specific waiver for elagolix (EMEA-001323-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T14:00:00Z","last_updated_date":"2013-02-08T14:00:00Z","reference_number":"EMA/802225/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0296-2012-ema-decision-18-december-2012-granting-product-specific-waiver-elagolix-emea-001323-pip01-12_en.pdf"},
    {"id":"37600","name":"P/41/2009: European Medicines Agency decision of 23 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for cannabidiol, delta-9-tetrahydrocannabinol (EMEA-000181-PIP01-08) in...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/162839/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-41-2009-european-medicines-agency-decision-23-march-2009-agreement-paediatric-investigation-plan-granting-deferral-cannabidiol-delta-9-tetrahydrocannabinol-emea-000181-pip01-08_en.pdf"},
    {"id":"37602","name":"P/92/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral for Human Cell\n\nLine recombinant human Factor VIII (human-cl rhFVIII), (EMEA-001024-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/193400/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-92-2011-ema-decision-8-april-2011-agreement-paediatric-investigation-plan-granting-deferral-human-cell-line-recombinant-human-factor-viii-human-cl-rhfviii-emea-001024-pip01-10_en.pdf"},
    {"id":"37607","name":"P/0264/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for Diphtheria toxoid / Tetanus toxoid / Bordetella pertussis antigen: Pertussis toxoid / Bordet...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/597534/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0264-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-diphtheria-toxoid-tetanus-toxoid-bordetella-pertussis-antigen-pertussis-toxoid-bordet_en.pdf"},
    {"id":"37622","name":"P/0187/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for raltegravir (Isentress) (EMEA-000279-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-23T02:00:00Z","last_updated_date":"2015-10-23T02:00:00Z","reference_number":"EMA/568917/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-raltegravir-isentress-emea-000279-pip01-08-m04_en.pdf"},
    {"id":"37626","name":"P/0307/2012: EMA decision of 21 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag (Revolade), (EMEA-000170-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-07T13:30:00Z","last_updated_date":"2013-02-07T13:30:00Z","reference_number":"EMA/795942/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2012-ema-decision-21-december-2012-acceptance-modification-agreed-paediatric-investigation-plan-eltrombopag-revolade-emea-000170-pip01-07-m03_en.pdf"},
    {"id":"37639","name":"P/0256/2016: EMA decision of 5 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for reslizumab (EMEA-\n\n001202-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/585769/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2016-ema-decision-5-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-reslizumab-emea-001202-pip02-13-m01_en.pdf"},
    {"id":"37642","name":"P/0079/2014: EMA decision of 2 April 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sirolimus (EMEA-001416-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2014-05-13T02:00:00Z","reference_number":"EMA/113590/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2014-ema-decision-2-april-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sirolimus-emea-001416-pip01-12_en.pdf"},
    {"id":"37644","name":"P/0255/2012: EMA decision of 26 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (Brilique, Possia), (EMEA-000480-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/672476/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0255-2012-ema-decision-26-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-brilique-possia-emea-000480-pip01-08-m04_en.pdf"},
    {"id":"37654","name":"P/0258/2014: EMA decision of 1 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tedizolid (phosphate) (EMEA-001379-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/514192/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0258-2014-ema-decision-1-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-tedizolid-phosphate-emea-001379-pip01-12-m01_en.pdf"},
    {"id":"37662","name":"P/0249/2014: EMA decision of 30 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir (disoproxil fumarate) (Viread), (EMEA-000533-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/519894/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0249-2014-ema-decision-30-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-tenofovir-disoproxil-fumarate-viread-emea-000533-pip01-08-m05_en.pdf"},
    {"id":"37668","name":"P/0216/2014: EMA decision of 3 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (EMEA-000576-PIP02-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/453841/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2014-ema-decision-3-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-emea-000576-pip02-11-m03_en.pdf"},
    {"id":"37672","name":"P/0115/2012: EMA decision of 2 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ipilimumab (Yervoy), (EMEA-000117-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/405302/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0115-2012-ema-decision-2-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-ipilimumab-yervoy-emea-000117-pip01-07-m04_en.pdf"},
    {"id":"37679","name":"P/0205/2014: EMA decision of 8 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant parathyroid hormone (EMEA-001526-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/414997/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2014-ema-decision-8-august-2014-agreement-paediatric-investigation-plan-granting-deferral-recombinant-parathyroid-hormone-emea-001526-pip01-13_en.pdf"},
    {"id":"37680","name":"P/255/2010:  EMA decision of 26 November 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for aluminium hydroxide adsorbed, depigmented glutaralde...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-12-21T01:00:00Z","last_updated_date":"2010-12-21T01:00:00Z","reference_number":"EMA/670695/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-255-2010-ema-decision-26-november-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aluminium-hydroxide-adsorbed-depigmented-glutaralde_en.pdf"},
    {"id":"37698","name":"P/0159/2013: EMA decision of 5 July 2013 on the granting of a product-specific waiver for ixazomib (citrate) (EMEA-001410-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-13T17:30:00Z","last_updated_date":"2013-08-13T17:30:00Z","reference_number":"EMA/332034/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2013-ema-decision-5-july-2013-granting-product-specific-waiver-ixazomib-citrate-emea-001410-pip01-12_en.pdf"},
    {"id":"37709","name":"P/47/2012: EMA decision of 29 February 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for fibrinogen concentrate / thrombin preparation / aprotinin / calcium chloride (EMEA-001...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-03-26T17:00:00Z","last_updated_date":"2012-03-26T17:00:00Z","reference_number":"EMA/129779/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-47-2012-ema-decision-29-february-2012-agreement-paediatric-investigation-plan-granting-deferral-fibrinogen-concentrate-thrombin-preparation-aprotinin-calcium-chloride-emea-001_en.pdf"},
    {"id":"37727","name":"P/0213/2016: EMA decision of 12 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (EMEA-\n\n001214-PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/501681/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2016-ema-decision-12-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-emea-001214-pip01-11-m05_en.pdf"},
    {"id":"37740","name":"P/0209/2014: EMA decision of 11 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for propan-2-yl N-[(S)-({[(2R)-1-(6-amino-9H-purin-9-yl)pr...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/464751/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2014-ema-decision-11-august-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-propan-2-yl-n-s-2r-1-6-amino-9h-purin-9-ylpr_en.pdf"},
    {"id":"37741","name":"P/0049/2018: EMA decision of 22 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo),\n\n(EMEA-001407-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/101776/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0049-2018-ema-decision-22-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-nivolumab-opdivo-emea-001407-pip01-12-m01_en.pdf"},
    {"id":"37743","name":"P/43/2010: EMA decision of 11 February 2011 on the acceptance of a modification of an agreed paediatric investigation plan for etravirine (Intelence) (EMEA-000222-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-03-08T01:00:00Z","last_updated_date":"2011-03-08T01:00:00Z","reference_number":"EMA/100929/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-43-2010-ema-decision-11-february-2011-acceptance-modification-agreed-paediatric-investigation-plan-etravirine-intelence-emea-000222-pip01-08-m03_en.pdf"},
    {"id":"37775","name":"P/249/2011: EMA decision of 25 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for Japanese encephalitis vaccine (inactivated, adsorbed) (Ixiaro), (EMEA-000559-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T17:00:00Z","last_updated_date":"2011-11-30T17:00:00Z","reference_number":"EMA/751064/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-249-2011-ema-decision-25-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-japanese-encephalitis-vaccine-inactivated-adsorbed-ixiaro-emea-000559-pip01-09-m03_en.pdf"},
    {"id":"37782","name":"P/0040/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for pegylated human interferon beta-1a (Plegridy) (EMEA-001129-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/80317/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0040-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-pegylated-human-interferon-beta-1a-plegridy-emea-001129-pip01-11-m01_en.pdf"},
    {"id":"37789","name":"P/0355/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol\n\n(hydrochloride) (Palexia and associated names, Yantil and associated names, Tape...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/704024/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0355-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-associated-names-yantil-associated-names-tape_en.pdf"},
    {"id":"37816","name":"P/0085/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) (Foclivia an...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/104851/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0085-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-waiver-pandemic-influenza-vaccine-h5n1-surface-antigen-inactivated-adjuvanted-foclivia_en.pdf"},
    {"id":"37818","name":"P/0010/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for reslizumab\n\n(Cinqaero), (EMEA-001202-PIP02-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-18T02:00:00Z","last_updated_date":"2018-04-18T02:00:00Z","reference_number":"EMA/792967/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-reslizumab-cinqaero-emea-001202-pip02-13-m02_en.pdf"},
    {"id":"37832","name":"P/136/2011: EMA decision of 10 June 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal\n\nof a waiver for edoxaban (tosylate) (EMEA-000788-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-07-14T02:00:00Z","last_updated_date":"2011-07-14T02:00:00Z","reference_number":"EMA/356126/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-136-2011-ema-decision-10-june-2011-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-edoxaban-tosylate-emea-000788-pip02-11_en.pdf"},
    {"id":"37843","name":"P/294/2011: EMA decision of 20 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for bosentan\n\nmonohydrate (Tracleer), (EMEA-000425-PIP02-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-18T17:45:00Z","last_updated_date":"2012-01-18T17:45:00Z","reference_number":"EMA/912642/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-294-2011-ema-decision-20-december-2011-acceptance-modification-agreed-paediatric-investigation-plan-bosentan-monohydrate-tracleer-emea-000425-pip02-10-m01_en.pdf"},
    {"id":"37849","name":"P/30/2011: EMA decision of 28 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (EMEA-000480-PIP01-08-M01) in accordance with Regulation (EC) No 1901/2006 of the E...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-23T01:00:00Z","last_updated_date":"2011-02-23T01:00:00Z","reference_number":"EMA/37980/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-30-2011-ema-decision-28-january-2011-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-emea-000480-pip01-08-m01-accordance-regulation-ec-no-1901-2006-e_en.pdf"},
    {"id":"37872","name":"P/0098/2014: EMA decision of 10 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/169115/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0098-2014-ema-decision-10-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-atazanavir-sulphate-reyataz-emea-000804-pip01-09-m02_en.pdf"},
    {"id":"37886","name":"P/0082/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a waiver for tetracaine (hydrochloride) / oxymetazoline (hydrochloride) (EMEA-001764-PIP03-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/131632/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0082-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-waiver-tetracaine-hydrochloride-oxymetazoline-hydrochloride-emea-001764-pip03-15_en.pdf"},
    {"id":"37887","name":"P/0206/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for semaglutide\n\n(EMEA-001441-PIP02-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/460851/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0206-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-semaglutide-emea-001441-pip02-15-m01_en.pdf"},
    {"id":"37890","name":"P/0212/2012: EMA decision of 28 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole\n\nmedocaril sodium (EMEA-000205-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/605951/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2012-ema-decision-28-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-ceftobiprole-medocaril-sodium-emea-000205-pip01-08-m01_en.pdf"},
    {"id":"37899","name":"P/0064/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for osilodrostat (EMEA-000315-PIP02-15-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/107501/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-osilodrostat-emea-000315-pip02-15-m01_en.pdf"},
    {"id":"37903","name":"P/0314/2014: EMA decision of 24 November 2014 on the acceptance of a modification of an agreed paediatric investigation plan for heterologous human adult liver-derived progenitor cells (HHALPC) (EMEA-001155-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-12T01:00:00Z","last_updated_date":"2014-12-12T01:00:00Z","reference_number":"EMA/651534/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0314-2014-ema-decision-24-november-2014-acceptance-modification-agreed-paediatric-investigation-plan-heterologous-human-adult-liver-derived-progenitor-cells-hhalpc-emea-001155-pip01-11-m02_en.pdf"},
    {"id":"37908","name":"P/121/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for treprostinil, (Remodulin and associated names) (EMEA-000207-PIP01-08) in accordanc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/626169/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-121-2008-european-medicines-agency-decision-1-december-2008-application-agreement-paediatric-investigation-plan-treprostinil-remodulin-associated-names-emea-000207-pip01-08-accordanc_en.pdf"},
    {"id":"37910","name":"P/0186/2013: EMA decision of 2 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir (EMEA-000968-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-09T18:20:00Z","last_updated_date":"2013-09-09T18:20:00Z","reference_number":"EMA/466730/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2013-ema-decision-2-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-emea-000968-pip02-11-m02_en.pdf"},
    {"id":"37925","name":"P/0143/2012: EMA decision of 23 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for propranolol\n\nhydrochloride (000511-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/471665/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2012-ema-decision-23-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-propranolol-hydrochloride-000511-pip01-08-m03_en.pdf"},
    {"id":"37953","name":"P/0142/2013: EMA decision of 3 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for icatibant acetate (Firazyr), (EMEA-000408-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-08T18:00:00Z","last_updated_date":"2013-08-08T18:00:00Z","reference_number":"EMA/306450/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2013-ema-decision-3-july-2013-acceptance-modification-agreed-paediatric-investigation-plan-icatibant-acetate-firazyr-emea-000408-pip01-08-m04_en.pdf"},
    {"id":"37973","name":"P/0010/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for ranibizumab\n\n(Lucentis), (EMEA-000527-PIP04-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/38628/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-ranibizumab-lucentis-emea-000527-pip04-13-m01_en.pdf"},
    {"id":"37984","name":"P/0101/2014: EMA decision of 11 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tiotropium bromide (monohydrate) (Spiriva Respimat, Spiriva), (EMEA-000035-PIP02-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2014-05-13T02:00:00Z","reference_number":"EMA/195557/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2014-ema-decision-11-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-tiotropium-bromide-monohydrate-spiriva-respimat-spiriva-emea-000035-pip02-09-m01_en.pdf"},
    {"id":"37991","name":"P/0401/2017: EMA decision of 19 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for blinatumomab\n\n(Blincyto), (EMEA-000574-PIP02-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/771128/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0401-2017-ema-decision-19-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-blinatumomab-blincyto-emea-000574-pip02-12-m02_en.pdf"},
    {"id":"37994","name":"P/0220/2016: EMA decision of 26 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (Orkambi), (EMEA-001582-PIP01-13-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-27T02:00:00Z","last_updated_date":"2016-06-27T02:00:00Z","reference_number":"EMA/441054/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2016-ema-decision-26-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-lumacaftor-ivacaftor-orkambi-emea-001582-pip01-13-m04_en.pdf"},
    {"id":"38013","name":"P/0313/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for elbasvir (EMEA-001603-PIP01-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/761386/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0313-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-elbasvir-emea-001603-pip01-13-m01_en.pdf"},
    {"id":"38024","name":"P/0131/2014: EMA decision of 10 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa (Ruconest) (EMEA-000367-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-15T02:00:00Z","last_updated_date":"2014-07-15T02:00:00Z","reference_number":"EMA/273853/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0131-2014-ema-decision-10-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-conestat-alfa-ruconest-emea-000367-pip01-08-m03_en.pdf"},
    {"id":"38044","name":"P/335/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for aqueous allergen extract of pollen from phleum prate...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/810422/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-335-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-aqueous-allergen-extract-pollen-phleum-prate_en.pdf"},
    {"id":"38069","name":"P/180/2010: European Medicines Agency decision of of 24 Septemeber 2010 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara), (EMEA-000311-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/587450/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-180-2010-european-medicines-agency-decision-24-septemeber-2010-acceptance-modification-agreed-paediatric-investigation-plan-ustekinumab-stelara-emea-000311-pip01-08-m01_en.pdf"},
    {"id":"38080","name":"P/0243/2013: EMA decision of 27 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for Clostridium difficile toxin A human monoclonal antibody / Clostridium difficile tox...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/582624/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2013-ema-decision-27-september-2013-agreement-paediatric-investigation-plan-granting-deferral-clostridium-difficile-toxin-human-monoclonal-antibody-clostridium-difficile-tox_en.pdf"},
    {"id":"38084","name":"P/0034/2017: European Medicines Agency decision of 30 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for Fc- and CDR-modified humanized monoclonal antibody against C5 (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/2916/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0034-2017-european-medicines-agency-decision-30-january-2017-agreement-paediatric-investigation-plan-granting-deferral-fc-cdr-modified-humanized-monoclonal-antibody-against-c5_en.pdf"},
    {"id":"38096","name":"P/0081/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral for tremelimumab\n\n(EMEA-002029-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/75600/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0081-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-tremelimumab-emea-002029-pip01-16_en.pdf"},
    {"id":"38106","name":"P/0310/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for obeticholic acid (6 alpha-ethylchenodeoxycholic acid) (EMEA-001304-PIP02-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-04T01:00:00Z","last_updated_date":"2016-02-04T01:00:00Z","reference_number":"EMA/785819/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0310-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-obeticholic-acid-6-alpha-ethylchenodeoxycholic-acid-emea-001304-pip02-13-m02_en.pdf"},
    {"id":"38116","name":"P/0068/2014: EMA decision of 14 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for glycerol phenylbutyrate (EMEA-000297-PIP02-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/122586/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2014-ema-decision-14-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-glycerol-phenylbutyrate-emea-000297-pip02-12-m01_en.pdf"},
    {"id":"38121","name":"P/0245/2017: EMA decision of 4 September 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for salmeterol (xinafoate) / fluticasone (propionate) (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-24T02:00:00Z","last_updated_date":"2017-10-24T02:00:00Z","reference_number":"EMA/497687/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2017-ema-decision-4-september-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-salmeterol-xinafoate-fluticasone-propionate-eme_en.pdf"},
    {"id":"38132","name":"P/277/2010: EMA decision of 3 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for allergen extract of 50% grass (equal parts of lolium ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-11T01:00:00Z","last_updated_date":"2011-01-11T01:00:00Z","reference_number":"EMA/754263/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-277-2010-ema-decision-3-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-allergen-extract-50-grass-equal-parts-lolium_en.pdf"},
    {"id":"38134","name":"P/0138/2014: EMA decision of 11 June 2014 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant fusion protein linking human coagulation factor IX with human albumin (EMEA-001107-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-28T02:00:00Z","last_updated_date":"2014-07-28T02:00:00Z","reference_number":"EMA/268695/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2014-ema-decision-11-june-2014-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-fusion-protein-linking-human-coagulation-factor-ix-human-albumin-emea-001107_en.pdf"},
    {"id":"38142","name":"P/127/2008: European Medicines Agency decision of 23 December 2008 on the application for agreement of a Paediatric Investigation Plan for telaprevir (EMEA-000196-PIP01-08) in accordance with Regulation (EC) No 1901/2006...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/671617/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-127-2008-european-medicines-agency-decision-23-december-2008-application-agreement-paediatric-investigation-plan-telaprevir-emea-000196-pip01-08-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"38145","name":"European Medicines Agency decision P/0040/2018 of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant Neisseria meningitides…(EMEA-000139-PIP01-07-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T13:35:00Z","last_updated_date":"2018-04-17T13:35:00Z","reference_number":"EMA/77586/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/european-medicines-agency-decision-p-0040-2018-16-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-neisseria-meningitidesemea-000139-pip01-07-m02_en.pdf"},
    {"id":"38151","name":"P/0381/2017: EMA decision of 19 December 2017 on the agreement of a paediatric investigation plan and on the granting of a waiver for susoctocog alfa (Obizur), (EMEA-000753-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/759392/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0381-2017-ema-decision-19-december-2017-agreement-paediatric-investigation-plan-granting-waiver-susoctocog-alfa-obizur-emea-000753-pip02-16_en.pdf"},
    {"id":"38169","name":"P/0113/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for rituximab\n\n(Mabthera), (EMEA-000308-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/155548/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-rituximab-mabthera-emea-000308-pip01-08-m03_en.pdf"},
    {"id":"38171","name":"P/0192/2013: EMA decision of 15 August 2013 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine (hydrochloride) (Edurant) (EMEA-000317-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-09-11T11:20:00Z","last_updated_date":"2013-09-11T11:20:00Z","reference_number":"EMA/484532/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2013-ema-decision-15-august-2013-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-hydrochloride-edurant-emea-000317-pip01-08-m04_en.pdf"},
    {"id":"38186","name":"P/0136/2015: EMA decision of 15 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for eribulin (Halaven), (EMEA-001261-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-07T02:00:00Z","last_updated_date":"2015-07-07T02:00:00Z","reference_number":"EMA/384474/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2015-ema-decision-15-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-eribulin-halaven-emea-001261-pip01-11-m02_en.pdf"},
    {"id":"38193","name":"P/0089/2018: EMA decision of 16 March 2018 on the granting of a product- specific waiver for trazodone (hydrochloride) / gabapentin (EMEA-002263-\n\nPIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/87985/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2018-ema-decision-16-march-2018-granting-product-specific-waiver-trazodone-hydrochloride-gabapentin-emea-002263-pip01-17_en.pdf"},
    {"id":"38211","name":"P/0200/2013: EMA decision of 2 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for pitolisant (hydrochloride), (EMEA-001176-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/483374/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0200-2013-ema-decision-2-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-pitolisant-hydrochloride-emea-001176-pip01-11-m01_en.pdf"},
    {"id":"38221","name":"P/0242/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for brivaracetam (EMEA-000332-PIP01-08-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/617380/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-brivaracetam-emea-000332-pip01-08-m09_en.pdf"},
    {"id":"38222","name":"P/0003/2013: EMA decision of 21 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza), (EMEA-000128-PIP01-07-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/19766/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0003-2013-ema-decision-21-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m05_en.pdf"},
    {"id":"38227","name":"P/0215/2013: EMA decision of 4 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for daclizumab (EMEA-001349-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/519897/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2013-ema-decision-4-september-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-daclizumab-emea-001349-pip01-12_en.pdf"},
    {"id":"38230","name":"P/85/2009: European medicines agency decision of 18 May 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for tigecycline (Tygacil), (EMEA-000120-PIP01-07-M01) in accordance with Regulat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/272680/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-85-2009-european-medicines-agency-decision-18-may-2009-acceptance-modification-agreed-paediatric-investigation-plan-tigecycline-tygacil-emea-000120-pip01-07-m01-accordance-regulat_en.pdf"},
    {"id":"38231","name":"P/0254/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for riociguat (EMEA-\n\n000718-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/662557/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0254-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-riociguat-emea-000718-pip01-09-m02_en.pdf"},
    {"id":"38273","name":"P/0075/2013: EMA decision of 26 March 2013 on the granting of a product-specific waiver for alendronic acid / colecalciferol (EMEA-001327-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/114867/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2013-ema-decision-26-march-2013-granting-product-specific-waiver-alendronic-acid-colecalciferol-emea-001327-pip01-12_en.pdf"},
    {"id":"38285","name":"P/0082/2015: EMA decision of 10 April 2015 on the agreement of a paediatric investigation plan for recombinant human N-acetylglucosaminidase (rhNAGLU) (EMEA-001653-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-19T02:00:00Z","last_updated_date":"2015-05-19T02:00:00Z","reference_number":"EMA/227590/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0082-2015-ema-decision-10-april-2015-agreement-paediatric-investigation-plan-recombinant-human-n-acetylglucosaminidase-rhnaglu-emea-001653-pip01-14_en.pdf"},
    {"id":"38312","name":"P/0157/2014: EMA decision of 18 June 2014 on the granting of a product specific waiver for clarithromycin (in combination with amoxicillin + metronidazole + pantoprazole) (EMEA-001614-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/259616/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2014-ema-decision-18-june-2014-granting-product-specific-waiver-clarithromycin-combination-amoxicillin-metronidazole-pantoprazole-emea-001614-pip01-13_en.pdf"},
    {"id":"38321","name":"P/0195/2012: EMA decision of 24 August 2012 on the granting of a product specific waiver for co-crystal of tramadol (hydrochloride) / celecoxib\n\n(EMEA-001279-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T13:30:00Z","last_updated_date":"2012-09-18T13:30:00Z","reference_number":"EMA/547672/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0195-2012-ema-decision-24-august-2012-granting-product-specific-waiver-co-crystal-tramadol-hydrochloride-celecoxib-emea-001279-pip01-12_en.pdf"},
    {"id":"38327","name":"P/0157/2012: EMA decision of 25 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for velaglucerase alfa (EMEA-000556-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/475821/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2012-ema-decision-25-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-velaglucerase-alfa-emea-000556-pip01-09-m02_en.pdf"},
    {"id":"38351","name":"P/96/2011: EMA decision of 8 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for insulin degludec / insulin aspart (EMEA-000479-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/247853/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-96-2011-ema-decision-8-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-insulin-degludec-insulin-aspart-emea-000479-pip01-08-m01_en.pdf"},
    {"id":"38366","name":"P/0274/2016: EMA decision of 7 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eftrenonacog alfa\n\n(ALPROLIX), (EMEA-000914-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/631038/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0274-2016-ema-decision-7-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-eftrenonacog-alfa-alprolix-emea-000914-pip01-10-m03_en.pdf"},
    {"id":"38376","name":"P/90/2009: European medicines agency decision of 18 May 2009 on the refusal of a Paediatric Investigation Plan and on the granting of a waiver for drospirenone / ethinylestradiol, betadex clathrate / L-5 methyltetrahydro...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/272662/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-90-2009-european-medicines-agency-decision-18-may-2009-refusal-paediatric-investigation-plan-granting-waiver-drospirenone-ethinylestradiol-betadex-clathrate-l-5-methyltetrahydro_en.pdf"},
    {"id":"38378","name":"P/0214/2014: EMA decision of 1 September 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ertugliflozin (EMEA-001533-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-30T02:00:00Z","last_updated_date":"2014-09-30T02:00:00Z","reference_number":"EMA/464759/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2014-ema-decision-1-september-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ertugliflozin-emea-001533-pip01-13_en.pdf"},
    {"id":"38389","name":"P/0299/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for C1 inhibitor (human) (Cinryze) (EMEA-000568-PIP01-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/792884/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-c1-inhibitor-human-cinryze-emea-000568-pip01-09-m06_en.pdf"},
    {"id":"38403","name":"P/0089/2016: EMA decision of 22 March 2016 on the granting of a product specific waiver for azithromycin / miconazole / sulfamethoxazole (EMEA-001769-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/104847/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0089-2016-ema-decision-22-march-2016-granting-product-specific-waiver-azithromycin-miconazole-sulfamethoxazole-emea-001769-pip01-15_en.pdf"},
    {"id":"38419","name":"P/235/2009: European Medicines Agency Decision of 27 November 2009 on the granting of a product specific waiver for simvastatin / ramipril / acetyl salicylic acid (EMEA-000631-PIP01-09) in accordance with Regulation (EC)...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-12-23T00:09:21Z","last_updated_date":"2009-12-23T00:09:21Z","reference_number":"EMEA/748470/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-235-2009-european-medicines-agency-decision-27-november-2009-granting-product-specific-waiver-simvastatin-ramipril-acetyl-salicylic-acid-emea-000631-pip01-09-accordance-regulation-ec_en.pdf"},
    {"id":"38447","name":"P/0201/2012: EMA decision of 24 August 2012 on the granting of a product specific waiver for recombinant human antibody against activin type IIB\n\nreceptors (EMEA-001286-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T14:00:00Z","last_updated_date":"2012-09-18T14:00:00Z","reference_number":"EMA/534269/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2012-ema-decision-24-august-2012-granting-product-specific-waiver-recombinant-human-antibody-against-activin-type-iib-receptors-emea-001286-pip01-12_en.pdf"},
    {"id":"38459","name":"P/105/2012: EMA decision of 4 June 2012 on the acceptance of a modification of an agreed paediatric investigation plan for tiotropium bromide (monohydrate) (Spiriva Respimat and associated names, Spiriva), (EMEA-000035-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-07-23T17:00:00Z","last_updated_date":"2012-07-23T17:00:00Z","reference_number":"EMA/285017/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-105-2012-ema-decision-4-june-2012-acceptance-modification-agreed-paediatric-investigation-plan-tiotropium-bromide-monohydrate-spiriva-respimat-associated-names-spiriva-emea-000035-p_en.pdf"},
    {"id":"38462","name":"P/0117/2018: EMA decision of 11 April 2018 on the granting of a product specific waiver for polatuzumab vedotin (EMEA-002255-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-07-25T02:00:00Z","last_updated_date":"2018-07-25T02:00:00Z","reference_number":"EMA/141773/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0117-2018-ema-decision-11-april-2018-granting-product-specific-waiver-polatuzumab-vedotin-emea-002255-pip01-17_en.pdf"},
    {"id":"38476","name":"P/123/2009: European Medicines Agency decision of 12 June 2009 on the acceptance of a modification of an agreed Paediatric Investigation Plan for rosuvastatin calcium (EMEA-000022-PIP01-07-M02) in accordance with Regulat...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/348182/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-123-2009-european-medicines-agency-decision-12-june-2009-acceptance-modification-agreed-paediatric-investigation-plan-rosuvastatin-calcium-emea-000022-pip01-07-m02-accordance-regulat_en.pdf"},
    {"id":"38479","name":"P/0247/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP01-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/617377/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip01-09-m06_en.pdf"},
    {"id":"38508","name":"P/0186/2017: EMA decision of 30 June 2017 on the granting of a product-specific waiver for rosuvastatin (calcium) / ezetimibe (EMEA-002131-\n\nPIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/371179/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2017-ema-decision-30-june-2017-granting-product-specific-waiver-rosuvastatin-calcium-ezetimibe-emea-002131-pip01-17_en.pdf"},
    {"id":"38572","name":"P/0017/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for reslizumab (EMEA-001202-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/776144/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-reslizumab-emea-001202-pip02-13_en.pdf"},
    {"id":"38587","name":"P/0096/2017: EMA decision of 11 April 2017 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin\n\n(diphosphate) (Orbactiv), (EMEA-001270-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-05-29T02:00:00Z","last_updated_date":"2017-05-29T02:00:00Z","reference_number":"EMA/155550/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0096-2017-ema-decision-11-april-2017-acceptance-modification-agreed-paediatric-investigation-plan-oritavancin-diphosphate-orbactiv-emea-001270-pip01-12-m01_en.pdf"},
    {"id":"38598","name":"P/0266/2016: EMA decision of 5 October 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for ragweed pollen extract (Ambrosia artemisiifolia) (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/576571/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2016-ema-decision-5-october-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ragweed-pollen-extract-ambrosia-artemisiifolia-eme_en.pdf"},
    {"id":"38605","name":"P/119/2008: European Medicines Agency decision of 1 December 2008 on the application for agreement of a Paediatric Investigation Plan for Alipogene tiparvovec, EMEA-000292-PIP01-08 in accordance with Regulation (EC) No 1...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-01-29T01:00:00Z","last_updated_date":"2009-01-29T01:00:00Z","reference_number":"EMEA/620398/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-119-2008-european-medicines-agency-decision-1-december-2008-application-agreement-paediatric-investigation-plan-alipogene-tiparvovec-emea-000292-pip01-08-accordance-regulation-ec-no-1_en.pdf"},
    {"id":"38608","name":"P/0035/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (EMEA-000576-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/797036/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0035-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-emea-000576-pip01-09-m04_en.pdf"},
    {"id":"38611","name":"P/208/2010: EMEA decision on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1/Influenza virus surface an...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMA/615009/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-208-2010-emea-decision-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-h1n1-influenza-virus-surface_en.pdf"},
    {"id":"38620","name":"P/0009/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for raltegravir (Isentress), (EMEA-000279-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/793798/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0009-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-raltegravir-isentress-emea-000279-pip01-08-m03_en.pdf"},
    {"id":"38630","name":"P/0002/2018: EMA decision of 4 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for artenimol /\n\npiperaquine phosphate anhydride (Eurartesim), (EMEA-000153-PIP01-07-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T13:35:00Z","last_updated_date":"2018-04-17T13:35:00Z","reference_number":"EMA/517/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2018-ema-decision-4-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-artenimol-piperaquine-phosphate-anhydride-eurartesim-emea-000153-pip01-07-m05_en.pdf"},
    {"id":"38640","name":"P/0008/2013: EMA decision of 22 January 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-03T18:30:00Z","last_updated_date":"2013-04-03T18:30:00Z","reference_number":"EMA/20983/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2013-ema-decision-22-january-2013-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip01-09-m02_en.pdf"},
    {"id":"38651","name":"P/0139/2015: EMA decision of 10 July 2015 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (EMEA - 000069-PIP02-10-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-24T16:00:00Z","last_updated_date":"2015-08-24T16:00:00Z","reference_number":"EMA/366951/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2015-ema-decision-10-july-2015-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip02-10-m05_en.pdf"},
    {"id":"38670","name":"P/116/2011: EMA decision of 18 May 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for perflubutane (EMEA-000194-PIP03-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-09T02:00:00Z","last_updated_date":"2011-06-09T02:00:00Z","reference_number":"EMA/326597/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-116-2011-ema-decision-18-may-2011-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-perflubutane-emea-000194-pip03-10_en.pdf"},
    {"id":"38696","name":"P/64/2008: European medicines agency decision of 15 August 2008 on the application for agreement of a Paediatric Investigation Plan for peginterferon alfa-2b, PegIntron (EMEA-000071-PIP01-07) in accordance with Regulatio...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/424620/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-64-2008-european-medicines-agency-decision-15-august-2008-application-agreement-paediatric-investigation-plan-peginterferon-alfa-2b-pegintron-emea-000071-pip01-07-accordance-regulatio_en.pdf"},
    {"id":"38745","name":"P/0193/2015: EMA decision of 4 September 2015 on the acceptance of a modification of an agreed paediatric investigation plan for indacaterol (acetate) / mometasone (furoate) (EMEA-001217-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/505293/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2015-ema-decision-4-september-2015-acceptance-modification-agreed-paediatric-investigation-plan-indacaterol-acetate-mometasone-furoate-emea-001217-pip01-11-m01_en.pdf"},
    {"id":"38748","name":"P/0069/2012: EMA decision of 4 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (EMEA-000115-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-27T13:00:00Z","last_updated_date":"2012-04-27T13:00:00Z","reference_number":"EMA/202941/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0069-2012-ema-decision-4-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-emea-000115-pip01-07-m02_en.pdf"},
    {"id":"38754","name":"P/0260/2013: EMA decision of 29 October 2013 on the agreement of a paediatric investigation plan for recombinant human tripeptidyl peptidase-1 (EMEA-001362-PIP01-12)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/587131/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2013-ema-decision-29-october-2013-agreement-paediatric-investigation-plan-recombinant-human-tripeptidyl-peptidase-1-emea-001362-pip01-12_en.pdf"},
    {"id":"38756","name":"P/154/2009: EMEA decision of 11 August 2009\n\non the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for recombinant human monoclonal antibody to human interl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/492748/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-154-2009-emea-decision-11-august-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-human-monoclonal-antibody-human-interl_en.pdf"},
    {"id":"38762","name":"P/1/2010: European Medicines Agency decision of 25 January 2010\n\non the acceptance of a modification of an agreed Paediatric Investigation Plan\n\nfor Ulipristal acetate (EMEA-000305-PIP01-08-M01) in accordance with Regula...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-02-25T01:00:00Z","last_updated_date":"2010-02-25T01:00:00Z","reference_number":"EMEA/28385/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-1-2010-european-medicines-agency-decision-25-january-2010-acceptance-modification-agreed-paediatric-investigation-plan-ulipristal-acetate-emea-000305-pip01-08-m01-accordance-regula_en.pdf"},
    {"id":"38768","name":"P/111/2009: EMEA decision of 16 June 2009 on the agreement of a PIP and on the granting of a waiver for Human Papillomavirus1 Type6 L1 protein / Human Papillomavirus1 Type11 L1 protein /Human Papillomavirus1 Type16 L1 pr...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-08-11T02:00:00Z","last_updated_date":"2009-08-11T02:00:00Z","reference_number":"EMEA/351468/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-111-2009-emea-decision-16-june-2009-agreement-pip-granting-waiver-human-papillomavirus1-type6-l1-protein-human-papillomavirus1-type11-l1-protein-human-papillomavirus1-type16-l1-pr_en.pdf"},
    {"id":"38781","name":"P/97/2011: EMA decision of 8 April 2011 on the acceptance of a modification of an agreed paediatric investigation plan for saxagliptin (Onglyza), (EMEA-000200-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-05-12T02:00:00Z","last_updated_date":"2011-05-12T02:00:00Z","reference_number":"EMA/258007/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-97-2011-ema-decision-8-april-2011-acceptance-modification-agreed-paediatric-investigation-plan-saxagliptin-onglyza-emea-000200-pip01-08-m03_en.pdf"},
    {"id":"38788","name":"P/0063/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-26T02:00:00Z","last_updated_date":"2016-04-26T02:00:00Z","reference_number":"EMA/131043/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-dapagliflozin-forxiga-emea-000694-pip02-14-m01_en.pdf"},
    {"id":"38794","name":"P/0318/2015: EMA decision of 21 December 2015 on the granting of a product-specific waiver for telotristat etiprate (EMEA-001840-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/759754/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0318-2015-ema-decision-21-december-2015-granting-product-specific-waiver-telotristat-etiprate-emea-001840-pip01-15_en.pdf"},
    {"id":"38821","name":"P/0008/2015: EMA decision of 30 January 2015 on the granting of a product specific waiver for human papillomavirus type 18 L1 protein / human papillomavirus type 16 L1 protein (Cervarix), (EMEA-000234-PIP02-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/793136/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0008-2015-ema-decision-30-january-2015-granting-product-specific-waiver-human-papillomavirus-type-18-l1-protein-human-papillomavirus-type-16-l1-protein-cervarix-emea-000234-pip02-14_en.pdf"},
    {"id":"38833","name":"P/0314/2013: EMA decision of 19 December 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sodium N-{6-[3-tert-Butyl-5-(2,4-dioxo-3,4-dihydropy...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/693867/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0314-2013-ema-decision-19-december-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-sodium-n-6-3-tert-butyl-5-24-dioxo-34-dihydropy_en.pdf"},
    {"id":"38861","name":"P/0066/2016: EMA decision of 18 March 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for romosozumab (EMEA-001075-PIP04-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/139282/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2016-ema-decision-18-march-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-romosozumab-emea-001075-pip04-15_en.pdf"},
    {"id":"38865","name":"P/0055/2018: EMA decision of 9 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lanadelumab (DX-2930) (EMEA-001864-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/123907/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2018-ema-decision-9-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-lanadelumab-dx-2930-emea-001864-pip01-15-m02_en.pdf"},
    {"id":"38877","name":"P/0211/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for elvitegravir /\n\ncobicistat / emtricitabine / tenofovir alafenamide (Genvoya), (EMEA-001460-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-02T02:00:00Z","last_updated_date":"2017-10-02T02:00:00Z","reference_number":"EMA/459569/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-elvitegravir-cobicistat-emtricitabine-tenofovir-alafenamide-genvoya-emea-001460-pip_en.pdf"},
    {"id":"38889","name":"P/0011/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin\n\n(EMEA-000780-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/20904/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0011-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-midostaurin-emea-000780-pip01-09-m03_en.pdf"},
    {"id":"38900","name":"P/0005/2012: EMA decision of 23 January 2012 on the acceptance of a modification of an agreed paediatric investigation plan for aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergen extract of bi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-23T13:30:00Z","last_updated_date":"2012-02-23T13:30:00Z","reference_number":"EMA/972927/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2012-ema-decision-23-january-2012-acceptance-modification-agreed-paediatric-investigation-plan-aluminium-hydroxide-adsorbed-depigmented-glutaraldehyde-polymerised-allergen-extract-bi_en.pdf"},
    {"id":"38918","name":"P/0079/2012: EMA decision of 27 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (Gammagen) (EMEA-000415-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/253072/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2012-ema-decision-27-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-gammagen-emea-000415-pip01-08-m01_en.pdf"},
    {"id":"38920","name":"P/0125/2015: EMA decision of 5 June 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Norovirus GI.1 virus-like particle antigen / Norovirus GI...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T02:00:00Z","last_updated_date":"2015-07-03T02:00:00Z","reference_number":"EMA/284196/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2015-ema-decision-5-june-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-norovirus-gi1-virus-particle-antigen-norovirus-gi_en.pdf"},
    {"id":"38925","name":"P/0175/2015: EMA decision of 7 August 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atrasentan (hydrochloride) (EMEA-001666-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-22T02:00:00Z","last_updated_date":"2015-09-22T02:00:00Z","reference_number":"EMA/473934/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2015-ema-decision-7-august-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-atrasentan-hydrochloride-emea-001666-pip01-14_en.pdf"},
    {"id":"38930","name":"P/0019/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodi...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/12342/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-citric-acid-citric-acid-anhydrous-sodium-chloride-simeticone-macrogol-4000-sodi_en.pdf"},
    {"id":"38942","name":"P/0129/2016: EMA decision of 20 May 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (phosphate monohydrate) (TESAVEL) EMEA-000472-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-02-28T01:00:00Z","last_updated_date":"2017-02-28T01:00:00Z","reference_number":"EMA/295716/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2016-ema-decision-20-may-2016-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-tesavel-emea-000472-pip01-08-m02_en.pdf"},
    {"id":"38975","name":"P/259/2011: EMA decision of 26 October 2011 on the granting of a product specific waiver for brinzolamide / brimonidine (tartrate) (EMEA-001172-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-29T01:00:00Z","last_updated_date":"2011-11-29T01:00:00Z","reference_number":"EMA/764077/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-259-2011-ema-decision-26-october-2011-granting-product-specific-waiver-brinzolamide-brimonidine-tartrate-emea-001172-pip01-11_en.pdf"},
    {"id":"38987","name":"P/0321/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for urofollitropin (EMEA-001655-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T13:30:00Z","last_updated_date":"2015-02-23T13:30:00Z","reference_number":"EMA/755898/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0321-2014-ema-decision-19-december-2014-granting-product-specific-waiver-urofollitropin-emea-001655-pip01-14_en.pdf"},
    {"id":"39011","name":"P/0239/2013: EMA decision of 24 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for dabrafenib (mesilate) (EMEA-001147-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/496862/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2013-ema-decision-24-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-dabrafenib-mesilate-emea-001147-pip01-11-m01_en.pdf"},
    {"id":"39033","name":"P/0339/2017: EMA decision of 10 November 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pneumococcal polysaccharide serotype 1 – diphtheria...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-12T01:00:00Z","last_updated_date":"2018-02-12T01:00:00Z","reference_number":"EMA/710111/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0339-2017-ema-decision-10-november-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pneumococcal-polysaccharide-serotype-1-diphtheria_en.pdf"},
    {"id":"39034","name":"P/0333/2014: EMA decision of 22 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for serelaxin (EMEA-001168-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-02-23T01:00:00Z","last_updated_date":"2015-02-23T01:00:00Z","reference_number":"EMA/739522/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0333-2014-ema-decision-22-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-serelaxin-emea-001168-pip01-11-m02_en.pdf"},
    {"id":"39051","name":"P/0173/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sebelipase alfa (EMEA-001331-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/434301/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-sebelipase-alfa-emea-001331-pip01-12-m02_en.pdf"},
    {"id":"39059","name":"P/0061/2013: European medicines agency decision of 26 March 2013 on the acceptance of a modification of an agreed paediatric investigation plan for saxagliptin (Onglyza), (EMEA-000200-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-03T02:00:00Z","last_updated_date":"2013-05-03T02:00:00Z","reference_number":"EMA/103240/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0061-2013-european-medicines-agency-decision-26-march-2013-acceptance-modification-agreed-paediatric-investigation-plan-saxagliptin-onglyza-emea-000200-pip01-08-m04_en.pdf"},
    {"id":"39063","name":"P/0249/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Ya...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/619853/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0249-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-split-influenza-virus-inactivated-containing-antigens-equivalent-b-strain-b-ya_en.pdf"},
    {"id":"39079","name":"P/192/2011: EMA decision of 3 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for beclometasone dipropionate / formoterol fumarate dihydrate (Foster and associated names, Kantos...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/591812/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-192-2011-ema-decision-3-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-beclometasone-dipropionate-formoterol-fumarate-dihydrate-foster-associated-names-kantos_en.pdf"},
    {"id":"39092","name":"P/0036/2017: European Medicines Agency decision of 31 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for pegvaliase (EMEA-001951-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/12302/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2017-european-medicines-agency-decision-31-january-2017-agreement-paediatric-investigation-plan-granting-deferral-pegvaliase-emea-001951-pip01-16_en.pdf"},
    {"id":"39128","name":"P/0267/2015: EMA decision of 27 November 2015 on the acceptance of a modification of an agreed paediatric investigation plan for oseltamivir (phosphate) Tamiflu (EMEA-000365-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/764515/20015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2015-ema-decision-27-november-2015-acceptance-modification-agreed-paediatric-investigation-plan-oseltamivir-phosphate-tamiflu-emea-000365-pip01-08-m07_en.pdf"},
    {"id":"39134","name":"P/0184/2016: EMA decision of 15 July 2016 on the refusal of a modification of an agreed paediatric investigation plan for decitabine (Dacogen)\n\n(EMEA-000555-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/408586/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2016-ema-decision-15-july-2016-refusal-modification-agreed-paediatric-investigation-plan-decitabine-dacogen-emea-000555-pip01-09-m04_en.pdf"},
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    {"id":"39175","name":"P/0202/2012: EMA decision of 30 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (EMEA-000115-PIP01-07-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T13:20:00Z","last_updated_date":"2012-09-18T13:20:00Z","reference_number":"EMA/501091/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0202-2012-ema-decision-30-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-emea-000115-pip01-07-m03_en.pdf"},
    {"id":"39197","name":"P/0030/2014: European Medicines Agency decision of 21 February 2014\n\non the acceptance of a modification of an agreed paediatric investigation plan for (EMEA-000673-PIP01-09-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-03-20T01:00:00Z","last_updated_date":"2014-03-20T01:00:00Z","reference_number":"EMA/58694/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0030-2014-european-medicines-agency-decision-21-february-2014-acceptance-modification-agreed-paediatric-investigation-plan-emea-000673-pip01-09-m07_en.pdf"},
    {"id":"39208","name":"P/0016/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa\n\n(Ruconest) (EMEA-000367-PIP01-08-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T15:28:00Z","last_updated_date":"2018-04-17T15:28:00Z","reference_number":"EMA/28038/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0016-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-conestat-alfa-ruconest-emea-000367-pip01-08-m07_en.pdf"},
    {"id":"39225","name":"P/0149/2016: EMA decision of 14 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for efmorocotocog alfa\n\n(Elocta), (EMEA-001114-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-30T02:00:00Z","last_updated_date":"2016-08-30T02:00:00Z","reference_number":"EMA/334432/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2016-ema-decision-14-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-efmorocotocog-alfa-elocta-emea-001114-pip01-10-m03_en.pdf"},
    {"id":"39226","name":"P/0328/2017: EMA decision of 31 October 2017 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus\n\nsurface antigens (haemagglutinin and neuraminidase)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-02-20T01:00:00Z","last_updated_date":"2018-02-20T01:00:00Z","reference_number":"EMA/666631/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0328-2017-ema-decision-31-october-2017-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-surface-antigens-haemagglutinin-neuraminidase_en.pdf"},
    {"id":"39227","name":"P/0192/2014: EMA decision of 6 August 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (EMEA-001501-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/391491/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2014-ema-decision-6-august-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dupilumab-emea-001501-pip02-13_en.pdf"},
    {"id":"39237","name":"P/0092/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for sildenafil (Revatio), (EMEA-000671-PIP01-09-M07)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/215075/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0092-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-sildenafil-revatio-emea-000671-pip01-09-m07_en.pdf"},
    {"id":"39257","name":"P/0327/2014: EMA decision of 11 December 2014 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten and associated names) (EMEA-000347-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-01-22T01:00:00Z","last_updated_date":"2015-01-22T01:00:00Z","reference_number":"EMA/71305/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0327-2014-ema-decision-11-december-2014-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-associated-names-emea-000347-pip01-08-m04_en.pdf"},
    {"id":"39275","name":"P/0133/2017: EMA decision of 7 June 2017 on the granting of a product specific waiver for soybean oil/medium-chain triglycerides/olive oil/fish oil/acetyl-cysteine/alanine/arginine/glycine/histidine/isoleucin/leucine/lys...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/312725/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0133-2017-ema-decision-7-june-2017-granting-product-specific-waiver-soybean-oil-medium-chain-triglycerides-olive-oil-fish-oil-acetyl-cysteine-alanine-arginine-glycine-histidine-isoleucin-leucine-lys_en.pdf"},
    {"id":"39286","name":"P/0079/2017: EMA decision of 17 March 2017 on the granting of a product specific waiver for alpelisib (EMEA-002016-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/104983/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2017-ema-decision-17-march-2017-granting-product-specific-waiver-alpelisib-emea-002016-pip02-16_en.pdf"},
    {"id":"39296","name":"P/0226/2012: EMA decision of 3 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara) (EMEA-000311-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-11-23T01:00:00Z","reference_number":"EMA/616794/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2012-ema-decision-3-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-ustekinumab-stelara-emea-000311-pip01-08-m02_en.pdf"},
    {"id":"39316","name":"P/0007/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag\n\n(Revolade), (EMEA-000170-PIP03-13-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/12343/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-eltrombopag-revolade-emea-000170-pip03-13-m02_en.pdf"},
    {"id":"39320","name":"P/0050/2012: EMA decision of 2 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for guanfacine\n\n(hydrochloride) (EMEA-000745-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-10T02:00:00Z","last_updated_date":"2012-04-10T02:00:00Z","reference_number":"EMA/136005/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2012-ema-decision-2-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-guanfacine-hydrochloride-emea-000745-pip01-09-m01_en.pdf"},
    {"id":"39335","name":"P/172/2011: EMA decision of 4 July 2011 on the acceptance of a modification of an agreed paediatric investigation plan for coagulation factor IX\n\n(recombinant) (EMEA-000661-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-11T02:00:00Z","last_updated_date":"2011-08-11T02:00:00Z","reference_number":"EMA/485276/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-172-2011-ema-decision-4-july-2011-acceptance-modification-agreed-paediatric-investigation-plan-coagulation-factor-ix-recombinant-emea-000661-pip01-09-m03_en.pdf"},
    {"id":"39366","name":"P/0111/2015: EMA decision of 5 June 2015 on the acceptance of a modification of an agreed paediatric investigation plan for telavancin (hydrochloride) (Vibativ), (EMEA-000239-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-06T02:00:00Z","last_updated_date":"2015-07-06T02:00:00Z","reference_number":"EMA/296255/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0111-2015-ema-decision-5-june-2015-acceptance-modification-agreed-paediatric-investigation-plan-telavancin-hydrochloride-vibativ-emea-000239-pip01-08-m01_en.pdf"},
    {"id":"39397","name":"P/0138/2013: EMA decision of 21 June 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ataluren (3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic acid) (EMEA-000115-PIP02-09-M0...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-07-23T12:00:00Z","last_updated_date":"2013-07-23T12:00:00Z","reference_number":"EMA/330461/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2013-ema-decision-21-june-2013-acceptance-modification-agreed-paediatric-investigation-plan-ataluren-3-5-2-fluoro-phenyl-124oxadiazole-3-yl-benzoic-acid-emea-000115-pip02-09-m0_en.pdf"},
    {"id":"39410","name":"P/74/2010: European Medicines Agency decision of 5 May 2010 on the acceptance of a modification of an agreed paediatric investigation plan for Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown i...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-22T02:00:00Z","last_updated_date":"2010-07-22T02:00:00Z","reference_number":"EMA/249213/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-74-2010-european-medicines-agency-decision-5-may-2010-acceptance-modification-agreed-paediatric-investigation-plan-japanese-encephalitis-virus-inactivated-attenuated-strain-sa14-14-2-grown-i_en.pdf"},
    {"id":"39440","name":"P/0121/2017: EMA decision of 5 May 2017 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of\n\na waiver for recombinant modified human growth hormone (EMEA-001152-PIP02...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/250886/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2017-ema-decision-5-may-2017-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-recombinant-modified-human-growth-hormone-emea-001152-pip02_en.pdf"},
    {"id":"39441","name":"P/74/2009: European Medicines Agency decision of 20 April 2009 on the granting of a product specific waiver for Bismuth subcitrate potassium / Metronidazole / Tetracycline hydrochloride (EMEA-000382-PIP01-08) in accordan...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-06-10T02:00:00Z","last_updated_date":"2009-06-10T02:00:00Z","reference_number":"EMEA/230384/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-74-2009-european-medicines-agency-decision-20-april-2009-granting-product-specific-waiver-bismuth-subcitrate-potassium-metronidazole-tetracycline-hydrochloride-emea-000382-pip01-08-accordan_en.pdf"},
    {"id":"39485","name":"P/0245/2016: EMA decision of 12 September 2016 on the granting of a product specific waiver for amlodipine (besylate) / perindopril (erbumine) /\n\nindapamide (EMEA-001948-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/513669/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2016-ema-decision-12-september-2016-granting-product-specific-waiver-amlodipine-besylate-perindopril-erbumine-indapamide-emea-001948-pip01-16_en.pdf"},
    {"id":"39488","name":"P/19/2011: EMA decision of 25 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for sitagliptin (phosphate monohydrate) (Januvia), (EMEA-000470-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-30T01:09:21Z","last_updated_date":"2011-02-25T00:09:21Z","reference_number":"EMA/26024/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-19-2011-ema-decision-25-january-2011-acceptance-modification-agreed-paediatric-investigation-plan-sitagliptin-phosphate-monohydrate-januvia-emea-000470-pip01-08-m03_en.pdf"},
    {"id":"39501","name":"P/0102/2013: EMA decision of 30 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for ivabradine (hydrochloride) (Procoralan) (EMEA-000628-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203739/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0102-2013-ema-decision-30-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-ivabradine-hydrochloride-procoralan-emea-000628-pip01-09-m04_en.pdf"},
    {"id":"39514","name":"P/0157/2017: EMA decision of 9 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone (furoate) / vilanterol (Relvar Ellipta and associated names), (EMEA-000431-PIP01-08-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-25T02:00:00Z","last_updated_date":"2017-07-25T02:00:00Z","reference_number":"EMA/350306/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2017-ema-decision-9-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-vilanterol-relvar-ellipta-associated-names-emea-000431-pip01-08_en.pdf"},
    {"id":"39553","name":"P/0024/2017: EMA decision of 31 January 2017 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine /\n\ntenofovir alafenamide (Descovy), (EMEA-001577-PIP02-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-20T01:00:00Z","last_updated_date":"2017-03-20T01:00:00Z","reference_number":"EMA/34944/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0024-2017-ema-decision-31-january-2017-acceptance-modification-agreed-paediatric-investigation-plan-emtricitabine-tenofovir-alafenamide-descovy-emea-001577-pip02-14-m01_en.pdf"},
    {"id":"39563","name":"P/0170/2012: EMA decision of 27 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for romiplostim (Nplate) (EMEA-000653-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/490002/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0170-2012-ema-decision-27-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-romiplostim-nplate-emea-000653-pip01-09-m02_en.pdf"},
    {"id":"39600","name":"P/0256/2017: EMA decision of 4 September 2017 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat (Rezolsta), (EMEA-001280-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-10-26T17:00:00Z","last_updated_date":"2017-10-26T17:00:00Z","reference_number":"EMA/498846/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2017-ema-decision-4-september-2017-acceptance-modification-agreed-paediatric-investigation-plan-darunavir-cobicistat-rezolsta-emea-001280-pip01-12-m01_en.pdf"},
    {"id":"39611","name":"P/0181/2014: EMA decision of 17 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir / ledipasvir (EMEA-001411-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/414174/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2014-ema-decision-17-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-sofosbuvir-ledipasvir-emea-001411-pip01-12-m01_en.pdf"},
    {"id":"39636","name":"P/0225/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for decitabine (Dacogen), (EMEA-000555-PIP01-09-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/562590/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2013-ema-decision-23-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-decitabine-dacogen-emea-000555-pip01-09-m04_en.pdf"},
    {"id":"39665","name":"P/0113/2016: EMA decision of 15 April 2016 on the granting of a product specific waiver for finasteride (EMEA-001878-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-06-02T02:00:00Z","last_updated_date":"2016-06-02T02:00:00Z","reference_number":"EMA/203924/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0113-2016-ema-decision-15-april-2016-granting-product-specific-waiver-finasteride-emea-001878-pip01-15_en.pdf"},
    {"id":"39669","name":"P/0106/2014: EMA decision of 5 May 2014 on the acceptance of a modification of an agreed paediatric investigation plan for octadecasodium hexakis(4-{[(1S,3R)-1-([1,1´-biphenyl]-4-ylmethyl)-4-ethoxy-3-methyl-4-oxobutyl]am...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-11T16:00:00Z","last_updated_date":"2014-06-11T16:00:00Z","reference_number":"EMA/169104/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2014-ema-decision-5-may-2014-acceptance-modification-agreed-paediatric-investigation-plan-octadecasodium-hexakis4-1s3r-1-11-biphenyl-4-ylmethyl-4-ethoxy-3-methyl-4-oxobutylam_en.pdf"},
    {"id":"39672","name":"P/0057/2012: EMA decision of 26 March 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lanthanum carbonate hydrate (Fosrenol and associated names), (EMEA-000637-PIP02-10-M02","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-04-20T17:42:00Z","last_updated_date":"2012-04-20T17:42:00Z","reference_number":"EMA/190322/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0057-2012-ema-decision-26-march-2012-acceptance-modification-agreed-paediatric-investigation-plan-lanthanum-carbonate-hydrate-fosrenol-associated-names-emea-000637-pip02-10-m02_en.pdf"},
    {"id":"39681","name":"P/0122/2014: EMA decision of 7 May 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant human alpha-mannosidase (EMEA-001056-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-06-05T02:00:00Z","last_updated_date":"2014-06-05T02:00:00Z","reference_number":"EMA/182175/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2014-ema-decision-7-may-2014-agreement-paediatric-investigation-plan-granting-deferral-recombinant-human-alpha-mannosidase-emea-001056-pip02-12_en.pdf"},
    {"id":"39704","name":"P/0110/2013: EMA decision of 30 April 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for bumetanide (EMEA-001303-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/201276/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0110-2013-ema-decision-30-april-2013-agreement-paediatric-investigation-plan-granting-waiver-bumetanide-emea-001303-pip01-12_en.pdf"},
    {"id":"39716","name":"P/0275/2013: EMA decision of 30 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for rufinamide (Inovelon), (EMEA-000709-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-19T01:00:00Z","last_updated_date":"2013-11-19T01:00:00Z","reference_number":"EMA/592148/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0275-2013-ema-decision-30-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-rufinamide-inovelon-emea-000709-pip01-09-m01_en.pdf"},
    {"id":"39722","name":"P/0220/2014: EMA decision of 3 September 2014 on the acceptance of a modification of an agreed paediatric investigation plan for idelalisib (EMEA-001350-PIP02-13-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-09-29T02:00:00Z","last_updated_date":"2014-09-29T02:00:00Z","reference_number":"EMA/468296/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0220-2014-ema-decision-3-september-2014-acceptance-modification-agreed-paediatric-investigation-plan-idelalisib-emea-001350-pip02-13-m01_en.pdf"},
    {"id":"39735","name":"P/0020/2017: European Medicines Agency decision of 31 January 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for esketamine (hydrochloride) (EME...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-03-17T01:00:00Z","last_updated_date":"2017-03-17T01:00:00Z","reference_number":"EMA/36031/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2017-european-medicines-agency-decision-31-january-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-esketamine-hydrochloride-eme_en.pdf"},
    {"id":"39740","name":"P/0198/2014: EMA decision of 8 August 2014 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (EMEA-000782-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-22T02:00:00Z","last_updated_date":"2014-08-22T02:00:00Z","reference_number":"EMA/391829/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2014-ema-decision-8-august-2014-acceptance-modification-agreed-paediatric-investigation-plan-tralokinumab-emea-000782-pip01-09-m02_en.pdf"},
    {"id":"39751","name":"P/0268/2012: EMA decision of 20 November 2012 on the granting of a product-specific waiver for lopinavir / ritonavir / lamivudine (EMEA-001307-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"EMA/646961/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2012-ema-decision-20-november-2012-granting-product-specific-waiver-lopinavir-ritonavir-lamivudine-emea-001307-pip01-12_en.pdf"},
    {"id":"39767","name":"P/0074/2015: EMA decision of 1 April 2015 on the agreement of a paediatric investigation plan and on the granting of a waiver for tetrabenazine (ADV6979) (EMEA-001404-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-07T02:00:00Z","last_updated_date":"2015-05-07T02:00:00Z","reference_number":"EMA/138220/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2015-ema-decision-1-april-2015-agreement-paediatric-investigation-plan-granting-waiver-tetrabenazine-adv6979-emea-001404-pip01-12_en.pdf"},
    {"id":"39775","name":"P/0190/2012: EMA decision of 24 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for lubiprostone (EMEA-000245-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/546451/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2012-ema-decision-24-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-lubiprostone-emea-000245-pip01-08-m01_en.pdf"},
    {"id":"39800","name":"P/103/2010: European Medicines Agency decision of 11 June 2010 on the agreement of a paediatric investigation plan and on the granting of a waiver for Human Papillomavirus Type 6 L1 protein / Type 11 L1 protein / Type 16...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-07-27T02:00:00Z","last_updated_date":"2010-07-27T02:00:00Z","reference_number":"EMA/343650/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-103-2010-european-medicines-agency-decision-11-june-2010-agreement-paediatric-investigation-plan-granting-waiver-human-papillomavirus-type-6-l1-protein-type-11-l1-protein-type-16_en.pdf"},
    {"id":"39824","name":"P/0042/2018: EMA decision of 16 February 2018 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel)\n\n(EMEA-000567-PIP01-09-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-18T11:41:00Z","last_updated_date":"2018-04-18T11:41:00Z","reference_number":"EMA/75416/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0042-2018-ema-decision-16-february-2018-acceptance-modification-agreed-paediatric-investigation-plan-dasatinib-sprycel-emea-000567-pip01-09-m05_en.pdf"},
    {"id":"39834","name":"P/0174/2016: EMA decision of 30 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for sofosbuvir /\n\nledipasvir (Harvoni), (EMEA-001411-PIP01-12-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/408683/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2016-ema-decision-30-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-sofosbuvir-ledipasvir-harvoni-emea-001411-pip01-12-m03_en.pdf"},
    {"id":"39839","name":"P/0019/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for surotomycin (EMEA-001226-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/779669/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0019-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-surotomycin-emea-001226-pip01-11-m01_en.pdf"},
    {"id":"39853","name":"P/303/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for pollen from betula verrucosa, (EMEA-000865-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-24T01:00:00Z","last_updated_date":"2011-01-24T01:00:00Z","reference_number":"EMA/683400/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-303-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-pollen-betula-verrucosa-emea-000865-pip01-10_en.pdf"},
    {"id":"39864","name":"P/0041/2014: European Medicines Agency decision of 5 March 2014 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for fluocinolone acetonide (EMEA-001494-P...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/43432/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0041-2014-european-medicines-agency-decision-5-march-2014-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-fluocinolone-acetonide-emea-001494-p_en.pdf"},
    {"id":"39869","name":"P/39/2008: European medicines agency decision of 24 June 2008\n\non the application for agreement of a Paediatric Investigation Plan for taranabant (EMEA-000062-PIP01-07) in accordance with Regulation (EC) No 1901/2006 of ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-07-21T02:00:00Z","last_updated_date":"2008-07-21T02:00:00Z","reference_number":"EMEA/313283/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-39-2008-european-medicines-agency-decision-24-june-2008-application-agreement-paediatric-investigation-plan-taranabant-emea-000062-pip01-07-accordance-regulation-ec-no-1901-2006_en.pdf"},
    {"id":"39879","name":"P/250/2011: EMA decision of 25 October 2011 on the acceptance of a modification of an agreed paediatric investigation plan for influenza virus type\n\nA, H1N1 / influenza virus type A, H3N2 / influenza virus type B, yamaga...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-11-30T17:00:00Z","last_updated_date":"2011-11-30T17:00:00Z","reference_number":"EMA/834849/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-250-2011-ema-decision-25-october-2011-acceptance-modification-agreed-paediatric-investigation-plan-influenza-virus-type-h1n1-influenza-virus-type-h3n2-influenza-virus-type-b-yamaga_en.pdf"},
    {"id":"39891","name":"P/0311/2012: EMA decision of 21 December 2012 on the granting and on the refusal of a product-specific waiver for expanded autologous bone-marrow-derived osteoblastic cells (EMEA-001329-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T14:00:00Z","last_updated_date":"2013-02-08T14:00:00Z","reference_number":"EMA/811258/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0311-2012-ema-decision-21-december-2012-granting-refusal-product-specific-waiver-expanded-autologous-bone-marrow-derived-osteoblastic-cells-emea-001329-pip01-12_en.pdf"},
    {"id":"39915","name":"P/166/2011: EMA decision of 6 July 2011 on the granting of a product specific waiver for ciclosporin (EMEA-001007-PIP01-10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-08-09T02:00:00Z","last_updated_date":"2011-08-09T02:00:00Z","reference_number":"EMA/513787/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-166-2011-ema-decision-6-july-2011-granting-product-specific-waiver-ciclosporin-emea-001007-pip01-10_en.pdf"},
    {"id":"39916","name":"P/0229/2016: EMA decision of 1 September 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eculizumab (Soliris), (EMEA-000876-PIP07-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/514471/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2016-ema-decision-1-september-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eculizumab-soliris-emea-000876-pip07-15_en.pdf"},
    {"id":"39957","name":"P/0145/2014: EMA decision of 13 June 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for blinatumomab (EMEA-000574-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-18T02:00:00Z","last_updated_date":"2014-07-18T02:00:00Z","reference_number":"EMA/252151/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2014-ema-decision-13-june-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-blinatumomab-emea-000574-pip02-12_en.pdf"},
    {"id":"39958","name":"P/0082/2017: EMA decision of 5 May 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral for avacopan\n\n(EMEA-002023-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/224404/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0082-2017-ema-decision-5-may-2017-agreement-paediatric-investigation-plan-granting-deferral-avacopan-emea-002023-pip01-16_en.pdf"},
    {"id":"39960","name":"P/192/2010: European Medicines Agency decision of 26 October 2010 on the acceptance of a modification of an agreed paediatric investigation plan for doripenem monohydrate (Doribax), (EMEA-000015-PIP01-07-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-11-24T01:00:00Z","last_updated_date":"2010-11-24T01:00:00Z","reference_number":"EMEA/486009/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-192-2010-european-medicines-agency-decision-26-october-2010-acceptance-modification-agreed-paediatric-investigation-plan-doripenem-monohydrate-doribax-emea-000015-pip01-07-m02_en.pdf"},
    {"id":"39973","name":"P/0021/2013: EMA decision of 15 February 2013 on the acceptance of a modification of an agreed paediatric investigation plan for fluticasone furoate / triphenylacetic acid - 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]etho...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-23T02:00:00Z","last_updated_date":"2013-04-23T02:00:00Z","reference_number":"EMA/87155/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2013-ema-decision-15-february-2013-acceptance-modification-agreed-paediatric-investigation-plan-fluticasone-furoate-triphenylacetic-acid-4-1r-2-6-2-26-dichlorobenzyloxyetho_en.pdf"},
    {"id":"39995","name":"P/0176/2012: EMA decision of 3 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for emtricitabine /\n\nrilpivirine (hydrochloride) / tenofovir (disoproxil fumarate) [FTC/RPV/TDF] (...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/505530/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2012-ema-decision-3-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-emtricitabine-rilpivirine-hydrochloride-tenofovir-disoproxil-fumarate-ftc-rpv-tdf_en.pdf"},
    {"id":"40010","name":"P/0005/2018: EMA decision of 15 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lumacaftor / ivacaftor (Orkambi), (EMEA-001582-PIP01-13-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/7638/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0005-2018-ema-decision-15-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-lumacaftor-ivacaftor-orkambi-emea-001582-pip01-13-m07_en.pdf"},
    {"id":"40014","name":"P/0243/2015: EMA decision of 30 October 2015 on the acceptance of a modification of an agreed paediatric investigation plan for icatibant acetate (Firazyr), (EMEA-000408-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-06T01:00:00Z","last_updated_date":"2016-01-06T01:00:00Z","reference_number":"EMA/624869/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2015-ema-decision-30-october-2015-acceptance-modification-agreed-paediatric-investigation-plan-icatibant-acetate-firazyr-emea-000408-pip01-08-m05_en.pdf"},
    {"id":"40038","name":"P/0182/2015: EMA decision of 7 August 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for influenza virus surface antigens (haemagglutinin and ne...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-24T02:00:00Z","last_updated_date":"2015-09-24T02:00:00Z","reference_number":"EMA/473285/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2015-ema-decision-7-august-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-influenza-virus-surface-antigens-haemagglutinin-ne_en.pdf"},
    {"id":"40064","name":"P/42/2009: European Medicines Agency decision of 23 March 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral and on the granting of a waiver for Maribavir (EMEA-000353-PIP01-08) in...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/159851/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-42-2009-european-medicines-agency-decision-23-march-2009-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-maribavir-emea-000353-pip01-08_en.pdf"},
    {"id":"40068","name":"P/302/2011: EMA decision of 20 December 2011 on the granting of a product specific waiver for esketamine (hydrochloride) (EMEA-000770-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-01-19T12:00:00Z","last_updated_date":"2012-01-19T12:00:00Z","reference_number":"EMA/945464/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-302-2011-ema-decision-20-december-2011-granting-product-specific-waiver-esketamine-hydrochloride-emea-000770-pip02-11_en.pdf"},
    {"id":"40083","name":"P/0302/2012: EMA decision of 20 December 2012 on the acceptance of a modification of an agreed paediatric investigation plan for N-[6-(cis-2,6-\n\ndimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4’-(trifluoromethoxy) [1,1’-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-07T13:30:00Z","last_updated_date":"2013-02-07T13:30:00Z","reference_number":"EMA/810528/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2012-ema-decision-20-december-2012-acceptance-modification-agreed-paediatric-investigation-plan-n-6-cis-26-dimethylmorpholin-4-ylpyridine-3-yl-2-methyl-4-trifluoromethoxy-11_en.pdf"},
    {"id":"40118","name":"P/0074/2017: EMA decision of 17 March 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for lamivudine / dolutegravir (EMEA-001940-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-04-21T02:00:00Z","last_updated_date":"2017-04-21T02:00:00Z","reference_number":"EMA/106209/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2017-ema-decision-17-march-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lamivudine-dolutegravir-emea-001940-pip01-16_en.pdf"},
    {"id":"40121","name":"P/0021/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eluxadoline (EMEA-001579-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/792659/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0021-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eluxadoline-emea-001579-pip01-13_en.pdf"},
    {"id":"40125","name":"P/0060/2018: EMA decision of 16 March 2018 on the acceptance of a modification of an agreed paediatric investigation plan for octocog alfa\n\n(Iblias, Kovaltry) (EMEA-001064-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-07T02:00:00Z","last_updated_date":"2018-06-07T02:00:00Z","reference_number":"EMA/102305/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0060-2018-ema-decision-16-march-2018-acceptance-modification-agreed-paediatric-investigation-plan-octocog-alfa-iblias-kovaltry-emea-001064-pip01-10-m03_en.pdf"},
    {"id":"40156","name":"P/0313/2013: EMA decision of 19 December 2013 on the agreement of a paediatric investigation plan for Heterologous Human Adult Liver-derived Progenitor Cells (HHALPC) (EMEA-001155-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-05T01:00:00Z","last_updated_date":"2014-02-05T01:00:00Z","reference_number":"EMA/712443/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0313-2013-ema-decision-19-december-2013-agreement-paediatric-investigation-plan-heterologous-human-adult-liver-derived-progenitor-cells-hhalpc-emea-001155-pip01-11_en.pdf"},
    {"id":"40158","name":"P/36/2011: EMA decision of 28 January 2011 on the refusal of a product specific waiver for recombinant human granulocyte colony stimulating\n\nfactor / recombinant human albumin fusion protein (EMEA-001042-PIP01-10) in acc...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-24T01:00:00Z","last_updated_date":"2011-02-24T01:00:00Z","reference_number":"EMA/35172/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-36-2011-ema-decision-28-january-2011-refusal-product-specific-waiver-recombinant-human-granulocyte-colony-stimulating-factor-recombinant-human-albumin-fusion-protein-emea-001042-pip01-10-acc_en.pdf"},
    {"id":"40168","name":"P/0006/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for denosumab (Xgeva, Prolia) (EMEA-000145-PIP01-07-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/43926/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-denosumab-xgeva-prolia-emea-000145-pip01-07-m07_en.pdf"},
    {"id":"40196","name":"P/0293/2014: EMA decision of 30 October 2014 on the acceptance of a modification of an agreed paediatric investigation plan for bimatoprost (Lumigan and associated names) (EMEA-000917-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-12-09T01:00:00Z","last_updated_date":"2014-12-09T01:00:00Z","reference_number":"EMA/624333/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0293-2014-ema-decision-30-october-2014-acceptance-modification-agreed-paediatric-investigation-plan-bimatoprost-lumigan-associated-names-emea-000917-pip01-10-m04_en.pdf"},
    {"id":"40207","name":"P/75/2008: European medicines agency decision of 12 September 2008 \n\non the application for agreement of a Paediatric Investigation Plan for pramipexole dihydrochloride monohydrate, (Mirapexin) (EMEA-000080-PIP01-07) in ...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-10-10T02:00:00Z","last_updated_date":"2008-10-10T02:00:00Z","reference_number":"EMEA/466827/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-75-2008-european-medicines-agency-decision-12-september-2008-application-agreement-paediatric-investigation-plan-pramipexole-dihydrochloride-monohydrate-mirapexin-emea-000080-pip01-07_en.pdf"},
    {"id":"40248","name":"P/166/2010: European Medicines Agency decision of 3 September 2010 on the acceptance of a modification of an agreed paediatric investigation plan for cinacalcet hydrochloride (Mimpara), (EMEA-000078-PIP01-07-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/478292/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-166-2010-european-medicines-agency-decision-3-september-2010-acceptance-modification-agreed-paediatric-investigation-plan-cinacalcet-hydrochloride-mimpara-emea-000078-pip01-07-m01_en.pdf"},
    {"id":"40288","name":"P/0024/2012: EMA decision of 27 January 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-02-24T12:00:00Z","last_updated_date":"2012-02-24T12:00:00Z","reference_number":"EMA/986418/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0024-2012-ema-decision-27-january-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-n-3-5-2-amino-4-pyrimidinyl-2-11-dimethylethyl_en.pdf"},
    {"id":"40291","name":"P/0070/2015: EMA decision of 1 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for damoctocog alfa pegol (EMEA-001229-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/147275/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2015-ema-decision-1-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-damoctocog-alfa-pegol-emea-001229-pip01-11-m01_en.pdf"},
    {"id":"40305","name":"P/0204/2012: EMA decision of 3 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for dasatinib (Sprycel) (EMEA-000567-PIP01-09-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-10-17T17:00:00Z","last_updated_date":"2012-10-17T17:00:00Z","reference_number":"EMA/559565/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2012-ema-decision-3-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-dasatinib-sprycel-emea-000567-pip01-09-m03_en.pdf"},
    {"id":"40321","name":"P/0191/2012: EMA decision of 24 August 2012 on the acceptance of a modification of an agreed paediatric investigation plan for pazopanib (Votrient) (EMEA-000601-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-17T02:00:00Z","last_updated_date":"2012-09-17T02:00:00Z","reference_number":"EMA/547279/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2012-ema-decision-24-august-2012-acceptance-modification-agreed-paediatric-investigation-plan-pazopanib-votrient-emea-000601-pip01-09-m01_en.pdf"},
    {"id":"40326","name":"P/0375/2017: EMA decision of 1 December 2017 on the acceptance of a modification of an agreed paediatric investigation plan for eculizumab (Soliris),\n\n(EMEA-000876-PIP03-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/711125/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0375-2017-ema-decision-1-december-2017-acceptance-modification-agreed-paediatric-investigation-plan-eculizumab-soliris-emea-000876-pip03-14-m01_en.pdf"},
    {"id":"40339","name":"P/0106/2015: EMA decision of 13 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for humanised monoclonal antibody IgG2 recognising the interl...","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/284200/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0106-2015-ema-decision-13-may-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-humanised-monoclonal-antibody-igg2-recognising-interl_en.pdf"},
    {"id":"40348","name":"P/0085/2012: EMA decision of 21 May 2012 on the acceptance of a modification of an agreed paediatric investigation plan for on the acceptance of a modification of an agreed paediatric investigation plan for L-Cysteinyl-L...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-06-22T18:00:00Z","last_updated_date":"2012-06-22T18:00:00Z","reference_number":"EMA/273076/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0085-2012-ema-decision-21-may-2012-acceptance-modification-agreed-paediatric-investigation-plan-acceptance-modification-agreed-paediatric-investigation-plan-l-cysteinyl-l_en.pdf"},
    {"id":"40356","name":"P/0298/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for ticagrelor (Brilique), (EMEA-000480-PIP01-08-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-02-02T01:00:00Z","last_updated_date":"2016-02-02T01:00:00Z","reference_number":"EMA/773336/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2015-ema-decision-21-december-2015-acceptance-modification-agreed-paediatric-investigation-plan-ticagrelor-brilique-emea-000480-pip01-08-m08_en.pdf"},
    {"id":"40360","name":"P/0297/2012: EMA decision of 18 December 2012 on the granting of a product-specific waiver for elagolix (EMEA-001323-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-03-11T01:00:00Z","last_updated_date":"2013-03-11T01:00:00Z","reference_number":"EMA/802207/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0297-2012-ema-decision-18-december-2012-granting-product-specific-waiver-elagolix-emea-001323-pip02-12_en.pdf"},
    {"id":"40404","name":"P/0151/2014: EMA decision of 13 June 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral for recombinant human beta-glucuronidase (rhGUS, UX003) (EMEA-001540-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-07-22T02:00:00Z","last_updated_date":"2014-07-22T02:00:00Z","reference_number":"EMA/299615/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2014-ema-decision-13-june-2014-agreement-paediatric-investigation-plan-granting-deferral-recombinant-human-beta-glucuronidase-rhgus-ux003-emea-001540-pip01-13_en.pdf"},
    {"id":"40405","name":"P/0197/2015: EMA decision of 4 September 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for omecamtiv mecarbil (EMEA-001696-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-10-20T02:00:00Z","last_updated_date":"2015-10-20T02:00:00Z","reference_number":"EMA/505437/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2015-ema-decision-4-september-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-omecamtiv-mecarbil-emea-001696-pip01-14_en.pdf"},
    {"id":"40429","name":"P/185/2010: European Medicines Agency decision of 24 September 2010 on the granting of a product specific waiver for afamelanotide (EMEA-000737-PIP01-09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-10-29T02:00:00Z","last_updated_date":"2010-10-29T02:00:00Z","reference_number":"EMA/583062/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-185-2010-european-medicines-agency-decision-24-september-2010-granting-product-specific-waiver-afamelanotide-emea-000737-pip01-09_en.pdf"},
    {"id":"40450","name":"P/1/2011: EMA decision of 3 January 2011 on the acceptance of a modification of an agreed paediatric investigation plan for adalimumab (Humira) (EMEA-000366-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-02-07T01:00:00Z","last_updated_date":"2011-02-07T01:00:00Z","reference_number":"EMA/730065/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-1-2011-ema-decision-3-january-2011-acceptance-modification-agreed-paediatric-investigation-plan-adalimumab-humira-emea-000366-pip01-08-m03_en.pdf"},
    {"id":"40461","name":"P/0075/2012: EMA decision of 25 April 2012 on the acceptance of a modification of an agreed paediatric investigation plan for artemether /\n\nlumefantrine (Riamet), (EMEA-000777-PIP01-09-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-05-24T02:00:00Z","last_updated_date":"2012-05-24T02:00:00Z","reference_number":"EMA/256949/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2012-ema-decision-25-april-2012-acceptance-modification-agreed-paediatric-investigation-plan-artemether-lumefantrine-riamet-emea-000777-pip01-09-m02_en.pdf"},
    {"id":"40463","name":"P/0051/2015: EMA decision of 6 March 2015 on the granting of a product-specific waiver for candesartan / amlodipine (EMEA-001711-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-24T01:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/49322/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0051-2015-ema-decision-6-march-2015-granting-product-specific-waiver-candesartan-amlodipine-emea-001711-pip01-14_en.pdf"},
    {"id":"40492","name":"P/71/2008: European medicines agency decision of 20 August 2008\n\non the application for agreement of a Paediatric Investigation Plan for nicotinic acid, simvastatin and laropiprant (EMEA-000253-PIP01-08), in accordance w...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/431920/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-71-2008-european-medicines-agency-decision-20-august-2008-application-agreement-paediatric-investigation-plan-nicotinic-acid-simvastatin-laropiprant-emea-000253-pip01-08-accordance-w_en.pdf"},
    {"id":"40506","name":"P/0165/2015: EMA decision of 7 August 2015 on the acceptance of a modification of an agreed paediatric investigation plan for tadalafil (Adcirca, Cialis), (EMEA-000452-PIP02-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-09-25T02:00:00Z","last_updated_date":"2015-09-25T02:00:00Z","reference_number":"EMA/473605/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2015-ema-decision-7-august-2015-acceptance-modification-agreed-paediatric-investigation-plan-tadalafil-adcirca-cialis-emea-000452-pip02-10-m03_en.pdf"},
    {"id":"40523","name":"P/0155/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for letermovir (EMEA-001631-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/382965/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-deferral-letermovir-emea-001631-pip01-14_en.pdf"},
    {"id":"40550","name":"P/0180/2017: EMA decision of 3 July 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for live, attenuated, chimeric dengue virus, serotype 1/live,...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-24T02:00:00Z","last_updated_date":"2017-07-24T02:00:00Z","reference_number":"EMA/348043/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2017-ema-decision-3-july-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-live-attenuated-chimeric-dengue-virus-serotype-1-live_en.pdf"},
    {"id":"40573","name":"P/0176/2014: EMA decision of 2 July 2014 on the acceptance of a modification of an agreed paediatric investigation plan for asfotase alfa (EMEA-000987-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-08-05T15:00:00Z","last_updated_date":"2014-08-05T15:00:00Z","reference_number":"EMA/367080/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2014-ema-decision-2-july-2014-acceptance-modification-agreed-paediatric-investigation-plan-asfotase-alfa-emea-000987-pip01-10-m02_en.pdf"},
    {"id":"40578","name":"P/95/2009: European Medicines Agency decision of 19 May 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a deferral for raltegravir (ISENTRESS ) (EMEA-000279-PIP01-08) in accordance with Re...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-07-09T02:00:00Z","last_updated_date":"2009-07-09T02:00:00Z","reference_number":"EMEA/288499/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-95-2009-european-medicines-agency-decision-19-may-2009-agreement-paediatric-investigation-plan-granting-deferral-raltegravir-isentress-emea-000279-pip01-08-accordance-re_en.pdf"},
    {"id":"40579","name":"P/0126/2015: EMA decision of 5 June 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral for vericiguat (EMEA-001636-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-07-03T02:00:00Z","last_updated_date":"2015-07-03T02:00:00Z","reference_number":"EMA/300765/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0126-2015-ema-decision-5-june-2015-agreement-paediatric-investigation-plan-granting-deferral-vericiguat-emea-001636-pip01-14_en.pdf"},
    {"id":"40590","name":"P/0288/2015: EMA decision of 27 November 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]py...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-01-07T01:00:00Z","last_updated_date":"2016-01-07T01:00:00Z","reference_number":"EMA/764433/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2015-ema-decision-27-november-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-3s4r-3-ethyl-4-3h-imidazo12-apyrrolo23-epy_en.pdf"},
    {"id":"40600","name":"P/0171/2012: EMA decision of 27 July 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for apremilast (EMEA-000715-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-23T16:00:00Z","last_updated_date":"2012-08-23T16:00:00Z","reference_number":"EMA/436956/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2012-ema-decision-27-july-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-apremilast-emea-000715-pip02-11_en.pdf"},
    {"id":"40601","name":"P/0237/2013: EMA decision of 24 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for sonidegib, (EMEA-000880-PIP02-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-21T01:00:00Z","last_updated_date":"2013-11-21T01:00:00Z","reference_number":"EMA/565106/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0237-2013-ema-decision-24-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-sonidegib-emea-000880-pip02-11-m02_en.pdf"},
    {"id":"40606","name":"P/0056/2013: EMA decision of 25 March 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral for oritavancin (diphosphate) (EMEA-001270-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-04-30T14:00:00Z","last_updated_date":"2013-04-30T14:00:00Z","reference_number":"EMA/85751/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0056-2013-ema-decision-25-march-2013-agreement-paediatric-investigation-plan-granting-deferral-oritavancin-diphosphate-emea-001270-pip01-12_en.pdf"},
    {"id":"40639","name":"P/96/2010: European Medicines Agency decision of 4 June 2010 on the acceptance of a modification of an agreed paediatric investigation plan for canakinumab (EMEA-000060-PIP01-07-M02) in accordance with Regulation (EC) No...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-01-25T00:00:00Z","last_updated_date":"2010-07-28T01:00:00Z","reference_number":"EMA/335510/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-96-2010-european-medicines-agency-decision-4-june-2010-acceptance-modification-agreed-paediatric-investigation-plan-canakinumab-emea-000060-pip01-07-m02-accordance-regulation-ec-no_en.pdf"},
    {"id":"40679","name":"P/0280/2016: EMA decision of 12 October 2016 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human\n\nnerve growth factor (EMEA-001729-PIP01-14-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-24T01:00:00Z","last_updated_date":"2016-11-24T01:00:00Z","reference_number":"EMA/657489/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0280-2016-ema-decision-12-october-2016-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-nerve-growth-factor-emea-001729-pip01-14-m01_en.pdf"},
    {"id":"40687","name":"P/0084/2014: EMA decision of 4 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for rivaroxaban (Xarelto), (EMEA-000430-PIP01-08-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/113586/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0084-2014-ema-decision-4-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-rivaroxaban-xarelto-emea-000430-pip01-08-m05_en.pdf"},
    {"id":"40693","name":"P/68/2008: European medicines agency decision of 15 August 2008 on the application for product specific waiver for dexamethasone (EMEA-000198 PIP01-08) in accordance with Regulation (EC) No 1901/2006 of the European Parl...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-09-18T02:00:00Z","last_updated_date":"2008-09-18T02:00:00Z","reference_number":"EMEA/423051/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-68-2008-european-medicines-agency-decision-15-august-2008-application-product-specific-waiver-dexamethasone-emea-000198-pip01-08-accordance-regulation-ec-no-1901-2006-european-parl_en.pdf"},
    {"id":"40694","name":"P/317/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of pollen from Phleum prate...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/697308/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-317-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-pollen-phleum-prate_en.pdf"},
    {"id":"40709","name":"P/0201/2016: EMA decision of 28 July 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for eculizumab (Soliris), (EMEA-000876-PIP06-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-09-22T02:00:00Z","last_updated_date":"2016-09-22T02:00:00Z","reference_number":"EMA/472130/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2016-ema-decision-28-july-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-eculizumab-soliris-emea-000876-pip06-15_en.pdf"},
    {"id":"40738","name":"P/0229/2012: EMA decision of 4 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for bitopertin (EMEA-000439-PIP02-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/587320/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2012-ema-decision-4-october-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-bitopertin-emea-000439-pip02-11_en.pdf"},
    {"id":"40749","name":"P/0303/2012: EMA decision of 20 December 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral for dextran, 3-[(2-aminoethyl)thio]propyl 17-carboxy-10,13,16-tris(carboxymethyl)-8-oxo-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-02-08T10:40:00Z","last_updated_date":"2013-02-08T10:40:00Z","reference_number":"EMA/810617/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0303-2012-ema-decision-20-december-2012-agreement-paediatric-investigation-plan-granting-deferral-dextran-3-2-aminoethylthiopropyl-17-carboxy-101316-triscarboxymethyl-8-oxo_en.pdf"},
    {"id":"40783","name":"P/0266/2014: EMA decision of 13 October 2014 on the agreement of a paediatric investigation plan for allantoin (EMEA-001590-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-11-05T01:00:00Z","last_updated_date":"2014-11-05T01:00:00Z","reference_number":"EMA/592743/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2014-ema-decision-13-october-2014-agreement-paediatric-investigation-plan-allantoin-emea-001590-pip01-13_en.pdf"},
    {"id":"40806","name":"P/181/2009: European Medicines Agency decision of 7 September 2009 on the granting of a product specific waiver for paracetamol / opium prepared (EMEA-000513-PIP01-08) in accordance with Regulation (EC) No 1901/2006 of t...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-10-22T02:00:00Z","last_updated_date":"2009-10-22T02:00:00Z","reference_number":"EMEA/523568/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-181-2009-european-medicines-agency-decision-7-september-2009-granting-product-specific-waiver-paracetamol-opium-prepared-emea-000513-pip01-08-accordance-regulation-ec-no-1901-2006-t_en.pdf"},
    {"id":"40816","name":"P/125/2010:  European Medicines Agency decision of 28 July 2010 on the refusal of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for lidocaine/tetracaine (EMEA-000168-PIP...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2010-08-26T02:00:00Z","last_updated_date":"2010-08-26T02:00:00Z","reference_number":"EMA/464924/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-125-2010-european-medicines-agency-decision-28-july-2010-refusal-paediatric-investigation-plan-refusal-deferral-granting-waiver-lidocaine-tetracaine-emea-000168-pip_en.pdf"},
    {"id":"40824","name":"P/0167/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for eltrombopag\n\n(Revolade) (EMEA-000170-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/193031/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-eltrombopag-revolade-emea-000170-pip01-07-m04_en.pdf"},
    {"id":"40825","name":"P/0221/2013: EMA decision of 9 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tolvaptan (Samsca), (EMEA-001231-PIP02-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-10-08T02:00:00Z","last_updated_date":"2013-10-08T02:00:00Z","reference_number":"EMA/493083/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2013-ema-decision-9-september-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tolvaptan-samsca-emea-001231-pip02-13_en.pdf"},
    {"id":"40833","name":"P/184/2011: EMA decision of 4 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for tapentadol (hydrochloride) (Palexia) (EMEA-000494-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-09-15T02:00:00Z","last_updated_date":"2011-09-15T02:00:00Z","reference_number":"EMA/601915/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-184-2011-ema-decision-4-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-tapentadol-hydrochloride-palexia-emea-000494-pip01-08-m03_en.pdf"},
    {"id":"40836","name":"P/53/2009: European Medicines Agency decision of 24 March 2009 on the granting of a product specific waiver for bisoprolol fumarate / acetylsalicylic acid (EMEA-000448-PIP01-08) in accordance with Regulation (EC) No 1901...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-05-18T02:00:00Z","last_updated_date":"2009-05-18T02:00:00Z","reference_number":"EMEA/167312/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-53-2009-european-medicines-agency-decision-24-march-2009-granting-product-specific-waiver-bisoprolol-fumarate-acetylsalicylic-acid-emea-000448-pip01-08-accordance-regulation-ec-no-1901_en.pdf"},
    {"id":"40876","name":"P/0235/2012: EMA decision of 22 October 2012 on the acceptance of a modification of an agreed paediatric investigation plan for bevacizumab (Avastin), (EMEA-000056-PIP03-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-26T01:00:00Z","last_updated_date":"2012-11-26T01:00:00Z","reference_number":"EMA/636944/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2012-ema-decision-22-october-2012-acceptance-modification-agreed-paediatric-investigation-plan-bevacizumab-avastin-emea-000056-pip03-10-m01_en.pdf"},
    {"id":"40899","name":"P/0083/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (EMEA-000069-PIP01-07-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-15T02:00:00Z","last_updated_date":"2015-06-15T02:00:00Z","reference_number":"EMA/281887/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0083-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-emea-000069-pip01-07-m03_en.pdf"},
    {"id":"40925","name":"P/0006/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for telbivudine (Sebivo) (EMEA-000065-PIP01-07-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-19T01:00:00Z","last_updated_date":"2014-02-19T01:00:00Z","reference_number":"EMA/784553/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-telbivudine-sebivo-emea-000065-pip01-07-m04_en.pdf"},
    {"id":"40927","name":"P/0252/2012: EMA decision of 19 October 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for natalizumab (Tysabri) (EMEA-001095-PIP02-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/659209/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2012-ema-decision-19-october-2012-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-natalizumab-tysabri-emea-001095-pip02-12_en.pdf"},
    {"id":"40949","name":"P/0278/2016: EMA decision of 7 October 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for macrogol 3350 / sodium sulfate / sodium chloride / po...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-11-23T01:00:00Z","last_updated_date":"2016-11-23T01:00:00Z","reference_number":"EMA/501874/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0278-2016-ema-decision-7-october-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-macrogol-3350-sodium-sulfate-sodium-chloride-po_en.pdf"},
    {"id":"40958","name":"P/273/2010: EMA decision of 3 December 2010 on the acceptance of a modification of an agreed paediatric investigation plan for catridecacog (EMEA-\n\n000185-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-10T01:00:00Z","last_updated_date":"2011-01-10T01:00:00Z","reference_number":"EMA/764095/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-273-2010-ema-decision-3-december-2010-acceptance-modification-agreed-paediatric-investigation-plan-catridecacog-emea-000185-pip01-08-m03_en.pdf"},
    {"id":"40973","name":"P/0152/2015: EMA decision of 10 July 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for selumetinib (EMEA-001585-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-08-25T02:00:00Z","last_updated_date":"2015-08-25T02:00:00Z","reference_number":"EMA/370542/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2015-ema-decision-10-july-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-selumetinib-emea-001585-pip01-13_en.pdf"},
    {"id":"40981","name":"P/0077/2018: EMA decision of 16 March 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for crizanlizumab (EMEA-002141-PIP01-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/102437/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2018-ema-decision-16-march-2018-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-crizanlizumab-emea-002141-pip01-17_en.pdf"},
    {"id":"41046","name":"P/0292/2016: EMA decision of 4 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for serelaxin (EMEA-001168-PIP01-11-M03)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-19T11:00:00Z","last_updated_date":"2017-01-19T11:00:00Z","reference_number":"EMA/666205/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0292-2016-ema-decision-4-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-serelaxin-emea-001168-pip01-11-m03_en.pdf"},
    {"id":"41096","name":"P/0244/2013: EMA decision of 4 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for edoxaban (tosylate) (EMEA-000788-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/579644/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0244-2013-ema-decision-4-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-edoxaban-tosylate-emea-000788-pip02-11-m01_en.pdf"},
    {"id":"41100","name":"P/0073/2018: EMA decision of 16 March 2018 on the granting of a product-specific waiver for pemafibrate (EMEA-001573-PIP02-17)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-06-19T02:00:00Z","last_updated_date":"2018-06-19T02:00:00Z","reference_number":"EMA/87925/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2018-ema-decision-16-march-2018-granting-product-specific-waiver-pemafibrate-emea-001573-pip02-17_en.pdf"},
    {"id":"41103","name":"P/0138/2012: EMA decision of 20 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for human normal\n\nimmunoglobulin (EMEA-001110-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-22T14:00:00Z","last_updated_date":"2012-08-22T14:00:00Z","reference_number":"EMA/469914/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2012-ema-decision-20-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-emea-001110-pip01-10-m01_en.pdf"},
    {"id":"41108","name":"P/0224/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for belimumab (Benlysta), (EMEA-000520-PIP01-08-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/493080/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2013-ema-decision-23-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-belimumab-benlysta-emea-000520-pip01-08-m03_en.pdf"},
    {"id":"41116","name":"P/23/2008: European medicines agency decision of 23 May 2008 on the application for agreement of a Paediatric Investigation Plan for albumin interferon alfa-2b, EMEA-000017-PIP01-07, in accordance with Regulation (EC) No...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2008-06-17T02:00:00Z","last_updated_date":"2008-06-17T02:00:00Z","reference_number":"EMEA/258718/2008","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-23-2008-european-medicines-agency-decision-23-may-2008-application-agreement-paediatric-investigation-plan-albumin-interferon-alfa-2b-emea-000017-pip01-07-accordance-regulation-ec-no_en.pdf"},
    {"id":"41122","name":"P/0247/2012: EMA decision of 22 October 2012 on the granting of a product-specific waiver for atorvastatin / ramipril / acetyl salicylic acid (EMEA-\n\n001342-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-27T01:00:00Z","last_updated_date":"2012-11-27T01:00:00Z","reference_number":"EMA/587295/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2012-ema-decision-22-october-2012-granting-product-specific-waiver-atorvastatin-ramipril-acetyl-salicylic-acid-emea-001342-pip01-12_en.pdf"},
    {"id":"41150","name":"P/0038/2014: EMA decision of 5 March 2014 on the acceptance of a modification of an agreed paediatric investigation plan for trenonacog alfa (EMEA-000661-PIP01-09-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-04-16T02:00:00Z","last_updated_date":"2014-04-16T02:00:00Z","reference_number":"EMA/57221/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0038-2014-ema-decision-5-march-2014-acceptance-modification-agreed-paediatric-investigation-plan-trenonacog-alfa-emea-000661-pip01-09-m06_en.pdf"},
    {"id":"41161","name":"P/0056/2016: EMA decision of 18 March 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dalbavancin (Xydalba) (EMEA-000016-PIP01-07-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2016-04-25T02:00:00Z","last_updated_date":"2016-04-25T02:00:00Z","reference_number":"EMA/139325/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0056-2016-ema-decision-18-march-2016-acceptance-modification-agreed-paediatric-investigation-plan-dalbavancin-xydalba-emea-000016-pip01-07-m05_en.pdf"},
    {"id":"41167","name":"P/0097/2015: EMA decision of 8 May 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human recombinant interleukin-2 (EMEA-001556-PIP01-13)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2015-06-16T02:00:00Z","last_updated_date":"2015-06-16T02:00:00Z","reference_number":"EMA/281879/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0097-2015-ema-decision-8-may-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-recombinant-interleukin-2-emea-001556-pip01-13_en.pdf"},
    {"id":"41175","name":"P/0123/2012: EMA decision of 4 July 2012 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (EMEA-000467-PIP01-08-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-08-06T18:00:00Z","last_updated_date":"2012-08-06T18:00:00Z","reference_number":"EMA/413047/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2012-ema-decision-4-july-2012-acceptance-modification-agreed-paediatric-investigation-plan-perampanel-emea-000467-pip01-08-m02_en.pdf"},
    {"id":"41183","name":"P/0200/2012: EMA decision of 24 August 2012 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for human fibrinogen (EMEA-001208-PIP01-11)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-09-18T14:00:00Z","last_updated_date":"2012-09-18T14:00:00Z","reference_number":"EMA/478268/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0200-2012-ema-decision-24-august-2012-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-human-fibrinogen-emea-001208-pip01-11_en.pdf"},
    {"id":"41193","name":"P/0267/2012: EMA decision of 20 November 2012 on the agreement of a paediatric investigation plan and on the granting of a waiver for travoprost (Travatan), (EMEA-001271-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-11T01:00:00Z","last_updated_date":"2013-01-11T01:00:00Z","reference_number":"EMA/722248/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2012-ema-decision-20-november-2012-agreement-paediatric-investigation-plan-granting-waiver-travoprost-travatan-emea-001271-pip01-12_en.pdf"},
    {"id":"41211","name":"P/0037/2015: EMA decision of 6 March 2015 on the acceptance of a modification of an agreed paediatric investigation plan for lixisenatide (Lyxumia) (EMEA-000916-PIP01-10-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-25T01:00:00Z","last_updated_date":"2015-03-25T01:00:00Z","reference_number":"EMA/80301/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0037-2015-ema-decision-6-march-2015-acceptance-modification-agreed-paediatric-investigation-plan-lixisenatide-lyxumia-emea-000916-pip01-10-m04_en.pdf"},
    {"id":"41223","name":"P/0119/2013: EMA decision of 3 May 2013 on the agreement of a paediatric investigation plan for autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-21T14:10:00Z","last_updated_date":"2013-06-21T14:10:00Z","reference_number":"EMA/202333/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0119-2013-ema-decision-3-may-2013-agreement-paediatric-investigation-plan-autologous-haematopoietic-stem-cells-transduced-lentiviral-vector-lenti-d-encoding-human-atp-binding-cassette-sub_en.pdf"},
    {"id":"41257","name":"P/01/2009: European Medicines Agency decision of 15 January 2009 on the granting of a product specific waiver for aliskiren hemifumarate, valsartan (EMEA-000192-PIP01-08) in accordance with Regulation (EC) No 1901/2006 o...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2009-03-06T01:00:00Z","last_updated_date":"2009-03-06T01:00:00Z","reference_number":"EMEA/6774/2009","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-01-2009-european-medicines-agency-decision-15-january-2009-granting-product-specific-waiver-aliskiren-hemifumarate-valsartan-emea-000192-pip01-08-accordance-regulation-ec-no-1901-2006-o_en.pdf"},
    {"id":"41275","name":"P/324/2010: EMA decision of 22 December 2010 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for modified allergen extract of grass and rye pollen (EM...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-01-25T01:00:00Z","last_updated_date":"2011-01-25T01:00:00Z","reference_number":"EMA/769512/2010","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-324-2010-ema-decision-22-december-2010-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-modified-allergen-extract-grass-rye-pollen-em_en.pdf"},
    {"id":"41291","name":"P/0160/2016: EMA decision of 15 June 2016 on the acceptance of a modification of an agreed paediatric investigation plan for ferric citrate\n\n(coordination complex) (EMEA-001213-PIP02-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-08-26T02:00:00Z","last_updated_date":"2016-08-26T02:00:00Z","reference_number":"EMA/380513/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2016-ema-decision-15-june-2016-acceptance-modification-agreed-paediatric-investigation-plan-ferric-citrate-coordination-complex-emea-001213-pip02-12-m02_en.pdf"},
    {"id":"41296","name":"P/0123/2017: EMA decision of 5 May 2017 on the acceptance of a modification of an agreed paediatric investigation plan for dopamine\n\n(EMEA-001105-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/253549/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2017-ema-decision-5-may-2017-acceptance-modification-agreed-paediatric-investigation-plan-dopamine-emea-001105-pip01-10-m03_en.pdf"},
    {"id":"41313","name":"P/0007/2018: EMA decision of 30 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for burosumab (EMEA-001659-PIP01-15-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-04-19T02:00:00Z","last_updated_date":"2018-04-19T02:00:00Z","reference_number":"EMA/28046/2018","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0007-2018-ema-decision-30-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-burosumab-emea-001659-pip01-15-m03_en.pdf"},
    {"id":"41352","name":"P/0024/2015: EMA decision of 30 January 2015 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for grazoprevir / elbasvir (EMEA-001604-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/779785/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0024-2015-ema-decision-30-january-2015-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-grazoprevir-elbasvir-emea-001604-pip01-13_en.pdf"},
    {"id":"41368","name":"P/117/2011: EMA decision of 20 May 2011 on the acceptance of a modification of an agreed paediatric investigation plan for aztreonam (Cayston)\n\n(EMEA-000827-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-06-07T02:00:00Z","last_updated_date":"2011-06-07T02:00:00Z","reference_number":"EMA/370084/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-117-2011-ema-decision-20-may-2011-acceptance-modification-agreed-paediatric-investigation-plan-aztreonam-cayston-emea-000827-pip01-09-m01_en.pdf"},
    {"id":"41377","name":"P/0205/2012: EMA decision of 7 September 2012 on the acceptance of a modification of an agreed paediatric investigation plan for etravirine\n\n(Intelence), (EMEA-000222-PIP01-08-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2012-11-23T01:00:00Z","last_updated_date":"2012-12-11T18:00:02Z","reference_number":"EMA/506687/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2012-ema-decision-7-september-2012-acceptance-modification-agreed-paediatric-investigation-plan-etravirine-intelence-emea-000222-pip01-08-m06_en.pdf"},
    {"id":"41413","name":"P/0090/2014: EMA decision of 4 April 2014 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for atazanavir / cobicistat (EMEA-001465-PIP01-13)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2014-05-13T02:00:00Z","reference_number":"EMA/182559/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0090-2014-ema-decision-4-april-2014-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-atazanavir-cobicistat-emea-001465-pip01-13_en.pdf"},
    {"id":"41419","name":"P/196/2011: EMA decision of 26 August 2011 on the acceptance of a modification of an agreed paediatric investigation plan for bilastine (Bilaxten\n\nand associated names), (EMEA-000347-PIP01-08-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2011-10-03T02:00:00Z","last_updated_date":"2011-10-03T02:00:00Z","reference_number":"EMA/669801/2011","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-196-2011-ema-decision-26-august-2011-acceptance-modification-agreed-paediatric-investigation-plan-bilastine-bilaxten-associated-names-emea-000347-pip01-08-m01_en.pdf"},
    {"id":"41436","name":"P/0094/2013: EMA decision of 29 April 2013 on the acceptance of a modification of an agreed paediatric investigation plan for rdESAT-6 / rCFP-10 (EMEA-001156-PIP01-11-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/188023/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0094-2013-ema-decision-29-april-2013-acceptance-modification-agreed-paediatric-investigation-plan-rdesat-6-rcfp-10-emea-001156-pip01-11-m02_en.pdf"},
    {"id":"41439","name":"P/0269/2012: EMA decision of 20 November 2012 on the granting of a product-specific waiver for perindopril / indapamide / amlodipine (EMEA-001337-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-01-04T01:00:00Z","last_updated_date":"2013-01-04T01:00:00Z","reference_number":"EMA/646976/2012","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2012-ema-decision-20-november-2012-granting-product-specific-waiver-perindopril-indapamide-amlodipine-emea-001337-pip01-12_en.pdf"},
    {"id":"41446","name":"P/0109/2013: EMA decision of 30 April 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for epratuzumab (EMEA-001295-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-05-31T02:00:00Z","last_updated_date":"2013-05-31T02:00:00Z","reference_number":"EMA/203508/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0109-2013-ema-decision-30-april-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-epratuzumab-emea-001295-pip01-12_en.pdf"},
    {"id":"41470","name":"P/0258/2013: EMA decision of 29 October 2013 on the acceptance of a modification of an agreed paediatric investigation plan for lebrikizumab (EMEA-001053-PIP01-10-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-18T01:00:00Z","last_updated_date":"2013-11-18T01:00:00Z","reference_number":"EMA/598095/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0258-2013-ema-decision-29-october-2013-acceptance-modification-agreed-paediatric-investigation-plan-lebrikizumab-emea-001053-pip01-10-m02_en.pdf"},
    {"id":"41475","name":"P/0124/2017: EMA decision of 5 May 2017 on the granting of a product-specific waiver for nintedanib (Vargatef, Ofev), (EMEA-001006-PIP03-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-03T02:00:00Z","last_updated_date":"2017-07-03T02:00:00Z","reference_number":"EMA/260237/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0124-2017-ema-decision-5-may-2017-granting-product-specific-waiver-nintedanib-vargatef-ofev-emea-001006-pip03-16_en.pdf"},
    {"id":"41487","name":"P/0036/2016: EMA decision of 5 February 2016 on the granting of a product specific waiver for processed nerve allograft (human) (EMEA-001807-PIP02-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-04-22T02:00:00Z","last_updated_date":"2016-04-22T02:00:00Z","reference_number":"EMA/860243/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2016-ema-decision-5-february-2016-granting-product-specific-waiver-processed-nerve-allograft-human-emea-001807-pip02-15_en.pdf"},
    {"id":"41509","name":"P/0050/2015: EMA decision of 6 March 2015 on the granting of a product-specific waiver for perindopril / amlodipine (EMEA-001702-PIP01-14)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-24T01:00:00Z","last_updated_date":"2015-03-24T01:00:00Z","reference_number":"EMA/65321/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0050-2015-ema-decision-6-march-2015-granting-product-specific-waiver-perindopril-amlodipine-emea-001702-pip01-14_en.pdf"},
    {"id":"41515","name":"P/0314/2016: EMA decision of 25 November 2016 on the acceptance of a modification of an agreed paediatric investigation plan for metreleptin\n\n (EMEA-001701-PIP01-14-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2017-01-20T16:17:00Z","last_updated_date":"2017-01-20T16:17:00Z","reference_number":"EMA/757463/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0314-2016-ema-decision-25-november-2016-acceptance-modification-agreed-paediatric-investigation-plan-metreleptin-emea-001701-pip01-14-m01_en.pdf"},
    {"id":"41524","name":"P/0073/2014: EMA decision of 2 April 2014 on the acceptance of a modification of an agreed paediatric investigation plan for golimumab (Simponi) (EMEA-000265-PIP02-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-05-14T02:00:00Z","last_updated_date":"2014-05-14T02:00:00Z","reference_number":"EMA/103499/2014","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0073-2014-ema-decision-2-april-2014-acceptance-modification-agreed-paediatric-investigation-plan-golimumab-simponi-emea-000265-pip02-11-m01_en.pdf"},
    {"id":"41527","name":"P/0366/2016: EMA decision of 21 December 2016 on the granting of a product specific waiver for ibuprofen (EMEA-002017-PIP01-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-01-30T01:00:00Z","last_updated_date":"2017-01-30T01:00:00Z","reference_number":"EMA/757985/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0366-2016-ema-decision-21-december-2016-granting-product-specific-waiver-ibuprofen-emea-002017-pip01-16_en.pdf"},
    {"id":"41554","name":"P/0377/2017: EMA decision of 1 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for omega-3-carboxylic acids (EMEA-001865-PIP02-16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2018-03-05T01:00:00Z","last_updated_date":"2018-03-05T01:00:00Z","reference_number":"EMA/704196/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0377-2017-ema-decision-1-december-2017-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-omega-3-carboxylic-acids-emea-001865-pip02-16_en.pdf"},
    {"id":"41564","name":"P/0010/2015: EMA decision of 30 January 2015 on the acceptance of a modification of an agreed paediatric investigation plan for conestat alfa (Ruconest) (EMEA-000367-PIP01-08-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-03-05T01:00:00Z","last_updated_date":"2015-03-05T01:00:00Z","reference_number":"EMA/43928/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2015-ema-decision-30-january-2015-acceptance-modification-agreed-paediatric-investigation-plan-conestat-alfa-ruconest-emea-000367-pip01-08-m04_en.pdf"},
    {"id":"41594","name":"P/0139/2017: EMA decision of 7 June 2017 on the acceptance of a modification of an agreed paediatric investigation plan for olaratumab (Lartruvo), (EMEA-001760-PIP01-15-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2017-07-26T02:00:00Z","last_updated_date":"2017-07-26T02:00:00Z","reference_number":"EMA/316519/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2017-ema-decision-7-june-2017-acceptance-modification-agreed-paediatric-investigation-plan-olaratumab-lartruvo-emea-001760-pip01-15-m02_en.pdf"},
    {"id":"41605","name":"P/0020/2014: European Medicines Agency decision of 22 January 2014 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (EMEA-001214-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2014-02-21T01:00:00Z","last_updated_date":"2014-02-21T01:00:00Z","reference_number":"EMA/738870/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0020-2014-european-medicines-agency-decision-22-january-2014-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-emea-001214-pip01-11-m01_en.pdf"},
    {"id":"41624","name":"P/0228/2013: EMA decision of 23 September 2013 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iron as iron maltol (iron(III)-maltol complex), (EM...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/493084/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0228-2013-ema-decision-23-september-2013-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-iron-iron-maltol-ironiii-maltol-complex-em_en.pdf"},
    {"id":"41670","name":"P/0066/2015: EMA decision of 1 April 2015 on the refusal of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana) (EMEA-001030-PIP01-10-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2015-05-06T02:00:00Z","last_updated_date":"2015-05-06T02:00:00Z","reference_number":"EMA/108910/2015","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0066-2015-ema-decision-1-april-2015-refusal-modification-agreed-paediatric-investigation-plan-canagliflozin-invokana-emea-001030-pip01-10-m03_en.pdf"},
    {"id":"41699","name":"P/0147/2013: EMA decision of 3 July 2013 on the agreement of a paediatric investigation plan and on the granting of a waiver for metformin (hydrochloride) (EMEA-001352-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-08-13T17:30:00Z","last_updated_date":"2013-08-13T17:30:00Z","reference_number":"EMA/306201/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2013-ema-decision-3-july-2013-agreement-paediatric-investigation-plan-granting-waiver-metformin-hydrochloride-emea-001352-pip01-12_en.pdf"},
    {"id":"41748","name":"P/0237/2016: EMA decision of 9 September 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the\n\ngranting of a waiver for elafibranor (EMEA-001857-PIP01-15)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2016-10-27T02:00:00Z","last_updated_date":"2016-10-27T02:00:00Z","reference_number":"EMA/580025/2016","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0237-2016-ema-decision-9-september-2016-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-elafibranor-emea-001857-pip01-15_en.pdf"},
    {"id":"41786","name":"P/0001/2018: EMA decision of 8 January 2018 on the acceptance of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat)\n\n(EMEA-000402-PIP02-11-M05)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2018-04-17T15:28:00Z","last_updated_date":"2018-04-17T15:28:00Z","reference_number":"EMA/850455/2017","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0001-2018-ema-decision-8-january-2018-acceptance-modification-agreed-paediatric-investigation-plan-lacosamide-vimpat-emea-000402-pip02-11-m05_en.pdf"},
    {"id":"41791","name":"P/0227/2013: EMA decision of 23 September 2013 on the acceptance of a modification of an agreed paediatric investigation plan for odanacatib, (EMEA-001123-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-11-15T01:00:00Z","last_updated_date":"2013-11-15T01:00:00Z","reference_number":"EMA/562204/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2013-ema-decision-23-september-2013-acceptance-modification-agreed-paediatric-investigation-plan-odanacatib-emea-001123-pip01-11-m01_en.pdf"},
    {"id":"41794","name":"P/0128/2013: EMA decision of 28 May 2013 on the granting of a product-specific waiver for menotrophin (EMEA-001403-PIP01-12)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2013-06-24T13:30:00Z","last_updated_date":"2013-06-24T13:30:00Z","reference_number":"EMA/246008/2013","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0128-2013-ema-decision-28-may-2013-granting-product-specific-waiver-menotrophin-emea-001403-pip01-12_en.pdf"},
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    {"id":"66804","name":"P/0478/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (Mounjaro), (EMEA-002360-PIP02-22-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T17:04:43Z","last_updated_date":"2025-02-14T17:04:43Z","reference_number":"EMA/504548/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0478-2023-ema-decision-1-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-tirzepatide-mounjaro-emea-002360-pip02-22-m02_en.pdf"},
    {"id":"66800","name":"P/0493/2023 : EMA decision of 1 Dec 2023 on the acceptance of a modification of an agreed PIP for indacaterol (acetate) / glycopyrronium (bromide) / mometasone (furoate), (Enerzair Breezhaler, Zimbus Breezhaler), (EMEA-001812-PIP01-15-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T16:22:48Z","last_updated_date":"2025-02-14T16:22:48Z","reference_number":"EMA/530330/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0493-2023-ema-decision-1-dec-2023-acceptance-modification-agreed-pip-indacaterol-acetate-glycopyrronium-bromide-mometasone-furoate-enerzair-breezhaler-zimbus-breezhaler-emea-001812-pip01-15-m02_en.pdf"},
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    {"id":"66803","name":"P/0498/2023 : EMA decision of 1 December 2023 on the granting of a product specific waiver for gotistobart, (EMEA-003467-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-14T16:25:08Z","last_updated_date":"2025-02-14T16:25:08Z","reference_number":"EMA/517080/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0498-2023-ema-decision-1-december-2023-granting-product-specific-waiver-gotistobart-emea-003467-pip01-23_en.pdf"},
    {"id":"66798","name":"P/0492/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for risankizumab (Skyrizi), (EMEA-001776-PIP02-17-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T16:21:07Z","last_updated_date":"2025-02-14T16:21:07Z","reference_number":"EMA/530125/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0492-2023-ema-decision-1-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-risankizumab-skyrizi-emea-001776-pip02-17-m02_en.pdf"},
    {"id":"66811","name":"P/0522/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for cendakimab (EMEA- 002640-PIP01-19-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T17:49:38Z","last_updated_date":"2025-02-14T17:49:38Z","reference_number":"EMA/553394/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0522-2023-ema-decision-29-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-cendakimab-emea-002640-pip01-19-m01_en.pdf"},
    {"id":"66701","name":"Environmental statement 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-02-17T14:00:00Z","last_updated_date":"2025-02-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/environmental-statement-2023_en.pdf"},
    {"id":"66700","name":"EMAS - certificate of registration","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-02-17T14:00:00Z","last_updated_date":"2025-02-17T14:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/emas-certificate-registration_en.pdf","translations":{"nl":"https://www.ema.europa.eu/nl/documents/other/emas-certificate-registration_nl.pdf"}},
    {"id":"66826","name":"P/0523/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for fully human IgG1 RB- 1 YTE anti-RSV F monoclonal antibody (MK-1654) (EMEA-002755-PIP01-19-M02)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-17T14:18:44Z","last_updated_date":"2025-02-17T14:18:44Z","reference_number":"EMA/553405/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0523-2023-ema-decision-29-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-fully-human-igg1-rb-1-yte-anti-rsv-f-monoclonal-antibody-mk-1654-emea-002755-pip01-19-m02_en.pdf"},
    {"id":"66828","name":"P/0510/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate......(EMEA-003155-PIP01-21-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-17T15:46:19Z","last_updated_date":"2025-02-17T15:46:19Z","reference_number":"EMA/554379/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0510-2023-ema-decision-29-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-pneumococcal-polysaccharide-serotype-3-diphtheria-crm197-conjugateemea-003155-pip01-21-m01_en.pdf"},
    {"id":"66829","name":"P/0512/2023 : EMA decision of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for interleukin-23 receptor antagonist peptide (EMEA-003301-PIP01-22-M01)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-02-17T15:53:56Z","last_updated_date":"2025-02-17T15:53:56Z","reference_number":"EMA/554411/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0512-2023-ema-decision-29-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-interleukin-23-receptor-antagonist-peptide-emea-003301-pip01-22-m01_en.pdf"},
    {"id":"66309","name":"Minutes - HMA-EMA joint Big Data Steering Group teleconference - 11 December 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-01-14T14:44:16Z","last_updated_date":"2025-02-17T17:04:00Z","reference_number":"EMA/475371/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-hma-ema-joint-big-data-steering-group-teleconference-11-december-2024_en.pdf"},
    {"id":"66831","name":"Hearing the Association of the European Self-Medication Industry (AESGP) during the September 2024 Working Party meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-02-17T17:44:37Z","last_updated_date":"2025-02-17T17:44:37Z","reference_number":"EMA/HMPC/448628/2024","document_url":"https://www.ema.europa.eu/en/documents/other/hearing-association-european-self-medication-industry-aesgp-during-september-2024-working-party-meeting_en.pdf"},
    {"id":"66835","name":"Template for a European Union herbal monograph","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T18:01:22Z","last_updated_date":"2025-02-17T18:01:22Z","reference_number":"EMA/HMPC/107436/2005 Rev. 8","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-european-union-herbal-monograph_en.pdf-1"},
    {"id":"66836","name":"Template for a European Union herbal monograph","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T18:02:32Z","last_updated_date":"2025-02-17T18:02:32Z","reference_number":"EMA/HMPC/107436/2005 Rev. 8 ","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-european-union-herbal-monograph_en.docx"},
    {"id":"66833","name":"Template for Assessment report for the development of European Union herbal monographs and European Union list entries","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T17:54:30Z","last_updated_date":"2025-02-17T17:54:30Z","reference_number":"EMA/HMPC/418902/2005 Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-assessment-report-development-european-union-herbal-monographs-european-union-list-entries_en.pdf"},
    {"id":"66834","name":"Template for Assessment report for the development of European Union herbal monographs and European Union list entries","type":"template-form","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T17:56:10Z","last_updated_date":"2025-02-17T17:56:10Z","reference_number":"EMA/HMPC/418902/2005 Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/template-form/template-assessment-report-development-european-union-herbal-monographs-european-union-list-entries_en.docx"},
    {"id":"66553","name":"Agenda - ACT EU workshop on ICH E6 (R3)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-01-31T11:19:05Z","last_updated_date":"2025-02-18T09:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-act-eu-workshop-ich-e6-r3_en.pdf"},
    {"id":"66838","name":"Programme - EMA's Open Door Day ","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T09:28:57Z","last_updated_date":"2025-02-18T09:28:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-emas-open-door-day_en.pdf"},
    {"id":"50078","name":"FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014 - CTIS Training Programme - Module 01","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-02-09T11:31:00Z","last_updated_date":"2025-02-18T11:45:00Z","reference_number":"Version 1.3 – February 2025","document_url":"https://www.ema.europa.eu/en/documents/other/faqs-introduction-clinical-trials-regulation-eu-no-536-2014-ctis-training-programme-module-01_en.pdf"},
    {"id":"66848","name":"Presentation - Introduction to EMANS to 2028 (Rui Santos Ivo and Michael Lenihan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:27:59Z","last_updated_date":"2025-02-18T14:27:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-emans-2028-rui-santos-ivo-michael-lenihan_en.pdf"},
    {"id":"66849","name":"Presentation - Accessibility (M. Berntgen) - Theme 1","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:34:05Z","last_updated_date":"2025-02-18T14:34:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accessibility-m-berntgen-theme-1_en.pdf"},
    {"id":"66850","name":"Presentation - Leveraging data, digitalisation and artificial intelligence (P. Arlett) - Theme 2","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:35:31Z","last_updated_date":"2025-02-18T14:35:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-leveraging-data-digitalisation-artificial-intelligence-p-arlett-theme-2_en.pdf"},
    {"id":"66851","name":"Presentation - Regulatory science, innovation and competitiveness (Y. Nuevo) - Theme 3","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:37:10Z","last_updated_date":"2025-02-18T14:37:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-science-innovation-competitiveness-y-nuevo-theme-3_en.pdf"},
    {"id":"66852","name":"Presentation - Antimicrobial resistance and other health threats (T. Haberer) - Theme 4","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:39:34Z","last_updated_date":"2025-02-18T14:39:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antimicrobial-resistance-other-health-threats-t-haberer-theme-4_en.pdf"},
    {"id":"66853","name":"Presentation - Availability and supply (M. Dias) - Theme 5","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:40:31Z","last_updated_date":"2025-02-18T14:40:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-availability-supply-m-dias-theme-5_en.pdf"},
    {"id":"66854","name":"Presentation - Sustainability of the European medicines agencies network (S. Kristjansson) - Theme 6","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-18T14:41:40Z","last_updated_date":"2025-02-18T14:41:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sustainability-european-medicines-agencies-network-s-kristjansson-theme-6_en.pdf"},
    {"id":"3601","name":"Mandate of the European Innovation Network","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-03-15T16:00:00Z","last_updated_date":"2025-02-19T15:25:00Z","reference_number":"EMA/402461/2023","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-european-innovation-network_en.pdf"},
    {"id":"66759","name":"Simultaneous National Scientific Advice (SNSA) - Continuation and further development during 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-02-13T16:48:20Z","last_updated_date":"2025-02-19T10:43:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/simultaneous-national-scientific-advice-snsa-continuation-further-development-during-2025_en.pdf"},
    {"id":"66870","name":"List of contacts for procedure ","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-02-19T11:28:08Z","last_updated_date":"2025-02-19T11:28:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/list-contacts-procedure_en.docx"},
    {"id":"66871","name":"CAT quarterly highlights and approved ATMPs - February 2025","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2025-02-19T11:28:15Z","last_updated_date":"2025-02-19T11:28:15Z","reference_number":"EMA/CAT/52354/2025","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-february-2025_en.pdf"},
    {"id":"66881","name":"P/0502/2023: EMA decision of 1 December 2023 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a waiver for mirabegron (Betmiga), (EMEA-000597-PIP02-10-M10)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T16:57:02Z","last_updated_date":"2025-02-19T16:57:02Z","reference_number":"EMA/528354/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0502-2023-ema-decision-1-december-2023-refusal-modification-agreed-paediatric-investigation-plan-granting-waiver-mirabegron-betmiga-emea-000597-pip02-10-m10_en.pdf"},
    {"id":"66882","name":"P/0503/2023: EMA decision of of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for iron as ferric maltol (Feraccru), (EMEA-001195-PIP01-11-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T17:03:19Z","last_updated_date":"2025-02-19T17:03:19Z","reference_number":"EMA/528355/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0503-2023-ema-decision-29-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-iron-ferric-maltol-feraccru-emea-001195-pip01-11-m07_en.pdf"},
    {"id":"66883","name":"P/0508/2023: EMA decision of of 29 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for respiratory syncytial virus (RSV) PreF3 recombinant fusion protein/AS01 (RSVPreF3 OA) (EMEA-002904-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T17:24:44Z","last_updated_date":"2025-02-19T17:24:44Z","reference_number":"EMA/554228/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0508-2023-ema-decision-29-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-respiratory-syncytial-virus-rsv-pref3-recombinant-fusion-protein-as01-rsvpref3-oa-emea-002904_en.pdf"},
    {"id":"66884","name":"P/0500/2023: EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for treprostinil (sodium) (Trisuva and associated names), (EMEA-003182-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T17:34:54Z","last_updated_date":"2025-02-19T17:34:54Z","reference_number":"EMA/515863/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0500-2023-ema-decision-1-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-treprostinil-sodium-trisuva-associated-names-emea-003182-pip01-22-m01_en.pdf"},
    {"id":"66885","name":"P/0504/2023: EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral for AstraZeneca Anti-SARS-CoV-2 monoclonal antibody (AZD3152), (EMEA-003350-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T17:46:42Z","last_updated_date":"2025-02-19T17:46:42Z","reference_number":"EMA/528356/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0504-2023-ema-decision-29-december-2023-agreement-paediatric-investigation-plan-granting-deferral-astrazeneca-anti-sars-cov-2-monoclonal-antibody-azd3152-emea-003350-pip01-23_en.pdf"},
    {"id":"66886","name":"P/0505/2023: EMA decision of 29 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and of a waiver for broadly neutralizing anti-HIV human monoclonal antibody (VH3810109)(EMEA-003392-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T17:57:55Z","last_updated_date":"2025-02-19T17:57:55Z","reference_number":"EMA/528359/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0505-2023-ema-decision-29-december-2023-agreement-paediatric-investigation-plan-granting-deferral-waiver-broadly-neutralizing-anti-hiv-human-monoclonal-antibody-vh3810109emea-003392-pip01-23_en.pdf"},
    {"id":"66887","name":"P/0506/2023: EMA decision of of 29 December 2023 on the granting of a product specific waiver for elinzanetant (EMEA-003500-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-19T18:08:40Z","last_updated_date":"2025-02-19T18:08:40Z","reference_number":"EMA/528360/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0506-2023-ema-decision-29-december-2023-granting-product-specific-waiver-elinzanetant-emea-003500-pip01-23_en.pdf"},
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    {"id":"64783","name":"Consolidated 3-year rolling work plan for the Oncology Working Party : January 2025 - December 2027","type":"work-programme","status":"unknown","consultation_date":"","first_published_date":"2024-09-10T16:38:46Z","last_updated_date":"2025-02-21T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/work-programme/consolidated-3-year-rolling-work-plan-oncology-working-party-january-2025-december-2027_en.pdf"},
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    {"id":"66940","name":"Final public statement on Tribulus terrestris L., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2025-02-25T12:11:00Z","last_updated_date":"2025-02-25T12:11:00Z","reference_number":"EMA/HMPC/308436/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-public-statement-tribulus-terrestris-l-herba_en.pdf"},
    {"id":"66941","name":"Final assessment report on Tribulus terrestris L., herba","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2025-02-25T12:12:09Z","last_updated_date":"2025-02-25T12:12:09Z","reference_number":"EMA/HMPC/886105/2022","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-tribulus-terrestris-l-herba_en.pdf"},
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    {"id":"66973","name":"CTIS newsflash - 25 February 2025","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2025-02-25T16:09:05Z","last_updated_date":"2025-02-25T16:09:05Z","reference_number":"EMA/36861/2025","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-25-february-2025_en.pdf"},
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    {"id":"12583","name":"Opinion of the HMPC on a European Union herbal monograph on Hieracium pilosella L., herba cum radice - Superseded","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2015-06-17T13:25:00Z","last_updated_date":"2025-02-26T13:25:00Z","reference_number":"EMA/HMPC/165127/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-hieracium-pilosella-l-herba-cum-radice-superseded_en.pdf"},
    {"id":"12661","name":"Final assessment report on Hieracium pilosella L., herba cum radice - Superseded","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2015-06-17T13:25:00Z","last_updated_date":"2025-02-26T13:25:00Z","reference_number":"EMA/HMPC/680373/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-hieracium-pilosella-l-herba-cum-radice-superseded_en.pdf"},
    {"id":"35501","name":"Final list of references supporting the assessment of Hieracium pilosella L., herba cum radice - Superseded","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2015-06-17T13:25:00Z","last_updated_date":"2025-02-26T13:25:00Z","reference_number":"EMA/HMPC/35510/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-hieracium-pilosella-l-herba-cum-radice-superseded_en.pdf"},
    {"id":"19841","name":"Final European Union herbal monograph on Hieracium pilosella L., herba cum radice - Superseded","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2015-06-17T13:25:00Z","last_updated_date":"2025-02-26T13:25:00Z","reference_number":"EMA/HMPC/680374/2013","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-hieracium-pilosella-l-herba-cum-radice-superseded_en.pdf"},
    {"id":"66977","name":"Final assessment report on Pilosella officinarum Vall. (syn Hieracium pilosella L.), herba cum radice - Revision 1","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2025-02-26T09:37:50Z","last_updated_date":"2025-02-26T09:37:50Z","reference_number":"EMA/HMPC/493454/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-pilosella-officinarum-vall-syn-hieracium-pilosella-l-herba-cum-radice-revision-1_en.pdf"},
    {"id":"66978","name":"Final list of references supporting the assessment of Pilosella officinarum Vall. (syn Hieracium pilosella L.), herba cum radice - Revision 1","type":"herbal-references","status":"unknown","consultation_date":"","first_published_date":"2025-02-26T09:39:20Z","last_updated_date":"2025-02-26T09:39:20Z","reference_number":"EMA/HMPC/103855/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-pilosella-officinarum-vall-syn-hieracium-pilosella-l-herba-cum-radice-revision-1_en.pdf"},
    {"id":"66979","name":"Final European Union herbal monograph on Pilosella officinarum Vall. (syn Hieracium pilosella L.), herba cum radice - Revision 1","type":"herbal-monograph","status":"unknown","consultation_date":"","first_published_date":"2025-02-26T09:40:10Z","last_updated_date":"2025-02-26T09:40:10Z","reference_number":"EMA/HMPC/493453/2023","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-pilosella-officinarum-vall-syn-hieracium-pilosella-l-herba-cum-radice-revision-1_en.pdf"},
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    {"id":"63090","name":"Questions and answers on the withdrawal of application for the marketing authorisation of GeGant (germanium [68Ge] chloride /gallium [68Ga] chloride)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2024-04-26T12:00:00Z","last_updated_date":"2025-02-26T13:44:00Z","reference_number":"EMA/171931/2024","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-gegant-germanium-68ge-chloride-gallium-68ga-chloride_sv.pdf"}},
    {"id":"66992","name":"Presentation - PMS Project Made Easy: Summary of activities and practical tips for SMEs​ (Marcos Fernandez Gomez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-26T14:07:08Z","last_updated_date":"2025-02-26T14:07:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pms-project-made-easy-summary-activities-practical-tips-smes-marcos-fernandez-gomez_en.pdf"},
    {"id":"64210","name":"Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals","type":"scientific-guideline","status":"Adopted","consultation_date":"2024-07-19 - 2024-10-31","first_published_date":"2024-07-19T10:38:00Z","last_updated_date":"2025-02-26T10:16:40Z","reference_number":"EMA/52912/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/addendum-guideline-clinical-development-vaccines-address-clinical-trials-immunocompromised-individuals_en.pdf"},
    {"id":"67028","name":"Presentation - Webinar for veterinary marketing authorisation holders on an industry dedicated read-only API","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-02-27T17:31:23Z","last_updated_date":"2025-02-27T17:31:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-webinar-veterinary-marketing-authorisation-holders-industry-dedicated-read-only-api_en.pdf"},
    {"id":"67029","name":"Minutes of the CAT meeting 22-24 January 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-02-27T17:41:40Z","last_updated_date":"2025-02-27T17:41:40Z","reference_number":"EMA/CAT/73821/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-22-24-january-2025_en.pdf"},
    {"id":"66988","name":"Withdrawal assessment report for GeGant (germanium (68Ge) chloride / gallium (68Ga) chloride)","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2025-02-26T13:45:03Z","last_updated_date":"2025-02-26T13:45:03Z","reference_number":"EMA/247635/2024","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-gegant-germanium-68ge-chloride-gallium-68ga-chloride_en.pdf"},
    {"id":"67042","name":"CHMP post-authorisation summary of positive opinion for Tremfya (X-43-G)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T10:36:11Z","last_updated_date":"2025-02-28T10:36:11Z","reference_number":"EMA/CHMP/54843/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-tremfya-x-43-g_en.pdf"},
    {"id":"6628","name":"Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2006-07-12T02:00:00Z","last_updated_date":"2025-02-28T10:53:00Z","reference_number":"EMA/151751/2010 Rev.4","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-chmp-cat-prac-rapporteur-co-rapporteur-appointment-principles-objective-criteria-methodology-accordance-article-62-1-regulation-ec-no-726-2004_en.pdf"},
    {"id":"67049","name":"Withdrawal letter: Bimervax (II-0016)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-02-28T11:49:56Z","last_updated_date":"2025-02-28T11:49:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-bimervax-ii-0016_en.pdf"},
    {"id":"67051","name":"Withdrawal letter: Dupixent (II-0083)","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-02-28T11:52:14Z","last_updated_date":"2025-02-28T11:52:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-dupixent-ii-0083_en.pdf"},
    {"id":"67048","name":"Questions and answers on the withdrawal of application to change the marketing authorisation for Bimervax (COVID-19 vaccine (recombinant, adjuvanted)) (II-0016)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-02-28T11:48:46Z","last_updated_date":"2025-02-28T11:48:46Z","reference_number":"EMA/66891/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-bimervax-covid-19-vaccine-recombinant-adjuvanted-ii-0016_en.pdf"},
    {"id":"66989","name":"CHMP post-authorisation summary of positive opinion for Abrysvo II-07","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/564741/2024","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-abrysvo-ii-07_en.pdf"},
    {"id":"67025","name":"CHMP post-authorisation summary of positive opinion for Supemtek Tetra II-21-G","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/56849/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-supemtek-tetra-ii-21-g_en.pdf"},
    {"id":"67026","name":"CHMP post-authorisation summary of positive opinion for Prevymis X-37-G","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/65082/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-prevymis-x-37-g_en.pdf"},
    {"id":"67043","name":"CHMP post-authorisation summary of positive opinion for Stelara II-108","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/57839/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-stelara-ii-108_en.pdf"},
    {"id":"67044","name":"CHMP post-authorisation summary of positive opinion for Imfinzi (II-64)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/63977/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imfinzi-ii-64_en.pdf"},
    {"id":"67036","name":"CHMP summary of positive opinion for Trabectedin Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T09:39:51Z","last_updated_date":"2025-02-28T09:39:51Z","reference_number":"EMA/CHMP/559896/2024","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-trabectedin-accord_en.pdf"},
    {"id":"67046","name":"CHMP post-authorisation summary of positive opinion for Kaftrio WS-2551","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/62074/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kaftrio-ws-2551_en.pdf"},
    {"id":"67047","name":"CHMP post-authorisation summary of positive opinion for Kalydeco WS-2551","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/64893/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-kalydeco-ws-2551_en.pdf"},
    {"id":"67052","name":"CHMP post-authorisation summary of positive opinion for Columvi (II-05)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/54323/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-columvi-ii-05_en.pdf"},
    {"id":"67041","name":"CHMP post-authorisation summary of positive opinion for Rinvoq (II-56)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/55472/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-rinvoq-ii-56_en.pdf"},
    {"id":"67022","name":"CHMP summary of positive opinion for Vyjuvek","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/52904/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vyjuvek_en.pdf"},
    {"id":"67020","name":"CHMP post-authorisation summary of positive opinion for Ixchiq (II-01)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/62534/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-ixchiq-ii-01_en.pdf"},
    {"id":"67021","name":"CHMP summary of positive opinion for Lynozyfic","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T15:02:12Z","last_updated_date":"2025-02-28T15:02:12Z","reference_number":"EMA/CHMP/48992/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-lynozyfic_en.pdf"},
    {"id":"67024","name":"CHMP summary of positive opinion for Deqsiga","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/2527/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-deqsiga_en.pdf"},
    {"id":"65651","name":"CHMP summary of positive opinion for Leqembi","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-11-14T16:44:43Z","last_updated_date":"2025-02-28T13:52:00Z","reference_number":"EMA/CHMP/530551/2024 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-leqembi_en.pdf"},
    {"id":"65647","name":"Questions and answers on: the approval of the marketing authorisation for Leqembi (lecanemab)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2024-11-14T16:25:39Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/36867/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-approval-marketing-authorisation-leqembi-lecanemab_en.pdf"},
    {"id":"67034","name":"CHMP post-authorisation summary of positive opinion for Fabhalta (II-01)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/327/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-fabhalta-ii-01_en.pdf"},
    {"id":"67033","name":"CHMP post-authorisation summary of positive opinion for Enhertu (II-48)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/67229/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-enhertu-ii-48_en.pdf"},
    {"id":"67016","name":"CHMP post-authorisation summary of positive opinion for Jaypirca (II-02)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/50600/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-jaypirca-ii-02_en.pdf"},
    {"id":"67015","name":"CHMP post-authorisation summary of positive opinion for Darzalex (II-76)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-02-28T12:00:00Z","reference_number":"EMA/CHMP/50155/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-ii-76_en.pdf"},
    {"id":"16038","name":"Opinion of the Committee on Herbal Medicinal Products on a community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum - Superseded","type":"herbal-opinion","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2025-02-28T02:00:00Z","reference_number":"EMA/HMPC/283230/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-committee-herbal-medicinal-products-community-herbal-monograph-eucalyptus-globulus-labill-eucalyptus-polybractea-rt-baker-or-eucalyptus-smithii-rt-baker-aetheroleum-superseded_en.pdf"},
    {"id":"41408","name":"Final Community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum - Superseded","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2025-02-28T02:00:00Z","reference_number":"EMA/HMPC/307781/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-community-herbal-monograph-eucalyptus-globulus-labill-eucalyptus-polybractea-rt-baker-or-eucalyptus-smithii-rt-baker-aetheroleum-superseded_en.pdf"},
    {"id":"5089","name":"Final assessment report on Eucalytus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum - Superseded","type":"herbal-report","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2025-02-28T02:00:00Z","reference_number":"EMA/HMPC/307782/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/final-assessment-report-eucalytus-globulus-labill-eucalyptus-polybractea-rt-baker-or-eucalyptus-smithii-rt-baker-aetheroleum-superseded_en.pdf"},
    {"id":"6878","name":"Final list of references supporting the assessment of Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum - Superseded","type":"herbal-references","status":"Adopted","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2025-02-28T02:00:00Z","reference_number":"EMA/HMPC/307783/2012","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/final-list-references-supporting-assessment-eucalyptus-globulus-labill-eucalyptus-polybractea-rt-baker-or-eucalyptus-smithii-rt-baker-aetheroleum-superseded_en.pdf"},
    {"id":"3489","name":"Overview of comments received on Community herbal monograph on Eucalyptus globulus Labill., Eucalyptus polybractea R.T. Baker and/or Eucalyptus smithii R.T. Baker, aetheroleum - Superseded","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2014-05-13T02:00:00Z","last_updated_date":"2025-02-28T02:00:00Z","reference_number":"EMA/HMPC/32373/2014","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-community-herbal-monograph-eucalyptus-globulus-labill-eucalyptus-polybractea-rt-baker-or-eucalyptus-smithii-rt-baker-aetheroleum-superseded_en.pdf"},
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    {"id":"67122","name":"P/0457/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for macitentan (Opsumit), (EMEA-001032-PIP01-10-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-06T10:10:49Z","last_updated_date":"2025-03-06T10:10:49Z","reference_number":"EMA/517330/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0457-2023-ema-decision-1-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-macitentan-opsumit-emea-001032-pip01-10-m07_en.pdf"},
    {"id":"59076","name":"P/0470/2023 : EMA decision of of 1 December 2023 on the refusal of a modification of an agreed paediatric investigation plan for lacosamide (Vimpat),  (EMEA-000402-PIP03-17-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2023-06-23T12:46:00Z","last_updated_date":"2025-03-06T13:34:00Z","reference_number":"EMA/512497/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0470-2023-ema-decision-1-december-2023-refusal-modification-agreed-paediatric-investigation-plan-lacosamide-vimpat-emea-000402-pip03-17-m08_en.pdf"},
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    {"id":"63794","name":"Guideline on the conduct of efficacy studies for intramammary products for use in cattle - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"2024-06-28 - 2024-10-31","first_published_date":"2024-06-28T13:00:00Z","last_updated_date":"2025-02-21T11:24:00Z","reference_number":"EMA/CVMP/344/1999 Rev.3*","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-efficacy-studies-intramammary-products-use-cattle-revision-3_en.pdf"},
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    {"id":"66105","name":"CHMP summary of positive opinion for Emcitate","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2024-12-13T10:37:34Z","last_updated_date":"2025-03-11T11:22:00Z","reference_number":"EMA/49758/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-emcitate_en.pdf"},
    {"id":"67185","name":"Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting 24-27 February 2025","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2025-03-11T13:59:08Z","last_updated_date":"2025-03-11T13:59:08Z","reference_number":"EMA/63235/2025","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-24-27-february-2025_en.pdf"},
    {"id":"23293","name":"Overview of comments received on the 'Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 1 (second version)'","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2016-02-03T12:00:00Z","last_updated_date":"2016-02-03T12:00:00Z","reference_number":"EMA/CVMP/EWP/374087/2015","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances-revision-1-second-version_en.pdf"},
    {"id":"25027","name":"Draft guideline for the demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Revision 1 (second version)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2015-03-04 - 2015-05-31","first_published_date":"2015-03-04T17:00:00Z","last_updated_date":"2015-03-04T17:00:00Z","reference_number":"EMA/CVMP/261180/2012","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances-revision-1-second-version_en.pdf"},
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    {"id":"25079","name":"Superseded Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version","type":"herbal-monograph","status":"Adopted","consultation_date":"","first_published_date":"2012-11-05T12:20:00Z","last_updated_date":"2025-03-12T12:20:00Z","reference_number":"EMA/HMPC/461160/2008","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/superseded-community-herbal-monograph-urtica-dioica-l-urtica-urens-l-their-hybrids-or-their-mixtures-radix-first-version_en.pdf"},
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    {"id":"67239","name":"Unregulated advanced therapy medicinal products pose serious risks to health","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2025-03-13T12:00:00Z","last_updated_date":"2025-03-13T12:00:00Z","reference_number":"EMA/66537/2025","document_url":"https://www.ema.europa.eu/en/documents/public-statement/unregulated-advanced-therapy-medicinal-products-pose-serious-risks-health_en.pdf"},
    {"id":"67259","name":"P/0036/2024 : EMA decision of 31 January 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ferric citrate coordination complex (FCCC), (EMEA-001213-PIP03-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-13T15:25:50Z","last_updated_date":"2025-03-13T15:25:50Z","reference_number":"EMA/22039/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0036-2024-ema-decision-31-january-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ferric-citrate-coordination-complex-fccc-emea-001213-pip03-23_en.pdf"},
    {"id":"67260","name":"Addendum to Assessment report on Sambucus nigra L., flos","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2025-03-13T15:44:31Z","last_updated_date":"2025-03-13T15:44:31Z","reference_number":"EMA/HMPC/438159/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-sambucus-nigra-l-flos_en.pdf"},
    {"id":"67262","name":"Addendum to Assessment report on Verbascum thapsus L.; V. densiflorum Bertol. (V.,thapsiforme Schrad); V. phlomoides L., flos","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2025-03-13T15:48:44Z","last_updated_date":"2025-03-13T15:48:44Z","reference_number":"EMA/HMPC/438161/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-verbascum-thapsus-l-v-densiflorum-bertol-vthapsiforme-schrad-v-phlomoides-l-flos_en.pdf"},
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    {"id":"67227","name":"Agenda - Management Board meeting: 13 March 2025","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-03-12T11:16:42Z","last_updated_date":"2025-03-14T15:10:29Z","reference_number":"EMA/MB/45410/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-management-board-meeting-13-march-2025_en.pdf"},
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    {"id":"67805","name":"Presentation - ACT EU workplan 2025-2026 (L. Pioppo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T15:53:12Z","last_updated_date":"2025-04-14T15:53:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-act-eu-workplan-2025-2026-l-pioppo_en.pdf"},
    {"id":"67806","name":"Presentation - Feedback from ACT EU workshop on ICH E6 R3 (P. Twomey, K. Pietsch and F. Houÿez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T15:54:22Z","last_updated_date":"2025-04-14T15:54:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-feedback-act-eu-workshop-ich-e6-r3-p-twomey-k-pietsch-f-houyez_en.pdf"},
    {"id":"67807","name":"Presentation - Update on Multistakeholder platform (A. Zanoletty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T15:56:30Z","last_updated_date":"2025-04-14T15:56:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-multistakeholder-platform-zanoletty_en.pdf"},
    {"id":"67808","name":"Presentation - Risk minimisation in healthcare: updates on policy, practice, research and engagement (P. Bahri)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T15:57:53Z","last_updated_date":"2025-04-14T15:57:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-minimisation-healthcare-updates-policy-practice-research-engagement-p-bahri_en.pdf"},
    {"id":"67809","name":"Presentation - Update on EMA policy on competing interests (policy 0044) (Z. Hanaizi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T15:59:09Z","last_updated_date":"2025-04-14T15:59:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ema-policy-competing-interests-policy-0044-z-hanaizi_en.pdf"},
    {"id":"67810","name":"Presentation - EMANS to 2028 (M. Carr and R. Santos)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:00:19Z","last_updated_date":"2025-04-14T16:00:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emans-2028-m-carr-r-santos_en.pdf"},
    {"id":"67811","name":"Presentation - Update of the QRD template: revision of the package leaflet (M. Buch)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:01:13Z","last_updated_date":"2025-04-14T16:01:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-qrd-template-revision-package-leaflet-m-buch_en.pdf"},
    {"id":"67812","name":"Presentation - Electronic product information (ePI) pilot and next steps (E. Scanlan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:02:32Z","last_updated_date":"2025-04-14T16:02:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-electronic-product-information-epi-pilot-next-steps-e-scanlan_en.pdf"},
    {"id":"67813","name":"Presentation - European Patients Forum’s statement (S. Jouan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:03:29Z","last_updated_date":"2025-04-14T16:03:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-patients-forums-statement-s-jouan_en.pdf"},
    {"id":"67814","name":"Presentation - Joint statement on ePI (D. Teixeira Pereira)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:10:50Z","last_updated_date":"2025-04-14T16:10:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-joint-statement-epi-d-teixeira-pereira_en.pdf"},
    {"id":"67815","name":"Presentation - Introduction to shortages topic (M. Dias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:12:57Z","last_updated_date":"2025-04-14T16:12:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-shortages-topic-m-dias_en.pdf-0"},
    {"id":"67816","name":"Presentation - Transfer of Task Force on Availability of Authorised Medicines for Human and Veterinary Use activities (TF-AAM) and The Working Group of the MSSG on the Vulnerability Assessment Methodology (V. Bennett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:13:50Z","last_updated_date":"2025-04-14T16:13:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-transfer-task-force-availability-authorised-medicines-human-veterinary-use-activities-tf-aam-working-group-mssg-vulnerability-assessment-methodology-v-bennett_en.pdf"},
    {"id":"67817","name":"Presentation - Ongoing critical shortages (K. Kruttwig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:16:08Z","last_updated_date":"2025-04-14T16:16:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ongoing-critical-shortages-k-kruttwig_en.pdf"},
    {"id":"67818","name":"Presentation - European Shortages Monitoring Platform (ESMP) update (S. Zastavnik)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:17:10Z","last_updated_date":"2025-04-14T16:17:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-shortages-monitoring-platform-esmp-update-s-zastavnik_en.pdf"},
    {"id":"67819","name":"Presentation - CAT committee feedback (K. Sollerbrant)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:18:04Z","last_updated_date":"2025-04-14T16:18:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cat-committee-feedback-k-sollerbrant_en.pdf"},
    {"id":"67820","name":"Presentation - COMP committee feedback (I. Alves and J. Rocha)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:19:24Z","last_updated_date":"2025-04-14T16:19:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-comp-committee-feedback-i-alves-j-rocha_en.pdf"},
    {"id":"67821","name":"Presentation - HMPC committee feedback (An Lê)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:20:56Z","last_updated_date":"2025-04-14T16:20:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hmpc-committee-feedback-le_en.pdf"},
    {"id":"67822","name":"Presentation - PDCO committee feedback (J. Taminiau)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:22:11Z","last_updated_date":"2025-04-14T16:22:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pdco-committee-feedback-j-taminiau_en.pdf"},
    {"id":"67823","name":"Presentation - Data Analysis and Real World Interrogation Network (DARWIN EU): Three years of a journey (A. Segec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:23:19Z","last_updated_date":"2025-04-14T16:23:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-analysis-real-world-interrogation-network-darwin-eu-three-years-journey-segec_en.pdf"},
    {"id":"67824","name":"Presentation - Update on Patient Experience Data (PED) reflection paper (K. Immonen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:24:49Z","last_updated_date":"2025-04-14T16:24:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-patient-experience-data-ped-reflection-paper-k-immonen_en.pdf"},
    {"id":"67825","name":"Presentation - Call for PCWP and HCPWP mandate 2025-2028 (M. Bonafonte and I. Silva)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:26:11Z","last_updated_date":"2025-04-14T16:26:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-call-pcwp-hcpwp-mandate-2025-2028-m-bonafonte-i-silva_en.pdf"},
    {"id":"67826","name":"Presentation - Information on election of PCWP and HCPWP co-chairs (M. Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:27:34Z","last_updated_date":"2025-04-14T16:27:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-election-pcwp-hcpwp-co-chairs-m-mavris_en.pdf"},
    {"id":"67827","name":"Presentation - Highlights of PCWP HCPWP 2023-2025 mandate (M. Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:28:50Z","last_updated_date":"2025-04-14T16:28:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-highlights-pcwp-hcpwp-2023-2025-mandate-m-mavris_en.pdf"},
    {"id":"67828","name":"Presentation - Information ecosystem management (R. Gonzalez-Quevedo and S. Labbe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T16:45:27Z","last_updated_date":"2025-04-14T16:45:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-ecosystem-management-r-gonzalez-quevedo-s-labbe_en.pdf"},
    {"id":"67829","name":"Presentation - Update on communication campaigns (G. Gabrielli and C. Enachioiu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T17:02:47Z","last_updated_date":"2025-04-14T17:02:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-communication-campaigns-g-gabrielli-c-enachioiu_en.pdf"},
    {"id":"67830","name":"Presentation - Cross-agency One Health Task Force (A. Vidal)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T17:04:08Z","last_updated_date":"2025-04-14T17:04:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cross-agency-one-health-task-force-vidal_en.pdf"},
    {"id":"67831","name":"Presentation - 10 years of experience of patient involvement EMA, opportunities, challenges and learnings for meaningful patient involvement (E. Vroom, D. Athanasiou)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T17:05:15Z","last_updated_date":"2025-04-14T17:05:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-10-years-experience-patient-involvement-ema-opportunities-challenges-learnings-meaningful-patient-involvement-e-vroom-d-athanasiou_en.pdf"},
    {"id":"67832","name":"Presentation - Preparing future roles for patients and HCP in EMA committees PRAC-CHMP (F. Houyez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T17:06:39Z","last_updated_date":"2025-04-14T17:06:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-preparing-future-roles-patients-hcp-ema-committees-prac-chmp-f-houyez_en.pdf"},
    {"id":"67836","name":"Busulfan : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"67788","name":"Quality Review of Documents (QRD) annotated template v11: Form for submission of comments to public consultation","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-04-14T15:38:00Z","last_updated_date":"2025-04-14T15:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/quality-review-documents-qrd-annotated-template-v11-form-submission-comments-public-consultation_en.docx"},
    {"id":"67850","name":"Questions and answers - European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-04-15T13:51:15Z","last_updated_date":"2025-04-15T13:51:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-answers-european-shortages-monitoring-platform-esmp-workshop-application-programming-interface-api-marketing-authorisation-holders-mahs_en.pdf"},
    {"id":"26277","name":"Policy 26: Records management and archives policy","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2010-04-22T02:00:00Z","last_updated_date":"2025-04-15T12:05:00Z","reference_number":"EMA/16533/2024","document_url":"https://www.ema.europa.eu/en/documents/other/policy-26-records-management-archives-policy_en.pdf"},
    {"id":"66409","name":"Tracked product information annexes statement translation for cover page","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-02-10T09:53:35Z","last_updated_date":"2025-04-15T14:59:17Z","reference_number":"EMA/38725/2025 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/template-form/tracked-product-information-annexes-statement-translation-cover-page_en.docx"},
    {"id":"67869","name":"Minutes of the CVMP meeting 11-13 March 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-04-16T11:41:52Z","last_updated_date":"2025-04-16T11:41:52Z","reference_number":"EMA/CVMP/125927/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cvmp-meeting-11-13-march-2025_en.pdf"},
    {"id":"67873","name":"Sotalol : List of nationally authorised medicinal products - PSUSA/00002774/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-16T12:18:25Z","last_updated_date":"2025-04-16T12:18:25Z","reference_number":"EMA/134275/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/sotalol-list-nationally-authorised-medicinal-products-psusa-00002774-202408_en.pdf"},
    {"id":"67876","name":"Overview of comments received on ICH M15 Guideline on general principles for model informed drug development (EMA/CHMP/ICH/496426/2024)","type":"scientific-guideline","status":"unknown","consultation_date":"","first_published_date":"2025-04-16T12:56:15Z","last_updated_date":"2025-04-16T12:56:15Z","reference_number":"EMA/91404/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/overview-comments-received-ich-m15-guideline-general-principles-model-informed-drug-development-ema-chmp-ich-496426-2024_en.pdf"},
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    {"id":"64577","name":"Final European Union herbal monograph on Cisti cretici herba – First version","type":"herbal-monograph","status":"Adopted","consultation_date":"2024-08-15 - 2024-11-15","first_published_date":"2024-08-14T16:25:58Z","last_updated_date":"2025-04-30T15:38:00Z","reference_number":"EMA/HMPC/150763/2015","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/final-european-union-herbal-monograph-cisti-cretici-herba-first-version_en.pdf"},
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    {"id":"68041","name":"Opinion of the HMPC on a European Union herbal monograph on Cistus creticus L., herba","type":"herbal-opinion","status":"unknown","consultation_date":"","first_published_date":"2025-04-30T15:41:43Z","last_updated_date":"2025-04-30T15:41:43Z","reference_number":"EMA/HMPC/116483/2025","document_url":"https://www.ema.europa.eu/en/documents/herbal-opinion/opinion-hmpc-european-union-herbal-monograph-cistus-creticus-l-herba_en.pdf"},
    {"id":"68042","name":"Overview of comments received on European Union herbal monograph on Cistus creticus L., herba","type":"herbal-comments","status":"unknown","consultation_date":"","first_published_date":"2025-04-30T15:43:22Z","last_updated_date":"2025-04-30T15:43:22Z","reference_number":"EMA/HMPC/9713/2025","document_url":"https://www.ema.europa.eu/en/documents/herbal-comments/overview-comments-received-european-union-herbal-monograph-cistus-creticus-l-herba_en.pdf"},
    {"id":"68043","name":"Addendum to Assessment report on Gentiana lutea L., radix","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2025-04-30T15:53:04Z","last_updated_date":"2025-04-30T15:53:04Z","reference_number":"EMA/HMPC/3544/2025","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-gentiana-lutea-l-radix_en.pdf"},
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    {"id":"68046","name":"Addendum to Assessment report on Arctostaphylos uva-ursi (L.) Spreng., folium","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2025-04-30T16:00:12Z","last_updated_date":"2025-04-30T16:00:12Z","reference_number":"EMA/HMPC/320360/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-arctostaphylos-uva-ursi-l-spreng-folium_en.pdf"},
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    {"id":"66530","name":"Draft reflection paper on the qualification of non-mutagenic impurities ","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-01-30 - 2025-04-30","first_published_date":"2025-01-30T13:43:41Z","last_updated_date":"2025-01-30T13:43:41Z","reference_number":"EMA/CHMP/543397/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-qualification-non-mutagenic-impurities_en.pdf"},
    {"id":"66554","name":"Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-02-01 - 2025-05-01","first_published_date":"2025-01-31T13:26:19Z","last_updated_date":"2025-01-31T13:26:19Z","reference_number":"EMA/HMPC/224438/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-use-information-european-union-herbal-monographs-assessment-reports-borderline-issues_en.pdf"},
    {"id":"68048","name":"Small and medium-sized enterprise (SME) office annual report 2024","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-05-02T10:25:50Z","last_updated_date":"2025-05-02T10:25:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/small-medium-sized-enterprise-sme-office-annual-report-2024_en.pdf"},
    {"id":"23666","name":"Guideline on EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies - Obsolete","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2002-06-17T02:00:00Z","last_updated_date":"2002-06-17T02:00:00Z","reference_number":"EMEA/CVMP/552/02-CONS.","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-eu-requirements-batches-maximum-minimum-titre-or-batch-potency-developmental-safety-efficacy-studies-obsolete_en.pdf"},
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    {"id":"66287","name":"Minutes of the 125th meeting of the EMA Management Board: 3 October 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-01-10T14:41:11Z","last_updated_date":"2025-01-10T14:41:11Z","reference_number":"EMA/MB/449773/2024","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-125th-meeting-ema-management-board-3-october-2024_en.pdf"},
    {"id":"65117","name":"Agenda for the 125th meeting of the EMA Management Board: 3 October 2024","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2024-10-02T14:35:29Z","last_updated_date":"2024-10-03T15:21:00Z","reference_number":"EMA/MB/377084/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-125th-meeting-ema-management-board-3-october-2024_en.pdf"},
    {"id":"68163","name":"Certificates Processing System: third demo and Q&A session for industry stakeholders (H+V)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T11:13:00Z","last_updated_date":"2025-05-08T11:13:00Z","reference_number":"EMA/156481/2025","document_url":"https://www.ema.europa.eu/en/documents/other/certificates-processing-system-third-demo-qa-session-industry-stakeholders-hv_en.pdf"},
    {"id":"53041","name":"Concept paper on the revision of annex 5 of the guidelines on good manufacturing practice for medicinal products – manufacture of immunological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-11-09 - 2022-01-09","first_published_date":"2021-11-09T16:52:00Z","last_updated_date":"2021-11-09T16:52:00Z","reference_number":"EMA/628491/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-annex-5-guidelines-good-manufacturing-practice-medicinal-products-manufacture-immunological-veterinary-medicinal-products_en.pdf"},
    {"id":"53040","name":"Concept paper on the revision of annex 4 of the guidelines on good manufacturing practice – manufacture of veterinary medicinal products other than immunologicals","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2021-11-09 - 2022-01-09","first_published_date":"2021-11-09T16:48:00Z","last_updated_date":"2021-11-09T16:48:00Z","reference_number":"EMA/628488/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-annex-4-guidelines-good-manufacturing-practice-manufacture-veterinary-medicinal-products-other-immunologicals_en.pdf"},
    {"id":"52149","name":"Reflection paper on good manufacturing practice and marketing authorisation holders","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-07-29T14:58:00Z","last_updated_date":"2022-01-14T11:46:00Z","reference_number":"EMA/419571/2021 Version 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-good-manufacturing-practice-marketing-authorisation-holders_en.pdf"},
    {"id":"9794","name":"Concept paper on good manufacturing practice and marketing authorisation holders","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2016-10-01 - 2016-12-31","first_published_date":"2016-10-04T04:00:00Z","last_updated_date":"2016-10-20T21:05:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-good-manufacturing-practice-marketing-authorisation-holders_en.pdf"},
    {"id":"68180","name":"Annex 6 - Substrate-Inhibitor Matrix for CYP competitive and mechanism-based inhibition of CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4/5","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:12:42Z","last_updated_date":"2025-05-08T15:12:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-substrate-inhibitor-matrix-cyp-competitive-mechanism-based-inhibition-cyp1a2-cyp2c8-cyp2c9-cyp2c19-cyp3a4-5_en.pdf"},
    {"id":"68181","name":"Annex 6 - Briefing document - Qualification of the effects of invetsigational drugs as victims or perpetrators of CYP=mediated drug interactions involving inhibition in the Simcyp Simulator","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:13:35Z","last_updated_date":"2025-05-08T15:13:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-briefing-document-qualification-effects-invetsigational-drugs-victims-or-perpetrators-cypmediated-drug-interactions-involving-inhibition-simcyp-simulator_en.pdf"},
    {"id":"68182","name":"Annex 6 - SAWP discussion meeting 15 January 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:15:19Z","last_updated_date":"2025-05-08T15:15:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-sawp-discussion-meeting-15-january-2025_en.pdf"},
    {"id":"68183","name":"Annex 6 - SAWP discussion meeting 10 July 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:16:14Z","last_updated_date":"2025-05-08T15:16:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-sawp-discussion-meeting-10-july-2024_en.pdf"},
    {"id":"68185","name":"Annex 6 - Preparation meeting 21 February 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:17:47Z","last_updated_date":"2025-05-08T15:17:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-preparation-meeting-21-february-2023_en.pdf"},
    {"id":"68191","name":"Annex 6 - CYPDDI document","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:23:43Z","last_updated_date":"2025-05-08T15:23:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-cypddi-document_en.pdf"},
    {"id":"68170","name":"PRAC statistics: May 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T14:15:44Z","last_updated_date":"2025-05-08T14:15:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/prac-statistics-may-2025_en.pdf"},
    {"id":"68192","name":"Annex 6 - Additional supporting documentation – System parameters and compound files","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:24:24Z","last_updated_date":"2025-05-08T15:24:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-additional-supporting-documentation-system-parameters-compound-files_en.pdf"},
    {"id":"68193","name":"Annex 6 - Fluvoxamine summary March 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:26:23Z","last_updated_date":"2025-05-08T15:26:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-fluvoxamine-summary-march-2025_en.pdf"},
    {"id":"68194","name":"Annex 6 - Response to EMA","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:27:43Z","last_updated_date":"2025-05-08T15:27:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema_en.pdf"},
    {"id":"68189","name":"Annex 6 - Response to EMA 9 April 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:21:05Z","last_updated_date":"2025-05-08T15:21:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-9-april-2025_en.pdf"},
    {"id":"68187","name":"Annex 6 - Response to EMA 16 December 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:19:59Z","last_updated_date":"2025-05-08T15:19:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-16-december-2024_en.pdf"},
    {"id":"68186","name":"Annex 6 - Response to EMA 18 March 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:18:51Z","last_updated_date":"2025-05-08T15:18:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-18-march-2025_en.pdf"},
    {"id":"68196","name":"Annex 6 - Response to EMA 21 December 2023","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:33:34Z","last_updated_date":"2025-05-08T15:33:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-21-december-2023_en.pdf"},
    {"id":"68197","name":"Annex 6 - Response to EMA 26 June 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:34:12Z","last_updated_date":"2025-05-08T15:34:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-26-june-2024_en.pdf"},
    {"id":"68198","name":"Annex 6 - DDI qualification matrix","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:34:50Z","last_updated_date":"2025-05-08T15:34:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-ddi-qualification-matrix_en.pdf"},
    {"id":"68199","name":"Annex 6 - V19R1 vs V20R1 version comparison","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:36:15Z","last_updated_date":"2025-05-08T15:36:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-v19r1-vs-v20r1-version-comparison_en.pdf"},
    {"id":"68201","name":"Annex 6 - V21R1 vs V22R1 version comparison","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:37:32Z","last_updated_date":"2025-05-08T15:37:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-v21r1-vs-v22r1-version-comparison_en.pdf"},
    {"id":"68202","name":"Annex 6 - V22R1 vs V23R2 version comparison","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:38:03Z","last_updated_date":"2025-05-08T15:38:03Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-v22r1-vs-v23r2-version-comparison_en.pdf"},
    {"id":"68190","name":"Annex 6 - Response to EMA 19 February 2025 (items 2-4)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:22:16Z","last_updated_date":"2025-05-08T15:22:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-19-february-2025-items-2-4_en.pdf"},
    {"id":"68188","name":"Annex 6 - Response to EMA 19 February 2025 (items 1 and 5)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:20:34Z","last_updated_date":"2025-05-08T15:20:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-response-ema-19-february-2025-items-1-5_en.pdf"},
    {"id":"68200","name":"Annex 6 - V20R1 vs V21R1 version comparison","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:36:59Z","last_updated_date":"2025-05-08T15:36:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-v20r1-vs-v21r1-version-comparison_en.pdf"},
    {"id":"68184","name":"Annex 6 - SAWP discussion meeting 6 March 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:16:53Z","last_updated_date":"2025-05-08T15:16:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-6-sawp-discussion-meeting-6-march-2024_en.pdf"},
    {"id":"68173","name":"Annex 1 - Bayesian Analysis","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:02:46Z","last_updated_date":"2025-05-08T15:02:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-1-bayesian-analysis_en.pdf"},
    {"id":"68174","name":"Annex 2 - Description of Systems models and related parameters for the full and minimal PBPK models","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:05:09Z","last_updated_date":"2025-05-08T15:05:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-2-description-systems-models-related-parameters-full-minimal-pbpk-models_en.pdf"},
    {"id":"68175","name":"Annex 3 - Simcyp Compound Summaries - Cimetidine","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:06:15Z","last_updated_date":"2025-05-08T15:06:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-3-simcyp-compound-summaries-cimetidine_en.pdf"},
    {"id":"68176","name":"Annex 3 - Simcyp Compound Summaries – Fluvoxamine","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:07:21Z","last_updated_date":"2025-05-08T15:07:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-3-simcyp-compound-summaries-fluvoxamine_en.pdf"},
    {"id":"68177","name":"Annex 3 - Simcyp Compound Summaries - Midazolam","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:07:53Z","last_updated_date":"2025-05-08T15:07:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-3-simcyp-compound-summaries-midazolam_en.pdf"},
    {"id":"68178","name":"Annex 4 - Evolution of DDI qualification matrix and substrates inhibitors","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:09:46Z","last_updated_date":"2025-05-08T15:09:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-4-evolution-ddi-qualification-matrix-substrates-inhibitors_en.pdf"},
    {"id":"68179","name":"Annex 5 - DDI Qualification Matrix","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T15:10:39Z","last_updated_date":"2025-05-08T15:10:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-5-ddi-qualification-matrix_en.pdf"},
    {"id":"68067","name":"EMA Gender equality plan 2025 - 2030","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T17:42:00Z","last_updated_date":"2025-05-08T17:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ema-gender-equality-plan-2025-2030_en.pdf"},
    {"id":"68210","name":"Ixchiq Article-20 procedure - PRAC list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T08:22:06Z","last_updated_date":"2025-05-12T08:22:06Z","reference_number":"EMA/PRAC/158050/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/ixchiq-article-20-procedure-prac-list-questions_en.pdf"},
    {"id":"68211","name":"Ixchiq Article-20 procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T08:24:46Z","last_updated_date":"2025-05-12T08:24:46Z","reference_number":"EMA/PRAC/157937/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/ixchiq-article-20-procedure-timetable-procedure_en.pdf"},
    {"id":"68217","name":"P/0080/2024 : EMA decision of 15 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Borrelia outer surface protein A (OspA) serotypes (ST1-6) lipidated, fusion protein","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-05-12T12:03:13Z","last_updated_date":"2025-05-12T12:03:13Z","reference_number":"EMA/28245/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0080-2024-ema-decision-15-march-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-borrelia-outer-surface-protein-ospa-serotypes-st1-6-lipidated-fusion-protein_en.pdf"},
    {"id":"68218","name":"P/0079/2024: EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP04-17-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-05-12T12:14:15Z","last_updated_date":"2025-05-12T12:14:15Z","reference_number":"EMA/89850/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0079-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-rinvoq-emea-001741-pip04-17-m05_en.pdf"},
    {"id":"68219","name":"Medicine shortage communication (MSC): Fiasp PumpCart and NovoRapid PumpCart","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T12:35:00Z","last_updated_date":"2025-05-12T12:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/medicine-shortage-communication-msc-fiasp-pumpcart-novorapid-pumpcart_en.pdf"},
    {"id":"68227","name":"Opium : List of nationally authorised medicinal products - PSUSA/00010670/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T14:46:08Z","last_updated_date":"2025-05-12T14:46:08Z","reference_number":"EMA/160332/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/opium-list-nationally-authorised-medicinal-products-psusa-00010670-202409_en.pdf"},
    {"id":"68228","name":"Rilmenidine : EPAR - List of nationally authorised medicinal products - PSUSA/00002643/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T14:51:19Z","last_updated_date":"2025-05-12T14:51:19Z","reference_number":"EMA/160599/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/rilmenidine-epar-list-nationally-authorised-medicinal-products-psusa-00002643-202408_en.pdf"},
    {"id":"68232","name":"Naphazoline, naphazoline, zinc sulphate : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"68546","name":"EMA/PDCO summary report on the review of the list of granted Class Waivers 2 June 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-03T14:34:16Z","last_updated_date":"2025-06-03T14:34:16Z","reference_number":"EMADOC-1700519818-2008871","document_url":"https://www.ema.europa.eu/en/documents/other/ema-pdco-summary-report-review-list-granted-class-waivers-2-june-2025_en.pdf"},
    {"id":"68548","name":"European Medicines Agency decision CW/0001/2025 of 2 June 2025 on class waivers in accordance with Regulation EC No 1901-2006 of the European Parliament and of the Council","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-03T14:37:19Z","last_updated_date":"2025-06-03T14:37:19Z","reference_number":"EMADOC-1700519818-2155553","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agency-decision-cw-0001-2025-2-june-2025-class-waivers-accordance-regulation-ec-no-1901-2006-european-parliament-council_en.pdf"},
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    {"id":"68550","name":"Presentation - Update on CTIS programme - CTIS Info Day May 2025 (M. Sultani)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-06-03T14:38:12Z","last_updated_date":"2025-06-03T14:38:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ctis-programme-ctis-info-day-may-2025-m-sultani_en.pdf"},
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    {"id":"68558","name":"Presentation - Simplification and redesign of CTR/CTIS training material for Sponsors and Member States - CTIS Info Day May 2025 (F. Scotti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-06-03T15:01:51Z","last_updated_date":"2025-06-03T15:01:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-simplification-redesign-ctr-ctis-training-material-sponsors-member-states-ctis-info-day-may-2025-f-scotti_en.pdf"},
    {"id":"67856","name":"Role description: accounting coordinator","type":"recruitment","status":"unknown","consultation_date":"","first_published_date":"2025-04-15T14:32:49Z","last_updated_date":"2025-04-15T14:32:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/recruitment/role-description-accounting-coordinator_en.pdf"},
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    {"id":"67361","name":"Instructions on how to apply for a portfolio & technology meeting (PTM)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-03-20T09:39:47Z","last_updated_date":"2025-06-20T08:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/instructions-how-apply-portfolio-technology-meeting-ptm_en.pdf"},
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    {"id":"68862","name":"Finasteride- and dutasteride-containing medicinal products Article-31 referral - Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T10:52:54Z","last_updated_date":"2025-06-20T10:52:54Z","reference_number":"EMA/202053/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts-finasteride-dutasteride-medicines_en.pdf-0"},
    {"id":"68792","name":"CHMP summary of positive opinion for Vgenfli","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T12:00:00Z","last_updated_date":"2025-06-20T12:00:00Z","reference_number":"EMA/CHMP/193205/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vgenfli_en.pdf"},
    {"id":"68809","name":"CHMP summary of positive opinion for Usymro","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T12:00:00Z","last_updated_date":"2025-06-20T12:00:00Z","reference_number":"EMA/CHMP/138479/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-usymro_en.pdf"},
    {"id":"68171","name":"Finasteride- and dutasteride-containing medicinal products Article-31 referral - Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T14:49:20Z","last_updated_date":"2025-05-08T14:49:20Z","reference_number":"EMA/142716/2025 ","document_url":"https://www.ema.europa.eu/en/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-measures-minimise-risk-suicidal-thoughts-finasteride-dutasteride-medicines_en.pdf"},
    {"id":"65145","name":"Finasteride- and dutasteride-containing medicinal products Article-31 referral - Review started","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2024-10-04T11:11:01Z","last_updated_date":"2024-10-04T11:11:01Z","reference_number":"EMA/452263/2024","document_url":"https://www.ema.europa.eu/en/documents/referral/finasteride-dutasteride-containing-medicinal-products-article-31-referral-review-started_en.pdf"},
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    {"id":"68863","name":"CHMP summary of positive opinion for Vivlipeg","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T11:10:22Z","last_updated_date":"2025-06-20T11:10:22Z","reference_number":"EMA/CHMP/200894/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vivlipeg_en.pdf"},
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    {"id":"68790","name":"CHMP summary of positive opinion for Eiyzey","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T12:00:00Z","last_updated_date":"2025-06-20T12:00:00Z","reference_number":"EMA/CHMP/201926/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eiyzey_en.pdf"},
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    {"id":"68856","name":"CHMP post-authorisation summary of positive opinion for Nubeqa (II-24)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T09:57:57Z","last_updated_date":"2025-06-20T09:57:57Z","reference_number":"EMA/CHMP/141494/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-nubeqa-ii-24_en.pdf"},
    {"id":"68843","name":"CHMP post-authorisation summary of positive opinion for Imbruvica (II-92)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T16:58:33Z","last_updated_date":"2025-06-20T16:58:33Z","reference_number":"EMA/CHMP/200830/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-imbruvica-ii-92_en.pdf"},
    {"id":"68841","name":"CHMP summary of positive opinion for Rezdiffra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T14:52:54Z","last_updated_date":"2025-06-20T14:52:54Z","reference_number":"EMA/193903/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rezdiffra_en.pdf"},
    {"id":"68844","name":"CHMP post-authorisation summary of positive opinion for Cabometyx (II-40)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T12:00:00Z","last_updated_date":"2025-06-20T12:00:00Z","reference_number":"EMA/CHMP/201774/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cabometyx-ii-40_en.pdf"},
    {"id":"68838","name":"CHMP post-authorisation summary of positive opinion for Sarclisa (II-35)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T13:58:48Z","last_updated_date":"2025-06-20T13:58:48Z","reference_number":"EMA/CHMP/186923/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-sarclisa-ii-35_en.pdf"},
    {"id":"68833","name":"CHMP post-authorisation summary of positive opinion for Benlysta (II-133)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T13:30:46Z","last_updated_date":"2025-06-20T13:30:46Z","reference_number":"EMA/CHMP/177699/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-benlysta-ii-133_en.pdf"},
    {"id":"68827","name":"CHMP summary of positive opinion for Zemcelpro","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T12:00:00Z","last_updated_date":"2025-06-20T12:00:00Z","reference_number":"EMA/CHMP/189609/2025 ","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-zemcelpro_en.pdf"},
    {"id":"68820","name":"CHMP post-authorisation summary of positive opinion for Darzalex (II-77)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T12:00:00Z","last_updated_date":"2025-06-20T12:00:00Z","reference_number":"EMA/CHMP/144721/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-darzalex-ii-77_en.pdf"},
    {"id":"68858","name":"CHMP post-authorisation summary of positive opinion for Dapivirine Vaginal Ring 25 mg (II-27)","type":"outside-EU-smop","status":"unknown","consultation_date":"","first_published_date":"2025-06-20T10:10:50Z","last_updated_date":"2025-06-20T10:10:50Z","reference_number":"EMA/CHMP/199904/2025","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-smop/chmp-post-authorisation-summary-positive-opinion-dapivirine-vaginal-ring-25-mg-ii-27_en.pdf"},
    {"id":"68866","name":"Start of Union reviews adopted during the CHMP meeting of 16-19 June 2025","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T13:32:56Z","last_updated_date":"2025-06-20T13:32:56Z","reference_number":"EMA/202194/2025","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/start-union-reviews-adopted-during-chmp-meeting-16-19-june-2025_en.pdf"},
    {"id":"68868","name":"Agenda - Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system (October, December 2025)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-20T13:46:31Z","last_updated_date":"2025-06-20T13:46:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-virtual-live-hands-training-course-clinical-trials-sponsors-using-eudravigilance-system-october-december-2025_en.pdf"},
    {"id":"68876","name":"Sodium oxybate Article-31 referral  - EMA starts review of sodium oxybate in alcohol dependence","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-06-20T17:28:50Z","last_updated_date":"2025-06-20T17:28:50Z","reference_number":"EMA starts review of sodium oxybate in alcohol dependence","document_url":"https://www.ema.europa.eu/en/documents/referral/sodium-oxybate-article-31-referral-ema-starts-review-sodium-oxybate-alcohol-dependence_en.pdf"},
    {"id":"68877","name":"Sodium oxybate Article-31 referral - Annex I","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-06-20T17:36:00Z","last_updated_date":"2025-06-20T17:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sodium-oxybate-article-31-referral-annex-i_en.pdf"},
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    {"id":"68880","name":"Sodium oxybate Article-31 referral - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-06-20T17:42:47Z","last_updated_date":"2025-06-20T17:42:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/sodium-oxybate-article-31-referral-notification_en.pdf"},
    {"id":"65680","name":"Programme - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-23T16:10:17Z","last_updated_date":"2025-06-23T16:10:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-2025_en.pdf"},
    {"id":"68888","name":"Programme - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-11-18T15:44:59Z","last_updated_date":"2024-11-18T15:44:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-2025_en.pdf-0"},
    {"id":"68413","name":"Azithromycin Article-31 referral - Annex III","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-05-23T12:42:36Z","last_updated_date":"2025-06-23T16:48:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/azithromycin-article-31-referral-annex-iii_en.pdf"},
    {"id":"68887","name":"P/0242/2024: EMA decision of 19 July 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for ensitrelvir, (EMEA-003192-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-23T13:57:29Z","last_updated_date":"2025-06-23T13:57:29Z","reference_number":"EMA/323235/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0242-2024-ema-decision-19-july-2024-agreement-paediatric-investigation-plan-granting-deferral-ensitrelvir-emea-003192-pip02-23_en.pdf"},
    {"id":"68875","name":"P/0226/2024: EMA decision of 10 July 2024 on the granting of a product specific waiver for zanubrutinib (Brukinsa), (EMEA-002354-PIP03-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T16:08:59Z","last_updated_date":"2025-06-20T16:08:59Z","reference_number":"EMA/313177/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0226-2024-ema-decision-10-july-2024-granting-product-specific-waiver-zanubrutinib-brukinsa-emea-002354-pip03-24_en.pdf"},
    {"id":"68852","name":"P/0250/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for ifinatamab deruxtecan (EMEA-003613-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T09:38:30Z","last_updated_date":"2025-06-20T09:38:30Z","reference_number":"EMA/324726/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0250-2024-ema-decision-19-july-2024-granting-product-specific-waiver-ifinatamab-deruxtecan-emea-003613-pip01-24_en.pdf"},
    {"id":"68853","name":"P/0251/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for diclofenac (sodium) / thiocolchicoside (EMEA-003611- PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T09:39:54Z","last_updated_date":"2025-06-20T09:39:54Z","reference_number":"EMA/296527/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0251-2024-ema-decision-19-july-2024-granting-product-specific-waiver-diclofenac-sodium-thiocolchicoside-emea-003611-pip01-24_en.pdf"},
    {"id":"68854","name":"P/0272/2024: EMA decision of 24 July 2024 on the granting of a product specific waiver for acasunlimab (EMEA-003606-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T09:40:55Z","last_updated_date":"2025-06-20T09:40:55Z","reference_number":"EMA/307559/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0272-2024-ema-decision-24-july-2024-granting-product-specific-waiver-acasunlimab-emea-003606-pip01-24_en.pdf"},
    {"id":"68859","name":"P/0258/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for alvelestat (tosylate) (EMEA-003605-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T10:47:08Z","last_updated_date":"2025-06-20T10:47:08Z","reference_number":"EMA/320746/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0258-2024-ema-decision-19-july-2024-granting-product-specific-waiver-alvelestat-tosylate-emea-003605-pip01-24_en.pdf"},
    {"id":"68860","name":"P/0267/2024: EMA decision of 17 July 2024 on the granting of a product specific waiver for indapamide / ramipril (EMEA-003600-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T10:48:10Z","last_updated_date":"2025-06-20T10:48:10Z","reference_number":"EMA/328778/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0267-2024-ema-decision-17-july-2024-granting-product-specific-waiver-indapamide-ramipril-emea-003600-pip01-24_en.pdf"},
    {"id":"68861","name":"P/0270/2024: EMA decision of 17 July 2024 on the granting of a product specific waiver for trastuzumab-exatecan derivative antibody-drug conjugate (EMEA-003599-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-20T10:49:12Z","last_updated_date":"2025-06-20T10:49:12Z","reference_number":"EMA/328766/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0270-2024-ema-decision-17-july-2024-granting-product-specific-waiver-trastuzumab-exatecan-derivative-antibody-drug-conjugate-emea-003599-pip01-24_en.pdf"},
    {"id":"68733","name":"P/0164/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for giroctocogene fitelparvovec (EMEA-002724-PIP01-19-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:26:26Z","last_updated_date":"2025-06-16T15:26:26Z","reference_number":"EMA/176730/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0164-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-giroctocogene-fitelparvovec-emea-002724-pip01-19-m03_en.pdf"},
    {"id":"68732","name":"P/0152/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for loncastuximab tesirine (Zynlonta), (EMEA-002665-PIP02-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:25:38Z","last_updated_date":"2025-06-16T15:25:38Z","reference_number":"EMA/148125/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0152-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-loncastuximab-tesirine-zynlonta-emea-002665-pip02-20-m01_en.pdf"},
    {"id":"68731","name":"P/0163/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for levonogestrel (EMEA- 002474-PIP02-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:24:51Z","last_updated_date":"2025-06-16T15:24:51Z","reference_number":"EMA/176728/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0163-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-levonogestrel-emea-002474-pip02-18-m02_en.pdf"},
    {"id":"68730","name":"P/0151/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for berotralstat (Orladeyo), (EMEA-002449-PIP02-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:23:50Z","last_updated_date":"2025-06-16T15:23:50Z","reference_number":"EMA/148123/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0151-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-berotralstat-orladeyo-emea-002449-pip02-18-m02_en.pdf"},
    {"id":"68727","name":"P/0168/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for influenza vaccine (surface antigen, inactivated, prepared in cell cultures) [QIVc] (Flucelvax Tetra), (EMEA-002068- PIP01-16-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:21:07Z","last_updated_date":"2025-06-16T15:21:07Z","reference_number":"EMA/178725/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0168-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-influenza-vaccine-surface-antigen-inactivated-prepared-cell-cultures-qivc-flucelvax-tetra-emea-002068_en.pdf"},
    {"id":"68725","name":"P/0167/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed PIP for beclometasone (dipropionate) / formoterol (fumarate dihydrate) / glycopyrronium bromide (Trimbow and associated names), (EMEA-001875-PIP02-18-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:18:11Z","last_updated_date":"2025-06-16T15:18:11Z","reference_number":"EMA/178722/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0167-2024-ema-decision-6-may-2024-acceptance-modification-agreed-pip-beclometasone-dipropionate-formoterol-fumarate-dihydrate-glycopyrronium-bromide-trimbow-associated-names-emea-001875-pip02-18-m04_en.pdf"},
    {"id":"68724","name":"P/0176/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for brexucabtagene autoleucel (Tecartus), (EMEA-001862-PIP03-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:17:10Z","last_updated_date":"2025-06-16T15:17:10Z","reference_number":"EMA/178727/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0176-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-brexucabtagene-autoleucel-tecartus-emea-001862-pip03-20-m02_en.pdf"},
    {"id":"68723","name":"P/0172/2024: EMA decision of 3 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for venglustat (EMEA- 001716-PIP07-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:16:16Z","last_updated_date":"2025-06-16T15:16:16Z","reference_number":"EMA/182551/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0172-2024-ema-decision-3-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-venglustat-emea-001716-pip07-22-m01_en.pdf"},
    {"id":"68722","name":"P/0171/2024: EMA decision of 3 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for atrasentan (hydrochloride), (EMEA-001666-PIP02-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-16T15:15:24Z","last_updated_date":"2025-06-16T15:15:24Z","reference_number":"EMA/182112/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0171-2024-ema-decision-3-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-atrasentan-hydrochloride-emea-001666-pip02-21-m01_en.pdf"},
    {"id":"68660","name":"P/0162/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for atorvastatin calcium / fenofibrate (EMEA-003563- PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:57:46Z","last_updated_date":"2025-06-11T14:57:46Z","reference_number":"EMA/176537/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0162-2024-ema-decision-6-may-2024-granting-product-specific-waiver-atorvastatin-calcium-fenofibrate-emea-003563-pip01-23_en.pdf"},
    {"id":"68763","name":"P/0252/2024: EMA decision of 19 July 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of azabicycloheptane-carboxamide (EMEA-003451-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-13T17:21:11Z","last_updated_date":"2025-06-13T17:21:11Z","reference_number":"EMA/296571/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0252-2024-ema-decision-19-july-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-derivative-azabicycloheptane-carboxamide-emea-003451-pip01-23_en.pdf"},
    {"id":"68728","name":"P/0149/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for onasemnogene abeparvovec (Zolgensma), (EMEA-002168-PIP01-17-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-13T15:22:00Z","last_updated_date":"2025-06-13T15:22:00Z","reference_number":"EMA/155951/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0149-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-onasemnogene-abeparvovec-zolgensma-emea-002168-pip01-17-m06_en.pdf"},
    {"id":"68726","name":"P/0186/2024: EMA decision of 29 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid ... (EMEA-001930-PIP01-16-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-12T15:19:41Z","last_updated_date":"2025-06-12T15:19:41Z","reference_number":"EMA/246710/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0186-2024-ema-decision-29-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-neisseria-meningitidis-serogroup-polysaccharide-conjugated-tetanus-toxoid-emea-001930-pip01-16-m05_en.pdf"},
    {"id":"68729","name":"P/0148/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for olaparib (Lynparza), (EMEA-002269-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-12T15:22:56Z","last_updated_date":"2025-06-12T15:22:56Z","reference_number":"EMA/155893/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0148-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-olaparib-lynparza-emea-002269-pip01-17-m03_en.pdf"},
    {"id":"68721","name":"P/0138/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for nivolumab (Opdivo), (EMEA-001407-PIP02-15-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-12T15:14:28Z","last_updated_date":"2025-06-12T15:14:28Z","reference_number":"EMA/153114/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0138-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-nivolumab-opdivo-emea-001407-pip02-15-m07_en.pdf"},
    {"id":"68720","name":"P/0137/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for avatrombopag maleate (Doptelet), (EMEA-001136-PIP01-11-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-12T15:13:13Z","last_updated_date":"2025-06-12T15:13:13Z","reference_number":"EMA/153113/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0137-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-avatrombopag-maleate-doptelet-emea-001136-pip01-11-m03_en.pdf"},
    {"id":"68702","name":"P/0177/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for 13 Grass Aqueous Extract (EMEA-000813-PIP01-09-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:36:15Z","last_updated_date":"2025-06-11T15:36:15Z","reference_number":"EMA/105457/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0177-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-13-grass-aqueous-extract-emea-000813-pip01-09-m01_en.pdf"},
    {"id":"68701","name":"P/0135/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for apixaban (Eliquis), (EMEA-000183-PIP02-12-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:32:19Z","last_updated_date":"2025-06-11T15:32:19Z","reference_number":"EMA/153112/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0135-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-apixaban-eliquis-emea-000183-pip02-12-m05_en.pdf"},
    {"id":"68667","name":"P/0180/2024: EMA decision of 16 May 2024 on the granting of a product specific waiver for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), strain A (H3N2), strain B (Victoria lineage) (EMEA-003624-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:08:52Z","last_updated_date":"2025-06-11T15:08:52Z","reference_number":"EMA/221881/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0180-2024-ema-decision-16-may-2024-granting-product-specific-waiver-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-h1n1-strain-h3n2-strain-b-victoria-lineage-emea-003624-pip01_en.pdf"},
    {"id":"68665","name":"P/0181/2024: EMA decision of 15 May 2024 on agreement of PIP and on granting of a waiver for influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), strain A (H3N2), strain B (Victoria lineage) (EMEA-003623-PIP01-24) ","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:04:37Z","last_updated_date":"2025-06-11T15:04:37Z","reference_number":"EMA/176737/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0181-2024-ema-decision-15-may-2024-agreement-pip-granting-waiver-influenza-virus-surface-antigens-haemagglutinin-neuraminidase-strain-h1n1-strain-h3n2-strain-b-victoria-lineage-emea-003623-pip01-24_en.pdf"},
    {"id":"68664","name":"P/0143/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for pitavastatin calcium / ezetimibe, (EMEA-003573-PIP01- 23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:03:44Z","last_updated_date":"2025-06-11T15:03:44Z","reference_number":"EMA/153124/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0143-2024-ema-decision-6-may-2024-granting-product-specific-waiver-pitavastatin-calcium-ezetimibe-emea-003573-pip01-23_en.pdf"},
    {"id":"68663","name":"P/0156/2024: EMA decision of 6 May 2024 on the granting of a product-specific waiver for human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant (EMEA-003570-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:02:55Z","last_updated_date":"2025-06-11T15:02:55Z","reference_number":"EMA/148133/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0156-2024-ema-decision-6-may-2024-granting-product-specific-waiver-human-alpha-1-proteinase-inhibitor-immunoglobulin-g-fusion-protein-recombinant-emea-003570-pip01-23_en.pdf"},
    {"id":"68662","name":"P/0155/2024: EMA decision of 6 May 2024 on the granting of a product-specific waiver for Volixibat potassium (EMEA-003567-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T15:02:05Z","last_updated_date":"2025-06-11T15:02:05Z","reference_number":"EMA/148131/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0155-2024-ema-decision-6-may-2024-granting-product-specific-waiver-volixibat-potassium-emea-003567-pip01-23_en.pdf"},
    {"id":"68661","name":"P/0154/2024: EMA decision of 6 May 2024 on the granting of a product-specific waiver for camreluzimab (EMEA-003566-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:59:15Z","last_updated_date":"2025-06-11T14:59:15Z","reference_number":"EMA/148130/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0154-2024-ema-decision-6-may-2024-granting-product-specific-waiver-camreluzimab-emea-003566-pip01-23_en.pdf"},
    {"id":"68659","name":"P/0161/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for ezetimibe / fenofibrate / rosuvastatin calcium (EMEA- 003562-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:56:52Z","last_updated_date":"2025-06-11T14:56:52Z","reference_number":"EMA/176534/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0161-2024-ema-decision-6-may-2024-granting-product-specific-waiver-ezetimibe-fenofibrate-rosuvastatin-calcium-emea-003562-pip01-23_en.pdf"},
    {"id":"68658","name":"P/0160/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for carbachol / brimonidine tartrate (EMEA-003561-PIP01- 23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:55:44Z","last_updated_date":"2025-06-11T14:55:44Z","reference_number":"EMA/176533/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0160-2024-ema-decision-6-may-2024-granting-product-specific-waiver-carbachol-brimonidine-tartrate-emea-003561-pip01-23_en.pdf"},
    {"id":"68657","name":"P/0146/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for baxdrostat / dapagliflozin (propanediol monohydrate) (EMEA-003559-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:54:43Z","last_updated_date":"2025-06-11T14:54:43Z","reference_number":"EMA/155785/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0146-2024-ema-decision-6-may-2024-granting-product-specific-waiver-baxdrostat-dapagliflozin-propanediol-monohydrate-emea-003559-pip01-23_en.pdf"},
    {"id":"68656","name":"P/0147/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for petosemtamab (EMEA-003557-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:53:35Z","last_updated_date":"2025-06-11T14:53:35Z","reference_number":"EMA/155809/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0147-2024-ema-decision-6-may-2024-granting-product-specific-waiver-petosemtamab-emea-003557-pip01-23_en.pdf"},
    {"id":"68655","name":"P/0140/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for alrefimotide / tapderimotide / riletamotide, (EMEA- 003555-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:52:46Z","last_updated_date":"2025-06-11T14:52:46Z","reference_number":"EMA/153122/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0140-2024-ema-decision-6-may-2024-granting-product-specific-waiver-alrefimotide-tapderimotide-riletamotide-emea-003555-pip01-23_en.pdf"},
    {"id":"68654","name":"P/0139/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for acetylcysteine amide, (EMEA-003554-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:51:50Z","last_updated_date":"2025-06-11T14:51:50Z","reference_number":"EMA/153120/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0139-2024-ema-decision-6-may-2024-granting-product-specific-waiver-acetylcysteine-amide-emea-003554-pip01-23_en.pdf"},
    {"id":"68653","name":"P/0175/2024: EMA decision of 3 May 2024 on the agreement of a paediatric investigation plan for Human rabies immune globulin (EMEA-003552- PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:50:54Z","last_updated_date":"2025-06-11T14:50:54Z","reference_number":"EMA/182144/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2024-ema-decision-3-may-2024-agreement-paediatric-investigation-plan-human-rabies-immune-globulin-emea-003552-pip01-23_en.pdf"},
    {"id":"68652","name":"P/0174/2024: EMA decision of 3 May 2024 on the granting of a product specific waiver for N-(2-((2-(dimethylamino)ethyl)(methyl)amino)-5-((4- (1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)-6-(2,2,2-trifluoroethoxy)pyridin-3-yl)acrylamide methanesulfonate","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:49:44Z","last_updated_date":"2025-06-11T14:49:44Z","reference_number":"EMA/182137/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0174-2024-ema-decision-3-may-2024-granting-product-specific-waiver-n-2-2-dimethylaminoethylmethylamino-5-4-1-methyl-1h-indol-3-ylpyrimidin-2-ylamino-6-222-trifluoroethoxypyridin-3-ylacrylamide_en.pdf"},
    {"id":"68651","name":"P/0150/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for lutikizumab (EMEA-003481-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:46:48Z","last_updated_date":"2025-06-11T14:46:48Z","reference_number":"EMA/155839/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0150-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-lutikizumab-emea-003481-pip01-23_en.pdf"},
    {"id":"68650","name":"P/0182/2024: EMA decision of 15 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for zasocitinib (EMEA-003478-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:44:10Z","last_updated_date":"2025-06-11T14:44:10Z","reference_number":"EMA/224149/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0182-2024-ema-decision-15-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-zasocitinib-emea-003478-pip01-23_en.pdf"},
    {"id":"68649","name":"P/0142/2024: EMA decision of 6 May 2024 on the agreement of a PIP and on the granting of a deferral and on the granting of a waiver for messenger RNA encoding Cas9, single guide RNA targeting the human KLKB1 gene (NTLA-2002) (EMEA-003465-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-11T14:19:15Z","last_updated_date":"2025-06-11T14:19:15Z","reference_number":"EMA/153131/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0142-2024-ema-decision-6-may-2024-agreement-pip-granting-deferral-granting-waiver-messenger-rna-encoding-cas9-single-guide-rna-targeting-human-klkb1-gene-ntla-2002-emea-003465-pip01-23_en.pdf"},
    {"id":"68648","name":"P/0159/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for laruparetigene zovaparvovec (EMEA-003457-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T14:18:17Z","last_updated_date":"2025-06-10T14:18:17Z","reference_number":"EMA/170634/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0159-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-laruparetigene-zovaparvovec-emea-003457-pip01-23_en.pdf"},
    {"id":"68646","name":"P/0184/2024 : EMA decision of 17 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mometasone furoate (EMEA-003454-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T14:17:27Z","last_updated_date":"2025-06-10T14:17:27Z","reference_number":"EMA/226770/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0184-2024-ema-decision-17-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mometasone-furoate-emea-003454-pip01-23_en.pdf"},
    {"id":"68645","name":"P/0173/2024: EMA decision of 3 May 2024 on the granting of a product specific waiver for modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/mRNA-4157), (EMEA-003434-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T14:16:21Z","last_updated_date":"2025-06-10T14:16:21Z","reference_number":"EMA/182128/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0173-2024-ema-decision-3-may-2024-granting-product-specific-waiver-modified-messenger-ribonucleic-acid-encoding-individual-patient-specific-tumour-neoantigens-v940-mrna-4157-emea-003434-pip02-23_en.pdf"},
    {"id":"68599","name":"P/0136/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for clostridium botulinum neurotoxin type A (150 kD), free from complexing proteins (Xeomin, Bocouture), (EMEA-001039-PIP04-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T09:24:48Z","last_updated_date":"2025-06-06T09:24:48Z","reference_number":"EMA/153118/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0136-2024-ema-decision-6-may-2024-granting-product-specific-waiver-clostridium-botulinum-neurotoxin-type-150-kd-free-complexing-proteins-xeomin-bocouture-emea-001039-pip04-23_en.pdf"},
    {"id":"68600","name":"P/0145/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for erdafitinib (EMEA-002042-PIP03-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T09:42:46Z","last_updated_date":"2025-06-06T09:42:46Z","reference_number":"EMA/155774/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0145-2024-ema-decision-6-may-2024-granting-product-specific-waiver-erdafitinib-emea-002042-pip03-23_en.pdf"},
    {"id":"68601","name":"P/0183/2024: EMA decision of 17 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ganaxolone (ZTALMY), (EMEA-002341-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T09:44:07Z","last_updated_date":"2025-06-06T09:44:07Z","reference_number":"EMA/226610/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0183-2024-ema-decision-17-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ganaxolone-ztalmy-emea-002341-pip02-23_en.pdf"},
    {"id":"68606","name":"P/0157/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for spesolimab (Spevigo), (EMEA-002475-PIP04-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T09:44:59Z","last_updated_date":"2025-06-06T09:44:59Z","reference_number":"EMA/170629/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0157-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-spesolimab-spevigo-emea-002475-pip04-23_en.pdf"},
    {"id":"68616","name":"P/0185/2024: EMA decision of 23 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mavorixafor (EMEA-002490-PIP01-18)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T16:43:50Z","last_updated_date":"2025-06-06T16:43:50Z","reference_number":"EMA/243653/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0185-2024-ema-decision-23-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mavorixafor-emea-002490-pip01-18_en.pdf"},
    {"id":"68617","name":"P/0166/2024: EMA decision of 6 May 2024 on the granting of a product specific waiver for amivantamab (Rybrevant), (EMEA-002573-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T16:45:09Z","last_updated_date":"2025-06-06T16:45:09Z","reference_number":"EMA/178740/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0166-2024-ema-decision-6-may-2024-granting-product-specific-waiver-amivantamab-rybrevant-emea-002573-pip02-23_en.pdf"},
    {"id":"68618","name":"P/0169/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for nivolumab / relatlimab (Opdualag), (EMEA-002727-PIP03-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T16:46:49Z","last_updated_date":"2025-06-06T16:46:49Z","reference_number":"EMA/178738/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0169-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-waiver-nivolumab-relatlimab-opdualag-emea-002727-pip03-23_en.pdf"},
    {"id":"68619","name":"P/0158/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for etavopivat (EMEA-002924-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-06T16:50:16Z","last_updated_date":"2025-06-06T16:50:16Z","reference_number":"EMA/170630/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0158-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-etavopivat-emea-002924-pip02-23_en.pdf"},
    {"id":"68620","name":"P/0153/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for live attenuated respiratory syncytial virus (RSV) (EMEA-003277-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T16:51:15Z","last_updated_date":"2025-06-10T16:51:15Z","reference_number":"EMA/148126/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0153-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-live-attenuated-respiratory-syncytial-virus-rsv-emea-003277-pip02-23_en.pdf"},
    {"id":"68621","name":"P/0178/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for orforglipron, (EMEA-003299-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T16:52:20Z","last_updated_date":"2025-06-10T16:52:20Z","reference_number":"EMA/105471/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0178-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-orforglipron-emea-003299-pip01-22_en.pdf"},
    {"id":"68622","name":"P/0141/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for hemopexin, human, (EMEA-003333-PIP01-22)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T16:53:06Z","last_updated_date":"2025-06-10T16:53:06Z","reference_number":"EMA/153127/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0141-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-hemopexin-human-emea-003333-pip01-22_en.pdf"},
    {"id":"68624","name":"P/0170/2024: EMA decision of 6 May 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tanimilast (EMEA-003393-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T16:54:44Z","last_updated_date":"2025-06-10T16:54:44Z","reference_number":"EMA/178739/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0170-2024-ema-decision-6-may-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tanimilast-emea-003393-pip01-23_en.pdf"},
    {"id":"63890","name":"P/0055/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for givinostat (EMEA- 000551-PIP04-21-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-02T11:34:59Z","last_updated_date":"2025-04-02T11:34:59Z","reference_number":"EMA/62604/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0055-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-givinostat-emea-000551-pip04-21-m03_en.pdf"},
    {"id":"48477","name":"P/0002/2024 : EMA decision of 3 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mozafancogene autotemcel, (EMEA-002578-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-14T11:53:00Z","last_updated_date":"2025-03-14T11:53:00Z","reference_number":"EMA/879/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0002-2024-ema-decision-3-january-2024-acceptance-modification-agreed-paediatric-investigation-plan-mozafancogene-autotemcel-emea-002578-pip01-19-m01_en.pdf"},
    {"id":"64219","name":"P/0018/2024 : EMA decision of 31 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (EMEA- 001949-PIP02-18-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-14T12:20:02Z","last_updated_date":"2025-03-14T12:20:02Z","reference_number":"EMA/12676/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0018-2024-ema-decision-31-january-2024-acceptance-modification-agreed-paediatric-investigation-plan-gadopiclenol-emea-001949-pip02-18-m04_en.pdf"},
    {"id":"64218","name":"P/0013/2024 : EMA decision of 31 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (EMEA- 001949-PIP01-16-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-14T10:57:00Z","last_updated_date":"2025-03-14T10:57:00Z","reference_number":"EMA/12591/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0013-2024-ema-decision-31-january-2024-acceptance-modification-agreed-paediatric-investigation-plan-gadopiclenol-emea-001949-pip01-16-m06_en.pdf"},
    {"id":"63924","name":"P/0012/2024 : EMA decision of 31 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tralokinumab (Adtralza), (EMEA-001900-PIP02-17-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-14T10:44:57Z","last_updated_date":"2025-03-14T10:44:57Z","reference_number":"EMA/15339/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0012-2024-ema-decision-31-january-2024-acceptance-modification-agreed-paediatric-investigation-plan-tralokinumab-adtralza-emea-001900-pip02-17-m08_en.pdf"},
    {"id":"63921","name":"P/0010/2024 : EMA decision of 31 January 2024 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-07-05T14:48:56Z","last_updated_date":"2024-07-05T14:48:56Z","reference_number":"EMA/11085/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0010-2024-ema-decision-31-january-2024-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-rinvoq-emea-001741-pip01-14-m07_en.pdf"},
    {"id":"52237","name":"P/0028/2024 : EMA decision of 29 January 2024 on the refusal of a modification of an agreed paediatric investigation plan and on the granting of a product-specific waiver for tocilizumab (RoActemra), (EMEA-000309-PIP07-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2021-08-19T15:07:00Z","last_updated_date":"2025-03-12T16:48:00Z","reference_number":"EMA/29054/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0028-2024-ema-decision-29-january-2024-refusal-modification-agreed-paediatric-investigation-plan-granting-product-specific-waiver-tocilizumab-roactemra-emea-000309-pip07-21-m01_en.pdf"},
    {"id":"66814","name":"P/0475/2023 : EMA decision of 1 Dec 2023 on the granting of a product specific waiver for humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker (SGN B6A) (EMEA-003471-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T09:40:31Z","last_updated_date":"2025-02-17T09:40:31Z","reference_number":"EMA/498422/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0475-2023-ema-decision-1-dec-2023-granting-product-specific-waiver-humanised-igg1-monoclonal-antibody-against-integrin-beta-6-conjugated-monomethyl-auristatin-e-valine-citrulline-linker-sgn-b6a-emea_en.pdf"},
    {"id":"66815","name":"P/0490/2023 : EMA decision of 1 December 2023 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-003472-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T09:41:52Z","last_updated_date":"2025-02-17T09:41:52Z","reference_number":"EMA/530028/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0490-2023-ema-decision-1-december-2023-granting-product-specific-waiver-rosuvastatin-ezetimibe-emea-003472-pip01-23_en.pdf"},
    {"id":"66813","name":"P/0491/2023 : EMA decision of 1 December 2023 on the granting of a product specific waiver for ilginatinib maleate, (EMEA-003468-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T09:39:18Z","last_updated_date":"2025-02-17T09:39:18Z","reference_number":"EMA/517388/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0491-2023-ema-decision-1-december-2023-granting-product-specific-waiver-ilginatinib-maleate-emea-003468-pip01-23_en.pdf"},
    {"id":"66812","name":"P/0481/2023 : EMA decision of 1 December 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for decitabine / tetrahydrouridine (EMEA-003404-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-17T09:37:31Z","last_updated_date":"2025-02-17T09:37:31Z","reference_number":"EMA/498578/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0481-2023-ema-decision-1-december-2023-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-decitabine-tetrahydrouridine-emea-003404-pip01-23_en.pdf"},
    {"id":"66796","name":"P/0485/2023 : EMA decision of 1 December 2023 on the acceptance of a modification of an agreed paediatric investigation plan for zanamivir (Relenza), (EMEA-001318-PIP01-12-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-02-14T16:17:36Z","last_updated_date":"2025-02-14T16:17:36Z","reference_number":"EMA/517349/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0485-2023-ema-decision-1-december-2023-acceptance-modification-agreed-paediatric-investigation-plan-zanamivir-relenza-emea-001318-pip01-12-m05_en.pdf"},
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    {"id":"68889","name":"P/0233/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene (EMEA-003593-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-23T17:37:08Z","last_updated_date":"2025-06-23T17:37:08Z","reference_number":"EMA/321024/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0233-2024-ema-decision-19-july-2024-granting-product-specific-waiver-autologous-cd3-positive-t-cells-transduced-retroviral-vector-containing-anti-b-cell-maturation-agent-chimeric-antigen-receptor_en.pdf"},
    {"id":"68890","name":"P/0234/2024: EMA decision of 18 July 2024 on the granting of a product specific waiver for autologous CD3-positive T cells transduced with a retroviral vector containing an anti-B cell maturation agent chimeric antigen receptor gene (EMEA-003593-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-23T17:42:22Z","last_updated_date":"2025-06-23T17:42:22Z","reference_number":"EMA/320747/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0234-2024-ema-decision-18-july-2024-granting-product-specific-waiver-autologous-cd3-positive-t-cells-transduced-retroviral-vector-containing-anti-b-cell-maturation-agent-chimeric-antigen-receptor_en.pdf"},
    {"id":"68891","name":"P/0231/2024: EMA decision of 19 July 2024 on the granting of a product-specific waiver for fulzerasib (EMEA-003594-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-23T17:43:37Z","last_updated_date":"2025-06-23T17:43:37Z","reference_number":"EMA/291608/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0231-2024-ema-decision-19-july-2024-granting-product-specific-waiver-fulzerasib-emea-003594-pip01-24_en.pdf"},
    {"id":"68892","name":"P/0232/2024: EMA decision of 19 July 2024 on the granting of a product-specific waiver for (EMEA-003596-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T17:44:31Z","last_updated_date":"2025-06-24T17:44:31Z","reference_number":"EMA/291622/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0232-2024-ema-decision-19-july-2024-granting-product-specific-waiver-emea-003596-pip01-24_en.pdf"},
    {"id":"68893","name":"P/0257/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for (EMEA-003597-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T17:45:46Z","last_updated_date":"2025-06-24T17:45:46Z","reference_number":"EMA/296468/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0257-2024-ema-decision-19-july-2024-granting-product-specific-waiver-emea-003597-pip01-24_en.pdf"},
    {"id":"68894","name":"P/0256/2024: EMA decision of 19 July 2024 on the granting of a product specific waiver for anti-human LAG-3 monoclonal antibody, human IgG4 isotype (EMEA-003598-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T17:47:09Z","last_updated_date":"2025-06-24T17:47:09Z","reference_number":"EMA/296479/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0256-2024-ema-decision-19-july-2024-granting-product-specific-waiver-anti-human-lag-3-monoclonal-antibody-human-igg4-isotype-emea-003598-pip01-24_en.pdf"},
    {"id":"68907","name":"P/0225/2024: EMA decision of 5 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for setrusumab (EMEA-002169-PIP01-17-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:42:58Z","last_updated_date":"2025-06-24T12:42:58Z","reference_number":"EMA/291519/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0225-2024-ema-decision-5-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-setrusumab-emea-002169-pip01-17-m03_en.pdf"},
    {"id":"68905","name":"P/0227/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mexiletine (hydrochloride) (Namuscla), (EMEA-002012-PIP01-16-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:40:50Z","last_updated_date":"2025-06-24T12:40:50Z","reference_number":"EMA/291493/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-mexiletine-hydrochloride-namuscla-emea-002012-pip01-16-m05_en.pdf"},
    {"id":"68906","name":"P/0228/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for rAAV8 viral vector encoding the human UGT1A1 transgene (rAAV8-hUGT1A1) (EMEA-002021-PIP01-16-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:41:52Z","last_updated_date":"2025-06-24T12:41:52Z","reference_number":"EMA/291508/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0228-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-raav8-viral-vector-encoding-human-ugt1a1-transgene-raav8-hugt1a1-emea-002021-pip01-16-m01_en.pdf"},
    {"id":"68908","name":"P/0229/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for niraparib (tosylate monohydrate) (Zejula), (EMEA-002268-PIP02-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:43:49Z","last_updated_date":"2025-06-24T12:43:49Z","reference_number":"EMA/291561/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0229-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-niraparib-tosylate-monohydrate-zejula-emea-002268-pip02-18-m02_en.pdf"},
    {"id":"68909","name":"P/0230/2024: EMA decision of 9 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ralinepag (EMEA-002432-PIP02-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:45:12Z","last_updated_date":"2025-06-24T12:45:12Z","reference_number":"EMA/291603/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0230-2024-ema-decision-9-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-ralinepag-emea-002432-pip02-20-m01_en.pdf"},
    {"id":"68902","name":"P/0235/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (Reagila), (EMEA-001652-PIP01-14-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:35:50Z","last_updated_date":"2025-06-24T12:35:50Z","reference_number":"EMA/320584/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0235-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-cariprazine-hydrochloride-reagila-emea-001652-pip01-14-m06_en.pdf"},
    {"id":"68901","name":"P/0236/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vonicog alfa (Veyvondi), (EMEA-001164-PIP01-11-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:34:49Z","last_updated_date":"2025-06-24T12:34:49Z","reference_number":"EMA/320605/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0236-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-vonicog-alfa-veyvondi-emea-001164-pip01-11-m08_en.pdf"},
    {"id":"68895","name":"P/0238/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for regadenoson (Rapiscan), (EMEA-000410-PIP01-08-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T09:53:27Z","last_updated_date":"2025-06-24T09:53:27Z","reference_number":"EMA/319202/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0238-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-regadenoson-rapiscan-emea-000410-pip01-08-m07_en.pdf"},
    {"id":"68896","name":"P/0239/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tofacitinib (Xeljanz), (EMEA-000576-PIP01-09-M16)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T09:54:18Z","last_updated_date":"2025-06-24T09:54:18Z","reference_number":"EMA/319201/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0239-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-tofacitinib-xeljanz-emea-000576-pip01-09-m16_en.pdf"},
    {"id":"68911","name":"P/0240/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ibrexafungerp, (EMEA-002535-PIP03-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:47:34Z","last_updated_date":"2025-06-24T12:47:34Z","reference_number":"EMA/322324/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0240-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-ibrexafungerp-emea-002535-pip03-19-m01_en.pdf"},
    {"id":"68904","name":"P/0241/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pegvaliase (Palynziq), (EMEA-001951-PIP01-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:39:48Z","last_updated_date":"2025-06-24T12:39:48Z","reference_number":"EMA/298061/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0241-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-pegvaliase-palynziq-emea-001951-pip01-16-m03_en.pdf"},
    {"id":"68920","name":"P/0253/2024: EMA decision of 19 July 2024 on  acceptance of a modification of an agreed PIP for SARS-CoV-2 virus recombinant spike protein receptor binding domain fusion homodimer ... (Bimervax), (EMEA-003191-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T13:01:28Z","last_updated_date":"2025-06-24T13:01:28Z","reference_number":"EMA/296812/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0253-2024-ema-decision-19-july-2024-acceptance-modification-agreed-pip-sars-cov-2-virus-recombinant-spike-protein-receptor-binding-domain-fusion-homodimer-bimervax-emea-003191-pip01-22-m01_en.pdf"},
    {"id":"68917","name":"P/0255/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed PIP for severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (Nuvaxovid), (EMEA-002941-PIP01-20-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:59:14Z","last_updated_date":"2025-06-24T12:59:14Z","reference_number":"EMA/296650/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0255-2024-ema-decision-19-july-2024-acceptance-modification-agreed-pip-severe-acute-respiratory-syndrome-coronavirus-2-recombinant-spike-protein-nanoparticle-vaccine-matrix-m1-adjuvant-nuvaxovid_en.pdf"},
    {"id":"68900","name":"P/0248/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus / dermatophagoides farinae extracts (50%/50%), (EMEA-000836-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:32:00Z","last_updated_date":"2025-06-24T12:32:00Z","reference_number":"EMA/319197/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0248-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-dermatophagoides-pteronyssinus-dermatophagoides-farinae-extracts-50-50-emea-000836-pip01-10-m01_en.pdf"},
    {"id":"68903","name":"P/0243/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir / lamivudine (Dovato), (EMEA-001940-PIP01-16-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:36:57Z","last_updated_date":"2025-06-24T12:36:57Z","reference_number":"EMA/297553/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0243-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-dolutegravir-lamivudine-dovato-emea-001940-pip01-16-m06_en.pdf"},
    {"id":"68897","name":"P/0244/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vedolizumab (Entyvio), (EMEA-000645-PIP01-09-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T09:55:26Z","last_updated_date":"2025-06-24T09:55:26Z","reference_number":"EMA/319200/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0244-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-vedolizumab-entyvio-emea-000645-pip01-09-m09_en.pdf"},
    {"id":"68898","name":"P/0245/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides farinae extracts 100 %, (EMEA-000834-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T09:56:29Z","last_updated_date":"2025-06-24T09:56:29Z","reference_number":"EMA/319199/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0245-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-dermatophagoides-farinae-extracts-100-emea-000834-pip01-10-m01_en.pdf"},
    {"id":"68918","name":"P/0246/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for donidalorsen, (EMEA- 003112-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T13:00:20Z","last_updated_date":"2025-06-24T13:00:20Z","reference_number":"EMA/324334/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0246-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-donidalorsen-emea-003112-pip01-21-m01_en.pdf"},
    {"id":"68939","name":"Event report - Advancing regulatory science research","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-24T16:16:09Z","last_updated_date":"2025-06-24T16:16:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/event-report-advancing-regulatory-science-research_en.pdf"},
    {"id":"68899","name":"P/0247/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dermatophagoides pteronyssinus extracts 100%, (EMEA-000835-PIP01-10-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:29:37Z","last_updated_date":"2025-06-24T12:29:37Z","reference_number":"EMA/319198/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0247-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-dermatophagoides-pteronyssinus-extracts-100-emea-000835-pip01-10-m01_en.pdf"},
    {"id":"68921","name":"P/0249/2024: EMA decision of 18 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gefurulimab (EMEA-003302-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T13:04:17Z","last_updated_date":"2025-06-24T13:04:17Z","reference_number":"EMA/319196/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0249-2024-ema-decision-18-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-gefurulimab-emea-003302-pip01-22-m01_en.pdf"},
    {"id":"68916","name":"P/0254/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ublituximab (Briumvi), (EMEA-002889-PIP02-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:57:19Z","last_updated_date":"2025-06-24T12:57:19Z","reference_number":"EMA/296721/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0254-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-ublituximab-briumvi-emea-002889-pip02-20-m01_en.pdf"},
    {"id":"68910","name":"P/0260/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dostarlimab (Jemperli), (EMEA-002463-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:46:21Z","last_updated_date":"2025-06-24T12:46:21Z","reference_number":"EMA/328795/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0260-2024-ema-decision-17-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-dostarlimab-jemperli-emea-002463-pip01-18-m02_en.pdf"},
    {"id":"68914","name":"P/0266/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ribociclib (Kisqali), (EMEA-002765-PIP02-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:53:37Z","last_updated_date":"2025-06-24T12:53:37Z","reference_number":"EMA/328854/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0266-2024-ema-decision-17-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-ribociclib-kisqali-emea-002765-pip02-21-m01_en.pdf"},
    {"id":"68912","name":"P/0268/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for doravirine / islatravir (EMEA-002707-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:48:36Z","last_updated_date":"2025-06-24T12:48:36Z","reference_number":"EMA/328837/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0268-2024-ema-decision-17-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-doravirine-islatravir-emea-002707-pip01-19-m02_en.pdf"},
    {"id":"68915","name":"P/0269/2024: EMA decision of 17 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for botaretigene sparoparvovec (EMEA-002827-PIP01-20-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:56:11Z","last_updated_date":"2025-06-24T12:56:11Z","reference_number":"EMA/328869/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0269-2024-ema-decision-17-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-botaretigene-sparoparvovec-emea-002827-pip01-20-m03_en.pdf"},
    {"id":"68913","name":"P/0271/2024: EMA decision of 19 July 2024 on the acceptance of a modification of an agreed paediatric investigation plan for lenacapavir sodium (Sunleca), (EMEA-002740-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T12:50:41Z","last_updated_date":"2025-06-24T12:50:41Z","reference_number":"EMA/307434/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0271-2024-ema-decision-19-july-2024-acceptance-modification-agreed-paediatric-investigation-plan-lenacapavir-sodium-sunleca-emea-002740-pip01-19-m01_en.pdf"},
    {"id":"68954","name":"P/0187/2024 - EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mecasermin rinfabate (EMEA-000534-PIP03-17-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T11:10:17Z","last_updated_date":"2025-06-25T11:10:17Z","reference_number":"EMA/251730/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0187-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-mecasermin-rinfabate-emea-000534-pip03-17-m01_en.pdf"},
    {"id":"68955","name":"P/0189/2024 - EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ertugliflozin (Steglatro), (EMEA-001533-PIP01-13-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T11:15:40Z","last_updated_date":"2025-06-25T11:15:40Z","reference_number":"EMA/251732/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0189-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-ertugliflozin-steglatro-emea-001533-pip01-13-m03_en.pdf"},
    {"id":"68956","name":"P/0191/2024 - EMA decision of 14 June 2024 on the granting of a product specific waiver for rivoceranib (Tulvegio), (EMEA-002489-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T11:26:20Z","last_updated_date":"2025-06-25T11:26:20Z","reference_number":"EMA/251752/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0191-2024-ema-decision-14-june-2024-granting-product-specific-waiver-rivoceranib-tulvegio-emea-002489-pip02-24_en.pdf"},
    {"id":"68957","name":"P/0190/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for imipenem (monohydrate) / cilastatin (sodium) / relebactam (MK-7655A) (Recarbrio), (EMEA-001809-PIP01-15- M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T11:34:21Z","last_updated_date":"2025-06-25T11:34:21Z","reference_number":"EMA/251740/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0190-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-imipenem-monohydrate-cilastatin-sodium-relebactam-mk-7655a-recarbrio-emea-001809-pip01-15-m05_en.pdf"},
    {"id":"68958","name":"P/0192/2024 - EMA decision of 14 June 2024 on the granting of a product specific waiver for telisotuzumab conjugated to (2S)-2-(2- bromoacetamido)-N-[(2S)-1-({3-[(7S)-7-ethyl-7-hydroxy-8,11-dioxo-7,8,11,13-tetrahydro-2H,10H- [1,3]dioxolo[4,5-g]pyrano...","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T11:43:49Z","last_updated_date":"2025-06-25T11:43:49Z","reference_number":"EMA/251757/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0192-2024-ema-decision-14-june-2024-granting-product-specific-waiver-telisotuzumab-conjugated-2s-2-2-bromoacetamido-n-2s-1-3-7s-7-ethyl-7-hydroxy-811-dioxo-781113-tetrahydro-2h10h-13dioxolo45_en.pdf"},
    {"id":"68959","name":"P/0193/2024 - EMA decision of 14 June 2024 on the granting of a product specific waiver for actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido- Lys-OH) (EMEA..","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T11:56:08Z","last_updated_date":"2025-06-25T11:56:08Z","reference_number":"EMA/251758/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0193-2024-ema-decision-14-june-2024-granting-product-specific-waiver-actinium-225-2-4710-tris-carboxymethyl-14710-tetraaza-cyclododec-1-yl-pentanedioic-acid-3-iodo-d-tyr-d-phe-d-lys-oh-8-oyl-e-ho_en.pdf"},
    {"id":"68962","name":"Minutes of the CVMP meeting 5-7 November 2024","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T15:31:59Z","last_updated_date":"2025-06-25T15:31:59Z","reference_number":"EMA/CVMP/197226/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cvmp-meeting-5-7-november-2024_en.pdf"},
    {"id":"68963","name":"Minutes of the CVMP meeting 8-9 April 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-06-25T15:35:21Z","last_updated_date":"2025-06-25T15:35:21Z","reference_number":"EMA/CVMP/198789/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cvmp-meeting-8-9-april-2025_en.pdf"},
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    {"id":"68974","name":"CTIS newsflash – 24 June 2025","type":"newsletter","status":"unknown","consultation_date":"","first_published_date":"2025-06-25T17:28:17Z","last_updated_date":"2025-06-25T17:28:17Z","reference_number":"EMA/198062/2025","document_url":"https://www.ema.europa.eu/en/documents/newsletter/ctis-newsflash-24-june-2025_en.pdf"},
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    {"id":"68981","name":"P/0197/2024: EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the refusal of a deferral and on the granting of a waiver for radiprodil (EMEA-003462-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T09:39:17Z","last_updated_date":"2025-06-26T09:39:17Z","reference_number":"EMA/257454/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0197-2024-ema-decision-13-june-2024-agreement-paediatric-investigation-plan-refusal-deferral-granting-waiver-radiprodil-emea-003462-pip01-23_en.pdf"},
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    {"id":"69028","name":"PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC meeting","type":"prac-recommendation","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T09:47:28Z","last_updated_date":"2025-06-30T09:47:28Z","reference_number":"EMA/PRAC/179172/2025","document_url":"https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-2-5-june-2025-prac-meeting_en.pdf"},
    {"id":"69030","name":"Questions and answers - System demo Q2 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-30T09:57:00Z","last_updated_date":"2025-06-30T09:57:00Z","reference_number":"EMA/215795/2025","document_url":"https://www.ema.europa.eu/en/documents/other/questions-answers-system-demo-q2-2025_en.pdf"},
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    {"id":"7108","name":"Draft repaglinide tablets 0.5, 1 and 2 mg product-specific bioequivalence guidance - Rev.1","type":"scientific-guideline","status":"Draft","consultation_date":"","first_published_date":"2016-05-25T02:00:00Z","last_updated_date":"2016-05-25T02:00:00Z","reference_number":"EMA/CHMP/675842/2014 ","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-repaglinide-tablets-05-1-2-mg-product-specific-bioequivalence-guidance-rev1_en.pdf"},
    {"id":"69034","name":"Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 3","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T10:31:34Z","last_updated_date":"2025-06-30T10:31:34Z","reference_number":"EMA/CHMP/315234/2014 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/tadalafil-film-coated-tablets-25-mg-5-mg-10-mg-20-mg-product-specific-bioequivalence-guidance-revision-3_en.pdf"},
    {"id":"69033","name":"Repaglinide tablets 0.5, 1 and 2 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T10:21:45Z","last_updated_date":"2025-06-30T10:21:45Z","reference_number":"CHMP/PKWP/EMA/123579/2025 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/repaglinide-tablets-05-1-2-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"69035","name":"Annual list of contracts 2024","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-30T10:36:46Z","last_updated_date":"2025-06-30T10:36:46Z","reference_number":"EMA/34081/2024","document_url":"https://www.ema.europa.eu/en/documents/other/annual-list-contracts-2024_en.pdf"},
    {"id":"69036","name":"Voriconazole tablets 50, 200 mg and powder for oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T10:49:06Z","last_updated_date":"2025-06-30T10:49:06Z","reference_number":"EMA/123572/2025 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/voriconazole-tablets-50-200-mg-powder-oral-suspension-40-mg-ml-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"69041","name":"Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T11:14:33Z","last_updated_date":"2025-06-30T11:14:33Z","reference_number":"EMA/CHMP/512475/2020 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/acenocoumarol-tablet-1-mg-4-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"69042","name":"Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T11:42:37Z","last_updated_date":"2025-06-30T11:42:37Z","reference_number":"EMA/151689/2025 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/apixaban-film-coated-tablet-25-5-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"69045","name":"Programme - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-30T13:02:40Z","last_updated_date":"2025-06-30T13:02:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-extended-eudravigilance-medicinal-product-dictionary-xevmpd-training-course-sponsors-2025_en.pdf-0"},
    {"id":"69003","name":"Real-world evidence framework to support EU regulatory decision-making: 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-06-30T14:05:20Z","last_updated_date":"2025-06-30T14:05:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/real-world-evidence-framework-support-eu-regulatory-decision-making-3rd-report-experience-gained-regulator-led-studies-february-2024-february-2025_en.pdf"},
    {"id":"69004","name":"Infosheet: EMA review of real-world data studies from September 2021 to February 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-30T14:06:09Z","last_updated_date":"2025-06-30T14:06:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/infosheet-ema-review-real-world-data-studies-september-2021-february-2025_en.pdf"},
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    {"id":"69051","name":"Dabigatran etexilate hard capsule 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T14:52:52Z","last_updated_date":"2025-06-30T14:52:52Z","reference_number":"EMA/151692/2025 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/dabigatran-etexilate-hard-capsule-75-mg-110-mg-150-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"59048","name":"Draft metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-06-22 - 2023-09-30","first_published_date":"2023-06-22T17:17:00Z","last_updated_date":"2023-06-22T17:17:00Z","reference_number":"EMA/CHMP/591346/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-metformin-immediate-release-film-coated-tablets-500-850-1000-mg-product-specific-bioequivalence-guidance_en.pdf"},
    {"id":"69052","name":"Metformin immediate-release film-coated tablets 500, 850 and 1000 mg and 1000 mg/5ml oral solution product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-06-30T14:56:34Z","last_updated_date":"2025-06-30T14:56:34Z","reference_number":"EMA/CHMP/591346/2022 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/metformin-immediate-release-film-coated-tablets-500-850-1000-mg-1000-mg-5ml-oral-solution-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
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    {"id":"68670","name":"Minutes of the COMP meeting 14-15 April 2025","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-06-10T15:40:19Z","last_updated_date":"2025-06-10T15:40:19Z","reference_number":"EMA/COMP/144968/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-comp-meeting-14-15-april-2025_en.xlsx"},
    {"id":"69070","name":"Minutes of the COMP meeting 13-15 May 2025","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-07-01T15:54:43Z","last_updated_date":"2025-07-01T15:54:43Z","reference_number":"EMA/COMP/187294/2025\t","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-comp-meeting-13-15-may-2025_en.xlsx"},
    {"id":"69071","name":"Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-07-01T16:24:23Z","last_updated_date":"2025-07-01T16:24:23Z","reference_number":"EMA/123366/2025 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/levothyroxine-tablets-125-mcg-25-mcg-50-mcg-75-mcg-100-mcg-200-mcg-additional-strengths-within-range-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"69072","name":"Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-07-01T16:28:23Z","last_updated_date":"2025-07-01T16:28:23Z","reference_number":"EMA/226629/2020 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/dolutegravir-film-coated-tablets-10-mg-25-mg-50-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
    {"id":"69073","name":"Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-07-01T16:31:08Z","last_updated_date":"2025-07-01T16:31:08Z","reference_number":"EMA/122751/2025 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ibuprofen-oral-use-immediate-release-formulations-200-800-mg-product-specific-bioequivalence-guidance-revision-2_en.pdf"},
    {"id":"69074","name":"Presentation - European shortages monitoring platform (ESMP): updates and question and answer clinic for marketing authorisation holders","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-01T17:40:00Z","last_updated_date":"2025-07-01T17:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-shortages-monitoring-platform-esmp-updates-question-answer-clinic-marketing-authorisation-holders_en.pdf"},
    {"id":"23064","name":"ICH M4Q: Location issues for common technical document for the registration of pharmaceuticals for human use - Quality - questions and answers - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-08-01T02:00:00Z","last_updated_date":"2003-08-01T02:00:00Z","reference_number":"CPMP/ICH/4680/02","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m4q-location-issues-common-technical-document-registration-pharmaceuticals-human-use-quality-questions-answers-step-5_en.pdf"},
    {"id":"30883","name":"ICH M4Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2003-07-01T02:00:00Z","last_updated_date":"2003-07-01T02:00:00Z","reference_number":"CPMP/ICH/2887/99","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m4q-common-technical-document-registration-pharmaceuticals-human-use-quality-step-5_en.pdf"},
    {"id":"64335","name":"Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products - Rev.16","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-07-26T10:27:37Z","last_updated_date":"2025-07-03T09:15:00Z","reference_number":"EMA/CVMP/PhVWP/10418/2009 Rev.16","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/combined-veterinary-dictionary-drug-regulatory-activities-veddra-list-clinical-terms-reporting-suspected-adverse-events-animals-humans-veterinary-medicinal-products-rev16_en.pdf"},
    {"id":"69089","name":"Presentation - Actions arising from previous meeting and other updates (M. Filancia, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:07:30Z","last_updated_date":"2025-07-03T14:07:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-actions-arising-previous-meeting-other-updates-m-filancia-ema_en.pdf"},
    {"id":"69091","name":"Presentation - Medical device expert panels: support to innovation (M. Antunes, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:13:08Z","last_updated_date":"2025-07-03T14:13:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medical-device-expert-panels-support-innovation-m-antunes-ema_en.pdf"},
    {"id":"69093","name":"Presentation - Information ecosystem management & building trust on vaccines (S. Labbe and R. Gonzalez-Quevedo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:23:06Z","last_updated_date":"2025-07-03T14:23:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-information-ecosystem-management-building-trust-vaccines-s-labbe-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"69090","name":"Presentation - Advancing product master data – next steps : strategic recommendations on PMS implementation","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:10:30Z","last_updated_date":"2025-07-03T14:10:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-advancing-product-master-data-next-steps-strategic-recommendations-pms-implementation_en.pdf"},
    {"id":"69092","name":"Presentation - Regulatory/ HTA interface under the HTAR: update on implementation activities (M. Berntgen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:16:26Z","last_updated_date":"2025-07-03T14:16:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-hta-interface-under-htar-update-implementation-activities-m-berntgen-ema_en.pdf"},
    {"id":"69095","name":"Presentation - EMA/HMA European platform for regulatory science research (L. Barbier and R. Herold, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:28:34Z","last_updated_date":"2025-07-03T14:28:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-hma-european-platform-regulatory-science-research-l-barbier-r-herold-ema_en.pdf"},
    {"id":"69094","name":"Presentation - Patient experience data in development programs and regulatory decision-making (R. Gonzalez-Quevedo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-03T14:26:29Z","last_updated_date":"2025-07-03T14:26:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-experience-data-development-programs-regulatory-decision-making-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"68718","name":"Agenda - Eighth EMA-EFPIA bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-12T14:13:37Z","last_updated_date":"2025-07-04T11:45:26Z","reference_number":"EMA/169565/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-eighth-ema-efpia-bilateral-meeting_en.pdf"},
    {"id":"67985","name":"CHMP summary of positive opinion for Oczyesa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-04-25T16:00:00Z","last_updated_date":"2025-04-25T16:00:00Z","reference_number":"EMA/CHMP/132414/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-oczyesa_en.pdf"},
    {"id":"69099","name":"Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products to address anti-D immunoglobulin supply chain vulnerabilities","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-04T13:49:49Z","last_updated_date":"2025-07-04T13:49:49Z","reference_number":"EMA/135603/2025","document_url":"https://www.ema.europa.eu/en/documents/other/recommendations-executive-steering-group-shortages-safety-medicinal-products-address-anti-d-immunoglobulin-supply-chain-vulnerabilities_en.pdf"},
    {"id":"67032","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Rilonacept FGK Representative Service GmbH (rilonacept)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-02-28T12:01:05Z","last_updated_date":"2025-07-04T16:00:00Z","reference_number":"EMA/64310/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-rilonacept-fgk-representative-service-gmbh-rilonacept_sv.pdf"}},
    {"id":"69119","name":"Presentation - Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-07T11:06:28Z","last_updated_date":"2025-07-07T11:06:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-training-session-human-variations-web-based-electronic-application-form-eaf-non-caps_en.pdf-0"},
    {"id":"69120","name":"P/0299/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ceftobiprole medocaril (sodium) (Zevtera and associated names), (EMEA-000205-PIP02-11-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:17:41Z","last_updated_date":"2025-07-07T11:17:41Z","reference_number":"EMA/320724/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0299-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-ceftobiprole-medocaril-sodium-zevtera-associated-names-emea-000205-pip02-11-m07_en.pdf"},
    {"id":"69121","name":"P/0305/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin (Rydapt), (EMEA-000780-PIP01-09-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:18:59Z","last_updated_date":"2025-07-07T11:18:59Z","reference_number":"EMA/320725/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0305-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-midostaurin-rydapt-emea-000780-pip01-09-m08_en.pdf"},
    {"id":"69122","name":"P/0307/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for benralizumab (Fasenra), (EMEA-001214-PIP04-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:31:51Z","last_updated_date":"2025-07-07T11:31:51Z","reference_number":"EMA/320727/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0307-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-benralizumab-fasenra-emea-001214-pip04-19-m01_en.pdf"},
    {"id":"69123","name":"P/0303/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for human normal immunoglobulin (SCNG20%) (EMEA-001290-PIP01-12-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:33:00Z","last_updated_date":"2025-07-07T11:33:00Z","reference_number":"EMA/320731/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0303-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-human-normal-immunoglobulin-scng20-emea-001290-pip01-12-m01_en.pdf"},
    {"id":"69125","name":"P/0280/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for naltrexone (hydrochloride) / bupropion (hydrochloride) (Mysimba), (EMEA-001373-PIP01-12-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:34:02Z","last_updated_date":"2025-07-07T11:34:02Z","reference_number":"EMA/343094/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0280-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-naltrexone-hydrochloride-bupropion-hydrochloride-mysimba-emea-001373-pip01-12-m06_en.pdf"},
    {"id":"69126","name":"P/0281/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tezepelumab (Tezspire), (EMEA-001613-PIP03-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:34:55Z","last_updated_date":"2025-07-07T11:34:55Z","reference_number":"EMA/343190/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0281-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-tezepelumab-tezspire-emea-001613-pip03-21-m01_en.pdf"},
    {"id":"69127","name":"P/0282/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:35:50Z","last_updated_date":"2025-07-07T11:35:50Z","reference_number":"EMA/343346/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0282-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-sufentanil-citrate-ketamine-hydrochloride-emea-001739-pip02-16-m03_en.pdf"},
    {"id":"69128","name":"P/0283/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for rilpivirine / dolutegravir (Juluca), (EMEA-001750-PIP01-15-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:36:42Z","last_updated_date":"2025-07-07T11:36:42Z","reference_number":"EMA/343368/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0283-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-rilpivirine-dolutegravir-juluca-emea-001750-pip01-15-m07_en.pdf"},
    {"id":"69129","name":"P/0284/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza), (EMEA-001825-PIP01-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:37:36Z","last_updated_date":"2025-07-07T11:37:36Z","reference_number":"EMA/343666/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0284-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-darunavir-cobicistat-emtricitabine-tenofovir-alafenamide-symtuza-emea-001825-pip01-15-m05_en.pdf"},
    {"id":"69124","name":"Outcome of SME office survey on the implementation of the SME regulation - Commission Regulation (EC) No 2049/2005","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-07-07T12:00:00Z","last_updated_date":"2025-07-07T12:00:00Z","reference_number":"EMA/218450/2025","document_url":"https://www.ema.europa.eu/en/documents/report/outcome-sme-office-survey-implementation-sme-regulation-commission-regulation-ec-no-2049-2005_en.pdf"},
    {"id":"69130","name":"P/0312/2024: EMA decision of 22 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for avelumab (Bavencio), (EMEA-001849-PIP02-15-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:38:33Z","last_updated_date":"2025-07-07T11:38:33Z","reference_number":"EMA/374089/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0312-2024-ema-decision-22-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-avelumab-bavencio-emea-001849-pip02-15-m05_en.pdf"},
    {"id":"69132","name":"P/0290/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vadadustat (Vafseo), (EMEA-001944-PIP01-16-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:40:26Z","last_updated_date":"2025-07-07T11:40:26Z","reference_number":"EMA/343517/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0290-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-vadadustat-vafseo-emea-001944-pip01-16-m05_en.pdf"},
    {"id":"69133","name":"P/0294/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (Elucirem), (EMEA-001949-PIP01-16-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:41:24Z","last_updated_date":"2025-07-07T11:41:24Z","reference_number":"EMA/344055/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0294-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-gadopiclenol-elucirem-emea-001949-pip01-16-m07_en.pdf"},
    {"id":"69134","name":"P/0293/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gadopiclenol (Elucirem), (EMEA-001949-PIP02-18-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:43:54Z","last_updated_date":"2025-07-07T11:43:54Z","reference_number":"EMA/344196/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0293-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-gadopiclenol-elucirem-emea-001949-pip02-18-m05_en.pdf"},
    {"id":"69135","name":"P/0291/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dexamethasone (sodium phosphate) encapsulated in human autologous erthrocytes (EMEA-001957-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T12:05:42Z","last_updated_date":"2025-07-07T12:05:42Z","reference_number":"EMA/343784/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0291-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-dexamethasone-sodium-phosphate-encapsulated-human-autologous-erthrocytes-emea-001957-pip02-19-m01_en.pdf"},
    {"id":"69137","name":"P/0286/2024: EMA decision of 16 August 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for vosoritide (Voxzogo), (EMEA-002033-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T13:54:04Z","last_updated_date":"2025-07-07T13:54:04Z","reference_number":"EMA/344245/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0286-2024-ema-decision-16-august-2024-agreement-paediatric-investigation-plan-granting-deferral-vosoritide-voxzogo-emea-002033-pip02-23_en.pdf"},
    {"id":"69138","name":"P/0295/2024: EMA decision of 20 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pretomanid (Dovprela), (EMEA-002115-PIP01-17-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T13:59:08Z","last_updated_date":"2025-07-07T13:59:08Z","reference_number":"EMA/364156/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0295-2024-ema-decision-20-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-pretomanid-dovprela-emea-002115-pip01-17-m06_en.pdf"},
    {"id":"69131","name":"P/0285/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fitusiran (EMEA-001855-PIP01-15-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T11:39:35Z","last_updated_date":"2025-07-07T11:39:35Z","reference_number":"EMA/343724/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0285-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-fitusiran-emea-001855-pip01-15-m06_en.pdf"},
    {"id":"69139","name":"P/0296/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for bupivacaine / meloxicam, (EMEA-002246-PIP01-17-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T14:04:22Z","last_updated_date":"2025-07-07T14:04:22Z","reference_number":"EMA/364197/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0296-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-bupivacaine-meloxicam-emea-002246-pip01-17-m05_en.pdf"},
    {"id":"69140","name":"P/0297/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for narsoplimab, (EMEA- 002479-PIP01-18-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:08:29Z","last_updated_date":"2025-07-07T15:08:29Z","reference_number":"EMA/364312/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0297-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-narsoplimab-emea-002479-pip01-18-m02_en.pdf"},
    {"id":"69141","name":"P/0279/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for cenobamate (Ontozry), (EMEA-002563-PIP02-19-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:13:02Z","last_updated_date":"2025-07-07T15:13:02Z","reference_number":"EMA/362694/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0279-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-cenobamate-ontozry-emea-002563-pip02-19-m03_en.pdf"},
    {"id":"69143","name":"P/0298/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for efgartigimod alfa (Vyvgart), (EMEA-002597-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:19:17Z","last_updated_date":"2025-07-07T15:19:17Z","reference_number":"EMA/364330/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0298-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-efgartigimod-alfa-vyvgart-emea-002597-pip01-19-m02_en.pdf"},
    {"id":"69144","name":"P/0275/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for navepegritide (EMEA-002689-PIP02-23-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:28:26Z","last_updated_date":"2025-07-07T15:28:26Z","reference_number":"EMA/307239/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0275-2024-ema-decision-14-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-navepegritide-emea-002689-pip02-23-m01_en.pdf"},
    {"id":"69145","name":"P/0278/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for crinecerfont (EMEA-002700-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:32:59Z","last_updated_date":"2025-07-07T15:32:59Z","reference_number":"EMA/307240/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0278-2024-ema-decision-14-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-crinecerfont-emea-002700-pip01-19-m02_en.pdf"},
    {"id":"69146","name":"P/0277/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vonoprazan (EMEA-002703-PIP01-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:37:18Z","last_updated_date":"2025-07-07T15:37:18Z","reference_number":"EMA/307256/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0277-2024-ema-decision-14-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-vonoprazan-emea-002703-pip01-19-m01_en.pdf"},
    {"id":"69147","name":"P/0276/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518), (EMEA-002706-PIP01-19- M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:42:48Z","last_updated_date":"2025-07-07T15:42:48Z","reference_number":"EMA/307425/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0276-2024-ema-decision-14-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-allogeneic-bone-marrow-derived-mesenchymal-stromal-cells-ex-vivo-expanded-mc0518-emea-002706-pip01_en.pdf"},
    {"id":"69150","name":"P/0288/2024: EMA decision of 14 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for multivalent pneumococcal polysaccharide conjugate to carrier protein (PCV21) (EMEA-002780-PIP02-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T15:50:14Z","last_updated_date":"2025-07-07T15:50:14Z","reference_number":"EMA/364892/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0288-2024-ema-decision-14-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-multivalent-pneumococcal-polysaccharide-conjugate-carrier-protein-pcv21-emea-002780-pip02-20-m02_en.pdf"},
    {"id":"69151","name":"P/0259/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for survodutide (EMEA- 002942-PIP02-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T16:00:40Z","last_updated_date":"2025-07-07T16:00:40Z","reference_number":"EMA/364874/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0259-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-survodutide-emea-002942-pip02-20-m02_en.pdf"},
    {"id":"56489","name":"Pilot participation letter: Clinical study data proof-of-concept","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-10-28T13:00:00Z","last_updated_date":"2025-07-07T14:01:00Z","reference_number":"EMA/659352/2022 ","document_url":"https://www.ema.europa.eu/en/documents/other/pilot-participation-letter-clinical-study-data-proof-concept_en.pdf"},
    {"id":"69155","name":"P/0302/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for osivelotor (EMEA- 003241-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T16:39:24Z","last_updated_date":"2025-07-07T16:39:24Z","reference_number":"EMA/364883/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0302-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-osivelotor-emea-003241-pip01-22-m01_en.pdf"},
    {"id":"69156","name":"Agenda of the PRAC meeting 7-10 July 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-07-07T16:40:15Z","last_updated_date":"2025-07-07T16:40:15Z","reference_number":"EMA/PRAC/202278/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-meeting-7-10-july-2025_en.pdf"},
    {"id":"69157","name":"P/0289/2024: EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for gilteritinib (as fumarate) (Xospata), (EMEA-002064-PIP01-16-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-07T16:43:59Z","last_updated_date":"2025-07-07T16:43:59Z","reference_number":"EMA/343426/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0289-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-gilteritinib-fumarate-xospata-emea-002064-pip01-16-m06_en.pdf"},
    {"id":"69163","name":"Presentation - SPOR and XEVMPD status update (Recent and planned changes and impacts to users)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-08T13:38:17Z","last_updated_date":"2025-07-08T13:38:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spor-xevmpd-status-update-recent-planned-changes-impacts-users_en.pdf"},
    {"id":"69164","name":"CHMP PROM minutes for the meeting on 20 January 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-07-08T13:58:05Z","last_updated_date":"2025-07-08T13:58:05Z","reference_number":"EMA/CHMP/82016/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/chmp-prom-minutes-meeting-20-january-2025_en.pdf"},
    {"id":"68298","name":"External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.5","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-05-15T14:44:00Z","last_updated_date":"2025-05-15T14:44:00Z","reference_number":"EMA/90915/2016 Version 1.5","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use-version-15_en.pdf"},
    {"id":"69165","name":"Minutes of the CAT meeting 14-16 May 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-07-08T14:09:39Z","last_updated_date":"2025-07-08T14:09:39Z","reference_number":"EMA/CAT/223455/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-14-16-may-2025_en.pdf"},
    {"id":"69166","name":"Minutes of the CHMP meeting 24-27 February 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-07-08T14:35:00Z","last_updated_date":"2025-07-08T14:35:00Z","reference_number":"EMA/CHMP/91836/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-24-27-february-2025_en.pdf"},
    {"id":"69167","name":"Annex to 24-27 February 2025 CHMP Minutes","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-07-08T14:32:00Z","last_updated_date":"2025-07-08T14:32:00Z","reference_number":"EMA/CHMP/79634/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/annex-24-27-february-2025-chmp-minutes_en.xlsx"},
    {"id":"68167","name":"Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-05-08 - 2025-07-08","first_published_date":"2025-05-08T12:20:38Z","last_updated_date":"2025-05-08T12:20:38Z","reference_number":"EMA/INS/GMP/48771/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-part-iv-guidelines-good-manufacturing-practice-specific-advanced-therapy-medicinal-products_en.pdf"},
    {"id":"51560","name":"Guide to CTIS training material catalogue","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-06-23T15:25:00Z","last_updated_date":"2025-07-09T17:58:00Z","reference_number":"Version 2 – July 2025","document_url":"https://www.ema.europa.eu/en/documents/other/guide-ctis-training-material-catalogue_en.pdf"},
    {"id":"68686","name":"Agenda – 14th Industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-11T11:06:49Z","last_updated_date":"2025-07-09T13:29:04Z","reference_number":"EMA/119654/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-14th-industry-stakeholder-platform-research-development-support_en.pdf"},
    {"id":"69181","name":"Presentation - Early engagement fostering innovation (M. Filancia, O. Blanquie, E. Tognana, T. Ballotti, G. Lorenti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:29:11Z","last_updated_date":"2025-07-09T13:29:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-early-engagement-fostering-innovation-m-filancia-o-blanquie-e-tognana-t-ballotti-g-lorenti_en.pdf"},
    {"id":"69182","name":"Presentation - Update on the stepwise PIP pilot (C. Pallidis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:31:17Z","last_updated_date":"2025-07-09T13:31:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-stepwise-pip-pilot-c-pallidis_en.pdf"},
    {"id":"69183","name":"Presentation - Focus group on use of RWD and generation of RWE (A. Segec)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:32:46Z","last_updated_date":"2025-07-09T13:32:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-use-rwd-generation-rwe-segec_en.pdf"},
    {"id":"69185","name":"Presentation - Horizon Scanning activities at EMA (V. Cordo, E. Tognana, F. Ehmann)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:35:33Z","last_updated_date":"2025-07-09T13:35:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-horizon-scanning-activities-ema-v-cordo-e-tognana-f-ehmann_en.pdf"},
    {"id":"69186","name":"Presentation - Implementation of pilot initiatives based on first 5 years’ experience of PRIME: Analysis (K. Cunningham)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:36:35Z","last_updated_date":"2025-07-09T13:36:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-pilot-initiatives-based-first-5-years-experience-prime-analysis-k-cunningham_en.pdf"},
    {"id":"69187","name":"Presentation - Reframing the voluntary data submission (S. Ponzano, O. Moriarty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:37:56Z","last_updated_date":"2025-07-09T13:37:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reframing-voluntary-data-submission-s-ponzano-o-moriarty_en.pdf"},
    {"id":"69189","name":"Presentation - Updates from EMA on scientific advice; 14th Industry stakeholder platform on research and development support (I. Gravanis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:39:51Z","last_updated_date":"2025-07-09T13:39:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-ema-scientific-advice-14th-industry-stakeholder-platform-research-development-support-i-gravanis_en.pdf"},
    {"id":"69184","name":"Presentation - Future-proofing Qualification of Novel Methodologies (QoNM) (T. Vetter)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-09T13:34:16Z","last_updated_date":"2025-07-09T13:34:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-future-proofing-qualification-novel-methodologies-qonm-t-vetter_en.pdf"},
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    {"id":"67839","name":"Draft list of references supporting the assessment of Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC. or their hybrids; C. pentagyna Waldst. et Kit. ex Willd.; C. azarolus L.","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T11:56:40Z","last_updated_date":"2025-04-15T11:56:40Z","reference_number":"EMA/HMPC/234780/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-crataegus-monogyna-jacq-lindm-c-laevigata-poir-dc-or-their-hybrids-c-pentagyna-waldst-et-kit-ex-willd-c-azarolus-l_en.pdf"},
    {"id":"67840","name":"Draft assessment report on Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC. or their hybrids; C. pentagyna Waldst. et Kit. ex Willd.; C. azarolus L.","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T11:59:21Z","last_updated_date":"2025-04-15T11:59:21Z","reference_number":"EMA/HMPC/116318/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-crataegus-monogyna-jacq-lindm-c-laevigata-poir-dc-or-their-hybrids-c-pentagyna-waldst-et-kit-ex-willd-c-azarolus-l_en.pdf"},
    {"id":"67841","name":"Draft European Union herbal monograph on Arnica montana L., flos","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T12:07:17Z","last_updated_date":"2025-04-15T12:07:17Z","reference_number":"EMA/HMPC/524586/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-arnica-montana-l-flos_en.pdf"},
    {"id":"67842","name":"Draft list of references supporting the assessment of Arnica montana L., flos","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T12:10:21Z","last_updated_date":"2025-04-15T12:10:21Z","reference_number":"EMA/HMPC/524584/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-arnica-montana-l-flos_en.pdf-0"},
    {"id":"67844","name":"Draft assessment report on Arnica montana L., flos","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T12:12:06Z","last_updated_date":"2025-04-15T12:12:06Z","reference_number":"EMA/HMPC/432016/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-arnica-montana-l-flos_en.pdf-0"},
    {"id":"67845","name":"Draft European Union herbal monograph on Allium sativum L., bulbus","type":"herbal-monograph","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T12:17:44Z","last_updated_date":"2025-04-15T12:17:44Z","reference_number":"EMA/HMPC/329435/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-monograph/draft-european-union-herbal-monograph-allium-sativum-l-bulbus_en.pdf-0"},
    {"id":"67846","name":"Draft list of references supporting the assessment of Allium sativum L., bulbus","type":"herbal-references","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T12:19:41Z","last_updated_date":"2025-04-15T12:19:41Z","reference_number":"EMA/HMPC/329434/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-references/draft-list-references-supporting-assessment-allium-sativum-l-bulbus_en.pdf-0"},
    {"id":"67847","name":"Draft assessment report on Allium sativum L., bulbus","type":"herbal-report","status":"Draft: consultation closed","consultation_date":"2025-04-15 - 2025-07-15","first_published_date":"2025-04-15T12:21:38Z","last_updated_date":"2025-04-15T12:21:38Z","reference_number":"EMA/HMPC/329433/2024","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/draft-assessment-report-allium-sativum-l-bulbus_en.pdf-0"},
    {"id":"69307","name":"Presentation - Redesign of the CTIS training material for sponsor users - CTIS Bitesize talk 9 July 2025","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T11:23:30Z","last_updated_date":"2025-07-16T11:23:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-redesign-ctis-training-material-sponsor-users-ctis-bitesize-talk-9-july-2025_en.pdf"},
    {"id":"64336","name":"Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.17","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2024-07-26T10:33:50Z","last_updated_date":"2025-07-16T13:55:00Z","reference_number":"EMA/CVMP/PhVWP/288284/2007 Rev.17 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-notes-use-veterinary-dictionary-drug-regulatory-activities-veddra-terminology-reporting-suspected-adverse-events-animals-humans-rev17_en.pdf"},
    {"id":"15743","name":"Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-05-18T12:00:00Z","last_updated_date":"2025-07-16T14:26:00Z","reference_number":"EMA/207532/2025","document_url":"https://www.ema.europa.eu/en/documents/other/guide-information-human-medicines-evaluated-european-medicines-agency-what-agency-publishes-when_en.pdf"},
    {"id":"69320","name":"Presentation - Introduction to the assessment of medicines in the EU (B. Sepodes, CHMP Chair)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T16:37:09Z","last_updated_date":"2025-07-16T16:37:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-assessment-medicines-eu-b-sepodes-chmp-chair_en.pdf"},
    {"id":"69321","name":"Presentation - The clinical assessment (A. Cunney, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T16:38:00Z","last_updated_date":"2025-07-16T16:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-assessment-cunney-ema_en.pdf"},
    {"id":"69322","name":"Presentation - The inspection process (T. Holmberg, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T16:38:32Z","last_updated_date":"2025-07-16T16:38:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-inspection-process-t-holmberg-ema_en.pdf"},
    {"id":"69323","name":"Presentation - Opportunities for expert involvement in our core assessment  and related activities (F. Day, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T16:39:07Z","last_updated_date":"2025-07-16T16:39:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-expert-involvement-our-core-assessment-related-activities-f-day-ema_en.pdf"},
    {"id":"69326","name":"Presentation - EMA Quality Innovation Group (QIG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T16:47:38Z","last_updated_date":"2025-07-16T16:47:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-quality-innovation-group-qig_en.pdf"},
    {"id":"69327","name":"Presentation - ICMRA collaborative assessment pilots","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-16T16:49:42Z","last_updated_date":"2025-07-16T16:49:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-icmra-collaborative-assessment-pilots_en.pdf"},
    {"id":"61494","name":"Advice on implementing measures under Article 93(2) of Reg (EU) 2019/6 of the European Parliament and of the Council on Veterinary Medicinal Products, as regards the GMP for veterinary medicinal products and active substances used as starting materials","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-12-19T11:00:00Z","last_updated_date":"2023-12-19T11:00:00Z","reference_number":"EMA/INS/GMP/533512/2023","document_url":"https://www.ema.europa.eu/en/documents/other/advice-implementing-measures-under-article-932-reg-eu-2019-6-european-parliament-council-veterinary-medicinal-products-regards-gmp-veterinary-medicinal-products-active-substances-used-starting_en.pdf"},
    {"id":"48821","name":"Advice on implementing measures under Art 106(6) of Reg (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via routes other ...","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2020-09-16T12:00:00Z","last_updated_date":"2020-09-16T12:00:00Z","reference_number":"EMA/CVMP/508559/2019","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/advice-implementing-measures-under-art-1066-reg-eu-2019-6-veterinary-medicinal-products-scientific-problem-analysis-recommendations-ensure-safe-efficient-administration-oral-veterinary-medicinal_en.pdf"},
    {"id":"65167","name":"P/0304/2024 : EMA decision of 16 August 2024 on the acceptance of a modification of an agreed paediatric investigation plan for humanised monoclonal antibody derivative against fibroblast growth factor receptor 3 (SAR442501) (EMEA- 003253-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2024-10-04T14:00:00Z","last_updated_date":"2024-10-04T14:00:00Z","reference_number":"EMA/364885/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0304-2024-ema-decision-16-august-2024-acceptance-modification-agreed-paediatric-investigation-plan-humanised-monoclonal-antibody-derivative-against-fibroblast-growth-factor-receptor-3-sar442501-emea_en.pdf"},
    {"id":"69332","name":"Presentation - Commission proposal for a Critical Medicines Act","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T09:14:35Z","last_updated_date":"2025-07-17T09:14:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-commission-proposal-critical-medicines-act_en.pdf"},
    {"id":"69338","name":"Comirnaty : 3.2.S.2.6 manufacturing process development","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T10:45:36Z","last_updated_date":"2025-07-17T10:45:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comirnaty-32s26-manufacturing-process-development_en.zip"},
    {"id":"69339","name":"Comirnaty : 3.2.S.2.4 controls of critical steps and intermediates","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T10:47:37Z","last_updated_date":"2025-07-17T10:47:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comirnaty-32s24-controls-critical-steps-intermediates_en.zip"},
    {"id":"13498","name":"Tylvalosin (acetylisovaleryltylosin) (modification of the acceptable daily intake, ADI): European Public MRL Assessment Report (EPMAR) - CVMP","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2007-11-28T00:09:21Z","last_updated_date":"2007-11-28T00:09:21Z","reference_number":"EMEA/CVMP/469245/2007-FINAL","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/tylvalosin-acetylisovaleryltylosin-modification-acceptable-daily-intake-adi-european-public-mrl-assessment-report-epmar-cvmp_en.pdf"},
    {"id":"69360","name":"Presentation - Bayesian borrowing in clinical trial test decisions: Frequentist type I error rate and power (A. Kopp-Schneider, DKFZ)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:12:49Z","last_updated_date":"2025-07-18T11:12:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-borrowing-clinical-trial-test-decisions-frequentist-type-i-error-rate-power-kopp-schneider-dkfz_en.pdf"},
    {"id":"69361","name":"Presentation - Opportunities and challenges of using Bayesian Methods to support regulatory decision making (N. Best, GSK)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:15:40Z","last_updated_date":"2025-07-18T11:15:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-opportunities-challenges-using-bayesian-methods-support-regulatory-decision-making-n-best-gsk_en.pdf"},
    {"id":"69362","name":"Presentation - EU Concept Paper on the use of Bayesian statistics in clinical development (P.van de Ven, CBG MEB)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:18:50Z","last_updated_date":"2025-07-18T11:18:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-concept-paper-use-bayesian-statistics-clinical-development-pvan-de-ven-cbg-meb_en.pdf"},
    {"id":"69363","name":"Presentation - ICH E20: an industry perspective (U.Bretz, Novartis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:20:54Z","last_updated_date":"2025-07-18T11:20:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-e20-industry-perspective-ubretz-novartis_en.pdf"},
    {"id":"69364","name":"Presentation - ICH E20: a regulatory perspective (F.Petavy, A.Koch, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:23:09Z","last_updated_date":"2025-07-18T11:23:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-e20-regulatory-perspective-fpetavy-akoch-ema_en.pdf"},
    {"id":"69365","name":"Presentation - Bayesian methods without borrowing in ultrarare diseases (N.Muehlemann, J.Priel, Cytel)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:25:49Z","last_updated_date":"2025-07-18T11:25:49Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-methods-without-borrowing-ultrarare-diseases-nmuehlemann-jpriel-cytel_en.pdf"},
    {"id":"69366","name":"Presentation - Bayesian Adaptive Design for a Practice-Changing Platform Trial in a Rare Paediatric Cancer: The Glo-BNHL Trial (L.Billingham, University of Birmingham)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:28:00Z","last_updated_date":"2025-07-18T11:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-adaptive-design-practice-changing-platform-trial-rare-paediatric-cancer-glo-bnhl-trial-lbillingham-university-birmingham_en.pdf"},
    {"id":"69367","name":"Presentation - Bayesian methods to support clinical interpretation of treatment effects, interim decision making and handling of intercurrent events (N.Best, P.Dalvi, GSK)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:29:28Z","last_updated_date":"2025-07-18T11:29:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-methods-support-clinical-interpretation-treatment-effects-interim-decision-making-handling-intercurrent-events-nbest-pdalvi-gsk_en.pdf"},
    {"id":"69368","name":"Presentation - Bayesian borrowing for paediatric extrapolation: The DINAMO study (M.Sailer, I.Tartakovsky, Boehringer Ingelheim Pharma GmbH & Co. KG)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:30:50Z","last_updated_date":"2025-07-18T11:30:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-borrowing-paediatric-extrapolation-dinamo-study-msailer-itartakovsky-boehringer-ingelheim-pharma-gmbh-co-kg_en.pdf"},
    {"id":"69369","name":"Presentation - A regulator’s perspective on pediatric Bayesian Methods (J.Travis, US FDA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:32:15Z","last_updated_date":"2025-07-18T11:32:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulators-perspective-pediatric-bayesian-methods-jtravis-us-fda_en.pdf"},
    {"id":"69370","name":"Presentation - Bayesian shrinkage methods for routine estimation of subgroup treatment effects (B.Bornkamp, Novartis; N.Best, D.Bratton, GSK; M.Jelizarow, UCB; N.Muhlemann, Cytel; J.McMurray, University of Glasgow)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:34:05Z","last_updated_date":"2025-07-18T11:34:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-shrinkage-methods-routine-estimation-subgroup-treatment-effects-bbornkamp-novartis-nbest-dbratton-gsk-mjelizarow-ucb-nmuhlemann-cytel-jmcmurray-university-glasgow_en.pdf"},
    {"id":"69371","name":"Presentation - ICH-M15 for Bayesian Modelling: A systematic model assessment framework to support design submission and discussion (T.Mielke, Johnson&Johnson)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:36:43Z","last_updated_date":"2025-07-18T11:36:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ich-m15-bayesian-modelling-systematic-model-assessment-framework-support-design-submission-discussion-tmielke-johnsonjohnson_en.pdf"},
    {"id":"69372","name":"Presentation - Bayesian statistics in regulatory decision-making: Panacea or Pandora’s Box? (K.Karlsson, MWP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T11:38:41Z","last_updated_date":"2025-07-18T11:38:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-bayesian-statistics-regulatory-decision-making-panacea-or-pandoras-box-kkarlsson-mwp_en.pdf"},
    {"id":"69373","name":"CVMP summary of positive opinion for Cevac Reomune","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-07-18T12:19:50Z","last_updated_date":"2025-07-18T12:19:50Z","reference_number":"EMA/CVMP/31091/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-cevac-reomune_en.pdf"},
    {"id":"69376","name":"Quarter-based selective dry cow therapy 141(1)(i) procedure - Start of review","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T13:34:16Z","last_updated_date":"2025-07-18T13:34:16Z","reference_number":"EMA/235687/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/quarter-based-selective-dry-cow-therapy-1411i-procedure-start-review_en.pdf"},
    {"id":"69378","name":"Quarter-based selective dry cow therapy 141(1)(i) procedure -  CVMP list of questions to be addressed by stakeholders","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T13:37:27Z","last_updated_date":"2025-07-18T13:37:27Z","reference_number":"EMA/CVMP/231325/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/quarter-based-selective-dry-cow-therapy-1411i-procedure-cvmp-list-questions-be-addressed-stakeholders_en.pdf"},
    {"id":"69379","name":"Quarter-based selective dry cow therapy 141(1)(i) procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T13:39:32Z","last_updated_date":"2025-07-18T13:39:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/quarter-based-selective-dry-cow-therapy-1411i-procedure-notification_en.pdf"},
    {"id":"68754","name":"CVMP post-authorisation summary of positive opinion for Nobivac L4 and Nobivac LoVo L4 (VRA0000184065)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-06-13T15:35:17Z","last_updated_date":"2025-07-18T00:00:00Z","reference_number":"EMADOC-1700519818-2188844","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-nobivac-l4-nobivac-lovo-l4-vra0000184065_en.pdf"},
    {"id":"69382","name":"Regulatory Science - Research needs - 2025 update","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T14:54:09Z","last_updated_date":"2025-07-18T14:54:09Z","reference_number":"EMA/510633/2024","document_url":"https://www.ema.europa.eu/en/documents/other/regulatory-science-research-needs-2025-update_en.pdf"},
    {"id":"53480","name":"Regulatory Science - Research needs","type":"other","status":"unknown","consultation_date":"","first_published_date":"2021-12-15T11:47:00Z","last_updated_date":"2021-12-15T11:47:00Z","reference_number":"EMA/705364/2021","document_url":"https://www.ema.europa.eu/en/documents/other/regulatory-science-research-needs_en.pdf"},
    {"id":"68709","name":"Applications for new human medicines under evaluation: June 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-06-12T09:35:00Z","last_updated_date":"2025-06-12T09:35:00Z","reference_number":"EMA/187336/2025","document_url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-june-2025_en.xlsx"},
    {"id":"68254","name":"Applications for new human medicines under evaluation: May 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-05-13T13:25:30Z","last_updated_date":"2025-05-13T13:25:30Z","reference_number":"EMA/153582/2025","document_url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-may-2025_en.xlsx"},
    {"id":"69389","name":"Applications for new human medicines under evaluation: July 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T15:50:42Z","last_updated_date":"2025-07-18T15:50:42Z","reference_number":"EMA/134672/2025","document_url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-july-2025_en.xlsx"},
    {"id":"69391","name":"PMS data matrix - Cross-platforms","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T16:00:19Z","last_updated_date":"2025-07-18T16:00:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/pms-data-matrix-cross-platforms_en.xlsx"},
    {"id":"69394","name":"Highlights from the 13th meeting of the Nitrosamine Implementation Oversight Group (NIOG)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-07-21T14:22:17Z","last_updated_date":"2025-07-21T14:22:17Z","reference_number":"EMA/166991/2025","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-13th-meeting-nitrosamine-implementation-oversight-group-niog_en.pdf"},
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    {"id":"69450","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2024-08-05T16:08:49Z","last_updated_date":"2024-08-05T16:08:49Z","reference_number":"EMA/340669/2024","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-final-revision-3-module-xvi-risk-minimisation-measures-its-addendum-ii-their-effectiveness-evaluation-revision-5_en.pdf"},
    {"id":"64503","name":"Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2025-07-24T16:03:00Z","last_updated_date":"2025-07-24T16:03:00Z","reference_number":"EMA/236736/2025","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-new-addendum-ii-module-vi-masking-personal-data-individual-case-safety-reports-submitted-eudravigilance_en.pdf"},
    {"id":"17432","name":"Origio - Procedural steps and scientific information after initial consultation (archive)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-01T18:00:00Z","last_updated_date":"2025-07-24T10:31:00Z","reference_number":"Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/other/origio-procedural-steps-scientific-information-after-initial-consultation-archive_en.pdf"},
    {"id":"69465","name":"Origio - Procedural steps and scientific information after initial consultation ","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-24T19:19:31Z","last_updated_date":"2025-07-24T19:19:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/origio-procedural-steps-scientific-information-after-initial-consultation_en.pdf"},
    {"id":"69467","name":"Origio - Procedural steps and scientific information after initial consultation","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-24T19:23:02Z","last_updated_date":"2025-07-24T19:23:02Z","reference_number":"Rev. 6","document_url":"https://www.ema.europa.eu/en/documents/other/origio-procedural-steps-scientific-information-after-initial-consultation_en.pdf-0"},
    {"id":"50370","name":"LifeGlobal Media - Procedural steps and scientific information after initial consultation (archive)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-03-08T12:43:00Z","last_updated_date":"2025-07-24T14:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/lifeglobal-media-procedural-steps-scientific-information-after-initial-consultation-archive_en.pdf"},
    {"id":"24045","name":"CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation (archive)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-08-01T18:00:00Z","last_updated_date":"2025-07-24T10:34:00Z","reference_number":"Rev. 5","document_url":"https://www.ema.europa.eu/en/documents/other/coopersurgical-inc-art-media-procedural-steps-scientific-information-after-initial-consultation-archive_en.pdf"},
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    {"id":"68161","name":"Ixchiq Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-05-08T11:03:19Z","last_updated_date":"2025-05-08T11:03:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ixchiq-article-20-procedure-notification_en.pdf"},
    {"id":"69241","name":"Ixchiq Article-20 procedure - Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-11T12:24:14Z","last_updated_date":"2025-07-11T12:24:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/ixchiq-article-20-procedure-ixchiq-temporary-restriction-vaccinating-people-65-years-older-be-lifted_en.pdf"},
    {"id":"69478","name":"CHMP summary of positive opinion for Bildyos","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T10:30:46Z","last_updated_date":"2025-07-25T10:30:46Z","reference_number":"EMA/CHMP/228095/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bildyos_en.pdf"},
    {"id":"69479","name":"CHMP summary of positive opinion for Bilprevda","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T10:32:57Z","last_updated_date":"2025-07-25T10:32:57Z","reference_number":"EMA/CHMP/228070/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-bilprevda_en.pdf"},
    {"id":"69491","name":"CHMP summary of positive opinion for Yeytuo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T11:25:24Z","last_updated_date":"2025-07-25T11:25:24Z","reference_number":"EMA/CHMP/243442/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-yeytuo_en.pdf"},
    {"id":"68425","name":"Questions and answers on the refusal of the marketing authorisation for Aplidin (plitidepsin)","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2025-05-23T15:39:44Z","last_updated_date":"2025-05-23T15:39:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-aplidin-plitidepsin_en.pdf"},
    {"id":"69474","name":"Withdrawal letter: Aplidin","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T09:29:48Z","last_updated_date":"2025-07-25T09:29:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-aplidin_en.pdf"},
    {"id":"69459","name":"Tecovirimat SIGA Article-20 procedure - EMA starts review of Tecovirimat SIGA","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T00:00:00Z","last_updated_date":"2025-07-25T00:00:00Z","reference_number":"EMA/239080/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/tecovirimat-siga-article-20-procedure-ema-starts-review-tecovirimat-siga_en.pdf"},
    {"id":"69461","name":"Tecovirimat SIGA Article-20 procedure - CHMP list of questions","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T18:37:48Z","last_updated_date":"2025-07-25T18:37:48Z","reference_number":"EMADOC-1700519818-2313948","document_url":"https://www.ema.europa.eu/en/documents/referral/tecovirimat-siga-article-20-procedure-chmp-list-questions_en.pdf"},
    {"id":"69462","name":"Tecovirimat SIGA Article-20 procedure - Notification","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T18:39:00Z","last_updated_date":"2025-07-25T18:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/referral/tecovirimat-siga-article-20-procedure-notification_en.pdf"},
    {"id":"69493","name":"CHMP summary of positive opinion for Lenacapavir Gilead","type":"outside-EU-smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T11:44:25Z","last_updated_date":"2025-07-25T11:44:25Z","reference_number":"EMA/CHMP/243443/2025","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-smop-initial/chmp-summary-positive-opinion-lenacapavir-gilead_en.pdf"},
    {"id":"69449","name":"Withdrawal letter: Nidlegy","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T12:00:00Z","last_updated_date":"2025-07-25T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-nidlegy_en.pdf"},
    {"id":"69436","name":"Overview of comments received on the Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (second version)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T10:00:00Z","last_updated_date":"2025-07-25T10:00:00Z","reference_number":"EMA/CVMP/EWP/58808/2025","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-demonstration-efficacy-veterinary-medicinal-products-containing-anticoccidial-substances-revision-1-second-version_en.pdf"},
    {"id":"69435","name":"Overview of comments received on the\tDraft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (first version)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T10:00:00Z","last_updated_date":"2025-07-25T10:00:00Z","reference_number":"EMA/CVMP/EWP/479402/2019","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-draft-guideline-demonstration-efficacy-veterinary-medicinal-products-containing-anticoccidial-substances-revision-1-first-version_en.pdf"},
    {"id":"69437","name":"Guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T10:00:00Z","last_updated_date":"2025-07-25T10:00:00Z","reference_number":"EMA/CVMP/EWP/755916/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-demonstration-efficacy-veterinary-medicinal-products-containing-anticoccidial-substances-revision-1_en.pdf"},
    {"id":"69496","name":"European Union Member State Public Holidays Recorded in CTIS (year: 2026)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T14:14:41Z","last_updated_date":"2025-07-25T14:14:41Z","reference_number":"EMA/240605/2025","document_url":"https://www.ema.europa.eu/en/documents/other/european-union-member-state-public-holidays-recorded-ctis-year-2026_en.pdf"},
    {"id":"69341","name":"Comirnaty : 3.2.S.2.2 description of manufacturing process","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T10:50:22Z","last_updated_date":"2025-07-25T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comirnaty-32s22-description-manufacturing-process_en.zip"},
    {"id":"69340","name":"Comirnaty : 3.2.S.2.3 control of materials","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T10:48:49Z","last_updated_date":"2025-07-25T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comirnaty-32s23-control-materials_en.zip"},
    {"id":"69500","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 07-09 July 2025","type":"committee-report","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T14:35:38Z","last_updated_date":"2025-07-25T14:35:38Z","reference_number":"EMA/HMPC/227855/2025","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-07-09-july-2025_en.pdf"},
    {"id":"69501","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Ifinwil (eflornithine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T14:45:39Z","last_updated_date":"2025-07-25T14:45:39Z","reference_number":"EMA/238203/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-ifinwil-eflornithine_en.pdf"},
    {"id":"69502","name":"Withdrawal letter: Ifinwil","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T15:04:57Z","last_updated_date":"2025-07-25T15:04:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ifinwil_en.pdf"},
    {"id":"69504","name":"Overview of comments received on ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver (EMA/CHMP/ICH/85092/2025)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T16:18:05Z","last_updated_date":"2025-07-25T16:18:05Z","reference_number":"EMA/237572/2025","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-m13b-guideline-bioequivalence-immediate-release-solid-oral-dosage-forms-additional-strengths-biowaiver-ema-chmp-ich-85092-2025_en.pdf"},
    {"id":"69455","name":"Questions and answers on the outcome of assessment on use of Neuraceq to monitor treatment response","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T12:24:24Z","last_updated_date":"2025-07-25T12:24:24Z","reference_number":"EMA/310493/2020","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-outcome-assessment-use-neuraceq-monitor-treatment-response_en.pdf"},
    {"id":"69506","name":"Presentation - Regulatory perspective on clinically relevant endpoints for COVID-19 and Influenza (S. Buchholz, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-perspective-clinically-relevant-endpoints-covid-19-influenza-s-buchholz-ema_en.pdf"},
    {"id":"69525","name":"Presentation -  Remdesivir: The search for an effective treatment for COVID-19 (Y.Murata, Gilead Sciences)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-remdesivir-search-effective-treatment-covid-19-ymurata-gilead-sciences_en.pdf"},
    {"id":"69524","name":"Presentation -  Challenges associated with the (pre-)approval of clinical study protocols: Clinician perspective (K.Lacombe, Sorbonne University)famhp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-associated-pre-approval-clinical-study-protocols-clinician-perspective-klacombe-sorbonne-universityfamhp_en.pdf"},
    {"id":"69523","name":"Presentation -  Challenges associated with the (pre-)approval of clinical study protocols: Regulatory perspective (famhp)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-associated-pre-approval-clinical-study-protocols-regulatory-perspective-famhp_en.pdf"},
    {"id":"69522","name":"Presentation - Pandemic preparedness: Potential clinical study designs for clinical trials intended to be conducted in case of an outbreak (Y.Yazdanpanah, Paris Cite University / I.Olsen, Oslo University Hospital)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pandemic-preparedness-potential-clinical-study-designs-clinical-trials-intended-be-conducted-case-outbreak-yyazdanpanah-paris-cite-university-iolsen-oslo-university-hospital_en.pdf"},
    {"id":"69521","name":"Presentation - Pandemic Preparedness Session: Importance of pre-approved protocols (I.Olsen, Oslo University Hospital)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-pandemic-preparedness-session-importance-pre-approved-protocols-iolsen-oslo-university-hospital_en.pdf"},
    {"id":"69520","name":"Presentation - Convalescent plasma for treatment of respiratory viruses (D.Focosi, Pisa University Hospital)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-convalescent-plasma-treatment-respiratory-viruses-dfocosi-pisa-university-hospital_en.pdf"},
    {"id":"69519","name":" Presentation - Challenges in evidence generation for COVID-19 mAbs: Industry experience (Leyden Labs)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-evidence-generation-covid-19-mabs-industry-experience-leyden-labs_en.pdf"},
    {"id":"69518","name":" Presentation - Challenges in evidence generation for COVID-19 mAbs: Industry experience (AstraZeneca)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-evidence-generation-covid-19-mabs-industry-experience-astrazeneca_en.pdf"},
    {"id":"69517","name":" Presentation - Challenges in evidence generation for COVID-19 mAbs: A clinician experience (P.Horby, University of Oxford)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-evidence-generation-covid-19-mabs-clinician-experience-phorby-university-oxford_en.pdf"},
    {"id":"69516","name":"Presentation - Challenges in evidence generation for COVID-19 mAbs: A regulatory experience (F.Josephson, Swedish Medical Products Agency)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-evidence-generation-covid-19-mabs-regulatory-experience-fjosephson-swedish-medical-products-agency_en.pdf"},
    {"id":"69515","name":"Presentation - Clinical evidence for viral load as surrogate endpoint for antivirals for COVID-19 (F.Hayden, University of Virginia)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-evidence-viral-load-surrogate-endpoint-antivirals-covid-19-fhayden-university-virginia_en.pdf"},
    {"id":"69514","name":"Presentation - Clinical evidence for viral load as surrogate endpoint for antivirals for COVID-19 (M.Hughes, Harvard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinical-evidence-viral-load-surrogate-endpoint-antivirals-covid-19-mhughes-harvard_en.pdf"},
    {"id":"69513","name":"Presentation - Antivirals for pre- or post-exposure prophylaxis (C.Wolfe, Duke Medicine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antivirals-pre-or-post-exposure-prophylaxis-cwolfe-duke-medicine_en.pdf"},
    {"id":"69512","name":"Presentation - Efficacy of influenza antivirals in prophylaxis (University of Michigan)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-efficacy-influenza-antivirals-prophylaxis-university-michigan_en.pdf"},
    {"id":"69511","name":"Presentation - Antiviral development landscape for COVID-19 & Influenza (Intrepid Alliance)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-antiviral-development-landscape-covid-19-influenza-intrepid-alliance_en.pdf"},
    {"id":"69510","name":"Presentation - What are clinically relevant study endpoints for COVID-19 and Influenza? Considerations for the immunocompromised host (M.Boeckh, Fred Hutchinson Cancer Center)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-are-clinically-relevant-study-endpoints-covid-19-influenza-considerations-immunocompromised-host-mboeckh-fred-hutchinson-cancer-center_en.pdf"},
    {"id":"69509","name":"Presentation - Respiratory virus endpoints (S.Portsmouth, Shionogi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-respiratory-virus-endpoints-sportsmouth-shionogi_en.pdf"},
    {"id":"69508","name":"Presentation - Clinically Relevant Endpoints for Covid-19 and Influenza (R.Chandra, Novartis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinically-relevant-endpoints-covid-19-influenza-rchandra-novartis_en.pdf"},
    {"id":"69507","name":"Presentation - Clinically relevant endpoints for COVID-19 and influenza:a clinician perspective (L.Peto, University of Oxford)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-clinically-relevant-endpoints-covid-19-influenzaa-clinician-perspective-lpeto-university-oxford_en.pdf"},
    {"id":"69505","name":"Presentation - Similarities and differences between SARS-CoV-2 and Influenza (L. Derde, UMC Utrecht)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T11:11:11Z","last_updated_date":"2025-07-28T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-similarities-differences-between-sars-cov-2-influenza-l-derde-umc-utrecht_en.pdf"},
    {"id":"68241","name":"Agenda - EMA workshop on primary efficacy endpoints  for antivirals and monoclonal antibodies intended to treat COVID-19 and Influenza","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-05-12T16:47:21Z","last_updated_date":"2025-07-28T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-workshop-primary-efficacy-endpoints-antivirals-monoclonal-antibodies-intended-treat-covid-19-influenza_en.pdf"},
    {"id":"69533","name":"Response to Paediatric Committee request for supplementary information and modification of proposed PIP (RSI) - Re-submission following clock-stop","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T13:40:05Z","last_updated_date":"2025-07-28T13:40:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/response-paediatric-committee-request-supplementary-information-modification-proposed-pip-rsi-re-submission-following-clock-stop_en.docx"},
    {"id":"69534","name":"Additional information - Applicant’s clarifications following Paediatric Committee (PDCO) discussions or re-discussions","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T13:40:07Z","last_updated_date":"2025-07-28T13:40:07Z","reference_number":"EMA/241572/2025","document_url":"https://www.ema.europa.eu/en/documents/template-form/additional-information-applicants-clarifications-following-paediatric-committee-pdco-discussions-or-re-discussions_en.docx"},
    {"id":"69544","name":"Questions & Answers extract - SPOR and XEVMPD status update webinar 9 July 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T14:45:31Z","last_updated_date":"2025-07-28T14:45:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/questions-answers-extract-spor-xevmpd-status-update-webinar-9-july-2025_en.pdf"},
    {"id":"69552","name":"Start of procedure: Extension of marketing authorisation (20 June 2025 - 24 July 2025)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T16:09:59Z","last_updated_date":"2025-07-28T16:09:59Z","reference_number":"EMA/244908/2025","document_url":"https://www.ema.europa.eu/en/documents/report/start-procedure-extension-marketing-authorisation-20-june-2025-24-july-2025_en.xlsx"},
    {"id":"69553","name":"Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (20 June 2025 - 24 July 2025)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-07-28T16:12:52Z","last_updated_date":"2025-07-28T16:12:52Z","reference_number":"EMA/244915/2025","document_url":"https://www.ema.europa.eu/en/documents/report/start-procedure-type-ii-variation-extension-indication-under-evaluation-chmp-20-june-2025-24-july-2025_en.xlsx"},
    {"id":"69555","name":"Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-07-29T09:33:40Z","last_updated_date":"2025-07-29T09:33:40Z","reference_number":"EMA/144509/2025","document_url":"https://www.ema.europa.eu/en/documents/report/report-european-medicines-regulatory-networks-response-nitrosamine-impurities-human-medicines_en.pdf"},
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    {"id":"70290","name":"Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 15-18 September 2025","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2025-09-26T09:06:07Z","last_updated_date":"2025-09-26T09:06:07Z","reference_number":"EMA/290349/2025","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-15-18-september-2025_en.pdf"},
    {"id":"70285","name":"Agenda - European Platform for Regulatory Science Research meeting September 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-09-25T16:46:59Z","last_updated_date":"2025-09-26T09:33:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-platform-regulatory-science-research-meeting-september-2025_en.pdf"},
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    {"id":"69711","name":"Minutes of the COMP meeting 10-12 June 2025","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-08-12T16:37:58Z","last_updated_date":"2025-08-12T16:37:58Z","reference_number":"EMA/COMP/267913/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-comp-meeting-10-12-june-2025_en.xlsx"},
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    {"id":"70314","name":"New product information wording: extracts from PRAC recommendations on signals adopted at the 1-4 September 2025 PRAC","type":"prac-recommendation","status":"Adopted","consultation_date":"","first_published_date":"2025-09-29T13:39:36Z","last_updated_date":"2025-09-29T13:39:36Z","reference_number":"EMA/PRAC/271799/2025","document_url":"https://www.ema.europa.eu/en/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_bg.pdf","es":"https://www.ema.europa.eu/es/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_cs.pdf","da":"https://www.ema.europa.eu/da/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_da.pdf","de":"https://www.ema.europa.eu/de/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_de.pdf","et":"https://www.ema.europa.eu/et/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_et.pdf","el":"https://www.ema.europa.eu/el/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_hr.pdf","it":"https://www.ema.europa.eu/it/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_sv.pdf","is":"https://www.ema.europa.eu/is/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_is.pdf","no":"https://www.ema.europa.eu/no/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-1-4-september-2025-prac_no.pdf"}},
    {"id":"70315","name":"PRAC recommendations on signals adopted at the 1-4 September 2025 PRAC meeting","type":"prac-recommendation","status":"Adopted","consultation_date":"","first_published_date":"2025-09-29T13:42:44Z","last_updated_date":"2025-09-29T13:42:44Z","reference_number":"EMA/PRAC/271798/2025","document_url":"https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-1-4-september-2025-prac-meeting_en.pdf"},
    {"id":"70256","name":"Submission of comments on Reflection paper on patient experience data (EMA/CHMP/PRAC/268899/2025)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-09-29T12:00:00Z","last_updated_date":"2025-09-29T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/submission-comments-reflection-paper-patient-experience-data-ema-chmp-prac-268899-2025_en.xlsx"},
    {"id":"70327","name":"Minutes of the HMPC meeting 7-9 July 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-09-29T16:03:24Z","last_updated_date":"2025-09-29T16:03:24Z","reference_number":"EMA/HMPC/244166/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-hmpc-meeting-7-9-july-2025_en.pdf"},
    {"id":"70329","name":"Agenda of the PRAC meeting 29 September - 2 October 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-09-29T16:11:36Z","last_updated_date":"2025-09-29T16:11:36Z","reference_number":"EMA/PRAC/291018/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-meeting-29-september-2-october-2025_en.pdf"},
    {"id":"70344","name":"CHMP post-authorisation summary of positive opinion for Remsima (X-149)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-09-30T10:39:38Z","last_updated_date":"2025-09-30T10:39:38Z","reference_number":"EMA/314083/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-remsima-x-149_en.pdf"},
    {"id":"70337","name":"Presentation - Engagement with industry stakeholders (M.Filancia, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:28:19Z","last_updated_date":"2025-09-30T17:28:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-engagement-industry-stakeholders-mfilancia-ema_en.pdf"},
    {"id":"70336","name":"Presentation - Support to Small and Medium Enterprises at EMA (H.Casaert, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:27:43Z","last_updated_date":"2025-09-30T17:27:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-support-small-medium-enterprises-ema-hcasaert-ema_en.pdf"},
    {"id":"70335","name":"Presentation - Engagement with academic researchers for mutual support (R.Herold, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:26:51Z","last_updated_date":"2025-09-30T17:26:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-engagement-academic-researchers-mutual-support-rherold-ema_en.pdf"},
    {"id":"70334","name":"Presentation - EMA's first public Open Door Day (M.Mavris, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:26:08Z","last_updated_date":"2025-09-30T17:26:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-first-public-open-door-day-mmavris-ema_en.pdf"},
    {"id":"70333","name":"Presentation - Reflection paper on tailored biosimilar development (S.Thirstrup, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:25:14Z","last_updated_date":"2025-09-30T17:25:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reflection-paper-tailored-biosimilar-development-sthirstrup-ema_en.pdf"},
    {"id":"70332","name":"Presentation - Overview of EMA's 30th anniversary scientific conference (S.Thirstrup, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:24:17Z","last_updated_date":"2025-09-30T17:24:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-emas-30th-anniversary-scientific-conference-sthirstrup-ema_en.pdf"},
    {"id":"70331","name":"Presentation - Introduction to the assessment of medicines in the European Union (B.Sepodes, CHMP, Infarmed)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T17:23:12Z","last_updated_date":"2025-09-30T17:23:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introduction-assessment-medicines-european-union-bsepodes-chmp-infarmed_en.pdf"},
    {"id":"70345","name":"Presentation - A newcommunication approach on medicines safety monitoring in the EU (V.Pashova, S.Cohen, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:50:57Z","last_updated_date":"2025-09-30T10:50:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-newcommunication-approach-medicines-safety-monitoring-eu-vpashova-scohen-ema_en.pdf"},
    {"id":"70347","name":"Presentation - EMA satisfaction surveys (I.Silva, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:52:57Z","last_updated_date":"2025-09-30T10:52:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-satisfaction-surveys-isilva-ema_en.pdf"},
    {"id":"70348","name":"Presentation - New GVP guidance on minimisingembryo-fetal risks of medicines (P.Bahri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:53:36Z","last_updated_date":"2025-09-30T10:53:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-gvp-guidance-minimisingembryo-fetal-risks-medicines-pbahri-ema_en.pdf"},
    {"id":"70350","name":"Presentation - CMDhreport to PCWP/HCPWP (N.Malvik, J.Vokrouhlická, CMDh)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:55:01Z","last_updated_date":"2025-09-30T10:55:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cmdhreport-pcwp-hcpwp-nmalvik-jvokrouhlicka-cmdh_en.pdf"},
    {"id":"70351","name":"Presentation - Update on EMA’s work on Patient Experience Data (R.Gonzales-Quevedo, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:56:04Z","last_updated_date":"2025-09-30T10:56:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-emas-work-patient-experience-data-rgonzales-quevedo-ema_en.pdf"},
    {"id":"70352","name":"Presentation - AI Research Priorities Survey Invitation (L.Pinheiro, A.Langston, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:57:07Z","last_updated_date":"2025-09-30T10:57:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ai-research-priorities-survey-invitation-lpinheiro-alangston-ema_en.pdf"},
    {"id":"70346","name":"Presentation - New EMA webpage on risk minimisation (P.Bahri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:51:55Z","last_updated_date":"2025-09-30T10:51:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-new-ema-webpage-risk-minimisation-pbahri-ema_en.pdf"},
    {"id":"70015","name":"Agenda - European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting on 24 September 2025","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-09-09T11:03:29Z","last_updated_date":"2025-09-30T11:04:00Z","reference_number":"EMA/240573/2025 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-ema-patients-consumers-pcwp-healthcare-professionals-hcpwp-working-parties-joint-meeting-24-september-2025_en.pdf"},
    {"id":"70365","name":"Timolol (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010432/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T14:09:23Z","last_updated_date":"2025-09-30T14:09:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/timolol-systemic-use-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_bg.pdf","es":"https://www.ema.europa.eu/es/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_cs.pdf","da":"https://www.ema.europa.eu/da/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_da.pdf","de":"https://www.ema.europa.eu/de/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_de.pdf","et":"https://www.ema.europa.eu/et/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_et.pdf","el":"https://www.ema.europa.eu/el/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_hr.pdf","it":"https://www.ema.europa.eu/it/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/psusa/timolol-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00010432-202410_sv.pdf"}},
    {"id":"70375","name":"Minutes of the CAT meeting 16-18 July 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-09-30T16:25:00Z","last_updated_date":"2025-09-30T16:25:00Z","reference_number":"EMA/CAT/315554/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-16-18-july-2025_en.pdf"},
    {"id":"70377","name":"Minutes of the CAT meeting 12-14 August 2025 - written procedure","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-09-30T16:35:11Z","last_updated_date":"2025-09-30T16:35:11Z","reference_number":"EMA/CAT/315756/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-12-14-august-2025-written-procedure_en.pdf"},
    {"id":"67554","name":"Draft guideline on the quality aspects of mRNA vaccines","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-03-31 - 2025-09-30","first_published_date":"2025-03-31T16:26:36Z","last_updated_date":"2025-03-31T16:26:36Z","reference_number":"EMA/CHMP/BWP/82416/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-mrna-vaccines_en.pdf"},
    {"id":"67559","name":"Reflection paper on a tailored clinical approach in biosimilar development","type":"other","status":"Draft: consultation closed","consultation_date":"2025-04-01 - 2025-09-30","first_published_date":"2025-04-01T14:57:00Z","last_updated_date":"2025-04-01T14:57:00Z","reference_number":"EMA/CHMP/BMWP/60916/2025","document_url":"https://www.ema.europa.eu/en/documents/other/reflection-paper-tailored-clinical-approach-biosimilar-development_en.pdf"},
    {"id":"68812","name":"Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-06-30 - 2025-09-30","first_published_date":"2025-06-18T15:55:00Z","last_updated_date":"2025-06-18T15:55:00Z","reference_number":"EMA/179449/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-new-reflection-paper-clinical-investigation-medicinal-products-treatment-systemic-sclerosis_en.pdf"},
    {"id":"69043","name":"Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-06-30 - 2025-09-30","first_published_date":"2025-06-30T11:28:13Z","last_updated_date":"2025-06-30T11:28:13Z","reference_number":"EMA/CHMP/55697/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-lessons-learned-covid-19-pandemic-scientific-considerations-non-clinical-aspects_en.pdf"},
    {"id":"70383","name":"Guideline on in-use stability testing of veterinary medicinal products","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-10-01T09:33:35Z","last_updated_date":"2025-10-01T09:33:35Z","reference_number":"EMA/CVMP/QWP/59158/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-use-stability-testing-veterinary-medicinal-products_en.pdf"},
    {"id":"40620","name":"Organisation chart: Advisory functions","type":"other","status":"unknown","consultation_date":"","first_published_date":"2013-09-16T12:00:00Z","last_updated_date":"2025-10-01T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/organisation-chart-advisory-functions_en.pdf"},
    {"id":"20142","name":"Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-02-10T17:46:00Z","last_updated_date":"2025-10-01T14:15:00Z","reference_number":"EMA/INS/PhV/129721/2024, Rev 5","document_url":"https://www.ema.europa.eu/en/documents/other/information-member-states-requirement-nomination-pharmacovigilance-phv-contact-person-national-level_en.pdf"},
    {"id":"70384","name":"Withdrawal assessment report for Nidlegy","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2025-10-01T14:18:50Z","last_updated_date":"2025-10-01T14:18:50Z","reference_number":"EMA/CHMP/169210/2025","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-nidlegy_en.pdf"},
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    {"id":"70349","name":"Presentation - CHMP feedback to PCWP and HCPWP (E. Bałkowiec-Iskra, I. Wang, CHMP)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-09-30T10:54:17Z","last_updated_date":"2025-09-30T10:54:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-chmp-feedback-pcwp-hcpwp-e-balkowiec-iskra-i-wang-chmp_en.pdf"},
    {"id":"49882","name":"EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product information","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-01-21T17:23:00Z","last_updated_date":"2025-09-16T16:40:00Z","reference_number":"EMA/772581/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/eu-implementation-guide-ig-veterinary-medicines-product-data-union-product-database-chapter-2-format-electronic-submission-veterinary-medicinal-product-information_en.pdf"},
    {"id":"70385","name":"Presentation - Actions arising from previous meeting and other updates (M. Filancia, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T09:56:23Z","last_updated_date":"2025-10-02T09:56:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-actions-arising-previous-meeting-other-updates-m-filancia-ema_en.pdf-0"},
    {"id":"70386","name":"Presentation - Union list of critical medicines – first annual update (v2.1) (S. McMahon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T09:59:55Z","last_updated_date":"2025-10-02T09:59:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-union-list-critical-medicines-first-annual-update-v21-s-mcmahon_en.pdf"},
    {"id":"70387","name":"Presentation - MSSG working group on the vulnerability assessment methodology (V.Bennett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T10:01:56Z","last_updated_date":"2025-10-02T10:01:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mssg-working-group-vulnerability-assessment-methodology-vbennett_en.pdf"},
    {"id":"70388","name":"Presentation - Update on shortage prevention and mitigation plans (SPP/SMP) pilot (M. Alcaraz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T10:05:24Z","last_updated_date":"2025-10-02T10:05:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-shortage-prevention-mitigation-plans-spp-smp-pilot-m-alcaraz_en.pdf"},
    {"id":"70391","name":"Presentation - Medical device expert panels: support to innovation (S. da Rocha Dias, M. Antunes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T10:07:40Z","last_updated_date":"2025-10-02T10:07:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medical-device-expert-panels-support-innovation-s-da-rocha-dias-m-antunes_en.pdf"},
    {"id":"70392","name":"Presentation - Regulatory/HTA interface under the HTAR–update on implementation activities (M. Berntgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T10:09:58Z","last_updated_date":"2025-10-02T10:09:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-regulatory-hta-interface-under-htar-update-implementation-activities-m-berntgen_en.pdf"},
    {"id":"70393","name":"Presentation - The ISG focus Group on regulatory science research translation (R. Herold, P. Moscariello)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T10:12:22Z","last_updated_date":"2025-10-02T10:12:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-isg-focus-group-regulatory-science-research-translation-r-herold-p-moscariello_en.pdf"},
    {"id":"70394","name":"Presentation - EMA/HMA European platform for regulatory science research-call for expression of interest (L. Barbier, R. Herold)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T10:25:10Z","last_updated_date":"2025-10-02T10:25:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-hma-european-platform-regulatory-science-research-call-expression-interest-l-barbier-r-herold_en.pdf"},
    {"id":"70396","name":"Presentation - Update on EMA’s work on patient experience data (R. Gonzalez-Quevedo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T11:06:25Z","last_updated_date":"2025-10-02T11:06:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-emas-work-patient-experience-data-r-gonzalez-quevedo_en.pdf"},
    {"id":"70397","name":"Presentation - AI research priorities survey invitation (L. Pinheiro, A. Langston, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T11:10:28Z","last_updated_date":"2025-10-02T11:10:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ai-research-priorities-survey-invitation-l-pinheiro-langston-ema_en.pdf"},
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    {"id":"70406","name":"Minutes - Enpr-EMA Coordinating Group & networks meeting - June 2025","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T13:53:40Z","last_updated_date":"2025-10-02T13:53:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-enpr-ema-coordinating-group-networks-meeting-june-2025_en.pdf"},
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    {"id":"39122","name":"Insulin and a non-insulin active substance: guidance on prevention of medication errors","type":"medication-error","status":"unknown","consultation_date":"","first_published_date":"2015-11-27T11:00:00Z","last_updated_date":"2015-11-27T11:00:00Z","reference_number":"EMA/134144/2015","document_url":"https://www.ema.europa.eu/en/documents/medication-error/insulin-non-insulin-active-substance-guidance-prevention-medication-errors_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_da.pdf","de":"https://www.ema.europa.eu/de/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_de.pdf","et":"https://www.ema.europa.eu/et/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_et.pdf","el":"https://www.ema.europa.eu/el/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medication-error/insulin-and-non-insulin-active-substance-guidance-prevention-medication-errors_sv.pdf"}},
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    {"id":"69473","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Aplidin (plitidepsin)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-07-25T09:28:40Z","last_updated_date":"2025-10-06T16:25:00Z","reference_number":"EMA/243003/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-aplidin-plitidepsin_sv.pdf"}},
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    {"id":"70462","name":"Direct healthcare professional communication (DHPC) : Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2025-10-07T10:04:30Z","last_updated_date":"2025-10-07T10:04:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-finasteride-dutasteride-new-measures-minimise-risk-suicidal-ideation_en.pdf"},
    {"id":"70463","name":"Agenda of the CVMP meeting 7-9 October 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-10-07T10:14:17Z","last_updated_date":"2025-10-07T10:14:17Z","reference_number":"EMA/322060/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-7-9-october-2025_en.pdf"},
    {"id":"5670","name":"Questions & Answers on the impact of Mutual Recognition Agreement (MRA) between the European Union and the United States as of 1st October 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-10-31T16:20:00Z","last_updated_date":"2025-10-07T10:45:00Z","reference_number":"EMA/237611/2023","document_url":"https://www.ema.europa.eu/en/documents/other/questions-answers-impact-mutual-recognition-agreement-mra-between-european-union-united-states-1st-october-2025_en.pdf"},
    {"id":"15368","name":"Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations - Revised 1st October 2025","type":"other","status":"unknown","consultation_date":"","first_published_date":"2017-07-28T12:30:00Z","last_updated_date":"2025-10-07T10:50:00Z","reference_number":"EMA/237558/2023","document_url":"https://www.ema.europa.eu/en/documents/other/qa-impact-eu-usa-mutual-recognition-agreement-marketing-authorisation-applications-relevant-variations-revised-1st-october-2025_en.pdf"},
    {"id":"48569","name":"Diflubenzuron (Salmonidae): European public MRL assessment report (EPMAR)","type":"mrl-report","status":"unknown","consultation_date":"","first_published_date":"2020-08-07T15:43:00Z","last_updated_date":"2020-08-07T15:43:00Z","reference_number":"EMA/CVMP/115336/2018 ","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/diflubenzuron-salmonidae-european-public-mrl-assessment-report-epmar_en.pdf"},
    {"id":"29143","name":"Double-stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the Israel acute-paralysis virus (bees): European public MRL report","type":"mrl-report","status":"Adopted","consultation_date":"","first_published_date":"2013-07-25T12:00:00Z","last_updated_date":"2013-07-25T12:00:00Z","reference_number":"EMA/CVMP/430890/2013","document_url":"https://www.ema.europa.eu/en/documents/mrl-report/double-stranded-ribonucleic-acid-homologous-viral-ribonucleic-acid-coding-part-coat-protein-part-intergenic-region-israel-acute-paralysis-virus-bees-european-public-mrl-report_en.pdf"},
    {"id":"6707","name":"Opinion of the CVMP on the establishment of MRL: Double-stranded ribonucleic acid homologous to viral ribonucleic acid coding for part of the coat protein and part of the intergenic region of the  Israel Acute Paralysis Virus","type":"mrl-opinion","status":"Adopted","consultation_date":"","first_published_date":"2013-07-30T19:00:00Z","last_updated_date":"2013-07-30T19:00:00Z","reference_number":"EMA/CVMP/594122/2012","document_url":"https://www.ema.europa.eu/en/documents/mrl-opinion/opinion-cvmp-establishment-mrl-double-stranded-ribonucleic-acid-homologous-viral-ribonucleic-acid-coding-part-coat-protein-part-intergenic-region-israel-acute-paralysis-virus_en.pdf"},
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    {"id":"70481","name":"Minutes of the CHMP written procedure 18-21 August 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-10-07T16:51:10Z","last_updated_date":"2025-10-07T16:51:10Z","reference_number":"EMA/CHMP/285053/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-written-procedure-18-21-august-2025_en.pdf"},
    {"id":"70490","name":"European Medicines Agency mid-year report 2025 (January-June 2025)","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-10-08T10:54:52Z","last_updated_date":"2025-10-08T10:54:52Z","reference_number":"EMA/283452/2025","document_url":"https://www.ema.europa.eu/en/documents/report/european-medicines-agency-mid-year-report-2025-january-june-2025_en.pdf"},
    {"id":"68824","name":"Union Product Database (UPD) - Quick guide for UPD notifications via the user interface and via email ","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-19T09:25:36Z","last_updated_date":"2025-10-08T15:13:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/union-product-database-upd-quick-guide-upd-notifications-user-interface-email_en.pdf"},
    {"id":"70506","name":"European Medicines Agency’s data protection notice for the TRIP digital workstation for horizon scanning and regulatory science","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-09T13:20:46Z","last_updated_date":"2025-10-09T13:20:46Z","reference_number":"EMA/321117/2015","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-trip-digital-workstation-horizon-scanning-regulatory-science_en.pdf"},
    {"id":"70514","name":"Comirnaty : 2.4 non-clinical overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-09T15:59:12Z","last_updated_date":"2025-10-09T15:59:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comirnaty-24-non-clinical-overview_en.zip"},
    {"id":"70516","name":"Spikevax : Module 2.4 non-clinical overview","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-09T16:03:52Z","last_updated_date":"2025-10-09T16:03:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/spikevax-module-24-non-clinical-overview_en.zip"},
    {"id":"70522","name":"Direct healthcare professional communication (DHPC): Caspofungin: Avoid use of polyacrylonitrile membranes during continuous renal replacement therapy","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2025-10-09T17:19:28Z","last_updated_date":"2025-10-09T17:19:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-caspofungin-avoid-use-polyacrylonitrile-membranes-during-continuous-renal-replacement-therapy_en.pdf"},
    {"id":"48555","name":"Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products","type":"opinion-on-any-scientific-matter","status":"unknown","consultation_date":"","first_published_date":"2020-08-06T13:04:00Z","last_updated_date":"2025-10-10T08:26:00Z","reference_number":"EMA/409815/2020 Rev.23","document_url":"https://www.ema.europa.eu/en/documents/opinion-any-scientific-matter/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders-applicants-chmp-opinion-article-53-regulation-ec-no-726-2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf"},
    {"id":"70523","name":"ICH M14 guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise real-world data for safety assessment of medicines Step 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-10-10T08:30:49Z","last_updated_date":"2025-10-10T08:30:49Z","reference_number":"EMA/CHMP/ICH/155061/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m14-guideline-general-principles-planning-designing-analysing-reporting-non-interventional-studies-utilise-real-world-data-safety-assessment-medicines-step-5_en.pdf"},
    {"id":"25861","name":"Presentation - The summary-of-product-characteristics guideline and paediatric aspects","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2013-01-21T18:25:00Z","last_updated_date":"2025-10-10T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-summary-product-characteristics-guideline-paediatric-aspects_en.pdf"},
    {"id":"70451","name":"Presentation -  Product data submission & bulk edit made easy (M. Fernández Gómez, V. Lipucci Di Paola)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-06T11:27:53Z","last_updated_date":"2025-10-10T11:11:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-product-data-submission-bulk-edit-made-easy-m-fernandez-gomez-v-lipucci-di-paola_en.pdf"},
    {"id":"70524","name":"CVMP summary of positive opinion for Vaxxitek HVT+IBD+H5","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-10-10T14:00:00Z","last_updated_date":"2025-10-10T14:00:00Z","reference_number":"EMA/CVMP/307532/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vaxxitek-hvtibdh5_en.pdf"},
    {"id":"70525","name":"CVMP summary of positive opinion for Lenivia","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-10-10T14:00:00Z","last_updated_date":"2025-10-10T14:00:00Z","reference_number":"EMA/CVMP/308157/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-lenivia_en.pdf"},
    {"id":"70526","name":"HMPC meeting report on European Union herbal monographs, guidelines and other activities - 22-24 September 2025","type":"committee-report","status":"Adopted","consultation_date":"","first_published_date":"2025-10-10T14:29:23Z","last_updated_date":"2025-10-10T14:29:23Z","reference_number":"EMA/HMPC/313955/2025","document_url":"https://www.ema.europa.eu/en/documents/committee-report/hmpc-meeting-report-european-union-herbal-monographs-guidelines-other-activities-22-24-september-2025_en.pdf"},
    {"id":"69915","name":"Applications for new human medicines under evaluation: September 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-09-01T13:46:56Z","last_updated_date":"2025-09-01T13:46:56Z","reference_number":"EMA/283011/2025","document_url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-september-2025_en.xlsx"},
    {"id":"70527","name":"Applications for new human medicines under evaluation: October 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-10-10T14:42:23Z","last_updated_date":"2025-10-10T14:42:23Z","reference_number":"EMA/322049/2025","document_url":"https://www.ema.europa.eu/en/documents/report/applications-new-human-medicines-under-evaluation-october-2025_en.xlsx"},
    {"id":"69377","name":"Quarter-based selective dry cow therapy 141(1)(i) procedure - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-07-18T13:36:13Z","last_updated_date":"2025-10-13T12:50:00Z","reference_number":"EMA/CVMP/224794/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/quarter-based-selective-dry-cow-therapy-1411i-procedure-timetable-procedure_en.pdf"},
    {"id":"70534","name":"Agenda of the CHMP meeting 13-16 October 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-10-13T13:21:57Z","last_updated_date":"2025-10-13T13:21:57Z","reference_number":"EMA/CHMP/307616/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-13-16-october-2025_en.pdf"},
    {"id":"70535","name":"Annex to agenda of the CHMP meeting 13-16 October 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-10-13T13:24:10Z","last_updated_date":"2025-10-13T13:24:10Z","reference_number":"EMA/CHMP/309305/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/annex-agenda-chmp-meeting-13-16-october-2025_en.xlsx"},
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    {"id":"31439","name":"Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list ","type":"other","status":"unknown","consultation_date":"","first_published_date":"2009-02-18T01:00:00Z","last_updated_date":"2025-10-13T11:42:00Z","reference_number":"EMA/123352/2004 Rev. 16","document_url":"https://www.ema.europa.eu/en/documents/other/call-comments-veterinary-dictionary-drug-regulatory-activities-veddra-standard-list_en.pdf"},
    {"id":"16074","name":"Timetable: Post-authorisation measure (PAM) assessed by PRAC","type":"other","status":"unknown","consultation_date":"","first_published_date":"2015-07-02T16:15:00Z","last_updated_date":"2025-10-14T10:00:00Z","reference_number":"EMA/403287/2015 Rev.10","document_url":"https://www.ema.europa.eu/en/documents/other/timetable-post-authorisation-measure-pam-assessed-prac_en.xlsx"},
    {"id":"13188","name":"Timetable: Type II variation and worksharing application alternative monthly assessment","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T14:00:00Z","last_updated_date":"2025-10-14T10:01:00Z","reference_number":"EMA/577387/2016 Rev.8","document_url":"https://www.ema.europa.eu/en/documents/other/timetable-type-ii-variation-worksharing-application-alternative-monthly-assessment_en.xlsx"},
    {"id":"25658","name":"Timetable: Type II variation and worksharing application monthly assessment","type":"other","status":"unknown","consultation_date":"","first_published_date":"2016-12-19T14:00:00Z","last_updated_date":"2025-10-14T10:01:01Z","reference_number":"EMA/577385/2016 Rev.12","document_url":"https://www.ema.europa.eu/en/documents/other/timetable-type-ii-variation-worksharing-application-monthly-assessment_en.xlsx"},
    {"id":"70536","name":"Agenda - PDCO agenda of the 14-17 October 2025 meeting","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-10-14T10:04:37Z","last_updated_date":"2025-10-14T10:04:37Z","reference_number":"EMA/PDCO/309627/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-14-17-october-2025-meeting_en.xlsx"},
    {"id":"63302","name":"Agenda - Medicine Shortages (SPOC) Working Party meeting on 22 May 2024","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2024-05-22T15:12:25Z","last_updated_date":"2024-05-22T15:12:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-22-may-2024_en.pdf"},
    {"id":"69305","name":"Agenda - Medicine Shortages (SPOC) Working Party meeting on 14 July 2025","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-07-16T09:57:05Z","last_updated_date":"2025-07-16T09:57:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-14-july-2025_en.pdf"},
    {"id":"70032","name":"Agenda - Medicine Shortages (SPOC) Working Party meeting on 10 September 2025","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-09-10T08:46:49Z","last_updated_date":"2025-09-10T16:49:38Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-10-september-2025_en.pdf"},
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    {"id":"70720","name":"Presentation - Session 2: Uncertainty quantification methods for complex models used in drug development and (or) regulatory approval (A.Hooker)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:49:23Z","last_updated_date":"2025-10-21T10:49:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-uncertainty-quantification-methods-complex-models-used-drug-development-or-regulatory-approval-ahooker_en.pdf"},
    {"id":"70721","name":"Presentation - Session 3: An industry perspective on high impact QSP and QST model applications  in clinical drug development in rare diseases (A.Sher)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:50:48Z","last_updated_date":"2025-10-21T10:50:48Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-industry-perspective-high-impact-qsp-qst-model-applications-clinical-drug-development-rare-diseases-asher_en.pdf"},
    {"id":"70722","name":"Presentation - Session 3: Experience with software platforms qualification for mechanistic modelsfor agent-based modelling approaches; UISS case (F.Pappalardo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:52:00Z","last_updated_date":"2025-10-21T10:52:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-experience-software-platforms-qualification-mechanistic-modelsfor-agent-based-modelling-approaches-uiss-case-fpappalardo_en.pdf"},
    {"id":"70723","name":"Presentation - Session 3: Opportunities for application of PBPK models in special populations and different modalities (L. deZwart)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:52:55Z","last_updated_date":"2025-10-21T10:52:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-opportunities-application-pbpk-models-special-populations-different-modalities-l-dezwart_en.pdf"},
    {"id":"70724","name":"Presentation - Session 3: The landscape of QSP modelling and Virtual Population From current to best practice (A. Kulesza)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:53:41Z","last_updated_date":"2025-10-21T10:53:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-landscape-qsp-modelling-virtual-population-current-best-practice-kulesza_en.pdf"},
    {"id":"70725","name":"Presentation - Session 4: Cross-industry feedback in implementation of regulatory guidance on mechanistic models; case studies, gaps and challenges (P. Sharma)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:54:32Z","last_updated_date":"2025-10-21T10:54:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-cross-industry-feedback-implementation-regulatory-guidance-mechanistic-models-case-studies-gaps-challenges-p-sharma_en.pdf"},
    {"id":"70726","name":"Presentation - Session 4: Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development (F. Musuamba Tshinanu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:55:22Z","last_updated_date":"2025-10-21T10:55:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-guideline-assessment-reporting-mechanistic-models-used-context-model-informed-drug-development-f-musuamba-tshinanu_en.pdf"},
    {"id":"70727","name":"Presentation - Session 4: PBBM Qualification and Guidance - key challenges and emerging opportunities (C. Mackie)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:56:24Z","last_updated_date":"2025-10-21T10:56:24Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-pbbm-qualification-guidance-key-challenges-emerging-opportunities-c-mackie_en.pdf"},
    {"id":"70728","name":"Presentation - Session 4: Shaping the path forward - advancing mechanistic models for regulatory use (H. Zhu)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:57:33Z","last_updated_date":"2025-10-21T10:57:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-shaping-path-forward-advancing-mechanistic-models-regulatory-use-h-zhu_en.pdf"},
    {"id":"70708","name":"Presentation - Session 1: Pharma industry PBPK perspective on the EMA qualification framework (N. Parrott)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:38:09Z","last_updated_date":"2025-10-21T10:38:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-pharma-industry-pbpk-perspective-ema-qualification-framework-n-parrott_en.pdf"},
    {"id":"70709","name":"Presentation - Session 1: Considerations for qualification of Physiologically Based Biopharmaceutics Models - Beyond the EMA framework (X. Pepin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:39:50Z","last_updated_date":"2025-10-21T10:39:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-considerations-qualification-physiologically-based-biopharmaceutics-models-beyond-ema-framework-x-pepin_en.pdf"},
    {"id":"70717","name":"Presentation - Session 1: Software Verification, Validation, and Qualification of Open Source M&S Software (S.Schaller)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:46:53Z","last_updated_date":"2025-10-21T10:46:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-software-verification-validation-qualification-open-source-ms-software-sschaller_en.pdf"},
    {"id":"70718","name":"Presentation - Session 2: A regulatory perspective on performance verification of mechanistic models - application to PBPK-based DDI predictions (P. Colin)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T10:47:56Z","last_updated_date":"2025-10-21T10:47:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-regulatory-perspective-performance-verification-mechanistic-models-application-pbpk-based-ddi-predictions-p-colin_en.pdf"},
    {"id":"67255","name":"Agenda - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment October 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-03-25T15:15:29Z","last_updated_date":"2025-10-21T11:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-hma-ema-multi-stakeholder-workshop-reporting-qualification-mechanistic-models-regulatory-assessment-october-2025_en.pdf"},
    {"id":"70730","name":"P/0367/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mepolizumab (Nucala), (EMEA-000069-PIP01-07-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T11:23:12Z","last_updated_date":"2025-10-21T11:23:12Z","reference_number":"EMA/465524/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0367-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-mepolizumab-nucala-emea-000069-pip01-07-m09_en.pdf"},
    {"id":"70281","name":"Azithromycin Article-31 referral - Changes to the use of antibiotic azithromycin","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-09-25T15:18:10Z","last_updated_date":"2025-10-21T12:00:00Z","reference_number":"EMA/165709/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_en.pdf-0","translations":{"bg":"https://www.ema.europa.eu/bg/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_bg.pdf","es":"https://www.ema.europa.eu/es/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_cs.pdf","da":"https://www.ema.europa.eu/da/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_da.pdf","de":"https://www.ema.europa.eu/de/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_de.pdf","et":"https://www.ema.europa.eu/et/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_et.pdf","el":"https://www.ema.europa.eu/el/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_hr.pdf","it":"https://www.ema.europa.eu/it/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/referral/azithromycin-article-31-referral-changes-use-antibiotic-azithromycin_sv.pdf"}},
    {"id":"70681","name":"P/0365/2024 : EMA decision of 25 October 2024 on acceptance of a modification of an agreed paediatric investigation plan for mRNA encoding for the linked NTD and RBD domains of the spike glycoprotein of SARS-CoV-2 (mRNA-1283), (EMEA- 003426-PIP01-23-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:45:58Z","last_updated_date":"2025-10-21T15:45:58Z","reference_number":"EMA/482481/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0365-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-mrna-encoding-linked-ntd-rbd-domains-spike-glycoprotein-sars-cov-2-mrna-1283-emea-003426-pip01-23_en.pdf"},
    {"id":"70686","name":"P/0359/2024 : EMA decisio of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for brensocatib, (EMEA- 002905-PIP01-20-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:51:06Z","last_updated_date":"2025-10-21T15:51:06Z","reference_number":"EMA/481253/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0359-2024-ema-decisio-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-brensocatib-emea-002905-pip01-20-m01_en.pdf"},
    {"id":"70682","name":"P/0364/2024 : EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for pridopidine (hydrochloride), (EMEA-003174-PIP01-21-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:48:27Z","last_updated_date":"2025-10-21T15:48:27Z","reference_number":"EMA/482304/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0364-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-pridopidine-hydrochloride-emea-003174-pip01-21-m02_en.pdf"},
    {"id":"70683","name":"P/0360/2024 : EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for fidrisertib, (EMEA- 003133-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:49:19Z","last_updated_date":"2025-10-21T15:49:19Z","reference_number":"EMA/481452/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0360-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-fidrisertib-emea-003133-pip01-21-m01_en.pdf"},
    {"id":"70735","name":"P/0382/2024: EMA decision of 31 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for lebrikizumab (Ebglyss), (EMEA-002536-PIP01-18-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T14:48:20Z","last_updated_date":"2025-10-21T14:48:20Z","reference_number":"EMA/480694/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0382-2024-ema-decision-31-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-lebrikizumab-ebglyss-emea-002536-pip01-18-m04_en.pdf"},
    {"id":"70736","name":"P/0370/2024 : EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ustekinumab (Stelara), (EMEA-000311-PIP03-11-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:07:10Z","last_updated_date":"2025-10-21T15:07:10Z","reference_number":"EMA/465525/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0370-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-ustekinumab-stelara-emea-000311-pip03-11-m07_en.pdf"},
    {"id":"70738","name":"P/0376/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for posaconazole (Noxafil), (EMEA-000468-PIP02-12-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:21:12Z","last_updated_date":"2025-10-21T15:21:12Z","reference_number":"EMA/465528/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0376-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-posaconazole-noxafil-emea-000468-pip02-12-m09_en.pdf"},
    {"id":"70739","name":"P/0375/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (EMEA-001075-PIP04-15-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:25:04Z","last_updated_date":"2025-10-21T15:25:04Z","reference_number":"EMA/484740/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0375-2024-ema-decision-24-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-romosozumab-emea-001075-pip04-15-m07_en.pdf"},
    {"id":"70740","name":"P/0374/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for lomitapide (Lojuxta), (EMEA-001124-PIP01-10-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:28:59Z","last_updated_date":"2025-10-21T15:28:59Z","reference_number":"EMA/484891/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0374-2024-ema-decision-24-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-lomitapide-lojuxta-emea-001124-pip01-10-m06_en.pdf"},
    {"id":"70741","name":"P/0381/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for ceftolozane / tazobactam (Zerbaxa) (EMEA-001142-PIP02-16-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T16:08:39Z","last_updated_date":"2025-10-21T16:08:39Z","reference_number":"EMA/484870/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0381-2024-ema-decision-24-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-ceftolozane-tazobactam-zerbaxa-emea-001142-pip02-16-m02_en.pdf"},
    {"id":"70742","name":"P/0354/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for upadacitinib (Rinvoq), (EMEA-001741-PIP01-14-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T16:14:36Z","last_updated_date":"2025-10-21T16:14:36Z","reference_number":"EMA/443930/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0354-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-upadacitinib-rinvoq-emea-001741-pip01-14-m08_en.pdf"},
    {"id":"9533","name":"CVMP summary of positive opinion for MiPet Easecto","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2017-10-06T02:00:00Z","last_updated_date":"2017-10-06T02:00:00Z","reference_number":"EMA/CVMP/618926/2017","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-mipet-easecto_en.pdf"},
    {"id":"70743","name":"P/0383/2024: EMA decision of 24 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant human A disintegrin and metalloprotease with thrombospondin type-1 Motifs 13 (Adzynma), (EMEA-001160- PIP01-11-M05)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T17:17:23Z","last_updated_date":"2025-10-21T17:17:23Z","reference_number":"EMA/484938/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0383-2024-ema-decision-24-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-human-disintegrin-metalloprotease-thrombospondin-type-1-motifs-13-adzynma-emea-001160_en.pdf"},
    {"id":"70744","name":"P/0353/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP07-20-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T17:25:12Z","last_updated_date":"2025-10-21T17:25:12Z","reference_number":"EMA/443829/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0353-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-dupilumab-dupixent-emea-001501-pip07-20-m02_en.pdf"},
    {"id":"70745","name":"P/0355/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for vamorolone (Agamree), (EMEA-001794-PIP02-16-M09)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T17:31:03Z","last_updated_date":"2025-10-21T17:31:03Z","reference_number":"EMA/444192/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0355-2024-ema-decision-25-october-2024-acceptance-modification-agreed-paediatric-investigation-plan-vamorolone-agamree-emea-001794-pip02-16-m09_en.pdf"},
    {"id":"70685","name":"P/0377/2024 : EMA decision of 24 October 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dazukibart (EMEA-003089-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:50:15Z","last_updated_date":"2025-10-21T15:50:15Z","reference_number":"EMA/484648/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0377-2024-ema-decision-24-october-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-dazukibart-emea-003089-pip02-23_en.pdf"},
    {"id":"70678","name":"P/0379/2024 : EMA decision of 25 October 2024 on agreement of a paediatric investigation plan and on granting of a deferral and on the granting of a waiver for recombinant varicella zoster virus glycoprotein E adjuvanted (CRV-101) (EMEA-003526-PIP01-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-10-21T15:41:49Z","last_updated_date":"2025-10-21T15:41:49Z","reference_number":"EMA/465557/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0379-2024-ema-decision-25-october-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-varicella-zoster-virus-glycoprotein-e-adjuvanted-crv-101-emea-003526_en.pdf"},
    {"id":"70679","name":"P/0373/2024 : EMA decision of 25 October 2024 on agreement of a PIP and on granting of deferral and waiver for 3,3-Dimethyl-N-(6-methyl-5-{[2-(1-methyl-1H-pyrazol-4-yl)pyridine-4- yl]oxy}pyridine-2-yl)-2-oxopyrrolidine-1-carboxamide hydrochloride hydrate ","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-21T15:43:17Z","last_updated_date":"2025-10-21T15:43:17Z","reference_number":"EMA/480695/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0373-2024-ema-decision-25-october-2024-agreement-pip-granting-deferral-waiver-33-dimethyl-n-6-methyl-5-2-1-methyl-1h-pyrazol-4-ylpyridine-4-yloxypyridine-2-yl-2-oxopyrrolidine-1-carboxamide_en.pdf"},
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    {"id":"63957","name":"Highlights from the fifth European Medicines Agency (EMA) and the Association of the European Self-Care Industry (AESGP) bilateral meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-07-09T09:25:47Z","last_updated_date":"2024-07-09T09:25:47Z","reference_number":"EMA/187499/2024","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-fifth-european-medicines-agency-ema-association-european-self-care-industry-aesgp-bilateral-meeting_en.pdf"},
    {"id":"69697","name":"Highlights 8th EMA-EFPIA bilateral meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-08-12T14:16:57Z","last_updated_date":"2025-08-12T14:16:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-8th-ema-efpia-bilateral-meeting_en.pdf"},
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    {"id":"52120","name":"Clinical Trial Information System (CTIS) structured data form - Notifications, Annual Safety Report (ASR) and results","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2021-07-29T10:40:00Z","last_updated_date":"2025-10-23T16:27:00Z","reference_number":"EMA/297654/2021","document_url":"https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-notifications-results_en.xlsx"},
    {"id":"61603","name":"Concept paper on the establishment of a guideline on the development and manufacture of human medicinal products specifically designed for phage therapy","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-12-22 - 2024-03-31","first_published_date":"2023-12-22T15:16:45Z","last_updated_date":"2023-12-22T15:16:45Z","reference_number":"EMA/CHMP/BWP/486838/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-establishment-guideline-development-manufacture-human-medicinal-products-specifically-designed-phage-therapy_en.pdf"},
    {"id":"70661","name":"Presentation : Unlocking PMS API potential: Edit functionality training for MAHs","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-20T11:31:13Z","last_updated_date":"2025-10-20T11:31:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-unlocking-pms-api-potential-edit-functionality-training-mahs_en.pdf"},
    {"id":"70801","name":"Annex I - Briefing document - molecule-independent device bridging approach (MIDBA)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T10:00:21Z","last_updated_date":"2025-10-24T10:00:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/annex-i-briefing-document-molecule-independent-device-bridging-approach-midba_en.pdf"},
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    {"id":"70805","name":"Meeting report - Workshop on a tailored clinical approach in biosimilar Development","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T11:13:58Z","last_updated_date":"2025-10-24T11:13:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-workshop-tailored-clinical-approach-biosimilar-development_en.pdf"},
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    {"id":"70811","name":"Presentation - Risk-appropriate manufacturing for personalized gene editing: lessons from Baby KJ (V. Almendro & S. Kassim, Danaher Corporation)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T12:15:05Z","last_updated_date":"2025-10-24T12:15:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-risk-appropriate-manufacturing-personalized-gene-editing-lessons-baby-kj-v-almendro-s-kassim-danaher-corporation_en.pdf"},
    {"id":"70812","name":"Presentation - Leveraging data via platform principles in gene editing (M. Lehmicke, Alliance for Regenerative Medicine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T12:18:15Z","last_updated_date":"2025-10-24T12:18:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-leveraging-data-platform-principles-gene-editing-m-lehmicke-alliance-regenerative-medicine_en.pdf"},
    {"id":"70813","name":"Presentation - Challenges in development of in vivo gene editing therapeutics (K. M. Wood, Intellia Therapeutics)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T12:23:06Z","last_updated_date":"2025-10-24T12:23:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-challenges-development-vivo-gene-editing-therapeutics-k-m-wood-intellia-therapeutics_en.pdf"},
    {"id":"70814","name":"Presentation - Base editing opportunities for platform development (L. Barrera, Beam Therapeutics)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T12:25:51Z","last_updated_date":"2025-10-24T12:25:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-base-editing-opportunities-platform-development-l-barrera-beam-therapeutics_en.pdf"},
    {"id":"70815","name":"Presentation - Modular platform for in vivo LNP formulated prime editors targeting rare genetic diseases of the liver (A. Anzalone, Prime Medicine)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T12:32:04Z","last_updated_date":"2025-10-24T12:32:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-modular-platform-vivo-lnp-formulated-prime-editors-targeting-rare-genetic-diseases-liver-anzalone-prime-medicine_en.pdf"},
    {"id":"70816","name":"Presentation - Arbor biotechnologies challenges in developing gene editing medicines (P. Stetkiewicz, Arbor Biotechnologies)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T12:34:31Z","last_updated_date":"2025-10-24T12:34:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-arbor-biotechnologies-challenges-developing-gene-editing-medicines-p-stetkiewicz-arbor-biotechnologies_en.pdf"},
    {"id":"70819","name":"Minutes of the PRAC meeting 1-4 September 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-10-24T14:04:25Z","last_updated_date":"2025-10-24T14:04:25Z","reference_number":"EMA/PRAC/326133/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-1-4-september-2025_en.pdf"},
    {"id":"70824","name":"Highlights - Second EMA/COCIR bilateral meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-10-24T17:12:12Z","last_updated_date":"2025-10-24T17:12:12Z","reference_number":"EMA/465345/2024","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-second-ema-cocir-bilateral-meeting_en.pdf"},
    {"id":"68960","name":"ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-06-25 - 2025-10-24","first_published_date":"2025-06-25T13:00:18Z","last_updated_date":"2025-06-25T13:00:18Z","reference_number":"EMA/CHMP/ICH/178042/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-m4qr2-guideline-common-technical-document-registration-pharmaceuticals-human-use-quality-step-2b_en.pdf"},
    {"id":"70826","name":"PRAC recommendations on signals adopted at the 29 September - 2 October 2025 PRAC meeting","type":"prac-recommendation","status":"Adopted","consultation_date":"","first_published_date":"2025-10-27T08:18:41Z","last_updated_date":"2025-10-27T08:18:41Z","reference_number":"EMA/PRAC/303684/2025","document_url":"https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-29-september-2-october-2025-prac-meeting_en.pdf"},
    {"id":"70849","name":"Withdrawal assessment report for Fanskya","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2025-10-27T15:17:52Z","last_updated_date":"2025-10-27T15:17:52Z","reference_number":"EMA/CAT/271921/2025","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-fanskya_en.pdf"},
    {"id":"69844","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Fanskya (Mozafancogene autotemcel)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-08-22T12:00:11Z","last_updated_date":"2025-10-27T15:20:00Z","reference_number":"EMA/270385/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-fanskya-mozafancogene-autotemcel_sv.pdf"}},
    {"id":"70854","name":"Agenda of the PRAC meeting 27 - 30 October 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-10-27T17:27:56Z","last_updated_date":"2025-10-27T17:27:56Z","reference_number":"EMA/PRAC/316561/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-prac-meeting-27-30-october-2025_en.pdf"},
    {"id":"70580","name":"Agenda - ACT EU multi-stakeholder platform annual meeting - October 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-10-15T16:58:18Z","last_updated_date":"2025-10-28T14:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-act-eu-multi-stakeholder-platform-annual-meeting-october-2025_en.pdf"},
    {"id":"32833","name":"Overview of comments received on 'Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) No. 1394/2007'","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2010-02-23T00:09:21Z","last_updated_date":"2010-02-23T00:09:21Z","reference_number":"EMA/CAT/106109/2010","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/overview-comments-received-procedural-advice-provision-scientific-recommendation-classification-advanced-therapy-medicinal-products-accordance-article-17-regulation-ec-no-1394-2007_en.pdf"},
    {"id":"70893","name":"Direct healthcare professional communication (DHPC) : Lenalidomide Mylan (lenalidomide): potential for damaged capsules and precautionary handling measures","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T09:15:12Z","last_updated_date":"2025-10-29T09:15:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-lenalidomide-mylan-lenalidomide-potential-damaged-capsules-precautionary-handling-measures_en.pdf"},
    {"id":"67907","name":"Business process description for pharmacovigilance ","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-04-22T16:14:15Z","last_updated_date":"2025-10-29T09:45:00Z","reference_number":"EMA/182390/2024","document_url":"https://www.ema.europa.eu/en/documents/other/business-process-description-pharmacovigilance_en.pdf"},
    {"id":"70596","name":"Work plan for the ADRA temporary Working Party (tWP) 2025-2026","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-16T13:11:48Z","last_updated_date":"2025-10-16T13:11:48Z","reference_number":"EMA/CVMP/314118/2025","document_url":"https://www.ema.europa.eu/en/documents/other/work-plan-adra-temporary-working-party-twp-2025-2026_en.pdf"},
    {"id":"70597","name":"Mandate, objectives and rules of procedure for the CVMP temporary Working Party (tWP) on the ADRA project","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-16T13:17:06Z","last_updated_date":"2025-10-16T13:17:06Z","reference_number":"EMA/CVMP/182608/2025","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-rules-procedure-cvmp-temporary-working-party-twp-adra-project_en.pdf"},
    {"id":"68531","name":"Agenda - EMA roundtable with stakeholders on the 20th anniversary of the SME regulation","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-02T15:22:46Z","last_updated_date":"2025-10-29T16:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-roundtable-stakeholders-20th-anniversary-sme-regulation_en.pdf"},
    {"id":"70904","name":"Presentation - The EU Pharmaceutical Reform (O.Solomon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:10:17Z","last_updated_date":"2025-10-29T15:10:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-pharmaceutical-reform-osolomon_en.pdf"},
    {"id":"70903","name":"Presentation - EU support to small and medium-sized enterprises (SMEs) (E.Batta)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T14:53:14Z","last_updated_date":"2025-10-29T14:53:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eu-support-small-medium-sized-enterprises-smes-ebatta_en.pdf"},
    {"id":"70905","name":"Presentation - European Investment Bank in life sciences (D.Burduja)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:11:56Z","last_updated_date":"2025-10-29T15:11:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-investment-bank-life-sciences-dburduja_en.pdf"},
    {"id":"70906","name":"Presentation - European Innovation Council (EIC) support for (SME) innovators (O.Symmons)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:13:21Z","last_updated_date":"2025-10-29T15:13:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-innovation-council-eic-support-sme-innovators-osymmons_en.pdf"},
    {"id":"70908","name":"Presentation - Life science incubator perspectives (C.Bergstrom)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:15:57Z","last_updated_date":"2025-10-29T15:15:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-life-science-incubator-perspectives-cbergstrom_en.pdf"},
    {"id":"70907","name":"Presentation - Private funding perspectives (S.Slootweg)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:15:08Z","last_updated_date":"2025-10-29T15:15:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-private-funding-perspectives-sslootweg_en.pdf"},
    {"id":"70909","name":"Presentation - Patients' organisation perspectives (V.Hivert)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:17:04Z","last_updated_date":"2025-10-29T15:17:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-organisation-perspectives-vhivert_en.pdf"},
    {"id":"70910","name":"Presentation - Achievements of EMA’s SME Regulation (L.Enes)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:18:02Z","last_updated_date":"2025-10-29T15:18:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-achievements-emas-sme-regulation-lenes_en.pdf"},
    {"id":"70912","name":"Presentation - EMA small and medium-sized enterprises (SMEs) survey (T.Ballotti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:20:39Z","last_updated_date":"2025-10-29T15:20:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-small-medium-sized-enterprises-smes-survey-tballotti_en.pdf"},
    {"id":"70913","name":"Presentation - AKIGAI perspective (M.Cameron)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:23:59Z","last_updated_date":"2025-10-29T15:23:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-akigai-perspective-mcameron_en.pdf"},
    {"id":"70914","name":"Presentation - VetHellas perspective (A.Kachrimanidis)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:28:21Z","last_updated_date":"2025-10-29T15:28:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-vethellas-perspective-akachrimanidis_en.pdf"},
    {"id":"70915","name":"Presentation - Veterinary Medicines’ perspective (E.Vecino)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:29:16Z","last_updated_date":"2025-10-29T15:29:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-medicines-perspective-evecino_en.pdf"},
    {"id":"70916","name":"Presentation - Human Medicines' perspective (A.Natz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:34:51Z","last_updated_date":"2025-10-29T15:34:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-human-medicines-perspective-anatz_en.pdf"},
    {"id":"70911","name":"Presentation - SME and Innovation Support in the European Medicines Regulatory Network (L.O'Dwyer)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-10-29T15:19:12Z","last_updated_date":"2025-10-29T15:19:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-sme-innovation-support-european-medicines-regulatory-network-lodwyer_en.pdf"},
    {"id":"70932","name":"Glipizide : List of nationally authorised medicinal products - PSUSA/00001535/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-30T13:08:23Z","last_updated_date":"2025-10-30T13:08:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/glipizide-list-nationally-authorised-medicinal-products-psusa-00001535-202501_en.pdf"},
    {"id":"70931","name":"Dermatan sulfate : List of nationally authorised medicinal products - PSUSA/00000957/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-30T12:49:21Z","last_updated_date":"2025-10-30T12:49:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/dermatan-sulfate-list-nationally-authorised-medicinal-products-psusa-00000957-202411_en.pdf"},
    {"id":"70531","name":"Questions and answers on the refusal of the marketing authorisation for Syfovre (pegcetacoplan)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-10-10T17:53:42Z","last_updated_date":"2025-10-30T17:15:00Z","reference_number":"EMA/432931/2024","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-refusal-marketing-authorisation-syfovre-pegcetacoplan_sv.pdf"}},
    {"id":"70954","name":"Recommendations on eligibility to PRIME scheme adopted at the CHMP meeting of 13-16 October 2025","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2025-10-31T08:00:37Z","last_updated_date":"2025-10-31T08:00:37Z","reference_number":"EMA/317115/2025","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/recommendations-eligibility-prime-scheme-adopted-chmp-meeting-13-16-october-2025_en.pdf"},
    {"id":"70941","name":"PRAC statistics: November 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-10-31T12:00:00Z","last_updated_date":"2025-10-31T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/prac-statistics-november-2025_en.pdf"},
    {"id":"68567","name":"Agenda - Public webinar on shortages: putting patients first","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-04T10:59:17Z","last_updated_date":"2025-10-31T16:20:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-public-webinar-shortages-putting-patients-first_en.pdf"},
    {"id":"67864","name":"Concept paper for the development of a reflection paper on the assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-04-16 - 2025-10-31","first_published_date":"2025-04-16T09:21:49Z","last_updated_date":"2025-04-16T09:21:49Z","reference_number":"EMA/CVMP/ERA/75412/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-assessment-public-health-risks-related-antimicrobial-resistance-acquired-environment-resulting-use-veterinary-medicinal-product_en.pdf"},
    {"id":"68849","name":"Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-06-20 - 2025-10-31","first_published_date":"2025-06-20T08:40:35Z","last_updated_date":"2025-06-20T08:40:35Z","reference_number":"EMA/CVMP/ERA/499198/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-guideline-methodology-environmental-risk-assessment-ectoparasiticidal-vmps-cats-dogs_en.pdf"},
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    {"id":"67050","name":"Questions and answers on the withdrawal of application to change the marketing authorisation for Dupixent (dupilumab) (II-0083)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-02-28T11:51:01Z","last_updated_date":"2025-11-07T11:40:00Z","reference_number":"EMA/68277/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_bg.pdf","es":"https://www.ema.europa.eu/es/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_cs.pdf","da":"https://www.ema.europa.eu/da/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_da.pdf","de":"https://www.ema.europa.eu/de/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_de.pdf","et":"https://www.ema.europa.eu/et/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_et.pdf","el":"https://www.ema.europa.eu/el/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_hr.pdf","it":"https://www.ema.europa.eu/it/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-dupixent-dupilumab-ii-0083_sv.pdf"}},
    {"id":"71048","name":"Withdrawal assessment report for Dupixant (II-0083)","type":"withdrawal-report","status":"unknown","consultation_date":"","first_published_date":"2025-11-07T11:39:15Z","last_updated_date":"2025-11-07T11:39:15Z","reference_number":"EMA/67383/2025","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-dupixant-ii-0083_en.pdf"},
    {"id":"52118","name":"Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, (Multi trial) substantial modification, non-substantial modification, and Request for information (RFI)","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2021-07-29T10:40:00Z","last_updated_date":"2025-11-07T15:51:00Z","reference_number":"EMA/343883/2021","document_url":"https://www.ema.europa.eu/en/documents/template-form/clinical-trial-information-system-ctis-structured-data-form-initial-application-additional-member-state-concerned-substantial-modification-non-substantial-modification_en.xlsx"},
    {"id":"71050","name":"CVMP summary of positive opinion for Vaxxinact H5","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-07T15:00:00Z","last_updated_date":"2025-11-07T15:00:00Z","reference_number":"EMA/CVMP/341546/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-vaxxinact-h5_en.pdf"},
    {"id":"71051","name":"CVMP summary of positive opinion for Ecovaxxin MS","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-07T15:00:00Z","last_updated_date":"2025-11-07T15:00:00Z","reference_number":"EMA/CVMP/347145/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-ecovaxxin-ms_en.pdf"},
    {"id":"71052","name":"CVMP post-authorisation summary of positive opinion for Credelio, Lotimax, Credelio Plus","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-07T15:00:00Z","last_updated_date":"2025-11-07T15:00:00Z","reference_number":"EMADOC-1700519818-2563727","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-credelio-lotimax-credelio-plus_en.pdf"},
    {"id":"71053","name":"CVMP post-authorisation summary of positive opinion for Frontpro","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-07T15:00:00Z","last_updated_date":"2025-11-07T15:00:00Z","reference_number":"  EMADOC-1700519818-2578983","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-frontpro_en.pdf-0"},
    {"id":"71054","name":"CVMP post-authorisation summary of positive opinion for Mhyosphere PCV ID","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-07T15:00:00Z","last_updated_date":"2025-11-07T15:00:00Z","reference_number":"EMADOC-1700519818-2563533","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-mhyosphere-pcv-id_en.pdf"},
    {"id":"60467","name":"MSSG Voluntary Solidarity Mechanism","type":"other","status":"unknown","consultation_date":"","first_published_date":"2023-10-24T15:39:00Z","last_updated_date":"2025-11-07T15:54:22Z","reference_number":"EMA/323316/2023 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/other/mssg-voluntary-solidarity-mechanism_en.pdf"},
    {"id":"71055","name":"Presentation - What is a shortage,why do shortages happen,and what is their impact? (J. Garcia Burgos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:27:15Z","last_updated_date":"2025-11-10T09:27:15Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-shortagewhy-do-shortages-happenand-what-their-impact-j-garcia-burgos-ema_en.pdf"},
    {"id":"71057","name":"Presentation - What measures do EMA and national authorities take to address shortages? (E.Cormier, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:30:00Z","last_updated_date":"2025-11-10T09:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-what-measures-do-ema-national-authorities-take-address-shortages-ecormier-ema_en.pdf"},
    {"id":"71058","name":"Presentation - Examples of measures taken by EMA and national authorities to tackle shortages (M.Dias, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:30:47Z","last_updated_date":"2025-11-10T09:30:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-examples-measures-taken-ema-national-authorities-tackle-shortages-mdias-ema_en.pdf"},
    {"id":"71059","name":"Presentation - Where can patients and healthcare professionals find information on shortages? (I.Abed, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:31:39Z","last_updated_date":"2025-11-10T09:31:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-where-can-patients-healthcare-professionals-find-information-shortages-iabed-ema_en.pdf"},
    {"id":"71060","name":"Presentation - Recommendations on shortage management (A.la Santos, BEUC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:32:46Z","last_updated_date":"2025-11-10T09:32:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-recommendations-shortage-management-ala-santos-beuc_en.pdf"},
    {"id":"71061","name":"Presentation - Shortages: putting patients first (J.Batista, PharmD PGEU)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:33:46Z","last_updated_date":"2025-11-10T09:33:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-shortages-putting-patients-first-jbatista-pharmd-pgeu_en.pdf"},
    {"id":"71062","name":"Presentation - Shortages: Role of patient organisations in supporting/informing patients & EPF recommendations (S.Jouan, EPF)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:35:19Z","last_updated_date":"2025-11-10T09:35:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-shortages-role-patient-organisations-supporting-informing-patients-epf-recommendations-sjouan-epf_en.pdf"},
    {"id":"71063","name":"Presentation -The role of patients in preventing and managing medicine shortages (M.Podesta, EFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:36:08Z","last_updated_date":"2025-11-10T09:36:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-role-patients-preventing-managing-medicine-shortages-mpodesta-efa_en.pdf"},
    {"id":"71056","name":"Presentation - Addressing shortages: A key priority for the European Commission (L.Geslin, EC)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T09:28:19Z","last_updated_date":"2025-11-10T09:28:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-addressing-shortages-key-priority-european-commission-lgeslin-ec_en.pdf"},
    {"id":"71071","name":"Agenda of the CHMP meeting 10-13 November 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-11-10T14:40:43Z","last_updated_date":"2025-11-10T14:40:43Z","reference_number":"EMA/CHMP/331479/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-10-13-november-2025_en.pdf"},
    {"id":"71072","name":"Annex to agenda of the CHMP meeting 10-13 November 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-11-10T14:42:38Z","last_updated_date":"2025-11-10T14:42:38Z","reference_number":"EMA/CHMP/335242/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/annex-agenda-chmp-meeting-10-13-november-2025_en.xlsx"},
    {"id":"71077","name":"Direct healthcare professional communication (DHPC) : Libtayo (cemiplimab) 350 mg concentrate for solution for infusion: Batch / lot number and expiry date may become illegible following sanitisation and wiping of vial label","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T16:25:05Z","last_updated_date":"2025-11-10T16:25:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-libtayo-cemiplimab-350-mg-concentrate-solution-infusion-batch-lot-number-expiry-date-may-become-illegible-following-sanitisation-wiping-vial-label_en.pdf"},
    {"id":"71082","name":"Agenda - PDCO agenda of the 11-14 November 2025 meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-11-11T10:31:49Z","last_updated_date":"2025-11-11T10:31:49Z","reference_number":"EMA/PDCO/338749/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-pdco-agenda-11-14-november-2025-meeting_en.xlsx"},
    {"id":"70976","name":"Agenda - Combination products operational group, MD stream, 7 November 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-11-03T14:20:09Z","last_updated_date":"2025-11-03T14:20:09Z","reference_number":"EMA/324489/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-combination-products-operational-group-md-stream-7-november-2025_en.pdf"},
    {"id":"70977","name":"Agenda - Combination products operational group, IVD stream, 4 November 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-11-03T14:22:12Z","last_updated_date":"2025-11-03T14:22:12Z","reference_number":"EMA/324488/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-combination-products-operational-group-ivd-stream-4-november-2025_en.pdf"},
    {"id":"70196","name":"Agenda - First EMA-HMA multi-stakeholder forum on EudraVigilance and signal detection","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-09-19T17:11:05Z","last_updated_date":"2025-10-29T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-first-ema-hma-multi-stakeholder-forum-eudravigilance-signal-detection_en.pdf"},
    {"id":"64914","name":"Agenda - Second EMA/COCIR bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2024-09-18T16:41:36Z","last_updated_date":"2024-09-18T16:41:36Z","reference_number":"EMA/313158/2024","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-ema-cocir-bilateral-meeting_en.pdf"},
    {"id":"71084","name":"Presentation - Session 1 - Involving patients in clinical trial design - where can we innovate? (A.Hursey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T10:52:37Z","last_updated_date":"2025-11-11T10:52:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-involving-patients-clinical-trial-design-where-can-we-innovate-ahursey_en.pdf"},
    {"id":"71085","name":"Presentation - Session 1 - Update on EMA’s work on patient experience data (PED) (R. Gonzalez-Quevedo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T10:57:05Z","last_updated_date":"2025-11-11T10:57:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-1-update-emas-work-patient-experience-data-ped-r-gonzalez-quevedo_en.pdf"},
    {"id":"71087","name":"Presentation - Session 2 - Concrete examples of trials approved with innovative design(s) (O. Della Pasqua)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T11:02:31Z","last_updated_date":"2025-11-11T11:02:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-2-concrete-examples-trials-approved-innovative-designs-o-della-pasqua_en.pdf"},
    {"id":"71088","name":"Presentation - Session 3 - Digital innovation in healthcare: challenges and possibilities (J. Van Eldere)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T11:06:41Z","last_updated_date":"2025-11-11T11:06:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-digital-innovation-healthcare-challenges-possibilities-j-van-eldere_en.pdf"},
    {"id":"71089","name":"Presentation - Session 3 - Opportunities for the European health data space to change clinical trial recruitment (A. Pitcher)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T11:11:00Z","last_updated_date":"2025-11-11T11:11:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-3-opportunities-european-health-data-space-change-clinical-trial-recruitment-pitcher_en.pdf"},
    {"id":"71090","name":"Presentation - Session 4 - Safeguarding participants while driving innovation (A. Van Scharen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T11:14:43Z","last_updated_date":"2025-11-11T11:14:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-safeguarding-participants-while-driving-innovation-van-scharen_en.pdf"},
    {"id":"70762","name":"Agenda - 20th industry stakeholder platform - operation of European Union (EU) pharmacovigilance","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-10-22T15:36:00Z","last_updated_date":"2025-11-11T11:25:00Z","reference_number":"EMA/147010/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-20th-industry-stakeholder-platform-operation-european-union-eu-pharmacovigilance_en.pdf"},
    {"id":"71091","name":"Presentation - Session 4 - Informed consent: challenges in complex and novel trials, information of trial subjects (F. Houÿez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-11T11:18:07Z","last_updated_date":"2025-11-11T11:18:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-session-4-informed-consent-challenges-complex-novel-trials-information-trial-subjects-f-houyez_en.pdf"},
    {"id":"55220","name":"Faecal microbiota transplantation EU-IN Horizon Scanning Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2022-06-13T14:19:00Z","last_updated_date":"2025-11-11T17:22:00Z","reference_number":"EMA/204935/2022 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/faecal-microbiota-transplantation-eu-horizon-scanning-report_en.pdf"},
    {"id":"69015","name":"Agenda - Second EMA and European Society of Cardiology (ESC) bilateral meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-06-27T14:49:32Z","last_updated_date":"2025-11-11T11:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-second-ema-european-society-cardiology-esc-bilateral-meeting_en.pdf"},
    {"id":"69016","name":"Highlights - Second EMA and European Society of Cardiology (ESC) bilateral meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-06-27T14:53:01Z","last_updated_date":"2025-11-11T11:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-second-ema-european-society-cardiology-esc-bilateral-meeting_en.pdf"},
    {"id":"66578","name":"Nanotechnology-based medicinal products for human use EU-IN Horizon Scanning Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-02-03T16:46:08Z","last_updated_date":"2025-11-11T11:55:29Z","reference_number":"EMA/20989/2025 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/nanotechnology-based-medicinal-products-human-use-eu-horizon-scanning-report_en.pdf"},
    {"id":"70224","name":"Engineered living materials for in situ production of therapeutics - EU-IN Horizon Scanning Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-09-23T13:41:37Z","last_updated_date":"2025-11-11T11:57:14Z","reference_number":"EMA/291569/2025 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/engineered-living-materials-situ-production-therapeutics-eu-horizon-scanning-report_en.pdf"},
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    {"id":"55013","name":"CHMP summary of positive opinion for Sitagliptin / Metformin hydrochloride Accord","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2022-05-20T15:00:00Z","last_updated_date":"2025-11-13T09:45:00Z","reference_number":"EMA/264071/2022","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-sitagliptin-metformin-hydrochloride-accord_en.pdf"},
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    {"id":"71107","name":"Agenda - Medicine Shortages (SPOC) Working Party 11 November 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-11-12T15:41:15Z","last_updated_date":"2025-11-13T13:39:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-11-november-2025_en.pdf"},
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    {"id":"71139","name":"Presentation - Harnessing large language models to improve antimicrobial use monitoring in dairy farming (B. Koppe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:02:04Z","last_updated_date":"2025-11-13T15:02:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-harnessing-large-language-models-improve-antimicrobial-use-monitoring-dairy-farming-b-koppe_en.pdf"},
    {"id":"71140","name":"Presentation - Interoperable big data for veterinary prescription and antimicrobial use (I. Almeida)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:03:25Z","last_updated_date":"2025-11-13T15:03:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-interoperable-big-data-veterinary-prescription-antimicrobial-use-i-almeida_en.pdf"},
    {"id":"71141","name":"Presentation - Use of antimicrobials in companion animals from 133 German veterinary practices (R. Merle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:05:14Z","last_updated_date":"2025-11-13T15:05:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-antimicrobials-companion-animals-133-german-veterinary-practices-r-merle_en.pdf"},
    {"id":"71142","name":"Presentation - A.I. governance in veterinary big data: why pursue it and how to achieve it (P. Harms)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:06:59Z","last_updated_date":"2025-11-13T15:06:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ai-governance-veterinary-big-data-why-pursue-it-how-achieve-it-p-harms_en.pdf"},
    {"id":"71143","name":"Presentation - How company roles are changing with AI (R. Gross)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:08:37Z","last_updated_date":"2025-11-13T15:08:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-how-company-roles-are-changing-ai-r-gross_en.pdf"},
    {"id":"71144","name":"Presentation - AI@MPA toolbox: AI for medicines regulations (S. Doyle)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:10:34Z","last_updated_date":"2025-11-13T15:10:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-aimpa-toolbox-ai-medicines-regulations-s-doyle_en.pdf"},
    {"id":"71145","name":"Presentation - Leveraging unified big data and AI: insights from VetCompass (N. Kennedy)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:11:31Z","last_updated_date":"2025-11-13T15:11:31Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-leveraging-unified-big-data-ai-insights-vetcompass-n-kennedy_en.pdf"},
    {"id":"71146","name":"Presentation - SPC reader: unlocking veterinary product data (L. Romero Fernández de V.)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:12:54Z","last_updated_date":"2025-11-13T15:12:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-spc-reader-unlocking-veterinary-product-data-l-romero-fernandez-de-v_en.pdf"},
    {"id":"71147","name":"Presentation - Introducing the care framework:  development of a data-driven quality improvement project (M. Erwood)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:16:18Z","last_updated_date":"2025-11-13T15:16:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introducing-care-framework-development-data-driven-quality-improvement-project-m-erwood_en.pdf"},
    {"id":"71148","name":"Presentation - Data for environment, climate, and animal health (C. Maia, S. Blesic)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T15:17:58Z","last_updated_date":"2025-11-13T15:17:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-data-environment-climate-animal-health-c-maia-s-blesic_en.pdf"},
    {"id":"25175","name":"Guideline on the development of new medicinal products for the treatment of Crohn’s disease - Revision 2","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2018-07-23T11:44:59Z","last_updated_date":"2018-07-23T11:44:59Z","reference_number":"CPMP/EWP/2284/99 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-crohns-disease-revision-2_en.pdf"},
    {"id":"71151","name":"Overview of comments received on ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2025-11-13T16:27:23Z","last_updated_date":"2025-11-13T16:27:23Z","reference_number":"EMA/316356/2025","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-e21-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials_en.pdf"},
    {"id":"7949","name":"Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2009-09-23T02:00:00Z","last_updated_date":"2025-11-14T09:20:00Z","reference_number":"EMA/CVMP/519714/2009 Rev. 62","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/substances-considered-not-falling-within-scope-regulation-ec-no-470-2009-regard-residues-veterinary-medicinal-products-foodstuffs-animal-origin_en.pdf"},
    {"id":"71160","name":"Questions and answers on classification of a product as intended for a limited market according to Article 4(29) and/or eligibility for authorisation according to Article 23 (Applications for limited markets)","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T09:39:00Z","last_updated_date":"2025-11-14T09:39:00Z","reference_number":"EMA/CVMP/33689/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/questions-answers-classification-product-intended-limited-market-according-article-429-or-eligibility-authorisation-according-article-23-applications-limited-markets_en.pdf"},
    {"id":"50274","name":"Reflection paper on classification of a product as intended for a limited market and eligibility for authorisation according to Article 23 (Applications for limited markets)","type":"regulatory-procedural-guideline","status":"Draft: consultation closed","consultation_date":"2021-02-25 - 2021-05-15","first_published_date":"2021-02-25T15:25:00Z","last_updated_date":"2021-02-25T15:25:00Z","reference_number":"EMA/CVMP/235292/2020","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-classification-product-intended-limited-market-eligibility-authorisation-according-article-23-applications-limited-markets_en.pdf"},
    {"id":"14930","name":"Joint scientific report of the European Centre for Disease Prevention and Control, European Food Safety Authority and European Medicines Agency on meticillin-resistant Staphylococcus aureus (MRSA) in livestock, companion animals and food","type":"report","status":"Adopted","consultation_date":"","first_published_date":"2009-06-16T02:00:00Z","last_updated_date":"2009-06-16T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/joint-scientific-report-european-centre-disease-prevention-control-european-food-safety-authority-european-medicines-agency-meticillin-resistant-staphylococcus-aureus-mrsa-livestock-companion-animals_en.pdf"},
    {"id":"71163","name":"Minutes of the CVMP meeting 7-9 October 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T10:09:52Z","last_updated_date":"2025-11-14T10:09:52Z","reference_number":"EMA/352482/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cvmp-meeting-7-9-october-2025_en.pdf"},
    {"id":"71166","name":"Medicine shortage communication (MSC) : Bronchitol, 40 mg inhalation powder, hard capsules: ongoing shortage","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T10:37:09Z","last_updated_date":"2025-11-14T10:37:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/medicine-shortage-communication-msc-bronchitol-40-mg-inhalation-powder-hard-capsules-ongoing-shortage_en.pdf"},
    {"id":"71158","name":"CHMP post-authorisation summary of positive opinion for Koselugo X-18-G","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/CHMP/348586/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-koselugo-x-18-g_en.pdf"},
    {"id":"71159","name":"CHMP summary of positive opinion for Osqay","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/CHMP/355239/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-osqay_en.pdf"},
    {"id":"71098","name":"CHMP summary of positive opinion for Ondibta","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/337755/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-ondibta_en.pdf"},
    {"id":"71099","name":"CHMP post-authorisation summary of positive opinion for Minjuvi (EMAVR0000255975)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMADOC-1700519818-2579167","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-minjuvi-emavr0000255975_en.pdf"},
    {"id":"71138","name":"Withdrawal letter: Nurzigma","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T15:00:04Z","last_updated_date":"2025-11-14T15:00:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-nurzigma_en.pdf"},
    {"id":"71114","name":"CHMP summary of positive opinion for Dawnzera","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/CHMP/303939/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-dawnzera_en.pdf"},
    {"id":"69477","name":"CHMP summary of positive opinion for Aqneursa","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-07-25T10:23:08Z","last_updated_date":"2025-11-14T12:35:57Z","reference_number":"EMA/114031/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-aqneursa_en.pdf"},
    {"id":"71116","name":"CHMP summary of positive opinion for Enzalutamide Accordpharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/245975/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-enzalutamide-accordpharma_en.pdf"},
    {"id":"71173","name":"CHMP post-authorisation summary of positive opinion for Xerava (EMAVR0000265697)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T11:08:10Z","last_updated_date":"2025-11-14T11:08:10Z","reference_number":"EMADOC-1700519818-2615480","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-xerava-emavr0000265697_en.pdf"},
    {"id":"71157","name":"CHMP summary of positive opinion for VacPertagen","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T17:15:43Z","last_updated_date":"2025-11-14T17:15:43Z","reference_number":"EMA/CHMP/354843/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-vacpertagen_en.pdf"},
    {"id":"71117","name":"CHMP summary of positive opinion for Inluriyo","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/CHMP/354855/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-inluriyo_en.pdf"},
    {"id":"71178","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Insulin Aspart Injection (insulin aspart)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T11:52:27Z","last_updated_date":"2025-11-14T11:52:27Z","reference_number":"EMA/356296/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-insulin-aspart-injection-insulin-aspart_en.pdf"},
    {"id":"71176","name":"Withdrawal letter: Insulin Aspart Injection","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T11:51:26Z","last_updated_date":"2025-11-14T11:51:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-insulin-aspart-injection_en.pdf"},
    {"id":"71131","name":"CHMP post-authorisation summary of positive opinion for Veyvondi (EMAVR0000264863)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMADOC-1700519818-2554896","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-veyvondi-emavr0000264863_en.pdf"},
    {"id":"71134","name":"CHMP summary of positive opinion for Teduglutide Viatris","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/358510/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-teduglutide-viatris_en.pdf"},
    {"id":"71175","name":"CHMP summary of positive opinion for Waskyra","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T11:36:52Z","last_updated_date":"2025-11-14T11:36:52Z","reference_number":"EMA/343921/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-waskyra_en.pdf"},
    {"id":"71172","name":"CHMP summary of positive opinion for GalenVita","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-11-14T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/354268/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-galenvita_en.pdf"},
    {"id":"70944","name":"Highlights - European Medicines Agency (EMA) and European Association of Urology (EAU) bilateral meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-10-30T15:21:18Z","last_updated_date":"2025-11-14T11:20:31Z","reference_number":"EMA/342496/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/highlights-european-medicines-agency-ema-european-association-urology-eau-bilateral-meeting_en.pdf"},
    {"id":"71170","name":"Questions and answers on the withdrawal of application for the marketing authorisation of Ohtuvayre (ensifentrine)","type":"medicine-qa","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T10:49:24Z","last_updated_date":"2025-11-14T10:49:24Z","reference_number":"EMA/363153/2025","document_url":"https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-marketing-authorisation-ohtuvayre-ensifentrine_en.pdf"},
    {"id":"71169","name":"Withdrawal letter: Ohtuvayre","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-11-14T12:48:18Z","last_updated_date":"2025-11-14T12:48:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-ohtuvayre_en.pdf"},
    {"id":"67045","name":"Questions and answers on the refusal of the marketing authorisation for Kizfizo (temozolomide)","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2025-02-28T12:00:00Z","last_updated_date":"2025-11-14T12:00:00Z","reference_number":"EMA/77307/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_en.pdf","translations":{"bg":"https://www.ema.europa.eu/bg/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_bg.pdf","es":"https://www.ema.europa.eu/es/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_es.pdf","cs":"https://www.ema.europa.eu/cs/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_cs.pdf","da":"https://www.ema.europa.eu/da/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_da.pdf","de":"https://www.ema.europa.eu/de/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_de.pdf","et":"https://www.ema.europa.eu/et/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_et.pdf","el":"https://www.ema.europa.eu/el/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_el.pdf","fr":"https://www.ema.europa.eu/fr/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_fr.pdf","hr":"https://www.ema.europa.eu/hr/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_hr.pdf","it":"https://www.ema.europa.eu/it/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_it.pdf","lv":"https://www.ema.europa.eu/lv/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_lv.pdf","lt":"https://www.ema.europa.eu/lt/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_lt.pdf","hu":"https://www.ema.europa.eu/hu/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_hu.pdf","mt":"https://www.ema.europa.eu/mt/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_mt.pdf","nl":"https://www.ema.europa.eu/nl/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_nl.pdf","pl":"https://www.ema.europa.eu/pl/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_pl.pdf","pt":"https://www.ema.europa.eu/pt/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_pt.pdf","ro":"https://www.ema.europa.eu/ro/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_ro.pdf","sk":"https://www.ema.europa.eu/sk/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_sk.pdf","sl":"https://www.ema.europa.eu/sl/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_sl.pdf","fi":"https://www.ema.europa.eu/fi/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_fi.pdf","sv":"https://www.ema.europa.eu/sv/documents/smop-initial/questions-answers-refusal-marketing-authorisation-kizfizo-temozolomide_sv.pdf"}},
    {"id":"70619","name":"Questions and answers on the refusal of the marketing authorisation for Rezurock (belumosudil)","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-10-17T09:54:53Z","last_updated_date":"2025-11-14T15:29:16Z","reference_number":"EMA/335553/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-rezurock-belumosudil_en.pdf"},
    {"id":"70075","name":"Agenda - European Medicine Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2025-09-12T14:39:27Z","last_updated_date":"2025-11-11T10:38:00Z","reference_number":"EMA/103325/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicine-agency-ema-european-association-study-diabetes-easd-bilateral-meeting_en.pdf"},
    {"id":"70761","name":"Highlights - European Medicine Agency (EMA) and European Association for the Study of Diabetes (EASD) bilateral meeting","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-10-22T15:08:35Z","last_updated_date":"2025-11-14T10:37:00Z","reference_number":"EMA/322020/2025","document_url":"https://www.ema.europa.eu/en/documents/other/highlights-european-medicine-agency-ema-european-association-study-diabetes-easd-bilateral-meeting_en.pdf"},
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    {"id":"71396","name":"Presentation - Update on eAFand eCTD v4.0 in the CP (K. Puusaari, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T14:46:35Z","last_updated_date":"2025-11-28T14:46:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-eafand-ectd-v40-cp-k-puusaari-ema_en.pdf"},
    {"id":"71397","name":"Presentation - Update on ongoing initiatives in the centralised procedure (F. Day, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T14:49:54Z","last_updated_date":"2025-11-28T14:49:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-ongoing-initiatives-centralised-procedure-f-day-ema_en.pdf"},
    {"id":"71398","name":"Presentation - EMA’s implementation of IPA programme (K. Rugo; M. Hendrix, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T14:50:47Z","last_updated_date":"2025-11-28T14:50:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-emas-implementation-ipa-programme-k-rugo-m-hendrix-ema_en.pdf"},
    {"id":"71399","name":"Presentation - EMA SEND Proof-of-concept study (C. Van Doesum-Wolters, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T14:52:19Z","last_updated_date":"2025-11-28T14:52:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-send-proof-concept-study-c-van-doesum-wolters-ema_en.pdf"},
    {"id":"71400","name":"Presentation - Update on QRD template revision and ‘Key information section’ (KIS) survey (A. Skarlatos, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T14:53:58Z","last_updated_date":"2025-11-28T14:53:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-qrd-template-revision-key-information-section-kis-survey-skarlatos-ema_en.pdf"},
    {"id":"71401","name":"Presentation - Update on Patient Experience Data (PED) (R. Gonzalez-Quevedo, EMA),","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T14:55:16Z","last_updated_date":"2025-11-28T14:55:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-patient-experience-data-ped-r-gonzalez-quevedo-ema_en.pdf"},
    {"id":"71405","name":"Spikevax : Module 2.6 non-clinical summary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T15:28:34Z","last_updated_date":"2025-11-28T15:28:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/spikevax-module-26-non-clinical-summary_en.zip"},
    {"id":"68998","name":"Comirnaty : 2.6. non-clinical summary","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-06-30T18:22:11Z","last_updated_date":"2025-11-28T15:35:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/comirnaty-26-non-clinical-summary_en.zip"},
    {"id":"57525","name":"Guidance for stepwise PIPs (sPIPs)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2023-02-06T13:46:00Z","last_updated_date":"2025-11-28T16:07:00Z","reference_number":"EMA/768685/2022","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-stepwise-pips-spips_en.pdf"},
    {"id":"71407","name":"Vaccine platform technology master file (vPTMF) submission letter template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T16:40:05Z","last_updated_date":"2025-11-28T16:40:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/vaccine-platform-technology-master-file-vptmf-submission-letter-template_en.docx"},
    {"id":"71408","name":"Vaccine antigen master file (VAMF) submission letter template","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2025-11-28T16:40:22Z","last_updated_date":"2025-11-28T16:40:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/vaccine-antigen-master-file-vamf-submission-letter-template_en.docx"},
    {"id":"71410","name":"Minutes - Management Board meeting: 2 October 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-12-01T10:34:10Z","last_updated_date":"2025-12-01T10:34:10Z","reference_number":"EMA/MB/313357/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-management-board-meeting-2-october-2025_en.pdf"},
    {"id":"71418","name":"Presentation - ADR Data Quality Framework - Development, summary and next steps (T.Paternoster-Howe, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T11:51:46Z","last_updated_date":"2025-12-01T11:51:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-adr-data-quality-framework-development-summary-next-steps-tpaternoster-howe-ema_en.pdf"},
    {"id":"71421","name":"Presentation - Industry perspective on signal management (J.Zanetic, Teva;  A.Kubavat, Sandoz; R. Van Eemeren, Amgen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T11:55:12Z","last_updated_date":"2025-12-01T11:55:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-industry-perspective-signal-management-jzanetic-teva-akubavat-sandoz-r-van-eemeren-amgen_en.pdf"},
    {"id":"71423","name":"Presentation - Achievements and impact of the Medical Literature Monitoring (MLM) service - A retrospective review of the first 10 years (T.Paternoster-Howe, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T11:58:20Z","last_updated_date":"2025-12-01T11:58:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-achievements-impact-medical-literature-monitoring-mlm-service-retrospective-review-first-10-years-tpaternoster-howe-ema_en.pdf"},
    {"id":"71425","name":"Presentation - HMA-EMA catalogues of real-world data (RWD) sources and studies (K-C. Deli, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T12:00:34Z","last_updated_date":"2025-12-01T12:00:34Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hma-ema-catalogues-real-world-data-rwd-sources-studies-k-c-deli-ema_en.pdf"},
    {"id":"71426","name":"Presentation - Real world evidence update (A. Segec, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T12:03:16Z","last_updated_date":"2025-12-01T12:03:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-real-world-evidence-update-segec-ema_en.pdf"},
    {"id":"71427","name":"Presentation - Update on the EU-good pharmacovigilance practices (EU-GVP) (P. Bahri, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T12:04:50Z","last_updated_date":"2025-12-01T12:04:50Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-eu-good-pharmacovigilance-practices-eu-gvp-p-bahri-ema_en.pdf"},
    {"id":"71428","name":"Presentation - Termination of the pilot of signal detection in EudraVigilance by marketing authorisation holders (MAHs) (S. Eleni, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T12:06:13Z","last_updated_date":"2025-12-01T12:06:13Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-termination-pilot-signal-detection-eudravigilance-marketing-authorisation-holders-mahs-s-eleni-ema_en.pdf"},
    {"id":"71429","name":"Presentation - AI in pharmacovigilance – EMA update (L. Pinheiro, J. Durand, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T12:07:17Z","last_updated_date":"2025-12-01T12:07:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ai-pharmacovigilance-ema-update-l-pinheiro-j-durand-ema_en.pdf"},
    {"id":"71431","name":"Presentation - The use of EV data and common inspection findings (Dr.Jahn, Paul-Ehrlich-Institut)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T13:21:09Z","last_updated_date":"2025-12-01T13:21:09Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-use-ev-data-common-inspection-findings-drjahn-paul-ehrlich-institut_en.pdf"},
    {"id":"71432","name":"Presentation - SMART Methods Working Group: Harnessing collective expertise to strengthen signal detection (C.Zaccaria, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T13:22:42Z","last_updated_date":"2025-12-01T13:22:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-smart-methods-working-group-harnessing-collective-expertise-strengthen-signal-detection-czaccaria-ema_en.pdf"},
    {"id":"71433","name":"Presentation - AI in pharmacovigilane - Industry perspective","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T13:24:06Z","last_updated_date":"2025-12-01T13:24:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ai-pharmacovigilane-industry-perspective_en.pdf"},
    {"id":"71434","name":"Presentation - CIOMS Working Group XIV upcoming report on AI in pharmacovigilance (J.Durand, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T13:25:30Z","last_updated_date":"2025-12-01T13:25:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-cioms-working-group-xiv-upcoming-report-ai-pharmacovigilance-jdurand-ema_en.pdf"},
    {"id":"71435","name":"Presentation - Updates on EudraVigilance (J.Caetano, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-01T13:26:22Z","last_updated_date":"2025-12-01T13:26:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-eudravigilance-jcaetano-ema_en.pdf"},
    {"id":"65528","name":"Dengue Tetravalent Vaccine (Live, Attenuated) Takeda : Procedural steps taken and scientific information after authorisation (archive)","type":"outside-EU-steps-after","status":"unknown","consultation_date":"","first_published_date":"2024-11-04T10:53:10Z","last_updated_date":"2025-12-01T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-steps-after/dengue-tetravalent-vaccine-live-attenuated-takeda-procedural-steps-taken-scientific-information-after-authorisation-archive_en.pdf"},
    {"id":"71443","name":"Draft agenda – Workshop between notified bodies and expert panels","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-12-01T16:55:35Z","last_updated_date":"2025-12-01T16:55:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/draft-agenda-workshop-between-notified-bodies-expert-panels_en.pdf"},
    {"id":"53154","name":"Guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Signal Management","type":"regulatory-procedural-guideline","status":"Adopted","consultation_date":"","first_published_date":"2021-11-18T15:30:00Z","last_updated_date":"2021-11-18T15:30:00Z","reference_number":"EMA/522332/2021","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-veterinary-good-pharmacovigilance-practices-vgvp-module-signal-management_en.pdf"},
    {"id":"71447","name":"Union Product Database (UPD) - Questions & answers: Network use","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-02T10:32:11Z","last_updated_date":"2025-12-02T10:32:11Z","reference_number":"EMA/379949/2025","document_url":"https://www.ema.europa.eu/en/documents/other/union-product-database-upd-questions-answers-network-use_en.pdf"},
    {"id":"69632","name":"Declaration of interests: Stefanie Prilla","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-08-01T15:58:39Z","last_updated_date":"2025-12-02T10:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/declaration-interests-stefanie-prilla_en.pdf"},
    {"id":"45767","name":"Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-10-22T14:37:00Z","last_updated_date":"2025-12-02T11:25:00Z","reference_number":"EMA/37991/2019 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746-tracked-changes_en.pdf"},
    {"id":"43928","name":"Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2019-02-28T12:00:00Z","last_updated_date":"2025-12-02T11:25:00Z","reference_number":"EMA/37991/2019 Rev.6","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf"},
    {"id":"71449","name":"Agenda of the CVMP meeting 2-4 December 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-12-02T11:31:29Z","last_updated_date":"2025-12-02T11:31:29Z","reference_number":"EMA/CVMP/366230/2025 – draft 3","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cvmp-meeting-2-4-december-2025_en.pdf"},
    {"id":"71450","name":"EMA/PE/0000232315: EMA decision of 19 March 2025 on the acceptance of a modification of an agreed paediatric investigation plan for spesolimab (Spevigo)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-02T11:44:17Z","last_updated_date":"2025-12-02T11:44:17Z","reference_number":"EMADOC-1700519818-1976710","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000232315-ema-decision-19-march-2025-acceptance-modification-agreed-paediatric-investigation-plan-spesolimab-spevigo_en.pdf"},
    {"id":"71451","name":"P/0388/2024: EMA decision of 8 November 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tildrakizumab (Ilumetri), (EMEA-001451-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-02T11:50:11Z","last_updated_date":"2025-12-02T11:50:11Z","reference_number":"EMA/513587/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0388-2024-ema-decision-8-november-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tildrakizumab-ilumetri-emea-001451-pip02-24_en.pdf"},
    {"id":"71452","name":"P/0387/2024: EMA decision of 8 November 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ravulizumab (Ultomiris), (EMEA-001943-PIP07-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-02T11:51:24Z","last_updated_date":"2025-12-02T11:51:24Z","reference_number":"EMA/506319/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0387-2024-ema-decision-8-november-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ravulizumab-ultomiris-emea-001943-pip07-24_en.pdf"},
    {"id":"51731","name":"Aluvia : Product information","type":"outside-EU-product-information","status":"unknown","consultation_date":"","first_published_date":"2010-01-29T16:35:00Z","last_updated_date":"2025-12-02T11:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-product-information/aluvia-product-information_en.pdf"},
    {"id":"67754","name":"Aluvia : Procedural steps taken and scientific information after opinion","type":"outside-EU-steps-after","status":"unknown","consultation_date":"","first_published_date":"2025-04-11T13:26:00Z","last_updated_date":"2025-12-02T15:56:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-steps-after/aluvia-procedural-steps-taken-scientific-information-after-opinion_en.pdf"},
    {"id":"71458","name":"SPOR & XEVMPD status update webinar – Questions and Answers","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-02T16:33:44Z","last_updated_date":"2025-12-02T16:33:44Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/spor-xevmpd-status-update-webinar-questions-answers_en.pdf"},
    {"id":"71460","name":"CAT quarterly highlights and approved ATMPs - December 2025","type":"committee-report","status":"unknown","consultation_date":"","first_published_date":"2025-12-02T16:39:46Z","last_updated_date":"2025-12-02T16:39:46Z","reference_number":"EMA/CAT/380337/2025","document_url":"https://www.ema.europa.eu/en/documents/committee-report/cat-quarterly-highlights-approved-atmps-december-2025_en.pdf"},
    {"id":"71463","name":"Agenda of the CAT meeting 3-5 December 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-12-03T09:00:00Z","last_updated_date":"2025-12-03T09:00:00Z","reference_number":"EMA/CAT/380010/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-3-5-december-2025_en.pdf"},
    {"id":"71466","name":"Tibolone : List of nationally authorised medicinal products - PSUSA/00002947/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-12-03T10:21:31Z","last_updated_date":"2025-12-03T10:21:31Z","reference_number":"EMADOC-1700519818-1987499","document_url":"https://www.ema.europa.eu/en/documents/psusa/tibolone-list-nationally-authorised-medicinal-products-psusa-00002947-202412_en.pdf"},
    {"id":"71471","name":"Keeping medicines safe: What actions can EMA take?","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-03T12:00:00Z","last_updated_date":"2025-12-03T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/keeping-medicines-safe-what-actions-can-ema-take_en.pdf"},
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    {"id":"56766","name":"Gabapentin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"71515","name":"EMA/PE/0000221709: EMA decision of 7 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for apitegromab","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:26:27Z","last_updated_date":"2025-12-05T09:26:27Z","reference_number":"EMADOC-1700519818-1736438","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000221709-ema-decision-7-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-apitegromab_en.pdf"},
    {"id":"71516","name":"EMA/PE/0000182362: EMA decision of 14 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for tildrakizumab (Ilumetri)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:33:55Z","last_updated_date":"2025-12-05T09:33:55Z","reference_number":"EMADOC-1700519818-1760793","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000182362-ema-decision-14-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-tildrakizumab-ilumetri_en.pdf"},
    {"id":"71517","name":"EMA/PE/0000183059: EMA decision of 13 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for abrocitinib (Cibinqo)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:40:48Z","last_updated_date":"2025-12-05T09:40:48Z","reference_number":"EMADOC-1700519818-1759464","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000183059-ema-decision-13-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-abrocitinib-cibinqo_en.pdf"},
    {"id":"71518","name":"EMA/PE/0000221076: EMA decision of 8 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for adrenaline (epinephrine) (EURneffy)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:42:04Z","last_updated_date":"2025-12-05T09:42:04Z","reference_number":"EMADOC-1700519818-1738916","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000221076-ema-decision-8-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-adrenaline-epinephrine-eurneffy_en.pdf"},
    {"id":"71519","name":"EMA/PE/0000183220: EMA decision of 22 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for iclepertin","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:43:01Z","last_updated_date":"2025-12-05T09:43:01Z","reference_number":"EMADOC-1700519818-1766863","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000183220-ema-decision-22-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-iclepertin_en.pdf"},
    {"id":"71520","name":"EMA/PE/0000221589: EMA decision of 25 Nov 2024 on the acceptance of a modification of an agreed PIP for split influenza virus, inactivated containing antigens equivalent to the A/H1N1 and A/H3N2-like strain, B-like strain (Victoria / Yamagata lineage)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:43:53Z","last_updated_date":"2025-12-05T09:43:53Z","reference_number":"EMADOC-1700519818-1773555","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000221589-ema-decision-25-nov-2024-acceptance-modification-agreed-pip-split-influenza-virus-inactivated-containing-antigens-equivalent-h1n1-h3n2-strain-b-strain-victoria-yamagata-lineage_en.pdf"},
    {"id":"71521","name":"EMA/PE/0000238005: EMA decision of 27 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for inebilizumab (Uplinza)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:54:25Z","last_updated_date":"2025-12-05T09:54:25Z","reference_number":"EMADOC-1700519818-1776292","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000238005-ema-decision-27-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-inebilizumab-uplinza_en.pdf"},
    {"id":"71522","name":"EMA/PE/0000238074: EMA decision of 27 November 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mitapivat (Pryrukind)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T09:55:17Z","last_updated_date":"2025-12-05T09:55:17Z","reference_number":"EMADOC-1700519818-1789262","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000238074-ema-decision-27-november-2024-acceptance-modification-agreed-paediatric-investigation-plan-mitapivat-pryrukind_en.pdf"},
    {"id":"62992","name":"All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 4","type":"other","status":"Adopted","consultation_date":"","first_published_date":"2024-04-17T10:40:00Z","last_updated_date":"2024-04-17T10:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/all-languages-annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human-use-sante-2017-11668-revision-4_en.xlsx"},
    {"id":"71523","name":"Presentation - Patient and HCP engagement highlights 2025 (M. Carr)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T11:32:27Z","last_updated_date":"2025-12-05T11:32:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-hcp-engagement-highlights-2025-m-carr_en.pdf"},
    {"id":"71525","name":"Presentation - Overview of evolution of patient and healthcare professional engagement in EMA activities (M. Mavris)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T11:34:53Z","last_updated_date":"2025-12-05T11:34:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-evolution-patient-healthcare-professional-engagement-ema-activities-m-mavris_en.pdf"},
    {"id":"71526","name":"Presentation - EMA-led RWE generation (D. Morales)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T11:36:47Z","last_updated_date":"2025-12-05T11:36:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-led-rwe-generation-d-morales_en.pdf"},
    {"id":"71524","name":"All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 5","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T11:39:00Z","last_updated_date":"2025-12-05T11:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/all-languages-annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human-use-sante-2017-11668-revision-5_en.xlsx"},
    {"id":"71528","name":"Presentation - Updates on Cancer Medicines Forum (C. Voltz-Girolt)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T11:38:37Z","last_updated_date":"2025-12-05T11:38:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-cancer-medicines-forum-c-voltz-girolt_en.pdf"},
    {"id":"71456","name":"Propylthiouracil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - 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    {"id":"68332","name":"Lidocaine (Porcine) - Summary opinion of the CVMP on the modification of maximum residue limits","type":"mrl-summary","status":"Adopted","consultation_date":"","first_published_date":"2025-05-16T15:02:04Z","last_updated_date":"2025-12-05T14:21:49Z","reference_number":"EMA/CVMP/380363/2025","document_url":"https://www.ema.europa.eu/en/documents/mrl-summary/lidocaine-porcine-summary-opinion-cvmp-modification-maximum-residue-limits_en.pdf"},
    {"id":"71530","name":"CVMP summary of positive opinion for Epizootic haemorrhagic disease vaccine (recombinant protein) Laboratorios Syva S.A.","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T14:00:00Z","last_updated_date":"2025-12-05T14:00:00Z","reference_number":"EMA/CVMP/368551/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-epizootic-haemorrhagic-disease-vaccine-recombinant-protein-laboratorios-syva-sa_en.pdf"},
    {"id":"71531","name":"CVMP summary of positive opinion for Firocoxib CP-Pharma","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T14:00:00Z","last_updated_date":"2025-12-05T14:00:00Z","reference_number":"EMA/CVMP/367445/2025","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-firocoxib-cp-pharma_en.pdf"},
    {"id":"71533","name":"CVMP post-authorisation summary of positive opinion for Dexdomitor (EMA/VRA/0000257740)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-12-05T14:00:00Z","last_updated_date":"2025-12-05T14:00:00Z","reference_number":"EMADOC-1700519818-2668331","document_url":"https://www.ema.europa.eu/en/documents/smop/cvmp-post-authorisation-summary-positive-opinion-dexdomitor-ema-vra-0000257740_en.pdf"},
    {"id":"71536","name":"Presentation - Multi-stakeholder platform 2025 activity (D. Lacombe, F. Houÿez, A. Zanoletty)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:02:47Z","last_updated_date":"2025-12-05T15:02:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-multi-stakeholder-platform-2025-activity-d-lacombe-f-houyez-zanoletty_en.pdf"},
    {"id":"71537","name":"Presentation - Accelerating Clinical Trials in the EU (ACT EU) (L. Pioppo)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:05:20Z","last_updated_date":"2025-12-05T15:05:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-accelerating-clinical-trials-eu-act-eu-l-pioppo_en.pdf"},
    {"id":"71538","name":"Presentation - A Patient’s quest to the Magical Land of Clinical Trials: Is there a Yellow Brick Road? (I. Psalti)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:06:37Z","last_updated_date":"2025-12-05T15:06:37Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patients-quest-magical-land-clinical-trials-there-yellow-brick-road-i-psalti_en.pdf"},
    {"id":"71539","name":"Presentation - Annual training 2026 (K. Immonen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:08:18Z","last_updated_date":"2025-12-05T15:08:18Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-annual-training-2026-k-immonen_en.pdf"},
    {"id":"71540","name":"Presentation - Training on Scientific Advice (L. Barbier)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:09:28Z","last_updated_date":"2025-12-05T15:09:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-training-scientific-advice-l-barbier_en.pdf"},
    {"id":"71541","name":"Presentation - EMA international engagement and activities (M. Harvey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:10:35Z","last_updated_date":"2025-12-05T15:10:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-international-engagement-activities-m-harvey_en.pdf"},
    {"id":"71542","name":"Presentation - Updates from the Cardiovascular Space (M. Holler)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:12:19Z","last_updated_date":"2025-12-05T15:12:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-cardiovascular-space-m-holler_en.pdf"},
    {"id":"71543","name":"Presentation - Aligning policies with real-world medical needs (M. Romano)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:13:43Z","last_updated_date":"2025-12-05T15:13:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-aligning-policies-real-world-medical-needs-m-romano_en.pdf"},
    {"id":"71343","name":"Agenda - 15th Industry Standing Group (ISG) meeting","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-11-26T11:05:39Z","last_updated_date":"2025-12-05T15:14:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-15th-industry-standing-group-isg-meeting_en.pdf"},
    {"id":"71544","name":"Presentation - Proposed Critical Medicines Act (V. Bennett)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:14:57Z","last_updated_date":"2025-12-05T15:14:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-proposed-critical-medicines-act-v-bennett_en.pdf"},
    {"id":"71545","name":"Presentation - Introducing to shortages topic (M. Dias)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:16:21Z","last_updated_date":"2025-12-05T15:16:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-introducing-shortages-topic-m-dias_en.pdf"},
    {"id":"71546","name":"Presentation - Union list of critical medicines - first annual update (S. McMahon)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:17:36Z","last_updated_date":"2025-12-05T15:17:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-union-list-critical-medicines-first-annual-update-s-mcmahon_en.pdf"},
    {"id":"71547","name":"Presentation - Shortage Prevention Plan and Shortage Mitigation Plan pilot (M. Alcaraz)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:19:52Z","last_updated_date":"2025-12-05T15:19:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-shortage-prevention-plan-shortage-mitigation-plan-pilot-m-alcaraz_en.pdf"},
    {"id":"71548","name":"Presentation - Ongoing critical shortages and activities (K. Kruttwig)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:21:42Z","last_updated_date":"2025-12-05T15:21:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ongoing-critical-shortages-activities-k-kruttwig_en.pdf"},
    {"id":"71549","name":"Presentation - EAHP Survey on the shortages of medicines and  medical devices (D. Makridaki)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:22:52Z","last_updated_date":"2025-12-05T15:22:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-eahp-survey-shortages-medicines-medical-devices-d-makridaki_en.pdf"},
    {"id":"71550","name":"Presentation - EMA-HMA repurposing pilot report (C. Bouygues)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:24:05Z","last_updated_date":"2025-12-05T15:24:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-ema-hma-repurposing-pilot-report-c-bouygues_en.pdf"},
    {"id":"71551","name":"Presentation - Social media campaigns (G. Gabrielli)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:25:10Z","last_updated_date":"2025-12-05T15:25:10Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-social-media-campaigns-g-gabrielli_en.pdf"},
    {"id":"71552","name":"Presentation - Gender equality in women’s health - the forgotten priority (C. de Vries)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:26:41Z","last_updated_date":"2025-12-05T15:26:41Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-gender-equality-womens-health-forgotten-priority-c-de-vries_en.pdf"},
    {"id":"71553","name":"Presentation - Communications on safety monitoring of medicines in the EU (V. Pashova, S. Cohen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:28:08Z","last_updated_date":"2025-12-05T15:28:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-communications-safety-monitoring-medicines-eu-v-pashova-s-cohen_en.pdf"},
    {"id":"71554","name":"Presentation - Medicine overviews - Feedback from patient and healthcare professional survey (C. Ester)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:29:27Z","last_updated_date":"2025-12-05T15:29:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-medicine-overviews-feedback-patient-healthcare-professional-survey-c-ester_en.pdf"},
    {"id":"71555","name":"Presentation - Update on Human Medicines Highlights (K. Immonen)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-05T15:31:26Z","last_updated_date":"2025-12-05T15:31:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-update-human-medicines-highlights-k-immonen_en.pdf"},
    {"id":"46406","name":"European Medicines Agency’s data protection notice regarding the Experts Management Tool and the handling of competing interests","type":"other","status":"unknown","consultation_date":"","first_published_date":"2020-01-10T11:11:00Z","last_updated_date":"2024-12-06T14:25:00Z","reference_number":"EMA/283094/2023 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/other/european-medicines-agencys-data-protection-notice-regarding-experts-management-tool-handling-competing-interests_en.pdf"},
    {"id":"71560","name":"Direct healthcare professional communication (DHPC) : Remsima (infliximab): New IV formulation (100 mg and 350 mg concentrate for solution for infusion) contains sorbitol and is therefore contraindicated in patients with hereditary fructose intolerance","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2025-12-08T09:12:39Z","last_updated_date":"2025-12-08T09:12:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-remsima-infliximab-new-iv-formulation-100-mg-350-mg-concentrate-solution-infusion-contains-sorbitol-therefore-contraindicated-patients-hereditary_en.pdf"},
    {"id":"71565","name":"EMA/PE/0000225184: EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for nirmatrelvir, nirmatrelvir / ritonavir ( Paxlovid)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:47:39Z","last_updated_date":"2025-12-08T10:47:39Z","reference_number":"EMADOC-1700519818-1788035","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000225184-ema-decision-6-december-2024-acceptance-modification-agreed-paediatric-investigation-plan-nirmatrelvir-nirmatrelvir-ritonavir-paxlovid_en.pdf"},
    {"id":"71566","name":"EMA/PE/0000224486: EMA decision of 5 December 2024 on the granting of a product specific waiver for amlodipine, ramipril, rosuvastatin","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:48:39Z","last_updated_date":"2025-12-08T10:48:39Z","reference_number":"EMADOC-1700519818-1792333","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000224486-ema-decision-5-december-2024-granting-product-specific-waiver-amlodipine-ramipril-rosuvastatin_en.pdf"},
    {"id":"71567","name":"EMA/PE/0000224202: EMA decision of 5 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dengue tetravalent vaccine (live, attenuated) (Qdenga)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:49:35Z","last_updated_date":"2025-12-08T10:49:35Z","reference_number":"EMADOC-1700519818-1793045","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000224202-ema-decision-5-december-2024-acceptance-modification-agreed-paediatric-investigation-plan-dengue-tetravalent-vaccine-live-attenuated-qdenga_en.pdf"},
    {"id":"71568","name":"EMA/PE/0000221803: EMA decision of 6 December 2024 on the refusal of a paediatric investigation plan and on the granting of a waiver for betula pendula pollen extract","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:50:20Z","last_updated_date":"2025-12-08T10:50:20Z","reference_number":"EMADOC-1700519818-1793589","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000221803-ema-decision-6-december-2024-refusal-paediatric-investigation-plan-granting-waiver-betula-pendula-pollen-extract_en.pdf"},
    {"id":"71573","name":"P/0393/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tulisokibart (EMEA-003556-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:54:33Z","last_updated_date":"2025-12-08T10:54:33Z","reference_number":"EMA/554343/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0393-2024-ema-decision-6-december-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tulisokibart-emea-003556-pip02-24_en.pdf"},
    {"id":"71575","name":"P/0397/2024: EMA decision of 5 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for trastuzumab deruxtecan (Enhertu), (EMEA-002978-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:57:05Z","last_updated_date":"2025-12-08T10:57:05Z","reference_number":"EMA/556006/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0397-2024-ema-decision-5-december-2024-agreement-paediatric-investigation-plan-granting-deferral-trastuzumab-deruxtecan-enhertu-emea-002978-pip02-24_en.pdf"},
    {"id":"71576","name":"P/0394/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan for 7-ethyl-10-hydroxy-camptothecin (SN-38) (EMEA-003588-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T10:58:01Z","last_updated_date":"2025-12-08T10:58:01Z","reference_number":"EMA/554382/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0394-2024-ema-decision-6-december-2024-agreement-paediatric-investigation-plan-7-ethyl-10-hydroxy-camptothecin-sn-38-emea-003588-pip01-24_en.pdf"},
    {"id":"71578","name":"P/0391/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for doruxapapogenum ralaplasmidum, (EMEA-003506-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T11:06:18Z","last_updated_date":"2025-12-08T11:06:18Z","reference_number":"EMA/552735/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0391-2024-ema-decision-6-december-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-doruxapapogenum-ralaplasmidum-emea-003506-pip01-23_en.pdf"},
    {"id":"71579","name":"P/0390/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tulisokibart, (EMEA-003556-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-08T11:10:55Z","last_updated_date":"2025-12-08T11:10:55Z","reference_number":"EMA/552717/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0390-2024-ema-decision-6-december-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-tulisokibart-emea-003556-pip01-23_en.pdf"},
    {"id":"66447","name":"Product Management Service (PMS) roadmap","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-01-24T13:27:43Z","last_updated_date":"2025-12-08T11:12:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/product-management-service-pms-roadmap_en.pdf"},
    {"id":"70021","name":"Programme - Joint HMA/EMA multi-stakeholder workshop on Patient Registries December 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-09-09T14:54:27Z","last_updated_date":"2025-12-08T16:22:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/programme-joint-hma-ema-multi-stakeholder-workshop-patient-registries-december-2025_en.pdf"},
    {"id":"71073","name":"Agenda - Quarterly System Demo Q4 2025","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-11-10T16:00:42Z","last_updated_date":"2025-12-08T15:03:03Z","reference_number":"EMA/356849/2025 Rev.3","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-quarterly-system-demo-q4-2025_en.pdf"},
    {"id":"71590","name":"Agenda of the CHMP meeting 8-11 December 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-12-08T15:01:38Z","last_updated_date":"2025-12-08T15:01:38Z","reference_number":"EMA/CHMP/347361/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-8-11-december-2025_en.pdf"},
    {"id":"71591","name":"Annex to agenda of the CHMP meeting 8-11 December 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-12-08T15:03:38Z","last_updated_date":"2025-12-08T15:03:38Z","reference_number":"EMA/CHMP/362409/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/annex-agenda-chmp-meeting-8-11-december-2025_en.xlsx"},
    {"id":"70542","name":"Agenda - HMA/EMA Annual Data Forum 2025","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2025-10-14T11:32:10Z","last_updated_date":"2025-12-08T15:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-hma-ema-annual-data-forum-2025_en.pdf"},
    {"id":"71594","name":"Addendum to Assessment report on Althaea officinalis L., radix","type":"herbal-report","status":"unknown","consultation_date":"","first_published_date":"2025-12-08T16:42:02Z","last_updated_date":"2025-12-08T16:42:02Z","reference_number":"EMA/HMPC/301260/2025","document_url":"https://www.ema.europa.eu/en/documents/herbal-report/addendum-assessment-report-althaea-officinalis-l-radix_en.pdf"},
    {"id":"71595","name":"Medicine shortage communication (MSC): Insulin lispro Sanofi (insulin lispro 100 units/ml solution for injection in cartridge and pre-filled pen)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-08T16:50:51Z","last_updated_date":"2025-12-08T16:50:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/medicine-shortage-communication-msc-insulin-lispro-sanofi-insulin-lispro-100-units-ml-solution-injection-cartridge-pre-filled-pen_en.pdf"},
    {"id":"71577","name":"P/0392/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for linaprazan glurate (EMEA-003558-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T10:59:32Z","last_updated_date":"2025-12-09T10:59:32Z","reference_number":"EMA/554255/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0392-2024-ema-decision-6-december-2024-agreement-paediatric-investigation-plan-granting-deferral-linaprazan-glurate-emea-003558-pip01-23_en.pdf"},
    {"id":"71574","name":"P/0398/2024: EMA decision of 17 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for olorofim, (EMEA-003564-PIP01-23) in","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T10:55:52Z","last_updated_date":"2025-12-09T10:55:52Z","reference_number":"EMA/587147/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0398-2024-ema-decision-17-december-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-olorofim-emea-003564-pip01-23_en.pdf"},
    {"id":"71580","name":"P/0389/2024: EMA decision of 5 Dec 2024 on the agreement of a PIP and on granting of a deferral and a waiver for 6'-([(1S,3S)-3-([5-(difluoromethoxy)-2- pyrimidinyl]amino)cyclopentyl] amino)-2H- [1,3'-bipyridin]-2-one (AZD0780) (EMEA-003580-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T11:12:58Z","last_updated_date":"2025-12-09T11:12:58Z","reference_number":"EMA/552707/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0389-2024-ema-decision-5-dec-2024-agreement-pip-granting-deferral-waiver-6-1s3s-3-5-difluoromethoxy-2-pyrimidinylaminocyclopentyl-amino-2h-13-bipyridin-2-one-azd0780-emea-003580-pip01-24_en.pdf"},
    {"id":"71569","name":"P/0396/2024: EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for gorilla adenovirus vector expressing HPV6 and HPV11 antigens (PRGN-2012), (EMEA-003592-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T10:51:27Z","last_updated_date":"2025-12-09T10:51:27Z","reference_number":"EMA/534088/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0396-2024-ema-decision-6-december-2024-agreement-paediatric-investigation-plan-granting-deferral-gorilla-adenovirus-vector-expressing-hpv6-hpv11-antigens-prgn-2012-emea-003592-pip01-24_en.pdf"},
    {"id":"71570","name":"P/0402/2024: EMA decision of 18 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for diazoxide choline, (EMEA-003614-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T10:52:17Z","last_updated_date":"2025-12-09T10:52:17Z","reference_number":"EMA/591389/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0402-2024-ema-decision-18-december-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-diazoxide-choline-emea-003614-pip01-24_en.pdf"},
    {"id":"71000","name":"Agenda - 15th Industry stakeholder platform on research and development support","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-11-04T17:18:07Z","last_updated_date":"2025-12-09T11:11:11Z","reference_number":"EMA/293578/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-15th-industry-stakeholder-platform-research-development-support_en.pdf"},
    {"id":"71602","name":"Presentation - Focus Group on agility in scientific advice (I.Gravanis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:13:35Z","last_updated_date":"2025-12-09T11:13:35Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-focus-group-agility-scientific-advice-igravanis-ema_en.pdf"},
    {"id":"71604","name":"Presentation - Streamlining product-specific bioequivalence guidance (C.Versantvoort, D.van den Haak, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:15:07Z","last_updated_date":"2025-12-09T11:15:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-streamlining-product-specific-bioequivalence-guidance-cversantvoort-dvan-den-haak-ema_en.pdf"},
    {"id":"71606","name":"Presentation - Mechanism of action based PIPs in paediatric oncology (M.Sheean, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:19:17Z","last_updated_date":"2025-12-09T11:19:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-mechanism-action-based-pips-paediatric-oncology-msheean-ema_en.pdf"},
    {"id":"71607","name":"Presentation - Implementation of pilot initiatives based on first 5 years’ experience of PRIME: Analysis (K.Cunningham, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:19:51Z","last_updated_date":"2025-12-09T11:19:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-implementation-pilot-initiatives-based-first-5-years-experience-prime-analysis-kcunningham-ema_en.pdf"},
    {"id":"71608","name":"Presentation - Updates from EMA on scientific advice (I.Gravanis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:20:32Z","last_updated_date":"2025-12-09T11:20:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-updates-ema-scientific-advice-igravanis-ema_en.pdf"},
    {"id":"71609","name":"Presentation - Reframing the voluntary data submission to foster regulatory acceptance of NAMs (S.Ponzano, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:21:05Z","last_updated_date":"2025-12-09T11:21:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-reframing-voluntary-data-submission-foster-regulatory-acceptance-nams-sponzano-ema_en.pdf"},
    {"id":"60449","name":"Draft guideline on the development and manufacture of synthetic peptides","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2023-10-18 - 2024-04-30","first_published_date":"2023-10-18T17:08:00Z","last_updated_date":"2023-10-18T17:08:00Z","reference_number":"EMA/CHMP/CVMP/QWP/387541/2023","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-development-manufacture-synthetic-peptides_en.pdf"},
    {"id":"65870","name":"Alzheimer’s disease EU-IN Horizon Scanning Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2024-11-28T15:10:00Z","last_updated_date":"2025-12-09T11:41:36Z","reference_number":"EMA/540805/2024 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/alzheimers-disease-eu-horizon-scanning-report_en.pdf"},
    {"id":"66931","name":"New Approach Methodologies EU-IN Horizon Scanning Report","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-02-24T15:21:27Z","last_updated_date":"2025-12-09T11:43:50Z","reference_number":"EMA/56850/2025 Rev.1","document_url":"https://www.ema.europa.eu/en/documents/report/new-approach-methodologies-eu-horizon-scanning-report_en.pdf"},
    {"id":"66588","name":"3-year work plan for the joint CHMP/CVMP Quality Working Party 2026-2028","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T12:13:30Z","last_updated_date":"2025-12-09T12:13:30Z","reference_number":"EMA/160693/2025","document_url":"https://www.ema.europa.eu/en/documents/other/3-year-work-plan-joint-chmp-cvmp-quality-working-party-2026-2028_en.pdf"},
    {"id":"66581","name":"3-year work plan for the Biologics Working Party (BWP) 2026-2028","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:36:16Z","last_updated_date":"2025-12-09T11:36:16Z","reference_number":"EMADOC-628903358-21653","document_url":"https://www.ema.europa.eu/en/documents/other/3-year-work-plan-biologics-working-party-bwp-2026-2028_en.pdf"},
    {"id":"66582","name":"3-year rolling work plan for the Biosimilar Medicinal Products Working Party 2026-2028","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:41:41Z","last_updated_date":"2025-12-09T11:41:41Z","reference_number":"EMA/CHMP/BMWP/156161/2025","document_url":"https://www.ema.europa.eu/en/documents/other/3-year-rolling-work-plan-biosimilar-medicinal-products-working-party-2026-2028_en.pdf"},
    {"id":"71584","name":"European sales and use of antimicrobials for veterinary medicine: Annual surveillance report for 2024","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T12:57:00Z","last_updated_date":"2025-12-09T12:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/european-sales-use-antimicrobials-veterinary-medicine-annual-surveillance-report-2024_en.pdf"},
    {"id":"71603","name":"Presentation - HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic modelsfor regulatory assessment - Summary report from the meeting and follow-up activities (E.Manolis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:14:26Z","last_updated_date":"2025-12-09T11:14:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hma-ema-multi-stakeholder-workshop-reporting-qualification-mechanistic-modelsfor-regulatory-assessment-summary-report-meeting-follow-activities-emanolis-ema_en.pdf"},
    {"id":"71605","name":"Presentation - Future-proofing Qualification of Novel Methodologies (QoNM) - Update on delivery of the action plan  (I.Gravanis, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T11:16:02Z","last_updated_date":"2025-12-09T11:16:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-future-proofing-qualification-novel-methodologies-qonm-update-delivery-action-plan-igravanis-ema_en.pdf"},
    {"id":"71623","name":"Combination Products Operational Group (COMBO) - Terms of reference","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T15:01:06Z","last_updated_date":"2025-12-09T15:01:06Z","reference_number":"EMA/219064/2025","document_url":"https://www.ema.europa.eu/en/documents/other/combination-products-operational-group-combo-terms-reference_en.pdf"},
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    {"id":"51296","name":"Meeting Summary - PCWP HCPWP joint meeting March 2021","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2021-05-31T09:44:00Z","last_updated_date":"2021-05-31T09:44:00Z","reference_number":"EMA/158664/2021","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-pcwp-hcpwp-joint-meeting-march-2021_en.pdf"},
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    {"id":"46351","name":"Meeting summary - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2019-12-19T16:34:00Z","last_updated_date":"2019-12-19T16:34:00Z","reference_number":"EMA/527554/2019","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-annual-patients-consumers-working-party-pcwp-healthcare-professionals-working-party-hcpwp-meeting-all-eligible-organisations_en.pdf"},
    {"id":"45878","name":"Meeting summary - European Medicines Agency (EMA) Patients' and Consumers' Working Party meeting (PCWP)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2019-11-04T09:22:00Z","last_updated_date":"2019-11-04T09:22:00Z","reference_number":"EMA/546723/2019","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-european-medicines-agency-ema-patients-consumers-working-party-meeting-pcwp_en.pdf"},
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    {"id":"42651","name":"Meeting summary - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP)","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-11-12T14:47:00Z","last_updated_date":"2018-11-12T14:47:00Z","reference_number":"EMA/717595/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-european-medicines-agency-ema-human-scientific-committees-working-parties-patients-consumers-organisations-pcwp_en.pdf"},
    {"id":"31571","name":"Meeting summary - Tripartite meeting held between the PMDA, EMA, and FDA in Kyoto, Japan to discuss convergence on approaches for the evaluation of antibacterial drugs","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-11-17T13:00:00Z","last_updated_date":"2017-11-17T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-tripartite-meeting-held-between-pmda-ema-fda-kyoto-japan-discuss-convergence-approaches-evaluation-antibacterial-drugs_en.pdf"},
    {"id":"38992","name":"Meeting summary - Second tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-06-12T12:30:00Z","last_updated_date":"2017-06-12T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-second-tripartite-meeting-held-between-ema-pmda-fda-discuss-regulatory-approaches-evaluation-antibacterial-agents_en.pdf"},
    {"id":"9087","name":"Meeting summary - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2018-06-27T17:30:00Z","last_updated_date":"2018-06-27T17:30:00Z","reference_number":"EMA/259214/2018","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-european-medicines-agency-ema-human-scientific-committees-working-parties-patients-consumers-organisations-pcwp-healthcare-professionals-organisations-hcpwp-joint-meeting_en.pdf"},
    {"id":"33748","name":"Meeting summary - Patients and Consumers Working Party (PCWP) meeting with all EMA eligible patient/consumer organisations","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2017-12-11T16:26:00Z","last_updated_date":"2017-12-11T16:26:00Z","reference_number":"EMA/757232/2017","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-patients-consumers-working-party-pcwp-meeting-all-ema-eligible-patient-consumer-organisations_en.pdf"},
    {"id":"71627","name":"Meeting summary - PCWP/HCPWP and all eligible organisations meeting 18 November 2025","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T15:50:10Z","last_updated_date":"2025-12-09T15:50:10Z","reference_number":"EMA/364256/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/meeting-summary-pcwp-hcpwp-all-eligible-organisations-meeting-18-november-2025_en.pdf"},
    {"id":"71631","name":"Mandate, objectives and rules of procedure for the Cancer Medicines Forum","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T16:15:59Z","last_updated_date":"2025-12-09T16:15:59Z","reference_number":"EMA/CHMP/58471/2024","document_url":"https://www.ema.europa.eu/en/documents/other/mandate-objectives-rules-procedure-cancer-medicines-forum_en.pdf"},
    {"id":"4263","name":"List of substances and products subject to worksharing for signal management","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2012-10-05T02:00:00Z","last_updated_date":"2025-12-09T15:22:00Z","reference_number":"EMA/563056/2014 Rev. 14","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/list-substances-products-subject-worksharing-signal-management_en.xlsx"},
    {"id":"71624","name":"Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T15:07:33Z","last_updated_date":"2025-12-09T15:07:33Z","reference_number":"EMA/CHMP/187129/2016","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use_en.pdf"},
    {"id":"71625","name":"Overview of comments received on 'Information for the package leaflet regarding dextrans used as excipients in medicinal products for human use' (EMA/CHMP/187129/2016)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2025-12-09T15:09:42Z","last_updated_date":"2025-12-09T15:09:42Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-information-package-leaflet-regarding-dextrans-used-excipients-medicinal-products-human-use-ema-chmp-187129-2016_en.pdf"},
    {"id":"60019","name":"Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2023-09-15T14:00:00Z","last_updated_date":"2024-10-18T15:00:00Z","reference_number":"EMA/CVMP/SWP/32027/2022","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-safety-residue-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-not-eligible-authorisation-under-article-23-regulation-eu-2019-6_en.pdf"},
    {"id":"65350","name":"Overview of comments received on guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019/6","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2024-10-18T15:10:00Z","last_updated_date":"2024-10-18T15:10:00Z","reference_number":"EMA/CVMP/SWP/46749/2024","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-guideline-safety-residue-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-not-eligible-authorisation-under-art-23-reg_en.pdf"},
    {"id":"71647","name":"Minutes of the CAT meeting 8-9 October 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-12-10T14:47:06Z","last_updated_date":"2025-12-10T14:47:06Z","reference_number":"EMA/CAT/383728/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-8-9-october-2025_en.pdf"},
    {"id":"71648","name":"Withdrawal assessment report for Sirolimus TriviumVet","type":"withdrawal-report","status":"Adopted","consultation_date":"","first_published_date":"2025-12-10T14:51:53Z","last_updated_date":"2025-12-10T14:51:53Z","reference_number":"EMA/108424/2025","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-sirolimus-triviumvet_en.pdf"},
    {"id":"71649","name":"Withdrawal letter : Sirolimus TriviumVet","type":"withdrawal-letter","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T14:53:55Z","last_updated_date":"2025-12-10T14:53:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-sirolimus-triviumvet_en.pdf"},
    {"id":"4306","name":"EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)","type":"regulatory-procedural-guideline","status":"unknown","consultation_date":"","first_published_date":"2009-04-01T02:00:00Z","last_updated_date":"2025-12-10T15:00:00Z","reference_number":"EMA/534107/2008 Rev.5","document_url":"https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-procedural-advice-medicinal-products-intended-exclusively-markets-outside-european-union-context-co-operation-world-health-organisation-who_en.pdf"},
    {"id":"71652","name":"Presentation - Enpr-EMA Annual Report 2024-2025 (P. Lepola, I. Sanchez)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:10:11Z","last_updated_date":"2025-12-10T15:10:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-annual-report-2024-2025-p-lepola-i-sanchez_en.pdf"},
    {"id":"71653","name":"Presentation - Case study: Leveraging external data for efficient pediatric study design in multiple sclerosis (D. Hearing, M. Thomas)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:10:47Z","last_updated_date":"2025-12-10T15:10:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-leveraging-external-data-efficient-pediatric-study-design-multiple-sclerosis-d-hearing-m-thomas_en.pdf"},
    {"id":"71655","name":"Presentation - Case Study: Novel Pediatric Trial Design - A study to evaluate the efficacy, safety, and tolerability of Brivaracetam (G. Calarco Smith)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:11:27Z","last_updated_date":"2025-12-10T15:11:27Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-case-study-novel-pediatric-trial-design-study-evaluate-efficacy-safety-tolerability-brivaracetam-g-calarco-smith_en.pdf"},
    {"id":"71656","name":"Presentation - Translation research from lab to patients - Latest innovations by EPTRI (D. Bonifazi)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:12:36Z","last_updated_date":"2025-12-10T15:12:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-translation-research-lab-patients-latest-innovations-eptri-d-bonifazi_en.pdf"},
    {"id":"71657","name":"Presentation - Restoring agility - AI and the future of the paediatric research in Europe (J. Isla)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:13:12Z","last_updated_date":"2025-12-10T15:13:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-restoring-agility-ai-future-paediatric-research-europe-j-isla_en.pdf"},
    {"id":"71658","name":"Presentation - European Health Data Space (D. Morales)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:13:51Z","last_updated_date":"2025-12-10T15:13:51Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-european-health-data-space-d-morales_en.pdf"},
    {"id":"71661","name":"Presentation - Overview of ICH E6 R3 renovation (P.Twomey)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:15:30Z","last_updated_date":"2025-12-10T15:15:30Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-overview-ich-e6-r3-renovation-ptwomey_en.pdf"},
    {"id":"71662","name":"Agenda - 2025 annual internal meeting of the European network of paediatric research at the EMA (Enpr-EMA)","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:00:16Z","last_updated_date":"2025-12-10T15:00:16Z","reference_number":"EMA/156669/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-2025-annual-internal-meeting-european-network-paediatric-research-ema-enpr-ema_en.pdf"},
    {"id":"71663","name":"Presentation - Quality criteria for paediatric clinical trial sites - an Enpr-EMA initiative (R. Fernandez, P. Skovby)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:01:39Z","last_updated_date":"2025-12-10T15:01:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-quality-criteria-paediatric-clinical-trial-sites-enpr-ema-initiative-r-fernandez-p-skovby_en.pdf"},
    {"id":"71664","name":"Presentation - Paediatric cross-border clinical trials: Enpr-EMA Working Group (B. Nafria)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:02:46Z","last_updated_date":"2025-12-10T15:02:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-paediatric-cross-border-clinical-trials-enpr-ema-working-group-b-nafria_en.pdf"},
    {"id":"71665","name":"Presentation - Enpr-EMA Paediatric research nurse working group (P. Dicks)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:04:23Z","last_updated_date":"2025-12-10T15:04:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-enpr-ema-paediatric-research-nurse-working-group-p-dicks_en.pdf"},
    {"id":"71666","name":"Presentation - Patient and public involvement (PPI) working group (S. Gaillard)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:05:43Z","last_updated_date":"2025-12-10T15:05:43Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-public-involvement-ppi-working-group-s-gaillard_en.pdf"},
    {"id":"71667","name":"Presentation - ACT EU: Collaboration with Enpr-EMA (L. Pioppo, M. Al)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:06:45Z","last_updated_date":"2025-12-10T15:06:45Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-act-eu-collaboration-enpr-ema-l-pioppo-m-al_en.pdf"},
    {"id":"71668","name":"Presentation - The Lancet Child & Adolescent Health Commission on the future of neonatology (M. Turner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-10T15:08:20Z","last_updated_date":"2025-12-10T15:08:20Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-lancet-child-adolescent-health-commission-future-neonatology-m-turner_en.pdf"},
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    {"id":"71028","name":"From laboratory to patients: How the safety of medicines is ensured in the European Union","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-11-06T12:00:00Z","last_updated_date":"2025-12-11T12:28:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/laboratory-patients-how-safety-medicines-ensured-european-union_en.pdf"},
    {"id":"62352","name":"Methodology European Specialised Expert Community (ESEC): Members","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T10:20:00Z","last_updated_date":"2025-12-11T12:25:00Z","reference_number":"EMA/389254/2025","document_url":"https://www.ema.europa.eu/en/documents/other/methodology-european-specialised-expert-community-esec-members_en.pdf"},
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    {"id":"71688","name":"CHMP post-authorisation summary of positive opinion for Simponi (II-121)","type":"smop","status":"Adopted","consultation_date":"","first_published_date":"2025-12-12T13:49:58Z","last_updated_date":"2025-12-12T13:49:58Z","reference_number":"EMA/CHMP/378614/2025","document_url":"https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-simponi-ii-121_en.pdf"},
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    {"id":"59896","name":"Checklist for the submission of day +5 translations for a post-opinion linguistic review - veterinary","type":"template-form","status":"unknown","consultation_date":"","first_published_date":"2023-09-05T11:20:00Z","last_updated_date":"2025-12-12T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/template-form/checklist-submission-day-5-translations-post-opinion-linguistic-review-veterinary_en.docx"},
    {"id":"71734","name":"Presentation - Actions arising from previous meeting and other updates (M. Filancia, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-12T14:35:22Z","last_updated_date":"2025-12-12T14:35:22Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-actions-arising-previous-meeting-other-updates-m-filancia-ema_en.pdf-1"},
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    {"id":"71739","name":"Presentation - OPEN framework (N. Perombelon, H. Cuenca & R. Cherif, EMA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-12T14:46:04Z","last_updated_date":"2025-12-12T14:46:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-open-framework-n-perombelon-h-cuenca-r-cherif-ema_en.pdf"},
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    {"id":"71743","name":"Biomarkers in oncology indications approved in the EU: key facts","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-12T16:30:00Z","last_updated_date":"2025-12-12T16:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/biomarkers-oncology-indications-approved-eu-key-facts_en.pdf"},
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    {"id":"71747","name":"Minutes of the CVMP meeting 4-6 November 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2025-12-12T16:53:48Z","last_updated_date":"2025-12-12T16:53:48Z","reference_number":"EMA/380332/2025","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-cvmp-meeting-4-6-november-2025_en.pdf"},
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    {"id":"55558","name":"Technology Capability Investment Plan to 2028 - Becoming a digital hub for the European medicines regulator network","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-12-19T10:45:00Z","last_updated_date":"2025-12-19T10:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/technology-capability-investment-plan-2028-becoming-digital-hub-european-medicines-regulator-network_en.pdf"},
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    {"id":"71892","name":"Summary - Joint HMA/EMA multi-stakeholder workshop on Patient Registries for Alzheimer's disease December 2025","type":"report","status":"unknown","consultation_date":"","first_published_date":"2025-12-22T09:38:32Z","last_updated_date":"2025-12-22T09:38:32Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/summary-joint-hma-ema-multi-stakeholder-workshop-patient-registries-alzheimers-disease-december-2025_en.pdf"},
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    {"id":"71902","name":"Presentation - Patient representative perspective: Understanding European perspectives on data sharing (L. Duffner)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2025-12-22T10:01:07Z","last_updated_date":"2025-12-22T10:01:07Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-patient-representative-perspective-understanding-european-perspectives-data-sharing-l-duffner_en.pdf"},
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    {"id":"14255","name":"Revised guideline on requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products - Obsolete","type":"scientific-guideline","status":"Adopted","consultation_date":"","first_published_date":"2005-11-09T01:00:00Z","last_updated_date":"2005-11-09T01:00:00Z","reference_number":"EMEA/CVMP/743/00-Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/revised-guideline-requirements-controls-applied-bovine-serum-used-production-immunological-veterinary-medicinal-products-obsolete_en.pdf"},
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    {"id":"72101","name":"PRAC statistics: January 2026","type":"other","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:53:08Z","last_updated_date":"2026-01-16T10:53:08Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/prac-statistics-january-2026_en.pdf"},
    {"id":"72104","name":"Oxbryta Article-20 procedure - EMA confirms suspension of sickle cell disease medicine Oxbryta","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-10-17T12:16:52Z","last_updated_date":"2025-10-17T12:16:52Z","reference_number":"EMA/298985/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/oxbryta-article-20-procedure-ema-confirms-suspension-sickle-cell-disease-medicine-oxbryta_en.pdf-0"},
    {"id":"72109","name":"CVMP summary of positive opinion for Lotilaner / Milbemycin Elanco","type":"smop-initial","status":"Adopted","consultation_date":"","first_published_date":"2026-01-16T13:33:50Z","last_updated_date":"2026-01-16T13:33:50Z","reference_number":"EMA/CVMP/1734/2026","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-lotilaner-milbemycin-elanco_en.pdf"},
    {"id":"67490","name":"Guidance for rapporteurs and members of drafting groups of documents developed by the GMP/GDP Inspectors Working Group","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-03-27T13:16:56Z","last_updated_date":"2026-01-16T15:07:00Z","reference_number":"EMA/INS/GMP/79525/2025","document_url":"https://www.ema.europa.eu/en/documents/other/guidance-rapporteurs-members-drafting-groups-documents-developed-gmp-gdp-inspectors-working-group_en.pdf"},
    {"id":"72115","name":"Direct healthcare professional communication (DHPC) : Mysimba (naltrexone/bupropion): long-term cardiovascular risk and new recommendations on annual assessment ","type":"dhpc","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T15:58:53Z","last_updated_date":"2026-01-16T15:58:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-mysimba-naltrexone-bupropion-long-term-cardiovascular-risk-new-recommendations-annual-assessment_en.pdf"},
    {"id":"72076","name":"Agenda of the HMPC meeting 19-21 January 2026","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2026-01-19T08:31:16Z","last_updated_date":"2026-01-19T08:31:16Z","reference_number":"EMA/HMPC/388321/2025","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-hmpc-meeting-19-21-january-2026_en.pdf"},
    {"id":"72120","name":"eCTD v4.0 implementation milestones - Industry","type":"other","status":"unknown","consultation_date":"","first_published_date":"2026-01-19T10:37:46Z","last_updated_date":"2026-01-19T10:37:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/other/ectd-v40-implementation-milestones-industry_en.pdf"},
    {"id":"66071","name":"Union list of critical medicines - version 2.1 (revision 1)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2025-12-12T11:05:00Z","last_updated_date":"2026-01-19T12:48:00Z","reference_number":"EMA/361872/2025","document_url":"https://www.ema.europa.eu/en/documents/other/union-list-critical-medicines-en.xlsx"},
    {"id":"72130","name":"Methodology for the annual review of the Union list of critical medicines","type":"other","status":"unknown","consultation_date":"","first_published_date":"2026-01-19T12:47:04Z","last_updated_date":"2026-01-19T12:47:04Z","reference_number":"EMA/376463/2025","document_url":"https://www.ema.europa.eu/en/documents/other/methodology-annual-review-union-list-critical-medicines_en.pdf"},
    {"id":"72058","name":"Fibroblast growth factor 21 analogue (NNC194-0499; zalfermin) / semaglutide : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T13:03:12Z","last_updated_date":"2026-01-15T13:03:12Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/fibroblast-growth-factor-21-analogue-nnc194-0499-zalfermin-semaglutide-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"72012","name":"Antisense oligonucleotide against patatin like phospholipase domain containing protein 3 gene (PNPLA3), conjugated to....sodium salt : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2026-01-12T14:15:16Z","last_updated_date":"2026-01-12T14:15:16Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/antisense-oligonucleotide-against-patatin-phospholipase-domain-containing-protein-3-gene-pnpla3-conjugated-tosodium-salt-notification-discontinuation-paediatric-development-which-covered-agreed-pip_en.pdf"},
    {"id":"72011","name":"Grass pollen allergen extract from Dactylis glomerata L., Anthoxanthum odoratum L., Lolium perenne L., Poa prantensis L. and Phleum pratense L. : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2026-01-12T14:07:33Z","last_updated_date":"2026-01-12T14:07:33Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/grass-pollen-allergen-extract-dactylis-glomerata-l-anthoxanthum-odoratum-l-lolium-perenne-l-poa-prantensis-l-phleum-pratense-l-notification-discontinuation-paediatric-development-which-covered-agreed_en.pdf"},
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    {"id":"70880","name":"Outer membrane vesicles (OMV) from N. meningitidis Strain NZ 98/254.... : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-10-28T13:39:38Z","last_updated_date":"2025-10-28T13:39:38Z","reference_number":"EMEA-001260-PIP01-11-M03","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/outer-membrane-vesicles-omv-n-meningitidis-strain-nz-98-254-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
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    {"id":"70510","name":"Cendakimab : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-10-09T14:14:17Z","last_updated_date":"2025-10-09T14:14:17Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/cendakimab-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
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    {"id":"70489","name":"Human alpha-1 proteinase inhibitor, modified (SerpinPC) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-10-08T10:43:39Z","last_updated_date":"2025-10-08T10:43:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/human-alpha-1-proteinase-inhibitor-modified-serpinpc-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"70476","name":"Varicella-zoster virus (inactivated) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-10-07T16:01:29Z","last_updated_date":"2025-10-07T16:01:29Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/varicella-zoster-virus-inactivated-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"70472","name":"Obinutuzumab : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-10-07T15:23:47Z","last_updated_date":"2025-10-07T15:23:47Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/obinutuzumab-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"68753","name":"Bemnifosbuvir : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-06-13T15:33:58Z","last_updated_date":"2025-06-13T15:33:58Z","reference_number":"EMEA-002963-PIP01-21-M01","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/bemnifosbuvir-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"44609","name":"Carotuximab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2019-05-29T10:42:00Z","last_updated_date":"2019-05-29T10:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/carotuximab-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"8071","name":"Pollen from Dactylis glomarata, Festuca pratensis, Lolium perenne, Phleum\n\npratense, Secale cereale (20% each) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-invest...","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pollen-dactylis-glomarata-festuca-pratensis-lolium-perenne-phleum-pratense-secale-cereale-20-each-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-invest_en.pdf"},
    {"id":"13253","name":"Telcagepant - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2014-07-31T18:45:00Z","last_updated_date":"2014-07-31T18:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/telcagepant-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"16754","name":"Faldaprevir - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2014-11-05T15:15:00Z","last_updated_date":"2014-11-05T15:15:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/faldaprevir-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"19614","name":"Eritoran - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-05-30T17:20:00Z","last_updated_date":"2017-05-30T17:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/eritoran-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"20021","name":"Soliris - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-04-18T17:25:00Z","last_updated_date":"2017-04-18T17:25:00Z","reference_number":"EMEA-000876-PIP07-15","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/soliris-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
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    {"id":"41704","name":"Diallertest - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-04-18T17:35:00Z","last_updated_date":"2017-04-18T17:35:00Z","reference_number":"EMEA-000201-PIP01-08-M01","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/diallertest-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"15356","name":"Cadazolid - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2018-06-08T12:45:00Z","last_updated_date":"2018-06-08T12:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/cadazolid-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"19067","name":"Cebranopadol - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-03-09T13:00:00Z","last_updated_date":"2016-03-09T13:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/cebranopadol-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"24945","name":"Allergen extracts of Dermatophagoides farinae and Dermatophagoides pteronyssinus (each 50%) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decisi...","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/allergen-extracts-dermatophagoides-farinae-dermatophagoides-pteronyssinus-each-50-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decisi_en.pdf"},
    {"id":"25123","name":"Recothrom - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2018-07-06T12:40:00Z","last_updated_date":"2018-07-06T12:40:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/recothrom-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
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    {"id":"30178","name":"Monoclonal IgG1 anti-influenza A antibody - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2018-03-06T13:45:00Z","last_updated_date":"2018-03-06T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/monoclonal-igg1-anti-influenza-antibody-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
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    {"id":"35060","name":"Elacytarabine - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-07-22T14:25:00Z","last_updated_date":"2013-07-22T14:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/elacytarabine-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"40776","name":"Eculizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2018-04-20T13:45:00Z","last_updated_date":"2018-04-20T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/eculizumab-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf-0"},
    {"id":"41379","name":"Flublok - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2018-04-20T13:45:00Z","last_updated_date":"2018-04-20T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/flublok-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"2616","name":"Pollen from Phleum pratense - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pollen-phleum-pratense-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"4333","name":"17 beta-estradiol / etonogestrel - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-07-18T16:17:00Z","last_updated_date":"2016-07-18T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/17-beta-estradiol-etonogestrel-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"16548","name":"Pollen from Alnus glutinosa (33%), Betula verrucosa (33%) and Corylus avellana (33%) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-01-11T01:00:00Z","last_updated_date":"2016-01-11T01:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pollen-alnus-glutinosa-33-betula-verrucosa-33-corylus-avellana-33-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"16869","name":"Solithromycin (anthrax) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2018-04-20T13:45:00Z","last_updated_date":"2018-04-20T13:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/solithromycin-anthrax-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"18049","name":"AllerSlit forte Birch - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2015-02-16T14:20:00Z","last_updated_date":"2015-02-16T14:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/allerslit-forte-birch-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"21035","name":"Abrilumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-05-25T13:45:00Z","last_updated_date":"2016-05-25T13:45:00Z","reference_number":"EMEA-001200-PIP01-11","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/abrilumab-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"23420","name":"(1R, 4S, 5S, 6S)-4-[[(2s)-2-amino-4-(methylthio)-1-oxobutyl]amino]-2-thiabicyclo[3.1.0]hexane-4,6-dicarboxylic acid,2,2-dioxide, monohydrate (LY2140023) - Notification of discontinuation of a paediatric development which...","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2015-02-16T17:45:00Z","last_updated_date":"2015-02-16T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/1r-4s-5s-6s-4-2s-2-amino-4-methylthio-1-oxobutylamino-2-thiabicyclo310hexane-46-dicarboxylic-acid22-dioxide-monohydrate-ly2140023-notification-discontinuation-paediatric-development-which_en.pdf"},
    {"id":"26418","name":"Serelaxin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-09-29T19:20:00Z","last_updated_date":"2017-09-29T19:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/serelaxin-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"34060","name":"Translarna - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-03-23T15:54:00Z","last_updated_date":"2017-03-23T15:54:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/translarna-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"34119","name":"Evofosfamide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-01-04T17:30:00Z","last_updated_date":"2017-01-04T17:30:00Z","reference_number":"EMEA-001483-PIP01-13","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/evofosfamide-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"3766","name":"Cediranib maleate - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-06-06T12:00:00Z","last_updated_date":"2013-06-06T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/cediranib-maleate-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"5443","name":"Human Normal Immunoglobulin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-02-17T10:30:00Z","last_updated_date":"2017-02-17T10:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/human-normal-immunoglobulin-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"14977","name":"Recombinant Bet v1 folding variant - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T17:00:00Z","last_updated_date":"2013-10-07T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/recombinant-bet-v1-folding-variant-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"32460","name":"Bisoctrizole, titanium dioxide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T17:00:00Z","last_updated_date":"2013-10-07T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/bisoctrizole-titanium-dioxide-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"36658","name":"6,7-dihydro-5H-pyrrolo[1,2-c] imidazol-5-yl) - (benzo derivative) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-11-21T13:01:00Z","last_updated_date":"2017-11-21T13:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/67-dihydro-5h-pyrrolo12-c-imidazol-5-yl-benzo-derivative-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"39093","name":"Ferumoxytol - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2015-05-06T12:30:00Z","last_updated_date":"2015-05-06T12:30:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/ferumoxytol-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"41651","name":"Influenza virus surface antigens inactivated, of H1N1, H3N2 and B strains recommended by World Health Organization (Optaflu) - Notification of discontinuation of a paediatric development which is covered by an agreed pae...","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T17:00:00Z","last_updated_date":"2013-10-07T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/influenza-virus-surface-antigens-inactivated-h1n1-h3n2-b-strains-recommended-world-health-organization-optaflu-notification-discontinuation-paediatric-development-which-covered-agreed-pae_en.pdf"},
    {"id":"43991","name":"Rolofylline - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2019-03-08T09:58:00Z","last_updated_date":"2019-03-08T09:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/rolofylline-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"44909","name":"5-( 4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[ 4,5- H][2,3]benzodiazepin-2-one (S44819) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2019-06-27T14:06:00Z","last_updated_date":"2019-06-27T14:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/5-4-fluoro-1-benzothiophen-2-yl-8-methyl-19-dihydro-2h-13oxazolo-45-h23benzodiazepin-2-one-s44819-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan_en.pdf"},
    {"id":"45208","name":"Depatuxizumab mafodotin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2019-08-07T15:21:00Z","last_updated_date":"2019-08-07T15:21:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/depatuxizumab-mafodotin-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"7917","name":"Bitopertin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2014-11-19T12:00:00Z","last_updated_date":"2014-11-19T12:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/bitopertin-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"16142","name":"Cilengitide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T17:00:00Z","last_updated_date":"2013-10-07T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/cilengitide-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"16850","name":"Evacetrapib - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2015-10-22T11:20:00Z","last_updated_date":"2015-10-22T11:20:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/evacetrapib-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"21716","name":"Casopitant - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2015-01-23T15:25:00Z","last_updated_date":"2015-01-23T15:25:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/casopitant-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"26740","name":"Odanacatib - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2016-10-20T02:00:00Z","last_updated_date":"2016-10-20T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/odanacatib-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"27244","name":"Nicotinic acid / laropiprant (Tredaptive) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2013-10-07T17:00:00Z","last_updated_date":"2013-10-07T17:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/nicotinic-acid-laropiprant-tredaptive-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"32737","name":"Eculizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2015-07-27T02:00:00Z","last_updated_date":"2015-07-27T02:00:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/eculizumab-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"33378","name":"Zontivity - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-11-30T17:51:00Z","last_updated_date":"2017-11-30T17:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/zontivity-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"38050","name":"Katclari - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2017-06-19T16:36:00Z","last_updated_date":"2017-06-19T16:36:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/katclari-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
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    {"id":"50392","name":"Elbasvir - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-03-04T10:23:00Z","last_updated_date":"2022-11-29T16:51:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/elbasvir-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"50613","name":"Peginesatide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-03-17T14:39:00Z","last_updated_date":"2021-03-17T14:39:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/peginesatide-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
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    {"id":"66501","name":"2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis- 2,6-bis-(2,6-diamino-hexanoylamino).......polysodium salt : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2025-01-29T11:29:11Z","last_updated_date":"2025-01-29T11:29:11Z","reference_number":"EMEA-001354-PIP01-12","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/26-bis-1-napthalenyl-36-disulfonic-acid-oxyacetamido-26-bis-26-bis-26-bis-26-diamino-hexanoylaminopolysodium-salt-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
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    {"id":"57129","name":"Pradigastat  - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-22T10:22:00Z","last_updated_date":"2022-12-22T10:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pradigastat-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"56991","name":"Rimiducid : Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision","type":"pip-discontinuation","status":"Adopted","consultation_date":"","first_published_date":"2022-12-13T18:01:00Z","last_updated_date":"2022-12-13T18:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/rimiducid-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56972","name":"Chemically modified house dust mites allergen extract (dermatophagoides pteronyssinus and dermatophagoides farinae) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T12:17:00Z","last_updated_date":"2022-12-13T12:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/chemically-modified-house-dust-mites-allergen-extract-dermatophagoides-pteronyssinus-dermatophagoides-farinae-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56971","name":"Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T12:13:00Z","last_updated_date":"2022-12-13T12:13:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/chemically-modified-extract-grass-pollen-holcus-lanatus-phleum-pratense-poa-pratensis-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56970","name":"Chemically modified extract of trees pollen from birch and alder : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T12:07:00Z","last_updated_date":"2022-12-13T12:07:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/chemically-modified-extract-trees-pollen-birch-alder-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56969","name":"Testosterone : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-13T11:58:00Z","last_updated_date":"2022-12-13T11:58:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/testosterone-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56882","name":"Atazanavir / Ritonavir - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-06T09:37:00Z","last_updated_date":"2022-12-06T09:37:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/atazanavir-ritonavir-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56869","name":"Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-02T15:32:00Z","last_updated_date":"2022-12-02T15:32:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/bivalent-anti-human-myostatin-adnectin-recombinant-human-igg1-fc-fusion-protein-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"56867","name":"(S)-3'-(OH)-desazadesferrithiocin-polyether, magnesium salt (FBS0701) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-12-02T14:06:00Z","last_updated_date":"2022-12-02T14:06:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/s-3-oh-desazadesferrithiocin-polyether-magnesium-salt-fbs0701-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55403","name":"Isavuconazonium (sulfate) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-29T11:57:00Z","last_updated_date":"2022-06-29T11:57:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/isavuconazonium-sulfate-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"55237","name":"Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401) : Notification of discontinuation of a paediatric development which is covered by an agreed  PIP decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-14T13:22:00Z","last_updated_date":"2022-06-14T13:22:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/expanded-human-autologous-mesenchymal-adult-stem-cells-extracted-adipose-tissue-cx-401-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55236","name":"Insulin peglispro : Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-14T13:02:00Z","last_updated_date":"2022-06-14T13:02:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/insulin-peglispro-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55235","name":"Recombinant human heparan-N-sulfatase (rhHNS, SHP610, HGT-1410, Sulfamidase, San-A) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-14T12:49:00Z","last_updated_date":"2022-06-14T12:49:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/recombinant-human-heparan-n-sulfatase-rhhns-shp610-hgt-1410-sulfamidase-san-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55234","name":"Methyl aminolevulinate hydrochloride : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-14T12:38:00Z","last_updated_date":"2022-06-14T12:38:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/methyl-aminolevulinate-hydrochloride-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55183","name":"Arimoclomol citrate : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-10T12:04:00Z","last_updated_date":"2022-06-10T12:04:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/arimoclomol-citrate-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55171","name":"Deleobuvir : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-09T15:03:00Z","last_updated_date":"2022-06-09T15:03:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/deleobuvir-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"55139","name":"Selonsertib : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-06-07T13:29:00Z","last_updated_date":"2022-06-07T13:29:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/selonsertib-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"54735","name":"Tanezumab - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-04-12T14:44:00Z","last_updated_date":"2022-04-12T14:44:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/tanezumab-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"54728","name":"Zorecimeran - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-04-11T17:27:00Z","last_updated_date":"2022-04-11T17:27:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/zorecimeran-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"54590","name":"Pevonedistat - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-03-25T11:42:00Z","last_updated_date":"2022-03-25T11:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pevonedistat-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"54557","name":"Pimodivir - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-03-24T15:48:00Z","last_updated_date":"2022-03-24T15:48:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pimodivir-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"54556","name":"Venglustat - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-03-24T15:45:00Z","last_updated_date":"2022-03-24T15:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/venglustat-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"54533","name":"Clazakizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-03-21T09:42:00Z","last_updated_date":"2022-03-21T09:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/clazakizumab-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"54121","name":"Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-02-09T16:17:00Z","last_updated_date":"2022-02-09T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/autologous-cd34-haematopoietic-stem-cells-transduced-lentiviral-vector-encoding-human-ba-t87q-globin-gene-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric_en.pdf"},
    {"id":"54104","name":"Naloxone hydrochloride - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-02-08T16:17:00Z","last_updated_date":"2022-02-08T16:17:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/naloxone-hydrochloride-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"54058","name":"Bumetanide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2022-02-03T14:19:00Z","last_updated_date":"2022-02-03T14:19:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/bumetanide-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53445","name":"Fluticasone furoate, vilanterol trifenatate and umeclidinium bromide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-12-10T17:45:00Z","last_updated_date":"2021-12-10T17:45:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/fluticasone-furoate-vilanterol-trifenatate-umeclidinium-bromide-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53444","name":"Dipalmitoylphosphatidylcholine / 1-palmitoyl-2-oleoyl-sn-glycero-3- phosphoglycerol sodium salt /synthetic surfactant (...) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-12-10T17:42:00Z","last_updated_date":"2021-12-10T17:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/dipalmitoylphosphatidylcholine-1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol-sodium-salt-synthetic-surfactant-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric_en.pdf"},
    {"id":"53346","name":"Retosiban - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T09:42:00Z","last_updated_date":"2021-12-01T09:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/retosiban-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53345","name":"Human immunoglobulin G2 isotype antibody to IL-33R - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-12-01T09:42:00Z","last_updated_date":"2021-12-01T09:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/human-immunoglobulin-g2-isotype-antibody-il-33r-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53335","name":"Octenidine dihydrochloride - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-11-29T17:50:00Z","last_updated_date":"2021-11-29T17:50:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/octenidine-dihydrochloride-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53336","name":"Susoctocog alfa - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-11-29T09:42:00Z","last_updated_date":"2021-11-29T09:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/susoctocog-alfa-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53334","name":"2-[[2-ethyl-6-[4-[2-(3-hydroxyazetidin-1-yl)-2-oxoethyl]piperazin-1-yl]-8-methylimidazo[1,2-a]pyridin-3-yl](methyl)amino]-4-(4-fluorophenyl)-1,3-thiazole-5-carbonitrile - Discontinuation of a paediatric development which is covered by agreed PIP decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-11-29T17:42:00Z","last_updated_date":"2021-11-29T17:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/2-2-ethyl-6-4-2-3-hydroxyazetidin-1-yl-2-oxoethylpiperazin-1-yl-8-methylimidazo12-apyridin-3-ylmethylamino-4-4-fluorophenyl-13-thiazole-5-carbonitrile-discontinuation-paediatric-development-which_en.pdf"},
    {"id":"53195","name":"Carisbamate - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-11-22T09:42:00Z","last_updated_date":"2021-11-22T09:42:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/carisbamate-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"53168","name":"[(3S)-6-({2',6'-Dimethyl-4'-[3-(methylsulfonyl) propoxy] biphenyl-3-yl}methoxy)-2,3-dihydro-1-benzofuran-3-yl]acetic acid hydrate (TAK-875) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-11-19T16:55:00Z","last_updated_date":"2021-11-19T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/3s-6-26-dimethyl-4-3-methylsulfonyl-propoxy-biphenyl-3-ylmethoxy-23-dihydro-1-benzofuran-3-ylacetic-acid-hydrate-tak-875-notification-discontinuation-paediatric-development-which-covered-agreed-pip_en.pdf"},
    {"id":"52820","name":"Empagliflozin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-10-12T16:55:00Z","last_updated_date":"2021-10-12T16:55:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/empagliflozin-notification-discontinuation-paediatric-development-which-covered-agreed-paediatric-investigation-plan-decision_en.pdf"},
    {"id":"49724","name":"Pollen from Betula pendula - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-01-05T16:20:00Z","last_updated_date":"2021-01-05T16:20:00Z","reference_number":"EMEA-000860-PIPOl-10-MOl","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pollen-betula-pendula-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
    {"id":"49723","name":"Pollen from Dactylis glomarata(16%), Lolium perenne(16%), Phleum pratense(16%), Poa pratensis(16%), Anthoxhantum odoratum(16%), Secale cereale(20%) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-01-05T16:16:00Z","last_updated_date":"2021-01-05T16:16:00Z","reference_number":"EMEA-000857-PIP01-10-M01","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pollen-dactylis-glomarata16-lolium-perenne16-phleum-pratense16-poa-pratensis16-anthoxhantum-odoratum16-secale-cereale20-notification-discontinuation-paediatric-development-which-covered-agreed-pip_en.pdf"},
    {"id":"49721","name":"Pollen from Betula pendula (33%), Corylus avellana (33%) and Alnus glutinosa (33%) - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision","type":"pip-discontinuation","status":"unknown","consultation_date":"","first_published_date":"2021-01-05T16:00:00Z","last_updated_date":"2021-01-05T16:00:00Z","reference_number":"EMEA-000852-PIP01-10-M01","document_url":"https://www.ema.europa.eu/en/documents/pip-discontinuation/pollen-betula-pendula-33-corylus-avellana-33-alnus-glutinosa-33-notification-discontinuation-paediatric-development-which-covered-agreed-pip-decision_en.pdf"},
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    {"id":"71622","name":"EMA/PE/0000183329 : EMA decision of 6 December 2024 on the of a modification of an agreed paediatric investigation plan for interleukin-23 receptor antagonist peptide (JNJ-77242113)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T14:38:09Z","last_updated_date":"2025-12-09T14:38:09Z","reference_number":"EMADOC-1700519818-1793192","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000183329-ema-decision-6-december-2024-modification-agreed-paediatric-investigation-plan-interleukin-23-receptor-antagonist-peptide-jnj-77242113_en.pdf"},
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    {"id":"71618","name":"EMA/PE/0000182808 : EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for zoliflodacin","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T13:10:55Z","last_updated_date":"2025-12-09T13:10:55Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000182808-ema-decision-6-december-2024-acceptance-modification-agreed-paediatric-investigation-plan-zoliflodacin_en.pdf"},
    {"id":"71617","name":"EMA/PE/0000183083 : EMA decision of 6 December 2024 on the granting of a product specific waiver for (S)-(4-amino-1,3-dihydrofuro[3,4-c][1,7]naphthyridin-8-yl)(3-(4-(trifluoromethyl)phenyl)morpholino)methanone","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T12:45:57Z","last_updated_date":"2025-12-09T12:45:57Z","reference_number":"EMADOC-1700519818-1784096","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000183083-ema-decision-6-december-2024-granting-product-specific-waiver-s-4-amino-13-dihydrofuro34-c17naphthyridin-8-yl3-4-trifluoromethylphenylmorpholinomethanone_en.pdf"},
    {"id":"71616","name":"EMA/PE/0000182525 : EMA decision of 6 December 2024 on the granting of a product specific waiver for modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens (V940/mRNA-4157)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T12:28:37Z","last_updated_date":"2025-12-09T12:28:37Z","reference_number":"EMADOC-1700519818-1784306","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000182525-ema-decision-6-december-2024-granting-product-specific-waiver-modified-messenger-ribonucleic-acid-encoding-individual-patient-specific-tumour-neoantigens-v940-mrna-4157_en.pdf"},
    {"id":"71613","name":"EMA/PE/0000182462 : EMA decision of 6 December 2024 on the granting of a product specific waiver for bizalimogene ralaplasmid / mavilimogene ralaplasmid / rocakinogene sifuplasmid","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-12-09T11:54:52Z","last_updated_date":"2025-12-09T11:54:52Z","reference_number":"EMADOC-1700519818-1789264","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000182462-ema-decision-6-december-2024-granting-product-specific-waiver-bizalimogene-ralaplasmid-mavilimogene-ralaplasmid-rocakinogene-sifuplasmid_en.pdf"},
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    {"id":"70594","name":"P/0338/2024 : EMA decision of 13 September 2024 on the granting of a product specific waiver for rememulgene arelactibac (EMEA-003638-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-16T12:49:12Z","last_updated_date":"2025-10-16T12:49:12Z","reference_number":"EMA/414280/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0338-2024-ema-decision-13-september-2024-granting-product-specific-waiver-rememulgene-arelactibac-emea-003638-pip01-24_en.pdf"},
    {"id":"70593","name":"P/0326/2024 : EMA decision of 13 September 2025 on the granting of a product specific waiver for empagliflozin / derivative of 3‐phenyl‐3H,4H,6H,7Hpyrano[ 3,4‐d]imidazol‐4‐one (BI 690517), (EMEA-003632-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-16T12:42:15Z","last_updated_date":"2025-10-16T12:42:15Z","reference_number":"EMA/413681/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0326-2024-ema-decision-13-september-2025-granting-product-specific-waiver-empagliflozin-derivative-3-phenyl-3h4h6h7hpyrano-34-dimidazol-4-one-bi-690517-emea-003632-pip01-24_en.pdf"},
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    {"id":"70591","name":"P/0317/2024 : EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for rilonacept (EMEA-003571-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-16T12:31:05Z","last_updated_date":"2025-10-16T12:31:05Z","reference_number":"EMA/410994/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0317-2024-ema-decision-13-september-2024-agreement-paediatric-investigation-plan-granting-waiver-rilonacept-emea-003571-pip01-23_en.pdf"},
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    {"id":"70589","name":"P/0316/2024 : EMA decision of 13 September 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for recombinant humanized IgG1, kappa light chain.....(EMEA-003510-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-10-16T12:11:54Z","last_updated_date":"2025-10-16T12:11:54Z","reference_number":"EMA/410959/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0316-2024-ema-decision-13-september-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-recombinant-humanized-igg1-kappa-light-chainemea-003510-pip01-23_en.pdf"},
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    {"id":"69211","name":"P/0300/2024: EMA decision of 14 August 2024 on the granting of a product specific waiver for anitocabtagene autoleucel (EMEA-003628-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-07-09T18:27:52Z","last_updated_date":"2025-07-09T18:27:52Z","reference_number":"EMA/364617/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0300-2024-ema-decision-14-august-2024-granting-product-specific-waiver-anitocabtagene-autoleucel-emea-003628-pip01-24_en.pdf"},
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    {"id":"68994","name":"P/0219/2024 : EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for purified antigen fractions of inactivated split virion influenza virus type A, H1N1 (EMEA-003641-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T16:55:53Z","last_updated_date":"2025-06-26T16:55:53Z","reference_number":"EMA/255062/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0219-2024-ema-decision-13-june-2024-agreement-paediatric-investigation-plan-granting-waiver-purified-antigen-fractions-inactivated-split-virion-influenza-virus-type-h1n1-emea-003641-pip01-24_en.pdf"},
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    {"id":"68988","name":"P/0210/2024 : EMA decision of 14 June 2024 on the granting of a product specific waiver for rosuvastatin / ezetimibe (EMEA-003582-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T12:29:22Z","last_updated_date":"2025-06-26T12:29:22Z","reference_number":"EMA/234749/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0210-2024-ema-decision-14-june-2024-granting-product-specific-waiver-rosuvastatin-ezetimibe-emea-003582-pip01-24_en.pdf"},
    {"id":"68987","name":"P/0209/2024 : EMA decision of 14 June 2024 on the granting of a product specific waiver for derivative of 1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one (EMEA-003581-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T12:23:35Z","last_updated_date":"2025-06-26T12:23:35Z","reference_number":"EMA/234752/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0209-2024-ema-decision-14-june-2024-granting-product-specific-waiver-derivative-1567-tetrahydro-4h-pyrrolo32-cpyridin-4-one-emea-003581-pip01-24_en.pdf"},
    {"id":"68985","name":"P/0216/2024 : EMA decision of 13 June 2024 on the granting of a product specific waiver for certepetide (EMEA-003577-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T11:44:56Z","last_updated_date":"2025-06-26T11:44:56Z","reference_number":"EMA/255063/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0216-2024-ema-decision-13-june-2024-granting-product-specific-waiver-certepetide-emea-003577-pip01-24_en.pdf"},
    {"id":"68984","name":"P/0223/2024 : EMA decision of 20 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for mirdametinib (EMEA-003525-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T11:36:07Z","last_updated_date":"2025-06-26T11:36:07Z","reference_number":"EMA/284186/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0223-2024-ema-decision-20-june-2024-agreement-paediatric-investigation-plan-granting-deferral-mirdametinib-emea-003525-pip01-23_en.pdf"},
    {"id":"68983","name":"P/0215/2024 : EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for human alpha-1 proteinase inhibitor, modified (SerpinPC) (EMEA-003463- PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T11:29:59Z","last_updated_date":"2025-06-26T11:29:59Z","reference_number":"EMA/255061/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0215-2024-ema-decision-13-june-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-human-alpha-1-proteinase-inhibitor-modified-serpinpc-emea-003463-pip01-23_en.pdf"},
    {"id":"68982","name":"P/0214/2024 : EMA decision of 13 June 2024 on the agreement of a paediatric investigation plan and on the refusal of a deferral for recombinant adeno-associated virus Olig001 containing human aspartoacylase cDNA (MYR-101), (EMEA-003459- PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-26T11:22:25Z","last_updated_date":"2025-06-26T11:22:25Z","reference_number":"EMA/255060/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0214-2024-ema-decision-13-june-2024-agreement-paediatric-investigation-plan-refusal-deferral-recombinant-adeno-associated-virus-olig001-containing-human-aspartoacylase-cdna-myr-101-emea-003459-pip01_en.pdf"},
    {"id":"68952","name":"P/0208/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for olokizumab (EMEA-001222-PIP01-11-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T18:31:00Z","last_updated_date":"2025-06-24T18:31:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0208-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-olokizumab-emea-001222-pip01-11-m01_en.pdf"},
    {"id":"68951","name":"P/0207/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for linaclotide (Constella) (EMEA-000927-PIP01-10-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T18:23:59Z","last_updated_date":"2025-06-24T18:23:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0207-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-linaclotide-constella-emea-000927-pip01-10-m08_en.pdf"},
    {"id":"68949","name":"P/0205/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for obefazimod (EMEA- 003196-PIP01-22-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T18:09:04Z","last_updated_date":"2025-06-24T18:09:04Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0205-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-obefazimod-emea-003196-pip01-22-m01_en.pdf"},
    {"id":"68948","name":"P/0203/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for quizartinib (Vanflyta) (EMEA-001821-PIP01-15-M08)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T18:02:25Z","last_updated_date":"2025-06-24T18:02:25Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0203-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-quizartinib-vanflyta-emea-001821-pip01-15-m08_en.pdf"},
    {"id":"68947","name":"P/0204/2024: EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for derivative of pyrindin-2-yl)cyclopropanecarboxamide hydrochloride (EMEA-003480-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T17:54:28Z","last_updated_date":"2025-06-24T17:54:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0204-2024-ema-decision-14-june-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-derivative-pyrindin-2-ylcyclopropanecarboxamide-hydrochloride-emea-003480-pip01-23_en.pdf"},
    {"id":"68946","name":"EMA decision of 14 June 2024 on the granting of a product-specific waiver for (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4- (prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18... (EMEA-003586-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T17:46:23Z","last_updated_date":"2025-06-24T17:46:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-decision-14-june-2024-granting-product-specific-waiver-5asa17ara-20-chloro-2-2s5r-25-dimethyl-4-prop-2-enoylpiperazin-1-yl-1417-difluoro-6-propan-2-yl-1112-dihydro-4h-118-emea-003586-pip01-24_en.pdf"},
    {"id":"68945","name":"P/0201/2024: EMA decision of 14 June 2024 on the refusal of a paediatric investigation plan and on the granting of a waiver for autologous T-cells from a melanoma metastasis (TM001) (EMEA-003535-PIP02-24)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-06-24T17:34:52Z","last_updated_date":"2025-06-24T17:34:52Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0201-2024-ema-decision-14-june-2024-refusal-paediatric-investigation-plan-granting-waiver-autologous-t-cells-melanoma-metastasis-tm001-emea-003535-pip02-24_en.pdf"},
    {"id":"68938","name":"P/0198/2024: EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ianalumab (EMEA-002338-PIP05-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:13:09Z","last_updated_date":"2025-06-24T16:13:09Z","reference_number":"P/0198/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0198-2024-ema-decision-14-june-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ianalumab-emea-002338-pip05-23_en.pdf"},
    {"id":"68942","name":"P/0199/2024: EMA decision of 14 June 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the refusal of a waiver for brigimadlin (EMEA-003260-PIP03-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:28:38Z","last_updated_date":"2025-06-24T16:28:38Z","reference_number":"P/0199/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0199-2024-ema-decision-14-june-2024-agreement-paediatric-investigation-plan-granting-deferral-refusal-waiver-brigimadlin-emea-003260-pip03-23_en.pdf"},
    {"id":"68943","name":"P/0200/2024: EMA decision of 14 June 2024 on the granting of a product specific waiver for fenofibrate / rosuvastatin calcium (EMEA-003591- PIP01-24) ","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:50:02Z","last_updated_date":"2025-06-24T16:50:02Z","reference_number":"P/0200/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0200-2024-ema-decision-14-june-2024-granting-product-specific-waiver-fenofibrate-rosuvastatin-calcium-emea-003591-pip01-24_en.pdf"},
    {"id":"68941","name":"P/0213/2024 : EMA decision of 14 June 2024 on the granting of a product specific waiver for gallium (68Ga) boclatixafortide (EMEA-003408-PIP02- 24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:32:07Z","last_updated_date":"2025-06-24T16:32:07Z","reference_number":"EMA/267201/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0213-2024-ema-decision-14-june-2024-granting-product-specific-waiver-gallium-68ga-boclatixafortide-emea-003408-pip02-24_en.pdf"},
    {"id":"68940","name":"P/0212/2024 : EMA decision of 14 June 2024 on the granting of a product specific waiver for lebrikizumab (Ebglyss), (EMEA-002536-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:21:10Z","last_updated_date":"2025-06-24T16:21:10Z","reference_number":"EMA/267179/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0212-2024-ema-decision-14-june-2024-granting-product-specific-waiver-lebrikizumab-ebglyss-emea-002536-pip02-24_en.pdf"},
    {"id":"68934","name":"P/0218/2024 : EMA decision of 13 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for recombinant influenza hemagglutinin-strain A......(Yamagata lineage) (RIV4) (Supemtek)(EMEA-002418-PIP01-18-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T15:55:08Z","last_updated_date":"2025-06-24T15:55:08Z","reference_number":"EMA/255064/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2024-ema-decision-13-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-recombinant-influenza-hemagglutinin-strain-ayamagata-lineage-riv4-supemtekemea-002418-pip01-18-m04_en.pdf"},
    {"id":"68937","name":"P/0224/2024 : EMA decision of 27 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for epcoritamab (Tepkinly), (EMEA-002907-PIP01-20-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:09:35Z","last_updated_date":"2025-06-24T16:09:35Z","reference_number":"EMA/284891/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0224-2024-ema-decision-27-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-epcoritamab-tepkinly-emea-002907-pip01-20-m03_en.pdf"},
    {"id":"68936","name":"P/0222/2024 : EMA decision of 20 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T16:01:39Z","last_updated_date":"2025-06-24T16:01:39Z","reference_number":"EMA/283573/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2024-ema-decision-20-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-iptacopan-emea-002705-pip01-19-m02_en.pdf"},
    {"id":"68935","name":"P/0222/2024 : on the acceptance of a modification of an agreed paediatric investigation plan for iptacopan (EMEA- 002705-PIP01-19-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T15:59:53Z","last_updated_date":"2025-06-24T15:59:53Z","reference_number":"EMA/283573/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0222-2024-acceptance-modification-agreed-paediatric-investigation-plan-iptacopan-emea-002705-pip01-19-m02_en.pdf"},
    {"id":"68932","name":"P/0211/2024 : EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for calcifediol (Rayaldee) (EMEA-002093-PIP02-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T15:49:25Z","last_updated_date":"2025-06-24T15:49:25Z","reference_number":"EMA/267114/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0211-2024-ema-decision-14-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-calcifediol-rayaldee-emea-002093-pip02-17-m02_en.pdf"},
    {"id":"68930","name":"P/0217/2024 : EMA decision of 13 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for inebilizumab (Uplizna) (EMEA-001911-PIP03-23-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T15:45:04Z","last_updated_date":"2025-06-24T15:45:04Z","reference_number":"EMA/181396/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0217-2024-ema-decision-13-june-2024-acceptance-modification-agreed-paediatric-investigation-plan-inebilizumab-uplizna-emea-001911-pip03-23-m01_en.pdf"},
    {"id":"68929","name":"P/0221/2024 : EMA decision of 20 June on the acceptance of a modification of an agreed paediatric investigation plan for brexucabtagene autoleucel (Tecartus) (EMEA-001862-PIP01-15-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-24T15:39:40Z","last_updated_date":"2025-06-24T15:39:40Z","reference_number":"EMA/278646/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0221-2024-ema-decision-20-june-acceptance-modification-agreed-paediatric-investigation-plan-brexucabtagene-autoleucel-tecartus-emea-001862-pip01-15-m04_en.pdf"},
    {"id":"68734","name":"P/0165/2024: EMA decision of 6 May 2024 on the acceptance of a modification of an agreed paediatric investigation plan for live, attenuated, dengue virus ... (EMEA-002999-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-12T15:27:28Z","last_updated_date":"2025-06-12T15:27:28Z","reference_number":"EMA/176734/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0165-2024-ema-decision-6-may-2024-acceptance-modification-agreed-paediatric-investigation-plan-live-attenuated-dengue-virus-emea-002999-pip01-21-m01_en.pdf"},
    {"id":"68881","name":"P/0237/2024: EMA decision of 18 July 2024 on the granting of a product specific waiver for allogeneic skin-derived ABCB5-positive dermal mesenchymal stromal cells (Amesanar), (EMEA-002875-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-23T09:57:34Z","last_updated_date":"2025-06-23T09:57:34Z","reference_number":"EMA/319282/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0237-2024-ema-decision-18-july-2024-granting-product-specific-waiver-allogeneic-skin-derived-abcb5-positive-dermal-mesenchymal-stromal-cells-amesanar-emea-002875-pip02-24_en.pdf"},
    {"id":"68676","name":"P/0129/2024: EMA decision of 11 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mirikizumab (Omvoh) (EMEA-002208-PIP02-24)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-06-10T16:44:11Z","last_updated_date":"2025-06-10T16:44:11Z","reference_number":"EMA/142238/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0129-2024-ema-decision-11-april-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-mirikizumab-omvoh-emea-002208-pip02-24_en.pdf"},
    {"id":"68683","name":"P/0123/2024: EMA decision of 11 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for aficamten (EMEA-002958-PIP01-21-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T17:50:41Z","last_updated_date":"2025-06-10T17:50:41Z","reference_number":"EMA/142976/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0123-2024-ema-decision-11-april-2024-acceptance-modification-agreed-paediatric-investigation-plan-aficamten-emea-002958-pip01-21-m01_en.pdf"},
    {"id":"68682","name":"P/0134/2024: EMA decision of 25 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for selumetinib (Koselugo) (EMEA-001585-PIP01-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T17:41:50Z","last_updated_date":"2025-06-10T17:41:50Z","reference_number":"EMA/167583/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0134-2024-ema-decision-25-april-2024-acceptance-modification-agreed-paediatric-investigation-plan-selumetinib-koselugo-emea-001585-pip01-13-m06_en.pdf"},
    {"id":"68681","name":"P/0130/2024: EMA decision of 11 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for mirikizumab (Omvoh), (EMEA-002208-PIP01-17-M04)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T17:30:28Z","last_updated_date":"2025-06-10T17:30:28Z","reference_number":"EMA/142543/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0130-2024-ema-decision-11-april-2024-acceptance-modification-agreed-paediatric-investigation-plan-mirikizumab-omvoh-emea-002208-pip01-17-m04_en.pdf"},
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    {"id":"68679","name":"P/0133/2024: EMA decision of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for enlicitide (decanoate) (EMEA-003453-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T17:12:20Z","last_updated_date":"2025-06-10T17:12:20Z","reference_number":"EMA/144124/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0133-2024-ema-decision-12-april-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-enlicitide-decanoate-emea-003453-pip01-23_en.pdf"},
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    {"id":"68675","name":"P/0128/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for autologous T-cells expressing a chimeric antigenic receptor against G protein coupled receptor class C, group 5, member D (GPRC5D)... (EMEA-003543-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T16:30:15Z","last_updated_date":"2025-06-10T16:30:15Z","reference_number":"EMA/114622/2024 ","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0128-2024-ema-decision-12-april-2024-granting-product-specific-waiver-autologous-t-cells-expressing-chimeric-antigenic-receptor-against-g-protein-coupled-receptor-class-c-group-5-member-d-gprc5d_en.pdf"},
    {"id":"68674","name":"P/0127/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for propylene glycol / urea (EMEA-003542-PIP01-23)","type":"pip-decision","status":"unknown","consultation_date":"","first_published_date":"2025-06-10T16:24:02Z","last_updated_date":"2025-06-10T16:24:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0127-2024-ema-decision-12-april-2024-granting-product-specific-waiver-propylene-glycol-urea-emea-003542-pip01-23_en.pdf"},
    {"id":"68666","name":"P/0120/2024: EMA decision of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for trimodulin (human IgM, IgA, IgG solution) (EMEA-002883-PIP03-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T15:03:53Z","last_updated_date":"2025-06-10T15:03:53Z","reference_number":"EMA/114596/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0120-2024-ema-decision-12-april-2024-agreement-paediatric-investigation-plan-granting-deferral-trimodulin-human-igm-iga-igg-solution-emea-002883-pip03-23_en.pdf"},
    {"id":"68668","name":"P/0121/2024: EMA decision of 12 April 2024 on the granting of a product specific waiver for suvecaltamide hydrochloride (EMEA-003248-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T15:17:52Z","last_updated_date":"2025-06-10T15:17:52Z","reference_number":"EMA/114623/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0121-2024-ema-decision-12-april-2024-granting-product-specific-waiver-suvecaltamide-hydrochloride-emea-003248-pip02-23_en.pdf"},
    {"id":"68669","name":"P/0122/2024: EMA decision of 11 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for iodine (131I) apamistamab (EMEA-003395-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T15:27:34Z","last_updated_date":"2025-06-10T15:27:34Z","reference_number":"EMA/142648/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0122-2024-ema-decision-11-april-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-iodine-131i-apamistamab-emea-003395-pip02-23_en.pdf"},
    {"id":"68671","name":"P/0125/2024: EMA decision of 11 April 2024 on the granting of a product specific waiver for maplirpacept (EMEA-003551-PIP01-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T15:58:26Z","last_updated_date":"2025-06-10T15:58:26Z","reference_number":"EMA/143927/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0125-2024-ema-decision-11-april-2024-granting-product-specific-waiver-maplirpacept-emea-003551-pip01-23_en.pdf"},
    {"id":"68673","name":"P/0126/2024: EMA decision of on the agreement of 12 April 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral for disitamab vedotin (EMEA-003443-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-06-10T16:08:45Z","last_updated_date":"2025-06-10T16:08:45Z","reference_number":"EMA/114598/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0126-2024-ema-decision-agreement-12-april-2024-agreement-paediatric-investigation-plan-granting-deferral-disitamab-vedotin-emea-003443-pip02-23_en.pdf"},
    {"id":"67891","name":"P/0068/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for midostaurin (Rydapt), (EMEA-000780-PIP01-09-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-25T10:43:55Z","last_updated_date":"2025-04-25T10:43:55Z","reference_number":"EMA/76785/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0068-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-midostaurin-rydapt-emea-000780-pip01-09-m07_en.pdf"},
    {"id":"67888","name":"P/0064/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for nedosiran, (EMEA- 002493-PIP01-18-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-25T10:17:07Z","last_updated_date":"2025-04-25T10:17:07Z","reference_number":"EMA/PDCO/480620/2023","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0064-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-nedosiran-emea-002493-pip01-18-m06_en.pdf"},
    {"id":"67889","name":"P/0063/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for molgramostim, (EMEA-002282-PIP01-17-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-25T10:25:32Z","last_updated_date":"2025-04-25T10:25:32Z","reference_number":"EMA/87258/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0063-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-molgramostim-emea-002282-pip01-17-m02_en.pdf"},
    {"id":"67890","name":"P/0069/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for satralizumab (Enspryng), (EMEA-001625-PIP02-21-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-25T10:31:09Z","last_updated_date":"2025-04-25T10:31:09Z","reference_number":"EMA/77109/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0069-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-satralizumab-enspryng-emea-001625-pip02-21-m03_en.pdf"},
    {"id":"67797","name":"P/0074/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for oritavancin (diphosphate) (Tenkasi), (EMEA-001270-PIP01-12-M07)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T16:10:00Z","last_updated_date":"2025-04-14T16:10:00Z","reference_number":"EMA/28203/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0074-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-oritavancin-diphosphate-tenkasi-emea-001270-pip01-12-m07_en.pdf"},
    {"id":"67796","name":"P/0076/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dinutuximab beta (Qarziba), (EMEA-001314-PIP01-12-M02)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T15:34:39Z","last_updated_date":"2025-04-14T15:34:39Z","reference_number":"EMA/89774/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0076-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-dinutuximab-beta-qarziba-emea-001314-pip01-12-m02_en.pdf"},
    {"id":"67795","name":"P/0077/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for sodium zirconium cyclosilicate (Lokelma), (EMEA-001539-PIP01-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T15:20:16Z","last_updated_date":"2025-04-14T15:20:16Z","reference_number":"EMA/89807/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0077-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-sodium-zirconium-cyclosilicate-lokelma-emea-001539-pip01-13-m06_en.pdf"},
    {"id":"67792","name":"P/0078/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for eluxadoline (EMEA- 001579-PIP01-13-M06)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T15:02:01Z","last_updated_date":"2025-04-14T15:02:01Z","reference_number":"EMA/89818/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0078-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-eluxadoline-emea-001579-pip01-13-m06_en.pdf"},
    {"id":"67789","name":"P/0075/2024 : EMA decision of 8 March 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ianalumab (EMEA-002338-PIP04-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T14:32:29Z","last_updated_date":"2025-04-14T14:32:29Z","reference_number":"EMA/89916/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0075-2024-ema-decision-8-march-2024-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-ianalumab-emea-002338-pip04-23_en.pdf"},
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    {"id":"67782","name":"P/0072/2024 : EMA decision of 8 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for SARS-CoV2 prefusion spike delta TM (CoV-2 preS dTM) adjuvanted with AS03 (VidPrevtyn Beta), (EMEA-002915-PIP01-20-M03)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T13:53:52Z","last_updated_date":"2025-04-14T13:53:52Z","reference_number":"EMA/28208/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0072-2024-ema-decision-8-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-sars-cov2-prefusion-spike-delta-tm-cov-2-pres-dtm-adjuvanted-as03-vidprevtyn-beta-emea-002915-pip01_en.pdf"},
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    {"id":"67778","name":"P/0070/2024 : EMA decision of 8 March 2024 on the granting of a product specific waiver for volrustomig (EMEA-003423-PIP02-23)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-14T12:08:19Z","last_updated_date":"2025-04-14T12:08:19Z","reference_number":"EMA/28240/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0070-2024-ema-decision-8-march-2024-granting-product-specific-waiver-volrustomig-emea-003423-pip02-23_en.pdf"},
    {"id":"67601","name":"P/0058/2024 : EMA decision of 7 March 2024 on the acceptance of a modification of an agreed paediatric investigation plan for difelikefalin (Kapruvia), (EMEA-002565-PIP02-19-M01)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-04-02T13:37:46Z","last_updated_date":"2025-04-02T13:37:46Z","reference_number":"EMA/81537/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0058-2024-ema-decision-7-march-2024-acceptance-modification-agreed-paediatric-investigation-plan-difelikefalin-kapruvia-emea-002565-pip02-19-m01_en.pdf"},
    {"id":"67472","name":"P/0045/2024 : EMA decision of 9 February 2024 on the agreement of a paediatric investigation plan and on the granting of a waiver for influenza Virus Type B, Victoria lineage / Influenza Virus Type A, H3N2 / Influenza Virus Type A, H1N1 (EMEA-003589- PIP0","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2025-03-26T16:23:23Z","last_updated_date":"2025-03-26T16:23:23Z","reference_number":"EMA/57360/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0045-2024-ema-decision-9-february-2024-agreement-paediatric-investigation-plan-granting-waiver-influenza-virus-type-b-victoria-lineage-influenza-virus-type-h3n2-influenza-virus-type-h1n1-emea-003589_en.pdf"},
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    {"id":"72543","name":"Public statement on Palforzia - cessation of marketing in the European Union","type":"public-statement","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T16:50:00Z","last_updated_date":"2026-02-12T16:50:00Z","reference_number":"EMA/CHMP/38464/2025","document_url":"https://www.ema.europa.eu/en/documents/public-statement/public-statement-palforzia-cessation-marketing-european-union_en.pdf"},
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    {"id":"69965","name":"Levamisole-containing medicinal products Article-31 referral - PRAC starts safety review of levamisole, a medicine used to treat parasitic worm infections","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-09-05T12:23:29Z","last_updated_date":"2025-09-05T12:23:29Z","reference_number":"EMA/281577/2025","document_url":"https://www.ema.europa.eu/en/documents/referral/levamisole-containing-medicinal-products-article-31-referral-prac-starts-safety-review-levamisole-medicine-used-treat-parasitic-worm-infections_en.pdf"},
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    {"id":"72558","name":"Highlights - 6th EMA-AESGP bilateral meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2026-02-13T15:25:34Z","last_updated_date":"2026-02-13T15:25:34Z","reference_number":"EMA/5438/2026","document_url":"https://www.ema.europa.eu/en/documents/report/highlights-6th-ema-aesgp-bilateral-meeting_en.pdf"},
    {"id":"72551","name":"CVMP summary of positive opinion for Emepax","type":"smop-initial","status":"unknown","consultation_date":"","first_published_date":"2026-02-13T12:16:42Z","last_updated_date":"2026-02-13T12:16:42Z","reference_number":"EMA/CVMP/25902/2026","document_url":"https://www.ema.europa.eu/en/documents/smop-initial/cvmp-summary-positive-opinion-emepax_en.pdf"},
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    {"id":"70421","name":"VICH GL62 on target animal safety of veterinary monoclonal antibody products (VMAPs)","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-09-15 - 2026-02-15","first_published_date":"2025-09-15T16:42:10Z","last_updated_date":"2025-09-15T16:42:10Z","reference_number":"EMA/CVMP/VICH/250843/2021","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/vich-gl62-target-animal-safety-veterinary-monoclonal-antibody-products-vmaps_en.pdf"},
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    {"id":"72565","name":"PDCO minutes of the 9-12 December 2025 meeting","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2026-02-16T10:30:17Z","last_updated_date":"2026-02-16T10:30:17Z","reference_number":"EMA/PDCO/6360/2026","document_url":"https://www.ema.europa.eu/en/documents/minutes/pdco-minutes-9-12-december-2025-meeting_en.xlsx"},
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    {"id":"69044","name":"ICH E20 guideline on adaptive designs for clinical trials - Step 2b","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-06-30 - 2025-11-30","first_published_date":"2025-06-30T12:32:45Z","last_updated_date":"2025-06-30T12:32:45Z","reference_number":"EMA/CHMP/ICH/206586/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e20-guideline-adaptive-designs-clinical-trials-step-2b_en.pdf"},
    {"id":"72323","name":"Overview of comments received on Q&A regarding co-processed excipients used in solid oral dosage forms H and V (EMA/CHMP/CVMP/QWP/422493/2024)","type":"comments","status":"unknown","consultation_date":"","first_published_date":"2026-01-28T13:59:22Z","last_updated_date":"2026-02-16T11:18:00Z","reference_number":"EMA/382821/2025","document_url":"https://www.ema.europa.eu/en/documents/comments/overview-comments-received-qa-regarding-co-processed-excipients-used-solid-oral-dosage-forms-h-v-ema-chmp-cvmp-qwp-422493-2024_en.xlsx"},
    {"id":"72571","name":"Agenda of the COMP meeting 17-19 February 2026","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2026-02-16T15:24:45Z","last_updated_date":"2026-02-16T15:24:45Z","reference_number":"EMA/COMP/21379/2026","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-comp-meeting-17-19-february-2026_en.xlsx"},
    {"id":"69839","name":"Minutes of the CHMP meeting 19-22 May 2025","type":"minutes","status":"unknown","consultation_date":"","first_published_date":"2025-08-21T16:13:56Z","last_updated_date":"2026-02-16T17:22:04Z","reference_number":"EMA/206317/2025 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-19-22-may-2025_en.pdf"},
    {"id":"72518","name":"Minutes of the CHMP meeting 21-24 July 2025","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2026-02-11T17:22:35Z","last_updated_date":"2026-02-16T17:23:11Z","reference_number":"EMA/CHMP/319030/2025 Corr.1","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-chmp-meeting-21-24-july-2025_en.pdf"},
    {"id":"72578","name":"Agenda - Medicine Shortages SPOC Working Party meeting 17 February 2026","type":"agenda","status":"Adopted","consultation_date":"","first_published_date":"2026-02-17T10:11:55Z","last_updated_date":"2026-02-17T10:11:55Z","reference_number":"EMA/13780/2026","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-medicine-shortages-spoc-working-party-meeting-17-february-2026_en.pdf"},
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    {"id":"72585","name":"Meeting report - ACT EU multi-stakeholder platform annual meeting","type":"report","status":"unknown","consultation_date":"","first_published_date":"2026-02-17T17:00:53Z","last_updated_date":"2026-02-17T17:00:53Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/report/meeting-report-act-eu-multi-stakeholder-platform-annual-meeting_en.pdf-0"},
    {"id":"62475","name":"Vaccine Monitoring Platform: List of EMA-funded studies","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-03-07T15:40:32Z","last_updated_date":"2026-02-18T08:32:43Z","reference_number":"EXT/261018/2025","document_url":"https://www.ema.europa.eu/en/documents/other/vaccine-monitoring-platform-list-ema-funded-studies_en.pdf"},
    {"id":"72590","name":"Agenda of the CAT meeting 18-20 February 2026","type":"agenda","status":"unknown","consultation_date":"","first_published_date":"2026-02-18T15:05:20Z","last_updated_date":"2026-02-18T15:05:20Z","reference_number":"EMA/CAT/40771/2026","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-18-20-february-2026_en.pdf"},
    {"id":"72584","name":"Amlodipine/irbesartan : List of nationally authorised medicinal products - PSUSA/00010876/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-17T15:49:02Z","last_updated_date":"2026-02-17T15:49:02Z","reference_number":"EMADOC-1700519818-2916886","document_url":"https://www.ema.europa.eu/en/documents/psusa/amlodipine-irbesartan-list-nationally-authorised-medicinal-products-psusa-00010876-202506_en.pdf"},
    {"id":"72574","name":"Nitrous oxide, nitrous oxide / oxygen : List of nationally authorised medicinal products - PSUSA/00010572/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-16T16:15:46Z","last_updated_date":"2026-02-16T16:15:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/nitrous-oxide-nitrous-oxide-oxygen-list-nationally-authorised-medicinal-products-psusa-00010572-202506_en.pdf"},
    {"id":"72573","name":"Itopride : List of nationally authorised medicinal products - PSUSA/00010606/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-16T16:10:56Z","last_updated_date":"2026-02-16T16:10:56Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/itopride-list-nationally-authorised-medicinal-products-psusa-00010606-202506_en.pdf"},
    {"id":"72562","name":"Alfacalcidol : List of nationally authorised medicinal products - PSUSA/00000080/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-16T08:59:45Z","last_updated_date":"2026-02-16T08:59:45Z","reference_number":"EMADOC-1700519818-2913530","document_url":"https://www.ema.europa.eu/en/documents/psusa/alfacalcidol-list-nationally-authorised-medicinal-products-psusa-00000080-202506_en.pdf"},
    {"id":"72540","name":"Mitoxantrone : List of nationally authorised medicinal products - PSUSA/00002076/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T16:20:11Z","last_updated_date":"2026-02-12T16:20:11Z","reference_number":"EMADOC-1700519818-2913321","document_url":"https://www.ema.europa.eu/en/documents/psusa/mitoxantrone-list-nationally-authorised-medicinal-products-psusa-00002076-202506_en.pdf"},
    {"id":"72539","name":"Clonazepam : List of nationally authorised medicinal products - PSUSA/00000812/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T16:15:13Z","last_updated_date":"2026-02-12T16:15:13Z","reference_number":"EMADOC-1700519818-2913239","document_url":"https://www.ema.europa.eu/en/documents/psusa/clonazepam-list-nationally-authorised-medicinal-products-psusa-00000812-202506_en.pdf"},
    {"id":"72537","name":"Rifabutin : List of nationally authorised medicinal products - PSUSA/00002639/202507","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T15:23:30Z","last_updated_date":"2026-02-12T15:23:30Z","reference_number":"EMADOC-1700519818-2859748","document_url":"https://www.ema.europa.eu/en/documents/psusa/rifabutin-list-nationally-authorised-medicinal-products-psusa-00002639-202507_en.pdf"},
    {"id":"72534","name":"Ganciclovir : List of nationally authorised medicinal products - PSUSA/00001516/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T14:38:24Z","last_updated_date":"2026-02-12T14:38:24Z","reference_number":"EMADOC-1700519818-2912667","document_url":"https://www.ema.europa.eu/en/documents/psusa/ganciclovir-list-nationally-authorised-medicinal-products-psusa-00001516-202506_en.pdf"},
    {"id":"72533","name":"Misoprostol (gastrointestinal indication) : EPAR - List of nationally authorised medicinal products - PSUSA/00010291/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T13:19:58Z","last_updated_date":"2026-02-12T13:19:58Z","reference_number":"EMADOC-1700519818-2867091","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gastrointestinal-indication-epar-list-nationally-authorised-medicinal-products-psusa-00010291-202506_en.pdf"},
    {"id":"72520","name":"Testosterone (topical use) : List of nationally authorised medicinal products - PSUSA/00002908/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-12T08:44:24Z","last_updated_date":"2026-02-12T08:44:24Z","reference_number":"EMADOC-1700519818-2124174","document_url":"https://www.ema.europa.eu/en/documents/psusa/testosterone-topical-use-list-nationally-authorised-medicinal-products-psusa-00002908-202412_en.pdf"},
    {"id":"72511","name":"Chlorhexidine : List of nationally authorised medicinal products - PSUSA/00000662/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-11T14:04:28Z","last_updated_date":"2026-02-11T14:04:28Z","reference_number":"EMADOC-1700519818-2901423","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorhexidine-list-nationally-authorised-medicinal-products-psusa-00000662-202503_en.pdf"},
    {"id":"72447","name":"Tranexamic acid : List of nationally authorised medicinal products - PSUSA/00003006/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-06T14:15:54Z","last_updated_date":"2026-02-06T14:15:54Z","reference_number":"EMADOC-1700519818-2852321","document_url":"https://www.ema.europa.eu/en/documents/psusa/tranexamic-acid-list-nationally-authorised-medicinal-products-psusa-00003006-202503_en.pdf"},
    {"id":"72398","name":"Valsartan, hydrochlorothiazide / valsartan : List of nationally authorised medicinal products - PSUSA/00010396/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-30T17:16:53Z","last_updated_date":"2026-01-30T17:16:53Z","reference_number":"EMADOC-1700519818-2873421","document_url":"https://www.ema.europa.eu/en/documents/psusa/valsartan-hydrochlorothiazide-valsartan-list-nationally-authorised-medicinal-products-psusa-00010396-202504_en.pdf"},
    {"id":"72397","name":"Cefaclor : List of nationally authorised medicinal products - PSUSA/00000583/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-30T17:13:53Z","last_updated_date":"2026-01-30T17:13:53Z","reference_number":"EMADOC-1700519818-2560536","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefaclor-list-nationally-authorised-medicinal-products-psusa-00000583-202503_en.pdf"},
    {"id":"72344","name":"Cytarabine : List of nationally authorised medicinal products - PSUSA/00000911/202503 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-29T12:36:04Z","last_updated_date":"2026-01-29T12:36:04Z","reference_number":"EMADOC-1700519818-2680252","document_url":"https://www.ema.europa.eu/en/documents/psusa/cytarabine-list-nationally-authorised-medicinal-products-psusa-00000911-202503_en.pdf"},
    {"id":"72339","name":"Linezolid : List of nationally authorised medicinal products - PSUSA/00001888/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-29T10:24:32Z","last_updated_date":"2026-01-29T10:24:32Z","reference_number":"EMADOC-1700519818-2864496","document_url":"https://www.ema.europa.eu/en/documents/psusa/linezolid-list-nationally-authorised-medicinal-products-psusa-00001888-202504_en.pdf"},
    {"id":"72300","name":"Dienogest / ethinylestradiol (prolonged-release tablet) : List of nationally authorised medicinal products - PSUSA/00011084/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T16:14:10Z","last_updated_date":"2026-01-27T16:14:10Z","reference_number":"EMADOC-1700519818-2862062","document_url":"https://www.ema.europa.eu/en/documents/psusa/dienogest-ethinylestradiol-prolonged-release-tablet-list-nationally-authorised-medicinal-products-psusa-00011084-202503_en.pdf"},
    {"id":"72297","name":"Formoterol : List of nationally authorised medicinal products - PSUSA/00001469/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T15:18:53Z","last_updated_date":"2026-01-27T15:18:53Z","reference_number":"EMADOC-1700519818-2860495","document_url":"https://www.ema.europa.eu/en/documents/psusa/formoterol-list-nationally-authorised-medicinal-products-psusa-00001469-202505_en.pdf"},
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    {"id":"72287","name":"Metolazone : List of nationally authorised medicinal products - PSUSA/00002037/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T11:50:05Z","last_updated_date":"2026-01-27T11:50:05Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/metolazone-list-nationally-authorised-medicinal-products-psusa-00002037-202506_en.pdf"},
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    {"id":"72284","name":"Nefopam : List of nationally authorised medicinal products - PSUSA/00002131/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T11:31:13Z","last_updated_date":"2026-01-27T11:31:13Z","reference_number":"EMADOC-1700519818-2845165","document_url":"https://www.ema.europa.eu/en/documents/psusa/nefopam-list-nationally-authorised-medicinal-products-psusa-00002131-202503_en.pdf"},
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    {"id":"72273","name":"Zotepine : List of nationally authorised medicinal products - PSUSA/00003154/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T10:27:59Z","last_updated_date":"2026-01-27T10:27:59Z","reference_number":"EMADOC-1700519818-2842460","document_url":"https://www.ema.europa.eu/en/documents/psusa/zotepine-list-nationally-authorised-medicinal-products-psusa-00003154-202505_en.pdf"},
    {"id":"72270","name":"Gadopentetic acid : List of nationally authorised medicinal products - PSUSA/00001504/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T10:14:38Z","last_updated_date":"2026-01-27T10:14:38Z","reference_number":"EMADOC-1700519818-2840055","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadopentetic-acid-list-nationally-authorised-medicinal-products-psusa-00001504-202504_en.pdf"},
    {"id":"72272","name":"Gadoxetic acid disodium : List of nationally authorised medicinal products - PSUSA/00001509/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-27T10:22:49Z","last_updated_date":"2026-01-27T10:22:49Z","reference_number":"EMADOC-1700519818-2840430","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoxetic-acid-disodium-list-nationally-authorised-medicinal-products-psusa-00001509-202504_en.pdf"},
    {"id":"72266","name":"Gadodiamide : List of nationally authorised medicinal products - PSUSA/00001503/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-26T17:52:16Z","last_updated_date":"2026-01-26T17:52:16Z","reference_number":"EMADOC-1700519818-2839132","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadodiamide-list-nationally-authorised-medicinal-products-psusa-00001503-202504_en.pdf"},
    {"id":"72265","name":"Gadobutrol : List of nationally authorised medicinal products - PSUSA/00001502/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-26T17:48:04Z","last_updated_date":"2026-01-26T17:48:04Z","reference_number":"EMADOC-1700519818-2839073","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadobutrol-list-nationally-authorised-medicinal-products-psusa-00001502-202504_en.pdf"},
    {"id":"72250","name":"Piritramide : List of nationally authorised medicinal products - PSUSA/00002437/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-26T13:20:00Z","last_updated_date":"2026-01-26T13:20:00Z","reference_number":"EMADOC-1700519818-2837474","document_url":"https://www.ema.europa.eu/en/documents/psusa/piritramide-list-nationally-authorised-medicinal-products-psusa-00002437-202503_en.pdf"},
    {"id":"72231","name":"Gadoteric acid : List of nationally authorised medicinal products - PSUSA/00001505/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-23T15:57:44Z","last_updated_date":"2026-01-23T15:57:44Z","reference_number":"EMADOC-1700519818-2835294","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteric-acid-list-nationally-authorised-medicinal-products-psusa-00001505-202504_en.pdf"},
    {"id":"72232","name":"Fotemustine : List of nationally authorised medicinal products - PSUSA/00001477/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-23T16:07:35Z","last_updated_date":"2026-01-23T16:07:35Z","reference_number":"EMADOC-1700519818-2835361","document_url":"https://www.ema.europa.eu/en/documents/psusa/fotemustine-list-nationally-authorised-medicinal-products-psusa-00001477-202506_en.pdf"},
    {"id":"72234","name":"Magnesium pidolate : List of nationally authorised medicinal products - PSUSA/00010041/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-23T16:40:34Z","last_updated_date":"2026-01-23T16:40:34Z","reference_number":"EMADOC-1700519818-2836274","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-pidolate-list-nationally-authorised-medicinal-products-psusa-00010041-202506_en.pdf"},
    {"id":"72233","name":"Ticlopidine : List of nationally authorised medicinal products - PSUSA/00002952/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-23T16:30:56Z","last_updated_date":"2026-01-23T16:30:56Z","reference_number":"EMADOC-1700519818-2835600","document_url":"https://www.ema.europa.eu/en/documents/psusa/ticlopidine-list-nationally-authorised-medicinal-products-psusa-00002952-202505_en.pdf"},
    {"id":"72238","name":"Sertaconazole : List of nationally authorised medicinal products - PSUSA/00002694/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-23T17:01:44Z","last_updated_date":"2026-01-23T17:01:44Z","reference_number":"EMADOC-1700519818-2836977","document_url":"https://www.ema.europa.eu/en/documents/psusa/sertaconazole-list-nationally-authorised-medicinal-products-psusa-00002694-202506_en.pdf"},
    {"id":"72189","name":"Benzoyl peroxide / clindamycin phosphate : List of nationally authorised medicinal products - PSUSA/00000796/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T14:52:15Z","last_updated_date":"2026-01-21T14:52:15Z","reference_number":"EMADOC-1700519818-2834195","document_url":"https://www.ema.europa.eu/en/documents/psusa/benzoyl-peroxide-clindamycin-phosphate-list-nationally-authorised-medicinal-products-psusa-00000796-202505_en.pdf"},
    {"id":"72126","name":"Somatostatin : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002771/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-19T11:30:29Z","last_updated_date":"2026-01-19T11:30:29Z","reference_number":"EMADOC-1700519818-2832272","document_url":"https://www.ema.europa.eu/en/documents/psusa/somatostatin-cmdh-scientific-conclusions-grounds-variation-amendments-product-information-timetable-implementation-psusa-00002771-202506_en.pdf"},
    {"id":"72174","name":"Gadoteric acid (IV and intravascular formulations) : List of nationally authorised medicinal products - PSUSA/00001506/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-20T16:49:03Z","last_updated_date":"2026-01-20T16:49:03Z","reference_number":"EMADOC-1700519818-2834040","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteric-acid-iv-intravascular-formulations-list-nationally-authorised-medicinal-products-psusa-00001506-202504_en.pdf"},
    {"id":"72180","name":"Indobufen : List of nationally authorised medicinal products - PSUSA/00001736/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T13:08:54Z","last_updated_date":"2026-01-21T13:08:54Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/indobufen-list-nationally-authorised-medicinal-products-psusa-00001736-202505_en.pdf"},
    {"id":"72184","name":"Levonorgestrel : List of nationally authorised medicinal products - PSUSA/00010827/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T14:20:59Z","last_updated_date":"2026-01-21T14:20:59Z","reference_number":"EMADOC-1700519818-2834160","document_url":"https://www.ema.europa.eu/en/documents/psusa/levonorgestrel-list-nationally-authorised-medicinal-products-psusa-00010827-202505_en.pdf"},
    {"id":"72182","name":"Nicergoline : List of nationally authorised medicinal products - PSUSA/00002150/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T14:09:29Z","last_updated_date":"2026-01-21T14:09:29Z","reference_number":"EMADOC-1700519818-2834090","document_url":"https://www.ema.europa.eu/en/documents/psusa/nicergoline-list-nationally-authorised-medicinal-products-psusa-00002150-202505_en.pdf"},
    {"id":"72186","name":"Methoxyflurane : List of nationally authorised medicinal products - PSUSA/00010484/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T14:46:03Z","last_updated_date":"2026-01-21T14:46:03Z","reference_number":"EMADOC-1700519818-2834218","document_url":"https://www.ema.europa.eu/en/documents/psusa/methoxyflurane-list-nationally-authorised-medicinal-products-psusa-00010484-202505_en.pdf"},
    {"id":"72193","name":"Levofloxacin/dexamethasone (ocular use) : List of nationally authorised medicinal products - PSUSA/00010881/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T14:58:08Z","last_updated_date":"2026-01-21T14:58:08Z","reference_number":"EMADOC-1700519818-2834304","document_url":"https://www.ema.europa.eu/en/documents/psusa/levofloxacin-dexamethasone-ocular-use-list-nationally-authorised-medicinal-products-psusa-00010881-202506_en.pdf"},
    {"id":"72194","name":"Azelaic acid : List of nationally authorised medicinal products - PSUSA/00000276/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T15:04:01Z","last_updated_date":"2026-01-21T15:04:01Z","reference_number":"EMADOC-1700519818-2834306","document_url":"https://www.ema.europa.eu/en/documents/psusa/azelaic-acid-list-nationally-authorised-medicinal-products-psusa-00000276-202506_en.pdf"},
    {"id":"72195","name":"Solifenacin : List of nationally authorised medicinal products - PSUSA/00002769/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-21T15:07:42Z","last_updated_date":"2026-01-21T15:07:42Z","reference_number":"EMADOC-1700519818-2834394","document_url":"https://www.ema.europa.eu/en/documents/psusa/solifenacin-list-nationally-authorised-medicinal-products-psusa-00002769-202506_en.pdf"},
    {"id":"72099","name":"Bifonazole : List of nationally authorised medicinal products - PSUSA/00000411/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:40:58Z","last_updated_date":"2026-01-16T10:40:58Z","reference_number":"EMADOC-1700519818-2831274","document_url":"https://www.ema.europa.eu/en/documents/psusa/bifonazole-list-nationally-authorised-medicinal-products-psusa-00000411-202505_en.pdf"},
    {"id":"72098","name":"Fusidic acid (systemic use) : List of nationally authorised medicinal products - PSUSA/00010226/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:36:22Z","last_updated_date":"2026-01-16T10:36:22Z","reference_number":"EMADOC-1700519818-2830896","document_url":"https://www.ema.europa.eu/en/documents/psusa/fusidic-acid-systemic-use-list-nationally-authorised-medicinal-products-psusa-00010226-202505_en.pdf"},
    {"id":"72097","name":"Diphtheria / tetanus vaccines (adsorbed), diphtheria vaccines (adsorbed) : List of nationally authorised medicinal products - PSUSA/00001128/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:31:47Z","last_updated_date":"2026-01-16T10:31:47Z","reference_number":"EMADOC-1700519818-2830891","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheria-tetanus-vaccines-adsorbed-diphtheria-vaccines-adsorbed-list-nationally-authorised-medicinal-products-psusa-00001128-202505_en.pdf"},
    {"id":"72096","name":"Ozenoxacin : List of nationally authorised medicinal products - PSUSA/00010651/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:25:54Z","last_updated_date":"2026-01-16T10:25:54Z","reference_number":"EMADOC-1700519818-2830723","document_url":"https://www.ema.europa.eu/en/documents/psusa/ozenoxacin-list-nationally-authorised-medicinal-products-psusa-00010651-202505_en.pdf"},
    {"id":"72095","name":"Rifaximin : List of nationally authorised medicinal products - PSUSA/00002642/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:23:06Z","last_updated_date":"2026-01-16T10:23:06Z","reference_number":"EMADOC-1700519818-2824520","document_url":"https://www.ema.europa.eu/en/documents/psusa/rifaximin-list-nationally-authorised-medicinal-products-psusa-00002642-202505_en.pdf"},
    {"id":"72094","name":"Mebendazole : List of nationally authorised medicinal products - PSUSA/00001939/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:20:25Z","last_updated_date":"2026-01-16T10:20:25Z","reference_number":"EMADOC-1700519818-2829891","document_url":"https://www.ema.europa.eu/en/documents/psusa/mebendazole-list-nationally-authorised-medicinal-products-psusa-00001939-202505_en.pdf"},
    {"id":"72093","name":" Fenticonazole : List of nationally authorised medicinal products -  PSUSA/00001371/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:16:35Z","last_updated_date":"2026-01-16T10:16:35Z","reference_number":"EMADOC-1700519818-2829886","document_url":"https://www.ema.europa.eu/en/documents/psusa/fenticonazole-list-nationally-authorised-medicinal-products-psusa-00001371-202506_en.pdf"},
    {"id":"72092","name":"Lodoxamide : List of nationally authorised medicinal products - PSUSA/00001898/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-16T10:12:17Z","last_updated_date":"2026-01-16T10:12:17Z","reference_number":"EMADOC-1700519818-2593298","document_url":"https://www.ema.europa.eu/en/documents/psusa/lodoxamide-list-nationally-authorised-medicinal-products-psusa-00001898-202506_en.pdf"},
    {"id":"72075","name":"Misoprostol (gynaecological indication - labour induction) : List of nationally authorised medicinal products - PSUSA/00010353/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T15:40:26Z","last_updated_date":"2026-01-15T15:40:26Z","reference_number":"EMADOC-1700519818-2829509","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gynaecological-indication-labour-induction-list-nationally-authorised-medicinal-products-psusa-00010353-202505_en.pdf"},
    {"id":"72073","name":"Clotiazepam : List of nationally authorised medicinal products - PSUSA/00000827/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T15:37:15Z","last_updated_date":"2026-01-15T15:37:15Z","reference_number":"EMADOC-1700519818-2825353","document_url":"https://www.ema.europa.eu/en/documents/psusa/clotiazepam-list-nationally-authorised-medicinal-products-psusa-00000827-202505_en.pdf"},
    {"id":"72070","name":"Ciprofloxacin / dexamethasone (ear drops, suspension) : List of nationally authorised medicinal products - PSUSA/00010012/202504","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T15:32:29Z","last_updated_date":"2026-01-15T15:32:29Z","reference_number":"EMADOC-1700519818-2824467","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciprofloxacin-dexamethasone-ear-drops-suspension-list-nationally-authorised-medicinal-products-psusa-00010012-202504_en.pdf"},
    {"id":"72069","name":"Ceftriaxone sodium / lidocaine hydrochloride : List of nationally authorised medicinal products - PSUSA/00000614/202505","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T15:17:04Z","last_updated_date":"2026-01-15T15:17:04Z","reference_number":"EMADOC-1700519818-2828744","document_url":"https://www.ema.europa.eu/en/documents/psusa/ceftriaxone-sodium-lidocaine-hydrochloride-list-nationally-authorised-medicinal-products-psusa-00000614-202505_en.pdf"},
    {"id":"72067","name":"Carmellose (eye preparation) : List of nationally authorised medicinal products - PSUSA/00000562/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T14:40:39Z","last_updated_date":"2026-01-15T14:40:39Z","reference_number":"EMADOC-1700519818-2828413","document_url":"https://www.ema.europa.eu/en/documents/psusa/carmellose-eye-preparation-list-nationally-authorised-medicinal-products-psusa-00000562-202506_en.pdf"},
    {"id":"72066","name":"Etamsylate : List of nationally authorised medicinal products - PSUSA/00001294/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T14:36:37Z","last_updated_date":"2026-01-15T14:36:37Z","reference_number":"EMADOC-1700519818-2783294","document_url":"https://www.ema.europa.eu/en/documents/psusa/etamsylate-list-nationally-authorised-medicinal-products-psusa-00001294-202506_en.pdf"},
    {"id":"72065","name":"Calcipotriol : List of nationally authorised medicinal products - PSUSA/00000492/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T14:33:06Z","last_updated_date":"2026-01-15T14:33:06Z","reference_number":"EMADOC-1700519818-2783116","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcipotriol-list-nationally-authorised-medicinal-products-psusa-00000492-202506_en.pdf"},
    {"id":"72063","name":"Cefditoren : List of nationally authorised medicinal products - PSUSA/00000592/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-15T14:25:55Z","last_updated_date":"2026-01-15T14:25:55Z","reference_number":"EMADOC-1700519818-2828091","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefditoren-list-nationally-authorised-medicinal-products-psusa-00000592-202503_en.pdf"},
    {"id":"72049","name":"Codeine / paracetamol : List of nationally authorised medicinal products - PSUSA/00000851/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-14T16:17:07Z","last_updated_date":"2026-01-14T16:17:07Z","reference_number":"EMADOC-1700519818-2822399","document_url":"https://www.ema.europa.eu/en/documents/psusa/codeine-paracetamol-list-nationally-authorised-medicinal-products-psusa-00000851-202503_en.pdf"},
    {"id":"71994","name":"Clomipramine : List of nationally authorised medicinal products - PSUSA/00000811/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-01-08T15:41:02Z","last_updated_date":"2026-01-08T15:41:02Z","reference_number":"EMADOC-1700519818-2804911","document_url":"https://www.ema.europa.eu/en/documents/psusa/clomipramine-list-nationally-authorised-medicinal-products-psusa-00000811-202503_en.pdf"},
    {"id":"72596","name":"Magnesium sulfate : List of nationally authorised medicinal products - PSUSA/00009225/202506","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2026-02-19T09:41:36Z","last_updated_date":"2026-02-19T09:41:36Z","reference_number":"EMADOC-1700519818-2919760","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-sulfate-list-nationally-authorised-medicinal-products-psusa-00009225-202506_en.pdf"},
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    {"id":"70795","name":"Botulinum neurotoxin type a (150 kd) free from complexing proteins : List of nationally authorised medicinal products - PSUSA/00009084/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-23T17:52:23Z","last_updated_date":"2025-10-23T17:52:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/botulinum-neurotoxin-type-150-kd-free-complexing-proteins-list-nationally-authorised-medicinal-products-psusa-00009084-202412_en.pdf"},
    {"id":"70797","name":"Dexketoprofen / tramadol : List of nationally authorised medicinal products - PSUSA/00010468/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-23T17:59:39Z","last_updated_date":"2025-10-23T17:59:39Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexketoprofen-tramadol-list-nationally-authorised-medicinal-products-psusa-00010468-202501_en.pdf"},
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    {"id":"70966","name":"Ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00001306/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-31T12:05:36Z","last_updated_date":"2025-10-31T12:05:36Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethinylestradiol-list-nationally-authorised-medicinal-products-psusa-00001306-202503_en.pdf"},
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    {"id":"70968","name":"Niflumic acid : List of nationally authorised medicinal products - PSUSA/00002157/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-31T12:14:46Z","last_updated_date":"2025-10-31T12:14:46Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/niflumic-acid-list-nationally-authorised-medicinal-products-psusa-00002157-202412_en.pdf"},
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    {"id":"70975","name":"Hepatitis B vaccine (rDNA) : List of nationally authorised medicinal products - PSUSA/00001597/202502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-11-03T11:26:21Z","last_updated_date":"2025-11-03T11:26:21Z","reference_number":"EMADOC-1700519818-2550366","document_url":"https://www.ema.europa.eu/en/documents/psusa/hepatitis-b-vaccine-rdna-list-nationally-authorised-medicinal-products-psusa-00001597-202502_en.pdf"},
    {"id":"70973","name":"Bupropion : List of nationally authorised medicinal products - PSUSA/00000461/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-11-03T11:20:02Z","last_updated_date":"2025-11-03T11:20:02Z","reference_number":"EMADOC-1700519818-2576258","document_url":"https://www.ema.europa.eu/en/documents/psusa/bupropion-list-nationally-authorised-medicinal-products-psusa-00000461-202412_en.pdf"},
    {"id":"70548","name":"Sevoflurane : List of nationally authorised medicinal products - PSUSA/00002698/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-14T15:27:02Z","last_updated_date":"2025-10-14T15:27:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/sevoflurane-list-nationally-authorised-medicinal-products-psusa-00002698-202501_en.pdf"},
    {"id":"70469","name":"Potassium para-aminobenzoate : List of nationally authorised medicinal products - PSUSA/00010130/202502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-07T12:26:01Z","last_updated_date":"2025-10-07T12:26:01Z","reference_number":"EMADOC-1700519818-2504076","document_url":"https://www.ema.europa.eu/en/documents/psusa/potassium-para-aminobenzoate-list-nationally-authorised-medicinal-products-psusa-00010130-202502_en.pdf"},
    {"id":"70453","name":"Pimozide : List of nationally authorised medicinal products - PSUSA/00002413/202502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-06T11:48:07Z","last_updated_date":"2025-10-06T11:48:07Z","reference_number":"EMADOC-1700519818-2502815","document_url":"https://www.ema.europa.eu/en/documents/psusa/pimozide-list-nationally-authorised-medicinal-products-psusa-00002413-202502_en.pdf"},
    {"id":"70450","name":"Warfarin : List of nationally authorised medicinal products - PSUSA/00003129/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-06T10:37:13Z","last_updated_date":"2025-10-06T10:37:13Z","reference_number":"EMADOC-1700519818-2501966","document_url":"https://www.ema.europa.eu/en/documents/psusa/warfarin-list-nationally-authorised-medicinal-products-psusa-00003129-202501_en.pdf"},
    {"id":"70443","name":"Hydroxyethyl starch / sodium chloride : List of nationally authorised medicinal products - PSUSA/00001694/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T16:02:27Z","last_updated_date":"2025-10-03T16:02:27Z","reference_number":"EMADOC-1700519818-2501566","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxyethyl-starch-sodium-chloride-list-nationally-authorised-medicinal-products-psusa-00001694-202503_en.pdf"},
    {"id":"70431","name":"Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202503","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:41:01Z","last_updated_date":"2025-10-03T09:41:01Z","reference_number":"EMADOC-1700519818-2497282","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa-00001744-202503_en.pdf"},
    {"id":"70430","name":"Mesterolone : List of nationally authorised medicinal products - PSUSA/00010551/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:37:53Z","last_updated_date":"2025-10-03T09:37:53Z","reference_number":"EMADOC-1700519818-2498333","document_url":"https://www.ema.europa.eu/en/documents/psusa/mesterolone-list-nationally-authorised-medicinal-products-psusa-00010551-202501_en.pdf"},
    {"id":"70428","name":"Xipamide, triamterene / xipamide : List of nationally authorised medicinal products - PSUSA/00003133/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:35:03Z","last_updated_date":"2025-10-03T09:35:03Z","reference_number":"EMADOC-1700519818-2497792","document_url":"https://www.ema.europa.eu/en/documents/psusa/xipamide-triamterene-xipamide-list-nationally-authorised-medicinal-products-psusa-00003133-202501_en.pdf"},
    {"id":"70426","name":"Lorazepam : List of nationally authorised medicinal products - PSUSA/00001909/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:31:21Z","last_updated_date":"2025-10-03T09:31:21Z","reference_number":"EMADOC-1700519818-2498095","document_url":"https://www.ema.europa.eu/en/documents/psusa/lorazepam-list-nationally-authorised-medicinal-products-psusa-00001909-202501_en.pdf"},
    {"id":"70425","name":"Lisdexamfetamine : List of nationally authorised medicinal products - PSUSA/00010289/202502","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:28:28Z","last_updated_date":"2025-10-03T09:28:28Z","reference_number":"EMADOC-1700519818-2497675","document_url":"https://www.ema.europa.eu/en/documents/psusa/lisdexamfetamine-list-nationally-authorised-medicinal-products-psusa-00010289-202502_en.pdf"},
    {"id":"70424","name":"Tofisopam : List of nationally authorised medicinal products - PSUSA/00002982/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:25:40Z","last_updated_date":"2025-10-03T09:25:40Z","reference_number":"EMADOC-1700519818-2497511","document_url":"https://www.ema.europa.eu/en/documents/psusa/tofisopam-list-nationally-authorised-medicinal-products-psusa-00002982-202501_en.pdf"},
    {"id":"70423","name":"Cyclophosphamide : List of nationally authorised medicinal products - PSUSA/00000901/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-03T09:22:11Z","last_updated_date":"2025-10-03T09:22:11Z","reference_number":"EMADOC-1700519818-2421448","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyclophosphamide-list-nationally-authorised-medicinal-products-psusa-00000901-202501_en.pdf"},
    {"id":"70420","name":"Interferon gamma : List of nationally authorised medicinal products - PSUSA/00001760/202501 - ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T16:33:51Z","last_updated_date":"2025-10-02T16:33:51Z","reference_number":"EMADOC-1700519818-2469030","document_url":"https://www.ema.europa.eu/en/documents/psusa/interferon-gamma-list-nationally-authorised-medicinal-products-psusa-00001760-202501_en.pdf"},
    {"id":"70411","name":"Diamorphine : List of nationally authorised medicinal products - PSUSA/00001028/202411 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-10-02T15:52:10Z","last_updated_date":"2025-10-02T15:52:10Z","reference_number":"EMADOC-1700519818-2435364","document_url":"https://www.ema.europa.eu/en/documents/psusa/diamorphine-list-nationally-authorised-medicinal-products-psusa-00001028-202411_en.pdf"},
    {"id":"70234","name":"Flumazenil : List of nationally authorised medicinal products - PSUSA/00000427/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-23T16:13:27Z","last_updated_date":"2025-09-23T16:13:27Z","reference_number":"PSUSA/00001413/202412","document_url":"https://www.ema.europa.eu/en/documents/psusa/flumazenil-list-nationally-authorised-medicinal-products-psusa-00000427-202412_en.pdf"},
    {"id":"70233","name":"Haloperidol  : List of nationally authorised medicinal products - PSUSA/00001587/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-23T15:59:38Z","last_updated_date":"2025-09-23T15:59:38Z","reference_number":"EMADOC-1700519818-2463062","document_url":"https://www.ema.europa.eu/en/documents/psusa/haloperidol-list-nationally-authorised-medicinal-products-psusa-00001587-202501_en.pdf"},
    {"id":"70076","name":"Phosphocreatine : List of nationally authorised medicinal products - PSUSA/00002398/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-12T16:23:47Z","last_updated_date":"2025-09-12T16:23:47Z","reference_number":"EMADOC-1700519818-2433422","document_url":"https://www.ema.europa.eu/en/documents/psusa/phosphocreatine-list-nationally-authorised-medicinal-products-psusa-00002398-202411_en.pdf"},
    {"id":"70073","name":"Cyanocobalamin / diclofenac / pyridoxine / thiamine : List of nationally authorised medicinal products - PSUSA/00001041/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-12T12:00:44Z","last_updated_date":"2025-09-12T12:00:44Z","reference_number":"EMADOC-1700519818-2421502","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyanocobalamin-diclofenac-pyridoxine-thiamine-list-nationally-authorised-medicinal-products-psusa-00001041-202501_en.pdf"},
    {"id":"70070","name":"Acetylsalicylic acid / bisoprolol : List of nationally authorised medicinal products - PSUSA/00010287/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-11T17:52:24Z","last_updated_date":"2025-09-11T17:52:24Z","reference_number":"EMADOC-1700519818-2428564","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetylsalicylic-acid-bisoprolol-list-nationally-authorised-medicinal-products-psusa-00010287-202411_en.pdf"},
    {"id":"70069","name":"Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-11T17:47:28Z","last_updated_date":"2025-09-11T17:47:28Z","reference_number":"EMADOC-1700519818-2431167","document_url":"https://www.ema.europa.eu/en/documents/psusa/botulinum-toxin-haemagglutinin-complex-list-nationally-authorised-medicinal-products-psusa-00000427-202412_en.pdf"},
    {"id":"70043","name":"Myristalkonium, benzalkonium (vaginal use only): List of nationally authorised medicinal products - PSUSA/00010987/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T11:35:16Z","last_updated_date":"2025-09-10T11:35:16Z","reference_number":"EMADOC-1700519818-2428244","document_url":"https://www.ema.europa.eu/en/documents/psusa/myristalkonium-benzalkonium-vaginal-use-only-list-nationally-authorised-medicinal-products-psusa-00010987-202501_en.pdf"},
    {"id":"70042","name":"Flunitrazepam: List of nationally authorised medicinal products - PSUSA/00001418/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T11:31:21Z","last_updated_date":"2025-09-10T11:31:21Z","reference_number":"EMADOC-1700519818-2424614","document_url":"https://www.ema.europa.eu/en/documents/psusa/flunitrazepam-list-nationally-authorised-medicinal-products-psusa-00001418-202501_en.pdf"},
    {"id":"70035","name":"Cefotaxime : List of nationally authorised medicinal products - PSUSA/00000599/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T10:14:27Z","last_updated_date":"2025-09-10T10:14:27Z","reference_number":"EMADOC-1700519818-2422541","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefotaxime-list-nationally-authorised-medicinal-products-psusa-00000599-202412_en.pdf"},
    {"id":"70036","name":"Typhoid vaccine (live, attenuated): List of nationally authorised medicinal products - PSUSA/00003067/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T10:20:51Z","last_updated_date":"2025-09-10T10:20:51Z","reference_number":"EMADOC-1700519818-2422542","document_url":"https://www.ema.europa.eu/en/documents/psusa/typhoid-vaccine-live-attenuated-list-nationally-authorised-medicinal-products-psusa-00003067-202412_en.pdf"},
    {"id":"70037","name":"Varicella-zoster immunoglobuline: List of nationally authorised medicinal products - PSUSA/00010266/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T10:27:25Z","last_updated_date":"2025-09-10T10:27:25Z","reference_number":"EMADOC-1700519818-2422545","document_url":"https://www.ema.europa.eu/en/documents/psusa/varicella-zoster-immunoglobuline-list-nationally-authorised-medicinal-products-psusa-00010266-202412_en.pdf"},
    {"id":"70038","name":"Human alfa1-proteinase inhibitor (apart from the centrally authorised product) : List of nationally authorised medicinal products - PSUSA/00000108/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T10:34:22Z","last_updated_date":"2025-09-10T10:34:22Z","reference_number":"EMADOC-1700519818-2425606","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-alfa1-proteinase-inhibitor-apart-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa-00000108-202412_en.pdf"},
    {"id":"70039","name":"Hydromorphone: List of nationally authorised medicinal products - PSUSA/00001686/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-10T10:45:54Z","last_updated_date":"2025-09-10T10:45:54Z","reference_number":"EMADOC-1700519818-2424948","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydromorphone-list-nationally-authorised-medicinal-products-psusa-00001686-202411_en.pdf"},
    {"id":"70029","name":"Nitric oxide : List of nationally authorised medicinal products - PSUSA/00002172/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-09T16:05:50Z","last_updated_date":"2025-09-09T16:05:50Z","reference_number":"EMADOC-1700519818-2422178","document_url":"https://www.ema.europa.eu/en/documents/psusa/nitric-oxide-list-nationally-authorised-medicinal-products-psusa-00002172-202412_en.pdf"},
    {"id":"70025","name":"amino acid combinations / glucose / triglyceride combinations : List of nationally authorised medicinal products - PSUSA/00010190/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-09T15:38:24Z","last_updated_date":"2025-09-09T15:38:24Z","reference_number":"EMADOC-1700519818-2421851","document_url":"https://www.ema.europa.eu/en/documents/psusa/amino-acid-combinations-glucose-triglyceride-combinations-list-nationally-authorised-medicinal-products-psusa-00010190-202412_en.pdf"},
    {"id":"70009","name":"Phenylephrine (ophthalmic formulations) : List of nationally authorised medicinal products - PSUSA/00010402/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-09T09:48:07Z","last_updated_date":"2025-09-09T09:48:07Z","reference_number":"EMADOC-1700519818-2418782","document_url":"https://www.ema.europa.eu/en/documents/psusa/phenylephrine-ophthalmic-formulations-list-nationally-authorised-medicinal-products-psusa-00010402-202501_en.pdf"},
    {"id":"70007","name":"Metamizole sodium / triacetonamine tosilate : List of nationally authorised medicinal products - PSUSA/00001999/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-09T09:45:00Z","last_updated_date":"2025-09-09T09:45:00Z","reference_number":"EMADOC-1700519818-2421622","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-sodium-triacetonamine-tosilate-list-nationally-authorised-medicinal-products-psusa-00001999-202501_en.pdf"},
    {"id":"69994","name":"Lidocaine / Phenazone : List of nationally authorised medicinal products - PSUSA/00002359/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-08T14:47:29Z","last_updated_date":"2025-09-08T14:47:29Z","reference_number":"EMADOC-1700519818-2421129","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-phenazone-list-nationally-authorised-medicinal-products-psusa-00002359-202501_en.pdf"},
    {"id":"69991","name":"Tapentadol : List of nationally authorised medicinal products - PSUSA/00002849/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-08T11:40:46Z","last_updated_date":"2025-09-08T11:40:46Z","reference_number":"EMADOC-1700519818-2419828","document_url":"https://www.ema.europa.eu/en/documents/psusa/tapentadol-list-nationally-authorised-medicinal-products-psusa-00002849-202411_en.pdf"},
    {"id":"69990","name":"bendamustine hydrochloride : List of nationally authorised medicinal products - PSUSA/00003162/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-08T10:25:23Z","last_updated_date":"2025-09-08T10:25:23Z","reference_number":"EMADOC-1700519818-2419189","document_url":"https://www.ema.europa.eu/en/documents/psusa/bendamustine-hydrochloride-list-nationally-authorised-medicinal-products-psusa-00003162-202501_en.pdf"},
    {"id":"69956","name":"Roxithromycin : List of nationally authorised medicinal products - PSUSA/00002669/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-05T08:33:15Z","last_updated_date":"2025-09-05T08:33:15Z","reference_number":"EMADOC-1700519818-2418834","document_url":"https://www.ema.europa.eu/en/documents/psusa/roxithromycin-list-nationally-authorised-medicinal-products-psusa-00002669-202412_en.pdf"},
    {"id":"69955","name":"Pirenoxine : List of nationally authorised medicinal products - PSUSA/00002431/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-04T15:26:54Z","last_updated_date":"2025-09-04T15:26:54Z","reference_number":"EMADOC-1700519818-2418120","document_url":"https://www.ema.europa.eu/en/documents/psusa/pirenoxine-list-nationally-authorised-medicinal-products-psusa-00002431-202501_en.pdf"},
    {"id":"69954","name":"Tizanidine : List of nationally authorised medicinal products - PSUSA/00002977/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-04T15:15:00Z","last_updated_date":"2025-09-04T15:15:00Z","reference_number":"EMADOC-1700519818-2418014","document_url":"https://www.ema.europa.eu/en/documents/psusa/tizanidine-list-nationally-authorised-medicinal-products-psusa-00002977-202412_en.pdf"},
    {"id":"69953","name":"Anthrax vaccine : List of nationally authorised medicinal products - PSUSA/00010771/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-04T15:12:05Z","last_updated_date":"2025-09-04T15:12:05Z","reference_number":"EMADOC-1700519818-2417859","document_url":"https://www.ema.europa.eu/en/documents/psusa/anthrax-vaccine-list-nationally-authorised-medicinal-products-psusa-00010771-202412_en.pdf"},
    {"id":"69950","name":"Alitretinoin (oral use) : List of nationally authorised medicinal products - PSUSA/00010710/202501","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-04T13:03:15Z","last_updated_date":"2025-09-04T13:03:15Z","reference_number":"EMADOC-1700519818-2417234","document_url":"https://www.ema.europa.eu/en/documents/psusa/alitretinoin-oral-use-list-nationally-authorised-medicinal-products-psusa-00010710-202501_en.pdf"},
    {"id":"69943","name":"Nicotine : List of nationally authorised medicinal products - PSUSA/00002153/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-09-03T14:38:53Z","last_updated_date":"2025-09-03T14:38:53Z","reference_number":"EMADOC-1700519818-2411267","document_url":"https://www.ema.europa.eu/en/documents/psusa/nicotine-list-nationally-authorised-medicinal-products-psusa-00002153-202412_en.pdf"},
    {"id":"69796","name":"Domperidone : List of nationally authorised medicinal products - PSUSA/00002024/202410 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-20T14:38:12Z","last_updated_date":"2025-08-20T14:38:12Z","reference_number":"EMADOC-1700519818-2318129","document_url":"https://www.ema.europa.eu/en/documents/psusa/domperidone-list-nationally-authorised-medicinal-products-psusa-00002024-202410_en.pdf"},
    {"id":"69733","name":"Isoniazid : List of nationally authorised medicinal products - PSUSA/00001789/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-13T17:58:01Z","last_updated_date":"2025-08-13T17:58:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/isoniazid-list-nationally-authorised-medicinal-products-psusa-00001789-202411_en.pdf"},
    {"id":"69700","name":"Miconazole, hydrocortisone / miconazole nitrate, miconazole nitrate / zinc oxide: List of nationally authorised medicinal products - PSUSA/00002052/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-12T15:13:57Z","last_updated_date":"2025-08-12T15:13:57Z","reference_number":"EMADOC-1700519818-2354019","document_url":"https://www.ema.europa.eu/en/documents/psusa/miconazole-hydrocortisone-miconazole-nitrate-miconazole-nitrate-zinc-oxide-list-nationally-authorised-medicinal-products-psusa-00002052-202410_en.pdf"},
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    {"id":"69648","name":"Methylphenidate : List of nationally authorised medicinal products - PSUSA/00002024/202410 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-05T08:30:49Z","last_updated_date":"2025-08-05T08:30:49Z","reference_number":"EMADOC-1700519818-2340477","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylphenidate-list-nationally-authorised-medicinal-products-psusa-00002024-202410_en.pdf"},
    {"id":"69646","name":"Dexketoprofen : List of nationally authorised medicinal products - PSUSA/00000997/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-05T08:15:30Z","last_updated_date":"2025-08-05T08:15:30Z","reference_number":"EMADOC-1700519818-2340229","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexketoprofen-list-nationally-authorised-medicinal-products-psusa-00000997-202410_en.pdf"},
    {"id":"69634","name":"Clotrimazole / hydrocortisone : List of nationally authorised medicinal products - PSUSA/00000831/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-01T16:53:33Z","last_updated_date":"2025-08-01T16:53:33Z","reference_number":"EMADOC-1700519818-2335312","document_url":"https://www.ema.europa.eu/en/documents/psusa/clotrimazole-hydrocortisone-list-nationally-authorised-medicinal-products-psusa-00000831-202411_en.pdf"},
    {"id":"69633","name":"Clotrimazole / dexamethasone : List of nationally authorised medicinal products - PSUSA/00000830/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-08-01T16:49:56Z","last_updated_date":"2025-08-01T16:49:56Z","reference_number":"EMADOC-1700519818-2335275","document_url":"https://www.ema.europa.eu/en/documents/psusa/clotrimazole-dexamethasone-list-nationally-authorised-medicinal-products-psusa-00000830-202411_en.pdf"},
    {"id":"69597","name":"Clotrimazole / metronidazole : List of nationally authorised medicinal products - PSUSA/00000832/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-31T15:00:33Z","last_updated_date":"2025-07-31T15:00:33Z","reference_number":"EMADOC-1700519818-2331291","document_url":"https://www.ema.europa.eu/en/documents/psusa/clotrimazole-metronidazole-list-nationally-authorised-medicinal-products-psusa-00000832-202411_en.pdf"},
    {"id":"69558","name":"Benzydamine : List of nationally authorised medicinal products - PSUSA/00000375/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-29T10:11:05Z","last_updated_date":"2025-07-29T10:11:05Z","reference_number":"EMADOC-1700519818-2305404","document_url":"https://www.ema.europa.eu/en/documents/psusa/benzydamine-list-nationally-authorised-medicinal-products-psusa-00000375-202410_en.pdf"},
    {"id":"69557","name":"Lornoxicam : List of nationally authorised medicinal products - PSUSA/00001911/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-29T10:06:44Z","last_updated_date":"2025-07-29T10:06:44Z","reference_number":"EMADOC-1700519818-2315708","document_url":"https://www.ema.europa.eu/en/documents/psusa/lornoxicam-list-nationally-authorised-medicinal-products-psusa-00001911-202412_en.pdf"},
    {"id":"69346","name":"Neomycin sulfate / nystatin / polymyxin b sulfate : List of nationally authorised medicinal products - PSUSA/00002139/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T11:57:05Z","last_updated_date":"2025-07-17T11:57:05Z","reference_number":"EMADOC-1700519818-2281239","document_url":"https://www.ema.europa.eu/en/documents/psusa/neomycin-sulfate-nystatin-polymyxin-b-sulfate-list-nationally-authorised-medicinal-products-psusa-00002139-202411_en.pdf"},
    {"id":"69344","name":"Metoclopramide : List of nationally authorised medicinal products - PSUSA/00002036/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T11:43:57Z","last_updated_date":"2025-07-17T11:43:57Z","reference_number":"EMADOC-1700519818-2285119","document_url":"https://www.ema.europa.eu/en/documents/psusa/metoclopramide-list-nationally-authorised-medicinal-products-psusa-00002036-202411_en.pdf"},
    {"id":"69343","name":"Methocarbamol : List of nationally authorised medicinal products - PSUSA/00002011/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T11:39:42Z","last_updated_date":"2025-07-17T11:39:42Z","reference_number":"EMADOC-1700519818-2282541","document_url":"https://www.ema.europa.eu/en/documents/psusa/methocarbamol-list-nationally-authorised-medicinal-products-psusa-00002011-202412_en.pdf"},
    {"id":"69260","name":"Paracetamol / pseudoephedrine hydrochloride / triprolidine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010270/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-17T11:22:35Z","last_updated_date":"2025-07-17T11:22:35Z","reference_number":"EMADOC-1700519818-2295885","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-pseudoephedrine-hydrochloride-triprolidine-hydrochloride-list-nationally-authorised-medicinal-products-psusa-00010270-202411_en.pdf"},
    {"id":"69287","name":"Acetylsalicylic acid / caffeine / paracetamol : List of nationally authorised medicinal products - PSUSA/00002291/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-15T11:38:17Z","last_updated_date":"2025-07-15T11:38:17Z","reference_number":"EMADOC-1700519818-2288925","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetylsalicylic-acid-caffeine-paracetamol-list-nationally-authorised-medicinal-products-psusa-00002291-202412_en.pdf"},
    {"id":"69286","name":"Natamycin : List of nationally authorised medicinal products - PSUSA/00003179/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-15T11:34:43Z","last_updated_date":"2025-07-15T11:34:43Z","reference_number":"EMADOC-1700519818-2287409","document_url":"https://www.ema.europa.eu/en/documents/psusa/natamycin-list-nationally-authorised-medicinal-products-psusa-00003179-202411_en.pdf"},
    {"id":"69285","name":"Metamizole sodium / pitofenone hydrochloride : List of nationally authorised medicinal products - PSUSA/00002443/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-15T11:25:21Z","last_updated_date":"2025-07-15T11:25:21Z","reference_number":"EMADOC-1700519818-2286811","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-sodium-pitofenone-hydrochloride-list-nationally-authorised-medicinal-products-psusa-00002443-202412_en.pdf"},
    {"id":"69284","name":"Ceftobiprole : List of nationally authorised medicinal products - PSUSA/00010734/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-15T11:21:03Z","last_updated_date":"2025-07-15T11:21:03Z","reference_number":"EMADOC-1700519818-2286838","document_url":"https://www.ema.europa.eu/en/documents/psusa/ceftobiprole-list-nationally-authorised-medicinal-products-psusa-00010734-202411_en.pdf"},
    {"id":"69279","name":"Antazoline / tetryzoline : List of nationally authorised medicinal products - PSUSA/00000219/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-15T09:59:38Z","last_updated_date":"2025-07-15T09:59:38Z","reference_number":"EMADOC-1700519818-2286976","document_url":"https://www.ema.europa.eu/en/documents/psusa/antazoline-tetryzoline-list-nationally-authorised-medicinal-products-psusa-00000219-202412_en.pdf"},
    {"id":"69277","name":"Dextromethorphan hydrobromide / paracetamol / promethazine hydrochloride : List of nationally authorised medicinal products - PSUSA/00002300/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-15T09:41:18Z","last_updated_date":"2025-07-15T09:41:18Z","reference_number":"EMADOC-1700519818-2286842","document_url":"https://www.ema.europa.eu/en/documents/psusa/dextromethorphan-hydrobromide-paracetamol-promethazine-hydrochloride-list-nationally-authorised-medicinal-products-psusa-00002300-202411_en.pdf"},
    {"id":"69261","name":"Urea hydrogen peroxide : List of nationally authorised medicinal products - PSUSA/00009326/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-14T11:27:21Z","last_updated_date":"2025-07-14T11:27:21Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/urea-hydrogen-peroxide-list-nationally-authorised-medicinal-products-psusa-00009326-202411_en.pdf"},
    {"id":"69259","name":"Chlorphenamine / dextromethorphan hydrobromide/ paracetamol : List of nationally authorised medicinal products - PSUSA/00000699/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-14T11:18:07Z","last_updated_date":"2025-07-14T11:18:07Z","reference_number":"EMADOC-1700519818-2285455","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorphenamine-dextromethorphan-hydrobromide-paracetamol-list-nationally-authorised-medicinal-products-psusa-00000699-202411_en.pdf"},
    {"id":"69258","name":"Dextromethorphan / paracetamol / phenylephrine : List of nationally authorised medicinal products - PSUSA/00009247/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-14T11:14:23Z","last_updated_date":"2025-07-14T11:14:23Z","reference_number":"EMADOC-1700519818-2281620","document_url":"https://www.ema.europa.eu/en/documents/psusa/dextromethorphan-paracetamol-phenylephrine-list-nationally-authorised-medicinal-products-psusa-00009247-202411_en.pdf"},
    {"id":"69243","name":"Dextromethorphan hydrobromide / diphenhydramine hydrochloride / levomenthol : List of nationally authorised medicinal products - PSUSA/00001013/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-11T13:31:57Z","last_updated_date":"2025-07-11T13:31:57Z","reference_number":"EMADOC-1700519818-2283017","document_url":"https://www.ema.europa.eu/en/documents/psusa/dextromethorphan-hydrobromide-diphenhydramine-hydrochloride-levomenthol-list-nationally-authorised-medicinal-products-psusa-00001013-202411_en.pdf"},
    {"id":"69242","name":"Mexazolam : List of nationally authorised medicinal products - PSUSA/00002047/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-11T13:09:03Z","last_updated_date":"2025-07-11T13:09:03Z","reference_number":"EMADOC-1700519818-2282864","document_url":"https://www.ema.europa.eu/en/documents/psusa/mexazolam-list-nationally-authorised-medicinal-products-psusa-00002047-202412_en.pdf"},
    {"id":"69238","name":"Oxygen : List of nationally authorised medicinal products - PSUSA/00002257/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-11T10:39:57Z","last_updated_date":"2025-07-11T10:39:57Z","reference_number":"EMADOC-1700519818-2281883","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxygen-list-nationally-authorised-medicinal-products-psusa-00002257-202412_en.pdf"},
    {"id":"69231","name":"Dihydroxyaluminum sodium carbonate, dihydroxyaluminum sodium carbonate / dimeticone : List of nationally authorised medicinal products - PSUSA/00001098/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-10T14:41:02Z","last_updated_date":"2025-07-10T14:41:02Z","reference_number":"EMADOC-1700519818-2276867","document_url":"https://www.ema.europa.eu/en/documents/psusa/dihydroxyaluminum-sodium-carbonate-dihydroxyaluminum-sodium-carbonate-dimeticone-list-nationally-authorised-medicinal-products-psusa-00001098-202411_en.pdf"},
    {"id":"69230","name":"Cyanocobalamin / folic acid / pyridoxine : List of nationally authorised medicinal products - PSUSA/00000893/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-10T14:36:19Z","last_updated_date":"2025-07-10T14:36:19Z","reference_number":"EMADOC-1700519818-2275788","document_url":"https://www.ema.europa.eu/en/documents/psusa/cyanocobalamin-folic-acid-pyridoxine-list-nationally-authorised-medicinal-products-psusa-00000893-202411_en.pdf"},
    {"id":"69229","name":"Acrivastine, acrivastine / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00000054/202412","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-10T14:32:43Z","last_updated_date":"2025-07-10T14:32:43Z","reference_number":"EMADOC-1700519818-2275709","document_url":"https://www.ema.europa.eu/en/documents/psusa/acrivastine-acrivastine-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa-00000054-202412_en.pdf"},
    {"id":"69228","name":"Diphenhydramine / paracetamol : List of nationally authorised medicinal products - PSUSA/00001110/202411","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-10T14:27:28Z","last_updated_date":"2025-07-10T14:27:28Z","reference_number":"EMADOC-1700519818-2275617","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphenhydramine-paracetamol-list-nationally-authorised-medicinal-products-psusa-00001110-202411_en.pdf"},
    {"id":"69161","name":"Sumatriptan, naproxen / sumatriptan : List of nationally authorised medicinal products - PSUSA/00002832/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-08T12:50:47Z","last_updated_date":"2025-07-08T12:50:47Z","reference_number":"EMA/178301/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/sumatriptan-naproxen-sumatriptan-list-nationally-authorised-medicinal-products-psusa-00002832-202409_en.pdf"},
    {"id":"69148","name":"Diclofenac (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00001048/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-07-07T15:45:46Z","last_updated_date":"2025-07-07T15:45:46Z","reference_number":"EMA/139612/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/diclofenac-systemic-formulations-list-nationally-authorised-medicinal-products-psusa-00001048-202409_en.pdf"},
    {"id":"68738","name":"Etonogestrel : List of nationally authorised medicinal products - PSUSA/00001331/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-13T12:46:42Z","last_updated_date":"2025-06-13T12:46:42Z","reference_number":"EMA/201683/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/etonogestrel-list-nationally-authorised-medicinal-products-psusa-00001331-202409_en.pdf"},
    {"id":"68568","name":"Hydrocortisone (systemic formulations) :  List of nationally authorised medicinal products - PSUSA/00010855/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-04T11:03:14Z","last_updated_date":"2025-06-04T11:03:14Z","reference_number":"EMA/189473/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrocortisone-systemic-formulations-list-nationally-authorised-medicinal-products-psusa-00010855-202408_en.pdf"},
    {"id":"68693","name":"Meropenem : List of nationally authorised medicinal products - PSUSA/00001989/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-11T14:02:17Z","last_updated_date":"2025-06-11T14:02:17Z","reference_number":"EMA/56732/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/meropenem-list-nationally-authorised-medicinal-products-psusa-00001989-202408_en.pdf"},
    {"id":"68690","name":"Fluticasone / salmeterol (for nationally authorised products) : List of nationally authorised medicinal products - PSUSA/00001455/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-11T11:32:22Z","last_updated_date":"2025-06-11T11:32:22Z","reference_number":"EMADOC-1700519818-2206399","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluticasone-salmeterol-nationally-authorised-products-list-nationally-authorised-medicinal-products-psusa-00001455-202410_en.pdf"},
    {"id":"68643","name":"Ascorbic acid / magnesium aspartate / leucine L / lysine L / phenylalanine L / valine L : List of nationally authorised medicinal products - PSUSA/00010988/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-10T13:45:07Z","last_updated_date":"2025-06-10T13:45:07Z","reference_number":"EMADOC-1700519818-2203817","document_url":"https://www.ema.europa.eu/en/documents/psusa/ascorbic-acid-magnesium-aspartate-leucine-l-lysine-l-phenylalanine-l-valine-l-list-nationally-authorised-medicinal-products-psusa-00010988-202410_en.pdf"},
    {"id":"68596","name":"Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-06T09:21:22Z","last_updated_date":"2025-06-06T09:21:22Z","reference_number":"EMA/193200/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/letrozole-list-nationally-authorised-medicinal-products-psusa-00001842-202410_en.pdf"},
    {"id":"68585","name":"Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202410","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-05T14:34:32Z","last_updated_date":"2025-06-05T14:34:32Z","reference_number":"EMADOC-1700519818-2191524","document_url":"https://www.ema.europa.eu/en/documents/psusa/acitretin-list-nationally-authorised-medicinal-products-psusa-00000051-202410_en.pdf"},
    {"id":"68507","name":"Oxcarbazepine : List of nationally authorised medicinal products - PSUSA/00002235/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-06-02T09:19:50Z","last_updated_date":"2025-06-02T09:19:50Z","reference_number":"EMA/185109/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxcarbazepine-list-nationally-authorised-medicinal-products-psusa-00002235-202408_en.pdf"},
    {"id":"68482","name":"Chlorocresol / chlorhexidine / hexamidine : List of nationally authorised medicinal products - PSUSA/00001603/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-28T09:43:28Z","last_updated_date":"2025-05-28T09:43:28Z","reference_number":"EMA/177186/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorocresol-chlorhexidine-hexamidine-list-nationally-authorised-medicinal-products-psusa-00001603-202408_en.pdf"},
    {"id":"68480","name":"Anastrozole : List of nationally authorised medicinal products - PSUSA/00000210/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-28T09:32:50Z","last_updated_date":"2025-05-28T09:32:50Z","reference_number":"EMA/77052/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/anastrozole-list-nationally-authorised-medicinal-products-psusa-00000210-202408_en.pdf"},
    {"id":"68469","name":"Phloroglucinol, phloroglucinol / trimethylphloroglucinol : List of nationally authorised medicinal products - PSUSA/00010355/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-27T13:57:15Z","last_updated_date":"2025-05-27T13:57:15Z","reference_number":"EMA/176770/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/phloroglucinol-phloroglucinol-trimethylphloroglucinol-list-nationally-authorised-medicinal-products-psusa-00010355-202409_en.pdf"},
    {"id":"68359","name":"Pramiracetam : List of nationally authorised medicinal products - PSUSA/00002492/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-19T17:24:36Z","last_updated_date":"2025-05-19T17:24:36Z","reference_number":"EMA/169859/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/pramiracetam-list-nationally-authorised-medicinal-products-psusa-00002492-202409_en.pdf"},
    {"id":"68253","name":"Hexaminolevulinate hydrochloride : List of nationally authorised medicinal products - PSUSA/00001606/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-13T12:13:45Z","last_updated_date":"2025-05-13T12:13:45Z","reference_number":"EMA/PRAC/9837/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/hexaminolevulinate-hydrochloride-list-nationally-authorised-medicinal-products-psusa-00001606-202409_en.pdf"},
    {"id":"68252","name":"Carmustine (implant) : List of nationally authorised medicinal products - PSUSA/00010348/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-13T12:09:56Z","last_updated_date":"2025-05-13T12:09:56Z","reference_number":"EMA/9840/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/carmustine-implant-list-nationally-authorised-medicinal-products-psusa-00010348-202409_en.pdf"},
    {"id":"68231","name":"Naphazoline, naphazoline, zinc sulphate : List of nationally authorised medicinal products - PSUSA/00010571/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T15:01:35Z","last_updated_date":"2025-05-12T15:01:35Z","reference_number":"EMA/85820/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/naphazoline-naphazoline-zinc-sulphate-list-nationally-authorised-medicinal-products-psusa-00010571-202407_en.pdf"},
    {"id":"68229","name":"Zidovudine : EPAR - List of nationally authorised medicinal products - PSUSA/00003143/202409","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-12T14:54:59Z","last_updated_date":"2025-05-12T14:54:59Z","reference_number":"EMA/148474/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/zidovudine-epar-list-nationally-authorised-medicinal-products-psusa-00003143-202409_en.pdf"},
    {"id":"68143","name":"Magnesium sulfate / sodium sulfate / potassium sulfate : List of nationally authorised medicinal products - PSUSA/00010239/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-07T12:38:40Z","last_updated_date":"2025-05-07T12:38:40Z","reference_number":"EMA/83293/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/magnesium-sulfate-sodium-sulfate-potassium-sulfate-list-nationally-authorised-medicinal-products-psusa-00010239-202408_en.pdf"},
    {"id":"68115","name":"Everolimus : List of nationally authorised medicinal products - PSUSA/00010269/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-06T14:46:43Z","last_updated_date":"2025-05-06T14:46:43Z","reference_number":"EMA/154422/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/everolimus-list-nationally-authorised-medicinal-products-psusa-00010269-202407_en.pdf"},
    {"id":"68113","name":"Cinchocaine hydrochloride / hydrocortisone : List of nationally authorised medicinal products - PSUSA/00000761/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-06T12:37:15Z","last_updated_date":"2025-05-06T12:37:15Z","reference_number":"EMA/154287/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/cinchocaine-hydrochloride-hydrocortisone-list-nationally-authorised-medicinal-products-psusa-00000761-202408_en.pdf"},
    {"id":"68103","name":"Thiocolchicoside, paracetamol / thiocolchicoside : List of nationally authorised medicinal products - PSUSA/00010464/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-05-06T09:17:27Z","last_updated_date":"2025-05-06T09:17:27Z","reference_number":"EMA/153049/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/thiocolchicoside-paracetamol-thiocolchicoside-list-nationally-authorised-medicinal-products-psusa-00010464-202407_en.pdf"},
    {"id":"67871","name":"Acenocoumarol : List of nationally authorised medicinal products - PSUSA/00000027/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-16T12:12:12Z","last_updated_date":"2025-04-16T12:12:12Z","reference_number":"EMA/134239/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/acenocoumarol-list-nationally-authorised-medicinal-products-psusa-00000027-202407_en.pdf"},
    {"id":"67854","name":"Thallium [201TL] : List of nationally authorised medicinal products - PSUSA/00002920/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-15T14:10:47Z","last_updated_date":"2025-04-15T14:10:47Z","reference_number":"EMA/PRAC/583151/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/thallium-201tl-list-nationally-authorised-medicinal-products-psusa-00002920-202408_en.pdf"},
    {"id":"67835","name":"Busulfan : List of nationally authorised medicinal products - PSUSA/00000464/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-15T09:15:14Z","last_updated_date":"2025-04-15T09:15:14Z","reference_number":"EMA/130846/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/busulfan-list-nationally-authorised-medicinal-products-psusa-00000464-202407_en.pdf"},
    {"id":"67755","name":"Ciclesonide : List of nationally authorised medicinal products - PSUSA/00000742/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-11T13:30:09Z","last_updated_date":"2025-04-11T13:30:09Z","reference_number":"EMA/128781/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciclesonide-list-nationally-authorised-medicinal-products-psusa-00000742-202408_en.pdf"},
    {"id":"67741","name":"Hydrocortisone (all formulations apart from systemic use) : List of nationally authorised medicinal products - PSUSA/00010856/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-10T16:12:45Z","last_updated_date":"2025-04-10T16:12:45Z","reference_number":"EMA/111258/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrocortisone-all-formulations-apart-systemic-use-list-nationally-authorised-medicinal-products-psusa-00010856-202408_en.pdf"},
    {"id":"67630","name":"Tiagabine : List of nationally authorised medicinal products - PSUSA/00002942/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-04-04T10:47:10Z","last_updated_date":"2025-04-04T10:47:10Z","reference_number":"EMA/85817/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/tiagabine-list-nationally-authorised-medicinal-products-psusa-00002942-202406_en.pdf"},
    {"id":"67351","name":"Budesonide / salmeterol : List of nationally authorised medicinal products - PSUSA/00010511/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-19T15:26:32Z","last_updated_date":"2025-03-19T15:26:32Z","reference_number":"EMA/99800/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/budesonide-salmeterol-list-nationally-authorised-medicinal-products-psusa-00010511-202407_en.pdf"},
    {"id":"67350","name":"Tiapride : List of nationally authorised medicinal products - PSUSA/00002944/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-19T15:04:29Z","last_updated_date":"2025-03-19T15:04:29Z","reference_number":"EMA/94547/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/tiapride-list-nationally-authorised-medicinal-products-psusa-00002944-202407_en.pdf"},
    {"id":"67349","name":"Montelukast : List of nationally authorised medicinal products - PSUSA/00002087/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-19T14:23:32Z","last_updated_date":"2025-03-19T14:23:32Z","reference_number":"EMA/96425/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/montelukast-list-nationally-authorised-medicinal-products-psusa-00002087-202407_en.pdf"},
    {"id":"67348","name":"Neomycin / triamcinolone : List of nationally authorised medicinal products - PSUSA/00000081/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-19T13:26:17Z","last_updated_date":"2025-03-19T13:26:17Z","reference_number":"EMA/39071/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/neomycin-triamcinolone-list-nationally-authorised-medicinal-products-psusa-00000081-202408_en.pdf"},
    {"id":"67270","name":"Bibrocathol : List of nationally authorised medicinal products - PSUSA/00000406/202408","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-14T10:23:03Z","last_updated_date":"2025-03-14T10:23:03Z","reference_number":"EMA/66753/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/bibrocathol-list-nationally-authorised-medicinal-products-psusa-00000406-202408_en.pdf"},
    {"id":"67258","name":"Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide : List of nationally authorised medicinal products - PSUSA/00010390/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-13T15:25:57Z","last_updated_date":"2025-03-13T15:25:57Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/lidocaine-hydrochloride-phenylephrine-hydrochloride-tropicamide-list-nationally-authorised-medicinal-products-psusa-00010390-202407_en.pdf"},
    {"id":"67257","name":"Lactobacillus all subspecies and combinations of subspecies : List of nationally authorised medicinal products - PSUSA/00010598/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-13T15:21:51Z","last_updated_date":"2025-03-13T15:21:51Z","reference_number":"EMA/PRAC/94282/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/lactobacillus-all-subspecies-combinations-subspecies-list-nationally-authorised-medicinal-products-psusa-00010598-202407_en.pdf"},
    {"id":"67244","name":"Oxycodone hydrochloride / paracetamol : List of nationally authorised medicinal products - PSUSA/00002256/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-13T10:58:17Z","last_updated_date":"2025-03-13T10:58:17Z","reference_number":"EMA/92621/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxycodone-hydrochloride-paracetamol-list-nationally-authorised-medicinal-products-psusa-00002256-202407_en.pdf"},
    {"id":"67151","name":"Bismuth subcitrate potassium / metronidazole / tetracycline : List of nationally authorised medicinal products - PSUSA/00010199/202405","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-07T15:01:23Z","last_updated_date":"2025-03-07T15:01:23Z","reference_number":"EMA/54617/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/bismuth-subcitrate-potassium-metronidazole-tetracycline-list-nationally-authorised-medicinal-products-psusa-00010199-202405_en.pdf"},
    {"id":"67143","name":"Iobitridol : List of nationally authorised medicinal products - PSUSA/00001761/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-07T13:42:47Z","last_updated_date":"2025-03-07T13:42:47Z","reference_number":"EMA/440826/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/iobitridol-list-nationally-authorised-medicinal-products-psusa-00001761-202404_en.pdf"},
    {"id":"67141","name":"Aciclovir : List of nationally authorised medicinal products - PSUSA/00000048/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-07T13:34:48Z","last_updated_date":"2025-03-07T13:34:48Z","reference_number":"EMA/574822/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/aciclovir-list-nationally-authorised-medicinal-products-psusa-00000048-202406_en.pdf"},
    {"id":"67120","name":"Phenylpropanolamine : List of nationally authorised medicinal products - PSUSA/00010483/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-06T09:56:07Z","last_updated_date":"2025-03-06T09:56:07Z","reference_number":"EMA/82944/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/phenylpropanolamine-list-nationally-authorised-medicinal-products-psusa-00010483-202406_en.pdf"},
    {"id":"67080","name":"Tianeptine : List of nationally authorised medicinal products - PSUSA/00002943/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-03-03T14:53:08Z","last_updated_date":"2025-03-03T14:53:08Z","reference_number":"EMA/77513/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/tianeptine-list-nationally-authorised-medicinal-products-psusa-00002943-202406_en.pdf"},
    {"id":"66944","name":"Propranolol (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00010251/202406 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-25T13:23:25Z","last_updated_date":"2025-02-25T13:23:25Z","reference_number":"EMA/24132/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/propranolol-except-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa-00010251-202406_en.pdf"},
    {"id":"66880","name":"Brivudine : List of nationally authorised medicinal products - PSUSA/00000434/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-19T16:54:00Z","last_updated_date":"2025-02-19T16:54:00Z","reference_number":"EMA/62438/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/brivudine-list-nationally-authorised-medicinal-products-psusa-00000434-202407_en.pdf"},
    {"id":"66783","name":"Clebopride : List of nationally authorised medicinal products - PSUSA/00000789/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T13:52:43Z","last_updated_date":"2025-02-14T13:52:43Z","reference_number":"EMA/58840/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/clebopride-list-nationally-authorised-medicinal-products-psusa-00000789-202406_en.pdf"},
    {"id":"66781","name":"Dexchlorpheniramine : List of nationally authorised medicinal products - PSUSA/00000989/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T13:50:02Z","last_updated_date":"2025-02-14T13:50:02Z","reference_number":"EMA/58813/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexchlorpheniramine-list-nationally-authorised-medicinal-products-psusa-00000989-202406_en.pdf"},
    {"id":"66780","name":"Nilutamide : List of nationally authorised medicinal products - PSUSA/00002163/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-14T13:47:00Z","last_updated_date":"2025-02-14T13:47:00Z","reference_number":"EMA/487410/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/nilutamide-list-nationally-authorised-medicinal-products-psusa-00002163-202407_en.pdf"},
    {"id":"66754","name":"Human plasma proteins with no less than 95% albumin : List of nationally authorised medicinal product - PSUSA/00010605/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-13T16:32:33Z","last_updated_date":"2025-02-13T16:32:33Z","reference_number":"EMA/53721/2025EMA/53721/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-plasma-proteins-no-less-95-albumin-list-nationally-authorised-medicinal-product-psusa-00010605-202407_en.pdf"},
    {"id":"66749","name":"Nimesulide (systemic formulations) : List of nationally authorised medicinal products - PSUSA/00009236/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-13T15:55:34Z","last_updated_date":"2025-02-13T15:55:34Z","reference_number":"EMA/PRAC/46708/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/nimesulide-systemic-formulations-list-nationally-authorised-medicinal-products-psusa-00009236-202406_en.pdf"},
    {"id":"66748","name":"Benzalkonium chloride / ethyl alcohol, benzalkonium chloride / isopropyl alcohol : List of nationally authorised medicinal products - PSUSA/00000342/202407","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-13T15:49:47Z","last_updated_date":"2025-02-13T15:49:47Z","reference_number":"EMA/42086/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/benzalkonium-chloride-ethyl-alcohol-benzalkonium-chloride-isopropyl-alcohol-list-nationally-authorised-medicinal-products-psusa-00000342-202407_en.pdf"},
    {"id":"66613","name":"Oxaliplatin : List of nationally authorised medicinal products - PSUSA/00002229/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-05T15:08:20Z","last_updated_date":"2025-02-05T15:08:20Z","reference_number":"EMA/360417/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxaliplatin-list-nationally-authorised-medicinal-products-psusa-00002229-202404_en.pdf"},
    {"id":"66573","name":"Biclotymol : List of nationally authorised medicinal products - PSUSA/00000408/202405","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-02-03T13:22:00Z","last_updated_date":"2025-02-03T13:22:00Z","reference_number":"EMA/574832/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/biclotymol-list-nationally-authorised-medicinal-products-psusa-00000408-202405_en.pdf"},
    {"id":"66496","name":"Olodaterol / tiotropium : List of nationally authorised medicinal products - PSUSA/00010489/202405","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-29T09:19:06Z","last_updated_date":"2025-01-29T09:19:06Z","reference_number":"EMA/25572/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/olodaterol-tiotropium-list-nationally-authorised-medicinal-products-psusa-00010489-202405_en.pdf"},
    {"id":"66470","name":"Promethazine : List of nationally authorised medicinal products - PSUSA/00002545/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-27T14:58:42Z","last_updated_date":"2025-01-27T14:58:42Z","reference_number":"EMA/34446/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/promethazine-list-nationally-authorised-medicinal-products-psusa-00002545-202404_en.pdf"},
    {"id":"66436","name":"Nebivolol : List of nationally authorised medicinal products - PSUSA/00002129/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-23T17:01:07Z","last_updated_date":"2025-01-23T17:01:07Z","reference_number":"EMA/31166/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/nebivolol-list-nationally-authorised-medicinal-products-psusa-00002129-202403_en.pdf"},
    {"id":"66413","name":"Ambrosia Artemisiifolia (302) (sublingual use, products authorised via decentralised procedure) : List of nationally authorised medicinal products - PSUSA/00010693/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-22T13:10:34Z","last_updated_date":"2025-01-22T13:10:34Z","reference_number":"EMA/28467/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/ambrosia-artemisiifolia-302-sublingual-use-products-authorised-decentralised-procedure-list-nationally-authorised-medicinal-products-psusa-00010693-202404_en.pdf"},
    {"id":"66394","name":"Ranitidine : List of nationally authorised medicinal products - PSUSA/00002610/202405","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-21T12:15:07Z","last_updated_date":"2025-01-21T12:15:07Z","reference_number":"EMA/25527/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/ranitidine-list-nationally-authorised-medicinal-products-psusa-00002610-202405_en.pdf"},
    {"id":"66392","name":"Fentanyl (transdermal patches, solution for injection - nationally authorised product only) : List of nationally authorised medicinal products - PSUSA/00001370/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-21T12:05:47Z","last_updated_date":"2025-01-21T12:05:47Z","reference_number":"EMA/540656/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/fentanyl-transdermal-patches-solution-injection-nationally-authorised-product-only-list-nationally-authorised-medicinal-products-psusa-00001370-202404_en.pdf"},
    {"id":"66373","name":"Metyrapone : List of nationally authorised medicinal products - PSUSA/00002046/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-20T14:03:07Z","last_updated_date":"2025-01-20T14:03:07Z","reference_number":"EMA/24132/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/metyrapone-list-nationally-authorised-medicinal-products-psusa-00002046-202406_en.pdf"},
    {"id":"66349","name":"Metformin : List of nationally authorised medicinal products - PSUSA/00002001/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-17T12:36:54Z","last_updated_date":"2025-01-17T12:36:54Z","reference_number":"EMA/PRAC/540435/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/metformin-list-nationally-authorised-medicinal-products-psusa-00002001-202404_en.pdf"},
    {"id":"66343","name":"Tafluprost : List of nationally authorised medicinal products - PSUSA/00002843/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-17T10:36:52Z","last_updated_date":"2025-01-17T10:36:52Z","reference_number":"EMA/PRAC/21370/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/tafluprost-list-nationally-authorised-medicinal-products-psusa-00002843-202404_en.pdf"},
    {"id":"66335","name":"Yohimbine : List of nationally authorised medicinal products - PSUSA/00003136/202405","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-16T16:51:17Z","last_updated_date":"2025-01-16T16:51:17Z","reference_number":"EMA/362/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/yohimbine-list-nationally-authorised-medicinal-products-psusa-00003136-202405_en.pdf"},
    {"id":"66334","name":"Alginic acid / aluminium oxide hydrated / sodium hydrogen carbonate, alginic acid / aluminium hydroxide / calcium carbonate / sodium carbonate : List of nationally authorised medicinal products - PSUSA/00000123/202406","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-16T16:27:28Z","last_updated_date":"2025-01-16T16:27:28Z","reference_number":"EMA/369/2025","document_url":"https://www.ema.europa.eu/en/documents/psusa/alginic-acid-aluminium-oxide-hydrated-sodium-hydrogen-carbonate-alginic-acid-aluminium-hydroxide-calcium-carbonate-sodium-carbonate-list-nationally-authorised-medicinal-products-psusa-00000123-202406_en.pdf"},
    {"id":"66259","name":"Bilastine : List of nationally authorised medicinal products - PSUSA/00003163/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-07T15:46:34Z","last_updated_date":"2025-01-07T15:46:34Z","reference_number":"EMA/487378/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/bilastine-list-nationally-authorised-medicinal-products-psusa-00003163-202403_en.pdf"},
    {"id":"66249","name":"Chlorphenamine maleate / paracetamol : List of nationally authorised medicinal products - PSUSA/00000703/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-06T16:42:01Z","last_updated_date":"2025-01-06T16:42:01Z","reference_number":"EMA/598255/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlorphenamine-maleate-paracetamol-list-nationally-authorised-medicinal-products-psusa-00000703-202403_en.pdf"},
    {"id":"66242","name":"Lanthanum : List of nationally authorised medicinal products - PSUSA/00003175/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-06T14:37:17Z","last_updated_date":"2025-01-06T14:37:17Z","reference_number":"EMA/596073/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/lanthanum-list-nationally-authorised-medicinal-products-psusa-00003175-202403_en.pdf"},
    {"id":"66239","name":"Oxycodone : List of nationally authorised medicinal products - PSUSA/00002254/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2025-01-06T14:28:46Z","last_updated_date":"2025-01-06T14:28:46Z","reference_number":"EMA/596129/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxycodone-list-nationally-authorised-medicinal-products-psusa-00002254-202404_en.pdf"},
    {"id":"65937","name":"Ciprofloxacin / fluocinolone acetonide : List of nationally authorised medicinal products - PSUSA/00000772/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-12-04T10:22:30Z","last_updated_date":"2024-12-04T10:22:30Z","reference_number":"EMA/563900/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ciprofloxacin-fluocinolone-acetonide-list-nationally-authorised-medicinal-products-psusa-00000772-202404_en.pdf"},
    {"id":"65889","name":"Ofloxacin (topical use) : List of nationally authorised medicinal products - PSUSA/00002204/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-12-02T12:26:32Z","last_updated_date":"2024-12-02T12:26:32Z","reference_number":"EMA/459239/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ofloxacin-topical-use-list-nationally-authorised-medicinal-products-psusa-00002204-202404_en.pdf"},
    {"id":"65877","name":"Isotretinoin (oral formulations) : List of nationally authorised medicinal products - PSUSA/00010488/202405","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-28T16:52:16Z","last_updated_date":"2024-11-28T16:52:16Z","reference_number":"EMA/535406/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/isotretinoin-oral-formulations-list-nationally-authorised-medicinal-products-psusa-00010488-202405_en.pdf"},
    {"id":"65873","name":"Bupivacaine, bupivacaine / epinephrine : List of nationally authorised medicinal products - PSUSA/00010335/202404","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-28T15:22:03Z","last_updated_date":"2024-11-28T15:22:03Z","reference_number":"EMA/PRAC/539781/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/bupivacaine-bupivacaine-epinephrine-list-nationally-authorised-medicinal-products-psusa-00010335-202404_en.pdf"},
    {"id":"65760","name":"Mesalazine : List of nationally authorised medicinal products - PSUSA/00001990/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-22T11:22:54Z","last_updated_date":"2024-11-22T11:22:54Z","reference_number":"EMA/459995/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/mesalazine-list-nationally-authorised-medicinal-products-psusa-00001990-202402_en.pdf"},
    {"id":"65757","name":"Terazosin : List of nationally authorised medicinal products - PSUSA/00002895/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-22T11:01:22Z","last_updated_date":"2024-11-22T11:01:22Z","reference_number":"EMA/545639/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/terazosin-list-nationally-authorised-medicinal-products-psusa-00002895-202311_en.pdf"},
    {"id":"65755","name":"Zofenopril : List of nationally authorised medicinal products - PSUSA/00003147/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-22T10:54:34Z","last_updated_date":"2024-11-22T10:54:34Z","reference_number":"EMA/545639/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/zofenopril-list-nationally-authorised-medicinal-products-psusa-00003147-202401_en.pdf"},
    {"id":"65743","name":"Amiodarone : List of nationally authorised medicinal products - PSUSA/00000166/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-21T09:19:37Z","last_updated_date":"2024-11-21T09:19:37Z","reference_number":"EMA/CHMP/544052/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/amiodarone-list-nationally-authorised-medicinal-products-psusa-00000166-202312_en.pdf"},
    {"id":"65606","name":"Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack) : List of nationally authorised medicinal products - PSUSA/00010442/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-13T11:54:30Z","last_updated_date":"2024-11-13T11:54:30Z","reference_number":"EMA/390583/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/levonorgestrel-ethinylestradiol-ethinylestradiol-combination-pack-list-nationally-authorised-medicinal-products-psusa-00010442-202401_en.pdf"},
    {"id":"65562","name":"Zoledronic acid: List of nationally authorised medicinal products - PSUSA/00003149/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-07T13:50:40Z","last_updated_date":"2024-11-07T13:50:40Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/zoledronic-acid-list-nationally-authorised-medicinal-products-psusa-00003149-202308_en.pdf"},
    {"id":"65557","name":"Barnidipine : List of nationally authorised medicinal products - PSUSA/00000300/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-06T14:10:48Z","last_updated_date":"2024-11-06T14:10:48Z","reference_number":"EMA/515521/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/barnidipine-list-nationally-authorised-medicinal-products-psusa-00000300-202403_en.pdf"},
    {"id":"65536","name":"5 fluorouracil (IV use) : List of nationally authorised medicinal products - PSUSA/00000007/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-05T09:02:33Z","last_updated_date":"2024-11-05T09:02:33Z","reference_number":"EMA/224383/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/5-fluorouracil-iv-use-list-nationally-authorised-medicinal-products-psusa-00000007-202312_en.pdf"},
    {"id":"65526","name":"Metamizole : List of nationally authorised medicinal products - PSUSA/00001997/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-04T10:07:35Z","last_updated_date":"2024-11-04T10:07:35Z","reference_number":"EMA/509256/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/metamizole-list-nationally-authorised-medicinal-products-psusa-00001997-202403_en.pdf"},
    {"id":"65527","name":"Calcium chloride/glutamic acid/glutathione/histidine/lactobionic acid/magnesium chloride/mannitol/potassium chloride/sodium hydroxide : List of nationally authorised medicinal products - PSUSA/00009162/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-11-04T10:21:04Z","last_updated_date":"2024-11-04T10:21:04Z","reference_number":"EMA/510665/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/calcium-chloride-glutamic-acid-glutathione-histidine-lactobionic-acid-magnesium-chloride-mannitol-potassium-chloride-sodium-hydroxide-list-nationally-authorised-medicinal-products-psusa-00009162_en.pdf"},
    {"id":"65509","name":"Fluprednidene : List of nationally authorised medicinal products - PSUSA/00010097/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-31T15:46:07Z","last_updated_date":"2024-10-31T15:46:07Z","reference_number":"EMA/508765/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluprednidene-list-nationally-authorised-medicinal-products-psusa-00010097-202403_en.pdf"},
    {"id":"65508","name":"Olodaterol : List of nationally authorised medicinal products - PSUSA/00010245/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-31T15:32:24Z","last_updated_date":"2024-10-31T15:32:24Z","reference_number":"EMA/508740/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/olodaterol-list-nationally-authorised-medicinal-products-psusa-00010245-202403_en.pdf"},
    {"id":"65505","name":"Erythromycin (topical use) : List of nationally authorised medicinal products - PSUSA/00010809/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-31T14:36:24Z","last_updated_date":"2024-10-31T14:36:24Z","reference_number":"EMA/493558/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/erythromycin-topical-use-list-nationally-authorised-medicinal-products-psusa-00010809-202403_en.pdf"},
    {"id":"65504","name":"Fluprednidene / gentamicin : List of nationally authorised medicinal products - PSUSA/00010098/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-31T14:26:18Z","last_updated_date":"2024-10-31T14:26:18Z","reference_number":"EMA/493462/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluprednidene-gentamicin-list-nationally-authorised-medicinal-products-psusa-00010098-202403_en.pdf"},
    {"id":"65503","name":"Human anti-d immunoglobulin : List of nationally authorised medicinal products - PSUSA/00001614/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-31T14:20:32Z","last_updated_date":"2024-10-31T14:20:32Z","reference_number":"EMA/480206/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-anti-d-immunoglobulin-list-nationally-authorised-medicinal-products-psusa-00001614-202403_en.pdf"},
    {"id":"65474","name":"Amantadine : List of nationally authorised medicinal products - PSUSA/00000126/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-29T11:42:43Z","last_updated_date":"2024-10-29T11:42:43Z","reference_number":"EMA/500726/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/amantadine-list-nationally-authorised-medicinal-products-psusa-00000126-202401_en.pdf"},
    {"id":"65461","name":"Amitriptyline, amitriptyline / amitriptylinoxide, amitriptylinoxide: List of nationally authorised medicinal products -  PSUSA/00010374/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-28T16:00:00Z","last_updated_date":"2024-10-28T16:00:00Z","reference_number":"EMA/423920/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-amitriptyline-amitriptylinoxide-amitriptylinoxide-list-nationally-authorised-medicinal-products-psusa-00010374-202401_en.pdf"},
    {"id":"65452","name":"Valproic acid, sodium valproate, valproate pivoxil, valproate semisodium, valpromide, valproate bismuth, calcium valproate, valproate magnesium : List of nationally authorised medicinal products - PSUSA/00003090/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-28T10:38:00Z","last_updated_date":"2024-10-28T10:38:00Z","reference_number":"EMA/270645/2015","document_url":"https://www.ema.europa.eu/en/documents/psusa/valproic-acid-sodium-valproate-valproate-pivoxil-valproate-semisodium-valpromide-valproate-bismuth-calcium-valproate-valproate-magnesium-list-nationally-authorised-medicinal-products-psusa-00003090_en.pdf"},
    {"id":"65449","name":"Macrogol 3350 combinations (oral use) : List of nationally authorised medicinal products - PSUSA/00010705/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T15:19:00Z","last_updated_date":"2024-10-25T15:19:00Z","reference_number":"EMA/395372/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/macrogol-3350-combinations-oral-use-list-nationally-authorised-medicinal-products-psusa-00010705-202401_en.pdf"},
    {"id":"65436","name":"Amitriptyline / perphenazine : List of nationally authorised medicinal products - PSUSA/00000170/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-25T10:32:00Z","last_updated_date":"2024-10-25T10:32:00Z","reference_number":"EMA/497973/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/amitriptyline-perphenazine-list-nationally-authorised-medicinal-products-psusa-00000170-202401_en.pdf"},
    {"id":"65424","name":"Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-24T12:56:00Z","last_updated_date":"2024-10-24T12:56:00Z","reference_number":"EMA/496476/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/allopurinol-list-nationally-authorised-medicinal-products-psusa-00000095-202312_en.pdf"},
    {"id":"65322","name":"Galantamine : List of nationally authorised medicinal products - PSUSA/00001512/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-17T12:01:21Z","last_updated_date":"2024-10-17T12:01:21Z","reference_number":"EMA/483497/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/galantamine-list-nationally-authorised-medicinal-products-psusa-00001512-202403_en.pdf"},
    {"id":"65286","name":"Human coagulation factor VIII (inhibitor bypassing fraction) : List of nationally authorised medicinal products - PSUSA/00009174/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-11T16:37:00Z","last_updated_date":"2024-10-11T16:37:00Z","reference_number":"EMA/475430/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/human-coagulation-factor-viii-inhibitor-bypassing-fraction-list-nationally-authorised-medicinal-products-psusa-00009174-202402_en.pdf"},
    {"id":"65285","name":"Pentoxyverine : List of nationally authorised medicinal products - PSUSA/00002345/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-11T16:34:00Z","last_updated_date":"2024-10-11T16:34:00Z","reference_number":"EMA/475205/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/pentoxyverine-list-nationally-authorised-medicinal-products-psusa-00002345-202312_en.pdf"},
    {"id":"65284","name":"Ferric carboxymaltose (parenteral use) : List of nationally authorised medicinal products - PSUSA/00010865/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-11T16:31:00Z","last_updated_date":"2024-10-11T16:31:00Z","reference_number":"EMA/475270/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ferric-carboxymaltose-parenteral-use-list-nationally-authorised-medicinal-products-psusa-00010865-202401_en.pdf"},
    {"id":"65248","name":"Rupatadine : List of nationally authorised medicinal products - PSUSA/00002673/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T12:28:00Z","last_updated_date":"2024-10-09T12:28:00Z","reference_number":"EMA/470269/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/rupatadine-list-nationally-authorised-medicinal-products-psusa-00002673-202312_en.pdf"},
    {"id":"65247","name":"Iron sucrose (parenteral use) : List of nationally authorised medicinal products - PSUSA/00010864/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-09T11:47:00Z","last_updated_date":"2024-10-09T11:47:00Z","reference_number":"EMA/470193/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/iron-sucrose-parenteral-use-list-nationally-authorised-medicinal-products-psusa-00010864-202401_en.pdf"},
    {"id":"65235","name":"Ferric derisomaltose (parenteral use) : List of nationally authorised medicinal products - PSUSA/00010866/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-08T11:45:00Z","last_updated_date":"2024-10-08T11:45:00Z","reference_number":"EMA/467627/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ferric-derisomaltose-parenteral-use-list-nationally-authorised-medicinal-products-psusa-00010866-202401_en.pdf"},
    {"id":"65224","name":"Dorzolamide / timolol : List of nationally authorised medicinal products - PSUSA/00001166/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-07T16:14:00Z","last_updated_date":"2024-10-07T16:14:00Z","reference_number":"EMA/423872/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/dorzolamide-timolol-list-nationally-authorised-medicinal-products-psusa-00001166-202402_en.pdf"},
    {"id":"65223","name":"Sodium iron gluconate (parenteral use) : List of nationally authorised medicinal products - PSUSA/00010867/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-07T16:10:00Z","last_updated_date":"2024-10-07T16:10:00Z","reference_number":"EMA/466608/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/sodium-iron-gluconate-parenteral-use-list-nationally-authorised-medicinal-products-psusa-00010867-202401_en.pdf"},
    {"id":"65222","name":"Chlormadinone acetate / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000679/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-07T12:00:00Z","last_updated_date":"2024-10-07T12:00:00Z","reference_number":"EMA/466465/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlormadinone-acetate-ethinylestradiol-list-nationally-authorised-medicinal-products-psusa-00000679-202401_en.pdf"},
    {"id":"65221","name":"Sterculia, frangula / sterculia : List of nationally authorised medicinal products - PSUSA/00010428/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-07T16:03:00Z","last_updated_date":"2024-10-07T16:03:00Z","reference_number":"EMA/462766/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/sterculia-frangula-sterculia-list-nationally-authorised-medicinal-products-psusa-00010428-202402_en.pdf"},
    {"id":"65125","name":"Chlormadinone : List of nationally authorised medicinal products - PSUSA/00000677/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T13:14:00Z","last_updated_date":"2024-10-03T13:14:00Z","reference_number":"EMA/434956/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/chlormadinone-list-nationally-authorised-medicinal-products-psusa-00000677-202401_en.pdf"},
    {"id":"65144","name":"Ampicillin / sulbactam : List of nationally authorised medicinal products - PSUSA/00000197/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T16:05:00Z","last_updated_date":"2024-10-03T16:05:00Z","reference_number":"EMA/461916/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ampicillin-sulbactam-list-nationally-authorised-medicinal-products-psusa-00000197-202402_en.pdf"},
    {"id":"65131","name":"Lisdexamfetamine : List of nationally authorised medicinal products - PSUSA/00010289/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T14:46:00Z","last_updated_date":"2024-10-03T14:46:00Z","reference_number":"EMA/461260/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/lisdexamfetamine-list-nationally-authorised-medicinal-products-psusa-00010289-202402_en.pdf"},
    {"id":"65130","name":"Ondansetron : List of nationally authorised medicinal products - PSUSA/00002217/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T14:35:00Z","last_updated_date":"2024-10-03T14:35:00Z","reference_number":"EMA/268423/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ondansetron-list-nationally-authorised-medicinal-products-psusa-00002217-202402_en.pdf"},
    {"id":"65129","name":"Influenza vaccine (split virion, inactivated) (non centrally authorised products) : List of nationally authorised medicinal products - PSUSA/00010298/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T14:08:00Z","last_updated_date":"2024-10-03T14:08:00Z","reference_number":"EMA/435357/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-split-virion-inactivated-non-centrally-authorised-products-list-nationally-authorised-medicinal-products-psusa-00010298-202403_en.pdf"},
    {"id":"65128","name":"Flubendazole : List of nationally authorised medicinal products - PSUSA/00001400/202402","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T14:03:00Z","last_updated_date":"2024-10-03T14:03:00Z","reference_number":"EMA/435346/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/flubendazole-list-nationally-authorised-medicinal-products-psusa-00001400-202402_en.pdf"},
    {"id":"65127","name":"Influenza vaccine (surface antigen, inactivated) : List of nationally authorised medicinal products - PSUSA/00001744/202403","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T13:55:00Z","last_updated_date":"2024-10-03T13:55:00Z","reference_number":"EMA/435385/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/influenza-vaccine-surface-antigen-inactivated-list-nationally-authorised-medicinal-products-psusa-00001744-202403_en.pdf"},
    {"id":"65126","name":"Nomegestrol : List of nationally authorised medicinal products - PSUSA/00002181/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-10-03T13:51:00Z","last_updated_date":"2024-10-03T13:51:00Z","reference_number":"EMA/446952/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/nomegestrol-list-nationally-authorised-medicinal-products-psusa-00002181-202401_en.pdf"},
    {"id":"65023","name":"Cefpodoxim : List of nationally authorised medicinal products - PSUSA/00000604/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-25T15:00:00Z","last_updated_date":"2024-09-25T15:00:00Z","reference_number":"EMA/444611/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/cefpodoxim-list-nationally-authorised-medicinal-products-psusa-00000604-202312_en.pdf"},
    {"id":"64931","name":"Dexpanthenol : EPAR - List of nationally authorised medicinal products - PSUSA/00000999/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-19T11:15:00Z","last_updated_date":"2024-09-19T11:15:00Z","reference_number":"EMA/439633/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexpanthenol-epar-list-nationally-authorised-medicinal-products-psusa-00000999-202401_en.pdf"},
    {"id":"64814","name":"Levodropropizine : List of nationally authorised medicinal products - PSUSA/00001853/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-12T15:35:39Z","last_updated_date":"2024-09-12T15:35:39Z","reference_number":"EMA/428229/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/levodropropizine-list-nationally-authorised-medicinal-products-psusa-00001853-202401_en.pdf"},
    {"id":"64813","name":"Betahistine : List of nationally authorised medicinal products - PSUSA/00000389/202312 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-12T15:28:20Z","last_updated_date":"2024-09-12T15:28:20Z","reference_number":"EMA/428122/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/betahistine-list-nationally-authorised-medicinal-products-psusa-00000389-202312_en.pdf"},
    {"id":"64779","name":"Lormetazepam : List of nationally authorised medicinal products - PSUSA/00001910/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-10T16:01:00Z","last_updated_date":"2024-09-10T16:01:00Z","reference_number":"EMA/423653/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/lormetazepam-list-nationally-authorised-medicinal-products-psusa-00001910-202312_en.pdf"},
    {"id":"64776","name":"Pseudoephedrine / triprolidine : List of nationally authorised medicinal products - PSUSA/00003047/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-10T14:00:00Z","last_updated_date":"2024-09-10T14:00:00Z","reference_number":"EMA/423220/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/pseudoephedrine-triprolidine-list-nationally-authorised-medicinal-products-psusa-00003047-202312_en.pdf"},
    {"id":"64762","name":"Hydrochlorothiazide / spironolactone : List of nationally authorised medicinal products - PSUSA/00001662/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-09T12:25:23Z","last_updated_date":"2024-09-09T12:25:23Z","reference_number":"EMA/364990/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-spironolactone-list-nationally-authorised-medicinal-products-psusa-00001662-202401_en.pdf"},
    {"id":"64760","name":"Povidone iodinated : List of nationally authorised medicinal products - PSUSA/00002487/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-09T12:10:17Z","last_updated_date":"2024-09-09T12:10:17Z","reference_number":"EMA/365603/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/povidone-iodinated-list-nationally-authorised-medicinal-products-psusa-00002487-202401_en.pdf"},
    {"id":"64759","name":"Hepatitis A vaccines (inactivated, adsorbed) : List of nationally authorised medicinal products - PSUSA/00001596/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-09T11:55:10Z","last_updated_date":"2024-09-09T11:55:10Z","reference_number":"EMA/365619/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/hepatitis-vaccines-inactivated-adsorbed-list-nationally-authorised-medicinal-products-psusa-00001596-202401_en.pdf"},
    {"id":"64749","name":"Salicylic acid (topical use) : List of nationally authorised medicinal products - PSUSA/00002680/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T15:00:00Z","last_updated_date":"2024-09-06T15:00:00Z","reference_number":"EMA/419190/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/salicylic-acid-topical-use-list-nationally-authorised-medicinal-products-psusa-00002680-202312_en.pdf"},
    {"id":"64744","name":"Dapoxetine : List of nationally authorised medicinal products - PSUSA/00000928/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T14:27:00Z","last_updated_date":"2024-09-06T14:27:00Z","reference_number":"EMA/419119/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/dapoxetine-list-nationally-authorised-medicinal-products-psusa-00000928-202312_en.pdf"},
    {"id":"64743","name":"Altizide / spironolactone : List of nationally authorised medicinal products - PSUSA/00002781/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T14:23:00Z","last_updated_date":"2024-09-06T14:23:00Z","reference_number":"EMA/419122/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/altizide-spironolactone-list-nationally-authorised-medicinal-products-psusa-00002781-202401_en.pdf"},
    {"id":"64735","name":"Alitretinoin (oral use) : List of nationally authorised medicinal products - PSUSA/00010710/202401","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T11:32:28Z","last_updated_date":"2024-09-06T11:32:28Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/alitretinoin-oral-use-list-nationally-authorised-medicinal-products-psusa-00010710-202401_en.pdf"},
    {"id":"64731","name":"Codeine / ibuprofen : List of nationally authorised medicinal products - PSUSA/00000850/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-06T10:56:55Z","last_updated_date":"2024-09-06T10:56:55Z","reference_number":"EMA/415615/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/codeine-ibuprofen-list-nationally-authorised-medicinal-products-psusa-00000850-202312_en.pdf"},
    {"id":"64686","name":"Atomoxetine : List of nationally authorised medicinal products - PSUSA/00000262/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-03T11:19:49Z","last_updated_date":"2024-09-03T11:19:49Z","reference_number":"EMA/407133/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/atomoxetine-list-nationally-authorised-medicinal-products-psusa-00000262-202311_en.pdf"},
    {"id":"64676","name":"Glatiramer : List of nationally authorised medicinal products - PSUSA/00001529/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-09-02T09:56:26Z","last_updated_date":"2024-09-02T09:56:26Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/glatiramer-list-nationally-authorised-medicinal-products-psusa-00001529-202311_en.pdf"},
    {"id":"64658","name":"Methylprednisolone: List of nationally authorised medicinal products - PSUSA/00002026/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-08-29T14:40:07Z","last_updated_date":"2024-08-29T14:40:07Z","reference_number":"EMA/396973/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/methylprednisolone-list-nationally-authorised-medicinal-products-psusa-00002026-202311_en.pdf"},
    {"id":"64548","name":"Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-08-09T12:42:05Z","last_updated_date":"2024-08-09T12:42:05Z","reference_number":"EMA/370887/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/clevidipine-list-nationally-authorised-medicinal-products-psusa-00010288-202311_en.pdf"},
    {"id":"64640","name":"Hydroxycarbamide (except for centrally authorised product) : List of nationally authorised medicinal products - PSUSA/00009182/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-08-27T13:59:06Z","last_updated_date":"2024-08-27T13:59:06Z","reference_number":"EMA/330561/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxycarbamide-except-centrally-authorised-product-list-nationally-authorised-medicinal-products-psusa-00009182-202312_en.pdf"},
    {"id":"64627","name":"Hydrochlorothiazide / nebivolol : List of nationally authorised medicinal products - PSUSA/00001658/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-08-23T15:53:57Z","last_updated_date":"2024-08-23T15:53:57Z","reference_number":"EMA/391410/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydrochlorothiazide-nebivolol-list-nationally-authorised-medicinal-products-psusa-00001658-202311_en.pdf"},
    {"id":"64557","name":"Minoxidil (topical formulation): List of nationally authorised medicinal products - PSUSA/00002067/202310 ","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-08-13T09:43:48Z","last_updated_date":"2024-08-13T09:43:48Z","reference_number":"EMA/365078/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/minoxidil-topical-formulation-list-nationally-authorised-medicinal-products-psusa-00002067-202310_en.pdf"},
    {"id":"64244","name":"diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) / haemophilus type b conjugate vaccine (adsorbed) : List of nationally authorised medicinal products - PSUSA/00001124/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-19T16:12:00Z","last_updated_date":"2024-07-19T16:12:00Z","reference_number":"EMA/226886/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/diphtheria-tetanus-pertussis-acellular-component-poliomyelitis-inactivated-haemophilus-type-b-conjugate-vaccine-adsorbed-list-nationally-authorised-medicinal-products-psusa-00001124-202311_en.pdf"},
    {"id":"64184","name":"Flupentixol / melitracene : List of nationally authorised medicinal products - PSUSA/00001445/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-16T11:11:01Z","last_updated_date":"2024-07-16T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/flupentixol-melitracene-list-nationally-authorised-medicinal-products-psusa-00001445-202311_en.pdf"},
    {"id":"64182","name":"Ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., : List of nationally authorised medicinal products - PSUSA/00010800/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-16T11:11:01Z","last_updated_date":"2024-07-16T11:11:01Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/ethanol-extracts-iberis-amara-l-planta-tota-recens-angelica-archangelica-l-radix-matricaria-recutita-l-flos-carum-carvi-l-fructus-silybum-marianum-l-gaertn-list-nationally-authorised-medicinal_en.pdf"},
    {"id":"64176","name":"Levofloxacin (intravenous and oral use) : List of nationally authorised medicinal products - PSUSA/00010767/202310","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-16T17:00:00Z","last_updated_date":"2024-07-16T17:00:00Z","reference_number":"EMA/320231/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/levofloxacin-intravenous-oral-use-list-nationally-authorised-medicinal-products-psusa-00010767-202310_en.pdf"},
    {"id":"64169","name":"Tafluprost / timolol : List of nationally authorised medicinal products - PSUSA/00010324/202312","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-16T15:00:00Z","last_updated_date":"2024-07-16T15:00:00Z","reference_number":"EMA/320225/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/tafluprost-timolol-list-nationally-authorised-medicinal-products-psusa-00010324-202312_en.pdf"},
    {"id":"64175","name":"Flupentixol : List of nationally authorised medicinal products - PSUSA/00001444/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-16T00:00:00Z","last_updated_date":"2024-07-16T00:00:00Z","reference_number":"EMA/320228/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/flupentixol-list-nationally-authorised-medicinal-products-psusa-00001444-202311_en.pdf"},
    {"id":"64120","name":"Baclofen (oral use, for muscle spasticity indication) : List of nationally authorised medicinal products - PSUSA/00000294/202309","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T16:25:00Z","last_updated_date":"2024-07-12T16:25:00Z","reference_number":"EMA/320173/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/baclofen-oral-use-muscle-spasticity-indication-list-nationally-authorised-medicinal-products-psusa-00000294-202309_en.pdf"},
    {"id":"64081","name":"Acitretin : List of nationally authorised medicinal products - PSUSA/00000051/202310","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-12T13:57:00Z","last_updated_date":"2024-07-12T13:57:00Z","reference_number":"EMA/325484/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/acitretin-list-nationally-authorised-medicinal-products-psusa-00000051-202310_en.pdf"},
    {"id":"63885","name":"Adapalene / benzoyl peroxide : List of nationally authorised medicinal products - PSUSA/00000059/202309","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T09:17:00Z","last_updated_date":"2024-07-05T09:17:00Z","reference_number":"EMA/186512/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/adapalene-benzoyl-peroxide-list-nationally-authorised-medicinal-products-psusa-00000059-202309_en.pdf"},
    {"id":"63882","name":"Diclofenac (topical formulations) : List of nationally authorised medicinal products - PSUSA/00010342/202309","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-07-05T09:10:00Z","last_updated_date":"2024-07-05T09:10:00Z","reference_number":"EMA/302227/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/diclofenac-topical-formulations-list-nationally-authorised-medicinal-products-psusa-00010342-202309_en.pdf"},
    {"id":"63676","name":"Etifoxine: List of nationally authorised medicinal products - PSUSA/00001321/202310","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T17:29:57Z","last_updated_date":"2024-06-18T17:29:57Z","reference_number":"EMA/275078/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/etifoxine-list-nationally-authorised-medicinal-products-psusa-00001321-202310_en.pdf"},
    {"id":"63670","name":"Methacholine : List of nationally authorised medicinal products - PSUSA/00010891/202310","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-18T14:38:00Z","last_updated_date":"2024-06-18T14:38:00Z","reference_number":"EMA/282355/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/methacholine-list-nationally-authorised-medicinal-products-psusa-00010891-202310_en.pdf"},
    {"id":"63652","name":"Ascorbic acid / chlorphenamine maleate / paracetamol : List of nationally authorised medicinal products - PSUSA/00000696/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-17T13:55:00Z","last_updated_date":"2024-06-17T13:55:00Z","reference_number":"EMA/273650/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ascorbic-acid-chlorphenamine-maleate-paracetamol-list-nationally-authorised-medicinal-products-psusa-00000696-202311_en.pdf"},
    {"id":"63651","name":"Hydroxyzine, hydroxyzine combination : List of nationally authorised medicinal products - PSUSA/00001696/202311","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-17T13:40:00Z","last_updated_date":"2024-06-17T13:40:00Z","reference_number":"EMA/275072/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/hydroxyzine-hydroxyzine-combination-list-nationally-authorised-medicinal-products-psusa-00001696-202311_en.pdf"},
    {"id":"63567","name":"Lithium : List of nationally authorised medicinal products - PSUSA/00001897/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-11T13:44:00Z","last_updated_date":"2024-06-11T13:44:00Z","reference_number":"EMA/159597/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/lithium-list-nationally-authorised-medicinal-products-psusa-00001897-202308_en.pdf"},
    {"id":"63564","name":"Naproxen : List of nationally authorised medicinal products - PSUSA/00002125/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-11T13:36:00Z","last_updated_date":"2024-06-11T13:36:00Z","reference_number":"EMA/272182/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/naproxen-list-nationally-authorised-medicinal-products-psusa-00002125-202308_en.pdf"},
    {"id":"63502","name":"Trimetazidine : List of nationally authorised medicinal products - PSUSA/00003043/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-06T09:54:00Z","last_updated_date":"2024-06-06T09:54:00Z","reference_number":"EMA/263401/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/trimetazidine-list-nationally-authorised-medicinal-products-psusa-00003043-202308_en.pdf"},
    {"id":"63472","name":"Naloxone / oxycodone : List of nationally authorised medicinal products - PSUSA/00002114/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-06-04T12:45:00Z","last_updated_date":"2024-06-04T12:45:00Z","reference_number":"EMA/255632/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/naloxone-oxycodone-list-nationally-authorised-medicinal-products-psusa-00002114-202308_en.pdf"},
    {"id":"63383","name":"Dexibuprofen : List of nationally authorised medicinal products - PSUSA/00000996/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-05-30T11:00:39Z","last_updated_date":"2024-05-30T11:00:39Z","reference_number":"EMA/221424/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/dexibuprofen-list-nationally-authorised-medicinal-products-psusa-00000996-202308_en.pdf"},
    {"id":"63254","name":"Levofloxacin (ocular use) : List of nationally authorised medicinal products - PSUSA/00010768/202310","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-05-17T13:21:00Z","last_updated_date":"2024-05-17T13:21:00Z","reference_number":"EMA/121791/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/levofloxacin-ocular-use-list-nationally-authorised-medicinal-products-psusa-00010768-202310_en.pdf"},
    {"id":"63238","name":"Acetylcysteine : List of nationally authorised medicinal products - PSUSA/00000034/202309","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-05-16T14:44:00Z","last_updated_date":"2024-05-16T14:44:00Z","reference_number":"EMA/235059/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/acetylcysteine-list-nationally-authorised-medicinal-products-psusa-00000034-202309_en.pdf"},
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    {"id":"63152","name":"Quetiapine : List of nationally authorised medicinal products - PSUSA/00002589/202307","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-05-03T13:35:00Z","last_updated_date":"2024-05-03T13:35:00Z","reference_number":"EMA/189486/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/quetiapine-list-nationally-authorised-medicinal-products-psusa-00002589-202307_en.pdf"},
    {"id":"63041","name":"Inosine pranobex : List of nationally authorised medicinal products - PSUSA/00010425/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-22T16:27:04Z","last_updated_date":"2024-04-22T16:27:04Z","reference_number":"EMA/174062/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/inosine-pranobex-list-nationally-authorised-medicinal-products-psusa-00010425-202308_en.pdf"},
    {"id":"62954","name":"Trazodone : List of nationally authorised medicinal products - PSUSA/00003012/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-15T13:19:00Z","last_updated_date":"2024-04-15T13:19:00Z","reference_number":"EMA/144698/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/trazodone-list-nationally-authorised-medicinal-products-psusa-00003012-202308_en.pdf"},
    {"id":"62989","name":"Ipratropium / xylometazoline : List of nationally authorised medicinal products - PSUSA/00009201/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-17T15:35:49Z","last_updated_date":"2024-04-17T15:35:49Z","reference_number":"EMA/167330/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ipratropium-xylometazoline-list-nationally-authorised-medicinal-products-psusa-00009201-202308_en.pdf"},
    {"id":"62962","name":"Fluocinolone acetonide (intravitreal implant in applicator) : List of nationally authorised medicinal products - PSUSA/00010224/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-15T16:13:51Z","last_updated_date":"2024-04-15T16:13:51Z","reference_number":"EMA/160607/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/fluocinolone-acetonide-intravitreal-implant-applicator-list-nationally-authorised-medicinal-products-psusa-00010224-202308_en.pdf"},
    {"id":"62961","name":"Modafinil : List of nationally authorised medicinal products - PSUSA/00010242/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-15T16:10:22Z","last_updated_date":"2024-04-15T16:10:22Z","reference_number":"EMA/160525/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/modafinil-list-nationally-authorised-medicinal-products-psusa-00010242-202308_en.pdf"},
    {"id":"62959","name":"Zolpidem : List of nationally authorised medicinal products - PSUSA-00003151-202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-15T15:18:49Z","last_updated_date":"2024-04-15T15:18:49Z","reference_number":"EMA/160401/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/zolpidem-list-nationally-authorised-medicinal-products-psusa-00003151-202308_en.pdf"},
    {"id":"62955","name":"Phenytoin : List of nationally authorised medicinal products - PSUSA/00002392/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-15T13:26:53Z","last_updated_date":"2024-04-15T13:26:53Z","reference_number":"EMA/144701/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/phenytoin-list-nationally-authorised-medicinal-products-psusa-00002392-202308_en.pdf"},
    {"id":"62921","name":"Finasteride : List of nationally authorised medicinal products - PSUSA/00001392/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-11T14:46:12Z","last_updated_date":"2024-04-11T14:46:12Z","reference_number":"EMA/155021/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/finasteride-list-nationally-authorised-medicinal-products-psusa-00001392-202308_en.pdf"},
    {"id":"62832","name":"Paracetamol / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00002307/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-04T16:06:15Z","last_updated_date":"2024-04-04T16:06:15Z","reference_number":"EMA/145166/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/paracetamol-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa-00002307-202306_en.pdf"},
    {"id":"62830","name":"Ibuprofen / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00001711/202307","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-04T15:58:27Z","last_updated_date":"2024-04-04T15:58:27Z","reference_number":"EMA/145084/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ibuprofen-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa-00001711-202307_en.pdf"},
    {"id":"62809","name":"Rizatriptan : List of nationally authorised medicinal products - PSUSA/00002655/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-04T13:51:59Z","last_updated_date":"2024-04-04T13:51:59Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/rizatriptan-list-nationally-authorised-medicinal-products-psusa-00002655-202306_en.pdf"},
    {"id":"62802","name":"Tramadol : List of nationally authorised medicinal products - PSUSA/00003002/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-04T11:31:06Z","last_updated_date":"2024-04-04T11:31:06Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/tramadol-list-nationally-authorised-medicinal-products-psusa-00003002-202306_en.pdf"},
    {"id":"62784","name":"Oxycodone hydrochloride / paracetamol : List of nationally authorised medicinal products - PSUSA/00002256/202307","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-03T11:06:46Z","last_updated_date":"2024-04-03T11:06:46Z","reference_number":"EMA/124914/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/oxycodone-hydrochloride-paracetamol-list-nationally-authorised-medicinal-products-psusa-00002256-202307_en.pdf"},
    {"id":"62779","name":"Nimesulide (topical formulations) : List of nationally authorised medicinal products - PSUSA/00002655/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-02T13:53:45Z","last_updated_date":"2024-04-02T13:53:45Z","reference_number":"EMA/94455/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/nimesulide-topical-formulations-list-nationally-authorised-medicinal-products-psusa-00002655-202306_en.pdf"},
    {"id":"62766","name":"Mifepristone/Misoprostol: List of nationally authorised medicinal products - PSUSA-00010378-202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-04-02T10:35:27Z","last_updated_date":"2024-04-02T10:35:27Z","reference_number":"EMA/PRAC/4056/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/mifepristone-misoprostol-list-nationally-authorised-medicinal-products-psusa-00010378-202305_en.pdf-0"},
    {"id":"62583","name":"Chlormadinone acetate (CMA), ethinylestradiol (EE) : List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0042","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-03-13T09:10:43Z","last_updated_date":"2024-03-13T09:10:43Z","reference_number":"EMA/111641/2024","document_url":"https://www.ema.europa.eu/en/documents/other/chlormadinone-acetate-cma-ethinylestradiol-ee-list-nationally-authorised-medicinal-products-emea-h-n-psr-j-0042_en.pdf"},
    {"id":"62617","name":"Mifepristone : List of nationally authorised medicinal products - PSUSA/00002060/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-15T10:57:57Z","last_updated_date":"2024-03-15T10:57:57Z","reference_number":"EMA/115648/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/mifepristone-list-nationally-authorised-medicinal-products-psusa-00002060-202305_en.pdf"},
    {"id":"62523","name":"Ribavirin: List of nationally authorised medicinal products - PSUSA/00010007/202307","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T16:50:25Z","last_updated_date":"2024-03-08T16:50:25Z","reference_number":"EMA/104321/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/ribavirin-list-nationally-authorised-medicinal-products-psusa-00010007-202307_en.pdf"},
    {"id":"62498","name":"Indometacin : List of nationally authorised medicinal products - PSUSA/00001738/202307","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-08T15:35:10Z","last_updated_date":"2024-03-08T15:35:10Z","reference_number":"EMA/106682/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/indometacin-list-nationally-authorised-medicinal-products-psusa-00001738-202307_en.pdf"},
    {"id":"62467","name":"Niclosamide : List of nationally authorised medicinal products - PSUSA/00002151/202308","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-07T12:31:27Z","last_updated_date":"2024-03-07T12:31:27Z","reference_number":"EMA/21937/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/niclosamide-list-nationally-authorised-medicinal-products-psusa-00002151-202308_en.pdf"},
    {"id":"62447","name":"Gadopentetic acid : List of nationally authorised medicinal products - PSUSA/00001504/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-06T12:53:25Z","last_updated_date":"2024-03-06T12:53:25Z","reference_number":"EMA/27098/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadopentetic-acid-list-nationally-authorised-medicinal-products-psusa-00001504-202304_en.pdf"},
    {"id":"62429","name":"Gadoteric acid (IV and intravascular formulations) : List of nationally authorised medicinal products - PSUSA/00001506/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-04T16:14:08Z","last_updated_date":"2024-03-04T16:14:08Z","reference_number":"EMA/95353/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteric-acid-iv-intravascular-formulations-list-nationally-authorised-medicinal-products-psusa-00001506-202304_en.pdf"},
    {"id":"62409","name":"Nalbuphine : List of nationally authorised medicinal products - PSUSA-00002110-202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-01T16:24:14Z","last_updated_date":"2024-03-01T16:24:14Z","reference_number":"EMA/94832/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/nalbuphine-list-nationally-authorised-medicinal-products-psusa-00002110-202305_en.pdf"},
    {"id":"62405","name":"Ceftriaxone : List of nationally authorised medicinal products - PSUSA/00000613/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-01T16:14:28Z","last_updated_date":"2024-03-01T16:14:28Z","reference_number":"EMA/509005/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/ceftriaxone-list-nationally-authorised-medicinal-products-psusa-00000613-202305_en.pdf"},
    {"id":"62403","name":"Gadobenic acid : List of nationally authorised medicinal products - PSUSA/00001500/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-03-01T16:07:24Z","last_updated_date":"2024-03-01T16:07:24Z","reference_number":"EMA/94339/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadobenic-acid-list-nationally-authorised-medicinal-products-psusa-00001500-202304_en.pdf"},
    {"id":"62365","name":"Moxifloxacin (systemic use) : List of nationally authorised medicinal products - PSUSA/00009231/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T15:58:54Z","last_updated_date":"2024-02-29T15:58:54Z","reference_number":"EMA/15401/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/moxifloxacin-systemic-use-list-nationally-authorised-medicinal-products-psusa-00009231-202305_en.pdf"},
    {"id":"62356","name":"Gadobutrol : List of nationally authorised medicinal products - PSUSA/00001502/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T11:37:04Z","last_updated_date":"2024-02-29T11:37:04Z","reference_number":"EMA/49544/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadobutrol-list-nationally-authorised-medicinal-products-psusa-00001502-202304_en.pdf"},
    {"id":"62354","name":"Gadoxetic acid disodium :  List of nationally authorised medicinal products - PSUSA/00001509/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T11:24:50Z","last_updated_date":"2024-02-29T11:24:50Z","reference_number":"EMA/49699/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoxetic-acid-disodium-list-nationally-authorised-medicinal-products-psusa-00001509-202304_en.pdf"},
    {"id":"62350","name":"Gadoteridol : List of nationally authorised medicinal products - PSUSA/00001507/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-29T09:09:40Z","last_updated_date":"2024-02-29T09:09:40Z","reference_number":"EMA/90538/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/gadoteridol-list-nationally-authorised-medicinal-products-psusa-00001507-202304_en.pdf"},
    {"id":"62247","name":"Valproate : List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0043","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-02-21T17:28:14Z","last_updated_date":"2024-02-21T17:28:14Z","reference_number":"EMA/581954/2023","document_url":"https://www.ema.europa.eu/en/documents/other/valproate-list-nationally-authorised-medicinal-products-emea-h-n-psr-j-0043_en.pdf"},
    {"id":"62073","name":"Pseudoephedrine, acetylsalicylic acid / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00010667/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-12T13:25:31Z","last_updated_date":"2024-02-12T13:25:31Z","reference_number":"EMA/65114/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/pseudoephedrine-acetylsalicylic-acid-pseudoephedrine-list-nationally-authorised-medicinal-products-psusa-00010667-202306_en.pdf"},
    {"id":"62066","name":"Hepatitis a (inactivated) / typhoid polysaccharide vaccine (adsorbed) : List of nationally authorised medicinal products - PSUSA/00001594/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-09T15:52:50Z","last_updated_date":"2024-02-09T15:52:50Z","reference_number":"EMA/571599/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/hepatitis-inactivated-typhoid-polysaccharide-vaccine-adsorbed-list-nationally-authorised-medicinal-products-psusa-00001594-202306_en.pdf"},
    {"id":"62065","name":"Misoprostol (gastrointestinal indication) : List of nationally authorised medicinal products - PSUSA/00010291/202306","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-09T15:47:35Z","last_updated_date":"2024-02-09T15:47:35Z","reference_number":"EMA/61133/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/misoprostol-gastrointestinal-indication-list-nationally-authorised-medicinal-products-psusa-00010291-202306_en.pdf"},
    {"id":"62064","name":"Allergen for therapy: betula verrucosa (sublingual use) : List of nationally authorised medicinal products - PSUSA/00010815/202307","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-09T15:41:53Z","last_updated_date":"2024-02-09T15:41:53Z","reference_number":"EMA/60890/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/allergen-therapy-betula-verrucosa-sublingual-use-list-nationally-authorised-medicinal-products-psusa-00010815-202307_en.pdf"},
    {"id":"62013","name":"Fentanyl (transdermal patches, solution for injection - nationally authorised product only) : List of nationally authorised medicinal products - PSUSA/00001370/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-02-06T15:05:32Z","last_updated_date":"2024-02-06T15:05:32Z","reference_number":"EMA/51342/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/fentanyl-transdermal-patches-solution-injection-nationally-authorised-product-only-list-nationally-authorised-medicinal-products-psusa-00001370-202304_en.pdf"},
    {"id":"61954","name":"Racecadotril : List of nationally authorised medicinal products - PSUSA/00002602/202303","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-30T17:05:11Z","last_updated_date":"2024-01-30T17:05:11Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/racecadotril-list-nationally-authorised-medicinal-products-psusa-00002602-202303_en.pdf"},
    {"id":"61893","name":"Aceclofenac : List of nationally authorised medicinal products  - PSUSA/00000022/202303","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-25T16:17:19Z","last_updated_date":"2024-01-25T16:17:19Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/aceclofenac-list-nationally-authorised-medicinal-products-psusa-00000022-202303_en.pdf"},
    {"id":"61888","name":"Aprotinin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0030","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-25T13:41:58Z","last_updated_date":"2024-01-25T13:41:58Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/psusa/aprotinin-list-nationally-authorised-medicinal-products-emea-h-n-psr-s-0030_en.pdf"},
    {"id":"61864","name":"Piroxicam : List of nationally authorised medicinal products - PSUSA/00002438/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-24T12:44:50Z","last_updated_date":"2024-01-24T12:44:50Z","reference_number":"EMA/37809/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/piroxicam-list-nationally-authorised-medicinal-products-psusa-00002438-202304_en.pdf"},
    {"id":"61859","name":"Venlafaxine : List of nationally authorised medicinal products - PSUSA/00003104/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-24T10:35:26Z","last_updated_date":"2024-01-24T10:35:26Z","reference_number":"EMA/555773/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/venlafaxine-list-nationally-authorised-medicinal-products-psusa-00003104-202305_en.pdf"},
    {"id":"61857","name":"Clarithromycin : List of nationally authorised medicinal products - PSUSA/00000788/202304","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-24T10:29:25Z","last_updated_date":"2024-01-24T10:29:25Z","reference_number":"EMA/515639/2023","document_url":"https://www.ema.europa.eu/en/documents/psusa/clarithromycin-list-nationally-authorised-medicinal-products-psusa-00000788-202304_en.pdf"},
    {"id":"61851","name":"Pravastatin : List of nationally authorised medicinal products - PSUSA/00002500/202303","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-23T17:19:36Z","last_updated_date":"2024-01-23T17:19:36Z","reference_number":"EMA/35243/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/pravastatin-list-nationally-authorised-medicinal-products-psusa-00002500-202303_en.pdf"},
    {"id":"61844","name":"Mometasone : List of nationally authorised medicinal products - PSUSA/00002085/202305","type":"psusa","status":"unknown","consultation_date":"","first_published_date":"2024-01-23T14:13:08Z","last_updated_date":"2024-01-23T14:13:08Z","reference_number":"EMA/34986/2024","document_url":"https://www.ema.europa.eu/en/documents/psusa/mometasone-list-nationally-authorised-medicinal-products-psusa-00002085-202305_en.pdf"},
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    {"id":"68879","name":"Sodium oxybate Article-31 referral - Timetable for the procedure","type":"referral","status":"unknown","consultation_date":"","first_published_date":"2025-06-20T17:39:25Z","last_updated_date":"2026-03-02T09:40:00Z","reference_number":"EMADOC-1700519818-2230331 Rev. 2","document_url":"https://www.ema.europa.eu/en/documents/referral/sodium-oxybate-article-31-referral-timetable-procedure_en.pdf"},
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    {"id":"72777","name":"Agenda - European Medicines Agency (EMA) - European Alliance of Associations for Rheumatology (EULAR) bilateral meeting - March 2026","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2026-03-02T16:10:04Z","last_updated_date":"2026-03-02T16:10:04Z","reference_number":"EMA/13450/2026","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-european-medicines-agency-ema-european-alliance-associations-rheumatology-eular-bilateral-meeting-march-2026_en.pdf"},
    {"id":"69219","name":"Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-07-10 - 2025-10-31","first_published_date":"2025-07-10T10:12:09Z","last_updated_date":"2025-07-10T10:12:09Z","reference_number":"EMA/151695/2025 Rev. 1","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-dronedarone-film-coated-tablets-400-mg-product-specific-bioequivalence-guidance-revision-1_en.pdf"},
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    {"id":"72926","name":"EMEA-003532-PIP01-23 : EMA decision of 28 January 2025 on the granting of a product specific waiver for budigalimab","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2026-03-11T13:24:50Z","last_updated_date":"2026-03-11T13:24:50Z","reference_number":"EMADOC-1700519818-1859887","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/emea-003532-pip01-23-ema-decision-28-january-2025-granting-product-specific-waiver-budigalimab_en.pdf"},
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    {"id":"72944","name":"EMEA-002886-PIP03-24 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for rocatinlimab","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2026-03-11T13:46:14Z","last_updated_date":"2026-03-11T13:46:14Z","reference_number":"EMA/581540/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/emea-002886-pip03-24-ema-decision-3-january-2025-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-rocatinlimab_en.pdf"},
    {"id":"72945","name":"P/0400/2024 : EMA decision of 3 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for golcadomide (EMEA-003161-PIP02-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2026-03-11T13:49:31Z","last_updated_date":"2026-03-11T13:49:31Z","reference_number":"EMA/566316/2024","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0400-2024-ema-decision-3-january-2025-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-golcadomide-emea-003161-pip02-24_en.pdf"},
    {"id":"72946","name":"EMA/PE/0000224110 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for esketamine (hydrochloride)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2026-03-11T14:00:43Z","last_updated_date":"2026-03-11T14:00:43Z","reference_number":"EMADOC-1700519818-1859738","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/ema-pe-0000224110-ema-decision-28-january-2025-acceptance-modification-agreed-paediatric-investigation-plan-esketamine-hydrochloride_en.pdf"},
    {"id":"72947","name":"P/0006/2025 : EMA decision of 27 January 2025 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for luliconazole (EMEA-003604-PIP01-24)","type":"pip-decision","status":"Adopted","consultation_date":"","first_published_date":"2026-03-11T14:50:01Z","last_updated_date":"2026-03-11T14:50:01Z","reference_number":"EMA/25301/2025","document_url":"https://www.ema.europa.eu/en/documents/pip-decision/p-0006-2025-ema-decision-27-january-2025-agreement-paediatric-investigation-plan-granting-deferral-granting-waiver-luliconazole-emea-003604-pip01-24_en.pdf"},
    {"id":"72949","name":"Minutes of the PRAC meeting 12 - 15 January 2026","type":"minutes","status":"Adopted","consultation_date":"","first_published_date":"2026-03-11T15:11:40Z","last_updated_date":"2026-03-11T15:11:40Z","reference_number":"EMA/PRAC/46601/2026","document_url":"https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-12-15-january-2026_en.pdf"},
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    {"id":"72712","name":"Melatomed Article 29(4) referral - Public assessment report including divergent positions to CHMP opinion","type":"referral","status":"Adopted","consultation_date":"","first_published_date":"2026-02-26T10:14:51Z","last_updated_date":"2026-02-26T10:14:51Z","reference_number":"EMADOC-1700519818-2909554","document_url":"https://www.ema.europa.eu/en/documents/referral/melatomed-article-294-referral-public-assessment-report-including-divergent-positions-chmp-opinion_en.pdf"},
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    {"id":"73083","name":"Presentation - Legislative initiatives with impact on veterinary medicines (C.Philippe, Boehringer Ingelheim / Animal Health Europe)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2026-03-17T17:37:14Z","last_updated_date":"2026-03-17T17:37:14Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-legislative-initiatives-impact-veterinary-medicines-cphilippe-boehringer-ingelheim-animal-health-europe_en.pdf"},
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    {"id":"73094","name":"Presentation - Veterinary medicinal products in the Biotech Act (R.Salvador Roldan, DG SANTE)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2026-03-17T17:48:02Z","last_updated_date":"2026-03-17T17:48:02Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-veterinary-medicinal-products-biotech-act-rsalvador-roldan-dg-sante_en.pdf"},
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    {"id":"65905","name":"Presentation - HTA Regulation - Joint scientific consultations and joint clinical assessment (P.Rivetti di Val Cervo, AIFA)","type":"presentation","status":"unknown","consultation_date":"","first_published_date":"2024-12-03T09:44:23Z","last_updated_date":"2024-12-03T09:44:23Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/presentation/presentation-hta-regulation-joint-scientific-consultations-joint-clinical-assessment-privetti-di-val-cervo-aifa_en.pdf"},
    {"id":"49471","name":"Mosquirix: Risk management plan","type":"outside-EU-rmp-summary","status":"unknown","consultation_date":"","first_published_date":"2015-10-01T11:50:00Z","last_updated_date":"2026-03-18T11:01:00Z","reference_number":"","document_url":"https://www.ema.europa.eu/en/documents/outside-eu-rmp-summary/mosquirix-risk-management-plan_en.pdf"},
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    {"id":"55252","name":"Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)","type":"other","status":"unknown","consultation_date":"","first_published_date":"2022-06-15T17:33:00Z","last_updated_date":"2026-04-20T09:00:00Z","reference_number":"EMA/819958/2022-Rev.3","document_url":"https://www.ema.europa.eu/en/documents/other/validation-checklist-initial-marketing-authorisation-applications-biologicals-other-immunologicals-applicable-submissions-under-regulation-eu-2019-6_en.pdf"},
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    {"id":"61958","name":"Process for submitting existing data on medicinal products authorised for human use – SIAMED II & XEVMPD to PMS deltas - Chapter 9","type":"other","status":"unknown","consultation_date":"","first_published_date":"2024-01-30T17:43:01Z","last_updated_date":"2026-04-21T10:20:00Z","reference_number":"EMA/8748/2024","document_url":"https://www.ema.europa.eu/en/documents/other/process-submitting-existing-data-medicinal-products-authorised-human-use-siamed-ii-xevmpd-pms-deltas-chapter-9_en.pdf"},
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    {"id":"73558","name":"Questions and answers on the outcome of assessment on use of Opdualag in the treatment of advanced melanoma","type":"chmp-annex","status":"Adopted","consultation_date":"","first_published_date":"2026-04-24T12:00:00Z","last_updated_date":"2026-04-24T12:00:00Z","reference_number":"EMA/89906/2026","document_url":"https://www.ema.europa.eu/en/documents/chmp-annex/questions-answers-outcome-assessment-use-opdualag-treatment-advanced-melanoma_en.pdf"},
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    {"id":"73338","name":"Agenda - EMA and European Association of Nuclear Medicine (EANM)  bilateral meeting  ","type":"agenda","status":"Draft","consultation_date":"","first_published_date":"2026-04-07T15:58:48Z","last_updated_date":"2026-04-07T15:58:48Z","reference_number":"EMA/78026/2026 ","document_url":"https://www.ema.europa.eu/en/documents/agenda/agenda-ema-european-association-nuclear-medicine-eanm-bilateral-meeting_en.pdf"},
    {"id":"73583","name":"Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2","type":"scientific-guideline","status":"Draft: consultation open","consultation_date":"2026-04-29 - 2026-06-30","first_published_date":"2026-04-29T13:27:24Z","last_updated_date":"2026-04-29T13:27:24Z","reference_number":"CPMP/QWP/450/03 Rev.2; EMEA/CVMP/511/03 Rev.2","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/annexes-ich-q3c-guideline-impurities-guideline-residual-solvents-ema-chmp-ich-82260-2006-vich-gl18-impurities-residual-solvents-new-veterinary-medicinal-products-active-substances-excipients-ema-cvmp_en.pdf"},
    {"id":"73590","name":"Tafamidis soft gelatin capsules 20 mg and 61 mg product-specific bioequivalence guidance","type":"scientific-guideline","status":"Draft: consultation open","consultation_date":"2026-04-30 - 2026-07-31","first_published_date":"2026-04-30T12:21:34Z","last_updated_date":"2026-04-30T12:21:34Z","reference_number":"EMA/85747/2026","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/tafamidis-soft-gelatin-capsules-20-mg-61-mg-product-specific-bioequivalence-guidance_en.pdf"},
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    {"id":"70799","name":"Draft guideline on quality aspects of phage therapy medicinal products","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2025-10-23 - 2026-04-30","first_published_date":"2025-10-24T08:56:58Z","last_updated_date":"2025-10-24T08:56:58Z","reference_number":"EMA/CHMP/BWP/1/2024","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-phage-therapy-medicinal-products_en.pdf"},
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    {"id":"72825","name":"Draft guidance on the conduct of clinical trials during public health emergencies","type":"scientific-guideline","status":"Draft: consultation closed","consultation_date":"2026-03-04 - 2026-04-30","first_published_date":"2026-03-04T13:19:18Z","last_updated_date":"2026-03-04T13:19:18Z","reference_number":"EMA/44884/2026","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guidance-conduct-clinical-trials-during-public-health-emergencies_en.pdf"},
    {"id":"73570","name":"Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products","type":"scientific-guideline","status":"Draft: consultation open","consultation_date":"2026-04-24 - 2026-07-31","first_published_date":"2026-04-24T11:44:06Z","last_updated_date":"2026-04-24T11:44:06Z","reference_number":"EMA/CVMP/121133/2025","document_url":"https://www.ema.europa.eu/en/documents/scientific-guideline/draft-concept-paper-development-guidance-demonstration-biosimilarity-biological-veterinary-medicinal-products_en.pdf"},
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